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[NCCDPHP] Maternal Mortality Review Information Application (MMRIA)

OMB: 0920-1294

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Maternal Mortality Review Information Application (MMRIA)



Revision [OMB Control No. 0920-1294, Exp. 04/30/2023]


Supporting Statement

Part A


March 30, 2023








Contact Person:

David Goodman

Telephone: (770) 488-6553

Fax: 770-488-6391

E-mail: [email protected]

Division of Reproductive Health

National Center for Chronic Disease Prevention and Health Promotion

Centers for Disease Control and Prevention

Atlanta, Georgia





Contents


List of Attachments………………………………………………………………………………………………….3



Attachments


Attachment 1a. Section 301 of the Public Health Service Act (42 U.S.C. 241)

Attachment 1b. Preventing Maternal Deaths Act

Attachment 2. Data Flow Diagram

Attachment 3a. MMRIA Abstraction and Narrative Forms

Attachment 3b. Committee Decision MMRIA Forms

Attachment 4a. MMRIA 60-Day Federal Register Notice

Attachment 4b. Reponse to Public Comments on the the 60-Day Federal Register Notice

Attachment 5. Privacy Impact Assessment

Attachment 6. Memorandum of Understanding for Central Hosting of MMRIA

Attachment 7. MMRIA Request for Determination of Research Status

Attachment 8. List of changes to MMRIA Forms




Shape1

  • Goal of the project: The goal of the Maternal Mortality Review Information Application (MMRIA) is to establish a comprehensive and standardized data collection system for case abstraction from clinical and nonclinical sources, documenting Maternal Mortality Review Committees’ (MMRCs) decisions, and analyzing data.

  • Intended use of the resulting data: MMRIA provides a comprehensive source of information regarding the causes and circumstances of pregnancy-related deaths. This information is used to identify strategies for preventing future pregnancy-related deaths.

  • Methods to be used to collect the data: Data is abstracted from a variety of sources, including vital records, social and environmental profiles, autopsy reports, prenatal care records, emergency department records, hospitalization and outpatient records, medical office visits, medical transport records, mental health profiles, and informant interviews. Information from these sources is used to create case narratives for use during committee reviews and subsequent committee decisions about contributing factors and recommendations for prevention of future maternal deaths.

  • The subpopulation to be studied: The subpopulation of interest for MMRIA is persons who died during pregnancy or within one year of the end of pregnancy whose deaths are reviewed by MMRCs to determine pregnancy-relatedness.

  • How the data will be analyzed: Data is analyzed by jurisdictions and CDC to provide timely, accurate, and standardized information about deaths during pregnancy and the year after the end of pregnancy within jurisdictions, and across participating jurisdictions; facilitate an understanding of the drivers of maternal mortality and complications of pregnancy and associated disparities and implement data driven recommendations (e.g., evidence-based practices, screenings, patient education by providers).


  1. Justification

  1. Circumstances Making the Collection of Information Necessary


This Information Collection Request (ICR) is for a revision of a previous ICR (OMB #0920-1294, Expiration 4/30/2023) to continue implementation of the Maternal Mortality Review Information Application (MMRIA) for three more years. MMRIA is a standardized data system that allows Maternal Mortality Review Committees (MMRCs) across the U.S. to abstract relevant data (clinical and non-clinical) about identified pregnancy-associated deaths from a variety of sources, create case narratives to facilitate review of data, document committee decisions such as pregnancy-relatedness of the death, contributing factors, and recommendations for future prevention efforts. CDC is authorized to collect this information under the Public Health Service Act, Title 42, Section 301 (Attachment 1a) and the Preventing Maternal Deaths Act (Attachment 1b).


Deaths during pregnancy or in the year after the end of pregnancy is a tragedy for families and for society as a whole. Considerable racial disparities exist in the United States, with non-Hispanic Native Hawaiian and Other Pacific Islander, non-Hispanic American Indian/Alaska Native and non-Hispanic Black women more likely to die from pregnancy-related complications than women of other race-ethnicity classifications. However, findings from MMRCs indicate that 4 of 5 pregnancy-related deaths are preventable. Understanding the true burden of these deaths, as well as why they continue to occur, is essential in our efforts to improve pregnancy and postpartum care, reduce related morbidity and mortality, and eliminate associated disparities. This activity supports a standardized approach to collecting data and sharing information on pregnancy-related deaths to aid in that understanding.

This information collection aims to provide a better understanding of pregnancy-related deaths by using MMRIA to collect standardized data across multiple MMRCs. The intent of the system is to provide the most detailed and complete data in order to better identify contributing factors and preventability and thus develop recommendations for prevention. The system also allows for sharing of data across MMRCs for aggregate analyses and reporting.


