OFFI CE OF THE SECR:TARY 2015 APR 10 AH1f:39

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1 COUNCIL OF THE DISTRICT OF COLUMBIA COMMITTEE ON HEALTH AND HUMAN SERVICES COMMITTEE REPORT 1350 Pennsylvania Avenue, NW, OFFI CE OF THE SECR:TARY 2015 APR 10 AH1f:39 TO: FROM: DATE: All Councilmembers Councilmember Yvette M. Alexander, Chairperson, Committee on Health and I!uman Services ~ April 2, 2015 SUBJECT: Report on Bill 21-6 the "Health y I!carts of Babies Act of 2015" The Committee on Health and I Iuman Services, to which Bill 21-6 wa. referred, reports favorably thereon and recommends approval by the Council. CONTENTS I. Background and Nced l II. Legislative Chronology... 2 III. Po. ition of the Executive... 3 IV. Comments of Advisory eighborhood Commissions... 3 V. List of Witnesses... 3 VI. Impact on Existing Law...? VII. Fiscal Impact...? VI 11. Section-by-Section Analysis... 8 IX. Committee Action... 8 X. Altachments... 9 I. BACKGROUND & NEED The slated purpose of Bill 21-6 is to require every newborn delivered in a hospital, maternity center, or home to be screened for critical congenital heart disease using pulse ox imetry or in another manner as directed by the Department of 1 lealth. Congenital heart disease ("CHO") is a group of defects that arc present from birth and affect the structure of the heart. Cl IDs arc the most common birth defect in the United States affecting nearly l out of every 100 births or 40,000 births annually 1 Infants with CHDs may be born with hearts that have incomplete or missing parts, have holes between chamber partitions or have narrow valve. or vessels. The defects range in severity from those that do not require any further treatment to those that require multiple open heart operations. A defect that requires 1 rtdefects/data.html 1

2 surgery or another operation within the first year of life is generally referred to as a critical congenital heart disease ("CCHD"). Often times, CCHD's have no symptoms and often go unnoticed by examining physicians. When symptoms are present, they can be extremely mild such as rapid breathing, a bluish hue in the newborns skin, fatigue, or poor circulation in the infant. The slight nature of the symptoms makes it unlikely that a parent will be able to identify the issue on their own and this raises the chances of the CCHD going untreated. CCHD affects 4 in 1000 babies born each year and is the leading cause of death for babies born with birth defects. It is possible for these heart defects to be caught during prenatal ultrasounds however; most defects remain undetected through childbirth. Effective and timely screening is necessary to save affected infant's lives. In September 2011, the Secretary of the US Department of Health and Human Services (HHS) formally adopted the recommendation from the Secretary's Advisory Committee of Heritable Disorders in Newborns and Children to add CCHD to the Recommended Uniform Screening Pane1 2 Essentially, the federal government determined that all newborns should be screened for CCHDs. Subsequent to this recommendation, the American Academy of Pediatrics, among others, advocated for the use of pulse oximetry in screening newborns for CCHDs 3. Pulse oximetry is a screening mechanism that is widely used across the nation to screen infants for CCHDs. It is quick, inexpensive, and painless while taking less than 4 minutes to perform. During pulse oximetry screening, a probe is attached to the hand and foot of an infant. The probe then determines the oxygen saturation level in the infant's blood. When administered shortly after birth, heart defects can be found quickly thus ensuring that physicians are able to treat these issues early. This can potentially save an infant's life. At the hearing, numerous witnesses testified to the impact that a timely pulse oximetry screening had on their child's health. Although these children had been born with extremely dangerous heart defects, their parents testified that they had been able to lead relatively normal healthy lives after their respective procedures. Nationwide, great advances have been made in identifying and treating CCHDs and survival rates are now approaching 96% 4 Washington D.C. hospitals are all currently administering CCHD screening programs on their own volition. However, congenital heart disease is still the leading cause of death for babies born with a birth defect. Through this legislation, the need to administer this life saving screening will be the law and access to pulse oximetry will be guaranteed for all infants born in the District. II. LEGISLATIVE CHRONOLOGY January 6, 2015 Bill 21-6 is introduced by Councilmembers Alexander, Grosso, Allen, Evans, Bonds, and Cheh and co-sponsored by Chairman Mendelson at Legislative Meeting. 2 Testimony of Nancy Schoenfeld 3 Testimony of Nancy Schoenfeld 'Testimony of Joseph L. Wright, MD, MPH 2

3 January 6, 2015 January 9, 2015 January 16, 2015 February 2, 2015 April 2, 2015 Bill 21-6 is referred to Committee on Health and Human Services. Notice of Intent to Act on Bill 21-6 published in the District of Columbia Register. Notice of Public Hearing published in the District of Columbia Register. Committee on Health and Human Services holds public hearing on Bill The Committee on Health and Human Services meets to mark-up and vote on the report and committee print of Bill Ill. POSITION OF THE EXECUTIVE Ryan Springer, Senior Deputy Director, Community Health Administration, testified in support of the bill. Mr. Springer expressed that the Department of Health (DOH) understands the importance and paramount need to mandate timely screenings of newborns for critical congenital heart defects. Nationally, approximately l in every 4 babies born with a heart defect has a critical congenital heart defect; early detection and timely care of these babies may prevent disability or death early in life. Mr. Springer also provided proposed rulemaking based on the recommendations of the Mayor's Advisory Committee on Metabolic Disorders, which would implement mandatory screening of all newborns in the District of Columbia for congenital heart defects - this was forwarded to the Mayor's committee in January of this year. It is Mr. Springer's, and DOH's, position that these rules will benefit newborns, their families, and medical practitioners in the District. IV. COMMENTS OI< ADVISORY NEIGHBORHOOD COMMISSIONS The committee received no testimony or comments from Advisory Neighborhood Commissions. V. LIST OF WITNESSES AND SUMMARIES OF TESTIMONY 1. Dr. Gerard Martin Senior Vice President & Medical Director, Children's National Health System, American College of Cardiology 2. Dr. Joseph Wright 3. Nancy Schoenfeld Chair and Professor, Howard University Department of Pediatrics D.C. Academy Chapter of the American Academy of Pediatrics 3

4 4. Marie Pokraka 5. Michelle Coleman 6. Katie Mooshian 7. Amy Shalawylo 8. Hilary Mehrkam 9. Meredith Atkinson 10. Mirabel Atkinson 11. Daniel Batlle 12. Keri Sikich Chapter Director of Program Services, March of Dimes Public Witness Public Witness Public Witness Public Witness Public Witness Public Witness Public Witness Public Witness 13. Stephanie Wright 14. Tristan Wright 15. Olivia Easely Hi. Stuart Berlow 17. Lisa Hom 18. Dr. Mary Revenis 19. Joanne Adelberg 20. Robert Malson Public Witness Public Witness Public Witness Director of Gov.ernmcnt Relations, American Heart Association Clinical Program Manager, Children's National Heart Institute Chairman, Fetus and Newborn Committee of the DC American Academy of Pediatrics Chair, District of Columbia Committee on Metabolic Disorders President, D.C. Hospital Association Executive Witness 21. Ryan Springer Interim Director, Department of Health 4

5 Dr. Gerard Martin, Senior Vice President at Children's National Health System, testified in support of the bill. Explaining that Congenital Heart Disease is the most common birth defect, impacting nearly 1 out of every 100 babies, Dr. Martin expressed that failing to detect this critical disease in time can cause cognitive and developmental delays, leading to life-long disabilities. This legislation, he stated, would mandate a quick, painless, and effective screening mechanism and is the only way the District can ensure that no baby has slipped through the cracks. Dr. Joseph Wright, Professor and Chairman at Howard University's Department of Pediatrics and Child Health, testified in support of the bill. Dr. Wright stated that the bill represents an important public health step forward in enacting legislation that will systematically save young lives, as well as introduce a fiscally responsible approach to the early detection of a potentially devastating condition. Nancy Schoenfeld, Executive Director of American Academy of Pediatrics, DC Chapter, testified in support of this bill. She says if not detected early, CCHD can have profound consequences on a child's life; Bill 21-6 would mandate a screening that is inexpensive and readily available, and would allow for the detection of additional illnesses, such as sepsis, pneumonia, and congenital diaphragmatic hernias. Among a list of recommendations Ms. Schoenfeld provided the committee, she included a requirement that screening be documented and reported to the DC Department of Health, and that primary care physicians work to facilitate long-term follow-up for children diagnosed with critical CCHD. Marie Pokraka, Chapter Director of Program Services at March of Dimes, testified in support of the bill. She expressed that babies with CCDH are at critical risk for death or disability if their condition is not diagnosed soon after birth. Close to 300 babies are discharged with undetected congenital heart disease each year, an issue that can be avoided with mandatory screenings. Michele Coleman, Public Witness, testified in support of the bill. Ms. Coleman testified to the experience of her two year old son, Dylan, who was born with three CHD's and underwent open heart surgery at seven days old. Because Dylan was born in a Silver Spring hospital, which provided pulse oximetry testing, his condition was detected early and taken care of. Ms. Coleman is advocating for District hospitals to offer this same testing as protocol so that CHO can be detected. Katie Mooshian, Public Witness, testified in support of the bill. Ms. Mooshian delivered testimony similar to Ms. Coleman, in which her son suffered from a cardiac condition that was pre-diagnosed thanks to pulse oximetry. Ms. Mooshian stressed the importance of using this inexpensive and non-invasive tool to keep babies, like hers, from slipping through the cracks. Amy Shalawylo, Public Witness, testified in support of the bill. Ms. Shalawylo's testimony echoed that of Ms. Mooshian and Ms. Coleman. The mother of a child who was born with a congenital heart defect, Ms. Shalawylo expressed that the pulse oximetry readings gave her great insight into how her son's heart was functioning while his lungs took over the work of supplying oxygen. Had the screening not taken place, signs of health decline may have been overlooked. 5

6 Hilary Mehrkam, Public Witness, testified in support of the bill. Ms. Merkham's daughter suffered from a heart defect, which was detected during her pregnancy thanks to a pulse oximetry screening. Though her baby underwent open-heart surgery and survived, Ms. Mehrkam learned of countless babies who didn't. "No other babies should die or suffer serious adverse health consequences because they aren't provided with such a simple, non-invasive test after being born" she testified. Meredith Atkinson, Public Witness, testified in strong support of the bill. Ms. Atkinson, like previous witnesses, gave birth to a child with a highly complex congenital heart defect that was diagnosed early thanks to pulse ox screening. Ms. Atkinson stressed that positive outcomes are possible with early diagnoses through mandatory pulse oximetry screenings. Mirabel Atkinson, Public Witness and daughter of Meredith Atkinson, echoed her mother's testimony and testified to the importance of pulse oximctry screenings in detecting congenital heart disease early. Daniel Batlle, Public Witness, testified in support of the bill. The father of a child who suffered from an initially undetected congenital heart disease after birth, he stated that pulse oximetry testing is vital. For babies with undiagnosed congenital heart defects who otherwise appear healthy at birth, Mr. Batlle testified, a quick, non-invasive pulse oximtery test can save their lives and/or completely avoid traumatic emergency surgeries. Keri Sikich, Public Witness, testified in support of the bill. The mother of a child who suffered from a congenital heart defect 10 months after birth, Ms. Sikich expressed that pulse oximetry screening is vital for heart defects where early intervention is critical. Stephanie Wright, Public Witness, testified in support of the bill. The mother of a child who was born with half a heart, she stressed the importance of testing newborns for CHO. ''One simple test can drastically change the outcome of a baby's life" she testified. Tristan Wright, Public Witness and daughter of Stephanie Wright, echoed her mother's testimony. She stated that she has a pulse oximetry machine at home, which she uses whenever she's ill or her mother secs a change in skin color. Olivia Easely, Public Witness, testified in support of the bill. Ms. Easely gave birth to a child who died 7 weeks after birth due to Total Anomalous Pulmonary Venous Connection (TAPVC), a congenital heart disease. Had she been screened immediately after birth, she would have survived. Ms. Easely stressed that the symptoms of heart failure in babies are too non-specific; heart disease is, therefore, ripe for a delay in diagnosis, and a screening test like pulse oximetry is some babies' only chance for survival. Stuart Berlow, Director of Government Relations at the American Heart Association, testified in support of the bill. Mr. Berlow stressed that although prenatal ultrasounds and postnatal physical exams successfully detect many heart defects, and detection rates have improved since their advent, they are not sufficient to diagnose all cases of critical congenital heart disease. 6

