PROPOSAL
Issue Date: January 19, 2018
Volume 45 • Issue 2 • Pages 86—89
Title 10
MARYLAND DEPARTMENT OF HEALTH
Subtitle 11 MATERNAL AND CHILD HEALTH
10.11.06 Morbidity, Mortality, and Quality Review Committee — Pregnancy and Childhood
Authority: Health-General Article, §18-107, Annotated Code of Maryland
Notice of Proposed Action
[18-012-P-I]
The Secretary of Health proposes to amend Regulations .02, .03, and .05—.13 under COMAR 10.11.06 Morbidity, Mortality, and Quality Review Committee — Pregnancy and Childhood.
Statement of Purpose
The purpose of this action is to:
(1) Update the incorporation by reference for the Maryland Perinatal System Standards to the most recent revision;
(2) Update the membership of the Morbidity, Mortality, and Quality Review Committee;
(3) Edit language describing the duties and role of the Morbidity, Mortality, and Quality Review Committee; and
(4) Make other minor updates to modernize language.
Comparison to Federal Standards
There is no corresponding federal standard to this proposed action.
Estimate of Economic Impact
The proposed action has no economic impact.
Economic Impact on Small Businesses
The proposed action has minimal or no economic impact on small businesses.
Impact on Individuals with Disabilities
The proposed action has no impact on individuals with disabilities.
Opportunity for Public Comment
Comments may be sent to Michele Phinney, Director, Office of Regulation and Policy Coordination, Maryland Department of Health, 201 West Preston Street, Room 512, Baltimore, MD 21201, or call 410-767-6499 (TTY 800-735-2258), or email to mdh.regs@maryland.gov, or fax to 410-767-6483. Comments will be accepted through February 20, 2018. A public hearing has not been scheduled.
Editor’s Note on Incorporation by Reference
Pursuant to State Government Article, §7-207, Annotated Code of Maryland, the Maryland Perinatal System Standards (Perinatal Clinical Advisory Committee, June 2014) has been declared a document generally available to the public and appropriate for incorporation by reference. For this reason, it will not be printed in the Maryland Register or the Code of Maryland Regulations (COMAR). Copies of this document are filed in special public depositories located throughout the State. A list of these depositories was published in 45:1 Md. R. 8 (January 5, 2018), and is available online at www.dsd.state.md.us. The document may also be inspected at the office of the Division of State Documents, 16 Francis Street, Annapolis, Maryland 21401.
.02 Definitions.
A. (text unchanged)
B. Terms Defined.
(1)—(4) (text unchanged)
(5) “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.
[(5)] (6)—[(8)] (9) (text unchanged)
[(9) “Local fetal and infant mortality review (FIMR) team” means a multidisciplinary and multiagency morbidity, mortality, and quality review team established by a health officer or health officers of a group of jurisdictions.
(10) “Local morbidity, mortality, and quality review (MMQR) team” means any local multidisciplinary and multiagency morbidity, mortality, and quality review team, or entity established to review cases associated with pregnancy, childbirth, infancy, and early childhood in order to make improvements in systems of care, including:
(a) A local fetal and infant mortality review team; and
(b) Any other local multidisciplinary and multiagency review team or other entity established for a jurisdiction that addresses any aspect of morbidity, mortality, and quality of care associated with pregnancy, childbirth, infancy, and early childhood.]
[(11)] (10) (text unchanged)
(11) “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) A fetal and infant mortality review team; or
(b) 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.
(12) “Perinatal center” means a hospital that offers obstetric or neonatal services, or both.
(13) “Secretary” means the Secretary of Health [and Mental Hygiene].
(14) (text unchanged)
.03 Incorporation by Reference.
The Maryland Perinatal System Standards ([Maryland Department of Health and Mental Hygiene,] Perinatal Clinical Advisory Committee, [October 2008] June 2014) is incorporated by reference.
.05 Membership.
A. The Committee shall be:
(1) (text unchanged)
(2) Composed of at least [25] 26 members as described in §§B and C of this regulation.
