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Based on interview and record review, the hospital failed to ensure the "Condition of Admission/Service" document was completed according to the hospital's policy and procedure for one of 30 sampled patients (Patient 9). This failure had the potential to not verify the patient's agreement to a general or informed consent for treatment.

Findings:

During a review of the clinical record for Patient 9, and concurrent interview with the Director for Cardiovascular Services (DCS), on 5/28/21 at 1:50 p.m., the DCS confirmed Patient 9's "Condition of Admission/Service" (COAS) for a "CT (Computed Tomography) Heart Calcium Scoring" (a diagnostic medical imaging test used to produce pictures of the coronary arteries to determine any blockage or narrowing from plaque buildup), dated 5/24/21, performed at the hospital's Imaging Department did not have a witness signature on the document.

During an interview with the Clinical Quality Outcomes Registered Nurse (CQORN) on 5/28/21 at 2:45 p.m., the CQORN stated the Senior System Director for Imaging Services (SSD) was looking to check why the witness signature was missed on Patient 9's COAS, and that the SSD stated the document should have been witnessed and signed by the registration staff in the Imaging Department.

The hospital policy and procedure, "Patient/Surrogate Decision Maker Consent," last revision dated 02/2021, indicated, " ...PROCEDURE: A. General Consent for Treatment 1. Consent for routine care is obtained by patient signature of the Conditions of Service or Admission. Routine care includes general includes X-rays, laboratory draws and administration of most medications ... D. Method of Recording Signatures: 1. All dates, times and signatures must be in ink, including the signatures of all witnesses ... E. Witness to Signatures: 1. Witnesses, in the number indicated, must always sign in the space allocated on the form as witness to the signature of the person signed the consent form ... The witness must be present when the form is signed by the patient or the patient's legal representative ..."

Based on observation, interview and record review, the hospital failed to ensure use of a "GUS" Disinfection Soak Station (an equip.m.ent that allows Transesophageal [TEE, a test that uses sound waves to produce pictures and assess the structure and function of the heart] transducers [a long, thin tube that is passed through the mouth, throat and into a patient's esophagus to provide pictures of the heart and its blood vessels] to be immersed in a high-level disinfectant solution) found in the Radiology/Imaging Department complied with manufacturer's instructions for use (IFU), nationally recognized infection control guidelines, acceptable standards of practice, and hospital policy and procedures.

1. The "Clean Supply" room of the hospital's Radiolology/Imaging Department was used for high level disinfection (a process used to disinfect, treat devices and instruments to destroy or remove all microorganisms except bacterial spores) of TEE transducers/probes.

a High level disinfection of TEE transducers/probes was performed in the "Clean Supply" room using the "GUS" unit

b Temperature and humidity were not monitored in the "Clean Supply" room of the hospital's Radiology/Imaging Department

2. Use of the "GUS" unit found in the "Clean Supply" room of the hospital's Radiolology/Imaging Department did not conform to the manufacturer's manual.

a Relative humidity was not monitored in the "Clean Supply" room

b There was no evidence the "GUS" unit was cleaned according to manufacturer's manual

3. TEE transducers/probes processed in the "Clean Supply" room of the hospital's Radiolology/Imaging Department was not in accordance to the manufacturer's Instructions for Use (IFU), nationally recognized infection control guidelines, and the hospital's policy and procedures.

a. Procedures for cleaning the TEE transducers were not followed as per the manufacturer's IFU, nationally recognized infection control guidelines, and hospital's policy and procedures

b. Use of high level disinfectant (HLD) solution was not followed as per manufacturer's IFUs, nationally recognized infection control guidelines, and hospital's policy and procedures:
b(1) HLD solution temperature was not confirmed.
b(2) TEE transducer minimum exposure time of 8 minutes was not completed.
b(3) Expired HLD solution was used.
b(4) TEE transducer Leak Test was not done.
b(5) Quality Test for HLD solution test strip was not checked.
b(6) High level disinfection solution's soaking tube in the "Clean Supply" room was dated incorrectly.
b(7)High level disinfection solution expiration dates written on the "Disinfectant Log for HLD Use and Quality Control" were incorrect.

c The hospital's policy and procedure on TEE Transducer Disinfection and Storage used by echocardiogra.m. technicians did not refer to nationally recognized infection control guidelines.

