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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, §482.21 Quality Assessment and Performance Improvement Program, was out of compliance.

A-0283 (b) & (c) QUALITY IMPROVEMENT ACTIVITIES (b) Program Data (2) [The hospital must use the data collected to - .....] (ii) Identify opportunities for improvement and changes that will lead to improvement. (c) Program Activities (1) The hospital must set priorities for its performance improvement activities that-- (i) Focus on high-risk, high-volume, or problem-prone areas; (ii) Consider the incidence, prevalence, and severity of problems in those areas; and (iii) Affect health outcomes, patient safety, and quality of care. (3) The hospital must take actions aimed at performance improvement and, after implementing those actions, the hospital must measure its success, and track performance to ensure that improvements are sustained. Based on observations, interviews and document reviews, the quality assessment and performance improvement (QAPI) program failed to assess the effect of the staffing shortage in the sterile processing department (SPD) to ensure patient safety. (Cross-reference A-0749)

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.42 Infection Prevention and Control and Antibiotic Stewardship Program, was out of compliance.

A-0749 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 follow manufacturer's instructions for use (IFU), national guidelines, and facility policy to ensure methods were in place to prevent and control the transmission of infections. Specifically, the facility failed to ensure staff reprocessed surgical instruments according to the manufacturer's IFU in four of four observations of the instrument reprocessing and sterilization process. Additionally, the facility failed to ensure staff were adequately trained to reprocess surgical instruments. (Cross-reference A-0283)

Based on observations, interviews and document reviews, the quality assessment and performance improvement (QAPI) program failed to assess the effect of the staffing shortage in the sterile processing department (SPD) to ensure patient safety. (Cross-reference A-0749)

Findings include:

References:

The Clinical Quality & Patient Safety Plan 2024-2025 read, the facility uses the Failure Mode and Effects Analysis (FMEA) or other risk assessment tools for proactive risk assessment. Failure modes are any errors or defects in a process that affects patients or staff and can be potential or actual. The purpose is to proactively take actions to eliminate or reduce failures, starting with the highest priority ones and to evaluate risk management priorities for mitigating known threat vulnerabilities.

The Association of periOperative Registered Nurses (AORN), 2025, Guidelines for Perioperative Practice, Guideline for Sterilization read, leadership should prioritize quality improvement efforts in accordance with regulatory requirements, industry guidelines, and concerns specific to the health care organization. Leaders should maintain a staffing plan for sterilization personnel.

The AORN, 2025, Guidelines for Perioperative Practice: Guideline for Quality Practice read, the QAPI program should facilitate the identification of problem areas and the development of patient safety indicators. These indicators are crucial in measuring the care provided to ensure a culture of patient safety. QAPI programs also assist personnel in evaluating and improving the quality of patient care and formulating plans for corrective action when concerns have been identified.

The American National Standards Institute/The Association for the Advancement of Medical Instrumentation (ANSI/AAMI) ST79, 2022, Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities, Prevention of Instrument Damage read, long delays in processing can result in the formation of tenacious and difficult-to-remove biofilm that will shield microorganisms from routine cleaning procedures and interfere with disinfection or sterilization.

The ANSI/AAMI ST79, 2022, Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities, Pre-cleaning and IFUs read, instruments should be maintained in a moist state before cleaning in order to prevent the drying of surgical debris onto or within them.

1. The facility failed to implement preventive measures to mitigate the decreased SPD staffing before it opened four new operating rooms (ORs) and increased the volume of surgical instruments reprocessed.

A. Observations

i. On 7/14/25 at 3:06 p.m., observations were conducted in the first-floor SPD decontamination area. Observations revealed 17 three-tiered stainless steel case carts (a metal cart with three shelves designed to hold and transport contaminated surgical instruments) in SPD. Each cart contained between 11 and 30 contaminated surgical instrument sets. The instrument sets were stacked both inside and on top of the case carts. Observations further revealed the surgical instrument sets were open to air and heavily soiled with dried blood and tissue. (Cross-reference A-0749)

ii. On 7/16/25 at 9:46 a.m., observations were conducted on the second-floor OR hallway and the soiled utility room (area where contaminated surgical instruments and sets were held after surgical procedures).

