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Abstract
Objective Over 20 000 US neonates annually make the potentially risky transition from the neonatal intensive care unit (NICU) to the care of primary care physicians whom they have never met. The authors describe the use of Health Care Failure Modes and Effects Analysis (HFMEA) to proactively assess the risks of this transition, and present a qualitative evaluation of the HFMEA process.
Methods The HFMEA team, led by a patient safety specialist, included neonatologists, general paediatricians, nurses, a social worker and a parent of a premature infant. The authors conducted a facilitated debriefing session with the team, interviews of key informants, and a content analysis of documentation generated throughout the project.
Results The authors identified 40 high-risk failure modes and 75 associated high-risk causes. Clear thematic categories included poor communication among care providers in the hospital, between care providers and parents/care givers, or between the hospital-based and ambulatory care providers, as well as a lack of knowledge and skills among community-based providers to care for fragile infants. Evaluation of the HFMEA process revealed a high level of involvement, with over 250 h of professional time devoted to the process, agreement that the interaction itself was valuable and concerns about the limitations of the HFMEA method in capturing the complexity of the transition from NICU to ambulatory care.
Conclusion While HFMEA holds promise for improving the safety of care transitions, the full effort required to realise the potential benefit requires additional evaluation to confirm its value over less intensive means of achieving safer care transitions.
- Adverse events
- NICU
- patient safety
- quality improvement
- risk assessment
- HFMEA
- healthcare quality improvement
- human factors
- quality of care
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- Adverse events
- NICU
- patient safety
- quality improvement
- risk assessment
- HFMEA
- healthcare quality improvement
- human factors
- quality of care
Introduction
The patient safety literature increasingly acknowledges the potential risks of the transitions that patients make between healthcare providers and settings as their care needs evolve.1 2 Infants born prematurely or with complex congenital abnormalities are surviving to discharge in growing numbers. Over 20 000 neonates make the risky transition from the neonatal intensive care unit (NICU) to home each year in the USA, often to the care of primary care physicians (PCPs) they have never met.3 Efforts to minimise lengths of stay in the NICU contribute to increased complexity of healthcare needs at the time of discharge.4 To ensure safe and effective monitoring and coordination of care for fragile neonates, an efficient ‘handoff’ from the intensive care specialist to the ambulatory care provider is critical. Despite their potential significance, little is known about the specific vulnerabilities that involve care transitions from the NICU to home.
Studies from the adult literature reveal significant vulnerabilities around the point of discharge from the hospital. About half (49%) of hospitalised adults experience at least one medical error following hospital discharge,5 and approximately one-fifth (19–23%) of discharged patients experience an adverse event.6–8 Most errors and adverse events in this transition involve communication breakdowns in handoffs between inpatient care teams, patients (or their care givers) and/or PCPs.7 However, few published studies describe the risks of care transitions in care in the paediatric population. Previous studies have measured attendance at follow-up appointments using a conceptual approach that implies that the root of the problem is lack of compliance on the part of care givers, rather than systematic difficulties that lead to delayed or inadequate follow-up. One study found that 28% of children discharged from paediatric (not neonatal) intensive care did not receive timely medical follow-up.9 Most published research on this transition in paediatric patients focuses on the effect of insurance on follow-up or describes early discharge programmes. To prevent potential errors and harm in these care transitions, a thorough understanding of the risks of the discharge process of high-risk neonates is needed. Like many patient safety issues that deal with provider and patient interactions, adverse events related to care transitions can be viewed from a human factors perspective in that poorly designed systems permit less than ideal interactions to occur between the people in the care environment as it shifts from one venue to another.
Proactive evaluation of error-prone healthcare processes may inform interventions to prevent adverse patient outcomes. Health Care Failure Mode and Effect Analysis (HFMEA) is one such approach to improving patient safety. HFMEA is a systematic, team-based method of identifying potential errors and risks within healthcare processes and prioritising targets for intervention or redesign. The method is well described by DeRosier et al and has been successfully implemented in the Veterans Affairs health system.10 To our knowledge, HFMEA has been used in only two published paediatric studies, neither of which involved neonates.11 12 Furthermore, HFMEA has not been used in any setting to study care transitions during the discharge process. We applied HFMEA to identify risks in care transitions involving the discharge of newborns with complex conditions. We also assessed the team's perceptions of advantages and challenges of using HFMEA in the high-risk neonatal setting.
