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The goal of this Views and Interviews series was to bring together the thought leaders in the field and envision what the laboratory will look like in the future. This consensus piece strives to take the thoughts of those leaders and develop themes and concepts that will be significant in the laboratory in the coming years., (Copyright © 2021 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)

The in vitro fertilization and andrology laboratories are at the center of assisted reproductive technologies and the place where technicians and embryologists manipulate gametes and preimplantation-stage embryos with the goal of achieving the best embryo for transfer. Through the years, these laboratories have seen developments in technique, technology, and testing. The goal of this Views and Interviews series is to bring together the thought leaders in the field and envision what the laboratories will look like in the next 10 years., (Copyright © 2021 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)

The aim of this article is to gather 9 thought leaders and their team members to present their ideas about the future of in vitro fertilization and the andrology laboratory. Although we have seen much progress and innovation in the laboratory over the years, there is still much to come, and this article looks at what these leaders think will be important in the future development of technology and processes in the laboratory., (Copyright © 2021 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)

Context.—: Coronavirus disease 2019 (COVID-19) changed the dynamics of health care delivery, shifting patient priorities and deferring care perceived as less urgent. Delayed or eliminated care may place patients at risk for adverse outcomes., Objective.—: To identify opportunities for laboratory test stewardship to close potential gaps in care created by the COVID-19 pandemic., Design.—: The study was a retrospective time series design examining laboratory services received before and during the COVID-19 pandemic at a large metropolitan health system serving women and children., Results.—: Laboratory test volumes displayed 3 distinct patterns: (1) a decrease during state lockdown, followed by near-complete or complete recovery; (2) no change; and (3) a persistent decrease. Tests that diagnose or monitor chronic illness recovered only partially. For example, hemoglobin A1c initially declined 80% (from 2232 for April 2019 to 452 for April 2020), and there was a sustained 16% drop (28-day daily average 117 at August 30, 2019, to 98 at August 30, 2020) 4 months later. Blood lead dropped 39% (from 2158 for April 2019 to 1314 for April 2020) and remained 23% lower after 4 months., Conclusions.—: The pandemic has taken a toll on patients, practitioners, and health systems. Laboratory professionals have access to data that can provide insight into clinical practice and identify pandemic-related gaps in care. During the pandemic, the biggest patient threat is underuse, particularly among tests to manage chronic diseases and for traditionally underserved communities and people of color. A laboratory stewardship program, focused on peri-pandemic care, positions pathologists and other laboratory professionals as health care leaders with a commitment to appropriate, equitable, and efficient care.

Background: This study evaluated the consequences in Europe of the COVID-19 outbreak on pathology laboratories orientated toward the diagnosis of thoracic diseases., Materials and Methods: A survey was sent to 71 pathology laboratories from 21 European countries. The questionnaire requested information concerning the organization of biosafety, the clinical and molecular pathology, the biobanking, the workload, the associated research into COVID-19, and the organization of education and training during the COVID-19 crisis, from 15 March to 31 May 2020, compared with the same period in 2019., Results: Questionnaires were returned from 53/71 (75%) laboratories from 18 European countries. The biosafety procedures were heterogeneous. The workload in clinical and molecular pathology decreased dramatically by 31% (range, 3%-55%) and 26% (range, 7%-62%), respectively. According to the professional category, between 28% and 41% of the staff members were not present in the laboratories but did teleworking. A total of 70% of the laboratories developed virtual meetings for the training of residents and junior pathologists. During the period of study, none of the staff members with confirmed COVID-19 became infected as a result of handling samples., Conclusions: The COVID-19 pandemic has had a strong impact on most of the European pathology laboratories included in this study. Urgent implementation of several changes to the organization of most of these laboratories, notably to better harmonize biosafety procedures, was noted at the onset of the pandemic and maintained in the event of a new wave of infection occurring in Europe., Competing Interests: Disclosure The authors have declared no conflicts of interest. Data sharing Anonymized participant-level data are available for investigators. Ethical approval The study complied with the law of January 1978 (78-17) relating to computing, data, and freedom known as ‘computing and freedoms’ and with rules 2016/679 of the European Parliament (of 25 May 2018) concerning the general data protection regulation (GDPR; MR004). The study was registered by the Nice University Hospital (R04-39) and filed on the Health Data Hub website (7 July 2020) (www.health-data-hub.fr/depot)., (Copyright © 2020 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: Globally, few studies have examined the effect of the COVID-19 pandemic on routine patient care and follow-up., Objectives: To evaluate the effect of the COVID-19 response on biochemical test requests received from outpatient departments (OPDs) and peripheral clinics serviced by the National Health Laboratory Service Chemical Pathology Laboratory at Tygerberg Hospital, Cape Town, South Africa (SA). Request volumes were used as a measure of the routine care of patients, as clinical information was not readily available., Methods: A retrospective audit was conducted. The numbers of requests received from OPDs and peripheral clinics for creatinine, glycated haemoglobin (HbA1c), lipid profiles, thyroid-stimulating hormone (TSH), free thyroxine, free tri-iodothyronine (fT3), serum and urine protein electrophoresis, serum free light chains and neonatal total serum bilirubin were obtained from 1 March to 30 June for 2017, 2018, 2019 and 2020., Results: The biggest impact was seen on lipids, creatinine, HbA1c, TSH and fT3. The percentage reduction between 1 March and 30 June 2019 and between 1 March and 30 June 2020 was 59% for lipids, 64% for creatinine and HbA1c, 80% for TSH and 81% for fT3. There was a noteworthy decrease in overall analyte testing from March to April 2020, coinciding with initiation of level 5 lockdown. Although an increase in testing was observed during June 2020, the number of requests was still lower than in June 2019., Conclusions: This study, focusing on the short-term consequences of the SA response to the COVID-19 pandemic, found that routine follow-up of patients with communicable and non-communicable diseases was affected. Future studies are necessary to evaluate the long-term consequences of the pandemic for these patient groups.

