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Based on observation, interview, and record review, the facility failed to ensure surgical services were provided in a well-organized manner, in accordance with acceptable standards of practice, to prevent the risk of cross contamination (the transfer of harmful bacteria from one person or object to another), when:

1. The steam sterilizer (a machine that utilize high-temperature steam and pressure to kill germs) was not maintained in accordance with the manufacturer's instruction for use (IFU) and brown staining, black matter, and whitish/grey residue were observed throughout the chamber (the internal portion of the sterilizer) for one of three sampled reprocessing (a process used to remove soil and germs and/or inactivate germs) machines (Sterilizer 3) (Refer to A0951);

2a. Singled-use (an item designed to be used once and then discarded) cleaning sponges were not being properly used for multiple surgical cases in accordance with the manufacturer's IFU, for two of two sampled surgical cases (Refer to A0951);

2b. Hand-held cleaning brushes (a special brush used to clean reusable surgical instruments) were not being cleaned after each use in accordance with the manufacturer's IFU, for two of two sampled surgical cases (Refer to A0951);

3. Endoscopes were not stored in clean and properly maintained storage units in accordance with the manufacturer's IFU for one of three sampled storage cabinets (Storage Cabinet 2) (Refer to A0951);

4. Previously reprocessed instruments were observed with orange/red matter, brown staining, discoloration, scratches, pitting (the formation of small, localized depressions or holes), etching (an engraving on the surface of the instrument), and white residue for two of two sampled surgical instrument tray sets (Tray Set 1 and Tray Set 2) (Refer to A0951);

5. Terminal cleaning procedures (a thorough environmental cleaning procedure that is performed at the end of each day when the area is being used) were not implemented per hospital protocol and peeling red tape, medical device stickers, black sticky substances, medical tape, and scattered black/brown spots were observed throughout the floor for one of two sampled reprocessing workrooms (Sterile Processing Department -SPD, an area within a health care facility that processes and controls medical supplies, devices, and equipment) (Refer to A0951);

6. The surgical consent form (a legal document that a patient/patient's representative signs to give permission for a surgery to be performed) did not indicate the date and time that the physician discussed the surgical procedure with the patient's representative in accordance with the hospital's P&P for one of 30 sampled patients (Patient 13) (Refer to A0951);

7. Hand hygiene (the practice of cleaning one's hand to remove dirt and germs to prevent the spread of infections) was not performed after handling soiled surgical instruments in accordance with the hospital's policy and procedure (P&P) for one of four sampled Sterile Processing Technicians (SPD Tech 1) (Refer to A0951);

8. The hospital did not ensure eyewash stations were not installed in locations that required employees to perform emergency flushing of the eyes in decontamination (the process of removing or neutralizing germs) sinks for one of two sampled reprocessing workrooms (SPD decontamination workroom) (Refer to A0951); and

9. Sterile supply packs were stored on shelving over an unmaintained drain with exposure to moisture and insects (Refer to A0951).

The cumulative effects of these systemic problems had the potential for cross contamination which may result in longer hospitalization, delay in healing, and infection in patients on whom the surgical instruments are used.

Based on observation, interview, and record review, the hospital failed to ensure the needs of all patients requiring surgical services and gastroenterology services (GI, the study, diagnosis, and treatment of disorders that deal with the digestive system) including the storage of flexible endoscopes (a reusable instrument used to inspect and treat the interior portions of the body) were met when:

1. The steam sterilizer (a machine that utilize high-temperature steam and pressure to kill germs) was not maintained in accordance with the manufacturer's instruction for use (IFU) and brown staining, black matter, and whitish/grey residue were observed throughout the chamber (the internal portion of the sterilizer) for one of three sampled reprocessing (a process used to remove soil and germs and/or inactivate germs) machines (Sterilizer 3);

2a. Singled-use (an item designed to be used once and then discarded) cleaning sponges were not being properly used for multiple surgical cases in accordance with the manufacturer's IFU, for two of two surgical cases;

