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Based on the onsite survey, completed August 17 and 18th 2021, the facility failed to comply with the regulations set forth for Life Safety, therefore, deficiencies were cited under Life Safety Code tags 211, 227, 281, 291, 325, 341, 345, 351, 353,355, 363,372,511, 521, 712,741,918,920,923. See survey event ID #OFEA21 for full details of the cited deficiencies.

Based on observations, interviews and document review, the facility failed to ensure patient care equipment was maintained and safe for use in two out of two locations observed. Multiple pieces of equipment with out of date maintenance stickers were found at the critical access hospital (CAH) as well as the clinic.

Findings include:

Facility policy:

The Biomedical policy read , medical equipment with electrical power must be tested according to the device Manufacture's instruction for use (MFU ), normally on a 12 month schedule.

1. The facility failed to perform preventative maintenance (PM) on patient care equipment.

a. On 7/20/21 at 1:48 p.m., a tour was conducted of the perioperative and operative area. During the tour it was observed:

i. Kendall Sequential Compression Device (SCD) (inflatable sleeves around the legs and attached to a pump which inflates and deflates the sleeves to prevent blood clots) with a PM sticker with the due date of 6/2016.

ii. A second Kendall SCD machine had a PM sticker with the due date of 6/18 .

iii. Delfi portable tourniquet system (a device placed around a bleeding arm or leg) had a PM sticker with the due date of 8/18.

iv. Bair Hugger temperature management unit (a non-invasive solution for monitoring core body temperature) had a PM with the due date of 3/17.

b. On 7/21/21 at 9:45 a.m., a tour was conducted at the clinic. During the tour it was observed:

i. Welch Allyn SureTemp Plus thermometer (a device which measured temperature), in the trauma room. The PM sticker read, the PM was last done 3/17 and was due on 3/18.

ii. Medline Vac-Assist Suction Unit (used for removing obstructions such as mucus, saliva, blood, or secretions from a person's airway). , on the crash cart (wheeled container carrying medicine and equipment for use in emergency resuscitations). PM sticker read, the PM was last done 3/17 and was due 3/18.

iii. Cardio Touch electrocardiogram (EKG) Machine (a device which evaluated the electrical signal from the heart). The PM sticker read the PM was last done 3/17 and was due 3/18.

iv. Lifepak CR2 Defibrillator (a device which restored a normal heartbeat by sending an electric pulse or shock to the heart) on the crash cart. The PM was last done 12/19 and was due 12/20.

v. Welch Allyn automated external defibrillator (AED) (a portable, life-saving device to treat sudden cardiac arrest, a medical condition in which the heart stops beating) in the medication room. Licensed Practical Nurse (LPN) #6 stated it was the backup to the AED on the crash cart. The battery was replaced 10/12 and had no due date on the sticker.

vi. Welch Allyn Vitals Machine (measures blood pressure, temperature, and pulse rate), in the exam room. The sticker read, the PM was last done 3/17 and was due 3/18.

vii. Manual scale (a device to measure weight), in the examination room. The sticker read, the PM was last done 3/17 and was due 3/18.

c. On 7/20/21 at 5:15 p.m., an interview was conducted with Facility Manager #15. Manager #15 stated he oversaw the maintenance of the equipment in the hospital and the clinic. He stated the PM consisted of making sure there were no frayed wires on devices. Manager #15 stated PMs were done once a year on medical equipment and no logs were kept to keep track which PMs had been completed.

d. On 7/26/21 at 4:35 p.m., an interview with Registered Nurse (RN) #5 was conducted. RN #5 stated she was aware the medical equipment had a PM sticker attached, but was unaware the equipment had past due dates. RN #5 stated if the equipment was not maintained there was a risk to patients because the equipment could malfunction.

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §485.635 Condition of Participation: Provision of Services was out of compliance.

C-1016 (iv) Rules for the storage, handling, dispensation, and administration of drugs and biologicals. These rules must provide that there is a drug storage area that is administered in accordance with accepted professional principles, that current and accurate records are kept of the receipt and disposition of all scheduled drugs, and that outdated, mislabeled, or otherwise unusable drugs are not available for patient use. Based on observations, interviews and document review, the facility failed to ensure medications were stored, secured and administered according to facility policy. Specifically, the facility failed to ensure medications were stored securely to prevent unauthorized access. In addition, the facility failed to ensure expired medications were removed and not available for administration to patients in three of four patient care areas.

C-1048 A registered nurse or, where permitted by State law, a physician assistant, must supervise and evaluate the nursing care for each patient, including patients at a SNF level of care in a swing-bed CAH. Based on interviews and document review, the facility failed to ensure a registered nurse (RN) reviewed and evaluated nursing care provided by a certified nursing assistant (CNA) in three of three medical records reviewed in which abnormal vital signs were not reported to the RN. (Patient #6, Patient #8 and Patient #12).

Based on observations, interviews and document review, the facility failed to ensure medications were stored, secured and administered according to facility policy. Specifically, the facility failed to ensure medications were stored securely to prevent unauthorized access. In addition, the facility failed to ensure expired medications were removed and not available for administration to patients in three of four patient care areas.

Findings include:

Facility policies:

The Dating of Sterile Products policy read, sterility and safety of products is required. The length of time medication can be used after manipulation, compounding, activating or opening is as follows: Single dose vials (SDV) of medication will be discarded immediately after use. Multidose vials (MDV) will be discarded once empty, when contamination occurs, or 28 days after opening. Intravenous (IV) Solutions and Minibags must be administered immediately and will not hang more than 24 hours due to medication stability. Medications will be labeled with a 'Medication Added' label.

