CMS-Frisbie-Memorial-Hospital

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview and review of the hospital admission package it was determined that the hospital failed to inform patients of the correct Quality Improvement Organization (QIO) information in the hospital and in 11 out of 11 Hospital Physician Practices surveyed.

Findings include:

Review on 3/17/17 of the hospital's admission package policy and procedure form entitled PATIENT RIGHTS AND RESPONSIBILITIES dated 8/16 revealed that the form had the incorrect Quality Improvement Organization (QIO) information on the Patient Rights and Responsibilities form which read as follows :

To question any aspect of your care, and to request a review and seek resolution to any complaint. Complaints regarding the quality of your care may be directed to the appropriate department manager or directly to: Quality Improvement Organization (QIO) [incorrect pronoun and address omitted] [incorrect phone number omitted]

During tour of 11 of the 11 hospitals Physician Practices on 3/17/17, it was confirmed and revealed through interviews with the individual practice managers that the Patient Registration Form is signed by the patients upon initial registration and annually thereafter. The form was last updated 8/16. The Patient Registration Form states that the patient has received the PATIENT RIGHTS AND RESPONSIBILITIES.

During tour of 11 of the 11 Hospitals Physician Practices and including the hospital on [DATE] revealed that the Patient Rights and Responsibilities are posted on the walls in the waiting rooms in all the hospitals Physician Practice's and in the Hospital itself.

It was confirmed by Staff O, (Physician Practice Transform Specialist) that the Patient Rights and Responsibilities are on the walls in the waiting rooms in all the Hospitals Physician Practices and in the Hospital. The incorrect information for the QIO is contained in this document. Individuals filing a complaint would have incorrect information according this posted document.

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Based on interview and observation it was determined that the hospital failed to maintain a hospital wide surveillance program to monitor compliance with all infection control requirements in order to prevent and control a safe sanitary environment to avoid sources and transmission of infections and communicable disease.

Findings include:

During interview on 3/17/17 with Staff L (Infection Prevention Coordinator), Staff H (Senior Director of Quality Improvement) and Staff N (Registered Nurse) revealed that the hospital had no documented evidence of infection control hospital wide environmental surveillance to include all departments located in the hospital (e.g. kitchen, housekeeping, laundry department, maintenance, to include biohazard waste, supply storage) and off site locations (e.g. urgent care).

Cross reference A 726.

Observation on 3/16/17 at 12:40 p.m. during a tour of Caring Partners Obstetrics & Gynecology revealed small tears in the front two corners of the exam table in exam room four.

Interview on 3/16/17 at 12:40 p.m. with Staff A (Practice Manager) and Staff B (Clinical Coordinator), reviewed the above findings and Staff A and Staff B confirmed there were tears in the exam table. Staff B revealed that it was practice to inspect and clean exam tables after patient use and that a repair request for the tears observed on exam room four's exam table had not been performed.

Observation on 3/16/17 at 12:50 p.m. during a tour of Stafford Cardiology Associates revealed small tears in the front two corners of the exam table in exam room one.

During interview on 3/16/17 at 12:50 p.m. with Staff C (Practice Manager), Staff C confirmed there were tears in the exam table. Staff C revealed that it was practice to inspect and clean exam tables after patient use and a repair request for the tears observed in exam room one's exam table had not performed.

Observation on 3/16/17 at 9:30 a.m. in the recovery area of the operating room (OR) revealed a recovery chair in the hallway with two large round holes on the left side and one tear on the front foot rest.

Interview on 3/16/17 at 9:30 a.m. with Staff F (Director Surgical Services) confirmed the above finding and revealed the chair was used for patients during recovery.

Observation in the recovery area of the OR on 3/16/17 at 9:45 a.m. revealed a glucose meter with a blue substance consistent with control solution on front and back of the meter at the nursing station on the docking station. There was also a small dried red/brown substance on the back of the meter.

Interview on 3/16/17 at 9:45 a.m. with Staff I (OR, Registered Nurse) confirmed the above findings and revealed it is the policy of the hospital to clean the glucose meter after each use. Interview also revealed that the glucose meter on the docking station would be ready for use.

Observation during tour of the OB (Obstetrical) surgical suite on 3/16/17 at approximately 11:40 a.m. revealed that some of the horizontal surfaces contained a heavy build up of dust.

Interview on 3/16/17 at approximately 11:41 a.m. with Staff F (RN) confirmed that there was a build up of dust on some of the horizontal surfaces.

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**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation and interview the hospital failed to secure drugs and biologicals to prevent access by unauthorized individuals in Surgical Services, Emergency Services, Obstetrics, Pharmacy, Endosocopy Unit and 2 off site satellite offices, failed to sufficiently lock areas to allow access by only authorized personnel and failed to remove expired medications from 1 off site location.

Findings include:

Observation on tour of the surgical suite on 3/26/13 at 1:30 p.m. revealed anesthesia carts in the 4 operating rooms in surgical services and the operating room on Obstetrics were unlocked. The drawers of the anesthesia carts contained multiple medications, and also contained needles and syringes. All the anesthesia carts have a metal box affixed to the outside. The metal box is referred to as the locked box by Staff G, (Director of Surgical Services). Observation revealed Succinylcholine and Propofol are stored in the locked box which was found to be unlocked on 4 of 5 anesthesia carts.

Interview on 3/26/13 at 2:30 p.m. with Staff G, (Director of Surgical Services), confirmed the anesthesia carts in the 4 operating rooms in surgical services and the operating room in Obstetrics were unlocked. Staff G confirmed the locked box affixed to each anesthesia cart was unlocked on 4 of the 5 anesthesia carts. Staff G also confirmed unauthorized personnel does have unmonitored access to the surgical area and the anesthesia carts.

Observation on tour of the Endoscopy unit on 3/27/13 at 2:00 p.m. revealed an unlocked refrigerator in Storage Room B with Succinylcholine stored in it. The storage room is accessible to personnel who are not authorized to have access to medication.

