HCA Healthone Presbyterian St. Lukes

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 47959 Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.13 PATIENT RIGHTS was out of compliance. A-0144 PATIENT RIGHTS: CARE IN SAFE SETTING The patient has the right to receive care in a safe setting. Based on interviews and document review, the facility failed to ensure patients received care in a safe setting. Specifically, the facility failed to ensure the safety of a surgical patient with a transplanted organ who suffered adverse outcomes and ultimately expired. (Patient #4)”

“QAPI CFR(s): 482.21 The hospital must develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital’s governing body must ensure that the program reflects the complexity of the hospital’s organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. This Condition is not met as evidenced by: 47959 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 CONDITION was out of compliance. A-0283 QUALITY IMPROVEMENT ACTIVITIES (b) Program Data (2) [The hospital must use the data collected to (ii) Identify opportunities for improvement and changes that will lead to improvement. (c) Program Activities (1) The hospital must set priorities for its performance improvement activities that (i) Focus on high-risk, high-volume, or problem-prone areas; (ii) Consider the incidence, prevalence, and severity of problems in those areas; and (iii) Affect health outcomes, patient safety, and quality of care. (3) The hospital must take actions aimed at performance improvement and, after implementing those actions, the hospital must measure its success, and track performance to ensure that improvements are sustained. Based on interviews and document review, the facility failed to ensure the quality assessment and performance improvement (QAPI) program identified and implemented performance improvement activities that impacted surgical patients in the operating room (OR). (Patients #4 and #5)”

“SURGICAL SERVICES CFR(s): 482.51 If the hospital provides surgical services, the services must be well organized and provided in accordance with acceptable standards of practice. If outpatient surgical services are offered the services must be consistent in quality with inpatient care in accordance with the complexity of services offered. This Condition is not met as evidenced by: 47962 Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.51 Surgical Services was out of compliance. A-0955 INFORMED CONSENT A properly executed informed consent form for the operation must be in the patient’s chart before surgery, except in emergencies. Based on observations, interviews, and document review, the facility failed to ensure procedural consents for surgery included the names of all participating surgical practitioners. This failure impacted four of four pediatric surgical patients’ medical records reviewed. (Patients #5, #7-9) A-0959 OPERATIVE REPORT An operative report describing techniques, findings, and tissues removed or altered must be written or dictated immediately following surgery and signed by the surgeon. Based on interviews and document review, the facility failed to ensure operative reports were complete and accurate. This failure impacted one of four pediatric surgical patients’ medical records reviewed. (Patients #5)”

“PATIENT RIGHTS: CARE IN SAFE SETTING CFR(s): 482.13(c)(2) The patient has the right to receive care in a safe setting. This Standard is not met as evidenced by: 47959 Based on interviews and document review, the facility failed to ensure patients received care in a safe setting. Specifically, the facility failed to ensure the safety of a surgical patient with a transplanted organ who suffered adverse outcomes and ultimately expired. (Patient #4) (Cross-reference A-0283) Findings include: Facility policy: According to the Patient Rights and Responsibilities policy, patients have the right to receive high-quality, safe,and professional care. Reference: According to the Association of periOperative Registered Nurses (AORN) Position Statement on Patient Safety, severe, preventable injury and harm should never occur in the perioperative practice setting. Every patient has the right to receive the highest quality perioperative care in every practice setting where operative and other invasive procedures are performed. Health care providers must collaborate on interdisciplinary teams to establish and sustain an organizational culture of patient safety by developing initiatives aimed at reducing errors, engaging patients to participate in their own care and creating an environment that is safe for patients. (2022; retrieved from https://www.aorn.org/docs/default-source/guidelines-resources/position-statements/patient-workplace-safety/posstat-pt-safety-0303.pdf?sfvrsn=546e0db0_1) 1. The facility failed to ensure abdominal surgical patients with a transplanted organ history received safe care in a surgical procedure. A. Medical record review i. Medical record review revealed Patient #4 was admitted to the facility on 10/15/24 for a ventral hernia (an intestine pushed through a weakness in the abdominal wall) repair and removal of both native (original) polycystic kidneys (a disorder that causes fluid-filled cysts to grow in the kidneys). Medical record review revealed Patient #4 had undergone a kidney transplant in 2001 and it was necessary to remove the patient’s native polycystic kidneys to make space in the abdominal cavity for the intestines. Medical record review revealed the transplanted kidney had adhered to the native polycystic kidney which resulted in the accidental removal of the transplanted kidney when urology surgeon (Provider) #5 removed Patient #4’s polycystic kidney. During an interview on 11/5/24 at 8:22 a.m., Provider #5 stated they had made an extensive plan, which they had reviewed daily for a week, in preparation for Patient #4’s nephrectomy (removal of kidneys) to make room for the intestines which hung to Patient #4’s mid-thighs. Provider #5 stated they reviewed the radiology images the day before Patient #4’s surgery and saw the transplanted kidney adhered to the polycystic kidney. Provider #5 stated they formulated a plan to remove the polycystic kidneys. They stated when the bowels were temporarily moved from Patient #4’s body (and gathered into a bag), the abdominal organs shifted in position, which altered the surgical landscape. Provider #5 stated they were not able to follow their previous surgical plan and did not recognize the transplanted kidney due to the repositioning of the organs and the patient’s unique anatomy. Provider #5 stated they were unsure of what could have been changed to keep the patient safe during this surgical procedure. They stated prior to the surgery, a transplant surgeon (Provider #6) informed them that because the transplant had happened in 2001 (23 years before), Patient #4’s case would not have warranted a transplant surgeon to be consulted or in the room. This statement was in contrast to an interview on 10/31/24 at 2:36 p.m. with transplant surgeon (Provider) #6 who stated with the unique anatomy of Patient #4 (who had a kidney transplant, polycystic kidneys, and a large ventral hernia), they would have started with an examination of the vascular structure and worked their way along the vena cava to correctly identify landmarks. Provider #6 also stated neither Provider #5 nor themselves had recent experience removing polycystic kidneys. In addition to this complication, the medical record review also revealed Patient #4’s vena cava (a large vein that carries blood back to the heart) tore during the procedure which caused a hemorrhage (a rapid loss of a large amount of blood). Staff in the operating room (OR) called Provider #6 to assist with the complications. However, there was no evidence in the medical record that Provider #6 was contacted prior to the mistaken removal of the transplanted kidney and excessive bleeding with Patient #4. The surgical team stopped the bleeding and transferred Patient #4 to the intensive care unit (ICU) post operatively. ICU doctor (Provider) #7 placed a dialysis catheter (a flexible tube inserted into a vein to clean the blood of waste and excess fluid in the absence of kidneys) at the bedside for Patient #4’s future need of dialysis. Additional medical record review revealed Patient #4 experienced further complications and returned to the OR to repair the vena cava and remove a blood clot from the right leg. Patient #4 returned back to the ICU following the procedure. Medical record review revealed staff monitored Patient #4 for complications and on 10/17/24, staff determined the dialysis catheter had stopped working and Provider #7 changed out the wire on the dialysis catheter. Medical record review revealed Patient #4 talked to Provider #7 during the procedure and at the conclusion of the procedure, suddenly lost consciousness and Provider #7 noticed a large amount of blood from Patient #4’s abdominal incision. Provider #7 called a code (an emergency code to indicate cardiac or respiratory arrest). Medical record review revealed the team performed cardiopulmonary resuscitation (CPR) (an emergency treatment to manually keep the heart beating) on Patient #4, however, Patient #4 expired approximately one hour later. B. Interviews i. On 11/4/24 at 4:08 p.m., an interview was conducted with Provider #10, the general surgeon who assisted with Patient #4’s procedure. Provider #10 stated they relied on the expertise of Provider #5 to remove Patient #4’s polycystic kidneys. Provider #10 stated they consulted Provider #5 to identify the polycystic and transplanted kidneys. Provider #10 stated Provider #5 should have identified the transplanted kidney before they removed the polycystic kidney. ii. On 10/31/24 at 2:36 p.m., an interview was conducted with the transplant surgeon, Provider #6. Provider #6 stated staff consulted them on an emergency situation for Patient #4. Provider #6 stated Patient #4 was a complicated case and they would have taken a different approach to reach the transplanted kidney. Provider #6 stated they would have started with a more careful examination of the transplant vascular structure and then worked their way up along the vena cava to identify landmarks. Provider #6 stated they had not done a polycystic kidney case in seven or eight years and did not know when Provider #5 performed their last polycystic kidney case. Provider #6 stated they wondered if either of them was the correct provider to do the case for Patient #4. Provider #6 also stated there could never have been too much help for assistance with complex cases. iii. On 10/31/24, an interview was conducted with registered nurse (RN) #11, who assisted with Patient #4’s procedure. RN #11 stated Provider #5 removed the polycystic kidney and announced they had accidentally removed the transplanted kidney and requested staff place the kidney on ice to help preserve it. RN #11 stated the patient hemorrhaged so staff implemented the massive transfusion protocol (a protocol used to infuse a large amount of blood products during an emergency). RN #11 stated they called Provider #6 emergently. RN #11 stated after they participated in the facility’s review of the case, they had concerns the surgical case did not have a transplant surgeon consulted and present in the case. RN #11 stated a transplant surgeon had more experience and knowledge of the complications of polycystic kidneys and should have supported the urologist. iv. On 10/30/24 at 4:12 p.m., an interview was conducted with vice president of quality (VP) #8. VP #8 stated the facility completed a full investigation of Patient #4’s serious event. VP #8 stated they concluded from a system and process standpoint that all went according to plan and the event was a surgical error. VP #8 stated the facility did not suspend Provider #5 during the investigation. VP #8 further stated the facility implemented the process of requiring a transplant surgeon consultation for patients with a history of kidney transplants. VP #8 stated the transplant surgeon would make the decision of whether or not to be present for the surgical procedure. VP #8’s explanation of their new process of implementing only a consult with the transplant surgeon failed to acknowledge the failure with Patient #4’s procedure occurred within the operating room when their anatomy unexpectedly changed. The facility’s response fell short of keeping all patients safe within the operating room and was in contrast to the Patient Rights and Responsibility policy which read, patients have the right to receive high-quality, safe, and professional care. Furthermore, it was in contrast to the AORN position statement on patient safety which read, severe, preventable injury and harm should never occur in the perioperative practice setting. Health care providers must collaborate on interdisciplinary teams to establish and sustain an organizational culture of patient safety by developing initiatives aimed at reducing errors, engaging patients to participate in their own care and creating an environment that is safe for patients.”