Although MMRIA is available for voluntary use by any MMRC in the U.S., this extension of information collection is only applicable to the 39 funding recipients, representing 40 reporting jurisdictions (39 states and 1 U.S. Territory, who are part of the cooperative agreements CDC-RFA-DP19-1908 and CDC-RFA-DP22-2211), and the potential 13 new funding recipients eligible to be part of a new cooperative agreement (CDC-RFA-DP-23-0066). These funding recipients are required to compile a defined set of information about deaths that occurred during pregnancy and the year after the end of pregnancy into MMRIA. For the purposes of this ICR, a “respondent” represents a jurisdictional funding recipient (through direct or sub-award).

  1. Purpose and Use of Information Collection


Maternal Mortality Review is a process by which a multidisciplinary committee at the jurisdiction level identifies and reviews cases of maternal death within one year of pregnancy; a data flow diagram of the process is provided in Attachment 2. Members of MMRCs typically represent public health, obstetrics and gynecology, maternal-fetal medicine, nursing, midwifery, forensic pathology, mental health, and behavioral health. Members might also include social workers, patient advocates, and other relevant multidisciplinary partners. Through a partnership among the MMRC, the state vital records office, and epidemiologists, deaths among women of reproductive age are examined to determine if they occurred during pregnancy or within a year of the end of pregnancy (i.e., pregnancy-associated deaths). Through this process, potential cases of pregnancy-related deaths (i.e., maternal death from any cause related to or aggravated by pregnancy or its management) are then identified. Review committees access multiple sources of clinical and non-clinical information to understand the circumstances surrounding a maternal death as they develop recommendations for action to prevent similar deaths in the future. This multidisciplinary approach encourages collaboration with clinical and non-clinical partnerships to improve quality of care and address social determinants of health to reduce health inequities.


MMRIA is a standardized data system that MMRCs use to collect timely, accurate, and standardized information about deaths to women during pregnancy and the year after the end of pregnancy, including opportunities for prevention, within and across jurisdictions. Data will be abstracted and entered into MMRIA from various sources, including death certificates, autopsy reports, birth certificates, prenatal care records, emergency room visits records, hospitalization records, records for other medical office visits, medical transport records, social and environmental profiles, mental health profiles, and informant interviews. Case narratives are automatically populated from the abstracted data for committee review, and subsequent committee decisions are also documented in MMRIA


Key activities to be conducted as part of MMRCs’ use of MMRIA by awardees include:

  1. Comprehensively identifying pregnancy-associated deaths

    1. Identify deaths to women that occur during pregnancy or within a year of the end of pregnancy on a routine basis, no later than one year following the date of death

    2. At a minimum, use death certificates and death certificates linked to sentinel vital statistics data (i.e., birth certificates and fetal death certificates in the year preceding death) to identify pregnancy-associated deaths

  2. Completely abstract available data to support multidisciplinary review of each death

    1. Abstract and enter comprehensive information about all deaths potentially related to pregnancy into the MMRIA in preparation for committee review within two years (CDC-RFA-DP19-1908) or 18 months (CDC-RFA-DP22-2211 and CDC-RFA-DP-23-0066) of the date of death

    2. Review all deaths potentially related to pregnancy within two years of the date of death

    3. Document committee decisions about a reviewed death in MMRIA consistent with guidance documents provided at reviewtoaction.org

    4. Enter all information into MMRIA within 30 days of completing the review of a death

    5. Perform data quality assurance checks within 90 days of completing the review of a death to, at a minimum, ensure completeness

  3. Using data from reviewed deaths for action

    1. Analyze MMRIA data to provide information on burden, such as pregnancy-related mortality ratio, counts of underlying causes of death, and distribution of deaths (e.g., by age, race, rurality), and opportunities for prevention

    2. Disseminate information (e.g., reports, publications, presentations, briefs) from analyses at least once per year to internal and external audiences for informing practice and policy changes


In summary, the information collected as part of this effort will be used to provide timely, accurate, and standardized information about deaths to women during pregnancy and the year after the end of pregnancy within and across participating jurisdictions; facilitate an understanding of the drivers of maternal mortality and complications of pregnancy and associated disparities and implement data driven recommendations (e.g., evidence-based practices, screenings, patient education by providers).


In addition to the aforementioned uses, the information compiled in MMRIA can be used by CDC and participating jurisdictions to identify strategies to achieve and inform progress towards the Healthy People 2030 goals “MICH-04 Reduce maternal deaths” and “MICH-05: Reduce severe maternal complications identified during delivery hospitalizations.”


  1. Use of Improved Information Technology and Burden Reduction


MMRIA is a consolidated, standardized data management system that enables MMRCs to collect and analyze data regarding maternal deaths. The system facilitates the process of case review of pregnancy-associated deaths to determine pregnancy-relatedness.


