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Based on document reviews and interviews, the Governing Body failed to ensure that the Medical Staff followed the Medical Staff Bylaws for reviewing and documenting practitioner-specific quality and peer review data (A-0048) and failed to ensure that the Medical Staff's credentialing quality files contained peer review and periodic appraisals (A-0050).

Cross Reference:
§482.12(a)(4) Approve Medical Staff Bylaws
§482.12(a)(6) Ensure the Criteria for Selection

Findings:

The Governing Body is required to ensure that the Medical Staff follows approved medical staff bylaws. The Governing Body failed to ensure that the Medical Staff followed the Medical Staff Bylaws for reviewing and documenting practitioner-specific quality and peer review data. See A-0048 for details.

The Governing Body is required to ensure that the criteria for medical staff selection are individual character, competence, training, experience, and judgment. The Governing Body failed to ensure that the Medical Staff's credentialing quality files contained peer review and periodic appraisals. See A-0050 for details.

The cumulative effect of these deficient practices resulted in noncompliance with this Condition of Participation.

Based on document reviews and interviews, the Condition of Participation (COP) for the Medical Staff was not met as evidenced by the hospital's failure to ensure that the medical Staff operates under bylaws approved by the Governing Body.

Cross Reference:
§482.22(a)(1) Medical Staff Periodic Appraisals
§482.22(a)(2) Medical Staff Credentialing

Findings:

a. The Medical Staff must periodically conduct appraisals of its members. The hospital provided no evidence that medical staff appraisals are being conducted according to the process documented in the Medical Staff Bylaws. See A-0340 for details.

b. Provider candidates who have been recommended by the medical staff and who have been appointed by the Governing Body are subject to all Medical Staff Bylaws, Rules, and Regulations. The hospital failed to provide evidence of medical staff quality review as required in the Medical Staff credentialing process. See A-0341 for details.

The cumulative effects of these deficient practices, specifically the failure to provide documented evidence of meaningful case review as specified in the Medical Staff Bylaws for all but two (2) medical staff members in 2024 as well as the lack of documentation of peer review of Physician #1 cited as an example of the medical staff performing quality review, resulted in noncompliance with this Condition of Participation.

Based on document review and interviews, the hospital failed to follow all steps specified in the Medical Staff Bylaws for re-credentialing and approval of privileges for medical staff including sharing reviewed quality data with the providers.

Findings:

The hospital failed to provide documented evidence that the Medical Staff performs the following steps in the determination of privileges and reappointment:

- Reviews practitioner-specific quality data and performance improvement activities or case review;
- Shares this information with medical staff members at least annually;
- Reviews peer review, performance improvement, or quality assurance material prior to the process of re-credentialing and approval of privileges.
- Maintains this information in the Medical Center's credential file of the medical staff member.

The hospital failed to provide documented evidence that the Medical Staff conducts periodic appraisals of its members. There was no documented evidence that practitioner-specific quality data and performance improvement activities or case review described in the bylaws was being performed, or any peer review, performance improvement, or quality assurance material was reviewed by the Medical Staff prior to the process of re-credentialing and approval of privileges.

The St. Mary's Regional Medical Center Medical Staff, Bylaws, Rules & Regulations, amended and restated on 6/17/2024, state in part:

"7.2.2 Bases for Privileges Determinations. Requests for clinical privileges shall be evaluated based on the Practitioner's licensure, education, training, experience, demonstrated professional competence, judgment, physical and mental health status, references and other relevant information. The bases for privileges determinations to be made in connection with periodic reappointment or otherwise shall include, but not necessarily be limited to, the following:

7.2.2.1 results of practitioner-specific quality assessment and performance improvement activities,

7.2.2.2 review of the records of patients treated in the Medical Center or other healthcare facilities;

7.2.2.3 and review of the records of the Medical Staff which document the evaluation of the member's participation in the delivery of medical care.

This review may also include direct observation of care provided. This information shall be added to and maintained in the Medical Center's credential file established for a Medical Staff member or Allied Health Professional....

11.4.13 Provide a process which includes, at a minimum on a yearly basis, relevant documented provider-specific clinical performance improvement feedback to each member of the Medical Staff department who participates in patient care."


On 1/17/2025 at 2:10 PM, the Chief Medical Officer (CMO) was interviewed. When asked about peer review, the CMO acknowledged that there is no consistent process for peer review in individual departments, but there is a peer review committee that meets throughout the year to review flagged cases. The CMO also acknowledged that meetings are canceled when there are no cases to review. The CMO provided an example of a physician whose care was subjected to peer review (Physician #1). The survey team requested minutes of this peer review committee, but the hospital was only able to provide minutes of one (1) meeting in 2024 on 10/10/2024, with 2 cases discussed, neither related to Physician #1. A schedule of peer review committee meetings was provided to the survey team showing all meetings in 2024 were canceled except for the 10/10/2024 meeting and a 6/6/2024 meeting for which the hospital failed to provide minutes.