The Pyxis Pharmacy Floor Stock System policy read, medication storage outside of the Pyxis
must be stored within locked medication rooms doors or locked refrigerators. Medications stored within the nursing station must be monitored at all times by a Registered Nurse (RN), Licensed Practical Nurse (LPN), Certified Registered Nurse Anesthetist (CRNA).

The Medications in the Perioperative Setting policy read, medications will be locked in the perioperative medication cabinet until needed for the day. Medications may be taken to the OR at the time the patient enters the room.

The Medication Policy read: A secure environment of care is needed for medication safety, which includes the security of drugs used for elective and emergency patient care. Security of medications in the operating room is essential for patient safety. Medication is to be locked in the perioperative medication cabinet.

References:

Humalog MFU read: Humalog is a rapid acting insulin used to improve glycemic control in adults and children with diabetes mellitus. Storage and handling- After vials have been opened: Stored opened vials in the refrigerator for up to 28 days. Throw away all opened vials after 28 days of use, even if there is insulin left in the vial.

Humulin R MFU read: Humulin is a short acting insulin used to improve glycemic control in adult and pediatric patients with diabetes mellitus. Storage conditions and expiration dates: In use (opened) refrigerated: can be used for 31 days.

Rocuronium Bromide MFU read: Rocuronium is a neuromuscular blocking agent used with general anesthesia. To be administered only by experienced clinicians or adequately trained individuals familiar with reactions, characteristics and complications of neuromuscular blocking agents. Use only if facilities for intubation, mechanical ventilation, oxygen therapy and an antagonist are immediately available. Severe anaphylaxis has been reported. Accidental administration can cause death.

Succinylcholine Chloride MFU read: Succinylcholine Chloride is a skeletal muscle relaxant. Administration results in paralysis which may lead to respiratory arrest and death; this progression is more likely to occur in a patient for whom it is not intended.

Multistix 10 SG reagents MFU read: Once the canister is opened the remaining strips are stable for up to three months.

BD Vacutainer Evacuated Blood Collection System MFU read: Tubes expire on the last day of the month and year indicated. Do not use tubes after their expiration date.

1. The facility failed to ensure expired medication and supplies were removed from inventory and not available for patient use.

a. Facility observations on 7/20/21 at 9:20 a.m., revealed expired or unlabeled vials which specified the expiration dates in the Pyxis (an automated medication dispensing system) refrigerator in the medication room.

i. Two Humalog Insulin three ml vials, both opened with no date written on the vials to specify when the vial was opened or the use-by date.

ii. One Humulin R insulin vial which was opened and labeled with a patient's name and had the date 4/9/21 written on the vial.

b. Chief Nursing Officer (CNO) #13 was present and stated MDVs were to be labeled when they were opened with the date and the beyond use date. CNO #13 was unable to validate if the medications were safe for patient use due to the missing dates and stated the vials needed to be disposed of.

c. An interview with RN #3 was conducted on 7/26/21 at 5:14 p.m. RN #3 stated MDV were to be labeled with the expiration date when opened. RN #3 stated MDV insulin expired 30 days after it was opened. RN #3 stated if a MDV had no date written on the bottle, it was to be discarded. RN #3 stated if an expired medication was administered to a patient, there was a risk of lost potency or the possible presence of bacteria.

2. The facility failed to ensure medications were stored securely and not available to unauthorized personnel.

a. On 7/20/21 at 1:45 p.m., the perioperative area was observed. Upon observation, it was noted the medication refrigerator was unlocked. The unlocked medication refrigerator contained the following medications:

i. One vial of Succinylcholine (a medication used to cause short-term paralysis as part of general anesthesia)

ii. One vial Rocuronium (a muscle relaxant used in anesthesia, to facilitate endotracheal intubation)

iii. One box Urease Test (used to test for Helicobacter pylori- a bacteria which infects the stomach)

iv. One vial of Vasopressin (a medication which increases blood flow to the heart and brain)

v. One vial of Humulin R insulin (a medication used to control blood sugar).

b. RN #5 was present during the observation and stated the medication refrigerator was never locked and was unable to be locked. RN #5 stated the door to the perioperative area was locked at night, but facility housekeeping cleaned all areas of the facility which included the medication area at night.

c. On 7/20/21 at 3:58 p.m., Pharmacist #11 was interviewed. Pharmacist #11 stated the refrigerator in the perioperative nurses area had been locked once the surveyors identified the unsecured medications. Pharmacist #11 stated she was unaware of the length of time the medications had been kept in the unlocked refrigerator. Pharmacist #11 stated the medications kept inside of the refrigerator were Succinylcholine and Rocuronium, which were paralyzing agents used for emergency intubations (a procedure used when a patient is unable to breathe on their own). Pharmacist #11 stated the medications were to be secured unless a staff member was present.

d. On 7/27/21 at 9:31 a.m., a second interview was conducted with Pharmacist #11. Pharmacist #11 stated the high risk medications in the perioperative refrigerator needed to be secured to prevent unauthorized access. Pharmacist #11 revealed Succinylcholine and Rocuronium were paralytic agents and could cause death if administered by anyone other than anesthesia. She stated Vasopressor could cause a stroke if it was administered and not needed. Pharmacist #11 stated insulin if given incorrectly, could cause hypoglycemia (low blood sugar) leading to coma and possible death.

3. The facility failed to ensure expired medications and supplies were removed and not available for use .

a. On 7/20/21 at 1:45 p.m., an observation was conducted of the supply cabinet in the perioperative area of the critical access hospital (CAH). The observation revealed the following:

i. One 0.9% saline flush (a medication used for clearing intravenous lines) with an expiration date of 1/24/21.

ii. Five black and red top vacutainers (plastic tubes used to collect blood) with expiration dates of 9/30/20. The MFU read, do not use the tubes after the expiration date .

iii. 10 Formalin containers (a substance used as an antiseptic or disinfectant). Five had expiration dates of 11/19, three had expiration dates of 4/20 and two had expiration dates of 6/20.

