STP Debate on the Desirability of an International Mechanism for Recognizing Qualified Toxicologic Pathologists

Abstract

The June 2009 Town Hall meeting of the Society of Toxicologic Pathology (STP) and a subsequent survey considered whether or not STP should endorse a published proposal (Toxicol Pathol 37: 553–561, 2009) by the International Federation of Societies of Toxicologic Pathologists (IFSTP) to provide global recognition by credential review for toxicologic pathologists engaged in regulatory-type, nonclinical toxicology studies. One-third (374 of 1082) of STP members answered the survey. The majority of respondents rejected the IFSTP proposal (55% against) but favored the concept of global recognition (57% for), if available to both anatomic pathologists and clinical pathologists (67% for). Members preferred recognition by credential review (49% for) or via an internationally authored “best practices” document detailing the ideal educational and work experiences required for entry-level proficiency in toxicologic pathology (43% for). Therefore, the STP Executive Committee does not endorse the current IFSTP proposal but will continue discussions on global recognition of qualified toxicologic pathologists with other societies of toxicologic pathology.

The Society of Toxicologic Pathology (STP) dedicated the Town Hall Session at its 2009 Annual Meeting to considering the topic “International Recognition of Qualified Toxicologic Pathologists.” The impetus for this discussion was the recent publication of a position paper proposing a global mechanism for recognition of qualified toxicologic pathologists (Ettlin et al. 2009). This paper, put forward by the International Federation of Societies of Toxicologic Pathologists (IFSTP), advocates credential review of an individual’s theoretical knowledge (education and accreditation) and practical skills (casework [e.g., formal residency] and on-the-job experience) to assess the likelihood that a toxicologic pathologist engaged in regulatory-type nonclinical toxicity studies is qualified, and will proficiently produce an acceptable product. The IFSTP recommended that this recognition be made available only to anatomic (“bench”) pathologists at first as this discipline represents by far the bulk of currently practicing toxicologic pathologists worldwide. However, the IFSTP was cognizant that the endorsement might need to be expanded in coming years to include other toxicologic pathology fields (e.g., clinical pathology, which currently is utilized in regulatory-type toxicologic pathology studies mainly in North America) once such disciplines develop a global toxicologic pathology presence.

This IFSTP proposal has been endorsed by the governing bodies of the IFSTP member societies representing Europe (ESTP) as well as the national societies of toxicologic pathology from France (SFPT), India (STP-I), Italy (SIPTS), Japan (JSTP), the Netherlands (NVT), South Korea (KSTP), and the United Kingdom (BSTP)—in short, all IFSTP member societies at the time the proposal was made except for the STP.1 Therefore, the STP Executive Committee chose this Town Hall topic to inform Society members of the potential advantages and disadvantages of such a recognition mechanism in advance of a Society-wide survey (conducted using online software [www.SurveyMonkey.com]) to define the members’ collective opinion regarding the concept and potential methods for implementing global recognition.

This commentary gives the major points made during the Town Hall discussion (collated from handwritten notes recorded during the Town Hall by one author [B.B.]) and also communicates the summary of the survey results.

Format of the STP Town Hall Meeting

The Town Hall session included an introduction to the role of the STP within the IFSTP, a tabular summary of the IFSTP credential review proposal (as set forth in Ettlin et al. 2009), and brief reviews of positions (1) supporting global recognition by credential review, (2) supporting global recognition only if accomplished by formal examination, and (3) against global recognition. This 20-minute overview was followed by 60 minutes of discussion. Approximately 250 STP members attended, as did a number of IFSTP officers and international guests from other societies of toxicologic pathology.

Construction of the Online Survey

Questions were drafted by the STP Executive Committee in advance of the Town Hall meeting and then revised after the meeting had been held. Three major areas requiring clarification were identified by the Executive Committee from members’ discussion points within the Town Hall meeting:

Does the STP membership favor the current IFSTP proposal for international recognition of qualified toxicologic pathologists (Question 1)?

Does the STP membership support any recognition mechanism at all for this purpose (Question 2)?

