Favaloro EJ, Adcock Funk DM, Lippi G. Pre-analytical variables in coagulation testing associated with diagnostic errors in hemostasis. Zurcher M, Sulzer I, Barizzi G, Lammle B, Alberio L. Stability of coagulation assays performed in plasma from citrated whole blood transported at ambient temperature. Methods It was a retrospective study in which we analyzed the sample rejection data of hematology and chemical pathology sections from January to December 2018. Quality standards for sample collection in coagulation testing. A. Magnette, Email: moc.liamtoh@ettengam.enidnama. Summary of key pre-analytical recommendations about specimen rejection. If this is done diligently, it can be considered as one of the best screening tests of the risk of bleeding [7, 9, 10]. Global assays of hemostasis in the diagnostics of hypercoagulation and evaluation of thrombosis risk. Each laboratory should have guidelines for rejection of samples; some criteria are obligatory: inappropriate collection tubes and additives, outdated tubes, error in patient identification or lack of identification, insufficient volume, haemolysed specimens, identification of a clot, inadequate volume, haematocrit >50% or <30% for the PFA, platelet count <100,000/L for PFA and platelet aggregation All samples deemed unacceptable due to pre-analytic handling and unfulfilled transport requirements should be rejected [46, 8]. When immediate analysis is not possible, plasma is most stable when incubated at room temperature, instead of 4C or 37C, most likely because of more activation and degradation of coagulation proteins at these temperatures [2]. The .gov means its official. The findings of our search have been grouped into different subtopics. In case of testing for thrombophilia, signs of previous venous thrombosis including post-thrombotic syndrome (venous insufficiency, corona phlebectatica etc.) In case of high haematocrit, the citrate volume may be adjusted because this may also impact the citrate-calcium ratio. Lesson 6: Pre-analytical Considerations in Phlebotomy If he/she is external to the laboratory, the laboratory must provide all information necessary about good sampling practices [6, 36]. Perinatal/pediatric hemostasis subcommittees working G. ISTH/SSC bleeding assessment tool: a standardized questionnaire and a proposal for a new bleeding score for inherited bleeding disorders. Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved StandardSixth Edition. Use of combined oral contraceptives is associated with a three-to six-fold increased risk of venous thrombosis. Phlebotomy is often addressed as a crucial process in the pre-analytical phase, in which a large part of laboratory errors take place, but to date there is not yet a consolidated methodological paradigm. Mackie I, Cooper P, Lawrie A, Kitchen S, Gray E, Laffan M, British Committee for Standards in H Guidelines on the laboratory aspects of assays used in haemostasis and thrombosis. Bethesda, MD 20894, Web Policies Before blood sampling, the disturbing influences of food and drink should be excluded. History of the preanalytical phase: a personal view. Lippi G, Plebani M, Favaloro EJ. Raijmakers MT, Menting CH, Vader HL, van der Graaf F. Collection of blood specimens by venipuncture for plasma-based coagulation assays: necessity of a discard tube. 1. [. No tubes were labeled erroneously or incorrectly, even if process failure occurred in 2.8% of cases when ProTube was used. Only articles in English or French were analysed. In order to eliminate platelet debris and microparticles from plasma, which may contribute to the variability in thrombin generation results, a second centrifugation step at 10,000g is recommended [2]. Delays in transport may affect in particular the labile factors (FV, FVIII), leading to prolonged clotting times and in vitro loss of factor activity [2, 83]. Ozgonenel B, Rajpurkar M, Lusher JM. Perform blood collection from fasting subjects in the morning (between 7 and 9a.m.). An insufficient volume for testing greatly modifies the fixed blood-to-anticoagulant ratio. Freezing leads to a marked decrease especially in FVIII activity [4, 87]. A record of all the drugs that the subject took during the week prior to testing should be collected [15]. On the other hand, in this pre-analytical phase, pre-processing factors associated with the preparation of patients have generally received less scientific interest in contrast to blood samples . J Thromb Haemost. A syringe system permitting slow manual drawing of blood may be superior [4]. Pre-analytical Considerations in Phlebotomy Flashcards | Quizlet Mayo Medical Laboratories. Sandset PM. Bach J, Haubelt H, Hellstern P. Sources of variation in factor VIII, von Willebrand factor and fibrinogen measurements: implications for detecting deficiencies and increased plasma levels. This may cause haemolysis when cells under pressure from the plunger collide with the tube wall [4]. 