RN #5 was present during the observations and stated supplies could not be used past their expiration date.

b. On 7/21/21 at 9:45 a.m., an observation was conducted at the clinic. The observation revealed:

i. One tube of Surgilube surgical lubricant sterile bacteriostatic (a lubricant), in the laboratory room with an expiration date of 11/20.

ii. Multistix 10 SG reagents (a substance for use in chemical analysis) were opened on 9/01/20 and expired 8/31/21. The MFUs read, once the canister was opened, the remaining strips were stable up to 3 months.

iii. Two opened bottles of Tetracaine hydrochloride ophthalmic solution (eye drops used to numb the eye) 0.5 % single use eye drops. The package read, sterile until opened.

LPN #6 was present during the observation and stated the eye drops were for single use only.

iv. One Box of 50 Magellan needles had an expiration date of 5/21.

v. 12 bottles of Ensure Original Therapeutic Nutrition bottles were observed in the medication room. Eight bottles expired 4/1/21 and four bottles expired 6/1/21.

LPN #6 was present during the observation and stated Ensure shakes were given to patients with nutritional issues. She stated they couldn't be given to patients after they expired .

c. On 7/27/21 at 11:14 a.m., Clinic Manager #10 was interviewed. Clinic Manager #10 stated he was unaware of expired supplies in the clinic. Clinic Manager #10 stated the expired supplies were to be removed from the clinic and not used. Clinic Manager #10 stated the annual competencies had not been conducted with staff in 2020, and the last competencies were done in August 2019. Clinic Manager #10 stated there was a risk of infection to the patient if expired supplies and medications were used.

Based on interviews and document review, the facility failed to ensure a registered nurse (RN) reviewed and evaluated nursing care provided by a certified nursing assistant (CNA) in three of three medical records reviewed in which abnormal vital signs were not reported to the RN. (Patient #6, Patient #8 and Patient #12).

Findings include:

Facility policy:

The Assessment Documentation policy read, shift assessments and reassessments will be performed and documented by the registered nurse (RN) or the licensed practical nurse (LPN). Reassessment documentation will be done following a change in the patient's condition, in accordance with physician orders and as needed per nursing staff process and procedure. A patient assessment was defined as the physical review of a patient. Nursing staff will document the patient's current condition, intervention and treatments and any changes in the patient s condition or plan of care.

Vital signs are measurements of the heart rate, blood pressure, blood oxygen level and respiratory rate. Vital sign measurements (vital signs) will be performed every four hours by the nursing staff. The RN will review vital sign measurements routinely. Vital sign measurements not within normal limit (WNL) parameters are considered a change in patient condition. Nursing interventions related to a change in patient condition will be documented

The Standards of Nursing Practice/Standard of Care policy read, the RN will collect data related to the patient's health and current medical situation. The data collected will be communicated to other healthcare providers and nursing staff caring for the patient. The RN will collaborate with nursing staff and the patients' healthcare team on a continued basis to evaluate and review patient care. The RN will implement evidence-based interventions when appropriate. The RN will continually assess the patient and update the plan of care and expected outcomes for the patient.

Facility references:

The Nurse/Physician Notification Guidelines read, CNA's and technicians were to notify the patients RN when abnormal vital signs occurred. The RN will reassess abnormal vital signs and notify the patient's physician of the change in patient condition. Abnormal vital signs include: Elevated body temperature (a fever) greater than 100.4 degrees Fahrenheit, blood pressure greater than 180/100 or less than 100/60, respiratory rate less than 20.

1. The facility failed to ensure abnormal vital signs were reported to the RN and subsequent assessments and evaluations were performed.

a. Interviews with staff revealed abnormal vital signs obtained by the CNA were to be reported to the RN so subsequent assessments and treatments could occur.

i. On 7/22/21 at 11:44 a.m., an interview was conducted with Certified Nursing Assistant (CNA) #9. CNA #9 stated patient vital signs were performed every four hours. CNA #9 stated all vital sign measurements normal and abnormal were documented in the patient's medical record. CNA #9 stated vital sign measurements not WNL were considered abnormal. CNA #9 stated she was required to inform the RN caring for the patient when patient vital sign measurements were abnormal. She stated she was to document in the patient medical record the name of the RN and the time the RN was informed of the abnormal vital signs.

CNA #9 stated when the RN was informed a patient had abnormal vital signs, the RN assessed the patient and obtained new vital signs. CNA #9 stated the RN would notify the physician caring for the patient of the abnormal vital signs. CNA #9 stated the physician would provide care recommendations and orders if needed. Subsequently, she stated abnormal vital signs could indicate the patient's medical condition worsened, and if not treated could harm the patient.

ii. On 7/22/21 at 12:20 p.m., an interview was conducted with Registered Nurse (RN) #1. RN #1 stated CNA's performed patient vital signs every four hours and the RN reviewed and evaluated patient vital signs.

RN #1 stated CNA's use the Nurse/Physician Notification Guidelines to determine when vital signs were WNL or abnormal. She stated if the patient's vital signs were abnormal, the CNA would inform the RN of the abnormal vital sign readings. RN #1 stated the RN would reassess the patient and obtain new vital signs for the patient. She stated the physician was notified of any abnormal vital signs immediately following reassessment by the RN. RN #1 stated the physician would inform the RN of how to proceed and if follow up orders were entered for the patient. She stated the RN was required to document the time the CNA relayed the abnormal vital signs, when the RN reassessed vital signs, the time the physician was contacted and the treatment recommendation the physician provided.

