Clinical Laboratory Technologists Research Articles

Benefit analysis of the auto-verification system of intelligent inspection for microorganisms.

In recent years, the automatic machine for microbial identification and antibiotic susceptibility tests has been introduced into the microbiology laboratory of our hospital, but there are still many steps that need manual operation. The purpose of this study was to establish an auto-verification system for bacterial naming to improve the turnaround time (TAT) and reduce the burden on clinical laboratory technologists. After the basic interpretation of the gram staining results of microorganisms, the appearance of strain growth, etc., the 9 rules were formulated by the laboratory technologists specialized in microbiology for auto-verification of bacterial naming. The results showed that among 70,044 reports, the average pass rate of auto-verification was 68.2%, and the reason for the failure of auto-verification was further evaluated. It was found that the main causes reason the inconsistency between identification results and strain appearance rationality, the normal flora in the respiratory tract and urine that was identified, the identification limitation of the mass spectrometer, and so on. The average TAT for the preliminary report of bacterial naming was 35.2 h before, which was reduced to 31.9 h after auto-verification. In summary, after auto-verification, the laboratory could replace nearly 2/3 of manual verification and issuance of reports, reducing the daily workload of medical laboratory technologists by about 2 h. Moreover, the TAT on the preliminary identification report was reduced by 3.3 h on average, which could provide treatment evidence for clinicians in advance.

New Role and Implications of Japanese Clinical Laboratory Technologists through Team Medical Care

New Role and Implications of Japanese Clinical Laboratory Technologists through Team Medical Care

New Role and Implications of Japanese Clinical Laboratory Technologists through Team Medical Care

New Role and Implications of Japanese Clinical Laboratory Technologists through Team Medical Care

Proposals on Basic Data Based on Comparison of Changes in Clinical Laboratory Technologists’ National Examination and Job Definition: Focused on Korea, Japan, and Taiwan

Proposals on Basic Data Based on Comparison of Changes in Clinical Laboratory Technologists’ National Examination and Job Definition: Focused on Korea, Japan, and Taiwan

Artificial Intelligence for Kidney Stone Spectra Analysis: Using Artificial Intelligence Algorithms for Quality Assurance in the Clinical Laboratory

ObjectiveTo determine if a set of artificial intelligence (AI) algorithms could be leveraged to interpret Fourier transform infrared spectroscopy (FTIR) spectra and detect potentially erroneous stone composition results reported in the laboratory information system by the clinical laboratory. BackgroundNephrolithiasis (kidney stones) is highly prevalent, causes significant pain, and costs billions of dollars annually to treat and prevent. Currently, FTIR is considered the reference method for clinical kidney stone constituent analysis. This process, however, involves human interpretation of spectra by a qualified technologist and is susceptible to human error. MethodsThis prospective validation study was conducted from October 29, 2020, to October 28, 2021, to test if the addition of AI algorithm overreads to FTIR spectra could improve the detection rate of technologist-misclassified FTIR spectra. The preceding year was used as a control period. Disagreement between the AI overread and technician interpretation was resolved by an independent human interpretation. The rate of verified human misclassifications that resulted in revised reported results was the primary end point. ResultsSpectra of 81,517 kidney stones were reviewed over the course of 1 year. The overall clinical concordance between the technologist and algorithm was 90.0% (73,388/81,517). The report revision rate during the AI implementation period was nearly 8 times higher than that during the control period (relative risk, 7.9; 95% CI, 4.1–15.2). ConclusionThis study demonstrated that an AI quality assurance check of human spectra interpretation resulted in the identification of a significant increase in erroneously classified spectra by clinical laboratory technologists.

The Role of Perfusionists during the COVID-19 Pandemic and Clinical Laboratory Technologists: Comparison of Training Systems in Japan and the United States

The Role of Perfusionists during the COVID-19 Pandemic and Clinical Laboratory Technologists: Comparison of Training Systems in Japan and the United States

Virtual assessment, training, and evaluation of clinical laboratory technologists amidst peak Covid-19 pandemic: An observational study.

