The Anatomic Pathology laboratory adjustments in the era of COVID-19 pandemic: The experience of a laboratory in a Portuguese central hospital.

The coronavirus disease 2019 (COVID-19) pandemic has dramatically changed the world over the past weeks, with already 8,25 million infections and 445,000 deaths worldwide, leading to an unprecedented international global effort to contain the virus and prevent its spread. The emergence of novel respiratory viruses such as the SARS-CoV-2 creates dramatic challenges to the healthcare services, including surgical pathology laboratories, despite their extensive daily experience in dealing with biological and chemical hazards. Here, we cover important aspects on the knowledge on COVID-19 gathered during the first six months of the pandemic and address relevant issues on human biological sample handling in the Anatomic Pathology laboratory in the context of COVID-19 global threat. In addition, we detail our strategy to minimize the risk of contamination upon exposure to the different biological products received in the laboratory, which can be of general interest to other laboratories worldwide. Our approach has enabled a safe work environment for laboratory staff, while ensuring the maintenance of high quality standards of the work performed. In times of uncertainty and given the lack of specific guidelines directed at Anatomic Pathology services to better deal with the global COVID-19 public-health emergency, it is essential to share with the community rigorous methodologies that will enable us to better cope with probable novel waves of COVID-19 infection and other viruses that will possibly arise in the near future.

Disinfection of corona virus in histopathology laboratories.

Severe acute respiratory syndrome (SARS CoV-2/COVID-19) is a highly contagious and deadly disease caused by a virus belonging to the coronaviridae family. Researchers working in histopathology laboratories, dealing with morbid samples, are particularly vulnerable to infection unless they have very strong immunity. Hence, a proper precautionary protocol is required for the safety of the laboratory staff. The current review highlights the biological and physical agents that can be used to inactivate the virus and disinfect the surrounding environment in the laboratory.

How Do We Make Clinical Molecular Testing for Cancer Standard of Care for Pathology Departments?

Understanding of the genetic basis and molecular pathogenesis of cancer has evolved substantially over the past century. The advent of high-throughput gene sequencing methods has unraveled hundreds of recurrent somatic genetic alterations in various malignancies, either causative or harboring major prognostic and/or predictive implications. Knowledge of these specific changes has dramatically altered diagnostic and therapeutic approaches to cancer, enabling personalized molecular therapies. This article shares approaches to adopting and fine-tuning the practice of molecular diagnostics as an essential component of diagnostic pathology in a tertiary care cancer hospital and proposes methods by which genetic testing in cancer can become standard of care in pathology departments across the nation.

Pathology-related cases in the Norwegian System of Patient Injury Compensation in the period 2010-2015. / Patologirelaterte saker i pasientskadeordningen i perioden 2010 ­ 15.

BACKGROUND: The Norwegian System of Patient Injury Compensation (NPE) processes compensation claims from patients who complain about malpractice in the health services. A wrong diagnosis in pathology may cause serious injury to the patient, but the incidence of compensation claims is unknown, because pathology is not specified as a separate category in NPE's statistics. Knowledge about errors is required to assess quality-enhancing measures. We have therefore searched through the NPE records to identify cases whose background stems from errors committed in pathology departments and laboratories. MATERIAL AND METHOD: We have searched through the NPE records for cases related to pathology for the years 2010 ­ 2015. RESULTS: During this period the NPE processed a total of 26 600 cases, of which 93 were related to pathology. The compensation claim was upheld in 66 cases, resulting in total compensation payments amounting to NOK 63 million. False-negative results in the form of undetected diagnoses were the most frequent grounds for compensation claims (63 cases), with an undetected malignant melanoma (n = 23) or atypia in cell samples from the cervix uteri (n = 16) as the major groups. Sixteen cases involved non-diagnostic issues such as mix-up of samples (n = 8), contamination of samples (n = 4) or delayed responses (n = 4). INTERPRETATION: The number of compensation claims caused by errors in pathology diagnostics is low in relative terms. The errors may, however, be of a serious nature, especially if malignant conditions are overlooked or samples mixed up.

Physician level reporting of surgical and pathology performance indicators: a regional study to assess feasibility and impact on quality.

