Laboratory medicine最新文献

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Serum Ribonucleotide Reductase Subunit M2 in Patients with Chronic Liver Diseases and Hepatocellular Carcinoma. 慢性肝病和肝细胞癌患者血清核糖核苷酸还原酶亚基M2的研究
Laboratory medicine Pub Date : 2023-11-02 DOI: 10.1093/labmed/lmad013
Xuehang Jin, Wei Yu, Ange Wang, Yunqing Qiu
{"title":"Serum Ribonucleotide Reductase Subunit M2 in Patients with Chronic Liver Diseases and Hepatocellular Carcinoma.","authors":"Xuehang Jin, Wei Yu, Ange Wang, Yunqing Qiu","doi":"10.1093/labmed/lmad013","DOIUrl":"10.1093/labmed/lmad013","url":null,"abstract":"<p><strong>Background: </strong>Ribonucleotide reductase subunit M2 (RRM2) plays a key role in cell and hepatitis B virus (HBV) replication. Nevertheless, its clinical implications for managing liver diseases have been inadequately studied.</p><p><strong>Methods: </strong>A total of 412 participants were enrolled, including 60 healthy control individuals, 55 patients with chronic hepatitis B (CHB), 173 patients with cirrhosis, and 124 patients with hepatocellular carcinoma (HCC). Serum RRM2 was measured via ELISA.</p><p><strong>Results: </strong>The level of serum RRM2 in patients with CHB, cirrhosis, and HCC was higher than that in healthy controls (P < .05). A large difference in serum RRM2 was found between HBV-related and non-HBV-related patients in the cirrhosis group (P < .001), compared with the difference between HBV-related HCC and non-HBV-related HCC (P = .86). In the HBV-related cirrhosis group, the serum RRM2 level showed significant positive correlations with HBV DNA, hepatitis B surface antigen, hepatitis B e antigen, Child-Pugh scores, and MELD scores and played a strong role in diagnosing HBV-related cirrhosis in CHB, compared with fibrosis-4 score and aspartate aminotransferase-to-platelet ratio index.</p><p><strong>Conclusions: </strong>Serum RRM2 is a reliable biomarker for accurate HBV-related cirrhosis diagnosis and evaluation. Also, serum RRM2 could reflect the expression state of HBV replication in patients with HBV-related cirrhosis.</p>","PeriodicalId":17951,"journal":{"name":"Laboratory medicine","volume":" ","pages":"626-632"},"PeriodicalIF":0.0,"publicationDate":"2023-11-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9210526","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A population-based characterization study of 
anti-mitochondrial M2 antibodies and its consistency with anti-mitochondrial antibodies. 以人群为基础的
抗线粒体M2抗体的特征研究及其与抗线粒体抗体的一致性
Laboratory medicine Pub Date : 2023-11-02 DOI: 10.1093/labmed/lmad018
En-Yu Liang, Miao Liu, Pei-Feng Ke, Guang Han, Cheng Zhang, Li Deng, Yun-Xiu Wang, Hui Huang, Wu-Jiao Huang, Rui-Ping Liu, Guo-Hua Li, Ze-Min Wan, Yi-Ting He, Min He, Xian-Zhang Huang
{"title":"A population-based characterization study of \u2028anti-mitochondrial M2 antibodies and its consistency with anti-mitochondrial antibodies.","authors":"En-Yu Liang, Miao Liu, Pei-Feng Ke, Guang Han, Cheng Zhang, Li Deng, Yun-Xiu Wang, Hui Huang, Wu-Jiao Huang, Rui-Ping Liu, Guo-Hua Li, Ze-Min Wan, Yi-Ting He, Min He, Xian-Zhang Huang","doi":"10.1093/labmed/lmad018","DOIUrl":"10.1093/labmed/lmad018","url":null,"abstract":"<p><strong>Objective: </strong>This study aims to estimate the prevalence of anti-mitochondrial antibody subtype M2 (AMA-M2) and assess its consistency with AMA in a general population.</p><p><strong>Methods: </strong>A total of 8954 volunteers were included to screen AMA-M2 using enzyme-linked immunosorbent assay. Sera with AMA-M2 >50 RU/mL were further tested for AMA using an indirect immunofluorescence assay.</p><p><strong>Results: </strong>The population frequency of AMA-M2 positivity was 9.67%, of which 48.04% were males and 51.96% were females. The AMA-M2 positivity in males had a peak and valley value of 7.81% and 16.88% in those aged 40 to 49 and ≥70 years, respectively, whereas it showed a balanced age distribution in females. Transferrin and immunoglobulin M were the risk factors for AMA-M2 positivity and exercise was the only protective factor. Of 155 cases with AMA-M2 >50 RU/mL, 25 cases were AMA-positive, with a female-to-male ratio of 5.25:1. Only 2 people, with very high AMA-M2 of 760 and >800 RU/mL, met the diagnostic criteria of primary biliary cholangitis (PBC), making the prevalence of PBC 223.36 per million in southern China.</p><p><strong>Conclusion: </strong>We found that AMA-M2 has a low coincidence rate with AMA in the general population. A new decision-making point for AMA-M2 is needed to improve consistency with AMA and diagnostic accuracy.</p>","PeriodicalId":17951,"journal":{"name":"Laboratory medicine","volume":" ","pages":"618-625"},"PeriodicalIF":0.0,"publicationDate":"2023-11-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9277212","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Serum expression of tumor marker CA242 in patients with different gynecological diseases. 不同妇科疾病患者血清肿瘤标志物CA242的表达