2b. Hand-held cleaning brushes (a special brush used to clean reusable surgical instruments) were not being cleaned after each use in accordance with the manufacturer's IFU, for two of two surgical cases;

3. Endoscopes were not stored in clean and properly maintained storage units in accordance with the manufacturer's IFU, for one of three sampled storage cabinets (Storage Cabinet 2);

4. Previously reprocessed instruments were observed with orange/red matter, brown staining, discoloration, scratches, pitting (the formation of small, localized depressions or holes), etching (an engraving on the surface of the instrument), and white residue for two of two sampled surgical instrument tray sets (Tray Set 1 and Tray Set 2);

5. Terminal cleaning procedures (a thorough environmental cleaning procedure that is performed at the end of each day when the area is being used) were not implemented per hospital protocol and peeling red tape, medical device stickers, black sticky substances, medical tape, and scattered black/brown spots were observed throughout the floor for one of two sampled reprocessing workrooms (Sterile Processing Department -SPD, an area within a health care facility that processes and controls medical supplies, devices, and equipment);

6. The surgical consent form (a legal document that a patient/patient's representative signs to give permission for a surgery to be performed) did not indicate the date and time that the physician discussed the surgical procedure with the patient's representative in accordance with the hospital's policy and procedure (P&P), for one of 30 sampled patients (Patient 13);

7. Hand hygiene (the practice of cleaning one's hand to remove dirt and germs to prevent the spread of infections) was not performed after handling soiled surgical instruments in accordance with the hospital's P&P, for one of four sampled Sterile Processing Technicians (SPD Tech 1);

8. The hospital did not ensure eyewash stations were not installed in locations that required employees to perform emergency flushing of the eyes in decontamination (the process of removing or neutralizing germs) sinks for one of two sampled reprocessing workrooms (SPD decontamination workroom);

9. Sterile supply packs were stored on shelving over an unmaintained drain with exposure to moisture and insects; and

10. The hospital did not follow the manufacturer's IFU on daily and weekly routine maintenance services for one of one sampled washer/disinfector (a machine that use a combination of mechanical, chemical, and thermal processes to reprocess surgical instruments).

These failures had the potential for injury and prolonged hospitalization, for 30 of 30 sampled patients, and jeopardize the health and welfare of other patients experiencing surgical procedures.

Findings:

On April 2, 2025, at 1:49 p.m., an immediate jeopardy (IJ- a situation that had threatened or was likely to threaten the health and safety of a patient) situation was called in the presence of the Chief Nursing Officer (CNO) and the Director of Quality and Infection Prevention (DQIP). The CNO and the DQIP were verbally notified of failure of the hospital not implementing safe surgical practices when the steam sterilizer (autoclave, a machine used to kill germs on surgical instruments) was not clean and maintained in accordance with the manufacturer's IFU; multiple reusable surgical instruments were not clean and/or damaged; single-use cleaning sponges were being used for multiple surgical cases; hand-held brushes used to clean the reusable surgical instruments were not being cleaned after each use; and endoscopes were not stored in a clean and properly maintained storage cabinet in accordance with the manufacturer's IFU.

On April 3, 2025, at 5:52 p.m., the hospital provided an IJ removal plan (RP). The RP included the following components:
-Sterilizer cleanliness
1. Daily sterilizer log was implemented for sterilizers. SPD technicians trained to complete checklist/log including chamber inspections, door/gasket, clean drain, printer, and external wipe down. Flush of the chamber drain will be conducted weekly. Purpose, expectations, and completion of the log provided.
2. The policy "OR (operating room)-Autoclave Maintenance" was reviewed and revised to align with clinical standards, manufacturer specifications, and IFU. Policy review included sterilizer chamber inspection, door and gasket inspection, chamber drain strainer cleaning, printer and paper supply check, and exterior surface wipe down.
3. Education provided to SPD technicians/staff regarding daily logs, inspection of sterilizers, and chamber drain cleaning. Expectation that all SPD technicians and staff complete training upon the start of their shift until 100% of staff have completed training. Education to be completed in initial hire and annual competencies (an evaluation of knowledge, skills, and experience to perform job duties correctly) going forward.

