subchapter 47C – birth defects monitoring program
SECTION .0100 - MONITORING PROGRAM
10A NCAC 47C .0101 GENERAL
(a) This Section implements G.S. 130A, Article 5, Part 7
entitled Birth Defects. The legislation establishes a Birth Defects Monitoring
Program within the State Center for Health Statistics. The purpose of the
monitoring program is to compile, tabulate and publish information related to
the incidence and prevention of birth defects.
(b) The Birth Defects Monitoring Program is administered by
the State Center for Health Statistics, Department of Health and Human
Services.
History Note: Authority G.S. 130A-131.17;
Eff. August 1, 2000.
10A NCAC 47C .0102 DEFINITIONS
The following definitions shall apply throughout this
Section:
(1) "Abstract" refers to a document or
documents containing information obtained from a patient's medical record.
(2) "Birth Defect" means any physical, functional
or chemical abnormality present at birth that is of possible genetic or
prenatal origin.
(3) "Case-Finding" is the process used to
identify potential cases for inclusion in the central registry of the Birth
Defects Monitoring Program. Potential cases may be ascertained through review
of medical records, disease indices, logs, vital records, hospital discharge
summaries, and other sources.
(4) "Central Registry" is the database of
birth defect cases obtained through the surveillance activities of the Birth
Defects Monitoring Program.
(5) "Confidential Information" is any
information that could be used to reveal, either directly or indirectly, the
identity of a patient with a birth defect.
(6) "Department" is the NC Department of
Health and Human Services.
(7) "Director" is the Director of the State Center for Health Statistics (SCHS).
(8) "ICD-9-CM" means the International
Classification of Diseases, 9th Revision, Clinical Modification, Volumes 1 and
2, US Department of Health and Human Services, US Government Printing Office, Washington, DC.
(9) "Institutional Review Board" means a
committee for the protection of human subjects which is approved by the US
Department of Health and Human Services pursuant to Part 46 of Title 45 of the
Code of Federal Regulations.
(10) "Licensed Medical Facility" means general
acute care hospitals and ambulatory surgical facilities licensed by the
Department of Human Resources pursuant to G.S. 131E-77, which regularly provide
services for the diagnosis and treatment of birth defects, genetic counseling,
or prenatal diagnostic services.
(11) "Monitoring Program" means the Birth
Defects Monitoring Program (BDMP) established within the Department.
(12) "Program Director" is the individual
directly responsible for oversight and operation of the Birth Defects
Monitoring Program.
(13) "Program Staff" means employees of the
State Center for Health Statistics or persons providing services to SCHS under
written contract who are authorized by the director to collect and have access
to information from the monitoring program.
History Note: Authority G.S. 130A-131.17;
Eff. August 1, 2000.
10A NCAC 47C .0103 BIRTH DEFECTS ADVISORY COMMITTEE
(a) The State Health Director shall establish a birth
defects advisory committee to provide practical and scientific advice to the
monitoring program in implementing an effective birth defects surveillance
program.
(b) The advisory committee shall be composed of not more
than 12 members and must include scientific experts in the fields of birth
defects, genetics, epidemiology, and medicine. At least one member must have a
background in a non-scientific area. At least one member must be a
representative of the facilities from which the data will be collected. The
Director of the monitoring program shall serve as ex officio member of the
advisory committee.
(c) The birth defects advisory committee shall:
(1) Provide scientific and medical advice and
consultation to the monitoring program; and
(2) Make recommendations to the Department or
the state legislature, as appropriate.
History Note: Authority G.S. 130A-131.17;
Eff. August 1, 2000.
10A NCAC 47C .0104 SURVEILLANCE OF BIRTH DEFECTS; CENTRAL
REGISTRY
(a) The monitoring program shall operate statewide.
(b) In order for information on a child to be included in
the monitoring program's central registry, the following conditions must be
met:
(1) The state of birth or the mother's state of
residence at the time of birth must have been in North Carolina; and
(2) The child must have a birth defect or other
specified perinatal condition that can adversely affect his or her health and
development.
(c) The central registry shall include birth defects
occurring in a fetal death, miscarriage, or pregnancy termination.
(d) The coding scheme used by the monitoring program to
classify birth defects shall be based on a medically recognized system, such as
ICD-9-CM or the CDC/BPA system used by the Centers for Disease Control and
Prevention in the Metropolitan Atlanta Congenital Defects Program, as described
in the report titled "Metropolitan Atlanta Congenital Defects Program
Procedure Manual," dated June, 1993.
(e) The program director shall, in consultation with the
birth defects advisory committee, develop a list of specific birth defects to
be monitored. In developing this list consideration shall be given to the
following:
(1) The medical and public health significance
of the condition, including potential preventability;
(2) The feasibility of obtaining reasonably
complete and reliable diagnostic information on the condition from the data
sources available to the monitoring program; and
(3) The consistency with birth defects data
collected and reported by the Centers for Disease Control and Prevention and by
other state-based birth defects surveillance programs.
(f) The monitoring program may utilize for case
ascertainment any data source routinely collected by or available to the State Center for Health Statistics, such as vital records, hospital discharge information,
and Health Services Information System files.