4. The TEE transducer/probe storage cabinet used to store probes processed in the "Clean Supply" room of the Radiology/Imaging Department was not cleaned and maintained according to the manufacturer's IFU, nationally recognized infection control guidelines and hospital's policy and procedures.

a There was no evidence the TEE probe storage cabinet's filters were changed as per the manufacturer's manual, nationally recognized infection control guidelines and hospital's policy and procedure.

b There was no evidence the TEE transducer storage cabinet was cleaned

c Humidity was not monitored in the Endoscopy Central Core area where the TEE probe storage cabinet was located

These failures had the potential to harm patients through transmission of infectious diseases.

Findings:

1.a On 5/24/21 at 2:45 p.m., an initial tour of the Radiology/Imaging Department located on the first floor of the hospital was conducted with the Assistant Director of Imaging (ADI), Director of Interventional Services (DIS), and Quality Review Coordinator (QRC).

During an observation on 5/24/21 at 4:01 p.m. with the ADI present, the Radiology/Imaging Department's "Clean Supply" room had storage shelving units and cabinets that held items used in the department. There was also a hand-washing sink inside the room located on the right-hand side upon entry. In the room, sterile supplies and other items found included: unopened, sterile packages of ablation probes, sterile full core biopsy instruments, sterile adult lumbar puncture trays and sterile ultrasound probe covers; unopened bottles of radiographic contrast medium, unused evacuated container bottles used for fluid collection, packages of ultrasound film/paper, battery packs for powered air-purifying respirator (PAPR), uncovered, light blue-colored pillows, unused yellow-colored container bins and lids, empty blue-colored plastic crates, boxes of bone marrow transport kits, unused stacks of paper cups, gray-colored, plastic basins labeled "TEE CLEAN RINSE" and a high-level disinfectant solution found underneath the sink cabinet that indicated, "OPEN 5/24/21, EXP 8/24/21" handwritten on the container bottle.

During an observation on 5/24/21 at 4:10 p.m. with the ADI present, there was an equip.m.ent in the room that was mounted on the wall. The equip.m.ent was in between two shelving units on an adjacent wall from the sink location and had two curved tubes held in place by a fra.m.e of metal bars. The metal bars had rust-colored spots that appeared corroded. One tube on had a black cap with a yellow sticker affixed to the tube that indicated "RINSE". The other tube did not have a cap and had a white sticker label handwritten in red ink that indicated, "NEW: 5/24/21 EXP: 8/24/21." There was also an "Ultrasound Leak Tester" device on the top compartment of the equip.m.ent with an attached probed inserted into the uncovered curved tube. Two posters were taped above the equip.m.ent that indicated, "INSTRUCTIONS FOR USE RESERT HIGH LEVEL DISINFECTANT" and "Revital-Ox RESERT [a type of high-level disinfectant solution]Solution Test Strips."

During an interview with the ADI on 5/24/21 at 4:20 p.m., the ADI stated the equip.m.ent mounted on the wall was a "GUS" machine used to clean TEE probes for echocardiogra.m.. The surveyor inquired about the appropriate location for disinfection of TEE probes. The ADI stated she felt the "Clean Supply" room was an appropriate place to do high-level disinfection of TEE probes. The ADI stated the final process of high-level disinfection done by staff in the "Clean Supply" room was a standard process. The ADI stated echocardiogra.m. technicians who worked for the heart and vascular services department used the "GUS" unit.

