28 Pa. Code § 28.1
The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:
Abnormal confirmatory test result-A test result obtained from a specimen of blood, serum or plasma which is diagnostic of the newborn disease under investigation.
Abnormal screening test result-A test result obtained from a specimen collected on a specimen collection form which is outside the parameters for a normal test result according to testing criteria applicable to the screening test result.
Admission-The formal acceptance of custody or care by a birth center or hospital of a newborn child who is provided with bassinet or incubator, nutrition and continuous nursing service.
Birth center-As defined in section 802a of the Health Care Facilities Act (35 P. S. § 448.802a).
Days of age-The measurement of age of the newborn child in 24-hour periods so that a newborn child is one day of age 24 hours after the hour of birth.
Department-The Department of Health of the Commonwealth.
Discharge-The release of the newborn child from care and custody within and by birth center or hospital to the care and custody of the parent or guardian.
Health care practitioner-A licensed physician or a practitioner licensed to deliver and care for pregnant women and newborn children.
Health care provider-A birth center, hospital or health care practitioner.
Hemoglobin diseases-Sickle cell (SS, SC, S + other variant, S [BETA] Thalassemia, S O Arab) disease or trait or other clinically significant hemoglobin (CC, EE, F, H) disease or trait.
Hospital-As defined in section 802a of the Health Care Facilities Act.
Inconclusive screening test result-A test result obtained from a specimen collected on a specimen collection form that is equivocal according to criteria applicable to the screening test result and which indicates the need for a repeat specimen and repeat testing.
Initial specimen-The first sample of blood collected from the newborn child and submitted for testing purposes on a specimen collection form.
Newborn child-An infant less than 28 days of age.
Newborn screening program-The association of the Department, the testing laboratory and the health care provider to ensure that every newborn child born in this Commonwealth has a blood specimen collected and screened for the newborn diseases in § 28.2 (relating to newborn diseases listed).
Presumptive abnormal test result-An abnormal screening test result which is sufficiently abnormal to indicate the probable presence of a newborn disease listed in § 28.2.
Repeat specimen-A specimen collected from a newborn child on a specimen collection form after the initial specimen.
Repeat test-The laboratory testing performed on a repeat specimen.
Specimen collection form-The official newborn screening program specimen form that includes both a multipart section for providing required information about the newborn child and a filter paper tab for application of blood.
Testing laboratory-The licensed clinical laboratory under contract with the Department to perform testing for the newborn diseases listed in § 28.2.
Transfer-The release of the newborn child from care and custody within and by a birth center or hospital and subsequent admission to another hospital.
Treatment center-A center under contract with the Department to provide expert consultation, diagnosis and treatment for children with a presumptive abnormal test result.
Unacceptable specimen-A blood specimen collected from a newborn child on a specimen collection form which is found to be unsuitable for testing in accordance with accepted laboratory testing standards as determined by the Department.
28 Pa. Code § 28.1
The provisions of this § 28.1 amended under section 16(a) of the Disease Control and Prevention Act of 1955 (35 P. S. § 521.16(a)); sections 2102(g) and 2111(b) of The Administrative Code of 1929 (71 P. S. §§ 532(g) and 541(b)); and sections 3 and 5 of the Newborn Child Testing Act (35 P. S. §§ 623 and 625).