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Introduction The number of impalpable breast lesions requiring pre-operative lesion localization (PLL) continues to increase. The use of Radio-guided Occult Lesion Localization with Iodine 125 Seeds (ROLLIS) offers multiple benefits for the multidisciplinary team (MDT), but is not without challenges. Aims The aims of this audit were to review our multidisciplinary team's experience following introduction of ROLLIS as standard of care for PLL, identify challenges and evaluate seed placement accuracy (SPA). Results/outcomes Over a nineteen month period, 327 seeds were inserted: 96% of single seed localizations were within 10 mm, 91% within 5 mm and 42% within or in contact with the lesion (or marker clip surrogate) on post-insertion two view mammography. Each component of the MDT reported on benefits of the ROLLIS program and challenges faced. Examples included: an undetectable seed in the operating room, a seed damaged in pathology during specimen processing, suboptimal seed position requiring hook-wire localization (HWL) and delayed seed removal in a patient who initially refused to return for surgery. Conclusion ROLLIS results in high seed placement accuracy. Despite clear advantages, use of ROLLIS presents some multidisciplinary challenges. Robust patient information, training of new staff and adherence to strict policies and protocols are required to ensure safe delivery of a ROLLIS program.

The International Society of Gynecological Pathologists (ISGyP) Endocervical Adenocarcinoma Project aims to provide evidence-based guidance for the pathologic evaluation, classification, and reporting of endocervical adenocarcinoma. This review presents the recommendations pertaining to gross evaluation and intraoperative consultation of specimens obtained from patients in the setting of cervical cancer. The recommendations are the product of review of published peer-reviewed evidence, international guidelines and institutional grossing manuals, as well as deliberation within this working group. The discussion presented herein details the approach to the different specimen types encountered in practice: loop electrosurgical excision procedure, cone, trachelectomy, radical hysterectomy, pelvic exenteration, and lymphadenectomy specimens. Guidelines for intraoperative evaluation of trachelectomy and sentinel lymph node specimens are also addressed. Correlation with ISGyP recommendations on cancer staging, which appear as a separate review in this issue, is also included when appropriate. While conceived in the framework of endocervical adenocarcinoma, most of the discussion and recommendations can also be applied to other cervical malignancies.

Background During a fast-moving epidemic, timely monitoring of case counts and other key indicators of disease spread is critical to an effective public policy response. Methods We describe a nonparametric statistical method, originally applied to the reporting of AIDS cases in the 1980s, to estimate the distribution of reporting delays of confirmed COVID-19 cases in New York City during the late summer and early fall of 2020. Results During August 15–September 26, the estimated mean delay in reporting was 3.3 days, with 87% of cases reported by 5 days from diagnosis. Relying upon the estimated reporting-delay distribution, we projected COVID-19 incidence during the most recent 3 weeks as if each case had instead been reported on the same day that the underlying diagnostic test had been performed. Applying our delay-corrected estimates to case counts reported as of September 26, we projected a surge in new diagnoses that had already occurred but had yet to be reported. Our projections were consistent with counts of confirmed cases subsequently reported by November 7. Conclusion The projected estimate of recently diagnosed cases could have had an impact on timely policy decisions to tighten social distancing measures. While the recent advent of widespread rapid antigen testing has changed the diagnostic testing landscape considerably, delays in public reporting of SARS-CoV-2 case counts remain an important barrier to effective public health policy.

Summary At the end of 2019, the novel coronavirus infection outbroke in Wuhan, Hubei Province. On Feb. 2, 2020, Wuhan, as the worst-hit region, began to build “shelter hospital” rapidly to treat patients with mild illness. The shelter hospital has multiple functions such as emergency treatment, surgical treatment and clinical test, which can adapt to emergency medical rescue tasks. Based on the characteristics that shelter hospital only treats patients with mild illness, tests of shelter laboratory, including coronavirus nucleic acid detection, IgM/IgG antibody serology detection, monitoring and auxiliary diagnosis and/or a required blood routine, urine routine, C-reactive protein, calcitonin original, biochemical indicators (liver enzymes, myocardial enzymes, renal function, etc.) and blood coagulation function test etc, were used to provide important basis for the diagnosis and treatment of the disease. In order to ensure laboratory biosafety, it is necessary to first evaluate the harm level of various specimens. In the laboratory biosafety management, the harm level assessment of microorganisms is the core work of biosafety, which is of great significance to guarantee biosafety. As an emergency deployment affected by the environment, shelter laboratory must possess strong mobility. This paper will explore how to combine the biosafety model of traditional laboratory with the particularity of shelter laboratory to carry out effective work in response to the current epidemic.

Sentinel lymphadenectomy has replaced axillary lymph node dissection as a staging tool in early breast cancer. To be accepted as a standard of care, it had to pass successfully through a long journey which started in the early 1990s. We carried out a comprehensive literature review focusing on the journey of the use of sentinel lymph node biopsy (SLNB) in breast cancer from its start until its current station, including the variable clinical applications, the current debates, and the future issues. Adoption of sentinel lymph node biopsy as a standard axillary staging procedure was a marvelous trend that helped to decrease the complications of axillary dissection and significantly improve the quality of life of patients with breast cancer. Various mapping techniques can be used for SLN localization, rendering oncology centers that have variable capabilities and preparations able to perform the procedure. This applies to specimen processing techniques as well. Many debates faced the researchers throughout the SLNB journey. They are all explained in the current article, in addition to the ongoing trials and the future aspects of SLNB in breast cancer. Further research should be conducted to help resolve the clinical issues which are still debatable and to provide bases for improving the future trends which are progressing towards limiting the role of axillary dissection and axillary surgery to the minimum required level.