Laboratory medicine Pub Date : 2023-11-02 DOI: 10.1093/labmed/lmad017
Jing Zhu, Huidan Li
{"title":"Serum expression of tumor marker CA242 in patients with different gynecological diseases.","authors":"Jing Zhu, Huidan Li","doi":"10.1093/labmed/lmad017","DOIUrl":"10.1093/labmed/lmad017","url":null,"abstract":"<p><strong>Objective: </strong>The aim of this study was to investigate the serum levels of CA242 in different types of gynecological diseases and its clinical significance.</p><p><strong>Methods: </strong>A total of 1021 patients with gynecological diseases and 499 healthy female controls were included in the study. The serum CA242 levels were detected and median value, -log10P value, and positive rate were calculated. Serum CA125 and HE4 levels of patients with ovarian lesions were measured, and the predictive value for ovarian cancer was statistically analyzed.</p><p><strong>Results: </strong>Higher serum CA242 levels were observed in patients with mature teratoma, ovarian cancer, and other gynecological tumor diseases than in healthy controls. In contrast, the CA242 levels in patients with cervical intraepithelial neoplasia, uterine polyps, or endometrial hyperplasia were comparable to that of controls. Moreover, serum CA242 expression was increased in malignant uterine and ovarian diseases compared with benign ones (P < .05). Specifically, combining CA242, CA125, and HE4 yielded a higher area under the receiver operating characteristic curve than single biomarkers (P < .05).</p><p><strong>Conclusion: </strong>Heterogeneous increases in tumor marker CA242 expression levels are observed in different gynecological diseases, suggesting its potential value for clinical diagnosis.</p>","PeriodicalId":17951,"journal":{"name":"Laboratory medicine","volume":" ","pages":"613-617"},"PeriodicalIF":0.0,"publicationDate":"2023-11-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9404005","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The importance of the trisomy 21 local cutoff value evaluation for prenatal screening in the second trimester of pregnancy. 21三体局部临界值评估在妊娠中期产前筛查中的重要性。
Laboratory medicine Pub Date : 2023-11-02 DOI: 10.1093/labmed/lmad015
Chen Yiming, Yijie Chen, Long Sun, Liyao Li, Wenwen Ning
{"title":"The importance of the trisomy 21 local cutoff value evaluation for prenatal screening in the second trimester of pregnancy.","authors":"Chen Yiming, Yijie Chen, Long Sun, Liyao Li, Wenwen Ning","doi":"10.1093/labmed/lmad015","DOIUrl":"10.1093/labmed/lmad015","url":null,"abstract":"<p><strong>Objective: </strong>The aim of this work was to compare different local cutoff values (LCV) and inline cutoff values (ICV) in pregnant women in the second trimester at high risk for carrying fetuses with trisomy 21.</p><p><strong>Methods: </strong>This retrospective cohort study analyzed prenatal screening outcomes in pregnant women (n = 311,561). The receiver operating characteristic curve was used to evaluate the diagnostic significance of the trisomy 21 risk value, alpha-fetoprotein, and free beta human chorionic gonadotropin multiple of the median for predicting trisomy 21 risk. The cutoff value corresponding to the maximal Youden index was taken as the LCV. The screening efficiency of both cutoff values was compared.</p><p><strong>Results: </strong>The LCV cutoff value was lower than the ICV cutoff value (1/643 vs 1/270). The sensitivity increased by 19.80%, the positive predictive value decreased by 0.20%, and the false-positive rate increased by 6.50%.</p><p><strong>Conclusion: </strong>The LCV should be used to determine trisomy 21 risk, which can increase the detection rate of trisomy 21 in the second trimester.</p>","PeriodicalId":17951,"journal":{"name":"Laboratory medicine","volume":" ","pages":"603-607"},"PeriodicalIF":0.0,"publicationDate":"2023-11-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9283433","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The exclusion of anti-D alloantibody in a suspected anti-G antibody in a pregnant 28-year-old Odiya Indian woman. 一名28岁印度奥迪亚孕妇疑似抗g抗体中排除抗d同种异体抗体。
