Alabama

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 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 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 CLIAAlabama@adph.state.al.us; or faxed to CLIA at 334-206-5254. 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.

Chapter 420-5-8. Independent Clinical Laboratories

“(2) Application.

(a) Application. An application for license or renewal of license shall be made on forms provided by the State Board of Health and shall contain such information as the Board may require.

(b) Fee. Each application for license shall be accompanied by a fee as mandated by statute. No fee shall be refunded. Fees shall be paid by cash, check or money order made payable to the Alabama Department of Public Health.”

Application: https://www.alabamapublichealth.gov/providerstandards/assets/icl_initial.pdf

In addition to the information requested within the application, the following must also be submitted:

1. A completed license application and $240 application fee. Application fees are not refundable.
2. Organizational documents such as: Articles of Incorporation, LLC Agreement, Partnership Agreement, or Statementof Sole Proprietorship under which the facility will operate. A copy of the registration to conduct business in Alabama must accompany this application if the entity was established in a state other than Alabama.
3. Qualifications and licensure information regarding the medical director. Following review of the application, a copy of the application will be forwarded to the Division of Health Care Facilities, Laboratory Unit. A staff member from the Division of Health Care Facilities Laboratory Unit may contact you regarding an on-site licensure visit to determine if the facility meets minimum requirements for a state license.

Due to workload volume, application review takes a minimum of thirty days. An onsite survey (if required) could add considerable time to completion of the licensure process.

Online Access to CLIA Certificates: CMS is now making CLIA certificates available online at no cost via the QCOR Lookup Tool.  All certificates generated after September 27, 2023 should be available for download.  Click HERE to access the Tool and choose “CLIA Laboratory Lookup” from the left menu bar (2nd option from the top).  When you click the entry for the laboratory, a box containing the laboratory information and a link to the certificate will pop up in a new window.