We discuss the role of the pathologist for MRI-targeted prostate biopsy with a focus on specimen processing, reporting of pathological findings and quality assurance in establishing a successful MRI-targeted biopsy programme. The authors discuss the current issues relevant to pathologists regarding MRI-targeted prostate biopsy. In addition, a brief review of the recently published literature was performed using an English literature search on PubMed with a focus on original investigations related to MRI-targeted prostate biopsy. Our search terms included the following: 'prostate cancer', 'pathology', 'histology', 'reporting', 'cores', 'imaging', 'MRI' and 'mpMRI'. Prostate multiparametric magnetic resonance imaging (mp-MRI) and MRI-targeted biopsy has been shown to improve the diagnosis of clinically significant prostatic adenocarcinoma and can affect the management of patients with prostate cancer. The current active surveillance guidelines were based on data from TRUS biopsies and not MRI-targeted biopsies. MRI-targeted biopsy acquires multiple cores of tissue from one or more suspicious lesions found on mp-MRI. The way in which multiple targeted core biopsies obtained from a single image-directed region of interest are analysed and reported can potentially alter the Gleason score and tumour burden as reported on biopsy, which could undoubtedly alter patient management. Pathologists play an important role in the reporting of MRI-targeted prostate biopsies. How we report prostate cancer grade and extent on these biopsies can influence patient management. In addition, the pathologist should be involved in the quality assurance for patients undergoing MRI-targeted prostate biopsy.

A successful breast core needle biopsy program provides numerous advantages for patients, radiologists, pathologists, surgeons, biomedical research, and the healthcare system. In order to obtain optimal results, it is essential that multiple healthcare providers and disciplines closely communicate and fully cooperate. The complexity of the process from the detection of a lesion, to biopsy, to ultimate outcome creates many opportunities for error. This chapter is a comprehensive guide for best practices for core needle biopsies. The chapter begins with an explanation of how imaging modalities (mammography, ultrasound, and MRI) detect breast abnormalities and how these findings correlate with pathologic lesions. Types of breast needle biopsies and the resulting specimens are then discussed in conjunction with information necessary to determine radiologic/pathologic correlation by both the radiologist and the pathologist. Recommendations for specimen handling from the removal by the radiologist to the creation of the glass slides by the histotechnologist are included. These topics are followed by optimal practices for identifying, excising, and examining a lesion previously sampled by needle biopsy. Throughout the chapter, commonly seen artifacts and possible pitfalls are discussed and illustrated. The chapter concludes with a review of rare cancer recurrences in needle tracks.

Diagnostic errors occur in the preanalytic, analytic, and postanalytic phases of specimen processing. Correlating clinical and imaging information with gross and microscopic findings is crucial to limit errors and unnecessary treatment. Herein, we report the case of a 54-year-old woman who presented with left breast bloody nipple discharge and subsequently underwent central duct excision. Pathology revealed a high-grade sarcoma. The patient presented to our institution for further management. Upon secondary pathology review and DNA fingerprinting analysis, the correct interpretation was rendered. Our case demonstrates the importance of clinical correlation and review of pathology slides prior to definitive therapy.

Circumferential resection margin (CRM) is essential for oncological quality assessment in rectal cancer surgery. CRM represents a surrogate parameter for oncological outcomes and is important for stratifying treatment strategies in Western nations. In Japan, the mesentery is removed for specimen processing in order to extract as many lymph nodes (LNs) as possible; consequently, CRM cannot be measured. Given the diversification of treatment strategies for rectal cancer, the lack of measurement of CRM to assess surgical outcomes is a crucial issue that must be resolved. Therefore, it is necessary to establish a method enabling measurement of CRM while enjoying the advantages of the Japanese method. In the method we developed, the mesentery is removed from the rectum more than 2 cm away from the tumor, and the vicinity of the tumor is circularized. It is necessary to investigate the usefulness of this method prospectively in a multi-center study.

Neoadjuvant chemotherapy is the standard of care for many women with early breast cancer, depending on the cancer's hormonal and genomic profile. Post-chemotherapy breast specimens are frequently encountered by the breast pathologist and present an interesting challenge in terms of specimen processing and reporting. We briefly review the literature on current recommendations for processing breast cancer specimens following neoadjuvant chemotherapy and present a case that emphasises the care needed in recognising reactive chemotherapy-related changes in non-neoplastic breast parenchyma to avoid over-diagnosing residual malignancy.

Child Health and Mortality Prevention Surveillance (CHAMPS) laboratories are employing a variety of laboratory methods to identify infectious agents contributing to deaths of children 100 real-time polymerase chain reaction (PCR) targets in total (30–45 per card depending on configuration). Multipathogen panels were configured by syndrome and customized to include pathogens of significance in young children within the regions where CHAMPS is conducted, including bacteria (57 targets covering 30 genera), viruses (48 targets covering 40 viruses), parasites (8 targets covering 8 organisms), and fungi (3 targets covering 3 organisms). The development and application of multiplex real-time PCR reactions to the TAC microfluidic platform increased the number of targets in each panel while maintaining assay efficiency and replicates for heightened sensitivity. These advances represent a substantial improvement in the utility of this technology for infectious disease diagnostics and surveillance. We optimized all aspects of the CHAMPS molecular laboratory testing workflow including nucleic acid extraction, quality assurance, and data management to ensure comprehensive molecular testing of specimens and high-quality data. Here we describe the development and implementation of multiplex TACs and associated laboratory protocols for specimen processing, testing, and data management at CHAMPS site laboratories., We developed and implemented custom TaqMan Array Cards for testing postmortem specimens for pathogens of significance in young children. All aspects of the CHAMPS molecular laboratory workflow were optimized to ensure generation and management of comprehensive and high-quality data.

Many preanalytical variables may affect the results of routine coagulation assays. While advances in laboratory instrumentation have partially addressed the laboratory's ability to recognize some of these variables, there remains an increased reliance on laboratory personnel to recognize the three potential areas where coagulation testing preanalytical issues may arise: (1) specimen collection (including patient selection), (2) specimen transportation and stability, and (3) specimen processing and storage. The purpose of this article is to identify the preanalytical variables associated with coagulation-related testing and provide laboratory practice recommendations in an effort to improve the quality of coagulation testing and accuracy of result reporting.

