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Due to the manner and degree of the deficient practice, the facility failed to meet the Condition of Participation for Physical Plant and Environment.

Based on observation, interview, and record review, the facility failed to:

- Ensure regular equipment maintenance occurred biennially for an adult Eye-Level Mechanical Beam Physicians Scale, located in the Emergency Department, which was used to calculate high-risk, weight-based, medication dosages. This deficient practice had the potential to affect all patients who required weight-based doses of medication. (See C0914).

- Follow their policy and procedures to ensure the proper temperature control was maintained for their primary medication storage room. This deficient practice had the potential to cause degradation of medications stored over the recommended manufacturers' recommendations for temperature parameters, which had the potential to affect all patients who received those medications. (See C0926).

Based on observation, interview, and record review, the facility failed to ensure regular equipment maintenance occurred biennially for an adult Eye-Level Mechanical Beam Physicians Scale, located in the Emergency Department, which was used to calculate high-risk, weight-based, medication dosages. This deficient practice had the potential to affect all patients who required weight-based doses of medication. Findings include:

During an interview and observation on 8/16/21 at 3:50 p.m., the Detecto Adult Eye-Level Mechanical Beam Scale, located in the bathroom of the ED, had a blue sticker which showed: "Calibrated 5/3/20, due 5/4/21." Staff member E stated that was the only scale used to calculate the adult dosages for weight-based medications in the ED.

During an interview on 8/17/21 at 4:20 p.m., staff member CC stated the scale used by the ED was maintained by the facility's contracted AEM company. He confirmed the blue maintenance sticker was expired and said it appeared the scale had not been calibrated since 5/3/20.

During an interview on 8/18/21 at 12:30 p.m., staff member CC stated he contacted the facility's AEM contracting company who confirmed the scale had not been entered into their system for review.

Review of a letter provided to the facility from the contracted AEM Provider, dated 8/18/21, titled, Maintaining Equipment Processes, showed:

"All contracted customers equipment is downloaded into our computer materials management system (CMMS). Each piece of equipment is assigned and scheduled for the work orders. Schedules are either annual or semi-annual depending on the manufacturer recommendations. Our software will automatically open work orders as they become due. This creates the work order list that our technician refers to while on site for the equipment checks. The Detecto scale that was checked in on 5/04/2020 was not added into our management system and therefore no work order was created for it... "

Based on observation, interview, and record review, the facility failed to follow their policy and procedures to ensure the proper temperature control was maintained for their primary medication storage room. This deficient practice had the potential to cause degradation of medications stored over the recommended manufacturers' recommendations for temperature parameters ¹, which had the potential to affect all patients who received those medications. Findings include:

A review of the facility's policy and procedure titled, Temperature Monitoring: Refrigerator/Freezer/Warmers/Room Temperature, with an effective date of 11/25/20, showed:

"Maintain the necessary temperature within the manufacturer's recommendations or warnings... Temperatures are monitored in accordance with manufacturer and regulatory recommendations... C. Controlled Room Temperature (general medication storage) - a temperature held between... (68 and 77 [degrees Fahrenheit])."

During an observation on 8/16/21 at 12:56 p.m., there was a notable increase in temperature entering the medication room from the nurses' station. On the wall was a commercial thermometer for outside temperature readings. The thermometer on the wall read 82 degrees Fahrenheit. A spot check of the Propofol, which was stored on an open shelf in the medication room, showed the manufacturer's temperature storage recommendation for the medication was not to exceed 77 degrees Fahrenheit ¹.

During an interview on 8/16/21 at 12:56 p.m., staff member E stated they utilized the thermometer on the wall to record the temperature of the medication storage room daily. She stated she was not sure what the maximum limit was for the temperature of the medication storage room but would notify staff member CC if the medication storage room was too warm or too cold. She stated the refrigerators in the medication storage room alarmed if the temperatures were out of the established parameters. She stated however, there was no alarm system for the medication storage room thermometer.

During an interview on 8/17/21 at 8:35 a.m., staff member B stated it was the expectation that all medications and biologicals were stored at the recommended manufactures' temperatures.

During an observation on 8/17/21 at 12:09 p.m., the thermometer on the wall of the medication storage room showed 80 degrees Fahrenheit.

During an interview and observation on 8/18/21 at 4:20 p.m., staff member CC stated the refrigerators in the medication storage room were set up to alarm if the temperature in the refrigerators were out of the established parameters. He said the temperature in the medication room was not monitored like the medication refrigerators, and he was not sure what the facility's protocol was for established temperature parameters for the medication storage room. During an observation, staff member CC used a thermometer gun to check the room temperature of the medication room, the thermometer read 78 degrees Fahrenheit. He stated if the medication manufacturers recommended a medication to be stored no higher than 77 degrees Fahrenheit, then the medication room was currently too warm.

During an interview on 8/18/21 at 12:30 p.m., staff member CC stated he added an HVAC system and widened the venting in the medication storage room to ensure a climate controlled temperature per the facility's policy. He stated the temperature controls were now set to alarm should they fall outside of the established temperature parameters. He said if that should occur, he would receive an alert on his phone which indicated the temperature in the medication storage room was out of the established parameters.


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During an interview on 8/23/21 at 11:37 a.m., staff member G stated she was aware of the current thermometer that was in the medication storage room. Staff member G stated the thermometer was a topic to "bring up" and have a better system in place for monitoring ambient room temperature. Staff member G stated she would not know if the integrity of the medication had been compromised due to high temperatures. Staff member G stated she would need to get ahold of the manufacturer of the medications stored in the medication room.

¹ Supply and manufacturing. DIPRIVAN® (Propofol) Injectable Emulsion, USP. (2018, August 10). https://diprivan-us.com/supply-and-manufacturing/. "Propofol undergoes oxidative degradation, in the presence of oxygen, and is therefore packaged under nitrogen to eliminate this degradation path. Store between... (40 to 77 [degrees Fahrenheit])..."

Due to the manner and degree of the deficient practice, the facility failed to meet the Condition of Participation for the Provision of Services.

Based on observation, interview, and record review, the facility failed to:

- Ensure all radiological equipment was inspected and periodic maintenance provided per manufacturer guidelines for a Gendex-Del X-ray machine; and failed to ensure clear signage was posted in the X-Ray and CT machine locations, identifying hazardous radiation areas. The accumulative effect of these deficient practices had the potential to affect all patients and staff utilizing the radiological equipment. (See C1030).

