Errors within the total laboratory testing process, from test selection to medical decision-making - A review of causes, consequences, surveillance and solutions
从检验选择到医疗决策的整个实验室检验过程中的错误--原因、后果、监控和解决方案回顾

Keywords: total testing process; extra-analytical phase; quality indicators; laboratory medicine; patient safety
关键词：整个检验过程；分析外阶段；质量指标；检验医学；患者安全

The modern health care is inevitably dependent on laboratory results for diagnosis, prognosis and/ or treatment decisions (1). Therefore, accurate performance of all the steps included within the traditional brain-to-brain loop, i.e., test ordering/testselection, sample collection, identification, transport, sample preparation, analysis, test reporting, interpretation and action is important (2).
现代医疗保健在诊断、预后和/或治疗决策方面不可避免地依赖于实验室结果（1）。因此，准确执行传统的 "脑-脑 "循环中的所有步骤，即化验单/化验选择、样本采集、鉴别、运送、样本制备、分析、化验报告、解释和行动非常重要 (2)。

Unfortunately, each of these steps is vulnerable to errors, which can then potentially generate erroneous results and finally jeopardize patient safety. To mention only a few examples, the specimen may be drawn from the wrong patient; erroneous low calcium and alkaline phosphatase may be misinterpreted when potassium-ethylenediaminetetraacetic acid (K-EDTA) contamination is not identified; pseudohyperkalaemia due to extreme leuco-
不幸的是，这些步骤中的每一步都很容易出错，进而可能产生错误结果，最终危及患者安全。仅举几例：标本可能取自错误的患者；如果没有识别出钾-乙二胺四乙酸（K-EDTA）污染，可能会误读低血钙和碱性磷酸酶；由于极度白细胞减少而导致假性高钾血症；由于没有识别出钾-乙二胺四乙酸污染，可能会误读低血钙和碱性磷酸酶；由于没有识别出钾-乙二胺四乙酸污染，可能会误读低血钙和碱性磷酸酶。
cytosis may lead to unnecessary and even potentially dangerous treatment (3-5).
细胞增多症可能会导致不必要的、甚至是潜在危险的治疗 (3-5)。
There is now incontrovertible evidence that the vast majority of laboratory errors occur in the preanalytical phase (61.9-68.2%), which are then followed by mistakes in the postanalytical (18.5$23.1\mathrm{\%}$$23.1\mathrm{\%}$23.1%23.1 \% ) and analytical (13.3-15%) parts of the total testing process (TTP) (6,7). Using the same study design in 1996 and 2006, Carraro and Plebani attributed the decline of the error rate of samples contaminated by infusion fluids from $20.6\mathrm{\%}$$20.6\mathrm{\%}$20.6%20.6 \% to $1.9\mathrm{\%}$$1.9\mathrm{\%}$1.9%1.9 \% to corrective actions. Together with the statement that $73\mathrm{\%}$$73\mathrm{\%}$73%73 \% of errors in the TTP seem to be preventable, this reinforces the need of vigilance and monitoring of laboratory vulnerability (7).
现在有无可争辩的证据表明，绝大多数实验室错误发生在分析前阶段（61.9%-68.2%），然后是分析后阶段（18.5% $23.1\mathrm{\%}$$23.1\mathrm{\%}$23.1%23.1 \% ）和整个检测过程（TTP）中的分析部分（13.3%-15%）（6,7）。Carraro 和 Plebani 在 1996 年和 2006 年使用相同的研究设计，将受输液污染样本的错误率从 $20.6\mathrm{\%}$$20.6\mathrm{\%}$20.6%20.6 \% 下降到 $1.9\mathrm{\%}$$1.9\mathrm{\%}$1.9%1.9 \% 归因于纠正措施。再加上 TTP 中 $73\mathrm{\%}$$73\mathrm{\%}$73%73 \% 的错误似乎是可以预防的这一说法，更加说明了对实验室薄弱环节保持警惕和监控的必要性 (7)。
As error rates are traditionally reported from blood collection to result reporting, less emphasis has
由于误差率传统上是从采血到结果报告的过程中进行报告的，因此较少强调
been given to appropriateness in test selection, result interpretation and medical action, phases, some authors refer to as “pre-pre”- and “post-post”- analytical phase (8). For an easier understanding, we will refrain from using these terms, since respective processes may be subsumed under the pre- or postanalytical phases. However, laboratory specialists must not neglect these steps of the TTP, whereby many studies show high frequencies of inappropriate test selection and uncertainty in result interpretation (9-11). Moreover, inappropriate test selection seems to be especially more frequent than all other errors that have been identified so far (Figure 1). In this review, we hence want to describe the types and frequencies of errors, which may occur during the TTP (i.e., the brain-to-brain loop), including test selection and interpretation/medical action. Due to different study designs, frequencies of errors are related to heterogeneously acquired data and are therefore not entirely comparable. Nevertheless, to get an overview of the numbers mentioned in the review,
有些作者将这些阶段称为 "前-前 "和 "后-后 "分析阶段（8）。为了便于理解，我们将不使用这些术语，因为相关过程可归入分析前或分析后阶段。然而，实验室专家决不能忽视 TTP 的这些步骤，因为许多研究表明，检验项目选择不当和结果解释不确定的频率很高（9-11）。此外，与迄今为止发现的所有其他错误相比，检验项目选择不当的频率似乎更高（图 1）。因此，在本综述中，我们希望描述在 TTP（即脑到脑循环）过程中可能出现的错误类型和频率，包括试验选择和解释/医疗行为。由于研究设计不同，错误频率与获取的数据也不尽相同，因此不具有完全可比性。尽管如此，为了对综述中提到的数字有一个大致的了解，我们还是对这些数字进行了分析、
we plotted them in figures, separated in percentages related to analyses/tests, survey responders, missed diagnoses of malpractice claims, errors, samples, and phlebotomies of an observational study (Figure 1-6).
我们将其绘制成图，并按百分比分列，涉及分析/测试、调查应答者、渎职索赔的漏诊、错误、样本和观察性研究的抽血（图 1-6）。

Moreover, we aim to provide some suggestions on how these errors can be measured and we will mention some tentative strategies for improvement. In order to provide a quick overview, we additionally summarized these issues in a supplemental table (Appendix 1), categorized by the TTP phase, the TTP step and the sources of error, including respective quality indicators (QI) measurement options as well as possible solutions for improvement.
此外，我们还旨在就如何衡量这些误差提出一些建议，并将提及一些初步的改进策略。为了提供一个快速概览，我们还在补充表格（附录 1）中对这些问题进行了总结，并按照 TTP 阶段、TTP 步骤和误差来源进行了分类，包括相应的质量指标 (QI) 测量选项以及可能的改进方案。

Following the Plan-Do-Check-Act (PDCA) cycle is a widely used tool to improve certain processes (12). Quality control as the “check”-part thereof is es-
遵循 "计划-实施-检查-行动"（Plan-Do-Check-Act，PDCA）循环是改进某些流程的广泛应用工具 (12)。作为其中 "检查 "部分的质量控制是
% related to analyses/tests
与分析/测试有关的百分比

Figure 1. Published data on error rates (reference numbers are indicated in brackets) related to analyses/tests.
图 1.已公布的与分析/测试有关的误差率数据（括号内为参考编号）。
sential to detect error-prone stages of the TTP, which need further improvement activities. The low error rates in the intra-laboratory parts of the TTP can be attributable to the fact that these are under strict control of highly trained laboratory personnel. In addition, the vast majority of laboratories have now implemented a quality management system according to the requirements of ISO 15189, ISO 9001, or other national standards (13,14). An interesting relationship has been published by Buchta et al., who showed that laboratories using an immunohaematology external quality assessment (EQA) scheme with ISO 9001 certification or ISO 15189 accreditation have lower error rates than others (15). However, further studies are needed to evaluate the improvement of error rates by the use of quality management systems. In a recent survey $21\mathrm{\%}$$21\mathrm{\%}$21%21 \% of participating European laboratories admitted that they were not accredited or certified (Figure 2) (16).
这对检测出需要进一步改进的 TTP 中容易出错的阶段至关重要。TTP 实验室内部环节出错率低的原因是，这些环节都是在训练有素的实验室人员的严格控制下进行的。此外，绝大多数实验室目前都已按照 ISO 15189、ISO 9001 或其他国家标准的要求实施了质量管理体系（13,14）。Buchta 等人发表了一篇有趣的关系研究，他们发现，采用 ISO 9001 认证或 ISO 15189 认证的免疫血液学外部质量评估（EQA）计划的实验室比其他实验室出错率更低（15）。然而，还需要进一步的研究来评估使用质量管理体系对出错率的改善作用。在最近的一项调查中， $21\mathrm{\%}$$21\mathrm{\%}$21%21 \% 参与调查的欧洲实验室承认它们没有获得认可或认证（图 2）（16）。