On 1/21/2025 at 11:15 AM, a follow-up interview with the CMO and the hospital President was conducted with further discussion of peer review. The CMO described the "first step" as a referral to the Department Chair for first review. The CMO stated that he also reviews cases reported to him. The CMO acknowledged again that many peer review meetings were canceled in 2024. When asked about medical staff quality review, the CMO mentioned Focused Professional Practice Evaluation (FPPE), Ongoing Professional Practice Evaluation (OPPE), National Surgical Quality Improvement Program (NSQIP) certification, and Det Norske Veritas (DNV) Hip & Joint certification. The CMO stated that peer reviews are part of credentialing process but admitted that documentation is "limited" to "email threads" or just direct communication. The CMO acknowledged "But I know if it is not documented, it did not happen."

On 1/22/2025 at 10:40 AM, the Chair of Psychiatry, who is also a member of the Medical Executive Committee and Peer Review Committees and who will be taking over as Interim CMO next month, was interviewed. She was not able to provide information on any more than the 2 peer review committee meetings that took place in 2024. She was not sure what quality/peer information goes into medical staff credentialing quality files and stated, "From my experience, if it is not documented, it did not happen."

The hospital failed to provide evidence of how quality data are used for credentialing and recredentialing or how the medical staff determines a pattern of concern with a medical staff member. On 1/22/2025 at approximately 2:30 PM, the hospital President asked one of the Quality staff to review Ongoing Professional Practice Evaluation (OPPE) data with the survey team. The Data Quality Coordinator provided an example of the Hospitalist OPPE data elements. She reported that these dashboards are updated monthly and put in a ShareFile with secure access to only the respective chief and the Chief Medical Officer (CMO). Staff confirmed at 2:40 PM that there is no evidence that the OPPE data are reviewed prior to reappointment. When asked if OPPE data are reviewed by the CMO at the Medical Executive Committee, the Medical Staff Coordinator assumed it was but could not confirm.

On 1/23/2025 at 8:50 AM, the Director of Quality and the Medical Staff Coordinator reviewed the credential file of Physician #1 mentioned by the CMO as having quality issues with the survey team. The Director of Quality stated that she had identified probable quality concerns with the care provided by Physician #1. There was, however, no evidence in the credentials quality file of Physician #1 that any case review was performed by the hospital medical staff which was confirmed by the Director of Quality.

On 1/23/2025 at 10:30 AM, the survey team reviewed 3 more credentialing files for medical staff reappointments with the Medical Staff Coordinator and Director of Quality. The survey team asked about any documentation of quality or case review of these practitioners. There was no documented evidence that quality data or case review of these practitioners was reviewed as part of the reappointment process.

There was no evidence in minutes of meetings labeled "Medical Executive Committee" or "Medical Executive Committee Peer Review" of any case review or quality review.

Based on document review and interviews, the hospital failed to provide documented evidence that the Medical Staff conducts periodic appraisals of its members. There was no documented evidence that practitioner-specific quality data and performance improvement activities or case review described in the bylaws was being performed or any peer review, performance improvement, or quality assurance material was reviewed by the Medical Staff prior to the process of re-credentialing and approval of privileges.

Findings:

The St. Mary's Regional Medical Center Medical Staff, Bylaws, Rules & Regulations, amended and restated on 6/17/2024, state in part:

"7.2.2 Bases for Privileges Determinations. Requests for clinical privileges shall be evaluated based on the Practitioner's licensure, education, training, experience, demonstrated professional competence, judgment, physical and mental health status, references and other relevant information. The bases for privileges determinations to be made in connection with periodic reappointment or otherwise shall include, but not necessarily be limited to, the following:

7.2.2.1 results of practitioner-specific quality assessment and performance improvement activities,

7.2.2.2 review of the records of patients treated in the Medical Center or other healthcare facilities;

7.2.2.3 and review of the records of the Medical Staff which document the evaluation of the member's participation in the delivery of medical care.

This review may also include direct observation of care provided. This information shall be added to and maintained in the Medical Center's credential file established for a Medical Staff member or Allied Health Professional ...

11.4.13 Provide a process which includes, at a minimum on a yearly basis, relevant documented provider-specific clinical performance improvement feedback to each member of the Medical Staff department who participates in patient care."

