Form CMS-209 Laboratory Personnel Report (CLIA)

Laboratory Personnel Report (CLIA) and Supporting Regulations (CMS-209)

CMS209

Laboratory Personnel Report (CLIA) and Supporting Regulations in 42 CFR 493.1 - 493.2001

OMB: 0938-0151

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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:

LAST NAME

FIRST NAME

MI

D

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. 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.
b. Indicate whether shift worked is (1) day, (2) evening or (3) night.
c. Indicate highest level of testing for which personnel are
qualified: Use (M) for moderate and (H) for high complexity.
d. Indicate whether position held is full (F) or part-time (P).

EMPLOYEE NAMES

CITY

a.

b.

POSITION HELD

S 1
H
I 2
F
T 3

CC TC TS GS TP

CT/GS

CT

ZIP CODE

FOR OFFICIAL USE ONLY

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

c.
M

d.
F

OR

OR

H

P

DATE OF SURVEY ___________________________

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

FORM CMS-209 (09/92)

7. 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 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 line for each specialty/subspecialty.

GRID:
1.
2.
3.
4.
5.
6.
7.
8.
9.

Bacteriology
Mycobacteriology
Mycology
Parasitology
Virology
Diagnostic Immunology
Chemistry
Hematology
Immunohematology

10.
11.
12.
13.
14.
15.
16.
17.

Clinical Cytogenetics
Histocompatibility
Radiobioassay
Histopathology
Oral Pathology
Cytology
Dermatopathology
Ophthalmic Pathology

EXAMPLE
a.

EMPLOYEE NAMES
LAST NAME

FIRST NAME

Smith

John

b.

POSITION HELD
MI

D CC TC TS

GS TP

CT/GS

CT

S
H
I
F
T

1

1

c.
M

d.
F

2

OR

OR

3

H

P

M

F

1

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. 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 the 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.
FORM CMS-209 (09/92)


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File Modified2011-11-08
File Created2008-02-26

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