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RULE §37.56Responsibilities of the Physician (or Other Person Attending a Newborn, if No Physician is Present) and Collection of First and Second Specimen

(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 program change.

(d) A repeat blood specimen shall be obtained as instructed by the program to verify results, or if the initial blood specimen was unsatisfactory.

(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.

Source Note: The provisions of this §37.56 adopted to be effective December 31, 2013, 38 TexReg 9567

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