Proper (CLIA) Waived Lab Testing & Protocols
CLIA– Clinical Laboratory Improvement Amendments is to ensure timeliness, accurate, and reliability in patient testing. This act falls under strict, high quality standards, wherever the tests were performed. This agreement was passed in 1988, but the regulations weren’t passed and published until late 1992 of the Federal Register. The complexity and make-up of the tests mainly the requirements and not where the tests were performed. Let’s take a closer look at some of the terms.
So What Is A Waived Test?
- Waived Tests are classified as simple laboratory procedures and exams, which has a slight risk of error related results. By determining these tests, The Food And Drug Administration has a strict criteria of the application process and how it’s run. These tests are to be very simple and to minimize risk of error.
What’s A Laboratory?
- Laboratories are testing facilities that involves the proper testing of human body material or substances. The purpose is to provide diagnostic information, treatment, impairment, and assessment of health for people. Information on labs and tests, go to https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/. for more information and knowledge.
If you are a person in the medical field, doctor/nurse and you have multiple locations and want to perform Waived Testing, you’ll need a (CLIA) Certificate for each location you perform testing. The only way around this matter is if you qualify for an exemption. If there is no fixed or physical location and you move from site to site such as Health Screening Fairs, Mobile Units, or places of Temporary Residence, may be covered the Certificate of Primary Site. Also any local, federal, or state labs owned by the government, with limited health testing, can file single applications as needed.
You can’t perform any waived testing until after you have applied for and received a fee coupon. Just follow the directions on the coupon for this payment. Your certificate will be mailed to you after the CMS receives your payment in full. Some states agencies have slightly different requirements, so check with your state agency.
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