{"ref":"TX-HH-CS-04","title":"Laboratory Services and Waived Testing","category":"Service delivery","summary":"Requires the Agency to hold a CLIA certificate of waiver before any staff member performs a laboratory test, limits testing to waived tests done exactly as the manufacturer directs, sets out how staff help patients test themselves with their own devices, and covers specimen collection, referral laboratories, and reporting results to the practitioner.","inShort":["Do not do any lab test, such as a finger-stick glucose, unless the Agency holds a current CLIA certificate and you have been trained on that device.","Follow the manufacturer’s instructions exactly. Do not use expired or badly stored strips.","If the patient tests with his or her own meter, the patient does the test. Write the result down as patient-performed.","Use a new lancet every time, put it straight into a sharps container, and clean shared meters after every patient.","Report any result outside the ordered range to the practitioner and your supervisor the same day."],"primaryCitation":"26 TAC §558.284","citations":["26 TAC §558.284","26 TAC §558.281","26 TAC §558.301","22 TAC §224.8","22 TAC §225.10"],"federalCitations":["42 U.S.C. §263a","42 CFR §484.100(c)","42 CFR Part 493","42 CFR §493.15","42 CFR §493.37","42 CFR §493.39","29 CFR §1910.1030"],"surveyorAsks":["Do your nurses check blood glucose or PT/INR on patients? Show me your CLIA certificate and when it expires.","Which tests are on your certificate, and where are the manufacturer’s instructions for each device?"],"forms":[],"headings":["Terms of Reference","1. Purpose","2. Scope","3. Definitions","4. Policy Statement (26 TAC §558.284)","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":"tx-lhhs","state":"Texas","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 Home Health Agency","legalName":"Sample Home Health Agency, LLC","logo":null}}