41328
document
Design , implementation and results of the quality control program for the Australian government 's point of care testing in general practice trial . BACKGROUND From 2005 to 2007 the Australian Government funded a multicentre , clustered randomized controlled trial to determine the clinical effectiveness , cost-effectiveness , satisfaction and safety of point of care testing ( PoCT ) in general practice ( GP ) . PoC tests measured ( and devices used ) in the trial were haemoglobin A1c and urine albumin : creatinine ratio ( DCA 2000 ) , lipids ( Cholestech LDX ) and international normalized ratio ( CoaguChek S ) . METHODS An internal quality control ( QC ) program was developed as part of a quality management framework for the trial . PoCT device operators were provided with a colour-coded QC Result Sheet and QC Action Sheet for on-site recording and interpreting of their results . Within-practice imprecision for QC testing was calculated and compared with the analytical goals for imprecision set prior to the trial . RESULTS The average participation rate for QC testing was 91 % or greater . Median within-practice imprecision met the analytical goals for all PoC tests , except for high-density lipoprotein-cholesterol ( HDL-C ) where observed performance was outside the minimum goal for one level and one lot number of QC . Most practices achieved the imprecision goals for all analytes , with the principal exception of HDL-C . CONCLUSIONS Results from QC testing indicate that PoCT in the GP trial met the analytical goals set for the trial , with the exception of HDL-C .
41329
Intervention_Other
colour-coded QC Result Sheet
41330
Intervention_Other
QC Action Sheet
41331
Intervention_Educational
for
41332
Intervention_Other
on-site recording and interpreting of their results
41333
Outcome_Physical
haemoglobin A1c and urine albumin : creatinine ratio ( DCA 2000
41334
Outcome_Physical
lipids ( Cholestech LDX )
41335
Outcome_Physical
international normalized ratio ( CoaguChek S )
41336
Outcome_Other
Median within-practice imprecision
41337
Outcome_Physical
high-density lipoprotein-cholesterol ( HDL-C )
41338
Outcome_Physical
HDL-C