What does CLIA Waived Mean?
July 11, 2010 in Employee Drug Testing Information
CLIA refers to Clinical Laboratory Improvement Amendments. These amendments were passed by the Congress way back in 1988. These laws stipulate that laboratory testing procedures should ensure timeliness, accuracy and dependability irrespective of the location of the tests.
What is a CLIA waiver?
Every laboratory and home test has its own unique requirements. Certain tests can be highly complex and may require specialized equipment. If these tests satisfy certain conditions they can be exempt or waived from all regulatory procedures. In other words, these tests are cleared by FDA and can be performed at home. Most of these tests are very simple to carry out and use standardized equipment, which makes chances of an inaccuracy impossible. Such tests are referred to as a CLIA waived.
Which tests are CLIA waived?
There are specific tests which have been CLIA waived. These are:
Tests performed for urinalysis using a tablet or a dipstick: These include tests to ascertain the presence of protein, urobilinogen, hemoglobin, bilirubin, nitrite, pH, glucose levels, leukocytes, ketone, specific gravity etc.
– Pregnancy tests: There are many home kits available these days, which make it easy for a woman to determine if she is pregnant.
– Occult blood of the fetus
– Non-automated method of estimating the rate of erythrocyte sedimentation
– Ovulation tests: This involves performing color comparisons visually to ascertain luteinizing hormones
– Non-automated methods of detecting copper sulfate in hemoglobin
– Using glucose measuring mechanisms to ascertain blood glucose levels
Things to keep in mind
In order to have a particular laboratory test get CLIA waived, you need a certificate from the FDA. This certificate has to be issued from the Secretary. If you already have a certificate and it is about to expire, you need to get it renewed. The certificate can be rejected for renewal if your laboratory fails to comply with the regulations stipulated as per the CLIA law. A CLIA waived test should be so easy and simple to perform that even if it is done improperly it does not harm the patient in any manner. In cases where the laboratory application for a CLIA waiver has been disapproved the Secretary will issue a notice of the same. From that date onwards, the certificate will continue to be valid for a period of 60 days or longer if the second application is made in a timely manner.
Factors considered for a CLIA waiver
There are several aspects that are taken into consideration when treating a laboratory test as CLIA waived. Various factors like the quality control being used and method of calibration, processes and examination procedures in use, interpretation mechanisms, how much of independent judgment is required, training needed for instrument usage and operation as well as other associated factors are assessed before passing a test as CLIA waived. Regular inspections will also be conducted by the Secretary to ascertain that the procedures of the laboratory are in strict compliance with the stipulations as per CLIA law. Laboratories, which are accredited as per CLIA laws will be inspected as and when deemed necessary by the Secretary. Those laboratories, which are not accredited will be inspected on a bi-annual basis.