US Food and Drug Administration Approval of Whole Slide Imaging for Primary Diagnosis: A Key Milestone Is Reached and New Questions Are Raised.

April 12, 2017 marked a significant day in the evolution of digital pathology in the United States, when the US Food and Drug Administration announced its approval of the Philips IntelliSite Pathology Solution for primary diagnosis in surgical pathology. Although this event is expected to facilitate more widespread adoption of whole slide imaging for clinical applications in the United States, it also raises a number of questions as to the means by which pathologists might choose to incorporate this technology into their clinical practice. This article from the College of American Pathologists Digital Pathology Committee reviews frequently asked questions on this topic and provides answers based on currently available information.

Pathological findings in explanted vaginal mesh.

In light of the legal issues and the shortage of data on histopathological findings, we summarized our experience on how explanted vaginal mesh specimens were managed in a surgical pathology practice during the last 5 years. Clinical history and pathology reports were collected from 155 women undergoing transvaginal tape excision. The degree of chronic inflammation, fibrosis, foreign-body giant cell reactions, the number of capillary vessels and nerve fibers, and the presence or absence of adipose tissue were recorded. Among the 155 patients, 65 (41.9%) were active medicolegal cases, with a significant increase in recent years. The main medical indications for mesh excision were pelvic pain, mesh erosion, voiding dysfunction, genital organ prolapse, and vaginal bleeding. In most cases, mild to moderate chronic inflammation with a mild degree of foreign-body giant cell reaction and minimal to mild fibrosis were found in explanted mesh specimens. The specimens were well vascularized without any evidence of nerve abnormality. Patient age correlated negatively with vaginal pain (P = .007) but positively with erosion (P = .005). In addition, the presence of adipose tissue within the explanted mesh correlated significantly with pelvic pain (P = .016). Overall, there was good tissue integration in all specimens. Considering the significant increase in the number of lawsuits in recent years, we recommend that all explanted vaginal mesh specimens be examined microscopically as well as grossly. A list of microscopic findings, including the presence or absence of adipose tissue, is suggested.

Stuck between a scalpel and a rock, or molecular pathology and legal-ethical issues in use of tissues for clinical care and research: what must a pathologist know?

Personalized medicine and health care reform offer the opportunity for pathologists to have a more central and visible role in patient care. Pathologists face new and more complicated requests for clinical and research testing on tissue specimens, including testing for somatic and inherited mutations. Pathologists must comprehend the applications and requirements for molecular testing and their legal and ethical responsibilities in handling tissue requests for clinical and research purposes to best serve the needs of patients and clinicians and to comply with federal and state laws. This article reviews these rapidly evolving and complex areas.

Pathology consultation on reporting of critical values.

Among the most important functions of a pathology or laboratory medicine service is the clear, accurate, and rapid communication of critical test results (critical values) to patient care providers. Pathologists and laboratory professionals are often confronted with many obstacles in the reporting of such critical values, including establishing clinically relevant criteria for critical values, resolving difficulties in locating an ordering provider when a critical value is obtained, and ensuring that the provider understands the severity and implications of a critical result when he or she has questions. This article presents a hypothetical (yet fairly common) clinical case scenario regarding critical values and then provides an up-to-date discussion and review of the literature on the reporting of critical results.

When is the practice of pathology malpractice?

Because of its complex nature, surgical pathology diagnosis has an appreciable degree of fallibility and is increasingly subject to legal scrutiny. In litigation, the first practical step is to explain why and how this adversity could happen, and the second is the question of apportionment of responsibility and its legal consequences. As pathologists, we have to provide a methodology of investigation allowing a clear distinction between reasonable and unacceptable pathology practice without the twist of hindsight. For that we need to examine the different steps from test ordering to the final report. The most critical aspect of the enquiry is the act of diagnosis itself. What can reasonably be expected and what precautions have normally to be taken? Experts are often requested to re-examine the slides. For that we need a well-devised protocol enabling blinded review. Tort law has two important interconnected goals: compensation for damages and prevention of the same slip ever being made again. We can only properly learn from our mistakes if we carry out an unbiased investigation. Poor normative judgement of diagnostic failures will backfire on the profession.

[Accreditation in pathology. Systematic presentation and documentation of activities in pathology]. / Akkreditierung in der Pathologie. Systematische Darstellung und Dokumentation der Tätigkeiten in der Pathologie.