Laboratory medicine Pub Date : 2023-11-02 DOI: 10.1093/labmed/lmad067
Kella Nivedita, Somnath Mukherjee, Satya Prakash, Ansuman Sahu, Debasish Mishra
{"title":"The exclusion of anti-D alloantibody in a suspected anti-G antibody in a pregnant 28-year-old Odiya Indian woman.","authors":"Kella Nivedita, Somnath Mukherjee, Satya Prakash, Ansuman Sahu, Debasish Mishra","doi":"10.1093/labmed/lmad067","DOIUrl":"10.1093/labmed/lmad067","url":null,"abstract":"<p><p>The Rh-D negative pregnancy is commonly associated with alloimmunization against D-antigen. It can be prevented by anti-D prophylaxis in pregnant patients with negative results on antibody screening. Hence, it is essential to exclude alloantibody-D in the presence of multiple alloantibodies. Anti-G antibody is formed after exposure to G antigen in neonate RBCs. Blood-group discrepancy was noted in reverse grouping, and antibody-screening results were positive in our case individual, a 28-year old Odiya Indian woman. We performed antibody identification on serum specimens from this patient, which revealed the pattern of anti-D + anti-C antibody specificity. Blood-group discrepancy was solved using rr (ce/ce)-phenotype pooled cells for reverse grouping. We identified anti-G antibodies by themselves without anti-D and anti-C after performing sequential adsorption of serum with r'r' (Ce/Ce) and R2R2 (DcE/DcE) group-O RBCs in the mother, who had rr phenotype and primigravida designation. After completing antibody screening at the first antenatal check-up, we recommended prophylactic anti-D for the mother in any future pregnancies she may have.</p>","PeriodicalId":17951,"journal":{"name":"Laboratory medicine","volume":" ","pages":"e197-e200"},"PeriodicalIF":0.0,"publicationDate":"2023-11-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10295720","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Application of the FMEA Method in Improving the Quality Management of Emergency Complete Blood Count Testing. FMEA方法在提高急诊全血细胞计数检测质量管理中的应用。
Laboratory medicine Pub Date : 2023-11-02 DOI: 10.1093/labmed/lmad002
Shuangshuang Lv, Yingqian Sun, Jian Zhang, Tingting Jin, Xiaxuan Hu
{"title":"Application of the FMEA Method in Improving the Quality Management of Emergency Complete Blood Count Testing.","authors":"Shuangshuang Lv, Yingqian Sun, Jian Zhang, Tingting Jin, Xiaxuan Hu","doi":"10.1093/labmed/lmad002","DOIUrl":"10.1093/labmed/lmad002","url":null,"abstract":"<p><strong>Objective: </strong>Failure mode and effects analysis (FMEA) was used to identify factors that contribute to quality management deficiencies in laboratory testing of emergency complete blood count (CBC).</p><p><strong>Methods: </strong>Improvements included instrument updates, personnel training, and laboratory information system optimization. We used operational data from January 2021 (control group) and January 2022 (FMEA group) to compare the risk priority number (RPN) of FMEA, emergency CBC laboratory turnaround time (TAT), error report rate, and specimen failure rate.</p><p><strong>Results: </strong>After the implementation of FMEA, the average RPN dropped from 36.24 ± 9.68 to 9.45 ± 2.25, (t = 20.89, P < .05). Additionally, the median TAT for emergency CBCs decreased from 23 min to 11 min as did the interquartile distance (17-34 min to 8-16 min) (P < .05). The rate of emergency CBC error reports decreased from 1.39% to 0.71% (P < .05), and the specimen failure rate decreased from 0.95% to 0.32% (P < .05). Patient satisfaction also increased from 43% to 74% (P < .05), and the technician-performed morphology assessment pass rate increased from 16.7% to 100% (P < .05).</p><p><strong>Conclusion: </strong>Improving the emergency CBC testing process with FMEA can shorten emergency CBC laboratory TAT and reduce specimen failure rates and reporting error rates. The FMEA can be used to improve quality management in emergency CBC laboratories.</p>","PeriodicalId":17951,"journal":{"name":"Laboratory medicine","volume":" ","pages":"574-581"},"PeriodicalIF":0.0,"publicationDate":"2023-11-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10821323","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Semaphorin 3A levels in vascular and nonvascular phenotypes in systemic sclerosis. 信号蛋白3A在系统性硬化症血管和非血管表型中的水平。
