In 2017, the Korean Association of External Quality Assessment Service developed a special protein proficiency testing program that consisted of nine quantitative test items. This program was conducted twice a year using three-level control materials. Data and results of each test item were analyzed by respective institutions according to the test instruments. The report was prepared by dividing it into a common report that showed the characteristics of all the participating institutions and an organization-specific report that showed the assessment data of individual institutions. The following statistical data were presented: the number of participating institutions per group, mean, standard deviation, coefficient of variation, median, minimum value, and maximum value. The individual report was composed of a table, histogram, and Levey-Jennings chart showing the statistics for each test item. The results of the assessment of each institution and the statistical data for each classification are presented in a table, and a standard deviation index for both the company classification and classification by instruments was provided. Overall, no significant difference was observed between the number of participating institutions and the distribution of test equipment. The coefficient of variation tended to be relatively high for each test item because the concentration of quality control materials was low and the number of participating institutions was small. I believe that these statistical analysis data are useful for analyzing external quality control results of the institutions and selecting an immunoassay test instrument for special protein.
Classification ; Immunoassay ; Korea* ; Laboratory Proficiency Testing ; Quality Control

In 2017, the Korean Association of External Quality Assessment Service developed a hormone proficiency testing program that comprised 11 test items for hormone I and four test items for hormone II. This program was conducted twice a year using three-level control materials. Data and results of each test item were analyzed by the respective institutions according to the test instruments. The report was prepared by dividing it into a common report that showed the characteristics of the overall participating institutions and an organization-specific report that showed the assessment data of individual institutions. The following statistical data were presented: the number of participating institutions per group, mean, standard deviation, coefficient of variation, median, minimum value, and maximum value. The individual report was composed of a table, histogram, and Levey-Jennings chart showing the statistics for each test item. The results of the assessment of each institution and the statistical data for each classification are presented in a table, and a standard deviation index was provided for both the company classification and classification by instruments. Although the total number of participating institutions and distribution of test instruments were not significantly different from the previous year, the number of participating institutions varied by test item. The coefficient of variation tended to be relatively high for each test item because the concentration of quality control materials was low and the number of participating institutions was small. I believe that these statistical analysis data are useful for analyzing external quality control results of the institutions and selecting an immunoassay test instrument for hormones.
Classification ; Immunoassay ; Korea* ; Laboratory Proficiency Testing ; Quality Control

In both 2016 and 2017, the cytogenetic and molecular cytogenetic programs conducted three assessments for the Korean Association of External Quality Assessment Service. A total of six cases with chromosomal aberrations were distributed in 2016, and nine cases were examined in 2017 in the chromosome surveys. For the fluorescence in situ hybridization surveys, six cases and nine cases were assessed in 2016 and 2017, respectively. A total of 38 laboratories in 2016 and 39 laboratories in 2017 participated in the cytogenetics program. In the molecular cytogenetics program, a total of 32 laboratories participated in 2016, and 31 laboratories participated in 2017. Most of the participating laboratories showed acceptable results for the cytogenetics and molecular cytogenetics programs. For the unacceptable results, there were various annotation errors, suggesting the need for continuous education and quality control.
Chromosome Aberrations ; Cytogenetics* ; Education ; Fluorescence ; In Situ Hybridization ; Korea* ; Laboratory Proficiency Testing ; Quality Control

A new method for qualitative and quantitative analysis of Rhodobryum giganteum by using the nonlinear oscillating chemical was established for improving the quality control standard of R. giganteum. Its potential(E)/time(t) curve was recorded by electrochemical workstation in the oscillation reaction system of BrO~-_3-Ce(SO_4)_2-H_2SO_4-malonic acid/tartaric acid. The nonlinear oscillating chemical fingerprints were investigated for repeatability, and it was found that the RSD values of the four characteristic parameters of R. giganteum were less than 4.1%, indicating a good repeatability and high precision of this experiment. After optimizing the experimental parameters such as particle size, rotation speed and temperature, a new method based on nonlinear oscillating chemical was used for qualitative and quantitative analysis of R. giganteum. The results showed that there was a good linear relationship between the induction time/the period of oscillation and the dosage of herbs(0.1-1.1 g), with the relative coefficients of 0.978 and 0.975, respectively. Besides, the highest potential showed a nonlinear relationship with the dosage of herbs, with the relative coefficient of 0.999. This method was also used to discriminate the R. giganteum and R. roseum. They were similar in appearance, but their fingerprints were quite different. Independent sample t test results showed that there were significant differences in the oscillation time, the maximum amplitude and the induction time, providing a basis for the identification of the basic sources of Herba Rhodobryi Rasei.
Quality Control

