Rule 44:19 NEWBORN SCREENING
Rule 44:19:01 DEFINITIONS
Rule 44:19:01:01 Definitions.
44:19:01:01. Definitions. Terms used in this article
mean:
(1) "Abnormal
specimen," a newborn's blood specimen that is defined as positive for
reporting purposes;
(2) "Birth
attendant," a person licensed or certified by the state under SDCL title 36 to provide maternity care and to deliver pregnant women;
(3) "Days of
age," the measurement of the age of a newborn in 24-hour periods; i.e., a
newborn is one day of age 24 hours following the hour of birth;
(4) "Department,"
the South Dakota Department of Health;
(5) "Designated
laboratory," a laboratory or laboratories authorized by the department
pursuant to § 44:19:02:03.01 to perform newborn screening services for
infants born in South Dakota;
(6) "Filter paper
specimen," a sample of blood collected from an infant by saturating marked
areas of a filter paper card with blood obtained by skin puncture of the heel;
(7) "Discharge,"
the release of a newborn from the care of an institution or hospital to the
parents or into the community;
(8) "Initial
specimen," the first metabolic screening specimen collected subsequent to
birth;
(9) "Initial
test," the first valid metabolic screening test or combination of tests of
a newborn for each disorder;
(10) "Metabolic
disorder," a malfunction in the processes that convert compounds to
protoplasm, energy, and waste;
(11) "Newborn,"
an infant 28 days of age or under;
(12) "Newborn's
physician," the physician responsible for the care of a newborn;
(13) "Newborn
screening," a laboratory test performed on newborn blood specimens to
identify newborns with metabolic disorders;
(14) "Repeat
specimen," a specimen collected from a newborn because a previously
collected specimen was either unsatisfactory or the test results were
inconclusive, abnormal, or positive;
(15) "Repeat
test," a test repeated because the previous specimen or test results were
unsatisfactory, test results were not complete, or the test results were
abnormal;
(16) "Secretary,"
the secretary of the department of health;
(17) "Submitter,"
the person who sends the newborn screening requisition form to the designated
laboratory for initial, repeat, or confirmatory screening tests, including the
hospital, laboratory, or physician;
(18) "Transfer,"
the release of a newborn from the care of one institution or hospital to the
care of another institution or hospital;
(19) "TSH,"
thyroid stimulating hormone; and
(20) "Unacceptable or
unsatisfactory specimen," a newborn's blood specimen that is not suitable
in quality or quantity for performing newborn screening for one or more of the
disorders covered by this article.
Source:
12 SDR 167, effective April 20, 1986; 15 SDR 59, effective October 19, 1988; 18
SDR 67, effective October 16, 1991; 23 SDR 91, effective December 9, 1996; 31
SDR 164, effective May 9, 2005.
General
Authority: SDCL 34-24-25.
Law
Implemented: SDCL 34-24-23.
Rule 44:19:01:02 Transferred.
44:19:01:02. Transferred to § 44:19:02:03.
Rule 44:19:01:03 Repealed.
44:19:01:03. Deadlines for reporting test results.Repealed.
Source:
12 SDR 167, effective April 20, 1986; repealed, 15 SDR 59, effective October 19, 1988.
Rule 44:19:01:04 Required tests.
44:19:01:04. Required tests. In addition to those
metabolic disorders required in SDCL 34-24-18, any infant born in South Dakota shall be screened for the following metabolic disorders by a laboratory designated by the department to perform such testing:
(1) Hemoglobinopathies;
(2) Biotinidase deficiency;
(3) Classical congenital
adrenal hyperplasia;
(4) Fatty acid oxidation
disorders;
(5) Amino acid disorders;
(6) Organic acid disorders;
and
(7) Cystic fibrosis.
Source:
31 SDR 164, effective May 9, 2005; 33 SDR 180, effective May 7, 2007.
General
Authority: SDCL 34-24-25.
Law
Implemented: SDCL 34-24-22.
Rule 44:19:02 NEWBORN SCREENING LABORATORY
Rule 44:19:02:01 Repealed.
44:19:02:01. Newborn screening laboratory test requisition.Repealed.
Source:
15 SDR 59, effective October 19, 1988; repealed, 23 SDR 91, effective December 9, 1996.
Rule 44:19:02:02 Repealed.
44:19:02:02. Standards for laboratory operation.Repealed.
