Non-touch treatment to solve the persistent contamination of culture plates with Aspergillus niger in a clinical microbiology laboratory of Spain.

A pseudo-outbreak of Aspergillus caused by false positive cultures can have a high sanitary impact. We determined the effectiveness (fungal load elimination) of a non-touch disinfection system, vs conventional disinfection methods, to solve steady contamination of culture plates with Aspergillus niger at a clinical microbiology laboratory. Routine cleaning-disinfection (RCD), intensive cleaning-disinfection (ICD), and terminal airborne disinfection (TAD) were employed in stages. Air sampling was carried out before and after each procedure. The effectiveness of TAD on contact surfaces was tested by surface sampling. After RCD, ICD, and TAD, there was a mean decrease of 5.4 (95% CI = 1.8-9.0), 19.2 (95% CI = 12.4-26.0), and 4.4 (95% CI = 2.5-6.3) CFU per tested area, and 46.2%, 21.7%, and 95.5% of contaminated areas became sterile, respectively. There was a mean decrease of 30.6 CFU per tested surface (p < 0.0007) and 50% of tested surfaces became sterile. Global effectiveness of RCD, ICD, and TAD was 68.8% (95% CI = 68.5-69.1), 82.2% (95% CI = 82.1-82.3), and 99.0% (95% CI = 98.8-99.2), respectively. The effectiveness was higher with TAD (4.1 CFU/cm2 less than with ICD; p = 0.0290). No further contamination has occurred since then. When construction and renovation activities are discarded and RCD and ICD practices are insufficient, non-touch disinfection remove residual dust contamination and avoid recurrence.

Assessment of the accuracy of estimated free phenytoin concentrations in a mixed patient population.

OBJECTIVES: Phenytoin is an anti-epileptic drug that has a narrow therapeutic index, and therefore requires therapeutic drug monitoring. Only the free fraction is pharmacologically active, and in some cases, accurate determination of the free phenytoin concentration may be essential to prevent phenytoin toxicity. Although it is possible to measure free phenytoin concentration, often only the total concentration is measured, with equations used to estimate the free fraction. Several equations are quoted in the literature with no overall consensus with regard to accuracy. This study aimed to assess the correlation between total and free phenytoin in a mixed patient population, and to compare the accuracy of several different equations used to estimate the free phenytoin concentration. METHODS: Fifty-one serum samples were analysed for total phenytoin, free phenytoin and albumin. The measured free phenytoin concentrations were compared against those estimated using five selected equations, identified through a literature search. RESULTS: This study showed poor correlation between the total and measured free phenytoin concentrations, and between the estimated and measured free concentrations. The overall correlation was concentration-dependent, but a correction factor could not be applied to improve the accuracy consistently. The equations assessed showed wide variability between the estimated and measured free phenytoin concentrations, with several showing a clinically significant negative bias when compared with the measured free fraction. DISCUSSION: This study highlights the disparity of the free phenytoin concentrations generated by the equations. Underestimation of free phenytoin concentrations using these equations may result in phenytoin toxicity, bringing into question the safety of using calculated values for patient management in place of physical measurement of free phenytoin concentration by ultra-performance liquid chromatography tandem mass spectrometry.

Automation of parenteral nutrition: impact on process and cost analysis.

OBJECTIVES: On the basis of its safety and accuracy, automation is recommended for parenteral nutrition (PN). The aim of this study was to highlight the changes in practices related to the automation of PN and to perform a cost study comparing manual vs automated production costs. METHODS: We conducted a micro-costing study using 1 year of manual production data for adult, neonatal and paediatric PN bagsat a hospital. We used the data to estimate the costs of automating the production process for adult, neonatal and paediatric bags. RESULTS: Major modification to the PN production process resulted in: rationalisation of raw materials, computerisation and optimisation of human needs. Switching from a manual to an automated process reduced the cost of neonatal/paediatric custom bags (€130.73 vs €124.58) and semi-custom bags (€172.08 vs €166.86); but increased the cost of adult bags (€93.06 vs €127.92). CONCLUSIONS: The changes resulting from the automation and revision of the production process globally increased annual expenditures by approximately 9.7%. However, automation minimised the risk of misproduction, bag contamination, and led to a more secure production process that reduced risks incurred by the teams. In view of the gain in patient and staff safety (linked to the use of an automated compounding device) the moderate economic impact (<10%) should not deter the automation of PN production circuits.

