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Based on the manner and degree of the standard-level deficiencies cited 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 must demonstrate that: 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, document reviews and interviews, the facility failed to ensure methods were put in place and followed by staff to prevent the spread of infection. Specifically, the facility failed to ensure staff reprocessed and sterilized instruments and endoscopes in accordance with national standards, facility policy and facility expectations.

Based on observations, document reviews and interviews, the facility failed to ensure methods were put in place and followed by staff to prevent the spread of infection. Specifically, the facility failed to ensure staff reprocessed and sterilized instruments and endoscopes in accordance with national standards, facility policy and expectations. (Cross reference A-0941)

Findings include:

Facility Policies:

According to the policy Endoscopes and Endoscope Accessory, Cleaning and Processing of, after each use and prior to cleaning and disinfection, pressure (i.e. leak) testing should be performed on all fiber-optic endoscopes with leak testing capabilities prior to being completely immersed in cleaning solutions or water. After testing and inspection, endoscopes and accessories are cleaned and decontaminated. Wash the external surface of the insertion tube of the endoscope with an enzymatic detergent using a soft cloth or sponge. Rinse the endoscope and all parts with tap water thoroughly to remove residual debris and cleaning agents.

According to the policy Low-Level and High-Level Cleaning and Disinfection of Equipment/Instruments, General principles of cleaning: Staff must carefully follow manufacturer's recommendations (Instructions for Use [IFU]) for cleaning prior to further disinfection of equipment.

According to the policy Surgical Instruments and Powered Equipment: Care and Cleaning of, To prevent the drying of blood or any proteinaceous materials on the instruments, after placing "used" instruments in a rigid "biohazard" container, completely spray and saturate the "used" instruments with an enzymatic solution following manufacturer's recommendations.

According to the Pre Cleaning of Critical and Semi Critical Instruments policy, the purpose of the policy is to ensure that precleaning procedures are performed at the point of use to prevent bioburden formation on instruments prior to high level disinfection or sterilization. All contaminated reusable critical and semi critical instruments are to be pretreated with hospital approved ad manufacturer recommended precleaning agent following use and prior to cleaning and high level disinfection or sterilization.

According to the policy Endoscopes and Endoscope Accessory, Cleaning and Processing Of, In accordance with the Olympus update on 12/2014 all GI -180 and 190 series scopes that are have a one-hour delay from pre-cleaning to manual cleaning and/or manual cleaning to high-level disinfection must undergo a presoak in hospital approved detergent. This soak is done until debris is visibly loosened, this is not to extend longer than 10 hours.

References:

According to The Olympus ENF-V3 Rhino-Laryngo Videoscope Reprocessing Manual, Fill a clean, large basin with the detergent solution at the concentration recommended by the detergent manufacturer. Immerse the endoscope in the detergent solution. Thoroughly brush or wipe all external surfaces of the endoscope, using a clean lint-free cloth, soft brush, or sponge. Pay particular attention to the objective lens on the distal end of the insertion section, and confirm that all debris is removed from all surfaces of the distal end. Leave the endoscope immersed in the detergent solution, according to the instructions of the detergent manufacturer. Remove the endoscope from the detergent solution. Fill a clean, large basin with the water as described in Section 3.2, "Water (for reprocessing)". Immerse the endoscope in the water and gently agitate them to thoroughly rinse.

According to the Renuzyme Plus Enzyme Detergent Product instructions for use (IFUs), Manual cleaning, Use 1-2 oz/gallon (8-16 ml/L) of water. Discard soak solution when visibly soiled. This product is most effective between the temperatures of 70-140 degrees Fahrenheit (F) (21-60 degrees Celsius (C)).

According to the Renuzyme Plus Product Specifications, soak for 1-10 minutes.

According to the Prepzyme Forever Wet Instructions for use, Spray directly on the soiled instruments and rigid scopes immediately after use. Apply product in 5-6 sweeping sprays across the tray.

According to the Teleflex Medical Metal Reusable General Surgical Instruments IFUs, directly after use, remove coarse contamination from the instrument and keep the instrument moist for transit to the processing site.

According to the Integra Kerrsion Rongeurs IFUs, to prevent formation of biofilm, cleaning should occur as soon as possible after the instrument is used. Maintain moisture: immediately after surgical procedure, place instruments in an instrument tray/container and cover with a towel moistened with sterile water. Foam, spray or gel products, specifically intended for use with surgical instruments, are avail to keep moist. Rinse foam, spray or gel products from instruments with distilled water prior to enzymatic soak.

According to the ANSI/AAMI ST91: 2021 American National Standards, Page 36, Manual cleaning steps: The following steps are recommended: Prepare fresh cleaning solution in a clean sink or basin for each endoscope according to the detergent manufacturer's written IFU for temperature, concentration, and water quality.