2023;2663:39-50. doi: 10.1007/978-1-0716-3175-1_2. eCollection 2017 Apr. The diameter of the needle should preferably be comprised between 19 and 22 gauge [34, 49]. ReTweet if useful What are the pre-analytical factors related to phlebotomy? Quality and reliability of routine coagulation testing: can we trust that sample? Discard tubes are not necessary when drawing samples for specialized coagulation testing. Plasma samples frozen at minus 20C remain stable for 2weeks. Seeking literature, we found 36 suitable investigations issued between 1996 and 2016 (April) dealing with the investigation of pre-analytical factors related to phlebotomy. Armstrong E, Joutsi-Korhonen L, Lassila R. Interaction between clinic and laboratory. From: Encyclopedia of Bioinformatics and Computational Biology Related terms: Blood Sampling Laboratory Automation Risk Manag Healthc Policy. F. Mullier, Email: eb.niavuolcu@reillum.siocnarf. The database was searched for studies, clinical practice recommendations and literature reviews. These include inappropriate tests that have been ordered, improper sample collection, transport delays, and illegible handwriting on requisition slips. F. Bamforth, in Comprehensive Sampling and Sample Preparation, 2012 3.09.8.3 Sample Preparation for MS/MS. Several aliquots (suggested volume of 5001200L) should be prepared as a backup. Anticoagulation Education Task Force White Paper. B. Chatelain, Email: moc.liamg@nialetahc.dranreb. The investigation of platelets is highly vulnerable to a broad series of pre-analytical variables [8]. The Pre-analytical Phase and Importance of Minimizing Variability - LabCE Click the card to flip . Do not vortex or shake. The plasma is aliquoted to a secondary tube, taking care not to include the residual platelets that may have precipitated at the bottom of the centrifuge tube. Samples may not be re-frozen. The centrifuge should be validated before use, every 6months or after modifications, in order to assure that platelet-poor plasma (PPP) is achieved [47]. The authors declare that they have no competing interests. Before transport, test samples regarding identification, safety conditions and stability. Pappas AA, Palmer SK, Meece D, Fink LM. During the pre-analytical phase, in case of haemostasis testing for patients with a positive history of haemorrhagic diathesis, certain steps regarding the preparation of patients and the execution of sampling (specimen collection, transportation, sample preparation and storage) are of specialimportance. Pre-analytical phase: Automated ProTube device supports quality In addition to developing procedures, providing training, improving interdepartmental cooperation, information technology and robotics may be a tool to reduce errors in specimen collection and pre-analytical sample handling. Pre-analytical workstations: a tool for reducing laboratory errors Tubes should be stored at ambient temperature until centrifugation [4, 5, 36]. Ensure correct filling of tubes (>90% filling). Sometimes samples are inappropriately mixed or left unmixed for a long time, thereby avoiding full contact of the blood with the anticoagulant, which determines partial clotting. Lance MD, Marcus MA, van Oerle R, Theunissen HM, Henskens YM. Of course, the use of prebarcode tubes may facilitate collecting this information. Lack of standardized procedures for sample collection accounts for most of the errors encountered within the total testing process. 