We present preliminary results of a coronavirus disease (COVID-19) impact assessment on testing for HIV, viral hepatitis and sexually transmitted infections in the WHO European Region. We analyse 98 responses from secondary care (n = 36), community testing sites (n = 52) and national level (n = 10). Compared to pre-COVID-19, 95% of respondents report decreased testing volumes during March-May and 58% during June-August 2020. Reasons for decreases and mitigation measures were analysed.

With the recent developments in information technology, real world big data studies (RWBDSs) have attracted increasing attention in the field of medicine. In RWBDSs, clinical laboratory data is an important part of the wider scope of real-world medical data, and its standardized use is critical for the generation of high-quality real-world evidence. To improve the core functioning and competitiveness of clinical laboratories as well as provide high-quality medical services for patients, it is important to construct an information analysis model and perform RWBDSs. However, among the majority of developing countries, as well as in some developed countries, due to the poorly developed neglect of data formatting standards information construction and the lack of consideration for, and experience with, the ideas and methods of RWBDSs, many clinical laboratories are unable to make use of the vast amount of data stored in their systems. Additionally, in the literature, there remain many areas that require improvements, such as the correct misuse of research methods, appropriate unreasonable data presentation methods, and optimal opaque methods for data cleaning, storage, and mining. In this review, we describe both the advantages and disadvantages of RWBDSs in laboratory medicine. In addition, we summarize the current application and methods of RWBDS in laboratory medicine from seven different perspectives: the establishment of a reference interval, patient data-based real time quality control, diagnostic or prognostic modeling, epidemiological investigation, laboratory management, analysis of sources of variations for analytes, and external quality assessment. Finally, we discuss the future prospects of this research. This review can provide the basis for clinical laboratories to carry out real world research; additionally, it promotes and standardizes RWBDS in laboratory medicine., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2020 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.)

Objective: To describe the perspective of grossing technology and highlight the prospective of its development in histology laboratory., Methods: Analysis of different components of grossing technology., Results: Increased requirements for a specimen's turnaround time and the advancements in modern processing equipment make the triage of workflow a significant part of a grossing person's responsibilities. The implementation of digital pathology in morphology studies practice requires standardization of fixation, the thickness of gross section, and optimal embedding orientation. To meet tomorrow's challenges, grossing technology should work on embedding automation and gross digital pathology to record gross sections corresponding the microscope slide. Specialization of grossing stations might be beneficial to the quality of processing and smooth workflow productivity. The emerging grossing technologist subspecialty requires development of a special training program., Conclusion: Grossing technology can contribute to new challenges in modern histology laboratory, assuring high-quality microscope slides for the pathologist's diagnosis and research evaluation., (© American Society for Clinical Pathology 2019. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

