The Japan Association of Medical Technologists (JAMT) established a Disaster Response Headquarters in response to the “2024 Noto Peninsula Earthquake.” In cooperation with the prefectural clinical (hygiene) technologist associations, JAMT continuously dispatched clinical laboratory technologists for approximately three months. To minimize the risks associated with undergoing testing in the affected areas. The objective was also to provide reliable laboratory data for patients and support for the affected population. To ensure that the experiences from this incident contribute to future efforts, we examined the roles played by clinical laboratory technologists in medical relief activities during disasters and identified future challenges. To fulfill our role as a professional organization, we dispatched liaisons and coordinated and cooperated with related organizations and government agencies. Based on the course and results of these activities, several issues were identified as future challenges for JAMT, (1) Initial response system, (2) Provision of clinical testing reagents in the disaster area, (3) Dispatch of clinical laboratory technologists, (4) Securing accommodations for dispatched personnel, (5) Response by the prefectural clinical (hygiene) technologist associations, (6) Creation of implementation manuals and training for the institutionalization of newly implemented activities, (7) Effective distribution of limited medical resources. From the experience gained through these activities, we recognize that clinical laboratory technologists can play a wide variety of roles as a professional organization. To effectively distribute limited medical resources, it is essential for JAMT to develop disaster response policies that focus not on “what we can do and will do,” but rather on “what is needed and how it can be accomplished.”

Japanese Promotion Council for Laboratory Testing, in collaboration with multiple organizations involved in clinical laboratory testing, promptly and effectively conducted disaster support activities following the Noto Peninsula Earthquake as announced by the Japan Meteorological Agency on January 1, 2024. The purpose of this study is to clarify the role of these activities in disaster support and to examine the challenges faced. The support activities included liaison with the Ishikawa Prefectural Health, Medical, and Welfare Coordination Headquarters, which was established at the Ishikawa Prefectural Government Office, and providing simple testing equipment for basic health management and infection monitoring at evacuation centers. After confirming the interpretation of legal restrictions, they established a scheme that allowed for a swift response to requests for testing equipment and reagents from medical facilities. As a result of approximately two months of support activities, the risk of clinical testing in the disaster area was reduced, contributing to the provision of highly reliable test data. Additionally, the material supply scheme functioned effectively, allowing for a quick response to the needs of medical facilities and relief teams. On the other hand, challenges identified from the experience of these activities include: (1) Strengthening the cooperation system between organizations, (2) Optimizing the procurement and distribution scheme of supplies, (3) Developing disaster response manuals, (4) Enhancing cooperation with the local community, and (5) Preparing for legal restrictions in advance. By leveraging the experience and lessons learned, the aim is to enhance disaster response capabilities in the clinical testing field through improved preparedness and strengthened cooperation among stakeholders during normal times.

Purpose: In our country, which has become a super-aging society, the number of cases with concurrent cardiovascular diseases is increasing. Therefore, the importance of conducting comprehensive preoperative evaluations, including testing for patients suspected of having heart disease, is increasing. In our hospital, a unique department called the “Hospitalization and Discharge support Center” was established in 2015 with the aim of accurately assessing patient risks, ensuring smooth inpatient treatment, safer surgeries, and earlier discharge. From 2021, we have established a dedicated ultrasound reservation slot within the Hospitalization and Discharge Center. However, it remains unclear how many patients had specific findings detected during these cardiac ultrasound examinations and to what extent the detected findings have contributed to perioperative management. In this study, we retrospectively investigated the detection rate of significant findings in cardiac ultrasound examinations and their impact on perioperative management, considering the importance of constructing a preoperative evaluation system. Methods: We conducted a survey targeting 677 cases of cardiac ultrasound examinations requested from the dedicated reservation slot of the Hospitalization and Discharge support Center from April 2021 to March 2023. Results: No cases were found where scheduled surgical dates were postponed due to additional requests for preoperative cardiac ultrasound examinations. Significant findings were observed in 72% of all cases, and it was found that perioperative management, including the necessity of management, postponement, or cancellation, was implemented in each case. Conclusion: The results reaffirm the beneficial nature of preoperative cardiac ultrasound examinations for patients and clinical practice. We also report on the efforts of the Hospitalization and Discharge support Center, in conjunction with these examinations.

