ORIGINAL ARTICLE
Application of Failure Mode Effect Analysis to Improve the Care of Septic Patients Admitted Through the Emergency Department Ahmed Alamry, MD, MHA, FRCPC,*†‡§ Souzan M. Al Owais, RPh, CPHQ,‡ Abdellatif M. Marini, RN, MSc, CPHQ,‡ Hasan Al-Dorzi, MD,*∥ Sami Alsolamy, MD,§∥ and Yaseen Arabi, MD, FCCP, FCCM*∥ Background: Failure mode effect analysis (FMEA) is a proactive multistep tool used to analyze risks, identify failures before they occur, and prioritize preventive measures. Methods: A multidisciplinary team trained on FMEA methodology analyzed the process of treatment of septic patients and recorded processes under 3 major phases (recognition of severe sepsis, referral, and resuscitation). The team identified potential failure modes in each process; assigned severity, occurrence, and detection scores for each; and calculated the risk priority numbers (RPNs). Finally, higher-priority failure modes (RPN of ≥300) were analyzed to redesign the care process. Results: We identified 27 processes and 48 failure modes with a mean RPN of 270. Twenty-two high-risk failures were identified by RPN of 300 or higher. All identified critical processes were related to phase 1 (recognition of sepsis) and phase 3 (resuscitation). The most critical process seemed to be related to the initial workup and treatment of septic patients, with 4 potential failure modes and a total RPN of 1485. Conclusions: Patient safety and care reliability issues are a major concern in health care. This study suggests that tools such as FMEA can enable a detailed analysis of the care process of septic patients by outlining potential failure modes and guiding improvement efforts. Key Words: intensive care unit, emergency care, sepsis, risk assessment, failure mode effect analysis (J Patient Saf 2014;00: 00–00)
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epsis is a systemic, deleterious host response to infection leading to severe sepsis (acute organ dysfunction secondary to documented or suspected infection) and septic shock (severe sepsis plus hypotension not reversed with fluid resuscitation)1; thus, it is responsible for high mortality and morbidity. Severe sepsis and septic shock mortality were reported to range from 25% to 67%,2,3 with wide variation between countries. Furthermore, a recent study that examined mortality due to sepsis in the United States reported a national age-adjusted sepsis mortality of 65.5 per 100,000 persons, with a wide variation between individual states of up to 2-fold.4 In the face of this deadly disease, studies started to appear in the early 2000s showing that, by standardizing care, the outcome of sepsis could be improved.5 Thus, through a transparent scientific methodology, evidence-based guidelines for the management of sepsis were developed and published.6 However, the adaptation From the *College of Medicine, and †College of Public Health and Health Informatics, King Saud bin Abdulaziz University for Health Sciences; and ‡Department of Quality Management, §Department of Emergency Medicine, and ∥Intensive Care Department, King Abdulaziz Medical City, Riyadh, Saudi Arabia. Correspondence: Ahmed Alamry, MD, MHA, FRCPC, King Saud bin Abdulaziz University for Health Sciences, PO Box 22490 MC 2350, Riyadh 11426, Saudi Arabia (e‐mail: [email protected]; [email protected]; [email protected]). The authors disclose no conflict of interest. Copyright © 2014 by Lippincott Williams & Wilkins
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of the guidelines to bedside practice was very low, so the Surviving Sepsis Campaign partnered with the Institute for Healthcare Improvement to develop the “sepsis bundle.”7 In addition, although studies have shown a reduction in mortality with increased compliance with the sepsis bundle,8 the compliance rates remained low. In a recent study that examined the management of severe sepsis in 150 intensive care units (ICUs) in 16 Asian countries, the compliance rates for the resuscitation and management bundles were 7.6% and 3.5%, respectively, with a hospital mortality rate of 44.5%.9 Sepsis management is an example of the increasing complexity with interlinking processes in the clinical management environment, where system failures are more likely to occur. Predicting the likelihood of failures allows measures to be put in place to prevent or mitigate the occurrence of failures and their consequences. One of these proactive management processes is failure mode effect analysis (FMEA), a tool that can be used to study and prioritize the consequences and the frequency of occurrence of failure.10 However, the FMEA system, which has been successfully used in other industries for many decades, especially in high-risk engineering industries (e.g., the aerospace industry), has been adapted into health care only in the past decade or so.11,12 The FMEA was successfully applied in the health care to improve the safety of drug administration,13–19 use of technology and equipment,20–23 different clinical settings like critical care,24–27 and blood transfusion.28 To our knowledge, there is no study that applied FMEA to outline the probability of failures in the treatment of septic patients admitted through the emergency department (ED). This study was part of an institution-wide quality improvement initiative to address the care of septic patients admitted through the ED. A multidisciplinary team representing different departments at our academic medical center was trained to use FMEA methodology. The aim of this study was to examine the process of care of septic patients, with the main purpose of identifying higher-priority potential failure modes as defined by their risk priority numbers (RPNs), and plan system changes in the management process to reduce the risk for patient harms and improve outcomes of sepsis patients admitted through the ED.
Study and Period of Study This is a descriptive study of the use of FMEA at King Abdulaziz Medical City (KAMC), Riyadh. King Abdulaziz Medical City is a 1250-bed university-affiliated tertiary care center in Riyadh, Saudi Arabia, accredited by the Joint Commission International, and receives more than 200,000 ED visits each year. Admissions through the ED represent 46% of the total hospital admissions per year. The ED has 95 beds in different clinical areas and staffed by board-certified emergency physicians. The main ICU at KAMC is a 21-bed closed medical and surgical unit and is staffed by on-site board-certified intensivists on a 24 hours per day, 7 days per week, basis. Residents and fellows from different www.journalpatientsafety.com
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specialties rotate in the ED and ICU as part of their training requirements. Nursing staff–patient ratio is 1:1 in the ICU and the critical care area of the ED. All medication and orders are entered using computerized physician order entry (CPOE). The study occurred during the months of March to May 2013 as part of KAMC Quality Improvement Program. This study was part of a quality improvement project, and there was no human subject intervention; thus, it did not require ethical approval from our institutional review board.
Team Composition, Training, and Goals A multidisciplinary team consisting of critical care and emergency medicine physicians and nurses, as well as quality management specialists, was trained to use FMEA methodology, to (1) analyze the process of treatment of septic patients and record processes under 3 major phases (recognition of sepsis, referral, and resuscitation); (2) identify potential failure modes in each process and their effects, assign severity, occurrence, and detection scores for each failure mode, and calculate the RPNs by multiplying the 3 scores; and (3) analyze failure mode causes and make recommendations to redesign the process taking into account the 3 scores and RPN. Table 1 represents the chronology of the team effort for 4 sessions. The team had worked together as part of a quality improvement project. The main goals of the team were to identify higher-priority potential failure modes as defined by RPN of 300 or higher and to plan system changes in the management process, to reduce the risk for patient harm and improve outcomes of sepsis patients admitted through the ED.