The global coronavirus disease 2019 (COVID-19) has presented major challenges for clinical laboratories, from initial diagnosis to patient monitoring and treatment. Initial response to this pandemic involved the development, production, and distribution of diagnostic molecular assays at an unprecedented rate, leading to minimal validation requirements and concerns regarding their diagnostic accuracy in clinical settings. In addition to molecular testing, serological assays to detect antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are now becoming available from numerous diagnostic manufacturers. In both cases, the lack of peer-reviewed data and regulatory oversight, combined with general misconceptions regarding their appropriate use, have highlighted the importance of laboratory professionals in robustly validating and evaluating these assays for appropriate clinical use. The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Task Force on COVID-19 has been established to synthesize up-to-date information on the epidemiology, pathogenesis, and laboratory diagnosis and monitoring of COVID-19, as well as to develop practical recommendations on the use of molecular, serological, and biochemical tests in disease diagnosis and management. This review summarizes the latest evidence and status of molecular, serological, and biochemical testing in COVID-19 and highlights some key considerations for clinical laboratories operating to support the global fight against this ongoing pandemic. Confidently this consolidated information provides a useful resource to laboratories and a reminder of the laboratory's critical role as the world battles this unprecedented crisis.

Background: About forty-five years ago the advent of Sanger sequencing (Sanger and Coulson 1975) was revolutionary as it allowed deciphering of complete genome sequences. A second revolution came when next-generation sequencing (NGS) technologies accelerated and cheapened genome sequencing. Recently, third generation/longread sequencing methods have appeared, which can directly detect epigenetic modifications on native DNA and allow whole-transcript sequencing without the need for assembly. Nanopore sequencing is one of these third-generation approaches, enabling a single molecule of DNA or RNA to be sequenced in real-time without the need for PCR amplification or chemical labelling of the sample. It works by monitoring changes to an electrical current as nucleic acids are passed through protein or synthetic nanopores., Methods: A literature search was performed in order to collect and summarize current information about the methodological aspects of nanopore sequencing as well as some application examples., Results: The review describes concisely and comprehensibly the technical aspects of nanopore sequencing and stresses the advantages and disadvantages of this technique thereby also giving examples of their potential applications in the clinical routine laboratory as are rapid identification of viral pathogens, monitoring Ebola, environmental and food safety monitoring, human and plant genome sequencing, monitoring of antibiotic resistance, and other applications., Conclusions: It is a useful incitation for such ones being permanently in search of upgrading their laboratory.

The coronavirus disease 2019 (COVID-19) is a pandemic caused by the SARS-CoV-2 virus. The infection has predominantly respiratory transmission and is transmitted through large droplets or aerosols, and less commonly by contact with infected surfaces or fomites. The alarming spread of the infection and the severe clinical disease that it may cause have led to the widespread institution of social distancing measures. Because of repeated exposure to potentially infectious patients and specimens, health care and laboratory personnel are particularly susceptible to contract COVID-19. This review paper provides an assessment of the current state of knowledge about the disease and its pathology, and the potential presence of the virus in cytology specimens. It also discusses the measures that cytology laboratories can take to function during the pandemic, and minimize the risk to their personnel, trainees, and pathologists. In addition, it explores potential means to continue to educate trainees during the COVID-19 pandemic., (Copyright © 2020 American Society of Cytopathology. Published by Elsevier Inc. All rights reserved.)

Background: The results of laboratory tests play a critical role in patient management, so the clinical laboratory is obligated to report accurate results. However, the pre-analytical phase, in which human factors are mainly involved, is clearly a vulnerable part of the laboratory process. This study was conducted to investigate and analyze pre-analytical errors. The author intended to reduce these errors by some measures in order to enhance the credibility of the laboratory., Methods: A retrospective study was conducted to identify the rates and the types and frequencies of pre-analytical errors in the laboratory and analyze them according to the departments of patients, the sections of the laboratory, and the wards of the hospital. The reasons for these errors were persistently identified and analyzed in order to make efforts to reduce the errors. The activities for quality improvement including education and training programs on the phlebotomy teams were also accomplished to reduce these errors., Results: The overall rate of pre-analytical errors was 0.40%. The rate of these errors significantly decreased from 0.44% in 2017 to 0.36% in 2018. In particular, the proportion of improper volume decreased from 46.1% in 2017 to 36.4% in 2018. The most common pre-analytical error was 'improper volume' (41.5%), followed by 'undue clotting' (32.8%). These errors were overwhelmingly more common in inpatients than in outpatients. The rate of these errors was the highest in stat section (1.95%)., Conclusions: Clinical laboratory should make efforts to reduce pre-analytical errors in order to report accurate and expeditious results. Reduction of these errors can be achieved through analyzing and correcting the reasons for them and education and training on the phlebotomy teams and, as a result, the credibility of the laboratory may also be enhanced.

