Riverside Community Hospital

123 CMS Violations since 2011-04-27

• Medicare ID: 050022
• Type Of Facility: Short Term Acute Care
• Address: 4445 Magnolia Avenue Riverside, CA 92501

Immediate Jeopardy Violations

Violation Name: INTEGRATION OF EMERGENCY SERVICES(A-1103)

• Inspection Date: 2019-04-11 (Event ID: TGS511)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

Non Immediate Jeopardy Violations

Violation Name: MEDICAL STAFF(A-0338)

• Inspection Date: 2023-01-20 (Event ID: EBO311)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

Violation Name: MEDICAL STAFF BYLAWS(A-0353)

• Inspection Date: 2023-01-20 (Event ID: EBO311)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

Violation Name: NURSING SERVICES(A-0385)

• Inspection Date: 2023-01-20 (Event ID: EBO311)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

Violation Name: STAFFING AND DELIVERY OF CARE(A-0392)

• Inspection Date: 2023-01-20 (Event ID: EBO311)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

Violation Name: SUPERVISION OF CONTRACT STAFF(A-0398)

• Inspection Date: 2023-01-20 (Event ID: EBO311)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

Violation Name: SURGICAL SERVICES(A-0940)

• Inspection Date: 2023-01-20 (Event ID: EBO311)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

Violation Name: OPERATING ROOM POLICIES(A-0951)

• Inspection Date: 2023-01-20 (Event ID: EBO311)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

Violation Name: ADMINISTRATION OF DRUGS(A-0405)

• Inspection Date: 2023-01-20 (Event ID: EBO311)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

Violation Name: PATIENT RIGHTS(A-0115)

• Inspection Date: 2019-05-23 (Event ID: QGY311)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

Violation Name: PATIENT RIGHTS: RESTRAINT OR SECLUSION(A-0178)

• Inspection Date: 2019-05-23 (Event ID: QGY311)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

Violation Name: PATIENT RIGHTS: RESTRAINT OR SECLUSION(A-0179)

• Inspection Date: 2019-05-23 (Event ID: QGY311)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

Violation Name: Means of Egress - General(K-0211)

• Inspection Date: 2019-05-23 (Event ID: QGY321)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

Violation Name: Doors with Self-Closing Devices(K-0223)

• Inspection Date: 2019-05-23 (Event ID: QGY321)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

Violation Name: Exit Signage(K-0293)

• Inspection Date: 2019-05-23 (Event ID: QGY321)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

Violation Name: Hazardous Areas - Enclosure(K-0321)

• Inspection Date: 2019-05-23 (Event ID: QGY321)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

Violation Name: Fire Alarm System - Notification(K-0343)

• Inspection Date: 2019-05-23 (Event ID: QGY321)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

Violation Name: Fire Alarm System - Testing and Maintenance(K-0345)

• Inspection Date: 2019-05-23 (Event ID: QGY321)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

Violation Name: Sprinkler System - Maintenance and Testing(K-0353)

• Inspection Date: 2019-05-23 (Event ID: QGY321)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

Violation Name: Portable Fire Extinguishers(K-0355)

• Inspection Date: 2019-05-23 (Event ID: QGY321)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

Violation Name: RN SUPERVISION OF NURSING CARE(A-0395)

• Inspection Date: 2019-05-23 (Event ID: QGY311)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

Violation Name: Corridor - Doors(K-0363)

• Inspection Date: 2019-05-23 (Event ID: QGY321)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

Violation Name: PHARMACY ADMINISTRATION(A-0491)

• Inspection Date: 2019-05-23 (Event ID: QGY311)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

Violation Name: DELIVERY OF DRUGS(A-0500)

• Inspection Date: 2019-05-23 (Event ID: QGY311)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

Violation Name: MONITORING RADIATION EXPOSURE(A-0538)

• Inspection Date: 2019-05-23 (Event ID: QGY311)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

Violation Name: FOOD AND DIETETIC SERVICES(A-0618)

• Inspection Date: 2019-05-23 (Event ID: QGY311)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

Violation Name: ORGANIZATION(A-0619)

• Inspection Date: 2019-05-23 (Event ID: QGY311)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

Violation Name: DIRECTOR OF DIETARY SERVICES(A-0620)

• Inspection Date: 2019-05-23 (Event ID: QGY311)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

Violation Name: COMPETENT DIETARY STAFF(A-0622)

• Inspection Date: 2019-05-23 (Event ID: QGY311)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

Violation Name: THERAPEUTIC DIET MANUAL(A-0631)

• Inspection Date: 2019-05-23 (Event ID: QGY311)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

Violation Name: MAINTENANCE OF PHYSICAL PLANT(A-0701)

• Inspection Date: 2019-05-23 (Event ID: QGY311)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

Violation Name: Fire Drills(K-0712)

• Inspection Date: 2019-05-23 (Event ID: QGY321)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

Violation Name: VENTILATION, LIGHT, TEMPERATURE CONTROLS(A-0726)

• Inspection Date: 2019-05-23 (Event ID: QGY311)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

Violation Name: INFECTION PREVENTION CONTROL ABX STEWARDSHIP(A-0747)

• Inspection Date: 2019-05-23 (Event ID: QGY311)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

Violation Name: INFECTION CONTROL PROGRAM(A-0749)

• Inspection Date: 2019-05-23 (Event ID: QGY311)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

Violation Name: Gas and Vacuum Piped Systems - Inspection and(K-0908)

• Inspection Date: 2019-05-23 (Event ID: QGY321)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

Violation Name: Electrical Systems - Essential Electric Syste(K-0918)

• Inspection Date: 2019-05-23 (Event ID: QGY321)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

Violation Name: Electrical Equipment - Power Cords and Extens(K-0920)

• Inspection Date: 2019-05-23 (Event ID: QGY321)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

Violation Name: Gas Equipment - Cylinder and Container Storag(K-0923). This finding was confirmed by ES1. 2. At 11:19 a.m., on the 2nd floor, there was a full oxygen cylinder that was on the floor and unsecured. The cylinder was not properly chained or supported in a proper cylinder stand or cart. The cylinder was observed in the Post-Anesthesia Care Unit across from the nurse station. This finding was confirmed by ES1. 40597 B Tower - Main Hospital, 5/21/19: 3. At 2:25 p.m., there was an oxygen E type cylinder stored under an empty patient bed in the corridor of the fourth floor between the B Tower and Social Services office. The cylinder was laying flat on the plastic frame approximately 2 feet under the mattress. During a concurrent interview, the PO1 and CO1 confirmed the finding and PO1 stated the cylinder was possibly placed there by a staff.

Violation Name: OPERATING ROOM POLICIES(A-0951)

• Inspection Date: 2019-05-23 (Event ID: QGY311)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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22764 Based on observation, interview, and record review, the facility failed to ensure surgical services were performed in accordance with acceptable standards of practice in the outpatient surgery center when all instruments opened during procedures were not disinfected prior to being used in another procedure. This failure placed all patients having surgical procedures in the outpatient surgery center at an increased risk for infection. Findings: 1. During an interview with the Manager of Infection Prevention (MIP) on May 23, 2019, at 8:30 a.m., the MIP stated the facility followed Association of periOperative Registered Nurses (AORN) guidelines in the surgery departments. A tour of the outpatient surgical center was conducted on May 22, 2019, at 10 a.m., with the Sterile Processing Department Manager (SPDM). During a concurrent interview, the SPDM stated when a surgical case was completed, the surgical technician who assisted with the procedure would separate used instruments from unused instruments, and transport them to the SPD for reprocessing. The SPDM stated he would soak the used instruments in an enzymatic detergent, clean them with a brush, then rinse them, place them on top of the unused instruments in the instrument tray, and put the tray into the washer. The SPDM stated he did not clean the unused instruments. 2. During a tour of the outpatient surgical center on May 23, 2019, at 9:25 a.m., accompanied by the Director of Perioperative Services (DPS), the SPDM was observed reprocessing a tray of surgical instruments. The instruments were observed on the back table in operating room number one. The SPDM stated the used surgical instruments were sprayed at the end of the case to keep them moist, and the unused instruments were not sprayed. The SPDM was observed placing the used instruments in a plastic tub, covering them, and placing them on a cart. The unused instruments were placed on the same cart in the surgical instrument tray they were originally stored in. The cart was covered and taken to the SPD area for the instruments to be reprocessed. The SPD room had a two compartment sink. Each sink had a round basin sitting inside of it. The SPDM filled each basin with water, placed enzymatic detergent in the basin on the left hand side, and put the used instruments in the enzymatic detergent. The unused instruments were placed on the counter next to the sink, in the instrument tray they were originally stored in. The SPDM cleaned the used instruments, one at a time, with a brush. The SPDM dipped the instruments into the basin of water on the right hand side of the sink, then placed them on top of the unused instruments located in the instrument tray. The SPDM placed the instrument tray into the washer, where he stated they would wait to be washed until there were more trays. During an interview with the Director of Perioperative Services (DPS) on May 23, 2019, at 9:50 a.m., the DPS stated the SPDM should have washed all of the instruments that were opened during the surgical procedure, whether they had been used or not. According to the AORN, Guideline for Cleaning and Care of Surgical Instruments; Recommendation III.c: All instruments opened onto the sterile field in the operating room or procedure room should be cleaned and decontaminated whether or not they have been used. Scrubbed persons may touch and contaminate instruments without being aware of it. Instruments that were used may come into contact with unused items. Airborne microorganisms may come in contact with instruments that have not been used. Contamination of unused instruments on the sterile field can occur without the occurrence being noticed.

Violation Name: RECORDS OF RADIO PHARMACEUTICALS(A-1054)

• Inspection Date: 2019-05-23 (Event ID: QGY311)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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28294 Based on observation, interview, and record review, the facility failed to ensure an accounting was maintained of the wasted and unneeded radiopharmaceutical (radioactive compounds used for diagnostic or therapeutic purposes) products. This failed practice resulted in incomplete documentation for the tracking of radiopharmaceuticals. [Definitions: - Radionuclide - an atom that has excess nuclear energy, making it unstable. - TC99M MAA - macroaggregated albumin - one of the technetium radiopharmaceuticals used in lung perfusion imaging. - TC99M Sodium Pertechnetate - radioactive diagnostic agent used for the diagnosis of diseases in many tissues, particularly in the gastrointestinal system, cardiovascular and cerebral circulation, brain, thyroid, and joints. - TL201 Thallium - radiopharmaceutical for intravenous administration. - TC99M Cardiolite - radiopharmaceutical used for detecting coronary artery disease] Findings: On May 21, 2019, at 9:20 a.m., a tour of the Nuclear Medicine Department was conducted with the Supervisor of Nuclear Medicine (SNM). Radiopharmaceuticals were observed in the room designated as the, Hot Lab. In a concurrent interview, the SNM stated they were to be used for patients, and the containers would be returned to the vendor. Each special case/bag for returns contained up to eight containers of radiopharmaceuticals. The facility, Inventory Utilization Report, for May 20, 2019, dated May 21, 2019, indicated the facility received and used the following: - Received 6 and used 5 unit doses of TC99M Cardiolite, - Received 2 and used 0 unit doses of TC99M MAA, - Received 2 and used 0 bulk of TC99M Sodium Pertechnetate; and, - Received 5 and used 4 doses of TL201 Thallium. There was no documented indication as to what occurred with the unused/unneeded doses/bulk. The facility, Inventory Disposition Report, for May 20, 2019, dated May 21, 2019, indicated, by patient, the following: - radiopharmaceutical used; -the amount used; and, - the amount wasted. For some patients, the amount of radiopharmaceutical used was more than the original quantity received, and the amount wasted was then a negative number. The records did not accurately reflect the waste, and what occurred with the unused doses/bulk of radiopharmaceuticals. During a concurrent interview with the SNM, she stated the facility received three deliveries of radiopharmaceuticals each day, at 7 a.m., 9:30 a.m., and 12 p.m. The SNM stated the unneeded/unused doses were returned to the vendor, but there was no tracking mechanism for this process. The SNM stated once the return special case/bag had eight containers, the bag was closed, and the vendor would pick up the special case/bag during one of the deliveries. The SNM stated there was no tracking mechanism for what was in the containers being returned to the vendor. The SNM stated the facility's electronic documentation system for the radiopharmaceuticals had a, waste bin, which showed what was returned, but that function had not been working for sometime. The SNM stated the computer program was an older version, and the vendor was unable to get the, waste bin, function to work. The SNM stated radiopharmaceutical waste should be tracked.

Violation Name: Building Construction Type and Height(K-0161)

• Inspection Date: 2019-05-23 (Event ID: QGY321)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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31201 Based on observation and interview, the facility failed to maintain the integrity of the building construction. This was evidenced by unsealed penetrations in the ceiling and wall. This affected one of six floors in C Tower at the Main Hospital and the De Anza Surgery Center. This could result in the expedited spread of smoke or fire to other areas of the facility. Findings: During a tour of the facility and interview with the Hospital Staff on 5/23/19, the ceiling and wall was observed. C Tower - Main Hospital, 5/23/19: 1. At 9:47, on the 2nd floor, there was an approximately 3 inch by 3 inch penetration observed in the ceiling located in the Janitor's closet, Room C224.1. When interviewed, the ES1 and MM3 confirmed the finding and stated that the junction box cover in the ceiling was missing. De Anza Surgery Center, 5/23/19: 2. At 11:32 a.m., there was an approximately 2 inch by 3 inch penetration in the wall between the Fire Alarm Control Panel room and the Mechanical room. When interviewed, the ES3 and MM3 confirmed the finding.

Violation Name: PATIENT RIGHTS: RESTRAINT OR SECLUSION(A-0171)

• Inspection Date: 2019-05-23 (Event ID: QGY311)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** 28294 Based on observation, interview, and record review, the facility failed to ensure, for two of three sampled patients placed in restraints for the management of violent or self-destructive behavior (Patients 8 and 11): 1. Physicians and staff were able to properly identify the type of restraints being used when the orders were for, Non-violent, restraints; and, 2. The restraints were limited to four hours per episode, and renewed if the need for restraint continued. This failed practice resulted in the potential for unnecessary and unsafe use of restraints in violation of the patients' rights. Findings: 1 a. On [DATE], the record for Patient 8 was reviewed. Patient 8, a [AGE] year old female, presented to the facility Emergency Department (ED), on [DATE], at 1:58 a.m., with diagnoses including altered level of consciousness and apneic breathing (periods of not breathing). The Patient Notes dated [DATE], at 2:19 a.m., indicated Patient 8 got out of bed, ripped out her intravenous (IV - directly into a vein) line, ran into the ED hallway naked, and, started charging towards staff members. A physician's order dated [DATE], at 3:06 a.m., indicated, non-violent, restraints were to be applied on all four extremities. The Restraint Documentation dated [DATE], at 3:30 a.m., indicated restraints were initiated, and the clinical justification was combative, physical aggression, violent. The Patient Notes dated [DATE], at 3:40 a.m., indicated Patient 8 had aggressive behavior. During an interview with the Quality Manager (QM), on [DATE], at 10 a.m., she reviewed the record for Patient 8, and was unable to find documentation of a restraint order for violent/self-destructive behavior. The QM stated the orders for restraints should have been written based on the patient's actions/behaviors. b. During a tour of the Medical Surgical (MS) unit on [DATE], at 1:53 p.m., accompanied by Registered Nurse (RN) 1, Patient 11 was observed sitting in an upright position in her bed. The head of the bed was not elevated to support her back. Both wrists were restrained to the bed. She did not have any intravenous lines, cables, or tubing attached to her. In a concurrent interview, RN 1 stated Patient 11 was restrained due to restlessness and removing items from her bedside table. RN 1 stated, out of the blue, she just throws things. The record for Patient 11 was reviewed on [DATE]. Patient 11, a [AGE] year old female, was admitted on [DATE], with diagnoses that included high blood pressure and altered mental status. The patient was free of any intravenous lines and tubing as of [DATE]. The record indicated the following: - Patient 11 was removed from restraints following the tour and interview with RN 1 (on [DATE], at 6:07 p.m.); - At 9:39 p.m., she became combative, confused, not following commands, agitated, throwing objects, and trying to push the sitter. An order was obtained for, Non-violent, restraints; and, - At 9:40 p.m., Patient 11 was placed back in bilateral wrist restraints. The level of the restraints was documented as, non-violent. During an interview with the Director of the MS unit (DMS) on [DATE], at 1:45 p.m., the DMS stated the restraints were applied for violent behavior, and the order should have reflected that. 2 a. On [DATE], the record for Patient 8 was reviewed. Patient 8, a [AGE] year old female, presented to the facility Emergency Department (ED), on [DATE], at 1:58 a.m., with diagnoses including altered level of consciousness and apneic breathing (periods of not breathing). The Patient Notes dated [DATE], at 2:19 a.m., indicated Patient 8 got out of bed, ripped out her intravenous (IV - directly into a vein) line, ran into the ED hallway naked, and, started charging towards staff members. A physician's order dated [DATE], at 8:53 a.m., indicated bilateral soft upper extremity restraints were to be applied for attempts of self-harm, combative, physical aggression, and unsafe mobile attempts; the level of restraint was violent/self-destructive; and the order expired in four [4] hours. The Patient Notes dated [DATE], indicated the following: - At 9 a.m., Patient 8 was running down the hallway, and the patient was trying to kick the staff as they were trying to put the patient back to bed. Patient 8 was given Haldol (medication used to treat mental/mood disorders), and was placed in bilateral upper extremity restraints; - At 10:30 a.m., Patient 8 was biting off her right upper arm restraint, was kicking whoever came close to her, and a code gray (combative person) was called; and, - At 3:26 p.m. (six hours and 33 minutes after the restraints were applied), Patient 8 remained in restraints. There was no evidence the order to place Patient 8 in restraints for violent/self-destructive behavior were renewed after four hours ([DATE], at 12:53 p.m.), even though the restraints remained in place. During an interview with the Quality Manager (QM), on [DATE], at 10 a.m., she reviewed the record for Patient 8, and was unable to find documentation of a restraint order for violent/self-destructive behavior after [DATE], at 12:53 p.m., even though the restraints remained on the patient. The QM stated the restraint order should have been renewed every four hours. b. During a tour of the Medical Surgical (MS) unit on [DATE], at 1:53 p.m., accompanied by Registered Nurse (RN) 1, Patient 11 was observed sitting in an upright position in her bed. The head of the bed was not elevated to support her back. Both wrists were restrained to the bed. She did not have any intravenous lines, cables, or tubing attached to her. In a concurrent interview, RN 1 stated Patient 11 was restrained due to restlessness and removing items from her bedside table. RN 1 stated, out of the blue, she just throws things. The record for Patient 11 was reviewed on [DATE]. Patient 11, a [AGE] year old female, was admitted on [DATE], with diagnoses that included high blood pressure and altered mental status. The patient was free of any intravenous lines and tubing as of [DATE]. The record indicated the following: - Patient 11 was removed from restraints following the tour and interview with RN 1 (on [DATE], at 6:07 p.m.); - At 9:39 p.m., she became combative, confused, not following commands, agitated, throwing objects, and trying to push the sitter, and an order was obtained for restraints; - At 9:40 p.m., Patient 11 was placed back in bilateral wrist restraints; and, - Patient 11 remained in restraints for 17 ,d+[DATE] hours. There was no evidence the restraint order was renewed after four hours of restraint use (for the management of Patient 11's behavior). During an interview with the Director of the MS unit (DMS) on [DATE], at 1:45 p.m., the DMS stated the restraints were applied for violent behavior, and the order should have been renewed every four hours. The facility policy and procedure titled, Restraint and Seclusion Guidance Policy, last revised by the facility February 2018, revealed . Order for Restraint with Violent or Self-Destructive Behavior .Orders for restraint or seclusion must not exceed: Four (4) hours for adults, aged [AGE] years and older .To continue restraint or seclusion beyond the initial order duration, the RN determines that the patient is not ready for release and calls the ordering physician to obtain a renewal order. Renewal orders for restraint/seclusion may not exceed: Four (4) hours for adults, aged [AGE] years or older

Violation Name: GOVERNING BODY(A-0043)

• Inspection Date: 2019-04-11 (Event ID: TGS511)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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22764 Based on interview and record review, the governing body failed to ensure: 1. Maintenance an effective Quality Assessment and Performance Improvement (QAPI) program that led to improvement in the care of patients in the Emergency Department (ED) (Refer to A263); 2. Data collected by administration was used to monitor the safety and effectiveness of services in the emergency department (ED), when management reports indicated patient wait times were excessive (Refer to A273); 3. Data collected by the administration was used to identify areas for improvement in the ED, a high risk, high volume, problem prone area (Refer to A283); 4. ED QAPI efforts were aimed at improving quality of care and patient safety, when the governing body was aware of, and they did not respond to, staff concerns regarding quality of care in the ED (Refer to A309); 5. Emergency services were provided in a safe and effective manner (Refer to A1100); 6. Patients with orders to be admitted to the intensive care unit, the progressive care unit, telemetry units, and medical surgical units were provided inpatient beds before accepting elective interfacility transfers from other hospitals (Refer to A1103); 7. Patients in the ED with orders to be admitted to telemetry were provided the same level of service/monitoring as patients on the telemetry units (Refer to A1103); 8. Emergency care for patients arriving by ambulance was started in a timely manner (Refer to A1103); and, 9. Adequate staffing was provided to meet the needs of the patients in the ED (Refer to A1112). The cumulative effect of these systemic problems resulted in failure to ensure the governing body accepted responsibility for safe and effective operations at the hospital.

Violation Name: PATIENT RIGHTS: RESTRAINT OR SECLUSION(A-0166)

• Inspection Date: 2019-04-11 (Event ID: TGS511)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** 22764 Based on interview and record review, the facility failed to ensure one of eight patients in restraints (Patient 57) had a written modification to their care plan completed when restraints were applied. This failed practice resulted in the potential for staff to be unaware of restraint use interventions needed to prevent harm to the patient. Findings: On April 8, 2019, the medical record for Patient 57 was reviewed. The record indicated Patient 57 was admitted on [DATE], for atypical measles syndrome (AMS), combativeness, and self harm. A review of the record indicated Patient 57 had a history of myelodysplastic syndrome (a group of disorders caused when something disrupts the production of blood cells), Parkinson disease (a disorder of the central nervous system affecting movement), and pancytopenia (condition which there is decreased red blood cells, white blood cells, and platelets). The record indicated on April 5, 2019, Patient 57 was placed in bilateral soft wrist restraints (soft padded cloth material). The record indicated there were no interventions in the care plan for the use of restraints. On April 8, 2019, at 3:30 p.m., during an interview with the telemetry registered nurse (TRN) 4, she stated when a care plan was started or updated, there should be a minimum of three interventions put in the care plan. TRN 4 stated there should have been interventions for restraint use documented in Patient 57's care plan. On April 8, 2019, at 3:50 p.m., during an interview with the director of telemetry, she stated there should have been interventions entered in the care plan when soft wrist restraints were placed on Patient 57. On April 8, 2019, the facility policy and procedure titled, Restraint and Seclusion Guidance Policy dated March 2018, was reviewed. The policy indicated: .To Provide guidelines for use of least restrictive interventions to avoid restraint or seclusion use . .Care of the Patient/Plan of Care . .The plan of care will clearly reflect a loop of assessment, interventions, and evaluation for restraint, seclusion and medications . 36239 37659

Violation Name: PATIENT RIGHTS: RESTRAINT OR SECLUSION(A-0173)

• Inspection Date: 2019-04-11 (Event ID: TGS511)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** 28294 Based on interview and record review, the facility failed to ensure an order for the continued use of restraints was obtained for two of eight patients in restraints (Patients 72 and 86). This resulted in restraints being applied without a physician's order, and restraints being continued after the physician's order had expired. This had the potential to result in unnecessary restraint use. Findings: a. On [DATE], the record for Patient 72 was reviewed. Patient 72 was admitted to the facility on [DATE], with diagnoses including delirium tremens (DTs - rapid onset of confusion usually caused by withdrawal from alcohol) and gastrointestinal bleeding. On [DATE], at 6:26 a.m., a physician's order for non-violent, soft bilateral upper extremity restraints was written, and soft bilateral wrist restraints were applied at 7 a.m. The, Patient Assessment(s), from [DATE], at 7 a.m., through [DATE], at 8 a.m., indicated Patient 72 had restraints on continuously (except for six minutes on [DATE], and one hour on [DATE]). Additional orders for restraints were written as follows: - On [DATE], at 1:32 a.m., soft bilateral upper extremity; - On [DATE], at 7:58 a.m., soft bilateral upper extremity; - On [DATE], at 5:58 p.m., soft bilateral all extremities (upper and lower extremities); - On [DATE], at 2:35 a.m., soft bilateral upper extremity; and - On [DATE], at 10:59 a.m., soft bilateral upper extremity. There were no orders for restraints between [DATE], at 5:58 p.m., and [DATE], at 2:35 a.m. (greater than 56 hours between restraint order,s or two calendar days), even though the restraint assessment indicated soft bilateral all extremity restraints were on Patient 72 on [DATE] and 7, 2019. During an interview with Registered Nurse (RN) 10, on [DATE], at 2:30 p.m., she reviewed the record for Patient 72, and was unable to find documentation of restraint orders between [DATE], at 5:58 p.m., and [DATE], at 2:35 a.m. RN 10 stated the order for restraints should be obtained daily, and restraints should not be continued without a current physician's order. The facility policy and procedure titled Restraint and Seclusion Guidance Policy last revised by the facility February 2018, revealed . Order for Restraint with Non-Violent or Non-Self-Destructive Behavior - Duration of order for restraint must not exceed 24 hours for the initial order and must specify clinical justification for the restraint, the date and time ordered, the duration of use, the type of restraint and behavior-based criteria for release. . If reassessment indicates an ongoing need for restraint, a new order must be written each calendar day by the LIP/physician. . b. On [DATE], the record for Patient 86 was reviewed. Patient 86 was admitted to the facility on [DATE], with diagnoses including intracerebral hemorrhage (bleeding within the brain). A physician's order on [DATE], at 2:35 a.m., indicated soft bilateral upper extremity restraints were to be applied for violent/self-destructive behavior, and the order expired on [DATE], at 6:35 a.m. (violent restraints time limited to four hours). The Patient Assessment for restraints indicated bilateral upper extremity mittens were applied on [DATE], at 1:45 a.m., and continued after [DATE], at 6:35 a.m. The next physician's order for restraints was on [DATE], at 9:29 a.m. (2 hours and 54 minutes after the previous order for restraints had expired). On [DATE], at 6:35 a.m., the bilateral upper extremity mittens remained on Patient 86 without a current physician's order. During an interview with the Quality Manager (QM), on [DATE], at 2:30 p.m., she reviewed the record for Patient 86, and was unable to find documentation of an order for restraints between [DATE], at 6:35 a.m., and [DATE], at 9:29 a.m. The QM stated a new order for restraints should have been obtained on [DATE], at 6:35 a.m., when the previous order expired. The QM stated restraints should not be applied or remain on the patient without a current physician's order. The facility policy and procedure titled Restraint and Seclusion Guidance Policy last revised by the facility February 2018, revealed . Order for Restraint with Violent or Self-Destructive Behavior - Physician orders for restraint or seclusion must be time limited and must specify clinical justification for the restraint or seclusion, the date and time ordered, duration of restraint or seclusion use, the type of restraint, and behavior-based criteria for release. Orders for restraint or seclusion must not exceed: Four (4) hours for adults . To continue restraint or seclusion beyond the initial order duration, the RN determines that the patient is not ready for release and calls the ordering physician to obtain a renewal order. .

Violation Name: PATIENT RIGHTS: RESTRAINT OR SECLUSION(A-0175)

• Inspection Date: 2019-04-11 (Event ID: TGS511)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** 28294 Based on interview and record review, the facility failed to ensure reassessments were completed and documented per facility policy and procedure for one of eight patients in restraints (Patient 85). This had the potential to result in possible injuries related to the use of restraints to go unrecognized. Findings: On April 10, 2019, the record for Patient 85 was reviewed. Patient 85 was admitted to the facility on [DATE], with diagnoses including trauma due to motor vehicle accident, rib fractures, and pneumothorax (a collapsed lung). There were physician orders for non-violent, soft bilateral upper extremity restraints for April 7, 2019, at 6:19 a.m.; April 8, 2019, at 9:40 a.m.; April 9, 2019, at 7:47 p.m., and April 10, 2019, at 12:11 a.m. The Patient Assessment for restraints indicated the soft bilateral upper extremity restraints were initially applied on April 7, 2019, at 6:20 a.m. The Patient Assessment(s) for restraint monitoring was completed on April 9, 2019, at 7:50 p.m., and on April 10, 2019, at 8 a.m. There was no documented indication restraint monitoring had been done and documented between April 9, 2019, at 7:50 p.m., and April 10, 2019, at 8 a.m. (12 hours). During an interview with the Quality Manager (QM), on April 10, 2019, at 2 p.m., she reviewed the record for Patient 85, and was unable to find restraint monitoring documented between April 9, 2019, at 7:50 p.m., and April 10, 2019, at 8 a.m. The QM stated restraint monitoring should have been done and documented on April 9, 2019, at 10 p.m., and April 10, 2019, at 12 a.m., 2 a.m., 4 a.m., and 6 a.m., every two hours. The facility policy and procedure titled Restraint and Seclusion Guidance Policy last revised by the facility February 2018, revealed . An RN will assess the patient at least every two (2) hours. The assessment will include where appropriate: Signs of injury associated with restraint, including circulation of affected extremities; Respiratory and cardiac status; Psychological status, including level of distress or agitation, mental status and cognitive functioning; Needs for range of motion, exercise of limbs and systematic release of restrained limbs are being met; Hydration/nutritional needs are being met; Hygiene, toileting/elimination needs are being met; The patient's rights, dignity, and safety are maintained; Patient's understanding of reasons for restraint and criteria for release from restraint; and Consideration of less restrictive alternatives to restraint. .

Violation Name: PATIENT RIGHTS: RESTRAINT OR SECLUSION(A-0178)

• Inspection Date: 2019-04-11 (Event ID: TGS511)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** 28294 Based on interview and record review, the facility failed to ensure one of one patients placed in restraints for violent or self-destructive behavior (Patient 86) was seen face-to-face by a physician or a trained Registered Nurse (RN) within one hour after the initiation of the restraint. This failed practice resulted in the patient not being evaluated in order to determine if a serious medical or psychological condition existed, and/or to determine if the continued use of restraints was necessary. Findings: On [DATE], the record for Patient 86 was reviewed. Patient 86 was admitted to the facility on [DATE], with diagnoses including intracerebral hemorrhage (bleeding within the brain). A physician's order on [DATE], at 2:35 a.m., indicated soft bilateral upper extremity restraints were to be applied for violent/self-destructive behavior, and the order expired on [DATE], at 6:35 a.m. (violent restraint time limited to four hours). The Patient Assessment(s) for restraints indicated bilateral upper extremity mittens were applied on [DATE], at 1:45 a.m., and continued after [DATE], at 6:35 a.m. There was no documented indication a one hour, face-to-face assessment was done by the physician, Licensed Independent Practitioner, trained RN or trained physician assistant, after the initial application of restraints for violent/self-destructive behavior. During an interview with the Quality Manager (QM), on [DATE], at 2:30 p.m., she reviewed the record for Patient 86, and was unable to find documentation of the one hour, face-to-face assessment of the patient after restraints had been ordered for violent/self-destructive behavior. The QM stated based on the physician's order, the one hour, face-to-face assessment should have been done by a qualified individual. During an interview with the Director Education (DE), on [DATE], at 8:35 a.m., she stated the RNs do not have the training to do the one hour, face-to-face assessment for patients with violent/self-destructive restraints. The DE stated the one hour, face-to-face assessment was done by a physician or a trained allied health professional. The facility policy and procedure titled Restraint and Seclusion Guidance Policy last revised by the facility February 2018, revealed . A face-to-face assessment by a physician or LIP (Licensed Independent Practitioner), RN or physician assistant (PA) with demonstrated competence, must be done within one (1) hour of restraint or seclusion initiation or administration of medication to manage violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others. At the time of the face-to-face assessment, the LIP/physician/RN/PA will: Work with staff and patient to identify ways to help the patient regain control; Evaluate the patient's immediate situation; Evaluate the patient's reaction to the intervention; Evaluate the patient's medical and behavioral condition; Evaluate the need to continue or terminate the restraint or seclusion; Revise the plan of care, treatment and services as needed. Note: A telephone call or telemedicine methodology does not constitute face-to-face assessment. .

Violation Name: DATA COLLECTION & ANALYSIS(A-0273)

• Inspection Date: 2019-04-11 (Event ID: TGS511)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** 22764 Based on interview and record review, the facility failed to use data collected by administration to monitor the safety and effectiveness of services in the emergency department (ED), when management reports indicated patient wait times were excessive. This failed practice resulted in ongoing delays in patient care and the potential for harm or death. Findings: Observations, interviews, and record reviews conducted during the survey revealed delays in care, lack of monitoring, and inadequate staff to meet the needs of the patients in the emergency department (Refer to A1103 and A1112). During a Quality Assessment and Performance Improvement (QAPI) interview on April 11, 2019, at 11:40 a.m., the ED Management Operation Report ([NAME]) was presented by the Chief Nursing Officer (CNO). The report indicated for the months of January and February 2019, the following data was available to administration: a. The average ED patient arrival to discharge time was 295 minutes (five hours), with a target of 125 minutes (two hours); b. The average length of stay (LOS) in the ED for an admitted patient was 899.5 minutes (15 hours), with a target of 210 minutes (three and one half hours); c. The average amount of time for an admitted patient to transfer to an inpatient bed was 659 minutes (11) hours, with a target of 60 minutes (one hour); and, d. The average number of admitted patients held in the ED waiting for a bed was 88.5%, with a target of 35%. The CNO stated the data was collected by the corporate office and was discussed by administration. A review of the QAPI meeting minutes indicated no data related to ED patient throughput time was being reported. In a concurrent interview with the [NAME] President of Quality and Patient Safety, she stated she knew the report was available for administration to view, but she had never seen the report and there was no QAPI project in place to analyze the data and plan improvements. 37659

Violation Name: QUALITY IMPROVEMENT ACTIVITIES(A-0283)

• Inspection Date: 2019-04-11 (Event ID: TGS511)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** 22384 Based on interview and record review, the facility's Quality Assessment and Performance Improvement (QAPI) Program failed to use data collected by the administration to identify areas for improvement in the Emergency Department (ED), a high risk, high volume, problem prone area. This failure had the potential to impact the overall quality of care for all patients in the ED. Findings: Observations, interviews, and record reviews conducted during the survey revealed multiple quality of care issues in the ED. Issues included delays in the transfer of patient care from ambulance care to the nursing and medical staff, accepting interfacility transfers when multiple patients were admitted but awaiting inpatient placement (Refer to A1103), in addition to inadequate staffing to meet the needs of the patients (Refer to 1112). During the QAPI interview on April 11, 2019, at 11:40 a.m., the ED Management Operation Report ([NAME]) was presented by the Chief Nursing Officer (CNO). The report indicated for the months of January and February 2019, the following data was available to administration: a. The average ED patient arrival to discharge time was 295 minutes (five hours), with a target of 125 minutes (two hours); b. The average length of stay (LOS) in the ED for an admitted patient was 899.5 minutes (15 hours), with a target of 210 minutes (three and one half hours); c. The average amount of time for an admitted patient to transfer to an inpatient bed was 659 minutes (11) hours, with a target of 60 minutes (one hour); and, d. The average number of admitted patients held in the ED waiting for a bed was 88.5%, with a target of 35%. The CNO stated the data was collected by the corporate office and was discussed by administration. A review of the QAPI meeting minutes indicated no data related to ED patient throughput time was being reported. In a concurrent interview with the [NAME] President of Quality and Patient Safety, she stated the Quality Department was not involved with the ED data, and was not looking at, or analyzing, trends impacting the ED at that time.

Violation Name: QAPI EXECUTIVE RESPONSIBILITIES(A-0309)

• Inspection Date: 2019-04-11 (Event ID: TGS511)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** 22764 Based on interview and record review, the Governing Body failed to ensure emergency department Quality Assessment Performance Improvement (QAPI) efforts were aimed at improving quality of care and patient safety, when they were aware of and they did not respond to staff concerns regarding quality of care in the emergency department. This failed practice resulted in the potential to adversely impact the provision of care for patients in the ED leading to harm or death. Findings: Observations, interviews, and record reviews conducted during the survey revealed delays in care, lack of monitoring, and inadequate staff to meet the needs of the patients in the emergency department (Refer to A1103 and A1112). The facility Performance Improvement Plan was reviewed on April 17, 2019. The plan indicated the following: a. Leadership was defined as the members of the Governing Board, Hospital Management, and elected leaders of the Medical Staff, who had authority and responsibility to implement and maintain programs for performance improvement; b. Leadership set the priorities for organization wide performance improvement, which included staffing effectiveness and patient outcomes; c. Leadership provided the highest priority to high volume, high risk, and problem prone areas; and, d. Prioritization was directed to areas that affected health outcomes and quality of care. The Bylaws Governing The Board of Trustees were reviewed, July 25, 2018. The Bylaws indicated the Board was ultimately responsible for the quality of patient care and services provided by the Hospital. A review of the Governing Board meeting minutes dated February 27, 2019, was conducted. The Chief Executive Officer (CEO) discussed staff complaints regarding the facility taking transfers when there were no staff to care for them. The CEO, reassured the board members that we are working to cleanup language and the messaging throughout the facility. There was no evidence of discussion regarding actions planned, or taken, to address the concerns and evaluate the quality of care. During an interview with the Governing Body on April 11, 2019, at 10:05 a.m., the members indicated they were acutely aware of the struggles in the ED. During a Quality Assessment and Performance Improvement (QAPI) interview on April 11, 2019, at 11:40 a.m., the ED Management Operation Report ([NAME]) was presented by the Chief Nursing Officer (CNO). The report indicated for the months of January and February 2019, the following data was available to administration: a. The average ED patient arrival to discharge time was 295 minutes (five hours), with a target of 125 minutes (two hours); b. The average length of stay (LOS) in the ED for an admitted patient was 899.5 minutes (15 hours), with a target of 210 minutes (three and one half hours); c. The average amount of time for an admitted patient to transfer to an inpatient bed was 659 minutes (11) hours, with a target of 60 minutes (one hour); and, d. The average number of admitted patients held in the ED waiting for a bed was 88.5%, with a target of 35%. The CNO stated the data was collected by the corporate office and was discussed by administration. A review of the QAPI meeting minutes indicated no data related to ED patient throughput time was being reported. In a concurrent interview with the [NAME] President of Quality and Patient Safety, she stated she knew the report was available for administration to view, but she had never seen the report and there was no QAPI project in place to analyze the data and plan improvements. 37659

Violation Name: ADMINISTRATION OF DRUGS(A-0405)

• Inspection Date: 2019-04-11 (Event ID: TGS511)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** 22764 Based on observation, interview, and record review, the facility failed to ensure a medication was administered as ordered for one patient receiving a Cardizem drip (Patient 43), when the drip was not titrated (increased or decreased) in accordance with the physician's orders. This failure resulted in the potential for the patient's heart rate to become dangerously fast or slow resulting in potential for harm or death for the patient. [A Cardizem drip is a medication administered through a continuous IV infusion (intravenous - directly into the vein) that acts to control the heart rate] Findings: On April 8, 2019, at 10:38 a.m., Patient 43 was observed in bed asleep with an IV drip of Cardizem infusing in the right forearm. The record for Patient 43 was reviewed on April 9, 2019. Patient 43, a [AGE] year old female, was admitted to the facility on [DATE], with a diagnosis of rapid rate atrial fibrillation (a fast irregular heart rhythm). On April 7, 2019, the physician ordered a Cardizem IV drip to be started at 5 mg/hr (milligrams per hour), Titrate to a maximum rate of 15 mg/hr in increments of 5 mg every 15 minutes to maintain heart rate between 60 and 110 beats per minute, and/or hold for systolic blood pressure (top number in the blood pressure from the arteries during contraction of the heart) of less than 100. The record indicated the following: 1. On April 7, 2019 at 2:47 a.m., the nurse started the drip at 5 mg/hr with a heart rate of 149. No blood pressure (BP) was recorded; 2. At 3:02 a.m., the heart rate was 138 and the drip was increased to 10 mg/hr. No BP was recorded; 3. At 3:17 a.m., the heart rate was 145 and the drip rate was increased to 15 mg/hr. No BP was recorded; 4. At 4:17 a.m., the heart rate was 147 and the drip rate remained at 15 mg/hr. No BP was recorded; 5. At 5:17 a.m., the heart rate was 123 and the drip rate was decreased to 10 mg/hr. No BP was recorded; 6. At 6:15 a.m., the heart rate was 132 and the drip rate remained at 10 mg/hr. No BP was recorded; 7. At 7 a.m., the heart rate was 122 and drip rate remained at 10 mg/hr. No BP was recorded; 8. At 8:22 a.m., the heart rate was 135 and drip rate was increased to 15 mg/hr. No BP was recorded; 9. At 9:16 a.m., the heart rate was 100 and the drip rate was decreased to 10 mg/hr. No BP was recorded; 10. At 9:55 a.m., there was no recorded heart rate and the drip rate was decreased to 5 mg/hr. No BP was recorded; 11. At 2:16 p.m. (five hours and 11 minutes since the last recorded vital signs [VS]), there was no recorded heart rate and the drip rate was increased to 10 mg/hr. No BP was recorded; 12. At 5:56 p.m.(eleven hours and 23 minutes since the last VS), there was no recorded heart rate and the drip was increased to 15 mg/hr. No BP was recorded; 13. At 8 p.m., and 9 p.m. (fourteen hours and 19 minutes since the last recorded VS), there were no recorded heart rates and the drip remained at 15 mg/hr. No BP was recorded; 14. At 10 p.m. (sixteen hours and 19 minutes since last recorded VS), there was no recorded heart rate, no BP recorded and the drip was decreased to 12 mg/hr.; 15. At 11 p.m. (Seventeen hours and 19 minutes since last recorded VS), there was no recorded heart rate, no BP recorded and the drip remained at 12 mg/hr.; 16. On April 8, 2019, at 12 midnight (eighteen hours and 19 minutes after the last recorded VS), there was no recorded heart rate, no recorded BP and the drip was decreased to 10 mg/hr.; and, 17. At 8 a.m., the heart rate was 105 and the drip rate was decreased to 5 mg/hr. No BP was recorded. The facility policy titled, Titratable Intravenous Medication Infusion Orders-Adults, with a revised date of October 2018, was reviewed on April 9, 2019. The policy indicated for titration orders, the dose should be progressively increased or decreased in response to the patient's status to maintain (or remain within) the specifically ordered physiologic parameters. On April 11, 2019, at 11:05 a.m., Telemetry Registered Nurse (TRN) 5 was interviewed. TRN 5 stated VS should be recorded, and any changes in drip rates should be made, as ordered by the doctor. 37659

Violation Name: EMERGENCY SERVICES(A-1100)

• Inspection Date: 2019-04-11 (Event ID: TGS511)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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22764 Based on observation, interview, and record review, the facility failed to ensure: 1. Patients with orders to be admitted to the intensive care unit (ICU), the progressive care unit (PCU), telemetry units, and medical surgical units were provided inpatient beds before accepting elective interfacility transfers from other hospitals (Refer to A1103); 2. Patients in the Emergency Department (ED) with orders to be admitted to telemetry were provided the same level of service/monitoring as patients on the telemetry units (Refer to A1103); 3. Emergency care for patients arriving by ambulance was started in a timely manner (Refer to A1103); and, 4. Adequate staffing was provided to meet the needs of the patients in the ED (Refer to A1112). The cumulative effect of these systemic problems resulted in failure to ensure emergency services were provided in a safe and effective manner.

