Neonatal hyperbilirubinemia (newborn jaundice) is one of the most common physiological manifestations in newborns1-3: Hyperbilirubinemia presents itself in 60%
of term neonates and in 80% of preterm neonates5-6. It is the primary reason for high readmission rates4 due to its onset 2-3 days after birth, often after a neonate has been discharged from the newborn nursery. Although modest levels of hyperbilirubinemia are usually benign, reflecting the physiological maturation of the neonate’s hepatic system, incorrect or delayed diagnosis could lead to bilirubin-induced neurological dysfunction (BIND). In some cases, it may lead to severe brain damage like cerebral palsy or kernicterus 7-8. The clinical risk factors for BIND include prematurity, rapid rate of bilirubin rise (usually associated with isoimmune hemolysis), birth asphyxia, sepsis, hypoalbuminemia, and temperature instability29. In the current healthcare environment which encourages a decreased hospital stay9, neonates face a greater risk of readmission for a number of reasons. Therefore, diagnostic assays for bilirubin should be adjusted in order to achieve accurate measures of bilirubin, reduce time to appropriate intervention, and prevent the development of chronic hyperbilirubinemia. An easily accessible, low cost, and accurate assay for bilirubin is essential for proper intervention to prevent the development of severe hyperbilirubinemia, especially with an increasing number of babies being discharged early. A system pairing efficient execution with well-defined quality metrics is the rationale for tackling the prevailing high readmissions due neonatal hyperbilirubinemia.
To better understand the need for an easily accessible, low cost, and accurate assay for bilirubin, it is important to first understand the root causes for higher readmission rates. Some of these causes (stemming from misaligned priorities in the current healthcare ethos) that trickle down resulting in inefficient jaundice management are discussed below:
The current US healthcare system faces a chronic misalignment of resources and priorities. The current medicolegal system has placed considerable pressure on practicing neonatologists and pediatricians, collectively leading to defensive testing practices. Physicians employ these conservative practices as lawsuits involving newborns sustaining peripartum neurologic injury can result in an average indemnity payment of $440,379, which may or may not be covered by malpractice insurance. One survey of physicians practicing in “high-risk” fields such as obstetrics found that 93% practice defensively some of the time or frequently.
Healthcare in the United States is not focused on prevention, but on a reactive response to disease. Subsequently, this approach to care (and the associated administrative costs) has contributed to higher newborn mortality rates than most of the industrialized world. For example, of the $2.9 trillion spent on healthcare in 2009, $765 billion was considered “waste”; this included categories defined as unnecessary services ($210 billion), excessive administrative costs ($190 billion), inefficiently delivered services ($130 billion) and fraud ($75 billion)26. Furthermore, physician and ancillary service expenses continued to increase even when median inpatient admissions declined21. Although the US spends more on healthcare than any other nation in the world (18% of gross domestic product)21,27, the
newborn mortality rate in the U.S. was higher than that of Cuba; the overall outcome and life expectancy in the US is ranked much lower than most developed nations10.
The cost of healthcare in the US per capita is the highest in the world. This is a direct consequence of several misaligned priorities, as noted earlier. While much of the cost burden is created by chronic disease management in older demographics, costs related to neonatal care is also significant. The average length of stay for later
preterm newborns is an average of 3.3 days at a cost of $7200, whereas younger preterm neonates have an average stay of 6.3 days at a cost of up to $202,70020.
Overall, costs vary inversely with birth weight and gestational age. To survive in an environment with progressively lower reimbursement rates from both Medicare/Medicaid and private insurers, hospitals have started adopting cost containment strategies, resulting in a shorter than average length of stay for patients.
For neonates, early discharge reduces the ability to effectively screen for hyperbilirubinemia. The burden of screening moves to the outpatient setting, which has
much more variability in patterns of care and available services. These factors ultimately result in higher risk for readmissions due to hyperbilirubinemia. Based
on analysis of obstetrical records (which contained no clinical indication for late preterm delivery) it is suggested that patient and provider convenience are contributing to the increasing rate of late preterm delivery. Late preterm deliveries make up a majority of preterm births and as such, face increased risk of
complications. Potentially avoidable preterm births accounted for 17% of late preterm birth (34-36 weeks of gestation) in one study; another study suggested that unequal (higher) distribution of delivery occurs on Fridays among late preterm neonates. Cost containment strategies implemented by healthcare facilities have been rendered ineffective by these trends, as the cost of care has increased with greater numbers of late preterm newborns admitted to special care nurseries or the NICU (neonatal intensive care unit). Sectors of the healthcare community have now recognized that use of innovative technologies can be used to overcome barriers blocking access to care and improve care efficiency, while simultaneously reducing costs. Developments in healthcare IT and digital health are attempting to tackle avoidable admissions and readmissions, medical errors, defensive practice patterns, clinician and patient communication deficiencies, and bloated administrative services. Point of Care Testing (POCT) is one of several technological advances that have the potential to reduce operational inefficiencies and improve patient monitoring along with diagnostic accuracy. It can empower clinicians to quickly access critical laboratory values at the bedside, meaning time to diagnosis and appropriate treatments are minimized, and complications of delayed diagnosis are reduced. The subsequent downstream cost savings per patient cannot be understated.