What disciplines within toxicologic pathology should be recognized in such a recognition system (Question 3)?

A fourth question was ultimately included to define what sort of recognition method might be acceptable to the membership, in the event that a mechanism was deemed to be desirable by respondents answering Question 2. Finally, a “Comments” box was incorporated to collect additional notes; these anonymous remarks can be accessed via the “Members Only” portion of the STP website (www.toxpath.org).

Two potential pitfalls were considered in defining the survey. The first, that STP members would be unaware of the issues behind the questionnaire, were addressed by substantial advance publicity. Information announcing the Town Hall meeting and the availability of the survey were delivered repeatedly to Society members in multiple venues (meeting program materials and intrasession announcements, e-mails, and the Scope newsletter). Basic concepts with respect to the general concept of international recognition for qualified toxicologic pathologists as well as the specific IFSTP recognition proposal were also presented in multiple fashions (introductory presentations and a handout at the Town Hall meeting, and the arguments within the IFSTP proposal itself [published in advance of the Town Hall meeting in Toxicologic Pathology, Ettlin et al. 2009). Finally, the cover letter for the survey included links to the entire IFSTP proposal (i.e., the Ettlin et al. 2009 paper) as well as the summary table within the paper describing the potential point system for evaluating applicants. The second possible pitfall, a low response rate among STP members, was not subject to direct manipulation except via the publicity campaign assembled to promote awareness of the issue. The data summarized below obviously provides no indication regarding the opinions of the “silent majority” of STP members who did not choose to participate in the survey. This absence represents a possible but unavoidable source of bias in the results.

Points Favoring the IFSTP Proposal for Global Recognition by Credential Review

The parallel pushes toward globalization and international harmonization of technical practices are major drivers in toxicologic pathology today. Regulatory agencies worldwide commonly receive product applications containing toxicologic pathology data that have been generated at institutions situated around the globe.

Several points were raised in favor of the IFSTP global recognition proposal. First, the existence of a global recognition mechanism would establish a common baseline definition for a qualified toxicologic pathologist, thereby permitting both employers and regulatory agencies to more easily judge whether or not a given individual will be capable of producing an adequate pathology report. Credential review offers the simplest conceptual means of implementing a global review system as the basic process can be readily adapted to fit an individual’s cultural background, while the use of multiple reviewers from within and outside a candidate’s geographic region will minimize potential bias in scoring a candidate’s educational and work experiences. Furthermore, credential review enjoys a successful history as a mechanism for recognizing qualified toxicologic pathologists, exemplified in the accreditations awarded in the Netherlands and Switzerland. Finally, the proposed IFSTP credential review mechanism for global recognition is intended to supplement rather than replace existing certification approaches. In this light, the IFSTP recognition would not be required for individuals who have been accredited by another rigorous means, such as the certifying examinations of the American College of Veterinary Pathologists (ACVP) or the College of American Pathologists (CAP) used widely in North America, but would provide a means by which toxicologic pathologists from countries that lack another well-defined certifying route might be able to exhibit their ability to perform proficiently.

Points Made Supporting Global Recognition Only If Undertaken by Examination

Neither credentials on paper nor length of work experience automatically equate to professional proficiency. Furthermore, creation of a common objective standard for reviewing credentials is unlikely given the marked diversity in educational and work experiences across training institutions, employers, cultures, and geographic regions.

Accordingly, several discussants delivered comments suggesting that any global recognition should be implemented using a universal examination format rather than by the proposed IFSTP credential review mechanism. A thorough examination would be an objective and legally defensible standard which would serve as the “gate” for ensuring that a pathologist does indeed possess a sufficient grasp of the knowledge and skills required for proficient practice (i.e., is “qualified). This point will be particularly telling in regions where historical and existing curricula and on-the-job experiences in toxicologic pathology have little rigor, although it also applies to those regions (including some in North America) in which neither educational institutions nor job-related apprenticeships are individually accredited for training in pathology, let alone toxicologic pathology. Furthermore, an examination is the only consistent means for evaluating the proficiency of the individuals who need recognition the most—persons without such accepted credentials as a formal postgraduate education and/or prior certification in pathology and who lack a strong background in toxicologic pathology. The complexity of designing and administering a fair global examination given the divergence in curricula, work experience, cultural mores (including language), and availability of testing resources (expert proctors and instrumentation) among nations were thought to be formidable but not insurmountable hurdles to launching an examination-based approach to global recognition. Many nations have spent considerable time, money, and energy to define their own standard definitions and requirements for assessing professional proficiency (e.g., U.S. National Commission for Certifying Agencies, http://www.noca.org). Negotiations to amend such national standards and/or efforts to apply such “local” standards to other regions that might already have their own established systems will be slow at best.

