Link to law: http://reports.oah.state.nc.us/ncac/title 10a - health and human services/chapter 47 - information services/subchapter c/subchapter c rules.html
Published: 2015

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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.