In analogy with the analytical phase, more attention should be paid to quality assessment in the pre- and postanalytical phase (17). One possibility is participating in the model of Qls program, which has been established by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Working Group “Laboratory Errors and Patient Safety” (WG-LEPS) and the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Task and Finish Group “Performance specifications for the extra-analytical phases” (TFG-PSEP). Laboratories can log in for free through the web-portal (www.ifcc-mqi.com), enter local process-specific Qls and benchmark them to other national and international laboratories (18). The proposed Qls, summarized in Appendix 1, span throughout the TTP. Notably, additional programs have been established at the national level, like the German/Austrian Preanalytical Benchmark Database for comparison of haemolysis data (19). The Six Sigma approach would be another way to document and compare errors (20). In addition, the defects per million opportunities (DPMO) should be stated. An improvement of the sigma value from three to four would correspond to a change in DPMO from 66,800 to 6200 and 2700 to
与分析阶段类似，应更加重视分析前和分析后阶段的质量评估（17）。一种可能的方法是参与 Qls 计划模型，该模型由国际临床化学和实验室医学联合会（IFCC）"实验室错误与患者安全 "工作组（WG-LEPS）和欧洲临床化学和实验室医学联合会（EFLM）"分析外阶段的性能规范 "工作组（TFG-PSEP）建立。实验室可通过门户网站（www.ifcc-mqi.com）免费登录，输入本地流程的特定 Qls，并与其他国家和国际实验室进行比对（18）。附录 1 中概述的拟议 Qls 涵盖了整个 TTP。值得注意的是，在国家层面还建立了其他项目，如用于比较溶血数据的德国/奥地利分析前基准数据库（19）。六西格玛方法是记录和比较错误的另一种方法（20）。此外，还应说明每百万次机会的缺陷率（DPMO）。西格玛值从 3 提高到 4 相当于 DPMO 从 66,800 下降到 6200，2700 下降到

63 for long-term and short-term Sigma metric, respectively (21).
长期和短期西格玛指标分别为 63（21）。
Despite these efforts, a recent survey among European laboratories revealed that although the majority of laboratories already document/monitor preanalytical errors, about a third of them fail to evaluate their data and, even when a statistical analysis is made, approximately $25\mathrm{\%}$$25\mathrm{\%}$25%25 \% of them remain inactive against unsatisfactory results (16).
尽管做出了这些努力，但最近对欧洲实验室进行的一项调查显示，尽管大多数实验室已经记录/监控分析前误差，但约有三分之一的实验室未能对其数据进行评估，即使进行了统计分析，约 $25\mathrm{\%}$$25\mathrm{\%}$25%25 \% 的实验室仍对不满意的结果不闻不问（16）。

A recent survey carried out among 1347 European laboratories, categorized responses to the openended question “Which preanalytical topics concern you most?” into three topics: analyte stability, analytical interference (haemolysis, icterus, lipemia (HIL)), and compliance to venous specimen collection guidelines (16). This would hence lead to conclude that laboratories are still focusing on the TTP from “Sample collection” onwards, thus overlooking the first and essential step “Test ordering/test selection”, where laboratory specialists could initiate collaborations with clinicians to overcome inappropriate test requesting habits.
最近对 1347 家欧洲实验室进行了一项调查，将对开放式问题 "您最关心的分析前主题是什么？"的回答分为三个主题：分析物稳定性、分析干扰（溶血、黄疸、脂血（HIL））和遵守静脉标本采集指南（16）。因此，我们可以得出这样的结论：实验室仍然从 "样本采集 "开始就关注 TTP，从而忽略了第一步，也是至关重要的一步 "检验订单/检验选择"，在这一步中，实验室专家可以与临床医生开展合作，克服不恰当的检验申请习惯。
According to the “five rights rule” paradigm, an effective strategy for preventing errors encompasses that the right test must be ordered in the right patient at the right time (22). Evidence that this practice is not thoughtfully followed comes from a survey among 1768 primary care physicians, which revealed uncertainty on test ordering in as many as $15\mathrm{\%}$$15\mathrm{\%}$15%15 \% of respondents (Figure 2) (11).
根据 "五权规则 "范式，预防错误的有效策略包括必须在正确的时间为正确的患者开具正确的检验单（22）。一项对 1768 名初级保健医生进行的调查显示，多达 $15\mathrm{\%}$$15\mathrm{\%}$15%15 \% 的受访者在开具检验单时存在不确定性（图 2）（11）。
Inappropriate use of laboratory tests may present as over- or underutilization. Reasons for overutilization - i.e., ordering tests which are not appropriate - may include the use of routine laboratory ordering panels, non-adherence to re-testing intervals or biological implausibility (9,23,24). An interesting meta-analysis has recently shown that the mean rates of overutilization can be as high as $20.6\mathrm{\%}$$20.6\mathrm{\%}$20.6%20.6 \% (Figure 1) (23). Nevertheless, up to $70\mathrm{\%}$$70\mathrm{\%}$70%70 \% of requests may have questionable clinical significance in single studies $(9,10)$$(9,10)$(9,10)(9,10).
实验室检测使用不当可能表现为过度使用或使用不足。过度使用的原因--即订购不合适的化验项目--可能包括使用常规化验订购单、不遵守再化验间隔时间或生物学上的不靠谱（9,23,24）。最近一项有趣的荟萃分析表明，过度使用的平均比率可高达 $20.6\mathrm{\%}$$20.6\mathrm{\%}$20.6%20.6 \% （图 1）（23）。然而，在单项研究 $(9,10)$$(9,10)$(9,10)(9,10) 中，多达 $70\mathrm{\%}$$70\mathrm{\%}$70%70 \% 的申请可能具有可疑的临床意义。
Underutilization, i.e., failure to order the correct diagnostic test, is comprised within the leading
利用率不足，即未订购正确的诊断检测，主要包括
% related to survey responders
与调查答卷人有关的百分比

Figure 2. Published data on error rates (reference numbers are indicated in brackets) related to survey responders. HIL - haemolysis, icterus, lipemia.
图 2.已公布的与调查应答者有关的误差率数据（括号内为参考编号）。HIL - 溶血、黄疸、脂血。
causes of missed or delayed diagnoses, and should hence be considered a major threat of patient safety (23). In closed malpractice claims, underutilization has been identified as a major contributor
这也是导致漏诊或延误诊断的原因，因此应被视为对患者安全的一大威胁（23）。在已结案的渎职索赔中，使用不足已被确定为主要原因之一。
of missed and delayed diagnoses in up to $55\mathrm{\%}$$55\mathrm{\%}$55%55 \% ambulatory cases, and in up to $58\mathrm{\%}$$58\mathrm{\%}$58%58 \% emergency department cases, respectively (Figure 3) $(25,26)$$(25,26)$(25,26)(25,26). With the limitation of the small number of studies
$55\mathrm{\%}$$55\mathrm{\%}$55%55 \% 门诊病例和 $58\mathrm{\%}$$58\mathrm{\%}$58%58 \% 急诊科病例的漏诊和延误诊断率分别高达 $55\mathrm{\%}$$55\mathrm{\%}$55%55 \% 和 $58\mathrm{\%}$$58\mathrm{\%}$58%58 \% （图 3） $(25,26)$$(25,26)$(25,26)(25,26) 。受研究数量少的限制

Figure 3. Published data on error rates (reference numbers are indicated in brackets) related to missed diagnoses of malpractice claims.
图 3.已公布的与渎职索赔漏诊有关的错误率数据（括号内为参考编号）。
addressing this issue, a meta-analysis published by Zhi et al. concluded that the mean rates of inappropriate underutilization of laboratory tests can approximate 45% (23).
针对这一问题，Zhi 等人发表的一项荟萃分析得出结论，实验室化验不合理使用率的平均值约为 45%（23）。
Specialists in laboratory medicine should acknowledge inappropriate test requests by measuring the corresponding Qls (18). Appropriate solutions may be developed in collaboration with clinicians for reducing the number of inappropriate test requests, by applying one or more efficient strategies, which may include education through feedback, use of interpretive comments, automated flags when tests have no clinical value in the specific setting or are repeated too early, gate-keeping strategies for tests with a high negative predictive value, diagnostic pathways (i.e., “algorithms”) for specific indications/symptoms, implementation of reflex criteria for defined pathological test results, reflective testing or establishment of diagnostic management teams ( $8,10,24,27-32$$8,10,24,27-32$8,10,24,27-328,10,24,27-32 ).
检验医学专家应通过测量相应的 Qls 来确认不适当的检验申请（18）。可与临床医生合作制定适当的解决方案，通过采用一种或多种有效策略来减少不适当检验请求的数量，这些策略可包括通过反馈进行教育、使用解释性评论、当检验在特定情况下无临床价值或过早重复时自动标记、对阴性预测值高的检验采取把关策略、针对特定适应症/症状的诊断路径（即 "算法"）、对确定的病理检验结果实施反射标准、反射检验或建立诊断管理团队（ $8,10,24,27-32$$8,10,24,27-32$8,10,24,27-328,10,24,27-32 ）。
Additional errors within the ordering process may occur during the test requesting procedure itself. The data entry into the hospital information system (HIS) may be incorrect, or the wrong patient may be selected. Test requests can also be misinterpreted, unintelligible or get lost (Figures 4-5) $(6,7,33,34)$$(6,7,33,34)$(6,7,33,34)(6,7,33,34). The use of computerized physician order entry (CPOE) systems coupled with barcodes for patients and blood tubes are advisable for reducing the intrinsic risks associated with paperbased test requests $(33,35)$$(33,35)$(33,35)(33,35).
在申请检查的过程中还可能出现其他错误。输入医院信息系统（HIS）的数据可能不正确，或选择了错误的病人。检验申请也可能被误解、无法理解或丢失（图 4-5） $(6,7,33,34)$$(6,7,33,34)$(6,7,33,34)(6,7,33,34) 。使用计算机化医嘱输入（CPOE）系统，加上病人和血管的条形码，可减少与纸质检验申请相关的内在风险 $(33,35)$$(33,35)$(33,35)(33,35) 。