In order to comprehensively review each case of maternal death, MMRCs must capture detailed medical and social information on each woman who dies during pregnancy or within one year of the end of pregnancy in their jurisdiction. MMRCs employ abstractors (typically, but not always, nurse practitioners) within their jurisdictions who collect the pertinent information for each case by accessing various sources of information. The jurisdiction-based abstractors then manually enter relevant case details into MMRIA (Attachment 3a). The system produces a semi-automated case narrative that abstractors can then print and present to committee members to read during MMRC meetings, which convene on a routine basis as decided by the committee (typically monthly or quarterly) (Attachment 3a). During or shortly after meetings, abstractors enter the committee’s findings on preventability, contributing factors, and recommendations for action into MMRIA (Attachment 3b).


MMRIA was created using lessons learned from a prototype system developed at CDC, MMRDS, which was implemented in 13 states starting in 2012. MMRDS was a simple system built on the CDC Epi-Info surveillance platform; DRH created MMRDS in response to states’ expressed desire for a common data system. Prior to MMRDS, each state used its own data system, ranging from Excel spreadsheets to Access databases to REDCap; states expressed that they did not have the resources to continuously update and support their own home-grown data systems. MMRDS met this need at that time.


Over several years of working closely with the early adopter states of MMRDS, it became clear that states wanted a more multi-faceted, flexible, and adaptable data system than what MMRDS provided. As part of the initiative Building U.S. Capacity to Review and Prevent Maternal Deaths, MMRIA was created and released in April 2017. Compared to MMRDS, MMRIA provided multiuser capability, ability to operate on web servers, more timely corrections to errors, and expansion of location-based information.


From April 2017 through February 2019, MMRIA was only available to jurisdictions to host on their own servers. This model of “local hosting” created a burden for MMRCs whose IT requirements could cause delays of 6 months to a year, delays in installing updates once available, and result in prohibitive budget costs to MMRCs for the associated IT installation and maintenance support. In addition, the variation in IT requirements and expertise of IT departments across jurisdictions resulted in extensive technical support from the CDC-based MMRIA team, taking time away from MMRIA development and technical assistance to MMRCs.


In April 2019, DRH began making MMRIA available to states as a service via a central CDC server. The transition to CDC hosting, which removes the jurisdiction-specific IT barriers and allows single roll out of MMRIA updates to users, eased the burden both on jurisdictions and the CDC-based MMRIA team. MMRIA has an approved Security Impact Analysis (SIA) Agreement to operate within Infrastructure Services Branch's (ISB), Enterprise Container Platform as a Service (ECPaaS) which is under the CDC’s Azure General Systems Support (GSS) System Authorization To Operate (ATO) that expires 11/2/2023.


In September 2019, DRH established a process that reduces burden related to abstraction of vital records into MMRIA. This process includes CDC staff downloading vital records and conducting centralized identification of pregnancy-associated deaths for jurisdictions providing data to the CDC through the State and Territorial Exchange of Vital Events (STEVE) system. Once case identification is complete, CDC uploads vital records data into MMRIA, eliminating the need for these jurisdictions to manually enter vital records information.1 Nineteen jurisdictions with current or possible CDC funding support in FY23 are currently participating in this process, while 34 are not currently participating.


  1. Efforts to Identify Duplication and Use of Similar Information

Two major surveillance systems—the National Vital Statistics System (NVSS) and the Pregnancy Mortality Surveillance System (PMSS)—have been used to provide measures of maternal mortality burden nationally.2


NVSS provides maternal death counts using death records submitted by states and publishes maternal mortality rates (deaths/100,000 live births) by applying the World Health Organization’s International Classification of Diseases codes to death certificates submitted by states. In this system, maternal deaths are defined temporally as deaths that occur during pregnancy or within 42 days of the end of pregnancy. The causality is defined as a death from any cause related to or aggravated by the pregnancy or its management but not from accidental or incidental causes. NVSS relies solely on ICD-10 codes from death records, which are readily available but limited in detail; death record data provides high-level national estimates of maternal deaths and trends over time, but do not enable an understanding of the circumstances of a death in regard to contributing factors and preventability.


In 1986, PMSS was developed to better understand the risk factors for and causes of pregnancy-related deaths in the U.S.; it introduced the following terms:

  • Pregnancy-associated death: umbrella term for all deaths during pregnancy or within one year of pregnancy, regardless of cause

  • Pregnancy-related death: the death of a woman while pregnant or within one year of pregnancy—regardless of the outcome, duration, or site of the pregnancy—from any cause related to or aggravated by the pregnancy or its management, but not from accidental or incidental causes

  • Pregnancy-associated but not related death: the death of a woman during pregnancy or within one year of the end of pregnancy from a cause that is not related to pregnancy

PMSS requests state Vital Records Offices voluntarily cast a broad net to identify potential pregnancy-associated deaths by using pregnancy checkbox information, cause of death information, and linkages of death records among females ages 10-60 years to birth and fetal death records. Medical epidemiologists review and analyze death records, linked birth records and fetal death records if applicable, and additional available data from all 50 states, New York City, and Washington, DC. Deaths are confirmed as pregnancy-related if they occur during pregnancy or within one year of pregnancy and the death results from: 1) complications of pregnancy itself; 2) a chain of events initiated by pregnancy; or 3) aggravation of an unrelated event by the physiologic effects of pregnancy. PMSS then produces a pregnancy-related mortality ratio (pregnancy-related deaths/100,000 live births). Although PMSS allows for an enhanced clinical interpretation that is not possible through NVSS, it remains limited to information primarily derived from death and birth records.


