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Reducing Malpractice Risk in Pathology

With every diagnosis comes risk. Is this the correct diagnosis? Did I rule out other possibilities? Were the appropriate sections taken? These are just some of the questions that run through the mind of the pathologist when reading surgical pathology cases.

One important lesson I have learned when reviewing medicolegal cases as an expert witness is the determination of whether the standard of care was met. What is the standard of care? Standard of care is a legal term that is actually quite complex, but in essence, just refers to how the average pathologist would have managed the patient under similar circumstances.1

Risk in Pathology

It is not surprising that pathologists are at greater risk than other specialties in being named to a malpractice suit2. Additionally, pathologists are at higher risk for an adverse outcome at trial.3

Perhaps in no other field is there as much grey zone diagnoses and subjective interpretations as pathology. Even experts disagree on controversial diagnoses. Since all treatment begins with a diagnosis, the consequences are high with an alleged misdiagnosis.

There is value in recognizing where risk exists in surgical pathology and how best to manage it. This helps to avoid being named in a malpractice suit, or if named, it may minimize one’s risk of an unfavorable outcome at trial.

Importance of the Pathology Report

It has long been recognized that communication is key to decreasing medicolegal risk. For pathologists, despite a movement towards a more forward-facing model, the surgical pathology report still is the primary form of communication with the submitting provider.

A quality pathology report is the pathologist’s best defense when a claim arises. Litigation often takes years, and it may be difficult to remember specific details of a case. A well-written report that clearly states the actions of a qualified and thoughtful pathologist is much easier to defend, even with an alleged misdiagnosis. A checklist is often helpful to go through before signing out a case.

Troxel offers the following guidelines when writing the pathology report:4,5

  • Define difficult to understand pathology terms.
  • Provide a detailed microscopic description for difficult or unusual cases.
  • Discuss the differential diagnosis in the report.
  • Document recommendations for additional testing or treatment.
  • Issue written reports documenting verbal consultations when you review a slide and offer an opinion.
  • Always include clinical information in the history section of the report, or document that none exists.
  • If issuing a provisional diagnosis, clearly state this, and that a final diagnosis will be reported upon results of further studies and/or expert consultation.
  • Issue an addendum whenever important new information is received.
  • Document intradepartmental consultations.
  • Document and date all communication with clinicians in the report, and in particular, all critical/significant/unexpected diagnoses.
  • Review the report before its release to detect any transcription errors.

Claims Data

Reasons for claims against pathologists have changed over recent years. Troxel found in an analysis of 378 pathology malpractice claims from 1998 to 2003 that a false negative diagnosis of melanoma was the most common reason for pathology malpractice claims.6 Common misdiagnoses for melanoma included Spitz nevus, ‘dysplastic’ nevus, spindle cell squamous carcinoma, atypical fibroxanthoma, and dermatofibroma. Breast biopsy claims were second to melanoma. However, when combined with breast FNA and frozen section claims, these were the most common cause of pathology malpractice claims. Cervical Pap smears were third in frequency, with nearly all involving a false negative interpretation. Among surgical pathology claims, misdiagnosed ovarian tumors were common. Systems errors also accounted for a significant number of claims, especially those of breast or prostate needle biopsy specimen mix-ups.

Kornstein and Byrne found in a search of 171 legal cases involving pathology from 1998 to 2005 almost half involved surgical pathology with cytology and clinical pathology accounting for the remainder.7 Like Troxel, they found the misdiagnosis of melanoma as the leading reason for pathology related malpractice claims. Breast biopsy and gynecology specimens were next in prevalence for surgical pathology. The majority of cytology cases consisted of false negative cervical Pap smears. Most cases involving clinical pathology related to the blood bank and transfusion-associated HIV infection. Pathologists will be interested to know that a failure in critical value reporting was also listed as a reason for a malpractice claim.

In a later study, Troxel found in 276 malpractice claims from 2004 to 2010 that there was a significant decline in the number of claims involving melanoma, breast, and gynecologic cytology.4 Troxel speculates the decrease in melanoma claims is a consequence of increased emphasis in recent years of melanoma education in continuing medical education courses. Additionally, the trend towards larger pathology groups has allowed for greater subspecialty depth increasing the likelihood a group will employ a dermatopathologist.

Troxel credits similar factors leading to the decrease in breast biopsy claims, stating a “greater emphasis in the literature and in CME programs on directed needle biopsy interpretation, greater experience with this diagnostic technique, increased use of standardized protocols and diagnostic algorithms, and the decreased use of breast frozen section.”4

Again, the shift towards larger pathology groups is credited with the decrease in pap smear claims. Larger groups are more likely to hire a cytopathologist. The increased use of liquid-based technology is also cited as a contributing factor. Increased adherence to consensus guidelines, proficiency testing, cytology CME courses and regulatory oversight has addressed cytology related system-based errors.

System errors, which include post-analytic errors such as transcription errors and reports or diagnoses not called to or received by the clinician, appear to be increasing in prevalence.

Conclusion

There is a lack of recent publications on pathology claims, so it would of interest to determine if reasons for claims are changing further. In the interim, the pathologist will serve themselves well by recognizing risk, where it exists and how best to manage it. These are key to decreasing medicolegal risk.

Remember these simple steps. Go through a checklist, and most importantly, prepare a well-written pathology report. Review your report before signing it out. Was the standard of care met?

References

  1. Allen, TC. Medicolegal Issues in Pathology. Arch Pathol Lab Med. 2008;132:186–191.
  2. Jena AB, Chandra A, Lakdawalla D, et al. Outcomes of Medical Malpractice Litigation Against US Physicians, Arch Intern Med. 2012;172:892-894.
  3. Dark Daily, Medical Malpractice Study Reveals that Pathologists Are at Greater Risk than Other Specialists for Claims and Lawsuits, Aug 22, 2012, accessed 8/7/18.
  4. Troxel DB. Trends in Pathology Malpractice Claims, Am J Surg Path. 2012;36:e1-e5.
  5. Troxel DB. The Pathology Report: Reducing Malpractice Risk. The Doctors Company, accessed 8/7/18 at thedoctors.com.
  6. Troxel, DB. Medicolegal Aspects of Error in Pathology. Arch Pathol Lab Med. 2006;130:617–619.
  7. Kornstein MJ, Byrne SP. The Medicolegal Aspect of Error in Pathology: A Search of Jury Verdicts and Settlements. Arch Pathol Lab Med. 2007;131:615–618.

Michael J. Misialek, MD, FCAP
Michael J. Misialek, MD, FCAP, is associate chair of pathology at Newton-Wellesley Hospital in Newton, Massachusetts. Dr. Misialek is a strong advocate for the recognition of pathologists in patient care and an early adopter of patient consults.

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