This chapter does not apply to the review of a fetal death that is the result of a voluntary or therapeutic termination of pregnancy. In this chapter, the following terms have the meanings indicated. Terms Defined. “Committee” means the Morbidity, Mortality, and Quality Review Committee established within the Department. “Department” means the Maryland Department of Health. “Jurisdiction” means a political subdivision of the State, including the 23 counties and Baltimore City. “Early childhood” means the period in which an individual is younger than 6 years old. “Fetal and infant mortality review (FIMR) team” means a local multidisciplinary and multiagency morbidity, mortality, and quality review team established by a health officer or health officers of a group of jurisdictions. “Fetal death” has the meaning stated in Health-General Article, §4-201, Annotated Code of Maryland. “Health care provider” has the meaning stated in Health-General Article, §5-601, Annotated Code of Maryland. “Health officer” has the meaning stated in Health-General Article, §1-101, Annotated Code of Maryland. “Infant death” means death occurring to an individual who is younger than 1 year old. “Maryland Perinatal System Standards” means the hospital perinatal program standards established by the Perinatal Clinical Advisory Committee of the Department. “Morbidity, mortality, and quality review (MMQR) team” means a local multidisciplinary and multiagency morbidity, mortality, and quality review team, or entity established to review cases associated with pregnancy, childbirth, infancy, or early childhood in order to make improvements in systems of care, including: A fetal and infant mortality review team; or Another multidisciplinary and multiagency review team or other entity established for a jurisdiction that addresses an aspect of morbidity, mortality, or quality of care associated with pregnancy, childbirth, infancy, or early childhood. “Perinatal center” means a hospital that offers obstetric or neonatal services, or both. “Secretary” means the Secretary of Health. “Transport” means the transfer of a patient to another health care facility. The Maryland Perinatal System Standards (Perinatal Clinical Advisory Committee, June 2014) is incorporated by reference. There is a Morbidity, Mortality, and Quality Review Committee established within the Department. The Committee shall be: A State-level multidisciplinary and multiagency review Committee within the Department; and Composed of at least 26 members as described in §§B and C of this regulation. Ex Officio Members. The Committee shall include the following ex officio members or their designees: The Secretary of the Maryland Department of Health; The Secretary of Human Services; The Deputy Secretary of the Health Care Financing Administration; The Director of the Vital Statistics Administration; The Director of the Prevention and Health Promotion Administration; The Director of the Behavioral Health Administration; The Director of the Maternal and Child Health Bureau; The Chief Medical Examiner; The Director of the Office of Minority Health and Health Disparities; The Director of the Office of Health Care Quality; The Executive Director of the Maryland Health Care Commission; The Executive Director of the Maryland Institute for Emergency Medical Services Systems; The Executive Director of the Medical and Chirurgical Faculty of Maryland; The President of the Maryland Hospital Association; The President of the Maryland Chapter of the American Academy of Pediatrics; The Chair of the Maryland Section of the American College of Obstetricians and Gynecologists; One representative from the University of Maryland School of Medicine; One representative from the Johns Hopkins School of Medicine; Three representatives from the Maryland Association of County Health Officers; The Chair of the Maryland State Child Fatality Review Team; and The Chair of the Maryland Maternal Mortality Review Committee. Appointed Members. The Secretary shall appoint one Committee member that is a certified nurse midwife from a list of qualified individuals submitted by professional nursing organizations that represent licensed registered nurses in Maryland. The Secretary may appoint up to five other Committee members and may appoint additional members who are individuals with an interest and expertise in pregnancy, childbirth, infancy, or early childhood or other related disciplines as considered necessary by the Secretary to carry out the Committee’s responsibilities. Appointed Committee members shall serve at the pleasure of the Secretary. Designation of Representatives. An ex officio member described under §B of this regulation may designate another individual to represent the member on the Committee from the member’s: Agency; Department; Office; or Organization. Invitees. The Secretary may invite representatives from other agencies and organizations, and individuals involved in the prevention or reduction of morbidity or mortality associated with pregnancy, childbirth, infancy, or early childhood, to attend a Committee meeting if the representative has information that may be necessary to inform the Committee. Term of Appointment. Appointed members shall serve for a term of 3 years. Staffing. The Committee may employ staff in accordance with the State budget. Expenses. Members of the Committee shall serve without compensation, but may be reimbursed for reasonable expenses incurred in the performance of their duties: In accordance with the standard State travel regulations; and As provided in the State budget. Chairperson. The Secretary or the Secretary's designee shall serve as Chairperson of the Committee. To achieve its