“QUALITY IMPROVEMENT ACTIVITIES CFR(s): 482.21(b)(2)(ii), (c)(1), (c)(3) (b) Program Data (2) [The hospital must use the data collected to - .....] (ii) Identify opportunities for improvement and changes that will lead to improvement. (c) Program Activities (1) The hospital must set priorities for its performance improvement activities that-- (i) Focus on high-risk, high-volume, or problem-prone areas; (ii) Consider the incidence, prevalence, and severity of problems in those areas; and (iii) Affect health outcomes, patient safety, and quality of care. (3) The hospital must take actions aimed at performance improvement and, after implementing those actions, the hospital must measure its success, and track performance to ensure that improvements are sustained. This Standard is not met as evidenced by: 47959 Based on interviews and document review, the facility failed to ensure the quality assessment and performance improvement (QAPI) program identified and implemented performance improvement activities that impacted surgical patients in the operating room (OR). (Patients #4 and #5) (Cross-reference A-0144, A-0959 and A-0955) Findings include: Facility policies: According to the facility Quality Plan, the plan was used as a guide to plan, design, measure, assess, and improve organizational performance, identify and prevent organizational risk, and ensure the delivery of safe patient care. Facility leadership, medical staff, and the Board of Trustees ensured a culture that prioritized safety for patients and developed processes to reduce the risk of harm, sentinel events, adverse outcomes, and errors. According to the Serious Safety Event policy, the policy provided direction to identify and understand the factors that contributed to the event and improve the facility’s culture, systems, and processes with the intent to prevent recurrences and improve safety systems. An efficient and effective event analysis considers assessing whether or not a different person could have made the same error under similar circumstances by identifying and understanding the factors that contributed to the event and recognizing human error is not an acceptable root cause. The event analysis should improve the facility’s culture, systems, and processes with the intent to prevent recurrence and improve safety systems. 1. The facility failed to identify opportunities for improvement and implement actions to improve patient safety. A. Document review i. A review of the occurrences revealed on 10/15/24, urology (a medical specialty that treats the urinary system) surgeon (Provider) #5 accidentally removed Patient #4’s transplanted kidney when they removed the polycystic kidney (a genetic disorder that causes fluid-filled cysts to grow in the kidneys). Quality assurance staff performed a serious event analysis (SEA) and determined surgeons would consult transplant surgeons for patients with a transplant history prior to the procedure. (Cross-reference A-0144) ii. A review of the occurrences revealed on 8/8/24, Provider #2 performed surgery on Patient #5 without Surgeon #1 present but, with Surgeon #1’s permission. In the occurrence follow-up, staff documented Surgeon #1 made the incision, inserted the scope (camera), and let Provider #2 take over the scope. Quality assurance staff documented Surgeon #1 had left the operating room (OR) during the surgical procedure. The facility identified that Provider #2 had the necessary credentials to perform this type of surgery however, requested Surgeon #1 to be present in surgeries moving forward. From the medical records and interviews, Surgeon #1 left the OR quite often. The facility failed to identify that patients and their families had not consented to Provider #2 operating on them, especially with Surgeon #1 absent from the OR. Additionally, the operative note did not accurately reflect the care provided to the patient and by whom. (Cross-reference A-0959 and A-0955) The follow-up to the occurrence failed to identify concerns with informed consent and the quality and content of perioperative documentation. This was in contrast to interviews conducted on 11/5/24 with the director of quality (Director) #4 who stated accurate documentation was important to reflect the care provided to the patient and a generic statement on the procedural consents meant that other providers might participate in the surgical procedures. B. Interviews i. On 10/30/24 at 4:12 p.m., an interview was conducted with vice president of quality (VP) #8. VP #8 stated the facility completed a full investigation of Patient #4’s serious event. VP #8 stated they concluded from a system and process standpoint, all went according to plan and the event was a surgical error. VP #8 stated the facility did not suspend Provider #5 during the investigation and implemented the process of transplant surgeon consultation for patients with a history of kidney transplants. VP #8 stated the transplant surgeon would make the decision of whether or not to be present in the OR for the surgical procedure. VP #8’s explanation of their new process of implementing only a consult with the transplant surgeon failed to acknowledge the failure with Patient #4’s procedure occurred within the operating room when their anatomy unexpectedly changed. The facility’s response fell short of keeping all patients safe within the operating room and was in contrast to the Patient Rights and Responsibility policy which read, patients have the right to receive high-quality, safe, and professional care. Furthermore, it was in contrast to the AORN position statement on patient safety which read, severe, preventable injury and harm should never occur in the perioperative practice setting. Health care providers must collaborate on interdisciplinary teams to establish and sustain an organizational culture of patient safety by developing initiatives aimed at reducing errors, engaging patients to participate in their own care and creating an environment that is safe for patients. ii. On 11/4/24 at 10:09 a.m., an interview was conducted with patient safety director (Director) #12. Director #12 stated the purpose of the quality team was to ensure regulatory compliance, offer process support, and track data to help understand the processes within the facility. Director #12 stated they facilitated the SEA for Patient #4 and facility leadership initiated the plan for a multi-disciplinary team review of transplant history patients into place the day after the sentinel event. Director #2 stated the facility could put things in place to help support patient safety, but did not want to tell medical staff how to practice. Director #12 stated they were unsure if the sentinel event was unavoidable or if the presence of a transplant surgeon in the room would have changed the outcome. Director #12 stated the SEA revealed the only person who could have done something different would have been the surgeon. Director #12 stated when the facility implemented processes, it provided protection against patient harm, however sometimes errors happened which caused harmful consequences despite the processes in place. Director #12’s interview was in contrast with the Serious Safety Event policy, which read, recognizing human error was not an acceptable root cause. iii. On 11/4/24 at 2:10 p.m., an additional interview was conducted with vice president of quality (VP) #8. VP #8 stated they were unclear about the occurrence follow up which involved Surgeon #1, who left the OR while physician assistant (Provider) #2 continued the surgical procedure on Patient #5. VP #8 stated the investigation had been turned over to the peer review process.”

