Disruptive Influences on Research in Academic Pathology Departments: Proposed Changes to the Common Rule Governing Informed Consent for Research Use of Biospecimens and to Rules Governing Return of Research Results.

Academic pathology departments will be dramatically affected by proposed United States federal government regulatory initiatives. Pathology research will be substantially altered if proposed changes to the Common Rule (Code of Federal Regulations: Protection of Human Subjects title 45 CFR 46) and regulations governing the return of individual research results are approved and finalized, even more so now that the Precision Medicine initiative has been launched. Together, these changes are disruptive influences on academic pathology research as we know it, straining limited resources and compromising advances in diagnostic and academic pathology. Academic research pathologists will be challenged over the coming years and must demonstrate leadership to ensure the continued availability of and the ethical use of research pathology specimens.

[Autopsies at the boundary between pathology and forensic medicine : Suggestions for interdisciplinary cooperation]. / Obduktionen im Grenzbereich zwischen Pathologie und Rechtsmedizin : Vorschläge zur interdisziplinären Kooperation.

There are many differences between forensic medicine and pathology but also many similarities, as they share a common basis. In this article the characteristics of the forensic autopsy and it's legal foundations are presented. Furthermore, possibilities are discussed for a cooperation between forensic medicine and pathology to increase the rate of autopsies. This could contribute to the legal certainty, to the quality assurance and to the training of physicians.

How concerns and experiences with medical malpractice affect dermatopathologists' perceptions of their diagnostic practices when interpreting cutaneous melanocytic lesions.

OBJECTIVE: We sought to identify characteristics associated with past malpractice lawsuits and how malpractice concerns may affect interpretive practices. METHODS: We surveyed 207 of 301 (68.8%) eligible dermatopathologists who interpret melanocytic skin lesions in 10 states. The survey assessed dermatopathologists' demographic and clinical practice characteristics, perceptions of how medical malpractice concerns could influence their interpretive practices, and past malpractice lawsuits. RESULTS: Of dermatopathologists, 33% reported past malpractice experiences. Factors associated with being sued included older age (57 vs 48 years, P < .001), lack of board certification or fellowship training in dermatopathology (76.5% vs 53.2%, P = .001), and greater number of years interpreting melanocytic lesions (>20 years: 52.9% vs 20.1%, P < .001). Of participants, 64% reported being moderately or extremely confident in their melanocytic interpretations. Although most dermatopathologists believed that malpractice concerns increased their likelihood of ordering specialized pathology tests, obtaining recuts, and seeking a second opinion, none of these practices were associated with past malpractice. Most dermatopathologists reported concerns about potential harms to patients that may result from their assessments of melanocytic lesions. LIMITATIONS: Limitations of this study include lack of validation of and details about the malpractice suits experienced by participating dermatopathologists. In addition, the study assessed perceptions of practice rather than actual practices that might be associated with malpractice incidents. CONCLUSIONS: Most dermatopathologists reported apprehension about how malpractice affects their clinical practice and are concerned about patient safety irrespective of whether they had actually experienced a medical malpractice suit.

State restrictions on the interstate practice of dermatopathology are unconstitutional: the tissue is the issue.

The regulation of the interstate practice of dermatopathology, teledermatopathology and teledermatology is the subject of discussion in many recent articles. Laws and regulations in many states complicate such interstate practice, requiring the dermatopathologist to be licensed in the state where the biopsy is taken if the dermatopathologist practices in and is licensed in a different state. To date, this discussion has been from the viewpoint of the dermatopathologist or dermatologist. But, when seen from the patient's viewpoint, its apparent that most such state regulation may be void as an unconstitutional infringement of a patient's fundamental right of unrestricted interstate travel under the Constitution of the United States of America.

[The role and place of pathology services in ensuring and improving the quality of medical care: Organizational and legal aspects].

The paper considers the legal and organizational issues of the activity of pathology services in improving medical care. It shows the main (diagnostic and medico-organizational) areas of pathology work to improve the quality of medical care.

Dermatology and pathology arrangements: navigating the compliance risks.

Purchased service arrangements, establishing in-house professional pathology services, conducting technical component histology within a dermatology practice, and electronic medical records technology donations are ways that dermatology practices are responding to the current health care delivery and payment changes. This article will provide a general framework for navigating the compliance risks and structure considerations associated with these relationships between dermatologists and pathologists.

[Current medicolegal and ethical issues in pathology]. / Aktuelle medizinrechtliche und -ethische Herausforderungen der Pathologie.

