Form 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)
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. 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.

SURVEYOR INSTRUCTIONS FOR CMS 1557

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•
•

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)

■

Initial Certification

■

Recertification

■

Validation

■

Complaint

MI
STATE REGION CODE

STATE/COUNTY CODE

■
■

State Exemption (State) ______________________

■
■

Addition of (Sub)Specialty(ies)

_______________________

______________________

Other (Specify) _____________________________

_______________________

______________________

_______________________

______________________

Accreditation (Organization) ___________________
_________________________________________

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

CLINICAL CONSULTANT
MODERATE COMPLEXITY
493.1417

TECHNICAL CONSULTANT
MODERATE COMPLEXITY
493.1411(a) and

(b)(1) ________ (6) ________
(2) ________ (7) ________
(3) ________ ( ) ________
(4) ________ ( ) ________
(5) ________ ( ) ________
DIRECTOR
HIGH COMPLEXITY
493.1443(a) and

(a) ________

b) (1) ________ ( ) ________

(b) ________

(2) ________ ( ) ________

( ) ________

(3) ________

( ) ________

(4) ________

CLINICAL CONSULTANT
HIGH COMPLEXITY
493.1455

(b)(1) _______ ( ) _______
(2) _______ ( ) _______
(3) _______
(4) _______
(5) _______

(a) ________
(b) ________
( ) ________
( ) ________
CYTOTECHNOLOGIST
493.1483(a) and

GENERAL SUPERVISOR
TECHNICAL SUPERVISOR
HIGH COMPLEXITY
HIGH COMPLEXITY
493.1461(a) and
493.1449(a) and
(b) ______ (h) ______ (n) ______ (b)(1) _______ (d)(1) _______
(c) ______ (i) ______ (o) ______
(b)(2) _______ (d)(2) _______
(d) ______ (j) ______ (p) ______
(e) ______ (*)______ (q) ______ (c)(1) _______ (d)(3) _______
(f) ______ (l) ______ ( ) ______ (c)(2) _______ (e) _________
(g) ______ (m) ______ ( ) ______
TECHNICAL SUPERVISOR
CYTOLOGY
*493.1449(a) and

(c)(3) _______ ( ) _________
GENERAL SUPERVISOR
CYTOLOGY
493.1469

(b)(1) _______ (4) _______
(2) _______ (5) _______
(3) _______ ( ) _______
FORM CMS-1557 (9-92)

(k)(1) _______ ( ) _______

(a) _______ ( ) _______

(2) _______ ( ) _______

(b) _______ ( ) _______
PAGE 1

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

530 ■
540 ■
550 ■
560 ■
600 ■
610 ■
620 ■
630 ■
800 ■
900 ■

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

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

ACCREDITED
PROGRAM

ANNUAL TEST
VOLUMES

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_________

______________

_____________

NA

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_________
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NA
NA
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NA
NA

_________

_________

_________
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_________

_________
_________

Are immunohematology tests performed for transfusion purposes? ......................................................................................... ■ Yes
■ No
■ No
Are blood and/or blood products (including autologous) collected? .......................................................................................... ■ Yes
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 (9-92)

PAGE 2

SURVEY WORKSHEET (CLIA)
NAME OF SURVEYOR

DATE OF SURVEY (MMDDYY)

NAME OF FACILITY

CLIA IDENTIFICATION NUMBER

FORM CMS-1557 (9-92)

PAGE ______ OF________

PAGE 3

SURVEY WORKSHEET (CLIA) (CONTINUED)

FORM CMS-1557 (9-92)

PAGE 4