Newborn Screening: Achieving Timeliness Newborn Screening (NBS) is a public health program that provides early identification and follow-up for treatment of infants affected by certain genetic, metabolic, hormonal, and/or functional conditions. The success of NBS programs has made screening routine for over four million infants born in the United States each year. Screening tests are done using a few drops of blood from a newborn’s heel, usually within 24- 48 hours after birth, or by functional testing such as a hearing test, and pulse oximetry test. Each state or territory operates by law, its own NBS program. Prior to the passage of the original Newborn Screening Saves Lives Act in Congress in 2008, individual programs varied in the number and quality of newborn screening tests. Today, 44 states and the District of Columbia require screening for at least 29 of the 32 treatable core conditions. These 32 core disorders are listed on the Recommended Uniform Screening Panel (RUSP) which is reviewed by the Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children (SACHDNC). Recent additions to RUSP include: severe combined immunodeficiency (SCID), critical congenital heart disease (CCHD), and Pompe disease. Adding Newborn Screenings to the State Panel Currently, conditions are added to the RUSP upon approval by the U.S. Secretary of Health and Human Services, based on evidence review and a recommendation from the SACHDNC. When considered to add condition to the state newborn panel, state programs should ensure that every newborn is screened at birth for conditions/disorders that meet all of the following public health criteria: 1) there is documented medical benefit to the affected infant from early detection, and treatment; 2) there is a reliable screening test for the disorder; and 3) early detection can be made from newborn blood spots, or other specific means. The 32 core conditions on the RUSP meet all three public health criteria for adding new newborn screening conditions. March of Dimes is supportive of state policies that include a provision that would automatically add conditions to the state newborn panel once it is approved for the Recommended Uniform Screening Panel (RUSP) by the U.S. Secretary of Health and Human Services. Issue brief Newborn Screening: Achieving Timeliness What is newborn screening? Each year, more than 12,000 babies with serious but treatable conditions are identified by state newborn screening programs. According to the Centers for Disease Control and Prevention, newborn screening is one of the great public health achievements in the 20th century. In order to identify these serious and potentially fatal conditions, health professionals use newborn screening tests. In most cases, these tests require small samples of a newborn’s blood taken before the baby leaves the hospital or within 1-2 days of birth that are analyzed in state laboratories. The results are reported to the child’s health care provider. Thousands of infants have been rescued from disability and death due to the success of current screening practices.1   What is timeliness in newborn screening? Because newborn screening is largely a state-specific public health activity, hospital protocols and laboratory requirements vary significantly across the country. Newborn screening is a multi-step process that involves individual providers, hospital administrators, state health departments, laboratory staff, and courier services to transport blood spots. In November 2013, the Milwaukee Journal Sentinel series Deadly Delays reported on serious delays in testing and followup among newborn screening programs across the country. Key factors in these delays included laboratories being closed on weekends and holidays, slow transport of samples, and insufficient tracking and followup of hospitals that sent late samples. 2 Since then, state and federal officials and stakeholders have been working to improve programs. In 2015, the U.S. Department of Health and Human Services’ Advisory Committee on Heritable Disorders in Newborns and Children recommended timeliness goals for newborn screening programs and established a benchmark for states to achieve 95% of each goal. Those goals include reporting all newborn screening results no later than 7 days after birth and presumptive positive results for time-critical conditions within 5 days. Initial samples should be collected no later than 48 hours after birth and should be received at the laboratory within one or two days for testing.3 Barriers and Solutions Barriers to timely newborn screening can occur at multiple points in the process. They can include inconsistent hospital protocols, transport of multiple days of blood samples in batches, and insufficient laboratory hours and workforce. 3 To address these barriers, states have implemented a number of changes in newborn screening practices including improving transit times, utilization of courier services and expanded laboratory operating hours. Key Points Newborn screening involves the collection of a blood sample, transport of the sample to a state laboratory, and reporting of the results to the health care provider. Newborn screening protocols are not uniform across the states and as such there are inconsistencies in timely results reporting. Timeliness goals include collecting samples no later than 48 hours and reporting results no later than 7 days after birth. Solutions to timeliness barriers include addressing transit time, courier service and lab hours. States that have expanded lab hours indicate improvement in meeting timeliness goals. t The March of Dimes is a national voluntary health agency whose volunteers and staff work to improve the health of infants and children by preventing birth defects, premature birth and infant mortality. Founded in 1938, the March of Dimes funds programs of research, community services, education and advocacy. For the latest resources and information, visit marchofdimes.org or nacersano.org.

State Examples References Improving transit times In 2014, Arizona turned its newborn screening program into a model other states can follow in just a few short months, earning it the first-ever Newborn Screening Quality Award from the March of Dimes. Through the Transit Time Project, the Arizona Department of Health Services (ADHS) established a policy of full transparency for the length of time it takes Arizona hospitals to send newborn blood samples to the lab for analysis, and set a target of having 95 percent of samples screened within 72 hours. 4 Utilizing a courier service In 2015, the Utah Department of Health’s (UDOH) Newborn Screening Program received the Governor’s Award for Excellence for its efforts in improving timeliness and other operational improvement by partnering with FedEx and the Utah Hospital Association to ensure all blood samples would be received by the lab within three days and at no cost to the hospital. 5 Expanding laboratory hours As of April 2017, 33 newborn screening (NBS) programs reported operating at six or seven days a week (see map),6 greatly increasing the lab’s ability to receive and process specimens in a timely fashion. It has been demonstrated that states with expanded newborn screening lab hours are more likely to achieve the 95% timeliness reporting goal.7 References 1. Centers for Disease Control and Prevention. (2016). Newborn screening portal. Retrieved May 25, 2017, from https://www.cdc.gov/newbornscreening/index.html 2. Gabler, E. Deadly Delays, Milwaukee Journal Sentinel, Published November 16, 2013. 3. US Government Accountability Office. (2016). Newborn screening timelines No. GAO-17-196) 4. Arizona Department of Health Services. http://www.azdhs.gov/preparedness/state-laboratory/newborn-screening/index.php#transit-time-home 5. Utah Department of Health http://udohnews.blogspot.com/2015/05/newborn-screening-program-receives.html?_sm_au_=iVVH0rq8TF4WWntH 6. Summary of NBS Operating Hours Survey Results, April 2017: https://www.newsteps.org/newborn-screening-program-operating-hours 7. Newborn Screening Technical assistance and Evaluation Program (NewSTEPs). (2016). NewSTEPs collaborative improvement and innovation network (CoIIN) for timeliness in newborn screening: Final report