Vitamin K antagonists such as warfarin, which inhibit vitamin K-dependent clotting factors II, VII, IX, and X, have been the only available oral anticoagulants for more than 50 years. Direct oral anticoagulants (DOACs),...Vitamin K antagonists such as warfarin, which inhibit vitamin K-dependent clotting factors II, VII, IX, and X, have been the only available oral anticoagulants for more than 50 years. Direct oral anticoagulants (DOACs), including direct anti-Xa and a thrombin inhibitor, have been introduced and provide advantages over warfarin. DOACs are rapidly-acting, target-specific anticoagulants that inhibit both free and bound activated serine proteases, unlike heparin that can inhibit only free proteases. The FXa inhibitors (Rivaroxaban, Apixaban, Edoxaban) bind directly to the catalytic site of FXa and inhibit both free and prothrombinase-bound FXa. The thrombin inhibitor (Dabigatran), designed to occupy and inactivate the serine proteolytic pocket of thrombin, prevents thrombin from acting on fibrinogen to produce fibrin. Although routine coagulation mon- itoring of DOACs is not required, it may be useful under some circumstances. Several reports have de- scribed the effect of DOACs on routine assays including the APTT and PT. Dabigatran will interfere with most APTT-based and some PT-based assays, which means that laboratory testing will lead to results that are not representative of the physiologic effects. Rivaroxaban and edoxaban prolong the PT to a greater extent than APTT, and these agents may interfere with PT-based factor activity assays (FVII, X, V, and II) causing factitiously low activities. Also discussed are the use of drug-specific assays and alternative meth- ods to determine the relative drug concentration, such as evaluating drug calibrators in APTT and PT assays. The actual drug concentration may be required for specific patients, such as those with deterioration of the renal function, before surgical interventions, bleeding or thrombotic episodes, and suspected overdoses, and to control adherence to therapy. The need to assess DOACs in emergent situations as well as their impact on routine and special coagulation assays has created challenges in most laboratories. [Review] '.
The knowledge and skills of clinical hematology necessary for clinical laboratory medicine are different from the knowledge required for the hematological specialists or general physicians. A wide range of knowledge and...The knowledge and skills of clinical hematology necessary for clinical laboratory medicine are different from the knowledge required for the hematological specialists or general physicians. A wide range of knowledge and comprehensive skills to connect the sub-specialty and hematological specialist are required. To do so, comprehensive understanding such as, (1) how to assess the results of blood testing in a relative- ly frequent disease, (2) understanding of specific diseases that require rapid clinical judgment and consulta- tion, (3) the latest diagnostic techniques, including genetic diagnosis, (4) the knowledge of companion diag- nostic techniques necessary for molecular targeted therapy and molecular immunotherapy, are required. However, it is not easy to understand the rapid progress in diagnostic techniques and treatment strategies even in hematological specialists. Therefore, the following points are presented in the seminar; understand- ing of boundary for normal and abnormal findings, evaluation criteria for rapid assessment and report, the feature of hematological malignancies tight cooperation is needed with hematological specialist. In this paper, the role of the specialists on clinical laboratory medicine as a "mediator" in the clinical hema- tology is summarized, especially in anemia and coagulation disorders. [Review].
The values of free T4 (FT4) and TSH are discrepant depending on reagents. Standardization of testing is crucial because the decision limits in absolute values are described in current clinical practice guidelines. The In...The values of free T4 (FT4) and TSH are discrepant depending on reagents. Standardization of testing is crucial because the decision limits in absolute values are described in current clinical practice guidelines. The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) has worked over the years towards the goal of test standardization. However, it will take several years before implementation becomes effective. Therefore, the standardization committee of the Japanese Society of Laboratory Medi- cine suggested the recalculation of formulas to standardize the value of TSH. These formulas may be used until the standardization of TSH is reached. [Review].
Diabetic nephropathy is one of the major causes of the requirement for renal replacement therapy through- out the world. To overcome diabetic nephropathy, the establishment of adequate clinico-pathological pa- rameters a...Diabetic nephropathy is one of the major causes of the requirement for renal replacement therapy through- out the world. To overcome diabetic nephropathy, the establishment of adequate clinico-pathological pa- rameters and related biomarkers for the diagnosis and/or prognoses is required. Concomitantly, in order to define patients' status, the classification of diabetic nephropathy is widely used in Japan. This was revised by the joint committee on diabetic nephropathy, as Classification of Diabetic Nephropathy 2014, in which the estimated glomerular filtration rate and presence and amounts of albuminuria were graded. Recent progress revealed the remission and/or regression of diabetic nephropathy, which may be closely related to a better prognosis following cardiovascular and renal events. Further insights are needed into clinico-pathological characteristics in terms of laboratory medicine for early and specific diagnoses, as well as those on renal and cardiovascular outcomes. [Review].