According to the ANSI/AAMI ST91: 2021 American National Standards, Page 62, Cleaning verification tests are performed following cleaning and before disinfection or sterilization and are used to verify the effectiveness of a cleaning process to remove or reduce to an acceptable level the clinical soil that occurs during the use of an endoscope. Methods that are able to quantitatively or chemically detect organic residues that are not detectable using visual inspection should be implemented.

According to the Association of periOperative Registered Nurses (AORN) Guidelines for Perioperative Practice, 2017:

Recommendation III.g (pg 820) Instruments should be kept moist until they are cleaned.

Recommendation X (pg 829): Surgical instruments should be inspected and evaluated for cleanliness and correct working order after decontamination and if soiled or defective, should be removed from service until they are cleaned or repaired. Items that are not clean or do not function correctly can put a patient at risk for injury or surgical site infection (SSI).

1. The facility failed to ensure endoscopes were reprocessed and surgical instruments were sterilized according to manufacturer's instructions, facility expectations and national standards.

A. Observations revealed SPD staff were conducting tasks in contrast with manufacturer's instructions and facility policy and expectations.

a. The facility failed to ensure endoscopes were reprocessed according to manufacturer's instructions, facility expectations and national standards.

i. On 7/25/22 at 4:20 p.m., observations of the sterile processing department (SPD) were conducted with the sterile processing education coordinator (Educator) #2. During the observations, sterile processing technician (Tech #1) was observed reprocessing endoscopes (a medical device used to look inside a body cavity or organ). Observations revealed Tech #1 placed an endoscope in a sink filled with water and detergent. Approximately five minutes later, Tech #1 removed the endoscope from the sink and placed it on a counter lined with a towel. Tech #1 did not perform a leak test or manually clean the endoscope with a brush or wipe all external surfaces of the endoscope in accordance with the manufacturer's instructions for use (IFU). Tech #1 then placed the endoscope into a Medivator (machine used to conduct high level disinfection to reprocess endoscopes). Tech #1 did not conduct manual cleaning of the endoscope or conduct a leak test prior to placing it into the Medivator.

This was in contrast with the IFUs for the endoscope which instructed pressure (i.e. leak) testing should be performed on all fiber-optic endoscopes with leak testing capabilities prior to being completely immersed in cleaning solutions or water. Immerse the endoscope in water with detergent and thoroughly brush or wipe all external surfaces, then rinse the endoscope in clean water.

This was also in contrast with the Endoscopes and Endoscope Accessory, Cleaning and Processing Of policy which read, after testing and inspection, endoscopes and accessories were cleaned and decontaminated.

b. The facility failed to ensure the concentration of enzymatic solution to water was in accordance with the manufacturer's instructions when manually cleaning and soaking instruments.

i. Observations of the SPD were conducted on 7/25/22 at 3:35 p.m. with the sterile processing education coordinator (Educator) #2. Observations revealed Tech #1 was preparing to soak an endoscope in enzymatic solution and water. Tech #1 placed an endoscope in a clear basin then began pouring enzymatic solution in the basin without measuring it first. Tech #1 stated he did not use a measuring device when pouring the enzymatic solution to mix it with water. Educator #2 instructed Tech #1 to stop pouring the solution in the container because the solution had to be measured.

During this observation, Educator #2 briefly left the area, then returned with a measuring cup and a syringe, which was still in its packaging. Educator #2 instructed Tech #1 to fill the syringe with enzymatic solution up to the 32 milliliter (ml) line, empty the syringe in the basin, then repeat the process for a total of five times. Then, Tech #1 was instructed to fill the basin to the five gallon line marked on the side of the basin. Tech #1 proceeded to fill the basin with water, however, Tech #1 did not verify the level of the water. Further inspection of the basin revealed the measurements on the side of the basin were in liters (L), not gallons, and the water level was below the five liter line. In addition, the concentration 32 ml of enzymatic solution to 1 L of water was in contrast with the enzymatic solution's IFUs which instructed to use 8-16 ml of enzymatic solution to 1 liter of water.

ii. On 7/25/22 at 2:55 p.m., observations of the instrument manual cleaning sinks revealed the concentration level of enzymatic solution and water was approximately one inch below the line indicated by a magnetic strip. Further inspection revealed an instrument tray was soaking in the sink.

