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Inside the Lab Profession, Training and education, Quality assurance and quality control, Regulation and standards, Clinical care, Laboratory management

We Need to Talk: Pathologists, Patients and Diagnostic Errors – Part I

Mistakes happen, in medicine as in any other field. But medicine may be unique in the extent to which the scale of errors is contentious and perhaps unappreciated. A contributory factor, in many countries, is that deaths caused by medical errors can’t be identified as such on the death certificate – there is simply no option to do so (1). And if you’re not keeping records, you can’t know the scale of the problem.

At present, therefore, national estimates of error-associated mortality rely on indirect methods. These only give approximate evaluations, but some tell a frightening tale. A recent calculation (1) suggests that medical errors result in ~250,000 deaths per year in the USA alone – which would mean “mistakes” are the third most common cause of death in America. This figure is not universally accepted, however; an alternative narrative (2) proposes a lower estimate of ~25,000 error-associated deaths per year in the country.

Whatever the exact number, diagnostic errors may represent an increasing proportion of the total (see Infographic below). This may be partly due to the increasing complexity of healthcare; Ken Sands (Associate Professor of Medicine, Harvard Medical School) notes that the exponential growth in the number of branch points in a diagnostic investigation greatly increases the probability of a cognitive error. “It’s very hard to use standard safety systems, like checklists or forcing functions, to protect against cognitive errors, which is why we’ve found it difficult to reduce this source of patient harm,” he says. Thomas Gallagher (Professor and Associate Chair, Department of Medicine, University of Washington) agrees, commenting that diagnostic error is one of the main reasons why the medical profession has made disappointing progress on patient safety over the last 10–15 years. And Michael Laposata (Chairman, Pathology Department, University of Texas, Galveston) suggests that about a quarter of the US error-related deaths per year involve a diagnostic error (see Infographic below). “Never mind deaths from terrorism,” he says, “this number is enormous – and it’s totally overlooked.“

“Transparency is critical because it allows meaningful metrics – without knowing the denominator, we're never going to get a handle on any of this.” Suzy Dintzis

The problem is by no means limited to the US. Speaking from a Netherlands perspective, Laura Zwaan (Assistant Professor, Institute for Medical Education Research, Rotterdam) says “Diagnostic errors are significant but underappreciated. Existing estimates of the incidence rates suggest that 10–15 percent of diagnoses are not entirely correct,” and Cordula Wagner (Executive Director, Professor of Patient Safety, Netherlands Institute for Health Services Research, Utrecht) reminds us that diagnostic errors have a severe impact – “There may be more implications for the patient than in other types of error,” she says.

But again, diagnostic errors are not consistently recorded, and therefore their precise frequency is unknown. As Ken Sands points out, however, there is little point in arguing over whether the figure is massive or gargantuan; whichever number you pick, it is too big. Thomas Gallagher adds that research in the field is not sufficiently mature to reliably quantify the frequency of diagnostic error. “I would prefer that people focussed their energies on understanding why diagnostic errors occur and how to reduce them,” he says.

Exact incidence aside, growing concerns about the frequency and consequences of diagnostic error in the USA persuaded the Institute of Medicine (IoM) to convene a committee to further investigate. The Committee, which included Mark Graber, a founding member of the Society to Improve Diagnosis in Medicine, and colleagues such as Gallagher and Laposata, oversaw the development of the report “Improving Diagnosis in Healthcare,” issued in 2015 (3). The publication makes occasionally uncomfortable reading for both the medical and the legal community (see box “Uncomfortable Truths?“), albeit tempered with pragmatic suggestions for making our hospitals safer places. A key element of the report’s philosophy is full and prompt disclosure, not only to the healthcare institution where the error occurred, but also – critically – to the patients affected by the error. But how easy will this be for pathologists? Is it even possible?

Uncomfortable Truths?

Key findings from “Improving Diagnosis in Healthcare,” a report by the Institute of Medicine (IoM), Nov 2015 (3).

  • The diagnostic process should involve collaborative teamwork between healthcare professionals and their patients/patients' families.
  • Professional education and training relevant to the diagnostic process should be enhanced.
  • Healthcare IT systems should support the diagnostic process.
  • Diagnostic errors and near misses (see Note) should be identified, learned from and reduced.
  • A culture that supports mechanisms for improving the diagnostic process should be developed.
  • Introduce systems of error reporting and medical liability management that encourage identifying and learning from near misses.
  • Establish environment of payment and care delivery that supports the diagnostic process.
  • Funds for research on diagnostic process and diagnostic errors should be provided.

