Laboratory Services and Waived Testing
Sets out how the Agency provides laboratory services when medically necessary, directly or through contract, in compliance with CLIA: when the Agency needs a CLIA certificate of waiver (for example for fingerstick blood glucose tests by staff), the waived tests staff may perform and how, renewal and change notices, the exception for helping a patient use an FDA-approved self-test device, use of certified reference laboratories, specimen handling, results, and cleaning of shared devices.
About this policy
- Policy number
- MI-HSP-LAB-01
- Version
- 1.0
- Main rule
- Mich. Admin. Code R 325.45211
- Library
- Michigan hospice · 59 policies
- Category
- Clinical tasks
- Sections
- 18
In short
- Do a test only if a practitioner ordered it and it is on our approved list of waived tests.
- Follow the manufacturer's instructions every time, including quality control checks.
- Record the result and call the practitioner at once if it is outside the range set.
- Never share a lancet device. Clean and disinfect a shared glucose meter after every patient.
- Helping a patient use their own home test is fine. Ask the office before doing any other test.
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 (Mich. Admin. Code R 325.45211; 42 CFR §418.116(b))
- 5. When Staff May Test
- 6. Certificate of Waiver
- 7. Performing a Waived Test
- 8. Shared Devices and Infection Prevention
- 9. Specimens for Reference Laboratories
- 10. Training and Competency
- 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 nurses do fingerstick glucose checks or other tests? Show me your CLIA certificate and its expiration date.
- Which tests are your staff allowed to perform, and where are the manufacturer's instructions?
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