Observations revealed the OR hallway and the soiled utility room on the second-floor contained multiple three-tiered stainless steel case carts with contaminated surgical instrument sets. There were two case carts in the OR hallway and nine case carts in the soiled utility room.

During the observation, an interview was conducted with registered nurse (RN) #9. RN #9 stated SPD had ongoing reprocessing backlogs in the decontamination room. RN #9 stated the case carts with contaminated surgical instrument sets were placed in the soiled utility room and the OR hallway when SPD was backlogged.

iii. An additional observation was conducted in SPD on 7/21/25 at 3:57 p.m. At the time of the observation, 12 case carts with contaminated surgical instrument sets were in the decontamination room. The observation further revealed numerous contaminated instrument sets had remained in the decontamination room unprocessed for over 24 hours.

During the observation, SPD technician (Tech) #1 stated it was not uncommon for case carts with contaminated surgical instrument sets to remain unprocessed for greater than 24 hours. SPD Tech #1 further stated, at times, contaminated surgical instruments were not reprocessed for up to six days after the surgical procedure.

These observations were in contrast to the ANSI/AAMI ST79, which read, staff should have prevented the drying of biological material onto or within surgical instruments. Additionally, delayed reprocessing of contaminated surgical instruments caused biofilm formation and resulted in less effective disinfection and sterilization.

B. Document Review

i. A review of SPD huddle reports from 4/1/25 through 7/16/25 revealed delayed reprocessing of contaminated surgical instrument sets. Examples included:

a. On 4/3/25, 4/12/25, 4/16/25, 4/22/25, 4/29/25, and 4/30/25, there were 100 to 191 contaminated surgical instrument sets each day that remained unprocessed in SPD.

On 4/17/25 and 4/25/25, more than 250 contaminated surgical instrument sets remained unprocessed in SPD each day.

On 4/9/25, 4/10/25, 4/11/25, 4/18/25, 4/19/25, 4/23/25, and 4/24/25, the number of contaminated surgical instrument sets left unprocessed in SPD ranged from 309 to 461 sets per day.

b. According to the May 2025 SPD huddle reports, during the month of May, there were 20 days where the number of contaminated surgical instrument sets left unprocessed in the SPD exceeded 112. Specifically, on 5/9/25, 5/22/25, 5/24/25, 5/29/25, and 5/30/25, more than 250 contaminated surgical instrument sets remained unprocessed in SPD each day.

On 5/1/25, 5/2/25, 5/3/25, and 5/23/25, the number of contaminated surgical instrument sets left unprocessed in SPD ranged from 305 to 371 sets.

Lastly, on 5/10/25 and from 5/14/25 through 5/17/25, more than 400 contaminated instrument sets remained unprocessed, and the total surpassed 500 sets on 5/17/25.

c. According to the June 2025 SPD huddle report, unprocessed contaminated surgical instrument sets exceeded 120 on 18 days, including over 400 unprocessed instrument sets on 6/5/25 and 6/6/25.

d. Lastly, the July 2025 SPD huddle reports revealed nine days between 7/1/25 and 7/16/25 with over 110 contaminated surgical instrument sets unprocessed. Specifically, more than 300 sets remained unprocessed on 7/3/25 and 7/11/25, with the number of unprocessed instrument sets exceeding 400 on 7/10/25 and 7/16/25.

ii. A review of the 1/21/25 Board of Directors meeting minutes revealed additional ORs would be opened in June of 2025 and construction in SPD would begin to expand the department.

iii. Review of the OR and SPD Construction Request document provided by the facility on 7/21/25 revealed prior to the opening of additional ORs, SPD required 65.2 full-time equivalents (FTEs, represent the number of full-time employees and part-time employees combined to make a full-time equivalent). The required number of SPD technicians needed after the additional ORs opened increased to 85.2 FTEs, 20 more than previously required.

Upon request, the facility was unable to provide evidence SPD staffing levels had been increased to meet the post-expansion requirement.

C. Interviews

a. On 7/23/25 at 3:40 p.m., an interview was conducted with SPD Director (Director) #7. Director #7 stated the day to day activities and SPD staffing were reported to facility leadership daily in the SPD huddle report. Director #7 stated after the morning peri-operative huddle with VP #4, they emailed the SPD huddle report to VP #4. Director #7 stated the SPD huddle report listed the number of contaminated surgical instrument sets in SPD that had not been processed from prior surgical procedures. Director #7 stated VP #4 was informed of the staffing shortage in SPD, however, additional resources were not provided.