Interview with Staff H, (Registered Nurse Endoscopy Team Leader), on 3/27/13 at 2:30 p.m. confirmed the refrigerator in Storage Room B is unlocked, contains the medication Succinylcholine and the room is accessible to personnel who are not authorized to have access to medication.

Observation during tour of Pharmacy on 3/28/13 at 10 a.m. with Staff K, (Director of Pharmacy), revealed the delivery door of the pharmacy did not fully latch. Surveyor in the presence of Staff K, demonstrated direct access through the delivery door without the use of a key or staff assistance. Once through the delivery door of the pharmacy, there is access to all medications in the pharmacy with the exception of controlled substances. The delivery door would fully latch if pulled shut; however, not if left to close by door closer.

During tour of the rehab offsite unit on 3/28/13 it was observed that in the medication cabinet the bottle of dexamethasone (Anti-inflammatory) that was for in-patient use had expired on ,d+[DATE]. Observation of the remaining boxes of the medication in the cabinet also had the expiration date of 10/12. Interview at time of tour with Staff P, (Director of Rehab) confirmed the above findings.

Cross reference to A0502 and A0504

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**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, and staff interview it was determined that the hospital failed to secure drugs and biologicals to prevent unmonitored access by unauthorized individuals.

Findings include:

Observation in the Oncology department on 3/27/13 at approximately 11:00 a.m. revealed that the intake room for oncology patients had an unsecured sharps container positioned freely in a wall mounted cabinet counter top holder which contained contaminated needles, syringes and used medication vials.

During interview with Staff C (Registered Nurse) at the time of the above listed observation Staff C confirmed that the free standing sharps container with contaminated needles, syringes and used medication vials was unsecured on top of the intake room counter top which can be accessed by unauthorized individuals when the room is unoccupied or staff is busy.

Observation in the emergency room on [DATE] with Staff E (Registered Nurse) at approximately 9:30 a.m. showed an unsecured mobile rapid sequence intubation (RSI) cart located in a emergency room hallway. The drawers in this cart could be opened freely. Observation of the top drawer of this cart revealed the following medications, 2% Lidocaine Viscous Oral Solution, 2% vial of Lidocaine injectable, 0.9% Sodium Chloride injectable and NeoSynephrine 0.5% spray bottle which could be accessed by unauthorized individuals.

During the tour of 1 of the 6 Specialty Practices visited on 3/26/13 at 3:30 p.m. with Staff L, (Practice Manager) it was observed that a refrigerator was unlocked and had several different type of vials of insulin inside. The refrigerator has no way to be locked and is located in an unlocked room.

Interview during tour with Staff L and Staff F, (Vice President, Physician Practice Services), indicated that housekeeping from the hospital comes in after hours to clean the area when no one from the Specialty Practice staff is present.

Observation on tour of the surgical suite on 3/26/13 at 1:30 p.m. revealed anesthesia carts in the 4 operating rooms in surgical services and the operating room on Obstetrics were unlocked. The drawers of the anesthesia carts contained multiple medications, and also contained needles and syringes. All the anesthesia carts have a metal box affixed to the outside. The metal box is referred to as the locked box by Staff G, (Director of Surgical Services). Observation revealed Succinylcholine and Propofol are stored in the locked box which was found to be unlocked on 4 of 5 anesthesia carts.

Interview on 3/26/13 at 2:30 p.m. with Staff G, (Director of Surgical Services), confirmed the anesthesia carts in the 4 operating rooms in surgical services and the operating room in Obstetrics were unlocked. Staff G confirmed the locked box affixed to each anesthesia cart wwas unlocked on 4 of the 5 anesthesia carts. Staff G also confirmed unauthorized personnel does have unmonitored access to the surgical area and the anesthesia carts.

Observation on tour of the Endoscopy unit on 3/27/13 at 2:00 p.m. revealed an unlocked refrigerator in Storage Room B with Succinylcholine stored in it. The storage room is accessible to personnel who are not authorized to have access to medication.

Interview with Staff H, (Registered Nurse Endoscopy Team Leader), on 3/27/13 at 2:30 p.m. confirmed the refrigerator in Storage Room B is unlocked, contains the medication Succinylcholine and the room is accessible to personnel who are not authorized to have access to medication.

Observation during tour of Pharmacy on 3/28/13 at 10 a.m. with Staff K, (Director of Pharmacy), revealed the delivery door of the pharmacy did not fully latch. Surveyor in the presence of Staff K, demonstrated direct access through the delivery door without the use of a key or staff assistance. Once through the delivery door of the pharmacy, there is access to all medications in the pharmacy with the exception of controlled substances. The delivery door would fully latch if pulled shut; however, not if left to close by door closer.

During tour of the rehab offsite unit on 3/28/13 it was observed that in the medication cabinet the bottle of dexamethasone (Anti-inflammatory) that was for in-patient use had expired on ,d+[DATE]. Observation of the remaining boxes of the medication in the cabinet also had the expiration date of 10/12. Interview at time of tour with Staff P, (Director of Rehab) confirmed the above findings.

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Based on record review, staff interview, observation and review of the hospital policy and procedure it was determined that the hospital failed to inform emergency room patients and 7 out of 9 physician practices services patients in advance of furnishing services of their rights and responsibilities.

Findings include:

Review of the hospital PATIENT RIGHTS AND RESPONSIBILITIES policy and procedure dated 10/2011 revealed the following:

I. PURPOSE:

This policy is written to communicate to all parties the ... (hospital) philosophy and practice concerning patient rights and responsibilities...

IV. PROCEDURE:

2. All patients will be provided a copy of their Patient Rights prior to or at the time of admission and advised of the hospital's policy on Patient Rights and Responsibilities.

During interview with Staff B (Patient Registration, Emergency Department) on 3/27/13 at approximately 9:45 a.m., Staff B verbalized that when patients present to the emergency room registration desk they are told that the PATIENT RIGHTS AND RESPONSIBILITIES sheets are located on the front counter of the emergency room registration desk or they can read the posted PATIENT RIGHTS AND RESPONSIBILITIES displayed in the emergency room waiting area.

