Current through Register Vol. 47, No. 6, September 18, 2024
This program provides comprehensive maternal prenatal
screening services for the state.
(1)
Maternal screening policy. It shall be the policy of the state
of Iowa that all pregnant women are offered maternal prenatal screening. The
Iowa maternal prenatal screening program provides a risk assessment for open
neural tube defects, ventral wall defects, Down syndrome, and Trisomy 18.
a. If a patient desires this screening test,
her health care provider shall direct that a specimen be drawn and submitted to
the SHL.
b. As new technologies and
tests become available, the center shall follow protocols developed by the
department with regard to the addition of disorders to or the deletion of
disorders from the screening program.
(2)
Maternal screening
procedure.
a.
Collection of
specimens. A serum or clotted blood specimen shall be collected from
the patient within the appropriate gestational range indicated by the requested
screen.
b.
Processing of
specimens. The SHL shall test specimens within three working days of
receipt.
c.
Reporting of
abnormal results. Abnormal screen results shall be reported within 24
hours to the consulting physician or the physician's designee who shall then
notify the primary health care provider. On the next working day, this initial
report shall be followed by a written report to the primary health care
provider.
(3)
Consulting physician responsibility. A consulting physician
shall be designated by the center in collaboration with the SHL to provide
interpretation of screen results and consultation to the submitting health care
provider. This physician shall provide consultation for abnormal screen
results, assist with questions about management of identified cases, provide
education and assist with quality assurance measures. The screening program,
with assistance from the consulting physician, shall:
a. In collaboration with the SHL, submit a
proposed budget and narrative justification for the upcoming fiscal year to the
center by January 31 of each year, and
b. Submit a written annual report of the
previous calendar year to the center by July 1 of each year. The report shall
include:
(1) Number of women
screened,
(2) Number of repeat
screens,
(3) Number of abnormal
results by disorder,
(4) Number of
rejected specimens,
(5) Results of
quality assurance testing, and
(6)
Screening and educational activity details.
(4)
SHL responsibility. The
SHL shall:
a. Contract with a courier service
to provide transportation and delivery of maternal prenatal serum
specimens.
b. Contact all entities
submitting specimens to inform them of the courier's schedule.
c. Test specimens within three working days
of receipt.
d. Distribute specimen
collection kits and other materials to health care provider offices and drawing
facilities as required.
e. Inform
the submitting health care provider or drawing facility of an unacceptable
specimen and request another specimen.
f. Provide educational materials concerning
specimen collection procedures.
g.
Have available for review a written quality assurance program covering all
aspects of its screening activity.
h. Act as a fiscal agent for program charges
encompassing the analytical, technical, administrative, educational and
follow-up costs for the screening program.
(5)
LMPSP fee determination.
The department shall annually review and determine the fee to be charged for
all activities associated with the IMPSP. The review and determination of the
fee shall be completed at least one month prior to the beginning of the fiscal
year.
(6)
Sharing of
"information and confidentiality. Reports, records, and other
information collected by or provided to the IMPSP relating to a patient's
maternal prenatal screening results and follow-up information are confidential
records pursuant to Iowa Code section
22.7.
a. Personnel of the program shall maintain
the confidentiality of all information and records used in the review and
analysis of maternal serum screening and follow-up, including information that
is confidential under Iowa Code chapter 22 or any other provisions of state
law.
b. The program shall not
release confidential information except to the following persons and entities,
under the following conditions:
(1) The
patient for whom the report is made.
(2) A primary health care provider or
submitting laboratory.
(3) A
representative of a state or federal agency, to the extent that the information
is necessary to perform a legally authorized function of that agency or the
department. The state or federal agency will be subject to confidentiality
regulations which are the same as or more stringent than those in the state of
Iowa.
(4) A researcher, upon
documentation of patient consent obtained by the researcher, and only to the
extent that the information is necessary to perform research authorized by the
department and the state board of health.
(7)
Retention, use and disposition of
residual maternal prenatal screening specimens.
a. A maternal serum screening specimen
collection consists of laboratory tubes with maternal serum and associated
information about the patient, health care provider, or drawing laboratory.
(1) The residual serum specimens shall be
held for a specified period of time in a locked area at the SHL in accordance
with SHL policy and procedures.
(2)
Reserved.
b. Research
use.
(1) Investigators shall submit proposals
to use residual serum specimens to the center. Any intent to utilize
information associated with the requested specimens as part of the research
study must be clearly delineated in the proposal.
(2) Before research can commence, proposals
shall be approved by the researcher's institutional review board, the
congenital and inherited disorders advisory committee, and the
department.
(3) Personally
identifiable residual specimens or records shall not be disclosed without
documentation of informed patient consent obtained by the researcher.
(4) Research on anonymized or identifiable
residual specimens shall be allowed in instances where research would further
maternal prenatal screening activities or general medical knowledge for
existing public health surveillance activities.