Performance evaluation of the HPLC diode array and evaporative light scattering detection for the implementation of dose-banded gemcitabine infusion bags.

BACKGROUND: Dose banding (DB) was used to optimise the individualisation of patient treatments with gemcitabine (Gem) in order to improve workload planning at the pharmacy of the University Hospital Centre of Besançon (UHCB). A new simple and fast high-performance liquid chromatographic (HPLC) method was also developed for the quantification of Gem without dilution of the infusion bags. METHODS: Individual doses of Gem preparations were retrospectively analysed over a 1-year period to determine the frequency of prepared doses. Using a maximum gap of 7.5% around the doses chosen, the selected Gem standard doses were 1400 mg, 1600 mg, 1800 mg and 2000 mg. Following the DB scheme, the frequency of prescription of standard and individualised Gem doses was analysed over a period of 10 months. The four selected Gem standard doses were aseptically prepared in polyolefin infusion bags. Each series of 20 bags was stocked under refrigerated storage conditions (4°C) for up to 84 days. The quantification of Gem without dilution of the infusion bags was obtained by the development of a HPLC method coupled to a diode array detector (DAD) or an evaporative light scattering detector (ELSD). RESULTS: During the 10-month period following implementation of the DB, 75.6% of the 1266 prescribed doses were covered by the four standardised preparations. The number of different Gem doses was reduced from 183 to 55. Concerning the Gem quantification, both heteroscedasticity and non-linearity were observed with DAD. Using an ELSD, the trueness values were between 98.59% and 101.52% with excellent repeatability values between 0.66% and 1.42%. CONCLUSION: A new HPLC method has been developed for the quantification of Gem without dilution of the infusion bags prepared in advance as a result of a target DB scheme successfully implemented in our pharmacy department.

Novel approach to adherence assessment based on parent drug and metabolite pharmacokinetics: pilot study with spironolactone.

AIM: The aim of this study was to evaluate adherence to spironolactone in a group of unselected patients with arterial hypertension by analysis of measured serum spironolactone and canrenone concentrations according to a proposed two-step decision scheme based on pharmacokinetic considerations. MATERIALS AND METHODS: Simulation of serum concentration-time profiles of spironolactone and canrenone based on population pharmacokinetic parameters described in literature and a body weight-normalized spironolactone dose / canrenone level nomogram derived from a group of adherent patients with conservatively treated primary hyperaldosteronism, were used to create a two-step decision scheme. 71 outpatients treated with spironolactone for resistant hypertension with spironolactone and canrenone serum concentrations measured between 2018 and 2021 were analyzed according to the proposed scheme. We compared our proposed methodology to the standard approach for adherence testing. RESULTS: With the most sensitive traditional approach to adherence assessment through detectable serum concentrations of spironolactone and/or canrenone, 9 (12.7%) non-adherent patients were identified. With our two-step assessment of adherence, we were able to identify 18 (25.4%) non-adherent patients. CONCLUSION: Consideration of the pharmacokinetic properties of parental drug and its metabolite led to improved sensitivity in non-adherence detection in patients with arterial hypertension. This approach enables better interpretation of measured spironolactone and canrenone serum concentrations and should be used in clinical practice.

Major changes will take place on ISO15189 "Medical laboratories: requirements for quality and competence" / 中华检验医学杂志

Since the first edition of ISO15189"Medical laboratories: requirements for quality and competence" was published in 2003, it has been rapidly and widely used in the world under the promotion of the International Laboratory Accreditation Cooperation Organization (ILAC), and has become the basic standard for the quality management, capacity-building and capacity attestation of medical laboratories. The Mutual Recognition Arrangement (MRA) of ILAC for ISO15189 is the most authoritative international permit for examination results, which is accepted by international organizations. Since the establishment of ISO15189 medical laboratory accreditation system in 2004 in China, more than 530 medical laboratories have been accredited, which plays an important role in improving the quality and competence of medical laboratories in China, and improves the influence of Chinese medical laboratories in the world. ISO 15189:2012 is currently being revised by the International Organization for Standardization/Technical Committee on Clinical Laboratory Testing and in vitro diagnostic test systems (ISO/TC212). This revision will bring significant changes and the medical laboratory shall pay attention to these changes. In order to help medical laboratories understand the new ideas in advance, this paper summarizes and analyses the draft of the new international standards, and provides references for users.

