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Tag No.: A0020
Based on interview and record review, the hospital failed to follow the reporting requirements of the Health and Safety Code 1279.1 and their own policy when two adverse events, a wrong surgery Patient (Pt) 1 and a retained guidewire (Pt 2) were not reported to the California Department of Public Health (CDPH) within five days after the events were detected. These failures delayed the investigations of the incident by CDPH and had the potential to place other patients at risk of unreported adverse events that could lead to harm or death.
Findings:
1. On 6/17/21, Patient (Pt 1) went to surgery to have her left kidney removed, but instead, her spleen was surgically removed and her left kidney was left in place. The incident was reported to CDPH on July 9, 2021, 22 days after the surgery and 15 days after the pathologist reported the error to MD (Medical Doctor) 2.
During an interview on 7/13/21 at 8:45 a.m. with Risk Management Specialist (RMS) 1, RMS 1 stated incidents are reported to CDPH by the Risk Management department. RMS 1 stated the investigation of the incident went to medical staff and peer review before the Risk Management department, causing the delay in reporting to CDPH.
During an interview on 10/6/21 at 9:20 a.m. with the Director of Surgical Services (DSS), the DSS stated she was notified about the incident on 6/25/21 by the DRM. The DSS stated she notified the Vice President of Nursing (VPN) and the operating room (OR) medical director. The DSS stated they started the investigation on 6/28/21.
During an interview on 10/4/21 at 4:20 p.m., the Director of Risk Management (DRM) stated the incident wasn't reported initially because it was considered to be a Medical Staff issue.
During a review of a letter from the hospital to CDPH dated 7/9/21 and signed by the Director of Quality, Accreditation, & Regulatory (DQ), the letter indicated,
" ...On 6/24 the pathology report indicated the specimen was a spleen not a kidney. CT scan confirmed Spleen had been removed, left kidney still in place ..."
During a review of the facility's policy and procedure (P&P) titled, "Adverse Event Reporting to the California Department of Health Services," dated 7/2020, the P&P indicated, "To comply with the mandated reporting requirements of Health and Safety Code 1279.1 (b). To support the improvement of patient safety and quality improvement initiatives ... Adverse event includes any of the following: Surgery performed on a wrong body part that is inconsistent with the documented informed consent for that patient ... It shall be the policy of [hospital name] to report an adverse event, as define within Health Safety Code 1279.1, to the California Department of Public Health (CDPH) no later than five days after the event has been detected; or, if the event is an ongoing urgent or emergent threat to the welfare, health, or safety of patients ... not later than twenty-four (24) hours after the adverse event has been detected ... All adverse events which may be considered reportable as defined by this policy shall be reported to the Supervisor/Manager immediately by involved staff and an Incident Reporting Intranet System (IRIS) completed within 24 hours ...It will be the responsibility of the Risk Manager to develop and submit the initial report to the CDPH, as well as serve as liaison with the agency during subsequent investigation process ..."
2. On 6/6/21, Pt 2 underwent a surgical procedure, and a piece of guidewire (a wire used to help place a central venous catheter (CVC) (CVC-a catheter placed into a large vein to give fluids or medications) was left in Pt 2 by the Anesthesiologist (physicians who monitor and care for patients who are administered anesthesia during surgeries). The incident was not reported to CDPH.
During an interview on 10/4/21, at 10:30 a.m., with the Director of Quality (DQ) and Director of Risk Management (DRM), the DRM stated she had not reported the incident to CDPH. On 10/12/21, the survey being conducted by CDPH concluded, and the incident still had not been reported after 11 days.
During a review of the facility's policy and procedure (P&P) titled, "Adverse Event Reporting to the California Department of Health Services," dated 7/2020, the P&P indicated, "To comply with the mandated reporting requirements of Health and Safety Code 1279.1 (b). To support the improvement of patient safety and quality improvement initiatives ... Adverse event includes any of the following: ...Retention of foreign object in a patient after surgery or other procedure ... It shall be the policy of Community Medical Centers (CMC) to report an adverse event, as define within Health Safety Code 1279.1, to the California Department of Public Health (CDPH) no later than five days after the event has been detected...It will be the responsibility of the Risk Manager to develop and submit the initial report to the CDPH, as well as serve as liaison with the agency during subsequent investigation process ..."
The Health and Safety Code, Division 2, Licensing Provisions [1200 - 1796.70], Chapter 2
Health Facilities [1250 - 1339.59], Article 3. Regulations [1275 - 1289.5] indicates:
"1279.1.
(a) A health facility licensed pursuant to subdivision (a), (b), or (f) of Section 1250 shall report an adverse event to the department no later than five days after the adverse event has been detected, or, if that event is an ongoing urgent or emergent threat to the welfare, health, or safety of patients, personnel, or visitors, not later than 24 hours after the adverse event has been detected. Disclosure of individually identifiable patient information shall be consistent with applicable law.
(b) For purposes of this section, "adverse event" includes any of the following:
(1) Surgical events, including the following:
(A) Surgery performed on a wrong body part that is inconsistent with the documented informed consent for that patient. A reportable event under this subparagraph does not include a situation requiring prompt action that occurs in the course of surgery or a situation that is so urgent as to preclude obtaining informed consent...
(D) Retention of a foreign object in a patient after surgery or other procedure, excluding objects intentionally implanted as part of a planned intervention and objects present prior to surgery that are intentionally retained..."
The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality healthcare in a safe and responsible manner.
Tag No.: A0043
Based on interview and record review, the facility failed to have an effective Governing Body which was held legally responsible for the conduct of the hospital when:
1) The Medical Staff were not accountable to the Governing Body for the quality of care provided to patients. Patient 1 was consented, scheduled and underwent a laparoscopic left nephrectomy and Patient 1's spleen was removed rather than the left kidney. The diseased left kidney remained in Patient 1. The surgeon (MD 1) was not privileged to perform the laparoscopic nephrectomy and the quality of care for Patient 1 was not ensured. (refer to A49).
2) Medical Staff did not enforce Medical Staff Bylaws for MD 1 who was expected to adhere to the rules for privileging and to adequately prepare for each surgery. MD 1 did not submit an application for advanced privileges to obtain approval to perform the laparoscopic left nephrectomy for Patient 1 prior to the scheduling of the surgery. MD 1 performed the surgery without being proctored and removed Patient 1's spleen, and the left kidney which should have been removed, remained in Patient 1. (refer to A353)
3. The Quality Assessment and Performance Improvement (QAPI) program did not effectively analyze and conduct an adequate Root Cause Analysis for the situation where Patient 1's spleen was removed rather than the left kidney which was the consented procedure. The QAPI analysis did not include the factors that led to MD 1 performing a surgery for which he was not privileged and did not consider nor analyze additional factors that may have contributed to the adverse event. (refer to A286)
The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality healthcare in a safe and responsible manner.
