Pathologists expect rising prestige through greater collaboration
Interview by Steve Halasey
It has been more than 15 years since the Institute of Medicine (IOM) released its frequently cited landmark report on the problem of preventable medical errors, To Err is Human.1 While that report remains a touchstone for efforts to reduce and eliminate harms that might befall patients while undergoing medical treatment, little attention has been paid to errors that occur while a patient’s condition is being diagnosed. Until now.
In September, IOM released the latest in its series of publications focused on the quality of medical care in the United States, Improving Diagnosis in Healthcare, which examines current knowledge about diagnostic error and recommends methods for improving diagnostic processes.2 The report finds that most people will experience at least one diagnostic error in their lifetime, sometimes with devastating consequences, and concludes that “urgent change is needed to address the issue of diagnostic error, which poses a major challenge to healthcare quality.” (For more information, see the companion article, “IOM Report Recommendations.”)
Making the changes necessary to improve diagnostic processes will require a significant commitment of time and talent from professionals in the field. To find out how pathologists view the recommendations of the IOM report, CLP recently spoke with Gene N. Herbek, MD, FCAP, medical director at Methodist Women’s Hospital Laboratory, Omaha, Neb, and president of the College of American Pathologists (CAP).
CLP: CAP is one of a number of organizations that sponsored the new IOM report on diagnostic errors. On a broad scale, how does the organization view the results and key recommendations of the report?
Gene N. Herbek, MD, FCAP: CAP is supportive of IOM’s efforts to study diagnostic errors, and we’re pleased with the findings and recommendations of the IOM report as they relate to pathology and laboratory medicine. The report addresses a number of issues that CAP has expressed concern about in its communications with policymakers, physicians, hospital administrators, and CAP members.
As pathologists, we know that making an accurate diagnosis is not easy. Doing so requires processes be correctly executed, for every patient, every time. We need to ensure that we have the right preanalytical data, the right specimens, the right methods of testing and analysis—and we expect the results of all these processes to be communicated to the patients themselves.
The IOM report emphasizes the patient’s need to be involved in reducing diagnostic errors. Patients need to be aware of what it takes to arrive at an accurate diagnosis.
We hope that the IOM report will help us to explain to other healthcare stakeholders—whether they are policymakers, physicians, administrators, or reporters—just how difficult it is to make a diagnosis. And for patients, we hope the report will help us to get the word out that they are central to all of our goals, and that we believe they have the right to an accurate diagnosis.
CLP: The IOM report defines diagnostic error from the point of view of the patient, who is the person most likely to be harmed if an error occurs. Did this perspective enable the committee to adequately identify and address all the sources of error that needed to be included in its report?
Herbek: The committee’s definition covers the waterfront, and it certainly touches the key sources of diagnostic error at a high level, but it probably doesn’t capture everything.
An interesting emphasis of the report is the notion that it’s essential not only to arrive at an accurate diagnosis, but to report that diagnosis in a timely manner to the right person. Failure to execute those steps is also considered a diagnostic error.
Another interesting issue pointed out by the report relates to the difficulties we have in managing the interoperability of our various information technology systems with patients’ electronic health records (EHRs). As an organization and as a specialty—including pathologists who are information specialists, informaticists, and even vendors in the field—we recognize there are many systems that can’t communicate with one another as easily as they should. This type of communication failure is also included under the report’s definition of potential diagnostic errors. If we could bring our vendors together and solve this one issue, it would be a huge step forward.
I work at Methodist Women’s Hospital in Omaha, a community hospital. A partner in our healthcare organization is the Nebraska Medical Center, the teaching hospital of the University of Nebraska. The IT system they use is different from the one we use. It is no minor expense or small effort to develop the middleware needed to get the two systems to talk with one another to ensure that the test results of both systems—whether they are in unstructured free text or structured discrete data—can be transmitted accurately.
Another strength of the report is its emphasis on the critical importance of diagnostic physicians, such as pathologists and radiologists, to arrive at an accurate diagnosis. As a sponsoring organization of the report, we agree with its direction and observations, which underscore the need for a collaborative approach to diagnostic medicine. The more we collaborate with the healthcare team, the more likely we will reduce diagnostic errors, and better serve our patients.