Proposal for detection of 2019-nCoV nucleic acid in clinical laboratories / 中华检验医学杂志

In December, the outbreak of a novel coronavirus (2019-nCoV) in Wuhan, China, has attracted extensive global attention. On January 20, 2020,the Chinese health authorities upgraded the coronavirus to a Class B infectious disease in the Law of the People's Republic of China on the Prevention and Treatment of Infectious Diseases, and considered it as Class A infectious diseases in disease control and prevention. On January 22, 2020, the 2019-nCoV nucleic acid detection test was listed as the diagnostic criteria in the "guidelines for diagnosis and treatment of pneumonia due to 2019-nCoV (Trial Version 2)" . Therefore, standardizing the operation process of the 2019-nCoV nucleic acid detection in clinical laboratories has become a top priority. It is of paramount importance to establish standard protocols for detection of the 2019-nCoV nucleic acids in clinical laboratories to improve the reliability of the results and ensure the biosafety of laboratory personnel.

Biosafety Consensus for 2019 Novel Coronavirus Pneumonia in Clinical Laboratory / 中华检验医学杂志

With the outbreak and spread of the 2019 Novel Coronavirus pneumonia, laboratory biosafety has become increasingly prominent. The Society of Laboratory Medicine of Chinese Medical Association formulates this guideline with reference to Chinese National Recommendations and relevant documents. From the perspectives of Microbiology, Epidemiology, Case Definition, Safety Principles, Personal Precaution, Specimen Collection, Specimen Transport, Specimen Handling, Analysis, Post-Analysis and Emergencies, this guideline gives recommendations on biosafety precaution and biosafety protection. We hope that it can be practically implemented and continuously improved to ensure laboratory safety.

Coronavirus in pediatrics: report of two cases and review of the literature / Coronavírus na pediatria: relato de dois casos e revisão da literatura

ABSTRACT COVID-19 was identified on December 31, 2019 in China, and has since been the subject of several studies. In the area of pediatrics, the infection appears to affect this population group more mildly when compared to adults. The present work shows the report of two cases of in patients in the pediatric age group, both aged 2 years, presenting their laboratory, clinical and radiological aspects. In this population, the virus's transmissibility seems to be related to symptom presentation, as the less symptomatic the patient presents the lower is transmissibility. The final interest of the presented cases is to demonstrate the good evolution that both patients in the pediatric age group showed, directing attention to the normality of laboratory tests and the presentation with a wide variety of differential diagnoses.

RESUMEN La Covid-19 fue identificada el 31 de diciembre de 2019 en China y ha estado bajo investigación desde entonces. La infección parece transcurrir de forma más leve en niños que en adultos. El presente trabajo muestra el reporte de dos casos de la infección con pacientes en la franja de edad pediátrica, ambos con 2 años de edad, presentando sus aspectos clínicos, radiológicos y de laboratorio. En esta población, es posible que la transmisibilidad del virus esté relacionada con la presentación de síntomas, ya que los pacientes menos sintomáticos tienen menor transmisibilidad. El interés final de los casos presentados es demostrar la buena evolución que ambos pacientes en el rango de edad pediátrico tuvieron, llamando atención para la normalidad de los testes de laboratorio y la presentación con gran variedad de diagnósticos diferenciales.

RESUMO A COVID-19 foi identificada no dia 31 de dezembro de 2019 na China e, desde então, tem sido objeto de diversos estudos. Na área da pediatria, a infecção parece afetar mais suavemente esse grupo populacional em comparação com os adultos. O presente trabalho apresenta o relato de dois casos de pacientes na faixa etária pediátrica, ambos com 2 anos de idade, mostrando seus aspectos laboratoriais, clínicos e radiológicos. Nessa população, a transmissibilidade do vírus parece estar relacionada com a apresentação dos sintomas, pois quanto menos sintomático o paciente se apresenta, menor a transmissibilidade. O interesse final dos casos relatados é demonstrar a boa evolução que os dois pacientes na faixa etária pediátrica apresentaram, direcionando a atenção para a normalidade dos exames laboratoriais e a apresentação com uma grande variedade de diagnósticos diferenciais.