Tag No.: A0049
Based on interviews and administrative document reviews, the Governing Body (GB) failed to hold the Medical Staff accountable for the quality of care provided to patients when Medical Doctor (MD) 1 performed an advanced laparoscopic surgical procedure without being assessed for competence and without first submitting an application for approval to be privileged for this type of surgical procedure.
This failure resulted in the inadvertent removal of Pt 1 ' s spleen instead of her diseased left kidney, an error which was not discovered until one week after surgery, and placed Pt 1 at risk for harm due to the need for removal of the diseased left kidney and the effects of the loss of her spleen.
Findings:
A review of Pt 1's medical record indicated Pt.1 was a 54 year old female with history of left kidney disease. Pt 1's frequent bouts of left kidney disease had been complicated by left kidney stone formation which led to numerous left kidney infections which required hospitalizations and antibiotics to resolve. These infections severely and permanently damaged the left kidney and decreased its normal function significantly. An imaging study (CT scan) performed on 5/20/21 revealed her left kidney to be atrophic (smaller than normal). A nuclear medicine renal scan (test which measures the kidney's function) performed on 5/18/21 showed her left kidney function was markedly decreased (15%) from the expected normal. Pt 1 was seen by MD1 in the facility on 6/4/21 and counseled to undergo a left laparoscopic (a surgical technique in which several small incisions [cuts] are made, and tubes are inserted. A laparoscope [a tool with a light and camera] and other instruments used to cut and sew tissue are inserted through those tubes allowing the surgeon to perform the procedure without making a large incision) nephrectomy (removal of kidney) as a mean of alleviating her left kidney infections. Pt 1 signed a surgical consent form for a left laparoscopic nephrectomy to be performed by MD 1 and MD 2 on 6/17/21. The consent form indicated "laparoscopic left nephrectomy versus possible open conversion".
During a concurrent interview and credential file review on 10/4/21 at 1:30 PM with Medical Staff Director (MSD), the credential file for MD 1 was reviewed. The file indicated MD 1 began working at the facility as a locum tenens urologist (physician dealing with surgical disease of the urinary system) in 11/20. On 2/11/21 upon approval of the Board of Trustees he was granted Primary Privileges in Urology and Lasers as an Associate member of the medical staff. On 3/11/21 upon the approval of the Board of Trustees of the facility, his additional surgical privileges were granted in the Department of Surgery at the facility as an Associate member of the Medical Staff. MSD stated MD 1 never requested advanced laparoscopic privileges during the application or appointment process consequently MD 1 was never assessed for competence for advanced laparoscopic privileges, and he was never granted the privilege for advanced laparoscopic/minimally invasive procedures.
During a concurrent interview and credential file review on 10/4/21 at 1:40 PM with the MSD, the credential file for MD 2 was reviewed. The MSD stated MD 2 had been on the Medical Staff of the facility for decades had never requested advanced laparoscopic privileges during his tenure as a Medical Staff member and has never been granted the privilege for advanced laparoscopic/minimally invasive procedures.
During an interview on 10/6/21 at 9:20 a.m. with the Director of Surgical Services (DSS), the DSS stated she was made aware of the wrong organ removal surgery on 6/25/21 by the Director of Risk Management (DRM). DSS stated she immediately contacted the Medical Director of Surgical Services (CS), the VP of Operations, and the VP of Nursing. She stated the facility started their investigation on 6/28/21 by interviewing staff. DSS stated from her perspective the root cause of the incident could be attributed to the fact that neither the scheduler or the circulating nurse checked MD1's privileges prior to his starting the case.
During a concurrent interview and record review on 10/4/21 at 1:50 pm with the DRM, the Root Cause Analysis (RCA) was reviewed. DRM stated she had handled the RCA as the risk manager. She stated the root cause for the wrong organ surgery was a "dynamic abdomen with multiple co-morbidities making surgery challenging to distinguish specific organs".
During an interview on 10/6/21 at 9:45 AM with Surgical Services Manager (SSM), the SSM stated there is a process for checking privileges before scheduling a surgery case. SSM stated the Nurse Practitioner (NP) from MD 2's office had called and scheduled the operating room time for MD 1 and MD 2. SSM stated neither physician had the appropriate privileges to warrant the scheduling of an advanced laparoscopic procedure. SSM stated there was a failure to check the privileges for MD1 as well as MD 2 before the case was scheduled. SSM stated the surgery scheduler should have checked the privileges of both physicians prior to scheduling the case, however, she failed to do so.
During an interview on 10/6/21 at 2:44 PM with the Surgery Scheduler (SS), the SS stated she had been in the position for 5 years. SS stated she was called by a NP (in MD 2's office) and asked to schedule a block of time in the surgery suite for MD 2 and MD 1. SS stated she was led to believe MD 2 would be the primary surgeon with MD1 acting as the assistant. SS stated she was supposed to check the privileges for both physicians before scheduling the time, however, she simply forgot to do so. SS stated neither MD 1 nor MD 2 had advanced laparoscopic privileges. SS stated had she checked the privileges the surgery would have never been scheduled.
During an interview on 10/5/21 at 3:20 PM with the Circulating Nurse (CN), the CN stated she was a surgery circulator on 6/17/21 during the case with Patient 1. CN stated she was supposed to check the privileges for MD 1, however, she simply forgot to do so. CN stated neither MD 1 nor MD 2 had advanced laparoscopic privileges.
During an interview on 10/5/21 at 10:30 a.m. with the Director of Quality (DQ), the DQ stated he had been involved in investigating the incident and had helped to develop the action plan to prevent recurrence. DQ stated Pt 1 did not receive quality care when the wrong organ was removed.