Director #7 stated patients could contract infections and their health could decompensate when surgical instruments were not cleaned according to the manufacturers instructions for use (MIFU).

b. On 7/23/25 at 4:18 p.m., an interview was conducted with chief quality officer (Officer) #11. Officer #11 stated the QAPI program had been unaware of the staffing shortage in SPD and did not monitor SPD staffing levels as a quality indicator (QI). Officer #11 stated the program also had not identified SPD staffing as a high-risk, high-volume, or problem-prone area that could impact patient safety. Officer #11 further stated prior to opening the additional ORs, the QAPI program had not evaluated how the lack of SPD staffing would affect patient health outcomes and quality of care.

c. On 7/21/25 at 4:29 p.m., an interview was conducted with vice president of perioperative and procedural services (VP) #4. VP #4 stated when the additional ORs were opened, they had been aware there was a staffing shortage in SPD. VP #4 stated the facility's pay rate for agency staff was lower than market rates, making it difficult to secure agency staff. VP #4 further stated the facility had not considered adjusting the surgical schedule to address the SPD staffing shortage.

The interview with VP #4 contrasted with Officer #11's interview. According to VP #4, when the additional ORs were opened they had been aware of the SPD staffing shortage, while Officer #11's interview indicated the QAPI program had been unaware of the SPD staffing shortage, and had not evaluated its potential impact on patient safety or quality of care.

These interviews were also in contrast to AORN guidelines which stated, the facility should have maintained and implemented a staffing plan for the SPD, and identified problem areas within the SPD to guide corrective actions and improve patient care and safety. Additionally, the interviews contrasted with the facility's Clinical Quality & Patient Safety Plan 2024-2025. According to the plan, facility leadership should have acted on the SPD staffing shortage and implemented corrective measures to mitigate and prevent risks to patient safety.

Based on observations, document reviews, and interviews, the facility failed to follow manufacturer's instructions for use (IFU), national guidelines, and facility policy to ensure methods were in place to prevent and control the transmission of infections. Specifically, the facility failed to ensure staff reprocessed surgical instruments according to the manufacturer's IFU in four of four observations of the instrument reprocessing and sterilization process. Additionally, the facility failed to ensure staff were adequately trained to reprocess surgical instruments. (Cross-reference A-0283)

Findings include:

Facility policies:

The Sterile Processing Policy read, pre-cleaning, decontamination, and sterilization processes will be performed in alignment with manufacturer's instructions for use (MIFU) and follow evidence-based guidelines. Point of Use should be performed to remove all visible debris or bioburden (microbial contamination on a medical device or product). A manufacturer and/or facility approved product may be used to aid in removing visible debris or bioburden as needed or required per MIFU.

The Compliance Education and Training Policy read, the need for ongoing specialized training will be identified by the Team Member's leadership and will be coordinated and monitored for completion by such leadership. In addition, Compliance leadership may also identify a training need and encourage and/or require its completion.

The Competency Policy read, all mechanisms for validating competency must be documented, dated, and maintained in the employee's departmental file or unit file. Department Managers are responsible for ensuring that staff competence is assessed and documented at least every three years or more frequently as required by organization policy or in accordance with law and regulation. All members of the department should continuously maintain satisfactory work performance levels, maintaining comprehensive documentation to support and demonstrate employee competency.

References:

According to the American National Standards Institute (ANSI)/Association for the Advancement of Medical Instrumentation (AAMI), Pre-cleaning and IFUs - Instruments, 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 ANSI/AAMI Sterile Processing - Knowledge, Skills, Competencies, 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.

According to ANSI/AAMI Sterile Processing - Education and training, sterile processing personnel should receive an initial orientation covering all tasks performed in the sterile processing area, including orientation in policies and procedures regarding infection prevention and control, safety, attire, personal hygiene, and compliance with state and federal regulations. Sterile processing personnel should receive continuing education at regular intervals to review and update knowledge and skills and to maintain competency and certification.