RN #1 stated abnormal vital sign readings could indicate the patient was anxious, had worsening cardiac (heart) problems or experienced a stroke. She stated patients were at risk for harm and potential medical complications when abnormal vital signs were not reviewed and evaluated.

b. A review of patient records revealed from 9/5/20 to 3/6/21 patient records lacked evidence of reporting, assessment and evaluation of abnormal vital signs. Examples include:

i. Record review of vital signs for Patient #6 revealed evidence of eight abnormal vital sign episodes. The medical record had no evidence six abnormal vital sign events were reported to the RN for further assessment and evaluation.

ii. Record review of vital signs for Patient #8 revealed evidence of 19 abnormal vital sign episodes. The medical record had no evidence six abnormal vital sign episodes were reported to the RN for further assessment and evaluation.

iii. Record review of vital signs for Patient #13 revealed evidence of four abnormal vital sign episodes. The medical record had no evidence four abnormal vital sign episodes were reported to the RN for further assessment and evaluation.

These examples were in contrast to the Nurse/Physician Notification Guidelines which read the RN was to be notified of abnormal vital signs and would notify the patient's physician of the change in patient condition.

Based on observations, interviews and document review, the facility failed to ensure staff performed hand hygiene and glove use according to national standards and facility policy based on one of one patient care observations.

Findings include:

Facility policies:

The Isolation and Transmission Based Precautions policy read, precautions are used to prevent the transmission of infectious agents, communicable diseases and blood borne pathogens. Standard precautions (SP) prevent the transmission of microorganisms and will be used when interacting with blood, body fluids and patient surroundings. SP practices include but are not limited to, the use of hand hygiene and personal protective equipment (PPE) during patient interactions.

Hand hygiene consists of hand washing and the application and rubbing of alcohol-based sanitizer to the hands. Hand washing must be performed when visible contamination or soiling of the hands occurred. Use of alcohol-based hand sanitizer is performed when hands are not visibly soiled or contaminated. Either hand washing or hand rubbing must occur before and after glove use and before and after direct contact with the patient, the patients' surroundings, and upon entrance and exit of the patient environment. Subsequently, hand hygiene must occur before the insertion of catheters or any invasive devices.

PPE are specialized clothing or equipment used by healthcare workers for protection from blood, bodily fluids and potentially infectious materials. Gloves, face masks, gowns and face shields or goggles are considered PPE. Gloves will be worn when venipuncture and vascular procedures are performed. Before donning gloves and after doffing gloves hand hygiene will be performed. Gloves will be replaced when contaminated or when the barrier integrity has been compromised.

References: The Center for Disease Control (CDC), Healthcare Providers, Clean Hands Count for Healthcare Providers, updated 1/8/21 read, hand hygiene reduces the spread of infections and disease. Hand hygiene must be performed immediately before touching a patient, prior to the placement of an indwelling catheter or intravenous catheter, before and after physical contact with a patient and their immediate surroundings, after contact with bodily fluids and contaminated surfaces and immediately after gloves are removed. Additionally, glove use must occur when standard precautions are implemented and glove use is not a replacement for hand hygiene. Healthcare providers must perform hand hygiene before donning gloves and after gloves are removed.

1. The facility failed to ensure staff performed hand hygiene and glove use according to policy and national standards to reduce the risk of infection.

a. On 7/21/21 at 10:15 a.m., an observation was conducted of the outpatient lab draw area. Licensed Practical Nurse (LPN) #6 was observed to have the glove on, but missing the finger portion to her left index finger during the venipuncture of a patient's arm. LPN #6 was observed removing the gloves after the procedure, but failed to wash her hands or perform hand hygiene.

b. According to references and policies listed above, hand hygiene was required before direct contact with the patient, before and after venipuncture and vascular procedures were performed and after exposure to bodily fluids. Glove use was not a replacement for hand hygiene. Gloves were required to be removed and hand hygiene performed when gloves were contaminated or the integrity of the gloves became compromised. Additionally, staff must perform hand hygiene before gloves were donned and after gloves were doffed.

c. On 7/27/21 at 8:47 a.m., LPN #6 was interviewed. LPN #6 stated she cut the tip of the glove off to feel the patient's vein. LPN #6 stated that the clinic was busy and she was stressed and this was not her usual practice. LPN #6 stated there was a risk of infection to the patient with the glove tip removed .

d. On 7/27/21 at 11:14 a.m., Clinic Manager #10 was interviewed. Clinic Manager #10 stated medical staff were expected to follow the policy. He stated gloves were to remain intact when procedures were performed.

e. On 7/21/21 at 4:34 p.m., Chief Nursing Officer (CNO) #13 was interviewed. CNO #13 stated gloves were to be worn by staff per the policy. CNO # 13 stated if gloves were not intact they were to be changed to prevent contact with bodily fluids. CNO # 13 stated that there was a risk of infection to the patient and staff, if staff did not wear gloves and perform hand hygiene per policy. CNO #13 stated the policy was from the National Standard from the CDC for infection prevention.

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §485.641 Periodic Evaluation and Quality Assurance Review was out of compliance.

Based on interviews and document review, the facility failed to ensure the quality assurance performance improvement (QAPI) program defined individualized priorities to be implemented and maintained to reduce adverse safety events. Additionally, adverse safety events and patient safety processes were not investigated, analyzed or tracked in order to identify contributing factors, implement preventive measures and prevent recurrence in six of nine adverse safety events reviewed (Patient #7, #8, #9, #10, #18 and #19). (Cross-reference C1612)

Findings include:

Facility policies:

The Occurrence Reporting policy read, risk will be identified, assessed, and reduced for patients, visitors, staff and employees. Occurrences and circumstances related to the occurrence will be documented, tracked and trended. Occurrence Reports will be completed and provided to the Risk Management Department.

