Abstract:Despite huge investment in quality and safety over the past two decades, healthcare is still failing to learn the lessons from its mistakes. Michael Buist and Sarah Middleton examine the reasons and call for a shift in medical culture
“…It should be understood as one of a succession of management fads (Abrahamson ; Walshe ) and actions without evidence (Doern and Onderdonk ). Buist and Middleton () summarized the situation:Despite the hundreds of millions of dollars that have been consumed by the quality and safety industry…nothing much has changed.…”
Accreditation to ISO/IEC 17025 is required for EC official food control and veterinary laboratories by Regulation (EC) No. 882/2004. Measurements in hospital laboratories and clinics are increasingly accredited to ISO/IEC 15189. Both of these management standards arose from command and control military standards for factory inspection during World War II. They rely on auditing of compliance and have not been validated internally as assessment bodies require of those they accredit. Neither have they been validated to criteria outside their own ideology such as the Cochrane principles of evidence‐based medicine which might establish whether any benefit exceeds their cost. We undertook a retrospective meta‐audit over 14 years of internal and external laboratory audits that checked compliance with ISO 17025 in a public health laboratory. Most noncompliances arose solely from clauses in the standard and would not affect users. No effect was likely from 91% of these. Fewer than 1% of noncompliances were likely to have consequences for the validity of results or quality of service. The ISO system of compliance auditing has the performance characteristics of a poor screening test. It adds substantially to costs and generates more noise (false positives) than informative signal. Ethical use of resources indicates that management standards should not be used unless proven to deliver the efficacy, effectiveness, and value required of modern healthcare interventions.
“…It should be understood as one of a succession of management fads (Abrahamson ; Walshe ) and actions without evidence (Doern and Onderdonk ). Buist and Middleton () summarized the situation:Despite the hundreds of millions of dollars that have been consumed by the quality and safety industry…nothing much has changed.…”
Accreditation to ISO/IEC 17025 is required for EC official food control and veterinary laboratories by Regulation (EC) No. 882/2004. Measurements in hospital laboratories and clinics are increasingly accredited to ISO/IEC 15189. Both of these management standards arose from command and control military standards for factory inspection during World War II. They rely on auditing of compliance and have not been validated internally as assessment bodies require of those they accredit. Neither have they been validated to criteria outside their own ideology such as the Cochrane principles of evidence‐based medicine which might establish whether any benefit exceeds their cost. We undertook a retrospective meta‐audit over 14 years of internal and external laboratory audits that checked compliance with ISO 17025 in a public health laboratory. Most noncompliances arose solely from clauses in the standard and would not affect users. No effect was likely from 91% of these. Fewer than 1% of noncompliances were likely to have consequences for the validity of results or quality of service. The ISO system of compliance auditing has the performance characteristics of a poor screening test. It adds substantially to costs and generates more noise (false positives) than informative signal. Ethical use of resources indicates that management standards should not be used unless proven to deliver the efficacy, effectiveness, and value required of modern healthcare interventions.
“…Having for the most part accepted the Reason 'Swiss Cheese' model of adverse events and adapted variations, most hospitals' response to adverse events has been to increase defences at the blunt end of the health-care organisation's administration [46]. These defences, in the hospital, take the form of dedicated quality and safety units and committees, electronic eventreporting systems and the development of appropriate standards linked to hospital accreditation [46]. The aim of each of these blunt end defence layers is to continually decrease the size of the holes in each defence layer, by more audits, meetings and root cause analysis projects combined with the use of the quality improvement cycle.…”
Section: The 'Swiss Cheese' Model Of Health Care and Hospital Settingmentioning
The James Reason 'Swiss Cheese' model of adverse event causation has been the predominant principle in the determination and prevention of health-care-associated adverse events for the last 20 years. This model was developed to understand the causation of large-scale organisational and industrial accidents. In principle, it looks for holes in the defence layers of a large organisation that are largely administrative and not the fault of individuals that may be directly involved with the accident. This model has limitations when applied to health care, where most of the errors or accidents are individual technical or competency deficiencies within a background of an ever-changing micro socio-cultural environment. As such, using 'Swiss Cheese' methodology, there has been an over reliance on looking for system issues in health care that has led to a decreased focus on the individual performance of the health-care professional and avoidance of difficult cultural workplace issues. Clinical futile cycles (CFCs) are a model of adverse event causation that primarily focuses on the interaction between the immediate healthcare professionals and patients and between health-care professionals. This focus allows for interventions that address issues such as clinical competency and the culture of the health-care environment.
“…The purpose of this article is not to detract from the process of RCA, rather to question why all too often despite, a RCA, the same mistakes are repeated often again and again. Indeed, overall, the incidence and outcomes from hospital adverse events (HAE), has not improved over the last two decades [1][2][3][4][5][6]. This is despite widespread recognition of the problem, extensive epidemiological research, and billions of dollars of investment into quality and safety programs [2,3].…”
The incidence of adverse patient events in hospitals has not improved over the last two decades despite enormous efforts in the area of Quality and Safety. Notably, the same errors are often repeated, even though previous reviews of these events have resulted in learnings, guidelines and policy. The traditional review of a Hospital Adverse Event (HAE) is most commonly a Root Cause Analysis (RCA) to find factors and conditions that caused or contributed to the HAE. The basis for the RCA is the James Reason Swiss Cheese model of adverse events developed from analysis of large- scale industrial accidents. In this model the HAE occurs when a patient deteriorating clinical trajectory broaches the hospital’s organisational and professional defences. The learnings from the RCA typically result in new or changed policies and procedures, and occasionally professional disciplinary review of the involved health care workers. Clinical Futile Cycles (CFC) is clinical action or intervention (or lack thereof) that has no patient benefit. Analysis of HAE by looking for CFC creates learnings that focus on the human factors of the involved health care workers, and more importantly the socio, politico, and fiscal cultural hospital environment at the time of the HAE. As such, the learnings focus not on limitations of the individual practitioners but rather, the greater environment that has them often ignoring, broaching or being oblivious to professional standards, and the already existent policy procedure and guidelines.
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