BACKGROUND: There is increased awareness that, to minimize variation in clinician practice and improve quality, performance reporting should be implemented at the provider level. This optimizes physician engagement and creates a sense of professional responsibility for quality and performance measurement at the individual and organizational levels. METHODS: Individual provider level reporting was implemented within a provincial health region involving 56 clinicians (general surgeons, surgical oncologists, urologists and pathologists). The 2 surgical pathology indicators chosen were colorectal cancer (CRC) lymph node retrieval rate and pT2 prostate cancer margin positivity rate. Surgical resections for all prostate and colorectal cancer performed between Jan. 1, 2011, and Mar. 30, 2012, were included. We used a pre- and postsurvey design to obtain physician perceptions and focus groups with program leadership to determine organizational impact. RESULTS: Survey results showed that respondents felt the data provided in the reports were valid (67%), consistent with expectations (70%), maintained confidentiality (80%) and were not used in a punitive manner (77%). During the study period the pT2 prostate margin positivity rate decreased from 57.1% to 27.5%. For the CRC lymph node retrieval rate indicator, high baseline performance was maintained. CONCLUSION: We developed a robust process for providing physicians with confidential, individualized surgical and pathology quality indicator reports. Our results reinforce the importance of individual physician feedback as a strategy for improving and sustaining quality in surgical and diagnostic oncology.

[Alcohol-related mortality in the assessments of hospital unit physicians and pathologists: analysis of accounting medical documents].

AIM: To make a comparative analysis of the data available in the accounting medical documents drawn up at a multidisciplinary hospital on the level and structure of alcohol-related mortality (ARM) and to evaluate the efficiency of its accounting. MATERIALS AND METHODS: Accounting medical documents, such as 453 inpatient cards (Form 003/y), 453 postmortem protocols (cards) (Form 013/H-80), and 453 death certificates (Form 106/y-08), were chosen as the basis for the study. The data of the final clinical and postmortem diagnoses in the patients who had died at hospital and their primary cause of death were comparatively analyzed. RESULTS: According to Form 003/y, ARM was 5.5%; the detection rate of alcohol-related disease (ARD) was 11% (95% confidence interval (CI), 8.3 to 14.3%); according to Form 013/H-80, ARM was 7.1% (95% CI, 4.9 to 9.8%) and the detection rate of ARD was 12.6% (95% CI, 9.7 to 16%). The consistency of the diagnoses of ARD as a main cause of death, made by hospital unit physicians and pathologists, is estimated as the mean--the Cohen's kappa coefficient (kappa) is 0.570) (p < 0.001). CONCLUSION: The results of the investigation suggest that there are 3 types of ARM, which differ in its level and structure: ARM in the assessments of hospital unit physicians; that in the assessments of pathologists, and that according to the death certificates drawn up. The consistency index for the diagnosis of ARD as a main cause of death indicates that the hospital unit physicians only determine the etiology of alcohol-related cause of death, without identifying it specifically.

[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.

Role of duties related to COVID-19 suspected, probable and confirmed fatality cases / [Elhunytakkal kapcsolatos teendok COVID­19-gyanús, valószínusített és megerosített esetekben]

The outbreak caused by SARS-CoV-2 beta-coronavirus, first identified in Wuhan, China, was declared a pandemic by the World Health Organization on 11th March, 2020. In Hungary, the first confirmed COVID-19 case was reported on 4th March, 2020, and on 15th March, the first fatality related to the infection was announced. At the moment of the latter event, there was no central, standardized guideline, which could explain the necessary precautions, and provide an unequivocal description on how to handle the dead body. The procedure of transportation, storage, occurent autopsy or final disposition of the deceased raise a lot of questions, especially on how to carry out these tasks. Legislation related to infectious diseases and decedent management in general do not provide enough information on how to perform duties in a COVID-19 fatality case. The chief medical officer suspended the execution of autopsies, except in cases of unnatural death, since 19th March, however, the transportation and storage of fatalities can still be a problem. The Department of Pathology of the Healthcare Professional College of the Ministry of Human capacities published a procedure on recommended post-mortem duties on 21st March, but the suggested protocols only represent a narrow spectrum of international recommendations. Therefore supplementation may be necessary. Sadly, post-mortem protocols, in spite of their importance, are also underrepresented in the international literature. A further problem, wich makes adoptability difficult, is that available foreign guidelines and algorithms are optimized for different legislation, and organisations, resources not available in our country. In this article, besides providing a summary of literature, we would also like to make practical recommendations which may increase the safety of healthcare providers participating in the treatment or pathological duties with COVID-19 suspected, probable and confirmed cases. Orv Hetil. 2020; 161(17): 713­722.