During the observation, Tech #3 stated she was unsure of what the concentration of the water to enzymatic solution was supposed to be. Tech #3 stated the line indicated by the magnetic strip showed the level of where the water should have been filled to provide accurate concentration of the level of enzymatic solution to water.

iii. On 7/25/22 at 4:15 p.m., a second observation of the manual cleaning sinks revealed the water level to be approximately two inches below the line indicated by the magnetic strip. Further inspection revealed a different instrument tray was soaking in the sink.

c. The facility failed to ensure surgical instruments were sprayed with enzymatic solution immediately after use and prior to transporting to the SPD.

i. On 7/25/22 at 2:45 p.m., observations of the decontamination area of the SPD were conducted with Tech #3. During the observations, an instrument set and an ear nose and throat (ENT) instrument set were noticed on a counter top next to a sink. The instruments in both sets appeared dry and showed no signs of being sprayed with an enzymatic solution. Tech #3 stated all instruments were expected to be sprayed with enzymatic spray in the operating room (OR) prior to being sent to the decontamination area. Tech #3 verified both sets of instruments had not been sprayed prior to arriving in the decontamination area.

This was in contrast to the policy Pre Cleaning of Critical and Semi Critical Instruments which instructed that all contaminated reusable critical and semi critical instruments were to be pretreated with hospital approved ad manufacturer recommended precleaning agent following use and prior to cleaning and high level disinfection or sterilization.

Tech #3 then picked up a pair of scissors from one of the sets and pointed to a spot of blood located on the scissors. Tech #3 then explained the purpose of the enzymatic spray was to break down blood left on the instruments.

d. The facility failed to ensure soiled surgical instruments were soaked in enzymatic solution within the time specified by manufacturer instructions and facility policies.

i. On 7/25/22 at 3:20 p.m., observations of the decontamination area of the SPD were conducted. Observations revealed Tech #3 placing a pelvic instrument set in a sink filled with water and enzymatic solution at 3:20 p.m. At 3:55 p.m., which was 35 minutes later, the pelvic instrument set was removed from the sink.

This was in contrast with the Renuzyme Plus Product Specifications which instructed to soak for 1-10 minutes.

e. The facility failed to ensure the temperature of water and enzymatic solution used for soaking soiled surgical instruments was within the ranges specified by the manufacturer.

i. On 7/25/22 at 3:20 p.m., observations of the decontamination area of the SPD were conducted. Observations revealed Tech #3 soaked instruments in a sink. On top of the sink was a sign that read if water fell below 70 degrees to empty and refill the sink. Tech #3 stated she was not aware of what the temperature of the water should be. Tech #3 further stated she did not have a thermometer to check the temperature of the water.

During the observation, sterile processing education coordinator (Educator) #2 stated the temperature could be read from the enzymatic solution dispenser box located on top of the sink. Inspection of the dispenser box revealed the temperature was 62 degrees Fahrenheit (F). This was in contrast to the enzymatic solution's IFUs which instructed the product was most effective between the temperatures of 70-140 degrees Fahrenheit (F) (21-60 degrees Celsius (C).

Educator #2 instructed Tech #3 to empty and refill the sink. As the sink was refilling, the dispenser box revealed the temperature was still at 62 degrees. Educator #2 then pointed to a magnetic strip in the sink and stated the magnet also acted as a thermometer. The magnetic strip indicated the temperature of the water was at 110 degrees. Tech #3 stated she did not realize the magnetic strip in the sink showed the temperature of the water.

f. The facility failed to ensure endoscopes were properly tested for environmental contaminants.

i. On 7/25/22 at 4:05 p.m., observations of the endoscope reprocessing area of the SPD were conducted. Observations revealed Tech #1 performed environmental contamination testing on an endoscope. Tech #1 used a cotton tip applicator to swab the surface of an endoscope located on a counter top in the endoscope reprocessing area. Tech #1 then used a computer to input the serial number of the endoscope receiving the test; however, Tech #1 inputted the serial number of a different endoscope which was soaking in enzymatic solution. Tech #1 inserted the cotton swab into the computer reader and initiated the test. This resulted in the test being performed on the wrong endoscope. Tech #1 stated he had made a mistake and entered the wrong scope serial number into the computer.

g. The facility failed to have a process in place for when foreign matter was found on surgical instrumentation after the instruments underwent the cleaning process and prior to the sterilization process.

i. On 7/25/22 at 4:30 p.m., observations of the clean assembly area of the SPD were conducted. During the observations, sterile processing technician (Tech) #5 was observed assembling a tray of instruments. Tech #5 was observed scraping foreign matter off of a dental mirror. Tech #5 stated there was cement on the mirror and if she could scrape it all off, the instrument would then be able to go into the autoclave.

