Clinical application of a fully automated blood collection robot and its assessment of blood collection quality of anticoagulant specimens.

Background and objectives: To investigate the application of intelligent puncture blood collection robots in anticoagulated blood specimens, the satisfaction of subjects with the two blood collection methods, and the feasibility of intelligent blood collection devices to replace manual blood collection methods in clinical work. Materials and methods: A total of 154 volunteers from Zhongshan Hospital Fudan University were recruited to compare the test results of anticoagulant blood samples between blood collection robot and manual blood collection, a questionnaire was used to inquire about the volunteers' feelings about the two blood collection methods; the blood collection data of 6,255 patients willing to use the robot for blood collection were collected to analyze the success rate of blood collection. Results: The blood collection robot is superior to manual specimen collection in terms of volume and pain of specimen collection, and the puncture success rate is 94.3%. The anticoagulated blood specimens collected by the robot had 11 indexes statistically different from the results of manual blood collection, but the differences did not affect the clinical diagnosis and prognosis. Conclusion: The intelligent robotic blood collection is less painful and has better acceptance by patients, which can be used for clinical anticoagulated blood specimen collection.

[Impact of the analitycal quality for the infectious serology]. / Impacto de la calidad analítica para la serología infecciosa.

The application of quality and its scope have diversified. From this perspective, quality assurance applied to analytical tests (performed in clinical laboratories or blood banks) for the detection of infectious markers is one of the concepts that has gained strength in the last 10 years. The official Mexican standards require ensuring the quality of the published results and for their compliance it is recommended the use of international guides and guidelines that describe good practices that can be applied when carrying out this activity, without losing sight of the fact that everything related to quality assurance must be supported by the implementation of a quality management system. Thus, by using materials selected correctly and in accordance with official regulatory requirements, a good statistical analysis and the appropriate tools, the quality assurance of the analytical phase of the laboratory process in the screening of infectious markers can bring great benefits to the emission of clinically useful results by monitoring indicators and applying the necessary corrective actions, in order to reduce the risk of unfavorable results for patients and donors.

La aplicación de la calidad y su alcance se han diversificado. Bajo esta perspectiva, el aseguramiento de la calidad aplicado a las pruebas analíticas (que se hacen en laboratorios clínicos o bancos de sangre) para detectar marcadores infecciosos es uno de los conceptos que ha tomado fuerza en los últimos 10 años. Las normas oficiales mexicanas exigen asegurar la calidad de los resultados emitidos y para su cumplimiento se recomienda el uso de guías y lineamientos internacionales que describan las buenas prácticas que se pueden aplicar al llevar a cabo esta actividad, sin perder de vista que todo lo relacionado con el aseguramiento de la calidad debe estar sustentado mediante la implementación de un sistema de gestión de la calidad. Es así que mediante el uso de materiales seleccionados de manera correcta y acorde a los requerimientos normativos oficiales, un buen análisis estadístico y las herramientas adecuadas, el aseguramiento de la calidad de la fase analítica del proceso del laboratorio en el tamizaje de marcadores infecciosos puede aportar grandes beneficios a la emisión de resultados clínicamente útiles, mediante el seguimiento de indicadores y la aplicación de las acciones correctivas necesarias, con la finalidad de reducir el riesgo de resultados que desfavorezcan a pacientes y donadores.

Quantification of clinical mAb solutions using Raman spectroscopy: Macroscopic vs microscopic analysis.

Raman Spectroscopy is well emerged in the field of Analytical Quality Control (AQC) as a rapid and cost-effective technique useful in many applications. The advantage of Raman spectroscopy is the non-invasiveness of measurements that enablesto analyse samples directly in its container. In this study, the potential of Raman spectroscopy was investigated for analysis of clinical preparations of mAbs. Three commercial formulations of monoclonal antibodies (mAbs) Avastin®, Ontruzant® and Tecentriq® corresponding to Bevacizumab (BVC), Trastuzumab (TRS) and Atezolizumab (ATZ) respectively, were analysed in quartz cuvette in macroscopic analysis and through the wall of perfusion bags in microscopic analysis. The spectra have been compared to those of excipients (trehalose and sucrose) and of γ-Globulin, in order to investigate the origin of Raman bands. As expected, Raman spectra were a combination of bands from monoclonal antibodies and correspoding excipients found in formulas. For quantitative analysis of the solutions, models have been constructed using Partial Least Square Regression (PLSR) with Leave K-Out Cross Validation (LKOCV). The quantification performance was comparable for both macroscopic and microscopic analysis, in terms of error and linearity. The results are thus promising for future AQC in situ, in perfusion bags.

