Preanalytical errors at the chemical pathology laboratory of. Full method validation in clinical chemistry elvar theodorsson1 bertil magnusson2 received. Currently, preanalytical errors account for up to 70% of all mistakes made in laboratory diagnostics, most of which arise from problems in patient preparation, sample collection, transportation, and preparation for analysis and storage. Postanalytical phase an overview sciencedirect topics. Methods the disqualified sample types and major causes of errors in the preanalytical phase were investigated in clinical laboratory department from september 2008 to august 2009. The focus of the conference is the quality of the preanalytical phase of the laboratory work.
Preanalytical errors in clinical chemistry laboratory. This report presents a summary of the newly revised asvcp quality assurance guidelines for control of preanalytical, analytical, and postanalytical factors for urinalysis, cytology, and clinical chemistry in veterinary laboratories and is adapted from sections 1. The preanalytical phase comprises all processes from the time a laboratory. These harsh physical forces have long been thought to contribute to preanalytical errors. Jesus alsina the spanish society of clinical chemistry committee for the extraanalytical quality assessment spain 1. The present study aims to identify preanalytical errors which results in rejection of samples in the clinical laboratory and seek solutions to limit inaccuracies. Reducing preanalytical errors whitehat communications. There has been recent interest in these errors with numerous. Layout of the preanalytical errors recording software developed in accord with the international federation of clinical chemistry and laboratory medicine ifcc quality indicators. Specimen quality plays a key role in assuring accuracy of those measurements in clinical laboratory testing. Preanalytical systems, oxford, uk 4 clinical chemistry and hematology laboratory, hospital of vicenza, vicenza, italy 5 department of medical biosciences, clinical chemistry, umea university, umea, sweden 6 medical centre haaglanden, department of clinical chemistry, the hague, the netherlands and chair of the efcc working group on accreditation. Quality control for chemistry laboratory dynacare kasper. A constant commitment should thus be given by all clinical laboratory players physicians, nurses, techni.
The goal of present research is to analyse incidence of different preanalytical errors and steps taken to prevent them during the sample processing in clinical biochemistry department during the three years period. Considering the disqualified rate of preanalytical sample in our hospital, we performed several intervention measures to improve the situation. The terms of reference of this wg are many and ambitious, encompassing i the promotion of importance of quality in the preanalytical phase. D, in accurate results in the clinical laboratory second edition, 2019. Preanalytical phase test ordered clinical response to result patient preparation taking sample transporting. Materials and methods a retrospective analysis was done assessing the preanalytical errors recorded in the chemical pathology laboratory from june 2012 to may 2016. Antonia llopis, virtudes al varez, cecilia martinezbru, ruben gomez, nuria barba, me rce ibarz, mariano cortes, montserrat ventura and m. Background laboratory testing is roughly divided into three phases. The role of preanalytical factors in immunoassays introduction measurement of biochemical markers is an important aid to clinicians in the early detection, diagnosis, monitoring, and prognosis of disease. The importance of preanalytical phase in laboratory testing. A new and effective way for preventing preanalytical laboratory errors. Clinical chemistry laboratory occur before or after the laboratory testing of samples. Preanalytical variables and factors that interfere with. Errors in clinical laboratories or errors in laboratory medicine.
Ernst mtascp, director center for phlebotomy education, inc. Pdf preanalytical errors in clinical chemistry laboratory. Giuseppe lippi, laura sciacovelli, anamaria simundic and. The classic paradigm for a wider view of errors is the total testing process ttp. However, recent studies have shown that up to 70% of analytical errors reflect the preanalytical phase. Preanalytical variables in the chemistry laboratory. Preanalytical variation includes all the steps that occur from test ordering until right before. Blood collection needles in a variety of gauges and lengths, including bd eclipse tm safety needle. Centrifugation errors such as incorrect speed, incorrect or broken tubes, erroneous temperature, and insufficient centrifugation can account for greater than 6% of all preanalytical errors.
