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Background: Patient surges beyond hospital capacity during the initial phase of the COVID-19 pandemic emphasized a need for clinical laboratories to prepare test processes to support future patient care. The objective of this study was to determine if current instrumentation in local hospital laboratories can accommodate the anticipated workload from COVID-19 infected patients in hospitals and a proposed field hospital in addition to testing for non-infected patients., Methods: Simulation models predicted instrument throughput and turn-around-time for chemistry, ion-selective-electrode, and immunoassay tests using vendor-developed software with different workload scenarios. The expanded workload included tests from anticipated COVID patients in 2 local hospitals and a proposed field hospital with a COVID-specific test menu in addition to the pre-pandemic workload., Results: Instrumentation throughput and turn-around time at each site was predicted. With additional COVID-patient beds in each hospital, the maximum throughput was approached with no impact on turnaround time. Addition of the field hospital workload led to significantly increased test turnaround times at each site., Conclusions: Simulation models depicted the analytic capacity and turn-around times for laboratory tests at each site and identified the laboratory best suited for field hospital laboratory support during the pandemic., (© American Association for Clinical Chemistry 2020. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Background: To the authors' knowledge, the impact of the coronavirus disease 2019 (COVID-19) pandemic on cytopathology practices worldwide has not been investigated formally. In the current study, data from 41 respondents from 23 countries were reported., Methods: Data regarding the activity of each cytopathology laboratory during 4 weeks of COVID-19 lockdown were collected and compared with those obtained during the corresponding period in 2019. The overall number and percentage of exfoliative and fine-needle aspiration cytology samples from each anatomic site were recorded. Differences in the malignancy and suspicious rates between the 2 periods were analyzed using a meta-analytical approach., Results: Overall, the sample volume was lower compared with 2019 (104,319 samples vs 190,225 samples), with an average volume reduction of 45.3% (range, 0.1%-98.0%). The percentage of samples from the cervicovaginal tract, thyroid, and anorectal region was significantly reduced (P < .05). Conversely, the percentage of samples from the urinary tract, serous cavities, breast, lymph nodes, respiratory tract, salivary glands, central nervous system, gastrointestinal tract, pancreas, liver, and biliary tract increased (P < .05). An overall increase of 5.56% (95% CI, 3.77%-7.35%) in the malignancy rate in nongynecological samples during the COVID-19 pandemic was observed. When the suspicious category was included, the overall increase was 6.95% (95% CI, 4.63%-9.27%)., Conclusions: The COVID-19 pandemic resulted in a drastic reduction in the total number of cytology specimens regardless of anatomic site or specimen type. The rate of malignancy increased, reflecting the prioritization of patients with cancer who were considered to be at high risk. Prospective monitoring of the effect of delays in access to health services during the lockdown period is warranted., (© 2020 American Cancer Society.)

Background: Coronavirus disease 2019 is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and represents the causative agent of a potentially fatal disease. The spread of the infection and the severe clinical disease have led to the widespread adoption of social distancing measures. Special attention and efforts to protect or reduce transmission have been applied at all social levels, including health care operators. Hence, this reports focuses on the description of a new protocol for the safe management of cytological samples processed by liquid-based cytology (LBC) with an evaluation of the changes in terms of morphology and immunoreactivity., Methods: From March 11 to April 25, 2020, 414 cytological cases suspicious for SARS-CoV-2 were processed with a new virus-inactivating method suggested by Hologic, Inc, for all LBC specimens., Results: The samples showed an increased amount of fibrin in the background. A slight decrease in cellular size was also observed in comparison with the standard method of preparation. Nonetheless, the nuclear details of the neoplastic cells were well identified, and the immunoreactivity of the majority of those cells was maintained. The cell blocks did not show significant differences in morphology, immunoreactivity, or nucleic acid stability., Conclusions: Despite some minor changes in the morphology of the cells, the results of this study highlight that the adoption of the new protocol for the biosafety of LBC-processed samples in pathology laboratories is important for minimizing the risk for personnel, trainees, and cytopathologists without impairing the diagnostic efficacy of the technique., (© 2020 American Cancer Society.)