Optimization and Validation of Limit Check Error-Detection Performance Using a Laboratory-Specific Data-Simulation Approach: A Prerequisite for an Evidence-Based Practice.

BACKGROUND: Autoverification procedures based on limit checks (LCs) provide important support to preanalytical, analytical, and postanalytical quality assurance in medical laboratories. A recently described method, based on laboratory-specific error-detection performances, was used to determine LCs for all chemistry analytes performed on random-access chemistry analyzers prior to application. METHODS: Using data sets of historical test results, error-detection simulations of limit checks were performed using the online MA Generator system (www.huvaros.com). Errors were introduced at various positions in the data set, and the number of tests required for an LC alarm to occur was plotted in bias detection curves. Random error detection was defined as an LC alarm occurring in 1 test result, whereas systematic error detection was defined as an LC alarm occurring within an analytical run, both with ≥97.5% probability. To enable the lower limit check (LLC) and the upper limit check (ULC) to be optimized, the simulation results and the LC alarm rates for specific LLCs and ULCs were presented in LC performance tables. RESULTS: Optimal LLCs and ULCs were obtained for 31 analytes based on their random and systematic error-detection performances and the alarm rate. Reliable detection of random errors greater than 60% was only possible for analytes known to have a rather small variation of results. Furthermore, differences for negative and positive errors were observed. CONCLUSIONS: The used method brings objectivity to the error-detection performance of LCs, thereby enabling laboratory-specific LCs to be optimized and validated prior to application.

Evaluación externa de la calidad en laboratorios clínicos del nivel primario de la provincia Camagüey / External quality assessment in clinical laboratories of the primary health care in Camagüey

RESUMEN Introducción: La evaluación externa de la calidad es un procedimiento que compara los resultados de varios laboratorios que analizan la misma muestra, con el propósito de evaluar el desempeño analítico y asegurar la calidad. La provincia Camagüey fue incluida en forma permanente en el programa de evaluación externa de la calidad desde que se inició hasta que por diferentes dificultades nacionales y provinciales dicho programa no pudo continuar. Desde entonces, el comité de calidad de la provincia decidió organizar alternativas de evaluación con este propósito. En el 2016 se aplicó una nueva propuesta de evaluación en los laboratorios clínicos del nivel primario de atención. Objetivo: Evaluar la calidad de los resultados obtenidos en el procesamiento de los componentes de química clínica, en los laboratorios del nivel primario de la provincia Camagüey. Métodos: Se realizó un estudio descriptivo transversal desde septiembre de 2017 hasta julio de 2018, el universo estuvo constituido por todos los laboratorios clínicos de la provincia Camagüey y se trabajó con una muestra no probabilística de 14 laboratorios. Resultados: El desempeño analítico de colesteroles, glucemia y creatinina fue aceptable y los triglicéridos no aceptables, un policlínico del municipio Camagüey mostró el menor por ciento de error de medida de precisión y de exactitud. Conclusiones: Los resultados de los colesteroles mostraron los mejores desempeños analíticos y los resultados obtenidos fueron más exactos que precisos en los componentes evaluados. Fue elevado el por ciento de participación de los laboratorios 04 y 09 durante todo el tiempo que duró el estudio.

ABSTRACT Introduction: External quality assessment is a procedure that compares the results of several laboratories that analyze the same sample, with the purpose of evaluating analytical performance and assuring quality. Camagüey participated constantly in the external quality assessment program from the beginning until, due to different national and provincial difficulties, said program could not continue. Since then, the province(s quality committee decided to organize assessment alternatives for this purpose. In 2016, a new assessment proposal was applied in clinical laboratories al the primary level of care. Objective: To evaluate the quality of the results obtained in the processing of clinical chemistry components in primary level laboratories in the province of Camagüey. Methods: A cross-sectional descriptive study was carried out from September 2017 to July 2018, the universe consisted of all clinical laboratories in the province of Camagüey and a non-probabilistic sample of 14 laboratories was used. Results: The analytical performance of cholesterol, blood-glucose level and creatinine was acceptable and triglycerides were unacceptable. A polyclinic in the municipality of Camagüey showed the lowest percentage of precision and accuracy measurement error. Conclusions: The cholesterols results showed the best performances and the results obtained were more exact than precise in the evaluated components. The participation percentage of laboratories 04 and 09 was high throughout the duration of the study.