Analysis of the Process of Treatment of Septic Patients The process for treating septic patients was characterized by identifying key elements of the process as well as the type of health care worker (physicians, nurses) and department (ED, ICU, laboratory, pharmacy) participating in that element. These processes were grouped under 3 major phases (recognition, referral, and resuscitation), Thereafter, following the steps of FMEA (Table 2), we first identified the ways in which each process might fail. To quantify these failures, values between 1 and 10 were assigned to 3 features of each failure mode: the risk for injury should a failure result (severity), the frequency with which failures occur (occurrence), and the probability that a failure goes undetected before an injury results (detection). The process of allocating the values included a literature search, reviewing examples of score assignments for probability of occurrence from other industries29 (example shown in Table 3), and subjective assessment of expert team members. Numbers were assigned according to a specific definition as follows: values of 1 meant failure effects that will rarely cause any injury, probability of failure that is very low, and failures that have very high
TABLE 2. FMEA Steps Identify key elements and steps in the process. Identify modes of failure. For each failure mode, score the following on a 10-point scale: Severity (S) of failure should it not be detected Likelihood of occurrence (O) for each failure based on experience, measurement, and literature Likelihood that failures will escape detection (D) before causing harm For each failure mode, calculate RPN = S O D. Prioritize remedial measures for elements with the highest RPN. International Joint Commission Resources, The Joint Commission.10
likelihoods of being detected before causing an effect, and values of 10 meant a failure that would result in death, likelihood of failures is almost certain, and failures that have no or very low chance of being detected before causing an effect. The riskiness of each failure mode is indicated as an RPN, which is calculated as the product of the severity (S), occurrence (O), and detectability (D) scores (RPN = S O D). The RPN identifies those modes that are the most likely contributors to clinically serious failures. The maximum attainable RPN is 1000.
RESULTS Description of the Original Process The team grouped the original process of treating septic patients admitted through the ED into 3 main phases: (1) recognition of severe sepsis patients, (2) referral of septic patients to sepsis management, and (3) resuscitation of septic patients (Fig. 1). Each phase was then analyzed to its various processes, identifying potential failure modes for each process. The number of processes varied per phase depending on the aim of the phase and value intended, 27 processes were identified, and many were vulnerable to multiple failure modes. The calculation of RPNs was used to highlight the processes and failure modes that pose the greatest risk for harm.
Failure Modes A total of 48 failure modes were identified (Table 4), with a total RPN of 13,485. The mean RPN was 270, a total of 50% of the failure modes had an RPN score of greater than or equal to 144, the minimum score was 14, and the maximum was 729. None of the processes in the treatment of septic patients were free of potential failure modes, so to make the list of failure modes manageable, the team arbitrarily decided to use a cutoff of 300 RPN for high-risk failures; using that cutoff identified 22 high-risk failures
TABLE 1. Chronology of FMEA Team Sessions
TABLE 3. Score Assignments for the Probability of Occurrence
Session
Likelihood
Date
Activity
Session 1 March 24, 2013 Introduction to FMEA and team training Session 2 March 31, 2013 Process mapping (phases and processes) and identifying failures modes Session 3 April 1, 2013 Scoring of the failure modes and calculation of RPN Session 4 April 15, 2013 Prioritizing of failure modes and recommendation of remedial measures
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Remote Low Moderate High Very high
Data
Score
Probability
No known occurrence Possible but no data Documented but infrequent Documented and frequent Documented, almost certain
1 2–4 5–6 7–8 9–10
1/10000 1/5000 1/200 1/100 1/20
Semiconductor Manufacturing Technology.29
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FMEA to Improve the Care of Septic Patients
FIGURE 1. The 3 main phases of treating septic patients admitted through the ED (recognize, refer, and resuscitate).
(46% of all failures ) (Table 5). All identified critical processes were related to phase 1 (recognition of sepsis) and phase 3 (resuscitation); none were found in the phase 2 (referral) because of a low occurrence and high detectability of failure modes in that phase. The most critical process seemed to be related to the initial workup and treatment of septic patients; 4 failure modes were associated with that process, which are as follows: delays in ordering essential laboratory tests, collecting laboratory samples, receiving laboratory results, and initiating the sepsis bundle, and combined, these carried a total RPN of 1485. The highest risk failure mode was in the delay of inserting a central line, which carried an RPN of 729. Other significant failure modes consisted of delay in patient evaluation by a senior member of the medical team, failure to monitor central venous pressure, the absence of workup during patient waiting time, and delay in ordering and administering of broadspectrum antibiotics.
Risk-Reduction Strategies The team developed plans and implemented some new corrective actions focused only on the higher-risk failure modes identified; a selected set of those corrective actions are summarized in Table 6. Some of the remediation strategies target all phases of sepsis management, whereas others target some specific highrisk processes. One of these measures of improvement was the introduction of an electronic (E)-Alert system, which took into account the initial patient vital signs and laboratory values to initiate a sepsis alert for the treating physician and nurse. The other initiative was sending a weekly electronic mobile text message to all physicians in the ICU and ED summarizing the compliance rate with sepsis care bundle, the elements with the lowest compliance, and an encouraging quote for the physician on the importance of compliance with the care bundle in saving lives. In addition, to © 2014 Lippincott Williams & Wilkins
simplify the processes, the team designed an order set in the CPOE containing all elements of the sepsis bundle that could be activated via a single click by the treating physician, thus reducing the error of omission in the process of care.
