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【Objective】 To evaluate the laboratory's NAT ability by analyzing the feedback reports of nucleic acid test (NAT) results of external quality assessment (EQA) of National Center for Clinic Laboratories (NCCL), so as to improve the laboratory management details and ensure blood safety. 【Methods】 The data of NCCL NAT EQA of blood screening laboratory of Tianjin Blood Center (a total of five occasions from Jan 2019 to Jun 2021) were statistically analyzed. 【Results】 From Jan 2019 to Jun 2021, the laboratory participated in EQA for five times and all the results were qualified. The test results of NAT EQA HIV RNA/HCV RNA/HBV DNA detected by R1, R2 and R4 were consistent with the reference results. R3 showed false positive results (CT value 40.46) in the single donation detection of sample No.1925 in HCV RNA. Unreported data of the laboratory was that in the first EQA in 2021, the R4 showed false positive results (CT value 35.8) in in the single donation detection of sample No.2113 in HIV RNA. 【Conclusion】 The performance of each NAT screening system in our laboratory is relatively stable except occasional false positive results influenced by every factor. Potential problems can be found and continuously improved by assaying EQA reports and the extended experimental results of EQA samples to further improve the detection ability.
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Aim: External Quality Assurance (EQA) is basic requirement of a medical laboratory to assess the quality assurance and achieve the accreditation. The available EQA schemes evaluate the analytical performances of the laboratory but neither evaluate pre analytical factors nor mimic actual laboratory process. PRE-EQC has combined both performances in single scheme and assisting the participant laboratories to take appropriate corrective action and interpretations.Design:Pre-Analytical monitoring evaluates transport condition, correlation of the stability of samples and temperature, storage condition and environment of the laboratory of the participants and its effect on the results. A sample is specially preparedto estimate haemolysis, lipemic and icteric index.Clinical Biochemistry:Serum, fluoride and biological fluid (CSF exempted) samples are pooled from the routine collection of specimens. Pooled fractions are homogenized in a rotary shaker for 10 minutes. The clear samples are poured in individual double pack primary containers, which are placed between two gel packs in a “biohazard” labelled plastic bag. Temperature is recorded, kept in insulated thermocol box and sent to the destination.Urine Routine & Microalbumin, Creatinine Examination:Urine sample is stabilized using preservative.
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OBJECTIVE: To conduct an external quality assessment (EQA) of dengue and chikungunya diagnostics among national-level public health laboratories in the Asia Pacific region following the first round of EQA for dengue diagnostics in 2013. METHODS: Twenty-four national-level public health laboratories performed routine diagnostic assays on a proficiency testing panel consisting of two modules. Module A contained serum samples spiked with cultured dengue virus (DENV) or chikungunya virus (CHIKV) for the detection of nucleic acid and DENV non-structural protein 1 (NS1) antigen. Module B contained human serum samples for the detection of anti-DENV antibodies. RESULTS: Among 20 laboratories testing Module A, 17 (85%) correctly detected DENV RNA by reverse transcription polymerase chain reaction (RT-PCR), 18 (90%) correctly determined serotype and 19 (95%) correctly identified CHIKV by RT-PCR. Ten of 15 (66.7%) laboratories performing NS1 antigen assays obtained the correct results. In Module B, 18/23 (78.3%) and 20/20 (100%) of laboratories correctly detected anti-DENV IgM and IgG, respectively. Detection of acute/recent DENV infection by both molecular (RT-PCR) and serological methods (IgM) was available in 19/24 (79.2%) participating laboratories. DISCUSSION: Accurate laboratory testing is a critical component of dengue and chikungunya surveillance and control. This second round of EQA reveals good proficiency in molecular and serological diagnostics of these diseases in the Asia Pacific region. Further comprehensive diagnostic testing, including testing for Zika virus, should comprise future iterations of the EQA.
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Objective To analyse the problems presented in external quality assessment (EQA)for blood cytomorphology and propose measures for improvement.Methods Statistical analysis was performed on EQA results for blood cytomorphology from 2011 to 2013 in Shaanxi Province,including general information of participant laboratories,coincident rate,and reported incorrect results.EQA for blood cytomorphology was held two times every year in Shaanxi province,with ten pictures inclu-ding bone marrow and peripheral blood smear each time.The compact disc including twenty pictures was given to partici-pants by EMS.Participants reported two EQA results in April and September each year.The center statisticed the EQA re-sults and provided the EQA reports to every participants in June and November.Results Participating laboratories increased from 76 in 2011 to 163 in 2013.The ratio of laboratories with the coincidence rate≥80% was 80%,47%,44%,55%,77%and 96% respectively.The number for single cell with the coincidence rate≥80% was 38.The coincidence rate of peripheral blood cells was higher than that of the bone marrow on the whole.Causes of incorrect results included cell lines’misclassifi-cation,growth stage’s misclassification,insufficient identification of abnormal cytomorphology,and so on.Conclusion The identification of blood cytomorphology was unbalanced in different leveled hospitals in Shaanxi Province.To develop EQA of blood cytomorphology definitely has a positive role in improving the experimenters’skill of identifying cytomorphology.