Aortic valve stenosis (AS) is a major valve disease in elderly; it is diagnosed using imaging techniques, such as transthoracic echocardiography. Although auscultation is the first diagnostic step in routine practice, it is auditory-dependent and difficult to quantify. Thus, research on cardiac sound analysis is in progress. This study was conducted to evaluate the possibility of determining AS severity using a phonocardiographic device (AMI-SSS01), including the experience of using the device. Twenty-one patients with AS and fifteen healthy participants were tested. There was a correlation between AS severity determined by transthoracic echocardiography and the maximum amplitude of the phonocardiogram obtained by AMI-SSS01 (r = 0.762). Maximum amplitudes were significantly different between the healthy participants and patients with mild AS group and moderate and severe AS group (p < 0.01). The sensitivity and specificity of AMI-SSS01 in detecting moderate or severe AS were 1.00 and 0.83, respectively. Furthermore, six users of the AMI-SSS01 were surveyed about the device’s usability, and it received average scores above 4 out of 5 for ease of use, clarity of operation, and portability. These findings suggest that the device is easy to use, straightforward to operate, and highly portable. Although further studies including other cardiac diseases and a larger number of cases are needed, this study suggests that AMI-SSS01 may be used to determine AS severity in a simple manner.

The present study examined the usefulness of the criterion “two or more mitotic figures per 40× objective field of view (2+ mitotic figures)” for the accurate diagnosis of HSIL. Cervical cytology was conducted on 30 cases of HSIL and 40 of ASC-H. Histological classifications were as follows: 24 cases of CIN2 or more (CIN2+), 4 of CIN1, and 2 of squamous metaplasia in the former group, and 24 cases of CIN2+, 4 of CIN1, and 12 of squamous metaplasia in the latter group. In Pap specimens, five HCG clusters were randomly selected and examined to assess the frequency of 2+ mitotic figures. Pap specimens were then destained and subjected to anti-phosphohistone H3 (PHH3) immunocytochemistry (ICC). As a result, in cases of CIN2+, the frequency of 2+ mitotic figures was significantly higher (p < 0.001) in ICC (42.8%) than in Pap (median: 0%). Regarding CIN2+ in ASC-H, ICC (40.2%) was significantly higher (p < 0.001) than Pap (0%). In comparisons of lesions in ASC-H by ICC, CIN2+ (40.2%) was significantly higher (p = 0.048) than squamous metaplasia (5.0%). 2) Regarding the frequency of 2+ mitotic figures in ASC-H, CIN2+ (95.8%) was significantly higher (p = 0.003) than squamous metaplasia (50%). 3) In addition, the time for detection of 2+ mitotic figures was significantly shorter (p < 0.001) by ICC (8.1 sec) than by Pap (52.9 sec). In conclusion, the detection of 2+ mitotic figures in PHH3-ICC is useful for the diagnosis of HSIL.

Data on the number of deaths by cause of death of soldiers in a field hospital and the circle chart “Bat’s Wing (B.W.)” recorded by Nightingale during the Crimean War were examined from the angle of statistics. Nightingale showed by B.W. that the number of soldiers dying from epidemics due to poor sanitation was far greater than the number dying from combat injuries. This study focused on the number of deaths due to infectious diseases and created a B.W. The number of patients dying from infectious diseases showed a significant positive correlation with the number of patients dying from injuries or from other causes. On the other hand, there was no significant relationship between the number of soldiers who died from infectious diseases and the number of troops. A multiple regression model with season as a dummy variable revealed that the number of deaths due to infectious diseases is strongly related not only to poor sanitation, but also to the season (summer). The area of the triangle for each month created by B.W. (B.W. area) was significantly correlated with the number of infectious disease deaths per month. The B.W. area seems to be a mathematical property of B.W. The B.W. area was also significantly correlated with the estimated number of deaths due to infectious diseases, calculated from the number of deaths due to injuries and the number of deaths due to other causes. This correlation was a pseudo-correlation with the number of infectious disease deaths as a confounding factor.

Objective: We examined the cell morphology in pleural effusion using low-vacuum scanning electron microscopy (LVSEM) to differentiate small cell carcinoma (SmCC) and lymphoma. Study Design: Our study included pleural fluid specimens from 16 cases, including seven cases of SmCC and nine cases of lymphoma. The specimens were examined and photographed under an optical microscope, and the cover glasses were removed using hot xylene. After conductive staining with phosphotungstic acid, the same specimens were observed, and photographs were obtained by LVSEM. Results: Differentiation between SmCC and lymphoma was impossible in five cases using an optical microscope alone. On LVSEM, SmCC cells showed “dome-like cell morphology” (85.7%), “high density microvilli” (85.7%), “cell binding positive” (85.7%), and “depression” (42.9%), while lymphoma cells showed a “spherical morphology” (100%), “short microvilli” (88.9%), and “cell binding negative” (88.9%). Differentiation was performed in 14 cases using LVSEM. Conclusion: Our findings suggest that using LVSEM in the cytopathological examination of pleural fluid is useful for distinguishing SmCC and lymphoma.

