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Based on policy review, document review, and staff interviews it was determined the Governing Body failed to ensure any of the 466 physicians and allied health professionals actively credentialed to the medical staff met the established criteria for competence, in compliance with facility policy and the Medical Staff Bylaws.

Findings included:

The policy titled, Focused (FPPE) and Ongoing (OPPE) Professional Practice Evaluation Plan, (no policy number), was approved by the Board of Trustees on 6/2018. The policy applied to all Licensed Independent Practitioners or Allied Health Professional who had delineated clinical privileges. The policy defined FPPE as a systematic process to ensure that there is sufficient information available to confirm the current competence of practitioners and the competence of those who have been granted privileges and/or were requesting new privileges. The policy defined OPPE as a summary of ongoing data collected for the purpose of assessing Licensed Independent Practitioners' and Allied Health Professionals' clinical competence. The policy included lists of criteria that would be evaluated for each practitioner. The policy indicated Quality Management would compile and analyze the data every six months.

The review of the Medical Staff Bylaws, last revised March 27, 2015 and most recently reviewed and approved March 2019 revealed the Qualifications for Membership were defined under Section 3A, page 5. The Bylaws indicated the requirements for privileges included documented professional experience, education, training, and demonstrated competence. The Bylaws indicated the evidence must be documented with sufficient adequacy to demonstrate to the medical staff and governing body that the physician would provide quality medical care to any patient for services provided in compliance with approved privileges. Section 3B, page 6 indicated no individual is automatically entitled to initial or continued membership on the medical staff or to the exercise of particular clinical privileges in the hospital merely because he is duly licensed to practice or because the individual has previously been a member of this medical staff.

The review of the list of actively credentialed practitioners and allied health professionals revealed a total of 466 members of the medical staff. 41 of the 466 were physicians with delineated privileges and Active status. 98 of the 466 were allied health professionals with delineated privileges whose status was Privileges Without Membership. 327 of the 466 were physicians with Courtesy, Consulting, or Associate status. The Bylaws indicated all categories of medical staff required evidence of competence as a qualification.

The Oxford Dictionary defines competence as, "The ability to do something successfully or efficiently". (https://en.oxforddictionaries.com/definition/competence)

The Webster Dictionary defines competence as, "the quality or state of being competent: such as the quality or state of having sufficient knowledge, judgment, skill, or strength". (https://www.merriam-webster.com/dictionary/competence)

The review of 14 credentialing files of physicians and allied health professionals (sample #A, B, C, D, E, F, G, H, I , J, K, L, M, and N) failed to reveal any evidence establishing the physicians' demonstrated competence for the privileges for which they were approved by the Governing Body. The files contained no evidence of any of the physicians' abilities to perform the services for which they were credentialed in a successful manner. The files contained no evidence that any of the 14 sampled physicians applied their knowledge, judgment, or skill in a manner that ensured quality care was provided to patients.

The review of 14 credentialing files of physicians and allied health professionals (sample #A, B, C, D, E, F, G, H, I , J, K, L, M, and N) failed to reveal any evidence FPPE or OPPE activities were conducted for any of the 14 sampled physicians in 2016, 2017, 2018 or 2019. All of the 14 sampled physician files included evidence the Medical Council recommended, and the Governing Body approved, the appointment or reappointment to the medical staff with privileges to provide patient care as requested by the candidate.

An interview was conducted with the Director of Physician Services on 3/26/19 at 2:00 p.m. The Director confirmed the finding FPPE and OPPE activities had not been conducted for any of the 14 sampled physicians since the fourth quarter of 2015. The Director indicated no evidence of the quality of care, or competence to provide quality medical care, was included in any of the materials provided to the Medical Council to review prior to recommending a physician to the Governing Body for approval of privileges. The Director indicated none of the 466 actively credentialed physicians and allied health professionals files included evidence of the quality of care, or the competence to provide quality medical care to patients in the facility.

An interview was conducted with the Assistant Vice President of Quality and Clinical Operations, West Florida Division on 3/29/19 at 12:25 p.m. She confirmed the finding none of the 466 actively credentialed physicians and allied health practitioners approved by the Governing Body included the review of evidence of competence to provide quality medical care to patients.

