Laboratory Services and Waived Testing
Sets out when Agency staff may perform laboratory tests: only waived tests under a CLIA certificate of waiver (42 CFR Part 493), only after the Administrator has confirmed with DC Health whether a District clinical laboratory license is also needed (D.C. Code §44-202), and with specimens referred only to laboratories CLIA-certified for the tests; and how results are acted on.
About this policy
- Policy number
- DC-HSP-LAB-01
- Version
- 1.0
- Main rule
- 42 CFR §418.116(b)
- Library
- Washington, DC hospice · 60 policies
- Category
- Clinical tasks
- Sections
- 17
In short
- You may help a patient use their own home test device, such as a glucose meter.
- Agency staff perform only approved waived tests, and only under the Agency’s CLIA certificate.
- Follow the manufacturer’s instructions and do the quality checks for the device.
- Send specimens only to the laboratories the Agency has approved.
- Report results outside the ordered range to the physician at once and document what was done.
What's inside
17 sections. The full text comes with the One-time Policy Pack.
- Terms of Reference
- 1. Purpose
- 2. Scope
- 3. Definitions
- 4. Policy Statement (42 CFR §418.116(b))
- 5. Which Tests Staff May Perform
- 6. CLIA Certificate of Waiver
- 7. District Clinical Laboratory License
- 8. Specimens Sent to Reference Laboratories
- 9. Acting on 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 perform any tests, such as fingerstick blood glucose? Show me your CLIA certificate.
- Which reference laboratories do you send specimens to, and how did you confirm they are CLIA-certified?
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