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Based on observations, interviews, and document reviews, the hospital failed to ensure they had an effective, active system wide infection control program for the prevention, control, and investigation of infections and communicable diseases. The infection control program did not meet the needs of all patients receiving care and supportive healthcare in the hospital, as evidenced by:

1. Clean GI (gastrointestinal, pertaining to the esophagus, stomach, and intestines) scopes (flexible, lighted tube with a camera to visually examine the esophagus, stomach, and first part of the intestines) were stored in a procedure room and not compliant with National Infection Control Standards the hospital followed (refer to A-0749 finding 1);

2. There was no documented evidence to demonstrate the storage cabinet used to store flexible scopes was cleaned and maintained according to the manufacture instructions for use (IFUs) (refer to A-0749 finding 2);

3. The hospital SPD decontamination room (a room used to clean and disinfect re-usable patient surgical instruments) did not consistently maintain negative pressure (the air pressure inside the room is lower than the air pressure outside the room which means that when the door is opened, potentially contaminated air or other dangerous particles from inside the room cannot flow outside into non-contaminated areas). The doors were opened frequently, which opened directly into the Operating Room (OR) corridor which faced OR 3 (a room that was in use during a patient surgical procedure). In addition, the doors had gaps beneath and between the doors and the doors did not open in a unidirectional workflow pattern (refer to A-0749 finding 3);

4. Surgical brushes used to clean soiled surgical instruments were not cleaned between use (refer to A-0749 finding 4);

5. Two of two surgical processing staff (SPD Tech 1 & 2) did not adhere to the contact time (the amount of time a disinfectant needs to remain wet on a surface to effectively kill germs and achieve the desired level of sanitation) of the Super Sani wipes (cleaning and disinfectant wipes) (refer to A-0749 finding 5);

6. Three of three SPD staff employee files did not contain documented evidence they received job specific competencies (refer to A-0749 finding 6);

7. The Infection Control Director's (ICD) employee file did not contain documented evidence to demonstrate she was appointed by the hospital's Governing Body (group of directors responsible for overseeing the hospital's operations) & that the appointment was based off of Medical & Nursing Leadership (refer to A-0748 finding 1);

8. Four (4) sterilized and ready to use surgical instruments contained the following: one (1) instrument contained black non-smooth matter, 1- contained sticky residue, and two (2) instruments contained non-manufacture etching that was course to touch (refer to A-0749 finding 7);

9. The autoclave (a machine used to sterilize surgical instruments) was not cleaned and maintained according to manufacture IFU (refer to A-0749 finding 8);

10. The hospital Sterile Processing Department Prep & Pack (an area used to prepare clean surgical instruments for sterilization and reuse) area did not receive terminal cleaning (a thorough, hospital cleaning focused on eliminating all pathogens from a room, especially in healthcare settings, after use to prevent the spread of infections) (refer to A-0749 finding 9); and

11. Cleaning and disinfection of endoscopy gastrointestinal (GI) flexible scopes (thin flexible tubes with a camera and light used to visualize the interior of the digestive tract) was not performed in a unidirectional workflow pattern and the GI processing room was not designed to contain contaminants and did not facilitate the highest level of infection control (refer to A-0749 finding 10).

The cumulative effects of these systemic problems resulted in the hospital's inability to provide an effective hospital wide Infection Control Program. Resulting in the hospitals inability to provide patient care in a safe and effective manner and in accordance with §482.42 Condition of Participation for Infection Control Services.

§482.42 Condition of Participation for Infection Prevention/Control/Antibiotics Stewardship Program, NOT MET.

The cumulative effects of these systemic problems resulted in the hospital's inability to provide an effective hospital wide infection control program, resulting in the hospitals inability to provide patient care in a safe and effective manner and in accordance with §482.42 Condition of Participation for Infection Prevention/Control/Antibiotics Stewardship Program. The seriousness of which, resulted in an Immediate Jeopardy (IJ), which was identified by the survey team.

Immediate Jeopardy

On March 4, 2025, at 10:25 a.m., the survey team identified significant concerns in the hospital's Infection Control Program, when clean GI scopes were stored in a procedure room, there was no documented evidence the scope cabinet was cleaned according to manufacture IFUs, and (&) surgical brushes used to clean soiled surgical instruments were not cleaned between use. Due to the seriousness of the situation, an Immediate Jeopardy (IJ) was declared for failing to maintain an environment to prevent the risk of cross contamination. The IJ was called in the presence of the Chief Executive Officer, Director of Risk and Quality, Infection Control Director, Chief Human Resources Officer, Chief Nurse Executive, Chief Human Resource Officer, and Vice President and Ancillary Services (Refer to A-0749 findings 1, 2, & 4).

On March 4, 2025, at 1 p.m., the hospital's Director of Risk & Quality (DRQ) provided the team an acceptable corrective action plan (CAP) to lift the immediacy of the IJ. The CAP indicated:
- Scope cabinet relocated to GI (gastrointestinal) Hallway. The new location is in designated secure, clean, positive pressure space outside of procedure rooms and OR (operating room) suites;
- Process in place for maintaining sterility of scopes being moved from cabinet to special procedure room;
- Associates responsible for cleaning the scope cabinet will receive training and have competency on file. Training will include use of required personal protective equipment (PPE, equipment which includes surgical masks, gloves, and gowns) and use of only the EPA (Environmental Protection Agency, a national agency) registered disinfectants per cabinet IFUs (instruction for use). Training will also include frequency of cleaning per cabinet IFUs, minimum of weekly and as needed. The training process will include any new hires and an annual review of process per cabinet IFUs;
- New process will include clean/sterile scopes being removed from cabinet by trained GI Tech prior to any cabinet cleaning. A gown and gloves will be worn during removal of scopes prior to cleaning process as well as during return to cabinet. Scopes will be maintained in a clean field while the cabinet is cleaned. Tech will return scopes to the cabinet after the cleaning process is complete wearing required PPE;
- All surgical brushes will be one time use; and
- In service of all Sterile Processing Department (SPD) techs will include new process and notification that this is effective immediately. This training process will include any new hires.

On March 5, 2025, at 3:44 p.m., the CAP for the immediate jeopardy was reviewed and was found acceptable.

On March 6, 2025, at 12 p.m., the immediate jeopardy was abated, after the team validated, through onsite observations, interviews, and record reviews, the hospital's corrective action plan was implemented. The IJ was removed in the presence of the DRQ and the DIP.

