[Future roles of clinical laboratories and clinical laboratory technologists in university hospitals].

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.

Seeking answers in a genetic code. Some hospitals plunge into genome sequencing despite concerns about evolving knowledge, clinical benefit and costs.

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.

Use, location, and timeliness of clinical microbiology testing in Georgia for select infectious diseases.

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.

Research in clinical laboratory science: professionals' involvement.

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.

[Role and future aspects of hospital clinical laboratories in medical team approaches].

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.

[Current realities and problems in the clinical laboratory as a medical care support department at the Hirosaki University Hospital].

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.

[Consider the advantages and disadvantages of microbial examinations in a hospital, and ideal microbial laboratory].

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.

COVID-19 Pandemic Planning: Simulation Models to Predict Biochemistry Test Capacity for Patient Surges.

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.

[Overview of ISO15189 and accreditation with it].

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.

Global impact of the COVID-19 pandemic on cytopathology practice: Results from an international survey of laboratories in 23 countries.

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.

Description of a new biosafe procedure for cytological specimens from patients with COVID-19 processed by liquid-based preparations.

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.

The future of hospital laboratories. Position statement from the Royal Belgian Society of Clinical Chemistry (RBSCC).

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.

[Establishment of a microbiology laboratory open 365 days a year and its impact].

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.

[Laboratory service of the P V Mandryka Central Military Clinical Hospital: problems and perspectives].

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.

Issues in genetic testing for ultra-rare diseases: background and introduction.

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.

Tissue Doppler and strain imaging: anything left in the echo-lab?

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.

[Laboratory medicine in the post-genome era: experiences in Chiba University Hospital].

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.

[How can we contribute to Yamagata University Hospital as clinical laboratory physicians?].

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.

Laboratory investigations in uveitis: current practice and future directions.

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.