Evaluation of preanalytical and postanalytical phases in clinical biochemistry laboratory according to IFCC laboratory errors and patient safety specifications

IntroductionThe aim of the study was to determine the current state of laboratory’s extra-analytical phase performance by calculating preanalytical and postanalytical phase quality indicators (QIs) and sigma values and to compare obtained data according to desired quality specifications and sigma values reported by The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Working Group – Laboratory errors and Patient Safety.Materials and methodsPreanalytical and postanalytical phase data were obtained through laboratory information system. Rejected samples in preanalytical phase were grouped according to reasons for rejection and frequencies were calculated both monthly and for 2019. Sigma values were calculated according to “short term sigma” table.ResultsThe number of rejected samples in laboratory was 643 out of 191,831 in 2019. Total preanalytical phase rejection frequency was 0.22%. According to the reasons for rejection, QIs and sigma values were: “Samples with excessive transportation time”: 0.0036 and 5.47; “Samples collected in wrong container” 0.02 and 5.11. In December, QIs and sigma values were: “Samples with excessive transportation time”: 0.01 and 5.34; “Samples collected in wrong container”: 0.03 and 4.98. The postanalytical QIs and sigma values were: “Reports delivered outside the specified time”: 0.34 and 4.21; “Turn around time of potassium”: 56 minute and 3.84, respectively. There were no errors in “Critical values of inpatients and outpatients notified after a consensually agreed time”.ConclusionsExtra-analytical phase was evaluated by comparing it with the latest quality specifications and sigma values which will contribute to improving the quality of laboratory medicine.     

Harmonization of pre-analytical quality indicators

Quality indicators (QIs) measure the extent to which set targets are attained and provide a quantitative basis for achieving improvement in care and, in particular, laboratory services. A body of evidence collected in recent years has demonstrated that most errors fall outside the analytical phase, while the pre- and post-analytical steps have been found to be more vulnerable to the risk of error. However, the current lack of attention to extra-laboratory factors and related QIs prevent clinical laboratories from effectively improving total quality and reducing errors. Errors in the pre-analytical phase, which account for 50% to 75% of all laboratory errors, have long been included in the ‘identification and sample problems’ category. However, according to the International Standard for medical laboratory accreditation and a patient-centered view, some additional QIs are needed. In particular, there is a need to measure the appropriateness of all test request and request forms, as well as the quality of sample transportation. The QIs model developed by a working group of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) is a valuable starting point for promoting the harmonization of available QIs, but further efforts should be made to achieve a consensus on the road map for harmonization.     

现有实验室管理模式存在的问题与解决方案

现在大部分高校管理和建设实验室仍然以各系或教研室为单位,规模小,功能单一,易照成重复建设,设备使用率不高。这种模式已经不能适应现今高校发展的趋势,需要改变管理模式。文章提出了改革实验室管理模式的新思路:利用网络等技术手段实现集中管理、高效管理。并提出了具体的改革方法:借助网络技术把地理位置分散的实验室连接起来成为一个整体,并在此基础上开发相应的管理系统提高实验室的通用性和管理水平。为培养学生综合素质和创新能力创造良好的实践场所,进一步挖掘实验室的教学潜力。     

The rise in preanalytical errors during COVID-19 pandemic

IntroductionThe COVID-19 pandemic has posed several challenges to clinical laboratories across the globe. Amidst the outbreak, errors occurring in the preanalytical phase of sample collection, transport and processing, can further lead to undesirable clinical consequences. Thus, this study was designed with the following objectives: (i) to determine and compare the blood specimen rejection rate of a clinical laboratory and (ii) to characterise and compare the types of preanalytical errors between the pre-pandemic and the pandemic phases.Materials and methodsThis retrospective study was carried out in a trauma-care hospital, presently converted to COVID-19 care centre. Data was collected from (i) pre-pandemic phase: 1^st October 2019 to 23^rd March 2020 and (ii) pandemic phase: 24^th March to 31^st October 2020. Blood specimen rejection rate was calculated as the proportion of blood collection tubes with preanalytical errors out of the total number received, expressed as percentage.ResultsTotal of 107,716 blood specimens were screened of which 43,396 (40.3%) were received during the pandemic. The blood specimen rejection rate during the pandemic was significantly higher than the pre-pandemic phase (3.0% versus 1.1%; P < 0.001). Clotted samples were the commonest source of preanalytical errors in both phases. There was a significant increase in the improperly labelled samples (P < 0.001) and samples with insufficient volume (P < 0.001), whereas, a significant decline in samples with inadequate sample-anticoagulant ratio and haemolysed samples (P < 0.001).ConclusionIn the ongoing pandemic, preanalytical errors and resultant blood specimen rejection rate in the clinical laboratory have significantly increased due to changed logistics. The study highlights the need for corrective steps at various levels to reduce preanalytical errors in order to optimise patient care and resource utilisation.     

