567.1 Principle
The ASF shall have a sanitary environment, properly constructed,
equipped and maintained to protect surgical patients and ASF personnel from
cross-infection and to protect the health and safety of patients.
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Observations:
Based on review of facility policy, observations, and interview with staff (EMP), it was determined that the facility failed to follow their policy and procedures for hand hygiene and exposure control program.
Findings include:
Review of facility "Infection Control Plan" approved June 27, 2023, revealed "I. Purpose: The purpose of the Infection Prevention and Control (IP&C) Plan of the Jefferson Surgical Center (referred to as JSC) is to identify and reduce the risks for acquisition and transmission of infectious agents among patients, staff, providers, contractors, students, visitors, and volunteers. ... 1. Hand hygiene a) The JSC follows the Center for Disease Control ' s (CDC) Hand Hygiene Guideline which references the World Health Organization (WHO) " Five Moments of Hand Hygiene " b) Hand hygiene opportunities: i. Before touching a patient: i. At the beginning of work ii. Upon entry into the patient care areas iii. Upon entry to the patient ' s room iv. Before patient contact, including dry skin contact v. Before contact with a wound vi. Before donning gloves when providing direct patient care (wearing gloves does not substitute for hand hygiene) ii. Before clean/aseptic procedure: i. Before handling sterile or clean supplies including medications ii. When inserting indwelling urinary catheters or other invasive devices that do not require a surgical procedure. iii.After body fluid exposure: i.After contact with wounds ii. When moving from a contaminated body site to a clean body site during patient care iii. Between completing a "dirty" task and starting a clean task (e.g. emptying the urine Foley bag and doing a BP check) iv. After removing a dirty dressing and before applying a new dressing v. After contact with patient's body substances vi. After handling equipment, supplies, or linen contaminated with body substances vii. After removing other personal protective equipment including gloves iv.After touching a patient: i. After removing gloves ii. Upon exiting the patient room v. After touching a patient's surroundings: i. After touching any part of the patient care environment (bed rail, overhead table, blood pressure cuff) ii. Exiting the patient room iii. Before leaving the unit vi. Additional hand hygiene indicators: i. Before preparing food ii. After using the restroom iii. After touching your face, nose or hair or personal device (e.g. pager, phone) iv. Additional hand hygiene may be required if hands become contaminated with blood or body fluids, or when caring for a patient on Enteric Isolation."
Observation in operating room (OR) one (1) on May 13, 2025, EMP2 was using personal device in sterile field, after using personal device did not perform hand hygiene prior to touching patient. EMP2 left sterile field to chart on wall mounted computer and computer at desk without removing gloves or performing hand hygiene. While wearing the same gloves after charting outside the sterile field EMP2 reentered the sterile field touch sterile equipment, performed two procedures on the patient and did not change gloves, nor perform hand hygiene. EMP2 was observed removing gloves, did not perform hand hygiene and touched the patient before leaving OR1 to perform hand hygiene.
Observation in OR1 on May 13, 2025, EMP3 was assisting with sterile supplies removed gloves without performing hand hygiene and began charting at desk.
Interview with EMP1 on May 28, 2025, EMP1 confirmed all information submitted is complete and accurate.
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Based on review of facility documents, observation, and employee (EMP) interview it was determined the facility failed to ensure instruments/equipment are being cleaned and disinfected properly to protect the health and safety of patients according to manufacture guidelines.
Findings include:
Review of facility document "Intercept Detergent" IFU dated February 22, 2023, revealed "Directions of Use: For cleaning of fully immersible endoscopes, related accessories, surgical instruments, and other apparatus where blood, mucus, protein or other hard to remove soils are encountered, use INTERCEPT Detergent at 1/3 oz/gal of water (0.25% use concentration) with one full stroke of the hand-pump (1 oz.) to three gallons of water. For best manual results, mix INTERCEPT Detergent with cool to warm water (20(68and ensure a minimum contact time of (1) one minute. Rinse all surfaces and internal channels thoroughly with water."