During a review of the "RESERT HLD (High Level Disinfection) LOG BOOK," the record titled, "Disinfectant Log for HLD Use and Quality Control" for the month of May 2021, indicated the "GUS" unit was last used by echocardiogra.m. technicians in the "Clean Supply" room of the Radiology/Imaging Department on 5/24/21. The record on 5/24/21 indicated 6 entries, " ... Date 5/24/21, Device Serial Number [TEE transducer/probe] B2VQ8T ... Exposure Time ... Time In 8:23 Time Out 8:41; Date 5/24/21, Device Serial Number B34Z2T ... Exposure Time ... Time In 8:40 Time Out 9:20; Date 5/24/21, Device Serial Number B3PG68 ... Exposure Time ... Time In 10:34 Time Out 10:42; Date 5/24/21, Device Serial Number B3PG6P ... Exposure Time ... Time In 11:23 Time Out 11:45; Date 5/24/21, Device Serial Number B2VQ8T ... Exposure Time ... Time In 11:56 Time Out 12:04; Date 5/24/21, Device Serial Number B34Z2T ... Exposure Time ... Time In 12:30 Time Out 12:38 ..."

During further review of the "Disinfectant Log for HLD Use and Quality Control" records indicated TEEs were processed in the "GUS" unit in the following months: From "3/1/21" through "3/31/21," there were 86 total entries; From "4/1/21" through "4/29/21," 66 total entries; and From "5/3/21" through "5/24/21," 50 total entries.

On 5/24/21 at 4:30 p.m. the Assistant Director of Imaging (ADI) and Manager for Heart and Vascular Services (MHVS) were interviewed. MVHS stated he had oversight of the "GUS" unit and TEE probes processed in the "Clean Supply" room of Radiology/Imaging Department. MVHS stated high-level disinfection (HLD) of TEE probes at this location had been in place since 2010. MVHS stated the "Clean Supply" room was an acceptable space for the "GUS" unit and HLD of TEE probes. The ADI stated Infection Control staff were aware of the "GUS" unit and HLD set up in the "Clean Supply" room.

During a follow-up interview with the MHVS and the Manager of Accreditation and Public Reporting (MAPR), on 5/25/21 at 10 a.m., stated the Senior System Director for Imaging Services (SSDIS) had prior oversight of the "GUS" unit and TEE HLD in the Radiology/Imaging Department. MVHS stated echocardiogra.m. technicians who worked under the heart and vascular services performed HLD of TEE probes in the "Clean Supply" room of the Radiology/Imaging Department. However, TEE probes used in the operating rooms (ORs) were processed by Sterile Processing Department (SPD) staff in the SPD. MHVS stated he was not sure who performed maintenance checks on the "GUS" unit located in the "Clean Supply" room of the Radiology/Imaging Department. MHVS said, "we're getting rid of it [GUS station] ... retiring it." The MAPR stated high level disinfection of TEE probes in the "Clean Supply" room of the Radiology/Imaging Department was not acceptable because "it's [TEE probes] still considered dirty even if pre-cleaned ... dirty versus clean cannot be mixed together ... unfortunately, it's in imaging [department] ..." MHVS was unable to state infection control guidelines followed by the hospital for high level disinfection of TEE probes.

During an interview with the Infection Prevention Nurse (IPN) and Interim Infection Preventionist (IIP), on 5/25/21 at 12:32 p.m., both IPN and IIP stated the hospital followed the Association of Perioperative Registered Nurses (AORN, a nationally recognized organization that provide resources and evidence-based guidelines for perioperative practice to ensure patient safety and quality care outcomes ) Guidelines for Infection Control Practices and Manufacturer's Instructions for Use (IFUs) on TEE probe processing. The surveyor asked both IPN and IIP if they were aware high level disinfection (HLD) of TEE probes took place in the "Clean Supply" room of the Radiology/Imaging department. IPN said, "that was new to me." IIP stated, "can't recall ... recently, can't give a specific date ..." IPN stated the "Clean Supply" room was not an appropriate location to do HLD. IPN stated HLD should be done in a designated area and said she would suggest HLD be done in the deconta.m.ination area of the sterile processing department (SPD). IPN stated HLD should not be done in a "Clean Supply" room "because you have clean supplies ... not specifically designated for high level disinfection ... potential risk for conta.m.ination and transmission of germs to clean supplies ..."