The increase in density of information available in relation to patients and research participants, in particular in the context of genetic diagnostics and analysis, results in an increased potential for uncovering details which were unexpected but are of particular significance for the patient. Deciding how this information is dealt with and who is entitled to receive this information, is a medicolegal and ethical balancing act. Incidental findings and the challenges posed by the advent of personalised medicine are but two areas which increasingly impact medical disciplines that do not conventionally work directly with patients. Both areas raise questions of what is legally required and morally necessary. The authors briefly sketch these two areas and the medicolegal and ethical implications for diagnostics and research in pathology.

[Post mortem dissections -the legal status in Israel].

Forensic medicine is the application of science to the medical disciplines to answer questions related to criminal law. Most forensic practitioners are physicians with expertise in pathology. In the field of post mortem surgeries, the extensive area of the encounter between the law and medicine is compLicated. The doctor who is responsible for the procedure needs to take decisions on the cause of death, as well as considerations of Legal and religious issues. Furthermore, the doctor needs to take into consideration the requests of the family of the deceased. This article aims to reveal the legal, medical and moral complexity of post mortem surgeries, especially in the last few years during which new imaging techniques developed may pose as reasonable alternatives for such surgeries.

The UEMS section/board of pathology, chapter 6: requirement for recognition of postgraduate training in pathology: a presentation of the paris document.

After more than five years discussion the UEMS Section/Board of Pathology agreed a specification of requirements for recognition of post-graduate training in pathology, which is the key to the future of our discipline. The document published here, subject to ratification by UEMS Council, was voted on and accepted by the Pathology Board at the UEMS Paris meeting of 9 June 2012. Cytopathology is regarded as integral part of pathology: in general, training in pathology takes five years and maintains a common trunk of four (minimum three) years where surgical pathology, autopsy pathology and basic knowledge of neuropathology, dermatopathology and cytopathology are adequately trained and assessed. Training in so-called 'areas of interests' covers the remaining 12-24 months. Certificates of 'advanced level of competence' remain within the authority of national boards. As senior members of its Executive Board, we believe that the European Federation of Cytology Societies (EFCS) should take responsibility for establishing 1) standards in the quality of cytopathology training, 2) training guidelines and qualification for advanced levels of competence in cytopathology, 3) manpower planning, 4) tutorials for pathologists and cytotechnologists and 4) standards of cytotechnologist training.

The Pathology Laboratory Act 2007 explained.

The past century has seen tremendous changes in the scope and practice of pathology laboratories in tandem with the development of the medical services in Malaysia. Major progress was made in the areas of training and specialization of pathologists and laboratory technical staff. Today the pathology laboratory services have entered the International arena, and are propelled along the wave of globalization. Many new challenges have emerged as have new players in the field. Landmark developments over the past decade include the establishment of national quality assurance programmes, the mushrooming of private pathology laboratories, the establishment of a National Accreditation Standard for medical testing laboratories based on ISO 15189, and the passing of the Pathology Laboratory Act in Parliament in mid-2007. The Pathology Laboratory Act 2007 seeks to ensure that the pathology laboratory is accountable to the public, meets required standards of practice, participates in Quality Assurance programmes, is run by qualified staff, complies with safety requirements and is subject to continuous audit. The Act is applicable to all private laboratories (stand alone or hospital) and laboratories in statutory bodies (Universities, foundations). It is not applicable to public laboratories (established and operated by the government) and side-room laboratories established in clinics of registered medical or dental practitioners for their own patients (tests as in the First and Second Schedules respectively). Tests of the Third Schedule (home test blood glucose, urine glucose, urine pregnancy test) are also exempted. The Act has 13 Parts and provides for control of the pathology laboratory through approval (to establish and maintain) and licensing (to operate or provide). The approval or license may only be issued to a sole proprietor, partnership or body corporate, and then only if the entity includes a registered medical practitioner. Details of personnel qualifications and laboratory practices are left to be specified by the Director-General of Health, providing for a formal recognition process and room for revision as pathology practices evolve. Encompassed in the responsibilities of the licensee is the requirement that samples are received and results issued through, and management vested in, a registered medical or dental practitioner. This effectively prohibits "walk-ins" to the laboratory and indiscriminate public screening. The requirement for a person-in-charge in accordance with class and speciality of laboratory ensures that the laboratory is under the charge of the pathology profession. Examined carefully, the requirements of the Act are similar to laboratory accreditation, but are backed by legislation. Many of these details will be spelt out in the Regulations, and these in turn are likely to fall back on National professional guidelines, as accreditation does. Although not at first obvious, enforcement of the Act is based on self-regulation by pathology laboratory professionals. Sincere professional input is thus required to embrace its philosophy, ensure rational and transparent enforcement of legislation, and develop National guidelines for good pathology practices upon which enforcement may be based.