Review of "Karl Storz rhino-laryngoscope Instructions for Use (IFU)" revealed "Complete cleaning of the patient-used flexible HD video rhino-laryngoscope should be started within 2 hours of the bedside pre-cleaning. ... When preparing and using the cleaning solutions, follow the manufacturer ' s instructions for proper solution concentration and temperature. ... 1. Disinfect the cleaning sink or basin according to your healthcare facility's recommended method. 2. Rinse the sink or basin thoroughly with tap water to remove all of the disinfectant chemicals. 3. Prepare the diluted mild/neutral pH enzymatic cleaning solution (e.g. Enzol) in the sink or basin. 4. Immerse the flexible HD video rhino-laryngoscope completely in the enzymatic cleaning solution."
Observation on May 13, 2025, graduated cylinder with enzymatic detergent located at each sink where instruments are cleaned.
Interview with EMP4 on May 13, 2025, EMP4 confirmed the enzymatic detergent in the graduated cylinder is used to clean the rhino-laryngoscope. EMP4 also confirmed one notch of enzymatic detergent with five gallons of water was used to clean the rhino-laryngoscope. The amount of detergent in one notch was requested, the amount was not provided.
Interview with EMP5 on May 13, 2025, EMP5 confirmed they clean rhino-laryngoscopes using the enzymatic detergent in the graduated cylinder. EMP5 denied knowing the amount of enzymatic detergent required by manufacturer guidelines to clean the rhino-laryngoscopes.
Interview with EMP1 on May 28, 2025, EMP1 confirmed all information submitted is complete and accurate.
| | Plan of Correction - To be completed: 07/28/2025
The Jefferson Surgical Center leadership team met on 5/21/25 to discuss the citation and develop the corrective action plan. OR staff meeting was held on 6/5/2025 to review proper hand hygiene protocols. All nursing staff have been signed off on this re-education. The plan will be reviewed at the Jefferson Surgical Center Quality Committee on 6/24/25. Audits will be conducted to ensure 100% compliance with weekly audits.
Education was provided to the nursing staff. This was completed on 6/5/2025 at the departmental staff meeting. All individuals have signed off on the process. Education will also be provided to the ENT residents with a sign-off.
Twenty-five observations will be conducted for 3 consecutive months by a trained observer until 100% compliance is achieved and maintained for 3 consecutive months. Audits will be completed by JSC staff and feedback will be provided in real-time to individuals who are found to be out of compliance and fail to follow proper hand hygiene procedures. Director of nursing will be responsible for this plan. Progress toward this goal will be monitored and reported to the JSC Quality Committee and then quarterly to the Jefferson Board until the goal is met.
After the initial goal is met, ten observations will be conducted quarterly for the rest of the year.
With regard to the rhino-laryngoscopes, the sterile processing leadership team met on 6/2/2025 to discuss the citation and develop the corrective action plan. SPD staff meeting was held on 6/6/2025 to review citations and discuss scheduled in-services. All staff will be signed off on this re-education. The plan will be reviewed at the Jefferson Surgical Center Quality Committee on 6/24/25. Audits will be conducted to ensure 100% compliance with weekly audits.
Education will be provided to the SPD staff related to the cleaning of rhinoscopes and the proper use of the "scope buddy". In-services with the vendors for re-education will be scheduled and completed prior to 7/28/2025. All individuals will be signed off on receiving the education and performing the process.
Ten physical observations of the SPD staff cleaning the rhinoscopes will be conducted monthly for 3 consecutive months or until 100% compliance is achieved and maintained for 3 consecutive months. Observations will be completed by SPD leadership team, and any staff found to be non-compliant with the protocols will receive immediate feedback. The Director of nursing will be responsible for this plan. Progress toward this goal will be monitored and reported to the JSC Quality Committee and then quarterly to the Jefferson Board.
After the initial audits are complete, the SPD leadership team will continue to complete audits for the rest of the year.
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