Design, implementation and results of the quality control program for the Australian government’s point of care testing in general practice trial

This version was published on 1 September 2009

Ann Clin Biochem 2009;46:413-419
doi:10.1258/acb.2009.009045
© 2009 Association for Clinical Biochemistry

 

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Original Articles


Mark Shephard1,
Anne Shephard1,
Les Watkinson1,
Beryl Mazzachi1 and
Paul Worley2


1 Community Point-of-Care Services, Flinders University Rural Clinical School;
2 School of Medicine, Flinders University, GPO Box 2100, Adelaide, South Australia, Australia


Corresponding author: Dr Mark Shephard, Director and Senior Research Fellow, Community Point-of-Care Services, Flinders University Rural Clinical School, Flinders University, GPO Box 2100, Adelaide, South Australia, Australia. Email: mark.shephard{at}flinders.edu.au


Background: From 2005 to 2007 the Australian Government funded a multicentre,clustered randomized controlled trial to determine the clinicaleffectiveness, cost-effectiveness, satisfaction and safety ofpoint of care testing (PoCT) in general practice (GP). PoC testsmeasured (and devices used) in the trial were haemoglobin A1cand urine albumin:creatinine ratio (DCA 2000), lipids (CholestechLDX) and international normalized ratio (CoaguChek S).

Methods: An internal quality control (QC) program was developed as partof a quality management framework for the trial. PoCT deviceoperators were provided with a colour-coded QC Result Sheetand QC Action Sheet for on-site recording and interpreting oftheir results. Within-practice imprecision for QC testing wascalculated and compared with the analytical goals for imprecisionset prior to the trial.

Results: The average participation rate for QC testing was 91% or greater.Median within-practice imprecision met the analytical goalsfor all PoC tests, except for high-density lipoprotein-cholesterol(HDL-C) where observed performance was outside the minimum goalfor one level and one lot number of QC. Most practices achievedthe imprecision goals for all analytes, with the principal exceptionof HDL-C.

Conclusions: Results from QC testing indicate that PoCT in the GP trial metthe analytical goals set for the trial, with the exception ofHDL-C.


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