Methods
We conducted the HFMEA at Texas Children's Hospital (TCH), a freestanding paediatric hospital currently licenced for 639 beds, including a 76-bed Level III NICU and a 62-bed Level II nursery. The 10-member HFMEA team was led by a hospital-based patient safety specialist and included neonatologists, general paediatricians, nurses, discharge planners, a social worker and a parent of a premature infant. The team met from October 2007 to April 2008. The institutional review board of Baylor College of Medicine approved the study.
Application of the HFMEA methodology
Using the HFMEA methodology outlined by DeRosier et al., the team initially developed a flow diagram that identified the main processes and subprocesses involved in the discharge of a high-risk infant.10 Once members agreed that all pertinent steps were listed, the team brainstormed for all potential errors that might occur (failure modes) at each step of the process. Each failure mode was then scored on two parameters: the probability that it could occur (frequency score) and the severity of the potential outcome if it did occur (severity score). Frequency and severity were rated on a numerical scale and decided by group consensus. For each identified failure mode, the product of the frequency and severity scores was computed to generate a hazard score. Potentially ‘high-risk’ failure modes were defined as those with hazard scores of at least 50% of the maximum possible score.
The HFMEA Decision Tree tool was used to identify opportunities for intervention.13 Each low-scoring failure mode was evaluated to determine whether it was a single-point weakness, that is, a step in the process that is so critical that its failure would result in system failure or an immediate adverse event. Single point weaknesses were reclassified as ‘high risk.’ Next, we eliminated vulnerabilities for which effective control mechanisms were already in place and failure modes that were so obvious that no mitigation plan would be needed. The team then listed potential contributory factors (‘causes’) for each of the remaining high-risk failure modes and scored these factors using an approach similar to that of the failure modes. The resulting final list of high-risk failure modes and causes was used to guide the development of a comprehensive mitigation plan.
Qualitative assessment of HFMEA
Because the HFMEA methodology had not been used previously to study the neonatal discharge process, qualitative data (described below) were collected from participants at the end of the project to learn about their experiences. A list of challenges that were encountered by the team and their possible solutions was generated by synthesising data from the following three sources:
A facilitated debriefing session was held with the entire team to assess team members' perceptions of the components of the HFMEA method and the application of HFMEA to care transitions within the NICU population. Team members' opinions were solicited about what went well during the HFMEA project and what did not, their perceptions of the value of HFMEA after its evolution over time and suggestions for improving the process.
Key informants (principal investigator, patient safety specialist, social worker, general paediatrician, neonatologist and a parent) were then interviewed to expand upon issues identified in the team debriefing. Additional issues were explored related to the time commitment required from team members, the comfort level of team members with their skills in this area, the resources needed and technical aspects of the HFMEA method.
A content analysis of all documentation maintained by the patient safety specialist, including meeting agendas and detailed minutes, was conducted to enrich findings from the debriefing and the interviews.14
In keeping with qualitative methodology, data collection and analysis were overlapping processes.15 Transcribed notes were analysed to identify and organise content themes that emerged from an inductive reading and rereading of the notes from all three data sources by one investigator (AG). These themes were compiled into a list that was iteratively revised as patterns within the data became more apparent and consensus among the investigators was achieved.
Results
Application of HFMEA
The team held twenty 1.5 h meetings from 1 October 2007 to 30 April 2008. The team began by developing a high-level flow diagram of the entire discharge process, which the team defined as starting with identifying the patient for discharge and ending when a follow-up appointment takes place. The team broke down each of the high-level steps into multiple individual substeps. Figure 1 shows the resulting diagram of the discharge process from the NICU to a primary care paediatrician.
High-level process map with substeps.
