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BARNES JEWISH HOSPITAL ONE BARNES-JEWISH HOSPITAL PLAZA SAINT LOUIS, MO 63110 June 20, 2019
VIOLATION: GOVERNING BODY Tag No: A0043
Based on interview and record review the facility's governing body failed to ensure adequate oversight of the medical staff appraisal and reappointment process when:

- Be ultimately responsible for the review and decision-making process for medical staff reappointment and appraisal process for two (Staffs C and M) of nine physicians' files reviewed.
- Ensure committees/staff responsible for gathering medical staff reappointment and/or appraisal materials are adequately doing so.
- Follow their policy for timely, completed, and pertinent ongoing professional practice evaluation (OPPE, tool that medical staff can use to determine if care provided by a practitioner is below an acceptable level) for two (Staffs C and M) of nine physicians' files reviewed.
- Gather and store performance/practice data in the electronic data base so it would be easily retrievable for review.
- The governing body minutes did not show active review of medical staff re-appointment application and supporting documentation.

The severity and cumulative effect of these systemic practices resulted in the facility being out of compliance with 42 CFR 482.12 Condition of Participation: Governing Body and resulted in the facility's failure to ensure quality health care and safety.

The facility census was 1030.
VIOLATION: MEDICAL STAFF - SELECTION CRITERIA Tag No: A0050
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview, medical staff re-appointment/appraisal reviews, policy review, and Medical Staff Bylaw review, it showed the facility's governing body failed to:
- Be ultimately responsible for the review and decision-making process for medical staff re-appointment and appraisal process for two (Staffs C and M) of nine physicians' files reviewed.
- Ensure committees/staff responsible for gathering medical staff re-appointment and/or appraisal materials are adequately doing so.
- Follow their policy for timely, completed, and pertinent ongoing professional practice evaluation (OPPE, tool that medical staff can use to determine if care provided by a practitioner is below an acceptable level) for two staff (C and M) of nine physicians' files reviewed.
- Gather and store performance/practice data in the electronic data base so it would be easily retrievable for review.
This had the potential to effect all patients by way of allowing a physician to provide unsafe, poor quality care because the physician's overall, current care had not been thoroughly evaluated. The facility census was 1030.

Findings included:

1. Review of the facility's document titled, "Hospital ByLaws of the Medical and Dental Staff," dated 09/2018, showed:
- The Board shall have authority to render initial appointment and reappointment to applicants eligible.
- The Board has sole responsibility to make any final decisions respecting appointments.
- Each re-appointment shall be based upon the results of the OPPE, or focused periodic professional evaluation (FPPE, a more focused OPPE when concerns arise, such as medical/surgical errors, deaths and/or lawsuits).
- If sufficient Practitioner-specific quality data is not available from the hospital's routine review functions, peer references may be required.

Review of the facility's policy titled, "Ongoing Professional Practice Evaluation," dated 01/30/18, showed:
- The OPPE information consists of performance data driven sources, such as length of stay (LOS, data used by hospitals to increase efficiency based on the number of days a patient remains in the hospital), mortality (the number of deaths in a given place or time), re-admissions within 30 days, volume of inpatients, volume of outpatients, inpatient procedure volume and outpatient procedure volume are factored into the decision to maintain privileges (authorized specific scope of practice for patient care), to revise privileges or to revoke a privilege prior to or at the time of renewal.
- Department and individual practitioner data is updated and posted at least quarterly in an electronic format.
- The evaluation of data occurs on a continuous basis, more frequent than annually and at a minimum of three times within the two year appointment period.
- Data reviewed and recommendations are documented and maintained in the individual practitioner's quality file.

Review of the facility's policy titled, "Department of Obstetrics and Gynecology Ongoing Professional Practice Evaluation," dated 02/2010, showed:
- A review of each privileged practitioner will be conducted at a minimum of every eight months and prior to re-appointment to evaluate performance.
- Types of performance data reviewed specific to Obstetrics and Gynecology are maternal mortality (death of a women in the stages of labor, delivery or immediate post-delivery), unplanned post-delivery return to delivery or surgery,[DIAGNOSES REDACTED] (a condition where a patient's blood pressure is high and she would be susceptible to increased electrical activity in the brain), operative mortality (death while in surgery or day of surgery), unplanned removal or injury while in surgery and discrepancy between pre-op and post-op diagnosis.
- The process is employed consistently for all members of the department without exception.
- Reports with individual physician practices would be sent to Medical Staff Services and stored in the practitioner's credentialing file.