Melanocytic nevi simulant of melanoma with medicolegal relevance.

A group of melanocytic benign nevi are prone to be misdiagnosed as nodular or superficial spreading melanoma. This review illustrates the most frequent forms of these nevi in direct comparison with their malignant morphologic counterparts. The nevi are: hyper-cellular form of common nevus to be distinguished from nevoid melanoma, Spitz nevus (vs spitzoid melanoma), Reed nevus (vs melanoma with features of Reed nevus), cellular atypical blue nevus (vs melanoma on blue nevus), acral nevus (vs acral melanoma), Clark dysplastic nevus (vs superficial spreading melanoma), desmoplastic nevi (vs desmoplastic melanoma), benign proliferative nodules in congenital nevi (vs melanoma on congenital nevi), epithelioid blue nevus (vs animal type melanoma) and regressed nevus (vs regressed melanoma). For each single 'pair' of morphological look-alikes, a specific set of morphological, immunohistochemical and genetic criteria is provided.

Medicolegal liability in pathology: an international perspective.

An inevitable outcome of modern Medicine in any country is that some patients will experience adverse events, some of which would have been preventable. Different nations have developed various approaches to such cases; their legal efficacies are probably dissimilar and dependent on a number of disparate variables. An international "snapshot" of the results of the interacting forces can be obtained by asking physicians in several countries how they view selected subjective facets of their tort systems. In the U.S., many physicians view the structure of malpractice torts as unfair, and that belief is shared by at least some pathologists. The American Medical Association has declared that a multiregional malpractice "crisis" exists which raises medical costs and threatens access to care. Furthermore, malpractice tort decisions are often flawed scientifically because lay jurors and judges cannot properly evaluate the quality of "expert" testimony given by adversarial witnesses. Despite these factors, there has been little effort to investigate the views of pathologists on malpractice actions outside the U.S. In this paper, the authors have collected the responses of an international group of pathologists to a questionnaire on that topic. The respondents practice in academic centers in 15 countries outside the U.S. As expected, a range of views was represented, with some pathologists reporting that malpractice litigation was uncommon and others noting a worrisome trend toward its growth. Interestingly, so-called "defensive medicine" was found to be relatively common in pathology in many countries.

Providing medicolegal testimony.

One of the major goals of residency training is to prepare pathologists to communicate effectively in a variety of clinical settings. Well-educated pathologists are able to explain medical facts and offer cogent opinions to audiences that vary from other physicians to laypersons. As would be expected, there is an overlap between the skill-set required for medical communication and the skill-set necessary to participate effectively in malpractice litigation. However, residency curricula do not specifically prepare pathologists for the unique challenges posed by legal proceedings. The resulting lack of preparation may leave pathologists poorly prepared to be confronted by the "black-and-white" world in which attorneys try to live and work, but avoidance of that world is not always possible. Lawsuits against physicians are common, and even if the unpleasant experience of being sued is avoided, there is a high probability that one will, at least, be required to serve as a "fact witness" to provide sworn testimony if a suit has been filed against a physician colleague. In addition, some pathologists voluntarily provide the professional testimony required by the tort system, when it attempts to integrate science and Law. This paper is directed at pathologists who have had little or no prior experience with the legal system. The authors hope that the information provided therein will lessen physician vulnerability in and out of the courtroom, vis-à-vis malpractice litigation.

Tort reform: the pathologists' perspective.

