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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 §485.640 Infection Prevention and Control and Antibiotic Stewardship Program, was out of compliance.

C-1206: 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 reviews, the facility failed to ensure methods to prevent and control the transmission of infections adhered to nationally accepted standards and guidelines in two of two observations of instrument reprocessing.


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Based on observations, interviews, and document review, the facility failed to ensure medications in the post-anesthesia care unit (PACU) were securely stored to prevent unauthorized access.

Findings include:

Facility policy:

The Medication Storage Areas policy read, drugs shall be stored in the appropriate drug storage and shall be secured with a security lock, accessible to designated staff only.

1. The facility failed to ensure medications in the expired meds bin were securely stored to prevent unauthorized access.

A. Observation

i. On 8/4/25 at 11:55 a.m., observations in the PACU revealed an open plastic bin labeled "expired meds" was sitting on top of a refrigerator next to a curtained patient care area. The bin contained two medications, Nitroglycerin (a medication used to treat chest pain by relaxing blood vessels and lowering blood pressure) and Pantoprazole (a medication used to treat conditions in which there is too much acid in the stomach). The medications were accessible to anyone who entered the PACU.

This observation was in contrast to the Medication Storage Areas policy which read, drugs should have been stored in the appropriate drug storage and should have been secured with a security lock, accessible to designated staff only.

B. Interview

i. An interview was conducted on 8/4/25 at 12:05 p.m. with the surgical director (Director) #2. Director #2 stated medications in the PACU should have been secured to prevent unauthorized access. Director #2 stated the Nitroglycerin and Pantoprazole were placed in the plastic bin four days ago. Director #2 stated it was important for medications to be kept behind a locked door, especially in an area accessible to patients and visitors. Director #2 stated there was a safety risk if someone accessed medications that were not secured. Director #2 stated each type of medication had different risks, side effects, and a potential for an allergic reaction. Additionally, Director #2 stated there was a risk of dangerously low blood pressure if someone took a medication that lowered blood pressure.

Based on observations, interviews, and document reviews, the facility failed to ensure methods to prevent and control the transmission of infections adhered to nationally accepted standards and guidelines in two of two observations of instrument reprocessing.

Findings include:

Facility policy:

The Sterile Processing Department (SPD) Infection Control policy read, trained personnel will be able to demonstrate or verbally explain procedures used for cleaning prior to sterilization according to site-specific policy and or manufacturer/product label directions.

References:

The Integra Miltex manufacturer's instructions for use (IFU) read, proper cleaning is essential, an instrument may not be successfully sterilized if it is not completely clean. To ensure effective cleaning, dissimilar metals should be separated, and instruments should be inspected for functionality. Accepted cleaning methods include ultrasonic cleaning (most effective), manual cleaning, and the use of automatic washers. The autoclaving section read, sterilize instruments individually or in sets. Additionally, unlock all hinged instruments and sterilize in an open position. Use a wide enough pouch (peel pack) for instruments with ratchet locks and hinges so the instrument can be sterilized in an open (unlocked) position. Instruments that are locked and closed during autoclaving can develop cracked hinges (box locks) or other problems because of heat expansion. Unlock all instruments and sterilize in an open position.

The Rapicide OPA/28 manufacturer's IFU read, Rapicide is a high-level disinfectant solution for reprocessing of heat sensitive semi-critical medical devices for which sterilization is not suitable. Devices to be reprocessed must first be thoroughly cleaned according to the device manufacturer's recommendations for decontamination. The Cleaning/Decontamination section read, Rapicide OPA/28 should not be used to high-level disinfect when sterilization is available and practical.

The Association of periOperative Registered Nurses (AORN), 2025, Guidelines for Perioperative Practice, Guideline for Instrument Cleaning read, clean and decontaminate surgical instruments according to the manufacturer's validated, written IFU. Provide the manufacturer's IFU to personnel responsible for processing instruments and reusable medical devices. IFUs identify the processes necessary to achieve effective decontamination and sterility. Establish a process for regular review of the instrument manufacturers' IFU to verify facility reprocessing practices comply with the most current manufacturer's IFU. The instrument manufacturers have determined the steps and processes necessary to clean a device effectively. Unless contraindicated in the manufacturer's IFU, submerge the device in a cleaning solution that is compatible with the device.

The American National Standards Institute/The Association for the Advancement of Medical Instrumentation (ANSI/AAMI) ST79, 2022, read, instrument packaging is intended to maintain the sterility of the instrument and protect the instrument until use. A barrier system (peel pouches) provides a sterile barrier to protect from microorganisms during handling, distribution, transport, and storage. Any instrument in damaged packaging should not be used.

1. The facility failed to ensure surgical instruments were cleaned and sterilized as required by the manufacturer's IFU, national guidelines, and facility policy.

A. Observations

i. On 8/4/25 at 11:50 a.m., observations were conducted in the medical clinic. Observations revealed surgical instruments were cleaned with Rapicide. This contrasted with the Rapicide manufacturers IFU which stated, Rapicide was a high-level disinfectant and should not be used to sterilize reusable surgical instruments. The observation also contrasted with the Integra Miltex surgical instrument manufacturer's IFU which stated, high-level chemical disinfection solution was not an approved cleaning method for the surgical instruments.

