Lot verification practices in Ontario clinical chemistry laboratories - Results of a patterns-of-practice survey.

Objectives: Verifying new reagent or calibrator lots is crucial for maintaining consistent test performance. The Institute for Quality Management in Healthcare (IQMH) conducted a patterns-of-practice survey and follow-up case study to collect information on lot verification practices in Ontario.

Methods: The survey had 17 multiple-choice questions and was distributed to 183 licensed laboratories.

Role of a quality management system in improving patient safety - laboratory aspects.

Objectives: The aim of this study is to describe how implementation of a quality management system (QMS) based on ISO 15189 enhances patient safety.

Design And Methods: A literature review showed that several European hospitals implemented a QMS based on ISO 9001 and assessed the impact on patient safety. An Internet search showed that problems affecting patient safety have occurred in a number of laboratories across Canada.

A randomised controlled trial of biopsy forceps and cannula aspiration for transcervical chorionic villus sampling.

Objective: This trial compared two instruments for transcervical chorionic villus sampling (CVS).

Design: Randomised controlled trial.

Setting: Regional university prenatal diagnosis and treatment centre.

IFCC handbook on Master Program in clinical laboratory sciences.

This document summarizes the steps in development of a new IFCC Master Program and outlines some of the ways the IFCC would assist in setting up such a regional Program. This is intended to be of assistance to those who wish to embark on such an endeavour.

Analytical evaluation of hemoglobin A(1c) dual kit assay on Bio-Rad Variant II: an automated HPLC hemoglobin analyzer for the management of diabetic patients.

Objectives: To evaluate the analytical performance of the Bio-Rad Variant II HbA(1c) dual kit assay.

Design And Methods: Precision, carryover, linearity and analytical range were investigated. 139 patients' HbA(1c) results analyzed by the Variant II were compared to the Variant I method.

Outcome validation of the Beckman Coulter access analyzer in a second-trimester Down syndrome serum screening application.

Background: Mid-trimester maternal serum alpha-fetoprotein (AFP) and unconjugated estriol (uE3) are 30% lower and human chorionic gonadotropin (hCG) is twofold higher in Down syndrome pregnancies compared with unaffected pregnancies. In maternal serum screening, patient-specific risks are calculated using published gaussian frequency distribution parameters for these three markers obtained with previously available immunoassays. New immunoassays must generate similar distribution parameters if the accuracy of assigned risks and overall performance of prenatal screening are to be maintained.