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RULE §37.51Purpose

(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 exceptions:

  (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 is Performed).

(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).

Source Note: The provisions of this §37.51 adopted to be effective November 1, 2006, 31 TexReg 8835; amended to be effective December 31, 2013, 38 TexReg 9567

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