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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 facility failed to adhere to Centers for Disease Control guidelines for surveillance to identify and resolve the serious, systemic and recurring problem involving the infection surveillance process which placed 65 of 73 sampled patients at risk for undiagnosed and untreated bloodborne pathogens.

Findings:

1. The governing body failed 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 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 facility failed to adhere to Centers for Disease Control guidelines for surveillance to identify and resolve the serious, systemic and recurring problem involving the infection surveillance process which placed 65 of 73 sampled patients at risk for undiagnosed and untreated bloodborne pathogens.

Findings:

1. The governing body failed 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 hospital failed to ensure operational direction and compliance with all Conditions of Participation resulting in a condition-level deficiency (Infection Control) not being met. The facility failed to adhere to centers for disease control guidelines for surveillance of patients exposed to potentially infectious devices. By not contacting 65 of 73 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 infection related to use of contaminated rectal probes.

Findings:

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

This systemic failure had a cumulative effect which resulted and created the systemic deficit the inability 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 of potential infection in 65 of 73 (31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94 and 95) sampled patients who had procedures completed between 2016 through 2023 with inadequately disinfected rectal probes (instrument inserted into the anus, to visualize the rectum, a part of the gastrointestinal tract).

The facility failure to contact and initiate surveillance to 65 of 73 patients exposed during a procedure has the potential to result in undiagnosed and untreated infection and spread of infection, including human immunodeficiency virus (HIV).

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's 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.

During a concurrent interview and record review on 2/26/23 at 11:30 a.m., with Director of Quality and Professional Services (DQPS) the DQPS provided an untitled list of patient names. SDPM stated the seven patient names on the list indicated the patients who had been contacted by the hospital about exposure to inadequately disinfected rectal probes.

During a concurrent interview and record review on 2/29/24 at 9:10 a.m., with DQPS, a document titled, "[hospital name] Rectal Probe Patient List," was reviewed. DQPS stated the list included the names of all patients who had procedures completed with rectal probes between 2016 through 2023 at the hospital. DQPS stated there were a total of 73 patient names on the list who were exposed to inadequately disinfected rectal probes during procedures.

During an interview on 2/28/24 at 11:30 a.m., with the Medical Director (MD), the MD stated he had reviewed patients charts of patients who had procedures with rectal probes in the last year from October 2022 through October 2023. The MD stated letters were only sent to the seven (1, 2, 3, 4, 5, 6 and 7) patients exposed during the time of October 2022 through October 2023. The MD stated there was no contact or review of patients exposed to the inadequately disinfected rectal probes prior to October 2022 because he considered the risk of infection to be very low. MD stated the hospital became aware of the lack of adequate rectal probe disinfection in November 2023 but delayed contacting the patients (1, 2, 3, 4, 5, 6 and 7) exposed in the last year until January 2024.

During a review of the documents titled, "[hospital name] Rectal Probe Patient List," and the untitled document with a list of seven patients notified of inadequately disinfected rectal probes, the review indicated 65 patients were not contacted about their exposure to inadequately disinfected rectal probes.

During a review of the rectal probe manufacturer instructions titled, "[manufacturer name] Medical User Guide Care and Cleaning," dated 6/2023, the manufacturer instructions indicated if the "device contacts mucous membranes (lining of a body cavity including the gastrointestinal tract)" or "enters otherwise sterile tissue," the probes required reprocessing including "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."