Medical technologists are considered a neglected group when it comes to academic interventions. We developed and implemented an educational intervention and assessment for the technologists based on an online questionnaire as a pre-test consisting of questions related to knowledge (n=5), attitude (n=3), and practices (n=4) of daily internal quality control (QC) monitoring via Google Docs survey tool. This study served multiple purposes. It allowed keeping the technologists engaged during the peak of the COVID-19 pandemic while also improving the knowledge, attitude, and practices about the internal quality control using Bio-Rad Unity Real Time (URT) QC software. Subjects were graded based on the scores they received out of 100 (0-60 = poor; 61-79 = good; 80-100 = excellent). Training materials, i.e., a set of 5 videos every week via e-mail, were circulated. A voice-over PowerPoint presentation was also shared for easy comprehension. This activity was repeated after one month. A post-test was administered to assess the improvement. The study results show significant improvement in the technologists' performance after the intervention.

Uniform management and primary readings of capsule endoscopy by clinical laboratory technologists aimed towards task shifting and sharing

Uniform management and primary readings of capsule endoscopy by clinical laboratory technologists aimed towards task shifting and sharing

Examination of Conditions for External Quality Control in Identification of Microorganisms using Matrix-Assisted Laser Desorption/Ionization Time-of-Flight Mass Spectrometry.

Matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS) was approved for medical use in 2011 and is currently used as a rapid, accurate and lowcost technique for bacterial identification. External quality control for medical analysis is monitored using tests of the Japanese Association of Medical Technologists and Prefectural Association of Clinical Laboratory Technologists and through user surveys of reagent and equipment manufacturers. However, external quality control of bacterial typing using MS is not performed. Therefore, we examined procedures for evaluating quality control of bacterial typing using an identification reliability index at 38 facilities.

Accommodating clinical trials and other externally manufactured cellular therapy products: challenges, lessons learned and creative solutions

Background aimsThe Division of Transfusion Medicine and Cellular Therapy at New York-Presbyterian/Columbia University Irving Medical Center (NYPH-CUIMC) comprises the immunohematology laboratory and blood bank (transfusion service), hemotherapy/apheresis and the cellular therapy laboratory (CTL). The CTL processes and stores hematopoietic progenitor cells for bone marrow transplantation from all currently acceptable sources, including bone marrow, peripheral blood and umbilical cord blood. The laboratory provides services for the pediatric and adult blood and marrow transplant programs at both NYPH-CUIMC and the Morgan Stanley Children's Hospital of New York-Presbyterian. The laboratory processes and stores approximately 200 cellular therapy products per year, and the division participates in numerous clinical trials within the institution and with external pharmaceutical manufacturing facilities. As a licensed tissue bank, commercial chimeric antigen receptor T-cell products and other cellular-based therapies that are approved by the US Food and Drug Administration (FDA) are routed through the CTL for storage, processing, coordination of transportation, chain of custody and, eventually, thaw and distribution. Currently, we are distributing four such products from Kite Pharma, Novartis and Bristol Meyers Squid. In comparison to the amount of work, we employ a small staff of only four full-time clinical laboratory technologists, one technical specialist, one quality and operations manager and one medical director. In recent years, the growing use of the hematology/oncology service and the introduction of new immunotherapies have put significant pressure on our division to accommodate and scale up operations. Accompanying this growth is a mounting administrative burden and upsurge in regulatory and protocol-specific oversight. The purpose of this article is to share lessons learned and creative solutions to help better accommodate the surge in development of novel cellular therapies. MethodsTo handle this increase in demand, the CTL worked to standardize administrative procedures, implement comprehensive document control solutions, digitize data collection and implement lean design concepts to increase effectiveness and mitigate risk. ResultsDistribution of a standard operating procedure for clinical trial management improved the “on-boarding” process and allowed the laboratory to have more influence in the decision-making process. Implementation of digital workflows and a comprehensive document control system allowed for improved organization of critical documents and proved to be flexible enough to accommodate various protocol-specific requirements. Introduction of visual ques and reorganization of the workspace facilitated better organization, mitigated risk and assisted the laboratory in maintaining regulatory compliance. ConclusionsBetter-defined, structured and controlled laboratory processes helped laboratory management implement new clinical trials and track critical data. Implementing digital solutions using widely available tools like Microsoft SharePoint has proven to be a very secure, low-cost and flexible solution to keeping us “up-to-date” and inspection-ready.