Based on observations, interviews, and record reviews, the hospital failed to provide surgical services in a well-organized manner and in accordance with acceptable standards of practice. This failure had the potential of transmission of infectious agents and foreign material from reusable instruments to patients and staff. The hospital failed to comply with the §482.51 Condition of Participation for Surgical Services when:

1. Surgical brushes used to clean soiled surgical instruments were not cleaned between use (refer to A-0951 finding);

2. Two of two surgical processing staff (SPD Tech 1 & 2) did not adhere to the contact time (the amount of time a disinfectant needs to remain wet on a surface to effectively kill germs and achieve the desired level of sanitation) of the Super Sani wipes (cleaning and disinfectant wipes) (refer to A-0951 finding 2);

3. Three of three SPD staff employee files did not contain documented evidence they received job specific competencies (refer to A-0951 finding 3);

4. Four sterilized and ready to use surgical instruments contained the following: one instrument contained black non-smooth matter, 1- contained sticky residue, & two instruments contained non-manufacture etching that was coarse to touch (refer to A-0951 finding 4);

5. The autoclave (a machine used to sterilize surgical instruments) was not cleaned and maintained according to manufacture IFU (refer to A-0951 finding 5);

6. The hospital Sterile Processing Department Prep & Pack (an area used to prepare clean surgical instruments for sterilization and reuse) area did not receive terminal cleaning (a thorough, hospital cleaning focused on eliminating all pathogens from a room, especially in healthcare settings, after use to prevent the spread of infections) (refer to A-0951 finding 6);

7. The hospital SPD decontamination room (a room used to clean and disinfect re-usable patient surgical instruments) did not consistently maintain negative pressure, (the air pressure inside the room is lower than the air pressure outside the room. Which means that when the door is opened, potentially contaminated air or other dangerous particles from inside the room cannot flow outside into non-contaminated areas). The doors were opened frequently, which opened directly into the Operating Room (OR) corridor which faced OR 3 (a room that was in use during a patient surgical procedure). In addition, the doors had gaps beneath and between the doors and the doors did not open in a unidirectional workflow pattern (refer to A-0951 finding 7); and

8. The Director of Surgical Services was qualified by training and experience to manage the Surgical Service Department in accordance with nationally recognized perioperative practices, guidelines, and regulations (Refer A-0942).

The cumulative effects of these systemic problems resulted in the hospital's inability to provide effective hospital wide surgical services and failed to ensure patient care requiring surgical services were provided in a safe and effective manner and in accordance with the §482.51 Condition of Participation for Surgical Services.

These deficient practices resulted in the Condition of Participation for Surgical Services being NOT MET.

Based on observation, interview, and record review, the facility failed to ensure supplies and equipment were maintained at an acceptable level of safety and quality when:

1. Disposable surgical instruments were not disposed of properly at the bedside in accordance with the facility's policy and procedure; and

2. Multiple expired supplies and equipment were readily available for use.

These failures had the potential to delay patient care and services or cause patient harm.

Findings:

1. On March 3, 2025, 10:31 a.m., an observation and concurrent interview were conducted with the ICU Registered Nurse (ICURN) 2 in the Intensive Care Unit (ICU, unit for patients who are critically ill and kept under constant observation). An uncovered small three compartment blue tray was observed on the counter in the soiled utility room. The container was observed to contain two metal tweezers, three metal clamps, and one pair of metal scissors. The container and the metal instruments were observed to have reddish brownish stains. ICURN 2 stated reusable surgical instruments were not used on patient floors. He stated he was not sure why they were there.

On March 3, 2025, at 10:35 a.m., an interview was conducted with the Graduate Medical Education Coordinator (GMEC). She stated reusable instruments are not used on patient floors. The GMEC stated all instruments used on patient floors are disposable instruments. She stated after use, the instruments should have been discarded in the sharps container (specialized, puncture resistant waste receptacle) in the patient's room. She further stated the disposable surgical instruments should not have been placed in the dirty utility room.

A review of the policy and procedure (P&P) titled, "External Departments - Instrument Transportation/Reprocessing," dated August 2021, was conducted. The document indicated, "...All single use items will be used only once and then disposed of in the correct manner...Each department/unit is responsible for sharps removal..."

2a. On March 3, 2025, 9:55 a.m., an observation and concurrent interview were conducted with the Director of Emergency Department (DED) and the Graduate Medical Education Coordinator (GMEC) in the ICU. During the observation the following expired products and supplies were observed:

- 41 grey top vacutainers, with expiry date of April 7, 2024;
- 10 red top vacutainers, with expiry date of December 11, 2023;
- One dressing change kit, with expiry date of October 26, 2024;
- One dressing change kit, with expiry date of January 1, 2025;
- One dressing change kit, with expiry date of February 22, 2025;
- Two Safe-T-Centesis (instrument used for thoracentesis [a procedure of removing fluid from area between the lungs and chest wall] and paracentesis [a procedure in which a thin needle or tube is put into the abdomen to remove fluid]) Plus 8 (eight) Fr (french, outer diameter circular devices equivalent to 2.67 centimeter [unit of measurement]) Catheter (a thin plastic tube) Drainage Tray, with expiry date of February 28, 2025;
- One Acute High Pressure Triple Lumen Catheter (a type of tubing with three separate channels, which when inserted into a vein would allow for simultaneous administration of multiple medications or fluids) Tray, with expiry date of February 28, 2025; and
- Two Radial Artery Catheterization (a thin tube inserted through a blood vessel in the arm into the heart and its blood vessels) kits, with expiry date of October 31, 2024.

A concurrent interview with the DED was conducted. She stated the materials management department stocks the supply room. She further stated the certified nursing assistants restock the small supply room from the large supply room when needed. The DED stated registered nurses were responsible for checking the expiration dates prior to patient use. The DED stated expired products should have been removed and not be available for patient use.

On March 6, 2025, at 3:06 p.m., an interview was conducted with the Director of Materials (DOM). The DOM stated materials management was in charge of stocking supplies in the ICU. The DOM stated supplies were stocked every three days. The DOM stated materials management staff would check for expired items when they stock and if the items are found expired, these will be discarded. The DOM stated the expectation would be to remove any expired items, discard them, and replace them with new ones.

2b. On March 3, 2025, 11:05 a.m., an observation was conducted with the Director of Obstetrics (DOB) in the Obstetrics unit (OB, unit which focuses on pregnancy and childbirth). During the observation, four sterile tubing kits, with expiry date of December 31, 2024, were observed. During a concurrent interview, the DOB stated expired supplies should have been removed from the supply room and replaced with unexpired supplies.

2c. On March 3, 2025, at 11:08 a.m., an observation was conducted with the Director of Risk and Quality (DRQ) in the Pre-Operative Unit (unit where patients are prepared for surgery). During the observation the following expired products and supplies were observed:

- Two intravenous (IV, inserted through a vein) start kits, with expiry date of January 28,2025;
- One IV start kit, with expiry date of August 22, 2024; and
- One IV start kit, with expiry date of September 9, 2024.

During a concurrent interview, the DRQ stated registered nurses were responsible for checking expiration dates prior to patient use. The DRQ stated expired products should have been removed and not be readily available for patient use.

2d. On March 3, 2025, at 2:48 p.m., an observation was conducted with the DRQ in Operating Room 3. During the observation, a bougie (a thin, flexible surgical instrument) was on top of an anesthesia cart and was observed labeled with an expiry date January 1, 2024. The DRQ stated anesthesia technicians were responsible for checking expiration dates prior to patient use. The DRQ stated expired products should have been removed and not be available for patient use.

A review of the policy and procedure titled, "Sterile Processing - Event Related Sterility/Shelf Life," dated August 202,4 was conducted. The policy indicated, "...All items are marked with the date of sterilization...Any item that has a manufacturer indicated expiration date will not be used past the indicated expiration date...Staff will be assigned on a monthly basis to search for and remove any items (commercially or internally processed) displaying an expired or soon to expire (within the month) date...Commercially expired items will be sent back to Material Management for disposal/return..."