MMRCs do not solely rely on vital records and includes clinical and nonclinical information from a variety of sources that are needed to fully understand the causes and circumstances surrounding maternal deaths. MMRIA provides a standardized data collection system that MMRCs use to abstract data into from these diverse sources. MMRIA also allows MMRCs to develop and document case narratives from the abstracted data for use during committee review and to subsequently document committee decisions. This comprehensive, standardized data system facilitates sharing of information among jurisdictions and the development of strategies for maternal mortality prevention. MMRCs are the only comprehensive source of maternal mortality data, with MMRIA facilitating the MMRC review and data use.


Table 1. Comparison of Maternal Mortality Data Sources3


NVSSa

PMSSb

MMRCsc

Timeframe

During pregnancy or within 42 days end of pregnancy

During pregnancy or within 1 year of pregnancy

During pregnancy or within 1 year of pregnancy

Source

Death records

Death records, and death records linked birth or fetal death records, additional information as available

Death records, and death records linked birth or fetal death records, diverse clinical and non-clinical records (e.g., medical records, social service records, autopsy, informant interviews).

Measure

Deaths/100,000 live births

Pregnancy-related deaths/100,000 live births (national)

Pregnancy-related deaths/100,000 live births (jurisdiction)

Purpose

Provide maternal mortality rate at the national level

Analyze clinical factors associated with deaths, publish information that may lead to prevention strategies

Understand medical and non-medical contributors to deaths, inform prioritization of interventions that effectively reduce pregnancy-related deaths

aNational Vital Statistics System

bPregnancy Mortality Surveillance System

cMaternal Mortality Review Committees



  1. Impact on Small Businesses or Other Small Entities


There will be no impact on small business.


  1. Consequences of Collecting the Information Less Frequently

MMRCs aim to identify deaths among women that occur during pregnancy or within one year of the end of pregnancy on a routine basis--no later than one year following the date of death. MMRCs routinely abstract data to support multidisciplinary review of each death by abstracting and entering comprehensive information about all deaths potentially related to pregnancy into MMRIA in preparation for committee review. MMRCs convene on a routine basis as decided by the committee (typically monthly or quarterly). The consequences of collecting the information less frequently are the limited ability for timely assessment of the pregnancy-relatedness of deaths during and up to one year after pregnancy, the drivers of pregnancy-related deaths and to develop recommendations to prevent future pregnancy-related deaths. Data will be used to inform maternal health programs and policy to reduce maternal mortality.


  1. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5


There are no special circumstances. This request complies with the regulation of 5 CFR 1320.5.


  1. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency


A 60-day notice was published in the Federal Register on January 11, 2023, Vol. 88, No. 7, pp. 1580-1582 with the title “The Maternal Mortality Review Information Application (MMRIA)” (Attachment 4a). CDC received one comment related to this notice and was supportive (Attachment 4c). CDC has provided a response to the comment (Attachment 4b). No changes to the data collection have been made in response to this comment.


A number of representatives from MMRCs and partners were consulted on identifying the initial content of MMRIA and its precursor MMRDS. Since identification of the initial content, additional changes to the content have occurred based on informal user feedback.

Maternal Mortality Review Committees (MMRC) Initially Consulted (2013-14)

MMRC

California

Michigan

Colorado

New Jersey

Delaware

New York (State)

Florida

Ohio

Georgia

Philadelphia

Iowa

Utah

Louisiana

Virginia

Massachusetts

Wisconsin

Additional Maternal Mortality Review Committees (MMRC) Consulted (2015 to present)

MMRC

Hawaii

North Carolina

Illinois

Oklahoma

Maryland

South Carolina

Mississippi

Tennessee

New Mexico

Texas

New York City

Washington (State)

Additional Partner Organizations Consulted (2013-present)

Name/Organization

Subject Matter Expertise Provided

American College of Obstetricians and Gynecologists

Obstetric care

Association of Maternal and Child Health Programs

Title V Maternal and Child Health Block Grants and associated programs in states

CDC, Division of Reproductive Health

Maternal Mortality Measurement and Surveillance

CDC, Center for Global Health

Maternal Mortality Measurement and Surveillance

CDC, Center for Surveillance, Epidemiology, and Laboratory Services

EpiInfo 7

Society for Maternal and Fetal Medicine

High risk obstetric care

Emory University Rollins School of Public Health

Community Vital Signs Indicators and dashboards

CDC Foundation MMRIA Racism and Discrimination Workgroup

Fields for documenting discrimination and racism in MMRIA












  1. Explanation of any Payment/Gift to Respondents


Not applicable.