CLP: In spite of more than a decade of work by the Office of the National Coordinator for Health Information Technology (ONC), we still often hear about HIT-related privacy and security breaches, as well as diagnostic communications errors. In asking for the government to do more in this area, is the IOM report talking to the wind?
Herbek: We hope not. If policymakers and regulators create rules with enough teeth, and if they really focus on reducing errors, fixing this interoperability issue can be accomplished. We’re hopeful that this report will help stimulate and strengthen regulators’ resolve to bring the vendors together to help solve this problem.
As I understand it, the key obstacles center on the various information technology vendors’ concerns regarding intellectual property rights and proprietary processes, which is understandable. Most informaticists I know believe this problem can be solved without getting into issues of protecting the vendor’s software or intellectual property.
There have been many reports on this subject from ONC and others, and the IOM report reinforces their observations. The national system of health information technology is not where it needs to be to facilitate the exchange of accurate information. Let’s hope policymakers and regulators will do something about this problem.
CLP: Do you expect IOM’s recommendations will result in additional regulations or accreditation standards to ensure that laboratories implement interoperable communication systems?
Herbek: CAP’s accreditation checklist includes requirements for labs to demonstrate accuracy when they send out results to other physicians’ offices or hospitals, and that the end-user receives precisely what the lab sent them. CAP can impose requirements for communications within and among laboratories and their clients.
But the issues raised by the IOM report are quite a bit broader. To deal with the problems on that large scale, it will certainly be necessary for vendors to do whatever is necessary to reduce barriers and improve electronic communications. The solution can’t continue to be placed upon the users of such systems and software products, who regularly jump through many hoops to ensure their test results can be sent and received accurately, all in a timely manner. I’m hoping that the policymakers and regulators who are involved in this field can use the IOM report as further validation as to why we need to resolve this issue.
CLP: How do you see the IOM report influencing the training of the next generation of pathologists and other laboratory professionals, to ensure that they are attuned to the report’s recommendations?
Herbek: Pathologists in practice and in training all need to understand that formulating a diagnosis is a very complex, iterative process. Patients would benefit from understanding this process better than they do now. Having such a common understanding of what it takes to arrive at a correct diagnosis would be a big help in communicating diagnostic findings, and it’s something that pathologists will need to do.
Payers and policymakers frequently ask what proof exists that pathologists are contributing to improved patient care and outcomes. Our belief is that an accurate diagnosis—whether it arises from a laboratory test or a pathological examination of tissue specimens—is an absolute outcome. And having the capability to arrive at an accurate diagnosis comes only at the end of many other long processes: it requires a lot of education, a lot of quality control, a lot of documented confidence intervals, and so on. But in short, an accurate diagnosis should be considered an outcome in its own right. Such outcomes can and should be monitored.
That being said, we have to make sure that pathologists in training understand and work to implement the agenda for change that is outlined in the IOM report, which is in many respects similar to the ‘transformation’ initiatives that CAP has been undertaking and promoting for the past several years. CAP has been very active in identifying areas in which pathologists can bring about positive change for the healthcare system as a whole. But the college has now moved on to educating its members as to what they need to do to be successful in their practices and to advance the profession.
The need for collaboration is a key message of the IOM report, and it is directed not only at pathologists, but also at radiologists and others involved in the diagnostic wing of medicine. This is where all the tools we have are used to help other healthcare providers get to the right diagnosis. We don’t perform these tasks alone, and we need to have a lot of information to be successful—particularly in the areas of genetics and molecular medicine. Collaboration is a tool that we can embrace to help us become more precise in our diagnoses.
CAP agrees with and supports the premise and recommendation that diagnostic medicine is and should be a collaborative effort. This is a view that the college has been promoting by educating its members over the past several years. It’s an approach that our members and residents need to understand.
Collaboration should also extend to patients. We should make sure that our patients understand who we are and what we do. Although we feel this is important, we have a long way to go on this particular initiative.
I have had opportunities to show patients around our laboratory, and explain what we do. One patient who had been diagnosed with breast cancer was especially interested. I was able to show her the biopsies from her tumor, how tissue is processed, how the stained slides are examined under a microscope, and how we use information technology to generate a report. In the end, she commented that we ought to get this information out to everybody. The IOM report reinforces this view—that we need to show patients what we do and engage them more routinely than we do now.