Violation Name: QUALIFIED EMERGENCY SERVICES PERSONNEL(A-1112)

• Inspection Date: 2019-04-11 (Event ID: TGS511)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** 22764 Based on observation, interview, and record review, the facility failed to ensure adequate staffing to meet the needs of the patients in the Emergency Department (ED), when: 1. Two nurses were each assigned 11 patients, who were identified as having urgent or emergent needs, on the morning of April 8, 2019; 2. One nurse was assigned 18 patients, who were identified as having urgent or emergent needs, on the night of April 8, 2019; 3. Three nurses were assigned to an area with seventeen patients, identified as having urgent or emergent needs, on the morning of April 9, 2019; and, 4. Two nurses were each assigned 11 patients, identified as having urgent or emergent needs, on the afternoon of April 9, 2019. This failed practice resulted in failure to provide adequate monitoring, assessments/reassessments, pain management, and treatment. Findings: [According to the Canadian Triage and Acuity Scale (the scale used by the ED); - Level 2 patients are, Emergent, patients with conditions that are a potential threat to life, limb, or function, requiring rapid medical intervention. These patients should be reassessed every 15 minutes; and, - Level 3 patients are, Urgent, with conditions that could potentially progress to a serious problem requiring emergency intervention. These patients should be reassessed every 30 minutes] 1. During a tour of the ED on April 8, 2019, at 10:20 a.m., accompanied by the [NAME] President of Quality and Patient Safety (VPQPS), the Associate Director of the ED (ADED), and the ED Clinical Manager (EDCM), the EDCM stated after patients were triaged, if there were no beds available, the patients were sent to one of two waiting areas to wait for care, depending on their level of acuity. The EDCM stated level 2 and 3 patients were sent to the chairs in the hallway, inside of the ED. During the tour, multiple patients were observed lined up in chairs against the wall, in the hallway inside the ED. During an interview with ED registered nurse (RN) A, on April 8, 2019, at 10:30 a.m., EDRN A stated there were 22 patients sitting along the wall in the hallway, and there were two nurses assigned to care for the 22 patients. EDRN A stated the, chairs, usually had one nurse assigned to care for the patients who were there waiting for treatment, a disposition, or a bed. EDRN A stated the nurses assigned to the, chairs, were responsible for treatments that were ordered, and discharged some patients from the area if they did not get into a bed before their treatment was completed. EDRN A stated five of the patients were currently receiving treatment as follows: - One patient (Patient 97) had chest pain with a high heart rate, had an IV started for a Computerized Axial Tomography (CAT) scan of his abdomen, and was receiving IV fluids. - One patient (Patient 99) was medicated for dizziness; - One patient (Patient 100) was receiving a breathing treatment due to shortness of breath; - One patient (Patient 101) was receiving intravenous (IV - directly into the vein) fluids, and had been medicated for abdominal pain and vomiting; and, - One patient (Patient 102) had been given an injection for pain. During the interview, EDRNA received a call from the laboratory with a panic value (Sodium level of 118 - normal 135-145) for one patient (Patient 103). The list of patients admitted to the chairs since the beginning of EDRN A's shift was reviewed. The list indicated the following patients had eloped from the ED (left without notice) since 7 a.m.: - One patient with chest pain who had been treated with aspirin (to dissolve a possible clot in the coronary artery) and nitroglycerine (to dilate the vessels and increase the blood flow and oxygenation to the heart); - One patient with chest pain and shortness of breath after cocaine ingestion; and, - One patient with chest pain, shortness of breath, and throat swelling. Records for five of the 22 patients were reviewed and indicated the following: a. Patient 97, a [AGE] year old male, presented to the ED on April 8, 2019, at 5:40 a.m. (after being admitted for alcohol withdrawals and leaving against medical advice the day prior), with complaints of chest pain. Patient 97 had a heart rate of 135 (normal 60-100), and was assigned an acuity level 2 (emergent) and placed in a chair in the hallway. The record indicated Patient 97 had an IV inserted and received one liter of IV fluids and an abdominal CAT scan. No further vital signs were checked. Patient 97 eloped from the ED at 11:47 a.m. (six hours and seven minutes after arriving), with an IV still in place. b. Patient 104, a [AGE] year old male, presented to the ED on April 8, 2019, at 8:41 a.m., with a history of liver disease and an acute change in his mental status and level of orientation. The record indicated Patient 104 was assigned an acuity level 2 (emergent) and placed in a chair in the hallway after his vital signs were taken at 8:50 a.m. Critical, laboratory results were called to the ED nurse at 10:40 a.m., with a sodium level of 118, while Patient 104 was waiting in the chair (low sodium levels potentially lead to brain swelling, confusion, and brain damage). The record indicated vital signs were not rechecked until 12:19 p.m. (three hours and 29 minutes after the initial vital signs were checked). c. Patient 36 presented to the ED on April 8, 2019, at 8:56 a.m., with a chief complaint of testicular pain and swelling. The patient was triaged at 9:06 a.m., and placed in a chair in the ED hallway at 9:55 a.m. The patient was assigned an acuity level 3 (urgent). Patient 36's vital signs were taken at the time he was triaged on April 8, 2019, at 8:56 a.m., and not again until 2:28 p.m.,upon discharge (five hours and 32 minutes later). An interview was conducted with the ED Clinical Manager on April 10, 2019, at 10:30 a.m., who stated the patient's vital signs were delayed. d. Patient 49, a [AGE] year old male, presented to the ED on April 8, 2019, at 9:16 a.m., with complaints of abdominal distension (swelling), shortness of breath for one week, a history renal (kidney) insufficiency, and hyperglycemia (high blood sugar). Patient 49 was triaged at 9:23 a.m., assigned an acuity level 2 (emergent) and placed in a chair. Vital signs showed a blood pressure of 160/122 (normal 120/80), and a heart rate of 101 (normal 60-100). At 2:21 p.m., Patient 49 had a paracentesis (drainage of a large volume of fluid from the abdomen) with 2500 ml (milliliters) removed. At 3:55 p.m. (six hours and 32 minutes after the first set of vital signs), the second (and final) blood pressure taken on Patient 49 was 153/100, and his heart rate was 98. e. Patient 50, a [AGE] year old female, presented to the ED at 7:20 a.m. on April 8, 2019, with complaints of dizziness, nausea, and headache. Triage vital signs at 7:27 a.m., showed a blood pressure of 144/90, a heart rate of 106, and a pain level of 7 (very intense) on a 1-10 scale. Patient 50 was assigned an acuity level 3 (urgent), and placed in a chair. At 8:53 a.m., Meclizine (a medication to treat motion sickness and dizziness) 25 mg (milligrams) was administered orally. No other vital signs were taken during the remainder of the ED stay. 2. During a tour of the ED on April 8, 2019, at 8:15 p.m., accompanied by the ED Clinical Supervisor (CS), multiple patients were observed lined up in chairs against the wall, in the hallway inside the ED. In a concurrent interview, EDRN B stated she was the only nurse assigned to the chairs, and she currently had 18 patients she was responsible for, one of those with orders to admit to the telemetry unit. EDRN B stated it was, very frustrating, when they could not get ED beds or inpatient beds for their own ED patients, because they were accepting interfacility transfers and holding them in the ED for hours. EDRN B stated it would be OK if all of the patients in the ED were actually ED patients, because they would all come in, get treated, then go on to their disposition. EDRN B stated they could manage the flow that way, and they wouldn't have all of those patients in chairs, but there was no flow when, this is happening. Records for four of the 18 patients were reviewed and indicated the following: a. Patient 74 presented to the ED, on April 8, 2019, at 6:13 p.m., with complaints of asthma, chronic obstructive pulmonary disease (COPD - progressive lung disease), and swelling in both lower legs. Patient 74 was triaged at 6:18 p.m., vital signs were obtained to include an oxygen saturation on room air of 92% (normal range 95 to 100%) and a heart rate of 115 (normal 60 to 100); pain level was a 6 on a scale of 1-10. Patient 74 was assigned an acuity level 2 (emergent). Patient 74 was placed in a chair in the ED hallway, oxygen via a nasal cannula was applied at 2 liters per minute, a saline lock intravenous line was started, and a breathing treatment was done by the respiratory therapist. On April 8, 2019, at 9:30 p.m., Methylprednisolone (a steroid) 125 mg IV (intravenous - directly into a vein) was ordered, and it was given at 10:42 a.m. (greater than one hour after being ordered). The next nursing assessment was done at 11:19 p.m. (5 hours after the triage assessment), and vital signs were done at 11:26 p.m. (five hours and eight minutes after the triage vital signs) The vital signs showed a heart rate of 111. At 11:48 p.m., Patient 74 was moved from the chairs in the ED hallway to a room in the ED, and was subsequently admitted to the facility. During an interview with the ED Operations Manager (EDOM), on April 9, 2019, at 12:45 p.m., she stated vital signs and a reassessment of the chief complaint should be done at least every two hours, and more frequently based on the patient's condition. b. Patient 75 presented to the ED on April 8, 2019, at 6:09 p.m., with complaints of chest pain, left arm pain, bilateral swelling of both lower legs, and high blood pressure. Patient 75 was triaged at 6:20 p.m., vital signs were obtained and showed a blood pressure of 183/98 on the right arm (normal 120/80), a blood pressure of and 183/114 on the left arm, and a pain level of 6. Patient 75 was assigned an acuity level 2 (emergent). Patient 75 was placed in a chair in the ED hallway, an EKG was done and laboratory tests were drawn. On April 8, 2019, at 8:50 p.m. (two hours and 30 minutes after the patient's vital signs were obtained) Losartan Potassium (medication used to treat high blood pressure) 50 mg by mouth was ordered, and it was given at 9:12 p.m. The physician wrote a discharge order for Patient 75 to go home on April 8, 2019, at 8:51 p.m. (before the blood pressure was rechecked to see if the medication was effective). At 9:15 p.m., Patient 75's blood pressure was 175/112 (2 hours and 55 minutes after the initial of vital signs were taken). At 9:24 p.m., Patient 75 was provided discharge instructions and, did not want to wait for a BP (blood pressure) re-check. There was no documented indication the physician was informed Patient 75's blood pressure remained elevated at the time of discharge from the facility. During an interview with the EDOM, on April 9, 2019, at 12:50 p.m., she stated Patient 75's vital signs should have been done at least every hour. c. Patient 77 presented to the ED on April 8, 2019, at 3:58 p.m., eight days after delivering a baby, with complaints of fever for three days, vaginal bleeding, and foul smelling vaginal discharge. Patient 77 was triaged at 5:30 p.m., vital signs were obtained and showed a temperature of 102.8¦F (normal 97.7 to 99.5¦F), a heart rate of 122 (normal 60-100), and a pain level of 6. Patient 77 was assigned an acuity level 2 (emergent). A nursing assessment was done at 5:35 p.m. At 9:57 p.m., Patient 77's vital signs were reassessed (4 hours and 27 minutes after the initial set of vital signs was taken). On April 9, 2019, at 8 a.m., a nursing assessment/reassessment was completed (14 hours and 30 minutes after the initial triage assessment). On April 9, 2019, at 11:35 a.m., Patient 77 was still being held in the ED awaiting an inpatient bed, with a diagnosis of endometritis (an inflammatory condition of the lining of the uterus, usually due to an infection). During an interview with the ED Clinical Manager (EDCM) on April 9, 2019, at 1:30 p.m., he stated the vital signs for Patient 77 were delayed, and there should have been an initial nursing assessment followed by reassessments every four hours. d. Patient 52, a [AGE] year old female, presented to the ED on April 8, 2019, at 7:54 p.m., with complaints of chest pain and bilateral calf pain after a six hour airplane flight. Patient 52 was assigned an acuity level 3 (urgent), and placed in a chair. At 8 p.m., Patient 52 had an EKG, with the results showing sinus tachycardia (rapid rate in the heart) with no signs of a myocardial infarction (MI-heart attack). At 8:02 p.m., Patient 52's vital signs were taken and showed a blood pressure of 142/92 and a heart rate of 93. The next vital signs were not taken until 11:50 p.m., 3 hours and 50 minutes later. 3. During a tour of the ED on April 9, 2019, at 10:25 a.m., accompanied by the Assistant Chief Nursing Officer (ACNO), multiple patients were observed lined up in chairs against the wall, in the hallway inside the ED. In a concurrent interview, EDRN C stated there were three nurses assigned to care for patients in the chairs, and they currently had 17 patients they were responsible for in the chairs, plus one patient with a bowel obstruction, around the corner, with a nasogastric tube (a tube inserted through the nose and into the stomach) hooked up to suction. EDRN C stated, most, of the patients had received medications, and, quite a few, had IVs inserted. EDRN C stated pain management was a problem for the patients in the chairs. EDRN C stated they could not administer narcotic pain medications to patients who needed them, because they could not monitor for respiratory depression (decrease in respirations - a potential side effect of narcotic pain medication). EDRN C further stated IV medications that needed to run through a pump were, difficult, to administer, because they did not have a place to plug in the pumps. EDRN C stated they were not able to monitor any of the patients in chairs as closely as they should be monitored. EDRN C stated she felt, bad, for the patients, and it was, very frustrating, that the facility was accepting interfacility transfers who were admitted to inpatient beds, so the ED patients did not have beds to go to. EDRN C stated if the interfacility transfers were not being transferred in, the ED patients would not have to be lined up in the chairs. The record for one of the 17 patients was reviewed and indicated the following: Patient 63, a [AGE] year old male, presented to the ED on April 9, 2019, at 6:04 a.m., with complaints of chest pain, shortness of breath, and leg swelling. Initial vital signs at triage showed a blood pressure of 168/81 (normal 120/80) and a heart rate of 101 (normal 60-100). Patient 63 was assigned a level 3 acuity, and placed in a chair in the hallway. The physician assessment indicated Patient 63 was, mildly tachypneic, (breathing too fast) and had decreased breath sounds. The EKG showed a heart rate of 109. The record indicated at 8:41 a.m., the physician ordered a CAT scan angiogram to rule out a pulmonary embolus (a blood clot in the lung), a breathing treatment, and IV morphine (a narcotic medication that decreases pain, eases the work of breathing, increases the capacity of the blood vessels, and decreases the workload of the heart). There was no evidence the morphine had been administered as of 11:25 a.m. (two hours and 44 minutes after the medication was ordered). 4. During a tour of the ED on April 9, 2019, at 12:40 p.m., accompanied by the ACNO, multiple patients were observed lined up in chairs against the wall, in the hallway inside the ED. In a concurrent interview, EDRN C stated there were two nurses assigned to care for patients in the chairs (as one nurse got pulled to triage), and they currently had 22 patients they were responsible for. The record for one of the 22 patients was reviewed and indicated the following: Patient 67, a [AGE] year old female, presented to the ED on April 9, 2019, with complaints of fever, body aches, and a cough for two weeks. The triage vital signs at 11:28 a.m., showed a blood pressure of 80/53 (normal 120/80) and a heart rate of 122 (normal 60-100). Patient 67 was assigned an acuity level 2, had a mask put on, and was placed in a chair in the hallway. The physician ordered a cardiac monitor, hemodynamic monitoring with pulse oximetry (blood pressure and oxygen level continuously), and an IV antibiotic. Patient 67 was placed in a bed at 12:23 p.m. (55 minutes after being placed in the chair). There was no evidence Patient 67 was placed on a cardiac monitor, had hemodynamic monitoring, or received antibiotics prior to being placed in a bed. 5. A review of Patient 42's record was conducted on April 10, 2019, at 10:20 a.m. Patient 42 was admitted to the facility on [DATE], at 5:23 p.m., with a chief complaint of heaviness to the chest radiating to the left arm. The patient was triaged, vital signs were done, and an acuity level 2 was assigned (Emergent). Patient 42 was placed on outpatient observation status at 7:46 p.m., with a diagnosis of possible sepsis (a severe infection), and an elevated troponin level, (proteins which are released when the heart muscle has been damaged, such as occurs with a heart attack). The record indicated after the patient's vital signs were taken at the time the patient was triaged, vital signs were not rechecked until 10:47 p.m. (five hours and 27 minutes later). On March 27, 2019, at 10:47 p.m., Patient 42 complained of a headache, with pain at a level 10 out of 10 (indicating the highest pain level). The record failed to show a follow up pain assessment after the patient was given Tylenol (pain medication), at 12:51 a.m. An interview was conducted with the ED Clinical Manager (EDCM), on April 10, 2019, at 11:30 a.m., who stated the reassessment of Patient 42's vital signs were delayed, and a reassessment of the patient's pain was not done following the administration of pain medication. The facility policy titled, Admission/Discharge of the Patient to the Emergency Department, was reviewed on April 8, 2019. The policy indicated the following: A. The triage nurse would assign each patient a priority category based on the Canadian Triage and Acuity Scale; B. Category 2 patients were, Emergent, with serious injuries or illnesses who might deteriorate or suffer long term problems if they did not receive very urgent treatment; and, C. Category 3 patients were, Urgent, and would require two or more ED resources for a disposition to be reached. The facility policy titled, Standards of Care, Practice Guidelines and Assessment for the Adult Patient, was reviewed on April 10, 2019. The policy indicated the following: a. ED patients triaged as a level 2 acuity would have vital signs, oxygen saturation level, and pain level monitored every 30 minutes and as needed; b. Patients triaged as a level 3 acuity would have vital signs, oxygen saturation level, and pain level monitored every 60 minutes and as needed; and, c. A follow-up pain assessment was to be done within one hour of treatment for pain. The nursing staffing policy was reviewed on April 10, 2019. The policy indicated the following: A. It was the responsibility of the unit directors, managers, and charge nurses to ensure there were adequate levels of appropriate staff in sufficient quantities to staff their individual units on an ongoing basis; and, B. In the ED, the minimum staffing ratio would be one nurse for every four patients. The facility policy titled, Bed Management Plan, was reviewed on April 10, 2019. The plan indicated the following: a. The purpose was to facilitate efficient patient flow, minimize ED holding time, and maximize utilization of facility resources; b. The definition of, Bed Level III Orange - Inadequate Beds, included beds at capacity and volume of emergency patients exceeded the available clinical resources, increase in ambulance traffic and ED was at full capacity, 15 or more patients were in the ED waiting for inpatient beds, and/or time to treatment goals were not being met; and, c. When Level III occurred, the Liaison (nursing supervisor) would delay non-emergent outside transfers.

Violation Name: QAPI(A-0263)

• Inspection Date: 2019-04-11 (Event ID: TGS511)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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22764 Based on interview and record review, the governing body failed to ensure: 1. Data collected by administration was used to monitor the safety and effectiveness of services in the emergency department (ED), when management reports indicated patient wait times were excessive (Refer to A273); 2. Data collected by the administration was used to identify areas for improvement in the ED, a high risk, high volume, problem prone area (Refer to A283); and, 3. ED Quality Assessment Performance Improvement (QAPI) efforts were aimed at improving quality of care and patient safety, when the governing body was aware of, and they did not respond to, staff concerns regarding quality of care in the ED (Refer to A309). The cumulative effect of these systemic problems resulted in failure to maintain an effective QAPI program, and ensure improvements were made in the care of patients in the ED. 37659

Violation Name: NURSING SERVICES(A-0385)

• Inspection Date: 2016-11-17 (Event ID: 5QTZ11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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22764 Based on observation, interview, and record review, the facility failed to ensure safe administration of medications in accordance with physician's orders, accepted standards of practice, and facility policies and procedures, when: 1. Medications were not available for administration at the time they were due to be given (A405); 2. Medications were withheld without physician's orders or absolute contraindications (a condition or factor that serves as a reason to withhold the medication due to harm it would cause) (A405); and, 3. Insulin was administered in an unsafe manner (A405). The cumulative effect of these systemic problems resulted in failure to ensure nursing services were delivered in a safe and effective manner.

Violation Name: ADMINISTRATION OF DRUGS(A-0405)

• Inspection Date: 2016-11-17 (Event ID: 5QTZ11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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22764 Based on observation, interview, and record review, the facility failed to ensure, for 19 of 51 sampled patients (Patients 14, 15, 16, 17, 21, 23, 33, 34, 35, 38, 44, 46, 47, 48, 49, 50, 51, 52, and 53), safe administration of medications in accordance with physician's orders, accepted standards of practice, and facility policies and procedures, when medications were not available for administration at the time they were due to be given, medications were withheld without physician's orders or absolute contraindications (a condition or factor that serves as a reason to withhold the medication due to harm it would cause), and insulin was administered in an unsafe manner. These failed practices resulted in the potential for ineffective treatment, increased length of hospital stay, harm, and death. Findings: During an interview with the Director of Pharmacy (DOP) and the Lead Pharmacy Technician (LPT) on November 15, 2016, at 1:30 p.m., the LPT stated when medications were not available for nurses to administer at the time they were due, the nurses would complete a missing medication management (MMM) request, in the computer, to alert the pharmacy they did not have the medication for the patient. The LPT stated the reasons for the medications not being available included: A. Nurses placing medications in the wrong location when they were sent to the floor using the tube system; B. Nurses not using the global find application in the automated dispensing cabinet (ADC - used to store and dispense medications as they are needed) and going to nearby ADCs to get the medications; and, C. Nurses not checking the tube systems located outside of their units to see if the medications had been sent. During an interview with Medical Surgical Registered Nurse (MSRN) 1 on November 16, 2016, at 11 a.m., the RN stated if a medication was not available to administer to her patient when it was due to be given, she would complete an MMM in the computer to alert the pharmacy to send the medication to the floor. According to MSRN 1, if a medication was given later than an hour after it was due, the computer would prompt the nurse to explain why it was, late. She stated if the medication was not there to give, she would select the, medication not available, option. MSRN 1 stated in her experience she completed an MMM, because a medication was not available to administer at the time it was due, at least once, every shift, and sometimes more than once in a shift. During an interview with MSRN 2 on November 16, 2016, at 11:10 a.m., MSRN 2 stated if a medication was not available to administer to a patient at the time it was due to be given, she would complete an MMM in the computer and wait to receive the medication from the pharmacy. MSRN 2 stated if the medication did not get sent by the pharmacy before it was late (given more than one hour after it was due), the computer would prompt her to indicate the reason it was given late. The RN stated she would select the, medication not available, option in that circumstance. MSRN 2 stated she did not complete an incident report each time a medication was given late. She stated she did not report to the physician each time a medication was given late. A report titled, Admin Variance October 2016, generated at the request of the survey team, and provided by the facility, was received on November 15, 2016. The report identified patients who received late medications with the reason, medication not available, in October 2016. A second report titled, Admin Variance October 2016, generated at the request of the survey team, and provided by the facility, was received on November 16, 2016. The report identified patients who missed medication doses that were supposed to be given to them in October 2016. Records were reviewed during the facility tour. A random sample of records was reviewed from the, Admin Variance October 2016, reports. The records revealed the following: 1. The record for Patient 16 included the following medication orders: a. September 26, 2016: Valproic Acid (to treat seizure disorders) 500 mg (milligrams), two capsules to be given once daily by mouth. According to the eMAR (electronic medication administration record): - On September 30, 2016, the 9 a.m. dose was administered at 12:11 a.m. (three hours and 11 minutes after it was due). The reason for the late administration was not indicated by the nurse. There was no evidence the physician was notified of the late medication administration; - On October 1, 2016, the 9 a.m. dose was administered at 12:55 p.m. (three hours and 55 minutes after it was due). The reason for the late administration was documented as medication not available. There was no evidence the physician was notified of the late medication administration; and, - On October 3, 2016, the 9 a.m. dose was administered at 3:44 p.m. (six hours and 44 minutes after it was due). The reason for the late administration was documented as medication not available. There was no evidence the physician was notified of the late medication administration. b. September 26, 2016: Entecavir (to treat liver infection caused by hepatitis B) 1 mg to be given once daily by mouth. According to the eMAR: - On September 26, 2016, the 9 a.m. dose was administered at 2:48 p.m. (five hours and 48 minutes after it was due). The reason for the late administration was not indicated by the nurse. There was no evidence the physician was notified of the late medication administration; - On September 27, 2016, the 9 a.m. dose was administered at 6:45 p.m. (nine hours and 45 minutes after it was due). The reason for the late administration was documented as medication not available. There was no evidence the physician was notified of the late medication administration; - On September 30, 2016, the 9 a.m. dose was administered at 12:10 p.m. (three hours and 10 minutes after it was due). The reason for the late administration was documented as medication not available. There was no evidence the physician was notified of the late medication administration; - On October 1, 2016, the 9 a.m. dose was administered at 12:56 p.m. (three hours and 56 minutes after it was due). The reason for the late administration was documented as medication not available. There was no evidence the physician was notified of the late medication administration; - On October 3, 2016, the 9 a.m. dose was administered at 3:45 p.m. (six hours and 45 minutes after it was due). The reason for the late administration was documented as medication not available. There was no evidence the physician was notified of the late medication administration; - On October 8, 2016, the 9 a.m. dose was administered at 12:54 a.m. (three hours and 54 minutes after it was due). The reason for the late administration was not indicated by the nurse. There was no evidence the physician was notified of the late medication administration; - On October 10, 2016, the 9 a.m. dose was administered at 11:27 a.m. (two hours and 27 minutes after it was due). The nurse indicated the medication had been requested from the pharmacy. There was no evidence the physician was notified of the late medication administration; - On October 11, 2016, the 9 a.m. dose was administered at 11:57 a.m. (two hours and 57 minutes after it was due). The reason for the late administration was not indicated by the nurse. There was no evidence the physician was notified of the late medication administration; - On October 12, 2016, the 9 a.m. dose was administered at 12:07 p.m. (three hours and seven minutes after it was due). The nurse indicated the medication was sent up in the tube system by the pharmacy late. There was no evidence the physician was notified of the late medication administration; - On October 13, 2016, the 9 a.m. dose was administered at 2:43 p.m. (five hours and 43 minutes after it was due). The nurse indicated, Pharmacy just sent it. There was no evidence the physician was notified of the late medication administration; - On October 15, 2016, the 9 a.m. dose was administered at 11:22 a.m. (two hours and 22 minutes after it was due). The reason for the late administration was not indicated by the nurse. There was no evidence the physician was notified of the late medication administration; - On October 16, 2016, the 9 a.m. dose was administered at 5:14 p.m. (eight hours and 14 minutes after it was due). The nurse indicated, hospital is out, no shipment for two days. There was no evidence the physician was notified of the late medication administration; c. October 8, 2016: Mirtazapine (an antidepressant) 15 mg to be given by mouth at bedtime. According to the eMAR: - On October 8, 2016, the 9 p.m. dose was administered at 10:57 p.m. (one hour and fifty seven minutes after it was due). The reason for the late administration was documented as medication not available. There was no evidence the physician was notified of the late medication administration. - On October 9, 2016, the 9 p.m. dose was administered at 10:59 p.m. (one hour and fifty nine minutes after it was due). The reason for the late administration was documented as medication not available. There was no evidence the physician was notified of the late medication administration. Concurrent interview with the Pharmacy Clinical Manger was conducted. She stated this was a scheduled medication and the medication should have been available. 2. The record for Patient 38 included the following medication orders: a. February 25, 2016: Cefepime (an antibiotic) one gram to be given IV (intravenously - into the vein) every eight hours. According to the eMAR: - On February 28, 2016, the 8 a.m. dose was administered at 10:16 a.m. (two hours and 16 minutes after it was due). The reason for the late administration was not indicated by the nurse. There was no evidence the physician was notified of the late medication administration; - On February 28, 2016, the 4 p.m. dose was administered at 5:53 p.m. (one hour and 53 minutes after it was due). The reason for the late administration was not indicated by the nurse. There was no evidence the physician was notified of the late medication administration; and, - On February 29, 2016, the 8 a.m. dose was not administered to the patient. The reason for the missed dose was documented as medication not available. There was no indication the physician was notified of the missed dose of medication. b. On February 27, 2016: Metronidazole (an antibiotic) 500 mg IV to be given every eight hours. According to the eMAR: - On February 28, 2016, the 6 a.m. dose was administered at 7:12 a.m. (one hour and 12 minutes after it was due). The reason for the late administration was not indicated by the nurse. There was no evidence the physician was notified of the late medication administration; - On February 29, 2016, the 6 a.m. dose was not administered to the patient. The reason for the missed dose was documented as medication not available. There was no indication the physician was notified of the missed dose of medication; and, - On March 1, 2016, the 10 p.m. dose was administered on March 2, 2016, at 2:50 a.m. (four hours and 59 minutes after it was due). The reason for the late administration was not indicated by the nurse. There was no evidence the physician was notified of the late medication administration. c. February 28, 2016: Albumin (a human protein used to maintain the patient's blood volume and healing abilities) 500 ml (milliliters) to be given IV every eight hours. According to the eMAR: - On February 29, 2016, the 2 p.m. dose was administered at 5:16 p.m. (two hours and 16 minutes after it was due). The reason for the late administration was not indicated by the nurse. There was no evidence the physician was notified of the late medication administration. 3. The record for Patient 46 included an order dated October 6, 2016, for Fidaxomicin (an antibiotic) 200 mg to be given twice a day by mouth. According to the eMAR: - On October 6, 2016, the 9 p.m. dose was not administered. The reason for the missed dose was documented by the nurse as medication not available. There was no evidence the physician was notified of the late medication administration; - On October 7, 2016, the 9 p.m. dose was administered at 10:52 p.m. (one hour and 52 minutes after it was due). The reason for the late administration was documented by the nurse as medication not available. There was no evidence the physician was notified of the late medication administration; and, - On October 8, 2016, the 9 a.m. dose was administered at 6:47 p.m. (nine hours and 47 minutes after it was due, and two hours and 13 minutes before the next dose - which was given on time - was due). The reason for the late administration was documented by the nurse as medication not available. There was no evidence the physician was notified of the late medication administration. 4. The record for Patient 47 included an order dated September 26, 2016, for Albumin 250 ml, two bottles, to be given IV 1 hour apart. According to the eMAR: - On October 26, 2016, the first bottle, due at 6:45 p.m., was administered at 11:59 p.m. (five hours and 14 minutes after it was due). The reason for the late administration was documented by the nurse as medication not available. There was no evidence the physician was notified of the late medication administration. 5. The record for Patient 48 included an order dated October 4, 2016, for Clindamycin (an antibiotic) 450 mg to be given every eight hours by mouth. According to the eMAR: - On October 6, 2016, the morning dose (due at 9:51 a.m.) was administered at 1:04 p.m. (three hours and 13 minutes after it was due). The reason for the late administration was documented by the nurse as medication not available. There was no evidence the physician was notified of the late medication administration. 6. The record for Patient 49 included an order dated October 24, 2016, for Clindamycin 600 mg to be given IV every eight hours. According to the eMAR: - On October 24, 2016, the dose due at 7:30 p.m. was administered on October 25, 2016 (the next morning) at 4:46 a.m. (nine hours and 16 minutes after it was due). The reason for the late administration was documented by the nurse as medication not available. There was no evidence the physician was notified of the late medication administration. 7. The record for Patient 50 included an order dated October 20, 2016, for 20 mEq (milliequivalents) of KCL (a potassium supplement) to be added to the IV fluids. According to the eMAR: - On October 20, 2016, the first dose, due at 12:43 p.m., was started at 6:23 p.m. (five hours and 40 minutes after it was due). The reason for the late administration was documented by the nurse as medication not available. There was no evidence the physician was notified of the late medication administration. 8. The record for Patient 51 included an order dated October 22, 2016, for Nifedipine (to treat high blood pressure) 90 mg to be given by mouth daily. According to the eMAR: - On October 23, 2016, the 9 a.m. dose was administered at 1:53 p.m. (four hours and 53 minutes after it was due). The reason for the late administration was documented by the nurse as medication not available. There was no evidence the physician was notified of the late medication administration. 9. The record for Patient 52 included an order dated October 12, 2016, for Actos (for treatment of type 2 diabetes) 30 mg to be given by mouth daily. According to the eMAR: - On October 13, 2016, the 9 a.m. dose was administered at 12:13 p.m. (three hours and 13 minutes after it was due). The reason for the late administration was documented by the nurse as medication not available. There was no evidence the physician was notified of the late medication administration; and, - On October 14, 2016, the 9 a.m. dose was administered at 11:07 a.m. (two hours and seven minutes after it was due). The reason for the late administration was documented by the nurse as medication not available. There was no evidence the physician was notified of the late medication administration. 10. The record for Patient 53 included an order dated October 19, 2016, for a GI cocktail (a mixture of three different medications used to treat abdominal pain) to be given by mouth every 12 hours. According to the eMAR: - On October 19, 2016, the 10:30 p.m. dose was administered on October 20, 2016, at 1:54 a.m. (three hours and 24 minutes after it was due). The reason for the late administration was documented by the nurse as medication not available. There was no evidence the physician was notified of the late medication administration; - On October 26, 2016, the 10:30 a.m. dose was administered at 12:56 p.m. (two hours and 26 minutes after it was due). The reason for the late administration was not documented by the nurse. There was no evidence the physician was notified of the late medication administration; - On October 28, 2016, the 10:30 a.m. dose was not administered. The reason for the missed dose was documented by the nurse as medication not available. There was no evidence the physician was notified of the missed medication dose; and, - On November 1, 2016, the 10:30 a.m. dose was administered at 12:48 p.m. (two hours and 18 minutes after it was due). The reason for the late administration was documented by the nurse as, Barcode won't scan. 11. The record for Patient 44, a dialysis patient, included the following orders: a. Ceftriaxone (an antibiotic) two grams to be given IV every day. The scheduled time for administration was 5 p.m. The order did not include instructions to hold the medication for dialysis. According to the eMAR: - On November 14, 2016, the 5 p.m. dose was administered at 7:59 p.m. (two hours and 49 minutes after it was due). The reason for the late administration was documented by the nurse as, Pt (patient) was on dialysis. There was no evidence the physician was notified of the late medication administration. During an interview with MS RN 2 on November 16, 2016, at 11:10 a.m. the nurse stated if a patient had medications due during a dialysis treatment, she would check with the dialysis nurse to see if they would be, dialyzed out (removed from the blood stream during dialysis, making them ineffective). MS RN 2 stated if the medication would not be dialyzed out, she would give it on time during the dialysis treatment. During a tour of the Medical Surgical unit on November 16, 2016, at 12:10 p.m., Patient 44 was observed receiving a dialysis treatment by Dialysis Nurse (DN) 1. During a concurrent interview, the DN stated Patient 44 had her dialysis treatment on November 14, 2016, from 3:40 p.m. to 7:10 p.m., and he was the nurse who performed the dialysis. The DN stated the nurse did not check with him to see whether Ceftriaxone was dialyzed out. He stated the medication was not affected by dialysis, and could have been administered at the time it was due. According to the National Center for Biotechnology Information (NCBI), ceftriaxone is not affected by hemodialysis; and, b. Micafungin (to treat a fungal infection) 100 mg to be given IV every day. The scheduled time for administration was 7:24 p.m. According to the eMAR: - On November 15, 2016, the medication was administered at 20 minutes after midnight (four hours and 56 minutes after it was due). The reason for the late administration was documented by the nurse as, Was awaiting delivery from the pharmacy. There was no evidence the physician was notified of the late medication administration. 34435 12. The record for Patient 14 included the following medication orders: a. October 20, 2016, Potassium Chloride (a potassium supplement) 40 mEq to be given at 1 p.m. According to the eMAR: - On October 20, 2016, the 1 p.m. dose was administered at 3:01 p.m. (two hours and one minute after it was due). The reason for the late administration was documented as medication not available. There was no evidence the physician was notified of the late medication administration. b. October 21, 2016, Potassium Chloride 40 mEq to be given at 9 a.m. According to the eMAR: - On October 21, 2016, the 9 a.m. dose was administered at 3:56 p.m. (six hours and fifty six minutes after it was due). The reason for the late administration was documented as medication not available. There was no evidence the physician was notified of the late medication administration. 13. The record for Patient 15 included the following medication orders: a. October 14, 2016, Potassium Chloride 40 mEq to be given IV at 9:30 a.m. According to the eMAR: - On October 14, 2016, the 9:30 a.m. dose was administered at 12:46 p.m. ( three hours and sixteen minutes after it was due). The reason for the late administration was documented as medication not available. There was no evidence the physician was notified of the late medication administration. b. October 16, 2016, Potassium Chloride 40 mEq to be given IV at 10:42 a.m. According to the eMAR: - On October 16, 2016, the 10:42 dose was administered at 12:33 p.m. (one hour and fifty one minutes after it was due). The reason for the late administration was documented as medication not available. There was no evidence the physician was notified of the late medication administration. 14. The record for Patient 17 included the following medication orders: a. October 2, 2016, Nafcillin (an antibiotic) 2 grams to be given IV every four hours. According to the eMAR: - On October 2, 2016, the 5 p.m. dose was administered at 6:28 p.m. (one hour and twenty eight minutes after it was due). The reason for the late administration was documented as medication not available. There was no evidence the physician was notified of the late medication administration; - On October 6, 2016, the 5 a.m. dose was administered at 6:03 a.m. (one hour and three minutes after it was due). The reason for the late administration was documented as medication not available. There was no evidence the physician was notified of the late medication administration; and, - On October 10, 2016, the 9 a.m. dose was administered at 10:29 a.m. (one hour and twenty nine minutes after it was due). The reason for the late administration was documented as medication not available. There was no evidence the physician was notified of the late medication administration. 15. The record of Patient 23 included the following medication orders: a. November 9, 2016: Meropenem (an antibiotic) 500 milligrams to be given IV every 12 hours. According to the eMAR: - On November 9, 2016, the 9 p.m. dose was administered at 11:28 p.m. (two hours and twenty eight minutes after it was due). The reason for the late administration was not indicated by the nurse. There was no evidence the physician was notified of the late medication administration. b. November 9, 2016: Nystatin/Triamcinolone (treatment for skin infection) 15 grams to be applied twice a day. According to the eMAR: - On November 9, 2016, the 9 p.m. dose was not administered to the patient. The reason for the missed dose was documented as medication not available. There was no indication the physician was notified of the missed dose of medication. c. November 11, 2016: Tigecycline (an antibiotic) 50 milligrams to be given IV every 12 hours. According to the eMAR: - On November 11, 2016, the 5:08 p.m. dose was administered at 8:58 p.m. (three hours and fifty minutes after it was due). The reason for the late administration was documented as medication not available. There was no evidence the physician was notified of the late medication administration. 16. The record for Patient 33 included a order dated October 13, 2016, for Ranolazine ER (heart medication - extended release) 500 milligrams by mouth twice a day. According to the eMAR: - On October 14, 2016, the 9 a.m. dose was administered at 10:53 a.m. (one hour and fifty three minutes after it was due). The reason for the late administration was documented as medication not available. There was no evidence the physician was notified of the late medication administration; - On October 15, 2016, the 9 a.m. dose was administered at 11:29 a.m. (two hours and twenty nine minutes after it was due). The reason for the late administration was documented as medication not available. There was no evidence the physician was notified of the late medication administration, and; - On October 17, 2016, the 9 a.m. dose was administered at 11:59 a.m. (two hours and fifty nine minutes after it was due). The reason for the late administration was documented as medication not available. There was no evidence the physician was notified of the late medication administration. 17. The record for Patient 34 included an order dated October 12, 2016, for Ceftriaxone (an antibiotic) two grams to be given IV (intravenously - into the vein) daily. According to the eMAR: - On October 13, 2016, the 9 a.m. dose was administered at 3:04 p.m. (six hours and four minutes after it was due). The reason for the late administration was documented as medication not available. There was no evidence the physician was notified of the late medication administration; - On October 14, 2016, the 9 a.m. dose was administered at 1:59 p.m. (four hours and fifty nine minutes after it was due). The reason for the late administration was documented as medication not available. There was no evidence the physician was notified of the late medication administration; - On October 15, 2016, the 9 a.m. dose was administered at 10:13 a.m. (one hour and thirteen minutes after it was due). The reason for the late administration was documented as medication not available. There was no evidence the physician was notified of the late medication administration, and; - On October 17, 2016, the 9 a.m. dose was not administered to the patient. The reason for the missed dose was documented as medication not available .called pharmacy twice still no atbx (antibiotic) sent by the end of shift. There was no indication the physician was notified of the missed dose of medication. 18. The record for Patient 35 included an order dated October 2, 2016, for Ceftriaxone (an antibiotic) two grams to be given IV daily. According to the eMAR: - On October 3, 2016, the 9 a.m. dose was administered at 11:35 a.m. (two hours and thirty five minutes after it was due). The reason for the late administration was documented as medication not available. There was no evidence the physician was notified of the late medication administration; and, - On October 4, 2016, the 9 a.m. dose was administered at 11:52 a.m. (two hours and fifty two minutes after it was due). The reason for the late administration was documented as medication not available. There was no evidence the physician was notified of the late medication administration. 19. The record for Patient 21 included the following medication orders: a. November 5, 2016, Regular Insulin (short acting insulin) 100 unit/milliliter to be given subcutaneous (under the skin) every four hours as follows: for blood sugar 121-150 = 4 units for blood sugar 151-200 = 6 units for blood sugar 201-250 = 8 units for blood sugar 251-300 = 10 units for blood sugar 301-350 = 12 units for blood sugar 351-450 = 14 units for blood sugar greater than or equal to 400 = call MD (doctor). According to the eMAR: - On November 5, 2016, the 5:56 p.m. dose was given at 7:55 p.m. (two hours after it was due). Patient 21 was given 8 units of insulin, for a blood sugar level of 201 obtained at 7:47 p.m. The reason for the late administration was documented as SHOULD HAVE BEEN GIVEN BY DAY SHIFT RN. There was no evidence the physician was notified of the late medication administration, and; - On November 5, 2016, the 9:56 p.m. dose was given at 10:55 p.m. (one hour after it was due and only three hours after the last dose). Patient 21 was given 4 units of insulin, for a blood sugar level of 150 obtained at 10:52 p.m. The reason for the late administration was not indicated by the nurse. There was no evidence the physician was notified of the late medication administration. The multidisciplinary notes dated November 11, 2016, at 1:11 a.m. indicated PT (patient) FINGER GLUCOSE 62 mg/dl (too low - hypoglycemia - blood glucose below 70 milligram per deciliter) . The note further indicated Patient 21 had to be given 12.5 grams of dextrose 50 % (indicated in the treatment of insulin induced hypoglycemia to restore the blood glucose level). [CARRIAGE RETURN

Violation Name: QAPI(A-0263)

• Inspection Date: 2016-11-17 (Event ID: 5QTZ11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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22764 Based on interview and record review, the facility failed to: 1. Adequately monitor the safety and effectiveness of the medication administration process by failing to measure and analyze relevant data that was available to them through their information technology system (A273, A405); and, 2. Develop and implement effective procedures to control the use of all controlled substances(CSs), readily identify and resolve CS discrepancies, and minimize the potential time of diversion of CS (A494). The cumulative effect of these systemic problems resulted in failure to ensure an effective Quality Assessment and Performance Improvement program focused on reducing errors and improving patient safety.

Violation Name: DATA COLLECTION & ANALYSIS(A-0273)

• Inspection Date: 2016-11-17 (Event ID: 5QTZ11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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22764 Based on interview and record review, the facility failed to adequately monitor the safety and effectiveness of the medication administration process by failing to measure and analyze relevant data that was available to them through their information technology system. This failed practice resulted in multiple medication errors not identified by the facility, and the potential for patient harm or death. Findings: The facility Performance Improvement and Patient Safety Plan revised March 2016, was reviewed on October 15, 2016. The plan indicated it was designed to improve performance and patient safety, ultimately reducing risks to patients. The goals of the plan included: 1. Reducing medical/health system errors and hazardous conditions by creating an environment in which actual or potential risks to patient safety could be managed; and, 2. Ensuring the use of continuous process improvement throughout the organization by focusing on interdisciplinary collaboration and cooperation of all services. The plan indicated the facility leaders were responsible for the establishment of clear expectations of safety, including compliance with the 2016 National Patient Safety Goals (NPSG). The 2016 NPSG #3 was to improve the safety of using medications. During the Quality Assessment Performance Improvement (QAPI) interview on November 15, 2016, at 10 a.m., the Director of Pharmacy (DOP) stated late administration of medications and missed doses were not accurately reflected in the quarterly medication error reports, because only the errors reported by staff, using the incident reporting system, were included. He stated the pharmacy did not review medications returned to the pharmacy to determine why they were not administered. He stated he did not use the information entered into the computers by the patient care staff, as he did not have access to the system used for documentation of medication administration, and he was unaware of the type of data he could retrieve from the system. The DOP stated the pharmacy did not generate reports, look for trends, or identify the reasons for late medication administrations or missed doses to determine what corrective actions could be taken to prevent further errors. During an interview with the [NAME] President of Quality (VPQ) on November 16, 2016, at 7 a.m., the Medication Event Reports, for the first three quarters of 2016 were reviewed. The reports indicated the following: 1. For the first quarter (Jan, Feb, March) of 2016: a. Medications administered at the wrong time: 9 b. Missed doses of medication: 10 2. For the second quarter (April, May, June) of 2016: a. Medications administered at the wrong time: 4 b. Missed doses of medication: 5 3. For the third quarter (July, August, September) of 2016: a. Medications administered at the wrong time: 4 b. Missed doses of medication: 6 The VPQ stated all of the events reviewed were based on incident reports completed by facility staff. A report titled, Admin Variance October 2016, generated at the request of the survey team, and provided by the facility, was received on November 15, 2016. The report identified patients who received late medications with the reason, medication not available, in October 2016. A second report titled, Admin Variance October 2016, generated at the request of the survey team, and provided by the facility, was received on November 16, 2016. The report identified patients who missed medication doses that were supposed to be given to them in October 2016. A review of the two reports indicated for the month of October 2016 (31 days): a. Medications administered at the wrong time: 616 (vs an average of 6 per quarter (90 days) that were identified in the facility medication event reports); and, b. Missed doses of medication: 634 (vs an average of 7 per quarter (90 days) that were identified in the facility medication event reports) During a Quality Assessment and Performance Improvement (QAPI) interview with the Director of Pharmacy (DOP), the Chief Nursing Officer (CNO), the Assistant Chief Nursing Officer (ACNO), and the [NAME] President of Quality (VPQ) on November 16, 2016, at 10 a.m., the leaders stated they were aware the nurses in the Intensive Care Unit (ICU) were, frustrated, with the number of medications that were not available. The leaders stated they did not know the unavailability of medications, missed medications, and omitted doses, were occurring throughout the facility. According to American Society of Health-System Pharmacists (ASHP), a nationally recognized pharmacist organization, in its publication, ASHP Guidelines on Preventing Medication Errors in Hospitals, .Omission error: The failure to administer an ordered dose to a patient before the next scheduled dose, if any . Wrong time error: Administration of medication outside a predefined time interval from its scheduled . Pharmacy staff should review medications that are returned to the department. Such review processes may reveal system breakdowns or problems that resulted in medication errors (e.g., omitted doses and unauthorized drugs) . According to ASHP publication, ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals, Reviewing Patient Responses to Medication Therapy. Medication therapy monitoring shall be conducted by pharmacists. Medication therapy monitoring includes a proactive assessment of patient problems and an assessment of .Therapeutic duplication or omissions in the patient's medication regimen . The pharmacy and nursing leaders were not aware of the ongoing, widespread problem of late medications and missed medication doses (medication errors) being made throughout the facility.

Violation Name: Standard-level Tag for Pharmaceutical Service(A-0490)

• Inspection Date: 2016-11-17 (Event ID: 5QTZ11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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25281 Based on observation, interview, and record review, the facility failed to provide pharmaceutical services that met the needs of the patients by failing to ensure: 1. Effective procedures were developed and implemented to: a. Control the use of all controlled substances(CSs); b. Readily identify and resolve CS discrepancies; and, c. Minimize the potential time of diversion of CS (A494); 2. Medications were available to the nursing staff for timely administration to patients (A500); 3. Emergency medication supplies in the adult crash carts were stocked in accordance with the current facility policy and procedure (See A500); 4. No medications were left at the patient's bedside without a physician's order in accordance with the facility policy and procedure (A500); and, 5. Cleaning of the Pharmacy IV (intravenous) compounding area was performed in accordance with the facility policy and procedure, and consistent with the federal United States Pharmacopeia (USP) <797> standards (A501). The cumulative effect of these systemic problems resulted in the hospital's failure to ensure the provision of pharmaceutical services in a safe and effective manner that met the needs of their patients.

Violation Name: PHARMACY DRUG RECORDS(A-0494)

• Inspection Date: 2016-11-17 (Event ID: 5QTZ11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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25281 Based on interview and record review, the facility failed to ensure effective procedures were developed and implemented to control the use of all controlled substances(CSs), readily identify and resolve CS discrepancies, and minimize the potential time of diversion of CS. These failed practices resulted in the potential for diversion of CS away from patients, ineffective treatment of patients, and harm or death in patients and healthcare providers. Findings: During an interview with Pharmacy Technician (PT) 1 and the Director of Pharmacy (DOP) on November 16, 2016, at 3:15 p.m., PT 1 stated anesthesia records for surgical cases were sent to the Pharmacy on a daily basis. PT 1 stated she reviewed 10% of the records every quarter for accurate documentation of CS used by the anesthesiologists, and audited the records to ensure all CSs accessed from the Pyxis machine (an automated dispensing cabinet for medications) were accurately accounted for. PT 1 stated it took her several days to review 10% of three months of anesthesia records each quarter. PT 1 stated quarterly reports would identify anesthesiologists with CS discrepancies below the compliance rate of 90%. PT 1 stated CS discrepancies were identified, but they were not followed through by the pharmacy to resolve them. In a concurrent interview, the DOP stated anesthesiologists whose compliance rate failed to reach the minimum of 90% were identified and reported to the Chief of Anesthesiology for follow-up. The DOP stated he did not know if the discrepancies had been resolved. He stated he did not follow up to determine the action taken to resolve the discrepancy. The facility policy and procedure titled, Medication Diversion Prevention Policy last revised, September 2015, read, in part: Anesthesia and Operational Medications (Operating Room and other Anesthetizing Areas) . All discrepancies will be resolved by the provider by the end of the provider's shift . All discrepancies must be tracked, using the QI/PI (Quality Improvement/Performance Improvement) process, by provider, for trending and identification (as defined by the Medical Executive Committee), and reported to the Multidisciplinary Medication Diversion Team . The DOP was not tracking or trending discrepancies to identify possible patterns and prevent diversion of CS.