A simplified visual guide to the basic steps to obtain glass slides, from exiting the operation room all the way to the pathologist’s microscope.

Ureteroscopic biopsy is an integral part of diagnosis of urothelial carcinoma of the upper urinary tract. It can be a technical challenge, but diagnostic rates have improved remarkably with refinements in surgical technique and specimen processing. Cytology aids with diagnosis and other urinary biomarkers continue to evolve, which may help further stratify patients for treatment. The current literature on the ureteroscopic biopsy and role of urinary biomarkers is reviewed and summarized below.

BACKGROUND Endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) has emerged as a safe, efficacious alternative to fine needle aspiration (FNA) for tissue acquisition. EUS-FNB is reported to have higher diagnostic yield while preserving specimen tissue architecture. However, data on the optimal method of EUS-FNB specimen processing is limited. AIM To evaluate EUS-FNB with specimen processing as histology vs EUS-FNA cytology with regards to diagnostic yield and specimen adequacy. METHODS All EUS-FNA and EUS-FNB performed at our institution from July 1, 2016, to January 31, 2018, were retrospectively analyzed. We collected data on demographics, EUS findings, pathology, clinical outcomes, and procedural complications in two periods, July 2016 through March 2017, and April 2017 through January 2018, with predominant use of FNB in the second data collection time period. FNA specimens were processed as cytology with cell block technique and reviewed by a cytopathologist; FNB specimens were fixed in formalin, processed for histopathologic analysis and immunohistochemical staining, and reviewed by an anatomic pathologist. Final diagnosis was based on surgical pathology when available, repeat biopsy or imaging, and length of clinical follow up. RESULTS One hundred six EUS-FNA and EUS-FNB procedures were performed. FNA alone was performed in 17 patients; in 56 patients, FNB alone was done; and in 33 patients, both FNA and FNB were performed. For all indications, diagnostic yield was 47.1% (8/17) in FNA alone cases, 85.7% (48/56) in FNB alone cases, and 84.8% (28/33) in cases where both FNA and FNB were performed (P = 0.0039). Specimens were adequate for pathologic evaluation in 52.9% (9/17) of FNA alone cases, in 89.3% (50/56) of FNB alone cases, and 84.8% (28/33) in cases where FNA with FNB were performed (P = 0.0049). Tissue could not be aspirated for cytology in 10.0% (5/50) of cases where FNA was done, while in 3.4% (3/89) of FNB cases, tissue could not be obtained for histology. In patients who underwent FNA with FNB, there was a statistically significant difference in both specimen adequacy (P = 0.0455) and diagnostic yield (P = 0.0455) between the FNA and FNB specimens (processed correspondingly as cytology or histology). CONCLUSION EUS-FNB has a higher diagnostic yield and specimen adequacy than EUS-FNA. In our experience, specimen processing as histology may have contributed to the overall increased diagnostic yield of EUS-FNB.

Total laboratory automation (TLA) has the potential to reduce specimen processing time, improve standardization of cultures, and decrease turnaround time (TAT). The objective of this study was to perform a detailed interrogation of the impact of TLA implementation in all aspects of the workflow for routine culture of urine specimens. Using a detailed motion capture study, the time required for major steps of processing and result reporting were prospectively assessed for urine samples prior to (n = 215) and after (n = 203) implementation of the BD Kiestra TLA system. Specimens were plated on all shifts, but cultures were read only during the day shift for both time periods. Significant increases were noted in the time from receipt to inoculation (23.0 min versus 32.0 min, p

The safety evaluation of girth welds is an important issue for steel pipes. Current standards and studies all regard the weld as a uniform material, ignoring its inhomogeneity. In this paper, a specimen processing method for weld characteristic zones is proposed. Based on the natural morphology of the weld structure, specimens are accurately designed and processed for each characteristic zone. In addition, a testing method to determine the tensile properties in the characteristic zones of the weld is also proposed, solving the absence of weld mechanical properties in existing steel pipe safety evaluations. This method was used to test an X80 automatic girth weld, and the results showed that the tensile properties significantly differed between different characteristic zones of the girth weld. The inhomogeneity displayed in this weld demonstrates how a more detailed assessment of weld properties should be considered in practical engineering and safety evaluations.

The introduction of digital pathology to nephrology provides a platform for the development of new methodologies and protocols for visual, morphometric and computer-aided assessment of renal biopsies. Application of digital imaging to pathology made substantial progress over the past decade; it is now in use for education, clinical trials and translational research. Digital pathology evolved as a valuable tool to generate comprehensive structural information in digital form, a key prerequisite for achieving precision pathology for computational biology. The application of this new technology on an international scale is driving novel methods for collaborations, providing unique opportunities but also challenges. Standardization of methods needs to be rigorously evaluated and applied at each step, from specimen processing to scanning, uploading into digital repositories, morphologic, morphometric and computer-aided assessment, data collection and analysis. In this review, we discuss the status and opportunities created by the application of digital imaging to precision nephropathology, and present a vision for the near future.

Introduction/Objective A lack of standardized processes for laboratory handling of irretrievable body fluid specimens, such as cerebrospinal fluid, serous fluids, synovial fluids, and aspirates, can result in failures that put the patient at risk by delaying testing results and/or requiring specimen recollection. We noted increased patient safety issues with irretrievable specimens in our laboratory and implemented a process improvement plan to mitigate patient harm. Herein, we report our findings of this intervention. Methods A task force was organized with wide representation across the laboratory to design a new workflow for irretrievable specimens. Hospital Patient Safety Reporting data was used to identify flaws in the pre-analytical processes pre-intervention and to monitor effectiveness of process change, post-intervention. Our intervention consisted of developing a standardized pre-analytical process for both technical and non-technical staff that could be enforced through consistent and proper training, with well-defined responsibilities for each department involved including specimen processing, microbiology, hematology, and chemistry. Our process included a centralized sterile processing location within the Micro department as well as a standardized sample log in and sample distribution process that incorporated a chain of custody form. Results Pre-intervention, we had 23 patient safety reports during a 3-month period (5-10/month; average 8/month) on irretrievable specimens; post-intervention, we had 9 patient safety reports over a 5-month period (0-4/month; average 2/month). Pre-intervention, failures identified included inconsistent workflows and training among staff, the absence of established protocols, and inadequate communication. Post-intervention, failures were noted due to improper and inconsistent training (n=4) or deviation from the established procedure by staff members. These failures were investigated and addressed through retraining or corrective actions as needed. Conclusion Our data shows that the implementation of a standardized process within the laboratory significantly decreases patient safety events by improving testing turn-around-times and quality of results and by preventing the need for specimen recollections.