Laboratory medicine Pub Date : 2023-11-02 DOI: 10.1093/labmed/lmad019
Mehmet Kayaalp, Abdulsamet Erden, Hakan Apaydin, Serdar Can Güven, Berkan Armağan, Merve Cağlayan Kayaalp, Esma Andac Uzdogan, Şeymanur Ala Enli, Ahmet Omma, Orhan Kucuksahin
{"title":"Semaphorin 3A levels in vascular and nonvascular phenotypes in systemic sclerosis.","authors":"Mehmet Kayaalp, Abdulsamet Erden, Hakan Apaydin, Serdar Can Güven, Berkan Armağan, Merve Cağlayan Kayaalp, Esma Andac Uzdogan, Şeymanur Ala Enli, Ahmet Omma, Orhan Kucuksahin","doi":"10.1093/labmed/lmad019","DOIUrl":"10.1093/labmed/lmad019","url":null,"abstract":"<p><strong>Objective: </strong>Semaphorin 3A (Sema3A) plays a regulatory role in immune responses. The aim of this study was to evaluate Sema3A levels in patients with systemic sclerosis (SSc), especially in major vascular involvements such as digital ulcer (DU), scleroderma renal crisis (SRC), pulmonary arterial hypertension (PAH), and to compare Sema3A level with SSc disease activity.</p><p><strong>Methods: </strong>In SSc patients, patients with DU, SRC, or PAH were grouped as major vascular involvements and those without as nonvascular, and Sema3A levels were compared between the groups and with a healthy control group. The Sema3A levels and acute phase reactants in SSc patients, as well as their association with the Valentini disease activity index and modified Rodnan skin score, were evaluated.</p><p><strong>Results: </strong>The Sema3A values (mean ± SD) were 57.60 ± 19.81 ng/mL in the control group (n = 31), 44.32 ± 5.87 ng/mL in patients with major vascular involvement SSc (n = 21), and 49.96 ± 14.00 ng/mL in the nonvascular SSc group (n = 35). When all SSc patients were examined as a single group, the mean Sema3A value was significantly lower than controls (P = .016). The SSc with major vascular involvement group had significantly lower Sema3A levels than SSc with nonmajor vascular involvement group (P = .04). No correlation was found between Sema3A, acute phase reactants, and disease activity scores. Also, no relationship was observed between Sema3A levels and diffuse (48.36 ± 11.47 ng/mL) or limited (47.43 ± 12.38 ng/mL) SSc types (P = .775).</p><p><strong>Conclusion: </strong>Our study suggests that Sema3A may play a significant role in the pathogenesis of vasculopathy and can be used as a biomarker in SSc patients with vascular complications such as DU and PAH.</p>","PeriodicalId":17951,"journal":{"name":"Laboratory medicine","volume":" ","pages":"646-651"},"PeriodicalIF":0.0,"publicationDate":"2023-11-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9352473","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
Plasmablastic transformation of chronic lymphocytic leukemia: a review of literature and report on 2 cases. 慢性淋巴细胞白血病的质母细胞转化:文献复习并附2例报告。
Laboratory medicine Pub Date : 2023-11-02 DOI: 10.1093/labmed/lmad060
Anurag Khanna, Bradley R Drumheller, George Deeb, Ethan Wade Tolbert, Saja Asakrah
{"title":"Plasmablastic transformation of chronic lymphocytic leukemia: a review of literature and report on 2 cases.","authors":"Anurag Khanna, Bradley R Drumheller, George Deeb, Ethan Wade Tolbert, Saja Asakrah","doi":"10.1093/labmed/lmad060","DOIUrl":"10.1093/labmed/lmad060","url":null,"abstract":"<p><p>Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) is the most common leukemia in adults in Western countries. Transformation of CLL/SLL to plasmablastic lymphoma (PBL) is exceedingly rare and often has an extremely poor response to treatment. A thorough molecular workup may help in determining clonality-relatedness and prognosis. We describe two cases of CLL/SLL that transformed into PBL, with an extensive molecular workup in one case, and a review of the literature.</p>","PeriodicalId":17951,"journal":{"name":"Laboratory medicine","volume":" ","pages":"e177-e185"},"PeriodicalIF":0.0,"publicationDate":"2023-11-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9781157","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Utilization of an immunochromatographic lateral flow assay for rapid detection of carbapenemase production in gram negative bacilli. 利用免疫层析横向流动法快速检测革兰氏阴性杆菌碳青霉烯酶的产生。