Bacteriology remained essentially manual for many years. After a partial automation for blood cultures, identifications and sensitivity testing, new technological developments including robotisation and digital pictures made it possible to open new ways. In the context of economic pression and need to increase the quality, automation offers multiple advantages concerning increase of productivity, standardization, traceability and decreasing of the delay to obtain the results. Moreover the use of digitalized pictures opens the way to tele-bacteriology, particularly useful when considering the merging of hospital laboratories because it makes it possible to geographically dissociate strict manipulation from the validation of the results and from the consultant activity of the microbiologist. The choice criteria of the equipment are detailed as well as the experience of the LHUB-ULB bacteriological laboratory which was automated at the time of merging of the Brussels public hospital laboratories and developed a conclusive experience of tele-bacteriology for the peripheral lab.

Diagnosis and management of uveitis always remains a challenge to the treating ophthalmologists. Rapid diagnosis and timely initiation of appropriate, effective treatment in uveitis are the critical determinants that lead to good visual outcome and reduce the risk of ocular morbidity. In the last decade, significant progress has been made in molecular diagnostic modalities and in development of newer diagnostic tools, which included serological tests and imaging techniques. However, a tailored approach to laboratory investigations based on meticulous history and comprehensive ocular evaluation has been propounded as the gold standard for successful management of an uveitic entity. In this article, we review the laboratory diagnostic tests in uveitis as well as recent technological advances in laboratory science, which may be the future direction for diagnosis of uveitis., (Copyright © 2018 Canadian Ophthalmological Society. Published by Elsevier Inc. All rights reserved.)

During the past decades the healthcare systems have rapidly changed and today hospital care is primarily advocated for critical patients and acute treatments, for which laboratory test results are crucial and need to be always reported in predictably short turnaround time (TAT). Laboratories in the hospital setting can face this challenge by changing their organization from a compartmentalized laboratory department toward a decision making-based laboratory department. This requires the implementation of a core laboratory, that exploits total laboratory automation (TLA) using technological innovation in analytical platforms, track systems and information technology, including middleware, and a number of satellite specialized laboratory sections cooperating with care teams for specific medical conditions. In this laboratory department model, the short TAT for all first-line tests performed by TLA in the core laboratory represents the key paradigm, where no more stat testing is required because all samples are handled in real-time and (auto)validated results dispatched in a time that fulfills clinical needs. To optimally reach this goal, laboratories should be actively involved in managing all the steps covering the total examination process, speeding up also extra-laboratory phases, such sample delivery. Furthermore, to warrant effectiveness and not only efficiency, all the processes, e.g. specimen integrity check, should be managed by middleware through a predefined set of rules defined in light of the clinical governance., (Crown Copyright © 2017. Published by Elsevier Inc. All rights reserved.)

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.

Background: Mycobacterium tuberculosis causes the majority of tuberculosis (TB) cases in humans; however, in developing countries, human TB caused by M. bovis may be frequent but undetected. Human TB caused by M. bovis is considered a zoonosis; transmission is mainly through consumption of unpasteurized dairy products, and it is less frequently attributed to animal-to-human or human-to-human contact. We describe the trends of M. bovis isolation from human samples and first-line drug susceptibility during a 15-year period in a referral laboratory located in a tertiary care hospital in Mexico City., Methodology/principal Findings: Data on mycobacterial isolates from human clinical samples were retrieved from the laboratory's database for the 2000-2014 period. Susceptibility to first-line drugs: rifampin, isoniazid, streptomycin (STR) and ethambutol was determined. We identified 1,165 isolates, 73.7% were M. tuberculosis and 26.2%, M. bovis. Among pulmonary samples, 16.6% were M. bovis. The proportion of M. bovis isolates significantly increased from 7.8% in 2000 to 28.4% in 2014 (X(2)trend, p<0.001). Primary STR resistance was higher among M. bovis compared with M. tuberculosis isolates (10.9% vs.3.4%, p<0.001). Secondary multidrug resistance (MDR) rates were 38.5% and 34.4% for M. bovis and M. tuberculosis, respectively (p = 0.637). A rising trend of primary STR monoresistance was observed for both species (3.4% in 2000-2004 vs. 7.6% in 2010-2014; p = 0.02)., Conclusions/significance: There is a high prevalence and a rising trend of M. bovis isolates in our region. The proportion of pulmonary M. bovis isolates is higher than in previous reports. Additionally, we report high rates of primary anti-tuberculosis resistance and secondary MDR in both M. tuberculosis and M. bovis. This is one of the largest reports on drug susceptibility of M. bovis from human samples and shows a significant proportion of first-line anti-tuberculosis drug resistance.