The Association of periOperative Registered Nurses (AORN) Guidelines for Perioperative Practice, Instrument Cleaning, 2020, read, failure to correctly clean and decontaminate surgical instruments and other medical devices used in invasive procedures can lead to subsequent failures in high-level disinfection and sterilization that put patients at risk for developing a surgical site infection (SSI). Approximately 50% of SSIs are preventable with the use of evidence-based strategies. Effective decontamination and subsequent sterilization are essential SSI prevention measures.

Begin preparation for instrument decontamination at the point of use. Moistening and removing gross soil at the point of use can help prevent organic material and debris from drying on instruments. Organic material and debris are more difficult to remove from surgical instruments when they are allowed to dry, and residual soil can affect the efficacy of subsequent disinfection and sterilization processes.

Use brushes or other items that meet the specifications (eg, diameter, length, materials) in the instrument or medical device manufacturer's IFU to clean crevices and lumens. Soil can become lodged in crevices, box locks, lumens, and other areas of instruments. Perform brushing under the surface of the water during manual cleaning. Brushing under water reduces the risk of aerosolization of chemicals and contaminants during manual cleaning.

The Integra Lifesciences Surgical Instruments IFU read, Precleaning: Remove gross debris from surgical instruments with a lap sponge and sterile water routinely during the procedure to prevent drying on of blood and body fluids, etc. It is important to rinse instruments that have been exposed to blood and saline solution before these substances dry.

Maintain moisture: Immediately after the surgical procedure, place the instruments in an instrument tray/container and cover with a towel moistened with sterile distilled water. Foam, spray or gel products, specifically intended for use with surgical instruments, are available to keep the soil moist.

Cleaning: To prevent the formation of biofilm, cleaning should occur as soon as possible after instrumentation is used. Biofilm is an accumulation of a biomass of bacteria and extracellular material that tightly adheres itself to the surface of the instruments. It cannot be easily removed, and protects microorganisms from being easily removed by ordinary cleaning/decontamination methods used in hospitals.

Enzymatic Soak: Immerse fully opened and/or disassembled instruments in an enzymatic solution, specific for use with surgical instruments. Prepare the solution and use per the enzymatic manufacturer's recommendations, paying special attention to instructions for correct dilution, temperature and soak time.

Cleaning Instruments: 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. A build-up of soil, debris, lubricants, etc. in these areas will make it difficult to use the instrument and eventually irreparably damage it. Vigorously flush channels with the cleaning solution. Manual cleaning should remove all visible residue. It is essential to keep the box locks and hinges open during any manual or automated cleaning process.

Rinse: Remove from the enzymatic soak after the time period recommended by the enzymatic manufacturer and rinse thoroughly with tap water. Flush lumens until rinse water runs clear.

The Symmetry Surgical Inc. surgical instruments IFU read, completely submerge instruments in the enzymatic solution and gently shake them to remove trapped bubbles. Actuate (open and close) instruments with hinges or moving parts to ensure contact of the solution with all surfaces. Lumens, blind holes and cannulas should be flushed with a syringe to remove bubbles and ensure contact of the solution with all instrument surfaces.

Soak instruments for a minimum of 10 minutes. While soaking, scrub surfaces using a soft nylon-bristled brush until all visible soil has been removed. Actuate moveable mechanisms. Particular attention should be given to crevices, hinged joints, box locks, instrument teeth, rough surfaces and areas with moving components or springs.

Remove the instruments from the enzymatic solution and rinse in tap water for a minimum of one minute. Actuate all moveable and hinged parts while rinsing. Thoroughly and aggressively flush lumens, holes, cannulas and other difficult to access areas.

The Pre-Klenz IFU read, apply at point of use, Pre-Klenz Instrument Transport Gel initiates pre-cleaning, keeps surgical soils moist, and controls odors. Spray evenly over the surgical tray to ensure soils are covered. Transport instruments for further processing.

1. The facility failed to pre-clean and manually clean all surgical instruments in an enzymatic detergent prior to sterilization in accordance with facility polices, manufacturers' IFUs, and national guidelines.

