Patient Safety Concepts
Can we get there from here?
Sten Westgard, MS
Our second lesson on Patient Safety examines the traits of an ideal safety culture - and compares current laboratory practices to those ideals. Does "lab culture" measure up to "safety culture"? What prevents us from reaching the ideal safety culture?
- What defines a Safety Culture
- Where are we now?
- Where are YOU now? A "Cosmo Quiz" for Patient Safety
- How do we get there from here? (And what's in our way?)
- References
with contributions from Dr. Herbert Malkus, PhD, DABBC, and Dr. Teresa Darcy, MD, MMM, FASCP, FCAP
In a previous lesson, we discussed the emerging dominance of Patient Safety in quality management. With new laws passed and new Patient Safety organizations forming, the momentum is clear. The Patient Safety era is beginning, an age that will not only emphasize better care but also better technology.
Patient safety is an organizational culture and its ideal state is described as the generative culture (sometimes also called an informed culture). This lesson describes in greater detail the composition of this culture, as well as a comparison of our current culture and the barriers that prevent us from getting “there” from “here.”
What defines a safety culture?
You can think of safety culture as the product of organizational traits. Safety culture is not only a product of actions and policies, but just as important, it is generated by the beliefs and values of the organization.
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Key Features of Safety Culture[1] |
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| Wary | "We believe in Murphy's Law" |
| The organization recognizes that people and equipment can and will fail, and plans accordingly. Management and workers also are mindful of when and where errors might occur and prepare contingencies for those possible failures. | |
| Informed | "Management is aware how things work - how they really work" |
| Accurate information about performance, errors, and dangers is sought out, encouraged and analyzed. Information flows both up and down the organization. This allows the organization to know where the “edge” is without going over it. The information also gives the organization a memory |
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| Just | "We don't shoot the messenger. (Except for the messengers who really, really deserve it.)" |
The organization makes a distinction between blame-free and culpable acts. Some errors are just the fault of one person and in those cases discipline is warranted, but those cases are far outnumbered by situations where the system is truly at fault. By recognizing those “blame-free” cases, the organization can honestly encourage employees to report errors, near-misses, worsening conditions, etc. This is the opposite of the “shoot the messenger” approach. Without this trait, the organization cannot be aware of its own problems, much less attempt to correct them.
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| Learning | "What we learned from the past will help us keep learning in the future" |
| The organization makes continuous systemic improvements, both in response to errors and to regular monitoring of the system. Ideally, the organization also challenges its own assumptions. It tolerates short-term difficulties and differing opinions about hazards. | |
| Flexible | "Everyone is empowered to steer the ship away from an iceberg." |
| The organization has a hierarchy, which works well under routine operation, but in times of crises, skill becomes more important than status. | |
In the safety culture literature, the bedrock of the safety culture is the just culture and the reporting culture. Employees must not be afraid to report errors, and their reports must be encouraged and quickly disseminated, analyzed, and acted upon.
A just culture is really a matter of management and organizational values, but a reporting culture has a significant technological and process component. It's not enough to encourage people to come forward. You must effectively gather the information, transmit that information to the proper managers, disseminate that information throughout the hierarchy, store the information in a flexible database, and analyze it from different perspectives to find underlying patterns and hazards. In aviation and other high risk industries, elaborate but efficient reporting systems are critical to the safety culture.
Where are we now?
Having described the key traits of an ideal patient safety culture, we can attempt to figure out where current laboratory healthcare practices stand. Note that we can't describe the place of every lab. At best, we can hope to make judgments about the state of “most” laboratories.
We asked two colleagues to help us assess the state of culture in the laboratory: Dr. Herbert Malkus, PhD, DABBC, Assistant Clinical Professor of Laboratory Medicine at the Yale School of Medicine, and Associate Director of Clinical Chemistry and Director of Automated Chemistry at Yale-New Haven Hospital; and Dr. Teresa Darcy, MD, MMM, FASCP, FCAP, Medical Director of the Clinical Laboratories of the University of Wisconsin Hospitals and Clinics, Associate Professor of Pathology at the Department of Pathology and Laboratory Medicine at the University of Wisconsin School of Medicine and Pubilc Health.
