March 25, 2013
The seminal Agency for Healthcare Research and Quality (AHRQ) Making Health Care Safer report, (1) issued in 2001, was the first effort to use evidence-based medicine principles in identifying practices to improve patient safety. Though its recommendations proved controversial—drawing criticism for both the practices that were included and some that were omitted—the report galvanized patient safety efforts at hospitals nationwide and laid the foundation for further rigorous research, resulting in some of the most prominent successes in the safety field. In the past decade, thousands of lives have been saved thanks to innovative efforts to reduce health care-associated infections, (2) prevent surgical complications, (3) and improve teamwork among clinicians. (4) The culture of health care is changing, slowly but surely. Efforts to build a climate of safety among clinicians, including the integration of patient safety and quality improvement principles into training programs, are gradually eliminating the "blame and shame" response that impeded progress in patient safety for decades.
Despite these success stories, the sobering truth is that, overall, patient safety has not improved throughout the past decade. Landmark studies indicate that the prevalence of preventable harm likely has not changed over the past several years, (5) and some of the highest-profile efforts to improve safety thus far—such as restricting resident work hours (6) and investing in health information technology—have resulted in additional costs (in terms of manpower, time, and finances) without tangible benefits for patients or clinicians.
The publication of Making Health Care Safer II (7) therefore arrives at a pivotal turning point for the patient safety field. Through a rigorous process combining traditional systematic review methodology with the judgments of key stakeholders and technical experts in the field, the authors critically examined the evidence supporting 41 separate patient safety practices (PSPs). In addition to the effectiveness of the practice, the report also explicitly considered implementation, context, and cost in determining which practices should be operationalized. The resulting list of 22 practices, categorized as either "encouraged" or "strongly encouraged," could, if universally implemented, produce significant reductions in preventable harm. Some of the 10 "strongly encouraged" practices meet the criteria for "accountability measures" (8)—they have a strong evidence base documenting effectiveness, are measurable at the point of care, are closely linked to clinical outcomes, and lack significant unintended adverse consequences—and have already been widely implemented in a broad range of contexts. Guidelines promoting the use of these PSPs should be developed and disseminated, and it would be appropriate to also develop formal accountability performance measures (see Table 1) for both processes and outcomes relating to these practices.
However, organizations and policymakers should be mindful of Maimonides' maxim: "the physician should not treat the disease, but the patient who is suffering from it." Although "Making Health Care Safer II" identifies several key interventions that should be widely used, perhaps the report's most important contribution is that it exposes the need for a deeper understanding of our own systems, and that the optimal solutions for improving patient safety will require fundamental reengineering of how care is provided.
All 10 of the "strongly encouraged" practices target specific clinical adverse events, such as health care-associated infections and pressure ulcers. Hospitals that successfully implement all 10 practices should prevent adverse events, improve the patient experience, and likely save lives. But therein is the rub. Adverse events are manifestations of underlying systems that are broken, and focusing on preventing individual errors ignores the reality that many of these harms are interdependent. Successful implementation of the recommended PSPs will require organizations to understand their own cultural norms and system weaknesses that allow errors to happen and inhibit solutions. Hospitals will need to treat the entire system, not just the individual error.
For example, three of the "strongly encouraged” practices are explicit checklists, and another two are conceptually similar multi-component interventions ("bundles"). Undeniably powerful tools, checklists have been the foundation for many of the most prominent successes of the safety movement. Though often described as a "simple" intervention, in truth, successful checklist implementation requires clinicians to adopt specific practices (such as using chlorhexidine for skin antisepsis before inserting a central venous catheter), as well as make sociocultural changes (such as conducting a multidisciplinary time-out before beginning the procedure). An ethnographic analysis (9) of the influential Keystone Intensive Care Unit (ICU) study in Michigan showed that, far from being a simple intervention, the use of checklists in preventing catheter-related bloodstream infections (CRBSIs) was only one aspect of a complex intervention that emphasized teamwork, development of safety culture, rigorous data measurement and feedback, and the reframing of CRBSIs as a social issue in order to build a shared sense of commitment in eradicating the problem. The Keystone ICU authors have underscored a point that bears repeating: "The answer to the question of what a simple checklist can achieve is: on its own, not much. (10) The same could be said of virtually all of the recommended practices in "Making Health Care Safer II"—simply rolling out the checklist (or the "Do Not Use" list, or the ultrasound machine) and telling frontline clinicians to use it will not improve patient safety.
