Failure to Identify / Manage Neonatal Hyperbilirubinemia, Hypoglycemia, and / or Sepsis and Septic Shock

Neonatal hyperbilirubinemia and hypoglycemia are common metabolic issues within the first few days of life. While permanent brain injury in term infants is relatively rare, two causes of such injury are neonatal hyperbilirubinemia and hypoglycemia. 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. Two of the challenges associated with the timely diagnosis and treatment of neonatal hypoglycemia have been the lack of an accepted glucose level which is considered predictive of long-term neurological sequelae, and the presence of confounding non-specific signs and symptoms of hypoglycemia (e.g., irritability, lethargy, inadequate feeding). In 2015, neonatal hyperbilirubinemia and hypoglycemia were recognized as two 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 & Health Quality Ontario, 2015)). From a medical legal perspective, delayed point of care and laboratory testing, infrequent monitoring of at risk and symptomatic infants, and delayed interventions have contributed to multimillion dollar settlements.

Expected Outcomes

Adopt standardized, evidence-based neonatal hyperbilirubinemia, hypoglycemia, sepsis and septic shock, and Group B Streptococcus (GBS) management protocols to ensure a systematic and coordinated approach.

Implement formal strategies to provide ongoing and targeted education and training to care teams and families surrounding neonatal hyperbilirubinemia, hypoglycemia, sepsis and septic shock, and GBS.

Adopt standardized quality indicators for neonatal hyperbilirubinemia, hypoglycemia, sepsis and septic shock, and GBS. 

Definition and Acronyms

• Client – includes all persons who receive healthcare and related services including patients, residents and persons in-care
• ED – emergency department
• GBS – Group B Streptococcus also known as Group B Strep infection
• Medical directive – an indirect order that gives authorization to a care provider or group of care providers (e.g., ED nurses) to implement the order (e.g., ED chest pain for adults) with a predefined client population (e.g., ED patients presenting with symptoms suggestive of cardiac ischemia or cardiovascular symptoms such as discomfort jaw to umbilicus, upper limb discomfort without known injury, chest trauma…)
• MRP – most responsible practitioner, often a midwife, nurse practitioner or physician
• NICU – neonatal intensive care unit
• Situational awareness – deliberate and active scanning and assessing of the situation to maintain a holistic understanding of the environment in which the team is functioning.
• TcB - transcutaneous bilirubin 
• TSB – total serum bilirubin 

Common Claim Themes and Contributing Factor

Organizational

• Lack of a systematic approach to neonatal quality of care reviews related to (but not limited to) neonatal hyperbilirubinemia, hypoglycemia, sepsis and septic shock, and GBS.
• Inadequate, outdated, or confusing neonatal clinical protocols, medical directives, and order sets in birth, postpartum, NICU and ED care settings.
• Clinical protocols not readily available, or only online and cumbersome to access.
• Lack of accountability and role / responsibility confusion for test results, in particular with results:
  • Pre-printed and pre-ordered by clerical or administrative staff;
  • Initiated via medical directives;
  • Received post-discharge;
  • Available online only.

Knowledge and Judgement

 

• Decreased vigilance and incomplete assessments for at risk neonates considered asymptomatic (e.g., asymptomatic neonates at risk for hypoglycemia or hyperbilirubinemia).
• Delays in recommending and requesting hospital attendance and / or arranging NICU admission, in particular for neonates with jaundice.
• Practitioners’ and parents’ reliance on visual inspection to estimate bilirubin levels.
• Inconsistent feeding assessments, in particular during night shifts in ED and postpartum care settings, including relying on parental reports but not observed or assessed feds.
• Failure to or delays notifying the MRP or on-call practitioner of abnormal and borderline screening and diagnostic blood work.
• Delays initiating orders and medical directives for point of care screening, testing, and monitoring resulting in hours to days of pronounced hyperbilirubinemia, hypoglycemia, and sepsis.
• Diagnosis and treatment delays due to the inappropriate reliance in screening tools (e.g., point of care testing) to confirm the diagnosis or severity of neonatal hyperbilirubinemia and neonatal hypoglycemia.
• Failure to evaluate or plot bilirubin levels against age and hour specific nomogram, phototherapy, and exchange transfusion graphs resulting in delayed diagnosis and intervention.
• Lack of awareness or compliance with the program’s or evidence-based neonatal:
  • Hypoglycemia testing and management protocols;
  • Hyperbilirubinemia testing and management protocols;
  • Sepsis and septic shock protocols.
• Inconsistent histories, exams, and assessment by ED staff in the presence of neonatal lethargy, inadequate feeding, or jaundice (e.g., not asking about birth weight or not weighting the infant; not inquiring about birth and sibling history; not assessing breastfeeding).
• Normalizing of and early discharge of neonates from birth and postpartum units, and EDs:
  • In the presence of at risk status and / or abnormal laboratory test results;
  • Without consult with pediatrics (where indicated and available);
  • Without repeat bilirubin testing as per organizational policy / protocol;
  • Without confirmation of community support, resources, and / or follow-up appointment;
  • Without providing parents detailed discharge education and instructions regarding follow-up and signs / symptoms of deterioration;
  • Without timely communication to the community / primary care provider.