But that’s easier said than done. Although my patient was interested, not all patients necessarily want to have such detailed information. And not all patients have the type of diagnosis that motivates them to understand more about their disease and diagnosis.
The IOM report’s emphasis on collaboration challenges us to ensure that our new residents and those who are interested in pursuing pathology understand that this is no longer a profession or specialty that can be performed entirely behind the scenes. Pathologists need to be up front and stand side-by-side with surgeons, oncologists, interns, family physicians, and nurse practitioners to work as a team. This is a message CAP has been emphasizing to its members.
CLP: In cooperation with medical specialty societies and professional associations, in vitro diagnostic manufacturers and other laboratory suppliers sometimes produce videos and other materials intended for use in educating or training laboratory professionals. Does the IOM report suggest a need for equivalent materials directed toward patients?
Herbek: Perhaps that is something we should be doing. In an area such as phlebotomy, for instance, it would be interesting to see how we could educate patients about this aspect of laboratory medicine. The next step, for example, might be to take viewers behind the scenes to see what happens with their blood sample.
Phlebotomy would be a good starting point because it’s the laboratory’s most common connection to patients. But such an educational effort should go beyond this starting point. It would certainly be interesting to get patient input and see how the initiative could be developed. A parallel series of materials, for instance, could be created to show what happens to a body fluid sample or a tissue sample.
Such an effort would also give us an opportunity to work with vendors, and to embrace them as partners. As a professional society, we are always aware of potential conflicts of interest when dealing with promotional materials. But these sorts of issues are of less concern when all of the participants are working to present an educational event or product to the public. Such an initiative would be a huge public service. It would go a long way toward addressing what the IOM report is trying to promote—that is, getting patients more engaged with healthcare professionals to improve and be a part of the quality of the end result, their diagnosis.
We probably should explore this possibility, and I don’t think we should be afraid to see how we could work together. In laboratories across the nation, pathologists work with many vendors who do great things. Patients would be absolutely fascinated to learn about the complexity, the high technology, and the professionalism we bring together to ensure accurate diagnostic testing.
CLP: The public is accustomed to seeing television portrayals of clinical or forensic laboratories, but those shows don’t typically do justice to the complex operations that go on in a laboratory.
Herbek: No, they don’t. We’re not glamorous, but a lot of what we do in areas such as blood banking, hematology, microbiology, and clinical chemistry is very interesting.
Biorepositories, for instance, provide the raw materials for research that affects many people. Patients should understand how they can help to advance medicine by donating to a biorepository, knowing that part of their tumor may be used to help clinical research. Similarly, there’s a lot of interest in testing for blood sugar in a variety of settings.
Hematology is a very visual area of pathology and laboratory medicine that patients would be fascinated to see. Starting with a blood sample drawn in a physician’s office or clinic, and following what happens to that sample—right up to the moment when the patient is told the results of the test—could be a very interesting story. There are many things that go on in the background—for instance, proficiency testing, quality assurance testing, and other operations—and a lot of tasks that have to be done correctly in order to produce an accurate laboratory report for even a single test.
As a sponsoring organization of the IOM report, CAP is especially happy with the emphasis of the report on improving laboratory medicine. CAP has been in the quality improvement business for 65 years, and in the business of setting standards for laboratory accreditation for 50 years. Promoting and improving laboratory medicine is CAP’s mission. That’s what we do, and we’re pleased to have the support of IOM’s report in these efforts.
CLP: You mentioned the importance of considering laboratory professionals as key collaborators and members of the healthcare team, which has not always been the case. As a result of the IOM report, do you expect that the professions of pathology and laboratory medicine will experience an increase in prestige and engagement with other healthcare professionals?
Herbek: This is one of the report’s recommendations, and I hope it comes to fruition. I’m very pleased that the report criticizes the fact that pathologists and radiologists are sometimes treated as ancillary or support services. To the contrary, the report recommends that we should be fully integrated members of the team. It emphasizes that pathologists and clinical laboratory scientists are an integral part of the healthcare team.