During interview with Staff A (Director of Medical Records) on 3/27/13 at approximately 1:15 p.m., Staff A made a telephone call to the emergency room registration staff and following this conversation, Staff A relayed that patients who present to the emergency room do not sign the patient registration form that states in the section titled PATIENTS RIGHTS AND RESPONSIBILITIES/PATIENT GRIEVANCE PROCEDURE the following:

I acknowledge and understand the policy describing my rights and responsibilities, and the procedures governing my conduct have been explained to me and I have received a printed copy of the Patient Rights and Responsibilities & Patient Grievance Procedure. until they are admitted to the hospital for a length of stay.

The hospital failed to ensure that patients presenting in the emergency room for treatment or services had their patient rights and responsibilities explained to them before treatment.

During tour of 7 of the 9 Physician Practice Services on 3/26/13 and 3/27/13 it was confirmed during interviews by the individual practice managers that the Patient Registration Form is signed by the patients upon initial registration and annually thereafter. The form was last updated 1-8-13. Under the section PATIENTS RIGHTS AND RESPONSIBILITIES/PATIENT GRIEVANCE PROCEDURE which stated the following:

I acknowledge and understand the policy describing my rights and responsibilities, and the procedures governing my conduct have been explained to me and I have received a printed copy of the Patient Rights and Responsibilities & Patient Grievance Procedure. It was also confirmed that the Patient Rights and Responsibilities form is not handed out to the patient at the time of check in, but the Patient Rights and Responsibilities are on the wall in the waiting room if they would like to read them.

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Based on record review, interview and review of the hospital medical records policy and procedure it was determined that the hospital failed to ensure that the medical record entries for 4 of 4 emergency room transfer patients reviewed were complete, dated, timed and signed. (Patient identifiers are #58, #59, #60 and #61.)

Findings include:

Review of the hospital policy and procedure titled MEDICAL RECORD CONTENT AND MAINTENANCE revealed the following:

I. PURPOSE:

This policy addresses the process by which the Medical Records Department verifies that a medical record exists for every individual, both inpatient and outpatient evaluated or treated in the hospital. The term 'medical records' includes at least written documents, computerized electronic information ..., radiology reports, laboratory reports, pathology reports, and other forms of information regarding the condition of a patient. The staff of the Medical Records Department also ensure the records are accurately written, promptly completed, properly filed and retained, and accessible in accordance with the Conditions of Participation of the Centers for Medicare and Medicaid services, applicable state law and hospital policy...

III. RESPONSIBILITY:

C. The medical records department staff shall ensure the medical records are complete and conform to the documentation guidelines set forth in the Rules and Regulations of the Medical Staff, applicable state law, and CMS Conditions of Participation...

Patient #58.

Record review on 3/27/13 of the emergency room record for Patient #58 dated 1/1/13 revealed that the TRANSFER CERTIFICATION form showing that Patient #58 was transferred to another hospital was not completed in the following sections; possible RISKS, PHYSICIAN'S CERTIFICATE OF TRANSFER and not dated in the TRANSFER ACCEPTANCE section.

Patient #59.

Record review on 3/27/13 of the emergency room record for Patient #59 dated 3/26/13 revealed that the TRANSFER CERTIFICATION form showing that Patient #59 was transferred to another hospital was not completed in the section TRANSFER ACCEPTANCE with the Name of Receiving Physician.

Patient #60.

Record review on 3/27/13 of the emergency room record for Patient #60 dated 3/21/12 revealed that the TRANSFER CERTIFICATION form showing that Patient #60 was transferred to another hospital and the PHYSICIAN'S CERTIFICATE OF TRANSFER section were not completed.

Patient #61.

Record review on 3/27/13 of the emergency room record for Patient #61 dated 3/20/13 revealed that the TRANSFER CERTIFICATION form showing that Patient #61 was transferred to another hospital was not completed with the date and time in the PHYSICIAN'S CERTIFICATE OF TRANSFER section and the section for name of Ambulance Service, Attendant's Signature and date were not completed.

During interview with Staff A (Director of Medical Records) on 3/27/13 at approximately 1:15 p.m. after Staff A reviewed the above listed findings, Staff A confirmed that the hospital emergency room transfer forms for Patients #58, #59, #60 and #61 were not complete.

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Based on staff interview, observation and review of infection control information it was determined that the infection control nurse failed to effectively monitor infection control practices to prevent the spread of infections and failed to ensure that the required annual mandatory infection control education was completed for staff personnel.

Findings include:

Review of the Position Description for the Director of Infection Prevention Dated Evaluated: 03/2013 with the next Review Date 03/2013 revealed the following:

Position Objective:

Infection Prevention

Infection Prevention functions in collaboration with the Infectious Disease Physician and Hospital Departments. To provide effective prevention and control practices by conducting active surveillance of prevention and control measures designed to meet the population served and patient continuum of care.

Surveillance activities are directed toward prevention and control practices that apply to hospital practice settings for the population served and reflects an assessment of infection risks at ... (hospital) and our community.

Essential Position Functions:

To conduct annual education programs for health care providers on infection risks as well as their specific roles in the infection control program...

To conduct surveillance activities to review, analyze reports of significant health care associated infections and implement necessary control measures...

To maintain a systematic approach to surveillance in order to monitor the effectiveness of prevention and control strategies...

Volunteer and employee participation in orientation and mandatory annual and ongoing education programs, including Bloodborne pathogens and tuberculosis.

Integration with Employee Health Services regarding the reporting of any suspected or diagnosed infections, exposures to blood or body fluids, health care associated infections, tuberculosis and other communicable diseases...

Infection Prevention and Control Committee:

Approving the surveillance program and providing direction relative to outbreak occurrences...

During interview with Staff M (Infection Control) on 3/27/13 at approximately 9:15 a.m. Staff M confirmed by interview and could show no documented evidence of infection control surveillance monitoring rounds for the hospital clinical areas, ancillary service areas as well as off site campus locations.

