{"ref":"NC-HH-CS-05","title":"Laboratory Services and Waived Testing","category":"Clinical tasks","summary":"Allows Agency staff to perform laboratory tests only under a current CLIA certificate (normally a certificate of waiver, limited to waived tests done exactly as the manufacturer directs), never to substitute Agency equipment for a patient’s own self-testing device, and to send specimens only to certified laboratories. Sets ordering, collection, transport, result reporting and certificate renewal.","inShort":["Staff may perform a lab test only if the Agency has a current CLIA certificate that covers it.","Follow the manufacturer’s instructions for every test, and never use an expired strip or reagent.","When a patient tests with his or her own meter, never swap in an Agency meter.","Label specimens in front of the patient with two identifiers and use leak-proof containers.","Report any result outside the ordered range to the physician the same day."],"primaryCitation":"42 CFR §484.100(c)","citations":["10A NCAC 13J .1109(b)","10A NCAC 13J .1302","10A NCAC 13J .1402(b)"],"federalCitations":["42 CFR §484.100(c)","42 CFR Part 493","42 CFR §493.15","42 CFR §493.35","42 CFR §493.37","42 CFR §493.39","42 CFR §484.60(b)","29 CFR §1910.1030"],"surveyorAsks":["Show me your CLIA certificate. Which tests do your nurses perform?","When does the certificate expire, and when will you apply to renew it?"],"forms":[],"headings":["Terms of Reference","1. Purpose","2. Scope","3. Definitions","4. Policy Statement (42 CFR §484.100(c) and 42 CFR Part 493)","5. CLIA Certificate","6. Helping a Patient Test Himself or Herself","7. Performing Waived Tests","8. Collecting Specimens for a Referral Laboratory","9. Recording and Reporting 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":"nc-hha","state":"North Carolina","service":"Home health","guides":[{"path":"/guides/home-health-agency-policies/","h1":"What policies and procedures are required for home health agencies?"},{"path":"/guides/home-health-conditions-of-participation/","h1":"Home health Conditions of Participation: which policies each one needs"}],"agency":{"name":"Sample Agency","legalName":"Sample Agency, LLC","logo":null}}