Based on policy review, document review, and staff interview it was determined the facility failed to ensure data related to physician quality of care was tracked, trended, analyzed and reported for purposes of improving patient outcomes and providing data to assist in the determination of physician competency.

Findings included:

The Quality Management Plan, revised 03/2019, indicated data metrics are analyzed for trends and process improvements (PI's) are put into place as identified. The plan indicated the Medical Staff were accountable for ensuring the ongoing program for performance improvement demonstrated patient safety and the quality of care provided to patients.

The policy titled, Focused (FPPE) and Ongoing (OPPE) Professional Practice Evaluation Plan, (no policy number), was approved by the Board of Trustees on 6/2018. The policy applied to all Licensed Independent Practitioners or Allied Health Professional who had delineated clinical privileges. The policy defined FPPE as a systematic process to ensure that there is sufficient information available to confirm the current competence of practitioners and the competence of those who have been granted privileges and/or were requesting new privileges. The policy defined OPPE as a summary of ongoing data collected for the purpose of assessing Licensed Independent Practitioners' and Allied Health Professionals' clinical competence. The policy included lists of criteria that would be evaluated for each practitioner. The policy indicated Quality Management would compile and analyze the data every six months.

The review of 14 credentialing files of physicians and allied health professionals (sample #A, B, C, D, E, F, G, H, I , J, K, L, M, and N) failed to reveal any evidence FPPE or OPPE activities were conducted for any of the 14 sampled physicians in 2016, 2017, 2018 or 2019. All of the 14 sampled physician files included evidence the Medical Council recommended, and the Governing Body approved, the appointment or reappointment to the medical staff with privileges to provide patient care as requested by the candidate without evidence of any of the physicians' or allied health providers' competence to provide quality medical care to patients.

An interview was conducted with the Director of Physician Services on 3/26/19 at 2:00 p.m. The Director confirmed the finding FPPE and OPPE activities had not been conducted for any of the 14 sampled physicians since the fourth quarter of 2015. The Director indicated no evidence of the quality of care, or competence to provide quality medical care, was included in any of the materials provided to the Medical Council to review prior to recommending a physician to the Governing Body for approval of privileges. The Director indicated none of the 466 actively credentialed physicians and allied health professionals files included evidence of the quality of care, or the competence to provide quality medical care to patients in the facility.

On 03/28/19 at 1:45 p.m., an interview was conducted with two Quality Coordinators and the Vice President of Quality and Safety. All interviewees confirmed the finding the facility was not tracking, trending, analyzing or reporting physician specific data for purposes of establishing the competence of the physician to provide quality patient care, or to identify problems or concerns for performance improvement related to the quality of medical services provided to patients.

An interview was conducted with the Assistant Vice President of Quality and Clinical Operations, West Florida Division on 3/29/19 at 12:25 p.m. She confirmed the finding the Quality Department ceased FPPE and OPPE data collection activities in the fourth quarter of 2015, indicating no data has been collected to track, trend, analyze or report the quality of care provided by any of the 466 currently credentialed physicians and allied health practitioners providing medical services to hospital patients.

Based on policy review, document review and staff interviews it was determined the facility failed to ensure 466 of the 466 actively credentialed physicians and allied health providers with privileges at the facility were in compliance with the Medical Staff bylaws requirement to include evidence of the physicians' demonstrated competence to provide quality medical care to patients.

Findings included:

1. It was determined the facility failed to conduct periodic appraisals of 466 of 466 members of the medical staff since 2015(Refer to A0340).

2. It was determined the facility failed to ensure the re-credentialing process included objective measures to establish the physician's demonstrated competence to perform the medical services for which privileges were approved for 466 of 466 actively credentialed physicians and allied health providers.(Refer to A0341).

The facility was not in compliance with 42 CFR 482.22, the Condition of Participation for Medical Staff, requirements for hospitals. These failures resulted in a finding of ongoing Immediate Jeopardy, beginning on 3/14/2019, creating a situation that is likely to result in serious injury, harm, impairment, or death to patients and requires immediate corrective action on the part of the facility.