Review of the facility's policy titled, "Focused Professional Practice Evaluation, "dated 01/2018, showed:
- Used to evaluate a practitioner when concerns arise with regards to their ability to provide safe, high quality patient care.
- For issues that concern safe, high quality patient care the organized medical staff, through approval of the Medical Staff Bylaws, develops criteria to evaluate the performance of practitioners when issues that have affected the provision of safe, high quality patient care are identified.
- Each department/division identifies performance criteria which would warrant a period to monitor performance.
- The method to establish a plan to monitor a practitioner would be defined by each department/division and would be specific to the provider and practice issue reviewed.

Review of the medical staff file for Staff C, Physician, showed that recredentialing paperwork submitted by, or on behalf of, Staff C, included the following:
- An email from Staff C addressed to the Medical Staff Services Coordinator, dated 05/02/19 at 4:04 PM, showed that Staff C verified his home address in Pasadena California (over 1800 miles away).
- A letter dated 05/03/19 from Barnes Jewish Hospital addressed to Staff C, which stated that the hospital's standard was to look at performance data for all practitioners with clinical privileges through OPPE, rather than just at the two year reappointment, and that Barnes Jewish Hospital had little or no inpatient clinical activity for Staff C, which made it difficult to assess clinical competencies. The letter requested specifically the completion of the Primary Institution Verification of Clinical Activity/Competence and the Physician Core Competency forms, filled out by "your primary facility Chief" and returned.
- An email dated 05/03/19 from Medical Staff Services and addressed to Staff C, requested him to have his "chief at your primary facility complete" a primary verification letter.
- Staff Cs documented practice information included his "primary practice" location in St. Louis, Missouri, specifically, the address to a local clinic (that provides abortions [surgical pregnancy termination]).
- A form titled, "Primary Institution Verification of Clinical Activity/Competence," was signed by a Professor and Chair of Obstetrics and Gynecology (OB/GYN, specialized care pertaining to pregnancy and the reproductive system of women), from a hospital in the state of California on 05/02/19, as part of the reappointment process for Barnes Jewish Hospital.
- His initial appointment to the California hospital medical staff was in January 2019 (approximately four months prior to the day the primary verification form was signed).
- During that time, he had 13 admissions, performed 12 procedures and had two consultations.
- Portions of the primary verification form, which included key metrics used to justify clinical activity and competence were left blank, including mortality (deaths) rates, length of inpatient stay, related readmissions, surgical site infection rates, patient satisfaction results and the privileges that the physician held at the California hospital.
- An email dated 05/09/19, from Barnes Jewish Medical Staff Services to Staff C, explained that the Primary Institution Verification was not complete, and directed him to have the form completed and returned.
- There was no indication that the form was completed and returned.
- Staff C's reappointment profile indicated that he had pending litigation (taking legal action against) related to an occurrence on 05/26/18, when a pregnancy termination was incomplete, and the patient was still pregnant approximately one month later. A second procedure was performed, and the patient was later hospitalized with an infection.
- He was recommended for reappointment to Barnes Jewish medical staff on 06/05/19, by Staff E, Interim Chair for OB/GYN.
- The dates between his original appointment on 07/20/17 and his first appraisal on 09/17/18 were 14 months apart.
- The next review had not been completed as of 06/20/19 which placed it at nine months since his last appraisal.

During an interview on 06/20/19 at 9:00 AM, Staff E, Interim Chair of OB/GYN, stated that:
- He had reviewed the re-appointment packet for Staff C, and did not identify any concerns.
- He assumed any blank questions on the verification form meant there was no data available.
- He knew Staff C, worked at a clinic outside the facility.
- He did not call the director of the local clinic (primary practice) to request feedback.
- He did not call the Medical Director of Staff C's employer in California to request feedback.
- He did not see any OPPE or FPPE regarding Staff C.
- He was not aware of the pending litigation.
Even though the criteria for re-appointment had not been met, Staff C signed the authorization for re-appointment. This authorization allowed the request for reappointment to go potentially unchallenged to the board for approval.

