Microbiological tests and the reimbursement of medical fees in Japan

Microbiological tests are important for the diagnosis of infectious diseases and their follow-ups. Under the medical reimbursement system, Gram staining has been approved as a fast laboratory test for outpatients, and remuneration for the management of laboratory testing is also applied to it. On the other hand, a serious problem in conducting microbiological testing is unprofitability, including high personnel costs and expenses for reagents. We conducted a survey involving eight medical institutions of the costs for Gram staining, bacterial culture and identification, anaerobic culture, antimicrobial susceptibility testing, isolation culture of acid-fast bacteria, and testing for susceptibility to antimycobacterial agents. The mean costs for all these items were higher than medical service fees. Even after the previous revision of the medical fee and increases in service fees, the operations of the above-mentioned tests still remain unprofitable. The Japanese Promotion Council for Laboratory Testing has been involved in ensuring appropriate reimbursement of medical fees. The council conducted surveys and assessments of costs for laboratory tests and their clinical values, and submitted a request to the Ministry of Health, Labour and Welfare for an improvement in the medical treatment fees. In response to our request, there were increases in some medical service fees, including the increase from 170 to 400 yen for Gram staining. It is important to continue to ask relevant government agencies to ensure appropriate remuneration for microbiological testing based on objective data.     

Rapid diagnostic tests for infectious diseases in the emergency department

BackgroundRapid diagnostic tests (RDTs) for infectious diseases, with a turnaround time of less than 2 hours, are promising tools that could improve patient care, antimicrobial stewardship and infection prevention in the emergency department (ED) setting. Numerous RDTs have been developed, although not necessarily for the ED environment. Their successful implementation in the ED relies on their performance and impact on patient management.ObjectivesThe aim of this narrative review was to provide an overview of currently available RDTs for infectious diseases in the ED.SourcesPubMed was searched through August 2019 for available studies on RDTs for infectious diseases. Inclusion criteria included: commercial tests approved by the US Food and Drug Administration (FDA) or Conformité Européenne (CE) in vitro diagnostic devices with data on clinical samples, ability to run on fully automated systems and result delivery within 2 hours.ContentA nonexhaustive list of representative commercially available FDA- or CE-approved assays was categorized by clinical syndrome: pharyngitis and upper respiratory tract infection, lower respiratory tract infection, gastrointestinal infection, meningitis and encephalitis, fever in returning travellers and sexually transmitted infection, including HIV. The performance of tests was described on the basis of clinical validation studies. Further, their impact on clinical outcomes and anti-infective use was discussed with a focus on ED-based studies.ImplicationsClinicians should be familiar with the distinctive features of each RDT and individual performance characteristics for each target. Their integration into ED work flow should be preplanned considering local constraints of given settings. Additional clinical studies are needed to further evaluate their clinical effectiveness and cost-effectiveness.     

Development, implementation, and impact of acceptability criteria for serologic tests for infectious diseases

Serologic testing is essential for the diagnosis of some infectious diseases and yet is fraught with potential pitfalls. All parts of the diagnostic process must be optimized to ensure that serologic tests perform adequately. Recognizing that a lack of clinical data and correctly timed, paired sera frequently led to uninterpretable serology results at our laboratory, we developed and implemented simple acceptability criteria for serologic tests. We assessed the impact of these criteria by comparing submissions and results for the year before and the year after implementation of the criteria. The number of serologic tests performed declined by 25% after implementation of the acceptability criteria, despite an increase in requests for serologic tests. Inappropriate testing of acute-phase sera alone fell from 49 to 0% (P < 0.001) for the tests monitored. Appropriate submission of paired sera rose from 9 to 19% (P = 0.006). The proportion of results classified as interpretable rose from 52 to 100% (P < 0.001). We recommend that acceptability criteria be developed and applied to samples submitted to clinical microbiology laboratories for serologic testing.     

Helicobacter pylori test and medical reimbursement

There are an estimated 60 million people with Helicobacter pylori(H. pylori) infection who occupied 50% of the population of Japan. In Japanese medical reimbursement H. pylori tests were introduced on November 1, 2000 and they are able to use only to patients with gastric and duodenal ulcer. H. pylori tests were composed of rapid urease test, urea breath test, antibody test, bacterial culture and pathologic test. Payment of each test is 700 Yen. Classification and cost of H. pylori tests are shown. Usage of laboratory tests for H. pylori infection is mentioned. Those particular tests are useful to decrease the number of gastric and duodenal ulcer in Japan.     

