1.Scheme Design and Results Analysis of Ground Bond Proficiency Testing.
Tao CHEN ; Yichuan ZHANG ; Dawei LU ; Baosheng GUO ; Bingzhen WEI
Chinese Journal of Medical Instrumentation 2015;39(6):454-456
Grounding impedance measurement is a traditional proficiency testing programs, 2014 proficiency testing program on the basis of original ability to verify, combined with actual detection need, innovation introduced two verification point of the power input socket and metal plane testing. This paper analyzes and discusses the results of the ability verification in 2014, and puts forward the points of attention and the recommended method of metal plane test.
Laboratories
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standards
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Laboratory Proficiency Testing
2.External Quality Assessment of Institutions and Instruments Using a Linear Mixed Model.
Jinsook LIM ; Sungho WON ; Suyeon PARK ; Jimyung KIM ; Sun Hoe KOO ; Gye Choel KWON
Journal of Laboratory Medicine and Quality Assurance 2016;38(1):43-51
BACKGROUND: External quality assessment (EQA) uses a standard deviation index (SDI), based on a peer group, to evaluate laboratory performance. However, evaluations using peer group SDIs often have limited applicability, because they are not statistically valid unless the number of institutions in the same peer group is large. The present study proposes a statistical model for simultaneously evaluating the performance of all participating institutions, as well as the performance of instruments on the market. METHODS: By assuming that proficiency test results were affected by the manufacturer, the instrument, and the institution, the effects of those factors were estimated using a linear mixed model. We used these effect estimates to calculate manufacturer, instrument, and institution SDIs. Using simulation, we evaluated the false positive rates and efficiencies of the proposed linear mixed model. RESULTS: Simulations showed that the linear mixed model empirical type I error rates preserved the nominal significance level. This model was also more statistically efficient than the peer group SDI. Rates of unacceptability were lower when using institution SDI than they were when using peer group SDI. Additional outliers that could not be evaluated using the current system were detected by the institution SDI statistic. The instrument SDI statistic detected outliers among different instrument groups. CONCLUSIONS: Institution and instrument SDIs are robust and efficient tools for EQA, and they can replace the currently used system of peer group SDI.
Laboratory Proficiency Testing
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Models, Statistical
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Peer Group
3.Annual Report on the External Quality Assessment Scheme for Special Protein in Korea (2017).
Journal of Laboratory Medicine and Quality Assurance 2018;40(2):85-91
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
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Immunoassay
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Korea*
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Laboratory Proficiency Testing
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Quality Control
4.Annual Report on the External Quality Assessment Scheme for Hormones in Korea (2017).
Journal of Laboratory Medicine and Quality Assurance 2018;40(2):77-84
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
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Immunoassay
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Korea*
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Laboratory Proficiency Testing
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Quality Control
5.Report on the External Quality Assessment Scheme for Hemoglobin A1c in Korea (2016–2017).
Sun Hee JUN ; Kyunghoon LEE ; Junghan SONG
Journal of Laboratory Medicine and Quality Assurance 2018;40(4):178-181
As part of the clinical chemistry programs of the Korean Association of External Quality Assessment Service, we organized trials to conduct external quality assessment of hemoglobin A1c (HbA1c) in 2016 and 2017. We delivered three commutable whole blood specimens for each trial. The overall response rates were 96.4% in 2016 and 98.4% and 99.6% in the first and second trials in 2017, respectively. Two types of reports were generated: a common report including the mean, standard deviation, coefficient of variation, median, minimum value, and maximum value according to manufacturer and instrument, as well as a summary report of the results from each participating laboratory, including a histogram for each specimen, Levey-Jennings chart for serial percent deviations, and table showing the target value, upper and lower limits, percent deviation, and grade. From 2016, the acceptance criterion was changed from ±8.0% to ±6.7%. The overall acceptable rates for the survey were 91.5%, 91.4%, 94.9%, and 89.0% for the first trial in 2016 through the second trial in 2017, respectively. The requisite continual improvement in the quality of HbA1c testing can be achieved through participation in similar accuracy-based proficiency testing programs.
Chemistry, Clinical
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Korea*
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Laboratory Proficiency Testing
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Research Report
6.Study on Proficiency Testing of Determination Potassium in Serum.
