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Laboratory Services, Specimen Collection, and Waived Testing

Sets out when Agency staff may perform laboratory tests in the home and what they need first: a CLIA certificate (42 CFR Part 493) and a California clinical laboratory registration for waived tests, or a license for moderate or high complexity tests (Cal. Bus. & Prof. Code §1265); a practitioner order; competent staff; and results reported to the practitioner and filed in the record (22 CCR §74735(a)(6)). Assisting a patient with the patient’s own FDA-cleared self-test device is not Agency testing. Specimens go only to laboratories certified under CLIA and licensed or registered in California.

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About this policy
Policy number
CA-HH-CS-04
Version
1.0
Main rule
42 CFR §484.100(c)
Library
California home health · 58 policies
Category
Clinical tasks
Sections
18

In short

  • Only test with an Agency device if you were trained on it. The Agency must hold a CLIA certificate and a California registration first.
  • Helping patients use their own glucose meter is fine. Do not swap in an Agency meter.
  • Every specimen needs an order. Label it in front of the patient with name, date of birth, date and time, and your initials.
  • Aides do not draw blood.
  • Call the practitioner right away about critical results, and make sure every report goes in the record.

What's inside

18 sections. The full text comes with the One-time Policy Pack.

Full text with a package
  • Terms of Reference
  • 1. Purpose
  • 2. Scope
  • 3. Definitions
  • 4. Policy Statement (42 CFR §484.100(c))
  • 5. Testing With Agency Equipment
  • 6. Assisting With the Patient’s Own Test
  • 7. Who May Collect Specimens
  • 8. Collecting, Labeling, and Sending Specimens
  • 9. Choosing Referral Laboratories
  • 10. 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 with Agency equipment? Show me your CLIA certificate and your California registration.
  • Which laboratories do you send specimens to, and how do you know they are certified?

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