Contamination of lithium heparin blood by K2-ethylenediaminetetraacetic acid (EDTA): an experimental evaluation

Introduction:

The contamination of serum or lithium heparin blood with ethylenediaminetetraacetic acid (EDTA) salts may affect accuracy of some critical analytes and jeopardize patient safety. The aim of this study was to evaluate the effect of lithium heparin sample contamination with different amounts of K₂EDTA.

Materials and methods:

Fifteen volunteers were enrolled among the laboratory staff. Two lithium heparin tubes and one K₂EDTA tube were collected from each subject. The lithium-heparin tubes of each subject were pooled and divided in 5 aliquots. The whole blood of K₂EDTA tube was then added in scalar amount to autologous heparinised aliquots, to obtained different degrees of K₂EDTA blood volume contamination (0%; 5%; 13%; 29%; 43%). The following clinical chemistry parameters were then measured in centrifuged aliquots: alanine aminotranspherase (ALT), bilirubin (total), calcium, chloride, creatinine, iron, lactate dehydrogenase (LD), lipase, magnesium, phosphate, potassium, sodium.

Results:

A significant variation starting from 5% K₂EDTA contamination was observed for calcium, chloride, iron, LD, magnesium (all decreased) and potassium (increased). The variation of phosphate and sodium (both increased) was significant after 13% and 29% K₂EDTA contamination, respectively. The values of ALT, bilirubin, creatinine and lipase remained unchanged up to 43% K₂EDTA contamination. When variations were compared with desirable quality specifications, the bias was significant for calcium, chloride, LD, magnesium and potassium (from 5% K₂EDTA contamination), sodium, phosphate and iron (from 29% K₂EDTA contamination).

Conclusions:

The concentration of calcium, magnesium, potassium, chloride and LD appears to be dramatically biased by even modest K₂EDTA contamination (i.e., 5%). The values of iron, phosphate, and sodium are still reliable up to 29% K₂EDTA contamination, whereas ALT, bilirubin, creatinine and lipase appear overall less vulnerable towards K₂EDTA contamination.     

Information management of medical errors in Greece: The MERIS proposal

There is a substantial amount of public concern about patient safety, as, according to estimates from major studies, hundreds of thousands die in hospitals each year all over the developed world as a result of medical errors that could have been prevented. Unprecedented research commissioned by the EU has found that almost one out of every four families has experienced a serious medical error. Greek citizens concerning about serious medical errors in the hospital environment, were at the top of the list. Greek Ombudsman's report on medical errors has raised the debate among health policy makers as to the appropriate response to the problem. Proposals range from the implementation of nationwide mandatory reporting with public release of performance data, to voluntary reporting and quality-assurance efforts that protect the confidentiality of error-related data. Any successful safety program will first require a national effort to make significant investments in information systems, along with providing an environment and education that enables to contribute to an active quality improvement process. In this paper we propose the development and implementation of Medical Error Reporting Information System (MERIS), in order to identify, collect, analyse and report medical errors and patient adverse events, as a tool for enhancing patient safety and health care quality. We also describe the necessary organisational structure and the infrastructure environment of the system and the barriers to its successful implementation.     