- Develop and implement policy and procedures for standing orders utilized by the Emergency Department which included the development, approval, monitoring, evaluation and any updated standing orders; and failed to include the development of protocols that addressed which circumstances to implement the standing orders, and which staff may initiate and implement standing orders. This deficient practice had the potential to affect all patients who received emergency care based on the facility's developed standing orders in the Emergency Department. (See C1049).

Based on observation, interview, and record review, the facility failed to ensure all radiological equipment was inspected and periodic maintenance provided per manufacturer guidelines for a Gendex-Del X-ray machine; and failed to ensure clear signage was posted in the X-Ray and CT machine locations, identifying hazardous radiation areas. The accumulative effect of these deficient practices had the potential to affect all patients and staff utilizing the radiation services. Findings include:

1. Equipment Maintenance

During an observation and interview on 8/17/21 at 5:09 p.m., the Gendex-Del X-ray machine did not have a sticker which documented when the machine's last periodic inspection and maintenance was completed. Staff member BB stated she believed the X-ray machine was checked about one year ago.

A review of the facility's service report for the Gendex-Del X-Ray machine, dated 9/5/19, showed:

- "Periodic Maintenance completed, with inspection of the machine..."

A review of the facility's service report for the Gendex-Del X-Ray machine, dated 6/8/20, showed:

- "Equipment Repair Report for the Gendex-Del X-Ray table not locking intermittently." A review of this service report did not show the X-ray machine itself was inspected or any maintenance provided to the radiological portion of the machine.

The last inspection and preventative maintenance for the Gendex-Del X-ray machine was 9/5/19.

During an interview on 8/18/21 at 12:30 p.m., staff member CC stated the X-Ray equipment should be inspected and periodic maintenance completed annually to ensure the system was operating properly. The last equipment maintenance for the X-ray machine was 6/8/20, with the last inspection and periodic maintenance completed on 9/5/19. Staff member CC stated the X-ray machine was not inspected or periodic maintenance provided this last year because they were planning to have it removed and replaced in July of 2021. He said the current construction plan for this change had been delayed, and it was not completed in July as originally planned. He stated the Gendex-Del X-ray machine would still be used to take X-rays until it could be replaced with the new construction, but he did not know when that would happen.

2. Safety

A request for the facility's policy and procedure for posting signage to identify hazardous radiation areas was not provided by the end of the survey.

During an observation on 8/17/21 at 4:45 p.m., The CT machine was located in a room behind two closed doors. The first door opened into the main corridor of the hospital; the second door opened into the CT exam room. Outside the second door was a light which turned on to indicate "in use." There was no other signage posted on either door to identify a hazardous radiation area.

During an observation on 8/17/21 at 5:09 p.m., the door which entered into the X-Ray room did not have signage to identify a hazardous radiation area.

During an interview on 8/17/21 at 5:09 p.m., staff member BB stated she could not recall ever having signs posted for the radiology rooms to identify hazardous radiation areas for the CT and X-ray machines.

During an interview on 8/18/21 at 4:50 p.m., staff member CC stated the facility did not have signs posted in the radiology department to identify hazardous radiation areas. He stated even before construction started they did not have signs posted. He stated he would be ordering signs for the radiology department.

Based on observation, interview, and record review, the facility failed to develop and implement policy and procedures for standing orders utilized by the Emergency Department which included the development, approval, monitoring, evaluation and any updated standing orders; and failed to include the development of protocols that addressed which circumstances to implement the standing orders, and which staff may initiate and implement standing orders. This deficient practice had the potential to affect all patients who received emergency care based on the facility's developed standing orders in the Emergency Department. Findings include:

During an observation and interview on 8/16/21 at 12:00 p.m., staff member E stated nurses working in the Emergency Department followed an established protocol when preparing certain medications, such as Heparin and Cardizem, for intravenous administration. Staff member E pulled out a white binder which held the referenced protocols. The protocols referenced by staff member E, had a revision date of 6/6/2011, which included the preparation, dosing, admixing with intravenous fluids, and the administration of Heparin and Cardizem.

Review of the facility's Emergency Department Binder with the outlined standing orders included, "Emergency Department Standing Orders for chest pain or Possible Cardiac Complaints, Revised 06/06/2011." This protocol did not include a current review or revision and did not indicate the circumstances these orders should be initiated or by which staff. The referenced standing orders were not developed, approved, reviewed, monitored, evaluated, or updated in accordance with the facility's established policies and procedures.

Review of the facility's Emergency Department Binder the outlined standing orders included, "Cardizem (Diltiazem) Intravenous." The original document was laminated; and hand-written over the top of the original document, were changes to the order which showed, "Mix 125 mg (25 cc) in 100 cc D5W or NS for concentration of 1 mg/cc." After the hand-written corrected notation, was an additional hand-written notation which stated, "100 mg (20 cc)." This protocol did not include a date of the most recent revision or include protocols for which circumstances these orders were to be initiated or by which staff. The referenced standing orders were not developed, approved, reviewed, monitored, evaluated, or updated in accordance with the facility's established policies and procedures.

Review of the facility's Emergency Department Binder, which outlined the facility's protocol for Heparin, with no revision date, showed:

"If baseline lab work is within normal limits, begin heparin bolus and infusion as follows:
- Bolus dose - 80 Units/kg (dose rounded to nearest 100 units)
- Continuous infusion - 15 Units/kg/hr (dose rounded to nearest 100 Units)." A hand-written notation was entered over the laminated document which showed "DVT" with a hand-written arrow pointing at the "Bolus dose." A second hand-written notation was written on the document after the bolus and continuous infusion order, which showed, "60 units/kg, 12 units/kg/hr", with a third hand-written notation, that had an arrow pointing to the hand-written notation, which showed, "AMI [sic]." This protocol did not include a date of the most recent revision or include protocols for which circumstances these orders should be initiated or by which staff. The referenced standing orders were not developed, approved, reviewed, monitored, evaluated, or updated in accordance with the facility's established policies and procedures.

During an interview on 8/16/21 at 3:50 p.m., staff member E stated she believed a former medical director reviewed the standing order protocols for the ED but could not remember the date he would have reviewed those protocols. She stated she was not sure if staff member Y had reviewed any of the ED standing orders or protocols.

