Health Care Failure Mode and Effect Analysis to Reduce NICU Line–Associated Bloodstream Infections
OBJECTIVE: Central line–associated bloodstream infections (CLABSIs) in NICU result in increased mortality, morbidity, and length of stay. Our NICU experienced an increase in the number of CLABSIs over a 2-year period. We sought to reduce risks for CLABSIs using health care failure mode and effect analysis (HFMEA) by analyzing central line insertion, maintenance, and removal practices.
METHODS: A multidisciplinary team was assembled that included clinicians from nursing, neonatology, surgery, infection prevention, pharmacy, and quality management. Between March and October 2011, the team completed the HFMEA process and implemented action plans that included reeducation, practice changes, auditing, and outcome measures.
RESULTS: The HFMEA identified 5 common failure modes that contribute to the development of CLABSIs. These included contamination, suboptimal environment of care, improper documentation and evaluation of central venous catheter dressing integrity, issues with equipment and suppliers, and lack of knowledge. Since implementing the appropriate action plans, the NICU has experienced a significant decrease in CLABSIs from 2.6 to 0.8 CLABSIs per 1000 line days.
CONCLUSIONS: The process of HFMEA helped reduce the CLABSI rate and reinforce the culture of continuous quality improvement and safety in the NICU.
- CLABSI —
- central line–associated blood stream infections
- CVC —
- central venous catheter
- HFMEA —
- health care failure mode and effect analysis
- IPN —
- infection prevention nurse
- NHSN —
- National Healthcare Safety Network
- QI —
- quality improvement
- RCA —
- root cause analysis
- TPN —
- total parenteral nutrition
Nosocomial infections are a significant cause of morbidity and mortality in the NICU. Prolonged hospitalization, immature immune defenses, and invasive procedures such as central venous catheter (CVC) placement render NICU patients vulnerable to infections.1,2 Overall, an estimated 80 000 CLABSIs occur in the United States every year3 that extend patient length of stay by an average of 7 days, resulting in an additional $3700 to $29 000 in health care costs per infection and yield mortality rates estimated between 4% to 20%.4–7 CLABSIs, once believed to be a consequence of intensive care/hospital stay, are now widely recognized as preventable.5,8 In 2006, the NICU Infection Prevention Committee of our institution pursued several initiatives to reduce CLABSIs. These included developing or revising practice guidelines, reeducating staff on standard CVC line setup, reinforcement of infection prevention techniques, identifying a core group of peripherally inserted central catheter experts for line placement and performing dressing changes, implementation of the surveillance “huddle,” and the use of “care bundles” (Table 1). As a result of these initiatives, the NICU observed a period of 322 consecutive days without a CLABSI in 2009. Over the course of 2010, however, the NICU experienced an increase in CLABSIs. The reasons for this increase were not well understood, although lack of standardized methods to educate staff about new products and inconsistent audits of percutaneously inserted central catheter insertion and maintenance bundles may have been contributing factors.
The heath failure mode and effect analysis (HFMEA) is a systematic team-based approach of prospectively examining a high-risk process and identifying vulnerabilities to proactively implement risk reduction strategies to help mitigate errors.9 It was created by the Veteran’s Administration National Center for Patient Safety for health care. This tool has been widely used in the health care environment to help identify potential failure points in a process that could impact clinical outcomes. HFMEA can be performed before or after implementing a new process because it enables users to focus on process redesign to help prevent errors. It is different from a root cause analysis (RCA) that analyzes how the error took place after the event has occurred. The HFMEA uses a decision tree algorithm that simplifies the hazard analysis steps of the traditional failure mode and effect analysis by combining the detectability and criticality steps. A hazard score is calculated at the level of the potential causes of failure (Severity × Occurrence × Detection) referenced from a hazard matrix table.10 The HFMEA can be a useful tool in improving care processes, and it can also help improve communication and awareness among key stakeholders. It is particularly useful in health care settings where there are many high-risk processes. Furthermore, it also reinforces a continuous quality improvement (QI) culture in which everyone is attuned to recognizing and preventing failures or problems before they occur.10
The NICU at our institution had been experiencing an increase in the number of CLABSIs. RCA was conducted for each CLABSI episode. This analysis consisted of patient care events and CVC maintenance activity for the 72 hours before a positive blood culture. It also included staffing to patient ratios, precepting, product issues, dressing integrity and hand hygiene practices around CVC maintenance. We could not identify specific causes for CLABSI events using RCA. The HFMEA was considered an alternative approach for proactive risk assessment that had been previously used in other health care settings but not in the NICU. It was hypothesized that this systematic approach of identifying failure modes and action plans for central line placement and maintenance would help reduce CLABSI rates.
