The journey of Malaysian external quality assurance program for general diagnostic histopathology

@#International Academy of Pathology, Malaysian Division has initiated and run the external quality assurance program for general diagnostic histopathology since the year 2017. This article introduces the educational philosophy of this external quality assurance program and the technicalities in running such a national program. Challenges in ensuring the successful running of this program to gain wide acceptance by histopathology laboratories in Malaysia as well as experience in overcoming these challenges are detailed. This article charts the future direction of this external quality assurance program.

Report on the External Quality Assessment Scheme for Cytogenetics and Molecular Cytogenetics in Korea (2016–2017)

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.

ЭС СУДЛАЛЫН ШИНЖИЛГЭЭНИЙ ЧАНАРЫН ГАДААД ХЯНАЛТЫН АСУУДАЛД / Шинэ санаа Шинэ нээлт

@#BACKGROUND. Uterine cervical cancer is the fourth leading cause of cancer deaths in women worldwide. In our country, cervical cancer is second most common cancer in women. Uterine cervical smear (Papanicolaou test) remains an effective and widely used method for early detection of precancerous and cancerous lesions. Since 2002, the cervical smear was introduced to the clinical practice of our country. However, there is no study to performed external quality assurance of cervical smear until now. MATERIALS AND METHODS. We selected 20 glass slides of uterine cervical smear, the diagnosis was approved by histopathology. Each chosen slides were evaluated by four cytologists of A, B, C, D hospitals with hidden clinical information, independently. RESULTS. The sensitivity of A, B, C and D hospitals were 87.5%, 93.3%, 93.3%, and 93.3%, respectively. The specificity of A, B, C and D hospitals was 85.7%, 85.7%, 75%, and 66.6%, respectively. The diagnostic concordance of A, B, C and D was 70%, 75%, 50%, and 55%, respectively. The agreement of cytological diagnosis was moderate (kappa = 0.55), moderate (kappa = 0.43), fair (kappa = 0.37), and fair (kappa = 0.33) in A, B, C, and D hospitals, respectively. CONCLUSION: The external quality assurance in cytopathology is needed in Mongolia. The diagnostic concordance method would be applicable in our country to improve diagnostic agreement.

How better is random blinded re‑checking results in Revised National TB Control Programme, India.

Background: The Revised National Tuberculosis Control Programme (RNTCP) is implementing the External Quality assurance (EQA) and Random blinded re-checking (RBRC) as one of its important component. This nationwide study was conducted to determine (1) the number and types of RBRC errors and (2) the sensitivity and specificity among rechecked slides. Materials and Methods: The study was based on the monthly RBRC reports submitted by ~13,000 designated microscopy centres (DMCs) across the country under routine programmatic settings in 2010. The DMCs reports were compiled at district, state and national level. Results: A total of 11, 89,564 slides were rechecked from 11,039 DMCs. Of which 99.5% of rechecked slides did not have any errors. The sensitivity and specificity of the rechecked slides had 98% sensitivity and 100% specificity. Conclusion: RBRC is the crucial component of EQA and the results from the programme are found to be satisfactory. Based on the study findings, the earlier value of 80% sensitivity used for calculation of annual sample size for RBRC has been increased to 90% sensitivity. The annual RBRC sample size for DMCs has been increased by 1.5–2 folds.

Annual Report on External Quality Assessment in Clinical Chemistry in Korea (2009) / 임상검사와정도관리

Six trials with 3 samples for each trial for external quality assessment of general chemistry and blood gas were performed in 2009. All the control materials were sent in specifically-made boxes at the same time. The response rates were 87.5% in general chemistry and 89.3% in blood gas. The items included sodium, potassium, chloride, BUN, glucose, calcium, phosphorus, uric acid, creatinine, bilirubin, total protein, albumin, total cholesterol, triglyceride, AST, ALT, ALP, LD and GGT in general chemistry and pH, pCO2 and pO2 in blood gas. Compared with the previous year (2008), change of the methods of analysis was not remarkable. The peer group coefficient of variation and the VIS scores of general chemistry items were slightly improved.

