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Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.21 QAPI was out of compliance.

A-0286 PATIENT SAFETY: (a) Standard: Program Scope (1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will ... identify and reduce medical errors. (2) The hospital must measure, analyze, and track ...adverse patient events ... (c) Program Activities ..... (2) Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital. (e) Executive Responsibilities. The hospital's governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: ... (3) That clear expectations for safety are established. Based on interviews and document review, the facility's quality and performance improvement (QAPI) program failed to ensure two of three adverse events reviewed that occurred in the operating room (OR) were analyzed and preventative actions implemented. Additionally, the facility failed to report an occurrence in which an anesthesia provider diverted medications.

Based on interviews and document review, the facility's quality and performance improvement (QAPI) program failed to ensure two of three adverse events reviewed that occurred in the operating room (OR) were analyzed and preventative actions implemented. Additionally, the facility failed to report an occurrence in which an anesthesia provider diverted medications.

Facility findings:

Facility policies:

The Medication Diversion policy read the prevention of medication diversion is essential to ensure the protection of patients, employees, practitioners, and others. Diversion means diverting or otherwise misappropriating medication from the facility or from facility patients for uses that are illegal and/or not medically authorized or necessary (e.g., taking medications for the practitioner's own use). Compliance with the requirements of federal and state survey agencies is required. Additionally, facility review of diversion events does not preclude the facility from contacting federal and state authorities and filing appropriate reports.

The Facility Event/Notification Reporting, Requirements for Reporting to External Entities, Close Call Reporting policy defined an occurrence as an event, situation, or process that contributes to, or has the potential to contribute to patient injury or degrade the ability to provide optimal patient care. An adverse event is defined as any deviation from usual medical care that causes an injury to the patient or poses a risk of harm. Adverse events include errors, preventable adverse events, and hazards. An adverse event indicates an undesirable outcome resulting from some aspect of diagnosis or therapy and not the underlying disease process. The Risk Manager/Patient Safety Director will confirm appropriate review/investigation has been conducted and has resulted in accurate primary and specific cause selection. The Risk Manager/Patient Safety Director will ensure the event report has been referred to other managers for initial review and follow-up as appropriate. The Events Requiring Mandatory Reporting section of the policy read, all hospital departments and staff shall immediately report any reportable event. Risk Management will submit an initial report to the Colorado Department of Public Health and Environment (CDPHE) by the next business day after the occurrence or the day after the facility becomes aware of the occurrence. Risk Management will ensure Federal, State, and local requirements for event and close call reporting, review, and response are met.

The Serious Safety Event policy read the purpose of the policy is to provide direction on identification, notification, and management of patient serious safety events. A serious safety event is defined as a safety event (not primarily related to the natural course of the patient's illness or underlying condition) that reaches a patient and results in death, severe harm (regardless of duration of harm), or permanent harm (regardless of severity of harm). Serious safety events are a subcategory of adverse events. Patient serious safety events (SSE) are a subcategory of adverse events. Adverse events can also be considered patient SSEs if the outcome is not death, permanent harm, or severe temporary harm, but, the adverse event is indicative of serious process gaps that suggest the facility is at risk for future adverse events and SSEs. A safety event analysis (SEA) will be conducted on all serious safety events and the facility may choose to conduct a SEA for near miss/close call events and other unsafe conditions and events. All reporting requirements for mandatory or voluntary notifications of state and federal regulatory/accrediting agencies should be completed within the agencies' specified timeframes.

The Code Blue - Adult Patients (18 and Older) policy read the purpose of the policy is to provide standardized care and emergency response to adult patients. Individuals who participate in the Code are required to sign the Code Blue Record immediately following the completion of resuscitation efforts. Events of the Code Blue will be recorded on the Code Blue Record, including EKG strips. The original copy of the Code Blue Record will remain with the patient's chart as a part of the permanent record. Team Member Responsibilities: Code Record Documentation - A nurse responder will initiate documentation on the Code Blue record. Then the role will be assumed by the intensive care unit (ICU) charge or the ICU charge designee on arrival of the code blue team.

Facility plan:

The Quality, Performance Improvement and Risk Management Plan read, the overall objective is to provide and maintain a safe environment through the recognition of near misses and perceived safety events/errors and a venue for reporting, investigation, and improvement. Information from data analysis is used to make changes that improve performance, quality patient safety, and reduce the risk of adverse events. The plan defined an error as an unintended act, either of omission or commission, or an act that does not achieve its intended outcome. A sentinel event is defined as an unexpected occurrence involving death or serious physical or psychological injury or the risk thereof. A serious patient adverse event (SPAE) is any event within the control of a provider that results in harm and requires a new or modified physician order for the management of the patient's medical care. Triggers for intensive assessment, and potential change in priorities, may include the following: Significant variations from other organizations and recognized standards, adverse sedation/analgesia, and anesthesia events or patterns, results of resuscitation, sentinel events, and as part of an apparent cause analysis (ACA) or serious event analysis (SEA) for a sentinel event, regulatory defined events, or otherwise significant event, including near miss when indicated.