-Surgical Instrument Integrity:
1. In SPD, staff instructed regarding visual inspection of instrumentation after washing for any breech in the integrity of the instruments.
a. If an instrument is damaged, then it will be removed and replaced with another instrument to complete the tray, and the instrument held for evaluation by the third-party vendor who specializes in instrumentation to determine if the instrument should be refurbished or discarded.
b. If any instruments in the container are contaminated (potentially infectious and/or soiled with bone, blood, residue), then the whole container will be reprocessed.
2. Water quality will be reevaluated on a periodic basis (quarterly), or more frequently when a trend is noted with the instruments. Completed 3/17/25, next due May 2025, or sooner if indicated.
3. Reinforce "Stop the Line" (an immediate stop in a procedure/process if a potential safety risk or error have been identified) escalation for SPD and OR staff whenever a sterile instrument is identified of questionable integrity. If an instrument is identified, the tray will be pulled (will not be available for patient use), and all instruments set aside for evaluation by the SPD Director/CNO/RM prior to reprocessing. Once evaluated, instruments will be reprocessed (if applicable).
4. Vendor contacted for instrument cleaning/refurbishing (3rd party vendor) to come evaluate instrumentation and determine if instrumentation can be refurbished for use versus discarded. Scheduled for 4/9/25 and 4/12/25 for initial evaluation, followed by regularly scheduled interval based upon identified need.
5. Infection Prevention will conduct a random audit of sterilized (germ free) trays to assure instrument integrity. Number= # of instruments with breech integrity, Denominator = # of instruments reviewed. Goal is 0% with identified issue with integrity. Data will be collected monthly and reported quarterly to the Governing Board (a committee that manages or control the hospital's activities) until compliance is achieved and sustained for a period of 3 (three) months, then transition to a periodic review.

-Sponge utilization in Decontamination Department
1. IFU for sponge products was reviewed and practice was changed from current practice to utilization of one sponge to be used for single OR case as long as the sponge remains intact. (Note: Single case means one patient with multiple cases).
2. Signage was posted in the decontamination area. Education provided to SPD technicians/staff regarding new changes.
3. Education provided to SPD technicians/staff regarding single-use sponge use. Expectation that all SPD technicians/SPD staff complete training upon the start of their shift until 100% of staff have completed the training. Education to be included in initial hire and annual competencies going forward.
4. Infection prevention will audit the number of sponges used with the number of cases daily. Numerator =of sponges per month, Denominator =of cases per month. Goal-number of cases and sponges match within 5 (five) %. Data will be Data will be collected monthly and reported quarterly to the Governing Board until compliance is achieved and sustained for a period of 3 months, then transition to a periodic review.

-Brush utilization in Decontamination Department
1. IFU for brush products was reviewed and practice was changed from current practice to utilization of one brush to be used for single OR case as long as the brush remains intact. (Note: Single case means one patient with multiple cases).
2. Signage was posted in the decontamination area. Education provided to SPD technicians/staff regarding new changes.
3. Education provided to SPD technicians/staff regarding single-use brush use. Expectation that all SPD technicians/SPD staff complete training upon the start of their shift until 100% of staff have completed the training. Education to be included in initial hire and annual competencies going forward.
4. Infection prevention will audit the number of brushes used compared to the number of cases. with the number of cases daily. Numerator =of brushes used per month, Denominator =of cases per month. Goal-number of cases and brushes match within 5 %. Data will be Data will be collected monthly and reported quarterly to the Governing Board until compliance is achieved and sustained for a period of 3 months, then transition to a periodic review.

