Failure to Identify/Manage Neonatal Hyperbilirubinemia

Service: Risk Management
Subject: Care
Setting: Obstetrics

Jaundice (hyperbilirubinemia) develops in a large proportion of neonates within the first week of life and is harmless for most. For a small percentage of infants with jaundice, their total serum bilirubin (TSB) can reach potentially dangerous levels (severe hyperbilirubinemia), which left untreated may cause adverse sequelae such as kernicterus or acute bilirubin encephalopathy (a rare preventable form of brain damage). The clinical recognition and diagnosis of severe hyperbilirubinemia can be difficult, particularly if visual inspection alone is used to estimate the bilirubin level of an infant with jaundice. In 2015, neonatal hyperbilirubinemia was recognized as one of Canada’s “never events” (defined as “patient safety incidents that result in serious patient harm or death that are preventable using organizational checks and balances"). (Canadian Patient Safety Institute and Health Quality Ontario, 2015). Never events for hospital care in Canada: Safer care for patients). Never events for hospital care in Canada: Safer care for patients. Subsequently, some provinces (e.g., Ontario) have developed hyperbilirubinemia best practice quality based procedures and measures. 

Common Claim Themes

  • Significant number of claims involve at-risk infants, specifically:
    • Pre-term birth and premature infants;
    • Infants born to pregnant persons with known glucose-6-phosphate dehydrogenase (G6PD) deficiency.

System

  • Inconsistently performed quality reviews following jaundice-related neonatal harm incidents.

Policies/Guidelines

  • Cumbersome, poorly designed and/or outdated (e.g., not reflecting current best practice) newborn and jaundice order sets, medical directives, protocols and phototherapy/exchange therapy graphs.
  • Absence of and inconsistent neonatal jaundice protocols, policies, treatment/intervention graphs, etc. in the post-partum, neonatal intensive care unit (NICU) and Emergency Department (ED) care settings.
  • Incorrect nomogram used for evaluation and screening based on gestational age of the infant.
  • Lack of accountability and role and responsibility confusion for test results,  in particular with results:
    • Pre-printed and pre-ordered by hospital/health region clerical or administrative staff; 
    • Initiated via medical directives by nurses, advance care nurses and nurse practitioners (NPs);
    • Received post-discharge;
    • Available online only.

Knowledge and Judgement Gaps

  • Knowledge gaps (e.g., signs and symptoms, screening versus diagnostic tools) in post-partum, NICU and ED settings (e.g., nurses, advance care, NPs, medical fellows and physicians).
  • Practitioners’ and parents’ reliance on visual inspection to estimate bilirubin levels.
  • Normalizing of, and premature/inappropriate discharge of infants from ED and post-partum units:
    • Despite at-risk status and/or abnormal laboratory test results; 
    • Without consult with pediatrics (where indicated);
    • Without repeat bilirubin testing as per organization’s policy/protocol;
    • Without confirmation of community support/resources and/or follow-up appointment;
    • Without providing parents detailed discharge instructions/training regarding follow-up and signs/symptoms of deterioration.
  • Delayed identification and treatment of ‘rebound’ jaundice, including in the presence of other comorbidities.
  • Failure to evaluate and/or plot bilirubin levels against age and hour specific nomogram, phototherapy graph and/or the exchange transfusion graph resulting in delayed diagnosis and intervention.
  • Laboratory testing ordered in the absence of an order or a medical directive resulting in confusion, delayed communication of the results to the most responsible physician (MRP), and timely interventions.
  • Inconsistent exams and assessments by ED nurses and physicians (e.g., not weighting the infant or inquiring about birth/sibling history, assessment of breastfeeding, etc.).
  • Delays admitting and/or transferring the infant for specialized care (phototherapy and /or exchange transfusion).