Ting YU ; Liying MA ; Juanli ZHANG ; Shoufang QU ; Nan SUN ; Jing SUN ; Lili LI ; Xinhua XIANG
Chinese Journal of Medical Instrumentation 2021;45(2):219-223
OBJECTIVE:
To evaluate the capacity of laboratories participated in the proficiency testing (PT) of determination potassium in serum and improve the quality of testing, and put forward technical suggestions for unsatisfied laboratories.
METHODS:
According to the requirements of CNAS related documents, the homogeneity and stability of the real PT sample were evaluated by one-way ANOVA and t test, respectively. The values of real PT samples were assigned by reference method which was used in PT results assay. It is required that the deviation of value of real PT samples (code:2, 3, 5) between the measured value and the assigned value shall be within ±15.0%. The precision of values for all samples should not be greater than 3.0%.
RESULTS:
All the laboratories submitted valid data according to the requirements. Only one laboratory did not meet the requirements, and the satisfaction rate was 90.9%.
CONCLUSIONS
The ability of most of laboratories are accurate and reliable.
Drinking Water/analysis*
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Laboratories
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Laboratory Proficiency Testing
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Potassium
7.Annual Report on the External Quality Assessment Scheme for Immunohematology Testing in Korea (2016).
Journal of Laboratory Medicine and Quality Assurance 2017;39(3):107-116
We report here the 2016 results of surveys on an external quality assessment (EQA) for immunohematology testing in Korea carried out in 2016. The proficiency testing specimens were prepared at Ajou University Hospital, and the specimens were sent to participants biannually. The average accuracy rates (N=the number of participants) for ten different test items on the regular survey were as follows: ABO typing, 98.9%–99.7% (N=627); RhD typing, 98.6%–99.8% (N=607); crossmatching, 90.1%–98.1% (N=454); ABO subtyping, 92.7%–93.0% (N=42); Rh CcEe antigen testing, 97.8%–100.0% (N=46); weak D test, 70.8%–73.6% (N=91); antibody screening, 96.6%–100.0% (N=267); direct antiglobulin test (DAT) using a polyspecific reagent, 92.2%–99.6% (N=49); DAT using an immunoglobulin G monospecific reagent, 84.1%–100.0% (N=68); DAT using a C3d monospecific reagent, 80.0%–100.0% (N=68); antibody identification, 96.7%–99.1% (N=118); and ABO antibody titration, 82.4%–100.0% (N=42). Excellent results for the 2016 EQA for immunohematology testing were obtained, except for those of the weak D test. The EQA for immunohematology testing in 2016 should be helpful for improving the quality of participating laboratories.
Coombs Test
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Immunoglobulin G
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Korea*
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Laboratory Proficiency Testing
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Mass Screening
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Transfusion Medicine
8.Annual Report on the External Quality Assessment Scheme for Blood Blank Tests in Korea (2014).
Young Ae LIM ; Jin Sook OH ; Seog Woon KWON ; Kye Chul KWON ; Shin Young KIM ; Kyung Un PARK ; Hyun Jun PARK ; Woon Heung SONG ; Duck CHO ; Tae Hyoun UM ; Mi Kyoung LEE ; Sang Moo HAN
Journal of Laboratory Medicine and Quality Assurance 2015;37(2):47-55
We report here the results of surveys on external quality assessment (EQA) of blood bank tests in Korea carried out in 2014. The proficiency testing specimens were prepared at Ajou University Hospital and the response rates for the 1st and 2nd trials were 94.3% (537/549) and 96.0% (545/554), respectively. No answers were considered incorrect, and the average accuracy rates of six different test items on the regular survey were as follows: ABO grouping, 98.5% to 100.0%; RhD typing, 98.1% to 99.4%; crossmatching, 91.2% to 99.6%; direct antiglobulin test (DAT) using a polyspecific reagent, 96.7% to 98.4%; DAT using an immunoglobulin-G monospecific reagent, 93.8% to 98.7%; DAT using a C3d monospecific reagent, 89.5% to 98.7%; unexpected antibody screening test, 96.2% to 100.0%; and antibody identification test, 69.8% to 100.0%. Test items for the pilot survey were reactivities to anti-A1 and anti-H, Rh subgrouping, and ABO antibody titration. Except for the result of the antibody identification test for specimens with multiple antibodies, we obtained excellent survey results for the EQA of blood bank tests carried out in 2014. In addition, the number of participating institutes was higher in 2014 than in 2013. The EQA of blood bank tests in 2014 should be helpful for improving the quality of the participating laboratories.
