Based on observation, interview, and record review, the facility failed to ensure that an effective infection prevention program to prevent the widespread transmission of COVID-19, in accordance with the CDC and CMS guidelines, and facility policy. The facility failed to : 1. effectively implement and monitor their COVID-19 screening process at 2 of 4 hospital entrances (Entrances A and C); 2. ensure staff wore required personal protective equipment (PPE); and wore PPE correctly (Entrances A and C). Findings: 1. COVID -19 screening process: CDC guidance : Record review of CDC Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic, June 19, 2020, recommended Screen and Triage Everyone Entering a Healthcare Facility for Signs and Symptoms of COVID-19. CMS guidance : Record review of Guidance for Infection Control and Prevention Concerning Coronavirus Disease (COVID-19)..[QSO-2013] dated 3-4-2020, showed direction for hospitals to identify visitors and patients at risk for having COVID-19 infection before or immediately upon arrival to the healthcare facility. They should ask about the following : Fever or symptoms of a respiratory infection, such as a cough and sore throat; International travel within the last 14 days to restricted countries... Contact with someone with known or suspected COVID-19.... Review of facility document titled Risk Level Planning, updated 4/01/2020, showed Entry Point management for patients/ visitors: * screeners at all entry points, * series of questions asked per protocol to include: positive COVID test within last 30 days, cough, shortness of breath, fever, nasal congestion, sore throat, diarrhea, chills, muscle pain, headache, new loss of taste or smell, exposure [close contact with lab confirmed positive or PUI ], travel history, and residence ( SNF, NH, etc.) Interview on 6/22/2020 at 1:35 PM, with Staff C, Chief Nursing Officer (CNO) , she confirmed that the Risk Level Planning document outlined the facility's current screening process. Surveyor #1 entry: no screening: (Entrance C) On 6/22/2020 at 9:53 AM, surveyor # 1 entered the facility via entrance labeled outpatient testing (Entrance C) from the parking garage. The surveyor did not see anyone inside the entrance and was able to access the facility freely and walk around and exit through another area of the hospital. On 6/22/2020 at 10:00 AM, surveyor # 1 again entered the facility via Entrance C , there was a staff member present at a desk. The staff member did not attempt to stop and screen the surveyor. The surveyor was able to walk freely through the facility, was passed by multiple staff members without question and was able exit via the main entrance of the facility. Surveyor # 2: incomplete screening: (Entrance A) On 6/22/2020 at approximately 10:10 AM, surveyor #2 entered the front entrance (Entrance A). Observation showed two (2) tables with a staff person at each table directly inside the entrance. Staff H (screener #1) asked surveyor to sanitize her hands; she then measured the surveyor's temperature. Surveyor then moved to the next table and was asked by Staff I (screener #2) about travel; Staff I then said symptoms? When asked by surveyor what symptoms? Staff I pointed to a sign and looked down. Surveyor #2 stood for a few minutes looking at the sign; the screener moved on to next person. Surveyor #2 left the table without answering the question symptoms? During an interview with Staff G, Infection Prevention Manager on 6/22/2020 at 11:40, she stated there are four entry points currently at the facility. There are screeners at each entry point. All staff and visitors are required to wear a mask when in the facility and it should cover the mouth and nose. During a telephone interview on 5/15/2020 at 1:00 PM, with Staff F, Infection Prevention Director, she stated that during the COVID pandemic, the entrances to the hospital were limited. Everyone was screened upon entry, screening involved a temperature check and asking a series of questions that included travel and health history. 2. PPE issues : Record review of CDC Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic, June 19, 2020, recommended Implement Universal Source Control Measures: HCP should wear a facemask at all times while they are in the healthcare facility, including in breakrooms or other spaces where they might encounter co-workers. Record review of facility document titled Universal Masking Notice read, All employees and visitors who enter the hospital must comply at all times with our Universal Masking policy. This policy requires that All employees, visitors, medical staff members, and other persons entering the hospital must remained masked at all times while in the facility except when consuming food or drink; Masks should completely