Assisted Reproductive Technology (ART) Success Rates Reporting and Data Validation Procedures
| Citation | 85 FR 66566 |
| Record Number | 2020-23188 |
| Published date | 20 October 2020 |
| Section | Notices |
| Court | Centers For Disease Control And Prevention |
Federal Register, Volume 85 Issue 203 (Tuesday, October 20, 2020)
[Federal Register Volume 85, Number 203 (Tuesday, October 20, 2020)]
[Notices]
[Pages 66566-66567]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-23188]
[[Page 66566]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket No. CDC-2020-0112]
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: Request for comment.
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SUMMARY: The Centers for Disease Control and Prevention, within the
Department of Health and Human Services, announces the opening of a
public docket to obtain public comment on proposed changes in assisted
reproductive technology (ART) data validation selection process; data
validation approach; and data discrepancy reporting.
DATES: Written comments must be received on or before December 21,
2020.
ADDRESSES: You may submit comments identified by Docket No. CDC-2020-
0112 by any of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Mail: 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. Attention: Assisted Reproduction
Technology Surveillance and Research Team.
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:
Public Participation
Interested persons or organizations are invited to participate by
submitting written views, recommendations, and data in response to the
proposed changes described in this notice. CDC invites comments
specifically on:
Proposed changes in data validation selection process;
Data validation approach; and
Process for identifying discrepancies in reporting of
pregnancy success rates from ART programs.
Please note that comments received, including attachments and other
supporting materials, are part of the public record and are subject to
public disclosure. Comments will be posted on https://www.regulations.gov. Therefore, do not include any information in your
comment or supporting materials that you consider confidential or
inappropriate for public disclosure. If you include your name, contact
information, or other information that identifies you in the body of
your comments, that information will be on public display. CDC will
review all submissions and may choose to redact or withhold submissions
containing private or proprietary information such as Social Security
numbers, medical information, inappropriate language, or duplicate/near
duplicate examples of a mass-mail campaign. CDC will carefully consider
all comments submitted.
Background
On May 31, 2018, CDC requested public comment on a plan to (1)
revise the definition and characterization of Assisted Reproductive
Technology (ART) success rates and (2) introduce clinic validation
footnotes for the annual ART Fertility Clinic Success Rates Report (83
FR 25009). CDC received three public comments, of which one was non-
substantive, one was supportive of CDC's planned approach for revising
the definition of success rates and introducing clinic validation
footnotes without further suggestions, and one contained concerns about
CDC's planned clinic validation footnotes for identified major data
discrepancies and approach to clinic validation along with recommended
changes.
This comment expressed concern that random selection of clinics
during the current CDC validation system is unable to identify
systematic reporting errors. It was suggested that targeted selection
of clinics based on certain reporting characteristics that predict
erroneously inflated ART success rates is a better approach to identify
systematic reporting errors. There was also a concern that
discrepancies identified during on-site data validation are not
corrected prior to publication of the ART Fertility Clinic Success
Rates Report. It was suggested that instead of including a footnote,
identification of erroneous data should result in removing clinic
success rates from ART Fertility Clinic Success Rates Report, and that
erroneous data should not be included with data from other clinics.
Finally, there was a concern that validation footnotes and an appendix
will not be easily understood by the patients.
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 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 is another step
to ensure that clinics submit accurate data and to identify any
systematic problems that could cause data collection to be inconsistent
or incomplete.
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). CDC concurs with comments on
proposed changes to data validation procedures (83 FR 25009) that
targeted selection of clinics based on certain reporting
characteristics is another mechanism to identify systematic reporting
errors. CDC's current targeted selection practice includes revisiting a
small number of previously validated clinics to assess whether
previously identified reporting errors have been corrected. Effective
for calendar year 2022, CDC proposes to expand targeted selection 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 not be used in
[[Page 66567]]
calculating discrepancy rates since it cannot be generalizable for all
reporting clinics.
Since information on potential data errors is not available from
non-validated clinics and CDC's annual data validation only represents
a very small proportion of clinics (7-10%) and cycles (1% of total
reported cycles), correcting identified discrepancies in the final
dataset for a small subset of cycles will not have any significant
effect on data quality or published success rates. However, CDC took
into account comments that publishing inaccurate data with known major
discrepancies can be misleading, even in the presence of a footnote
describing data quality concerns. Therefore, if a clinic is selected to
participate in the NASS data validation process (either through
stratified random sampling or through targeted selection), does
participate, 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 helping, in part, to
ensure clinics submit accurate data and to identify any systematic
problems. 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 for data validation during the
following reporting year(s) to assess corrections of identified data
errors.
In addition, CDC will publish information 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 helping, in part, to
ensure clinics submit accurate data and to identify any systematic
problems. 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 for data validation 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 helping, in part, to
ensure clinics submit accurate data and to identify any systematic
problems. 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.
For 2017 reporting year, CDC started reporting cumulative success
rates which take into account successes over all embryo transfers
within 12-month period from a single oocyte retrieval and, therefore,
span two reporting years (83 FR 53253). Effective for data validation
conducted in calendar year 2021, data validation approach will be
aligned with ART reporting approach and will also span two reporting
years. Data validation conducted in 2021 will cover oocyte retrievals
conducted in reporting year 2018 and associated embryo transfers that
took place within 12-month period from oocyte retrievals (reporting
years 2018 and 2019). As a result of this transition to a cumulative
approach in data validation and due to impacts of the COVID-19 pandemic
(i.e., travel restrictions), no data validations will be conducted in
calendar year 2020.
Dated: October 15, 2020.
Sandra Cashman,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2020-23188 Filed 10-19-20; 8:45 am]
BILLING CODE 4163-18-P