During an interview on 10/6/21 at 4:45 p.m. with the Chairman of the Surgery Department (CS), the CS stated he was the chairman of the surgery department and the medical director of the operating room and was privileged to perform advanced laparoscopic surgery. CS stated he had been involved in reviewing the advanced laparoscopic case performed by MD 1. CS stated MD 1 and MD 2 had been removed from the surgical schedule for a period of time as the case was being reviewed by the Medical Executive Committee and the AD Hoc committee. CS stated MD1 had not been granted the appropriate privileges to perform an advanced laparoscopic procedure and in fact MD 1 had never requested the privilege. CS stated it was his expectation as the surgical chair that all the surgeons should be aware of their privileges. CS stated his expectation was that MD1 should have been adequately prepared to perform the case, and in his opinion MD1 had lacked preparation for the procedure when the spleen was removed instead of the kidney. CS stated in his opinion MD 1 had not reviewed the CT scan prior to surgery. CS stated in his opinion MD1 had not familiarized himself with the appropriate anatomical landmarks as he performed the procedure. CS stated in his opinion MD1 had used poor judgement during the procedure in terms of managing the exposure of the surgical field and in failing to convert from a laparoscopic procedure to an open procedure as the case progressed. He stated MD 1's "hubris" had caused him to make judgement errors during the procedure. CS stated Pt. 1 did not receive quality care.
During an interview on 10/8/21 at 10:45 AM with both DQ and VPQ, VPQ stated systems had been put in place to educate staff regarding physician privileges. VPQ stated leadership had put a monitoring system in place to ensure privileges were in fact being checked. VPQ stated Pt 1 did not receive quality care.
During an interview on 10/7/21 at 10:45 am with MD 2, MD 2 stated he was present in the operating room with MD1 on two brief occasions during the case on 6/17/21. MD 2 stated he was there in case MD 1 decided to convert to an open procedure in lieu of continuing with the advanced laparoscopic procedure. He stated he did recall MD 1 making a comment about a lot of adhesions, but otherwise the surgery seemed to be progressing smoothly. MD 2 stated he did not have advanced laparoscopic privileges on 6/17/21 and was not qualified to evaluate MD 1's surgical technique. MD 2 stated he was made aware after the surgery that MD 1 did not have advanced laparoscopic privileges on 6/17/21. MD 2 stated at the time of the surgery he assumed MD 1 had the privilege. MD 2 stated he informed the patient the wrong organ had been removed after the pathology report was received about a week after surgery. MD 2 stated Pt 1 did not receive quality care because "we did not give her [Pt 1] the operation she needed."
During an interview on 10/6/21 at 2:00 pm with MD 3, MD 3 stated he was a pathologist (physician who deals with tissue examination and microscopic diagnosis). MD 3 stated he had been asked to evaluate a microscopic slide from the organ that had been removed from Pt. 1 by MD1 on 6/17/21. MD 3 stated he also evaluated the organ from which the slide had been made. MD 3 stated both evaluations revealed the organ to be a spleen and not a kidney as it had been labeled when it was received in the pathology laboratory.
During an interview on 10/6/21 at 3:00 p.m. with MD 4, MD 4 stated he was a pathologist and had been asked to evaluate a microscopic slide from the organ that had been removed from Pt. 1 by MD1 on 6/17/21. MD 4 stated the microscopic evaluation revealed the organ to be a spleen and not a kidney as it had been labeled when it was received in the pathology laboratory.
During an interview on 10/7/21 at 11:07 a.m. with MDQ, MDQ stated MD 1 and PA 1 were not willing to be interviewed by the survey team during the federal survey process.
During an interview on 10/8/21 at 10:00 a.m. with the Governing Body (GB), the GB stated they had been notified of the incident when the pathology report was released about a week after the incident. The GB stated their understanding of what occurred was that the wrong organ had been surgically removed. The GB stated they were involved in the following up the incident and ensuring quality of care in the facility. The GB stated a performance improvement plan had been developed by the MEC for MD1. The GB stated the plan had been put in place for additional proctoring for MD1 as a means of restoring MD1's surgical privileges. The GB stated the proctoring plan for MD1 involved concurrent monitoring of his surgical cases including laparoscopic cases.
A review of the facility MEDICAL STAFF BYLAWS Volume I: Governance, Structure and Function of the Medical Staff dated 2/4/20, indicated, " ...1.1 Purpose of the Medical Staff- The Medical Staff of the [facility] is established by the [facility] Board of Trustees to assist [the facility] in meeting its mission and carrying out duties assigned to it by the Board in order to enhance the quality and safety of care, treatment, and services provided to patients. 1.2 Medical Staff Right of Self-Governance- The Medical Staff's right of self-governance shall include, but is not limited to, the following: b. Establishing and enforcing criteria and standards for membership and privileges; Establishing clinical criteria and standards to oversee and manage quality assurance utilization review and other Medical Staff activities ... "
A review of the facility Medical Staff Credentials Policy (#24920) dated 12/10/20, indicated, " ... III Policy D. Applicant's Responsibility and Burden of Producing Information 2. Applicant must ensure information contained on the application and other documents are accurate and complete. 6. Applicant shall have the burden of producing sufficient information of clinical and professional performance and current competence to permit an adequate evaluation of the applicant's qualifications and suitability for the clinical privileges and staff category requested, to resolve any reasonable doubts about the matters, and to satisfy any request for information ..."
A review of the facility MEDICAL STAFF BYLAWS Volume I: Governance, Structure and Function of the Medical Staff dated 2/4/20, indicated, " ...2.3 Responsibilities of Membership: Each member of the Medical Staff and all Practitioners holding privileges must continuously comply with the provisions of these Bylaws, Medical Staff and [Facility] Hospital manuals, rules, regulations, and policies. Members must: a. Provide, to the satisfaction of the Medical Executive Committee, for continuous, adequate, and timely care to all patients for whom the Practitioner has responsibility; f. Seek appropriate consultation whenever necessary to promote adequate quality of care; Furthermore, each member of the Medical Staff by accepting Medical Staff appointment or privileges agrees; m. To abide by these bylaws and Medical Staff manuals, Medical Staff policies, rules and regulations, and [Facility] Hospital policies and procedures, q. To provide patient care and management only within the parameters of his/her professional competence, as reflected in the scope of clinical privileges granted the practitioner by the Board ..."
A review of the facility MEDICAL STAFF BYLAWS Volume I: Governance, Structure and Function of the Medical Staff dated 2/4/20, indicated, " ... 2.4.2 Associate Staff b. PREROGATIVES: Appointees to this category may: 1) Exercise those privileges granted by the Board. c. RESPONSIBILITIES: Appointees to this category must: 3) Comply with all applicable [Facility] and Medical Staff Bylaws, rules, regulations, policies and procedures ..."