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Objecu've: On-site evaluation of laboratories with standard checklist is a first step to promote effective and consistent supervision. The present study was carried out to evaluate the impact of the RNTCP- Intermediate Reference Laboratory External Quality Assessment- On-Site Evaluation visits on quality of sputum smear microscopy services of Gujarat, India. Data of three IRL-EQA-OSE visit rounds, carried out between January 2005 and December 2010 are presented here. Materiaf and Methods: Within the Revised National Tuberculosis Control Programme EQA framework, the IRL, Ahmedabad visited all Gujarat District Tuberculosis Centres, and evaluated their sputum smear microscopy services. The study covered a cohort of 29 DTCs during each of the three IRL-EQA-OSE visits. The authors focused on section III of Annexure A to study and analyse the said impact. In order to convert qualitative data into quantitative one, the authors denoted a score of 1 to "Acceptable" (No Error) remark and 0 to "Not-Acceptable" (Error) one. Results.' Alarger degree of improvement was noted in Standard Operating Procedure practices, Disinfection practices, and Internal Quality Control practices. Many DTCs did not retrain their laboratory staff in EQA methodology. The Gujarat DTCs achieved an overall score of (8201957) 86% during the initial OSE visits which consistently improved to (842/957) 88% and (885/957) 92% during the two follow-up OSE visits along with sustenance and improvement in many important laboratory parameters. Conclusion' The co-sponsoring organisation (IRL) recognises the challenges and therefore, is committed to supporting state-level implementation of EQA through additional training, technical assistance to districts, and improving this technical guidance. By periodic IRL. EQA-OSE visits, sputum smear microscopy services can be sustained and improved at field level.
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Objective To investigate the testing capabilities of clinical transfusion laboratories in medical institutions in Beijing for the regulatory authorities to formulate administrative policies in this regard.Methods Experts assigned by Beijing Clinical Transfusion Quality Control Center made on-site inspections at the transfusion laboratories in medical institutions using quality control products.They recorded the complete testing process of the operators as well as the instruments,detection reagents in use and the testing results,with statistics and analysis made to the data so collected.Results The pass rate of these on-site inspections was lower than that of the external quality assessment.Some laboratories failed to complete the testing of the quality control products in time and the actual operations in some laboratories were inconsistent to the guidelines.55.9％ of level Ⅰ hospitals and 25.6％ of level Ⅱ hospitals were found with insufficient and inadequate instruments and process layout to meet the needs of clinical blood transfusion.Some of the technicians were found without sufficient trainings in their professional knowledge and basic skills,resulting in their poor competence against emergency cases and weakness in independent problem solving.In addition,the records of detection process and results were found to be substandard.Conclusions Transfusion laboratories in Beijing need to improve their testing capabilities in general.
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Objective: To assess the proficiency of Senior TB Laboratory Supervisors (STLSs) and district level Laboratory Technicians (LTs) in sputum smear microscopy. Method: Intermediate Reference Laboratory (IRL), Ahmedabad had manufactured and validated Proficiency Panel Testing slides from sputum samples, made On Site Evaluation (OSE) visits of District TB Centres (DTCs) in two rounds, and conducted Proficiency Panel Testing of STLSs & DTC-LTs from January 2005 to June 2009. Results: High level of concordance in Z-N smear grading was found between Microbiologist and district laboratory staff. DTC readers reported overall consistency level of more than 98% in Z-N grade agreement during both the IRL, EQA, OSE visits. The tendency to over-grade the panel slides was much higher (more than 22%) as compared to under-grade (less than 2%) them in “correct slides”. High False Positive (HFP) error was not observed in the present study. Conclusion: Laboratory supervisor’s proficiency can be quickly assessed by Proficiency Panel Testing, under multi-level quality assurance network system of sputum smear microscopy in public health programmes like the RNTCP. Proficiency Panel Testing is highly replicable and reproducible tool for quick and reliable assessment of proficiency of the staff and it can be made more effective by raising the proportion of lower grade positive slides in panel set of each reader. DTC readers’ overall agreement level of more than 98% in Z-N grade suggests high level of precision and excellent consistency during both the IRL, EQA, OSE rounds. It is concluded that even for a large network of sputum smear microscopy centres under public health programmes like the RNTCP in order to take corrective action, Proficiency Panel Testing can be effectively used for quick identification of suboptimal- technical performance of the supervisory staff.
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Two trials of external quality assessment were performed in 2008. The first and the second trials assessed by three test categories, i.e., tumor markers, thyroid hormones and immunoproteins (IgG, IgM, IgA, C3 and C4). Fifteen test items using immunoassay method were surveyed as scheduled. The number of participated laboratory of external quality assessment for Immunoassay Subcommittee were 437 institutions in the first trial survey and 476 institutions in the second survey.Fourteen control materials consisted of 12 home-made pooled sera and 2 commercial control sera (Liquimmune(R), Liquid Assayed Immunoassay Control, Microgenics Co, USA) were used. The results are summarized as follows. 1. Laboratories participating in external quality control program of immunoassay were 437 and 476 laboratories and the response rate were 94.6% and 98.7% in 2008. 2. Chemiluminiscence immunoassay autoanalyzers were most commonly used for immunoassay testing in the clinical laboratories for detecting tumor markers and hormones. 3. Some analyzers of a few test items showed variations of the test results of the same control material probably due to personal factors of the institution. 4. Workshops titled "Quality control of Immunoassay" and " Quality control of tumor markers" were held on September 5, 2008 and December 3, 2008 in cooperation with Annual Autumn Academic Conferences of Clinical laboratory and Quality Control and Immunoserology Subcommittee. The quality of the participating laboratories seems to be thought being continuously improved. And, this year, about 51 laboratories are newly participated to our Immunoassay Subcommittee.