ABSTRACT
Research fabrication and data fraud are one of the major concerns worldwide which are rising and evident from increasing number of retractions in peer reviewed Journals. If not checked, this can impact the reputation of a research organisation as well as the costs of translation of research data. In basic research extremely publicized cases of falsification of data have been reported and it is possible, that there are many unreported or undetected cases. In order to improve the quality standards, the validation processes were implemented for data quality at Neuroscience research lab in India for verifying PhD thesis results. Good Laboratory practices could be implicated in every research institute so that data impostures were prevented. We aimed to establish superior data quality by randomly verifying raw data in multiple projects funded by national agencies before publication of results at Neuroscience Research Lab.
ABSTRACT
Los Programas de Evaluación Externa de la Calidad (PEEC) de los laboratorios clínicos (LC) son indispensables para la comparación del desempeño en una o varias determinaciones de analitos entre diferentes laboratorios. Se evaluó el desempeño de los LC del estado Carabobo en la determinación de las concentraciones séricas de glucosa y creatinina. El estudio fue no experimental, descriptivo, de campo y de corte transversal. Se evaluaron 22 laboratorios entre públicos y privados del estado Carabobo. Se distribuyeron a cada LC 5 sueros controles (SC) nivel I (NI) y 5 nivel II (NII) para glucosa y creatinina. Se evaluó la imprecisión intra- e interlaboratorios, el sesgo y el error total de los resultados. No hubo LC con competencia para la determinación de glucosa y creatinina en ambos niveles ensayados. Solo 3 (13,3%) LC fueron competentes en la determinación de creatinina en el NI y NII. Se concluye que los resultados obtenidos en los SC de glucosa y creatinina no pueden ser transferibles entre los diferentes LC, por lo que es importante poner en marcha programas de control de calidad intralaboratorios o mejorar los existentes para eliminar los errores sistemáticos y disminuir los aleatorios, así como también se hace necesaria la participación en PEEC para determinar la universalización de los resultados emitidos por los LC.
External Quality Assessment Schemes (EQAS) of clinical laboratories (CL) are indispensable to compare performance in one or more analyte determinations among different laboratories. Performance of CL in Carabobo state for the determination of serum glucose and creatinine was evaluated. The study was not experimental, descriptive and cross-sectional field. A total of 22 public and private laboratories in Carabobo state were evaluated. Each CL was distributed 5 control sera (CS) level I (LI) and 5 level II (LII) for glucose and creatinine. Intra- and inter-laboratory precision, bias and total error of the results were evaluated. There was no CL competition for determining glucose and creatinine both levels tested. Only 3 (13.3%) CL were proficient in the determination of creatinine in the LI and LII. It can be concluded that the results obtained in CS glucose and creatinine may not be transferable between different CL, so it is important to implement quality control programs within laboratories or improve the existing ones to eliminate systematic errors and reduce randomization; besides, participation in EQAS is also necessary to determine the universalization of the CL results.
Os Programas de Avaliação Externa da Qualidade (PAEQ) dos laboratórios clínicos (LC) são essenciais para comparar o desempenho numa ou varias determinações de analitos entre diferentes laboratórios. Avaliou--se o desempenho dos LC do estado Carabobo na determinação das concentrações séricas de glicose e creatinina. O estudo foi não experimental, descritivo, de campo e seção transversal. Avaliaram-se 22 laboratórios entre públicos e privados do estado Carabobo. Foram distribuídos a cada laboratórios 5 soros controle (SC) nível I (NI) y 5 soros controle nível II (NII) para a glicose e creatinina. Foi avaliada a imprecisão intra e inter-laboratórios, o desvio percentual relativo e o erro total dos resultados. Não houve LC com competência para a determinação de glicose e creatinina em ambos os níveis testados. Apenas 3 (13,3%) LC foram competentes na determinação de creatinina no NI e NII. Conclui-se que os resultados obtidos nos SC de glicose e creatinina não podem ser transferíveis entre os diferentes LC, por isso é importante implementar programas de controle de qualidade intralaboratórios ou melhorar os já existentes para eliminar erros sistemáticos e reduzir os aleatórios; bem como se torna necessária a participação em PAEQ, para determinar a universalização dos resultados emitidos pelos LC.