Pharmacists' experience of a diabetes risk-assessment service and analytical quality control in community pharmacies - A focus-group study.

BACKGROUND: Healthcare services such as diabetes risk-assessment are increasingly common in community pharmacies. Knowledge of community pharmacists' experiences of such services could ease the implementation of a larger-scale service. OBJECTIVES: To explore Norwegian pharmacists' experience of a diabetes risk-assessment service, including analytical quality control, in a community-pharmacy setting. METHODS: Three focus-group interviews were conducted in Norway between August and September 2017. Systematic text condensation was used, an analytic approach well suited for thematic content analysis across interview data. Fourteen pharmacists took part, recruited from a project offering a diabetes risk-assessment service, including measurements of Glycated hemoglobin A1c (HbA1c), in Norwegian community pharmacies. RESULTS: The pharmacists emphasized the importance of using their knowledge and skills to promote good health. They considered offering this service as being compatible with their role as pharmacists. As communication is an essential part of their work, the pharmacists evaluated their communication skills as being good. Nevertheless, how to communicate the offering of this service was seen as a challenge, for instance recruiting participants and communicating in an understandable and professional way. Inclusion of the whole pharmacy staff as a team was experienced as an important success factor for implementation of a risk-assessment service. Analytical quality control was perceived as being a natural part of their job and a manageable task. CONCLUSIONS: Offering a diabetes risk-assessment service is in line with the way a selected group of Norwegian community pharmacists perceived their professional role. However, they were uncomfortable recruiting participants, and expressed the wish for more support from the pharmacy chain. Our results add performance of analytical quality control as part of the ongoing development involving expansion of pharmacists' professional role. Future implementation studies may also benefit from giving both the pharmacy staff and customers sufficient time to familiarize themselves with the new service before measuring effects.

In situ Analytical Quality Control of chemotherapeutic solutions in infusion bags by Raman spectroscopy.

Analytical Quality Control (AQC) in centralised preparation units of oncology centers is a common procedure relying on the identification and quantification of the prepared chemotherapeutic solutions for safe intravenous administration to patients. Although the use of Raman spectroscopy for AQC has gained much interest, in most applications it remains coupled to a flow injection analyser (FIA) requiring withdrawal of the solution for analysis. In addition to current needs for more rapid and cost-effective analysis, the risk of exposure of clinical staff to the toxic molecules during daily handling is a serious concern to address. Raman spectroscopic analysis, for instance by Confocal Raman Microscopy (CRM), could enable direct analysis (non-invasive) for AQC directly in infusion bags. In this study, 3 anticancer drugs, methotrexate (MTX), 5-fluorouracil (5-FU) and gemcitabine (GEM) have been selected to highlight the potential of CRM for withdrawal free analysis. Solutions corresponding to the clinical range of each drug were prepared in 5% glucose and data was collected from infusion bags placed under the Raman microscope. Firstly, 100% discrimination has been obtained by Partial Least Squares Discriminant Analysis (PLS-DA) confirming that the identification of drugs can be performed. Secondly, using Partial Least Squares Regression (PLSR), quantitative analysis was performed with mean % error of predicted concentrations of respectively 3.31%, 5.54% and 8.60% for MTX, 5-FU and GEM. These results are in accordance with the 15% acceptance criteria used for the current clinical standard technique, FIA, and the Limits of Detection for all drugs were determined to be substantially lower than the administered range, thus highlighting the potential of confocal Raman spectroscopy for direct analysis of chemotherapeutic solutions.