The team identified 114 potential failure modes in the discharge process as mapped in the flow diagram. To score failure modes and causes, we initially used the definitions published by DeRosier et al.10 However, the team found the original HFMEA scoring system unsuitable to grade events in the NICU care transition. Members found the subjective descriptions anchoring each severity score to be not relevant to the neonatal population, and rewrote the descriptions using language that better reflected their experience in the NICU. Similarly, the team found the frequency scores at the more frequent end of the scale to inadequately distinguish among frequency differences that were felt to be important in this population. For example, the lowest frequency score in the original scoring system is ‘Frequent… may happen several times in 1 year’; the team agreed that many of the events described in the flow diagram were likely to occur as often as daily. The team added three additional frequency categories to distinguish among these very frequent events.
The revised, NICU-specific definitions (see tables 1, 2) were felt by the team to improve the clarity of severity ratings and specificity of probability ratings such that the process of scoring generated less discussion and moved much more quickly after adoption of the revised system.
Revised severity categories
Revised probability categories
Because the hazard scores are simply the product of the severity and probability scores, the team recognised that simultaneously scoring the severity and the probability of an event might result in team members adjusting some of the scores to make sure that a certain failure mode or cause would be included in the final model. To explore that possibility, the team rescored one step of the process independently. Figure 2 shows an example of a comparison of the scores obtained when one substep scored for severity and probability simultaneously versus those obtained when the same substep was scored independently at a later meeting. The team rescored Step 1 of the process and found that although most of the Hazard Scores changed somewhat, few changed enough to reclassify the failure mode from low risk to high risk or vice versa. For consistency, the team decided to use the original scoring to develop the final model.
Care giver identified and notified about potential discharge.
The final model included 40 high-risk failure modes and 75 high-risk causes. Although some, such as insurance-related causes, were eliminated as events not under clinician or hospital control, the following issues were present across most of the identified failure modes and causes:
Healthcare providers (attending physicians, consulting physicians and other healthcare providers) in the NICU tend to act in isolation, which results in lack of a standardised, coordinated and comprehensive plan of care.
Parents/care givers may be inadequately prepared for home care and management of fragile neonates due to a lack of consistent and early communication between parents and NICU staff and lack of coordinated educational and social services support programmes prior to discharge.
Community providers (including PCPs, home health nurses, pharmacists, and community emergency rooms) may lack the required knowledge and skills to manage complex infants, leading to suboptimal office-based care and perceived overutilisation of the emergency system.
Once these care transitions issues were identified, the team developed a comprehensive plan for corrective action. The plan addresses coordination of information sharing between and among care providers within the NICU, improving parent/care giver preparation to assume responsibility for the child's care upon discharge, and enhancing skill and knowledge of PCPs who receive these infants into their practices after discharge from the NICU.
Process evaluation
Analysis of qualitative data revealed several consistent themes. Overall, the team members thought that the group functioned extremely well, with a high level of involvement from most members and many new insights gained in the process. All team members agreed that the transition from the NICU to ambulatory care was an important and often risky process that warranted proactive risk assessment. Further, there was broad agreement that the time spent during the group activity of defining all of the various steps in the discharge process led to novel discussions in which knowledge about discharges and care transitions emerged in a new way, and information was shared for the first time among the various participants in the discharge process.
Concerns about the HFMEA process included the substantial time commitment required to adequately apply the HFMEA method and the relevance of the original HFMEA scoring system to the NICU setting, discussed previously. Moreover, team members uniformly felt that the HFMEA method was limited in capturing the high degree of clinical complexity inherent in the transition from the NICU to a primary care paediatrician.
The total time commitment from all team members for the HFMEA was substantial. The median number of meetings attended by each member was 16, and no member attended fewer than half of the meetings, for a total of approximately 230 h of professional time spent in the HFMEA meetings. The patient safety specialist and the principal investigator together spent an additional 40–50 professional hours outside the group sessions in preparation for meetings. We estimated the value of the professional hours involved in the HFMEA meetings at approximately $20 000.
Discussion
We used the HFMEA technique to conduct a proactive risk assessment of the complex process of discharge to ambulatory follow-up for high-risk neonates, and identified a large number of high-risk failure modes and associated causes. Many of these related to lack of communication among care providers in the hospital, between care providers and parents/care givers, or between hospital-based and ambulatory care providers. A second common theme was a lack of knowledge and skills among community-based care providers responsible for the care of fragile infants after discharge. To our knowledge, this report is among the first to focus on a systematic risk assessment in the inpatient-to-outpatient transition for fragile infants.
