Background: The quality of laboratory test results is crucial for accurate clinical diagnosis and treatment. Pre-analytical errors account for approximately 60%–70% of all laboratory test errors. Laboratory test results may be largely impacted by pre-analytical phase management. However, primary care clinics currently do not have pre-analytical quality management audit systems. We aimed to understand the current status of pre-analytical quality management in laboratory medicine in Korean primary care clinics. Methods: Questionnaires were designed to focus on essential components of the pre-analytical process of primary care clinics. An online survey platform was used to administer the survey to internal medicine or family medicine physicians in primary care clinics. Results: A total of 141 physicians provided a complete response to the questionnaire. In 65.2% of the clinics, patient information was hand-labeled rather than barcoded on the specimen bottles; 14.2% of clinics displayed only one piece of patient information (name or identification number), and 19.9% of clinics displayed two pieces of information. Centrifuges were not available in 29.1% of the clinics. Institutions carrying out the National Health Screening Program (NHSP) used more barcode system and had more centrifuges than institutions that did not carrying out the NHSP. Conclusions Pre-analytical quality management is inadequate in many primary clinics. We suggest implementation of a mandatory management system, allowing for a pre-analytical quality management to be carried out in primary care clinics.

Background: Nurses play a central role in the process of blood transfusion because they have the closest interactions with patients. Providing nurses with the appropriate knowledge and competency through education can help ensure transfusion safety. This study investigated the effectiveness of the first nationwide transfusion-related education for nurses by analyzing questionnaires for a self-assessment of competency on transfusion-related knowledge before and after the education and general evaluation for the educational program. Methods: The education program was composed of four lectures and was conducted in seven regions in South Korea. One hundred and ninety-two nurses participated, and the questionnaires for 170 nurses were analyzed. Results: The participants consisted of 90 nurses (53.0%) from tertiary hospitals, 23 (13.5%) from general hospitals, and 57 (33.5%) from other hospitals. The majority of the participants (103/170, 60.6%) were from hospitals with ≥500 beds, and 69.4% had a work period of ≥10 years. The scores for pre-/post-education self-assessment of competency were as follows: blood components, 3.03/3.73; pretransfusion testing, 2.86/3.64; management of transfusion, 3.18/3.84; and transfusion reactions, 3.11/3.78. In all categories, there was a significant increase in the score after the education program. The majority of participants (99.4%) provided a positive response regarding the necessity of a transfusion-related education program. Conclusion South Korea’s first attempt at transfusion-related education for nurses showed a strong positive effect by improving participants’ transfusion-related competency. Considering the important role of nurses in blood transfusion, the educational program should continue and be expanded in the future.

Background: Nurses play a central role in the process of blood transfusion because they have the closest interactions with patients. Providing nurses with the appropriate knowledge and competency through education can help ensure transfusion safety. This study investigated the effectiveness of the first nationwide transfusion-related education for nurses by analyzing questionnaires for a self-assessment of competency on transfusion-related knowledge before and after the education and general evaluation for the educational program. Methods: The education program was composed of four lectures and was conducted in seven regions in South Korea. One hundred and ninety-two nurses participated, and the questionnaires for 170 nurses were analyzed. Results: The participants consisted of 90 nurses (53.0%) from tertiary hospitals, 23 (13.5%) from general hospitals, and 57 (33.5%) from other hospitals. The majority of the participants (103/170, 60.6%) were from hospitals with ≥500 beds, and 69.4% had a work period of ≥10 years. The scores for pre-/post-education self-assessment of competency were as follows: blood components, 3.03/3.73; pretransfusion testing, 2.86/3.64; management of transfusion, 3.18/3.84; and transfusion reactions, 3.11/3.78. In all categories, there was a significant increase in the score after the education program. The majority of participants (99.4%) provided a positive response regarding the necessity of a transfusion-related education program. Conclusion South Korea’s first attempt at transfusion-related education for nurses showed a strong positive effect by improving participants’ transfusion-related competency. Considering the important role of nurses in blood transfusion, the educational program should continue and be expanded in the future.

