Laboratory Services and Waived Testing
Sets out when the Agency may perform laboratory tests, the federal CLIA certificate of waiver it needs if staff perform any waived test, the Pennsylvania clinical laboratory permit question the Administrator must settle with the Department of Health before testing starts, how waived tests are performed and recorded, how specimens go to certified reference laboratories, and how staff help patients with their own home test devices.
About this policy
- Policy number
- PA-HSP-LAB-01
- Version
- 1.0
- Main rule
- 42 CFR §418.116(b)
- Library
- Pennsylvania hospice · 60 policies
- Category
- Clinical tasks
- Sections
- 19
In short
- Only perform a test if there is an order and the result will guide comfort care.
- Use only Agency devices on the approved test list, and only after you have been trained and checked on that device.
- Follow the manufacturer's instructions exactly and do the quality control checks on the device log.
- Record the result the same day and report any result outside the ordered range at once.
- You may help patients use their own home test devices, but never use a patient's device on anyone else.
What's inside
19 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 §418.116(b))
- 5. Three Kinds of Testing Activity
- 6. CLIA Certificate of Waiver
- 7. Pennsylvania Clinical Laboratory Permit
- 8. Approved Test List
- 9. Performing a Waived Test
- 10. Specimens for a Reference Laboratory
- 11. Helping Patients With Their Own Tests
- 12. Responsibilities
- 13. Records and Compliance Monitoring
- 14. Staff Training and Competency
- 15. References
- 16. Related Policies and Forms
- 17. Approval
- 18. Revision History
An inspector may ask
- Do your nurses perform any tests themselves, such as fingerstick glucose? Show me your CLIA certificate.
- Has the Department of Health told you whether you need a Pennsylvania clinical laboratory permit?
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