{"ref":"DC-HSP-LAB-01","title":"Laboratory Services and Waived Testing","category":"Clinical tasks","summary":"Sets out when Agency staff may perform laboratory tests: only waived tests under a CLIA certificate of waiver (42 CFR Part 493), only after the Administrator has confirmed with DC Health whether a District clinical laboratory license is also needed (D.C. Code §44-202), and with specimens referred only to laboratories CLIA-certified for the tests; and how results are acted on.","inShort":["You may help a patient use their own home test device, such as a glucose meter.","Agency staff perform only approved waived tests, and only under the Agency’s CLIA certificate.","Follow the manufacturer’s instructions and do the quality checks for the device.","Send specimens only to the laboratories the Agency has approved.","Report results outside the ordered range to the physician at once and document what was done."],"primaryCitation":"42 CFR §418.116(b)","citations":["D.C. Code §44-201","D.C. Code §44-202","D.C. Code §44-204"],"federalCitations":["42 CFR §418.116(b)","42 CFR Part 493","42 CFR §493.15","42 CFR §493.35"],"surveyorAsks":["Do your nurses perform any tests, such as fingerstick blood glucose? Show me your CLIA certificate.","Which reference laboratories do you send specimens to, and how did you confirm they are CLIA-certified?"],"forms":[],"headings":["Terms of Reference","1. Purpose","2. Scope","3. Definitions","4. Policy Statement (42 CFR §418.116(b))","5. Which Tests Staff May Perform","6. CLIA Certificate of Waiver","7. District Clinical Laboratory License","8. Specimens Sent to Reference Laboratories","9. Acting on Results","10. Responsibilities","11. Records and Compliance Monitoring","12. Staff Training","13. References","14. Related Policies and Forms","15. Approval","16. Revision History"],"version":"1.0","sample":false,"pack":"dc-hospice","state":"Washington, DC","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}}