Certification of Certain Health Facilities

Purpose and scope.

This subpart defines the conditions for rural health clinics and FQHCs to qualify for Medicare and Medicaid reimbursement.

Patient health records.

Rural health clinics and FQHCs must maintain a clinical record system, ensure confidentiality, and retain records for at least six years.

Program evaluation.

Clinics and centers must conduct a biennial evaluation of their total program, including service utilization, clinical records, and policies, to ensure quality and compliance.

Emergency preparedness.

Rural Health Clinics and Federally Qualified Health Centers must maintain an emergency preparedness program including a plan, policies, communication, and training.

Definitions.

This section provides definitions for terms used in the subpart, including clinical staff roles and facility types.

Certification procedures.

Rural health clinics must follow specific Medicare certification procedures and are deemed to meet Medicaid standards upon Medicare certification.

Compliance with Federal, State and local laws.

Clinics and their staff must maintain compliance with all applicable laws, including facility and personnel licensure requirements.

Location of clinic.

This provision establishes the geographic and population-based criteria for the certification of Rural Health Clinics and Federally Qualified Health Centers.

Physical plant and environment.

This provision mandates that clinics maintain a safe physical environment, including preventive maintenance for equipment and proper storage for medical supplies.

Organizational structure.

This provision requires clinics to maintain clear lines of authority, medical direction by a physician, and disclosure of ownership information.

Staffing and staff responsibilities.

This provision defines the required composition of the health care staff, including physicians and mid-level practitioners, and outlines their specific clinical and administrative responsibilities.

Provision of services.

This provision outlines the requirements for patient care policies, direct services, laboratory standards, and emergency procedures in clinics.