References:

The anesthesia providers' Professional Services Agreement read, the contractor and contractor's representatives shall comply with bylaws, rules and regulations, policies and directives of the facilities' medical staffs. The contractor shall support all of the facilities policies and procedures, including but not limited to the facilities policy relating to medication diversion.

The Board of Trustees (governing body) bylaws read, the Clinical Patient Safety & Quality Committee of the Board (CPSQC) is responsible for oversight of the assessment, preservation and improvement of the quality and efficiency of patient care that is provided in a safe environment within the Facilities, including oversight of activities related to quality management and performance improvement, risk management, utilization review, customer service and satisfaction, Medical Staff and advanced practice professional peer review and credentialing, institutional review committee, and regulatory compliance. CPSQC's responsibilities include: Use data to identify problems and opportunities, guide policy directives, and to monitor improvements and sustainability of improvements in patient safety and quality of care.

The Health Facilities and Emergency Medical Services Division (HFEMSD) Occurrence Reporting Manual, Occurrence Reporting Statute C.R.S. section 25-1-124(2) read, each health care facility licensed pursuant to section 25-3-101 or certified pursuant to section 25-1.5-103 (1)(a)(II) shall report to the department all of the following occurrences: (g) any occurrence in which drugs intended for use by patients or residents are diverted to use by other persons. If the diverted drugs are injectable, the healthcare facility shall also report the full name and date of birth of any individual who diverted the injectable drugs.

1. The facility failed to investigate and identify causative factors related to an adverse event that resulted in death. Additionally, the facility failed to investigate and implement preventative actions after being made aware an anesthesia provider diverted medications.

A. An adverse event occurred during Patient #3's surgical procedure.

i. Patient #3's medical record was reviewed and revealed on 9/21/23, an adverse event occurred during Patient #3's surgery which resulted in Patient #3's death.

a. The operative note entered on 9/25/23 by Surgeon #8 and the anesthesia note entered by Anesthesiologist #6 on 9/21/23 were reviewed and revealed the following:

On 9/21/23 Patient #3 had surgery to implant a photodynamic balloon (an implantable balloon filled with liquid monomer that hardens when exposed to a specific light) inside their left humerus (upper arm bone) to stabilize a pathologic fracture (fracture of a bone which was weakened by another disease).

Patient #3 was admitted for surgery at 8:59 a.m. on 9/21/23. According to the anesthesia record, at 11:26 a.m., Patient #3 was intubated (a plastic tube was inserted into the airway to maintain breathing during surgery), and at 11:42 a.m. the surgery began. Surgeon #8 surgically enlarged the center of Patient #3's left humeral bone, inserted the photodynamic balloon, and began filling the balloon with the liquid monomer.

At 12:04 p.m., while filling the photodynamic balloon with liquid monomer, the balloon ruptured and the liquid monomer leaked into the enlarged center of Patient #3's humeral bone. Patient #3 became hypotensive (low blood pressure) and hypocarbic (low level of carbon dioxide in the blood resulting from deep or rapid breathing). Anesthesiologist #6 then administered vasopressors (medication used to constrict blood vessels and increase blood pressure) and implemented a ventilator recruitment maneuver (increase in airway pressure during mechanical ventilation to open up the lungs and improve oxygenation) to stabilize Patient #3.

Between 12:05 p.m. and 12:30 p.m., while Anesthesiologist #6 stabilized Patient #3's hypotension and hypocarbia, Surgeon #8 decompressed the ruptured photodynamic balloon and irrigated Patient #3's left humeral canal with normal saline to remove the liquid monomer that had seeped into the canal when the balloon ruptured. Surgeon #8 then inserted a second photodynamic balloon into the humeral canal. Shortly after Surgeon #8 began filling the second photodynamic balloon with liquid monomer the second balloon ruptured causing the liquid monomer to again leak into Patient #3's humeral canal. After the second photodynamic balloon ruptured, Surgeon #8 removed the ruptured balloon and again irrigated Patient #3's left humeral canal with normal saline to remove as much of the liquid monomer as possible.

At 12:30 p.m., a code blue (alarm called when unexpected cardiac or respiratory arrest requires resuscitation) was called after Patient #3 became "progressively hypoxemic" (lack of oxygen in the blood, tissues, and organs). However, there was no evidence Patient #3's surgery was stopped when the code blue was initiated. According to the anesthesia record and the operative note, Patient #3's surgery ended at 12:49 p.m., 19 minutes after the code blue was initiated and after Surgeon #8 inserted a third photodynamic balloon into Patient #3's left humeral canal, filled the balloon with liquid monomer and cured the monomer.

Further review of the anesthesia record revealed, that after the code blue had been initiated, between 12:37 p.m. and 1:00 p.m., there was no evidence Patient #3's vital signs had been assessed and recorded.

According to the operative note, Patient #3 was transferred to the ICU in critical condition after Patient #3's pulmonary edema had progressed into acute respiratory distress syndrome (ARDS- a life-threatening lung injury that allows fluid to leak into the lungs) and Patient #3 required a transfer out to a facility equipped to perform extracorporeal membrane oxygenation (ECMO- a form of life support used to treat life-threatening illnesses or injuries that affect the functionality of the heart or lungs).

