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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 follow 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 manufacturer IFU in four of four observations of the instrument reprocessing and sterilization process. Additionally, the facility failed to ensure expired surgical supplies were not readily available for patient use and were discarded once expired. The failure was observed in two of three observations of the operating room (OR).

Based on observations, document reviews, and interviews, the facility failed to follow 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 manufacturer IFU in four of four observations of the instrument reprocessing and sterilization process. Additionally, the facility failed to ensure expired surgical supplies were not readily available for patient use and were discarded once expired. The failure was observed in two of three observations of the operating room (OR).

Findings include:

Facility policies:

The Sterile Processing Policy read, all medical devices requiring specific methods of decontamination, disinfection, sterilization, transportation, and storage will follow all current manufacturer's instructions for use (IFU), current standards and practice including but not limited to the Association for the Advancement of Medical Instrumentation (AAMI) and the Association of Operating Room Nurses (AORN), federal and state regulations, evidence based practice or facility specific policies and procedures. Point of use cleaning should be performed to remove all visible debris or bioburden.

The Clean and Sterile Supply Storage in Clinical Areas Policy read, sterile and clean supplies will be stored in a manner that will protect them from contamination until used. Supply inventory must be inspected at least monthly for expiration dates. Items whose posted expiration dates have passed must be discarded or undergo total reprocessing if originally prepared by the Hospital Sterile Processing Department.

References:

According to the Association for the Advancement of Medical Instrumentation (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.

The 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 deemed to be 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. During the procedure, remove gross soil from instrument surfaces with a sterile radiopaque surgical sponge moistened with sterile water. 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. Use of a brush intended for these difficult-to-clean areas facilitates the removal of soil. To clean lumens, use brushes that contact the inner surface of the lumen without collapsing. Brushes with bristles that are too small or too large in diameter can prevent thorough cleaning. 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.

A thermometer is used to monitor that cleaning solution temperatures are within the correct range as described in the cleaning solution manufacturer's IFU.

The AESCULAP / B. BRAUN Surgical Instruments IFU read, point of use care; remove gross debris with a disposable low or non-linting wipe moistened with water and flush lumens with water. Keep instruments moist between point of use and decontamination.

Pre-Rinse: Use unheated utility/tap water to rinse the instruments for a minimum of 1.5 minutes to remove gross debris. Continue to rinse with unheated utility/tap water until gross debris is removed.

Cleaning: Move all parts that can be moved during manual cleaning to allow cleaning solution and brushing action to reach all surfaces.

Brushing and flushing: use a soft or medium non-metal bristle brush. Brush all surfaces until visibly clean. Brush difficult to reach areas such as lumens/cannulas, special rotating areas and hidden surfaces 4 times (back & forth action - 1 time). Moving parts should be moved during their cleaning to reach all surfaces. Flush lumens 4 times with a minimum of 20ml cleaning solution using a syringe or a jet pistol type flusher. Repeat flushing with utility water a minimum of 3 times.

The Prolystica 2X Concentrate Enzymatic Presoak and Cleaner IFU read, the cleaner is low foaming enzymatic presoak and cleaner for removal of protein, carbohydrate and lipid-based soils on surgical instruments and medical devices. Activity increases as the water temperature increases. Clean a minimum of one to five minutes. Cleaning time may be longer with dried on proteinaceous materials or if lower temperatures are used. Do not exceed 130°F (55°C). After cleaning, rinse thoroughly or transfer to next cleaning operation.

1. The facility failed to ensure surgical instruments were pre-cleaned and reprocessed in accordance with facility policies and manufacturers' IFU. Specifically, the facility failed to pre-clean all surgical instruments prior to being manually cleaned. Additionally, the facility failed to follow the enzymatic detergent IFU and ensure the water temperature was within range.