7 Pulse Oximetry screening is a low-cost and painless test that, in conjunction with routine practices, can save many lives. He also stated that more than 40 states already recognize the critical need for this screening and require it to be performed after every birth in their jurisdictions~ including Maryland and Virginia. Dr. Mary Reven is, Chairman of the Fetus and Newborn Committee at the DC American Academy of Pediatrics, testified in support of the bill. Dr. Revenis stated that screening all newborns for lower oxygen levels with pulse oximctry will be good for babies and their families. Early identification of critical heart disease will reduce the risk of permanent injury or death, which happens with delayed identification. One recommendation that she offered was that any mandate should be flexible to allow for improved screening methodology. The standard for performing and evaluation the test should automatically change to reflect any updated American Academy of Pediatrics recommendations. Lisa Hom, Clinical Program Manager at the Children's National Heart Institute, testified in support of the bill. Ms. Hom helped to create the Congenital Heart Disease Screening Program in order help detect critical CHO while newborns are in the nursery. She stressed that screening should be a part of the standard of care at any hospital. Although it is often used, not all hospitals use the pulse oximetry test, which results in hundreds of babies going home with unrecognized critical congenital heart disease every year. Ms. Hom reiterated her support of the bill mandating early detection through the use of pulse oximetry following 24 hours of age and prior to discharge from the newborn nursery, and stressed the importance of screening all healthy newborns for congenital heart disease. Robert Malson, President of the D.C. Hospital Association, testified in support of the bill. He testified that this legislation is in line with the District's commitment to ensuring the best possible outcomes for patients. He stated that approximately 7,200 babies are born in the US with critical congenital heart defects, which can lead to low oxygen levels in the blood. Performing this easy and painless screening test can prevent further complications and save many lives. VI. IMPACT ON EXISTING LAW Bill 21-6 would impact existing law by adding a new section to the D.C. Official Code, which would require critical congenital heart disease screening for all newborn infants. VII. FISCAL IMPACT The attached fiscal impact statement from the Chief Financial Officer states that funds are sufficient in the proposed FY 2015 through FY 2018 budget and financial plan to implement the bill. 7

8 VIII. SECTION BY SECTION ANALYSIS Section I Section 2 Section 3 Section 4 Section 5 Section 6 States the short title of Bill Definitions Requires all newborns born in Washington D.C. to undergo screening by way of pulse oximetry or a another method as directed by the Department of Health Requires all health plans to reimburse for critical congenital heart disease screenings Adopts the fiscal impact statement States the Act will take effect following Mayoral approval and Congressional review. IX. COMMITTEE ACTION On Wednesday, April 2, 2015, the Committee on Health and Human Services met to consider Bill 21-6, the "Healthy Hearts of Babies Act of 2015". The meeting was called to order at 12:00 p.m., and Bill 21-6 was the first item on the agenda. After ascertaining a quorum, Councilmember Alexander opened up the floor for discussion. Councilmember Alexander moved the print and report separately, with leave for staff to make technical and editorial changes. The vote on the print and report was unanimous (Chairperson Alexander and Councilmembcrs Grosso and Nadeau voting "aye." Councilmember Chch was absent). The meeting adjourned at 12:05 p.m. 8

9 X. ATTACHMENTS I. Bill 21-6 as Introduced. 2. Hearing Notice and Witness List. 3. Copies of Written Testimony. 4. Fiscal Impact Statement. 5. Legal Sufficiency Memorandum. 6. Committee Print of Bill

10 ATTACHMENT 1

11 COUNCIL OF THE DISTRICT OF COLUMBIA 1350 Pennsylvania Avenue, N.W. Washington D.C Memorandum From : Nyasha mitli, Secretary to the Council Date : January 14, 2015 Subject : Referral of Proposed Legislation Notice is given that the attached proposed legislation was introduced in the Legislative Meeting on Tuesday, January 6, Copies are available in Room IO, the Legislative Services Division. TITLE: "Healthy Hearts of Babies Act of20l5", B INTRODUCED BY: Councilmembers Alexander, Grosso, Allen, Evans, Bonds, and Cheh CO-SPONSORED BY: Chairman Mendelson The Chairman is referring this legislation to the Committee on Health and Human Services. Attachment cc: General Counsel Budget Director Legislative Services

12 ,----" l 2 Councilme111ber 5ack Evans. 3 4 Councilmember Anita Bonds Councilmembcr Mar ' Cheh A BILL IN THE COUNCIL OF THE DISTRICT OF COLUMBIA Councilmember Charles Allen To require hospitals and maternity centers to perform critical congenital heart defect screenings JS on newborns using pulse oximetry prior to discharge BE IT ENACTED BY THE COUNCIL OF THE DISTRICT OF COLUMBIA, That this 21 act may be cited as the "Healthy Hearts of Babies Act of2015". 22 Sec. 2. The Department of Health shall require hospitals and maternity centers to 23 perform a critical congenital heart defect screening using pulse oximetry on every newborn born 24 at its facility prior to discharge. 25 Sec. 4. Fiscal impact statement. 26 The Council adopts the fiscal impact statement in the committee report as the fiscal 27 impact statement required by section 602(c)(3) of the District of Columbia Home Rule Act, 28 approved December 24, 1973 (87 Stat. 813; D.C. Official Code (c)(3)). 29 Sec. 5. Effective date. 1

13 Tilis act shall take effect following appro\'al by the Mayor (or in the event of \'elo by the 2 ~ 1ayor, action by the Council to override the veto), a 30-day period of Congressional review as 3 provided in section 602(c)(l) of the District of Columbia Home Rule Act, approved December 4 24, 1973 (87 SlaL 813; D.C. Orllcial Code l (c)(1)), and publication in the District of s Columbia Re_l,~Ster. (, 2

14 ATTACHMENT 2

15 Council of the District of Columbia Committee on Health and Human Services Notice of Public Hearing,,!350 Pennsylvania Ave., N.,V., Washi,ei;;ton, D.C,;,,20~04 11.ijf fl.. COUNCILMEMBER YVETTE M. ALEXANDER, CHAIRPERSON COMMITTEE ON HEALTH AND HUMAN SERVICES ANNOUNCES A PUBLIC HEARING on Bill 21-6, the "Healthy Hearts of Babies Act of 2015" Monday, February 2, :00 a.m., Room 500, John A. Wilson Building 1350 Pennsylvania Avenue, N.W. Washington, D.C Councilmember Yvette M. Alexander, Chairperson of the Committee on Health and Human Services, announces a public hearing on Bill 21-6, th1 "Healthy Hearts of Babies Act of 2015". The hearing will take place at 11:00 a.m. on Monday, February 2, 2015 in Room 500 of the John A. Wilson Building. The purpose of this bill is to require hospitals and maternity centers to perform critical congenital heart defect screenings on newborns using pulse oximetry prior to discharge. Those who wish to testify should contact Cory Davis, Legislative Assistant to the Committee on Health and Human Services, at or via at cdavis@dccouncil.us, and provide their name, address, telephone number, organizational affiliation and title (if any) by close of business on Thursday, January 29, Persons wishing to testify are encouraged, but not required, to submit 15 copies of written testimony. If submitted by the close of business on Thursday, January 29, 2015, the testimony will be distributed to Councilmembers before the hearing. Witnesses should limit their testimony to four minutes; less time will be allowed if there are a large number of witnesses. For those unable to testify at the hearing, written statements are encouraged and will be made a part of the official record. Copies of written statements can be ed to cdavis@dccouncil.us or to mailed to Cory Davis at the John A. Wilson Building, 1350 Pennsylvania Avenue, N.W., Room 115, Washington, D.C., The record will close at 5:00 p.rn. on Monday, February 16, 2015.

16 Council of the District of Columbia Conuuittee on Health and Human Services Notice of Public Hearing.1350 Pennsylvania Ave., N.W., Washieston, D.C M M COUNCILMEMBER YVETTE M. ALEXANDER, CHAIRPERSON COMMITTEE ON HEALTH AND HUMAN SERVICES ANNOUNCES A PUBLIC HEARING on Bill 21-6, the "Healthy Hearts of Babies Act of 2015" Monday, February 2, :00 a.m., Room 500, John A. Wilson Building 1350 Pennsylvania Avenue, N. W. Washington, D.C ''VITNESS LIST 1. Dr. Gerard Martin 2. Dr. Joseph Wright 3. Nancy Schoenfeld 4. Marie Pokraka Senior Vice President & Medical Director, Children's National Health System, American College of Cardiology Chair and Professor, Howard University Department of Pediatrics D.C. Academy Chapter of the American Academy of Pediatrics Chapter Director of Program Services, March of Dimes Panel One (#5-8) 5. Michelle Coleman 6. Katie Mooshian 7. Amy Shalawylo 8. Hilary Mehrkam Public Witness Public Witness Public Witness Public Witness Panel Two ( #9-12) 9. Meredith Atkinson Public Witness

17 10. Mirabel Atkinson 11. Daniel Batlle 12. Keri Sikich Public Witness Public Witness Public Witness Panel Three #(13-15) 13. Stephanie Wright 14. Tristan \Vright 15. Olivia Easely 16. Stuart Berlow 17. Lisa Hom 18. Dr. Mary Revenis 19. Joanne Adel berg 20. Robert Malson Public Witness Public Witness Public \Vitness Director of Government Relations, American Heart Association Clinical Program Manager, Children's National Heart Institute Chairman, Fetus and Newborn Committee of the DC American Academy of Pediatrics Chair, District of Columbia Committee on Metabolic Disorders President, D.C. Hospital Association Executive Witness 21. Ryan Springer Interim Director, Department of Health

18 ATTACHMENT 3

19 ~ Children's National~ Testimony of Gerard R. Martin, M.D., F.A.A.P., F.A.C.C., F.A.H.A. Senior Vice President, Center for Heart, Lung and Kidney Disease Medical Director, Global Services Children's National Health System American College of Cardiology Board of Trustees Immediate Past Chair, American College of Cardiology, Council of Adult Congenital/Pediatric Cardiology Committee Bill 21-6 Healthy Hearts of Babies Act of 2015 Committee on Health Council of the District of Columbia February 2, 2015 Good afternoon Chairperson Alexander and members of the Committee on Health and Human Services, my name is Gerard Martin, I am the Senior Vice President at Children's National Health System and a pediatric cardiologist with over thirty years of experience serving the children of Washington, D.C. Children's National is a 303-bed children's hospital that has been serving the Washington metropolitan region since Today I will also be representing the American College of Cardiology (ACC). The ACC is a 47,000-member medical society that is the professional home for the entire cardiovascular care team and whose mission is to transform cardiovascular care and improve heart health. Thank you for the opportunity to testify in support ofb21-6, the "Healthy Hearts of Babies Act of2015." Congenital heart disease (CHD) is the most common birth defect, impacting nearly 1 out of every 100 babies. The term "critical congenital heart disease" includes the most serious forms of CHD. CCHD affects 4 in 1000 babies born each year and is the leading cause of death for babies born with birth defects. In addition to the risk of death, failing to detect critical congenital heart disease in time can cause cognitive and developmental delays, leading to life-long disabilities. Pulse oximetry has been found to be an effective screening mechanism for CCHD in the newborn nursery. Pulse oximetry is a quick, inexpensive and painless test and usually takes less than 4 minutes to perform. The cost of pulse oximetry screening using a reusable probe is approximately 1 dollar, comparable to that of a diaper change. In September 2011, U.S. Secretary of Health and Human Services Kathleen Sebelius endorsed the addition of pulse ox screening for CCHD to the Recommended Uniform Screening Panel (RUSP) for all newborns nationwide. Currently, over 40 states require CCHD screening using pulse oximetry. At Children's National, we have successfully

20 worked with hospitals, state departments of health and foreign countries to implement CCHD screening programs in their nurseries. All of the hospitals in the District have chosen to implement CCHD screening programs in their organizations because they felt that it was simply the right thing to do. In 2013 we had the privilege of leading a quality improvement collaborative in the District with the support of the D.C. Department of Health and physician and nursing champions at each of the seven hospitals that deliver newborns. This collaborative was successful in educating nearly 300 physicians and nurses, getting the equipment into the newborn nurseries, ensuring adherence to the nationally endorsed protocol and developing appropriate follow-up policies for positive screens. Through our work in the collaborative, one issue was made clear: the need for a mandate to ensure that screening will be sustained and systematic. Knowing that most babies are being screened is not good enough. Required documentation and reporting to the Department of Health is the only way we can prove that no baby has slipped through the cracks. Through this legislation, all infants will have equal access to this quick, painless and low' cost test throughout the District. The team at Children's National looks forward to continuing the work we are doing with the D.C. Department of Health and other key local stakeholders to reduce preventable deaths and morbidity caused by undetected CCHD. As a final note, in March I will be participating in a work group put together by the American College of Cardiology, the American Academy of Pediatrics and the Centers for Disease Control. The purpose of this work group will be to examine new data from Europe and the United States that has become available since CCHD was added to the RUSP in As a result of our analysis, there may be changes to the current nationally endorsed algorithm that specifies the timing of when the screen should take place and what pulse oximetry values determine a positive screen. Therefore, I would caution against writing the specifics of the algorithm into the Act as changes to the nationally recommended algorithm may occur this spring. Thank you for the opportunity to testify regarding this important legislation. By working together, we can ensure that all the District's children get off to the healthiest possible start.

