No abstract

As a part of a series of yearly meeting, in May 2010 over 40 medical laboratory opinion leaders, pathologists, clinical biochemists and physicians from Europe, Israel and South Africa gathered together in Bardolino, Italy to discuss issues and current challenges for laboratory medicine, including a) the use of biological variation 10 years after the Stockholm Conference; b) achieving quality in point-of-care testing; c) assessing risk and controlling sources of error in the laboratory; d) determining the appropriate frequency of quality control; and f) putting laboratory medicine at the core of patient care. The intended goal of the convocation was to give laboratory professionals from different countries and backgrounds the opportunity to share ideas, concerns and experiences in previously mentioned areas of interest. This paper provide a synopsis of the reports from each working group.

Point-of-care testing (POCT) is the fastest growing segment of a US$30 billion worldwide market. "Errors" in the testing process, as well as medical data interpretation and treatment associated with POCT, are recognized as leading to major compromises of patient safety. In today's environment, most testing errors (pre-analytical, analytical and post-analytical) can be virtually eliminated by proper design of testing systems. We cite examples of two systems that have made exceptional progress in this respect. It has been recently suggested that the basic errors associated with the testing process are amplified in the POC setting. Two of the amplifiers - incoherent regulations and failure of clinician/caregivers to respond appropriately to POCT results - lead us to recognize additional changes in today's POCT environment. The first is a willingness of manufacturers, not laboratories, to take responsibility for the quality of test results - an outgrowth of an industrial philosophy called autonomation. The second is a need to substantially modify the clinician/caregiver test utilization paradigm to take full advantage of POCT results, available on site in real time. Both have already begun to take place.

On March 14, 1990, the Centers for Disease Control and the Health Care Financing Administration published criteria for defining minimum performance in proficiency testing (PT). Using our previously described computer modeling technique, we determined the likelihood of passing PT under the new rules. The model relates combinations of intralaboratory CV and bias to PT performance criteria. For example, a laboratory with a bias of zero and an internal CV of 5% will pass a 10% fixed-limit PT criterion (i.e., the criterion for glucose analyses) 98% of the time when five samples are used. The model provides similar analyses for all PT criteria and all relevant combinations of CV and bias. The probability of passing PT decreases as the number of analytes tested increases, i.e., from 98% to 37% as the number of analytes increases from 1 to 20. A laboratory's internal CV has a greater effect on the outcome of PT than do the corresponding bias values. We conclude that a laboratory that operates with methods that have internal CVs less than or equal to 33% and biases less than or equal to 20% of the PT criteria will have a greater than 99% chance of passing PT.

The U.S. Institute of Medicine (IOM) much publicized report in “To Err is Human” (2000, National Academy Press) stated that as many as 98 000 hospitalized patients in the U.S. die each year due to preventable medical errors. This revelation about medical error and patient safety focused the public and the medical community's attention on errors in healthcare delivery including laboratory and point-of-care-testing (POCT). Errors introduced anywhere in the POCT process clearly can impact quality and place patient's safety at risk. While POCT performed by or near the patient reduces the potential of some errors, the process presents many challenges to quality with its multiple tests sites, test menus, testing devices and non-laboratory analysts, who often have little understanding of quality testing. Incoherent or no regulations and the rapid availability of test results for immediate clinical intervention can further amplify errors. System planning and management of the entire POCT process are essential to reduce errors and improve quality and patient safety.