Internal and external factors influence the future of laboratory medicine. In the coming years point of care testing and faster and cheaper methods of genome sequencing are predicted to become more important. Changes in laboratory organization and demography with an aging population will likewise impact the coming years. An increased information flow between laboratories and clinicians, where symptoms, findings and vital signs are combined with laboratory results and their change over time, has the potential of generating refined reports. Sharing of equipment between laboratory specialities as well as working in conjunction with clinicians in influencing patterns of testing through guidelines and algorithms may also aid in saving precious resources.

Background: For far too long, the diagnosis of bloodstream infections has relied on time-consuming blood cultures coupled with traditional organism identification and susceptibility testing. Technologies to define the culprit in bloodstream infections have gained sophistication in recent years, notably by application of molecular methods., Content: In this review, we summarize the tests available to clinical laboratories for molecular rapid identification and resistance marker detection in blood culture bottles that have flagged positive. We explore the cost-benefit ratio of such assays, covering aspects that include performance characteristics, effect on patient care, and relevance to antibiotic stewardship initiatives., Summary: Rapid blood culture diagnostics represent an advance in the care of patients with bloodstream infections, particularly those infected with resistant organisms. These diagnostics are relatively easy to implement and appear to have a positive cost-benefit balance, particularly when fully incorporated into a hospital's antimicrobial stewardship program., (© 2018 American Association for Clinical Chemistry.)

Background: Clinical laboratory reference intervals are derived from a sample of selected healthy population and they are used for disease diagnosis, management, and monitoring. International guidelines recommended that laboratories and manufacturers are supposed to establish their own RIs for a certain group of population. Therefore, the aim of this narrative review is to summarize the current status and to show future directions regarding reference intervals of clinical laboratory parameters among Ethiopian population. Methods: PubMed, Google Scholar, and Google databases were searched to access relevant reference interval studies in Ethiopia. Journal articles, guidelines, reports, and related documents published in English language were included without publication period restriction. Results: Fifteen studies were conducted to establish local reference intervals for hematology, immunology, and clinical chemistry parameters in Ethiopia from 1999 - 2018. The majority of those studies determined clinical laboratory reference intervals for adults only. Some other Ethiopian reference interval studies did not include the majority of routine hematology and clinical chemistry parameters. In addition, the studies we reviewed did not consider the cultural, ethnic, demographic, and geographical diversity of Ethiopian population. Conclusions: There is limited data regarding locally established reliable clinical laboratory reference intervals in Ethiopia though attempts are made. Therefore, further local reference interval studies should be undertaken considering the cultural, ethnic, demographical, and geographical diversity of the Ethiopian population.

In the last few decades, laboratory medicine has undergone monumental changes, and laboratory technology, which has made enormous advances, now has new clinical applications thanks to the identification of a growing number of biomarkers and risk factors conducive to the promotion of predictive and preventive interventions that have enhanced the role of laboratory medicine in health care delivering. However, the paradigm shift in the past 50 years has led to a gap between laboratory and clinic, with an increased risk of inappropriateness in test request and interpretation, as well as the consolidation of analytical work in focused factories and megastructurers oriented only toward achieving greater volumes, decreasing cost per test and generating a vision of laboratory services as simple commodities. A careful historical revision of the changing models for delivering laboratory services in the United States leads to the prediction that there are several reasons for counteracting the vision of clinical laboratory as a commodity, and restoring the true nature of laboratory services as an integral part of the diagnosis and therapy process. The present study, which reports on internal and external drivers for change, proposes an integrated vision of quality in laboratory medicine.