In this section of the review we will focus on errors potentially occurring during venous blood sampling. A specific discussion on collection of capillary, cerebrospinal fluid, urine and blood culture samples ought to be omitted for space constrains, though information can be garnered elsewhere (36-39).
在本章节中，我们将重点讨论静脉采血过程中可能出现的错误。由于篇幅有限，我们将不对毛细血管、脑脊液、尿液和血培养样本的采集进行具体讨论，但相关信息可从其他地方获取（36-39）。
In 2018 the EFLM Working Group for Preanalytical Phase (WG-PRE) and the Latin American Working Group for the Preanalytical Phase (WG-PRELATAM) of the Latin America Confederation of Clinical Biochemistry (COLABIOCLI) have jointly is-
2018 年，EFLM 分析前阶段工作组（WG-PRE）和拉丁美洲临床生化联合会（COLABIOCLI）的拉丁美洲分析前阶段工作组（WG-PRELATAM）联合开展了一项活动，旨在促进拉丁美洲临床生化联合会（COLABIOCLI）的分析前阶段工作。
sued a Consensus Guideline on venous blood collection, aiming to provide evidence-based guidance on every single step of the phlebotomy process (40).
该指南旨在为抽血过程的每一个步骤提供循证指导（40）。

The accurate identification of the patient and the appropriate labelling of blood collection tubes are crucial steps for preventing diagnostic errors and inappropriate patient management.
准确识别患者身份并在采血管上贴上适当的标签，是防止诊断错误和患者管理不当的关键步骤。
Patient identification should be performed by asking open questions and/or comparing the patient’s identification (barcoded) bracelet using at least two identifiers $(33,41)$$(33,41)$(33,41)(33,41). Collection tubes should be labelled directly before or after phlebotomy, but always in the presence of the patient. In an EFLM WG-PRE observational study, phlebotomists failed to identify the patient according to Clinical and Laboratory Standards Institute (CLSI) or local guidelines in up to $16\mathrm{\%}$$16\mathrm{\%}$16%16 \% of cases. When sample tubes were labelled after phlebotomy, labelling was not carried out in the presence of the patient in nearly one-third of cases (Figure 6) (42). This evidence is then reflected by data on sample rejection for misidentification or receipt of unlabelled tubes, leading to rejection rates as high as $0.2\mathrm{\%}$$0.2\mathrm{\%}$0.2%0.2 \% of all samples (Figure 5) $(34,43,44)$$(34,43,44)$(34,43,44)(34,43,44). As a proportion of errors analysed, patient identification account for approximately 9% (Figure 4) (7).
患者身份识别应通过公开提问和/或使用至少两个识别符 $(33,41)$$(33,41)$(33,41)(33,41) 比较患者的身份识别（条形码）手镯来进行。采血管应在抽血前或抽血后直接贴上标签，但一定要在患者在场的情况下进行。在一项 EFLM WG-PRE 观察性研究中，抽血医师在多达 $16\mathrm{\%}$$16\mathrm{\%}$16%16 \% 的情况下未能根据临床和实验室标准协会 (CLSI) 或当地指南识别患者。抽血后在样本管上贴标签时，近三分之一的病例没有在患者在场的情况下进行（图 6）（42）。这一证据随后反映在因识别错误或收到未贴标签试管而拒收样本的数据中，导致所有样本的拒收率高达 $0.2\mathrm{\%}$$0.2\mathrm{\%}$0.2%0.2 \% （图 5） $(34,43,44)$$(34,43,44)$(34,43,44)(34,43,44) 。在分析的错误比例中，患者身份识别错误约占 9%（图 4）(7)。
Misidentification errors may be surveilled by Qls (18). Most possibilities aiming to reduce identification errors encompass some form of automation: barcoding system for identification and labelling, occasionally with automated systems for labelling of tubes or pre-labelled tubes $(33,35,45)$$(33,35,45)$(33,35,45)(33,35,45).
识别错误可通过 Qls (18) 来监测。大多数旨在减少鉴别错误的方法都包含某种形式的自动化：用于鉴别和标记的条形码系统，有时还有用于标记试管或预先标记试管 $(33,35,45)$$(33,35,45)$(33,35,45)(33,35,45) 的自动化系统。

Collecting blood in a non-fasted state and even chewing of a sugar-free gum may influence laboratory parameters $(46,47)$$(46,47)$(46,47)(46,47). Moreover, the concentration of specific analytes, e.g. catecholamines, may be influenced by the type of aliments ingested recently (48). Information on physical activity, as well as intake of drugs (time, dosage), are also
在非空腹状态下采血，甚至咀嚼无糖口香糖都可能影响实验室参数 $(46,47)$$(46,47)$(46,47)(46,47) 。此外，特定分析物（如儿茶酚胺）的浓度可能会受到最近摄入的食物类型的影响（48）。有关体力活动和药物摄入（时间、剂量）的信息也会影响实验室参数<0>。
% related to errors
与错误有关的百分比

Figure 4. Published data on error rates (reference numbers are indicated in brackets) related to errors.
图 4.已公布的与误差有关的误差率数据（括号内为参考编号）。
important for the accurate interpretation of test results $(40,49)$$(40,49)$(40,49)(40,49). Moreover, patients should rest for at least 15 minutes, either lying or sitting before blood collection $(40,49,50)$$(40,49,50)$(40,49,50)(40,49,50). In special cases, e.g. catecholamines in plasma, these demands may be even more stringent (48).
$(40,49)$$(40,49)$(40,49)(40,49) 。此外，患者在采血前应躺着或坐着休息至少 15 分钟 $(40,49,50)$$(40,49,50)$(40,49,50)(40,49,50) 。在特殊情况下，如血浆中的儿茶酚胺，这些要求可能更加严格（48）。
In a recently published study, Simundic et al. reported that the phlebotomist failed to verify whether the patient was correctly prepared for blood collection in over $31\mathrm{\%}$$31\mathrm{\%}$31%31 \% of samplings (42).
在最近发表的一项研究中，Simundic 等人报告说，在超过 $31\mathrm{\%}$$31\mathrm{\%}$31%31 \% 的采样中，抽血医师未能确认患者是否为采血做好了正确的准备（42）。
Blood samples should be collected in the morning, to prevent the impact of diurnal variation $(46,49)$$(46,49)$(46,49)(46,49). The time of sample collection should always be documented, to verify whether laboratory analyses are performed within the time of stability of the respective parameter.
血液样本应在早晨采集，以防止昼夜变化的影响 $(46,49)$$(46,49)$(46,49)(46,49) 。应始终记录样本采集时间，以核实实验室分析是否在相关参数的稳定时间内进行。
In selected cases (e.g. emergency or outpatient wards) adherence to these recommendations is not always possible in daily routine. Moreover, under defined circumstances, interpretation of certain parameters may even be possible (e.g. lipid results in a non-fasting state) (51). Nevertheless, information about the preparation of the patient should be documented to avoid misinterpretation of results (40).
在某些情况下（如急诊或门诊病房），在日常工作中并非总能遵守这些建议。此外，在特定情况下，甚至可以解释某些参数（如非空腹状态下的血脂结果）（51）。尽管如此，仍应记录患者的准备信息，以避免对结果产生误解（40）。

Blood should never be drawn at the infusion site or proximal thereof. In case intravenous (IV) lines cannot be avoided for blood collection, the flushing of the line and the subsequent discard of a certain blood volume should be carried out correctly $(49,52)$$(49,52)$(49,52)(49,52). The rate of samples rejected for contamination with fluids from intravenous infusions can be as high as $2.2\mathrm{\%}$$2.2\mathrm{\%}$2.2%2.2 \% of overall samples (44).
切勿在输液部位或其近端抽血。在无法避免静脉注射管路采血的情况下，应正确进行管路冲洗并随后丢弃一定量的血液 $(49,52)$$(49,52)$(49,52)(49,52) 。因静脉输液污染而被剔除的样本比例可高达样本总量的 $2.2\mathrm{\%}$$2.2\mathrm{\%}$2.2%2.2 \% (44)。

If venous stasis cannot be avoided, the tourniquet should be released within one minute while the blood is collected into the first tube to avoid alterations due to fluid shifts (49). In the EFLM WG-PRE observational study, it was found that the tourniquet is not released appropriately in $43\mathrm{\%}$$43\mathrm{\%}$43%43 \% of observed blood collections (42). Furthermore, the phlebotomist has to advise the patient not to clench the fist, as this procedure may lead to spurious haemolysis and/or hyperkalaemia (53).
如果无法避免静脉淤血，则应在将血液收集到第一支试管中的同时在一分钟内松开止血带，以避免因体液转移而发生变化（49）。在 EFLM WG-PRE 观察性研究中发现，在 $43\mathrm{\%}$$43\mathrm{\%}$43%43 \% 观察到的采血中，止血带没有被适当松开（42）。此外，抽血医师必须告知患者不要握紧拳头，因为这一过程可能会导致假性溶血和/或高钾血症（53）。