A review of the postcode blue note entered on 9/21/23 at 5:51 p.m., revealed while in the ICU a second code blue was initiated for Patient #3. Patient #3 became hypotensive and went into pulseless electrical activity (PEA) arrest (a non-shockable rhythm with loss of pulse). After repeated rounds of cardiopulmonary resuscitation (CPR) Patient #3 was unable to achieve a return of spontaneous circulation and Patient #3 expired at 5:49 p.m.

Upon request, the facility was unable to provide the code blue records for Patient #3.

This was in contrast to the Code Blue policy, which read, the care interventions, and activities provided during a Code Blue will be recorded on the Code Blue Record. Staff members who responded and participated in the Code Blue were required to sign the Code Blue Record immediately following the event. The Code Blue Record would be part of the patient's record.

ii. A review of the patient safety analysis and the procedural adverse event analysis provided by the facility for Patient #3's adverse event revealed the following:

a. On 9/25/23, staff present during Patient #3's code blue in the OR, nursing staff leadership, patient safety director (Director) #12, chief medical officer (CMO) #13, and the vice president of quality met to discuss the code blue event and perform a procedural adverse event analysis.

According to the patient safety analysis report investigation notes and the procedural adverse event analysis summary, facility processes for initiating a code blue were reviewed and no concerns related to the code blue were identified.

Further review of the procedural adverse event analysis summary revealed that Surgeon #8 had attempted to implant four photodynamic balloons, two of which were successfully implanted. According to the procedural adverse event analysis summary, Patient #3 became hypotensive and hypocarbic after Surgeon #8 completed Patient #3's surgery. However, this was in contrast to Surgeon #8's operative note and the events documented by Anesthesia #1 in the anesthesia record which revealed only three photodynamic balloons were implanted and the first two photodynamic balloons inserted into Patient #3's left humeral canal had ruptured and Patient #3 became hypotensive and hypocarbic requiring Anesthesiologist #6 to provide medical interventions to stabilize Patient #3.

Additionally, the code blue debrief and procedural adverse event analysis summary failed to identify vital signs had not been performed between 12:37 p.m. and 1:00 p.m. and that Surgeon #8 had continued the surgery for an additional 19 minutes after the code blue had been initiated.

b. On 2/14/24 at 9:04 a.m., an interview was conducted with Director #12. Director #12 stated they were responsible for reviewing all adverse safety events reported at the facility. Director #12 stated they ensured the adverse event review process was performed and when needed they initiated patient safety analysis and procedural adverse event analysis. Director #12 stated the purpose of a patient safety analysis and procedural adverse event analysis was to evaluate care interventions provided, get staff perspective of the events leading up to the adverse event, and identify if anything could have been done differently. Director #12 stated they had not identified any patient care concerns and or process issues during the debrief held on 9/25/23.

Director #12 reviewed the procedural adverse event analysis and Patient #3's medical record with surveyors during the interview. After both documents were reviewed with surveyors, Director #12 stated they had not identified there were no vital signs recorded for Patient #3 between 12:37 p.m. and 1:00 p.m. on 9/21/23. Director #12 also stated they had not identified Patient #3's surgical procedure had not ended when the code blue had been called and had continued for an additional 19 minutes.

Director #12 stated after they reviewed Patient #3's medical record and the procedural adverse event analysis with surveyors, they realized the care provided by Surgeon #8 and Anesthesiologist #6 needed to be further reviewed. Director #12 stated as the patient safety director they were not equipped to review and determine if the medical care provided to Patient #3 was appropriate or had contributed to the adverse event. Director #12 stated CMO #13 was responsible for determining when the medical care provided to patients required further review.

The code blue and procedural adverse event analysis sign in sheet was reviewed and revealed CMO #13 attended the debrief on 9/25/23, however, the facility was unable to provide evidence the medical care provided for Patient #3 had been reviewed.

c. On 2/16/24 at 10:01 a.m., an interview was conducted with Surgeon #8. Surgeon #8 stated on 9/21/23 Patient #3 decompensated quickly during the surgical procedure. Surgeon #8 stated they recalled Patient #3 required increased support needs and they had not been informed by Anesthesiologist #6 that Patient #3 had become critically unstable. Surgeon #8 further stated after Patient #3 had become unstable Anesthesiologist #6 had not relayed that Patient #3 was critical or that the surgery should have been stopped. However, Surgeon #8 stated Anestheologist #6 called two additional anesthesiologists into the OR to help stabilize Patient #3 prior to the activation of the code blue event. Surgeon #8 stated Patient #3's death was traumatic for all staff involved and the debrief on 9/25/23 allowed all staff to discuss the events leading up to Patient #3's death. Surgeon #8 further stated no issues or concerns had been identified upon review of Patient #3's care.

d. On 2/8/24 at 7:21 a.m., an interview was requested with Anestheologist #6. At 1:04 p.m., the director of quality (Director) #15 informed surveyors that anesthesiology services provided at the facility were provided by a third-party contractor. Director #15 further stated Anesthesiologist #6 and all anesthesiologists who worked for the third-party contractor refused to be interviewed by surveyors without legal counsel present.