During a review of AORN's "Guidelines for Perioperative Practice," online publication date revised 10/2020, the document indicated, " ...Instrument Cleaning ... 2.2 Perform cleaning and deconta.m.ination in an area separate from locations where clean items are handled. Physical separation of deconta.m.ination areas from areas where clean items are handled minimizes the risk of cross conta.m.ination. Cross conta.m.ination can result when soiled items are placed near clean items or are placed on surfaces upon which clean items are later placed. Droplets and aerosols created during cleaning of soiled instruments can conta.m.inate nearby clean items or surfaces ..."

During a review of ANSI/Aa.m.I (Association for the Advancement of Medical Instrumentation, a professional organization that provides standards and guidelines for the medical device industry and sterilization professionals) ST79 "Comprehensive Guide to Stea.m. Sterilization and Sterility Assurance in Health Care Facilities," publication dated 2017, the document indicated, " ...3.2.1.2 Deconta.m.ination area/room ... Design considerations should include ... c) locations for receipt and holding of medical devices ... that are awaiting processing ... f) whether a pass-through system will be included to move equip.m.ent and instruments from the deconta.m.ination room/area to the clean room/area ... h) space, location, and utilities for all equip.m.ent that will be used; i) space and location for vertical soaking containers; j) personnel comfort and safety requirements including a system to separate soiled, in-use bottles of detergents, disinfectants, and other such supplies ... PPE requirements, including space for donning and removing, disposal and storage; k) quantity and placement of hand sanitizers and sinks designated only for hand hygiene ... m) storage requirements including space for deconta.m.ination supplies, chemicals, environmental cleaning supplies that will be used only in the deconta.m.ination area ... 3.2.2 Functional workflow patterns - The sterile processing department/area should include a) functionally separate areas within the deconta.m.ination area/room for ... receipt and processing of conta.m.inated items for which the deconta.m.ination process incorporates disinfection procedures ... receipt and processing of equip.m.ent that require manual disinfection after cleaning; b) a designated, separate clean work room for packaging, sterilization and storage of clean items; c) walls or partitions between functional work areas to control conta.m.inants generated during the phases of reprocessing ... f) a workflow pattern that allows items to move progressively from being conta.m.inated to being safe to handle, whether manually (i.e., a pass-thru window) or via mechanical cleaning equip.m.ent. In hospitals, the deconta.m.ination area/room and the packaging, sterilization and sterile storage rooms should be in physically separate rooms ... Rationale: Separating "clean" and "dirty" areas limits environmental conta.m.ination and, therefore, the a.m.ount of bioburden on devices to be sterilized. Adherence to these functional design recommendations helps contain potential conta.m.inants within a particular portion of the deconta.m.ination area and thus helps prevent cross-conta.m.ination or reconta.m.ination ..."

b During an observation of the "Clean Supply" room located in the Radiology/Imaging Department on 5/24/21 at 4:02 p.m., with the Assistant Director of Imaging (ADI) present, the thermometer inside the room indicated a temperature reading of "73.4" ° Fahrenheit (F) and "39" (%) relative humidity. The surveyor asked who checked and monitored the temperature and humidity in the room, and the ADI stated she was not sure.

During an interview with the Manager of Accreditation and Public Reporting (MAPR), on 5/26/21 at 12:08 p.m., the surveyor requested the Temperature and Relative Humidity Log for the "Clean Supply," room in the Radiology/Imaging Department for March through May 2021.

During a review of the "Disinfectant Log for HLD Use and Quality Control" for the period March 1,2021 through May 24, 2021, the record did not indicate room temperatures for the "Clean Supply" room of the Radiology/Imaging Department on the following dates: 3/6/21, 3/7/21, 3/13/21, 3/14/21, 3/20/21, 3/21/21, 3/28/21, 4/2/21, 4/3/21, 4/4/21, 4/9/21, 4/10/21, 4/11/21, 4/17/21, 4/18/21, 4/24/21, 4/25/21, 4/30/21, 5/1/21, 5/2/21, 5/8/21, 5/9/21, 5/10/21, 5/16/21, 5/22/21 and 5/23/21.