Collecting blood in the appropriate tubes and with the appropriate order of draw is crucial to avoid additive carryover. Potassium-EDTA contamination of heparin samples may result in spurious hyperkalaemia and low concentrations of calcium due to EDTA sequestration (4). Contamination is reported in up to $0.02\mathrm{\%}$$0.02\mathrm{\%}$0.02%0.02 \% of samples received (43). Although following the order of draw is recommended (40), it seems that the risk of contamination has become negligible, especially if closed loop systems are used and recommendations of blood sampling are strictly followed $(54,55)$$(54,55)$(54,55)(54,55).
用适当的试管和适当的抽血顺序采血对于避免添加剂携带至关重要。肝素样本中的钾-EDTA 污染可能会导致假性高钾血症和因 EDTA 封存而导致的低钙浓度（4）。据报道，高达 $0.02\mathrm{\%}$$0.02\mathrm{\%}$0.02%0.02 \% 的样本会受到污染（43）。尽管建议遵循抽血顺序（40），但污染风险似乎已变得微不足道，尤其是在使用闭环系统和严格遵循 $(54,55)$$(54,55)$(54,55)(54,55) 采血建议的情况下。
The use of inappropriate containers accounts for $0.03\mathrm{\%}$$0.03\mathrm{\%}$0.03%0.03 \% to $3.6\mathrm{\%}$$3.6\mathrm{\%}$3.6%3.6 \% of overall sample, or $2.6\mathrm{\%}$$2.6\mathrm{\%}$2.6%2.6 \% to $8.1\mathrm{\%}$$8.1\mathrm{\%}$8.1%8.1 \% of all errors analysed ( $6,7,43,44$$6,7,43,44$6,7,43,446,7,43,44 ). Beside the adoption of educational interventions, this error could be avoided by using automated samples labelling systems (45).
使用不当的容器占样本总数的 $0.03\mathrm{\%}$$0.03\mathrm{\%}$0.03%0.03 \% 至 $3.6\mathrm{\%}$$3.6\mathrm{\%}$3.6%3.6 \% ，或占所有分析误差的 $2.6\mathrm{\%}$$2.6\mathrm{\%}$2.6%2.6 \% 至 $8.1\mathrm{\%}$$8.1\mathrm{\%}$8.1%8.1 \% （ $6,7,43,44$$6,7,43,44$6,7,43,446,7,43,44 ）。除了采取教育干预措施外，还可以通过使用自动标样系统来避免这一错误（45）。

Tubes need to be filled up to the indicated volume, inverted once immediately after blood collection and at least five to ten times, as indicated by manufacturers, at the end of the phlebotomy procedure (40). This practice will prevent rejection of specimen due to clotting. Especially for coagulation assays, correct filling of tubes is essential to ensure an adequate blood/citrate-ratio. The results of the activated partial thromboplastin time (APTT) may already be biased in samples filled to $\le$$\le$<=\leq $90\mathrm{\%}$$90\mathrm{\%}$90%90 \% of the theoretical filling volume (56). In the EFLM WG-PRE observational study, tubes were un-der- or overfilled in $24.2\mathrm{\%}$$24.2\mathrm{\%}$24.2%24.2 \% of cases (42). Laboratories report a wide range of rejected samples due to insufficient sample volume or inadequate sam-ple-anticoagulant ratio (i.e., between 0-34.9%), accounting for up to $13.1\mathrm{\%}$$13.1\mathrm{\%}$13.1%13.1 \% of all errors ( $7,34,43,44$$7,34,43,44$7,34,43,447,34,43,44 ). The aforementioned observational study revealed that $30.4\mathrm{\%}$$30.4\mathrm{\%}$30.4%30.4 \% sample tubes were not correctly mixed (42). Rejection rates due to clotted specimen are reported to involve up to $27.9\mathrm{\%}$$27.9\mathrm{\%}$27.9%27.9 \% of samples $(34,43,44)$$(34,43,44)$(34,43,44)(34,43,44).
采血后立即倒置试管一次，并在抽血程序结束时至少倒置 5 至 10 次（具体次数由制造商确定）(40)。这种做法可防止标本因凝结而被拒收。特别是在凝血检测中，正确填充试管对确保血液/柠檬酸比率充足至关重要。如果样本充盈至理论充盈量的 $\le$$\le$<=\leq $90\mathrm{\%}$$90\mathrm{\%}$90%90 \% ，则活化部分凝血活酶时间（APTT）的结果可能已经出现偏差（56）。在 EFLM WG-PRE 观察性研究中， $24.2\mathrm{\%}$$24.2\mathrm{\%}$24.2%24.2 \% 的试管未充盈或过度充盈（42）。实验室报告的因样本量不足或样本-抗凝剂比例不足（即 0-34.9% 之间）而被拒收的样本范围很广，占所有错误中的 $13.1\mathrm{\%}$$13.1\mathrm{\%}$13.1%13.1 \% ( $7,34,43,44$$7,34,43,44$7,34,43,447,34,43,44 )。上述观察性研究显示， $30.4\mathrm{\%}$$30.4\mathrm{\%}$30.4%30.4 \% 样本管未正确混合（42）。据报道，因标本凝结而导致的拒收率高达 $27.9\mathrm{\%}$$27.9\mathrm{\%}$27.9%27.9 \% ，其中 $(34,43,44)$$(34,43,44)$(34,43,44)(34,43,44) 样本的拒收率高达 $27.9\mathrm{\%}$$27.9\mathrm{\%}$27.9%27.9 \% 。
To ensure the right sample collection it is necessary to standardize this procedure and organize
为确保正确的样本采集，有必要将这一程序标准化，并组织以下工作
trainings and audits for all involved members of the healthcare staff regularly $(22,45)$$(22,45)$(22,45)(22,45). Since the adherence to available recommendations seems to be low, the laboratory should provide local indications, for example based on guidelines of the EFLM WG-PRE and COLABIOCLI WG-PRE-LATAM, the CLSI or the World Health Organization (WHO), in the national language and establish a system to guarantee that all phlebotomists are trained correctly ( $40,42,52,57$$40,42,52,57$40,42,52,5740,42,52,57 ). For implementation and maintenance of such a system, the EFLM WG-PRE provides guidelines in several languages, as well as freely accessible tools, available at https://www. eflm.eu/site/page/a/1194. In addition, the laboratory should monitor the quality of blood collection by evaluation of appropriate Qls. These may reflect the number of samples with misidentification, incorrect sample type, incorrect filling volume, clotting or inappropriate time in sample collection, when appropriate (e.g. for circadian hormones and proteins) (18).
$(22,45)$$(22,45)$(22,45)(22,45) 定期对所有相关医护人员进行培训和审核。由于对现有建议的遵从度似乎很低，实验室应根据 EFLM WG-PRE 和 COLABIOCLI WG-PRE-LATAM、CLSI 或世界卫生组织（WHO）的指导方针，以本国语言提供当地的指示，并建立一个系统来保证所有抽血员都接受过正确的培训 ( $40,42,52,57$$40,42,52,57$40,42,52,5740,42,52,57 )。为实施和维护这一系统，EFLM WG-PRE 提供了多种语言的指南以及可免费获取的工具，网址为 https://www. eflm.eu/site/page/a/1194。此外，实验室应通过评估适当的 Qls 来监控采血质量。这些指标可反映出样本识别错误、样本类型不正确、灌装量不正确、凝血或样本 采集时间不当（如昼夜节律激素和蛋白质）的样本数量 (18)。

Identification errors may occur at several steps of the TTP, and are mentioned in the respective chapters (test ordering/test selection, sample collection, sample preparation and test reporting).
鉴定错误可能发生在 TTP 的几个步骤中，并在相应的章节（测试订购/测试选择、 样品采集、样品制备和测试报告）中提及。

The analytical stability of analytes is highly dependent on the time passed between blood collection and analysis, as well as on temperature and other ambient conditions (i.e. light exposure). Whereas some parameters may be stable for a long time, others may already be altered one hour after blood collection, or even earlier (58). To ensure the right sample transportation, local requirements have to be defined and distributed to all clinicians, nursing staff and carriers $(22,59)$$(22,59)$(22,59)(22,59). A survey among European laboratories on preanalytical practices for coagulation tests recently found that only $42\mathrm{\%}$$42\mathrm{\%}$42%42 \% of participating laboratories are actually monitoring temperature during transportation (60). Reported proportions of unsuitable samples due to inappropriate time and temperature condi-
分析物的分析稳定性在很大程度上取决于采血和分析之间的时间间隔，以及温度和其他环境条件（如光照）。有些参数可能在很长时间内保持稳定，而有些参数则可能在采血一小时后甚至更早（58）就发生了变化。为了确保正确的样本运输，必须确定当地的要求，并分发给所有临床医生、护理人员和运送人 $(22,59)$$(22,59)$(22,59)(22,59) 。最近在欧洲实验室中进行的一项关于凝血检测分析前操作的调查发现，只有 $42\mathrm{\%}$$42\mathrm{\%}$42%42 \% 参与调查的实验室在运输过程中实际监测温度（60）。据报告，由于时间和温度条件不合适而导致不合格样本的比例为 $42\mathrm{\%}$$42\mathrm{\%}$42%42 \% 。
tions can be as high as $3.4\mathrm{\%}$$3.4\mathrm{\%}$3.4%3.4 \% and $1.2\mathrm{\%}$$1.2\mathrm{\%}$1.2%1.2 \% of all samples received (Figure 5), respectively, and 1.9% in relation to the errors analysed (Figure 4) $(7,44)$$(7,44)$(7,44)(7,44). Unsuitable samples concerning transportation or storage should be monitored as Qls, and data loggers for time and temperature tracking may collect objective information for sample acceptance or rejection, as well as for recognizing and improving transportation errors $(18,61)$$(18,61)$(18,61)(18,61).
$3.4\mathrm{\%}$$3.4\mathrm{\%}$3.4%3.4 \% 和 $1.2\mathrm{\%}$$1.2\mathrm{\%}$1.2%1.2 \% ，分别占收到的所有样品的 $3.4\mathrm{\%}$$3.4\mathrm{\%}$3.4%3.4 \% 和 $1.2\mathrm{\%}$$1.2\mathrm{\%}$1.2%1.2 \% （图 5），以及与分析误差有关的 1.9% （图 4） $(7,44)$$(7,44)$(7,44)(7,44) 。不适合运输或储存的样品应作为 Qls 进行监控，用于时间和温度跟踪的数据记录器可收集客观信息，用于样品接收或剔除，以及识别和改进运输错误 $(18,61)$$(18,61)$(18,61)(18,61) 。
Beside deviations in time and temperature, samples can also get lost or damaged during transportation, and these events account for $0.2\mathrm{\%}$$0.2\mathrm{\%}$0.2%0.2 \% of samples or $3.1\mathrm{\%}$$3.1\mathrm{\%}$3.1%3.1 \% of all errors analysed $(7,18,44)$$(7,18,44)$(7,18,44)(7,18,44).
除了时间和温度上的偏差，样品在运输过程中也可能丢失或损坏，这些情况会导致 $0.2\mathrm{\%}$$0.2\mathrm{\%}$0.2%0.2 \% 个样品或 $3.1\mathrm{\%}$$3.1\mathrm{\%}$3.1%3.1 \% 个分析误差 $(7,18,44)$$(7,18,44)$(7,18,44)(7,18,44) 。
The use of pneumatic tubes systems (PTS) for sample transportation is commonplace in many hospitals (59). This type of sample delivery has been shown to induce cellular rupture of fragile blood cells, thereby potentially biasing test results $(62,63)$$(62,63)$(62,63)(62,63). However, because acceleration vector sums, peak g -forces, length and temperature depend on the construction and use of each specific PTS, studies show a high degree of heterogeneity (62). Therefore, each laboratory should validate
使用气管系统（PTS）运送样本在许多医院都很常见（59）。然而，由于加速度矢量和、峰值 g 力、长度和温度取决于每个特定 PTS 的构造和使用，研究显示存在很大程度的异质性（62）。因此，每个实验室都应验证
the local PTS by monitoring potentially affected parameters in relation to $g$$g$gg-forces recorded by 3 -axis accelerometers as Farnsworth et al. showed (63).
正如 Farnsworth 等人所展示的那样（63），通过监测与三轴加速度计记录的 $g$$g$gg 力相关的可能受影响的参数，对局部 PTS 进行监测。