Based on interview and record review, the hospital failed to ensure the Director of Infection Prevention (DIP) was appointed by the governing body as the Infection Preventionist when the Infection Control Director's (ICD) employee file did not contain documented evidence to demonstrate she was appointed by the hospital's Governing Body (GB - group of directors responsible for overseeing the hospital's operations) and that the appointment was based off of Medical & Nursing Leadership.

This failure ahs the potential for infection preventio and control practices to not be implemented appropriately.

Finding:

1. On March 4, 2025, at 11:50 a.m., the employee file of the DIP was reviewed with the Human Resources Generalist (HRG), the employee file did not have documented evidence to indicate DIP was appointed by the hospital's Governing Body.

On March 4, 2025, at 3:40 p.m., during an interview with the DIP, she validated the above findings and stated that she was hired by the Chief Nurse Executive (CNE) and was not appointed by the GB. In addition, she stated she was not aware that the regulation required her to be appointed by the GB.

Based on observation, interview, and record review, the hospital failed to ensure a system was in place for identifying, reporting, investigating, and controlling infections and communicable diseases when:

1. Clean GI (gastrointestinal, pertaining to the esophagus, stomach, and intestines) scopes (flexible, lighted tube with a camera and light used to visualize the interior of the digestive tract) were stored in a procedure room and not compliance with National Infection Control Standards the hospital followed (refer to A-0749 finding 1);

2. There was no documented evidence to demonstrate the storage cabinet used to store flexible scopes was cleaned and maintained according to the manufacture instructions for use (IFUs) (refer to A-0749 finding 2);

3. The hospital Sterile Processing Department (SPD) decontamination room (a room used to clean and disinfect re-usable patient surgical instruments) did not consistently maintain negative pressure (the air pressure inside the room is lower than the air pressure outside the room which means that when the door is opened, potentially contaminated air or other dangerous particles from inside the room cannot flow outside into non-contaminated areas). The doors were opened frequently, which then opened directly into the Operating Room (OR) corridor which faced OR 3 (a room that was in use during a patient surgical procedure). In addition, the doors had gaps beneath and between the doors and the doors did not open in a unidirectional workflow pattern (refer to A-0749 finding 3);

4. Surgical brushes used to clean soiled surgical instruments were not cleaned between use (refer to A-0749 finding 4);

5. Two of two surgical processing staff (SPD Techs 1 and 2) did not adhere to the contact time (the amount of time a disinfectant requires to remain wet on a surface to effectively kill germs and achieve the desired level of sanitation) of the Super Sani wipes (cleaning and disinfectant wipes) (refer to A-0749 finding 5);

6. Three of three SPD staff employee files did not contain documented evidence they received job specific competencies (refer to A-0749 finding 6);

7. Four sterilized and ready to use surgical instruments contained the following: one instrument contained black non-smooth matter, 1 instrument contained sticky residue, & two instruments contained non-manufacture etching that was coarse to touch (refer to A-0749 finding 7);

8. The autoclave (a machine used to sterilize surgical instruments) was not cleaned and maintained according to manufacture IFU (refer to A-0749 finding 8);

9. The hospital SPD Prep & Pack (an area used to prepare clean surgical instruments for sterilization and reuse) area did not receive terminal cleaning (a thorough, hospital cleaning focused on eliminating all pathogens from a room, especially in healthcare settings, after use to prevent the spread of infections) (refer to A-0749 finding 9);

10. Cleaning and disinfection of endoscopy GI flexible scopes was not performed in a unidirectional workflow pattern and the GI processing room was not designed to contain contaminants and did not facilitate the highest level of infection control (refer to A-0749 finding 10);

11. Hand hygiene practices were not followed, in two of three medication pass observations (refer to A-0749 finding 11); and

12. Aseptic technique was not followed in one of three medication pass observations (refer to A-0749 finding 12).

Findings

1. On March 3, 2025, at 9:45 a.m., a tour was conducted of the GI Special Procedure room (a dedicated procedure room in a hospital where medical procedures are performed using endoscopes) in the presence of the Director of Surgical Services (DSS) and the Director of Infection Prevention (DIP). The DSS stated the hospital followed Nationally Recognized Infection Control Standards from AAMI (Association for the Advancement of Medical Instrumentation, an organization for advancing the development, and safe and effective use of medical technology). They also followed SGNA (Society of Gastroenterology Nurses and Associates, a professional organization of nurses and associates dedicated to the safe and effective practice of gastroenterology and endoscopy nursing), and AORN (Association of periOperative Registered Nurses, a national organization that supports operating room nurses and defines standards for patient safety).

During the continued tour at 10:14 a.m., a cabinet which contained clean scopes was stored in the procedure room. During a concurrent interview with DSS and DIP, they both stated they did not know the scopes could not be stored in a procedure room and were not aware that the National Standards stipulated they could not be stored in a procedure room.

On March 3, 2025, at 12 p.m., a document review of the National Standards the hospital followed, "ANSI/AAMI ST91:2021 Flexible and semi-rigid endoscope processing in health care facilities". The Standards stipulated, "...11.2.2 Storage Cabinets, cabinets used for storage of flexible endoscopes should be situated in a secure location such as in the clean workroom of the endoscopy processing room in a two-room design or in a separate clean area close to, but not within, the endoscopy procedure room (AORN, 2018e, IX.a [39]). Situating the storage cabinet in a secure location helps protect inventories of flexible endoscopes and supplies that are vulnerable to misappropriation. Locating the storage cabinet in the clean workroom or in a clean area outside of the procedure room helps prevent contamination of processed endoscopes..."

2. On March 3, 2025, at 10:25 a.m., during the tour of the GI Special Procedure room, a concurrent observation and interview were conducted with a Lead Surgical Aide (LSA) who was responsible for cleaning the GI scope storage cabinet located in the procedure room. LSA stated he cleaned the cabinet on a weekly basis, and that he did not remove the clean scopes as he cleaned the interior of the cabinet. LSA stated that to clean the interior of the cabinet, he moved one scope onto a scope hook located within the cabinet while he cleaned the hook that the scope was hanging from. In addition, LSA touched the cleaned scopes with bare hands as he demonstrated the cleaning procedure, and the drip tray beneath the scopes was not removed. LSA stated he did not remove the drip tray to clean it, was not aware what the manufacture cleaning IFUs stipulate and did not have a cleaning log to provide documented evidence when the cabinet was cleaned.

During the same observation, LSA was asked to remove the drip tray, the bottom of the tray contained black particles and the top shelf of the cabinet (the area above the scopes) contained black particles.

On March 3, 2025, at 11:30 a.m., the Scope Cabinet Manufacture IFUs was provided by the facility. The manufacture IFU stipulated, "...Maintenance and Cleaning...Removable Drip Tray: Remove scopes from the cabinet. Then remove drip tray and clean with a non-abrasive liquid cleaner..."