Context: Health care professionals must continually identify collaborative ways to combat antibiotic resistance while improving community health and health care delivery. Clinical Laboratory Improvement Amendments of 1988 (CLIA)-waived point-of-care (POC) testing (POCT) services for infectious disease conducted in community pharmacies provide a means for pharmacists to collaborate with prescribers and/or public health officials combating antibiotic resistance while improving community health and health care delivery., Objective: To provide a comprehensive literature review that explores the potential for pharmacists to collaborate with public health professionals and prescribers using pharmacy-based CLIA-waived POCT services for infectious diseases., Design: Comprehensive literature review., Setting: PubMed and Google Scholar were searched for manuscripts and meeting abstracts for the following key words: infectious disease, community pharmacy, rapid diagnostic tests, rapid assay, and POC tests., Intervention: All relevant manuscripts and meeting abstracts utilizing POCT in community pharmacies for infectious disease were reviewed., Outcome Measure: Information regarding the most contemporary evidence regarding CLIA-waived POC infectious diseases tests for infectious diseases and their use in community pharmacies was synthesized to highlight and identify opportunities to develop future collaborations using community pharmacy-based models for such services., Results: Evidence demonstrates that pharmacists in collaboration with other health care professionals can leverage their knowledge and accessibility to provide CLIA-waived POCT services for infectious diseases. Testing for influenza may augment health departments' surveillance efforts, help promote rationale antiviral use, and avoid unnecessary antimicrobial therapy. Services for human immunodeficiency virus infection raise infection status awareness, increase access to health care, and facilitate linkage to appropriate care. Testing for group A streptococcal pharyngitis may curb inappropriate outpatient antibiotic prescribing. However, variance in pharmacy practice statues and the application of CLIA across states stifle collaboration., Conclusion: CLIA-waived POCT services for infectious diseases are a means for pharmacists, public health professionals, and prescribers to collaboratively combat antibiotic resistance and improve community health.

Background: Assessment of endogenous insulin secretion by measuring C-peptide concentrations is widely accepted. Recent studies have shown that preservation of even small amounts of endogenous C-peptide production in patients with type 1 diabetes reduces risks for diabetic complications. Harmonization of C-peptide results will facilitate comparison of data from different research studies and later among clinical laboratory results at different sites using different assay methods., Content: This review provides an overview of the general process of harmonization and standardization and the challenges encountered with implementing a reference measurement system for C-peptide., Summary: Efforts to harmonize C-peptide results are described, including those by the National Institute of Diabetes and Digestive and Kidney Diseases-led C-peptide Standardization Committee in the US, activities in Japan, efforts by the National Institute for Biological Standards and Control in the UK, as well as activities led by the Bureau International des Poids et Mesures and the National Metrology Institute in China. A traceability scheme is proposed along with the next steps for implementation. Suggestions are made for better collaboration to optimize the harmonization process for other measurands., (© 2017 American Association for Clinical Chemistry.)

Medical biology is a major area of medical specialization in French health care system. It is going through massive changes in public as in private sector since the 2010 Ballereau edict with the merging of laboratories and new quality standards based on accreditation. We have suggested that physicians had a negative feeling about the restructuring of medical biology in recent years. An electronic questionnaire has been sent to physicians so as to find out what they thought about the evolution of medical biology and to get suggestions to improve the taking care of the patient. Have answered 1364 residents and physicians from all specializations, all regions, practicing in public or private hospitals or in general practices. Doctors have on the whole a negative feeling about how medical biology has evolved in recent years thinking that it is moving towards industrialization with delay increasing. They are convinced that tests must be made on site. They remain satisfied with the quality of the tests and have a positive feeling about scientific evolutions and are in favor of a better clinical-biological cooperation. The study points out a lack of clarity concerning how private laboratories are organized and how they operate. A computer link between clinical pathologists and physicians to access results and a list of urgent medical examinations could be set up so as to have a more rapid access to results. Rapid diagnostic tests or delocalized biology could be used but doctors do not want these tests to replace the clinical pathologist.

The performance of matrix-assisted laser desorption ionization time-of-flight mass spectrometry (MS) for routine bacterial and yeast identification as well as direct-from-blood culture bottle identification has been thoroughly evaluated in the peer-reviewed literature. Microbiologists are now moving beyond these methods to apply MS to other areas of the diagnostic process. This review discusses the emergence of advanced matrix-assisted laser desorption ionization time-of-flight MS applications, including the identification of filamentous fungi and mycobacteria and the current and future state of antimicrobial resistance testing., (Copyright © 2016 American Society for Investigative Pathology and the Association for Molecular Pathology. Published by Elsevier Inc. All rights reserved.)

