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Based on observation, interview, and record review, the facility failed to meet the Conditions of Participation for Infection Control as evidenced by,

The facility failed to properly sanitize, clean, and store the facility's endoscopy scopes, and transvaginal ultrasound probe, placing patients at risk of infections from cross-contamination.
Refer to: C1231

The facility failed to properly maintain, adequate sanitizing supplies, and ensure effective surveillance of its Infection Control practices, placing patients at risk of infections from cross-contamination.
Refer to: C1208

Based on observation, interview, and record review, the facility failed to provide a clean and sanitary environment to avoid sources and transmission of infection when the facility failed to:

a.) properly sanitize and ensure a tracking system was in place for the facility's:
(1) transvaginal ultrasound probe, and
(2) endoscopy scopes.
These practices placed patients at risk of infection and prevented the facility from being able to contact patients if there was an exposure.

b.) properly maintain adequate sanitizing supplies and ensure effective surveillance of its Infection Control practices, placing patients at risk of infections.

Finding include:

a.) (1) During an interview, on the afternoon of 5/17/22, while touring the facility's Radiology department, when asked how the facility sanitizes the transvaginal ultrasound probe, Staff #5, Radiology Technician stated, "We wipe it in-between patients with the Protex, it is approved by the manufacturer."

During an interview, on the afternoon of 5/17/22, while touring the facility's Radiology department, Staff #11, CNO [Chief Nursing Officer] confirmed the finding and reported they hadn't been aware that the probe needed to be High-level disinfected.

During an interview, on the afternoon of 5/18/22, in the facility's conference room, when asked if the facility had a log for the tracing of the facility's vaginal probe's use, Staff#11, CNO, stated, "No."

Review on 5/21/22 of the American Institute of Ultrasound in Medicine website, found at: https://www.aium.org/officialstatements/57 (reviewed 3/5/21) reflected, "Guidelines for Cleaning and Preparing External- and Internal-Use Ultrasound Transducers and Equipment Between Patients ... Preparation of internal transducers between patients requires routine mandatory high-level disinfection (HLD) and the use of a high-quality single-use transducer cover during each examination."

Review of the Protex disinfectant spray's manufacturer label reflected, "This product is not to be used as a terminal sterilant/high level disinfectant on any surface or instrument that (1) is introduced directly into the human body, either into or in contact with the bloodstream or normally sterile areas of the body, or (2) contacts intact mucous membranes but which does not ordinarily penetrate the blood barrier or otherwise enter normally sterile areas of the body."

a.) (2) Observations made on the morning of 5/18/22, of the facility's endoscopy cleaning room, revealed a Medivator Reprocessor Model MV-1. The facility uses the machine to reprocess (clean) upper gastrointestinal and colonoscopy scopes. The lid of the washer was closed, the interior was noted to have water droplets hanging from the inside of the lid. When the lid was opened, the interior chamber was noted to be wet with copious amounts of brown, slimy substances on the inside base chamber, there was a 1 1/2-inch strand of algae like growth hanging where the sanitizer and rinse liquids are dispensed into the cleaning chamber.

During an interview, on the morning of 5/18/22, in the facility's endoscopy cleaning room, Staff #14, Sterile Processing RN [Registered Nurse] stated, "I ran it last night ...We keep the lid closed ...We only do procedures once a week." When asked how they were trained, Staff #14 stated, "I was trained by the last SPD [Sterile Processing Department] person ...We've had the new washer since August (2021), I've seen water in there, but not the yellow-brown." When asked if the lid was supposed to be kept open or shut after use, Staff #14 was unable to answer.

During an interview, on the afternoon of 5/18/22, in the facility's conference room, Staff#11, CNO, stated, "I spoke to the Medivator representative and sent him pictures, he said we should open the lid after use." Staff #11 confirmed the Manufacturer's Manual did not include the requirement to open the lid after use.

During an interview, on the morning of 5/18/22, in the facility's endoscopy cleaning room, when asked if the facility had a log for the tracing of the facility's endoscopy scopes' use Staff #14, Sterile Processing RN stated, "We don't keep a log."

Review of the CDC [Centers for Disease Control and Prevention] website on 5/20/22, found at: https://www.cdc.gov/hicpac/recommendations/flexible-endoscope-reprocessing.html reflected the following:
"Leadership of the healthcare organization or practice setting where flexible endoscopes are used and/or reprocessed is accountable for:
a. Allocating sufficient human and material resources to ensure that the selection, use, and reprocessing of endoscopes and related accessories are managed in a manner that minimizes infection risk and supports patient and healthcare worker safety.
b. Supporting and empowering the authority of those responsible for managing infection prevention practices to ensure effectiveness of the program.
c. Ensuring that the essential elements of an endoscope reprocessing program are followed and that endoscopes are reprocessed according to manufacturers' IFU [Instructions For Use] ...
Ensure that each endoscope has a unique identifier to facilitate tracking. Tracking should include the ability to determine when specific endoscopes were used for specific patients, loaned to other units or facilities, reprocessed, or repaired. Tracking is also essential for responding to device or product recalls ..."

b.) Observations made, on the afternoon of 5/17/22, accompanied by Staff #11, CNO, revealed a sign on the facility's biohazard room informing staff to, "Wash hands before leaving this area."
The hand sink, located inside the room, did not have hand soap, preventing the staff from sanitizing their hands after handling soiled items. The nearest alcohol hand sanitizer dispenser was located across a wide hallway; the alcohol would not be adequate to clean heavily soiled hands.

