|(a) A physician (or other person attending a newborn,
if no physician is present) shall obtain a capillary blood specimen
from the newborn and submit those specimens, all in accordance with
instructions in §37.55 of this title (relating to Newborn Screening
Specimen Collection Kits) and further instructions provided on and
with the specimen collection.
(b) A capillary blood specimen shall be collected by
absorbing the blood onto target circles on a specialized filter paper
collection device. Other body fluids or blood from the placenta, umbilical
cord, or mother are not acceptable.
(c) The blood specimen is to be obtained by the physician
(or other person attending the newborn, if no physician is present)
after 24 hours of age and before 48 hours of age. If the newborn is
discharged from the hospital or birthing facility before the above
criteria are met, the blood specimen must be obtained immediately
prior to discharge. A second blood specimen is to be collected between
one and two weeks of age in accordance with this section.
(1) If program data and/or other available information
demonstrate to the department's satisfaction that the second screening
is no longer necessary, the commissioner may remove the second screening
from the Texas Newborn Screening Program.
(2) The commissioner's decision would be announced
through means deemed appropriate by the commissioner to notify physicians,
other health care practitioners, and other interested persons. Prior
to the effective date of the announced change, the department's newborn
screening educational information will be revised to reflect this
(d) A repeat blood specimen shall be obtained as instructed
by the program to verify results, or if the initial blood specimen
(e) Transfusions can cause invalid results. The first
screening should be collected prior to the first transfusion, if possible.
(1) If collected prior to the transfusion, specimen
collection should proceed as described in subsection (c) of this section;
(2) If not collected prior to transfusion, a total
of three specimens should be obtained. The first and second screen
should be obtained as referenced in subsection (c) of this section.
The third specimen should be collected 90 days after the date of transfusion.
(f) Blood specimens must air-dry on a flat surface
for at least four hours and must be mailed to the department within
24 hours after collection. Directions for handling blood specimens
must be strictly followed to avoid cross-contamination.
(g) A physician (or other person attending a newborn,
if no physician is present), shall ensure that:
(1) the identifying and demographic information sheet
is complete and accurate when submitted to the department;
(2) identifying information shall include contact information
for the newborn's physician or health care practitioner to ensure
ability to contact the physician or health care practitioner in case
of abnormal screening results;
(3) parents receive the Texas Newborn Screening Parent
Information form, and the Parental Decision for Storage and Use of
Newborn Screening Blood Spot Cards form;
(4) the box on the patient demographic information
form is checked, and verifying information and decision forms were
provided to a parent, managing conservator, or legal guardian; and
(5) the Parental Decision for Storage and Use of Newborn
Screening Blood Spot Cards form is promptly sent to the department
upon being signed, and received from a parent, managing conservator,
or legal guardian.