It’s Our Turn to Talk: Pathologists, Patients and Diagnostic Errors – Part II

In last month’s feature (1), Michael Laposata (Chairman, Pathology Department, University of Texas, Galveston) exhorted his colleagues in the pathology community to take their place as valuable, indispensable members of the diagnostic team – “It’s our turn,” he asserted. We also drew attention to the factors that may have discouraged physicians from medical error disclosure in the past: injured pride, shame, fear for one’s reputation and livelihood, a lack of confidence in one’s own ability to communicate technically complex results to patients and physicians, and an absence of any kind of pre-existing relationship with the patient from which to start a conversation. Awareness of these factors – as well as an appreciation of the scale and impact of medical errors in general and diagnostic errors in particular – has led to programs that seek both to encourage open communication and to support physicians who engage in such communication. Indeed, it may be that we are witnessing a cultural shift in healthcare organizations, resulting in greater willingness to explicitly endorse full transparency and to support it with training programs. Here, in the second of a two-part feature, we discuss these developments and how they might affect the error disclosure environment for pathologists and patients alike.

Disclosure protocols: where do we stand?

For many years, one of the most fundamental barriers to medical error disclosure was the lack of a body of clear, broadly accepted protocols and guidelines. This impeded transparency, and therefore also hampered system-wide learning and improvement, not least with regard to diagnostic procedures. As the Institute of Medicine (IoM) report points out (2): “Conducting analyses of diagnostic errors, near misses and adverse events presents the best opportunity to learn from such experiences and implement changes to improve diagnosis.” Yael Heher (Anatomic Pathologist and Director of Quality and Safety, Department of Pathology, the Beth Israel Deaconess Medical Center and Harvard Medical School, Boston) is clear on this point: “Systems learning is really important – we should examine the error from a systems perspective, honestly look at system vulnerabilities, and design quality improvements to reduce risk of error recurrence.”

Without accepted disclosure systems, it’s impossible to generate reliable national metrics and wide-ranging safety improvements. In addition to helping measure the problem, effective disclosure protocols give physicians much-needed guidance on how to go about communicating – when, how and to whom – when they are involved in a medical error.

Recognition of the impact of the guideline deficit is now leading to the development of medical error reporting protocols in different institutions and countries. Laura Zwaan (Assistant Professor, Institute for Medical Education Research, Rotterdam), who helped develop error disclosure guidelines for a Dutch hospital, confirms, “More and more of these protocols are being developed, certainly in the Netherlands but I believe also worldwide.” And Thomas Gallagher (Professor and Associate Chair, Department of Medicine, University of Washington, Seattle) points out that well-accepted guidelines, such as the CANDOR toolkit (4) and resources from the Collaborative for Accountability and Improvement (5), have recently become available.

Michael Laposata makes specific recommendations regarding the ideal formal disclosure pathway for diagnostic errors. Having a dedicated error disclosure function in each institution, Laposata suggests, would get pathologists out of an awkward position. He recommends that the internal evaluation should involve a person who has a role dedicated to patient safety and a clear understanding of the varying diagnostic challenges of different clinical situations  – and who is supportive of physicians faced with such challenges. This would result in a more nuanced appreciation of diagnostic error – one that recognizes that there are degrees of error as opposed to a simplistically binary “mistake/no mistake” approach.

In this context, Laposata cites the IoM’s suggestion of a “standard of avoidability,” which would take into account the relative difficulty of diagnosis. With this approach, negligence (where the error is inexcusable) would be at one end of the scale; at the other end would be cases where diagnostic criteria are less clear-cut and circumstances more complex, and where some instances of error are almost unavoidable. The increased granularity provided by this standard of avoidability approach, Laposata asserts, would ameliorate some of the concerns surrounding error disclosure – such as litigation fear (see next section).

Cultural environment – litigation, reputation, career

Developing efficient and supportive disclosure guidelines, however, will be of little benefit if healthcare professionals are too scared to use them, for example because of concerns over malpractice litigation, reputational damage or loss of livelihood.

