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Laboratory Services and Waived Testing

Sets out when the Agency may perform laboratory tests (only under the right CLIA certificate, such as a Certificate of Waiver for waived tests), how nurses help patients use their own FDA-cleared self-test devices without substituting Agency equipment, how specimens are collected, labeled and sent only to CLIA-certified laboratories, and how results reach the ordering practitioner.

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About this policy
Policy number
MO-HH-CS-04
Version
1.0
Main rule
42 CFR §484.100(c) (adopted by 19 CSR 30-26.010(1)(A))
Library
Missouri home health · 57 policies
Category
Clinical tasks
Sections
17

In short

  • We do lab tests on Agency equipment only if we hold the right CLIA certificate and there is an order.
  • When you help a patient with a self-test, such as a blood sugar check, use the patient's own meter, never ours.
  • Label every specimen in front of the patient with two identifiers, the date, the time and your initials.
  • Send specimens only to certified laboratories, in leakproof, labeled containers.
  • Call the doctor right away about any critical result and write down who you spoke to.

What's inside

17 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) (adopted by 19 CSR 30-26.010(1)(A)))
  • 5. CLIA Certificate and Approved Tests
  • 6. Helping Patients With Self-Tests
  • 7. Specimen Collection, Labeling, and Transport
  • 8. Referral Laboratories
  • 9. 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 perform any tests, such as blood glucose or INR checks, on Agency equipment? Show me your CLIA certificate.
  • When a nurse helps a patient check blood sugar, whose meter is used?

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