In the last ten years, almost 60 departments of surgical pathology were accredited in Germany according to DIN EN ISO/IEC 17020. Accreditation in pathology was accompanied by the adoption of a highly dynamic process, which requires staff to be more aware of quality and to introduce a quality-oriented system. The accreditation body in turn needed to consider all the duties, responsibilities and processes in surgical pathology and was supported in this regard by the Sector Committee of Pathology and Neuropathology of the DGA German Association for Accreditation. In this review we illustrate the various problems associated with accreditation in surgical pathology by answering eight questions that have arisen over many years of activity. These include the registration and appropriate presentation of the scope of accreditation, the terminology, as well as the extent and depth of documentation. A department of pathology applying for accreditation is required to document the entire step-wise process leading to a surgical pathological diagnosis.

Significant and unexpected, and critical diagnoses in surgical pathology: a College of American Pathologists' survey of 1130 laboratories.

CONTEXT: The Joint Commission and the College of American Pathologists have emphasized improved communication as a strategy to improve patient safety and reduce errors. OBJECTIVE: To determine current policies and practices concerning critical and/or significant and unexpected results in anatomic pathology. DESIGN: A survey was distributed with the 2007 D mailing of the Performance Improvement Program slides. The survey included questions that determined laboratory size, practice setting, and anatomic pathology critical and/or significant and unexpected result policies and practices. RESULTS: Surveys from 1130 laboratories were received. A total of 75% had a written policy regarding anatomic pathology critical and/or significant and unexpected results; 25% did not. A total of 30% of laboratories with written policies stated that their policies included guidelines but did not include specific examples. A total of 33% listed 5 or fewer specific examples, 18% listed more than 5 examples, and 19% stated that they had a specifically defined list of significant and unexpected and/or critical diagnoses. The conditions that were listed included malignancies (48% of all laboratories), findings not expected by the clinical history (45%), life-threatening infections (45%), no chorionic villi in products of conception (37%), inflammatory or immunologic processes (19%), and organ rejection (14%). Laboratories with a higher median number of accessioned surgical and cytology cases and independent laboratories tended to have policies with more than 5 specific examples or precise lists of must-call diagnoses (P < .001). CONCLUSIONS: This survey illustrates current anatomic pathology policies and practices with respect to critical and significant and unexpected results.

Medicolegal aspects of telepathology.

A pathologist may practice telepathology in another room from the original slide using the hospital intranet, he/she may practice it if a CD-ROM is reviewed with a "virtual histologic image" or digital slide. As pathology becomes increasingly subspecialized, and pathologists are progressively more engaged in practices situations where they may not be in a centralized laboratory location, use of telepathology technology may be increasingly common. We touch on select medicolegal and reimbursement issues in the practice of telepathology. Primary and secondary legal sources are reviewed, as well as primary medical references. Telepathology is an evolving area of telemedicine. Guidelines for primary opinion telepathology should be driven from best practices in conventional laboratory procedures and can enhance the practice of pathology. However, it should be undertaken with the understanding that the legal and regulatory environment involving such practices is evolving as well.

The legal system and the surgical pathologist: through the eyes of the defendant.

An overview of the legal process is presented, on the basis of the experience gained from being a defendant. Some issues other than pure diagnostic errors that may result in litigation are highlighted. False medical testimony and procedures in place for sanctioning such testimony are discussed.

Medicolegal liability in surgical pathology: a consideration of underlying causes and selected pertinent concepts.

Malpractice actions against surgical pathologists are still relatively uncommon, but they have increased in frequency over time and are associated with sizable indemnity figures. This discussion categorizes areas of liability in surgical pathology into three groups: those that represent health system flaws (problems with specimen identification, or transportation, or both; lack of clinical information or erroneous information; sampling effects and defects; and poorly reproducible or poorly defined diagnostic or prognostic criteria), others that exist at the interface between the system and individuals (allowing clinicians to bypass pathologic review of referred specimens; acceding to clinical demands for inadvisable procedures; and working in a disruptive environment), and truly individual errors by pathologists (lapses in reasoning; deficiencies concerning continuity in the laboratory; invalid assumptions regarding recipients of surgical pathology reports; over-reliance on the results of "special" tests; and problems with peer consultation). Finally, two important topic areas are discussed that commonly enter into lawsuits filed against surgical pathologists; namely, "delay in diagnosis" of malignant neoplasms and "failure to provide adequate prognostic information." Based on a review of the pertinent literature, we conclude that the clinical courses of most common malignancies are not affected in a significant manner by delays in diagnosis. Moreover, the practice of using "personalized external validity" for supposedly prognostic tests is examined, with the resulting opinion that prognostication of tumor behavior in individual patients is not reliable using anything but anatomic staging systems.

'Bones of contention': a donor register for temporal bone donation?

