Arkansas Administrative Code
Agency 007 - Arkansas Department of Health
Division 19 - Public Health Laboratory
Rule 007.19.23-001 - Rules Pertaining to the Testing of Newborn Infants
Universal Citation: AR Admin Rules 007.19.23-001
Current through Register Vol. 49, No. 9, September, 2024
SECTION I. DEFINITIONS.
A. The Collector is the person
or party responsible for collecting and submitting the blood specimen for
testing. The persons or parties who are collectors under these Rules are
described in SECTION IV.A.
B.
Recommended uniform screening panel (RUSP) is a list of medical
conditions that the Secretary of the Department of Health and Human Services
(HHS) recommends for states to screen as part of their state NBS programs.
Although states ultimately determine what medical conditions their NBS programs
will screen for, the RUSP establishes a standardized list of medical conditions
that have been supported by the Advisory Committee on Heritable Disorders in
Newborns and Children and recommended by the Secretary of HHS. Medical
conditions on the RUSP are chosen based on evidence that supports the potential
net benefit of screening, the ability of states to screen for the condition,
and the availability of effective treatments. Medical conditions included on
the RUSP are designated as Core Conditions or Secondary Conditions.
C.
Universal newborn screening program
(NBS) is a public health intervention program with the goal of
supporting early diagnosis, treatment, and services for many life-threatening
genetic illnesses before any symptoms begin to enable healthy development and
prevention of disability or morbidity.
SECTION II. PURPOSE.
The purpose of these Rules is to assure that all infants born in Arkansas have the opportunity to be screened for the core medical conditions as listed in the RUSP.
A. These Rules
provide a method to assure that:
1. All
newborn infants are screened for core medical conditions included in the
RUSP.
2. All newborns with abnormal
screening results shall receive appropriate medical follow-up.
SECTION III. AUTHORITY.
These Rules are promulgated pursuant to the authority conferred by Arkansas Code Annotated § 20-15-301, et seq., as amended by Act 490 of 2023.
SECTION IV. RESPONSIBILITY.
A. Collection and
Submission.
1. Medical Facilities/Medical
Staff: In all cases where the birth of an infant occurs in a medical facility
licensed by the State Board of Health, it shall be the responsibility of the
governing body and medical staff of the facility to adopt and enforce policies
and procedures which ensures that blood test for core medical conditions as
listed in the RUSP are conducted and processed in accordance with these rules.
The licensed facility shall also be responsible for submission of the usable
blood specimen in cases where an infant less than six months of age is admitted
(i.e., born out of hospital, neonatal transfer, etc.), and it is brought to the
attention of the facility or the attending physician that the infant is
untested. If an infant is discharged from a licensed medical facility without
collection and submission of a usable specimen for testing, it shall be the
responsibility of the discharging facility and the attending physician to
arrange for the testing. The discharging facility and attending physician shall
notify the Department of Health within one week of discharge if their efforts
fail to arrange for testing.
2.
Physicians: Physicians assuming care of infants who are under six months of age
and who come to their attention as being untested or inadequately tested for
core medical conditions as listed in the RUSP, shall also be responsible for
assuring collection and submission of usable blood specimens for these
infants.
3. Licensed Midwives: In
cases where the birth occurs outside a licensed medical facility or in the
home, it shall be the responsibility of an attending licensed midwife to advise
the parents of this law and the procedure for conducting newborn screening, and
documenting that a blood sample is obtained after 24 hours and no later than 72
hours after birth. If the blood sample is not obtained for any reason, an
attending licensed midwife must document the incident in the patient's
chart.
4. The Department of Health:
The Department of Health's Local Health Unit shall collect and submit usable
blood specimens on all infants under six months of age who come to their
attention as being tested or inadequately tested. This responsibility shall not
be in lieu of that of the preceding individuals and facilities.
B. Payment
1. The Collector will be charged a fee of one
hundred and thirty-one dollars ($131.00) for the processing and testing of
newborn screening specimens by the Department of Health.
2. The State Board of Health may determine
the amount of this fee based on the Department's cost to process and test the
specimens.
C. Laboratory
Analysis
1. The Department shall be
responsible for provision of forms and instructions for the blood specimen
collection; processing and recording of the specimen received; analysis of
specimen; determination of abnormal results; and reporting of lab results
within a time period which would allow preventive medical intervention. Testing
for core medical conditions newly added to the RUSP shall begin within
thirty-six (36) months upon introduction to the RUSP.
D. Follow-Up
1. The Department of Health shall be
responsible for the interpretation of laboratory results and the reporting of
abnormal results to the attending physician or birth attendant. If the
screening result is suggestive of a core medical condition as listed on the
RUSP, the Department shall consult with specialist physicians. The Department
shall notify the Collector of the specimen and enter the infant's information
in a tracking system maintained to evaluate program operations and infants'
medical outcomes.
2. Attending
Physician/Medical Attendant:
(a) Upon receipt
of a notice of an abnormal test result the physician or medical attendant shall
be responsible for the appropriate medical treatment, referral, and/or
retesting within the timeframe specified by the Department for that condition.
It is strongly recommended that consultation be obtained with a physician who
has special competence in the management of these conditions.
