HospitalInspections.org

Based on facility policy and procedures, observations, and staff interviews, the facility staff failed to ensure with infection control program requirements by failing to clean and high level disinfect per facility policy and American National Standards for 3 of 3 specialty scopes and for failing to reprocess endoscopes hanging past the expiration date for 7 of 9 endoscopes that were hanging in the clean endoscope cabinets.

The findings include:

1. Review on 02/26/2025 of the facility policy titled "Cleaning, Disinfection and Sterilization of Equipment & (and) Environment" last reviewed on 10/14/2024 revealed "Definitions ... 2. Cleaning - The physical removal of all visible soil and organic material from objects, usually done with water with detergents or enzymatic products. Meticulous (showing great attention to detail) cleaning must precede disinfection and sterilization procedures, since materials that remain on the surfaces of instruments interfere with the effectiveness of these processes. 3. Decontamination - a procedure that removes or inactivates pathogenic microorganisms (tiny bacteria or fungi too small to see with naked eye) on objects so that they are safe to handle. 4. Disinfection - Disinfection means the use of a chemical procedure that eliminates virtually all recognized pathogenic microorganisms (organism that causes disease) but not necessarily all microbial forms (e.g., bacterial endospores) on inanimate objects. There are three levels of disinfection: high, intermediate, and low. High-level disinfection kills all organisms, except high levels of bacterial spores, and is effected with a chemical germicide cleared from marketing as a sterilant by the Food and Drug Administration. Intermediate-level disinfection kills mycobacteria (bacteria with waxy cell wall), most viruses, and bacteria with a chemical germicide registered as a 'tuberculocide (substance or process that disables or destroys bacteria)' by the Environmental Protection Agency (EPA). Low-level disinfection kills some viruses and bacteria with a chemical germicide registered as a hospital disinfectant by the EPA. 5. Spaulding classification - A strategy for reprocessing contaminated medical devices. The system classifies a medical device as critical, semicritical, or noncritical on the basis of risk to patient safety from contamination on a device. The system also established three levels of germicidal activity (sterilization, high-level disinfection, and low-level disinfection) for strategies with the three classes of medical devices (critical, semicritical, and noncritical). ... Device Classification ... Semicritical-contact mucous membranes or no-intact skin ... Examples: ... Endoscopes, ... etc. ... Spaulding Process Classification ... High level disinfection ... EPA Product Classification ... Sterilant/disinfectant ... 6. High-Level Disinfections - A process that eliminates all pathogenic microorganisms on inanimate objects with the exception of high numbers of bacterial endospores. Several factors influence the effectiveness of disinfection, including (1) the presence of organic matter, (2) proper choice of disinfectant for the object to be disinfected and (3) the concentration and exposure time of the disinfectant solution. Meticulous cleaning is required prior to immersion in disinfectant. ... General Guidelines for Use of Disinfectants: ... 5. Semicritical devices such as rectal probes, vaginal probes and cryosurgical probes can be cleaned with high-level disinfection with a non-toxic product. Use of probe covers/condoms over the instrument is encouraged but still requires the above cleaning procedures. ... 12. Always follow manufacturer's instructions for disinfectant contact time (how long the disinfectant should be wet or undisturbed on the surface to allow disinfectant to kill microorganisms effectively) for any hospital approved disinfectant. Use only hospital approved disinfectants. Management of Clean Equipment and Sterile Supplies ... 5. Semi-critical equipment, those touching mucous membranes, such as laryngoscopes, endoscopes, respiratory care and anesthesia equipment require high level disinfection according to the manufacturer's recommendations before re-use. ..."
Review of the Manufacturer's Recommendations for the "Rectal Probe" revealed Chapter 2 Probe Processing Procedures ... Probe Processing To prevent transmission of disease, adequate cleaning and disinfection are necessary before first use, between patient use, and every time the probe is stored or transported in a non-clean container like shipping case. All probes must be thoroughly cleaned prior to disinfection. ... Table 2-1 * Care Methods by type of tissue ... Type of tissue ... Mucosal or Non-intact skin ... Care Method ... Cleaning followed by High-Level Disinfection (HLD) (soaking or wipe or use of a Trophon EPR or Trophon 2) ... Table 2-3 * Products with validated efficacy performed by GE HealthCare ... Product Type ... High-level Disinfectant (Soak) ... Trade Name ... Cidex OPA (FDA cleared) ... Manufacturer ... Advanced Sterilization Products (J&J) ... Minimum Contact Time ... 12-Minute Soak ... Active Ingredient ... Ortho-phthalaldehyde ... Probe Manual Cleaning ... Probe High-Level Disinfection (HLD) High-Level Disinfection is required for devices that contact intact mucosal membranes or non-intact skin. High Level Disinfection can be performed using either disinfecting wipes (only for some probes), a disinfectant soaking method or an automated system ... Probe HLD - Soak 1. Ensure the probe has been disconnected from the console. Use necessary precautions (e.g. gloves, face screen and gown), as directed by your facility and fill a sink or basin with High-Level Disinfectant prepared in accordance with the disinfectant manufacturer's instructions to a level allowing immersion of the probe up to immersion line shown in the system user manual ... 2. Immerse probe in the disinfectant up to the immersion line shown in the system user manual and ensure no air bubbles are trapped on probe's surface. Ensure the probe remains in the disinfectant for at least the minimum contact time ... 3. Thoroughly rinse the probe by immersing it in a large volume of Critical Water for a minimum of 1 (one) minute. Remove the probe and discard the rinse water. Repeat rinsing two additional times, for a total of 3 (three) rinses. Do not reuse the water. Always use fresh volumes of water for each rinse. ... 4. Thoroughly dry all surfaces of the probe using a soft, low-/non-linting wipe or cloth, changing wipes/cloths when necessary to ensure the probe is completely dry. ... 5. If the probe is not immediately reused, store the probe in a manner that will protect and keep the probe from being recontaminated. ..."