During an interview on 8/18/21 at 9:30 a.m., staff member Y stated standing orders were just getting started and should be available in the EHR when approved by the Medical Staff Committee. He stated he was not aware of any standing orders for the ED.

During an interview on 8/18/21 at 11:30 a.m., staff member B stated the facility did not have any established policy or procedures for standing orders/protocols in the ED or a list of facility approved standing orders.

During an interview and record review on 8/18/21 at 11:45 a.m., staff member A shared a document which outlined a list of standing orders which were projected for Medical Staff review; the items listed were for the long-term care side of the hospital, and not for the ED. She stated the previous DNS had been working on developing standing orders, but did not realize that they did not include standing orders for the ED.

A request for the facility's policy and procedure for Standing Orders and a list of facility developed standing orders with the date of approval, evaluation, and updated information was requested on 8/17/21. No documentation was provided by the end of the survey.

Based on observation, interview, and record review, the facility failed to determine that all personnel providing therapy services had the necessary education, experience, training, and documented competencies to provide rehabilitation services for 1 (#3) of 21 sampled patients. This deficient practice had the potential to affect all patients receiving therapy services by that provider. Findings include:

During an observation on 8/17/21 at 10:56 a.m., staff member M was seated in front of resident #3 as he performed leg lifts in a chair, in the physical therapy room. Staff member M provided guidance to resident #3 during the exercises. After the leg lifts were completed, staff member M assisted resident #3 on to a leg strengthening machine to continue his individual session.

A review of the facility's credentialing records showed the facility did not validate staff member M's education, experience, training, and competencies prior to him providing patient care.

During an interview on 8/18/21 at 3:57 p.m., staff member DD stated they had not reviewed staff member M's education, experience, training, or competencies prior to the staff member providing patient care for inpatient and outpatient therapy services.

Due to the manner and degree of the deficient practice, the facility failed to meet the Condition of Participation for Infection Prevention and Control.

Based on observation, interview, and record review, the facility failed to:

- Ensure the individual employed as the Infection Prevention and Control Specialist was qualified through education, training, experience, and/or certification in infection prevention and control practices; and failed to ensure the individual was appointed by the facility's Governing Body based upon the recommendations of its Medical Staff members. This deficient practice had the potential to affect all patients receiving care and staff providing care at the facility. (See C1204).

- Ensure specific tracking and trending of infections were established for the Infection Prevention and Control Program; failed to adhere to proper infection control practices during wound care for 1 (#2) of 21 sampled patients; failed to ensure timely and routine cleaning, disinfection and spore testing of an autoclave sterilizer used to sterilize patient care instruments; failed to establish a clear delineation between the dirty and clean areas for processing instruments sterilized by the autoclave machine; and failed to establish a process for identifying equipment processed by the autoclave sterilizer should the autoclave malfunction or indicate pathogen growth. The accumulative effect of these deficient practices had the potential to affect all the patients admitted to the facility. (See C1208).

- Ensure an individual, qualified through education, training, and/or experience in infectious disease processes and/or antibiotic stewardship, was appointed by the Governing Body as the leader of the antibiotic stewardship program. This deficient practice had the potential to affect all patients receiving care and staff providing care at the facility. (See C1212).

- Ensure a facility-wide antibiotic stewardship program was established, which incorporated all components of the CAH (Critical Access Hospital) responsible for antibiotic use and resistance. This deficient practice had the potential to affect all the patients of the facility (See C1218).

- Ensure an antibiotic stewardship program was established with the documented evidence-based use of antibiotics in all departments and services of the CAH. This deficient practice had the potential to affect all patients of the facility. (See C1219).

- Ensure an antibiotic stewardship program was established which documented any improvement in the proper use of antibiotics. This deficient practice had the potential to affect all patients of the facility. (See C1220).

- Ensure an antibiotic stewardship program was established which adhered to nationally recognized guidelines, including best practices for improving the use of antibiotics. This deficient practice had the potential to affect all patients of the facility. (See C1221).

- Ensure an antibiotic stewardship program was established which reflected the scope and complexity of the CAH's services provided. This deficient practice had the potential to affect all patients of the facility. (See C1223).

- Ensure an antibiotic stewardship program was established with antibiotic use issues in collaboration with the CAH's QAPI leadership. This deficient practice had the potential to affect all patients of the facility. (See C1229).

- Ensure a facility-wide antibiotic stewardship program was established to monitor and improve the use of antibiotics. This deficient practice had the potential to affect all patients of the facility. (See C1244).

- Establish a facility-wide antibiotic stewardship program which documented all antibiotic stewardship program activities. This deficiency had the potential to affect all patients of the facility. (See C1246).

- Establish a facility-wide antibiotic stewardship program which included communication with medical staff, nursing, and pharmacy leadership, as well as the CAH's QAPI program, on antibiotic use issues. This deficient practice had the potential to affect all patients of the facility. (See C1248).

- Establish a facility-wide antibiotic stewardship program; and failed to provide competency-based training and education for the CAH's personnel and staff, on policies, procedures, and guidelines of an antibiotic stewardship program. This deficient practice had the potential to affect all patients of the facility. (See C1250).

Based on interview and record review, the facility failed to ensure the individual employed as the Infection Prevention and Control Specialist was qualified through education, training, experience, and/or certification in infection prevention and control practices; and failed to ensure the individual was appointed by the facility's Governing Body based upon the recommendations of its Medical Staff members. This deficient practice had the potential to affect all patients receiving care and staff providing care at the facility. Findings include:

A review of the facility's Medical Staff Meeting Minutes, dated 8/20/20, showed, "...Administrative Report: [staff member A] reported [staff member C] has accepted the position as Quality Infection control and Compliance..."

A review of the facility's Medical Staff Meeting Minutes, dated 12/10/20, showed, "... Medical staff vote on the acceptance of [staff member C] as the new Coordinator Compliance Quality and Infection Control person. A motion was made and seconded..."

During an interview on 8/18/21 at 3:47 p.m., staff member DD stated the Medical Staff Committee did agree to staff member C as the facility's Infection Control Preventionist. However, a full review of staff member C's education, training, certifications, experience, and references were not reviewed by the Medical Staff for this approval.

Review of the facility's credentialing files for staff member C did not show a review of the staff member's license, certification, education, training, and experience in infection control were completed for the Medical Staff Committee's review and approval.

