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Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §485.618 Condition of Participation: Emergency services, was out of compliance.

C-0888 LIFE-SAVING EQUIPMENT AND SUPPLIES [Equipment, supplies, and medication used in treating emergency cases are kept at the CAH and are readily available for treating emergency cases. The items available must include the following:](2) Equipment and supplies commonly used in life-saving procedures, including airways, endotracheal tubes, ambu bag/valve/mask, oxygen, tourniquets, immobilization devices, nasogastric tubes, splints, IV therapy supplies, suction machine, defibrillator, cardiac monitor, chest tubes, and indwelling urinary catheters. Based on observations, document review and interviews the facility failed to ensure medical supplies and medications were available in emergency situations. Specifically, the facility failed to ensure expired emergency equipment and medications were removed and replaced to provide usable equipment in an emergency situation in one of two emergency patient bays, two of two code carts (carts stocked with emergency medications and supplies) and three of three storage areas observed (operating room (OR) storage area, pharmacy and medication room).

Based on observations, document review and interviews the facility failed to ensure medical supplies and medications were available in emergency situations. Specifically, the facility failed to ensure expired emergency equipment and medications were removed and replaced to provide usable equipment in an emergency situation in one of two emergency patient bays, two of two code carts (carts stocked with emergency medications and supplies) and three of three storage areas observed (operating room (OR) storage area, pharmacy and medication room).

Findings include:

Facility policy:

The Equipment and Supplies policy read, All activity equipment is to be clean, well maintained, and stored properly. The pharmacist shall check the drug storage areas monthly to ensure that no outdated, discontinued or poorly labeled drugs are on hand.

References:

The IFU for Red Dot Electrodes (used for cardiac monitoring) read, for shelf life, refer to the expiration date that is printed on each package.

The IFU for Contour Control Solutions (a solution used to calibrate a blood sugar device) read, Contour test solutions are aqueous glucose solutions intended for use in self-testing by people with diabetes and by health care professionals as a quality control check. It is important to not use the control if the expiration date printed on the bottle label and carton has passed or it has been six months since you first opened the bottle. It will help to write the six month discard date on the label in the area provided when you first open the control. Important: Always check the expiration and discard dates before testing.

1. The facility failed to ensure medications and supplies used in emergencies were ready for use in patients and were not beyond their expiration dates.

A. Observations

i. On 10/24/22 at 12:18 p.m., an observation of a code cart in the operating room storage area revealed one package of 50 Red Dot Electrodes expired 2/17/22, five Red Dot electrodes in an open package expired 2/17/22, and one supraglottic airway resuscitation (an airway device) expired 8/2022.

ii. On 10/24/22 at 12:18 p.m., an observation of the operating room storage area revealed one Rapid Rhino (a device used to treat nosebleeds) 5.5 cm Anterior expired 10/23/22, one Rhino Rocket Slimline (medium) expired 9/19/22, one 20 gauge shielded intravenous (IV) catheter expired 8/31/22, one Arrow Endurance extended dwell peripheral catheter system (used for IV therapy) expired 5/31/2021.

In addition, observation of the operating room storage area revealed one single use 0.9% sodium chloride injection, sterile for injection (10 ml single use) stored without its protective packaging.

iii. On 10/25/22 at 10:01 a.m., observations of the emergency department trauma room (Room #1) revealed an opened Yankauer suction instrument (an oral suctioning tool) with ten foot tubing attached to a suction machine.

Review of the packaging for the Yankauer and suction tubing revealed they were intended for single-use and sterile unless opened.

iv. On 10/24/22 at 2:00 p.m., observation of the medication room revealed blood glucose control solutions, low control solution and high control solution. Both the high control and the low control bottles were opened but were not labeled with the date they were opened.

This was in contrast with the IFU for the control solution which instructed not to use the control if the expiration date printed on the bottle label and carton had passed or it had been six months since the bottle was first opened. Always check the expiration and discard dates before testing.