INTRODUCTION: Temporal bone dissection is essential training for otological surgery. Organ retention scandals have made it difficult to obtain consent for cadaveric temporal bone removal. The current literature does not address the means of acquiring a steady supply of cadaveric temporal bones for medical education and training. The US national temporal bone registry has established a temporal bone donor bank for medical education and research. Could a similar programme in the UK be an answer to the paucity of temporal bones? OBJECTIVES: (1) To ascertain the degree of interest amongst our regional patient population in a 'living will' pledge for temporal bone donation for medical education and research. (2) To delineate a demographic profile of potential temporal bone donors. DESIGN, SETTING AND PARTICIPANTS: One thousand questionnaires were distributed to patients and relatives attending out-patient clinics; 920 people responded. RESULTS: Seventy per cent of respondents supported temporal bone donation for medical education and research. Potential temporal bone donors tended to be ENT clinic attenders, to suffer from hearing difficulties or to have had previous ear surgery (p<0.001). Strong support also came from non-ENT clinic attenders. CONCLUSIONS: There was strong support amongst our regional patient population for a 'living will' pledge for temporal bone donation for medical education and research. Based on our donor profile, we propose a temporal bone donor programme, starting on a regional basis with possible expansion nationwide. This programme would recruit donors from amongst patients attending ENT out-patient clinics, as a long term solution to improve the supply of temporal bones.

Medicolegal aspects of error in pathology.

OBJECTIVE: To discuss the various ways error is defined in surgical pathology. To identify errors in pathology practice identified by an analysis of pathology malpractice claims. DESIGN: Three hundred seventy-eight pathology malpractice claims were reviewed. Nuisance claims and autopsy claims were excluded; 335 pathology claims remained and were analyzed to identify repetitive patterns of specimen type and diagnostic category. SETTING: All pathology malpractice claims reported to The Doctors Company of Napa, Calif, between 1998 and 2003. RESULTS: Fifty-seven percent of malpractice claims involved just 5 categories of specimen type and/or diagnostic error, namely, breast specimens, melanoma, cervical Papanicolaou tests, gynecologic specimens, and system (operational) errors. Sixty-three percent of claims involved failure to diagnose cancer, resulting in delay in diagnosis or inappropriate treatment. CONCLUSION: A false-negative diagnosis of melanoma was the single most common reason for filing a malpractice claim against a pathologist. Nearly one third involved melanoma misdiagnosed as Spitz nevus, "dysplastic" nevus, spindle cell squamous carcinoma, atypical fibroxanthoma, and dermatofibroma. While breast biopsy claims were a close second to melanoma, when combined with breast fine-needle aspiration and breast frozen section claims, breast specimens were the most common cause of pathology malpractice claims. Cervical Papanicolaou test claims were third in frequency behind melanoma and breast; 98% involved false-negative Papanicolaou tests. Forty-two percent of gynecologic surgical pathology claims involved misdiagnosed ovarian tumors, and 85% of these were false-negative diagnoses of malignancy. The most common cause of system errors was specimen "mix-ups" involving breast or prostate needle biopsies.

An insurer's perspective on error and loss in pathology.

OBJECTIVES: To identify errors in surgical pathology practice that lead to malpractice claims, and to define the frequency and severity of pathology malpractice claims and discuss the implications. DESIGN: Three hundred seventy-eight pathology malpractice claims reported to The Doctors Company of Napa, Calif, between 1998 and 2003, were reviewed. Nuisance claims and autopsy claims were excluded; the 335 remaining claims were analyzed. RESULTS: Pathology claim frequency is low. Pathology claim severity is high, especially for claims involving a misdiagnosis of melanoma or a false-negative Papanicolaou test. Fifty-seven percent of claims involved the following 5 categories: breast specimens, melanoma, Papanicolaou smears, gynecologic specimens, and operational error. Sixty-three percent of claims involved failure to diagnose cancer, resulting in delay in diagnosis or inappropriate treatment. CONCLUSION: A false-negative diagnosis of melanoma is the single most common reason for filing a malpractice claim against a pathologist. Nearly one third of misdiagnoses involve melanoma misdiagnosed as Spitz nevus, "dysplastic" nevus, spindle cell squamous carcinoma, atypical fibroxanthoma, and dermatofibroma.

[Changes in tissue viability of digestive organs in current surgical pathology]. / Zminy zhyttiezdatnosti tkanyn orhaniv travlennia pry aktual'nii khirurhichnii pataohiï.

Modern surgical treatment of people according with legislation and health care law has to consider defining of tissue viability. The paper deals with the technique directed to evaluate specific tissue viability by structure functional alterations indices of mitochondrion crista. The technique can be introduced into clinic practice for above mentioned purposes.

Medicolegal issues and fine needle aspiration of the breast. What you can do to decrease your risk of being sued.

Carcinoma of the breast is the most litigated cancer in women. This article discusses steps that can be taken to reduce the risk of being sued. Topics covered include laboratory practices, patient contact, informed consent, documentation, record keeping, interpretive problems, triple test, diligence, and reporting results as well as what to do if sued.