The single-breath carbon monoxide diffusing capacity of the lung is based on the washout volume (WV) of 750–1,000 mL and the sampling volume (SV) of 500–1,000 mL. According to the Practical Handbook Respiratory Function Testing of The Japanese Respiratory Society, WV can be reduced to about 500 mL in cases of low vital capacity or forced expiratory volume in one second. In this study, we compared the diffusing capacity of the lung for carbon monoxide (Dlco) in 21 healthy subjects between the standard method (WV 750 mL, SV 1,000 mL) and the WV reducing method in five conditions (only WV was reduced by 100 mL from 500 mL), examined the effects for the measured values and its validity of the methods. No significant differences in measured values were found between the standard method and the WV reducing methods up to 300 mL, and significantly lower values were found for the WV reducing methods below 200 mL. In addition, strong correlations were found between the standard method and the WV reducing methods up to 300 mL. From the above, Dlco could provide reliability results as a reference value in cases of WV reduced to 300 mL. These results suggested measurable cases may be expanded.

This study evaluated the basic performance of the Ampdirect^TM 2019-nCoV detection kit (Shimadzu Corporation), which does not require RNA purification and inter-measurer reproducibility of cycle thresholds. Within-run imprecision (repeatability) and within-laboratory imprecision (total precision) tests were performed on samples of EDX SARS-CoV-2 Standard (Bio-Rad Laboratories, Inc.) adjusted to two concentrations. The Coefficient of Variation (CV) of the cycle thresholds was stable at less than 2%. For the limit of detection test, samples of EDX SARS-CoV-2 Standard adjusted to 6 concentrations were measured. The limit of detection was 250 copies/mL for the N1 gene and 750 copies/mL for the N2 gene, which were sufficient for laboratory diagnosis of COVID-19. Comparison with the method according to the pathogen detection manual of the National Institute of Infectious Diseases using clinical samples measured from November 2022 to February 2023 showed an overall agreement rate of 96.3% (104/108 samples). Four discrepancy samples had low viral loads with cycle thresholds of 36 or higher. Inter-measurer reproducibility of cycle thresholds showed that the CV of cycle thresholds converged between 0.79% and 1.33%, respectively. However, significant differences in cycle thresholds between measurers were found by multiple comparison test (p < 0.05). This reagent has good basic performance and is expected to be widely used in clinical laboratories as a tool for laboratory diagnosis of SARS-CoV-2. On the other hand, it was necessary to consider inter- measurer reproducibility for quantitative evaluation of the cycle threshold.

Diabetes management has made great strides with the advent of safe and convenient diabetes medications. Continuous glucose monitoring is essential for effective glycemic control, and flash glucose monitoring systems (FGMS) such as the Freestyle Libre Pro^® (Libre Pro) provide minimally invasive and continuous monitoring capabilities. However, discrepancies in interstitial fluid glucose concentrations between anatomic sites, particularly in the bilateral upper arms, have not yet been fully investigated. The purpose of this study was to compare bilateral upper arm interstitial fluid glucose concentrations using Libre Pro. 14 days of bilateral arm interstitial fluid glucose concentrations were monitored in male subjects aged 20 to 30 years. Differences in bilateral upper arm glucose concentrations were analyzed. Significant differences in interstitial fluid glucose concentrations were observed between the bilateral upper arms, with the dominant arm having lower concentrations. Diurnal variations in glucose concentrations were observed, with lower concentrations at night than during the day. Differences in interstitial fluid glucose concentrations between the bilateral upper arms suggest the possibility of influencing monitoring accuracy and treatment decisions. These results emphasize the need for further research to optimize diabetes treatment strategies. The bilateral brachial differences in interstitial fluid glucose concentrations observed in this study emphasize the importance of anatomic considerations in glucose monitoring and diabetes management.

We evaluated a basic performance of the LT Auto wako RF (II) reagent (FUJIFILM Wako Pure Chemical Corporation Ltd.), which uses latex turbidimetry as the measurement principle and expands the measurement upper limit to 700 IU/mL. We obtained favorable results on accuracy, simultaneous reproducibility, and dilution linearity. The limit of detection was 0.6 IU/mL, which is equivalent to current reagents, and no influence of interfering substances was observed. The correlation with current reagents and reagents from other companies showed good correlation, r = 0.970 to 0.999. On the other hand, we observed cases in which the correlation decreased in cases where the values measured after dilution of samples exceeding the measurement upper limit were included. The concordance rate of each reagent with the reference value (15 IU/mL) was good at over 95%. The LT Auto wako RF improved reagent has sufficient performance for routine examinations, and because the upper limit of measurement has been expanded, it was thought that more expected to contribute to clinical diagnostics.