During an interview on 8/17/21 at 4:18 p.m., staff member C stated she had no infection control training prior to becoming the Infection Preventionist.

During an interview on 8/18/21 at 10:48 a.m., staff member R stated the Governing Body was told who had applied and placed in the position of Quality Compliance for Infection Control. The Governing Body had not looked at training or qualifications.

No information was provided by the end of survey that showed the Governing Body appointed the individual to the position of Infection Preventionist.

Based on observation, interview, and record review, the facility failed to follow their established Infection Prevention and Control Procedures based on national standards for undiagnosed respiratory illness and COVID-19 to prevent the potential spread of COVID-19 during the transport of a nasal swab for 1 (#21) of 21 sampled patients. Findings include:

The facility census on entrance was 17. There were no positive staff or patient cases of COVID-19 identified during the survey.

A review of the facility's policy and procedure titled, Standard Precautions and Personal Protective Equipment for Blood or Body Fluid Exposure, with a revision date of 8/12/21, showed:

"... Procedure: ... C. During the COVID-19 pandemic, additional source control and protective measures are expected. Source control measures include:
8. Specimens should be enclosed in a secured container and then placed in a sealable, plastic bag to prevent contamination of employees during specimen transportation..."

During an observation and interview on 8/17/21 at 3:00 p.m., staff member H stated she had just obtained a COVID-19 nasal swab for patient #21. She stated due to the patient's current symptoms, they had him in isolation, under precautions for COVID-19, until they could rule it out. During the observation, the swab used to obtain the nasal sample for COVID-19 from patient #21, was inserted back into the swab's original paper wrapper. The top of the wood tip of the nasal swab was exposed. A patient label was placed on the outside of the swab's wrapper. The swab was not placed into a biohazard bag. Staff member B offered to transport the swab to the lab for staff member H. Staff member H then handed the sample to staff member B, who took the swab from staff member H without donning gloves or bagging the sample in a biohazard bag. Staff member B then handed the sample back to staff member H and asked her to hold it until she could put on gloves. Staff member B donned gloves and took the sample back and walked down the hall, past the ED, and main hospital entrance, and handed the COVID-19 test swab to staff member AA. Staff member AA was wearing gloves and accepted the sample from staff member B. Staff member AA then placed the sample down on top of laboratory equipment and told staff member B they would run the swab and report the results as soon as possible.

During an interview on 8/17/21 at 4:54 p.m., staff member AA stated when a nasal swab was obtained, to rule out COVID-19 on suspected patients, the swab should be placed in a biohazard bag with a patient label placed on the swab and in the bag. She stated the sample she received for patient #21 was not inside a biohazard bag.

During an interview on 8/17/21 at 5:20 p.m., staff member H stated patient #21's specimen swab for COVID-19 should have been placed in a biohazard bag for transport.

During an interview on 8/17/21 at 5:26 p.m., staff member B stated she did not transport the COVID-19 specimen to the lab appropriately. She stated she should have put the swab into a biohazard bag.

A review of patient #21's test results for SARS CoV-2 Rapid (COVID-19), dated 8/17/21, was negative.

Based on observation, interview, and record review, the facility failed to ensure specific tracking and trending of infections were established for the Infection Prevention and Control Program; failed to adhere to proper infection control practices during wound care for 1 (#2) of 21 sampled patients; failed to ensure timely and routine cleaning, disinfection, and spore testing of an autoclave sterilizer used to sterilize patient care instruments¹; failed to establish a clear delineation between the dirty and clean areas for processing instruments sterilized by the autoclave machine¹; and failed to establish a process for identifying equipment processed by the autoclave sterilizer should the autoclave malfunction or indicate pathogen growth¹. The accumulative effect of these deficient practices had the potential to affect all the patients admitted to the facility. Findings include:

1. Infection Tracking and Trending

During an interview and record review on 8/17/21 at 3:54 p.m., staff member C provided a spreadsheet titled, "Infection Control Log." The Infection Control Log showed no specific trending of infections or tracking of cultures and sensitivity or pathogen discovery. Staff member C stated she was new to the process and was not trending the information in the infection control report at this time.

Review of the facility's policy titled Infection Control Plan of Service, effective 4/15/21, showed:

"Procedure... C. Strategies to Reduce Risk of Healthcare-Associated Infections:
1. Conduct surveillance activities, data collection and trend analysis for establishing the local incidence of healthcare-associated and selected community-associated infections, to identify potential infection risks to patients, employees, and visitors, and to plan prevention and control activities to prevent the spread of infectious diseases and significant organisms..."

2. Wound Care

During an observation on 8/17/21 at 9:15 a.m., staff member I prepared to change patient #2's bandage on her lower left leg. Staff member I placed all the needed supplies on the bed, washed her hands, and donned clean gloves. Staff member I had not placed a barrier to establish a clean field prior to the placement of the supplies on patient #2's bed. Staff member I removed scissors from her scrub pants, did not clean the scissors, and cut the new bandage to be placed on patient #2's left leg.

During an interview on 8/17/21 at 9:22 a.m., staff member I stated patient #2's wound had a previous infection and the patient had received antibiotics for that infection.

During an interview on 8/17/21 at 9:28 a.m., staff member I stated she felt patient #2's bed was a clean surface for which to place wound care supplies. Staff member I stated she did not usually put something down as a clean barrier. Staff member I stated the scissors were not cleaned prior to use for patient #2's bandage.

During an interview on 8/17/21 at 9:30 a.m., staff member B stated the expectation would be to clean the scissors between each use.

Review of the facility's document titled, Equipment Cleaning and Disinfection: Patient Care Equipment, effective 8/12/21, showed:

"...General Considerations: ...C. All shared patient care equipment will be disinfected between uses for every patient..."


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3. Autoclave Sterilizer

A. Delineation Between Clean and Dirty Area for Central Processing/Instrument Tracking for Potential Pathogen Growth

During an observation and interview on 8/16/21 at 12:15 p.m., in a sink in the ED, was a pink basin. The basin was empty of water, and inside the basin were dirty reusable hemostats, forceps, and scissors. Staff member E stated those instruments were used during patient care emergency procedures for wound care or suturing. She stated they most likely would come in contact with patient body fluids and were sterilized using the facility's autoclave. She said they also had a reusable chest tube tray which was also sterilized at the facility. She stated after the items were cleaned with "Empower" cleaning solution in the ER, they were then transported in the pink basin, covered with a paper towel, to the supply room where the autoclave was located. The supply room was down a main hospital corridor, past the main patient receiving and waiting areas, and past the CT imaging department.