Aim: The purpose of this study is, first to present a 10-year monitoring of postanalytical turnaround time (TAT) adapted to different clinicians and patient situations, second to evaluate and analyse the indicators results during that period of time, and finally to show a synthetic appropriate indicator to be included in the balanced scorecard management system., Methods: TAT indicator for routine samples was devised as the percentage of certain key tests that were verified before a specific time on the phlebotomy day. A weighted mean synthetic indicator was also designed. They were calculated for inpatients at 15:00 and 12:00 and for primary care patients only at 15:00. The troponin TAT of emergency department patients, calculated as the difference between the troponin verification and registration time, was selected as the stat laboratory TAT indicator., Results: The routine and stat TAT improved along the 10-year study period. The synthetic indicator showed the same trend., Conclusions: The implementation of systematic and continuous monitoring over years, promoted a continuous improvement in TAT which will probably benefit patient outcome and safety.

Objectives: The scope of activities performed by clinical laboratory directors is sometimes unfamiliar to other physicians or hospital administrators. Consequently, hospital leadership may undervalue the role and assume that many director level activities could be delegated to a professional manager. In this study, we sought to define the activities of academic laboratory directors, and to determine which activities require doctorate level medical or scientific expertise., Methods: We performed an audit of laboratory director activities at a large academic medical center by reviewing electronic calendars and other available records from the preceding 12 consecutive months. For episodic activities, the directors estimated the average number of hours devoted over the 1-year period., Results: On average, directors worked 54.9 hours per week and performed at least some service work 47.7 weeks per year. Administrative duties accounted for the greatest proportion of effort (47.1%), followed by clinical activities (33.1%) and academic activities (19.8%). Among administrative duties, those that required doctorate level medical or scientific expertise comprised 60.3% of the total administrative effort, whereas the remaining 39.7% (18.7% of total activity) could be performed by a professional manager.., Conclusions: Although the activities of clinical laboratory directors have been described elsewhere, this is the first study detailing the effort allocated to these various activities in quantitative terms. The study demonstrated that less than 20% of an academic laboratory director's effort involves administrative activities that could potentially be performed by a professional manager lacking doctorate level medical or scientific expertise., (Copyright© by the American Society for Clinical Pathology.)

New sequencing techniques are revolutionizing medical practice as its applications are numerous and considerable. We are living a technological turning point in molecular medicine. Indeed, thanks to these new machines, this technological leap allowed us to analyse the human genome with an elarged or even a total view. Genome analysis has applications in all medical fields from now on. Gene analysis in parallel with personalized therapy help in prolonged survival or even cures in some cancers or other diseases. Genetics is progressively arriving in every field of clinical practice. A new way of thinking clinics is born. This publication describes in its main lines these new applications, their problems and their challenges for geneticists as much as for other practitioners in the medical fields.

Some hospitals have begun offering genome sequencing to help patients assess genetic risks. But with the technology still in its early stages, it's unclear how whole genome sequencing will affect the majority of patients and the care they receive.

Bar code-based tracking solutions, long present in clinical pathology laboratories, have recently made an appearance in anatomic pathology (AP) laboratories. Tracking of AP "assets" (specimens, blocks, slides) can enhance laboratory efficiency, promote patient safety, and improve patient care. Routing of excess clinical material into research laboratories and biorepositories are other avenues that can benefit from tracking of AP assets. Implementing tracking is not as simple as installing software and turning it on. Not all tracking solutions are alike. Careful analysis of laboratory workflow is needed before implementing tracking to assure that this solution will meet the needs of the laboratory. Such analysis will likely uncover practices that may need to be modified before a tracking system can be deployed. Costs that go beyond simply that of purchasing software will be incurred and need to be considered in the budgeting process. Finally, people, not technology, are the key to assuring quality. Tracking will require significant changes in workflow and an overall change in the culture of the laboratory. Preparation, training, buy-in, and accountability of the people involved are crucial to the success of this process. This article reviews the benefits, available technology, underlying principles, and implementation of tracking solutions for the AP and research laboratory.