After arrival in the laboratory, the sample has to be registered in the laboratory information system (LIS). Subsequently, most samples need to be centrifuged, decapped, aliquoted and sorted, depending on the requested analytes. Sample integrity has to be assessed whenever analytes are potentially biased by preanalytical variables such as underfilling, HIL, clots or air bubbles $(45,64)$$(45,64)$(45,64)(45,64). Centrifugation of serum samples need to be delayed until clot formation is completed, otherwise fibrin strands may clog the pipetting needle, so leading to inaccurate aspiration and even temporary malfunction of the analyzer (59).
样品到达实验室后，必须在实验室信息系统（LIS）中进行登记。随后，大多数样品都需要根据所需的分析物进行离心、去盖、等分和分类。只要分析前变量（如填充不足、HIL、血块或气泡）可能对分析物产生偏差，就必须对样品的完整性进行评估 $(45,64)$$(45,64)$(45,64)(45,64) 。血清样本的离心需要推迟到血凝块形成完成，否则纤维蛋白链可能会堵塞移液针，导致抽吸不准确，甚至使分析仪暂时失灵 (59)。

Error rates and Qls for unsuitable filling volume and clotted specimens have already been mentioned in the chapter “Sample collection”. Tran-
在 "样本采集 "一章中已经提到了不合适的填充量和凝血样本的误差率和 Qls。转

Figure 5. Published data on error rates (reference numbers are indicated in brackets) related to samples. IV - intravenous.
图 5.已公布的与样本有关的误差率数据（括号内为参考编号）。IV - 静脉注射。
scription errors may occur in facilities not using electronic order-entry systems (33). In general, every step of sample preparation which can be automated by pre-analytical workstations is effective to mitigate the risk of human errors $(33,45,64)$$(33,45,64)$(33,45,64)(33,45,64).
在未使用电子订单输入系统的机构中，可能会出现标注错误 (33)。一般来说，样品制备的每一个步骤，只要能通过分析前工作站实现自动化，就能有效降低人为错误的风险 $(33,45,64)$$(33,45,64)$(33,45,64)(33,45,64) 。

Haemolysis, icterus and lipemia may lead to erroneous test results of several analytes due to physical and chemical interferences (65-67). The assessment of so-called HIL-indices by spectrophotometric measurements should always be preferred over visual estimations ( $65,66,68$$65,66,68$65,66,6865,66,68 ). Parameter-specific HIL-cut-off values for sample rejection are mostly provided by manufacturers, but should then be verified by the laboratory before being implemented $(65,68,69)$$(65,68,69)$(65,68,69)(65,68,69).
由于物理和化学干扰，溶血、黄疸和脂血可能导致多种分析物的检测结果出错 (65-67)。通过分光光度法测量评估所谓的 HIL 指标应始终优于目测 ( $65,66,68$$65,66,68$65,66,6865,66,68 )。用于样品剔除的特定参数 HIL 截止值大多由制造商提供，但在实施前应由实验室进行验证 $(65,68,69)$$(65,68,69)$(65,68,69)(65,68,69) 。
The results of a survey among 1405 European laboratories show that $14\mathrm{\%}$$14\mathrm{\%}$14%14 \% of responders do not regularly monitor HIL and $30\mathrm{\%}$$30\mathrm{\%}$30%30 \% state to assess HIL interference only by visual inspection (Figure 2) (70). Haemolysis is reported in up to $2.2\mathrm{\%}$$2.2\mathrm{\%}$2.2%2.2 \% of all samples received in clinical laboratories (Figure 5) $(34,43,44)$$(34,43,44)$(34,43,44)(34,43,44). However, when blood collection is performed using intravenous (IV) catheters, haemolysis rates may grow substantially. Wollowitz et al. reported overall haemolysis rates for blood collection through butterfly needles and IV catheters of $2.7\mathrm{\%}$$2.7\mathrm{\%}$2.7%2.7 \% and $14.6\mathrm{\%}$$14.6\mathrm{\%}$14.6%14.6 \%, respectively (71). In the majority of cases haemolysis occurs in vitro and may therefore be prevented at several steps of the testing process from collection (e.g. using of appropriate needles or low vacuum tubes, avoiding excessive shaking) to transport (e.g. ensuring appropriate transport conditions), and sample preparation (e.g. appropriate force and time of centrifugation) ( $65,67,72$$65,67,72$65,67,7265,67,72 ). Monitoring of haemolysed samples by measurement of relative Qls is highly recommended (18).
对欧洲 1405 家实验室进行的一项调查结果显示， $14\mathrm{\%}$$14\mathrm{\%}$14%14 \% 家实验室没有定期监测 HIL， $30\mathrm{\%}$$30\mathrm{\%}$30%30 \% 家实验室仅通过目测评估 HIL 干扰（图 2）（70）。据报道，在临床实验室收到的所有样本中，溶血率高达 $2.2\mathrm{\%}$$2.2\mathrm{\%}$2.2%2.2 \% （图 5） $(34,43,44)$$(34,43,44)$(34,43,44)(34,43,44) 。 不过，当使用静脉（IV）导管采血时，溶血率可能会大幅上升。Wollowitz 等人报告称，通过蝶形针和静脉导管采血的总体溶血率分别为 $2.7\mathrm{\%}$$2.7\mathrm{\%}$2.7%2.7 \% 和 $14.6\mathrm{\%}$$14.6\mathrm{\%}$14.6%14.6 \% （71）。大多数情况下，溶血发生在体外，因此可在检测过程的多个步骤中加以预防，从采集（如使用适当的针头或低真空管，避免过度摇晃）到运输（如确保适当的运输条件）和样本制备（如适当的离心力和离心时间） ( $65,67,72$$65,67,72$65,67,7265,67,72 )。强烈建议通过测量相对 Qls 来监测溶血样本（18）。
Unlike haemolysis, lipemia and icterus may be considered in vivo interferences. Lipemia account for approximately $0.1-2.5\mathrm{\%}$$0.1-2.5\mathrm{\%}$0.1-2.5%0.1-2.5 \% of all samples rejected $(44,66)$$(44,66)$(44,66)(44,66). To prevent lipemia, blood sampling should not be performed after eating a meal or intravenous administration of lipid emulsions. When the presence of lipemia cannot be eliminated, addi-
与溶血不同，脂血和黄疸可视为体内干扰。在所有被剔除的样本中，脂血约占 $0.1-2.5\mathrm{\%}$$0.1-2.5\mathrm{\%}$0.1-2.5%0.1-2.5 \% $(44,66)$$(44,66)$(44,66)(44,66) 。为防止脂肪血症，进餐或静脉注射脂质乳剂后不应进行血液采样。当无法排除脂血症的存在时，应增加
tional centrifugation steps, sample dilution or specific clearing reagents might be helpful (66).
离心步骤、样本稀释或特异性清除试剂可能会有所帮助（66）。

