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Ann Thorac Surg 2005;79:11-15
© 2005 The Society of Thoracic Surgeons


Editorial

Focus on Patient Safety: Good News for the Practicing Surgeon

Thoralf M. Sundt, MDa,*, Jeffrey P. Brown, MEdb, Paul N. Uhlig, MDc STS Workforce on Patient Advocacy, Communications, and Safety

a Division of Cardiothoracic Surgery, Mayo Clinic, Rochester, Minnesota
b Safety System Group, Peterborough, New Hampshire
c Dartmouth Medical School, Dartmouth, New Hampshire, USA

* Address reprint requests to Dr Sundt, Division of Cardiovascular Surgery, Mayo Clinic, 200 First St SW, Rochester, MN55905 (E-mail: sundt.thoralf{at}mayo.edu).

The term "patient safety" is omnipresent; purchasers are asking for data, the government is passing legislation, and an increasing number of society meetings—the Southern Thoracic Surgical Association, and The Society of Thoracic Surgeons among them—are featuring speakers on the subject. While the fervor for this cause may seem to threaten to impose yet another bureaucratic burden upon a profession already under siege, it is in fact good news for the practicing surgeon. This editorial, written on behalf of the Society of Thoracic Surgeons (STS) Workforce on Patient Advocacy, Communication and Safety, is intended to explain why Thoracic Surgeons should not only take notice, but take charge of this movement.

Patient safety gained national attention in 1999 with the publication of the Institute of Medicine report "To Err is Man: Building a Safer Healthcare System," which estimated that between 44,000 and 98,000 Americans die each year of potentially preventable medical mistakes [1]. This study was met with criticism both for it's apparent hind sighted certainty [2] as well as methodological flaws that could have rendered these numbers several-fold too high or, for that matter, too low [3, 4]. Regardless of the exact count, however, we have certainly all witnessed medical error. Indeed many of us have experienced it either ourselves or with family members. We must accept that there is substantial evidence of, at minimum, thousands of deaths annually as a result of medical error in the United States [1, 5, 6].

How then are we to respond to the challenge from the public to address this problem? The good news is that the current focus on patient safety in fact provides thoracic surgeons leverage to take the next step in doing what we have always done—lead the way in improving the quality of care to our patients—while accomplishing efficiencies for all and reducing our own frustration in the daily struggle to provide the care we want for our patients. We can apply many of the lessons learned from the science of safety to our practice environment on a daily basis. It requires only a slight change in perspective on the problem.

What is Meant by Patient Safety?

Safety is, of course, a worthy pursuit. Who could fail to support any effort to improve safety for our patients? But what is meant by the term? When we speak of patient safety do we mean preventing accidents such as a fall from bed?

Safety can be defined as protection from experiencing or for that matter causing, harm, injury, or damage. As appealing as the term is as a call to action, it is difficult to develop a coherent plan of action around so general a concept. Students of the science of safety—the study of how safety arises in complex human activities that involve technology, risk, and uncertainty—more often focus on the concept of error and it's origins, prevention, and correction.

In common usage, errors may be defined as mistakes or incorrect decisions, actions, or judgments. In medical practice, however, a working definition is more complex. Do errors that result in no detectable harm "count"? What about errors that are caught, or "trapped," to use the language of safety? Is there a fundamental difference between system failures and individual missteps? Is there a difference between major and minor errors or errors of omission and commission? Indeed a spirited debate over the definition of medical error consumed the entirety of the first gathering of STS members on the subject of safety at the 2000 Annual Meeting. It is likely most expeditious to accept the broadest definition of error, and let the debate focus on the issue of which of these aspects of error are most likely to be productive in a given circumstance and given microenvironment.

But Don't We Already Monitor Errors?

As surgeons, we are justifiably proud of our tradition of peer review. Mortality and morbidity conferences are an integral part of our training and our culture. The ethos of introspection is manifest most conspicuously by the STS database, but is also at the core of our professional literature. The science of safety, however, differs in important ways from the outcomes analysis and continuous quality improvement that have become a hallmark of our specialty. Administering an incorrect drug is certainly an error, but it will be captured in an outcomes database only if it resulted in identifiable morbidity or mortality, an "adverse event" in the safety vernacular. Fortunately, the majority of errors or "glitches" do not lead to adverse events. As a result, such missteps, be they at an individual level or system level, are captured in a clinical database only indirectly if at all, and draw the attention of hospital administrators only if they cause sufficient harm to qualify as "sentinel events." We have become inured to many errors expecting "minor" deviations to be an inevitable part of the daily routine. Still, a missing laboratory test or an unread predischarge echo may lead to a delay in discharge or other inefficiency in care, which may be costly to the payer and frustrating to the patient and provider. Outcome analysis and error analysis may overlap, but they are not identical (Fig 1).