DISCUSSION We performed FMEA at a large academic medical center in Saudi Arabia in the critical care and emergency medicine departments to understand how the potential vulnerabilities associate with the process of treatment of septic patients admitted through the ED. We found that the processes of care were vulnerable to many failure modes across all phases of management, and the identified high-risk failure modes spanned through phases 1 (recognition of severe sepsis patients) and 3 (resuscitation of septic patients) of the management process, therefore representing a potential target for improvement. In our experience, FMEA proved to be an effective method for analyzing the complex process of treating septic patients admitted through the ED. It enabled a multidisciplinary team of health care professionals to generate a comprehensive overview of the different steps in the process and a thorough assessment and ranking (in terms of calculating the RPN for each failure mode) of the steps at risk, and they were able to promote corrective actions to prevent adverse events from occurring. A significant advantage of FMEA is the type of information collected that makes it easy to identify the priorities of any actions required for improvement, lowering the risk for failure in the patient treatment process. It enabled the recommendation and consensus on changes to the routine practice, mostly owing to the team’s approach inherited in the FMEA methodology. At our institution, FMEA approach was chosen as a method for conducting a risk analysis on treatment of septic patients because it allowed the opportunity for a more comprehensive study of the process www.journalpatientsafety.com
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TABLE 4. The Phases of Sepsis Management and Process and Potential Failure Modes Identified SN 1.1 1.2
1.3 1.4 1.5
1.6 1.7
1.8
1.9
1.10
1.11
1.12
1.13
1.14
Process
Failure Modes
The nurse triages the patient Triage to wrong level; and sends to registration delay in triage in reception area Patient registration Delay in registration; wrong registration (wrong patients) The patient waits in Long waiting time, the waiting area unmonitored patients after registration during waiting time Physician triages patient Triage to wrong level; delay in triage process The patient waits in Long waiting time; no the waiting area after workup during physician triage waiting time The patient is admitted Delay in entering vital to adult care or urgent signs into the hospital care units in the ED information system The ED bedside nurse Lack of workup while assesses the patient waiting to be seen; missed (vital signs and entering of vital signs history taking) every 2 hr The ED physician Unable to detect sepsis signs (resident) assesses the patient (history and physical exam) The ED physician Delay in assessment (consultant) assesses patients (history and physical exam) The ED physician enters Delay in ordering laboratory the investigations and test; delay in collecting initial treatment into laboratory sample; delay in the system receiving laboratory result; delay in treating sepsis The ED physician identifies Delay in identifying the admitting service the admitting consultant; delay in acceptance from admitting consultant The junior resident in Wrong assessment by the admitting service the junior physician; delay assesses the patient in assessment by the junior physician The senior resident from Wrong assessment by the admitting service the senior physician; delay assesses the patient in assessment by the senior physician The treating team decides Delay in referral to to refer the patient to the ICU service the critical care team
SN
Process
Failure Modes
2.1 The senior resident from the admitting service refers the patient to ICU resident 2.2 The ICU resident refers the patient to ICU staff physician 2.3 The ICU staff physician refers the patient to ICU consultant 2.4 The ICU consultant assesses the patient and confirms sepsis 2.5 The ICU consultant orders additional workups 3.1 Measuring lactate level 3.2 Obtaining 2 sets of blood cultures before administering antibiotics 3.3 Ordering and administering of IV fluid bolus
3.4 Ordering and administering of broad-spectrum antibiotics 3.5 Physician inserts a central line (if indicated)
The admitting service resident delays the referral to ICU resident The ICU resident delays the referral to ICU staff physician The staff physician delays the referral to ICU consultant Diagnostic error Delayed additional workup
Delay ordering lactate level; delay collecting lactate sample; delay receiving lactate result Failure to obtain and send 2 sets of blood culture
Inappropriate selection of type of fluid bolus; inappropriate volume of fluid bolus; delay in ordering fluid bolus Inappropriate selection of type of antibiotics; delays in ordering, dispensing, and administering antibiotics Delay in inserting central line, failure to insert central line
3.6 Monitoring of CVP and venous saturation
Failure to monitor CVP
3.7 Ordering and administering of vasopressors
Delay in ordering vasopressors, delay in dispensing vasopressors; delay in administering vasopressors Delay in identifying the source of infection; failure to control source of infection
3.8 Identification and control of infection source
CVP indicates central venous pressure; IV, intravenous; SN, serial number of the failure mode.
than other tools that are still being performed, such as root cause analysis on adverse events identified by means of mortality and morbidity reviews and voluntary electronic incident reporting. This report is one of the few published so far on the use of FMEA in clinical settings, but to our knowledge, this is the first study that uses FMEA to outline the vulnerabilities in the care process of septic patients admitted through the ED. In a recent report, Asefzadeh et al24 studied the uses of FMEA in the ICU setting and concluded that using the tool can identify risks that are preventable. Another study in the dialysis unit showed that FMEA can identify critical actions needed to reduce the clinical risk of
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dialysis patients.30 In addition, in the pediatric oncology inpatients setting, health care failure mode and effect analysis (a variant of FMEA) was shown to be a useful method for detecting failure modes, and the patient or the parent can contribute to the process and be part of the team.27 The FMEA was also used successfully in the treatment of trauma patients, where it was reported to help in systematically identifying and prioritizing risks to patient safety from errors of registration.26 In addition, in a recent study on the use of FMEA in the treatment planning of scanned proton beam radiotherapy, the application of FMEA identified strategies for risk mitigation to improve the safety of patients.20 The method © 2014 Lippincott Williams & Wilkins
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FMEA to Improve the Care of Septic Patients
TABLE 5. The 22 High-Risk Failure Modes and Their RPN SN 1.3.a 1.3.b 1.5.a 1.5.b 1.6.b 1.7.a 1.10.a 1.10.c 1.10.d 1.12.b 1.13.a 1.13.b 3.1.a 3.1.c 3.2.a 3.3.b 3.4.b 3.4.c 3.5.a 3.6.a 3.7.b 3.8.a
Failure Mode
Severity
Occurrence
Detection
RPN
Long waiting time Unmonitored patients during waiting time Long waiting time No workup during waiting time Lack of work up while waiting to be seen Missed entering of vital signs every 2 hr Delay in ordering laboratory tests Delay in receiving laboratory results Delay in treating sepsis Delay in assessment by the junior physician Wrong assessment by the senior physician Delay in assessment by the senior physician Delay in ordering serum lactate level Delay in receiving serum lactate result Failure to obtain and send 2 sets of blood culture Inappropriate volume of fluid bolus Delay in ordering antibiotics Delay in dispensing antibiotics Delay in inserting central line Failure to monitor central venous pressure Delay in dispensing vasopressors Delay in identifying source of infection
7 7 7 7 7 7 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9
9 9 9 10 9 7 5 8 6 8 5 8 5 8 8 8 8 8 9 9 8 7
7 7 6 9 9 9 9 8 8 5 9 9 8 8 8 8 8 8 9 8 8 7
441 441 378 630 567 441 405 576 432 360 405 648 360 576 576 576 576 576 729 648 576 441
SN, indicates serial number of the failure mode.