“INFORMED CONSENT CFR(s): 482.51(b)(2) A properly executed informed consent form for the operation must be in the patient’s chart before surgery, except in emergencies. This Standard is not met as evidenced by: 47962 Based on observations, interviews, and document review, the facility failed to ensure procedural consents for surgery included the names of all participating surgical practitioners. This failure impacted four of four pediatric surgical patients’ medical records reviewed (Patients #5, #7-9). Findings include: Facility policies: According to the Informed Consent for or Refusal of Treatment, Surgery, Procedures, or Plan of Care policy, it is the responsibility of the practitioner who will perform the specific treatment, surgery, or procedure to obtain a valid informed consent and secure an executed consent form. Informed consent relates to the patient’s consent to surgery, procedures, or services that are complex in nature and/or involve risks and alternatives that are not commonly known or understood. A valid consent must inform the patient or decision-maker of the name of the practitioner performing the procedure as well as the names and specific significant surgical tasks that will be conducted by practitioners other than the primary surgeon and whether residents or non-physician practitioners will be involved in the treatment, surgery, or procedure and if so, the nature of their involvement. Separate consents, obtained by the practitioner, are needed for each procedure, in accordance with the practitioner’s role in the procedure. According to the Credentials policy Appendix A, advanced practice professionals include physician assistants. References: According to the Medical Staff Rules and Regulations, upon admission, the facility obtains a general consent for treatment. This general consent does not eliminate the need for each practitioner to obtain informed consent from the patient or the patient’s authorized representative for specific treatments or procedures. According to the Medical Staff Bylaws, advanced practice professionals are those practitioners listed in Appendix A. They are granted clinical privileges and permission to practice under a defined degree of direction from a physician. 1. The facility failed to ensure procedural consents for surgery included the names of all participating surgical practitioners. A. Document review i. A review of the occurrences revealed on 8/8/24, physician assistant (Provider) #2 performed surgery on Patient #5 without physician (Surgeon) #1 present but with Surgeon #1’s permission. In the occurrence follow-up, staff documented Surgeon #1 made the incision, inserted the scope (camera), and let Provider #2 take over the scope. Quality assurance staff documented Surgeon #1 had left the operating room (OR) during the surgical procedure. ii. A review of medical records for Patients #5 and #9 revealed their procedural consent listed only one surgical practitioner, Surgeon #1, although Provider #2 also operated on these patients. a. A review of Patient #5’s medical record for their surgical procedure on 8/8/24 revealed the procedure consent contained spaces for the patient name, authorizing “Dr(s)” name with a space, and “to do” with a space. The doctor listed was Surgeon #1 and in the to do space was handwritten “left knee arthroscopy (a surgical procedure that allows a surgeon to examine and treat a joint’s interior), removal of hardware, medial (inner) patellofemoral (knee to thigh bone) ligament (MPFL) reconstruction (replacement of a ligament in the knee) and any indicated procedures.” In Patient #5’s operative report, Surgeon #1 documented Provider #2 assisted with “key aspects” of the procedure including “positioning and closure.” Surgeon #1 documented “I made medial and lateral arthroscopic (using a camera) portals (incisions). They also documented “I entered the joint with a scope” and “I arthroscopically removed five screws.” The informed consent and operative report which documented only Surgeon #1’s involvement in Patient #5’s surgery (apart from Provider #2’s assistance with positioning and closure), was in contrast to the occurrence on 8/8/24 for Patient #5 which reported Provider #2 performed part of the surgery. This was also in contrast to an interview conducted with Provider #2 on 11/5/24 at 9:11 a.m. During this interview, Provider #2 stated they had operated on Patient #5, including incising and removing hardware, even when Surgeon #1 was absent from the OR. Provider #2 stated patients had the right to know the extent of all providers’ involvement in surgical procedures. b. A review of Patient #9’s medical record for their surgical procedure on 8/8/24 revealed the procedure consent listed only Surgeon #1. The consent documented the procedure was “left knee open De Novo implantation trochlea (implantation of cartilage), possible patella MPFL reconstruction, procedures as indicated.” In Patient #9’s operative report, Surgeon #1 documented Provider #2 assisted with “key portions” of the procedure including “graft preparation and closure.” Surgeon #1 documented “I made an incision along the medial border of the patella.” They also documented “I made a medial parapatellar (next to the knee cap) arthrotomy (created an opening in the joint).” The informed consent and operative report which documented only Surgeon #1’s involvement in Patient #9’s surgery (apart from Provider #2’s assistance with graft preparation and closure), was in contrast to an interview conducted with Provider #2 on 11/5/24 at 9:11 a.m. During this interview, Provider #2 stated they made the initial incisions for the scopes, scoped, and removed screws during arthroscopic procedures when working with Surgeon #1, often during times Surgeon #1 was absent from the OR. Provider #2 stated patients had the right to know the extent of all providers’ involvement in surgical procedures. iii. A review of Patient #7 and #8’s medical records from their surgical procedures on 9/26/24 revealed their procedural consent forms listed only Surgeon #1 as the surgical practitioner and Surgeon #1 was also listed as being present in both ORs at the same time. Patient #7’s surgical case record documented Surgeon #1 entered the OR on 9/26/24 at 10:15 a.m. and left the OR at 11:56 a.m. Patient #8’s surgical case record documented Surgeon #1 entered the OR on 9/26/24 at 11:32 a.m. and left the OR at 1:37 p.m. Surgeon #1’s presence in Patient #8’s OR from 11:32 a.m. to 1:37 p.m. was in contrast to the documentation of their presence in Patient #7’s OR from 10:15 a.m. to 11:56 a.m. The surgical case record documented Surgeon #1 as present in both ORs on 9/26/24 from 11:32 a.m. to 11:56 a.m., a period of 24 minutes. Additionally, Patient #8’s procedure consent was signed by the surgeon at 10:07 a.m. and by the patient and the patient’s guardian at 10:40 a.m. Patient #7’s medical record failed to reveal that Surgeon #1 left Patient #7’s OR between 10:15 a.m. to 11:56 a.m., when Surgeon #1 obtained procedural consent from Patient #8 and entered Patient #8’s OR. This review of occurrences, medical records for Patients #5 and #9, and interviews with staff, revealed Surgeon #1 left the OR during surgical procedures leaving Provider #2 operating on surgical patients. This review of medical records for Patients #7 and #8 also revealed Surgeon #1 left the OR during surgical procedures leaving their physician assistant, who was not mentioned in the procedural consent, with their surgical patients. A review of the procedural consents failed to reveal the patients and their guardians consented to any practitioner other than Surgeon #1 operating on them. This lack of informed consent for all surgical practitioners involved was in contrast to the Informed Consent for or Refusal of Treatment, Surgery, Procedures, or Plan of Care policy which read, a valid consent informed the patient or decision-maker of the name of the practitioner performing the procedure and whether non-physician practitioners were involved in the surgery and if so, the nature of their involvement. B. Interviews i. On 11/4/24 at 4:40 p.m., an interview was conducted with scrub technologist (Tech) #3. Tech #3 stated on 8/8/24, they observed Surgeon #1 leave the OR and Provider #2 operate on Patient #5 before Surgeon #1 returned. They stated they had not observed any of the other surgeons at the facility leave the OR during surgical procedures. ii. On 11/5/24 at 8:54 a.m., an interview was conducted with registered nurse (RN) #9. RN #9 stated they were a nurse in the OR. They stated they documented surgical start and stop times along with the personnel who were present in the OR. RN #9 stated surgeons typically did not leave the OR if they were the only surgeon present but if they did, RN #9 would document the times they entered and exited the room, which was in contrast to a review of the medical records. RN #9 stated accurate documentation in the medical record was important for understanding how the surgical cases unfolded. iii. On 11/5/24 at 9:11 a.m., an interview was conducted with Provider #2. Provider #2 stated their role was surgeon-dependent, however, they assisted before, after, and during surgical procedures. Provider #2 stated Surgeon #1 typically directed them to make incisions and then asked them to start the arthroscopy, enter the joint space, and remove screws while Surgeon #1 was absent from the OR. They stated Surgeon #1 left the OR often for reasons including consenting other patients, and Surgeon #1 completed the bulk of the surgical procedure when they returned. Provider #2 stated they informed the patients they would participate in the surgical procedure however, Provider #2 was not aware of their exact role until the surgery began and Surgeon #1 gave them instructions. Provider #2 stated patients and their families had the right to know the extent of Provider #2’s involvement in surgical procedures. They stated Surgeon #1 was responsible for including this in their preoperative discussion about consent with patients and their guardians. iv. On 11/5/24 at 10:25 a.m. an interview was conducted with the director of quality (Director) #4. Director #4 stated accurate documentation was important to reflect the care provided to the patient. They stated the procedural consents contained a generic statement that other providers might participate in the surgical procedures and this was explained by the surgeons to the patients. Director #4 stated the patients’ signatures on the consents meant the surgeons had explained the presence of and role of all providers participating in their care. Director #4 stated the facility did not require the surgeon to delineate the role of other surgical providers during the consent process. They stated if the surgeon happened to leave the room, the other providers were covered under the surgeon’s scope and signed consent. This interview was in contrast to the Informed Consent for or Refusal of Treatment, Surgery, Procedures, or Plan of Care policy which read, a valid consent informed the patient or decision-maker of the name of the practitioner performing the procedure and whether non-physician practitioners were involved in the surgery and if so, the nature of their involvement. v. On 11/4/24 at 2:11 p.m. and 3:36 p.m., interviews were conducted with the vice president of quality (VP) #8. VP #8 stated they had investigated the occurrence involving Patient #5 on 8/8/24. They stated it was unclear what was or was not done by Provider #2 during this patient’s surgery. VP #8 stated they learned from the staff present during Patient #5’s surgery that Surgeon #1 had left the OR leaving Provider #2 scoping the patient. This interview was in contrast to Patient #5’s procedural consent which failed to reveal consent for Provider #2’s surgical role.”