During an interview with the Director of Facilities (DOF) on 5/27/21 at 5:43 p.m., the surveyor asked the DOF how temperature and humidity were monitored in the "Clean Supply" room of the Radiology/Imaging Department. The DOF stated he did not believe relative humidity was monitored in the room. The DOF did not have records of relative humidity monitoring in the "Clean Supply" room.

During a review of AORN's "Guidelines for Perioperative Practice," online publication date revised 9/2018, the document indicated, " ... 4. Storage of Sterile Items 4.1 Store sterile items in a controlled environment. Limiting exposure to moisture, dust, direct sunlight, handling, and temperature and humidity extremes decreases the potential for conta.m.ination and degradation of sterilized items. Factors that contribute to conta.m.ination include handling, air movement, humidity, temperature, location of storage, dust, presence of vermin, whether shelving is open or closed, and properties of the sterile barrier system..."

During a record review of AORN's "Guidelines for Perioperative Practice," dated 8/15/18, the document indicated, " ... Sterilization ... What conditions are necessary for storage of sterile supplies? Environmentally controlled conditions, which include a maximum temperature of 75° F (Fahrenheit) (24° C), a maximum relative humidity of 60%, positive air pressure in relation to adjacent areas, and a minimum of four air exchanges per hour ... The user should check the conditions specified by the manufacturers of the materials being stored and ensure para.m.eters for the storage space meet the device and packaging system manufacturers' requirements ..."

a During an observation of the "Clean Supply" room located in the Radiology/Imaging Department on 5/24/21 at 4:02 p.m., with the Assistant Director of Imaging (ADI) present, the thermometer inside the room indicated a temperature reading of "73.4" ° Fahrenheit (F) and "39" (%) relative humidity. The surveyor asked who checked and monitored the temperature and humidity in the room, the ADI stated she was not sure.

During an interview with the Director of Facilities (DOF) on 5/27/21 at 5:21 p.m., the DOF stated he was not aware there was a "GUS" unit in the "Clean Supply" room of the Radiology/Imaging Department. The DOF stated he did not know when the "GUS" unit was installed.

During an interview with the Director of Facilities (DOF) on 5/27/21 at 5:43 p.m., the surveyor asked the DOF how temperature and humidity were monitored in the "Clean Supply" room of the Radiology/Imaging Department. The DOF stated he did not believe relative humidity was monitored in the room. The DOF did not have records of relative humidity monitoring in the "Clean Supply" room.

During a review of the manufacturer's "GUS Disinfection Soak Station for Transesophageal Ultrasound Probes Operator's Manual," dated 2019, the document indicated, " ...Environmental Conditions ... Temperature range: 5°C to 40°C (Celsius) [41°Fahrenheit (F) to 104°F]. Maximum relative humidity: 80% for temperatures up to 31°C [87.8°F], decreasing linearly to 50% relative humidity at 40°C [104°F] ..."

b. During an observation on 5/24/21 at 4:10 p.m. with the ADI present, there was equipment in the room that was mounted on the wall. The equip.m.ent was in between two shelving units on an adjacent wall from the sink location and had two curved tubes held in place by a fra.m.e of metal bars. The metal bars had rust-colored spots that appeared corroded. One tube had on a black cap with a yellow sticker affixed to the tube that indicated "RINSE". The other tube did not have a cap and had a white sticker label handwritten in red ink that indicated, "NEW: 5/24/21 EXP: 8/24/21." There was also an "Ultrasound Leak Tester" device on the top compartment of the equipment with an attached probed inserted into the uncovered curved tube. Two posters were taped above the equip.m.ent that indicated, "INSTRUCTIONS FOR USE RESERT HIGH LEVEL DISINFECTANT" and "Revital-Ox RESERT Solution Test Strips."