The SARS-CoV-2 antigen test is a cost-effective and rapid method for detecting COVID-19. However, certain testing kits carry a significant risk of false negatives, necessitating careful result interpretation. This study evaluates the performance of an SARS-CoV-2 detection kit that employs silver amplification immunochromatography (SAIC). Sixty-one nasopharyngeal swab specimens, submitted to the laboratory in our hospital for genetic testing, were analyzed using the Fujifilm Dry-Chem IMMUNO AG Cartridge COVID-19 Ag. Results were compared against those from real-time PCR (Xpert Xpress SARS-CoV-2) and chemiluminescent enzyme immunoassay (CLEIA) (HISCL SARS-CoV-2 Ag). The concordance rate between the SAIC method and PCR for nucleic acid detection was 75.4%, with a sensitivity of 70.6% and a specificity of 100.0%, showing results almost equivalent to the CLEIA method. Notably, all specimens with a PCR Ct value of 27 or below were consistently detected as positive by the SAIC method. Additionally, the SAIC method could detect specimens with a Ct value up to 28.9 when compared to diluted specimen sensitivity. The findings suggest that the SAIC method has a sensitivity comparable to the CLEIA method, indicating its potential for high-sensitivity SARS-CoV-2 detection. The advantages of the SAIC method are that it does not require water or consumables and the device is compact, making it suitable for routine point-of-care testing (POCT). Furthermore, it holds promise for use in disaster scenarios or in settings with limited infrastructure, providing an efficient screening tool under such conditions.

Patients with monoclonal immunoglobulin (M-protein) have an extremely high proportion of M-protein in their serum, significantly reducing the levels of other immunoglobulins. In contrast, non-M-protein patients have a more balanced distribution of various proteins. Proteins can either dissolve or precipitate when added to a salt solution, depending on the concentration. When patient serum was reacted with two solutions of different salt concentrations (purified water and phosphate-buffered saline), the absorbance changes were significantly different between M-protein and non-M-protein patients. Therefore, we investigated the optimal photometric wavelengths, volumes, and photometric points for M-protein screening based on these absorbance changes. The results showed that the optimal wavelength was 340 nm, the reagent volume was 80 μL, the patient serum volume was 16 μL, and the photometric point was 1. We subsequently evaluated the performance of this test method. For correlation, significant differences were observed in protein electrophoresis (presence or absence of an M-peak). For concomitant accuracy, the coefficient of variation (CV%) was 4.2% at an absorbance change of around 0.064. In terms of Randomized two-time measurement method, there was a strong correlation between the measurements of the two groups. For criterion validity, the cutoff value was set at 0.048 (sensitivity 67.7%, specificity 59.1%) based on the receiver operating characteristic (ROC) curve obtained from logistic regression analysis. The area under the curve was significantly higher with this test method than with the ROC curve for age, total protein levels, albumin levels, and A/G ratio alone. Therefore, this test is useful for M-protein screening.

Since the onset of COVID-19 pandemic in Japan, we launched both a quantitative antigen test and a real-time reverse transcription PCR test (RT-PCR) for SARS-CoV-2. We confirmed that the accuracy of the two tests was sufficient for clinical use. Initially, two nasopharyngeal swabs were collected separately for each test. Subsequently, we tried to perform these tests using a single nasopharyngeal swab to alleviate the stress on patients associated with sample collection. First, we extracted RNA from the remaining liquid sample for the antigen test and performed RT- PCR testing on 122 subjects. However, all results were negative, including 28 subjects positive for RT-PCR test using fresh nasopharyngeal swabs (nasopharyngeal RT-PCR test). We assumed that an unidentified PCR inhibitory factor contained in the sample treatment reagent caused the false negative results. Therefore, we extracted the viral RNA from the cotton swab used for the antigen test and ran the RT-PCR (used swab RT-PCR test). The results of the used swab and the nasopharyngeal RT-PCR tests were completely consistent on 228 samples. However, the Cp values in the used swab RT-PCR test (25.3 ± 4.2) were significantly higher than those in the nasopharyngeal RT-PCR test (22.9 ± 4.4) (t-test, p < 0.05). In addition, we performed identification of omicron variant BA.1 and BA.2 using both the nasopharyngeal and the used swab RT-PCR tests with melting curve analysis, and the results were completely consistent on 26 studied samples. In conclusion, the used swab RT-PCR test showed approximately equivalent assay performance to the nasopharyngeal RT-PCR test.

