Laboratory Personnel CMS-209 Form PDF Details

In the realm of laboratory operations within the United States, ensuring the competency and qualification of laboratory personnel is paramount. The Laboratory Personnel Report, known formally as the CMS 209 form, plays a critical role in this process. Mandated by the Centers for Medicare & Medicaid Services (CMS) under the Department of Health and Human Services, this document serves as a comprehensive record of the technical personnel employed by laboratories that perform moderate and high complexity testing. Laboratories are required to list each staff member, their designated positions, and the highest level of testing they are qualified to perform, distinguishing between moderate (M) and high (H) complexity testing categories. This report is integral to the Clinical Laboratory Improvement Amendments (CLIA) survey process, allowing surveyors to verify the qualifications of technical personnel against the standards set forth in 42 CFR Part 493 Subpart M. With a stringent emphasis on accuracy and accountability, the form also carries a warning against the falsification of information, highlighting the legal repercussions such actions might entail. Completion of the form, therefore, becomes an exercise of both compliance and ethical responsibility, ensuring that laboratories maintain a workforce capable of delivering accurate and reliable test results.

QuestionAnswer
Form NameLaboratory Personnel CMS-209 Form
Form Length2 pages
Fillable?Yes
Fillable fields199
Avg. time to fill out20 min 11 sec
Other namescms personnel, form 209 search, form cms 209, cms 209 form

Form Preview Example

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Form Approved

CENTERS FOR MEDICARE & MEDICAID SERVICES

OMB No. 0938-0151

LABORATORY PERSONNEL REPORT (CLIA)

(For moderate and high complexity testing)

1. LABORATORY NAME

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2. CLIA IDENTIFICATION NUMBER

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3. LABORATORY ADDRESS (NUMBER AND STREET)

 

 

CITY

 

 

 

 

STATE

 

ZIP CODE

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4. INSTRUCTIONS:

 

 

 

 

POSITIONS:

 

 

 

 

5. TELEPHONE (INCLUDE AREA CODE)

a. List below all technical personnel, by name, who are employed by the

 

D-Director

 

 

 

 

 

 

 

laboratory. Check (4) the appropriate column for each position held. For TC

 

CC - Clinical Consultant

 

 

 

 

 

 

 

and TS follow instructions on reverse. For a moderate complexity laboratory,

 

TC - Technical Consultant

 

 

 

 

 

 

 

 

TS - Technical Supervisor

 

 

 

 

 

FOR OFFICIAL USE ONLY

list the positions of D, CC, TC and TP. For a high complexity laboratory, list the

 

 

 

 

 

GS - General Supervisor

 

 

 

 

(NOT TO BE COMPLETED BY LABORATORY)

positions of D, CC, TS, GS and TP. For cytology, list D, CC, TS, CT/GS and CT.

 

 

 

 

 

 

TP- Testing Personnel

 

 

 

 

 

 

 

 

 

QUALIFIES ACCORDING TO SUBPART M

b. Indicate highest level of testing for which personnel are qualified: Use (M) for

CT/GS - Cytology General Supervisor

 

 

 

 

 

moderate and (H) for high complexity.

 

 

 

CT - Cytotechnologist

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

DATE OF SURVEY ___________________________

 

 

 

 

 

a.

 

 

 

b.

 

 

 

 

 

 

 

 

 

 

 

 

EMPLOYEE NAMES

 

 

POSITION HELD

 

 

 

M

 

 

 

LAST NAME

FIRST NAME

MI

D CC

TC

TS

 

GS

 

TP

 

CT/GS

 

CT

 

OR

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

H

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

oCheck (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. DATE

FORM CMS-209 (09/2018)

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 a moderate complexity laboratory, list the positions of D, CC, TC and TP. For a high complexity laboratory, 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 line for each specialty/subspecialty.

GRID:

 

DEPARTMENT OF HEALTH AND HUMAN SERVICES

 

CENTERS FOR MEDICARE & MEDICAID SERVICES

10. Clinical Cytogenetics

1. Bacteriology

 

2.

LABORATORY PERSONNEL REPORT (CLIA)

 

Mycobacteriology

11.

Histocompatibility

 

3.

Mycology

(For moderate and high complexity testing)

 

 

12.

Radiobioassay

1. LABORATORY NAME

Parasitology

 

13.

Histopathology

 

4.

 

 

5.

Virology

 

14.

Oral Pathology

3. LABORATORY ADDRESS (NUMBER AND STREET)

 

CITY

 

6.

Diagnostic Immunology

15.

Cytology

4. INSTRUCTIONS:

7. Chemistry

 

16.

PDermatopathologyOSITIONS:

a. List below all technical personnel, by name, who are employed by the

17.

D-Director

 

8.

Hematology

 

CCOphthalmic- Clinical ConsultantPathology

laboratory. Check (4) the appropriate column for each position held. For TC

 

TC - Technical Consultant

and TS follow instructions on reverse. For moderate complexity laboratory,

 

 

9.

Immunohematology

 

TS - Technical Supervisor

list the positions of D, CC, TC and TP. For a high complexity laboratory, list the

GS - General Supervisor

positions of D, CC, TS, GS and TP. For cytology, list D, CC, TS, CT/GS and CT.

 

 

TP- Testing Personnel

b. Indicate highest level of testing for which personnel are qualified: Use (M) for

CT/GS - Cytology General Supervisor

EXAMPLEmoderate and (H) for high complexity.

 

 

CT - Cytotechnologist

Form Approved

OMB No. 0938-0151

2. CLIA IDENTIFICATION NUMBER

STATE

ZIP CODE

5.TELEPHONE (INCLUDE AREA CODE)

FOR OFFICIAL USE ONLY

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

 

 

 

a.

 

 

 

 

b.

DATE OF SURVEY ___________________________

 

 

 

 

 

 

 

 

 

EMPLOYEE NAMES

 

POSITION HELD

 

 

 

 

M

 

LAST NAME

FIRST NAME

MI

D CC TC TS

 

GS

 

TP

 

CT/GS

 

CT

OR

 

 

 

 

 

 

 

 

 

 

H

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Smith

John

 

1

 

 

 

 

 

 

 

 

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: 9/30/2021. 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.

*****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 LabExcellence@cms.hhs.gov.

FORM CMS-209 (09/2018)

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