Context: -Next-generation sequencing (NGS) is revolutionizing the discipline of laboratory medicine, with a deep and direct impact on patient care. Although it empowers clinical laboratories with unprecedented genomic sequencing capability, NGS has brought along obvious and obtrusive informatics challenges. Bioinformatics and clinical informatics are separate disciplines with typically a small degree of overlap, but they have been brought together by the enthusiastic adoption of NGS in clinical laboratories. The result has been a collaborative environment for the development of novel informatics solutions. Sustaining NGS-based testing in a regulated clinical environment requires institutional support to build and maintain a practical, robust, scalable, secure, and cost-effective informatics infrastructure., Objective: -To discuss the novel NGS informatics challenges facing pathology laboratories today and offer solutions and future developments to address these obstacles., Data Sources: -The published literature pertaining to NGS informatics was reviewed. The coauthors, experts in the fields of molecular pathology, precision medicine, and pathology informatics, also contributed their experiences., Conclusions: -The boundary between bioinformatics and clinical informatics has significantly blurred with the introduction of NGS into clinical molecular laboratories. Next-generation sequencing technology and the data derived from these tests, if managed well in the clinical laboratory, will redefine the practice of medicine. In order to sustain this progress, adoption of smart computing technology will be essential. Computational pathologists will be expected to play a major role in rendering diagnostic and theranostic services by leveraging "Big Data" and modern computing tools.

Context: -Prior to 1900, laboratory tests were simple enough to be performed by clinicians on the wards and most pathologists were academicians with little involvement in patient care issues. In the next 2 decades, laboratory test menus expanded rapidly and the increasing complexity of the tests created a potential niche for clinical pathologists (ie, pathologists providing patient-oriented anatomic and clinical pathology services). In the late 1910s and early 1920s, most of these services were provided by mail-order commercial laboratories or state public health laboratories rather than by hospital-based pathologists., Objective: -To describe the political events in the 1920s that would drastically alter the practice of pathology and laboratory medicine and that would have been important to the discipline at the time the Archives of Pathology and Laboratory Medicine was being conceived and first published., Design: -Available primary and secondary historical sources were reviewed., Results: -In the 1920s, clinical pathologists organized, forming the American Society of Clinical Pathologists, and took on the powerful American Medical Association for permitting advertisements by private laboratories in the pages of the Journal of the American Medical Association that listed test prices as if these were commodities. They found a strong partner in the American College of Surgeons, which was attempting to elevate surgical practice by creating minimum standards for hospitals. Through this symbiotic relationship, hospital-based practice was firmly established and the commercial laboratory model faltered., Conclusions: -The Roaring Twenties was the time when the practice of pathology and laboratory medicine evolved into what we recognize today.

"Accreditation Activities for Medical Laboratories in Japan" Audits for transition to ISO 15189:2012 continue to progress. Besides the continual increase of accreditations for medical laboratory testing and pathological examinations, preparations for the addition of physiological testing to the scope of accreditation have finally been completed. As a part of the revision to Japan's Medical Service Act, the external evaluation of medical laboratories is now a requirement to approve clinical trial core hospitals. Accordingly, the importance of third-party accreditation in medical laboratory testing is attracting a growing level of attention. World Accreditation Day 2015 "Accreditation: Supporting the Delivery of Health and Social Care" JAB is being used to make every effort to contribute to this system in order to improve the quality of healthcare in Japan and the health of its citizens.

A clinical laboratory test is an auxiliary way to facilitate an accurate diagnosis and medical care; therefore, the essence of such clinical tests would not change at all even if laboratory technology and systems are improved. On the top of that, clinical tests have an important responsibility in medical treatment. Especially, a clinical test in emergency medicine or a life-threatening situation is more important to save lives. The responsibility and importance of clinical laboratory tests in patient care are increasing due to the high capability for not only diagnosis but also making critical medical decisions and judging the level of seriousness, emergency, and efficacy of the medical treatment prescribed. Recently, medical treatment became advanced and complicated, meaning that emergency laboratory tests should be prioritized based on the seriousness and critical condition of patients. We, medical technologists, need to work more aggressively and understand the situation. In this report, I would like to share an opportunity with you to comprehend where we are today with rapid improvements in emergency medicine and the latest systems, and to reconsider how we (medical technologists) are responsible for contributing to better patient care. [Review].

