Root Cause Analysis literature review

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The following literature on Root Cause Analysis for clinical settings was compiled by the Brian Tutt Library and Resource Centre, NSW Department of Health, North Sydney.

About RCAs and how to conduct them

Victorian Government Department of Human Services. Sentinel Events
Western Australian Office of Quality and Safety in Health Care. Sentinel Events
South Australia Department of Health. Safety and Quality. Root Cause Analysis
Royal Children's Hospital, Melbourne. Clinical Risk Management
Veterans Affairs National Center for Patient Safety. Root Cause Analysis (RCA)
Consequence. Root Cause Analysis. Consequence is one of the UK's leading independent risk management consultants to the healthcare sector.

Articles

NetCE Continuing education. Medical Error Prevention and Root Cause Analysis

Woloshynowych M, Rogers S, Taylor-Adams S, Vincent C. The investigation and analysis of critical incidents and adverse events in healthcare. Health Technol Assess. 2005 May;9(19):1-158.

>more: Objectives were to carry out a review of published and unpublished work on the analysis on methods of accident investigation in high-risk industries, and of critical incidents in healthcare. To develop and pilot guidelines for the analysis of critical incidents in healthcare for the hospital sector, mental health and primary care.

SOA Associates. Root Cause Analysis of Medical Errors and Sentinel Events

>Abstract: After extensive review of the literature and analysis of the six dimensions of quality (safety, effectiveness, efficiency, timeliness, patient-centeredness, and equity) in the Institute of Medicine report, "Crossing the Quality Chasm", we conducted sentinel event analysis using medical/clinical errors data for 78,364 hospitals and nursing homes. In particular, we analyzed independent predictors of re-hospitalization, procedure complications, wrong-site surgery, treatment delay and restraint death. Risk factors used included blood type mismatch ("A" and "O"), mis-spelling of names, control of medications (storage/access, labeling of medications), supervision of staff, adequacy of technological support, staffing levels, patient identification process, patient observation procedures, care planning process credentialing, orientation and training of staff, competency assessment, physical environment, communication among staff members, physical assessment process, behavioral assessment process, communication with patient/family.

Iedema RA, Jorm C, Long D, Braithwaite J, Travaglia J, Westbrook M. Turning the medical gaze in upon itself: root cause analysis and the investigation of clinical error. Soc Sci Med. 2006 Apr;62(7):1605-15. Epub 2005 Oct 6.

>Abstract: In this paper, we discuss how a technique borrowed from defense and manufacturing is being deployed in hospitals across the industrialized world to investigate clinical errors. We open with a discussion of the levers used by policy makers to mandate that clinicians not just report errors, but also gather to investigate those errors using root cause analysis (RCA). We focus on the tensions created for clinicians as they are expected to formulate 'systems solutions' that go beyond blame.
In addressing these matters, we present a discourse analysis of data derived during an evaluation of the NSW Health Safety Improvement Program. Data include transcripts of RCA meetings which were recorded in a local metropolitan teaching hospital. From this analysis we move back to the argument that RCA involves clinicians in 'immaterial labour', or the production of communication and information, and that this new labour realizes two important developments. First, because RCA is anchored in the principle of health care practitioners not just scrutinizing each other, but scrutinizing each others' errors, RCA is a challenging task. Second, thanks to turning the clinical gaze in on the clinical observer, RCA engenders a new level of reflexivity of clinical self and of clinical practice. We conclude with asking whether this reflexivity will lock the clinical gaze into a micro-sociology of error, or whether it will enable this gaze to influence matters superordinate to the specifics of practice and the design of clinical treatments; that is, the over-arching governance and structuring of hospital care.

O'Connor N. Ward D. Newton L. Warby M. Enabling clinicians to become the quality leaders in a mental health service. Australasian Psychiatry. 13(4):357-61, 2005 Dec.

>more: Objective:To show how clinicians can become the leaders of 'quality' in a mental health services, using the example of developments within Northern Sydney Health (NSH) Area Mental Health Services (AMHS).
Method: In the absence of an existing integrated area quality programme, NSH AMHS implemented a quality improvement programme whereby staff at the coalface would become the leaders in 'quality' guided and supported by the newly established Quality Unit. This innovative approach is consistent with evidence that suggests that clinicians need to 'own' quality improvement initiatives and embed them into everyday practice, rather than see them as the role of a designated 'quality' person/s.
Results: Within 12 months the service trained over 100 clinicians in Clinical Practice Improvement (CPI) methodology and currently has over 20 CPI projects with an identified measurable outcome. As well, it has provided over 200 staff with in-services on quality improvement approaches and trained 45 staff in root cause analysis. Training of eight clinicians in the use of the Minitab statistical package has allowed data analysis and charting to identify opportunities for improvement.
Conculsion: The handing of 'quality' back to clinicians of the AMHS has provided a framework for improved outcomes for patients and carers. This approach to service improvement is transferable to other mental health services.

Wolf MS. Bennett CL. Local perspective of the impact of the HIPAA privacy rule on research. Cancer. 106(2):474-9, 2006 Jan 15.

>more: Background:The operational and economic impact of the Health Insurance Portability and Accountability Act (HIPAA) of 1996 was evaluated. The setting was a natural experiment which involved a single-site, clinical research study that was initiated before the enactment of HIPAA and subsequently modified to be compliant with the new policy.
Method: A formative assessment was conducted of the recruitment process to a clinical trial evaluating the efficacy of an educational strategy to inform Veterans about the National Cancer Institute/Department of Veterans Affairs cosponsored Selenium and Vitamin E Cancer Prevention Trial (SELECT). Personnel time and costs were determined based on weekly accrual for study periods before and after the implementation of HIPAA. Root cause analysis was used to assess the recruitment protocol and to identify areas for improvement.
Results:The implementation of HIPAA resulted in a 72.9% decrease in patient accrual (7.0 patients/wk vs. 1.9 patients/wk, P < 0.001), and a threefold increase in mean personnel time spent recruiting (4.1 hrs/patient vs. 14.1 hrs/patient, P < 0.001) and mean recruitment costs (49 US dollars/patient vs. 169 US dollars/patient, P < 0.001). Upon review of the modified HIPAA-compliant protocol, revisions in the recruitment procedure were adopted. The revised protocol improved weekly accrual by 73% (1.9 patients/wk vs. 7.1 patients/wk, P < 0.001) and resulted in improvements in personnel time (5.4 hrs/patient) and recruitment costs (65 US dollars/patient).
Conclusion Enactment of HIPAA initially placed a considerable burden on research time and costs. Establishing HIPAA-compliant recruitment policies can overcome some of these obstacles, although recruitment costs and time are likely to be greater than those observed before HIPAA.