“OPERATIVE REPORT CFR(s): 482.51(b)(6) An operative report describing techniques, findings, and tissues removed or altered must be written or dictated immediately following surgery and signed by the surgeon. This Standard is not met as evidenced by: 47962 Based on interviews and document review, the facility failed to ensure operative reports were complete and accurate. This failure impacted one of four pediatric surgical patients’ medical records reviewed (Patients #5). Findings include: Facility policy: According to the Documentation in the Medical Record [Adult and Pediatric] policy, the purpose is to provide the standards for documentation in the medical record by all employees and physicians who document in the medical record. Ongoing patient care will be documented; consistent with the individual type of assessment, intervention, and outcomes. Reference: According to the Medical Staff Rules and Regulations, the attending practitioner is responsible for the completion of a medical record for each patient from admission to discharge. To facilitate consistency and continuity in patient care, the patient record contains specific data and information including all operative and other invasive procedures performed. Health records of patients undergoing surgery shall also include a complete description of operative procedures including the name of the surgeon and assistant recorded and signed by the attending surgeon. Operative and special procedure reports must contain a detailed account of the findings, a complete description of the procedure used, and the name of the practitioner performing the procedure and any assistants. 1. The facility failed to ensure operative reports were complete and accurate. A. Document review i. A review of the occurrences revealed on 8/8/24, physician assistant (Provider) #2 performed surgery on Patient #5 without physician (Surgeon) #1 present but with Surgeon #1’s permission. In the occurrence follow-up, staff documented Surgeon #1 made the incision, inserted the scope (camera), and let Provider #2 take over the scope. Quality assurance staff documented Surgeon #1 had left the operating room (OR) during the surgical procedure. a. A review of Patient #5’s medical record revealed Patient #5 had surgery on 8/8/24 for patellar (knee cap) instability and to remove hardware implanted after a fracture (broken bone) of the femur (thigh bone). In the operative report, Surgeon #1 documented Provider #2 assisted with “key aspects” of the procedure including “positioning and closure.” The operative report which minimized Provider #2’s involvement to positioning and closure was in contrast to the occurrence report which documented Surgeon #1 had given the scope over to Provider #2 and left the OR for an unspecified period. In the operative report, Surgeon #1 documented “I made medial and lateral arthroscopic (using a camera) portals (incisions). I entered the joint with a scope.” They further documented “I arthroscopically removed five screws.” Surgeon #1’s documentation that they had performed these specific surgical functions was in contrast to an interview conducted on 10/4/24 at 4:40 p.m. with scrub technologist (Tech) #3 who was present in the OR during Patient #5’s surgical procedure. Tech #3 stated Surgeon #1 left the OR and Provider #2 scoped the patient and removed a screw (part of Patient #5’s implanted hardware) before Surgeon #1 returned to the OR to complete the surgery. Patient #5’s operative note was also in contrast to an interview with Provider #2 on 11/5/24 at 9:11 a.m., during which Provider #2 stated they made the initial incisions for the scopes during arthroscopic procedures with Surgeon #1. They stated it was Surgeon #1’s typical practice to provide directions to Provider #2 to, for example, make incisions, scope, and remove hardware, before leaving the OR. Provider #2 stated they were unaware their role during this surgical procedure was not captured in Patient #5’s operative note. ii. A review of Patient #9’s medical record revealed Patient #9 had surgery on 8/8/24 for a cartilage lesion of the trochlea (groove at the end of the femur) and chronic patellar instability. In Patient #9’s operative report, Surgeon #1 documented Provider #2 assisted with “key portions” of the procedure including “graft preparation and closure.” Surgeon #1 documented “I made an incision along the medial border of the patella.” They also documented “I made a medial parapatellar (next to the knee cap) arthrotomy (created an opening in the joint).” Patient #9’s operative note was in contrast to an interview with Provider #2 on 11/5/24 at 9:11 a.m. during which Provider #2 stated they made the initial incisions for the scopes during arthroscopic procedures with Surgeon #1. They stated it was Surgeon #1’s typical practice to provide directions to Provider #2 to, for example, make incisions, scope, and remove hardware, before leaving the OR. B. Interviews i. On 11/4/24 at 4:40 p.m., an interview was conducted with Tech #3. Tech #3 stated they were present for Patient #5’s surgical procedure on 8/8/24. They stated Surgeon #1 left the OR after timeout (a pause by the medical team to confirm the correct patient, procedure, and site) and during this absence, Provider #2 used the scope to remove a screw from Patient #5. ii. On 11/5/24 at 9:11 a.m., an interview was conducted with Provider #2. Provider #2 stated their role was surgeon-dependent, however, they assisted before, after, and during surgical procedures. Provider #2 stated Surgeon #1 typically directed them to make incisions and then asked them to start arthroscopy, enter the joint space, and remove screws while Surgeon #1 was absent from the OR. They stated Surgeon #1 completed the bulk of the surgical procedure when they returned. Provider #2 stated Surgeon #1 was responsible for documenting the surgical procedure in the operative report. Provider #2 stated upon viewing Patient #5’s operative report, they had not seen documentation that reflected the extent of their role during this surgery. They stated they had been unaware their assistance during surgical procedures, specifically their assistance during Patient #5’s surgery, was not documented. Provider #2 stated if patients experienced problems, accurate documentation helped to clarify the role of each surgical team member. They stated accurate documentation was important for patient safety. iii. On 11/5/24 at 10:25 a.m., an interview was conducted with the director of quality (Director) #4. Director #4 stated documentation needed to reflect the care that was provided to the patient. They stated this was important to reflect the treatment and risks involved.”