Another of the recommended practices, rapid response teams (RRTs), also represents an intuitively simple concept: when a hospitalized patient demonstrates signs of imminent clinical deterioration, a dedicated team is summoned to the bedside to immediately assess and treat the patient with the goal of preventing adverse clinical outcomes. There is some (albeit relatively weak) evidence indicating that RRTs can prevent cardiopulmonary arrests, (11) and RRTs have proven a very popular intervention among nursing staff. Some form of RRT exists at most U.S. hospitals, thanks in part to a 2008 Joint Commission National Patient Safety Goal that mandated hospitals maintain a system for bedside staff to obtain immediate assistance for unstable patients.
Despite this, our understanding of how RRTs can improve inpatient care remains very limited. The literature shows wide variation among team composition, frequency of use, and approaches to implementation across different institutions. More crucially, RRTs represent one of several potential approaches to advance safety for acutely ill inpatients, and the "best" approach likely depends on the underlying reasons for a patient's deterioration. If overworked bedside nurses are unable to properly monitor patients, a hospital might gain more benefit by simply hiring more nurses—especially since lower patient-to-nurse ratios are consistently associated with improved clinical outcomes. Patients being routinely "boarded" in the emergency department or admitted to overflow wards may indicate an underlying mismatch between clinical resources and patient needs, meaning that geographic localization of patients or measures to improve throughput could be effective. If authority gradients inhibit communication between clinicians on the wards, interventions to enhance the culture of safety, such as teamwork training or simulation training, could help escalate care for sick patients without needing to add more specialists to the mix. Many patients may not want (or need) additional interventions at the end of life, so better documentation of a patient's preferences for life-sustaining treatment could help allocate available resources to patients who would benefit the most.
Fundamentally, the mixed performance of RRTs illustrates the flaw of attempting to treat the disease (failure to rescue deteriorating patients) without understanding the patient (the hospital system of care). Patients often suffer cardiopulmonary arrest on hospital wards, despite warning signs present for hours before the event. But these cases are merely symptoms of a sick system. Adopting a reactive, one-size-fits-all solution like an RRT without also analyzing and addressing the underlying reasons why patients decline unattended will likely accomplish little. The fundamental answer to preventing in-hospital clinical deterioration and cardiac arrests ultimately lies in proactively reengineering systems to prevent such deterioration in the first place.
How can this be accomplished? First, health care must integrate expertise from other fields—particularly human factors engineering and systems engineering—to design safer systems. Second, and perhaps of equal importance, methods to improve safety culture must be rigorously studied and disseminated. One such intervention, teamwork training, reduced surgical mortality in a Veterans Affairs study; (4) further research should define the key elements of such interventions in different patient (and provider) populations, as well as examine the interaction between technical interventions and tools that emphasize cultural change. Finally, the field should achieve consensus on standardized, reliable, and reproducible measurements for common safety problems. The example of health care-associated infections, for which the Centers for Disease Control and Prevention has developed standardized measurement techniques, should be followed. It will be impossible to know if safety is truly improving unless safety can first be accurately measured.
The publication of "Making Health Care Safer II" may, in Churchill's famous words, represent "the end of the beginning" for the patient safety movement. Just as clinicians should "treat the patient, not the disease," the patient safety field will need to prioritize redesigning systems over targeting individual error types in order to achieve the ultimate goal—the creation of a highly reliable health care system that minimizes preventable harm for all patients.
Sumant Ranji, MD
Quality and Safety Programs
UCSF Internal Medicine Residency Program
San Francisco, California
The views and opinions expressed are those of the authors and do not necessarily state or reflect those of the National Quality Measures Clearinghouse™ (NQMC), the Agency for Healthcare Research and Quality (AHRQ), or its contractor ECRI Institute.
