Form CMS-209 Laboratory Personnel Report (CLIA)

Form Approved
OMB No. 0938-0151

DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES

LABORATORY PERSONNEL REPORT (CLIA)
(For moderate and high complexity testing)

1. LABORATORY NAME

2. CLIA IDENTIFICATION NUMBER

3. LABORATORY ADDRESS (NUMBER AND STREET)
4. Instructions:

a. List below all technical personnel, by name, who are employed by the laboratory. Check
(4) the appropriate column for each position held. For TC and TS follow instructions on
reverse. For laboratories performing moderate complexity testing, list the positions of D,
CC, TC and TP. For laboratories performing high complexity testing, list the positions of D,
CC, TS, GS and TP. For cytology, list D, CC, TS, CT/GS and CT.
b. Indicate highest level of testing for which personnel are qualified: Use (M) for moderate
and (H) for high complexity.

CITY

STATE

Positions:

5. TELEPHONE (INCLUDE AREA CODE)

D - Director
CC - Clinical Consultant
TC - Technical Consultant
TS - Technical Supervisor
GS - General Supervisor
TP - Testing Personnel
CT/GS - Cytology General Supervisor
CT - Cytotechnologist

a.

LAST NAME

FIRST NAME

MI

D

CC TC TS GS TP

FOR OFFICIAL USE ONLY

(NOT TO BE COMPLETED BY LABORATORY)
QUALIFIES ACCORDING TO SUBPART M

b.
M

POSITION HELD

EMPLOYEE NAMES

CT/GS

CT

ZIP CODE

DATE OF SURVEY ___________________________

OR

H

o Check (4) here if additional space is needed to list all technical personnel. Copy this page and attach continuation sheet(s) to the original form.
READ THE FOLLOWING CAREFULLY BEFORE SIGNING
Statement or Entities Generally: Whoever, in any manner within the jurisdiction of any department or agency of the United States
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, or makes or uses any false writing or document knowing the same to contain any false,
fictitious or fraudulent statements or entry, shall be fined not more than $10,000 or imprisoned not more than five years, or both.
(U.S. Code, Title 18, Sec. 1001)
CERTIFICATION: I 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.
6. SIGNATURE OF LABORATORY DIRECTOR
7. PRINTED NAME OF LABORATORY DIRECTOR

FORM CMS-209 (01/2021)

8. DATE

IF CONTINUATION SHEET PAGE ___ OF ___

INSTRUCTIONS FORM CMS-209
This form will be completed by the laboratory. It will be used by the surveyor to review the qualifications of
technical personnel in the laboratory.
Instructions
1. Only one person may be listed as the laboratory director (D).
2. For laboratories performing moderate complexity testing, list the positions of D, CC, TC and TP. For
laboratories performing high complexity testing, list the positions of D, CC, TS, GS and TP. For cytology, list
D, CC, TS, CT/GS and CT.
3. Do not list individuals that only perform waived testing, no testing, and administrative functions.
4. Use a separate line for individuals performing more than one CLIA position.
5. For 4(a) TC/TS:
When listing those individuals holding technical consultant/technical supervisor (TC/TS) positions, use the
following grid to indicate the specialty(ies)/subspecialty(ies) in which they presently function. Record the
number corresponding to the specialty/subspecialty in the appropriate column (TC/TS). When an individual
functions as a TC/TS in more than one specialty/subspecialty, use a separate line for each specialty/
subspecialty.
GRID:
1. Bacteriology
[42 CFR 493.1449(c)]
2. Mycobacteriology
[42 CFR 493.1449(d)]
3. Mycology [42 CFR 493.1449(e)]
4. Parasitology
[42 CFR 493.1449(f)]
5. Virology [42 CFR 493.1449(g)]
6. Diagnostic Immunology
[42 CFR 493.1449(h)]

7. Chemistry [42 CFR 493.1449(i)]
8. Hematology
[42 CFR 493.1449(j)]
9. Immunohematology
[42 CFR 493.1449(q)]
10. Clinical Cytogenetics
[42 CFR 493.1449(p)]
11. Histocompatibility
[42 CFR 493.1449(o)]
12. Radiobioassay

[42 CFR 493.1449(n)]
13. Histopathology
[42 CFR 493.1449(l)]
14. Oral Pathology
[42 CFR 493.1449(m)]
15. Cytology [42 CFR 493.1449(k)]
16. Dermatopathology
[42 CFR 493.1449(l)(2)]
17. Ophthalmic Pathology
[42 CFR 493.1449(l)(3)]

EXAMPLE
a.

POSITION HELD

EMPLOYEE NAMES
LAST NAME

Smith

FIRST NAME

John

b.
M

MI

D

CC TC TS GS TP

1

CT/GS

CT

DATE OF SURVEY ___________________________

OR

H

M
4

H

6

H

FOR OFFICIAL USE ONLY
Indicate the applicable regulatory citation under which the following individuals are qualified: Each laboratory
director, technical consultant, technical supervisor, clinical consultant, general supervisor, cytology supervisor, and
those testing personnel and cytotechnologist sampled during the survey process.
According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control
number. The valid OMB control number for this information collection is 0938-0151. Expiration Date:XX/XX/20XX. 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. If you have comments concerning the accuracy of time estimate(s) or suggestions for improving this form, please
write to: CMS, 7500 Security Boulevard, Attn: PRA Reports Clearance Officer, Mail Stop C4-26-05, Baltimore, Maryland 21244-1850.
*****CMS Disclaimer*****Please do not send applications, claims, payments, medical records or any documents containing sensitive information to the PRA
Reports Clearance Office. Please note that any correspondence not pertaining to the information collection burden approved under the associated OMB control
number listed on this form will not be reviewed, forwarded, or retained. If you have questions or concerns regarding where to submit your documents, please
contact [email protected].
FORM CMS-209 (09/2018)