Pdf preanalytical phase in clinical chemistry laboratory. These lists illustrate the use of the pre pre and postpost analytical categories note, for example, that plebani includes choice of container, collection, handling and transportation as pre pre analytical activities, resulting in most errors being categorised as pre pre analytical rather than pre analytical. Pdf preanalytical phase is the most vulnerable part of the total testing process and is considered to be among the greatest challenges to the. Such errors in preanalytical stage often only become apparent in the analytical or postanalytical phase. However, preanalytical activities, management of unsuitable specimens and reporting policies are not fully standardized, nor harmonized worldwide. Errors in clinical laboratories or errors in laboratory. Pdf on jun 17, 2018, rateesh sareen and others published pre analytical phase. Although many kinds of errors can be detected with various methods in laboratory practice, the laboratory staff focuses on. Objectives list the three different phases of the testing process and. B with a fully automatic c or manual d tissue arrayer. Major sources of preanalytical errors include inappropriate. Lds standard analytic files safs, also known as medicare claims files, are available for each claim type inpatient, outpatient, skilled nursing facility, home health agency, hospice, carrier and durable medical equipment.
For example, if a 5 ml draw heparin tube is only filled. Potential for pre analytical and analytical contributing factors. Principles of pre analytic and postanalytic test management dr varsha shahane slideshare uses cookies to improve functionality and performance, and to provide you with relevant advertising. Meanwhile, errors occurring during the preanalytical from the time the test is ordered by the. Mullier1 abstract ensuring quality has become a daily requirement in laboratories. Rose romeo, phd, dabcc, facb redwood city, ca 94065. Each person involved at this time, must be aware of the significance of preanalytics, and that if errors are made during this phase, the laboratory result could become meaningless.
However, preanalytical activities, management of unsuitable specimens and reporting policies are. Quality assurance in the hematology laboratory is a must to ensure laboratory users of reliable test results with high degree of precision and accuracy. This will ensure the proper amount of blood for the amount of additive in the tube blood to additive ratio. Quality assurance of the preanalytical phase complying. Pdf analysis of the preanalytical phase in a private pathology. Errors in clinical laboratories or errors in laboratory medicine. Errors in this phase generally occur from high personnel turnover rates, negligence, lack of understanding about good laboratory practices, and ineffective training8, 12. Preanalytical issues in the haemostasis laboratory. The magnitude of preanalytical errors was accurately valued. Wgpre was officially established by the european fed eration of clinical chemistry and. This phase may include specimen handling issues that occur even prior to the time the specimen is received in the laboratory. Since evidence based medicine ebm is now become the main principle guiding clinical practice and is being followed universally the role of laboratory medicine in ebm needs not to be overemphasized.
The pre analytic phase of the total testing process t. For any further enquiry, please contact the organising secretariat at. The preanalytic phase is an important component of total laboratory quality. By continuing to visit the site, the user accepts the use of cookies. P begins with the encounter between the clinician and the patient,and includes verification of identity, specimen processing, specimen preparation, the posing of clinical question, test selection according to the questions, test ordering, patientspecimen identification, specimen collection, handling and transportation of the specimen. If you continue browsing the site, you agree to the use of cookies on this website. Quality assurance of the postanalytical phase can be implemented in the usual external quality assurance eqas as peqas. The validity of results generated for patient sample results. The preanalytical phase encompasses the procedures prior to the performance of the laboratory tests, which are the physicians. Preanalytical, analytical, and postanalytical phases of. The eflm strategy for harmonization of the preanalytical phase. Pdf preanalytical errors management in the clinical laboratory. The intention of this brochure is to increase awareness of the possibilities for making errors.
Preanalytical phase errors account for approximately 60%70% of laboratory errors. Pdf preanalytical errors in hematology laboratory an. Protein and phosphoprotein stability during the pre. Pdf assessment of the preanalytical phase of a clinical. The preanalytical phase of pathology research and diagnostics.
There have been major advances in technology with tight quality control procedures in place for the analytical phase of testing. To evaluate the frequency of preanalytical errors in the clinical laboratory service of a military hospital. The development of a preanalytical quality manual is. Routine coagulation testing is an integral part of laboratory testing that informs clinical decision making. Protein and phosphoprotein stability during the pre analytical phase 1. Patient identification, specimen collection, handling and transport.
The use of indicators in the preanalytical phase as a laboratory. Technologies resolving the pre analytical phase of the diagnostic test interface with the patient, from whom the specimen is obtained, the user, who utilizes the technology to collect the specimen and process it, and the analytical test, which requires the analyte to be appropriately conditioned. Information and translations of preanalytical in the most comprehensive dictionary definitions resource on the web. All the activities focus on the validation of the translational research providing tools for the pre analytical phase of in vitro diagnostics. Phlebotomist pre analytical tech unregistered or with. It is of crucial importance that the pre analytical phase does not influence the desired results. 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. Volume 47, issues 1617, november 2014, pages 233236. The phlebotomy staff and all the standard operating procedures for veni.