An occurrence is defined as an event not consistent with routine facility operation or routine care of a patient. Subsequently, incidences are defined as occurrences. The following patient safety events are considered occurrences: patient abuse (verbal, physical and sexual), brain injuries, burns, spinal cord injuries, death, diversion of drugs, life threatening transfusions error or reactions, medication errors/near miss, malfunction/misuse of equipment, misappropriation of a patients property, missing patients or staff, patient neglect, falls, intentional or unintentional patient harm, physical/verbal altercations, theft, termination of services against medical advice (AMA), and events which create the potential for monetary loss are considered occurrences.

Staff will complete occurrence reports within eight hours after their shift. The attending Physician and the Director of Nursing (DON) will be notified of all occurrences involving patients. The Pharmacist will be notified of medication errors and medication related occurrences, additionally the Medication Occurrence Form will be utilized.

The Risk Manager will review and investigate occurrences. Occurrences will be presented quarterly to the Medical Staff, Safety Committee, Performance Improvement (Quality Assurance) Committee and the Board of Directors. Additional review and follow up will be performed by the CEO, Risk Management, the Quality Assurance Committee, and the Safety Committee.

Facility programs/plans:

The Quality Assurance and Performance Improvement Plan (QAPI plan) for 2021 shall be based on data collection and analysis, the quality of patient care and patient service delivery system efficacy and efficiency.

Quality indicators were developed to monitor and measure the process stability of patient care, the delivery of patient care and patient care outcomes. Development of new quality indicators occurred from patient care processes and outcomes identified as high risk, high volume and potentially problematic.

Performance and quality of care data are collected from patient events, internal occurrence reports, safety program review, risk management reports, patient and family surveys, department logs, patient medical records, hospital information systems and internal and external monitoring. All data will be collected and used to identify process outcome concerns, problems and variations.

Patient care processes are changed and improved through utilization of the Plan, Do, Study, Act (PDSA) cycle. PDSA methodology: Plan: identify the process to be improved, define measurable goals, clarify how the current process worked, perform data collection and a root cause analysis, develop a plan to address the root cause and determine the new process to implement. Do: perform an intervention, implement the new process. Study: analyze the data from the intervention and the effect of the process. Act: improved processes are implemented. The PDSA methodology and cycle will be utilized to update performance measures and implement the identified process solutions.

The Board of Directors are responsible for the QAPI plan. The Chief Executive Officer (CEO) will appoint a Quality Manager and the medical staff and administrative staff will implement the QAPI plan throughout the facility. A Quality Committee composed of staff members from clinical departments and the medical staff. The Quality Committee will prioritize, integrate, and coordinate performance improvement activities identified within the QAPI plan. The Quality Committee meeting minutes and activities reflect patient service problem identifications, results, findings, conclusions, recommendations and implemented actions. The Quality Committee meeting minutes are communicated and reviewed by the Board of Directors and medical staff.

The performance improvement activities within the QAPI plan include: infection control and prevention, risk management and safety, adverse event reviews, adverse patient event reviews, patient safety reviews, health information management, provision of medical services, nursing care and services, surgical and anesthesia case reviews, mortality and morbidity reviews, prescribed medication evaluations, blood transfusion and usage reviews, pharmacological and therapeutic reviews of medication, radiology/imaging services, dietary and nutrition services, occupational and physical therapy services, social work and case management services, equipment and utility service management, facilities utilization and reviews and outpatient laboratory and clinical services. Subsequent targeted quality indicators include long term financial stability, patient centered healthcare, community outreach and employee education.

The Quality Committee and the Medical Staff evaluate the objectives, scope and effectiveness of the QAPI plan. Reviews and revisions to the QAPI plan will occur bi-annually and as needed. Focus of the QAPI plan will be on areas of improvement, evaluation of process objectives, scopes of service and process effectiveness. Senior leadership, the Quality Committee and department heads will update and revise the QAPI plan. The Governing Board will be responsible for the approval of updates and revisions to the QAPI plan.

1. The facility failed to ensure adverse safety events were reviewed, evaluated, investigated, and analyzed in order to prevent recurrence.

A. Documents were reviewed.

a. According to the Quality Assurance and Performance Improvement Plan for 2021, patient care processes and outcomes were reviewed to identify quality improvement indicators. High risk, high volume patient care processes and outcomes provided quality indicators for areas of process improvement. Internal occurrence reports, adverse safety events, safety program review, risk management reports, department logs, patient medical record review and the hospital information systems would provide the data collected and used to identify patient care process outcome concerns, problems and variations.

b. According to the Occurrence Reporting policy, occurrences were adverse safety events, situations and incidents which occurred at the facility and impacted patients, patient care and patient outcome. These included: Patient falls, patient injuries, patient harm and medication errors/near misses were reported as occurrences.

c. A review of adverse safety events from 7/1/20 through 7/21/21 revealed the facility failed to investigate adverse safety events and lacked implementation of preventive measures to reduce the risk of patient harm.

The Quality Assurance and Performance Improvement Plan for 2021 and the Occurrence Reporting policy stated adverse safety events will be investigated, reviewed, evaluated, analyzed, tracked and trended by members of the medical staff and administrative staff in order to prevent patient harm and adverse safety event recurrence.

Examples of patient safety events include:

i. On 11/19/20 at 4:42 p.m., Patient #8 was admitted. Eleven days later on 11/30/20 at 7:30 p.m., an adverse safety event was reported.

Patient #8's bed alarm sounded. Patient #8 was found in bed with his left leg hooked inside the left lower side rail of the bed. Patient #8's left hip dislocated and needed to be relocated (a procedure where the femoral head of the hip is placed back into the hip socket). The relocation procedure was performed and required the use of conscious sedation (a shortened sedation which generally lasts 15-30 minutes).

ii. Patient #7 was admitted on 10/5/20 at 12:58 p.m. Patient #7's physician placed a medication order on 10/5/20 at 10:00 p.m. for Patient #7 to be administered Clonazepam (a medication prescribed to treat epilepsy, involuntary muscle spasms, panic disorders and restless legs syndrome) three times a day while hospitalized.