Violation Name: DELIVERY OF DRUGS(A-0500)

• Inspection Date: 2016-11-17 (Event ID: 5QTZ11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** 25281 Based on observation, interview, and record review, the pharmacy failed to ensure effective control and distribution of medications by failing to ensure: 1. Medications were available to the nursing staff for timely administration to patients; 2. Emergency medication supplies in the adult crash carts were stocked in accordance with the current facility policy and procedure; and, 3. No medications were left at the patient's bedside without a physician's order in accordance with the facility policy and procedure. These failed practices resulted in multiple medication errors related to late or missed doses, and the potential for delay in emergency treatment, patient harm, or death. Findings: 1. During an interview with the Director of Pharmacy (DOP) and the Lead Pharmacy Technician (LPT) on November 15, 2016, at 1:30 p.m., the LPT stated when medications were not available for nurses to administer at the time they were due, the nurses would complete a missing medication management (MMM) request, in the computer, to alert the pharmacy they did not have the medication for the patient. During an interview with Medical Surgical Registered Nurse (MSRN) 1 on November 16, 2016, at 11 a.m., the RN stated if a medication was not available to administer to her patient when it was due to be given, she would complete an MMM in the computer to alert the pharmacy to send the medication to the floor. According to MSRN 1, if a medication was given later than an hour after it was due, the computer would prompt the nurse to explain why it was, late. She stated if the medication was not there to give, she would select the, medication not available, option. MSRN 1 stated in her experience she completed an MMM, because a medication was not available to administer at the time it was due, at least once, every shift, and sometimes more than once in a shift. During an interview with MSRN 2 on November 16, 2016, at 11:10 a.m., MSRN 2 stated if a medication was not available to administer to a patient at the time it was due to be given, she would complete an MMM in the computer and wait to receive the medication from the pharmacy. MSRN 2 stated if the medication did not get sent by the pharmacy before it was late (given more than one hour after it was due), the computer would prompt her to indicate the reason it was given late. The RN stated she would select the, medication not available, option in that circumstance. A report titled, Admin Variance October 2016, generated at the request of the survey team, and provided by the facility, was received on November 15, 2016. The report identified patients who received late medications with the reason, medication not available, in October 2016. A second report titled, Admin Variance October 2016, generated at the request of the survey team, and provided by the facility, was received on November 16, 2016. The report identified patients who missed medication doses that were supposed to be given to them in October 2016. Records were reviewed during the facility tour. A random sample of records was reviewed from the, Admin Variance October 2016, reports. The records revealed the following: A. The record for Patient 16 included the following medication orders: aa. September 26, 2016: Valproic Acid (to treat seizure disorders) 500 mg (milligrams), two capsules to be given once daily by mouth. According to the eMAR (electronic medication administration record): - On October 1, 2016, the 9 a.m. dose was administered at 12:55 p.m. (three hours and 55 minutes after it was due). The reason for the late administration was documented as medication not available; and, - On October 3, 2016, the 9 a.m. dose was administered at 3:44 p.m. (six hours and 44 minutes after it was due). The reason for the late administration was documented as medication not available. bb. September 26, 2016: Entecavir (to treat liver infection caused by hepatitis B) 1 mg to be given once daily by mouth. According to the eMAR: - On September 27, 2016, the 9 a.m. dose was administered at 6:45 p.m. (nine hours and 45 minutes after it was due). The reason for the late administration was documented as medication not available; - On September 30, 2016, the 9 a.m. dose was administered at 12:10 p.m. (three hours and 10 minutes after it was due). The reason for the late administration was documented as medication not available; - On October 1, 2016, the 9 a.m. dose was administered at 12:56 p.m. (three hours and 56 minutes after it was due). The reason for the late administration was documented as medication not available; - On October 3, 2016, the 9 a.m. dose was administered at 3:45 p.m. (six hours and 45 minutes after it was due). The reason for the late administration was documented as medication not available; - On October 10, 2016, the 9 a.m. dose was administered at 11:27 a.m. (two hours and 27 minutes after it was due). The nurse indicated the medication had been requested from the pharmacy; - On October 12, 2016, the 9 a.m. dose was administered at 12:07 p.m. (three hours and seven minutes after it was due). The nurse indicated the medication was sent up in the tube system by the pharmacy late; - On October 13, 2016, the 9 a.m. dose was administered at 2:43 p.m. (five hours and 43 minutes after it was due). The nurse indicated, Pharmacy just sent it; and, - On October 16, 2016, the 9 a.m. dose was administered at 5:14 p.m. (eight hours and 14 minutes after it was due). The nurse indicated, hospital is out, no shipment for two days. cc. October 8, 2016: Mirtazapine (an antidepressant) 15 mg to be given by mouth at bedtime. According to the eMAR: - On October 8, 2016, the 9 p.m. dose was administered at 10:57 p.m. (one hour and fifty seven minutes after it was due). The reason for the late administration was documented as medication not available; and, - On October 9, 2016, the 9 p.m. dose was administered at 10:59 p.m. (one hour and fifty nine minutes after it was due). The reason for the late administration was documented as medication not available. ; A concurrent interview with the Pharmacy Clinical Manager was conducted. She stated this was a scheduled medication and the medication should have been available. B. The record for Patient 38 included the following medication orders: aa. February 25, 2016: Cefepime (an antibiotic) one gram to be given IV (intravenously - into the vein) every eight hours. According to the eMAR: - On February 29, 2016, the 8 a.m. dose was not administered to the patient. The reason for the missed dose was documented as medication not available. bb. On February 27, 2016: Metronidazole (an antibiotic) 500 mg IV to be given every eight hours. According to the eMAR: - On February 29, 2016, the 6 a.m. dose was not administered to the patient. The reason for the missed dose was documented as medication not available. C. The record for Patient 46 included an order dated October 6, 2016, for Fidaxomicin (an antibiotic) 200 mg to be given twice a day by mouth. According to the eMAR: - On October 6, 2016, the 9 p.m. dose was not administered. The reason for the missed dose was documented by the nurse as medication not available; - On October 7, 2016, the 9 p.m. dose was administered at 10:52 p.m. (one hour and 52 minutes after it was due). The reason for the late administration was documented by the nurse as medication not available; and, - On October 8, 2016, the 9 a.m. dose was administered at 6:47 p.m. (nine hours and 47 minutes after it was due, and two hours and 13 minutes before the next dose - which was given on time - was due). The reason for the late administration was documented by the nurse as medication not available. D. The record for Patient 47 included an order dated September 26, 2016, for Albumin 250 ml, two bottles, to be given IV 1 hour apart. According to the eMAR: - On October 26, 2016, the first bottle, due at 6:45 p.m., was administered at 11:59 p.m. (five hours and 14 minutes after it was due). The reason for the late administration was documented by the nurse as medication not available. E. The record for Patient 48 included an order dated October 4, 2016, for Clindamycin (an antibiotic) 450 mg to be given every eight hours by mouth. According to the eMAR: - On October 6, 2016, the morning dose (due at 9:51 a.m.) was administered at 1:04 p.m. (three hours and 13 minutes after it was due). The reason for the late administration was documented by the nurse as medication not available. F. The record for Patient 49 included an order dated October 24, 2016, for Clindamycin 600 mg to be given IV every eight hours. According to the eMAR: - On October 24, 2016, the dose due at 7:30 p.m. was administered on October 25, 2016 (the next morning) at 4:46 a.m. (nine hours and 16 minutes after it was due). The reason for the late administration was documented by the nurse as medication not available. G. The record for Patient 50 included an order dated October 20, 2016, for 20 mEq (milliequivalents) of KCL (a potassium supplement) to be added to the IV fluids. According to the eMAR: - On October 20, 2016, the first dose, due at 12:43 p.m., was started at 6:23 p.m. (five hours and 40 minutes after it was due). The reason for the late administration was documented by the nurse as medication not available. H. The record for Patient 51 included an order dated October 22, 2016, for Nifedipine (to treat high blood pressure) 90 mg to be given by mouth daily. According to the eMAR: - On October 23, 2016, the 9 a.m. dose was administered at 1:53 p.m. (four hours and 53 minutes after it was due). The reason for the late administration was documented by the nurse as medication not available. I. The record for Patient 52 included an order dated October 12, 2016, for Actos (for treatment of type 2 diabetes) 30 mg to be given by mouth daily. According to the eMAR: - On October 13, 2016, the 9 a.m. dose was administered at 12:13 p.m. (three hours and 13 minutes after it was due). The reason for the late administration was documented by the nurse as medication not available; and, - On October 14, 2016, the 9 a.m. dose was administered at 11:07 a.m. (two hours and seven minutes after it was due). The reason for the late administration was documented by the nurse as medication not available. J. The record for Patient 53 included an order dated October 19, 2016, for a GI cocktail (a mixture of three different medications used to treat abdominal pain) to be given by mouth every 12 hours. According to the eMAR: - On October 19, 2016, the 10:30 p.m. dose was administered on October 20, 2016, at 1:54 a.m. (three hours and 24 minutes after it was due). The reason for the late administration was documented by the nurse as medication not available; - On October 28, 2016, the 10:30 a.m. dose was not administered. The reason for the missed dose was documented by the nurse as medication not available; and, - On November 1, 2016, the 10:30 a.m. dose was administered at 12:48 p.m. (two hours and 18 minutes after it was due). The reason for the late administration was documented by the nurse as, Barcode won't scan. K. The record for Patient 44, a dialysis patient, included an order dated November 15, 2016, for Micafungin (to treat a fungal infection) 100 mg to be given IV every day. The scheduled time for administration was 7:24 p.m. According to the eMAR: - On November 15, 2016, the medication was administered at 20 minutes after midnight (four hours and 56 minutes after it was due). The reason for the late administration was documented by the nurse as, Was awaiting delivery from the pharmacy. L. The record for Patient 14 included the following medication orders: aa. October 20, 2016, Potassium Chloride (a potassium supplement) 40 mEq to be given at 1 p.m. According to the eMAR: - On October 20, 2016, the 1 p.m. dose was administered at 3:01 p.m. (two hours and one minute after it was due). The reason for the late administration was documented as medication not available. bb. October 21, 2016, Potassium Chloride 40 mEq to be given at 9 a.m. According to the eMAR: - On October 21, 2016, the 9 a.m. dose was administered at 3:56 p.m. (six hours and fifty six minutes after it was due). The reason for the late administration was documented as medication not available. M. The record for Patient 15 included the following medication orders: aa. October 14, 2016, Potassium Chloride 40 mEq to be given IV at 9:30 a.m. According to the eMAR: - On October 14, 2016, the 9:30 a.m. dose was administered at 12:46 p.m. ( three hours and sixteen minutes after it was due). The reason for the late administration was documented as medication not available. b. October 16, 2016, Potassium Chloride 40 mEq to be given IV at 10:42 a.m. According to the eMAR: - On October 16, 2016, the 10:42 dose was administered at 12:33 p.m. (one hour and fifty one minutes after it was due). The reason for the late administration was documented as medication not available. N. The record for Patient 17 included the following medication orders: aa. October 2, 2016, Nafcillin (an antibiotic) 2 grams to be given IV every four hours. According to the eMAR: - On October 2, 2016, the 5 p.m. dose was administered at 6:28 p.m. (one hour and twenty eight minutes after it was due). The reason for the late administration was documented as medication not available; - On October 6, 2016, the 5 a.m. dose was administered at 6:03 a.m. (one hour and three minutes after it was due). The reason for the late administration was documented as medication not available; and, - On October 10, 2016, the 9 a.m. dose was administered at 10:29 a.m. (one hour and twenty nine minutes after it was due). The reason for the late administration was documented as medication not available. O. The record of Patient 23 included the following medication orders: aa. November 9, 2016: Nystatin/Triamcinolone (treatment for skin infection) 15 grams to be applied twice a day. According to the eMAR: - On November 9, 2016, the 9 p.m. dose was not administered to the patient. The reason for the missed dose was documented as medication not available. bb. November 11, 2016: Tigecycline (an antibiotic) 50 milligrams to be given IV every 12 hours. According to the eMAR: - On November 11, 2016, the 5:08 p.m. dose was administered at 8:58 p.m. (three hours and fifty minutes after it was due). The reason for the late administration was documented as medication not available. P. The record for Patient 33 included a order dated October 13, 2016, for Ranolazine ER (heart medication - extended release) 500 milligrams by mouth twice a day. According to the eMAR: - On October 14, 2016, the 9 a.m. dose was administered at 10:53 a.m. (one hour and fifty three minutes after it was due). The reason for the late administration was documented as medication not available; - On October 15, 2016, the 9 a.m. dose was administered at 11:29 a.m. (two hours and twenty nine minutes after it was due). The reason for the late administration was documented as medication not available; and, - On October 17, 2016, the 9 a.m. dose was administered at 11:59 a.m. (two hours and fifty nine minutes after it was due). The reason for the late administration was documented as medication not available. Q. The record for Patient 34 included an order dated October 12, 2016, for Ceftriaxone (an antibiotic) two grams to be given IV (intravenously - into the vein) daily. According to the eMAR: - On October 13, 2016, the 9 a.m. dose was administered at 3:04 p.m. (six hours and four minutes after it was due). The reason for the late administration was documented as medication not available; - On October 14, 2016, the 9 a.m. dose was administered at 1:59 p.m. (four hours and fifty nine minutes after it was due). The reason for the late administration was documented as medication not available; - On October 15, 2016, the 9 a.m. dose was administered at 10:13 a.m. (one hour and thirteen minutes after it was due). The reason for the late administration was documented as medication not available, and; - On October 17, 2016, the 9 a.m. dose was not administered to the patient. The reason for the missed dose was documented as medication not available .called pharmacy twice still no atbx (antibiotic) sent by the end of shift. R. The record for Patient 35 included an order dated October 2, 2016, for Ceftriaxone (an antibiotic) two grams to be given IV daily. According to the eMAR: - On October 3, 2016, the 9 a.m. dose was administered at 11:35 a.m. (two hours and thirty five minutes after it was due). The reason for the late administration was documented as medication not available; and, - On October 4, 2016, the 9 a.m. dose was administered at 11:52 a.m. (two hours and fifty two minutes after it was due). The reason for the late administration was documented as medication not available. The facility policy titled, Medication Administration, was reviewed on November 16, 2016. According to the policy: a. Medications would be administered in compliance with hospital guidelines; b. Medications should be administered, exactly as ordered by the physician; and, c. Medications must be administered within 60 minutes before or after the scheduled administration time. The facility policy titled, Medication Errors, was reviewed on November 16, 2016. According to the policy: a. A medication error was defined as any preventable event that may cause or lead to inappropriate medication use or patient harm; b. Medication occurrences (errors) included medications given at the wrong time (one hour or more before or after the time it was due), and omitted doses (medication that was not administered as ordered); c. Such events (errors) may be related to systems and procedures, including medication administration; d. It was the responsibility of any licensed professional administering medications to report any .medication errors . promptly and accurately .and to contact the physician; and, e. All medication occurrences would be reviewed and trended through the Treatment and Surveillance Committee. According to American Society of Health-System Pharmacists (ASHP), a nationally recognized pharmacist organization, in its publication, ASHP Guidelines on Preventing Medication Errors in Hospitals, .Omission error: The failure to administer an ordered dose to a patient before the next scheduled dose, if any . Wrong time error: Administration of medication outside a predefined time interval from its scheduled . Pharmacy staff should review medications that are returned to the department. Such review processes may reveal system breakdowns or problems that resulted in medication errors (e.g., omitted doses and unauthorized drugs) . According to ASHP publication, ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals, Reviewing Patient Responses to Medication Therapy. Medication therapy monitoring shall be conducted by pharmacists. Medication therapy monitoring includes a proactive assessment of patient problems and an assessment of .Therapeutic duplication or omissions in the patient's medication regimen . Further review of the, Admin Variance October 2016, reports on November 16, 2016, indicated for the month of October 2016 (31 days): - Medications were given more than one hour past the time they were due a total of 616 times; and, - Medication doses were withheld by the nursing staff a total of 634 times. During an interview during the Quality Assessment Performance Improvement (QAPI) discussion on November 15, 2016, at 10 a.m., the Director of Pharmacy (DOP) stated late administration of medications and missed doses were not accurately reflected in the quarterly medication error reports, because only the errors reported using the Meditech incident reporting system were included. The DOP stated the pharmacy did not generate reports, look for trends, or identify the reasons for late medication administrations or missed doses to determine what corrective actions could be taken to prevent further errors. During a Quality Assessment and Performance Improvement (QAPI) interview with the Director of Pharmacy (DOP), the Chief Nursing Officer (CNO), the Assistant Chief Nursing Officer (ACNO), and the [NAME] President of Quality (VPQ) on November 16, 2016, at 10 a.m., the leaders stated they were aware the nurses in the Intensive Care Unit (ICU) were, frustrated, with the number of medications that were not available. The leaders stated they did not know the unavailability of medications, missed medications, and omitted doses were occurring throughout the facility. 2. [Crash carts, located at each nursing station, contain emergency medications and supplies for immediate treatment of life-threatening emergencies such as a heart attack]. a. During inspection of the Progressive Care Unit (PCU) on November 16, 2016, at 9:40 a.m., an adult crash cart was observed with the content list on top of the cart. Inspection of the cart revealed the medications on the list did not match the actual medications in the crash cart. The crash cart did not contain two injectable vials of vasopressin (a medication used to increase blood pressure during heart attack) 20 units/milliliter as indicated on the crash cart content list. In a concurrent interview, Pharmacy Technician (PT) 2 stated the list was old. b. During inspection of the Surgical Intensive Care Unit (ICU) Medication Room on November 16, 2016, at 10 a.m., one injectable vial of vasopressin 20 units/milliliter was observed inside the Pyxis (an automated dispensing cabinet for medications) refrigerator. The Pyxis inventory indicated there should have been three vasopressin vials instead of only one vial on hand. Review of the crash cart content list indicated there would be zero vials of vasopressin in the crash cart, and vasopressin would be located in the Pyxis refrigerator. In a concurrent interview, PT 1 acknowledged there was only one vasopressin vial in the refrigerator. c. During inspection of the Cardiac Catheterization Lab (CCL) room [ROOM NUMBER] on November 11, 2016, at 1 p.m., an adult crash cart was observed with the content list on top of the cart. The content list indicated two injectable vials of vasopressin 20 units/milliliter would be located inside the cart. Inspection of the cart revealed it did not contain any vasopressin inside. In a concurrent interview, Registered Nurse (RN) 2 stated there were five vasopressin vials in the Pyxis refrigerator. The facility policy and procedure titled, Emergency Carts Crash Carts last revised, April 2016, read, in part: All crash carts will be stocked in accordance with a supply list that addresses both contents and location of each item in order to assure uniform supplies and presentation in emergency situations . The contents of the container shall be listed on the outside cover . Adult Crash Cart Drug Tray Contents .vasopressin 20 units/1 ml (milliliter) VL (vial) 2 (two vials) . 3. During medication pass observation on November 16, 2016, at 8:30 a.m., a 5-ml (milliliter) bottle of atropine sulfate (an eye medication used to dilate pupil or decrease eye inflammation) 1% Ophthalmic (pertaining to eye) solution was observed on Patient 18's bedside tray in his room. Review of the patient's electronic medical record indicated there was a physician's order on November 14, 2016, for atropine sulfate eye drops, one drop in each eye, as needed for dry eye. In a concurrent interview, RN 3 confirmed there was no physician's order to keep atropine at the patient's bedside. The facility policy and procedure titled, Medication Administration last revised, August 2016, read, in part: Medications are not to be kept at the patient's bedside .

Violation Name: PHARMACIST SUPERVISION OF SERVICES(A-0501)

• Inspection Date: 2016-11-17 (Event ID: 5QTZ11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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25281 Based on observation, interview, and record review, the facility failed to ensure cleaning of the intravenous (IV) compounding area of the pharmacy was performed in accordance with the facility policy and procedure, and consistent with the federal United States Pharmacopeia (USP) <797> standards. Findings: [The USP convention is a scientific, nonprofit organization, that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed, and consumed worldwide. USP's drug standards are enforceable in the United States by the Food and Drug Administration. USP Chapter <797> provides procedures and requirements for compounding sterile preparations. General Chapter <797> describes conditions and practices to prevent harm to patients that could result from microbial contamination, excessive bacterial endotoxins, variability in intended strength, unintended chemical and physical contaminants, and ingredients of inappropriate quality in compounded sterile preparations]. The Pharmacy IV Compounding (mixing) Area with IV hoods (enclosed workbenches where compounding takes place) was inspected on November 15, 2016, at 2 p.m. Review of the monthly, Pharmacy Room Cleaning Log, for the hoods, during the last four months, indicated the daily hood cleaning was not performed consistently. In a concurrent interview, Registered Pharmacist (RPH) 1 stated the daily cleaning of the hood would take place by the pharmacy technician in the morning, before the morning shift started. RPH 1 acknowledged the cleaning of the IV hood was not consistently performed daily. The facility policy and procedure titled, Laminar Airflow Workbench-Cleaning and Maintenance dated, August 2014, read, in part: The inside of the hood must be cleaned at a minimum at the beginning of each shift, before each batch . The Pharmacy Director or designee shall be responsible for checking the hood cleaning logs daily to confirm that documentation of hood cleaning has been done per shift . According to USP <797>, Table 3, the Primary Engineering Control (e.g., IV laminar airflow hood) would need to be cleaned at a minimum, At the beginning of each shift, before each batch, not longer than 30 minutes following the previous surface disinfection when ongoing compounding activities are occurring, after spills, and when surface contamination is known or suspected .

Violation Name: PATIENT RIGHTS(A-0115)

• Inspection Date: 2015-02-26 (Event ID: OTPT11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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18918 Based on observation, interview, and record review, the facility failed to ensure Patient Rights were protected by: 1. Failing to ensure three sampled patients (Patients 404, 106, and 107) were provided the right to formulate advance directives and have hospital staff and practitioners who provided care in the hospital comply with those directives (A132); 2. Failing to ensure care was provided in a safe setting by ensuring involuntarily confined (5150) patients were under constant observation and admitted to environments that were designed (with adequate bathrooms and ability to regulate temperature), equipped (with bedside monitors, medications ordered for the patients, and bedside phones to order dietary preferences), and staffed (with nurses at the same ratios to provide the level of care they would receive on inpatient units) (A144); and 3. Failing to ensure one sampled patient's injury of unknown origin (potential abuse) was reported and investigated and the patient was protected from further abuse during an investigation (A145). The cumulative effect of these systemic problems resulted in failure of the facility to ensure patients rights were promoted and protected in a safe and effective manner.

Violation Name: PATIENT RIGHTS: INFORMED DECISION(A-0132)

• Inspection Date: 2015-02-26 (Event ID: OTPT11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** 31688 Based on interview and record review, the facility failed to obtain, communicate, or assist three sampled patients (Patients 404, 106, and 107) with advance directives. This failed practice resulted in the potential for delay and/or denial of the patient's right to make legal decisions, including their right to accept or refuse medical or surgical treatment, and the right to have written instruction, such as a living will or durable power of attorney for healthcare while hospitalized . (An advance directive is a written instruction, such as a living will or durable power of attorney for health care, that gives directions to the healthcare team, in advance, regarding procedures/treatments the patient wants or doesn't want to have done in the event they become incapacitated). Findings: 1. The electronic health record (EHR) was reviewed for Patient 404 on February 26, 2015. Patient 404 was admitted to the facility on [DATE]. Patient 404's admission diagnoses included altered level of consciousness, acute renal failure, and shortness of breath. The EHR nursing admission assessment indicated Patient 404's advance directive was documented as UNK or unknown. The EHR indicated if the nurse's response was N or U the nurse should explain the entry. There was no further documentation in the EHR which indicated an updated status for Patient 404's advance directive. Record review of Patient 404's chart indicated Patient 404 had an updated advance directive dated, January 27, 2015, signed by a surrogate decision maker. The form titled, Advance Healthcare Directive Preferred Intensity of Care Documentation, indicated, Resuscitate-no, Medication restriction-no, Treatment Restriction-no, Tube Feeding-yes, and Intravenous solutions-yes. An interview was conducted with the Medical Intensive Care Unit Manager (MICUM) on February 26, 2015, at 11:30 a.m. The MICUM stated that day, the status of patient (404's) advance directive was unclear. The MICUM stated, The nurse needs to clarify with the physician the advance directive of this patient. An interview was conducted with Patient 404's Nurse, Nurse 6, on February 26, 2015, at 11:15 a.m. Nurse 6 stated she did not have enough time to update the status of the advance directive in the EHR but she was aware of the written advance directive (located in the chart). Nurse 6 stated, We (nursing) need to clarify with the family (the advance directive). Record review of the facility policy titled, Advance Directive, dated with revision on January 2012, indicated, .Any person who becomes aware during the patient's hospitalization that the patient has formulated or revoked an Advance Directive(s) shall notify the patient's attending physician. The attending physician is responsible for the new information and updating the patient's treatment plan . The policy further indicated,If a patient is incapacitated at the time of admission, the hospital may give advance directive information to a family member or surrogate. If the patient is unaccompanied, information on advance directives and inquiry into the existence of an advance directive shall be directed to the patient's surrogate decision maker by the nursing staff responsible for the patient, once a surrogate decision maker has been identified by the attending physician with the assistance of social services. 22764 2. The electronic medical record (EMR) for Patient 106 was reviewed on February 24, 2015. Patient 106 was admitted to the facility on [DATE], with a diagnosis of left hip fracture requiring surgical correction. The advance directive (AD) section of the EMR, displaying previous and current admitting information, indicated the following: a. On November 27, 2014, she indicated she had not executed (completed) an advance directive; b. On January 19, 2015, Patient 106 indicated she had executed an advance directive. There was no evidence a copy was requested. There was no evidence a copy was placed in the chart. There was no information regarding her wishes according to her advance directive; c. On January 20, 2015, her daughter indicated she had executed an advance directive, and she wanted all life saving measures done if she suffered a cardiac or respiratory arrest. Her daughter was asked to provide a copy of the AD at 8:59 a.m., and the Case Management (CM) notes indicated Patient 106 had an AD on file at 11:30 a.m. There was no evidence a copy of the AD was placed in the chart. There was no information regarding her wishes according to her advance directive; and, d. On February 22, 2015, Patient 106 indicated she had executed an advance directive (AD) and was asked to provide a copy of it, but no copy was in the chart. There was no information regarding her wishes according to her advance directive. The paper chart for Patient 106 was reviewed on February 24, 2015. The record did not contain a copy of Patient 106's advance directive. During an interview with Registered Nurse (RN) 4 on February 24, 2015, at 4 p.m., the RN stated she did not know whether Patient 106 had an AD. RN 4 stated she had not asked the patient or checked in the EMR or the paper chart to see if there was an AD. She stated she could, look into it. During an interview with the [NAME] President of Quality (VPQ) on February 25, 2015, at 2:30 p.m., the VPQ stated when a patient was admitted , if they indicated they had executed an AD, the staff would request a copy of it. According to the VPQ, when a copy of the AD was received, it would be scanned into the computer, then placed into the paper chart. The VPQ stated the AD information would not be available for use on the next admit because, it might change. The facility policy titled, Advance Directive, was reviewed on February 25, 2015. According to the policy, if a patient indicated they had an AD, but did not bring a copy with them, they would be asked if they provided one on the previous admission, and a copy would be obtained from the medical record and placed on the current chart. When the copy was received on the unit, the nurse would have the AD reviewed by the patient or their surrogate and verify if it still reflected the patient's wishes. 3. The electronic medical record (EMR) for Patient 107 was reviewed on February 25, 2015. Patient 107 was being seen in the Radiation Oncology Clinic for treatment of lung cancer. The advance directive (AD) section of the EMR indicated Patient 107 had executed (completed) an AD, and there was a copy in the chart. No copy was located after searching the EMR. There was no information regarding the contents of the AD or the patient's wishes according to the AD in the EMR. The paper chart for Patient 107 was reviewed on February 25, 2015. The paper chart contained a copy of the AD executed by Patient 107 that indicated she did not want to be kept on life support if she suffered from an irreversible condition and could only be kept alive with the use of life support. During an interview with the Radiation Oncology Administrative Assistant (AA) on February 25, 2015, at 8:10 a.m., the AA stated she asked every patient she registered to receive services at the clinic, if they executed an AD. The AA stated if the patient told her they had executed an AD, she asked them for a copy, and placed the copy in the paper chart. The AA stated the EMR could be accessed from the clinic or from the hospital, and the people in the hospital could see that Patient 107 had executed an AD, but they could not see what the patient's wishes were according to the AD because the copy was located in the paper record inside the clinic. The facility policy titled, Advance Directive, was reviewed on February 25, 2015. According to the policy, all adult inpatients and outpatients would be queried about whether or not they had an advance directive, and would be asked to provide a copy if they had one, but they would be informed that if they had an AD, it would not be honored.

Violation Name: PATIENT RIGHTS: CARE IN SAFE SETTING(A-0144)

• Inspection Date: 2015-02-26 (Event ID: OTPT11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** 22764 Based on observation, interview, and record review, the facility failed to ensure: 1. A Certified Nursing Assistant (CNA) prevented one 5150 patient (Patient 102) from locking herself in the bathroom each time she used it, resulting in the potential for a suicide attempt, harm, or death to the patient; 2. A security officer working for a contracted security service received training on monitoring of 5150 (involuntarily confined) patients before he was assigned to do so, resulting in the potential for psychiatric patients with suicidal or homicidal tendencies to injure themselves, other patients, visitors, or staff; (A 5150 patient is a patient who has been involuntarily confined by a peace officer or qualified clinician because they are suspected to have a mental disorder that makes them a danger to themselves, a danger to others, or gravely disabled. Patients who are a danger to themselves must remain in an environment that prevents them from getting to objects that they may use to cause self harm. Patients who are a danger to others must remain in a calm environment where visitors and outside stimulation are monitored and controlled to prevent escalation of behavior and threat or injury to others); and, 3. Four patients (Patients 109, 110, 111, and 204) were admitted to appropriate environments that were designed (with adequate bathrooms and ability to regulate temperature), equipped (with bedside monitors, medications that had been ordered for the patients, and bedside phones to order dietary preferences), and staffed (with the same nurses at the same ratios to provide the level of care they would receive on inpatient units) to promote quality of care, comfort, and dignity of the patients, resulting in the potential for emotional and physical harm to the patients. Findings: During a tour of the Emergency Department (ED) on February 24, 2015, at 11 a.m., the following was observed: 1. A certified nursing assistant (CNA) was standing outside of room M (a room that had a 5150 patient in it). During an interview with the CNA on February 24, 2015, at 11:05 a.m., the CNA stated the patient in the room (Patient 102) was there on a 5150 because she tried to drown herself. When asked how the patient used the bathroom (a female patient with a male CNA), he pointed to a bathroom door at the end of the hallway, and stated he walked to the door with her and waited outside of the door while she went to the bathroom. The CNA stated the patient was able to lock the door while she was in the bathroom. He stated at times a female would go into the bathroom with the patient, but not always. He stated if she locked herself in and he was concerned about her, or she would not or did not come out, he would call security. He stated she could hurt herself in there, but that was the reason he stood by the door. 2. A security officer was sitting in a chair outside of room N (a room that had a 5150 patient in it). Activity was observed taking place down the hall (approximately 100 feet away) involving a patient laying on the ground and screaming. The officer left the doorway of the 5150 patient to check on the activity down the hall. As he walked away, the officer said to a male employee that was nearby, Will you watch him? He walked away without waiting for a response from the other male employee, or telling the other male employee anything about the 5150 patient. During an interview with the officer on February 24, 2015, at 11:10 a.m., the officer stated he was, watching, a 5150 patient who hit a wall with his fist. The officer stated he did not know what the 5150 was issued for (a danger to himself or a danger to others), but, I would go with a danger to self since he hit a wall. The officer stated it would not matter if the patient was being held as a danger to himself or a danger to others, because he would, just watch him and react accordingly. The employee file for the security officer was reviewed on February 26, 2015. There was no evidence in the file the security officer was trained or demonstrated competency in monitoring/sitting with 5150 patients. During an interview with the Manager of Public Safety on February 26, 2015, at 11:20 a.m., the manager stated there was no specific training done for the security officers regarding monitoring/sitting with 5150 patients. 3. A review of the facility census on February 24, 2015, indicated there were 267 admitted patients with 249 licensed general acute care beds. admitted patients were located in the medical surgical/telemetry/cardiovascular (general acute care) units, as well as 25 admitted patients in the Emergency Department (ED), 14 admitted patients in the Outpatient Surgery/Observation Unit, and four adult patients admitted to the Pediatric Unit. During a facility tour on February 25, 2015, at 10:50 a.m., a sign on the wall in the hallway indicated the facility had a newly labeled, Observation Unit (OBS). Upon entering the unit, it was observed to be an aisle with a door to the main hallway at one end, and a nurse's station at the other end. Beds lined the walls on both sides of the aisle, separated by privacy curtains, 15 beds in total. The lights in the unit were on, all controlled by one switch so they could never be turned off for patients to have darkness for sleep. There were no bedside telephones for patients to make phone calls, including calls to the dietary department to report their meal choices. A sign on the wall in the nurse's station read,Call daily for breakfast, lunch, and dinner. During the tour of the OBS Unit, two patients, one male and one female, were observed wearing hospital gowns, while walking from their curtained beds, to the unit's bathrooms. The patient bathrooms were located in the same unit, but around the corner and about 40 feet from the bed at the end of the hall. There were two bathrooms total, one male bathroom and one female bathroom, to be shared between the 15 patients. There were no showers available for patients to use. Further observation revealed there were no bedside monitors, and a sign on the wall in the nurse's station read, Please call tele room to verify patient can be seen on monitor and get rhythm. During a concurrent interview with the Manager of the Observation and Cardiovascular Units, the manager stated the unit was licensed as an outpatient surgery unit, but was now used for admitting observation patients. She stated there were 14 patients in the unit with 15 beds. She stated the unit was staffed,mostly, with float nurses or travelers, at a medical surgical or telemetry ratio. According to the manager, there were currently four registered nurses (RNs) working in the unit. The manager stated patients admitted to the unit should have an expected length of stay of greater than six hours, but they should not be there for more than 24 hours. The manager stated there were four patients in the unit who had been there for two days (Patients 109, 110, 111, and 113), and she did not know who authorized their admission to the unit. The manager stated they were not observation patients, they were higher acuity patients who required inpatient care. A review of the census indicated 10 patients were admitted to the unit on February 24, 2015, (the previous day), and four patients were admitted to the unit on February 23, 2015 (two days earlier). Record reviews were conducted and indicated the following: a. Patient 109 presented to the Emergency Department (ED) on February 23, 2015, with complaints of right sided headaches and weakness for the past few days. She had a history of thyroid disease and hypertension (HTN - high blood pressure). Her heart rate in the ED was 129 (normal 60-100). According to the ED physician's report, she was admitted to the facility at the request of her primary care physician due to concerns about her fast heart rate and headaches associated with right arm weakness (signs of a possible stroke). The admitting history and physical (H&P) indicated the patient had a history of HTN, hypothyroidism (low thyroid functioning), and anxiety, and had been having severe headaches associated with right sided numbness and blurred vision for three days. Patient 109 was admitted to the observation unit with diagnoses that included severe headaches (complex migraines versus other pathology [abnormality], HTN, hypothyroidism, and anxiety. The plan included treatment of the headaches with oral and intravenous pain medications, a neurology consult, blood pressure medications, thyroid labs and medications, medication for anxiety, medication to decrease the acid content in the stomach caused by stress, and medication to prevent development of clots in the legs caused by prolonged time in the bed. She was still in the unit two days later. b. Patient 110 was accepted as a transfer to the facility (at a time when the facility had no empty general acute care beds available) from a different facility on February 23, 2015, after being treated there for complaints of Bell's Palsy (paralysis of one side of the face) and feeling like his heart was skipping a beat. The examination at the other facility indicated Patient 110 had bradycardia (a slow heart rate) and an elevated troponin level (a lab value that is indicative of injury to the heart muscle). The ED physician's record indicated his heart rate was 57 and 52 respectively (normal 60-100), his electrocardiogram (EKG) showed changes in the inferior wall of his heart that was indicative of possible damage to the heart muscle, and his care was being transitioned to inpatient service for further evaluation and care. The admitting H&P indicated he was being admitted for observation for acute coronary syndrome and placed on telemetry, an echocardiogram would be ordered, and a consult would be done with a cardiologist. According to the record, Patient 110 had a lexiscan procedure (intravenous (IV) cardiac and nuclear medication injection with a heart scan to determine if reversible damage has occurred in the heart muscle) done on February 24, 2015 (the day after he was admitted to the observation unit), that showed reversible damage to the heart muscle with abnormal pumping of the heart. He was sent back to the observation unit following the test, and scheduled to have a cardiac catheterization (injecting contrast into the coronary arteries and the left ventricle to assess the blood flow to the heart and the pumping function of the ventricle) the following day. He was still in the unit two days later. A review of the census on February 26, 2015, indicated Patient 110 was still in the observation unit (three days after admission). c. Patient 111 presented to the ED on February 23, 2015, complaining of feeling dizzy and unsteady on his feet for one day, with diplopia (double vision). The ED physician's report indicated the patient had a history of diabetes and HTN, and the computerized axial tomography (CT) scan of his brain showed a one centimeter area of concern that appeared as if there was blood in the brain. The record indicated Patient 111 was being transitioned to the inpatient service for further care. The admitting H&P indicated Patient 111 was admitted to the observation unit with a diagnosis of intracerebral hemmorhage (bleeding into the brain), with a plan to obtain a magnetic resonance imaging (MRI) of his brain and a neuro (neurology/neurosurgery) consult. He was still in the unit two days later. A review of the census on February 26, 2015, indicated Patient 111 was still in the observation unit (three days after admission). d. Patient 204 was accepted as a transfer to the facility (at at time the facility had no empty general acute care beds available) from a different facility on February 24, 2015, at 9:02 a.m., due to Non-ST elevation myocardial infarction (heart attack) and pneumonia. Physician's orders for Patient 204 included telemetry (heart monitoring) and vital signs every 2 hours. Patient 204 was also receiving the antibiotic Zosysn every eight hours to treat pneumonia (infection of the lungs). The admitting H&P indicated Patient 204 was being admitted for coronary angiography (injecting contrast into the coronary arteries and the left ventricle to assess the blood flow to the heart and the pumping function of the ventricle). According to the record, Patient 204 was admitted to the observation unit at 9:02 a.m., and was transferred to the cath lab at 3:10 p.m. Patient 204 was sent back to the observation unit, on February 24, 2015, at 4:40 p.m. Patient 204's angiogram findings indicated the patient had significant blockage and the physician would be discussing coronary angioplasty (minimally invasive procedure to open blocked arteries) or bypass graft (open heart surgery) with the patient's son. Patient 204 remained in the observation unit until February 25, 2015, at 2:30 p.m., when she was transferred to the cardiovascular unit (29 hours and 28 minutes after she was admitted to the observation unit). During a tour of the telemetry room on February 25, 2015, at 11:30 a.m., three monitor technicians (MTs) were observed sitting in a room with three banks of telemetry monitoring screens. During a concurrent interview with MT 1, the MT stated each of them was responsible for monitoring up to 48 heart rhythms, and the total number of patients that could be monitored in the room was 144. The MT stated they did not know the baseline rhythms for all of the patients they were monitoring, and would not necessarily know when a patient's rhythm changed unless it was a, dangerous, rhythm. He stated they were monitoring for and reporting, dangerous, rhythms only. MT 1 had the patients in the Observation unit in his bank of monitors, and stated he saw only 11 observation patient rhythms, not 14. The rhythm for Patient 110 was observed to be a normal sinus rhythm with frequent premature atrial contractions (PACs) (a usually benign, early beat of the heart that can be described by the patient as a skipped beat or a jolt in the chest - as Patient 111 had complained of). On February 26, 2015, at 9:30 a.m., RN 3 was observed providing care in the Observation Unit. RN 3 stated she had to get Patient 206's medication from the pharmacy as it was not in the unit. During an interview with the Observation Unit Manager, on February 26, 2015, at 10:10 a.m., the Manager stated they did not have a pyxis refrigerator in the unit, so they had to obtain medications from the pharmacy. In addition, the Manager stated as the patient's were transient (short stay or transfers), daily medications were not sent to the unit. The Manager stated the patient's nurse would call the pharmacy about an hour before the patient's medication was due, to receive the medication. During an observation of the OBS unit on February 26, 2015, between 9:30 and 10:15 a.m., there were 15 patients in the unit with each privacy curtain closed around the respective bed. A [AGE] year old female, admitted the previous day for complaints of chest pain, was heard yelling through the curtain, it's hot in here. Staff opened the curtains, and exposed the patient to the other patients, staff, and visitors in the unit. The facility policy titled, Plan for the Provision of Patient Care - Scope of Service, was reviewed on February 26, 2015. The policy indicated the following: A. The observation unit was used to care for patients requiring further management, specifically to determine the need for inpatient admission, who met criteria for medical, surgical, and telemetry level of care up to a 24 hour stay; B. The observation unit was for patients where diagnosis, treatment, stabilization, and discharge could reasonably be expected within 24 hours; C. Acceptable diagnoses for the Observation unit included diagnoses such as non-specific chest pain (chest pain without an identified cause), anemia, non-titrated IV medications (not needing to increase and decrease rates to manage symptoms), cardiac arrhythmias (abnormal heart rhythms), elective angiograms, interventional radiology procedures, and same day surgery; D. Acceptable diagnoses for the Cardiovascular unit (CVU) included acute myocardial infarction (heart attack) (the diagnosis Patient 204 had), cardiac dysrhythmias (abnormal heart rhythms), and stroke (the type of diagnoses Patients 109 and 111 had). Staffing in the unit was one nurse for every three patients, and the nursing staff provided continuous cardiac monitoring; and, E. The Progressive Care Unit (PCU) was for patients who were stable with the potential for becoming unstable. Acceptable diagnoses for the PCU included stable myocardial infarction and acute coronary syndrome (the diagnosis Patient 110 had). Staffing in the unit was one nurse for every three patients, and the nursing staff provided continuous cardiac monitoring. During an interview with the [NAME] President (VPQ) of Quality on February 25, 2015, at 2:30 p.m., the VP stated Patients 109, 110, 111, and 204 should have been admitted to the inpatient areas, but there were no rooms available for them.

Violation Name: PATIENT RIGHTS: FREE FROM ABUSE/HARASSMENT(A-0145)

• Inspection Date: 2015-02-26 (Event ID: OTPT11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** 18918 Based on interview and record review, the facility failed for one sampled patient (Patient 208) to follow their policy and procedure titled, Abuse Assessment and Reporting, after staff reported a new onset of vaginal/groin bruising to Patient 208. Facility staff failed to report the injury to the Risk Manager, and the Social Services personnel failed to report the incident to the appropriate entities. In addition, the facility failed to follow their policy and procedure titled, Assault Abuse within the Hospital, by failing to conduct an investigation, as soon as possible after Patient 208 was observed with a new onset of vaginal/groin bruising. This failure resulted in a delay in determining the cause of Patient 208's bruising and the failure to protect Patient 208 from further injury. Findings: On February 5, 2015, APS (Adult Protective Services) sent a Report of Suspected Dependent Adult/Elder Abuse, to the California Department of Public Health. The report indicated it was completed on February 5, 2015, at 9:27 a.m. The report indicated Patient 208 was a victim and suspected abuser, was unknown. The following was documented: RP (Reporting Party) is hospital SW (Social Worker) reporting that client (Patient 208) was admitted on [DATE] .RP said that sometime after that the CNA (Certified Nurse Assistant) noticed some bruising around client's vaginal area .RP said as far as known, this incident was not reported to law enforcement, APS or any other agency and no pictures were taken of the bruising .Client was discharged from the hospital on February 3, 2015 . On February 12, 2015, at 2:40 p.m., SW 1 was interviewed. SW 1 stated on February 2, 2015, she received a call from a case manager about a possible APS (Adult Protective Services) Case. SW 1 stated the facility had identified medical changes to Patient 208 that could be abuse related. SW 1 stated she instructed staff how to contact APS and to complete paperwork. SW 1 stated, when she returned to work on February 5, 2015, she followed up with unit staff and found the incident had not been reported to APS. SW 1 stated she notified APS on February 5, 2015 (three days after the initial report). The facility's policy and procedure titled, Abuse Assessment and Reporting, with a last revised date of March 2013, was reviewed. The policy indicated: a. It applied to all hospital and medical staff practitioners; b. Staff who have knowledge of suspected cases of abuse/neglect of the elderly or dependent adults will report to the proper authorities; c. For adult abuse/neglect-reports should made as soon as possible by telephone to the (county of residence of the victim) Adult Protective Services (APS); d. Hospital personnel must complete the required abuse reporting forms, with the original being attached to the patient's record; e. Depending upon the severity of the injuries of the possible victim, APS may also recommend Law enforcement be notified; f. The patient's medical record documentation should include all pertinent observations; (i.e., physical injuries, patient and family behavior during visits), and all actions taken by staff; g. Indicators of possible sexual abuse included bruises or bleeding in external genitalia; and h. Documentation shall be completed in the medical record reflecting the initial concern and the agency contact information where the report was filed. This will include the name, contact person, phone number, date and time of the report, and the outcome expected (i.e. whether agency staff will be coming to the hospital to see the patient, any time frames given by the agency intervention). A review of Patient 208's record was conducted on February 24, 2015. Patient 208 was admitted to the facility on [DATE], with diagnosis that included urinary tract infection (UTI). Patient 208's History and Physical (H&P), indicated the patient was an [AGE] year old female, with a history of frequent urinary tract infections. According to the H&P, Patient 208 suffered from dementia, anxiety and depression and became more confused when she had an UTI. The following notes were documented in Patient 208's record: February 1, 2015, at 3:33 a.m., Pt family visited, updated on POC (plan of care) .skin kept c/d/i (Clean, dry and intact) turned q2h (every 2 hours) and PRN (as needed) . February 3, 2015, at 5:42 p.m., MD visited Pt and spoke to pt's son .Pt repositioned q2 hrs . February 3, 2015, at 9:36 a.m., .Pt (patient) with back bruises .Pt non verbal but groaning, Social Worker involved with Pt . February 4, 2015, at 7:04 a.m., .Bruises noted to Groin and Bilat (Bilateral) hip bone Green/Purple-incont (incontinent) of urine-Pt cleaned before transport-Pt only moans in response to movement . On February 5, 2015, at 7:19 p.m., the RN who had been caring for Patient 208 on February 2, 2015, documented the following: Late Entry, Monday 2/2/15: 1800 (6 p.m.) Pt found this morning with dark ecchymosis at left inner thigh, radiating to pt vagina by CNA (Certified Nursing Assistant) .CNA stated that she had the same patient last week and pt did not have any ecchymosis in that area. Called MD (physician) .in AM, MD stated not to give Lovenox (blood thinner) if ordered and he will come by in the afternoon to see patient. Reported new bruise to Social Worker .Advised CNA to fill out APS (Adult Protective Services) worksheet and explain her concerns. MD arrived in afternoon, reported to Dr .about the ecchymosis, .MD glanced over Pt and sat down in nursing station, .Stated 'I wouldn't worry about it.' Pt was in no distress, vitals stable. Patient 208's electronic medical record had documentation of the patient's assessments in the Meditech, system. On February 1, 2015, at 8 p.m., the nurse documented bruising to the patient's left groin and hip. On February 2, 2015, at 5:22 p.m., the nurse documented bruising to the patient's left groin and hip. A review of the Case Management Report, revealed an entry dated February 5, 2015, at 10:17 a.m. The entry indicated it was a Social Worker (SW) note for February 2, 2015. The SW indicated she had received a call from the case manager about a possible APS referral. The SW spoke with the patient's nurse who reported CNA had observed medical changes in pt that could be abuse related. The SW provided contact information and education to CNA on how to fill out APS form. According to the documentation by the SW, the CNA was unable to fill out the form at that time and reported she (the CNA) would follow up with call to APS. On February 5, 2015, at 10:23 a.m., the SW documented Filed APS report .spoke with intake specialist . The Report of Suspected Dependent Adult/Elder Abuse, form completed on February 5, 2015, was reviewed. The form indicated Patient 208 was in an acute care hospital and prior to February 2, 2015, the patient may have been physically assaulted. According to documentation, CNA and RN (Registered Nurse) reported pt has bruises around vaginal area that was not present on Friday 1/20/15 . An interview was conducted CNA 1, on February 24, 2015, 2:45 p.m. CNA 1 stated she was providing care for Patient 208, on February 2, 2015, when she asked family members to step outside while she was bathing the patient. CNA 1 stated family members were reluctant to go outside, but eventually did. CNA 1 stated while changing Patient 208, she observed bruising to the patient's groin area. CNA 1 stated she did not know what caused the patient's bruising, but prior to February 2, 2015, Patient 208's skin was perfect, she did not have any bruising. CNA 1 stated she immediately informed the patient's nurse, about the bruising and about the visitors behavior. CNA 1 stated the nurse evaluated the patient's condition and contacted the charge nurse and the facility's Social Worker. CNA 1 stated she helped position the patient when photographs were taken. CNA 1 stated the SW explained to her (the CNA) that she was a mandated reporter and the APS paperwork would need to be completed. CNA 1 stated she did not have time to complete the document on February 2, 2015, and she did not complete the form prior to leaving for the day. An interview was conducted with D2 Manager (Manager), on February 24, 2015, at 3:15 p.m. The Manager stated when CNA 1 called her, she immediately went to Patient 208's bedside. The Manager stated it did not look like the patient had been battered, it looked like she had a bleed and it had migrated when the patient was lying on her side. The Manager stated the SW was called but we did not call the Risk Manager. On February 24, 2015, at 3;45 p.m., the Director of D2/Transplant was interviewed. The Director stated staff reported the incident to the Social Worker and the Director believed the SW would report the incident as needed. The Director stated the abuse policy did not get specific as to time frame for reporting, but she would expect an allegation of abuse to be reported the same day. The Director stated staff were unaware the Risk Manager (RM) needed to be notified about the incident. The Director stated the RM was eventually contacted and did interview some of the assigned staff. An interview was conducted with the Risk Manager (RM) on February 25, 2015, at 1:30 p.m. The RM stated she was not immediately notified about Patient 208's new onset of bruising. The RM stated she was notified by the CN on February 5, 2015, three days after the incident and two days after the patient was discharged to a Board and Care. The RM stated she needed to be notified immediately, as she needed to begin interviewing staff and visitors, to ensure the patient's safety. The RM stated the delay in notifying her, delayed the investigation. The RM stated if the injuries were as a result of abuse, she would contact law enforcement, but after speaking with Manager, they did not believe the injuries were a result of abuse. The RM stated she began to interview staff on February 5, 2015. The RM stated one CNA interviewed indicated there was no care rendered that would cause that type of bruising. Patient 208's record was re-reviewed. There was no photographic evidence of Patient 208's bruising. On February 26, 2015, at 10:40 a.m., an interview was conducted with the D2 Manager. The Manager stated she spoke with Patient 208's registered nurse (RN), who stated she never thought the patient's injury was due to abuse. A review of the training module completed by the facility employees on an annual basis included a section titled Rapid Regulatory Compliance: Clinical: Part 1. The training module included the following: a. Patient Assault and Abuse: Protecting Patients: to help protect patient from assault: be aware of the warning signs of abuse; b. Identifying and Assessing Victims of Abuse and Neglect- As a healthcare provider, you are in a unique position to identify victims of abuse; c. With regard to victims of abuse and neglect, The Joint Commission requires that accredited facilities: Identify victims of abuse or neglect; Educate healthcare staff; Assess and refer victims to available resources and report abuse and neglect. The facility policy and procedure titled, Assault Abuse within the Hospital, with an originated date of April 2011, indicated patients had the right to be free from abuse or any mistreatment by anyone, including, but not limited to, staff, other patients, consultants, volunteers, staff of other agencies serving the patient, family members, legal guardians, friends or other individuals. Procedures included: a. The hospital will conduct an investigation in a confidential manner as soon as possible, consistent with the needs of the situation. The investigation will include the person(s) who have potential knowledge of the situation; b. Any allegation of abuse, assault/battery will be immediately reported to the Director of Risk Management; c. Conduct a thorough investigation into the allegations; d. Maintain a record of the allegation, results of the investigation, and any corrective action taken; and e. Risk Management will keep investigation documentation as it related to the patient's allegation and investigation. After being notified by CNA 1, that Patient 208 had injuries that could be indicative of abuse, the RN and Social Worker, failed to notify the facility Risk Manager, APS, and/or Law Enforcement, and concluded without investigation that no further intervention and patient protection was required.

