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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 §482.42 Infection Prevention and Control and Antibiotic Stewardship Programs was out of compliance.

A-0749 The hospital infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the hospital and between the hospital and other institutions and settings. Based on observations, interviews, and document review the facility failed to employ methods to prevent and control the transmission of infections. Specifically, the facility failed to correctly perform high-level disinfection and decontamination, failed to ensure multidose vials were used in accordance with national standards, and failed to ensure single use items were used with multiple patients in four of four observations of the outpatient clinics.

A-0772 Leadership responsibilities: the infection preventionist(s)/infection control professional(s) is responsible for: The development and implementation of hospital-wide infection surveillance, prevention, and control policies and procedures that adhere to nationally recognized guidelines. Based on document review and interviews, the facility failed to develop and implement surveillance policies and procedures that adhered to facility policy and national guidelines in four of the four outpatient clinics observed.

Based on observations, interviews, and document review the facility failed to employ methods to prevent and control the transmission of infections. Specifically, the facility failed to correctly perform high-level disinfection and decontamination, failed to ensure multidose vials were used in accordance with national standards, and failed to ensure single use items were used with multiple patients in four of four observations of the outpatient clinics.

Findings include:

Facility policies:

According to the facility policy High-Level Disinfection of Endoscopes, Purpose: To prevent cross-contamination of patients when using endoscopes for multiple procedures. Conduct dry leak test of flexible endoscopes prior to immersion. Conduct wet leak tests with scope completely submerged under water. Remove endoscope from service if it leaks before it is cleaned.

According to the facility policy Practices for Sterilization, all BI (Biological Indicator) test results, including results from controls, should be interpreted by qualified personnel in the time frame specified by the BI manufacturer.

According to the facility policy Disinfection of Equipment and Exam Rooms, manufacturer's recommendations will be followed on all disinfectants.

According to the facility policy High Level Disinfection of Instruments, all instruments will be manually washed using an enzyme presoak detergent per the manufacturer's guidelines and then rinsed with water.

According to the facility policy Use of Multiple Dose Vials, use multidose vials for a single patient when medication is prepared at the point of use.

According to the policy Practices for Sterilization, attire, use of personal protective equipment, and limitations in personnel access and movement should be based on expected contamination levels. When performing decontamination expected PPE includes gloves, gown or apron, eye protection, mask or face shield, and head cover.

References:

According to ANSI/AAMI ST79:2017, Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities, the first and most important step in reprocessing reusable medical devices is thorough cleaning and rinsing. Cleaning removes microorganisms and other organic and inorganic materials.

When manually cleaning devices, personnel should wear appropriate personal protective equipment.

Used, soiled, contaminated instruments, devices, and supplies are sources of microorganisms that could cause infections in personnel or patients. All medical devices are considered to be soiled and contaminated after each use and to be potential sources of infection.

Prior to transportation items contaminated with blood and other potentially infectious materials should be placed in a container that is puncture resistant, leak-proof on the bottom and sides, labeled as biohazardous, and sealed.

According to the Centers for Disease Control and Prevention Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 Update: May 2019, flexible endoscopes are particularly difficult to disinfect and easy to damage because of their intricate design and delicate materials. Because of the types of body cavities they enter, flexible endoscopes acquire high levels of microbial contamination (bioburden) during each use. To prevent the spread of healthcare-associated infections, all heat-sensitive endoscopes (e.g. gastrointestinal endoscopes, bronchoscopes, nasopharyngoscopes) must be properly cleaned and, at a minimum, subjected to high-level disinfection after each use. In general, endoscope disinfection or sterilization with a liquid chemical involves five steps after leak testing: Cleaning, disinfecting, rinsing, drying, and storing.

Enzyme solutions should be used in accordance with manufacturer ' s instructions, which include proper dilution of the enzymatic detergent and contact with equipment for the amount of time specified on the label.

Personal protective equipment should be worn when contaminated instruments, equipment, and chemicals are handled.

The delivery of sterile products for use in patient care depends not only on the effectiveness of the sterilization process but also on the unit design, decontamination, disassembling and packaging of the device, loading the sterilizer, monitoring, sterilant quality and quantity, and the appropriateness of the cycle for the load contents, and other aspects of device reprocessing. Healthcare personnel should perform most cleaning, disinfecting, and sterilizing of patient-care supplies in a central processing department in order to more easily control quality. The aim of central processing is the orderly processing of medical and surgical instruments to protect patients from infections while minimizing risks to staff and preserving the value of the items being reprocessed. Healthcare facilities should promote the same level of efficiency and safety in the preparation of supplies in other areas (e.g., operating room, respiratory therapy) as is practiced in central processing.