cover the mouth and nose when being worn... Record review of facility email from Staff A, former CEO, dated 4/2/2020 stated that the mandatory universal masking policy is effective immediately, beginning with p.m. shift today, 4/2/20. Interview on 6/22/2020 at 1:35 PM, with Staff C, CNO, she said that the facility was at Level 3 CDC designation of confirmed widespread pandemic status. She stated that all staff and visitors were expected to comply with the Universal Masking Policy. Absence of Mask: 1. Physician K: Absence of PPE (mask) - (Entrance C): Observation on 6/22/2020 at 11:45 AM, during facility tour of COVID screening entry points with staff G (Infection Prevention Manager), Physician K entered via Entrance C, proceeded to the desk and received temperature check. He stated that he had no symptoms or exposures and was offered a mask by staff J, screening RN . He stated he would get a different kind. Physician K then sanitized his hands ; and was permitted to proceed into the facility without wearing a mask. Interview with staff G, Infection Prevention Manager, at the time of observation, stated Sometimes the physicians do not like the masks that are offered at the screening points and will get the one they want when they arrive on the unit. 2. Staff H : Absence of PPE (mask)-Entrance A On 6/22/2020 at approximately 10:15 AM, Staff H (screener #1) was observed reaching for a pair of gloves, she was not wearing a mask. There was a person standing at the table in front of her waiting to be screened. Improper wearing of PPE (mask) : Record review of CDC Facemasks Dos & Don'ts for HCP, dated 6-2-2020 showed : ...Put your face mask on so it fully covers your mouth and nose. Don't wear your face mask under your nose.. On 6/22/2020 at approximately 10:10 AM, surveyor # 2 entered the front entrance (Entrance A). Observation showed two (2) tables with a staff person at each table directly inside the entrance. Staff H ( screener #1) asked surveyor to sanitize her hands. Staff H was observed to be wearing her facemask below her chin. Staff H moved in closer to surveyor to check her temperature and said Oh! and pulled up her mask. Continued observation a few minutes later showed Staff H wearing her mask pulled beneath her nostrils. Observation on 6/22/2020 at 12:00 PM at Entrance A, Staff H (screener #1 ) was explaining the hospital's screening process to surveyor . Staff H's mask was covering her mouth only. Infection prevention manager instructed Staff H to cover her nose with her mask . Staff H complied and completed speaking with the surveyor without performing hand hygiene. Survey team informed facility leadership of an Immediate Jeopardy situation on 6/22/2020 at 2:30 PM related to COVID-19 infection prevention & control deficient practices.
Based on observation, interview, and record review, the facility failed to ensure an effective infection prevention program to prevent the widespread transmission of COVID-19 in accordance with the CDC guidelines and facility policy. The facility failed to : *effectively implement and monitor their COVID 19 screening process at 2 of 4 hospital entrances (Entrances A and C); *ensure staff wore required personal protective equipment (PPE), and wore PPE correctly (Entrances A and C) . Current deficient practices placed unknown numbers of patients, staff, visitors, and vendors at risk for serious illness and death due to potential widespread transmission of the COVID-19 virus. * Cross Reference A-750
Based on a review of documentation and interview, the facility failed to protect and promote each patient's rights. As evidence by: 1. Failing to ensure that the use of restraint was in accordance with the order of a physician or other licensed independent practitioner who is responsible for the care of the patient as specified under º482.12(c) and authorized to order restraint or seclusion by hospital policy in accordance with State law. The facility failed to obtain physician orders and/or appropriate restraint orders for restraints. Cross refer to A0168. 2. Failing to ensure that a restraint episodes were discontinued at the earliest possible time. As evidence by failing to release patient that was sleeping per documentation and failing to document the release of a patient from a separate restraint event. Cross refer to A0174. 3. Failing to ensure that the condition of the patient who is restrained was monitored by a physician, other licensed independent practitioner or trained staff that have completed the training criteria specified in paragraph (f) of this section at an interval determined by hospital policy. As evidence by failing to document/ assess a patient's physical condition including circulation and skin condition while in wrist restraints. Cross refer to A0175.
