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Responsibility for collection of screening specimens
(a) Either a non-physician attending the delivery of a newborn or any physician or health care practitioner attending a newborn within the first 30 days of life after delivery shall cause the screens to be performed according to these sections. When the baby is an inpatient in the hospital, the hospital shall ensure that the appropriate screens are done. When the baby is not in the hospital, the physician or health care practitioner who attends the newborn outside of the hospital shall be responsible for causing the appropriate screens to be done.[TAC 25 §37.55(a)]
(a) ….A second blood specimen is to be collected between one and two weeks of age by the newborn's physician or health care practitioner in accordance with §37.55 of this title….[TAC 25 §37.56(a)]
Timing of screening
State rules require that the first newborn screening test be collected between 24 - 48 hours of age or before hospital discharge. However, if the baby is discharged from the hospital before 24 hours of age, the first screen should be collected prior to discharge. Discharging an infant without collecting a specimen can result in no screen being collected and possibly missing an infant with one of the conditions.
The transferring facility must collect the newborn screening specimen before transfer unless the baby is so unstable that it cannot be done safely. If the screen is not collected before transfer, the transferring facility must ensure the next facility is aware of the need for screening.
If an infant is to receive a transfusion, a specimen should be collected prior to transfusion since even small transfusions may invalidate newborn screening results. A second specimen should be collected as usual at age 1-2 weeks. If the infant was not screened prior to transfusion, a third specimen should be collected 3 months post transfusion or at the time when red blood cells can be presumed to be of host origin.
Premature infants may have persistent abnormalities in newborn screening test results without having an abnormal condition. Some are born with gastrointestinal systems that are too immature to absorb nutrients safely and therefore receive their initial nutrients through intravenous (IV) feeding which is called total parenteral nutrition (TPN). Prematurity may be associated with physiological elevation of 17-hydroxyprogesterone and reduction of thyroxine. Amino acids (e.g. phenylalanine) may be elevated in infants on TPN. A premature infant with abnormal screening results should be re-screened at the time of discharge or when requested by the NBS program (whichever comes first). Physical or metabolic signs suggestive of the presence of a screened condition should prompt appropriate diagnostic testing for the suspected disorder immediately.
Second test required
The second newborn screening test should be collected on every infant at one to two weeks of age. Even the older infant who appears to be growing and developing normally may be identified with one of the conditions included in screening and thus if the screening has not been done it can be done up to a year of age. Although not legally mandated, infants moving to Texas who have not been screened should be tested if their screening results are not known.
Abnormal results are communicated to the department’s clinical care coordination staff to assure appropriate follow-up. Reports of screening results and notice of unsatisfactory specimens are mailed, faxed or electronically transmitted to the submitter usually within 7 days of receiving the specimen.
Specimen Collection Form
Complete the required information on the specimen collection card using a blue or black ball point pen only. Print carefully using block capital letters and stay within the prescribed limits of the computer intake boxes. Do not touch the filter paper blood collection circles while recording the information. Failure to complete the information requested may cause the tests not to be performed. This information is vital for identification and location of infants for follow-up of abnormal test results; it must be accurate, legible, and complete.
Collection kits include a parent copy that birthing facilities should complete and give to the parent. Explain to the parent that the form should be taken to the baby’s next office visit, will help link the child’s first and second screen, and will allow for quick notification of a disorder. The physician performing the second screen should review the parent copy and write the serial number in the designated area on the second screen kit. The first screen can also be linked with the second screen using the baby's surname, mother's first name, and date of birth. This linking of first and second screens may not occur if this information is recorded erroneously on the specimen collection form, or if the surname is changed after the first specimen is submitted. Mother's maiden name is also required for additional verification of linkage.
There are also fields on the specimen collection kit for information on the primary care physician who will be caring for the child. The additional PCP contact information is important to assist clinical care coordination staff in locating children with a possible disorder.
Gloves should be worn for personal safety. Care should be taken to avoid contamination of blood collection circles with antiseptic solutions, powders, lotions or other materials which may adversely affect the testing process. A videotape and written standard describing proper collection procedures is available for loan from the Biochemistry and Genetics Branch, Laboratory Services Section (call 512-458-7333 or 1-888-963-7111 x 7333) or may be purchased from the Clinical Laboratory Standards Institute (CLSI). A descriptive poster illustrating proper blood collection procedure is also available from the Biochemistry and Genetics Branch.
The Newborn Screening Program receives some blood spot specimens in a condition unacceptable for testing. Collection of a satisfactory specimen is the responsibility of the physician or healthcare practitioner attending the delivery of a newborn, or for the second screen, the physician, or health care practitioner attending a newborn within the first 30 days of life. Certain types of specimens are known to give invalid results including old specimens, those with incompletely filled, abraded, discolored, diluted or clotted spots, and those showing serum "rings". In these cases the newborn screening report will state "UNSATISFACTORY - PLEASE RESUBMIT". Submitting invalid specimens results in the inconvenience of retesting and delays the screening of the newborn, placing the newborn at risk for delayed diagnosis of a screened condition. IN CASES OF UNSATISFACTORY RESULTS, THE INFANT MUST BE RE-SCREENED AS SOON AS POSSIBLE (even if only one test is reported unsatisfactory). All submitters will receive periodic reports which provide information on the number of specimens submitted and statistics on specimen quality and transit times.
Refusal of Screening
Newborn screening is mandated by Texas law. Refusal is only legally permissible if the screening conflicts with the parent’s or legal guardian’s religious tenets or practices per Texas Health & Safety Code Sec. 33.012.
If a parent objects to testing based on religious grounds, the healthcare provider is to inform the parent of the consequences of refusal.
Points to cover include:
- An infant with one of these conditions who is not screened, diagnosed, and treated early can have serious complications, including growth problems, developmental delays, deafness, blindness, intellectual disabilities, seizures, and early death.
- Symptoms of a newborn screening disorder can appear much later, after a child’s health has already been severely affected.
- Most individuals diagnosed with these conditions do not have a family history of the disorder.
- Newborn screening is mandated by Texas law.
- The only legal reason for refusal of newborn screening is if it conflicts with the parent/legal guardian/managing conservator’s religious tenets or practice.
If a parent still wishes to refuse the newborn screen, require that they complete a statement indicating their declination of newborn screening. A NBS refusal form developed by the department can be found at the links below:
RELIGIOUS OBJECTION TO NEWBORN SCREENING TEST
The physician, midwife, person attending the delivery, or the child’s healthcare provider should retain the signed refusal form in the child’s medical record.