{"ref":"OH-HSP-LAB-01","title":"Laboratory Services and Waived Testing","category":"Clinical tasks","summary":"Sets how the Agency handles laboratory testing: when staff only assist a patient to self-test with an FDA-approved device (not laboratory testing), when the Agency itself performs waived tests and must hold a CLIA certificate of waiver and follow the manufacturer's instructions, how specimens are collected and sent only to CLIA-certified reference laboratories, and how results are documented and acted on. Ohio's hospice rules contain no separate laboratory requirement.","inShort":["Helping a patient use his or her own glucose meter is not laboratory testing.","Run a test on Agency equipment only if the Agency holds a CLIA certificate and the test is on the approved list.","Follow the manufacturer's instructions every time, and use a new single-use lancet for each fingerstick.","Clean and disinfect any shared meter after every use.","Record every result and report results outside the ordered range to the prescriber promptly."],"primaryCitation":"42 CFR §418.116(b)","citations":["OAC 3701-19-09(A)","OAC 3701-19-23(C)(6)"],"federalCitations":["42 CFR §418.116(b)","42 CFR §493.2","42 CFR §493.15","42 CFR §493.35","42 CFR §493.37","42 CFR §493.39","29 CFR §1910.1030"],"surveyorAsks":["Do your staff perform any laboratory tests, such as fingerstick blood glucose, on your own equipment? Show me your CLIA certificate.","Which tests are your staff allowed to perform, and how do you check their competency?"],"forms":[],"headings":["Terms of Reference","1. Purpose","2. Scope","3. Definitions","4. Policy Statement (42 CFR §418.116(b))","5. Deciding Whether a Test Is Needed","6. Assisting Patients With Self-Testing","7. Waived Testing by Agency Staff","8. Staff Competency and Safe Practice","9. Specimen Collection and Reference Laboratories","10. Results","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":"oh-hospice","state":"Ohio","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}}