HospitalInspections.org

Based on a review of facility documents and staff interviews (EMP), it was determined that Penn Highlands Clearfield failed to ensure that activities within their adopted Performance Improvement program, included that an evaluation was conducted on all contracted services furnished to the hospital, and failed to ensure that such activities were reported to established Quality Committees.

Findings include:

Review of "Amended and Restated Bylaws of Clearfield Hospital d/b/a Penn Highlands Clearfield ... ", dated June 29, 2020, revealed "... Article VIII Quality Assurance. Section 8.1 Board Responsibility. The Board shall establish, maintain, support and exercise oversight of a continuous Quality Assurance Program that includes specific and effective review, evaluations and monitoring mechanisms to assess, preserve and improve the overall quality and efficiency of patient care within this Corporation ... ."

Review of "Penn Highlands Clearfield Quality Assessment Performance Improvement Plan FY 2021", revealed "... This QAPI Plan has been designed as a mechanism to assure: Quality and patient safety standards are met through an efficient and outcomes-based accreditation program; the CMS Conditions of Participation and PA DOH regulations ... Opportunities to continuously improve patient care and services proactively are pursued ... The Board of Directors has the ultimate responsibility for performance improvement and for assuring safe and high quality patient care ... The Board of Directors ensures the following: That an ongoing program for quality improvement and patient safety including the reduction of medical errors is defined, implemented and maintained. That hospital wide QAPI efforts address priorities for improved quality of care and improved patient safety ... Organizational Excellence Council (OEC) has the role of oversight for the quality management system at Penn Highlands Clearfield. OEC in collaboration with the Executive Leadership, Quality, Safety and Service Excellence Steering Committees and BQOC (Board Quality Oversight Committee) is responsible for ... Ensuring that the organization designs processes well and systematically monitors, analyzes, and improves key processes, functions and services through internal audits while sustaining performance to improve patient outcomes ... ."

Review of Appendix E-Quality Excellence Reporting Matrix. PHC Quality Excellence Report Out Schedule, noted to be revised August 2020, indicated that Contracted Services would be reported in July and subsequently in January.

1. Surveyor requested a List of Contracted Services, and facility evaluations of contracts. Facility provided surveyor with two lists, one which listed Penn Highlands Healthcare as the contracted entity. There were approximately 167 listings, of which approximately 143 contracts included Penn Highlands Clearfield and/or stated the contract was system wide, and another list that listed approximately 21 contracted services relative to Penn Highlands Clearfield. In addition, surveyor was provided with a Shared Service Agreement between the subsidiaries for Penn Highlands Healthcare and Home Care Operations. During review, it was noted that Penn Highlands Clearfield, was the recipient organization for approximately eight of the Description of Services reviewed.

2. Surveyor requested evidence of quality on contracted services. Surveyor was provided with only a sample of three quality documents relative to contracted services, and it was confirmed by EMP2 that these have not been reported to any facility committee.

3. Interview with EMP2 and EMP6, on August 20, 2020, confirmed that quality documentation has not been completed for all contracted services, and further stated that quality documentation related to contracted services is not reflected in the facility's applicable Quality Meeting Minutes.

Based on a review of facility documents, credentialing documents (CF), and staff interview (EMP), it was determined the Medical Staff failed to adopt Medical Staff Bylaws and Credentialing Policies, which failed to ensure that adopted processes did not delegate the responsibility from the Governing Body, for appointments to the medical staff, as evidenced by review of 11 of 13 credential files. (CF1, CF3, CF4, CF5, CF8, CF9, CF10, CF11, CF12, CF13, CF15)

