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
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.