With already existent wgs, either supported by the international federation of clinical chemistry and laboratory medicine ifcc or eflm, being focused on the analytical quality or on quality indicators see below, the aims of the eflm working group wgpreanalytical phase are to assess excellence in current preanalytical practices, identify. Diagnostic technology for minimizing preanalytical errors. Preanalytical errors that occur after specimen collection by dennis j. Sometime people quote a statistic that 40% of the errors in the laboratory are preanalytical, 40% are postanalytical, and only 20% are analytical. Diagnostic technology is increasingly sophisticated at detecting and minimizing preanalytical errors. In 2008, the international federation of clinical chemistry and laboratory medicine ifcc launched a working group named laboratory errors and patient safetywgleps, its primary goal being to identify and evaluate valuable qis and related quality specifications in order to address all the stages of the ttp. The effects of education and training given to phlebotomists.
Prior to collecting specimens for chemistry, certain patient variables need to be considered. Identification and reduction of preanalytical errors in clinical. Lipemic samples lipemic samples are often seen following collection after heavy meals or the due to pre existing metabolic. Quality indicators to detect preanalytical errors in. General chemistry technical bulletin centrifugation the. Oct 01, 2011 in a study reported in this issue of clinical chemistry, streichert et al. During this period, different types of preanalytical errors were monitored. Several studies have documented that most of the errors in the clinical laboratory occur in the pre analytical phase accounting up to 80% 2,4,6, 8, 9. A retrospective analysis of the results obtained from the clinical chemistry laboratory for errors in the preanalytical phase has been carried out to summarize data regarding the frequency of the main factors affecting the preanalytical quality of results. There are more p errors than a errors, therefore, many laboratories believe they should put a higher priority on pre and postanalytical errors than on analytical errors. Abstract there are preanalytical, analytical and post analytical factors that contribute to accurate test results in. Preanalytical errors at the chemical pathology laboratory. Identification of the types of preanalytical errors in the clinical. The international federation of clinical chemistry working group on laboratory errors and patient safety has defined a number of quality indicators for the preanalytical stage, and the adoption of harmonized definitions will support inter.
Pdf preanalytical phase in clinical chemistry laboratory. Preanalytical errors and their impact on tests in clinical laboratory practice sumera naz, 1arshad mumtaz,2 agha sadaruddin pakistan medical research council, central research centre,1 national institute of health,2 islamabad. These are analyte concentrations that do not make physiologic sense, such as a potassium level of 20 meql and calcium of 1. The preanalytical phase comprises all processes from the time a. Most analytical errors have been attributed to the analytical phase. Monitoring and reporting of preanalytical errors in. Preanalytical variables account for 3275% of laboratory errors, and encompass the time from when the test is ordered by the physician until the sample is ready for analysis. With proper training, the use of these patented label features should help to reduce errors due to label misalignment. Errors in the extraanalytical phases of clinical chemistry. Dynacare kasper laboratories, clinical chemistry department, edmonton, canada abstract this paper presents the quality control procedure internal quality control, westagard rules and external quality control for chemistry in dynacare kasper medical laboratory dkml from edmonton, canada and provide a practical approach to quality control. The working group on laboratory errors and patie nt safety of the international.
Subminiature electronicmotion and environmentalfactor recorders have been developed because this kind of information. The oneweek observation focused on 73 nurses drawing blood from 337 patients. Bowen ra, hortin gl, csako g, otanez oh, remaley at. The experience of our institution, as well as the results of an italian interlaboratory effort to detect and reduce errorsrisk of errors in laboratory medicine.
Every clinical chemistry laboratory can benefit from making use of such advances. The international federation of clinical chemistry working group on laboratory errors and patient safety has defined a number of quality indicators for the preanalytical stage, and the adoption of harmonized definitions will support interlaboratory comparisons and continual improvement. Influence of hemolysis on routine clinical chemical testing. Beginning with test ordering and ending with result reporting, ttp encompasses the preanalytical, analytical, and postanalytical phases of testing figure 1. There has been recent interest in these errors with numerous publications highlighting their. Abstractobjective to evaluate the leading causes of preanalytical errors in a clinical chemistry laboratory.
There are preanalytical, analytical and post analytical factors that contribute to accurate test results in clinical laboratories. Monitoring and reporting of preanalytical errors in laboratory medicine. Preanalytical errors in medical laboratory meeqat general hospital, 25 october 2016 by prof. A standard bloodcollection tube reduces the process time from the recommended 30 minutes of clotting followed by 10 minutes of centrifugation to 5 minutes. The importance of preanalytical phase in laboratory. With improvements in analytical techniques and efficient quality control programmes, most laboratory errors now occur in the extraanalytical phases. Misidentification and other preanalytical errors the largest number of laboratory errors occur in the preanalytical phase and are mainly due to educational and organizational reasons. The total testing process consists of various phases from the prepreanalytical to the postpostanalytical phase, the socalled braintobrain loop. To evaluate and analyse causes and prevention of preanalytical, analytical and postanalytical errors in a clinical chemistry laboratory. Factors affecting the usefulness of laboratory data may arise in any of the preanalytical, analytical or postanalytical phase of the testing cycle. Identification of the types of preanalytical errors in the. Identification of the types and frequencies of preanalytical errors. Preanalytical errors and their impact on tests in clinical.
There is now incontrovertible evidence that the preanalytical phase is the major source of errors in laboratory testing, when used for either diagnostic or research purposes. Clinical labs have several tools at their disposal to detect preanalytical errors. Preanalytical variables account for 3275% of laboratory errors, and encompass the time from when thetest is ordered by the physician until the sample is ready for analysis. The present study has been conducted in a pronounced laboratory in india. Preanalytical errors there is now incontrovertible evidence that the preanalytical phase is the major source of errors in laboratory testing, when used for either diagnostic 11 or research 12 purposes. The conference is organized by the european federation of clinical chemistry and laboratory medicine eflm. Preanalytical errors and their impact on tests in clinical laboratory practice pakistan journal of medical research, 2012 january march 29 phlebotomy practices should be adopted by all health care workers. The study intends to observe the frequency of preanalytical phase errors both inside and outside the clinical laboratory according to certain quality indicators qis. Chemistry and laboratory medicine eflm working group.
Clinical biochemistry preanalytical aspects of laboratory. The spanish society of clinical chemistry committee for the extraanalytical quality assessment spain 1. Impact of blood collection devices on clinical chemistry assays. Virology is not an exception, whereby many potential preanalytical errors are similar to those occurring in other different diagnostic areas, whilst others can be classified as specific. Misidentification and other preanalytical errors in. Evaluation of types of preanalytical errors in clinical. There have been numerous international efforts to raise awareness of the importance of the extraanalytical phase. Study on preanalytical errors in a clinical biochemistry laboratory. In a study reported in this issue of clinical chemistry. For certain chemistry analytes, such as glucose and cholesterol, patients need to be fasting absence of food and liquids for at least 12 hours prior to venipuncture. Safety blood collection sets including bd safetylok tm and bd push button. Preanalytical variables account for 3275% of laboratory errors, and encompass the time from when the test is ordered by the physician until the sample is ready.
Reengineering laboratory diagnostics for preventing preanalytical errors. Prevalence of preanalytical errors in clinical chemistry. Reduction of preanalytical errors in clinical laboratory. A blood separation device that eliminates centrifugation. Oct 21, 2016 preanalytical variables account for 3275% of laboratory errors, and encompass the time from when the test is ordered by the physician until the sample is ready for analysis. Consequently the frequency of errors in clinical lab oratories. Mar 09, 2017 preanalytical errors in medical laboratory meeqat general hospital, 25 october 2016 by prof.
The total testing process consists of various phases from the pre preanalytical to the postpostanalytical phase, the socalled braintobrain loop. Sample transportation is one of the major factors contributing to delays in returning highquality clinical laboratory results to the patient bedside. The full program is available as supplementary material. Feb 15, 2014 preanalytical errors contd patient preparation. Bd diagnostics preanalytical systems also provide a range of other products including. Preanalytical errors management in the clinical laboratory. Potential preanalytical and analytical vulnerabilities in. Simundic am cornes m grankvist k lippi g nybo m kovalevskaya s et al. It is the largest such conference in europe, which brings together more than 600 participants every second year. There are more perrors than aerrors, therefore, many laboratories believe they should put a higher priority on pre and postanalytical errors than on analytical errors. Sample testing in laboratory requires skills where errors can occur at any stage, i. Preanalytical phase in clinical chemistry laboratory article pdf.
Survey of national guidelines education and training on phlebotomy in 28 european countries. Pdf since evidence based medicine ebm is now become the main principle guiding clinical. A blood separation device that eliminates centrifugation and. Preanalytical errors introduced by sampletransportation. Preanalytical,analytical and postanalytical errors in. Failures to consider these factors do constitute errors. Pdf preanalytical errors in clinical chemistry laboratory of a.
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