Patient Safety Achieving a New Standard for Care (2004) / Chapter Skim
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Appendix F: Quality Improvement and Proactive Hazard Analysis Models: Deciphering a New Tower of Babel
Appendix F: Quality Improvement and Proactive Hazard Analysis Models: Deciphering a New Tower of Babel
Pages 471-508
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From page 471... ...
proactive hazard analysis tools -- including Health Care Failure Mode and Effect Analysis, Hazard Analysis and Critical Control Point, Hazard and Operability Studies, Proactive Risk Analysis -- are designed specifically to identify hazards and to prevent harm. Each tool has common ancestry in the application of the scientific method to process analysis pioneered by Shewhart and Deming; each has unique attributes and advantages.
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From page 472... ...
Many tools exist; the quality improvement and hazard analysis models that offer methodologies to make medicine safer include Six Sigma, Hazard Analysis and Critical Control Points (HACCP) , Failure Mode and Effect Analysis/ Healthcare Failure Mode and Effect Analysis (FMEA/HFMEA™)
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From page 473... ...
Proactive Hazard Analysis Tools (PHA) Total Quality Management -- TQM Failure Mode and Effect Analysis -- FMEA Continuous Quality Improvement -- CQI Healthcare Failure Mode and Effect Analysis -- HFMEA™ Toyota Production System Hazard Analysis and Critical Control Points -- HACCP Six Sigma Hazard and Operability Studies -- HAZOP Probabilistic Risk Assessment -- PRA For comparative purposes, we also include discussion of Root Cause Analysis under PHA tools.
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manufacturing, 1950s/1980s CQI: Berwick and Bataldan, 1980s Purpose Continuously improve quality by relentless focus on customer satisfaction Core methodology 1. Plan a process improvement.
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maintain performance and correct problems as needed Toyota, Alcoa General Electric Pittsburgh Regional Healthcare Initiative University of Virginia Health System; Virtua Health, New Jersey Focus on elimination of waste, Focus on near zero defects and control of empowerment of frontline workers gains once achieved
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1. Conduct a hazard analysis.
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If so, what are they? Chemical industry Aviation, nuclear power Telemedicine in European Union Environmental health risk assessment Compels parties to assess potential Models all combinations of failures that difficulties and devise mutually agreeable may lead to adverse events solutions
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Total Quality Management/Continuous Quality Improvement TQM/CQI is the earliest application of the scientific method to process improvement. TQM techniques have been applied widely in U.S.
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CQI has been eclipsed by other methodologies, including the Toyota Production System, Six Sigma, and reengineering. Still, CQI remains the predominant quality improvement philosophy and methodology in the health care industry today.
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One commentator describes its approach as "much like that of Total Quality Management, perhaps with a more aggressive goal." Proponents suggest that the relentless focus on error reduction provides a structure and focus missing from other QI techniques. Six Sigma has a five-step improvement cycle corresponding to the acronym DMAIC with the aim to continuously reduce defects: 1.
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A proposed advantage of Six Sigma over TQM is the former's focus on defects from perfect versus the latter's focus on improvement from variation in a mean.7 2. Proactive Hazard Analysis Tools: FMEA/HFMEA™, HACCP, HAZOPS, PRA, RCA PHA tools tend to be more prescriptive and to have more record-keeping and other requirements than QI tools.
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From page 482... ...
VHA hospitals have proceeded the furthest in using HFMEA™ although many hospitals across the nation are now using this tool in meeting the new JCAHO standards. Hazard Analysis and Critical Control Points HACCP is a systematic approach to the identification, assessment, and control of hazards.
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Conduct a hazard analysis preparing a list of steps in a process where significant hazards occur and identifying preventive measures.
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Probabilistic Risk Assessment The PHA tools already described are designed to eliminate or mitigate potential hazards or failures emanating from a single cause. Reliability and safety analysts in the aviation and other high-risk industries realized a need for a tool to understand multiple failures or combinations of failures that could lead to catastrophic occurrences.
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The most extensive is an application to anesthesia patient risk described later in this appendix. Root Cause Analysis RCA is a qualitative, retrospective approach to error analysis that is widely applied to major industrial accidents.
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QI and PHA tools also may be used in combination; for example, at Virtua Health in New Jersey, FMEA is used for planning purposes to identify a high-risk, hazardous procedure on which to use Six Sigma to implement and sustain a process improvement.13 Tools developed outside of medical care must be adapted to fit the requirements of this sector. Any QI/PHA tool will undergo some adaptation to fit into an organization's culture, structure, and individual requirements.
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From page 487... ...
We were unable to identify any central "clearinghouse" to enable health professionals to become familiar with these different approaches and to learn lessons from their adaptation through case studies or other methods. We suggest that the health care community -- especially professionals and institutions interested in patient safety and harm reduction -- would benefit from the existence of a central resource or clearinghouse on experimentation using various structured improvement tools and methodologies.
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account for as much as 90 percent of total work; in physical therapy, four key processes account for the same overall volume of activity.16 Examining medical care through the lens of key processes provides a helpful way to consider systemic improvement. One potentially fruitful way to do this is through medical specialties.
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HACCP demonstrates that every process contains multiple Critical Control Points that will vary, process to process. Two preconditions are necessary to identify Critical Control Points in medical care: first, the identification of core processes, and second, the availability and accessibility of data.
