Clinical Laboratory Improvement Act (CLIA)
How To....
Apply for a CLIA Certificate in New Mexico
1. Send a letter requesting an application packet to:
CLIA Program
5301 Central Ave NE
Suite 400
Albuquerque, NM 87108
Fax: (505) 841-5834
or
Visit the CMS CLIA Website, www.cms.hhs.gov/clia, and download the Application Form 116.
2. Complete the application and a detailed list of tests that will be performed at the facility.
Please include the name of the test, test system used, and the CPT code used for billing. This information will ensure that the correct CLIA certificate will be issued. Please include a form of address verification such as incorporation documents, utility bills, lease agreements or business license.
3. Send the completed application packet to:
CLIA Program
5301 Central Ave NE
Suite 400
Albuquerque, NM 87108
Fax (505) 841-5834
DO NOT SEND MONEY WITH THE APPLICATION
All checks will be returned. CMS in Baltimore will bill the facility for all fees.
4. You will be notified by phone or by mail if the application is incomplete or inaccurate.
5. Once the fees have been paid, CMS will issue the appropriate certificate.
Renew a Certificate
CMS in Baltimore will issue a bill for renewal as follows:
Certificate of Waiver |
6-months before the expiration date |
Certificate of Provider Performed Microscopy |
6-months before the expiration date |
Certificate of Accreditation |
6-months before the expiration date |
Certificate of Compliance |
Survey fee: 12-months before the expiration date Certificate fee: after the survey has been completed |
CMS will mail the new certificate approximately one month prior to the expiration date.
Report Changes
All changes in laboratory directors, addresses and phone numbers, and ownership, must be reported to the CLIA Program within 30 days.
Why is this important?
- Failure to report address changes may result in termination of the CLIA certificate for non-payment of fees. Laboratories have up to 6 months after the termination to reactivate without losing Medicare or Medicaid reimbursements.
- Failure to report a change in ownership may delay any refunds due from the CLIA program since the U.S. Treasury will not issue a check if the tax identification numbers (EIN) are incorrect.
- Failure to report a change in laboratory directors will result in the issuance of the CLIA certificate with the wrong name.
How do I report changes?
- For waived certificates, any written format is acceptable such as fax, email, or regular mail.
- For all other certificate types, the laboratory must complete CMS form 116. If reporting a new laboratory director, also include documentation of the laboratory director’s qualifications such as medical license and resume.
- Changes in ownership require additional forms. Contact the New Mexico CLIA program for these forms.
How do I know the changes have been made?
- Upon request, the New Mexico CLIA program will send a print screen of the changes to you. For this service, you must provide a valid email address or fax number. Print screens will not be sent via regular mail.
- You can request a replacement certificate. However, it will take up to 3 weeks to receive a replacement and if your certificate expires within 6 months, your laboratory is not eligible to receive a new certificate. All changes must be sent to:
CLIA Program
5301 Central Ave NE
Suite 400
Albuquerque, NM 87108
Fax (505) 841-5834
Email: julie.aragon@state.nm.us
