Form CMS-209 PDF Details

List below all personnel with responsibilities for testing in the last two years.

Not listed: do not list personnel that only perform specimen processing, clerical functions, waived or no testing.

Positions: for moderate complexity testing, list the positions of LD, CC, TC and TP. For high complexity testing, list the positions of LD, CC, TS, GS and TP.

Separate line: use a separate line for personnel holding more than one CLIA position.

Laboratory director: only one person may be listed as the laboratory director.

Qualification: indicate each individual's highest level of qualification: use (M) for moderate and (H) for high complexity.

QuestionAnswer
Form NameForm CMS-209
Form Length2 pages
Fillable?Yes
Fillable fields165
Avg. time to fill out28 min
Edition09/2025
Issuing agencyCenters for Medicare & Medicaid Services
Who signsThe laboratory director
Matches the agency's fileYes, checked October 1, 2026
Other namesCMS-209, CMS 209, CMS209, Form 209, Laboratory Personnel Report (CLIA)
Official sourceForm CMS-209 (Rev 09/2025), Centers for Medicare & Medicaid Services