Clinical laboratories in university hospitals should be operated with a good balance of medical practice, education, research, and management. The role of a clinical laboratory is to promptly provide highly reliable laboratory data to satisfy the needs of clinicians involved in medical practice and health maintenance of patients. Improvement and maintenance of the quality of the laboratory staff and environment are essential to achieve this goal. In order to implement these requirements efficiently, an appropriate quality management system should be introduced and established, and evaluated objectively by a third party (e.g. by obtaining ISO 15189 certification). ISO 15189 is an international standard regarding the quality and competence of clinical laboratories, and specifies a review of the efficient operational system and technical requirements such as competence in implementing practical tests and calibration. This means the results of laboratory tests reported by accredited laboratories withstand any international evaluation, which is very important to assure the future importance of the existence and management of clinical laboratories as well as internationalization of medical practice. "Education" and "research" have important implications in addition to "medical practice" and "management", as the roles that clinical laboratories should play in university hospitals. University hospital laboratories should be operated by keeping these four factors in good balance. Why are "education" and "research" required in addition to "medical practice" services? If individual clinical laboratory technologists can provide an appropriate response to this question, the importance of the existence of clinical laboratories would be reinforced, without being compromised.

Background: It is necessary to achieve a reduction in the number of requests for laboratory tests by improving the appropriateness of testing behaviour. The aim of the study was, first, to compare laboratory requiring patterns for emergency department (ED) patients in clinical laboratories of different institutions in Spain; second, to design an appropriateness pre-pre-analytical quality control report based on appropriateness indicators., Methods: A call for data was posted on a website. We obtained production statistics for the year 2010 from emergency laboratories at 36 hospitals. Two types of appropriateness indicators were calculated: test request per 1000 ED admissions or related test requesting ratios. In order to explore the inter-practice variability in tests requests, the 'index of variability' was calculated. A pre-pre-analytical quality control report was designed, prepared and sent to each participating laboratory. The savings generated, if each Health-care Department would have achieved the appropriate indicator standard, were calculated., Results: The rate of request of the stat tests ranged from 44 to 412 per 1000 ED patient admissions. There was a high and peculiar dispersion of related test requesting ratio results. If every single laboratory would have achieved the appropriate indicator, we would have saved 1,019,230 urea, 302,511 AST and 316,161 CK unnecessary tests., Conclusions: There are large variations of test requesting in the emergency setting. An appropriateness pre-pre-analytical quality control report was useful for comparing requesting patterns. The study shows the need to unify demand. The key to achieve this goal will be interdepartmental cooperation between ED clinicians and laboratory professionals.

Context: Measured plasma or serum creatinine concentration is a primary component of equations used to calculate estimated glomerular filtration rate (eGFR). In recent years, most assay manufacturers have adopted creatinine calibration procedures that are traceable to the National Institute of Standards and Technology's Standard Reference Material 967., Objectives: To examine the current performance of creatinine assays, to compare changes in assay performance since 2003, and to examine the reliability of laboratory eGFR calculations., Design: Serum samples spiked with different concentrations of creatinine were analyzed by participating laboratories in the College of American Pathologists' LN24 survey. Participants' reported values were compared against values measured by liquid chromatography-isotope dilution mass spectrometry. Participants were asked to calculate the eGFR for certain samples, and results were compared with those obtained from the 4-parameter Modification of Diet in Renal Disease equation., Results: Biases among current creatinine methods are in the range of -5% to 10%, compared with -7% to 34% seen in a 2003 study. This degree of bias in eGFR calculations is of clinical significance only for concentrations near the cut points used to stage chronic kidney disease. Approximately 20% of laboratories report eGFR values that exceed ±1 mL/min per 1.73 m(2) from the expected eGFR using the 4-parameter Modification of Diet in Renal Disease equation., Conclusions: Since 2003, there have been improvements in the performance of creatinine assays, which appear to be related to the adoption of standard reference materials for calibration. The effect of the observed method biases in clinical practice now appears minimal. Laboratories should continue to monitor the accuracy of eGFR calculations.