This was in contrast to AORN recommendation X which read, surgical instruments should be inspected and evaluated for cleanliness and correct working order after decontamination. If soiled or defective, should be removed from service until they are cleaned or repaired. Items that were not clean or did not function correctly could put a patient at risk for injury or surgical site infection.

h. The facility failed to ensure equipment used to clean surgical instruments were routinely tested for quality control.

i. A review of the Load Audit log for Cart Washers Cart Washers was reviewed from 6/1/22 through 7/25/22 and revealed instances of missed or incomplete testing.

ii. Cart Washer #1 was missing tests on 6/4-6/6, 6/12, 6/18-6/20, 6/25-6/27, 6/30, 7/4, 7/9, 7/10, 7/16, 7/17, and 7/21. In addition, Cart Washer #1 documented tests were incomplete with no follow up or completed on 6/2, 6/3, 6/9, 6/11, 6/14, 6/17, 6/22, 6/24, 7/8, 7/12, 7/14, and 7/20.

iii. Cart Washer #2 was missing tests on 6/4-6/6, 6/12, 6/18-6/20, 6/25, 6/26, 6/30, 7/4, 7/9, 7/10, 7/16, 7/17, and 7/21. In addition, Cart Washer #2 documented tests were incomplete with no follow up or retesting on 6/2, 6/3, 6/9, 6/11, 6/14, 6/17, 6/22, 6/24, 7/8, 7/12, 7/14, and 7/20.

iv. Washer #01 was missing tests on 6/4-6/6, 6/12, 6/18-6/20, 6/25, 6/26, 6/30, 7/4, 7/9, 7/10, 7/20, 7/21, 7/23, and 7/24. In addition, Washer #01 documented tests were incomplete with no follow up or retesting on 6/2, 6/3, 6/9, 6/11, 6/17, 6/22, 6/24, 7/8, 7/12, and 7/14.

v. Washer #02 was missing tests on 6/4-6/6, 6/12, 6/18-6/20, 6/25, 6/26, 6/30, 7/4, 7/9, 7/10, 7/20, and 7/21. In addition, Washer #02 documented tests were incomplete with no follow up or retesting on 6/2, 6/3, 6/9, 6/11, 6/17, 6/22, 6/24, 7/8, 7/12, and 7/14.

vi. Similar findings of missing tests and documented tests as incomplete with no follow up or retesting were found in the review of the Load Audit longs for Washer #03, and Washer #04.

i. The facility failed to ensure methods put in place to ensure endoscopes were being cleaned in accordance with facility policy and expectations.

i. A review of the facility's logging system for reprocessing endoscopes from 6/1/22 through 6/31/22 was conducted. The Disinfection Cycle Logs from the Medivators were compared to the Endoscope Log Book and revealed several inconsistencies. For example:

ii. On 6/4/22, documentation in the Endoscope Log Book revealed an Olympus gastrointestinal (GI) endoscope was cleaned at the bedside at 1:44 a.m. The endoscope began the cleaning
process in the SPD at 4:10 a.m., two hours and 26 minutes after the endoscope was cleaned at the bedside. There was no evidence of the scope having been presoaked in enzymatic solution.

This was in contrast to the Endoscopes and Endoscope Accessory, Cleaning and Processing Of policy which read, endoscopes that have a one-hour delay from pre-cleaning to manual cleaning and/or manual cleaning to high-level disinfection must undergo a presoak in hospital approved detergent.

iii. On 6/23/22, documentation in the Disinfection Cycle Log revealed there were nine endoscopes reprocessed. However, in the Endoscope Log Book, only one endoscope was logged as arriving in the SPD. There was no documentation or other evidence noted regarding if the other eight endoscopes required a pre soak in enzymatic solution or if a pre soak had occurred.

iv. On 6/22/22, documentation in the Disinfection Cycle Log revealed eight endoscopes were reprocessed that day. However, in the Endoscope Log Book, there were only five endoscopes logged in. There was no documentation or other evidence noted regarding if the other three endoscopes required a pre soak in enzymatic solution or if a pre soak had occurred.

v. On 6/24/22, documentation in the Disinfection Cycle log revealed eleven endoscopes were reprocessed that day. However, in the Endoscope Log Book, there were only five endoscopes logged in. There was no documentation or other evidence noted regarding if the other six endoscopes required a pre soak in enzymatic solution or if a pre soak had occurred.

B. Interviews verified SPD staff were conducting tasks in contrast with manufacturer's instructions and facility policy and expectations

a. On 7/27/22 at 2:18 p.m., an interview with SPD education coordinator (Educator) #2 was conducted.

i. During the interview, Educator #2 described the expected process for reprocessing endoscopes. Educator #2 stated SPD staff were first expected to conduct a leak test on the endoscope to ensure there were no holes in the endoscope. Educator #2 stated after the leak test was conducted, SPD staff were expected to submerge the endoscope in water with enzymatic solution and use a sponge to manually wipe down all areas of the endoscope. Educator #2 stated staff were expected to use an appropriate sized brush to clean the inside of any cannulas of the endoscope.

