The CMS-1557 Survey Report Form (CLIA) is an essential document used in the healthcare industry, particularly within the context of laboratory operations and regulatory compliance. This report is integral to the Clinical Laboratory Improvement Amendments (CLIA) of 1988, which set standards for all U.S. facilities or sites that test human specimens for health assessment or to diagnose, prevent, or treat disease. The CMS-1557 form is a critical component in ensuring that these laboratories adhere to the quality standards established by CLIA.

Purpose and Importance

The primary purpose of the CMS-1557 Survey Report Form is to document the findings of a CLIA inspection or survey. These surveys are conducted to assess a laboratory's compliance with CLIA regulations. The form is used by inspectors to record observations, identify deficiencies, and ensure that laboratories meet the necessary quality control, quality assurance, and safety standards required for accurate and reliable test results.

Structure and Content

The CMS-1557 form is comprehensive and designed to capture a wide range of information about the laboratory's operations. It includes sections on:

1. General Information: This includes the laboratory's name, address, CLIA number, and the type of laboratory (e.g., hospital, independent, physician office).

2. Personnel: Information about the qualifications and roles of the laboratory director, technical supervisor, and other key personnel.

3. Facilities and Equipment: Details about the laboratory's physical setup, equipment used, and maintenance records.

4. Testing Procedures and Processes: This covers the types of tests performed, methodologies used, and the processes for ensuring accuracy and reliability of test results.

5. Quality Control and Quality Assurance: Documentation of the laboratory's quality control procedures, proficiency testing results, and corrective actions taken for any identified issues.

6. Patient Test Management: Information on how specimens are collected, stored, processed, and reported.

7. Compliance with Regulatory Standards: Details on adherence to specific CLIA regulations, with notes on any deficiencies observed during the survey.

Use in Regulatory Oversight

The information captured in the CMS-1557 form is used by regulatory authorities to determine if a laboratory is in compliance with CLIA standards. If deficiencies are noted, the form will outline the specific areas where the laboratory fails to meet regulatory requirements. This can lead to corrective actions, penalties, or even suspension of the laboratory's CLIA certificate if critical deficiencies are not resolved.

Impact on Healthcare Quality

The CMS-1557 Survey Report Form plays a crucial role in maintaining high standards in laboratory testing. By ensuring that laboratories adhere to strict quality standards, the form helps protect patient safety and improves the overall reliability of laboratory diagnostics. Accurate laboratory results are fundamental to effective medical diagnosis and treatment, making the CMS-1557 a key tool in the pursuit of quality healthcare.

Conclusion

In summary, the CMS-1557 Survey Report Form (CLIA) is a vital document that supports the enforcement of quality standards in laboratories under the CLIA regulations. Its comprehensive structure allows for a detailed assessment of a laboratory's compliance with these standards, ensuring that laboratories provide accurate and reliable test results, which are essential for quality patient care. The form's role in regulatory oversight is indispensable in maintaining the integrity and efficacy of laboratory testing across the United States.

Download CMS-1557

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 MI SURVEY STATUS: (Check all that apply) STATE/COUNTY CODE STATE REGION CODE … Initial Certification … State Exemption (State) ___________________________ … Recertification … Accreditation (Organization) ________________________ … Validation … Addition of (Sub)Specialty(ies) ______________________ … Complaint … Other (Specify) __________________________________ STATE LICENSE NUMBER (if applicable) MEDICARE PROVIDER NUMBER(S) PERSONNEL: SHOW NUMBER OF PEOPLE QUALIFIED UNDER EACH APPLICABLE REGULATORY SECTION DIRECTOR CLINICAL CONSULTANT TECHNICAL CONSULTANT MODERATE COMPLEXITY MODERATE COMPLEXITY MODERATE COMPLEXITY 493.1405(a) and 493.1417 493.1411(a) and (b) (1) (6) (a) (b) (1)_______( ) (2) (7) (b) (2) _______( ) (3) ( ) ( ) (3) _______ (4) ( ) ( ) (4) _______ (5) ( ) DIRECTOR CLINICAL CONSULTANT TECHNICAL SUPERVISOR GENERAL SUPERVISOR HIGH COMPLEXITY HIGH COMPLEXITY HIGH COMPLEXITY 493.1449(a) HIGH COMPLEXITY 493.1461(a) 493.1443(a) and 493.1455 and and (b) (1) ( ) (b) (h) (n) (b)(1) (d)(1) (2) ( ) (a) (c) (i) (o) (b)(2) (d)(2) (3) (4) (5) (b) ( ) ( ) (d) (j) (p) (e) (*) (q) (f) (l) ( ) (g) (m) ( ) (c)(1) (d)(3) (c)(2) (e) (c)(3) ( ) CYTOTECHNOLOGIST TECHNICAL SUPERVISOR GENERAL SUPERVISOR 493.1483(a) and CYTOLOGY 493.1449(a) and CYTOLOGY 493.1469 (b) (1) (4) (2) (5) (k) (1)_______( ) (a) ( ) (3) ( ) (2) _______( ) (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: 06/30/2025. 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 LabExcellence@cms.hhs.gov.