Note: “Near misses” are defined as “failures in the diagnostic process that do not lead to diagnostic errors.” “Diagnostic errors” are defined as “the failure to (a) establish an accurate and timely explanation of the patient's health problem(s) or (b) communicate that explanation to the patient.” 
(IoM Report)

“Diagnostic error has been called a blind spot – it's an area of safety that has been, to some extent, ignored.” Thomas Gallagher
Error disclosure: the silent treatment?

To answer those questions, we first need to look at the status quo of error disclosure. How often do healthcare professionals talk about their mistakes – either to their colleagues or to their patients?

The data aren’t always completely clear-cut. Suzy Dintzis (Associate Professor, Anatomic Pathology, University of Washington) points to results from surveys and focus groups in North America (See Table 1 and Table 2). These indicate that although 96 percent of surgeons report that they would definitely disclose an ‘error’ to patients, “in fact only about 10 percent would use the word error and even fewer would apologize to the patient.” By contrast, although only 65 percent of internists agree that they would definitely disclose an error to patients, Dintzis relates that 71 percent of these would use the word “error” and 43 percent would apologize (4). Thus, there may not be a common understanding of what exactly is meant by the term “disclosure.”

Furthermore, it seems that action does not always follow intent. Other surveys (5) suggest that an overwhelming majority of anatomic pathologists and laboratory medicine directors (96 percent and 99 percent, respectively) agree that serious errors should be disclosed to patients. Yet, while respectively 47 percent and 34 percent of these groups have been involved with a serious error, only 17 percent and 14 percent have actually disclosed a serious error to the patient. As Suzy Dintzis says, “There’s a gap between what they think they should do and what they’re actually able to do.” Clearly, the system prevents pathologists from being as transparent as they would wish. Why should this be?

It turns out that error disclosure may be hindered by a complex mixture of disincentives (6). These may vary in impact between countries, between individuals, and according to precise circumstances. To aid discussion, we outline disclosure difficulties under three categories: institutional disclosure, patient disclosure and general issues.

Table 1. Survey of 260 anatomic pathologists and 81 laboratory medical directors (response rate 51%). Data from Dintzis and Gallagher (4, 5, 11).
Difficulties in disclosing to the institution

It’s natural to be concerned about one’s reputation, and therefore, when things go wrong, instinct may tell us to keep quiet. As Laura Zwaan says, “The fear of what co-workers might think is an important factor.” Ken Sands elaborates further: “There has been a tradition of physicians feeling that they have to be perfect and that errors are not expected, or that they are a sign of professional incompetence.” Thomas Gallagher summarizes: “Physicians pride themselves on delivering very high quality medical care, and so when an error happens, it’s embarrassing.”

This attitude is not just motivated by ambition, if at all; the word that was consistently mentioned by experts in this context was “shame.” For example, Yael Heher (Anatomic Pathologist and the Director of Quality and Safety, Department of Pathology, the Beth Israel Deaconess Medical Center and Harvard Medical School, Boston) says, “As medical professionals, we’re very hard on ourselves; it’s very hard to accept that we’ve made a mistake – there’s a lot of shame around that.” And Cordula Wagner agrees: “People can be ashamed . . . and maybe also a little afraid of how it will look to their colleagues.“

But above and beyond reputation are fears for one’s actual livelihood. In cultures where discovery of medical errors tends to be followed by litigation, having one’s name associated with punitive patient compensation may not be a good career move. And in an age where an individual physician’s error record may be posted on the internet, error disclosure could result in a fall-off in patients for that physician – not good in cultures where physician payment is based on the fee-for-service system. “Error disclosure is potentially devastating for a professional career,“ says Laposata. He draws unfavorable comparisons between the medical community and the airline industry: “The airline industry gives pilots a medal for admitting that they had a near miss, because it helps everyone to understand where the risks are. And there’s no risk to the pilot’s job because the near misses aren’t publicized per person.”

