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Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.13 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)

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.

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)

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.

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)

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.

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.