  1. Protection of the Privacy and Confidentiality of Information Provided by Respondents


Privacy Act Determination

A Privacy Impact Assessment has been completed for the MMRIA platform (Attachment 5). CDC’s Privacy Officer has advised that the Privacy Act does not apply to deceased individuals. However, a System of Records Notice (SORN) does apply because PII is stored, and the information is retrieved by a personal identifier; and this requirement is not altered by the death of the person whose identifiers are stored. The System of Records Notice (SORN) being used is 09-20-0166 (Federal Register document citation: 49 FR 37695).


Overview of the Data Collection System

MMRIA is a standardized data system that collects timely, accurate, and standardized information (clinical and non-clinical) about deaths to women during pregnancy and within one year of the end of pregnancy within and across jurisdictions. MMRIA can also be used to create case narratives, document committee decisions, and analyze data. The data gathered, reviewed, and analyzed by MMRCs will provide a better understanding of the contributors of maternal deaths, and thus inform efforts to prevent future maternal deaths.


Jurisdiction-level datasets for each MMRC are owned by individual jurisdictions and are used for purposes at the discretion of the jurisdiction. Each jurisdiction is assigned a separate URL. Users only have access to their own URL. Each awardee can only view data they have entered into MMRIA. As part of central hosting, users of MMRIA will have a Memorandum of Understanding with CDC governing the terms of utilizing MMRIA for their jurisdiction (Attachment 6).


Items of Information to be Collected

Data entered into MMRIA pertaining to maternal death may include data abstracted from death certificates, autopsy reports, birth certificates, prenatal care records, emergency room visits records, hospitalization records, records for other medical office visits, medical transport records, social and environmental profiles, mental health profiles, and informant interviews (Attachment 3a). Case narratives are auto-populated from the abstracted data to facilitate committee review (Attachment 3a). MMRCs will review the case narratives developed from MMRIA to understand the circumstances around and preventability of the deaths; committee decisions and findings will be entered in MMRIA (Attachment 3b). Each case record may contain up to 1000 data elements. A full list of all data elements collected is currently available at https://demo-mmria.cdc.gov/data-dictionary. Approximately 30 fields are available to be completed, as is relevant, after the committee review of each death.


How Information Will Be Shared and For What Purpose

The information collected in MMRIA will ultimately be used to provide timely, accurate, and standardized information about deaths to women during pregnancy and within one year of the end of pregnancy within and across participating jurisdictions; facilitate an understanding of the drivers of maternal mortality and complications of pregnancy and associated disparities; and implement data driven recommendations (e.g., evidence-based practices, screenings, patient education by providers). In conjunction with states, CDC will perform quality checks to clean and edit data, as well as and analyze data to better understand the contributors of maternal deaths (aggregate analyses will be performed with MMRC data from states that give permission to do so). At a minimum, an annual data brief will be published. Topical reports and publications will also be routinely published to address emerging issues and to provide more in-depth analysis of select topics. In September 2022 the first aggregate analysis since ERASE MM was established using data from MMRIA (Pregnancy-Related Deaths: Data from Maternal Mortality Review Committees in 36 US States, 2017–2019 | CDC).


MMRCs may share raw data and/or summary data with each other at their discretion. There will be no MMRIA public use dataset.


Impact of the Proposed Collection on Respondents’ Privacy

Personally identifiable information (PII) can only be viewed and edited by a limited set of users assigned the Abstractor user role within each jurisdiction. PII in MMRIA is necessary for abstractors to produce a de-identified case narrative of events preceding each woman's death, which is then provided to committee members who review each case. Abstractors must be able to identify individual records by name in order to locate records and enter data accurately. Abstractors remove all PII before presenting a case to the committee. No PII is shared from MMRIA to any external systems without written approval from the awardee or unless required by applicable law.


MMRIA employs role-based access to ensure the concept of "Least Privilege" is implemented and only those who need access will have access. There are 4 MMRIA roles in use within each awardee’s MMRIA instance: Jurisdiction Administrator, Abstractor, Analyst, and Committee Member.

  • Jurisdiction Administrator: has read/write access to users and jurisdiction. Activity Administrator is responsible for creating, maintaining, and deleting user accounts for Abstractors and Committee Members in their jurisdiction. Note: this is a separate role from the Secure Access Management Services (SAMS) Activity Administrator; however, one person can have both SAMS Activity Administrator and MMRIA Jurisdiction Administrator roles.

  • Abstractor: has read/write access to the case database for cases within their assigned jurisdiction. An Abstractor has access to PII.

  • Analyst: has read access to the case database for cases within their assigned jurisdiction. An Analyst has access to PII.

  • Committee Member: has read access to a de-identified case database for cases within their assigned jurisdiction. The de-identified case database contains no PII.