According to the Centers for Disease Control and Prevention Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 Update: May 2019, in August 2000, FDA released a guidance document on single-use devices reprocessed by third parties or hospitals. In this guidance document, FDA states that hospitals or third-party reprocessors will be considered "manufacturers" and regulated in the same manner. A reused single-use device will have to comply with the same regulatory requirements of the device when it was originally manufactured.

According to the Centers for Disease Control and Prevention online document Injection Safety, retrieved 10/26/22 from https://www.cdc.gov/injectionsafety/pdf/Injection-Safety-For-Healthcare-P.pdf, after the procedure multidose vials should be discarded when doses are drawn in a patient treatment area. Although multidose vials can be used for more than one patient when aseptic technique is followed, ideally even multidose vials are used for only one patient.

According to the directions for the EcoLab Enzymatic Detergent, add 1/2-1 fluid oz per 1 U.S. gallon of warm water.

According to the instructions for use of the circumcision clamp, as part of the steps for sterilization wash the clamp with a cleaning solution to remove any foreign material.

According to the instructions for use for the Storz Cleaning and Sterilization/Disinfection Instructions for 11101 RP2/SK2, before proceeding to manual cleaning, always perform a leak test on the flexible endoscope. Leaking flexible endoscopes must not be used in medical procedures as they pose a patient safety risk.

According to the package for the suction tubing, the tubing is single use only. Do not reuse. Sterile. Do not resterilize.

1. The facility failed to ensure endoscopes were reprocessed in the Ear, Nose, and Throat Clinic according to the manufacturer's instructions for use, facility policy, and national guidelines.

a. On 10/24/22 at 2:17 p.m., observations were conducted in the facility's Ear, Nose, and Throat (ENT) Clinic instrument reprocessing area. These observations revealed a Karl Storz 11101 flexible endoscope (scope) (a medical instrument used to visualize the inside of a patient's throat). Observations did not reveal associated equipment for leak testing (a testing process for the scope during which air is forced through it to verify internal integrity).

i. The Cleaning and Sterilization/Disinfection Instructions for the scope read the use of the leakage tester during high-level disinfection was required to prevent possible damage to the scope. Staff should have attached the leakage tester to the scope, attained a pressure of 200 millimeters of mercury (mmHg) within the scope, fully moved the tip of the scope five times in each direction, then released the pressure to 160 mmHg. While still pressurized, the scope should have then been completely immersed in room-temperature water without detergent. The scope should have remained submerged for one minute while fully moving the tip. If the leakage tester lost pressure, or if staff saw bubbles, the scope should have been immediately removed from the water and returned to the manufacturer for repair.

ii. On 10/24/22 at 2:17 p.m., an interview was conducted with registered nurse (RN) #1. During this interview, RN #1 described the steps she took to manually clean the scope. These steps did not include leak testing the scope.

On 10/25/22 at 10:45 a.m., an interview was conducted with medical assistant (MA) #2. During this interview, MA #2 described the steps she took to manually clean the scope. These steps did not include leak testing the scope. She stated she had not been trained on how to perform leak testing, and therefore was unsure of the purpose of the test.

These interviews were in contrast to the facility policy High-Level Disinfection of Endoscopes, which stated the purpose of high-level disinfection was to prevent cross-contamination between patients. Dry leak testing of flexible endoscopes should have been performed prior to immersion. Wet leak tests should have been conducted with the endoscope completely submerged underwater. A scope should have been removed from service prior to cleaning if a leak was discovered.

The interviews were also in contrast to the Centers for Disease Control and Prevention (CDC) Guideline for Disinfection and Sterilization in Healthcare Facilities, which read leak testing was required prior to cleaning.

iii. On 10/25/22 at 4:04 p.m., an interview was conducted with the director of surgical services (Director) #3. Director #3 stated leak testing ensured there were no holes within the scope. She explained holes in the scope created a risk to patients as the scope could have malfunctioned while it was being used. She additionally explained a damaged scope could not be completely cleaned as body fluids could become lodged inside of it. She said failing to properly test the scope could pass germs to the next patient. Director #3 stated she was unaware that the endoscopes used in the ENT clinic required leak testing.