During an interview on 06/20/19 at 2:30 PM, Staff U, Board Member, stated that:
- The department chief and affiliated school of medicine approved the re-appointment packet before it came to the board.
- If there were concerns identified, they could be categorized by levels (I-III, with III being the most serious) before it came before the board. These levels flag the potential need for further investigation/question.
- He was currently not engaged in the appraisal process.

Review of the facility's policy titled, "Department of Anesthesiology Ongoing Professional Practice Evaluation," dated 02/2010, showed:
- Individual physician practice data is reviewed at least every eight months and prior to re-appointment.
- Types of data reviewed specific to Anesthesia are intra-operative and non-operative volume, antibiotic delivery, patient temperature upon arrival to Post Anesthesia Care Unit (PACU), and peer review results if any.
- The process is employed consistently for all members of the department without exception.
- Departmental quality data report is provided to the Division and Department Chief.
- Reports with individual physician practices would be sent to Medical Staff Services and stored in the individual credentialing file.

Review of the credentialing file, on 06/20/19, for Staff M, Physician, showed:
- His original appointment was on 10/09/17 and his last appraisal on 08/13/18, or nine months prior.
- He did not have any performance data in the electronic data base.
- He did not have any appraisal information or demonstrated professional competencies documented in his credentialing file.
- Staff failed to store pertinent, individualized performance/practice data in the electronic data base so it would be easily retrievable for review.

The Governing Body failed to review re-appointment process packet contents and oversee the appraisal process carefully to ensure pertinence, inclusion of quality/safety data, completeness and/or need to request further information.
VIOLATION: MEDICAL STAFF Tag No: A0338
Based on interview, record review and policy review the facility failed to ensure the Medical Staff conducted periodic appraisals (evaluation of performance) and re-appraisals with demonstrated competencies (specific sets of skills and behaviors needed to perform a specific job) for physicians when:
- An incomplete facility reappointment (the process used to re-evaluate a practitioner's current competency after they have been appointed to the medical staff) worksheet for Staff C, Physician was completed and signed by Staff E, Physician and Department Chief
- Although the form titled, "Verification of Clinical Activity/Competence" was not completed for Staff C, Physician, for his reappointment it was sent to the Credentials Committee and approved.
- The physician appraisal process was not completed within the timeframe delineated in the facility's policy.
- Only data driven sources, such as length of stay (LOS, data used by hospitals to increase efficiency based on the number of days a patient remains in the hospital), mortality (the number of deaths in a given place or time), re-admissions within 30 days, volume of inpatients, volume of outpatients, inpatient procedure volume and outpatient procedure volume, were presented for review.

These failures created an unsafe environment and had the potential to place all patients admitted to the facility at risk for their safety. The facility census was 1030.

The severity and cumulative effect of these failures resulted in the facility being out of compliance with 42 CFR 482.22 Condition of Participation: Medical Staff.
VIOLATION: MEDICAL STAFF PERIODIC APPRAISALS Tag No: A0340
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on interview, record review and policy review the facility failed to ensure the Medical Staff conducted periodic appraisals (evaluation of performance) and re-appraisals with demonstrated professional competencies (specific sets of skills and behaviors needed to perform a specific job), within the timeframe outlined in the facility policy, and had complete documentation for two Staff Physicians (C and M) of nine physician credentialing files (files used in the process to verify qualifications, and ensure current competence) reviewed. This had the potential to effect all patients by way of allowing a physician to provide unsafe, poor quality care because the physician's overall, current care had not been thoroughly and/or timely evaluated. One of these unapprised physicians (Staff C) performed an failed abortion procedure on one patient (Patient #4) resulting in the need for two additional procedures and hospitalization . The facility census was 1030.