How a manager’s behavior affects job satisfaction among clinical laboratory technologists in a team

How a manager’s behavior affects job satisfaction among clinical laboratory technologists in a team

Changes in Self-Care Behavior (Summary of Diabetes Self-Care Activities Measure) Using Real-Time Blood Glucose Monitoring with the Free Style Libre

No studies have reported changes in self-care behavior, and it remains unclear whether Free Style Libre (Libre) differs from conventional blood glucose self-monitoring devices in this regard. Therefore, we instructed diabetes patients using conventional self-monitoring blood glucose (SMBG) devices to use the Libre and prospectively examined the effect of this new device on self-care behavior and patient treatment satisfaction. The subjects comprised 41 outpatients with diabetes who were using conventional SMBG devices. The subjects were randomly assigned to group A, which comprised patients using Libre for ≥2 weeks (n = 21), or group B, which comprised patients who continued using conventional SMBG devices (n = 20). All patients received 30 minutes of diet and exercise therapy instruction from a registered dietitian and nurse (or clinical laboratory technologists). The Summary of Diabetes Self-Care Activities measure (SDSCA) was administered at baseline, 1, 3, and 6 months. Changes in the SDSCA, glycated hemoglobin (HbA1c), glycated albumin (GA), and body weight from baseline to 1 month were analyzed (UMIN000029016). At baseline, the two groups did not differ significantly in terms of the HbA1c, GA, body weight, or 17 SDSCA items. At 1 month, the numbers of days involving eating five or more servings of fruits and vegetables were 5.0 (3.3, 6.8) in group A and 3.0 (1.0, 6.0) in group B, the numbers of days involving exercise for at least 30 minutes were 5.0 (2.0, 6.0) in group A and 2.0 (0, 3.0) in group B, and the number of days involving specific exercise were 3.0 (2.0, 6.0) in group A and 1.5 (0, 2.3) in group B; both of these values were significantly higher in group A than in group B (p = 0.033, 0.037 and 0.041, respectively). These results suggest that the use of the Libre may improve the self-care behaviors of diabetes patients regarding diet and exercise, compared with the use of conventional SMBG devices. Disclosure A. Kudara: None. T. Tosaki: Other Relationship; Self; Eli Lilly and Company, Takeda Development Center Asia, Pte. Ltd., MSD K.K., Mitsubishi Tanabe Pharma Corporation. S. Sato: None. A. Inagaki: None. M. Kondo: None. S. Tsunekawa: None. Y. Kato: Speaker's Bureau; Self; Merck Sharp & Dohme Corp., Sanofi, Takeda Pharmaceutical Company, Eli Lilly Japan. H. Kamiya: Other Relationship; Self; MSD K.K., Ono Pharmaceutical Co., Ltd., Sanofi K.K., AstraZeneca, Astellas Pharma KK, Eli Lilly and Company, Novartis Pharma K.K., Dainippon Sumitomo Pharma Co., Ltd, Boehringer Ingelheim Pharmaceuticals, Inc., Takeda Pharmaceutical Co., Ltd, Ono Pharmaceutical Co., Ltd. J. Nakamura: Other Relationship; Self; Astellas Pharma US, Inc., AstraZeneca, Ono Pharmaceutical Co., Ltd., MSD K.K., Kyowa Hakko Kirin Co., Ltd., Kowa Pharmaceuticals America, Inc., Sanofi K.K., Taisho Pharmaceutical Co., Ltd., Takeda Development Center Asia, Pte. Ltd., Mitsubishi Tanabe Pharma Corporation, Eli Lilly and Company, Novartis Pharma K.K., Pfizer Inc..