Objective: Although clinical microbiology testing facilitates both public health surveillance of infectious diseases and patient care, research on testing patterns is scant. We surveyed hospital laboratories in Georgia to assess their diagnostic testing practices., Methods: Using e-mail, all directors of hospital laboratories in Georgia were invited to participate. The survey focused on timing and location of diagnostic testing in 2006 for 6 reportable diseases: giardiasis, legionellosis, meningococcal disease, pertussis, Rocky Mountain spotted fever, and West Nile virus disease., Results: Of 141 laboratories, 62 (44%) responded to the survey. Hospitals varied widely in their use of diagnostic testing in 2006, with 95.1% testing for meningococcal disease, but only 66.1% and 63.3% testing for legionellosis and West Nile virus disease, respectively. Most laboratories (91%) performed gram stain/culture to diagnose meningococcal disease in-house and 23% performed ova and parasite panels for giardiasis were conducted in-house. Fewer than 11% of laboratories performed in-house testing for the remaining diseases. Laboratories affiliated with small hospitals (≤100 beds) were more likely to send specimens for outside testing compared with laboratories associated with large hospitals (>250 beds). Median turnaround time for ova and parasite panel testing for giardiasis was significantly shorter for in-house testing (1.0 days) than within-system (2.25 days) or outside laboratory (3.0 days) testing (P = .0003). No laboratories reported in-house testing for meningococcal disease, pertussis, or Rocky Mountain spotted fever using polymerase chain reaction., Conclusion: Many hospitals did not order diagnostic tests for important infectious diseases during 2006, even for relatively common diseases. In addition, hospital laboratories were unlikely to perform diagnostic testing in-house; sending specimens to an outside laboratory may result in substantial delays in receiving results. These unsettling findings have adverse implications for both patient care and public health surveillance; they indicate an immediate need to study nationally the use and timeliness of clinical microbiologic testing.

The main benefit of carrying out microbial examinations in a hospital is that it rapidly yields information on infectious diseases. Microbiology technicians can easily communicate with the physicians and can carry out precise analyses. The disadvantages are the high costs of microbiological examinations, and the need for long training times for microbial laboratory technicians because of the highly technical nature of their duties. In-hospital microbial inspections will lead to: 1)improved rapid diagnostic tests for infectious diseases and evaluation of antibiotic treatment in the early stages of disease; 2) detection of the precise origin of microbes and confirmation of etiological factors; 3) antibiotic susceptibility testing and evaluation of combined effects of antibiotics against multiple drug-resistant bacteria; and 4)genetic analysis and epidemiological statistical analysis for the purpose of infection control in a hospital and surrounding areas.

The recent progress in medicine increases the routine works of the physicians or nurses and decreases the chances to obtain the new information on the laboratory medicine. Although the patients desire to know their test results in detail, it is likely to be difficult to obtain them from the physician in charge. Thereby, the quality of the medical services may be deteriorated. In these situations, needs of the medical team approaches in which the medical technologists (MTs) in the hospital laboratories participate are increasing. In Japan, there are a variety of medical team approaches in which MTs are involved. In our university hospital, MTs play important roles in the infection control team (ICT), in the nutrition support team (NST), in the educational class for the patients with diabetes mellitus, in the clinical research center, in the order-made medicine realizing project, in the infertility center and in the laboratory information room. In April 2010, the new payment system for the team approaches such as ICT or NST was established. In the future, the team approaches other than ICT or NST could be chosen for the subjects for the payment if they are recognized as important. The goal of the team approaches is to realize a patient-oriented medicine. MTs can reconfirm that they are working as one of the medical staffs through these team approaches. It is important to always find out a possibility of new team approaches.

Public awareness, the social situation, and the needs of hospital administrators and others arbitrarily affect the significance and role of clinical laboratories at a given time. To manage clinical laboratories in a way that best uses the knowledge, skills, and judgment of the group that specializes in laboratory tests, a future perspective and essential philosophy to make use of their special characteristics seems essential. That philosophy is to contribute to high quality medical care through laboratory test performance, extend the healthy lifespan of people in the community and the nation, support re-integration of patients into society, and contribute to the well-being of society. To realize this philosophy it is essential to demonstrate the importance of the existence of clinical laboratory technicians and physicians. Without this, it may be impossible to discuss what clinical laboratories should be and adopt a future perspective for them. We herein discuss the ideal and current realities of the clinical laboratory as a medical care support department in the Hirosaki University School of Medicine Hospital, and we report issues and problems related to overcoming the gap between the two realities.