高校服务质量管理体系构建研究——基于TQM视角

高校为了自身生存竞争与发展,必须建立并完善其质量管理体系。将全面质量管理与ISO9000两者结合起来,设计了高校质量管理体系的过程模式,即管理职责、资源管理、服务实现、测量分析和改进;提出了高校质量管理体系构建的一般程序：质量管理体系策划和设计、质量体系文件的编制、体系的运行与完善。为高校服务质量管理体系的构建和完善提供了重要思路。     

水质实验室的建设和管理

我国淡水资源短缺,仅为世界人均占有量的28%;水资源浪费严重,农业用水量占90%以上;水质污染严重,我国江河湖库淡水普遍受到了污染,甚至严重污染。因此建设水质实验室,有效、快速、准确地检测水质状况,保护广大人民群众的身体健康和生态环境是非常重要的。     

安全标识在实验室安全管理中的发展和应用

安全标识作为实验室安全管理过程中最后一道防线,为保障实验员的人身安全和预防实验室安全事故的发生起着最直接最有效的作用。文章分析了国内外高校实验室安全标识的使用现状,有针对性地整理设计了适合实验室应用的安全标识,并且提出了配备实验室安全标识应用的其他措施。安全标识为"和谐实验室"的安全管理和广大师生的人身安全提供了基本保障。     

基于网格化管理的高校实验室安全管理体系建设探索--以青岛农业大学为例

安全是高校实验室管理的前提和基础。该文结合青岛农业大学实验室安全管理现状,为进一步增强实验室安全管理的准确性和有效性,对该校实验室安全网格化管理体系进行了完善,创新性地提出了“安全监管楼长负责制”理念,并针对该校实验室安全工作总结了几点经验和建议。     

试论企业全面环境友好管理

可持续发展是人类面临的一个重大问题，用系统的观念，说明了企业和外部环境是相互依存相互依赖的关系；提出了应当用全面环境友好的思想来管理企业，以减少或消除企业对环境的不利影响，以及企业应从生产者和消费者两个角色来贯彻全面环境友好管理；最后，提出了成功实施全面环境管理的支撑体系，来实现企业全面环境友好。     

The response of total testing process in clinical laboratory medicine to COVID-19 pandemic

IntroductionFollowing a pandemic, laboratory medicine is vulnerable to laboratory errors due to the stressful and high workloads. We aimed to examine how laboratory errors may arise from factors, e.g., flexible working order, staff displacement, changes in the number of tests, and samples will reflect on the total test process (TTP) during the pandemic period.Materials and methodsIn 12 months, 6 months before and during the pandemic, laboratory errors were assessed via quality indicators (QIs) related to TTP phases. QIs were grouped as pre-, intra- and postanalytical. The results of QIs were expressed in defect percentages and sigma, evaluated with 3 levels of performance quality: 25^th, 50^th and 75^th percentile values.ResultsWhen the pre- and during pandemic periods were compared, the sigma value of the samples not received was significantly lower in pre-pandemic group than during pandemic group (4.7σ vs. 5.4σ, P = 0.003). The sigma values of samples transported inappropriately and haemolysed samples were significantly higher in pre-pandemic period than during pandemic (5.0σ vs. 4.9σ, 4.3σ vs. 4.1σ; P = 0.046 and P = 0.044, respectively). Sigma value of tests with inappropriate IQC performances was lower during pandemic compared to the pre-pandemic period (3.3σ vs. 3.2σ, P = 0.081). Sigma value of the reports delivered outside the specified time was higher during pandemic than pre-pandemic period (3.0σ vs. 3.1σ, P = 0.030).ConclusionIn all TTP phases, some quality indicators improved while others regressed during the pandemic period. It was observed that preanalytical phase was affected more by the pandemic.     

管理和经济专业模拟实验室管理问题初探

针对如何有效地改进管理和经济专业。实验室管理模式及其模拟实验室正常运转的主要性，从硬件设备、软件环境、人员管理3个方面入手，对模拟实验室存在的问题进行了研究；最后，提出了解决问题的相关方法和对策。     

全面创新管理(TIM):企业创新管理的新趋势--基于海尔集团的案例研究

创新日益正成为企业生存与发展的不竭源泉和动力。在总结国内外理论进展与企业实践调研的基础上，文章提出了创新管理的新趋势——全面创新管理(TIM)的概念，并通过海尔集团的案例从时空维度和要素维度对其内涵进行了阐述。作者认为全面创新管理是新经济时代企业培育核心能力、提高企业创新能力的的必然趋势。     

高校建设科研质量管理体系的实践及研究

建设高校科研质量管理体系,已逐渐成为加强科研项目过程管理、提升科研质量和水平的一项重要举措。本文通过在高校建设科研质量管理体系的实践,提出了贯彻科研质量管理体系标准的过程和方法,并对科研质量管理体系的运行状态和效果进行了研究分析。     