purpose, the Committee shall: Provide consultation to FIMR teams and other MMQR teams; Conduct confidential and anonymous case reviews of morbidity and mortality associated with pregnancy, childbirth, infancy, and early childhood; Undertake annual statistical analysis of the incidence and cause of morbidity and mortality related to pregnancy, childbirth, infancy, and early childhood; Monitor hospital compliance with the Maryland Perinatal System Standards by: Reviewing documents requested of the hospital in writing or by conducting on-site reviews, or by both; and Making recommendations to improve or facilitate compliance; and Determine factors contributing to morbidity and mortality, and make recommendations for strategies to prevent and reduce morbidity and mortality related to pregnancy, childbirth, infancy, and early childhood throughout the State, including recommendations for changes to law, policy, or practice to prevent and reduce morbidity and mortality and improve the system of care. The Committee may: Evaluate the continued effectiveness and efficiency of the Statewide morbidity, mortality, and quality review process associated with pregnancy, childbirth, infancy, and early childhood and make or recommend appropriate changes as necessary; Establish special panels or ad hoc subcommittees of the Committee as necessary to carry out the duties of the Committee; Analyze data and review reports or other information from: FIMR teams; Other MMQR teams; or Other entities which are established for the purpose of addressing an aspect of morbidity, mortality, or quality reviews associated with pregnancy, childbirth, infancy, or early childhood; Develop protocols for data collection regarding morbidity and mortality related to pregnancy, childbirth, infancy, and early childhood; Examine the policies and procedures of State and local agencies, hospitals, and other entities that participate in the system of care; Review specific cases regarding pregnancy, childbirth, infancy, or early childhood that the Committee considers necessary to perform its duties; and Coordinate its activities with other State agencies in order to avoid unnecessary duplication of effort. A jurisdiction shall have a multidisciplinary and multiagency FIMR team or other MMQR team. The purpose of a FIMR team is to facilitate the reduction of fetal and infant deaths by: Conducting confidential case reviews of fetal and infant deaths including the examination of available medical and healthcare information involving fetal and infant mortality; and Based on the findings of the case reviews conducted under §B(1) of this regulation: Determining factors contributing to fetal and infant deaths; Developing recommendations to reduce factors contributing to fetal and infant deaths; Recommending strategies to improve the system of care in an effort to prevent or reduce fetal and infant deaths; and Informing the Committee of changes that affect fetal and infant deaths in: Local law; Policy; or Practices. A FIMR team shall: Analyze fetal and infant deaths to determine contributing system factors; and Make recommendations for systems change as appropriate. A FIMR team may: Evaluate the continued effectiveness and efficiency of the local fetal and infant mortality review process and make appropriate changes; and Establish protocols in compliance with State statutes and regulations, as applicable, for: Data collection; Analysis; and Reporting. Members of a FIMR team shall be appointed by the local health officer of the jurisdiction or be jointly appointed by the health officers of the jurisdictions comprising the multi-jurisdiction local team. A FIMR team shall appoint a chairman from among its membership. A FIMR team shall be multidisciplinary and include professionals and representatives of agencies that provide services or community resources for families in the community and community representatives. A FIMR team shall include at least one representative from: Public health programs, such as: Maternal and child health; Substance abuse; or Mental health; Health care provider specialties, such as: Obstetrics; Pediatrics; Social work; Nursing; or Nurse midwifery; and Hospitals, such as hospital administrators, or professionals with expertise in perinatal services or quality improvement. A FIMR team may include representatives from other agencies or community organizations involved with the prevention or reduction of fetal and infant deaths. MMQR teams may: Inform the Committee of changes that affect morbidity or mortality associated with pregnancy, childbirth, infancy, or early childhood in: Local law; Policy; or Practice; and Provide the Committee with requested reports and other information so that the Committee may perform its duties. The Committee may conduct morbidity, mortality, and quality reviews associated with pregnancy, childbirth, infancy, and early childhood, including but not limited to reviews of the following: Individual cases or clusters of cases of morbidity or mortality; Maternal or neonatal transport to or from perinatal centers; and Aggregate or hospital-specific cases of mortality or morbidity associated with pregnancy, childbirth, infancy, or early childhood. A health care provider, hospital, HIPAA (Health Insurance Portability and Accountability Act of 1996) business associate, or other related entity shall, on written request of the Committee, FIMR team, other MMQR team, or their staff, provide access to records concerning: Prepregnancy, prenatal, and postpartum care of the mother; Somatic, dental, and behavioral health of the mother; The health care provided by: A health care provider; A health care facility; or Emergency medical services; Emergency