Avaliação de desempenho analítico do equipamento de hematologia de um laboratório de análises clínicas da Serra Gaúcha através da métrica Seis Sigma / Evaluation of the analytical performance of the hematology equipment of a Serra Gaúcha clinical analysis laboratory through Six Sigma metric

Objetivo: Avaliar o desempenho do equipamento Mindray® BC-5380 através da métrica sigma. Métodos: Os parâmetros incluídos neste estudo são leucócitos, eritrócitos, hemoglobina, hematócrito, volume corpuscular médio, hemoglobina corpuscular média, concentração de hemoglobina corpuscular média, amplitude de distribuição dos eritrócitos e plaquetas. Os cálculos foram realizados a partir de dados provenientes da rotina de controle de qualidade do laboratório, determinando-se a inexatidão, imprecisão, o erro total analítico e a métrica sigma dos parâmetros. Resultados: Valores aceitáveis de Sigma (>3) calculados com base nas especificações da qualidade CLIA foram encontrados para todos os parâmetros, exceto hematócrito. Calculando-se a métrica com base em especificações de variação biológica, hematócrito, volume corpuscular médio e hemoglobina corpuscular média apresentam desempenho inaceitável em pelo menos algum nível de controle, e a concentração de hemoglobina corpuscular média apresenta resultado inaceitável em todos os níveis. A contagem de leucócitos totais foi o único parâmetro com desempenho excelente em todos os níveis de controle, perante todas as especificações de qualidade aplicadas. Conclusão: A utilização da métrica sigma na avaliação do desempenho analítico permite identificar falhas não detectadas pelo controle de qualidade convencional, sendo um importante recurso para a melhoria contínua da qualidade.

Objective: To evaluate the performance of the Mindray® BC-5380 equipment using the sigma metric. Methods: The parameters included in this study are leukocytes, erythrocytes, hemoglobin, hematocrit, average corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, red cell distribution width and platelets. The calculations were performed based on data from the laboratory's quality control routine, determining inaccuracy, imprecision, total analytical error and the sigma metric of the parameters. Results: Acceptable values of Sigma (> 3) calculated based on CLIA specifications were found for all parameters, except hematocrit Calculating the metric based on specifications of biological variation, hematocrit, mean corpuscular volume and mean corpuscular hemoglobin present unacceptable performance in at least one level of control, and the mean corpuscular hemoglobin concentration shows unacceptable results at all levels. The total leukocyte count was the only parameter with excellent performance at all levels of control, with the quality specifications applied. Conclusion: The use of the sigma metric in the evaluation of analytical performance allows to identify flaws not detected by conventional quality control, being an important resource for continuous quality improvement.

Ten-Month Evaluation of the Routine Application of Patient Moving Average for Real-Time Quality Control in a Hospital Setting.

BACKGROUND: In recent years there has been renewed interest in patient-based real-time quality control (PBRTQC) techniques. This interest has been stimulated by the availability of new optimization and validation methods. Only a limited amount of research has focused on investigating the true operational value of PBRTQC. Therefore, we have evaluated the performance and value of recently implemented patient moving average quality control (MA QC) procedures. METHODS: The MA QC settings and protocols were as previously described (Clin Chem Lab Med 2019;57:1329-38) and included MA QCs for 10 chemistry and 6 hematological tests, all performed on duplicate analyzer systems. All MA QC alarms that occurred during the first 10 months of routine clinical application were investigated for assay-specific alarm rate and occurrence in time. Furthermore, the causes of these MA QC alarms were investigated, and alarm relevance was determined on the basis of total allowable bias (TBa) and error (TEa) derived from biological variations. RESULTS: During the 10-month period, 202 individual MA QC alarms occurred, resulting in an overall MA QC alarm rate of 0.030% and a frequency of 4.67 per week. Most alarms were triggered by sodium MA QC. Based on all available fully executed and documented MA QC alarm work-ups, MA QC detected errors that in 26.0% of the alarms exceeded the TBa and in 13.7% the TEa. In 9.2% of the alarms, MA QC alarming triggered instant (technical) corrections. CONCLUSIONS: Routine clinical application of MA QC is feasible with maintaining a manageable number of alarms and enabling detection of relevant analytical errors.

Determination of Total Silicon and SiO2 Particles Using an ICP-MS Based Analytical Platform for Toxicokinetic Studies of Synthetic Amorphous Silica.