Equipment

• Inadequate or outdated and malfunctioning equipment (e.g., phototherapy equipment).
• Units / programs without access to bili blankets.

Communication

• Ineffective communications with parents including, failure to:
  • Acknowledge or consider parental concerns;
  • Offer / provide translation services where indicated;
  • Offer / provide handouts and discharge training in common languages spoken by pregnant and postpartum persons;
  • Communicate with cultural sensitivity.
• Failure to notify social work and / or child and family services where indicated (e.g., parental decision putting the neonate at risk for serious, foreseeable, and imminent harm).
• Lapse in situational awareness, contributing to delayed recognition of and response to insidious and rapid clinical deterioration of the neonate.
• Failure to escalate care disagreements (e.g., escalating unresolved care disagreements with the MRP) in a timely way, or at all.
• Inconsistent or unreliable communication of critical test results by laboratories.
• Tolerance for informal reports and consults (e.g., hallway chats) which are later disputed by the MRP or physician consultant.
• Lack of team briefings, huddles, and debriefings.

Documentation

• Inconsistent documentation of:
  • Nurse-physician, nurse-midwife, nurse-nurse practitioner, midwife-physician, resident-physician ‘reports’ and consultations;
  • Newborn assessments, vitals, and feeding assessments;
  • Reasons for not conducting, recommending, or performing immediate / urgent screening, diagnostic testing, or management protocol;
  • Follow-up plan when discharging infants without reassurance of feeding or in the presence of neonatal jaundice; 
  • Verbal, telephone, text, apps, written information, and / or instructions provided to parents, including details of the advice provided.
• Delayed and late entries for care provided, in particular entries made hours or days after the critical incident or clinical deterioration.
• Inadequate documentation of actions taken in response to abnormal neonatal assessments and critical test results.
• Inconsistent documentation of shared decision making (informed choice - informed consent) discussions surrounding parents:
  • Declines for screening, testing, and / or follow-up at clinic or hospital particularly newborn screening, neonatal hyperbilirubinemia, and / or neonatal hypoglycemia;
  • Requests for early discharge in presence of neonatal risk factors or prior to recommended screening or testing.

Pregnant and Postpartum Persons

• Declined routine and recommended care and monitoring in particular for neonatal hyperbilirubinemia and hypoglycemia.
• Common allegations related to informed declines:
  • Did not remember the conversation or “that” detail;
  • Perception that MRP, consultant, or team endorsed / encouraged the person’s choice to decline the intervention;  
  • Did not understand the impact of their decision on the neonate;
  • Description of risks did not resonate, particularly risks for the fetus or neonate;
  • Use of vague medical language and statistics that minimized the consequences, particularly risks for the fetus or neonate;
  • Confusing, vague, or conflicting handouts and decision aids;
  • Was not informed of hospital policies, professional association clinical practice guidelines, standards, etc. that ‘conflicted’ with their choice.

 