B. Review of the occurrence log revealed on 1/20/24 an anesthesia provider injected themselves with medications in the OR.

i. A review of the Medication Diversion Team (MDT) 1/21/24 meeting minutes revealed, on 1/20/24, Anesthesiologist #1 was observed to inject intramuscular (IM) ondansetron (nausea medication) and ketorolac (anti-inflammatory pain medication) to themselves during a surgical case with Patient #7 on the operating room table. Anesthesiologist #1 was suspended pending an investigation and a urine drug screen was performed.

ii. A review of the Medical Executive Committee (MEC) meeting minutes from 1/29/24 revealed, on 1/21/24, Anesthesiologist #1 had been placed on a precautionary suspension. Anesthesiologist #1 was determined unable to exercise his clinical privileges based on the quality of care provided and patient safety concerns related to the diversion event which occurred on 1/20/24. MEC meeting minutes also revealed if Anesthesiologist #1 was not placed on a precautionary suspension it placed patients at imminent risk of harm.

Further review of the MEC meeting minutes revealed Anesthesiologist #1 relayed to the MEC that he had developed a horrible headache and nausea from temporomandibular dysfunction (TMJ- pain and dysfunction in the jaw joint and the muscles that control jaw movement) during Patient #7's surgery, which was why Anesthesiologist #1 injected the medications.

iii. The facility was unable to provide evidence Anesthesiologist #1 had been diagnosed with TMJ before the diversion event on 1/20/24.

iv. Review of pharmacist audits conducted for Anesthesiologist #1's January medication pulls from the medication dispensing machine (Pyxis) revealed audits were not performed for the medication ketorolac, which Anesthesiologist #1 had admitted to diverting, to confirm ketorolac was the actual medication injected.

v. Review of Anesthesiologist #1's urine drug screen results revealed the test was not performed until the next day, on 1/21/24, and was negative for all controlled substances.

vi. Review of the MEC meeting minutes from 1/29/24 further revealed Anesthesiologist #1's precautionary suspension was to be lifted on 1/30/24, 10 days after Anesthesiologist #1 had diverted medications. The MEC required Anesthesiologist #1 to schedule an intake and evaluation with the Colorado Physician Health Program (CPHP- a peer assistance program), which was to be completed within 60 days of his reinstatement. After Anesthesiologist #1 completed the CPHP intake and evaluation, and if CPHP made recommendations, the MEC would consider whether to require additional education, follow up with CPHP, or implement any other additional actions.

vii. On 2/22/24, upon request, the facility was unable to provide evidence Anesthesiologist #1 had registered or attended the required CPHP intake and evaluation to ensure they were safe to provide patient care before the suspension was lifted on 1/30/24. Additionally, the facility was unable to provide evidence of any preventative actions implemented after the diversion event occurred to prevent the recurrence of diversion in the OR.

This was in contrast to the Quality, Performance Improvement and Risk Management Plan which read, information from data analysis would be used to make changes that improved performance, quality, patient safety, and reduced the risk of adverse events.

viii. On 2/15/24 at 1:59 p.m., an interview was conducted with pharmacy director (Director) #2. Director #2 stated, on 1/20/24, Anesthesiologist #1 had access to medications that could have been metabolized and not shown up on the urine drug screen performed on 1/21/24, the day after the incident occurred. Director #2 stated an impaired practitioner could cause harm to patients.

ix. On 2/22/24 at 2:17 p.m., an additional interview was conducted with Director #2. Director #2 stated there was no way to audit Anesthesiologist #1's Pyxis medication pulls for medications which were not controlled substances, and audits had not been performed for ketorolac.

x. On 2/14/24 at 9:03 a.m., an interview was conducted with patient safety director (Director) #12. Director #12 stated the medical staff governed themselves and were separate from the quality department.

xi. On 2/22/24 at 1:43 p.m., an interview was conducted with the director of quality (Director) #15. Director #15 stated the MEC was responsible for the decision making process for the suspension and reinstatement of Anesthesiologist #1. Director #15 explained that the MEC's decisions were based on pharmaceutical audits conducted by Director #2, from interviewing Anesthesiologist #1, and from Anesthesiologist #1 not having a prior history with drug diversion. Director #15 then stated when a provider was given access to medications, there was not a 100% way to prevent drug diversion.

xii. On 2/20/24 at 12:16 p.m., an interview was conducted with Provider #3, a member of the MEC. Provider #3 stated the MEC was waiting to receive information from the contracted company Anesthesiologist #1 worked for and the CPHP evaluation before determining if additional actions would be implemented.

xiii. On 2/20/24 at 3:48 p.m., an interview was conducted with Provider #4, a member of CPSQC and the governing body. Provider #4 stated the governing body had ultimate responsibility for quality and patient safety, and was responsible for approving actions taken by the MEC. Provider #4 stated when a provider diverted medications, they should not have been reinstated until all investigations had been completed.

This was in contrast to the MEC meeting minutes which revealed Anesthesiologist #1's suspension was lifted prior to his intake and evaluation with CPHP, which was to be completed within 60 days of his reinstatement. This was also in contrast to the Interview with Provider #3 who revealed the MEC was still waiting for further information from Anesthesiologist #1's contracted company, however, Anesthesiologist #1 was reinstated prior to the receipt of the information.

