Laboratory Services and Waived Testing
Makes sure no Agency staff member tests a patient’s specimen unless the Agency holds a current CLIA certificate covering the test and has settled with the Pennsylvania Department of Health whether a state clinical laboratory permit is also needed. Covers waived tests, helping patients test themselves, collecting specimens for certified referral laboratories, and recording and reporting results.
About this policy
- Policy number
- PA-HH-CS-04
- Version
- 1.0
- Main rule
- 42 CFR Part 493
- Library
- Pennsylvania home health · 56 policies
- Category
- Service delivery
- Sections
- 17
In short
- Do not test a patient’s blood or urine unless the Agency holds a current CLIA certificate and you are trained on the device.
- If the patient tests himself or herself with his or her own meter, you may watch and write down the result.
- Never use an Agency meter in place of the patient’s own device when helping the patient test.
- Follow the maker’s instructions every time, and clean shared meters after each use.
- Report results 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 Part 493; 28 Pa. Code §5.11)
- 5. CLIA Certificate and Pennsylvania Permit
- 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 nurses check blood glucose with their own meters? Show me your CLIA certificate.
- Does the Agency hold, or need, a Pennsylvania clinical laboratory permit?
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.