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Policy Analysis

Sandra Diaz

Nova Southeastern University

Newborn Screening for Congenital Heart Disease

I represent the American Heart Association and this organization support Bill HB 81. The American Heart Association has been dedicated to the treatment and prevention of cardiovascular diseases of all age groups. Furthermore, our mission and goal is to" build healthier lives, free of cardiovascular disease, this is the single purpose that drives all we do and the need for our work is beyond question"(American Heart Association, n.d). Therefore, it is evident that this organization firmly support early screening, treatment and prevention of cardiovascular diseases.
Congenital heart disease is the most common birth defect among newborns, affecting eight out of every one thousand newborn babies(Ewer et. al, 2011). It is also the leading cause of death among newborns within the first year of life. Early detection of congenital heart disease is crucial to newborn health and prevention of major problems later in child's life. Additionally, if detected early, congenital heart defects can be treated with surgical interventions or medication, depending on the severity. Pulse oximetry, a simple non invasive test and will be implemented as a screening tool for congenital heart disease(Kemper et. al, 2011).
Bill HB 81 - Newborn Screening for Critical Congenital Heart Disease was sponsored by Cary Pigman(Republican, District 55) and Karen Caster Dentel(Democrat, District 30)(Florida House of Representative, n.d.). This bill was filed on January 2,2013; passed on March 5, 2013 and will be effective on July 1, 2013. Bill HB 81 will require that all newborns in the state of Florida, born in a birthing center or hospital must be screened for congenital heart disease. Additionally, beginning no later than October 1, 2013 screening for congenital heart disease be conducted on all newborns in the state of Florida following birth admission. Bill HB 81 will also require all insurance companies implement measures to cover the cost associated with screening.
Key Policy Events
There has been several previous legislation attempts to pass a bill both in the Florida Senate and House of Representatives regarding newborn screening and congenital heart disease. However, none of these bills were approved and died before being approved in either the Senate or the House of Representative. The following is a list of previous bills filed in 2011 and 2012, that died in the Committee.
 Bill SB 1052 - New born Screening for Critical Congenital Heart Disease, Filed November 21, 2011 by Jeremy Ring(Democrat, Florida Senate, District 29). However, on 3/9/12, this bill died in the Budget Subcommittee on Health and Human Services Appropriations(Florida Senate, n.d).
 Bill HB 829- New born Screening for Critical Congenital Heart Disease, filed November 17, 2011 by Ari Porth(Democrat, Florida House of Representative, District 96).However, on 3/9/12, this bill died in the Health and Human Services Quality Subcommittee(Florida House of Representative, n.d).
 Bill SB 1006- Providing requirements for screening newborns for congenital heart disease, filed November 11,2011 by Jack Latvala(Democrat, Florida Senate, District 20). However, this bill died in the Budget Committee on 3/9/12.
Therefore, it is evident that in the past two years several attempts has been made to pass a bill that will screen newborns at birth for congenital heart disease. However, these bills died in the budget committee twice and this indicates that these bills were not approved because of cost to stakeholders.

Financial Data
Pulse oximetry is non invasive method to monitor the saturation of a patient hemoglobin(Kemper et. al, 2013). The health care costs that is associated with use of the pulse oximetry is minimal. It is estimated that it will cost $10.00 per infant to be screened (Kemper et. al, 2013). Therefore, some may argue that this screening will take up more staff time specifically for screening and educating parents if a screening is positive. However, it will take a nurse between than one minute and five minutes to perform this screening and this is minimal time(Kemper et. al). Furthermore, the benefits of pulse oximetry testing outweighs the costs and time, because it will save the lives of many newborns with early diagnosis and treatment.

Key/Major Stakeholders The stakeholders affected by this bill will be hospitals, nurses, physicians and insurance companies. In regards to the hospitals, it is their view that this screening will be time consuming and costly . Hospital cost are associated with maintenance of equipment, and those that are associated with screening such as probes, adhesive wraps and cleaning supplies. Insurance companies argue that will have to reimburse hospitals more for screening, although it was estimated to cost approximately $10.00 per screening. Physicians support this screening and agree that it will save many newborn lives. Nurses also agree that pulse oximetry screening will save lives; however they complain that it will be time consuming. Furthermore, nurses need to be informed that this screening will only take between one and five minutes.