During an interview with the ADI on 5/24/21 at 4:20 p.m., the ADI stated the equip.m.ent mounted on the wall was a "GUS" machine used to clean TEE probes for echocardiogra.m..

During an interview with Cardiac Sonographer (CS) 1 on 5/25/21 at 11 a.m., the CS 1 stated his duties included high level disinfection of TEE probes. CS 1 stated he used the "GUS" station located in the "Clean Supply" room of the Radiology/Imaging Department yesterday [5/24/21].

During an interview with CS 1 on 5/25/21 at 11:30 a.m., the surveyor asked CS 1 how the "GUS" machine was cleaned. CS 1 stated the technicians [echocardiogra.m. sonographers] did not clean the "GUS" station.

During an interview with CS 2 on 5/28/21 at 3:45 p.m., CS 2 stated he would clean the "GUS" machine and wipe down the exterior surface with a "purple" Sanicloth disinfectant wipe. CS 2 stated the technicians never used the "rinse" tube of the "GUS" unit. CS 2 described how he cleaned the "soak" tube [tube containing high level disinfectant solution where the TEE transducer/probe is inserted]. CS 2 stated he emptied out the Resert (high level disinfectant solution) out and rinsed the tube with sterile water and flushed it back and forth. CS 2 stated he used a long brush to clean the soaking tube. CS 2 stated the tube was cleaned once every 21 days.

During a review of the manufacturer's "GUS Disinfection Soak Station for Transesophageal Ultrasound Probes Operator's Manual," dated 2019, the document indicated, " ...Cleaning the System - NOTE: Do not wipe surfaces with hard or abrasive materials. Doing so will scratch the surfaces. 1. Turn the power switch OFF and disconnect the power cord from the wall-mains outlet. 2. To clean the acrylic tubes use the cleaning brush provided with your system and a mild detergent. Do not use solvents. 3. To clean metal surfaces: Use a clean, lint-free cloth moistened with a mild detergent solution and water. Wipe off any drips around the tubes and below the shelf ..."

a. During an interview with Cardiac Sonographer (CS) 1 on 5/25/21 at 11:05 a.m., CS 1 stated he would begin pre-cleaning of TEE transducer/probe at the point-of-use location. CS 1 stated he used a red, endozime sponge (pre-packaged sponge saturated in bacteriostatic enzymatic cleaner used to clean outer surfaces of endoscopes and tubular instruments) to remove gross contaminants from the TEE transducer, and placed it in a TEE probe designated tray. CS 1 stated after this process, he took the TEE probe inside the tray down to the "dirty room" located in the Radiology/Imaging Department. CS 1 stated in the room, he used a white-colored container and rinsed off the TEE probe with distilled water for 3 minutes. After rinsing, he transferred the TEE probe back to the probe tray covered with a red plastic liner and took the tray to the "Clean Supply" room where high level disinfection of the TEE probe was performed. CS 1 also explained how he checked potency of the high level disinfectant solution using test strips and how he performed leakage test on TEE probes. CS 1 stated after the TEE probe passed a leak test, he inserted the TEE probe in the "GUS" soaking tube that contained the high level disinfectant solution for 8 minutes and filled out the HLD log record to ensure everything was up to date. CS 1 stated after this process, he removed the TEE probe and placed it in a basin submerged in distilled water for three, 1-minute rinses in the sink. CS 1 stated he used a clean washcloth and ran it through the clean TEE probe to dry and placed it back in the TEE tray covered with a new liner. CS 1 stated the TEE tray with the clean TEE probe was brought to the Endoscopy Unit for final storage.