Educator #2 stated he noticed Tech #1 missed some critical steps during the observation of Tech #1 reprocessing the endoscope and identified Tech #1 did not perform a leak test or manually clean the endoscope before placing it in the Medivator. Educator #2 stated SPD staff were expected to have competency training annually, however, he was unsure of when the last time Tech #1 had training for endoscope reprocessing. Educator #2 stated the process of obtaining annual staff competencies regarding endoscope reprocessing was not handed down to him when he started the education coordinator position a year ago. Educator #2 further stated he had not conducted any endoscope reprocessing annual competency reviews with staff as an educator in SPD.

ii. Educator #2 stated the purpose of soaking instruments in enzymatic solution was to ensure any bioburden was broken down on the instruments. Educator #2 explained if the concentration of enzymatic solution was too low, it was possible that the solution would not break down bioburden. Educator #2 further explained if the concentration was too high, it could create a film on the instruments.

Educator #2 stated staff were expected to follow guidance from the enzymatic solution's instructions for use (IFUs) when using enzymatic solution to manually clean surgical instruments. Educator #2 then stated he was unaware of any audits being conducted to ensure the proper concentration of enzymatic solution to water was used when cleaning surgical instruments.

iii. Educator #2 stated the purpose of using enzymatic spray in the OR was to break down bioburden on instruments prior to the cleaning process. Educator #2 further stated the expectation of staff was to spray all instruments as soon as possible after use to prevent bioburden from drying on the instruments before they were sent to the SPD for cleaning and sterilization.

Educator #2 explained if instruments were not sprayed prior to being transported to the SPD, it was possible for bioburden to build up on the instruments, making them difficult to clean. Educator #2 reported occasionally seeing instruments that were not sprayed with enzymatic spray when they reached the SPD. Educator #2 reported audits of instruments sprayed in the OR prior to arriving in the SPD were completed in months prior, but was not sure what happened related to the continuation of those audits.

iv. Educator #2 stated instruments were to be soaked for five minutes and a manual clean was to be conducted if needed while soaking. Educator #2 stated the expectation of staff was to soak instruments while using a timer, but he did not know the consistency of how often staff were using timers. Educator #2 further stated if instruments were soaked too long, the finish on the instruments could become worn or a film could develop on the instruments. He stated if he entered the decontamination area of the SPD and observed instruments soaking, he would take them out of the sink as soon as possible.

v. Educator #2 stated the importance of having the water with enzymatic solution concentration at the correct temperature was because the enzymatic solution consisted of living organisms which activated at a certain temperature. Educator #2 further stated if the water temperature was out of range, the enzymatic solution would not function properly because the organisms would not be activated to clean the instruments.

vi. Educator #2 stated every endoscope was expected to be tested for contaminants to ensure they were adequately cleaned. Educator #2 explained if endoscopes failed the test, staff were expected to restart the endoscope cleaning process. Educator #2 then stated each test was recorded in the computer, however, there were no paper logs created of the tests. Educator #2 reported the SPD Manager had access to the computerized records of the tests but he was unsure if the process was being audited for accuracy.

vii. Educator #2 stated if bioburden or other contaminants were found on instruments after they were washed, the entire set of instruments should have gone back to the decontamination area to restart the process of cleaning and reprocessing. Educator #2 further stated if instruments with contaminants on them entered the washer cycle, the circulating water would potentially spread the contaminants to other instruments in the washer. Educator #2 explained instruments in the clean assembly area of the SPD were never to be wiped off if bioburden or contaminants were discovered on instruments because this was not the standard expected in the SPD.

viii. Educator #2 stated the testing of the washers should have been logged daily. Educator #2 explained if a test did not pass, staff were instructed to notify their supervisor and retest the washer again. Educator #2 continued to explain that if the washer did not pass the second test, staff were expected to call a service technician to come in and inspect the washer. Educator #2 further stated he had not been made aware of missing testing of the washers and that the SPD manager was responsible for auditing the process of ensuring washers were tested for quality control.

b. On 7/27/22 at 3:51 p.m., an interview with the manager of the SPD (Manager) #4 was conducted. Manager #4 stated she had noticed lapses in the completeness of competencies and had communicated the concerns with Educator #2, the director of the department and human resources; however, there had not been any improvements in the consistency of staff obtaining competencies. Manager #4 stated all SPD staff were expected to have competencies completed in order to ensure staff were completing tasks properly for patient safety.

i. Manager #4 stated staff were expected to check IFUs to determine how long instruments were supposed to soak in enzymatic solution

ii. Manager #4 explained staff were expected to clean endoscopes then test each endoscope for contaminants before placing them in the Medivator (machine used to conduct high level disinfection to reprocess endoscopes). Manager #4 stated she was able to access the reports of tests completed on the testing company's website; however, Manager #4 then stated she was unaware of audits being conducted to ensure all endoscopes were tested accurately.

iii. Manager #4 stated a member of the SPD staff was responsible for running tests on the washers every morning. Manager #4 explained the importance of running the test was to ensure the equipment was functioning properly. Manager #4 further stated she had conducted audits on ensuring the washers were being tested, but she did not notice any issues of missed tests or lack of follow-up when the tests failed. Manager #4 then stated if a washer was missing a test, she assumed the staff member responsible had forgotten to document that the test was completed.

iv. Manager #4 stated the Endoscope Log Book was a process that began during the previous March. Manager #4 explained the process was implemented in order to track the bedside cleaning of endoscopes and the timing of when the endoscope left the bedside to when the cleaning process started in the SPD. Manager #4 further explained endoscopes were expected to soak in enzymatic solution for an hour if it had been more than an hour after they were cleaned at the bedside.