Since recommendations on centrifugation conditions from manufacturers of blood collection systems as well as other sources differ in time and speed, ranging from $\le 1300\mathrm{xg}$$\le 1300\mathrm{xg}$<= 1300xg\leq 1300 \mathrm{xg} to 4000 xg , and from 3 to 15 minutes ), this preanalytical step may display large heterogeneity ( $58,73-75$$58,73-75$58,73-7558,73-75 ). A survey carried out by the External Quality Assurance Providers in Laboratory Medicine (EQALM) recently confirmed that this practice is considerably variable across many European laboratories (60). Since blood tubes manufacturers cannot validate all available parameters on all analytical platforms, recommendations are mostly set to a longer centrifugation time at a lower speed to assure sample quality. However, several studies showed that shorter centrifugation time at a higher speed may not significantly alter specific tests results, while being effective to lower the turnaround time $(76,77)$$(76,77)$(76,77)(76,77).
由于采血系统制造商和其他来源推荐的离心条件在时间和速度上各不相同，从 $\le 1300\mathrm{xg}$$\le 1300\mathrm{xg}$<= 1300xg\leq 1300 \mathrm{xg} 到 4000 xg 不等，时间从 3 分钟到 15 分钟不等（ $58,73-75$$58,73-75$58,73-7558,73-75 ），因此这一分析前步骤可能存在很大的差异（ $58,73-75$$58,73-75$58,73-7558,73-75 ）。实验室医学外部质量保证提供者（EQALM）最近进行的一项调查证实，许多欧洲实验室的这一做法存在很大差异（60）。由于血管制造商无法在所有分析平台上验证所有可用参数，因此建议大多采用较低转速延长离心时间，以确保样本质量。然而，一些研究表明，以较高的速度缩短离心时间可能不会明显改变特定的检测结果，但却能有效缩短周转时间 $(76,77)$$(76,77)$(76,77)(76,77) 。

To assure that analyses are carried out within the predefined time of stability of the various laboratory parameters, all necessary timestamps, such as specimen collection time, time of centrifugation and analysis must be available in the LIS (59). As already mentioned above (see sections Time of blood collection, Transport), automated systems for linking barcodes of patients and tubes or data loggers could aid in documenting timestamps $(33,45,61)$$(33,45,61)$(33,45,61)(33,45,61).
为确保在预定的各种实验室参数稳定时间内进行分析，所有必要的时间戳，如标本 采集时间、离心时间和分析时间，都必须在 LIS 系统中提供（59）。如上文所述（见采血时间、转运），连接患者和试管条形码的自动化系统或数据记录仪可帮助记录时间戳 $(33,45,61)$$(33,45,61)$(33,45,61)(33,45,61) 。

The internal quality control (IQC), as well as EQA schemes, are cornerstones of quality assessment in the analytical phase $(78,79)$$(78,79)$(78,79)(78,79). Laboratories must ensure that results cannot be released when internal quality control is out of range, as this mistake is reported by Carraro et al. (Figure 4) (7). Quality in-
$(78,79)$$(78,79)$(78,79)(78,79) 内部质量控制 (IQC) 和 EQA 计划是分析阶段质量评估的基石。实验室必须确保在内部质量控制超出范围时不能发布结果，Carraro 等人报告了这一错误（图 4）(7)。质量控制

Figure 6. Error rates related to phlebotomies in an observational study (42).
图 6.一项观察性研究中与抽血相关的错误率（42）。
dicators encompass unacceptable quality control (QC) results as well as the number of tests uncovered by QC (18).
指标包括不可接受的质控（QC）结果以及质控发现的检测数量（18）。
Despite a high degree of standardization and implementation of quality management systems, errors in the analytical phase can still be operatordependent, a consequence of deviations from recommendation/guidelines or attributable to instrumental malfunctioning (Figure 4) $(6,80)$$(6,80)$(6,80)(6,80).
尽管高度标准化并实施了质量管理体系，但分析阶段的错误仍可能与操作有关，是偏离建议/指南的结果，或可归因于仪器故障（图 4） $(6,80)$$(6,80)$(6,80)(6,80) 。

Analytical interferences are still a huge challenge. As previously mentioned, well-known and “prior-to-analysis” measureable interferences (e.g., HIL), which are also referred to as type 1 interferences, should be checked by automated HIL assessment ( $65,66,68,81,82$$65,66,68,81,82$65,66,68,81,8265,66,68,81,82 ).
分析干扰仍然是一个巨大的挑战。如前所述，众所周知的和 "分析前 "可测量的干扰（如 HIL），也称为 1 型干扰，应通过自动 HIL 评估 ( $65,66,68,81,82$$65,66,68,81,82$65,66,68,81,8265,66,68,81,82 ) 进行检查。
The so-called type 2 interferences can be due to heterophilic antibodies, anti-animal antibodies, anti-reagent antibodies, rheumatoid factor, biotin, macrocomplexes or paraproteins (81-83). Immunoassay results can be altered by such interferences in up to 4% (Figure 1) (84). Even if Emerson et al. cite in their review that the incidence of interference is estimated to be $<2\mathrm{\%}$$<2\mathrm{\%}$< 2%<2 \%, the risk of errors is unquestionably higher considering the large number of immunoassays routinely performed in clinical laboratories (81). Because these interferences are reproducible, occur unexpectedly, and cannot
所谓的第二类干扰可由嗜异性抗体、抗动物抗体、抗试剂抗体、类风湿因子、生物素、大复合物或副蛋白引起（81-83）。免疫测定结果受此类干扰的影响可达 4%（图 1）（84）。即使 Emerson 等人在其综述中指出干扰发生率估计为 $<2\mathrm{\%}$$<2\mathrm{\%}$< 2%<2 \% ，但考虑到临床实验室常规进行的免疫测定数量庞大，出错的风险无疑更高（81）。因为这些干扰具有可重复性，会意外发生，并且不能
be detected by conventional quality control procedures, the possibility of false-positive or falsenegative results must always be taken into account, especially if plausibility or delta-checks are suspicious. Nevertheless, interferences may even be clinically plausible, thus making their identification really challenging (84). Upon suspicion, algorithms may help to detect analytical interferences by several measures (Appendix 1) (82,83). Information about analytical interferences should be included in the patient’s medical report since interfering antibodies may persist for a long time.
在常规质控程序检测到干扰物时，必须始终考虑到假阳性或假阴性结果的可能 性，尤其是在可信度或 delta 检查可疑的情况下。然而，干扰甚至可能在临床上是可信的，因此对其进行识别确实具有挑战性（84）。如果怀疑存在干扰，算法可通过几种方法（附录 1）帮助检测分析干扰（82,83）。由于干扰抗体可能会长期存在，因此患者的医疗报告中应包含有关分析干扰的信息。
Notably, some conditions of the specimen itself may also lead to invalid test results. Extreme leucocytosis can lead to pseudohyperkalaemia or pseudohypoglycemia $(5,85)$$(5,85)$(5,85)(5,85). Hyperlipidemia or hyperproteinaemia result in spurious pseudohyponatremia when indirect ion-selective electrodes are used for measurement $(85,86)$$(85,86)$(85,86)(85,86). In cases of implausible results, re-testing needs to be conducted.
值得注意的是，标本本身的某些情况也可能导致检测结果无效。当使用间接离子选择电极进行测量时，高脂血症或高蛋白血症会导致假性高钠血症 $(85,86)$$(85,86)$(85,86)(85,86) 。如果出现难以置信的结果，则需要重新进行测试。

After analysis, results have to be entered into the LIS. Plebani et al. reported that $2.6\mathrm{\%}$$2.6\mathrm{\%}$2.6%2.6 \% of mistakes were related to transcription errors (6). Since manual procedures seem to be especially vulnerable to clerical errors, automation of result transfer from analyzer to LIS should be preferred, and manual transcription errors monitored $(18,33,80)$$(18,33,80)$(18,33,80)(18,33,80).
分析结束后，必须将结果输入 LIS。Plebani 等人报告说， $2.6\mathrm{\%}$$2.6\mathrm{\%}$2.6%2.6 \% 的错误与转录错误有关（6）。由于人工操作似乎特别容易出现笔误，因此应优先考虑将结果从分析仪自动传输到 LIS，并对人工转录错误进行监控 $(18,33,80)$$(18,33,80)$(18,33,80)(18,33,80) 。

The process of deciding whether or not a result can be released comprises the comparison with reference intervals, critical values or clinical decision limits, as well as the assessment of deltachecks, taking clinical diagnosis and therapeutic procedures into account in order to enhance the possibility of detecting preanalytical or analytical errors that have been undetected so far $(33,87)$$(33,87)$(33,87)(33,87). In general, doubtful results should be replaced by a comment providing appropriate information and recommendation for further sample management (i.e. recollection) (87). However, considering the potential clinical importance of knowingly biased results (i.e. due to haemolysis), Lippi et al. proposed an alternative approach. These values may be released accompanied by a comment, when the deviation of the test results is unlikely to exceed clinical significance, which may be assessed with calculation of the reference change value (RCV) (68).
决定一项结果是否可以公布的过程包括与参考区间、临界值或临床决定限值的比较，以及对脱钩的评估，同时考虑到临床诊断和治疗程序，以提高发现分析前或分析过程中至今未被发现的错误的可能性 $(33,87)$$(33,87)$(33,87)(33,87) 。一般来说，有疑问的结果应以注释代替，提供适当的信息并建议进一步的样本管理（即回收）（87）。不过，考虑到明知结果有偏差（如溶血所致）的潜在临床重要性，Lippi 等人提出了另一种方法。当检测结果的偏差不太可能超过临床意义时，这些数值可与注释一起发布，临床意义可通过计算参考变化值（RCV）来评估（68）。
Up to $85\mathrm{\%}$$85\mathrm{\%}$85%85 \% of reported identification errors may be noticed before results are made available to clinicians or patients, once again highlighting the importance of correct patient result validation $(22,88)$$(22,88)$(22,88)(22,88). Automated validation systems, which have proven to be efficient, may partly replace manual validation, a time-consuming and almost subjective task $(89,90)$$(89,90)$(89,90)(89,90). However, these systems must be validated to prevent the release of erroneous test results (87).
多达 $85\mathrm{\%}$$85\mathrm{\%}$85%85 \% 的报告鉴定错误可能会在结果提供给临床医生或患者之前就被发现，这再次凸显了正确验证患者结果的重要性 $(22,88)$$(22,88)$(22,88)(22,88) 。自动验证系统已被证明是高效的，可以部分取代人工验证这一耗时且近乎主观的任务 $(89,90)$$(89,90)$(89,90)(89,90) 。 然而，这些系统必须经过验证，以防止发布错误的检测结果（87）。

