​ Cover story two

Diagnostic accuracy

A dose of insight

By Robert Hanscom, JD; Maryann Small, MBA; and Ann Lambrecht, RN, BSN, JD, FASHRM

early 84% of adults and 93% of children will have contact with a health care professional each year in the United States. (See https://tinyurl.com/mp-stats.) These patients and their caregivers are ultimately asking for two things—an accurate diagnosis and an appropriate treatment plan. While arriving at a timely and accurate diagnosis for every single patient may not always be possible, it is always the goal.

Diagnostic accuracy is far from simple. In fact, diagnosis-related events are the single largest root cause of malpractice claims. Health care providers can benefit from fresh perspectives, data-driven insights, and new ways of thinking about everyday activities.

A fresh approach to claims data

Our conclusions from analysis of claims data are not absolute findings, but hypotheses: signals from the past about where vulnerabilities existed and may still be at play.

Typically, a fully investigated liability claim will contain valuable information, such as allegations of primary and secondary causes, patient health and demographic information, injury severity, physician specialty, risk management issues, location of the alleged error, human and financial costs, and expert reviews and opinions. We use this information to create evidence-based recommendations to mitigate risk.

Leading causes of claims

Diagnosis-related events result in indemnity payments just slightly higher than the next five highest categories combined. Our study found that 53% of diagnosis-related claims include risk management issues involving poor clinical decision-making; 54% are high-severity cases, with 36% resulting in death; and 36% stem from outpatient (office setting) locations.

Rethinking the diagnostic process

It’s estimated that 10–20% of all medical diagnoses are inaccurate (see https://tinyurl.com/mp-accuracy). Thirty-three percent of diagnostic-related claims and 26% of associated indemnity payments allege that a breakdown in decision-making occurred during the patient’s H&P (patient/family history and physical examination).

Recommendations:

• Develop a policy that requires obtaining and documenting specific elements of the H&P.
• Implement and use a template to serve as a checklist when performing the physical examination.
• Establish a routine for updating family history regularly. Include reminders and prompts in the electronic health record (EHR).

Diagnostic/lab testing

The four discrete phases of testing (ordering, performance, receipt/transmittal, and interpretation) trigger 52% of diagnosis-related claims and 55% of indemnity payments.

Recommendations:

• Provide decision support tools to assist providers in ordering proper diagnostic tests.
• Implement a protocol to obtain and document patient specimens.
• Implement a process for patients to obtain outstanding test results, as well as contact information to follow up.

​It’s estimated that 10–20% of all medical diagnoses are inaccurate.

Referral management

Nine percent of the diagnosis-related claims we examined were attributed to referral management.

Recommendations:

• Develop a consultation policy that includes criteria for a provider to consider when deciding whether and when to obtain a consultation, and when a consultant must directly manage the patient. Hardwire this policy into the EHR.
• Develop and embed into the physicians’ workflow processes for all transitions which require communication and documentation of specific patient status information and medications.
• Implement a chain-of-command policy that outlines the process to escalate patient treatment differences to an ultimate decision-maker. Train and reward for adherence.
• Develop a follow-up process for patients who have been referred to a specialist, including patient contact and follow-up appointments.

Physician follow-up

Allegations involving inadequate physician follow-up with the patient accounted for 5% of claims and 7% of indemnity paid.

Recommendations:

• Provide the patient with written instructions that describe the diagnosis, expected results, side effects, or new symptoms that could arise and require attention; whom to contact with concerns; and suggested follow-up care.
• Ensure that the patient’s primary care provider receives a copy of all patient instructions, as well as test results and information on follow-up appointments.
• Consider various communication methods, such as secure online patient portals, email, and a designated telephone line.
• Develop a call-back system for patients with certain high-risk presentations to determine whether symptoms have subsided and that instructions have been followed.
• Engage the patient. Assign them the job of reporting back key symptoms.

Missed and delayed diagnosis of cancer

Among malpractice claims that allege a diagnostic failure, the largest number involve a missed or delayed diagnosis of cancer. The top four cancers involved in such claims have always been breast, lung, colorectal, and prostate, though the exact order periodically shuffles.

In the case of breast and lung cancers:

• The majority of claims alleging diagnostic failure were filed against radiology practitioners.
• The leading clinical judgment issue was misinterpretation of diagnostic studies (47% of lung cancer claims and 44% of breast cancer claims). We believe that poorly written diagnostic/radiology reports are a major contributing factor.

In the case of colorectal, lung, prostate, and oral cancers:

General medicine practitioners are the focus of most allegations involving these cancers. They are pulled into these cases largely because of their role as the overall manager of the patient’s care.