Observations made of the facility's laundry department, on the afternoon of 5/17/22, revealed an alcohol hand sanitizer dispenser placed at the entrance/exit of the laundry room; the dispenser was not functioning. Inside the soiled laundry area, there was only one hand sink which was being blocked by cleaning carts.

Observations of the facility's Emergency department, on the afternoon of 5/17/22, revealed:
*Four patient treatment rooms had hand sink cabinets with dark brown stains, debris, and peeled paint. There were patient supplies stored under the four sinks, which could be exposed to water or moisture.
*The high-acuity room had a box of sterile procedure gloves stored under the hand sink and available for use, which could be exposed to water or moisture. The following was available for use under a dirty cabinet: opened & previously sterile supplies, an opened filtered needle, and an opened surgical device.

Observation of the facility's Laboratory department, on the afternoon of 5/17/22, revealed a hand sink's cabinet with rusting metal debris and chipped paint on the cabinet base.

During the tour on the afternoon of 5/17/22, Staff #11, CNO, confirmed the empty soap dispensers and dirty sink cabinet findings and stated, "There shouldn't be anything under the sinks."

Review of the CDC website on 5/21/22, found at: https://www.cdc.gov/handhygiene/providers/guideline.html reflected the following:
"Healthcare personnel should use an alcohol-based hand rub or wash with soap and water for the following clinical indications:
Immediately before touching a patient
Before performing an aseptic task (e.g., placing an indwelling device) or handling invasive medical devices
Before moving from work on a soiled body site to a clean body site on the same patient
After touching a patient or the patient's immediate environment
After contact with blood, body fluids, or contaminated surfaces
Immediately after glove removal
Healthcare facilities should:
Require healthcare personnel to perform hand hygiene in accordance with Centers for Disease Control and Prevention (CDC) recommendations
Ensure that healthcare personnel perform hand hygiene with soap and water when hands are visibly soiled
Ensure that supplies necessary for adherence to hand hygiene are readily accessible in all areas where patient care is being delivered."

Review of the facility provided Infection Control policy titled "Pest Control" (undated) reflected,
"1. Crane Memorial Hospital intends to maintain an environment that is clean,
sanitary, and attractive for patients, visitors, and staff. This is accomplished by:
a. Daily cleaning of the hospital using infection control standards for cleaning.
b. Observing and responding to issues identified through routine rounding on the hospital.
...All employees of the hospital are responsible for reporting issues they identified through observations throughout the hospital."

Review of the facility provided Infection Control job description reflected,
"21. Monitors proper use of germicides, cleaning products, antiseptics, and disinfectants in use throughout the facility.
22. Monitors methods of asepsis, sterilization and disinfection employed throughout the facility.
23. Reviews and/or revises all department policies and procedures related to infection control on a concurrent basis..."

Based on interview and record review, the facility failed to develop and implement infection control surveillance, prevention, and control policies and procedures that adhere to nationally recognized programs to prevent infections through cross contamination when:
- the facility's Infection Control Program did not include the Surveillance of all patient care areas
- the Surgical and Radiology department's equipment cleaning procedures did not follow nationally recognized sanitation standards.


Finding include:

During an interview, on the afternoon of 5/17/2022, Staff #6, Infection Control Nurse stated, "I monitor different things at different times." When asked if they monitor the sanitation procedures for the facility's Trans-vaginal probe as part of their infection control program, Staff #6 stated, "I don't monitor any hospital equipment." Staff #6 confirmed they did not monitor the infection control practices for the Radiology or Surgery Departments.

Staff #6 was not aware the transvaginal probe was not being high-level disinfected, the Endoscope washer had contaminates in the wash basin, and the hand-sink cabinets were dirty.

Review of the American Institute of Ultrasound in Medicine website on 5/21/22, found at: https://www.aium.org/officialstatements/57 (reviewed 3/5/21) reflected, "Guidelines for Cleaning and Preparing External- and Internal-Use Ultrasound Transducers and Equipment Between Patients ... Preparation of internal transducers between patients requires routine mandatory high-level disinfection (HLD) and the use of a high-quality single-use transducer cover during each examination."

Review of the Protex disinfectant spray's manufacturer label reflected, "This product is not to be used as a terminal sterilant/high level disinfectant on any surface or instrument that (1) is introduced directly into the human body, either into or in contact with the bloodstream or normally sterile areas of the body, or (2) contacts intact mucous membranes but which does not ordinarily penetrate the blood barrier or otherwise enter normally sterile areas of the body."


Review of the facility provided Infection Control job description reflected,
"21. Monitors proper use of germicides, cleaning products, antiseptics, and disinfectants in use throughout the facility.
22. Monitors methods of asepsis, sterilization and disinfection employed throughout the facility.
23. Reviews and/or revises all department policies and procedures related to infection control on a concurrent basis ..."

Review of the CDC website on 5/21/22, found at: https://www.cdc.gov/handhygiene/providers/guideline.html reflected the following:
"Healthcare personnel should use an alcohol-based hand rub or wash with soap and water for the following clinical indications:
Immediately before touching a patient
Before performing an aseptic task (e.g., placing an indwelling device) or handling invasive medical devices
Before moving from work on a soiled body site to a clean body site on the same patient
After touching a patient or the patient's immediate environment
After contact with blood, body fluids, or contaminated surfaces
Immediately after glove removal
Healthcare facilities should:
Require healthcare personnel to perform hand hygiene in accordance with Centers for Disease Control and Prevention (CDC) recommendations
Ensure that healthcare personnel perform hand hygiene with soap and water when hands are visibly soiled
Ensure that supplies necessary for adherence to hand hygiene are readily accessible in all areas where patient care is being delivered."