Woodward S. Learning and sharing safety lessons to improve patient care. Nursing Standard. 20(18):49-53, 2006 Jan 11-17.

>more: Nurses are at the forefront of patient safety and are constantly reviewing their practice to improve care delivery. When things go wrong in health care the consequences can be distressing for patients and staff. Lessons need to be learned and acted on to minimise the likelihood of reoccurrence. The 'root cause analysis' approach provides nurses and other healthcare staff with a consistent and structured methodology to investigate incidents. It enables staff to identify where systems are failing and where improvements in patient care and safety can be made.

Tsuchiya H. Kurosaki H. Hiramoto S. Seki M. Moriuchi K. Kawauchi S. Kurita I. Analysis of medical accidents using the "Why Why Why Analysis" (questions): comparison with conventional analytical techniques. Nippon Hoshasen Gijutsu Gakkai Zasshi. 61(12):1638-44, 2005 Dec 20.

>more: Techniques such as 4M-4E matrices and the SHEL model have been proposed in recent years as tools for analyzing medical accidents and developing countermeasures. There have been hardly any reports, however, describing their use for the development of risk strategies in the medical setting. After using the SHEL model, Toranomon Hospital is currently using "Why Why Why Analysis" and has had several successes as a result of its use. With this in mind, a comparative study was conducted between "Why Why Why Analysis" and several previously reported accident countermeasure tools, root cause analysis (RCA), used at Veterans Hospitals in the US, and quality control (QC), used in the industrial sector. As a result, "Why Why Why Analysis" as applied in radiology work was determined to be easy to deploy even for beginners as compared with the other tools, able to accommodate complaints as well as accidents, and useful on the basis of having both practical and expandable functions for improving radiology work.

Ryan CA. Mohammad I. Murphy B. Normal neurologic and developmental outcome after an accidental intravenous infusion of expressed breast milk in a neonate. Pediatrics. 117(1):236-8, 2006 Jan.

>more: Here we describe a premature male infant who was accidentally given 10 mL of expressed breast milk intravenously over a 3.5-hour period. Having survived this event with supportive care, this boy was attending regular school with no obvious neurologic or learning difficulties at 6 years of age. In 1998, after a query on an e-mail discussion group for health care providers in neonatology (NICU-net), we were informed of 8 similar events that proved fatal in 3 infants. A root-cause analysis revealed that accidental intravenous administration of breast milk or formula can be avoided by the use of color-coded enteral-administration sets with Luer connections that are not compatible with intravenous cannulas. The addition of methylene blue to feeds, or bolus enteral feeds (instead of continuous gastric feedings), may also help prevent such errors. These cases show the value of gathering information about rare but important events through a neonatal network. In addition, they confirm that prevention of medical error should focus on faulty systems rather than faulty people.

Roumm AR. Sciamanna CN. Nash DB. Health care provider use of private sector internal error-reporting systems. American Journal of Medical Quality. 20(6):304-12, 2005 Nov-Dec.

>more: The purpose of this study was to review the state of the art of private sector internal error-reporting systems and to begin to develop a classification system for comparing systems. Interviews were conducted to research and examine 9 systems currently on the market. Analysis resulted in the following observations: (1) 7 of the systems are stand-alone, while 2 are part of larger hospital information systems; (2) most of the systems have been in existence for less than 5 years; (3) acute care hospitals are the primary clients; (4) systems are capable of interfacing with other information systems and root-cause analysis programs; and (5) systems are browser based and accessible via the Internet and/or the provider's intranet. Additional studies are needed to determine the impact of these systems on health outcomes. However, one fact is clear: tracking incidents will not improve patient safety unless administrators close the feedback loop on quality.

Raab SS. Grzybicki DM. Zarbo RJ. Meier FA. Geyer SJ. Jensen C. Anatomic pathology databases and patient safety. Archives of Pathology & Laboratory Medicine. 129(10):1246-51, 2005 Oct.

>more: Context: The utility of anatomic pathology discrepancies has not been rigorously studied. OBJECTIVE: To outline how databases may be used to study anatomic pathology patient safety.
Design: The Agency for Healthcare Research and Quality funded the creation of a national anatomic pathology errors database to establish benchmarks for error frequency. The database is used to track more frequent errors and errors that result in more serious harm, in order to design quality improvement interventions intended to reduce these types of errors. In the first year of funding, 4 institutions (University of Pittsburgh, Henry Ford Hospital, University of Iowa, and Western Pennsylvania Hospital) reported cytologic-histologic correlation error data after standardizing correlation methods. Root cause analysis was performed to determine sources of error, and error reduction plans were implemented.
Participants: Four institutions self-reported anatomic pathology error data.
Main Outcome Measures: Frequency of cytologic-histologic correlation error, case type, cause of error (sampling or interpretation), and effect of error on patient outcome (ie, no harm, near miss, and harm).
Results: The institutional gynecologic cytologic-histologic correlation error frequency ranged from 0.17% to 0.63%, using the denominator of all Papanicolaou tests. Based on the nongynecologic cytologic-histologic correlation data, the specimen sites with the highest discrepancy frequency (by project site) were lung (ranging from 16.5% to 62.3% of all errors) and urinary bladder (ranging from 4.4% to 25.0%). Most errors detected by the gynecologic cytologic-histologic correlation process were no-harm events (ranging from 10.7% to 43.2% by project site). Root cause analysis identified sources of error on both the clinical and pathology sides of the process, and error intervention programs are currently being implemented to improve patient safety. CONCLUSIONS: A multi-institutional anatomic pathology error database may be used to benchmark practices and target specific high-frequency errors or errors with high clinical impact. These error reduction programs have national import.

