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Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §416.51 INFECTION CONTROL was out of compliance.

A-0749 (a)(2) 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 a functional and sanitary environment for surgical services to avoid sources and transmission of infections and communicable diseases. Specifically, the facility failed to ensure surgical instruments were processed in accordance with facility policies and manufacturer instructions for use (IFU) in one of one observations in the emergency department (ED).

Based on observations, document reviews, and interviews, the facility failed to ensure a functional and sanitary environment for surgical services to avoid sources and transmission of infections and communicable diseases. Specifically, the facility failed to ensure surgical instruments were processed in accordance with facility policies and manufacturer instructions for use (IFU) in one of one observations in the emergency department (ED).

Findings include:

Facility policy:

The Sterile Processing Procedures policy read, items to be sterilized must be cleaned, inspected, decontaminated, sterilized, and stored in a controlled environment. For instrument cleaning and decontamination, the following steps must be followed: Refer to the manufacturer ' s instructions or guidelines for specific care instructions for each instrument prior to proceeding. All objects to be sterilized must first be thoroughly cleaned to remove all bioburden and other residue. Soiled objects shall be placed in a designated covered container and sprayed with an enzymatic foam or gel at the point of use. The items will then be taken to the Sterile Processing Department for reprocessing or cleaned in the OR decontamination room if applicable.

References:

According to the Association for the Advancement of Medical Instrumentation (AAMI) Sterile Processing - Manufacturer ' s Instructions; the manufacturer ' s written IFU for the cleaning and sterilization of surgical instruments should be read, understood, and followed by those responsible for processing the instrument. The cleaning process should be audited to ensure that the procedures being used comply with the manufacturer ' s written IFU and that the personnel performing cleaning procedures have received documented training and have demonstrated competency in the cleaning process.

According to the Association for the Advancement of Medical Instrumentation (AAMI) Sterile Processing - Precleaning: instruments should be precleaned immediately following use. Gross debris should be removed, and instrument lumens should be flushed with sterile distilled water as recommended by the manufacturer. The instruments should be maintained in a moist state before cleaning in order to prevent the drying of surgical debris onto or within them.

According to the Association for the Advancement of Medical Instrumentation (AAMI) Sterile Processing - Transport of Instruments; during transport of instruments from the point of use to the decontamination area, appropriate precautions (e.g., use of a closed transport container) should be taken to avoid personnel exposure to blood-borne pathogens, contamination of the work environment, and further contamination of the instruments. The time between using instruments and cleaning them should be kept to a minimum.

The BD MEDICAL/ CAREFUSION / V. MUELLER General Surgical Instrument IFU read, Point of Use Pre-processing Instructions: Initiate cleaning of device within two hours of use. Remove excess gross soil as soon as possible after use by rinsing or wiping the device. Disassembly Pre-processing Instructions: All devices must be processed in the completely open position (i.e. flushports, jaws, etc.) to allow solution contact of all surfaces.

Warnings: device shall be used in accordance with these IFU. Improper use of these devices may cause serious injury. In addition, improper care and maintenance of the devices may render the devices non-sterile prior to patient use and may cause serious injury to the health care provider or the patient.

The KARL STROZ Surgical Instrument IFU read, failure to follow the instructions, cautions, and warnings presented in this manual may result in serious consequences to the patient.

Pre-cleaning: Potable water may be used for pre-cleaning and rinsing a device immediately after patient use to remove gross contamination. Water temperature should not exceed 113°F (45°C) to prevent coagulation of blood and other proteins.

Pre-Cleaning Preparation: Immediately after a procedure, at the point of use (e.g. operating room), wipe the instruments with a soft, lint-free, disposable cloth, moistened with water to remove all heavy soiling. Contain and transport the contaminated instruments with a soft, lint-free, disposable cloth, moistened with water or cleaning detergent to remove all heavy soiling.

The Prepzyme® Forever Wet IFU read, the enzymatic humectant spray which promotes the long lasting retention of moisture on all soiled instruments and scopes, helping to prevent the adhesion of bio-burden. Spray directly on the soiled instruments and scopes immediately after use. Apply product in five to six sweeping sprays across the tray. Allow the instrument or scope to set in Prepzyme® Forever Wet until ready for cleaning. As long as all surfaces have been completely covered, it is not necessary to reapply as moisture is retained. Rinse thoroughly before cleaning.

1. The facility failed to pre-clean all surgical instruments prior to sterilization in accordance with the instruments' IFU. Additionally, the facility failed to place contaminated surgical instruments in a designated covered container and spray them with an enzymatic foam or gel at the point of use in accordance with the facility policies.

A. Observations

i. On 9/30/24 at 12:05 p.m., observations were conducted in the ED. Observations revealed a soiled utility closet that contained biohazardous (waste that contains infectious or potentially infectious substances) materials with the door latch taped closed, which prevented the door from closing and locking. The soiled utility closet was located across from three treatment rooms designed for psychiatric patients. Additional observations revealed soiled hinged surgical instruments in a closed position placed directly on the counter. Sterile processing technician (Tech) #1 stated the surgical instruments should have been placed in a rigid biohazard container with a lid for safety. Tech #1 stated the instrument's hinges were visibly soiled. Tech #1 stated the instruments were dry and not sprayed with the enzymatic cleaner with the hinges in an open position. Tech #1 was unable to state how long the soiled surgical instruments had been sitting there. Tech #1 stated when surgical instruments were not cleaned per the IFU, there could be bioburden left behind, increasing the patient ' s risk of infection.

