{"ref":"MI-HSP-LAB-01","title":"Laboratory Services and Waived Testing","category":"Clinical tasks","summary":"Sets out how the Agency provides laboratory services when medically necessary, directly or through contract, in compliance with CLIA: when the Agency needs a CLIA certificate of waiver (for example for fingerstick blood glucose tests by staff), the waived tests staff may perform and how, renewal and change notices, the exception for helping a patient use an FDA-approved self-test device, use of certified reference laboratories, specimen handling, results, and cleaning of shared devices.","inShort":["Do a test only if a practitioner ordered it and it is on our approved list of waived tests.","Follow the manufacturer's instructions every time, including quality control checks.","Record the result and call the practitioner at once if it is outside the range set.","Never share a lancet device. Clean and disinfect a shared glucose meter after every patient.","Helping a patient use their own home test is fine. Ask the office before doing any other test."],"primaryCitation":"Mich. Admin. Code R 325.45211","citations":["Mich. Admin. Code R 325.45211","Mich. Admin. Code R 325.45215(9)","Mich. Admin. Code R 325.45199","Mich. Admin. Code R 325.45191"],"federalCitations":["42 CFR §418.116(b)","42 CFR §493.15","42 CFR §493.35","42 CFR §493.37","42 CFR §493.39","42 CFR §418.60"],"surveyorAsks":["Do your nurses do fingerstick glucose checks or other tests? Show me your CLIA certificate and its expiration date.","Which tests are your staff allowed to perform, and where are the manufacturer's instructions?"],"forms":[],"headings":["Terms of Reference","1. Purpose","2. Scope","3. Definitions","4. Policy Statement (Mich. Admin. Code R 325.45211; 42 CFR §418.116(b))","5. When Staff May Test","6. Certificate of Waiver","7. Performing a Waived Test","8. Shared Devices and Infection Prevention","9. Specimens for Reference Laboratories","10. Training and Competency","11. Responsibilities","12. Records and Compliance Monitoring","13. Staff Training","14. References","15. Related Policies and Forms","16. Approval","17. Revision History"],"version":"1.0","sample":false,"pack":"mi-hospice","state":"Michigan","service":"Hospice","guides":[{"path":"/guides/hospice-policies/","h1":"What policies are required for hospice?"},{"path":"/guides/hospice-conditions-of-participation/","h1":"Hospice Conditions of Participation: which policies each one needs"}],"agency":{"name":"Sample Agency","legalName":"Sample Agency, LLC","logo":null}}