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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.

Introducing a sensitive and specific peripheral blood flow cytometric assay for Sézary syndrome and mycosis fungoides (SS/MF) requires careful selection of assay design characteristics, and translation into a laboratory developed assay through development/optimization, validation, and continual quality monitoring. As outlined in a previous article in this series, the recommended design characteristics of this assay include at a minimum, evaluation of CD7, CD3, CD4, CD8, CD26, and CD45, analyzed simultaneously, requiring at least a 6 color flow cytometry system, with both quantitative and qualitative components. This article provides guidance from an international group of cytometry specialists in implementing an assay to those design specifications, outlining specific considerations, and best practices. Key points presented in detail are: (a) Pre-analytic components (reagents, specimen processing, and acquisition) must be optimized to: (i) identify and characterize an abnormal population of T-cells (qualitative component) and (ii) quantitate the abnormal population (semi/quasi-quantitative component). (b)Analytic components (instrument set-up/acquisition/analysis strategy and interpretation) must be optimized for the identification of SS/MF populations, which can vary widely in phenotype. Comparison with expert laboratories is strongly encouraged in order to establish competency. (c) Assay performance must be validated and documented through a validation plan and report, which covers both qualitative and semi/quasi-quantitative assay components (example template provided). (d) Ongoing assay-specific quality monitoring should be performed to ensure consistency.

A remote collection of biofluid specimens such as blood and urine remains a great challenge due to the requirement of continuous refrigeration. Without proper temperature regulation, the rapid degradation of analytical targets in the specimen may compromise the accuracy and reliability of the testing results. In this study, we develop porous superabsorbent polymer (PSAP) beads for fast and self-driven "microfiltration" of biofluid samples. This treatment effectively separates small analytical targets (e.g., glucose, catalase, and bacteriophage) and large undesired components (e.g., bacteria and blood cells) in the biofluids by capturing the former inside and excluding the latter outside the PSAP beads. We have successfully demonstrated that this treatment can reduce sample volume, self-aliquot the liquid sample, avoid microbial contamination, separate plasma from blood cells, stabilize target species inside the beads, and enable long-term storage at room temperature. Potential practical applications of this technology can provide an alternative sample collection and storage approach for medically underserved areas.

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.

Context.— Workflow mapping is a tool used to characterize operational processes throughout most industries and to identify non–value-added activities. Objective.— To develop a set of workflow mapping tools to compare the sequence and timing of activities, including waiting steps, used by clinical laboratories to process specimens during the preanalytic testing phase. Design.— Laboratories enrolled in this College of American Pathologists Q-Probes study created workflow maps detailing the steps they used to process specimens from the time of sample arrival in the laboratory to the time of sample delivery to chemistry analyzers. Enrollees recorded the sequence and types of steps involved in specimen processing and the time needed to complete each step. Results.— Institution average total specimen processing times (SPTs) and the number of steps required to prepare samples varied widely among institutions. Waiting steps, that is, steps requiring specimens to wait before advancing to the next process step, and specimen centrifugation consumed the greatest amount of processing times for both routine and STAT testing. Routine and STAT testing SPTs were shorter at institutions that used rapid centrifuges to prepare samples. Specimen processes requiring more sample waiting steps and computer entry steps had longer aggregate total process times than those with fewer such steps. Conclusions.— Aggregate specimen processing times may be shortened by reducing the number of steps involving sample waiting and computer entry activities. Rapid centrifugation is likely to reduce overall average institutional SPTs.

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.

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.

The purpose of this ISRM Suggested Method is to introduce a guideline on determining deformation and failure characteristics of rocks subjected to true triaxial compression on different stress path. The true triaxial testing apparatus was reviewed by means of the function and engineering application. Some key techniques, such as stress and strain measurements, and reduction of end effect between specimen and metal platens, preventing metal platens interference, were stated and suggested in detail. Methodology of specimen processing, specimen shape, and testing procedure are characterized. There is an explanation of the experimental data processing on stress–strain curves, strength, and fracture mode.