Synthetic amorphous silica (SAS), manufactured in pyrogenic or precipitated form, is a nanomaterial with a widespread use as food additive (E 551). Oral exposure to SAS results from its use in food and dietary supplements, pharmaceuticals and toothpaste. Recent evidence suggests that oral exposure to SAS may pose health risks and highlights the need to address the toxic potential of SAS as affected by the physicochemical characteristics of the different forms of SAS. For this aim, investigating SAS toxicokinetics is of crucial importance and an analytical strategy for such an undertaking is presented. The minimization of silicon background in tissues, control of contamination (including silicon release from equipment), high-throughput sample treatment, elimination of spectral interferences affecting inductively coupled plasma mass spectrometry (ICP-MS) silicon detection, and development of analytical quality control tools are the cornerstones of this strategy. A validated method combining sample digestion with silicon determination by reaction cell ICP-MS is presented. Silica particles are converted to soluble silicon by microwave dissolution with mixtures of HNO3, H2O2 and hydrofluoric acid (HF), whereas interference-free ICP-MS detection of total silicon is achieved by ion-molecule chemistry with limits of detection (LoDs) in the range 0.2-0.5 µg Si g-1 for most tissues. Deposition of particulate SiO2 in tissues is assessed by single particle ICP-MS.

An approach to selecting auto-verification limits and validating their error detection performance independently for pre-analytical and analytical errors.

BACKGROUND: Auto-verification limits are widely used to trigger confirmatory actions to enable detection of pre-analytical, analytical and post-analytical errors. An approach is presented for validating auto-verification limit performance in a laboratory-specific manner, independently for pre-analytical and analytical error detection. METHODS: To evaluate this approach, MA Generator (www.huvaros.com) was used to run error-detection simulations using various upper-limit checks (ULC) and lower-limit checks (LLC). Pre-analytical error detection was defined as triggering of a limit check alarm within one erroneous result. Analytical error detection was defined as triggering a limit check alarm within the scheduled internal QC measurement interval, both with ≥97.5% probability. Furthermore, the limit check alarm rates were obtained. RESULTS: Pre-analytical error detection and rapid detection of larger analytical errors by limit checks outperformed moving average quality control at the cost of a significantly larger number of alarms. A pre-analytical error detection by LLC and ULC of ≥-55% and >60%, ≥-10% and ≥20%, and ≥-40% and ≥50% and an analytical error detection of ≥-4% and ≥15%, ≥-3% and ≥4% and ≥-30% and ≥25% were obtained for hemoglobin, sodium and calcium, respectively. CONCLUSIONS: The obtained ULC and LLC alarm rate and error detection performance, enabled substantiated selection of optimal auto-verification limits and validation thereof.

Design and implementation of quality control plans that integrate moving average and internal quality control: incorporating the best of both worlds.

Background New moving average quality control (MA QC) optimization methods have been developed and are available for laboratories. Having these methods will require a strategy to integrate MA QC and routine internal QC. Methods MA QC was considered only when the performance of the internal QC was limited. A flowchart was applied to determine, per test, whether MA QC should be considered. Next, MA QC was examined using the MA Generator (www.huvaros.com), and optimized MA QC procedures and corresponding MA validation charts were obtained. When a relevant systematic error was detectable within an average daily run, the MA QC was added to the QC plan. For further implementation of MA QC for continuous QC, MA QC management software was configured based on earlier proposed requirements. Also, protocols for the MA QC alarm work-up were designed to allow the detection of temporary assay failure based on previously described experiences. Results Based on the flowchart, 10 chemistry, two immunochemistry and six hematological tests were considered for MA QC. After obtaining optimal MA QC settings and the corresponding MA validation charts, the MA QC of albumin, bicarbonate, calcium, chloride, creatinine, glucose, magnesium, potassium, sodium, total protein, hematocrit, hemoglobin, MCH, MCHC, MCV and platelets were added to the QC plans. Conclusions The presented method allows the design and implementation of QC plans integrating MA QC for continuous QC when internal QC has limited performance.

Moving average quality control: principles, practical application and future perspectives.

Moving average quality control (MA QC) was described decades ago as an analytical quality control instrument. Although a potentially valuable tool, it is struggling to meet expectations due to its complexity and need for evidence-based guidance. For this review, relevant literature and the world wide web were examined in order to (i) explain the basic concepts and current understanding of MA QC, (ii) discuss moving average (MA) optimization methods, (iii) gain insight into practical aspects related to applying MA in daily practice and (iv) describe future prospects to enable more widespread acceptance and application of MA QC. Each of the MA QC optimization methods currently available has their own advantages and disadvantages. Recently developed simulation methods provide realistic error detecting properties for MA QC and are available for laboratories. Operational MA management issues have been identified that allow developers of MA software to upgrade their packages to support optimal MA QC application and guide laboratories on MA management issues, such as MA alarm workup. The new insights into MA QC characteristics and operational issues, together with supporting online tools, may promote more widespread acceptance and application of MA QC.

Study on the stability of HIV and syphilis reference materials under varied temperature conditions during their transportation / Estudo da estabilidade de materiais de referência para HIV e sífilis sob condições de temperatura variadas durante o transporte

ABSTRACT Introduction: The objective of this study was to evaluate the short-term stability of the serum samples used as internal quality control (IQC) of human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (Aids) and syphilis immunodiagnostic assays. These samples were produced at the Center of Immunology-Instituto Adolfo Lutz (IAL), and they were distributed to laboratories participating in the IAL Quality Control Program. Method: The sera analyzed by chemiluminescence assay were stored at varied temperature conditions: from 2ºC to 8ºC (refrigerator), from 15ºC to 25ºC (room temperature), at 37ºC (incubator) and at -20ºC (reference temperature) for 12 and 24 hours. Results: Comparative analysis of IQC results for anti-HIV and anti-T. pallidum (anti-treponemal) showed stability in the reference temperature and at the various simulated temperatures for transporting the samples at the established lengths of time. The data from the simple linear regression analysis of negative serum samples (incubator/24 hours) and in one batch of HIV IQC (room temperature/24 hours) were statistically significant at the level of 5% (p-value < 0.05). Conclusion: The sera presented necessary requirements as reference material to be transported to laboratories at refrigeration temperature (2ºC to 8ºC), at the maximum shipping time of 12 hours.

RESUMO Introdução: O objetivo deste estudo foi avaliar a estabilidade de curta duração de amostras de soro utilizadas como controle de qualidade interno (CQI) de testes imunodiagnósticos de vírus da imunodeficiência humana (HIV)/síndrome da imunodeficiência adquirida (Aids) e sífilis, produzidas no Centro de Imunologia do Instituto Adolfo Lutz (IAL) e distribuídas aos laboratórios participantes do Programa de Controle de Qualidade do IAL. Método: Os soros analisados por meio de ensaio de quimioluminescência foram armazenados em diferentes condições de temperaturas: de 2ºC a 8ºC (geladeira), de 15ºC a 25ºC (ambiente), 37ºC (estufa) e de -20ºC (referência) durante 12 e 24 horas. Resultados: A análise comparativa dos resultados do CQI HIV e T. pallidum (antitreponêmico) demonstrou que os materiais permaneceram estáveis, tanto na temperatura de referência quanto nas diferentes temperaturas simuladas para o transporte, no período de tempo estabelecido. No entanto, os resultados da análise de regressão linear simples das amostras de soro negativas (estufa/24 horas) e de um lote de CQI HIV (ambiente/24 horas) foram estatisticamente significativos ao nível de 5% (valor de p < 0,05). Conclusão: Os soros apresentaram requisitos necessários de material de referência para serem transportados aos laboratórios em temperatura de refrigeração (2ºC a 8ºC) no tempo máximo de 12 horas.

Sunway Medical Laboratory Quality Control Plans Based on Six Sigma, Risk Management and Uncertainty.

Sunway Medical Centre (SunMed) implemented Six Sigma, measurement uncertainty, and risk management after the CLSI EP23 Individualized Quality Control Plan approach. Despite the differences in all three approaches, each implementation was beneficial to the laboratory, and none was in conflict with another approach. A synthesis of these approaches, built on a solid foundation of quality control planning, can help build a strong quality management system for the entire laboratory.