In recent years, the number of complicated cases of chronic pulmonary aspergillosis (CPA), which develops on a background of pulmonary non-tuberculous mycobacteriosis (NTM), has increased. In this study, we examined Aspergillus spp. isolated at our hospital during the 5-year period from 2012 to 2016, the species identified by a simple identification method, and their antifungal susceptibility. A. fumigatus was the most common isolate with 102 (44.9%), followed by A. niger 66 (29.0%), A. flavus 21 (9.3%), Aspergillus (unidentified) 21 (9.3%), A. terreus 13 (5.8%) and A. nidulans 4 (1.8%). Most of the patients from whom A. fumigatus was isolated were elderly men in their 70s, and the NTM isolated at the same time was Mycobacterium avium. On the other hand, patients with A. niger isolates tended to be both males and females in their 70s and older, and M. avium and M. intracellulare were more common. Looking at these by disease, many patients were found to have isolated Aspergillus spp. against the background of pulmonary NTM disease. Most of the isolates showed good antifungal susceptibility, but we experienced one case of A. fumigatus that became resistant to ITCZ and VRCZ from a patient who developed CPA after treatment for pulmonary NTM disease. Its main resistance mechanism was a mutation of genotype M220 in the cyp51A gene. In cases of long-term use of azole antifungal drug, periodic susceptibility testing was considered necessary in consideration of the emergence of resistant strains.

A woman in her 60s presented with the chief complaints of fever and right hypochondriac pain. Ultrasonography (US) showed an enlarged gallbladder and circumferential wall thickening with laminar structures, and CT showed circumferential wall thickening with dilatation of the Rokitansky-Ashoff sinus. She was diagnosed with xanthogranulomatous cholecystitis (XGC). The patient’s condition was relieved with antibiotic treatment. However, 27 days after onset, US showed a progression of the gallbladder wall. The wall was irregular with a loss of layering, but the innermost hyperechoic layer (IHL) was continuous. The wall was hyperechogenic with a hypoechoic area inside the wall. CT showed inflammation spreading to the hepatic be. We therefore suspected an exacerbation of XGC, but advanced gallbladder cancer was also suspected. The diagnosis of XGC was further confirmed by the finding of hypoechoic areas inside the wall and continuity of IHL, as well as an improvement in gallbladder wall thickening. Laparoscopic cholecystectomy was performed 98 days after onset, and the pathological diagnosis was XGC. The course of US findings suggested that the patient was in the transition stage from acute cholecystitis to XGC when he first visited our hospital, and that xanthogranuloma had formed on day 27 of onset. When observing the course of XGC with US, differentiate it from gallbladder cancer by focusing on changes in the gallbladder wall structure and continuity of IHL, and also it is necessary to carefully observe the entire gallbladder, keeping in mind the possibility that gallbladder cancer may exist in areas other than XGC.

After several preliminary examinations, the Chiba Prefecture Clinical Laboratory Technologist Association conducted an external quality assessment of SARS-CoV-2 nucleic acid amplification testing using 2023 commercially available reagents. Distilled water was preferred for sample dilution over the virus transport media, and the distribution concentration was adjusted to match the final reaction system concentration with each device’s dilution process. Of the 62 facilities and 62 devices evaluated across 14 models, positive samples were confirmed, excluding one model suspected to be affected by settings near the detection limit concentration. However, three facilities falsely identified negative samples as positive. Member facilities want to implement external quality assessments, and this quality control assessment using commercially available reagents is considered a stable and sustainable operation.

Currently, there have been many reports that activating incident and accident reporting activities are important initiative for improving medical safety in clinical scene. However, there are few reports on the number of incidents and accidents that occur in association with the work of clinical laboratory technicians in Japan and overseas. Therefore, we conducted a questionnaire survey on the incident and accident reporting activities at 76 nationwide Saiseikai medical facilities that have clinical laboratories, as well as facilitating activities to increase reporting and the action process against the incidents/accidents. We received responses from 71 (93%) out of 76 facilities. The maximum total number of near misses/incidents/accidents reported was 536, and the minimum was 0. The maximum number of cases reported per technician was 32.3. Many activities were made to increase the number of reports, including promotional activities of reporting, sharing report content, establishing a system for easy reporting, and setting targets for the number of reports. The most common action process against the incident/accident report were: alerting related department staff, changing procedures/work manuals, improving the work environment related to the incident, alerting those who carried out the incident, and revision of educational instruction related to the incident. A positive correlation was found between the number of incident reports and the number of near misses. Although there was no relationship between activities to increase the number of reports and the number of reports, association was found between the number of incident report and the number of actions against incident report. It was thought that improvement actions against incident report had a positive impact on clinical practice and led to an increase in the number of incident reports.

In contrast to progress in standardization in the field of clinical testing, standardization in clinical microbiological testing is gradual and inadequate because testing techniques and results are highly dependent on technicians’ skill and judgment. Prior to the microbiology section symposium sponsored by the Kinki branch of the Japanese Association of Medical Technologists, we performed a questionnaire survey that targeted microbiological testing facilities in the Kinki area. We surveyed the current status of testing, including the pretest process, smear testing, bacterial species identification, antimicrobial susceptibility testing, tests to confirm bacterial resistance, blood cultures, and comments regarding result reporting. The results revealed that the current situation differs significantly depending on the facility, including the testing methods and methods of reporting comments on results. This survey may be useful to gain deeper insight into the current situation and to promote future standardization.