Communication and Documentation

  • Failure to escalate care concerns/disagreements with the care plan. 
  • Inconsistent communication of “normal” and critical test results by laboratories.
  • Informal reports and consultations which are later disputed by the MRP or physician consultant.
  • Failure to consult (and document) with pediatric fellows, physician consultants or MRPs where indicated. 
  • Inconsistent documentation practices of the infant’s clinical history and assessments in the ED (e.g., the infant’s birth and current weight).
  • Delayed and late entries for care provided, including entries made hours or days after the critical incident or clinical deterioration.
  • Material assessments and findings not effectively communicated with the MRP or physician consultant, specifically:
    • The infant’s risk factors for hyperbilirubinemia;
    • The infant’s age (weeks gestation);
    • Birth date;
    • Direct antibody test (DAT) status or if unknown;
    • Test results plotted against age and hour specific nomograms or graphs;
    • Previous test results.
  • Poor and inconsistent documentation of actions taken in response to abnormal assessment and/or critical test results, specifically:
    • Notification of MRP of the assessment or test results;
    • MRP orders in response to the report/consult;
    • The time the IV was established;
    • Type and timing of phototherapy;
    • Whether a Bili blanket was applied;
    • Timing of consult with the specialized pediatric facility and inter-facility transport team/emergency medical services (EMS);
    • Arrival of inter-facility transport team or EMS.
  • Cumbersome and poorly drafted medical directives.
  • Lack of debriefing sessions and “lessons learned” 

Equipment/Supplies

  • Inadequate/outdated and malfunctioning equipment (e.g. phototherapy equipment). 
  • Units/programs without Bili blankets.

Case Study 1

A jaundiced infant was admitted to NICU under the care of a NP. Medical directives and management plans were in place specific to the management of neonatal hyperbilirubinemia. A TSB was ordered revealing values of greater than 450 (abnormal).  A conservative management plan was instituted by the NP. The infant continued to deteriorate and was later diagnosed with kernicterus. Expert review of the case was not supportive of the care in the NICU, noting a lack of compliance with the medical directive and related policies that suggested the need for immediate phototherapy and exchange treatment therapy as well as failure to recognize the gravity of the infant’s status as the infant remained in a state of severe hyperbilirubinemia for an extended period of time. Further, there was no documentation to suggest that NP consulted with the pediatrician on call. The infant’s MRP indicated that they were never informed of the infant’s deterioration once the infant was admitted to the NICU.

Case Study 2

An infant’s umbilical cord blood was forwarded to the laboratory for blood group, DAT and Rh status. The results showed positive DAT, these results were communicated to the lab by a ward clerk. TSB was automatically ‘pre-ordered’ online. One of the newborn medical directives required nursing staff to order a TSB for infants with a positive DAT and to communicate the results to the physician/MRP. The results were available online a couple of hours prior to the infant’s discharge. The results were not reviewed until the infant presented to the ED three days later. The infant was diagnosed with severe hyperbilirubinemia. Review of the case indicated that the discharging nurse and MRP were not aware that testing had been ordered as it had been pre-ordered automatically, and the nurses who initiated the medical directive failed to communicate the test results. Peer experts were not supportive of management of the infant, including the hospital’s use of multiple, cumbersome and confusing policies and medical directives to guide the care of newborns.
 

Mitigation Strategies

Note: The Mitigation Strategies are general risk management strategies, not a mandatory checklist.

Reliable Care Processes

Postpartum and neonatal intensive care units

  • Implement a standardized process to ensure all neonates:
    • In hospital during the recommended 24-72 hour window are assessed, screened and/or tested for hyperbilirubinemia prior to discharge;
    • Who are not in hospital (e.g., home birth, early discharge) during the 24-72 hour window have alternate access to assessment/screening/testing outside of the hospital setting.

Postpartum, neonatal intensive care units and emergency departments 

  • Implement strategies to ensure MRPs personally assess – prior to discharge – infants visibly jaundiced and/or at higher risk (e.g. ABO incompatibility, positive Coombs test) with pending Transcutaneous bilirubin (TcB) or TSB test results.
  • Adopt a standardized evidence-based neonatal jaundice policy(ies), protocol(s) and management pathway(s) for inpatient (postpartum and NICU) and ambulatory  ED management.
  • Ensure the neonatal jaundice policy(ies), protocol(s) and pathways address (but not limited to):
    • Actions to be taken whenever jaundice is suspected or observed by staff, or reported by parents and family members (e.g., visual inspection is not sufficient);
    • Actions to be taken whenever TcB or TSB results consistent with increased risk for hyperbilirubinemia are identified;
    • Follow-up plans for infants not assessed, screened and/or tested prior to discharge (e.g., neonates who are born outside of the hospital or who are not inpatients at 24-72 hours of age, parents declining testing, communities without breast feeding or jaundice clinics);
    • Follow-up plans for weekends and holidays and families residing in communities without immediate access to breastfeeding and jaundice clinics.
  • Adopt a standardized current evidence-based:
    • Gestational age hour-specific nomograms for reporting TcB and TSB findings;
    • Phototherapy treatment graphs;
    • Exchange transfusion graphs.