Objectives: To describe current qualitative and quantitative aspects of research engagement and other scholarly activities conducted by clinical laboratory science (CLS) professionals across a range of employment settings., Design: A link to a 3-part online survey was sent by electronic mail to 7,572 members of the American Society for Clinical Laboratory Science and 500 program directors., Setting: email message, on-line survey, Participants: all ASCLS members and all directors of accredited clinical laboratory educational programs, Main Outcome Measures: Quantitative and qualitative measures of professionals' engagement in research and other scholarly activities, Results: 556 of 7572 (7.3%) persons completed the survey. Thirty-two percent of survey respondents reported spending between 1 to > 40 work hours per week conducting research with 68% of respondents not participating in research activities. Conducting research is an employment requirement for 18% of survey participants. Twenty-nine percent of respondents have published at least one research article, and 47% of respondents who conduct research have published studies in the journal Clinical Laboratory Science. More than 57% of respondents participate in non-research scholarly activities as part of their employment. CLS professionals who conduct research are more likely to do applied, clinical, or educational research than other types of research. Fifty-seven percent of respondents who conduct research lack external funding for their work. Ninety-three percent of total research dollars is obtained by respondents who hold the Ph.D. degree. The perception of the importance of conducting research varies by employment position. Barriers to participation in research include lack of inclusion of research in the job description, time constraints, inadequate research funding, limited opportunity, and lack of space and equipment., Conclusions: CLS professionals participate in research in limited numbers, and are more likely to engage in non-research types of scholarly activities. Numerous barriers are identified which impose limits to conducting research. Over half of CLS's research efforts lack external funding. Although there was broad representation among participants across educational levels, employment settings, and job positions, the number of survey respondents was limited. Possible directions for future research include conducting this survey using members of additional professional organizations.

A survey was conducted among 130 New York State (NYS) registered cytology laboratories to better understand current and future changes in the practice of cytology, changes in the cytotechnologist (CT) scope of practice, and the future need for CTs. A 51.5% (67/130) response rate was obtained. Trends for gynecologic case volume varied across facility types. Nongynecologic volume is growing primarily in hospitals and large medical center laboratories and private laboratories; the fine-needle aspiration volume is growing in hospital and large medical center laboratories. One third of responding laboratories anticipate a continued demand for CTs within the next 3 years owing to impending retirements. Few laboratories also report the gradual adoption of molecular testing with CTs directly involved. Because 60% (3/5) of NYS CT training programs have closed since 2008, the 2 remaining programs are a valuable key staffing resource for CTs. Continued viability of these programs is essential to provide the necessary training and staffing of NYS laboratories for cytopathology practice.

Because of a growing need for good quality and safety in medical care, it is necessary for clinical laboratories to improve quality and competence, and for these improvements to be disclosed to clinicians and patients. To this end, each clinical laboratory should be evaluated and accredited by an international third-party organization. We, the Department of Clinical Laboratory, the University of Tokyo Hospital, achieved ISO15189 accreditation in January 2007. Thereafter, the Department of Blood Transfusion, the Department of Infection Control, and our system for specified health checkup also obtained ISO15189 accreditation in March 2008. Based on this ISO15189 accreditation, quality-certified laboratory test results are now reported and, therefore, clinicians can perform safe medical care for their patients. Furthermore, ISO15189 is useful for clinical trials and international collaboration in medical research. We hope our ISO15189 accreditation will be helpful in its dissemination in Japan, thereby playing a role in clinical laboratory standardization, benefiting both clinicians and patients.

The microbiology laboratory of our university hospital aims to provide accurate and rapid microbiological results and useful information for healthcare workers involved in both the treatment of infectious diseases and infection control. For this purpose, we have been running a microbiology laboratory open 365 days a year since 2005. Before starting this laboratory, we formulated both a precise procedural manual and educational program to increase the number of microbiological technologists from 4 to 8 persons and improve their skills. Moreover, we reviewed the reporting system. As a result, we could report positive blood cultures up to 1.4 days earlier than previously possible, and significantly improved the prognosis of MRSA bacteremia patients by the early treatment of anti-MRSA antimicrobials within 48 hours after positive blood culture. In addition, the rate of MRSA/Staphylococcus aureus decreased to 35.8%. It is essential for the treatment of infectious diseases and infection control to accept only appropriate specimens and report the results rapidly and accurately.