In this study, we attempted to improve hospital food delivery service quality and customer satisfaction by using FMEA (Failure Mode and Effect Analysis), which is applied to the quality control of products in manufacturing plants. Subjective food delivery service quality improvement was judged based on a 5-point likert scale. Traditional FMEA uses an RPN (Risk priority number) to evaluate the risk level of a component or process. The RPN index was determined by calculating the product of severity, occurrence, and detection indexes. In our results, total RPN value (P<0.01) significantly decreased after FMEA introduction, whereas customer satisfaction (P<0.001) and food delivery service quality (P<0.001) significantly increased. Specifically, foodservice errors (P<0.01) and loss cost (P<0.01) were significantly improved by FMEA introduction. Taken together, we suggest that FMEA reduces critical activities and errors in foodservice delivery caused by simple priority selection.
Quality Control ; Quality Improvement

BACKGROUND: Currently there is no external proficiency testing program for allergen-specific immunoglobulin E assays (sIgE) in Korea. The aim of this study was to evaluate the accuracy of sIgE performed in different laboratories in Korea using Polycheck Allergy Diagnostic (Biocheck GmbH, Germany) or simply ‘Polycheck’ and to further perform an inter-laboratory comparison of sIgE. METHODS: Three inter-laboratory trials were undertaken from June 2016 to December 2017 at nine institutions. Serum samples obtained from three patients who had a history of positive Polycheck results were used in each trial. A total of 59 allergens were evaluated from the standard panel, inhalation panel, and food panel. The acceptable rates (%) of classes 0–6 of the results were calculated using three different criteria, including the consensus of 80% participants of the College of American Pathologists (CAP), the most frequent value (MFV), and the Overall Misclassification Index Score (OMIS). RESULTS: The proportion of laboratories that showed acceptable results for CAP criteria, MFV, and OMIS were around 93.0%–97.7%, 66.3%–76.0%, and 0.1–1.3, respectively, in each trial. Under-performing institutes showed consistently higher (49/68, 72.1%) or lower (19/68, 27.9%) than acceptable results for all criteria. CONCLUSIONS: This is the first study evaluating the inter-laboratory variation of sIgE in Korea using various criteria. It was found that the acceptable rate could be altered based on changes in these criteria. These findings might be useful for the inter-laboratory comparison of sIgE in Korea in the future as well.
Academies and Institutes ; Allergens ; Consensus ; Humans ; Hypersensitivity ; Immunoglobulin E ; Immunoglobulins ; Inhalation ; Korea ; Laboratory Proficiency Testing ; Mass Screening ; Quality Control

BACKGROUND: This study aimed to investigate the current statuses of eight hormone tests (testosterone, estradiol, prolactin, progesterone, luteinizing hormone, follicle-stimulating hormone, parathyroid hormone, and thyroglobulin) used by clinical laboratories in Korea. METHODS: From November 1 to December 31, 2016, we surveyed 300 laboratories that participated in the regular proficiency survey program administered by the Korean Association of Quality Assurance for Clinical Laboratory. The survey comprised a questionnaire designed to address factors related to these hormone tests, including the measurement methods, instruments, test numbers per month, turnaround times, reporting units and ranges, reference ranges, and internal or external quality control methods. RESULTS: Fifty-four (18.0%) of 300 laboratories replied to the survey questionnaire. Each laboratory performed hormone analyses that used variable instruments, commercial kits, and calibrators. The test numbers per month, turnaround times, and reporting units (particularly for testosterone) varied among laboratories. Most laboratories used reference intervals that had been transferred from other references and were verified using in-house samples. Many laboratories that assessed luteinizing hormone, follicle-stimulating hormone, and parathyroid hormone levels did not participate in the proficiency survey program conducted by The Korean Association of Quality Assurance for Clinical Laboratory. CONCLUSIONS: We hope that the results of this study, which investigated the status of hormone testing at Korean diagnostic laboratories, will facilitate improvements in the quality of hormone testing and promote the development of guidelines for testing.
Clinical Laboratory Services ; Estradiol ; Follicle Stimulating Hormone ; Hope ; Korea* ; Laboratory Proficiency Testing ; Luteinizing Hormone ; Parathyroid Hormone ; Progesterone ; Prolactin ; Quality Control ; Reference Values ; Surveys and Questionnaires