Violation Name: QAPI(A-0263)

• Inspection Date: 2015-02-26 (Event ID: OTPT11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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22764 Based on observation, interview, and record review, the facility failed to: 1. Develop, measure, analyze, and track quality indicator data from their newly developed observation unit (where patients with multiple diagnoses and needs were being admitted ) to determine the appropriateness of admission and delivery of safe and effective care. This failed practice resulted in admissions to the unit that were not consistent with the expected diagnoses and length of stay, and the potential for lack of safe and effective services (nursing, dietary, pharmacy, patient rights) (A273); 2. Ensure a monitoring system was in place to assure patients were opiod tolerant prior to receiving fentanyl transdermal patches for pain control, resulting in the potential for respiratory arrest and death in patients (A273); 3. Ensure actions were taken to prevent further medication errors after an investigation into a medication error resulting in cardiac arrest was carried out, and necessary preventative actions were identified, resulting in the potential for further medication errors that could lead to patient harm or death (A286); and, 4. Ensure an adverse event related to failure to medicate a patient as ordered, and a subsequent fall resulting in a fatal head injury, was appropriately investigated and analyzed, and preventative actions were planned and implemented, resulting in the potential for further medication errors that could lead to patient harm or death (A286). The cumulative effect of these systemic problems resulted in failure to ensure an effective quality assessment and performance improvement program, focused on prevention of errors and adverse outcomes, and improvement of processes, was implemented and maintained.

Violation Name: DATA COLLECTION & ANALYSIS(A-0273)

• Inspection Date: 2015-02-26 (Event ID: OTPT11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** 22764 Based on observation, interview, and record review, the facility failed: 1. To develop, measure, analyze, and track quality indicator data from their newly developed observation unit (where patients with multiple diagnoses and needs were being admitted ) to determine the appropriateness of admission and delivery of safe and effective care. This failed practice resulted in admissions to the unit that were not consistent with the expected diagnoses and length of stay, and the potential for lack of safe and effective services (nursing, dietary, pharmacy, patient rights); and, 2. To ensure a monitoring system was in place to assure patients were opiod tolerant prior to receiving fentanyl transdermal patches for pain control, resulting in the potential for respiratory arrest and death in patients. Findings: 1. The Performance Improvement and Patient Safety Plan, with an approval date of September 2014, was reviewed on February 24, 2015. The plan indicated performance expectations and measurements would be identified and established during the design of a new system, process, or service. A review of the facility census on February 24, 2015, indicated there were 267 admitted patients with 249 licensed general acute care beds. admitted patients were located in the medical surgical/telemetry/cardiovascular (general acute care) units, as well as 25 admitted patients in the Emergency Department (ED), 14 admitted patients in the Outpatient Surgery/Observation Unit, and four adult patients admitted to the Pediatric Unit. During a facility tour on February 25, 2015, at 10:50 a.m., a sign on the wall in the hallway indicated the facility had a newly labeled, Observation Unit (OBS). Upon entering the unit, it was observed to be an aisle with a door to the main hallway at one end, and a nurse's station at the other end. Beds lined the walls on both sides of the aisle, separated by privacy curtains, 15 beds in total. The lights in the unit were on, all controlled by one switch so they could never be turned off for patients to have darkness for sleep. There were no bedside telephones for patients to make phone calls, including to the dietary department to report their meal choices. A sign on the wall in the nurse's station read,Call daily for breakfast, lunch, and dinner. During the tour of the OBS Unit, two patients, one male and one female, were observed wearing hospital gowns, while walking from their curtained beds, to the unit's bathrooms. The patient bathrooms were located in the same unit, but around the corner and about 40 feet from the bed at the end of the hall. There were two bathrooms total, one male bathroom and one female bathroom, to be shared between the 15 patients. There were no showers available for patients to use. Further observation revealed there were no bedside monitors, and a sign on the wall in the nurse's station read, Please call tele room to verify patient can be seen on monitor and get rhythm. During a concurrent interview with the Manager of the Observation and Cardiovascular Units, the manager stated the unit was licensed for outpatient surgery patients, but was now used for admitting observation patients. She stated there were 14 patients in the unit with 15 beds. She stated the unit was staffed,mostly, with float nurses or travelers, at a medical surgical or telemetry ratio. According to the manager, there were currently four registered nurses (RNs) working in the unit. The manager stated patients admitted to the unit should have an expected length of stay of greater than six hours, but they should not be there for more than 24 hours. The manager stated there were four patients in the unit who had been there for two days (Patients 109, 110, 111, and 113), and she did not know who authorized their admission to the unit. The manager stated they were not observation patients, they were higher acuity patients who required inpatient care. A review of the census indicated 10 patients were admitted to the unit on February 24, 2015, (the previous day), and four patients were admitted to the unit on February 23, 2015 (two days earlier). Record reviews were conducted and indicated the following: a. Patient 109 presented to the Emergency Department (ED) on February 23, 2015, with complaints of right sided headaches and weakness for the past few days. She had a history of thyroid disease and hypertension (HTN - high blood pressure). Her heart rate in the ED was 129 (normal 60-100). According to the ED physician's report, she was admitted to the facility at the request of her primary care physician due to concerns about her fast heart rate and headaches associated with right arm weakness (signs of a possible stroke). The admitting history and physical (H&P) indicated the patient had a history of HTN, hypothyroidism (low thyroid functioning), and anxiety, and had been having severe headaches associated with right sided numbness and blurred vision for three days. Patient 109 was admitted to the observation unit with diagnoses that included severe headaches (complex migraines versus other pathology [abnormality], HTN, hypothyroidism, and anxiety. The plan included treatment of the headaches with oral and intravenous pain medications, a neurology consult, blood pressure medications, thyroid labs and medications, medication for anxiety, medication to decrease the acid content in the stomach caused by stress, and medication to prevent development of clots in the legs caused by prolonged time in the bed. She was still in the unit two days later. b. Patient 110 was accepted as a transfer to the facility (at at time when the facility had no empty general acute care beds available) from a different facility on February 23, 2015, after being treated there for complaints of Bell's Palsy (paralysis of one side of the face) and feeling like his heart was skipping a beat. The examination at the other facility indicated Patient 110 had bradycardia (a slow heart rate) and an elevated troponin level (a lab value that is indicative of injury to the heart muscle). The ED physician's record indicated his heart rate was 57 and 52 respectively (normal 60-100), his electrocardiogram (EKG) showed changes in the inferior wall of his heart that was indicative of possible damage to the heart muscle, and his care was being transitioned to inpatient service for further evaluation and care. The admitting H&P indicated he was being admitted for observation for acute coronary syndrome and placed on telemetry, an echocardiogram would be ordered, and a consult would be done with a cardiologist. Patient 110 had a lexiscan procedure (intravenous (IV) cardiac and nuclear medication injection with a heart scan to determine if reversible damage has occurred in the heart muscle) done on February 24, 2015 (the day after he was admitted to the observation unit), that showed reversible damage to the heart muscle with abnormal pumping of the heart. He was sent back to the observation unit following the test, and scheduled to have a cardiac catheterization (injecting contrast into the coronary arteries and the left ventricle to assess the blood flow to the heart and the pumping function of the ventricle) the following day. He was still in the unit two days later. A review of the census on February 26, 2015, indicated Patient 110 was still in the observation unit (three days after admission). c. Patient 111 presented to the ED on February 23, 2015, complaining of feeling dizzy and unsteady on his feet for one day, with diplopia (double vision). The ED physician's report indicated the patient had a history of diabetes and HTN, and the computerized axial tomography (CT) scan of his brain showed a one centimeter area of concern that appeared as if there was blood in the brain. The record indicated Patient 111 was being transitioned to the inpatient service for further care. The admitting H&P indicated Patient 111 was admitted to the observation unit with a diagnosis of intracerebral hemmorhage (bleeding into the brain), with a plan to obtain a magnetic resonance imaging (MRI) of his brain and a neuro (neurology/neurosurgery) consult. He was still in the unit two days later. A review of the census on February 26, 2015, indicated Patient 111 was still in the observation unit (three days after admission). d. Patient 204 was accepted as a transfer to the facility (with no empty general acute care beds available) from a different facility on February 24, 2015, at 9:02 a.m., due to Non-ST elevation myocardial infarction (heart attack) and pneumonia. Physician's orders for Patient 204 included telemetry (heart monitoring) and vital signs every 2 hours. Patient 204 was also receiving the antibiotic Zosysn every eight hours to treat pneumonia (infection of the lungs). The admitting H&P indicated Patient 204 was being admitted for coronary angiography (injecting contrast into the coronary arteries and the left ventricle to assess the blood flow to the heart and the pumping function of the ventricle). Patient 204 was admitted to the observation unit at 9:02 a.m., and was transferred to the cath lab at 3:10 p.m. Patient 204 was sent back to the observation unit, on February 24, 2015, at 4:40 p.m. Patient 204's angiogram findings indicated the patient had significant blockage and the physician would be discussing coronary angioplasty (minimally invasive procedure to open blocked arteries) or bypass graft (open heart surgery) with the patient's son. Patient 204 remained in the observation unit until February 25, 2015, at 2:30 p.m., when she was transferred to the cardiovascular unit (29 hours and 28 minutes after she was admitted to the observation unit). During a tour of the telemetry room on February 25, 2015, at 11:30 a.m., three monitor technicians (MTs) were observed sitting in a room with three banks of telemetry monitoring screens. During a concurrent interview with MT 1, the MT stated each of them was responsible for monitoring up to 48 heart rhythms, and the total number of patients that could be monitored in the room was 144. The MT stated they did not know the baseline rhythms for all of the patients they were monitoring, and would not necessarily know when a patient's rhythm changed unless it was a dangerous rhythm. He stated they were monitoring for and reporting dangerous rhythms only. MT 1 had the patients in the Observation unit in his bank of monitors, and stated he saw only 11 observation patient rhythms, not 14. The rhythm for Patient 110 was observed to be a normal sinus rhythm with frequent premature atrial contractions (PACs) (a usually benign, early beat of the heart that can be described by the patient as a skipped beat or a jolt in the chest - as Patient 111 complained of). On February 26, 2015, at 9:30 a.m., RN 3 was observed providing care in the Observation Unit. RN 3 stated she had to get Patient 206's medication from the pharmacy as it was not in the unit. During an interview with the Observation Unit Manager, on February 26, 2015, at 10:10 a.m., the Manager stated they did not have a pyxis refrigerator in the unit, so they had to obtain medications from the pharmacy. In addition, the Manager stated as the patient's were transient (short stay or transfers), daily medications were not sent to the unit. The Manager stated the patient's nurse would call the pharmacy about an hour before the patient's medication was due, to receive the medication. During an observation of the OBS unit on February 26, 2015, between 9:30 and 10:15 a.m., there were 15 patients in the unit with each privacy curtain closed around the respective bed. A [AGE] year old female, admitted the previous day for complaints of chest pain, was heard yelling through the curtain, it's hot in here. Staff opened the curtains, and exposed the patient to the other patients, staff, and visitors in the unit. The facility policy titled, Plan for the Provision of Patient Care - Scope of Service, was reviewed on February 26, 2015. The policy indicated the following: A. The observation unit was used to care for patients requiring further management, specifically to determine the need for inpatient admission, who met criteria for medical, surgical, and telemetry level of care up to a 24 hour stay; B. The observation unit was for patients where diagnosis, treatment, stabilization, and discharge could reasonably be expected within 24 hours; C. Acceptable diagnoses for the Observation unit included diagnoses such as non-specific chest pain (chest pain without an identified cause), anemia, non-titrated IV medications (not needing to increase and decrease rates to manage symptoms), cardiac arrhythmias (abnormal heart rhythms), elective angiograms, interventional radiology procedures, and same day surgery; D. Acceptable diagnoses for the Cardiovascular unit (CVU) included acute myocardial infarction (heart attack) (the diagnosis Patient 204 had), cardiac dysrhythmias (abnormal heart rhythms), and stroke (the type of diagnoses Patients 109 and 111 had). Staffing in the unit was one nurse for every three patients, and the nursing staff provided continuous cardiac monitoring; and, E. The Progressive Care unit (PCU) was for patients who were stable with the potential for becoming unstable. Acceptable diagnoses for the PCU included stable myocardial infarction and acute coronary syndrome (the diagnosis Patient 110 had). Staffing in the unit was one nurse for every three patients, and the nursing staff provided continuous cardiac monitoring. During an interview with the [NAME] President (VP) of Quality on February 25, 2015, at 2:30 p.m., the VP stated Patients 109, 110, 111, and 204 should have been admitted to the inpatient areas, but there were no rooms available for them. During an interview with the VP of Quality on February 26, 2015, at 1:55 p.m., the VP stated there was no data being collected or analyzed to determine the appropriateness of the diagnoses, length of stay, or care needs of the patients being admitted to the observation unit. 2. Review of the clinical record for Patient 501 on February 26, 2015, with the clinical pharmacy manager (CPM) and Director of Pharmacy (DPH), revealed that he was admitted to the hospital on January 31, 2015, for complaints of worsening shortness of breath. Patient 501 was diagnosed with stage four lung cancer in December 2014, and had a history of tobacco use and chronic obstructive pulmonary disease (COPD). The following narcotic (opioid) pain medications were prescribed for pain relief during his hospital stay: 1. January 31, 2015, Morphine Sulfate 4mg (milligrams) intravenously (IV) every six hours as needed for severe pain; 2. January 31, 2015, Norco 5/325 mg; two tablets by mouth every four hours as needed for moderate pain; 3. February 3, 2015, Morphine Sulfate 15 mg tablet by mouth every 12 hours; and, 4. February 4, 2015, Fentanyl patch 25 mcg (micrograms)/hour; apply one patch every 72 hours. Review of the medication administration record (MAR) with the CPM showed the above opioid medications were administered on the following dates and times: Norco 5 mg was given on February 2, 2015, at 2:54 p.m., and February 3, 2015, at 11:35 a.m.; Morphine sulfate 4mg intravenous (IV) was given on February 3, 2015, 7:28 p.m., and on February 4, 2015, at 12:03 p.m., and at 12:45 p.m. hours; Morphine sulfate 15mg tablet was given on February 3, 2015 at 9:45 a.m., and on February 4, 2015 at 8:58 a.m. Further review of his medication administration record (MAR) also revealed fentanyl 25 mcg/hour transdermal patch (topical narcotic pain relief patch) was later administered on February 4, 2015, at 3:49 p.m., by his nurse. According to the hospital medication reconciliation record dated January 31, 2015, there was no documented evidence that Patient 501 was on any form of opioid pain medication prior to hospital admission. Based on the duration and the amount of opioid exposure prior to administration of the fentanyl patch, Patient 501 was improperly prescribed and subsequently administered a fentanyl patch according to the Food and Drug Adminisration (FDA) boxed warning. The boxed warning for transdermal Duragesic (topical narcotic type pain relief medication; also called fentanyl patches), which the FDA required to be included with all containers of the drug, read, Duragesic (brand name for transdermal fentanyl) is ONLY for use in patients who are already tolerant to opioid (narcotic type pain relief medications) therapy of comparable potency. Use in non-opioid tolerant patients may lead to fatal respiratory depression. Also included in the warning was, Duragesic should ONLY be used in patients who already are receiving opioid therapy who have demonstrated opioid tolerance, and who require a total daily dose at least equivalent to Duragesic 25 mcg/hour. Patients who are considered opioid-tolerant are those who have been taking, for a week or longer, at least 60 mg of morphine (an opioid) daily, or at least 30 mg of oral oxycodone (an opioid) daily, or at least 8 mg of oral hydromorphone (an opioid) daily or an equianalgesic dose of another opioid. During an interview with the CPM and the DPH on February 26, 2015, at 11:43 a.m., they both acknowledged that Patient 501 had not been on the opioid pain medications long enough to be considered opioid tolerant according to the FDA's boxed warning definition. They also confirmed there was currently no hospital guideline or procedure for prescribing or reviewing a fentanyl patch order to ensure that the patient was opioid tolerant prior to receiving any fentanyl patch.

Violation Name: PATIENT SAFETY(A-0286)

• Inspection Date: 2015-02-26 (Event ID: OTPT11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** 22764 Based on interview and record review, the facility failed to ensure: 1. Actions were taken to prevent further medication errors after an investigation into a medication error resulting in cardiac arrest was carried out, and necessary preventative actions were identified; and, 2. An adverse event related to failure to medicate a patient as ordered, and a subsequent fall resulting in a fatal head injury, was appropriately investigated and analyzed, and preventative actions were planned and implemented. These failed practices resulted in the potential for further medication errors that could lead to patient harm or death. Findings: The Performance Improvement and Patient Safety Plan, with an approval date of [DATE], was reviewed on February 24, 2015. The plan indicated the following: a. Goals included reducing medical/health system errors by identifying and managing risks to patient safety; b. Objectives included facilitating an environment that encouraged recognition and acknowledgement of risks to patient safety and medical errors, and initiating action to reduce those risks; c. Information from data analysis would be used to implement change that would improve the quality of care and patient safety; and, d. After necessary actions were determined and implemented, they would be monitored and evaluated to assure effective change. 1. During the investigation of an entity reported incident on [DATE], the following was revealed: Patient 100 was admitted to the facility on [DATE], with diagnoses that included diabetes, hypertension (HTN), hyperlipidemia (high levels of fat in the blood - such as cholesterol), left bundle branch block (LBBB - cardiac rhythm abnormality), and worsening of previously diagnosed congestive heart failure (CHF). According to the record, Patient 100 was taken to the cardiac cath lab on [DATE], for a right and left heart catheterization (using catheters and contrast to measure pressures in the heart, view the coronary arteries and assess for blockages, and determine the pumping effectiveness of the ventricle). The cath lab progress notes indicated the following: a. Patient 100 was placed on the cath lab table at 8:41 a.m.; b. The procedure was started at 8:54 a.m., and completed at 9:17 a.m. During the procedure, a blockage was seen in the middle portion of the left anterior descending (LAD) coronary artery, and the cardiologist decided to perform a fractional flow reserve (FFR - an elective procedure, not an emergency) test to determine how significant the blockage was; c. At 9:17 a.m., the patient's blood pressure (BP) was normal at ,d+[DATE] (normal ,d+[DATE]), with a normal heart rate of 64 (normal ,d+[DATE]); d. At 9:18 a.m., an angiomax bolus was administered intravenous (IV) (to prevent blood clots from forming during the procedure), and the catheter for the procedure was inserted; e. At 9:21 a.m., a continuous infusion of angiomax was started; f. At 9:22 a.m., the patient's BP was ,d+[DATE] (normal), and his heart rate was 61 (normal). The guidewire for the procedure was inserted; e. At 9:27 a.m., adenosine (a medication that causes a fast acting/short lasting vasodilation [arteries open bigger and wider] and slowing of the heart to determine how big the vessel is and how adequate the flow is distal to [past] the blockage) was started IV at a fast rate (646 ml [milliliters] per hour); f. At 9:27 a.m. (the same time), the nurse realized that an error had occurred, and adrenaline (epinephrine - a medication that causes a sudden onset of vasoconstriction [arteries become smaller] and increase in heart rate and blood pressure) was started instead of adenosine, at the same rate, and given for a duration of 15 seconds for a total of 0.99 mg of epinephrine IV; g. At 9:27 a.m. (seconds later), the patient's blood pressure (BP) increased to ,d+[DATE]; h. At 9:28 a.m., Patient 100 was complaining of difficulty breathing, and a code blue was called; i. At 9:29 a.m., the code team arrived and cardiopulmonary resuscitation (CPR) was started. According to the record, the patient's heart rate increased to 175, but CPR was continued due to inability to obtain a BP until 9:35 a.m. (for six minutes). Patient 100 was intubated (a tube was inserted into his mouth, past his vocal chords, and into his trachea to assist in giving him artificial breathing). One hour later he was stabilized and transferred to the intensive care unit (ICU). The Code Blue Report, dictated [DATE], at 12:08 p.m., indicated a blockage was seen in the middle portion of the left anterior descending (LAD) coronary artery, and the cardiologist decided to perform a fractional flow reserve (FFR) test to determine how significant the blockage was. According to the report, instead of receiving adenosine (as ordered and planned) (a medication that causes a fast acting/short lasting vasodilation [arteries open bigger and wider] and slowing of the heart to determine how big the vessel is and how adequate the flow is distal to [past] the blockage), the patient received received adrenaline (epinephrine - a medication that causes a sudden onset of vasoconstriction [arteries become smaller] and increase in heart rate and blood pressure [BP]). The patient complained of severe chest pain, his BP increased to approximately 300 systolic (top number - normal 120), then he started having shortness of breath and was coughing up copious (extremely large) amounts of blood. A code blue was called, and cardiopulmonary resuscitation (CPR) was started and continued for approximately five minutes until a pulse was felt. The patient was intubated (a tube was inserted into his mouth, past his vocal chords, and into his trachea to assist in giving him artificial breathing), stabilized, and transferred to the intensive care unit (ICU). The facility reference titled, ADENOSINE PREPARATIONS, was reviewed on February 26, 2015. The reference indicated intravenous (IV) adenosine for use in the cath lab FFR procedure was to be mixed as follows: A. Remove 40 cc (milliliters) of normal saline from a 100 cc bag; B. Add one vial (90 mg/30 cc [milligrams/milliliters]) of adenosine; C. Result is (1 mg/cc) 90 mg adenosine in 90 cc normal saline; D. Dosage to be infused is 140 mcg/kg/min (micrograms per kilogram per minute); and, E. Drip rate to be used is 8.4 X pt weight (kg) (times the patient's weight in kilograms). During an interview with the Cath Lab Director (CLD) on [DATE], at 10:20 a.m., and on February 26, 2015, at 12:40 p.m., the director stated Patient 100 had a heart cath done in mid December. The director stated a blockage was identified, and the cardiologist wanted to perform an FFR to determine the severity of the blockage and the possible need for intervention to open the vessel. The director stated the physician ordered Cath Lab Registered Nurse (CLRN) 1 to proceed with preparation of angiomax and adenosine infusions. The director stated CLRN 1 removed angiomax from the pyxis station (automated dispensing cabinet), and handed it to her colleague (CLRN 2) to prepare. The director stated CLRN 1 then removed adenosine from the pyxis station, prepared an infusion, then handed it to CLRN 2 to prime the tubing and set the infusion rate on the pump. The infusion was readied and started by CLRN 2. According to the director, after the adenosine infusion was started, CLRN 1 went to scan the medication and label the bag, and realized she had mixed an adrenaline infusion instead of an adenosine infusion. CLRN 1 notified the physician, the infusion was stopped, and the patient began to decompensate, requiring intubation, CPR, and a transfer to ICU. The director stated the facility investigation revealed CLRN 1 removed adrenoline from the pyxis instead of adenosine, assumed it was the correct medication, and did not check the vial. The director stated CLRN 1 did not scan the medication until after she mixed the infusion, and did not label the bag until after the infusion was started. In order for the incorrect medication to be infused, the following failures occurred: a. CLRN 1 removed the wrong medication from the pyxis station, not verifying the medication when she removed it; b. CLRN 1 failed to scan the medication vial when she removed it; c. CLRN 1 mixed the infusion, using the wrong medication vial; d. CLRN 1 failed to label the medication infusion bag until after it was started; e. CLRN 1 handed an unlabeled medication bag to CLRN 2 for the infusion to be started; and, f. CLRN 2 accepted an unlabeled IV medication bag and started an infusion. The facility investigation was reviewed on [DATE] and again on February 26, 2015, with the [NAME] President (VP) of Quality. The investigation identified actions that needed to be taken to prevent reoccurrence of the error as follows: a. Registered Nurses (RNs) to follow medication administration policy; b. Review/research for competencies for RNs mixing/preparing medications; c. Review procedure for medication administration (including handing off medications to other nurses); and, d. Consider having pharmacy mix/prepare all intravenous (IV) infusions. During an interview, the VP stated the nurses would continue to mix/prepare IV infusions in the specialty areas, and they had a reference to use if they had questions. The VP stated she did not know whether competency verification had been done for the nurses who mixed/prepared IV infusions (a requirement according to the medication administration policy, and a necessary action item according to the facility investigation). She stated the cath lab director would know. During an interview with CLRN 3 on February 24, 2015, the RN stated the nurses in the cath lab currently prepared/mixed four different medications for infusion; angiomax, adenosine, neosynephrine (for blood pressure support), and levophed (for blood pressure support). The facility policy titled, Medication Administration, was reviewed on Janaury 7 and February 26, 2015. The policy indicated all staff administering medications at the facility would have their competence validated prior to administering medications and periodically thereafter. A review of cath lab education records indicated in [DATE] (three years earlier) 10 of 19 nurses from the cath lab demonstrated competency in mixing IV infusions. The list did not include CLRN 1. There was no evidence the facility ever verified CLRN 1 was competent to mix IV infusions. There was no evidence CLRN 2 had demonstrated competence in mixing IV infusions for the past three years. During an interview with the CLD on February 26, 2015, at 12:40 p.m., the director stated the department had not done competency verification for nurses preparing IV infusions since he started working there (for two years). 2. During the investigation of an adverse event on [DATE], the record for Patient 112 was reviewed with the Director of Quality (DQ), and the Emergency Department (ED) Manager. Patient 112, a [AGE] year old male, was admitted to the facility on [DATE], at 11:33 p.m., with diagnoses that included hypertensive urgency (abnormally high blood pressure that must be lowered). The History and Physical dated [DATE], indicated Assessment and plan: The patient presented to outside hospital with a systolic blood pressure 245 over a diastolic of 100. He had accompanying shortness of breath .on exam he does have bibasilar lung sounds (abnormal) and his blood pressure is markedly elevated .the patient will benefit most from a nephrology (kidney) consult for dialysis as well as titration (to continuously measure) of blood pressure medications . (Normal blood pressure range is less than 120 mm systolic, and less than 80 mm diastolic. Reference from American Heart Association). The nurse's notes indicated on [DATE], at 7:28 a.m., RN 1 notified the physician that Patient 112's blood pressure was ,d+[DATE], and received an order to give Patient 112 the medication Hydralazine (a medication used to lower/control elevated blood pressure). The nurse's note entry for 7:34 a.m., indicated Pt (patient) report given to .RN 5. Pt care transferred .RN 5 aware of new order for Hydralazine IVP (intravenous push - given into a vein). The admission assessment dated [DATE], at 7:30 a.m., indicated .awaiting Hydralizine for elevated B/P (blood pressure). The nurse's notes (late) entry dated [DATE], at 4:40 p.m., indicated 09:58 a.m Found Patient 112 lying on floor with obvious bleeding .SBP ,d+[DATE] . The medication administration record indicated Patient 112 received the medication to lower his elevated blood pressure at 10:36 a.m., three hours and eight minutes after the RN received the order, and 28 minutes after Patient 112 was found on the floor with a head injury. Patient 112 was admitted with diagnoses to include elevated blood pressure. There was a physician's order to give medication to lower Patient 112's blood pressure.The RN did not administer the medication ordered to control Patient 112's blood pressure in a timely manner. Patient 112 was found on the ED bathroom floor with a blood pressure of ,d+[DATE]. The Coroner's investigation report indicated Patient 112 died on [DATE], from a brain hemorrhage which resulted from blunt force head trauma following the fall in the ED on [DATE]. During an interview with the Director of Risk Management (DRM), on [DATE], at 12:45 p.m., the DRM stated the facility had completed an investigation of the incident and determined Patient 112 was stable prior to his fall and able to ambulate to the bathroom without assistance. The DRM stated the facility determined Patient 112's fall was an unavoidable accident. The DRM stated she was unaware of Patient 112's elevated blood pressure, the delay in physician call back , and the delay in the treatment for an elevated blood pressure. She stated these issues did not come during the investigation. The DRM stated the incident involving Patient 112 would be reviewed again with Department heads.

Violation Name: NURSING SERVICES(A-0385)

• Inspection Date: 2015-02-26 (Event ID: OTPT11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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25937 Based on interview and record review, the facility failed to ensure it provided an organized nursing service to all patients by failing to ensure: 1. An initial skin assessment and interventions were implemented for one sampled patient (Patient 406) according to the facility policy. (A396); 2. Implementation and documentation for tracheostomy care was performed per facility policy for one sampled patient (Patient 408). (A396); 3. Registered Nurses (RNs) in the cardiac cath lab demonstrated competency in mixing critical intravenous (IV) medications for infusion during cardiac procedures prior to assigning them the task, resulting in a significant medication error and cardiac arrest of one patient (Patient 100) (A397); 4. Labor and Delivery (L&D) registered nurses (RNs) were qualified to perform a Medical Screening Exam (MSE), as per policy. The RNs did not have their competency to perform an MSE validated by an Obstetrician on staff, and MSE was not part of the L&D RN's annual competencies, resulting in RNs performing MSEs (a standardized procedure) without validated competencies (A397); 5. Intravenous (IV) medications were prepared and administered correctly and by competent individuals when the wrong IV medication was prepared and infused to one patient (Patient 100), resulting in cardiac arrest requiring resuscitation (A405); 6. One patient (Patient 112) received medication to lower his blood pressure in a timely manner. This failed practice may have resulted in the death of Patient 112. (A405); and 7. Medications were prepared in the pharmacy and sent to the observation unit to be administered to patients prior to the time they were due to be given, resulting in medications being administered late. (A405). The cumulative effects of these systemic problems resulted in failure of the nursing department to ensure care was being provided in a safe and effective manner.

Violation Name: NURSING CARE PLAN(A-0396)

• Inspection Date: 2015-02-26 (Event ID: OTPT11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** 31688 Based on interview and record review the facility failed to: 1. Ensure an initial skin assessment and interventions were implemented for one sampled patient, (Patient 406) per facility policy; and 2. Ensure implementation and documentation for tracheostomy care was performed per facility policy for one sampled patient, (Patient 408). These failed interventions had the potential to delay the necessary care and treatment of Patients 406 and 408's skin conditions which had the potential to decrease wound healing and prolong hospital stay. Findings: 1. According to the National Pressure Ulcer Advisory Panel, an unstageable pressure ulcer is a full thickness skin or tissue loss - depth unknown. (Full thickness tissue loss in which actual depth of the ulcer is completely obscured by slough (yellow, tan, gray, green or brown) and/or eschar (tan, brown or black) in the wound bed). Until enough slough and/or eschar are removed to expose the base of the wound, the true depth cannot be determined. Record review was conducted for Patient 406's on February 26, 2015. The record indicated Patient 406 was admitted to the facility with an unstageable coccyx (low back) pressure wound on February 19, 2015. The admission assessment Braden score (risk for skin breakdown) for Patient 406 was 19 (high risk). The facility's first measurement of the coccyx wound was on February 22, 2015, three days after Patient 406's admission. The unstageable coccyx wound measured 2 centimeters (cm) long by 2 cm wide, with no depth. An interview was conducted with the Surgical Intensive Care Unit Manager (SICM) on February 26, 2015, at 11:45 a.m. The SICM stated, The admitting nurse who documented the unstageable skin issue on February 19, 2015, should have documented the measurements. Record review was conducted with the SICM present. The SICM stated The nurses should have followed up and requested a physician order for a Wound Consult. As of February 26, 2015, a wound consult was not ordered for Patient 406, seven days after admission with an unstageable pressure ulcer and a Braden score of 19 (which indicated high risk for further skin breakdown). Record review of the facility policy titled, Photography of Skin Conditions, revised October 2014, indicated, .A full wound assessment should minimally include: wound type, stage, (if pressure ulcer related) measurements, drainage type and amount, odor, wound base tissue, types and percentages, periwound surrounding skin, .any other findings as well as how the affected area was cleaned, prepped, and type of dressing applied. The policy further indicated,Consults can be requested for the at risk patient when there is an identified need .wound debridement or wound care specialist consultation with difficult to manage wounds or high risk for skin breakdown. 2. Patient 408 was admitted to the facility on [DATE], with the diagnosis of multiple facial lacerations post motor vehicle accident which required placement of a tracheostomy (temporary or permanent airway surgically placed in the lower neck). Patient 408's tracheostomy was placed on February 23, 2015. Record review was conducted for Patient 408 on February 26, 2015. The record indicated Patient 408 had two documented entries for a twenty four hour period regarding post operative care (dressing change and assessment) of her tracheostomy; one entry documented at 4 a.m. and one entry documented at 8 p.m., both on February 24, 2015. An interview was conducted with the Surgical Intensive Care Unit Manager (SICM) on February 26, 2015 at 11:50 a.m. The SICM stated, The facility policy post tracheostomy was for nursing to assess, administer (skin care), and document the skin status of a new tracheostomy every four hours post placement (for twenty four hours). Documentation on Patient 408's record indicated the nurses did not document their assessment and interventions per facility policy every four hours post tracheostomy placement. A record review of the facility policy titled, Tracheostomy Care, revised September 2012, indicated, .Patients with less than twenty four hours (24) post-op tracheostomy will receive trach care every four hours.

Violation Name: PATIENT CARE ASSIGNMENTS(A-0397)

• Inspection Date: 2015-02-26 (Event ID: OTPT11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** 22764 Based on interview and record review, the facility failed to ensure: 1. Registered Nurses (RNs) in the cardiac cath lab demonstrated competency in mixing critical intravenous (IV) medications for infusion during cardiac procedures prior to assigning them the task, resulting in a significant medication error and cardiac arrest of one patient (Patient 100); and, 2. Labor and Delivery (L&D) registered nurses (RNs) were qualified to perform a Medical Screening Exam (MSE), as per policy. The RNs did not have their competency to perform an MSE validated by an Obstetrician on staff, and MSE was not part of the L&D RN's annual competencies, resulting in RNs performing MSEs (a standardized procedure) without validated competencies. Findings: 1. During the investigation of an entity reported incident on [DATE], the following was revealed: Patient 100 was admitted to the facility on [DATE], with diagnoses that included diabetes, hypertension (HTN), hyperlipidemia (high levels of fat in the blood - such as cholesterol), left bundle branch block (LBBB - cardiac rhythm abnormality), and worsening of previously diagnosed congestive heart failure (CHF). Patient 100 was taken to the cardiac cath lab on [DATE], for a right and left heart catheterization (using catheters and contrast to measure pressures in the heart, view the coronary arteries and assess for blockages, and determine the pumping effectiveness of the ventricle). A Code Blue Report, dictated [DATE], at 12:08 p.m., indicated a blockage was seen in the middle portion of the left anterior descending (LAD) coronary artery, and the cardiologist decided to perform a fractional flow reserve (FFR - an elective procedure, not an emergency) test to determine how significant the blockage was. According to the report, instead of receiving adenosine (a medication that causes a fast acting/short lasting vasodilation [arteries open bigger and wider] and slowing of the heart to determine how big the vessel is and how adequate the flow is past the blockage) as ordered, the patient received adrenaline (epinephrine - a medication that causes a sudden onset of vasoconstriction [arteries become smaller] and increase in heart rate and blood pressure [BP]). The facility reference titled, ADENOSINE PREPARATIONS, was reviewed on February 26, 2015. The reference indicated intravenous (IV) adenosine for use in the cath lab FFR procedure was to be mixed as follows: A. Remove 40 cc (milliliters) of normal saline from a 100 cc bag; B. Add one vial (90 mg/30 cc [milligrams/milliliters]) of adenosine; C. Result is (1 mg/cc) 90 mg adenosine in 90 cc normal saline; D. Dosage to be infused is 140 mcg/kg/min (micrograms per kilogram per minute); and, E. Drip rate to be used is 8.4 X pt weight (kg) (times the patient's weight in kilograms). According to the code blue record, the patient complained of severe chest pain, his BP increased to approximately 300 systolic (top number - normal 120), then he started having shortness of breath and was coughing up copious (extremely large) amounts of blood. A code blue was called, and cardiopulmonary resuscitation (CPR) was started and continued for approximately five minutes until a pulse was felt. The patient was intubated (a tube was inserted into his mouth, past his vocal chords, and into his trachea to assist in giving him artificial breathing), stabilized, and transferred to the intensive care unit (ICU). During an interview with the Cath Lab Director (CLD) on [DATE], at 10:20 a.m., and on February 26, 2015, at 12:40 p.m., the director stated Patient 100 had a heart cath done in mid December. The director stated a blockage was identified, and the cardiologist wanted to perform an FFR to determine the severity of the blockage and the possible need for intervention to open the vessel. The director stated the physician ordered Cath Lab Registered Nurse (CLRN) 1 to proceed with preparation of angiomax (to prevent blood from clotting) and adenosine infusions. The director stated CLRN 1 removed angiomax from the pyxis station (automated dispensing cabinet), and handed it to her colleague (CLRN 2) to prepare. The director stated CLRN 1 then removed adenosine from the pyxis station, prepared an infusion, then handed it to CLRN 2 to prime the tubing and set the infusion rate on the pump. The infusion was readied and started by CLRN 2. According to the director, after the adenosine infusion was started, CLRN 1 went to scan the medication and label the bag, and realized she had mixed an adrenaline infusion instead of an adenosine infusion. CLRN 1 notified the physician, the infusion was stopped, and the patient began to decompensate, requiring intubation, CPR, and a transfer to ICU. The director stated the facility investigation revealed CLRN 1 removed adrenoline from the pyxis instead of adenosine, assumed it was the correct medication, and did not check the vial. The director stated CLRN 1 did not scan the medication until after she mixed the infusion, and did not label the bag until after the infusion was started. In order for the incorrect medication to be infused, the following failures occurred: a. CLRN 1 removed the wrong medication from the pyxis station, not verifying the medication when she removed it; b. CLRN 1 failed to scan the medication vial when she removed it; c. CLRN 1 mixed the infusion, using the wrong medication vial; d. CLRN 1 failed to label the medication infusion bag until after it was started; e. CLRN 1 handed an unlabeled medication bag to CLRN 2 for the infusion to be started; and, f. CLRN 2 accepted an unlabeled IV medication bag and started an infusion. During an interview with CLRN 3 on February 24, 2015, the RN stated the nurses in the cath lab currently prepared/mixed four different medications for infusion; angiomax, adenosine, neosynephrine (for blood pressure support), and levophed (for blood pressure support). The facility policy titled, Medication Administration, was reviewed on [DATE] and February 26, 2015. The policy indicated all staff administering medications at the facility would have their competence validated prior to administering medications and periodically thereafter. A review of cath lab education records indicated in [DATE] (three years earlier) 10 of 19 nurses from the cath lab demonstrated competency in mixing/preparing IV infusions. The list did not include CLRN 1. There was no evidence the facility ever verified CLRN 1 was competent to mix/prepare IV infusions. There was no evidence CLRN 2 (or any other cath lab nurses) had demonstrated competence in mixing/preparing IV infusions for the past three years. The employee file for CLRN 1 was reviewed on February 26, 2015. The file indicated on [DATE], CLRN 1 received a final written warning after she administered an incorrect medication to a patient. The recommended action for CLRN 1 was to administer correct patient medications as ordered by the physician. There was no evidence of action taken to determine the cause of the [DATE] error, determine the need for education or training, or monitor the nurse for competence in medication administration. During an interview with the CLD on February 26, 2015, at 12:40 p.m., the director stated the department had not done competency verification for nurses preparing IV infusions since he started working there (for two years). The director stated CLRN 1 had been disciplined in July for a medication error, and there was no remediation or monitoring done after the discipline was completed. 25937 2. On February 25, 2015, at 10 a.m., Registered Nurse 10 was interviewed. RN 10 stated she worked in L&D, and was able to perform MSEs. RN 10 stated she was checked off and was competent to perform an MSE. RN 10 stated an RN has to have worked in the department awhile before being allowed to perform an MSE. On February 26, 2015, at 1:30 p.m., the Obstetric Medical Screening Competency Report, was reviewed with the Labor and Delivery Manager (LDM). RN 10's name did not appear on the report. The LDM stated the report was old, and she did not have a current report to list all nurses that were checked off. The LDM further stated all nurses currently working in L&D were considered competent to perform MSEs. On February 26, 2015, the employee file for RN 11 was reviewed. There was no documented evidence of an initial competency to perform an MSE. In addition, MSEs were not part of the annual competencies for 2014. On February 26, 2015, at 1:30 p.m., the Labor and Delivery Manager (LDM) was interviewed. The LDM stated RN 11's name appeared on the Obstetric Medical Screening Competency Report, dated [DATE], but was unable to find the documented evidence of the initial competency being validated by an obstetrician (OB). The LDM stated all the RNs were checked off by another RN (not by an OB doctor), and required to take an exam, to verify competency to perform an MSE. The LDM further stated, the standardized procedure for an MSE was not part of annual competencies for L&D RNs. The policy and procedure titled, Standardized Procedure --SP-18 Medical Screening Exam (MSE) Process, dated [DATE], was reviewed. The policy indicated, Qualified to perform . A Qualified Registered Nurse who has been competency validated for the Labor and Delivery Medical Screening Exam. The policy defined competency validated as: i. Qualifications for Registered Nurses: Completes competency for Medical Screening Exam, validated by medical staff with privileges in Obstetrics . ii. Evaluations: Initial evaluation at completion of orientation and then annually from date of hire . Annual employee evaluation will include core competencies. iii. Written Record: A list of person authorized to perform the standardized function will be kept on file with Nursing Administration and in the Labor and Delivery Department and will be updated concurrently .