Review of the annual mandatory infection control education reports titled Assignment Completion Report with a date range from 10/1/2011 through 3/28/2013 revealed that over 30 staff from in house and off site campus departments had not completed the mandatory education.

During review of the above listed annual education report and interview with Staff S (Vice President Patient Care Services) on 3/28/13, Staff S confirmed that over 30 staff personnel from in house and off site campus departments had not completed the annual mandatory infection control education.

During tour of a Family Practice office on 3/27/13 at 8:00 a.m. with Staff D, (Practice Manager) it was observed that the pad on the exam table in Exam Room #8 had a tear in the corner showing the inside foam.

Interview on 3/27/13 with Staff D and Staff F, (Vice President, Physician Practice Services), confirmed that Staff D and Staff F were unaware of the tear in exam table and Staff F was unaware that it could be an infection control issue when cleaning.

During the tour of a Walk-In Practice on 3/27/13 at approximately 8:30 a.m. with Staff D, it was observed that the pad on the exam table in Exam Room #12 had a tear in the corner showing the inside foam.

Interview on 3/27/13 with Staff D and Staff F confirmed that Staff D and Staff F were unaware of the tear in exam table and that it could be an infection control issue when cleaning.

During tour of the 1 of the 6 Specialty Practices visited on 3/27/13 it was noted that in the triage room under the bench seat the laminated area was chipped and the board underneath was exposed. The board is porous and not cleanable.

Interview with Staff N, (Practice Manager) during tour indicated it was hard to keep the area covered because the patients keep hitting and kicking it and chipping the laminated area.

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Based on observation and interview the facility has failed to maintain an environment in several departments that are safe from public access by using appropriate security mechanisms to be in place to protect patients.

Findings include:

During tour and observation of the hospital during survey from 3/26/13 through 3/28/13 it was found that multiple areas throughout the hospital could be accessed with no security in place. These areas are as follows:

1) The elevator that travels from the emergency room to medical surgical unit called the Spaulding Unit, also has direct access to the operating room. Any person from either area (emergency room or medical surgical unit) could enter the elevator, push the first floor button and end up at the double doors just outside the semi-restricted hallway which is not locked and has direct access to the operating rooms.

2) During tour of the radiology department it was found through observation that three doors have direct access to the department with no security. All three doors are located in the public corridor and have direct access into the radiology department. These three doors were observed and shown to Staff J (Director of Radiology). Staff I (Director of Facilities) was asked to define the doors which are as follows: (Doors 17, 35, 117) all failing to have locking mechanisms on them to prevent public access.

3) During tour of the wounds clinic there's a public access hallway that travels past the endoscopic procedure room where two double doors are located. These doors are unlocked and can be activated by a push pad having direct access into the procedure rooms of the endoscopic suite. The doors were shown to Staff J who defined the doors as the rear corridor entrance to the endoscopic suite.

4) During tour of the maternity unit it was found that there is an operating room utilized for C-Sections as confirmed by Staff G (Director Surgical Services) located within the unit. To enter this area there are two double doors that are unlocked and have direct access to the operating room with no security to prevent access from others.

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Based on tour of multiple surgical areas on 3/26/13 and 3/28/13 it was observed that the facility failed to maintain an environment to meet surgical services. The facility failed to have proper ceiling tiles within the semi-restricted environment areas, and failed to have wall finishes that can be cleanable, along with failing to maintain horizontal surfaces free from dust in operating rooms, along with failing to maintain monolithic flooring in the endoscopy surgical suite.

Findings include:

Ceilings...

AIA, (American Institute of Architecture) Guidelines for Design and Construction of Health Care Facilities 2.1 General Hospitals 8.2 General Standards for Details and Finishes 8.2.3.4 Ceilings...

(3) Semirestricted areas

(a) Ceiling finishes in semirestricted areas such as air borne infection isolation rooms, protective environment rooms, clean corridors, central sterile supply spaces, specialized radiographic rooms, and minor surgical procedure rooms shall be smooth, scrubbable, nonabsorptive, non perforated, capable of withstanding cleaning with chemicals, and without crevices that can harbor mold and bacterial growth.

(b) If lay-in ceiling is provided, it shall be gasketed or clipped down to prevent the passage of particles from the cavity above the ceiling plane into the semirestricted environment. Perforated, tegular, serrated, or highly textured tiles shall not be used.

During tour of the surgical suites it was observed and shown to Staff G (Director of Surgical Services) that all the ceiling tiles located within the semi-restricted corridors and sterile supply spaces were perforated ceiling tiles. These tiles were not scrubbable and capable of withstanding cleaning and/or disinfecting chemicals. Also these tiles failed to be clipped down or gasketed, this was told to Staff G at the time of finding on 3/26/13.

During tour of the maternity unit on 3/26/13 it was observed and shown to Staff G that the semi-restricted corridors had perforated ceiling tiles. These tiles were not scrubbable and capable of withstanding cleaning and/or disinfecting chemicals.

Wall finishes...

2010 Guidelines for Design and Construction of Health Care Facilities 3.7-7 Design and construction Requirements, 3.7-7.2 Architectural Details, Surfaces, and Furnishings. 3.7-7.2.3.3 Walls. Wall finishes shall be appropriate for the areas in which they are located and shall be as follows:

(1) Wall finishes shall be cleanable.

(2) Wall finishes in areas such as clean corridors, central sterile supply spaces, specialized radiographic rooms, and minor surgical procedure rooms shall be washable, smooth, and able to withstand chemical cleaning ...

Operation rooms 1 and 2 were observed with Staff G and both operating rooms failed to maintain wall finishes to withstand chemical cleaning.

During tour of the above areas it was observed with Staff G on 3/26/13 that two different walls had gouges/tears in the Sheetrock. Also the Sheetrock paper was ripped and torn in several areas throughout the surgical suites failing to be washable and capable of withstand chemical cleaning. These areas are as follows:

1) Operating room 1 had a metal access panel around 12 x 12 cut into the Sheetrock wall with exposed wires exiting the bottom of the panel. Staff G thought the wires were for the surgical boom. All the edges around the access panel had exposed Sheetrock and failed to be sealed.