On the laboratory report, results must be provided with the correct measuring unit, preferentially SI units $(22,87)$$(22,87)$(22,87)(22,87). In addition, the appropriate reference intervals (RI) or decision limits (DL), taking into account age and gender of the population must be provided for appropriate data interpretation ( 87,91 ). However, it must be kept in mind, that RIs only cover the central $95\mathrm{\%}$$95\mathrm{\%}$95%95 \% of the studied population.
在实验室报告中，结果必须使用正确的测量单位，最好是国际单位 $(22,87)$$(22,87)$(22,87)(22,87) 。此外，还必须根据人群的年龄和性别提供适当的参考区间（RI）或判定限（DL），以便对数据进行适当的解释（87,91）。不过，必须牢记的是，参考区间只涵盖研究人群的 $95\mathrm{\%}$$95\mathrm{\%}$95%95 \% 中心区域。

Since Rls determination for the local population and the specific analytical methods carried out in 120 healthy subjects for each age-range, race and gender, is time-consuming and financially unsustainable by many laboratories, verification of already published reference intervals seems to be a feasible solution (92). For further information we refer to CLSI document C28-A3c or the recommendation of the Working Group Accreditation and ISO/CEN standards (WG-A/ISO) of the EFLM $(92,93)$$(92,93)$(92,93)(92,93).
由于在 120 名健康受试者中对每个年龄段、种族和性别的当地人口和特定分析方法进行 Rls 测定既耗时又耗资，许多实验室难以承受，因此验证已公布的参考区间似乎是一个可行的解决方案 (92)。欲了解更多信息，请参阅 CLSI 文件 C28-A3c 或 EFLM 的认证和 ISO/CEN 标准工作组 (WG-A/ISO) 的建议 $(92,93)$$(92,93)$(92,93)(92,93) 。
Alternatively, DLs, which are established by consensus for lipids and glycated haemoglobin (HbA1c), may be provided for interpretation. Laboratories may verify the correct use of RIs and DLs by the relative quality specifications, as proposed by Ceriotti et al. (91). However, the concept of such RI does not take preceding values into account. The RCV has hence been proposed for better reflecting the (clinically) significant change of serial results (94).
或者，也可提供经一致同意为血脂和糖化血红蛋白（HbA1c）确定的 DL 进行解释。实验室可根据 Ceriotti 等人提出的相对质量规格（91）来验证 RI 和 DL 的正确使用。然而，这种 RI 的概念并没有将前值考虑在内。因此，有人提出了 RCV，以更好地反映序列结果的（临床）显著变化（94）。

According to ISO 15189 requirements and other recommendations, critical values must be clearly defined, along with a detailed process on how stakeholders will be informed in a timely manner $(13,87)$$(13,87)$(13,87)(13,87). Although there are differences in the way clinical laboratories report critical values, a survey among Croatian medical biochemistry laboratories showed that $99.1\mathrm{\%}$$99.1\mathrm{\%}$99.1%99.1 \% of responders follow these requirements (95). Thresholds beyond which test results are considered critical need to be defined based on well-designed outcome studies and in collaboration with clinicians. However, such thresholds are often outdated or based on expert opinion, as reliable studies are often missing (96). The time from result validation to result communication should be documented and benchmarked as Ql for purposes of future improvement $(18,87)$$(18,87)$(18,87)(18,87).
根据 ISO 15189 的要求和其他建议，必须明确定义临界值，并详细说明如何及时通知利益相关者 $(13,87)$$(13,87)$(13,87)(13,87) 。尽管临床实验室报告临界值的方式存在差异，但一项对克罗地亚医学生化实验室的调查显示， $99.1\mathrm{\%}$$99.1\mathrm{\%}$99.1%99.1 \% 的受访者遵循了这些要求（95）。需要根据精心设计的结果研究，并与临床医生合作，确定将检测结果视为临界值的阈值。然而，这些阈值往往已经过时，或基于专家意见，因为往往缺乏可靠的研究（96）。从结果验证到结果通报的时间应记录在案，并以 Ql 为基准，以便今后改进 $(18,87)$$(18,87)$(18,87)(18,87) 。

To avoid delays in diagnosis and treatment, patient samples should be processed as quickly as possible (22). However, different approaches to measurement and definition of turnaround time (TAT) makes data comparison often challenging (97). The total TAT or “therapeutic TAT”, describes
为避免延误诊断和治疗，应尽快处理患者样本（22）。然而，由于测量和定义周转时间（TAT）的方法不同，数据比较往往具有挑战性（97）。总周转时间或 "治疗周转时间 "描述的是
the time interval between test ordering to the time when a treatment decision is made. As timestamps necessary to calculate these intervals are often missing (see chapters Sample collection and Transport), laboratories often refer to the intra-laboratory TAT, intended as the time from sample reception in the laboratory to release of test results. These time intervals should be collected on a regular basis for surrogate parameters and benchmarked with other laboratories (18). If the results do not meet the target values, total laboratory automation may help improving TAT (64). In addition, intra-laboratory sample processing should be continuously monitored with color-coded alarms when individual samples are processed too slow.
是指从下单检测到做出治疗决定之间的时间间隔。由于计算这些时间间隔所需的时间戳经常缺失（参见样本采集与运输章节），实验室通常使用实验室内 TAT，即从实验室接收样本到发布检测结果的时间。应定期收集代用参数的这些时间间隔，并与其他实验室进行比较 (18)。如果结果达不到目标值，实验室全面自动化可能有助于改善 TAT（64）。此外，应持续监控实验室内的样本处理过程，当个别样本处理速度过慢时，应使用彩色编码报警。
Although the measurement of intra-laboratory TAT is easier, laboratories should aim to collect data on therapeutic TAT, since up to $96\mathrm{\%}$$96\mathrm{\%}$96%96 \% of delays are non-analytical (97). Again, collaboration with clinicians is necessary to understand their expectations and to assess where improvements outside the laboratory are most feasible.
虽然实验室内 TAT 的测量比较容易，但实验室应致力于收集治疗 TAT 的数据，因为多达 $96\mathrm{\%}$$96\mathrm{\%}$96%96 \% 的延误是非分析性的（97）。同样，有必要与临床医生合作，以了解他们的期望，并评估在实验室以外的哪些方面进行改进是最可行的。

Despite thoughtful validation, errors may be detected after the report has already been made available to clinicians or patients. In a retrospective analysis, only $0.01\mathrm{\%}$$0.01\mathrm{\%}$0.01%0.01 \% of the reported results had to be corrected (Figure 1) (80). Nevertheless, each revised result involves the risk of being overlooked by the physician (Figure 1 and 4) $(6,80)$$(6,80)$(6,80)(6,80). Therefore, the responsible persons must be informed whenever laboratory reports were changed $(80,87)$$(80,87)$(80,87)(80,87). The abovementioned study revealed that this procedure has only been documented in $58\mathrm{\%}$$58\mathrm{\%}$58%58 \% of cases. The number as well as the reasons of revised reports should be assessed to identify and improve error-prone steps throughout the TTP $(18,80,87)$$(18,80,87)$(18,80,87)(18,80,87).
尽管进行了周到的验证，但在报告提供给临床医生或患者后，错误仍有可能被发现。在一项回顾性分析中，只有 $0.01\mathrm{\%}$$0.01\mathrm{\%}$0.01%0.01 \% 项报告结果需要更正（图 1）（80）。尽管如此，每次修改结果都有可能被医生忽视（图 1 和 4） $(6,80)$$(6,80)$(6,80)(6,80) 。因此，每当实验室报告发生变化时，必须通知相关负责人 $(80,87)$$(80,87)$(80,87)(80,87) 。上述研究显示，只有 $58\mathrm{\%}$$58\mathrm{\%}$58%58 \% 个病例记录了这一程序。应该对修改报告的数量和原因进行评估，以确定和改进整个技术处理计划中容易出错的步骤 $(18,80,87)$$(18,80,87)$(18,80,87)(18,80,87) 。