The Roles and Recommendations of Clinical Laboratory Technologists as Multi-disciplinary Collaborators in Health Evaluation and Promotion

The Roles and Recommendations of Clinical Laboratory Technologists as Multi-disciplinary Collaborators in Health Evaluation and Promotion

423P A targeted cancer clinical sequencing system based on a clinical biobank in Hokkaido University Hospital

Background Development of genomic medicine enables us to perform contemporary clinical sequencing, while the acquision of high quality biospecimen and the appropriate handling of these materials are indispensable. In Hokkaido University, we have started Clinical Biobank, a novel system for On-Demand type banking in 2014. We obtain biospecimens including blood and tissue fixed by PAXgene Tissue system, and extract DNA and RNA from PAX-fixed paraffin embedded sample with the high quality and enough amounts for clinical sequencing after the pathological evaluation. Using this clinical biobank workflow, we have established the Division of Clinical Cancer Genomics for cancer personalized medicine, and started cancer clinical sequencing as a clinical examination. Methods We developed a novel cancer clinical sequencing system by amplicon exome sequence targeting 160 cancer genes; CLHURC (Clinical Sequence System in Hokkaido University Hospital for Cancer Individualized Medicine) collaborating with Mitsubishi Space Software Co. Ltd (MSS). In our system, genomic DNA was extracted from both tumor tissue and peripheral blood mononuclear cells as a normal control, and perform deep sequencing using MiSeq. FastQ files were analyzed by MSS using original bioinformatics pipeline within 3 business days, and we identified cancer-specific somatic gene alteration such as SNV, Ins/Del and CNV. Finally, cancer board conference consisting of medical oncologists, pathologists, clinical laboratory technologists, bioinformaticians and clinical geneticists proposes the personalized treatment strategies based on the gene profiles. Results During 4 months, we examined 43 cancer patients and perform targeted exome sequence. As a result, detection rate of actionable gene mutation and druggable gene mutation was around 86% and 44%, respectively. Conclusions We believe that our novel clinical sequencing system using biospecimen based on Clinical Biobank will vigorously promote cancer individualized medicine throughout Japan and also Asia. Legal entity responsible for the study N/A Funding Hokkaido University Disclosure All authors have declared no conflicts of interest.

Breast Cancer Risk after Occupational Solvent Exposure: the Influence of Timing and Setting

Organic solvents are ubiquitous in occupational settings where they may contribute to risks for carcinogenesis. However, there is limited information on organic solvents as human breast carcinogens. We examined the relationship between occupational exposure to solvents and breast cancer in a prospective study of 47,661 women with an occupational history in the Sister Study cohort. Occupational solvent exposure was categorized using self-reported job-specific solvent use collected at baseline. Multivariable Cox regression analyses were used to assess breast cancer risk, adjusting for established breast cancer risk factors. A total of 1,798 women were diagnosed with breast cancer during follow-up, including 1,255 invasive cases. Overall the risk of invasive breast cancer was not associated with lifetime exposure to solvents [HR, 1.04; 95% confidence interval (CI), 0.88-1.24]. Parous women who worked with solvents before their first full-term birth had an increased risk of estrogen receptor-positive invasive breast cancer compared with women who never worked with solvents (HR, 1.39; 95% CI, 1.03-1.86). A significantly elevated risk for estrogen receptor-positive invasive breast cancer was associated with solvent exposure among clinical laboratory technologists and technicians (HR, 2.00; 95% CI, 1.07-3.73). Occupational exposure to solvents before first birth, a critical period of breast tissue differentiation, may result in increased vulnerability for breast cancer. Our findings suggest a need for future studies in this area to focus on exposure time windows and solvent types in different occupational settings.

