Clinical Laboratory Improvement Act (CLIA)

CLIA

The objective of the CLIA program is to ensure quality laboratory testing. Although all clinical laboratories must be properly certified to receive Medicare or Medicaid payments, CLIA has no direct Medicare or Medicaid program responsibilities. The program is administered by the federally regulated Centers for Medicare & Medicaid Services (CMS) agency.

The CMS CLIA website has information such as Regulations, forms, brochures, etc.

State Operations Manual, Appendix C – Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services (Federal Program):

Applications & Change of Ownership:

Requests for New Provider Applications (CMS116) or Applications should be submitted via mail, email or fax to the ADH Health Facility Services office, listed below.

New Provider Application: This packet will contain forms to begin the process to become Medicare Certified and must be submitted to Health Facility Services.
Change of Ownership Application: For existing Providers who need to notify Health Facility Services of a change in ownership. This packet will contain forms to begin the CHOW approval process.

Completed applications for New Providers or Change of Ownership should be submitted to Health Facility Services via mail, email or fax.

View CLIA Frequently Asked Questions.