Healey F. Root cause analysis for tissue viability incidents. Journal of Tissue Viability. 16(1):12-5, 2006 Feb.
[no abstract]

Raab SS. Improving patient safety by examining pathology errors. [Review] [87 refs] Clinics in Laboratory Medicine. 24(4):849-63, 2004 Dec.

>more: A considerable void exists in the information available regarding anatomic pathology diagnostic errors and their impact on clinical outcomes. To fill this void and improve patient safety, four institutional pathology departments (University of Pittsburgh, Western Pennsylvania Hospital, University of Iowa Hospitals and Clinics, and Henry Ford Hospital System) have proposed the development of a voluntary, Web-based, multi-institutional database for the collection and analysis of diagnostic errors. These institutions intend to use these data proactively to implement internal changes in pathology practice and to measure the effect of such changes on errors and clinical outcomes. They believe that the successful implementation of this project will result in the study of other types of diagnostic pathology error and the expansion to national participation. The project will involve the collection of multi-institutional anatomic pathology diagnostic errors in a large database that will facilitate a more detailed analysis of these errors, including their effect on patient outcomes. Participating institutions will perform root cause analysis for diagnostic errors and plan and execute appropriate process changes aimed at error reduction. The success of these interventions will be tracked through analysis of postintervention error data collected in the database. Based on their preliminary studies, these institutions proposed the following specific aims: Specific aim #1: To use a Web-based database to collect diagnostic errors detected by cytologic histologic correlation and by second-pathologist review of conference cases. Specific aim #2: To analyze the collected error data quantitatively and generate quality performance reports that are useful for institutional quality improvement programs. Specific aim #3: To plan and implement interventions to reduce errors and improve clinical outcomes, based on information derived from root cause analysis of diagnostic errors. Specific aim #4: To assess the success of implemented interventions by quantitative measure of postinterventional errors and clinical outcomes and by qualitative assessment by project participants. Funding for this project was approved by the Agency for Health Care Research and Quality in September 2002, and data collection and analysis are ongoing. Over 5000 errors have been collected in the database, and the clinical outcomes of these errors have been tracked. At a national meeting in November 2003, root cause analysis was performed to determine causes of errors. The findings of these root cause analyses have been presented at national pathology meetings and are currently being published. [References: 87]

Woodward S. Learning and sharing safety lessons to improve patient care. Nursing Standard. 20(18):49-53, 2006 Jan 11-17.

>more: Nurses are at the forefront of patient safety and are constantly reviewing their practice to improve care delivery. When things go wrong in health care the consequences can be distressing for patients and staff. Lessons need to be learned and acted on to minimise the likelihood of reoccurrence. The 'root cause analysis' approach provides nurses and other healthcare staff with a consistent and structured methodology to investigate incidents. It enables staff to identify where systems are failing and where improvements in patient care and safety can be made.

Savage SW. Schneider PJ. Pedersen CA. Utility of an online medication-error-reporting system. American Journal of Health-System Pharmacy. 62(21):2265-70, 2005 Nov 1.

>more: The utility of an online medication-error-reporting program was evaluated. METHODS: A survey regarding the utility of Medmarx was developed and mailed to 550 hospitals and health systems that used the medication-error-reporting program. Primary contact persons were identified and asked to gather and report the necessary information to adequately characterize medication-error reporting in their institution before and after implementing the Medmarx system. Potential respondents were contacted four times during the survey period by the United States Pharmacopeia. RESULTS: Of the 550 surveys sent, 200 were returned and 25 were undeliverable, resulting in a response rate of 38%. The average number of medication errors reported internally increased twofold after the adoption of the Medmarx system. Pharmacy departments were most often reported as responsible for medication-safety oversight activities after Medmarx implementation. Most facilities (94%) generated reports from the medication-error database, and 75% used this information to identify 7.0+/-8.1 opportunities to improve their medication-use system annually. Most respondents believed that Medmarx played an integral role in preparing their facility for Joint Commission accreditation surveys (65%), provided a tool for root-cause analysis (71%), and helped identify problems in the medication-use process (85%). The annual costs of the subscription and staff time required to use the system was estimated to be 16,756 dollars+/-21,108 dollars. Sixty-six percent of users were satisfied with the impact the system has had on improving the medication-use process. CONCLUSION: Implementation of the Medmarx system led to an increase in the number of reported medication errors and improvements in the medication-use process.

Middleton S. Walker C. Chester R. Implementing root cause analysis in an area health service: views of the participants. Australian Health Review. 29(4):422-8, 2005 Nov.

>more: Purpose: This study identifies the attitudes of participants in the root cause analysis (RCA) process and barriers to it's implementation within one New South Wales area health service.
Method: Employees and consumer representatives of the former South Western Sydney Area Health Service who participated in an RCA as either a team member or a team leader between December 2002 and October 2003 completed a self-administered survey.
Results: Thirty seven of 39 eligible participants completed the survey (response rate 95%). The respondents identified formulation of causal statements, ensuring the causal statements met the "rules of causality" outlined by New South Wales Health, and arranging times for interviews as most difficult. Team leader respondents (n = 7) ranked keeping the team focused, organising the first meeting within 7 days of the incident, and completing the RCA in three 2-hour meetings as barriers to the process. CONCLUSIONS: Training was valued by participants, however greater emphasis on the development of causal statements could be beneficial. Team leaders expressed difficulty in keeping the team focused and meeting the stipulated RCA timeframes, suggesting that additional support for RCA participants may be warranted.

Spigelman AD. Swan J. Review of the Australian incident monitoring system. ANZ Journal of Surgery. 75(8):657-61, 2005 Aug.