OBJECTIVES To investigate the benefits and challenges of introducing next generation chemistry and coagulation automation. METHODS We replaced the Roche modular preanalytic system attached to Roche Cobas 6000 analyzers with the Roche 8100 preanalytical line attached to the Roche Cobas 8000 and Stago STA R Max analyzers. The system included 2 add-on buffers (AOBs) for automated specimen archival and retrieval and primary-tube specimen processing. We measured turnaround time (TAT) from specimen receipt to result for chemistry and coagulation tests before, during, and after system implementation. TAT for add-on tests was also measured. RESULTS We completed the system implementation during a 17-month period using existing laboratory space. The TAT for chemistry, coagulation, and add-on tests decreased significantly (P

The field of laboratory medicine has increasingly moved toward automation. In a climate of rising costs, diminished resources, and personnel shortages, laboratory automation offers the potential to enhance work flow, improve efficiency, and decrease turnaround time (TAT). Following laboratory automation, a study looking at 2 academic centers reported >90% reduction in specimen processing errors, including errors in sorting, …

Currently, there is no established guidance on how to process and evaluate resected lung cancer specimens after neoadjuvant therapy in the setting of clinical trials and clinical practice. There is also a lack of precise definitions on the degree of pathologic response, including major pathologic response or complete pathologic response. For other cancers such as osteosarcoma and colorectal, breast, and esophageal carcinomas, there have been multiple studies investigating pathologic assessment of the effects of neoadjuvant therapy, including some detailed recommendations on how to handle these specimens. A comprehensive mapping approach to gross and histologic processing of osteosarcomas after induction therapy has been used for over 40 years. The purpose of this article is to outline detailed recommendations on how to process lung cancer resection specimens and to define pathologic response, including major pathologic response or complete pathologic response after neoadjuvant therapy. A standardized approach is recommended to assess the percentages of (1) viable tumor, (2) necrosis, and (3) stroma (including inflammation and fibrosis) with a total adding up to 100%. This is recommended for all systemic therapies, including chemotherapy, chemoradiation, molecular-targeted therapy, immunotherapy, or any future novel therapies yet to be discovered, whether administered alone or in combination. Specific issues may differ for certain therapies such as immunotherapy, but the grossing process should be similar, and the histologic evaluation should contain these basic elements. Standard pathologic response assessment should allow for comparisons between different therapies and correlations with disease-free survival and overall survival in ongoing and future trials. The International Association for the Study of Lung Cancer has an effort to collect such data from existing and future clinical trials. These recommendations are intended as guidance for clinical trials, although it is hoped they can be viewed as suggestion for good clinical practice outside of clinical trials, to improve consistency of pathologic assessment of treatment response.

This chapter reviews the peripheral nerve biopsy acquisition, specimen processing, and the interpretation of histopathological stains, semithin sections, and electron microscopy. Specific morphologic features that are commonly encountered in peripheral nerve biopsies are summarized, and their diagnostic implications are discussed.

Objective Complicated lymphatic anomalies (CLAs) are chronic, progressive, and debilitating conditions that share clinical features, yet key elements for optimal evaluation and management have not been established. We aimed to formulate expert opinion consensus-based guidelines for comprehensive evaluation of CLAs. Study design Patient support groups dedicated to CLAs organized an international conference for vascular anomaly experts from 16 specialties to address the objective. Participants received a set of questions before the meeting and reviewed the literature. Data extracted from international lymphatic anomaly registries were presented and the group separated for panel discussions during the conference. The recommendations achieving consensus within the panel were presented to the entire audience. Open debate occurred until majority approval was achieved. Results The expert group was composed of 52 physicians who defined the clinical elements required to evaluate and diagnose a CLA. The radiology panel established the preferred anatomical and functional imaging methods for diagnosis and the elements required to be described during interpretation. Two medical panels compiled the metabolic and hematologic tests at diagnosis and also recommended functional studies. The surgical group recommended precautions for biopsy and the pathology panel provided biopsy specimen processing guidelines. Conclusions Patients with CLAs require a comprehensive and targeted diagnostic plan for appropriate management, prevention of complications, and conservation of resources. As this population is managed by diverse medical and surgical specialties, we offer an expert multidisciplinary consensus-based opinion on the current literature and on data extracted from international lymphatic anomaly registries.

Tissue biopsy evaluation in the clinic is in need of quantitative disease markers for diagnosis and, most importantly, prognosis. Among the new technologies, quantitative phase imaging (QPI) has demonstrated promise for histopathology because it reveals intrinsic tissue nanoarchitecture through the refractive index. However, a vast majority of past QPI investigations have relied on imaging unstained tissues, which disrupts the established specimen processing. Here we present color spatial light interference microscopy (cSLIM) as a new whole-slide imaging modality that performs interferometric imaging on stained tissue, with a color detector array. As a result, cSLIM yields in a single scan both the intrinsic tissue phase map and the standard color bright-field image, familiar to the pathologist. Our results on 196 breast cancer patients indicate that cSLIM can provide stain-independent prognostic information from the alignment of collagen fibers in the tumor microenvironment. The effects of staining on the tissue phase maps were corrected by a mathematical normalization. These characteristics are likely to reduce barriers to clinical translation for the new cSLIM technology.