During a review of the manufacturer's user manual titled, "Philips Care and Cleaning of Ultrasound Systems and Transducers" dated 8/2020, the document indicated, " ...Cleaning and Disinfecting TEE Transducers ... Cleaning the TEE Transducer with Sprays or Wipes 1. Remove any debris, residual gel, or body fluids from the device by using a soft moist cloth da.m.pened with potable water or an approved cleaning or disinfectant agent or by using an approved pre-saturated cleaning or disinfectant wipe. Use a gentle wiping motion to remove gel from the lens. If applicable, remove the transducer cover. 2. Remove any remaining gel from the transducer flexible shaft, distal tip, and lens by using running water (not to exceed 43°C (110°F) and a soft sponge or gloved hand. If running water is not available, use a pre-moistened soft cloth, such as a flushable cleaning cloth. Use a gentle wiping motion to remove gel from the lens. 3. Remove any particulate matter or body fluids that remain on the transducer using commercially available cleaning wipes or sponges (enzymatic or non-enzymatic), or a soft cloth lightly da.m.pened in a mild soap. Enzymatic cleaners and mild soaps are generically approved for use. Use a gentle wiping motion to clean the lens. 4. Unless the manufacturer's instructions for use state that rinsing with water is not required, rinse the transducer flexible shaft and distal tip thoroughly with running water or by immersing in warm water to remove the remaining cleaning solution. The water temperature should be from 32°C to 43°C (90°F to 110°F). 5. Allow the device to air dry, unless the manufacturer's instructions for use specifically state that drying is not required for the deconta.m.ination method used, or use a soft, dry, lint-free cloth to dry the transducer. Wet surfaces have the potential of diluting the disinfectant. The transducer is ready for high-level disinfection using a high-level disinfectant, or for sterilization using a sterilant ..."

During a review of the manufacturer's user manual titled, "Philips Care and Cleaning of Ultrasound Systems and Transducers" dated 8/2020, the document indicated, " ...High Level Disinfecting ... TEE Transducers ... Recommended supplies: Compatible high-level disinfectant (HLD) ... Soaking and rinsing trays ... Soft, dry, lint-free cloth (for high-level disinfection procedure) ... NOTE -If your institution requires IAC accreditation for leakage testing of TEE transducers, you are required to conduct a stand-alone test on your TEE transducers with the Fluke ULT800 Tester, or equivalent, before every use.
1. Read the label of the HLD or S solution to confirm efficacy and ensure that the solution has
not expired. 2. In a soaking tray, prepare the HLD or S solution according to the manufacturer's
instructions ... 3. Position the transducer in the soaking tub ... 4. Soak or reprocess the transducer for the prescribed length of time. 5. If you soaked the transducer (did not use an automated TEE transducer disinfector or automated TEE transducer cleaner disinfector), rinse the transducer thoroughly with running water or by immersing in warm water to remove the remaining disinfectant solution. The water temperature should be from 32°C to 43°C (90°F to 110°F). Follow the disinfectant or sterilant manufacturer's guidelines to assure complete removal of residual solution. 6. If required, allow the transducer to air dry, or dry the transducer using a soft, dry, lint-free cloth or a soft, dry, lint-free, sterile cloth. 7. Exa.m.ine the transducer for da.m.age, such as cracks, splitting, fluid leaks, or sharp edges or projections ... 8. Store the transducer in a well-ventilated area, with the handle and connector supported and positioned above the transducer. This aids with drying and reduces the risk of residual fluids from the transducer draining into the handle and connector ..."