The observations on 9/30/24 were in contrast to AAMI guidelines which read, instruments were to be precleaned immediately following use. Gross debris was to be removed, and instrument lumens were to be flushed with sterile distilled water as recommended by the manufacturer. The instruments were to be maintained in a moist state before cleaning to prevent the drying of surgical debris onto or within them.

The observations on 9/30/24 were in contrast to AAMI guidelines which read, during transport of instruments from the point of use to the decontamination area, appropriate precautions (e.g., use of a closed transport container) were to be taken to avoid personnel exposure to blood-borne pathogens, contamination of the work environment, and further contamination of the instruments. The time between using the instruments and cleaning them was to be kept to a minimum.

The observations on 9/30/24 were in contrast to the BD MEDICAL/ CAREFUSION / V. MUELLER General Surgical Instrument IFU which read, initiation of cleaning of the device was required within two hours of use. Excess gross soil was to be removed as soon as possible after use by rinsing or wiping the device. All devices had to be processed in the completely open position (e.g., flushports, jaws) to allow solution contact on all surfaces.

The observations on 9/30/24 were in contrast to the KARL STORZ Surgical Instrument IFU which read, potable water was to be used for pre-cleaning and rinsing a device immediately after patient use to remove gross contamination. Pre-cleaning preparation required, immediately after a procedure and at the point of use (e.g., operating room), the instruments be wiped with a soft, lint-free, disposable cloth moistened with water to remove all heavy soiling. Contaminated instruments were to be contained and transported with a soft, lint-free, disposable cloth moistened with water or cleaning detergent to remove all heavy soiling.

The observations on 9/30/24 were in contrast to the Prepzyme® Forever Wet IFU which read, spray directly on the soiled instruments and scopes immediately after use and apply the product in five to six sweeping sprays across the tray. The instrument or scope was to be allowed to set in Prepzyme® Forever Wet until ready for cleaning. As long as all surfaces were completely covered, reapplication was not necessary, as moisture was retained. The instruments were to be rinsed thoroughly before cleaning.

B. Interviews

i. On 9/30/24 at 12:12 p.m., an interview was conducted with emergency department charge nurse (RN) #2. RN #2 stated the emergency department staff was responsible for cleaning and storing the equipment before transporting it to the sterile processing department (SPD). RN #2 stated the surgical instruments were visibly soiled and the hinges were left in a closed position. RN #2 stated the instruments were dry and had not been sprayed with the enzymatic humectant spray. RN #2 said they were not aware when the surgical instruments had been pre-cleaned or how long they had been sitting there. RN #2 stated the soiled surgical instruments should have been placed in a biohazard container and not directly on the counter. RN #2 stated instruments not secured in a biohazard container put the staff at risk of injury and potential infection. RN #2 stated surgical instruments not cleaned correctly put both the staff and patients at risk of infections. Upon request, RN #2 was unable to provide or locate the surgical instruments' IFUs.

This was in contrast to the AAMI Sterile Processing guidelines, which stated those responsible for processing surgical instruments read, understand, and follow the manufacturer's written IFU for cleaning and sterilization. They recommended auditing the cleaning process to ensure compliance with the manufacturer's IFU and verifying personnel performing the cleaning had received documented training and demonstrated competency in the procedures

This was in contrast to the BD MEDICAL/CAREFUSION/V. MUELLER General Surgical Instrument IFU, which stated device cleaning must begin within two hours of use, with excess soil removed by rinsing or wiping as soon as possible. All devices had to be processed in a fully open position to ensure solution contact with all surfaces. The warnings highlighted improper use, care, or maintenance of the devices could cause serious injury and may render the instruments non-sterile, posing risks to both health care providers and patients.

This was in contrast to the KARL STORZ Surgical Instrument IFU, which stated failure to follow instructions, cautions, and warnings could result in serious consequences for the patient. For pre-cleaning, potable water was recommended to rinse and remove gross contamination immediately after use, with the water temperature not exceeding 113°F (45°C) to prevent coagulation of blood and proteins. After a procedure, instruments had to be wiped with a soft, lint-free cloth moistened with water to remove heavy soiling, and contaminated instruments were to be contained and transported with a similar cloth moistened with water or cleaning detergent.

ii. On 9/30/24 at 12:23 p.m., an interview was conducted with infection prevention program manager (Manager) #3. Manager #3 stated the Prepzyme Forever Wet was an enzymatic humectant spray used to prevent bioburden from drying on the surgical instruments, which would make them harder to clean. Manager #3 said the enzymatic humectant spray was colored blue, making it easy to detect whether the instruments had been sprayed correctly. Manager #3 stated untreated soiled instruments found on the counter were not best practice and went against the facility's policies. Manager #3 stated the facility followed AAMI guidelines for processing surgical instruments. Manager #3 stated surgical instruments not processed according to the IFU put patients at risk for infection.

iii. On 9/30/24 at 12:15 p.m., an interview was conducted with emergency department director (Director) #4. Director #4 stated the emergency department staff was responsible for cleaning and storing the surgical instruments before transporting it to SPD. Director #4 stated the soiled surgical instruments should not have been placed directly on the counter. Director #4 stated the soiled surgical instruments should have been pre-cleaned and sprayed with the enzymatic humectant spray according to the facility's policy. Director #4 stated when surgical instruments were not cleaned correctly, it placed patients at risk for surgical infection.