BACKGROUND: For creatinine measurement, the enzymatic method is known to be more accurate than the Jaffe method; however, the latter is still widely used. We evaluated the performance of the CRE2 reagent (Siemens Healthcare Diagnostics Inc., USA), which uses a modified Jaffe method. METHODS: Three quality control standards were used for precision evaluations of CRE2 on Dimension VISTA 500 instrument (Siemens). Moreover, the linearity and carryover characteristics were assessed. Sixty-eight creatinine results obtained using the CRE2 and ECREA (enzymatic) reagents (Siemens) were compared with those obtained using the L-CRE (enzymatic) reagent (Shinyang Diagnostics, Korea). The accuracy of CRE2, ECREA, and L-CRE was evaluated using a standard reference material. RESULTS: The CV of within-run (0.7–2.4%), between-run (0.4–1.7%), between-day precision (0.7–0.9%) for three standards, and total CV for medium (1.6%) and high levels (1.3%) satisfied the analytical goal. The linearity for CRE2 was excellent (R2=0.999). Comparisons of CRE2 and ECREA to L-CRE were well correlated (r=0.996 and 0.997, respectively). In comparison with L-CRE, 5 CRE2 results and 15 ECREA results exceeded minimum bias goal (5.1%) in samples with creatinine levels of >1 mg/dL. The carryover rate was −0.04%. In terms of accuracy, the percent bias values of CRE2, ECREA, and L-CRE were 7.4, −6.4, and −3.4, respectively, for low level; and 3.9, −1.5, and 0.7, respectively, for high level. CONCLUSIONS: For creatinine measurements, the CRE2 reagent showed good performance. It can be used in the diagnosis, treatment monitoring, and risk assessment of kidney diseases.
Bias (Epidemiology) ; Creatinine* ; Delivery of Health Care ; Diagnosis ; Indicators and Reagents ; Kidney Diseases ; Methods ; Quality Control ; Risk Assessment

BACKGROUND: Analysis of body fluids provides important information for assessing various medical conditions. We aimed to validate the analytical and diagnostic performance of the Sysmex UF-5000 (Sysmex, Japan) system for the analysis of different body fluids. METHODS: Eighty body fluid samples were analyzed using the UF-5000 system in the body fluid mode and light microscopy. Body fluids included ascitic, pleural, and cerebrospinal fluid (CSF), as well as other fluid samples. RESULTS: A comparison between the UF-5000 system and manual counting demonstrated good correlations with regard to red (r=0.6555) and white blood cell (r=0.9666) counts. The UF-5000 system also demonstrated good performance for differential cell counting (r=0.9028). CSF particularly showed a good correlation. CONCLUSIONS: The use of the UF-5000 system for cell counting and differential analysis of body fluid samples might be an effective and automated alternative to chamber counting in laboratory routine analysis, thereby enhancing laboratory workflow and clinical effectiveness.
Automation ; Body Fluids ; Cell Count ; Cerebrospinal Fluid ; Erythrocytes ; Leukocytes ; Methods ; Microscopy ; Treatment Outcome

BACKGROUND: Automated systems are used widely for pre-transfusion tests in blood banks, in an attempt to reduce effort and human error. We evaluated the clinical performance of an automated blood bank system, ORTHO VISION (Ortho-Clinical Diagnostics, Switzerland), for blood cross-matching. METHODS: Saline cross-matching was performed for 93 tests using 56 samples. Coombs cross-matching was performed for 400 tests using 166 samples. Saline cross-matching was compared for the automated ORTHO VISION and manual tube methods. Coombs cross-matching was compared for the automated ORTHO VISION and manual column agglutination technique (CAT) methods. The evaluation of 32 antibody-positive samples using the automated ORTHO VISION and manual CAT methods was compared by performing 97 cross-matching tests. Additionally, the ORTHO VISION efficiency and carryover were evaluated. RESULTS: The concordance rate of the saline cross-matching results between the manual method and automated ORTHO VISION was 100%. The concordance rate of coombs cross-matching results between manual CAT and automated ORTHO VISION was 97.9%. The concordance rate of cross-matching for antibody positive samples between manual CAT and the automated ORTHO VISION was 97.9%. Coombs cross-matching was efficient using ORTHO VISION, whereas saline cross-matching was efficient using the tube manual method. CONCLUSIONS: ORTHO VISION showed reliable results for cross-matching and was more efficient than manual CAT for coombs cross-matching. Thus, ORTHO VISION can be used for pre-transfusion tests in blood banks.
Agglutination ; Animals ; Automation ; Blood Banks ; Cats ; Humans ; Methods

BACKGROUND: Tumor-infiltrating lymphocytes, which form a part of the host immune system, affect the development and progression of cancer. This study investigated whether subsets of lymphocytes reflecting host-tumor immunologic interactions are related to the prognosis of patients with acute myeloid leukemia (AML). METHODS: Lymphocyte subsets in the peripheral blood of 88 patients who were newly diagnosed with AML were analyzed by quantitative flow cytometry. The relationships of lymphocyte subsets with AML subtypes, genetic risk, and clinical courses were analyzed. RESULTS: The percentages of T and NK cells differed between patients with acute promyelocytic leukemia (APL) and those with AML with myelodysplasia-related changes. In non-APL, a high proportion of NK cells (>16.6%) was associated with a higher rate of death before remission (P=0.0438), whereas a low proportion of NK cells (≤9.4%) was associated with higher rates of adverse genetic abnormalities (P=0.0244) and relapse (P=0.0567). A multivariate analysis showed that the lymphocyte subsets were not independent predictors of survival. CONCLUSION: Lymphocyte subsets at diagnosis differ between patients with different specific subtypes of AML. A low proportion of NK cells is associated with adverse genetic abnormalities, whereas a high proportion is related to death before remission. However, the proportion of NK cells may not show independent correlations with survival.
Diagnosis ; Flow Cytometry ; Humans ; Immune System ; Killer Cells, Natural ; Leukemia, Myeloid, Acute* ; Leukemia, Promyelocytic, Acute ; Lymphocyte Subsets* ; Lymphocytes* ; Lymphocytes, Tumor-Infiltrating ; Multivariate Analysis ; Prognosis ; Recurrence