Academies and Institutes
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Antibodies
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Blood Banks
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Coombs Test
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Korea
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Laboratory Proficiency Testing
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Mass Screening
9.Annual Report on External Quality Assessment of Blood Bank Tests in Korea (2013).
Young Ae LIM ; Jin Sook OH ; Seog Woon KWON ; Kye Chul KWON ; Shin Young KIM ; Kyung Un PARK ; Hyun Jun PARK ; Woon Heung SONG ; Duck CHO ; Tae Hyoun UM ; Kwang HUR ; Sang Moo HAN
Journal of Laboratory Medicine and Quality Assurance 2014;36(2):55-63
We report here the results of surveys for External Quality Assessment (EQA) of blood bank tests carried out in 2013. The proficiency testing specimens were prepared at Ajou University Hospital and sent to 548 and 545 institutes participating in the 1st and 2nd trial, respectively. Test items for the surveys were ABO grouping, RhD typing, crossmatching, direct antiglobulin test (DAT), antibody screening test, and antibody identification test. The response rates for the 1st and 2nd trials were 94.3% and 96.0%, respectively. No answers were considered incorrect answers, and the average accuracy rates of different test items of the survey were as follows: ABO grouping, 98.9% to 100%; RhD typing, 98.4% to 99.2%; crossmatching, 94.4% to 100.0%; DAT using polyspecific reagent, 94.5% to 99.7%; DAT using IgG monospecific reagent, 94.7% to 98.8%; DAT using C3d monospecific reagent, 91.3% to 98.6%; unexpected antibody screening test, 90.9% to 100%; and antibody identification test, 87.3% to 100.0%. Overall, we obtained excellent survey results for the EQA of blood bank tests carried out in 2013, and the number of participating institutes was higher in 2013 than in 2012.
Academies and Institutes
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Blood Banks*
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Coombs Test
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Immunoglobulin G
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Korea
;
Laboratory Proficiency Testing
;
Mass Screening
10.Annual Report on the External Quality Assessment Scheme for Blood Bank Tests in Korea (2015).
Young Ae LIM ; Hyun Soo CHO ; Seog Woon KWON ; Kye Chul KWON ; Shin Young KIM ; Kyung Un PARK ; Hyun Jun PARK ; Woon Heung SONG ; Duck CHO ; Tae Hyoun UM ; Mee Kyung LEE ; Sang Moo HAN
Journal of Laboratory Medicine and Quality Assurance 2016;38(2):59-67
We report here the results of the external quality assessment scheme (EQA) of blood bank tests in Korea carried out in 2015. The proficiency testing specimens used in the survey were prepared at Ajou University Hospital. The response rates from participating laboratories for the first and second trials were 98.7% (542/549) and 98.2% (544/554), respectively. No answers to tests were considered incorrect, and the average accuracy rates for six different test items on the standard survey were as follows: ABO grouping, 99.4% to 100.0%; RhD typing, 99.4% to 100.0%; crossmatching, 93.6% to 99.0%; direct antiglobulin test (DAT) using a polyspecific reagent, 92.9% to 98.3%; DAT using an IgG monospecific reagent, 94.6% to 100.0%; DAT using a C3d monospecific reagent, 84.2% to 98.6%; unexpected antibody screening test, 94.5% to 100.0%; and antibody identification test, 93.8% to 100.0%. We performed a pilot survey on reactivities to A1 (54 responses) and H (50 responses); Rh C, c, E, and e antigen testing (47 responses); and ABO antibody titration (10-34 responses). We obtained excellent results for this EQA, and these results will be helpful for improving or maintaining the quality of the participating laboratories.
Blood Banks*
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Coombs Test
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Immunoglobulin G
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Korea*
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Laboratory Proficiency Testing
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Mass Screening