Candida tropicalis is an increasingly opportunistic pathogen that causes serious invasive candidiasis threatening a patient’s life. Traditional methods to detect C. tropicalis infection depends on time-consuming, culture-based gold-standard methods. So, we sought to establish a new method that could detect target pathogens quickly, accurately, and straightforwardly. Herein, a combination of multiple cross displacement amplification (MCDA) and lateral flow biosensors (LFB) was employed to detect C. tropicalis. In the MCDA system, 10 primers were designed to identify the specific genes of C. tropicalis and amplify the genes in an isothermal amplification device. Then, MCDA amplification reaction products could be identified visibly by color change, and all the amplification products would be tested by LFB with no special equipment. The results demonstrated that the optimal reaction condition of C. tropicalis-MCDA assay was 64°C within 30 min, and only 10 fg DNA was required in each reaction. No cross-reaction was found between C. tropicalis strains and non-C. tropicalis strains. For 300 sputum samples, the results showed that MCDA-LFB assay could rapidly and successfully detect all of the C. tropicalis-positive (28/300) samples detected by the gold-standard method. The entire procedure, including specimen processing (40 min), isothermal reaction (30 min) and result reporting (within 2 min), could be completed within 75 min. Briefly, the study results demonstrated that the detection ability of C. tropicalis-MCDA-LFB assay was better than culture methods with more simplicity, rapidity, sensitivity and specificity. Hence, MCDA-LFB strategy is an effective tool to rapidly detect C. tropicalis in clinical samples, especially in resource-poor areas.

Context.— Precision therapies for patients with driver mutations can offer deep and durable responses that correlate with diagnosis, metastasis prognosis, and improvement in survival. The use of such targeted therapies will continue to increase, pushing us to change our traditional approaches. We needed to search for new tools to effectively integrate technological advancements into our practices because of their capability to improve the efficiency and accuracy of our diagnostic and treatment approaches. Perhaps nothing is as relevant as identifying and implementing new workflows for processing pathologic specimens and for improving communication of critical laboratory information to and from clinicians for appropriate care of patients in an efficient and timely manner. Objectives.— To define the gold standard in delivering the best care for patients, to identify gaps in the process, and to identify potential solutions that would improve our process, including gaps related to knowledge, skills, attitudes, and practices. Design.— We assembled a multidisciplinary team to systematically perform a gap analysis study to clarify the discrepancy between the current reality in pathology specimen processing and the desired optimal situation to deliver the results intended for patient care. Results.— A practical collaborative workflow for specimen management that seeks the cooperation of stakeholders in each medical discipline to provide guidelines in specimen collection, delivery, processing, and reporting of results with the ultimate goal of improving patient outcomes is provided. Conclusions.— New tools are required to effectively integrate data-driven approaches in specimen processing to meet the new demands.

In this chapter, the author describes the quality control in flow cytometry. It consists of two parts: Internal quality control (IQC) and external quality assessment (EQA). The internal quality control includes specimen integrity, specimen processing, antibody, reagent, and instrument control. External Quality Assessment of flow cytometry procedure provides a snapshot of the performance. The specimens are sent at a few monthly intervals to the laboratories. The final data generated in the laboratory help to compare the performance of different laboratories.

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.

Summary The term metagenomics refers to the use of sequencing methods to simultaneously identify genomic material from all organisms present in a sample, with the advantage of greater taxonomic resolution than culture or other methods. Applications include pathogen detection and discovery, species characterisation, antimicrobial resistance detection, virulence profiling, and study of the microbiome and microecological factors affecting health. However, metagenomics involves complex and multistep processes and there are important technical and methodological challenges that require careful consideration to support valid inference. We co-ordinated a multidisciplinary, international expert group to establish reporting guidelines that address specimen processing, nucleic acid extraction, sequencing platforms, bioinformatics considerations, quality assurance, limits of detection, power and sample size, confirmatory testing, causality criteria, cost, and ethical issues. The guidance recognises that metagenomics research requires pragmatism and caution in interpretation, and that this field is rapidly evolving.