B. Interviews

i. On 10/24/22 at 1:40 p.m., an interview was conducted with registered nurse (RN) #6. RN #6 stated nurses were given reminders monthly to check all supplies for expiration dates. RN #6 stated expired medications were not to be used because the medication might not have the same effectiveness if used past the expiration date. RN #6 further stated supplies might not be sterile or possibly malfunction when used after expiration date. RN #6 stated if a medication or sterile medical supply was opened and was used, there was a possibility of infection risk to the patient and may lead to hospital associated infection.

ii. On 10/26/22 at 1:28 p.m., an interview was conducted with pharmacy technician (Tech) #7. Tech #7 stated he completed audits for medication expiration dates monthly in the pharmacy, the crash carts, and the medication dispenser in the nurses station. Tech #7 stated the risk to the patient if expired medications were used was the possibility of life-threatening adverse reactions and the medication may not be as effective in treatment.

iii. On 10/26/22 at 3:06 p.m., an interview was conducted with supply technician (Tech) #8. Tech #8 stated she was responsible for the ordering of medical supplies for the hospital, emergency department, and central storage room. Tech #8 stated she checked supplies in the facility monthly in all areas. Tech #8 stated the importance of checking medical supplies for expiration dates was an expired supply might not work the way it was supposed to if used, posing a risk to the patient.

iv. On 10/26/22 at 3:15 p.m., an interview was conducted with RN #9. RN #9 stated a single use medical supply was a supply used for only one patient. RN #9 stated the importance of using a single use supply on one patient was to avoid spreading germs or disease. RN #9 stated if a single use supply was found opened the supply was to be thrown away and staff were expected to get a new medical supply to avoid risk of spreading pathogens to the patient. RN #9 stated the importance of using a single use supply on one patient was to avoid spreading germs or disease.

RN #9 stated controls for the blood glucose machine were expected to have the date they were opened written on the bottles because there was a risk of an inaccurate blood glucose level on a patient if the control solutions were expired. RN #9 stated if a blood glucose level was too low on a patient, there was an increased risk of the patient experiencing a negative outcome, such as becoming unconscious.

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §485.623 Condition of Participation: Physical Plant and Environment, was out of compliance.

C-0914 Maintenance: The CAH has housekeeping and preventive maintenance programs to ensure that-- (1) All essential mechanical, electrical, and patient-care equipment is maintained in safe operating condition. Based on observations, document review, and interviews, the facility failed to ensure essential equipment was maintained in safe operating condition in one of one observations conducted in the laundry processing area.

C-0924 The premises are clean and orderly. Based on observations, interviews and document review, the facility failed to ensure expired cleaning supplies were removed and replaced to provide usable cleaning solutions in one of one cleaning supply storage area observed.

Based on observations, document review, and interviews, the facility failed to ensure essential equipment was maintained in safe operating condition in one of one observations conducted in the laundry processing area.

Findings include:

Facility policy:

The Dryer policy read, manuals should be kept in the desk on operating and maintenance of the machines.

1. The facility failed to ensure preventative maintenance was completed on the washing machine and dryer used to launder patient linens.

a. On 10/24/22 at 12:08 p.m., an observation was conducted in the facility's laundry room. There were no preventative maintenance stickers located on the washing machine and dryer indicating when the last time the machines had preventative maintenance conducted on them.

b. On 10/24/22 at 5:15 p.m., the manufacturer's instructions for use (IFU) for the washing machine and dryer were requested. The facility was unable to provide the IFUs for the washing machine and dryer used to launder patient linens.

This was in contrast to the Dryer policy which read, the manuals on operating and maintenance of the machines would be kept.

c. On 10/26/22, the facility's Large Washing Machine and Dryer policies were reviewed. The policies did not mention how often the machines' preventative maintenance would be completed.

d. On 10/24/22 at 12:08 p.m., an interview was conducted with the director of environmental services (Director) #1. Director #1 stated he was unsure of the exact temperature of the washing machine and there were no temperature gauges on the washing machine or the dryer. Additionally, Director #1 stated the hot water in the washing machine would eradicate bacteria from the linens, but there was no evidence that the water temperature was able to be monitored. Furthermore, Director #1 stated there were no logs kept for preventative maintenance performed on the washing machine or the dryer used to launder patient linens.

e. On 10/26/22 at 12:51 p.m., an interview was conducted with chief financial officer (CFO) #2. CFO #2 stated there was no preventative maintenance process in place for the laundry equipment.

f. On 10/27/22 at 2:26 p.m., an interview was conducted with chief executive officer (CEO) #3. CEO #3 stated it was important to ensure the washing machine and dryer were maintained to ensure sanitary conditions were provided within the facility. Additionally, CEO #3 stated there was a risk for hospital acquired infections and multidrug resistant organisms if the washing machine and dryer did not function properly.