-GI Scope Cabinet base tray integrity
1. The scopes were removed from the scope cabinet and cabinet was terminally cleaned (a cleaning process which includes specialized chemicals to eliminate germs).
2. The scopes were all reprocessed.
3. The bottom tray of the cabinet was removed and replaced with an intact tray.
4. The cabinet and base were terminally cleaned prior to replacing the scopes.
5. Scopes were replaced into the scope cabinet.
6. Additional tray will be ordered for back-up
7. Infection prevention will conduct a random audit of cabinet/tray to assure the integrity. Numerator =of observation with no breech in cabinet/tray integrity. Denominator =of observations completed. Goal is 0% with identified issue with integrity. Data will be Data will be collected monthly and reported quarterly to the Governing Board until compliance is achieved and sustained for a period of 3 months, then transition to a periodic review.

On April 3, 2025, at 5:52 p.m., the RP for the IJ was reviewed and was found acceptable.

On April 4, 2025, at 4:24 p.m., the immediate jeopardy situation was removed onsite in the presence of the CNO, Chief Executive Officer (CEO), and the DQIP, after the RP was verified onsite as implemented through observation, interviews, and record reviews, as evidenced by the cleanliness of the sterilizer, cleanliness and integrity of the surgical instruments, cleanliness of the endoscope storage cabinet, implementation of single case use for cleaning products, staff knowledge of the manufacturer's IFU, and a tracking system to prevent future reprocessing breeches.

1. An interview was conducted with the DQIP on April 1, 2025, at 8:45 a.m., in the conference room (CR). The DQIP stated the hospital followed the following nationally recognized guidelines:

A. Centers for Disease Control and Prevention (CDC, the national public health agency of the United States);

B. Association of periOperative Registered Nurses (AORN, a nationally recognized infection control guidelines for perioperative areas);

C. Occupational Safety and Health Administration (OSHA, a large regulatory agency of the United States Department of Labor); and

D. ANSI/AAMI ST79 (2017) (American National Standards/Association for the Advancement of Medical Instrument, standards development organizations) Comprehensive Guide to Steam Sterilization and Sterility Assurance in Healthcare Facilities.

A concurrent observation and interview were conducted with the DQIP on April 1, 2025, at 8:55 a.m., in the SPD clean workroom. Three sterilizer machines were observed. There was brown staining, black matter, and whitish/grey residue observed throughout Sterilizer 3's chamber walls. The DQIP stated the sterilizer had "some discoloration." A request was made to interview the SPD Supervisor. The DQIP stated the SPD Supervisor was away from the medical center and was not available for interview. The DQIP stated, "The SPD Supervisor reports to me."

An interview was conducted with the Lead Sterile Processing Technician (Lead SPDT 1) on April 1, 2025, at 9:05 a.m., in the SPD clean workroom. Lead SPDT 1 stated the SPD staff did not provide routine maintenance or cleaning services for the sterilizer's machine chamber and the hospital did not have documentation to show that the chamber strainer had been inspected or routinely cleaned.

An interview and record review were conducted with the CNO and Lead SPDT 2 on April 2, 2025, at 8:30 a.m., in the conference room. The facility's document titled, "AMSCO 400 Series Medium Steam Sterilizers: Operator Manual," dated 2019, indicated, " ...8.3.1 Clean Chamber Drain Strainer: Recommended Frequency: The chamber drain strainer must be cleaned at least once a day...8.3.2 Flush Chamber Drain...The chamber drain should be cleaned once a week...Drain Cleaning Method...6. Rinse the bottom of the chamber with a small amount of water to prevent detergent residue from baking onto the surface..." Lead SPDT 2 stated she had reviewed the manufacturer's IFU, and she was not aware that the hospital expected the SPD staff to perform daily or weekly cleaning of the sterilizers. Lead SPDT 2 confirmed the SPD staff were not performing daily or weekly maintenance/cleaning services for the hospital's sterilizers.