Inappropriate antimicrobial therapy is associated with a worsening prognosis, and the increasing prevalence of multidrug-resistance organisms has led to significant threats to clinical practice. Bacterial identification...Inappropriate antimicrobial therapy is associated with a worsening prognosis, and the increasing prevalence of multidrug-resistance organisms has led to significant threats to clinical practice. Bacterial identification and antimicrobial susceptibility testing (AST) are crucial tools for the treatment of bacterial infections. However, information regarding bacterial identification or AST is generally unavailable for clinical decisions regarding treatment for at least two days. Matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS) and genetic diagnosis are expected to be newer rapid diagnostic tests for infectious diseases, which contribute to the decision regarding appropriate antimicrobial agents. [Review].
We published a guideline for clinical laboratory tests (JSLM 2015) in November 2015. This guideline is unique regarding its multi-disciplinary character, compared with most guidelines from scientific groups that were dev...We published a guideline for clinical laboratory tests (JSLM 2015) in November 2015. This guideline is unique regarding its multi-disciplinary character, compared with most guidelines from scientific groups that were developed to answer specific clinical questions or overcome problems that were not easily solved by reviewing standard references or textbooks. On the other hand, the JSLM guideline and committee of this publication were developed in response to the introduction of the prospective payment system (DRG/PPS or DPC: diagnosis procedure complex) in Japanese healthcare insurance. We needed a resource explaining the "selection of laboratory tests in a clinically effective and also economically reasonable way". The committee was founded in 1988, and the guideline was provided in 1989 as a draft. "JSLM 2015" is the seventh version of this laboratory test guideline, and the contents have been updated to be consistent with the latest concept in the wide area of clinical medicine. Because laboratory medicine has to cover a very wide clinical area, it is often difficult for laboratory physi- cians, or those with a similar profession, to have specific subspecialty knowledge to be able to deal with all specific problems raised in clinical laboratory facilities. We developed the guideline under the concept of providing "a resource to meet the least minimum requirement in everyday performance of laboratory medi- cine", and we believe that this guideline will compensate for the lack of knowledge required for the resolution of all problems in the clinical laboratory. [Review].
The scope of the biomedical laboratory scientist (BLS) differs in the world. The qualification systems for BLS are also different. Even the name of our profession is not standardized, like "BLS", "Medical Technologist (M...The scope of the biomedical laboratory scientist (BLS) differs in the world. The qualification systems for BLS are also different. Even the name of our profession is not standardized, like "BLS", "Medical Technologist (MT) ", "Medical Laboratory Scientist (MLS) ", "Medical Technician", and so on. We have only the "BLS" license, which is recognized by the Ministry of Health, Labour and Welfare in Japan. Many Asian countries have a qualification system similar to Japan. In the USA, BLSs are qualified by certain scientific organizations, and they are called "MT", "BLS", or "Specialist" in consideration of their education level. The International Association of Medical Laboratory Technologists (IAMLT) was founded by Ms. Elizabeth Pletscher and her Swiss colleagues in order to cooperate with international BLSs in 1954. Since the BLS education system has been improved, chief delegates from the world decided that we should call ourselves "BLS", and IAMLT was revised to the "International Federation of Biomedical Laboratory Science (IFBLS) " at the general assembly in 2002. IFBLS has tried to spread our name and occupation to the public though our international cooperation using the same name "BLS". IFBLS shares the core competence, but does not provide certification. The International Academy of Clinical Cytology (IAC) has provided international certification for cytolo- gists and cytotechnologists. The American Society of Clinical Pathology (ASCP) has certified overseas BLSs (ASCPi), and they are able to work in the USA as BLSs after passing the examination. These certifi- cations will be valid in limited areas. As the current situation, if someone would like to work in another country as a BLS, he/she will have to pass the domestic BLS examination. [Review].
Clinical applications of molecular-genetic testing are rapidly disseminating and expanding. A qualification system of technological professionals for molecular-genetic testing has been implemented and operating in Japan,...Clinical applications of molecular-genetic testing are rapidly disseminating and expanding. A qualification system of technological professionals for molecular-genetic testing has been implemented and operating in Japan, aiming at educating and evaluating personnel who are to engage in molecular-genetic testing. It con- sists of two stages in career development with molecular analysis technologist and specialist, both of which need to be renewed every 5 years. The qualification is of significance across many fields. Human resource development of molecular-genetic testing is a cornerstone of quality assurance of measurement by medical and research laboratory personnel. In addition, expectations of the qualified personnel include the manage- ment of relevant guidelines, compliance regarding the use of personal genetic information (medical ethics) and bio-risk in the laboratories, as well as engagement in the biotechnology industry. [Review].