In Europe, litigation does not seem to be a major concern – at present. According to Cordula Wagner (Executive Director, Professor of Patient Safety, Netherlands Institute for Health Services Research, Utrecht), “We are aware that litigation could turn into a problem, but are keen to avoid going in a direction which could tempt physicians to engage in defensive medicine or cover things up because of litigation fear.” This is why Laura Zwaan is pleased to see that the Netherlands’ biggest liability insurer has recently developed and distributed its own guidelines on error disclosure. As she points out, having an insurer endorse a disclosure route should allay the fear of liability. And Wagner emphasizes the utility of a discreet incident reporting system to which only the institute has access. “People from outside can’t see it, so if there is some kind of safety issue, people feel safe in reporting it.”

But perhaps more fundamental than litigation fear, in many countries, is the pressure brought by a punitive organizational culture. In many healthcare organizations, the prevailing mentality, says Zwaan, is one of “If you’re trying your best, you won’t make any errors,” But that’s not true. “Everybody makes errors,” says Zwaan. She continues: “We need to reassure healthcare professionals that errors can happen to anyone.”

In the litigation-rich environment of the US, physicians may particularly welcome systems that are perceived to foster transparency without jeopardizing individuals’ careers. The AHRQ-administered Patient Safety Organization (PSO) program and the Patient Safety and Quality Improvement Act (PSQIA – passed by Congress in 2005) were intended to confer privilege and confidentiality protections to patient safety information shared with PSOs (2). Through the PSO program, healthcare organizations can voluntarily – and, in theory, safely – disclose safety data to the PSO and receive advice on error reduction strategies. The idea is that the PSQIA confers privilege and confidentiality protections to healthcare organizations that share specific types of patient safety information with PSOs. For example, under the PSQIA, adverse event information reported to a PSO is protected from disclosure in medical malpractice cases (2).

Progress in implementing the PSO program is said to have been slow, however, and the actual impact of the program on patient safety and error disclosure remains unclear (2). Indeed, Gallagher relates that there has been some concern that this system may actually inhibit disclosure of errors to patients, because of the significant legal penalties attached to disclosure of error information that has been provided to a PSO: “The PSQIA has not had a major positive impact on communication with the patient about errors,” he says. Thus, fears relating to the consequences of disclosure may still trouble healthcare professionals even under the PSO system (2).

In response to this situation, de facto disclosure systems are being developed in some parts of the US, at least at the local level. These take the form of “safe table” forums, where healthcare professionals can discuss safety experiences in an open but legally-protected environment (2). Outcomes from such meetings, however, are not truly transparent – they are not shared beyond the organization concerned – and hence do not benefit the broader community.

Hence, some believe that additional strategies are required. For example, with regard to diagnostic errors, one of the recommendations of the IoM report is to develop an organizational culture in which all healthcare professionals feel that they can safely identify and learn from such errors: a so-called “just culture, ” which accepts that healthcare is complex and that people make mistakes. This type of culture should – without tolerating reckless behavior – console those who make errors, coach those who have at-risk attitudes, and only punish those who are reckless (2).

Somewhat ambitiously, the IoM suggests the need for change in the actual legal system in the US, citing the theoretical advantages of “administrative health courts.” These bodies – which permit non-judicial mechanisms of investigating and resolving cases of medical injury – would allow quick and equitable compensation without adversarial litigation. Furthermore, they would be based on the standard of avoidability approach noted above – not fault or negligence. This non-punitive philosophy is anticipated to help disclosure. 

The administrative courts concept is likely to face resistance, however, from stakeholders that benefit from the current tort-based system (2). Hence, the IoM favors a Communication and Resolution Program approach (CRP), such as that developed by the Massachusetts Alliance for Communication and Resolution following Medical Injury (MACRMI) (See “Simply the Right Thing to Do” below). The suggestion is that this is a more pragmatic way of giving physicians comfort that error admission would not automatically lead to accusations of incompetence or even negligence, as well as of providing systematic support and guidance in error communication and consequent safety improvements.

Communication and resolution programs (CRPs): a proven success CRPs are intended to provide a means of not only improving medical error disclosure, but also speeding up and making more equitable the system for compensating the patient for any harm suffered. Ultimately, CRPs are intended to improve patient safety. The fundamental idea is to create a culture in which early reporting of adverse events is the norm, where discussing the occurrence and effect of such events with patients is fundamental, and where the disclosure process leads to system-wide improvements where necessary. “CRPs emphasize the strong link between transparency and patient safety,” says Gallagher. “They posit not only the importance of early event reporting and open communication with the patient, but also a thorough event analysis – using up-to-date approaches – to understand the root causes, followed by development of prevention plans and proactive offers of financial compensation for patients who have been harmed by an error.”