A concurrent interview and review of the facility's document titled, "Field Service Report" (a record that shows the activities and outcomes of a service visit, such as repairs, installations, or maintenance) were conducted with the Biomedical Director (Biomed Director) on April 3, 2025, at 3:45 p.m., in the conference room. The Biomed Director stated his department was responsible for the hospital's field service reports. The report showed the following: "Work date: 2/21/2025 [February 21, 2025], Type: Chamber cleaning. Notes: Serviced machine. Could not run dart [Daily Air Removal Test, a process used to ensure effective sterilization because air pockets interfere with steam penetration and contact with the items being sterilized, potentially leading to failure of the sterilization process] due to their being a problem with the steam. Unit has been down for over 2 (two) weeks ..." The Biomed Director confirmed the manufacturer had cleaned Sterilizer 3's chamber on February 21, 2025. The Biomed Director stated the end users (SPD staff) were responsible for daily and weekly routine care of the sterilizers. The Biomed Director stated he was not aware the hospital had been experiencing problems with the steam system. The Biomed Director confirmed that the lack of steam could interfere with the sterilization process.

The review of the hospital's P&P titled, "OR (Operating Room)-Autoclave Maintenance," reviewed March 2025, was conducted. The P&P indicated, " ...V. Procedure: SPD personnel will clean sterilizer daily as follows: Clean chamber drain strainer...Once a week, or as needed, the interior of the sterilizer is cleaned as follows: Flush chamber drain...As needed, the SPD personnel will: Clean sterilizer's chamber..."

2. A tour of the SPD decontamination workroom was conducted on April 1, 2025, at 11:30 a.m., with the DQIP. The decontamination sink was observed to have three compartments (Sink 1, Sink 2, and Sink 3). Three surgical cleaning sponges, three toothbrush-style cleaning brushes, and two channel style (used to clean the inside of soiled instruments) cleaning brushes were observed on top of the decontamination sink. SPD Tech 1 was observed standing in front of Sink 1 and using a surgical cleaning sponge to wipe red soil and debris from a surgical instrument. SPD Tech 1 placed the instrument into Sink 2 and proceeded to pick up another instrument from Sink 1. SPD Tech 1 was observed cleaning the surface of the surgical instrument with a toothbrush-style brush and then proceeded to clean the inside of the instrument with a channel-style brush.

An interview was conducted with the DQIP and SPD Tech 1 on April 1, 2025, at 11:45 a.m., in the SPD decontamination area. SPD Tech 1 stated the red soil on the instrument was blood. SPD Tech 1 stated sponges and brushes were not cleaned between cases and the cleaning products were used throughout the day and discarded at the end of the day. The DQIP stated she was not familiar with the cleaning brushes and cleaning sponges that were used in the decontamination workroom. The DQIP stated, "Let me check."

A concurrent interview and record review were conducted with the CNO, on April 1, 2025, at 3:45 p.m., in the conference room. The following documents were reviewed,

-The hospital's undated document titled, "DuraSponge, Cleaning Sponge," indicated, "...Special Warnings and Cautions: Single use only;" and

-The hospital's undated document titled, "General Instrument Cleaning Brushes," indicated, "Cleaning & [and] Disinfection [a cleaning process using chemicals to kill germs]: Clean brushes after each use and disinfect between cases or daily, at a minimum..."

The CNO stated, according to the manufacturer's guidelines, the brushes should have been cleaned after each use and the sponges were designed for a single use case. The CNO stated, "Let me take a picture of the guidelines."

An observation was conducted with the CNO and the DQIP on April 2, 2025, at 9:53 a.m., in the SPD decontamination workroom. Two sponges and one toothbrush-style cleaning brush were observed on top of the decontamination sink. SPD Tech 1 was observed wiping red soil and debris from instruments with a surgical cleaning sponge.