>more: Background: A survey was conducted to assess the benefits and limitations of the Australian Incident Monitoring System (AIMS) as a programme to improve patient safety.
Methods: A 12-point questionnaire was sent to 12 current users of AIMS in November 2002.
Results: The AIMS provides a consistent system of coding, trending and monitoring of incident data. It promotes a patient safety culture and an awareness of system error. Other benefits include the building of teamwork and the implementation of strategies to reduce the prevalence and severity of incidents. The majority of respondents (83%) reported that AIMS investigations resulted in significant changes to equipment usage, medication prescribing or administration, clinical protocols, training programmes and falls risk assessment tools. Although 75% of users reported improvements in patient outcomes, these were difficult to measure. A major limitation of AIMS was the low rate of incident reporting by medical staff. Voluntary reporting systems did not capture all incident data and the information was often too generic for root cause analysis. There were difficulties benchmarking data and concerns were raised regarding the ownership of information. The programme requires ongoing resources to implement change strategies and to maintain incident reporting levels. On a scale of 1 (poor rating) to 10 (excellent rating) the mean benefit rating was 7.6. CONCLUSION: The Australian Incident Monitoring System is beneficial as a component of a clinical risk management strategy. Usefulness could be improved by increased participation by medical staff. The level of resources required should not be underestimated if the programme is to demonstrate improvements to patient outcomes. More recent versions of AIMS promise improved capabilities and will require similar evaluation.

Perkins JD. Levy AE. Duncan JB. Carithers RL Jr. Using root cause analysis to improve survival in a liver transplant program. Journal of Surgical Research. 129(1):6-16, 2005 Nov.

>more: Background: With the advent of programs such as the American College of Surgeons-National Surgical Quality Improvement Program, surgical services will be compared with their peers across the United States. At times, many programs will experience lower-than-expected outcomes. During July 1, 1998, to June 30, 2000 our 1-year graft (76.86%, P = 0.23) and patient (80.61%, P = 0.016) survivals after liver transplantation were lower than our expected rates (graft 81.89% and patient 88.3%), according to the U.S. Scientific Registry of Transplant Recipients (SRTR).
Methods: We used aggregate root cause analysis to determine underlying reasons for our patient deaths. Two of our surgeons performed a systematic review of all our center's liver transplant patient deaths from January 1, 1995, to December 31, 2000. Each phase of the transplant process was reviewed. RESULTS: Of 355 patients receiving their first transplant, there were 90 deaths, with 188 root causes identified. The apportionment according to phase of the transplant process was patient selection, 50%; transplant procedure, 17%; donor selection, 15%; post-transplant care, 8%, and psychosocial issues, 10%. Risk reduction action plans were developed, and several important changes made in our care protocol. In April 2004, SRTR data revealed that for patients transplanted between January 1, 2001 and June 30, 2003, our 1-year liver graft survival of 90.73% (P = 0.018) was significantly higher than the national expected rate of 84.48%. Our 1-year patient survival rate of 92.66% (P = 0.285) was higher than the expected rate of 89.29%.
Conculsions: Lower-than-expected outcomes can provide an impetus for improving patient care and raising the quality of a surgical service. Aggregate root cause analysis of adverse events is a valuable method for program improvement.

McDonald A. Leyhane T. Drill down with root cause analysis. [Review] [8 refs] Nursing Management. 36(10):26-31; quiz 31-2, 2005 Oct.

>more: Review the structure of an effective critical event analysis and suggestions for completing documentation and maximizing knowledge while protecting your organization from litigation. [References: 8]

Bagian JP. Patient safety: what is really at issue? Frontiers of Health Services Management. 22(1):3-16, 2005.

>more: The Veterans Health Administration found that a number of components were key to implementing a meaningful and effective patient safety program. To truly improve patient safety, the overall goal of your organization must be to prevent harm to the patient, not to eliminate errors. Create a system that is perceived as fair, and mitigate perceived barriers to improving patient safety. Create a transparent system for prioritizing and establishing how resources will be applied to the patient safety effort. Provide tools that support root cause analysis that moves beyond superficial and inadequate questions such as, Whose fault is this? Action that results in improvement, not simply analysis of the problem, is needed. Finally, leadership and management must be visibly involved in the patient safety program.

Anonymous. Universal protocol cuts hip surgery fatalities. Healthcare Benchmarks & Quality Improvement. 12(3):30-1, 2005 Mar.

>more: Root-cause analysis employed to determine best way to proceed. Medical management department takes lead role in developing new protocol. New privileging requirements established for those conducting pre-op assessments.

Piotrowski MM. Bessette RL. Chensue S. Cutler D. Kachalia A. Roseborough JW. Saint S. Underwood W 3rd. Murphy HS. Learning to improve safety: false-positive pathology report results in wrongful surgery [large PDF] Joint Commission Journal on Quality & Patient Safety. 31(3):123-31, 2005 Mar.

>more: Background: A patient experienced a wrongful surgical resection, specifically, a radical retropubic prostatectomy because of a false-positive pathology report. FINDINGS FROM THE ROOT CAUSE ANALYSIS (RCA): The RCA team identified three antecedent events that contributed to this medical error: (1) a second (concurring) pathologist did not provide a written opinion, (2) a single pathologist who reviewed and signed the final report, and (3) a pathologist who did not review the case and reconfirm the diagnosis immediately prior to the surgical resection. RECOMMENDATIONS: The RCA team recommended that the concurring pathologist write his or her diagnostic findings on the referral form, two pathologists review and sign the final typed report, and a pathologist rereview the slides on the business day prior to a surgical resection. Because the prostate specific antigen (PSA) value can be helpful in select cases of prostate cancer, the team recommended the PSA value be referenced when reviewing prostate specimens obtained through fine-needle biopsy. TRACKING COMPLIANCE: Because a wrongful surgical resection is a rare event, emphasis was placed on measuring compliance with distinct elements that were part of the revised procedure. During a 12-month span, practitioners demonstrated sustained compliance to the enhanced process for analyzing and reporting results.

Fernando M. An analysis of clinical risks in vaccine transportation. British Journal of Community Nursing. 9(10):411-5, 2004 Oct.

>more: 'Cold chain' transport is an integral part of a system of vaccine transportation that assures the potency of vaccines. If the temperature of vaccines is not kept between the ranges of 2 and 8 degrees C, this can lead to adverse effects especially for the recipients of first time immunization, as no protection is offered. This investigation has shown that there is considerable risk of vaccines being rendered impotent due to ad hoc collection of vaccines by healthcare professionals from pharmacy services, outside of the cold chain transport agreement with the vaccine supplier. This is because at present there are no guidelines for ad hoc collection of either vaccines or the approved cold chain equipment provided to transport the vaccine. The root cause analysis has shown that the general practice can manage this risk by making changes to its system for vaccine ordering, stock control and maintenance. A number of changes are proposed, including the appointment of a vaccine coordinator and the development of a protocol for ad hoc collection of vaccines from pharmacy. By focusing on improving the quality of the process, the practice can improve the care and safety of its immunization programme.

