Background
The Clinical Laboratory Improvement Amendments of 1988 (CLIA), Public Law 100-578, was enacted on October 31, 1988. CLIA established a new section 353 of the Public Health Service Act to replace the existing section 353. Section 353 requires the Department of Health and Human Services (HHS) to establish certification requirements for any laboratory that performs tests on human specimens, and to certify through the issuance of a certificate that those laboratories meet the requirements established by HHS. Also, the legislation contains certificate requirements and specifies circumstances that permit certificates of waiver to be issued. The law also includes requirements for inspections, sanctions, judicial review, fees and disclosure of information to the public.
Section 6141 of the Omnibus Budget Reconciliation Act of 1989 (OBRA ‘89), Public
Law 101-239, requires that laboratories participating in the Medicare program comply with CLIA requirements. Subject to specified exceptions, laboratories must have a current unrevoked and unsuspended certificate to operate and to be eligible for reimbursement in the Medicare or Medicaid programs or both.
Final CLIA regulations (with comment) were published in the Federal Register on February 28, 1992. Compliance surveys of laboratories began September of 1992. The law provides for inspections on an announced or unannounced basis during regular hours of operation. In conducting such inspections, all records and information having a bearing on whether the laboratory is being operated in accordance with the law can be requested by the surveyor. These inspections are conducted on a biennial basis.
For this submission, we are making no revisions to the collection instrument.
Need and Legal Basis
The information collected on this survey form is used in the administrative pursuit of the Congressionally-mandated program with regard to regulation of laboratories participating in CLIA.
Legislative regulatory authority for this activity is Public Law 100-578.
To determine compliance, the Secretary has authorized States [in Section 1864(a) of the Social Security Act] through contracts to conduct surveys of laboratories under CLIA. In order for the State survey agency to report to the Centers for Medicare & Medicaid Services (CMS) its findings on facility compliance with the individual standards on
which CMS determines compliance, the surveyor completes the Survey Report Form (CLIA) (CMS-1557).
To facilitate validation of information submitted by the laboratory to CMS, the CMS-1557 follows the format of the CLIA application (CMS-116,
OMB Number: 0938-0581) where possible. This form will require an estimated range from 5 minutes to 60 minutes to complete. This is based on information available in the Regulatory Impact Analysis of HSQ-176-FC. There are approximately 15,975 laboratories in the CLIA data base that require a State survey for CLIA compliance. An average time of 30 minutes for form completion was used.
Portions of the form will be filled out prior to the onsite survey (e.g., general information, survey status, State license number, State/county/State region code, Medicare provider number, personnel, specialties/subspecialties, accredited program, annual test volume) and verified onsite. As necessary, the surveyor will enter the addition or deletion of specialty/subspecialty testing and the appropriate effective date. The surveyor can record pertinent proficiency testing information (i.e., program, score, unsuccessful participation for an analyte, etc.) in the column provided.
Information Users
CMS-1557 is used to report surveyor findings during a CLIA survey. For each type of survey conducted (i.e., initial certification, recertification, validation, complaint, addition/deletion of specialty/subspecialty, transfusion fatality investigation, or revisit inspections), the Survey Report Form (CLIA) incorporates requirements as specified by the CLIA regulations. The laboratory surveyor uses the CMS-1557 to record the number of personnel and the positions they serve under CLIA (i.e., laboratory director, technical consultant, clinical consultant, technical supervisor, general supervisor, cytology general supervisor, cytotechnologist, and testing personnel), the CLIA specialties and subspecialties performed in the laboratory and pertinent proficiency testing information.
Use of Information Technology
The form is available electronically on the CMS Internet at http://www.cms.hhs.gov/forms/. The majority of the information is captured electronically in the Automated Survey Processing Environment (ASPEN) system. However, a few are collected as a hardcopy.
Duplication of Efforts
Information (general, specialty/subspecialty, accredited program, and annual test volume) collected on the application is validated by the inspection process. The number of people qualified under each applicable regulatory section, addition/deletion of
specialty/subspecialty and effective dates, and proficiency testing data is not collected on any other CLIA survey report form.
Small Business
These requirements do not significantly affect small businesses. We believe that the number of small business entities is similar to the number of low volume A CLIA certificate of compliance facilities. As of May 2021, there are 5,658 low volume A CLIA certificate of compliance facilities. To reduce impact to small businesses, the form was designed to only collect the information necessary to establish compliance with the CLIA regulations.
Less Frequent Collection
Under CLIA, laboratories are required to be surveyed once every 2 years. If this information would be collected less frequently, the CLIA survey findings would be negatively impacted.
Special Circumstances for Information Collection
There are no special circumstances associated with this collection.
Federal Register/Outside Consultation
The 60-day Federal Register notice published on August 20, 2021 (86 FR 46854). There were no public comments received.
The 30-day Federal Register notice published on November 1, 2021 (86 FR 60244).
The publication of this notice was used to solicit outside consultation. No other outside consultation was sought.
Payments or Gifts to Respondents
There are no payments or gifts to respondents associated with this collection.
Confidentiality
We do not pledge confidentiality.
Sensitive Questions
There are no questions of a sensitive nature associated with these forms.
Burden Estimates
This form contains information necessary for the surveyor to determine compliance with CLIA. We anticipate the time requirement for completion of this form to range between 5 and 60 minutes. The average length of time to report this information is 30 minutes.
Since CLIA surveys are biennial (i.e., a CLIA survey occurs once every two years), the annual frequency is 0.5 times a year per laboratory respondent. Based on the number of laboratory respondents as 15,975 the following computations are appropriate.
Hourly Burden Computation
15,975 (laboratories) (biennial review)/2 = 7,987.5 laboratories per year X 0.50 hours per response = 3,994 annual burden hours
Wage Burden computation
We estimated that the Federal costs involved in collecting the CMS-1557 information for administering the CLIA program would be based on an employee earning an average of
$72.58 per hour. The tasks involved range from collecting the information, reviewing the information collected and then entering the data into the CLIA data system. We estimate that these tasks would be completed by a Federal employee at the GS-12 grade level. According to the 2021 GS Salary Table, as shown on opm.gov’s web site (https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/pdf/2021/GS_h.pdf), the salary for a GS-12 employee ranges from $32.02 through $41.63. We selected the mid-range hourly wage of $36.29 and included a 100% fringe.
Annual Cost Burden Computation
3,994 annual burden hours X $72.58 = $289,885
Capital Costs
There is no capital cost associated with this collection.
Cost to Federal Government
There is no cost estimate to the Federal Government.
Changes in Burden/Program Changes
Changes in burden are the result of decrease in the number of respondents in the CLIA program and an increase in the ICR. The respondents decreased from 19,183 to 15,975. The burden hours decreased from 4796 to 3,994. The wage rate increased from $29.00 to $36.29 thus the total costs increased from $139,084. to $289,885. There are no program changes.
Publication and Tabulation Dates
There are no publication and tabulation dates associated with this collection.
Expiration Date
CMS will display the expiration date on the form.
Certification Statement
There are no exceptions to the certification statement.
There are no statistical methods employed in this information collection.
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| File Title | CMS-1557 Supporting Statement 2018 |
| Author | CMS |
| File Modified | 0000-00-00 |
| File Created | 2021-11-03 |