This report provides a summary of the 2024 survey results on the external quality assessment (EQA) scheme for the general transfusion medicine test and the general transfusion antibody test programs in Korea. Proficiency testing materials were prepared at the Asan Medical Center for bi-annual distribution to participating laboratories. The accuracy rates and number of participating laboratories for the bi-annual EQAs were: ABO typing, 99.6%–99.9% (n=944, n=945); RhD typing, 99.9%–100.0% (n=929, n=930);crossmatching, 95.0%–99.2% (n=825, n=825); unexpected antibody scre ening, 99.5%–100.0% (n=363, n=367); direct antiglobulin test (DAT) using a polyspecific reagent, 99.3%–100.0% (n=296, n=299); DAT using an antiimmunoglobulin G monospecific reagent, 100.0% (n=74, n=72); and DAT using an anti-C3d monospecific reagent, 98.6%–100.0% (n=72, n=71). The 2024 EQA scheme for the transfusion medicine program has improved and maintained the standards of the participating laboratories.

Background: The accuracy-based creatinine (ABCr) proficiency testing (PT) program by the Korean Association of External Quality Assessment Service evaluates bias and acceptability in participating laboratories using target values assigned by the primary reference measurement procedure (RMP). This study evaluated the impact of type A standard measurement uncertainty (MU) in the primary RMP on bias and acceptability assessments. Methods: ABCr PT data from 2020 to 2021 were analyzed. Using the target mean, standard deviation, and number of replicates provided by the Reference Material Institute for Clinical Chemistry Standards laboratory (Japan), the type A MU for each sample was calculated using a bottom-up approach. Bias and acceptability of creatinine assays were compared with and without the inclusion of type A MU when assigning target values. Results: The type A MU of the primary RMP for the creatinine assays ranged from 0.01 to 0.02 mg/dL depending on the sample. Without type A MU, the mean bias of creatinine assay ranged from −2.9% to 6.5%. Incorporating type A MU into target values, adjusted the mean bias to −3.2% to 5.3% (with addition) and −2.6% to 7.8% (with subtraction). Acceptability rates ranged from 69.2% to 95.0% without type A MU and shifted to 70.1% to 95.1% (with addition) and 68.5% to 95.4% (with subtraction). Conclusions The inclusion of type A MU in the primary RMP affects bias and acceptability assessment, highlighting its significance in the interpretation of ABCr PT results.

Background: Sanger sequencing is a technology used to identify the gene sequence variants causing rare genetic disorders. However, designing and implementing a proficiency scheme for Sanger sequencing-based genetic testing is challenging because many molecular diagnostic laboratories are running sequencing tests for tens to hundreds of target genes. As such, we aimed to design and implement a method-based proficiency testing (PT) method for Sanger sequencing and to assess its feasibility in Korea. Methods: A pathogenic low density lipoprotein receptor (LDLR) variant was chosen as the positive PT material, and material without an LDLR variant was used as the negative PT material. We distributed the two PT materials with primer pair sets to 17 molecular diagnostic laboratories nationwide.We calculated the correct results (%) for variation type, zygosity, nucleotide change, amino acid change, variant classification, and clinical interpretation. Results: Fourteen laboratories responded to the survey. The results for the two PT materials were 100% correct for all evaluation points including variant type, zygosity, nucleotide change, amino acid change, variant classification, and clinical interpretation. Conclusions This pilot PT survey demonstrates a feasibility of using method-based PT for assessing the Sanger sequencing performance of molecular diagnostic laboratories in Korea.