Review of "Penn Highlands Brookville; Clearfield; DuBois; Elk; Huntingdon; DuBois Surgery Center; DuBois Endoscopy Center Medical Staff Bylaws", dated June 2020, revealed Adoption: Medical Staff Bylaws Adoption by Penn Highlands Brookville: Medical Staff President signature dated June 16, 2020, President signature dated June 23, 2020 ... Adopted by Penn Highlands Clearfield: Medical Staff President signature dated June 16, 2020, President signature dated June 22, 2020 ... Adopted by Penn Highlands DuBois: Medical Staff President signature dated June 8, 2020, President signature dated June 16, 2020 ... Adopted by Penn Highlands Elk: Medical Staff President signature dated June 24, 2020, President signature dated June 25, 2020 ... Adopted by Penn Highlands Huntingdon: Medical Staff President signature dated June 10, 2020, President signature dated June 17, 2020 ... Article I: General Provisions ... Section 1.2 Certain Defined Terms ... "Hospital President" is defined as the individual appointed by the Hospital Board of Directors to act on its behalf in the overall management of the hospital ... The Medical Staff may rely upon all actions of the Hospital President as being the actions of the Board of Directors taken pursuant to a proper delegation of authority from the Board of Directors ... "Medical Staff Bylaws" means the Medical Staff Bylaws-Governance Section, the Credentials Procedures Section ... and the Organization and Function Section of the Bylaws. The Medical Staff Bylaws apply to all Penn Highlands Healthcare facilities ... Article II: Medical Staff Membership ... Section 2.3 Conditions and Duration of Appointment. A. Initial appointments and reappointments to the Medical Staff shall be granted by the Board of Directors. the Board of Directors shall act on appointments and reappointments only after there has been a recommendation from the Medical Executive Committee (MEC) in accordance with the provision of these Bylaws ... Section 2.4 Staff Dues and Fees. A. Annual Medical Staff dues shall be governed by the most recent action which has been recommended by the MEC and adopted at a regular or special staff meeting ... B. Medical Staff Officers and Honorary Staff members will not be required to pay dues. The Medical Staff President may recommend additional waivers as identified in the medical staff finance policy. C. Dues shall be payable within thirty (30) days of the first day of the medical staff year (July 1). Failure to pay pay annual dues shall be construed as a voluntary resignation from the staff ... I. Each staff member must permit the Hospital and medical staff to share peer review, credentialing/privileging, Human Resources information (for employed members), and performance information with any related healthcare entity and medical staff committee affiliated with Penn Highlands Healthcare entity at which the member holds membership and/or privileges ... Article III: Categories of the Medical Staff. Section 3.1 Active Medical Staff. A. Qualifications: Appointees to the category must: a. Admit or otherwise be involved in a minimum of fifty (50) patient contacts at the member's designated primary hospital in a two year period ... B. Prerogatives: Appointees to this Category may: a. Admit patients without limitation, except as otherwise provided in the Medical Staff Rules and Regulations, or by specific privilege restriction. b. Vote on all matters presented at their primary Hospital general and special meetings of the Medical Staff. Vote on all matters at their primary hospital and system committees, department and clinical service of which (s) he is appointed; c. Hold office and/or be the chairperson or member of any committee, unless otherwise specified elsewhere in the Bylaws. C. Responsibilities: Appointees to this category must: a. Contribute as defined by the Organization and Functions Procedures to the organizational and administrative affairs of the Medical Staff.b. Actively participate in recognized functions of Staff appointment including quality improvement and other monitoring activities, in monitoring initial appointees and in discharging other staff functions as may be required from time to time. c. Participate in the emergency service and other special coverage programs as determined by the MEC based on a recommendation from the department chairperson ... Section 3.2 Active Affiliate Medical Staff. A. Qualifications: Appointees to this category must: a. The Active Affiliate Category is reserved for practitioners who do not meet the eligibility requirements for the active category or choose not to pursue active status. Practitioners assigned to this category, may admit or otherwise be involved in the care or treatment of patients in providing consultations; ordering diagnostic or therapeutic services consistent with their Board approved privileges ... This category is also appropriate for those practitioners who may not have admitting privileges; but document other important efforts (i.e. teaching or telemedicine) which support the hospital's patient care mission to the satisfaction of the MEC and Board of Directors .... B. Prerogatives: Appointees to this category may: a. Admit patients in the same manner as an Active Medical Staff member, consistent with privileging criteria ... c. Not vote at General Medical Staff meetings or hold office. d. Attend meetings of the General Medical Staff (without vote) and may attend and vote at their primary Hospital or System committee and department, and clinical service, as appropriate of which (s) he is an appointee and may attend any medical or Hospital education programs ... Article VI: Medical Executive Committee & Physician Leadership Council Section 6.1 Designation and Substitution. A. There shall be a Medical Executive Committee ... at each Penn Highlands Healthcare hospital and one system Physician Leadership Council ... and such other standing and special committees as established by each MEC and the PLC as listed in the Organization and Functions section of these bylaws. Each MEC shall directly report the results and recommendations of each medical staff function to their respective Hospital Board. Those functions requiring participation of, rather than direct oversight by, the medical staff may be discharged by medical staff representation on such Penn Highlands Healthcare medical staff committees or hospital committees as are established to perform such functions ... ."