The HFMEA initiative was part of an ongoing safety program in our unit. Involvement in QI and safety programs designed to improve clinical care is an expectation of all the staff members. The ethics board at our facility does not require ethical review of QI activities when these procedures involve systems that do not directly involve patients.
The 24-bed, level IIIC NICU and tertiary referral center cares for >650 critically ill infants annually with complex medical and surgical conditions from birth through 6 months of age.11 In addition, patients from home or a long-term care facility are also admitted to the NICU.
Our departmental QI team, which included the director of quality measurement and improvement and a QI consultant, facilitated the HFMEA. For ease of documentation, organization of the data, and to track each step of the HFMEA process, the QI team leveraged the electronic-based QI Path FMEA. This tool was designed specifically for use by hospitals and other health care providers to make the process easier and more effective.
Steps in HFMEA
Team formation. A multidisciplinary team of clinicians from nursing, medicine, surgery, pharmacy, infection prevention, and QI was formed to conduct the assessment and develop improvement interventions. The first meeting was held in March 2011 to discuss the HFMEA process and timeline. Particular focus was placed on ensuring expert representation from various disciplines to bring out the most relevant perspectives and ideas. Roles and responsibilities were clearly identified. The team meticulously followed each step of the HFMEA to understand the current processes, identify failure points, and prioritize areas of focus.
Defining the topic. The goals of HFMEA were discussed, and our team agreed on a reduction in the number of CLABSIs as a result of central line insertion and maintenance in the NICU as the primary focus.
Defining the process flow. Meeting on a weekly basis, the team simulated all steps from line placement to removal and developed a process flow (Fig 1). Evaluation, insertion, maintenance, and removal were defined as 4 high-level steps. Subsequently, substeps were identified for each of these high-level steps.
Failure modes. Next, our team brainstormed to identify failure modes for each of the substeps. A failure mode is a probable error that could occur at each substep. Over the course of 11 weeks, our team met 9 times in 2-hour time slots and identified 67 failure modes (Table 2) in 21 substeps (Fig 1).
Hazard analysis and detection of failure causes. Failure modes are subjective but have quantifiable occurrences. To quantify the failure mode, a hazard score was assigned that was the product of probability of event occurrence, the severity of its impact on the overall process or its stakeholders, and its detectability. Quantification via the hazard score helps prioritize the failure modes identified through the brainstorming session of the HFMEA. Definitions and scores for probability of occurrence, severity of impact, and detectability provided by the QI Path were used as outlined in Table 3.10 Detectability in HFMEA describes the identification and remediation of a failure cause or its consequent failure mode before delivery to the patient. To ensure comprehensive detectability, mechanisms called controls are used that serve as screening mechanisms to detect the failure mode from occurring and preventing it from reaching the patient. For example, team decision, clinician selection, site selection, and timing of placement were all selected as substeps to the high-level step “Evaluation.” Our team then identified failure modes for each of these substeps. For substep site selection, our team decided on 2 probable failure modes that included ideal line not selected and specific product not available. For ideal line not selected, our team assigned a score of 3 for probability of occurrence, a score of 2 for severity, and a score of 2 for detectability, resulting in a hazard score of 12. Hazard scores were calculated once individual components were assigned using failure mode and effect analysis software.
Define actions and measures. As next steps, for each failure mode, risk reduction strategies were identified. This helped us identify action plans for causes with all levels of hazard scores. The team assigned specific actions to individual HFMEA participants congruent with their role, expertise, and experience in the NICU.
To evaluate the effectiveness of HFMEA in reducing CLABSIs, we used the Centers for Disease Control and Prevention, National Healthcare Surveillance Network CLABSI surveillance definitions, methods, and metrics to identify CLABSIs.12 The entire project time was subdivided into a preimplementation phase (March 1–September 30, 2011) when HFMEA project was conceptualized and conducted, implementation phase (October 1–30, 2011) during which the guidelines developed from the HFMEA process were implemented in the NICU and postimplementation (November 1, 2011–July 31, 2012) when guidelines were already in place.
An HFMEA report was developed to display all of the failure modes from the highest to the lowest hazard score. This report identified 67 failure modes in 21 substeps and 146 risk reduction strategies. The failure modes were reviewed and the team applied the Pareto principle (20% of the defects causing 80% of the problems) to respond to hazard scores in the top 20% (Table 2). Furthermore, on close examination, consistent themes emerged that enabled the team to develop a list of the 5 most common failure modes that included contamination, suboptimal environment of care, improper documentation and evaluation of CVC dressing integrity, issues with equipment or supplier, and lack of knowledge. Interventions and education plans for these 5 failure modes were then developed based on the best practices, current policies, and guidelines (Table 4).