A. Observations

i. On 7/14/25 at 3:06 p.m., observations were conducted in the sterile processing department (SPD). Observations revealed 17 three-tiered stainless steel case carts with contaminated surgical instruments were spread throughout the SPD, making it difficult to navigate throughout the department. Further observations revealed over 30 contaminated surgical trays stacked on top of the case carts that were open to air. Additional observations revealed a surgical case cart with a kidney transplant surgical tray. Surgical instruments were grossly soiled with dried blood and tissue. Further observations revealed surgical instruments were dry and had not been precleaned.

ii. On 7/14/25 at 3:15 p.m., observations were conducted in the SPD. Observations revealed a surgical dilation and curettage (D&C, surgical procedure where the cervix was dilated and the lining of the uterus scraped) set which contained visibly soiled surgical instruments. Further observations revealed sterile processing technician (Tech) #1 had sprayed the instruments with Pre-Klenz (a gel based solution used to treat surgical instruments at the point of use). Tech #1 stated the surgical instruments were not pre-cleaned in the operating room (OR). Tech #1 stated the surgical instruments were grossly soiled with dried blood and tissue. Tech #1 stated the staff failed to spray the instruments with Pre-Klenz prior to being transported to the SPD. Tech #1 stated if the surgical instruments were not pre-cleaned, the bioburden could harden, making it difficult to clean. Tech #1 stated hardened bioburden in areas difficult to visualize, such as lumens and hinge boxes, could be missed, and the instrument would not be able to be cleaned. Tech #1 stated if the instruments were not cleaned appropriately they would not be able to be sterilized and could cause a surgical site infection (SSI).

Observations on 7/14/25 at 3:15 p.m. were in contrast to the Pre-Klenz IFU which stated, staff should have applied the product at the point of use. Pre-Klenz Instrument Transport Gel initiated pre-cleaning, kept surgical soils moist, and controlled odors. Staff should have sprayed the gel evenly over the surgical tray to ensure complete soil coverage and transported the instruments for further processing.

Observations on 7/14/25 at 3:06 p.m. and 3:15 p.m. were in contrast to the Sterile Processing policy which stated, staff should have performed pre-cleaning, decontamination, and sterilization processes in alignment with MIFU and followed evidence-based guidelines. Staff should have performed Point of Use cleaning to remove all visible debris or bioburden.

Observations on 7/14/25 at 3:06 p.m. and 3:15 p.m. were also in contrast to the Integra Lifesciences Surgical Instruments IFU which stated, staff should have removed gross debris from surgical instruments with a lap sponge and sterile water throughout the procedure to prevent blood and body fluids from drying on the instruments. Staff should have rinsed instruments exposed to blood and saline solution before the substances dried. Immediately after the procedure, staff should have placed the instruments in a tray or container and covered them with a towel moistened with sterile distilled water. Foam, spray, or gel products, specifically intended for use with surgical instruments, should have been used to keep the soil moist.

Additionally, observations on 7/14/25 at 3:06 p.m. and 3:15 p.m. were in contrast to ANSI/AAMI Guidelines on Pre-cleaning and IFUs, where staff should have precleaned instruments immediately after use. They should have removed gross debris and flushed instrument lumens with sterile distilled water as recommended by the manufacturer. Instruments should have been maintained in a moist state before cleaning to prevent surgical debris from drying on or inside them.

Furthermore, observations on 7/14/25 at 3:06 p.m. and 3:15 p.m. were in contrast to AORN Guidelines for Perioperative Practice which stated, staff should have prepared instruments for decontamination at the point of use. They should have moistened and removed gross soil to help prevent organic material and debris from drying on the instruments. When allowed to dry, organic material and debris became more difficult to remove and interfered with the effectiveness of subsequent disinfection and sterilization processes.

iii. On 7/14/25 at 3:23 p.m., observations were conducted in the SPD. Observations revealed surgical instruments from the D&C surgical instrument set being processed and cleaned by Tech #3. Tech #3 placed closed-hinged instruments into the surgical sink with an enzymatic detergent solution before pre-rinsing them. During manual cleaning, Tech #3 only visually inspected multiple instruments, brushed only the front side of the hinged instruments, and did not actuate the hinges while cleaning. Additionally, Tech #3 brushed the instruments above the water line. During the observation a dilator (device that widens a body opening) was observed to be tarnished with visible rust, Tech #3 continued to reprocess the instrument and did not remove the instrument from the tray to be repaired or replaced. Tech #3 removed the instruments from the sink without performing a final rinse and placed them on a nearby rack to dry. During the observation, Tech #3 stated they followed the manufacturer's IFU when cleaning surgical instruments to prevent SSIs.