During an interview, conducted with SPD Tech 1 on April 2, 2025, at 10:05 a.m., in the SPD decontamination workroom, SPD Tech 1 stated he had used the cleaning sponges today (April 2, 2025) for multiple patient cases. SPD Tech 1 stated he had not been trained nor educated to dispose of the sponge after each case. SPD Tech 1 confirmed the cleaning sponges were used for all the surgical cases throughout the day and were replaced if the sponge was damaged.

During a follow-up interview conducted with the CNO on April 3, 2025, at 1:25 p.m., in the conference room, the CNO stated the hospital's practice is to, "Meet all manufacturer's guidelines or to exceed them (manufacturer's IFU). The CNO stated additional education for the SPD staff was needed to ensure SPD staff followed the manufacturer's IFU on sponge and brush products used in the decontamination workroom.

The review of the hospital's P&P tilted, "OR-Instrument Processing," revised March 2025, indicated "...V. Procedure...Decontamination Personnel will wash, disinfect, and process all instruments, equipment, and supplies brought to this area following the manufacture's IFU and recommendations..."

3. An observation was conducted on April 2, 2025, at 11:09 a.m., of the endoscope storage room with the Lead Gastroenterology Technician (GI Tech) and the DQIP. Scope Cabinet 2 was observed with the drip tray (a removable tray designed to collect residual moisture that may drip during the storage process) to be cracked, and the tray contained a sticky black residue. A thick pale-white material was observed on both ends of the tray. The material was not smooth nor evenly applied. The material was observed to contain black particles, thick grey fuzzy matter, and debris. Twelve scopes were observed hanging freely in the cabinet and were labeled "Clean."

An interview was conducted with the GI Tech on April 2, 2025, at 11:20 a.m., in the endoscope storage room. The GI Tech stated the drip tray had cracked, and the hospital repaired the drip tray with a caulking material. The GI Tech stated the grey fuzzy matter was dust and the black specks was debris. The GI Tech stated the material was not easy to clean and/or disinfect. The GI Tech stated he did not know why the department continued to use the damage cabinet for the storage of reprocessed endoscopes. The GI Tech stated the scope cabinet should have been taken out of service until the drip tray had been replaced to prevent the risk of cross-contamination (the unintentional transfer of harmful germs or other from one surface or object to another). The DQIP disagreed with the GI Tech and stated the drip tray could have been effectively clean and disinfected. The DQIP stated she did know not if the scope cabinet's manufacturer had recommended the use of the caulking material that had been applied to the drip tray.

The review of the manufacturer's manual titled, "Olympus Reprocessing Manual," dated 2014, was conducted. The manual indicated the following instructions for use, "...8.2 Storing the disinfected endoscope and accessories: Warning: Proper storage procedures are as important as proper reprocessing procedures in maintaining good infection control practices...Be sure the endoscope storage cabinet is properly maintained, clean, dry, and well ventilated..."

4. A concurrent interview and inspection of surgical trays were conducted with Lead SPDT 1 and the DQIP, on April 1, 2025, at 9:01 a.m., in the SPD clean workroom. Two surgical tray sets were inspected. Lead SPDT 1 stated the surgical tray sets contained reusable surgical instruments that had been "previously reprocessed and were ready for patient use." The following were observed:

-Tray Set 1 contained 66 surgical instruments, dated March 26, 2025. 24 of 66 sampled instruments were of concern upon inspection of the surgical tray set. Two instruments had multiple scratches; nine instruments were discolored; five instruments had multiple white spots; seven instruments had brown staining, and one instrument contained etchings; and

-Tray Set 2 contained 85 surgical instruments, dated March 31, 2025. 23 of 85 sampled instruments were of concern upon inspection of the tray set. Five instruments contained pitting; 10 instruments had brown staining; one instrument contained orange/red matter, four instruments had etchings; one instrument had white residue; and two instruments contained pitting.