iv. On 10/25/22 at 4:04 p.m., an interview was conducted with the nurse manager for the clinics (Manager) #4. Manager #4 stated the clinics used CDC national guidelines to direct infection control policies and procedures. She further stated the purpose of following manufacturer's recommendations in reprocessing scopes was to prevent cross-contamination between patients.

b. On 10/24/22 at 2:17 p.m., observations were conducted in the facility's ENT Clinic instrument reprocessing area. Observations revealed a sealed basin, dated within the prior two weeks, of Metricide OPA Plus (Metricide), a disinfectant used for high-level disinfection of medical equipment. A vial labeled Metricide OPA Plus Test Strips (test strips) was stored near the basin.

i. On 10/25/22 at 10:45 a.m., an interview was conducted with MA #2, during which she described how she used the Metricide to perform high-level disinfection of a scope. She demonstrated the use of the test strips and explained she used the strips once daily. She further explained the test strips verified the Metricide was working properly to ensure disinfection of the scope. She said an improperly disinfected scope could cause patient infections.

This interview was in contrast with the label on the Metricide bottle which read the disinfectant could have been stored in a closed container and reused for up to thirty days after opening; however, the directions stated test strips should have been used to verify the efficacy of the disinfectant prior to each cycle of cleaning, not once daily as explained by MA #2.

This interview was also in contrast with the policy Practices for Sterilization, which read all biological indicator test results, including results from controls, should have been interpreted in the time frame specified by the manufacturer.

2. The facility failed to follow national guidelines by allowing unsterilized instruments to remain uncontained in patient care areas in the General Surgery Clinic.

i. On 10/25/22 at 11:56 a.m., observations were conducted in a procedure room in the facility's General Surgery Clinic. During these observations, MA #2 demonstrated how she allowed surgical instruments to dry after the decontamination process. Her procedure was to leave the instruments open to air on a clean, disposable underpad.

MA #2 stated in the instance the instruments were not completely dry prior to the start of the next procedure, she would have folded the underpad over them. She further stated the instruments remained in the procedure room during subsequent procedures. MA #2 said after several procedures, her practice was to place the instruments in a hard-sided biohazard container and transport them to the central processing department for sterilization.

This interview was in contrast to the Centers for Disease Control and Prevention (CDC) Guideline for Disinfection and Sterilization in Healthcare Facilities, which read the delivery of sterile products used in patient care depended on the effectiveness of the sterilization process. Healthcare personnel should have performed most cleaning, disinfecting, and sterilizing of patient-care supplies in a central processing department in order to more easily control quality. The aim of central processing was the orderly processing of medical and surgical instruments to protect patients from infections while minimizing risks to staff and preserving the value of the items being reprocessed. Healthcare facilities should have promoted the same level of efficiency and safety in the preparation of supplies in other areas as was practiced in central processing.

The interview was also in contrast to ANSI/AAMI ST79:2017 (AAMI), Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities, which read used, soiled, contaminated instruments, devices, and supplies were sources of microorganisms that could have caused infections in personnel or patients. All medical devices were considered to be soiled and contaminated after each use and to be potential sources of infection.

The AAMI guideline further read, prior to transportation items contaminated with blood and other potentially infectious materials should have been placed in a container that was puncture resistant, leak-proof on the bottom and sides, labeled as biohazardous, and sealed.

iii. On 10/25/22 at 4:04 p.m., an interview was conducted with the Manager #4. Manager #4 stated the clinics used CDC national guidelines to direct infection control policies and procedures. She further stated the entire procedure room was considered a patient care area.

iv. On 10/25/22 at 4:04 p.m., an interview was conducted with Director #3. Director #3 stated the facility used AAMI guidelines to direct reprocessing and sterilization. Director #3 also stated the purpose of decontaminating surgical instruments was to remove blood. She explained after transportation to the central processing area, staff placed the surgical instruments in a washer that used much hotter water to provide further disinfection. After the washer, staff then repackaged the instruments and placed them in a sterilizer. Instruments were then allowed to fully cool and dry before being moved.

Director #3 explained instruments were not released back to patient care areas until they had fully undergone this process. Director #3 stated surgical instruments left in a patient care area prior to completing the full sterilization process could have increased the risk of infections.

