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Laboratory Services and CLIA

Sets out when the Agency’s laboratory testing falls under the Clinical Laboratory Improvement Amendments (CLIA) rules in 42 CFR Part 493: testing with Agency equipment needs a CLIA certificate (a certificate of waiver for waived tests only), helping a patient use their own FDA-cleared home-use device does not, the Agency never substitutes its equipment for the patient’s, and specimens are sent only to laboratories certified for the tests ordered. Covers specimen collection, handling and result follow-up, and reporting CLIA changes.

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About this policy
Policy number
MI-HH-CS-04
Version
1.0
Main rule
42 CFR §484.100(c)
Library
Michigan home health · 57 policies
Category
Service delivery
Sections
17

In short

  • Helping a patient test with their own meter is not lab testing. Coach them and record the result.
  • Never use an Agency meter in place of the patient’s, unless the Agency holds a CLIA certificate that covers it.
  • Do only waived tests the Agency’s certificate covers, and follow the maker’s instructions every time.
  • Send specimens only to a CLIA-certified lab, labeled with two patient identifiers.
  • Report abnormal results to the physician the same day.

What's inside

17 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 §484.100(c))
  • 5. Deciding Whether CLIA Applies
  • 6. The Agency’s CLIA Certificate
  • 7. Performing Waived Tests
  • 8. Specimen Collection and Referral
  • 9. Results
  • 10. Responsibilities
  • 11. Records and Compliance Monitoring
  • 12. Staff Training
  • 13. References
  • 14. Related Policies and Forms
  • 15. Approval
  • 16. Revision History

An inspector may ask

  • Do your nurses run any tests with Agency-owned devices? Show me your CLIA certificate.
  • Which tests do you perform, and are they all on the waived list for your certificate?

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