On 1/22/2025 at 12:55 PM, the Medical Staff Coordinator (an administrative position supporting the Medical Staff office) was interviewed along with the hospital President. The hospital maintains medical staff credential files online. The Medical Staff Coordinator stated that she has does not have access to individual medical staff member quality files. When the survey team asked to review peer review cases, the Medical Staff Coordinator was able to show an on-line list of cases which were reviewed by the Peer Review Committee. Four (4) cases were reviewed in 2024 for a medical staff with 188 active status members. Physician #1 was not among these four (4) peer reviews. In an interview on 1/27/2025 at 2:10 PM, the Chief Medical Officer (CMO) had mentioned Physician #1 having quality issues which led to a peer review.

There was no evidence of how quality data are used for credentialing and recredentialing or how the medical staff determines a pattern of concern with a medical staff member. At approximately 2:30 PM on 1/22/2025, the President asked one of the Quality staff to review Ongoing Professional Practice Evaluation (OPPE) data with the survey team. The Data Quality Coordinator provided an example of the Hospitalist OPPE data elements. She reported that these dashboards are updated monthly and put in a ShareFile with secure access to only the respective chief and the Chief Medical Officer (CMO). Staff confirmed at 2:40 PM that there is no evidence that the OPPE data are reviewed prior to reappointment. When asked if OPPE data are reviewed by the CMO at the Medical Executive Committee, the Medical Staff Coordinator assumed it was but could not confirm.

On 1/23/2025 at 8:50 AM, the Director of Quality and the Medical Staff Coordinator were interviewed. The credential file of Physician #1 mentioned by the CMO as having quality issues was reviewed. The Director of Quality stated that she had identified probable quality concerns with the care provided by Physician #1. There was, however, no evidence in the credentials quality file of Physician #1 that any case review was performed by the hospital medical staff which was confirmed by the Director of Quality.

On 1/23/2025 at 10:30 AM, the survey team reviewed 3 more credentialing files for medical staff reappointments with the Medical Staff Coordinator and Director of Quality. The survey team asked about any documentation of quality or case review of these practitioners. There was no documented evidence that quality data or case review of these practitioners was reviewed as part of the reappointment process.

There was no evidence in minutes of meetings labeled "Medical Executive Committee" or "Medical Executive Committee Peer Review" of any case review or quality review.

This deficient practice poses a risk to the health and safety of patients served by the hospital.

Based on document review and interviews, the hospital failed to provide documented evidence that the Medical Staff conducts periodic appraisals of its members. There was no documented evidence that practitioner-specific quality data and performance improvement activities or case review described in the bylaws was being performed or any peer review, performance improvement, or quality assurance material was reviewed by the Medical Staff prior to the process of re-credentialing and approval of privileges.

Findings:

The St. Mary's Regional Medical Center Medical Staff, Bylaws, Rules & Regulations, amended and restated on 6/17/2024, state in part:

"7.2.2 Bases for Privileges Determinations. Requests for clinical privileges shall be evaluated based on the Practitioner's licensure, education, training, experience, demonstrated professional competence, judgment, physical and mental health status, references and other relevant information. The bases for privileges determinations to be made in connection with periodic reappointment or otherwise shall include, but not necessarily be limited to, the following:

7.2.2.1 results of practitioner-specific quality assessment and performance improvement activities,

7.2.2.2 review of the records of patients treated in the Medical Center or other healthcare facilities;

7.2.2.3 and review of the records of the Medical Staff which document the evaluation of the member's participation in the delivery of medical care.

This review may also include direct observation of care provided. This information shall be added to and maintained in the Medical Center's credential file established for a Medical Staff member or Allied Health Professional....

11.4.13 Provide a process which includes, at a minimum on a yearly basis, relevant documented provider-specific clinical performance improvement feedback to each member of the Medical Staff department who participates in patient care."


On 1/17/2025 at 2:10 PM, the Chief Medical Officer (CMO) was interviewed. When asked about peer review, the CMO acknowledged that there is no consistent process in individual departments, but there is a peer review committee that meets throughout the year to review flagged cases. The CMO also acknowledged that meetings are canceled when there are no cases to review. The CMO provided an example of a physician whose care was subjected to peer review (Physician #1). The survey team requested minutes of this peer review committee, but the hospital was only able to provide minutes of one (1) meeting in 2024 on 10/10/2024, with 2 cases discussed, neither related to Physician #1. A schedule of peer review committee meetings was provided to the survey team showing all meetings in 2024 were canceled except for the 10/10/2024 meeting and a 6/6/2024 meeting for which the hospital failed to provide minutes.

