Pennsylvania Department of Health
Patient Care Inspection Results

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Minimal Citation - No Harm Minimal Harm Actual Harm Serious Harm
Inspection Results For:

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Number of Residents Affected
By Deficient Practice
Initial comments:

This report is the result of a full State Licensure survey conducted on September 27, 2023, at Clarion Hospital, with documentation review concluding on October 10, 2023. It was determined that the facility was not in compliance with the requirements of the Pennsylvania Department of Health's Rules and Regulations for Hospitals, 28 Pa Code, Part IV, Subparts A and B, November 1987, as amended June 1998.

 Plan of Correction:

103.22 (b)(9) LICENSURE IMPLEMENTATION:State only Deficiency.
(9) Except for emergencies, the physicians must obtain the necessary informed consent prior to the start of any procedure or treatment, or both. Informed consent is defined in section 103 of the Health Care Services Malpractice Act (40P.S. 1301.103)

Based on a review of facility policy, medical records, and staff (EMP) interview, it was determined the facility failed to ensure an informed consent was completed in its entirety for one of three surgical records reviewed (MR3).

Findings include:

Review on October 5, 2023, of facility policy "Consent/Informed Consent", PolicyStat ID 13820431, revised September 2023, revealed "...APPENDIX A - Process A. Informed Consent Process and Completion of Consent Form. ...2. The physician or qualified practitioner must describe the proposed procedure to the patient and/or patient representative, explain why it is being recommended, and explain what will take place during the procedure. ...The consent form should then document the information that the physician or qualified practitioner told the patient and/or patient representative. A properly executed informed consent form contains at least the following: i. Name of patient and, when appropriate, the name of the patient representative; ii Name of hospital; iii. Name of procedure(s) iv. Name of physician(s)/credentialed advanced practice professional(s) performing the procedure(s) or important aspects of the procedure(s), as well as the name(s) and specific significant surgical tasks that will be conducted by practitioners other than the primary surgeon/physician...v. Risks; vi. Alternative procedure and treatments; vii. Signature of patient or the patient representative; viii. Date and time consent is obtained; ix. Statement that procedure was explained to the name of the patient and/or patient representative x. Signature of professional person witnessing the consent; and a. Name/Signature of person who explained the procedure to the patient and/or patient representative. ..."

1. Review on September 27, 2023, of MR3, revealed a gastrointestinal informed consent with the "Consenting Party" space on the form left blank.

EMP3 confirmed the above findings at the time of record review.

 Plan of Correction - To be completed: 04/11/2024

1. Review/revised Consent/Informed Consent policy.
2. Provide education to providers and staff on completion of the consent forms in its entirety.
3. Review a sample of 20 surgical consents monthly until 3 months of 100% compliance is achieved in form completion.
4. Findings will be reported to the Patient Safety Committee monthly.
5. The Director of Patient Safety and Quality will be responsible for the monitoring of the plan of correction.
103.33 (a) LICENSURE RESPONSIBILITIES:State only Deficiency.
103.33 Responsibilities

(a) The chief executive officer
shall be the official representative
of the governing body.


Based on review of facility documents and staff interview (EMP), it was determined the President (CEO) is also the CEO of a separately licensed acute care hospital. The facility failed to ensure the CEO was exclusive to Clarion Hospital.

Findings include:

Review on September 28, 2023, of the facility's "Job Code - Title: Chief Executive Officer" no review date, revealed "Job Code - Title: Chief Executive Officer ... Duties and Responsiblities Leadership: Leads, directs, and administers all operations and services of Independence Health System. Ensures quality and value, compliance with the law, ability to develop and meet goals as established by the BHS Board of Trustees, and other related activities. Oversees all personnel and resources for the health system. Exercises strategic budget and administrative control over plan, execution od [sic] plans and program management. May delegate administrative responsiblities for hospitals and provider network to Presidents of respective divisions to meet all regulatory requirements. ..."

