Initial Comments:
Based on the findings of an unannounced Medicare complaint survey conducted onsite January 18, 2024, Sayre Health Center was identified to have the following standard level deficiencies and was determined to be in substantial compliance with the following requirements of 42CFR, Part 405, Subpart X and 42CFR Part 491.1-491.11 Subpart A, Conditions for Certification: Rural Health Clinics.
Plan of Correction:
491.6(b) and (b)(1) STANDARD
PHYSICAL PLANT AND ENVIRONMENT
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491.6(b) Maintenance:
The clinic . . . has a preventive maintenance program to ensure that:
(1) All essential mechanical, electrical and patient-care equipment is maintained in safe operating condition;
Observations:
Based on a review of clinic policies/procedures, the clinic failed to have a preventative maintanence program in place to ensure that all essential mechanical, electrical and patient-care equipment is maintained in safe operating condition.
Findings include:
A review of clinic policies/procedures was conducted on January 18, 2024 at approximately 10:45 am revealed the clinic has no policies/procedures for a preventative maintanence program to ensure that all essential mechanical, electrical and patient-care equipment is maintained in safe operating condition.
An interview with the executive director conducted on January 18, 2024 at approximately 12:00 pm confirmed the above findings.
Plan of Correction:1. Sayre Health Center has implemented a Preventive Maintenance Program to regularly inspect and maintain essential equipment, ensuring safe operating conditions and preventing future issues.
2. The facility will monitor the performance of the Preventive Maintenance Program through regular audits, equipment maintenance logs, and feedback from staff to ensure sustained effectiveness and adherence to established protocols.
3. The facility has designated the Medical Director to monitor the continued implementation of the plan of correction, overseeing adherence to maintenance schedules and addressing any deviations or deficiencies promptly.
491.7(a)(1) and (b)(3) STANDARD
ORGANIZATIONAL STRUCTURE
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491.7(a) Basic requirements.
(1) The clinic . . . is under the medical direction of a physician, and has a health care staff that meets the requirements of § 491.8.
(b) Disclosure. The clinic . . . discloses the names and addresses of: . . .
(3) The person responsible for medical direction.
491.2 Definitions. As used in this subpart, unless the context indicates otherwise:
Physician means the following:
(1) As it pertains to the supervision, collaboration, and oversight requirements in sections 1861(aa)(2)(B) and (aa)(3) of the Act, a doctor of medicine or osteopathy legally authorized to practice medicine or surgery in the State in which the function is performed; and
(2) Within limitations as to the specific services furnished, a doctor of dental surgery or of dental medicine, a doctor of optometry, a doctor of podiatry or surgical chiropody or a chiropractor (see section 1861(r) of the Act for specific limitations).
Observations:
Based on a review of clinic administrative documentation and interview with the executive director, the clinic failed to immediately notify the appropriate state agency (SA) of a change in the physician responsible for the clinic's medical direction.
Findings include:
A review of clinic administrative documentation was conducted on January 18, 2024 at approximately 10:50 am revealed there was no documentation of immediate notification to the appropriate SA for a change in physician responsible for medical direction that included the name, address, and phone number of the new medical director and evidence that the physician is licensed to practice in the State in which the Federally Qualified Health Center is located.
An interview with the executive director on January 18, 2024 at approximately 12:00 pm confirmed no notification of medical director change was sent to the appropriate SA.
Plan of Correction:1. Sayre Health Center has established clear Procedures for Immediate Notification to the State Agency (SA) of any changes in the physician responsible for medical direction, ensuring timely and compliant reporting.
2. The facility will monitor the performance of the Procedures for Immediate Notification through regular audits of physician credentials and notification procedures, ensuring that any changes are promptly communicated to the SA and that documentation is accurate and up-to-date.
3. The facility has designated the Human Resources Director to monitor the continued implementation of the plan of correction, overseeing adherence to notification procedures, providing staff training as needed, and conducting periodic reviews to ensure compliance.
4. The Human Resources Director will be responsible for monitoring outcomes of the Procedures for Immediate Notification, including timely reporting of physician changes to the SA, accuracy of documentation, and compliance with regulatory requirements.