Review of "Penn Highlands Brookville; Clearfield; DuBois; Elk; Huntingdon; DuBois Surgery Center; DuBois Endoscopy Center Credentials Policy and Procedures Manual ... ", dated June 2020, revealed "... Adoption: Credentials Policy & Procedure Manual. Adopted by Penn Highlands Brookville: Medical Staff President signature dated June 16, 2020, President signature dated June 23, 2020, Board of Directors Chairman signature dated June 23, 2020; Adopted by Penn Highlands Clearfield: Medical Staff President signature dated June 16, 2020, President signature dated June 22, 2020, Board of Directors Chairman signature dated June 22, 2020; Adopted by Penn Highlands DuBois: Medical Staff President signature dated June 8, 2020, President signature dated June 16, 2020, Board of Directors Chairman signature dated June 16, 2020; Adopted by Penn Highlands Elk: Medical Staff President signature dated June 24, 2020, President signature dated June 25, 2020, Board of Directors Chairman signature dated June 25, 2020; Adopted by Penn Highlands Huntingdon: Medical Staff President signature dated June 10, 2020, President signature dated June 17, 2020, Board of Directors Chairman signature dated June 17, 2020 ... Article II. Application & Qualifications for Appointment & Reappointment. 2.1 Requests for Application. All requests for applications for membership appointment to the medical staff, or requests for privileges (i.e. telemedicine, APPs) will be made to the MSP (Medical Staff Professional) and forwarded to the primary Hospital President and to each PHH MSP. The MSPs will communicate back to the primary Hospital MSP if the applicant is applying to or already holds medical staff membership, privileges, exclusive or non-exclusive contract (s) or employment agreement (s) at any PHH sponsored hospital or any PHH related healthcare facility. The primary Hospital MSP will communicate all applicant information received from the PHH MSPs to the primary Hospital President. The MSP will update the privilege delineation form (as appropriate) noting any APP sponsorship, any specific on-call coverage requirements and specifying which facilities the applicant is eligible to request privileges consistent with the Board approved Medical Staff Development Plan. Upon the approval of the primary Hospital President, the MSP will provide the potential applicant with an application along with the following information ... 2.2.17 Upon receipt of a completed initial or reappointment application (as appropriate), the primary Hospital MSP will verify all information contained on the application from the primary source ... In the event the requirements are met, the primary Hospital MSP will forward the initial or reappointment application to each PHH Hospital MSP where the applicant or re-applicant is requesting privileges. The MSP will forward the the application/reapplication to the Hospital President, the Medical Staff President, and to the Credentials Committee Chair ... Article III: ... 3.2 The applicant must sign the application and in so doing ... Authorizes Hospital representatives to consult with others who have been associated with him/her and/or who have information bearing on his/her competence and qualifications. Permits the Hospital and Medical Staff leaders and the Human Resources Department staff (for employed physicians) to share peer review, employment background and performance information within the Penn Highlands Hospitals and Penn Highlands Healthcare System committees pertaining to Credentialing, Privileging, Peer Review, and Fair Hearing/Appeal activities ... 3.3.3 The following documentation is necessary to have a "complete" application that is eligible for processing through the Medical Staff and Board of Directors. It is the applicant's responsibility to provide: A. A typed or legible, complete, signed and dated application form requesting the applicant to designate their primary Penn Highlands Hospital (Brookville, Clearfield, DuBois, Elk, Huntingdon) and request for privileges. Note: the "primary Hospital" is where the member will: i. typically admit or intend to refer the majority of their inpatients or outpatients; ii. vote on department, clinical service or general medical staff issues; iii. have their application and reapplication for membership and privileges requests processed through the MEC; and iv. have individual (specific to their performance) peer review, utilization and quality and performance outcome data reviewed, discussed and documented ... 3.3.7 Upon receipt of the application, the primary Hospital MSP will verify from primary source the application contents and collect additional information ... 3.5 Expedited Initial Application Review and Approval Process ... 3.5.3 Procedure for Processing Category I Expedited Applications: A. The Hospital Department chief reviews the entire file and documents their findings on the Department Chief Section of the Initial Recommendation Flow Record, then forwards a recommendation to the Credentials Committee Chair. B. The Credentials Committee Chair, on behalf of the Credentials Committee, reviews the completed and verified application; as well as, the recommendation from the Department Chief and the interview documentation form. The Credentials Committee Chair forwards a recommendation to the Medical Staff President. C. The Medical Staff President, on behalf of the MEC, reviews the recommendation from the Credentials Committee Chair and determines if the application continues to be processed as a Type I "expedited file" or as a Type II "full review file." D. The Medical Staff President forwards a recommendation to the Hospital President. E. The Hospital President evaluates the qualifications of the applicant and grants Medical Staff membership and privileges on behalf of the Board. F. At its next regularly scheduled meeting, the full Board considers and, if appropriate, ratifies all Type I application ... 5.2 Procedure for Processing Application for Staff Reappointments ... 5.2.1 After the Medical Staff Office has obtained a complete application for medical staff reappointment, the reapplication information will be verified by primary source and then be sent for review by the Credentials Committee Chairman and the Department Chief. After considering the recommendation of the Department Chief, the Credentials Chair will decide if the applicant is processed as a Category I ("expedited reappointment") or a Category II ("full review reappointment") ... ."

2. A focused review of 13 credentialing documents, was completed, and it was noted that 11 of 13 (CF1, CF3, CF4, CF5, CF8, CF9, CF10, CF11, CF12, CF13, CF15) files indicated that expedited appointment/reappointment/privileges, were granted. All noted were based on recommendation of Credentials Committee Chair, the Department Chief or Acting Department Chief, and the Medical Staff President. All letters were noted to be signed by the Hospital President.

3. Interview with EMP1 and EMP4 on August 19, 2020, confirmed the expedited credentialing process as outlined in the findings, and that the Hospital President grants Medical Staff membership and privileges on behalf of the Board.

Based on a review of facility documents, credentialing documents (CF), and staff interview (EMP), it was determined the Medical Staff failed to adopt Medical Staff Bylaws, Credentialing Policies and other Medical staff policies, which were not shared with other licensed and/or certified Penn Highlands facilities, and failed to ensure that the credentialing of Emergency Department Physicians was consistent with adopted Emergency Department Staffing Policy.