Since 2016, our hospital’s laboratory has been operating using a combination of the successful “Toyota Method” as a management strategy and the “Lanchester Strategy,” which is a management strategy for small and medium-sized enterprises. Leveraging the strengths of our municipal hospital, we achieved a revenue-to-expense ratio of 61.9% and a breakeven point ratio of 21.7% (the highest) in 2018. Although there was a temporary decline due to the COVID-19 pandemic, we are currently in a gradual recovery phase. We examined whether we could achieve a continuously evolving laboratory that responds to the needs of the clinical field by focusing on three points: thorough elimination of waste, talent development using the 5S method, and differentiation in the operation of the specimen laboratory to improve revenue and meet clinical needs.

Cases of falsely low IgG levels due to the prozone phenomenon have been reported due to the discrepancy between globulin levels and the total of immunoglobulins. In IgG assay reagents, there are polyclonal antibodies that react with the subclasses from anti-IgG1 to anti-IgG4, the prozone concentrations are different for each subclass. In this case, although the immunoglobulins measured within the quantitative range of the reagent, the increase in IgG1 caused the prozone phenomenon, resulting in a false low value. To detect such cases, a method using the measured values of TP, Alb and immunoglobulins was studied. As a measure of response, a histogram of globulin and total Ig values was created to determine large differences, which was identified as +3 SD of 2.1 g/dL. Furthermore, to detect the prozone more efficiently, a reference upper limit value of 8.1 g/dL for the TP has been used. Based on the above results, a check function can be set up in the laboratory information system (LIS) for samples with a difference of more than 2.1 g/dL between globulin and total Ig and TP of more than 8.1 g/dL. To avoid missing subclass prozone phenomena, the LIS could be used.

Acquired factor V inhibitor (AFVI) is an autoantibody against factor V (FV). AFVI is a relatively rare autoimmune disease among acquired coagulation factor inhibitors and there have been limited case reports of AFVI, thus the laboratory characteristics of AFVI had been shown in some variation. In this study, we investigated four cases of AFVI in order to understand the characteristics of laboratory findings in AFVI. We compared the laboratory test characteristics with cases of vitamin K deficiency (VKD) and congenital FV deficiency (CFVD), both of which present with prolonged PT and APTT. As a result, the APTT in patients with AFVI or CFVD was more prolonged against the prolongation of PT compared to VKD. This would be due to the different sensitivity of the reagents to FV activity. On the other hand, AFVI and CFVD did not differ significantly from each other in the degree of prolongation of APTT relative to PT, but AFVI showed an inhibitor pattern in the PT- and APTT-mixing test, which could be distinguished from CFVD, which showed a coagulation factor deficient pattern. These results suggested that AFVI could be distinguished from CFVD using PT- and APTT-mixing tests. All patients with AFVI enrolled in the current study would carry a neutralizing antibody against FV, thus we could not investigated patients with clearance antibody against FV. This was a limitation of this study. However, the characteristics of AFVI could be evaluated by comparing the degree of PT and APTT prolongation according to the coagulation factor sensitivity of the assay reagents, and by considering the results of the mixing test. The certain predictions can be made before obtaining the results of FV activity or FV inhibitor titer, and it might be possible to distinguish AFVI from VKD and CFVD in combination routine laboratory tests with mixing test.

Since 2012, a healthcare reimbursement fee has been available for infection prevention and control in Japan, and infection control networks have been established in each area. This study reports on opinions, improvements, and evaluations emerging from a consultation with facilities that have introduced outsourced microbiological testing without an infectious disease specialist. Doctors, nurses, and clinical laboratory technicians from Kyushu University initiated a consultation on outsourced microbiological testing at Sakurajyuji Fukuoka Hospital, a general hospital with 199 beds. The consultation started during the COVID-19 pandemic, and information was collected and opinions exchanged via email and online meetings. A review of the operation of outsourced microbiological test items was then proposed and the effectiveness of this was evaluated. The review highlighted the need for education and familiarization to ensure that tests are carried out on the patients who need them, and that the set of tests selected is optimal. This led to improvements and cost savings, and awareness was also raised among those involved in the consultation through this initiative. When facilities receiving the reimbursement for infection prevention and control and infectious disease specialists were working together on the consultation, it was important to understand each other’s position and take time to communicate with each other.