was also recommended and required by the Joint Commission International.31 In the complex process of treating septic patients, the single process with the highest risk for error was the initial workup and treatment of septic patients. Most of the risk for errors in this activity seemed to be related to the delays in ordering essential laboratory tests, collecting laboratory samples, receiving laboratory results, and initiating the sepsis bundle. The mitigation actions adopted in our institution to address these issues were implementing an E-Alert system to identify patients with signs of severe sepsis (systemic inflammatory response syndrome plus 1 organ failure indicator) and designing an order set in the CPOE that contains all the elements of the sepsis bundle,1 which could be activated by the treating physicians via a single click. Therefore, system-initiated alerts, simplification, and standardization were adapted as shown by the literature to improve the reliability of the care process.32 The validity of FMEA as a tool used in health care setting has been questioned in the literature recently, especially its content and criterion validity.33 Although we acknowledge that FMEA proved to be a useful tool in aiding our multidisciplinary team to map and better understand the process of care of septic patients admitted through the ED, and with the aim of improving patient safety, we used other methodologies such as electronic incident reporting, analysis, and trending of these reports to prioritize improvement efforts.34 We use the FMEA as part of a quality improvement project, to prioritize areas in the process of care of septic patients admitted through the ED. Using this analysis, one of the recommendations of the study was to improve recognition of sepsis, so an E-Alert system was designed to alert health care providers once patients’ vital signs or laboratory work suggests sepsis. That improved substantially the diagnosis of sepsis and severe sepsis before the patient © 2014 Lippincott Williams & Wilkins
developed septic shock. The second large category was sepsis resuscitation, and as such, we developed a sepsis response team to address the challenges identified by FMEA. This study has some limitations. As a single-institution study, the findings reflect the care delivery model at the ICU and ED, and although many features are common to other health care TABLE 6. Selected Corrective Actions and the Phases Targeted in Sepsis Management Corrective Action
Targeted Phase
Increase awareness through educational sessions Standardization of sepsis management Central line guidelines Standardize training on central line insertion Vasopressor use guidelines Clinical pathway for management of sepsis Improve communication Weekly electronic mobile text message to all physicians, reporting compliance rates with sepsis bundle Standardize the hand over process for the sepsis team Improve access to care Establishing a sepsis team Creating a sepsis bed in the ICU Using information technology Creating an E-Alert for detecting septic patient Standardizing a sepsis bundle activated by 1 click in the CPOE system
Phase 1, 2, 3 Phase 1, 2, 3 Phase 3 Phase 3 Phase 3 Phase 1, 2, 3 Phase 1, 2, 3 Phase 1, 2, 3 Phase 2 Phase 2, 3 Phase 2 Phase 3 Phase 1, 2, 3 Phase 1 Phase 2, 3
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organizations, others reflect local procedures, resources, and norms. For these reasons, the results might not be completely generalizable to other organizations. Moreover, FMEA identifies higher risk for failure modes through calculating RPN, and in our experience and what was reported in the literature, the estimation of occurrence and detectability is highly dependent on the team member’s experience and judgment. Therefore, it is important to create a multidisciplinary team of frontline health care professionals who know perfectly the process that can improve the consistency of FMEA.
CONCLUSIONS In the current health care environment, patient safety and care reliability are a major concern, especially in the high-risk population such as septic patients. The presented data suggest that tools such as FMEA can enable a detailed analysis of the complex care process of septic patients, to outline potential failure modes and highlight which risks have the greatest concern, thus guiding improvement efforts to focus on high-leverage processes. REFERENCES 1. Dellinger RP, Levy MM, Rhodes A, et al. Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock: 2012. Crit Care Med. 2013;41:580–637. 2. Na S, Kuan WS, Mahadevan M, et al. Implementation of early goal-directed therapy and the surviving sepsis campaign resuscitation bundle in Asia. Int J Qual Health Care. 2012;24:452–462. 3. Vincent J-L, Sakr Y, Sprung CL, et al. Sepsis in European intensive care units: results of the SOAP study. Crit Care Med. 2006;34:344–353. 4. Wang HE, Devereaux RS, Yealy DM, et al. National variation in United States sepsis mortality: a descriptive study. Int J Health Geogr. 2010;9:9. 5. Rivers E, Nguyen B, Havstad S, et al. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001;345: 1368–1377. 6. Dellinger RP, Carlet JM, Masur H, et al. Surviving Sepsis Campaign guidelines for management of severe sepsis and septic shock. Crit Care Med. 2004;32:858–873. 7. Levy MM, Pronovost PJ, Dellinger RP, et al. Sepsis change bundles: converting guidelines into meaningful change in behavior and clinical outcome. Crit Care Med. 2004;32(suppl 11):S595–S597. 8. Levy MM, Dellinger RP, Townsend SR, et al. The Surviving Sepsis Campaign: results of an international guideline-based performance improvement program targeting severe sepsis. Crit Care Med. 2010;38:367–374. 9. Phua J, Koh Y, Du B, et al. Management of severe sepsis in patients admitted to Asian intensive care units: prospective cohort study. BMJ. 2011;342:d3245. 10. International JCRJC. Failure Mode and Effects Analysis in Health Care: Proactive Risk Reduction. 3rd ed. Terrace, IL: Joint Commission Resources, 2010. 11. DeRosier J, Stalhandske E, Bagian J, et al. Using Health Care Failure Mode and Effect Analysis™: The VA National Center for Patient Safety’s Prospective Risk Analysis System. Jt Comm J Qual Improv. 2002;27:248–267. 12. Thornton E, Brook OR, Mendiratta-Lala M, et al. Application of failure mode and effect analysis in a radiology department. Radiographics. 2011;31:281–293. 13. Lago P, Bizzarri G, Scalzotto F, et al. Use of FMEA analysis to reduce risk of errors in prescribing and administering drugs in paediatric wards: a quality improvement report. BMJ Open. 2012;2:1–10.