Source:
15 SDR 59, effective October 19, 1988; 18 SDR 67, effective October 16, 1991; repealed, 23 SDR 91, effective December 9, 1996.
Rule 44:19:02:03 Repealed.
44:19:02:03. Reporting
requirements.Repealed.
Source:
12 SDR 167, effective April 20, 1986; transferred
from § 44:19:01:02, 15 SDR 59, effective October
19, 1988; 18 SDR 67, effective October 16, 1991;
repealed, 23 SDR 91, effective December 9, 1996.
Rule 44:19:02:03.01 Designation of laboratories.
44:19:02:03.01. Designation of laboratories. In accordance
with criteria in § 44:19:02:03.02 the department shall designate the
laboratories that are authorized to perform newborn screening services for
infants born in of South Dakota. The number of laboratories to be designated at
any one time is at the discretion of the secretary.
Source:
23 SDR 91, effective December 9, 1996; 31 SDR 164, effective May 9, 2005.
General
Authority: SDCL 34-24-25.
Law
Implemented: SDCL 34-24-25.
Rule 44:19:02:03.02 Criteria for designation of laboratories.
44:19:02:03.02. Criteria
for designation of laboratories. The department shall
use the following criteria in designating laboratories to conduct newborn
screening tests:
(1) Professional
qualifications necessary for satisfactory performance of the required services;
(2) Demonstrated experience
and technical expertise;
(3) Demonstrated capacity
to accomplish work in the required time and maintain a continuity of services;
(4) Past performance on
similar contracts with publicly or privately funded programs in terms of cost
control, quality of work, and compliance with performance schedules;
(5) Proposed fee to be
charged per specimen for newborn screening; and
(6) Any other criteria as
deemed appropriate by the secretary.
Source:
23 SDR 91, effective December 9, 1996.
General
Authority:SDCL 34-24-25.
Law
Implemented:SDCL 34-24-25.
Rule 44:19:02:04 Public notice of designated laboratories.
44:19:02:04. Public notice of designated laboratories.
The department shall publish the names and addresses of the designated
laboratories authorized to conduct newborn screening tests.
Source:
15 SDR 59, effective October 19, 1988; 23 SDR 91, effective December 9, 1996.
General
Authority:SDCL 34-24-25.
Law
Implemented:SDCL 34-24-25.
Rule 44:19:02:04.01 Designated laboratory responsibilities.
44:19:02:04.01. Designated laboratory responsibilities. The
designated laboratory shall provide the following notices regarding specimens
received:
(1) Any unacceptable or
unsatisfactory specimen and the need for a repeat specimen shall be reported to
the submitter no later than 24 hours after the analysis or within four working
days of specimen receipt, whichever is earlier; and
(2) Any abnormal and
positive test results shall be reported to the submitter no later than 24 hours
after the analysis or within four working days after specimen receipt,
whichever is earlier.
Source:
31 SDR 164, effective May 9, 2005
General
Authority: SDCL 34-24-25.
Law
Implemented: SDCL 34-24-17, 34-24-23, 34-24-24.
Rule 44:19:02:05 Responsibilities of parents.
44:19:02:05. Responsibilities of parents. The parents,
guardian, or custodian of each infant is responsible for having blood tests for
metabolic disorders performed within the first 48 hours of an infant's life. If
a parent, guardian, or custodian refuses to have a newborn tested for metabolic
disorders, despite having been notified of the need for testing, the parent,
guardian, or custodian shall sign a written statement regarding the refusal.
Source:
18 SDR 67, effective October 16, 1991; 23 SDR 91, effective December 9, 1996;
31 SDR 164, effective May 9, 2005.
General
Authority: SDCL 34-24-25.
Law
Implemented: SDCL 34-24-17, 34-24-23, 34-24-24.
Rule 44:19:02:06 Responsibilities of hospitals, physicians, and other health professionals.
44:19:02:06. Responsibilities of hospitals, physicians, and
other health professionals. The attending physician, other health
professional, hospital, or public health facility shall notify the parents,
guardian, or custodian of each infant of the responsibility and need to have
the newborn screening tests performed. The attending physician or other health
professional shall place all newborn screening test results in the newborn
patient's record. If a parent, guardian, or custodian refuses to have the newborn
tested, the attending physician, other health professional, hospital, or public
health facility shall obtain a written signed statement from the parent,
guardian, or custodian of the infant regarding the refusal and place it in the
newborn patient's record, notify the department within 24 hours of the refusal
at 1-800-738-2301, and send a copy of the signed refusal to the department. If
a parent, guardian, or custodian refuses to sign the statement, the attending
physician, other health professional, hospital, or public health facility shall
document such refusal, place it in the newborn patient's record, and send a
copy of such documentation to the department.
