{"ref":"MO-HSP-LAB-01","title":"Laboratory Services and Waived Testing","category":"Clinical tasks","summary":"Sets out when the Agency needs a Clinical Laboratory Improvement Amendments (CLIA) certificate, how it holds and renews a certificate of waiver for simple tests such as fingerstick blood glucose, how staff perform waived tests by following the manufacturer's instructions, how specimens are sent only to CLIA-certified reference laboratories, and how patients are helped to test themselves. The Missouri hospice rule has no laboratory section; the federal CLIA rules apply to any laboratory testing the Agency's staff perform.","inShort":["Do a fingerstick glucose or other test with an Agency device only if it is on the approved test list and you have passed the competency check.","Follow the manufacturer's instructions exactly, including quality control checks.","Never share lancets or fingerstick devices. Clean and disinfect shared meters after every use.","Helping a patient use their own home meter is fine. Record the result they get.","Send specimens only to the laboratories the Agency has approved."],"primaryCitation":"42 CFR §418.116(b)","citations":["19 CSR 30-35.010(1)(E)2.D","19 CSR 30-35.010(2)(C)1.B(IV)","19 CSR 30-35.010(1)(I)3"],"federalCitations":["42 CFR §418.116(b)","42 CFR Part 493","42 CFR §493.2","42 CFR §493.15","42 CFR §493.35","42 CFR §493.37","42 CFR §493.39"],"surveyorAsks":["Do your nurses do fingerstick blood glucose or other tests on patients? Show me your CLIA certificate and its expiration date.","Which tests are your staff allowed to perform, and how do you know each one is a waived test?"],"forms":[],"headings":["Terms of Reference","1. Purpose","2. Scope","3. Definitions","4. Policy Statement (42 CFR §418.116(b))","5. When a CLIA Certificate Is Needed","6. Holding the Certificate of Waiver","7. Performing Waived Tests","8. Testing Procedure for Staff","9. Specimens Sent to Reference Laboratories","10. Helping Patients Test Themselves","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":"mo-hospice","state":"Missouri","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}}