A review of Laparoscopic Renal Surgery for Benign Disease (Liao, J., Breda, A., and Schulam, P.) indicated, " ...For left nephrectomy... The Gerota's fascia is incised near the lower pole to identify the ureter. The gonadal vein is identified at this time and left intact. The plane of dissection is lateral to the gonadal vein, which we do not routinely divide. Particularly on the left side, by staying lateral to the gonadal, unnecessary dissection of the lumbar vein(s) is obviated. The ureter and the lower pole are now elevated with a blunt instrument and the Gerota ' s fascia is swept off the capsule. Alternatively, if significant inflammation and fibrosis are encountered, Gerota's fascia can be used as a plane of dissection and be swept free from the psoas muscle, as in radical nephrectomy. With the ureter elevated along with the lower pole of the kidney, the dissection marches towards the renal hilum. After identifying the renal vein, a plane between the vein and artery is developed. With adequate elevation on the kidney, the endoscopic vascular stapler can be safely placed across the artery using the 12 mm port followed by the renal vein in a similar fashion ... "
A review of Medical complications following splenectomy (R. Buzele, L. Barbier, A. Sauvanet, B. Fantin) indicated on page 17, " ...During the last three decades it has become clear that removal of the spleen, for any reason, is not a benign procedure. In both adults and children splenectomy places the patient at significantly higher risk of overwhelming infection, compared to the normal population. Because splenectomy may be attended by infectious and thrombotic complications, the splenectomized patient requires careful monitoring in the early postoperative period as well as in medium and long-term follow-up. Patient education, antibiotic prophylaxis and regular updating of vaccinations are key elements of management. There are no specific recommendations for the prevention of thrombotic complications, but special attention should be paid to the detection of thrombosis of the porto-mesenteric and caval venous systems, where the risk is increased, especially in cases of myeloproliferative disease or cirrhosis. The risk of the post-splenectomy septic (overwhelming bacterial blood infection) syndrome is lifelong and is not eliminated by the administration of pneumococcal vaccine (vaccine which prevents bacterial pneumonia). In addition to this late complication, splenectomy increases the frequency of adverse events, including death, in the immediate postoperative period. Infections, particularly pulmonary (lung) and abdominal sepsis, constitute the majority of the complications. The mortality rate from postoperative sepsis is substantial. A number of post-operative complications including bleeding at the operative site are also relatively common occurrences following splenic removal. As a result of these possible complications surgeons are justifiably wary of incidental splenectomy ... "
Tag No.: A0263
Based on interview and record review, the hospital failed to develop, implement and maintain an effective quality assessment and performance improvement (QAPI) program when:
1. Patient (Pt) 1's wrong organ surgery was not fully analyzed to determine the factors and root cause or causes that led to the spleen being removed rather than the left kidney. The root cause listed on the document submitted for review indicated Pt 1's "dynamic abdomen" and did not list other factors such as the primary surgeon was not privileged to perform the laparoscopic left nephrectomy. In addition, this adverse event was not reported to California Department of Public Health (CDPH) within the required timeframe. (refer to A286, Finding 1)
2. The incident of a retained guidewire in Pt 2 was not investigated or reported within the required timeframe. (refer to A286, Finding 2)
3. Multiple intravenous line infiltrations in Pt 4 were not reported via the hospital's internal reporting system in accordance with nursing policy and procedures for reporting incidents.
(refer to A286, Finding 3)
The cumulative effects of these systemic problems resulted in the hospital's inability to ensure the provision of quality healthcare in a safe and responsible manner.
Tag No.: A0286
Based on interview and record review, the hospital failed to fully implement its Quality Assessment and Performance Improvement program when:
1. Patient (Pt) 1's wrong organ surgery was not fully analyzed to determine the factors and root cause or causes that led to the spleen being removed rather than the left kidney. The root cause listed on the document submitted for review indicated Pt 1's "dynamic abdomen" and did not list other factors such as the primary surgeon was not privileged to perform the laparoscopic left nephrectomy. In addition, this adverse event was not reported to California Department of Public Health (CDPH) within the required timeframe.
2. The incident of a retained guidewire in Pt 2 was not investigated or reported within the required timeframe.
3. Multiple intravenous line infiltrations in Pt 4 were not reported via the hospital's internal reporting system in accordance with nursing policy and procedures for reporting incidents.
These failures interfered with timely investigation into the root causes and contributing factors of these events and delayed implementation of action plans to prevent recurrence, and caused potential harm to all patients due to failure to thoroughly investigate root causes.
Findings:
1. On 6/17/21, Pt 1 was taken to surgery for a laparoscopic left nephrectomy (removal of left kidney using small incisions and a camera). MD 1 performed the surgery. MD 1 did not have privileges to perform this surgery and had not been proctored to determine if he was competent to do the surgery. The hospital staff did not check to see if MD 1 had privileges to perform the surgery. There was no documentation of the investigation as to how these errors occurred on the root cause analysis. On 6/24/21, Medical Doctor (MD) 2 was notified by the pathologist that the specimen removed was Pt 1's spleen, not her kidney. On July 16/2021 a case review was completed to determine the root cause of the error (why the error happened).
During a concurrent interview and record review on 10/4/21 at 4:20 p.m. with the Director of Risk Management (DRM), the hospital document titled, "Event and Causal Factor Diagram" (undated) was reviewed. The DRM stated this document was a "Root Cause Analysis" (RCA). The DRM stated the RCA was conducted on 7/16/21 and provided the sign-in sheet for attendees dated 7/16/21. The document was a flow chart that started with Pt 1's arrival to the hospital on 6/4/21, and ending with pathology results that indicated the specimen received was a spleen. The document ended with "Root Cause: Dynamic abd [abdomen], w/multiple co morbidities making surgery/anatomy challenging to distinguish specific organs" The DRM stated the RCA was created prior to the group assembly and was not a product of that meeting. The DRM stated an "Action Plan" was developed separately, and the medical peer review was a completely separate process to determine any physician-specific concerns. The DRM could not identify an oversight person or process to bring all components of the review together.
During a concurrent interview and record review on 10/6/21 at 9:20 a.m. with the Director of Surgical Services (DSS), the hospital document titled, "Event and Causal Factor Diagram" (undated) was reviewed. The DSS stated she attended the Root Cause Analysis meeting on 7/16/21, but the document indicating the root cause was already filled out. The hospital document titled, "Action Plan #21-341449 (undated) was also reviewed. The DSS stated the Action Plan was developed after the RCA by the Risk Management department with her input. The Action Plan indicated " ...Problem Statement - Primary Finding - Difficult procedure with dynamic patient abdomen resulting in unexpected removal of spleen ..." and " ...Incidental Findings - non-contributory - Privilege Inquiry prior to scheduling surgery. MD with nephrectomy privilege-basic laparoscopic." The DSS stated that from her perspective, the root cause was that the scheduler and circulating nurse failed to check privileges to confirm that it was alright for MD 1 to perform the surgery.