“QAPI CFR(s): 482.21 The hospital must develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital’s governing body must ensure that the program reflects the complexity of the hospital’s organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. This Condition is not met as evidenced by: 44751 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.”

“INFECTION PREVENTION CONTROL ABX STEWARDSHIP CFR(s): 482.42 The hospital must have active hospital-wide programs for the surveillance, prevention, and control of HAIs and other infectious diseases, and for the optimization of antibiotic use through stewardship. The programs must demonstrate adherence to nationally recognized infection prevention and control guidelines, as well as to best practices for improving antibiotic use where applicable, and for reducing the development and transmission of HAIs and antibiotic resistant organisms. Infection prevention and control problems and antibiotic use issues identified in the programs must be addressed in collaboration with the hospital-wide quality assessment and performance improvement (QAPI) program. This Condition is not met as evidenced by: 49541 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).”

“PATIENT SAFETY CFR(s): 482.21(a), (c)(2), (e)(3) (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. This Standard is not met as evidenced by: 44751 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.”

“INFECTION CONTROL PROGRAM CFR(s): 482.42(a)(1) 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; This Standard is not met as evidenced by: 49541 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.”

“GOVERNING BODY CFR(s): 482.12 There must be an effective governing body that is legally responsible for the conduct of the hospital. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body ... This Condition is not met as evidenced by: 47959 Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the §482.12 Condition of Participation: Governing Body was out of compliance. A-0084 The governing body must ensure that the services performed under a contract are provided in a safe and effective manner. Based on interviews and document review, the facility’s governing body failed to ensure contracted services were provided in a safe and effective manner. Specifically, the governing body failed to ensure students had clinical oversight to ensure they performed within their scope of practice.”

“NURSING SERVICES CFR(s): 482.23 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse. This Condition is not met as evidenced by: 47959 Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.23 Nursing Services was out of compliance. A-0395 - A registered nurse must supervise and evaluate the nursing care for each patient. Based on document review and interviews, the facility failed to ensure staff working with students considered the student’s scope of practice for patient care assignments in one of one patients reviewed who received a transpyloric (TP) feeding tube insertion by a paramedic student (Patient #2). Additionally, the facility failed to ensure staff had access to the preceptors’ responsibilities and students’ scopes of practice when precepting students. A-0398 All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). Based on document review and interviews, the facility failed to ensure registered nurses adhered to the policies and procedures of the hospital in one of one medical records reviewed of a patient who received a transpyloric (TP) feeding tube (Patient #2). Additionally, the facility failed to ensure staff competencies for processes and procedures were validated in two of two personnel files reviewed. (registered nurse (RN) #3 and RN #15)”