(b) The attending physician or other
responsible health care provider who conducts testing in follow-up to abnormal
screens shall report subsequent test results (whether negative or positive) to
the Department. To provide for long term follow up the Department will collect
data on affected infants each year for five years to determining health care
maintenance and health status, especially the presence of mental retardation or
permanent disability.
The Department will establish protocols for follow-up of all screened conditions in collaboration with medical specialists. For infants with abnormal test results, the physician will be notified of the results and informed of the recommended protocols for follow-up of the conditions.
SECTION V. SPECIMEN COLLECTION AND SUBMISSION
A. The blood specimen for core medical
conditions as listed in the RUSP screening must be collected and submitted as
described below:
B. Timing of
Specimen Collection
1. For all healthy infants
born in medical facilities, the specimen shall be collected before the time of
discharge from the facility. Optimum time for collection is 24 to 72 hours
after birth, and all Collectors should strive to comply with that time frame.
If any infant is discharged or specimen collected prior to 24 hours of age, a
repeat test shall be arranged by the medical facility and the attending
physician. This repeat specimen shall be collected by the infant's seventh day
of life. A repeat test for Sickle Cell Disease shall not be required if
specimen was collected prior to 24 hours of age.
2. Specimens from ill or premature infants
shall be obtained as soon as possible after their condition has sufficiently
stabilized.
3. Specimens from
infants not born in medical facilities shall be collected between 24 and 72
hours after birth.
Infants under six months of age who are known to be untested or inadequately tested shall have blood specimens collected and submitted by the responsible authority as soon as possible.
C. Specimen Collection and Submission
1. Specimens shall be dispatched to the
Arkansas Department of Health Public Health Laboratories, Little Rock,
Arkansas, no later than one (1) business day from collection. Specimens are
submitted only on forms provided by the Public Health Laboratory. The Collector
is responsible for supplying complete and accurate identifying information on
the collection form to be used for tracking infants with abnormal screening
results.
D. Forms
1. Submission: Forms may be obtained by
writing to the Public Health Laboratory at:
Arkansas Department of Health
Public Health Laboratory
201 South Monroe Street
Little Rock, AR 72205
The county health units will not supply these forms.
E. Unsatisfactory
Specimens
1. Inadequate, contaminated, or
otherwise unusable specimens shall be reported to the Collector after
laboratory determination of an unsatisfactory specimen. The Collector shall be
responsible for assuring recollection and resubmission within seven calendar
days of notification.
SECTION VI. ANALYSIS, INTERPRETATION, AND REPORTING OF RESULTS
A. Laboratory
Analysis
1. All specimens received by the
laboratory shall be initially examined within five working days of receipt.
Abnormal results shall be reported to the Collector within two working days of
determination.
B.
Interpretations of Results
1. The Department
of Health, in collaboration with consulting medical specialists providing
clinical advice on core medical conditions, shall define the levels which
constitute positive screening results for each core medical condition listed in
the RUSP and included in the Arkansas NBS screening panel.
2. The medical caretaker shall give special
consideration to retesting any infant whose case findings, testing
circumstances, or family history seems to medically warrant it.
C. Reporting of Results
1. Immediately upon obtaining the initial
positive screening result, the Department of Health shall notify the attending
physician or medical attendant, who shall be responsible for ensuring that
prompt follow-up diagnostic testing is conducted.
2. Appropriate, expectant medical management
shall not be withheld pending the confirmatory test results. A non-physician
Collector shall immediately refer the infant for appropriate medical
intervention. It is recommended that a pediatric geneticist, endocrinologist,
pulmonologist, or other appropriate specialist consultant, depending on the
medical condition, be utilized in the management of these infants.
SECTION VII. ARKANSAS DEPARTMENT OF HEALTH ROLE IN TREATMENT AND MONITORING
A. Listing of Consultants
1. For core medical conditions, as listed on
the RUSP, the Department of Health shall maintain a list of pediatric
consultants having special competence in these disorders, and shall make the
names of such consultants known to the attending physicians of infants with
abnormal screening test results.
B. Registry
1. For core medical conditions, as listed on
the RUSP, the Department of Health shall maintain a registry to record
laboratory results and diagnoses of all tested infants, and to track referral
for those infants in whom abnormal findings were noted during the screening
process.
C. Nutritional
Therapy
1. Phenylketonuria (PKU)
Nutritional therapy with low phenylalanine formula and/or foods shall be instituted after the diagnosis of PKU.
2. Galactosemia
Nutritional therapy with lactose-free formula and/or foods shall be instituted after the diagnosis of Galactosemia.
3. Other genetic conditions
Other genetic conditions discovered by the laboratory testing done pursuant to these regulations may require nutritional therapy as recommended by specialist consultants.
SECTION VIII. SEVERABILITY
If any provision of these Rules, or application thereof to any person or circumstance is held invalid, such invalidity shall not affect other provisions or applications of these Rules which give effect without the invalid provisions or applications, and to this end the provisions here to are declared to be severable.
SECTION IX. REPEAL
All Rules and parts of Rules in conflict here with are hereby repealed.
CERTIFICATION
This will certify the foregoing Rules Pertaining to Newborn Screening were adopted by the Arkansas State Board of Health at a regular session of the Board held in Arkansas on the 27th day of July, 2023. The effective date of this rule shall 10th day of February, 2024.
Disclaimer: These regulations may not be the most recent version. Arkansas may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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