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HSIB Issues New Recommendations on Detection of Neonatal Jaundice

Reliance on the visual signs of jaundice could put newborn babies, particularly those born prematurely and those with black and brown skin, at risk of serious harm, the healthcare safety watchdog has warned.

The latest report from the Healthcare Safety Investigation Branch (HSIB) charts a national investigation on the assessment of neonatal jaundice, which if left undiagnosed and untreated can lead to significant brain damage.

Approximately 60% of term and 80% of preterm babies develop jaundice, caused by too much bilirubin in their blood, in the first week and it usually resolves within 2 weeks. However, in around 1 in 20 babies bilirubin is high enough to warrant treatment. 

The HSIB report, published today, makes a number of observations and recommendations to improve the detection of neonatal jaundice, including updating national guidance and education on the topic, which NHS maternity hospitals and laboratories have been urged to implement.

NHS Resolution reviewed 20 compensation claims for harm secondary to jaundice in newborn babies over a 10-year period, which estimated that these had cost £150.5 million, with future costs likely to increase. 

Initial Case that Triggered the Investigation

The HSIB investigation explored safety issues associated with the delayed diagnosis of neonatal jaundice and looked into the reliance on visual signs as a means of detection. It also considered the impact of a baby's ethnicity on timely diagnosis.

The investigation was triggered by a case of delayed diagnosis of jaundice in a premature newborn baby (baby Elliana) of Black African ethnicity. Blood samples taken on day 1 and day 2 of life showed that she had high levels of bilirubin, but for several reasons this was not acted upon. There were no visual signs of jaundice observed by staff at this time. On day 5 of life, visual signs of jaundice were observed by staff and a further blood test confirmed bilirubin high enough to cause jaundice, so prompting treatment. The baby made a full recovery and was discharged 3 days later, but the case was a good example of several opportunities that were missed to detect jaundice, the HSIB said.

Key findings of the investigation

  • The assessment of visual signs of jaundice in newborn babies is subjective and more challenging with babies who have black or brown skin
  • Stakeholders have differing opinions about the reliability of visual signs to detect jaundice in newborn babies
  • Some neonatal units have introduced safety measures to mitigate the risk of reliance on visual signs of jaundice
  • National guidance from National Institute for Health and Care Excellence (NICE)  does not recommend routinely measuring bilirubin levels in babies who are not visibly jaundiced
  • National guidance for jaundice in newborn babies maybe more applicable to term babies (those born after 37 weeks of pregnancy) than those born prematurely
  • National guidance does not contain information on how to address the challenges of detecting jaundice in newborn babies with black or brown skin
  • Some universities providing education to NHS students on the detection of jaundice are seeking to ensure that teaching aids and literature represent the diversity of the population
  • Levels of bilirubin can vary according to the gestational age of a baby. Laboratory staff do not calculate the gestational age of a baby and, therefore, whether their bilirubin level is within the expected range
  • Laboratory practice varies in terms of whether they set specific reference ranges for bilirubin in newborn babies, whether they have a defined threshold for communicating results to neonatal units,and whether the telephone alert limit (the level of bilirubin that triggers laboratory staff to report the result to clinical staff by telephone) reflects the thresholds in national guidance
  • Neonatal staff may be unaware that laboratories analyse blood samples to see if they are icteric (indicate jaundice). These staff will not know to look for a comment about this on blood test reports.

Recommendations and Observations

As a result of its findings, the HSIB recommended thatNICE reviews the available evidence and updates its guidance if appropriate, regarding the reliability of visual signs to detect jaundice in newborn babies, particularly in babies with black and brown skin, as well as risk factors for jaundice identified by this investigation, including prematurity.

HSIB also recommended that the Royal College of Pathologists work with stakeholders to understand current practice and make any appropriate recommendations to promote the adoption of an icteric threshold at which a bilirubin test may be cascaded or reported, and to make any appropriate recommendations on neonatal-specific reference ranges for total bilirubin and thresholds for direct communication of these results to clinicians.

HSIB made two safety observations, saying it may be beneficial for regulators of pathology services to consider the findings of the investigation and amend their guidance if necessary; and that it may be beneficial to develop a national standardised early warning system track and trigger observation chart for use in neonatal unit settings.

Changes Recommended

Commenting on the investigation, Russell Evans, HSIB National Investigator, said: "The possible harm a newborn baby could suffer due to delayed treatment for jaundice is a risk that is well-recognised across the country, but it is one that continues to persist. We found that the reliance on visual signs could be a contributing factor to this because they rely on subjective assessment - they may not be easily spotted or obvious, and in some cases do not appear. This becomes even more of a safety issue when looking in babies with black or brown skin, and baby Elliana's case illustrated this.

"As a starting point, national guidance could be updated reflect the challenges seen through our investigation and provide healthcare professionals with more detailed information on how to address these challenges. This would align with some of the changes in practice that has begun to emerge - our survey emphasised that some neonatal units have implemented other measures and are moving away from relying on visual detection. Several of the experts and clinicians we spoke to during our investigation felt that change is needed to help to mitigate the risk of that high levels of bilirubin are present but with no obvious visual signs.

"Overall, our analysis, findings and safety recommendations all reinforce that prematurity and ethnicity have an impact on whether jaundice will be spotted and that changes need to be made to ensure that all babies have access to early treatment that reduces the risk of life-changing harm."

Welcoming the report, Prof Timothy McDonald, laboratory director at Blood Sciences, Royal Devon and Exeter Hospital, who acted as a subject matter advisor for the investigation, said: "We welcome the findings of the HSIB investigation. I am sure all NHS laboratories around the country will be keen to adopt the recommendation to maximise the clinical utility of the information we generate related to neonatal jaundice in our pre-analytical checks. Anything we can do to speed up identifying and treating neonatal jaundice will have a huge impact for these babies and their families."