During a concurrent interview and record review on 10/6/21 at 11:20 a.m., the Vice President of Quality (VPQ) stated the RCA form was created before the group got together on 7/16/21 and that the form "probably shouldn't be called an RCA."
During an interview on 10/6/21 with the Chairman of Surgery (CS), the CS stated the root cause of the error was that the surgeon was "ill-prepared" to complete the surgery.
During a document review of the facility document titled, "Performance Excellence Plan Fiscal Year 2021," the document indicated, "Attachment B - Performance Improvement Methods and Tools ...Table 2: Performance Improvement Methodology ... Lean Thinking, Plan-Do-Study-Act Cycle, DMAIC Six Sigma ... Table 3: Performance Improvement Tools ...5 Whys (Technique to identify problem root cause by iteratively asking "Why" ...Fishbone Diagram (Cause-and-effects diagram to organize potential contributors to a complex problem) Gemba Walks (Direct observations of work processes, where the work is occurring. Direct collaboration with staff to improve processes ..." None of the Performance Improvement Methods or tools were evident in the documents submitted by the VPQ.
During a document review of the facility policy titled "Adverse Event Reporting to the California Depoartment of Health Services," dated 07/28/2020, the document indicated, "...II. DEFINITIONS A. Adverse event includes any of the following:... 3. The wrong surgical procedure performed on a patient that is inconsistent with the documented informed consent for that patient..." and "... IV. PROCEDURE A. Investigation 3...b. It shall be the responsibility of Risk Management to coordinate the initial investigation and support the root cause analysis..."
During a review of the facility's policy and procedure titled "Sentinel Event & Unusual Occurrence," dated 7/15/2021, the document indicated, "...II DEFINITIONS a. Sentinel Event...7. Surgery or other invasive procedure performed at the wrong site, on the wrong patient, or that is the wrong (unintended) procedure for a patient..." IV. PROCEDURE...B. Investigation of Events...2. A thorough and credible Root Cause Analysis is completed on all sentinel events and unusual occurrences..."
2. On 6/6/21, Pt 2 underwent a surgical procedure, and a piece of guidewire was left in Pt 2 while the Anesthesiologist (physicians who monitor and care for patients who are administered anesthesia during surgeries) was inserting a central venous catheter (CVC-a catheter placed into a large vein to give fluids or medications). The incident was not reported to CDPH.
During a review of the facility's policy and procedure (P&P) titled, "Adverse Event Reporting to the California Department of Health Services," dated 7/2020, the P&P indicated, "To comply with the mandated reporting requirements of Health and Safety Code 1279.1 (b). To support the improvement of patient safety and quality improvement initiatives ... Adverse event includes any of the following: ...Retention of foreign object in a patient after surgery or other procedure ... It shall be the policy of Community Medical Centers (CMC) to report an adverse event, as define within Health Safety Code 1279.1, to the California Department of Public Health (CDPH) no later than five days after the event has been detected...It will be the responsibility of the Risk Manager to develop and submit the initial report to the CDPH, as well as serve as liaison with the agency during subsequent investigation process ..."
3. During a concurrent interview and record review on 10/8/21 at 10:30 a.m. with the Informatics Registered Nurse (IRN), Patient (Pt) 4's medical record was reviewed. The medical record indicated Pt 4 was admitted on 2/9/21 with a movement disorder affecting the left side of Pt 4's body causing uncontrolled movements of her left arm and leg. The medical record indicated Pt 4 arrived at the hospital by ambulance with an intravenous (IV-into a vein) line in place in her right arm which was removed on 2/10/21 at 11:59 a.m.
The record indicated from 2/10/21 at 11:59 a.m. until 2/13/21 at 10:30 a.m., Pt 4 had the following intravenous lines:
2/10/21 at 11:59 a.m., IV placed in Left hand, removed on 2/12/21 at 12:30 p.m. due to non-functional IV.
2/12/21 at 12:30 p.m., IV placed in anterior left proximal forearm; removed on 2/13/21 at 3 a.m. due to non-functional IV.
2/13/21 at 3 a.m., IV placed in anterior left; removed on 2/13/21 at 10:29 a.m. due to infiltration (infusion of fluid outside of the vein into the tissues).
2/13/21 at 3 a.m., IV placed in anterior left forearm; removed by Pt 4 on 2/13/21 at 10:30 a.m.
The medical record indicated Pt 4's left hand was swollen, red and warm on 2/12/21 at 8 p.m. The nursing note titled "Significant Event" dated 2/13/21 at 5:09 a.m., included a picture of Pt 4's swollen left hand with a visible previous IV site and indicated Pt 4's doctor had been notified and blood cultures were ordered. On 2/13/21 at 8:14 a.m., the nursing documentation indicated Pt 4 had a fever and blood cultures were obtained which were positive for bacteria. By 2/13/21 at 10 p.m., Pt 4's left arm was swollen, bruised and painful to touch. The medical record note titled "Significant Event" dated 2/13/21 at 10 p.m. included a picture of Pt 4's swollen and purple colored left arm and indicated "left arm post IV infiltration." The physician's note on 2/14/21 at 1:52 p.m. indicated Pt 4 was scheduled for surgery that day to evaluate her left arm. The note indicated Pt 4 had symptoms of an infection in her left arm and indicated, " ...suspect infiltration from an IV ..."
During a concurrent interview and record review on 10/11/21 at 10:15 a.m. with the Oncology unit Manager (OM), Patient 4's medical record was reviewed. The record indicated Pt 4 was hospitalized on the oncology unit from 2/11/21 through 2/14/21 and then transferred to surgery and then ICU. The OM stated she does not remember anything about the condition of Pt 4's arm and did not receive an incident report about Pt 4.
During a concurrent interview and record review on 10/12/21 at 3 p.m. with the Director of Risk Management (DRM), the DRM confirmed no one had submitted an incident report about Pt 4's arm or IV infiltrations while she was hospitalized from 2/9/21- 5/22/21. The DRM stated she did not know anything about Pt 4 until 10/4/21 so the risk management department had not finished the review of Pt 4's record. The DRM stated if an incident report had been submitted it would have prompted a review by risk management and nursing.