3. The facility failed to ensure enzymatic detergents were used according to the manufacturer's instructions in the Women's Health, Pediatric, ENT, and General Surgery Clinics. Additionally, the facility failed to ensure an enzymatic detergent was used for manual cleaning in the Pediatric Clinic.

a. Observations

i. On 10/24/22 at 1:39 p.m., observations were conducted in the facility's Women's Health Clinic instrument reprocessing area. Observations revealed a bottle of EcoLab Enzymatic Detergent (detergent) capped with a pump on the counter, next to a sink. Observations did not reveal measuring containers for water or for the detergent. There were no markings on the inside of the sink to determine a premeasured amount of water.

ii. On 10/24/22 at 2:00 p.m., observations were conducted in the facility's Pediatric Clinic instrument reprocessing area. There was not a bottle of detergent next to the sink. Observations did not reveal measuring containers for water or for the detergent. There were no markings on the inside of the sink to determine a premeasured amount of water.

iii. On 10/24/22 at 2:08 p.m., observations were conducted in the instrument reprocessing area shared between the facility's ENT and General Surgery Clinics. Observations revealed a bottle of detergent capped with a pump on the counter, next to a sink. Observations did not reveal measuring containers for water or for the detergent. There were no markings on the inside of the sink to determine a premeasured amount of water.

These observations were in contrast to the directions on the detergent, which revealed the manufacturer required 1/2 to one ounce of detergent per gallon of warm water. The directions did not indicate the pump measured the amount of detergent as it was being dispensed.

The observations were also in contrast to the facility policy Disinfection of Equipment and Exam Rooms, which read manufacturer's recommendations should have been followed on all disinfectants.

The observations were also in contrast to Centers for Disease Control and Prevention (CDC) Guideline for Disinfection and Sterilization in Healthcare Facilities, which read enzyme solutions should have been used in accordance with manufacturer's instructions, which included proper dilution of the enzymatic detergent.

b. Interviews

i. On 10/24/22 at 1:44 p.m., an interview was conducted in the Women's Health Clinic with RN #5. RN #5 stated as part of her steps for cleaning instruments after procedures, she filled the sink with one gallon of warm water and added one pump from the bottle of detergent. She indicated an approximated level in the sink for one gallon of water.

ii. On 10/24/22 at 2:00 p.m., an interview was conducted in the facility's Pediatric Clinic with licensed practical nurse (LPN) #6. LPN #6 stated the clinic reprocessed circumcision clamps by performing manual cleaning prior to transporting instruments to the facility's central processing department for sterilization. She stated she began the cleaning process by rinsing the clamps with warm water mixed with a few pumps of hand soap.

This interview was in contrast with the instructions for the circumcision clamp, which read the clamp should have been washed with a cleaning solution to remove any foreign material.

This interview was also in contrast to the policy High Level Disinfection of Instruments, which read all instruments should have been manually washed using an enzyme presoak detergent per the manufacturer's guidelines.

iii. On 10/24/22 at 2:17 p.m., an interview was conducted in the ENT and General Surgery Clinics with RN #1. RN #1 stated the purpose of using the enzymatic detergent was to perform precleaning to remove bioburden (bacteria living on the surface of an instrument).

iv. On 10/24/22 at 2:17 p.m., an interview was conducted in the ENT and General Surgery Clinics with MA #2. MA #2 stated she manually cleaned instruments by filling the sink halfway with water, and then added either a half pump or up to two pumps of detergent. She stated the amount of detergent depended on the amount of soil on the instruments. She further stated she believed staff in the central processing department repeated the process of manually cleaning the instruments with detergent.

MA #2 said detergent was used rather than hand soap as the use of hand soap could not ensure bodily fluids were fully removed from instruments. She stated if bodily fluids were not fully removed it could have caused infection in subsequent patients. MA #2 further explained the use of hand soap could have caused damage to the surgical instruments.

v. On 10/25/22 at 4:04 p.m., an interview was conducted with Manager #4, during which she stated the purpose of enzymatic cleaners was to start the instrument cleaning process so later steps would effectively sterilize the instruments. She explained ratios of detergent to water were important because correct ratios ensured proper cleaning. She further explained if the detergent was too diluted the enzymes in the detergent would not have been effective. She said the risk of using improper ratios of detergent to water was that improperly cleaned instruments and equipment could have transferred diseases and germs between patients.