Lead SPDT 1 stated the hospital have been discarding all instrument containing etching. Lead SPDT 1 stated the instruments with etchings should have been remove from the tray set prior to the sterilization process. Lead SPDT 1 stated the orange/red matter was "rust" and the rust was "missed" during the inspection process. Lead SPDT 1 did not provide an explanation for the multiple brown stained instruments. Lead SPDT 1 stated if one reprocessed instrument in a tray set contained rust, the tray set would not be acceptable for patient use and "The entire surgical tray set would have to be returned to the SPD's decontamination workroom for reprocessing." The DQIP did not provide an explanation for the identified damaged and/or stained instruments.

A concurrent observation and interview were conducted with the STERIS Technician/Outside Contractor (SOC), on April 4, 2025, at 10:15 a.m., in the SPD clean workroom. The SOC was observed providing service to the hospital's sterilizer. The SOC stated the sterilizer was not getting enough steam and a poor steam system would "definitely" affect the sterilization process and could cause sterilization failure.

A review of the hospital's P&P titled, "OR-Instrument Processing," revised March 2025, was conducted. The P&P indicated, "...Procedure...All instruments shall be carefully inspected for flaws, damage, debris, detergent residue, and completeness before drying..."

5. A concurrent observation and interview were conducted on April 1, 2025, at 11:20 a.m., with the DQIP, Lead SPDT 1, and the Environmental Service Technician (EVS 1) in the SPD clean workroom. Black and brown scattered spots were observed throughout the floor; peeling red tape was observed on the floor at the entrance of the clean workroom; medical device stickers, and black sticky substances were observed throughout the floor; black and brown spots were observed on the wall's baseboards; and thick grey matter was observed throughout the floor and on the wall's baseboards. Lead SPDT 1 stated the SPD workroom should have been terminally cleaned at the end of each day. EVS 1 stated she was not sure when the SPD workroom was terminally cleaned because the process occurred at night, and she didn't work the night shift. EVS 1 stated the medical stickers and black sticky substances would need to be "manually removed with a spatula type tool." EVS 1 stated the debris observed on the floor could potentially transfer onto the clean surgical instruments.

An interview and review of the facility's document titled, "Terminal Cleaning Log-Surgical Services," dated March 2025, was conducted with the EVS Supervisor (EVSS) on April 3, 2025, at 4:55 p.m., in the conference room. The terminal cleaning log indicated the SPD workroom was cleaned daily from March 1, 2025, to March 20, 2025. The EVSS stated the logs for March 21, 2025, to April 3, 2025, were missing and she could not explain why the logs were missing if the SPD workroom had been terminally cleaning after March 21, 2025. The EVSS stated the hospital recently made changes to the EVS department and the SPD workroom did not have a supervisor. The EVSS stated, "Additionally, a supervisor should have inspected the SPD workroom and signed off daily that terminal cleaning had been performed." The EVSS stated the hospital did not have a specific P&P for performing terminal cleaning in the SPD workroom.

A review of the AORN guidelines titled "Guidelines for Perioperative Practice: Environmental Cleaning," dated 2025, was conducted. The guidelines indicated, "...6. Sterile Processing Areas: 6. Sterile Processing Areas...6.2 Terminally clean sterile processing areas each day the areas are used..."

6. A review of Patient 13's record was conducted. A facility document titled, "History and Physical," dated February 26, 2025, showed Patient 13 was admitted to the hospital on February 26, 2025, with the diagnosis of abdominal pain (pain felt anywhere between the chest and the pelvis area).

An interview and review of Patient 13's "Authorization for and Consent to Surgery or Special Diagnostic or therapeutic Procedures," dated February 26, 2025, was conducted with the Manager of the Telemetry Unit (a specialized area where patients receive continuous remote electronic monitoring) and the Medical Surgical Unit (TMS Manager) on April 3, 2025, at 3:27 p.m., in the conference room. The surgical consent document showed the following:

1. Procedure to be Performed: Exploratory laparotomy repair gastrostomy tube possible bowel resection possible jejunostomy (a surgical procedure where the abdomen is opened to assess and address abdominal problems, including nutritional assess and bowel issues); and

2. Physician Certification: The consent form showed Physician 1's signature and did not indicate the time or date that the physician's certification process had been completed.