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Fig 1. Analysis of errors and analysis of outcomes overlap where adverse consequences ensue from the error. If the error is caught or corrected, it may be missed by tracking of traditional outcomes. Similarly, outcome may be impacted by procedure variables that are not currently recognized as errors, or by the patient's comorbidities.

 
Safety Science Perspective: The Inevitability of Error and the Importance of a System Perspective

The approach to safety in health care has traditionally focused almost exclusively on ensuring that individuals do not make mistakes. This simplistic view of error focuses on "the sharp end of the pyramid" (Fig 2) placing the entire burden of blame on individuals [7]. Yet we know as practitioners that events beyond our sphere of direct influence can profoundly impact our patient's care. Health care systems have become extraordinarily complex with broadly distributed interdependencies among people and constantly changing, sophisticated technology. Our approach to errors, however, has evolved little over the years. Other high risk/high consequence industries such as the nuclear power, high speed rail transportation, and aerospace accept that some level of error is inevitable in human endeavor. Recognizing this broadens the focus of their safety efforts from error prevention to what Helmreich has termed "error management" [8].



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Fig 2. Adverse events occur most obviously as the result of active failures on the part of individuals. The latent conditions for failure, however, reside in the environment in which the individual functions and may promote (or diminish) the likelihood that active failures will occur. The burden of responsibility for adverse events resides throughout the system, not solely on the individual practitioner perched at the peak of the pyramid. (Adapted from Reason JT. Engineering a safety culture: Managing the risk of organizational accidents. United Kingdom: Ashgate Publishing, Ltd, 1997.)

 
Human factors research has demonstrated that performance depends not only upon individuals, but also on organizational factors. Furthermore, the two are interrelated with adverse environmental factors potentially promoting the occurrence of human error. Equally, the system within which the individual functions can have a profound impact on trapping and recovery from error preventing adverse consequences. Just as a faulty system may set the individual up for failure, a robust system protects the patient and the practitioner. The importance of error trapping and recovery on outcome has been demonstrated in the context of cardiac surgery by de Leval and colleagues [9].

The environment in which all of us work—nurses, doctors, pharmacists, administrators, and patient alike—plays a fundamental role in accident causation and prevention by establishing the "latent conditions" for failure [7]. Subtle changes in the care environment, such as decreased nursing to patient ratios may appear to make economic sense in the short run, but may also create unsafe latent conditions. At some point, when errors happen to align with local vulnerabilities, failures result (Fig 3). James Reason [10] calls this the "swiss cheese" model of accident causation. Probability dictates that eventually failures will align like holes in the cheese permitting an accident to thread its way into existence. Accidents, in fact, are often unanticipated side effects of decisions made at an organizational level; changes made at the base of the pyramid aimed at improving efficiency may unintentionally create workplace conditions that undermine human performance at the sharp end [11]. Understanding and improving the conditions that may cause errors, therefore, becomes fundamental to improving patient safety. The responsibility for the work environment extends throughout our organizations, even to the board level. It is the caregivers on the front line that are able to identify these problems, not hospital administrators. That is why we as surgeons must be involved.



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Fig 3. In Reason's [10] "Swiss cheese" model of accident causation, adverse events occur when active failures align with gaps or weaknesses in the systems permitting an error to go untrapped and uncompensated. Efforts must be made to reduce the gaps as well as reduce the errors. (Adapted from Carthey J, et al. The human factor in cardiac surgery: errors and near misses in a high technology medical domain. Ann Thorac Surg 2001;72:300–5.)

 
What is the Practicing Surgeon to Do?

Each of us can contribute to improving safety for our patients. We can take measures to reduce our own errors, but the greatest leverage is obtained when we adopt a "systems perpective" recognizing that we function within a complex system—the system of care in our own "practice laboratories." Our present craft model of care, which relies so heavily on the individual practitioner, inadvertently results in fragmented care and gaps in continuity that cannot simply be overcome by working harder. Systems that align and coordinate the efforts of everyone involved must be introduced, and introduced in a way that facilitates the personal aspects of our care of our patients rather than separating them from us.