Based on a review of documentation and interview, the facility failed to ensure that the use of restraint was in accordance with the order of a physician or other licensed independent practitioner who is responsible for the care of the patient as specified under º482.12(c) and authorized to order restraint or seclusion by hospital policy. Findings: Facility based policy entitled, Patient Restraint/Seclusion stated in part, 5. Order for Restraint or Seclusion a. An order for restraint or seclusion must be obtained from an LIP/physician who is responsible for the care of the patient prior to the application of restraint or seclusion. The order must specify clinical justification for the restraint or seclusion , the date and time ordered, the duration of use, the type of restraint to be used and behavior-based criteria for release... b. If a telephone order is required, the RN must enter the order in CPOE while the physician is on the phone and read-back the order to verify accuracy. The order 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... A. Order for Restraint with Non-Violent or Non-Self-Destructive Behavior a. 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. 1. Twenty-four (24) hours is the maximum duration. The physician may order a shorter period of time. 2. Staff assess, monitor, and re-evaluate the patient regularly and release the patient from restraint when criteria for release are met. b. To continue restraint use beyond the initial order duration, the LIP/physician must see the patient, perform a clinical assessment and determine if continuation of restraint is necessary. c. If reassessment indicates an ongoing need for restraint, a new order must be written each calendar day by the LIP/physician. B. Order for Restraint with Violent or Self-Destructive Behavior a. 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: 1. Four ( 4) hours for adults, aged 18 years and older 2. Two (2) hours for children and adolescents aged nine (9) to 17 years, or 3. One ( 1) hour for children under nine (9) years i. The time frames specified are maximums. The physician may order a shorter period of time. ii. Staff assess, monitor, and re-evaluate the patient regularly and release the patient from restraint or seclusion when criteria for release are met. Review of the medical record for Patient #1 revealed the following restraint episode with no physician order present: * A nursing note on 07/15/18 at 1700 stated in part, Patient arrived with 4 point restraint from ER. Patient was sedated when he came, removed the restraint since patient is not currelt [sic] combative ... * On 07/15/18 a Restraint Monitoring Form (paper documentation) indicated that the that patient was monitored every 15 minutes from 1544 to 1630. At 1630 the form stated the patient was stable/sleep. The facility was unable to provide a documented physician order for the above episode of restraint. Review of the medical record of patient #1 revealed documented incidents of violent/self destructive behavior that jeopardized the immediate physical safety of staff members and/or the patient himself. However, the order for the patient's restraints was inappropriately maintained as an ongoing PRN order for medical restraints, rather than obtaining an order for violent or self-destructive (behavioral) restraint. * On 07/19/18 at 0525 a Non-Violent Restraint Non-Self Destructive Adult was ordered for soft bilateral wrist restraints with mittens tied to the side of the bed, the order was discontinued at 1045 on 07/20/18. * Documentation on 07/19/18 from 0000 to 1800 indicated the patient was in bilateral wrist restraints. At 0800 documentation indicated the patient had bilateral wrist restraints on due to agitated/kicking. The order for restraint indicated it was non-violent, however this documentation reflects violence (aggression) by the patient. The patient exhibiting violent behavior (agitated, kicking) would necessitate an order and documentation of this restraint as addressing violent (aggressive) behavior. * On 07/20/18 at 0933 a Non-Violent Restraint Non-Self Destructive Adult was ordered for soft bilateral wrist restraints and discontinued at 2157 on 07/21/18. * Documentation on 07/20/18 from 0000 to 1800 indicated the patient was in bilateral wrist restraints. At 0800 indicated the patient had bilateral wrist restraints on due to self-injurious behavior. The order for restraint indicated it was non-violent, however this documentation reflects self-destructive behavior (self injury) by the patient. The patient exhibiting self injurious behavior would necessitate an order and documentation of this restraint as addressing self-destructive behavior. The above documentation described violent and self destructive behaviors that jeopardized the immediate physical safety of the patient and staff members. These restraints were ordered and documented as non-violent restraints, the patient was in wrists restraints the majority of the these 2 days per documentation. Behavioral restraints can only be ordered for an amount of time not to exceed 4 hours, with a renewals required after each 4 hour period of time. A behavioral restraint also cannot be ordered PRN or as a standing order. The above incidents indicate the facility failed to obtain physician orders and/or appropriate restraint orders for these restraints episodes. The above finding was confirmed in an interview with staff member #1 on 11/27/18.