Manager #4 then stated staff were expected to log each endoscope sent to the SPD to be reprocessed in the Endoscope Log Book. Manager #4 reported she reviewed the book to assess any missing information, then she communicated the missing information to the correct department leader. Manager #4 stated the goal was to review the Endoscope Log Book weekly.

Review of Manager #4's Scope Audit Log revealed the most recent audit was conducted on 6/13/22. There was no documentation noted regarding the follow-up of incomplete items noted on the audit log.

c. On 8/3/22 at 8:28 a.m., an interview with the vice president of the perioperative department (VP) #8 was conducted. VP #8 stated it was important to ensure endoscopes were adequately reprocessed in order to reduce bioburden (blood, tissue or other bodily fluids) on the endoscope and reduce instances of infection. VP #8 stated staff were expected to follow manufacturer's instructions when performing tasks in the SPD and staff were expected to complete annual competencies for all areas of the SPD, including reprocessing endoscopes.

VP #8 stated if bioburden or other foreign matter was found on instruments in the clean area of the SPD staff were expected to send the instruments back to restart the decontamination process. VP #8 explained the purpose of re-cleaning the instruments was to reduce the incidence of unclean instruments reaching patients. VP #8 stated staff should not have been trying to scrape or remove debris from instruments in the clean side of the SPD. VP #8 further stated brushes used to clean instruments had recently been removed from the clean area of the SPD so that staff would not think they could use them on instruments in the clean area of the SPD.

d. On 7/28/22 at 1:00 p.m., an interview with infection preventionist (IP) #6 was conducted. IP #6 stated she had been employed as an infection preventionist for approximately eleven months. IP #6 explained her role included providing infection control support to the SPD. IP #6 stated staff were expected to follow AORN and AAMI guidelines when working in the SPD.

IP #6 stated staff were expected to follow the facility policy regarding spraying instruments in the OR with enzymatic spray. IP #6 further stated the purpose of using an enzymatic spray on instruments was to remove immediate bioburden and to ensure debris did not remain on the instruments throughout the cleaning process.

IP #6 then stated she had participated in conducting informal rounding in the SPD as a learning experience and in order to become oriented to the department. IP #6 stated she did not document findings of the informal rounding. She further stated she was not aware of any auditing conducted on ensuring instruments were sprayed with enzymatic spray in the OR or soaked with enzymatic solution in the SPD in accordance with IFUs.

Based on the manner and degree of the standard-level deficiencies referenced to the Condition, it was determined the Condition of Participation §482.51 Surgical Services was out of compliance.

A-0941: The organization of the surgical services must be appropriate to the scope of the services offered. Based on observations, interviews and document review, the facility failed to ensure staff in the sterile processing department (SPD) were oriented, trained, and competent to perform reprocessing and sterilization of surgical instruments and endoscopes.

Based on observations, interviews and document review, the facility failed to ensure staff in the sterile processing department (SPD) were oriented, trained, and competent to perform reprocessing and sterilization of surgical instruments and endoscopes. (Cross Reference A-0749)

Findings include:

Facility policy:

According to the Human Resource Records Policy, an individual electronic file will be maintained for each employee. Each file will contain the following information: Hospital orientation/Training.

References:

According to the Association of periOperative Registered Nurses (AORN) Guidelines for Perioperative Practice, 2017:

Recommendation VIII (Page 807): Personnel should receive initial education and competency validation on procedures, chemicals used, and personal protection and should receive additional training when new equipment, instruments, supplies, or procedures are introduced.

Recommendation VIII.d.: Administration personnel should ensure competency validation of personnel participating in decontamination and high-level disinfection of invasive instruments.

1. The facility failed to ensure staff were trained and determined to be competent to reprocess and sterilize surgical instruments and endoscopes.