System redesign cannot be accomplished solely by sentinel event reporting and root cause investigations. Such efforts are influenced by innumerable biases including unrealistic expectations, fear of retribution, reporting bias, poor investigation procedures, flawed views of failure, analytical bias, rhetorical bias, classification problems, etc [12–14]. Near misses providing information on latent conditions may be completely overlooked by such approaches. Technology alone is not the answer either [15].

Help can be obtained from the large body of scholarship about safe systems and error management. Team-based error management methods, such as crew resource management (CRM), are applicable in any domain where safety and outcome reliability are primarily dependent on knowledge-based problem solving; ie, in complex, knowledge intensive, and highly skilled endeavors. Developed for the aircraft cockpit, CRM is equally applicable to the operating room and intensive care unit. Indeed these principles have already been adapted to the postoperative care of cardiac surgical patients with promising results [16]. Among the principles espoused is flattening of hierarchy to encourage active, cognitive participation by all members of the team including those at the bottom of the traditional chain of command. This can be accomplished by such simple interventions as reversing the order in which participants on rounds speak—starting with the staff nurse and finishing with the staff surgeon. Another simple rule is read back/repeat back—routine repetition of written or verbal orders, respectively, to the sender by the receiver. This is readily applied to all communications between surgeon and perfusionist with a minimum of effort, and can be more broadly applied to almost all verbal communication among caregivers. Similarly applicable are the results of task analysis. The most common human error is omission of necessary steps in a multistep process. Human factors research has demonstrated that some steps are more prone to omission than others (termed "affordances"), such as those with greater informational loading, those that are functionally isolated, recursive steps, etc. Characteristics of good reminders, in turn, have been defined (Table 1) and can be readily applied to many matters of routine in clinical practice [17]. The study of shift changes at NASA reveals the critical importance of formalizing such processes. The sign-out of patient care responsibilities by resident house staff, nursing staff, or cross-covering consultant staff should be informed by these results.


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Table 1. Universal Criteria for Good Reminders
 
As busy surgeons most of us will not have sufficient discretionary time to administrate major system redesign in the hospitals in which we function. We can all "lead from behind" by example, however, in our own practices and share what we learn with one another. Several concrete suggestions can be made:
1. Approach errors from a system perspective: when an error occurs, rather than seeking out an individual who is at fault ask where the system failed.
2. Pursue identification and corrections for all errors, not just those that result in harm, as they are subtle barometers latent conditions for failure in the system. While adverse consequences may not have occurred, the next time the error may not be trapped.
3. Flatten hierarchy in your practice: encourage junior members of the team to speak up and take time to listen to what they have to say.
4. Practice read back/repeat back where appropriate.
5. Employ effective task reminders to routine, repetitive procedures.
6. For those involved in training residents, insist on formal sign out at shift change.

Obstacles to Adopting a Systems Approach

To be sure, there are significant obstacles to accepting this emphasis on the role of the system in achieving safety. In addition to externally applied pressure from the legal system to find "the responsible party" when adverse events occur, we appropriately value our own professional ethos of personal responsibility to our patient at all hours of the day. We must recognize, however, that no single mind can perceive all that is happening at all times in such complex systems. An emphasis on autonomy at the expense of recognizing interdependence is maladaptive both for us and for our patients. Accordingly we must apply this sense of responsibility to our role within the system of care, and to improving that system. While individual responsibility remains, recognition of the importance of other factors in the occurrence of error expands the expression of that responsibility from a single-minded focus on the elimination of error to support of an environment that manages error. A climate of blame must be replaced by a climate of disclosure and openness.

Dare we adopt so open an approach to error despite the threat of litigation? We believe the answer is yes. The public appears ready to accept the notion of inevitability of error and a shift in thinking from individual blame to collective responsibility. The Columbia Accident Investigation Board investigating the break-up of the space shuttle upon reentering the Earth's atmosphere identified structural damage from a piece of foam that broke loose during takeoff as the proximate cause, but placed blame upon the program's culture, not on individual members of the team [18]. Per the accident report:

The Manned Space Flight Program has compromised the many redundant processes, checks, and balances that should identify and correct small errors. Redundant systems essential to every high-risk enterprise have fallen victim to bureaucratic efficiency. Years of workforce reductions and outsourcing have culled from NASA's workforce the layers of experience and hands-on systems knowledge that once provided a capacity for safety oversight;

Health care organizations, like the Manned Space Flight Program, do not manage garden variety, low-risk industrial activities. Sustaining awareness of the potential for failure in daily practice and then managing those risks well—continually detecting and intervening in small errors before they induce tragedy—is essential. It is our leadership privilege and professional responsibility to help bring those systems into existence in health care.

