Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 28 - SCREENING AND FOLLOW-UP FOR DISEASES OF THE NEWBORN › GENERAL PROVISIONS › Section 28.1 - Definitions

Current through Register Vol. 54, No. 28, July 13, 2024
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.
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).