Medical assistant (MA) #1 was observed transporting surgical instruments used for podiatry procedures to the instrument reprocessing area in a hard blue plastic container. The container held four nail nippers (used to cut thick or tough toenails), three scalpel handles with surgical blades attached, and two nail curettes (used to scrape under and around toenails). MA #1 removed one nail nipper, brushed it under running water, soaked it in Rapicide for 15 minutes, and then rinsed it under running water for one minute.

MA #1 placed the nail nipper on a paper towel on the countertop and dried it with a separate paper towel. The instrument was then placed back into the hard blue plastic container, which had not been cleaned. Additionally, the blue container also held other contaminated surgical instruments. At the time of observation, the instrument was not sterile because it had not been autoclaved (sterilized) in an unlocked, open position according to the manufacturer's IFU, and had also not been enclosed in intact sterile packaging.

This observation contrasted with the Integra Miltex manufacturer's IFU and ANSI/AAMI ST79 guidelines. The Integra Miltex manufacturer's IFU stated, sterilize individual instruments in an unlocked, open position in a disposable paper or plastic pouch. Additionally, according to ANSI/AAMI ST79 guidelines, sterile packaging must be used to protect surgical instruments from contamination during storage, transportation and handling. Missing or compromised packaging renders the surgical instrument non-sterile.

ii. On 8/4/25 at 12:17 p.m., observations were conducted of the peel-packed surgical instruments stored in the clinic. Observations revealed several hinged instruments had been sterilized in the closed or locked position. The instruments observed included eight hemostats (used to clamp blood vessels or hold tissue), four Lahey forceps (with small interlocking teeth for grasping tissue), three Babcock forceps (used to hold soft tissue), and three dissecting scissors (used for cutting tissue).

This observation contrasted with the Integra Miltex surgical instrument manufacturer's IFU which stated, instruments were to be sterilized in the unlocked and open position.

Further observations of peel-packed instruments in the clinic revealed eight pairs of single-use disposable Littauer scissors (small surgical scissors) and straight tip forceps (surgical instrument used to grasp and hold), which had been reprocessed and sterilized.

During the observation, instrument manufacturer's IFUs were not observed to be present or readily available and accessible to clinic staff.

Upon request, the facility was unable to provide the manufacturer's IFU for the Littauer scissors and straight tip forceps, or any evidence both instruments could be reprocessed and reused.

This was in contrast to AORN Guideline for Instrument Cleaning, which stated, the manufacturers' IFUs should be readily accessible to staff who clean surgical instruments and reviewed regularly to ensure proper cleaning of the instruments.

iii. On 8/6/25 at 9:55 a.m., an observation was conducted in the sterile processing department (SPD). During the observation, surgical technician (Tech) #4 reprocessed surgical instruments from a dilation and curettage set (D&C set).

After the observation, the recipe list (a list of every instrument in the set) and manufacturers IFUs for the instruments in the D&C set were requested. In response to the request, surgical director (Director) #2 stated they were unable to provide the manufacturer's IFU for four of the surgical instruments in the D&C set.

The instruments without a manufacturer's IFU included an Adair Allis forceps (multi-toothed forceps used to grasp tissue), an Amico Allis forceps, a pair of Metzenbaum scissors (scissors used to cut delicate tissue), and a uterine probe (instrument used to measure the depth and direction of the uterus).

This observation contrasted with the facility's SPD Infection Control policy, which stated staff were to clean instruments in accordance with the manufacturer's IFU.

The observation also contrasted with the AORN Guideline for Instrument Cleaning, which stated surgical instrument manufacturers have determined the necessary steps required to decontaminate and sterilize surgical instruments, and these IFUs should be present and accessible to staff who reprocess the instruments.

B. Interviews

i. On 8/4/25 at 12:50 p.m., an interview was conducted with MA #1. MA #1 stated they did not know surgical instruments used for podiatry procedures needed to be reprocessed and sterilized. MA #1 stated they had been told the instruments used for podiatry procedures should be cleaned with Rapicide. MA #1 further stated they were unfamiliar with what a manufacturer's IFU was, its purpose, how to access it, or why it was necessary.

This contrasted with the AORN Guideline for Instrument Cleaning, which stated, surgical instruments should be cleaned according to the manufacturer's IFU and, the manufacturer's IFU should be given to and reviewed with staff who clean the instruments.

ii. On 8/4/25 at 12:15 p.m. and on 8/6/25 at 2:41 p.m., interviews were conducted with surgical director (Director) #2. Director #2 stated surgical instruments should be reprocessed in accordance with the manufacturer's IFU. Director #2 stated manufacturer IFUs were available in both paper and online formats, and SPD staff were able to easily access them when needed. Director #2 stated following the manufacturer's IFUs was essential for patient safety since it ensured instruments were properly cleaned and prevented the transmission of infections.

However, during the survey, the facility was unable to provide the manufacturer's IFUs for four instruments in the D&C set when requested, which directly contrasted with Director #2's earlier statement about their availability and ease of access.

Additionally, Director #2 acknowledged the facility could not locate the manufacturer's IFUs for the four instruments in the D&C set. Director #2 stated SPD staff relied on the manufacturer's IFUs to determine the steps needed to properly reprocess surgical instruments. Director #2 further stated without the IFUs, it was not possible to properly clean those four instruments, and the instruments had to be pulled from the set entirely. Lastly, Director #2 stated that not having the manufacturer's IFUs readily available for the surgical instruments posed significant patient safety risks.


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