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[Utah Administrative Code Table of Contents]
[Title R398. Table of Contents]
R398-1-1 Purpose and Authority.
(1) The purpose of this rule is to facilitate early detection, prompt referral, early treatment, and prevention of mental retardation in infants with certain metabolic disorders.
(2) Authority for the Newborn Screening program and promulgation of rules to implement the program are found in Section 26-10-6.
R398-1-2 Definitions.
(1) "Abnormal test result" means a result that is outside of the normal range for a given test.
(2) "Appropriate specimen" means a blood specimen submitted on the Utah Newborn Screening Kit form which conforms with the criteria in R398-1-8.
(3) "Congenital Hypothyroidism" means a disorder in which the newborn is unable to secrete or produce thyroxine normally.
(4) "Department" means the Utah Department of Health.
(5) "Follow up" means the tracking of all newborns with an abnormal result, inconclusive result, inadequate specimen or a QNS specimen through to a normal result or confirmed diagnosis and referral.
(6) "Galactosemia" means a recessively inherited genetic disorder in which the individual is completely or partially incapable of normal metabolism of galactose due to a deficiency of the galactose-1-phosphate uridyltransferase enzyme.
(7) "Inadequate specimen" means a specimen determined by the Newborn Screening Laboratory to be unacceptable for testing.
(8) "Inconclusive result" means a specimen that has no growth on the Gutherie inhibition test for phenylketonuria.
(9) "Institution" means a hospital, alternate birthing facility, or midwife service in Utah which provides maternity or nursery services or both.
(10) "Metabolic diseases" means those diseases due to an inborn error of metabolism, for which the Department of Health shall screen all infants.
(11) "Newborn Screening Kit" means the department's demographic form with attached Food and Drug Administration (FDA)-approved filter paper medical collection device.
(12) "Phenylketonuria" means a recessively inherited genetic disorder in which the individual is completely or partially incapable of normal metabolism of phenylalanine due to a deficiency of the phenylalanine hydroxylase enzyme.
(13) "Practitioner" means a person licensed by the Department of Commerce, Division of Occupational and Professional Licensing to practice medicine, naturopathy, or chiropractic or to be a nurse practitioner, as well as the licensed or unlicensed midwife who takes responsibility for delivery or the health care of a newborn.
(14) "QNS specimen" means a specimen that has been partially tested but requires more blood to complete the full testing.
R398-1-3 Implementation.
Each newborn in the state of Utah shall submit to the Newborn Screening testing, except as provided in Section R398-1-11.
R398-1-4 Responsibility for Collection of the First Specimen.
(1) If the newborn is born in an institution, the institution must collect and submit an appropriate specimen, unless transferred to another institution prior to 48 hours of age.
(2) If the newborn is born outside of an institution, the practitioner or other person primarily responsible for providing assistance to the mother at the birth must arrange for the collection and submission of an appropriate specimen.
(3) If there is no other person in attendance of the birth, the parent or legal guardian must arrange for the collection and submission of an appropriate specimen.
(4) If the newborn is transferred to another institution prior to 48 hours of age, the receiving health institution must collect and submit an appropriate specimen.
R398-1-5 Timing of Collection of First Specimen.
The first specimen shall be collected between 48 hours and five days of age. Except:
(1) If the newborn is discharged from an institution before 48 hours of age, an appropriate specimen must be collected within four hours of discharge.
(2) If the newborn is to receive a blood transfusion or dialysis, the appropriate specimen must be collected immediately before the procedure, except in emergency situations where time does not allow for collection of the specimen. If the newborn receives a blood transfusion or dialysis prior to collecting the appropriate specimen the following must be done:
(a) Repeat the collection and submission of an appropriate specimen 7-10 days after last transfusion or dialysis for phenylketonuria and congenital hypothyroidism;
(b) Repeat the collection and submission of an appropriate specimen 120 days after last transfusion or dialysis for galactosemia.
R398-1-6 Parent Education.
The person who has responsibility under Section R398-1-4 shall inform the parent or legal guardian of the required collection and submission and the disorders screened. That person shall give the second half of the Newborn Screening Kit to the parent or legal guardian with instructions on how to arrange for collection and submission of the second specimen.
R398-1-7 The Second Specimen.
A second specimen shall be collected between 7 and 28 days of age.
(1) The parent or legal guardian shall arrange for the collection and submission of the appropriate specimen through an institution, practitioner, or local health department.
(2) If the newborn's first specimen was obtained prior to 48 hours of age, the second specimen shall be collected by fourteen days of age.
(3) If the newborn is hospitalized beyond the seventh day of life, the institution shall arrange for the collection and submission of the appropriate specimen.