The TMS Manager stated nursing services should have ensured the consent form was completed prior to the procedure or the procedure should have been delayed until the surgical consent process had been completed and fully documented. The TMS Manager stated during the certification process the physician should have documented the date and time that he had certified the consent process. The TMS Manager stated the hospital did not follow the policy and procedures for obtaining a surgical consent and there was room for additional education related to the hospital's consent process.

A review of the hospital's P&P titled, "Medical Record Content &(and) Documentation," revised April 2, 2024, was conducted. The P&P indicated, "...III. Policy: F. All entries made in the record shall be legibly signed by the person making the entry, print name (optional), date, and time. The date and time shall be the date and time that the entry was made..."

A review of the hospital's P&P titled, "Consent Informed Consent," was conducted. The P&P indicated, "...C. Documenting Informed Consent: The doctor will complete the information in the "Consent to Surgery or Special Procedure" form or provide the information to the surgical scheduling office so the form can be completed...4. The patient's physician must document in the patient record that he or she has conveyed the information required for an informed decision, by signing the physician certification on the "Consent to Surgery and Special Procedure" form, except in cases of emergency surgery or the procedure may not proceed unless this certification is on record. The nursing staff shall be responsible for verifying this (consent process) has been included in the chart prior to the surgery and checking this off on the Surgical Checklist..."

7. An observation was conducted with the CNO and the DQIP on April 2, 2025, at 10:14 a.m., of the manual instrument cleaning (the physical removal of visible soil and debris from instruments using hand-held brushes, detergents, and water) process, in the SPD decontamination workroom. SPD Tech 1 was observed standing at the decontamination sink and brushing debris off the surface of the surgical instrument. SPD Tech 1 walked toward the SPD's clean supply stock, and was observed removing his soiled gloves, and placing the soiled gloves onto the transport cart. SPD Tech 1 was not observed to perform hand hygiene after he had removed his soiled gloves. SPD Tech 1 gathered the clean supplies and was observed walking back to the decontamination sink.

An interview was conducted with SPD Tech 1 on April 2, 2025, at 10:20 a.m., in the SPD decontamination workroom. SPD Tech 1 stated he was performing manual instrument cleaning, and he had needed a specialized hand-held brush to clean the inner portion of the instrument. SPD Tech 1 confirmed he did not perform hand hygiene after handling soiled instruments. SPD Tech 1 stated he should have performed hand hygiene after handling soiled instruments and removing his gloves. SPD Tech 1 stated he did not know why he placed the soiled gloves onto the transport cart instead of properly disposing the gloves into the "red bin" (a waste bin specifically used to dispose of items contaminated with blood or other potentially infectious materials).

A review of the hospital's P&P titled, "Hand Hygiene Program," revised June 2024, was conducted. The P&P indicated, "...11. A. Hand Hygiene: Hospital personnel will perform hand hygiene to prevent the spread of infections under the following conditions and circumstances...c. Before donning (the act of putting on) gloves and after doffing (taking off or removing) gloves...l. After handling blood, secretions, or excretions...D. Glove use...5. Discard gloves after each task and clean your hands-gloves may carry germs..."

8. A concurrent observation and interview were conducted with the DQIP and SPD Tech 1, on April 1, 2025, at 11:40 a.m., in the SPD decontamination workroom. The emergency eyewash station was observed attached above the decontamination sink. SPD Tech 1 confirmed the sink was used for decontaminating and cleaning potential infectious surgical instruments. SPD Tech 1 stated if he needed to use the emergency eyewash station and washed his eyes over the decontamination sink, potential infectious material could accidently splash into his eyes. The DQIP stated she was not aware that the emergency eye wash shoul