Choosing effective laboratory tests for hyperlipidemia, and the reimbursement system

The Japanese Government has developed health-care payment policies designed to balance the growth of health-care expenditure against other national priorities. Often these policies tend to limit the various services. The Japan Atherosclerosis Society published management guidelines for hyperlipidemia in 1997. There is increasing concern about the cost of laboratory studies as well as the cost of the management of hyperlipidemia. The Japanese Society of Laboratory Medicine has also developed standards to choose effective laboratory tests for general practitioners. Health professionals must have a clear knowledge of not only the clinical significance of the laboratory tests but also of the reimbursement system in order to understand the economic factors that control the services available to their patients. Both knowledge can make the physicians proper medical services for the patients.     

Prostate cancer test and medical reimbursement]

Until now there have been three diagnostic tests, prostate specific antigen (PSA, total PSA), gamma-seminoprotein (gamma-Sm), and prostate acid phosphatase (PAP), for prostate cancer. Recent progresses in utilization of PSA has resulted in two advanced tests, PSA-alpha 1 antichymotrypsin complex (PSA-ACT) and free PSA/total PSA ratio. Payment of each test ranges from 210 to 320 yen. The same as for other cancer tests, three tests is paid 440 yen, and four or more is paid 590 yen. To determine the cost effective choice, it is necessary to consult with appropriate urologists.     

Salmonella-based vaccines for infectious diseases

The use of Salmonella spp. as a delivery system for foreign antigens represents a unique opportunity for the development of ideal vaccines with unparalleled merits. Increased understanding of the mechanisms underlying Salmonella virulence and host immune response will continuously create novel strategies for more effective Salmonella-based vaccines. However, limitations in our capability to manipulate the genome of a vector strain efficiently have delayed the realization of vaccination ideas. Owing to the development of new technologies in recent years, it has now become feasible to rapidly construct Salmonella vaccine strains that carry precise modifications on the chromosomal DNA. This technical advancement will open a new avenue for the effective development of Salmonella-based vaccines for infectious diseases of both human and animal health importance.     

Training and assessment of medical specialists in clinical microbiology and infectious diseases in Europe

BackgroundThere is wide variation in the availability and training of specialists in the diagnosis and management of infections across Europe.ObjectivesTo describe and reflect on the current objectives, structure and content of European curricula and examinations for the training and assessment of medical specialists in Clinical (Medical) Microbiology (CM/MM) and Infectious Diseases (ID).SourcesNarrative review of developments over the past two decades and related policy documents and scientific literature.ContentResponsibility for curricula and examinations lies with the European Union of Medical Specialists (UEMS). The ID Section of UEMS was inaugurated in 1997 and the MM Section separated from Laboratory Medicine in 2008. The sections collaborate closely with each other and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID). Updated European Training Requirements (ETR) were approved for MM in 2017 and ID in 2018. These comprehensive curricula outline the framework for delivery of specialist training and quality control for trainers and training programmes, emphasizing the need for documented, regular formative reviews of progress of trainees. Competencies to be achieved include both specialty-related and generic knowledge, skills and professional behaviours. The indicative length of training is typically 5 years; a year of clinical training is mandated for CM/MM trainees and 6 months of microbiology laboratory training for ID trainees. Each Section is developing examinations using multiple choice questions to test the knowledge base defined in their ETR, to be delivered in 2022 following pilot examinations in 2021.ImplicationsThe revised ETRs and European examinations for medical specialists in CM/MM and ID provide benchmarks for national authorities to adapt or adopt locally. Through harmonization of postgraduate training and assessment, they support the promotion and recognition of high standards of clinical practice and hence improved care for patients throughout Europe, and improved mobility of trainees and specialists.     

Choosing effective laboratory tests for diabetes care, and the reimbursement system]

Diabetes mellitus is a prototype chronic disease. The number of patients with diabetes in Japan is estimated to be about 6.9 million. Expenditure for diabetes care is increasing rapidly and this increase imposes a major economic burden. The Japanese Government has developed health-care payment policies designed to balance the growth of health-care expenditure against other national priorities. Often these policies tend to limit the various services. The Japan Diabetes Society(JDS) published management guidelines for diabetes for general practitioners in 1999. There is increasing concern about the cost of laboratory studies, including self-monitoring blood glucose(SMBG), as well as the cost of general diabetes care. The Japanese Society of Laboratory Medicine(JSLM) has also developed standards to choose effective laboratory tests for general practitioners. Health professionals must have a clear knowledge of the reimbursement system in order to understand the economic factors that control the services available to their patients. Ideally, however, the reimbursement system should meet the financial needs of the services necessary to conform to the professional consensus of the acceptable quality of care for people with diabetes.     

