Document 7 Presentation 1 of 20 Update on the Colorado Newborn Screening Program: Strengthening the Foundation August 15, 2018 Darren J. Michael, PhD, CC (NRCC), SC (ASCP)
Document 7 Presentation 2 of 20 Newborn S creening in Colorado: Three S eparat e Programs Blood S pot Program (LS D) Hearing Program (CHED) Crit ical Congenit al Heart Disease (CCHD) Program (CHED)
Document 7 Presentation 3 of 20 Personal Connect ion t o Newborn S creening (not in Colorado) • ‘ Confirmed’ Carnitine Uptake Disorder • Reliance on personal knowledge and personal network to resolve as false positive
Document 7 Presentation 4 of 20 Get t ing st art ed… • Internal Review • What do we do? • Why do we do it? • Is there a better way to do it? • Where are the systemic risks? • Engage with Stakeholders • Listen • Understand their challenges • Connect peers with peers
Document 7 Presentation 5 of 20 Net works f or Newborn S creening Regional Peer-to-peer Network (being created) Reference Laboratories— Contracted Medical Diagnostic Testing S pecialists Birthing Facilities & Pediatricians & Family Midwives Medicine Physicians 1 st S 2 nd S creen creen S pecimens S pecimens 1 st S 2 nd S creen creen Results CDPHE’s Newborn Results S creening Laboratory HHS S ecretary’s ACHDNC APHL (Recommended Uniform NewS TEPs CDC— NBS Quality S creening Panel— RUS P) NewS TEPs 360 Assurance Program ACMG HRS A S IMD Other S tates’ NBS March of Dimes Programs National Peer-to-peer Network (already exists)
Document 7 Presentation 6 of 20 S urvey of S t akeholder Awareness: Are you aware of t he Colorado Board of Healt h Rules (and procedures) governing newborn blood spot screening? 20.9% (23) Answered: 110 S kipped: 0 (All Responses)
Document 7 Presentation 7 of 20 Pediat ricians only… even less awareness 23.8% (15) Answered: 63 S kipped: 0 (Pediat ricians only)
Document 7 Presentation 8 of 20 Engagement wit h S t akeholders Colorado Newborn S creening S t akeholders’ Commit t ee Colorado Newborn S creening Newslet t er Educat ion, Out reach and S t akeholder Engagement Peer-to-peer Networking Events August 18, 2018— Colorado S prings August 14, 2018— Larimer County Fairgrounds August 23, 2018— Grand Junction August 27, 2018— Denver
Document 7 Presentation 9 of 20 Current Program Priorit ies Meet ing t he current demand Operates at least six days a week Increase electronic access to NBS results Leverage rules in existing regulations across CDPHE — HFEMS (Birth Facility rules) — DCEED (Colorado Immunization Information S ystem) Elegance, Efficiency and Effectiveness … wit h t he aim of st rengt hening t he program’ s foundat ion
Document 7 Presentation 10 of 20 Pillars of t he Newborn S creening Foundat ion 1. Finance 2. Personnel 3. Infrast ruct ure/ Equipment / IT 4. Aut horit y • Colorado Board of Health • CDPHE’ s Executive Director • Division Policies and Procedures
Document 7 Presentation 11 of 20 Foundational Pillar #1: Finance 1. S ustainable Financial Model A. S ources of Revenue I. Fee-for-service model— cash fund II. Grants (APHL, NewS TEPs, CDC and HRS A) B. Model for Expenses— Clinical Laboratory Fee S chedule (CMS ) 2. Current S tatus of the NBS Fund— Accruing funds for future investments Laboratory Information Management S ystem (LIMS ) >10 years old
Document 7 Presentation 12 of 20 Foundational Pillar #2: Personnel 1. Right Number of S taff 2. Right Mix of People— mass spectrometry, molecular testing, analytics 3. Engage with Professional Peers • APHL/ CDC Training Workshops (3) • National Newborn S creening Committees • S ite Visits— CDC S taff
Document 7 Presentation 13 of 20 Foundational Pillar #3: Infrastructure 1. Equipment— ’ Ownership’ model 2. S pace— S pace study begins in S eptember 2018 3. Information Technology— Network, servers, configuration 4. Laboratory Information Management S ystem— • S trengthening the current system • Finding a replacement
Document 7 Presentation 14 of 20 Foundational Pillar #4: Authority 1. Board of Health • Update existing rules • Create new rules (statutory requirement) 2. CDPHE’s Executive Director 3. Establishing Policies and Procedures to Address the Complexities of the Newborn S creening S ystem
Document 7 Presentation 15 of 20 Current Board of Healt h Rules Currently screen for 37 conditions Current Process: • Federal component • S tate-specific component • Here’ s how we do it in CO: The Department reviews national recommendations and explores the costs and benefits with stakeholders. Propose rulemaking for the Board’ s consideration as appropriate. New Component: • Review by the Colorado General Assembly now required under (HB 18-1006).
Document 7 Presentation 16 of 20 Upcoming Requests for Rulemaking: Implement Rule Review Results, Program Process Improvements, and HB 18-1006 • Update terminology • Clarify current requirements • Align the rule language with a supportable and efficient program infrastructure • Align the rule language with the provider structure • Rules to implement HB 18-1006: Handling, delivery and receipt of samples Define follow-up services
Document 7 Presentation 17 of 20 Upcoming Requests for Rulemaking Define Roles and Responsibilities for Follow-up Primary Care Physicians (PCP’s) No Risk Risk not Identified Confirmed Birth Screen for Risk (2x) Monitor Development Risk Identified Connect Risk Treatment to Confirmed Care Contracted Medical Specialists & PCP’s
Document 7 Presentation 18 of 20 Long-t erm Planning Once foundation has been strengthened… Consider the four (4) conditions on the national Recommended Uniform S creening Panel but not on CO panel (“ New Conditions” ) — Pompe Disease (previously considered by BoH— S eptember 2015/ April 2016) — X-linked Adrenoleukodystrophy (X-ALD) — Mucopolysaccharidosis Type 1 (MPS -1) — S pinal Muscular Atrophy (S MA)
Document 7 Presentation 19 of 20 S ummary • Comprehensive Review • Four Pillars • Finance • Personnel • Infrastructure • Authority • Rulemaking— Fall ‘ 18
Document 7 Presentation 20 of 20 Acknowledgements Colorado Newborn Screening Laboratory Accessioning Group Gabriel Pless Greg Bonn Paula Brallier Dominique S tewart Marilyn Heil Kay Reilly Kristin Ondreiko Cory Porter Rachel Rodriguez Arick Goldman S udhi Rao, PhD Kyle S enger Corina S tark Abena Watson-S iriboe Molly Maskrey Finance Group Olga Ivanova Colorado Dept. of Public Health & Env. Kristi Gamble (main campus) Jaqui Maharaj Ann Hause Larry Wolk, MD, MS PH Joni Koenig Tista Ghosh, MD, MPH Office of IT (OIT) Bill Vertrees Margaret Ruttenber, MS PH Cynthia Foreman Kirida S in Deborah Nelson Chris Wells, PhD Jyoti Kochhar Julia Gray Jalene Rocha Eric Winkleman Laboratory Services Division Alicia Castro George Dinakar Randy Kuykendall Lauren Farnsworth Kris Kiburtz BJ Brumfiel Emily Travanty, PhD Justin Nucci Amy Robertson John Marthe Kelly Doak Vickel Maharaj Chris Pearce Colorado Newborn Screening Stakeholders’ Committee
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