"Six Sigma" is the latest trend in quality management and is being widely implemented in business and industry today. Six Sigma represents an evolution of Total Quality Management (TQM), providing a more quantitative framework for evaluating process performance and clearer goals for process improvement. The...

In the U.S. all testing, including decentralized testing, is regulated according to the Clinical Laboratory Improvement Amendments of 1988 (CLIA'88). Congress passed CLIA'88 to ensure accurate, reliable, and timely test results regardless of test site. These quality control, quality assurance, and proficiency tesing...

In conjunction with Apgar scores and other parameters, umbilical-cord blood gas values are used to assess newborn respiratory status.  Paired umbilical-cord gas venous and arterial samples were collected from 200 patients to establish reference ranges for blood gas/hemoximetry parameters. Umbilical-cord samples were...

The application of transcutaneous pO₂/pCO₂ monitoring is essential in optimizing the ventilatory management of critically ill newborns. Application areas include high-frequency oscillatory ventilation initiation, transitioning modes of ventilation, and inter-facility transport.

Babies are not small adults! The potential for abnormal adaptation to life outside of the womb, changes in physiology, and a myriad of possible life-threatening clinical conditions requires an understanding of the laboratory tests needed to support these infants.  To effectively handle the unique needs of these...

Electronic fetal monitoring (EFM) during labor has been performed for 40 years. However, the specificity in diagnosing asphyxia is still insufficient. The combination of EFM and fetal scalp-blood sampling was introduced shortly after the introduction of EFM.  Although this monitoring ensures a better sensitivity and...

The concept of “metrological traceability” is important when establishing comparable clinical decision limits for a measured analyte at different hospitals within one country and in different countries.  This can only be achieved if all instrument manufacturers establish the performance characteristics of their...

How do small labs cope with the demands of modern quality assurance? In this interview, Ruth Lock, head of the laboratory of the Anesthesiology and Intensive Care Dept. of the Copenhagen County Hospital in Glostrup, Denmark, tells how her lab keeps up with demands with the help of training and quality control.

While analytical quality standards seem well established, there has been a paucity in the development of such standards for the preanalytical phase.  Technical recommendations regarding sampling, transport, and identification have been developed in national (NCCLS, DIN) and international (IFCC, ISO) consensus...

The results of laboratory tests are used in many clinical settings. In the main, results obtained in point-of-care testing (POCT) are used either in monitoring or in diagnosis. Analytical quality does affect outcomes in these clinical situations. Numerical estimates of the quality required for laboratory tests to...