Six days later on 10/11/20 at 7:30 p.m., an adverse safety event was reported. The Registered Nurse (RN) for the patient found a home prescription bottle for Clonazepam in the front pocket of Patient #7's clothing. Patient #7 disclosed to the RN he self-administered doses of Clonazepam in addition to the doses ordered by the inpatient physician.

iii. Patient #19 was admitted on 12/9/20 at 5:02 p.m., an adverse safety event was reported at 7:30 p.m.

The RN administered IV antibiotics to Patient #19's peripheral intravenous (PIV) site. Patient #19 was not prescribed IV antibiotics. The RN acknowledged the error and disconnected the IV antibiotics.

iv. Patient #9 was admitted on 1/21/21 at 7:06 p.m. Patient #9 had a right femoral vein central line catheter (a long thin and hollow plastic tube inserted into the large vein located deep within the right upper thigh) removed on 1/24/21 at 1:15 p.m. The RN applied direct pressure (a procedure performed after removal of a central line catheter to prevent excessive bleeding and bruising) and applied a dressing. At 1:30 p.m. an adverse safety event was reported. The wound on Patient #9's right upper thigh hemorrhaged (severe uncontrolled bleeding).

v. Patient #18 was admitted for observation on 2/25/21 at 3:50 p.m. Six hours later at 10:00 p.m. an adverse safety event was reported.

The RN found a home medication pill case in the patient's room. Patient #18 disclosed he administered his home medications while in his hospital room. Patient #18 was not able to disclose the names of the medications, the number of medications or the time he administered the medications.

vi. Patient #10 was admitted for observation on 7/19/21 at 11:33 p.m. At 6:00 p.m. the RN documented Patient #10 disclosed he experienced falls associated with dizziness when at home. Additionally, Patient #10 had neuropathy (numbness, tingling, muscle weakness and pain as a result of damage to the nerves) in his lower extremities.

On 7/20/21 at 4:20 a.m., five hours after the patient was admitted, an adverse safety event was reported. Patient #10 walked by himself to the restroom and while he walked back to his bed, he became dizzy and fell to the floor. Prior to the fall, there was no evidence Patient #10 had been placed on fall precautions.

B. Interviews were conducted.

a. Leadership interviews revealed a lack of facility oversight and analysis of adverse safety events and the implementation of interventions to prevent reoccurrence.

i. On 7/27/21 at 2:34 p.m., Chief Executive Officer (CEO) #13 was interviewed. CEO #13 stated she and the Risk Manager were responsible for the QAPI plan at the facility. She stated the Risk Manager compiled and assessed the data provided from each patient care department and determined the performance indicators for the QAPI plan. CEO # 13 stated she oversaw the work performed by the Risk Management. She stated she was responsible for reviewing the data provided from the patient care departments after the Risk Manager assessed and analyzed the information. CEO # 13 acknowledged she and the Risk Manager did not accurately identify process gaps and patient service gaps to be tracked and trended for the QAPI Plan for 2021.

CEO # 13 stated the QAPI Plan for 2021 did not indicate individualized quality and performance indicators for the facility. CEO #13 stated.

CEO #13 confirmed adverse safety events reported by staff had not been evaluated, analyzed, investigated, tracked, trended, by herself or other administrative staff. She stated adverse safety events should have been used to identify process improvement needs within the facility. CEO #13 confirmed data related to process improvements had not been generated or assessed. Subsequently, individualized process improvements had not been implemented throughout the facility.

CEO #13 confirmed the QAPI Plan for 2021 was approved and signed on 3/1/21. CEO #13 stated the signed QAPI Plan for 2021 had not been evaluated, reviewed or discussed by the Governing Board, the President of the Medical Staff or herself.

CEO #13 stated patients were at risk for physical harm and death when adverse safety events occurred and were not investigated.

CEO #13's interview was in contrast to the Occurrence Reporting policy which read, adverse safety events were investigated and reviewed when occurrence reports were completed. Occurrence investigation results were reviewed by Medical Staff, the Safety Committee, the Quality Assurance Committee and the Board of Directors. Medical record reviews and root analysis were performed by the CEO, Risk Management, the Quality Assurance Committee and the Safety Committee.

ii. On 7/27/21 at 4:36 p.m., Chief Nursing Officer (CNO) #14 was interviewed. CNO #14 stated she participated in adverse safety event reviews and monitoring. CNO #14 stated she performed follow-up with nursing staff after adverse safety event reviews were performed. CNO #14 stated she discussed and reviewed nursing processes related to adverse safety events during nursing staff meetings. CNO #14 stated patient care processes were not reviewed or changed when adverse patient events occurred. CNO #14 stated nursing staff did not receive further follow up training or competency reviews related to adverse safety events. Furthermore, she stated adverse safety events were not investigated.

CNO #14 acknowledged adverse safety events were not investigated for Patient #7 and Patient #18. Furthermore, she confirmed the adverse safety event involving Patient #18 could have been avoided had an adverse safety event investigation occurred for Patient #7. CNO #14 stated the lack of investigation for adverse safety events resulted in potential harm to patients.

CNO #14 was not able to provide evidence that performance indicators had been tracked, trended, audited, reviewed or evaluated for nursing services. CNO #14 stated the performance indicators for nursing services were not identified based on individualized facility needs or processes.

CNO #14's interview was again in contrast to facility policies.

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §485.645 Special Requirements for CAH Providers of Long-Term Care Services ("Swing-Beds") was out of compliance.