A review of the hospital's policy and procedure titled Incident Reporting Intranet System (IRIS), dated 12/10/18, indicated, " ...Purpose: to provide a mechanism for reporting and tracking unusual incidents related to the care of patients ...Incident: an unusual situation or occurrence at [name of hospital] ...which is inconsistent with a desired patient outcome ...any [name of hospital] employee, medical staff member, patient, independent contractor, or volunteer may initiate a report ... Responsibility: Patient Safety/Risk- review of all incidents submitted in IRIS ...Point of Service Management- review and follow up documentation for incidents involving assigned areas of accountability ..."
40644
Tag No.: A0338
Based on interviews and record review, the hospital failed to ensure the Medical Staff operated under approved Bylaws and was responsible for the quality of care provided to Patients when:
1.) Medical Doctor (MD) 1 did not submit an application and was not approved for advanced laparoscopic (a surgical technique in which several small incisions [cuts] are made, and tubes are inserted. A laparoscope [a tool with a light and camera] and other instruments used to cut and sew tissue are inserted through those tubes allowing the surgeon to perform the procedure without making a large incision) privileges and was permitted to perform a left nephrectomy (removal of kidney) on Patient (Pt) 1 on 6/17/21. The laparoscopic nephrectomy performed on Pt 1 was the first case of this type for MD 1 and he was not proctored in accordance with medical staff bylaws. Following the surgery, Pt 1 remained with the diseased left kidney and the quality of care was not ensured for Pt 1. (refer to A353)
The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality of healthcare in a safe and responsible manner.
Tag No.: A0353
Based on interviews and administrative document reviews, the facility failed to ensure the Medical Staff complied with its bylaws when Medical Doctor (MD) 1 did not submit an application and was not approved for advanced laparoscopic (a surgical technique in which several small incisions [cuts] are made, and tubes are inserted. A laparoscope [a tool with a light and camera] and other instruments used to cut and sew tissue are inserted through those tubes allowing the surgeon to perform the procedure without making a large incision) privileges and was permitted to perform a left nephrectomy (removal of kidney) on Patient (Pt) 1 on 6/17/21. The laparoscopic nephrectomy performed on Pt 1 was the first case of this type for MD 1 and he was not proctored in accordance with medical staff bylaws.
This resulted in MD 1 performing a surgery he was not privileged to perform. The left kidney was not removed as consented and instead the spleen was removed. Pt 1 remained with the diseased left kidney after surgery. These failures resulted in Pt 1 being vulnerable to the negative effects of a splenectomy such as infections and thromboembolic (irregular blood clotting) complications.
Findings:
A review of Pt 1's medical record indicated Pt.1 was a 54 year old female with history of left kidney disease. Pt 1's frequent bouts of left kidney disease had been complicated by left kidney stone formation which led to numerous left kidney infections which required hospitalizations and antibiotics to resolve. These infections severely and permanently damaged the left kidney and decreased its normal function significantly. An imaging study (CT scan) performed on 5/20/21 revealed her left kidney to be atrophic (smaller than normal). A nuclear medicine renal scan (test which measures the kidney's function) performed on 5/18/21 showed her left kidney function was markedly decreased (15%) from the expected normal. Pt 1 was seen by MD1 in the facility on 6/4/21 and counseled to undergo a left laparoscopic (a surgical technique in which several small incisions [cuts] are made, and tubes are inserted. A laparoscope [a tool with a light and camera] and other instruments used to cut and sew tissue are inserted through those tubes allowing the surgeon to perform the procedure without making a large incision) nephrectomy (removal of kidney) as a mean of alleviating her left kidney infections. Pt 1 signed a surgical consent form for a left laparoscopic nephrectomy to be performed by MD 1 and MD 2 on 6/17/21. The consent form indicated "laparoscopic left nephrectomy versus possible open conversion". At the time the consent was signed neither physician (MD 1 nor MD 2) had applied for or had been granted the advanced laparoscopic privilege. The consent stated the surgery would be changed from laparoscopic to conventional open surgery in the event any difficulties were encountered in the operating room (open surgery requires a 6 to 8 inch incision to open the abdomen for the operation). MD 1 was not fully prepared to perform the procedure on 6/17/21 as he had not familiarized himself with the CT scan. MD 1 did not switch to an open procedure as he encountered difficulty during the procedure.
During a concurrent interview and credential file review on 10/4/21 at 1:30 PM with Medical Staff Director (MSD), MSD stated MD 1 had began working in the facility as a locum tenens urologist in 11/20. MSD stated on 2/11/21 upon approval of the Board of Trustees. MD 1 was was granted Primary Privileges in Urology and Lasers as an Associate Medical Staff member. MSD stated on 3/11/21, upon the approval of the Board of Trustees of the facility, additional privileges were granted in the Department of Surgery at the facility as an Associate member of the Medical Staff. MSD stated MD 1 never requested advanced laparoscopic privileges during the application or appointment process, he was never assessed for competence for advanced laparoscopic privileges, and he was never granted the privilege for advanced laparoscopic/minimally invasive procedures. MSD stated MD 2 had never requested advanced laparoscopic privileges during his tenure as a Medical Staff member, he was never assessed for competence for advanced laparoscopic privileges, and he was never granted the privilege for advanced laparoscopic/minimally invasive procedures.
During an interview on 10/6/21 at 9:20 AM with Director Surgical Services (DSS), DSS stated she was made aware of the wrong organ removal surgery on 6/25/21 by the DRM. DSS stated she immediately contacted the Medical Director of Surgical Services (CS), the VP of Operations, and the VP of Nursing. She stated the facility started their investigation on 6/28/21 by interviewing staff. DSS stated from her perspective the root cause of the incident could be attributed to the fact that neither the scheduler or the circulating nurse checked MD1's privileges prior to his starting the case.
During an interview on 10/6/21 at 9:45 AM with Surgical Scheduling Manager (SSM), SSM stated there is a process for checking privileges before scheduling a surgery case. SSM stated the Physician's Assistant (PA) from MD 2's office had called and scheduled the operating room time for MD 1 and MD 2. SSM stated neither physician had the appropriate privileges to warrant the scheduling of an advanced laparoscopic procedure. SSM stated there was a failure to check the privileges for MD1 as well as MD2 before the case was scheduled. SSM stated the surgery scheduler should have checked the privileges of both physicians prior to scheduling the case, however, she failed to do so.