Findings include:

Review of "Penn Highlands Brookville; Clearfield; DuBois; Elk; Huntingdon; DuBois Surgery Center; DuBois Endoscopy Center Medical Staff Bylaws", dated June 2020, revealed Adoption: Medical Staff Bylaws Adoption by Penn Highlands Brookville: Medical Staff President signature dated June 16, 2020, President signature dated June 23, 2020 ... Adopted by Penn Highlands Clearfield: Medical Staff President signature dated June 16, 2020, President signature dated June 22, 2020 ... Adopted by Penn Highlands DuBois: Medical Staff President signature dated June 8, 2020, President signature dated June 16, 2020 ... Adopted by Penn Highlands Elk: Medical Staff President signature dated June 24, 2020, President signature dated June 25, 2020 ... Adopted by Penn Highlands Huntingdon: Medical Staff President signature dated June 10, 2020, President signature dated June 17, 2020 ... Article I: General Provisions ... Section 1.2 Certain Defined Terms ... "Hospital President" is defined as the individual appointed by the Hospital Board of Directors to act on its behalf in the overall management of the hospital ... The Medical Staff may rely upon all actions of the Hospital President as being the actions of the Board of Directors taken pursuant to a proper delegation of authority from the Board of Directors ... "Medical Staff Bylaws" means the Medical Staff Bylaws-Governance Section, the Credentials Procedures Section ... and the Organization and Function Section of the Bylaws. The Medical Staff Bylaws apply to all Penn Highlands Healthcare facilities ... Article II: Medical Staff Membership ... Section 2.3 Conditions and Duration of Appointment. A. Initial appointments and reappointments to the Medical Staff shall be granted by the Board of Directors. the Board of Directors shall act on appointments and reappointments only after there has been a recommendation from the Medical Executive Committee (MEC) in accordance with the provision of these Bylaws ... Section 2.4 Staff Dues and Fees. A. Annual Medical Staff dues shall be governed by the most recent action which has been recommended by the MEC and adopted at a regular or special staff meeting ... B. Medical Staff Officers and Honorary Staff members will not be required to pay dues. The Medical Staff President may recommend additional waivers as identified in the medical staff finance policy. C. Dues shall be payable within thirty (30) days of the first day of the medical staff year (July 1). Failure to pay pay annual dues shall be construed as a voluntary resignation from the staff ... I. Each staff member must permit the Hospital and medical staff to share peer review, credentialing/privileging, Human Resources information (for employed members), and performance information with any related healthcare entity and medical staff committee affiliated with Penn Highlands Healthcare entity at which the member holds membership and/or privileges ... Article III: Categories of the Medical Staff. Section 3.1 Active Medical Staff. A. Qualifications: Appointees to the category must: a. Admit or otherwise be involved in a minimum of fifty (50) patient contacts at the member's designated primary hospital in a two year period ... B. Prerogatives: Appointees to this Category may: a. Admit patients without limitation, except as otherwise provided in the Medical Staff Rules and Regulations, or by specific privilege restriction. b. Vote on all matters presented at their primary Hospital general and special meetings of the Medical Staff. Vote on all matters at their primary hospital and system committees, department and clinical service of which (s) he is appointed; c. Hold office and/or be the chairperson or member of any committee, unless otherwise specified elsewhere in the Bylaws. C. Responsibilities: Appointees to this category must: a. Contribute as defined by the Organization and Functions Procedures to the organizational and administrative affairs of the Medical Staff. b. Actively participate in recognized functions of Staff appointment including quality improvement and other monitoring activities, in monitoring initial appointees and in discharging other staff functions as may be required from time to time. c. Participate in the emergency service and other special coverage programs as determined by the MEC based on a recommendation from the department chairperson ... Section 3.2 Active Affiliate Medical Staff. A. Qualifications: Appointees to this category must: a. The Active Affiliate Category is reserved for practitioners who do not meet the eligibility requirements for the active category or choose not to pursue active status. Practitioners assigned to this category, may admit or otherwise be involved in the care or treatment of patients in providing consultations; ordering diagnostic or therapeutic services consistent with their Board approved privileges ... This category is also appropriate for those practitioners who may not have admitting privileges; but document other important efforts (i.e. teaching or telemedicine) which support the hospital's patient care mission to the satisfaction of the MEC and Board of Directors .... B. Prerogatives: Appointees to this category may: a. Admit patients in the same manner as an Active Medical Staff member, consistent with privileging criteria ... c. Not vote at General Medical Staff meetings or hold office. d. Attend meetings of the General Medical Staff (without vote) and may attend and vote at their primary Hospital or System committee and department, and clinical service, as appropriate of which (s) he is an appointee and may attend any medical or Hospital education programs ... Article VI: Medical Executive Committee & Physician Leadership Council Section 6.1 Designation and Substitution. A. There shall be a Medical Executive Committee ... at each Penn Highlands Healthcare hospital and one system Physician Leadership Council ... and such other standing and special committees as established by each MEC and the PLC as listed in the Organization and Functions section of these bylaws. Each MEC shall directly report the results and recommendations of each medical staff function to their respective Hospital Board. Those functions requiring participation of, rather than direct oversight by, the medical staff may be discharged by medical staff representation on such Penn Highlands Healthcare medical staff committees or hospital committees as are established to perform such functions ... ."