Table 2. Survey of 2,000 US physicians and 2,000 Canadian physicians (response rate 63%). Data from Dintzis and Gallagher (4, 5, 11).
“The exact incidence rates of diagnostic errors are still unclear – it's very hard to determine the precise numbers” Laura Zwaan
“All of us will likely experience a meaningful diagnostic error in our lifetime.” IoM report, 2015.
“Pathologists believe that neither treating clinicians nor patients really understand the limitations of pathology.” Suzy Dintzis

But even if you remove reputational and employment concerns – even if the pathologist wasn’t responsible for the error – it can still be difficult for them to fully disclose errors that come to their attention. Why might this be? Laposata explains: “The pathologist is in a uniquely uncomfortable situation with regard to error reporting, because most of the mistakes we see are those made by our fellow physicians.” As Gallagher and colleagues point out (7), “Confronting the error of a colleague raises challenging questions about [. . . ]which professionals carry what responsibilities, and how to talk with the patient about the event.” A significant part of the problem, Laposata asserts, is that the pathologist is unsure of how to disclose that a colleague has completely misdiagnosed a patient; for example, does the pathologist talk to the physician, or does he go to his institution’s risk management officer? And Laposata is clear: “People have told me that risk management is their absolute last choice.”

“Our profession has not been good at recognizing that errors are part of being human.” Ken Sands
“There has been a cultural attitude that medical professionals are perfect and don't make any errors.” Cordula Wagner

But this semi-clandestine error reporting can contribute to errors remaining hidden, because by cutting risk management personnel out of the equation, the choice of how to proceed with the error tends to remain with the physician, at least in the US. And unsurprisingly – given the disclosure disincentives outlined above – sometimes the error report goes no further.

The consequences of this failure to fully disclose can be massive; Laposata points to cases where children have gone into foster care – and the parents have gone to jail – because a physician mistakenly concluded that a child with a cerebral hemorrhage had been physically abused, when in fact they had a bleeding disorder. Says Laposata, “I’ve found it virtually impossible to get people to admit that they overlooked a test in such cases, and that if they hadn’t they would have reached a different diagnosis.” He concludes, “Most people hold to their diagnosis in these circumstances because the admission of a mistake has huge consequences for them.”

Even where circumstances are less extreme – where a misdiagnosis leads to a delay in appropriate treatment, for example – healthcare professionals may still be fearful of the consequences of bringing an error to light. This is said to be particularly the case when working in an organization with a punitive culture. Notably, the IoM report references data suggesting that more than half of healthcare professionals appeared to feel that their employer was punitive with regard to errors.

But a punitive attitude to mistakes may itself be a consequence of the fault-based medical liability system (3) (discussed below), and is certainly a symptom of organizational culture, which itself is a function of many other factors. It’s starting to look like moving towards error transparency will require a large-scale, institutional or even supra-institutional effort.

Difficulties in disclosing to the patient

Directly disclosing errors to the patients themselves raises a new set of barriers. Obviously, there is the very human point that professionals don’t like to make mistakes, and therefore admitting to them can be painful. But it’s worse when you’re talking to somebody who has suffered for your mistake. Laura Zwaan points out: “It’s very difficult for healthcare professionals who not only have to bring bad news, but who are also partly responsible for it.”

To that very human concern must be added to the fear of litigation. This is a consequence of the “deny and defend” status quo, in which the default reaction of healthcare organizations is to deny responsibility for errors or any harm therefrom, resulting in courtroom battles and sometimes large financial settlements. As Heher says, “Anxiety about repercussions is emotionally powerful, and in the US a big portion of anxiety relates to litigation.”

Is “deny and defend” the best way of doing things? Perhaps not. From the patient perspective, it’s been said to be slow, inequitable, and inefficient; from the physician perspective, expensive, stressful and inclined to incentivize “defensive medicine,” i.e., the avoidance of higher-risk patients or procedures (3, 8).

According to this view, the current system sets up a tension between pathologists, who feel a moral obligation to disclose errors but are fearful of the consequences, and a system based on litigation and punishment. Fair enough; but does this tension actually change behavior? In other words, does the fear of litigation prevent pathologists disclosing errors?