Over the course of 1 month (October 2011), 94% of the clinical staff participated in a 30-minute PowerPoint presentation and mandatory education session. The education sessions explained the results of the HFMEA, the proposed changes in the reference tools regarding central line care and maintenance, and the reinforcement of current policies related to infection prevention.13,14 The infection prevention nurse (IPN) conducted all the educational sessions, allowing the information and changes to be streamlined and prevent variability in the information distributed.
Practice changes were implemented on November 1, 2011. Audits for hand hygiene and CVC care that reinforced education and compliance with the standard of care and helped with data collection were performed weekly. For auditing processes, new user-friendly auditing tools were developed that were consistent with the practice changes. All auditors were trained by the IPN to minimize variation in practice and provide valid data. Volunteers from the Infection Control Group were the first to be trained to conduct the audits. Eventually, others were also trained to assist with ongoing audits.
Our education plan included the goal of establishing a culture of acceptance in which peers could give and receive real-time feedback on infection prevention and control practices. We believed staff needed to feel supported and not criticized throughout the education and auditing process. Moreover, unit leaders reinforced the necessity of discussing CVCs during daily patient rounds and changed the format of the rounding worksheet to accommodate this new procedure. A strong presence from both medical and nursing leadership was felt throughout the HMFEA process.
The CLABSI rate was 2.6 per 1000 central line days during both the pre-HFMEA implementation and HFMEA implementation phases and it dropped to 0.8 during the post-HFMEA implementation phase (Table 5). During the post HFMEA implementation phase, the number of days between CLABSI events peaked at 174; this was the longest stretch without a CLABSI in our NICU since 2009. The run chart of CLABSI/1000 line days for each month of the HFMEA process (March 1, 2011–July 31, 2012) is shown in Fig 2. Our central line use rate during the pre- and post-HFMEA implementation phase remained essentially unchanged.
The HFMEA implementation helped strengthen NICU culture through education, setting of expectations, auditing, and reinforcement of infection prevention practices. The staff reported feeling supported and empowered while giving and receiving feedback on infection prevention and control practices. In 2010, data compiled from hand hygiene and central line audits showed a decrease in compliance with infection control practices. This was concurrent with a concerning increase in the frequency of CLABSIs. During the preimplementation phase, the audits of infection control practices continued to be reflective of compliance percentages in the 80% to 85% range. However, during the implementation and postimplementation phases, the compliance increased to the 91% to 96% and has remained in that range. We have achieved 5 consecutive months without a CLABSI following the HFMEA initiative.
The systematic and collaborative approach of the HFMEA allowed our NICU team to identify potential and actual failure modes as well as develop action plans to minimize the occurrence of these failure modes, thereby decreasing the risk of a central line infection. None of the CLABSIs occurred within the 7 days of insertion during both pre- and postimplementation phases of this QI initiative, and therefore our interventions were focused on the CVC maintenance process where most failure modes were identified by the HFMEA. This included efforts toward performing regular audits during CVC tubing change and hand hygiene. In addition, the HFMEA initiative provided an opportunity to incorporate important system-based changes, including creating a CVC Dressing Assessment Group, implementing daily discussion during rounds to evaluate CVC removal, and making changes to the total parenteral nutrition (TPN) delivery system.
The CVC Dressing Assessment Group was created to reeducate staff about the evaluation and documentation of dressing appearance that included proper assessment of dressing integrity and bleeding at the insertion site beneath dressing. In addition, the clinical nurse specialists and IPN started weekly rounds to assess CVC dressings, maintain a log, and take appropriate actions.
Prolonged indwelling central lines pose an increased risk for CLABSIs, but removing a central line at the earliest possible time can be a challenge. The uncertainties about the disease course in a sick NICU patient makes it difficult to advocate for removing an underutilized CVC, defined as not being used for current treatment and present only for a potential future need. The risks and benefits of leaving a CVC in place are based on difficulty replacing the line, duration of indwelling central line, and the timing of possible future intervention(s) needing central line access. The line removal discussions during clinical rounds serve as a constant reminder of the infection risk associated with central lines and prompt providers to weigh the risks and benefits of removal every single day.
HFMEA provided an opportunity to discuss the optimal time of the day for TPN delivery. This was based on the pharmacy’s commitment to a consistent delivery time to the NICU based on staffing and the timing of daily TPN orders. This standard delivery time allowed for nursing to plan the day more efficiently, inform and use available resources more effectively, and limit disruptions to parent-infant bonding.