8600 Rockville Pike A systematic review was conducted following the recommendations of the French Study Group on Haemostasis and Thrombosis (GFHT), the World Health Organization (WHO), the Clinical and Laboratory Standards Institute (CLSI) guidelines, the International Society on Thrombosis and Haemostasis (ISTH), the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and the British Committee for Standard in Haematology (BCSH) about the pre-analytical phase and the pre-analytic variables which can have an impact on the quality of medical laboratory results and about the procedures for sample collection, processing, transportation, and storage in haemostasis testing. In-vitro clots may develop in samples where the blood is slow to fill the collection container, where there is prolonged use a tourniquet, or when considerable manipulation of the vein by the needle has occurred. Contamination can occur through contact from micro drops from caps with a compress, or from contact with the interior of the tube with the syringe and from the anticoagulant of the first tube to the second tube [4]. Strenuous exercise promotes shear-induced thrombin generation by increasing the shedding of procoagulant microparticles from platelets. If tubes need to be transported this should be done with care in order to avoid unnecessary agitation. The presence of the H-antigen (O group) promotes the cleavage of VWF by ADAMTS13 metalloprotease, and, moreover, a higher hepatic clearance of VWF [13, 14]. Other BS have been developed for the large population of patients with atrial fibrillation (AF) that require oral anticoagulant therapy (e.g. Clinical decisions regarding platelet function and aspirin responsiveness should not be based on blood specimens transported by a PTS [6568] (Table3). Preanalytic variables of thrombin generation: towards a standard procedure and validation of the method. contaminated, haemolysed) or quantity (e.g. Because the presence of lipid particles can still bias the measurement for biologic interference, the CLSI currently recommends the removal of excess triglycerides by ultracentrifugation [61]. However, the median effect size (ES) resulted significantly larger if the associated factor was clinically significant instead of non-significant (ES = 1.140, IQR: 0.815-1.700 and ES = 0.349, IQR: 0.228-0.531 respectively, P < 0.001). We hope that these recommendations will be a useful contribution to the . Ideally, the primary tube should be received together with the aliquot tube [39]. For some analyses, especially platelet function assays, buffered citrate solution or other anticoagulants are used. During storage, samples should remain capped [5]. The Bland-Altman plot was often the preferred method used to estimate bias (12/36), as well as the Passing-Bablok regression for agreement (8/36). The analytical phase involves the actual running of the test, while the post-analytical phase includes recording the results, interpreting the results, reporting the results to the ordering physician, and . Moreover, the largest part investigated one pre-analytical factor (26/36) and regarded more than one laboratory test (29/36), and authors preferably used paired Students t-test (17/36) or Wilcoxons test (11/36), but calibration (i.e. The pre- preanalytical phase has been described as the stage in which the requesting physician formulates the appropriate question upon which the test request is based and selects the tests to be undertaken.9 Plebani10 on the other hand de-scribes the pre- preanalytical phase as being all the steps that occur prior to receipt of the specimen by . Would you like email updates of new search results? Rodeghiero F, Castaman G, Tosetto A, Batlle J, Baudo F, Cappelletti A, Casana P, De Bosch N, Eikenboom JC, Federici AB, Lethagen S, Linari S, Srivastava A. sharing sensitive information, make sure youre on a federal Some factors can alter the result of a sample constituent after collection during transportation, preparation and storage. Thaw samples rapidly at 37C (to prevent denaturing fibrinogen) at least 5min in a water bath at 37C and not at room temperature, on a bench or in a microwave oven. The questionnaire has proven to be useful for diagnostic purposes, allowing the establishment of quantitative cut-offs discriminating healthy subjects and carriers of VWD [7]. Mullier F, Bailly N, Chatelain C, Chatelain B, Dogne JM. b) For analysis in platelet-rich plasma The preparation of platelet-rich plasma (PRP) for platelet function analysis requires that centrifugation is performed at 200250g for 10min without application of a rotor brake [8, 15]. OBrien EC, Simon DN, Thomas LE, Hylek EM, Gersh BJ, Ansell JE, Kowey PR, Mahaffey KW, Chang P, Fonarow GC, Pencina MJ, Piccini JP, Peterson ED.