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...

Children are not just small adults, and present unique challenges to the clinical laboratory. Blood specimens must be very small; for example, total blood volumes in a premature infant can be as small as 115 mL. Genetic diseases frequently must be detected in the newborn period. Reference values change with age....

Both high and low blood glucose levels may be dangerous to the newborn baby. Measurement of blood or plasma lactate concentrations gives an indication of the adequacy of oxygen delivery to tissues, and blood and CSF lactate levels are essential investigations in the diagnosis of inborn errors of metabolism (IEM)....

The intraoperative monitoring of the partial pressure of carbon dioxide in arterial blood (pCO₂) is used to assess the adequacy of ventilation and guide clinical interventions.  Although end-tidal CO₂ monitoring remains the most frequently used non-invasive technology in the intraoperative setting to provide a...

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...

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...

Whether performed by one "traditional" or several "point-of-care" devices, all Multi-Profile Blood Gas (MPBG) results must be accurate and precise if they are to be effective in managing critically ill patients. Optimal analytical quality control of multi-profile blood gas analysis requires a good quality assurance...

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.

What quality is being controlled in laboratories today?  The definition of a quality requirement for each laboratory test is the starting point of quantitative quality management. Different types of requirements may be used as long as there are appropriate quality-planning models for translating those requirements...