In 2010, the Japan Diabetes Society decided to introduce the National Glycohemoglobin Standardization Program (NGSP) values into clinical practice. Accordingly, NGSP Certification of Japanese manufacturers of HbA(1c)-related diagnostic reagents and instruments was initiated in February, 2012, through an NGSP network laboratory, the Asian Secondary Reference Laboratory (ASRL) #1. Traceability to the NGSP reference system can be endorsed by manufacturer certification, as well as by the College of American Pathologists (CAP) survey. Nevertheless, only a few manufacturers participate in the CAP survey in Japan. Thus, proficiency testing (PT) was proposed and executed by ASRL #1. Single-donor whole-blood samples were used for the PT. The participated measurement systems were NGSP certified. Twenty-two laboratories obtained certification through ASRL #1; 2 through the Secondary Reference Laboratory (SRL) #8; and 9 through the SRL #9. The combination plots of the bias data in this PT and in the NGSP certification performed in March and May in 2012 were consistent with each other: mean NGSP values at each level agreed well with the target value. In conclusion, PT using whole blood is useful in endorsing NGSP certification.
Asia ; Chromatography, High Pressure Liquid ; Enzyme Assays ; Hemoglobin A, Glycosylated/*analysis/standards ; Humans ; Immunoassay ; Japan ; Laboratory Proficiency Testing/*standards ; Quality Control ; Reference Standards ; Republic of Korea ; Societies, Scientific

BACKGROUND: There are few commercial quality-control (QC) materials for internal QC of flow cytometric analysis, especially for leukemia/lymphoma immunophenotyping. The purpose of this study was to investigate the current QC status of flow cytometry in Korea through a questionnaire survey, and develop new QC materials using cultured cell lines for markers which QC materials are unavailable. METHODS: The current state of internal QC of flow cytometry in Korea was investigated via a questionnaire survey. Cell lines to be used as QC materials were cultured and produced as QC materials. Cell viability and the expression of markers on the cultured cell lines were tested by flow cytometry to confirm the stability of the QC materials. Simulated quality assessment results for the cultured cell line QC materials were sent to laboratories for external proficiency testing (PT). RESULTS: Seventeen medical institutions completed the questionnaire survey. Hematopoietic stem cell count (CD34) and lymphocyte subset panel items in most of these institutions were managed using commercialized QC materials. The markers that could not be managed by QC materials were CD117, MPO (myeloperoxidase), TdT (terminal deoxynucleotidyl transferase), CD20, CD10, CD64, CD79α, FMC7, cytoCD22, CD23, CD34, and CD61. Five cell lines expressing these markers were selected and sent as QC materials. PT results for most of the markers were in concordance, except those for FMC7 and CD64. CONCLUSIONS: For the QC control of flow cytometry without commercialized QC materials, cultured cell lines are useful and can be used as an alternative for management of reagents used in flow cytometric analysis.
Cell Line ; Cell Survival ; Cells, Cultured ; Flow Cytometry* ; Hematopoietic Stem Cells ; Immunophenotyping ; Indicators and Reagents ; Korea* ; Laboratory Proficiency Testing ; Lymphocyte Subsets ; Quality Control*

BACKGROUND: In general, internal/external quality control of special stains for diagnosis of hematological diseases may be unavailable in a clinical laboratory owing to the lack of an appropriate positive/negative control material. METHODS: We developed a protocol on positive/negative control materials for five special stains (iron, myeloperoxidase [MPO], periodic acid-Schiff [PAS], Sudan black B [SBB], and alpha-naphthyl acetate esterase [ANAE]) using a hematological malignant cell line. First, we compared stainability of seven cell lines (HL-60, THP-1, K562, Kasumi-1, KG-1, KO52, and NKM-1), then confirmed duration of stable stainability. A proficiency test using external quality control materials was conducted at eleven institutions, which participated voluntarily. RESULTS: HL-60 and THP-1 cell lines, which showed good stainability among the seven cancer cell lines, were selected as external quality control materials. The stainability of a prepared cell line fixed on control slides was stable for 3–4 weeks (MPO, SBB, and PAS) or 9–10 weeks (ANAE). The stainability of paraffin-embedded control material for iron stain was stable for 3 months. The results from 11 institutions were the same on iron, MPO, SBB, and ANAE. Nevertheless, two of 10 institutes showed discrepant results on PAS. CONCLUSIONS: In this study, we demonstrated that cell lines could serve as a standard quality control material for special stains. Most institutions showed representative results on special stains except for PAS. This protocol for special stain may be useful as an external or internal quality control in a haematology laboratory.
Academies and Institutes ; Cell Line ; Coloring Agents* ; Diagnosis ; Hematologic Diseases ; Hematology* ; Iron ; Laboratory Proficiency Testing ; Naphthol AS D Esterase ; Peroxidase ; Quality Control* ; Sudan