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Based on the manner and degree of the standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §485.640 Infection Prevention and Control and Antibiotic Stewardship Programs, was out of compliance.

C-1208 - The infection prevention and control includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and that the program also addresses any infection control issues identified by public health authorities. 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, national guidelines, and manufacturer instructions for use (IFU) in three out of three observations in the sterile processing department (SPD).

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, national guidelines, and manufacturer instructions for use (IFU) in three out of three observations in the sterile processing department (SPD).

Findings include:

Facility policy:

The Central Sterilization Infection Control policy read, pre-cleaning is performed to remove visible soil and debris from instruments using enzymatic detergent solution and brushes.

References:

According to the Association for the Advancement of Medical Instrumentation (AAMI) Sterile Processing - Knowledge, Skills, Competencies, provided by the facility, cleaning is the most important step in sterile processing; thorough cleaning removes most microorganisms and other organic material from contaminated items. Unless an item is clean, it cannot be effectively disinfected or sterilized. Any soil, no matter how little, can prevent disinfectant or sterilant from contacting the surface of an item. We can assess visible contamination by examining items carefully, but microorganisms are invisible so we consider items contaminated even when we cannot see any soil.

The best resource for determining how best to manage an item is the manufacturer's IFU. If a brush is too large, it will not fit into the lumen; if it is too small, it will not have complete contact with the lumen walls and, consequently, will not clean them thoroughly.

According to the Association of periOperative Registered Nurses (AORN) (2012-2023), Guidelines for Perioperative Practice: Instrument Cleaning, failure to clean, inspect, disinfect or sterilize an item may lead to transmission of pathogenic microorganism from a contaminated device and create risk for patient injury, including surgical site infection. All instruments opened onto the sterile field in the operating or procedure room should be cleaned and decontaminated whether or not they have been used. Contamination of unused instruments on the sterile field can occur without the occurrence being noticed.

The da Vinci Surgical System IFU read, the OR should wipe off excess soil. Insert luer tip fully into the primary flush port and twist to secure. Start water and begin to flush. While flushing, rotate the tip through its full range of motion. Flush and rotate for at least 20 seconds. Continue tip motion and flush until the water runs clear. Rinse entire instrument with cold running water for at least 60 seconds.

The INTEGRA LIFESCIENCE surgical instruments IFU read, immerse fully opened and/or disassembled instruments in an enzymatic solution. It is essential to keep the box locks and hinges open during any manual or automated cleaning process. Using a small clean hand-held brush, remove soil from all surfaces of the instrument while fully immersed in the solution. Remove the soil from the ratchets, jaws, tips, box locks, and/or hinge mechanism. The box lock and hinge portion of an instrument must be thoroughly cleaned after each use. Thoroughly rinse instruments by immersing in deionized water and wiping with a clean, soft cloth. Use an ultrasonic cleaner to remove soil from hard to reach surfaces such as grooves, crevices, lumens, instruments with moving parts, etc., after gross soil has been removed.

The BD MEDICAL/ CAREFUSION / V. MUELLER General Surgical Instrument IFU read, place the device In the open/relaxed position with flush port open. Completely Immerse the device in the detergent solution and allow It to soak for a minimum of five (5) minutes.

1. The facility failed to ensure surgical instruments were cleaned and processed in accordance with the facility policies and manufacturer's IFU. Specifically, the facility failed to manually clean and soak all surgical instruments in an enzymatic detergent prior to sterilization.

A. Observations

i. On 4/23/24 at 9:25 a.m., observations were conducted in the SPD. Observations revealed surgical instruments from the da Vinci tray being processed and cleaned by sterile processing technician (Tech) #1. The distal tips of the da Vinci surgical instruments were grossly soiled with dried blood and tissue. Tech #1 stated the instruments should have been pre-cleaned in the operating room (OR) prior to being transported to SPD. Tech #1 flushed the da Vinci instruments with tap water for 5 seconds but did not rotate the distal tips. Tech #1 placed the da Vinci instruments into the surgical sink filled with an enzymatic detergent solution and used a small pipe cleaner that did not fit the diameter of the lumen to manually clean the cannula. Tech #1 briefly ran the instrument under running water for three to five seconds and placed the instruments on a nearby counter.

ii. On 4/23/24 at 10:11 a.m., observations were conducted in the SPD. Observations revealed surgical instruments from the foot set tray being processed and cleaned by Tech #1. Tech #1 placed the hinged surgical instruments in a closed position into the surgical sink filled with an enzymatic detergent solution. Tech #1 removed the surgical instruments from the enzymatic detergent solution, brushed the tips of the instruments above the water line, missed the hinges and crevices, and placed the instruments in a nearby empty sink to be rinsed. Tech #1 then ran the instruments under tap water and placed the instruments in the automatic washer to be mechanically cleaned. Tech #1 stated the instruments did not require ultrasonic cleaning.

