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Update on the Colorado Newborn Screening Program: Strengthening the - - PowerPoint PPT Presentation

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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:

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Update on the Colorado Newborn Screening Program: Strengthening the Foundation

August 15, 2018 Darren J. Michael, PhD, CC (NRCC), SC (ASCP)

Document 7 Presentation 1 of 20

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Blood S pot Program (LS D) Hearing Program (CHED) Crit ical Congenit al Heart Disease (CCHD) Program (CHED)

Newborn S creening in Colorado: Three S eparat e Programs

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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

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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 4 of 20

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CDPHE’s Newborn S creening Laboratory Contracted Medical S pecialists Birthing Facilities & Midwives Pediatricians & Family Medicine Physicians

1st S creen S pecimens 2nd S creen S pecimens 1st S creen Results 2nd S creen Results

Reference Laboratories— Diagnostic Testing APHL NewS TEPs NewS TEPs 360 HRS A Other S tates’ NBS Programs CDC— NBS Quality Assurance Program HHS S ecretary’s ACHDNC (Recommended Uniform S creening Panel— RUS P) ACMG S IMD March of Dimes National Peer-to-peer Network (already exists) Regional Peer-to-peer Network (being created)

Net works f or Newborn S creening

Document 7 Presentation 5 of 20

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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?

Answered: 110 S kipped: 0 (All Responses)

20.9% (23)

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Pediat ricians only… even less awareness

Answered: 63 S kipped: 0 (Pediat ricians only)

23.8% (15)

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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

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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

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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

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Foundational Pillar #1: Finance

  • 1. S

ustainable Financial Model

  • A. S
  • urces 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 11 of 20

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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 12 of 20

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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

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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

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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).

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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

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Birth Screen for Risk (2x) No Risk Identified Monitor Development

Upcoming Requests for Rulemaking Define Roles and Responsibilities for Follow-up

Primary Care Physicians (PCP’s) Connect to Care Treatment Risk Confirmed Contracted Medical Specialists & PCP’s Risk Identified Risk not Confirmed

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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)

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S ummary

  • Comprehensive Review
  • Four Pillars
  • Finance
  • Personnel
  • Infrastructure
  • Authority
  • Rulemaking—

Fall ‘ 18

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Acknowledgements

Colorado Newborn Screening Laboratory Colorado Dept. of Public Health & Env. (main campus) Laboratory Services Division Accessioning Group Gabriel Pless Dominique S tewart Kristin Ondreiko Arick Goldman Corina S tark Colorado Newborn Screening Stakeholders’ Committee Finance Group Olga Ivanova Kristi Gamble Jaqui Maharaj Office of IT (OIT) Greg Bonn Marilyn Heil Cory Porter S udhi Rao, PhD Abena Watson-S iriboe Paula Brallier Kay Reilly Rachel Rodriguez Kyle S enger Molly Maskrey Kirida S in Julia Gray Eric Winkleman George Dinakar BJ Brumfiel John Marthe Cynthia Foreman Jyoti Kochhar Jalene Rocha Alicia Castro Kris Kiburtz Amy Robertson Chris Pearce Randy Kuykendall Emily Travanty, PhD Kelly Doak Lauren Farnsworth Justin Nucci Vickel Maharaj Larry Wolk, MD, MS PH Tista Ghosh, MD, MPH Margaret Ruttenber, MS PH Chris Wells, PhD Ann Hause Joni Koenig Bill Vertrees Deborah Nelson

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