|(a) Newborn screening is composed of screening performed
on blood specimens ("blood spot-based newborn screening") as well
as that performed at the point-of-care ("point-of-care newborn screening").
This subchapter covers blood spot-based newborn screening, with two
(1) program benefits (§37.60 of this title relating
to Newborn Screening Program Benefits); §37.61(a)(1) of this
title (relating to Eligibility Requirements for the Newborn Screening
Program Benefits); §37.63(a)(1) of this title (relating to Denial
of Application, and Modification, Suspension, or Termination of Newborn
Screening Program Benefits); and
(2) Newborn Screening Advisory Committee (§37.64
of this title (relating to Newborn Screening Advisory Committee)).
Point-of-care newborn screening tests are structured to be covered
in a separate rule subchapter under this chapter. For purposes of
this subchapter, references to the "Newborn Screening Program" (program)
means newborn screening that is blood spot-based. This subchapter
implements Texas Health and Safety Code, Chapter 33, administered
by the Texas Department of State Health Services (department), except
for the requirements associated with conducting Critical Congenital
Heart Disease (CCHD) screening, which will be implemented in a separate
subchapter. Each newborn delivered in the state must be screened,
which involves two blood draws collected on separate days, as described
in this subchapter, followed by department laboratory screening tests
on those blood specimens for phenylketonuria, other heritable diseases,
hypothyroidism, and certain other disorders as detailed in §37.53
of this title (relating to Disorders for Which Blood Specimen Screening
(b) This subchapter also details legal requirements
applicable to physicians (or other persons attending a newborn, if
no physician is present).
(c) Specimen collection kits are obtained from the
department as referenced in this subchapter. Screening results are
reported by the department as provided by law. A screen may produce
false positive or false negative results, and should not be relied
upon as diagnostic. For this reason, the department strongly recommends
that the child be placed under the care of a licensed physician with
appropriate expertise for diagnosis and treatment.
(d) This subchapter also details follow-up, reporting,
and record keeping on abnormal screening results and confirmed cases.
(e) This subchapter also identifies program services
which are available to individuals who have an abnormal screening
result (pending confirmation of diagnosis), or a confirmed diagnosis
of a disorder referenced in this subchapter. Additionally, this subchapter
establishes eligibility criteria, financial participation requirements
and procedures for the orderly provision of the identified services
to eligible individuals, subject to §37.61 of this title (relating
to Eligibility Requirements for the Newborn Screening Program Benefits).