Detection of anti-IgA antibodies using the particle gel immunoassay: a rapid test for increased patient safety.

Patient safety is a major issue in transfusion medicine and commands continuous efforts to develop valid control methods aiming to avoid serious transfusion-related complications. Anti-IgA antibodies can cause anaphylactic transfusion reactions in IgA-deficient individuals. Since standard quantitative methods for anti-IgA measurement require considerable time to be performed, in an emergency situation it can be a challenge to prevent or to quickly interpret and manage acute transfusion reactions suspected to be a consequence of anti-IgA. The purpose of this study was to test and validate at our transfusion centre a rapid assay for the identification of patients with anti-IgA antibodies. Forty-six samples (6 from healthy controls and 40 from IgA-deficient patients) were collected. Sera were analysed blindly by three different clinical laboratory technologists using two DiaMed particle gel immunoassays (ID-PaGIA) for IgA deficiency and for antibodies to IgA. The results were subsequently checked with the results of a fluorescence enzyme immunoassay conducted in the reference immunology laboratory. The ID-PaGIA had a sensitivity of 91.7% and specificity of 97.1% for the IgA deficiency test. With regards to the detection of anti-IgA antibodies, the sensitivity was 89.3% and the specificity 100%. The reproducibility of the test was 100%. The ID-PaGIA screening assays are suitable for the investigation of transfusion-related anaphylactic reactions in a routine blood bank laboratory. Although the gel card technique does not quantify the level of anti-IgA antibodies, it is readily available, providing an effective and simple method for the diagnosis of anti-IgA related anaphylaxis and guidance for the appropriate transfusion practice in an emergency.

Ensuring Adequate Human Medical Resources during an Avian Influenza A/H5N1 Pandemic

When countermeasures are taken against an avian influenza (AI) pandemic in a hospital, it is essential to know the potential number of staff who would choose to be absent. The purpose of this study was to clarify how many medical staff would be willing to work during a pandemic, and requirements to secure adequate human resources. From September to December 2008, a total of 3,152 questionnaires were sent to five private hospitals and one public hospital, which represent the core hospitals in the regions of Kyoto, Osaka, and Hyogo Prefectures. Participants consisted of hospital staff including: (1) physicians; (2) nurses; (3) pharmacists; (4) radiological technologists (RTs); (5) physical therapists (PTs); (6) occupational therapists (OTs); (7) clinical laboratory technologists (CLTs); (8) caregivers; (9) office clerks; and (10) others. They were queried about their attitude toward pandemics, including whether they would come to the hospital to work, treat patients, and what kinds of conditions they required in order to work. A total of 1,975 persons (62.7%) responded. A total of 204 persons (10.6%) would not come to the hospitals during a pandemic, 363 (18.8%) would perform their duties as usual, unconditionally, 504 (26.1%) would come to hospitals but not treat AI patients, and 857 (44.5%) would report to the hospital and treat AI patients with some essential conditions. These essential conditions were: (1) personal protective equipment (PPE) (80.0%); (2) receipt ofworkmen's compensation (69.3%); (3) receipt of anti-virus medication (58.2%); and (3) receipt of pre-pandemic vaccination (57.8%). During a pandemic, all types of health professionals would be lacking, not only physicians and nurses. This study indicates that ensuring sufficient medical human resources would be difficult without the provision of adequate safety and compensation measures.

Potential work‐related bloodborne pathogen exposures by industry and occupation in the United States Part I: An emergency department‐based surveillance study