Our findings are of potentially great significance to the increasing number of infants who survive the neonatal period and are discharged to the community with ongoing complex healthcare needs. Survival of extremely low-birth-weight infants (birth weight <1000 g) increased by 35% between the 1980s and the 1990s, with a concomitant rise in disabilities such as chronic lung disease and neurodevelopmental impairment.3 In one large study, the incidence of chronic lung disease (defined as receiving supplemental oxygen at 36 weeks' postmenstrual age) was 23%, severe intracranial haemorrhage 11% and proven necrotising enterocolitis 7%. Poor postnatal growth was seen in almost 100% of infants born at <1000 g.16 Each of these outcomes presents challenges in long-term management of babies following NICU discharge. Given the increasingly complex healthcare needs that community paediatricians must address, it is critical to understand and improve the transition from NICU to ambulatory care.
Potential risks associated with the transition of patients from hospital to ambulatory follow-up are increasingly recognised.5 17 Unlike the usual inpatient ‘handoff,’ the time period between discharge and ambulatory follow-up is prolonged, and lines of responsibility for the patient in the interim are unclear. Despite the increasing availability of electronic health records, follow-up providers may not have complete or accurate information about the patient's condition. Although most studies of adverse events around discharge are from the adult literature, many of these are potentially relevant to the NICU setting. Forster et al, using a telephone interview, found that 19% of adult patients had identifiable adverse events in the 3 weeks following discharge from a general medicine service, with adverse drug events being most common. Similar results were found in a study of patients discharged from Canadian hospitals.6 Beers et al found that 73% of older patients failed to use at least one medication as it was ordered at the time of hospital discharge.18 Coleman found a lower but still alarming rate of medication discrepancies.19 In a review of written discharge summaries, McMillan found an average of more than one medication error per discharge summary.20 Neonates are discharged with many high-risk medications, and thus a similar potential for adverse events exists. In addition, medical conditions often are not completely resolved, and patients or care givers may be unprepared for significant medical care responsibilities at home. When the primary care follow-up visit occurs, it is likely that the provider who sees the infant is not the same provider who cared for the infant during the hospitalisation. Hence, the transition period between the inpatient and outpatient settings has many vulnerabilities to errors that may result in severe consequences.
The HFMEA method has been used in a variety of healthcare settings and has been applied in paediatrics to medication-related processes.21 22 The application of the HFMEA method to care transitions in the NICU discharge process was viewed as potentially valuable but arduous in terms of time and effort. Although the team was sceptical of the overall value of the HFMEA method for studying these care transitions, the team uniformly found value in the opportunity to discuss the discharge process among the disparate groups involved in the process.
Our study had several limitations. We studied the NICU discharge process only at a single institution and adapted the scoring matrix from adult literature. The specific findings of our HFMEA may not be generalisable to other institutions; however, our findings regarding the HFMEA process itself should be widely applicable. As is always the case in a group process, judgements of one or two team members can bias the scoring. We took steps to minimise this through careful discussion with frequent clarification of each team member's input. Although we found the HFMEA method useful, leadership involvement and commitment are essential to enable participants to devote the required time.
In summary, the HFMEA process enabled us to improve our understanding of the critical error points that introduce risk during the transition from NICU to the ambulatory environment. We identified risks related to lack of communication between care providers in the hospital, between care providers and parents/care givers, and between hospital-based and ambulatory care providers. Additional identified risks included potential lack of knowledge and skills among community-based care providers who are responsible for caring for vulnerable infants after discharge. While the HFMEA holds promise for improving patient safety during care transitions, the value of applying this tool to the complex transitions from the NICU to community settings requires additional study.
Acknowledgments
We would like to acknowledge the members of the HFMEA team and S Mathew for assistance with project coordination.
References
Footnotes
Funding This work was supported by a P-20 grant from AHRQ (P20 HS017122-01 ‘Crossing An Invisible Quality Chasm: From NICU To Ambulatory Care’) and in part by the Houston VA HSR&D Center of Excellence (HFP90-020).
Competing interests None.
Ethics approval Ethics approval was provided by the Baylor College of Medicine.
Provenance and peer review Not commissioned; externally peer reviewed.
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