Analysis of the frequency of biological sample recollections as quality indicators in a clinical laboratory of Distrito Federal, Brazil / Análise da frequência de recoletas de amostras biológicas como indicadores de qualidade em um laboratório de análises clínicas do Distrito Federal, Brasil

ABSTRACT Introduction: Clinical laboratory results influence more than 60% of medical decisions, impacting on disease prevention, diagnosis, and treatment. The use of quality indicators (QIs) is fundamental for quality assurance, once it allows monitoring the process and directs the taking of corrective actions. Objective: Classify the biological sample recollection requests for QIs identification in a clinical laboratory of Distrito Federal, Brazil. Material and methods: Data about the requests made in the biennium 2013-2014 were gathered and analyzed. Results and discussion: Among the 304,361 samples received, 1,914 (0.62%) had a request for recollection made in accordance with laboratory criteria. Most orders originated in the pre-analytical phase (57.7%). The most frequent reason for sample rejection was result confirmation (40.7%), followed by insufficient sample (21.9%), coagulated sample (18.1%) and hemolyzed sample (11, 9%). The hematology sector was responsible for most recollection requests (43.6%), followed by the biochemistry (29%) and the immunology (25.7%) ones. The laboratory emergency department accounted for only 0.1%. Orders were mostly placed by the outpatient clinic (40.7%), emergency (30.4%), and internal medicine (12.4%) departments. The percentage of orders is low, but does not exclude the need to reach lower rates. Underreporting was detected in the emergency sector, which indicates need for improvement in information registration. Conclusion: The numbers mentioned were selected as IQs for the pre-analytical phase, serving as guidelines for future actions taken by the team.

RESUMO Introdução: Os resultados dos testes laboratoriais influenciam mais de 60% das decisões médicas, impactando na prevenção, no diagnóstico e no tratamento de doenças. O uso de indicadores de qualidade (IQs) é fundamental para a garantia da qualidade, pois permite monitoramento do processo e direciona a implementação de ações corretivas. Objetivo: Classificar pedidos de recoleta de amostras biológicas para identificação de IQs em um laboratório de análises clínicas do Distrito Federal. Material e métodos: Foram coletados e analisados dados acerca de pedidos de recoleta feitos no biênio 2013-2014. Resultados e discussão: Das 304.361 amostras registradas, 1.914 (0,62%) tiveram solicitação de recoleta de acordo com os critérios do laboratório. A maioria dos pedidos teve origem na fase pré-analítica (57,7%). O motivo de rejeição mais frequente foi confirmação de resultado (40,7%), seguido por amostra insuficiente (21,9%), amostra coagulada (18,1%) e amostra hemolisada (11,9%). O setor de hematologiafoi o responsável pelo maior número de pedidos de recoletas (43,6%), seguido pelo de bioquímica (29%) e o de imunologia (25,7%). O setor de emergência do laboratório representou apenas 0,1%. Quanto à procedência, a maioria das recoletas foi solicitada pelo ambulatório (40,7%), pelo pronto-socorro (30,4%) e pela clínica médica (12,4%). A porcentagem de pedidos de recoleta é baixa, porém não exclui a necessidade de busca por menores índices. Sugere-se que tenha ocorrido subnotificação no setor de emergência do laboratório, o que aponta necessidade de melhoria no registro de informações. Conclusão: Os números destacados foram selecionados como IQs para a fase pré-analítica, servindo como norteadores para as futuras ações corretivas efetuadas pela equipe.

Evaluation of analytical errors in a clinical chemistry laboratory: a 3 year experience.

BACKGROUND: Proficient laboratory service is the cornerstone of modern healthcare systems and has an impact on over 70% of medical decisions on admission, discharge, and medications. In recent years, there is an increasing awareness of the importance of errors in laboratory practice and their possible negative impact on patient outcomes. AIM: We retrospectively analyzed data spanning a period of 3 years on analytical errors observed in our laboratory. The data covered errors over the whole testing cycle including pre-, intra-, and post-analytical phases and discussed strategies pertinent to our settings to minimize their occurrence. MATERIALS AND METHODS: We described the occurrence of pre-analytical, analytical and post-analytical errors observed at the Komfo Anokye Teaching Hospital clinical biochemistry laboratory during a 3-year period from January, 2010 to December, 2012. Data were analyzed with Graph Pad Prism 5(GraphPad Software Inc. CA USA). RESULTS: A total of 589,510 tests was performed on 188,503 outpatients and hospitalized patients. The overall error rate for the 3 years was 4.7% (27,520/58,950). Pre-analytical, analytical and post-analytical errors contributed 3.7% (2210/58,950), 0.1% (108/58,950), and 0.9% (512/58,950), respectively. The number of tests reduced significantly over the 3-year period, but this did not correspond with a reduction in the overall error rate (P = 0.90) along with the years. CONCLUSION: Analytical errors are embedded within our total process setup especially pre-analytical and post-analytical phases. Strategic measures including quality assessment programs for staff involved in pre-analytical processes should be intensified.