2. The facility failed to ensure a drug diversion event was reported to the state agency as an occurrence.

a. Review of the Medication Diversion Team (MDT) meeting minutes for 1/21/24 revealed, on 1/20/24, Anesthesiologist #1 self-injected intramuscular (IM) medications obtained from the OR pyxis.

b. According to the occurrence log provided by the facility, the occurrence was reported on 1/20/24 and was closed on 1/22/24, after being reviewed by chief medical officer (CMO) #13. CMO #13 had not reported the medication diversion occurrence to the state at that time.

c. Review of the state agency's occurrence reporting database on 2/20/24, over a month after the medication diversion event was reported to the facility, revealed the facility had not reported the diversion occurrence.

This was in contrast to the HFEMSD Occurrence Reporting Manual, Occurrence Reporting Statute C.R.S. section 25-1-124(2)(g) which read, any event in which medications intended for patient use were diverted was to be reported to the state agency. Additionally, the facility must report the diversion of all injectable medications.

d. On 2/20/24 at 11:08 a.m., an interview was conducted with the Director #12. Director #12 stated they were responsible for reporting occurrences to the state agency. Director #12 stated they had not reported the diversion event involving Anesthesiologist #1 to the state agency. Additionally, Director #12 asked surveyors which state reportable occurrence event would the adverse event involving Anesthesiologist #1 be reported under.

e. On 2/20/24 at 4:57 p.m., during a discussion with facility leadership and CMO #13, CMO #13 stated the medication diversion event with Anesthesiologist #1 was not reported as a state reportable event per the recommendation of their attorney.

These interviews were in contrast to the Facility Event/Notification Reporting, Requirements for Reporting to External Entities, Close Call Reporting policy which read, Risk Management would submit an initial report to the Colorado Department of Public Health and Environment (CDPHE) by the next business day after the occurrence, or the day after the facility became aware of the occurrence. Risk Management would ensure state requirements for event reporting had been met.

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §416.51 INFECTION CONTROL was out of compliance.

A-0749 (a)(2) The hospital infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the hospital and between the hospital and other institutions and settings. Based on observations, document reviews, and interviews, the facility failed to ensure a functional and sanitary environment for surgical services to avoid sources and transmission of infections and communicable diseases. Specifically, the facility failed to ensure surgical instruments were processed in accordance with the facility policies and manufacturer instructions for use (IFU) in two out of two observations in the sterile processing department (SPD).

Based on observations, document reviews, and interviews, the facility failed to ensure a functional and sanitary environment for surgical services to avoid sources and transmission of infections and communicable diseases. Specifically, the facility failed to ensure surgical instruments were processed in accordance with the facility policies and manufacturer instructions for use (IFU) in two out of two observations in the sterile processing department (SPD).

Findings include:

Facility policy:

The Sterile Processing Procedures read, one of the measures for preventing surgical site infections is to provide surgical items that are free of contamination at the time of use. This can be accomplished by subjecting them to cleaning and decontamination, followed by a sterilization process. A manufacturer instruction database (OneSource) will be accessible and utilized by staff to reference handling, cleaning, sterile processing and storage of all devices. All objects to be sterilized must first be thoroughly cleaned to remove all bio-burden and other residue. Manual cleaning with approved detergent and clean brushes will occur to remove gross soil from items. All items will be cleaned while submersed in water to prevent contaminated fluids from becoming aerosolized. Any instrument or equipment with moving parts must be disassembled for proper cleaning. All lumens must be cleaned with an appropriate sized brush and flushed with enzymatic.

References:

According to the Association of periOperative Registered Nurses (AORN) (2012-2023), Guidelines for Perioperative Practice: Instrument Cleaning, failure to clean, inspect, disinfect or sterilize an item may lead to transmission of pathogenic microorganism from a contaminated device and create risk for patient injury, including surgical site infection.

According to the Association for the Advancement of Medical Instrumentation (AAMI) Sterile Processing - Knowledge, Skills, Competencies, provided by the facility, cleaning is the most important step in sterile processing; thorough cleaning removes most microorganisms and other organic material from contaminated items. Unless an item is clean, it cannot be effectively disinfected or sterilized. Any soil, no matter how little, can prevent disinfectant or sterilant from contacting the surface of an item. We can assess visible contamination by examining items carefully, but microorganisms are invisible so we consider items contaminated even when we cannot see any soil. The best resource for determining how best to manage an item is the manufacturer's IFU.

The BD MEDICAL / CAREFUSION / V. MUELLER General Surgical Instrument Cleaning and Prevaccuum Sterilization IFU read, all devices must be processed in the completely open position (I.e. flushports, jaws, etc.) to allow solution contact of all surfaces. Place the device in the open/relaxed position with the flush port open. Completely Immerse the device in the detergent solution and allow it to soak for a minimum of five minutes. Actuate all movable parts during the initiation of the soak time. Using a soft bristled brush, remove all visible soil from the device. Actuate the device while brushing, paying particular attention to hinges, crevices and other difficult to clean areas. For lumen devices, use a soft bristled brush with a brush diameter and length that is equivalent to lumen diameter and length. Scrub the lumen until no visible soil is detected in the lumen. Place the device into the open/ relaxed position with the distal tip pointed down. Flush the device with a minimum of 50 ml of detergent solution. Rinse the device by completely immersing it in treated water for a minimum of 30 seconds to remove any residual detergent or debris. For lumen devices, place the device into the open/relaxed position with the distal tip pointed down. Flush the device with a minimum of 50 ml by using the flushing port located on the handle/shaft. Repeat the flush process a minimum of two (2) times (i.e. total of three (3) times).

