Transcript CLIA-Waiver
CLIA-Waiver • What is CLIA? – The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). – The objective of the CLIA program is to ensure quality laboratory testing. – Any person or facility that performs laboratory tests on human specimens for the purpose of diagnosis and/or treatment is required by federal law to have a CLIA certificate. • For pharmacy purposes, a Certificate of Waiver is required. CLIA-Waiver • What is a CLIA-Waived test? – Tests approved by the FDA for home use that require very little training to perform (eg Glucometer devices). The only requirements for this type of testing are that the manufacturer's instructions are followed exactly and that there is documentation that the testing personnel have been trained to perform the test. – A list of approved CLIA-Waived tests can be found at: http://www.cms.hhs.gov/CLIA/downloads/waivetbl.pdf – In order to perform CLIA-Waived tests, an individual or entity is required to have a CLIA Certificate of Waiver (CLIA-Waiver). Steps to obtain CLIA-Waiver • Contact the State Department of Health – In New Mexico: http://dhi.health.state.nm.us/clia/how2apply.php Steps to obtain CLIA-Waiver • Complete CMS Application Form 116 – http://www.cms.hhs.gov/cmsforms/downloads/cms116.pdf Steps to obtain CLIA-Waiver • Complete CMS Application Form 116 Check this box and complete only the specified sections of application Steps to obtain CLIA-Waiver • Complete CMS Application Form 116 Check this box and complete only the specified sections of application Steps to obtain CLIA-Waiver • Complete CMS Application Form 116 Consider checking mobile laboratory if you plan on performing screenings outside the Pharmacy Steps to obtain CLIA-Waiver • Generally within 3 weeks you will be notified of the status of your application • Once the completed Form CMS-116 has been returned to the applicable State agency and it is processed, a fee remittance coupon will be issued. – The fee remittance coupon will indicate your CLIA ID number and the amount due for the certificate, and if applicable the compliance (survey) or validation fee. – The fee for a CLIA-Waiver is $150.00 paid biennially Steps to obtain CLIA-Waiver • Your pharmacy should develop a policy and procedures manual for CLIA-Waived testing. – The P&P 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). – For more information on proper procedures see the CDC document “Good Laboratory Practices for Waived Testing Sites” available at: http://www.cdc.gov/mmwr/PDF/rr/rr5413.pdf More Information • In New Mexico contact: Health Facility Licensing and Certification 5301 Central Ave NE Suite 400 Albuquerque, NM 87108 Phone: (505) 222-8646 • Requests for applications must be in writing and must be sent to the above address.