MMRIA data is not accessible to CDC staff for analysis purposes unless the jurisdiction specifically grants approval in writing. Some software support situations will require access to a jurisdiction’s data. CDC has identified only a few individuals who may need to access MMRIA data for software support; access is limited to those individuals.


MMRIA is covered by an Assurance of Confidentiality (Section 308[d] of the Public Health Service Act), which is approved through 7/31/2027.


Opportunities to Consent

Because the data abstracted pertains to deceased individuals, informed consent is not applicable.


How Information Will Be Secured

MMRIA is hosted on a CDC Cloud Services solution. As a cloud service, it is subject to full security assessment, authorization, and continuous monitoring under the Federal Risk and Authorization Management Program (FedRAMP). MMRIA will be secured for confidentiality and integrity at a moderate level based on the requirements of the Federal Information Security Management Act (FISMA).


MMRIA data is protected from unauthorized access, use, disclosure, duplication, modification, diversion, or destruction—whether accidental or intentional—in order to maintain confidentiality, integrity, and availability. The security and privacy controls that provide this protection meet minimum federal requirements with additional risk-based and business-driven control implementation achieved through a defense-in-depth security structure.


Data is encrypted in transit and at rest following the National Institute of Standards and Technology’s Federal Information Processing Standard (FIPS 140-2) for Security Requirements for Cryptographic Modules. FIPS 140-2 specifies the security requirements that will be satisfied by a cryptographic module 2 are accepted by the Federal agencies for the protection of sensitive information.


Per FedRAMP requirements, MMRIA employs more than 300 security controls. More information on the required FedRAMP security controls for systems deemed moderate can be found at https://www.fedramp.gov/understanding-baselines-and-impact-levels/.


  1. Institutional Review Board (IRB) and Justification for Sensitive Questions


IRB approval was not required as this project was determined to be public health practice (Attachment 7). The purpose of this surveillance system is to prevent maternal mortality in a defined population by producing information about the population from whom the data were collected.


Some information surrounding the circumstances of maternal death entered into MMRIA may be considered sensitive; such information may include topics of medical conditions, mental health profiles, and autopsy report findings. However, all of this information is necessary to facilitate an understanding of the drivers of maternal mortality and to thus determine opportunities to prevent future maternal deaths.


These deaths are usually highly visible in the community and often the subject of litigation. Therefore, release of information from MMRIA could be used in some way, directly or indirectly, to identify individuals and institutions is a very sensitive concern for the privacy of the families and the protection of the health care providers.  In cases where the pregnancy outcome for a woman who dies is a live birth, a linked live birth certificate is also collected; therefore, the assurance of confidentiality is also needed to protect the identity of the living child. The identification of women whose deaths are related to abortion is of even greater concern.  If the identity of individual women or their physicians is made known or if the identity of institutions where abortions are performed is known, harassment, intimidation, and even harm can occur. To securely protect the information collected, MMRIA is covered by an Assurance of Confidentiality (Section 308[d] of the Public Health Service Act), which is approved through 7/31/2027.

  1. Estimates of Annualized Burden Hours and Costs


Burden estimates presented here are for 39 funding recipients, representing 40 jurisdictions, of CDC-RFA-DP19-1908 and CDC-RFA-DP22-2211, and 13 jurisdictions that are eligible to apply to receive funding through a new cooperative agreement (CDC-RFA-DP-23-0066). As part of these cooperative agreements, these jurisdictions are required to compile a defined set of information about deaths that occur during pregnancy or the year after the end of pregnancy into MMRIA. The funded jurisdiction is considered the respondent.


Estimates of the anticipated number of pregnancy-associated deaths each year (based on a 3-year average) were derived for 40 jurisdictions (39 receive funding through CDC-RFA-DP19-1908 and CDC-RFA-DP22-2211, but one funding recipient provides a subaward to an additional respondent) and for remaining 13 eligible jurisdictions that may apply to receive funding in FY23 (CDC-RFA-DP-23-0066). Data were derived primarily from the Pregnancy Mortality Surveillance System (PMSS; 2017-2019)4. PMSS estimates of pregnancy-associated deaths each year are higher compared to CDC WONDER (the data source that was used previously), as identification of pregnancy-associated deaths is more comprehensive and complete due to utilization of multiple methods by PMSS to identify deaths. Alternative data sources were used to derive estimates of pregnancy-associated deaths for 2 jurisdictions not currently represented in PMSS. Estimates (2017-2019) for one jurisdiction not represented in PMSS were derived from their application materials from CDC-RFA-DP22-2211, which included annual counts of pregnancy-associated deaths they identified through use of their vital records data. Estimates (2014-2016) for an additional jurisdiction not represented in PMSS were derived from their application materials from CDC-RFA- DP19-1908. This jurisdiction was not funded from CDC-RFA- DP19-1908, but eligible to apply to CDC-RFA-DP-23-0066, so included in burden estimates. From this approach, we estimate on average an annual total of 2,240 pregnancy-associated deaths. Annually, this equates to an average 42 responses for each of the 53 jurisdictions per year. The increase from 30 to 42 responses on average per year due to shifting from CDC WONDER to PMSS for estimating the anticipated number of pregnancy-associated deaths.