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14. Weingart SN, Spencer J, Buia S, et al. Medication safety of five oral chemotherapies: a proactive risk assessment. J Oncol Pract. 2011;7:2–6. 15. Adachi W, Lodolce AE. Use of failure mode and effects analysis in improving the safety of i.v. drug administration. Am J Health Syst Pharm. 2005;62:917–920. 16. Bonnabry P, Cingria L, Sadeghipour F, et al. Use of a systematic risk analysis method to improve safety in the production of pediatric parental nutrition solutions. Qual Saf Health Care. 2005;14:93–98. 17. Esmail R, Cummings C, Dersch D, et al. Using Healthcare Failure Mode and Effect Analysis tool to review the process of ordering and administrating potassium chloride and potassium phosphate. Healthc Q. 2005;8:73–80. 18. Kunac DL, Reith DM. Identification of priorities for medication safety in neonatal intensive care. Drug Saf. 2005;28:251–261. 19. Apkon M, Leonard J, Probst L, et al. Design of a safer approach to intravenous drug infusions: failure mode effects analysis. Qual Saf Health Care. 2004;13:265–271. 20. Cantone MC, Ciocca M, Dionisi F, et al. Application of failure mode and effects analysis to treatment planning in scanned proton beam radiotherapy. Radiat Oncol. 2013;8:127. 21. Espond MAD, Ugin DEP, Angeat CLRI, et al. A risk analysis method to evaluate the impact of a computerized provider order entry system on patient safety. J Am Med Inform Assoc. 2008;15:453–460. 22. Wetterneck TB, Skibinski KA, Roberts TL, et al. Using failure mode and effects analysis to plan implementation of smart i.v. pump technology. Am J Health Syst Pharm. 2006;63:1528–1538. 23. Kimehi-Woods J, Shultz JP. Using HFMEA to assess potential for patient harm from tubing misconnections. Jt Comm J Qual Patient Saf. 2006;32:373–381. 24. Asefzadeh S, Yarmohammadian MH, Nikpey A, et al. Clinical risk assessment in intensive care unit. Int J Prev Med. 2013;4:592–598. 25. Bonfant G, Belfanti P, Paternoster G, et al. Clinical risk analysis with failure mode and effect analysis (FMEA ) model in a dialysis unit. 2010;23:111–118. 26. Day S, Dalto J, Fox J, et al. Utilization of failure mode effects analysis in trauma patient registration. Qual Manag Health Care. 2007;16:342–348. 27. Van Tilburg CM, Leistikow IP, Rademaker CM, et al. Health Care Failure Mode and Effect Analysis: a useful proactive risk analysis in a pediatric oncology ward. Qual Saf Health Care. 2006;15:58–63. 28. Burgmeier J. Failure mode and effect analysis: an application in reducing risk in blood transfusion. Jt Comm J Qual Improv. 2002;28:331–339. 29. SEMATECH. Failure Mode and Effects Analysis (FMEA): a guide for continuous improvement for the semiconductor equipment industry. 1992. Cited October 20, 2013. p. 36. Available at: http://www.sematech.org/ docubase/document/0963beng.pdf. Accessed October 20, 2013. 30. Bonfant G, Belfanti P, Paternoster G, et al. Clinical risk analysis with failure mode and effect analysis (FMEA) model in a dialysis unit. J Nephrol. 2010;23:111–118. 31. Joint Commission International. Joint Commission International Accreditation Standards for Hospitals. 4th ed. Terrace, IL: Joint Commission Resources, 2011. 32. Nolan T, Resar R, Haraden CGF. Improving the Reliability of Health Care. IHI Innovation Series. Cambridge, MA, 2004. 33. Shebl NA, Franklin BD, Barber N. Failure mode and effects analysis outputs: are they valid? BMC Health Serv Res. 2012;12:150. 34. Arabi Y, Alamry A, Al Owais SM, et al. Incident reporting at a tertiary care hospital in Saudi Arabia. J Patient Saf. 2012;8:81–87.
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Application of Failure Mode Effect Analysis to Improve the Care of Septic Patients Admitted Through the Emergency Department Ahmed Alamry, MD, MHA, FRCPC,*†‡§ Souzan M. Al Owais, RPh, CPHQ,‡ Abdellatif M. Marini, RN, MSc, CPHQ,‡ Hasan Al-Dorzi, MD,*∥ Sami Alsolamy, MD,§∥ and Yaseen Arabi, MD, FCCP, FCCM*∥ Background: Failure mode effect analysis (FMEA) is a proactive multistep tool used to analyze risks, identify failures before they occur, and prioritize preventive measures. Methods: A multidisciplinary team trained on FMEA methodology analyzed the process of treatment of septic patients and recorded processes under 3 major phases (recognition of severe sepsis, referral, and resuscitation). The team identified potential failure modes in each process; assigned severity, occurrence, and detection scores for each; and calculated the risk priority numbers (RPNs). Finally, higher-priority failure modes (RPN of ≥300) were analyzed to redesign the care process. Results: We identified 27 processes and 48 failure modes with a mean RPN of 270. Twenty-two high-risk failures were identified by RPN of 300 or higher. All identified critical processes were related to phase 1 (recognition of sepsis) and phase 3 (resuscitation). The most critical process seemed to be related to the initial workup and treatment of septic patients, with 4 potential failure modes and a total RPN of 1485. Conclusions: Patient safety and care reliability issues are a major concern in health care. This study suggests that tools such as FMEA can enable a detailed analysis of the care process of septic patients by outlining potential failure modes and guiding improvement efforts. Key Words: intensive care unit, emergency care, sepsis, risk assessment, failure mode effect analysis (J Patient Saf 2014;00: 00–00)
S
epsis is a systemic, deleterious host response to infection leading to severe sepsis (acute organ dysfunction secondary to documented or suspected infection) and septic shock (severe sepsis plus hypotension not reversed with fluid resuscitation)1; thus, it is responsible for high mortality and morbidity. Severe sepsis and septic shock mortality were reported to range from 25% to 67%,2,3 with wide variation between countries. Furthermore, a recent study that examined mortality due to sepsis in the United States reported a national age-adjusted sepsis mortality of 65.5 per 100,000 persons, with a wide variation between individual states of up to 2-fold.4 In the face of this deadly disease, studies started to appear in the early 2000s showing that, by standardizing care, the outcome of sepsis could be improved.5 Thus, through a transparent scientific methodology, evidence-based guidelines for the management of sepsis were developed and published.6 However, the adaptation From the *College of Medicine, and †College of Public Health and Health Informatics, King Saud bin Abdulaziz University for Health Sciences; and ‡Department of Quality Management, §Department of Emergency Medicine, and ∥Intensive Care Department, King Abdulaziz Medical City, Riyadh, Saudi Arabia. Correspondence: Ahmed Alamry, MD, MHA, FRCPC, King Saud bin Abdulaziz University for Health Sciences, PO Box 22490 MC 2350, Riyadh 11426, Saudi Arabia (e‐mail: [email protected]; [email protected]; [email protected]). The authors disclose no conflict of interest. Copyright © 2014 by Lippincott Williams & Wilkins
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of the guidelines to bedside practice was very low, so the Surviving Sepsis Campaign partnered with the Institute for Healthcare Improvement to develop the “sepsis bundle.”7 In addition, although studies have shown a reduction in mortality with increased compliance with the sepsis bundle,8 the compliance rates remained low. In a recent study that examined the management of severe sepsis in 150 intensive care units (ICUs) in 16 Asian countries, the compliance rates for the resuscitation and management bundles were 7.6% and 3.5%, respectively, with a hospital mortality rate of 44.5%.9 Sepsis management is an example of the increasing complexity with interlinking processes in the clinical management environment, where system failures are more likely to occur. Predicting the likelihood of failures allows measures to be put in place to prevent or mitigate the occurrence of failures and their consequences. One of these proactive management processes is failure mode effect analysis (FMEA), a tool that can be used to study and prioritize the consequences and the frequency of occurrence of failure.10 However, the FMEA system, which has been successfully used in other industries for many decades, especially in high-risk engineering industries (e.g., the aerospace industry), has been adapted into health care only in the past decade or so.11,12 The FMEA was successfully applied in the health care to improve the safety of drug administration,13–19 use of technology and equipment,20–23 different clinical settings like critical care,24–27 and blood transfusion.28 To our knowledge, there is no study that applied FMEA to outline the probability of failures in the treatment of septic patients admitted through the emergency department (ED). This study was part of an institution-wide quality improvement initiative to address the care of septic patients admitted through the ED. A multidisciplinary team representing different departments at our academic medical center was trained to use FMEA methodology. The aim of this study was to examine the process of care of septic patients, with the main purpose of identifying higher-priority potential failure modes as defined by their risk priority numbers (RPNs), and plan system changes in the management process to reduce the risk for patient harms and improve outcomes of sepsis patients admitted through the ED.
