Laboratory Services and Waived Testing
Explains when the Agency is doing laboratory testing that needs a CLIA certificate and when it is only helping a patient test with the patient’s own FDA-cleared device; limits Agency testing to waived tests under a current CLIA certificate of waiver, performed by trained staff following the manufacturer’s instructions; and sets the steps for collecting and sending specimens to certified referral laboratories and reporting results.
About this policy
- Policy number
- OH-HH-CS-04
- Version
- 1.0
- Main rule
- 42 CFR §484.100(c)
- Library
- Ohio home health · 59 policies
- Category
- Service delivery
- Sections
- 18
In short
- When a patient tests with his or her own meter, coach and record the result. Never swap in the Agency’s equipment.
- Agency staff perform only waived tests, under the Agency’s CLIA certificate of waiver, following the manufacturer’s instructions.
- Collect specimens only on an order, label them in the patient’s presence, and use leakproof containers.
- Report a critical result to the practitioner at once and write down who you told.
What's inside
18 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))
- 5. Two Kinds of Testing
- 6. CLIA Certificate of Waiver
- 7. Performing Waived Tests
- 8. Helping a Patient Self-Test
- 9. Collecting Specimens for a Referral Laboratory
- 10. Recording and Reporting 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? Show me your CLIA certificate.
- Which tests do your nurses perform, and are they all on the waived list?
See Cura Core with your agency's name on it.
Choose your state and type of agency, buy your Policy Pack online and get your sign-in by email. Already a customer? Sign in to your portal.