Items 1 to 3: laboratory
Laboratory name, CLIA identification number, and street address with city, state and ZIP code.
CMS-209
LABORATORY PERSONNEL REPORT (CLIA)
- Agency
- CMS
- Revision
- 09/2025
- Fillable fields
- 165
- Pages
- 2
- Official source
- CMS form page
- Checked
- October 20, 2026
Form CMS-209: Laboratory Personnel Report (CLIA)
Form CMS-209 is the Laboratory Personnel Report (CLIA) from the Centers for Medicare & Medicaid Services, part of the U.S. Department of Health and Human Services. Its title says it is for moderate and high complexity testing. Page 2 says the form will be completed by the laboratory and used by the surveyor to review the qualifications of technical personnel in the laboratory.
The form asks for the laboratory's name, CLIA identification number and address, then a table of personnel with the CLIA positions each person holds and whether their highest qualification is moderate (M) or high (H) complexity. The laboratory director signs a certification that everyone listed qualifies for the position shown under 42 CFR part 493 subpart M.
The Paperwork Reduction Act notice estimates an average of 30 minutes per response. You can fill it out free in your browser on this page and download the result without an account.
What's on Form CMS-209
Item 4: instructions and positions
Who to list, and the position codes: LD Laboratory Director, CC Clinical Consultant, TC Technical Consultant (M), TS Technical Supervisor (H), GS General Supervisor (H), TP Testing Personnel, CT/GS Cytology General Supervisor and CT Cytotechnologist.
Personnel table
Last name, first name and middle initial, a column for each position held, an M or H column for the highest qualification, and a qualifications according to subpart M column for official use.
Continuation sheets
A box to check if more space is needed. The form says to copy the page and attach continuation sheets to the original form, with a page ___ of ___ line.
Items 5 to 7: certification
The laboratory director's signature, printed name and date under a certification citing 42 CFR part 493 subpart M, after a false statements warning from 18 U.S.C. 1001.
Page 2: specialty list and example
A list of 17 specialties, from Bacteriology to Clinical Cytogenetics, used for TC and TS entries, and an example showing how to fill in the table.
How to fill out Form CMS-209
- 1
Enter the laboratory details
Fill in items 1 to 3: laboratory name, CLIA identification number and address.
- 2
List the testing personnel
List everyone with testing responsibilities in the last two years, leaving out people who only do specimen processing, clerical work, waived or no testing.
- 3
Mark positions and specialties
Check the column for each position held, using a separate line for each CLIA position. For TC and TS, write the specialty number from the page 2 list, one line per specialty.
- 4
Mark M or H
Indicate each person's highest level of qualification: M for moderate and H for high complexity.
- 5
Add continuation sheets if needed
If the table runs out of room, check the box, copy the page and attach the continuation sheets, numbering the pages.
- 6
Director signs the certification
The laboratory director signs, prints their name and dates items 5 to 7.
Why fill Form CMS-209 on indox
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- The official blank straight from the CMS, not a copy someone retyped
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What the form and the CMS page say
Where it goes
The form prints no mailing address. Its CMS notice says to contact [email protected] with questions about where to submit documents.
Official use only
The date of survey and the qualifications according to subpart M column are marked not to be completed by the laboratory.
OMB number and expiration
OMB No. 0938-0151, which the form says expires 08/31/2028.
Time to complete
The form estimates an average of 30 minutes per response. The CMS address in its Paperwork Reduction Act notice is for comments on that estimate, not for the form.
Related forms
CMS-116
CLINICAL LABORATORY IMPROVEMENT AMENDMENTS OF 1988 (CLIA) APPLICATION FOR CERTIFICATION
297 fields, 10 pages
CMS-1557
SURVEY REPORT FORM - CLIA
294 fields, 4 pages
CMS-2567
STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION
22 fields, 5 pages
CMS-1539
MEDICARE/MEDICAID CERTIFICATION AND TRANSMITTAL
51 fields, 2 pages
Who uses Form CMS-209?
The form says the laboratory completes it and the surveyor uses it.
Official sources and the blank
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Questions about Form CMS-209
Who should be listed on Form CMS-209?
The form says to list all personnel with responsibilities for testing in the last two years. It says not to list personnel who only perform specimen processing, clerical functions, waived or no testing.
Which positions are listed for each complexity level?
The form says LD, CC, TC and TP for moderate complexity, LD, CC, TS, GS and TP for high complexity, and LD, CC, TS, CT/GS and CT for cytology.
What if one person holds more than one position?
The form says to use a separate line for personnel holding more than one CLIA position, and a separate line for each specialty when someone is a TC or TS in more than one.
What do M and H mean on Form CMS-209?
They mark each person's highest level of qualification: M for moderate and H for high complexity.
How many laboratory directors can be listed?
The form says only one person may be listed as the laboratory director.
What if there are too many people for one page?
The form says to check the box, copy the page and attach continuation sheets to the original form, then fill in the page ___ of ___ line.
Who signs Form CMS-209?
The laboratory director signs a certification that all individuals listed qualify for the positions shown under 42 CFR part 493 subpart M.