In underground tunnels, caverns or pillar goaf, the time-dependent deformation or failure of the rock or coal mass is a major safety concern, which affects the mechanical properties and stability of the coal and rock in the underground excavations. However, the damage surrounding rock or coal usually occurs from the time mining starts. This initial damage is rarely considered during the current creep tests used for coal. In the present study, an experimental specimen processing method to identify the initial damage to a coal deposit is suggested. The effect of the strain history on the deformation of coal samples with initial damage during multi-level loading triaxial compression creep tests was studied. The laboratory tests showed that the strain versus creep curve of the coal samples experiences three typical creep stages of deceleration creep in the early stage, constant velocity creep in the medium term and catastrophic accelerated creep in the later stage. With the increase in initial damage, it was observed the gradual decrease in total creep time, deviating stress of creep failure, stress threshold of accelerated creep and starting time of the volume expansion. When the initial damage value increased from 0.0 to 0.50, the deviating stress of creep failure, stress threshold of accelerated creep and starting time of the volume expansion of the coal decreased by 42.3%, 48.5% and 51.4%, respectively. The study is of great significance to conduct researches on the deformation, mechanical characteristics and long-term strength of coal pillar with initial damages under long-term pressure, and also provides insight into the underground excavations and the design of supports to the opneings under such disturbance.

Objectives: A proper examination of surgical specimens is fundamental in anatomic pathology (AP) education. However, the resources available to residents may not always be suitable for efficient skill acquisition. We propose a method to enhance AP education by introducing high-definition videos featuring methods for appropriate specimen handling, viewable on two-dimensional (2D) and stereoscopic three-dimensional (3D) platforms. Methods: A stereo camera system recorded the gross processing of commonly encountered specimens. Three edited videos, with instructional audio voiceovers, were experienced by nine junior residents in a crossover study to assess the effects of the exposure (2D vs 3D movie views) on self-reported physiologic symptoms. A questionnaire was used to analyze viewer acceptance. Results: All surveyed residents found the videos beneficial in preparation to examine a new specimen type. Viewer data suggest an improvement in specimen handling confidence and knowledge and enthusiasm toward 3D technology. None of the participants encountered significant motion sickness. Conclusions: Our novel method provides the foundation to create a robust teaching library. AP is inherently a visual discipline, and by building on the strengths of traditional teaching methods, our dynamic approach allows viewers to appreciate the procedural actions involved in specimen processing.

Background and study aims Endoscopic ultrasound-guided liver biopsy uses a 19-gauge (G) needle for parenchymal liver biopsies. We evaluated tissue yields with a 22G fine-needle biopsy (FNB) versus 19G FNA fine-needle aspirate (FNA) device. Patients and methods Biopsies were obtained from 20 patients using the 19G FNA and 22G FNB randomizing each in a cross-over fashion with a blinded outcome assessor. Tissue adequacy for histologic evaluation was the primary outcome, or the proportion of specimens obtaining pathologic diagnosis (portal structures ≥ 5 or length of the longest piece ≥ 15 mm). Additional secondary outcomes included portal and centrilobular inflammation/fibrosis, length of the longest piece, aggregate specimen length, and small ( 8 mm) fragments. Results were compared in a per needle basis. Patients with cirrhosis were excluded. Results Eighty biopsies (40 each 19G FNA and 22G FNB) were obtained. Tissue adequacy was greater for the 19G FNA (88 %) versus 22G FNB (68 %), (P = 0.03). There was no difference in total portal structures for the 19G FNA (7.4) and 22G FNB (6.1), (P = 0.28). There was no difference in pre-processing outcomes. After processing, length of the longest piece was higher for the 19G FNA (9.1 mm) versus 22G FNB (6.6 mm), (P = 0.02). More total post-processing small fragments 29.9 versus 20.7, (P = 0.01) and fewer large fragments 1.0 versus 0.4 for the 22G FNB (P = 0.01) were detected. Conclusions Tissue adequacy was higher for the 19G FNA versus 22G FNB needle. The 22G FNB needle produced samples more prone to fragmentation during specimen processing.

The rapid integration of molecular diagnostic assays into pathology has revolutionized the practice of diagnostic cytopathology by providing a genomic dimension to morphologic diagnoses while providing predictive, prognostic, and therapeutic information for patient care. The versatility of cytology specimen preparations provides a variety of options for performing molecular assays, as long as the pre-analytic aspects of specimen processing and handling are optimized and the tests are appropriately validated. With the increasing use of liquid biopsy assays, several investigators are exploring molecular testing using tumor-derived cell-free DNA (cfDNA) in cytology samples. In addition, cytopathologists are discovering ways to better utilize cytology specimens by repurposing previously discarded samples to provide additional genomic information in cases that would otherwise warrant an additional biopsy. These novel applications of molecular assays in cytology have expanded the role of cytopathology in routine patient care. Cytopathologists will need to continue to evolve with the changing landscape of molecular medicine, to adopt and optimize new technology, and to integrate molecular methods into routine cytopathology practice.

The Children’s Brain Tumor Tissue Consortium (CBTTC) is a multi-institutional collaborative research program dedicated to accelerating pediatric brain tumor research. Tumor specimens collected by CBTTC undergo multidimensional tumor analysis including genomic, transcriptomic and proteomic data generation, providing freely available data for researchers worldwide. Moreover, CBTTC advances pediatric research efforts by generating cell lines and and patient-derived xenografts (PDX) providing these freely available materials for researchers worldwide. High-grade gliomas (HGG) in children is the most prevalent among brain tumors with a dismal prognosis. Preclinical testing has been limited due to lack of pediatric specific HGG in vitro and in vivo models. Here we present a cohort of pediatric HGG cell lines developed within the CBTTC. The cells were derived from 10 subjects from fresh or frozen tumor tissues and generated in different culture conditions. Results include the cells’ basic molecular characteristics and tumor formation in vivo, which presents valuable information for preclinical studies. We also report how our cell culture conditions affect the morphology, growth and genetic makeup of developed tumor cell lines. These results can intersect with tumor molecular profiling to provide a transparent view of cell line utility for cell biology and drug development studies. This project serves as an example of CBTTC’s pipeline for cell line development, and brings important insights for the processes of brain tumor specimen derived tool generation.