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The identification of failure modes and quality management deficiencies must lead to the development and institution of reasonable interventions to prevent adverse events. Multidisciplinary teams composed of an equitable mix of frontline health care workers (e.g., clinicians, safety/facility
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Each new system intervention brings with it a whole new set of potential failure modes and contributing factors that should be similarly proactively analyzed and prioritized for intervention. This, combined with the ever-widening scope of system complexities due to an aging patient population, increased numbers of the immune compromised, and the need to "fast track" new and more effective technological advances in medicine, raises the need to handle health care's current "patient safety paradox" with an organized, proactive collective consciousness.
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VI. CASE STUDIES Continuous Quality Improvement Two studies illustrate the promises and shortcoming of CQI.
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"Our study raises questions about whether CQI is the right model for making these changes."24 Hazard Analysis and Critical Control Points25 Morrison Management Specialists, a member of the Compass Group, is a leading provider of food service expertise to the health care industry. Morrison services approximately 500 health care facilities nationwide, including hospitals, long-term care facilities, and senior dining communities.
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Hazard Analysis and Operability Studies HAZOP has been successful in identifying security threats in certain safety-critical information and communication technology systems.26 CORAS27 (risk assessment of security critical systems) has used HAZOP for information security risk analysis involving medical databases and telemedicine.
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Whether used with or without other PHA techniques, HAZOP is an integral part of the CORAS risk management process, specifically the identification of threats involving confidentiality, integrity, and availability for a Web-based telecollaboration service. In at least one proactive risk analysis, CORAS used both fault tree analysis (FTA)
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Because the recall process itself is such a huge undertaking, the team narrowed the scope of the FMEA to include only that part of the process related to internal departmental responses to recall notices, with the understanding that once this FMEA was completed, the scope would be expanded. Likely failure modes were identi
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For example, internal processes involve delivery of DMC recall notices via e-mail notification. The failure mode included involved departments failing to receive the e-mail notification; the likely cause identified was failure to include the appropriate department/individual on the department's procurement e-mail notification list.
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The VA's HFMEA™ model is a five-step process that involves selecting a topic for analysis, selecting a team to do the analysis, mapping a flow chart of the high-risk process, identifying failure modes within the process, and, if necessary, redesigning the process. In its first application of HFMEA™ the VA asked its 163 medical centers to use HFMEA™ to analyze their contingency plans for their computerized, bar-code medication administration systems in the event of a power failure or other interruption to the system.
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These simple measures help to keep the HFMEA™ team organized and prevent the team from overlooking potential failure modes. • Limit the flow diagram of the process to no more than 10 to 12 steps; otherwise the diagram gets too large.
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500 PATIENT SAFETY such as machine malfunctions can be easily identified and corrected. Indeed, most of the progress in improving anesthesia safety over the past 25 years has been attributed to identifying and correcting technical risks.
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, who were concerned about drug abuse and behavioral problems. "The major contributors to the problems are much closer to home and the most beneficial measures are mundane, such as better supervision of residents and periodic retraining of all practitioners so that they get familiar again with situations that they may have forgotten because they only rarely occur." Root Cause Analysis A recent article in the Quality Grand Rounds series as presented in the September 3, 2002, issue of the Annals of Internal Medicine, deals with a patient who suffered multiple adverse events consistent with cascade iatrogenesis.
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The authors see the diagnostic uncertainty regarding the use of the spiral CT scan as pointing to an apprehension, namely the appropriateness of integrating new health care technologies prior to sufficient supporting evidence. With pulmonary embolism having been ruled out, physicians debated whether pericardiocentesis under cardiographic guidance should be performed in an effort to explain the patient's dyspnea and arm and breast swelling.
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The patient eventually recovered and was discharged after a 27-day hospital stay, with more than $200,000 in hospital charges and the need for long-term dialysis. Six Sigma Virtua Health, a not-for-profit community hospital system in southern New Jersey, adopted Six Sigma in 2000 to achieve operational goals.
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The team determined that simplifying and error proofing the process were the greatest opportunities to increase safety. The following chart shows the steps taken in the improvement phase: Six Sigma Anticoagulation Improvements: Virtua Health Process Step Deficiency Intervention Anticipated Benefit Weighing patients Done on admission Bed scales purchased Easier to weigh only 48% of time patients Lab–pharmacy No prior system to All patients on Detection of data link monitor efficiency heparin included in otherwise silent automated review, process failures; with manual ongoing review of charts comparison identified to target performance Heparin hold Unclear definition Clarification with Decreased process for aPTT of start time for physicians variation >240 seconds 6-hour interval Physician called for Unclear which ID of physician group Decreased aPTT >240 x 3 physician group responsible for miscommunication to call heparin order on initial order sheet
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The focus of this paper is to describe an approach for identifying opportunities for improvement and taking action that leads to results that matter to patients in a framework that is achievable in the typical community hospital setting."30 Toyota Production System The Pittsburgh Regional Healthcare Initiative (PRHI) is a collaborative effort by institutions and individuals that provide, purchase, insure, and support health care services in Southwestern Pennsylvania.
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At the point of patient care, the people doing the work are the experts and focus on the shared goal of meeting patient needs, one patient at a time. When a problem hinders work, the full-time team leader takes the lead, researching the problem by first determining what happened and asking the question "why" five times to determine the root cause.
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2002. Proactive Hazard Analysis and Health Care Policy.
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2001. Evaluation of 60 continuous quality improvement projects in French hospitals.
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