Overview, Contacts & FAQs

CLIA Mission Statement

The mission of the New Mexico CLIA program is to ensure that the highest quality of laboratory testing is performed in New Mexico through education and enforcement of federal regulations.

A Brief History of CLIA

CLIA began in the late 1960's when problems arose in the cytology laboratories that read PAP smears. The personnel in these laboratories were overworked and had a very high error rate. Many women suffered or died because the cytologists had missed the early stages of cancer on the PAP smears. In 1967, the Clinical Laboratory Improvement Amendment was passed and the first laboratory regulations were born. In 1988, a second amendment was passed but did not go into effect until 1992 when the new regulations were approved.

Purpose of CLIA

The purpose of CLIA is to set minimum standards for all laboratories to follow and to determine if laboratories are achieving those standards.

CLIA Contact Information

Health Facility Licensing and Certification
5301 Central Ave NE Suite 400
Albuquerque, NM 87108

Phone: (505) 222-8646
Fax: (505) 841-5834

Frequently Asked Questions

Who needs a CLIA certificate?

Any person or facility that performs laboratory tests on human specimens for the purpose of diagnosis and/or treatment is required by federal law to have a CLIA certificate. Medicare requires the CLIA certificate number before any claims can be processed. Certificates must be renewed every two years for as long as testing is being performed. Changes in ownership, location, and type of testing performed must be reported to the following agency within 30 days of the change:

Health Facility Licensing and Certification
5301 Central Ave NE Suite 400
Albuquerque, NM 87108

Phone: (505) 222-8646

Requests for applications must be in writing and
must be sent to the above address.

It is the facility's responsibility to make sure that the level of testing performed matches the facility's certificate type. Reimbursements by Medicare may be denied if the test submitted does not match the certificate.

What certificate types are available?

Certificate of Waiver

These tests have been approved by the FDA for home use and require very little training to perform. The only requirements for this type of testing are that the manufacturer's instructions are followed exactly and that there is documentation that the testing personnel have been trained to perform the test. Proficiency testing is not required for this level of testing but the quality of the tests performed must be evaluated at least twice a year.

Click here for a current list of waived tests.

Provider Performed Microscopy

These are tests performed by a health care provider such as a doctor, physician's assistant, or nurse practitioner. These tests include: microscopic sediment analysis, wet preps, KOH preps, and other microscope based procedures. All waived tests may be performed with this level of certificate with the same requirements as a certificate of waiver. Proficiency testing is not required for this level of testing but the quality of the tests performed must be evaluated at least twice a year.

Click here for a complete test list.

Certificate of Compliance

Tests performed under this type of certificate have been classified as moderate or high complexity and have regulations that are more stringent. Facilities performing moderate or high complexity testing must be enrolled in an approved Proficiency Testing program for each regulated analyte. Analytes that do not have a Proficiency Testing program available must be evaluated at least twice a year. Each facility must establish a Quality Assurance program that includes quality control, personnel policies, patient test management, and proficiency testing. These facilities are inspected every two years to ensure compliance with federal regulations.

For more detailed information go to:

The Centers for Medicare & Medicaid Services (CMS)   or

The Center for Disease Control

Certificate of Accreditation

Facilities with this type of certificate have opted to have a HCFA approved accrediting agency perform the biannual inspections instead of HCFA for an additional fee. These facilities must follow the accrediting agency's guidelines in addition to the federal regulations. Occasionally, a validation inspection is conducted to evaluate the accrediting agency inspection process.

What are the requirements for testing personnel?

For tests classified as waived or moderately complex, testing personnel must have at least a high school diploma or G.E.D. and documentation of training before performing tests.

For tests classified as high complexity, testing personnel must have an associate of science degree or higher and documentation of training before performing tests.

All personnel must be evaluated within six months of hire and annually after that.

What kinds of facilities are subject to inspections?

All facilities performing laboratory testing are subject to inspection by HCFA. Only Certificate of Compliance laboratories have routine inspections. Complaint investigations are performed as needed.

What is the Survey or Inspection Process?

The surveyor will schedule routine surveys within six months of the certificate expiration date. Complaints and revisit surveys are always unannounced. The surveyor will review all documents related to laboratory testing including but not limited to procedure manuals, test records, personnel files, and patient records. Failure to voluntarily provide this information may result in termination of your CLIA certificate and Medicare reimbursements. If the surveyor finds condition level or severe deficiencies, the facility's CLIA number may be terminated. Except in rare cases, facilities are given the opportunity to correct all deficiencies within a specified period before termination occurs. Standard or minor deficiencies must be corrected within a reasonable period not to exceed 12 months. Assistance is always available to facilities.

Does New Mexico have any state regulations for laboratories or laboratory personnel?

No. Currently, there are no state regulations for laboratories or laboratory personnel.

CLIA regulations state that only an authorized person may order tests.
What does this mean?

CLIA defines an authorized person as someone that has specific authorization from the state in which the test is performed. New Mexico does not currently have any statutes that define an "authorized person". However, the Medicare regulation specifies that the "authorized person" must be a doctor with a current state medical license. Other sources of information are the New Mexico Board of Medical Examiners, New Mexico Board of Pharmacy, and the New Mexico Board of Nursing.

Why has my Medicare claim for reimbursement been denied?

There can be several reasons for denial:

1. The CPT code for the test is incorrect. Make sure that you are not billing for a different test. For example, CPT codes for waived tests are different from the codes for the same analyte using a moderately complex method.
   
2. You are billing for a test that is not authorized by your CLIA certificate. For example, if you possess a Certificate of Waiver, you cannot bill for a moderately complex test. Make the appropriate changes to your certificate.
   
3. You do not have a current CLIA certificate. Check the expiration date on your certificate if you have one. If you do not have a certificate, apply for one as soon as possible.
   
4. Medicare also requires ICD-9 codes. Make sure that the appropriate ICD-9 was submitted.

Please call our offices,
if you have a question you would like to see added to this list:

(505) 222-8646