Review on 02/26/2025 of the facility policy titled "Transesophageal Echocardiogram (TEE) Probe Cleaning" last reviewed on 07/04/2023 revealed "... Procedure: * Immediately after use the TEE probe will be wiped down using Super Sani (sanitizer) Cloths * 'Dirty' probe will be sent to the Sterile Processing Department in lined container with red cover * The Sterile Processing Department will high level disinfect the probe per manufacture guidelines * Probes are stored in the Sterile Processing Department in the TEE cabinet * Technician will notify Sterile Processing department as soon as possible when a TEE has been ordered to ensure scope is ready for use *If multiple studies are to be done in the same day, Sterile Processing will be notified as early as possible and scopes will be cleaned 'STAT'."

Review on 02/26/2025 of the facility policy titled "Speech Scope Process" last reviewed 05/04/2022 "... Procedure: 1. Prior to a procedure, speech therapy staff will notify the SPD (sterile processing department) a day prior or the morning of use. 2. Scope is placed in a lined transport tray covered with a green bag and lid. 3. SPD will notify speech therapy the scope is ready for use. 4. After use: 1. SPU (sterile processing unit) will wipe down the scope at the point of use with facility approved enzymatic cleaner. a. Place scope in the lined transport tray covered with a red bag and lid for transport. b. Notify SPD prior to transporting contaminated scope to the OR (operating room) for High Level Disinfection (HLD). 5. SPD will obtain contaminated scope to transport to the decontamination room. 1. Contaminated scope will be placed in sink with enzymatic cleaner for 10 minutes. 2. Handwash, rinse, and replace scope in transport tray and transport to HLD location. 6. Follow the Cidex OPA Test Policy. 7. Dry scope with a lint free cloth and replace in appropriate container and/or location."

Review of the "American National Standard ANSI/AAMI ST91:2021 Flexible and semi-rigid endoscope processing in health care facilities" approved by AAMI on 10/01/2021 revealed " ... r) If endoscope is transported to patient care room but not used, it shall be processed again prior to next patient use. ... 11.2 Storage of high-level disinfected or liquid chemically sterilized endoscopes 11.2.1 Storage procedures ... All critical devices (e.g., uretoscopes, bronchoscopes) not used immediately should be processed again before use. Endoscopes should not be left in the AER basin for extended amounts of time (e.g. more than one hour), otherwise the endoscope should be reprocessed through high level disinfection/liquid chemical sterilization process prior to storage or immediate clinical use. This section provides available information that can be used by health care facilities to determine maximum storage time. ... 11.2.2 Storage cabinets ... Endoscopes processed with HLD or LCS should be stored in a cabinet that is of sufficient height, width, and depth to allow flexible endoscopes to hang vertically without coiling and without any components touching the bottom of the cabinet, or the cabinet should be designed and intended by the manufacturer for horizontal storage of flexible endoscopes ... 11.2.4.1 General considerations The accepted maximum safe storage time (previously referred to as "hang time' or shelf life) for processed endoscopes before they can no longer be considered safe for patient use is not well defined. There are a limited number of studies addressing this issue. The available data suggest that the risk of contamination is reduced when storage is performed according to the endoscope and storage cabinet manufacturers' written IFU. Multiple studies support the concept of viable but non-culturable cells that persist through disinfection and remain following extended storage ... If bioburden is not eliminated prior to storage, it may become more resilient over time and continue to grow, especially if the endoscopes are stored before being completely dry ..."

Observation during tour of the Sterile Processing Department (SPD) Scope room on 02/26/2023 at 1047 revealed 3 of 3 scopes (identified as TEE scope, Rectal scope, and Speech scope) in transport containers with lids sitting on right side of room as entered the room. Two of the three containers had patient labels inside the container with the scopes indicating the person the scope was last used on. The scope nor the container was labeled or marked as not having completed the cleaning process which included high level disinfecting (HLD).