Study and Period of Study This is a descriptive study of the use of FMEA at King Abdulaziz Medical City (KAMC), Riyadh. King Abdulaziz Medical City is a 1250-bed university-affiliated tertiary care center in Riyadh, Saudi Arabia, accredited by the Joint Commission International, and receives more than 200,000 ED visits each year. Admissions through the ED represent 46% of the total hospital admissions per year. The ED has 95 beds in different clinical areas and staffed by board-certified emergency physicians. The main ICU at KAMC is a 21-bed closed medical and surgical unit and is staffed by on-site board-certified intensivists on a 24 hours per day, 7 days per week, basis. Residents and fellows from different www.journalpatientsafety.com
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specialties rotate in the ED and ICU as part of their training requirements. Nursing staff–patient ratio is 1:1 in the ICU and the critical care area of the ED. All medication and orders are entered using computerized physician order entry (CPOE). The study occurred during the months of March to May 2013 as part of KAMC Quality Improvement Program. This study was part of a quality improvement project, and there was no human subject intervention; thus, it did not require ethical approval from our institutional review board.
Team Composition, Training, and Goals A multidisciplinary team consisting of critical care and emergency medicine physicians and nurses, as well as quality management specialists, was trained to use FMEA methodology, to (1) analyze the process of treatment of septic patients and record processes under 3 major phases (recognition of sepsis, referral, and resuscitation); (2) identify potential failure modes in each process and their effects, assign severity, occurrence, and detection scores for each failure mode, and calculate the RPNs by multiplying the 3 scores; and (3) analyze failure mode causes and make recommendations to redesign the process taking into account the 3 scores and RPN. Table 1 represents the chronology of the team effort for 4 sessions. The team had worked together as part of a quality improvement project. The main goals of the team were to identify higher-priority potential failure modes as defined by RPN of 300 or higher and to plan system changes in the management process, to reduce the risk for patient harm and improve outcomes of sepsis patients admitted through the ED.
Analysis of the Process of Treatment of Septic Patients The process for treating septic patients was characterized by identifying key elements of the process as well as the type of health care worker (physicians, nurses) and department (ED, ICU, laboratory, pharmacy) participating in that element. These processes were grouped under 3 major phases (recognition, referral, and resuscitation), Thereafter, following the steps of FMEA (Table 2), we first identified the ways in which each process might fail. To quantify these failures, values between 1 and 10 were assigned to 3 features of each failure mode: the risk for injury should a failure result (severity), the frequency with which failures occur (occurrence), and the probability that a failure goes undetected before an injury results (detection). The process of allocating the values included a literature search, reviewing examples of score assignments for probability of occurrence from other industries29 (example shown in Table 3), and subjective assessment of expert team members. Numbers were assigned according to a specific definition as follows: values of 1 meant failure effects that will rarely cause any injury, probability of failure that is very low, and failures that have very high
TABLE 2. FMEA Steps Identify key elements and steps in the process. Identify modes of failure. For each failure mode, score the following on a 10-point scale: Severity (S) of failure should it not be detected Likelihood of occurrence (O) for each failure based on experience, measurement, and literature Likelihood that failures will escape detection (D) before causing harm For each failure mode, calculate RPN = S O D. Prioritize remedial measures for elements with the highest RPN. International Joint Commission Resources, The Joint Commission.10
likelihoods of being detected before causing an effect, and values of 10 meant a failure that would result in death, likelihood of failures is almost certain, and failures that have no or very low chance of being detected before causing an effect. The riskiness of each failure mode is indicated as an RPN, which is calculated as the product of the severity (S), occurrence (O), and detectability (D) scores (RPN = S O D). The RPN identifies those modes that are the most likely contributors to clinically serious failures. The maximum attainable RPN is 1000.
RESULTS Description of the Original Process The team grouped the original process of treating septic patients admitted through the ED into 3 main phases: (1) recognition of severe sepsis patients, (2) referral of septic patients to sepsis management, and (3) resuscitation of septic patients (Fig. 1). Each phase was then analyzed to its various processes, identifying potential failure modes for each process. The number of processes varied per phase depending on the aim of the phase and value intended, 27 processes were identified, and many were vulnerable to multiple failure modes. The calculation of RPNs was used to highlight the processes and failure modes that pose the greatest risk for harm.
Failure Modes A total of 48 failure modes were identified (Table 4), with a total RPN of 13,485. The mean RPN was 270, a total of 50% of the failure modes had an RPN score of greater than or equal to 144, the minimum score was 14, and the maximum was 729. None of the processes in the treatment of septic patients were free of potential failure modes, so to make the list of failure modes manageable, the team arbitrarily decided to use a cutoff of 300 RPN for high-risk failures; using that cutoff identified 22 high-risk failures
TABLE 1. Chronology of FMEA Team Sessions
TABLE 3. Score Assignments for the Probability of Occurrence
Session
Likelihood
Date
Activity
Session 1 March 24, 2013 Introduction to FMEA and team training Session 2 March 31, 2013 Process mapping (phases and processes) and identifying failures modes Session 3 April 1, 2013 Scoring of the failure modes and calculation of RPN Session 4 April 15, 2013 Prioritizing of failure modes and recommendation of remedial measures
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Remote Low Moderate High Very high
Data
Score
Probability
No known occurrence Possible but no data Documented but infrequent Documented and frequent Documented, almost certain
1 2–4 5–6 7–8 9–10
1/10000 1/5000 1/200 1/100 1/20
Semiconductor Manufacturing Technology.29
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FMEA to Improve the Care of Septic Patients
FIGURE 1. The 3 main phases of treating septic patients admitted through the ED (recognize, refer, and resuscitate).
(46% of all failures ) (Table 5). All identified critical processes were related to phase 1 (recognition of sepsis) and phase 3 (resuscitation); none were found in the phase 2 (referral) because of a low occurrence and high detectability of failure modes in that phase. The most critical process seemed to be related to the initial workup and treatment of septic patients; 4 failure modes were associated with that process, which are as follows: delays in ordering essential laboratory tests, collecting laboratory samples, receiving laboratory results, and initiating the sepsis bundle, and combined, these carried a total RPN of 1485. The highest risk failure mode was in the delay of inserting a central line, which carried an RPN of 729. Other significant failure modes consisted of delay in patient evaluation by a senior member of the medical team, failure to monitor central venous pressure, the absence of workup during patient waiting time, and delay in ordering and administering of broadspectrum antibiotics.