Findings included:

1. Review of the facility's policy titled, "Ongoing Professional Practice Evaluation," dated 01/30/18, showed:
- The ongoing professional practice evaluation (OPPE, tools that the medical staff can use determine if care provided by a practitioner is below an acceptable level) information consists of performance data driven sources, such as length of stay (LOS, data used by hospitals to increase efficiency based on the number of days a patient remains in the hospital), mortality (the number of deaths in a given place or time), re-admissions within 30 days, volume of inpatients, volume of outpatients, inpatient procedure volume and outpatient procedure volume are factored into the decision to maintain privileges (authorized specific scope of practice for patient care), to revise privileges or to revoke a privilege prior to or at the time of renewal.
- Department and individual practitioner data is updated and posted at least quarterly in an electronic format.
- The evaluation of data occurs on a continuous basis, more frequent than annually and at a minimum of three times within the two year appointment period.
- Data reviewed and recommendations are documented and maintained in the individual practitioner's quality file.

Review of the facility's policy titled, "Focused Professional Practice Evaluation [FPPE]," dated 01/2018, showed:
- Used to evaluate a practitioner when concerns arise with regards to their ability to provide safe, high quality patient care.
- For issues that concerned safe, high quality patient care the organized medical staff, through approval of the Medical Staff Bylaws, develops criteria to evaluate the performance of practitioners when issues that have affected the provision of safe, high quality patient care are identified.
- Each department/division identifies performance criteria which would warrant a period to monitor performance.
- The method to establish a plan to monitor a practitioner would be defined by each department/division and would be specific to the provider and practice issue reviewed.

Review of the facility's policy titled, "Department of Obstetrics and Gynecology [OB/GYN, specialized care pertaining to pregnancy and the reproductive system of women] Ongoing Professional Practice Evaluation," dated 02/2010, showed:
- A review of each privileged practitioner will be conducted at a minimum of every eight months and prior to re-appointment to evaluate performance.
- Types of performance data reviewed specific to OB/GYN are maternal mortality (death of a women in the stages of labor, delivery or immediate post-delivery, unplanned post-delivery return to delivery or surgery,[DIAGNOSES REDACTED] (a condition where a patient's blood pressure is high and she would be susceptible to increased electrical activity in the brain), operative mortality (death while in surgery or day of surgery), unplanned removal or injury while in surgery and discrepancy between pre-op and post-op diagnosis.
- The process is employed consistently for all members of the department without exception.
- Reports with individual physician practices would be sent to Medical Staff Services and stored in the practitioner's credentialing file.

Review of the facility's policy titled, "Department of Obstetrics and Gynecology Focused Professional Practice Evaluation," dated 02/2010, showed:
- The department review committee refers all issues identified in the review process that would warrant further review of a practitioner's performance to the Department Chair.
- Type of monitors used would be a review of all cases against specific criteria, medical record review and discussion with the practitioner.
- Triggers for a focused review are maternal mortality, unplanned post-delivery return to delivery or surgery,[DIAGNOSES REDACTED], operative mortality, unplanned removal or injury of operative procedures and discrepancy between pre-op and post-op diagnosis.
- System or process issues identified in the review are shared in department meetings then improvement steps will be defined and implemented where necessary.

Review of the "Barnes-Jewish Hospital Bylaws of the Medical and Dental Staff," dated 09/2018, showed that:
- Qualifications of the active medical staff shall consist of practitioners who are geographically located so as to be able to provide continuous care to their patients admitted to the hospital within a reasonable period of time.
- The medical staff, through its credential's committee, designated department chiefs and with the assistance of hospital administration, shall investigate and consider each application for reappointment to the medical staff, and shall transmit recommendations to the Board or a designated Board Committee.
- The final decisions respecting appointment or clinical privileges are the sole responsibility of the Board. Such decisions by the Board shall take into consideration Medical Staff recommendations.
- The applicant is responsible for producing information for an adequate evaluation of the applicant's qualifications to perform the clinical privileges requested.
- Criteria for recommendation shall be based upon current professional competence and clinical judgement in the treatment of patients, the results of OPPE, quality assessment and utilization review activities, focused periodic professional evaluation (FPPE, a more focused review that medical staff can use after they identify a reason or a more thorough review to determine safe, quality care) and compliance with hospital Bylaws and Rules and Regulations.
- Peer reference may be required at reappointment if sufficient practitioner specific quality data is not available from the hospital's routine review functions.
- Privilege (the right of a physician to use the facilities and equipment of a hospital) determinations may also be based on information concerning clinical performance obtained from other sources, especially other institutions and health care settings where the practitioner exercised clinical privileges.
- Performance maintenance will be demonstrated by clinical activity in the area in which clinical privileges are sought with adequate volume to meet current clinical competence criteria.
- Failure to file a completed reappointment packet would result in the automatic lapse of a practitioner's admitting and clinical privileges at the end of the current appointment.