Wary:
Within the lab itself, Dr. Malkus comments, “The lab goes way beyond wary. Quality assurance systems have been developed to show that our end product has clinical value. We make no assumptions and have to prove every step of the way that our instruments and analytical processes are functioning.”[2]
However, when the laboratory interacts with the greater institution, Dr. Darcy says, the laboratory is often less wary. “The lab culture often assumes the person who came before identified the right patient, sent the right specimen, the lab piece is just analytical and reporting.”[3]
As an industry, healthcare is undeniably wary, but it can be wary of the wrong things: fear of admitting mistakes, fear of opening up the organization to liability, fear of retaliation by management. Laboratories are frequently driven by compliance mentalities. They are quite afraid of losing their accreditation, but if it's not on a checklist or a guideline, they don't worry about it (and often have no time to worry about it).
Even with the stress being placed on Patient Safety by JCAHO, the current atmosphere is at best selective in its wariness. The organization will concentrate on the specifically mandated patient safety goals, but possibly at the expense of other efforts. The bottom line is still to comply, not to worry.
Informed:
Within the laboratory, there is a wealth of data available. It's possible to be informed, if only the staff had the time to look at the right data. Dr. Darcy says, “We're so inundated with data that it's very hard to step back and see, 'What is this data telling us about what we're doing to keep patients safe.'”
Again, the bigger problem lies outside the department, in the gulf between the administration and the lab. Structural changes in healthcare have made it harder and harder for healthcare management to understand laboratory performance. It is now unlikely that upper management has any laboratory background. Management is undoubtedly aware of the costs of the laboratory, but probably knows little else about its operation.
Dr. Malkus comments: “The general feeling I get from hospital administrators is that 'a glucose is a glucose is a glucose,' no matter where it's performed or how it is performed, and that one manufacturer performs as well as another. All you need is manufacturer reagents and you're okay... I think that falls in the realm of belief, not science.”
Dr. Darcy echoes this observation: “New generations of doctors don't have any wariness when it comes to lab data. If it comes out a number, it's absolute. So they don't put the lab results in context anymore....No need to be wary about it and there's no uncertainty attached to it.”
Unfortunately, management is also acting on its ignorance. “More and more decisions in different institutions are being made by administrators and fewer and fewer decisions about instrumentation and methodology are made by laboratorians,” says Dr. Malkus.
Even within the lab, however, there is a growing distance between the laboratory director/manager and the bench level technologists. Many pathologists in charge of a laboratory are detached from the details of operation. The pathologists focus on areas of testing where pathologists traditionally dominate, (for instance, anatomic pathology) but for the routine matters of chemistry, for instance, they rely on subordinates.
Learning:
Without question, the laboratory is a place where constant systemic change occurs. The rapid introduction of new tests and new technology has mandated it. The laboratory has responded well to the challenge of learning new methods and new technologies. However, other aspects of a learning organization are not in evidence. As Dr. Darcy puts it, “You have so little time after getting past the crisis of the day.”
We know that training, staffing, and resources are always under pressure in healthcare. It is probably more accurate to say that laboratories are cost-cutting organizations, not learning organizations. Because of the chronic staffing problems for medical technologists, our bench level employees are becoming less skilled, less educated, and less informed. Not only do they find it harder to communicate up the chain of command, they also are in a more difficult situation: they have to do more and more testing with less staff and less training. It's becoming harder for them to stay informed of even their current routines, much less learn new ways to confront systemic problems.
Reporting culture:
“Health care does not report well. That is to say, the reporting of scientific facts, primarily biological ones, is well established and admirable standards for winnowing fact from opinion have been developed over the years, but reporting about individuals and systemic failings has been desultory at best. Messengers have been shot and the 'facts' being reported have not been regarded as scientific and, therefore, worthy of regard, let alone analysis and action.” [1]
Our laboratories report all kinds of data. In fact, the lab is the fount of a wealth of data on performance. But most of the data is either ignored or it can't be analyzed. For instance, even though QC data may be generated continuously, many laboratories only review their trends once a month. And often only the largest of errors are discussed. Small drifts go unnoticed until they become big problems.
Just:
Is healthcare just? Are we just in the laboratory? Certainly at Maryland General they were very unjust, at many levels in the hierarchy. “Bad apple” blaming and “Shooting the messenger” are probably still the predominant responses to a report of significant errors in the laboratory. Reporting of small errors are expected and encouraged, for instance, minor control drifts, calibration issues, lot change issues, individual specimen issues, etc. But ask yourself this – can you report a major problem about a test or an instrument or a staff person (i.e. on the scale of hundreds or thousands of test results affected) and not suffer retribution because of it? In the best labs, that is true, but in probably many labs, the unspoken rule is “Do your job and don't rock the boat.”