Communication and Documentation

Postpartum, neonatal intensive care units, emergency departments and outpatient breastfeeding and  jaundice clinics

  • Implement a reliable process to ensure jaundice and hyperbilirubinemia polices, guidelines, medical directives, nomograms and phototherapy and exchange transfusion graphs remain current and reflective of the current standard(s) of care.
  • Adopt a standardized internal communication technique (e.g., SBAR or template to communicating neonatal jaundice assessments and test results with physician consultant and/or MRP that includes (but is not limited to):
    • Why report/consult is taking place (e.g., “I’m calling regarding baby Jane Doe’s TSB result and progressively worsening jaundice over the last 8 hours”);
    • Age of the infant in weeks gestation and date and time of birth;
    • Reminder as to last assessment or test results (e.g.,  “The last TSB testing took place at 1435 and was 209”) as plotted on the nomogram;
    • DAT result, including if it is unknown;
    • The infant’s risk status for hyperbilirubinemia;
    • The current test result as plotted and interpreted against the nomogram or phototherapy or exchange transfusion graph; 
    • Clarity as to how the physician consultant or MRP would like to proceed.
  • Adopt a standardized transport call communication template to communicate neonatal jaundice assessment and test results with transport staff that includes (but is not limited to):
    • Last TcB and/or TSB result
    • Risk status for hyperbilirubinemia;
    • Current test result;
    • Timing of current treatment(s).

Medical Directives

Postpartum, neonatal intensive care units, emergency departments and outpatient breastfeeding and jaundice clinics:

  • Adopt best practices for creating and implementing neonatal jaundice medical directives, where utilized (e.g., use of concise instructions and orders on how to provide the care; a preexisting physician or midwife – patient relationship, and appropriate evaluation and supervision of the practitioner accepting the delegation).
  • Ensure annual signoff of applicable neonatal jaundice medical directives by all midwives and physicians whose neonatal patients may receive care pursuant to the medical directive (e.g., annual review and sign-off as part of their re-appointment process).

Critical Test Results

  • Ensure critical bilirubin levels and positive DAT results are included in the organization’s and external laboratory’s (where utilized) list of critical tests and values which require timely and reliable verbal communication with the ordering or most responsible practitioner (use of faxed and online results may not be sufficient).
  • Adopt a standardized and reliable process to manage the receipt and communication of TcB and TSB critical test and values for the inpatient and ambulatory and ED care settings; ensure this process(es) addresses test results initiated pursuant to a system generated ‘pre-order’ or a medical directive as well as critical tests and valued received post-discharge.

Equipment

  • Ensure the organization’s technology replacement program includes (but is not limited to) neonatal phototherapy equipment.  
  • Implement standardized preventive maintenance and quality check program for bilimeteres, biliblankets, phototherapy equipment and TcB machines as per manufacturer’s guidelines.

Patient and Family-centered Care

Postpartum, neonatal intensive care units, emergency departments and outpatient breastfeeding and jaundice clinics:

  • Ensure parents are made aware of hospital/health region protocol for universal assessment, screening and/testing of all neonates between 24-72 hours and/or prior to discharge.
  • Encourage practitioners to use (as well as within handouts for parents) clear and explicit language when discussing the risks of neonatal hyperbilirubinemia, including (but not limited to):
    • The limitations of visual inspection in particular with parents declining assessments, TcB, TSB and/or hospital admission in the presence of persistent or worsening jaundice;
    • The importance and necessity of following-up with the MRP or hospital or community clinic.
  • Ensure jaundice-related instructions (verbal and written) and discussions are individualized to the infant’s gestational age, timing of discharge, jaundice assessments, screening and test results, and the pre-discharge TcB or TSB value (where performed).
  • Implement formal strategies to support and encourage families to escalate quality or safety concerns, including evenings, nights and weekends (e.g., participation in rounds and handovers, family activated rapid response process).

Education

Postpartum, neonatal intensive care units, emergency departments and outpatient breastfeeding and jaundice clinics: 

  • Offer ongoing interprofessional training and education (e.g., problem based learning, in-situ simulations) to support post-partum, NICU and ED team members knowledge of neonatal jaundice and hyperbilirubinemia, evidence based treatment and interventions, nomograms and treatment and transfusion graphs, medical directives and bilimeters (e.g., recalibration requirements, error messages on bilimeters suggesting unreadable and/or extremely high readings, limitations of bilimetres (is a screening, not a diagnostic tool)).

