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Starting
a new lab that is NONWAIVED? (MODERATE or HIGH complexity)?
- State
forms:
LAB
144 — Application for Clinical Laboratory License
LAB
144A — Laboratory Testing Declaration, including names(s)
of manufacturer(s) and/or equipment(s) and estimated annual
volumes
LAB
144B — Application for Additional Clinical Laboratory
Testing Sites, ONLY if qualified for multiple site exception
under California Business and Professions Code 1265 (d)
LAB
1513 — Disclosure of Ownership and Control Interest
Statement, including home addresses of all owners and officers.
LAB
116 — Laboratory Personnel Report
LAB
183 — Director’s Attestation (each director or co-director
must file a separate attestation).
- Federal
forms:
CMS
116 — CLIA application, unless already certified by
CMS
CMS
209 — CLIA Laboratory Personnel Report
Remember:
Include documentation of the director’s qualifications:
For moderate complexity testing, a physician licensed after
Feb. 28, 1992, documentation of at least one year training
or experience directing or supervising non-waived laboratory
testing OR certificate of completion of 20 continuing medical
education units in laboratory practice.
For high complexity testing, documentation of at least one
year of laboratory training during medical residency or two
years experience directing or supervising high complexity
testing.
For Dermatopathology, Histopathology other than Dermatopathology,
and Anatomic/Clinical Pathology, submit a copy of the respective
board certification.
All documents must have original signature(s)
Provide a copy of the Articles of Incorporation
Starting
a new lab that is WAIVED or PPMP?
- State
forms:
LAB
155 — Application for Clinical Laboratory Registration
LAB
116 — Laboratory Personnel Report (for PPMP only)
- Federal
forms:
CMS
116 — CLIA application, unless already certified by
CMS
Remember:
All documents must have original signature(s)
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