Texas Administrative Code
Title 25 - HEALTH SERVICES
Part 1 - DEPARTMENT OF STATE HEALTH SERVICES
Chapter 37 - MATERNAL AND INFANT HEALTH SERVICES
Subchapter D - NEWBORN SCREENING PROGRAM
Section 37.55 - Newborn Screening Specimen Collection Kits
Universal Citation: 25 TX Admin Code ยง 37.55
Current through Reg. 49, No. 38; September 20, 2024
(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.
Disclaimer: These regulations may not be the most recent version. Texas 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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