2) Operating room 2 had a computer jack (pp/33-41) that was pulled from the wall exposing the Sheetrock where it had been attached.

Dust in OR's...

AORN(Association of periOperative Registered Nurses) 2009 Edition Page 439. Recommended Practices for Environmental Cleaning in the Perioperative Setting. Recommendation 1 The patient should be provided a clean, safe environment...

1.b All horizontal surfaces in the OR (eg, furniture, surgical lights, booms, equipment) should be damp dusted before the first scheduled surgical procedure of the day. Plasma and monitor screens should be cleaned according to manufacturers' instructions.

Dust is known to contain human skin and hair, fabric fibers, pollens, mold, fungi, insect parts, glove powder, and paper fibers among other things. Airborne particles range in size from 0.001 microns to several hundred microns. Contamination for particles can come from an external source (eg, ventilation, doors) or an internal source...

Facility Policy (Operating Room Sanitation) with an effective date of 8/2006 states Prior to the first scheduled procedure of the day, horizontal surfaces should be damp dusted. Damp dusting should be done with a clean cloth moistened with an appropriate agent...

During tour of the surgical suites on 3/26/13 and tour of the endoscopy suite on 3/27/13 it was observed by surveyor and shown to Staff G and Staff H (Team Leader) that several horizontal surfaces in all 5 operating rooms and 4 endoscopy rooms had dust build up. Staff G observed these findings at the time when surveyor checked the horizontal surfaces. These same findings were found with Staff H during the inspection of the 4 endoscopy procedure rooms.

Flooring...

2010 Guidelines for the Design and Construction of Health Care Facilities 3.9 Specific Requirements for Gastrointestinal Endoscopy Facilities.

3.9-7.2.3.2 Flooring

1) Floor finishes. Floor finishes in the gastrointestinal endoscopy facility shall be appropriate for the areas in which they are located and shall be as follows:

2) Procedure room floors. Floor covering in the procedure suite shall be monolithic and joint free.

During tour of the endoscopy surgical suite on 3/27/13 with Staff G and Staff H it was observed that the floor seams that created a monolithic membrane were split and cracked making open voids in the floor for procedure rooms 1, 2, and 3.

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Based on observation,record review and interview the facility failed to monitor 4 surgical suites for positive pressure by using differential-pressure-indication devices. Also the facility failed to maintain the proper air changes from the original design for the surgical suites, along with maintaining cleaning of air ducts.

Findings include:

Pressure Differentials...

ANSI [American National Standard Institute]/ASHRAE/ASHE [American Society for Healthcare Engineering] Standard 170-2008 Ventilation of Health Care Facilities. Page 11. 7.4 Surgery Rooms. 7.4.1 Class B and C Operating Rooms. Operating rooms shall be maintained at a positive pressure with respect to all adjoining spaces at all times. A pressure differential shall be maintained at a value of at least =0.01 in. wc (2.5Pa).

ASHRAE (American Society of Heating, Refrigerating and Air-Conditioning Engineers) Chapter 7 Health Care Facilities. Specific Design Criteria Surgery and Critical Care. 7.5 The following conditions are recommended for operating, catheterization, cystoscopic, and fracture rooms:

Air pressure should be kept positive with respect to any adjoining rooms by supplying excess air.

A differential-pressure-indication device should be installed to permit air pressure readings in the rooms. Thorough sealing of all wall, ceiling, and floor penetrations, and tight-fitting doors are essential to maintaining readable pressure.

During tour on 3/27/13 of the hospitals surgical suites it was observed that 4 of the 5 operating rooms failed to have differential pressure indication devices on the walls to show that the rooms are in positive pressure to the adjoining spaces. All findings were shown to Staff G (Director of Surgical Services) at time of tour.

Maintain Original Design...

ASHRAE (American Society of Heating, Refrigerating and Air-Conditioning Engineers) Standard 170-2008 Ventilation of Health Care Facilities

Page 11 #8. Planning, construction, and system startup.

8.1 Overview. For HVAC (Heating, Ventilation and Conditioning) systems serving surgery and critical care spaces, compliance with this standard requires preparation of an acceptance testing plan.

8.5 Documentation of New or Remodeled HVAC Systems. Owners shall retain an acceptance testing report for their files. In addition, the design shall include requirements for operations and maintenance staff training that is sufficient for the staff to keep all HVAC equipment in a condition that will maintain the original design intent for ventilation. Training of operating staff shall include an explanation of the design intent. The training materials shall include, at a minimum, the following:

a. O&M procedures

b. Temperature and pressure control operation in all modes

c. Acceptable tolerances for system temperature and pressures

d. Procedures for operations under emergency power or other abnormal conditions that have been considered in the facility design.

During tour of the surgical suites on 3/26/13 it was observed and shown to Staff G (Director of Surgical Services) that the air returns in several of the operating rooms were very poor. A tissue/paper test was performed by holding a tissue/paper in front of the return, where the tissue/paper would be pulled in. When this was done the tissue/paper would not pull in as strong as the opposite return did. This was shown to Staff G who agreed that the returns were not of the same draw/strength.

On review of the facility's airflow report dated 3/22/12, which is the most current air balance report as confirmed by Staff I, (Director of Facilities) it shows that the air returns for each operating room failed to meet the as built design.

Operating rooms returns (each OR has two returns, R1 and R2) should be balanced equally, for proper air movement, or CFM (cubic feet per minute).

Design/as built.

Operating room 1 as built R1- 650 cfm, R2 not specified. tested R1- 277 cfm, R2-328 cfm

Operating room 2 as built R1-500 cfm, R2 -500 cfm. tested R1-106 cfm, R2-139 cfm

Operating room 3 as built R1-500 cfm, R2-500 cfm. tested R1-318 cfm, R2-342 cfm

Operating room 4 as built R1- not specified, R2-700 cfm. tested R1-198 cfm, R2-211 cfm

Operating room 5 as built R1-500 cfm, R2-500 cfm. tested R1-236 cfm, R2-80 cfm

Cleaning of Ducts...