Dr. Malkus agrees. “The number one issue in laboratory QC/QA is getting fear out of the workplace and finding a reward system for those people who come with problems.” Indeed, Dr. Malkus believes that the managers should “question individuals who never come to you with a problem.”
Dr. Darcy again stresses the difference between lab culture and healthcare culture. “Healthcare in general is a blame-ful culture. I think the lab, more than other areas, is focused on processs and understands, 'Don't shoot the messenger.'”
Flexible:
The hierarchy in healthcare is pretty clear. Administrators and doctors have strong and clear authority over the laboratory. In times of crisis, the laboratory has more authority to do what is necessary, but its flexibility is curious. Dr. Darcy characterizes it as a “pleaser kind of culture. We really would like to bend over backwards to help. When a doctor calls for help, we want to help.” If a doctor asks for a rapid test result, even in the face of bad QC results, how does the laboratory respond? When administration and other departments ask the laboratory to be flexible and bend rules, often the laboratory is willing to do so. The laboratory has the flexibility to bend or break the rules to satisfy other parties up the chain of command, but not the flexibility to refuse requests that are dangerous.
When it comes to the problems seen by the laboratory but outside its boundaries, the laboratory has its usual problem. Dr. Darcy says, “We're empowered to see things but there's no organizational way to really move cross-departmental problems forward.”
Where are YOU now? A “Cosmo Quiz” for Patient Safety
If you're wondering how to assess your laboratory's place in the Patient Safety spectrum, there's a handy self-assessment quiz you can take.
Directions: For each question, answer Yes, ? (Don't know, Maybe, or Partially True), or No
| Checklist for assessing institutional resilience (CAIR)[4] | |
| Question | Answer |
| Patient safety is recognized as being everyone's responsibility, not just that of the risk management team. | |
| Top management accepts occasional setbacks and nasty surprises as inevitable. It anticipates that staff will make errors and trains them to detect and recover from them. | |
| Top managers, both clinical and non-clinical, are genuinely committed to the furtherance of patient safety and provide adequate resources to this end. | |
| Safety related issues are considered at high level meetings on a regular basis, not just after some bad event. | |
| Past events are thoroughly reviewed at high level meetings and the lessons learnt are implemented as global reforms rather than seeking to pin blame on specific individuals. | |
| Top management adapts a proactive stance towards patient safety. It does some or all of the following: takes steps to identify recurrent error traps and removes them; strives to eliminate the work place and organizational factors likely to provoke errors; brainstorms new scenarios of failure; conducts regular “health checks” on the organizational processes known to contribute to mishaps. | |
| It is understood that effective management of patient safety, like any other management process, depends critically on the collection, analysis, and dissemination of relevant information. | |
| Management recognizes the necessity of combining reaction outcome data (i.e. From the near miss and incident reporting system) with proactive process information. The latter entails far more than occasional audits. It involves regular sampling of a variety of institutional parameters (e.g. Scheduling, rostering, protocols, defenses, training). | |
| Meetings relating to patient safety are attended by a staff from a wide variety of departments and levels within the institution. | |
| Assignment to a safety related function (quality or risk management) is seen as a fast track appointment, not a dead end. Such functions are accorded appropriate status and salary. | |
| It is appreciated that commercial goals, financial constraints, and patient safety issues can come into conflict and that mechanisms exist to identify and resolve such conflicts in an effective and transparent manner. | |
| Policies are in place that encourage everyone to raise patient safety issues. | |
| The institution recognizes the critical dependence of a safety management system on the trust of the work force, particularly in regard to reporting systems. (A safe culture – that is, an informed culture – is the product of a reporting culture that, in turn, can only arise from a just culture.) |
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| There is a consistent policy for reporting and responding to incidents across all of the professional groups within the institution. | |
| Disciplinary procedures are predicated on an agreed distinction between acceptable and unacceptable behavior. It is recognized by all staff that a small proportion of unsafe acts are indeed reckless and warrant sanctions, but that the large majority of such acts should not lead to punishment. (The key determinant of blameworthiness is not so much the act itself – error or violation – as the nature of the behavior in which it was embedded. Did this behavior involve deliberate unwarranted risk taking or a course of action likely to produce avoidable errors? If so, then the act would be culpable regardless of whether it was an error or violation.) | |
| Clinical supervisors train junior staff to practice the mental as well as the technical skills necessary to achieve safe performance. Mental skills include anticipating possible errors and rehearsing the appropriate recoveries. | |
| The institution has in place rapid, useful, and intelligible feedback channels to communicate the lessons learnt from both the reactive and proactive safety information systems. Throughout the institution the emphasis is upon generalizing these lessons to the system at large rather than merely localising failures and weaknesses. | |
| The institution has the will and the resources to acknowledge its errors, to apologize for them, and to reassure patients (or their relatives) that the lessons learnt from such mishaps will prevent their recurrence. | |
Interpreting your score:
- Each Yes is worth 1 point.