A. Observations

i. On 1/15/25 at 4:38 p.m., observations were conducted in the sterile processing department (SPD). Observations revealed the Steris dosing system temperature probe hanging outside of the surgical sink. Further observations revealed sterile processing department (Tech) #1 dipped their gloved hands in and out of the water several times. Tech #1 stated they had been in their position for a while, and knew what the water temperature should feel like. Tech #1 was unable to provide the recommended water temperature range per the enzymatic solution IFU.

ii. On 1/16/25 at 1:15 p.m., observations were conducted in the operating room (OR) #2. Observations revealed certified surgical technologist (Tech) #2 precleaning surgical instruments from the orthopedic foot and ankle surgical set tray. Further observations revealed gross bioburden (organic material such as tissue, blood, or bone) left behind from the procedure. Tech #2 stated they followed the manufacturer IFU when they pre-cleaned surgical instruments. Tech #2 stated it was important to follow the manufacturer's IFU to clean and process the instruments to prevent an SSI.

iii. On 1/16/25 at 2:25 p.m., observations were conducted in the SPD. Observations revealed surgical instruments from the orthopedic foot and ankle surgical set tray being processed and cleaned by Tech #3. The distal tips of two forceps were grossly soiled with dried blood and tissue. Tech #3 stated the instruments should have been pre-cleaned in the OR prior to being transported to SPD.

Observations further revealed the Steris dosing system temperature probe hanging outside of the surgical sink.

Further observations revealed Tech #3 pre-rinsed the surgical instruments, placed them into the surgical sink filled with an enzymatic detergent solution, and used a small pipe cleaner that did not fit the diameter of the suction tip lumen to manually clean the cannula. Tech #3 brushed the lumen two times and flushed the lumen with 10ml of enzymatic solution. Tech #3 brushed the front side of the hinged instruments and did not actuate the hinges while cleaning.

Further observation revealed Tech #3 only visually inspected multiple instruments during the manual cleaning process. Tech #3 ran the instruments under running water for three to five seconds and placed the instruments on a nearby counter.

iv. On 1/16/25 at 2:45 p.m., observations were conducted in the SPD. Observations revealed surgical instruments from the cranial facial surgical set tray being processed and cleaned by Tech #4. Observations revealed the Steris dosing system temperature probe hanging outside of the surgical sink.

Further observations revealed Tech #4 placed the surgical instruments into the surgical sink filled with an enzymatic detergent solution prior to pre-rinsing the instruments. Tech #4 used a small pipe cleaner that did not fit the diameter of the suction tip lumen to manually clean the cannula. Tech #4 brushed the lumen two times and flushed the lumen with 20ml of enzymatic solution. Tech #4 brushed the hinged instruments above the water line and did not actuate the hinges while cleaning.

The observations on 1/15/25 and 1/16/25 were in contrast to the AAMI Sterile Processing - Knowledge, Skills, Competencies which read, the manufacturer's IFU was the best resource for determining how to manage an item effectively.

The observations on 1/15/25 and 1/16/25 were in contrast to the AORN Guidelines for Perioperative Practice: Instrument Cleaning which read, staff began preparation for instrument decontamination at the point of use. They moistened and removed gross soil at the point of use to help prevent organic material and debris from drying on instruments. During procedures, they removed gross soil from instrument surfaces using a sterile radiopaque surgical sponge moistened with sterile water.

Staff used brushes or other items that met the specifications in the instrument or medical device manufacturer's IFU to clean crevices and lumens. To clean lumens, staff used brushes that contacted the inner surface of the lumen without collapsing. Brushes with bristles that were too small or too large in diameter prevented thorough cleaning. Staff brushed under the surface of water during manual cleaning to reduce the risk of aerosolizing chemicals and contaminants.

Staff used a thermometer to monitor that cleaning solution temperatures stayed within the correct range as described in the cleaning solution manufacturer's IFU.

The observations on 1/15/25 and 1/16/25 were in contrast to the AESCULAP / B. BRAUN Surgical Instruments IFU which read, Staff removed gross debris with a disposable low or non-linting wipe moistened with water and flushed lumens with water. They kept instruments moist between the point of use and decontamination.
For pre-rinsing, staff used unheated utility or tap water to rinse the instruments for a minimum of 1.5 minutes to remove gross debris. They continued rinsing with unheated utility or tap water until all gross debris was removed.
Staff used a soft or medium non-metal bristle brush to clean all surfaces until visibly clean. They brushed difficult-to-reach areas, such as lumens, cannulas, special rotating areas, and hidden surfaces, four times with a back-and-forth motion. Moving parts were manipulated during cleaning to ensure all surfaces were reached. Staff flushed lumens four times using a minimum of 20ml cleaning solution with a syringe or a jet pistol-type flusher. They then repeated flushing with utility water a minimum of three times.