The Symmetry Surgical Recommended Care, Cleaning and Sterilization Instructions for Reusable Instruments & Accessories IFU read, completely submerge instruments in the enzyme solution and gently shake them to remove trapped bubbles. Actuate instruments with hinges or moving parts to ensure contact of the solution with all surfaces. Lumens, blind holes and cannulas should be flushed with a syringe to remove bubbles and ensure contact of the solution with all instrument surfaces. Soak instruments for a minimum of 10 minutes. While soaking scrub surfaces using a soft nylon-bristled brush until all visible soil has been removed. Actuate moveable mechanisms. Particular attention should be given to crevices, hinged joints, box locks, instrument teeth, rough surfaces and areas with moving components or springs. Lumens, blind holes and cannulas should be cleaned using a snug fitting round nylon bristle brush. All scrubbing should be performed below the surface of the enzyme solution to minimize the potential of aerosolizing contaminated solution.

The STRYKER ENDOSCOPY StrykeFlow Suction IFU read, prepare a non-enzymatic detergent, according to the manufacturer's recommendations at 35°C. Fully immerse the device and inject the lumen and any mated surfaces and crevices with at least 50 mL of the detergent. Soak the device for 15 minutes.

TELEFLEX MEDICAL / PILLING / KMEDIC Metal Reusable General Surgical Instruments IFU read, place the instrument in an ultrasound bath at 104°F (40°C) with a 0.5% enzymatic detergent for 10 minutes (minimum). Remove the instrument and flush with lukewarm tap water for approximately 15 seconds while simultaneously brushing with a soft-bristled brush.

The da Vinci Xi ACCESSORIES Reprocessing Instructions read, brush submerged or under running water. Brush the entire device thoroughly with a nylon brush for at least 60 seconds under running cold water.

1. The facility failed to ensure surgical instruments were cleaned and processed in accordance with the facility policies and manufacturer's IFU. Specifically, the facility failed to manually clean and soak all surgical instruments in an enzymatic detergent prior to sterilization.

A. Observations

i. On 2/13/24 at 12:10 p.m., observations were conducted in the SPD. Observations revealed surgical instruments from the liver transplant tray being processed and cleaned by sterile processing technician (Tech) #7. Tech #7 observed placing hinged surgical instruments in a closed position into the surgical sink filled with neutral detergent solution. At 12:11 p.m., one minute after the surgical instruments were placed in the sink, Tech #8 removed the surgical instruments from the neutral detergent solution, brushed the tips of the instruments above the water line, missed the hinges and crevices, and placed the instruments in a nearby empty sink to be rinsed.

Further observation revealed Tech #7 manually cleaned a suction tip poole (suction instruments used to evacuate pooled blood, fluid, and debris). Tech #7 flushed the lumen of the instrument with 10 milliliter (ml) of neutral detergent solution, wiped the outside surface with a sponge, did not brush the internal lumen, and placed the instruments in a nearby empty sink to be rinsed. Tech #7 rinsed the instrument with running water and did not flush the internal lumen with rinse water.

Further observation revealed Tech #7 manually cleaning a blunt heparin needle (a needle to access small blood vessels for probing or injecting solutions). Tech #7 placed the needle in the neutral detergent solution to soak without being manually cleaned. Tech #7 removed the needle from the neutral detergent solution and placed it on the side of the sink. The needle was not brushed or flushed throughout the observation. Tech #7 placed the instrument in the surgical casket and placed the casket on a nearby rack while waiting for it to be placed in the automatic washing machine. Observations did not reveal the use of the ultrasonic bath.

Overall observations revealed 50 out of 60 instruments from the liver transplant tray were not processed in accordance with the facility policies and the manufacturer's IFU.

ii. On 2/13/24 at 12:32 p.m., observations were conducted in the SPD. Observations revealed surgical instruments from the Davinci Accessory Set being processed and cleaned by Tech #7. Tech #7 was observed placing hinged surgical instruments in a closed position into the surgical sink filled with neutral detergent solution. At 12:35 p.m., three minutes after the surgical instruments were placed in the sink, Tech #8 removed the surgical instruments from the neutral detergent solution, brushed the tips of the instruments above the water line, missed the hinges and crevices, and placed the instruments in a nearby empty sink to be rinsed.

Further observation revealed Tech #7 manually cleaning a STRYKER laparoscopic suction cannula (a suction instrument used to evacuate pooled blood, fluid, and debris). Tech #7 was observed flushing the lumen of the instrument with 15 ml of neutral detergent solution, wiped the outside surface with a sponge without brushing the internal lumen, and placed the instrument in a nearby empty sink to be rinsed. Tech #7 rinsed the instrument with running water and did not flush the internal lumen with rinse water.