21 Jl Jl 1867 HOWARD UNIVERSITY Testimony of Joseph L. Wright, l\1d, MPH Professor and Chairman Department of Pediatrics and Child Health Ho,vard Universify College of Medicine Healthy Hearts of Babies Act of 2015 Bill Committee on Health District of Columbia City Council Monday, February 2,

22 GOOD MORNING, COMMITTEE CHAIR YVETTE M. ALEXANDER AND MEMBERS OF THE HEALTH COMMITTEE. I AM JOSEPH WRIGHT, PROFESSOR AND CHAIRMAN, DEPARTMENT OF PEDIATRICS AND CHILD HEALTH, HOWARD UNIVERSITY COLLEGE OF MEDICINE. ON BEHALF OF DR. WAYNE A. I. FREDERICK, PRESIDENT OF HOW ARD UNIVERSITY, IT IS MY PLEASURE TODAY TO PRESENT TESTIMONY ON BILL , "THE HEALTHY HEARTS OF BABIES ACT OF 2015". FOUNDED IN 1867, HOWARD UNIVERSITY IS A PRIVATE, RESEARCH UNIVERSITY THAT IS COMPRISED OF 13 SCHOOLS AND COLLEGES. STUDENTS PURSUE STUDIES IN MORE THAN 120 AREAS LEADING TO UNDERGRADUATE, GRADUATE AND PROFESSIONAL DEGREES. SINCE 1998, THE UNIVERSITY HAS PRODUCED TWO RHODES SCHOLARS, TWO TRUMAN SCHOLARS, A MARSHALL SCHOLAR, 30 FULBRIGHT SCHOLARS AND 11 PICKERING FELLOWS. HOWARD ALSO PRODUCES MORE ON CAMPUS AFRICAN-AMERICAN PH.D. RECIPIENTS THAN ANY OTHER UNIVERSITY IN THE UNITED STATES. 2

23 HOW ARD UNIVERSITY HEALTH SCIENCES IS PLEASED TO SUPPORT, "THE HEALTHY HEARTS OF BABIES ACT OF 2015". HOWARD UNIVERSITY HEALTH SCIENCES COMMENDS HEALTH COMMITTEE CHAIR YVETTE ALEXANDER AND COUNCILMEMBERS ALLEN, BOND, CHER, EVANS AND GROSSO FOR INTRODUCING LANGUAGE THAT, THROUGH THE DEPARTMENT OF HEALTH, REQUIRES BIRTHING HOSPITALS Ai' MATERNITY CENTERS TO PERFORM CRITICAL HEART DEFECT SCREENING USING PULSE OXIMETRY ON EVERY NEWBORN PRIOR TO DISCHARGE. THIS BILL REPRESENTS AN IMPORTANT PUBLIC HEALTH STEP FORWARD AND ALIGNS THE DISTRICT OF COLUMBIA WITH ITS REGIONAL PARTNER JURISDICTIONS, AS WELL AS, MOST OF THE REST OF THE COUNTRY IN ENACTING LEGISLATION THAT WILL SYSTEMATICALLY SAVE PRECIOUS YOUNG LIVES, AS WELL AS, INTRODUCE A FISCALLY RESPONSIBLE APPROACH TO THE EARLY DETECTION OF A SET OF CONDITIONS THAT HAS HERE TO-FORE BEEN MANAGED WITH POTENTIALLY DEV ASTAING OUTCOMES AND CATASTORPHIC COSTS. 3

24 CONGENITAL HEART DISEASE IS THE MOST COMMON BIRTH DEFECT AND AFFECTS APPROXIMATELY 8 PER EVERY 1,000 BABIES BORN EACH YEAR. MORE THAN 36,000 BABIES ARE BORN WITH CONGENITAL HEART DISEASE EACH YEAR IN THE UNITED STATES. WHILE TREMENDOUS ADVANCES HAVE TAKEN PLACE IN THE CARE OF CHILDREN WITH CONGENITAL HEART DISEASE AND SURVIVAL RATES ARE NOW APPROACHING 96%, CONGENITAL HEART DISEASE IS STILL THE LEADING CAUSE OF DEATH FOR BABIES BORN WITH A BIRTH DEFECT. IN FACT, THE AMERICAN HEART ASSOCIATION REPORTS THAT MORE THAN 30% OF INFANTS WHO DIE FROM A BIRTH DEFECT IN THE FIRST YEAR OF LIFE HA VE SOME FORM OF CONGENITAL HEART DISEASE. AN IMPORTANT ELEMENT OF THIS MORTALITY IS THAT A SIGNIFICANT NUMBER OF BABIES WITH CRITICAL CONGENITAL HEART DISEASE ARE NOT DETECTED IN THE NEWBORN NURSERY AND EITHER DIE BEFORE CARE CAN BE PROVIDED OR PRESENT IN POOR, COMPROMISED CONDITION BEFORE A CORRECTIVE PROCEDURE CAN BE PERFOMED. THIS MORTALITY IS 4

25 PREVENTABLE AND CAN BE ELIMINATED WITH AN EFFECTIVE SCREEN1NG PROGRAM USING PULSE OXIMETRY, SUCH AS PROPOSED IN THIS LEGISLATION. PULSE OXIMETRY (PULSE OX) HAS BEEN SHOWN TO BE AN EFFECTIVE SCREENING TEST TO DETECT CONGENITAL HEART DISEASE BEFORE BABIES LEA VE THE NEWBORN NURSERY. PULSE OX IS A QUICK, INEXPENSIVE AND NON-INVASIVE TEST THAT TAKES LESS THAN 4. MINUTES TO PERFORM. COLLEAGUES AT CHILDREN'S NATIONAL MEDICAL CENTER HAVE DEMONSTRATED THAT IMPLEMENTATION OF A NEWBORN PULSE OXIMETRY SCREEN1NG PROGRAM CAN BE ACCOMPLISHED WITH APPROPRIATE PROVIDER EDUCATION AND TRAINING. COMPREHENSIVE TOOLKITS HA VE BEEN DEVELOPED BY THE TEAM AT CHILDREN'S NATIONAL AND HA VE BEEN WIDELY UTILIZED ACROSS THE COUNTRY, AND INDEED, AROUND THE WORLD, TO INSTITUTIONALIZE THIS BEST PRACTICE APPROACH TO THE TIMELY TREATMENT AND DIAGNOSIS OF CHILDREN WITH CONGENITAL HEART DISEASE. 5

26 ALMOST 7 YEARS AGO, THE PATH TO TODA Y'S HEARING WAS LAUNCHED WITH A PHILANTHROPIC GIFT DIRECTED AT STUDYING THIS IMPORTANT CLINICAL ISSUE. AS A PUBLIC HEALTH ADVOCATE AND THE ACCOUNTABLE EXECUTIVE FOR THE NEWBORN SERVICES AT HOWARD UNIVERSITY HOSPITAL, IT IS PERHAPS MOST GRATIFYING TO ACKNOWLEDGE THAT THE MOST EFFECTIVE, SCIENTIFIC APPROACH TO PREVENTING THIS PROBLEM HAS NOW BEEN REALIZED. MADAM CHAIR, I'VE TESTIFIED BEFORE THIS COMMITTEE IN THE PAST ABOUT THE "THREE E'S" OF PREVENTION: >- ENGINEERING >- EDUCATION >- ENFORCEMENT IN TERMS OF 'ENGINEERING', THE TECHNOLGY OF PULSE OXIMETRY HAS BEEN PROVEN TO BE AN EFFICACIOUS AND RELIABLE TECHNIQUE, WITH THE ADDED ADV ANT AGE OF 6

27 BEING TOTALLY PAINLESS AND NON-INVASIVE. IN TERMS OF 'EDUCATION', IT HAS CERTAINLY BEEN DEMONSTRATED AND PUBLISHED IN THE PEER-REVIEWED MEDICAL LITERATURE THAT TOOLKITS AND TRAIN-THE-TRAINER METHODOLOGIES INTRODUCED TO BIRTHING ENVIRONMENTS CAN BE SUCCESSFULLY AND EFFICIENTLY ACCOMPLISHED. TODAY, WITH THE SYSTEMATIC 'ENFORCEMENT' OF A PROVEN BEST PRACTICE, THE THREE-LEGGED PREVENTION STOOL HAS BEEN SOLIDIFIED WITH THE ULTIMATE BENEFICIARIES THE BABIES AND FAMILIES OF THE DISTRICT OF COLUMBIA. AGAIN, ON BEHALF OF HOWARD UNIVERITY HEALTH SCIENCES, \VE SUPPORT THE "HEALTHY HEART FOR BABIES ACT OF 2015" AND PLEDGE TO WORK WITH DEPARTMENT OF HEALTH DIRECTOR, DR. LAQUANDRA NESBITT, AND HER STAFF IN ITS ROLL-OUT. THANK YOU. 7

28 District of Columbia Chapter American Academy of Pediatrics Council of the District of Columbia Committee on Health and Human Services Councilmember Yvette M. Alexander, Chairperson Testimony of Nancy Schoenfeld, Esq. Executive Director American Academy of Pediatrics, District of Columbia Chapter Bill 21-6, the "Healthy Hearts of Babies Act of2015" l\1onday,february2, :00 a.m., Room 500, John A. Wilson Building 1350 Pennsylvania Avenue, N.W. Washington, D.C Good morning. My name is Nancy Schoenfeld and I am the Executive Director of the District of Columbia Chapter of the American Academy of Pediatrics (DC AAP). I am here today representing more than 400 pediatrician members who are committed to the attainment of optimal physical, mental, and social health and well-being of all infants, children, adolescents, and young adults. The DC AAP strongly supports Bill 21-6, the "Healthy Hearts of Babies Act of 2015." Critical congenital heart disease or "CCHD" affects approximately 7,200 newborns every year in the United States and is one of the leading causes of infant deaths.' If not detected early, CCHD can have profound consequences on a child's life. However, pulse oximetry screening, which is readily available, noninvasive, and painless, can help detect CCHD in newborns. Pulse oximetry screening is inexpensive, with a recent study putting the cost of screening a newborn between $6 and ~7 and the incremental cost of screening at less than a dollar per newborn using reusable sensors. " Without pulse oxirnetry screening, CCHD is difficult to detect. Babies with CCHD can often have cyanosis or a bluish discoloration to their skin, however, when doing a clinical assessment, cyanosis can go unnoticed even by the trained eyes of a pediatrician or nurse because the human eye simply cannot detect or see the cyanosis until it has become very severe. Pediatricians call this window where they can't see the blue undertones the 'cyanotic blindspot.' Pulse oximetry testing helps give clinical staff one more way of identifying these babies early... because it can detect what the human eye can't see. Pediatricians also cannot rely on the