Following the accreditation of this hospital as an Emergency and Critical Care Center and the subsequent establishment of an emergency intensive care unit in April 2013, walk-in patients of the Emergency Department now total over 60,000 annually, with 10,000 arriving by ambulance. Out-of-hours medical laboratory services in this hospital commenced in 1972, providing services including blood analysis and blood product provision. Since the establishment of the Emergency and Critical Care Center, an increase in the number of severe cases has also led to an increase in blood transfusions, requiring a specialized response from the Medical Laboratory. We describe measures taken by the Medical Laboratory to continue ongoing laboratory support of the Emergency Department. [Review].

In Japan, the primary 'baby-boomer' generation, born between 1947 and 1949, is now in its retirement. This has caused a marked shortage of human resources nationwide. Clinical laboratory technologists are no exception, and many clinical laboratories in Japanese healthcare facilities are struggling with management because the number of new graduates, i.e., newly licensed technologists, is mostly fixed and, therefore, their recruitment is becoming more and more competitive. Our laboratory is now facing a wave of mass-retirement associated with our history. In addition, in the early 2000s, there was almost no position for new graduates replacing those retiring because of the change in the social healthcare system as well as our hospital's policy. This resulted in uneven numbers of technologists in generations, and it seemed to be getting worse. Fortunately, five years ago, the direction of social health care was changed and lots of positions became available as a result. We have been trying to recruit new graduates and experienced technologists as well, and were able to hire 18 people. Among them, 8 were non-freshmen. The generation gap has been mostly resolved. We will continue to make our laboratory more attractive not just to new graduates but also to experienced technologists, especially those who wish to return to work after a several-year absence to raise their children. We believe that this will energize our laboratory.

The management of clinical laboratories in hospitals has to be changed in accordance with the trends in the healthcare-providing system. In this symposium, six presenters talked about various issues associated with their laboratories. The issues raised included conflict between specialty and generality, phlebotomy as a duty of laboratory technologists, management of the phlebotomy section, imbalance of numbers between retirees and newcomers, and cooperation with the division of clinical research. Presenters, chairmen, and the audience were able to understand that we are now facing these issues, and we could identify some of their solutions.

In anatomic pathology, the current state encompassing the pre-analytic processes of tissue collection, handling, examination, preparation, processing, and storage are largely uncontrolled, inconsistently performed, and/or not standardized according to the sound scientific data. Pre-analytic defects result in nearly three-quarters of the problems in laboratory diagnostics. This is evident in quality surveys from well-respected institutions that document high miss rates in the required basics of information related to patient and tissue identity, let alone parameters documenting quality aspects related to the surgical specimen and its preservation. This talk will describe the historical approach to tissue processing and identify gaps from worldwide observations in current laboratory practices. It will also offer potential methodological and technological solutions and process improvements that laboratories may consider in serving the ultimate users of pathology information: the clinician and the patient. It illustrates the need for scientifically validated specimen guidelines and a performance based, standardized and documented "chain of custody" of the pre-analytical steps from the patient's body through fixation. For thought leaders and professional standard setters, opportunities for optimizing molecular studies exist in specimen collection, transfer, grossing, fixation, and decalcification protocols. In this evolving era of molecular profiling and personalized therapeutic decision-making, a well-reasoned and coordinated focus on pre-analytic processes that optimizes specimens for subsequent testing will result in: Improved specimen quality for molecular testing Improved accuracy of diagnostic and molecular test results Reduced Turnaroundtimes for same-day diagnosis Enhanced satisfaction of clinicians and patients.

Recently, medical team approaches were pointed out to be important in the field of laboratory medicine. The staff working in laboratory medicine needs to participate in various kinds of medical team such as ICT or NST. With such a background, the working group for medical teams was established in the Japanese Society of Laboratory Medicine in January 2012. Special program II was organized by this group at the 60th annual meeting held in Kobe in 2013. People gathered from representative societies related to laboratory medicine and discussed how we should participate in team approaches. Based on the results of meaningful discussions, we have reached a strong consensus to pursue team approaches in the future.