Further observation revealed Tech #7 manually cleaning eight Intuitive surgical cannulas (an instrument used in endoscopic surgery to provide a point of entry for robotic and laparoscopic instruments). Tech #7 wiped the external surfaces of the cannula with a sponge and placed the instruments in a nearby empty sink to be rinsed. Tech #7 was not observed brushing the inner cannula. Tech #7 briefly rinsed the instrument with running water and placed the instrument in the surgical casket and placed the casket on a nearby rack.

Overall observations revealed 52 out of 74 instruments from the Davinci Accessory Set were not processed in accordance with the facility policies and the manufacturer's IFU.

iii. The observations conducted on 2/13/24 revealed surgical instruments were processed incorrectly per the facility's policy and manufacturer's IFU. Examples included:

Observations on 2/13/24 were in contrast to the Sterile Processing Procedure policy which read, all objects to be sterilized must first be thoroughly cleaned to remove all bio-burden and other residue. Manual cleaning with approved detergent and clean brushes will occur to remove gross soil from items. All items will be cleaned while submersed in water to prevent contaminated fluids from becoming aerosolized. Any instrument or equipment with moving parts must be disassembled for proper cleaning. All lumens must be cleaned with an appropriate sized brush and flushed with enzymatic.

Observations on 2/13/24 were in contrast to the Sterile Processing Procedures which read,all objects to be sterilized were to have been thoroughly cleaned to remove all bio-burden and other residue. Instruments were to have been manually cleaned with approved detergent and clean brushes to remove gross soil from items. All items were to have been cleaned while submersed in water to prevent contaminated fluids from becoming aerosolized. All lumens should have been cleaned with an appropriate sized brush and flushed with enzymatic.

Observations on 2/13/24 were in contrast to the BD MEDICAL / CAREFUSION / V. MUELLER General Surgical Instrument Cleaning and Prevacuum Sterilization IFU which read, all devices should be processed in the open position to allow solution contact of all surfaces. All devices should be completely immersed in the detergent solution and allowed to soak for a minimum of five minutes. All movable parts were to be actuated during the initiation of the soak time. A soft bristled brush was to be used to remove all visible soil from the device. The device was to be actuated while hinges were brushed, and crevices and other difficult areas cleaned. The lumen of the device was to be scrubbed with a soft bristled brush until no visible soil was detected in the lumen. The device was to be flushed with a minimum of 50 ml of detergent solution and a minimum of 50 ml of water a minimum of three times.

Observations on 2/13/24 were in contrast to the TELEFLEX MEDICAL / PILLING / KMEDIC Metal Reusable General Surgical Instruments IFU which instructed to place the instrument in an ultrasound bath at 104°F (40°C) with a 0.5% enzymatic detergent for 10 minutes (minimum). Remove the instrument and flush with lukewarm tap water for approximately 15 seconds while simultaneously brushing with a soft-bristled brush.

Observations on 2/13/24 were in contrast to the STRYKER ENDOSCOPY StrykeFlow Suction IFU which instructed to fully immerse the device and inject the lumen and any mated surfaces and crevices with at least 50 mL of the detergent. The device was to soak for 15 minutes.

iv. Due to the extent and nature of the findings from the observations performed on 2/13/24, an immediate jeopardy was declared on 2/14/24 at 4:35 p.m. An approved immediate jeopardy abatement plan was provided by the facility on 2/15/24. According to the abatement plan, education was provided by sterile processing manager (Manager) #9 to the SPD staff and administration, all SPD received an online learning module, and all instruments were reprocessed according to the IFUs before surgical procedures scheduled for the following day.

v. On 2/20/24 at 11:29 a.m., after the abatement plan was implemented, additional observations were conducted in the SPD. Observations revealed surgical instruments from the Basic Ortho Set A being processed and cleaned by sterile processing technician (Tech) #10. Tech #10 placed surgical instruments in an empty sink and sprayed the instruments with tap water. At 11:32 a.m., Tech #10 was observed placing surgical instruments into the surgical sink filled with neutral detergent solution. Further observation revealed a pair of surgical pliers in the closed position. At 11:35 a.m., three minutes after the surgical instruments were placed in the sink, Tech #10 removed the surgical instruments from the neutral detergent solution, visually inspected the instruments, did not manually clean the instruments, and placed the instruments in a nearby empty sink to be rinsed.. SPD Supervisor (Supervisor) #11 asked Tech #10 how long the instruments should soak, Tech #10 stated he did not know for sure, but he thought the soak time was two to three minutes. Supervisor #11 asked what time the instruments were placed in the neutral detergent solution, Tech #10 stated they did not know. The surgical instruments IFU were not verified and the instruments continued through the sterilization process.

Overall observation revealed 82 out of 82 instruments from the Basic Ortho Set A were not processed in accordance with the facility policies and the manufacturer's IFU.

The observations conducted on 2/20/24 revealed surgical instruments were processed incorrectly per the facility's policy and manufacturer's IFU. Examples included:

The Sterile Processing Procedures read, a manufacturer instruction database (OneSource) was accessible and utilized by staff to be referenced on how to handle, clean, sterile process and storage of all devices. All objects to be sterilized were to have been thoroughly cleaned to remove all bio-burden and other residue. Instruments were to have been manually cleaned with approved detergent and clean brushes to remove gross soil from items. All items were to have been cleaned while submersed in water to prevent contaminated fluids from becoming aerosolized.