During an observation and interview on 8/16/21 at 12:30 p.m., the room with the autoclave was located in a narrow supply room with racks of patient care supplies on one wall. The adjacent wall had cabinets, a counter with a sink in the middle, and an autoclave sterilizer machine to the right of the sink. Staff member E stated the counter space farthest from the door was their "clean area." Then next to the clean area was a sink, and immediately to the right of the sink, was the autoclave. The sink was used to intermittently process instruments. To the right of the autoclave, between the autoclave and the door to the hospital corridor, was a small countertop space, which staff member E stated they used to wrap the sterile instruments. There were no clear or identifiable delineations between the dirty and clean area and there was no area cleared for particulate splash from the sink.

During an interview on 8/16/21 at 12:30 p.m., staff member E stated they did not a have process in place which could track instruments and equipment sterilized in the autoclave, should the autoclave fail the spore testing or malfunction. She stated she would just compare the dates from the hand-written log, and/or the printed "cycle receipt" of the items sterilized and find those items in the ED by comparing the dates. Staff member E stated it would be important to ensure equipment was safely and sanitarily processed to prevent the accidental contamination of the sterile instruments, and to limit any potential pathogen growth.

During an interview and observation on 8/16/21 at 12:30 p.m., staff member C stated the area to the left of the sink would be considered the dirty area, and the area to the right of the sink would be considered the clean area. During the observation, there was no clear delineation marked to identify the separation of the clean from the dirty areas. Staff member C said anyone could come into the supply room for supplies while instruments were being processed/wrapped for sterilization. Staff member C said the facility did not have a process to track the instruments sterilized in the autoclave, or a way to trend any potential infections related to any potential malfunction of the autoclave sterilization process.

B. Cleaning/Disinfecting/Spore Testing of the Autoclave Sterilizer

During an interview on 8/16/21 at 12:30 p.m., staff member E stated she did not recall any training or competencies provided by the facility on the policy or procedures for processing instruments in the autoclave. She stated she was shown by the nurse who trained her how to process equipment and maintain the autoclave. She said she was taught to put a chemical indicator strip with each packaged item sterilized by the autoclave and to run a spore test on every case of instruments they sterilized. Those results would be logged into the, "Hospital Sterilization Spore Screen Test" log. Staff member E stated it was the responsibility of the night nurse(s) to complete the weekly and monthly cleaning and maintenance and run the spore testing of the autoclave.

During an interview and observation on 8/16/21 at 12:30 p.m., staff member C said every package sterilized by the autoclave had a chemical indicator strip placed inside the packaged instruments to determine if the items were sterilized. A spore test should also be completed with each batch of items sterilized. She stated if the autoclave was not being used to sterilize instruments for an extended period of time, spore testing should be completed weekly between sterilization cases. The autoclave should also be cleaned weekly and disinfected monthly and documented when completed. Staff member C said it was important to ensure the proper routine cleaning and disinfection, as well as regular spore testing, were completed to ensure the autoclave worked properly. She said it was important to ensure sterile instruments were properly sterilized to limit any potential pathogen growth, cross-contamination, or incidental infections. Staff member C said the facility did not have a process to track the equipment sterilized in the autoclave, or a way to trend any potential infections related to any potential malfunction of the autoclave sterilization process.

During an interview and record review on 8/16/21 at 12:45 p.m., staff members C and E provided the following document, stating the document was used as their facility's weekly cleaning and monthly disinfection process for their autoclave sterilizer:

"Caring for Your Ultraclave and Autoclave Sterilizer, by Midmark:

- Weekly: 1. Clean external surfaces... 2. Clean internal surfaces: a. Drain water from reservoir using drain tube located on front of unit. b. Clean trays, door gasket, metal surfaces and inside of the chamber with Speed-Clean Sterilization Cleaner and distilled water. Inspect door gasket for damage that could prevent proper sealing. c. Refill reservoir with clean, distilled water. Equipment Alert: Failure to change water promotes growth of algae in reservoir and may cause sterilizer to malfunction.

- Monthly: Equipment Alert: Failure to flush unit with Speed-Clean Sterilizer Cleaner or use of other sterilizer cleaners may cause some components in unit to fail prematurely. 1. Flush System: a. Drain reservoir and fill with clean distilled water. Add Speed-Clean Sterilizer Cleaner to a cool chamber. b. Run one POUCHES cycle... c. Drain reservoir and fill with clean distilled water. d. Rinse... f. Remove door gasket, dam gasket and gasket ring. Clean with Speed-Clean Sterilizer Cleaner and clean, distilled water. A small stiff brush will aid procedure. After cleaning gaskets, inspect for damage, shrinking, or swelling and replace if necessary... g. Remove trays, tray rack, and tray plate. Pressing downward on top band of tray rack, pull upward on end of tray plate and slide assembly out of the chamber. h. Locate chamber filters on bottom and back of chamber. Grasp filter and pull outward while twisting slightly. (If necessary, a pair of pliers may be used). Filter may be cleaned with Speed-Clean Sterilizer Cleaner and clean, distilled water. A small stiff bristle brush or ultrasonic cleaner may be helpful to remove foreign objects from filter surface. NOTE - If cleaning methods do not effectively clean the filter, replacement may be necessary..."

A review of the facility's documents, used to track the cleaning and disinfection of the autoclave machine, showed two sheets, one dated 12/8/19, and the second dated 4/2020. Neither sheet showed the weekly cleaning of the autoclave was completed for those months as follows: "Autoclave: Weekly cleaning Schedule, drain water, clean trays, door gasket, metal surfaces, and refill reservoir."

On the bottom of the forms showed, "Monthly/Periodic cleaning first of each month, and Speed Cleaner." On the sheet dated 12/8/19, the monthly cleaning was completed with the Speed-Clean Cleaner, initialed as completed. On the second sheet, dated 4/2020, the monthly cleaning was completed, but did not indicate if the Speed Clean-Cleaner was used. Additional logs for the weekly and monthly cleaning of the autoclave from 1/2020 to 8/2021 were not provided by the end of the survey.