The three types of certifying examinations provided by the College of Laboratory Medicine of Japan are introduced. They are the Technologist in Laboratory, Specialist in Laboratory, and Technologist in Emer- gency Labora...The three types of certifying examinations provided by the College of Laboratory Medicine of Japan are introduced. They are the Technologist in Laboratory, Specialist in Laboratory, and Technologist in Emer- gency Laboratory. Both the Technologist in Laboratory and Specialist in Laboratory examinations focus on eight areas: microbiology, pathology, chemistry, hematology, immunology, cardiology, neurology, and respi- rology. The Technologist in Laboratory examination started in 1954, and, as of today, it has been passed by 34,646 people. The Specialist in Laboratory examination started in 1956, and due to its level of difficulty, it has been passed by only 232 people. Meanwhile, the Technologist in Emergency Laboratory examination start- ed in 1992, and it has been passed by 5,047 people. These certificates prove that their holders have acquired a certain level of knowledge and technical aptitude, and that they represent the caliber of personnel necessary for clinical laboratories to obtain facility authentication from organizations such as the International Organiza- tion for Standardization (ISO) and the College of American Pathologists (CAP). Therefore, the significance and value of acquiring these qualifications are marked. [Review].
The symposium was cosponsored by the College of Laboratory Medicine of Japan (CLMJ). Two main top- ics were discussed in it. One was for clinical laboratory physicians, and the other was for medical technolo- gists. Rega...The symposium was cosponsored by the College of Laboratory Medicine of Japan (CLMJ). Two main top- ics were discussed in it. One was for clinical laboratory physicians, and the other was for medical technolo- gists. Regarding the former theme, a lecture was held about the medical specialist system beginning in the 2017 fiscal year, and the educational steps for becoming a clinical laboratory physician in the system. Re- garding the latter, four lectures were held, 1. Post-graduate education for medical technologists and the role of the Japanese Association of Medical Technologists, 2. Certification examinations by CJMJ, 3. Certification examinations by the College of Molecular Analysis, 4. Certification systems in foreign countries. We hope that this symposium can promote understanding of post-graduate education for clinical laboratory physicians and medical technologists, leading to career improvement. [Review].
The International Committee of the Japanese Society of Laboratory Medicine (JSLM) has established an encouragement award for young scientists to present papers at international conferences, such as the World Congresses o...The International Committee of the Japanese Society of Laboratory Medicine (JSLM) has established an encouragement award for young scientists to present papers at international conferences, such as the World Congresses of the World Association of Societies of Pathology and Laboratory Medicine (WASPaLM) and the Meetings of the Asian Society for Clinical Pathology and Laboratory Medicine (ASCPaLM). JSLM has promoted cooperation with international organizations for clinical pathology and laboratory medi- cine, including WASPaLM and ASCPaLM. The 32nd World Congress of Biomedical Laboratory Science, IFBLS2016, will be held in Kobe, Japan from August 31st to September 4th, 2016. The 29th World Con- gress of WASPaLM will be held in Kyoto, Japan from November 14th to 19th, 2017. Continuous efforts will be required for JSLM to promote education, research, and international quality standards though cooperation with international organizations for clinical pathology and laboratory medicine. [Review].
In Japan, a medical laboratory accreditation program has been implemented on the basis of the international standard ISO 15189 (Medical laboratories-requirements for quality and competence), under the cooperation of the...In Japan, a medical laboratory accreditation program has been implemented on the basis of the international standard ISO 15189 (Medical laboratories-requirements for quality and competence), under the cooperation of the Japanese Committee for Clinical Laboratory Standards (JCCLS) and the Japan Accreditation Body (JAB). It is carried out in accordance with the specific guidance document 'Guide RM300: 2014'. The subject in the accreditation program is currently limited to common laboratory tests, which are covered by medical insur- ance, with regulatory approval. The 2012 version of ISO 15189 (ISO 15189:2012) expanded its scope, cover- ing genetic testing. In order to achieve the purpose of a clinical research core hospital that has recently been established in Japan, there is a need for an accreditation program to cover the lack of insurance coverage, such as molecular-genetic testing based on emerging technologies. To this end, the development of guid- ance documents intended for genetic testing by which medical laboratories can implement a quality system to meet ISO 15189:2012 is to be considered. In addition, it is necessary to secure human resources who are familiar with oversight and inspection regarding genome-specific matters. [Review].
