Laboratory Services and Waived Testing
Makes sure no Agency staff member performs a laboratory test on a patient’s specimen without a current CLIA certificate covering it, limits Agency testing to waived tests done exactly as the manufacturer directs, keeps help with a patient’s own self-testing separate from Agency testing, and sends specimens only to certified laboratories.
About this policy
- Policy number
- GA-HH-CS-04
- Version
- 1.0
- Main rule
- 42 CFR §484.100(c)
- Library
- Georgia home health · 56 policies
- Category
- Service delivery
- Sections
- 17
In short
- Do not perform any test on a patient’s blood or urine unless the Agency has a CLIA certificate and the test is approved.
- If the patient tests with their own meter, let the patient do it and record the result as patient-performed.
- Never use an Agency meter in place of the patient’s own meter.
- Report results outside the ordered range to the physician the same day.
- Aides do not perform laboratory tests.
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
- Do your staff perform any tests, such as finger-stick glucose or urine dipsticks? Show me your CLIA certificate.
- Which devices and tests are approved, and where are the manufacturer’s instructions?
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.