California Newborn Screening Program Update
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1 California Newborn Screening Program Update Robin Thomas, BSN, MPA Nurse Consultant, Specialist Genetic Disease Screening Program May 10, 2018
2 Goal of Screening Screening is a public health service designed to identify individuals in a population who may be at an increased risk of developing a disease before symptoms become apparent.
3 NBS Notification Process The Newborn Screening process starts with prenatal education. Each mother should receive the IIP Booklet during prenatal care. The mother/legal guardian should also receive the IIP Tri-fold before the NBS is collected at the hospital or birth center.
4 Newborn Screening is Law NBS is mandated in California and is governed by the Health and Safety Code and California Code Of Regulations. These laws and regulations cover most aspects of Newborn Screening such as: What disorders are screened for When screening should be done The fee for the test (currently $129.25) Families can only refuse on religious grounds.
5 Advisory Committee on Heritable Disorders in Newborns and Children In 2008 Congress passed the Newborn Screening Saves Lives Act which was the legal basis for the federal Advisory Committee on Heritable Disorders in Newborns and Children. This committee is charged with evidence based review of data regarding the benefits of screening for specific disorders and in 2010, the federal Department of Health and Human Services established a Recommended Uniform Screening Panel (RUSP) based on their recommendation. The RUSP currently contains 34 core (primary) conditions and 26 secondary ones.
6 How Does A Condition Become Part Of The CA Panel Today? 2016 legislation (SB 1095) mandated that the California NBS program will now begin screening for new conditions as they are added to the RUSP. The bill allows a period of two years to start the testing.
7 A Brief History of Newborn Screening Expansion in California
8 California NBS expansion, Chapter 393, Statutes of 2016*: The department shall expand statewide screening of newborns to disease that is detectable in blood samples as soon as practicable, but no later than two years after the disease is adopted by the federal Recommended Uniform Screening Panel (RUSP), or enrollment of the act amending this subdivision, whichever is later. * Three most recent additions to the RUSP: Adrenoleukodystrophy (ALD) 2/2016 Glycogen storage disease type II (GSD II: Pompe disease) 8/2018 Mucopolysaccharidosis type I (MPS I) 8/2018
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10 Timeliness In Newborn Screening
11 Goal of NewSTEPs 360 To support states through technical and financial means so that they can achieve timely reporting of results in 95% of newborns that receive dried-blood spot (DBS) newborn screening.
12 Goal of NewSTEPs 360
13 timely ACHDNC s recommendations 1.Presumptive positive results for time-critical conditions should be communicated immediately to the child s healthcare provider but no later than the 5th day of life. 2.All presumptive positive results for all other conditions should be communicated to the child s healthcare provider as soon as possible but no later than 7 days of life. 3.All NBS results should be reported within 7 days of life.
14 CA Timeliness In Newborn Screening In order to achieve these goals and reduce delays in newborn screening: 1.Initial NBS specimens should be collected in the appropriate time frame of 12 to 24 hours, but no later than 48 hours after birth. 2.NBS specimens should be received at the Laboratory as soon as possible; ideally within 24 hours of collection.
15 CoIIN
16 CoIIN
17 California Regulations updated 04/16 all birth providers to provide Newborn Screening NBS collection 12 hours to 48 hours after birth shipment to the lab on the same or next business day Birth registrars to send the NBS-OH form on the next business day of receipt deletion of the NBS-NO (not-obtained) form which is now a part of the NBS-TRF form (collection form).
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21 Regulations changes underway 05/18 Pending NBS Fee Increase effective July 1 - $ fee increase to enable screening for Pompe and MPS 1. Deletion of the NBS-TR (test refusal) form which will become a part of the NBS-TRF form (32 series collection form).
22 Test Request Form Changes The 32 Million Series TRF formatting changes and a special filter paper to be split at the NAPs lab to facilitate testing of new disorders at GDL. New forms shipping early June One time credit exchange for 31 Million series
23 Area Service Centers (NBS-ASCs) Stanford University Medical Center, Palo Alto Valley Children s Hospital, Madera UCLA Medical Center Harbor/UCLA Medical Center Rady Children s Hospital, San Diego Kaiser Permanente North { { Kaiser Permanente, Northern CA Kaiser Permanente, Southern CA Kaiser Permanente North
24 Thank You!
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