Background: Hemolysis is an important preanalytical factor that influences laboratory test results. Because arterial blood gas analysis (ABGA) is performed using whole blood, it is difficult to visually check whether a specimen is hemolyzed, and even blood gas analyzers cannot detect hemolysis. However, there is insufficient consensus on the parameters that are influenced by hemolyzed specimens. This study aimed to determine the effect of hemolysis on ABGA results. Methods: One hundred residual arterial blood specimens were collected from Severance Hospital between March and April 2022. Samples were aliquoted into three groups for mechanical hemolysis. Hemolysis was induced using 16-, 22-, and 26-gauge needles and measured using the Profile pHOx Ultra Blood Gas Analyzer (Nova Biomedical, USA). The remaining blood was centrifuged, and the hemolysis index was determined using the plasma. Results: Among the parameters, pH and K increased, whereas pCO 2 , Na,Ca 2+ , and HCO 3− decreased. The values of Hb, Mg2+ , and Hct did not change with the degree of hemolysis, although there was a difference between the two groups. The values of pCO 2 , Hb, K, and Ca 2+ increased as the degree of hemolysis increased, with % biases exceeding the desirable bias. Conclusions This study confirmed that hemolysis significantly influences pH, pCO 2 , and K. Therefore, when clinical findings and blood gas analysis results are inconsistent, clinicians should be cautious of spurious hemolysis when interpreting the results.

Background: This study established sex-specific reference intervals (RIs) for hematological parameters, including the monocyte distribution width (MDW), in Korean adults and assessed the need for separate RIs according to sex in older adults. Methods: Hematological parameters were measured using a DxH 900 hematology analyzer (Beckman Coulter, USA) on 328 peripheral blood samples from 124 men and 204 women aged 19–93 years. Results: The RIs for white blood cells, red blood cells (RBCs), Hb, Hct, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, monocyte percentage, and neutrophil, eosinophil, lympho­cyte, and monocyte counts differed significantly by sex (P<0.05). Mean corpuscular volume was significantly positively associated with age, whereas RBC and platelet counts were significantly negatively correlated with age in both men and women. Age-based analysis revealed significant shifts in the RBC parameters beginning at 60 years of age in men and 70 years of age in women. The MDW did not show significant differences according to sex or age. Conclusions This study supports the use of sex-specific RIs and highlights the importance of considering age when interpreting results regarding hematological parameters in clinical practice.

This report provides a summary of the 2024 survey results on the external quality assessment (EQA) scheme for the general transfusion medicine test and the general transfusion antibody test programs in Korea. Proficiency testing materials were prepared at the Asan Medical Center for bi-annual distribution to participating laboratories. The accuracy rates and number of participating laboratories for the bi-annual EQAs were: ABO typing, 99.6%–99.9% (n=944, n=945); RhD typing, 99.9%–100.0% (n=929, n=930);crossmatching, 95.0%–99.2% (n=825, n=825); unexpected antibody scre ening, 99.5%–100.0% (n=363, n=367); direct antiglobulin test (DAT) using a polyspecific reagent, 99.3%–100.0% (n=296, n=299); DAT using an antiimmunoglobulin G monospecific reagent, 100.0% (n=74, n=72); and DAT using an anti-C3d monospecific reagent, 98.6%–100.0% (n=72, n=71). The 2024 EQA scheme for the transfusion medicine program has improved and maintained the standards of the participating laboratories.

Background: The accuracy-based creatinine (ABCr) proficiency testing (PT) program by the Korean Association of External Quality Assessment Service evaluates bias and acceptability in participating laboratories using target values assigned by the primary reference measurement procedure (RMP). This study evaluated the impact of type A standard measurement uncertainty (MU) in the primary RMP on bias and acceptability assessments. Methods: ABCr PT data from 2020 to 2021 were analyzed. Using the target mean, standard deviation, and number of replicates provided by the Reference Material Institute for Clinical Chemistry Standards laboratory (Japan), the type A MU for each sample was calculated using a bottom-up approach. Bias and acceptability of creatinine assays were compared with and without the inclusion of type A MU when assigning target values. Results: The type A MU of the primary RMP for the creatinine assays ranged from 0.01 to 0.02 mg/dL depending on the sample. Without type A MU, the mean bias of creatinine assay ranged from −2.9% to 6.5%. Incorporating type A MU into target values, adjusted the mean bias to −3.2% to 5.3% (with addition) and −2.6% to 7.8% (with subtraction). Acceptability rates ranged from 69.2% to 95.0% without type A MU and shifted to 70.1% to 95.1% (with addition) and 68.5% to 95.4% (with subtraction). Conclusions The inclusion of type A MU in the primary RMP affects bias and acceptability assessment, highlighting its significance in the interpretation of ABCr PT results.