In 2016, the highest number of new cancer cases among men were cancers of the prostate, lung and bronchus, and colon and rectum, while the largest number of new cancers in women were cancers of the breast, lung and bronchus, and colon and rectum—the exact top four cancers involved in allegations of diagnosis-related failure, and the same cancers that are on the rise in the United States (see https://tinyurl.com/mp-cancer-stats).

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The role of radiology in cancer diagnosis

More than half of diagnosis-related claims involve an allegation that something went wrong during one of the testing steps, specifically diagnoses involving radiology and the presence of cancer. The vast majority of breast- and lung- cancer claims allege that the radiologist was the specialist most accountable.

Quality improvement processes that provide honest feedback to radiologists on the accuracy of their reads may not be as robust as they ought to be, which may lead radiologists to conclude their accuracy rate is higher than it is. Also, when radiologists are unsure of their interpretation, there may not be decision support tools in place or an avenue to obtain a second opinion without embarrassment or retribution. Further, ongoing education on common and unusual diagnostic pitfalls may be lacking.

Teleradiology provides a valuable service for facilities that cannot support an in-house radiologist around the clock, but it can also contribute to missed diagnoses if film and transmission quality are suboptimal.

Sometimes a sound diagnosis and an optimal outcome comes down to the writing and communication skills of the radiologist and/or the ability of the ordering provider to interpret information. Radiology reports that contain many possibilities but no definitive diagnostic information can be confusing, and do not aid in developing a care plan. This problem is further compounded when the report includes disclaimers and multiple recommendations without a sound basis to implement them.

Recommendations:

• Revisit peer review practices to ensure that they include how to measure and communicate periodic evaluation of clinical outcomes and compliance with established quality indicators and when performance may warrant closer review.
• Implement ongoing over-read or second-evaluation processes, with feedback to radiologists.
• Provide decision support tools.
• Develop criteria for when a second read of a film must be performed and the stated time frame for completion.
• If teleradiology is practiced, conduct regular testing for film and transmission quality.
• Develop standardized report templates that require specific elements, such as suspected and ruled-out conditions, as well as the probable diagnosis and recommendations. Include a summary of findings at the beginning.
• Forbid disclaimers or language such as “dictated but not read.”

Diagnostic accuracy: cardiac and vascular issues

Cardiac and vascular issues represent 8% of diagnosis-related claims. Taken together, heart problem (non-MI), myocardial infarction (MI), and thrombosis/clot/emboli were involved in 12% of diagnosis-related claims. These issues were almost as frequent (12% vs.13%) in our study as infections (pneumonia, sepsis, MRSA, sinusitis, etc.) and were more frequent than fractures/dislocations (a historically common condition in diagnosis-related claims).

Heart and vascular issues can be difficult to diagnose because symptoms can vary from patient to patient and can mimic symptoms for other common ailments. Because these issues are so often fatal, it’s important that diagnostic testing be thorough and timely and that practitioners obtain a complete patient and family history.

Helping physicians and patients to do better, together

Below are important questions to consider in helping physicians and patients work together in the quest for diagnostic accuracy.

• How might we re-engineer the diagnostic culture to calibrate confidence and accuracy? In most practices and hospitals, there is no standardized or safe way to document a provider’s degree of uncertainty.
• What kind of structures, consultation practices, and processes could be put in place for cases in which there is a high degree of diagnostic uncertainty?
• How can we improve communication between and among medical teams, especially the lab, radiology, and the provider who will make the ultimate differential diagnosis?

​Arriving at a timely and accurate diagnosis for every single patient may not always be possible.

Inpatient vs. outpatient settings

Our claims data show that 35% of diagnostic errors occur in physician offices and clinics. It is difficult to determine the exact cause(s) for this finding. It could be that, unlike hospitals, office settings often do not have personnel dedicated to auditing compliance with published practice guidelines. Even if physician offices do review this information, the volume of data may not be large enough to be considered a credible basis for treatment decisions.

In addition, peer review may not be as robust in a small practice. All the providers may be similarly trained and approach diagnoses the same way; every provider in the practice may not feel comfortable offering alternatives to another provider; and there are typically no expert resources within an office practice that can provide guidance.

Finally, the practice may not have access to clinical decision support tools that can assist in diagnosing and developing the appropriate treatment during the first patient encounter.

Recommendations:

• Explore available clinical decision support tools and use claims data to justify investing in one or more of these tools.
• Obtain national, state, and regional statistics on practice guidelines regarding the diagnoses treated within the clinic or practice.
• Collect and compare clinic or practice data and clinical outcomes with the data obtained.
• Ask local hospitals if they can provide data and expert resources to review certain types of cases and outcomes.
• If specific populations are treated, identify barriers to medical regimen adherence and explore opportunities within the community to address barriers.

