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Laboratory Services and Waived Testing

Sets how the Agency handles laboratory testing: when staff only assist a patient to self-test with an FDA-approved device (not laboratory testing), when the Agency itself performs waived tests and must hold a CLIA certificate of waiver and follow the manufacturer's instructions, how specimens are collected and sent only to CLIA-certified reference laboratories, and how results are documented and acted on. Ohio's hospice rules contain no separate laboratory requirement.

Preview: full text with a package
About this policy
Policy number
OH-HSP-LAB-01
Version
1.0
Main rule
42 CFR §418.116(b)
Library
Ohio hospice · 60 policies
Category
Clinical tasks
Sections
18

In short

  • Helping a patient use his or her own glucose meter is not laboratory testing.
  • Run a test on Agency equipment only if the Agency holds a CLIA certificate and the test is on the approved list.
  • Follow the manufacturer's instructions every time, and use a new single-use lancet for each fingerstick.
  • Clean and disinfect any shared meter after every use.
  • Record every result and report results outside the ordered range to the prescriber promptly.

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. Deciding Whether a Test Is Needed
  • 6. Assisting Patients With Self-Testing
  • 7. Waived Testing by Agency Staff
  • 8. Staff Competency and Safe Practice
  • 9. Specimen Collection and Reference Laboratories
  • 10. Results
  • 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 staff perform any laboratory tests, such as fingerstick blood glucose, on your own equipment? Show me your CLIA certificate.
  • Which tests are your staff allowed to perform, and how do you check their competency?

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