{"ref":"OH-HH-CS-04","title":"Laboratory Services and Waived Testing","category":"Service delivery","summary":"Explains when the Agency is doing laboratory testing that needs a CLIA certificate and when it is only helping a patient test with the patient’s own FDA-cleared device; limits Agency testing to waived tests under a current CLIA certificate of waiver, performed by trained staff following the manufacturer’s instructions; and sets the steps for collecting and sending specimens to certified referral laboratories and reporting results.","inShort":["When a patient tests with his or her own meter, coach and record the result. Never swap in the Agency’s equipment.","Agency staff perform only waived tests, under the Agency’s CLIA certificate of waiver, following the manufacturer’s instructions.","Collect specimens only on an order, label them in the patient’s presence, and use leakproof containers.","Report a critical result to the practitioner at once and write down who you told."],"primaryCitation":"42 CFR §484.100(c)","citations":[],"federalCitations":["42 CFR §484.100(c)","42 CFR Part 493","42 CFR §493.15","42 CFR §493.35","42 CFR §493.39","29 CFR §1910.1030","42 CFR §484.60(b)(1)","42 CFR §484.110(a)"],"surveyorAsks":["Do your staff perform any laboratory tests? Show me your CLIA certificate.","Which tests do your nurses perform, and are they all on the waived list?"],"forms":[],"headings":["Terms of Reference","1. Purpose","2. Scope","3. Definitions","4. Policy Statement (42 CFR §484.100(c))","5. Two Kinds of Testing","6. CLIA Certificate of Waiver","7. Performing Waived Tests","8. Helping a Patient Self-Test","9. Collecting Specimens for a Referral Laboratory","10. Recording and Reporting 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-hha","state":"Ohio","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}}