Coronavirus in a patient with hepatitis C: case report / Coronavírus em paciente portador de hepatite C: relato de caso

ABSTRACT In February 2020, the World Health Organization (WHO) named the infection with the new coronavirus, which appeared in December 2019 in China, as Covid-19, and defined it as a worldwide pandemic. There is not much evidence about the relationship between liver disease and Covid-19. Laboratory tests have played a fundamental role in confirming Covid-19, what is usually done by the polymerase chain reaction (PCR) sample. The present study reports the laboratory aspects of a patient with type C hepatitis diagnosed with Covid-19 with an unfavorable evolution, devoting special attention to laboratory tests that were almost normal.

RESUMEN En febrero de 2020, la Organización Mundial de la Salud (OMS) nombró a la infección por el nuevo coronavirus, que surgió en diciembre de 2019 en China, Covid-19, declarándola como pandemia mundial. No hay mucha evidencia sobre la relación entre enfermedades hepáticas y la Covid-19. Las pruebas de laboratorio han ocupado un lugar fundamental para confirmar la infección, lo que generalmente se hace por la muestra de reacción en cadena de la polimerasa (PCR). El presente estudio reporta los aspectos de laboratorio de un paciente con hepatitis C y diagnóstico de Covid-19 con evolución desfavorable, llamando la atención sobre pruebas de laboratorio con resultados casi normales.

RESUMO Em fevereiro de 2020, a Organização Mundial da Saúde (OMS) chamou a infecção pelo novo coronavírus, que surgiu em dezembro de 2019 na China, de COVID-19, definindo-a como pandemia mundial. Não há muitas evidências sobre a relação das doenças hepáticas e a COVID-19. Os exames laboratoriais vêm exercendo um papel fundamental na confirmação da infecção, que é feita geralmente pela amostra de reação em cadeia da polimerase (PCR). O presente estudo relata os aspectos laboratoriais de um paciente portador de hepatite do tipo C e diagnóstico de COVID-19 com evolução desfavorável, dando atenção especial para exames laboratoriais que estavam pouco alterados.

Brief talk about concept of planning and design in medical laboratory / 中华检验医学杂志

In pace with the progressing and strengthening of administration requirement in standardization, biosafety, and third party accreditation for medical laboratories, internal and external environment itself are becoming important elements for total quality control. Laboratory management starts at planning and design. Making the six conceptions (normalization, safety, practicability, convenience, environment-friendliness, and good-looking) as the forerunners, taking more attention to and perfecting most of the details in the phase of planning and designing of a medical laboratory are therefore offered. The aims of informatization, automation, intellectualization, and hommization would be materialized through normatively partitioning clean, buffer and polluted areas, reasonably arranging the passageways of staff, stuff, air and information, and centrally laying out the electric, water, gases, air-condition, and monitoring, which would lay the good foundation for afterwards use and management of the laboratory.

Establishment and application of autoverification procedure for clinical chemistry test results / 中华检验医学杂志

Objective@#To develop autoverification rules to assistant the verification of biochemical results, based on laboratory information management system. @*Methods@#Designed six kinds of autoverification logic rules according to the guidelines of Clinical and Laboratory Standards Institute (CLSI) AUTO-10A and Accreditation Criteria for the Quality and Competence of Medical Laboratories(ISO15189: 2012), based on in-control of the Internal Quality Control. Those rules inculds: logic disorder rules, critical value rules, warning value rules, delta check rules, relevant contradictions rules, abnormal mode rules, etc. Those rules was setted up in laboratory information management system of Dian Diagnostics. From October 2016 to April 2017, The status of autoverification was checked according to the items and bar code, and compared with clinical diagnostic and manual review. @*Results@#The passing rate of autoverification is over 65% when counted according to tests and is 45% when counted according to sample code, the coincidence rate is 92% with clinical diagnosis.In passing results of autoverification, the coincidence rate is 97.48% to 100% when campared with manual verification, and in not-passing results, the coincidence rate is 82.98% to 85.21%. @*Conclusion@#(1)Autoverification can verify half of routine biochemical test results by setting intelligent logics and rules. (2)Autoverification rules must be verified by a certain amount of test results before they can be formally applied. (3)Autoverification could improve the speed and efficiency of post-test steps.(Chin J Lab Med, 2018, 41: 547-553)