Based on observations, interviews and document review, the facility failed to ensure expired cleaning supplies were removed and replaced to provide usable cleaning solutions in one of one cleaning supply storage area observed.

Findings include:

1. The facility failed to ensure cleaning supplies used in the facility's kitchen area were not beyond their expiration dates.

a. On 10/24/22 at 12:01 p.m., an observation was conducted in the kitchen area of the facility. Under the sink area, cleaning supplies were found to be expired. The expired cleaners included:

i. Oasis Multi-Quat Sanitizer (a sink sanitizer), expired 11/22/19.

ii. EcoLab Wash and Walk floor cleaner (a no rinse floor cleaner) expired 6/2022.

iii. A large glass jar which contained liquid contents and an open plastic bag. The plastic bag read EcoLab Grease Lift (a degreaser) had no expiration date indicated on the bag.

b. Upon request, the facility was not able to provide a policy specific for cleaning supplies.

c. On 10/31/22 at 3:48 p.m., an interview was conducted with the director of environmental services (Director) #1. Director #1 stated anything expired needed to be disposed of. Director #1 stated if an expired cleaning supply was to be used it had the potential to be an infection control risk because it might not have been as effective.

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation ORGANIZATIONAL STRUCTURE was out of compliance.

C-0962 Governing Body or Responsible Individual - The CAH has a governing body or an individual that assumes full legal responsibility for determining, implementing and monitoring policies governing the CAH's total operation and for ensuring that those policies are administered so as to provide quality health care in a safe environment. Based on interviews and document review, the governing body failed to provide oversight. Specifically, the governing body failed to ensure patient care services provided within the hospital were provided in a safe manner and in accordance with professional standards of practice in the areas of quality assurance and performance improvement (QAPI), infection control (IC), nursing services and pharmaceutical services. These failures affected all patients receiving services.

Based on interviews and document review, the governing body failed to provide oversight. Specifically, the governing body failed to ensure patient care services provided within the hospital were provided in a safe manner and in accordance with professional standards of practice in the areas of quality assurance and performance improvement (QAPI), infection control (IC), nursing services and pharmaceutical services. These failures affected all patients receiving services. (C-0335, C-0336, C-1016)

Findings include:

Facility policy:

The Pharmacy Room Policy, read, the pharmacist will conduct monthly inspections of the following areas: medicine room, drug storage room, crash carts, and Emergency Department.

Facility plans:

The Quality Management Plan (QA Plan) signed 12/15/21 read, the Quality Management Plan responds to identified needs within the facility and improves patient-focused systems and processes. The Board of Directors is responsible for the completion and annual review of the Quality Management Plan and will review reports from the Quality Council. The Chief Executive Officer (CEO) and Senior Leadership are responsible for ensuring the Board of Directors is provided with information to evaluate the Quality Management Plan. The Quality Council facilitates and coordinates the Quality Management Plan. The Quality Council meets monthly and reviews policies directly related to the Quality Management Plan. The Quality Council ensures staff compliance with staff training and education. The Quality Management Plan delegates the identification of patient care opportunities and improvements to the nonclinical and clinical staff. The Quality Council will review the Quality Management Plan on an annual basis. The annual appraisal will include an evaluation of the Quality Plan.

The Infection Prevention (IP) Plan (IP Plan), read, the IP nurse conducts continuous monitoring to reduce the risk of healthcare-associated infections in patients and healthcare workers. Risk assessments will be performed with input from nursing, physicians and leadership and the infection prevention nurse will develop and prioritize goals based on the results of the risk assessment. The program will collaborate with clinical services, patient safety and quality improvement to develop protocols for the prevention of hospital-acquired infections. Infection prevention policies and protocols will be developed based on nationally-recognized guidelines and evidence-based practices. Policies are presented to the IP Committee for approval. The IP program will be evaluated for effectiveness annually. The evaluation will be presented to the Quality Committee and Medical Staff Board.