Laposata adds, “With CRPs, we get early reporting of an adverse event, we work through it internally, and then we openly communicate with the patient.” Gallagher, who runs the Collaborative for Accountability and Improvement (5), a collection of stakeholders committed to supporting the development of CRPs, continues: “The essential ingredients of a communication and resolution program include a robust adverse event reporting system, because CRPs depend on having a reporting system that clinicians will use to report events immediately – you can’t resolve cases that you don’t know about.”

This all sounds fine in theory, but what kind of outcomes can we expect from CRPs in real life? Won’t increased transparency just lead to more disgruntled patients, and perhaps more lawsuits? In fact, it seems that CRP-associated increased error reporting actually results in fewer malpractice claims, as well as an improved safety culture (2). Gallagher points to encouraging data from programs at the University of Michigan and the Lexington VA Medical Centre in Kentucky; for example, the frequency of lawsuits, the time to resolution of claims that were filed, and the amounts that were paid were significantly reduced in the Michigan model. The suggestion, he adds, is that these programs have succeeded in reducing litigation costs not by improving the way they handle lawsuits, but by fundamentally improving the quality of care. In other words, institutions that participate in these programs may be harming fewer patients. More specifically, in terms of measurable outputs, a survey of plaintiffs’  lawyers dealing with the University of Michigan Health System (6) suggested that 71 percent had settled cases for less than they had litigated, 86 percent said transparency allowed them to make better decisions about which claims to pursue, and 57 percent admitted they turned down cases they otherwise would have pursued (See Infographic “The Proof is in the Program”).

Similarly, the experience of MACRMI may be instructive (6). MACRMI developed a CRP termed CARe – Communication, Apology and Resolution – which, in brief, is intended to emphasize the principles of disclosure, apology and fairness (See “Simply the Right Thing to Do”):

• disclose information when an unanticipated adverse outcome occurs, such information ultimately to include the results of any investigation of the event, explanations of its occurrence and proposals to avoid recurrence; 
• apologize where appropriate; 
• proactively offer fair financial compensation where appropriate, without the patient having to file a lawsuit.

MACRMI describes the effect of CARe as “transformational,” claiming that it has changed the error resolution system from reactive to proactive, and has replaced adversarial attitudes with advocacy, secrecy with transparency, and denial with apology and healing. Furthermore, a culture of individual blame has been replaced by a focus on system improvement, they say, and isolation of affected parties (including the physicians) replaced by supportive assistance (6). The effects of CARe introduction therefore seem to be highly encouraging, and unsurprisingly MACRMI is now promoting the dissemination of its CRP model throughout Massachusetts (2) (See “Simply the Right Thing to Do” and Infographic “The Proof is in the Program”).

The patient communication predicament

Notably, CRPs emphasize communication with those who have suffered as a result of a medical error. This is in line with the IoM’s view on the importance of resolving diagnostic errors through dialog with patients; indeed, patient communication is intrinsic to the IoM definition of diagnostic error: “A diagnostic error is the failure to (a) establish an accurate and timely explanation of the patient’s health problem(s) and the failure to (b) communicate that explanation to the patient.” In fact, the inclusion of communication failure as a key component of diagnostic error distinguishes the IoM definition from other definitions. Thus, the IoM report asserts that patients are central to reducing the incidence of diagnostic error; improved diagnosis, the IoM suggests, requires the establishment of partnerships between healthcare professionals, patients and their families (2).

And there are reasons to welcome these kinds of partnerships – open communication with patients is said to benefit doctors, patients and healthcare providers alike. Suzy Dintzis (Associate Professor, Anatomic Pathology, University of Washington, Seattle) reports that pathologists who have disclosed a medical error tend to feel positive about the experience and to experience some personal relief at having taken this step. For the patients, having open, personal communication channels – and, critically, an appropriate apology – seems to defuse the situation, making them less likely to feel victimized or ignored, and therefore less likely to pursue litigation. Indeed, institutions with an open disclosure policy may have lower numbers of litigation cases brought against them (See Infographic “The Proof is in the Program”). “Data show that transparency actually decreases litigation,” Heher points out.