Ancillary testing in cytopathology has grown dramatically over the past decade, enhancing the clinical value of cytology specimens obtained via minimally invasive methods. However, a complex testing landscape brings with it new and emerging risks to patient safety. Recognition of complicated systems issues as well as shared responsibility in process ownership can help to minimize safety risks. Because pre-analytic factors account for the majority of errors in pathology, attention to operational steps (test ordering, specimen collection, specimen transport, specimen accessioning, and specimen processing) is critical for successful quality improvement programs. With increasing technical costs and complexity of many ancillary molecular tests, a growing trend toward send-out testing to centralized reference laboratories poses additional patient safety risks. Given these new realities in cytopathology ancillary testing, a collaborative, team-based approach with all process stakeholders is needed to improve pre-analytic processes, reduce error risk, and enhance patient safety.

The scarcity of specific submission protocols for nail unit biopsies presents many challenges for appropriate specimen processing. Many nail biopsies are received fragmented or without orientation, often resulting in less-than-ideal tissue embedding and poor histologic sections, which are difficult to interpret. Methods are described for proper nail matrix/bed biopsy and plate submission that incorporate aspects of previous submission protocols and include inking the biopsy specimen along with submitting the tissue on a drawing of the nail. Also described is a technique for maintaining adherence of nail plate to glass slides, a chronic challenge in the laboratory.

The automation of specimen processing and culture workup has rapidly emerged in clinical microbiology laboratories throughout the world and more recently in the United States. While many U.S. laboratories have implemented some form of automated specimen processing and some have begun performing digital plate reading, automated colony analysis is just beginning to be utilized clinically. In this issue of the Journal of Clinical Microbiology , M. L. Faron et al. (J Clin Microbiol 54:2470–2475, 2016, http://dx.doi.org/10.1128/JCM.01040-16 ) report the results of their evaluation of the performance of the WASPLab Chromogenic Detection Module (CDM) for categorizing chromogenic agar plates as negative or “nonnegative” for vancomycin-resistant enterococci (VRE). Their major finding was 100% sensitivity for detection of “nonnegative” specimens using CDM compared to manual methods for specimens plated on two different types of VRE chromogenic agar plates. Additionally, utilization of digital plate reading in conjunction with automated colony analysis was predicted to result in significant savings based on greatly reduced labor costs.

Background Although on-site cytopathology services have a significant impact on efficiency and accuracy of EUS-guided FNA (EUS-FNA), the availability of this service is variable. Objective To evaluate the impact of an intensive 2-day training program to educate endosonographers in EUS-related cytopathology. Design Pilot study. Setting Tertiary care medical center. Subjects Six endosonographers (5 male, median age, 35 years) with minimal previous cytopathology exposure comprised the study cohort. Methods Pre- and posttraining testing was administered. Training commenced with a cytopathology tutorial focusing on 4 performance measures: specimen adequacy, sample interpretation, specimen processing, and preliminary diagnosis. Eight live EUS-FNA cases were then performed, and study participants independently completed 4 questions based on performance measures for each case. The ability to independently smear and stain slides and operate a microscope was additionally assessed after a hands-on tutorial. Main Outcome Measurements Comparison of pretraining and posttraining scores, improvement in performance measures for live cases, and ability to independently handle specimens and operate a microscope. Results Compared with pretraining, mean posttraining test scores improved by 63% from 48 to 78 out of 100. Mean live case performance score was 95%. Performances improved from 89% on day 1 to 100% on day 2. After training, all endosonographers could independently smear/stain slides and operate a microscope. Limitations Long-term impact is unclear. Conclusions An intensive 2-day program was effective in training endosonographers in the basics of EUS-related cytopathology. Incorporating basic cytopathology in EUS fellowship curriculum will likely improve diagnostic performance of tissue acquisition procedures.

The Wisconsin State Laboratory of Hygiene challenged Wisconsin laboratories to examine their biosafety practices and improve their culture of biosafety. One hundred three clinical and public health laboratories completed a questionnaire-based, microbiology-focused biosafety risk assessment. Greater than 96% of the respondents performed activities related to specimen processing, direct microscopic examination, and rapid nonmolecular testing, while approximately 60% performed culture interpretation. Although they are important to the assessment of risk, data specific to patient occupation, symptoms, and travel history were often unavailable to the laboratory and, therefore, less contributory to a microbiology-focused biosafety risk assessment than information on the specimen source and test requisition. Over 88% of the respondents complied with more than three-quarters of the mitigation control measures listed in the survey. Facility assessment revealed that subsets of laboratories that claim biosafety level 1, 2, or 3 status did not possess all of the biosafety elements considered minimally standard for their respective classifications. Many laboratories reported being able to quickly correct the minor deficiencies identified. Task assessment identified deficiencies that trended higher within the general (not microbiology-specific) laboratory for core activities, such as packaging and shipping, direct microscopic examination, and culture modalities solely involving screens for organism growth. For traditional microbiology departments, opportunities for improvement in the cultivation and management of highly infectious agents, such as acid-fast bacilli and systemic fungi, were revealed. These results derived from a survey of a large cohort of small- and large-scale laboratories suggest the necessity for continued microbiology-based understanding of biosafety practices, vigilance toward biosafety, and enforcement of biosafety practices throughout the laboratory setting.