During an interview on 8/18/21 at 5:00 p.m., staff member B stated she had reviewed the maintenance logs for the autoclave, since January of 2020 to current, and there were no additional cleaning, maintenance, or spore testing logs.

During an interview and record review on 8/16/21 at 12:45 p.m., staff members C and E provided a document titled, "3M Sterilization Assurance: Easy-to-read 3M Comply (SteriGage) Steam chemical Integrator", stating the document was used as their process for using the sterilization chemical indicator strips.

Review of the facility's document, titled, 3M Sterilization Assurance: Easy-to-read 3M Comply (SteriGage) Steam chemical Integrator showed one chemical integrator strip was to be placed with each item that was sterilized in the autoclave machine. The strip indicated if the items were sterilized. If the indicator reads "accepted" the item has been sterilized. If it reads "reject" then the item was not sterilized.

During an interview and record review on 8/16/21 at 12:45 p.m., staff members C and E provided three documents titled, "Biological Indicator Spore Testing Procedure, " "Crosstex, Sporeview 10-Self Contained Biological Indicators for Monitoring Steam," and "Hospital Sterilizer Spore Screen Test," stating the documents were used for the spore testing of the autoclave.

1. Review of the facility's Biological Indicator Spore Testing Procedure, with no date, showed:
- "Biological indicator spore testing is performed quarterly on all research autoclaves used for biological waste, sterilizing glassware or any other research related uses as outlined in the ECU Biological Safety Manual...
- Without biological indicator testing, adequacy/efficacy of the sterilization process cannot be assumed.
- Ampoules containing Bacillus stearothermophilus are used for this testing, due to its resistance to heat, to measure biological performance...
- Make sure you are purchasing Bacillus stearothermophilus biological spore indicators...
- A log should be created and kept by the lab to record the results. This log will be checked during yearly biosafety lab inspections to ensure that this biological indicator testing is being conducted quarterly..."

2. Review of the facility's document titled, Crosstex Sporeview 10-Self Contained Biological Indicators for Monitoring Steam, dated 2017, showed, "The SporView 10 Self-Contained Biological Indicators (SCBIs) for monitoring Steam processes consist of:
- A thermoplastic vial and cap
- A crushable media ampoule which contains modified Trypticase Soy Broth (TSB) with a PH indicator. The modified TSB will transition from the initial purple color to yellow and/or demonstrate turbidity in the presence of bacterial growth.
- An inoculated carrier (disc) of Geobacillus stearothermophilus (Cell Line 7953) with a population level of [10 to the fifth power] (SVT-050) and [10 to the sixth power] (SVT-056)
Intended Use: The SCBIs may be utilized to monitor Steam [sic] sterilization process efficacy in healthcare and industrial applications.
Instructions for Use:
- Exposure: SCBIs may be placed inside representative materials or within the chamber directly...
- Incubation: Place the processed, activated SCBIs and the Positive Control in a vertical position in an incubator at 55 to 60 [degrees Celsius] for a minimum of 10 hours...
- Note: A Chemical Indicator (CI): The chemical indicating strip (along the center of the SCBI label) should transition from blue to brown/black when exposed to a steam process. The CI does not prove efficacy of sterilization; the biological result should be used to gauge efficacy of the sterilization process.
-Monitoring Frequency: For greatest control of sterilized goods it is recommended that one or more SCBIs be included with every load."

3. A review of the facility's document titled, Hospital Sterilizer Spore Screen Test, showed, "Spore Test with EVERY Sterilization, or weekly if not used." The document then had a table for staff to log the results for the following: "Date/Time; List of Items/Basket X, Y, Z; 3 hr [positive or negative]; 5 hr [positive or negative]; 8 hr; 10 hr; Temp[erature]; and Initials."

Written on a sticky note attached to a blank log titled Hospital Sterilizer Spore Screen Test, was a hand-written note, without a date, which showed, "Sterilizer on tray, after sterilized check to see if blue strip on BI changed from blue to brown. BI will be hot - wait 10 min then crush the tube. Place in the incubator at 55-65 [degrees] for 10 hours. Need to check at 3 - 5 - 8 hours. Record results. No color change in purple media indicates proper sterilization [negative sign]. If color turns yellow it indicates [plus sign] positive growth. Need to re-sterilize items."

A review of the facility's logs for the Hospital Sterilizer Spore Screen Testing, showed the following dates that items were sterilized without the required weekly spore testing when the sterilizer was not in use; and the dates the autoclave machine was not cleaned weekly or disinfected monthly between sterilization cases:

- On 1/6/20: an "ER suture set" was processed with the autoclave, with the hourly incubation spore testing completed. The next sterilization case that was processed in the autoclave, occurred 28-days later, on 2/3/20 at 7:15 a.m., for "ER Instrument sets x 6." The hourly incubation spore testing completed during that sterilization case was positive at three and five hours. A notation on the log, dated 2/3/20, showed, "Load Re-ran". The load was processed again on 2/3/20 at 2:30 p.m. There were 28-days, from 1/6/20 to 2/3/20, that the weekly spore testing was not completed while the autoclave was not in use. There was no documentation to show the weekly cleaning or monthly disinfection of the autoclave was completed between these two cases.

- On 2/21/20: an "ER Instrument sets x 2 and single instruments x 4" were processed. The next sterilization case to be processed in the autoclave was on 3/10/20, for "ER instrument sets x," the hourly incubation spore testing was not completed during this sterilization case. There were 17-days between these two sterilization cases without the completion of the weekly spore testing while the autoclave was not being used. The next case that was processed in the autoclave, which completed the spore testing during the sterilization process, was on 3/20/20. That was 28-days, from 2/21/20 to 3/20/20 that the weekly spore testing was not completed for the autoclave while it was not in use. There also was no documentation to support the weekly cleaning or monthly disinfection of the autoclave from 2/21/20 to 3/20/20.

- On 3/20/20: a "clinic suture removal kit" was processed in the autoclave. The next case that was processed in the autoclave was on 4/13/20, for a "clinic suture removal kit." There were 21-days between these two cases, which the weekly spore testing was not completed while the autoclave was not in use. The Autoclave Cleaning Log showed the autoclave had a monthly cleaning on 4/1/20. There was no additional documentation which showed weekly cleaning or monthly disinfection occurred between these two cases.