The Japanese Association of Medical Technologists (JAMT) has joined the International Federation of Bi- omedical Laboratory Science (IFBLS) and Asia Association of Medical Laboratory Scientists (AAMLS). JAMT has conclude...The Japanese Association of Medical Technologists (JAMT) has joined the International Federation of Bi- omedical Laboratory Science (IFBLS) and Asia Association of Medical Laboratory Scientists (AAMLS). JAMT has concluded an agreement with the Korean Association of Medical Technologists (KAMT) and coop- erates with the Japan International Medical Technology Foundation (JIMTEF). In addition, JAMT is prepar- ing for the 32nd World Congress of Biomedical Laboratory Science. JAMT founded an international section for globalization, and started the foundation of an overseas short- term program for studying abroad, exchange with the Taiwanese Association of Medical Technologists (TAMT), and support for developing countries. From an academic aspect, we placed the "Japanese Journal of Medical Technology" on the J-STAGE. JAMT nurtures global medical technologists through international exchanges and support from developing countries. [Review].
Nowadays, global consciousness is important for the human race. Many Japanese businesspersons and even students try to improve their foreign language skills, and try to get a chance to join international activities. Inte...Nowadays, global consciousness is important for the human race. Many Japanese businesspersons and even students try to improve their foreign language skills, and try to get a chance to join international activities. International Activities of BLSs are as follows: 1. Apply for the Japan International Cooperation Agency (JICA) business for supporting developing countries as a technical expert. Since JICA activity is supported by the Japanese Government, it must be worthwhile and will complete large-scale business. After the completion, it might be difficult to find a good work place to utilize JICA ex- perience. 2. Study abroad such as joining an exchange program, or working as a researcher or trainee. Some Japanese institutes provide systems for studying abroad for BLSs. We should study language and improve our professional skills. An employer might give permission for a short stay easily. Support from a supervisor is important. 3. Overseas occupation. We will need certification or a license when we work abroad. Study or work abroad is a precious experience. We should be clear on the purpose and select a suitable place with a long-term plan. Among international activities, it is easy to be a presenter at the World Congress. There are many inter- national congresses for BLSs such as the IFBLS World Congress, AAMLS Congress, or Scientific Congress for each special filed. We should learn not only language, but also different cultures and international man- ners when we participate in international activities. Supervisors can help to improve the global perspective of young BLSs. [Review].
At the 62nd Annual Meeting of the Japanese Society of Laboratory Medicine Scientific Sessions, a "promotion of globalization in clinical laboratory area" symposium of the Japanese Society of Laboratory Medicine (JSLM) an...At the 62nd Annual Meeting of the Japanese Society of Laboratory Medicine Scientific Sessions, a "promotion of globalization in clinical laboratory area" symposium of the Japanese Society of Laboratory Medicine (JSLM) and the Japanese Association of Medical Technologists (JAMT) was held. Studying abroad as well as the overseas dispatch of biomedical laboratory scientists have increased in re- cent years. However, there are still a number of problems. Both the JSLM and JAMT are focusing on in- ternational activities. For example, the JSLM has the International Committee, and the JAMT has set up a specially appointed Executive Director of International Affairs. Moreover, international standards, facility certification, and clinical trials are being established at the clinical laboratory. In other words, there is a growing need for the third-party evaluation of such international certification. The promotion of globaliza- tion in the clinical laboratory area is essential, and human resource development to nurture an international community in the future is important. However, the most important thing is that many biomedical laborato- ry scientists participate in international conferences. [Review].
We have developed a certification system with objective scoring criteria to evaluate blood sampling techniques. Criteria included not only outcome evaluations, but process-oriented approaches and taxonomy in three fields...We have developed a certification system with objective scoring criteria to evaluate blood sampling techniques. Criteria included not only outcome evaluations, but process-oriented approaches and taxonomy in three fields. After introduction of this system, the time required for blood sampling was reduced and the attitudes of the medical technologists toward patients and blood sampling techniques improved. All members in our labora- tory department were involved in the establishment of this unique system. This system for medical tech- nologists was remarkably useful for education of blood sampling techniques. [Short Communication].