Burden is assessed for each jurisdiction’s total staff time to abstract and enter abstracted data into MMRIA (case narratives are autocompleted and not included in burden hours) as well as enter the committee decision after review. It is estimated that on average, 15 hours of abstraction are required for each death entered into MMRIA. CDC has established a process that reduces the burden related to abstraction of vital records into MMRIA that is currently applicable to 19 funding recipients. This process includes CDC staff downloading vital records and conducting centralized identification of pregnancy-associated deaths for jurisdictions providing data to CDC through the State and Territorial Exchange of Vital Events (STEVE). Once case identification is complete, CDC uploads vital records data into MMRIA, eliminating the need for these jurisdictions to manually enter vital records information.5 For these jurisdictions the estimated average is 14 hours of abstraction for each death entered into MMRIA. For all jurisdictions, an additional 24 minutes on average is needed to enter the committee decisions —we estimate an average total annual burden of 33,482 hours (Table 2).













Table 2. Estimated Annualized Burden to Respondents


Types of Respondents

Form Name

Number of Respondents

Number of Responses per

Respondent

Average hours per response (in hours)

Total Burden

Hours


Jurisdictions with current or potential funding support through CDC-RFA-DP19-1908, CDC-RFA-DP22-2211, and CDC-RFA-DP-23-0066 who manually abstract all data into MMRIA

MMRIA abstraction form

34

42

15

21,420

Jurisdictions with current or potential funding support through CDC-RFA-DP19-1908, CDC-RFA-DP22-2211, and CDC-RFA-DP-23-0066 for which CDC is uploading vital records into MMRIA and jurisdiction staff abstract remaining data manually into MMRIA

MMRIA abstraction form

19

42

14

11,172

All jurisdictions with current or potential funding support through CDC-RFA-DP19-1908, CDC-RFA-DP22-2211, and CDC-RFA-DP-23-0066

MMRIA committee decision form

53

42

24/60

890

Total

33,482

Given that most, but not all, case abstractors are nurse practitioners, the estimates of hourly wages for Nurse Practitioner abstractors were obtained from the Department of Labor, Bureau of Labor Statistics.6 The Median hourly wage for Nurse Practitioner is $58.02. The total estimated annualized cost to respondents is $1,942,625 (Table 3).

Table 3. Estimated Annualized Cost to Respondents

Type of Respondents

Form Name

No. of Respondents

Total Burden

(in hrs.)

Average Hourly Wage Rate

Total Cost Burden

Jurisdictions with current or potential funding support through CDC-RFA-DP19-1908, CDC-RFA-DP22-2211, and CDC-RFA-DP-23-0066 who manually abstract all data into MMRIA

MMRIA abstraction form

34

21,420

$58.02

$1,242,788

Jurisdictions with current or potential funding support through CDC-RFA-DP19-1908, CDC-RFA-DP22-2211, and CDC-RFA-DP-23-0066 for which CDC is uploading vital records into MMRIA and jurisdiction staff abstract remaining data manually into MMRIA

MMRIA abstraction form

19

11,172

$58.02

$648,199

All jurisdictions with current or potential funding support through CDC-RFA-DP19-1908, CDC-RFA-DP22-2211, and CDC-RFA-DP-23-0066

MMRIA committee decision form

53

890

$58.02

$51,638

Total

$1,942,625





  1. Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers


There are no maintenance or capital costs to respondents.


  1. Annualized Cost to Federal Government


The total annual cost to the government is $19,757,689; it is based on funding to awardees through CDC-RFA-DP19-1908, CDC-RFA-DP22-2211, CDC-RFA-DP23-0066, and CDC personnel and time (Table A.14).


Table A.14. Annualized Cost to the Federal Government

Expense Type

Expense Explanation

Annual Costs (dollars)

Cooperative Agreement

Cooperative Agreement DP19-1908 with 25 Maternal Mortality Review Committee Awardees

$11,170,723


Cooperative Agreement

Cooperative Agreement DP22-2211 with 15 Maternal Mortality Review Committee Awardees

$2,805,149

Cooperative Agreement

Cooperative Agreement DP23-0066 with 13 Maternal Mortality Review Committee eligible to apply