Background: Sanger sequencing is a technology used to identify the gene sequence variants causing rare genetic disorders. However, designing and implementing a proficiency scheme for Sanger sequencing-based genetic testing is challenging because many molecular diagnostic laboratories are running sequencing tests for tens to hundreds of target genes. As such, we aimed to design and implement a method-based proficiency testing (PT) method for Sanger sequencing and to assess its feasibility in Korea. Methods: A pathogenic low density lipoprotein receptor (LDLR) variant was chosen as the positive PT material, and material without an LDLR variant was used as the negative PT material. We distributed the two PT materials with primer pair sets to 17 molecular diagnostic laboratories nationwide.We calculated the correct results (%) for variation type, zygosity, nucleotide change, amino acid change, variant classification, and clinical interpretation. Results: Fourteen laboratories responded to the survey. The results for the two PT materials were 100% correct for all evaluation points including variant type, zygosity, nucleotide change, amino acid change, variant classification, and clinical interpretation. Conclusions This pilot PT survey demonstrates a feasibility of using method-based PT for assessing the Sanger sequencing performance of molecular diagnostic laboratories in Korea.

Background: Hemolysis is an important preanalytical factor that influences laboratory test results. Because arterial blood gas analysis (ABGA) is performed using whole blood, it is difficult to visually check whether a specimen is hemolyzed, and even blood gas analyzers cannot detect hemolysis. However, there is insufficient consensus on the parameters that are influenced by hemolyzed specimens. This study aimed to determine the effect of hemolysis on ABGA results. Methods: One hundred residual arterial blood specimens were collected from Severance Hospital between March and April 2022. Samples were aliquoted into three groups for mechanical hemolysis. Hemolysis was induced using 16-, 22-, and 26-gauge needles and measured using the Profile pHOx Ultra Blood Gas Analyzer (Nova Biomedical, USA). The remaining blood was centrifuged, and the hemolysis index was determined using the plasma. Results: Among the parameters, pH and K increased, whereas pCO 2 , Na,Ca 2+ , and HCO 3− decreased. The values of Hb, Mg2+ , and Hct did not change with the degree of hemolysis, although there was a difference between the two groups. The values of pCO 2 , Hb, K, and Ca 2+ increased as the degree of hemolysis increased, with % biases exceeding the desirable bias. Conclusions This study confirmed that hemolysis significantly influences pH, pCO 2 , and K. Therefore, when clinical findings and blood gas analysis results are inconsistent, clinicians should be cautious of spurious hemolysis when interpreting the results.

Background: This study established sex-specific reference intervals (RIs) for hematological parameters, including the monocyte distribution width (MDW), in Korean adults and assessed the need for separate RIs according to sex in older adults. Methods: Hematological parameters were measured using a DxH 900 hematology analyzer (Beckman Coulter, USA) on 328 peripheral blood samples from 124 men and 204 women aged 19–93 years. Results: The RIs for white blood cells, red blood cells (RBCs), Hb, Hct, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, monocyte percentage, and neutrophil, eosinophil, lympho­cyte, and monocyte counts differed significantly by sex (P<0.05). Mean corpuscular volume was significantly positively associated with age, whereas RBC and platelet counts were significantly negatively correlated with age in both men and women. Age-based analysis revealed significant shifts in the RBC parameters beginning at 60 years of age in men and 70 years of age in women. The MDW did not show significant differences according to sex or age. Conclusions This study supports the use of sex-specific RIs and highlights the importance of considering age when interpreting results regarding hematological parameters in clinical practice.