References:

The Hospital Bylaws read, the Governing Body (GB) has oversight over the Quality Management Program. The GB receives and reviews reports pertinent to quality management on a regular basis and identifies performance improvement opportunities. The GB will annually review the effectiveness of the Quality Management Program. The Medical Staff shall conduct a review and appraisal of the quality and utilization of the professional care provided within the facility and report the activities to the GB. The GB will establish rules, regulations and policies determined necessary within the facility.

The Pharmaceutical Scope of Service read, medications are stocked for immediate use by the medical staff in the emergency room. On-going monitoring of drug use through chart review, education, drug usage, evaluation and reporting of significant adverse drug reactions will provide opportunities for hospital administration to continually improve drug use and patient outcomes.

The Organization Chart read, the director of nursing was over the pharmacy and reported to the CEO.

1. The Governing Body (GB) failed to ensure the Quality Management Plan, IP Plan, nursing services and pharmaceutical services were maintained to promote quality healthcare and a safe patient care environment at the facility.

a. A review of the 2021 and 2022 Department Head Meeting Minutes, Medical Staff Meeting Minutes, Quality Council Meeting Minutes, IP Meeting Minutes, and POC (Nursing) Meeting Minutes revealed a lack of governing body oversight.

i. The facility was unable to provide evidence the governing board reviewed and maintained oversight over QAPI program activities, IC program activities, nursing services and pharmaceutical services.

b. The facility was unable to provide evidence the GB reviewed, collaborated and maintained oversight over the QAPI program activities, IC program activities, nursing services and pharmaceutical services.

i. Review of the facility's QA Plan and IP Plan revealed the governing body was expected to provide oversight of the medical operations, the medical director and facility committees. In addition, the GB was expected to provide oversight over medical services, facility operations and the Quality Management Plan. The GB was also expected to delegate reviews and appraisals of the professional care provided within the facility to the Medical Staff who reported the results and activities back to the GB. The CEO was responsible to provide the GB with information pertinent to all departments within the facility. The GB was also responsible for establishing rules, regulations and policies determined necessary within the facility and would evaluate the Quality Management Plan annually. The facility was unable to provide evidence any of the above expectations had occurred.

c. On 10/26/22 at 1:14 p.m., an interview was conducted with CEO #3. CEO #3 stated the governing body had oversight over the following programs and processes: the Quality Management Plan, the IP Plan, Nursing Services and Pharmaceutical services.

CEO #3 stated the facility lacked quality indicators and she was not aware of what was tracked and trended within the facility. She further stated she was unaware of what infection risks had been identified within the IP Plan and she was not aware of any specific surveillance or audits performed for IP. CEO #3 stated she was aware there were process and performance gaps throughout the facility and specifically within the Quality Management Plan, the IP Plan, nursing services and pharmaceutical services.

As a member of the GB, CEO #3's interview was in contrast to the Hospital Bylaws which read, members of the GB were responsible for the management and oversight of all facility programs, policies, processes, rules and regulations. Furthermore, the Bylaws read policies and procedures were established, reviewed and evaluated by the GB on a regular basis to identify performance improvement opportunities throughout the facility.

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 [The policies include the following:] (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 oversight of pharmacy services regarding the implementation of mechanisms to prevent and detect the diversion of controlled substances (medications that may be abused or cause addiction) and to ensure expired medications were not available for use.

Based on observations, interviews, and document review, the facility failed to ensure oversight of pharmacy services regarding the implementation of mechanisms to prevent and detect the diversion of controlled substances (medications that may be abused or cause addiction) and to ensure expired medications were not available for use. (Cross-reference C-0888)

Findings include:

Facility policy:

The Pharmaceutical Scope of Service read, the facility will maintain three medication areas which are under the supervision of a consulting pharmacist: the pharmacy, medication room, and pharmacy clean room. The Pharmaceutical Services Organizational Chart read the director of nursing (DON) reports to the pharmacist.

References:

According to the American Society of Health-System Pharmacists (ASHP)(2022) Guidelines on Preventing Diversion of Controlled Substances, retrieved from: https://www.ashp.org/-/media/assets/policy-guidelines/docs/guidelines/preventing-diversion-of-controlled-substances.ashx, the Guidelines on Preventing Diversion of Controlled Substances read, each organization is responsible for developing a CSDPP (controlled substance diversion prevention program) that complies with applicable federal and state laws and regulations, but also one that applies technology and diligent surveillance to routinely review process compliance and effectiveness, strengthen controls, and seek to proactively prevent or detect diversion. Established policies and procedures address all points of access, reflect a segregation of duties where there are overlapping processes for diversion risk, and ensure that the chain of custody and individual accountability are maintained, documented and verifiable at all times.