A. Observations of staff employed in the sterile processing department (SPD) revealed staff were conducting reprocessing and sterilization tasks in contrast to manufacturer's instructions for use (IFU), facility policy or without receiving competencies to determine if the staff member was deemed competent to provide services in the SPD.

a. Observations of the endoscope reprocessing area of the SPD were conducted on 7/25/22 at 3:25 p.m. During the observations, SPD technician (Tech) #1 was observed reprocessing endoscopes (a medical device used to look inside a body cavity or organ).

i. On 7/25/22 at 4:20 p.m., observations of the sterile processing department (SPD) were conducted with the sterile processing education coordinator (Educator) #2. During the observations, sterile processing technician (Tech #1) was observed reprocessing endoscopes (a medical device used to look inside a body cavity or organ). Observations revealed Tech #1 placed an endoscope in a sink filled with water and detergent. Approximately five minutes later, Tech #1 removed the endoscope from the sink and placed it on a counter lined with a towel. Tech #1 did not perform a leak test or manually clean the endoscope with a brush or wipe all external surfaces of the endoscope in accordance with the manufacturer's instructions for use (IFU). Tech #1 then placed the endoscope into a Medivator (machine used to conduct high level disinfection to reprocess endoscopes). Tech #1 did not conduct manual cleaning of the endoscope or conduct a leak test prior to placing it into the Medivator.

This was in contrast with the IFU for the endoscope which instructed to immerse the endoscope in water with detergent and thoroughly brush or wipe all external surfaces, then rinse the endoscope in clean water. This was also in contrast with the Endoscopes and Endoscope Accessory, Cleaning and Processing Of policy which read, after testing and inspection, endoscopes and accessories are cleaned and decontaminated.

ii. Observations of the SPD were conducted on 7/25/22 at 3:35 p.m. with Coordinator #2. Observations revealed Tech #1 was preparing to soak an endoscope in enzymatic solution and water. Tech #1 began pouring enzymatic solution in a clear basin without measuring it first. Tech #1 stated he did not use a measuring device when pouring the enzymatic solution to mix it with water. Coordinator #2 instructed Tech #1 to stop pouring the solution in the container because the solution had to be measured.

During this observation, Coordinator #2 briefly left the area, then returned with a measuring cup and a syringe, which was still in its packaging. Coordinator #2 instructed Tech #1 to fill the syringe with enzymatic solution up to the 32 milliliter (ml) line, empty the syringe in the basin, then repeat the process for a total of five times. Then, Tech #1 was instructed to fill the basin to the five gallon line marked on the side of the basin. Tech #1 proceeded to fill the basin with water, however, Tech #1 did not verify the level of the water. Further inspection of the basin revealed the measurements on the side of the basin were in liters (L), not gallons, and that the water level was below the five liter line. In addition, the concentration 32 ml of enzymatic solution to 1 L of water was in contrast with the enzymatic solution's IFUs which instructed to use 8-16 ml of enzymatic solution to 1 liter of water.

iii. On 7/25/22 at 4:05 p.m., observations of the endoscope reprocessing area of the SPD were conducted. Observations revealed Tech #1 performing environmental contamination testing on an endoscope. Tech #1 used a cotton tip applicator to swab the surface of an endoscope located on a counter top in the endoscope reprocessing area. Tech #1 then used a computer to input the serial number of the endoscope receiving the test; however, Tech #1 inputted the serial number of a different scope that was soaking in enzymatic solution. Tech #1 then inserted the cotton swab into the computer reader. This resulted in the test being performed on the wrong endoscope.

b. Observations of the decontamination area of the SPD were conducted on 7/25/22 at 2:15 p.m. During the observations, SPD technician (Tech) #3 was observed cleaning instruments in the decontamination area. Tech #3 stated she was employed as a traveler and had been working at the facility for two months.

i. Observations revealed Tech #3 placing a pelvic instrument set in a sink filled with water and enzymatic solution at 3:20 p.m. At 3:55 p.m., which was 35 minutes later, the pelvic instrument set was removed from the sink. This was in contrast with the Renuzyme Plus Product Specifications which instructed to soak for 1-10 minutes.

ii. On 7/25/22 at 3:20 p.m., observations of the decontamination area of the SPD were conducted. Observations revealed Tech #3 soaking instruments in a sink. On top of the sink was a sign that read if water falls below 70 degrees empty and refill the sink. Tech #3 stated she was not aware of what the temperature of the water should be. Tech #3 further stated she did not have a thermometer to be able to check the temperature of the water.

During the observation, Coordinator #2 stated the temperature could be read from the enzymatic solution dispenser box on top of the sink. Inspection of the dispenser box revealed the temperature was 62 degrees Fahrenheit (F). Coordinator #2 instructed Tech #3 to empty and refill the sink. As the sink was refilling, the dispenser box revealed the temperature was still at 62 degrees. Coordinator #2 then pointed to a magnetic strip in the sink and stated the magnet also acted as a thermometer. The magnetic strip indicated the temperature of the water was 110 degrees. Tech #3 stated she did not realize the magnetic strip in the sink showed the temperature of the water.

c. Observations of the clean assembly area of the SPD were conducted on 7/27/22 at 10:00 a.m. During the observations, SPD technician (Tech) #4 was observed assembling and preparing an instrument set for the autoclave. Tech #4 stated he had been employed at the facility for three weeks. Tech #4 stated he had not received any specific training to work in the SPD, only an overview of the different areas of the department. Tech #4 further stated he had not completed any competency lists during his three weeks at the facility.