Review of the "Medical Staff Credentialing Committee Criteria," dated 12/05/16, showed that reappointment for level one practitioners required that "all data elements are present" and that quality data was available either from the hospital sources or provided by the member from "primary institution."

Review of the medical staff file for Staff C, Physician, showed that recredentialing paperwork submitted by, or on behalf of, Staff C, included the following:
- An email from Staff C addressed to the Medical Staff Services Coordinator, dated 05/02/19 at 4:04 PM, showed that Staff C verified his home address in Pasadena California (over 1800 miles away).
- A letter dated 05/03/19 from Barnes Jewish Hospital addressed to Staff C, which stated that the hospital's standard was to look at performance data for all practitioners with clinical privileges through OPPE, rather than just at the two year reappointment, and that Barnes Jewish Hospital had little or no inpatient clinical activity for Staff C, which made it difficult to assess clinical competencies. The letter requested specifically the completion of the Primary Institution Verification of Clinical Activity/Competence and the Physician Core Competency forms, filled out by "your primary facility Chief" and returned.
- An email dated 05/03/19 from Medical Staff Services and addressed to Staff C, requested him to have his "chief at your primary facility complete" a primary verification letter.
- Staff Cs documented practice information included his "primary practice" location in St. Louis, Missouri, specifically, the address to a local clinic (that provides abortions [surgical pregnancy termination]).
- A form titled, "Primary Institution Verification of Clinical Activity/Competence," was signed by a Professor and Chair of Obstetrics and Gynecology (OB/GYN, specialized care pertaining to pregnancy and the reproductive system of women), from a hospital in the state of California on 05/02/19, as part of the reappointment process for Barnes Jewish Hospital.
- His initial appointment to the California hospital medical staff was in January 2019 (approximately four months prior to the day the primary verification form was signed).
- During that time, he had 13 admissions, performed 12 procedures and had two consultations.
- Portions of the primary verification form, which included key metrics used to justify clinical activity and competence were left blank, including mortality (deaths) rates, length of inpatient stay, related readmissions, surgical site infection rates, patient satisfaction results and the privileges that the physician held at the California hospital.
- An email dated 05/09/19, from Barnes Jewish Medical Staff Services to Staff C, explained that the Primary Institution Verification was not complete, and directed him to have the form completed and returned.
- There was no indication that the form was completed and returned.
- Staff C's reappointment profile indicated that he had pending litigation (taking legal action against) related to an occurrence on 05/26/18, when a pregnancy termination was a failed procedure, and the patient was still pregnant approximately one month later. A second procedure was performed, and the patient was later hospitalized with an infection.
- He was recommended for reappointment to Barnes Jewish medical staff on 06/05/19, by Staff E, Interim Chair for OB/GYN.
- The dates between his original appointment on 07/20/17 and his first appraisal on 09/17/18 were 14 months apart.
- The next review had not been completed as of 06/20/19 which placed it at nine months since his last appraisal.

During an interview on 06/20/19 at 9:00 AM, Staff E, Interim Chair of OB/GYN and the Chair who recommended the reappointment of Staff C, stated that physician credentialing packet contents were verified by Barnes Jewish Hospital Credentialing Verification Organization (CVO), the department specific Chair, and then reviewed by the Credentials Committee and the Medical Executive Committee. Staff E explained that key metrics were used to determine if an applicant was appropriate for reappointment, and that morbidity (disease or medical problems caused by a treatment), follow-up surgery and litigation were some of the metrics included in that determination, and that the CVO reported any cases that were pending litigation. If there was a physician that did not have enough clinical activity within Barnes Jewish Hospital to determine competence for reappointment:
- Outside physicians would communicate clinical issues with the Barnes Jewish Hospital Chair of the department, and the clinical issues would be forwarded to the Morbidity and Mortality (M&M) Committee.
- He could contact the Medical Director for the physician's primary practice, and request feedback.
- He would review the information submitted in the reappointment file.
Staff E further stated that:
- He believed Staff C's home address was in St. Louis, Missouri.
- Staff C completed his fell owship (advanced practice in a specialty area) at the School of Medicine affiliated with Barnes Jewish Hospital from 2013-2015, and because of that, felt his training was more than adequate.
- When he reviewed Staff C's reappointment file, he assumed that the key metrics which were left blank, indicated that Staff C had "no cases (patient outcomes considered to be out of the normal)."
- He frequently spoke with Staff R, current Barnes Jewish Hospital Physician and medical director of the local clinic which was Staff C's primary practice, "and he would report anything out of the ordinary" related to Staff C's clinical practice.
- Staff R had never reported issues with Staff C's clinical practice.
- He did not call Staff R to request feedback specific to Staff C's clinical practice.
- He did not call the California hospital to verify why the key metrics portion of the file were left blank.
- There was no ongoing professional practice evaluation OPPE or FPPE.
- There was no pending litigation for Staff C.