Review of "Penn Highlands Healthcare Brookville; Clearfield; DuBois; Elk; Huntingdon; DuBois Surgery Center; DuBois Endoscopy Center Appendix B Organization and Functions Section", dated June 2020, revealed "... Adoption: Organization and Functions Section. Adopted by Penn Highlands Brookville: Medical Staff President signature dated June 16, 2020, President signature dated June 23, 2020, Board of Directors Chairman signature dated June 23, 2020; Adopted by Penn Highlands Clearfield: Medical Staff President signature dated June 16, 2020, President signature dated June 22, 2020, Board of Directors Chairman signature dated June 22, 2020; Adopted by Penn Highlands DuBois: Medical Staff President signature dated June 8, 2020, President signature dated June 16, 2020, Board of Directors Chairman signature dated June 16, 2020; Adopted by Penn Highlands Elk: Medical Staff President signature dated June 24, 2020, President signature dated June 25, 2020, Board of Directors Chairman signature dated June 25, 2020; Adopted by Penn Highlands Huntingdon: Medical Staff President signature dated June 10, 2020, President signature dated June 17, 2020, Board of Directors Chairman signature dated June 17, 2020 ... ."

Review of "Penn Highlands Brookville; Clearfield; DuBois; Elk; Huntingdon; DuBois Surgery Center; DuBois Endoscopy Center Credentials Policy and Procedures Manual ... ", dated June 2020, revealed "... Adoption: Credentials Policy & Procedure Manual. Adopted by Penn Highlands Brookville: Medical Staff President signature dated June 16, 2020, President signature dated June 23, 2020, Board of Directors Chairman signature dated June 23, 2020; Adopted by Penn Highlands Clearfield: Medical Staff President signature dated June 16, 2020, President signature dated June 22, 2020, Board of Directors Chairman signature dated June 22, 2020; Adopted by Penn Highlands DuBois: Medical Staff President signature dated June 8, 2020, President signature dated June 16, 2020, Board of Directors Chairman signature dated June 16, 2020; Adopted by Penn Highlands Elk: Medical Staff President signature dated June 24, 2020, President signature dated June 25, 2020, Board of Directors Chairman signature dated June 25, 2020; Adopted by Penn Highlands Huntingdon: Medical Staff President signature dated June 10, 2020, President signature dated June 17, 2020, Board of Directors Chairman signature dated June 17, 2020 ... Article II. Application & Qualifications for Appointment & Reappointment. 2.1 Requests for Application. All requests for applications for membership appointment to the medical staff, or requests for privileges (i.e. telemedicine, APPs) will be made to the MSP (Medical Staff Professional) and forwarded to the primary Hospital President and to each PHH MSP. The MSPs will communicate back to the primary Hospital MSP if the applicant is applying to or already holds medical staff membership, privileges, exclusive or non-exclusive contract (s) or employment agreement (s) at any PHH sponsored hospital or any PHH related healthcare facility. The primary Hospital MSP will communicate all applicant information received from the PHH MSPs to the primary Hospital President. The MSP will update the privilege delineation form (as appropriate) noting any APP sponsorship, any specific on-call coverage requirements and specifying which facilities the applicant is eligible to request privileges consistent with the Board approved Medical Staff Development Plan. Upon the approval of the primary Hospital President, the MSP will provide the potential applicant with an application along with the following information ... 2.2.17 Upon receipt of a completed initial or reappointment application (as appropriate), the primary Hospital MSP will verify all information contained on the application from the primary source ... In the event the requirements are met, the primary Hospital MSP will forward the initial or reappointment application to each PHH Hospital MSP where the applicant or re-applicant is requesting privileges. The MSP will forward the the application/reapplication to the Hospital President, the Medical Staff President, and to the Credentials Committee Chair ... Article III: ... 3.2 The applicant must sign the application and in so doing ... Authorizes Hospital representatives to consult with others who have been associated with him/her and/or who have information bearing on his/her competence and qualifications. Permits the Hospital and Medical Staff leaders and the Human Resources Department staff (for employed physicians) to share peer review, employment background and performance information within the Penn Highlands Hospitals and Penn Highlands Healthcare System committees pertaining to Credentialing, Privileging, Peer Review, and Fair Hearing/Appeal activities ... 3.3.3 The following documentation is necessary to have a "complete" application that is eligible for processing through the Medical Staff and Board of Directors. It is the applicant's responsibility to provide: A. A typed or legible, complete, signed and dated application form requesting the applicant to designate their primary Penn Highlands Hospital (Brookville, Clearfield, DuBois, Elk, Huntingdon) and request for privileges. Note: the "primary Hospital" is where the member will: i. typically admit or intend to refer the majority of their inpatients or outpatients; ii. vote on department, clinical service or general medical staff issues; iii. have their application and reapplication for membership and privileges requests processed through the MEC; and iv. have individual (specific to their performance) peer review, utilization and quality and performance outcome data reviewed, discussed and documented ... 3.3.7 Upon receipt of the application, the primary Hospital MSP will verify from primary source the application contents and collect additional information ... 3.5 Expedited Initial Application Review and Approval Process ... 3.5.3 Procedure for Processing Category I Expedited Applications: A. The Hospital Department chief reviews the entire file and documents their findings on the Department Chief Section of the Initial Recommendation Flow Record, then forwards a recommendation to the Credentials Committee Chair. B. The Credentials Committee Chair, on behalf of the Credentials Committee, reviews the completed and verified application; as well as, the recommendation from the Department Chief and the interview documentation form. The Credentials Committee Chair forwards a recommendation to the Medical Staff President. C. The Medical Staff President, on behalf of the MEC, reviews the recommendation from the Credentials Committee Chair and determines if the application continues to be processed as a Type I "expedited file" or as a Type II "full review file." D. The Medical Staff President forwards a recommendation to the Hospital President. E. The Hospital President evaluates the qualifications of the applicant and grants Medical Staff membership and privileges on behalf of the Board. F. At its next regularly scheduled meeting, the full Board considers and, if appropriate, ratifies all Type I application ... 5.2 Procedure for Processing Application for Staff Reappointments ... 5.2.1 After the Medical Staff Office has obtained a complete application for medical staff reappointment, the reapplication information will be verified by primary source and then be sent for review by the Credentials Committee Chairman and the Department Chief. After considering the recommendation of the Department Chief, the Credentials Chair will decide if the applicant is processed as a Category I ("expedited reappointment") or a Category II ("full review reappointment") ... ."