29 presence or absence of a heart murmur because most CCHDs do not present with a murmur and many newborns with a murmur often do not have CCHD. Another added benefit of screening is the detection of secondary targets (such as sepsis, pneumonia, infection and congenital diaphragmatic hernias) - other very serious illnesses which could also cause a baby to have abnormal oxygen saturation results. These conditions also can be detected by pulse oximetry. We don't want any baby going home with low oxygen levels in their blood without knowing the reason and providing appropriate care. In September 2011, the Secretary of the US Department of Health and Human Services (HHS) formally adopted the recommendation from the Secretary's Advisory Committee on Heritable Disorders in Newborns and Children to add CCHD to the Recommended Uniform Screening Panel (RUSP). iii Following this recommendation, the Advisory Committee, the American Academy of Pediatrics (AAP), the American College of Cardiology (ACC), and the American Hospital Association (AHA) issued "Strategies for Implementing Screening for Critical Congenital Heart Disease," which addressed critical issues such as necessary equipment, personnel, and training, and provided specific recommendations for assessment of oxygen saturation by using pulse oximetry as well as appropriate management of a positive screening result. iv In addition, the AAP issued a policy statement endorsing the decision of the Secretary of HHS to add critical congenital heart disease to the RUSP.' The AAP recommends the following: Screening should be conducted by using motion-tolerant pulse oxirneters that report functional oxygen saturation and have been cleared by the FDA for use in newborns. Screening should not be undertaken until 24 hours of life or as late as possible if early discharge from the hospital or birthing center is planned to reduce the number offalsepositive results. Considerations are necessary to ensure newborns born in home births are screened. Screening should be based on a recommended algorithm. Screening should be performed by qualified personnel who have been educated in the use of the algorithm and trained in pulse oximetry monitoring of newborns. Hospitals and birthing centers should establish partnerships with local and state public health agencies to develop strategies for quality assurance and to monitor the impact of screening Primary care physicians should ensure that newborns in their practice were appropriately screened following birth and should work to facilitate long-term follow-up for children diagnosed with CCHD. In addition, DC AAP recommends a requirement that screening be documented and reported to the DC Department of Health. With the Secretary's recommendation to add CCHD to the RUSP, the continued support of the AAP, the AHA, the ACC, and the various stakeholders in the District of Columbia, we ask

30 the committee to vote in favor ofbill 21-6, the "Healthy Hearts of Babies Act of2015." Thank you for your time. 1 United States Department of Health and Human Services, Centers for D'15ease Control and Prevention, National Center on Birth Defects and Developmental Disabilities. Screening for critical congenital heart defects Available at Accessed February 20, 2013., 11 Peterson C, Grosse SD, Oster ME, Olney RS, Cassell CH. Cost-effectiveness of routine screening for critical congenital heart disease in US newborns. Pediatrics. 2013;132(3): m Sebelius, Kathleen. Response adopting recommendation to add Critical Congenital Heart Disease to the Recommended Uniform Screening Panel Available at ' http :/lwww.h rsa. gov /advisoryco mm ittees/ m ch bad vi so ry/h er it a bl edisorders/ recommendations/ correspond en eel c yanoticheartsecre pdf. Accessed February 20, iv Kemper AR., et al. Strategies for implementing screening for critical congenital. Pediatrics. 2011;128(5):12S v American Academy of Pediatrics. Endorsement of Health and Human Services recommendation for pulse oximetry screening for critical congenital heart disease. Pediatrics, 2011;129(1):

31 State Advocacy American Academy of Pediatrics STATE ",-"\/ c P',,.,,,,,-1 1 -''! ~ L1 1\.t'Vi' 1' 1.4FFA.IRS q;.. I , x7799 I stgov@aap.org

32 STATE (~ 0 VERN lv1 ENT I , x7799 I stgov@aap.org AFFAIRS Cb Decembei 2014

33 I t:!::.lllllufly!ur Ult! nedluiy nedl L::. UI DdUlt:!::. f-\l.:l Ul.t.:U.l~ Hearing date: February 2, 2015 at 11:00 am I Room 500, John A. Wilson Building Name: Michele Coleman Telephone: Address: Washington, DC Affiliation: Private citizen I Mended Little Hearts of Washington, DC Dylan's story Good morning, thank you for inviting us here to listen to our stories and to clarify why we MUST pass the Healthy Hearts of Babies Act of My son Dylan, who is here with me today, is a beautiful example of how important this simple, inexpensive and non-invasive test is. He was given the chance to fight for his life because of Pulse Ox testing and this is our story. During a routine ultrasound at 13 weeks my Obstetrician found a spinal anomaly and because of this, we were followed at Children's National Medical Center for the rest of my pregnancy. We had every test and scan imaginable including four intensive sonograms and a fetal echocardiogram of Dylan's heart. Other than the spine, there was nothing of concern. All of the doctors agreed he was developing perfectly. Dylan was born in December 2012 at Holy Cross Hospital in Silver Spring, Maryland. He was full term, had good APGAR scores, and was eating and sleeping normally. After two routine days in the hospital, I was discharged and packed to go home. When we met with the Pediatrician that morning I thought Dylan would be discharged too, I could not have been more wrong. She instead informed us that Dylan had an abnormal Pulse Ox test which in his case meant that his oxygen saturation was 100% in his upper extremities and between 82% and 86% in his lower. We didn't even know what Pulse Ox was at the time. At this point the pediatrician was not overly concerned, but thankfully she followed the newly mandated Pulse Ox testing protocols and asked that we stay to have an Echocardiogram. Within 5 minutes of the Echo being completed Dylan was whisked away to the NICU and within 3 hours we were at Children's National Medical Center for immediate emergency surgery. 1

34 1 est1mony tor the Healthy Hearts of Babies Act of 2015 Hear"1ng date: February 2, 2015 at 11:00 am I Room 500, John A. Wilson Building Name: Michele Coleman Telephone: Address: Washington, DC Affiliation: Private citizen I Mended Little Hearts of Washington, DC Dylan was born with 3 CH D's that were repaired in open heart surgery at seven days old. Dylan had a tough recovery but like all CHD babies, was incredibly strong. He was in the hospital relearning how to breathe and eat for another two weeks and after 21 days we were released and headed home!! Dylan is amazing. He is a sweet and happy little boy who is thriving. If you didn't know his history or ever see his scars, you could never guess what he went through. He is considered "heart healthy", not on any medication, does not have restr"1ctions and only needs to see a cardiologist for annual check-ups. While all of that is very important to me personally, what should be important to you is that if I had delivered in Washington, DC where I live; this story could be very different. Pulse Ox testing was not being performed in hospitals when Dylan was born, and because he looked and acted so normal he would h_ave like_ly been discharged. We are told that without any medical intervention within 72 hours he would have died of congestive heart failure. Dylan was very lucky and we were very lucky. Even though we are DC residents, by a twist of fate I delivered in Maryland where just over 6 months prior to Dylan's birth, Pulse Ox testing became a mandatory part of the newborn screening. When Dylan was born, Pulse Ox testing was only mandatory in 17 states but as of today there are over 40 states where testing is mandatory and DC should be part of this number. As I have come to learn, Congenital Heart Defects are the most common birth defects in newborns. Nearly every 1 in 100 children born in the United States will have a Congenital Heart defect; that is nearly 40,000 bab 1es a year. And of that 40,000-7,200 will have a Critical CHD that can be caught with a simple pulse ox test and addressed immediately. 2

35 Testimony for the Healthy Hearts of Babies Act of 2015 Hearing date: February 2, 2015 at 11:00 am I Room 500, John A. Wilson Building Name: Michele Coleman Telephone: Address: Washington, DC Affiliation: Private citizen I Mended Little Hearts of Washington, DC Inspired by the gift that was given to me, I became the leader of a local non-profit called The Mended Little Hearts of Washington, DC which supports parents and caregivers of children with CH D's. I have sat with and talked to many of these families about their situations; some are uplifting and others are full of sorrow. While Pulse Ox testing cannot save all of the babies who are born with a CHD, and does not predetermine what their outcome will be, it does give those who need it a fighting chance. It gives the doctors the time they need for their medicine to work and to perform their miracles in the operating room. No baby should have to Jose a battle that should have been fought and no mother should have to grieve the loss of a child because they did not get a simple pulse ox test. As residents of DC, we are thrilled that in October 2013 all DC hospitals and major birthing centers voluntarily added the Pulse Ox testing to their standard screening, but we need YOU to go one step further. We need YOU to make sure that it is a requirement and that the protocols are in place to handle the abnormal screenings when they-occur. Welreed YOU to do the right thing and pass this law NOW. We need YOU to protect the new babies and their families in the District of Columbia. I cannot say this anymore loudly Dylan got a chance to live because of Pulse Oximetry testing. 3

36 Testimony for the Healthy Hearts of Babies Act of 2015 Hearing date: February 2, 2015 at 11:00 am I Room 500, John A. Wilson Building Name: Michele Coleman Telephone: Address: Washington, DC Affiliation: Private citizen [ Mended Little Hearts of Washington, DC 4

37 Testimony for the Healthy Hearts of Babies Act of 2015 Hearing date: February 2, 2015 at 11:00 am I Room 500, John A. Wilson Building Name: Hilary M Address: Washington, DC Affiliation: Private Citizen Many babies born with a critical congenital heart defects, like Lyla, can receive treatment and live a norm a I life if the defect is discovered in time, or they can die if the defect goes undetected. I urge the Council to require DC hospitals to provide this simple, inexpensive, and non-invasive test to all babies born in the District. In doing so, you will save lives. Thank you, t-i;;:_;-: 2

38 Testimony for the Healthy Hearts of Babies Act of 2015 Hearing date: February 2, 2015 at 11:00 am I Room 500, John A. Wilson Bu'ilding Name: Hilary M Address: Washington, DC Affiliation: Private Citizen My daughter, Lyla, was born with a serious heart defect called Transposition of the Great Arteries, or TGA. In short, with TGA the two main arteries of the heart are present, but they are connected backwards, which prevents the heart from being able to pump oxygenated blood to the body. Without intervention in the moments after she was born, and an open-heart surgery when she was just 5 days old, Lyla would have died, a thought I can barely bring myself to think about, much less speak. But Lyla's heart defect was corrected by surgery and she is now a healthy, energetic, and very curious 10 month old, who I expect to take her first steps any day. If it weren't for a few scars, one would never know of the battles she endured during the first 24 days of her life that she spent in the hospital. We will be eternally grateful for the excellent care that Lyla received by her team at Children's National Hospital. TGA is a rare heart defect, but it's not so rare that it didn't happen to us. And I quickly realized after Lyla's diagnosis that "rareness" and "rates o.f occurrence" mean nothing when it's your baby's life at stake. Setting aside TGA, generally speaking, heart defects are fairly common, affecting about 1 out of every 100 babies. Some heart defects are life threatening, some are not, most babies will live, some will not. But every baby deserves the best chance for survival and requiring DC hospitals to implement pulse ox screening is vital to saving those babies, like my daughter, whose lives literally depend on having their heart defect diagnosed shortly after birth. ----wewere-incredibly fortonate nrti-avelearnecrof Lyla'sneartaerectaurlng my pregnancy so we could plan ahead for herdelivery and open:heart surgery. Unfortunately, many times heart defects, including TGA, are riot discovered until after the baby is born. Sometimes it is apparentfo doctors shortly after birth-other times it is not and days may pass before_ symptoms are present indicating that the baby has a heart defect. A baby should not have to turn blue, and suffer possible organ damage, brain injury or death, before their heart defect is discovered when a simple reading of their blood oxygen level shortly after birth can alert dottors that something is not right. Shortly after learning of Lyla's heart defect, I asked nw Obstetrician whether she had previously encountered a baby 1Nith TGA.She\Nas qlliet for_a mi~ute, took a deep breath, and said that several year.sago she had delivered a baby with TGA. but that baby didn't survive. The heart defect hadn't been discovere d prenatally arid the condition wasn't apparent before the baby \Nas discharged from the hospital._ In. all likelihood, that baby's death would have been pre~ented had the DC hospitalbeen required to give the baby a simple pulse ox test. No other babies should die or suffer serious adverse health consequences because they aren't. provided with such a simple, non-invasive test after being born. 1