Monitoring and Measuring

  • Ensure a formal systematic interdisciplinary quality of care committee review is undertaken following the harm or death of an infant associated with neonatal hyperbilirubinemia (root cause analysis, assessment of system, team and practitioner contributing factors related to delayed treatment or interfacility transfer, etc.)
  • Implement formal strategies to monitor and measure the complete and timely documentation of neonatal jaundice assessments, screening and testing in all related care settings, including (but not limited to):
    • Histories obtained and assessment performed in the ED, in particular the infant’s birth and current weight as well as breastfeeding/feeding assessment;
    • Jaundice instructions and education provided to parents and substitute decision makers (SDMs), including name of handouts;
    • Concerns from parents regarding neonatal jaundice, lethargy, etc. and the practitioner’s advice, recommendations and health teaching (what was offered and/or recommended);
    • The rationale for not performing routine screening, follow-up testing and/or phototherapy or exchange therapy where clinically indicated (‘early discharge’ and ‘declined’ is not adequate);
    • Scheduled and ad hoc point of care testing (regardless of whether the findings was deemed normal);
    • Action taken in response to the receipt of a positive DAT or urgent and critical TcB and TSB value (e.g., date and time received, date and time MRP notified, order, response to orders and actions taken)
    • Nurses, advance care nurses and NPs’ reports and consults with physicians.
  • Implement formal strategies to monitor and measure the effectiveness and efficiency of, and adherence to neonatal hyperbilirubinemia guidelines, protocols, algorithms and medical directives, including (but not limited to):
    • Adoption of formal process, outcome and balancing indicators (e.g., % of infants receiving bilirubin measurement within the first 72 hours of life; % of hemolytic infants receiving treatment, number of discharges with activated medical directives and/or order set divided by total number of discharges; percent of infants who require phototherapy; number of readmissions within 14 days of life for severe hyperbilirubinemia);
    • Learnings from perinatal near-miss and harm incidents involving neonatal jaundice and hyperbilirubinemia (e.g., chart audits and trigger tools, incident reports, team debriefs, critical incident and quality of care committee reviews, data from provincial birth and perinatal registries, medical legal claims).
       

References

  • HIROC claims files.
  • Alberta Health Services. (2019). Hyperbirubinemia screening, assessment and treatment: Well newborn 35 0/7 weeks gestation and greater. Guideline.
  • Canadian Paediatric Society. (2018). Guidelines for detection, management and prevention of hyperbilirubinemia in term and late preterm newborn infants. Position Statement.
  • Canadian Patient Safety Institute and Health Quality Ontario. (2015). Never events for hospital care in Canada: Safer care for patients. 
  • Champlain Maternal Newborn Regional Program. (2015). Newborn hyperbirubinemia: A self-learning module. 
  • Darling K, Ramsay T, Sprague A, et al. (2014). Universal bilirubin screening and health care utilization. Pediatrics. 134(4):e1017-e1024.
  • Gray C, Adcock L. (2018). Phototherapy devices for neonatal jaundice: Clinical effectiveness, cost effectiveness, and guidelines. Canadian Agency for Drugs and Technologies in Health.
  • Never events for hospital care in Canada: Safer care for patients. 
  • Provincial Council for Maternal and Child Health & Ministry of Health and Long-Term Care. (2017). Clinical pathway handbook for hyperbiluribemia in term and late pre-term infants (>/= 35 weeks).
  • Provincial Council for Maternal and Child Health (2017). Hyperbiluribemia in term and late pre-term infants (>/= 35 weeks) clinical pathway. Toolkit.
  • Romero H, Ringer C, Leu M, et al. (2018). Neonatal jaundice: Improved quality and cost savings after implementation of a standardized pathway. Pediatrics. 141(3):e20161472.
  • SickKids. (2019). Inpatient hyperbilirubinemia management. Clinical Practice Guideline.
  • Winnipeg Regional Health Authority (2018). Jaundice and hyperbilirubinemia in the newborn: Assessment and management. Neonatal Clinical Practice Guideline.
  • Yu T, Nguyen C, Ruiz N, et al. (2019). Prevalence and burden of illness of treated hemolytic neonatal hyperbilrubinemia in a privately insured population in the United States. BMC Pediatrics. 19(53