“There's an enormous amount of shame and embarrassment that accompanies medical error.” Thomas Gallagher
“The pathologist is in a uniquely uncomfortable situation . . . most of the mistakes we see are made by our fellow physicians.” Michael Laposata
“Moving towards full transparency involves cultural change and is not easy, but it is the right thing to do.” Yael Heher
“We need a broad cultural shift.” Suzy Dintzis
“Healthcare professionals are afraid to talk about errors in case they say the wrong thing in terms of liability.” Laura Zwaan
“It's one thing to ask people to disclose within their institution – making it public is a step further.” Yael Heher

In fact, the results of surveys and focus group research suggest that fear of litigation may be less of an issue than many believe. Yael Heher asserts that most physicians have a very powerful moral compass and don’t need fear of litigation to drive their behavior in the right direction. Suzy Dintzis quotes data that support this: “In our survey only about 10–20 percent of pathologists said that litigation fear might deter them from disclosing a serious error to a patient.” She points to a survey of 2,000 doctors in the US and Canada; disclosure rates were identical in these two countries despite their very different litigation environments (see Table 2). “I think that’s the strongest evidence that litigation is not really a big factor,” she says. “It stresses you, but it doesn’t stop you.” Gallagher concurs: “The probability of being sued is about five times lower for a Canadian physician than for a US physician, so if fear of litigation were a significant factor, you would think that Canadian physicians would be much more willing to endorse open communication with patients than US physicians – but the two groups are virtually indistinguishable.”

Perhaps then the litigation environment acts as a general stressor, which contributes to an environment of non-disclosure, but only drives non-disclosure in particular circumstances. What other factors may discourage transparency among pathologists in particular?

General difficulties in error disclosure

Dintzis is clear: “The two major reasons are the concerns around communicating technically complex results to patients and physicians, and challenges in pathologists’ ability to communicate.” She continues, “Pathologists are not confident in their communication skills. They’re used to presenting their diagnoses in reports, but when they talk to individuals, they’re very afraid of being misrepresented or misunderstood.”

Dintzis quotes (9) one participant in a pathologist focus group as follows: “...my social skills are not such that I would ever want to (speak directly to the patient) – I’m not in pathology because I like meeting people.” Gallagher agrees: “Uncertainty over what to say, and lack of confidence in communication skills, is an important barrier to communication.” Cordula Wagner puts it like this: “They may not have the competence to explain the error to a patient – they don’t know how to speak about it, how to mention it to supervisors or heads of department, or what they are allowed to say about insurance, for example.”

Added to that, Dintzis says, is the lack of any pre-existing relationship between patient and pathologist; this can complicate initiation of any dialog. Hence another finding from surveys and focus groups – that most pathologists believe disclosure should be at the discretion of the treating clinician. Heher agrees, “As pathologists, we don’t have a pre-existing relationship with the patient, so we don’t even have a ready forum for this kind of discussion – we’d have to bridge a major gap and set up a meeting, and how should we do that?” And Gallagher says that many of the pathologists he’s spoken to in his research were very conflicted, feeling that they should be more involved in communicating with patients after pathology errors, but also that their fundamental relationship was with the treating clinician, not the patient. “They were very uncertain about how to proceed,” says Gallagher.

“Explaining complex results in a way that is not opaque, without going into a lot of technical detail, can be very challenging.” Suzy Dintzis
“Many pathologists haven't spoken directly to a patient in decades.” Yael Heher
“The image of a pathologist sitting in a room by themselves with a microscope . . . there's some truth in that.” Suzy Dintzis

On top of this communication skills issue is a feeling that the nuances of pathology, and its occasional ambiguities, are not always understood by physicians or patients (10). Indeed, some pathologists may feel that it would be more harmful for the patient to know about the error than to remain ignorant of it (10). Suzy Dintzis outlines data from focus groups suggesting that pathologists believe error disclosure is complicated by the difficulty in explaining pathology results. “Pathologic diagnosis can be very subtle and subjective, but many practitioners feel that diagnosis should be black or white – they don’t understand that it’s much more nuanced than that.”

Furthermore, the complexity of diagnostic processes may make it difficult to actually determine if an “error” has actually occurred; Cordula Wagner points out that trouble in deciding whether a diagnostic error was truly preventable results in “grey areas” that can add to the disincentive to disclose.

For all these reasons, it seems that pathologists in general are ill-prepared for involving patients in the error disclosure process (10), and may even have concerns about communicating with the treating physicians.