CAR-T cell therapy is an immunotherapy in which T cells with chimeric antigen receptors transfected into them attack the patient’s tumor cells. Our hospital became a certified facility for tisagenlecleucel in February 2020, and clinical laboratory technicians in the transfusion and cell therapy room provide comprehensive support for everything from leukapheresis to cell counting, cell preparation, and storage management. Doctors secure veins for leukapheresis, connect and disconnect the centrifugal blood component separator to the patient, and remove the needle and stop bleeding. When one volume of circulating blood is processed, the number of nucleated cells and CD3+ T cells in the collection bag are measured, and the timing of completion is discussed with the doctor. Cell preparation is performed in the cell culture and processing facility, and the program freezer and gas-phase liquid nitrogen tank for freezing are efficiently operated adjacent to the cell culture and processing facility. There were 64 leukocyte apheresis procedures performed between April 2020 and October 2023, and there were no cases of readjustment of the leukocyte apheresis date or serious adverse events during collection. It is important to perform CAR-T cell therapy at the appropriate time, taking into account the treatment schedule of patients who are eligible for CAR-T cell therapy. By having clinical laboratory technicians in the transfusion and cell therapy room provide comprehensive support from leukocyte apheresis to storage, there is no need to coordinate work with other departments, and flexible responses can be made to each patient.

In the medical field in Japan, shortening the working hours of doctors has become an important issue, and restrictions on overtime work and holiday working hours for doctors were established from April of Reiwa 6. Each medical facility needs to formulate a plan to shorten working hours, and one way to do this is to shift or share tasks to medical laboratory technicians. The Japan Association of Clinical Laboratory Technologists conducts a fact-finding survey to understand the current situation of clinical laboratory technicians and publishes the results. In this study, we analyzed the results and examined the impact of task shifting/sharing from physicians to clinical laboratory technicians on the occurrence of accidents. As a result, it was found that the incidence of accidents tended to be higher in facilities with inadequate education and training, but the occurrence of accidents was suppressed in facilities with appropriate education, training, and management systems. In conclusion, task shifting/sharing to medical technologists can be safely implemented under appropriate education, training and management systems. This is expected to encourage doctors and other healthcare professionals to work together to provide quality healthcare services and create a sustainable working environment.

Japan’s healthcare system has achieved a high level of health care through universal health insurance. On the other hand, although there is a possibility that the increase in total medical expenses will slow due to the population decline after 2040, it is inevitable that medical expenses will increase for some time due to the increase in the elderly population. For this reason, medical cost optimization plans have been formulated, and each prefecture is required to make efficient use of medical resources. This study aims to identify priority items for policy intervention by examining regional differences in the allocation of medical resources in clinical testing. Using 2021 NDB open data, we analyzed the calculation frequency of “D tests” and selected items with significant regional disparities based on the population of each prefecture. Additionally, we conducted interviews with the Japan Association of Medical Technologists. The results identified ultrasound examinations in home visits and anorectal function tests as medical services with potential for policy intervention. Factors contributing to regional differences included: (1) areas where securing human resources is challenging, (2) regional disparities in the availability of physicians capable of performing tests, and (3) the progress of the spread of newly added items in medical fee revisions. In conclusion, further analysis and optimization are needed for ultrasound examinations in home visits and anorectal function tests. This study underscores the importance of policy intervention to address regional differences in medical resource allocation and contributes to future plans for optimizing medical expenses.

This study aimed to investigate Japanese medical technologists’ perceptions of AI in laboratory medicine and evaluate the significance of seminars on emerging technologies. An online survey was conducted before and after a seminar titled “Artificial Intelligence and Clinical Laboratory: A Tale of the Encounter between Deep Tech and Medical Technicians” held on August 19, 2023. Responses were analyzed using Fisher’s exact test, and free-text responses were analyzed using a co-occurrence network. Of the 278 pre-seminar respondents, 62.9% had positive attitudes towards AI. The AI-positive group showed significantly higher usage of AI-related web services (p < 0.01) and more proactive information-seeking behavior (p < 0.05) compared to the non-positive group. Post-seminar, support for “AI results must always be verified by medical technologists” significantly decreased (p < 0.05). Additionally, 63.9% of the 169 participants expressed intent to actively gather information in the future. Free-text responses revealed expectations for work improvement, quality enhancement, and technological advancement, alongside concerns about AI implementation. The results suggest that while many respondents view AI positively, their expectations are predicated on maintaining traditional roles. The seminar appeared to catalyze information-seeking behavior. This study revealed Japanese medical technologists’ positive perceptions of AI and concluded that seminars including explanations of emerging technologies and discussions are valuable. These findings may contribute to discussions on AI implementation in laboratory medicine and the design of continuing education programs for medical technologists.