The observations of Tech #1 were in contrast to the Prolystica 2X Concentrate Enzymatic Presoak and Cleaner which read, cleaning time may be longer with dried-on proteinaceous materials or if lower temperatures are used. Do not exceed 130°F (55°C).

B. Interviews

i. On 1/21/25 at 3:02 p.m., 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 if the surgical instruments were not pre-cleaned, the bioburden could harden, making it difficult to clean. 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. Tech #5 stated if the instruments were not cleaned appropriately, they would not be able to be sterilized and could cause an SSI.

Tech #5 stated if the water temperature had gone over the recommended temperature in the Prolystica Enzymatic IFU, the enzymatic may not have worked properly. Tech #5 stated that if the enzymatic detergent was not used per the IFU, the instruments may not have been cleaned properly and it could have caused a surgical infection.

Tech #5 stated all surgical instruments were to have been manually washed after the procedure to remove any bioburden. Tech #5 stated all of the instruments located in the surgical instrument casket were considered contaminated and were to have been manually cleaned and processed. Tech #5 stated it was important to use the correct size brush when lumen instruments. Tech #5 stated if the brush was too small, it would not come into contact with all sides of the lumen, and they could miss bioburbon in the cannula. Tech #5 stated when surgical instruments were not correctly manually cleaned after the procedure, the instruments could have been contaminated with bioburden and potentially caused an SSI.

ii. On 1/23/25 at 4:38 p.m., an interview was conducted with SPD Manager #6. Manager #6 stated the facility followed AAMI and AORN guidelines in the SPD. Manager #6 stated all surgical instruments should have been cleaned per the manufacturer's IFU. Manager #6 stated surgical instruments should have been precleaned in the OR to remove visible contamination. Manager #6 stated if surgical instruments were not pre-cleaned, bioburden could have been left behind and it would be difficult to remove in the manual cleaning process. Manager #7 had stated if bioburden was left on the instruments, they could not be sterilized and could increase the risk of an SSI.

2. The facility failed to ensure expired surgical supplies were removed from the facility's inventory and not available for immediate patient use.

A. Observations

i. On 1/22/25 at 11:42 a.m., observations were conducted in OR #6. Observations revealed a supply cabinet that contained expired surgical supplies. Among the expired supplies were one Stryker Colorado microdissection needle (a needle used for cutting, dissecting, and cauterizing soft tissue) expired 1/1/25, and four Medline Skin Prep Trays with CHG ( used to prepare a patient's skin before surgery) expired between 4/30/23 through 12/31/24

ii. On 1/22/25 at 11:56 a.m., observations were conducted in OR #7. Observations revealed a supply cabinet that contained expired surgical supplies. Among the expired supplies were five 3M Steri-Drapes (a sterile drape used to create a sterile surface around the surgical site) expired between 2/11/24 through 2/5/24, and two Protexis sterile surgical gloves (a disposable sterile medical glove used during surgical procedures) expired 12/31/24.

The observations on 1/22/25 were in contrast to the Clean and Sterile Supply Storage in Clinical Areas Policy which read, supply inventory was inspected at least monthly for expiration dates. Items with expired dates were discarded or fully reprocessed if originally prepared by the hospital's sterile processing department.

B. Interviews

i. On 1/22/25 at 12:59 p.m., an interview was conducted with Tech #8. Tech #8 stated all of the OR staff were responsible for checking supply expiration dates. Tech #8 stated the OR staff would go through the supply cabinets and check for expired supplies during their downtime. Tech #8 stated expired supplies and packaging could deteriorate over time and would then not function properly. Tech #8 stated expired supplies should not have been used because they may not have worked beyond the expiration date and put the patient at risk for an SSI.

ii. On 1/22/25 at 7:13 p.m., an interview was conducted with OR Manager #7. Manager #7 stated the OR staff were responsible for checking expiration dates on their downtime. Manager #7 stated when medical supplies expired, their sterility and integrity became uncertain. Manager #7 stated it was important to check for expiration dates of medications and supplies due to the breakdown of the products and the potential patient safety concerns.