- On 8/16/20: an "ER instrument set and single instruments x 5," were processed in the autoclave. The next sterilization case was processed on 8/20/20, the description of the item showed, "Clinic." There was no hourly spore testing completed for the case dated 8/20/20. The following sterilization case, processed on 9/2/20, for "clinic x 3/er scissors x 2", did not show the hourly spore testing was completed. The next sterilization case which had the hourly spore testing completed, was on 9/20/20. There were 35-days from 8/16/20 to 9/20/20, that the spore testing was not completed. With a sterilization case processed between 8/16/20 and 9/20/20, that did not have spore testing completed to identify any potential pathogen growth. The was no additional documentation which showed the weekly cleaning or the monthly disinfection off the autoclave was completed between these cases.

- From 9/20/20: The next sterilization case was processed 10/11/20, for "ER instrument sets x 1 and ER instruments." There were 21-days between these two cases without the weekly spore testing when the autoclave was not being used. There was no additional documentation which showed the weekly cleaning or monthly disinfection of the autoclave was completed during this time.

- On 11/8/20: A case was ran for "ER packs." The hourly spore incubation test was not completed for this case. The next sterilization case processed in the autoclave where the spore testing was completed was on 2/6/21. The log showed 90-days, between 11/8/20 to 2/6/21, which the weekly spore testing of the autoclave was not completed when not in use. There was no documentation which showed weekly cleaning or monthly disinfection of the autoclave during that time.

- From 2/6/21 to 3/17/21 a case was processed for "clinic packs." The next case ran by the autoclave was on 4/7/21, for "clinic packs." The hourly spore checks were not completed for the sterilization kit completed on 4/7/21. The weekly spore testing was not completed for the autoclave for 39-days, from 2/6/21 to 3/17/21, while it was not in use. The documentation showed the autoclave had a monthly cleaning on 4/1/21, but there was no weekly cleanings completed during that time.

- On 4/21/21: A case was ran for "ER instrument set and ER instruments x 3." The next case processed in the autoclave was on 6/3/21. The weekly spore testing was not completed between these two cases for 43-days, from 4/21/21 to 6/3/21. There was no documented weekly cleaning or monthly disinfection of the autoclave.

- On 6/13/21: A case was ran for "ER instruments." The next sterilization case processed in the autoclave was on 7/26/21, for a "chest tube set." The hourly spore testing was not completed for this case. A written note showed, "re-done on 8/7/21." The next case completed with the autoclave was on 8/7/21, for a "chest tube tray." The weekly spore testing of the autoclave was not completed for 55-days, from 6/13/21 to 8/7/21. There was no weekly cleaning or monthly disinfections completed of the autoclave.

During an observation on 8/16/21 at 12:46 p.m., the clear plastic tubing which runs the sterile steam from the water source to the sterilizing compartment, had a thick, crusty, white-colored sediment layering the bottom of the tubing where the tube turns upward and into the sterilization chamber.

During an interview on 8/16/21 at 12:46 p.m., staff member C stated sediment build up in the autoclave could grow pathogens. She stated that was why it was important to complete the weekly and monthly cleaning and disinfection of the autoclave machine, and to run spore testing on the machine at least weekly when it was not being used. She stated it was the responsibility of the night shift nurse(s) to complete the regular cleaning and spore testing on the autoclave. She stated she had recently trained staff member Z on that process.

During an interview on 8/17/21 at 6:15 p.m., staff member Z stated he had not completed any weekly cleaning or monthly disinfection of the facility's autoclave or conducted any weekly spore testing of the autoclave when it was not in use since February or March of 2021. He said staff member C sent out an email that they were no longer using the autoclave and using all disposable equipment. Staff member Z said administration staff had made rounds before the email was sent out inquiring what disposable equipment would be needed to replace the equipment sterilized using the autoclave.

A review of an email sent by staff member C, to TWN [sic] Nurses and CNA's, dated 6/13/21, showed, "We are in the process of going to disposable instruments so that we will not have to autoclave anymore. That being said, we do still have to autoclave the items that we do not have disposable. If you would please make a list of the specific instruments that you are autoclaving so we can make sure to order them in disposable. When you autoclave, please put the date on the slip the [sic] prints from the autoclave..."

There were no additional policy or procedures provided by the end of the survey which outlined the facility's processes for sterilization of reusable patient care instruments and equipment.

¹ Centers for Disease Control and Prevention. (2016, September 18). Sterilizing practices. Centers for Disease Control and Prevention. https://www.cdc.gov/infectioncontrol/guidelines/disinfection/sterilization/sterilizing-practices.html.

Based on interview and record review, the facility failed to ensure an individual, qualified through education, training, and/or experience in infectious disease processes and/or antibiotic stewardship, was appointed by the Governing Body as the leader of the antibiotic stewardship program. This deficient practice had the potential to affect all patients receiving care and staff providing care at the facility. Findings include:

During an interview on 8/17/21 at 4:18 p.m., staff member C stated she had no infection control training prior to becoming the Infection Preventionist.

During an interview on 8/18/21 at 10:48 a.m., staff member R stated the Governing Body was told who had applied and placed in the position of Quality Compliance for Infection Control. Staff member R stated the Governing Body had not looked at training or qualifications.

Review of the facility's credentialing files for staff member C did not show a review of the staff member's license, certification, education, training, and experience in infection control were completed for the Medical Staff Committee's review and approval.

Based on interview and record review, the facility failed to ensure a facility-wide antibiotic stewardship program was established, which incorporated all components of the CAH (Critical Access Hospital) responsible for antibiotic use and resistance. This deficient practice had the potential to affect all the patients of the facility. Findings include:

During an interview and record review on 8/17/21 at 3:54 p.m., staff member C provided a spreadsheet titled, Infection Control Log. The "Infection Control Log" showed no specific trending of infections or tracking of cultures and sensitivity testing or pathogen discovery. Staff member C stated she was new to the process and was not trending the information in the infection control report at this time.

A request was made on 8/18/21 at 11:30 a.m. for the facility's antibiotic stewardship policies and procedures. No documentation was received by the end of the survey.

During an interview on 8/18/21 at 12:19 p.m., staff member C stated the facility did not have an antibiotic stewardship program in place at this time. Staff member C stated there were not any policies and procedures for antibiotic stewardship.