Although requested, Staff C failed to respond to requests for an interview, and Barnes Jewish Hospital was unable to arrange an interview with the physician.

During an interview on 06/20/19 at 1:00 PM, Staff U, Board Member, Chair of Patient Care and Quality Committees, stated that:
- The Board was responsible for the final decisions for appointments reappointments and clinical privileges.
- Their decisions were based on the recommendations from other committees and the individual Department Chairs.
- The Board would have received a packet of all the information from previous committees.
- The Board looked to see that the application was complete, if there were any issues along the way, gaps in history, previous suspensions or malpractice.
- They will have taken into consideration the Level two and Level three submissions and asked questions about each one.

During an interview on 06/20/19 at 9:30 AM, Staff B, Assistant Chief Medical Officer, stated that:
- The evaluation of performance data occurs on continuous basis.
- Appraisals would be done annually and at a minimum of three times in a two year appointment period.
- Each department has their own set of criteria plus the facility's overall criteria of what data would be collected.
- Credentialing files would be listed as a level one (application has been completed and had correct information), level two (may have had a gap in history or had a hold on outside information), or level three (previous suspension, malpractice, or bad history) when they were sent to the different committees. Level two and level three would have a summary that stated why they had been placed at that specific level. Level one represented a completed packet and there were no issues.
- When no internal data was available the medical staff office would send out the Verification of Clinical Activity/Competence form to the practitioner for completion by the facility where the practitioner admitted or saw patients.
- Each review should be documented in the practitioner's files, the performance data should be entered into the data base and retrievable from the electronic record.

2. Review of a medical record for discharged Patient #4, showed that she electively chose to terminate (end) her pregnancy on 05/26/18, through a surgical procedure at a local clinic. The pregnancy termination was an abortion procedure that failed, and a second abortion procedure was attempted on 06/30/18. The second abortion procedure was incomplete. Staff C performed both procedures. Two days later, the patient presented to Barnes Jewish Hospital ED with lower stomach pain, fever and an elevated heart rate and blood pressure. The patient was admitted (under the care of another physician) to the Intensive Care Unit, underwent a procedure to remove additional remains of the pregnancy, which was an infectious bacterial source.

Review of the facility's policy titled, "Department of Anesthesiology Ongoing Professional Practice Evaluation," dated 02/2010, showed:
- Individual physician practice data is reviewed at least every eight months and prior to re-appointment.
- Types of data reviewed specific to Anesthesia are intra-operative and non-operative volume, antibiotic delivery, patient temperature upon arrival to Post Anesthesia Care Unit (PACU), and peer review (review by physicians of another physicians work and documentation when there has been an issue with patient care) results if any.
- The process is employed consistently for all members of the department without exception.
- Departmental quality data report is provided to the Division and Department Chief.
- Reports with individual physician practices would be sent to Medical Staff Services and stored in the individual credentialing file.

Review of the credentialing file, on 06/20/19, for Staff M, Physician, showed:
- His original appointment was on 10/09/17 and his last appraisal on 08/13/18, or in 10 months rather than eight.
- He did not have any performance data in the electronic data base.
- He did not have any appraisal information or demonstrated professional competencies documented in his credentialing file.
- Staff failed to collect and store performance/professional competencies, and failed to perform Staff M's OPPE in eight months as directed by their policy.