Annual Report on External Quality Assessment in Diagnostic Genetics in Korea (2009) / 임상검사와정도관리

BACKGROUND: The quality control for genetic tests would be of great importance as the test volume and clinical demands increase dramatically. Diagnostic genetics subcommittee of KSQACL performed two trials for cytogenetics and molecular genetics surveys in 2009. METHODS: A total of 67 laboratories participated in the cytogenetic surveys, 30 laboratories participated in the FISH surveys, and 94 laboratories participated in the molsecular genetics surveys in 2009. RESULTS: Almost of them showed acceptable results. However, some laboratories showed unacceptable results for the karyotype nomenclature and detection of complex cytogenetic abnormalities in hematologic neoplasms, and most of them except one showed acceptable results in FISH surveys. The molecular genetics surveys included various tests: M. tuberculosis detection, hepatitis B (HBV) and C virus (HCV) detection and quantification, human papilloma virus (HPV) genotyping, Influenza A (H1N1) detection, gene rearrangement tests for leukemias and lymphomas, apolipoprotein E (APOE) genotyping, methylenetetrahydrofolate reductase (MTHFR) genotyping, hereditary breast and ovarian cancer genes (BRCA1 and BRCA2), and genetic tests for achondroplasia (FGFR3), FMS-like tyrosine kinase 3 (FLT3), JAK2, BRAF, hereditary disorders such as spinal muscular atrophy, Huntington disease (HD), spinocerebellar ataxia (SCA), Prader-Willi/Angelman syndrome (PWS/AS), mitochondrial encephalopathy with lactic acidosis and strokelike episodes (MELAS), myoclonic epilepsy ragged red fiber (MERRF), wilson disease (ATP7B) and cancer-associated genes (KRAS). Molecular genetic surveys showed excellent results in most of the participants. CONCLUSIONS: External quality assessment program for genetic analysis in 2009 was proved to be helpful in continuous education and evaluation of quality improvement.

Annual Report on External Quality Assessment in Clinical Chemistry in Korea (2008) / 임상검사와정도관리

Six trials with 3 samples for each trial for external quality assessment of general chemistry and blood gas were performed in 2008. All the control materials were sent in specifically-made boxes at the same time. The response rates were 93.5% in general chemistry and 88.1% in blood gas. The items included sodium, potassium, chloride, BUN, glucose, calcium, phosphorus, uric acid, creatinine, bilirubin, total protein, albumin, total cholesterol, triglyceride, AST, ALT, ALP, LD and GGT in general chemistry and pH, pCO2 and pO2 in blood gas. Compared with the previous year (2007), change of the methods of analysis and the peer group coefficient of variation was not remarkable and the VIS scores of general chemistry items were slightly improved.

Annual Report on External Quality Assessment in Diagnostic Genetics in Korea (2008) / 임상검사와정도관리

The quality control for genetic tests would be of great importance as the test volume and clinical demands increase dramatically. Diagnostic genetics subcommitee of KSQACP performed two trials for cytogenetic study in 2008. A total of 41 laboratories participated in the cytogenetic surveys, and most of them showed acceptable results. However, some laboratories showed unacceptable results for the karyotype nomenclature and detection of complex cytogenetic abnormalities in hematologic neoplasias. The molecular genetics surveys included various tests: M. tuberculosis detection, hepatitis B (HBV) and C virus (HCV) detection and quantification, human papilloma virus (HPV) genotyping, gene rearrangement tests for leukemias and lymphomas, apolipoprotein E (APOE) genotyping, methylenetetrahydrofolate reductase (MTHFR) genotyping, hereditary breast and ovarian cancer genes (BRCA1 and BRCA2), and genetic tests for hereditary disorders such as spinal muscular atrophy (SMA), Huntington disease (HD), spinocerebellar ataxia (SCA), Prader-Willi/Angelman syndrome (PWS/AS), mitochondrial encephalopathy with lactic acidosis and strokelike episodes (MELAS), myoclonic epilepsy ragged red fiber (MERRF), wilson disease (ATP7B) and cancer-associated genes (KRAS). Molecular genetic surveys showed excellent results in most of the participants. External quality assessment program for genetic analysis in 2008 was proved to be helpful in continuous education and evaluation of quality improvement.

