Enhancing Dermatopathologic Precision: Submitting Clinical Photographs with Biopsies Should Become Standard of Care in Difficult-to-Diagnose Cases
The “Standard of Care” is a legal term of art that refers to the degree of care a prudent and reasonable person would exercise under the same or similar circumstances. While different states, agencies, and courts may define the standard somewhat differently, most states follow a national standard similar to the one from Connecticut Code §52-184c: “…that level of care, skill and treatment which, in light of all relevant surrounding circumstances, is recognized as acceptable and appropriate by reasonably prudent similar health care providers.”1 In torts law, breach of the standard of care is one of the four elements of negligence along with duty, causation (both actual and proximate), and damages. Negligence is harm caused when a person fails to exercise appropriate care.
The standard of care that a person is expected to exercise varies and is lower for a general citizen than it is for someone with specialized training. A health care professional is expected to exercise the level and type of care that a reasonably competent and skilled health care professional with a similar background in the same medical community would be expected to provide under the same or similar circumstances. A specialist is held to a higher standard and is expected to exercise the same degree of care that a reasonably competent specialist with similar training and experience would use under the same or similar circumstances. There are often national standards that are applicable to specialists such that simply how other specialists perform in communities is often not sufficient to lower the standard of care expected to be exercised by a specialist.1 In spite of this, the applicable standard of care is often subjective and alleged breaches are often subject to arguments by both plaintiff and defendant expert witnesses.
DETERMINATION OF NEGLIGENCE
When there is alleged negligence in a malpractice claim, the burden of proof to meet the four elements of negligence lies with the plaintiff and must be demonstrated by a preponderance of the evidence standard. A legal balancing test was developed decades ago by the late Learned Hand, a former federal judge in New York. The Hand test states that a defendant’s conduct is unreasonable if the burden to mitigate risk is lower than the product of the gravity of the potential loss and the probability of harm to the plaintiff resulting from the defendant’s conduct. The failure to mitigate this risk is evaluated in the context of the elements of negligence and whether it constituted a breach of the standard of care that caused harm to the plaintiff that was substantial enough to file a claim. These variables are assessed with respect to socioeconomic factors and can change over time.
As an example, the burden to mitigate a risk might be onerous at one point in time, yet may have become much less difficult over time, such as installing seat belts and airbags in automobiles, which is now routine. Similar circumstances exist in a medical context such as a surgical procedure which may have been impracticable years ago that may be performed safely and routinely today. The failure of an automobile manufacturer to install safety devices or a surgeon to fail to perform a lifesaving procedure, such as an appendectomy, would be unreasonable and possibly be negligent today where it may not have been expected or even possible in times past.
CHANGING STANDARDS OF CARE FOR DERMATOLOGISTS
Just as in other specialties, the standard of care in dermatology has changed over time. We now have safe, highly efficacious medications for treating many serious disorders, such as melanoma, for which there were previously no effective treatments. There are also surgical procedures for serious skin malignancies that can be curative that were not available before. A dermatologist failing to offer these treatments to a patient can be viewed as unreasonable behavior, as the burden to offer them is quite low, yet the potential for harm and its probability can be quite high. Dermatologists understand these scenarios quite well today, and no reasonable dermatologist would fail to follow this standard.
A prevalent but less recognized issue exists in the diagnostic context and arises when a biopsy specimen is submitted for dermatopathology interpretation with incomplete or inaccurate clinical information. This often leads to an inaccurate diagnosis, which can then result in inappropriate treatment. This problem has been exacerbated with the advent of electronic medical records that have “canned” menus of descriptions of skin disorders that are selected by the individual completing the pathology requisition form—who is often not the individual performing the skin biopsy but rather a medical assistant or clerk. Some of these descriptions are extremely generic and virtually worthless to a dermatopathologist when attempting to perform clinicopathologic correlation, such as “neoplasm of uncertain behavior” or “rash unspecified.” Others include classic textbook descriptions of a disorder such as psoriasis that a dermatologist would rarely biopsy if those findings were clinically obvious. Still others include descriptions of all pigmented lesions with terms that suggest melanoma without further description such as diameter, asymmetry, etc.
Because clinicopathologic correlation is essential for rendering accurate histologic diagnoses in many cases, this failure to provide reliable information can potentially lead to patient harm, which may result in claims of negligence. Given that the burden to provide reasonably detailed information is low, the probability of causing patient harm is relatively high, and the harm that can result from a failure to diagnose a condition can be significant, failure to provide information meets the criteria of the Hand test for negligence and could lead to a malpractice claim.