Based on policy review, document review and staff interview it was determined the facility failed to perform periodic appraisals of provider performance in compliance with facility policies for 466 of the 466 actively credentialed physicians and allied health professionals privileged to provide medical care and services in the facility. These failures resulted in a finding of ongoing Immediate Jeopardy, beginning on 3/14/2019, creating a situation that is likely to result in serious injury, harm, impairment, or death to patients and requires immediate corrective action on the part of the facility.

Findings included:

The policy titled, Focused (FPPE) and Ongoing (OPPE) Professional Practice Evaluation Plan, (no policy number), was approved by the Board of Trustees on 6/2018. The policy applied to all Licensed Independent Practitioners or Allied Health Professionals who had delineated clinical privileges. The policy defined FPPE as a systematic process to ensure that there is sufficient information available to confirm the current competence of practitioners and the competence of those who have been granted privileges and/or were requesting new privileges. The policy defined OPPE as a summary of ongoing data collected for the purpose of assessing Licensed Independent Practitioners' and Allied Health Professionals' clinical competence. The policy included lists of criteria that would be evaluated for each practitioner. The policy indicated Quality Management would compile and analyze the data every six months.

The review of the list of actively credentialed practitioners and allied health professionals revealed a total of 466 members of the medical staff. 41 of the 466 were physicians with delineated privileges and Active status. 98 of the 466 were allied health professionals with delineated privileges whose status was Privileges Without Membership. 327 of the 466 were physicians with Courtesy, Consulting, or Associate status. The Bylaws indicated all categories of medical staff required evidence of competence as a qualification of membership.

The review of 14 credentialing files of physicians and allied health professionals (sample #A, B, C, D, E, F, G, H, I , J, K, L, M, and N) failed to reveal any evidence FPPE or OPPE activities were conducted for any of the 14 sampled physicians in 2016, 2017, 2018 or 2019. All of the 14 sampled physician files included evidence the Medical Council recommended, and the Governing Body approved, the appointment or reappointment to the medical staff with privileges to provide patient care as requested by the candidate.

An interview was conducted with the Director of Physician Services on 3/26/19 at 2:00 p.m. The Director confirmed the finding FPPE and OPPE activities had not been conducted for any of the 14 sampled physicians since the fourth quarter of 2015. The Director indicated no evidence of the quality of care, or competence to provide quality medical care, was included in any of the materials provided to the Medical Council to review prior to recommending a physician to the Governing Body for approval of privileges. The Director indicated none of the 466 actively credentialed physicians and allied health professionals files included periodic FPPE or OPPE performance appraisals since 2015.

An interview was conducted with the Assistant Vice President of Quality and Clinical Operations, West Florida Division on 3/29/19 at 12:25 p.m. She confirmed the finding none of the 466 actively credentialed physicians and allied health practitioners approved by the Governing Body were periodically appraised in compliance with facility policies and Federal regulations.

Based on document review, policy review, medical record review, and staff interviews it was determined the facility failed to ensure the Medical Staff enforced the Bylaws requirement for physicians and allied health providers to have demonstrated competence of their ability to provide quality medical care to patients for 466 of 466 physicians and allied health care providers. These failures resulted in a finding of ongoing Immediate Jeopardy, beginning on 3/14/2019, creating a situation that is likely to result in serious injury, harm, impairment, or death to patients and requires immediate corrective action on the part of the facility.

Findings included:

The History and Physical dated 3/11/19 indicated Patient #4 was scheduled to undergo elective (non-emergency) laparoscopic gastric sleeve surgery for treatment of morbid obesity by Physician M. The History and Physical indicated Patient #4 was otherwise healthy. The patient had no history of high blood pressure, diabetes, heart disease, respiratory disease or other chronic illnesses. The Pre-operative Assessment indicated Patient #4 was admitted on 3/12/19 at 8:18 a.m. The untitled form documenting cardiopulmonary resuscitation documented Patient #4 died on 3/14/19 at 8:48 p.m.