In the 2016 and 2017 programs for blood gas analysis (BGA) in central laboratory and by point-of-care testing (POCT), and glucose analysis by POCT, external quality assessment of 9, 3, and 1 analytes, respectively, was performed each year. The materials used were commercially available quality control materials, and three levels were used per trial. Based on the information and results from each participating laboratory, statistical analysis was carried out. Results were provided to each laboratory through individual and comprehensive reports. The mean response rates were 96.6%, 96.5%, and 95.6% for BGA in central laboratory, BGA (POCT), and glucose (POCT), respectively. The number of participating laboratories in BGA (central laboratory and POCT) in 2017 was not significantly different from that in 2016. However, in the glucose (POCT) program, the number of registered instruments sharply increased in 2017 as the allowable number of registered instruments was increased from 5 to 30. The coefficient of variation (CV) did not show any significant differences in pH, sodium, chloride, and ionized calcium of BGA. However, the differences of CV were found to be relative large between instruments in other analytes of BGA and glucose POCT.
Blood Gas Analysis ; Calcium ; Glucose* ; Hydrogen-Ion Concentration ; Korea* ; Point-of-Care Systems* ; Point-of-Care Testing ; Quality Control ; Sodium

BACKGROUND: The use of automated systems for pre-transfusion tests is increasing in an attempt to reduce workload and the impact of human errors in blood banks. We evaluated the clinical performance of the automated blood bank systems IH-500 (Bio-Rad Laboratories, Switzerland) and VISION Max (Ortho-Clinical Diagnostics, USA) for ABO-RhD blood typing and unexpected antibody screening. METHODS: ABO-RhD blood typing was performed for 410 samples, and antibody screening was performed for 332 samples, including 15 antibody-positive samples. The results obtained from the two automated instruments were compared with those obtained using manual methods for ABO-RhD blood typing and a semiautomated method (DiaMed-ID system) for antibody screening. Additionally, both instruments were evaluated in terms of concordance rates, sensitivity, and carryover. RESULTS: The concordance rate of the ABO-RhD blood typing results between the manual methods and the two automated instruments was 100%. For antibody screening tests, the concordance rates between the semiautomated method (DiaMed-ID system) and the automated methods were 100% and 99.7% for the IH-500 and VISION Max instruments, respectively. The sole discrepant result was obtained for a sample identified as antibody-positive only on the VISION Max; the antibody was identified as anti-Le(a). The overall sensitivity of the two automated instruments was the same as or higher than that of the semiautomated method. Carryover was not observed in antibody screening. CONCLUSIONS: The IH-500 and VISION Max instruments showed reliable results for ABO-RhD blood typing and unexpected antibody screening, and can be used clinically, with confidence, for pre-transfusion tests in the blood bank.
Automation ; Blood Banks* ; Blood Grouping and Crossmatching* ; Humans ; Mass Screening* ; Methods

BACKGROUND: Transfusion is one of the most important treatments in patient care. It has been known that there is a lack of transfusion medicine knowledge of doctors in other countries, however it has not been investigated yet in Korea. In this study, we assessed the educational need and the knowledge on transfusion medicine for trainees to provide basic raw data for future education in transfusion medicine. METHODS: Transfusion is one of the most important treatments in patient care. It has been known that there is a lack of transfusion medicine knowledge of doctors in other countries, however it has not been investigated yet in Korea. In this study, we assessed the educational need and the knowledge on transfusion medicine for trainees to provide basic raw data for future education in transfusion medicine. RESULTS: Among trainees, 89.9% said they received more than one hour of transfusion medicine education at medical schools, but 57.3% did not receive transfusion medicine education after finishing medical school. Moreover, 76.4% and 86.5% of respondents stated that additional transfusion medicine education was needed during and after medical school respectively. Among respondents, 43.5%, 53.9%, and 28.1% reported their knowledge on blood products, pretransfusion testing, and transfusion reactions as low or very low. In the assessment of knowledge of transfusion medicine, the mean percentage of correct answers was 65.2%. The rates of correct answers (average) ranged from 25.8% to 80.9% (58.2%), 49.4% to 94.4% (75.7%) 70.8% to 89.9% (80.2%) in case of blood products, pretransfusion testing, and transfusion reactions respectively. CONCLUSION: Transfusion medicine education among trainees after finishing medical school was found to be insufficient, and additional education for transfusion medicine is demanded by trainees.
Education ; Korea ; Patient Care ; Schools, Medical ; Surveys and Questionnaires ; Transfusion Medicine* ; Transfusion Reaction