On March 3, 2025, at 12 p.m., a document review of the National Standards the hospital followed, "ANSI/AAMI ST91:2021 Flexible and semi-rigid endoscope processing in health care facilities," was conducted. The Standards stipulated, "...11.2.2 Storage Cabinets..."Cabinets and endoscopes shall be visually inspected to ensure cleanliness when the endoscope is placed into the storage cabinet and also when the endoscope is removed for patient use. An endoscope that is removed from a visibly dirty cabinet or is not dry shall be processed before use (SGNA, 2018 [297]). Storage cabinets should be cleaned in accordance with the manufacturer's IFU, or at least weekly and when visibly soiled..."

3. On March 3, 2025, at 10:40 a.m., during a tour of GI Special Procedure Room and the Operating Room (OR) Main Corridor, an observation was made of a set of double doors located in the OR Corridor, the doors had gaps between the doors and beneath the doors. The doors were directly across from OR 3 where a patient surgical procedure was in process. The DSS who was present during the tour stated behind the doors was the decontamination room of SPD (an area where soiled surgical instruments and GI endoscope cleaning are performed). The DSS and the DIP stated SPD is a negative pressure area.

On March 3, 2025, at 10:40 a.m., the Director of Facilities (DF) was asked to verify the pressure in SPD. DF placed a vacuum pressure gauge (a device used to obtain the pressure in a room) under the door. The vacuum pressure gauge did not consistently maintain a negative pressure reading, the pressure showed a neutral and positive reading. The DF stated, "the pressure changes, it depends on what is happening behind the closed doors," referring to the SPD procedures occurring inside and if the door at the opposite end of SPD was opened.

On March 3, 2025, at 11:30 a.m., a record review of the document titled, "Sterile Processing - Infection Surveillance," provided by the hospital was conducted. The document indicated, "...3. Sterile Processing Environmental Requirement: A. Within the Sterile Processing area, the air exchange must be (a) Negative pressure in the decontamination area..."

An interview with DF was conducted on March 6, 2025, at 4:22 p.m. The DF stated they followed the guidelines from ASHRAE (an international society of heating, refrigerating and air-conditioning professionals).
On March 6, 2925, at 4:30 p.m., a review of ASHRAE 7.1 stipulated, "...Pressure Relationship to Adjacent Areas... Endoscope cleaning room negative pressure)..."

4. On March 3, 2025, at 10:45 a.m., during a tour of the hospital SPD decontamination room, an interview was conducted with a Sterile Processing Technician (SPDT I). SPDT I was asked to explain the brushes that were placed on top of a sink used to clean soiled surgical instruments. SPDT I stated the brushes were used to clean "dirty" surgical instruments. SPDT I was asked how the brushes get cleaned. SPDT I stated, "We don't ever clean the brushes," they use them throughout the day and at the end of the day they get disposed.

On March 3, 2025, at 11:30 a.m., a document review was conducted of the manufacture IFU for the cleaning brushes used by SPD staff to clean soiled surgical instruments. The document was provided by the facility and stipulated, "Cleaning & Disinfection: New, unused brushes are provided non-sterile. Clean brushes after each use and disinfect between cases or daily, at a minimum ..."

On March 4, 2025, at 9:10 a.m., an interview was conducted with SPDT III who verified above interview and stated they do not clean the brushes between use, they dispose them at the end of the day.

5. On March 3, 2025, at 11:10 a.m., SPDT I was asked to explain what the contact time was of the disinfectant (Super Sani Cloth) she used to wipe down a soiled instrument transport cart. She was unable to explain what the contact time was and after surveyor explained it to her, SPDT I stated, "Wow, I never knew that I learned something new."

On March 5, 2025, at 10:50 a.m., a Surgical Technician (ST I) was asked to explain what the contact time was of the Super Sani Cloth the hospital used to clean and disinfect the plastic bins she used to transport GI scopes. ST I was not familiar with the contact time and stated, "It can dry and as long as the 2 minutes is up they can use the plastic bins."

On March 5, 2025, at 3 p.m., a record review of the manufacture IFU of the Super Sani Cloth provided by the DIP stipulated "allow treated surface to remain wet for two (2) minutes. Let air dry."

6. On March 4, 2025, at 11:50 a.m., on March 6, 2025, at 11:55 a.m., multiple employee files were reviewed with the hospital's Human Resources Generalist (HRG). The employee files of SPDT 1, SPDT II, and SPDT III were reviewed. There was no documented evidence that the employees received job specific competencies since 2020.

On March 6, 2025, at 12:45 p.m., a document provided by HRG read, "Associate Competency Policy: it is the policy of (name of facility) to ensure that all associates are competent to perform their job responsibilities. (hospital) will assess the competence of its staff on an on-going basis through a variety of means..."...C. Competence Assessment/Annual Performance Evaluation: Annual evaluation of staff performance will be based on the competency-based performance expectations outlined in the job description...Completion of annual competencies is documented and forwarded to HR..."

On March 6, 2025, at 1 p.m., a review of AAMI ST 79 (the National Standards the hospital followed) stipulated,

"...4.2.2 Sterile processing personnel The responsibility for sterile processing should be assigned to qualified individuals who have demonstrated competence in all aspects of sterile processing, including biohazard transportation, decontamination, preparation, packaging, sterilization, sterile storage, and distribution of sterile medical devices. Qualifications include demonstrated knowledge of and documented competence in a) all aspects of decontamination, including sorting, disassembly/reassembly, manual and mechanical cleaning methods, microbicidal processes, equipment operation, standard and transmission-based precautions, and engineering and work-practice controls; "4.3 Education and training 4.3.1 Sterile processing personnel Sterile processing personnel should receive...b) continuing education at regular intervals to review and update knowledge and skills and to maintain competency and certification; and c) in-service training on all new instrumentation, devices, and equipment. The health care facility should have a written standardized program that includes 1) aspects of education and training related to facility policies and procedures; 2) tools to document that education and training were performed and competency was verified; and 3) the facility's policies and procedures, accepted standards of practice, and manufacturers' recommendations..."

7. On March 5, 2025, at 9:40 a.m., a tour of the hospital SPD Prep and Pack area (a clean area where clean instruments are packaged, prepared for sterilization and patient use), was conducted in the presence of DSS, DIP, and SPDT II. Inspection of sterilized instruments ready for use was performed and revealed the following:

During a concurrent observation and interviews with SPDT II, one Richardson retractor (a handheld surgical instrument with a right-angle blade used to retract, expose, or push tissues, organs, muscles, and bones during surgeries) contained coarse black matter. SPDT II stated, the instrument should have been pulled out of use.

One Straight Kelly (a surgical instrument used to clamp blood vessels and tissues, control bleeding, and manipulate tissues during surgery) contained coarse non-manufacture etching. SPDT II stated it should have been pulled out of use.

One Babcock (a type of surgical instrument used to grasp and hold delicate tissues during surgical procedures) contained coarse non-manufacture etching. SPDT II stated it should have been pulled out of use.

One Curved Metz (an instrument used for fine dissection and cutting of delicate tissues, particularly in areas where precise movements are needed) contained sticky tape residue. SPDT II stated the tape residue should have been completely removed.

On March 5, 2025, at 3 p.m., a document provided by DIP titled, "Sterile Processing - Preparation and Assembly of Surgical Instrumentation" stipulated, "...9. Instruments are carefully inspected for cleanliness, flaws or damage before packaging. (a) Items noted as dirty will be returned for adequate cleaning before proceeding. (b) Damaged items will be removed from service and sent in for repair or replacement..."