Ebashi M, Oinuma H, Hidaka Y
… +3 more, Koibuchi H, Kotani K, Yamada T
Rinsho Byori
· 2016 Aug · PMID 30609325
The amount of monoclonal immunoglobulin (M protein) distinguishes multiple myeloma (M) from mono- clonal gammopathy of undetermined significance (MGUS) and indicates the effectiveness of treatment for MM. It should be ca...The amount of monoclonal immunoglobulin (M protein) distinguishes multiple myeloma (M) from mono- clonal gammopathy of undetermined significance (MGUS) and indicates the effectiveness of treatment for MM. It should be calculated by serum total protein (g/dL) and M peak ratio (%) on the densitometry of se- rum electrophoresis. However, the ordinary method possibly overestimates the amount of M protein, be- cause this method utilizes the area from the baseline of the M peak (baseline method). For the more accu- rate measurement of M protein, in this study, we evaluated a capillary electrophoresis system that enables to extract the proper area of M peak by manual operation (peak method). Three serum samples with positive M protein were mixed with M protein negative serum at various ratio, and the measured values of M protein were compared with the theoretical values for both baseline and peak methods. All the results showed that the peak method gave the values close to the theoretical values compared with the baseline method. Espe- cially, the less M protein positive serum was mixed, the further the values by the baseline method parted from the theoretical one. In conclusion, the peak method using a capillary electrophoresis system should be introduced for the accurate quantification of M protein. [Original].
Mori S, Morinaga Y, Nishimura F
… +10 more, Murata M, Umihata S, Sasaki D, Kaku N, Kosai K, Uno N, Taguchi J, Hasegawa H, Miyazaki Y, Yanagihara K
Rinsho Byori
· 2016 Aug · PMID 30609324
The accurate and standardized diagnosis of cytomegalovirus (CMV) infection is important for immunocom- promised patients. We prospectively evaluated the performance of an automated and standardized real-time polymerase c...The accurate and standardized diagnosis of cytomegalovirus (CMV) infection is important for immunocom- promised patients. We prospectively evaluated the performance of an automated and standardized real-time polymerase chain reaction (PCR) -based DNA quantification for the detection of CMV. The results of PCR- based analysis were also compared with pp65 antigenemia (Ag) assay in the clinical records. The PCR- based analysis of 144 plasma samples from 26 patients with hematologic diseases detected CMV in 69 (48.0%) samples (range, <150-1.28 X 10⁴ copies/mL) while Ag detected CMV in 32(22.2%) samples (range, 1-37/50,000 cells). The number of concordant samples between the two tests was 95(66.0%). There were nine patients who had an Ag-positive period sandwiched by Ag-negative periods and, in all these patients, the Ag-positive period was completely covered by PCR-positive period. These results suggest that PCR can detect CMV more sensitively than Ag. The automated and standardized PCR for detection of CMV can support the appropriate management in patients with risks of CMV infection. [Original].
In order to provide safe and secure medical care for patients, health care-associated infections (HAI) must not occur. HAI should be considered as incidents, and countermeasures should be viewed as a patient safety manag...In order to provide safe and secure medical care for patients, health care-associated infections (HAI) must not occur. HAI should be considered as incidents, and countermeasures should be viewed as a patient safety management itself. Healthcare-associated infection control (HAIC) is practiced by the infection control team (ICT), which is based on multidisciplinary cooperation. Team members have to recognize that it is the most important to make use of the expertise of each discipline. In addition, all members must try to respond quickly, to help the clinic staff. Visualized rapid information provision and sharing, environmental improvement, outbreak factor analysis, hand hygiene compliance rate improvement, proper antibiotic use (Antimicrobial Stewardship Program: ASP), and regional cooperation & leadership comprise the role of the ICT in the flagship hospital. Regarding this role, we present our hospital's efforts and the outcomes. In conclusion, for medical practice quality improvement, healthcare-associated infection control should be conducted thoroughly along with an awareness of patient safety.
Healthcare-associated infection control aims to protect patients and health care workers from infections. For successful control, it is important not to transmit pathogens and resistant bacteria as well as not to create...Healthcare-associated infection control aims to protect patients and health care workers from infections. For successful control, it is important not to transmit pathogens and resistant bacteria as well as not to create new resistant bacteria. Preventing the transmission of pathogens and resistant bacteria involves the reliable implementation of preventative measures for specific pathways in response to the causative microorganism. Appropriate information from the microbiology laboratory promotes the thorough implementation of prevention measures. This laboratory also makes it possible to promptly understand data on infections for the whole hospital. Therefore, in addition to the normal reporting of results, surveillance reports of infectious agents, such as drug-resistant bacteria, acid-fast bacilli smear-positive patients, and influenza virus antigen-positive patients must be immediately reported to the infection control team (ICT), which is the unit responsible for infection control. In addition, it is important to provide information on the detection of resistant bacteria and antimicrobial susceptibility rates to clinical staff and promote the development of systems in which new resistant bacteria are not created.