“CONTRACTED SERVICES CFR(s): 482.12(e)(1) The governing body must ensure that the services performed under a contract are provided in a safe and effective manner. This Standard is not met as evidenced by: 47959 Based on document review and interviews, the facility’s governing body failed to ensure contracted services were provided in a safe and effective manner. Specifically, the governing body failed to ensure students had clinical oversight to ensure they performed within their scope of practice. (Cross-reference A-0395) Findings include: References: The Board of Trustees (Governing Board) bylaws read, the primary role of the Board of Trustees is to provide community perspective and advice to the company, thereby fulfilling responsibilities to the patient population served by the company by facilitating the establishment of policies, maintaining quality patient care. The Clinical Patient Safety and Quality Committee (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 with the facilities. The Department of Public Health and Environment Emergency Medical Services 6 CCR 1015-3 Chapter One - Rules Pertaining to EMS (emergency medical services) and EMR (emergency medical responder) Education, EMS Certification or Licensure, and EMR Registration (effective 6/14/22) read, a medical director is defined as a physician licensed in good standing who authorizes and directs, through protocols and standing orders, the performance of students-in-training enrolled in Department-recognized EMS or EMR education programs and/or EMS certificate holders or licensees who perform medical acts, and who is specifically identified as being responsible to assure the performance competency of those EMS providers as described in the physician’s medical continuous quality improvement program. Under the section for Medical Acts Allowed, paramedics are permitted to insert nasogastric (NG) tubes for gastric decompression. The insertion of a transpyloric (TP) tube or other tube for feeding purposes was not listed under the section for Medical Acts Allowed as a permitted medical act. 1. The facility failed to ensure contracted services had clinical oversight that ensured students worked within their scope of practice. A. Document Review i. The medical record of Patient #2 was reviewed. The medical record review revealed Patient #2 was a 47 day old patient admitted on 12/21/23 for acute respiratory failure related to a respiratory virus and influenza. Orders were placed for a TP tube to be placed and an abdominal x-ray for placement confirmation. The medical record review revealed Patient #2 needed the TP tube placed for nutritional feeding purposes. The medical record revealed RN #3 documented the TP tube was placed per policy at the bedside. RN #3 measured the TP tube and supervised the procedure of a paramedic student as they placed the TP tube into Patient #2. Further review revealed Patient #2 had an episode of coughing, gagging, and dropped heart rate while the tube was placed. RN #3 placed a continuous positive airway pressure machine (CPAP) (a machine that used air pressure to keep the breathing airway open) and a bi-level positive airway pressure (BIPAP) (a machine that used high air pressure to keep the breathing airway open) on the patient. After Patient #2 was calm, the tube was flushed with 10 milliliters of water before an x-ray was obtained for placement confirmation. The medical record review revealed Patient #2 experienced a pneumothorax (a collapsed lung) following the TP placement. This was in contrast with 6 CCR 1015-3, Chapter One - Rules Pertaining to EMS and EMR Education, EMS Certification or Licensure, and EMR Registration which did not include the insertion of a nasogastric tube, orogastric (OG) tube or TP tube for feeding purposes under medical acts allowed. ii. A document review of the Medical Staff Rules and Regulations was completed. The review revealed the clinical oversight for students was for medical students only. Nursing and non-nursing students, including EMS students, were not included in this oversight. iii. A document review was completed for the last 12 months of meeting minutes for the Board of Trustees, the Medical Executive Committee, and the CPSQC. The document review revealed no evidence that affiliation agreements for colleges who contracted student learning services with the facility were reviewed. (Cross-reference A-0395) B. Interviews i. On 12/27/23 at 3:20 p.m. an interview was conducted with the emergency medical services (EMS) clinical coordinator (Clinical Coordinator) #2. Clinical Coordinator #2 stated EMS students functioned under a physician’s license. Clinical Coordinator #2 stated each college had a medical director who provided the clinical oversight and was unaffiliated with the facility. Clinical Coordinator #2 stated the college medical director did not come on-site to oversee the students clinically. Clinical Coordinator #2 stated the clinical oversight was provided by the physician on-site for students in the Emergency Department (ED) or by the school medical director through evaluation forms filled out and returned by nursing preceptors. ii. On 1/3/24 at 10:21 a.m., an interview was conducted with Quality Director #6. Quality Director #6 stated the facility’s chief executive officer (CEO) did not sit on the Board of Trustees. They explained the division CEO was not available for an interview and it was recommended that questions be directed to the vice president of quality and patient safety (VP) #7. Quality Director #6 stated the facility had representation on the Board of Trustees through the CPSQC. Quality Director #6 stated information about the event with Patient #2 was presented to the CPSQC as a subset committee of the Board of Trustees. Quality Director #6 stated Patient #2’s information was not documented or entered into the meeting minutes, but rather shared as a live discussion with the members of the committee. iii. On 1/3/24 at 7:17 a.m. an interview was conducted with VP #7. VP #7 stated they acted as a liaison to the Board of Trustees. VP #7 stated they were unsure of the kind of student supervision provided by the colleges for the EMS students. VP #7 stated the bylaws of the Board of Trustees defined oversight of the board as their primary responsibility. VP #7 stated the medical staff committee provided oversight to medical students but was uncertain about EMS or other contracted services that involved students. VP #7 stated CPSQC was aware of the event involving Patient #2 because the CPSQC met weekly via phone and discussed any facility root cause analyses (RCA). VP #7 stated facility leadership had not communicated to staff that students needed oversight that included the knowledge of the student’s scope of practice. iv. On 1/3/24 at 10:35 a.m., an interview was conducted with chief medical officer (CMO) #8. CMO #8 stated the oversight for students in the facility was determined by the type of student category such as medical, nursing, or allied health. CMO #8 stated the facility did not have a process in place to provide oversight for students other than medical students. CMO #8 stated once the EMS students got to the inpatient units, there was no clinical oversight. CMO #8 then stated having clinical oversight for all students ensured the students learned the functions of their roles correctly. CMO #8 further stated having no clinical oversight presented patient safety risks and potential patient harm if students provided patient care incorrectly. v. On 1/3/24 at 1:36 p.m., an interview was conducted with the assistant vice president of academic affairs (AVP) #9. AVP #9 stated the affiliation agreements (contracts) between the colleges and the facility were managed by AVP #9 for nursing and allied health students and Clinical Coordinator #2 for EMS students. AVP #9 stated the contracts were renewed every two years for nursing students and every three years for EMS students. AVP #9 stated the contracts were approved at the corporate level of the organization and was unaware of what involvement the board had in the process. AVP #9 stated contracts were reviewed for non-clinical content such as vaccinations and background checks. AVP #9 stated this information was not reviewed by the board. AVP #9 stated all students had a staff preceptor and were evaluated through an online program. AVP #9 stated the allied health programs included dietary, EMS, health management, occupational/physical/speech therapy, phlebotomy, radiology, surgical technology, respiratory therapy, and ultrasound. AVP #9 stated these programs were not set up to have any clinical oversight from an instructor or guidance from training documents.”