Why is This Good News?

So why is this good news? The potential benefits for our patients are obvious. The issue of patient safety can also be a powerful lever in dealing with the frustrations many of us feel in dealing with a health care system that seems to obstruct rather than facilitate care. Today we stand vulnerable at the "pointed end" of the safety pyramid subject to external political, legal, and economic pressure individually as practitioners. The science of safety demonstrates what we all know in our hearts: simply increasing pressure on the individual practitioner will not solve the problems health care faces today. The paradigm must shift.

Finally there is a personal benefit. Throughout our education as medical students and residents, surgeons are taught to be honest with themselves and their colleagues about errors and to learn from them. Some successfully deal with such errors, learning and moving on. Others defensively deny error, learning nothing from experience. Still others are crushed by the weight of responsibility for the consequences of those errors to their patients. If we are to keep the most compassionate and responsible people in the health care system, particularly in thoracic surgery, we must create a system that permits all of us to thrive by reducing the latent conditions leading to failure and lessening the burdens at the sharp end of care.

References

  1. Institute of Medicine (IOM) To err is human: building a safer health systemWashington, DC: National Academy Press; 199926.
  2. Hayward RA, Hofer TP. Estimating hospital deaths due to medical errorspreventability is in the eye of the reviewer. JAMA 2001;286:415-420.[Abstract/Free Full Text]
  3. Brennan TA. Institute of Medicine report on medical errorscould it do harm?. N Engl J Med 2000;342:1123-1125.[Free Full Text]
  4. Brennan TA, Mello MM. Patient safety and medical malpracticea case study. Ann Intern Med 2003;139:267-273.[Abstract/Free Full Text]
  5. Hofer TP, Kerr EA, Hayward RA. What is an error? Eff Clin Pract 2000;3:261-269.[Medline]
  6. Davis K, Schoenbaum SC, Collins KS, Tenny K, Hughes DL, Audet A-M. Room for improvement: patients report on the quality of their healthcare. Commonwealth Fund. April 2002..
  7. Merry MD, Brown Jeffrey. From a culture of safety to a culture of excellencequality science, human factors, and the future of healthcare quality. J Innovative Management 2001;7:29-46.
  8. Helmreich RL. Error management as organizational strategy: Proceedings of the IATA Human Factors Seminar, Bangkok, Thailand, 20–22 April 1998;1998:1–7..
  9. de Leval MR, Carthey J, Wright DJ, Farewell VT, Reason JT. Human factors and cardiac surgerya multicenter study. J Thorac Cardiovasc Surg 2000;119:661-672.[Abstract/Free Full Text]
  10. Reason JT. 1997Managing the risk of organizational accidents. Brookfield, VT: Ashgate Publishing; 19979.
  11. Rasmussen J. The concept of human erroris it useful for the design of safe systems?. Safety Science Monitor 1999;3::1-3.
  12. Johnson CW. Reasons for the failure of incident reporting in the healthcare and rail industriesIn: Redmill F, Anderson T, editors. Components of system safety: proceedings of the 10th safety-critical systems symposium. Berlin, Germany: Springer Verlag; 2002. pp. 31-60.
  13. Dekker S. Field guide to human error investigationAldershot, UK: Ashgate Publishing; 20023–51.
  14. Wiegmann D, Taneja N, von Thaden T. Medical incident reporting: current issues and future directions. Technical Report AHFD-02–16/FAA-02–3. December 2002..
  15. Patterson ES, Cook RI, Render ML. Improving patient safety by identifying side effects from introducing bar coding in medication administration J Am Med Inform Assoc 2002;9:540-553.[Abstract/Free Full Text]
  16. Uhlig PN, Nason A, Camelio A, Kendall E, Brown J. System innovationConcord Hospital section on John M. Eisenberg patient safety awards. Jt Comm J Qual Improv 2002;28:1-9.
  17. Reason J. Combatting omission errors through task analysis and good reminders Qual Saf Health Care 2002;11:40-44.[Abstract/Free Full Text]
  18. NASA. Space shuttle Columbia accident report. Washington, DC: Government Printing Office; August 2003:181..




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