Subject(s)
Clinical Laboratory Services/standards , Creatinine/analysis , Glucose/analysis , Quality Control , Clinical Laboratory Services , Clinical Laboratory Techniques/standards , Glucose/standards , Total Quality ManagementABSTRACT
Objective To investigate the intra-laboratory turnaround time(ILTAT) of the emergency biochemistry tests and to analyze the factors influencing ILTAT in order to adopt the corresponding improvement measures for perfecting the service quality and ensuring the patient medical safety.Methods ILTAT of the emergency biochemical specimens in our hospital from June to November 2015 was performed the retrospective statistics for comparing the determination timely rate between ILTAT≤60 min and ILTAT2 ≤120 min.ILTAT at different time periods in laboratory was emphatically analyzed.Results The determination timely rate of ILTAT ≤120min(ILTAT 1) was 98.8%(8638/8743),and which of ILTAT ≤60min(ILTAT 2) was 83.7%(7317/8743).The determination timely rate of ILTAT1 had no statistical difference among different time periods (χ2=3.36,P>0.05).The determination timely rate of ILTAT2 had statistical difference among different time periods(χ2=134.5,P<0.01).The determination timely rate of T 2(10:01-12:00) was highest (88.1%),which of T1 (8:01-10:00) was lowest(76.8%),which of T3(12:01-14:00) and T7 (6:01-8:00) was lower (79.4% and 80.2% respectively).Conclusion At present,ILTAT in our laboratory meets the requirements of the current regulations.Analyzing the ILTAT influencing factors in the emergency biochemistry,optimizing the workflow,improving the equipments and staffing allocation and improving the degree of information processing can further shorten the emergency biochemical ILTAT,and better meet the clinical and patient′s needs.
ABSTRACT
Objective To master the actual work efficiency situation of emergency inspection,analyze the existing problems,and provide objective basis for continuous improvement through the statistic analysis of intra-laboratory turn-around time (TAT) median,coincidence rate of inspection report within the specified time limit,report timeout reasons and other indexes of different items of emergency inspection group in 2015.Methods All kinds of original data from the different items of emergency inspection groupswere derived from LIS system,according to the different types of projects in different segments.Microsoft Excel2003 software was used to count the actual TAT time of various items,and function was used to calculate TAT median;The non-conformance rate (inspection report timeout rate) and coincidence rate within the prescribed time limit by inspection report were calculated,and gather the statistical analysis on the timeout reasons of daily recorded report.Results With the exception of electrochemical luminescence class,the TAT of other items decreased in different degrees of emergency inspection group in 2015 when compared with 2014.The average coincidence rate of inspection report of various items within the time limit was 94.8%,non-conformance rate of inspection report of prescribed time limit was 5.2%.The top four inspection timeout reasons of various items were more number of submitted samples(59.6%),redo the reinspection (12.4%),smear reinspection (12.0%) and equipment failure (10.0%) in turn.Conclusion The time limit of the emergency report meets the specified requirements and statistical analysis of the causes of overtime can find out the problems and take appropriate measures to provide an objective basis for continuous improvement.
ABSTRACT
For the first time a study was conducted to find out if there is actually a need to employ technical controls as an integral part in the management of diagnostic laboratories. The study involved biochemical, serological, parasitological and bacteriological units. While reproducibility was looked into in biochemical units, accuracy was studied in the other units. While it is presumed that internal controls exist in the units, the study brought out that they are not sensitive enough to detect changes which need appropriate remedial measures. It brought out variability of performance among workers and among laboratories. It showed also that an interlaboratory control can serve as an intralaboratory control. The acceptance of the need for controls will depend much on the inherent personal attitudes of the worker, the supervisor and the head of the laboratory. The proper attitude is necessary for its acceptance and implementation. Management of our diagnostic laboratories cannot be any different from management of a private firm where in the latter the manager controls the work for which he is accountable. (Summary)