Investigation on reasons of unacceptable external quality assessment results for HbA1c in China in 2017 / 中华检验医学杂志

Objective To investigate the reasons of unacceptable external quality assessment results for hemoglobin A1c (HbA1c), and improve quality level.Methods At the end of February 2017, five samples of HbA1c for external quality assessment (EQA) were sent to participated laboratories by post.After testing and reporting results by laboratories , the EQA organizer made statistical analysis and sent results back to laboratories.Meanwhile , messages would be sent to participants those had unacceptable EQA results . Investigating reasons of unacceptable results in 2017 through the EQA System based on web , which was developed by National Central for Clinical Laboratories , calculating the failure rate , analyzing the concrete reasons and combining EQA failure rates with current coefficient of variation .Results The EQA failure rate on HbA1c was 11.2％and reporting rates of reasons for failures was 70.4％(126/179).In the reasons for unacceptable results , technological (27.8％,35/126) and equipment's defects (26.2％,33/126) were the main reason categories , while malfunction ( 12.7％, 16/126 ) and methods defection ( 10.3％, 13/126 ) were the main reason subclass .The unexplainable results after survey account for 8.7％( 11/126 ) .In the group for coefficient of variation ( CV ) over 2％, the percentage of laboratories that had five samples get acceptable results was higher than that of group for CV less than 2％,and the percentage of laboratories that had at most four samples get acceptable results was lower than that of group for CV less than 2％.Conclusions The result of the reasons of unacceptable external quality assessment results for HbA 1c is generally satisfactory.The laboratory, manufacturer and EQA organizers should find and solve the working problems by analyzing EQA data , to improve the testing quality.

Ensino de técnicas de cirurgia cardiovascular na graduação em Medicina utilizando vísceras de suínos / Teaching techniques in cardiovascular surgery for undergraduate students with swine thoracic viscera

OBJETIVO: Apresentar um método prático de ensino e avaliar o grau de eficácia do aprendizado, comparando alunos que passaram pelo curso durante a graduação básica (sétimo semestre) e após 18 meses (décimo semestre), já no internato hospitalar. MÉTODOS: As vísceras conservadas por refrigeração, com coração, estruturas vasculares do mediastino, traqueia e pulmões, foram fixadas em suporte metálico apropriado. Os vasos supra- -aórticos foram ligados, e uma sonda de Foley foi introduzida retrogradamente para a infusão de água, permitindo a apresentação de procedimentos operatórios. Foram aplicados questionários a 40 alunos do sétimo e décimo semestre. As respostas foram submetidas à análise estatística. RESULTADOS: Foram demonstradas técnicas necessárias para o estabelecimento de circulação extracorpórea, confecção de enxerto aorta-coronária com segmento da artéria carótida obtido no mesmo bloco de vísceras, substituição da valva aórtica por prótese valvar sintética, correção de defeito previamente realizado no septo atrial, posicionamento dos vários tipos de eletrodos utilizados para a estimulação elétrica do coração, demonstração de técnicas empregadas para transplante cardíaco, simulação e correção de ferimentos do coração e da aorta. O grau de adequação da ferramenta avaliada foi positivo, com valores entre 55 e 95%, e houve retenção dos ensinamentos após 18 meses. Conclusão: Este método de ensino foi de fácil preparação e baixo custo, permitindo a realização de operações complexas e despertando interesse durante a graduação em Medicina.(AU)

OBJECTIVE: To present this practical teaching method, and assess the degree of learning effectiveness, comparing students who attended the course during basic undergraduation (seventh semester), and after eighteen months (tenth semester), when already in the Hospital internship. METHODS: Thoracic viscera, with heart, vascular structures of the mediastinum, trachea and lungs, preserved by refrigeration, were fixed in a metallic device. The supra-aortic branches were connected, and a Foley catheter was introduced backwards for water infusion, allowing the presentation of surgical procedures. Questionnaires were applied to 40 students of the seventh and tenth semesters; the answers underwent statistical analysis. RESULTS: The following techniques were demonstrated: establishment of cardiopulmonary bypass; coronary artery bypass grafting with carotid artery segment obtained in the same block of viscera; aortic valve replacement with synthetic valve; patch made with biological material in order to correct a defect previously held in the atrial septum; positioning of the various types of electrodes used for electrical stimulation of the heart; demonstration of techniques performed in cardiac transplantation and simulation and correction of both heart and aorta injuries. The degree of adequacy of such tool was positive, with values between 55 and 95%, and retention of what was taught after 18 months. CONCLUSION: This teaching method requires easy preparation and low cost, allowing the performance of complex operations, attracting medical students' interest.(AU)