Carayon P. Schultz K. Hundt AS. Righting wrong site surgery. Joint Commission Journal on Quality & Safety. 30(7):405-10, 2004 Jul.

>more: Background: As defined by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), wrong site surgery includes wrong side or siteof the body, wrong procedure, and wrong-patient surgeries. Although many health care organizations are implementing guidelines and procedures to decrease the occurrence of wrong site surgery, numerous barriers to their effectiveness have been identified.
Human Factors Engineering (HFF) Analysis: A human factors system analysis can be used to better understand how elements of a work system combine andinteract to contribute to breakdowns in the system. A case study of wrong site surgery in an outpatient setting illustrates how the different work systtem elements can contribute to the occurrence of a wrong site surgery. In analyzing the care process, it is particularly important to identify the transitions of care, which can be sources of patient safety problems when deficits in communication and information transfer occur (for example, miscommunication, information not transmitted on time, wrong information transmitted, misunderstanding of the information transmitted).
Recommendations: After a wrong site surgery, conduct a root cause analysis that uses the work system model and includes a surgery care process analysis similar to the one described in the case study; collaborate with human factors engineers to learn how to apply the work system model; apply the work system model to process analysis; and optimize work systems.

Weingart SN. Tess A. Driver J. Aronson MD. Sands K. Creating a quality improvement elective for medical house officers [PDF] Journal of General Internal Medicine.

>more: The Accreditation Council on Graduate Medical Education (ACGME) requires that house officers demonstrate competencies in "practice-based learning and improvement" and in "the ability to effectively call on system resources to provide care that is of optimum value." Anticipating this requirement, faculty at a Boston teaching hospital developed a 3-week elective for medical house officers in quality improvement (QI). The objectives of the elective were to enhance residents' understanding of QI concepts, their familiarity with the hospital's QI infrastructure, and to gain practical experience with root-cause analysis and QI initiatives. Learners participated in three didactic seminars, joined hospital-based QI activities, conducted a root-cause analysis, and completed a QI project under the guidance of a faculty mentor. The elective enrolled 26 residents in 3 years. Sixty-three percent of resident respondents said that the elective increased their understanding of QI in health care; 88% better understood QI in their own institution.

Plews-Ogan ML. Nadkarni MM. Forren S. Leon D. White D. Marineau D. Schorling JB. Schectman JM. Patient safety in the ambulatory setting. A clinician-based approach [PDF] Journal of General Internal Medicine. 19(7):719-25, 2004 Jul.

>more: Background: Voluntary reporting of near misses/adverse events is an important but underutilized source of information on errors in medicine. To date, there is very little information on errors in the ambulatory setting and physicians have not traditionally participated actively in their reporting or analysis.
Objectives: To determine the feasibility and effectiveness of clinician-based near miss/adverse event voluntary reporting coupled with systems analysis and redesign as a model for continuous quality improvement in the ambulatory setting.
Design: We report the initial 1-year experience of voluntary reporting by clinicians in the ambulatory setting, coupled with root cause analysis and system redesign by a patient safety committee made up of clinicians from the practice.
Settings: Internal medicine practice site of a large teaching hospital with 25,000 visits per year.
Measurements and main results: There were 100 reports in the 1-year period, increased from 5 in the previous year. Faculty physicians reported 44% of the events versus 22% by residents, 31% by nurses, and 3% by managers. Eighty-three percent were near misses and 17% were adverse events. Errors involved medication (47%), lab or x-rays (22%), office administration (21%), and communication (10%) processes. Seventy-two interventions were recommended with 75% implemented during the study period.
Conculsion: This model of clinician-based voluntary reporting, systems analysis, and redesign was effective in increasing error reporting, particularly among physicians, and in promoting system changes to improve care and prevent errors. This process can be a powerful tool for incorporating error reporting and analysis into the culture of medicine.

Goel A. MacLean CD. Walrath D. Rubin A. Huston D. Jones MC. Niquette T. Kennedy AG. Beardall RW. Littenberg B. Adapting root cause analysis to chronic medical conditions. Joint Commission Journal on Quality & Safety. 30(4):175-86, 2004 Apr.

>more: Background:Root cause analysis (RCA), used to study the conditions leading to acute accidents, was adapted to analyze adverse events in chronic medical conditions.
Methods: RCA was modified to investigate "trigger events"--markers of potential adverse events--in outpatient diabetes care. For 20 cases with the trigger event of hypoglycemia evidenced by an A1C of > or = 11%, a multidisciplinary team reviewed the findings of medical record abstractions, provider interviews, and patient interviews for each case. The RCA team identified active failures, error-producing conditions, latent conditions, and defenses leading to the trigger event in each case.
Results: The methodology identified potential root causes of persistent hyperglycemia. Latent conditions, error-producing conditions, and active failures occurred at the assessment, planning, and implementation phases of a diabetes visit. Recurring failure modes were identified within and across cases.
Conculsion: RCA can be used to study trigger events in medical care for chronic conditions. Although the data collection occurs months after the event, this methodology can identify variations in chronic care and stimulate discussion about potential solutions.

Woodward S. Achieving a safer health service: Part 3. Investigating root causes and formulating solutions. [Review] [18 2004 Mar.

>more: The third paper in our series describes the National Patient Safety Agency's approach to investigation, root-cause analysis and significant event audit. When should an investigation be high level and when should it be low level? What does this mean, and how can lessons be translated into safety solutions in local areas? Central initiatives such as patient-safety alerts are also examined. [References: 18]

Nau DP. Garber MC. Lipowski EE. Stevenson JG. Association between hospital size and quality improvement for pharmaceutical services. American Journal of Health-System Pharmacy. 61(2):184-9, 2004 Jan 15.