Manager #4 further stated for manual cleaning processes to have been effective an enzymatic detergent should have been used. She stated hand soap was not an acceptable cleaning agent for instrument processing, and should not have been used as a replacement for the detergent.

vi. On 10/25/22 at 4:04 p.m., an interview was conducted with director of surgical services (Director) #3. Director #3 stated the facility used AAMI guidelines to direct reprocessing and sterilization in the central processing area. She further stated the manual cleaning process done by staff in the clinics was equivalent to the decontamination process used by staff in the central processing area. She explained central processing staff did not repeat the manual cleaning or decontamination steps after receiving instruments from the clinics.

4. The facility failed to follow national guidelines and facility policy when accessing multidose medication vials in patient care areas in the General Surgery Clinic.

i. On 10/25/22 at 11:56 a.m., observations were conducted in a procedure room in the facility's General Surgery Clinic. Observations revealed a multidose vial (MDV) of Lidocaine with epinephrine (a medication injected into the skin layers for local anesthesia, with an additional medication that decreased bleeding). The vial was located on a counter in the procedure room, and was unlabeled. The MDV had been opened.

ii. On 10/25/22 at 11:56 a.m., an interview was conducted in the procedure room with MA #2. MA #2 stated the MDV had been opened during a procedure that had just taken place, while the patient was in the room. She then demonstrated how she labeled the vial and placed it back in a storage cabinet. She stated the medication would be used again during the next procedure.

This interview was in contrast to the CDC's document Injection Safety, which read after procedures MDVs should have been discarded when doses were drawn in a patient treatment area. The document further read although MDVs could have been used for more than one patient when aseptic technique was followed, ideally even MDVs should have been used for only one patient.

The interview was also in contrast to the facility policy Use of Multiple Dose Vials, which read multidose vials should have been for a single patient when medication was prepared at the point of use.

iii. On 10/25/22 at 4:04 p.m., an interview was conducted with Nurse Manager for the Clinics (Manager) #4, during which she stated the clinics used CDC guidelines for infection prevention and control. Manager #4 stated the entire procedure room in the General Surgery Clinic was a patient care area. She explained MDVs should not have been stored or used in patient care areas. She further explained puncturing MDVs for more than one patient after they had been opened in patient care areas could have caused cross-contamination and infection.

5. The facility failed to follow national guidelines to ensure single-use supplies were not reused on multiple patients.

i. On 10/25/22 at 11:56 a.m., observations were conducted in a procedure room in the facility's General Surgery Clinic. During these observations, Medical Assistant (MA) #2 demonstrated how she cleaned the room between patients. This demonstration included the cleaning of a portable suction machine. Suction tubing was still attached to the machine after MA #2 completed the cleaning process. MA #2 provided the packaging for the suction tubing. The package was labeled "sterile" and "single use only. Do not reuse."

During the observation, an interview was conducted with MA #2. MA #2 stated during procedures that required suction such as a paracentesis (a procedure in which a sterile needle is placed into a patient's abdomen to remove fluid) sterile suction tubing was included in the procedure's sterile supply package. She further stated during the procedure, one end of the sterile tubing remained on the sterile field and the other end was attached to the portable suction machine. This tubing was discarded at the end of the procedure. However, MA #2 explained the suction tubing that remained on the suction machine was reused between patients as it was on a separate part of the canister and did not directly touch the patient during the procedure. The tubing that remained on the suction machine completed the circuit between the suction canister and the machine itself. She stated she changed this tubing approximately weekly.

This interview was in contrast to the Centers for Disease Control and Prevention (CDC) Guideline for Disinfection and Sterilization in Healthcare Facilities, which read a reused single-use device would have had to comply with the same regulatory requirements of the device from when it was originally manufactured.

The interview was also in contrast to ANSI/AAMI ST79:2017 (AAMI), Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities, which read all medical devices were considered to be soiled and contaminated after each use and to be potential sources of infection.

iii. On 10/25/22 at 4:04 p.m., an interview was conducted with Manager #4. Manager #4 stated the clinics used CDC national guidelines to direct infection control policies and procedures. She further stated the risk for reusing single-use equipment was cross-contamination between patients.

iv. On 10/25/22 at 4:04 p.m., an interview was conducted with Director of Surgical Services Director #3. Director #3 stated the facility used AAMI guidelines to direct reprocessing and sterilization practices.

6. The facility failed to follow national guidelines and facility policy regarding the use of personal protective equipment while performing manual cleaning in the General Surgery Clinic.

i. On 10/25/22 at 11:56 a.m., observations were conducted in a procedure room in the facility's General Surgery Clinic. During these observations, MA #2 demonstrated how she performed decontamination of instruments prior to transporting them to the central processing department for sterilization. During the demonstration MA #2 used gloves, but failed to put on a gown or apron, eye protection, a mask or face shield, or a head cover.

