Karl Landsteiner Institute for Clinical Risk Management, Vienna, Austria.
Abbott GmbH, Wiesbaden, Germany.
Clin Chem Lab Med. 2022 Mar 28;60(6):830-841. doi: 10.1515/cclm-2021-1349. Print 2022 May 25.
Medical laboratory performance is a relative concept, as are quality and safety in medicine. Therefore, repetitive benchmarking appears to be essential for sustainable improvement in health care. The general idea in this approach is to establish a reference level, upon which improvement may be strived for and quantified. While the laboratory community traditionally is highly aware of the need for laboratory performance and public scrutiny is more intense than ever due to the SARS-CoV-2 pandemic, few initiatives span the globe. The aim of this study was to establish a good practice approach towards benchmarking on a high abstraction level for three key dimensions of medical laboratory performance, generate a tentative snapshot of the current state of the art in the region of Europe, Middle East, and Africa (EMEA), and thus set the stage for global follow-up studies.
The questionnaire used and previously published in this initiative consisted of 50 items, roughly half relating to laboratory operations in general with the other half addressing more specific topics. An international sample of laboratories from EMEA was approached to elicit high fidelity responses with the help of trained professionals. Individual item results were analyzed using standard descriptive statistics. Dimensional reduction of specific items was performed using exploratory factor analysis and assessed with confirmatory factor analysis, resulting in individual laboratory scores for the three subscales of "Operational performance", "Integrated clinical care performance", and "Financial sustainability".
Altogether, 773 laboratories participated in the survey, of which 484 were government hospital laboratories, 129 private hospital laboratories, 146 commercial laboratories, and 14 were other types of laboratories (e.g. research laboratories). Respondents indicated the need for digitalization (e.g. use of IT for order management, auto-validation), automation (e.g. pre-analytics, automated sample transportation), and establishment of formal quality management systems (e.g. ISO 15189, ISO 9001) as well as sustainably embedding them in the fabric of laboratory operations. Considerable room for growth also exists for services provided to physicians, such as "Diagnostic pathways guidance", "Proactive consultation on complex cases", and "Real time decision support" which were provided by less than two thirds of laboratories. Concordantly, the most important kind of turn-around time (TAT) for clinicians, sample-to-result TAT, was monitored by only 40% of respondents.
Altogether, the need for stronger integration of laboratories into the clinical care process became apparent and should be a main trajectory of future laboratory management. Factor analysis confirmed the theoretical constructs of the questionnaire design phase, resulting in a reasonably valid tool for further benchmarking activities on the three aimed-for key dimensions.
医学实验室的表现是一个相对的概念，就像医学中的质量和安全一样。因此，重复性基准测试似乎对于医疗保健的可持续改进至关重要。这种方法的总体思路是建立一个参考水平，在此基础上可以努力提高和量化。虽然实验室界传统上高度意识到实验室表现的必要性，而且由于 SARS-CoV-2 大流行，公众的审查比以往任何时候都更加严格，但很少有举措能够覆盖全球。本研究的目的是为医疗实验室表现的三个关键维度建立一个高层次的基准测试的良好实践方法，生成欧洲、中东和非洲（EMEA）地区当前现状的初步快照，并为全球后续研究奠定基础。
使用的问卷曾在本倡议中发表，共包含 50 个项目，大约一半与实验室的一般运作有关，另一半则涉及更具体的主题。利用受过培训的专业人员的帮助，向来自 EMEA 的国际实验室样本征集高保真度的回复。使用标准描述性统计方法分析单个项目的结果。使用探索性因素分析对特定项目进行维度缩减，并使用验证性因素分析进行评估，从而为“运营绩效”、“综合临床护理绩效”和“财务可持续性”三个子量表生成各个实验室的分数。
共有 773 家实验室参与了这项调查，其中 484 家是政府医院实验室，129 家是私人医院实验室，146 家是商业实验室，还有 14 家是其他类型的实验室（如研究实验室）。受访者表示需要数字化（例如，使用 IT 进行订单管理、自动验证）、自动化（例如，预分析、自动化样本运输）以及建立正式的质量管理体系（例如，ISO 15189、ISO 9001），并将其可持续地融入实验室运营中。向医生提供的服务也有很大的发展空间，例如“诊断途径指导”、“对复杂病例的主动咨询”和“实时决策支持”，不到三分之二的实验室提供这些服务。相应地，临床医生最重要的周转时间（TAT），即样本到结果的 TAT，只有 40%的受访者监测。
总的来说，实验室与临床护理过程更紧密地结合的需求变得明显，这应该成为未来实验室管理的主要轨迹。因子分析证实了问卷设计阶段的理论结构，为进一步在三个目标关键维度上进行基准测试提供了一个合理有效的工具。