B. Ex Officio Members. The Committee shall include the following ex officio members or their designees:
(1) (text unchanged)
(2) The [Chief Medical Examiner] Secretary of Human Services;
(3) The Deputy Secretary of the Health Care Financing Administration;
[(3)] (4) The Director of the Vital Statistics Administration [of the Department];
[(4)] (5) The Director of the Prevention and Health Promotion Administration [of the Department];
(6) The Director of the Behavioral Health Administration;
[(5)] (7) The Director of the Maternal and Child Health Bureau [of the Department];
(8) The Chief Medical Examiner;
(9) The Director of the Office of Minority Health and Health Disparities;
[(6)] (10) The Director of the Office of Health Care Quality [of the Department];
(11) The Executive Director of the Maryland Health Care Commission;
[(7)] (12) (text unchanged)
[(8)] (13) The Executive Director of [the Maryland State Medical Society (MedChi)] the Medical and Chirurgical Faculty of Maryland;
[(9) The Executive Director of the Maryland Health Care Commission;]
[(10)] (14)–[(11)] (15) (text unchanged)
[(12)] (16) The Chair of the Maryland Section of the American College of [Obstetrics] Obstetricians and [Gynecology] Gynecologists;
[(13) The President of the Obstetrical and Gynecologic Society of Maryland;]
[(14)] (17)—[(16)] (19) (text unchanged)
[(17)] (20) The Chair of the Maryland State Child Fatality Review Team; and
[(18)] (21) (text unchanged)
C. Appointed Members.
(1) 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.
[(1)] (2) The Secretary [shall] 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, [and] or early childhood or other related disciplines as considered necessary by the Secretary to carry out the Committee’s responsibilities.
[(2)] (3) (text unchanged)
D. Designation of Representatives. An ex officio member described under §B of this regulation may designate another individual [from the member’s agency, department, office, or organization] to represent the member on the Committee from the member’s:
(1) Agency;
(2) Department;
(3) Office; or
(4) Organization.
E. Invitees. The Secretary may invite representatives from other agencies and organizations, and individuals involved in the prevention or reduction of morbidity [and] or mortality associated with pregnancy, childbirth, infancy, [and] or early childhood, to attend a Committee meeting if the representative has information that may be necessary to inform the Committee.
F.—I. (text unchanged)
.06 Committee Duties.
A. To achieve its purpose, the Committee shall:
[(1) Develop protocols for data collection regarding morbidity and mortality related to pregnancy, childbirth, infancy, and early childhood;]
[(2)] (1) Provide consultation to [local fetal and infant mortality review (FIMR)] FIMR teams and other [local morbidity, mortality, and quality review (MMQR)] MMQR teams [on the implementation and use of data collection protocols];
[(3)] (2)—[(4)] (3) (text unchanged)
[(5) Determine factors contributing to morbidity and mortality related to pregnancy, childbirth, infancy, and early childhood based upon the case reviews under §A(2) of this regulation and develop recommendations to address the contributing factors;]
[(6)] (4) Monitor hospital compliance with the Maryland Perinatal System Standards by [reviewing records]:
(a) Reviewing documents requested [in writing] of the hospital in writing or by conducting on-site reviews, or by both; and [making]
(b) Making recommendations to improve or facilitate compliance; and
[(7) Examine the policies and procedures of State and local agencies, hospitals, and other entities that participate in the system of care and review specific cases regarding pregnancy, childbirth, infancy, or early childhood that the Committee considers necessary to perform its duties;]
[(8) Develop] (5) 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[; and
(9) Coordinate its activities with other State agencies in order to avoid unnecessary duplication of effort].
B. The Committee may:
(1) (text unchanged)
(2) Establish special panels or ad hoc subcommittees of the Committee as necessary [in response to an identified profile or cluster of morbidity or mortality to provide special attention to a specific category of morbidity or mortality associated with pregnancy, childbirth, infancy, and early childhood; and] to carry out the duties of the Committee;
(3) Analyze data and review reports or other information from [local]:
(a) FIMR teams [or other local];
(b) Other MMQR teams; or
(c) Other entities which are established for the purpose of addressing [any] an aspect of morbidity, mortality, [and] or quality reviews associated with pregnancy, childbirth, infancy, [and] or early childhood[.];
(4) Develop protocols for data collection regarding morbidity and mortality related to pregnancy, childbirth, infancy, and early childhood;
(5) Examine the policies and procedures of State and local agencies, hospitals, and other entities that participate in the system of care;
(6) Review specific cases regarding pregnancy, childbirth, infancy, or early childhood that the Committee considers necessary to perform its duties; and
(7) Coordinate its activities with other State agencies in order to avoid unnecessary duplication of effort.