WASP (Write a Scientific Paper): The role of the pathology department in clinical research.

The pathology laboratory is the hub of investigatory medical care, and constitutes an invaluable asset for clinical research. A number of disciplines fall under the cap of a pathology laboratory. Researchers may gain access to such services provided ethical and laboratory administrative permissions have been granted. While establishing the research budget it is essential to have a clear understanding of what goes on behind the path lab curtains as this may impinge on what can and cannot be done, financially and otherwise. Indeed, the process is far more complex than just handing a specimen and obtaining the respective result. Infrastructure, material and human resources need to be quantified and their respective costing identified. Liaison with the laboratory section personnel facilitates the smooth provision of service and research outcomes.

Digital workflow management for quality assessment in pathology.

Information systems (IS) are well established in the multitude of departments and practices of pathology. Apart from being a collection of doctor's reports, IS can be used to organize and evaluate workflow processes. We report on such a digital workflow management using IS at the Department of Pathology, University Hospital Magdeburg, Germany, and present an evaluation of workflow data collected over a whole year. This allows us to measure workflow processes and to distinguish the effects of alterations in the workflow for quality assessment. Moreover, digital workflow management provides the basis for the integration of diagnostic virtual microscopy.

[The significance of preventing pre-analytical errors in the pathology laboratory to obtain accurate pathological and cytological reports].

Pathological and cytological reports are unique, because the results are not numerical, and they may become the final diagnosis, having a direct bearing on further therapeutic decisions. Recently, the numbers of medical incidents/accidents, in which pathology technologists and/or pathologists have been involved, have been increasing. It is of concern that a lack of proper procedures in pathology practice may give rise to serious accidents affecting patients' lives. For accurate pathology diagnoses, highly skilled pathological technicians and well-knowledgeable pathologists are necessary but, in addition, precise quality assurance is essential. Efforts to prevent pre analytical errors are presented and discussed.

Biothreat agents and pathology laboratories.

Pathologists and laboratory staff are likely to be among the first health care workers to be aware that a potential bioterrorism attack has occurred. To prepare for such an event, it is necessary to be familiar with 1) the characteristics of bioterrorism attacks versus natural disease outbreaks, 2) which pathogens are potential bioterrorism agents; 3) the types of lesions that each causes; 4) the microbiological characteristics of each agent; 5) the Laboratory Response Network and reporting requirements, and 6) what resources are available.

Sustainable Development of Pathology in Sub-Saharan Africa: An Example From Ghana.

CONTEXT: - Pathology services are poorly developed in Sub-Saharan Africa. Komfo Anokye Teaching Hospital in Kumasi, Ghana, asked for help from the pathology department of the University Hospital of North Norway, Tromsø. OBJECTIVE: - To reestablish surgical pathology and cytology in an African pathology department in which these functions had ceased completely, and to develop the department into a self-supporting unit of good international standard and with the capacity to train new pathologists. DESIGN: - Medical technologists from Kumasi were trained in histotechnology in Norway, they were returned to Kumasi, and they produced histologic slides that were temporarily sent to Norway for diagnosis. Two Ghanaian doctors received pathology training for 4 years in Norway. Mutual visits by pathologists and technologists from the 2 hospitals were arranged for the introduction of immunohistochemistry and cytology. Pathologists from Norway visited Kumasi for 1 month each year during 2007-2010. Microscopes and immunohistochemistry equipment were provided from Norway. Other laboratory equipment and a new building were provided by the Ghanaian hospital. RESULTS: - The Ghanaian hospital had a surgical pathology service from the first project year. At 11 years after the start of the project, the services included autopsy, surgical pathology, cytopathology, frozen sections, and limited use of immunohistochemistry, and the department had 10 residents at different levels of training. CONCLUSIONS: - A Ghanaian pathology department that performed autopsies only was developed into a self-supported department with surgical pathology, cytology, immunohistochemistry, and frozen section service, with an active residency program and the capacity for further development that is independent from assistance abroad.

