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Efficacy of a Universal Transcutaneous Bilirubin Screening Program



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July 2013

Jaundice is a very common condition in newborn infants that is most often benign. However, acute and chronic bilirubin encephalopathy (acute or chronic neurologic damage resulting from high serum bilirubin levels) does still occur. The American Academy of Pediatrics (AAP) 2004 recommendations regarding newborn jaundice have suggested a more comprehensive screening of newborns for jaundice and its complications.1 These recommendations suggest closer outpatient follow-up to ensure a safe transition into infancy. The Joint Commission has issued a sentinel event alert regarding kernicterus (chronic bilirubin encephalopathy) and the National Quality Forum has deemed it a “never event,” that is,  a serious and costly error in the provision of health care services that should never happen.2,3 Given the rarity of kernicterus, there is much debate about the optimal method of screening for this condition.

The 2004 practice guidelines from AAP recommend that all infants undergo systematic screening for the risk of dangerously high serum bilirubin levels (hyperbilirubinemia) after discharge from the nursery. The guidelines call for either risk factor assessment for each infant prior to discharge or measurement of either total serum bilirubin (TSB) or transcutaneous bilirubin (TcB).1 In 2007, the Canadian Paediatric Society recommended that all infants be screened for risk of hyperbilirubinemia by either TSB or TcB before discharge.4 Similarly, in a 2009 commentary several pediatric leaders suggested that TSB or TcB measurement was necessary in all infants before nursery discharge to screen for the risk of hyperbilirubinemia.5

Although recommendations for bilirubin screening have been made by national groups and experts, the United States Preventive Services Task Force recently concluded that the evidence is insufficient to assess the balance of benefits and harms of screening for hyperbilirubinemia to prevent kernicterus.6 Those who oppose universal bilirubin screening for newborns argue that it may lead to more blood draws for laboratory assessment of serum bilirubin, may lead to more infants receiving phototherapy treatment to reduce serum bilirubin levels, and increase the overall cost of newborn care-pushing the balance for screening towards net harm. In fact, 3 large studies showed that while universal screening for neonatal hyperbilirubinemia decreased the number of infants with very high (>20 mg/dL) bilirubin levels, these programs resulted in either increased usage of phototherapy treatment and/or increased numbers of serum bilirubin laboratory samples.7-9

Several years ago the Department of Laboratory Medicine and Pathology and Division of Community Pediatric and Adolescent Medicine at Mayo Clinic in Rochester began a collaboration to determine how to best use and interpret TcB values from healthy newborns. By studying the observed relationship between TSB and TcB values, a unique screening algorithm was developed based upon the observed bias between TSB and TcB in Mayo Clinic practice.10 Using this algorithm, since February 2010 all infants born at Rochester Methodist Hospital, one of Mayo Clinic’s hospitals in Rochester, Minnesota, have been screened with TcB. Unlike other screening protocols which have combined serum and transcutaneous values for screening and were shown to increase either laboratory serum bilirubin orders and/or phototherapy; Mayo Clinic’s protocol relies entirely on TcB screening. The protocol also accounts for the observed bias between serum and transcutaneous bilirubin in interpretation of values and allows for interpretation of TcB values by postnatal age in hours of life as recommended in AAP guidelines.

A recent Mayo Clinic report describes study of rates of serum bilirubin orders and phototherapy usage for the 1-year period before and after implementation of the universal transcutaneous bilirubin screening program.11 Primary outcomes measured were rates of serum bilirubin orders and phototherapy (per 1000 nursery admissions), and the distribution of serum bilirubin values among infants in the nursery before and after implementation of universal TcB screening.11 The rate of blood draws before (717 per 1000) and after (713 per 100) universal TcB screening did not change in a meaningful way. However, the rate of phototherapy usage decreased from 59 per 1000 before screening to 39 per 1000 after (p<0.0001). The distribution of serum bilirubin values among infants in the nursery is shown in the figure.

Histogram of serum bilirubin values before and after universal transcutaneous bilirubin screening

The average serum bilirubin level for infants in the nursery decreased from 10.2 mg/dL to 9.3 mg/dL after implementation of universal TcB screening (p<0.0001).  As shown in the figure, this was due to a marked  reduction in the number of infants with TSB values  >13 mg/dL after universal screening, and an increase  in the number of infants with TSB <8 mg/dL. In addition, the percent of infants who had very high (>20 mg/dL) serum bilirubin at follow-up outpatient visits decreased from 3% before universal TcB screening to 1% after. Universal transcutaneous bilirubin screening of healthy infants was implemented, resulting in a decrease in both average bilirubin levels and in the percent of infants with very high bilirubin levels, without increasing either the  rate of blood draws for serum bilirubin or use of phototherapy treatments.

Authored by Karon BS, Cook WJ

References:

  1. American Academy of Pediatrics Subcommittee on Hyperbilirubinemia. Management of hyperbilirubinemia in the newborn infant 35 or more weeks of gestation. Pediatrics 2004 Jul;114(1):297-316
  2. Kernicterus threatens healthy newborns. Sentinel Event Alert 2001 Apr;(18):1-4
  3. National Quality Forum. Serious reportable events in healthcare: a consensus report. 2002
  4. Guidelines for detection, management and prevention of hyperbilirubinemia in term and late preterm newborn infants (35 or more weeks’ gestation) - Summary. Paediatr Child Health 2007 May;12(5):401-418
  5. Maisels MJ, Bhutani VK, Bogen D, et al: Hyperbilirubinemia in the newborn infant > or =35 weeks’ gestation: an update with clarifications. Pediatrics 2009 Oct;124(4):1193-1198
  6. US Preventive Services Task Force. Screening of infants for hyperbilirubinemia to prevent chronic bilirubin encephalopathy: US Preventive Services Task Force recommendation statement. Pediatrics 2009 Oct;124(4):1172-1177
  7. Kuzniewicz MW, Escobar GJ, Newman TB: Impact of universal bilirubin screening on severe hyperbilirubinemia and phototherapy use. Pediatrics 2009 Oct;124(4):1031-1039
  8. Eggert LD, Wiedmeier SE, Wilson J, Christensen RD: The effect of instituting a prehospital-discharge newborn bilirubin screening program in an 18-hospital health system. Pediatrics 2006 May;117(5):e855-862
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  10. Mah MP, Clark SL, Akhigbe E, et al: Reduction of severe hyperbilirubinemia after institution of predischarge bilirubin screening. Pediatrics 2010 May;125(5):e1143-1148
  11. Karon BS, Teske A, Santrach PJ, Cook WJ: Evaluation of the BiliChek noninvasive bilirubin analyzer for prediction of serum bilirubin and risk of hyperbilirubinemia. Am J Clin Pathol 2008 Dec;130(6):976-982
  12. Wickremasinghe AC, Karon BS, Saenger AK, Cook WJ: Effect of universal neonatal transcutaneous bilirubin screening on blood draws for bilirubin analysis and phototherapy usage. J Perinatol 2012;32:851-855


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