Violation Name: ADMINISTRATION OF DRUGS(A-0405)

• Inspection Date: 2015-02-26 (Event ID: OTPT11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** 22764 Based on interview and record review, the facility failed to ensure: 1. Intravenous (IV) medications were prepared and administered correctly and by competent individuals when the wrong IV medication was prepared and infused to one patient (Patient 100), resulting in cardiac arrest requiring resuscitation; 2. One patient (Patient 112) received medication to lower his blood pressure in a timely manner. This failed practice may have resulted in the death of Patient 112; and, 3. Medications were prepared in the pharmacy and sent to the observation unit to be administered to patients prior to the time they were due to be given, resulting in medications being administered late. Findings: 1. During the investigation of an entity reported incident on [DATE], the following was revealed: Patient 100 was admitted to the facility on [DATE], with diagnoses that included diabetes, hypertension (HTN), hyperlipidemia (high levels of fat in the blood - such as cholesterol), left bundle branch block (LBBB - cardiac rhythm abnormality), and worsening of previously diagnosed congestive heart failure (CHF). According to the record, Patient 100 was taken to the cardiac cath lab on [DATE], for a right and left heart catheterization (using catheters and contrast to measure pressures in the heart, view the coronary arteries and assess for blockages, and determine the pumping effectiveness of the ventricle). The cath lab progress notes indicated the following: a. Patient 100 was placed on the cath lab table at 8:41 a.m.; b. The procedure was started at 8:54 a.m., and completed at 9:17 a.m. During the procedure, a blockage was seen in the middle portion of the left anterior descending (LAD) coronary artery, and the cardiologist decided to perform a fractional flow reserve (FFR - an elective procedure, not an emergency) test to determine how significant the blockage was; c. At 9:17 a.m., the patient's blood pressure (BP) was normal at ,d+[DATE] (normal ,d+[DATE]), with a normal heart rate of 64 (normal ,d+[DATE]); d. At 9:18 a.m., an angiomax bolus was administered intravenous (IV) (to prevent blood clots from forming during the procedure), and the catheter for the procedure was inserted; e. At 9:21 a.m., a continuous infusion of angiomax was started; f. At 9:22 a.m., the patient's BP was ,d+[DATE] (normal), and his heart rate was 61 (normal). The guidewire for the procedure was inserted; e. At 9:27 a.m., adenosine (a medication that causes a fast acting/short lasting vasodilation [arteries open bigger and wider] and slowing of the heart to determine how big the vessel is and how adequate the flow is distal to [past] the blockage) was started IV at a fast rate (646 ml [milliliters] per hour); f. At 9:27 a.m. (the same time), the nurse realized that an error had occurred, and adrenaline (epinephrine - a medication that causes a sudden onset of vasoconstriction [arteries become smaller] and increase in heart rate and blood pressure) was started instead of adenosine, at the same rate, and given for a duration of 15 seconds for a total of 0.99 mg of epinephrine IV; g. At 9:27 a.m. (seconds later), the patient's blood pressure (BP) increased to ,d+[DATE]; h. At 9:28 a.m., Patient 100 was complaining of difficulty breathing, and a code blue was called; i. At 9:29 a.m., the code team arrived and cardiopulmonary resuscitation (CPR) was started. According to the record, the patient's heart rate increased to 175, but CPR was continued due to inability to obtain a BP until 9:35 a.m. (for six minutes). Patient 100 was intubated (a tube was inserted into his mouth, past his vocal chords, and into his trachea to assist in giving him artificial breathing). One hour later he was stabilized and transferred to the intensive care unit (ICU). The Code Blue Report, dictated [DATE], at 12:08 p.m., indicated a blockage was seen in the middle portion of the left anterior descending (LAD) coronary artery, and the cardiologist decided to perform a fractional flow reserve (FFR) test to determine how significant the blockage was. According to the report, instead of receiving adenosine (as ordered and planned) (a medication that causes a fast acting/short lasting vasodilation [arteries open bigger and wider] and slowing of the heart to determine how big the vessel is and how adequate the flow is distal to [past] the blockage), the patient received received adrenaline (epinephrine - a medication that causes a sudden onset of vasoconstriction [arteries become smaller] and increase in heart rate and blood pressure [BP]). The patient complained of severe chest pain, his BP increased to approximately 300 systolic (top number - normal 120), then he started having shortness of breath and was coughing up copious (extremely large) amounts of blood. A code blue was called, and cardiopulmonary resuscitation (CPR) was started and continued for approximately five minutes until a pulse was felt. The patient was intubated (a tube was inserted into his mouth, past his vocal chords, and into his trachea to assist in giving him artificial breathing), stabilized, and transferred to the intensive care unit (ICU). The facility reference titled, ADENOSINE PREPARATIONS, was reviewed on February 26, 2015. The reference indicated intravenous (IV) adenosine for use in the cath lab FFR procedure was to be mixed as follows: A. Remove 40 cc (milliliters) of normal saline from a 100 cc bag; B. Add one vial (90 mg/30 cc [milligrams/milliliters]) of adenosine; C. Result is (1 mg/cc) 90 mg adenosine in 90 cc normal saline; D. Dosage to be infused is 140 mcg/kg/min (micrograms per kilogram per minute); and, E. Drip rate to be used is 8.4 X pt weight (kg) (times the patient's weight in kilograms). During an interview with the Cath Lab Director (CLD) on [DATE], at 10:20 a.m., and on February 26, 2015, at 12:40 p.m., the director stated Patient 100 had a heart cath done in mid December. The director stated a blockage was identified, and the cardiologist wanted to perform an FFR to determine the severity of the blockage and the possible need for intervention to open the vessel. The director stated the physician ordered Cath Lab Registered Nurse (CLRN) 1 to proceed with preparation of angiomax and adenosine infusions. The director stated CLRN 1 removed angiomax from the pyxis station (automated dispensing cabinet), and handed it to her colleague (CLRN 2) to prepare. The director stated CLRN 1 then removed adenosine from the pyxis station, prepared an infusion, then handed it to CLRN 2 to prime the tubing and set the infusion rate on the pump. The infusion was readied and started by CLRN 2. According to the director, after the adenosine infusion was started, CLRN 1 went to scan the medication and label the bag, and realized she had mixed an adrenaline infusion instead of an adenosine infusion. CLRN 1 notified the physician, the infusion was stopped, and the patient began to decompensate, requiring intubation, CPR, and a transfer to ICU. The director stated the facility investigation revealed CLRN 1 removed adrenoline from the pyxis instead of adenosine, assumed it was the correct medication, and did not check the vial. The director stated CLRN 1 did not scan the medication until after she mixed the infusion, and did not label the bag until after the infusion was started. In order for the incorrect medication to be infused, the following failures occurred: a. CLRN 1 removed the wrong medication from the pyxis station, not verifying the medication when she removed it; b. CLRN 1 failed to scan the medication vial when she removed it; c. CLRN 1 mixed the infusion, using the wrong medication vial; d. CLRN 1 failed to label the medication infusion bag until after it was started; e. CLRN 1 handed an unlabeled medication bag to CLRN 2 for the infusion to be started; and, f. CLRN 2 accepted an unlabeled IV medication bag and started an infusion. During an interview with CLRN 3 on February 24, 2015, the RN stated the nurses in the cath lab currently prepared/mixed four different medications for infusion; angiomax, adenosine, neosynephrine (for blood pressure support), and levophed (for blood pressure support). The facility policy titled, Medication Administration, was reviewed on Janaury 7 and February 26, 2015. The policy indicated all staff administering medications at the facility would have their competence validated prior to administering medications and periodically thereafter. A review of cath lab education records indicated in [DATE] (three years earlier) 10 of 19 nurses from the cath lab demonstrated competency in mixing IV infusions. The list did not include CLRN 1. There was no evidence the facility ever verified CLRN 1 was competent to mix IV infusions. There was no evidence CLRN 2 had demonstrated competence in mixing IV infusions for the past three years. The employee file for CLRN 1 was reviewed on February 26, 2015. The file indicated on [DATE], CLRN 1 received a final written warning after she administered an incorrect medication to a patient. The recommended action for CLRN 1 was to administer correct patient medications as ordered by the physician. There was no evidence of action taken to determine the cause of the [DATE] error, determine the need for education or training, or monitor the nurse for competence in medication administration. During an interview with the CLD on February 26, 2015, at 12:40 p.m., the director stated the department had not done competency verification for nurses preparing IV infusions since he started working there (for two years). The director stated CLRN 1 had been disciplined in July for a medication error, and there was no remediation or monitoring done after the discipline was completed. 29542 2. The record for Patient 112 was reviewed. Patient 112 was transferred from another facility to the Emergency Department (ED), on [DATE], at 11:33 pm., with the chief complaint of hypertensive urgency (unusually high blood pressure that must be lowered). The History and Physical dated [DATE], indicated Assessment and plan: The patient presented to outside hospital with a systolic blood pressure 245 over a diastolic of 100. He had accompanying shortness of breath .on exam he does have bibasilar lung sounds (abnormal) and his blood pressure is markedly elevated .the patient will benefit most from a nephrology (kidney) consult for dialysis as well as titration (to continuously measure) of blood pressure medications . (Normal blood pressure range is less than 120 mm systolic, and less than 80 mm diastolic. Reference from American Heart Association). The nurse's notes indicated on [DATE], at 7:28 a.m., RN 1 notified the physician that Patient 112's blood pressure was ,d+[DATE], and received an order to give Patient 112 the medication Hydralazine (a medication used to lower/control elevated blood pressure). The nurse's note entry for 7:34 a.m., indicated Pt (patient) report given to .RN 5. Pt care transferred .RN 5 aware of new order for Hydralazine IVP (intravenous push - given into a vein). The admission assessment dated [DATE], at 7:30 a.m., indicated .awaiting Hydralizine for elevated B/P (blood pressure). The nurse's notes (late) entry dated [DATE], at 4:40 p.m., indicated 09:58 a.m Found Patient 112 lying on floor with obvious bleeding .SBP ,d+[DATE] . The medication administration record indicated Patient 112 received the medication to lower his elevated blood pressure at 10:36 a.m., three hours and eight minutes after the RN received the order, and 28 minutes after Patient 112 was found on the floor with a head injury. Patient 112 was admitted with diagnoses to include elevated blood pressure. There was a physician's order to give medication to lower Patient 112's blood pressure.The RN did not administer the medication ordered to control Patient 112's blood pressure in a timely manner. Patient 112 was found on the ED bathroom floor with a blood pressure of ,d+[DATE]. The Coroner's investigation report indicated Patient 112 died on [DATE], from a brain hemorrhage which resulted from blunt force head trauma following the fall in the ED on [DATE]. 18918 3. On February 25, 2015, at 10:45 a.m., Registered Nurse (RN) 2 was observed providing care to patients in the Observation Unit. RN 2 was assigned Patient 204, a [AGE] year old transfer from another facility who had undergone a cardiac catheterization on February 24, 2015. RN 2 stated Patient 204 was receiving intravenous antibiotics for treatment of pneumonia. RN 2 administered the medication, then documented in the electronic medical record. RN 2 stated the medication was late, so a note would need to be added to the record. 4. On February 26, 2015, at 9:30 a.m., RN 3 was observed providing care in the Observation Unit. RN 3 stated she had to get Patient 206's medication from the pharmacy as it was not in the unit. RN 3 took the medication to the patient's bedside, scanned the patient's armband, then scanned the medication. As the electronic record did not include instructions for reconstituting the medication, RN 3 called the pharmacy for directions. RN 3 gave the medication as instructed and documented in the medication record. During an interview with the Observation Unit Manager, on February 26, 2015, at 10:10 a.m., the Manager stated they did not have a pyxis refrigerator in the unit, so they had to obtain medications from the pharmacy. In addition, the Manager stated as the patient's were transient (short stay or transfers), daily medications were not sent to the unit. The Manager stated the patient's nurse would call the pharmacy about an hour before the patient's medication was due, to receive the medication.

Violation Name: PHARMACY ADMINISTRATION(A-0491)

• Inspection Date: 2015-02-26 (Event ID: OTPT11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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22764 Based on observation and interview, the facility failed to monitor and store medication in a freezer at the appropriate temperature as specified by the manufacture storage instruction. Temperatures registering outside the manufacturer's storage range and duration could result in the loss of integrity of the medication and potentially harm patients by not providing the expected therapeutic effect. Findings On February 24, 2015, at 3:46 p.m. during an inspection visit to the inpatient pharmacy with the Pharmacy Operations Manager (POM) and the Director of Pharmacy (DPH), the February 2015 temperature log for a freezer in the pharmacy was found posted on its left side. The temperature of the freezer was at -16.8 degree Celsius (C). When first review of the temperature log with the POM, it was noted that there was no temperature recorded for this freezer over the past two days. Further review of the temperature log revealed that the temperature of this freezer was between the ranges of -16 Celsius to -15 C for the first 21 days of this month (February 2015). One of the medications found inside the freezer was Prostin E2 (vaginal suppository medication to help dilate the opening of the uterus (cervix) in a pregnant woman) 20mg. The medication labeling on the box indicated, Store in a freezer not above -20 C. In the interview with the POM and DPH on February 24, 2015, at 3:58 p.m., they acknowledged the temperature of the freezer was improperly set and maintained at a level above the storage condition required by the drug manufacturer. Review of the hospital policy titled, Medication Procurement Storage and Security, on page 2 under Medication Storage, indicated, 2. Medications are stored according to the manufacturer's recommendations .5. Medication contained in refrigerators, freezers and warming Cabinets must be monitored with a functional thermometer and temperatures documented.

Violation Name: DELIVERY OF DRUGS(A-0500)

• Inspection Date: 2015-02-26 (Event ID: OTPT11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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22764 Based on interview and record review, the facility failed to ensure the safe use of fentanyl (opioid pain medication) transdermal patch in accordance with the FDA boxed warning. This failure could potentially expose patients to avoidable life threatening adverse effects of the medication. Findings: Review of the clinical record for Patient 501 on February 26, 2015, with the clinical pharmacy manager (CPM) and Director of Pharmacy (DPH), revealed that he was admitted to the hospital on January 31, 2015, for complaint of worsening shortness of breath. Patient 501 was diagnosed with stage four lung cancer in December 2014, and had a history of tobacco use and chronic obstructive pulmonary disease (COPD). The following narcotic (opioid) pain medications were prescribed for pain relief during his hospital stay: 1. January 31, 2015, Morphine Sulfate 4mg (milligrams) intravenously (IV) every six hours as needed for severe pain; 2. January 31, 2015, Norco 5/325 mg; two tablets by mouth every four hours as needed for moderate pain; 3. February 3, 2015, Morphine Sulfate 15 mg tablet by mouth every 12 hours; and, 4. February 4, 2015, Fentanyl patch 25 mcg (micrograms)/hour; apply one patch every 72 hours. Review of the medication administration record (MAR) with the CPM showed the above opioid medications were administered on the following dates and times: Norco 5 mg was given on February 2, 2015, at 2:54 p.m., and February 3, 2015, at 11:35 a.m.; Morphine sulfate 4mg intravenous (IV) was given on February 3, 2015, 7:28 p.m., and on February 4, 2015, at 12:03 p.m., and at 12:45 p.m. hours; Morphine sulfate 15mg tablet was given on February 3, 2015 at 9:45 a.m., and on February 4, 2015 at 8:58 a.m. Further review of his medication administration record (MAR) also revealed fentanyl 25 mcg/hour transdermal patch (topical narcotic pain relief patch) was later administered on February 4, 2015, at 3:49 p.m., by his nurse. According to the hospital medication reconciliation record dated January 31, 2015, there was no documented evidence that Patient 501 was on any form of opioid pain medication prior to hospital admission. Based on the duration and the amount of opioid exposure prior to administration of the fentanyl patch, Patient 501 was improperly prescribed and subsequently administered a fentanyl patch according to the Food and Drug Adminisration (FDA) boxed warning. The boxed warning for transdermal Duragesic (topical narcotic type pain relief medication; also called fentanyl patches), which the FDA required to be included with all containers of the drug, read, Duragesic (brand name for transdermal fentanyl) is ONLY for use in patients who are already tolerant to opioid (narcotic type pain relief medications) therapy of comparable potency. Use in non-opioid tolerant patients may lead to fatal respiratory depression. Also included in the warning was, Duragesic should ONLY be used in patients who already are receiving opioid therapy who have demonstrated opioid tolerance, and who require a total daily dose at least equivalent to Duragesic 25 mcg/hour. Patients who are considered opioid-tolerant are those who have been taking, for a week or longer, at least 60 mg of morphine (an opioid) daily, or at least 30 mg of oral oxycodone (an opioid) daily, or at least 8 mg of oral hydromorphone (an opioid) daily or an equianalgesic dose of another opioid. During an interview with the CPM and the DPH on February 26, 2015, at 11:43 a.m., they both acknowledged that Patient 501 had not been on the opioid pain medications long enough to be considered opioid tolerant according to the FDA's boxed warning definition.

Violation Name: UNUSABLE DRUGS NOT USED(A-0505)

• Inspection Date: 2015-02-26 (Event ID: OTPT11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** 22764 Based on observation, interview, and record review, the facility failed to ensure potentially deteriorated medication was not available for patient use in the hospital and was stored in accordance with the manufacturer's recommendations. This failure could place patients at risk for treatment failure during episodes of angina (chest pain). Findings: On February 25, 2015, at 2:35 p.m., during an inspection of the medication stocked in room [ROOM NUMBER] of the catheterization laboratory (Cath Lab) with the Pharmacy Operations Manager (POM) and Director of Pharmacy (DPH), eleven bottles of the [NAME] brand intravenous (IV) Nitroglycerin (medication to treat episodes of angina [chest pain] in people who have coronary artery disease [narrowing of the blood vessels that supply the heart]) were stored in a lighted pyxis (automated medication dispensing cabinet) tower, exposed to the light and the heat generated by the lights. The bottles did not have an expiration date other than the manufacturers' date, and the POM was unable to determine if the medication was deteriorated. According to the manufacturer recommendations for nitroglycerin, exposure of the product to heat should be minimized, and it should be protected from light until it's time of use. During an interview with POM on February 25, 2015, at 2:43 p.m., the POM confirmed the IV nitroglycerin bottles in room [ROOM NUMBER] of the Cath Lab were not adequately protected from light after reading the medication label on one of the bottles. He also acknowledged the potency of the medication could have been adversely affected as a result.

Violation Name: INFORMED CONSENT(A-0955)

• Inspection Date: 2015-02-26 (Event ID: OTPT11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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22764 Based on interview and record review, the facility failed to ensure consents for breast localization procedures (inserting a needle to mark the exact location of an abnormality in the breast), performed in the Breast Center, included the side of the intended procedure (which breast). This failed practice resulted in the potential for the localization and subsequent biopsy of the tissue to be performed on the wrong breast, continued growth of abnormal or cancerous breast tissue, and harm or death to the patient. Findings: During a tour of the Breast Center on February 25, 2015, at 10:05 a.m., accompanied by the Regulatory Complaince Manager and the Breast Center Director, the director stated the center performed mammograms and needle localization procedures. The record for Patient 108 was reviewed. Patient 108 underwent a needle localization procedure earlier that morning in preparation for a lumpectomy (removal of a lump) following chemotherapy for right breast cancer. According to the record, Patient 108 had the following history: 1. December 2013, the patient had a bilateral (both sides) mammogram that showed emtremely dense breast tissue with no evidence of malignancy (cancer); 2. June 2014, a right breast mammogram showed extremely dense tissue with a large ill-defined mass. A right breast ultrasound indicated the mass was a suspicious abnormality, and a needle biopsy was recommended; 3. December 2014, a left breast mammogram showed a suspicious abnormality. The radiologist recommended a biopsy of a calcification in the upper outer quadrant of the left breast to rule out malignancy. A left breast ultrasound showed no abnormalities. An addendum to the report indicated the left breast mammogram was compared to previous studies, and the calcifications in the left breast were stable and were likely benign (not cancerous). The radiologist noted that the patient last had a right screening mammogram in June 2014, and recommended she get, back on schedule, for bilateral annual screening. There was no mention of the right breast lump or cancer treatment. The record indicated on February 25, 2015, Patient 108 signed a, Consent To Perform Localization Procedure. The consent did not indicate which breast the procedure would be performed on. During an interview with the Mammography Technician, the technician stated she witnessed the patient signing the consent, and prior to the procedure the consent was compared to the intended procedure. The technician stated the consent form was pre-printed, and did not include which breast the procedure was being performed on for any of the patients who underwent needle localizations in the clinic. The facility policy titled, Consent for Procedures, was reviewed. The policy indicated the consent form must include the name of the procedure, to include the side when indicated.

Violation Name: PATIENT RIGHTS: INFORMED CONSENT(A-0131)

• Inspection Date: 2012-06-14 (Event ID: G7RX11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** 22764 Citation Text for Tag 0131, Regulation FA19 [NAME], [NAME] Based on interview and record review, the hospital failed, for one of five patients who underwent cardiac catheterization (injecting contrast through a catheter into the coronary arteries and heart chambers) (Patient 602) to ensure the physician documented a discussion with the patient (or the patient's representative) regarding information required to make an informed decision prior to the procedure. This failure resulted in the potential for patients to undergo procedures without the necessary information needed to give a truly informed consent. Findings: The record for patient 602 was reviewed on June 12, 2012, at 1 p.m. Patient 602, a [AGE] year old female, underwent cardiac catheterization by physician D on May 22, 2012. The record contained a standard procedural consent form signed by the patient and witnessed by a nurse, but no documentation by the physician of a discussion between himself and the patient regarding the risks, benefits, alternatives, and likelihood of success for the procedure. The [NAME] President of Quality reviewed the chart and agreed the record lacked evidence of informed consent by the physician.

Violation Name: INFORMED CONSENT(A-0955)

• Inspection Date: 2012-06-14 (Event ID: G7RX11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** 22764 Citation Text for Tag 0955, Regulation FA19 [NAME], [NAME] Based on interview and record review, the hospital failed, for one of five patients who underwent cardiac catheterization (injecting contrast through a catheter into the coronary arteries and heart chambers) (Patient 602) to ensure the physician documented a discussion with the patient (or the patient's representative) regarding information required to make an informed decision prior to the procedure. This failure resulted in the potential for patients to undergo procedures without the necessary information needed to give a truly informed consent. Findings: The record for patient 602 was reviewed on June 12, 2012, at 1 p.m. Patient 602, a [AGE] year old female, underwent cardiac catheterization by physician D on May 22, 2012. The record contained a standard procedural consent form signed by the patient and witnessed by a nurse, but no documentation by the physician of a discussion between himself and the patient regarding the risks, benefits, alternatives, and likelihood of success for the procedure. The [NAME] President of Quality reviewed the chart and agreed the record lacked evidence of informed consent by the physician.

Violation Name: MEDICAL STAFF QUALIFICATIONS(A-0357)

• Inspection Date: 2011-10-21 (Event ID: NDK111)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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22764 Based on interview and record review for one surgeon who was actively performing surgeries, (Surgeon 1), the facility failed to identify specific privileges that were being granted, and failed to document the reason for the department chair not signing the form. This failure created the risk of a substandard surgical outcome for patients treated by Surgeon 1. Findings: During a review of the credential file of Surgeon 1, a pre-printed Request for Clinical Privileges form dated October 27, 2010, was viewed with many privileges requested, designated with written check marks, however the adjacent columns for granting or denying the procedures was left blank. The second page of the form, likewise, had blank columns for granting or denying privileges. The signature line for the chair of cardiovascular surgery to sign was left blank, but the form was signed by the Chairman of the Surgical Department on February 15, 2011, and approved by the Med Exec and the Board of Directors.

Violation Name: NURSING SERVICES(A-0385)

• Inspection Date: 2011-10-21 (Event ID: NDK111)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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22764 Based on interview and record review, the facility failed to ensure that cardiovascular operating room personnel were trained and competent in cardiovascular thoracic procedures, including the use of cardiovascular equipment and supplies, resulting in the potential to cause a delay in providing patient care, the risk of a poor surgical outcome, and substandard care for all patients undergoing cardiovascular surgery in the facility (A397). The cumulative effect of these systemic problems resulted in the failure of the facility to ensure nursing services were provided in a safe and effective manner.

Violation Name: PATIENT CARE ASSIGNMENTS(A-0397)

• Inspection Date: 2011-10-21 (Event ID: NDK111)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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22764 Based on interview and record review, the facility failed to ensure that cardiovascular operating room personnel were trained and competent in cardiovascular thoracic procedures, including the use of cardiovascular equipment and supplies, resulting in the potential to cause a delay in providing patient care, the risk of a poor surgical outcome, and substandard care for all patients undergoing cardiovascular surgery in the facility. Findings: 1. An interview was conducted with the surgery nurse educator on October 6, 2011, at 9:15 a.m The surgery nurse educator stated the resource nurse for cardiovascular surgery was out on leave. The nurse educator stated RN 224 had been training on the CVOR team for about one and one half months. The nurse educator stated another nurse on the team, RN 225, had no heart experience, and the Director was aware of this. A third nurse, RN 226, going through training on the cardiovascular team, was new. The surgery nurse educator stated the doctors were telling the staff that they did not know what they were doing. She stated it had gotten worse, and the doctors did not have patience with the staff. She stated the CVOR nurses were feeling like they were incompetent. She stated some nurses had recently asked for more education in heart surgery. The surgery nurse educator stated the cardiovascular surgeons did not provide education or inservice to the cardiovascular team. She stated she was not a CVOR nurse and she was not able to determine the competency of the CVOR staff. 2. During an interview on October 6, 2011, at 10:40 a.m., RN 228 stated one nurse, who said she had experience in cardiovascular surgery, was thrown into a case but did not know sterility, how to insert a urinary catheter, or how to prep for a heart procedure. RN 228 stated the heart was a critical area and they must have high standards. RN 228 stated they were looking for experienced nurses because the doctors had no patience and didn't want to teach new staff. 3. On October 6, 2011, the CVOR team personnel files for five RNs and four STs were reviewed. Two of the five RN files (RNs 224 and 225) had no documentation of CVOR competencies. Another RN (RN 226) had the CVOR competency extended due to identified weaknesses in her job performance. The ST's files indicated one of the four STs (ST 221) was still being checked off for CVOR competency and was still in orientation. ST 222 had not been checked off for CVOR competency since his hire date of August 2008, but he was doing cases independently. In a concurrent interview at 3:40 p.m., the surgery nurse educator stated ST 222 was one of two experienced STs, and ST 222 was the mentor for recently hired ST 221. One traveler ST (ST 223) had no CVOR competency verification in the personnel file. During an interview on October 6, 2011, at 3:40 p.m., the surgery nurse educator stated, I did not do a CVOR competency for him because he's only here for 13 weeks. 4. On October 19, 2011, at 8 a.m., Surgeon 3, Section Chief of Cardiovascular Surgery Services, was interviewed. Surgeon 3 stated he would desire competency of the OR to be better. He stated, It gets very ugly and frustrating, the patient's life is at hand, lack of knowledge and training can cause longer pump (on bypass) time. 5. On October 19, 2011, at 9:45 a.m., Surgeon 1 stated the turnover of nurses resulted in the lack of CVOR trained nurses, and there was a similar problem with the STs. 6. During an interview on October 20, 2011, at 1:25 p.m., the Director of Perioperative Services stated the cardiovascular surgeons were not currently involved in training of the CVOR staff. The Director stated, I don't know if the staff that helps in the cardiovascular room is trained. 6. During an interview with Surgeon 1 on October 20, 2011, at 10:30 a.m., Surgeon 1 stated the OR staff was inexperienced, did not have established competency, and there was only one experienced scrub tech. He stated there had been episodes when the circulating nurse was not able to identify the instruments needed. He stated he had tried to call the problems to the attention of the Director of Perioperative Services, Chief of Surgery, and Chief of the Medical Staff, but his concerns fell on deaf ears. 7. During an interview with the Chief of Medical Staff on October 21, 2011, at 8:35 a.m., he stated Surgeon 1 approached him regarding the limited capabilities of the CVOR staff. 8. During an interview with the VPQ on October 21, 2011, at 10:05 a.m., she stated she was not aware of the problems with staff competency in cardiovascular surgery. 9. The facility policy, Competency Program, revised August 2009, read in part, The Hospital provides an adequate number of staff members whose competencies are consistent with job responsibilities. The Directors/Managers ensure that the competence of all staff members is continually assessed, maintained, demonstrated, and improved. 10. An interview was conducted with the director of surgery on October 20, 2011, at 1 p.m. The Director of Perioperative Services stated she had two cardiovascular teams available. She stated each team consisted of two RNs and one OR technician. The cardiovascular staffing schedule was reviewed with the director. There were several days that only had two or three nurses scheduled to work. The director stated she could, pull nurses from the main OR, to make a heart team if needed. The director, when asked if the nurses she was pulling to create a team for cardiovascular surgery were competent to do the job, stated, I'm not sure. A list of the OR nurses that were pulled from the main OR to create the cardiovascular surgery team for emergency surgeries, was requested. The director provided a list with four names on it (RNs 237, 238, 239, and 240). All four RN's personnel and training records were reviewed. There was no record of any competencies for cardiovascular surgeries present for any of the four nurses. An interview was conducted with the OR educator on October 21, 2011, at 10 a.m. The educator stated the four RNs whose names the director provided were not trained and did not have competencies for cardiovascular surgery. The educator stated cardiovascular surgery was a specialty that required additional training. She stated the nurses had been asking for the training for a while, but it had been very difficult to schedule the training for the nurses because they were often short staffed. The educator stated there had been times when the nurses were scheduled to take a training class, and then were called out of the course because they were needed for surgery. The OR educator stated it had been very frustrating for everyone. 11. An interview was conducted with the Director of Perioperative Services on October 21, 2011, at 11:50 a.m. The director stated she recognized about six to eight months ago, that the OR cardiovascular nurses were lacking competencies in cardiovascular procedures. The director stated she was aware that the four nurses she had been using to create the additional cardiovascular surgery team did not have cardiovascular competencies. She stated she used those nurses because they had been in the OR the longest. 12. A confidential group interview was conducted with OR staff members on October 19, 2011, starting at 2 p.m The OR staff members expressed their frustration and concerns about a very tense and punitive working environment. The staff members stated, because they were usually short staffed, there was no time given for training. They stated, We need help.

Violation Name: GOVERNING BODY(A-0043)

• Inspection Date: 2011-10-21 (Event ID: NDK111)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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22764 Based on interview and record review, the Governing Body failed to ensure the facility functioned effectively, by failing to: 1. Ensure compliance with licensing requirements to operate a cardiovascular service in the State of California (A020); 2. Develop, implement, and maintain a QAPI program to ensure the quality and safety of surgical services offered by the cardiovascular surgery section (A263); 3. Ensure the Medical Staff was responsible and accountable for the quality of medical care provided to the patients (A338); and, 4. Ensure the competency of nursing staff on the cardiovascular surgery team (A397). The cumulative effect of these systemic problems resulted in failure to ensure medical and nursing care was provided in a safe and effective manner.

Violation Name: COMPLIANCE WITH LAWS(A-0020)

• Inspection Date: 2011-10-21 (Event ID: NDK111)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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22764 Based on interview and record review, the facility failed to meet the requirements of licensure according to: 1. CCR, Title 22, º70435(b)(2) by failing to ensure that the requirement for having three surgeons (two with a program flex) being present during cardiac surgery with extracorporeal bypass, were met (A022); 2. CCR, Title 22, º70435(b)(1) by failing to ensure that the chief of the cardiovascular surgery service participated in training nursing staff to be competent to staff cardiovascular surgeries (A022); and, 3. CCR, Title 22, º70435(d) by failing to ensure that the cardiovascular surgical service was available at all times for emergencies (A022). The cumulative effect of these systemic problems resulted in the failure of the facility to ensure compliance with licensing requirements, to operate a cardiovascular service in the State of California.

Violation Name: LICENSURE OF HOSPITAL(A-0022)

• Inspection Date: 2011-10-21 (Event ID: NDK111)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** 22764 Based on interview and record review, the facility failed to meet the requirements for licensing as a cardiovascular service according to: 1. CCR, Title 22, º70435(b)(2) by failing to ensure for five of ten patients reviewed, that the requirement for having three surgeons present (two surgeons with an approved program flex) during cardiac surgery with extracorporeal bypass, were met (Patients 103, 107, 110, 203, and 216) (A022); 2. CCR, Title 22, º70435(b)(1) by failing to ensure that the chief of the cardiovascular surgery service participated in training nursing staff to be competent to staff cardiovascular surgeries (A022); and, 3. CCR, Title 22, º70435(d) by failing to ensure that the cardiovascular surgical service was available at all times for emergencies (A022). These failures resulted in the inability to ensure compliance with licensing requirements to operate a cardiovascular service in the State of California, and the potential for substandard health outcomes for all patients having cardiovascular surgery at the facility. Findings: 1. According to CCR, Title 22, º70435 (b)(2), a minimum of three surgeons shall constitute a surgical team for the performance of all cardiovascular operative procedures which require extracorporeal bypass. A program flex was issued by the Department on December 9, 1994, which allowed the facility to perform cardiovascular operative procedures requiring extracorporeal bypass with a minimum of two surgeons. (Extracorporeal bypass is a technique that temporarily takes over [bypasses] the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the body). a. The record for Patient 103 was reviewed on October 18, 2011. Patient 103, a [AGE] year old female, was admitted on [DATE], with diagnoses that included thoracic aortic aneurysm (a weakened and bulging area in the upper part of the aorta, the major blood vessel that feeds blood to the body). The patient underwent a repair of the aneurysm (a procedure that required extracorporeal bypass) on June 20, 2011. According to the Perfusionist Record, the patient was placed on bypass at 10:16 a.m., and taken off of bypass at 1:48 p.m. According to the Intraoperative Nurse's Notes, the assistant surgeon entered the operating room at 9:59 a.m., left the room at 12:58 p.m., and re-entered the room at 2:26 p.m. The assistant surgeon was out of the room for 29 minutes while the patient was on bypass. b. The record for Patient 107 was reviewed on October 18, 2011. Patient 107, a [AGE] year old male, was admitted to the facility on [DATE], with diagnoses that included CAD. The patient underwent four vessel CABG surgery (veins from elsewhere in the body are attached to the coronary arteries to bypass blockages and improve the blood supply to the heart) on July 14, 2011. According to the Perfusionist Record, the patient was placed on bypass at 3:46 p.m., and taken off of bypass at 5:17 p.m. According to the Intraoperative Nurse's Notes, the assistant surgeon entered the operating room at 3:27 p.m., left the room at 4:35 p.m., and did not return. The assistant surgeon was out of the room for 42 minutes while the patient was on bypass. c. The record for Patient 110 was reviewed on October 20, 2011. Patient 110, a [AGE] year old male, was admitted to the facility on [DATE], with diagnoses that included [NAME] (heart attack), severe CAD, and severe aortic valve regurgitation (the heart's aortic valve was not closing tightly). The patient underwent emergency three vessel CABG surgery and aortic valve replacement on August 22, 2011. According to the Perfusionist Record, the patient was placed on bypass on August 22, 2011, at 11:01 p.m., and taken off of bypass on August 23, 2011, at 1:44 a.m. According to the Intraoperative Nurse's Notes, the assistant surgeon entered the operating room on August 22, 2011, at 10:30 p.m., left the room on August 23, 2011, at 12:35 a.m., and did not return. The assistant surgeon was out of the room for one hour and nine minutes while the patient was on bypass. d. On October 6, 2011, the record for Patient 203 was reviewed. Patient 203, a [AGE] year old male, was admitted to the facility on [DATE], with diagnoses including mitral valve disorder (nonfunctioning valves between the left heart chambers) and coronary atherosclerosis (inflammatory disease with fibrous tissue or plaque on the walls of coronary arteries that supplies heart muscle). Patient 203 had surgery on July 8, 2011. The documentation on the perioperative record indicated the procedures performed included, Redo Sternotomy (incision into chest), CABG (bypass surgery), [NAME] procedure (surgical procedure using incisions to form a [NAME] through which impulses can travel to treat irregular electrical activity of the upper chambers of the heart), Mitral Valve repair/replace. The following start and stop times were indicated in the operative record: Anesthesia start: 7:32 a.m. Anesthesia end: 4:36 p.m. Surgery start: 9 a.m. Surgery end: 4:31 p.m. Assisting Surgeon: Time In: 9:30 a.m. / Time Out: 12:55 p.m.; and, Time In: 2:35 p.m. / Time Out: 4:27 p.m. Perfusion Time: 11:47 a.m. to 3:06 p.m.; a total of 3 hours and 19 minutes. The assisting surgeon, Surgeon 4, arrived in the operating room [ROOM NUMBER] minutes after the surgery began. Surgeon 4 left the operating room between 12:55 p.m. and 2:35 p.m., for one hour and 40 minutes, while the patient was on bypass. On October 6, 2011, at 2:15 p.m., the Perioperative Services Director stated she was upset when she heard Surgeon 4 was out of the room, and stated administration had been notified. The Director could not confirm the situation had been resolved. e. On October 21, 2011, Patient 216's record was reviewed. Patient 216 was admitted on [DATE], with diagnoses including aortic insufficiency (inadequate blood supply to the largest artery in the body), status post aortic valve replacement. Patient 216 had surgery on September 22, 2011, for aortic valve replacement and repair of an ascending aortic aneurysm. The following start and stop times were indicated on the perioperative record: Anesthesia start: 7:45 a.m. Anesthesia end: 2:10 p.m. Surgery start: 8:52 a.m. Surgery end: 1:41 p.m. Assisting Surgeon: Time In: 8:25 a.m. / Time Out: 9:40 a.m., Time In: 10:34 a.m. / Time Out: 12:09 p.m.; and, Time In: 12:32 p.m. / Time Out: 1 p.m. Perfusion Time: 10:13 a.m. to 12:29 p.m.; a total of 2 hours and 41 minutes. The assisting surgeon (Surgeon 4) arrived in the operating room [ROOM NUMBER] minutes after the bypass pump was on and left the room [ROOM NUMBER] minutes before the bypass pump was off. Assisting Surgeon 4 was out of the room for 41 minutes while the pump was on. On October 6, 2011, at 10:20 a.m., Nurse 228 stated, .not always two surgeons in the room. I document when they leave the room and when they come back. I go straight to the managers. I tell them you have to be here, you are jeopardizing the patients . On October 6, 2011, at 10:25 a.m., Nurse 227 stated, We have to document, otherwise we will be fired. There was an ascending aortic aneurysm surgery, I wrote an incident, only the PA (was) left in room while the patient was warming, (Physician 232) left. I called the charge nurse, the charge nurse called the manager, the manager called the director. The doctor was gone for 12 minutes. There is too much in and out for doctors. It has always been the practice. During an interview on October 6, 2011, at 7:50 a.m., the Director of Perioperative Services stated the scheduler had a grid in the scheduling policy indicating which cases needed an assistant. During an interview with the Director of Perioperative Services on October 20, 2011, at 1:05 p.m., she stated the nurses reported to her that the assisting cardiovascular surgeons were leaving the room while the patients were on the bypass pump. During an interview with Surgeon 2 (a cardiovascular surgeon) on October 21, 2011, at 2:30 p.m., he stated it was not uncommon for a surgeon to leave the room during the rewarming process (while the patient was still on bypass). The Medical Staff Bylaws were reviewed on October 20, 2011. The preamble of the bylaws indicated members of the medical staff at the facility were expected to follow state laws applicable to the practice of medicine. The Medical Staff Rules and Regulations were reviewed on October 20, 2011. The rules and regulations indicated the operating surgeon must have an assistant at all major operations designated by the department. The Surgical Department Rules and Regulations were reviewed on October 20, 2011. The rules and regulations indicated each section would be responsible for listing the procedures where a surgical specialist was required as an assistant. The surgical department policy titled, Assistants During Cardiovascular Surgery, was reviewed on October 20, 2011. The policy indicated a qualified assistant surgeon would be present for cardiovascular surgical cases while the patient was on extracorporeal bypass. 2. According to CCR, Title 22, º70435(b)(1), a physician shall have overall responsibility for the cardiovascular service. This physician shall be responsible for training and supervising the nurses and technicians in special techniques. During an interview with the Director of Perioperative Services on October 20, 2011, at 1:05 p.m., she stated Surgeon 3 (the cardiovascular surgery section chief) was not involved in training of the OR staff. During an interview with the COO on October 20, 2011, at 1:20 p.m., he stated the chief of the cardiovascular surgery service (Surgeon 3) was not contributing to training the OR staff. 3. According to CCR, Title 22, º70435(d), the cardiovascular surgical service shall be available at all times for emergencies. During an interview with the Director of Perioperative Services on October 20, 2011, at 1:05 p.m., she stated she was not sure if staff being used as the cardiovascular second team were trained to participate in cardiovascular surgeries. She stated that CVOR staff frequently worked late and were not available to act as on call staff due to their union contract, although they were scheduled to be on call. In an interview conducted on October 19, 2011, at 9:15 a.m., Surgeon 1 stated the hospital was a STEMI Center and should have two cardiovascular teams available. He stated they did not have two teams and had to, Scramble with anesthesia and staff to find a team if there was an emergency. Surgeon 1 further stated they had to postpone morning cases because nurses had worked the night before and there was only one heart team. He stated the team varied from day to day and they may not have the ability to do the cases coming in to the ER. The nursing union contract was reviewed on October 19, 2011. The contract indicated the nursing staff was entitled to an eight hour break every 24 hour period. The contract indicated the staff did not have to respond to an emergency if they did not have their eight hour break.

Violation Name: MEDICAL STAFF(A-0338)

• Inspection Date: 2011-10-21 (Event ID: NDK111)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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22764 Based on interview and record review, the facility failed to: 1. Ensure the integrity of the appraisal process for two surgeons (Surgeons 1 and 5), creating the risk of substandard services being provided to all patients receiving services from those surgeons (A340); 2. Ensure the medical staff was accountable to the governing body for the quality of patient care provided, by failing to: a. Ensure physicians conducted themselves in a professional and cooperative manner during surgical procedures, resulting in the potential for errors to be made by staff (A347); and, b. Ensure members of the medical staff were in compliance with their Rules and Regulations, Surgical Department Rules and Regulations, and the facility policy requiring two surgeons to be present in the operating room during cardiovascular surgery requiring bypass, resulting in the potential for harm to patients undergoing cardiovascular surgery (A347); 3. Ensure enforcement of their bylaws by failing to ensure an adequate and effective peer review process was completed for one surgeon (Surgeon 1), resulting in the potential for poor health outcomes for the surgeon's patients (A353); 4. Obtain a list of requested privileges for one surgeon (Surgeon 5) who was acting as an assisting surgeon. The facility failed to identify all of the types of surgeries Surgeon 5 was planning to assist with, and allowed him to be scheduled to assist with surgeries for which he was not privileged, resulting in the risk of substandard surgical outcomes for patients having surgery with Surgeon 5 as the assisting surgeon (A355); and, 5. Identify specific privileges for one surgeon (Surgeon 1) who was actively performing cardiovascular surgeries, and to document the reason for the department chair not recommending granting of the privileges, resulting in the risk of a substandard surgical outcome for patients treated by Surgeon 1 (A355). The cumulative effect of these systemic problems resulted in the failure to ensure that patients at the facility were receiving safe and effective medical care by physicians.

Violation Name: MEDICAL STAFF PERIODIC APPRAISALS(A-0340)

• Inspection Date: 2011-10-21 (Event ID: NDK111)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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22764 Based on interview and record review, the facility failed to ensure the integrity of the appraisal process for two surgeons (Surgeons 1 and 5), resulting in the risk of substandard services being provided to all patients receiving services from those surgeons. Findings: 1. During a review of the credential file for Surgeon 1 on October 21, 2011, the periodic performance evaluation data was reviewed, and a discrepancy between the data recorded on October 18, 2010, and that documented on the data summary form dated November 10, 2010, was noted. During a concurrent interview with the Director of Medical Staff, she reviewed the October 18, 2010, quality data and the November 10, 2010, summary form for the data in Surgeon 1's file. The Director of Medical Staff stated it looked like the data regarding concerns about Surgeon 1 had, in error, not been carried forward to the summary form, which was one of the documents reviewed at the time of Surgeon 1's last reappointment. 2. During a review of the credential file for Surgeon 5 on October 18, 2011, there were two letters of reference noted in the file for his last reappointment. During a concurrent interview of the Medical Staff Assistant, she stated the facility required three letters of reference for physician reappointment. She was unable to explain why only two letters of reference were seen for Surgeon 5's 2011 reappointment.

Violation Name: MEDICAL STAFF ORGANIZATION & ACCOUNTABILITY(A-0347)

• Inspection Date: 2011-10-21 (Event ID: NDK111)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** 22764 Based on interview and record review, the facility failed to ensure that the medical staff was accountable to the governing body for the quality of patient care provided, by failing to: 1. Ensure physicians conducted themselves in a professional and cooperative manner during surgical procedures, resulting in the potential for errors to be made by staff; and, 2. Ensure members of the medical staff were in compliance with their Rules and Regulations, Surgical Department Rules and Regulations, and the facility policy requiring two surgeons to be present in the operating room during cardiovascular surgery requiring bypass, resulting in the potential for harm to patients undergoing cardiovascular surgery. Findings: 1a. The Medical Staff Bylaws were reviewed on October 20, 2011. Section 2 indicated successful candidates for clinical privileges must adhere to professional and cooperative behavior, and demonstrate their ability to work with others with sufficient adequacy to assure the Board of Directors that any patient treated by them in the hospital would be given a high quality of medical care. The Medical Staff Rules and Regulations were reviewed on October 20, 2011. The rules and regulations indicated unacceptable physician behavior would be dealt with according to the Medical Staff Physician/AHP Behavior Policy. The Medical Staff Physician/AHP Behavior policy was reviewed on October 6 and 20, 2011. The policy indicated the following: aa. All physicians and AHPs were required to conduct themselves in a professional manner; bb. To ensure quality care, the medical staff leadership produced the policy to provide a process to identify and address individual practitioner behavior that was not conducive to quality patient care, including a high level of service and teamwork; cc. Interdisciplinary communication/interaction issues (defined as behavior that was disruptive [e.g. unprofessional interactions with staff]) would be investigated, with the results of the investigation referred to the department/section chairman for review and adjudication; and, dd. An identified pattern or trend, defined as five or greater incidents in a rolling six month period, would be referred to the president of the medical staff. 1b. A confidential group interview was conducted with OR staff members on October 19, 2011, starting at 2 p.m. The OR staff members expressed their frustration and concerns about a very tense and punitive working environment. The following were issues the staff members stated were occurring in the OR: aa. hesitation to be trained for cardiovascular surgery due to unprofessional treatment by the physicians; and, bb. failure of management to follow up on reports of physician behavior; 1c. A facility report was reviewed on October 20, 2011, indicating Surgeon 1 was yelling and being verbally abusive. The note on the report indicated it was sent to the medical staff on July 27, 2011, but no investigation or discussion with Surgeon 1 was documented. During an interview with the Director of Risk Management on October 21, 2011, at 10 a.m., the Director of Risk Management stated she would have expected the incidents involving the OR to be investigated and the physician(s) interviewed, but she did not see evidence of such investigations. During an interview with the Director of Perioperative Services on October 21, 2011, at 11 a.m., the Director stated she routed the reports to the medical staff and QA, but she did not investigate or ask anyone else to investigate the incidents. She stated she thought QA or the medical staff would do the investigation. She stated she did not recall any training in how the reports were to be handled by facility management staff. 2. The Medical Staff Rules and Regulations were reviewed on October 20, 2011. The rules and regulations indicated the operating surgeon must have an assistant at all major operations designated by the department. The Surgical Department Rules and Regulations were reviewed on October 20, 2011. The rules and regulations indicated each section would be responsible for listing procedures that a surgical specialist was required as an assistant. The surgical department policy titled, Assistants During Cardiovascular Surgery, was reviewed on October 20, 2011. The policy indicated a qualified assisting surgeon would be present for cardiovascular surgical cases while the patient was on extracorporeal bypass. (Extracorporeal bypass is a technique that temporarily takes over [bypasses] the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the body). A memorandum from the Chairman of the Surgical Department dated September 21, 2011, and a letter dated October 7, 2011, from the Medical Director of Perioperative Services both advised the medical staff that surgical assistants were to remain present during cardiovascular surgery until the portion of the surgery requiring bypass was completed. a. The record for Patient 103 was reviewed on October 18, 2011. Patient 103, a [AGE] year old female, was admitted on [DATE], with diagnoses that included thoracic aortic aneurysm (a weakened and bulging area in the upper part of the aorta, the major blood vessel that feeds blood to the body). The patient underwent a repair of the aneurysm (a procedure that required extracorporeal bypass) on June 20, 2011. According to the Perfusionist Record, the patient was placed on bypass at 10:16 a.m., and taken off of bypass at 1:48 p.m. According to the Intraoperative Nurse's Notes, the assisting surgeon entered the operating room at 9:59 a.m., left the room at 12:58 p.m., and re-entered the room at 2:26 p.m. The assisting surgeon was out of the room for 29 minutes while the patient was on bypass. b. The record for Patient 107 was reviewed on October 18, 2011. Patient 107, a [AGE] year old male, was admitted to the facility on [DATE], with diagnoses that included CAD. The patient underwent four vessel CABG surgery (veins from elsewhere in the body are attached to the coronary arteries to bypass blockages and improve the blood supply to the heart) on July 14, 2011. According to the Perfusionist Record, the patient was placed on bypass at 3:46 p.m., and taken off of bypass at 5:17 p.m. According to the Intraoperative Nurse's Notes, the assisting surgeon entered the operating room at 3:27 p.m., left the room at 4:35 p.m., and did not return. The assisting surgeon was out of the room for 42 minutes while the patient was on bypass. c. The record for Patient 110 was reviewed on October 20, 2011. Patient 110, a [AGE] year old male, was admitted to the facility on [DATE], with diagnoses that included [NAME] (heart attack), severe CAD, and severe aortic valve regurgitation (the heart's aortic valve was not closing tightly). The patient underwent emergency three vessel CABG surgery and aortic valve replacement on August 22, 2011. According to the Perfusionist Record, the patient was placed on bypass on August 22, 2011, at 11:01 p.m., and taken off of bypass on August 23, 2011, at 1:44 a.m. According to the Intraoperative Nurse's Notes, the assisting surgeon entered the operating room on August 22, 2011, at 10:30 p.m., left the room on August 23, 2011, at 12:35 a.m., and did not return. The assisting surgeon was out of the room for one hour and nine minutes while the patient was on bypass. d. On October 6, 2011, the record for Patient 203 was reviewed. Patient 203, a [AGE] year old male, was admitted to the facility on [DATE], with diagnoses including mitral valve disorder (nonfunctioning valves between the left heart chambers) and coronary atherosclerosis (inflammatory disease with fibrous tissue or plaque on the walls of coronary arteries that supplies heart muscle). Patient 203 had surgery on July 8, 2011. The documentation on the perioperative record indicated the procedures performed included, Redo Sternotomy (incision into chest), CABG (bypass surgery), [NAME] procedure (surgical procedure using incisions to form a [NAME] through which impulses can travel to treat irregular electrical activity of the upper chambers of the heart), Mitral Valve repair/replace. The following start and stop times were indicated in the operative record: Anesthesia start: 7:32 a.m. Anesthesia end: 4:36 p.m. Surgery start: 9 a.m. Surgery end: 4:31 p.m. Assisting Surgeon: Time In: 9:30 a.m. / Time Out: 12:55 p.m.; and, Time In: 2:35 p.m. / Time Out: 4:27 p.m. Perfusion Time: 11:47 a.m. to 3:06 p.m.; a total of 3 hours and 19 minutes. The assisting surgeon, Surgeon 4, arrived in the operating room [ROOM NUMBER] minutes after the surgery began. Surgeon 4 left the operating room between 12:55 p.m. and 2:35 p.m., for one hour and 40 minutes, while the patient was on bypass. On October 6, 2011, at 2:15 p.m., the Perioperative Services Director stated she was upset when she heard Surgeon 4 was out of the room, and stated administration had been notified. The Director could not confirm the situation had been resolved. e. On October 21, 2011, Patient 216's record was reviewed. Patient 216 was admitted on [DATE], with diagnoses including aortic insufficiency (inadequate blood supply to the largest artery in the body), status post aortic valve replacement. Patient 216 had surgery on September 22, 2011, for aortic valve replacement and repair of an ascending aortic aneurysm. The following start and stop times were indicated on the perioperative record: Anesthesia start: 7:45 a.m. Anesthesia end: 2:10 p.m. Surgery start: 8:52 a.m. Surgery end: 1:41 p.m. Assisting Surgeon: Time In: 8:25 a.m. / Time Out: 9:40 a.m., Time In: 10:34 a.m. / Time Out: 12:09 p.m.; and, Time In: 12:32 p.m. / Time Out: 1 p.m. Perfusion Time: 10:13 a.m. to 12:29 p.m.; a total of 2 hours and 41 minutes. Assisting surgeon (Surgeon 4) arrived in the operating room [ROOM NUMBER] minutes after the bypass pump was on and left the room [ROOM NUMBER] minutes before the bypass pump was off. Assisting Surgeon 4 was out of the room for 41 minutes while the pump was on. On October 6, 2011, at 10:20 a.m., Nurse 228 stated, .not always two surgeons in the room. I document when they leave the room and when they come back. I go straight to the managers. I tell them you have to be here, you are jeopardizing the patients . On October 6, 2011, at 10:25 a.m., Nurse 227 stated, We have to document, otherwise we will be fired. There was an ascending aortic aneurysm surgery, I wrote an incident, only the PA (was) left in room while the patient was warming, (Physician 232) left. I called the charge nurse, the charge nurse called the manager, the manager called the director. The doctor was gone for 12 minutes. There is too much in and out for doctors. It has always been the practice. During an interview on October 6, 2011, at 7:50 a.m., the Director of Perioperative Services stated the scheduler had a grid in the scheduling policy indicating which cases needed an assistant. During an interview with the Director of Perioperative Services on October 20, 2011, at 1:05 p.m., she stated the nurses reported to her that the assisting cardiovascular surgeons were leaving the room while the patients were on the bypass pump. During an interview with Surgeon 2 (a cardiovascular surgeon) on October 21, 2011, at 2:30 p.m., he stated it was not uncommon for a surgeon to leave the room during the rewarming process (while the patient was still on bypass).