Based on a review of documentation the facility failed to ensure that a restraint episodes were discontinued at the earliest possible time. Findings included: Facility based policy entitled, Assessment Plan of Care stated in part, Restraints: Patient care strategies are geared to reduce and limit the use of restraints. If all alternatives fail and the patient is clearly at risk for injury to self or others, restraints may be considered. Should restraint use be implemented, the patient is reassessed according to timelines in policy and special attention is paid to safety, emotional and physical well-being, dignity, and meeting basic food/hydration and toileting needs. Reassessment is geared towards the early release of restraints in which the patient's safety and therapeutic regimen is protected and less restrictive measures are effective. Facility based policy entitled, Patient Restraint/Seclusion stated in part, 7. Monitoring the Patient in Restraints or Seclusion a. Patients are assessed by an RN immediately after restraints or seclusion are initiated to assure safe application/initiation of the restraint or seclusion. b. An RN will assess the patient at least every two (2) hours. The assessment will include where appropriate: 1. Signs of injury associated with restraint, including circulation of affected extremities 2. Respiratory and cardiac status 3. Psychological status, including level of distress or agitation, mental status and cognitive functioning 4. Needs for range of motion, exercise of limbs and systematic release of restrained limbs are being met 5. Hydration/nutritional needs are being met 6. Hygiene, toileting/elimination needs are being met 7. The patient's rights, dignity, and safety are maintained 8. Patient's understanding of reasons for restraint and criteria for release from restraint 9. Consideration of less restrictive alternatives to restraint... 11 . Discontinuation of Restraint or Seclusion: a. The patient in restraint or seclusion is evaluated frequently and the intervention is ended at the earliest possible time. The time-limited order does not require that the application be continued for the entire period. b. When an RN determines that the patient meets the criteria for release in the restraint order, restraint or seclusion are discontinued by staff with demonstrated competence. c. Once restraints or seclusion are discontinued, a new order for restraint or seclusion is required to reapply or reinitiate. d. A temporary release that occurs during patient care, e.g. toileting, feeding or range or motion, is not considered a discontinuation of restraint or seclusion. Review of the medical record for Patient #1 revealed the following documentation: * A nursing note on 07/15/18 at 1700 stated in part, Patient arrived with 4 point restraint from ER. Patient was sedated when he came, removed the restraint since patient is not currelt [sic] combative ... * On 07/15/18 a Restraint Monitoring Form (paper documentation) indicated that the that patient was monitored every 15 minutes from 1544 to 1630. At 1630 the form stated the patient was stable/sleep. * The patient was not released from restraint until transferred from the emergency department to an assigned room at 1700. The documentation at 1630 indicated the patient was sleeping. * Discontinuation at 1700 does not meet the criteria of release at the earliest possible time. * On 07/20/18 at 0933 a Non-Violent Restraint Non-Self Destructive Adult was ordered for soft bilateral wrist restraints discontinued at 2157 on 07/21/18. * Documentation on 07/20/18 from 0000 to 1800 indicated the patient was in bilateral wrist restraints. There was no documented release of the patient from restraints. The patient was discharged to another facility later in the day on 07/20/18. The above incidents reflect issues involving the release of a patient from restraints. The above findings were confirmed in an interview with staff member #1 on 11/27/18.