Interview on 02/26/2025 at 1047 with Registered Nurse (RN) #1 in Central Sterile Processing revealed the three scopes in the transport trays, two of which that had patient labels under the white paper and scope, were cleaned but not high level disinfected. Interview revealed the scopes were not HLD until they were called for or scheduled to be used. Once the call occurred or scope was scheduled to be used the scope is HLD. The scopes are stored in the containers in the clean scope room until they are needed. Interview revealed this process has been in place an unknown amount of time and for as long as RN #1 could remember. Follow up interview on 02/28/2025 at 1216 with RN #1 revealed if the Rectal Probe was scheduled to be used on a patient, the scope would be high level disinfected the day prior. RN #1 would validate the dates on the Cidex, perform a strip test for 90 seconds and validate a purple pass which means the Cidex is still good. The probe is taken from the clean storage room into the soiled room where it is placed in the high-level disinfectant for 12 minutes (a timer is used each time). Once the 12 minutes are up the probe is removed from the Cidex and placed in the water for 1 (one) minute. At the end of the minute the probe is removed and the water discarded, and new water added. The probe is placed in the water again for another minute. The water is discarded and replaced a second time with the probe placed in it for another minute. (total of 3 minutes each time for 1 minute each in clean water). The tray is wiped clean with a sani wipe, and the scope is dried with a lint-free towel and placed in the tray. A clear line is placed in the tray and the scope is placed in the tray with a green liner form saying the HLD has been performed, and the clear top is put in place covering the scope. The same process happens with the Speech scope. It is placed in the Cidex for 12 minutes and in rinse water three times for one-minute intervals and the water replaced after each minute. The TEE scope does have to have a leak test prior to being put in the Cidex, this is typically done with the initial cleaning process.

Interview with RN #2, the Infection Prevention Nurse on 02/28/2025 at 1315 revealed "anything can grow the longer it is allowed to sit there without the process being complete which would include the HLD. Interview follow up at 1732 revealed RN #2 did not support the practice of not completing the cleaning process of the scopes. The practice being done does not follow the manufacturer's guidelines for cleaning the scopes (TEE and Speech scopes). The interview revealed micro-organisms can potentially grow and increase the risk for patient would be increased, cross contamination, and infection in a patient.

2. Review on 02/26/2025 of the facility policy titled "Endoscope Reprocessing Procedure" last revised 01/06/2025 revealed "... Labeling and Storage ... *Hang endoscopes vertically in a ventilated area so as not to touch each other. ... * Documentation of disinfection cycles is maintained for each patient in the daily scope log. * Scopes will be labeled with 'CLEAN SCOPE' label signifying the scope was properly disinfected and ready for use. ... * Scopes will be reprocessed every five days. ..."
Review of the "American National Standard ANSI/AAMI ST91: 2021 Flexible and semi-rigid endoscope processing in health care facilities" approved by AAMI on 10/01/2021 revealed "... r) If endoscope is transported to patient care room but not used, it shall be processed again prior to next patient use. ... 11.2 Storage of high-level disinfected or liquid chemically sterilized endoscopes 11.2.1 Storage procedures ... All critical devices (e.g., uretoscopes, bronchoscopes) not used immediately should be processed again before use. Endoscopes should not be left in the AER basin for extended amounts of time (e.g. more than one hour), otherwise the endoscope should be reprocessed through high level disinfection/liquid chemical sterilization process prior to storage or immediate clinical use. This section provides available information that can be used by health care facilities to determine maximum storage time. ... 11.2.2 Storage cabinets ... Endoscopes processed with HLD or LCS should be stored in a cabinet that is of sufficient height, width, and depth to allow flexible endoscopes to hang vertically without coiling and without any components touching the bottom of the cabinet, or the cabinet should be designed and intended by the manufacturer for horizontal storage of flexible endoscopes ... 11.2.4.1 General considerations The accepted maximum safe storage time (previously referred to as "hang time' or shelf life) for processed endoscopes before they can no longer be considered safe for patient use is not well defined. There are a limited number of studies addressing this issue. The available data suggest that the risk of contamination is reduced when storage is performed according to the endoscope and storage cabinet manufacturers' written IFU. Multiple studies support the concept of viable but non-culturable cells that persist through disinfection and remain following extended storage ... If bioburden is not eliminated prior to storage, it may become more resilient over time and continue to grow, especially if the endoscopes are stored before being completely dry ..."

Observation during tour of the Sterile Processing Department (SPD) Scope room on 02/26/2023 at 1047 revealed 7 of 9 endoscopes hanging in the tower past the date of hang time (greater than 5 days per policy). The scopes were observed with "expired" written in black ink on the scope tag and expiration dates of 02/18/2025, 02/19/2025, 02/23/2025 and 02/25/2025. Two additional scopes would expire at the end of business day (02/26/2025).

Interview on 02/26/2025 at 1047 with Registered Nurse (RN) #1 in Central Sterile Processing revealed the tags on the scopes were marked when they expire. The scopes would not be used and the scopes that were out of the hang time would be reprocessed prior to being used. The interview revealed the scopes are not used everyday and they are scheduled for use so the scope can be reprocessed prior to anyone taking it.

Interview on 02/28/2025 at 1315 with RN #2, Infection Control nurse, revealed the scopes should be reprocessed per policy. Interview revealed RN #2 had not performed observations in the central sterile department since 2023. Interview revealed RN #2 planned to spend time with IC #3 in the SPD department.

NC00221078; NC00223025; NC00227494