Laboratory medicine Pub Date : 2023-11-02 DOI: 10.1093/labmed/lmad090
Emily Sullivan, Maria D Macias Jimenez, Nicholas M Moore
{"title":"Utilization of an immunochromatographic lateral flow assay for rapid detection of carbapenemase production in gram negative bacilli.","authors":"Emily Sullivan, Maria D Macias Jimenez, Nicholas M Moore","doi":"10.1093/labmed/lmad090","DOIUrl":"10.1093/labmed/lmad090","url":null,"abstract":"<p><strong>Background: </strong>Rapid detection of carbapenemase production in gram negative bacilli has important treatment considerations.</p><p><strong>Objective: </strong>We evaluated a lateral flow assay (LFA) for carbapenemase production compared with molecular detection of 5 (blaKPC, blaNDM, blaVIM, blaIMP, and blaOXA-48) carbapenemase genes.</p><p><strong>Methods: </strong>A total of 218 carbapenem nonsusceptible strains, including species of Enterobacterales, Pseudomonas aeruginosa isolated from clinical cultures were tested using the Cepheid Xpert Carba-R assay and the NG Biotech Carba-5 lateral flow immunoassay.</p><p><strong>Results: </strong>Overall agreement with LFA was 98.2% with accuracy for each target >99% compared with polymerase chain reaction. Results were available within 15 minutes compared with 1 hour for molecular detection.</p><p><strong>Conclusion: </strong>The use of accurate, rapid diagnostics compliments antimicrobial stewardship programs.</p>","PeriodicalId":17951,"journal":{"name":"Laboratory medicine","volume":" ","pages":"e204-e206"},"PeriodicalIF":0.0,"publicationDate":"2023-11-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10142935","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A novel internal training program using Kern's 6-step approach to curriculum development for medical laboratory scientists training to be international quality assurance/quality control coordinators. 采用Kern的六步法为医学实验室科学家培训国际质量保证/质量控制协调员提供一个新颖的内部培训计划。
Laboratory medicine Pub Date : 2023-11-02 DOI: 10.1093/labmed/lmad068
Anne Leach, Josephine Shim, Kristin Murphy, Mandana Godard, Felix Ortiz, Mark Swartz, Lori J Sokoll
{"title":"A novel internal training program using Kern's 6-step approach to curriculum development for medical laboratory scientists training to be international quality assurance/quality control coordinators.","authors":"Anne Leach, Josephine Shim, Kristin Murphy, Mandana Godard, Felix Ortiz, Mark Swartz, Lori J Sokoll","doi":"10.1093/labmed/lmad068","DOIUrl":"10.1093/labmed/lmad068","url":null,"abstract":"<p><strong>Objective: </strong>Patient Safety Monitoring in International Laboratories (pSMILE) is a resource ensuring quality testing in clinical laboratories performing National Institutes of Health-funded HIV research requiring specific staff training. We demonstrate the development of an online asynchronous training model using Kern's 6-step approach to support pSMILE functions.</p><p><strong>Methods: </strong>An existing curriculum was revamped to incorporate Kern's approach. Metrics for success were described in rubrics with feedback guiding improvements and updates.</p><p><strong>Results: </strong>Curriculum updates took more than a year. Direct observations of skills informed curriculum changes. Module self-evaluations were reviewed to assess performance and the overall curriculum. The content, curriculum, and training documentation were deemed compliant with International Organization for Standardization (ISO) 9001:2015.</p><p><strong>Conclusion: </strong>Asynchronous training for highly skilled and self-directed staff is a novel way to deploy training while maintaining productivity of existing staff. Feedback and evaluation allowed for curriculum updates including previously underdeveloped topics. Kern's approach ensured that the needs of the sponsor, management, laboratories, and learners were met.</p>","PeriodicalId":17951,"journal":{"name":"Laboratory medicine","volume":" ","pages":"e186-e196"},"PeriodicalIF":0.0,"publicationDate":"2023-11-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10629921/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9828801","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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