Based on a review of documentation, the facility failed to ensure that the condition of the patient who is restrained must be monitored by a physician, other licensed independent practitioner or trained staff that have completed the training criteria specified in paragraph (f) of this section at an interval determined by hospital policy. Findings included: Facility based policy entitled, Patient Restraint/Seclusion stated in part, 7. Monitoring the Patient in Restraints or Seclusion a. Patients are assessed by an RN immediately after restraints or seclusion are initiated to assure safe application/initiation of the restraint or seclusion. b. An RN will assess the patient at least every two (2) hours. The assessment will include where appropriate: 1. Signs of injury associated with restraint, including circulation of affected extremities 2. Respiratory and cardiac status 3. Psychological status, including level of distress or agitation, mental status and cognitive functioning 4. Needs for range of motion, exercise of limbs and systematic release of restrained limbs are being met 5. Hydration/nutritional needs are being met 6. Hygiene, toileting/elimination needs are being met 7. The patient's rights, dignity, and safety are maintained 8. Patient's understanding of reasons for restraint and criteria for release from restraint 9. Consideration of less restrictive alternatives to restraint... 12. Documentation Requirements: The medical record contains documentation of: a. Assessment for risk for restraint or seclusion b. Restraint or seclusion alternatives employed c. Determination of effectiveness/ineffectiveness of restraint or seclusion alternatives d. Second tier review of need for restraint or seclusion e. Order for restraint or seclusion and any renewal orders for restraint or seclusion f. Restraint or seclusion application/initiation g. Family notification of restraint or seclusion use h. Patient and family education regarding restraint or seclusion use i. Assessment of the patient in restraint or seclusion j. Monitoring of the patient in restraint or seclusion k. Medical and behavioral evaluation for restraint or seclusion management of violent or self-destructive behavior l. Modifications of the plan of care m. Physician notification of changes in patient condition n. Restraint or seclusion removal/termination Review of the medical record for Patient #1 revealed the following: * On 07/20/18 at 0933 a Non-Violent Restraint Non-Self Destructive Adult was ordered for soft bilateral wrist restraints and discontinued at 2157 on 07/21/18. * Documentation on 07/20/18 from 0000 to 1800 indicated the patient was in bilateral wrist restraints. There was no documented release of the patient from restraints. There was no documented assessment /evaluation of the patient every 2 hours per policy after 0600 on this date. This represents 12 hours where the patient's physical state including circulation and skin condition while in wrist restraints was not documented by nursing staff per facility based policy. The above finding was confirmed in an interview with staff member #1 on 11/27/18.
Based on a review of documentation, the facility failed to ensure a registered nurse must evaluate the nursing care for each patient, as evidence by failing to document appropriate pain assessments/indications for the administration of ordered pain medication. Findings included: Facility based policy entitled, Assessment Plan of Care stated in part, NURSING SERVICES... Registered Nurse... In accordance with the Texas State Nurse Practice Act, the practice of nursing involves:... * He [sic] administration of a medication or treatment as ordered by a physician, podiatrist, or dentist;... These conditions will be reported to the physician for further intervention or orders. Reassessments may also be based on the patients' diagnosis, desire for care, treatment and services; response to previous care, treatment and/or his or requests. Reassessment with appropriate documentation is based upon but not limited to: 1. response to treatment, medication... PAIN MANAGEMENT: All patients have the right to have their pain managed. This right is included in the brochure informing patients of their rights and responsibilities and patients are informed of this right at the time of admission... REASSESSMENT AND HOURLY COMFORT ROUNDS Comfort level is monitored and documented when comfort rounds are made by the primary nurse or nurse aide/nurse tech. Comfort rounds are normally made approximately every one to two hours. In the hours from 6 am to 10 pm every one hour rounds are expected. During the round, the nurse checks pain level, position and comfort changes, and that personal items are in reach. Non-pharmacologic interventions are performed as indicated such as reposition or back massage. If non-pharmacologic interventions are ineffective or inappropriate, the primary nurse will