These observations were in contrast to the Centers for Disease Control and Prevention (CDC) Guideline for Disinfection and Sterilization in Healthcare Facilities, which read personal protective equipment should have been worn when contaminated instruments, equipment, and chemicals were handled.

The observations also were in contrast to ANSI/AAMI ST79:2017 (AAMI), Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities, which read when manually cleaning devices, personnel should have worn appropriate personal protective equipment (PPE).

These observations were further in contrast to the policy Practices for Sterilization, which read the use of PPE should have been based on expected contamination levels. When performing decontamination the policy required staff to don gloves, a gown or apron, eye protection, a mask or face shield, and a head cover.

ii. On 10/25/22 at 11:56 a.m., an interview was conducted with MA #2. MA #2 stated she used the gloves as PPE to protect herself and her clothing from blood. She stated the purpose of PPE was to prevent the spread of infections.

iii. On 10/25/22 at 4:04 p.m., an interview was conducted with the Manager #4. Manager #4 stated the clinics used CDC national guidelines to direct infection control policies and procedures.

iv. On 10/26/22 at 12:17 p.m., an interview was conducted with Director #3. Director #3 stated the facility used AAMI guidelines to direct reprocessing and sterilization. Director #3 further stated the manual cleaning performed by staff in the clinics was the decontamination process, and that the process was expected to follow the same guidelines that were used in the central processing department. She explained the PPE should have been worn while staff performed decontamination which included gloves, a gown, and eye protection. She stated staff performing decontamination wore PPE to avoid becoming contaminated with blood. Director #7 stated the risk of not wearing PPE during decontamination included staff exposure to diseases and a risk of exposing other patients to diseases.

6. The facility failed to follow national guidelines to ensure single-use supplies were not reused on multiple patients.

i. On 10/25/22 at 11:56 a.m., observations were conducted in a procedure room in the facility's General Surgery Clinic. During these observations, Medical Assistant (MA) #2 demonstrated how she cleaned the room between patients. This demonstration included the cleaning of a portable suction machine. Suction tubing was still attached to the machine after MA #2 completed the cleaning process. MA #2 provided the packaging for the suction tubing. The package was labeled "sterile" and "single use only. Do not reuse."

During the observation, an interview was conducted with MA #2. MA #2 stated during procedures that required suction such as a paracentesis (a procedure in which a sterile needle is placed into a patient's abdomen to remove fluid) sterile suction tubing was included in the procedure's sterile supply package. She further stated during the procedure, one end of the sterile tubing remained on the sterile field and the other end was attached to the portable suction machine. This tubing was discarded at the end of the procedure. However, MA #2 explained the suction tubing that remained on the suction machine was reused between patients as it was on a separate part of the canister and did not directly touch the patient during the procedure. The tubing that remained on the suction machine completed the circuit between the suction canister and the machine itself. She stated she changed this tubing approximately weekly.

This interview was in contrast to the Centers for Disease Control and Prevention (CDC) Guideline for Disinfection and Sterilization in Healthcare Facilities, which read a reused single-use device would have had to comply with the same regulatory requirements of the device from when it was originally manufactured.

The interview was also in contrast to ANSI/AAMI ST79:2017 (AAMI), Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities, which read all medical devices were considered to be soiled and contaminated after each use and to be potential sources of infection.

iii. On 10/25/22 at 4:04 p.m., an interview was conducted with Manager #4. Manager #4 stated the clinics used CDC national guidelines to direct infection control policies and procedures. She further stated the risk for reusing single-use equipment was cross-contamination between patients.

iv. On 10/25/22 at 4:04 p.m., an interview was conducted with Director of Surgical Services Director #3. Director #3 stated the facility used AAMI guidelines to direct reprocessing and sterilization practices.

Based on document review and interviews, the facility failed to develop and implement infection control surveillance policies and procedures that adhered to national guidelines in four of the four outpatient clinics observed (Cross-reference A-0749).

Findings include:

References:

According to the Infection Control Plan and Risk Assessment document, the scope of services includes infection prevention and control activities, surveillance, epidemiology and outbreak investigation, education, consultation, mandatory reporting, and program policy development. The plan impacts all patients, visitors, employees, physicians, and volunteers, and is the responsibility of all facility services.