Activated partial thromboplastin time (APTT) is a test to screen for endogenous and common coagulation factors, although a prolonged APTT is suspected to indicate decreased endogenous and common coagulation factors and the presence of antiphospholipid antibodies. However, centrifugal conditions, anticoagulant medications, heparin contamination, and other factors can affect the measurement results. In order to differentiate between these factors, it is necessary to collect medical history and medication information, and to exclude the influence of heparin in the evaluation. Protamine-supplemented APTT (PS-APTT) is useful for differentiation, but because heparin sensitivity differs among reagents, it is necessary to set the optimal concentration of protamine to be added for each reagent. We investigated the concentration of protamine added to Revohem APTT SLA in unfractionated heparin administered or contaminated specimens with APTT > 34.0 seconds, and found that 123 of 207 (59.4%) had a shortened PS-APTT. In addition, heparin contamination could be distinguished by adding 0.1 mg/mL of protamine sulfate solution to specimens with an APTT of less than 75 seconds and 0.2 mg/mL of protamine sulfate solution to specimens with an APTT of 75 seconds or longer. The PS-APTT could be easily reported except for specimens exceeding the upper limit of the APTT measurement, and it is thought to be possible to report useful results to the clinic by quickly identifying heparin contamination in cases of prolonged APTT.

As the number of emergency patients increases nationwide, and the burden on doctors and nurses grows, task shifting/sharing to various professions is being promoted to ensure the sustainability of healthcare. In 2021, the scope of clinical laboratory technicians’ work was expanded, and their role in emergency settings became more expected. To achieve this, our hospital’s lab department has been working on streamlining and standardizing tasks since 2018 to improve workforce efficiency. After establishing a new group and training generalists, we began full-scale implementation with a permanent system in 2023. By handling newly expanded tasks due to legal reforms, as well as traditional tasks such as blood draws, ECGs, and specimen collection, we reduced the burden by approximately 1,005 hours annually. However, legal restrictions limit effective burden reduction in areas such as IV access and transfusion therapy. We believe that having clinical laboratory technicians permanently stationed in emergency departments improves workforce efficiency and deepens collaboration with other professions, contributing to the enhancement of emergency medical care quality.

We analyzed the occurrence of discomfort during blood collection in our central blood collection room using approximately 700,000 blood sampling records. A total of 111 cases developed symptoms of discomfort. The incidence rate was 0.02%, with 59% of the cases occurring in individuals under the age of 30. The incidence rate varied by season, with the lowest being 0.005% in April and the highest being 0.028% in July. The incidence rate increased with the number of blood collection tubes; however, when comparing the same number of tubes, there was no significant difference in the blood volume with and without symptoms. The blood collection time was longer compared to cases without symptoms. No correlation was found between the occurrence of symptoms and the skill level or gender of the staff. The occurrence of discomfort during blood collection in our central blood collection room has been presented. Despite the differences in the patient demographics in blood donation rooms, health examination facilities, and hospital blood collection rooms, there is a consistent trend where younger individuals are more prone to experiencing these symptoms. In hospital blood collection rooms, healthcare providers can focus on factors such as patient age, season, and the number of blood collection tubes to proactively prevent the onset of discomfort or detect it early if it occurs.

Introduction: At our hospital, we prepare and store dithiothreitol (DTT)-treated irregular antibody screening (SC) blood cells for each lot change as confirmation of false-positive reactions to anti-CD38 antibody drug administration for irregular antibody testing. DTT-treated erythrocytes are useful to confirm the chemical properties of irregular antibodies. Here, we describe two cases in which anti-Landsteiner–Wiener (LW) was suspected in an irregular antibody test, and DTT-treated SC erythrocytes were useful for confirmation. Case 1 is a woman in her 70s who is positive for type B RhD and negative for SC. After 1 month, two red blood cell transfusion units were requested because of low Hb levels. Irregular antibody SC was positive, and the identification test showed an anti-D-like reaction. The irregular antibody SC test with DTT-treated SC erythrocytes was negative and anti-LW. Six red blood cell units were transfused and no adverse reactions occurred. Case 2 is a woman in her 90s with myelodysplastic syndrome who is positive for RhDO and irregular antibodies. The identification test showed an anti-D-like reaction, which was negative in the irregular antibody test with DTT-treated SC erythrocytes, and was anti-LW. Sixteen red blood cell units were transfused and no adverse reactions occurred. Discussion: Anti-LW is not a clinically significant antibody but has cross-match incompatibility. Moreover, RhD-negative erythrocytes with less LW antigen should be used because reactive confirmation by DTT-treated erythrocytes is important for differentiating anti-LW from anti-D-like autoantibodies. DTT-treated erythrocytes used to confirm false-positive reactions to anti-CD38 antibody drugs were useful for detecting anti-LW.