A wide range of variables that affect the result for a patient from whom a specimen of blood or body fluid has been collected, including the procedure for collection, handling, and processing. The overall rate of critical preanalytical errors was 0. Reducing preanalytical errors whitehat communications. Analysis of the preanalytical phase in a private pathology. Pre analytical variability currently represents the most important source of errors that can lead to inaccurate patient results in monitoring of patients being treated with oral. Variables in the preanalytical work flow of tissue based diagnostics and research. Managing the pre and postanalytical phases of the total. Mario plebani department of laboratory medicine, university hospital of padova and center of biomedical research, castelfranco veneto, italy abstract laboratory testing is a highly complex process and, although laboratory services are. Potential errors in obtaining and reporting a blood gas result pre analytical analytical. The importance of preanalytical phase in laboratory. The majority of errors in ttp originate in the pre analytical phase, being due to individual or system design defects. Tables 1 3 contain a list of the most common er rors in hematology and biochemical analyzers.
Compiled as individual biosimilar cmc analytical master files, these resources are valuable and unique guides to support your biosimilar program throughout its development and product lifecycle. In order to reduce errors in ttp, the pre analytical phase should therefore be. The study was carried out using blood collection tubes produced by the same manufacturer kima, padova, italy and was extended throughout a comparable period of time i. We use cookies to help you use the site and optimize your browsing experience. Preanalytical phase an overview sciencedirect topics. To assess the preanalytical phase of a public laboratory through quality. Preanalitycal phase quality assurance for laboratory. Preanalytical errors before and after implementation of an.
The preanalytical phase involves most of the errors of clinical analysis. Pdf fases preanalitica, analitica e posanalitica no. The use of indicators in the preanalytical phase as a. Pre analytical analytical post analytical problems that can occur prior to the actual analysis of the specimen. Management of the quality in the preanalytical phase. The importance of preanalytical phase in laboratory testing tryb. As the analytical quality now is improving and under control, more and more focus should be given to the pre and postanalytical phase. Clinical practice guidelines clinical practice guidelines.
I glean from a lot of resources, but i always seek to create my own material. Adinaroc the purpose of this study was to determine. Evidencebased guidelines for the preanalytical phase of. Effects of preanalytical variables on the antiactivated. In this thesis a number of experiments on many levels e. Integrating research techniques to improve quality and safety in. Submission of analytical procedure development and related information in ctd format the concept and strategy of enhanced approaches for analytical procedures performance criteria of analytical procedures. The preanalytical influence of exercise moderate to strenuous exercise can change the laboratory test results ck, ua, ldh, cortisol,acth,creatinine will change in blood levels due to physical exercise e. The evaluation of error types and turnaround time of preanalytical. Studies indicate that approximately 40% to 70% of errors occur in the pre analytical phase 1, 3, 7, 8, 15, 16, 21.
The seismic zone of clinical laboratory testing find. Effects of pre analytical variables on the antiactivated factor x chromogenic assay when monitoring unfractionated heparin and low molecular weight heparin anticoagulation david l. Pols en volgens besluit van het college van promoties. Our many years of experience specializing in pre and postanalytics mean that we are able to respond to individual, complex laboratory requirements and offer customerspecific automation solutions for the laboratory processes in question. Review open access pre analytical issues in the haemostasis laboratory. The existence of errors in the preanalytical phase is a widely studied. Even after so many advances in hematology laboratory practice, preanalytical errors remain a challenge for practicing pathologists. The preanalytic testing phase occurs first in the laboratory process. In line with ich q8 and ich q11, greater understanding of analytical procedure can. Identify key components of pre analytic testing provide examples how pre analytic issues evolve with changes in technology compare and contrast pre analytical aspects of sample management. Preanalytical errors management in the clinical laboratory. Disclaimer no claims of absolute originality are made for this material. Preanalytical phase is the most vulnerable part of the total testing process and is considered to be among the greatest challenges to the laboratory professionals.
Quality assurance of the preanalytical phase complying with iso 15189. Pdf preanalytical phase a continues challenge for laboratory. All blood collection tubes need to be filled to the correct volume. Important errors can occur during the preanalytic phase with specimen handling and identification. Identification of the types and frequencies of preanalytical errors. Preanalytical variability currently represents the most important source of errors that can lead to inaccurate patient results in monitoring of patients being treated with oral.
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