>more: Purpose: The relationship between hospital size and quality improvement (QI) for pharmaceutical services was studied.
Methods: A questionnaire on QI was sent to hospital pharmacy directors in Michigan and Florida in 2002. The questionnaire included items on QI lead-team composition, QI tools, QI training, and QI culture.
Results: Usable responses were received from 162 (57%) of 282 pharmacy directors. Pharmacy QI lead teams were present in 57% of institutions, with larger teams in large hospitals (> or = 300 patients). Only two QI tools were used by a majority of hospitals: root-cause analysis (62%) and flow charts (66%). Small hospitals (< 50 patients) were less likely than medium-sized hospitals (50-299 patients) and large hospitals to use several QI tools, including control charts, cause-and-effect diagrams, root-cause analysis, flow charts, and histograms. Large hospitals were more likely than small and medium-sized hospitals to use root-cause analysis and control charts. There was no relationship between hospital size and the frequency with which physician or patient satisfaction with pharmaceutical services was measured. There were no differences in QI training or QI culture across hospital size categories.
Conclusion: A survey suggested that a majority of hospital pharmacies in Michigan and Florida have begun to adopt QI techniques but that most are not using rigorous QI tools. Pharmacies in large hospitals had more QI lead-team members and were more likely to use certain QI tools, but there was no relationship between hospital size and satisfaction measurements, QI training, or QI culture.

Revere L. Black K. Integrating Six Sigma with total quality management: a case example for measuring medication errors. Journal of Healthcare Management. 48(6):377-91; discussion 392, 2003 Nov-Dec.

>more: Six Sigma is a new management philosophy that seeks a nonexistent error rate. It is ripe for healthcare because many healthcare processes require a near-zero tolerance for mistakes. For most organizations, establishing a Six Sigma program requires significant resources and produces considerable stress. However, in healthcare, management can piggyback Six Sigma onto current total quality management (TQM) efforts so that minimal disruption occurs in the organization. Six Sigma is an extension of the Failure Mode and Effects Analysis that is required by JCAHO; it can easily be integrated into existing quality management efforts. Integrating Six Sigma into the existing TQM program facilitates process improvement through detailed data analysis. A drilled-down approach to root-cause analysis greatly enhances the existing TQM approach. Using the Six Sigma metrics, internal project comparisons facilitate resource allocation while external project comparisons allow for benchmarking. Thus, the application of Six Sigma makes TQM efforts more successful. This article presents a framework for including Six Sigma in an organization's TQM plan while providing a concrete example using medication errors. Using the process defined in this article, healthcare executives can integrate Six Sigma into all of their TQM projects.

Kaplan HS. Fastman BR. Organization of event reporting data for sense making and system improvement. Quality & Safety in Health Care. 12 Suppl 2:ii68-72, 2003 Dec.

>more: Feedback and demonstrable local usefulness are critical determinants for adopting event reporting by an organization. The classification schemes used by an organization determine whether an event is recognized or ignored. Near miss events, by their frequency and information content concerning recovery, merit recognition. "Just" cultures are learning cultures that provide a safe haven in which errors may be reported without the fear of disciplinary action in events without reckless behavior. As event report databases grow, selection and prioritization for in depth investigation become critical issues. Risk assessment tools and similarity matching approaches such as in case based reasoning are useful in this regard. Root cause analysis provides a framework for the collection, analysis, and trending of event data. The importance of both internal and external risk communication as valuable reporting system components may be overlooked.

Anonymous. Collaborative patient safety program launched. Healthcare Benchmarks & Quality Improvement. 10(11):130-2, 2003 Nov.

>more: Root-cause analysis of adverse events and near misses are emphasized. Participant make-up offers opportunity to hear differing viewpoints. VA Center for Patient Safety considered a leader in safety movement.

Munger MA. Carter O. Epidemiology and practice patterns of acute decompensated heart failure. American Journal of Health-System Pharmacy. 60 Suppl 4:S3-6, 2003 Aug 15.

>more: The epidemiology and clinical characteristics of acute decompensated heart failure (ADHF) and the management of patients with ADHF are discussed. ADHF has become a significant health care problem in the United States. In an effort to fully understand the current epidemiology, clinical characteristics, and management of patients hospitalized with ADHF, a national registry was started in 2002 as a joint collaboration between academic heart failure specialists and the bio-pharmaceutical industry. The largest compilation of ADHF data has been collected in the Acute Decompensated Heart Failure National Registry (ADHERE). This article describes ADHERE, which suggests that the health care industry needs to conduct root-cause analysis of outpatient and inpatient practices toward these patients and make adjustments in these treatment patterns if we are going to reduce the morbidity, mortality, and health care costs in these patients.

Neily J. Ogrinc G. Mills P. Williams R. Stalhandske E. Bagian J. Weeks WB. Using aggregate root cause analysis to improve patient safety. Joint Commission Journal on Quality & Safety. 29(8):434-9, 381, 2003 Aug.

>more: The authors describe use of aggregate root cause analysis, which provides a systematic process for analyzing high-priority, frequent events.

Spath P. Reduce infections with root-cause analysis. Hospital Peer Review. 28(6):86-8, 2003 Jun.
[No abstract]

Batty L. Holland-Elliott K. Rosenfeld D. Investigation of eye splash and needlestick incidents from an HIV-positive donor on an intensive care unit using root cause analysis. Occupational Medicine (Oxford). 53(2):147-50, 2003 Mar.

>more: Background: Two doctors working on a busy intensive care unit sustained injuries whilst removing a chest drain from an HIV-positive patient. One doctor had a needlestick injury into his finger whilst the other sustained an eyesplash when the chest drain was pulled out.
Methods: Following Department of Health format 'Doing less harm', a root cause and human factor analysis of the incident was carried out. The aim was to explore the underlying issues.
Results and conclusions: Training, cultural and organizational issues were exposed, and are now being addressed. This approach has led to a far more effective dialogue with the National Health Trust concerned than was previously experienced, and there is early evidence of progress on important aspects of health and safety management at organizational level. Lack of health and safety training of doctors at undergraduate and postgraduate level needs to be addressed.

Heget JR. Bagian JP. Lee CZ. Gosbee JW. John M. Eisenberg Patient Safety Awards. System innovation: Veterans Health Administration National Center for Patient Safety. Joint Commission Journal on Quality Improvement. 28(12):660-5, 2002 Dec.