The Facility Inspection Report completed and signed on 10/14/22 by Pharmacist #10 read, the controlled medication cabinet is double locked and keys are secure. There are no expired, recalled or deteriorated drugs.

The Organization Chart read, the director of nursing was over the pharmacy and reports to the chief executive officer (CEO).

1. The facility failed to ensure staff access to controlled medications was limited and failed to have processes in place to prevent and detect diversion.

A. Observations

i. On 10/24/22 at 1:46 p.m., an observation was conducted in the pharmacy. The keys to the controlled medications cabinet and the box inside the cabinet that contained controlled medications were kept in an unlocked desk drawer inside the locked pharmacy. DON #4 used the keys from the drawer to unlock the controlled medications cabinet and the controlled medications box located inside the cabinet. Expired controlled medications were stored on a shelf within the cabinet.

During the observation DON #4 stated the pharmacy technician and all nurses had a key to the pharmacy. DON #4 also stated controlled medications inside the pharmacy were accounted for on a monthly basis.

ii. On 10/24/22 at 1:38 p.m., an observation was conducted in the physician dictation alcove. A paper prescription pad with a different facility's name was kept in an unlocked desk drawer. The door to the alcove was not able to close or lock.

iii. On 10/27/22 at 12:16 p.m., a second observation was conducted in the physician dictation alcove. The same paper prescription pad was present in the unlocked desk drawer within the unsecured alcove.

B. Interviews

i. On 10/25/22 at 10:32 a.m., an interview was conducted with registered nurse (RN) #5. RN #5 stated the keys to the pharmacy were handed back and forth between nurses during shift report. RN #5 also stated the keys that allowed access to controlled medications were kept in the top drawer of the desk inside the pharmacy, which was not a locked drawer. Additionally, RN #5 stated wastes of controlled medications were reconciled on a monthly basis.

ii. On 10/25/22 at 2:49 p.m. and 4:15 p.m., interviews were conducted with DON #4. DON #4 stated controlled medication wastes were looked at monthly to verify if the wastes on the medication administration records (MAR) matched what was wasted in the medication dispensing cabinet (Med Dispense). DON #4 also stated there was no formal process in place to verify if the controlled medications that were pulled from the Med Dispense had been documented as being administered to patients. Furthermore, DON #4 stated the facility did not have policies in place that addressed prevention of diversion, and the facility did not follow national guidelines for diversion prevention.

iii. On 10/26/22 at 1:29 p.m., an interview was conducted with pharmacy technician (Tech) #7. Tech #7 stated there were no diversion prevention policies and he was not aware of national guidelines used in the pharmacy for diversion prevention guidance. Tech #7 stated staff used common sense rules when it came to diversion prevention and he did not think nurses would take the medications because the facility had trustworthy staff.

Additionally, Tech #7 stated if staff were untrustworthy, they could take the medications and he was not aware of how the facility dealt with those situations. Tech #7 stated if a nurse took a patient's pain medications, it would be unacceptable from a patient and peer safety standpoint. Tech #7 stated if a nurse took a patient's pain medications, there would be a concern for the patient's pain control. Tech #7 also stated if a nurse took a patient's pain medications, the nurse could be working intoxicated and would be making decisions that they were not in the right mindset to be making.

iv. On 10/27/22 at 9:59 a.m., an interview was conducted with RN #6. RN #6 stated paper prescription pads were held in the Med Dispense and she was not aware that a prescription pad was kept in the desk drawer inside the physician dictation alcove. RN #6 stated the door to the alcove did not lock and it was not an appropriate place for prescription pads to be kept. RN #6 also stated if a prescription pad was stolen, a prescription could be forged for any kind of medication. Additionally, RN #6 stated if someone took a medication they were not familiar with, the medication could damage the body's organs, or the person could overdose and die.