C-1612 Freedom from abuse, neglect, and exploitation. The resident has the right to be free from abuse, neglect, misappropriation of resident property, and exploitation as defined in this subpart. This includes but is not limited to freedom from corporal punishment, involuntary seclusion and any physical or chemical restraint not required to treat the resident's medical symptoms.(a) The facility must-(1) Not use verbal, mental, sexual, or physical abuse, corporal punishment, or involuntary seclusion. Based on interviews and document review, the facility failed to ensure a safe patient care environment. Specifically, the facility failed to monitor the physical safety of a restrained patient in order to prevent physical injury while restrained. Additionally, the facility failed to ensure appropriate restraint use occurred and a physician order for restraint was obtained for each restraint episode for one of one restraint records reviewed (Patient #8). (Cross-Reference C0332)

Based on interviews and document review, the facility failed to ensure a safe patient care environment. Specifically, the facility failed to monitor the physical safety of a restrained patient in order to prevent physical injury while restrained. Additionally, the facility failed to ensure appropriate restraint use occurred and a physician order for restraint was obtained for each restraint episode for one of one restraint records reviewed (Patient #8).

Findings include:

Facility policy:

The Restraint policy defined a restraint as a physical or mechanical device, material or piece of equipment which immobilized or reduced the ability to move the body freely. The following are considered restraints: Therapeutic hold/physical hold to restrict patient movement, intentional administration of non-standard medication doses to manage patient behavior and the raising of all bed rails to restrict movement and/or exit from the bed. Furthermore, a bed rail restraint is defined as a physical restraint in which bed rails on a patient bed are raised and locked on all sides. Bed rail restraints restrict the patient from freely exiting the bed.

A written order for restraint must be obtained from the attending physician responsible for the patient's care. Restraint orders will not be written as a standing or as needed (PRN) order. However, patient placement in restraints may be initiated before a written order has been obtained. Placement in restraint will occur if patient safety, staff safety or the safety of others are in jeopardy. Restraint use will be discontinued at the earliest possible time, regardless of the length of time indicated in the restraint order.

The physician must perform a face to face assessment with the patient within one hour of when the restraint was implemented. The face to face assessment will evaluate patient behavior and well-being. Patients placed in restraint who exhibit violent or self-destructive behavior must be seen and assessed by the attending physician every 24 hours. To continue restraint use, the physician must see the patient every 24 hours and subsequently provide a new written order for restraint.

Restraint monitoring is defined as the observation and documentation of patient care, specifically associated with patient safety, comfort and dignity. Restraint monitoring should occur every 15 minutes (four times every hour). The registered nurse (RN) and/or trained staff will perform patient monitoring. Restraint monitors will observe patient safety, rights and dignity. Restraint monitors will be performed until the patient has been released from the restraint.

Restraint assessments are defined as evaluation of the patient and the patient's response to restraint use and intervention. Restraint assessments will review patient hygiene, vital signs, skin integrity, need for range of motion and circulation exercises and readiness for restraint release. Assessments will be performed, reviewed and evaluated by the RN caring for the patient. The RN will observe and assess restrained patients every two hours until the patient has been released from the restraint. Patients will be continually assessed while restrained to ensure patient rights, privacy, self-respect and well-being are maintained.

Staff are to use and complete the restraint tracking form to document monitoring, assessment, discontinuation and patient status while restrained. Restraint tracking forms, medical records and adverse safety events will be reviewed for safety and risk for patient harm. The facility will assess and evaluate restraint usage for process improvement areas.

Staff are to use and complete the restraint tracking form to document monitoring, assessment, discontinuation and patient status while restrained. Restraint tracking forms, medical records and adverse safety events will be reviewed for safety and risk for patient harm. The facility will assess and evaluate restraint usage for process improvement areas.

1. The facility failed to ensure a physician ordered each episode when a patient was restrained. Additionally, nursing staff failed to monitor the condition and physical safety of a restrained patient to prevent injury while restrained (Patient #8).

A. Documents were reviewed.

a. According to the Restraint policy, the physician responsible for the patient's care must provide a written order for the restraint. The physician must perform a face to face assessment with the patient within one hour of when the restraint was implemented. Physical restraint may be initiated prior to obtaining a written order from the physician when warranted. Continued restraint use required the physician to provide a new restraint order and a face to face assessment with the patient every 24 hours.

A restrained patient will be monitored by a registered nurse (RN) and/or trained staff. Patient safety, patient rights and patient dignity will be monitored at 15 minute intervals (four times every hour). The RN will perform restraint assessment every two hours or sooner to review and evaluate patient vital signs, patient hygiene, skin integrity, the need for range of motion and circulation exercises and restraint release readiness. The attending physician must physically assess the patient every 24 hours while restrained.

b. Nursing notes, physician progress notes and physician orders were reviewed for Patient #8.

i. On 11/19/20 at 8:20 p.m., RN #4 documented in a Nursing Note, Patient #8 was confused, disoriented and attempted to get out of bed. She documented the bed alarm (a device used to prevent falls) on the bed was set to beep when Patient #8 tried to get out of bed.

At 8:34 p.m., Patient #8 exhibited increased confusion and repeatedly tried to exit the bed. RN #4 documented in a Nursing Note all bed rails on the Patient #8's bed was raised and locked and the bed alarm was set to beep to maintain patient safety.

The Restraint policy defined bed rail restraints as all bed rails raised upright and locked in order to impede and restrict the patient's movement and ability to freely exit the bed.

ii. Patient #8 was hospitalized from 11/19/20 through 12/3/20, a total of 15 days. Subsequent medical record review revealed numerous documentation from RNs which showed Patient #8 remained physically restrained for the entire duration of his hospitalization.

