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Laboratory Services and Waived Testing

Sets out when hospice staff may do laboratory tests: helping a patient use his or her own FDA-approved home test, performing waived tests such as fingerstick blood glucose under the Agency’s CLIA Certificate of Waiver, and collecting specimens for a CLIA-certified reference laboratory. Covers the certificate Georgia law requires, following manufacturer instructions, competency, quality checks, safe handling, transport and disposal of specimens, results and records.

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About this policy
Policy number
GA-HSP-LAB-01
Version
1.0
Main rule
42 CFR Part 493
Library
Georgia hospice · 60 policies
Category
Clinical tasks
Sections
17

In short

  • We do only simple waived tests, such as fingerstick glucose, under our CLIA Certificate of Waiver.
  • Test only with an order and only with devices on the approved test list.
  • Follow the manufacturer’s instructions exactly and record quality control checks.
  • Label specimens with two identifiers and carry them sealed in a biohazard bag and transport box.
  • Record results the same day and report any abnormal result at once.

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 Part 493; O.C.G.A. §31-22-2)
  • 5. Three Kinds of Testing Activity
  • 6. Certificate of Waiver and Approved Test List
  • 7. Performing a Waived Test
  • 8. Specimen Collection, Transport and Disposal
  • 9. Assisting Patients With Their Own Tests
  • 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 do any testing in the home? Show me your CLIA certificate and its expiry date.
  • Show me the manufacturer instructions and quality control log for the glucose meters your nurses use.

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