Review of Penn Highlands Clearfield Emergency Department policy entitled "Physician Staffing", dated June 2020, revealed "... The physicians are employed by Penn Highlands Healthcare and are active members of the medical staff ... ."

1. A review of credentialing documents was completed. During review of credential files with EMP1, they stated that applicants designate a primary hospital where they will be active and vote, and pay dues, and at the other Penn Highlands Hospitals they would be active affiliate, which means they will not pay dues, vote, participate in on-call, or be required to attend meetings. Per EMP1, physicians chose which category of medical staff in which they wanted to apply. Interview with EMP1 on August 20, 2020, revealed while reviewing the list of Penn Highlands Clearfield medical staff that active affiliate staff, for the most part are active at another Penn Highlands facility, and that no one is active at more than one Penn Highlands Hosptial. When queried about the application process, EMP1 stated that letters had been sent previously to the medical staff to indicate for them to choose their medical staff category.

2. A sample of correspondence labelled Penn Highlands Heathcare, for five (CF1, CF2, CF6, CF9, CF10) medical staff members dated June 6, 2018, was completed. The correspondence was noted to state "... The redesigned Medical Staff Bylaws will be implemented on July 1 containing new enhancements such as streamlined medical staff categories and credentialing and privileging processes and procedures ... Please take a few minutes to answer the general information questions below. (1) Designate your primary Penn Highlands Healthcare Hospital ... (2) Designate your medical staff category at your primary hospital ... Active Medical Staff ... Active Affiliate Medical Staff ... Honorary Medical Staff ... Note: A provider can only hold one Active Medical Staff Category in the PHH System. Example: Dr ... designates PH Brookville as his/her primary hospital and selects Active Staff category upon meeting all requirements. Dr ... also holds membership/privileges at PH Clearfield, PH DuBois, and PH Elk. Therefore, Dr ... will hold Active Staff category, voting rights, and pay annual dues to PH Brookville only. Dr ... will hold Active Affiliate Staff category at PH Clearfield, PH DuBois, and PH Elk ... You will be notified by your designated primary hospital regarding the dues fee ... .
3. During review of the Penn Highlands Clearfield Medical Staff Active/ Affiliate Staff/Privileges Only/Honorary Listing, it was noted to include approximately 34 physicians with noted specialty of Emergency Medicine. During review, it was noted that 16 had a staff status of privileges only, 14 had a staff status of active affiliate, and four had staff status of active. This was noted to be inconsistent with the facility's adopted Emergency Department Policy related to physician staffing.

4. During continued review, it was noted that the List was noted to include approximately 34 physicians noted specialty of Hospitalist. During review, it was noted that 18 had a staff status of privileges only, 16 had a staff status of active affiliate, and none were noted to have a staff status of active.

5. Interview with EMP3 on August 20, 2020, revealed that the Medical Staff is not unified.

Based on a review of facility credentialing documents, credential files (CF) and staff interview (EMP), it was determined that Penn Highlands Clearfiled failed to follow their adopted Credentialing policy to ensure that privileges for locum tenens was granted for a limited period of time (physicians serving short locum tenens positions), as evidenced by one of one applicable credential files reviewed (CF4), and failed to adopt Medical Staff Bylaws/Medical Staff credentialing policies by failing to ensure requirements that physicians granted privileges only (locum tenens) were assigned to a category of the Medical Staff.