Violation Name: MEDICAL STAFF BYLAWS(A-0353)

• Inspection Date: 2011-10-21 (Event ID: NDK111)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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22764 Based on interview and record review, the Medical Staff failed to ensure the enforcement of the bylaws, by failing to ensure an adequate and effective peer review process was completed for one surgeon (Surgeon 1), resulting in the potential for poor health outcomes for the surgeon's patients. Findings: During an interview with the VPQ on October 18, 2011, at approximately 10 a.m., the VPQ stated an external review had been done on 12 cases performed by Surgeon 1, that resulted in the patient leaving the operating room after open heart surgery with an open chest (temporarily leaving the chest cavity open rather than sewing it shut). The VPQ stated all of the cases had been found by the outside reviewers to be appropriate care. During a review of the January 26, 2011, presentation by Surgeon 3 to the CT Surgery Committee, regarding the external peer review of the 12 cases performed by Surgeon 1, there was no mention in the summary of the presentation that the cases were found to be appropriate care. During a review of the February 9, 2011, presentation by Surgeon 3 to the Surgical QRC, regarding the external peer review of the 12 cases performed by Surgeon 1, there was no mention in the summary of the presentation that the cases were found to be appropriate care. During an interview with the VPQ on October 21, 2011, at approximately 3 p.m., she stated there was no handout with full results of the outside reviews, including the fact that the cases were found to be appropriate care, provided to committee attendees. During a review of the February 17, 2011, discussion with the Surgical QRC regarding the outside peer review of 12 cases performed by Surgeon 1, there was no presentation of the external peer review seen. The Bylaws of the Medical Staff dated January 2010, were reviewed. Article X, Section 4B4 indicated the duties of sections included meeting to discuss specific issues related to performance improvement, peer review, and/or credentialing, and the Section would report their findings directly to the Department Chairman and/or relevant QRC. However, documentation of a full discussion of the results of the external peer review with the Surgical QRC, including the care by Surgeon 1 that was found to be appropriate, was not present. During a review of the credential file for Surgeon 1 on October 19, 2011, at 3:05 p.m., Surgeon 1 had a case reviewed internally on January 24, 2011. The Medical Staff sent a letter on August 18, 2011, to Surgeon 1 as a result of the peer review, asking Surgeon 1 to complete a discharge summary on the case. No evidence of completion of the request was found in the file, and no follow-up contact was documented. During an interview with the VPQ on October 19, 2011, at 3:05 p.m., she stated there was no apparent follow-up to the peer review of Surgeon 1. She stated a letter of explanation from Surgeon 1 had been requested, but was not received, and no follow-up of the issue was seen. The VPQ was not able to explain why follow-up had not occurred.

Violation Name: MEDICAL STAFF PRIVILEGING(A-0355)

• Inspection Date: 2011-10-21 (Event ID: NDK111)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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22764 Based on interview and record review, the facility failed to: 1. Obtain a list of requested privileges for one surgeon (Surgeon 5) who was acting as an assisting surgeon. The facility failed to identify all of the types of surgeries that Surgeon 5 was planning to assist with, and allowed him to be scheduled to assist with surgeries for which he was not privileged. These failures resulted in the risk of substandard surgical outcomes for patients having surgery with Surgeon 5 as the assisting surgeon; and, 2. Identify specific privileges for one surgeon (Surgeon 1) who was actively performing cardiovascular surgeries, and to document the reason for the department chair not recommending granting of the privileges. These failures resulted in the risk of a substandard surgical outcome for patients treated by Surgeon 1. Findings: 1. During a review of the credential file of Surgeon 5, the documentation contained a note with the application indicating he wished to be of assistance to any surgeon who would benefit from his assistance. There was no specific request for privileges as a surgical assistant in any specific type of surgery. During an interview with the Medical Staff Assistant on October 18, 2011, at 2:50 p.m., she reviewed the file and stated she was not able to determine which privileges had been approved. During a review of the surgery schedule for October 18, 2011, Surgeon 5 was scheduled to assist Surgeon 1 in a cardiovascular (open heart surgery) case. During an interview with Surgeon 1 on October 20, 2011, at 10:30 a.m., he stated Surgeon 5 assisted him in the majority of his cardiovascular cases. The electronic list of privileges granted to Surgeon 5, reviewed with the Surgery Scheduler on October 18, 2011, was limited to neurosurgery assisting surgeon privileges. The Medical Staff Bylaws from January 2011, read in part, The completed reapplication form, requested privileges, peer references and other pertinent information including a query to the National Practitioner Data Bank for each reapplication as required in the initial application process, will be forwarded to the Section Chairman for his recommendation. Where nonreappointment or a change in clinical privileges is recommended, the reason for such recommendations shall be documented. Section 3C indicated appointments to the medical staff would confer on the appointee only such clinical privileges as were specified in the notice of appointment. There was no indication clinical privileges to assist in cardiovascular surgery were granted to Surgeon 5. 2. During a review of the credential file for Surgeon 1, a pre-printed, Request for Clinical Privileges, dated October 27, 2010, was completed by Surgeon 1 during an application for reappointment. The form had many privileges requested designated by written check marks, however the adjacent columns for granting or denying the procedures was left blank. The second page of the form, likewise, had blank columns for granting or denying privileges. The line for the chair of cardiovascular surgery to sign was blank, and the form was signed by the Chairman of the Surgery Department on February 15, 2011, and approved by the MEC and the Board of Directors. During a confidential employee interview on October 19, 2011, at 1:15 p.m., the employee stated the department chairman would not sign and it was not a mistake. According to the Medical Staff Bylaws dated January 2011, the application for privileges would be forwarded to the section chairman for his signature, and where nonreappointment or a change in clinical privileges was recommended, the reason for such recommendations would be documented.

Violation Name: EMERGENCY LABORATORY SERVICES(A-0583)

• Inspection Date: 2011-10-21 (Event ID: NDK111)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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22764 Based on interview and record review, lab tests that were ordered stat (to be done immediately) for one patient needing cardiovascular surgery (Patient 1), were not completed for over two hours from the time ordered, creating the risk of a poor health outcome for the patient due to a delay in surgery. Findings: A facility investigation was conducted on August 23, 2011, due to inappropriate medical record documentation of Surgeon 1 in the record of Patient 1, who was transferred in for an emergent surgery and had to wait for room availability. A dictated medical record note for Patient 1, that was completed by Surgeon 1, regarding an August 23, 2011, surgery for an aortic dissection included the assertion, and included we basically brought the patient in and consent was done and there was a further delay of the aspects of type and cross even though the order was given in the morning, the type and cross was not done until a couple of hours after the order was given. During a review of the medical record of Patient 1, the record indicated stat (immediate) lab test orders were placed at 6:55 a.m., entered in the computer at 7:21 a.m., but the blood was not collected until 8:40 a.m., with no result available until 8:57 a.m., more than two hours after the order was placed. During an interview with the VPQ on October 19, 2011, at 2 p.m., she stated there was no investigation of Surgeon 1's allegation that there was a delay in obtaining the lab results. The facility policy titled, Turn-Around Time for Laboratory Tests, (Revised April 2010), indicated the lab TAT would be less than 60 minutes for tests ordered on a STAT basis.

Violation Name: PATIENT CARE ASSIGNMENTS(A-0397)

• Inspection Date: 2011-04-27 (Event ID: TWDS11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** 18918 Based on interview and record review, the facility failed to ensure three of three Registered Nurses (RN 50, RN 207, and RN 208) demonstrated competence in 1. providing sedation and 2. monitoring patients who received sedation, prior to being assigned to do so. This failed practice resulted in the potential for harm or death in patients undergoing sedation. Findings: 1. During an interview with RN 50 on [DATE], at 9:20 a.m., the RN stated he was getting a patient ready for a cardiac procedure that required conscious sedation. He stated he usually used versed and/or fentanyl (sedative medications) to provide the sedation. He stated he administered the medications, and monitored the patients during and after the procedures. The employee file for RN 50 was reviewed on [DATE]. The file indicated RN 50 answered questions to a written test regarding sedation on [DATE]. There was no evidence in the file RN 50 demonstrated competence in providing the sedation, or monitoring the patient who received sedation. 2. On [DATE], at 9 a.m., a tour of the GI lab was conducted. RN 207 was assigned to Procedure room [ROOM NUMBER] and was assisting with a colonsoscopy (examination of the colon and part of the small bowel with a flexible tube passed through the rectum). Patient 208 underwent this procedure under moderate sedation (conscious sedation- administering sedatives or dissociative agents with or without analgesics to induce a state that allows the patient to tolerate unpleasant procedures while maintaining cardiorespiratory function). Patient 208 received versed and/or fentanyl (sedative medications) during the procedure. The employee file for RN 207 was reviewed on [DATE]. The file indicated RN 207 answered questions to a written test regarding sedation, but there was no evidence in the file RN 207 demonstrated competence in providing the sedation, or monitoring the patient who received sedation. 3. During an interview with RN 208, on [DATE], at 9:30 a.m., RN 208 stated she was recovering patients following their endoscopic procedures. RN 208 stated if the patient met criteria, they were discharged home with a responsible adult. RN 208 stated the nurse in the procedure room was responsible for drawing up the ordered medications. The employee file for RN 208 was reviewed on [DATE]. The file indicated RN 208 answered questions to a written test regarding sedation on [DATE]. There was no evidence in the file that RN 208 demonstrated competence in providing the sedation, or monitoring the patient who received sedation. RN 208's position requirements indicated the nurse was to have successful completion of conscious sedation self study guide and her Sedation analgesia, expired on February 28, 2011. 22764 The facility policy titled, Sedation Analgesia, was reviewed on [DATE]. The policy indicated the following: a. Individuals who provided sedation should be trained and have demonstrated competence in standards and techniques to monitor patients carefully in order to maintain them at the desired level of sedation and to manage complications of sedation; b. Individuals administering sedation would have the appropriate credentials to manage the patient at whatever level of sedation was achieved; c. The nurse responsible for managing the patient should have completed appropriate education and training related to sedation; d. The nurse responsible for managing the patient should be able to demonstrate a working knowledge of resuscitation equipment; e. The nurse responsible for managing the patient should be able to demonstrate the function and use of monitoring equipment; f. The nurse responsible for managing the patient should be able to interpret data obtained; g. For a RN to administer sedation and monitor patients receiving sedation during a procedure, the nurse must demonstrate the acquired knowledge of pharmacology, cardiac dysrhythmia recognition, and complications related to sedation and medications; h. For a RN to administer sedation and monitor patients receiving sedation during a procedure, the nurse must demonstrate skill in airway management and emergency resuscitation; i. For a RN to administer sedation and monitor patients receiving sedation during a procedure, the nurse must possess the knowledge and skills to assess, diagnose, and intervene in the event of complications or undesired outcomes; and, j. For a RN to administer sedation and monitor patients receiving sedation during a procedure, the nurse must successfully complete the established hospital course of instruction in sedation.

Violation Name: SUPERVISION OF CONTRACT STAFF(A-0398)

• Inspection Date: 2011-04-27 (Event ID: TWDS11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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22764 Based on observation, interview, and record review, the facility failed to ensure supervision of two of two non-employee dialysis nurses (Dialysis RN 1 and Dialysis RN 2) who provided services to the hospital patients. This failed practice resulted in the potential for an unlicensed nurse, a non nurse, or a nurse without training to provide dialysis treatments, and the potential for harm or death to patients. Findings: 1. During a tour of the MICU on April 18, 2011, at 2:25 p.m., Dialysis RN 2 was observed pushing a dialysis machine out of a patient room. The RN stated she received her assignments from the agency she worked for the previous night, and when she arrived at the hospital she went to the third floor to get her equipment, then she went straight to the patient's room to do the dialysis treatment. She stated she did not have to check in anywhere in the facility like she did at other places. During an interview with the staffing coordinator on April 19, 2011, the coordinator stated the facility required registry (non employed) nurses were not required to check in before every shift they worked. She stated the staffing office would verify licensure, orientation, evaluation, BLS, and ACLS. She stated they did not require the dialysis nurses to check in when they arrived to do treatments. 2. On April 20, 2011, at 10:15 a.m., during a tour of the fourth floor medical unit, the VP of Quality was asked if a dialysis nurse was available for an interview. The VP made two calls and was unable to obtain the information from staffing personnel. While standing near the nursing station on the fourth floor, a dialysis nurse walked by and was recognized by the VP of Quality. Dialysis RN 1 was interviewed on April 20, 2011, at 10:30 a.m. Dialysis RN 1 was wearing a hospital issued badge that indicated she worked for a contracted agency. Dialysis RN 1 stated she received her assignments for the day, the night before she was scheduled to work at the facility. Dialysis RN 1 stated she had access to a computer on the third floor, and after her arrival at the facility she checked the location of her assigned patients, obtained her equipment, and started her procedures. Dialysis RN 1 stated she did not have to check in with staff prior to starting her day. Dialysis RN 1 stated she was working with a trainee that day. On April 20, 2011, at 10:40 a.m., the VP of Quality stated she did not know what dialysis nurses were there that day. The VP stated she was unaware a trainee was there, and was uncertain if a file was available for the trainee. The VP stated the contracted agency provided a list of nurses who provided dialysis services at the facility. The VP of Quality stated the dialysis nurses did not check in with facility staff when they arrived to do treatments.

Violation Name: MEDICAL RECORD SERVICES(A-0450)

• Inspection Date: 2011-04-27 (Event ID: TWDS11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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20914 Based on record review and interview the hospital failed to ensure that all medical records included a time and date. Two closed surgical records were reviewed (Patients 414 and 415). Each had many examples of untimed progress notes, untimed orders, and verbal orders lacking the time of the physician's authenticating signature. This resulted in an inability for the record to be reviewed accurately for quality purposes. There is no way to determine which events or entries in other sections of the chart were before or after the untimed entries. Findings: Two closed surgical records were reviewed on April 20, 2011, at 11:30 a.m. The record for Patient 414 contained many orders that were not properly authenticated. Examples include Orthopedic post-op orders that were not signed (on either of 2 pages) by the physician, a page of physician orders dated December 1, 2010 that was part pre-printed, part hand-written, that was signed and dated but not timed by the physician and orders for medications on December 1, 2010 that were not dated. The verbal medication order set titled Intraoperative Verbal Orders did not contain the time of the physician's authenticating signature. The record for Patient 515 also had many orders not properly authenticated including a verbal order for insulin dated January 10, 2011, that was not timed when it was authenticated and a verbal order on January 10, 2011, for a bedtime medication that did not have the time of authentication. There was a written order for Home Health dated January, 2011, that was not timed by the physician as well as a written order for several instructions and medications on December 31, 2010, that had no time. Many progress notes in the record for Patient 415 also lacked the time including an entry on December 26, 2010, that seems to say 1 Med #230896, an immediate post operative progress record from December 27, 2010, and two progress notes from December 28, 2010. The progress records for December 29, 2010, had a single vertical mark for a time. It is not clear if this was used to mean 1:00. A progress note from December 30, 2010, was also not timed. The two records were reviewed with the Director of Medical Staff on April 20, 2011, at 12:30 p.m., and the Director of Medical Records, and the VP of Quality and Risk, on April 20, 2011, at 2 p.m All agreed with the findings and deficient practice.

Violation Name: CONTENT OF RECORD: ORDERS DATED & SIGNED(A-0454)

• Inspection Date: 2011-04-27 (Event ID: TWDS11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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20914 Based on record review and interview the hospital failed to ensure that all orders were properly authenticated with a date of the physician's signature. Two closed surgical records were reviewed (Patients 414 and 415). Each had many examples of untimed orders, and verbal orders lacking the time of the physician's authenticating signature. This resulted in an inability for the record to be able to be reviewed accurately for quality purposes. There is no way to determine which events or entries in other sections of the chart were before or after the untimed orders. Findings. Two closed surgical records were reviewed on April 20, 2011, at 11:30 a.m. The record for Patient 414 contained many orders that were not properly authenticated. Examples include Orthopedic post-op orders that were not signed (on either of 2 pages) by the physician, a page of physician orders dated December 1, 2010, that was part pre-printed, part hand-written, that was signed and dated but not timed by the physician and orders for medications on December 1, 2010, that were not dated. The verbal medication order set entitled Intraoperative Verbal Orders did not contain the time of the physician's authenticating signature. The record for Patient 415 also had many orders not properly authenticated including a verbal order for insulin dated January 10, 2011, that was not timed when it was authenticated and a verbal order on January 10, 2011, for a bedtime medication that did not have the time of authentication. There was a written order for Home Health dated Janurry 3, 2011, that was not timed by the physician as well as a written order for several instructions and medications on December 31, 2010, that had no time. The two records were reviewed with the Director of Medical Staff on April 20, 2011, at 12:30 p.m., and the Director of Medical Records, and the VP of Quality and Risk, on April 20, 2011, at 2 p.m All agreed with the findings and deficient practice. The Rules and Regulations of the Medical Staff were reviewed on April 20, 2011, at 3 p.m. Section 4 indicates: All orders for treatment or discharge shall be documented in the medical record. They must be legible, dated, timed and signed.

Violation Name: CONTENT OF RECORD: STANDING ORDERS(A-0457)

• Inspection Date: 2011-04-27 (Event ID: TWDS11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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20914 Based on record review and interview the hospital failed to ensure that all verbal orders were fully authenticated including the time of the physician's signature. Two closed surgical records were reviewed (Patients 414 and 415). Each had many examples of verbal orders lacking the time of the physician's authenticating signature. This resulted in an inability for the record to be able to be reviewed accurately for quality purposes. There is no way to determine which events or entries in other sections of the chart were before or after the untimed authentications of verbal orders. Findings: Two closed surgical records were reviewed on April 20, 2011, at 11:30 a.m. In the record for Patient 414 the verbal medication order set entitled Intraoperative Verbal Orders did not contain the time of the physician's authenticating signature. The record for Patient 415 also had several verbal orders not properly authenticated including a verbal order for insulin dated January 10, 2011, that was not timed when it was authenticated and a verbal order on January 10, 2011, for a bedtime medication that did not have the time of authentication. The two records were reviewed with the Director of Medical Staff on April 20, 2011, at 12:30 p.m., and the Director of Medical Records, and the VP of Quality and Risk, on April 20, 2011, at 2 p.m All agreed with the findings and deficient practice.

Violation Name: Standard-level Tag for Pharmaceutical Service(A-0490)

• Inspection Date: 2011-04-27 (Event ID: TWDS11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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25281 Based on observation, staff interview, and record review, the facility condition of participation for pharmaceutical services was not met as evidenced by the facility's failure to: 1. Ensure patient safety by failing to control and distribute medications to prevent potentially serious medication related errors due to accidental overdose (A500); a.There were two 30-ml injectable vials of 10 units per ml heparin and one 30-ml injectable vial of 100 units per ml that looked identical except the written strength which was highlighted in pink (10 units per ml) and blue (100 units per ml) to distinguish one strength from the other, observed stored next to each other, in the NICU; 2. ensure IV medication compounding areas met the requirement to be compliant according to the USP (United States Pharmacopeia) 797 standards as stated in the facility's policy and procedure (A500); 3. log and account for expired scheduled II-V drugs according to the facility's policy and procedure (A500); 4. ensure medications brought in by the patients were inspected and verified by the pharmacist or the physician before use by the patients in the facility according to the state law (A500); 5. maintain contents in Pediatric Crash Carts that matched the committee approved list of medications to be included in the Cart (A500); 6. administer medication in accordance with the manufacturer's recommendation (A500); 7. store expired scheduled II-V drugs locked in a secure area to prevent access by unauthorized personnel in the Pharmacy (A503); 8. ensure expired and unusable medications were removed from the patient care area and not available for patient use (A505); 9. Ensure enough adenosine (medication used to treat SVT - a dangerously fast heart rate) was available in the adult crash carts to provide a full regimen to a patient suffering from SVT, resulting in the potential for harm or death in these patients (A500); and, 10. Ensure physician orders for medication doses were specific and did not include ranges, resulting in the potential for under or over medicating patients for pain and sedation (A500). The cumulative effect of the systemic problems resulted in the hospital's failure to ensure the provision of pharmaceutical services in a safe environment that met the needs of the patients.

Violation Name: DELIVERY OF DRUGS(A-0500)

• Inspection Date: 2011-04-27 (Event ID: TWDS11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** 22764 7. During a tour of the ED on April 18, 2011, at 10:45 a.m., the contents of the adult crash cart was observed. The medication tray included three vials of adenosine, 6 mg in 2 ml. According to Lexi-Comp's Drug Information Handbook for Nursing, adenosine is indicated for SVT as follows: a. Administer 6 mg rapid IV push (over 1 - 2 seconds); b. If ineffective, repeat in 1 - 2 minutes with 12 mg rapid IV push; c. If ineffective, repeat in 1 - 2 minutes with an additional 12 mg rapid IV push. The facility policy titled, Emergency Carts (Crash Carts), was reviewed on April 20, 2011. The policy included a list of the medications stored in the adult crash cart. The list included three vials of adenosine, 6 mg in 2 ml. To administer 6mg, followed by 12 mg, followed by 12 mg as indicated in the Drug Information Handbook, five vials of adenosine would be needed. The crash cart did not include enough adenosine to provide a complete regimen to a patient suffering from SVT. 8. The record for Patient 302 was reviewed on April 18 and 19, 2011. Patient 302, a [AGE] year old female, was admitted to the facility on [DATE], with diagnoses that included substance abuse and respiratory failure. A physician's order dated April 9, 2011, at 11:25 a.m., indicated the patient was to receive a continuous IV infusion of propofol (used for sedation), with instructions to titrate (increase and decrease) to achieve a MRSS of 2-3. The order did not specify how to titrate the medication, or whether the physician wanted Patient 302 to remain at a MRSS of 2 or of 3. (An MRRS is a scale used to determine the patient's level of sedation to ensure adequate sedation, but not over sedation. The scale ranges from one [anxious and agitated] to six [no response at all]). A physician's order dated April 9, 2011, at 2:45 p.m., indicated the patient was to receive fentanyl (a pain medication) 25-50 mcg IV every hour as needed for pain. The order did not specify whether the physician wanted Patient 302 to receive 25 mcg or 50 mcg. A physician's order dated April 18, 2011, at 3:10 p.m., indicated the patient was to receive a fentanyl continuous IV infusion, with instructions to titrate to a MRSS of 2-3, increasing by increments of 50 mcg/hr. The order did not specify what dose of fentanyl to start with, or whether the physician wanted Patient 302 to remain at a MRSS of 2 or of 3. A physician's order dated April 18, 2011, at 5:32 p.m., indicated the patient was to receive a fentanyl continuous IV infusion of 100 mcg/hr, and increase by increments of 50 mcg/hr, titrating to a MRSS of 2-3. The order did not specify whether the physician wanted Patient 302 to remain at a MRSS of 2 or of 3. The facility ICU sedation pre-printed orders were reviewed on April 19, 2011. Each pre-printed order had a box next to it for the physician to check, and the order would be implemented. The orders included the following: a. Fentanyl infusion 1-2 mcg/kg/hr IV (titrate 1 mcg/kg/hr prn according to pain/MRSS). The order did not specify what dose of fentanyl to start with, what the maximum allowable dose was, or what MRSS value the physician wanted the patient to remain at; b. Fentanyl bolus 1-2 mcg/kg IV (given at start of infusion and every 30 minutes prn for pain). The order did not specify what dose of fentanyl to give, or what the maximum allowable dose was; c. Morphine infusion (given for pain) 1-5 mg/hr IV (titrate 1 mg/hr prn according to the MRSS). The order did not specify what dose of morphine to start with, or what MRSS value the physician wanted the patient to remain at; d. Morphine bolus 2-5 mg IV (given at start of infusion and prn for pain. The order did not specify what dose of morphine to give; e. Versed 1-2 mg bolus IV. Start drip at 2 mg/hr and increase by 1 mg/hr until adequate sedation is achieved. May rebolus with 1-2 mg every 30 minutes for agitation. The order did not specify what bolus dose or rebolus dose(s) to give, or what level of sedation the physician wanted the patient to remain at; f. Propofol infusion, start at 5 mcg/kg/min IV. Increase in 5-10 mcg/kg/min increments every 5-10 minutes until adequate sedation is achieved. The order did not specify what infusion rate to start with, what dose(s) the incremental increases should be, or what level of sedation the physician wanted the patient to remain at; g. Ativan (for sedation) 1-4 mg bolus IV followed by a drip of 1-4 mg/hr. May rebolus prn and increase drip in 1 mg increments every hour until adequate sedation is achieved. The order did not specify what bolus dose or rebolus dose(s) to give, what infusion rate to start with, what the maximum allowable dose was, or what level of sedation the physician wanted the patient to remain at; h. Norcuron (to induce paralysis) bolus: 0.08-0.1 mg/kg IV. The order did not specify what dose of norcuron to give; i. Pavulon (to induce paralysis) initially 0.04 to 0.1 mg/kg IV, then 0.01 mg/kg every 30 to 60 minutes. The order did not specify what initial dose of pavulon to give, or how often to repeat the medication; j. Haldol (for agitation) 2-10 mg IV every hour as needed. The order did not specify what dose of haldol to give; and, k. Haldol (for agitation) infusion 5-10 mg/hr. Increase rate by 1 mg/hr every 20 minutes until patient calm. The order did not specify what initial dose of haldol to give, or what the maximum allowable dose was. 25281 Based on observation, interview, and document review, the facility failed to: 1. Ensure patient safety by failing to control and distribute medications to prevent potentially serious medication related errors due to accidental overdose; 2. Ensure IV medication compounding areas met the requirement to be compliant according to the USP (United States Pharmacopeia) 797 standards as stated in the facility's policy and procedure; 3. Log and account for expired scheduled II-V drugs according to the facility's policy and procedure; 4. Ensure medications brought in by the patients were inspected and verified by the pharmacist or the physician before use by the patients in the facility according to the state law; 5. Maintain contents in Pediatric Crash Carts that matched the committee approved list of medications to be included in the Cart; 6. Administer medication in accordance with the manufacturer's recommendation; 7. Ensure enough adenosine (medication used to treat SVT - a dangerously fast heart rate) was available in the adult crash carts to provide a full regimen to a patient suffering from SVT, resulting in the potential for harm or death in these patients; and, 8. Ensure physician orders for medication doses were specific and did not include ranges, resulting in the potential for under or over medicating patients for pain and sedation. Findings: 1a. Inspection of the facility's NICU was conducted with the DOP on April 21, 2011, at 1:30 p.m. It was noted, in the upper cabinet in the medication storage area, there were two 30-ml injectable vials of 10 units per ml heparin and one 30-ml injectable vial of 100 units per ml that looked identical except the written strength which was highlighted in pink (10 units per ml) and blue (100 units per ml) to distinguish one strength from the other. They were located in separate bins in plastic bags next to each other on the same shelf. During concurrent interview, the DOP stated the heparin vials were prepared by the Pharmacy and acknowledged the potential danger of picking the wrong strength for use on neonatal patients. A nationally recognized organization dedicated to medication error prevention called Institute for Safe Medication Practices (ISMP) had in 2006 recognized the importance of paying special attention to the different strengths of similar looking heparins that contributed to the overdose and death of three infants had this to say about the incident in its publication ISMP Medication Safety Alert Acute Care Edition: Infant Heparin Flush Overdose The news media recently reported that three premature infants died at a Midwestern hospital after receiving an overdose of heparin last weekend. Two, possibly three, other babies also were affected but are not in danger. Apparently, 1 mL heparin vials that contained 10,000 units/mL were placed incorrectly into a unit-based automated dispensing cabinet where 1 mL, 10 units/mL vials were normally kept. The vials looked very similar .Several nurses requested 10 units/mL vials to prepare an umbilical line flush and were directed to that drawer, but did not notice that the vials contained the wrong concentration. No doubt there's a lot more to the story but, for now, we have to say that similar medication errors could probably happen in most hospitals. Automated dispensing cabinet filling errors are quite common. Please take a close look at your own restocking processes. Having a double-check of items before they leave the pharmacy is an important way to prevent mistakes, but even that is not fool-proof. Wherever possible, hospitals should avoid stocking items on nursing units that require further preparation by nurses before administration. As you examine your own practices, pay special attention to cabinets that are used for neonates and pediatric patients, since these are especially high-risk patients. For example, assess the medications and strengths that are stocked in cabinets. The hospital involved is lowering the 10,000 unit strength of heparin. Perhaps this is time for you, too, to consider what might be removed for safety sake. Although not a factor in this case, this is also a good time to examine which medications are being removed from the cabinet without a pharmacist's review. Also, even with the perceived safety of automated dispensing cabinets, hospitals should take steps to minimize look-alike packages and labels. Finally, if you aren't already discussing bar coding at your location, it's time to do so. FDA began requiring bar codes on drug containers for a reason-to help all of us prevent medication errors. Bar coding is valuable for bedside scanning to confirm the accuracy of the patient, drug and dose. But even without bedside scanning, cabinet vendors also provide bar code systems for assuring proper medications are stocked. We don't profess to know the easy answers, but this tragic case brings to light a serious national problem about which all should be concerned. According to ISMP, high-alert medications are drugs that bear a heightened risk of causing significant patient harm when they are used in error. Although mistakes may or may not be more common with these drugs, the consequences of an error are clearly more devastating to patients. During an interview with the DOP on April 21, 2011, at 1:30 p.m., the DOP confirmed heparin was a high risk high alert medication. US Food and Drug Administration (FDA) along with [NAME], manufacturer of the heparin 10 units per ml and 10000 units per ml vials that resulted in the death of 3 infants alerted the health care community about the dangerous error caused by the similarity of the two vials in its FDA MedWatch Alert in February 2007: [NAME] and FDA notified healthcare professionals of the potential for life threatening medication errors involving two Heparin products, Heparin Sodium Injection 10,000 units/mL, and HEP-LOCK U/P 10 units/mL. [NAME] is aware of fatal medication errors that have occurred when two Heparin products with shades of blue labeling were mistaken for each other. Three infant deaths resulted when the higher dosage Heparin Sodium Injection 10,000 units/mL was inadvertently administered instead of the lower dosage of HEP-LOCK U/P 10 units/mL. The currently marketed 1 mL vials of both Heparin products use blue as the prominent background color on their labels. 1b. Inspection of the facility's Transplant Unit was conducted with the DOP on April 20, 2011 at 9 a.m. It was noted in the medication refrigerator there was a plastic bin containing two unit dose tablets of dronabinol (controlled substance used as an appetite stimulant) 2.5 mg and four unit dose tablets of 5 mg dronabinol that were mixed together. It was observed the 2.5 mg and 5 mg dronabinol unit dose tablets were identical in appearance except the written strength. There were no other distinguishable markers. During an interview with the DOP on April 21, 2011, at 1:30 p.m., the DOP stated the different strengths of dronabinol should have been stored separately to prevent picking the wrong strength. 2. The Pharmacy was inspected on April 18, 2011 starting at 10 a.m., with the DOP. It was observed that the IV compounding area was not structurally separated from the rest of the Pharmacy area by a physical wall. There existed a pathway from the front of the Pharmacy leading to the back area of the Pharmacy. On one side of the pathway was the Narcotic drug room and on the other side was the IV compounding area. There was a demarcation line by way of red tape separating the pathway and the IV compounding area. There did not exist an ante-area, designated buffer zone, or area separating the rest of the Pharmacy and the IV compounding area. The IV compounding area had two horizontal laminar flow hoods for mixing TPNs, IV antibiotics, etc. and one vertical flow hood for compounding IV chemotherapeutic agents. It was observed that there was no physical structure that completely separated the area of horizontal flow hoods from the area of vertical flow hoods. Thus there existed interchange of room air between these two areas. It was also observed that the pharmacist was crossing the red tape to get inside the IV compounding area to check and approve for dispensing the drugs compounded by the technicians. It was observed the pharmacist did not use gloves or gowns before crossing the red tape. It was also observed that the pharmacy technician with gloves and gowns from inside the IV compounding area crossed the red tape walked across the pathway and placed compounded IV medications on the cart and walked back in the IV compounding area and was observed to not wash his hands. It was also observed the pathway directly next to the IV compounding area was used frequently by the Pharmacy staff to get from the front of the Pharmacy to the back. During an interview with the DOP on April 18, 2011, at 10:15 a.m., the DOP acknowledged that the IV compounding area was not yet compliant with the USP 797 standards and was in the process of meeting the standards. The DOP also stated the authorized staff needed to wear gloves and gowns before crossing the red tape to enter the IV compounding area. The facility's policy and procedure titled, Compounded Sterile Preparations (CSPs) - General Information, that was reviewed stated, II. Policy . Sterile product compounding shall be performed in compliance with the current USP-NF Chapter 797 regulations, State Board of Pharmacy Laws and Regulations and recommendations from the Joint Commission on Accreditation of Health Care Organizations. The facility's policy and procedure titled, IV Solution, that was reviewed stated, III. Procedure . 2. A clean work area with adequate lighting, isolated from heavy traffic will be provided . 5. Wash hands before beginning admixture, and after any interruption, which could contaminate hands. According to American Society of Health-System Pharmacists (ASHP), a nationally recognized organization, publication titled, ASHP Guidelines on Handling Hazardous Drugs, Environment. Hazardous drugs should be compounded in a controlled area where access is limited to authorized personnel trained in handling requirements. Due to the hazardous nature of these preparations, a contained environment where air pressure is negative to the surrounding areas or that is protected by an airlock or anteroom is preferred. Positive pressure environments for hazardous drug compounding should be avoided or augmented with an appropriately designed antechamber because of the potential spread of airborne contamination from contaminated packaging, poor handling technique, and spills. US Pharmacopeia on its website addressed the requirement to have a negative pressure room for preparation of hazardous drugs below in questions and answers format: 73. Can [NAME] that meets the negative pressure requirement be used if it is placed in a regular room or does the negative pressure [NAME] need to be placed in a separate negative pressure room? The [NAME] shall be placed in a separate negative pressure room. The ISO Class 5 (see Pharmacists' Pharmacopeia, Table 1, page 797) BSC or [NAME] shall be placed in an ISO Class 7 (see Table 1 above) area that is physically separated (i.e., a different area from other preparation areas) and optimally has not less than 0.01- inch water column negative pressure to adjacent positive pressure ISO Class 7 (see Table 1 above) or better ante-areas, thus providing inward airflow to contain any airborne drug. However, in facilities that prepare a low volume of hazardous drugs, the use of two tiers of containment (example: closed-system vial-transfer device within a BSC or [NAME] that is located in a non-negative pressure room) is acceptable. 76. Should the room be negative pressure if you have a room with a horizontal flow hood and a vertical flow hood for hazardous drugs? As stated in chapter <797>, hazardous drugs shall be prepared in a negative pressure room. All hoods and procedures used in the room should be designed for proper operation in the negative pressure environment unless the situation allows for the low volume exception in the chapter. A second-tier of containment (e.g., CSTD) would be required when a BSC is located in a positive-pressure ISO Class 7 buffer area. 79. Can you explain what a closed-system vial transfer device (CSTD) is? A Closed System Vial Transfer Device is a generic term used to describe a device that does not allow any substance to escape outside the vial or bag during the transfer process. This will include vapors, liquids, powders, etc. The system should be totally closed. An air vent is not considered a closed system even if the vent includes a 0.22 micron filter. 3. During inspection of the Pharmacy on April 18, 2011 starting at 10 a.m., it was noted there was a cabinet located within the controlled substance (CS) Drug Room. There was another cabinet in black located just near the Pharmacy main entrance door. The room had the door removed. These cabinets contained expired controlled medications and they were observed to be unlocked. The facility's expired controlled substance log book was examined and noted that the log was missing entries for the expired controlled medications received or checked in for the past 4 months which was the time the expired controlled medications were picked up by the contracted company for disposal. During concurrent interview with Pharmacist 500 on April 18, 2011 starting at 10 a.m., he stated the technicians would check in expired controlled substances and place them in the cabinet and the expired controlled drugs were logged in the book at the time of pick up by the company for disposal. The facility's policy and procedure titled, Expired Drugs, was reviewed and it stated, III. Procedure A. The Pharmacy Staff shall check: 1. To see that outdated drugs are placed in appropriate bin for credit. 2. Outdated Schedule II Controlled Substances. These shall be separated and logged for returns processing. 3. Outdated Schedule III Controlled Substances. These shall be separated and logged for returns processing. During concurrent interview with Pharmacist 500 on April 18, 2011, at 10:15 a.m., he acknowledged the outdated controlled substances in the box were not logged. 4. During inspection of the Medication Room located on sixth floor Medical/Surgical Unit on April 18, 2011 at 2 p.m., it was noted there were following prescription medications filled at outpatient pharmacies for two patients: Synthroid 0.05 mg #30 filled at Walgreens Pharmacy for Patient 500; and, Thiothixene 10 mg #21 in a blister pack filled at RxExpress Pharmacy for Patient 501. It was also noted there was no indication these medications were verified by either a licensed pharmacist or a physician. During concurrent interview, RN 500 stated both patients were discharged and no longer in the hospital. During concurrent interview, the DOP stated the medications were not verified and acknowledged they should not have been used until sent to the Pharmacy for verification. The DOP did not provide evidence the Pharmacy was aware of the medications filled from outside sources being used in the facility. The facility's policy and procedure titled, Drugs Brought at Admission was reviewed and it stated, II. Policy All drugs brought by the patient on admission to the hospital will be sent home with the patient's family, unless a physician writes an order for the drugs to be administered while in the hospital. If no family is available to take medications home, the medications will be delivered in person to Pharmacy for safe keeping, until the patient is discharged . III. Procedure E. If the physician writes an order for the patient to have their own medication from home, the nursing staff will hand-deliver medication to Pharmacy for identification prior to administration at Riverside Community Hospital. 5. During inspection of the facility's Pediatric Unit on April 18, 2011 at 3:30 p.m., it was observed in the Pediatric Crash Cart there were one 30-ml vial bottle of Cetacaine (local anesthetic) and one 30-ml tube of lidocaine (local anesthetic) 2 percent jelly inside the top drawer with adjacent sealed drug tray. The approved list of medications in the Pediatric Crash Cart was reviewed and it did not include these two medications. During concurrent interview, the DOP acknowledged that these extra medications should not have been included in the Pediatric Crash Cart. 6. During medication pass observation conducted on April 19, 2011 starting at 8:30 a.m., it was observed RN 500 administered via IV route 40 mg Protonix (drug for acid reflux) for Patient 502. The infusion of the medication lasted less than forty seconds. During concurrent interview, the DOP acknowledged the infusion should have lasted at least 2 minutes. According to the Package Insert that accompanied Protonix IV, Two Minute Infusion Protonix I.V. for Injection should be reconstituted with 10 ml of 0.9 percent Sodium Chloride Injection, USP, per vial to a final concentration of approximately 4 mg/ml. The reconstituted solution may be stored up to 24 hours at room temperature prior to intravenous infusion and does not need to be protected from light. The total volume from both vials should be administered intravenously over a period of at least 2 minutes.

Violation Name: CONTROLLED DRUGS KEPT LOCKED(A-0503)

• Inspection Date: 2011-04-27 (Event ID: TWDS11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** 25281 Based on observation, interview, and document review, the facility failed to store expired scheduled II-V drugs locked in a secure area to prevent access by unauthorized personnel in the Pharmacy. Findings: During inspection of the Pharmacy on [DATE] starting at 10 a.m., it was noted there was a cabinet located within the controlled substance (CS) Drug Room. There was a second cabinet (black in color) located just near the Pharmacy main entrance door. The door to the room had been removed. Inside the controlled substance medication room was a medication refrigerator containing controlled substance that was also unlocked. During an interview with Pharmacist 500 on [DATE], at 10 a.m., the pharmacist stated the expired controlled substances were checked in and collected in box inside the cabinet located in the CS Drug Room and that the cabinet was supposed to be locked, with the key located within the Pyxis CII Safe MedStation (automated dispensing cabinet for controlled substances). Inspection of the Pyxis CII Safe MedStation revealed that the key to the cabinet was not located in the CII Safe Medstation. Pharmacist 500 found the key in the black cabinet located outside the CS Drug room and it was observed to be open and also contained expired controlled substances. Pharmacist 500 explained that both cabinets were in the CS Drug Room before Pyxis CII Safe was placed inside it and the black cabinet was placed outside because of space limitations. Pharmacist 500 added that both cabinets and the medication refrigerator should have been locked at all times. The facility's policy and procedure titled, Controlled Substances - Scheduled, was reviewed and it stated: III. Procedure . E. Pharmacist shall . 8. Please keep narcotic vault door closed at all times . The facility failed to store expired scheduled II-V drugs locked in a secure area to prevent access by unauthorized personnel in the Pharmacy.

Violation Name: UNUSABLE DRUGS NOT USED(A-0505)

• Inspection Date: 2011-04-27 (Event ID: TWDS11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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18918 3. During a review of the medication cart used by RN 200, on April 18, 2011, at 11 a.m., two opened vials of insulin were observed. Each vial of insulin had a sticker applied to document the expiration date. A ten milliliter (ml) vial of Novolin 70/30 insulin had a written expiration date of April 15, 2011, three days ago. The second vial, a ten ml vial of Humalog, had a written expiration date of April 14, 2011, four days ago. In an interview with the unit RN 200 and the unit director, on April 18, 2011, at 11 a.m., the director stated the written date should be 28 days from the day the vial was opened. The director stated in this case the date may have been the date the insulin vials were opened, but there was no way of knowing. During a review of the medication cart used by RN 202, on April 18, 2011, at 11:10 a.m., opened vials of insulin were noted to have plastic zip type tags attached with hand written expiration dates. RN 202 stated the vials come up from the pharmacy with the tags and the vials expire on the date indicated on the tag. The facility's policy and procedure for Medication Administration, with a last revised date of February 2011, was reviewed on April 20, 2011. The policy and procedure indicated in the section titled Procedures, indicated Insulin must be dated with a 28 day expiration date when first opened and discarded after 28 days. 25281 Based on observation and interview, the facility failed for one of two medication carts on unit D3 and in the main pharmacy, to ensure medications available for patient use had not expired, resulting in the potential for administration of outdated, ineffective medications. Findings: 1. During inspection of the Pharmacy on April 18, 2011 starting at 10 a.m., it was noted the following unusable medications were stored together with usable medications in the Pharmacy medication refrigerator: One vial of Tubersol (Tuberculin Purified Protein Derivative injection used to test for tuberculosis) with an open date of December 22, 2010; Two single use vials of Cubicin 500 mg for injection that were reconstituted; and one Novolin insulin R multi-use vial without open date. During concurrent interview with Pharmacist 500 and the DOP on April 19, 2011 at 3:30 p.m., the DOP acknowledged these vials should have been removed from the medication refrigerator and the insulin vial should have been dated. 2. During inspection of the medication storage rooms of the facility's Pediatrics Unit on April 19, 2011 at 3:30 p.m., it was noted there was an open packet containing three 2-ml budesonide (steroid inhalation solution for asthma or airway disease) 0.5 mg/2 ml inhalation unit-of-use solutions. The drug is packaged by the manufacturer in foil envelopes. When opened per package insert it should be used within two weeks. The open foil envelope did not have the date opened. During concurrent interview with the DOP on April 19, 2011 at 3:30 p.m., he acknowledged the open date was not present and the drug should have been removed. The review of the facility's policy and procedure titled, Expired Drugs, indicated the following: II. Policy .Outdated or otherwise unusable drugs shall be removed from distribution to prevent administration to patients.

Violation Name: FOOD AND DIETETIC SERVICES(A-0618)

• Inspection Date: 2011-04-27 (Event ID: TWDS11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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27157 Based on observations, staff interview and document review, the hospital condition of participation for food and dietetic services was not met as evidenced by: 1. The hospital failed to employ a director of food and dietetic services that was full-time in that capacity. The Food Service Director failed to ensure organized dietary services (Cross refer A-620, A-630); 2. The Food Service Director failed to ensure the daily management of dietary services to provide patients with safe high quality food due to a lack of monitoring of cool down of potentially hazardous foods (Cross refer A-620, A-749, A-622, A-267); 3. The hospital failed to ensure that equipment in the kitchen was maintained in good condition to ensure a safe and sanitary environment. (Cross refer A-620, A-724, A-749), and 4. The hospital failed to develop a system that integrated the food and dietetic service into the hospital-wide QAPI (quality assurance program improvement) and Infection Control programs (Cross refer A-267, A-749, A-620, A-622, A-724, A-0629, A-0630). The cumulative effects of these systemic problems resulted in the hospital's inability to ensure safe food handling to prevent the potential of food borne illness and to ensure quality and coordinated nutrition care was provided to patients. The cumulative effects of systemic problems resulted in the hospital's inability to ensure the provision of dietetic services for the health and safety needs of patients in compliance with the Condition of Participation for Food and Dietetic Services.