491.8(b)(2), 491.8(c)(1)(i), and 491.9(b)(1), (2), (4) STANDARD
STAFFING AND STAFF RESPONSIBILITIES
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491.8(b) Physician responsibilities. The physician performs the following:
(2) In conjunction with the physician assistant and/or nurse practitioner member(s), participates in developing, executing, and periodically reviewing the clinic's . . . written policies and the services provided to Federal program patients.
491.8(c) Physician assistant and nurse practitioner responsibilities.
(1) The physician assistant and the nurse practitioner members of the clinic's . . . staff:
(i) Participate in the development, execution and periodic review of the written policies governing the services the clinic . . . furnishes;
§ 491.9(b) Patient care policies . . .
(1) The clinic's … health care services are furnished in accordance with appropriate written policies which are consistent with applicable State law.
(2) The policies are developed with the advice of a group of professional personnel that includes one or more physicians and one or more physician assistants or nurse practitioners. At least one member is not a member of the clinic . . . staff.
(4) These policies are reviewed at least biennially by the group of professional personnel required under paragraph (b)(2) of this section and reviewed as necessary by the clinic...
Observations:
Based on a review of Professional Advisory Committee (PAC) documentation, clinic policies/procedures, and an interview with the executive director, the clinic failed to have appropriate written policies/procedures that were developed and reviewed at least biennually with the advice of a group of professional personnel that includes one or more physicians and one or more physician assistants or nurse practitioners with at least one member who is not a member of the clinic staff.
Findings include:
A review of PAC documentation was conducted on January 18, 2024 at approximately 10:00 am revealed the following:
1. Clinic patient care policies consisted only of general outlines of services provided by the clinic and did not contain any patient related policy and procedure manuals.
2. Clinic did not have any policies pertaining to a professional advisory committee.
3. Clinic does not have a professional advisory committee.
An interview with the executive director was conducted on January 18, 2024 at approximately 12:00 pm. The executive director stated clinic does not have a professional advisory committee and all policies are written, reviewed, and approved by the Board of Directors.
Plan of Correction:1. Sayre Health Center has established robust policies and procedures for the Professional Advisory Committee (PAC) and clinic patient care, ensuring thorough documentation and adherence to regulatory standards, while also forming the actual PAC members according to policy guidelines to prevent recurrence.
2. The facility will monitor the performance of PAC policies and patient care procedures through regular audits, staff training sessions, and feedback mechanisms to ensure sustained adherence and compliance with established protocols.
3. The facility has designated the Medical Director to monitor the continued implementation of the plan of correction, overseeing compliance with PAC policies, patient care procedures, and documentation standards.
4. The Medical Director will be responsible for monitoring outcomes of the PAC policies and patient care procedures, including effectiveness of committee functions, adherence to policies, and quality of patient care provided at Sayre Health Center.
491.9(b)(3)(i) and (ii) STANDARD
PROVISION OF SERVICES
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491.9(b) Patient care policies.
(3) The policies include:
(i) A description of the services the clinic . . . furnishes directly and those furnished through agreement or arrangement.
(ii) Guidelines for the medical management of health problems which include the conditions requiring medical consultation and/or patient referral, the maintenance of health care records, and procedures for the periodic review and evaluation of the services furnished by the clinic . . .
Observations:
Based on a review of clinic patient care policies/procedures, the clinic failed to provide guidelines for the maintenance of health care records and procedures for the periodic review and evaluation of the services furnished by the clinic.
Findings include:
A review of clinic patient care policies/procedures was conducted on January 18, 2024 at approximately 11:40 am revealed patient care policies/procedures, guidelines for medical management of health problems did not contain any documentation for the maintenance of health care records, and procedures for the periodic review and evaluation of the services furnished by the clinic.
An interview with the executive director conducted on January 18, 2024, confirmed the above findings.
Plan of Correction:1. Sayre Health Center has revised its clinic patient care policies/procedures with a detailed Addendum addressing guidelines for medical management of health problems, specifically focusing on maintenance of health care records and procedures for periodic review and evaluation, to prevent recurrence of previous deficiencies.