Malassezia infectious diseases

Although Malassezia yeasts are a part of the normal microflora, under certain conditions they can cause superficial skin infection Pityriasis versicolor, Malassezia folliculitis. Lipophilic yeasts are being considered as major opportunistic pathogens for a very long time. Most of the yeasts show an absolute requirement for long fatty acid chains and specific procedures are required for their isolation, conservation and identification. To date, the genus is composed of one non lipid-dependent species M. pachydermatis and lipid-dependent species M. furfur, M. sympodialis, M. globosa, M. obtusa, M. restricta, M. slooffiae, M. dermatis, M. yamatoensis, M. japonica, M. nana, M. caprae, M. equina, M. cuniculi.     

Laboratory logistics for infectious diseases--from clinical laboratory physicians

The diagnosis of bacterial meningitis rests on examination of the CSF. The gross appearance of the fluid may be cloudy or turbid if the white cell count is elevated. Gram's staining should always be used in examining CSF, as it permits rapid and accurate identification of the etiologic agent in approximately 60 to 90 percent of cases of bacterial meningitis. The CSF culture is positive in approximately 70 to 85 percent of patients with bacterial meningitis. Many other rapid diagnostic tests have been developed to aid in the diagnosis of bacterial meningitis when Gram's staining gives negative results. Nevertheless, newer techniques are more rapid and sensitive, postgraduate training in laboratory medicine should include basic clinical skills (Communication skills, physical examination and common laboratory procedures such as Gram's stain, Wright-Giemsa stain, etc.) and 24 hours on-call service system by laboratory physicians. It must not be focused solely on the sophistication of laboratory methods. We must notice that an increasing gap between the clinic and the laboratory. Current needs require us to make a major attempt to bridge this gap. We, laboratory physicians must modify our behavior effectively and accept the value and limitations of laboratory automation and information technology. We must work more closely with physicians and other health care professionals to establish a good collaborative partnership with them.     

Precipitation test for infectious mononucleosis and enterovirus diseases

An extract of bovine kidney obtained by trypsin digestion was used in double diffusion gel precipitation tests. Positive results were obtained with seven of twenty-seven infectious mononucleosis sera, five of twenty-five sera of patients with enterovirus diseases, and with only two of sixty normal human sera.

The precipitating factor was unrelated to heterophile antibodies detectable by sheep cell haemagglutination and ox cell haemolysis. On the other hand, the precipitating factor appeared to be closely related to the serum factor previously demonstrated by mixed agglutination reactions with bovine kidney cell cultures.

     

Strategy for teaching radiology in a medical residency programme in infectious diseases construed through qualitative research

IntroductionTo understand the perspectives of infectious disease residents and their preceptors on teaching radiology in medical residency programmes in this speciality. The aim is to support the creation of a strategy to facilitate teaching and promote learning within the competency matrix, given the expanding role of diagnostic imaging methods in medicine. Thus, knowledge of radiology is an increasingly useful tool for professional practice in the area of infectious diseases.Material and methodsThis is a qualitative, exploratory investigation in which semi-structured interviews were conducted with resident physicians and preceptors of a medical residency programme in infectious diseases according to the paradigmatic approach of Foucault’s discourse analysis.ResultsBased on analysis of the interviews, the following central points are considered in developing a strategy to teach radiology in the medical residency programme in infectious diseases: understanding of the vocabulary used in radiology, development of good communication skills with radiologists, optimising the time dedicated to learning radiology, the correlation between aspects of radiology and anatomical pathology, as well as the systematisation of a teaching process.ConclusionThe appreciation for peer education and case discussions, particularly with a radiologist integrated into the medical residency team, indicate that these are the measures with the greatest potential to facilitate teaching and promote learning.     

Emerging and re-emerging infectious diseases

In human history, numerous infectious diseases have emerged and re-emerged. Aside from many others, the so-called 'exotic' agents in particular are a threat to our public health systems due to limited experience in case management and lack of appropriate resources. Many of these agents are zoonotic in origin and transmitted from animals to man either directly or via vectors. The reservoirs are often infected subclinically or asymptomatically and the distribution of the diseases basically reflects the range and the population dynamics of their reservoir hosts. As examples, emergence/re-emergence is discussed here for diseases caused by filoviruses, hantaviruses, paramyxoviruses, flaviviruses and Yersinia pestis. In addition, bioterrorism is addressed as one factor which has now to be considered in infectious disease emergence/re-emergence. Preparedness for known and unknown infectious diseases will be a top priority for our public health systems in the beginning of the millennium.