The emergency department and its role in diagnostic risk

The emergency department (ED) and urgent care facilities, as a category, represent the location type with the second-highest incidence of diagnostic-related claims (24% of claims and 17% of indemnity paid).

These physicians typically have no ongoing relationship with most patients, some of whom arrive unable to speak for themselves and with no reliable historian accompanying them. ED providers have to make immediate and often lifesaving decisions with little or no information, often with rapid and impersonal patient hand-offs.

About 48% of diagnostic-related ED closed claims included allegations of patient evaluation, followed by 26% that alleged issues with ordering tests. More than 50% of diagnostic-related ED claims showed the highest level of severity, a category that includes death. Key risk management issues in order of priority involved clinical decision-making (53%), clinical systems (13%), and communication (8%).

Recommendations:

• Ensure patient evaluation occurs on an ongoing basis during the ED or urgent care episode by requiring documentation of patient status at prescribed intervals.
• Implement clinical decision support tools to assist in the diagnostic process, such as practice guidelines for high-risk presentations, clinical decision applications, and a dedicated radiologist and pharmacist to assist with diagnosis and treatment.
• Implement a chain-of-command policy to address situations in which there is a difference of opinion on treatment. Embed that policy into the workflow.
• Provide patients with written discharge instructions in layman’s terms that include the diagnosis, treatment provided, symptoms that require action and which actions to take, referral information, medications, and other pertinent information.
• Develop a protocol to communicate outstanding test results to the patient, primary care provider, and consultants.

Health insurance companies and their impact on diagnosis

Our insured providers continue to express concern over health insurers’ approval processes for tests and procedures. They report that the approvals are not consistent, often delay the diagnostic process, and, at times, appear arbitrary. Most practitioners do not quarrel with national practice guidelines for a particular diagnosis if they are supported by credible data, but are frustrated by approvals that require several interim steps that can add complexity and confusion.

Recommendations:

• Document the patient’s medical record thoroughly regarding discussions, recommendations (include the basis for them and any supporting data or studies), and risks associated with other alternatives.
• Scan copies of insurance company denials into the patient medical record and advise the patient to contact the insurance company directly. As the consumer, they may have more influence.
• Provide the patient with the option to obtain the test or procedure at their own cost and document the conversation.
• Track repeated denials for the same request. Ask for an evidence-based rationale. Send any evidence you have that supports approving the test or procedure that was denied.

​Final recommendations

The following recommendations apply broadly to the phenomena of diagnostic errors:

• Honestly examine diagnostic culture and other influences that create overconfidence in medical diagnoses.
• Document any uncertainty in the EHR to alert other team members that the final diagnosis is evolving. This could potentially prevent subsequent providers from becoming anchored in a diagnosis that is less than certain.
• Include the patient in the decision-making that leads to a differential diagnosis. Position your assessment as a “working diagnosis” and encourage them to actively examine test results and other information. When something does go wrong, a patient who feels cared for, engaged, and honestly communicated with is less likely to pursue litigation.
• Keep your location in mind. Reaching an accurate and timely differential diagnosis in the emergency department may require different processes, skills, and talents than doing so in an outpatient setting.
• Use available technology and decision-support tools.
• Be conscious of all that is working against you. There are financial incentives for not continuing to look for the right diagnosis—the hunt can be expensive and arduous. And patients are prone to diagnosis fatigue and can eventually give up, accepting their health challenges as their “new normal.” Encourage patients to come back if they aren’t getting better, to ask more questions, and to share more details and hunches about their symptoms.

Conclusion

The magnitude of responsibility for diagnosis is staggering, and the issue of diagnostic inaccuracy is no small matter. Diagnostic inaccuracies may have grave results, but it’s important to acknowledge that doctors are getting it right more often than not.

This article includes general risk management guidelines for information purposes. It is not intended, and should not be taken, as legal or medical advice.

Robert Hanscom, JD, is vice president of business analytics at Coverys.

Maryann Small, MBA, is director of data governance and business analytics at Coverys.

Ann Lambrecht, RN, BSN, JD, FASHRM, is senior risk specialist at Coverys. 

Publisher’s note: This article is an excerpt from a Coverys report. Unless otherwise indicated, statistics and information are based on Coverys’ analysis of 10,168 closed malpractice claims across a five-year period (2013-2017). A more full report on diagnostic accuracy from the authors, with extensive supporting data, is at https://tinyurl.com/mp-coverys.