25 Tex. Admin. Code § 37.55 - Newborn Screening Specimen Collection Kits

(a) Purpose. This section establishes procedures for the obtaining, and subsequent submission of, newborn screening specimen collection kits provided by the department.

(b) Specimen collection kits.

(1) The requestor will estimate and submit to the department a written order, using forms designated by the department, for newborn screening specimen collection kits. The estimate should be based on the requestor's previous usage. A requestor shall provide further information to the department, upon request, to verify the appropriateness of the number of specimen collection kits ordered.

(A) The department will provide specimen collection kits for Medicaid-eligible, CHIP-eligible, or charity care newborns at no cost. The no-cost specimen collection kit should only be used for a Medicaid-eligible, CHIP-eligible or charity care newborn, and the submitter must affirm this on the specimen collection kit request form.

(B) The department will provide specimen collection kits for all other newborns at a fee described in §73.54(a)(1)(A)(i) of this title (relating to Fee Schedule for Clinical Testing and Newborn Screening).

(2) The department reserves the right to adjust the quantity of kits provided for an order based on factors such as the requestor's past orders, submission rates, and the availability of kits.

(3) The department will bill the requestor for specimen collection kits. Payment is due within 90 days from the statement date.

(4) The department will accept only its approved specimen collection kits for submission of specimens.

(5) Each time newborn screening samples are collected from the child, the physician (or other person attending a newborn, if no physician is present) shall ensure that the parent, managing conservator, or legal guardian is given the department's information on newborn screening, including the Texas Newborn Screening Parent Information form, and the Parental Decision for Storage and Use of Newborn Screening Blood Spot Cards form. The physician (or other person attending a newborn, if no physician is present) shall verify the information was distributed to the parent, managing conservator, or legal guardian by checking the appropriate box on the demographic information sheet, which must be included with the blood specimen when the kit is submitted to the department for testing. The physician (or other person attending a newborn, if no physician is present) must also include the signed Parental Decision for Storage and Use of Newborn Screening Blood Spot Cards form, if the parent signs the form at that time. If the signed form is presented to the physician (or other person attending a newborn, if no physician is present) at any other time, it must be submitted to the department at that time. The physician attending a newborn child may delegate the responsibilities in this section to any qualified and properly trained person acting under the physician's supervision.

(6) Returned specimen collection kits: if the purchaser believes a kit(s) is defective, purchaser should immediately contact the department's laboratory in Austin. Kit(s) which are verified to be defective by the department can be returned for credit for future kit orders, as directed by the department.

Notes

25 Tex. Admin. Code § 37.55

The provisions of this §37.55 adopted to be effective December 31, 2013, 38 TexReg 9567