B. Personnel file reviews revealed no evidence of training or competencies completed to determine if staff working in the SPD were competent.

a. A review of Tech #1's personnel file revealed he was hired on 1/18/19, two years prior to the survey. There was no evidence of any training or competencies completed to ensure Tech #1 was competent in performing tasks related to the reprocessing of endoscopes used in patient care.

i. Similar findings of missing staff competencies and training for endoscope reprocessing were found in the review of Tech #7's personnel file. Review of the Endoscope Log Book revealed Tech #7 performed endoscope reprocessing tasks during the months of June and July of 2022; however, there was no evidence of Tech #7 receiving training or annually competencies regarding endoscope reprocessing.

b. A review of Tech #3's personnel file revealed she was hired as a traveler on 6/2/22, 54 days prior to the observation. There was no evidence of any competencies, orientations to the department, or other means to determine if she was qualified and trained to conduct the duties assigned to her in the decontamination area of the SPD.

c. A review of Tech #4's personnel file revealed he was hired on 7/11/22, 16 days before the observation of Tech #
4. There was no evidence of any competencies, orientations to the department, or other means to determine if he was qualified and trained to conduct the duties assigned to him in the decontamination area of the SPD.

d. On 7/28/22 at 10:15 a.m., the accrediting and regulatory manager (Manager) #10 stated the personnel files provided to the surveyors for review contained all information available regarding training and competencies.

C. Interviews revealed staff were aware of lapses in the education and training of SPD staff.

a. On 7/27/22 at 2:18 p.m., an interview with sterile processing education coordinator (Educator) #2 was conducted. Educator #2 stated he had been working as the SPD education coordinator since 6/27/21 . Educator #2 explained staff competencies for endoscope reprocessing were expected to be done annually. Educator #2 then stated the process of conducting annual competencies for endoscope reprocessing had not been handed down to him when he began the role of educator and he had not been able to conduct endoscope competencies since he started working in his position.

Educator #2 stated there currently was no process for onboarding contracted traveler employees. Educator #2 stated Tech #3 was directly placed into assignments in the decontamination area of the SPD without being tested to see what her skill set was. Educator #2 further stated Tech #3 was determined to be competent to work in the SPD based on her previous experience and resume.

Educator #2 stated there had not been a consistent process for onboarding staff. Educator #2 explained that new staff would be placed on the shift they were hired to work and would be trained by other staff members on the shift. Educator #2 stated he had been tasked with obtaining staff competencies. Educator #2 further stated there were complete sections of staff training and competencies that were missing for SPD staff and that many staff members had not been trained adequately.

b. On 7/27/22 at 3:51 p.m., an interview with Manager #4 was conducted. Manager #4 stated all SPD staff were expected to have competencies completed in order to ensure they were performing tasks in accordance with guidelines for patient safety. Manager #4 stated she was aware of lapses in staff competencies being completed and had conversations with Educator #2, the vice president over the perioperative department and human resources, however, there had not been improvements with staff competencies.

Manager #4 stated the onboarding process for traveler staff should have been a similar but abbreviated process as onboarding a new permanent employee. Manager #4 explained there was a document created for new traveler staff to fill out which gauged their knowledge and determined what extra resources were needed.

Upon request, the facility was unable to provide a document filled out by Tech #3 used to gauge her knowledge of the requirements in the SPD.

Manager #4 explained her role with onboarding staff involved working with the new staff on their first day of employment. Manager #4 stated after the first day of employment, the SPD educator was responsible for determining which orientation items were necessary.

Manager #4 then explained new staff would be assigned to precept with senior technicians who had the most experience in the department. Manager #4 stated there the senior techs received no training on how to precept new staff.

c. On 8/3/22 at 8:28 a.m., an interview with the vice president of the perioperative department (VP) #8 was conducted. VP #8 stated all SPD staff were expected to have annual competencies completed in all areas of the SPD, including the decontamination area, the clean area and the endoscope reprocessing area. VP #8 stated he had noticed a lapse in the amount of education staff in the SPD had received. VP #8 stated the noticed lapses in education were in part due to the inability to maintain staffing levels and leadership roles in the department.

VP #8 explained that traveler SPD staffs' skills were expected to be validated and documented by facility staff. VP #8 stated he was unaware that there were traveler staff who were not validated at the facility.

VP #8 stated the process of onboarding new staff in the SPD included assessing their current skills levels, then validating their experience by verbalization and demonstration with the education coordinator. For new staff who had no experience in working in an SPD, VP #8 stated staff were expected to go through an orientation process and work with a preceptor with experience. VP #8 stated he was aware of lapses in the training process and stated the lapses in education were due to staffing and leadership retention issues.