Findings include:

Review of "Penn Highlands Brookville; Clearfield; DuBois; Elk; Huntingdon; DuBois Surgery Center; DuBois Endoscopy Center Medical Staff Bylaws", dated June 2020, revealed "... Membership on any Medical Staff of the Penn Highlands Healthcare Hospitals is a privilege which shall be extended only to professionally competent physicians, podiatrists, and dentists who continually meet the qualifications, standards, requirements, and obligations of appointment specified in the Medical Staff Bylaws, Rules and Regulations and applicable Hospital policies and directives ... Article III: Categories of the Medical Staff. Section 3.1 Active Medical Staff ... Appointees to the category must: a. Admit or otherwise be involved in a minimum of fifty (50) patient contacts at the member's designated primary hospital in a two year period. A patient contact is defined as an inpatient admission or referral, consultation, or performance of an inpatient or outpatient surgical procedure; except as expressly waived for practitioners with at least (20) years of service in the active category and/or for those practitioners who document their efforts to support the hospital's patient care mission to the satisfaction of the MED and Board of Directors ... Practitioners in the Active Category who do not have Clinical Privileges may visit their patients in the Penn Highlands Healthcare Hospital to review records, attend and vote at general medical staff and department meetings, CME functions and social events. Active members with no Clinical Privileges may not manage patients at any Penn Highlands Healthcare Hosptial or related facility or make notations in the medical record. Section 3.2 Active Affiliate Medical Staff ... Appointees to this category is reserved for practitioners who do not meet the eligibility requirements for the active category or choose not to pursue active status. Practitioners assigned to this category, may admit or otherwise be involved in the care or treatment of patients in providing consultations; ordering diagnostic or therapeutic services consistent with their Board approved privileges. Active Affiliate members may refer patients to other physicians on the staff of any Penn Highlands Healthcare Hospital. This category is also appropriate for those practitioners who may not have admitting privileges; but document other important efforts (i.e. teaching or telemedicine) which support the hospital's patient care mission to the satisfaction of the MED and Board of Directors ... Practitioners in the Active/Affiliate Category who do not have Clinical Privileges may visit their patients in the Penn Highlands Healthcare Hospital to review medical records, attend and vote at department meetings, CME functions and social events. Active/Affiliate Members with no Clinical Privileges may not manage patients at any Penn Highlands Healthcare Hospital or related faciltiy or make notations in the medical record. Section 3.3 Honorary Medical Staff ... The Honorary Staff shall consist of those practitioners who are not active in the Hospital ... ."

Review of "Penn Highlands Brookville; Clearfield; DuBois; Elk; Huntingdon; DuBois Surgery Center; DuBois Endoscopy Center Credentials Policy and Procedures Manual ... ." dated June 2020, revealed "... Article VI: Clinical Privileges. 6.1 Exercise of Privileges ... Privileges may be granted by the Board upon recommendation of the MEC to practitioners who are not members of the medical staff. Such individuals may be ... physicians serving short locum tenens positions ... 6.6.2 ... 2. Temporary Privileges to Fulfill an Important Patient Care, Treatment, and Service Need. Locum Tenens: Upon receipt of a written request for specific temporary privileges, an appropriately licensed practitioner of documented competence who is serving as a locum tenens for an appointee of the medical staff may, without applying for permanent appointment on the staff, be granted temporary privileges for a period of up to 120 days. At the end of this time, the practitioner is required to apply for appointment to the medical staff ... ."

1. During review of the Penn Highlands Clearfield Medical Staff Active/ Affiliate Staff/Privileges Only/Honorary Listing, it was noted to include approximately 34 physicians with noted specialty of Emergency Medicine. During review, it was noted that 16 had a staff status of privileges only.

During continued review, it was noted that the List was noted to include approximately 34 physicians noted specialty of Hospitalist. During review, it was noted that 18 had a staff status of privileges only. During review, EMP1 stated that privileges only generally means these physicians are long term locum tenens.

2. During review of CF4, it was noted that this hospitalist was granted expedited privileges, for privileges only staff effective August 19, 2019 through March 31, 2021.

Based on a review of facility documents, it was determined that Penn Highlands Clearfield failed to adopt Medical Staff Bylaws which described any Clinical Services/scope of activities.

Findings include:

1. Review of "Penn Highlands Brookville; Clearfield; DuBois; Elk; Huntingdon; DuBois Surgery Center; DuBois Endoscopy Center Medical Staff Bylaws", dated June 2020, revealed "... Section 5.5 Clinical Services. A. Optional Clinical Services may be organized by the medical staff and must be formally approved by the MEC. The Clinical Services authorized by the MEC shall be listed in the Organization and Functions Section of these Bylaws. B. Each clinical service shall have a chief with overall responsibility for the supervision and satisfactory discharge of assigned functions as listed in Article V, Section 5.5 D. C. The MEC may recognize any group of practitioners who wish to organize themselves into a clinical service. Any clinical service, if organized, is not required to hold regularly scheduled meetings, nor is attendance mandated. Routine minutes are not required. A written report is required only when the clinical service is making a formal report. When a clinical service is making a formal report, the report shall be submitted to the appropriate Medical Staff committee documenting the specific position of the Clinical Service. The committee chair and the Clinical Service chief will decide if the report/issue is placed on the committee agenda and whether the Clinical Service chief will decide if the the report/issue is placed on the committee agenda and whether the Clinical Service chief (or designee) will attend the committee meeting to present the report/issue and participate in the vote of the committee on that specific report/issue. Clinical services are completely optional and shall exist to perform any of the following activities: a. Elect a chief and determine meeting frequency and communication preferences; b. Continuing education a discussion of patient care; c. Grand rounds and clinical protocol development and outcomes; d. Discussion of policies and procedures; e. Discussion of facility and equipment needs; f. Development of reports, evaluation or discussion of a particular issue at the request of the MEC; and g. Participation in the development of criteria for clinical privileges when requested by the Credentials Committee or the MEC ... Qualifications, Selection, Term, and Removal of Clinical Service Chief. a. Each Clinical Service chief shall serve a term of two (2) years commencing on July 1 and is eligible to serve successive terms. All chiefs must be members of the active staff with relevant clinical privileges and certified by an appropriate specialty board or have affirmatively established comparable competence through the privilege delineation process ... Assignment to Clinical Service. a. The MEC will, after consideration of the report of the appropriate Clinical Service chief, as transmitted to through the Credentials Committee, recommend Clinical Service assignments for members in accordance with their qualifications. Each member who may be assigned to a Clinical Service may vote at their primary Hospital Clinical Service meeting. Clinical Service members are encouraged to attend and are eligible to vote at the primary Hospital Department meeting. Clinical privileges are independent to Department or Clinical Service assignment ... ."

2. Review of "Penn Highlands Healthcare Brookville; Clearfield; DuBois; Elk; Huntingdon; DuBois Surgery Center; DuBois Endoscopy Center Appendix B Organization and Functions Section ...", dated June 2020, revealed "... Organization of the Medical Staff ... Each MEC may authorize any group of like specialists who wish to be formally recognized as a clinical service. Clinical services may exist at each facility as authorized by the MEC; or, may be designated by the Physician Leadership Committee (PLC) as a system clinical service that has physician members and Advances Practice Professionals from each Hospital clinical specialty ... Each Department and MEC authorized clinical service, will have a chief with overall responsibility for the supervision and satisfactory discharge of assigned functions accountable to the MEC ... ."

Based on a review of facility documents, and staff interview (EMP), it was determined that Penn Highlands Clearfield facility failed to ensure 24 hour emergency care or post operative follow up care, or both were available for surgical inpatients.

Findings include:

Review of "Medical Staff Rules and Regulations of Penn Highlands Clearfield", dated August 2019, revealed "... Article IV Surgical Care ... Any emergency case takes precedence over elective surgical cases not in progress. Schedules for Saturdays, Sundays, and holidays are limited to urgent or emergencies whereby morbidity would be increased with passage of time ... There shall be an on-call schedule of physicians established and posted at each patient unit or other area where surgical patients are admitted or the communications center of the hospital to ensure that there is 24-hour emergency care or postoperative follow-up care, or both, available ... ."

Review of Penn Highlands Clearfield "Scope of Services", dated June 2020, revealed "The Department of Surgical Services is located on the third floor, east wing of the hospital ... The regular hours of OR operation are Monday through Friday, 7 am until 5:30 pm. There is an on call team available on a callback basis within a 60 minute timeframe for emergencies after hours, weekends, and holidays. (The on call services have been restricted to inpatient, post surgical patients on a case by case determination of need by the attending surgeon during the COVID-19 pandemic) ... ."

1. Surveyors requested process relative to the availability of an on-call OR team for surgical inpatients.

2. Review of OR Staff Schedules dated November 25, 2019 to May 9, 2020, was completed. During review of the schedules, it was noted that on April 28, 2020, the schedules did not indicate an OR on-call team.

3. Interview with EMP5 on August 19, 2020, revealed that that there has been no call since COVID, call is only arranged per physician order. EMP5 also stated that the OR is without limitation and they are back up and running. EMP5 continued by stating that there has been no call for evenings and weekends since April 28, 2020, and the call schedule is as requested by surgeon. EMP5 also stated that there are around 10 cases per day, and 20 cases on eye day. EMP5 continued by stating that there is no consistent call schedule and there is an option to transfer surgical inpatients, if there is no on-call team available.

4. Interview with EMP3 on August 19, 2020, stated that the lack of the OR on-call schedule is relative to the COVID emergency plan, and confirmed that there is not an on-call team available 24 hours a day for surgical inpatients.

5. Review of information provided by facility, relative to their COVID emergency plan, indicated that as of April 15, 2020, on-call OR staff will be managed to meet the needs of inpatients only, and that as of May 4, 2020, elective procedures have been resumed, with two rooms Monday-Thursday, and one room on Friday. It was also noted that the Command Center closed May 15, 2020.