Abstract:Double-blind sputum smear microscopy readings using a panel containing 75 slides (36 negative, 4 inconclusive, and 35 positive) proved to be appropriate for characterizing proficiency in sputum smear microscopy for the diagnosis of tuberculosis when such proficiency is intended to reproduce laboratory routine.
“…Vieira et al proposed double-blind sputum smear microscopy readings using a panel of 75 slides (36 negative, 4 inconclusive, 35 positive) to assess proficiency of readers and supervisors in TB smear microscopy ( 59 ). Dave et al assessed technical performance of laboratory supervisors using testing panels comprising 5 heat-fixed unstained sputum slides (including TB positives of any grade and negatives) for staining and examination; only 5% of 295 readers reported any type of error ( 60 ).…”
Section: Resultsmentioning
confidence: 99%
“…Few reports indicated the competency of staff conducting the rechecking process but relied on concordance of slide reading to determine accuracy; this can be addressed by including reference centre rechecking that assesses both peripheral laboratory technicians and their immediate supervisors; and conducting regular competency assessments of slide readers. Various standards have been proposed to assess competency in TB slide reading but only malaria microscopy has an established globally recognised competency assessment programme ( 52 , 59 , 60 ). Regular competency assessment of supervisors and reference-level staff urgently needs to be incorporated into national EQA programmes.…”
IntroductionHealth laboratory services are a critical component of national health systems but face major operational challenges in resource-limited (RL) settings. New funding for health systems strengthening in RL countries has increased the demand for diagnostics and provided opportunities to address these constraints. An approach to sustainably strengthen national laboratory systems in sub-Saharan African countries is the Strengthening Laboratory Management Toward Accreditation (SLMTA) programme. External Quality Assessment (EQA) is a requirement for laboratory accreditation. EQA comprises proficiency testing (PT), rechecking of samples and on-site evaluation.Materials and methodsA systematic literature search was conducted to identify studies addressing laboratory EQA and quality monitoring in RL countries. Unpublished reports were also sought from national laboratory authorities and personnel.ResultsPT schemes in RL countries are provided by commercial companies, institutions in developed countries and national programmes. Most government-supported PT schemes address single diseases using a vertical approach. Regional approaches to delivering PT have also been implemented across RL countries. Rechecking schemes address mainly tuberculosis (TB), malaria and human immunodeficiency virus (HIV); integrated rechecking programmes have been piloted. Constraints include sample transportation, communication of results, unknown proficiency of referee staff and limited resources for corrective action. Global competency assessment standards for malaria microscopists have been established.ConclusionsEQA is vital for monitoring laboratory performance and maintaining quality of laboratory services, and is a valuable tool for identifying and assessing technology in use, identifying gaps in laboratory performance and targeting training needs. Accreditation of PT providers and competency of EQA personnel must be ensured.
“…Vieira et al proposed double-blind sputum smear microscopy readings using a panel of 75 slides (36 negative, 4 inconclusive, 35 positive) to assess proficiency of readers and supervisors in TB smear microscopy ( 59 ). Dave et al assessed technical performance of laboratory supervisors using testing panels comprising 5 heat-fixed unstained sputum slides (including TB positives of any grade and negatives) for staining and examination; only 5% of 295 readers reported any type of error ( 60 ).…”
Section: Resultsmentioning
confidence: 99%
“…Few reports indicated the competency of staff conducting the rechecking process but relied on concordance of slide reading to determine accuracy; this can be addressed by including reference centre rechecking that assesses both peripheral laboratory technicians and their immediate supervisors; and conducting regular competency assessments of slide readers. Various standards have been proposed to assess competency in TB slide reading but only malaria microscopy has an established globally recognised competency assessment programme ( 52 , 59 , 60 ). Regular competency assessment of supervisors and reference-level staff urgently needs to be incorporated into national EQA programmes.…”
IntroductionHealth laboratory services are a critical component of national health systems but face major operational challenges in resource-limited (RL) settings. New funding for health systems strengthening in RL countries has increased the demand for diagnostics and provided opportunities to address these constraints. An approach to sustainably strengthen national laboratory systems in sub-Saharan African countries is the Strengthening Laboratory Management Toward Accreditation (SLMTA) programme. External Quality Assessment (EQA) is a requirement for laboratory accreditation. EQA comprises proficiency testing (PT), rechecking of samples and on-site evaluation.Materials and methodsA systematic literature search was conducted to identify studies addressing laboratory EQA and quality monitoring in RL countries. Unpublished reports were also sought from national laboratory authorities and personnel.ResultsPT schemes in RL countries are provided by commercial companies, institutions in developed countries and national programmes. Most government-supported PT schemes address single diseases using a vertical approach. Regional approaches to delivering PT have also been implemented across RL countries. Rechecking schemes address mainly tuberculosis (TB), malaria and human immunodeficiency virus (HIV); integrated rechecking programmes have been piloted. Constraints include sample transportation, communication of results, unknown proficiency of referee staff and limited resources for corrective action. Global competency assessment standards for malaria microscopists have been established.ConclusionsEQA is vital for monitoring laboratory performance and maintaining quality of laboratory services, and is a valuable tool for identifying and assessing technology in use, identifying gaps in laboratory performance and targeting training needs. Accreditation of PT providers and competency of EQA personnel must be ensured.
