Iowa Code r. 641-4.7 - [Effective until 8/1/2025] Iowa registry for congenital and inherited disorders (IRCID)
This program provides active statewide surveillance for congenital and inherited disorders. These disorders may include birth defects, neuromuscular disorders, metabolic disorders, and all stillbirths. The program also may conduct active statewide surveillance of live births without a reportable congenital or inherited disorder to serve as controls for epidemiological surveys. Surveillance activities for specific congenital and inherited disorders will be conducted for the period of time that adequate financial support is available.
(1)
Definitions.
a. Birth defects
shall be defined as any major structural abnormality or metabolic disorder that
may adversely affect a child's health and development. The abnormality or
disorder must be diagnosed or its signs and symptoms must be recognized within
the first two years of life.
b.
Neuromuscular disorders shall be defined as Duchenne, Becker, congenital,
distal, Emery-Dreifuss, fascioscapulohumeral, limb-girdle, myotonic, and
oculopharyngeal muscular dystrophies.
c. Rescinded IAB 4/3/13, effective
5/8/13.
d. Stillbirths shall be
defined as an unintended fetal death occurring after a gestational period of 20
completed weeks or an unintended fetal death of a fetus with a weight of 350 or
more grams. Stillbirth is synonymous with fetal death.
e. A reportable congenital or inherited
disorder occurring in a miscarriage or pregnancy may be included in the
IRCID.
(2)
Surveillance policy.
a.
Congenital disorders, including birth defects, occurring in Iowa are reportable
conditions, and records of these disorders shall be abstracted pursuant to
641-1.3 (139A) and maintained in
the IRCID. Congenital disorders surveillance shall be performed in order to
determine the occurrence and trends of such disorders, to determine
co-occurring conditions and treatments through annual follow-up abstraction, to
conduct thorough and complete epidemiological surveys to identify environmental
and genetic risk factors for congenital disorders, to contribute to prevention
strategies, and to assist in the planning for and provision of services to
children with congenital disorders and their families.
b. Records for neuromuscular disorders shall
be abstracted pursuant to
641-1.3 (139A) and maintained in
the IRCID. Neuromuscular disorders surveillance for individuals of all ages
shall be performed in order to determine the occurrence and trends of the
selected neuromuscular disorders, to determine co-occurring conditions and
treatments through annual follow-up abstraction, to conduct thorough and
complete epidemiological surveys through annual long-term follow-up, and to
assist in the planning for and provision of services to individuals with
selected neuromuscular disorders and their families.
c. Rescinded IAB 4/3/13, effective
5/8/13.
d. Stillbirths occurring in
Iowa are reportable conditions, and records of these stillbirths shall be
abstracted pursuant to
641-1.3 (139A) and maintained in
the IRCID. Stillbirth surveillance shall be performed in order to determine the
occurrence and trends of stillbirths, to conduct thorough and complete
epidemiological surveys to identify environmental and genetic risk factors for
stillbirths, and to assist in the planning for and provision of services to
prevent stillbirths.
(3)
IRCID activities.
a. The
center shall establish an agreement with the University of Iowa to implement
the activities of the IRCID.
b. The
IRCID shall use the birth defects, neuromuscular disorders, metabolic
disorders, and stillbirth coding schemes developed by the Centers for Disease
Control and Prevention (CDC).
c.
The IRCID staff shall review hospital records, clinical charts, physician's
records, vital records, prenatal records, and fetal death evaluation protocols
pursuant to 641-1.3 (139A), information from
the INSP, RGCS, NMP, and the IMPSP, and any other information that the IRCID
deems necessary and appropriate for congenital and inherited disorders
surveillance.
(4)
Department responsibility.
a.
When a live infant's medical records are ascertained by the IRCID, the
department or its designee shall inform the parent or legal guardian by letter
that this information has been collected and provide the parent or guardian
with information about services for which the child and family may be
eligible.
b. The center and the
IRCID shall annually release aggregate medical and epidemiological information
to medical personnel and appropriate state and local agencies for the planning
and monitoring of services for children with congenital or inherited disorders
and their families.
(5)
Confidentiality and disclosure of information. Reports,
records, and other information collected by or provided to the IRCID relating
to a person known to have or suspected of having a congenital or inherited
disorder are confidential records pursuant to Iowa Code sections
22.7 and
136A.7.
a. Personnel of the IRCID and the department
shall maintain the confidentiality of all information and records used in the
review and analysis of congenital or inherited disorders, including information
which is confidential under Iowa Code chapter 22 or any other provisions of
state law.
b. IRCID staff are
authorized pursuant to
641-1.3 (139A) to gather all
information relevant to the review and analysis of congenital or inherited
disorders. This information may include, but is not limited to, hospital
records, physician's records, clinical charts, vital records, prenatal records,
fetal death evaluation protocols, information from the INSP, RGCS, NMP, and the
IMPSP, and any other information that the IRCID deems necessary and appropriate
for congenital and inherited disorders surveillance. IRCID staff are permitted
to review hospital records, clinical charts, physician's records, vital
records, and prenatal records, information from the INSP, RGCS, NMP, and IMPSP
and any other information that the IRCID deems necessary and appropriate for
live births without a reportable congenital or inherited disorder to serve as
controls for epidemiological surveys.
c. No individual or organization providing
information to the IRCID in accordance with this rule shall be deemed or held
liable for divulging confidential information.
(6)
Access to information in the
IRCID. The IRCID and the department shall not release confidential
information except to the following, under the following conditions:
a. The parent or guardian of an infant or
child for whom the report is made and who can demonstrate that the parent or
guardian has received the notification letter.
b. An Early ACCESS service coordinator or an
agency under contract with the department to administer the children with
special health care needs program, upon receipt of written consent from the
parent or guardian of the infant or child.
c. A local health care provider, upon receipt
of written consent from the parent or guardian of the infant or
child.
d. A representative of a
federal agency, to the extent that the information is necessary to perform a
legally authorized function of that agency or the department. The information
provided shall not include the personal identifiers of an infant or child with
a reportable congenital or inherited disorder.
e. Researchers, in accordance with the
following:
(1) All proposals for research
using the IRCID data to be conducted by persons other than program staff shall
first be submitted to and accepted by the researcher's institutional review
board. Proposals shall then be reviewed and approved by the department and the
IRCID's internal advisory committee before research can commence.
(2) The IRCID shall submit to the IRCID's
internal advisory committee for approval a protocol describing any research
conducted by the IRCID in which the IRCID deems it necessary to contact case
subjects and controls.
f.
A representative of a state agency, to the extent that the information is
necessary to perform a legally authorized function of that agency or the
department. The state agency will be subject to confidentiality regulations
that are the same as or more stringent than those in the state of
Iowa.
Notes
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