Observations on 2/20/24 were in contrast to the BD MEDICAL / CAREFUSION / V. MUELLER General Surgical Instrument Cleaning and Prevacuum Sterilization IFU which read, all devices should be processed in the open position to allow solution contact of all surfaces. All devices should be completely immersed in the detergent solution and allowed to soak for a minimum of five minutes. All movable parts were to be actuated during the initiation of the soak time. A soft bristled brush was to be used to remove all visible soil from the device. The device was to be actuated while hinges were brushed, and crevices and other difficult areas cleaned.

B. Interviews

i. On 2/13/24 at 12:48 p.m., an interview was conducted with Tech #7. Tech #7 stated all surgical instruments were to have been manually washed after the procedure to remove any bioburden (organic material from a prior procedure). Tech #7 stated all surgical instruments with a lumen were expected to be flushed with 10 to 20 mls of neutral detergent solution and water. Tech #7 stated all of the instruments located in the surgical instrument casket were considered contaminated and were to have been manually cleaned and processed. Tech #7 stated when surgical instruments were not correctly manually cleaned after the procedure, the instruments could have been contaminated with bioburden and potentially caused a surgical infection.

This interview was in contrast to multiple observations of the SPD from 2/13/24 to 2/20/24 which revealed IFUs were not followed.

This interview was in contrast to the BD MEDICAL / CAREFUSION / V. MUELLER General Surgical Instrument Cleaning and Prevacuum Sterilization IFU which read the devices were to have been flushed with a minimum of 50 ml of detergent solution. Then the devices were to have been flushed with a minimum of 50 ml of water a minimum of three times.

ii. On 2/20/24 at 12:10 p.m., an interview was conducted with Tech #10. Tech #10 stated each surgical instrument had an IFU on how to clean and process the instrument properly. Tech #10 stated they should have allowed the surgical instruments to soak in a neutral detergent solution, visually inspect the instruments for bioburden, and spray the instruments off with running water. Tech #10 stated that they should have soaked instruments for three minutes; however, they stated they were unsure that was correct. Tech #10 stated that it was important to allow the instrument to soak for the appropriate amount of time to allow the bioburden to break down and be removed from the instruments.

Tech #10 stated it was important to follow the manufacturer's IFU to ensure all of the surgical instruments were processed properly. Tech #10 stated that when instruments were not cleaned correctly, there could have been bioburden left behind, and the instruments would not be sterilized after the steam sterilization cycle. Tech #10 stated surgical instruments not processed correctly could cause a surgical infection, leading to serious injury or even death.

This interview was in contrast to multiple observations of the SPD from 2/13/24 to 2/20/24 which revealed IFUs were not followed.

This was in contrast to the BD MEDICAL / CAREFUSION / V. MUELLER General Surgical Instrument Cleaning and Prevacuum Sterilization IFU which read, completely immerse the device in the detergent solution and allow it to soak for a minimum of five minutes. Actuate all movable parts during the initiation of the soak time. Using a soft bristled brush, remove all visible soil from the device. Actuate the device while brushing, paying particular attention to hinges, crevices and other difficult to clean areas.

iii. On 2/14/24 at 1:21 p.m., an interview was conducted with the manager of sterile processing (Manager) #8. Manager #8 stated they have been in their position for two months and during that time the infection prevention team did not perform audits in the sterile processing department.

Manager #8 stated the facility processed surgical instruments owned by the facility as well as instruments brought in by vendors. Manager #8 stated they processed the vendor instruments the same unless the vendor supplied an IFU. Manager #8 stated they were unsure on how to account for the variations in the IFUs for the surgical instruments that were processed in the same tray. Manager #8 stated the facility always followed the main standard of cleaning instruments unless there was a variance, and they had not seen variances in the IFUs often.

This was in contrast to multiple instrument IFUs reviewed from 2/13/24 to 2/20/24 which revealed multiple variations in the cleaning process that were not followed.

iv. On 2/20/24 at 4:56 p.m., a discussion was conducted with the facilities leadership team. Manager #10 stated it was standard practice to use a barrier to separate instruments that were used in the case from those that were not. Manager #10 stated that instruments not used in the surgical case would not have had to be manually cleaned. Assistant vice president of infection prevention (VP) #14 stated the facility followed AAMI guidelines and all surgical instruments were to have been reprocessed the same way as they were used in the surgical case.

Manager #10's statement was in contrast to the immediate jeopardy abatement plan that was provided by the facility on 2/15/24. According to the abatement plan, Manager #9 educated the SPD staff that all instruments were to be manually cleaned in addition to being visually inspected.

Manager #10's statement was also in contrast to the AAMI guidelines which read, unless an item was clean, it could not be effectively disinfected or sterilized. Visible contamination could be assessed by examining items carefully, but microorganisms were invisible, so items were considered contaminated even when no soil was visible.

Manager #10's statement was also in contrast to the Sterile Processing Procedures which read, all objects to be sterilized were to have been thoroughly cleaned to remove all bio-burden and other residue. Instruments were to have been manually cleaned with approved detergent and clean brushes to remove gross soil from items.