Division of Health Provider
Clinical Laboratory Improvement Amendments (CLIA) Program
The Clinical Laboratory Improvement Amendments (CLIA) program oversees laboratories that test human specimens for diagnostic purposes. These include hospital laboratories, stand-alone diagnostic labs, and doctors' offices.
Frequently Asked Questions about the CLIA Program
Contact Person: Mary Jo Roue', Director, (803) 545-4203.
- CLIA - SOM (State Operations Manual) Reference
- Appendix C - Survey Procedures for the Application of Conditions for Coverage for Independent Laboratories -- Interpretive Guidelines (42 CFR 493)
- Appendix Q - Guidelines for Determining Immediate and Serious Threat to Patient Health and Safety
Health Insurance Benefit (HIB) Program
The Health Insurance Benefit (HIB) Program processes initial applications for Medicare certification, and conducts recertification surveys of Hospitals, Home Health Agencies, Portable X-Ray, Rehabilitation Agencies, Rural Health Clinics, End Stage Renal Disease Facilities, Comprehensive Outpatient Rehabilitation Facilities, Ambulatory Surgery Centers, Hospices, and Swing Bed Units of Hospitals.
The HIB program also processes initial applications for Medicare Certification for Community Mental Health Centers, Prospective Payment System (PPS) exempt status for psychiatric and rehabilitation units in hospitals, PPS exempt status for long term care hospitals and hospital within a hospital.
Contact Person: Mary Jo Roue', Director, (803) 545-4203.
- Health Insurance Benefits HOSPITALS Regulations: Conditions of Participation for Hospitals; 42CFR Part 482 Interpretive Guidelines:
- Hospitals SOM Appendix A; Psychiatric Hospitals SOM Appendix AA; Interpretive Guidelines and Investigative Procedures for Responsibilities of Medicare Participating Hospitals in Emergency Cases (COBRA - EMTALA) SOM Appendix V; Critical Access Hospitals: Conditions of Participation; 42CFR Part 485 Subpart F
- HOME HEALTH AGENCIES Regulations: Conditions of Participation: Home Health Agencies; 42CFR Part 484
- Interpretive Guidelines: SOM Appendix B
- PORTABLE X-RAY Regulations: Conditions for Coverage: Portable X-Ray Services;
42CFR Part 486 Subpart C
- Interpretive Guidelines: SOM Appendix D
- REHABILITATION AGENCIES Regulations: Conditions of Participation for Clinics, Rehabilitation Agencies & Public Health Agencies
as Providers of Outpatient Physical Therapy & Speech Language Pathology; 42CFR Part 485, Subpart H
- Interpretive Guidelines: SOM Appendix E
- RURAL HEALTH CLINICS (RHC) Regulations: Rural Health Clinic: Conditions for Certification; 42 CFR Part 491 Subpart A
- Interpretive Guidelines: SOM Appendix G
- END STAGE RENAL DISEASE (ESRD) Regulations: Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD)Services; 42 CFR 405 Subpart U
- Interpretive Guidelines: SOM Appendix H
- COMPREHENSIVE OUTPATIENT REHABILITATION FACILITIES (CORF) Regulations: Conditions of Participation: Comprehensive Outpatient Rehabilitation Facilities; 42 CFR 485.50 Subpart B
- Interpretive Guidelines: SOM Appendix K
- AMBULATORY SURGERY CENTERS (ASC) Regulations: Ambulatory Surgical Services; 42CFR Part 416
- Interpretive Guidelines: SOM Appendix L
- HOSPICES Regulations: Hospice Care; 42CFR Part 418
- Interpretive Guidelines; SOM Appendix M
- SWING BED UNITS Regulations: Conditions of Participation for Hospitals; 42CFR Part 482; Subpart E: 82.66-Special requirements for hospital providers of long-term care services.
- Interpretive Guidelines: SOM Appendix T
- COMMUNITY MENTAL HEALTH CENTERS Regulations:
- Code of Federal Regulations; Social Security Act and Public Health Service Act