|DAVID L. LAKEY, M.D.
1100 W. 49th Street • Austin, Texas 78756
P.O. Box 149347 • Austin, TX 78714-9347
1-888-963-7111 • http://www.dshs.state.tx.us
December 20, 2011
RE: Newborn Screening Healthcare Provider Requirements regarding the Use and Storage of Newborn Screening Blood Spot Cards
Dear Healthcare Provider,
House Bill 411, of the Texas Legislative 82nd session, changes the consent requirements for the use and storage of newborn screening (NBS) blood spot cards from an opt-out system in which parents may request their child’s specimens be destroyed to an opt-in system in which parents must provide consent in order for the residual specimens to be used for external research or stored more than two years. Due to changes in the law, the requirements for how healthcare providers who collect newborn screening specimens provide the information and decision forms will change. These new requirements will take effect on (but not before) June 1, 2012.
Beginning June 1, 2012, healthcare providers will be required to distribute new parent information and decision forms to parents with each newborn screening specimen collection.
- New forms will be included as part of the 2012 newborn screening specimen collection kits. (available in early 2012)
- 8 ½ X 11 versions of the new forms will be available on the Texas Newborn Screening Laboratory website.
- Prior to June 1, 2012, providers must continue to distribute the form “Use and Storage of Newborn Screening Blood Spot Cards / Directive to Destroy…” (Page 2 of the current 2010 or 2011 newborn screening specimen collection kits) to parents with each NBS specimen collection.
- Beginning June 1, 2012, current (2010 and 2011) NBS collection kits will still be valid except for the “Use and Storage of Newborn Screening Blood Spot Cards / Directive to Destroy…” form on Page 2.
- The Texas Newborn Screening Program is working to develop instructions and recommendations for healthcare providers to implement the new requirements. More information will be distributed in early 2012.
- An electronic example of the new forms will be made available for informational purposes as soon as the final version is approved.
- The Texas Newborn Screening Program will provide regular updates about the implementation of changes through mail outs, the Texas NBS Listserv email distribution system and on the laboratory website http://www.dshs.state.tx.us/lab/newbornscreening.shtm.
For answers to any additional questions, to provide comments, or to request to receive email notification through the Texas NBS Listserv, please contact the Newborn Screening Laboratory at 1-888-963-7111 ext. 7333 or email NewbornScreeningLab@dshs.state.tx.us
Grace Kubin, Ph.D.
Director, Laboratory Services Section