“…The variation in false positive result may be due to the difference in study settings, work environment and training level of the laboratory professionals. A false-positive result can cause severe consequences besides incurring financial costs, and a false-negative result causes harm to the patient due to the delay in diagnosis, incurs costs on society, and brings about loss of faith in the services offered by the laboratory [ 3 , 4 , 9 , 13 ]. Therefore, laboratories should undergo extensive review of their procedures and participate in a slide rechecking program in order to produce quality results.…”
BackgroundExternal quality assessment (EQA) of sputum smear microscopy is essential and indispensable component of any tuberculosis program. This study assessed the EQA of acid fast bacilli (AFB) smear microscopy through onsite evaluation, blinded rechecking and panel test. A one year study was conducted on eight health institution laboratories from December 2011 to December 2012. Onsite evaluation, blinded rechecking and panel tests were used to collect data. Data were analyzed using SPSS version 16. Sensitivity, specificity, predictive values, and proportions of false readings were calculated. The level of agreement was measured using Kappa (κ) value.ResultsProblems observed during onsite evaluation include shortages of materials, disinfectant, and poor storage and working condition. A total of 578 slides were collected for blinded rechecking, of which 102 (17.6 %) were reported as positive by peripheral laboratories. The panel test revealed an overall error of 17 (25.25 %) of which 14 (17.5 %) were minor errors [low false negative 6 (7.5 %) and low false positive 8 (10 %)], and 3 (3.75 %) were major errors (high false positive). The sensitivity, specificity, positive predictive values (PPV) and negative predictive values (NPV) of the peripheral laboratories were 83.5, 97.8, 91.7, and 95.7, respectively. The false readings at the peripheral laboratories were 32 (5.5 %). Agreement on reading the slides was observed on 546 (94.5 %) slides (K = 0.84, SE = 0.054).ConclusionsLack of reagents, supplies, favorable working environment and AFB related technical problems were identified in the peripheral laboratories. High false negative error was found to be the predominant major error. A continuous and strong EQA scheme should be implemented to avoid reporting errors and produce quality sputum results.
“…Além disso, chamou a atenção a seguinte unidade principal, também de ;BRUNO, 2009;MORAES;FILHO;ZAMIAN, 2009;FOGUEL et al, 2009;DI SOUZA;CASTRO, 2009;FRAGA;ZANONI, 2009], 9 fazem parte de textos de Pneumologia RIBEIRO, 2008;VIEIRA et al, 2008;FORTUNATO et al, 2008;SANTOS et al, 2008;HOLANDA et al, 2009;SOUSA et al, 2009;BRANDÃO et al, 2009;MUKAI;ALVES;NASCIMENTO, 2009;FELIX et al, 2009] e 4 integram textos de Educação Especial [PINOTTI;BOSCOLO, 2008;BRACCIALLI et al, 2008;GUARINELLO et al, 2009;MELO;FERREIRA, 2009].…”
Barzotto, pela orientação rigorosa, pelas leituras sensíveis e desconfiadas dos inúmeros rascunhos deste texto, pela insistência na formação de laços sociais para a pesquisa científica e por proporcionar a autonomia imprescindível para o crescimento de um pesquisador. Aos demais membros da banca do exame de qualificação, professores Dr. Luiz Antônio da Silva e Dra. Maria Elizabeth Leuba Salum, pelo diálogo franco sobre uma versão preliminar desta dissertação, troca fundamental para o seu amadurecimento. Às colegas de pós-graduação Kátia Zanvettor e Margarete Fátima Pauletto Sales e Silva, pelos apontamentos valiosos feitos a respeito de uma versão rudimentar deste texto. À Fundação de Amparo à Pesquisa do Estado de São Paulo, pelo apoio financeiro concedido (processo nº 2009/12793-0). A minha família, pelo incentivo constante à empresa intelectual e, em especial, a minha irmã, Solange, por ouvir e debater aspectos relacionados à pesquisa de mestrado, e a minha esposa, Tomomi, por observar e comentar os elementos gráficos deste texto e, ainda, por revisar a versão em Língua Japonesa do resumo.
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