This investigation by the Healthcare Safety Investigation Branch (HSIB) explored the detection and diagnosis of jaundice in newborn babies, in particular babies born prematurely (before 37 weeks of pregnancy). Specifically, it explored delayed diagnosis due to there being no obvious visual signs of jaundice apparent to clinical staff.
Jaundice is a condition caused by too much bilirubin in a person’s blood. Bilirubin is a yellow substance produced when red blood cells are broken down. If left undiagnosed and untreated, high bilirubin levels in newborn babies can lead to significant harm. Newborn babies have a higher number of red blood cells in their blood which increases their risk of jaundice. Jaundice can cause yellowing of the skin and whites of the eyes; however, sometimes the visual signs of jaundice are not obvious, particularly for premature or newborn babies with brown or black skin.
The reference event for this investigation was the case of baby Elliana, who was born at 32 weeks and 1 day via a forceps delivery and then transferred to the Trust’s special care baby unit (SCBU). Elliana was assessed on admission to the SCBU by staff as a clinically stable premature baby and a routine blood sample was taken from around two hours after her birth to establish a baseline. Analysis of the blood sample indicated bilirubin was present and so the level was measured. This result was uploaded onto the Trust’s computer system alongside the results of the blood tests that had been requested by the clinical team.
The bilirubin result was seen by a SCBU member of staff who recognised that the level was high, indicating the possible need for treatment. However, this member of staff was then required to attend an emergency and the bilirubin result was not acted upon.
Another blood sample was taken when Elliana was two days old and was uploaded to the Trust’s computer system. It is unclear if this bilirubin result was seen by staff; it was not documented in clinical records and was not acted upon. Over the next two days, Elliana continued to show no visible signs of jaundice that were detected by staff and she was documented to be developing well.
When Elliana was five days old, a change in her skin colour was observed and visible signs of jaundice were detected. A further blood sample was taken which showed she had a high level of bilirubin in her blood and treatment was started accordingly. Elliana’s bilirubin levels returned to within acceptable levels over the next three days and she was subsequently discharged home.
- 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 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 (how long the baby was in the womb). 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.
HSIB recommends that the National Institute for Health and Care Excellence 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
- risk factors for jaundice identified by this investigation, including prematurity.
HSIB recommends that the Royal College of Pathologists works 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.
HSIB recommends that the Royal College of Pathologists works with stakeholders to understand current practice and make any appropriate recommendations on neonatal specific reference ranges for total bilirubin and thresholds for direct communication of these results to clinicians.
HSIB makes the following safety observations:
- It may be beneficial for regulators of pathology services to consider the findings of the investigation and amend their guidance if necessary.
- It may be beneficial to develop a national standardised Early Warning System track and trigger observation chart for use in neonatal unit settings.
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