Pilot testing occurs after testing is approved by health Secretary. All specimens tested. Test can be added or discontinued after 5 years.
Designated subcommittee of umbrella advisory committee reviews proposed changes and makes recommendation. If umbrella committee approves, the proposal is sent to the health Secretary for approval. New conditions are reviewed after five years to determine whether to continue screening.
No consent required.
After validation/verification, specimens are analyzed in a semi-blinded fashion. Normal results are not reported. Abnormal results are given to a consultant (medical doctor) who informs the primary care provider.
University of Wisconsin IRB.
State Comments:
Although there have been exceptions (mutation analysis) the use of residual DBS specimens for method development/research etc happens within the first couple of weeks of storage to minimize any potential changes in the analyte being measured.
Pilot testing is not required but is conducted for validation.
It is up to the Office of Maternal, Child, and Family Health.
• National guidelines or recommendations.
No consent required.
Results returned based on decision of program.
Participation would require approval of maternal and child health program.
Email: [email protected]
Follow-up Coordinator:
Email: [email protected]
Previous conditions added to the panel have been piloted elsewhere.
Change to regulations, after public hearing, is required. Advisory committee evaluates condition using established criteria.
• Is the condition serious?
• Is safe, effective treatment available?
• Is early, presymptomatic intervention crucial for a satisfactory outcome?
• Does the test have a high degree of sensitivity and specificity?
• Does screening reach the population at risk?
• Does the cost effectiveness of screening compare favorably with competing interventions?
• National guidelines and recommendations
N/A
N/A
• Would consider participation.
• Factors to consider include small sample size, obtaining informed consent, and staff time and availability
Roger Eaton
NE Regional NBS Program
Univ of Massachusetts Med School
305 South St.
Jamaica Plain, MA 02135
Ph: 617-983-6300
Fax: 617-522-2846
Email: [email protected]
Follow-up Cordinator:
Cindy Ingham, RN, BSN
Vermont Dept of Health
Div of Health Improvement
Newborn Screening Prog
PO Box 70, 108 Cherry St
Burlington, VT 05402
Ph: 802-951-5180
Fax: 802-951-1218
Email: [email protected]
To add a new condition, we have direct statutory authority if it is part of the ACMG (or currently recognized) panel. If the pilot test is part of implementation process, then no additional authority is required.
Legislation enacted in 2009 requires establishment of advisory committee to work with the health department regarding future changes to panel. All appropriations (even appropriations due to increased fees) require legislative approval.
• ACMG recommendations
• 2009 enacted legislation allows health department to refer to 2005 ACMG report or other report that provides more stringent guidelines
Depends on the purpose & scope of the research as well as who will be doing the research.
Cannot report results until testing has been validated.
Studies would need to approved by the program and potentially would require approval of the Commissioner of Health and the IRB. Specimens or data that identify the individual cannot be released to external parties (per TX statute).
Susan Tanksley
Dept. of State Health Services
Laboratory Services Section
1100 W 49th St
Austin, TX 78756
Ph: 512-458-7430
Fax: 512-458-7221
Email: [email protected]
Follow-up Coordinator:
David Martinez
Dept. of State Health Services
Newborn Screening Branch
1100 W 49th St
Austin, TX 78756
Ph: 512-458-7111 x 2216
Fax: 512-458-7421
Email: [email protected]
Pilot testing not required but conducted usually just as method validation.
Advisory committee recommends changes. No regulations required.
ACMG recommendations
No consent required for validation studies.
Abnormal results reported during method validation.
Administrative Rule
Administrative Rule
In the past, national recommendations such as ACMG
SD NBS specimen's are not used for any purposes other than newborn screening.
N/A
N/A