Furthermore, RN #6 stated if a staff member diverted a medication from the pharmacy, controlled medications being accounted for once a month would not be frequent enough to catch the diversion. RN #6 stated if staff diverted medication they were at risk for an overdose and could die.

v. On 10/27/22 at 12:34 p.m., an interview was conducted with consulting pharmacist (Pharmacist) #10. Pharmacist #10 stated she was not aware of the facility's process for reconciling controlled medications. Pharmacist #10 also stated she was unaware of the facility's process for securing paper prescription pads. Additionally, Pharmacist #10 stated if someone were to take a paper prescription pad, they would be able to write prescriptions and divert medications. Furthermore, Pharmacist #10 stated medication diversion put patients and staff at risk for a lethal overdose and death.

Pharmacist #10 then stated she had not seen the key to the locked cabinet inside the pharmacy where the controlled medications were stored.

This was in contrast to the quarterly Facility Inspection Report completed and signed on 10/14/22 by Pharmacist #10 which read, the keys to the controlled medication cabinet were secured.

2. The facility failed to provide oversight of pharmacy services to ensure expired medications were not available for use.

a. On 10/25/22 at 11:03 a.m., an observation was conducted in the pharmacy. Observation revealed expired medications. Examples included:

i. 14 tablets of Lansoprazole (medication used to treat high levels of stomach acid) 15 milligrams (mg), which expired August 2022.

ii. 30 capsules of Emtriva (antiviral medication used to treat Human Immunodeficiency Virus) 200 mg, which expired July 2022.

iii. 3 bottles (2.5 oz each) of Miconazorb AF (antifungal powder medication), which expired July 2022.

iv. 12 tablets of Ibuprofen Junior Strength grape chewables (medication used to treat fever and pain) 100 mg, which expired September 2021.

This was in contrast to the quarterly Facility Inspection Report completed and signed on 10/14/22 by Pharmacist #10 which read, there were no expired or deteriorated drugs.

b. On 10/24/22 at 1:40 p.m., an interview was conducted with RN #6. RN #6 stated staff were expected not to use expired medications. RN #6 also stated expired medications could be less effective or the patient could have a reaction if they were administered.

c. On 10/26/22 at 1:28 p.m., an interview was conducted with Tech #7. Tech #7 stated he completed audits of medication expiration dates monthly in the pharmacy, in the code (emergency) carts, and in the Med Dispense system. Tech #7 stated if an expired medication was used, the patient could have a life-threatening adverse reaction or the medication may not be as effective in treatment. Tech #7 also stated the pharmacist visited on a quarterly basis and there was no one that double checked the tasks he performed.

d. The Pharmaceutical Scope of Service and Pharmaceutical Services Organizational Chart read the pharmacy was under the supervision of a consulting pharmacist and the DON reported to the pharmacist.

This was in contrast to the facility's Organization Chart which read, the DON was over the pharmacy and reported to the CEO.

e. On 10/27/22 at 12:34 p.m., an interview was conducted with Pharmacist #10. Pharmacist #10 stated the consulting pharmacist's responsibilities included reviewing medication orders four times a day, checking medication orders for appropriateness, performing quarterly inspections to verify the facility was in compliance, and was a part of the Pharmacy and Therapeutics Committee which met quarterly.

Upon review of the medical staff meetings, which incorporated the Pharmacy and Therapeutics committee, there was no evidence of discussion of expired medications.

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation PERIODIC EVALUATION AND QUALITY ASSURANCE REVIEW was out of compliance.

C-1302 Quality Assurance - The CAH has an effective quality assurance program to evaluate the quality and appropriateness of the diagnosis and treatment furnished in the CAH and of the treatment outcomes. The program requires that-Based on interviews and document review, the facility failed to ensure the Quality Assessment and Performance Improvement (QAPI) program reviewed and investigated patient safety events to identify causative factors and implement measures to prevent reoccurrence. The failure was identified in two of five adverse safety events reviewed. (Patient #14, and Patient #16)

C-1321 The CAH carries out or arranges for a periodic evaluation of its total program. The evaluation is done at least once a year and includes review of- Based on document review and interviews, the facility failed to ensure Quality Assessment (QA) evaluations were performed annually and the results reflected in the facility's Quality Assessment Performance Improvement (QAPI) plan.

C-0336 §485.641(b) Standard: Quality Assurance The CAH has an effective quality assurance program to evaluate the quality and appropriateness of the diagnosis and treatment furnished in the CAH and of the treatment outcomes.

Based on interviews and document review, the facility failed to ensure the quality assessment and performance improvement (QAPI) program reviewed and investigated patient safety events to identify causative factors and implement measures to prevent reoccurrence. The failure was identified in two of five adverse safety events reviewed. (Patient #14, and Patient #16)

Findings include:

Facility policies:

The Variance Reporting policy read, the facility has a system for reporting and investigating all occurrences which involve patients, personnel, and visitors. All occurrence (adverse safety event) reports are to be placed electronically within the Strategic Quality Support System (SQSS) program. The following are types of occurrences which must be reported: employee injuries, employee illnesses, acts of physical violence, verbal abuse, potential acts of physical abuse or verbal abuse, medication errors, adverse medication effects, falls, equipment failures and malfunctions, and any other concerns or events which would affect the safe operation of the facility. After an occurrence has been submitted the Risk Manager will review, recommend or assign the next steps which include obtaining additional information when needed. Information and analysis of occurrences will be taken to the Safety Meeting. Occurrences involving patients are reported to and reviewed by the Quality Assurance (QA)/Risk Management Committee. Corrective actions will be documented in the occurrence report directly. The Safety Director will review the occurrence reports for trends and submit the reports quarterly to be reviewed by the QA/Risk Management Committee and the Board of Directors.

The Quality Management Plan read, the Quality Management Plan responds to identified needs within the facility and improves patient-focused systems and processes. The Chief Executive Officer (CEO) and Senior Leadership are responsible for ensuring the Board of Directors is provided with information to evaluate the Quality Management Plan. The Quality Council facilitates and coordinates the Quality Management Plan. The Quality Council ensures staff compliance with staff training and education. The Quality Management Plan delegates the identification of patient care opportunities and improvements to the nonclinical and clinical staff.

1. The facility's QAPI program failed to implement performance improvement activities in response to patient safety events.

a. Facility patient safety events were reviewed in conjunction with patient medical records and revealed the QAPI program failed to identify potential quality problems in response to patient safety events and implement corrective action to prevent reoccurrence.

Examples of patient safety events included:

i. On 8/17/22 at 7:36 a.m. Patient #14 was admitted to the facility for dyspnea (difficulty breathing) and anemia (iron deficiency). Eight days later on 8/29/22 at 4:28 p.m., a patient safety event was reported.

A medical record review revealed Patient #14 was administered six units of blood at the facility. Patient #14 was transferred to another facility on 8/19/22 and subsequently died.

A review of the patient safety event revealed the hospital where Patient #14 was transferred communicated to the facility Patient #14's death was potentially related to a blood transfusion reaction. There was no evidence the facility had investigated this possibility. Furthermore, the facility was unable to provide evidence they had conducted an investigation into the patient safety event.

ii. On 6/2/22 at 1:30 p.m., Patient #16 was transported by ambulance to the Emergency Department (ED). Patient #16's chief complaint was left foot pain. Patient #16 had inadvertently crushed the toes on his left foot under a dolly (a device used to move large items). On 6/16/22, 14 days after Patient #16 was seen in the ED, a patient safety event was reported.

Medical record review revealed the radiology report on 6/2/22 stated, the second toe on Patient #16's left foot had been fractured and severely impacted (the ends of the fractured bones become forced into each other), furthermore the toe had been dislocated. According to the History and Physical (H&P) on 6/2/22, the Emergency Department (ED) physician informed Patient #16 his second left toe had a hairline fracture (a small crack within the bone), and no additional treatment was indicated. According to the discharge instructions, Patient #16 was to seek outpatient follow-up for the fracture in two weeks.

Further medical record review revealed on 6/10/22 at 9:16 a.m., Patient #16 informed the facility he was informed during his clinic follow-up visit how extensive the fracture was to his second left toe. Patient #16 consulted an orthopedic specialist to assess his toe and determine the medical treatment needed for proper healing.

A review of the patient safety event for Patient #16 revealed the facility failed to investigate the patient safety event. Additionally, the corrective actions to prevent reoccurrence and patient harm had not been implemented.

The facility was unable to provide evidence the patient safety events for Patient #14 and Patient #16 had been reviewed and investigated. This was in contrast to the Variance Reporting policy which stated, patient safety events were reviewed and investigated by the facility to ensure preventative steps and corrective actions were implemented to prevent reoccurrence.

