BACKGROUND Glucose meter analytical performance criteria required for safe and effective management of patients on tight glycemic control (TGC) are not currently defined. We used simulation modeling to relate glucose meter performance characteristics to insulin dosing errors during TGC. METHODS We used 29,920 glucose values from patients on TGC at 1 institution to represent the expected distr...

In this issue of CCLM, a contribution from Prof. James West-gard (1) rekindles the debate, started 10 years ago by Dr. Dybkaer (2, 3), who opposed total error and the uncertainty of measurements performed in clinical laboratories. In agreement with the ISO 15189 standard (4), both scientists agree in principle that laboratories should know the uncertainty of their results for assessing whether ...

In a simultaneous paired approach to closely-spaced parallel runways, a pair of aircraft flies in close proximity on parallel approach paths. The aircraft pair must maintain a longitudinal separation within a range that avoids wake encounters and, if one of the aircraft blunders, avoids collision. Wake avoidance defines the rear gate of the longitudinal separation. The lead aircraft generates a...

The quality of laboratory analytical performance required to support medical decision-making has been defined in four major ways: (a) by the analytical variance of the state of the practice; (b) by the total variance, including analytical and biological variability; (c) by the loss of diagnostic efficiency attributable to analytical error; and (d) by medical-usefulness criteria. From the federa...

Laboratory testing is a highly complex process and, although laboratory services are relatively safe, they are not as safe as they could or should be. Clinical laboratories have long focused their attention on quality control methods and quality assessment programs dealing with analytical aspects of testing. However, a growing body of evidence accumulated in recent decades demonstrates that qua...

To achieve a reliable analytical quality for both monitoring and diagnostic testing, laboratories need to fulfil the widely accepted analytical performance goals based on the biological variation of the analytes of testing. Not only is the short-term analytical performance, which regularly is assessed by internal quality control procedures, of importance, but also the long-term analytical perfo...

  Background and Objective: The reliability and validity of monitors for self-monitoring of blood glucose are debated. We evaluated the analytical performance of Accu-check Active (Boehringer Mannheim, Roche) which is one of the most commonly used monitors in Iran. Material and Methods: We compared the monitor readings with the reference values by percentage of values within...

Background and objectives: All three phases of laboratory testing are equally important for improving total quality management, but the pre-analytical phase is the most error-prone. This study aimed to determine the rate and reasons for blood sample rejection in the pre-analytical phase of laboratory testing in a referral hospital in Ruhengeri, Rwanda. Methods: This study was a cross-sectional...

Diabetes mellitus is a major global health problem. Pathology testing for hemoglobin A1c (HbA1c), lipids, and urine albumin/creatinine ratio (ACR) has an important role in the management of diabetes patients. Each of these markers can be performed by point-of-care testing (POCT). This article focuses on setting analytical goals (quality specifications) for the imprecision, bias, and total allow...