The Current Status of HIV Serologic Testing in Korean Clinical Laboratories during the Year 2007 / 대한수혈학회지

BACKGROUND: HIV serologic testing is essential for blood donor screening, and the test results should be accurate. It is important that clinical laboratories perform quality control, quality management and standardization for obtaining accurate laboratory results. The Korean National Institute of Health, the Division of AIDS and the Center for Immunology and Pathology have all performed annual external quality surveillance assessment (EQS, EQA) with using a 5 sera panel for all the Korean HIV testing laboratories that have collaborated with the Quality Assurance Committee of the Korean Society of Laboratory Medicine since 2005. The results of HIV testing in the clinical laboratories during the year 2007 were analyzed. METHODS: The results for the clinical laboratories that participated in the HIV EQAS during 2007 were collected and analyzed. The HIV test results and questionnaire data were sent to the web site "http://hivqa.nih.go.kr". Three hundred thirty two results from 303 institutions in 2007 were analyzed. RESULTS: The most widely used HIV testing method was an automated chemiluminescent immunoassay, such as the Abbott AxSym and the Architect system or the Roche Elecsys. About 5% of erroneous results were reported among 332 results. The causes of error were mostly clerical errors and specimen errors. CONCLUSION: The current status for HIV testing in Korean clinical laboratories was that fully automated immunoassay analyzers were used along with manual POCT tests.

Annual Report on External Quality Assessment in Clinical Chemistry in Korea (2007) / 임상검사와정도관리

Six trials with 3 samples for each of external quality assessment for general chemistry and blood gas were performed in 2007. All the control materials were sent in specifically-made boxes at the same time. The response rates were 92.0% in general chemistry and 95.5% in blood gas. The items included sodium, potassium, chloride, BUN, glucose, calcium, phosphorus, uric acid, creatinine, bilirubin, total protein, albumin, total cholesterol, triglyceride, AST, ALT, ALP, LD and GGT in general chemistry and pH, pCO2 and pO2 in blood gas. Compared with the previous year (2006), the methods of analysis were slightly changed and the coefficient of variation and VIS scores of general chemistry items were not significantly changed.

Annual Report on External Quality Assessment in Diagnostic Genetics in Korea (2007) / 임상검사와정도관리

The importance of quality control for dramatically growing genetic tests continues to be emphasized with increasing clinical demands. Diagnostic genetics subcommitee of KSQACP performed two trials for cytogenetic study in 2007. Cytogenetic surveys were performed by 42 laboratories and answered correctly in most laboratories except some problems in karyotype nomenclature and the detection of complex cytogenetic abnormalities in hematologic neoplasias. The molecular genetics surveys included many kinds of tests: M. tuberculosis detection, hepatitis B (HBV) and C virus (HCV) detection and quantification, human papilloma virus (HPV) genotyping, gene rearrangement tests for leukemias and lymphomas, apolipoprotein E (APOE) genotyping, methylenetetrahydrofolate reductase (MTHFR) genotyping, hereditary breast and ovarian cancer genes (BRCA1 and BRCA2), and genetic tests for hereditary conditions such as Duchenne muscular dystrophy (DMD), Huntington disease, spinocerebellar ataxia, spinal muscular atrophy, and Prader-Willi/Angelman syndrome. Molecular genetic surveys showed excellent results in most of participants. External quality assessment program for genetic analysis in 2007 was proved to be helpful in continuous education and evaluation of quality improvement.

Annual Report on External Quality Assessment in Diagnostic Genetics in Korea (2007) / 임상검사와정도관리

The importance of quality control for dramatically growing genetic tests continues to be emphasized with increasing clinical demands. Diagnostic genetics subcommitee of KSQACP performed two trials for cytogenetic study in 2007. Cytogenetic surveys were performed by 42 laboratories and answered correctly in most laboratories except some problems in karyotype nomenclature and the detection of complex cytogenetic abnormalities in hematologic neoplasias. The molecular genetics surveys included many kinds of tests: M. tuberculosis detection, hepatitis B (HBV) and C virus (HCV) detection and quantification, human papilloma virus (HPV) genotyping, gene rearrangement tests for leukemias and lymphomas, apolipoprotein E (APOE) genotyping, methylenetetrahydrofolate reductase (MTHFR) genotyping, hereditary breast and ovarian cancer genes (BRCA1 and BRCA2), and genetic tests for hereditary conditions such as Duchenne muscular dystrophy (DMD), Huntington disease, spinocerebellar ataxia, spinal muscular atrophy, and Prader-Willi/Angelman syndrome. Molecular genetic surveys showed excellent results in most of participants. External quality assessment program for genetic analysis in 2007 was proved to be helpful in continuous education and evaluation of quality improvement.