Social, Economic, Ethical, Legal and Political Factors In regards to social factors, congenital heart defects is a major cause of death in newborns especially in developed countries. Additionally, approximately 9 of every 1000 births will be affected by a congenital heart defect(Swenson et. al, 2012).Newborn screening in the State of Florida is a public health issue that is aimed at the early detection and treatment of congenital heart defects. Furthermore, those newborns with a positive pulse oximetry, will have the opportunity for early intervention. According to Ewer et. al(2012), a pulse oximetry study that was conducted on 20,055 newborns resulted in one hundred and ninety five of these newborns having a positive pulse oximetry test; of these 26(13%), were found to have critical or major congenital heart defects and needed surgical interventions, the remaining newborns had less serious heart defects and respiratory disorders, which required only medical intervention. Therefore, it is evident pulse oximetry is a necessary screening tool to decreased mortality among those neonates with congenital heart defects.
In regards to the sensitivity of pulse oximetry it has a sensitivity of 75%(95% confidence interval) and a specificity of 99.1% (95% confidence interval) for detecting critical heart defects(Ewer et. al, 2012). Additionally, sensitivity of pulse oximetry for all major congenital heart defects was 49%(95% confidence interval) and specificity was 99.2%(95%confidence interval)(Ewer et.al, 2012). Therefore, pulse oximetry testing is a reliable indicator for those newborns with congenital heart defect. Additionally, the use of pulse oximetry will also augment the detection of other disease, such as those with a respiratory and infective source.
In regards to economic factors early screening and treatment will decrease health care cost. Although, initially implementation of this program may be costly, long terms benefits of this screening will result if decrease cost associated with complications from congenital heart defects. It is estimated that each pulse oximetry screening will cost only $10.00 and this is minimal(Kemper et. al, 2013). Therefore, the implementation of this screening program will decrease health care cost in the long term because it will allow for early treatment and intervention. According to Kemper et. al (2013), the savings in healthcare costs due to complications of one patient with congenital heart defect because it was undiagnosed will exceed the cost of screening two thousand newborns.
In regards to legal factors pulse oximetry screening will allow prompt diagnosis of congenital heart defects and thereby decreasing legal implications such as those associated with malpractice. Hospitals and birthing centers where newborns are born with a congenital heart defect and appropriate screening such as pulse oximetry has not been implemented to detect heart defects, are at an increase risk for legal action. According to Mahle et. al(2012), "pulse oximetry enhance the detection of congenital heart disease and is readily available, noninvasive and painless"(p.190). Therefore, implementing a simple and quick procedure will decrease a hospital of birthing center liability risks.
In regards to ethical factors, all human life is precious and valuable. Therefore, pulse oximetry testing which is a simple and non invasive test, that has been clinically effective in detecting heart defects ,should be available and implemented in all hospitals and birthing centers. Congenital heart defects that are detected early will result in decrease morbidity because treatment will be implemented. Therefore, it is ethically important to implement this life saving screening tool, so that it will be available to save the lives of many newborns.
In regards to political factors, there has been support for pulse oximetry screening from several other organizations such as the Center for Disease Control and The American Academy of Pediatrics. In September 2010, the U.S Department of Health and Human Services Secretary's Advisory Committee on Heritable Disorders in Newborn and Children voted to add congenital heart defect screening to the Recommended Uniform screening Panel(Centers for Disease Control, 2012).Additionally, on September, 11, 2011 the secretary of Health and Human Services Kathleen Sibelius recommended that pulse oximetry screening be included as part of the Recommended Uniform Screening Panel for Newborns(Center for Disease Control, 2012). There are several states that have implemented the use of pulse oximetry and others in which there is currently legislation to adopt this screening process, to detect congenital heart defects. Therefore, pulse oximetry screening is recognized as an effective method to detect congenital heart disease.
Policy Intervention Options
An alternative to pulse oximetry screening for congenital heart defect is to require that all newborns have a electrocardiogram prior to discharge from hospital. An electrocardiogram would also be able to accurately detect if a newborn has a congenital heart defect. However, the cost of an electrocardiogram is approximately $60 - $100(Swenson, 2012). An electrocardiogram also requires more time to complete, and results has to be correlated with cardiologist. Therefore, although an electrocardiogram may be an alternative in the screening of congenital heart defects, it is not cost effective.
Proposed Recommendation
I strongly recommend the use of pulse oximetry in the screening of congenital heart disease. Pulse oximetry testing is reliable, efficient , low cost and can be performed quickly by nursing staff as part of their assessment. Furthermore, early detection will result in immediate intervention and treatment, which will result in decrease long term complications and decrease health care cost. Stakeholders will also benefit from use of pulse oximetry because it will result in decrease health care cost, minimize legal implications and result in decrease mortality.
Conclusion
Currently, in the state if Florida there are not any mandatory screening for congenital heart disease. Therefore, implementing pulse oximetry screenings for detecting congenital heart disease will save the lives of many newborns by allowing for early intervention. Additionally, pulse oximetry is a non invasive and reliable screening tool. Screening for congenital heart disease with the use of pulse oximetry is also more cost effective as compared to an electrocardiogram. Every newborn should have a pulse oximetry screening done prior to discharge from the hospital and this screening should be mandatory.

References
American Heart Association.(n.d). Mission Statement. Retrieved http://www.heart.org/advocacy.
Centers for Disease Control.(2012). Screening for critical congenital heart disease. Retrieved http://www.cdc.gov/ncbddd/pediatricgenetics/pulse.html.
Ewer, A.K., Middleton,L.J., Furmston, A.T., Bohyar, A., Daniels, J.P., Thangaratinam, S., Deeks, J.J., & Kahn, K.S. (2011). Pulse oximetry screening for congenital heart defects in newborns: a test for accuracy. Journal of Pediatrics, 152, 761-765.
Florida House of Representative. (n.d.). HB 81 Newborn screening for critical congenital heart disease. Retrieved http://www.myflorida.gov/Sections/Bills/billsdetail.aspx?BillId=49268.
Florida Senate(n.d). SB 1052 Newborn screening for critical congenital heart disease. Retrieved http://www.myfloridahouse.gov/sections/bills/billdetail.aspx?BillId=47984.
Kemper, A.R., Mahle, W.T., Martin, G.R., Cooley, W.C., Kumar, P., Morrow, R., Kelm, k., Pearson, G.D., Glidewell, J., Grosse, S., & Howell, R.R.(2011). Strategies for implementing screening for critical congenital heart disease. Journal of American Academy of Pediatrics,128(5), e1259-e1267.
Mahle, W.T., Newburger, J.W., Matherne, G.P., Smith, F.C., Hoke, T.R., Koppel, R., Gidding, S.S., Beekman, R.H., & Grosse, S.D.(2009). Role of pulse oximetry in examining newborns for congenital heart disease: a scientific statement from the AHA and AAP. Journal of American Academy of Pediatrics, 124(2), 823-836.
Swenson, A.K., Brown, D., & Stevermer, J.J.(2012). Pulse oximetry for newborns: should it be routine?. Journal of Family Practice, 61(5), 283-286.

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