Violation Name: DIRECTOR OF DIETARY SERVICES(A-0620)

• Inspection Date: 2011-04-27 (Event ID: TWDS11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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27157 Based on food service observation, interview, and record review, the hospital failed to employ a director of food and dietetic services that was full-time in that capacity. The hospital failed to ensure safe food handling practices as evidenced by: 1. potentially hazardous foods were not consistently cooled down, 2. a gas and sewage smell in the kitchen was not completely addressed by hospital staff, 3. the ice-machines in the kitchen were not sanitized, and 4. staff were unclear on how to utilize the planned Disaster menu which could impact the nutritional needs of patients in the event of a disaster. Findings: On April 26, 2011, at 11:45 a.m., the GMMS stated he was the general manager of multiple services. The GMMS stated he spent 20 -30% of his time to provide consultation to the environmental services (EVS) department. The GMMS stated he had the authority and responsibility for the operation of the food and dietetic services department. On April 26, 2011, at 1:45 p.m., the COO acknowledged the GMMS was the person who had the authority and responsibility for the food and nutrition department, and he stated, He's the food service director. On April 27, 2011, at 10:15 a.m., in the hospital's dietary policies and procedures manual was an organization chart entitled Nutritional and Environmental Services Organization Chart. The GMMS had oversight over the food and nutrition department, and also had oversight over the EVS Director. The organizational structure and functions diminished the GMMS to less than full-time over the food and nutrition department. 1. On April 25, 2011, at 11:10 a.m., in the walk-in refrigerator was a large pan that was approximately 6 inches deep that contained roast beef, with a sticker label on the pan that indicated 4/23/11 and use by 4/26/11. On April 25, 2011, at 11:30 a.m., the Executive Chef stated the large pan of roast beef in the refrigerator was approximately 35 pounds. The Executive Chef stated the HACCP COOLING AND REHEATING CHART TIME/TEMPERATURE LOG FOR POTENTIALLY HAZARDOUS FOODS lacked documentation that the roast beef was cooled down safely. During the same interview, the Executive Chef stated he was responsible for ensuring that foods were cooled down safely and that they were documented on the cool down log. The Executive Chef held the HACCP COOLING log and stated, If roast beef has not reached 70 degrees F after 2 hours then it needs further cooling. According to the instructions that were located on the HACCP COOLING AND REHEATING CHART TIME/TEMPERATURE LOG FOR POTENTIALLY HAZARDOUS FOODS, Critical Control Points: Food is cooled quickly and safely from 140 degrees F to 70 degrees F within 2 hours and then to 40 degrees F or below within an additional 4 hours (total cooling time 6 hours). A review of the HACCP COOLING AND REHEATING CHART TIME/TEMPERATURE LOG FOR POTENTIALLY HAZARDOUS FOODS, from March 2, 2011 - April 6, 2011, indicated that roast beef was greater than 70 degrees F after the initial 2 hour cool down time for 14 of 17 (82%) logged entries. Directions on the log indicated, SEE REVERSE SIDE OF THIS FORM FOR: --Corrective action steps if time/temperature requirement for cooling and reheating have not been met. The reverse side of the log that had the above entries was blank. There was no Xeroxed copy on the reverse side, it was one-sided only. According to standards of practice in the food service industry if the initial cooling to 70?F took 3 hours, for example, the food safety hazards may not be adequately controlled (FDA Food Code 2009) A review of the April 2011 HACCP ROAST MEAT CHART indicated that roast beef in quantities between 40 - 50 lbs were cooked a total of seven times from 4/13/11 - 4/23/11. The Executive Chef stated that the roast beefs on the April 2011 HACCP ROAST MEAT CHART should have been cooled down, and documented on the HACCP COOLING AND REHEATING CHART TIME/TEMPERATURE LOG FOR POTENTIALLY HAZARDOUS FOODS. The Executive Chef reviewed the cooling logs and stated that four cooks were not documenting cool-down on the logs. The Executive Chef acknowledged that there was no documentation on the cool down logs to indicate that the roast beefs that were cooked from April 13, 2011- April 23, 2011 were cooled down safely. A potentially hazardous food that is allowed to remain in the temperature danger zone enough for the bacteria to produce toxins will become unsafe to eat. Most toxins are not destroyed by high temperatures which could cause a food borne illness. Excessive time for cooling of potentially hazardous foods has been consistently identified as one of the leading contributing factors to foodborne illness. (FDA Food Code 2009) 2. On April 25, 2011, at 2:45 p.m., there was an odor in the kitchen that seemed to smell like gas and/or sewage as verified by the GMMS, and the QI Director. The odor would come strong and then fade over the following 45 minutes. The GMMS stated he thought it was due to a pilot light. On April 25, 2011, at 3:10 p.m., the Executive Chef stated the gas valve needed a repair on the previous Saturday which was done by an outside company that was arranged by the hospital's engineering staff. The Executive Chef acknowledged he had smelled gas in the kitchen even after the repair. The Executive Chef and the GMMS both stated the gas odor had not been reported to hospital staff since the Saturday repair. The invoice from the outside service that did the repair on the gas valve was requested. The invoice was not provided to the surveyor prior to exit on April 27, 2011. On April 25, 2011, at 4:10 p.m., the Director of Engineering indicated he was not aware there was a problem in the kitchen of a gas odor, and stated he was not aware there was a repair on a gas valve in the kitchen on the previous Saturday. On April 25, 2011, at 4:17 p.m., in the kitchen, was a large metal panel on the floor, and above that location was a food preparation table. An odor was coming from the area that smelled like sewage as acknowledged by the QI Director, and Engineering Staff 1. Engineering Staff 1 stated that underneath the panel was sewage pipes. To the left of the panel on the floor was a floor drain in which three small black insects flew out of. On April 25, 2011, at 4:21 p.m., the Director of Engineering was in the kitchen and stated, We do not routinely flush plumbing. We wait until it plugs up. According to review of work orders placed by the dietary department to the engineering department, there were seven work orders placed in 2010 that referred to clogged and smelly drains in the kitchen. One of the work orders, dated May 27, 2010, indicated 1. There is a possible gas leak on an oven in the kitchen. 2. There is a chemical smell of some kind coming from a floor drain in the kitchen .Smell coming from tunnel hatch. Although the work orders had a completion date listed, the hospital was unable to demonstrate that there was a preventative maintenance system in place. On April 25, 2011, at 4:25 p.m., Engineering Staff 1 used a Flammable Gas Detector and stated the device did indicate that there was a gas leak in the kitchen. Engineering Staff 1 identified the piece of equipment in which he determined the gas leak was coming from. He further stated the device was not signaling that there was a gas leak by another oven in which the repair was completed on the previous Saturday. The hospital then contacted an outside service to assess the odors in the kitchen. On April 25, 2011, at 4:53 p.m., Dietary Staff 2 was asked how long she had smelled the unusual odor in the kitchen and she stated, It's been about a month. On April 26, 2011 the hospital provided a copy of the invoice for the outside company that was chosen to assess the odor. The invoice was from a plumbing company and indicated, 4/25/11; Upon arrival smell of gas in kitchen unable to use gas sniffer due to draft from access panel uses gas bubbles to find leak on gas line at ball valve on 1 ? gave .removed ball valve and put cap on line. Improper maintenance of plumbing may result in potential health hazards or creation of other unsanitary conditions that may attract insects and other vermin. 3. On April 25, 2011 at 2:56 p.m., in the presence of the Manager of Engineering, Engineering Staff 1 stated he used a cleaner on both ice-machines in the kitchen to de-scale on a quarterly basis. Engineering Staff 1 was asked to bring all products used on the ice-machine, in which he brought the de-scale cleaner. The Manager of Engineering stated he was a manager and that he trained the engineering staff on how to clean the ice-machines in the kitchen. The Manager of Engineering stated he did not have any additional steps to add to Engineering Staff 1's comments about the maintenance of the ice-machine. He also verified no other products were used on the ice-machine. Engineering Staff 1 was asked to remove the panel from the ice-making apparatus to expose the internal components. There were furry brown substances on the inside. The Manager of Engineering stated, It is due to be cleaned. On the inside of one of the ice-machines were posted manufacturer's guidelines that indicated the ice-machine should have been sanitized using a hypochlorite solution (household bleach). Engineering Staff 1 and the Manager of Engineering acknowledged the ice-machines in the kitchen were not being sanitized. Engineering staff provided the manufacturer's guidelines for each ice-machine in the kitchen, that were made by two different manufacturers. Both manufacturers' guidelines indicated the ice-machines had a sanitizing step, and a hypochlorite solution would be appropriate for each machine. Two of two ice-machines located in the kitchen were not sanitized in accordance with manufacturer's guidelines. 4. On April 25, 2011, at 1:20 p.m., the GMMS stated in the event of a disaster the hospital's Disaster Menu was planned to feed 1500 people per day for 5 days. The GMMS provided a policy and procedure (P&P) entitled CODE TRIAGE - EMERGENCY MASS FEEDING PLAN (NUMBER: FNS342, last approved April 22, 2009). The GMMS, in the presence of the Clinical Nutrition Manager and QI Director, was asked to provide the disaster menu that hospital staff would use to meet the nutritional needs of patients in the event of a disaster. The GMMS provided P&P 342, pages 4-8, that indicated Table 4. Sample Disaster Menu. The GMMS verified the Sample Disaster Menu was the disaster menu that was to be implemented by hospital staff during the event of a disaster. The Sample Disaster Menu was not detailed on how the nutritional needs of patients on a therapeutic diet or texture modification would be met in the event of a disaster. The menu for lunch on Day 1 indicated, 2 oz. protein; cheese, sliced meat, tuna or other protein foods not requiring cooking, bread product (2 oz) - bread, bagel, English muffin, dinner roll, crackers, vegetable (1/2 cup) - green salad or other raw vegetables as appropriate to pt diet. Use refrigerated dressing, individual packets or oil and vinegar, 8 oz. milk (EXCEPT RENAL GIVE JUICE) ENLIVE - CLEAR LIQUIDS ONLY, Fruit (1/2 cup) ENSURE PUDDING-PUREE/FULL LIQUIDS. The disaster menu for Day 1 for dinner for a full liquid diet order indicated Fruit (1/2 cup) APPLESAUCE -PUREE/FULL LIQUIDS. The CNM acknowledged there was not a detailed written plan on what hospital staff should serve to those patients on a full liquid diet order, other than a pudding for lunch, and apple sauce for dinner. The disaster menu also indicated to give juice to those patients on a renal diet instead of milk. There was no written direction for hospital staff on what juice to include, or omit, for those on a renal diet in which there was potential for dialysis to be interrupted during the event of a disaster. The GMMS and the CNM stated they were aware the disaster menu was not clear. On April 25, 2011, at 3:30 p.m., the CNM provided another set of Disaster Menus. The CNM acknowledged they were isolated to her computer and hospital staff had not been trained on how to implement the newly developed menu, nor had the disaster inventory supply been evaluated and compared to the newly developed disaster menu. In addition, the CNM was not able to clearly state the kitchen equipment that would remain in working condition via generator, or for duration of usage, in order to support the menu as developed, which included use of frozen entrees and defrosted meat to cook on day 3 and day 4 of a disaster. On April 26, 2011, at 1:20 p.m., the GMMS stated the freezers in the kitchen would be on emergency generators in the event of a disaster. According to the hospital's DISASTER PLAN; NUTRITIONAL SERVICES, page 21 ELECTRICAL FAILURE WITH EMERGENCY GENERATOR BACK UP, A. Kitchen - areas with emergency generator back up 1. Ceiling lighting, 2. All walk in refrigerators, 3. All upright refrigerators, 4. Ice Machine, 5. Food warmer near cafeteria, 6. Dish Machine, no conveyor, and 7. Receptacles located on either end of the cooks prep tables. According to the hospital's DISASTER PLAN; NUTRITIONAL SERVICES, RESPONSIBILITY A. Planning, preparing and serving patient and staff meal appropriate to their needs while ensuring food safety and sanitation. B. Ensure that all patients receive meals appropriate to their diet orders. To provide nutritional assessment and support to patients at nutrition risk.

Violation Name: COMPETENT DIETARY STAFF(A-0622)

• Inspection Date: 2011-04-27 (Event ID: TWDS11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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27157 Based on observation, interview and record review, the GMMS failed to ensure the Executive Chef was competent in safe cool-down of potentially hazardous foods before delegating the Executive Chef to be in charge of cooks. Findings: On April 25, 2011, at 11:30 a.m., the Executive Chef stated a large pan of roast beef, observed in the refrigerator, was approximately 35 pounds and was cooked previously at the facility to be served on another day. The Executive Chef stated the facility HACCP COOLING AND REHEATING CHART TIME/TEMPERATURE LOG FOR POTENTIALLY HAZARDOUS FOODS lacked documentation that the roast beef was cooled down safely. During the same interview, the Executive Chef stated he was responsible for ensuring foods were cooled down safely and that they were documented on the cool down log. He further added he was responsible to train the cooks on proper cool down procedures. The Executive Chef held the HACCP COOLING log and stated, If roast beef has not reached 70 degrees F after 2 hours then it needs further cooling. According to the instructions that were located on the HACCP COOLING AND REHEATING CHART TIME/TEMPERATURE LOG FOR POTENTIALLY HAZARDOUS FOODS, Critical Control Points: Food is cooled quickly and safely from 140 degrees F to 70 degrees F within 2 hours and then to 40 degrees F or below within an additional 4 hours (total cooling time 6 hours). According to standards of practice in the food service industry if the initial cooling to 70?F took 3 hours, for example, the food safety hazards may not be adequately controlled (FDA Food Code 2009). On April 25, 2011, at 2:46 p.m., the Executive Chef reviewed the cooling logs and stated the four cooks were not documenting cool-down on the logs. The Executive Chef acknowledged there was no documentation on the cool down logs to indicate the roast beefs that were cooked from April 13, 2011 - April 23, 2011 were cooled down safely. According to the Executive Chef's 2010 performance evaluation, the GMMS documented that the Executive Chef was below expectations under the category of Ensuring Safe and Quality Operations, and indicated, Weekly kitchen inspections turn up violations of Department of Health Services (DHS) laws such as undated product, outdated product and temperature charts are not filled out. Under the category of Value Behaviors on the Executive Chef's performance evaluation the GMMS indicated, Below expectations .should take more personnel accountability within his kitchen an actively take corrective action when needed. According to a Management Skill Competencies list completed in 2010 for the Executive Chef, a score of 1 was given for Demonstrates/articulates the handling and storage standards for all perishable food products, the danger zone, 3 primary causes of FBI [foodborne illness] and 3 primary preventins. A score of 1 was also rated for the Executive Chef under the category of Articulates the process and systems that assure food quality and critical control points. The possible scoring available on the Management Skill Competencies check list was 0, 1, or 2 with 2 being the highest. The GMMS did not have a system in place to increase oversight over the high risk, and potentially problem prone pre-day cooking method of potentially hazardous foods despite being aware that the Excecutive Chef was displaying performance that was below expectations.

Violation Name: THERAPEUTIC DIETS(A-0629)

• Inspection Date: 2011-04-27 (Event ID: TWDS11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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27157 Based on interview and record review, the hospital failed to ensure that a tube-feeding, and a therapeutic diet order were ordered by a physician prior to providing to patients. (Patient 7 and 5) Findings: On April 27, 2011, at 11:45 a.m., Patient 7's paper medical record and electronic medical record was reviewed. On April 7, 2011 there was a physician's order that indicated, T.feed [tube feed] per Dietitian eval [evaluation]. LN 8 reviewed Patient 7's clinical record and verified that a nurse provided tube feeding of Jevity 1.2 at 20 cc hr on April 8, 2011, while gradually increasing the rate to Jevity 1.2 at 75 cc/hr on April 9, 2011. LN 8 stated that a RD left a yellow note to the physician communicating a recommendation to the physician to start a tube-feeding of Jevity 1.2 at 20 cc/hr to an eventual goal rate of 75 cc/hr. LN 8 stated that the nurse infused the tube feeding as recommended by the RD, without obtaining a specific physician's order. LN 8 stated, Some of my nurses treat it [the RD's yellow communication note to the physician] as an order and they need some in-servicing on that. On April 27, 2011, at 1:09 p.m., Patient 5's record was reviewed by the Clinical Nutrition Manager and LN 10. The CNM and LN 10 verified there was not a physical MD order in the clinical medical record despite a nurse entering a diet order for 1800 calorie ADA diet on April 11, 2011 and diet order of 1800 calorie ADA mechanical soft chopped on April 12, 2011 into the electronic medical record. The QI Director and LN 10 verified the physicians do not write their orders directly into the electronic medical record, and there should have been a manually written physician's diet order in the clinical record to correspond with the diet orders entered by the nurse into the electronic medical record system. The QI Director stated the patient had an NPO diet order at one point, and then a nurse probably resumed a diet order after speaking to an MD, but no physician's diet order was obtained. According to the hospital's policy and procedure entitled NUTRITION CARE DOCUMENTATION IN THE MEDICAL RECORD, DIET ORDER CONFIRMATION; The physician is responsible for providing a written diet order for all patients (includes NPO order).

Violation Name: DIETS(A-0630)

• Inspection Date: 2011-04-27 (Event ID: TWDS11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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27157 Based on interview and record review, the hospital failed to serve three diabetic and one renal therapeutic diet order as written by the physician for four patients (Patient 3, 4, 5 and 6). Findings: On April 25, 2011 at 5 p.m., Dietary Staff 7 stated the dietary department provided Patient 3 with 1,521 calories on April 25, 2011 based on the dietary office electronic nutrient data system. Dietary Staff 7 stated the 1,521 calories accounted for the breakfast, lunch and dinner, and there were no snacks provided, nor was there a PM snack planned, for April 25, 2011. Dietary Staff 7 stated the physician's diet order for Patient 3 was 2,000 calories ADA diet. The dietary department provided 479 calories less than the physician's prescribed therapeutic diet order on April 25, 2011. The CNM was present during the joint record review of the electronic nutrient data system. During an interview on April 25, 2011, at 5 p.m., Dietary Staff 7 stated the dietary department provided Patient 4 with 1,392 calories based on the dietary office electronic nutrient data system. Dietary Staff 7 stated the 1,392 calories accounted for the breakfast, lunch and dinner, and there were no snacks provided, nor was there a PM snack planned, for April 25, 2011. Dietary Staff 7 stated the physician's diet order for Patient 4 was 1,800 calories ADA diet. The dietary department provided 408 calories less than the physician's prescribed therapeutic diet order. Dietary Staff 7 stated the dietary department provided Patient 5 with 1,200 calories on April 25, 2011 based on the dietary office electronic nutrient data system. Dietary Staff 7 stated the 1,200 calories accounted for the breakfast, lunch and dinner, and there were no snacks provided, nor was there a PM snack planned, for April 25, 2011. Dietary Staff 7 stated the physician's diet order for Patient 5 was 1800 calories ADA diet, renal. Record review for % PO intake from April 21, 2011 - April 25, 2011 indicated Patient 5 was eating 90 -100% of her meals the majority of the time. The dietary department provided 600 calories less than the physician's prescribed therapeutic diet order. Dietary Staff 7 stated the dietary department provided Patient 6 with 51 grams of protein on April 25, 2011 based on the dietary office electronic nutrient data system. Dietary Staff 7 stated the 51 grams of protein accounted for the breakfast, lunch and dinner, and there were no snacks provided, nor was there a PM snack planned, for April 25, 2011. Dietary Staff 7 stated the physician's diet order for Patient 6 was 60 grams of protein, 2 grams of sodium, 2 grams of potassium. On April 27, 2011 at 2 p.m., the CNM stated the dietary staff should have been ensuring that the dietary office provided the specified amount of calories and/or protein in accordance with the physician's therapeutic diet order. The CNM stated she was aware that there was one operator [ie dietary staff] on multiple occasions who failed to ensure that the dietary Diet Menu Guidelines policy was followed. The CNM provided the dietary Diet Menu Guidelines which provided instruction to dietary staff as follows, .Diabetic; Patients need to meet within .5 of their carb [carbohydrate] allowance at each meal. Calorie level can be met with adding protein and fat items such as additional meat portions, salad dressings, margarine, sour cream, peanut butter, etc. Patients must be within 50 calories of their caloric level by the end of the day . Renal; .If patients are on a specific protein allowance, that protein allowance must be met by the end of the day, NO exceptions.

Violation Name: THERAPEUTIC DIET MANUAL(A-0631)

• Inspection Date: 2011-04-27 (Event ID: TWDS11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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27157 Based on interview and record review, the hospital failed to customize their on-line diet manual to be hospital specific. Findings: On April 27, 2011 at 2:15 p.m., the CNM stated the hospital's on-line ADA Nutrition Care Manual had not been customized to reflect how therapeutic diet orders were defined and approved by the medical executive team and governing body. The on-line ADA Nutrition Care Manual had not been customized to reflect the therapeutic diets routinely ordered at the hospital and was too broad to be used as guidance for preparing patient diets at [hospital name]. The CNM acknowledged there were carbohydrate patterns that the diet office used in order to implement various calorie level of diabetic diets that were routinely ordered at the hospital. A doctor, nursing or food service personnel would not be able to use the on-line ADA diet manual to obtain information on how a diabetic diet would be implemented for a patient on a diabetic diet at the hospital. The hospital's on-line ADA Nutrition Care Manual, that was the hospital's reviewed and approved diet manual, according to the CNM, was not customized to include the actual practice that the hospital used to carry out a variety of diet orders. The CNM stated, It's a work in progress. The hospital's policy and procedure entitled DIET MANUAL (last approved by the Medical Executive Committee on 12/08) indicated, Nutritional Services provides accurate diet modifications, as prescribed by the physician, and in accordance with the approved Manual of Clinical Dietetics. The manual will serve as a guide to ordering diets, and the menus served will be consistent with the requirements of the manual.

Violation Name: INFECTION PREVENTION CONTROL ABX STEWARDSHIP(A-0747)

• Inspection Date: 2011-04-27 (Event ID: TWDS11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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21898 Based on observation, interview and record review, the facility condition of participation for infection control was not met as evidenced by the facility's failure to ensure: 1. the hospital's infection control officer had a system to identify deficient infection control practices relating to: a. instrument sterilization in one of nine operating rooms. Facility staff were using a quick sterilization method (flash) for instruments used by two physicians, resulting in the potential for use of improperly sterilized instruments and the spread of infectious diseases during surgical procedures (refer to A749, A276); b. temperature and humidity monitoring in the GI and Cardiac Catheterization settings (refer to A749, A275, A951, A940); c. the policy and procedure for OR attire, as facility staff were observed entering restrictive aread of the operating room wearing personal/home laundered clothing and hair covers (refer to A749, A951, A940); d. cleaning of reusable patient equipment. One SPD Technician was observed not following manufacturer's instructions for contact time (refer to A749, A951, A940); and e. handling and processing of sterile equipment. Policy and Procedures were unavailable for sterile instrument presoak and washing and one SPD Tech was unaware of the correct concentration of wash or the type of wash used for prewashing sterile instruments (refer to A749, A951, A940); f. the correct mixing of solution for cleaning of instruments by RT staff, the correct contact time of cleaning solution used in the OR after a surgical case, and the correct mixing of solution and contact time for cleaning of equipment, such as an IV pump, in the SPD area (A 749); 2. expired invasive equipment was not stored in the cardiac catheterization laboratory. Three guide wires were found stored in the cardiac catheterization storage cabinet and available for use, resulting in the potential to spread infections during cardiac catheterizations (refer to A749, A951, A940); 3, on going integration of an infection control program involving food service and sanitation to ensure food safety and sanitation of food service operations (refer to A749, A951, A940); and 4. the air vents were kept clean and free fom dust and debris, resulting in dust and debri particles falling on top of patients during a test of the fire alarm system in the emergency room (refer to A749). The cumulative effects of this systemic problem resulted in the hospital's inability to ensure the provision of an infection control program in a safe and effective manner, placing the patients at risk for hospital aquired infections.

Violation Name: INFECTION CONTROL PROGRAM(A-0749)

• Inspection Date: 2011-04-27 (Event ID: TWDS11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** 18918 Based on observation, interview and record review, the hospital's infection control officer failed to have a system to identify deficient infection control practices relating to: 1. instrument sterilization in one of nine operating rooms. Facility staff were using a quick sterilization method (flash) for instruments used by two physicians. This resulted in the potential for use of improperly sterilized instruments and the spread of infectious diseases during surgical procedures; 2. temperature and humidity monitoring in the GI and Cardiac Catheterization settings (areas identified by AORN, as surgical and invasive procedure settings). This resulted in the potential for patients being at risk for infections; 3. the policy and procedure for OR attire. Facility staff were observed entering restrictive areas of the OR wearing personal/home laundered clothing and hair covers. This failure resulted in the facility placing patients at risk for health care-associated infection; 4. cleaning of reusable patient equipment. One SPD Technician was observed not following manufacturer's instructions for contact time. This resulted in the potential to spread infections; 5. handling and processing of sterile equipment. Policy and Procedures were unavailable for sterile instrument presoak and washing and one SPD Tech was unaware of the correct concentration of wash or the type of wash used for prewashing sterile instruments; 6. storage of expired invasive equipment in the cardiac catheterization laboratory. Three guide wires were found stored in the cardiac catheterization storage cabinet and available for use. This resulted in the potential to spread infections during cardiac catheterizations; 7. the correct mixing of solution for cleaning of instruments by RT staff; 8. the correct contact time of cleaning solution used in the OR after a surgical case; 9. the correct mixing of solution and contact time for cleaning of equipment, such as an IV pump, in the SPD area; 10. on going integration of an infection control program involving food service and sanitation to ensure food safety and sanitation of food service operations; and 11 maintaining the air vents clean and free from dust and debris. This resulted in dust and debris particles falling on top of patients during a test of the fire alarm system in the emergency room . Findings: 1. On [DATE], at 2 p.m., a tour of the OR was conducted. The restrictive area of the department was identified with a red stripe on the floor. There were nine operating rooms and six flash sterilizers. According to the AORN 2009 Perioperative Standards and Recommended Practices: Use of flash sterilization should be kept to a minimum and flash sterilization should be used only in selected clinical situations and in a controlled manner). Each flash sterilizer had a log with documentation of run cycles nearby. The flash sterilization log for sterilizer six was reviewed on [DATE]. There was documentation that a special spinal tray was flash sterilized due to not enough trays/singles. On [DATE], at 2 p.m., OR RN 1 was interviewed. OR RN 1 stated two specialty trays used by two different surgeons were not sent to the SPD for sterilization. According to the RN, the trays contained instruments that were not available in sufficient quantities to make up more than one tray for each surgeon. OR RN 1 stated these trays were sent to SPD for decontamination and cleaning then flash sterilized in the OR prior to surgery. OR RN 1 stated she had been flash sterilizing these specialty trays for six years. In an interview with the SPD Manager on [DATE], at 2:15 p.m., the manager stated to ensure sterility of instruments the items in a tray should be undergoing sterilization after each use. The SPD manager stated the two specialty trays were not being sent to SPD for sterilization. The sterilization logs and flash control strips for sterilizer six were reviewed on [DATE]. Specialty trays identified as either Dr. A tray, or Dr. B tray, were documented as being flash sterilized on the following dates: February 7, 2011, at 5:46 a.m.; February 8, 2011, at 5:24 a.m., and 10:48 a.m.; February 9, 2011, at 5:05 a.m.; February 10, 2011, at 5:43 a.m., 12:03 a.m., and 2:29 p.m.; February 11, 2011, at 5:59 a.m.; February 15, 2011, at 6:12 a.m., 10:48 a.m., and 11:58 a.m.; February 17, 2011 at 5:27 a.m.; February 18, 2011, at 5:54 a.m., and 7:42 a.m.; February 22, 2011, at 5:13 a.m., and 10:42 a.m.; February 24, 2011, at 5:30 a.m., and 9:52 a.m.; [DATE], at 6:02 a.m.; [DATE], at 5:37 a.m., 11:17 a.m., and 3:05 p.m.; [DATE], at 6:11 a.m.; [DATE], at 5:52 a.m., and 1:14 p.m.; [DATE], at 6:09 a.m., and 10:41 a.m.; [DATE], at 5:03 a.m.; [DATE], at 6:23 a.m.; [DATE], at 6:13 a.m., and 10:30 a.m.; [DATE], at 5:28 a.m.; [DATE], 8:24 a.m.; [DATE], at 5:31 a.m., 9:02 a.m., and 10:37 a.m.; [DATE], at 10:24 a.m.; [DATE], at 12:44 p.m., and; [DATE], at 5:46 a.m. Each of these entries on the sterilizer log indicated not enough trays/singles, as the reason for the flash sterilization. In an interview with the SPD Manager on [DATE], at 2:30 p.m., the manager stated she had identified the overuse of flash sterilization and notified the OR Director in 2010. The manager stated she was attempting to obtain additional instruments but some were on back order and she did not have all the items required to make complete trays. On [DATE], at 4 p.m., the VP of Quality, Patient Safety and Risk Management was interviewed. The VP stated the specialty trays should be cleaned and sterilized in SPD and she was unaware it was not being done as directed by policy. The Chief of the Medical Staff was interviewed by phone on [DATE], at 4:15 p.m. He was unaware of the special spinal trays for the two spine physicians undergoing repeated flash sterilizations without full sterile processing. The facility's policy and procedure titled Sterilization-Steam Using Unwrapped Method (Flash Sterilization) with a last revised date of [DATE] was reviewed on [DATE]. The policy indicated flash sterilization would only be used when there was insufficient time to process by the preferred wrapped or container method. According to the policy flash sterilization would not be used as a substitute for insufficient instrument inventory. The policy and procedure indicated references used included AORN (2009) Standards and Recommended Practices. The facility's policy and procedure titled Steam Sterilization, with a revision date of [DATE], was reviewed on [DATE]. The policy indicated the creation and maintenance of aseptic environments had a direct influence on patient outcomes. The policy indicated measures for preventing surgical wound infections included Provision of instrumentation, supplies, and equipment free of contamination at the time of use. Sterilization provides the highest level of assurance that an object is free of viable microbes. According to the policy, steam sterilization was a process that utilized saturated steam under pressure, for a specific exposure time and at a specified temperature, as a sterilizing agent. Items to be sterilized are those that enter sterile tissue or the vascular system. In an interview with the Director of Surgical Services and the COO, on [DATE], at 9:15 a.m., they stated they were unaware these specialty trays were not being sent to SPD for processing. Both agreed the items should go through the presoaking, cleaning and steam sterilization process before use. The Surgical Director stated the decision to flash the equipment in the operating room was made by the ortho resource nurse. During an interview with the Manager of Infection Control, on [DATE], at 10:30 a.m., the manager agreed that instruments should be sent to SPD for clearing and sterilization. The Infection Control meeting minutes (Treatment and Surveillance Committee) from [DATE], through February 2011 were reviewed. 2. On [DATE], at 1:45 p.m., a tour of the Gastrointestinal (GI) lab was conducted with the manager. The area consisted of three procedure rooms, a decontamination room, pre procedure and post procedure beds and a nursing station. The manager stated they performed about 20 procedures daily. During a tour of procedure room [ROOM NUMBER] there was a cabinet for storage of endoscopes (an instrument used to examine the interior of a hollow organ or cavity of the body, for example the colon or the esophagus). The cabinet was enclosed and vented to allow for drying of the endoscopes after processing. There was a thermostat on the wall that indicated the room temperature was 70? Fahrenheit. In an interview with the manager, on [DATE], at 2 p.m., the manager stated they were not monitoring humidity at this time, just temperatures. On [DATE], at 9:15 a.m., during an interview with the manager of the GI lab, the manager stated while there was a thermostat on the wall, unit personnel did not monitor room temperatures. The manager also stated there was no way of monitoring room humidity. Record review for Patient 208 was conducted on [DATE]. Patient 208 underwent a colonoscopy (examination of the colon and part of the small bowel with a flexible tube passed through the rectum). Patient 208 underwent this procedure under moderate sedation (conscious sedation- administering sedatives or dissociative agents with or without analgesics to induce a state that allows the patient to tolerate unpleasant procedures while maintaining cardiorespiratory function). In an interview with the VP of Quality on [DATE], at 9:30 a.m., the VP stated she was unaware additional areas of the hospital required temperature and humidity monitoring. On [DATE], at 12:30 p.m., an interview was conducted in the cardiac catheterization lab with the Cath Lab Coordinator and RN 209. RN 209 stated they were not monitoring temperature and humidity levels in the cath lab procedure rooms. During an interview with the VP of Quality on [DATE], at 12:45 p.m., the VP stated she had identified that monitoring of temperatures and humidity was not being done in the cath lab. On [DATE], the temperature and humidity logs were reviewed. There was no documentation in the log books that indicated temperature and humidity of the GI procedure rooms and cardiac catheterization rooms was monitored. The facility policy and procedure titled Temperature and Humidity Control in Operating Suites, with a last revision date of [DATE], was reviewed on [DATE]. The policy and procedure indicated Operating suites were defined as operating room and labor and delivery areas. The policy did not specify any additional procedural areas as requiring daily monitoring. The document listed as a reference AORN (2009) Perioperative Standards and Recommended Practices including Safe Environment of Care. According to the AORN 2009 Perioperative Standards and Recommended Practices: The Mission was to promote safety and optimal outcomes for patients undergoing operative and other invasive procedures. In the section for Recommended Practices for Safe Environment of Care, AORN indicated the practice guidelines were adaptable to various practice settings including traditional operating rooms, cardiac catheterization laboratories, endoscopy suites, and all other areas where surgery could be performed. Recommendation V indicated: Relative humidity should be maintained between 30 % and 60 % within perioperative suite, including operating rooms, recovery area, cardiac catheterization rooms, endoscopy rooms, instrument processing areas. High humidity increases the risk of microbial growth in areas where sterile supplies are stored or procedures are performed. Recommendations indicated temperature and humidity should be monitored and recorded daily. 3. On [DATE], at 2:30 p.m., two facility staff were observed in the restrictive area of the operating rooms wearing personal hats. On [DATE], at 3:30 p.m., the SPD Manager was observed in the SPD department wearing a personal scrub hat. (SPD was not in the restrictive area at the time). In a concurrent interview, the SPD manager stated there was no policy about wearing personal scrub attire, but she washed the hat daily. On [DATE], at 9:15 a.m., the Director of Surgical Services was interviewed in a facility conference room. The director stated the corporation's consultant was reviewing recent information about home laundered/personal scrub attire, but the AORN standards were unclear and there was no definitive answer. The facility policy and procedure titled ATTIRE IN THE OPERATING ROOM, with a last revision date of [DATE], was reviewed on [DATE]. The policy indicated it applied to all persons authorized to enter the restrictive areas of the operating room. The policy indicated Persons entering the restrictive areas of the Operating Room will wear approved, hospital supplies, clean Operating Room apparel. The policy indicated AORN Standards, Recommended Practices and Guidelines for Surgical Attire (2006) was a reference. According to the AORN 2009 Perioperative Standards and Recommended Practices: All individuals who enter the semirestricted and restricted areas of the surgical suite should wear freshly laundered surgical attire intended for use only within the surgical suite. The recommended practices indicated AORN did not support the practice of home laundering of surgical attire. Reususable scrub attire, including cover jackets and cloth hats, should be laundered by a designated facility approved and monitored commercial laundry after daily use. During an interview with the Manager of Infection Control, on [DATE], at 10:30 a.m., the manager stated personal scrub attire was an issue. 4. On [DATE], at 10 a.m., SPD Tech 2 was observed cleaning reusable patient equipment in the D3 dirty utility room. SPD Tech 2 poured solution from a bottle of MicrocleansePlus onto several cloth washcloths and used one wash cloth to wipe down a pump for infusing intravenous fluids. The wash cloth was not saturated with solution and the equipment appeared dry on contact. After cleaning the equipment, a green sticker indicating the piece was Clean, was placed on it and it was transferred into the clean storage room. The facility's policy and procedure for Cleaning Patient Equipment, with an origination date of [DATE], was reviewed on [DATE]. The policy was Under Review, Pending Approval. The policy indicated it applied to all staff that handle reusable patient equipment, such as IV pumps and sequential compressive devices. According to the policy: Cleaning will be done with hospital approved germicidal according to manufactures guideline. In an interview with the Infection Control Manager and VP of Quality on [DATE], at 1 p.m., the Infection Control Manager stated the cleanser used to clean equipment had a five minute contact time. The manufacturer's information for MircorcelansePlus was reviewed on [DATE]. Instructions indicated: To achieve maximum affect allow surface to remain wet for 5 minutes . 20914 5. Central processing was toured on [DATE], at 10 a.m. Certified SPD Technician A was seen in the pre-wash area and was interviewed. She explained that for the soaking and hand wash of surgical instruments prior to sterilization, she would add water to the sink to a level that covered the tray and instruments well. She did not use a measured amount of water. In order to reach that mixture, she stated she used, about a medicine cup, (which holds one ounce) of solution, and just made sure there was enough water to cover the instruments, but did not measure the water. The label of the product she was using was examined on [DATE]. The product was Steris Prolystica Ultra Concentrate. The instructions were for use only in mechanical washing systems. There was no mention of use in instrument hand washing. The amount to be used was less than a milliliter per gallon. The manufacturer recommendations indicated it was meant to be automatically dispensed using an automatic mixing process, not mixed by the SPD technician. The manufacturer recommended a mixture of ,d+[DATE]-,d+[DATE] of an ounce for every gallon of water (,d+[DATE] times less concentrated than the technician was mixing). During a concurrent interview, Certified SPD Technician A, stated she could not explain how she came to be using this product in this way. Most products used to clean surgical instruments are enzymatic cleaners (contain enzymes that break down the protein in biological material). This label did not mention any enzymatic ingredients of activity. There were no signs posted at the station with the pre-wash procedure and she could not cite any policy that she was following. The Director of the SPD was interviewed on on [DATE], at 10 a.m. The Director seemed unaware of the fact that the technician was using a product not recommended for instrument soaking and prewash by the manufacturer. She also did not seem aware that the concentration being used was not known and no policy was being followed. A policy on instrument soaking and hand washing was requested several times but not produced by the hospital. The Manager of Infection Control (IC), the Infection Control nurse and the Director of Quality, Safety and Risk were jointly interviewed on [DATE], at 1p.m. They were unaware of these issues. It was discussed that this issue should have been identified by the IC staff. The three staff members all agreed. 6. The Interventional Radiology Suite was toured on [DATE], at 11:05 a.m. The room was lined with cabinets containing catheters, wires and other instruments used in the procedures. The cabinets were inspected and three expired wires were found. The first, a Cook VAD 2 had expired February 2011, more than six weeks before the survey. The other two, Cook JB 2, had expired in [DATE]. The Director of Radiology was interviewed on [DATE], at 11:05 a.m. and stated all of the techs checked for expired products each time they accessed the cabinets but there was no individual responsible for checking the entire inventory at any set frequency. She stated there was no policy for the checking of outdated products and instruments. The Manager of Infection Control (IC), the Infection Control nurse and the Director of Quality, Safety and Risk were jointly interviewed on [DATE], at 1 p.m. They were unaware of the issue. It was discussed that this issue should have been identified by the IC staff. The three staff members all agreed. 21898 11. On [DATE], at 10:42 a.m., while the fire alarm system in the Emergency Department was being tested , it was observed that dust and debris discharged from the vent in the ceiling in Exam Room C186. Four patients came out of the Exam Room wiping dust and debris from their clothes. The vent was observed to be covered in dust and debris as well as the floor, chair and exam bed. When interviewed on [DATE] at 10:42 a.m., the patients stated that dust and debris had fallen on them while sitting in the Exam Room. In an interview with a nursing staff, on [DATE], at 11:15 a.m., the nurse stated housekeeping was responsible for cleaning the vents. In an interview with the housekeeper, on [DATE], at 11:20 a.m., the housekeeper stated her department did not clean the air vents. A tour of the ED indicated there were several other vents that were coated with dust. 22764 7. During an interview with the RT equipment technician, the technician stated he cleaned instruments with an enzymatic solution called Prolystica. He stated when he mixed the solution for cleaning the instruments, he would, visualize, the water level, and, eyeball, the amount of enzymatic solution he added. According to the Prolystica manufacturer recommendations, the solution should be mixed using ,d+[DATE] ounce of solution in one gallon of water. 8. During a tour of the OR on [DATE], at 3 p.m., the OR EVS employee explained how she cleaned a room after a surgical case. She stated she used a solution in a spray bottle called Phenolic Disinfectant Cleaner. She stated she would sometimes spray and wipe the solution off, and other times she would wet a towel and use that. The EVS employee stated the contact time (amount of time she allowed the surfaces to remain wet) depended on the type of surgical procedure that had been done, if it was a, normal, case, she would spray the surfaces and wipe them off right away, but if it was an, infected, case, she would allow a contact time of 15 minutes. According to the manufacturer recommendations, the Phenolic Spray solution should remain of the surfaces for a minimum of 10 minutes for effective disinfection. 9. During a tour of the SPD area on [DATE], SPD Technician 2 was observed cleaning an IV pump. He stated he cleaned the equipment with a solution called Microcleanse. He stated he mixed it himself using four quarts of water and, a little bit of microcleanse. He stated he used ,d+[DATE] of a medicine cup (equal to ,d+[DATE] ounce) of the solution, which he defined as one ounce. The technician stated he cleaned the equipment and wiped the solution off right away. He stated he did not know if there was a required contact time (amount of time he allowed the surfaces to remain wet). According to the manufacturer recommendations for Microcleanse, 6 ,d+[DATE] ounces of water should be added to each gallon of water (13 times more than the technician was using). The manufacturer also recommended, to achieve maximum effect, the surface should remain wet for five minutes. 27157 10. During the course of the survey, unsafe and unsanitary issues were identified in the kitchen which involved potentially hazardous foods were not consistently cooled down, a lingering sewage smell was not comprehensively addressed by hospital staff, and the ice machines were not being sanitized. Failure to provide a safe and sanitary environment may result in food borne illness, and may further compromise patients' medical status. (Cross Reference A-0620) On [DATE] at 2:25 p.m., the ICN stated she was not aware of the above identified concerns that had the potential to result in a foodborne illness. The ICN acknowledged the food and nutrition services should have reported the odor that smelled like sewage to the ICN. The ICN stated she had been employed in the specific role of the designated infection control nurse for the hospital for one year. The ICN stated the only role that she had been involved in with the food and nutrition services department was a hand washing in-service that was provided to the dietary staff that delivers meal trays to patients. The former ICN was present during the interview and stated the last environment round that was done involving the ICN and the food and nutrition department was three years ago. The ICN acknowledged the hospital did not have an active mechanism in place in which surveillance, reporting, monitoring and prevention aspects would be integrated with the food and nutrition department. The improper cooling down practices of potentially hazardous foods by dietary staff was identified at [name of hospital] five years earlier, and was still being done incorrectly. Excessive time for cooling of potentially hazardous foods has been consistently identified as one of the leading contributing factors to foodborne illness. (FDA Food Code 2009) During the same interview, the ICN stated there was not a process in place for the Infection Prevention and Control Program to be involved in monitoring or approving chemicals used for the ice-machines. The ICN was unaware that the ice-machines were not being sanitized. The hospital's PROCEDURES/GUIDELINES entitled INFECTION CONTROL PLAN (Last revised ,d+[DATE]) indicated, The Infection Prevention & Control Program is a multidisciplinary, systemic approach to quality patient care that emphasizes risk reduction of disease transmission in a health care environment by using sound epidemiological principles ., to analyze practices that have the potential to affect rates of health care associated infections The Infection Prevention & Control Program is divided into functional groups of routine activities that address the integrated faucets of surveillance (observation, monitoring, and evaluation) .

Violation Name: SURGICAL SERVICES(A-0940)

• Inspection Date: 2011-04-27 (Event ID: TWDS11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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18918 Based on observation, interview and record review, the facility to provide safe surgical services in accordance with acceptable standards of practice as evidenced by: 1. The failure of the facility to maintain and enforce policies and procedures for sterilization of surgical instruments. Two specialty spinal trays (that included multiple instruments) were flash sterilized daily and did not undergo steam sterilization prior to scheduled spinal surgeries. This failure resulted in the potential use of improperly sterilized instruments and the spread of infectious diseases during surgical procedures. (Refer to A951, item 1); 2. The failure of the facility to monitor temperature and humidity in all areas used for surgical or invasive procedures. The facility failed to monitor temperature and humidity in three of GI lab procedure rooms and three of three cardiac catheterization rooms. This failure placed patients at risk for infections and injury due to flash fires. (Refer to A951, item 2); 3. The failure of the facility to implement their policy and procedure for surgical attire. Three staff working in restrictive areas were observed wearing personal, non facility furnished attire (scrub hats). This failure resulted in the facility placing patients at risk for health care-associated infection. (Refer to A951, item 3) The cumulative effects of this systemic problem resulted in the hospital's inability to ensure the provision of surgical services in a safe and effective manner.

Violation Name: OPERATING ROOM POLICIES(A-0951)

• Inspection Date: 2011-04-27 (Event ID: TWDS11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** 18918 Based on observation, interview, and document review, the facility failed to: 1. ensure policy and procedures for instrument sterilization was followed in one of ten operating rooms by using a quick sterilization method (flash) for instruments used by two physicians. This resulted in the potential for use of improperly sterilized instruments and the spread of infectious diseases during surgical procedures; 2. ensure temperature and humidity was monitored, and corrective actions taken in the GI and Cardiac Catheterization settings (areas identified by AORN, as surgical and invasive procedure settings), resulting in the potential for patients at risk for infections and injuries due to fires; and 3. ensure the policy and procedure for OR attire was followed by allowing three staff to wear personal/home laundered clothing and hair covers in the restrictive areas of the Operating Room. This failure resulted in the facility placing patients at risk for health care-associated infection. Findings: 1. On April 18, 2011, at 2 p.m., a tour of the OR was conducted. The restrictive area of the department was identified with a red stripe on the floor. There were nine operating rooms and six flash sterilizers. According to the AORN 2009 Perioperative Standards and Recommended Practices: Use of flash sterilization should be kept to a minimum and flash sterilization should be used only in selected clinical situations and in a controlled manner). Each flash sterilizer had a log with documentation of run cycles nearby. The flash sterilization log for sterilizer six was reviewed on April 18, 2011. There was documentation that a special spinal tray was flash sterilized due to not enough trays/singles. On April 20, 2011, at 2 p.m., OR RN 1 was interviewed. OR RN 1 stated two specialty trays used by two different surgeons were not sent to the SPD for sterilization. According to the RN, the trays contained instruments that were not available in sufficient quantities to make up more than one tray for each surgeon. OR RN 1 stated these trays were sent to SPD for decontamination and cleaning then flash sterilized in the OR prior to surgery. OR RN 1 stated she had been flash sterilizing these specialty trays for six years. In an interview with the SPD Manager on April 20, 2011, at 2:15 p.m., the manager stated to ensure sterility of instruments the items in a tray should be undergoing sterilization after each use. The SPD manager stated the two specialty trays were not being sent to SPD for sterilization. The sterilization logs and flash control strips for sterilizer six were reviewed on April 20, 2011. Specialty trays identified as either Dr. A tray, or Dr. B tray, were documented as being flash sterilized on the following dates: February 7, 2011, at 5:46 a.m.; February 8, 2011, at 5:24 a.m., and 10:48 a.m.; February 9, 2011, at 5:05 a.m.; February 10, 2011, at 5:43 a.m., 12:03 a.m., and 2:29 p.m.; February 11, 2011, at 5:59 a.m.; February 15, 2011, at 6:12 a.m., 10:48 a.m., and 11:58 a.m.; February 17, 2011 at 5:27 a.m.; February 18, 2011, at 5:54 a.m., and 7:42 a.m.; February 22, 2011, at 5:13 a.m., and 10:42 a.m.; February 24, 2011, at 5:30 a.m., and 9:52 a.m.; March 1, 2011, at 6:02 a.m.; March 3, 2011, at 5:37 a.m., 11:17 a.m., and 3:05 p.m.; March 7, 2011, at 6:11 a.m.; March 8, 2011, at 5:52 a.m., and 1:14 p.m.; March 10, 2011, at 6:09 a.m., and 10:41 a.m.; March 14, 2011, at 5:03 a.m.; March 17, 2011, at 6:23 a.m.; March 18, 2011, at 6:13 a.m., and 10:30 a.m.; March 22, 2011, at 5:28 a.m.; March 23, 2011, 8:24 a.m.; March 24, 2011, at 5:31 a.m., 9:02 a.m., and 10:37 a.m.; March 28, 2011, at 10:24 a.m.; March 29, 2011, at 12:44 p.m., and; March 30, 2011, at 5:46 a.m. Each of these entries on the sterilizer log indicated not enough trays/singles, as the reason for the flash sterilization. In an interview with the SPD Manager on April 20, 2011, at 2:30 p.m., the manager stated she had identified the overuse of flash sterilization and notified the OR Director in 2010. The manager stated she was attempting to obtain additional instruments but some were on back order and she did not have all the items required to make complete trays. On April 20, 2011, at 4 p.m., the VP of Quality, Patient Safety and Risk Management was interviewed. The VP stated the specialty trays should be cleaned and sterilized in SPD and she was unaware it was not being done. The Chief of the Medical Staff was interviewed by phone on April 20, 2011, at 4:15 p.m. He was unaware of the special spinal trays for the two spine physicians undergoing repeated flash sterilizations without full sterile processing. The facility's policy and procedure titled Sterilization-Steam Using Unwrapped Method (Flash Sterilization) with a last revised date of August 2009 was reviewed on April 20, 2011. The policy indicated flash sterilization would only be used when there was insufficient time to process by the preferred wrapped or container method. According to the policy flash sterilization would not be used as a substitute for insufficient instrument inventory. The policy and procedure indicated references used included AORN (2009) Standards and Recommended Practices. The facility's policy and procedure titled Steam Sterilization, with a revision date of August 2009, was reviewed on April 20, 2011. The policy indicated the creation and maintenance of aseptic environments had a direct influence on patient outcomes. The policy indicated measures for preventing surgical wound infections included Provision of instrumentation, supplies, and equipment free of contamination at the time of use. Sterilization provides the highest level of assurance that an object is free of viable microbes. According to the policy, steam sterilization was a process that utilized saturated steam under pressure, for a specific exposure time and at a specified temperature, as a sterilizing agent. Items to be sterilized are those that enter sterile tissue or the vascular system. In an interview with the Director of Surgical Services and the COO, on April 21, 2011, at 9:15 a.m., they stated they were unaware these specialty trays were not being sent to SPD for processing. Both agreed the items should go through the presoaking, cleaning and steam sterilization process before use. The Surgical Director stated the decision to flash the equipment in the operating room was made by the ortho resource nurse. 2. On April 19, 2011, at 1:45 p.m., a tour of the GI lab was conducted with the manager. The area consisted of three procedure rooms, a decontamination room, pre procedure and post procedure beds and a nursing station. The manager stated they performed about 20 procedures daily. During a tour of procedure room [ROOM NUMBER] there was a cabinet for storage of endoscopes (an instrument used to examine the interior of a hollow organ or cavity of the body, for example the colon or the esophagus). The cabinet was enclosed and vented to allow for drying of the endoscopes after processing. There was a thermostat on the wall that indicated the room temperature was 70? Fahrenheit. In an interview with the manager, on April 19, 2011, at 2 p.m., the manager stated they were not monitoring humidity at this time, just temperatures. On April 20, 2011, at 9:15 a.m., during an interview with the manager of the GI lab, the manager stated while there was a thermostat on the wall, unit personnel did not monitor room temperatures. The manager also stated there was no way of monitoring room humidity. The manager stated patients undergoing procedures were given oxygen during the procedure and a cautery device was occasionally used. Record review for Patient 208 was conducted on April 19, 2011. Patient 208 underwent a colonoscopy (examination of the colon and part of the small bowel with a flexible tube passed through the rectum). Patient 208 underwent this procedure under moderate sedation (conscious sedation- administering sedatives or dissociative agents with or without analgesics to induce a state that allows the patient to tolerate unpleasant procedures while maintaining cardiorespiratory function). In an interview with the VP of Quality on April 20, 2011, at 9:30 a.m., the VP stated she was unaware additional areas of the hospital required temperature and humidity monitoring. On April 21, 2011, at 12:30 p.m., an interview was conducted in the cardiac catheterization lab with the Cath Lab Coordinator and RN 209. RN 209 stated they were not monitoring temperature and humidity levels in the cath lab procedure rooms. During an interview with the VP of Quality on April 21, 2011, at 12:45 p.m., the VP stated monitoring of temperatures and humidity was not being done in the cath lab. On April 21, 2011, the temperature and humidity logs were reviewed. There was no documentation in the log books that indicated temperature and humidity of the GI procedure rooms and cardiac catheterization rooms was monitored. The facility policy and procedure titled Temperature and Humidity Control in Operating Suites, with a last revision date of July 2010, was reviewed on April 21, 2011. The policy and procedure indicated Operating suites were defined as operating room and labor and delivery areas. The policy did not specify any additional procedural areas as requiring daily monitoring. The document listed as a reference AORN (2009) Perioperative Standards and Recommended Practices including Safe Environment of Care. According to the AORN 2009 Perioperative Standards and Recommended Practices: The Mission was to promote safety and optimal outcomes for patients undergoing operative and other invasive procedures. In the section for Recommended Practices for Safe Environment of Care, AORN indicated the practice guidelines were adaptable to various practice settings including traditional operating rooms, cardiac catheterization laboratories, endoscopy suites, and all other areas w.ere surgery could be performed. Recommendation V indicated: Relative humidity should be maintained between 30 % and 60 % within perioperative suite, including operating rooms, recovery area, cardiac catheterization rooms, endoscopy rooms, instrument processing areas. Low humidity increases the risk for fire hazards, while high humidity increases the risk of microbial growth in areas where sterile supplies are stored or procedures are performed. Recommendations indicated temperature and humidity should be monitored and recorded daily. 3. During a tour of the OR on April 19, 2011, at 2:20 p.m., accompanied by the Trauma Coordinator Nurse, the nurse attempted to obtain a, bunny suit, to cover her uniform worn from home prior to entering the OR. The PACU Manager told the nurse she could enter the OR without covering up. The nurse was observed entering the OR in her uniform worn from home. On April 19, 2011, at 2:30 p.m., two facility staff were observed in the restrictive area of the operating rooms wearing personal hats. On April 20, 2011, at 3:30 p.m., the SPD Manager was observed in the SPD department wearing a personal scrub hat. (SPD was not in the restrictive area at the time). In a concurrent interview, the SPD manager stated there was no policy about wearing personal scrub attire, but she washed the hat daily. On April 21, 2011, at 9:15 a.m., the Director of Surgical Services was interviewed in a facility conference room. The director stated the corporation's consultant was reviewing recent information about home laundered/personal scrub attire, but the AORN standards were unclear and there was no definitive answer. The facility policy and procedure titled ATTIRE IN THE OPERATING ROOM, with a last revision date of July 2006, was reviewed on April 21, 2011. The policy indicated it applied to all persons authorized to enter the restrictive areas of the operating room. The policy indicated Persons entering the restrictive areas of the Operating Room will wear approved, hospital supplies, clean Operating Room apparel. The policy indicated AORN Standards, Recommended Practices and Guidelines for Surgical Attire (2006) was a reference. According to the AORN 2009 Perioperative Standards and Recommended Practices: All individuals who enter the semi-restricted and restricted areas of the surgical suite should wear freshly laundered surgical attire intended for use only within the surgical suite. The recommended practices indicated AORN did not support the practice of home laundering of surgical attire. Reusable scrub attire, including cover jackets and cloth hats, should be laundered by a designated facility approved and monitored commercial laundry after daily use. During an interview with the Manager of Infection Control, on April 21, 2011, at 10:30 a.m., the manager stated personal scrub attire was an issue.