Over the last two decades, with the advent of digital photography, clinical photography in dermatology has become routine; many, if not most, dermatology practices now take photographs of virtually all patients, including skin lesions prior to biopsy. Many studies have been undertaken that show the accuracy of diagnoses improves significantly when patients are evaluated at conferences or clinical photographs are examined in the context of skin biopsies.2,3 Because dermatologists have an ethical obligation to provide the best care possible for their patients, because providing reliable and reasonably complete information to the pathologist about a patient when submitting a biopsy is important, because taking digital photographs and providing access to them to the interpreting pathologist is relatively easy, and because the pathologist having access to digital images can improve diagnostic accuracy and patient care, providing access to digital photographs of dermatology patients should now become routine and standard of care in appropriate cases.
LIMITATIONS AND FUTURE CONSIDERATIONS
Pathologist evaluation of clinical images is not necessary in every case and certainly not for every lesion that is biopsied. Most routine basal cell carcinomas, nevi, cysts, and other commonly encountered lesions are straightforward and can be made readily by histologic examination alone. However, complex inflammatory skin diseases, atypical pigmented lesions, especially pigmented lesions of the nail unit, and other scenarios can be diagnosed with greater accuracy when clinical images are evaluated with histologic features. A high-quality clinical image is far superior to a poorly crafted description or something chosen from a “menu” of generic options. Furthermore, the images should be made available before or at the time of the biopsy, not after, to avoid the pathologist having to issue amended reports. Obviously, if clinical images are of poor quality, they will be of limited use. However, digital cameras, even on smartphones, can generate high-quality images that can be easily shared with the pathologist.
Because this will likely become a new standard of care that dermatologists will be expected to exercise, they will need to understand the importance of taking high-quality images and how to share them in ways that do not violate privacy standards. Because dermatopathologists will be expected to be able to evaluate clinical images of patients and correlate them with histologic features, they must have the ability to perform clinicopathologic correlation well.
For attorneys considering whether failure to provide digital images has led to patient harm, they will need to understand when the clinician should have provided them and when it is reasonable for them not to do so.
As with any change in standards and new developments, the best approach would be development of non-legally binding guidelines that can assist clinicians in how to incorporate this into their practice routinely. A recent retrospective review at a tertiary care academic center revealed that there has been an increasing number of more complex dermatopathology cases, which was defined as those requiring rush processing, consensus agreement, use of immunohistochemistry or immunofluorescence, performance of special histochemical stains, examination of additional tissue levels, review of a prior case, addition of an explanatory note, presence of numerous specimen parts, or use of intradepartmental consultation.4 With the clinical images provided as described above, diagnoses can be made more readily with clinicopathologic correlation alone, lessening the utilization of additional tests and decreasing costs.
CONCLUSION
With the advent of the internet and electronic health records, it has become easier to create high-quality clinical images and make them available to others, such as consultants and pathologists, improving patient care by enhancing clinicopathologic correlation. It offers the potential to decrease the number of unnecessary tests, to lessen medico-legal liability, and to decrease healthcare costs. Providing access to clinical photographs in difficult-to-diagnose or ambiguous cases should become a component of the standard of care for dermatology, as it will benefit patients, clinicians, dermatopathologists, and society overall.
Dr. Cockerell reports no financial disclosures.
Kaycee Nguyen BS, is a medical student at Texas A&M School of Medicine, Dallas. Clay J. Cockerell, MD, MBA, JD is the owner of Cockerell Dermatopathology in Dallas. He is also affiliated with the Lake Granbury Medical Center and the Departments of Dermatology and Pathology at UT Southwestern Medical Center, both in Dallas.
1. Vanderpool D. The Standard of Care. Innov Clin Neurosci. Jul-Sep 2021;18(7-9):50-51.
2. Hadi R, Miller TI, May C, et al. Impact of clinical photographs on the accuracy and confidence in the histopathological diagnosis of mycosis fungoides. J Cutan Pathol. Jul 2021;48(7):842-846. Doi:10.1111/cup.13938
3. Cerroni L, Argenyi Z, Cerio R, et al. Influence of evaluation of clinical pictures on the histopathologic diagnosis of inflammatory skin disorders. J Am Academ Dermatol. 2010/10/01/ 2010;63(4):647-652. Doi:https://doi.org/10.1016/j.jaad.2009.09.009
4. Stagner AM, Tahan SR, Nazarian RM. Changing Trends in Dermatopathology Case Complexity: A 9-Year Academic Center Experience. Arch Pathol Lab Med. 2020;145(9):1144-1147. Doi:10.5858/arpa.2020-0458-OA
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