10 Colo. Code Regs. § 2505-10-8.561
Current through Register Vol. 47, No. 16, August 25, 2024
Section 10 CCR 2505-10-8.561 - REQUIREMENTS FOR CERTIFICATIONA. Participating health agencies must be certified by the Colorado State Department of Health in accord with federal regulations 42 CFR 431.610, October 1991 edition. No amendments or later editions are incorporated. Copies are available for inspection and available at cost at the following address: Manager, Health and Medical Services, Colorado Department of Social Services, 1575 Sherman Street, Denver, Colorado 80203-1714. Certified health agencies performing laboratory services must be certified as a clinical laboratory in accordance with regulations cited at 8.660 through 8.666. Certified health agencies must obtain a certificate of waiver from the Health Care Financing Administration or its designated agency if the health agency only performs waivered tests as defined by Clinical Laboratory Improvement Amendments of 1988 (CLIA).B. All certified health agencies and staff shall comply with all applicable federal, state and local regulations concerning the operation of such clinic services. These include but are not limited to the following: certification, organization, staffing, licensure of personnel, service provision responsibilities, maintenance of health records and program evaluation.C. Termination of certification or non-renewal of certification will be determined by the Colorado State Department of Health.