A philosophical underpinning to HFMEA is to promote and reinforce a culture of continuous QI and safety.15 However, frequent monitoring of health care providers’ infection prevention practices has the potential to have a negative impact on the work environment. Health care providers may experience increased anxiety from fear of punishment for not having followed protocols or best practices. To address this issue, the existing collaborative culture was reinforced by the NICU leadership in various internal meetings from the outset of the initiative, including rewarding individuals with gift cards and team successes with treats, such as pizza parties. This allowed the health care providers to function in a setting that promotes desirable patient care practices and encourages improvements.
The special treatments and procedures performed outside the NICU and the current NHSN definitions for CLABSIs have the potential to influence the incidence and reporting of CLABSIs. Several neonatal procedures including various tests, imaging, treatment, and operations are performed outside NICU where central lines may be accessed by the non-NICU staff that may not follow the same rigorous infection prevention practices. A positive CLABSI within 48 hours from a non-NICU encounter is attributed to the NICU, and this variable could not be addressed by the HFMEA. Furthermore, single positive blood cultures with organisms generally regarded as skin contaminants (e.g., Staphylococcus epidermidis) can possibly indicate a true infection but are not counted as a CLABSI by NHSN surveillance definitions.
Preventing nosocomial infections including CLABSIs remains a major challenge for health care facilities. Identifying and using nonconventional strategies to minimize the occurrence of CLABSIs is what led our team to the HFMEA initiative. The multidisciplinary, systematic approach inherent to the HFMEA helped us identify areas of vulnerability in the care and maintenance of our central lines, thereby reducing CLABSIs. It not only helped reduce the CLABSI rate in our NICU but also reinforced the culture of continuous QI and safety.
The authors acknowledge Tom Leifer from QI Path Failure Mode and Effect Analysis and Dr Jonathan Finkelstein, Kristan Boutwell, and Jamie Harris for their critical reading of the manuscript. We also acknowledge Michelle Labrecque, Caitlin O’Brien, Keri Kucharski, Judy Carter, Meredith Doucette, and Cheryl Toole from the Department of Nursing, Division of Newborn Medicine, and Alana Arnold and Peter Lutz from Department of Pharmacy, Boston Children’s Hospital, for their invaluable input in the HFMEA process.
- Accepted January 10, 2013.
- Address correspondence to Pankaj B Agrawal, Children’s Hospital Boston, 300 Longwood Ave, Hunnewell 4, Boston MA 02115. E-mail:
Ms Chandonnet initiated the process of consulting the quality improvement director, coordinated the multidisciplinary team meetings, revised the audit tools used, participated in and supervised data collection, designed and carried out staff education, participated in drafting the initial manuscript, reviewed and revised the manuscript, and approved the final manuscript as submitted. Dr Kahlon provided the expertise on the health care failure mode and effect analysis (HFMEA) process and facilitated the team meetings, which included process mapping, failure mode identification, hazard scoring, prioritizing failure modes, and creating the final report; she participated in drafting the initial manuscript; and she reviewed, revised, and approved the final manuscript as submitted. Dr Rachh assisted with the mapping process, maintained accurate and detailed minutes of each meeting, created graphs and tables, performed literature searches, and contributed to the final report creation and approved the final manuscript as submitted. Dr DeGrazia supported adherence to infection control practice changes that resulted from HFMEA process; facilitated manuscript development; reviewed, revised, and approved the final manuscript as submitted. Ms Dewitt participated in team meetings, contributed to the initial manuscript, contributed to the tables, and reviewed, revised, and approved the final manuscript as submitted. Ms Flaherty contributed to the initial manuscript, provided infection prevention expertise; participated in team meetings; provided central line–associated blood stream infections occurrence data; contributed to results; and reviewed, revised, and approved the final manuscript as submitted. Ms Spigel participated in team meetings, contributed to the initial manuscript, and reviewed, revised, and approved the final manuscript as submitted. Ms Packard participated in team meetings, contributed to the initial manuscript, and reviewed, revised, and approved the final manuscript as submitted. Ms Casey participated in team meetings, contributed to the initial manuscript, and reviewed, revised, and approved the final manuscript as submitted. Ms Rachwal participated in team meetings, contributed to the initial manuscript, and reviewed and revised the manuscript. Dr Agrawal, a neonatologist, participated in the HFMEA process from the outset through implementation of the recommendations; he helped in drafting the manuscript and edited it frequently until submission; and he approved the final manuscript as submitted.
FINANCIAL DISCLOSURE: The authors have indicated they have no financial relationships relevant to this article to disclose.
FUNDING: No external funding.
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- Copyright © 2013 by the American Academy of Pediatrics