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

Biologists frequently sort specimen-rich samples to species. This process is daunting when based on morphology, and disadvantageous if performed using molecular methods that destroy vouchers (e.g., metabarcoding). An alternative is barcoding every specimen in a bulk sample and then presorting the specimens using DNA barcodes, thus mitigating downstream morphological work on presorted units. Such a "reverse workflow" is too expensive using Sanger sequencing, but we here demonstrate that is feasible with an next-generation sequencing (NGS) barcoding pipeline that allows for cost-effective high-throughput generation of short specimen-specific barcodes (313 bp of COI; laboratory cost

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.

Rapid and accurate detection and identification of microbial pathogens causing urinary tract infections allow prompt and specific treatment. We optimized specimen processing to maximize the limit of detection (LOD) by matrix-assisted laser desorption ionization–time of flight mass spectrometry (MALDI-TOF MS) and evaluated the capacity of combination of MALDI-TOF MS and urine analysis (UA) for direct detection and identification of bacterial pathogens from urine samples. The optimal volumes of processed urine, formic acid/acetonitrile, and supernatant spotted onto the target plate were 15 ml, 3 μl, and 3 μl, respectively, yielding a LOD of 1.0 × 10 5 CFU/ml. Among a total of 1,167 urine specimens collected from three hospital centers, 612 (52.4%) and 351 (30.1%) were, respectively, positive by UA and urine culture. Compared with a reference method comprised of urine culture and 16S rRNA gene sequencing, the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of MALDI-TOF MS alone and MALDI-TOF MS coupled with UA were 86.6% versus 93.4% (χ 2 = 8.93; P < 0.01), 91.5% versus 96.3% (χ 2 = 7.06; P < 0.01), 81.5% versus 96.4% (χ 2 = 37.32; P < 0.01), and 94.1% versus 93.1% (χ 2 = 0.40; P > 0.05), respectively. No significant performance differences were revealed among the three sites, while specificity and NPV of MALDI-TOF MS for males were significantly higher than those for females (specificity, 94.3% versus 77.3%, χ 2 = 44.90, P < 0.01; NPV, 95.5% versus 86.1%, χ 2 = 18.85, P < 0.01). Our results indicated that the optimization of specimen processing significantly enhanced analytical sensitivity and that the combination of UA and MALDI-TOF MS provided an accurate and rapid detection and identification of bacterial pathogens directly from urine.

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

Introduction Sputum specimen decontamination steps are essential due to the presence of other saprophytic and infectious organisms. However, they negatively affect the mycobacterial recovery. In addition, little is known about the Mycobacterium tuberculosis killing efficacy of the PANTA (polymyxin-B, amphotericin-B, nalidixic acid, trimethoprim, azilocillin) antibiotics. Moreover, M. tuberculosis can be present in more than one metabolic population, but the effect of different growth characteristics on the mycobacterial growth indicator tube (MGIT) based time-to-positive (TTP) is not well studied. Methods We performed-(1) experiments using the solid agar and MGIT method to determine the effect of the NALC-NaOH decontamination method, (2) concentration-response studies with each individual antibiotic in the PANTA, and (3) the effect of the M. tuberculosis metabolic population on the TTP. TTP was recorded using the Epicenter software and exponential growth equation was used to calculate the doubling time of the bacteria, whereas, CFU/mL was analyzed using the Inhibitory Sigmoid Emax model for each antibiotic. Results Decontamination resulted in 4.36+0.13 log10 CFU/mL difference in cultures treated with NALC-NaOH versus no decontamination process and the limit of detection decreased from 1.47 log10 CFU/mL to the 0.42 log10 CFU/mL following NALC-NaOH treatment. PANTA at currently used antibiotic concentrations, did not had negative effect on mycobacterial recovery. Exponential growth model estimated doubling time for the log-phase growth M. tuberculosis as 2.04 days, for the semi-dormant bacilli as 2.80 days, and 6.37 days for the anaerobic cultures. Conclusion Specimen decontamination method negatively affect the laboratory diagnosis of M. tuberculosis, polymyxin-B and nalidixic acid have anti-tuberculosis efficacy at high concentrations, and the doubling time of different metabolic population should be considered when deciding the time-in-protocol for the MGIT system.

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.