39 Testimony for the Healthy Hearts of Babies Act of 2015 Hearing date: February 2, 2015 at 11:00 am I Room 500, John A. Wilson Building Name: Katie M Address: Arlington, VA Affiliation: Private Citizen "Charlie's Story" Good morning. Thank you for the opportunity to share our story. Our third son Charlie was born at five a.m. one morning during the Thanksgiving holiday after a delightfully normal pregnancy. He was over eight pounds, beautifully pink, and feisty- as ready to welcome the world as we were to welcome him. On the surface it was a beautiful natural birth with a beautiful robust child. Charlie's Insides told a very different story. Charlie has Hypo-Plastic Left Heart Syndrome - essentially he wasbom with a half a heart. Our birth story is a positive one. Charlie was prenatally diagnosed at thirty-two weeks and we received fantastic coordinated care between Children's National and Washington Hospital Center. Without that pre-diagnoses there c:ould have been a very different story. In the middle of the night... in a busy urban hospital... during the holiday rush... in the middle of a flu epidemic... following a simple birth of a third time mom... there is absolutely no guarantee that a robust baby like Charlie would have merited a second glance. Certainly only a very keen and trained medicalprofessional would have thought to check his blood oxygen levels if they weren't required to do so. In order for a baby with Charlie's condition to survive long enough to undergo their first open -heart-surgery-they require a prostaglandinto be administered:-thismedicine-is-administered immediately following birth. It kept open a small duct in Charlie's heart to allow the oxygenated and de-oxyge~ated blood to pool and keep his blood oxygen levels at a survivable level until he was stable enough to have s_urgerj. The duct can close within a couple of hours or days. I was discharged from the hospital just four hours after Charlie was born. If we had not been prenatally dia-gnosed the_re_is goo-d likelihood that we would have gone home. If we had gone home, Charlie would have died. - Charlie is two-thirds of the way through a series of three palliative open heart surgeries to reconfigure his heart into the b~stpossible physiology. He is currently two years old and aside from some brief hospitalizations to help weather common bugs, he is thriving] Only those who know him well would even guess at all he's been through. We are so grateful for the lessons that life with Charlie has taught us. He has gifted his brothers with an incredible capacity for empathy and has opened our lives to amazing kindness and generosity. Give this gift to others. Please, vote for this critical legislation that will keep babies like Charlie from slipping through the cracks. Pulse Ox testing is inexpensive, non-invasive, and for babies like Charlie - life saving. Thank you. 1

40 Testimony for the Healthy Hearts of Babies Act of 2015 Hearing date: February 2, 2015 at 11:00 am I Room 500, John A. Wilson Building Name: Katie M Address: Arlington, VA Affiliation: Private Citizen Congenital Heart Defects; Give These Children a Chance 2

41 Testimony for the Healthy Hearts of Babies Act of 2015 Hearing date: February 2, 2015 at 11:00 am I Room 500, John A. Wilson Building Name: Tristan W Address: Woodridge, VA Affiliation: Private Citizen Pulse OX testing is very important because without it I would not be in the world. I am in the second grade, involved in Cub Scouts and I play ice hockey. Not most hypoplastic kids play ice hockey. We have a pulse ox machine at home, and my mom tests me if she sees changes in my skin color or if I don't feel well

42 Testimony for the Healthy Hearts of Bab'ies Act of 2015 Hearing date: February 2, 2015 at 11:00 am I Room 500, John A. Wilson building Name: Keri s Address: Washington, DC Affiliation: Private Citizen J Mended Little Hearts of Washington, DC Good morning Committee Members. I am here today to express my support for Bill 21-6 the Healthy Hearts of Babies Act of 2015, which would require hospitals and birthing centers to perform congenital heart defect screening using pulse oximetry testing on every newborn before he or she could be discharged. I'd like to thank the committee for holding a public hearing on this issue and thank Council members Alexander, Grosso, Allen, Evans, and Ch eh for introducing this important legislation. I am a resident of the District and have lived in Ward 3 for 13 years. I am also a mother of two boys, both of whom were born in DC at Georgetown University Hospital. My son, Luke, is 5 years old and my son, Mark, is 2 years old. It is my son, Mark, who brings me here before you today. Mark was born complication-free on September 21, We wouldn't find out until about 10 months later that he had a congenital heart defect. Although he exhibited what we now know as classic symptoms of a congenital heart defect-. such --. as profuse sweating while nursing- we didn't know that it was a sign thaf.somethini was wrong. rt wasn't u'ntil our pediatrician noticed a heart murmur at his 9 month ~heck-up and refe~red us to a peaiatric cardiologist that we discovered that he had'~ large atrial}ept~i ci~f~ct. He had bpen heart surgery at Children's National Medical Center in September2013 to repair his heart. Mark's story is about as uncomplicated as it c~n get for a child wlth a congenita(heartdefect. He was diagnosed, he had surgery, and he is fully recovered. We're one of the lufky o~es. However, Mark's story exemplifies the dangers of congenital heart defects. Parents do not know the signs of a congenital heart defect ~o they aon't knoiiwhen s6;,,~thl~g J1llght be. wrong. Pulse oximetry screening is vital for thrise hea_i'tdf!fects where~arlyintervehtion is critical. I don't believe Mark ever had pulse oximetry testi~g inthehospltal aiterhe i'jasbom. Fortunately for us, his heart defect wasn't on~that is fatal if not di~gn~~~ci;6cin'~fter.birth : ,..: ~- _-_ Before having a child with a congenital heartaefec::t, I really knew nothini'aboutth~m:... However, congenital heart defects are the mdlt common birth def~ifs cahdtan affoctany child. They affect 1in110 children. Yet, there's nothlng thatcan p~epare yo~ f~rthat.f11of11~nt that you are told your child needs to have open heartsurger)'. I cannot imaglneho~ par~ritsfeel if they lose a child to a con gen ital heart defed 'anc:i find out later that a simple test could have saved their child's life. 1

43 Testimony for the Healthy Hearts of Babies Act of 2015 Hearing date: February 2, 2015at11:00 am I Room 500, John A. Wilson building Name: Keri S Address: Washington, DC Affiliation: Private Citizen 1 Mended Little Hearts of Washington, DC I am here to urge you to support and adopt this legislation. This simple screening that literally takes seconds to perform and is virtually costless will save babies' lives. I'm confident that all District residents will care about this screening once they become aware of it. 1 can't tell you how many people who 1 have told about pulse oximetry screening, not just those who live in DC, whose first question to me is "how can 1 found out if my state requires this testing?" The Council has taken this important first step by introducing this legislation. Although hospitals are currently voluntarily complying with the screening, it is time to put the force of the law behind it. Thank you for your time. Act! ' MOiii<.ai.>wOIMI! "D>\O'.liot('>"' ""'""'""'m'"'~' "' ---- '" r :_:::.: m 2

44 Testimony for the Healthy Hearts of Babies Act of 2015 Hearing date: February 2, 2015 at 11:00 am I Room 500, John A. Wilson Building Name: Mirabel Atkinson Address: Washington, DC Affiliation: Private Citizen Good morning, my name is Mirabel Atkinson and I am 10 years old. I was born with congenital heart disease. I've had 3 heart catheterizations and 3 open-heart surgeries. When I was born, my oxygen saturation level was about 81%. This was something the doctors could tell from the pulse-ox machine, which I like to call Rudolph because it has a bright red light that looks like Rudolph's red nose. It doesn't even hurt to wear it. I think that pulse-ox screening is important because it can tell if someone has congenital heart disease and help them get the treatment they need in time.

45 Testimony for the Healthy Hearts of Babies Act of 2015 Hearing date: Februany 2, 2015 at 11:00 am I Room 500, John A. Wilson Building Name: Meredith Atkinson Telephone: Address: Washington, DC Affiliation: Private Citizen Thank you for the opportunity to share our story today. My name is Meredith Atkinson and I'm the mom to 10-year-old twins, Mirabel and Sofia Atkinson, and a 20-year resident of DC. Mirabel was actually born with several highly complex congenital heart defects and is considered a single-ventricle heart patient. Due to my complicated twin pregnancy, Mirabel was diagnosed in-utero. But had she been a singleton, it's likely she would have gone undiagnosed and she might not be here today. Her heart is missing a right ventricle, her two main arteries are backwards, she's missing her tricuspid valve, and she has a number of holes. This required medicine immediately after birth and surgical intervention within several months in order to ensure her survival. Like Mirabel said, she was born with a blood oxygen saturation level of about 81%, but through her various surgeries and catheterizations, her heart was rearranged so it could function better. And with all of that, her blood oxygenation improved so that she's now around 95%, and more importantly, she can live a relatively full and normal life. Congenital heart disease is the number one birth defect, occurring in about one out of every 110 babies, and pulse-ox screening in newborns is a prime indicator for this disease. Mirabel was born with one of the most challenging congenital heart defects. And yet, with each of her open-heart surgeries, we were told there was about a 98% survival rate. Kids with heart defects can survive. But children with congenital heart disease like Mirabel have to be diagnosed early in order to have positive outcomes like hers. Pulse-oximetry screening is simple and non-invasive. It requires a Band-Aid-like device to be wrapped around a baby's foot for only about a minute. A reading then comes up on the monitor letting doctors and nurses know the child's blood oxygen saturation levels. And the machines themselves cost only about $30. I strongly urge you to support the "Healthy Hearts of Babies Act of 2015" so that all children born in DC will be given pulse-ox screenings, and all babies born with congenital heart defects will be given the same chance that Mirabel has had. Thank you.

46 Testimony for the Healthy Hearts of Babies Act of 2015 Hearing date: February 2, 2015 at 11:00 am I Room 500, John A. Wilson building Name: Ann and Dan Batlle Address: Kensington, MD Affiliation: Private Citizens Although many congenital heart defects are discovered in utero -- generally at the 20- week anatomy scan -- we were among the portion of the population who make it through an entire, well-monitored pregnancy without knowing that there is anything wrong with our child. We received otherwise high-quality medical care from well-known doctors yet this defect nonetheless went undetected during our pregnancy. We believe that Eva being overdue both contributed to her emergency condition at birth, but also to her being rapidly diagnosed. We have since learned that many transposition of the greatartery cases can be in children who are born under normal conditions with no known signs of distress, and who are sent home from the hospital on schedule. Those children can suddenly turn blue or show distressed breathing up to several weeks after being at home. One can only imagine the terror of parents who thought they had brought home a healthy baby who are now calling 911 and fearful of what has gone wrong. For babies with undiagnosed congenital heart defects who otherwise appear healthy at birth, a quick, non-invasive pulse oximetry test can save their lives. Traumatic emergencies can be completely avoided by testing these infants in the hospital, rather than sending them home and depending on the kind of tight sequencing of available ambulances, quick-thinking diagnoses and rapid surgery that we required to keep Eva alive. We are grateful every day for our healthy daughter and would not wish on any parent the traumatic circumstances of her birth or emergency surgeries. We therefore urge the Council to support required pulse ox testing for every infant born in a DC hospital. Thank you for the opportunity to share our testimony with you. Ann and Dan Batlle Connecticut Avenue Kensington, MD

47 Testimony for the Healthy Hearts of Babies Act of 2015 Hearing date: February 2, 2015 at 11:00 am I Room 500, John A. Wilson building Name: Amy S Address: Woodbridge, VA Affiliation: Private Citizen My name is Amy Shalawylo. My son, Zeke, was born with Down Syndrome and a congenital heart defect known as Atrioventricular Septal Defect. These were both detected at a 21-week prenatal ultrasound. Our situation was slightly different in that, as a newborn, we already knew that Zeke would require Pulse Oximetry screenings (as well as other tests) to ensure that he remained stable in his first hours and days of life. Pulse Ox readings gave us great insight into how Zeke's heart was functioning as his ductus arteriosus closed (as.it does for all babies) and his lungs took over the work of supplying the oxygen. Our cardiologist informed us that at about 4-6 weeks old, Zeke's blood pressure would be evening out and this could cause problems for him because of the defect. She also told us signs to watch out for because, more than likely, Zeke would need to be on medicine to help his heart until the repair surgery. We took Zeke in for his routine one month checkup with our pediatrician. After exhibiting very few signs of any distress, I asked the pediatrician to take a Pulse Ox reading just out of curiosity. The doctors, my husband, and I were all shocked to see a reading of 76. His norm had been in --the high 80'sup-untilthat-point-and-we-were-anticipatingaperfect100 after his-repair- surgery; The pediatrician advised us to go admit him to the hospital for monitoring immediately. Had the Pulse Ox not been taken, we may have overlooked some signs and Zeke's health could have taken a scarier decline if the circumstances were different. Though this situation was anticipated and even predicted, we caught it at the first moment possible. Knowing a simple Pulse Ox reading can help parents and doctors make quick decisions regarding their baby's health when few or no other signs of distress are exhibited. It is noninvasive and gives not only accurate information, but peace of mind to parents. When you are the parent of a child with Congenital Heart Disease, peace of mind is priceless. Thank you for your time and consideration of the Healthy Hearts of Babies Act!