Mitigation Strategies

Care Processes 

• Implement a standardized process to ensure all neonates:
  • In hospital during the 24-72 hours window are assessed, screened, and / or tested for hyperbilirubinemia prior to discharge;
  • Who are not in hospital (e.g., community birth, early discharge) during the 24-72 hours window have alternate access to assessment / screening / testing outside of the hospital setting;
  • Receive ongoing and judicious assessments to identify and respond to sudden increase in TSB levels in the immediate days and weeks after birth.
• Implement formal strategies to improve access to screening, testing, and follow-up in hospital and associated labs for community / primary care providers. 
• Implement strategies to ensure MRPs conduct an assessment (ideally in person), prior to discharge of neonates:
  • Visibly jaundiced and / or at higher risk (e.g., ABO incompatibility, positive Coombs test) with pending TcB or TSB test results;
  • At risk of GBS infection (e.g., incomplete maternal prophylaxis during labour).
• Adopt standardized evidence-based neonatal protocols for the assessment, screening, diagnostic testing, and management of neonates at risk of or presenting signs of:
  • Hypoglycemia (Narvey & Marks, 2019);
  • Hyperbilirubinemia (Association of Ontario Midwives, n.d.) (Hyperbilirubinemia CPG Work Group, 2019) (PCMCH & MHLTC, 2018) (Barrington & Sankaran, 2018);
  • Sepsis and septic shock (Farrell, 2020) (Jefferies, 2017) (Association of Ontario Midwives, 2022a).
• Ensure early onset neonatal GBS protocols clarify the action to be taken for asymptomatic neonates with (Association of Ontario Midwives, 2022a) (Association of Ontario Midwives, 2019a) (Jefferies, 2017) (Ronzoni, et al., 2022):
  • Incomplete, partial, or no delivery of intrapartum antibiotic prophylaxis;
  • Pregnant person fever and / or prolonged rupture of membranes greater than 18 hours.
• Adopt a standardized current evidence-based (Association of Ontario Midwives, n.d.) (Barrington & Sankaran, 2018) (Provincial Council for Maternal and Child Health, 2022):
  • Gestational age hour-specific nomograms for reporting TcB and TSB findings;
  • Phototherapy treatment graphs;
  • Exchange transfusion graphs (where offered).
• Implement team debriefs and supports following all significant neonatal hyperbilirubinemia, hypoglycemia, sepsis and septic shock, and resuscitation incidents.
• Implement formal strategies to facilitate the timely communication of discharge summaries (e.g., ED or NICU admission for neonatal hyperbilirubinemia) from the hospital to community/primary care provider (College of Physicians and Surgeons of Ontario, 2019) (Health Quality Ontario, 2019) (Robelia, Kashiwagi, Jenkins, Newman, & Sorita, 2017).

Patient and Family-Centred Care

• Adopt standardized education, training, and discharge instructions for parents and families (including child welfare case workers) that includes signs, symptoms, and specific instructions for seeking care for suspected (SIGNS for Kids Consortium, 2022):
  • Neonatal hypoglycemia (Canadian Paediatric Society, 2019);
  • Neonatal hyperbilirubinemia (Hyperbilirubinemia CPG Work Group, 2019) (Association of Ontario Midwives, 2019b) (Canadian Paediatric Society, 2022) (PCMCH & MHLTC, 2018);
  • Neonatal sepsis or septic shock (Association of Ontario Midwives, 2022b).
• 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).

Team Training and Education

• Implement formal strategies to support and enhance the teams’ clinical knowledge, skills (technical and non-technical), and practical experience surrounding the prevention, recognition, and response to neonatal clinical deterioration, hyperbilirubinemia, hypoglycemia, and sepsis and septic shock, including (but not limited to), scheduled interprofessional and cross-departmental skill drills and simulations.
• Ensure the team training and education strategies consider or involve:
  • Knowledge, skills, and practical experience required for both hospital and community birth and postpartum locations (Association of Ontario Midwives, 2021);
  • Team and practitioner situational awareness (‘helicopter view’) and human factors;
  • Visual assessment of hyperbilirubinemia in neonates with darker pigments;
  • The limitations of the visual assessment for hyperbilirubinemia (e.g., poor overall accuracy for predicting risk of significant hyperbilirubinemia);
  • The limitations of point of care testing for hyperbilirubinemia and hypoglycemia i.e., a screening tool versus a diagnostic tool;
  • The limitations of a negative universal screening results i.e., does not replace the need for ongoing neonatal assessments for days / weeks after the screening (Barrington & Sankaran, 2018);
  • Program areas or sites with limited practical experience with neonatal hyperbilirubinemia, hypoglycemia, or sepsis and septic shock such as EDs, low volume birth sites, and rural sites;
  • Unregulated care providers (where employed), locums, travel, agency, contracted care providers in additional to regulated health providers.

Equipment, Supplies and Technology

• Ensure the hospital’s / health region’s technology replacement and procurement program includes (but is not limited to) neonatal phototherapy equipment and bili blankets.
• Implement standardized preventive maintenance and quality check program (as per manufacturer’s guidelines) for:
  • Bili metres, bili blankets, phototherapy equipment, and TcB machines;
  • Glucometers.
• If the use of jaundice-related apps (software solution for defined tasks) is permitted for use by the healthcare team, validate that the embedded guidelines and tools (e.g., calculator used for the initiation of phototherapy), meets current Canadian evidence based practice (Harrold, Rose, & Cantin, 2023).

Documentation

• Ensure complete and timely documentation of the shared decision making (informed choice - informed consent) surrounding parental declines for routine and recommended screening, diagnostic testing, and interventions for suspected and at risk neonates, in particular declines related to neonatal hyperbilirubinemia and neonatal hypoglycemia; if an informed consent / decline form is used, ensure it is accompanied by complete and timely documentation in the health record.