Potential Conflicts of Interest
Dr. Ranji is a member of the NGC/NQMC Core Editorial Board and was a contributing author for Making Health Care Safer II: An Updated Critical Analysis of the Evidence for Patient Safety Practices . He declares no financial or personal conflicts of interest with respect to this commentary.
Table 1. "Strongly Encouraged" Patient Safety Practices and Potential Accountability Measures
|Patient Safety Practice||Proposed Process Measure||Proposed Outcome Measure|
|Preoperative checklists and anesthesia checklists to prevent operative and post-operative events||Checklist usage||Risk-adjusted postoperative mortality for selected procedures|
|Bundles that include checklists to prevent central line associated blood stream infections||Checklist usage||Catheter-related bloodstream infections (CRBSI) rate|
|Interventions to reduce urinary catheter use which include catheter reminders, stop orders, or nurse-initiated removal protocols||None||Catheter-associated urinary tract infection (UTI) rate|
|Bundles that include elevation of head-of-bed, sedation vacations, oral care with chlorhexidine, and subglottic suctioning endotracheal tubes to prevent ventilator-associated pneumonia (VAP)||Bundle adherence||VAP rate|
|Hand hygiene||Observed hand hygiene rate||Rate of selected health care-associated infections|
|The Do Not Use list for hazardous abbreviations||None||None|
|Multicomponent interventions to reduce pressure ulcers||Documentation of intervention use||Pressure ulcer rate|
|Barrier precautions for the prevention of health care-associated infections||None||Rate of selected health care-associated infections|
|Use of real-time ultrasound for central line placement||Documentation of ultrasound use||Mechanical and infectious complication rates after line placement|
|Interventions to improve prophylaxis for venous thromboembolism||Proportion of eligible patients administered pharmacologic prophylaxis||Hospital-acquired VTE rate|
- Shojania KG, Duncan BW, McDonald KM, Wachter RM, eds. Making Health Care Safer: A Critical Analysis of Patient Safety Practices . Evidence Report/Technology Assessment No. 43 from the Agency for Healthcare Research and Quality: AHRQ Publication No. 01-E058; 2001.
- Pronovost P, Needham D, Berenholtz S, et al. An intervention to decrease catheter-related bloodstream infections in the ICU. N Engl J Med. 2006;355:2725-32.
- Haynes AB, Weiser TG, Berry WR, et al; for the Safe Surgery Saves Lives Study Group. A surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med. 2009;360:491-9.
- Neily J, Mills PD, Young-Xu Y, et al. Association between implementation of a medical team training program and surgical mortality. JAMA. 2010;304:1693-1700.
- Landrigan CP, Parry GJ, Bones CB, Hackbarth AD, Goldmann DA, Sharek PJ. Temporal trends in rates of patient harm resulting from medical care. N Engl J Med. 2010;363:2124-34.
- Landrigan CP, Fahrenkopf AM, Lewin D, et al. Effects of the Accreditation Council for Graduate Medical Education duty hour limits on sleep, work hours, and safety. Pediatrics. 2008;122:250-8.
- Shekelle PG, Wachter RM, Pronovost PJ, et al. Making Health Care Safer II: An Updated Critical Analysis of the Evidence for Patient Safety Practices . Comparative Effectiveness Review No. 211. (Prepared by the Southern California-RAND Evidence-based Practice Center under Contract No. 290-2007-10062-I.) AHRQ Publication No. 13-E001-EF. Rockville, MD: Agency for Healthcare Research and Quality. March 2013.
- Chassin MR, Loeb JM, Schmaltz SP, Wachter RM. Accountability measures—using measurement to promote quality improvement. N Engl J Med. 2010;363:683-8.
- Dixon-Woods M, Bosk CL, Aveling EL, Goeschel CA, Pronovost PJ. Explaining Michigan: developing an ex post theory of a quality improvement program. Milbank Q. 2011;89:167-205.
- Bosk CL, Dixon-Woods M, Goeschel CA, Pronovost PJ. Reality check for checklists. Lancet. 2009;374:444-5.
- Chan PS, Jain R, Nallmothu BK, Berg RA, Sasson C. Rapid response teams: a systematic review and meta-analysis. Arch Intern Med. 2010;170:18-26.