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CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA) Linked below are documents from the CDC that discusses best practices for CLIA waived testing that is very helpful and describes proper policies and procedures for anyone wanting to provide testing. It is highly recommend that any pharmacy that provides CLIA waived testing develop a policy and procedures manual so that proper testing can be performed for each patient. The policy and procedures manual needs to include procedures for each test and should include documentation of quality control (testing of new lots of test cassettes or reagents, testing the device, documenting proper storage, etc). Q & A: How difficult is it to get a CLIA Waiver? It is not hard at all. Those interested should contact the New Mexico Department of Health for specific information. A power point slide show is linked below that I think will help folks to understand better. Do you have to register the pharmacy as a lab? You can register as a pharmacy or as a lab or several other categories (see slide show). A Pharmacy should register as a mobile laboratory if you plan to do screenings at a variety of locations. What does a CLIA waiver allow you to do? It allows you to offer laboratory testing to patients for tests that are CLIA-waived. Click the link for a list of CLIA-Waived tests. Joe R. Anderson, PharmD, PhC, BCPS |
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Information Links: Slide Show - How to obtain a waiver Morbidity and Mortality Weekly Report
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