(g) The monitoring program may, upon request, review and
abstract information on a diagnosed or suspected birth defect from any medical
record in a licensed medical facility. When obtaining such information the
following conditions shall apply:
(1) The administrator, director, or person in
charge of a licensed medical facility shall designate one staff member as the
contact person for the monitoring program. That staff member will coordinate
scheduled visits by program staff to review disease indices, labor and delivery
logs, or other case-finding data sources. That person will also be responsible
for arranging visits by program staff for medical records review;
(2) Monitoring program staff and the contact
person shall establish a general schedule of case-finding and record review
visits. This schedule shall take into account the capabilities of the medical
facility in responding to requests, as well as the expected needs and workload
of the monitoring program;
(3) Procedures for record management and the
use of copiers and other equipment at the medical facility shall be agreed upon
with each facility. Monitoring program staff shall abide by these procedures
at all times; and
(4) The medical records and other original
materials provided by the medical facility shall not be removed from that
facility. All information, either on paper or in electronic form, which is
removed from the medical facility shall be transported by secure means at all
times. Abstracts, printouts, notes, and other information will be carried in
locked briefcases.
(h) Physicians and other persons involved in the diagnosis,
care, and treatment of birth defects may report information on a diagnosed
birth defect to the monitoring program. Physicians and other persons who
submit a case report or other information to the monitoring program shall be
immune from civil or criminal liability that might otherwise be incurred or
imposed for releasing this information based upon invasion of privacy or breach
of physician-patient confidentiality.
History Note: Authority G.S. 130A-131.17;
Eff. August 1, 2000.
10A NCAC 47C .0105 CONFIDENTIALITY
(a) Access to patient-level information collected by the
monitoring program shall be limited to program staff authorized by the doctor.
(b) All program staff shall be required to sign an
agreement to actively protect the confidentiality of patient information
collected through the monitoring program.
(c) All identifying or potentially identifying information
collected by the monitoring program, including abstracts, case reports,
computer printouts, notes and other material shall be stored in locked offices
or in locked file cabinets at all times.
(d) Central registry files stored in electronic format
shall be maintained in a password-protected local area computer network. Only
authorized program staff shall have access to this information. Access to the
data is controlled by the network administrator. Back up data files shall be
maintained at the State Computer Center. This computer system is protected by
the Resource Allocation Control Facility (RACF) system.
(e) A publicly accessible data file containing limited
patient-level information from the central registry may be made available.
This file may contain the following data items only: county of residence,
county of birth, year of birth, sex of infant, race of infant, age of mother,
and birth defect diagnoses. All other patient information contained in the
central registry shall be considered confidential and not open to public
inspection, except as specified in Paragraph (f) of this Rule.
(f) Confidential information maintained in the central
registry may be disclosed in the following circumstances, when authorized by
the Director:
(1) A patient shall have access to review or
obtain copies of his/her own records; or
(2) Information may be disclosed as provided in
Rule .0106 of this Section.
History Note: Authority G.S. 130A-131.17;
Eff. August 1, 2000.
10A NCAC 47C .0106 RELEASE OF MONITORING PROGRAM
INFORMATION FOR RESEARCH
(a) Individuals other than authorized program staff
requesting access to confidential monitoring program information for research
purposes must establish a valid scientific interest in order to obtain this
information. An application requesting access to monitoring program
information must contain a research protocol and be submitted to the Director.
The protocol shall contain the following information:
(1) The name and qualifications of the
principal investigator, professional staff, and every person who will review,
analyze, or access the data;
(2) The purpose of the research;
(3) The research design and statistical methods
to be used to analyze the data;
(4) The proposed benefits to be derived from
such research and the potential risk to human subjects; and
(5) The plans and procedures to maintain the
confidentiality of information provided by the monitoring program.
(b) The criteria to establish a valid scientific interest
shall include the following:
(1) The key investigators shall have
significant training and experience in biomedical research as demonstrated by a
history of prior research and publication of results in peer-reviewed
journals. For bona fide student proposals and research carried out for
educational purposes, faculty committee members should possess these
qualifications;
(2) The purpose of the research shall be
clearly stated, and the hypotheses under investigation shall be scientifically
compelling, as judged by the importance of the question relative to the fields
of epidemiology, medicine, or public health;
(3) The research design shall be scientifically
sound with respect to exposure measurement, assessment and control of other
relevant risk factors, and statistical power. Statistical techniques to be
used in the analysis shall be clearly described and appropriately applied;
(4) The benefits of the proposed research, and
the potential risk to individuals whose identity may be disclosed or who are
involved as study participants must be clearly stated;
(5) Plans of how the investigators propose to
maintain the confidentiality and integrity of the information provided by the
monitoring program shall be clearly detailed and must adequately protect the
security of the data;
(6) The hypothesis or topic to be studied must
not already be under investigation; and
(7) If the investigator intends to contact
individuals whose names were provided by the monitoring program, the protocol
must contain strong methodologic support for the need for such contact.
(c) Before any data are released, the investigator will be
required to submit to the Director a signed written statement guaranteeing the
following:
(1) The investigator has received written
approval of the research protocol from an Institutional Review Board;
(2) The investigator shall not allow any person
other than those identified in the protocol to access, use, or otherwise review
the data supplied by the monitoring program;
(3) There shall be no deviation from the
protocol without explicit advance review and approval by the Director and the
Institutional Review Board;
(4) Information obtained in the course of
activities undertaken or supported using the data from the monitoring program
shall not be used for any purpose other than the exact purpose for which it was
supplied; and
(5) Any confidential or potentially identifying
information supplied by the monitoring program which is copied or otherwise
transferred shall be destroyed upon completion of the study unless otherwise
stated in the research protocol.
(d) Upon completion of the study, the investigator shall
submit one copy of the completed research paper or abstract to the Director.
History Note: Authority G.S. 130A-131;
Eff. August 1, 2000.