48 Testimony for the Healthy Hearts of Babies Act of 2015 Hearing date: February 2, 2015 at l,1:00 am I Room 500, John A. Wilson building Name: Ann and Dan Batlle Address: Kensington, MD Affiliation: Private Citizens We write to you today in support of mandatory pulse oximetry testing for all newborns born at District of Columbia hospitals. This is an issue very near and dear to our hearts. Our daughter, Eva, was born in July Although we are Maryland residents, we were under the care of an OB/GYN practice in DC and, like many other residents of close-in Montgomery County, delivered our child at Sibley Hospital in DC. Because of an undiagnosed congenital heart defect, Eva ultimately received emergency treatment at three different DC hospitals within five hours of her birth. We had an uneventful, healthy pregnancy and were expecting a routine delivery at Sibley. However, Eva was nine days overdue and we ultimately had to move labor along with a scheduled induction. Soon after the induction medications were administered, Eva's heartbeat started to slow down - our first indication that something might be wrong. Induction ceased forthe night, and restarted the next morning. Again, her heartbeat deteriorated quickly after medications were administered, and after just a couple hours of monitoring and early labor, our OB/GYN made the life-saving call to deliver her by emergency Caesarean section. We knew we were in a very serious emergency when she was delivered within ten minutes of the doctor's call for a ( section, in an operating room which had rapidly filled with many additional hands on deck Eva was born blue and was not breathing. The doctors in the OR seemed to think there was a lung issue, perhaps even meconium aspiration. However, she did not respond to suctioning and she was quickly put on a jet ventilator. Within an hour of b'1rth, she was rushed by ambulance to Georgetown Hospital, where a cardiologist quickly diagnosed her with a congenital heart defect -- transposition of the great arteries. Essentially, because her aorta and pulmonary artery were in the wrong positions, her heart functioned as two closed circuits, and no newly oxygenated blood was able to circulate in her body. She continued to deteriorate rapidly. Eva was transferred again by ambulance to Children's Hospital for an emergency catheterization procedure to open a duct in her heart to permit oxygenated blood to freely circulate. Based on conversations we later heard from hospital staff at each hospital, it became clear to us that we very nearly lost her that day. In fact, the tight sequencing of ambulance transfers, rapid diagnosis and catheterization required to keep her alive is nothing short of miraculous in our eyes. One week after arrival at Children's, when she was 7 days old, Eva underwent a successful open heart procedure to correct the transposition -- removing and reattaching her pulmonary artery and aorta into the right position. She came home on day 13 and has thrived ever since. Eva is a delightful, happy, active and healthy kindergartener, with no restrictions on her activities and an excellent long-term prognosis. Other than her tell-tale "zipper" scar, one would never guess what she survived in her first days after birth. 1

49 Testimony for the Healthy Hearts of Babies Act of 2015 Hearing date: February 2, 2015 at 11:00 am I Room 500, John A. Wilson Building Name: Stephanie W Address: Woodridge, VA Affiliation: Private Citizen Good Morning! Thank you for allowing us the time to speak on why pulse ox testing in newborns is important to us. Tristan was born with what is called Hypo plastic Left Heart Syndrome in a Maryland Hospital in 2007, well before they started testing. We were not pre-diagnosed, so we were expecting a healthy baby boy. Upon Tristan's arrival he was a little grey and didn't really cry. He was given an 8 and a 9 for his Apgar scores. The only noticeable defect was that his ring fingers and middle fingers were stuck together on both hands. He has what is known as bilateral polysyndactlism. After he fed the first time and before they took him back to give him a bath, my husband notice his rapid breathing. He told the nurse and she said he was ok, that (-section babies do this. So, he was hooked up to a heart monitor and because of the openings in the patent duct us arteriosus and the patent fora men ova le, his heart rhythm was normal. He continued with the rapid breathing and we were told again it was normal. After about 9 hours he wouldn't wake up for his third feed of the day. We tried everything to wake him up but it just wasn't happening. The nurse's aide came into our room to try and help us and that's when things started happen. She gave Tristan a bottle while he was in nothing but his diaper. Tristan aspirated on the _f_c>~m_u la and she quickly took him ~o_ttie nursery to be evaluated At this time we were ok with him being evaluated because we had been told that (-section babies tend to swallow amniotic fluid. After some time, we were told that Tristan did in fact have fluid in his lungs and he was going down to the NICU to be treated. We said ok, do what you need to do to get him healthy. It wasn't until they got him down there and hooked up on the monitors and the PULSE OX machine that they realized something was very wrong with him. His 02 saturation was only 67. At just over 16 hours old we were told that Tristan was born with half a heart and he was going to Children's in D.C. for open heart surgery or he was going to die. Knowing then what we know now, things could have been a whole lot different had he been hooked up to a Pulse Ox just after birth. Being oxygen deprived for that long could have serious impact on his brain function. Lucky he doesn't suffer too much. He does however have Executive Function Delay and Executive Recall issues. Tristan underwent his first of three open heart surgeries at just 7 days old. His next one was at 5 months and his third was at 18 months. We are very fortunate that Tristan is able to 1

50 Testimony for the Healthy Hearts of Babies Act of 2015 Hearing date: February 2, 2015at11:00 am I Room 500, John A. Wilson Building Name: Stephanie W Address: Woodridge, VA Affiliation: Private Citizen live a normal life with such a complex heart defect. It is important to us that other families do not have to go through what we went through after birth. With one simple test thousands of babies lives could be saved a year. The CDC reports Congenital Heart Defects are the most common birt_h defect. 1 out of every 4,344 babies born in the United States each year is born with hypoplastic left heart syndrome and 1 in 4 babies are born with a Critical Congenital Heart Defect. By testing newborns, babies can get the treatment they need in order to survive. One simple test can drastically change the outcome of a baby's life. Although it happened 15 hours after Tristan was born we are standing here today to tell you first hand that he would not be here with us had he not been tested

51 Testimony for the Healthy Hearts of Babies Act of 2015 Hearing date: February 2, 2015at11:00 am I Room 500, John A. Wilson Building Name: Stephanie W Address: Woodridge, VA Affiliation: Private Citizen 3

52 Testimony for the Healthy Hearts of Babies Act of 2015 Hearing date: February 2, 2015at11:00 am I Room 500, John A. Wilson Building Name: Stephanie W Address: Woodridge, VA Affiliation: Private Citizen 4

53 Testimony for the Healthy Hearts of Babies Act of 2015 Hearing date: February 2, 2015 at 11:00 am I Room 500, John A. Wilson Building Name: Stephanie W Address: Woodridge, VA Affiliation: Private Citizen 5

54 1 ~!il1mony ror tne Healthy Hearts of Babies Act of 2015 Hearing date: February 2, 2015 at 11:00 am I Room 500, John A. Wilson building Name: Olivia Easley, M.D. Address: Potomac, MD Affiliation: Private Citizen Re: Support for mandatory pulse oximetry screening for critical congenital heart disease for all infants born in the District of Columbia Honorable Committee Members: I am speaking today on behalf of my daughter, Veronica Jane Easley, who died suddenly and unexpectedly in June, 2009, of undetected critical congenital heart disease. I believe that the data in support of neonatal pulse oximetry screening speak for themselves and I will not reiterate them. I am here to provide a face to the tragedy of missed diagnosis of critical congenital heart defects. Veronica, my third child, was born on April 29, 2009, and was seemingly perfect. Her APGAR scores were 8 and 9, and she weighed 8 lbs 7 oz. According to her hospital discharge physical examination, she was "a perfectly healthy newborn baby girl." And at the time, there was no reason to think otherwise. Except for experiencing newborn jaundice that resolved by 10 days, Veronica thrived during the first month of her life. She was eating well, her color was good, and she had gained one pound by her 4 week check up. At six weeks of age, Veronica began to develop some difficulty feedin more o ten, seemed uncomfortable while nursing, and vomited on two occasions. However, being a third time mom, none of those symptoms were particularly alarming. My older children both had reflux and were not the easiest babies to feed. I spoke with my pediatrician's office and was advised that perhaps Veronica was intolerant to something in my diet. A couple of days later, when her feeding difficulty persisted despite modifications in my diet, I scheduled an appointment with her pediatrician. Sadly, we never made it to that office visit. The night before the appointment, on June 18, 2009, Veronica died suddenly at home. She was 7 weeks old. An autopsy conducted the following day at the Maryland Medical Examiner's Office found that Veronica had died from a critical congenital heart defect -'total anomalous pulmonary venous connec~.ion (TAP\/C).with. an atrial septa I d,efe,ct (ASD ). ft,11 four pulmonary veins returned directly to her right atrium instead of tier left, and her heart was nearly four times the normal size.

55 Testimony for the Healthy Hearts of Babies Act of 2015 Hearing date: February 2, 2015 at 11:00 am I Room 500, John A. Wilson building Name: Olivia Easley, M.D. Address: Potomac, MD Affiliation: Private Citizen I was beside myself. I had no idea she was critically ill-she never was cyanotic, her breathing was never labored, and she had been gaining weight appropriately. After she died, I read about the symptoms of heart failure in babies; she had only one - difficulty feeding. It never crossed my mind that this mild and non-specific symptom could have been a sign of a life-threatening anomaly. I was devastated to learn that Veronica's specific defect was not a death sentence and, if detected, is amenable to surgical treatment with long-term survival rates of 85%. When I was pregnant with Veronica, I had had perfect pre-natal care, including a 20- week ultrasound performed by a highly respected maternal fetal medicine specialist. did not know, however, that pre-natal ultrasound misses more than two-thirds of major congenital heart defects. 1 I was also unaware of the fact that congenital heart disease is the most common birth defect and occurs in 1in125 live births.ii Veronica's heart was a ticking time bomb. The symptoms of heart failure in babies are too non-specific; heart disease is, therefore, ripe for a delay in diagnosis. Veronica's disease escaped detection by me, my husband, my extended family, my perinatologist, the newborn nursery nurses, and finally, by her own pediatricians. A screening test like pulse oximetry was her only chance. I would give anything to turn back the clock and demand that that simple and inexpensive test be performed on my l:><i_t!y_gi.l[. PerhaQs she~jght be alive today. I hope you will support a bill to require newborn pulse oximetry screening for critical congenital heart disease and help to prevent other families from experiencing the tragedy that ours did. Sincerely, Olivia Johnson Easley, M.D. 'Friedberg MK, Silverman NH, Moon-Grady AJ, Tong E, Nourse J, Sorenson B, et. al. Prenatal Detection of Congenital Heart Disease. J Pediatr July; 155 (!): ii Congenital Heart Defects. Retrieved January 20, 2010, from the March of Dimes website: http ://marchofdimes.com/professionals/i asp 2

56 1esr1monyrortne Heaitny Hearts ct Babies Act of201s Hearing date: February 2, 2015 at 11:00 am I Room 500, John A. Wilson building Name: Oliv ia Easley, M.D. Address: Potomac, MD Affiliation: Private Citizen ~ vero'ilica Jane ea51ey, 4129/09 - s11 s109 3

57 ~!;!,~ m '" Hospital Association >'st're~t. Nw Suite 900 Washington, DC Tel: (Office) 202/ Fax: 202/ Web: Testimony before the Council of the District of Columbia Committee on Health and Human Senices on B21-6 the "Healthy Hearts of Babies Act of 2015" * * * Presented by Robert A. Malson J?reside_nt.. February 2, 2015 Children's National Medical Center George Washington University Hospital Howard University Hospital Malcolm Grow Medical Clinic and Surgery Center, Joint Base Andrews, MD MedStar Georgetown University Hospital MedStar National Rehabilitation Hospital MedStar Washington Hospital Center Providence Hospital Psychiatric Institute of Washington Saint Elizabeths Hospital, D.C. Department of Mental Health Sibley Memorial Hospital Specia!ty Hospital of Washington - Capitol Hill Specialty Hospital of Washington - Hadley United Medical Cent er Veterans Affairs Medical Center Walter Reed National Military Medical Center