Points Raised Against Global Recognition

Many speakers voiced objections to the concept of global recognition in general, and the IFSTP credential review proposal in particular. A repeated observation was that the need for a global recognition mechanism was neither significant nor urgent given the absence of objective data showing that toxicologic pathology reports are often rejected because they had been prepared by a toxicologic pathologist who was considered to be “unqualified.” The long-standing practice of peer review was proclaimed as a well-recognized means among toxicologic pathologists, their employers, and regulatory agencies for assuring that toxicologic pathology reports are of acceptable quality; in fact, the rationale for peer review is that if the data and interpretation are approved by two or more experienced pathologists, then the report is acceptable, regardless of who finally signs it. Another argument was that a global recognition mechanism has no value for toxicologic pathologists who have one or more existing, well-established routes to gain accreditation as qualified pathologists (the typical case in North America), but instead will create a low bar by which individuals without access to rigorous training programs and/or reputable certifying mechanisms will yet be able to receive an “accreditation” in toxicologic pathology despite minimal education and the lack of appropriately supervised work experience. In this event, the potential flood of minimally proficient or incompetent pathologists who might attain recognition as “qualified” using a credential review approach was predicted to soon nullify the credibility of the IFSTP global recognition, and perhaps of existing certification mechanisms as well. Several speakers also anticipated substantial collateral damage to the standing of the toxicologic pathology profession as a whole due to the increase in pathology reports of questionable quality stemming from widespread outsourcing of toxicologic pathology work to inexperienced individuals in low-cost contract facilities (in any geographic location, but especially those springing up in developing nations). In summary, a global recognition mechanism was believed more likely to establish a meaningless qualification than to effectively propagate the suitable standards of quality for toxicologic pathology practice that have evolved over the last four decades in North America and other developed regions.

Discussants with this viewpoint did not consider a global examination to be a viable option for several reasons. First, the body of knowledge to be evaluated would be extensive, subject to regional biases, and not necessarily accessible across all venues, which could increase the time and expense required to gain an education of ample scope to pass a broad-based examination. Second, the cost and labor to create, implement, and defend a global examination was deemed prohibitive, even if the test was to be given in a single language using an Internet-based platform. Finally, other professions engaged in ensuring public safety do not administer global examinations, presumably for the same reasons, so the value added by a universal certifying examination would not be sufficient to warrant the effort. The consensus among the discussants was that the rigorous national and regional examinations of proficiency in general pathology (e.g., the ACVP or CAP tests in North America) or toxicologic pathology (e.g., the tests administered by the Japanese Society of Toxicologic Pathology or the Royal College of Pathology in the United Kingdom) already provide sufficient avenues for recognizing an individual’s qualifications and that adaptation of such existing “gold standard” tests should be encouraged in geographic regions that have yet to settle on a certifying mechanism.

General Comments on the Concept of Global Recognition

Several discussants delivered general comments regarding the nature of any global mechanism for recognizing qualified toxicologic pathologists. The first point was that recognition should be available to any scientist with a medical education (e.g., DVM, MD, or the equivalent) and/or doctoral-level graduate training (e.g., DSc, PhD, or the equivalent) in systems biology and comparative pathology, though the amount of relevant work experience should be higher for individuals without formal medical or veterinary training. A related opinion was that experienced PhD toxicologic pathologists (concentrated in Western Europe) might consider applying for global recognition on a credential review basis, but would be unlikely to attempt an examination this late in their careers; importantly, these veteran individuals were not felt to be at risk of either having reports rejected or losing their positions just because they had no formal accreditation in toxicologic pathology. An additional corollary was that young pathologists do not require global recognition by credential review because in the current global setting, they will likely have passed a more rigorous pathology certifying examination before they will have attained enough credentials to apply for IFSTP recognition. Finally, several speakers emphasized that a global recognition for toxicologic pathologists must encompass not only the anatomic pathology specialty but also the clinical pathology specialty.