Further observation revealed Tech #1 only visually inspected multiple instruments during the manual cleaning process. Tech #1 stated it was standard practice to only manually brush instruments that were visibly soiled. Tech #1 stated instruments that were not used in the surgical case did not require to be manually cleaned.

iii. On 4/23/24 at 1:16 p.m., observations were conducted in the SPD. Observations revealed surgical instruments from the foot set tray being processed and cleaned by Tech #2. Tech #2 flushed the lumens of the instruments with 10 milliliters (ml) of enzymatic detergent solution, brushed the outside surfaces with a soft bristle brush without brushing the internal lumens, and placed the instrument in a nearby empty sink to be rinsed. Tech #2 removed the surgical instruments from the enzymatic detergent solution, brushed the tips of the instruments, missed the hinges and crevices, and placed the instruments in a nearby empty sink to be rinsed.

Further observation revealed Tech #2 only visually inspected multiple instruments during the manual cleaning process. Tech #2 stated they would only manually brush instruments that were visibly soiled.

iv. The observations conducted on 4/23/24 revealed surgical instruments were processed incorrectly per the facility's policy and manufacturer's IFU. Examples included:
Observations on 4/23/24 were in contrast to the Central Sterilization Infection Control policy which read, pre-cleaning was performed to remove visible soil and debris from instruments using enzymatic detergent solution and brushes.

Observations on 4/23/24 were in contrast to the AORN Guidelines for Perioperative Practice which read, all instruments opened onto the sterile field in the operating or procedure room should be cleaned and decontaminated whether or not they have been used.

Observations on 4/23/24 were in contrast to the daVinci IFU which read, the OR was to wipe off excess soil. The luer tip was inserted fully into the primary flush port and twisted to secure. While flushing, the tip was rotated through its full range of motion. Flushing and rotating were done for at least 20 seconds. Tip motion and flushing were continued until the water ran clear. The instrument was expected to be rinsed with cold running water for at least 60 seconds.

Observations on 4/23/24 were in contrast to the INTEGRA LIFESCIENCE surgical instruments IFU which read, the instruments were immersed fully opened and/or disassembled in an enzymatic solution. It was essential to keep the box locks and hinges open during any manual or automated cleaning process. A small clean hand-held brush was used to remove soil from all surfaces of the instrument while fully immersed in the solution. The soil was removed from the ratchets, jaws, tips, box locks, and/or hinge mechanism. The box lock and hinge portion of an instrument was thoroughly cleaned after each use. Instruments were thoroughly rinsed by immersing in deionized water and wiped clean with a soft cloth. An ultrasonic cleaner was used to remove soil from hard to reach surfaces such as grooves, crevices, lumens, instruments with moving parts, etc., after gross soil was removed.

Observations on 4/23/24 were in contrast to the BD MEDICAL/ CAREFUSION / V. MUELLER General Surgical Instrument IFU which read, the device was to be placed in the enzymatic solution in the open/relaxed position with flush port open.

B. Interviews

i. On 4/24/24 at 1:41 p.m., an interview was conducted with Tech #2. Tech #2 stated all surgical instruments were to have been manually washed after the procedure to remove any bioburden (organic material from a prior procedure). Tech #2 stated all surgical instruments with a lumen were expected to be flushed with enzymatic detergent solution and water. Tech #2 stated all of the instruments located in the surgical instrument casket were considered contaminated and were to have been manually cleaned and processed. Tech #2 stated when surgical instruments were not correctly manually cleaned after the procedure, the instruments could have been contaminated with bioburden and potentially caused a surgical infection.

This interview was in contrast to multiple observations of the SPD on 4/23/24 which revealed IFUs were not followed.

ii. On 4/29/24 at 1:11 p.m., an interview was conducted with Manager #3, Manager #3 stated each surgical instrument had an IFU on how to clean and process the instrument properly. Manager #3 stated it was important to follow the manufacturer's IFU to ensure all of the surgical instruments were processed properly. Manager #3 stated all instruments opened in the operating room were considered contaminated and should have been cleaned and decontaminated. Manager #3 stated when instruments were not cleaned correctly, there could have been bioburden left behind, and the instruments would not be sterilized after the steam sterilization cycle. Manager #3 stated surgical instruments not processed correctly could have caused a surgical infection or serious injury.

This interview was in contrast to multiple observations of the SPD on 4/23/24 which revealed IFUs were not followed.