The OR (Operating Room) Record documented Patient #4 entered the OR at 9:50 a.m. and was ready for the procedure at 10:20 a.m. The operation began at 11:40 a.m. Patient #4 left the OR at 5:33 p.m. and was transported directly to the Intensive Care Unit in critical condition, indicating Patient #4's surgical procedure took just under six hours to complete.

The Operative Report dated 3/12/19 and signed by Physician M indicated Patient #4 suffered an estimated 5,000 cc (cubic centimeter) blood loss (normal adult circulating blood volume is approximately 6,000 cc) during the surgery as a result of the puncture or laceration of the mesenteric artery early in the procedure. The record indicated Patient #4 received eight units of blood, one unit of fresh frozen plasma and large volumes of intravenous fluid to treat the hemorrhage. The operative report did not provide any description of the size, length, or nature of the damage to the mesenteric artery. The operative report indicated the bleeding was not controlled by suturing. Physician M documented he applied a fibrin product used to control bleeding. After observing the site for 10 minutes, Physician M proceeded to perform the originally scheduled elective procedure and close the initial incisions. Patient #4 had a significant drop in blood pressure at that time. Physician M re-opened the incision to find bleeding again at the previous site. He documented he performed additional suturing of the artery, and used three additional topical products intended to facilitate blood clotting and control bleeding. After observing the site for 15 minutes, Physician M again sutured the main incision and documented Patient #4 was transferred to intensive care in critical condition.

The Operative Report dated 3/13/19 at 4:03 a.m., and signed by Physician M, indicated Patient #4 was returned to the OR for a third attempt at controlling the bleeding from the mesenteric artery. The report described Physician M finding "a large amount" of blood in the patient's abdomen. The operative report did not include the estimated quantity of blood loss. Physician M documented suturing "one of the mesenteric arteries" and applying three different topical products intended to promote clotting and control bleeding. Patient #4 was returned to the Intensive Care Unit in critical condition following the surgery.

The Consultation report dated 3/14/19 was signed by Physician H. The report indicated Physician M requested Physician H to provide a second opinion. The report indicated Physician H determined Patient #4 was experiencing multisystem organ failure including renal, respiratory and liver failure as a result of shock due to blood loss. Physician H noted there was blood in the abdominal cavity seen on CT scan performed on 3/14/19 at 9:47 a.m., but no sign of active bleeding. Physician H documented he did not think there was any need to consider additional surgery.

The review of the credentialing file for physician M revealed he was reappointed to the medical staff with privileges as he requested in General and Laparoscopic Surgery, Gynecologic Surgery, and Vascular Surgery on 4/1/2013, 4/1/2015, and most recently on 4/1/2017 through 3/31/2019. The file failed to reveal any evidence of the demonstrated competence of Physician M to perform the services and procedures for which he had been approved for privileges. There were no mortality or morbidity statistics, or any information related to the quality of the medical care Physician M provided to patients. The most recent OPPE appraisal had been done in 2015. The National Provider Data Bank (NPDB) report dated 11/29/2018 included in the credentialing file revealed Physician M had been named in 16 malpractice suits between 2000 and 2018. Six of the 16 malpractice actions involved the death of a patient.

The review of the credentialing file for Physician H for the previous credentialing period of 4/1/17 through 5/31/19 revealed Physician H was approved for privileges in General Surgery and Vascular Surgery. The review of the established criteria for privileges in Vascular Surgery included a requirement to perform a minimum of 20 procedures in the previous two year period and complete 10 hours of continuing education in the specialty. A hand-written unsigned note dated 4/19(no year) was affixed to the Department Review and Committee Approval form. The note indicated Physician H was requesting approval for privileges in Vascular Surgery although he had not met the criteria. The form was signed by the Medical Staff Department Chair on 5/1/17 attesting the reviewing physician had reviewed the re-credentialing information and recommended approval of privileges as requested. The file included documentation of the approval of the privileges by the Governing Body effective 4/1/17. The file failed to reveal any evidence of the demonstrated competence of Physician H to perform the services and procedures for which he had been approved for privileges. There were no mortality or morbidity statistics, or any information related to the quality of the medical care Physician H provided to patients. The most recent OPPE appraisal had been done in 2015.

