Abstract
Editor:
Because this letter is about professionalism and professional standards, let me begin by providing a short history to explain what has led me to address the membership with some concerns.
Recently, toxicologic pathologists found it necessary to again1 defend their professional practices when statisticians at the Food and Drug Administration (FDA), Center for Veterinary Medicine, reminded sponsors that all histopathology evaluations must be conducted in a “blinded” manner on studies submitted to the Center. Mistakenly, the Center believed “blinded” pathology evaluations would improve the quality of the pathology the Center received. Unfortunately, “blinding” has exactly the opposite effect on quality. Currently, the Center will accept and approve New Drug Applications that lack an interpretive pathology report and thus are without explanation of the severity grading scales assigned to lesions. Such information is necessary for medical opinions to be formed about the pathology data and hence the safety of the drug or device. The Center also permits persons without professional degrees (DVM or MD) and without board certification in pathology to evaluate pathology on safety studies submitted to the FDA. All of these issues are most disturbing.
As we all know, acceptance into veterinary school and success in the Pathology Board Examination requires intelligence, hard work, and personal sacrifices. Veterinary pathologists have high professional standards. We should guard these standards zealously.
Histopathology slide evaluations must be performed by a pathologist. The pathologist is responsible for identification and interpretation of tissue abnormalities, and provision of medical diagnoses. Further, necropsies and tissue processing also must be performed or closely supervised by a pathologist. This insures that gross lesions are recognized, captured, and named correctly and the tissues are properly processed, all in order to arrive at a correct medical diagnosis. To perform such duties, which affect the safety of both humans and animals, the pathologist must have the appropriate training and experience. (A pathology evaluation is not simply pattern-matching.) Further, the pathologist must be able to demonstrate that she or he has gained the required depth and breadth of knowledge to render the correct medical diagnosis. Evidence of passing examination grades at a recognized university in the essential components necessary to render a medical diagnosis (anatomy, physiology, biochemistry, pharmacology, histology, bacteriology, parasitology, mycology, virology, medicine, surgery, and pathology) is required. These prerequisites define a pathologist's basic scope of knowledge. Additional training or experience relevant to species (rodent pathology), disease (encephalopathies), or anatomical location of the lesion (immunopathology) or further study in the general area of pathology usually is under-taken by the pathologist. Specifically, the American College of Veterinary Pathologists (ACVP) and the American College of Pathology recognize the excellence of pathologists who have undertaken a more intensive study of pathology and who have passed the respective certification examinations.
Members of the College of American Pathologists2 have defined themselves and their specialty as follows.
Pathologist: A specialist who is a physician who voluntarily undertook and successfully completed an approved graduate medical education program in pathology and an evaluation process, preferably by an appropriate certifying body.
Pathology: The specialty of the practice of medicine dealing with the causes and nature of disease, contributing to diagnosis, prognosis, and treatment through knowledge gained by laboratory applications of the biologic chemical, or physical sciences to people, or through material obtained from people.
To protect its members, ACVP must follow suit.
Thus, this letter is an appeal to the membership of the ACVP and specifically to the professional standards committee to define who is a “physician pathologist” and what is “medical pathology.” The College of American Pathologists has set a prudent precedent. I believe we should follow their fine example by clearly defining and setting standards for who we are and what we practice.