Blood lipid frofiling and management in clinical laboratory / 中华检验医学杂志

High-fat diet has led to rapid increase in population withdyslipidemia due to the improvement of living standard, which has seriously endangished people′s health.Blood lipid examination is the an important method to diagnose and monitordyslipidemia.Precision detection and proper management can effectively help doctor to diagnose and treat dyslipidemia.This article mainly introduced international and domestic guidelines about dyslipidemia and related progress as well as highlightin this field.Meanwhile, we provided several advices on dyslipidemia from various perspectives.Clinical laboratory related personnel should analyze the influenced factors on blood lipid test examination at pre-test, on-test and post-test and providebetter detection and managementfor blood lipid.

Precision medicine and standardization of clinical laboratories / 中华检验医学杂志

Diverse technological advances in laboratory testing like DNA sequencing,have played important roles at the beginning of precision medicine.And the development of precision medicine will also require the advances of laboratory testing.However,with more new methods and biomarkers applied in clinical practice,the standardization of clinical laboratories testing is confronting great challenges.We will discuss the key challenges related to standardization of commercial reagents or systems and clinical tests,such as the choice of biomarkers,laboratory-developed tests and interpretation and reporting of the results.

The application of sigma metrics quality models in quality management of clinical biochemistry laboratory / 中华检验医学杂志

Objective To improve the quality of clinical biochemistry laboratory by quality indicators of pre-analytical,analytical,post-analytical phase and the whole process.Methods Analytical Phase:The Sigma values of items were calculated,applying the equation Sigma =(TEa％-Bias％)/CV％.Total allowable error (TEa) is from analyticalal specification defined in WS/T403-2012 of China,Bias％ is from the evaluation results of National Center for Clinical Laboratory (NCCL) trueness verification PT series and CV％ is from internal quality control data during the last 6 months in our lab.Normalized Sigma metrics plot was made to evaluate the analysis performance and the quality control strategies were designed accordingly.The quality goal indexes (QGI) were also calculated to propose improvement measures for items below 6 Sigma.Quality indicators of pre-,post-analytical and whole analytical phase,such as quality of specimen,critical value notification,critical value notification in time,TAT of hs-cTnT,TAT of emergency biochemical items,rewrite of laboratory reports and unacceptable performance in EQA-PT were measured in Sigma metrics too.The Sigma metrics changes before and after taking improvement measures were compared to conform the effectiveness.Results The average Sigma value of 17 biochemical tests was 5.29,of which 8 items (UA,K,ALP,CK,AMY,AST,TG,Na) achieved excellent to world class level (≥ 5 Sigma),6 items (LDH,Cre,TC,ALT,Mg,Glu) achieved marginal to good level (5 ＞ Sigma ≥ 3),BUN performed poorly (3 ＞ Sigma ≥ 2),Ca,TP performed unacceptably (Sigma ＜ 2) with serious quality defects.The Sigma values of unacceptable specimen,critical value notification,critical value notification in time,unacceptable turn around time (TAT) of hs-cTnT,unacceptable turn around time (TAT) of emergency biochemical items,rewrite of laboratory reports,unacceptable performance in EQA-PT were 4.17,3.60,2.75,1.72,3.27,4.52,3.33 respectively,rising to 4.30,4.30,2.90,2.45,3.75,4.80,3.60 accordingly after improvement.Conclusions Sigma metrics is potentially an ideal approach for clinical biochemistry laboratories management,which is helpful to find out problems,put forward improvement measures,and confirm the effectiveness,so as to achieve the purpose of continuous quality improvement.