According to conception of evolution of the service of clinical laboratory diagnostics of RF for period 2003-2010, "the laboratory service requires a grand reorganization and correction of some sections with a glance to maximal possible economical expenses, connected with re-equipment of clinical-diagnostic laboratories, in conditions of improvement of theirs diagnostic effectiveness". The conception is elaborated in accordance to active legislation of RF and to the resolution of "Conference of main specialists in the sphere of clinical laboratory diagnostic" of constituent of the Russian Federation from 17.04.2002. The article presents a survey of problems, existing in laboratory service of the central hospital, and ways of theirs solving.

To face the economic pressures arising from the current socio-economic conjuncture, hospital laboratories are endangered by an increasing trend towards the outsourcing of clinical laboratory tests to external (mega-) laboratories. This should allow hospitals to meet their economic requirements, but with an increased risk of loss of medical quality and, mid- to long-term, loss of cost effectiveness of healthcare at the national level. To anticipate current developments (economical and technological) that inevitably will affect the future of laboratory medicine, hospital laboratories should be proactive and enhance efficiency, reduce costs by consolidation, integrate into regional networks, and form alliances or partnerships. To create additional value, the core competency of laboratory professionals must be refocused to provide medical knowledge services (consultative support to clinicians) related to in vitro diagnostic testing. To integrate cost-efficiency with medical quality, implementation of a matricial organization - operational vs. biomedical level - could be an interesting approach. This integrated structure should create total quality of laboratory testing, managing the entire medical diagnostic cycle from the pre-preanalytical to post-postanalytical phase.

Since the completion of the human genome project, there is growing interest in the clinical application of genome sciences. For this purpose, particular attention toward identifying at-risk individuals and understanding the complexities of the testing process are essential. In this article, I describe the importance of clinical genetics and genetic counseling, and explain how and why the division of laboratory medicine is involved in these tasks in Chiba University Hospital. Our genetic counseling team consists of a clinical laboratory physician qualified as a clinical geneticist, medical technologist qualified as a genetic counselor, clinical psychologists, and a medical social worker. We treat more than 100 cases including late-onset, incurable neurological diseases, hereditary tumors, prenatal diagnosis, and chromosomal abnormalities. The sequencing of the human genome has paved the way for comprehensive transcriptome and proteome analyses. Since the detailed understanding of biological processes, both in healthy and pathological states, requires the direct study of relevant proteins, proteomics bridges the gap between the information coded in the genome sequence and cellular behavior. Therefore, proteomics is among the most promising technologies for the development of novel diagnostic tools. Recent advances in sophisticated technologies in proteomics should identify promising ways to discover novel markers in various fields of clinical medicine. In this presentation, I will give a definition of the proteome, and outline the basic methodologies for proteome analyses. I will also present our experiences in identifying novel biomarker candidates in hepatobiliary diseases, and discuss future perspectives of clinical proteomics in laboratory medicine.

Medline research indicates that an increasing number of manuscripts have been published in the last decade claiming, the feasibility and the potential clinical role of tissue Doppler and strain/strain rate imaging. However, despite this amount of scientific evidence, these technologies are still confined to dedicated, high-tech, research-oriented echocardiography laboratories. In this review we have critically evaluated these techniques, analysing their physical principles, the technical problems related to their current clinical application, and the future perspectives. Finally, this review explores the reasons why these technologies are still defined "new technologies" and the impact of their implementation on the current clinical activity of an echocardiography laboratory.

In September, 2007, the Japanese Ministry of Health, Labor and Welfare legislated that clinical laboratory doctors can advocate the clinical laboratory in hospitals and clinical offices. The decision was monumentous, and we, clinical laboratory physicians, can see patients from April, 2008. Although our roles and/or details have not officially been determined, we must definite the contribution of clinical laboratory doctors. One of our plans is to set up a conference room in the Division of Clinical Laboratory to explain their medical tests to patients. Laboratory data are not always explained in detail by doctors, since they are busy and do not have enough time to see patients. Subsequently, clinical laboratory physicians will be able to comply with patients' wishes for medical testing. In addition, to prevent the development of lifestyle-related diseases and their related metabolic syndrome in Japanese people, a new specified health checkup system has recently been established by the Japanese Ministry of Health, Labor and Welfare, and the system will start from April, 2008. Since more than 20 million people from 40 to 74 years old are estimated to undergo this health checkup, total quality assurance in the clinical laboratory is required to provide accurate and precise test values by the government. Therefore, our clinical laboratory physicians should play a central role to guarantee the specified health checkup system.