Zwaan agrees: “ For patients, disclosure is incredibly important. The family always wants to know what happened, why it happened and what’s going to be done to prevent it happening again.” If patients get this information, Zwaan says, they often don’t see any need to file a complaint; thus, open and honest communication can prevent pain for everybody. Dintzis adds, “Disclosure to patients engenders trust in the system; if they feel something is being hidden from them, it’s very damaging to the relationship between patient and medical system.” And Wagner reiterates that patients aren’t always motivated by financial compensation so much as by the need to understand; to get an apology; to see that the mistake has resulted in changes that will prevent recurrence; and generally to rebuild their trust in the medical profession.

Indeed, patients who have sued often have been motivated by the perception that the truth was hidden from them (6).  Conversely, evidence suggests that disclosure generally reduces the intent to sue, promotes more favorable settlements, and reduces the size of the award (6).

Heher suggests that physicians sometimes may be afraid to have the opening conversation with the patient, perhaps because they may feel that they should have an explanation at the start of the disclosure process. “But we’ve found that patients prefer you to be honest and say that you’re not yet sure what happened, but that you’re looking into it,” she says. Gallagher agrees, “The more time that passes without the patient receiving a satisfactory explanation is adding insult to injury.”

An effective transparency culture will permit the establishment of processes that improve patient safety. Although there are some differences of detail between disclosure processes in different institutions, it seems that the majority of them adhere to a number of key steps. Gallagher is clear on the three main components of the disclosure process: information sharing, emotion handling and follow-up.

The first of these involves giving the patient the information they need in order to understand what happened to them. This may not happen immediately, of course; as discussed above, error disclosure is a process. Cordula Wagner is clear: “You must inform the patient within 24 hours. You may not know exactly what has happened, but you can let them know that an investigation is underway and when to expect further information.” Ken Sands (Associate Professor of Medicine, Harvard Medical School, Boston) asserts that an effective disclosure protocol should comprise a series of communications, starting with telling the patient that something went wrong and contracting to update them when more information is available. The next communication might be about what exactly went wrong, and the subsequent meeting might provide more information on how and why the event happened. Finally, says Heher, the patient should be provided with the root cause analysis, i.e., the institution’s analysis of the event – how it happened, and why.

And the third component, says Gallagher, is follow-up, which ultimately may include offers of compensation. Towards the end of the process, Sands says, the communications are about establishing if the patient suffered any loss. This may involve working with the malpractice insurer over a period of months before meeting again with the patient to address financial compensation, if any. “That again is a negotiation that occurs over a period of months,” he says.

The generally inclusive approach of CRPs is notable (6). Thus, among the lessons learnt during three years of CARe program implementation by MACRMI is that institutional risk management officers, patients (and/or their relatives) and the insurer should all work together to resolve the issue (6). In addition, MACRMI advises that patients should have attorneys during resolution conversations, and to this end the CARe program provides patients with a suggested attorney list (6). The trend is clear: disclosure is a process in which all parties collaborate and communicate, and in which the vulnerable parties are supported.

Training towards transparency

It seems, then, that there is a growing momentum behind the shift to transparency. But, given that pathologists are generally unprepared or reluctant to communicate directly with patients (1), 
how can they be supported in this movement? As Zwaan notes, “Healthcare professionals can definitely use help to communicate appropriately, and support regarding what to do and how to do it.” And Heher emphasizes the importance of bringing resources to people at the front line; in particular, she recommends bringing experts to advise healthcare professionals on how to have conversations with patients, and on who should be involved. “People who attempt it without support might find it difficult,” she says. “It’s not just junior doctors, it’s also established pathologists that need tools.” Heher suggests, at a minimum, providing healthcare professionals with an understanding of the key pieces of information that need to be exchanged during medical error disclosure. “Give them some tools and some language to help them formulate that information,” she advises. Wagner advocates making it easy for healthcare professionals by providing them with a pocket-sized card with reminders of what to say, what not to say, and a timeframe for actions. “That’s the way we’ve started doing it, and it works fine,” she asserts.