NFPA 90A B-4 Inspection and Cleaning of Ducts.

B-4.1. Inspections to determine the amount of dust and waste material in the ducts (both discharge and return) should be made quarterly. However, if, after several inspections, such frequent inspection is determined to be unnecessary, the interval between inspections can be permitted to be adjusted to suit the conditions.

B-4.2 Cleaning should be undertaken whenever an inspection indicates the need.

Findings include:

During review of the facility's maintenance records it was found that on October 16-18, 2006, the hospital had their fire/smoke dampers tested by an outside vendor for proper operation. During the testing the vendor took pictures of the dampers. Many of the pictures showed large amounts of dust buildup within the plenum of the fire/smoke dampers. Staff I (Director of Facilities) was asked after showing the pictures to them, if the ventilation systems within the hospital had been cleaned by an outside vendor or not. Staff I stated the only thing that was done was to use a 2-3' duster since that is as far as they could reach but no outside vendor has cleaned the duct work.

Show Text of Violation

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record review, interview and review of the hospital medical records policy and procedure it was determined that the hospital failed to ensure that the medical record entries for 1 out of 3 closed patient records were complete, dated, timed and signed within thirty days. (Patient identifier is #41.)

Findings include:

Review of the hospital policy and procedure titled MEDICAL RECORD CONTENT AND MAINTENANCE revealed the following:

I. PURPOSE:

This policy addresses the process by which the Medical Records Department verifies that a medical record exists for every individual, both inpatient and outpatient evaluated or treated in the hospital. The term 'medical records'/ includes at least written documents, computerized electronic information ..., radiology reports, laboratory reports, pathology reports, and other forms of information regarding the condition of a patient. The staff of the Medical Records Department also ensure the records are accurately written, promptly completed, properly filed and retained, and accessible in accordance with the Conditions of Participation of the Centers for Medicare and Medicaid services, applicable state law and hospital policy...

III. RESPONSIBILITY:

C. The medical records department staff shall ensure the medical records are complete and conform to the documentation guidelines set forth in the Rules and Regulations of the Medical Staff, applicable state law, and CMS Conditions of Participation...

Review of the policy No. Med Staff #22 with a review date of 6/2012 Medical Record Compliance Policy, revealed the following:

IV. Procedures:

Medical record delinquencies, as defined in Rule 4 in the Rules and Regulations of Medical Staff, shall be addressed as follows: Providers will receive notification from the medical records department when a patient chart has been delinquent for 30 days,.. A second notification from the Chairperson of the Credentials Committee will be sent by certified mail after 60 days delinquency, indicating that if charts are not completed within 30 days, the provider will be considered to have voluntarily withdrawn his/her clinical privileges and membership from the Medical Staff...

The excerpts from Rules and Regulation of Medical Staff pages 45-47, revealed subsection

g. All orders...All verbal/telephone orders shall be authenticated, signed, dated and timed within 48 hours, with the exception of orders for restraints.

s. Each attending physician will be required to complete patient records, including dictation of a discharge summary, within 7 days after the Medical Records Department has finished assembly and analysis of these records... ii. Medical records, still incomplete after 30 days because of missing signatures, shall be considered delinquent.

Patient #41

Review of Patient #41's closed medical record on 3/27/13 revealed that Patient #41 was discharged from the hospital 1/17/13. Review of Patient #41's physician orders revealed several unsigned verbal orders by different physicians.

Interview with Staff A (Director of Medical Records), on 3/28/13 revealed that only emails had been sent out to the physicians for their delinquent signatures and that the department had not received any notification from the Medical Staff President that the provider would be considered to have voluntarily withdrawn his/her clinical privileges and membership for delinquency. Staff A indicated that Staff A talks with their office managers and sends emails and letters to get signatures.

Review of the List of Overdue Records (30 Days from Discharge) Report, revealed that Patient #41 does not appear on this list, even though Patient #41 was discharged from the hospital on [DATE].

Show Text of Violation

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record review, interview and review of the hospital medical records policy and procedure it was determined that the hospital failed to ensure that the verbal orders for 1 of 3 of the closed patient records and 1 of 25 inpatient records were complete, dated, timed and signed within 48 hours per hospital policy. (Patient identifiers are #27 and #41.)

Findings include:

Review of the hospital policy and procedure titled MEDICAL RECORD CONTENT AND MAINTENANCE revealed the following:

I. PURPOSE:

This policy addresses the process by which the Medical Records Department verifies that a medical record exists for every individual, both inpatient and outpatient evaluated or treated in the hospital. The term 'medical records' includes at least written documents, computerized electronic information ..., radiology reports, laboratory reports, pathology reports, and other forms of information regarding the condition of a patient. The staff of the Medical Records Department also ensure the records are accurately written, promptly completed, properly filed and retained, and accessible in accordance with the Conditions of Participation of the Centers for Medicare and Medicaid services, applicable state law and hospital policy...

III. RESPONSIBILITY:

C. The medical records department staff shall ensure the medical records are complete and conform to the documentation guidelines set forth in the Rules and Regulations of the Medical Staff, applicable state law, and CMS Conditions of Participation...

Review of the policy No. Med Staff #22 with a review date of 6/2012 Medical Record Compliance Policy, revealed the following:

The excerpts from Rules and Regulation of Medical Staff pages 45-46, subsection

g. All orders...All verbal/telephone orders shall be authenticated, signed, dated and timed within 48 hours, with the exception of orders for restraints.

Patient #41

Review of Patient #41's closed medical record on 3/27/13 revealed that Patient #41 was discharged from the hospital 1/17/13. Review of Patient #41's physician orders revealed several unsigned verbal orders by different physicians.

Interview with Staff A (Director of Medical Records), on 3/28/13 revealed that only emails had been sent out to the physicians regarding the delinquent signatures and that the department had not received any notification from the Medical Staff President that the provider would be considered to have voluntarily withdrawn his/her clinical privileges and membership for delinquency. Staff A indicated that Staff A talks with their office managers and sends emails and letters to get signatures.

