Internal quality control in point-of-care testing: where's the evidence?

Abstract:

:ISO 22870 standards require protocols for performance of internal quality control for all point-of-care testing devices and training of users in its theory and practice. However, the unique setting of point-of-care testing (i.e. processes conducted by non-scientific users) means that laboratory internal quality control programmes do not easily translate to point-of-care testing. In addition, while the evidence base for internal quality control within the laboratory has been increasing, the equivalent literature surrounding point-of-care testing is very limited. This has led to wide variation in what is considered acceptable practice for internal quality control at the point of care. Indeed, it has been demonstrated that internal quality control is an area of deficiency in point-of-care testing. Internal quality control protocols used at point-of-care testing should be defined based on risk management. The protocol will therefore be dependent on analyser complexity and availability of inbuilt system checks, the risk associated with release of an incorrect patient result as well as frequency of use. The emphasis should be on designing an effective internal quality control protocol as opposed to the inherent tendency of introducing high-frequency quality control. Typically a simple pass or fail criterion is used for internal quality control in point-of-care testing based on whether internal quality control results fall within assigned ranges. While simply taught, such criteria can require broad internal quality control ranges to decrease the probability of false rejection (also reducing the probability of error detection). Customized internal quality control ranges, two-tier acceptance systems and assay-specific internal quality control can be used to improve error detection rates.

journal_name

Ann Clin Biochem

authors

Holt H,Freedman DB

doi

10.1177/0004563215615148

subject

Has Abstract

pub_date

2016-03-01 00:00:00

pages

233-9

issue

Pt 2

eissn

0004-5632

issn

1758-1001

pii

0004563215615148

journal_volume

53

pub_type

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