Since the early 1990s, researchers have attempted to assess the magnitude of potential work-related bloodborne pathogen (BBP) exposures in the U.S. The only data-derived estimate of 385,000 needlestick and other sharps injuries per year was reported in 2004. The estimate was derived from a convenience sample and did not include exposures outside of hospitals. This study seeks to understand the magnitude and distribution of the exposures across all industries and occupations. Data were from the 1998 to 2000 National Electronic Injury Surveillance System (NEISS), a stratified probability-based sample of U.S. hospital emergency departments (EDs). NEISS covers all industries and occupations. National estimates of exposures and exposure rates (the number of exposures/1,000 full-time equivalents (FTE)) were computed. An estimated 78,100 potential work-related exposures to BBP were treated in hospital EDs annually in the U.S. While hospitals accounted for 75% of all these exposures, 11 other industries had a substantial number of exposures. While registered nurses accounted for 36% of all exposures, 13 other occupations had a substantial number of exposures. Hospitals had the highest exposure rate of 11.3/1,000 FTE, followed by nursing homes (2.8), and residential care facilities without nursing (1.9). Registered nurses had the highest exposure rate of 15.3/1,000 FTE, followed by clinical laboratory technologists and technicians (13.9), and physicians (7.1). While this study begins to more completely describe the problem of potential BBP exposure in the workplace, it is but a first step in further understanding the complex issues surrounding workplace BBP exposures.

2003 workforce survey of hospital clinical laboratories in New Jersey.

1. Elaine M Keohane, PhD CLS(NCA)[⇑][1] 1. is Professor, Department of Clinical Laboratory Sciences, University of Medicine and Dentistry of New Jersey, Newark NJ 2. Mary Ellen Schaad, MT(ASCP) 1. is Technical Manager, Clinical Laboratory, Meridian Health System, Neptune NJ 3. Karen Feeney, MPA MT(ASCP)DLM 1. is Administrative Director, Department of Laboratories, Bayshore Community Hospital, Holmdel NJ 1. Address for correspondence: Elaine M Keohane PhD CLS(NCA), University of Medicine and Dentistry of New Jersey, School of Health Related Professions, 65 Bergen Street, Newark NJ 07107. (973) 972-5510, (973) 972-8527 (fax). keohanem{at}umdnj.edu The clinical laboratory personnel shortage has reached significant proportions in many areas of the country and there is growing concern about its impact on the accessibility and quality of clinical laboratory services. For the years 2002–2012, the U.S. Bureau of Labor Statistics projected a need for 138,000 new clinical laboratory technologists and technicians, or approximately 13,800 per year, due to growth and attrition from the field.1 On the other hand, in 2002, there were only 3,548 clinical laboratory technician/medical laboratory technician (CLT/MLT) and clinical laboratory scientist/medical technologist (CLS/MT) graduates in the U.S.2 If the current imbalance between vacancies and graduates continues, the national shortage of clinical laboratory personnel may grow by more than 10,000 laboratorians per year. In surveys conducted by the American Society for Clinical Pathology (ASCP), vacancy rates in 2000 for medical technologists (MTs) and medical laboratory technicians (MLTs) were 11.1% and 14.3% nationally and 14.9% and 24.5% in the northeast; in 2002 those rates showed a decrease to 7% and 8.6% nationally and 8.3% and 3.5% in the northeast. Although the vacancy rates in the latter study decreased to single digits, the vacancies are nevertheless noteworthy in terms of the actual number of vacant positions, taking into consideration a national workforce estimated at 297,000 clinical laboratory technologists and technicians.1 A Coalition for New Jersey Clinical Laboratory Personnel was formed in April 2002 to study the extent of and address a perceived shortage of clinical laboratory personnel in New Jersey. This coalition consists of twenty-eight members representing hospital… ABBREVIATIONS: CT = cytotechnologist; HLT = histotechnologist; HT = histotechnician; MLT = medical laboratory technician; MT = medical technologist. [1]: #corresp-1

Training and continuous education of clinical laboratory technologists and technicians

The profession of clinical laboratory technologist has undergone profound changes in the last decades and scientific as well as technological advancement will cause further continued evolution. Therefore, adaptability to a rapidly evolving environment and willingness to continuously update knowledge as well as skills seem to be the most important demands confronting technologists. I compare the current training of clinical laboratory technologist in industrialized countries with emerging educational schemes, which include curricula based on national requirements comprising a total of 3–4 years of formal lectures and practical training.