Review on September 28, 2023, of facility "Job Description/Performance Evaluation Document" no review date, revealed "...Job Title: President, Butler and Clarion Hospital ...Reports To: CEO, Independence Health System Positions Supervises: ... and Clarion Administrative Team Members Job Summary: Reporting to the Independence Health System CEO, and in collaboration with the governing board(s) of ... and Clarion Hospital the President will provide administrative oversight to all business, administrative, strategic and executive functions of the Hospitals, consistent with and subject to the policies, procedures and objectives of the hospital ' s governing board, subject to the Independence Health CEO and reserve powers held by the IHS Board of Trustees. The President will assure an administrator is available 24/7 on site or on call. ..."

1. Review, at 2:30 PM, on September 28, 2023, of the hospital's system organizational chart revealed EMP4 is the CEO of Clarion Hospital and another individually licensed hospital.

2. EMP1-4 confirmed that EMP4 is the CEO of both individually licensed hospitals. Additionally, EMP1 confirmed that facility did not have an exception for a shared CEO.

 Plan of Correction - To be completed: 04/11/2024

1. Provide notification to DoH of a single person who is responsible for the daily operations of Clarion Hospital.
2.Review regulations prior to making administrative changes and ensure notifications are completed appropriately.
3. Periodic review of the DoH regulations over the next 3 months to ensure compliance and to prevent a reoccurrence.
4. Findings will be reported to the Patient Safety Committee monthly.
5. The Director of Patient Safety and Quality will be responsible for the monitoring of the plan of correction.
115.1 Principle

The hospital shall maintain facilities and services adequate to provide medical records which are accurately documented and readily accessible to authorized persons requiring such access and which can be readily used for retrieving and compiling information.

Based on review of facility documents, observation, and staff interview (EMP), it was determined that the facility failed to maintain facilities on the premises for medical records to be readily accessible.

Findings include:

Review, of facility contract, "SHARED SERVICES AGREEMENT" dated April 4, 2023, revealed "...2. SERVICE - Contractor will provide the services as listed within the attached Schedule A and other services as requested by Hospital and incorporated herein by an updated Schedule A (collectively, the "Shared Services"). Shared Services will be provided by Contractor's employees, subcontractors or other agents. 3. COMPLIANCE - Contractor represents and warrants that is shall provide the Shared Services in compliance with all applicable federal, state and local laws, including but not limited to statutory, regulatory and common law... Schedule A...The maintenance, administration, management and/or provision of the following services: Medical Records Services ... ."

Review, of Management Job Description for OTH1 revealed, "DIRECTOR HEALTH INFORM MGMT ... Job Summary: Responsible for the development, management, and direction of the Health Information Management Departments of ... and Clarion Hospitals that is service-oriented, receptive to the challenges and requirements of a changing health care environment and supportive of the mission and values ... The Director of Health Information Management is responsible for planning, operations efficiency and effectiveness, fiscal management's, departmental stewardship, electronic systems efficiency and effectiveness, compliance, patient, staff and provider satisfaction and safety, and timely and accurate reporting to management. Provides technical support on operations issues, establishes and maintains medical record and related systems and operation consistent with overall administrative policies, goals and objectives, as well as, with medical, ethical and legal requirement of the health care delivery system. ..."

1. A facility tour was conducted at approximately 11:00 AM on September 26, 2023, at the facility. When asked where medical records was located, EMP1 indicated the medical records service is located at a separate individually licensed hospital.

When asked if there was a full or part time person that works within the Medical Records department at Clarion Hospital, EMP2 confirmed "they're contracted ...". EMP2 further indicated a courier transports paper records between the two individually licensed entities.

 Plan of Correction - To be completed: 04/11/2024

1. The Medical Records Dept. will be in the approved DoH space.
2. An employee will be available to address medical record requests/accessibility Monday to Friday, 0800-1600, excluding holidays and will be trained on processing the requests for medical records.
3. Employee will monitor the number of walk in medical record requests for a period of 3 months.
4. Findings will be reported to the Patient Safety Committee monthly.

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