Assisted Reproductive Technology (ART) Success Rates Reporting and Data Validation Procedures
| Published date | 20 April 2021 |
| Citation | 86 FR 20496 |
| Record Number | 2021-08117 |
| Section | Notices |
| Court | Centers For Disease Control And Prevention,Health And Human Services Department |
Federal Register, Volume 86 Issue 74 (Tuesday, April 20, 2021)
[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]
BILLING CODE 4163-18-P