Physicians who become ensnarled in malpractice litigation often feel that the tort system has treated them unfairly. This negative perception has fueled physician efforts to enact "reforms" intended to mitigate the damage that allegations of medical negligence currently have on both individual physicians and on the practice of medicine itself. Although physicians are generally enthusiastic about "reform," there is currently no definition that allows tort "reform" to be separated from related initiatives. Some physicians largely restrict the term to defendant-friendly changes in the rules and procedures governing the workings of the tort system, whereas others take a somewhat broader view. In the present paper, we have favored the broader approach to the topic, leading to a discussion of 30 measures that have been presented in the context of tort "reform." Although most of these measures involve changes in the complex rules governing the malpractice tort system itself (eg, capping jury awarded damages), our broader view of "reform" also includes attempts to exert influence on the tort system from the outside (eg, peer review of expert testimony) and measures designed to keep patient dissatisfaction out of the tort system (eg, apology for error). Some would argue for an even broader view of tort "reform" that would including measures for reducing the pool of dissatisfied patients. For example, trial lawyers have claimed that physicians have put far too much effort into "reforms" that reduce the legal consequences of committing medical errors, and not enough effort into "reforms" that would reduce the errors themselves. The latter point may or may not have some validity, but there is a natural demarcation between measures designed to align medical outcomes with patient expectations (eg, error reduction, better diagnostic technology) and others designed to improve the processes that resolve patient dissatisfaction. Only the latter meet our definition of tort "reform."

Medical devices; hematology and pathology devices; classification of cord blood processing system and storage container. Final rule.

The Food and Drug Administration (FDA) is classifying a cord blood processing system and storage container into class II (special controls). The special control that will apply to this device is the guidance document entitled "Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container." FDA is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of this device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device.

[Pathologists' assistant system in Japan].

A pathologists' assistant (PA) is recognized as a well-trained clinical technologist in pathologic examinations. Some nations including the United States and United Kingdom have developed such roles with good results. In Japan, there are some serious problems with the PA system. The most important problem is the limitation of activity, such as cutting specimens and screening biopsy samples. The latter probably conflicts with Japanese medical law. Although a PA system would relieve the burden on pathologists it should be careful to introduce of a PA system in Japan.

Evidence-based medicine and tort law.

Recent statutes and legal decisions have been aimed at bettering the quality of tort-law decisions by substantively improving "expert" testimony. However, in analogy to the experience of physicians attempting to upgrade medical practice using the principles of evidence-based medicine, lawyers and the courts have found it much easier to describe ideal science than to actualize it. This is particularly so in a system (the Law) that has traditionally not been very discerning about scientific rigor, and which has established procedural priorities that are often incompatible with strict scientific standards. This overview will examine the American tort system from an evidence-based perspective. We include a discussion of standards that could be used for "outcomes analysis" in the Law; recognition and classification of errors made by the courts themselves; the relationship between medical errors, "negligence," and standard of care; and the problem of reconciling the rights of plaintiffs with medical-scientific facts. We also consider selected impediments to developing a legal system that is capable of consistently reaching evidence-based decisions concerning complex scientific information, including pathologic interpretation of tissue specimens.

Pathologists and the judicial process: how to avoid it.

This review article covers the full range of issues concerning malpractice as it relates to pathologists. Following a brief summary as to the incidence and general statistics on the outcome of lawsuits as well as common pathology misdiagnoses resulting in lawsuits, the definition of malpractice is discussed. These include duty, breech of standard of care, proximal cause, and damage. Details are provided as to what a pathologist should do from the initial threat of a lawsuit, to the initial lawsuit, and through the initial physician/lawyer meeting. An in-depth analysis as to how pathologists should handle themselves through the discovery process and, in particular, deposition is provided. Plaintiff attorneys' goals at deposition are covered in depth. These goals include: 1) education about the pathologist's case and strategies; 2) impeachment of the pathologist's credibility; and 3) judgment as to how effective a witness the pathologist will be at trial. Various types of plaintiff's attorney at deposition are summarized. Also discussed is the post-deposition meeting with the legal representative, whether to settle, and specific issues relating to trial. Finally, general tips on how to avoid a lawsuit in pathology are reviewed.

Medicolegal issues. An anatomic pathologist's perspective.

In the practice of anatomic pathology, the standard of care must be met in all instances if the possibility of an adverse legal action is to be avoided. Whether one practices surgical, cyto-, or necropsy pathology, one is at risk. Constant vigilance, following appropriate guidelines, and well-designed quality assurance programs are all important in reducing the possibility of litigation. During intraoperative consultations direct communication with the surgeon is often essential. If an adequate legal defense is to be had, documentation of the precautions taken in an individual case is necessary. Outside consultants should be chosen carefully based on their expertise in the area of concern, and preferably only one consultation should be requested on a particular case. House staff in training should be given graduated responsibility, but their work, in general, should be supervised by an attending pathologist who has hospital privileges. In giving testimony as a defendant, one should never admit a departure or deviation from the standard of care. As an expert witness, it is important that one's testimony be objective and impartial. One should not attempt to answer questions outside one's area of expertise.