58 Good Morning Chairwoman Alexander and members of the Committee on Health and Human Services, my name is Robert A. Malson and I am President of the District of Columbia Hospital Association (DCHA). I appreciate the opportunity to present testimony on behalf of our hospitals in support of B21-6, the "Healthy Hearts of Babies Act of 2015." As you know, DCHA is a non-profit organization with 16 member hospitals and 31 associate members whose mission is to provide leadership in improving health care in the District of Columbia. DCHA members employ approximately 26,000 individuals who are on the front lines for delivering quality health care and responding to any medical emergency in the District of Columbia. Currently, the Department of Health requires two screenings for ----n-ewbems-pfior-tb-eliseharg&.--babies-in-the-di-str-i t-untlergo-metabelie-elisertlef~---- testing as well as a hearing screening prior to discharge and the pulse oximetry, or pulse ox, test would be added to this list through this bill. The aim of these tests is to ensure health issues are identified early in a baby's life to allow doctors to begin treatment quickly to preserve the health of the most vulnerable District residents. As you are aware, B21-6 directs the Department of Health to require all hospitals and maternity centers to administer a pulse ox test on newborns in the District prior to discharge. The pulse ox test is a simple test that allows doctors to identify possible congenital heart defects that a baby may possess. According to 2

59 the Centers for Disease Control and Prevention, approximately 7,200 babies are born in the United States with a critical congenital heart defect. These defects can lead to low oxygen levels in the blood after 24 hours after birth and can be detected by a pulse ox test, which can be easily and painlessly done at the bedside. DCHA's member hospitals are dedicated to ensuring the best possible outcomes for patients and believe this legislation is in line with that commitment. Thank you for letting us provide comments in support of this legislation and I welcome any questions you may have on this issue

60 >:' ;;.;,, - - ~ Q.. AmericanfAmerican c 'Heart I :.stroke.. --~-- '-i : ;"lif~fs\vhyin:~... Assoi:iaiiolr 'Association~. _.. :.,- _,,.. "". '!-_ ;_ _ -.- ~ - - >Testirifolly oftheain~rlcan He~rtAss'ociaiion ' st1 art Berlow/Direcfoftif G~.v~i'riment R~IaHons _. DC c6~ncll Corrlniirt~~ ~n Health ~n d Hrtiiian S~nrices 1321.:-6:B:eaftliy:Heari8-oi:Babies"A~i0Iiofs : i ~.e~r!l~i'; 2, 1ois.. _ _~). ; Chairperson Alexander and rn:~mb~r's 6f the Committee,: the American Heart Association thanks you for so quickly hearing testimony on this lifes.aving legislationhefore you today: the Health}rHeaHs of Babies Act of2015. Thislegislatiori,will require all District hospitals to perfo"iiri'~ritical coli.genital heart defedscr~ening using pulseox"imetry for all babies borii in the District of Columbia before discharge. Quite simply, this legislation will save llves. ' , ~.;' Congenital he~ defects are malformations of the heart or major blood vessels that occur before birth. In many Cases, hospital stfilfmay:not identify these defects arid lis a' result, infants V,,lio appear 6utWari:llyhealthyrriaybe'disch~rgeC! fronihospitals beforesigris of disease are deteet~d. -' " " : " Collgehlt~l ne'kt\fefeets ()ccuf j.n 8 Out 6f eveiy "i,000 blrths:th~yare the most co\rullop c8.µ~e 9fllif arit death, accoun1.mgfcir 2 7% ofllffant deaths"ihai ate... caused liy l:iirth'c!efe~ts,... ' -.,... _ - -,' :,.'.-;, ~ :, I... / ' _,2_,5;+()%.o'fin :wiio'. ~.V~oo~nitati,iafi-B~~~~e-_dia~ soo.:w-itik-i-it-iea! c9hge~fo11ieartdis~ase- (CCHD), a Jife'fureat'enin'g ~onditloiii:hat req~ires _. _-. sli;,gery- sratlief irrterveriiioii."failur~ to :detect cchb E&C! late <leteciion ()f cchb often leads to death. fherec~te'6,06o'<l~~fus intn{us each year attributable tocbngerutal heart.'. H~fectf, iric1~ciiji20oa;s'5tiate<l' with missed or 1afo diignosis of cc@, -_. M.ore.tha.ilh:ilf 0 iiatieriiswith a iiii.ssed 'c.iiagi!osi~ w!l(di~ betote the-ii heart c di~;{gs~i{{e og{ii~~a... ' " '.... '' ~< --" ~--' Althoughpreriata]ultrasounds.a,nd postnatal physical exams successfully detest many _. :~if~~~~~tl:l~~~~~~;~~it:i!illf#~t over mover 90% of newborns "":;:<:_ 'J\-~-, ~; ;; c~ - i,c,_,_-, --.~.--::.-- - ;_;':;u - --,-- - ~-~-.. _,_,_ ~h~tgt~;i~tf ~i~~~~~1~li1iff~tin~f:ithi!~\y%s~~12~~~wril~ 1 g~~~~~~i~i~~! conducted to estimate the percentage of hemoglobin ih ihe'b1o6d' that is aforated ~itli.. oxygen. The presence qf!my saturnt.ion triggers ac!dit\onal testing to detect heart defects or other life-thr'eatening-conditions. The test is fypicall{p~rfotriled hei.w~en'24~,fa h'ours " ; _- - - _--.; -~-.; -:~.-;~:.:;:,-=-"':~_'-:''.. ~.~'.~-~;-~; ;"f,.::~_:;tj,_- :.;:~ -- "Building healthier Wes, free of c~rdiovascuiar dise~sd a/lcf stroke." life is why es por la vida ~~-~ffrf"" - -..,,_,_:-;.,-_".- ;:;1;;,,.~e r~r> ;:n: <"~ t.-:e ft~:.~r;~~;; f-'~:jt",,_.~~qci.:!lo:>" i!;yc;;.~w!i!.

61 after birth, with a sensor placed on the skin. It is painless and costs only between $5-10. Again, this simple screen saves lives. It also saves precious healthcare dollars. In 2004, hospital costs associated with congenital heart defects totaled $2.6 billion in the US. CCHD screening with pulse oximetry has been endorsed by the US Department of Health and Human Services, as well as leading health organizations represented here today, including the American Heart Association, American Academy of Pediatrics, March of Dimes, American College of Cardiology, and Children's National Medical Center. Approximately 14,000 babies are born annually in the District of Columbia, and up to 35 may be born with CCHD. By enacting this legislation, and requiring pulse ox to be performed on all newborns in the District, this Committee and the Council will increase the likelihood of survival, preventing parents and families from facing unspeakable loss. More than 40 states already recognize the critical need for this screening and require it to be performed after every birth in their jurisdictions - this includes our neighbors Maryland and Virginia. The District lags woefully behind the rest of the country, and we urge the Committee to swiftly move this legislation to ensure that lives are no longer at risk because a simple, inexpensive, painless test is not required to be performed. It is our understanding that every hospital in the District with a birthing facility currently performs pulse ox screening voluntarily. Like so many other newborn screens, the District's physicians recognize the medical necessity of CCHD screening with pulse ox and routinely perform it. However, without a requirement in place, hospitals are free to stop CCHD screening at any time, for any reason. Moreover, without a statute, there is no data currently being reported to the Department of Health. All of the District's hospitals Hy-necessary;it savesiive~-, and costs virtually nothing. There's no reason not to perform a pulse ox test, and we urge the Committee to codify this screening protocol, like so many other newborn tests. The American Heart Association is committed to working with hospitals, physicians, the Department of Health, and all stakeholders to ensure effective, rapid implementation of CCHD screening protocols in the District. We are confident that since all District hospitals currently perform the screen and since over 40 states have wisely begun their own programs, this will be a seamless process that will save lives in Washington, DC. We thank the Committee for your commitment to the health of all residents of our nation's capital, particularly our most vulnerable residents - newborns. We urge swift consideration and markllp of this legislation, and ask the Committee to vote favorably. Rarely do our lawmakers literally have the opportunity to save lives through legislation. However, by ensuring that pulse oximetry screening is performed on all 14,000 babies born in Washington, DC each year, this Committee and this Council will save lives, prevent families from being harmed, and will continue to foster a culture of health and wellness in the District of Columbia. Thank you for your support of the Healthy Hearts of Babies Act of2015; we ask for a favorable report. I am happy to answer any questions.

62 - '. -. '... '.' ,.:.--i~-;3 ' - '.-;' ~ -,. c. ; FAGTS Precious Information, ; -.. "'---._,_ ~ r?tt~i:.:~.-., -.. Amencarf"'- -Amer1can '' ' Helfrt'! -stfol(e' ' ' - ---AssocfatiaW 'Asso e:raiion~ - :~'-" r'_,:_ ~;- --- :,_.. PL1isef_o)dffieffy {:;rf?~hin,g fgr Critical Congenital Heart Disease -, - ;..- ;."\ L OVERVIEW _ Congehital-tleart defects are malfdiniations'of the heart or major blood vesselsthat occur before birth. 1 In many cases, howevei~hospital staffma)nljiicleri_tlfythese ".. - defects a_n9 putw~rdlyj1ealt_by infants maybe adrfiittedto nurseriei(ariq disch'arged fronn hosi)ital~ before sigrnfof disease are detected. ;;==- -,,~ 1"~"'.C "'.~ ; ; -. :-; o ' Congenital heii(laefec!s'occur in 8 out of 1,000 live - births.'~ and-are liie most 'Comfriori 6auseof infanfileath, accountillg for27% of infant deaths that are caused by birth defects. 4 _A quarter of infants ;vhohave congenital - heart aefectswill bedlagnos~dv;ith cqtlcal con9e,riita! heart disease (CCHD), a life threatening cc}nditio-ii'that requires surgery or cath~terjntervention \'/ithin the first year611ile.' failure 10 ct etectccfm ani:f late detection of CCH[) rnayl~ad to ~e29~jm rtlj,dity pt]:l~[jth:' ' ' - Fortunately, an ert1erging body _ofevidences1jggeststhat measuring blood oxygen saturation can Increase the chances for~early'diagnasis"ana detecticin"ofccf-{d. 6 Once detected-, many heart clefectsccanbe surgically repaired. It is estimated that)l5% ofri.iiona\es who undergo surgery for --~ chow11t.:r -acii.a-a-ulilioa.' '.: ' -. -'-. - _--,,_- ~;; -,._. --o-. --~. '-.~-;;.;..- RECOMMENDEDED UNIFORM SCREENING PANELFoR.-NE'WsOR:Ns -~:::: :c. ~ : - -- Newborn. s~'re<i hff1 g is: 'weli:c~staliiis hed _siatectia.s ed p u b Ii c health p\ogranitnat invbl_ve~ testini:fa[in[ants for.. metabolic.;t1cirfod!i.~1:.9el;i?![2,?nd qeyefoi)ffiefit9[.,.. /:. disorde\s. Each year, morethan 98% of iiewbomsare 11 screened across the liriited.states far fhese'aisoiders. 10 _."~::.. ~\' ; ::~ :~~~~t~~ ~-:~; -'~ ~?~~- :;7;;~ -~-~,~~,~~~~~ ~;;~~_-::::;; ;;~ ~~:r;;;-y. ~',}1;. :>;~' ~_,:,.,.~, ~~ -~"... In 2002, the HealthResour.ces and Services Administration (H RS,.I\) ~ :11)d1\iJi~11~.t~.~~de~ii.C20J1~9~.ot~~gLca~:. Genetics to develop a list of conditions that aljstates could con~1c1_e[j'! 1g~l!]~ Li ttfairi?t~~-~i~rf ~[118r'.l,[r!S:1~./r ise~t is call~d lhe Hecomm_endec! un1forrn Screening f'ane113 an'd it ~~;b~~~fi~jj~! ~ ~~~J~~J~ 0 aii~~a r~:~f~j~~19c~;;h~or~ -_ Recommenci'ecj P:1 ~1 Ha.s [e~jg gre9\ei uniformity among states in their adopti6ifofscreenlrigprograrijs:1j.jl)ew -- conditions for screening are frequehtfynom'iiiaieci ioi inclusion in the Panel. - 1ri Sepiem5eho11, the u.s. Secretary of Health and Human Services end_orsed the addition of CCDH screening to the Recommended Un'iform Screening Panel for newborns. 14 Additionally, the Secretary's Committee on Heritable Disorders in Newborns and Children. recommemds fua\ hosp\tajs JJSe a Specific type of test called pulse oximetr)i to s-creen infants for CCHD. 15 CUSTOMARY SCREENING PRACTICE. Several fools are reguiarfyi.rs'ed to idil'ritifyirifants who have-heiirtdefects:-- " ~ :o::.,,..,. - -.,-- Pninat_al ultra~ounili{peil'clrmedfa:20 weeks info a ' -, tfrergn:ancy ~~n-;reye'~r-~ilatdmicaf ~s. n_qr8rr1antiss) 6 - ;.: RiiuUne prenatal ulfrasounds; however; detect less than.. so% of c;cho.' aod'ra_tesaf cietection depend on differing - levels "of access to prenatal ultrasound and degree of: pr86titlc)ner.trainifi9. 5 <;:~_;,~:~:.::.. ~: ~.--.-_-;-,..,_., -<_ : --,: :- - Aiteii birth, ihfants aie physically examined by primary care providers both before hospital discharge and in_ routine fol.low-up Visits. Physical exam results may lead clinicians to perform aaditionaltests; including Cfiesr - radiographs, echocardiogramsi and pulseoximetry. 5 '", ='~.--2--,. ::- ~ :.:-,"!~ -;;;,: -,,::: ~~,-;:,,;;-,~- _.-,.-.. ~.::-:.c-- - ;. ~ Although prenata)ultrasolirids and postnatal physical exams successfully detect many hear! cjefectsand '" _. detection rates have improved since their a-dvent, tliey are not sufficient to diagnose all cas;,s-6(cchd. 5 New -;, research suggests that When all infants are- screened using pulse oxinrietry iii conjunction with' the routine practices, :. CCHD can be detected over in over 90% 'ofnewborns." PUI:SCOXiNf" """'" ;:-:_";.C;:~:;;f;_. - Pulse oximeliyscreening is a lovi;-co.st, noo,ioya~iv,e and _ painlesfbedside diagnostic test that.can be_ coinpfeted by - -. " ' ~ a technician Jn. as little_ as 415 secon_ds.. pulse oxirnetry -, testing is cond uded tq ~stirijate toe percentage of herj]oglobin in the blo.odthaus saturated with oxygen.._ When the screening identifies n ewbbrns with low blood oxygen concentration, additional testing can be completed to detect heart defects or other life.threatening conditions ' that c9_u1d t~ye. fla.ri_~xfu~jiie>cte,d.~<,;_,::,,;, ;~ Many 0 stuiliiis'st'iciwth'al:pulse oxfrri.etry''serel~illgfor; cctio h_as a less thaii9ii~ percent chari2ii'of giving false positive re~sh1ts. 1 ' r=a1seposftivescreenin9resu1fs for c CCHD can stiil offerinfo~niatioil to_(foctors: roughry 25%of infants identified as fiavin9 iciw:!lfod'ci'oxygen without ' CCHD may be diagnosed wiiji- aftier conditions thatrequire medical inte.rv-~nti8~'~ ' ~ ' 0.~ '" _ <c, The American Heart Ass6daHon (AHA), the Arnerican AcacternycJfPeilJa:triC::s (Al\P)::ana ihe American college of Cardiology Founi:!atiori (ACCF) recently ouflined - recommendation's for a standardized pulse oxiinetry screening approach middiagnostic follow-up.'.. Acc;orcling to these r~cornfn'e,nifa~qn$; scre~ningshould be 'perfo-ime_d onasymptomatic newborns after 24 h_ours of life in order to avoid false-positive resl.jlts. 8 - ' _, American Heart Association Advocacy Department 1150 Connecticut Ave. NW Suite 300 Washington, DC Phone: (202) Fax: (202)

