| (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.
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