Routine application of Raman spectroscopy in the quality control of hospital compounded ganciclovir.

This study compares the performance of a reference method of HPLC to Raman spectroscopy (RS) for the analytical quality control (AQC) of therapeutic objects. We assessed a model consisting of a widely used antiviral drug, i.e., ganciclovir, which was compounded in a medical device and then transferred in a vacuum glass vial prior to analyses. As the aim of the alternative RS method is to replace the destructive, time-consuming HPLC method, requiring sample preparation, it needs to be demonstrated that RS performs at least as good as the HPLC method. Therefore, the two methods were validated by calculating the accuracy profile and provided excellent results for the analytical validation key criteria, i.e., trueness, precision and accuracy, ranging from 0.8 to 10mg/mL. The Spearman and Kendall correlation tests (p-value<1.10-15) and the statistical studies performed on the graphs confirm a strong correlation in the results between RS and the standard HPLC under the experimental conditions. These results confirmed the potential of this option for future applications, owing to its analytical and practical quality and its contributions to the safety of the medication circuit. This method also greatly contributes to the protection of caregivers and their working environment.

The contribution of Raman spectroscopy to the analytical quality control of cytotoxic drugs in a hospital environment: eliminating the exposure risks for staff members and their work environment.

The purpose of the study was to perform a comparative analysis of the technical performance, respective costs and environmental effect of two invasive analytical methods (HPLC and UV/visible-FTIR) as compared to a new non-invasive analytical technique (Raman spectroscopy). Three pharmacotherapeutic models were used to compare the analytical performances of the three analytical techniques. Statistical inter-method correlation analysis was performed using non-parametric correlation rank tests. The study's economic component combined calculations relative to the depreciation of the equipment and the estimated cost of an AQC unit of work. In any case, analytical validation parameters of the three techniques were satisfactory, and strong correlations between the two spectroscopic techniques vs. HPLC were found. In addition, Raman spectroscopy was found to be superior as compared to the other techniques for numerous key criteria including a complete safety for operators and their occupational environment, a non-invasive procedure, no need for consumables, and a low operating cost. Finally, Raman spectroscopy appears superior for technical, economic and environmental objectives, as compared with the other invasive analytical methods.

Comparison of Raman spectroscopy vs. high performance liquid chromatography for quality control of complex therapeutic objects: model of elastomeric portable pumps filled with a fluorouracil solution.

This study compares the performance of a reference method of HPLC to Raman spectroscopy (RS) for the analytical quality control (AQC) of complex therapeutic objects. We assessed a model consisting of a widely used anticancer drug, i.e., 5-fluorouracil, which was compounded in a complex medical device, i.e., an elastomeric portable infusion pump. In view of the main objective, the two methods provided excellent results for the analytical validation key criteria, i.e., trueness, precision and accuracy, ranging from 7.5 to 50mg/mL and in either isotonic sodium or 5% dextrose. The Spearman and Kendall correlation tests (p-value<1×10(-15)) and the statistical studies performed on the graphs confirm a strong correlation in the results between RS and the standard HPLC under the experimental conditions. The selection of a spectral interval between 700 and 1400cm(-1) for both the characterization and quantification by RS was the result of a gradual process optimization, combining matrix and packaging responses. In this new application, we demonstrate at least eight benefits of RS: (a) operator safety, (b) elimination of disposables, (c) elimination of analysis waste, which contributes to the protection of the environment, (d) a fast analytical response of less than 2min, (e) the ability to identify the solubilizing phase, (f) reduction of the risk of errors because no intrusion or dilution are needed, (g) negligible maintenance costs and (h) a reduction in the budget dedicated to technician training. Overall, we indicate the potential of non-intrusive AQC performed by RS, especially when the analysis is not possible using the usual techniques, and the technique's high potential as a contributor to the safety of medication.