8. On March 5, 2025, at 9:50 a.m., during a tour of SPD Prep & Pack, SPDT II was asked for the cleaning log of the autoclave machine (a machine that sterilizes reusable patient surgical instruments). The autoclave chamber contained brown/orange matter. SPDT II stated they did not have a log and they do not clean or maintain the interior chamber.

On March 3, 2025, at 10:15 a.m., a review of the autoclave manufacture IFU was conducted. The document stipulated, "Chamber Routine Cleaning Procedure...Chamber Cleaning Frequency Due to differences in water quality, steam quality, frequency of use and boiler additives, no specific frequency interval is recommended for chamber cleaning. Operators must determine the appropriate cleaning interval based on the local water conditions and chamber appearance..." The document provided a 21 step "Chamber Cleaning Procedure" detailed guide.

During a concurrent interview with the Peri-Op Material Coordinator (MMM), who verified the manufacture IFUs and stated they did not have a cleaning frequency of the autoclave.

9. On March 5, 2025, at 10:25 a.m., during the tour of the SPD Prep and Pack Area, SPDT II was asked when SPD gets terminally cleaned. SPDT II stated it did not get terminally cleaned.

During a concurrent interview on 3/5/25 at 10:25 AM, DSS confirmed that SPD did not get terminally cleaned at the end of the workday.

On March 5, 2025, at 2:30 p.m., an interview was conducted with the Director of Environmental Services (EVSD), who confirmed that terminal cleaning is not performed in SPD.

A review of the National Standards the hospital followed was conducted, standards stipulated, "AORN 2012-2025, 6 Sterile Processing Areas 6.2 Terminally clean sterile processing areas each day the areas are used. Sterile processing personnel conduct critical processes, such as decontaminating, assembling, and sterilizing surgical instrumentation, in support of operating and invasive procedure rooms. As such, the recommendations for terminal cleaning apply in sterile processing areas as in areas where surgical and other invasive procedures are performed. Furthermore, sterile processing areas where decontamination occurs have some of the highest risks for environmental contamination of all perioperative areas. Environmental cleaning in sterile processing areas is critical for reducing the risk of disease transmission from reservoirs of bloodborne pathogens and microorganisms in the decontamination environment."


10. On March 5, 2025, at 10:50 a.m., during a tour of the hospital Special Procedure Unit, a Surgical Technician (ST I) explained the hospital process for disinfecting GI scopes. During the interview the following concerns were identified:

a. The path of travel from SPD, where the disinfection of the GI scopes is performed was not unidirectional. The path of travel required staff to exit the GI procedure room with soiled GI scopes across the OR (a restricted clean area), in through doors that swung out to the OR corridor and across an OR room. Staff then exit through the same doors with soiled GI scopes across the OR unit and to the medivator room (a room used to perform high level disinfection of the GI scopes);

b. Prior to the GI scopes receiving thorough cleaning and disinfecting, the scopes are transported soiled out of double doors into the main corridor of the OR Unit (a restricted, clean area);

c. The soiled scopes are transported through the OR Unit to the medivator room;

d. ST I did not know the contact time of the Super Sani Clothes used to clean and disinfect the plastic bins used to transport the soiled GI scopes; and

c. There was no documented evidence to demonstrate the plastic bins used to transport the GI scopes were re-usable and could be properly disinfected.

During a concurrent interview on 3/5/25 at 10:55 AM, DIP and DSS both agreed the path of travel of transporting the soiled GI scopes from SPD was not unidirectional and not the best infection control practice. In addition, the hospital staff did not provide a policy or a process to guide staff with the GI scope disinfecting process.

On March 5, 2025, at 11:30 a.m., a document titled "Sterile Processing - Infection Surveillance approved 8/2024 (August 2024)," was reviewed and stipulated, "Procedures: 2. Separation of Processing Areas: 1. The flow of processing shall be from contaminated to clean and sterile."

On March 5, 2025, at 12 p.m., a review of the National Infection Control Standards the hospital followed AAMI ST 91 stipulated, "...4.1 General considerations: The processing area should be physically separated from the patient care areas and procedure rooms. The processing area should be designated for processing only and designed to allow for the unidirectional flow of devices from the receipt of new and/or used endoscopes to storage prior to next patient use, including: a) receipt of devices, leak testing; b) cleaning (decontamination); c) inspection; d) storage; and e) disinfection and drying or packaging and sterilization. In all cases, facilities should ensure a unidirectional flow from dirty to clean; conduct an analysis to identify risks; and minimize these risks by policies, procedures, education, and training of processing personnel..."

In addition, the National Standards stipulated, 4.2 Workflow 4.2.1 General considerations: Workflow should be unidirectional from the decontamination area to the clean area and then to the storage area. Workflow patterns should be designed to contain contaminants, prevent damage to endoscopes, and minimize employee exposure to pathogens and toxic chemicals.

11.a. During a medication pass observation on March 4, 2025 at 8:36 a.m., Registered Nurse 2 (RN 2) was observed preparing and administering two medications to Patient 6. RN 2 entered Patient 6's room, performed hand hygiene, donned gloves, and then logged into the computer at Patients 6's bedside. RN 2 proceeded to adjust the window blinds, use the computer, check Patient 6's blood pressure, and scan medications wearing the same pair of gloves. RN 2 then prepared and administered an intravenous (IV, into the vein) medication into Patient 6's IV access line wearing the same pair of gloves.

During an interview on March 4, 2025 at 8:49 a.m., RN 2 verified she did not perform hand hygiene or change gloves before administering the IV medication to Patient 6.

11.b. During a medication pass observation on March 4, 2025 at 9:30 a.m., RN 1 was observed preparing and administering four medications to Patient 7. RN 1 performed hand hygiene and donned gloves outside Patient 7's room. RN 1 proceeded to use the computer and scan medication wearing the same pair of gloves. RN 2 then prepared and administered three IV medications into Patient 7's IV access line wearing the same pair of gloves.

During an interview on March 4, 2025 at 10:09 a.m., RN 1 verified he did not perform hand hygiene or change gloves before administering IV medications to Patient 7. RN 1 stated he was not aware of any hospital policy to do hand hygiene before administering IV medications.

12. During a medication pass observation on March 4, 2025 at 8:36 a.m., Registered Nurse 2 (RN 2) was observed preparing and administering two medications to Patient 6. RN 2 prepared famotidine (generic for Pepcid, a medication to treat acid reflux) 20 milligrams (mg) injection by adding normal saline (NS, salt water) to the famotidine vial. RN 2 did not wipe the vial top with alcohol before adding NS to the vial.

During an interview on March 4, 2025 at 8:49 a.m., RN 2 verified she did not wipe the famotidine vial top with an alcohol swab. RN 2 stated she was supposed to wipe the vial top with an alcohol swab before inserting the needle.

During an interview on March 6, 2025 at 11:57 a.m., the Director of Infection Prevention and Control (IP) stated her expectation is for nurses to perform hand hygiene and put on new gloves before administering IV medications. IP stated her expectation is for the nurse to wipe the vial top with an alcohol swab, allow to dry, and then insert the needle when preparing IV medications.