On 1/21/2025 at 11:15 AM, a follow-up interview with the CMO and the hospital President was conducted with further discussion of peer review. The CMO described the "first step" as a referral to the Department Chair for first review. The CMO stated that he also reviews cases reported to him. The CMO acknowledged again that many peer review meetings were canceled in 2024. When asked about medical staff quality review, the CMO mentioned Focused Professional Practice Evaluation (FPPE), Ongoing Professional Practice Evaluation (OPPE), National Surgical Quality Improvement Program (NSQIP) certification, and Det Norske Veritas (DNV) Hip & Joint certification. The CMO stated that peer reviews are part of credentialing process but admitted that documentation is "limited" to "email threads" or just direct communication. The CMO acknowledged "But I know if it is not documented, it did not happen."

On 1/22/2025 at 10:40 AM, the Chair of Psychiatry, who is also a member of the Medical Executive Committee and Peer Review Committees and who will be taking over as Interim CMO next month, was interviewed. She was not able to provide information on any more than the 2 peer review committee meetings that took place in 2024. She was not sure what quality/peer information goes into medical staff credentialing quality files and stated, "From my experience, if it is not documented, it did not happen."

Based on record reviews and interviews, the hospital failed to provide documented evidence that the Medical Staff follows the process delineated in its bylaws regarding quality review of members in the reappointment process as well as demonstrating a process which includes, at a minimum on a yearly basis, relevant documented provider-specific clinical performance improvement feedback to medical staff members.


Findings:

The St. Mary's Regional Medical Center Medical Staff, Bylaws, Rules & Regulations, amended and restated on 6/17/2024, state in part:

"7.2.2 Bases for Privileges Determinations. Requests for clinical privileges shall be evaluated based on the Practitioner's licensure, education, training, experience, demonstrated professional
competence, judgment, physical and mental health status, references and other relevant information. The bases for privileges determinations to be made in connection with periodic
reappointment or otherwise shall include, but not necessarily be limited to, the following:

7.2.2.1 results of practitioner-specific quality assessment and performance improvement activities,

7.2.2.2 review of the records of patients treated in the Medical Center or other healthcare facilities;

7.2.2.3 and review of the records of the Medical Staff which document the evaluation of the member's participation in the delivery of medical care.

This review may also include direct observation of care provided. This information shall be added to and maintained in the Medical Center's credential file established for a Medical Staff member or Allied Health Professional...

11.4.13 Provide a process which includes, at a minimum on a yearly basis, relevant documented provider-specific clinical performance improvement feedback to each member of the Medical Staff department who participates in patient care."

On 1/22/2025 at 12:55 PM, the Medical Staff Coordinator was interviewed with the hospital President. The hospital maintains medical staff credential files online, and the Medical Staff Coordinator stated that she has does not have access to individual medical staff member quality files. When the survey team asked to review peer review cases, the Medical Staff Coordinator was able to show an on-line list of cases which were reviewed by the Peer Review Committee. Four (4) cases were reviewed in 2024 for a medical staff with 188 active status members. Physician #1 was not among these four (4) peer reviews.

There was no evidence of how quality data are used for credentialing and recredentialing or how the medical staff determines a pattern of concern with a medical staff member. At approximately 2:30 PM, the President asked one of the Quality staff to review OPPE data with the survey team. The Data Quality Coordinator provided an example of the Hospitalist OPPE data elements. She reported that these are updated monthly and put in a ShareFile with secure access to only the respective chief and CMO. Staff confirmed at 2:40 PM that there is no evidence that the OPPE data are reviewed at time of reappointment. When asked if OPPE data are reviewed by the CMO at the Medical Executive Committee, the Medical Staff Coordinator assumed it was but could not confirm.

On 1/23/2025 at 8:50 AM, the Director of Quality and the Medical Staff Coordinator were interviewed. The credential file of Physician #1 mentioned by the CMO as having quality issues was reviewed. The Director of Quality stated that she had identified probable quality concerns with the care provided by Physician #1. There was, however, no evidence in the credentials quality file of Physician #1 that any case review was performed by the hospital medical staff.

On 1/23/2025 at 10:30 AM, the survey team reviewed 3 more credentialing files for medical staff reappointments with the Medical Staff Coordinator and Director of Quality. The survey team asked about any documentation of quality or case review of these practitioners. There was no documented evidence that quality data or case review of these practitioners was reviewed as part of the reappointment process.

There was no evidence in minutes of meetings labeled "Medical Executive Committee" or "Medical Executive Committee Peer Review" of any case review or quality review.

This deficient practice poses a risk to the health and safety of patients served by the hospital.