Physicians may receive up to 1000 laboratory test results each week (98). Ideally, a visualization tech-
医生每周可能会收到多达 1000 份化验结果（98）。理想情况下，可视化技术
nique that meets the local requirements is selected in collaboration with clinicians, for ensuring appropriate assessment of crucial results. A survey focusing on potentially actionable results, which were not available at the patient’s discharge, revealed that the rate of unawareness was as high as $61.6\mathrm{\%}$$61.6\mathrm{\%}$61.6%61.6 \% (Figure 2). Thereof $37.1\mathrm{\%}$$37.1\mathrm{\%}$37.1%37.1 \% of cases would have required diagnostic or therapeutic alterations, whilst urgent action would have been necessary in $12.6\mathrm{\%}$$12.6\mathrm{\%}$12.6%12.6 \% of cases (99).
为确保对关键结果进行适当评估，我们与临床医生合作选择了符合当地要求的技术。一项重点针对患者出院时无法获得的潜在可操作结果的调查显示，不知晓率高达 $61.6\mathrm{\%}$$61.6\mathrm{\%}$61.6%61.6 \% （图 2）。因此， $37.1\mathrm{\%}$$37.1\mathrm{\%}$37.1%37.1 \% 的病例需要改变诊断或治疗方法，而 $12.6\mathrm{\%}$$12.6\mathrm{\%}$12.6%12.6 \% 的病例则需要采取紧急措施（99）。
Patients should also be informed on test results, diagnoses as well as changes in therapy. An evaluation in an outpatient clinic, carried out by Schiff et al., revealed that $2\mathrm{\%}$$2\mathrm{\%}$2%2 \% of potassium prescriptions were related to patients whose current or previous potassium result was $\ge 5.3\mathrm{mmol}/\mathrm{L}$$\ge 5.3\mathrm{mmol}/\mathrm{L}$>= 5.3mmol//L\geq 5.3 \mathrm{mmol} / \mathrm{L}, and that no evidence of contacting the patient could be found (100). In another study Schiff et al. found that at least $2\mathrm{\%}$$2\mathrm{\%}$2%2 \% of patients with thyroid-stimulating hormone concentration of $\ge 20\mathrm{mlU}/\mathrm{mL}$$\ge 20\mathrm{mlU}/\mathrm{mL}$>= 20mlU//mL\geq 20 \mathrm{mlU} / \mathrm{mL} were not informed about their pathologic result or a potential diagnosis of hypothyroidism (101). The failure rates to inform patients about abnormal results or to document this action are found to be as high as $26.2\mathrm{\%}$$26.2\mathrm{\%}$26.2%26.2 \% (Figure 1) (102). Reporting results in addition directly to the patient may be one possibility to reduce missed diagnoses. However, the advantages and disadvantages have to be considered before implementation (103).
此外，还应向患者告知检测结果、诊断以及治疗方法的改变。Schiff 等人对一家门诊诊所进行的一项评估显示， $2\mathrm{\%}$$2\mathrm{\%}$2%2 \% 的钾处方与当前或之前钾结果为 $\ge 5.3\mathrm{mmol}/\mathrm{L}$$\ge 5.3\mathrm{mmol}/\mathrm{L}$>= 5.3mmol//L\geq 5.3 \mathrm{mmol} / \mathrm{L} 的患者有关，而且找不到与患者联系的证据（100）。Schiff 等人在另一项研究中发现，至少 $2\mathrm{\%}$$2\mathrm{\%}$2%2 \% 名促甲状腺激素浓度为 $\ge 20\mathrm{mlU}/\mathrm{mL}$$\ge 20\mathrm{mlU}/\mathrm{mL}$>= 20mlU//mL\geq 20 \mathrm{mlU} / \mathrm{mL} 的患者未被告知其病理结果或甲状腺功能减退的潜在诊断（101）。未将异常结果告知患者或记录这一行动的比例高达 $26.2\mathrm{\%}$$26.2\mathrm{\%}$26.2%26.2 \% （图 1）(102)。直接向患者报告结果可能是减少漏诊的一种方法。然而，在实施前必须考虑其利弊（103）。

Providing laboratory test results in the fastest time and with the highest possible quality may both be useless when data are incorrectly interpreted. Interpretation of laboratory test results has to be performed considering clinical history, symptoms, physical examination and results of other diagnostic disciplines, so deciding whether or not the test result is valid and eligible for patient care (104).
如果对数据的解释不正确，那么在最快的时间内提供最高质量的化验结果可能都是无用的。实验室检验结果的解读必须考虑临床病史、症状、体格检查和其他诊断学科的结果，从而决定检验结果是否有效，是否符合病人护理的要求（104）。
According to a survey carried out by Hickner et al., nearly $8\mathrm{\%}$$8\mathrm{\%}$8%8 \% of primary care physicians may have uncertainties in interpreting laboratory test results, but even laboratory staff may be challenged in specific situations $(11,105)$$(11,105)$(11,105)(11,105). Gandhi et al., along with Kachalia et al., evaluated closed malpractice claims and reported that incorrect interpretations may
根据 Hickner 等人进行的一项调查，近 $8\mathrm{\%}$$8\mathrm{\%}$8%8 \% 名初级保健医生在解释实验室检测结果时可能存在不确定性，但即使是实验室工作人员在特定情况下也可能面临挑战 $(11,105)$$(11,105)$(11,105)(11,105) 。Gandhi 等人与 Kachalia 等人一起对已结案的医疗事故索赔进行了评估，并报告说，不正确的解释可能会造成以下后果
account for up to $37\mathrm{\%}$$37\mathrm{\%}$37%37 \% of missed or delayed diagnoses (Figure 3) $(25,26)$$(25,26)$(25,26)(25,26). At least $50\mathrm{\%}$$50\mathrm{\%}$50%50 \% of reported erroneous results due to analytical interference, which were not recognized in the process of validation, led to misdiagnosis and inappropriate management by the clinician (83).
$37\mathrm{\%}$$37\mathrm{\%}$37%37 \% 的漏诊或延误诊断（图 3） $(25,26)$$(25,26)$(25,26)(25,26) 。至少 $50\mathrm{\%}$$50\mathrm{\%}$50%50 \% 个报告的错误结果是由于分析干扰造成的，这些干扰在验证过程中没有被识别出来，导致了临床医生的误诊和不恰当处理（83）。
Furthermore, different analytical methods or instruments often provide non-comparable results of the same analyte (e.g. hormone tests) (106). In addition, clinical conditions may bias test results, e.g., HbA1c test results may be falsely low when underlying diseases are associated with a reduced erythrocyte lifespan (85). Other biasing conditions include unchangeable interferences of the specimen itself, such as leucocytosis or hyperproteinaemia (see chapter Analysis), or deviations from recommendations on blood collection (see chapter Sample collection). All these circumstances need to be acknowledged and taken into account when interpreting test results.
此外，不同的分析方法或仪器对同一分析物（如激素检测）的检测结果往往不具有可比性（106）。此外，临床条件也会使检测结果产生偏差，例如，当潜在疾病与红细胞寿命缩短有关时，HbA1c 检测结果可能会偏低（85）。其他偏差条件包括标本本身不可改变的干扰，如白细胞增多或高蛋白血症（见分析一章），或偏离采血建议（见样本采集一章）。在解释检测结果时，必须承认并考虑到所有这些情况。
Since laboratory specialists are trained in the task of test selection and interpretation, they should aid clinicians in diagnosing patients correctly (107). Especially when results are not consistent with the clinical picture, physicians should be encouraged to get in touch with the laboratory. However, Hickner et al. found that although laboratory consultations are rated as helpful by $35\mathrm{\%}$$35\mathrm{\%}$35%35 \% of surveyed primary care physicians, only 6% approach laboratory professionals in case of uncertainty during test interpretation (11).
由于化验室专家接受过化验选择和解释方面的培训，他们应协助临床医生正确诊断病人（107）。尤其是当结果与临床表现不一致时，应鼓励医生与实验室取得联系。然而，Hickner 等人发现，虽然 $35\mathrm{\%}$$35\mathrm{\%}$35%35 \% 接受调查的初级保健医生认为实验室咨询很有帮助，但只有 6% 的医生在检验解释过程中遇到不确定因素时会联系实验室专业人员（11）。
Reflective testing as well as narrative interpretation of results may aid to reduce medical error (31).
反思性测试以及对结果的叙述性解释有助于减少医疗失误（31）。

The latter might even have an educational impact on test selection and ordering behaviour or a positive effect on the health care budget $(28,108)$$(28,108)$(28,108)(28,108). As a premise, clinical information and indications must be provided along with the test request. In addition, diagnostic management teams have proven the same efficiency $(32,82)$$(32,82)$(32,82)(32,82). The number of reports with interpretative comments can be assessed as QI (18).
后者甚至可能对检验项目的选择和订购行为产生教育影响，或对医疗预算产生积极影响 $(28,108)$$(28,108)$(28,108)(28,108) 。作为前提，临床信息和适应症必须与检验申请一起提供。此外，诊断管理小组也证明了同样的效率 $(32,82)$$(32,82)$(32,82)(32,82) 。附有解释性意见的报告数量可作为 QI 进行评估（18）。

Since laboratory results are essential in most medical decisions, high quality laboratory testing with an appropriate TAT is crucial. Although several guidelines and recommendations (summarized in Appendix 1) are available for every step in the TTP, an observational study has shown low compliance rates thereof (42). Moreover, published data on error rates are still high for the extra-laboratory phases as we could demonstrate in this review.
由于化验结果对大多数医疗决策至关重要，因此高质量的化验和适当的 TAT 至关重要。尽管针对 TTP 的每一个步骤都有一些指南和建议（摘要见附录 1），但一项观察性研究显示，这些指南和建议的遵守率很低（42）。此外，正如我们在本综述中所展示的，已公布的实验室外阶段的错误率数据仍然很高。
In our opinion, the core duty of medical laboratories is not only to provide high quality analytics but also to aid in finding the right diagnosis of patients. Therefore, laboratory specialists should make an effort to surveil the whole TTP using the Qls concept (18) and refocus on improving errorprone extra-laboratory processes, especially test selection and interpretation, in collaboration with physicians of other medical departments (107).
我们认为，医学实验室的核心职责不仅是提供高质量的分析结果，而且还要帮助患者找到正确的诊断方法。因此，实验室专家应与其他医疗部门的医生合作（107），利用 Qls 概念（18）努力调查整个 TTP，并将重点重新放在改善容易出错的实验室外流程上，尤其是检验项目的选择和解释。

None declared.  无声明。

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