Laboratory Services and Waived Testing
Allows Agency staff to perform laboratory tests only under a current CLIA certificate (normally a certificate of waiver, limited to waived tests done exactly as the manufacturer directs), never to substitute Agency equipment for a patient’s own self-testing device, and to send specimens only to certified laboratories. Sets ordering, collection, transport, result reporting and certificate renewal.
About this policy
- Policy number
- NC-HH-CS-05
- Version
- 1.0
- Main rule
- 42 CFR §484.100(c)
- Library
- North Carolina home health · 57 policies
- Category
- Clinical tasks
- Sections
- 17
In short
- Staff may perform a lab test only if the Agency has a current CLIA certificate that covers it.
- Follow the manufacturer’s instructions for every test, and never use an expired strip or reagent.
- When a patient tests with his or her own meter, never swap in an Agency meter.
- Label specimens in front of the patient with two identifiers and use leak-proof containers.
- Report any result outside the ordered range to the physician the same day.
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 §484.100(c) and 42 CFR Part 493)
- 5. CLIA Certificate
- 6. Helping a Patient Test Himself or Herself
- 7. Performing Waived Tests
- 8. Collecting Specimens for a Referral Laboratory
- 9. Recording and Reporting 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
- Show me your CLIA certificate. Which tests do your nurses perform?
- When does the certificate expire, and when will you apply to renew it?
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