2. The facility will monitor the performance of the revised policies/procedures through regular audits, staff training sessions, and quality assurance reviews to ensure sustained compliance and effectiveness in maintaining health care records and conducting periodic evaluations of clinic services.
3. The facility has designated the Medical Director to monitor the continued implementation of the plan of correction, overseeing adherence to the revised policies/procedures, conducting ongoing staff training, and addressing any identified issues promptly.
4. The Medical Director will be responsible for monitoring outcomes of the revised policies/procedures, including the accuracy and completeness of health care records, the effectiveness of periodic evaluations, and overall improvement in the quality of services furnished by Sayre Health Center.
491.9(b)(3)(iii) STANDARD
PROVISION OF SERVICES
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491.9(b) Patient care policies.
(3) The policies include:
(iii) Rules for the storage, handling, and administration of drugs and biologicals.
Observations:
Based on a review of clinic patient care policies, the clinic failed to include policies that include rules for the storage, handling, and administration of drugs and biologicals.
Findings include:
A review of clinic patient care policies was conducted on January 18, 2024 at approximately 11:40 am revealed the clinic patient care policies did not contain any documentation regarding the rules for the storage, handling, and administration of drugs and biologicals.
An interview with the executive director conducted on January 18, 2024 at approximately 12:00 pm confirmed the above findings.
Plan of Correction:1. Sayre Health Center has implemented an Addendum to the clinic patient care policies/procedures, providing detailed guidelines for the storage, handling, and administration of drugs and biologicals, including regular training sessions and updates to ensure staff compliance and prevent recurrence of previous issues.
2. The facility will monitor the performance of the Addendum through routine inspections of drug storage areas, audits of medication administration practices, and tracking of inventory management processes to ensure sustained adherence to guidelines and regulatory standards.
3. The facility has designated the Medical Director to monitor the continued implementation of the plan of correction, overseeing staff training on drug handling protocols, conducting periodic audits, and addressing any identified deficiencies promptly.
4. The Medical Director will be responsible for monitoring outcomes of the Addendum implementation, including compliance with drug storage and administration guidelines, reduction in medication errors, and improvement in patient safety related to drug management practices at Sayre Health Center.
491.10(a)(1)-(2) STANDARD
PATIENT HEALTH RECORDS
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491.10(a) Records system.
(1) The clinic . . . maintains a clinical record system in accordance with written policies and procedures.
(2) A designated member of the professional staff is responsible for maintaining the records and for insuring that they are completely and accurately documented, readily accessible, and systematically organized
Observations:
Based on a review of the clinic's clinical record system policies/ procedures, the clinic failed to maintain policies/procedures for the clinical record system and to designate member(s) of the professional staff who is responsible for maintaining the records and for insuring that they are completely and accurately documented, readily accessible, and systematically organized.
Findings include:
A review of the clinic's clinical record system policies/procedures conducted on January 18, 2024 at approximately 11:50 am revealed the clinic did not have any written policies/procedures to maintain policies/ procedures for the clinical record system and to designate member(s) who of the professional staff is responsible for maintaining the records and for insuring that they are completely and accurately documented, readily accessible, and systematically organized.
An interview with the executive director on January 18, 2024 at approximately 12:00 pm, confirmed the above findings.
Plan of Correction:1. Sayre Health Center has implemented an Addendum to the clinic's clinical record system policies/procedures, detailing protocols for record maintenance and designating responsible staff members, coupled with regular training sessions and audits to ensure compliance and prevent recurrence of previous deficiencies.
2. The facility will monitor the performance of the Addendum through regular audits of clinical record maintenance practices, staff training sessions, and feedback mechanisms to ensure sustained adherence to documentation standards and systematic organization of records.
3. The facility has designated the Medical Director to monitor the continued implementation of the plan of correction, overseeing staff training on record maintenance protocols, conducting periodic audits, and addressing any identified deficiencies promptly.
4. The Medical Director will be responsible for monitoring outcomes of the Addendum implementation, including the completeness, accuracy, and accessibility of clinical records, ensuring improved record-keeping practices and compliance with regulatory standards at Sayre Health Center.
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