12 2 STA T .70 7 PUBLIC LA W 110 – 20 4— AP R .24 , 200 8(B)inpar a g rap h ( 2 ) ,byst ri k ing ‘ ‘an d’ ’a f t e rthese m i -col on
( C ) by inserting after paragraph (2) the follo w ing
‘‘( 3 ) make systematic e v idence-based and peer-reviewed rec- ommendations that incl u de the heritable disorders that have the potential to significantly impact public health for which all newborns should be screened, including secondary conditions that may be identified as a result of the laboratory methods used for screening; ‘‘( 4 ) develop a model decision-matri x for newborn screening expansion, including an evaluation of the potential public health impact of such expansion, and periodically update the rec- ommended uniform screening panel, as appropriate, based on such decision-matrix; ‘‘( 5 ) consider ways to ensure that all S tates attain the capacity to screen for the conditions described in paragraph (3), and include in such consideration the results of grant funding under section 1 1 09
- and’’;
( D ) in paragraph ( 6 ) (as so redesignated by subpara- graph ( A )), by striking the period at the end and inserting ‘‘, which may include recommendations, advice, or informa- tion dealing with — ‘‘(A) follow-up activities, including those necessary to achieve rapid diagnosis in the short-term, and those that ascertain long-term case management outcomes and appro- priate access to related services; ‘‘(B) implementation, monitoring, and evaluation of newborn screening activities, including diagnosis, screening, follow-up, and treatment activities; ‘‘(C) diagnostic and other technology used in screening; ‘‘(D) the availability and reporting of testing for condi- tions for which there is no existing treatment; ‘‘( E ) conditions not included in the recommended uni- form screening panel that are treatable with F ood and Drug Administration-approved products or other safe and effective treatments, as determined by scientific evidence and peer review; ‘‘(F) minimum standards and related policies and proce- dures used by State newborn screening programs, such as language and terminology used by State newborn screening programs to include standardi z ation of case definitions and names of disorders for which newborn screening tests are performed; ‘‘( G ) q uality assurance, oversight, and evaluation of State newborn screening programs, including ensuring that tests and technologies used by each State meet established standards for detecting and reporting positive screening results; ‘‘( H ) public and provider awareness and education; ‘‘( I ) the cost and effectiveness of newborn screening and medical evaluation systems and intervention programs conducted by State-based programs; ‘‘( J ) identification of the causes of, public health impacts of, and risk factors for heritable disorders; and ‘‘( K ) coordination of surveillance activities, including standardized data collection and reporting, harmonization of laboratory definitions for heritable disorders and testing
�
