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1.
A universal coagulation test that reliably detects prolonged coagulation time in patients, irrespective of the anticoagulant administered, has not been available to date. An easily miniaturised, novel μ-fluidic universal coagulation test employing surface acoustic waves (SAW) is presented here. SAW was employed to instantly mix and recalcify 6 μl citrated whole blood and image correlation analysis was used to quantify clot formation kinetics. The detection of clinically relevant anticoagulant dosing with old anticoagulants (unfractionated heparin, argatroban) and new anticoagulants (dabigatran, rivaroxaban) has been tested and compared to standard plasma coagulation assays. The applicability of this novel method has been confirmed in a small patient population. Coagulation was dose-proportionally prolonged with heparin, argatroban, dabigatran, and rivaroxaban, comparable to standard tests. Aspirin and clopidogrel did not interfere with the SAW-induced clotting time (SAW-CT), whereas the strong GPIIb/IIIa-inhibitor abciximab did interfere. Preliminary clinical data prove the suitability of the SAW-CT in patients being treated with warfarin, rivaroxaban, or dabigatran. The system principally allows assessment of whole blood coagulation in humans in a point-of-care setting. This method could be used in stroke units, emergency vehicles, general and intensive care wards, as well as for laboratory and home testing of coagulation.  相似文献   

2.
External Quality Assessment Scheme (EQAS) involves evaluation of a number of laboratories by an outside agency on the performance of a number of laboratories based on their analytical performance of tests on samples supplied by the external agency. In developing countries, establishment of national EQAS by preparing homemade quality control material is a useful scheme in terms of resources and time to monitor the laboratory performance. The objective of this study is to implement an EQAS to monitor the analytical performance of the district laboratories in Bhutan. Baseline information was collected through questionnaires. Lyophilized human serum including normal and abnormal levels were prepared and distributed to 19 participating laboratories. Nine routine analytes were included for the study. Their results were evaluated using Variance index scores (VIS) and Coefficient of variations (CV) was compared with Clinical Laboratory Improvement Act (CLIA) Proficiency Testing Criteria (PT) for each analyte. There was significant decrease in CV at the end of the study. The percentages of results in acceptable VIS as ‘A’ were 63, 60, 66, 69, 73 and 74, 75, 76 and 79 % in November 2009–July 2010 respectively. From our results, we concluded that, establishment of EQAS through distribution of home-made quality control material could be the useful scheme to monitor the laboratory performance in clinical chemistry in Bhutan.  相似文献   

3.

Introduction:

Capillary sampling is increasingly used to obtain blood for laboratory tests in volumes as small as necessary and as non-invasively as possible. Whether capillary blood sampling is also frequent in Croatia, and whether it is performed according to international laboratory standards is unclear.

Materials and methods:

All medical laboratories that participate in the Croatian National External Quality Assessment Program (N = 204) were surveyed on-line to collect information about the laboratory’s parent institution, patient population, types and frequencies of laboratory tests based on capillary blood samples, choice of reference intervals, and policies and procedures specifically related to capillary sampling. Sampling practices were compared with guidelines from the Clinical and Laboratory Standards Institute (CLSI) and the World Health Organization (WHO).

Results:

Of the 204 laboratories surveyed, 174 (85%) responded with complete questionnaires. Among the 174 respondents, 155 (89%) reported that they routinely perform capillary sampling, which is carried out by laboratory staff in 118 laboratories (76%). Nearly half of respondent laboratories (48%) do not have a written protocol including order of draw for multiple sampling. A single puncture site is used to provide capillary blood for up to two samples at 43% of laboratories that occasionally or regularly perform such sampling. Most respondents (88%) never perform arterialisation prior to capillary blood sampling.

Conclusions:

Capillary blood sampling is highly prevalent in Croatia across different types of clinical facilities and patient populations. Capillary sampling procedures are not standardised in the country, and the rate of laboratory compliance with CLSI and WHO guidelines is low.  相似文献   

4.
Pathology laboratories group some tests that they perform on their high throughput biochemistry analysers into profiles of tests that are associated with different organs (e.g. liver function tests—LFT). The components of these profiles are historic and often vary between different laboratories. This can lead to confusion and begs the question of what should be in a particular profile. In community medicine profiles may be used as screening tests but some of the components of the profiles may have low sensitivity and specificity and may produce both false positives and negatives. The LFT may include components which are poor liver function tests but are sensitive to fatty liver and hence elevations may cause unnecessary concern. Harmonisation of clinical chemistry reference intervals and units is occurring now so it is time to consider a similar process for components of a profile. A proposed list of analytes to be performed in the LFT profile is given.  相似文献   

5.
美国国防部是美国国家实验室的重要资助单位,在最高峰时期,美国国防部曾经资助过34家国家实验室。目前仍然资助10家国家实验室。文章详细分析了美国国防部下属国家实验室构建的"资助机构—运营机构—国家实验室"三层管理体制。根据联邦采购法案(FAR),资助机构决定国家实验室的研究方向和领域,国家实验室要依照资助机构的特殊要求或章程来执行研发任务。运营机构负责国家实验室的日常管理,包括实验室主任等高级管理人员的选聘等。资助机构通过驻地办公室对国家实验室运行中存在的风险和绩效进行评估,并根据评估的结果来确定国家实验室的绩效收入和补贴。美国国家实验室的三层级管理模式一方面可以使国家实验室获得稳定的联邦政府资助,另一方面又能在具体的事务管理上保持相对的灵活性,这种模式较为符合科研规律,对于中国构建国家实验室体系也具有一定的参考意义。  相似文献   

6.
Quality can be defined as the ability of a product or service to satisfy the needs and expectations of the customer. Laboratories are more focusing on technical and analytical quality for reliability and accuracy of test results. Patients and clinicians however are interested in rapid, reliable and efficient service from laboratory. Turn around time (TAT), the timeliness with which laboratory personnel deliver test results, is one of the most noticeable signs of laboratory service and is often used as a key performance indicator of laboratory performance. This study is aims to provide clue for laboratory TAT monitoring and root cause analysis. In a 2 year period a total of 75,499 specimens of outdoor patient department were monitor, of this a total of 4,142 specimens exceeded TAT. With consistent efforts to monitor, root cause analysis and corrective measures, we are able to decreased the specimens exceeding TAT from 7–8 to 3.7 %. Though it is difficult task to monitor TAT with the help of laboratory information system, real time documentation and authentic data retrievable, along with identification of causes for delays and its remedial measures, improve laboratory TAT and thus patient satisfaction.  相似文献   

7.

Introduction

In vitro human diagnostic (IVD) company recalls are a common practice aimed to either minimize a potential error or eliminate an existing failure. In this case report, we aim to provide a critical analysis of a recent IVD recall and to provide a practical framework about what to do when an IVD company recalls product(s) based on the International Organization for Standardization - ISO 15189:2012 standard.

Case report

In 2014, Abbott Laboratories® (Green Oaks, IL) published an urgent field safety notice regarding a product recall (Architect Intact parathyroid hormone (PTH) Assay List Number 8K25) with immediate action required. The IVD company explained the reasons for the recall as follows: i) Abbott has confirmed that a performance shift in the Architect Intact PTH assay has the potential to generate falsely elevated results on patient samples; ii) results generated with impacted lots may demonstrate a positive shift relative to those generated with previous reagent and/or calibrator lots. This issue may also impact established Architect Intact PTH reference ranges; iii) the magnitude of shift averages approximately 13% to 45%; iv) Abbott Architect Intact PTH controls do not detect the shift; and v) all current reagent, calibrator, and control inventory are impacted. The recall could have resulted in ~40,000 inaccurate laboratory tests reported by 18 laboratories from Italy (Lombardy region).

Conclusion

IVD company recalls have a serious impact on the patient safety and require a thorough investigation and responsible approach to minimize the possible damage. Medical laboratories accredited according to the ISO 15189 standard have procedures in place to manage such situations and ensure that patient safety is maintained when such recalls are issued.Key words: clinical laboratory techniques, patient safety, laboratory variability, reference standards, quality control, parathyroid hormone  相似文献   

8.
Errors in laboratory medicine occur in the preanalytical, analytical, and postanalytical phases. The errors are mostly detected in the preanalytical period. However, analytical errors are still an important source of error, despite their frequency is reduced significantly in years thanks to developments in laboratories. In this case, an analytical error was noticed during the verification of a patient’s results. The direct bilirubin of a 66-year-old male patient admitted to the emergency department was higher than the total bilirubin. The patient’s symptoms were fatigue and dyspnoea. Albumin and haemoglobin (Hb) concentrations of the patient were significantly low. After considering the patient’s demographics and laboratory results, the laboratory specialist suspected a paraproteinemia interference. Total protein was performed as a reflective test. The albumin/globulin ratio was reversed. Thereafter, serum protein electrophoresis (SPEP) and immunofixation electrophoresis (IFE) were performed as another reflective tests, respectively. SPEP and IFE results were in favour of monoclonal gammopathy. The patient was directed to a haematologist, underwent a bone marrow biopsy, and the result was reported as Waldenstrom’s macroglobulinemia with plasma cell differentiation expressing IgM-Kappa. The patient went on a chemotherapy protocol, and his condition has been improved in subsequent months. Detection of analytical errors is of great importance, like in our case, and may be used as a tool to identify patients who have not yet been diagnosed. The laboratory specialist must dominate the entire process of each test in the laboratory, be aware of the limitations of tests, and turn these disadvantages into advantages when necessary.  相似文献   

9.

Introduction

To investigate the state of the art of intra-laboratory turnaround time (intra-TAT), provide suggestions and find out whether laboratories accredited by International Organization for Standardization (ISO) 15189 or College of American Pathologists (CAP) will show better performance on intra-TAT than non-accredited ones.

Materials and methods

479 Chinese clinical laboratories participating in the external quality assessment programs of chemistry, blood gas, and haematology tests organized by the National Centre for Clinical Laboratories in China were included in our study. General information and the median of intra-TAT of routine and stat tests in last one week were asked in the questionnaires.

Results

The response rate of clinical biochemistry, blood gas, and haematology testing were 36% (479 / 1307), 38% (228 / 598), and 36% (449 / 1250), respectively. More than 50% of laboratories indicated that they had set up intra-TAT median goals and almost 60% of laboratories declared they had monitored intra-TAT generally for every analyte they performed. Among all analytes we investigated, the intra-TAT of haematology analytes was shorter than biochemistry while the intra-TAT of blood gas analytes was the shortest. There were significant differences between median intra-TAT on different days of the week for routine tests. However, there were no significant differences in median intra-TAT reported by accredited laboratories and non-accredited laboratories.

Conclusions

Many laboratories in China are aware of intra-TAT control and are making effort to reach the target. There is still space for improvement. Accredited laboratories have better status on intra-TAT monitoring and target setting than the non-accredited, but there are no significant differences in median intra-TAT reported by them.Key words: quality indicators, quality control, clinical laboratory services  相似文献   

10.
Quality in laboratory has huge impact on diagnosis and patient management as 80–90% of all diagnosis is made on the basis of laboratory tests. Monitoring of quality indicators covering the critical areas of pre-analytical, analytical and post-analytical phases like sample misidentification, sample rejection, random and systemic errors, critical value reporting and TATs have a significant impact on performance of laboratory. This study was conducted in diagnostic laboratories receiving approximately 42,562 samples for clinical chemistry, hematology and serology. The list of quality indicators was developed for the steps of total testing process for which errors are frequent and improvements are possible. The trend was observed for all the QI before and after sensitisation of the staff over the period of 12 months. Incomplete test requisition form received in the lab was the most poor quality indicator observed (7.89%), followed by sample rejection rate (4.91%). Most significant improvement was found in pre- and post-analytical phase after sensitisation of staff but did not have much impact on analytical phase. Use of quality indicators to assess and monitor the quality system of the clinical laboratory services is extremely valuable tool in keeping the total testing process under control in a systematic and transparent way.  相似文献   

11.
金冶  曹利平 《科技通报》2007,23(5):684-688
普外科腹部手术后的病人存在较高的发生静脉血栓栓塞(Venous Thromboembolism,VTE)的风险,经过最近几年的研究发现,在预防术后血栓的药物中,低分子肝素(LMWH)可能比普通肝素等其他药物更优越,在西方国家低分子肝素现已成为术后预防血栓性疾病的首选药物。  相似文献   

12.
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.  相似文献   

13.
In laboratory medicine, several studies have described the most frequent errors in the different phases of the total testing process, and a large proportion of these errors occur in the pre-analytical phase. Schemes for registration of errors and subsequent feedback to the participants have been conducted for decades concerning the analytical phase by External Quality Assessment (EQA) organizations operating in most countries. The aim of the paper is to present an overview of different types of EQA schemes for the pre-analytical phase, and give examples of some existing schemes. So far, very few EQA organizations have focused on the pre-analytical phase, and most EQA organizations do not offer pre-analytical EQA schemes (EQAS). It is more difficult to perform and standardize pre-analytical EQAS and also, accreditation bodies do not ask the laboratories for results from such schemes. However, some ongoing EQA programs for the pre-analytical phase do exist, and some examples are given in this paper. The methods used can be divided into three different types; collecting information about pre-analytical laboratory procedures, circulating real samples to collect information about interferences that might affect the measurement procedure, or register actual laboratory errors and relate these to quality indicators. These three types have different focus and different challenges regarding implementation, and a combination of the three is probably necessary to be able to detect and monitor the wide range of errors occurring in the pre-analytical phase.  相似文献   

14.
国家实验室建设已成为我国推进创新型国家和科技强国建设的重要举措,迫切需要在管理体制机制上,特别是经费配置与管理方面进行革新。这不仅是我国国家实验室建设需要考虑的基本问题之一,也是国家实验室拟突破现有科研机构瓶颈的重要切入点。我国国家实验室建设的初级阶段迫切需要借鉴国际经验,而美国国家实验室管理与发展已较为成熟,具有重要借鉴意义。本文从财务管理视角切入,通过详细梳理美国国家实验室经费配置与管理特点,对我国拟筹建的国家实验室及科研机构经费配置与管理现状进行深入细致分析,旨在为建设我国国家实验室提出科学可行的建议。研究发现美国国家实验室以联邦政府资助为主的经费分配模式、全程多元监管体系、精准的绩效预算模式等卓有成效。建议我国国家实验室的经费配置遵循以任务为导向的原则,采用弹性制经费分配模式,完善管理程序和立法内容,辅以多元主体共同监督的模式,促使国家实验室经费配置与管理的规范化、制度化,进而提升经费的配置效率。  相似文献   

15.
Clinicians request a large part of measurements of biological quantities that clinical laboratories perform for diagnostic, prognostic or diseases monitoring purposes. Thus, laboratories need to provide patient’s results as reliable as possible. Metrological concepts like measurement uncertainty and metrological traceability allow to know the accuracy of these results and guarantee their comparability over time and space. Such is the importance of these two parameters that the estimation of measurement uncertainty and the knowledge of metrological traceability is required for clinical laboratories accredited by ISO 15189:2012. Despite there are many publications or guidelines to estimate the measurement uncertainty in clinical laboratories, it is not entirely clear what information and which formulae they should use to calculate it. On the other hand, unfortunately, there are a small number of clinical laboratories that know and describe the metrological traceability of their results, even though they are aware of the lack of comparability that currently exists for patient’s results. Thus, to try to facilitate the task of clinical laboratories, this review aims to provide a proposal to estimate the measurement uncertainty. Also, different suggestions are shown to describe the metrological traceability. Measurement uncertainty estimation is partially based on the ISO/TS 20914:2019 guideline, and the metrological traceability described using the ISO 17511:2020. Different biological quantities routinely measured in clinical laboratories are used to exemplify the proposal and suggestions.  相似文献   

16.

Introduction:

The aim of this survey study was to assess the current practices and policies in use related to the various steps in the blood gas testing process, across hospital laboratories in Croatia.

Materials and methods:

First questionnaire was sent by email to all medical biochemistry laboratories (N = 104) within general, specialized and clinical hospitals and university hospital centres to identify laboratories which perform blood gas analysis. Second questionnaire with detailed questions about sample collection, analysis and quality control procedures, was sent only to 47 laboratories identified by the first survey. Questionnaire was designed as combination of questions and statements with Likert scale. Third questionnaire was sent to all participating laboratories (N=47) for additional clarification for either indeterminate or unclear answers.

Results:

Blood gas analysis is performed in 47/104 hospital laboratories in Croatia. In 25/41 (0.61) of the laboratories capillary blood gas sampling is the preferred sample type for adult patient population, whereas arterial blood sample is preferentially used in only 5/44 laboratories (0.11). Blood sampling and sample processing for capillary samples is done almost always by laboratory technicians (36/41 and 37/44, respectively), whereas arterial blood sampling is almost always done by the physician (24/29) and only rarely by a nurse (5/28). Sample acceptance criteria and sample analysis are in accordance with international recommendations for majority of laboratories. 43/44 laboratories participate in the national EQA program. POCT analyzers are installed outside of the laboratory in 20/47 (0.43) institutions. Laboratory staff is responsible for education and training of ward personnel, quality control and instrument maintenance in only 12/22, 11/20 and 9/20 institutions, respectively.

Conclusions:

Practices related to collection and analysis for blood gases in Croatia are not standardised and vary substantially between laboratories. POCT analyzers are not under the direct supervision by laboratory personnel in a large proportion of surveyed institutions. Collective efforts should be made to harmonize and improve policies and procedures related to blood gas testing in Croatian laboratories.  相似文献   

17.
Improving specimen quality as well as healthcare worker (HCW) safety poses significant concerns for today’s laboratories. With an increasing number of diagnostic tests requested, laboratory professionals are faced with challenges to reduce laboratory errors, improve the quality of laboratory results to assure accurate diagnosis and implement initiatives to ensure healthcare worker safety and minimize risk of exposure to bloodborne pathogens. A prior study conducted in 2008 reported that variations in blood collection methods for clinical chemistry assays may affect overall specimen quality. As a follow up, the current study assessed the quality of 22563 patient specimens for cell counting in EDTA blood collection tubes that were obtained with needle and syringe collection (open) using either disposable tubes or re-washed glass vials or with an evacuated blood collection system (closed). Based on the observations, the use of the evacuated blood collection system resulted in better preanalytical specimen quality as compared with needle and syringe collection. The findings also showed an approximately 70-fold reduction in the incidence of clotting as well as fewer instrument-generated flags using the evacuated collection system. In addition, the use of an evacuated collection system for venous blood collection demonstrated lesser chance of blood exposure to healthcare workers.  相似文献   

18.
国家实验室是面向世界科技前沿和国家战略需求开展高水平基础和应用基础研究的战略科技力量和重大原始创新的平台。如何强化目标导向的国家实验室战略性基础研究,并与产学研开展关键技术协同攻关,提高我国前沿技术和战略领域的原始创新能力,是我国国家实验室建设中亟待解决的关键问题。美国能源部国家实验室是美国开展战略性基础研究和前沿技术探索的核心力量,在世界同类机构中处于领先地位。基于基础研究投入-产出分析框架,对美国能源部国家实验室战略性基础研究组织运行模式及产出特征进行系统调研和分析,研究发现,美国能源部国家实验室基于明确的战略定位和研究方向,组织开展战略性基础研究,在经费投入结构和研发团队结构、基础研究产出水平、学科领域布局等方面各具特点;国家实验室通过与政府、非营利机构、大学和企业以及国家实验室之间的合作开展协同研究与创新,同时开展差异化的国际合作研究,形成以发达国家为主、并不断加强与中国合作的国际合作模式。研究结果对我国布局建设国家实验室、开展战略性基础研究具有重要的参鉴价值。  相似文献   

19.

Introduction:

The activities involving phlebotomy, a critical task for obtaining diagnostic blood samples, are poorly studied as regards the major sources of errors and the procedures related to laboratory quality control. The aim of this study was to verify the compliance with CLSI documents of clinical laboratories from South America and to assess whether teaching phlebotomists to follow the exact procedure for blood collection by venipuncture from CLSI/NCCLS H03-A6 - Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture might improve the quality of the process.

Materials and methods:

A survey was sent by mail to 3674 laboratories from South America to verify the use of CLSI documents. Thirty skilled phlebotomists were trained with the CLSI H03-A6 document to perform venipuncture procedures for a period of 20 consecutive working days. The overall performances of the phlebotomists were further compared before and after the training program.

Results:

2622 from 2781 laboratories that did answer our survey used CLSI documents to standardize their procedures and process. The phlebotomists’ training for 20 days before our evaluation completely eliminated non-conformity procedures for: i) incorrect friction of the forearm, during the cleaning of the venipuncture site to ease vein location; ii) incorrect sequence of vacuum tubes collection; and iii) inadequate mixing of the blood in primary vacuum tubes containing anticoagulants or clot activators. Unfortunately the CLSI H03-A6 document does not caution against both unsuitable tourniquet application time (i.e., for more than one minute) and inappropriate request to clench the fist repeatedly. These inadequate procedures were observed for all phlebotomists.

Conclusion:

We showed that strict observance of the CLSI H03-A6 document can remarkably improve quality, although the various steps for collecting diagnostic blood specimens are not a gold standard, since they may still permit errors. Tourniquet application time and forearm clench should be verified by all quality laboratory managers in the services. Moreover, the procedure for collecting blood specimens should be revised to eliminate this source of laboratory variability and safeguard the quality.  相似文献   

20.

Introduction

Early identification and management of chronic kidney disease (CKD) is highly cost-effective and can reduce the risk of kidney failure progression and cardiovascular disease. In 2014, the Joint Croatian Working Group (JCWG) for laboratory diagnostic of CKD on the behalf of Croatian society of medical biochemistry and laboratory medicine (CSMBLM) and Croatian chamber of medical biochemists (CCMB) conducted a survey across Croatian medical-biochemistry laboratories to assess the current practice in this area of laboratory medicine. The aim of this study was to present the data collected through the survey and to give insight about laboratory diagnostics of chronic kidney disease in Croatia.

Materials and methods

An invitation to participate in the survey was sent to all Croatian medical-biochemistry laboratories (N = 196). The questionnaire was designed in a form of questions and statements, with possible multiple answers, comprising 24 questions.

Results

The response rate was 80/196 (40.8%). 39 answers were from primary medical-biochemistry laboratories. 31/78 (0.40) laboratories measure creatinine with non-standardized method (uncompensated Jaffe method). 58/78 (0.74) of laboratories that measure creatinine do not report eGFR values. Similar number of laboratories (58/80, 0.73) do not measure urine albumin or protein.

Conclusions

There is a large heterogeneity among Croatian laboratories regarding measuring methods, reporting units and reference intervals (cut-off values), both for creatinine and urine albumin or protein. The two key prerequisites for CKD screening, automatic reporting of eGFR and albuminuria or proteinuria assessment, are not implemented nationwide. There is a need for harmonization in laboratory diagnostics of CKD in Croatia.Key words: survey, chronic kidney disease, estimated glomerular filtration rate (eGFR), albuminuria, proteinuria, creatinine, harmonization  相似文献   

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