Evaluation of the targeted uncertainty in routine coagulation assay using EQA data / 中华检验医学杂志

Objective To establish the target measurement uncertainty(MU)of the routine coagulation assay according to the External Quality Assessment data(EQA)of routine coagulation assay. Methods Beijing Center for Clinical Laboratory(BCCL)established the target measurementuncertainty for routine coagulation assayswith the"up-down"methodon the basis of 93 clinical laboratoriesEQA datain BeijingThese assays includedActivated partial thromboplastine time(APTT), Fibrinogen(FBG), International Normalized Ratio(INR), Prothrombin time(PT), Thrombin time(TT)and D-dimer, Compared with CLIA′88,the proficiency of current coagulation assayswas observed.Results The MU of six routine coagulation assayscompared with CLIA ′88 showed that: The 90th percentile MU met the creteriain APTTof group B,FBG of group A&B&C,INR of group B and D-dimer of group B.The 75th percentile MU met the creteriainINR of group A&C,PT of group C.The medium met the creteriainAPTT of group A&C,PT of group A and INR of group D.Conclusions Target Measurement Uncertainty was establishedin routine coagulation assay by using EQA data only,whichcan simplify the procedure of determining MU and continuously update MU according to the frequency of EQA.It has good clinical practical value.However, the applicability of this method should also be considered.

Understanding and implementing of individualized quality control plan / 中华检验医学杂志

Accurate results in clinical laboratory are extremely important for patient safety.Quality control is the effective method to control the quality of testing process and ensure the patient safety.With the development of detection technology, the concept of quality control has changed.Clinical Laboratory Standards Institute(CLSI)has established a committee to formulate guidelines for quality control plan based on risk management in the laboratory, using the technology of risk management to develop individualized quality control plan.This article will introduce the understanding and practice of individualized quality control plan.

Implementation of criteria for automatic release of clinical chemistry test results in a laboratory at an academic public hospital / Implantação de critérios de liberação automática de resultados de bioquímica em um laboratório de hospital público universitário

ABSTRACT Introduction: Autoverification is the release of laboratory test results from clinical instruments to hospital interface, or to patients' records, with no human intervention. Verification rules are inserted in the middleware and/or in the laboratory information system (LIS), based on criteria established by the laboratory. As a result, it ensures that every result is consistently reviewed in the same way, improving the entire verification process and patient safety. Objective: Describe the implementation of autoverification of clinical chemistry tests results at the core laboratory of Hospital das Clínicas da Universidade Federal de Minas Gerais (HC/UFMG), Brazil. Material and methods: Twenty-six automated chemistry assays were chosen. They were fully automated including internal quality control, interfaced with LIS, available 24 hours a day, seven days a week. Rules were set up in the middleware and in the LIS. Instrument flags, evaluation of sample integrity, test linearity, delta check and critical values were used to construct the verification algorithms. Results: An autoverification algorithm was constructed; delta check values were calculated and defined, as well as automatic verification ranges. The results retained for manual verification followed a flowchart prepared for this purpose. Conclusion: Autoverification implementation led to a more consistent reviewing process of test results, efficiency and improved patient safety.

RESUMO Introdução: A verificação automática dos resultados consiste na liberação dos resultados dos exames diretamente do equipamento, sem intervenção humana. São inseridas regras para avaliar os resultados no middleware e/ou no sistema de informação laboratorial (SIL), com base em critérios estabelecidos pelo laboratório. A autoverificação uniformiza os critérios de liberação e melhora a eficiência no processo, garantindo a segurança do paciente. Objetivo: Descrever a implantação da autoverificação nos testes bioquímicos do menu de urgência no Serviço de Medicina Laboratorial (SML) do Hospital das Clínicas da Universidade Federal de Minas Gerais (HC/UFMG). Material e métodos: Foram configurados 26 testes bioquímicos disponíveis 24 horas por dia, plenamente interfaceados, inclusive o controle interno da qualidade. Definiram-se parâmetros e algoritmos usados para configuração do SIL e no middleware. No algoritmo elaborado para autoverificação, foram incluídos flags de equipamento, presença de interferentes na amostra, linearidade, delta check e valores críticos. Resultados O algoritmo de liberação automática de resultados, os valores de delta check, os intervalos de liberação automática e o fluxograma para liberação manual dos resultados retidos foram definidos e implantados. Conclusão: A implantação da autoverificação nos testes bioquímicos do menu de urgência no serviço possibilitou padronização e segurança na liberação dos resultados.