CLSI H 21-A5 PDF

CLSI HA5 Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays;. CLSI HA5. Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays; Approved Guideline. HA5 does not provide general guidelines for the performance of coagulation testing. Performance guidelines for specific coagulation assays are addressed.

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Haemolysis of blood samples has been documented as the most frequent pre-analytical artefact encountered by laboratories. The interference can be the result of various mechanisms including:.

The interference with immunoassays is less frequent than with photometric assays, but is still a significant consideration; one of 21-x5 most commonly affected immunoassays are the cardiac Troponin assays. A survey of Australian Laboratories cldi in 21-5a RCPA Quality Assurance Programs confirmed an ongoing variation in the management and reporting of haemolysed samples.

This consensus statement is primarily intended as a guideline for diagnostic pathology laboratories undertaking any analyses performed on serum or plasma samples. However, these guidelines may also be considered for other sample types e. Laboratories must be familiar with best practice collection processes. The most frequently encountered causes of haemolysis of blood samples include use of inappropriately small gauge needles during phlebotomy and transfer of blood from a syringe into a vacutainer tube via a needle e.

Laboratories must monitor the frequency of haemolysed blood samples and investigate the source of collection to enable continuous improvement. Where semi-quantitative estimates are in use, their equivalence to a conventional unit e. The H-index at which a clinically relevant effect is seen must be determined for each method in use.

Clinically relevant limits can be sourced from:. Cut-offs at which assays are affected must be reviewed and updated when analytical platforms are changed.

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Where multiple different analytical platforms are in use, for example across a network of laboratories or in a large central laboratory, laboratories must ensure H-Index thresholds are appropriate for each.

A clear statement describing the magnitude and direction of the interference must be included. This decision should be guided by a policy developed in consultation with requesting clinicians. Similarly, brown coloured serum due to methaemalbumin, normal results for potassium or the same result from arterial and venous collections should prompt further investigation e.

When a POCT result shows a result e. Areas to consider could include data mining, guidance on how to perform in-house studies and the defining of appropriate action limits. Example of a Haemolysis Colour Chart which also shows haemolysis index concentration levels across different analytical platforms Courtesy Goce Dimeski, Pathology Queensland. National Center for Biotechnology InformationU.

Consensus Statement for the Management and Reporting of Haemolysed Specimens

Journal List Clin Biochem Rev v. Find articles by Ken Sikaris. Author information Copyright and License information Disclaimer. The contents of articles or advertisements in The Clinical Biochemist — Reviews are not to be construed as official statements, evaluations or endorsements by the AACB, its official bodies or its agents. Statements of opinion in AACB publications are those of the contributors.

No literary matter in The Clinical Biochemist — Reviews is to be reproduced, stored in a retrieval system or transmitted in any form by electronic or mechanical means, photocopying or recording, without permission. Requests to do so should be addressed to the Editor. ISSN — Introduction Haemolysis of blood samples has been documented as the most frequent pre-analytical artefact encountered by laboratories.

The interference can be the result of various mechanisms including: Additive – as result of greater concentrations of analytes in cells than in plasma e. Spectral haemoglobin absorbs atand nm – leading to interference with alkaline phosphatase, gamma-glutamyl transferase, total and direct bilirubin. Enzymatic – release clwi enzymes which degrade analytes e. Dilutional gross haemolysis releasing cell fluid and content – leading to false lowering of results e.

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Best Practice Collection Technique S1. Best Practices in Phlebotomy Factors Affecting Haemolysis, specimencare. This is a useful website featuring a variety of pre-analytical issues with blood csli, sponsored by Becton Dickinson.

Quantitative Estimation of Haemolysis S2. Non standardisation of units.

Impact of Haemolysis on Test Results S3. Clinically relevant limits can be sourced from: Published clinical outcome studies describing performance requirements for the specific analyte. Actions in Response to Haemolysis S4. Laboratories must have a means to identify affected patient results e. Laboratories must determine and document at which H-Index clsu recollection of the sample is appropriate.

If a laboratory decides to report affected tests, the H-Index levels used for these purposes must be documented. Whole Blood Analyses S5.

Consensus Statement for the Management and Reporting of Haemolysed Specimens

Appendix Example of a Haemolysis Colour Chart which also shows haemolysis index concentration levels across different analytical platforms Courtesy Goce Dimeski, Pathology Queensland.

Open in a separate window. Errors in laboratory medicine. Influence of hemolysis on routine clinical chemistry testing.

Clin Chem Lab Med. Haemolysis as influence and interference factor. The effect of hemolysis on current troponin assays confounding preanalytical variable?

Best Practices in Phlebotomy. Observational study to determine factors associated with blood sample haemolysis in the emergency department. Ann Acad Med Singapore. Support Center Support Center. Please review clzi privacy policy.