.07 Local Teams — Establishment and Purpose.
A. A jurisdiction shall have a multidisciplinary and multiagency [local] FIMR team or other [local] MMQR team.
B. The purpose of a [local] FIMR team is to facilitate the reduction of fetal and infant deaths by:
(1) Conducting confidential case reviews of fetal and infant deaths including the examination of [all] available medical and healthcare information involving fetal and infant mortality; and
(2) Based on the findings of the case reviews conducted under §B(1) of this regulation:
(a)—(c) (text unchanged)
(d) Informing the Committee of changes [in local law, policy, or practices] that [effect] affect fetal and infant deaths in:
(i) Local law;
(ii) Policy; or
(iii) Practices.
C. A [local] FIMR team shall:
(1)—(2) (text unchanged)
D. A [local] FIMR team may:
(1) (text unchanged)
(2) Establish protocols [for data collection, analysis, and reporting] in compliance with State statutes and regulations, as applicable, for:
(a) Data collection;
(b) Analysis; and
(c) Reporting.
.08 [Local] FIMR Teams — Membership.
A. Members of a [local] 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.
B. A [local] FIMR team shall appoint a [chairperson] chairman from among its membership.
C. A [local] 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.
D. A [local] FIMR team shall include at least one representative from:
(1) Public health programs, such as [maternal]:
(a) Maternal and child health[, substance];
(b) Substance abuse[, and mental]; or
(c) Mental health;
(2) Health care [providers] provider specialties, such as [obstetrics, pediatrics, social work, nursing, and nurse midwifery]:
(a) Obstetrics;
(b) Pediatrics;
(c) Social work;
(d) Nursing; or
(e) Nurse midwifery; and
(3) (text unchanged)
E. A [local] FIMR team may include representatives from other agencies or community organizations involved with the prevention or reduction of fetal and infant deaths.
.09 [Local] MMQR Teams — General.
[Local] MMQR teams may:
A. Inform the Committee of changes [in local law, policy, or practice] that affect morbidity [and] or mortality associated with pregnancy, childbirth, infancy, [and] or early childhood in:
(1) Local law;
(2) Policy; or
(3) Practice; and
B. (text unchanged)
.10 Types of Committee Reviews.
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:
A. Individual cases or clusters of cases of morbidity or mortality [identified by local team reviews];
B. Maternal or neonatal transport to or from perinatal centers; and
C. Aggregate or hospital-specific cases of [maternal or neonatal] mortality or morbidity[;] associated with pregnancy, childbirth, infancy, or early childhood.
[D. Voluntary compliance of Maryland hospitals that offer obstetric or neonatal services with the current Maryland Perinatal System Standards, as determined by:
(1) Data obtained from records of the hospital; or
(2) On-site review of the perinatal center;
E. Early childhood asthma-related deaths;
F. Morbidities associated with pregnancy, childbirth, infancy and early childhood, such as:
(1) Maternal morbidities, such as hemorrhage, embolus, or substance abuse during pregnancy or childbirth;
(2) Neonatal morbidities, such as sepsis, chronic lung disease, or retinopathy of prematurity;
(3) Sudden infant death syndrome and sudden unexplained death in infancy; and
(4) Lead poisoning (blood lead level greater than or equal to 20 micrograms per deciliter).]
.11 Access to Records and Information.
A. 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, [local] FIMR team, other [local] MMQR team, or their staff, provide access to records concerning:
(1)—(2) (text unchanged)
(3) The health care provided by [a]:
(a) A health care provider[,];
(b) A health care facility[, and emergency]; or
(c) Emergency medical services [(EMS)];
(4) [EMS] Emergency medical services system data on maternal and neonatal transport;
(5) State vital records data related to morbidity or mortality associated with pregnancy, childbirth, infancy, [and] or early childhood; and
(6) Documentation relevant to the purpose and duties of the Committee, [local] FIMR team, or other [local] MMQR team that is maintained by [any] a State or local government agency, including:
(a)—(b) (text unchanged)
B. The Committee, [local] FIMR team, or other [local] MMQR team shall assign staff to abstract information from patient medical records and other sources of information to which the Committee, [local] FIMR teams, or other [local] MMQR teams are entitled under §A of this regulation. [All such information]
C. Information abstracted under §B of this regulation shall be de-identified by the abstractor to remove [any] information that would permit the identification of [any] an individual health care recipient before the information may be used to carry out the purpose and duties of the Committee, [local] FIMR team, or other [local] MMQR team.