medical services system data on maternal and neonatal transport; State vital records data related to morbidity or mortality associated with pregnancy, childbirth, infancy, or early childhood; and Documentation relevant to the purpose and duties of the Committee, FIMR team, or other MMQR team that is maintained by a State or local government agency, including: Medical examiner investigative information; and Law enforcement investigative information, including police reports. The Committee, FIMR team, or other MMQR team shall assign staff to abstract information from patient medical records and other sources of information to which the Committee, FIMR teams, or other MMQR teams are entitled under §A of this regulation. Information abstracted under §B of this regulation shall be de-identified by the abstractor to remove information that would permit the identification of an individual health care recipient before the information may be used to carry out the purpose and duties of the Committee, FIMR team, or other MMQR team. The Committee shall meet at least semiannually. FIMR teams shall meet at least quarterly. A meeting of the Committee, FIMR teams, or other MMQR teams shall be closed to the public and is not subject to General Provisions Article, Title 3, Subtitle 3, Annotated Code of Maryland, when the Committee, local FIMR team, or other MMQR team is reviewing cases of pregnancy, childbirth, infancy, or early childhood. The Committee, FIMR team, or other MMQR team may invite an individual who is not a member to attend a Committee, FIMR team, or other MMQR team meeting if: The attendance is approved in advance by the Committee, FIMR team, or other MMQR team chairperson; Participation of the invited individual is intended to assist the Committee, FIMR team, or other MMQR team in carrying out its duties; and Invitees in attendance abide by the same confidentiality and nondisclosure requirements which govern the Committee, FIMR team, and other MMQR team members. The following shall be held confidential and may not be released to a person except as provided in this chapter: Records and information received by the Committee, FIMR team, or other MMQR team; Documents produced in the case review process; and Minutes of meetings of the Committee, FIMR team, or other MMQR team. Information and records obtained by the Committee, a FIMR team, or other MMQR team are exempt from disclosure under General Provisions Article, Title 4, Annotated Code of Maryland. The Committee, a FIMR team, or other MMQR team may not discuss, disclose, or use information for purposes other than as necessary to carry out the Committee’s, FIMR team’s, or other MMQR team’s duties and purposes under this chapter. Information that is disclosed to the public by the Committee, FIMR team, or other MMQR team shall be de-identified and may not contain information that would permit the identification of an individual, a health care provider, or a health care facility. The Committee, a FIMR team, or other MMQR team may release specific findings that relate to aggregate data as well as recommendations made by the Committee, FIMR team, or other MMQR team to prevent and reduce morbidity and mortality, and this information shall be public record. The Committee, FIMR team, other MMQR team, or their staff shall maintain the confidentiality of information used or addressed at meetings. A person in attendance at a meeting of the Committee, a FIMR team, or other MMQR team may not testify or be required to testify as to what transpired at that part of the meeting that is closed under General Provisions Article, Title 3, Subtitle 3, Annotated Code of Maryland. A member of the Committee, FIMR team, other MMQR team, their staff, or invitees may not be questioned in a civil or criminal proceeding regarding information presented at or opinions formed as a result of a closed Committee, FIMR team, or other MMQR team meeting. A member of the Committee, FIMR team, other MMQR team, their staff, or invitees, may testify in a civil or criminal proceeding to information that is: Obtained independent of the Committee, FIMR team, or other MMQR team; and Publicly available, except as otherwise provided by law. Information, documents, and records of the Committee, a FIMR team, or other MMQR team are not subject, in a civil or criminal proceeding, to: Subpoena; Discovery; or Introduction as evidence. Information, documents, and records obtained by the Committee, a FIMR team, or other MMQR team that are available from other sources may be subject, as provided by applicable law, to: Subpoena; Discovery; or Introduction into evidence. A person may not be held liable for civil damages or subject to a criminal or disciplinary action for good faith efforts made to comply with the provisions of this chapter. Health-General Article, §18-107, Annotated Code of Maryland Effective date: September 21, 2009 (36:19 Md R. 1436) Regulation .02B amended effective April 23, 2018 (45:8 Md. R. 421) Regulation .03 amended effective April 23, 2018 (45:8 Md. R. 421) Regulation .05 amended effective April 23, 2018 (45:8 Md. R. 421) Regulation .05B amended effective March 14, 2016 (43:5 Md. R. 385) Regulation .06 amended effective April 23, 2018 (45:8 Md. R. 421) Regulation .07 amended effective April 23, 2018 (45:8 Md. R. 421) Regulation .08 amended effective April 23, 2018 (45:8 Md. R. 421) Regulation .09 amended effective April 23, 2018 (45:8 Md. R. 421) Regulation .10 amended effective April 23, 2018 (45:8 Md. R. 421) Regulation .11 amended effective April 23, 2018 (45:8 Md. R. 421) Regulation .12 amended effective April 23, 2018 (45:8 Md. R. 421) Regulation .13 amended effective April 23, 2018 (45:8 Md. R. 421)