Background Comparative data on different self-collection methods is limited. Objectives To assess the impact of hrHPV testing of two self-collection devices for detection of cervical carcinoma and high-grade lesions. Study design Three hundred ten patients collected two cervicovaginal specimens using a brush (Evalyn®Brush) and a swab (FLOQSwabs™), and filled a questionnaire at home. Then, a physician at the clinic took a cervical specimen into PreservCyt® buffer for hrHPV testing and cytology. All specimens were tested using Anyplex™ II HPV28, Cobas® 4800 HPV Test and Xpert®HPV. Results Performance comparison included 45 cervical carcinomas and 187 patients with premalignant lesions. Compared to the physician-specimen, hrHPV testing of Evalyn®Brush showed non-inferior sensitivity for CIN3+ (relative sensitivity of Anyplex™ 0.99; Cobas® 0.96; Xpert®HPV 0.97) while hrHPV testing of FLOQSwabs™ showed inferior sensitivity (relative sensitivity of Anyplex™ 0.91; Cobas® 0.92; Xpert®HPV 0.93). Similar results were observed for invasive carcinomas albeit that FLOQSwabs™ was statistically non-inferior to the physician-specimen. Self-collection by either Evalyn®Brush or FLOQSwabs™ was more sensitive for CIN3+ than LSIL or worse cytology. Significant decrease in sensitivity for CIN3+ were observed for FLOQSwabs™ when specimens were preprocessed for hrHPV testing after 28 days. Both devices were well accepted, but patients considered Evalyn®Brush easier and more comfortable than FLOQSwabs™. Conclusions Self-collection is comparable to current screening practice for detecting cervical carcinoma and CIN3+ but device and specimen processing effects exist. Only validated procedure including collection device, hrHPV assay and specimen preparation should be used.

Automated chemistry laboratories dependent on robotic processes are the standard in both academic and large community hospital settings. Diagnostic microbiology manufacturers are betting that robotics will be used for specimen processing, plate reading, and organism identification in the near future. These systems are highly complex and have large footprints and hefty price tags. However, they are touted as being more efficient, rapid, and accurate than standard processes. Certain features, such as image collection, are highly innovative. Hospital administrators may be swayed to institute these new systems because of the promise of the need for fewer skilled workers, higher throughput, and greater efficiency. They also may be swayed by the fact that workers with the requisite clinical microbiology skills are becoming more difficult to find, and this technology should allow fewer skilled workers to handle larger numbers of cultures. In this Point-Counterpoint, Nate Ledeboer, Medical Director, Clinical Microbiology and Molecular Diagnostics, Dynacare Laboratories, and Froedtert Hospital, Milwaukee, WI, will explain why he believes that this approach will become widespread, while Steve Dallas of the University of Texas Health Science Center San Antonio explains why he thinks that this automation may not become widely used.

Modern electronic health record systems (EHRS) reportedly offer advantages including improved quality, error prevention, cost reduction, and increased efficiency. This project reviewed the impact on specimen turnaround times (TAT) and percent compliance for specimens processed in a STAT laboratory after implementation of an upgraded EHRS.Before EHRS implementation, laboratory personnel received instruction and training for specimen processing. One laboratory member per shift received additional training. TAT and percent compliance data sampling occurred 4 times monthly for 13 months post-conversion and were compared with the mean of data collected for 3 months pre-conversion. Percent compliance was gauged using a benchmark of reporting 95% of all specimens within 7 min from receipt.Control charts were constructed for TAT and percent compliance with control limits set at 2 SD and applied continuously through the data collection period. TAT recovered to pre-conversion levels by the 6th month post-conversion. Percent compliance consistently returned to pre-conversion levels by the 10th month post-conversion. Statistical analyses revealed the TAT were significantly longer for 3 months post-conversion (P.001) compared with pre-conversion levels. Statistical significance was not observed for subsequent groups. Percent compliance results were significantly lower for 6 months post-conversion (P.001). Statistical significance was not observed for subsequent groups.Extensive efforts were made to train and prepare personnel for challenges expected after the EHRS upgrade. Specific causes identified with the upgraded EHRS included multiple issues involving personnel and the EHRS. These data suggest that system and user issues contributed to delays in returning to pre-conversion TAT and percent compliance levels following the upgrade in the EHRS.

The number of lymph nodes retrieved from the specimen may be a surrogate measure of the adequacy of extensive colon cancer surgery, but many variables may influence the total lymph node yield of any specimen. We examined which variables would be influential both for negative and positive node sampling.The combined results from 428 patients from three hospitals A to C treated in 2007-2009 with single colon cancers having R0 segmental resections were analysed. The surgical technique and pathology staining methods were slightly different between the hospitals.The mean number of lymph nodes was 15.8 (range 1-60). Twelve or more lymph nodes were harvested in 78% of the specimens. In the multivariate Poisson regression analysis of all TNM stages, the factors associated with the total lymph node harvest were age, pathology handling, tumour location and size (p < 0.001), whereas for TNM stage III alone the pathology handling (p < 0.001) and a radical operating technique (p = 0.003) were highly significant. The total number of lymph nodes was the only significant factor for the number of positive lymph nodes (Posln) according to the multivariate negative regression analysis (p = 0.02) but the analysis of the lymph node ratio (LNR) detected no statistically significant variable.Several factors, and especially the specimen processing technique, were important for the total number of harvested lymph nodes. The number of Posln varied between segments and increased with the total number of harvested lymph nodes, but for LNR no variable was important. LNR seemed to abolish the combined effect of tumour location and the total lymph node yield in prognosis assessment.

BACKGROUND Timely treatment of Chlamydia trachomatis infection reduces complications and onward transmission. We assessed client, process, and clinic factors associated with treatment delays at sexual health clinics in New South Wales, Australia. METHODS A retrospective review of 450 consecutive clients with positive chlamydia results (not treated at the time of the consultation) was undertaken at 6 clinics (1 urban, 3 regional, and 2 remote) from October 2013. Mean and median times to treatment were calculated, overall and stratified by process steps and clinic location. RESULTS Nearly all clients (446, 99%) were treated, with 398 (88%) treated in ≤14 days and 277 (62%) in ≤7 days. The mean time-to-treatment was 22 days at remote clinics, 13 days at regional and 8 days at the urban clinic (P < 0.001). Mean time between the laboratory receipt of specimen and reporting of result was 4.9 in the remote clinics, 4.1 in the regional, and 2.7 days in the urban clinic (P < 0.001); and the mean time between the clinician receiving the result until client treatment was15, 5, and 3 days (P < 0.01), respectively. CONCLUSIONS At participating clinics, treatment uptake was high, however treatment delays were greater with increasing remoteness. Strategies to reduce the time-to-treatment should be explored such as point-of-care testing, faster specimen processing, dedicated clinical time to follow up recalls, SMS results to clients, and taking treatment out to clients.