Infection Prevention will collaborate with the sterile processing department (SPD) Manager and the Surgery Director to assure regulatory compliance in sterile processing procedures. Risk mitigation will include: i. Tracking, trending, and reporting failures in sterilization practices. Interventions shall be documented. ii. Any equipment traced back to failed loads removed from rotation and reprocessed upon resolution of complications. iii. Promotion of hand hygiene amongst staff including surgical scrubs and utilization of alcohol-based hand sanitizers as appropriate. iv. Temperature and humidity will be monitored by Maintenance Staff in addition to SPD staff. v. Goal: Prevent hospital-associated infections related to reprocessing failures.

According to ANSI/AAMI ST79:2017, Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities, Handling collection and transport of contaminated items: Procedures must be developed with support from the infection prevention and control and hazardous materials personnel, to protect personnel, patients, and the environment from contaminations and to comply with OSHA regulations limiting occupational exposure to bloodborne pathogens. The healthcare facility should perform a risk analysis to ensure that the procedures are being followed, develop action plans to address problems noted during the analysis, and schedule a follow-up analysis to help ensure that the problems have been corrected.

1. The facility failed to follow the facility's infection control plan and national guidelines to ensure a process was in place to have infection prevention oversight in the outpatient Women's Health, Pediatric, Ear Nose and Throat, and General Surgery Clinics.

a. Document Review

A document review of the facility's infection control committee minutes was performed for the seven months from April through October 2022. During that time span the infection control committee had met three times: In May, July, and September 2022. The review of the meeting minutes did not reveal evidence of the outpatient clinics having had involvement with the infection control committee.

b. Interviews

i. On 10/26/2022 at 12:13 p.m., an interview was conducted with director of quality and safety (Director) #7. Director #7 stated the facility had an open position for an infection preventionist (IP), but this job posting had no applicants. She explained as the director for quality and safety, she had oversight of the infection preventionist (IP) when this job was filled. Therefore, Director #7 said she was performing the essential duties of the IP role. Director #7 stated she worked with the nurse manager for the outpatient clinics (Manager) #4 to cover this role in the outpatient clinics (clinics). She further explained the role of the IP included infection prevention policy development and risk assessments throughout the facility.

Director #7 stated the Infection Control Plan and Risk Assessment (IP Plan) was an organization-wide document that was reviewed annually. She further stated the IP Plan had been reviewed and approved in June of 2022. Director #7 explained if a department within the facility did not have a specific policy or procedure for infection prevention, the IP Plan would be used as the default policy.

ii. On 10/26/2022 at 12:13 p.m., an interview was conducted with Manager #4. Manager #4 stated as a nurse manager her role was to ensure appropriate staffing and to verify and/or provide staff education. She further explained the clinics followed the IP Plan and that part of her job duties was to translate that document into an ambulatory setting.

Manager #4 said the only infection control auditing conducted within the clinics was for hand hygiene. She further said there were otherwise no infection control projects specific to the clinics, or any planned training/process updates related to infection control in the clinic areas. Manager #4 stated in previous years, the clinics had participated in an annual skills fair, but this event had been placed on hold due to the COVID pandemic.

Manager #4 stated the purpose of conducting infection control auditing was to ensure staff correctly followed processes and procedures. She further stated if processes and procedures were not followed, steps would be missed which would result in an increased risk for the spread of infection.

iii. On On 10/26/22 at 12:17 p.m., an interview was conducted with the director of surgical services (Director) #3. Director #3 stated the facility used AAMI guidelines to direct reprocessing and sterilization.

The interviews with Director #7 and Manager #4 were in contrast to the IP Plan, which read the scope of services for the plan included infection prevention and control activities, surveillance, epidemiology and outbreak investigation, education, consultation, mandatory reporting, and program policy development. The IP plan impacted all patients, visitors, employees, physicians, and volunteers, and was the responsibility of all of the facility's services. Risk mitigation should have included tracking, trending, and reporting failures in sterilization practices. Interventions regarding these failures should have been documented.

The interviews were also in contrast to the ANSI/AAMI ST79:2017, Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities, which read procedures must have been developed with support from the infection prevention and control and hazardous materials personnel, to protect personnel, patients, and the environment from contaminations. The healthcare facility should have performed a risk analysis to ensure the procedures were being followed, developed action plans to address problems noted during the analysis, and scheduled a follow-up analysis to help ensure the problems had been corrected.