The review of the Medical Staff Bylaws, revised March 27, 2015 and most recently reviewed and approved March 2019 revealed the Qualifications for Membership were defined under Section 3A, page 5. The Bylaws indicated only physicians, dentists and podiatrists who could document their background, professional experience, education, training, and demonstrated competence with sufficient adequacy to demonstrate to the medical staff and governing body that any patient treated by them in the facility would be qualified for membership on the medical staff. Section 3B, page 6 indicated no individual is automatically entitled to initial or continued membership on the medical staff or to the exercise of particular clinical privileges in the hospital merely because he is duly licensed to practice or because the individual has previously been a member of this medical staff.

The policy titled, Focused (FPPE) and Ongoing (OPPE) Professional Practice Evaluation Plan, (no policy number), was approved by the Board of Trustees on 6/2018. The policy applied to all Licensed Independent Practitioners or Allied Health Professional who had delineated clinical privileges. The policy defined FPPE as a systematic process to ensure that there is sufficient information available to confirm the current competence of practitioners and the competence of those who have been granted privileges and/or were requesting new privileges. The policy defined OPPE as a summary of ongoing data collected for the purpose of assessing Licensed Independent Practitioners' and Allied Health Professionals' clinical competence. The policy included lists of physician performance criteria that would be evaluated for each practitioner. The policy indicated Quality Management would compile and analyze the data every six months.

The review of the list of actively credentialed practitioners and allied health professionals revealed a total of 466 members of the medical staff. 41 of the 466 were physicians with delineated privileges and Active status. 98 of the 466 were allied health professionals with delineated privileges whose status was Privileges Without Membership. 327 of the 466 were physicians with Courtesy, Consulting, or Associate status. The Bylaws indicated all categories of medical staff required evidence of competence as a qualification.

The Oxford Dictionary defines competence as, "The ability to do something successfully or efficiently". (https://en.oxforddictionaries.com/definition/competence)

The Webster Dictionary defines competence as, "the quality or state of being competent: such as the quality or state of having sufficient knowledge, judgment, skill, or strength". (https://www.merriam-webster.com/dictionary/competence)

The review of 14 credentialing files of physicians and allied health professionals (sample #A, B, C, D, E, F, G, H, I , J, K, L, M, and N) failed to reveal any evidence establishing the physicians' demonstrated competence for the privileges for which they were approved by the Governing Body. The files contained no evidence of any of the physicians' abilities to perform the services for which they were credentialed in a successful manner. The files contained no evidence any of the 14 sampled physicians applied their knowledge, judgment, or skill in a manner that ensured quality care was provided to patients.

The review of 14 credentialing files of physicians and allied health professionals (sample #A, B, C, D, E, F, G, H, I , J, K, L, M, and N) failed to reveal any evidence FPPE or OPPE activities were conducted for any of the 14 sampled physicians in 2016, 2017, 2018 or 2019. All of the 14 sampled physician files included evidence the Medical Council recommended, and the Governing Body approved, the appointment or reappointment to the medical staff with privileges to provide patient care as requested by the candidate.

An interview was conducted with the Director of Physician Services on 3/26/19 at 2:00 p.m. The Director confirmed the finding FPPE and OPPE activities had not been conducted for any of the 14 sampled physicians since the fourth quarter of 2015. The Director indicated no evidence of the quality of care, or competence to provide quality medical care, was included in any of the materials provided to the Medical Council to review prior to recommending a physician to the Governing Body for approval of privileges. The Director indicated none of the 466 actively credentialed physicians and allied health professionals files included evidence of the quality of care, or the competence to provide quality medical care to patients in the facility. She confirmed the finding Physician H was approved by the Medical Staff and the Governing Body for privileges in Vascular Surgery despite failing to meet the established criteria.

An interview was conducted with the Assistant Vice President of Quality and Clinical Operations, West Florida Division on 3/29/19 at 12:25 p.m. She confirmed the finding none of the 466 actively credentialed physicians and allied health practitioners approved by the Governing Body included the review of evidence of competence to provide quality medical care to patients.