US · guidance
CMS SOM App. C, Tag D6103
§493.1445 Standard: Laboratory director responsibilities
(e)(13) Ensure that policies and procedures are established for monitoring
individuals who conduct preanalytical, analytical, and postanalytical phases of
testing to assure that they are competent and maintain their competency to process
specimens, perform test procedures and report test results promptly and
proficiently, and whenever necessary, identify needs for remedial training or
continuing education to improve skills;
Interpretive Guidelines §493.1445(e)(13)
Personnel performing only preanalytic (e.g., entering requisitions into a computer
system) and postanalytic activities (e.g., sending final reports) are not required to be
listed on Form 209. Surveyors do not normally check for documented competency
evaluation on these individuals. However, if you discover problems in the preanalytic
and postanalytic activities related to testing personnel not listed on the Form CMS-209,
cite D6030 or D6103 (laboratory director).
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
9bb5ddb76665f62c3a867f8ed85b55985169bd28eeb5ef68da5456fea791dba8
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