The concept of global recognition was considered a real opportunity for the profession by some individuals. One reason is that a worldwide benchmark for quality could be used as an approach to disseminate the high standards of professional performance (in both technical and ethical aspects). An avenue suggested for achieving this goal was to develop a global “best practices” document defining the ideal educational and work experiences for ensuring that an entry-level toxicologic pathologist has the knowledge and skills to practice proficiently. Formulation of such a “best practices” standard was considered to be an essential first step toward undertaking a rational global recognition system, but would be a useful yardstick of an individual’s likely proficiency regardless of whether or not a global recognition mechanism based on the “best practice” standard was ever implemented. (This suggestion was adopted by the IFSTP Executive Committee at their June 2009 meeting; a single IFSTP “best practices” manuscript covering both anatomic pathology and clinical pathology will be prepared by an international committee and circulated to societies of toxicologic pathology worldwide for comment within the next few months.) A further advantage proposed for a global recognition mechanism was that the need to ensure quality performance among pathologists across diverse regions can be used to prepare basic and advanced continuing education courses that will help individuals in all regions to attain a greater degree of uniform professional training, as a means of engendering a more global assurance of professional competence.

Results of the STP Survey on the Desirability of Global Recognition

A 4-question, online survey to define the views of STP members on the concept of, and potential approaches to, global recognition of toxicologic pathologists engaged in regulatory-type nonclinical toxicology studies was released on June 24, two days after the 2009 STP Town Hall meeting. Just over a third (35% [374 of 1082]) of STP members who received the survey submitted responses to at least one question before the survey was closed (on July 15, 2009).

The data obtained from this survey clearly indicated that a majority (55%) of the respondents do not favor implementation of the current IFSTP proposal for global recognition using a credential review mechanism (Table 1, Question 1), though an equal number (57%) favored the concept of a global recognition method (Table 1, Question 2). In the event that a global mechanism for recognizing entry-level proficiency of toxicologic pathologists were launched, most respondents (69%) firmly advocate that both anatomic pathologists and clinical pathologists should be eligible (Table 1, Question 3). The most preferred formats for a global recognition system were to either implement a credential review process (49%) or to produce an international “best practices” document without any other recognition mechanism (43%), rather than to undertake global recognition via an examination (Table 1, Question 4).

STP Position on the IFSTP Proposal for Global Recognition by Credential Review

After considerable deliberation of points raised during the 2009 STP Town Hall meeting on “International Recognition of Qualified Toxicologic Pathologists” and review of the survey data regarding Society members’ opinions on the topic, the STP Executive Committee declines to endorse the current IFSTP proposal (Ettlin et al. 2009) to implement a global recognition mechanism based on credential review. This decision was made for two reasons. First, this choice reflects the majority view of those STP members who registered their opinion by voting in the recent survey regarding this question. Furthermore, the consensus of the STP Executive Committee is that, at least for the near term, development of a global “best practices” document defining the ideal educational and work experiences appropriate for recognition of qualified toxicologic pathologists will, if implemented consistently on a global basis and coupled with rigorous peer review, (1) ensure that the existing high standards for toxicologic pathology analysis and reporting will be adequately supported in all nations and (2) provide an effective impetus for propagating these standards into developing countries, and will best serve the present professional needs of the Society members who are their colleagues and constituents. However, the favorable opinion of the majority of STP survey respondents regarding the desirability of implementing some global recognition mechanism is considered by the STP Executive Committee as authorization to continue discussions on this issue with other societies of toxicologic pathology.