Risk-Reduction Strategies The team developed plans and implemented some new corrective actions focused only on the higher-risk failure modes identified; a selected set of those corrective actions are summarized in Table 6. Some of the remediation strategies target all phases of sepsis management, whereas others target some specific highrisk processes. One of these measures of improvement was the introduction of an electronic (E)-Alert system, which took into account the initial patient vital signs and laboratory values to initiate a sepsis alert for the treating physician and nurse. The other initiative was sending a weekly electronic mobile text message to all physicians in the ICU and ED summarizing the compliance rate with sepsis care bundle, the elements with the lowest compliance, and an encouraging quote for the physician on the importance of compliance with the care bundle in saving lives. In addition, to © 2014 Lippincott Williams & Wilkins
simplify the processes, the team designed an order set in the CPOE containing all elements of the sepsis bundle that could be activated via a single click by the treating physician, thus reducing the error of omission in the process of care.
DISCUSSION We performed FMEA at a large academic medical center in Saudi Arabia in the critical care and emergency medicine departments to understand how the potential vulnerabilities associate with the process of treatment of septic patients admitted through the ED. We found that the processes of care were vulnerable to many failure modes across all phases of management, and the identified high-risk failure modes spanned through phases 1 (recognition of severe sepsis patients) and 3 (resuscitation of septic patients) of the management process, therefore representing a potential target for improvement. In our experience, FMEA proved to be an effective method for analyzing the complex process of treating septic patients admitted through the ED. It enabled a multidisciplinary team of health care professionals to generate a comprehensive overview of the different steps in the process and a thorough assessment and ranking (in terms of calculating the RPN for each failure mode) of the steps at risk, and they were able to promote corrective actions to prevent adverse events from occurring. A significant advantage of FMEA is the type of information collected that makes it easy to identify the priorities of any actions required for improvement, lowering the risk for failure in the patient treatment process. It enabled the recommendation and consensus on changes to the routine practice, mostly owing to the team’s approach inherited in the FMEA methodology. At our institution, FMEA approach was chosen as a method for conducting a risk analysis on treatment of septic patients because it allowed the opportunity for a more comprehensive study of the process www.journalpatientsafety.com
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TABLE 4. The Phases of Sepsis Management and Process and Potential Failure Modes Identified SN 1.1 1.2
1.3 1.4 1.5
1.6 1.7
1.8
1.9
1.10
1.11
1.12
1.13
1.14
Process
Failure Modes
The nurse triages the patient Triage to wrong level; and sends to registration delay in triage in reception area Patient registration Delay in registration; wrong registration (wrong patients) The patient waits in Long waiting time, the waiting area unmonitored patients after registration during waiting time Physician triages patient Triage to wrong level; delay in triage process The patient waits in Long waiting time; no the waiting area after workup during physician triage waiting time The patient is admitted Delay in entering vital to adult care or urgent signs into the hospital care units in the ED information system The ED bedside nurse Lack of workup while assesses the patient waiting to be seen; missed (vital signs and entering of vital signs history taking) every 2 hr The ED physician Unable to detect sepsis signs (resident) assesses the patient (history and physical exam) The ED physician Delay in assessment (consultant) assesses patients (history and physical exam) The ED physician enters Delay in ordering laboratory the investigations and test; delay in collecting initial treatment into laboratory sample; delay in the system receiving laboratory result; delay in treating sepsis The ED physician identifies Delay in identifying the admitting service the admitting consultant; delay in acceptance from admitting consultant The junior resident in Wrong assessment by the admitting service the junior physician; delay assesses the patient in assessment by the junior physician The senior resident from Wrong assessment by the admitting service the senior physician; delay assesses the patient in assessment by the senior physician The treating team decides Delay in referral to to refer the patient to the ICU service the critical care team
SN
Process
Failure Modes
2.1 The senior resident from the admitting service refers the patient to ICU resident 2.2 The ICU resident refers the patient to ICU staff physician 2.3 The ICU staff physician refers the patient to ICU consultant 2.4 The ICU consultant assesses the patient and confirms sepsis 2.5 The ICU consultant orders additional workups 3.1 Measuring lactate level 3.2 Obtaining 2 sets of blood cultures before administering antibiotics 3.3 Ordering and administering of IV fluid bolus
3.4 Ordering and administering of broad-spectrum antibiotics 3.5 Physician inserts a central line (if indicated)
The admitting service resident delays the referral to ICU resident The ICU resident delays the referral to ICU staff physician The staff physician delays the referral to ICU consultant Diagnostic error Delayed additional workup
Delay ordering lactate level; delay collecting lactate sample; delay receiving lactate result Failure to obtain and send 2 sets of blood culture
Inappropriate selection of type of fluid bolus; inappropriate volume of fluid bolus; delay in ordering fluid bolus Inappropriate selection of type of antibiotics; delays in ordering, dispensing, and administering antibiotics Delay in inserting central line, failure to insert central line
3.6 Monitoring of CVP and venous saturation
Failure to monitor CVP
3.7 Ordering and administering of vasopressors
Delay in ordering vasopressors, delay in dispensing vasopressors; delay in administering vasopressors Delay in identifying the source of infection; failure to control source of infection
3.8 Identification and control of infection source
CVP indicates central venous pressure; IV, intravenous; SN, serial number of the failure mode.
than other tools that are still being performed, such as root cause analysis on adverse events identified by means of mortality and morbidity reviews and voluntary electronic incident reporting. This report is one of the few published so far on the use of FMEA in clinical settings, but to our knowledge, this is the first study that uses FMEA to outline the vulnerabilities in the care process of septic patients admitted through the ED. In a recent report, Asefzadeh et al24 studied the uses of FMEA in the ICU setting and concluded that using the tool can identify risks that are preventable. Another study in the dialysis unit showed that FMEA can identify critical actions needed to reduce the clinical risk of
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dialysis patients.30 In addition, in the pediatric oncology inpatients setting, health care failure mode and effect analysis (a variant of FMEA) was shown to be a useful method for detecting failure modes, and the patient or the parent can contribute to the process and be part of the team.27 The FMEA was also used successfully in the treatment of trauma patients, where it was reported to help in systematically identifying and prioritizing risks to patient safety from errors of registration.26 In addition, in a recent study on the use of FMEA in the treatment planning of scanned proton beam radiotherapy, the application of FMEA identified strategies for risk mitigation to improve the safety of patients.20 The method © 2014 Lippincott Williams & Wilkins
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FMEA to Improve the Care of Septic Patients
TABLE 5. The 22 High-Risk Failure Modes and Their RPN SN 1.3.a 1.3.b 1.5.a 1.5.b 1.6.b 1.7.a 1.10.a 1.10.c 1.10.d 1.12.b 1.13.a 1.13.b 3.1.a 3.1.c 3.2.a 3.3.b 3.4.b 3.4.c 3.5.a 3.6.a 3.7.b 3.8.a
Failure Mode
Severity
Occurrence
Detection
RPN
Long waiting time Unmonitored patients during waiting time Long waiting time No workup during waiting time Lack of work up while waiting to be seen Missed entering of vital signs every 2 hr Delay in ordering laboratory tests Delay in receiving laboratory results Delay in treating sepsis Delay in assessment by the junior physician Wrong assessment by the senior physician Delay in assessment by the senior physician Delay in ordering serum lactate level Delay in receiving serum lactate result Failure to obtain and send 2 sets of blood culture Inappropriate volume of fluid bolus Delay in ordering antibiotics Delay in dispensing antibiotics Delay in inserting central line Failure to monitor central venous pressure Delay in dispensing vasopressors Delay in identifying source of infection
7 7 7 7 7 7 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9
9 9 9 10 9 7 5 8 6 8 5 8 5 8 8 8 8 8 9 9 8 7
7 7 6 9 9 9 9 8 8 5 9 9 8 8 8 8 8 8 9 8 8 7
441 441 378 630 567 441 405 576 432 360 405 648 360 576 576 576 576 576 729 648 576 441
SN, indicates serial number of the failure mode.