Interview with Staff A on 3/28/13, confirmed that Patient #41's medical record is more than 30 days overdue. Staff A confirmed that Resident #41 did not appear on the List of Overdue Records (30 Days from Discharge) Report, even though Patient #41 was discharged from the hospital on [DATE].

Patient #27

Review of the medical record for Patient #27 on 3/27/13 and 3/28/13 identified three telephone/verbal physician orders written on 3/21/13. The orders lack the physician signatures as per the facility's policy. On 3/24/13 another verbal/telephone order was also documented in the medical record that lacks the physician signature within the 48 hours. On 3/22/13 there was another telephone order written where an order was taken with no identifiable prescribing physician documented in the medical record.

Show Text of Violation

Based on record review, interview and review of the hospital medical records policy and procedure it was determined that the hospital failed to ensure that the medical record entries for 1 of 3 closed patient records were complete, dated, timed and signed within thirty days. (Patient identifier is #41.)

Findings include:

Review of the hospital policy and procedure titled MEDICAL RECORD CONTENT AND MAINTENANCE revealed the following:

I. PURPOSE:

This policy addresses the process by which the Medical Records Department verifies that a medical record exists for every individual, both inpatient and outpatient evaluated or treated in the hospital. The term 'medical records' includes at least written documents, computerized electronic information ..., radiology reports, laboratory reports, pathology reports, and other forms of information regarding the condition of a patient. The staff of the Medical Records Department also ensure the records are accurately written, promptly completed, properly filed and retained, and accessible in accordance with the Conditions of Participation of the Centers for Medicare and Medicaid services, applicable state law and hospital policy...

III. RESPONSIBILITY:

C. The medical records department staff shall ensure the medical records are complete and conform to the documentation guidelines set forth in the Rules and Regulations of the Medical Staff, applicable state law, and CMS Conditions of Participation...

Review of the policy No. Med Staff #22 with a review date of 6/2012 Medical Record Compliance Policy, revealed the following:

IV. Procedures:

Medical record delinquencies, as defined in Rule 4 in the Rules and Regulation of Medical Staff, shall be addressed as follows: Providers will receive notification from the medical records department when a patient chart has been delinquent for 30 days,.. A second notification from the Chairperson of the Credentials Committee will be sent by certified mail after 60 days delinquency, indicating that if charts are not completed within 30 days, the provider will be considered to have voluntarily withdrawn his/her clinical privileges and membership from the Medical Staff...

The excerpts from Rules and Regulation of Medical Staff pages 45-47, subsection

g. All orders...All verbal/telephone orders shall be authenticated, signed, dated and timed within 48 hours, with the exception of orders for restraints.

s. Each attending physician will be required to complete patient records, including dictation of a discharge summary, within 7 days after the Medical Records Department has finished assembly and analysis of these records... ii. Medical records, still incomplete after 30 days because of missing signatures, shall be considered delinquent.

Patient #41

Review of Patient #41's closed medical record on 3/27/13 revealed that Patient #41 was discharged from the hospital 1/17/13. Review of Patient #41's physician orders revealed several unsigned verbal orders by different physicians.

Interview with Staff A (Director of Medical Records), on 3/28/13 revealed that only emails had been sent out to the physicians regarding the delinquent signatures and that the department had not received any notification from the Medical Staff President that the provider would be considered to have voluntarily withdrawn his/her clinical privileges and membership for delinquency. Staff A indicated that Staff A talks with their office managers and sends emails and letters to get signatures.

Interview with Staff A on 3/28/13, confirmed that Patient #41's medical record is more than 30 days overdue. Review of the List of Overdue Records (30 Days from Discharge) report, revealed Patient #41 does not appear on the list. Staff A confirmed that Patient #41 was not on the Overdue list when Patient #41 should have been.

Show Text of Violation

Based on observation, record review and interview it was determined that the hospital failed to maintain an effective grievance process for one emergency room patient by failing to document in-servicing to the staff for all identified concerns during care. (Patient identifier is #1.)

Findings include:

Tour of the emergency room (ER) on 7/2/12, with Staff E (Director Emergency Nursing and EMS) at approximately 1:00 p.m. revealed the following observations, the emergency room ambulance entrance has a set of full glass automated doors which lead from the ambulance entrance and emergency room parking lot. This set of doors opens to an ER hallway directly to ER Room 4 which contains two bays for patient care. Each bay has curtains which can be pulled to allowed privacy during care. ER Room 4 has a set of full view sliding glass doors which open to this hallway directly from the ER ambulance entrance.

Further observation revealed that an individual in the ER parking lot could see directly into the ER and into ER Room 4. Staff E confirmed this finding at the time of the emergency room observation tour and was aware that ER Room 4 was visible from the ER parking lot, ambulance entrance, unless the curtains was pulled during care.

Record review on 7/2/12 of the emergency room notes for Patient #1 dated 04/23/2012 revealed the following, 1835 Daughter to desk, tearful she stepped out for a minute and on return found patient had removed his IV (intravenous), taken off monitor leads, urinated on floor and removed all clothing. Pt (patient) very confused, assisted back to bed... 1855 22g to left AC (antecubital), pt placed back on monitor and O2 (oxygen).

Review of the hospital PATIENT RELATIONS WORKSHEET dated 5/1/2012, written by Staff B, (Risk Management), revealed the following;

Just wanted to let you know I received a call from ... in regards to a patient complaint. Daughter of patient [Patient#1]... called upset about her father's care in the Emergency Department. He was brought in from the ... Home with a fever and agitation. ...(physician name) had informed her that he was going to be admitted and encouraged her to step out and get something to eat. The primary nurse was not aware that the daughter left as she had been at the bedside with him since his arrival. Upon arrival back to the ER she could see her father through the ambulance doors and he was unclothed and had pulled his IV out. She expresses this was poor care....