>more: Background: In 1998 the Veterans Health Administration (VHA) created the National Center for Patient Safety (NCPS) to lead the effort to reduce adverse events and close calls systemwide. NCPS's aim is to foster a culture of safety in the Department of Veterans Affairs (VA) by developing and providing patient safety programs and delivering standardized tools, methods, and initiatives to the 163 VA facilities.
A novel approach: To create a system-oriented approach to patient safety, NCPS looked for models in fields such as aviation, nuclear power, human factors, and safety engineering. Core concepts included a non-punitive approach to patient safety activities that emphasizes systems-based learning, the active seeking out of close calls, which are viewed as opportunities for learning and investigation, and the use of interdisciplinary teams to investigate close calls and adverse events through a root cause analysis (RCA) process. Participation by VA facilities and networks was voluntary. NCPS has always aimed to develop a program that would be applicable both within the VA and beyond.
Key action items and results related to RCA: NCPS's full patient safety program was tested and implemented throughout the VA system from November 1999 to August 2000. Program components included an RCA system for use by caregivers at the front line, a system for the aggregate review of RCA results, information systems software, alerts and advisories, and cognitive acids. Following program implementation, NCPS saw a 900-fold increase in reporting of close calls of high-priority events, reflecting the level of commitment to the program by VHA leaders and staff.

Connor M. Ponte PR. Conway J. Multidisciplinary approaches to reducing error and risk in a patient care setting. Critical Care Nursing Clinics of North America. 14(4):359-67, viii, 2002 Dec.

>more: In 1995, a medication error at Boston's Dana-Farber Cancer Institute (DFCI) that received intense media scrutiny, transformed the Institute in many ways. Primarily, patient safety became a major priority that led to Institute-wide organizational learning. As a result, DFCI emerged as a national leader in the patient safety movement. A key factor believed to have contributed to this effort was the use of a multidisciplinary team approach to identifying and preventing errors, with the patient and family members as an integral part of the team. In addition to teamwork, other activities included implementing a new chemotherapy order entry system, transforming the culture to a non-punitive one where staff are encouraged to openly discuss errors and safety issues, and introducing a root cause analysis process for error/near miss investigations. Several guiding principles served as the foundation for the efforts including: 1) systems, not individuals, must be the focus of safety initiatives; 2) organizations must create a non-punitive culture; 3) changes must be hard-wired into systems; and 4) multidisciplinary participation, including patients and families, is critical to success.

Bagian JP. Gosbee J. Lee CZ. Williams L. McKnight SD. Mannos DM. The Veterans Affairs root cause analysis system in action. Joint Commission Journal on Quality Improvement. 28(10):531-45, 2002 Oct.

>more: Background: The patient safety program in the Department of Veterans Affairs (VA) began in 1998, when the National Center for Patient Safety (NCPS) was established to lead the effort on a day-to-day basis. NCPS provides the structure, training, and tools, and VA facilities provide front-line expertise, feedback about the process, and root cause analysis (RCA) of adverse events and close calls.
Monitoring the process: Facility patient safety managers determine the disposition of adverse events and close calls occurring at their facilities. They use a safety assessment code (SAC) to prioritize the actual and potential severity and frequency of an event.
Before-and-After Study: Before the new RCA system was implemented in 2000, the VA used another adverse event reporting system, focused review (FR). A comparison of the two processes indicates that the RCA process has shifted analyses of adverse events toward a human factors engineering approach-entailing a search for system vulnerabilities rather than human errors and other less actionable root causes. CASE EXAMPLES: Two case examples--on hazards in the magnetic resonance imaging (MRI) room and on a cardiac pacemaker malfunction--illustrate how the RCA system works in actual operation. The cases illustrate that broadly applicable, high-impact actions can result from a thorough RCA process.
Discussion: NCPS monitors the quality and completeness of RCAs through the immediate review and feedback process. Still to be investigated is the effectiveness of RCA actions addressing the hypothesized root causes and contributing factors of the close calls and adverse events.

Hofer TP. Hayward RA. Are bad outcomes from questionable clinical decisions preventable medical errors? A case of cascade iatrogenesis [PDF] Annals of Internal Medicine. 137(5 Part 1):327-33, 2002 Sep 3.

>more: When a patient with multiple, complicated conditions is admitted to a hospital and risky procedures are performed that result in adverse outcomes, the difficulties inherent in determining whether and when a preventable medical error has occurred must be addressed. This article analyzes the case of a 40-year-old woman with a history of chronic aortic dissection and pericardial effusion who was admitted to a teaching hospital with unilateral swelling of her left breast and arm accompanied by dyspnea. During her hospitalization, the patient developed multiple complications from the diagnostic and therapeutic procedures that were performed. The authors argue that this case illustrates some limitations of routinely undertaking time-consuming and costly reviews, or "root-cause analyses," as a patient safety strategy when they are unlikely to reveal remediable "errors" or to suggest better systems of care that will prevent errors. The ability to establish causality through post hoc reviews is the linchpin in the recommendation for widespread adoption of error reporting and reviews. When causality is not established, it is impossible to know whether any changes adopted as a result of the reviews will be effective. This case, in which the causal pathways to the adverse events are very uncertain, may be much more typical than the egregious errors featured in a classic root-cause analysis. The authors recommend that the relative merits of this approach to patient safety be compared with other proven, cost-effective interventions to improve quality, such as appropriate treatment of myocardial infarction or depression, before scarce resources and enormous human capital are allocated for widespread implementation.

Anonymous. Integrating physicians into the root cause analysis process. Joint Commission Perspectives. 22(6):7-8, 2002 Jun.
[No abstract]

Boyer MM. Root cause analysis in perinatal care: health care professionals creating safer health care systems. Journal of Perinatal & Neonatal Nursing. 15(1):40-54, 2001 Jun.

>more: Medical error is a leading cause of death in the United States. The root cause analysis (RCA) process provides the framework for analysis of sentinel events and other medical errors. A thorough understanding of this process is a key component in promoting safety within the health care setting. Risk reduction strategies are presented to make this process meaningful and efficient while promoting the ultimate goal of safer health care systems.

Anonymous. Using Aggregate Root Cause Analysis to Improve Patient Safety. Quality Letter for Healthcare Leaders. 13(10):2-12, 1, 2001 Oct.