.12 Meetings.
A. (text unchanged)
B. [Local] FIMR teams shall meet at least quarterly.
C. [All meetings] A meeting of the Committee, [local] FIMR teams, or other [local] MMQR teams shall be closed to the public and [are] is not subject to [State Government Article, Title 10, Subtitle 5] General Provisions Article, Title 3, Subtitle 3, Annotated Code of Maryland, when the Committee, local FIMR team, or other [local] MMQR team is reviewing cases of pregnancy, childbirth, infancy, or early childhood.
D. The Committee, [local] FIMR team, or other [local] MMQR team may invite an individual who is not a member to attend a Committee, [local] FIMR team, or other [local] MMQR team meeting if:
(1) The attendance is approved in advance by the Committee, [local] FIMR team, or other [local] MMQR team chairperson;
(2) Participation of the invited individual is intended to assist the Committee, [local] FIMR team, or other [local] MMQR team in carrying out its duties; and
(3) Invitees in attendance abide by the same confidentiality and nondisclosure requirements which govern the Committee, [local] FIMR team, and other [local] MMQR team members.
.13 Confidentiality of Records and Information.
A. The following shall be held confidential and may not be released to [any] a person except as provided in this chapter:
(1) Records and information received by the Committee, [local] FIMR team, or other [local] MMQR team;
(2) (text unchanged)
(3) Minutes of meetings of the Committee, [local] FIMR team, or other [local] MMQR team.
B. [All information] Information and records obtained by the Committee, a [local] FIMR team, or other [local] MMQR team are exempt from disclosure under [State Government Article, Title 10, Subtitle 6] General Provisions Article, Title 4, Annotated Code of Maryland.
C. The Committee, a [local] FIMR team, or other [local] MMQR team may not discuss, disclose, or use information for purposes other than as necessary to carry out the Committee’s, [local] FIMR team’s, or other [local] MMQR team’s duties and purposes under this chapter.
D. [Any information] Information that is disclosed to the public by the Committee, [local] FIMR team, or other [local] MMQR team shall be de-identified and may not contain [any] information that would permit the identification of [any] an individual, a health care provider, or a health care facility.
E. The Committee, a [local] FIMR team, or other [local] MMQR team may release specific findings that relate to aggregate data as well as recommendations made by the Committee, [local] FIMR team, or other [local] MMQR team to prevent and reduce morbidity and mortality[. This], and this information shall be public record.
F. The Committee, [local] FIMR team, other [local] MMQR team, or their staff shall maintain the confidentiality of information used or addressed at meetings.
G. A person in attendance at a meeting of the Committee, a [local] FIMR team, or other [local] MMQR team may not testify or be required to testify as to what transpired at that part of the meeting that is closed under [State Government Article, Title 10, Subtitle 5] General Provisions Article, Title 3, Subtitle 3, Annotated Code of Maryland.
[G.] H. A member of the Committee, [local] FIMR team, other [local] MMQR team, their staff, or invitees may not be questioned in [any] a civil or criminal proceeding regarding information presented at or opinions formed as a result of a closed Committee, [local] FIMR team, or other [local] MMQR team meeting.
[H.] I. A member of the Committee, [local] FIMR team, other [local] MMQR team, their staff, or invitees, may testify in a civil or criminal proceeding to information that is:
(1) Obtained independent of the Committee, [local] FIMR team, or other [local] MMQR team; and
(2) (text unchanged)
[I.] J. [All information] Information, documents, and records of the Committee, a [local] FIMR team, or other [local] MMQR team are not subject [to subpoena, discovery, or introduction as evidence], in [any] a civil or criminal proceeding, to:
(1) Subpoena;
(2) Discovery; or
(3) Introduction as evidence.
[J.] K. [All information] Information, documents, and records obtained by the Committee, a [local] FIMR team, or other [local] MMQR team that are available from other sources may be subject [to subpoena, discovery, or introduction into evidence], as provided by applicable law, to:
(1) Subpoena;
(2) Discovery; or
(3) Introduction into evidence.
[K.] L. A person may not be held liable for civil damages or subject to [any] a criminal or disciplinary action for good faith efforts made to comply with the provisions of this chapter.
DENNIS SCHRADER
Secretary of Health
