Quality laboratory issues in bleeding disorders

Abstract

Selected quality issues pertinent to the determination of accurate results in the haemostasis laboratory are discussed. Specifically, the implementation of a successful external quality-assessment scheme is described, including its impact on result accuracy as well as the programme's unique challenges and opportunities. Errors in the preanalytical phase of laboratory testing represent the greatest source for reporting incorrect test results. Some of the most common preanalytical errors are described including those that necessitate sample rejection. Analytical means to identify potential sources of error and analytical means to overcome particular interferences are described. Representing the most important clinical complication in the treatment of patients with haemophilia, quality issues related to determination of the presence of inhibitory antibodies against factor VIII (FVIII) are reviewed. Heat treatment of patient plasma prior to testing, particularly in patients receiving replacement FVIII concentrate or during induction of immune tolerance to achieve more accurate results is recommended, while screening activated partial thromboplastin time-based mixing tests to rule out inhibitor presence is discouraged. The initiatives presented in this review can be implemented in robust and resource restricted settings to improve the quality of laboratory testing in patients with bleeding disorders.

A survey of characteristics and current educational needs of hemophilia treatment centers within Asia Pacific

“…Although “diagnosis” was not identified as a high priority education topic across all economic capacity groups, it should be recognized that implementation of successful QA schemes will have a positive impact on accurate laboratory results and diagnosis 16, 30. We reiterate the recommendations outlined in the Asia Pacific Principles of Haemophilia Care10 and urge prioritization of the development and implementation of institutional or national protocols in hemostasis laboratories to achieve quality‐assured testing.…”

Postanalytical considerations that may improve the diagnosis or exclusion of haemophilia and von Willebrand disease

“…Failure to achieve the correct diagnosis or exclusion of VWD or haemophilia might be due to analytical issues . Sometimes assays generate inaccurate results (ie reflecting analytical errors) or have limitations in their measurement range of and/or low analytical sensitivity.…”

“…These issues may, for example, prevent correct identification of severe cases of VWD or haemophilia, being characterized by very low factor levels, typically below 1%‐2% . Less well‐recognized is the influence of preanalytical issues on diagnosing VWD or haemophilia . To address this deficiency in knowledge, we recently published an article aimed to provide an overview of important preanalytical issues affecting the diagnosis of these conditions, as well as a range of solutions that may help in mitigating or abrogating their influence .…”

“…Failure to achieve the correct diagnosis or exclusion of VWD or haemophilia might be due to analytical issues. 2,[8][9][10][11][12][13][14] Sometimes assays generate inaccurate results (ie reflecting analytical errors) or have limitations in their measurement range of and/or low analytical sensitivity. These issues may, for example, prevent correct identification of severe cases of VWD or haemophilia, being characterized by very low factor levels, typically below 1%-2%.…”

“…2 Less wellrecognized is the influence of preanalytical issues on diagnosing VWD or haemophilia. 11,13,[15][16][17] To address this deficiency in knowledge, we recently published an article aimed to provide an overview of important preanalytical issues affecting the diagnosis of these conditions, as well as a range of solutions that may help in mitigating or abrogating their influence. 18 The current narrative review aims to add to this background of knowledge by addressing issues related to the postanalytical phase, being test reporting and resultant clinical actions.…”