Monitoring and Measurement

• Adopt a standardized, interdisciplinary, collaborative and evidence-based protocol for conducting quality of care reviews involving neonatal hyperbilirubinemia, hypoglycemia, and / or sepsis and septic shock resulting in client harm or death (Machen, 2023); incorporate system thinking and human factors concepts into the review process.
• Adopt standardized quality indicators for neonatal (Health Quality Ontario, 2019):
  • Hyperbilirubinemia;
  • Hypoglycemia;
  • Sepsis and septic shock.
• Incorporate learning from local, provincial, and national neonatal safety reviews and data into local protocols as well as staff and client education and training.

References

• Association of Ontario Midwives. (n.d.). Clinical pathway manual for Midwifery hyperbilirubinemia screening and management of phototherapy. 
• Association of Ontario Midwives. (2019a). Clinical practice guideline 13: Management of prelabour rupture of membranes at term.
• Association of Ontario Midwives. (2019b). What is jaundice. 
• Association of Ontario Midwives. (2021). Retrieved from Emergency Skills Workshop Manual. 7th Edition: https://www.ontariomidwives.ca/esw
• Association of Ontario Midwives. (2022a). Clinical practice guideline No. 19: Antepartum, intrapartum and postpartum management of Group B Streptococcus. 
• Association of Ontario Midwives. (2022b). Group B Streptococcus in pregnancy: What do I need to know? 
• Barrington, K. J., & Sankaran, K. (2018). Guidelines for detection, management and prevention of hyperbilirubinemia in term and late preterm newborn infants. Retrieved from Canadian Paediatric Society: https://cps.ca/en/documents/position/hyperbilirubinemia-newborn
• Canadian Paediatric Society. (2019). Checking blood glucose in newborn babies. Retrieved from https://caringforkids.cps.ca/handouts/pregnancy-and-babies/blood_glucose_in_newborn_babies
• Canadian Paediatric Society. (2022). Jaundice in newborns. Retrieved from https://caringforkids.cps.ca/handouts/pregnancy-and-babies/jaundice_in_newborns
• Canadian Patient Safety Institute & Health Quality Ontario. (2015). Never Events for Hospital Care in Canada. 
• College of Physicians and Surgeons of Ontario. (2019). Transitions In care. Retrieved from https://www.cpso.on.ca/Physicians/Policies-Guidance/Policies/Transitions-in-Care
• Farrell, C. A. (2020). Diagnosis and management of sepsis in the paediatric patient. Retrieved from Canadian Paediatric Society: https://cps.ca/en/documents/position/diagnosis-and-management-of-sepsis-in-the-paediatric-patient
• Harrold, J., Rose, D., & Cantin, C. (2023). Clinical Practice Alert: Newborn Hyperbilirubinemia. Champlain Maternal Newborn Regional Program.
• Health Quality Ontario. (2019). Percent discharge summaries sent from hospital to community care provider within 48 hours of discharge. Retrieved from Indicator Library: http://indicatorlibrary.hqontario.ca/Indicator/Summary/Percent-discharge-summaries/EN
• Hyperbilirubinemia CPG Work Group. (2019). Management of Hyperbilirubinemia in the Healthy Term and Late Preterm Neonate . Association of Ontario Midwives.
• Jefferies, A. L. (2017). Management of term infants at increased risk for early onset bacterial sepsis. Retrieved from Canadian Paediatric Society: https://cps.ca/en/documents/position/management-infant-sepsis
• Machen, S. (2023, 5). Thematic reviews of patient safety incidents as a tool for systems thinking: a quality improvement report. BMJ Open Quality, 12(2), e002020.
• Narvey, M., & Marks, S. (2019, 12). The screening and management of newborns at risk for low blood glucose. 
• PCMCH & MHLTC. (2018). Clinical Pathway Handbook for Hyperbilirubinemia in Term and Late Pre-Term Infants (≥35 weeks). 
• Provincial Council for Maternal and Child Health. (2022). Hyperbilirubinemia screening: Clinical pathway handbook. Retrieved from https://www.pcmch.on.ca/hyperbilirubinemia-screening-clinical-pathway-handbook/
• Robelia, P., Kashiwagi, D., Jenkins, S., Newman, J., & Sorita, A. (2017, 11). Information Transfer and the Hospital Discharge Summary: National Primary Care Provider Perspectives of Challenges and Opportunities. 
• Ronzoni, S., Boucoiran, I., Yudin, M., Coolen, J., Pylypjuk, C., Melamed, N., . . . Barrett, J. (2022, 11). Guideline No. 430: Diagnosis and management of preterm prelabour rupture of membranes. 
• SIGNS for Kids Consortium. (2022). SIGNS – Spot Severe Illness in Infants, Children and Adolescents. Centre for Safety Research & Healthcare Excellence Canada.