During an interview on 10/6/21 at 2:44 PM with Surgical Scheduler (SS), SS stated she had been in the position for 5 years. SS stated she was called by a Physicians Assistant (PAs are medical professionals who diagnose illness, develop and manage treatment plans, prescribe medications, and often serve as a patient ' s principal healthcare provider.) (in MD 2's office) and asked to schedule a block of time in the surgery suite for MD 2 and MD 1. SS stated she was led to believe MD 2 would be the primary surgeon with MD1 acting as the assistant. SS stated she was supposed to check the privileges for both physicians before scheduling the time, however, she simply forgot to do so. SS stated neither MD 1 or MD 2 had advanced laparoscopic privileges. SS stated had she checked the privileges the surgery would have never been scheduled.
During an interview on 10/5/21 at 3:20 PM with Circulating Nurse (a registered nurse who makes preparations for an operation and continually monitors the patient and staff during its course, who works in the operating room outside the sterile field in which the operation takes place, and who records the progress of the operation, accounts for the instruments, and handles specimens), CN stated she was a surgery circulator on 6/17/21 during the case with patient 1. CN stated she was supposed to check the privileges for MD 1, however, she simply forgot to do so. CN stated neither MD 1 or MD 2 had advanced laparoscopic privileges.
During an interview on 10/5/21 with Director of Quality (DQ), DQ stated he was the Director of Quality for the facility. DQ stated he had been involved in investigating the incident and had helped to develop the action plan which was put in place to prevent a reoccurrence. DQ stated Pt.1 did not receive quality care when she had the wrong organ removed.
During an interview on 10/6/21 at 4:45 p.m. with the Chief of Surgery (CS), CS stated he was the chairman of the surgery department and the Director of the operating room. CS stated he had been involved in reviewing the advanced laparoscopic case performed by MD1. CS stated MD1 and MD2 had been removed from the surgical schedule for a period of time as the case was being reviewed by the MEC and the AD Hoc committee. CS stated MD1 had not been granted the appropriate privileges to perform an advanced laparoscopic procedure because he had never requested the privilege. CS stated it was his expectation as the surgical chair that all the surgeons should be aware of their privileges. CS stated his expectation was that MD1 should have been adequately prepared to perform the case. CS stated in his opinion MD1 had lacked preparation for the procedure when the spleen was removed instead of the kidney. CS stated in his opinion MD 1 had not reviewed the CT scan prior to surgery. CS stated in his opinion MD1 had not familiarized himself with the appropriate anatomical landmarks as he performed the procedure. CS stated in his opinion MD1 had used poor judgement during the procedure in terms of managing the exposure of the surgical field and in failing to convert from a laparoscopic procedure to an open procedure as the case progressed. He stated MD 1's "hubris" had caused him to make judgement errors during the procedure. CS stated Pt. 1 did not receive quality care.
During an interview on 10/8/21 at 10:45 AM with both DQ and VPQ, VPQ stated systems had been put in place to educate staff regarding physician privileges. VPQ stated leadership had put a monitoring systems in place to ensure credentials were in fact being checked. VPQ stated the Pt. 1 did not receive quality care.
During an interview on 10/7/21 at 11:07 am with MDQ, MDQ stated MD1 and PA 1 were not willing to be interviewed by the survey team during the federal survey process.
During an interview on 10/7/21 at 10:45 am with MD2, MD2 stated he was present in the operating room with MD1 on two brief occasions during the course of the case on 6/17/21. MD2 stated he was there in case MD1 decided to convert to an open procedure in lieu of continuing with the advanced laparoscopic procedure. He stated he did recall MD1 making a comment about a lot of adhesions but otherwise the surgery seemed to be progressing smoothly. MD2 stated he did not have advanced laparoscopic privileges on 6/17/21. MD2 stated MD1 did not have advanced laparoscopic privileges on 6/17/21. MD2 stated he informed the patient the wrong organ had been removed after the pathology report was received about a week after surgery.
During an interview on 10/6/21 at 2:00 pm with MD 3, MD3 stated he was a pathologist (physician who deals with tissue examination and microscopic diagnosis). MD 3 said he had been asked to evaluate a microscopic slide from the organ that had been removed from Pt. 1 by MD1 on 6/17/21. MD3 stated he also evaluated the organ from which the slide had been made. MD3 stated both evaluations revealed the organ to be a spleen and not a kidney as it had been labeled when it was received in the pathology laboratory.
During an interview on 10/6/21 at 3:00 pm with MD 4, MD 4 stated he was a pathologist. MD4 said he had been asked to evaluate a microscopic slide from the organ that had been removed from Pt. 1 by MD1 on 6/17/21. MD4 stated the microscopic evaluation revealed the organ to be a spleen and not a kidney as it had been labeled when it was received in the pathology laboratory.
During an interview on 10/8/21 at 10:00 am with the Governing Body (GB), the GB stated they had been notified of the incident when the pathology report was released about a week after the incident. The GB stated their understanding of the what occurred was that the wrong organ had been surgically removed. The GB stated they were involved in the following up the incident and ensuring quality of care in the facility. The GB stated a performance improvement plan had been developed by the MEC for MD1. The GB stated the plan had been put in place for additional proctoring for MD1 as an means of restoring MD1's surgical privileges. The GB stated the proctoring plan for MD1 involved concurrent monitoring of his surgical cases including laparoscopic cases.
A review of the facility Medical Staff Credentials Policy (#24920) dated 12/10/20, indicated, "...III Policy D. Applicant's Responsibility and Burden of Producing Information 2. Applicant must ensure information contained on the application and other documents are accurate and complete. 6. Applicant shall have the burden of producing sufficient information of clinical and professional performance and current competence to permit an adequate evaluation of the applicant's qualifications and suitability for the clinical privileges and staff category requested, to resolve any reasonable doubts about the matters, and to satisfy any request for information..."
A review of the facility MEDICAL STAFF BYLAWS Volume I: Governance, Structure and Function of the Medical Staff dated 2/4/20, indicated, "...2.3 Responsibilities of Membership Each member of the Medical Staff and all Practitioners holding privileges must continuously comply with the provisions of these Bylaws, Medical Staff and [Facility] or [Facility] Hospital manuals, rules, regulations, and policies. Members must: a. Provide, to the satisfaction of the Medical Executive Committee, for continuous, adequate, and timely care to all patients for whom the Practitioner has responsibility; f. Seek appropriate consultation whenever necessary to promote adequate quality of care; Furthermore, each member of the Medical Staff by accepting Medical Staff appointment or privileges agrees: m. To abide by these bylaws and Medical Staff manuals, Medical Staff policies, rules and regulations, and [Facility] and [Facility] Hospital policies and procedures; q. To provide patient care and management only within the parameters of his/her professional competence, as reflected in the scope of clinical privileges granted the practitioner by the Board..."