$4,125,000

CDC Personnel

Information Technology Manager GS-14, 100% of FTE

$148,812

Epidemiologist GS-14, 60%

$80,030

Epidemiologist GS-13, 80%

$100,922

Public Health Advisor GS-13, 60%

$67,725

Public Health Advisor GS-13, 100%

$112,874

Public Health Advisor GS-12/13, 100%

$102,915

Public Health Advisor GS-13, 100%

$112,874

Public Health Advisor GS-13, 100%

$112,874

Public Health Advisor GS-13, 100%

$102,915

Public Health Advisor GS-13, 100%

$112,874

Public Health Advisor GS-13, 100%

$102,915

Public Health Advisor GS-13, 50%

$59,757

Public Health Advisor GS-13, 100%

$122,832

Public Health Advisor GS-14, 100%

$133,383

Medical Officer GS-14, 50%

$112,500

Team Lead, GS-14, 50%

$70,615

Subtotal, CDC Personnel

$1,656,817


TOTAL COST TO THE GOVERNMENT

$19,757,689



  1. Explanation for Program Changes or Adjustments


This request is for a revision. CDC is seeking a revision due to 1) an increase in the number of funding recipients that are required to use the MMRIA system, 2) an increase in the estimated number of pregnancy-associated deaths for which data is abstracted per jurisdiction, 3) application of processes that reduce the per case burden for some jurisdictions, and 4) changes to fields to the MMRIA abstraction form. The first three changes each impact the burden resulting in an overall increase to the estimated burden from 11,550 (last approval) to 33,482 for a total increase of 21,932 hours.



  1. Increase in funding recipients. Through additional congressional appropriations, an additional 15 jurisdictions are now funding recipients from the time of initial OMB PRA approval. This represents an increase from 25 (one funding recipient provides a subaward to an additional respondent) to 39 reporting jurisdictions. In addition, there are a potential 13 new funding recipients that may apply in in FY23. There is a total of 53 respondents accounted for in the burden hours.



  1. Increase in estimate of pregnancy-associated deaths. CDC estimates a higher number of pregnancy-associated deaths due to utilizing PMSS for these estimates, rather than CDC WONDER which was used for previous estimates. PMSS estimates of pregnancy-associated deaths are more accurate due to more comprehensive and complete identification of these deaths through multiple case identification methods. The shift to PMSS increased the average expected number of responses per respondent from 30 to 42.



  1. Implementation of processes to decrease respondent burden. CDC has been working with the National Association for Public Health Statistics and Information Systems on an initiative that enables CDC to transfer vital records data associated with CDC identified pregnancy-associated deaths directly into a jurisdiction’s instance of MMRIA, reducing manual data entry burden for the 19 respondents participating in the initiative. This reduced the per case burden from 15 to 14 hours of data abstraction for participating jurisdictions.



  1. Added fields to the MMRIA abstraction form to address user identified needs and increase data use for analysis by jurisdictions. A total of 60 new optional fields were added, 3 fields removed, and two fields combined into 1. A summary of changes is provided in Attachment 8. None of the added fields are required fields; 50 would only be relevant for specific causes of death or only when a specific type of record is available; the majority of new optional fields are drop down fields with minimal response burden. This change is not expected to change the average hours per response for completing the MMRIA abstraction form.


  1. Plans for Tabulation and Publication and Project Time Schedule


MMRIA data collection is ongoing. Data is submitted bi-annually to CDC for editing and cleaning. Data quality reports will be generated and returned to each state within 3 months of receiving data. Editing, cleaning, and analysis of the data will be conducted by CDC on an ongoing basis. There will be no MMRIA public use dataset. Aggregate analyses will be performed with MMRC data from states that give permission to do so. At a minimum, an annual data brief will be published. Topical reports and publications will also be routinely published to address emerging issues, and to provide more in-depth analysis of select topics.


Table A.16-1. Anticipated Project Time Schedule for Reporting Jurisdictions

Task

Timeframe

Data abstraction begins

Ongoing

Case narrative developed

Within the 14 days prior to committee review

Committee review

Within 3 months from completing data abstraction

Committee decision documented

Within 30 days of committee review

Data quality assurance

Quarterly

Data submitted to CDC for editing/cleaning

Bi-annually

Data returned to awardees

Within 3 months of CDC receipt

Analysis of aggregate data

At least annually

Reports/publications

At least annually


  1. Reason(s) Display of OMB Expiration Date is Inappropriate

Not applicable. The expiration date of OMB approval will be displayed.


  1. Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification.



1 Trost SL, Beauregard J, Petersen EE, et al. Identifying Deaths During and After Pregnancy: New Approaches to a Perennial Challenge. Public Health Reports. 2022;0(0). doi:10.1177/00333549221110487

2 St. Pierre A, Zaharatos J, Goodman D, Callaghan WM. Challenges and Opportunities in Identifying, Reviewing, and Preventing Maternal Deaths. Obstet Gynecol 2018;131:138-42.

3 Adapted from: St. Pierre A, Zaharatos J, Goodman D, Callaghan WM. Challenges and Opportunities in Identifying, Reviewing, and Preventing Maternal Deaths. Obstet Gynecol 2018;131:138-42.

5 Trost SL, Beauregard J, Petersen EE, et al. Identifying Deaths During and After Pregnancy: New Approaches to a Perennial Challenge. Public Health Reports. 2022;0(0). doi:10.1177/00333549221110487

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