Annual Report on External Quality Assessment in Inborn Error of Metabolism in Korea (2005) / 임상검사와정도관리

The trial of external quality assessment for inborn error of metabolism was performed in 2005. Total 11 specimens for the conventional newborn screening tests were distributed to 47 laboratories. The response rates were 92.5% (37/40) and 100% (47/47), in each trial. All the control materials were sent as filter paper forms. Each laboratory replied the test results of the screening items that they were doing as a routine test at the reception of the specimen among PKU screening, TSH, T4 (total/free), galactosemia screen, maple syrup urine disease screen, homocystinuria screen and histidinemia screen. The mean, SD, CV, median and range were analyzed. The pilot proficiency test for newborn screening using tandem mass spectrometry (MS/MS) was also performed. Total 8 blood spots were distributed to 9 laboratories performing newborn screening using MS/MS. Participants' results for amino acids & acylcarnitine and their cutoff values were analyzed.

Annual Report on External Quality Assessment in Clinical Chemistry in Korea (2004) / 임상검사와정도관리

Ten trials of external quality assessment for Clinical Chemistry in general chemistry and blood gas were performed in 2004. All the control materials were sent in specifically-made boxes at the same time. The response rates were 92.0% in general chemistry and 86.0% in blood gas. The items included sodium, potassium, chloride, BUN, glucose, calcium, phosphorus, uric acid, creatinine, bilirubin, total protein, albumin, total cholesterol, triglyceride, AST, ALT, ALP, LD and GGT in general chemistry and pH, pCO2 and pO2 in blood gas. Compared with the previous year (2003), the methods of analysis are not changed much and the coefficient of variation and VIS scores of general chemistry items are decreased.

Annual Report on External Quality Assessment in Inborn Error of Metabolism in Korea (2004) / 임상검사와정도관리

The trial of external quality assessment for inborn error of metabolism was performed twice in 2004. Total 10 specimens for the conventional newborn screening tests were distributed to 43 laboratories. The response rates were 90.7%(39/43) in first trial and 90%(36/40) in second trial. All the control materials were sent as filter paper forms. Each laboratory replied the test results as the screening items they were doing as a routine test at the reception of the specimen among PKU screening, TSH, T4 (total/free), galactosemia screen, maple syrup urine disease screen, homocytinuria screen and histidinemia screen. The mean, SD, CV, median and range were analyzed. From this trial, pilot proficiency test for newborn screening using tandem mass spectrometry (MS/MS) was also performed. Total 8 blood spots were distributed to 7 laboratories performing newborn screening using MS/MS. Participants results for amino acids & acylcarnitine and their cutoff values were analyzed.

Annual Report on External Quality Assessment in Diagnostic Genetics in Korea (2004) / 임상검사와정도관리

The importance of quality control for dramatically growing genetic tests continues to be emphasized with increasing clinical demands. Diagnostic genetics subcommitee of KSQACP performed two trials for cytogenetic study in 2004. Cytogenetic surveys were performed by 36 laboratories and answered correctly in most laboratories except some problems in karyotype nomenclature, interpretation of FISH test results and the detection of complex cytogenetic abnormalities in hematologic neoplasias. The molecular genetic test surveys included may kinds of tests like M. tuberculosis, HBV, HCV, HPV, leukemias/lymphomas, ApoE genotyping, MTHFR genotyping, BRCA1 & BRCA2, Duchenne muscular dystrophy, and Huntington disease. Each molecular test for HCV, MTHFR genotyping, BRCA1 & BRCA2 analysis and Huntington disease was the first challenge in 2004. Molecular genetic surveys showed excellent results in most of participants. External quality assessment program for genetic analysis in 2004 was proved to be helpful in continuous education and evaluation of quality improvement.

Annual Report on External Quality Assessment in Clinical Chemistry in Korea (2003) / 임상검사와정도관리

Ten trials of external quality assessment for Clinical Chemistry in general chemistry and blood gas were performed in 2003. All the control materials were sent in specifically-made boxes at the same time. The response rates were 90.3% in general chemistry and 91.8% in blood gas. The items included sodium, potassium, chloride, BUN, glucose, calcium, phosphorus, uric acid, creatinine, bilirubin, total protein, albumin, total cholesterol, triglyceride, AST, ALT, ALP, LD and GGT in general chemistry and pH, pCO2 and pO2 in blood gas. Compared with the previous year (2002), the methods of analysis are not changed much and the coefficient of variation and VIS scores of general chemistry items are decreased.