A review of the facility MEDICAL STAFF BYLAWS Volume I: Governance, Structure and Function of the Medical Staff dated 2/4/20, the bylaws indicated, "... 2.4.2 Associate Staff b. PREROGATIVES:Appointees to this category may: 1) Exercise those privileges granted by the Board. c. RESPONSIBILITIES:Appointees to this category must: 3) Comply with all applicable [Facility] and Medical Staff Bylaws, rules, regulations, policies and procedures..."
A review of the facility MEDICAL STAFF BYLAWS Volume I: Governance, Structure and Function of the Medical Staff dated 2/4/20, the bylaws indicated, "...3.3 Medical Staff Credentials Policy Associated details elaborating the credentialing and privileging process and procedures can be found in the Medical Staff Credentials Policy that will be adopted and amended from time to time by the Medical Executive Committee..."
A review of Laparoscopic Renal Surgery for Benign Disease (Liao, J., Breda, A., and Schulam, P.) indicated, "...For left nephrectomy... The Gerota's fascia is incised near the lower pole to identify the ureter. The gonadal vein is identified at this time and left intact. The plane of dissection is lateral to the gonadal vein, which we do not routinely divide. Particularly on the left side , by staying lateral to the gonadal, unnecessary dissection of the lumbar vein(s) is obviated. The ureter and the lower pole are now elevated with a blunt instrument and the Gerotas fascia is swept off the the capsule. Alternatively, if significant inflammation and fibrosis are encountered, Gerota's fascia can be used as a plane of dissection and be swept free from the psoas muscle, as in radical nephrectomy. With the ureter elevated along with the lower pole of the kidney, the dissection marches towards the renal hilum. After identifying the renal vein a plane between the vein and artery is developed. With adequate elevation on the kidney, the endoscopic vascular stapler can be safely placed across the artery using the 12 mm port followed by the renal vein in a similar fashion..."
A review of Medical complications following splenectomy (R. Buzele, L. Barbier, A. Sauvanet, B. Fantin) indicated, "...Because splenectomy may be attended by infectious and thrombotic complications, the splenectomized patient requires careful monitoring in the early postoperative period as well as in medium and long-term follow-up. Patient education, antibiotic prophylaxis and regular updating of vaccinations are key elements of management. There are no specific recommendations for the prevention of thrombotic complications but special attention should be paid to the detection of thrombosis of the porto-mesenteric and caval venous systems, where the risk is increased, especially in cases of myeloproliferative disease or cirrhosis.
Tag No.: A0945
Based on interview and record review, the hospital failed to ensure surgical procedures were performed by a qualified and competent practitioner when MD 1 scheduled and performed a procedure without the privilege to do so. This failure resulted in the unintended removal of Patient 1's spleen instead of the left kidney as was intended and placed Pt 1 at risk of harm due to the need for another surgery to remove the left kidney and the potential negative effects of no longer having a spleen.
Findings:
A review of Pt 1's medical record indicated Pt 1 was scheduled for a laparoscopic left nephrectomy (removal of the left kidney) on 6/17/21 with MD 1. Review of the pathology report dated 6/24/21 of the surgical specimen submitted as "left kidney" indicated Pt 1's spleen had been removed instead of Pt 1's kidney.
During a concurrent observation and interview on 7/13/21 at 9:30 a.m. with Pt 1 in her hospital room, Pt 1 stated she was informed by MD 2 her spleen had been removed instead of her kidney about one week after the surgery.
During an interview on 10/5/21 at 3:20 p.m. with Circulating Nurse (CN) 1, CN 1 stated she did not check to see if MD 1 had privileges to do a laparoscopic nephrectomy. CN 1 stated, "I thought that was checked before [the start of surgery] but now I know I need to do it."
During an interview on 10/6/21 at 9:20 a.m., the Director of Surgical Services (DSS) stated having the surgical scheduler and the circulating nurse verify privileges wasn't new, and the changes that were put in place after their last survey should have caught this mistake.
During an interview on 10/6/21 at 9:45 a.m. with the surgical scheduling manager (SSM), the SSM stated there is a process for checking privileges before scheduling a surgery case. She stated neither MD 1 nor MD 2 had the appropriate privileges to allow the scheduling of an advanced laparoscopic procedure. She stated there was a failure to check the privileges for MD 1 as well as MD 2 before the case was scheduled. She stated the surgery scheduler should have checked the privileges of both physicians prior to scheduling the case.
During an interview on 10/6/21 at 2:44 p.m. with the Surgery Scheduler (SS), the SS stated she received a call to schedule the surgical case with MD 2 and was asked to add MD 1 to the case as well, and that he would be assisting. SS stated, "We are supposed to check privileges, but that didn't happen this time." The SS stated she made a mistake in not checking privileges.
During an interview on 10/6/21 at 4:55 p.m. with the Chairman of Surgery (CS), the CS stated, "Each surgeon should absolutely know his own privileges."
During a concurrent interview and record review on 10/7/21 at 9:50 a.m. with the Quality Management Coordinator (QMC), the document "Urology- Delineation of Privileges" form was reviewed. The QMC stated MD 1 had never requested or held advanced laparoscopic privileges and had not performed any laparoscopic procedures (basic or advanced) since he started at this hospital in 11/20 until this advanced procedure on 6/17/21. The QMC stated if he had been granted advanced laparoscopic procedure privileges he would still have been required to have his first three cases proctored by a surgeon privileged in advanced laparoscopic surgical procedures; the first case would be directly observed by the proctor in the operating room and the next two cases would be reviewed after the procedures are completed. Proctoring must be complete before the surgeon can perform the advanced laparoscopic procedures independently.
Review of the policy and procedure titled "OR-Scheduling a Surgical Case" dated 8/20/21, indicated, " ...Physicians may only schedule procedures for which they have privileges approved by Medical Affairs ...the person who receives the request to schedule a case will verify a surgeon's privileges to perform the specific procedure using the on-line privileging verification program-or direct verification with the Medical Affairs Office ..."