Effective October 1, 2018
Any clinical laboratory that performs waived tests only is exempt from state licensure requirements and state surveys. Any such laboratory will still be required to obtain a Clinical Laboratory Improvement Amendments (CLIA) certificate as required by the Centers for Medicare and Medicaid Services (CMS).
All laboratories that perform non-waived testing will still be required to follow the rules and regulations of the Department and CMS.
CLIA, Clinical Laboratory Improvement Amendment, requires every facility that tests human specimens for the purpose of providing information for the diagnosis, prevention or treatment of any disease or the assessment of health of a human being, to meet certain federal requirements. If a facility performs tests for any of the above mentioned purposes, it is considered, under the law, to be a laboratory.
A facility may apply for one of four CLIA certificate types: waived, PPM (Provider-performed microscopy), compliance or accreditation. Both compliance and accreditation certificates allow laboratories to perform moderate and/or high complexity testing. A waived certificate allows for tests, categorized as waived only, to be performed. With a Certificate of PPM, the participant may perform tests categorized as PPM testing (microscopy) and waived. Laboratories wishing to apply for a CLIA certificate, specific to testing-type, should submit to the CLIA, State Agency, a form CMS #116, also referred to as a CLIA application. Test categorization and the form CMS #116 may be found on the CLIA website at www.CMS.gov/CLIA. This form is accompanied by instructions for completion. Laboratories requesting a Certificate of Accreditation must provide evidence of accreditation for the laboratory by an approved accreditation organization.
Laboratory directors of facilities, performing PPM, moderate or high complexity tests, must meet specific education, training and/or experience, as defined under subpart M (42 CFR Part 493) of the CLIA requirements. These qualifications may be found on www.CMS.gov/CLIA.
At a minimum, a director servicing a PPM should submit a copy of his current Alabama Medical License. The qualifications are different for directors servicing moderate or high complexity laboratories. Please see the above referenced website for credentials specific to the type testing performed.
After completing the form CMS #116 (CLIA application) in its entirety, please submit to the CLIA, State Agency for processing. This application may be mailed to: 201 Monroe Street, Suite 700, Montgomery, Alabama 36104; emailed to the Administrative Support Assistant at Tamika.Shepherd@adph.state.al.us; or faxed to CLIA at 334-206-5303. Under routine conditions, please allow approximately 2-3 weeks for processing. All applicable sections of the application must be completed for processing. Incomplete applications will be returned to the facility.
After processing of the application by the State Agency, a fee remittance coupon will be issued by the electronic system (it is important to have the correct mailing address on file). This fee coupon will indicate the laboratory’s CLIA identification number and the amount necessary for the certification, and if applicable the compliance survey or validation (accredited labs) fee. A laboratory is not allowed to perform patient testing, until a registration certificate is received. An on-site inspection of compliance laboratories will be conducted at a later date, following CLIA registration.
Changes to CLIA Certifications
Waived laboratories may request changes (i.e. change of director, address, hours of operation) to the CLIA certification by notification on letterhead. PPM, compliance and accredited laboratories should submit changes on the form CMS 116, signed by the laboratory director and submit to the state agency.
Replacement certificates may be generated upon request; but under specific circumstances. CLIA certificates are not generated by the state agency; however the state agency is authorized to make requests for replacement certificates, when certain conditions are met.
Any questions or concerns not addressed on the CLIA website or www.alabamapublichealth.gov regarding CLIA certifications may be addressed by the State Agency at 334-206-5120.
Page last updated: July 23, 2018