HospitalInspections.org

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

C-1206 (a)(2) The infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the CAH and between the CAH and other healthcare settings; Based on observations, interviews and document review, the facility failed to employ methods to prevent the transmission of infections. Specifically, the facility failed to ensure manufacturers instructions for use (IFUs) were followed for the decontamination of surgical instruments.

Based on observations, interviews and document review, the facility failed to employ methods to prevent the transmission of infections. Specifically, the facility failed to ensure manufacturers instructions for use (IFUs) were followed for the decontamination of surgical instruments.

Findings include:

Facility policy:

The High Level Cleaning and Disinfection of Equipment/Instruments, revised 9/19 read, manufacturer's recommendations for cleaning equipment should be followed. Check the equipment's manufacturer's IFUs for disinfection of the piece of equipment.

References:

The 2021 Heart of the Rockies Regional Medical Center Infection Prevention Plan read, the infection prevention department contributes the prevention of procedure associated infections by supporting clinical practices recommended by professional organizations such as The Association of Operating Room Nurses (AORN), The Association of Professionals in Infection Control (APIC), The Institute of Healthcare Improvement (IHI), World Health Organization (WHO), and the CDC.

The Zimmer reusable devices instructions for care, cleaning, maintenance, and sterilization read, the manual provides information on the care, cleaning, disinfection, maintenance and sterilization of surgical instruments. The device instructions for use should always be consulted for specific recommendations or restrictions on processing within the health care setting.

When conducting combination cleaning and disinfection of instruments, completely submerge the instruments in an enzyme solution and allow to soak for ten minutes.

The Arthrex Surgical Instruments IFUs read, during preliminary cleaning, remove excess soil from devices by cleaning the surfaces with a sponge or brush for one minute. Rinse the devices for at least one minutes then immerse the devised in the cleaning solution inside an ultrasonic bath. While immersed in solution, brush the devices for two minutes using a soft bristle brush. After brushing, soak and sonicate for 10 minutes.

The International Association of Healthcare Central Service Material Management (IAHCSMM) technical manual, eighth edition read, following the IFUs is a critical component of the decontamination process. Failure to follow an IFU can result in a failed decontamination process and damage to instruments.

The AORN Guidelines for Perioperative Practice 2021 edition: Guidelines for Care and Cleaning of Surgical Instruments (Page 383) read, specific guidance for care and cleaning of each instrument can be found in the instruments manufacturer-validated IFUs. Failure to correctly clean and decontaminate surgical instruments used in invasive procedures can lead to subsequent failures in high level disinfection and sterilization which puts patients at risk for developing surgical site infection (SSIs).

The AORN Guidelines for Perioperative Practice 2021 edition: Guidelines for Care and Cleaning of Surgical Instruments, section 5. Processing before use (Page 391) read, provide the IFUs to personnel responsible for processing instruments in a format that they can read and understand. Instructions for use identify the processes necessary to achieve effective decontamination and sterility.

The AORN Guidelines for Perioperative Practice 2021 edition: Guidelines for Care and Cleaning of Surgical Instruments, section 9. Cleaning and Decontamination (Page 396) read, clean and decontaminate surgical instruments and equipment according to the manufacturers validated IFUs. Cleaning is the first step of decontamination and can be accomplished through manual and mechanical processes. The instrument equipment manufacturers have determined the manual or mechanical steps and processes necessary to effectively clean a device.

1. The facility failed to ensure surgical instruments were cleaned and decontaminated according to the manufacturer's IFUs.

A. Observations

i. On 7/26/21 at 10:05 a.m., observations were made of the sterile processing department (SPD) room. SPD technician (Tech) #1 was observed decontaminating Zimmer orthopedic instruments. Tech #1 soaked the surgical instruments for one minutes, then used a brush to remove gross soil and removed instruments from the enzymatic detergent solution.

Tech #1 stated the Zimmer orthopedic instruments were only required to soak in the solution for one minute.

B. Document Review

i. Review of the Zimmer orthopedic IFUs revealed instruments were to be completely submerged in an enzyme solution and needed to soak for ten minutes.

The review of the IFUs was in contrast to the observation of the instruments described above. Additionally, the observation was in contrast to national guidelines referenced above which read the manufacturer's IFUs were to be followed when instruments were decontaminated.

C. Interviews

i. On 7/26/21 at 3:04 p.m., SPD Technician (Tech) #4 was interviewed. Tech #4 stated he had helped train Tech #1 when she started at the facility. Tech #4 stated when decontamination of Arthrex surgical instruments, the instruments were to be taken apart and a brush was to be run through it. The instruments were then to be soaked for ten minutes then rinsed. Tech #4 stated he could not completely remember the exact steps for decontamination of the Arthrex instruments. Tech #4 stated he couldn't remember anything special about the Arthrex instruments and would need to consult the IFUs since they were not used often.

Review of documentation provided by the facility revealed Arthrex surgical instruments were used for total shoulder and rotator cuff repair procedures. Review of the surgical schedule revealed ten of the previously listed procedures were performed since 6/30/21. Tech #4's interview was in contrast to the surgery schedule review which showed the Arthrex instruments were used in frequent rotation at the facility.

ii. On 7/26/21 at 1:22 p.m., an interview was conducted with the Registered Nurse Surgical Manager (Manager) #2. Manager #2 stated Tech #1 had not followed the manufacturer's IFUs when soaking the Zimmer instruments. Manager #2 stated if the manufacturer's IFUs were not followed, then the instruments were not processed appropriately and there was a risk for infection.

iii. On 7/26/21 at 2:00 p.m., a second interview was conducted with Tech #1. Tech #1 stated she was taught how to clean Zimmer instruments two years prior when she first started her position. Tech #1 stated Manager #2 notified her she had conducted the decontamination process of the Zimmer instruments incorrectly. Tech #1 stated it was important to follow the manufacturer's IFUs in order to ensure gross soil was removed from instruments in order to prevent the spread of infection.

iv. On 7/26/21 # 3:37 p.m., an interview was conducted with Infection Prevention Manager (Manager) #3. Manager #3 stated she was responsible for surgical surveillance and tracking of post-operative SSIs. Manager #3 stated it was important to follow the IFUs to ensure proper cleaning had been performed. Manager #3 further stated if an instrument was not soaked for the amount of time as recommended by the IFUs, it was not guaranteed the instrument was disinfected.