Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 270.000 - Blood Screening Of Newborns For Treatable Diseases And Disorders › Section 270.004 - Definitions

Current through Register 1525, July 5, 2024
Department
means the Massachusetts
				Department of Public Health or its designated agent.
Diagnostic Evaluation
means the
				clinical evaluation of an individual or the laboratory testing of a clinical
				specimen from an individual with signs or symptoms or screening indicators of a
				disease or disorder in order to confirm or rule out the disease or disorder in
				that individual.
Health Care Provider
means the current
				primary care or other current physician for a person. Health Care Provider
				shall also include Advanced Practice Registered Nurses, duly licensed and
				registered to engage in advanced practice nursing activities by the
				Massachusetts Board of Registration in Nursing, and Physician Assistants, duly
				licensed and registered to practice as a physician assistant by the
				Massachusetts Board of Registration of Physician Assistants, who are currently
				providing care to a person.
Health Care Provider Attending a
				Newborn
means the Director of Newborn Medicine or other treating
				physician designated by the hospital of birth/neonatal care unit to care for
				the newborn, or the physician who certifies the birth of the newborn. Health
				Care Provider Attending a Newborn shall also include Advanced Practice
				Registered Nurses, duly licensed and registered to engage in advanced practice
				nursing activities by the Massachusetts Board of Registration in Nursing, and
				Physician Assistants, duly licensed and registered to practice as a physician
				assistant by the Massachusetts Board of Registration of Physician Assistants,
				who care for the newborn.
Infant
means any liveborn person who
				has yet to have had a first year birthday.
Mandated Newborn Blood Screening
means
				the required statewide collection and testing of newborn/infant blood specimens
				from all newborns/infants in Massachusetts and related follow up activities for
				the benefit of the child tested (subject to religions exemption only) for
				diseases and disorders for which:
(1) there is a significant, life-challenging risk of morbidity
				or mortality to those who have the disease or disorder if they are not treated
				in the newborn/infant period;
(2) a standard of care screening test is universally
				available;
(3) a standard of care diagnostic evaluation is universally
				available for all newborns/infants whose newborn screening results warrant
				such;
(4) a standard of care treatment for the screened
				newborn/infant is universally available;
(5) a standard of care treatment in the newborn/infant period
				is beneficial to the screened newborn with a confirmed diagnosis;
(6) resources for and access to treatment and counseling are
				available; and
(7) the positive health benefits outweigh the risks and burdens
				of screening and treatment.
Newborn
means any liveborn infant who
				has not yet attained the age of 31 days from a birth occurring in the
				Commonwealth of Massachusetts or from a birth prior to transfer to a hospital
				in the Commonwealth of Massachusetts.
Newborn Blood Screening Program
means
				the program operated either by the Department or its agent to conduct Mandated
				and Optional Newborn Blood Screening for the Commonwealth's newborns.
Optional Newborn Blood Screening
				Program
means the universal offering of one or more Pilot Studies
				to the newborn population.
Pilot Study
means a research protocol
				with an informed consent process approved by the Department's Institutional
				Review Board that includes statewide testing of newborn blood specimens and
				related follow up activities offered for those diseases and disorders that do
				not meet the criteria for Mandated Newborn Screening but are likely, based on
				an evaluation of additional information to be gained through the pilot study,
				to have the potential to meet the criteria for mandatory screening and provide
				a benefit to newborns. Pilot studies provide for the maintenance of specimen
				identifiers, allowing study results to be linked to, and reported for, specific
				individuals.
Residual Specimen
means any dried
				blood spot collected in accordance with
				105 CMR 270.000 or
				derivative specimen that remains following the completion of newborn blood
				screening and any necessary follow-up for the benefit of the child
				tested.
Screening Tests
means the laboratory
				testing of clinical specimens from a population of individuals regardless of
				health status to detect markers or risk factors of a disease or a
				disorder.
Specimen
means a blood sample
				collected according to Newborn Blood Screening Program guidelines on the filter
				paper that is provided by the Newborn Blood Screening Program.