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Based on interview and record review, the governing body failed to ensure operational direction and compliance with all Conditions of Participation resulting in one condition-level deficiency (Infection Control) not being met. The governing body failed to identify and resolve the serious, systemic and recurring problem involving the infection surveillance (the ongoing, systematic collection, analysis, and interpretation of health-related data) process which placed 33 of 40 sampled patients at risk for undiagnosed and untreated bloodborne pathogens.

Findings:

1. Failure to ensure infection surveillance included all patients affected by inadequately disinfected rectal probes (instrument inserted into the anus, to visualize the rectum, a part of the gastrointestinal tract). (Refer to A-0770)
These failures had a cumulative effect and created these systemic deficits which resulted in the hospital's inability to ensure patient safety and quality healthcare.

Based on interview and record review, the facility failed to ensure operational direction and compliance with all Conditions of Participation resulting in one condition-level deficiency (Infection control) not being met. The facility failed to adhere to Centers for Disease Control guidelines for surveillance (the ongoing, systematic collection, analysis, and interpretation of health-related data) of patients exposed to potentially infectious devices. By not contacting 33 of 40 sampled patients exposed to inadequately disinfected rectal probes (instrument inserted into the anus, to visualize the rectum, a part of the gastrointestinal tract), the facility was unable to provide surveillance for signs and symptoms of infections related to use of inadequately disinfected rectal probes.

Findings:

1. The governing body failed to ensure infection surveillance included all patients affected by inadequately disinfected rectal probes. (Refer to A-0770)

These failures had a cumulative effect and created these systemic deficits which resulted in the hospital's inability to ensure patient safety and quality healthcare.

Based on interview and record review, the governing body failed to ensure a process was in place for surveillance (the ongoing, systematic collection, analysis, and interpretation of health-related data ) of potential infection all patients had procedures completed between 2019 and 2023 with inadequately disinfected rectal probes (instrument inserted into the anus, to visualize the rectum, a part of the gastrointestinal tract) used in a SpaceOAR procedure (a procedure in which a rectal probe is used to ensure proper placement of anti-cancer radioactive material in the prostate, an organ adjacent to the rectum).

The facility failure to contact and initiate surveillance of 33 of the 40 patients (Patients 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 13, 14, 15, 16, 17, 18, 19, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, and 40) who were exposed to rectal probes not disinfected per manufacturers' recommendations and national standards has the potential to result in undiagnosed and untreated infection and spread of infection, including human immunodeficiency virus (HIV, disease which impairs the body's ability to fight infection), Hepatitis B and Hepatitis C (disease of the liver potentially causing death).

Findings:

During a review of a letter dated 1/8/24, written by the Director of Accreditation, Regulation and Licensing (Dir ARL), the letter indicated the facility had knowledge of inadequate disinfection of rectal probes. The letter indicated between multiple patient procedures, the used rectal probes had not received the required high-level disinfection (complete elimination of all microorganisms in or on an instrument, except for small numbers of bacterial spores) after each procedure. The letter indicated specific patients were identified for notification and free testing for HIV, Hepatitis B and Hepatitis C.

During an interview on 2/26/24, at 2:36 p.m., with infection preventionist (IP), radiation oncology nurse manager (RNM) and Director of Radiation Oncology (DRO), IP stated on 10/20/23, a nurse raised a concern about whether rectal probes received high-level-disinfection. RNM stated she had confirmed with the contracted rectal probe provider that low-level disinfection was the standard practice for disinfecting the rectal probes and the probes had not undergone high-level disinfection between different patients. IP stated on 10/31/23, IP had contacted the health system infection control team and the facility halted the SpaceOAR procedures on 11/1/23.

During a record review of the facility's list of patients who had the SpaceOAR procedure, undated, the list indicated a total of 40 patients had the SpaceOAR procedure from 8/28/2019 to 9/25/2023.

During a record review and interview, on 2/26/24, at 1:25 p.m., with Dir ARL, a list of seven patients (Patients 11, 20, 21, 22, 23, 24 and 25) who were notified of the lack of high-level disinfection of rectal probes used in their procedure was reviewed. The list indicated the seven patients had the SpaceOAR procedure done between 11/2022 to 9/2023. Dir ARL stated the notifications were sent out on 1/10/24.

During a record review of the untitled list of the 40 total patients who had the SpaceOAR procedure and the untitled document list of seven patients notified of the inadequate disinfection of the rectal probe, a comparison of the two lists indicated 33 patients were not contacted regarding the inadequate disinfection of the rectal probes used in their SpaceOAR procedure.

During an interview on 2/28/24, at 1:00 p.m., with Medical Director of Infection Control Policy (MD 2), MD 2 stated only patients who had the procedure between 11/2022 to 11/2023 received notification of the lack of high-level disinfection of rectal probes used in their procedure. MD 2 stated he had limited the number of chart reviews for infection surveillance to patients who had the procedure in the prior two years. MD 2 stated he made a decision to delay contact of the selected seven at-risk patients until January 2024 to avoid "ruining" the patient's holiday.

During a review of the rectal probe manufacturer instructions titled, "[rectal probe manufacturer] User Guide Care and Cleaning," dated 6/2023, the manufacturer instructions indicated when the "device contacts mucous membranes (lining of a body cavity including the gastrointestinal tract)," the probes required "high-level disinfection or sterilization."

During a review of the Centers for Disease Control (CDC) article titled, "Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008," dated May 2019, the guidelines indicated, a category IB (Strongly recommended for implementation and supported by certain experimental, clinical, or epidemiologic studies and a strong theoretical rationale) recommendation as follows, "Disinfection Strategies for Other Semicritical Devices ...a. Even if probe covers have been used, clean and high-level disinfect other semicritical devices such as rectal probes, vaginal probes, and cryosurgical probes ...Use a high-level disinfectant at the FDA-cleared exposure time ...b ...Do not use a lower category of disinfection or cease to follow the appropriate disinfectant recommendations when using probe covers because these sheaths and condoms can fail."

During a review of the CDC article, "Terms, Definitions, and Calculations Used in CDC HIV Surveillance Publications," dated 3/16/22, the article indicated, "HIV infection is classified as stage 3 (AIDS) when the immune system of a person infected with HIV becomes severely compromised ... and?or the person becomes ill with an opportunistic infection. In the absence of treatment, AIDS usually develops 8 to 10 years after initial HIV infection; with early HIV diagnosis and treatment, this may be delayed by many years."

During a review of the CDC article titled, "Healthcare Investigation Guide," dated 8/10/23, the guide indicated, "Responding to information identified during assessment of health care encounters. Site visit identifies major breaches in infection prevention and control that are high-risk for bloodborne pathogen transmission ... 2. A patient notification recommending bloodborne pathogen testing should be conducted for all potentially exposed patients, even if additional cases and/or a source-patient are not identified. The scope of the patient notification will depend largely on how long the unsafe practice had been occurring in the facility."