Background: Laboratories today face increasing pressure to automate operations due to increasing workloads and the need to reduce expenditure. Few studies to date have focussed on the laboratory automation of preanalytical coagulation specimen processing. In the present study, we examined whether a clinical chemistry automation protocol meets the preanalytical requirements for the analyses of coagulation. Methods: During the implementation of laboratory automation, we began to operate a pre- and postanalytical automation system. The preanalytical unit processes blood specimens for chemistry, immunology and coagulation by automated specimen processing. As the production of platelet-poor plasma is highly dependent on optimal centrifugation, we examined specimen handling under different centrifugation conditions in order to produce optimal platelet deficient plasma specimens. To this end, manually processed models centrifuged at 1500 g for 5 and 20 min were compared to an automated centrifugation model at 3000 g for 7 min. Results: For analytical assays that are performed frequently enough to be targets for full automation, Passing-Bablok regression analysis showed close agreement between different centrifugation methods, with a correlation coefficient between 0.98 and 0.99 and a bias between –5% and +6%. For seldom performed assays that do not mandate full automation, the Passing-Bablok regression analysis showed acceptable to poor agreement between different centrifugation methods. Conclusions: A full automation solution is suitable and can be recommended for frequent haemostasis testing.

Substantive and significant advances have been made in the last two decades in the characterization of human immunodeficiency virus (HIV) infections using molecular techniques. These advances include the use of real-time measurements, isothermal amplification, the inclusion of internal quality assurance protocols, device miniaturization and the automation of specimen processing. The result has been a significant increase in the availability of results to a high level of accuracy and quality. Molecular assays are currently widely used for diagnostics, antiretroviral monitoring and drug resistance characterization in developed countries. Simple and cost-effective point-of-care versions are also being vigorously developed with the eventual goal of providing timely healthcare services to patients residing in remote areas and those in resource-constrained countries. In this review, we discuss the evolution of these molecular technologies, not only in the context of the virus, but also in the context of tests focused on human genomics and transcriptomics.

This article provides a protocol for the systematic approach to the technique of Mohs micrographic surgery. Each step, from tumor excision and tissue mapping, to specimen processing and histologic interpretation, through wound closure and postoperative management, is covered. The advantages of Mohs surgery over other treatment modalities are observed histologic margin control, superior cure rates, and maximal tissue-sparing potential. The increased preservation of normal tissue leads to smaller surgical defects, optimal reconstructive results, and diminished risk of poor surgical outcomes. Overall, the risks of the procedure are few, the benefits numerous, and the outcomes worth the time and effort spent in learning the technique.

BACKGROUND There has been little written concerning the use of frozen sections to diagnose skin lesions. OBJECTIVE To compare the concordance between frozen and permanent sections of the same diagnostic skin biopsy specimen. METHODS AND MATERIALS Over 3 months, all non-melanocytic skin lesions that were biopsied in a skin cancer clinic were examined using frozen and permanent sections. Diagnoses from a dermatologist and dermatopathologist were recorded for each specimen and later examined for concordance. RESULTS There was rare (0.5% of specimens) disagreement recorded between interpretations of the dermatologist and dermatopathologist. Permanent and frozen section pathology agreed with one another 90.4% of the time. Specimen processing was the most probable cause of discordance. Most discordance was not clinically relevant, although the patient was clinically affected in 35 of 2009 specimens (1.7%). CONCLUSION Although there is a high concordance rate between diagnostic frozen and permanent sections, there are significant quality assurance and patient care advantages to following up initial diagnostic frozen sections with permanent sections of the same specimen.

Microbiological diagnosis of bacterial lower respiratory tract infections has relevant limitations and related controversy, depending on the clinical setting and diagnostic methods used, and its value is contingent on an accurate clinical diagnosis and previous antimicrobial therapy. The limitations reside in a low diagnostic yield of the causative agent and the difficulty of determining the clinical significance of the agents recovered. This report examines the current microbiological diagnostic yield of the main clinical entities and etiological agents, indications for invasive or non-invasive specimen collection procedures, and proper specimen processing and culture in the appropriate media. Criteria regarding specimen suitability and indications for quantitative cultures are established. Criteria for evaluating the results are provided, and the current fast diagnostic techniques are described.

To optimize Buruli ulcer (BU) microscopic diagnosis, we compared two smear preparation methods from tissue specimens: smears made with tissue suspension after grinding and smears made directly with unground tissue. We also compared two smear staining methods: auramine and Ziehl-Neelsen (ZN). IS 2404-PCR was used as reference method. One hundred and thirty-one surgical tissue specimens from patients suspected of having BU were analyzed. Both smear preparation methods and both staining methods were equivalent in any combination. Thus we recommend ZN stained smears of unground tissue for peripheral treatment centres.

Publisher Summary This chapter focuses on various aspects of running a clinical laboratory. It mentions that clinical laboratory testing should follow regulations and comply with standards. The concerns about test quality led to the Clinical Laboratory Improvement Amendments of 1988 (CLIA’88) regulations that oversees all aspects of testing in most clinical laboratories. According to CLIA, a clinical laboratory must undergo inspection every two years and must engage in proficiency testing for every analyte for which testing is offered. The Health Insurance Portability and Accountability Act (HIPAA) include provisions for ensuring the privacy of patient information including test results. An issue in molecular genetics laboratories is mentioned to be the minimization of risk of contamination by amplicons from polymerase chain reaction (PCR). The traditional applications of radioactivity can be performed by non-radioactive methods and long range PCR can replace some southern blot applications. The clinical testing process is described and involves three phase: pre-analytical, analytical and post-analytical. The sample handling, specimen handling and specimen processing are further discussed.