A review of the facility's policy and procedures titled "Intravenous Site & Device Care," revised April 2024, indicated:
" ...Observe standard precautions: wash your hands before and after, wear gloves ..." and,
" ...Swab port with...alcohol swab..."

A review of the facility's policy and procedures titled "Intravenous Therapy," revised January 2025, indicated:
"...Intravenous Administration of Medication...Aseptic technique must be followed when giving direct IV injection to prevent contamination of the IV system..." and,
"...Aseptic technique must be followed in the preparation of the solution and its administration..." and,
"Starting the IV Infusion: Wash hands and put on gloves..."

A review of the Association for Professionals in Infection Control and Epidemiology (APIC) "Position Paper: Safe Injection, Infusion, and Medication Practices in Health Care," published 2016, indicated:
"...Aseptic Technique...Disinfect the rubber stopper of medication vials with sterile 70% alcohol before inserting a needle..."

Based on observation, interview, and record review, the facility failed to ensure the facility's policy and procedure for maintaining a central venous catheter (CVC, a thin, flexible tube inserted into a large vein near the heart) was implemented, for two of 31 sample patients (Patients 15 and 16) when:

1. For Patient 15, the CVC catheter dressing was not labeled with the date and time the dressing was applied, and the initials of the staff who performed the dressing application. In addition, there was no physician's order for the insertion and use of the CVC; and

2. For Patient 16, the CVC dressing was not changed every seven days.

These failures had the potential for unnecessary line placement, risk for central line-associated bloodstream infections, and other complications for the patients.

Findings:

A tour of the Intensive Care Unit (ICU, a specialized unit where critically ill or injured patients receive intensive medical care and monitoring) was conducted on March 3, 2025, at 10 a.m., with the Director of Risk and Quality (DRQ).

1. A concurrent observation and interview were conducted on March 3, 2025, at 10:02 a.m., in Patient15's room, with the DRQ and ICU Registered Nurse (ICURN) 1. Patient 15 was observed to have a triple lumen CVC (central venous catheter, a thin plastic tubing inserted through a vein) on his right neck. The CVC was observed to have a chlorhexidine (a type of antiseptic) patch and dressing which was observed to not be labeled with the date and time the dressing was applied, and the initials of the staff who performed the dressing application. ICURN 1 stated the CVC is being used to infuse medications to Patient 15. ICURN 1 further stated the dressing of the CVC should have been labeled with the date and time of application and should indicate the initials of the staff who performed the dressing application. The DRQ stated the CVC dressing should have a date and time of application, and the initial of the staff who applied it, in accordance with the facility policy.

A review of Patient 15's record was conducted on March 6, 2025, at 11:45 a.m. with the DRQ.

A facility document titled, "History and Physical," dated March 1, 2025, was reviewed. The document indicated Patient 15 was admitted to the facility on March 1, 2025, with a diagnosis of cardiogenic shock (a life-threatening condition where the heart is unable to pump enough blood to meet the body's needs).

A facility document titled, "KBC [Knowledge Based Charting] Adult Assessment Interventions," dated March 1, 2025, was reviewed. The document indicated, " ...Access/Monitoring Devices...Central Line...Site: Right IJ [internal jugular] CVC...Site Day 1...lumen triple...Indication...meds/IV [intravenous] solutions...securement...secured with adhesive dressing..."

A facility document titled, "History and Physical," dated March 1, 2025, was reviewed. The document indicated, "...patient remained hypotensive requiring pressors (a class of drugs which increases the blood pressure) and a Central line was placed in the ED (Emergency Department) and pt [Patient 15] was started on [brand name of norepinephrine, a medication used to treat life-threatening low blood pressure)..."

There was no documented evidence physician's order was obtained prior to the insertion and use of the CVC on Patient 15.

An interview was conducted on March 6, 2025, at 11:56 a.m., with the DRQ. The DRQ stated a physician's order should have been obtained for the insertion of the CVC in accordance the facility's policy.

A review of the facility's policy and procedure titled, "Intravenous Site & Device Care," dated April 2024, was conducted. The policy indicated, "...IV site access...Obtain or review the provider's order for intravenous (IV) therapy...IV site assessment, maintenance, and documentation...Date and time and initial the dressing..."

2. A concurrent observation and interview were conducted with the DRQ and ICURN 2 on March 3, 2025, at 10:11 a.m., in Patient 16's room. Patient 16 was observed to have a triple lumen CVC on his right neck. The CVC was observed to have a chlorhexidine patch and dressing which was observed to not be labeled with the date and time of application and the initials of the staff who performed the dressing application. ICURN 2 stated the CVC is being used to infuse medications. ICURN 2 was unable to state when the CVC dressing was changed. The DRQ stated the dressing should have been labeled with the application date and time, and the initial of the staff who applied the dressing in accordance with the facility's policy.

A review of Patient 16's record was conducted on March 6, 2025, at 11:13 a.m. with the DRQ. A facility document titled, "History and Physical," dated January 31, 2025, was reviewed. The document indicated Patient 16 was admitted to the facility on January 31, 2025, with a diagnosis of septic shock (a widespread life-threatening infection) likely due to pneumonia (an infection of the lungs).

A facility document titled, "ED Aware Note," dated January 31, 2025, was reviewed. The document indicated, "...Central Line Insertion...The indications for the procedure are volume resuscitation and hemodynamic monitoring..."

A facility document titled, "KBC Adult Assessment Interventions," dated January 31, 2025, through March 4, 2025, was reviewed. There was no documented evidence the dressing for Patient 16's CVC was changed on the following dates:

- On February 8, 2025;
- On February 15, 2025;
- On February 21, 2025; and
- On February 28, 2025.

A concurrent interview and policy review was conducted on March 6, 2025, at 11:40 a.m. with the DRQ and the Intensive Care Unit Director (ICUD). The ICUD stated the facility's policy was not followed when the CVC dressing for Patient 16 was not changed every seven days.

A facility policy and procedure titled, "Prevention of Central Line Associated Infections," dated December 2020, was reviewed. The document indicated, "...Catheter Dressing Changes...Catheter site dressing changes shall occur as follows...Chlorhexidine patch under a clear occlusive dressing (without gauze) should be changed at least every 7 [seven] days and PRN (as needed) if wet, bloody or loose..."

Based on interview and record review, the facility failed to ensure the Director of Surgical Services was qualified by training and experience to manage the Surgical Service Department in accordance with nationally recognized perioperative practices, guidelines, and regulations.

This failure had the potential for operational inefficiencies and lack of oversight in the Surgical Service Department which may result in the provision of unsafe patient care practices.

