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Laboratory Services and Waived Testing

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.

Preview: full text with a package
About this policy
Policy number
MO-HSP-LAB-01
Version
1.0
Main rule
42 CFR §418.116(b)
Library
Missouri hospice · 59 policies
Category
Clinical tasks
Sections
18

In short

  • 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.

What's inside

18 sections. The full text comes with the One-time Policy Pack.

Full text with a package
  • 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

An inspector may ask

  • 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?

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