R398-1-8 Criteria for Appropriate Specimen.
(1) The institution or practitioner collecting the appropriate specimen must:
(a) Use only a Newborn Screening Kit purchased from the department. The fee for the kit is set by the Legislature in accordance with Section 26-1-6 ;
(b) Correctly store the Newborn Screening Kit;
(c) Not use the Newborn Screening Kit beyond the date of expiration;
(d) Not alter the Newborn Screening Kit in any way;
(e) Complete all information on the Newborn Screening Kit. If the infant is being adopted, the following may be omitted: infant's last name, birth mother's name, address, and telephone number. Infant must have an identifying name, and a contact person must be listed;
(f) Apply sufficient blood to the filter paper;
(g) Not contaminate the filter paper with any foreign substance;
(h) Not tear, perforate, scratch, or wrinkle the filter paper;
(i) Apply blood evenly to one side of the filter paper and be sure it soaks through to the other side;
(j) Apply blood to the filter paper in a manner that does not cause caking;
(k) Collect the blood in such a way as to not cause serum or tissue fluids to separate from the blood;
(l) Dry the specimen properly;
(m) Not remove the filter paper from the Newborn Screening Kit.
(2) Submit the completed Newborn Screening Kit to the Utah Department of Health, Newborn Screening Laboratory, 46 North Medical Drive, Salt Lake City, Utah 84113.
(a) The Newborn Screening Kit shall be placed in an envelope large enough to accommodate it without folding the kit.
(b) If mailed, the Newborn Screening Kit shall be placed in the U.S. Postal system within 24 hours of the time the appropriate specimen was collected.
(c) If hand-delivered, the Newborn Screening Kit shall be delivered within 48 hours of the time the appropriate specimen was collected.
R398-1-9 Abnormal Result.
(1) If the department finds an abnormal result, the department shall inform the practitioner noted on the screening specimen form.
(2) The practitioner shall submit an appropriate specimen in accordance with Section R398-1-8. The specimen shall be collected and submitted within two days of notice, and the form shall be labeled for testing as directed by the department.
(3) The parent or legal guardian of a newborn identified with an abnormal test result shall promptly take the newborn to the practitioner to have an appropriate specimen collected.
(4) The department shall notify the practitioner of the test result. If the result is abnormal:
(a) The practitioner shall refer the newborn and family to the Newborn Screening Program within the department for confirmatory diagnostic services for phenylketonuria or galactosemia. The department shall pay for the diagnostic laboratory work that it orders.
(b) The department shall notify the practitioner of the need for confirmatory diagnostic services for congenital hypothyroidism. The department shall pay for the diagnostic laboratory work at a laboratory directed by the department.
(c) The practitioner shall complete a diagnostic form and return it to the department within 30 days.
R398-1-10 Inconclusive Result, Inadequate Specimen, or QNS Specimen.
(1) If the department finds an inconclusive result, inadequate specimen, or QNS specimen, the department shall inform the practitioner noted on the screening specimen form.
(2) The practitioner shall submit an appropriate specimen in accordance with Section R398-1-8. The specimen shall be collected and submitted within two days of notice, and the form shall be labeled for testing as directed by the department.
(3) The parent or legal guardian of a newborn identified with an inconclusive result, inadequate specimen or QNS specimen shall promptly take the newborn to the practitioner to have an appropriate specimen collected.
R398-1-11 Testing Refusal.
A parent or legal guardian may refuse to allow the required testing for religious reasons only. The practitioner or institution shall file in the newborn's record documentation of refusal, reason, education of family about the disorders, and signed waiver by a parent or legal guardian. The practitioner or institution shall submit a copy of the refusal to the Utah Department of Health, Family Health Services, Newborn Screening Program, P.O. Box 144660, Salt Lake City, UT 84114-4660.
R398-1-12 Access to Medical Records.
The department shall have access to the medical records of a newborn in order to identify practitioner, reason appropriate specimen was not collected, or to collect missing demographic information.
R398-1-13 Noncompliance by Parent or Legal Guardian.
If the practitioner or institution has information that leads it to believe that the parent or legal guardian is not complying with this rule, the practitioner or institution shall report such noncompliance as medical neglect to the department.
R398-1-14 Test Changes.
The department, after consulting with the Genetic Advisory Committee, may make additions or changes to the Newborn Screening battery of tests.
[Indexing]
KEY: health care, newborn screening
1994
[Editor's note: Below are references
to the Utah Code that are listed by the
agency making this rule as authority
for the rule.]
26-1-6
26-10-6
Notice of Continuation October 12, 1999