Background: Ireland had the highest incidence of prostate cancer in Europe in 2008, due to widespread prostate specific antigen (PSA) testing., Aims: To investigate practices and costs of PSA testing in Ireland, 2008-2010., Methods: Postal laboratory questionnaire. Results were compared with 2006 and 2007 surveys., Results: Response rate was 95 % (42/44). In 2010, 37 laboratories measured total PSA (tPSA); 10 measured free PSA (fPSA). Eight assays were used and cut-offs to define 'normal' tPSA varied widely. There was a 9.9 % annual increase in the number of tPSA tests and a -31 % annual decrease in the number of fPSA, 2006-2010. A 100-fold difference in tPSA workload was observed across laboratories. In 2010, the estimated cost of PSA testing was 3,649,984 (95 % CI 2,532,745-4,767,222)., Conclusions: Health service costs of PSA testing are significant. The number of tPSA tests continues to rise; fPSA use fell by almost one-third. Inter-laboratory variation in testing practices persists. These have potentially important clinical consequences for men and need to be addressed.

Context: Changes in reimbursements for clinical laboratory testing may help us assess the effect of various variables, such as testing recommendations, market forces, changes in testing technology, and changes in clinical or laboratory practices, and provide information that can influence health care and public health policy decisions. To date, however, there has been no report, to our knowledge, of longitudinal trends in national laboratory test use., Objective: To evaluate Medicare Part B-reimbursed volumes of selected laboratory tests per 10,000 enrollees from 2000 through 2010., Design: Laboratory test reimbursement volumes per 10,000 enrollees in Medicare Part B were obtained from the Centers for Medicare & Medicaid Services (Baltimore, Maryland). The ratio of the most recent (2010) reimbursed test volume per 10,000 Medicare enrollees, divided by the oldest data (usually 2000) during this decade, called the volume ratio, was used to measure trends in test reimbursement. Laboratory tests with a reimbursement claim frequency of at least 10 per 10,000 Medicare enrollees in 2010 were selected, provided there was more than a 50% change in test reimbursement volume during the 2000-2010 decade. We combined the reimbursed test volumes for the few tests that were listed under more than one code in the Current Procedural Terminology (American Medical Association, Chicago, Illinois). A 2-sided Poisson regression, adjusted for potential overdispersion, was used to determine P values for the trend; trends were considered significant at P < .05., Results: Tests with the greatest decrease in reimbursement volumes were electrolytes, digoxin, carbamazepine, phenytoin, and lithium, with volume ratios ranging from 0.27 to 0.64 (P < .001). Tests with the greatest increase in reimbursement volumes were meprobamate, opiates, methadone, phencyclidine, amphetamines, cocaine, and vitamin D, with volume ratios ranging from 83 to 1510 (P < .001)., Conclusions: Although reimbursement volumes increased for most of the selected tests, other tests exhibited statistically significant downward trends in annual reimbursement volumes. The observed changes in reimbursement volumes may be explained by disease prevalence and severity, patterns of drug use, clinical or laboratory practices, and testing recommendations and guidelines, among others. These data may be useful to policy makers, health systems researchers, laboratory directors, and industry scientists to understand, address, and anticipate trends in laboratory testing in the Medicare population.

Background: Preoperative laboratory testing is commonplace in the clinical setting and is often utilized at surgeon discretion. We searched the American College of Surgeons-National Surgical Quality Improvement Program (ACS-NSQIP) data set to determine the impact of preoperative laboratory testing in ambulatory plastic surgery patients., Objective: The authors assess the utilization and predictive value of preoperative laboratory testing in outpatient plastic surgery procedures., Methods: Patients undergoing ambulatory plastic surgery were identified from the 2005 to 2010 NSQIP databases. Laboratory tests were categorized by group: hematologic, chemistry, coagulation, and liver function tests (LFT). We defined complications in 2 groups: major postoperative and wound complications. Multivariate analyses were used to identify patient characteristics associated with testing and to assess the ability of laboratory testing to predict postoperative complications., Results: A total of 5359 (62.0%) patients underwent testing; 881 (16.4%) tests were performed on the day of surgery. In patients with no defined NSQIP comorbidities, 59.4% underwent preoperative testing and had a significantly lower rate of abnormal findings (33.4% vs 25.3%, P < .0001). In multivariate analyses, testing was associated with older age, American Society of Anesthesiologists class >2, Hispanic or African American race, body contouring procedures, epidural or spinal procedures, and with diabetes, hypertension, and cancer. Major complications occurred in 0.34% of patients. Our analysis demonstrated that neither testing nor abnormal results were associated with postoperative complications, either major (P = .178) or wound (P = .150)., Conclusions: We found no association between abnormal laboratory testing and postoperative morbidity. Preoperative testing in low-risk ambulatory plastic surgery patients may be costly and has limited direct clinical benefit.