基于全面质量管理的组织变革:一个变革模型

从整体上看,全面质量管理在中国没有突出的成效,其症结主要在于原有组织体系的束缚。因此,深刻认识全面质量管理对传统组织的挑战并据此进行系统的组织变革。从基本概念着手,探讨了全面质量管理对组织的系统要求,并在此基础上提出了全面质量管理视角下的组织变革模型。     

现场测试仪器在岩溶水调查与研究中的必要性及其管理

水环境安全是一个备受关注的全球性问题,各国都在积极进行调查与防治。由于岩溶水的变化特点,必须对其指标进行现场测定,并在其调查、研究中引入新技术、先进测试设备。同时,仪器设备管理应该更加科学化、规范化,保证调查研究的高效性、数据准确性,并节约成本。     

创造力在企业危机管理中的运用——基于危机管理团队(CMT)的研究

首先进行了理论回顾,分析了创造力在企业危机管理团队决策过程中进行运用的可行性;然后分析了企业获得创造力的一般模型和方法;最后根据企业危机管理团队决策的不同步骤的需要设计获得创造力的方法。研究表明,企业危机自身所具有的特点决定了传统决策方法在应对危机时的局限性,创造力在企业危机管理中的运用可以帮助获得符合危机情景的可行的危机处理方案。     

The concurrence of the current postanalytical phase management with the national recommendations: a survey of the Working Group for Postanalytics of the Croatian Society of Medical Biochemistry and Laboratory Medicine

IntroductionThe detection and prevention of errors in the postanalytical phase can be done through the harmonization and standardization of constituent parts of this phase of laboratory work. The aim was to investigate how well the ongoing management of the postanalytical phase corresponds to the document “Post-analytical laboratory work: national recommendations” in Croatian medical biochemistry laboratories (MBLs).Materials and methodsAll 195 MBLs participating in the national external quality assessment scheme, were invited to undertake a part in a survey. Through 23 questions the participants were asked about management of the reference intervals (RI), delta check, reflex/reflective testing, postanalytical quality indicators and other parts of the postanalytical phase recommended in the national recommendations. The results are presented in numbers and percentages.ResultsOut of 195 MBLs, 119 participated in the survey, giving a response rate of 61%. Not all of the respondents provided answers to all the questions. Delta check has not been used in 59% (70/118) of the laboratories. Only 22/113 (20%) laboratories use reflex and/or reflective testing. In 53% of the laboratories, critical results were reported within 30 minutes of the confirmation of the results. In 34% (40/118) of the laboratories, turnaround time and reporting of critical results are two most often monitored postanalytical quality indicators.ConclusionThe results showed the critical results reporting and monitoring of postanalytical quality indicators are in the line with the recommendations. However, the management of RI verification, the use of delta check and reflex/reflective testing still must be harmonized among Croatian MBLs.     

Utilization of biological variation data in the interpretation of laboratory test results – survey about clinicians’ opinion and knowledge

IntroductionTo interpret test results correctly, understanding of the variations that affect test results is essential. The aim of this study is: 1) to evaluate the clinicians’ knowledge and opinion concerning biological variation (BV), and 2) to investigate if clinicians use BV in the interpretation of test results.Materials and methodsThis study uses a questionnaire comprising open-ended and close-ended questions. Questions were selected from the real-life numerical examples of interpretation of test results, the knowledge about main sources of variations in laboratories and the opinion of clinicians on BV. A total of 399 clinicians were interviewed, and the answers were evaluated using a scoring system ranked from A (clinician has the highest level of knowledge and the ability of using BV data) to D (clinician has no knowledge about variations in laboratory). The results were presented as number (N) and percentage (%).ResultsAltogether, 60.4% of clinicians have knowledge of pre-analytical and analytical variations; but only 3.5% of them have knowledge related to BV. The number of clinicians using BV data or reference change value (RCV) to interpret measurements results was zero, while 79.4% of clinicians accepted that the difference between two measurements results located within the reference interval may be significant.ConclusionsClinicians do not use BV data or tools derived from BV such as RCV to interpret test results. It is recommended that BV should be included in the medical school curriculum, and clinicians should be encouraged to use BV data for safe and valid interpretation of test results.