Prior to Patient #8's discharge on 12/3/20, there was no evidence in the medical record a physician wrote an initial restraint order, restraint renewal orders or performed face to face assessments for Patient #8.

This was in contrast with the facility policy which stated bed rail restraints were a physical restraint and required a written physician order. For continued restraint use, a new restraint order from the physician was required. Consequently, there was no evidence a physician performed a face to face assessment on Patient #8 while he was restrained with the use of four bed rails.

c. Medical record review for 11/30/20 revealed Patient #8 was involved in an adverse safety event which resulted in physical injury to the patient.

i. On 11/30/20 at 7:30 p.m., Nursing Note documentation revealed Patient #8 sustained a physical injury while in bed rail restraints. At the time of the injury Patient #8 had been physically restrained for 11 consecutive days.

The bed alarm set for Patient #8 sounded. RN #5 entered Patient #8's room and discovered his left leg was caught in the bed rail. Patient #8's left leg was internally rotated (the knee and foot were twisted inward) in an abnormal manner.

At 7:35 p.m., Patient #8's physician ordered a pelvic x-ray (a test that produced an image of the bones of the pelvis and hips). The pelvic x-ray determined Patient #8's left was dislocated from his hip joint (the bone in the upper leg separated from the hip bone). Patient #8's physician documented in a Physician Progress Note, Patient #8's left leg needed to be relocated (placed back into the hip joint). Patient #8 was placed under conscious sedation (a type of sedation where the patient remains awake and aware during a procedure) for the procedure.

Prior to Patient #8 being physically injured on 11/30/20, there was no evidence nursing staff monitored patient safety, patient rights and patient dignity every 15 minutes while the patient was restrained. Additionally, there was no evidence nursing staff performed restraint assessments for the patient.

This was in contrast with facility policy which stated restrained patients would be monitored every 15 minutes by nursing staff to ensure patient rights, privacy, dignity, self-respect and well-being were maintained. Furthermore, nursing staff would assess patient vital signs, patient hygiene, skin integrity, patient safety and the patient's readiness for restraint release to prevent physical injury from occurring while patients are restrained.

B. Interviews were conducted.

a. Interviews with staff revealed nursing staff were required to perform a restraint monitor every 15 minutes and perform a restraint assessment every two hours for restrained patients. Additionally, the patient's physician was required to perform a face to face assessment with the patient within one hour of when the restraint was initiated, once every 24 hours thereafter and before writing a new restraint order.

b. On 7/22/21 at 9:45 a.m., an interview was conducted with Registered Nurse (RN) #4. RN #4 stated she provided care for Patient #8. RN #4 stated she placed all four bed rails upright in a locked position on 11/20/20 while she cared for Patient #8.

She stated raising and locking all four bed rails on a patient's bed was considered a physical restraint. RN #4 stated physical restraints required a written order from the patient's physician. RN #4 acknowledged Patient #8 did not have a written order from the Patient #8's physician when the bed rails were raised and locked on Patient #8's bed. She stated she discussed the use of bed rail restraints for Patient #8 with the patient's physician and advised the physician bed rail restraints were initiated for Patient #8. RN #4 did not recall why she did not document the discussion with the physician or why an order for bed rail restraints was not provided for Patient #8.

RN #4 stated she did not perform restraint monitors or assessments after raising all bed rails on Patient #8's bed. She stated she knew restrained patients were monitored every 15 minutes and documentation was required, but she was unsure what needed to be monitored and documented for the patient.

i. On 7/22/21 at 10:58 a.m., an interview was conducted with CNO #14. CNO #14 reviewed Patient #8's medical record. CNO #14 stated a bed rail restraint was initiated on 11/20/20 at 10:34 p.m. for Patient #8. CNO #14 stated before Patient #8 was placed in the bed rail restraint, nursing staff should have attempted to de-escalate the patient. CNO #14 stated there was no evidence de-escalation was attempted with the patient prior to being placed in the bed rail restraint. CNO #14 stated a written physician order must be obtained to place patients in restraints and a face to face assessment with the physician was required within one hour of restraint use. She stated subsequent, face to face assessment were required every 24 hours and before a new restraint order was written by the physician.

CNO #14 confirmed there was not a physician order to restrain Patient #8. CNO #14 stated a restraint order should have been written by Patient #8's physician and a new restraint order should have been written every 24-hours Patient #8 continued to remain in bed rail restraints. She stated there was no evidence in the medical record Patient #8's physician performed a face to face assessment with the patient while he was restrained.

CNO #14 stated nursing staff were required to perform restraint monitors and assessments on restrained patients. CNO #14 confirmed there were no restraint monitors or assessments performed for Patient #8 while he was restrained.

ii. On 7/22/21 at 8:17 a.m., an interview was conducted with Physician (Physician) #12. Physician #12 stated Patient #8 was placed in bed rail restraints on 11/19/20. Physician #12 stated when the four bed rails were raised, the bed became a physical restraint for Patient #8. Physician #12 stated before the four bed rails were raised on Patient #8's bed, an order for restraints should have been written by the physician. She stated there were no orders for bed rail restraints written by a physician for Patient #8. Physician #12 stated there were no face to face assessments performed by a physician with the patient while he had been restrained.

Physician #12 stated the physician was required to perform a face to face assessment with the patient within one hour of patient placement in restraint. Additionally, she stated a face to face assessment needed to occur before a restraint order to continue restraints was written by the physician. She stated patients needed to be assessed to determine if restraints were an appropriate intervention.

These interviews were in contrast with the facility policy for Restraints which stated the physician must provide a written order for restraints prior to patient placement in restraint. Furthermore, patients who were restrained must be observed, monitored, assessed and documented by nursing staff. Nursing staff would monitor and assess restrained patients to verify patient rights, privacy, safety, dignity, self-respect and well-being were maintained.