During review of AORN's "Guidelines for Perioperative Practice," online publication date revised 1/2018, the document indicated, " ... High-Level Disinfection ... 5. Preparation of items for Disinfection 5.1 Prepare reusable semicritical items to be processed by high-level disinfection according to the device manufacturer's IFU (Instructions For Use). The device manufacturer is responsible for ensuring the device can be effectively cleaned and for providing validated cleaning instructions. Preparing the device for high-level disinfection by effective cleaning, rinsing, purging, and drying is a critical step necessary to reduce bioburden and moisture to a level that does not present a challenge to subsequent high-level disinfection ... 5.2.1Preclean at the point of use...Precleaning at the point of use assists with moistening, diluting, softening, and removing organic soils and reducing the formation of biofilm that might prevent effective high-level disinfection. 5.3 After precleaning at the point of use or after use, personnel must transport conta.m.inated items to be prepared for high-level disinfection in a closed container or closed transport cart. Transporting items to the deconta.m.ination area in a manner that prevents exposing personnel to blood, body fluids, and other potentially infectious materials is a regulatory requirement ... 5.4 After transport of items to the deconta.m.ination area, leak test items designed to be leak tested in accordance with the device and leak-testing equip.m.ent manufacturers' IFU ... 5.5 After transport of items to the deconta.m.ination area or after leak testing, clean the items in accordance with the device manufacturers' IFU ... 5.6 After cleaning, rinse the item and flush any lumens or channels with utility water in accordance with the device manufacturer's IFU ... 5.7 After rinsing, remove visible moisture from the external surfaces of the device using a clean, lint-free cloth ... 5.8 After removing visible moisture and purging, inspect the item for cleanliness, da.m.age, and function ...6. Preparation and Use of HLDs 6.1 Personnel must prepare and use HLDs in accordance with the disinfectant and device manufacturers' IFU ... 6.2 Monitor processes for manual chemical high-level disinfection and the use of HLDs within the health care organization. Oversight of high-level disinfection processes by an interdisciplinary tea.m. supports safe use of HLDs and implementation of work practices that will reduce occupational and patient exposure to HLDs. Reducing the risk of patient infection associated with inadequate disinfection or sterilization of medical devices is a regulatory requirement and an accreditation agency standard for both hospitals and a.m.bulatory settings ..."

During a review of the hospital's policy and procedure (P&P) titled, "Imaging Services - TEE Disinfection and Storage," dated 4/2019, the P&P indicated, " ...I. COVERAGE: All staff reporting to Imaging Services who work with the TEE probe II. PURPOSE: To ensure compliance with infection control requirements in regards to the TEE disinfection and storage ... IV. REFERENCES: AirClean Systems Operator's Manual, CleanShield Probe Storage Cabinet V. PROCEDURE: A. Post procedure: Wipe down used TEE probe with Sani Cloth AF3 (gray top) and transport to Dirty Utility Room in probe tray with liner. B. Dirty Utility Room: 1. Run red endozyme sponge down length of scope to remove gross soil. Discard sponge. 2. Secondly, wipe with blue sponge to remove any additional gross soil. Discard sponge. 3. Place probe in transport tray to take to HLD clean room C. HLD Clean Room: 1. Perform leak test: a. Place probe in Resert tube b. Place black wire from the ULT-22 ultrasound transducer leakage tester into the Resert tube c. Connect probe to wall unit d. Turn on leak tester and perform "full test" e. If probe fails leak test: Troubleshoot ... 2. Resert HLD cleaning: a. Prior to using solution, test using one chemical indicator and wait for passing results before putting probe in solution b. Test resert temperature c. Place probe in Resert solution and set timer for 8 minutes d. Remove probe and wash off probe under running water for 1 minute e. Pat probe dry with lint free towel and place probe cover on probe tip. F. Record information in log book (i.e. probe number, room temp, Resert test results, etc.) g. Transport clean probe to Probe Storage cabinet, using TEE tray with green liner ..."

b(1) During a review of the "Disinfectant Log for HLD Use and Quality Control," for the period March 1,2021 through May 24, 2021, the log had no temperature records of the high level disinfectant (HLD) solution used. The logs' third column that indicated, "Resert [high level disinfectant solution] HLD Temp >68F [Fahrenheit] or >20C [Celsius]" were all blank for the months of March, April and May 2021.

During a concurrent interview and record review, on 5/28/21 at 4:15 p.m., with Cardiac Sonographer (CS) 2, the "Disinfectant Log for HLD Use and Quality Control," records for the period March 1,2021 through May 24, 2021 were reviewed. The surveyor discussed the missing temperature readings of the HLD solution used. CS 2 stated he was not sure if the Resert HLD (solution) temperatures had to be filled out. The surveyor asked CS 2 why temperatures had to be checked. CS 2 said, " ...don't know, that's always the form that's been here ..."

During a review of the manufacturer's Instructions For Use (IFU) titled, "Revital-Ox RESERT R60 Solution Test