Review of another letter signed by Staff B addressed to the daughter of Patient #1 dated May 1, 2012 showed the following:

I was recently made aware of an incident involving your father (Patient #1), which occurred while he was in our emergency room awaiting admission on April 23, 2012. It's my understanding that we failed to pass along information that you were leaving his bedside; and that this resulted in inadequate monitoring. While there was no untoward outcome or injury to your dad, we should have done better...I understand that following your meeting with Staff D, Clinical Coordinator of our Emergency Department, your experience was discussed at a departmental meeting; and all staff were reminded of the importance of hand-off communications, especially when patient safety is involved....I am very sorry for not monitoring ...(Patient #1) more closely once you left the Emergency Department...

During interview with Staff D and Staff E (Director of Emergency Nursing and (EMS)) on 7/2/12 at approximately 1:50 p.m. Staff D and E confirmed that Patient #1 was left unattended, had urinated on the floor, was unclothed and had removed the IV himself on the April 23, 2012 visit to the emergency room .

During interview with Staff F (V.P. Patient Care Services) and Staff G (Patient Safety/Risk Management) on 7/2/12 at approximately 2:10 p.m. it was confirmed that there is no documented evidence from the Emergency Department of a staff meeting or staff in-service

regarding the incident listed above for Patient #1 on April 23, 2012.

Cross reference #0143.

Show Text of Violation

Based on observation, record review and interview it was determined that the hospital failed to ensure the personal privacy for one emergency room patient. (Patient identifier is #1.)

Findings include:

Tour of the emergency room (ER) on 7/2/12, with Staff E (Director Emergency Nursing and EMS) at approximately 1:00 p.m. revealed the following observations, the emergency room ambulance entrance has a set of full glass automated doors which lead from the ambulance entrance and emergency room parking lot. This set of doors opens to an ER hallway directly to ER Room 4 which contains two bays for patient care. Each bay has curtains which can be pulled to allowed privacy during care. ER Room 4 has a set of full view sliding glass doors which open to this hallway directly from the ER ambulance entrance.

Further observation revealed that an individual in the ER parking lot could see directly into the ER and into ER Room 4. Staff E confirmed this finding at the time of the emergency room observation tour and was aware that ER Room 4 was visible from the ER parking lot, ambulance entrance, unless the curtains was pulled during care.

Record review on 7/2/12 of the emergency room notes for Patient #1 dated 04/23/2012 revealed the following; 1835 Daughter to desk, tearful she stepped out for a minute and on return found patient had removed his IV (intravenous), taken off monitor leads, urinated on floor and removed all clothing. Pt (patient) very confused, assisted back to bed... 1855 22g to left AC (antecubital), pt placed back on monitor and O2 (oxygen).

Review of the hospital PATIENT RELATIONS WORKSHEET dated 5/1/2012, written by Staff B, (Risk Management), revealed the following;

Just wanted to let you know I received a call from ... in regards to a patient complaint. Daughter of patient [Patient#1]... called upset about her father's care in the Emergency Department. He was brought in from the ... Home with a fever and agitation. ...(physician name) had informed her that he was going to be admitted and encouraged her to step out and get something to eat. The primary nurse was not aware that the daughter left as she had been at the bedside with him since his arrival. Upon arrival back to the ER she could see her father through the ambulance doors and he was unclothed and had pulled his IV out. She expresses this was poor care....

Review of another letter signed by Staff B addressed to the daughter of Patient #1 dated May 1, 2012 showed the following;

I was recently made aware of an incident involving your father (Patient #1), which occurred while he was in our emergency room awaiting admission on April 23, 2012. It's my understanding that we failed to pass along information that you were leaving his bedside; and that this resulted in inadequate monitoring. While there was no untoward outcome or injury to your dad, we should have done better...

I understand that following your meeting with Staff D, Clinical Coordinator of our Emergency Department, your experience was discussed at a departmental meeting; and all staff were reminded of the importance of hand-off communications, especially when patient safety is involved....I am very sorry for not monitoring ...(Patient #1) more closely once you left the Emergency Department...

During interview with Staff D and Staff E (Director of Emergency Nursing and (EMS)) on 7/2/12 at approximately 1:50 p.m. Staff D and E confirmed that Patient #1 was left unattended, had urinated on the floor, was unclothed and had removed the IV himself on the April 23, 2012 visit to the emergency room .

Respect us. Protect us. Pay us!

Frisbie Memorial Hospital

40 CMS Violations since 2012-07-02

Non Immediate Jeopardy Violations

Violation Name: PATIENT RIGHTS(A-0115) toolTips('.tooltip_post_id_custom_2201238b75b7049b80b353816ce59e1a','\<p\>\<span style\=\'color\:white;padding\:1px;font\-weight\:bold;min\-width\:500px\'\>A hospital must protect and promote each patients rights\.');

Violation Name: ACCESS TO LOCKED AREAS(A-0504) toolTips('.tooltip_post_id_custom_98bb3bcb6184acf972420108d86bb278','\<p\>\<span style\=\'color\:white;padding\:1px;font\-weight\:bold;min\-width\:500px\'\>\-º482\.25\(b\)\(2\)\(iii\) \- Only authorized personnel may have access to locked areas\.');

Violation Name: PATIENT RIGHTS: CARE IN SAFE SETTING(A-0144) toolTips('.tooltip_post_id_custom_2de97169726d21d843cf6a4abfba7588','\<p\>\<span style\=\'color\:white;padding\:1px;font\-weight\:bold;min\-width\:500px\'\>The patient has the right to receive care in a safe setting\.');

Violation Name: PATIENT RIGHTS: PERSONAL PRIVACY(A-0143) toolTips('.tooltip_post_id_custom_6502576cc282ca27624cf7d3c6699186','\<p\>\<span style\=\'color\:white;padding\:1px;font\-weight\:bold;min\-width\:500px\'\>The patient has the right to personal privacy');

Violation Name: PATIENT RIGHTS(A-0115)

Violation Name: ACCESS TO LOCKED AREAS(A-0504)

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

Violation Name: PATIENT RIGHTS: PERSONAL PRIVACY(A-0143)