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Design, implementation and results of the quality control program for the Australian government's point of care

Mark Shephard1, Anne Shephard, Les Watkinson

  • 1Community Point-of-Care Services, Flinders University Rural Clinical School, Flinders University, GPO Box 2100, Adelaide, South Australia, Australia. mark.shephard@flinders.edu.au

Annals of Clinical Biochemistry
|July 31, 2009
PubMed

Insights

Quality control testing in a general practice trial demonstrated that point-of-care testing (PoCT) met analytical goals. Most devices performed well, with high-density lipoprotein-cholesterol (HDL-C) being the main exception.

Area of Science:

  • Clinical Chemistry
  • Health Services Research
  • Quality Management

Background:

  • A 2005-2007 Australian Government trial evaluated point-of-care testing (PoCT) in general practice (GP).
  • PoCT devices measured haemoglobin A1c, urine albumin:creatinine ratio, lipids, and international normalized ratio.
  • The trial assessed clinical effectiveness, cost-effectiveness, satisfaction, and safety of PoCT in primary care settings.

Purpose of the Study:

  • To establish and implement an internal quality control (QC) program for the general practice PoCT trial.
  • To assess the within-practice imprecision of PoCT devices used in the trial.
  • To compare observed QC performance against pre-defined analytical goals for imprecision.

Main Methods:

  • Developed an internal quality control (QC) program within a quality management framework.
  • Provided PoCT operators with color-coded QC Result and Action Sheets for on-site data recording and interpretation.
  • Calculated median within-practice imprecision for QC testing and compared it to analytical goals.

Main Results:

  • Achieved an average QC testing participation rate of 91% or higher.
  • Median within-practice imprecision met analytical goals for most PoC tests.
  • High-density lipoprotein-cholesterol (HDL-C) testing showed performance outside minimum goals for one level and lot number of QC.

Conclusions:

  • Internal QC testing indicated that PoCT in the general practice trial generally met analytical goals.
  • The primary exception to meeting analytical goals was observed with high-density lipoprotein-cholesterol (HDL-C) testing.
  • The quality management framework and QC program supported the assessment of PoCT performance in primary care.
Abstract

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