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.
Prior to 1988, roughly 25% of patient testing conducted in laboratories was not meeting minimum quality requirements. Studies showed that the laboratories that followed minimum quality standards performed better than the laboratories that did not.
The CLIA standards were created in order to ensure that a patient’s test results would be accurate, timely and reliable, regardless of where in the United States the test would be performed.
What is a CLIA waiver?
Every laboratory and home test kit 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.
CLIA certification has to be renewed every two years by testing in a controlled environment. Generally, this testing is conducted without monitoring unless a complaint has been made about the company.
Which tests are CLIA waived?
There are specific tests which have been CLIA waived. These are:
Urinalysis tests performed 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 by 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.
Process time for CLIA certification takes approximately two months once the form has been received. Once Form CMS-116 is submitted to the State Agency and is processed, you will be issued a fee remittance coupon. The fee remittance coupon will indicate your CLIA ID, the amount to be paid for the certificate, as well as any other fees. Certificate fees vary, depending on the number and type of tests performed in your laboratory.
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 accredited as per CLIA laws will be inspected as and when deemed necessary by the Secretary. Those that are not accredited will be inspected on a bi-annual basis.
Based on CLIA guidelines, tests and test systems that comply with the risk, error, and complexity requirements are granted a certificate of waiver. In November 2007, the U.S. Congress amended waiver provisions making it clear that FDA-approved tests for home use are automatically CLIA-waived.
This was done despite the fact that many of them were performed against designed protocols. Half were done incorrectly resulting in medical errors leading to fatal consequences.
Although the CLIA requires a waived test to be simple and have a low risk for erroneous results, it does not mean that they are completely free from error. Errors can happen during the testing process, especially when the instructions of the manufacturer were not completely followed. An error could also happen when the person conducting the test lacks familiarity with the testing system.
Who Needs CLIA Waived Tests?
The people who are most likely to need and use these tests are people who must monitor things that relate to their health and reproduction in their home.
Women seeking to conceive: Women who are trying to become pregnant might use an ovulation test and/or a pregnancy test to evaluate her ability to conceive or to verify if conception has occurred. These tests help her to better monitor the condition of her hormonal state and how that state affects her reproduction.
Those with blood sugar issues: People who must monitor their blood sugar levels might use these tests. This includes those with diabetes and those who suffer from low levels of blood sugar. Evaluating the level of glucose in these people’s systems can mean the difference between life and death. The level of glucose in a person’s body must be in the right balance with other factors in the body, if that level is too high or too low it can cause illness and even degradation of the body over time.
Those at risk for Cancer: These tests evaluate the level of blood present in the fecal matter dictating the presence of cancers like colorectal cancer in the body.
Those who deal with Arthritis: These tests test for the level of swelling in the body to evaluate the presence and severity of diseases such as arthritis.
Those whose blood must be evaluated: The level of hemoglobin in the blood must be evaluated to determine if anemia is present and causing health problems for the patient.
What is a Non-CLIA Waived Testing?
On the other hand, non-CLIA waived testing, as defined by the CDC, involve tests that have a moderate or high level of complexity. Non-CLIA waived testing should be conducted in CLIA-certified laboratories, which need to be inspected and should comply with the standards set by the CLIA.
The fact that they have already met the standards set forth by CLIA, one can already count on their reliability. As such, there is no longer a need for patients and practitioners to doubt the effectiveness of using them for laboratory testing.
These cups have already been approved, and so you no longer need to check if the laboratory where they are being tested is already CLIA-certified.
CLIA waived drug tests are deemed accurate and so there is zero or minimal room for error. Therefore, the chances that there will be an error is relatively significant. Patients will, therefore, have peace of mind and assurance that there will be no false-positive results for the procedure being conducted.
CLIA waived urine testing cups also offer a wide range of flexibility. Patients can opt for a 12-panel or 10-panel testing cup. There is also an option to choose a 5-panel cup. The choice will boil down to the type of drug being tested.