was also recommended and required by the Joint Commission International.31 In the complex process of treating septic patients, the single process with the highest risk for error was the initial workup and treatment of septic patients. Most of the risk for errors in this activity seemed to be related to the delays in ordering essential laboratory tests, collecting laboratory samples, receiving laboratory results, and initiating the sepsis bundle. The mitigation actions adopted in our institution to address these issues were implementing an E-Alert system to identify patients with signs of severe sepsis (systemic inflammatory response syndrome plus 1 organ failure indicator) and designing an order set in the CPOE that contains all the elements of the sepsis bundle,1 which could be activated by the treating physicians via a single click. Therefore, system-initiated alerts, simplification, and standardization were adapted as shown by the literature to improve the reliability of the care process.32 The validity of FMEA as a tool used in health care setting has been questioned in the literature recently, especially its content and criterion validity.33 Although we acknowledge that FMEA proved to be a useful tool in aiding our multidisciplinary team to map and better understand the process of care of septic patients admitted through the ED, and with the aim of improving patient safety, we used other methodologies such as electronic incident reporting, analysis, and trending of these reports to prioritize improvement efforts.34 We use the FMEA as part of a quality improvement project, to prioritize areas in the process of care of septic patients admitted through the ED. Using this analysis, one of the recommendations of the study was to improve recognition of sepsis, so an E-Alert system was designed to alert health care providers once patients’ vital signs or laboratory work suggests sepsis. That improved substantially the diagnosis of sepsis and severe sepsis before the patient © 2014 Lippincott Williams & Wilkins
developed septic shock. The second large category was sepsis resuscitation, and as such, we developed a sepsis response team to address the challenges identified by FMEA. This study has some limitations. As a single-institution study, the findings reflect the care delivery model at the ICU and ED, and although many features are common to other health care TABLE 6. Selected Corrective Actions and the Phases Targeted in Sepsis Management Corrective Action
Targeted Phase
Increase awareness through educational sessions Standardization of sepsis management Central line guidelines Standardize training on central line insertion Vasopressor use guidelines Clinical pathway for management of sepsis Improve communication Weekly electronic mobile text message to all physicians, reporting compliance rates with sepsis bundle Standardize the hand over process for the sepsis team Improve access to care Establishing a sepsis team Creating a sepsis bed in the ICU Using information technology Creating an E-Alert for detecting septic patient Standardizing a sepsis bundle activated by 1 click in the CPOE system
Phase 1, 2, 3 Phase 1, 2, 3 Phase 3 Phase 3 Phase 3 Phase 1, 2, 3 Phase 1, 2, 3 Phase 1, 2, 3 Phase 2 Phase 2, 3 Phase 2 Phase 3 Phase 1, 2, 3 Phase 1 Phase 2, 3
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organizations, others reflect local procedures, resources, and norms. For these reasons, the results might not be completely generalizable to other organizations. Moreover, FMEA identifies higher risk for failure modes through calculating RPN, and in our experience and what was reported in the literature, the estimation of occurrence and detectability is highly dependent on the team member’s experience and judgment. Therefore, it is important to create a multidisciplinary team of frontline health care professionals who know perfectly the process that can improve the consistency of FMEA.
CONCLUSIONS In the current health care environment, patient safety and care reliability are a major concern, especially in the high-risk population such as septic patients. The presented data suggest that tools such as FMEA can enable a detailed analysis of the complex care process of septic patients, to outline potential failure modes and highlight which risks have the greatest concern, thus guiding improvement efforts to focus on high-leverage processes. REFERENCES 1. Dellinger RP, Levy MM, Rhodes A, et al. Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock: 2012. Crit Care Med. 2013;41:580–637. 2. Na S, Kuan WS, Mahadevan M, et al. Implementation of early goal-directed therapy and the surviving sepsis campaign resuscitation bundle in Asia. Int J Qual Health Care. 2012;24:452–462. 3. Vincent J-L, Sakr Y, Sprung CL, et al. Sepsis in European intensive care units: results of the SOAP study. Crit Care Med. 2006;34:344–353. 4. Wang HE, Devereaux RS, Yealy DM, et al. National variation in United States sepsis mortality: a descriptive study. Int J Health Geogr. 2010;9:9. 5. Rivers E, Nguyen B, Havstad S, et al. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001;345: 1368–1377. 6. Dellinger RP, Carlet JM, Masur H, et al. Surviving Sepsis Campaign guidelines for management of severe sepsis and septic shock. Crit Care Med. 2004;32:858–873. 7. Levy MM, Pronovost PJ, Dellinger RP, et al. Sepsis change bundles: converting guidelines into meaningful change in behavior and clinical outcome. Crit Care Med. 2004;32(suppl 11):S595–S597. 8. Levy MM, Dellinger RP, Townsend SR, et al. The Surviving Sepsis Campaign: results of an international guideline-based performance improvement program targeting severe sepsis. Crit Care Med. 2010;38:367–374. 9. Phua J, Koh Y, Du B, et al. Management of severe sepsis in patients admitted to Asian intensive care units: prospective cohort study. BMJ. 2011;342:d3245. 10. International JCRJC. Failure Mode and Effects Analysis in Health Care: Proactive Risk Reduction. 3rd ed. Terrace, IL: Joint Commission Resources, 2010. 11. DeRosier J, Stalhandske E, Bagian J, et al. Using Health Care Failure Mode and Effect Analysis™: The VA National Center for Patient Safety’s Prospective Risk Analysis System. Jt Comm J Qual Improv. 2002;27:248–267. 12. Thornton E, Brook OR, Mendiratta-Lala M, et al. Application of failure mode and effect analysis in a radiology department. Radiographics. 2011;31:281–293. 13. Lago P, Bizzarri G, Scalzotto F, et al. Use of FMEA analysis to reduce risk of errors in prescribing and administering drugs in paediatric wards: a quality improvement report. BMJ Open. 2012;2:1–10.
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