CMS-1557 Survey Report Form (CLIA)

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

FORM APPROVED
OMB NO. 0938-0544

SURVEY REPORT FORM (CLIA)

SURVEYOR INSTRUCTIONS FOR CMS 1557
•
•
•

For specialty(ies)/subspecialty(ies) added or deleted: Use the space provided to list corresponding information and effective dates.
For proficiency testing: Any comments pertinent to the survey or determination of compliance can be listed here.

Each surveyor must sign the certifying statement on page 2 for each type of survey conducted (see “survey status;” “other” may include
follow-up visit to verify a POC).

GENERAL INFORMATION
CLIA IDENTIFICATION NUMBER

DATE OF SURVEY

LABORATORY NAME

TELEPHONE NUMBER (include area code)

LABORATORY ADDRESS (number, street)

CITY

STATE

ZIP

MAILING ADDRESS (if different from above)

CITY

STATE

ZIP

NAME OF DIRECTOR
last

first

SURVEY STATUS: (Check all that apply)

MI

STATE/COUNTY CODE

… Initial Certification

… State Exemption (State) ___________________________

… Recertification

… Accreditation (Organization) ________________________

… Validation

… Addition of (Sub)Specialty(ies) ______________________

… Complaint

… Other (Specify) __________________________________

STATE REGION CODE

STATE LICENSE NUMBER (if applicable)
MEDICARE PROVIDER NUMBER(S)

PERSONNEL: SHOW NUMBER OF PEOPLE QUALIFIED UNDER EACH APPLICABLE REGULATORY SECTION
DIRECTOR
MODERATE COMPLEXITY
493.1405(a) and
(b) (1)

(6)

(3)

( )

(2)

(4)

(5)

(7)

( )

(2)

(3)

(a)
(b)
( )

TECHNICAL CONSULTANT
MODERATE COMPLEXITY
493.1411(a) and
(b) (1)_______( )
(2) _______( )
(3) _______

( )

(4) _______

( )

DIRECTOR
HIGH COMPLEXITY
493.1443(a) and
(b) (1)

CLINICAL CONSULTANT
MODERATE COMPLEXITY
493.1417

( )

( )

(4)
(5)

CLINICAL CONSULTANT
HIGH COMPLEXITY
493.1455
(a)
(b)
( )
( )

TECHNICAL SUPERVISOR
HIGH COMPLEXITY 493.1449(a)
and

GENERAL SUPERVISOR
HIGH COMPLEXITY 493.1461(a)
and

(c)

(b)(1)

(d)(1)

(b)(2)

(d)(2)

(c)(1)

(d)(3)

(c)(2)

(e)

(c)(3)

( )

(b)

(j)

(f)

(l)

(g)

(b) (1)
(2)

(3)

(4)
(5)

( )

(i)

(d)
(e)

CYTOTECHNOLOGIST
493.1483(a) and

(h)

(*)

(m)

(n)
(o)

(p)

(q)

( )
( )

TECHNICAL SUPERVISOR
CYTOLOGY *493.1449(a) and
(k) (1) _______( )
(2) _______( )

GENERAL SUPERVISOR
CYTOLOGY 493.1469
(a)
(b)

( )
( )

According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid 0MB control
number. The valid 0MB control number for this information collection is 0938-0544. 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 any 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 [email protected].
FORM CMS-1557 (02/2021)

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SPECIALTIES/SUBSPECIALTIES
■
■
■
■
■
■
■
■
■
■
■
■
■
■
■
■
■
■
■
■
■
■
■

010
A
B
100
110
115
120
130
140
150
200
210
220
300
310
320
330
340
350
400
500
510
520

530 ■

Histocompatibility
Transplant
Nontransplant
Microbiology
Bacteriology
Mycobacteriology
Mycology
Parasitology
Virology
Other
Diagnostic Immunology
Syphilis Serology
General Immunology
Chemistry
Routine
Urinalysis
Endocrinology
Toxicology
Other
Hematology
Immunohematology
ABO Group & Rh Type
Antibody Detection
(transfusion)
Antibody Detection
(nontransfusion)
Antibody Identification
Compatibility Testing
Other
Pathology

■
■
■
■
■
Histopathology
■
Oral Pathology
■
Cytology
■ Radiobioassay
■ Clinical Cytogenetics

540
550
560
600
610
620
630
800
900

(SUB)SPECIALTY(IES) (SUB)SPECIALTY(IES)
PROFICIENCY
ADDED
DELETED
TESTING
EFFECTIVE DATE
EFFECTIVE DATE

ACCREDITED
PROGRAM

ANNUAL TEST
VOLUMES

__________

_________

______________

_____________

NA

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_________
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______________
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______________

_____________
_____________
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_____________
_____________
_____________
_____________
_____________
_____________

_________
_________
_________
_________
NA
NA
_________
NA
NA

_________

_________

_________
_________

_________

_________
_________

Are immunohematology tests performed for transfusion purposes? ......................................................................................... ■ Yes
■ No
Are blood and/or blood products (including autologous) collected? .......................................................................................... ■ Yes
■ No
For a partial survey (validation, addition of (sub)specialty, complaint, or follow-up) list the laboratory condition(s) regulation number(s)
reviewed:
________________________

________________________

________________________

________________________

________________________

________________________

________________________

________________________

________________________

In accordance with current survey procedures, this laboratory was found to be in compliance with program requirements.
SIGNATURE

DATE

SIGNATURE

DATE

SIGNATURE

DATE

FORM CMS-1557 (02/2021)

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SURVEY WORKSHEET (CLIA)
NAME OF SURVEYOR

DATE OF SURVEY (MMDDYY)

NAME OF FACILITY

CLIA IDENTIFICATION NUMBER

FORM CMS-1557 (02/2021)

PAGE ______ OF________

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SURVEY WORKSHEET (CLIA) (CONTINUED)

FORM CMS-1557 (02/2021)

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