Findings:

An interview was conducted on March 3, 2025, at 2:50 p.m., with the Director of Surgical Services (DSS). The DSS stated they follow the AORN (Association of Perioperative Registered Nurses, nationally accepted guidelines for the Operating Room [OR]), American Society of Peri Anesthesia Nurses (ASPAN, a professional specialty nursing organization for nurses practicing in pain management) guidelines for the Post Anesthesia (branch of medicine specializing in pain management) Care Unit (PACU, unit where patients recover after surgery). The DSS stated she but does not know the guidelines they follow for the Sterile Processing Department (SPD, an area in the facility where used medical devices are cleaned, disinfected, sterilized, assembled, packaged, stored, and distributed) and Gastroenterology Laboratory (GI Lab, a specialized unit within a hospital focused on diagnosing and treating conditions affecting the digestive system). The DSS further stated she had no experience working in the OR as a registered nurse (RN). The DSS stated her managerial experience in the OR started when she was an interim director in 2024. The DSS stated she has no experience working or managing SPD and GI lab.

A concurrent interview and record review were conducted on March 4, 2025, at 10:46 a.m., with the Human Resources Generalist (HRG). The employee file of the DSS was reviewed and indicated the following:

- On July 11, 2016, the DSS was initially hired by the facility as an RN in the Definitive Observation Unit (DOU, a specialized unit in the facility that provides close monitoring and care to patients who require more attention than a general medical ward but not as intensive as an Intensive Care Unit (ICU, a specialized unit intensive treatment to patients with severe or life-threatening illnesses or injuries, often requiring life support);
- On July 2, 2018, the DSS transferred to the ICU as an ICU RN;
- On February 2, 2020, the DSS transferred to the PACU as Pre-Admission Nurse;
- On March 22, 2022, the DSS transferred to the PACU as a PACU RN;
- On December 12, 2022, the DSS was hired as a Charge nurse in the PACU;
- On April 15, 2024, the DSS was hired as an Interim Director for the Surgical Services; and
- On August 15, 2024, the DSS was hired as the Director for the Surgical Services.

A facility document titled, "Director," dated August 15, 2024, was reviewed with the HRG. The document indicated, "...Job Description: Director...Position Name Director Surgery...The Director of Surgical Services coordinates the nursing care given in all aspects of management for the Surgical Services department. This includes the Operating Room, Post Anesthesia Care Unit, Pre-Operative Preparation Area, Sterile Processing Unit and G.I. Lab...Regulatory Requirement (Licensure and Credentials)...Experience...Minimum of three years of prior managerial experience required with demonstrated administrative and leadership ability. Minimum of five year's operating room experience with the ability to scrub or circulate when needed." During a concurrent interview, the HRG stated there was no documentation the DSS was trained or precepted to scrub or circulate in the OR. The HRG stated there was no documentation the DSS had three years of managerial experience and five years of operating room experience. The HRG stated there was no documentation the DSS had experience working or managing the OR, SPD and GI Lab. The HRG further stated there was no documentation the DSS was onboarded, trained, nor precepted (the process through which a provider gains experience and/or training on new skills and knowledge) on the care of patients in the OR and GI lab.

A concurrent interview and record review was conducted on March 4, 2025, at 11:08 a.m., with the Chief Nurse Executive (CNE) and HRG. A facility document titled, "Director," dated August 15, 2024, was reviewed. The CNE stated DSS is not qualified to be the Surgical Services Director based on the requirements stated on the job description.

A review of the AORN's Position Statement titled, "Guiding Principles for the Surgical Services Director Role," dated 2023, was conducted. The document indicated, "...AORN believes that the Director of Surgical Services should be a registered nurse with perioperative experience...The role of the Director is multi-faceted, requiring clinical experience, knowledge of the art and science of nursing, expertise that supports broad-level thinking, and an understanding of the fiduciary responsibilities of providing safe, quality patient care in the surgical arena...Principles...The Director of Surgical Services should have clinical perioperative experience and expert skills and knowledge in the practice of perioperative nursing..."

Based on observations, interviews, and record reviews, the hospital failed to provide surgical services in a well-organized manner, in accordance with acceptable standards of practice and in a manner to prevent the risk of cross contamination, when:

1. Surgical brushes used to clean soiled surgical instruments were not cleaned between use;

2. Two of two surgical processing staff (SPD Tech 1 & 2) did not adhere to the contact time (the amount of time a disinfectant needs to remain wet on a surface to effectively kill germs and achieve the desired level of sanitation) of the Super Sani wipes (cleaning and disinfectant wipes);

3. Three of three SPD staff employee files did not contain documented evidence they received job specific competencies;

4. Four sterilized and ready to use surgical instruments contained the following: one instrument contained black non-smooth matter, 1- contained sticky residue, & two instruments contained non-manufacture etching that was course to touch;

5. The autoclave (a machine used to sterilize surgical instruments) was not cleaned and maintained according to manufacture IFU;

6. The hospital Sterile Processing Department Prep & Pack (an area used to prepare clean surgical instruments for sterilization and reuse) area did not receive terminal cleaning (a thorough, hospital cleaning focused on eliminating all pathogens from a room, especially in healthcare settings, after use to prevent the spread of infections); and

7. The hospital SPD decontamination room (a room used to clean and disinfect re-usable patient surgical instruments) did not consistently maintain negative pressure, (the air pressure inside the room is lower than the air pressure outside the room. Which means that when the door is opened, potentially contaminated air or other dangerous particles from inside the room cannot flow outside into non-contaminated areas). The doors were opened frequently, which opened directly into the Operating Room (OR) corridor which faced OR 3 (a room that was in use during a patient surgical procedure). In addition, the doors had gaps beneath and between the doors and the doors did not open in a unidirectional workflow pattern.

Findings:

1. On March 3, 2025, at 10:45 a.m., during a tour of the hospital SPD decontamination room, an interview was conducted with a Sterile Processing Technician (SPDT I). SPDT I was asked to explain the brushes that were placed on top of a sink used to clean soiled surgical instruments. SPDT I stated the brushes were used to clean "dirty" surgical instruments. SPDT I was asked how the brushes get cleaned. SPDT I stated, "We don't ever clean the brushes", they use them throughout the day and at the end of the day they get disposed.

On March 3, 2025, at 11:30 a.m., a document review was conducted of the manufacture IFU for the cleaning brushes used by SPD staff to clean soiled surgical instruments. The document was provided by the facility and stipulated, "Cleaning & Disinfection: New, unused brushes are provided non-sterile. Clean brushes after each use and disinfect between cases or daily, at a minimum..."

On March 4, 2025, at 9:10 a.m., an interview was conducted with SPDT III who verified above interview and stated they do not clean the brushes between use, they dispose them at the end of the day.

2. On March 3, 2025, at 11:10 a.m., SPDT I was asked to explain what the contact time was of the disinfectant (Super Sani Cloth) she used to wipe down a soiled instrument transport cart. She was unable to explain what the contact time was and after surveyor explained it to her, SPDT I stated, "Wow, I never knew that I learned something new."

On March 5, 2025, at 10:50 a.m., a Surgical Technician (ST I) was asked to explain what the contact time was of the Super Sani Cloth the hospital used to clean and disinfect the plastic bins she used to transport GI scopes. ST I was not familiar with the contact time and stated, "It can dry and as long as the 2 minutes is up they can use the plastic bins."

On March 3, 2025, at 3 p.m., a record review of the manufacture IFU of the Super Sani Cloth provided by the DIP stipulated "allow treated surface to remain wet for two (2) minutes. Let air dry."