63 FACT SHEET: Pulse Ox Screening for CCHDs When pulse oximetry screening identifies newborns with low blood oxygen levels, echocardiography can be used to definitively diagnose heart defects. 5 The AHA/MP/ACCF recom'mendations emphasize that echocardiograms should be interpreted by pediatric cardiologists. 8 Studies have shown that underserved and rural areas can use telemedicine to access pediatric cardiologists for CCHD diagnosis.' 21 ' 22 Pulse oximeters are available in most neonatal units, and hospital staff are well trained in how to perform pulse oximetry screening. 19 A recent cost-effectiveness analysis estimated that universal newborn pulse oximetry screening would cost just under $4 per infant. 23 Although there are monetary costs associated with false positive results from pulse oximetry screening, these costs may be partially or fully offset by early diagnosis of infants with CCHD before they become ill and/or incur irreversible damage. Research suggests that the cost savings associated with early detection of a single case of CCHD could exceed the costs associated with screening 2,000 infants. 17 Many clinicians and experts agree that the benefits of detecting CCHD far outweigh the costs incurred by the screening itself. Although there is not a clear way to bill insurers for pulse oximetry screening at this time, many other routine newborn tests, including hearing screenings, are frequently included in the bundle of services that hospitals provide to infants prior to discharge.' STATE POLICY APPROACHES States across the nation are beginning to work to implement.the Secretary's recommendation to screen all newborns for CCHD. State policies have a substantial effect on newborn,,cree.ojng...rates...resear.ci+..sl+ow.s...that-sgr.eeml-rl -.f'.at.es-af'.e---+-c;:;_.t.,;;r.,:;:.;~,;;,~=ii;~.,~~.~ Significantly higher in States that have passed test-specific legislation than in states without these Jaws.26 While some individual pf"oviders Of hospital systems may initiate VOiuntary pu]s8 OXimetry screening, legislative action is the 2. Reller MD, Strickland MJ, Riehle-Colarusso T, Mahle WT, Correa A. Prevalence of congenital heart defects in metropolitan Atlanta , J Pediafr. 2008;153: Go AS, el al. Heart Disease and Stroke StatisLics update: a report from the American Heart Association. Circulation. Published online December 18, Go AS, Mozaffarian D, Roger VL, et. al. Heart disease and stroke witistics-2013 update: a report from the American Heart Association. Cirrnlalion. 20l3;127:e6-e2455. M.ib.le 'NT, Newburger JW, Matherne GP, et al. Role of Pulse 0.timetry i_n Examining Newborns for Congenital Hean Disease: A Scientific Statement from th.e American Heart Association and American Academy of Pediatrics. Circulation. 2009;120(5): Chang R-KR, Gurvitz M, Rodriguez S. Missed Diagnosis of Cri1ical Congenital Heart Disease. Arch Pedial Ado! i\fed. 2008; I ti2(10): Rieble-Colaruss T, Mahle WT, Correa A. Death due to delayed diagnosis of congenital hear1 disease: 11 coniemporary populaiion-based srudy. Congenit Hearl Dis, 2007;2:376. Abstract. 8. Kemper AR, Mahle WT, Martin GR, et al. Strategies for Implementing Screening for Critical Congenital Heart Disease, Pedialricr. 201 l; l28(5):el259-el Warnes CA, Williams RG, B~shore TM, et al. A CCI AHA 2008 Guidelines for the Management of Adults With Congenital Heart Disease: Executive Summary. Cir cu/ation 2008;118(23): l 0. Centers for Disease Control and Prevention. Using tandem mass spectrometry for metabolic disease screening among newboms. i'vllvlwr. 2001;50(RR03]: Centers for Disease Control and Prevention. lrnpact nf expanded newborn screening United States, JvlMWR. 2008;57(37): Watson MS, Mann MY, Lloyd~Puryear MA, Rinaldo P, Howell RR. Newborn screening: towa:u a uniform screening pand and system. Gene I. i'vfed. 2006;8 Suppl 1: ls Secretary's Advisory Committee on Heritable Disorder-5 in Newborns and Children. Recommended Unifonn Screening Panel. Health Resources aod Services Administration; 2011: Sebelius K. HHS Secr!tary adopts recommendation to add Critical Congenital Hearl Disease to the Recommended Uniform Screen.in!!: Panel Availa~le at: rnmendutionslc orrespondenee/cyanoticheartsecre092 l20j I.pdf. Accessed June 11, Secretary's Advisory Committee oo Heritable Disorders in Newboms and Children. Addition of Critical Congenital Cyanotic Heart Disease to the Commim:e's Recommended Uniform Screening Panel AYRllnble at: b!tp:/iw\vw.hrsa.gov/advisorycommittees/mchbadvisoryiberitabledisorders/recommendationslc orrespondence/criticalcongenital.pdf. Accessed June 12, 20l Allan LD. A practical approach to fetal bear! scaulliog. Semin Perinatal. 2000;24(5): de-wahl Granelli A, Wennergren M, Sandberg K, et al. impact of pulse o;i;:i:neuy screening on!be detection of duct dependent congenital heart disease: a Swedish prospective screening study in newborns. BAl ;338(jan08 2):a3037-a Abu-Harb M, Wyllie], Hey E, Rfohmond S, Wren C. Presentation of obstruclive left heart 01alformatiousininfa11cy.ArchDisChi/d.1994;7l:Fl79-F Hoffmao JlE. It ls Time for Routine Neonatal Screening by Pulse Oximetry. Neonatology. 2011;9911J l Ewer A.. FumstonA, MiddletonL, el al. Pulse oximetry as a screening test for congenital bean defects in newborn infants: a test accuracy study with evaluation ofacceptabilicy and cost-effectiveness. Hea/Jh Technol Assess. 2012;16(2). Available at: httpj/ Accessed JWJe 13, Dan.ford DA. Clinical and basic laboratory assessment of children for possible congenital heart disease. Curr Opin Pediatr. 2010;12(5): ~0~0i,iiff, ~.. ~,r.t.1m~. P~'~"~'"f'fT,~1,~m~o~d;;;,;;,,~,~'~'""'~''P~rn~o~tio~ ~o:fr Pediatric Cardiology in Commll.!lity Hospitals. Pediatrics. 2002;109(l):e3-e Peterson C, Grosse SD, Cassell CH, Oster ME, Olney RS. Abstract 228: A Cos1- effectiveness Analysis Of Universal Pulse O;i;:imetry Scri:e:i.ing To Detect Critical Congerrital Heart Disease Io. U.S. Newborns. Circ Cardiovasc Quo/ 0111comes. 2012;5:A State oflndiana. Prevention and Treatment Programs: framinatirm of Infants for Phenylketonuria. Hypothyroidism, and 01her Disorders.; Available at; only way to ensure equitable and uniform CCHD screening bttp:// Accessed June 14, for alf newborns 25. Colorado Genera.I Assembly. House Joint Resohttion ; Available at THE ASSOCIATION ADVOCATES The AHA is committed to advancing public policies that will allow children and adults with heart defects to live longer and fuller lives. These policies include: State adoption of mandatory CCHD screening using pulse oximetry for all newborns; The collection of screening data to be used for surveillance, evaluation and continuous quality improvement of CCHD screening; 8 The development, dissemination, and validation of screening standards for CCHD; The continued development of FDA's guidance document regarding the safety and effectiveness of pulse oximeters. 30 References 1. American Heart Association. Common Ty-pes of Hean Defects Available at: bttp:// Defects/Common-Types-of-Heart-Defects _UCM_ _Anicle.jsp. Accessed June 12, 20\ 2. bttp:/lwww.statebil!info.com/bil!s/bills/l2/hjr1014_eor.pdf. Accessed Juoe 14, Georgia Gener.ii Assembly. HB Regular Session.; Avallable at: bttp://wv.'w.legis.ga.gov/leglsl11!ion/en-us/display/ /hb/745. Accessed Juoe 15, Minnesota Department of Health. Newborn Screening Parental Options Avnilable at Accessed June 25, Green DR, Gaffney M, Devine 0, Grosse SD. Determining the Effect ofnewborn Hearing Screening Legislation: An Analysis of State Hearing Screening Rates. Public Health Rep 2007;122(2): Scbwamm LH, Audebert HJ, Amarenco P, et al. Recommendations for the Implementation oftelemedicine Within Stroke Systems of Care A Policy Statement From the American Hean Association. on behalf of the American Heart Association Stroke Council; Couoeil on Epidemiology and Preveotion; l.oterdisciplinary Council oo Peripheral Vascular Disease; and the Council on Cardiovascular Radiology aod Intervention, ed. Stroke. 2009;40: US food and Drug Administration. Draji Guidance for industry and FDA Sta.ff: Pidse 0.timeters - Premarkel Notification Submissions [510(k)s]. US food and Drug Administration, Center for Devices nod Radiological Health; 2007: Avai!nble at: ments/ucm07!376.pdf. Accessed June 12, A.'i.A/HPfS/