iv. On 7/14/25 at 3:40 p.m., observations were conducted in the SPD. Observations revealed surgical instruments from the laminectomy (a surgical procedure that involves removing part or all of the lamina, the bony arch on the back of the vertebra, to relieve pressure on the spinal cord or nerves) set being processed and cleaned by Tech #2. Further observations revealed visibly soiled surgical instruments with dried bioburden. Tech #2 placed closed-hinged instruments into the surgical sink, which contained an enzymatic detergent solution, without pre-rinsing. During manual cleaning, Tech #2 only visually inspected the instruments and did not brush them to remove visible bioburden. Tech #2 opened visibly soiled hinged instruments on a stringer (device used to organize and prepare surgical instruments for cleaning and sterilization), briefly placed them in the enzymatic detergent, failed to manually clean or rinse them, and placed them in a nearby surgical tray. Further observations revealed Tech #2 picked up a Blount Mallet (a type of orthopedic surgical mallet) from the counter, briefly placed the instrument into an enzymatic detergent solution, and then placed the instrument on a nearby rack.

All observations conducted on 7/14/25 were in contrast to the Sterile Processing Policy which stated, staff should have performed pre-cleaning, decontamination, and sterilization processes in alignment with MIFU and followed evidence-based guidelines. Staff should have also performed point-of-use cleaning to remove all visible debris and bioburden. Manufacturer or facility-approved products should have been used to aid in removing debris or bioburden as needed or as required by MIFU.

The observations on 7/14/25 were also in contrast to the ANSI/AAMI Sterile Processing - Knowledge, Skills, Competencies which stated, cleaning was the most important step in sterile processing. Thorough cleaning removed most microorganisms and other organic material from contaminated items. Unless an item had been cleaned, it could not be effectively disinfected or sterilized. Any soil, no matter how little, could prevent disinfectant or sterilant from contacting the surface of an item. Staff could assess visible contamination by examining items carefully, but microorganisms were invisible, so items were considered contaminated even when soil could not be seen. The best resource for determining how best to manage an item was the manufacturer's IFU.

Observations on 7/14/25 were in contrast to the AORN Guidelines for Perioperative Practice: Instrument Cleaning which stated, failure to correctly clean and decontaminate surgical instruments and other medical devices used in invasive procedures could lead to subsequent failures in high-level disinfection and sterilization that put patients at risk for developing a SSI. Approximately 50% of SSIs were preventable with the use of evidence-based strategies. Effective decontamination and subsequent sterilization were essential SSI prevention measures. Brushes or other items that met the specifications (e.g., diameter, length, materials) in the instrument or medical device manufacturer's IFU to clean crevices and lumens should have been used. Soil could become lodged in crevices, box locks, lumens, and other areas of instruments. Instruments should have been brushed under the surface of the water during manual cleaning to reduce the risk of aerosolization of chemicals and contaminants.

Additionally, observations on 7/14/25 were in contrast to the Integra Lifesciences Surgical Instruments IFU which stated, after the surgical procedure, instruments should have been placed in a covered container with a towel moistened with sterile distilled water. Foam, spray, or gel products, specifically intended for use with surgical instruments, should have been used to keep the soil moist.

To prevent the formation of biofilm, cleaning should have occurred as soon as possible after instrumentation was used. Biofilm was an accumulation of a biomass of bacteria and extracellular material that tightly adhered to the surface of the instruments, and could not be easily removed.

Instruments should have been immersed fully opened and/or disassembled in an enzymatic solution, specific for use with surgical instruments. The solution should have been prepared and used per the enzymatic manufacturer's recommendations, with special attention to instructions for correct dilution, temperature and soak time.

Staff should have used a small, clean hand-held brush and removed soil from all surfaces of the instrument while fully immersed in the solution. Staff should have also removed the soil from the ratchets, jaws, tips, box locks, and/or hinge mechanism. The box lock and hinge portion of an instrument should have been thoroughly cleaned after each use. Additionally, staff should have vigorously flushed channels with the cleaning solution. Manual cleaning should have removed all visible residue. It was essential to keep the box locks and hinges open during any manual or automated cleaning process.

