US · guidance
CMS SOM App. C, Tag D6107
§493.1445 Standard: Laboratory director responsibilities
(e)(15) Specify, in writing, the responsibilities and duties of each consultant and
each supervisor, as well as each person engaged in the performance of the
preanalytic, analytic, and postanalytic phases of testing, that identifies which
examinations and procedures each individual is authorized to perform, whether
supervision is required for specimen processing, test performance or result
reporting and whether supervisory or director review is required prior to reporting
patient test results.
Interpretive Guidelines §493.1445(e)(15)
The director must assign, in writing, the duties/responsibilities to each person involved in
all phases of the testing process. The list of assigned duties must be current.
History
Rev. 233; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
f0089182670bd6cc9822bc4b6954216e9e52a629ddc34c201a0de25ec5b0e1ab
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