Policyholder Services

We have applied for a CLIA waiver in order to perform simple laboratory tests that are on the waiver list. Will OMIC cover our practice for performing these tests?

The Clinical Laboratory Improvement Amendments (CLIA) law, passed by Congress in 1988, establishes quality standards for all laboratory testing to ensure the accuracy, reliability, and timeliness of patient test results. It specifies that laboratory requirements be based on the complexity of the tests performed and allows for waiver from regulatory oversight if the tests meet certain requirements. Waived tests are defined as “simple laboratory examinations and procedures that are cleared by the Food and Drug Administration (FDA) for home use; employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; or pose no reasonable risk of harm to the patient if the test is performed incorrectly.” While tests approved by the FDA for home use automatically qualify for CLIA waiver, waiver of professional use versions of such tests requires review and approval.

Subject to other standard provisions of the policy, OMIC will extend coverage for ophthalmic-related, CLIA-waived tests the practice conducts for its patients, provided that the staff involved in collecting, processing, and analyzing samples are properly trained and qualified and that the activities fall within their lawful scope of service.  The practice should also ensure they have the necessary equipment, sterile environment, and appropriate safety protocols in place for the laboratory services they will provide.