Staff should have removed instruments from the enzymatic soak after the time period recommended by the enzymatic manufacturer and rinsed thoroughly with tap water. Lumens should have been rinsed until the water ran clear.

Furthermore, the observations conducted on 7/14/25 were in contrast to the Symmetry Surgical Inc. surgical instruments IFU which stated, instruments should have been completely submerged in the enzymatic solution and gently shook to remove trapped bubbles. Staff should have actuated instruments with hinges or moving parts to ensure the solution came into contact with all surfaces. Lumens, blind holes and cannulas should have been flushed with a syringe to remove bubbles to ensure contact of the solution with all instrument surfaces.

Staff should have soaked instruments for a minimum of 10 minutes. While the instruments soaked, surfaces should have been scrubbed with a soft nylon-bristled brush until all visible soil had been removed. Particular attention should have been given to crevices, hinged joints, box locks, instrument teeth, rough surfaces and areas with moving components or springs.

The instruments should have been removed from the enzymatic solution and rinsed in tap water for a minimum of one minute. All moveable and hinged parts should have been actuated while rinsing. Lumens, holes, cannulas, and other difficult to access areas should have been thoroughly and aggressively flushed.

In addition, the observations conducted on 7/14/25 were in contrast to the Pre-Klenz IFU which stated to apply at point of use. Pre-Klenz Instrument Transport Gel initiated pre-cleaning, kept surgical soils moist, and controlled odors. Staff should have sprayed the surgical tray evenly to ensure soils were covered. Instruments should have been transported for further processing.

B. Medical Record Review

i. Medical record review revealed, Patient #2 was admitted on 7/9/25 for a microscopic direct laryngoscopy (surgical procedure to examine the vocal cords using a microscope) for magnification, with an attempted fat injection. Review of the operative note revealed the procedure was delayed for several hours while staff evaluated, cleaned, and assembled the Bruening syringe (a specialized syringe used for vocal cord fat injection). Staff took the patient to the OR and administered general anesthesia (medically induced loss of consciousness that renders a patient unarousable, even by painful stimuli). They attached the Bruening syringe and attempted to use the first needle, which was severely bent. The second needle was missing entirely. They attached the third needle and attempted to inject fat, but the fat did not pass through and could not be cleared. Additional attempts to find a compatible needle were unsuccessful. Staff injected Juvederm XL (injectable substance used to add volume and fullness to the skin) into the patient's vocal fold. After the surgery, Provider #10 notified risk management and the patient's family about the defective equipment and the inability to perform the procedure.

C. Interviews

i. Interviews conducted with staff over the course of the survey between 7/14/25 and 7/24/25 revealed the following:

a. An interview was conducted with Tech #5. Tech #5 stated the surgical instruments had to be pre-cleaned in the OR in accordance with the IFU before being transported to SPD. Tech #5 stated when instruments were not pre-cleaned, the bioburden hardened, and it became difficult to reprocess. Tech #5 stated hardened bioburden in areas difficult to visualize, such as lumens and hinge boxes, could be missed, and the instrument would not be able to be cleaned.

This was in contrast to multiple observations of the SPD on 7/14/25, which revealed surgical instrument IFUs were not followed.

Tech #5 also stated it was possible for surgical instruments to remain unprocessed for up to six days due to the high volume of surgical instruments that needed to be processed. Tech #5 stated the staff were trained to respray the surgical instruments every 72 hours to help prevent the bioburden from hardening. Tech #5 stated if the instruments were not cleaned appropriately, they would not be able to be sterilized and could cause an SSI.

b. An interview was conducted with sterile processing director (Director) #7. Director #7 stated each surgical instrument had an IFU which outlined proper cleaning and processing instructions. Director #7 stated it was important to follow the manufacturer's IFU to ensure adequate instrument processing. Director #7 stated if staff failed to follow the IFU, the facility could not ensure the instruments were cleaned appropriately or sterilized. Director #7 stated OR staff precleaned instruments in the operating room to remove gross bioburden and sprayed them with Pre-Klenz.

This was in contrast to the observation conducted on 7/14/25 at 3:06 p.m., which revealed surgical instruments in the kidney transplant tray were dry, grossly soiled with dried blood and tissue, and had not been precleaned.

