Download Making a Difference at the State Level: New Jersey*s Approach to

CCHD Screening using Pulse Oximetry in the US:
An Amazing Public Health Story
Lorraine Freed Garg, MD, MPH
Consultant in Public Health
October 14, 2016
Critical Congenital Heart Defects

Approximately 9 in 1,000 live births with congenital heart defects
(CHD); 25% are critical congenital heart defects (CCHD)

Up to 25% of newborns with CCHD could be missed at the time
of hospital discharge

Between 100 and 200 newborns are estimated to have died each
year from missed CCHD
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Significant morbidity due to delayed diagnosis
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Mahle WT et al., Circulation 2009
Hokanson JS, Neonatology Today 2010
Detection of CCHD
60%
Prenatal
20%
Clinical
15.6%
Pulse Ox
4.4%
Diagnostic Gap
Riede FT et al., Eur J Pediar 2010
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CCHD Screening with Pulse Oximetry

Can detect mild hypoxemia without apparent cyanosis

Non-invasive and widely available
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Meta-analysis: 13 eligible studies; 229,421 newborns
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Sensitivity: 76.5% (95% CI 67.7 – 83.5)
Specificity: 99.9% (95% CI 99.7 – 99.9)
False-positive rate: 0.14% (95% CI 0.06 – 0.33)
Cost assessment
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CDC Study in 7 NJ Birthing facilities
Mean estimated cost/ newborn screened: $14.19
 $7.36 in labor costs
 $6.83 in equipment and supply costs
Thangaratinam et al., Lancet 2012 ;
Peterson et al., Public Health Reports 2014
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Timeline of CCHD Screening with
Pulse Oximetry
SACHDNC voted to add to RUSP (2010)
Early literature
1995
CHD Screening to
added to RUSP
(2011)
Tennessee Task
Force against
mandate (2005)
1999
2003
2007
2011
AAP and AHA statement (2009)
Legislation in
IN, NJ, MD
Large European Studies (2009-2011)
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AAP CCHD Screening Map: 2011 State
Actions on CCHD
3 states enacted legislation
Source: American Academy of
Pediatrics State Government Affairs
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AAP CCHD Screening Map: States’ Actions
During 2011-2012 (As of December 17, 2012)
Source: American Academy of 7
Pediatrics State Government Affairs
AAP CCHD Screening Map: States’ Actions
During 2013 (As of September 16, 2013)
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AAP CCHD Screening Map: States’ Actions
During 2014 (As of October 20, 2014)
Source: American Academy of
9
Pediatrics State Government Affairs
AAP CCHD Screening Map: States’ Actions
During 2016 (As of August 9, 2016)
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Multiple Stakeholders
Family
Advocates
Advocacy
Organizations
Professional
Organizations
Researchers
Universal
CCHD
Screening
Health Care
Providers
Legislators
Health
Departments
State and
Federal
Government
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Eve and Annamarie
Mpls St Paul Magazine, July 2016
Twin Cities.com, July 2016
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New Jersey’s Law
“The Commissioner of Health and Senior Services shall require
each birthing facility licensed by the Department of Health and
Senior Services to perform a pulse oximetry screening, a
minimum of 24 hours after birth, on every newborn in its care.”
 NJ first state to implement
a mandate for pulse oximetry screening
 Legislation signed into law
June 2, 2011
 Implementation date August 31, 2011
 P.L. 2011, Chapter 74
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Data Collection

Goal

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Screening results on all births
Detailed information on failed screens
Multi-Pronged Approach
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Screening information- all births
 Vital Information System (VIP)
2011 – planning
o 2015 - implemented
 Quarterly aggregate data –interim measure
o
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Information on Failed Screens
 Birth Defects Registry
 Information about screening result and outcome
 Relevant clinical information to
evaluate contribution of screening to detection
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Results of NJ Screening
August 31, 2011–December 31, 2014_______
Live births
338,124
Live births eligible to be screened* 328,591
Live births screened
327,447
Eligible live births screened
99.7%
*Excludes expirations, <24 hours, not medically appropriate at the end of the period
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Evaluating the Unique Contribution of CCHD Screening:
Failed Screens Registered to NJBDR 8/31/11 - 6/30/16
Pre-Identified Factors

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Prenatal diagnosis of
CCHD
Signs/symptoms at
the time of the
screen
Cardiac consult or
echocardiogram
planned prior to the
screen
Total fails
N= 295
>=1 Pre-identified
Factor
N= 162
CCHD
N= 25
No Pre-identified
Factors
N= 133
CHD
N= 19
PFO/PDA Other significant
medical
Only
conditions
N= 37
N= 10
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Importance of Training and Education

Provider Training
NJ Recommended Screening Algorithm
 Quick Reference Guide
 Birth Defects Registry Worksheet
 NJ CCHD Screening Reference Guide
 Grand Round Presentations
 Online course for nurses
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Parent Information (6 languages)
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Many Innovative Resources at the
Local and Regional Level
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Screening Special Populations
State-Led Activities
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Out of Hospital births
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High Altitudes
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WI, PA, MI, NJ mid-wife outreach and education
CO, AZ, UT-adjustments to algorithm at high altitude
NICU
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Multi-State Collaboration led by NJDOH and NJ AAP
5 States: California, Illinois, Minnesota, New Jersey, New York
Objectives:
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Determine exclusion criteria for screening in NICU
o Suspected prenatal CHD diagnosis
o Echocardiogram before screening
o Extreme prematurity
Burden of screening in the NICU at different times
Data forthcoming
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National Level Involvement

Federal Agencies
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HHS/HRSA
 Addition of CCHD screening to the RUSP
 6 Implementation Grants
 NewSTEPS Technical Assistance Center
o
o
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National CCHD Technical Assistance Webinars
Data repository
CDC
 Research and economic evaluations
 Support link between BDR and CCHD screening
 Supporting states and health departments

Professional Organizations



AAP
AHA
March of Dimes
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Challenges Remain


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No current Federal funding for health
departments (SHINE Legislation)
Special populations
Data collection not standardized
Not all states collecting data
 Data reporting not uniform

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What It’s All About
http://www.state.nj.us/governor/news/news/552011/approved/20111109a.html
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Acknowledgements
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New Jersey Department of Health Pulse Ox Team
NJ Chapter American Academy of Pediatrics
Centers for Disease Control and Prevention
New Jersey CCHD Screening Working Group
NJ’s Birthing Facilities
CCHD Screening Work Supported by:
Grant # H46MC24059 from the Genetic Services Branch
Division of Services for Children with Special Health Needs, Maternal and Child
Health Bureau, Health Resources and Services Administration (HRSA)
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24
BEGINNING
OF
EXTRA SLIDES
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CCHD Screening Targets
Seven Primary Targets
Five Secondary Targets
• Hypoplastic left heart syndrome
• Coarctation of the aorta
• Pulmonary atresia (intact ventricular
septum)
• Double outlet right
ventricle
• Tetralogy of Fallot
• Ebstein anomaly
• Total anomalous pulmonary venous return
• Interrupted aortic arch
• Transposition of the great arteries
• Single ventricle
• Tricuspid atresia
• Truncus arteriosus
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27
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Detected Through CCHD Screening
with Pulse Oximetry

Diagnostic evaluation attributable to POxS
(n=133)
25 - CCHD
 19 - CHD
 10 - Other significant non-cardiac
conditions
 37 - PDA or PFO as only finding
 22 - Identified during hospital quality control
activities
 20 – No documented reason for failed POxS

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