{"ref":"PA-HH-CS-04","title":"Laboratory Services and Waived Testing","category":"Service delivery","summary":"Makes sure no Agency staff member tests a patient’s specimen unless the Agency holds a current CLIA certificate covering the test and has settled with the Pennsylvania Department of Health whether a state clinical laboratory permit is also needed. Covers waived tests, helping patients test themselves, collecting specimens for certified referral laboratories, and recording and reporting results.","inShort":["Do not test a patient’s blood or urine unless the Agency holds a current CLIA certificate and you are trained on the device.","If the patient tests himself or herself with his or her own meter, you may watch and write down the result.","Never use an Agency meter in place of the patient’s own device when helping the patient test.","Follow the maker’s instructions every time, and clean shared meters after each use.","Report results outside the ordered range to the physician the same day."],"primaryCitation":"42 CFR Part 493","citations":["28 Pa. Code §601.3(b)","28 Pa. Code §601.31(d)","28 Pa. Code §5.1","28 Pa. Code §5.11(a)","49 Pa. Code §21.411(1)","49 Pa. Code §21.414(a)","35 P.S. §§2151-2165"],"federalCitations":["42 CFR Part 493","42 CFR §484.100(c)","42 CFR §493.15","42 CFR §493.37","42 CFR §493.39","29 CFR §1910.1030(d)(2)(xiii)"],"surveyorAsks":["Do your nurses check blood glucose with their own meters? Show me your CLIA certificate.","Does the Agency hold, or need, a Pennsylvania clinical laboratory permit?"],"forms":[],"headings":["Terms of Reference","1. Purpose","2. Scope","3. Definitions","4. Policy Statement (42 CFR Part 493; 28 Pa. Code §5.11)","5. CLIA Certificate and Pennsylvania Permit","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":"pa-hha","state":"Pennsylvania","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}}