New Born Screening Flashcards
Newborn Screening RA
No. 9288
SECTION 1. Short Title.
“Newborn Screening Act of 2004.”
SEC. 4. Definitions.
means a newborn screening system that includes, but is not limited to, education of relevant stakeholders; collection and biochemical screening of blood samples taken from newborns; tracking and confirmatory testing to ensure the accuracy of screening results; clinical evaluation and biochemical/medical confirmation of test results; drugs and medical/surgical management and dietary supplementation to address the heritable conditions; and evaluation activities to assess long term outcome, patient compliance and quality assurance.
Comprehensive Newborn Screening System
SEC. 4. Definitions.
condition means any condition that can result in mental retardation, physical deformity or death if left undetected and untreated and which is usually inherited from the genes of either or both biological parents of the newborn.
Heritable
NIH means
National Institute of Health
Newborn means a child from the time of complete delivery to ___days old
30
means the process of collecting a few drops of blood from the newborn onto an appropriate collection card and performing biochemical testing for determining if the newborn has a heritable condition.
Newborn Screening
means a facility equipped with a newborn screening laboratory that complies with the standards established by the NIH and provides all required laboratory tests and recall/follow-up programs for newborns with heritable conditions.
Newborn Screening Center
means the central facility at the NIH that defines testing and follow-up protocols, maintains an external laboratory proficiency testing program, oversees the national testing database and case registries, assists in training activities in all aspects of the program, oversees content of educational materials and acts as the Secretariat of the Advisory Committee on Newborn Screening.
Newborn Screening Reference Center
means the various means of providing parents or legal guardians information about newborn screening.
Parent education
means a procedure for locating a newborn with a possible heritable condition for purposes of providing the newborn with appropriate laboratory to confirm the diagnosis and, as appropriate, provide treatment.
Recall
means the provision of prompt, appropriate and adequate medicine, medical, and surgical management or dietary prescription to a newborn for purposes of treating or mitigating the adverse health consequences of the heritable condition.
Treatment
SEC. 6. Performance of Newborn Screening.
Newborn screening shall be performed after (__) hours of life but not later than (__) days from complete delivery of the newborn. A newborn that must be placed in intensive care in order to ensure survival may be exempted from the __-day requirement but must be tested by (__) days of age. It shall be the joint responsibility of the parent(s) and the practitioner or other person delivering the newborn to ensure that newborn screening is performed. An appropriate informational brochure for parents to assist in fulfilling this responsibility shall be made available by the Department of Health and shall be distributed to all health institutions and made available to any health practitioner requesting it for appropriate distribution.
24; 3; 3; 7
SEC. 11. Advisory Committee on Newborn Screening
The Committee shall be composed of (__) members, including the Secretary of Health who shall act as ________. The other members of the Committee shall be as follows: (i) the ______________ of the NIH, who shall act as Vice Chairperson; (ii) an Undersecretary of the ______; (iii) the Executive Director of the Council for the Welfare of Children (iv) the ________of the Newborn Screening Reference Center; and (v) (__) _______________appointed by the Secretary of Health who shall be a ____________, ____________, ____________, family physician, nurse or ________, from either the public or private sector. The (__) representatives shall be appointed for a term of (__) years, subject to their being reappointed for additional (__) years period for each extension.
8; Chairman; Executive Director; DILG; Director; 3; representatives; pediatrician; obstetrician; endocrinologist; midwife; 3; 3; 3
All Newborn Screening Centers shall coordinate with the NIH Newborn Screening Reference Center for consolidation of patient databases. The NIH Newborn Screening Reference Center shall maintain a national database of patients tested and a registry for each condition. It shall submit reports annually to the Committee and to the DOH on the status of and relevant health information derived from the database. A plan for long-term outcome evaluation of newborn screening utilizing the cases registries shall be developed within one (__) year of passage of this Act by the NIH Newborn Screening Reference Center in consultation with the Advisory Committee on Newborn Screening. Implementation of this plan shall become a responsibility of the Advisory Committee on Newborn Screening.
SEC. 15. Database
1