Director #7 also stated SPD staff resprayed instruments with Pre-Klenz every 72 hours because reprocessing a large number of surgical instruments brought to the SPD often took days. Director #7 stated each time the staff sprayed the instruments, it reset the 72-hour window for processing.

This was in contrast to the Pre-Klenz IFU which stated, it was to be applied at point of use. There was no evidence in the IFU which indicated respraying the surgical instruments reset the 72-hour window for processing.

Director #7 stated if staff did not clean instruments correctly, bioburden could remain, which would prevent sterilization during the steam sterilization cycle. Director #7 stated improperly processed instruments could cause SSIs or serious injury.

An additional interview was conducted with Director #7. Director #7 stated the number of direct-hire SPD staff declined over the past year, and the facility prohibited adding agency staff. Director #7 stated, as a result, contaminated surgical instrument sets were not reprocessed in a timely manner and often remained unprocessed overnight. Director #7 stated this information had been communicated to facility leadership daily through the SPD huddle report, which Director #7 stated they emailed to the vice president of perioperative and procedural services (VP) #4. (Cross-reference A-0283)

2. The facility failed to ensure staff received ongoing training and competencies in the SPD to handle and reprocess surgical instruments.

A. Document Review

i. Personnel file review for Tech #12 revealed an initial competency assessment tool (ICAT) used to validate knowledge in the SPD. Tech #12 was deemed competent to process surgical instruments on 7/19/23. Further review of the personnel file showed no evidence of continuing education in surgical instrument reprocessing and sterilizing training.

ii. Review of Tech #13's ICAT revealed Tech #13 was deemed competent to process surgical instruments on 4/4/23. Further review of the personnel file showed no evidence of continuing education in surgical instrument reprocessing and sterilizing training.

iii. Review of Tech #14's ICAT revealed Tech #14 was deemed competent to process surgical instruments on 6/19/23. Further review of the personnel file showed no evidence of continuing education in surgical instrument reprocessing and sterilizing training.

iv. Review of Tech #15's ICAT revealed Tech #15 was deemed competent to process surgical instruments on 12/20/22. Further review of the personnel file showed no evidence of continuing education in surgical instrument reprocessing and sterilizing training.

Upon request on 7/23/25 and 7/24/25, the facility was unable to provide any continuing education or revalidation of competency for Tech #12, Tech #13, Tech #14, or Tech #15.

This was in contrast to the Competency Policy which stated, staff documented, dated, and maintained all mechanisms for validating competency in the employee's departmental or unit file. Department Managers should have ensured staff competence was assessed and documented at least every three years or more frequently, as required by organizational policy or applicable laws and regulations. All department members continuously maintained satisfactory work performance and comprehensive documentation to support and demonstrate employee competency.

This was also in contrast to the Compliance Education and Training Policy which stated, team members' leadership should have identified the need for ongoing specialized training and coordinated and monitored its completion. Compliance leadership also should have identified training needs and encouraged or required their completion.

Furthermore, this was in contrast to the ANSI/AAMI Sterile Processing - Education and Training which stated, sterile processing personnel should have received continuing education at regular intervals to review and update their knowledge and skills and to maintain competency and certification.

B. Interviews

i. Interviews conducted with staff over the course of the survey between 7/14/25 and 7/24/25 revealed the following:

a. An interview was conducted with Tech #5. Tech #5 stated they were trained on facility polices and performed competencies on how to reprocess and sterilize surgical instruments when they were hired. Tech #5 stated prior to the survey, they had not been retrained or reassessed for competency since they were hired. Tech #5 stated it was important to stay up to date on how to reprocess surgical equipment to prevent SSIs.

b. An interview was conducted with Director #7. Director #7 stated staff received training on decontamination and sterilization policies and procedures, and their initial competencies were verified and documented on the ICAT. Director #7 stated vendors periodically provided additional training throughout the year. Director #7 stated SPD supervisors reported observing staff during instrument reprocessing; however, they could not provide whether staff competencies were regularly validated and documented.

This was in contrast to the Competency Policy, Compliance Education and Training Policy, and the ANSI/AAMI Sterile Processing - Education and Training national guidelines, as referenced above.