Recommendations for quality assurance and improvement in surgical and autopsy pathology.

Current regulations require that departments of pathology have a structured and active program of quality assurance (QA) and quality improvement (QI), with the goals of enhancing patient safety, minimizing error, ensuring timely delivery of reports, and monitoring physician competence. Types of potential error may evolve over time and, as regulations become progressively more stringent, QA/QI programs need to be constantly updated. The Association of Directors of Anatomic and Surgical Pathology herein provides guidelines for QA and QI in surgical and autopsy pathology.

The national head and neck histopathology external quality assurance scheme: evolution, design, and analysis of 11 circulations from 1999 to 2005.

The background and design of a specialised head and neck histopathology external quality assurance (assessment) scheme with optional oral and ENT arms is described. Participation (submission of response forms) exceeded 85% in eight of 11 slide circulations. In 60% of the 168 circulated cases, up to 33% (and in occasional cases, up to 56%) of respondents gave incomplete or wrong responses owing to a lack of awareness of specific diagnostic entities or to the misinterpretation of specific histological features. In all, there were 118 wrong responses, of which 58% could be considered "potentially serious". The scheme incorporates several design features which optimise the educational value. The stringent marking of cases, and the flagging of performances showing "a meaningful deviation in standard" based on the decision of peer members rather than a rigid numerical formula, encourages high standards.

Diagnostic 'errors' in anatomical pathology: relevance to Australian laboratories.

Failure to recognise that anatomical pathology diagnosis is a process of cognitive interpretation of the morphological features present in a small tissue sample has led to the public misperception that the process is infallible. The absence of a universally accepted definition of diagnostic error makes comparison of error rates impossible and one large study of laboratories in the United States shows a significant error rate of about 5%, most of which have no major impact on patient management. A recent review of the work of one pathologist in New South Wales confirms a lack of appreciation in medical administration that variable diagnostic thresholds result in an inherent fallibility of anatomical pathology diagnoses. The outcome of the review emphasises the need to educate both public and non-pathology colleagues of the nature of our work and brings into consideration the requirement to establish baseline error rates for Australian laboratories and the role of the Royal College of Pathologists of Australasia (RCPA) in developing fair and unbiased protocols for review of diagnostic errors. The responsibility of ensuring that diagnostic error rates are kept to the minimum is a shared one. Area health services must play their part by seeking to ensure that pathologists in any laboratory are not overworked and have adequate support and back-up from pathologists with expertise in specialised areas. It has been clearly enunciated by the Royal College of Pathologists in the United Kingdom that it is not safe for any histopathology service to be operated single-handedly by one histopathologist. Service managers and clinicians have to understand that country pathologists cannot provide the full range and depth of pathology expertise in the many clinical subspecialty areas that are often practised in non-metropolitan areas. Attending clinicians share the responsibility of accepting proffered pathology diagnoses only if it conforms to the clinical context. Pathology laboratories must continue to develop and maintain best-practice protocols and conduct periodic reviews of diagnosis, cytology-histology concordance, frozen section/permanent section correlations, conference reviews, intra and interdepartmental consultations, participate in external quality assurance programs and maintain ongoing education for all laboratory staff.

[The data-processing tool: an aid to implementation of quality assurance in a department of pathology. The example of Pap smears]. / Aide à la mise en place d'un système d'assurance qualité en anatomie et cytologie pathologiques: l'outil informatique. Application à la cytologie cervico-utérine.

Modern laboratory management software must be able to produce pathological reports for all specimens referred for diagnostic analysis, and must also be able to ensure improved quality for each step of the diagnostic process. Indices of diagnostic quality useful for staff members should be made available. The management software should enable user-friendly analysis and comparison in order to choose what kind of changes should to be applied for appropriate implementation of Quality Assurance procedures. This methodology is especially useful for Papsmears.