Once the physician receives the
results of the newborn screening test, the physician shall place the results in
the newborn's medical record.
Source:
31 SDR 164, effective May 9, 2005.
General
Authority: SDCL 34-24-25.
Law
Implemented: SDCL 34-24-17, 34-24-23, 34-24-24.
Rule 44:19:02:07 Responsibilities of Department of Health.
44:19:02:07. Responsibilities of Department of Health.
Upon notification by a designated laboratory of a positive screening result for
an infant, the department shall work with the newborn's physician to locate the
infant and facilitate the entry of the infant into further diagnostic and
medical management services.
Source:
31 SDR 164, effective May 9, 2005.
General
Authority: SDCL 34-24-25.
Law
Implemented: SDCL 34-24-17, 34-24-23, 34-24-24.
Rule 44:19:03 TIME SEQUENCE FOR TESTING
CHAPTER 44:19:03
TIME SEQUENCE FOR TESTING
Section
44:19:03:01 Specimen submission to designated
laboratory.
44:19:03:02 Collection of filter paper specimens.
Rule 44:19:03:01 Specimen submission to designated laboratory.
44:19:03:01. Specimen submission to designated laboratory.
Specimens must be submitted to a designated laboratory. Only filter paper
specimens may be submitted for newborn screening.
Source:
15 SDR 59, effective October 19, 1988; 18 SDR 67, effective October 16, 1991; 23 SDR
91, effective December 9, 1996.
General
Authority:SDCL 34-24-25.
Law
Implemented:SDCL 34-24-18.
Rule 44:19:03:02 Collection of filter paper specimens.
44:19:03:02. Collection of filter paper specimens. Filter
paper specimens for submission to designated laboratories must be collected as
follows:
(1) A filter paper specimen
must be collected from each newborn infant as close as possible to the time of
discharge and no later than seven days by the institution or hospital where
initial or subsequent newborn care was provided regardless of prematurity,
illness, feeding history, or antibiotics being given. The designated laboratory
shall retain the specimen until the laboratory determines that the specimen can
be destroyed;
(2) Filter paper specimens
must be collected from newborns prior to a transfusion of whole blood, plasma,
or packed red blood cells regardless of the infant's age. If the pre-transfusion
specimen was collected before 24 hours of age, or if the initial specimen was
collected after a transfusion, the repeat specimen shall be collected as
determined by the designated laboratory's transfusion protocol for the testing
of disorders;
(3) The receiving
institution shall obtain filter paper specimens from newborns transferred
within the first 48 hours of life;
(4) The institution
initiating the transfer shall obtain blood specimens from newborns transferred
after the first 48 hours of life;
(5) If a birth occurs that
is not attended by a birth attendant, the local registrar shall inform the
parent or guardian of the need for a blood test for metabolic disorders when
inquiring about or filing a certificate of birth. The registrar shall inform
the parent or guardian where the blood sample may be drawn or refer them to the
local community health nurse; and
(6) For any specimen
collected on a newborn less than 24 hours of age, a repeat specimen must be
collected within two weeks.
Source:
15 SDR 59, effective October 19, 1988; 23 SDR 91, effective December 9, 1996;
31 SDR 164, effective May 9, 2005; 33 SDR 180, effective May 7, 2007.
General
Authority: SDCL 34-24-25.
Law
Implemented: SDCL 34-24-18.
Rule 44:19:04 CONSULTATION
CHAPTER 44:19:04
CONSULTATION
Section
44:19:04:01 Consultation services.
Rule 44:19:04:01 Consultation services.
44:19:04:01. Consultation services. The department shall
contract with a consulting physician to provide interpretation of test results
and consultation to the attending physician on request.
Source:
15 SDR 59, effective October 19, 1988; 23 SDR 91, effective December 9, 1996.
General
Authority:SDCL 34-24-25.
Law
Implemented:SDCL 34-24-21, 34-24-24.
Back to
44 |
44:19 