Violation Name: FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE(A-0724)

• Inspection Date: 2011-04-27 (Event ID: TWDS11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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27157 Based on observation, interview and record review, the hospital failed to: 1. maintain sufficient emergency water supply in the event of a disaster and 2. maintain a walk-in freezer located in the kitchen in good condition. Findings: 1. On April 25, 2011, at 1:25 p.m., the GMMS stated the hospital's emergency water supply was planned for 1500 people for 5 days at a quantity of one quart per person per day. The GMMS stated the American Red Cross was the hospital's community standard of reference for recommendations on emergency water supply. The hospital's policy and procedure entitled CODE TRIAGE -EMERGENCY MASS FEEDING PLAN for the Nutritional Services department indicated, Policy: Refer to Engineering policy regarding emergency water supply .,Procedure: To provide for basic nutrition and hydration needs to inpatients, employees and emergency personnel in the event of a disaster, including but not limited to , major earthquake, fire, flood or terrorist attack. The department of Engineering P&P entitled FAILURE OF WATER DISTRIBUTION SYSTEM indicated, In the event of a total failure, backup water supply is available through: a. on-site bottled water and b. contractual supply from outside vendor. The hospital's DISASTER PLAN; NUTRITIONAL SERVICES (last reviewed 4/10), page 8, indicated, The hospital's source of potable water is obtained from Engineering ., Dishwashing will be limited to cooking pots, utensils, and the sanitizing of trays. According to the hospital's DISASTER PLAN; NUTRITIONAL SERVICES, page 13, indicated, An emergency may interrupt the supply of safe drinking water. It is advisable to have adequate quantities of canned water in storage. One quart of water per person per day is essential. Two quarts of water per person per day allows some water for cooking. In review of the hospital's disaster menu, there were items incorporated that would require water for preparation. The hospital's DISASTER PLAN; NUTRITIONAL SERVICES, page 22, indicated To obtain emergency water, nutritional services will maintain contact with the Engineering Department to supply an adequate amount of bottle water. The hospital failed to ensure an acceptable level of emergency water supply to meet its patients' needs in the event of a disaster. The hospital's planned water supply for one quart of water per person per day was not consistent with community standards of practice. In addition, the hospital's disaster policies and procedures addressed some drinking, menu planning and pot and pan needs for emergency water supply. The hospital's disaster water plan did not indicate that the hospital identified the supply of water it would need to meet the hygiene needs, fluid needs of the highly susceptible fragile population with accompanying medical needs not limited to tube feeding and medication flushes, wound care needs, and incontinence. 2. On April 25, 2011, at 11:05 a.m., inside the walk-in freezer in the kitchen was thick condensation build-up that covered the ceiling of the freezer, and on the floor of the freezer. There were boxes of frozen food stacked high in close proximity to the ceiling of the freezer. The external thermometer of the freezer indicated, 25 - 30 degrees F. There was a delivery of food that was being put away at that time. There was no internal thermometer inside the freezer, verified by the Executive Chef. The GMMS observed the excessive condensation and stated the ice-build up should have been removed. On April 25, 2011, at 2:31 p.m., the external thermometer for the freezer indicated 10 degrees F. On April 25, 2011, at 3:30 p.m., Engineering Staff 1 observed the thick condensation build-up inside the walk-in freezer. Engineering Staff 1 acknowledged that if the freezer was working correctly, under normal conditions, then the build-up of condensation that was currently present would not have been expected. A record review of work orders that were placed by the dietary department, in regard to the walk-in freezer not working properly, indicated that the issue was reported eight times to the engineering department in 2010. The dietary department had placed five work orders in 2011 to the engineering department due to the freezer had elevated temperatures. The dietary department was aware that the freezer was prone to excessive temperatures, and yet had not ensured that an internal thermometer was located inside the freezer, and had not increased temperature monitoring to ensure food safety. On April 26, 2011, at 9:30 a.m., the Manager of Engineering stated there had been no preventative maintenance completed on the walk-in freezer located in the kitchen from January 2010 until current. The Manager of Engineering acknowledged that if preventative maintenance had been incorporated into a routine schedule for the walk-in freezer that problems identified would have been caught sooner. The Manager of Engineering was unable to explain why the walk-in freezer had excessive build up of thick ice with temperatures exceeding 0 degrees F. The hospital failed to ensure that the walk-in freezer was operating in good condition throughout the day to ensure food quality, and food safety.

Violation Name: PATIENT RIGHTS: RESTRAINT OR SECLUSION(A-0169)

• Inspection Date: 2011-04-27 (Event ID: TWDS11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** 18918 Based on observation, interview and record review, the hospital failed to ensure orders for the use of restraints were not written on an as needed basis for one of five sampled patients (Patient 200) in restraints. This resulted in the potential for the patient to be restrained without clinical justification for use, the duration of use and the behavior based criteria for use. Findings: During facility tour on April 18, 2011, at 10:45 a.m., the unit director stated there was one patient with restraints earlier, but the restraints had been removed. The unit director stated the original order for Patient 200 was a PRN order, and the restraints were removed. On April 18, 2011, at 11 a.m., Patient 200 was observed lying in bed. Patient 200 responded quietly and appropriately to questions asked. Patient 200 was not restrained. In an interview with RN 202, on April 18, 2011, at 11 a.m., RN 202 stated Patient 200 had been attempting to remove medical devices, but he was better now. RN 202 stated soft mitten restraints were placed on Patient 200, but he was no longer restrained. The restraint monitoring form posted on the wall was reviewed with RN 202. The form indicated Patient 202 was restrained between 9:15 and 10:15 a.m. The record for Patient 200 was reviewed on April 18, 2011, with the director and manager of Unit D3. Patient 200 was admitted to the facility on [DATE], with diagnoses that included right lower lobe pneumonia (inflamatory condition of the lungs) and acute kidney failure. On April 16, 2011, the following order was written: Soft Restraints PRN. There was no documentation for type, duration, clinical manifestation or behavior criteria for release. On April 18, 2011, the following order was written: Soft Restrains (sic). There was no documentation for type, duration, clinical manifestation or behavior criteria for release. In an interview with the unit director, on April 18, 2011, at 11:15 a.m., the director stated restraint orders cannot be written as a PRN order. The director stated she instructed her staff that as written, the restraint order was invalid and a telephone order was to be obtained. During a review of the record with the director, on April 18, 2011, there was no evidence of a telephone order in the record. The facility's policy and procedure titled Restraint and Seclusion Guidance Policy, with a last revised date of January 2010, was reviewed on April 18, 2011. The policy indicated its purpose was to protect the dignity and safety of inpatients through the safe restraint process and to provide guidelines to define the procedure to be followed when all alternatives have been exhausted and proven ineffective, and restraints are necessary to maintain patient safety. The policy further indicated in Section 5 Order for Restraint, the restraint order must be obtained from an Licensed Independent Practitioner (LIP)/physician who is responsible for the care of the patient prior to the application of the restraint. According to the policy the order must specify clinical justification for the restraint, the date and time ordered, the duration of use, the type of restraint to be used and behavior-based criteria for release. In addition, the policy indicated An order for restraint may not be written as a standing order, protocol or as a PRN or as needed order.

Violation Name: LICENSURE OF PERSONNEL(A-0023)

• Inspection Date: 2011-04-27 (Event ID: TWDS11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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27157 Based on document review and staff interview, the hospital failed to ensure that the GMMS who had the delegated authority by the governing body to be the food service director was full-time and qualified in accordance to State law. Findings: The hospital failed to ensure the GMMS met qualifications according to the Health and Safety Code 1265.4. The hospital failed to meet State law as specified in 70275 (b) in regard to the person responsible for the operation of the food service did not meet the written requirements for qualifications as specified in State and Health and Safety Code 1265.4 law. On April 26, 2011, at 11:45 a.m., based on interview and record review, the GMMS was unable to provide documentation he was qualified for his position in accordance with the Health and Safety Code 1265.4. The GMMS reviewed the Health & Safety Code 1265.4 and stated he did not meet any of the listed pathways to be qualified to be responsible for the operation of the food service in accordance with the law. According to the law, Health and Safety Code 1265.4(b) .A health facility that employs a registered dietitian less than full time, shall also employ a full-time dietetic services supervisor who meets the requirements of subdivision (b) to supervise dietetic service operations. The dietetic services supervisor shall receive frequently scheduled consultation from a qualified dietitian. (b) The dietetic services supervisor shall have completed at least one of the following educational requirements: (1) A baccalaureate degree with major studies in food and nutrition, dietetics, or food management and has one year of experience in the dietetic service of a licensed health facility. (2) A graduate of a dietetic technician training program approved by the American Dietetic Association, accredited by the Commission on Accreditation for Dietetics Education, or currently registered by the Commission on Dietetic Registration. (3) A graduate of a dietetic assistant training program approved by the American Dietetic Association. (4) Is a graduate of a dietetic services training program approved by the Dietary Managers Association and is a certified dietary manager credentialed by the Certifying Board of the Dietary Managers Association, maintains this certification, and has received at least six hours of in-service training on the specific California dietary service requirements contained in Title 22 of the California Code of Regulations prior to assuming full-time duties as a dietetic services supervisor at the health facility. (5) Is a graduate of a college degree program with major studies in food and nutrition, dietetics, food management, culinary arts, or hotel and restaurant management and is a certified dietary manager credentialed by the Certifying Board of the Dietary Managers Association, maintains this certification, and has received at least six hours of in-service training on the specific California dietary service requirements contained in Title 22 of the California Code of Regulations prior to assuming full-time duties as a dietetic services supervisor at the health facility. (6) A graduate of a state approved program that provides 90 or more hours of classroom instruction in dietetic service supervision, or 90 hours or more of combined classroom instruction and instructor led interactive Web-based instruction in dietetic service supervision. (7) Received training experience in food service supervision and management in the military equivalent in content to paragraph (2), (3), or (6). On April 26, 2011, at 11:45 a.m., the GMMS stated he was the general manager of multiple services. The GMMS stated that he spent 20 -30% of his time to provide consultation to the environmental services department. The GMMS stated that he had the authority and responsibility for the operation of the food and dietetic services department. On April 26, 2011, at 1:45 p.m., the COO acknowledged that the GMMS was the person who had the authority and responsibility for the food and nutrition department, and he stated, He's the food service director. On April 27, 2011, at 10:15 a.m., in the hospital's dietary policies and procedures manual was an organization chart entitled Nutritional and Environmental Services Organization Chart. The GMMS had oversight over the food and nutrition department, and also had oversight over the EVS Director. The organizational structure and functions diminished the GMMS to less than full-time over the food and nutrition department. During the same interview the GMMS stated that the dietary department did have a qualified DSS in accordance with the Health and Safety Code 1265.4 However, the GMMS acknowledged that the DSS was not the responsible person for the food service operation. On April 26, 2011, at 1:20 p.m., the dietary staff member who the GMMS referred to as meeting DSS qualifications stated she was the Retail Manager. The Retail Manager stated she was in charge of the cafeteria and retail sales, and was in an equivalent managerial position as the Executive Chef, Patient Service Manager and the person in charge of catering, coffee shop and projects. The Retail Manager stated the GMMS was responsible for the foodservice operation.

Violation Name: GOVERNING BODY(A-0043)

• Inspection Date: 2011-04-27 (Event ID: TWDS11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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21898 Based on observation, interview, and record review, the governing body did not have full oversight of all activities of the hospital. The hospital condition of participation for governing body was not met as evidence by the hospital failing to: Findings: 1. ensure the General Manager of Multiple Services who had the delegated authority by the governing body to be the food service director was full-time and qualified in accordance to State law (refer to A023, A618); 2. ensure patients were protected while investigating an allegation of abuse at the hospital (refer to A118, A115); 3. implement a process for prompt resolution of patient grievances (refer to A145, A115); 4. ensure orders for the use of restraints were not written on an as needed basis (refer to A169, A115); 5. ensure the hospital condition of participation for quality assessment and performance improvement program was met (refer to A263); 6. measure, analyze, and track quality indicators that affected processes of care in regard to the hospital's food and nutrition services (refer to A267); 7. ensure data for temperature and humidity was obtained in areas where invasive procedures were being performed. The facility had no policy to monitor temperature and humidity levels in three Gastrointestinal laboratory procedures rooms and three cardiac catheterization lab procedure rooms, as surgical and invasive procedure settings (refer to A275, A951, A940); 8. ensure review of the flash sterilization log identified the need for additional surgical instruments to ensure the facility had enough instruments so all instruments could undergo the required steam sterilization process. Two specialty trays were flashed sterilized on a routine basis as instruments were not available in sufficient quantities to make up additional trays (refer to A276, A940, A951); 9. ensure three of three Registered Nurses (RN 50, RN 207, and RN 208) demonstrated competence in (1) providing sedation and (2) monitoring patients who received sedation, prior to being assigned to do so (refer to A397); 10. ensure all orders were properly authenticated with the time and date of the physician's signature(refer to A454, A457); 11. ensure all medical records included a time and date to determine which events or entries in other sections of the chart were before or after the untimed entries( refer to A450); 12. ensure supervision of non-employee dialysis nurses who provided services to the patients in the hospital (refer to A398); 13. ensure the hospital condition of participation for pharmacy was met (refer to A490); 14. Ensure patient safety by failing to control and distribute medications to prevent potentially serious medication related errors due to accidental overdose by storing injectable vials of heparin (100 units per ml and 10 units per ml) next to each other in the Neonatal Intensive Care Unit (refer to A500, A490); 15. ensure intravenous medication compounding areas met the requirement to be compliant according to the United States Pharmacopeia 797 standards as stated in the facility's policy and procedures (refer to A500, A490); 16. ensure scheduled II-V drugs were logged and accounted according to the facility's policy and procedures (refer to A500, A490); 17. ensure medications brought in by the patients were inspected and verified by the pharmacist or the physician before use by the patients in the facility according to the state law (refer to A500, A490); 18. ensure contents in Pediatric Crash Carts matched the committee approved list of medications to be included in the Cart (A500, A490); 19. ensure medications were administered in accordance with the manufacturer's recommendation (refer to A500, A490); 20. ensure stored expired scheduled II-V drugs were locked in a secure area to prevent access by unauthorized personnel in the Pharmacy (refer to A503, A490); 21. ensure expired and unusable medications were removed from the patient care area and not available for patient use (refer to A505, A490); 22. ensure the hospital condition of participation for food and dietetic services was met (refer to A618); 23. ensure the daily management of dietary services to provide patients with safe high quality food due to a lack of monitoring of cool down of potentially hazardous foods. (refer to A620, A749, A622, A267, A618); 24. ensure equipment in the kitchen was maintained in good condition to ensure a safe and sanitary environment. (refer to A620, A724, A749, A618); 25. develop a system that integrated the food and dietetic services into the hospital-wide QAPI (quality assurance program improvement) and Infection Control programs. (refer to A267, A749, A620, A622, A724, A629, A630, A618); 26. ensure the hospital's condition of participation for infection control was met (refer to A747); 27. ensure that the hospital's infection control officer had a system to identify deficient infection control practices relating to; a. instrument sterilization in one of nine operating rooms. Facility staff were using a quick sterilization method (flash) for instruments used by two physicians, resulting in the potential for use of improperly sterilized instruments and the spread of infectious diseases during surgical procedures (refer to A747, A749, A940, A951); b. temperature and humidity monitoring in the gastrointestinal and Cardiac Catheterization settings (refer to A747, A749, A940, A951); c. the policy and procedure for Operating Room attire, as facility staff were observed entering restrictive area of the operating room wearing personal/home laundered clothing and hair covers (refer to A747, A749, A940, A951); d. cleaning of reusable patient equipment. One Sterile Processing Technician was observed not following manufacturer's instructions for contact time (refer to A747, A749, A940, A951); e. handling and processing of sterile equipment as the Policy and Procedure was unavailable for sterile instrument presoak and washing and one Sterile Processing Technician was unaware of the correct concentration of wash or the type of wash used for prewashing sterile instruments (refer to A747, A749, A940, A951); 28. ensure proper storage of expired invasive equipment in the cardiac catheterization laboratory. Three guide wires were found stored in the cardiac catheterization storage cabinet and available for use, resulting in the potential to spread infections during cardiac catheterizations (refer to A747, A749, A940, A951); 29. ensure on going integration of an infection control program involving food service and sanitation to ensure food safety and sanitation of food service operations (refer to A747, A749, A618, A620, A630); 30. ensure the air vents were kept clean and free fom dust and debris, resulting in dust and debris particles falling on top of patients during a test of the fire alarm system in the emergency room (refer to A747, A749, A940, A951); 31. ensure the hospital's condition of participation for surgical services was met (refer to A747, A749, A940, A951); 32.ensure the facility provided safe surgical services in accordance with acceptable standards of practice as evidenced by: a. failure to enforce policies and procedures for sterilization of surgical instruments. (Refer to A951, A940); b. failure to monitor temperature and humidity in all areas used for surgical or invasive procedures. (Refer to A951, A940); c. failure to implement their policy and procedure for surgical attire. (Refer to A951, A940). The cumulative effects of these systemic problems and deficient practices resulted in failure to ensure hospital services were delivering care in the safest and most effective manner.

Violation Name: PATIENT RIGHTS(A-0115)

• Inspection Date: 2011-04-27 (Event ID: TWDS11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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21898 Based on observations, staff interview and document review, the hospital condition of participation for patient rights was not met as evidenced by: 1. the facility failed to ensure patients were protected while investigating an allegation of abuse at the hospital (refer to A118); 2. the facility failed to implement a process for prompt resolution of patient grievances (refer to A145); and, 3. the hospital failed to ensure orders for the use of restraints were not written on an as needed basis (refer to A169). The cumulative effects of these systemic problems resulted in failure to ensure care was provided in a manner that protected the rights of each patient.

Violation Name: PATIENT RIGHTS: GRIEVANCES(A-0118)

• Inspection Date: 2011-04-27 (Event ID: TWDS11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** 21898 Based on interview and record review, the facility failed to implement a process for prompt resolution of patient grievances for three patients (Patient 100, 313, and 309). Findings: An interview was conducted with the DRM on April 20, 2011, starting at 9:15 a.m. The DRM stated a complaint was defined as any issue in-house that could be resolved and addressed right away. If the complaint could not be resolved while the patient was in the hospital, then it would become a grievance. The grievance procedure would require additional steps and written response to the person who initiated the grievance. The DRM further stated any complaint made in writing, or that could not be addressed while the patient was in the hospital, would be classified as a grievance. The facility's policy and procedure titled, Patient Complaints Grievances, with February 2010 as approval date by the Board of Directors, was reviewed. The policy and procedure did not establish a clearly explained procedure for the submission of a patient's written or verbal grievance to the hospital. The definitions of grievance and complaint did not match CMS's definitions. The policy did not follow CMS guidelines for time frames for review and provision of a response for the grievance. The policy did not include that all verbal or written complaints regarding abuse, neglect, patient harm, or hospital compliance with CMS requirements are considered grievances. In a concurrent interview with the DRM on April 21, 2011, at 10 a.m., the DRM acknowledge their current policy and procedure needed to be updated to include the missing elements and revised to include a more clearly explained procedure to be followed for the submission and investigation of a patient's written or verbal grievance to the hospital. The DRM was unable to voice how she incorporated the data collected regarding patient grievances, as well as other complaints that are not defined as grievances, into the hospital's QAPI Program. The DRM stated she only tracked grievances and did not keep a log of complaints. Three cases were discussed with the DRM: 1. The first case involved a female patient (Patient 100) in the ED. The female patient reported inappropriate behavior by a staff member. The patient stated the staff member identified himself as a doctor and grabbed her buttocks while she was lying in bed. The staff member was later identified by the facility as a registry CNA. The DRM stated she became aware of the complainant's allegation on February 23, 2011, and stated she was unable to speak to Patient 100 prior to the patient being discharged from the hospital The DRM stated she decided she would classify Patient 100's allegation as a complaint that did not require any further follow up because she felt Patient 100 was satisfied with how things had been handled prior to the patient leaving the hospital. The DRM stated she came to her conclusion because when she spoke to Patient 100 over the phone, the patient did not tell her about the incident. The DRM stated Patient 100 told her, She was very happy and rated their care as excellent. The DRM stated she did not directly ask Patient 100 about the incident where she had been grabbed by the male staff. When the DRM was asked why she did not ask Patient 100 about the incident, the DRM stated she was afraid she would mis-lead the patient into making the complaint. The DRM stated she should have asked the patient directly about the incident and been more clear and specific about the reason for her phone call to Patient 100. The facility failed to ensure all steps were taken on behalf of the patient to thoroughly investigate the patient's concern. The facility failed to provide written notice of the hospital's resolution to the patient for the incident that took place on February 21, 2011. 2. The second case involved a male patient on the 6th floor, involving an allegation of staff to patient abuse. Patient 313 reported to the facility that a CNA was abusive and pushed his face into the bed rail. The DRM stated she also considered this incident a complaint that did not require any further follow up. The DRM stated she considered the incident a complaint based on the history of the patient's agitated and confused condition, therefore she did not follow the hospital's grievance policy for this case. The DRM stated she did not feel that the allegation of abuse itself was sufficient to make this patient complaint a grievance. 22764 3. The record for Patient 309 was reviewed on April 20, 2011. Patient 309, a [AGE] year old female, presented to the ED on April 2, 2011, at 3:45 a.m., after being involved in a motor vehicle accident. The patient was treated and released at 7:53 a.m. Patient 309 returned to the ED on April 2, 2011, at 1:25 p.m., complaining of a headache and vomiting. During the second visit, Patient 309 told the treating PA she was sexually assaulted by a staff member during her first visit. During an interview with the DRM on April 21, 2011, at 10 a.m., the DRM stated she was in frequent contact with Patient 309, as she was attempting to get the detective's name who was assigned to the case, and a police report. She stated even though she was still involved in investigating the incident, she considered this a complaint from the patient, not a grievance. The DRM stated she did not feel that the allegation of sexual assault itself was sufficient to make this patient complaint a grievance.

Violation Name: PATIENT RIGHTS: FREE FROM ABUSE/HARASSMENT(A-0145)

• Inspection Date: 2011-04-27 (Event ID: TWDS11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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22764 Based on interview and record review, the facility failed to ensure patients were protected while investigating an allegation of abuse for one of two patients who reported abuse by facility staff (Patient 313). This failed practice resulted in the potential for patient harm or death. Findings: During an interview with the DRM on April 19, 2011, at 1:20 p.m., the DRM stated Patient 313 reported on Saturday, April 16, 2011, a CNA had pushed his face into the side rail of his bed. She stated the CNA was allowed to continue working the remainder of the shift, and his following scheduled shifts. She stated he was working on Monday, April 18, 2011, when she began her investigation. The facility policy titled, Abuse Assessment and Reporting, was reviewed on April 19, 2011. The policy included definitions of abuse and neglect, and directions for the staff to identify, investigate, and report abuse of patients who they suspected were abused prior to coming to the facility. The policy did not include information on patient allegations of abuse by staff at the facility. The policy did not include procedures to ensure patients were protected while investigating an allegation of staff to patient abuse.

Violation Name: QAPI(A-0263)

• Inspection Date: 2011-04-27 (Event ID: TWDS11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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21898 Based on observation, interview, and record review, the hospital failed to develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program as evidenced by: 1. the facility failed to measure, analyze, and track quality indicators that affected processes of care in regard to the hospital's food and nutrition services (refer to A267); 2. the facility failed to ensure data for temperature and humidity was obtained in areas where invasive procedures were being performed. The facility had no policy to monitor temperature and humidity levels in three GI laboratory procedure rooms and three cardiac catheterization lab procedure rooms, (AORN), as surgical and invasive procedure settings (refer to A275); 3. the facility failed to ensure review of the flash sterilization log identified the need for additional surgical instruments to ensure the facility had enough instruments so all instruments could undergo the required steam sterilization process. Two specialty trays were flashed sterilized (quicker sterilization process using a hotter temperature for a shorter period of time than regular sterilization) on a routine basis as instruments were not available in sufficient quantities to make up additional trays (refer to A276). The cumulative effects of these systemic problems resulted in failure to ensure hospital services were delivering care in the safest and most effective manner.

Violation Name: DATA COLLECTION & ANALYSIS(A-0273)

• Inspection Date: 2011-04-27 (Event ID: TWDS11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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27157 Based on observation, interview and record review, the hospital failed to measure, analyze, and track quality indicators that affected processes of care in regard to the hospital's food and nutrition services. Findings: 1. On April 25, 2011, the Executive Chef was unable to state correct cooling down procedures in accordance with the directions on the dietarys cooling log. Further, he stated four cooks had not documented roast beef on the cooling log for the period of April 13 - April 23, 2011 to ensure the food was safe to serve to patients. A review of the HACCP COOLING AND REHEATING CHART TIME/TEMPERATURE LOG FOR POTENTIALLY HAZARDOUS FOODS, from March 2, 2011 - April 6, 2011, indicated that roast beef was greater than 70 degrees F after the initial 2 hour cool down time for 14 of 17 (82%) logged entries. According to the instructions that were located on the HACCP COOLING AND REHEATING CHART TIME/TEMPERATURE LOG FOR POTENTIALLY HAZARDOUS FOODS, Critical Control Points: Food is cooled quickly and safely from 140 degrees F to 70 degrees F within 2 hours and then to 40 degrees F or below within an additional 4 hours (total cooling time 6 hours). On April 26, 2011 at 2:30 p.m., the QI Director responsible for oversight of the QAPI within the hospital stated, The focus of quality improvement activities have been on clinical aspects. There currently is zero criteria on food service operations. The QI Director stated the quality assurance department currently did not have any quality improvement indicators for the food service department. The QI Director acknowledged the food service operation utilizes a method of pre-day cooking that was high risk, high volume and potentially problem prone, and should have been a quality indicator that should have been involved in surveillance, monitoring, analyzing and evaluated for improvement to ensure food safety. 2. On April 27, 2011 at 11:45 a.m., LN 8 reviewed Patient 9's clinical record and verified a nurse provided tube feeding of Jevity 1.2 at 20 cc hr on April 8, 2011 while gradually increasing the rate to Jevity 1.2 at 75 cc/hr on April 9, 2011. LN 8 stated a RD left a yellow note to the physician communicating a recommendation to the physician to start a tube-feeding of Jevity 1.2 at 20 cc/hr to an eventual goal rate of 75 cc/hr. LN 8 stated the nurse infused the tube feeding as recommended by the RD, without obtaining a specific physician's order. LN 8 stated, Some of my nurse's treat it [the RD's yellow communication note to the physician] as an order and they need some in-servicing on that. On April 27, 2011 at 1:09 p.m., Patient 5's record was reviewed by the Clinical Nutrition Manager and LN 10. The Clinical Nutrition Manager and LN 10 verified there was not a physical MD order in the clinical medical record despite a nurse entering a diet order for 1800 calorie ADA diet on April 11, 2011 and diet order of mechanical soft chopped on April 12, 2011 into the electronic medical record. The QI Director and LN 10 verified the physicians do not write their orders directly into the electronic medical record, and there should have been a manually written physician's diet order in the clinical record to correspond with the diet orders entered by the nurse into the electronic medical record system. On April 27, 2010 at 2:30 p.m., the Clinical Nutrition Manager stated it was her expectation for the clinical RDs to verify the physician's order from the paper clinical record to the order that the dietary was providing to patient at each time the RD was completing a nutrition assessment or follow-up visit for a patient. The Clinical Nutrition Manager stated the clinical RD's had been completing Diet Order Audits since May of 2010 due to the discrepancies between diet order's received by the dietary department via the electronic medical record versus what the physician ordered, or lack of a physician order, in the paper clinical record. The Clinical Nutrition Manager stated the Diet Order Audits were internal audits to the dietary department only. The Clinical Nutrition Manager stated that she had not analyzed the reports to ensure quality improvement. According to the hospital's policy and procedure entitled NUTRITION CARE DOCUMENTATION IN THE MEDICAL RECORD, DIET ORDER CONFIRMATION; The physician is responsible for providing a written diet order for all patients (includes NPO order.) The hospital lacked a comprehensive system for interdepartmental communication in order to measure, analyze, and track quality indicators that assess processes of care, hospital services and the food and nutrition services operations.

Violation Name: DATA COLLECTION & ANALYSIS(A-0273)

• Inspection Date: 2011-04-27 (Event ID: TWDS11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** 18918 Based on observation, interview, and record review, the facility failed to ensure data for temperature and humidity was obtained in areas where invasive procedures were being performed. The facility had no policy to monitor temperature and humidity levels in three GI laboratory procedure rooms and three cardiac catheterization lab procedure rooms, (areas identified by AORN), as surgical and invasive procedure settings. This failed practice resulted in the potential for procedures being performed in an unsafe manner due to the increased risk for infections and fire. Findings: On April 19, 2011, at 1:45 p.m., a tour of the GI lab was conducted with the manager. The area consisted of three procedure rooms, a decontamination room, pre procedure and post procedure beds and a nursing station. The manager stated they performed about 20 procedures daily. During a tour of procedure room [ROOM NUMBER] there was a cabinet for storage of endoscopes (an instrument used to examine the interior of a hollow organ or cavity of the body, for example the colon or the esophagus). The cabinet was enclosed and vented to allow for drying of the endoscopes after processing. There was a thermostat on the wall that indicated the room temperature was 70? Fahrenheit. In an interview with the manager, on April 19, 2011, at 2 p.m., the manager stated they were not monitoring humidity at this time, just temperatures. On April 20, 2011, at 9:15 a.m., during an interview with the manager of the GI lab, the manager stated while there was a thermostat on the wall, unit personnel did not monitor room temperatures. The manager also stated there was no way of monitoring room humidity. The manager stated patients undergoing procedures were given oxygen during the procedure and a cautery device was occasionally used. Record review for Patient 208 was conducted on April 19, 2011. Patient 208 underwent a colonoscopy (examination of the colon and part of the small bowel with a flexible tube passed through the rectum). Patient 208 underwent this procedure under moderate sedation (conscious sedation- administering sedatives or dissociative agents with or without analgesics to induce a state that allows the patient to tolerate unpleasant procedures while maintaining cardiorespiratory function). In an interview with the VP of Quality on April 20, 2011, at 9:30 a.m., the VP stated she was unaware additional areas of the hospital required temperature and humidity monitoring. On April 21, 2011, at 12:30 p.m., an interview was conducted in the cardiac catheterization lab with the Catherization Lab Coordinator and RN 209. RN 209 stated they were not monitoring temperature and humidity levels in the cath lab procedure rooms. During an interview with the VP of Quality on April 21, 2011, at 12:45 p.m., the VP stated monitoring of temperatures and humidity was not being done in the cath lab. On April 21, 2011, the temperature and humidity logs were reviewed. There was no documentation in the log books that indicated temperature and humidity of the GI procedure rooms and cardiac catheterization rooms was monitored. The facility policy and procedure titled Temperature and Humidity Control in Operating Suites, with a last revision date of July 2010, was reviewed on April 21, 2011. The policy and procedure indicated Operating suites were defined as operating room and labor and delivery areas. The policy did not specify any additional procedural areas as requiring daily monitoring. The document listed as a reference AORN (2009) Perioperative Standards and Recommended Practices including Safe Environment of Care. According to the AORN 2009 Perioperative Standards and Recommended Practices: The Mission was to promote safety and optimal outcomes for patients undergoing operative and other invasive procedures. In the section for Recommended Practices for Safe Environment of Care, AORN indicated the practice guidelines were adaptable to various practice settings including traditional operating rooms, cardiac catheterization laboratories, endoscopy suites, and all other areas where surgery could be performed. Recommendation V indicated: Relative humidity should be maintained between 30 % and 60 % within perioperative suite, including operating rooms, recovery area, cardiac catheterization rooms, endoscopy rooms, instrument processing areas Low humidity increases the risk for fire hazards, while high humidity increases the risk of microbial growth in areas where sterile supplies are stored or procedures are performed. Recommendations indicated temperature and humidity should be monitored and recorded daily

Violation Name: QUALITY IMPROVEMENT ACTIVITIES(A-0283)

• Inspection Date: 2011-04-27 (Event ID: TWDS11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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18918 Based on interview and record review, the facility failed to ensure review of the flash sterilization log identified the need for additional surgical instruments to ensure the facility had enough instruments so all instruments could undergo the required steam sterilization process. Two specialty trays were flashed sterilized (quicker sterilization process using a hotter temperature for a shorter period of time than regular sterilization) on a routine basis as instruments were not available in sufficient quantities to make up additional trays. This failure had the potential to increase risk of post operative infection in patients undergoing these procedures. Findings: On April 18, 2011, at 2 p.m., a tour of the Operating Room was conducted. The restrictive area of the department was identified with a red stripe on the floor. There were nine operating rooms and six flash sterilizers. According to the AORN 2009 Perioperative Standards and Recommended Practices: Use of flash sterilization should be kept to a minimum and flash sterilization should be used only in selected clinical situations and in a controlled manner). Each flash sterilizer had a log with documentation of run cycles nearby. The flash sterilization log for sterilizer six was reviewed on April 18, 2011. There was documentation that a special spinal tray was flash sterilized due to not enough trays/singles. On April 20, 2011, at 2 p.m., OR RN 1 was interviewed. OR RN 1 stated two specialty trays used by two different surgeons were not sent to the Sterile Processing Department for sterilization. According to the RN, the trays contained instruments that were not available in sufficient quantities to make up more than one tray for each surgeon. OR RN 1 stated these trays were sent to SPD for decontamination and cleaning then flash sterilized in the OR prior to surgery. OR RN 1 stated she had been flash sterilizing these specialty trays for six years. In an interview with the SPD Manager on April 20, 2011, at 2:15 p.m., the manager stated to ensure proper sterilization of instruments, the items in a tray should be undergoing soaking, cleaning and sterilization after each use. The SPD manager stated the two specialty trays were not being sent to SPD for sterilization. The sterilization logs and flash control strips for sterilizer six were reviewed on April 20, 2011. Specialty trays identified as either Dr. X tray, or Dr. XX tray, were documented as being flash sterilized on the following dates: February 7, 2011, at 5:46 a.m.; February 8, 2011, at 5:24 a.m., and 10:48 a.m.; February 9, 2011, at 5:05 a.m.; February 10, 2011, at 5:43 a.m., 12:03 a.m., and 2:29 p.m.; February 11, 2011, at 5:59 a.m.; February 15, 2011, at 6:12 a.m., 10:48 a.m., and 11:58 a.m.; February 17, 2011 at 5:27 a.m.; February 18, 2011, at 5:54 a.m., and 7:42 a.m.; February 22, 2011, at 5:13 a.m., and 10:42 a.m.; February 24, 2011, at 5:30 a.m., and 9:52 a.m.; March 1, 2011, at 6:02 a.m.; March 3, 2011, at 5:37 a.m., 11:17 a.m., and 3:05 p.m.; March 7, 2011, at 6:11 a.m.; March 8, 2011, at 5:52 a.m., and 1:14 p.m.; March 10, 2011, at 6:09 a.m., and 10:41 a.m.; March 14, 2011, at 5:03 a.m.; March 17, 2011, at 6:23 a.m.; March 18, 2011, at 6:13 a.m., and 10:30 a.m.; March 22, 2011, at 5:28 a.m.; March 23, 2011, 8:24 a.m.; March 24, 2011, at 5:31 a.m., 9:02 a.m., and 10:37 a.m.; March 28, 2011, at 10:24 a.m.; March 29, 2011, at 12:44 p.m., and; March 30, 2011, at 5:46 a.m. Each of these entries on the sterilizer log indicated not enough trays/singles, as the reason for the flash sterilization. In an interview with the SPD Manager on April 20, 2011, at 2:30 p.m., the manager stated she had identified the overuse of flash sterilization and notified the OR Director in 2010. The SPD manager stated she documented the number of times per day a flash sterilizer was used and the information was sent to the OR Director and Infection Control. The Sterile Processing Biological Monitoring Report, form for February 2011, was reviewed with the SPD manager. The manager stated in addition to this report another report titled OR FLASHING Total Processed Items and DME (Durable Medical Equipment) Statistics, was presented for review. On April 20, 2011, at 4 p.m., the VP of Quality, Patient Safety and Risk Management was interviewed. The VP stated the specialty trays should be cleaned and sterilized in SPD and she was unaware it was not being done. The Chief of the Medical Staff was interviewed by phone on April 20, 2011, at 4:15 p.m. He was unaware of the special spinal trays for the two spine physicians undergoing repeated flash sterilizations without full sterile processing. The facility's policy and procedure titled Sterilization-Steam Using Unwrapped Method (Flash Sterilization) with a last revised date of August 2009 was reviewed on April 20, 2011. The policy indicated flash sterilization would only be used when was insufficient time to process by the preferred wrapped or container method. According to the policy flash sterilization would not be used as a substitute for insufficient instrument inventory. The policy and procedure indicated references used included AORN (2009) Standards and Recommended Practices. The facility's policy and procedure titled Steam Sterilization, with a revision date of August 2009, was reviewed on April 20, 2011. The policy indicated the creation and maintenance of aseptic environments had a direct influence on patient outcomes. The policy indicated measures for preventing surgical wound infections included Provision of instrumentation, supplies, and equipment free of contamination at the time of use. Sterilization provides the highest level of assurance that an object is free of viable microbes. According to the policy, steam sterilization was a process that utilized saturated steam under pressure, for a specific exposure time and at a specified temperature, as a sterilizing agent. Items to be sterilized are those that enter sterile tissue or the vascular system. Minutes from the Treatment and Surveillance Committee were reviewed on April 20, 2011. There was no documentation/evidence in the report that indicated flash sterilization in the OR was being reviewed. The Sterile Processing Biological Monitoring Report, forms for January 2010 through March 2011 were reviewed on April 20, 2011. The form indicated the report would be sent to Infection Control no later than the tenth of every month. The form contained areas to document Total # of loads ran, # Biological ran, # of Positive Biologicals, and Days out of service. for the two steam sterilizers, and two plasma sterilizers. The form instructed that all steam and plasma autoclaves would have a biological test run once per day. For the six flash sterilizers, the form indicated instead of loads ran, # of days ran, was to be documented. From January through June 2010 the following numbers were documented in the section to record # of days ran for sterilizer six: January-67; February-77; March-86; April -77; May-81; June-102; (These numbers more closely resemble number of loads run as opposed to number of days ran.) The reports for September 2010 through February 2011, indicated the number of loads ran were similar to the number of biologicals ran. According to the report, sterilizer six was run 31 days in January 2011 and 31 biological tests were completed. There was no indication of the number of flash sterilizations processed in sterilizer six for January 2011. In February 2011, there were 28 biological tests run in sterilizer six and the unit was run 28 days. There was no indication of the number of flash sterilizations processed in sterilizer six for February 2011. The Sterile Processing Biological Monitoring Report, form for February 2011 was reviewed on April 20, 2011. The form indicated 85 loads were processed in sterilizer six in February 2011, with 9 loads processed on February 10, 2011.

Violation Name: PATIENT SAFETY(A-0286)

• Inspection Date: 2011-04-27 (Event ID: TWDS11)
• Facility Name: RIVERSIDE COMMUNITY HOSPITAL

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27157 Based on observation, interview and record review, the hospital failed to measure, analyze, and track quality indicators that affected processes of care in regard to the hospital's food and nutrition services. Findings: 1. On April 25, 2011, the Executive Chef was unable to state correct cooling down procedures in accordance with the directions on the dietarys cooling log. Further, he stated four cooks had not documented roast beef on the cooling log for the period of April 13 - April 23, 2011 to ensure the food was safe to serve to patients. A review of the HACCP COOLING AND REHEATING CHART TIME/TEMPERATURE LOG FOR POTENTIALLY HAZARDOUS FOODS, from March 2, 2011 - April 6, 2011, indicated that roast beef was greater than 70 degrees F after the initial 2 hour cool down time for 14 of 17 (82%) logged entries. According to the instructions that were located on the HACCP COOLING AND REHEATING CHART TIME/TEMPERATURE LOG FOR POTENTIALLY HAZARDOUS FOODS, Critical Control Points: Food is cooled quickly and safely from 140 degrees F to 70 degrees F within 2 hours and then to 40 degrees F or below within an additional 4 hours (total cooling time 6 hours). On April 26, 2011 at 2:30 p.m., the QI Director responsible for oversight of the QAPI within the hospital stated, The focus of quality improvement activities have been on clinical aspects. There currently is zero criteria on food service operations. The QI Director stated the quality assurance department currently did not have any quality improvement indicators for the food service department. The QI Director acknowledged the food service operation utilizes a method of pre-day cooking that was high risk, high volume and potentially problem prone, and should have been a quality indicator that should have been involved in surveillance, monitoring, analyzing and evaluated for improvement to ensure food safety. 2. On April 27, 2011 at 11:45 a.m., LN 8 reviewed Patient 9's clinical record and verified a nurse provided tube feeding of Jevity 1.2 at 20 cc hr on April 8, 2011 while gradually increasing the rate to Jevity 1.2 at 75 cc/hr on April 9, 2011. LN 8 stated a RD left a yellow note to the physician communicating a recommendation to the physician to start a tube-feeding of Jevity 1.2 at 20 cc/hr to an eventual goal rate of 75 cc/hr. LN 8 stated the nurse infused the tube feeding as recommended by the RD, without obtaining a specific physician's order. LN 8 stated, Some of my nurse's treat it [the RD's yellow communication note to the physician] as an order and they need some in-servicing on that. On April 27, 2011 at 1:09 p.m., Patient 5's record was reviewed by the Clinical Nutrition Manager and LN 10. The Clinical Nutrition Manager and LN 10 verified there was not a physical MD order in the clinical medical record despite a nurse entering a diet order for 1800 calorie ADA diet on April 11, 2011 and diet order of mechanical soft chopped on April 12, 2011 into the electronic medical record. The QI Director and LN 10 verified the physicians do not write their orders directly into the electronic medical record, and there should have been a manually written physician's diet order in the clinical record to correspond with the diet orders entered by the nurse into the electronic medical record system. On April 27, 2010 at 2:30 p.m., the Clinical Nutrition Manager stated it was her expectation for the clinical RDs to verify the physician's order from the paper clinical record to the order that the dietary was providing to patient at each time the RD was completing a nutrition assessment or follow-up visit for a patient. The Clinical Nutrition Manager stated the clinical RD's had been completing Diet Order Audits since May of 2010 due to the discrepancies between diet order's received by the dietary department via the electronic medical record versus what the physician ordered, or lack of a physician order, in the paper clinical record. The Clinical Nutrition Manager stated the Diet Order Audits were internal audits to the dietary department only. The Clinical Nutrition Manager stated that she had not analyzed the reports to ensure quality improvement. According to the hospital's policy and procedure entitled NUTRITION CARE DOCUMENTATION IN THE MEDICAL RECORD, DIET ORDER CONFIRMATION; The physician is responsible for providing a written diet order for all patients (includes NPO order.) The hospital lacked a comprehensive system for interdepartmental communication in order to measure, analyze, and track quality indicators that assess processes of care, hospital services and the food and nutrition services operations.

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