reassess the patient for the discomfort, intensity (patient self-perception). Medications administered are then documented with time, dosage, and route. Reassessment following intervention is performed to determine response to care and if further intervention is indicated. This documentation is found in PRN Medication Assessment/Reassessment screen of the Interventions within the Patient Care System. Review of the medical record for Patient #1 revealed the following: There was a PRN medication on 07/16/18 for Hydromorphone 1 mg IV PRN every 4 hours for pain severe 7 to 10. Review of medication administration for Patient #1 revealed the following: * On 07/18/18 the patient received Hydromorphone 1 mg at 0414, 0857, and 1315. * Appropriate pain assessments indicating a pain scale of 7-10 per physician order, were not documented by nursing staff on 07/18/18 when this medication was administered. * For the time period of 04:00-04:59 there was a documented pain assessment of no actual or suspected pain. No numeric or face pain scale was indicated. The pateint received hydromorphone 1 mg at 0414 from nursing staff with no pain indication documented. * At 0927 there was a documented pain assessment of yes actual or suspected pain. No numeric or face pain scale was indicated. The pateint received Hydromorphone 1 mg at 0857 from nursing staff with no pain indication of severe 7-10 documented. * At 1345 there was a documented pain assessment of yes actual or suspected pain. The pateint received Hydromorphone 1 mg at 0857 from nursing staff with no pain indication of severe 7-10 documented. According to documentation, on 07/18/18 around 1400 the rapid response team was contacted due to decreased oxygen saturations. The patient was subsequently placed on BiPAP and transferred to the ICU on this date after receiving the above pain medications, that did not have documented pain assessments indicating the need for administration based on the physician order parameters of pain severe 7 to 10. This medical record for Patient #1 indicated nursing staff administered pain medications that did not meet the criteria noted it the PRN physician order of pain severe 7 to 10. The nursing staff also failed to adequately assess and document the patient's pain scale when administered medication to indicate a need for this medication administration. This patient subsequently decompensated necessitating a transfer to a higher level of care in the ICU. The above finding was confirmed in an interview with staff member #1 on 11/27/18
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**
Based on record review and interview, the facility failed to ensure nurses maintained individualized nursing care plans on three (3) of three (3) current patients on the 3rd floor medical surgical/ observation unit (patient IDs #2, 4 and 6). Findings include: Record review of patient's (ID#2) medical record revealed admitted [DATE] with no nursing care plan. During an interview with patient (ID#2) on 8/14/2016 at 11:05, she stated she had been in the hospital for about 5 days. She had surgery on 8/10/17 to drain a painful abscess. She currently was receiving antibiotics and daily dressing changes by the nursing staff. Record review of patient's (ID#4) medical record revealed admitted [DATE] with a vaginal abscess. The patient's history and physical stated past medical history of chronic laryngitis, thyroid nodules, liver cirrhosis, type 2 diabetes mellitus and chronic respiratory failure. Nursing care plan for patient ID# 4 stated Fall Risk. During an interview with patient (ID# 4) on 8/14/2017, she stated that she has been in the hospital for about a week for an abscess that is now draining. She stated she has diabetes and receives oxygen through a nasal cannula. She is receiving antibiotics and sitz baths to help her infection. Record review of patient's (ID # 6) medical record on 8/14/2017 revealed no nursing care plan and the patient was admitted [DATE] with shortness of breath. She has a history of morbid obesity, congestive heart failure, chronic obstructive pulmonary disease and questionable obstructive sleep apnea. Interview with director of quality (ID# 52) on 8/15/2017 at 1030 revealed that nursing care plans should be created during the initial assessment and updated as needed. Nursing care plans should be individualized based on patient needs, diagnosis and level of understanding. Record review of facility policy titled Assessment Plan of Care dated 2012, pg 25 revealed the following information: A Registered Nurse initiates the plan of care for the patient. A priority of needs list (known as the plan of care) is initiated on admissions by a Registered Nurse. Staff members base care decisions on the identified patient needs and prioritize care needs on the plan of care to occur in a time frame that meets the patient's needs.
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