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

i. On 10/27/22 at 2:00 p.m., an interview was conducted with chief executive officer (CEO) #3. CEO #3 stated she and the director of nursing (DON) #4 oversaw the QAPI program at the facility. CEO #3 stated the facility had not implemented a system to identify process and patient service gaps. CEO #3 further stated patient safety events were not tracked and trended.

CEO #3 stated the facility lacked quality and performance indicators specific to the facility. CEO #3 stated patient safety events had not been analyzed, tracked and trended by herself or other administrative staff. CEO #3 stated quality process improvement goals had not been established at the facility. CEO #3 stated patient safety events should have been analyzed and used to identify process improvement needs within the facility.

CEO #3 stated she did not have evidence patient safety events involving Patient #14 and Patient #16 were investigated. Furthermore. CEO #3 stated patients were at risk for physical harm and death when patient safety events occurred and preventative measures were not implemented to prevent reoccurrence.

ii. On 10/27/22 at 1:50 p.m., DON #4 was interviewed. DON #4 stated she performed follow-ups with nursing staff after patient safety events occurred. DON #4 stated she had not reviewed the patient safety events for Patient #14 and Patient #16. She further said she had not provided nursing education or training for the patient safety events involving Patient #14 and Patient #16. DON #4 stated patient care processes were not reviewed or changed when patient safety events occurred. DON #4 stated nursing staff were not provided additional training or competency evaluations in response to patient safety events. Furthermore, DON #4 stated she did not investigate patient safety events at the facility.

DON #4 stated the lack of patient safety event investigations and implementation of measures to prevent reoccurrence resulted in potential harm to patients. Furthermore, DON #4 stated nursing services had not evaluated patient safety events.

These interviews were in contrast to the Variance Reporting policy which stated patient safety events would be reviewed and corrective actions implemented in order to prevent patient harm and event reoccurrence.

C-0335 §485.641 (a)(2) The purpose of the evaluation is to determine whether the utilization of services was appropriate, the established policies were followed, and any changes are needed.

Based on document review and interviews, the facility failed to ensure Quality Assessment (QA) evaluations were performed annually and the results reflected in the facility's Quality Assessment Performance Improvement (QAPI) plan. (Cross Reference C-0962)

Findings include:

Facility Policy:

The Quality Management Plan read, the Quality Management Plan responds to identified needs within the facility and improves patient-focused systems and processes. The Board of Directors is responsible for the completion and annual review of the Quality Management Plan and will review reports from the Quality Council. The Chief Executive Officer (CEO) and Senior Leadership are responsible for ensuring the Board of Directors is provided with information to evaluate the Quality Management Plan. The Quality Council facilitates and coordinates the Quality Management Plan. The Quality Council meets monthly and reviews policies directly related to the Quality Management Plan. The Quality Council ensures staff compliance with staff training and education. The Quality Management Plan delegates the identification of patient care opportunities and improvements to the nonclinical and clinical staff. The Quality Council will review the Quality Management Plan on an annual basis. The annual appraisal will include an evaluation of the Quality Plan.

1. The facility failed to conduct an annual QA evaluation and implement the results of the evaluation into the QAPI plan. Furthermore, the facility failed to establish performance improvement indicators based on high-risk problem-prone areas.

a. Review of facility documents revealed no evidence the facility had conducted a QA evaluation and established quality improvement indicators based on high-risk problem-prone areas.

This was in contrast to the Quality Management Plan which stated an evaluation would be performed yearly of the facility's quality plan and would identify areas for patient care opportunities and improvements.

i. Upon request, the facility was unable to provide evidence quality improvement projects and activities were based on high-risk, problem-prone areas which affected patient safety and quality of care.

Additionally, no evidence was provided for how the facility tracked performance and process improvements, how the facility determined process improvements were needed and how the facility ensured performance and process improvements were sustained.

b. On 10/27/22 at 12:23 p.m., an interview was conducted with chief executive officer (CEO) #3. CEO #3 stated the facility had not conducted a QA evaluation. She further stated the facility was aware performance improvement indicators had not been established and there was a lack of review, evaluation, investigation and data analysis for patient safety events.

CEO #3 stated the facility had not tracked or trended data to determine high-risk problem-prone areas present within the facility. Furthermore, CEO #3 stated the facility had not established quality indicators reflective of the complexity of services provided at the facility.