Based on interview and record review, the facility failed to ensure an antibiotic stewardship program was established with the documented evidence-based use of antibiotics in all departments and services of the CAH. This deficient practice had the potential to affect all patients of the facility. Findings include:

A request was made on 8/18/21 at 11:30 a.m. for the facility's antibiotic stewardship policies and procedures. No documentation was received by the end of the survey.

During an interview on 8/18/21 at 12:19 p.m., staff member C stated the facility did not have an antibiotic stewardship program in place at this time. Staff member C stated there were not any policies and procedures for antibiotic stewardship.

Based on interview and record review, the facility failed to ensure an antibiotic stewardship program was established which documented any improvement in the proper use of antibiotics. This deficient practice had the potential to affect all patients of the facility. Findings include:

A request was made on 8/18/21 at 11:30 a.m. for the facility's antibiotic stewardship policies and procedures. No documentation was received by the end of the survey.

During an interview on 8/18/21 at 12:19 p.m., staff member C stated the facility did not have an antibiotic stewardship program in place at this time. Staff member C stated there were not any policies and procedures for antibiotic stewardship.

No system was in place that tracked antibiotic use, culture and sensitivity information, or pathogen discovery.

Based on interview and record review, the facility failed to ensure an antibiotic stewardship program was established which adhered to nationally recognized guidelines, including best practices for improving the use of antibiotics. This deficient practice had the potential to affect all patients of the facility. Findings include:

A request was made on 8/18/21 at 11:30 a.m. for the facility's antibiotic stewardship policies and procedures. No documentation was received by the end of the survey.

During an interview on 8/18/21 at 12:19 p.m., staff member C stated the facility did not have an antibiotic stewardship program in place at this time. Staff member C stated there were not any policies and procedures for antibiotic stewardship.

Based on interview and record review, the facility failed to ensure an antibiotic stewardship program was established which reflected the scope and complexity of the CAH's services provided. This deficient practice had the potential to affect all patients of the facility. Findings include:

A request was made on 8/18/21 at 11:30 a.m. for the facility's antibiotic stewardship policies and procedures. No documentation was provided by the end of the survey.

During an interview on 8/18/21 at 12:19 p.m., staff member C stated the facility did not have an antibiotic stewardship program in place at this time. Staff member C stated there were not any policies and procedures for antibiotic stewardship.

Based on interview and record review, the facility failed to ensure an antibiotic stewardship program was established with antibiotic use issues in collaboration with the CAH's QAPI leadership. This deficient practice had the potential to affect all patients of the facility. Findings include:

A request was made on 8/18/21 at 11:30 a.m. for the facility's antibiotic stewardship policies and procedures. No documentation was provided by the end of the survey.

During an interview on 8/18/21 at 12:19 p.m., staff member C stated the facility did not have an antibiotic stewardship program in place at this time.

Review of the facility's Quality and Safety Committee minutes from 4/15/21, showed infection numbers were reported for the 1st Quarter of 2021. The information reported was broken down by infection type and location within the facility. No documentation was reported related to antibiotic use, culture and sensitivity testing, or pathogen discovery.

Based on interview and record review, the facility failed to ensure a facility-wide antibiotic stewardship program was established to monitor and improve the use of antibiotics. This deficient practice had the potential to affect all patients of the facility. Findings include:

A request was made on 8/18/21 at 11:30 a.m. for the facility's antibiotic stewardship policies and procedures. No documentation was provided by the end of the survey.

During an interview on 8/18/21 at 12:19 p.m., staff member C stated the facility did not have an antibiotic stewardship program in place at this time. Staff member C stated there were not any policies and procedures for antibiotic stewardship.

Based on interview and record review, the facility failed to establish a facility-wide antibiotic stewardship program which documented all antibiotic stewardship program activities. This deficiency had the potential to affect all patients of the facility. Findings include:

During an interview on 8/17/21 at 3:54 p.m., staff member C stated she was not tracking infections and the process was new to her. Staff member C stated she was not trending infections, but knew catheters were a factor.

A request was made on 8/18/21 at 11:30 a.m. for the facility's antibiotic stewardship policies and procedures. No documentation was provided by the end of the survey.

During an interview on 8/18/21 at 12:19 p.m., staff member C stated the facility did not have an antibiotic stewardship program in place at this time.

Review of the facility document titled, "Infection Control Log," showed infections were documented for individual patients, their location within the facility, the antibiotics used, and infections diagnosed. No information was documented in regards to any cultures and sensitivity testing or pathogen discovery. No policies or procedures were in place to guide the documentation.

Based on interview and record review, the facility failed to establish a facility-wide antibiotic stewardship program which included communication with medical staff, nursing, and pharmacy leadership, as well as the CAH's QAPI program, on antibiotic use issues. This deficient practice had the potential to affect all patients of the facility. Findings include:

A request was made on 8/18/21 at 11:30 a.m. for the facility's antibiotic stewardship policies and procedures. No documentation was provided by the end of the survey.

During an interview on 8/18/21 at 12:19 p.m., staff member C stated the facility did not have an antibiotic stewardship program in place at this time.

Review of the facility's Pharmacy and Therapeutic Committee minutes, from 1/1/21 thru 8/19/21, showed no documentation related to an antibiotic stewardship program or any reporting, tracking/trending of antibiotic use.

Review of the facility's Quality and Safety Committee minutes, from 4/15/21, showed infection numbers were reported for the 1st Quarter of 2021. The information reported was broken down by infection type and location within the facility. No documentation was reported related to the antibiotic use, cultures and sensitivity testing, or pathogen discovery.

Based on interview and record review, the facility failed to establish a facility-wide antibiotic stewardship program; and failed to provide competency-based training and education for the CAH's personnel and staff, on policies, procedures, and guidelines of an antibiotic stewardship program. This deficient practice had the potential to affect all patients of the facility. Findings include:

A request was made on 8/18/21 at 11:30 a.m. for the facility's antibiotic stewardship policies and procedures. No documentation was provided by the end of the survey.

During an interview on 8/18/21 at 12:19 p.m., staff member C stated the facility did not have an antibiotic stewardship program in place at this time. Staff member C stated there were not any policies and procedures for antibiotic stewardship.

Review of the facility's document titled, Infection Control Log, showed no documentation of cultures and sensitivity testing or pathogen discovery related to antibiotic use.

Review of the facility's personnel files, did not show facility staff received competency-based training and education on the facility's policies and procedures related to antibiotic stewardship.