As a profession, we are certainly ready, willing, and able to take on this role. Some individuals may be more ready and willing than others, but this highlights the new challenge that confronts us. As a professional membership organization and as a profession, we need to ensure that all of our members and lab professionals understand and rise to meet this opportunity.
In my own institution and laboratory, we’ve been pursuing this approach for a long time. We are very active and visible in medical staff activities, tumor boards, and many committees. Our nurses, medical staff, and administrators have learned that they can ask us to do just about anything. We may have to say, “we’ll look into it”—and of course not everything is possible—but we always understand that we must be there to help our patients by working with other members of the medical staff, including primary care physicians and nurses in the hospital.
The recommendations of the IOM report lead in a very positive direction, and they validate many of the initiatives that CAP has been working on for the past several years. To improve our performance, we need to be prepared to step out from roles that might be considered merely ancillary support, and to perform as fully integrated members of the team. This is a significant observation and recommendation by the IOM report, which we intend to use when we educate not only our own members, but also policymakers and others in healthcare.
CLP: To improve on current practices, the IOM report recommends that institutions create a culture that enables their professionals to learn from diagnostic errors and near misses. But it could be tough for some institutions to accomplish such a goal. How do you see this being implemented in healthcare facilities across the nation?
Herbek: The report addresses this issue of transparency very well. Physicians and hospitals will need to become comfortable with saying, “we didn’t get this diagnosis right, and this is why.” The goal of such a process is not to blame anyone, but to understand how diagnostic errors occur. Arriving at a correct diagnosis is a very complex, iterative process, and some of our physician colleagues don’t appreciate how challenging it is..
This is also an opportunity for us to be transparent, and to help everyone—including patients and the public at large—understand what it takes to get to the right diagnosis.
Creating a culture of learning is challenging, and it takes time. Some patients are more interested and willing than others. Often, patients imagine that a pathologist can simply look at a slide and immediately determine a precise diagnosis.
Diagnosis of lymphoma is an example of diagnostic complexity. Years ago, lymphomas were categorized into just a few types. Now, there are dozens of lymphoma subclassifications, and each one has a significant impact on a patient’s treatment and prognosis.
CLP: The report also recommends that institutions adopt systems for voluntary reporting of diagnostic errors, possibly with the involvement of patient safety organizations, and it challenges policymakers to reduce the legal and financial liability of professionals who engage in postevent analysis of diagnostic errors and near misses. Is this likely to require legislation?
Herbek: This is a huge challenge, because healthcare environments can become highly litigious. When a malpractice event is alleged, physicians and other hospital staff can become very defensive, . Everyone begins looking at the episode and passing judgment on whether the decisions made were right or wrong, and this can easily lead to judgments regarding who is to blame and who is not to blame.
Implementing the IOM report’s recommendations in this area will require a lot of education, reeducation, and reassurance for almost everyone involved in patient care—including regulators, insurance companies, and especially patients. By educating patients about the diagnostic process, hopefully they will begin to understand that this is not a one-size-fits-all process, and that accurate diagnoses are not made easily. Treatment-related complications that physicians discuss with their patients do occur—regardless of whether the patient heard or understood the information.
CAP has a policy on what to do when there’s a significant diagnostic error. The first step is to identify the error, and then work with the ordering physician and other healthcare providers to make sure the error is acknowledged and understood. After that, the recommendation is to ensure there is a meeting with the patient and their family to help them understand what happened. We believe this policy supports the steps necessary when a diagnostic error has been made, and it directs and encourages healthcare professionals to follow the policy as much as a professional membership organization is able to do.
CLP: The report also challenges payors to come up with a system that acknowledges the importance of both professional and patient consultation by pathologists and laboratory professionals, and pays them appropriately for their service. That recommendation must be one that CAP is very happy to see in the report.
Herbek: This is not a new issue for us. Over the past several years, we have been discussing with the Centers for Medicare and Medicaid Services (CMS) the impediments that prevent pathologists from providing consultation when they feel it is necessary. The purpose of such consultations would be to offer recommendations on further testing, what testing not to do, what molecular tests might be useful, and so on.