Furthermore, there may be systemic issues that make it difficult for pathologists to justify spending time and resources on the error disclosure process. In the US, at least, it seems that the physician remuneration system itself may not support activities relating to identifying, reporting and learning from errors. In particular, the US fee-for-service payment system (FFS) – by which healthcare professionals are reimbursed for each service they provide – may discourage error disclosure activities, or even generate perverse incentives. Thus, FFS does not encourage activities such as time spent in communication between clinicians, pathologists, and radiologists with regard to test ordering and interpretation, or time spent by pathologists or radiologists advising clinicians on the use and interpretation of specific diagnostic tests. Nor does it reward accurate over inaccurate diagnoses, nor encourage activities which result in a diagnosis that indicates that no treatment is necessary (3). Furthermore, healthcare professionals report that the system does not incentivize them to engage patients in the diagnostic process, often resulting in rushed communication (3).

As Michael Laposata points out, activities like running the lab and making sure that all the assays are accurate; advising a physician on the use, interpretation and significance of diagnostic tests; applying the various diagnostic tests that do not involve looking down a microscope; even running the normal array of blood and urine tests; these all pay little or nothing. He is clear on the issue: “The problem is that if you don’t incentivize people, if they can’t even make a living from providing advice about diagnostic tests, then you won’t retain the experts who can help patients.” Fortunately, reimbursement and payment issues don’t (at present) seem to be significant disincentivizing factors in Europe. “I’ve never heard of it having any influence on error disclosure here,”confirms Wagner.

Finally, the paucity of accepted protocols and guidelines for error disclosure may be another important factor in the failure to disclose. Indeed, the fact that broadly accepted protocols or guidelines for error disclosure have only recently become available may reflect a deeper absence of rigor in this whole field. For example, even the definition of diagnostic error has been uncertain; the most recent is given in the IoM report (3) (see Sidebar “Uncomfortable Truths?”), but others have been used historically (3).

To be continued…

Clearly, the status quo is unsatisfactory insofar as it embodies a number of human and system factors that disincentivize error disclosure. Something needs to change – but what, and how? The IoM report makes some recommendations for change, of which the key points are outlined by Michael Laposata (see “It’s Our Turn“). These and other points are discussed in more detail in Part II of this feature (July/August issue of The Pathologist). In the meantime, here are some concluding thoughts on how we might open up the discussion on error disclosure.

Firstly, pathologists want to be fully transparent, it seems; but in the absence of clear guidelines, what do they do - make it up as they go along? Indeed, what kind of guidelines exist, and what should the ideal disclosure protocol look like? Our next part of this feature examines progress in this field.

Whether or not litigation significantly changes disclosure rates among physicians as a whole, there seems no doubt that it is a significant contributor to stress and cultures of fear. Can this be changed, and if so how, and to what? Next month’s issue hears views from experts on this point.

Then, significantly, there is the question of what constitutes current best practice in the field of communication after a diagnostic error; also, what impact has best practice had in the real world? Has it really improved outcomes? In the second section of this feature, we hear from proponents and developers of communication and resolution programmes (CRPs).

And finally, but perhaps most importantly, we look at diagnostic error disclosure from the patient point of view. How important is full disclosure to them? What do they really want? And how might pathologists be trained and supported in having difficult conversations with a patient who may have been significantly harmed by a diagnostic error?

Diagnostic errors are difficult to deal with, and perhaps even more difficult to discuss; we hope that by bringing together the views of several experts in the field, we are contributing to increased transparency in this hugely important and problematic area.

“In the US, pathologists for the most part are paid only for looking through a microscope and making a diagnosis.” Michael Laposata
“Improving the diagnostic process is not only possible, but also represents a moral, professional and public health imperative.” IoM report, 2015.

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  2. KG Shojania, “Re: Medical error – the third leading cause of death in the US“, bit.ly/1OgoJfS. Accessed June 10, 2016.
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  8. MACRMI Meeting Presentation, “4th Annual CARe Forum“, April 19, 2016.
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  10. SM Dintzis, “Disclosing Harmful Pathology Errors to Colleagues, Treating Clinicians and Patients“, Practice Changers presentation, 5 May 2016, College of American Pathologists annual meeting, Seattle, USA.
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  12. Wikipedia, “United States military casualties of war“, bit.ly/1eHirp7. Accessed June 10, 2016.

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