“RN SUPERVISION OF NURSING CARE CFR(s): 482.23(b)(3) A registered nurse must supervise and evaluate the nursing care for each patient. This Standard is not met as evidenced by: 47959 Based on document review and interviews, the facility failed to ensure staff working with students considered the student’s scope of practice for patient care assignments in one of one patients reviewed who received a transpyloric (TP) feeding tube insertion by a paramedic student (Patient #2). Additionally, the facility failed to ensure staff had access to the preceptors’ responsibilities and students’ scopes of practice when precepting students. Findings include: Facility policy: The Observation and Shadowing policy read, the Education Affiliation Agreement is part of a formalized training program or part of a formal agreement with the facility, where they are learning under supervision to practice or improve their skills. Observation hours and student placements are directed by the Education Affiliation Agreement and are not governed by this policy. References: The Preceptor Competency Based Staged Orientation (CBSO) training information guide read, students may participate in direct patient care including any skill or task that falls within the scope of nursing practice as long as it is approved by the school, the student has been instructed on it through the school, and the student has been deemed competent to perform it under the supervision of an RN. There was no evidence referenced in the guide for emergency medical services (EMS) students. According to the The Department of Public Health and Environment Emergency Medical Services 6 CCR 1015-3, Chapter One - Rules Pertaining to EMS and EMR Education, EMS Certification or Licensure, and EMR Registration (effective 6/14/22), under the section for Medical Acts Allowed, paramedics are permitted to insert nasogastric (NG) tubes for gastric decompression. The insertion of a transpyloric (TP) tube or other tube for feeding purposes was not listed under the section for Medical Acts Allowed as a permitted medical act. 1. The facility failed to ensure staff understood the preceptor’s responsibilities or scope of practice for students they precepted during clinical rotations. A. Medical Record Review i. The medical record of Patient #2 was reviewed. The medical record review revealed Patient #2 was a 47 day old patient admitted on 12/21/23 for acute respiratory failure related to a respiratory virus and influenza. Orders were placed for a TP tube to be placed and an abdominal x-ray for placement confirmation. The medical record review revealed Patient #2 needed the TP tube placed for nutritional feeding purposes. The medical record revealed RN #3 documented the TP tube was placed per policy at the bedside. RN #3 measured the TP tube and supervised the procedure of a paramedic student as they placed the TP tube into Patient #2. Further review revealed Patient #2 had an episode of coughing, gagging, and dropped heart rate while the tube was placed. RN #3 placed a continuous positive airway pressure machine (CPAP) (a machine that used air pressure to keep the breathing airway open) and a bi-level positive airway pressure (BIPAP) (a machine that used high air pressure to keep the breathing airway open) on the patient. After Patient #2 was calm, the tube was flushed with 10 milliliters of water before an x-ray was obtained for placement confirmation. The medical record review revealed Patient #2 experienced a pneumothorax (a collapsed lung) following the TP placement. This was in contrast with 6 CCR 1015-3, Chapter One - Rules Pertaining to EMS and EMR Education, EMS Certification or Licensure, and EMR Registration which did not include the insertion of a nasogastric tube, orogastric (OG) tube or TP tube for feeding purposes under medical acts allowed. B. Document Review i. A document review of the Education Affiliation Agreement for College #1 and College #2 was reviewed. The document review revealed the facility provided supervision for educational and clinical activities that were reasonable and appropriate to the student’s level of training. ii. A document review was completed for College #2’s Emergency Medical Services (EMS) Academy Paramedic Education Program Clinical Manual. The document review revealed the scope of practice was defined in the State of Colorado Department of Public Health and Environment, Health Facilities and Emergency Medical Service Division: 6 CCP 1015-3 Appendix A Medical Acts Allowed; Appendix C. The clinical manual read, the expectation of the preceptor was to read and review the EMS student’s clinical competencies as well as any policies and procedures pertinent to the EMS student while assigned to the clinical unit. iii. A document review was completed for College #3’s Emergency Medical Services (EMS) Program Clinical Internship Policies and Procedures Manual. The document review revealed no evidence of reference to the EMS student’s scope of practice, the role of the student, or the expectations of the role of the preceptor for the EMS student. The document review revealed a preceptor feedback form filled out by the student at the end of each shift. This evaluation included whether or not the clinical preceptor allowed the student to perform the skills they were qualified to perform. The review also revealed the feedback form included whether or not the clinical preceptor took time to learn the reason the student was at the clinical and what the student could perform. iv. A document review was completed for College #1’s Emergency Room: Clinical Orientation and Objectives. The document review revealed the school followed Chapter Two of the Code of Colorado Regulations Health Facilities and Emergency Medical Services Division for the scope of practice for the EMS students. The document review revealed no evidence of the expectations of the role of the preceptor for the EMS student. v. A document review was completed for College #4’s Advanced Student Internship Manual. The document review revealed no evidence of reference to the EMS student’s scope of practice, the role of the student, or the expectations of the role of the preceptor for the EMS student. The content of these documents was in contrast to the CBSO training information guide that read any direct patient care performed by students had to fall within the scope of practice and the student had been deemed competent by the school. C. Interviews i. On 12/28/23 at 7:32 a.m., an interview was conducted with RN #3, who was precepting the EMS student who inserted the TP tube into Patient #2. RN #3 stated when they precepted an EMS student, they asked about background and experience information. RN #3 stated they reached out to the unit educator or charge nurse if they needed to know what the scope of practice was for the student. RN #3 stated they also would look up the scope of practice on the Department of Regulatory Agencies (DORA) website if they had questions. RN #3 stated they were unaware of any verbal or written scope of practice used by the RN preceptors. RN#3 stated they did not look up the EMS student’s scope of practice prior to the student inserting the NP tube into Patient #2. RN #3 stated it was not necessary because the EMS student performed the skill with RN #3’s direct supervision. ii. On 12/28/23 at 1:25 p.m., an interview was conducted with RN #11, who worked in the labor and delivery unit. RN #11 stated the labor and delivery unit did not have a reference binder for guidance on precepting EMS students. RN #11 stated if there was an immediate need to know the scope of practice, the RN asked the charge nurse. iii. On 12/28/23 at 1:50 p.m., an interview was conducted with RN #12, who worked in the pediatric unit. RN #12 stated there was no reference binder on the pediatric unit for guidance on precepting EMS students. RN #12 stated if they needed to know what the EMS student’s scope of practice was, they would look it up on the DORA website or ask the unit educator. iv. On 12/28/23 at 2:00 p.m., an interview was conducted with RNs #13 and #14, who worked in the pediatric intensive care unit (PICU). RNs #13 and #14 reported they were not aware of a reference binder that identified the EMS students’ scope of practice for the PICU. RNs #13 and #14 further reported if they had questions about the scope of practice, they asked the charge nurse or unit educator. v. On 12/27/23 at 10:15 a.m., an interview was conducted with charge nurse (CRN) #10. CRN #10 stated all RNs precepted students. CRN #10 stated preceptors needed to be advanced and experienced nurses to teach students or new hires. CRN #10 stated EMS students on the unit shadowed as well as cared for patients under the supervision of the RN. CRN #10 stated the charge nurses would ask an instructor or educator if the student’s scope of practice was not understood. vi. On 12/27/23 at 1:11 p.m., an interview was conducted with Clinical Educator #1. Clinical Educator #1 stated registered nurses (RNs) precepted emergency medical system (EMS) students that included emergency medical technicians (EMTs) and paramedic students. Clinical Educator #1 stated there were no specific precepting guidelines for the EMS students and the nurses were instructed to follow the same guidelines used for nursing students and newly hired nursing staff. Clinical Educator #1 stated the facility had a class that trained nurses to precept students and new hires, but nurses were not required to take the class before they precepted students. Clinical Educator #1 stated the guidelines informed nurses that oversight for EMS students was appropriate as long as the skill was within the EMS student’s scope of practice. Clinical Educator #1 stated the RNs who precepted EMS students needed to look up the student’s scope of practice. Clinical Educator #1 stated they did not know where the EMS scopes of practice were found and thought most staff nurses would not know where to look for information. vii. On 12/27/23 at 3:20 p.m., an interview was conducted with EMS clinical coordinator (Clinical Coordinator) #2. Clinical Coordinator #2 stated RNs received a one-page summary from the students which gave them information about precepting EMS students because most nurses did not know the scope of practice for EMS students. Clinical Coordinator #2 stated there was a notebook binder on each unit provided by the students’ schools which explained the scope of practice for the EMS students and the preceptor’s responsibilities. Clinical Coordinator #2 stated the facility followed the Department of Public Health and Environment Health Facilities and Emergency Medical Services Division Emergency Medical Services 6 CCR 1015-3 regulations as the guidance for EMS scope of practice. Clinical Coordinator #2 stated the EMS scope of practice for paramedic students included the placement of a nasogastric tube but stated they did not know what a transpyloric tube was. Clinical Coordinator #2 stated it was important for preceptors to know the EMS student’s scope of practice and if they did not know, the RN should have contacted them for direction. viii. On 1/2/24 at 4:25 p.m., an interview was conducted with the director of quality (Director) #6. Director #6 stated preceptor training was geared towards RNs and there was no training for RNs to precept EMS students. Director #6 stated there was no other facility policy for students other than the Observation and Shadowing policy, which excluded students such as the EMS students directed by the Education Affiliation Agreement. ix. On 12/28/23 at 8:26 a.m., an interview was conducted with the director of outreach and collaboration (Director #4). Director #4 stated there was a large gap of understanding in the hospital about the differences between the levels of EMS students and what they were allowed to perform within their scope of practice. Director #4 stated they placed reference notebook binders from College #2 in all the units but did not know about binders or communication from other schools. Director #4 stated RNs were told to follow the information in College #2’s binder if other notebooks were not available. Director #4 stated it was the responsibility of Clinical Coordinator #2 to get the information from the other schools to the clinical units. This was in contrast to the interviews with Clinical Educator #1 and RNs #3, #10, #11, #12, #13, and #14, who stated they were unaware of where to find the guidance for scopes of practice for precepting students.”