>more: A key to improving patient safety and providing quality care is identifying, reporting, reviewing, and addressing the problems that are related to adverse events and close calls. A tool that has evolved to meet this need is the use of root-cause analysis (RCA). But can more be done with the RCA to make it work smoothly within a health care setting--while providing useful information in a timely manner that health care organizations can act upon? Staff at the Department of Veterans Affairs involved with patient safety think so. Last month, they discussed numerous initiatives--ranging from "triage cards" to redesigned software applications to redefined leadership roles--that are giving a new edge to using RCA effectively throughout the 170-plus VA health care facilities across the country.

May T. Aulisio MP. Medical malpractice, mistake prevention, and compensation. Kennedy Institute of Ethics Journal. 11(2):135-46, 2001 Jun.

>more: Clinicians' fear of malpractice litigation is the most significant obstacle to the open reporting of medical mistakes. Without open reporting of medical mistakes, however, root cause analysis of mistakes cannot be done, thus undermining efforts to implement safeguards to minimize the occurrence of future mistakes. Efforts to prevent medical mistakes, therefore, must first directly address clinicians' fear of malpractice litigation. In this paper, we explore the relationship between the current malpractice system and clinicians' fear of litigation. Ultimately, we argue that both the prevention of medical mistakes and the goals of malpractice litigation itself will be better served if substantial malpractice reform is undertaken.

American Hospital Association. American Society of Health-System Pharmacists. Hospitals & Health Networks. Medication safety issue brief. Using a system-wide approach. Part 4 [PDF] Hospitals & Health Networks. 75(4):33-4, 2001 Apr.

>more: The meat and potatoes of error reduction is in the root cause analysis of mistakes and near-misses, and the identification of new, safer ways to carry out tasks. This is also the most technical part of patient safety. But hospital leaders find that their staffs can learn from mistakes using home-grown expertise and wisdom, and that it works best if everyone is willing to open up their daily work lives to some well-intentioned scrutiny.

Hofer TP. Kerr EA. Hayward RA. What is an error? [52 refs] Effective Clinical Practice. 3(6):261-9, 2000 Nov-Dec.

>more: Context: Launched by the Institute of Medicine's report, "To Err is Human," the reduction of medical errors has become a top agenda item for virtually every part of the U.S. health care system.
Objective: To identify existing definitions of error, to determine the major issues in measuring erro
Data source: Medical literature on errors as well as the sociology and industrial psychology literature cited therein.
Results: We have four principal observations. First, errors have been defined in terms of failed processes without any link to subsequent harm. Second, only a few studies have actually measured errors, and these have not described the reliability of the measurement. Third, no studies directly examine the relationship between errors and adverse events. Fourth, the value of pursuing latent system errors (a concept pertaining to small, often trivial structure and process problems that interact in complex ways to produce catastrophe) using case studies or root cause analysis has not been demonstrated in either the medical or nonmedical literature.
Conclusion: Medical error should be defined in terms of failed processes that are clearly linked to adverse outcomes. Efforts to reduce errors should be proportional to their impact on outcomes (preventable morbidity, mortality, and patient satisfaction) and the cost of preventing them. The error and the quality movements are analogous and require the same rigorous epidemiologic approach to establish which relationships are causal. [References: 52]

Rex JH. Turnbull JE. Allen SJ. Vande Voorde K. Luther K. Systematic root cause analysis of adverse drug events in a tertiary referral hospital. Joint Commission Journal on Quality Improvement. 26(10):563-75, 2000 Oct.

>more: Background: Adverse drug events (ADEs) occur frequently, and serious ADEs are associated with mortality or prolonged morbidity. As many ADEs are preventable, identification and modification of systems and processes that permit ADEs has the potential to reduce the rate of ADEs.
Methods: Root cause analysis was systematically employed in a blame-free fashion to investigate the patterns of serious ADEs that occurred during a 29-month period at Hermann Hospital (Houston), and process improvements were implemented on the basis of these findings. The consistently nonpunitive responses to the results of the initial and subsequent root cause analyses was gradually seen, accepted, and ultimately embraced by the hospital staff.
Results: The most commonly identified root causes were environmental factors (for example, increased census, increased acuity, change of shift) and staffing issues (for example, personnel new to a unit). Policy changes that led to increased use of forcing or constraining functions (for example, removal of concentrated intravenous potassium solutions from floor stocks) and better personnel support (for example, early awareness and response to localized increases in census and acuity) were particularly effective. Although limited by our lack of active surveillance and not necessarily directly due to the process changes that we implemented, the rate of voluntarily reported serious ADEs/100,000 patient days decreased during this time from 7.2 to 4.0, a decline of 45% (p < 0.001).
Conculsion: Systematic application of root cause analysis followed by implementation of process changes that target the underlying cause(s) of each event can be successfully implemented in a large hospital.

Croskerry P. Cognitive forcing strategies in clinical decisionmaking. Ann Emerg Med. 2003 Jan;41(1):110-20. Comment in: Ann Emerg Med. 2003 Jan;41(1):121-2.

>more: Cognitive errors underlie most diagnostic errors that are made in the course of clinical decisionmaking in the emergency department. These errors are universal and are prevalent in the special milieu of the ED. Their properties appear to be distinct from those associated with the performance of procedures. They are often costly, but, importantly for both the patient and the physician, they are also highly preventable. Recent developments in education theory provide a means for minimizing and avoiding diagnostic error. Through the process of metacognition, clinicians can develop cognitive forcing strategies to abort such latent errors. Three levels of cognitive forcing strategies are described: universal, generic, and specific. Specific cognitive forcing strategies provide a formal cognitive debiasing approach to deal with what have previously been described as pitfalls in clinical reasoning. This metacognitive approach can be taught to practicing clinicians and to those in training to inoculate them against making diagnostic errors. The adoption of this method provides a systematic approach to cognitive root-cause analysis in the avoidance of adverse outcomes associated with delayed or missed diagnoses and with the clinical management of specific cases.

Kenneth A. Hirsch, MD, PhD, Dennis T. Wallace, DABRM & Osborn, Denise, JD. Theory, Philosophy & Justification for Root Cause Analysis in Healthcare Organizations: Why Bother?
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