Annual Report on External Quality Assessment of Clinical Microbiology Laboratory in Korea (2003) / 임상검사와정도관리

Three trials of external quality assessment for clinical microbiology laboratory and two workshops were performed in 2003. A total of 19 specimens were distributed. Six specimens were distributed to 241 laboratories with 231 returns in Trial I, Five specimens to 241 laboratories with 225 returns in Trial II, and seven specimens to 245 laboratories with 220 returns in Trial III. The percentages of fully correct results of E. coli, E. faecalis, S. aureus, P. aeruginosa, K. pneumoniae, Candida albicans, P. aeruginosa, S. aureus, E. faecalis, K. pneumoniae, E. coli, and Candida tropicalis were 99%, 83%, 99%, 89%, 97%, 92%, 90%, 98%, 83%, 90%, 99%, and 63%, respectively. The standard deviation (SD) of inhibition zone diameter against each antibiotic was calculated. The within-one-SD percentages on disk diffusion test against ciprofloxacin, imipenem, ampicillin, cefotaxime, and cephalothin of E. coli (M0301) were 86%, 78%, 86%, 91%, and 76%, respectively. Those against vancomycin and teicoplanin of E. faecalis (M0302) were 77% and 95%, respectively. Those against vancomycin, oxacillin, penicillin G, clindamycin, erythromycin, ciprofloxacin, gentamicin and teicoplanin of S. aureus (M0303) were 82%, 80%, 81%, 81%, 79%, 80%, 88%, and 90%, respectively. Those against ciprofloxacin, gentamicin, imipenem, ceftazidime, and piperacillin of P. aeruginosa (M0304) were 73%, 88%, 85%, 83%, and 78%, respectively. Those against ciprofloxacin, imipenem, ampicillin, cefotaxime, and cephalothin of K. pneumoniae (M0305) were 89%, 89%, 87%, 81% and 86%, respectively. Thirty-five laboratories on Trial I and Trial II had reported the both results of disk diffusion and MIC methods. Seven laboratories use disk diffusion method or MIC method according to the bacterial species. The performance on the automated or E-test susceptibility tests was generally good. In conclusion, it is necessary that the quality assurance of the individual laboratories should be improved in the identification of Candida tropicalis and Enterococcus spp., and in susceptibility tests against oxacillin, erythromycin and ciprofloxacin of S. aureus, and cephalothin and imipenem of E. coli and vancomycin of E. faecalis in case of disk diffusion method.

Annual Report on External Quality Assessment in Inborn Error of Metabolism in Korea (2003) / 임상검사와정도관리

The trial of external quality assessment for inborn error of metabolism was performed in 2003. A total 10 specimens for neonatal screening tests were distributed to 43 laboratories with a response rate of 83%. All the control materials were sent as a filter paper form. Each laboratory replied the test result as the screening items they were doing as a rountine test at the reception of the specimen among PKU screening, neonatal TSH, neonatal T4(total/free), galactosemia screen, homocytinuria screen and histidinemia screen. The mean, SD, and CV were analyzed.

Annual Report on External Quality Assessment in Diagnostic Genetics in Korea (2003) / 임상검사와정도관리

The importance of quality control for dramatically growing genetic tests continues to be emphasized with increasing clinical demands. Diagnostic genetics subcommitee of KSQACP performed two trials for cytogenetic study in 2003. Cytogenetic surveys were performed by 33 laboratories and answered correctly in most laboratories except some problems in nomenclature and analysis for FISH and complex cytogenetic abnormalities in neoplasia. The molecular genetic test surveys include M. tuberculosis, HBV, HPV, leukemia/lymphoma, ApoE genotyping, Duchenne muscular dystrophy, myoclonic epilepsy and ragged red muscle fibers, and spinal and bulbar muscular atrophy. HPV, myoclonic epilepsy and ragged red muscle fibers, and spinal and bulbar muscular atrophy were the first challenge of the genetic survey. Molecular genetic survey showed excellent results in most participants, however, HPV tests should be improved by quality control in a few laboratories. External quality assessment program for cytogenetic analysis could be helpful to give participants many chances of continuous education and of interesting case materials.