[Federal Register Volume 86, Number 74 (Tuesday, April 20, 2021)]
[Notices]
[Pages 20496-20497]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08117]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Assisted Reproductive Technology (ART) Success Rates Reporting 
and Data Validation Procedures

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Final notice.

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SUMMARY: The Centers for Disease Control and Prevention, within the 
Department of Health and Human Services, announces the changes in 
assisted reproductive technology (ART) data validation selection 
process; data validation approach; and data discrepancy reporting. The 
proposed changes to ART data validation were published in the Federal 
Register on October 20, 2020 (85 FR 66566); public comments and 
recommendations were requested, and no comments were received. This 
notice describes changes to the data validation process that will be 
implemented effective for calendar year 2022.

FOR FURTHER INFORMATION CONTACT: Jeani Chang, Division of Reproductive 
Health, National Center for Chronic Disease Prevention and Health 
Promotion, Centers for Disease Control and Prevention, 4770 Buford 
Highway NE, Mailstop S107-2, Atlanta, Georgia 30341-3724. Telephone: 
(770) 488-5200. Email: [email protected].

SUPPLEMENTARY INFORMATION: Pursuant to the Fertility Clinic Success 
Rate and Certification Act of 1992, 42 U.S.C. 263a-5, CDC publishes 
pregnancy success rates reported to the agency in accordance with 
section 263a-1(a)(1). The primary goal of public reporting of clinical 
outcomes of ART is to provide accurate data to current or potential ART 
users. Therefore, multiple mechanisms ensuring data accuracy are 
employed by CDC: Conducting data checks for logical errors and 
inconsistencies during data entry stage, verification of data accuracy 
by clinics' medical directors, additional data checks for logical 
errors and internal inconsistencies after submission. If any

[[Page 20497]]

errors or inconsistencies are identified during these stages, clinics 
are contacted and data are immediately corrected. In addition, CDC 
conducts annual site visits by selecting 7-10% of all reporting clinics 
and about 70-80 cycles per clinic for data validation. This data 
validation process involves comparing information of key variables from 
patient's medical record with the data submitted to the National ART 
Surveillance System (NASS), the CDC data reporting system for ART 
procedures, to calculate discrepancy rates for these variables. Data 
validation helps ensure that clinics submit accurate data and to 
identify any systematic problems that could cause data collection to be 
inconsistent or incomplete.

Data Validation

    CDC is currently conducting data validation using stratified random 
sampling of reporting clinics to assess discrepancy rates for key 
variables that are generalizable for all reporting clinics as described 
in ``Reporting of Pregnancy Success Rates from Assisted Reproductive 
Technology (ART) Programs'' (80 FR 51811). Effective for calendar year 
2022, CDC also will conduct targeted validation of clinics to better 
capture systematic reporting errors by assessing certain reporting 
characteristics that may predict erroneously inflated ART success rates 
(e.g. number of cancelled cycles, inability to confirm reported live 
births, etc.). Information gained from targeted validation will be used 
to identify and address systematic reporting errors, but will not be 
used in calculating discrepancy rates since it cannot be generalized to 
all reporting clinics.
    If a clinic is selected to participate in the NASS data validation 
process (either through stratified random sampling or through targeted 
selection), participates in validation, and major data discrepancies 
are identified (e.g., lack of supporting information for a significant 
proportion of reported pregnancy outcomes, inability to confirm a 
significant proportion of reported live births, underreporting a 
significant proportion of cycles, etc.), a message will be displayed in 
the ART Fertility Clinic Success Rates Report for the clinic as:

    CDC conducts data validation of a sample of reporting clinics to 
assess discrepancy rates for key variables, to identify any 
systematic problems, and to help ensure clinics submit accurate 
data. This clinic was visited for validation of (insert: Reporting 
year) data and major data discrepancies were identified. This 
clinic's reported success rates data are therefore not published in 
this report and not included in aggregate national data reports.

    CDC may re-select this ART program during the following reporting 
year(s) to assess corrections of identified data errors.
    In addition, CDC will publish a statement in the annual ART 
Fertility Clinic Success Rates Report to identify clinics that are 
selected by CDC to participate in the NASS data validation but decline 
to participate.(See 80 FR 51811 for further information concerning 
external validation of clinic data). If a clinic is selected to 
participate in the NASS data validation process and declines to 
participate, the following message will be displayed in the ART 
Fertility Clinic Success Rates Report for the clinic as:

    CDC conducts data validation of a sample of reporting clinics to 
assess discrepancy rates for key variables, to identify any 
systematic problems, and to help ensure clinics submit accurate 
data. This clinic was selected for validation of (insert: Reporting 
year) data, but declined to participate. This clinic's reported data 
are therefore not published in this report and not included in 
aggregate national data reports.

    CDC may re-select this ART program during the following reporting 
year(s). Participation in data validation is integral to helping ensure 
the accuracy of the required pregnancy success rates reported to have 
been achieved by clinics. Therefore, displaying this message, as well 
as the other messages outlined herein, is important in providing the 
public with the most accurate information.
    For consistency, for all other clinics that are selected to 
participate in the NASS data validation and do participate, the 
following footnote will be added:

    CDC conducts data validation of a sample of reporting clinics to 
assess discrepancy rates for key variables, to identify any 
systematic problems, and to help ensure clinics submit accurate 
data. This clinic was visited for validation of (insert: Reporting 
year) data and no systematic problems were identified.

    Any messages added to a clinic's success rates page in the ART 
Fertility Clinic Success Rates Report will appear only for the 
reporting year that the clinic was selected for validation. These 
enhanced processes and messages in the annual ART Fertility Clinic 
Success Rates Report will help to inform the public if there are issues 
with data quality, thereby increasing the transparency and help ensure 
the accuracy of the NASS data reporting.

    Dated: April 15, 2021.
Sandra Cashman,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2021-08117 Filed 4-19-21; 8:45 am]
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