Form CMS-209 at a glance
What it is: Form CMS-209 is the Laboratory Personnel Report (CLIA) for moderate and high complexity testing, completed by the laboratory for the surveyor to review the qualifications of technical personnel.
Who signs: Box 5 is the Signature of Laboratory Director.
What to bring and attach to Form CMS-209
Attach continuation sheet(s) to the original form.
A filled-in Form CMS-209 example: a laboratory lists its director and a technical consultant
How to fill out Form CMS-209, box by box
Boxes 1 to 3, the laboratory
Enter the Laboratory Name in box 1 and the CLIA Identification Number in box 2, then the Laboratory Address (Number and Street), City, State and Zip Code in box 3.
Box 4, the personnel and their positions
List all personnel with responsibilities for testing in the last two years.
Common mistake: Do not list personnel that only perform specimen processing, clerical functions, waived or no testing.
Use a separate line for personnel holding more than one CLIA position.
Check the appropriate column for each position held.
Indicate each individual's highest level of qualification: Use (M) for moderate and (H) for high complexity.
Only one person may be listed as the laboratory director.
The positions are 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.
For TC and TS use the number that corresponds with the specialty areas of responsibility, and record it in the appropriate TC or TS column.
The SPECIALTY LIST is Bacteriology, Mycobacteriology, Mycology, Parasitology, Virology, Diagnostic Immunology, Chemistry, Hematology, Immunohematology, Radiobioassay, Cytology, Histopathology, Dermatopathology, Ophthalmic Pathology, Oral Pathology, Histocompatibility and Clinical Cytogenetics.
Check (4) here if additional space is needed to list all technical personnel.
Official use only
The Date of Survey and the Qualifications According to Subpart M are for official use only and are not to be completed by the laboratory.
Boxes 5 to 7, the signature
By signing you certify that all of the individuals listed above qualify to function in the position indicated, according to the personnel regulations of 42 CFR Part 493 Subpart M.
Sign in box 5, Signature of Laboratory Director; enter the Printed Name of Laboratory Director in box 6 and the Date in box 7.
Whoever knowingly and willfully falsifies, conceals or covers up by any trick, scheme, or device a material fact, or makes false, fictitious or fraudulent statements or representations, shall be fined not more than $10,000 or imprisoned not more than five years, or both (checked October 31, 2026).
More rules for Form CMS-209
The time required to complete this information collection is estimated to average 30 minutes per response, including the time to review instructions, search existing data resources, gather the data needed, and complete and review the information collection.
Moderate, high complexity, cytology testing and other specialties
Your laboratory does moderate complexity testing
For moderate complexity testing, list the positions of LD, CC, TC and TP.
Your laboratory does high complexity testing
For high complexity testing, list the positions of LD, CC, TS, GS and TP.
Your laboratory does cytology
For cytology, list LD, CC, TS, CT/GS and CT.
One or more individuals function as a TC or TS in more than one specialty or subspecialty
Use a separate line for each specialty or subspecialty when one or more individuals function in more than one specialty or subspecialty as TC or TS.
Common questions about Form CMS-209
Where do I file it?
If you have questions or concerns regarding where to submit your documents, please contact LabExcellence@cms.hhs.gov.
Sources
[1] Form CMS-209 (09/2025), Laboratory Personnel Report (CLIA), Centers for Medicare & Medicaid Services (the Official source link on this page).