The current process presents an obstacle for the pathologist to provide and be compensated for a consultation because another physician has to order the consultation. As medical professionals, we believe we have the ability to discern when a consultation is needed. From our perspective, it would be better for pathologists to document the rationale for a consultation, and provide the necessary recommendations, without requiring an order from an attending physician.
We hope that the IOM report will help to reopen those discussions. It is certainly worthy to note that such a distinguished, influential, and powerful group acknowledges the value of independent consultation by pathologists and laboratory professionals. We hope that CMS will agree to reconsider its position and permit pathology consultations when they are warranted.
Obviously, CMS is concerned about overutilization and abuse of pathologist-driven consultations if given a current procedural terminology (CPT) code. I’m sure we could develop a system that would enable physicians to validate the rationale for a pathology consultation, and to document the fact that the consultation was relevant and effective. If a pathology consultation doesn’t meet requirements, CMS can always decline to provide reimbursement, or even initiate disciplinary action for those who abuse the system.
CMS’s position echoes its longstanding emphasis on the need to demonstrate the value of cognitive medicine versus procedure-oriented medicine. The agency is not only concerned with the value of pathology consultations, but also with the value of consultations by other physicians in cognitive medicine. In all of these instances, CMS is placing emphasis on the need to demonstrate real value to practitioners and patients.
We support demonstrating and recognizing the value of pathology and other diagnostic services for patients. The IOM report supports the value of pathology consultation—a view that we can use in discussions with both CMS and other third-party payers. This will enable us to demonstrate the value we bring to the medical staff, and to emphasize that diagnostic medicine is not a mere commodity. Pathology is not an ancillary service. And pathologists should be regarded as physician members of the patient’s diagnostic team.
CLP: The final recommendation of the report is to fund a coordinated research agenda on diagnostic error by the end of 2016. The committee calls for public-private collaboration to get that agenda moving. What entities are likely to be involved in coordinating such an agenda, and how do you see it coming to fruition?
Herbek: Obviously, federal agencies will be involved: the Department of Health and Human Services and its various agencies, the Department of Veterans Affairs, and possibly the Department of Defense. But I would also expect the American Medical Association (AMA) to be a partner—representing many medical specialty societies—as well as the American College of Radiology and other professional associations mentioned in the IOM report.
I’d like to think those partnerships would also include organizations representing diagnosticians—pathologists and radiologists—as well as professionals from those fields who are involved in research and public health agencies.
The call for public-private partnerships is interesting. I’m not sure what organizations might fulfill that objective, but those roles might be filled by large integrated health systems or by philanthropic organizations that are involved with healthcare, patient safety, diagnostic information technologies, or similar concerns. Professional liability insurers could also become involved, particularly if the research agenda is going to look at how improved diagnostic accuracy and communications can help reduce lawsuits.
CLP: As a means of reducing error, the report is very emphatic about improving the adoption and use of health information technologies. Does the report also suggest opportunities for other types of technology contributions that may help to reduce or eliminate diagnostic error?
Herbek: Any technology that would reduce the chance of human error, facilitate patient identification, improve the speed and accuracy of testing, or promote better reporting of test results could certainly play a role. Barcoding systems used to identify patients and track patient specimens, for instance, would be a type of technology that helps to reduce diagnostic error.
CLP: How would you sum up CAP’s sentiment with regard to the IOM report?
Herbek: As an organization and as a profession, we agree with the observations of the IOM report with regard to pathology and laboratory medicine, and we support the report’s recommendations. There are details that need to be worked out, but by and large this is a report that we feel we can build upon. Using this IOM report as a springboard, and working together with other organizations, we believe we will be able to accomplish a number of objectives that we’ve been trying to achieve for some time—and in some cases, for decades.
CAP is an organization whose mission is to support excellence in pathology and laboratory medicine. We feel this report will help us accomplish our mission.
Steve Halasey is chief editor of CLP.
- National Academy of Sciences. To err is human: building a safer health system. Kohn LT, Corrigan JM, Donaldson MS, eds. Washington, DC: The National Academy Press, 2000.
- National Academies of Sciences, Engineering, and Medicine. Improving diagnosis in healthcare. Balogh EP, Miller BT, Ball JR, eds. Washington, DC: The National Academies Press, 2015.