- Each ? is worth 0.5 point.
- Each No is worth no point.
| Score | Diagnosis |
| 16-20 | So healthy as to be barely credible |
| 11-25 | Moderate to high level of intrinsic resilience |
| 6-10 | Considerable improvements needed to achieve institutional resilience |
| 1-5 | Moderate to high institutional vulnerability |
| 0 | A complete rethink or culture and processes is needed |
With greatest respect to the authors, this quiz has limited usefulness to those of us in the laboratory. The language and concepts of Patient Safety are just coming onto our radar screen and the laws and bureaucratic/organizational support are still emerging. So it should come as no surprise that our institutions aren't perfect when it comes to Patient Safety and that we've got a long way to go.
In some respects, this checklist assessment is like a “Cosmo Quiz.” For those outside the US, a “Cosmo Quiz” refers to a quiz often found in style and fashion magazines like Cosmopolitan, where a set of simple questions are asked, with sometimes bizarre conclusions drawn from the answers. Yet it gives the reader the illusion of a revelation – you may temporarily think you've learned more about yourself after taking the quiz. But really, all the quiz can do is tell you something you already know.
Nevertheless, if taking this quiz helps you identify some key issues, it's worth something.
How do we get there from here? And what's in our way?
So we have an idea of the goal and how far we need to go to get there. Now comes the troubling question, What stands in our way?
From the new Journal of Patient Safety, a group of 23 experts identified nearly thirty barriers to the implementation of Patient Safety Systems. The authors of this study found the following most significant barriers[5]:
| 1. Competing priorities for scarce resources in a system where patient safety is not considered a top priority. |
| 2. Lack of resources: inadequate staffing and work overloads |
| 3. Availability and cost of patient safety technology |
| 4. Resistance to change (the assumption that providers are already providing safe care). |
| 5. Culture of blame (current healthcare culture is punitive in nature). |
| 6. Lack of senior leadership understanding and involvement with patient safety issues. |
| 7. Culture of healthcare workforce perceptions, attitudes and behaviors of error “cover up.” |
If you've read this far, perhaps you've noticed something interesting: the very barriers to implementing Patient Safety are also the main problems that Patient Safety seeks to overcome. It's a tautology: if your organization doesn't consider Patient Safety a priority, that's a barrier to making Patient Safety a priority.
The reverse is probably also true: if you don't face those seven barriers, you've probably already implemented Patient Safety measures or something close to them.
The encouraging conclusion is that the struggle to make Patient Safety a priority is really part of the implementation strategy. That is, every step forward is progress, even merely setting the agenda of the organization. So if you're discouraged, take solace in the fact that talking about Patient Safety is part of the solution.
If Patient Safety is ultimately a culture issue, then part of transforming the culture involves discussing Patient Safety and making it part of the organizational dialog. Convincing your institution to embrace Patient Safety is probably half (well, maybe not half, but some fraction) of the battle to achieve a Patient Safety culture.
References
- P. Hudson, "Applying the lessons of high risk industries to health care", Qual Safe Health Care 2003:12(Suppl 1):i7-i12.
- Interview with Dr. Malkus, December 8, 2005.
- Interview with Dr. Darcy, December 7, 2005.
- J. Carthey, M. R. de Leval and J. T. Reason “Institutional resilience in healthcare systems” Qual. Health Care 2001:10;29-32.
- Ralista B. Akins, Bryan R. Cole, “Barriers to Implementation of Patient Safety Systesm in Healthcare Institutions”, Journal of Patient Safety, Volume 1, Number 1, March 2005, pp. 9-16.