One key tool in the support system is specialized training. Zwaan reports that the same Dutch liability insurer that developed error disclosure guidelines has also developed a training program, and she herself has contributed to the development of similar programs. “Communication of errors is very hard,” she says, “so training is definitely helpful.” Role play may turn out to be an essential part of the training process. Wagner and Zwaan advocate training with a “fake patient,” an actor, to prepare for error disclosure. “Part of the aim,” says Wagner, “is to make physicians aware of how you could explain the error, and when you say sorry, what kind of words you could choose.”

Similarly, the University of Washington runs a course in communication skills each year, part of which is focused on error communication training through role play. Dintzis explains, “We break the residents and fellows into groups of three: one plays the patient who has been seriously harmed, another plays the pathologist disclosing the error to the patient, and the third is an observer.” The value of this simulation is evident both in objectively measurable improvements and in the subjective improved confidence among participants. “When people take our course, the thing that they remember is that role play,” says Dintzis. 

Gallagher also has experience in the training process. Removing the reflex to keep quiet after an error, he says, is one of the key aims of the training that he and his colleagues provide. Their object is to foster a mindset such that when physicians are involved in a significant medical error, their instinct will not be to keep the event to themselves, but to find someone at the hospital who can help establish what happened and support communication with the patient. “We also offer additional training, for example, regarding the financial resolution of these cases,” says Gallagher, emphasizing the holistic approach taken by his institution.

And Gallagher has a final point to make, one that should offer comfort to physicians who find themselves in a disclosure situation inasmuch as it recognizes the enormous emotional distress that accompanies these events – first and foremost for the patient, of course, but also for the clinician. Gallagher admits, “Healthcare organizations don’t always do a good job of supporting clinicians after errors – that’s not only bad for the clinician, it also affects the quality of care they deliver to subsequent patients.” Indeed, the idea that an effective disclosure protocol should protect the physician as well as the patient is increasingly accepted. As Gallagher says, “Programs should also incorporate care for the caregiver.” Zwaan concurs, stating that disclosure protocols should support not just the patient, but also the “second victims” – the healthcare professionals themselves. 

And that is why the efforts of the individuals and organizations mentioned in this feature surely can only be good, not only for patients, but also for physicians of every stamp – including pathologists.

The last word . . .

So, as the transparency movement gathers momentum, what are the key features of medical error disclosure and patient communication that physicians should remember? And what are the key take-home messages for pathologists who may need to deal with a diagnostic error?

One point is that consistently transparent error communication implies an organizational culture that supports this philosophy. The extent to which error communications give physicians cause for concern, suggests Wagner, “depends on the culture of the whole institution, and the culture within one’s group of direct colleagues.” Organization-wide cultural shift may require systemic actions that are beyond the gift of any one person; equally, however, each member of the institution can contribute to such change. As Heher says, “We need everybody to be on the same cultural page and to accept that the idea is not to judge others, but to enable transparent communication and hence to define clear goals for improving patient safety.”

To that end, the IoM provides some specific suggestions for helping this cultural shift to take root in pathology departments (2):

• identify high-priority areas where improvements would significantly improve diagnosis; for example, focus on the most common diagnostic errors, on “don’t miss” conditions that could lead to critical harm if overlooked, and on diagnostic errors that are easy to address;
• accreditation organizations and Medicare should require that healthcare organizations monitor the diagnostic process to identify, learn from and reduce diagnostic errors and near misses; 
• provide systematic feedback on diagnostic performance to healthcare professionals;
• routinely undertake post-mortems on a subset of patient deaths to check for diagnostic errors.

Key to establishing this type of culture is to introduce guidelines and systems that provide safe environments such that errors can be voluntarily reported without the threat of legal discovery or disciplinary action. This in turn will provide invaluable support to disclosing physicians and enable healthcare organizations to learn from diagnostic errors – and to introduce measures to address and prevent them (2). The examples provided within this article are evidence that establishment of very focused and supportive guidelines and programs can have a very positive impact for all and even reduce litigation – in a litigious society! But more importantly, the overall result is one of a reduced incidence of diagnostic error leading to patient harm, and a better quality of working life for healthcare professionals and, in particular, for pathologists.

Nick Miller is Associate Editor of The Pathologist.