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 47959 Based on document review and interviews, the facility failed to ensure registered nurses adhered to the policies and procedures of the hospital in one of one medical records reviewed of a patient who received a transpyloric feeding tube (Patient #2). Additionally, the facility failed to ensure staff competencies for processes and procedures were validated in two of two personnel files reviewed. (registered nurse (RN) #3 and RN #15) Findings include: Facility policy: The Pediatric Nasogastric (NG) or Transpyloric (TP) Feeding Tube Placement and Enteral Nutrition policy read, only registered nurses (RN) with documented competency may insert NG or TP tubes independently. To reach the pylorus (the opening between the stomach and small intestine), while instilling 5-10 milliliters of air, advance the tube. Confirm placement with abdominal x-ray. References: The Elton B. Stephens Company (EBSCO) Nursing Skill: Inserting a Nasogastric Tube in Pediatric Patients (2023), provided by the facility, read, do not instill any liquids through NG tube or connect it to suction until correct placement has been confirmed. Verify proper tube placement immediately after insertion using facility-approved, evidence-based method (typically abdominal x-ray). X-ray is recommended in pediatric patients at high risk for incorrect tube placement, such as those with critical illness. The AVANOS CORFLO Nasogastric/Nasointestinal Feeding Tubes manufacturer’s instructions for use (IFU) read, misplacement of the feeding tube into trachea or lungs may result in serious injury. Confirm tube position and integrity per facility protocol. After tube position in the stomach is confirmed, remove stylet by flushing tube through the side port with up to 10 milliliters of water to activate internal lubricant immediately prior to stylet removal. 1. The facility failed to ensure staff had validated competencies for processes and procedures. Additionally, the facility failed to ensure staff followed facility guidelines and policies. A. Document review i. The medical record of Patient #2 was reviewed. The medical record review revealed Patient #2 was a 47 day old patient admitted on 12/21/23 for acute respiratory failure related to a respiratory virus and influenza. Orders were placed for a TP tube to be placed and an abdominal x-ray for placement confirmation. The medical record review revealed Patient #2 needed the TP tube placed for nutritional feeding purposes. The medical record revealed RN #3 documented the TP tube was placed per policy at the bedside. RN #3 measured the TP tube and supervised the procedure of a paramedic student as they placed the TP tube into Patient #2. Further review revealed Patient #2 had an episode of coughing, gagging, and dropped heart rate while the tube was placed. RN #3 placed a continuous positive airway pressure machine (CPAP) (a machine that used air pressure to keep the breathing airway open) and a bi-level positive airway pressure (BIPAP) (a machine that used high air pressure to keep the breathing airway open) on the patient. After Patient #2 was calm, the tube was flushed with 10 milliliters of water before an x-ray was obtained for placement confirmation. The medical record review revealed Patient #2 experienced a pneumothorax (a collapsed lung) following the TP placement. ii. A review of staff employee files revealed competencies for RN #3 were not completed for NG or TP tube placement. The review of the staff employ files revealed RN #15 completed RN #3’s orientation for the gastrointestinal (GI) disorders category of training, but there was no indication RN #3 had completed a competency for NG or TP placement. iii. A focused competency review was conducted of the staff employee file for RN #15, who completed the GI disorders category of the orientation for RN #3. The review revealed no evidence of competency for NG or TP placement for RN #15. This was in contrast to the Pediatric Nasogastric (NG) or Transpyloric (TP) Feeding Tube Placement and Enteral Nutrition policy which read, only RNs with documented competency could insert NG or TP tubes independently. B. Interviews i. On 12/28/23 at 7:32 a.m., an interview was conducted with RN #3, who provided assistance and oversight in the placement of the TP tube for Patient #2. RN #3 stated when they placed a TP tube, they measured the tube for the patient, inserted the tube into the patient’s nare, and progressed the tube into the stomach. RN #3 stated they then injected three milliliters of air into the tube and listened with a stethoscope placed on the patient’s abdomen to hear if the air entered the stomach. RN #3 stated they then injected five to 10 milliliters of water into the tube as they progressed the tube past the pylorus and into the small intestine. RN #3 stated they then pulled the stylet out of the tube, taped the tube in place to prevent movement, and obtained an x-ray for placement validation. RN #3 stated they were aware of the facility policy for NG and TP feeding tube insertion, however, RN #3 stated they did not use the policy because they were familiar with the procedure. RN #3 stated they referenced policies based on their comfort level with the procedure. RN #3 stated they were trained upon hire to place NG and TP tubes and had not changed their process to align with the policy because the tube passed into the small intestine more successfully when water was used before the x-ray validation. RN #3 stated adherence to policies was important because it ensured patients remained safe. RN #3 stated it was important that patient care aligned with policies because policies had the most updated practices and ensured the best patient outcomes. This was in contrast to the Pediatric Nasogastric (NG) or Transpyloric (TP) Feeding Tube Placement and Enteral Nutrition policy which read, only registered nurses (RN) with documented competency were to insert NG or TP tubes independently and advancement of the tube into the pylorus used air, not water. Placement was confirmed with an abdominal x-ray. Furthermore, it was in contrast to the AVANOS CORFLO Nasogastric/Nasointestinal Feeding Tubes IFU which read, the tube position and integrity were confirmed per facility protocol. After the position was confirmed, the tube was flushed with up to 10 milliliters of water before the stylet removal. Additionally, this was in contrast to the national guidelines, the EBSCO Nursing Skill Inserting a Nasogastric Tube in Pediatric Patients which read, liquids were not to be instilled through the NG tube until correct placement was confirmed. ii. On 1/2/24 at 2:24 p.m., an interview was conducted with nursing director (Director) #5. Director #5 stated staff competencies were determined by demonstration of the skill after education was completed. Director #5 stated staff competency was demonstrated initially upon hire, then annually, and also daily. Director #5 stated skills were analyzed daily by charge nurses, preceptors, and the unit educator. Director #5 stated the daily checks for competency were performed when staff were unsure of a skill, or when mistakes in performance were noticed. Director #5 stated a competency was different than educational learning. Director #5 stated competencies required demonstration to another staff member. Director #5 stated facility policies were to be followed and staff were notified of changes to policies through email, staff huddles (a meeting at the change of shift), and online learning modules. Director #5 stated the facility policy for NG and TP tube feedings was last updated and approved in August 2022. Director #5 stated the policy had never instructed the water flush to be completed before the placement validation. Director #5 was unsure of why staff flushed the tube with water before the placement was verified and stated staff may have been confused with another policy that used ultrasound as immediate placement verification. Director #5 stated patient safety was ensured when staff followed policies and presented a risk of injury or harm to patients when policies were not followed. Director #5 stated competencies were checked and maintained to ensure procedures were done correctly. Director #5 stated staff who performed procedures that were not updated risked harm to patients when competencies were not validated.”