Section 28.1. Definitions

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 ß 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.

The provisions of this § 28.1 amended May 17, 2002, effective May 18, 2002, 32 Pa.B. 2435. Immediately preceding text appears at serial pages (287186) and (240177).

Notation

Authority

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).