3. On March 3, 2025, at 11:50 a.m., and on March 6, 2025, at 11:55 a.m., multiple employee files were reviewed with the hospital's Human Resources Generalist (HRG). The employee files of SPDT 1, SPDT II, and SPDT III were reviewed. There was no documented evidence that the employees received job specific competencies since 2020.

On March 6, 2025, at 12:45 p.m., a document provided by HRG read, "Associate Competency Policy: it is the policy of (name of facility) to ensure that all associates are competent to perform their job responsibilities. (hospital) will assess the competence of its staff on an on-going basis through a variety of means...C. Competence Assessment/Annual Performance Evaluation: Annual evaluation of staff performance will be based on the competency-based performance expectations outlined in the job description...Completion of annual competencies is documented and forwarded to HR..."

On March 6, 2025, at 1 p.m., a review of AAMI ST 79 (the National Standards the hospital followed) stipulated,

"...4.2.2 Sterile processing personnel The responsibility for sterile processing should be assigned to qualified individuals who have demonstrated competence in all aspects of sterile processing, including biohazard transportation, decontamination, preparation, packaging, sterilization, sterile storage, and distribution of sterile medical devices. Qualifications include demonstrated knowledge of and documented competence in a) all aspects of decontamination, including sorting, disassembly/reassembly, manual and mechanical cleaning methods, microbicidal processes, equipment operation, standard and transmission-based precautions, and engineering and work-practice controls...4.3 Education and training 4.3.1 Sterile processing personnel Sterile processing personnel should receive...b) continuing education at regular intervals to review and update knowledge and skills and to maintain competency and certification; and c) in-service training on all new instrumentation, devices, and equipment. The health care facility should have a written standardized program that includes 1) aspects of education and training related to facility policies and procedures; 2) tools to document that education and training were performed and competency was verified; and 3) the facility's policies and procedures, accepted standards of practice, and manufacturers' recommendations..."

4. On March 5, 2025, at 9:40 a.m., a tour of the hospital SPD Prep and Pack area (a clean area where clean instruments are packaged, prepared for sterilization and patient use), was conducted in the presence of DSS, DIP, and SPDT II. Inspection of sterilized instruments ready for use was performed and revealed the following:

- During a concurrent observation and interviews with SPDT II, one Richardson retractor ("a handheld surgical instrument with a right-angle blade used to retract, expose, or push tissues, organs, muscles, and bones during surgeries") contained coarse black matter. SPDT II stated, the instrument should have been pulled out of use;

- One Straight Kelly ("a surgical instrument used to clamp blood vessels and tissues, control bleeding, and manipulate tissues during surgery") contained coarse non-manufacture etching. SPDT II stated it should have been pulled out of use;

- One Babcock ("a type of surgical instrument used to grasp and hold delicate tissues during surgical procedures") contained coarse non-manufacture etching. SPDT II stated it should have been pulled out of use; and

- One Curved Metz ("used for fine dissection and cutting of delicate tissues, particularly in areas where precise movements are needed") contained sticky tape residue. SPDT II stated the tape residue should have been completely removed.

On March 5, 2025, at 3 p.m., a document provided by DIP titled, "Sterile Processing - Preparation and Assembly of Surgical Instrumentation" stipulated, "...9. Instruments are carefully inspected for cleanliness, flaws or damage before packaging. (a) Items noted as dirty will be returned for adequate cleaning before proceeding. (b) Damaged items will be removed from service and sent in for repair or replacement..."

5. On March 5, 2025, at 9:50 a.m., during a tour of SPD Prep & Pack, SPDT II was asked for the cleaning log of the autoclave machine (a machine that sterilizes reusable patient surgical instruments). The autoclave chamber contained brown/orange matter. SPDT II stated they did not have a log and they do not clean or maintain the interior chamber.

On March 5, 2025, at 10:15 a.m., a review of the autoclave manufacture IFU was conducted. The document stipulated, "...Chamber Routine Cleaning Procedure...Chamber Cleaning Frequency Due to differences in water quality, steam quality, frequency of use and boiler additives, no specific frequency interval is recommended for chamber cleaning. Operators must determine the appropriate cleaning interval based on the local water conditions and chamber appearance..." The document provided a 21 step "Chamber Cleaning Procedure" detailed guide.

During a concurrent interview with the Peri-Op Material Coordinator (MMM), who verified the manufacture IFUs and stated they did not have a cleaning frequency of the autoclave.

6. On March 5, 2025, at 10:25 a.m., during the tour of the SPD Prep and Pack Area, SPDT II was asked when SPD gets terminally cleaned. SPDT II stated it did not get terminally cleaned.

During a concurrent interview on March 5, 2025, at 10:25 a.m., the DSS confirmed that SPD did not get terminally cleaned at the end of the workday.

On March 5, 2025, at 2:30 p.m., an interview was conducted with the Director of Environmental Services (EVSD), who confirmed that terminal cleaning is not performed in SPD.

A review of the National Standards the hospital followed was conducted, standards stipulated, "...AORN 2012-2025, 6 Sterile Processing Areas 6.2 Terminally clean sterile processing areas each day the areas are used. Sterile processing personnel conduct critical processes, such as decontaminating, assembling, and sterilizing surgical instrumentation, in support of operating and invasive procedure rooms. As such, the recommendations for terminal cleaning apply in sterile processing areas as in areas where surgical and other invasive procedures are performed. Furthermore, sterile processing areas where decontamination occurs have some of the highest risks for environmental contamination of all perioperative areas. Environmental cleaning in sterile processing areas is critical for reducing the risk of disease transmission from reservoirs of bloodborne pathogens and microorganisms in the decontamination environment..."

7. On March 3, 2025, at 10:40 a.m., during a tour of GI Special Procedure Room and the Operating Room (OR) Main Corridor, an observation was made of a set of double doors located in the OR Corridor, the doors had gaps between the doors and beneath the doors. The doors were directly across from OR 3 where a patient surgical procedure was in process. DSS who was present during the tour stated behind the doors was the decontamination room of SPD (an area where soiled surgical instruments and GI endoscope cleaning are performed). DSS and DIP stated SPD is a negative pressure area.

On March 3, 2025, at 10:40 a.m., the Director of Facilities (DF) was asked to verify the pressure in SPD. DF placed a vacuum pressure gauge (a device used to obtain the pressure in a room) under the door. The vacuum pressure gauge did not consistently maintain a negative pressure reading, the pressure showed a neutral and positive reading. DF stated, "the pressure changes, it depends on what is happening behind the closed doors" referring to the SPD procedures occurring inside and if the door at the opposite end of SPD was opened.

On March 3, 2025, at 11:30 a.m., a record review was provided by the hospital, the document titled, "Sterile Processing - Infection Surveillance...3. Sterile Processing Environmental Requirement: A. Within the Sterile Processing area, the air exchange must be (a) Negative pressure in the decontamination area..."

An interview with DF was conducted on March 6, 2025, at 4:22 p.m., the DF stated they followed the guidelines from ASHRAE (an international society of heating, refrigerating and air-conditioning professionals).

On March 6, 2025, at 4:30 p.m., a review of ASHRAE 7.1 stipulated "...Pressure Relationship to Adjacent Areas...Endoscope cleaning room negative pressure)..."