Since 1994, at least three national advisory committees have addressed issues involving access to high-quality genetic testing for ultra-rare genetic diseases. These included the Institute of Medicine (1994), a National Institutes of Health-Department of Energy Task Force on Genetic Testing (1997), and the Secretary's Advisory Committee on Genetic Testing (2000). All identified the limited availability of high-quality testing for these rare diseases as a very high priority and a number of recommendations to improve access were made. However, little systematic progress was made as a direct result of these committee recommendations. Beginning in 2004, a series of national workshops on "Quality Laboratory Testing for Rare Diseases" was organized by a group of clinical laboratory directors experienced in rare disease testing working with the Centers for Disease Control and the Office of Rare Diseases at National Institutes of Health. These meetings included broad-based community involvement, with stakeholders from appropriate federal agencies, professional societies, patient advocacy groups as well as clinical geneticists and clinical genetics laboratory experts. Two successful outcomes of these workshops were the formation of a National Laboratory Network for Rare Disease Testing and a National Institutes of Health-funded program to aid in the translation of new genetic tests from research laboratories to Clinical Laboratory Improvement Amendments-certified diagnostic laboratories known as the Collaboration and Education in Test Translation program. This article briefly reviews the history and current status of genetic testing for ultra-rare genetic diseases in the United States, with a primary focus on molecular genetic testing by DNA sequencing. Other articles in this series provide more detailed reports on the significant progress in improving access to quality genetic testing for rare diseases within the last few years.

Background: Availability of point-of-care testing (POCT) technology may lead to unnecessary testing and expense without improving outcomes. We tested the hypothesis that frequency of intraoperative blood testing (IBT) would increase in association with installation of POCT devices in our surgical suites., Methods: We performed a retrospective analysis of 38,115 electronic anesthesia records for cases performed in the 1 yr before and 1 yr after POCT installation. For each case, the frequency of IBT was tabulated and the change in frequency of IBT between the study periods was calculated for individual anesthesiologists, for the department as a whole, and for clusters of anesthetizing locations., Results: For the department as a whole, there was no significant change between the before and after study periods in the 13% proportion of cases in which IBT was obtained. For cases in which IBT was used, there was no significant increase in the number of IBTs per case., Conclusions: We found no significant increase in the overall utilization of IBT associated with POCT presence in noncardiothoracic operating rooms.

Molecular pharmacogenetic units have recently been established in several hospital laboratories in France. The clinical impact of these units is still limited and numerous problems of organizational, ethical, legal, technical, social and economical nature remain to be resolved. However, an increasing number of these units, a rise in their activities and an enlargement of their scope of application are foreseeable in the future. Ultimately, these units would significantly contribute to limit the public health problem caused by interindividual variabilities in drug effects. In view of these prospects, it seems essential that such hospital activity should be quickly recognised by the authorities and the various health sectors in France. It is also essential that the problems that arise from such pharmacogenetic activities should be considered by the authorities and would profit from the organization of a national network and from financial guarantees.

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

Biosafety includes the protective measures against the risks of contamination with pathogen germs in the laboratories that handle pathogens, or stock or manipulate potentially contaminated products, or perform microbiological tests for medical or scientific research purposes, as well as the means of protecting the environment and the human collectivities against hazard contaminations that have as starting point these laboratories. Besides, lately, a new notion emerged, that of biosecurity, which refers to the sum of measures designed to protect workers, environment and population against the loss, theft, use and release in the environment of pathogenic biological agents. The work overviews the present concerns for the regulation of these two notions and the way in which a system for the management of the biological risks in a laboratory that handles pathogens should be documented and implemented. The need for the continuous professional training of the staff and for the establishment of individual and collective responsibilities for preventing biosafety incidents and trespassing biosecurity rules are as well emphasized. The main biosafety measures are pointed out and a series of considerations regarding biosafety and bioterrorism in correlation with the medical laboratory are as well mentioned.