POCT Analysts' Perspective: Practices and Wants for Improvement.

BACKGROUND: Point-of-care testing (POCT) continues to expand worldwide. Concerns remain about result quality despite guidelines and standards that specify testing practices. To better understand POCT testing worldwide, we polled analysts to obtain their views on actual practices and needs for improvement. METHODS: An online questionnaire was constructed on SurveyMonkey, a commercially available website for conducting such surveys. POCT analysts were sought worldwide from a pool of healthcare providers subscribed to a westgard.com newsletter or visitors to westgard.com and/or LinkedIn to one of the authors. RESULTS: Seventy-three percent of testing occurred in hospitals with 64% conducted in specialty settings. Regulatory mandates were followed by 88%. For most, less than 100 tests were performed per day fewer less than 25 devices. Nurses top the list of analysts. All but 5% of analysts received some form of training primarily from manufacturers. Eighty-seven percent verified devices/methods prior to implementation. Five percent do not perform daily QC; all analyzed external QC at least once per month. When QC limits exceed acceptable limits, 92% stop testing. Expired materials were used by 5%. The majority collected data for quality improvements. Eleven percent thought their organization's POCT is acceptable. The majority of respondents believe improvements need to be made in POCT. CONCLUSIONS: Analysts' POCT practices have and are improving to contribute positively to patients' healthcare and safety. Analysts do recognize problems and their wants/needs provide important information to improve their practices. Most participants desire more in-house and/or manufacturer training, explicit directions from manufacturers, manufacturer built-in quality and function checks, and oversight.

Satisfying regulatory and accreditation requirements for quality control.

The Clinical Laboratory Improvement Amendments of 1988 (CLIA) requires all US clinical laboratories that test "materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease..." to be regulated. The CLIA mandates are site neutral; based on test complexity; and focus on the three phases of the testing process (preanalytical, analytical, and postanalytical). Many testing sites choose to meet the CLIA requirements by following the testing standards of a professional accreditation organization deemed by the Centers for Medicare and Medicaid Services. The three principal organizations are The Joint Commission, the College of American Pathologists, and COLA.

Plan for quality to improve patient safety at the point of care.

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.

Collective opinion paper on findings of the 2010 convocation of experts on laboratory quality.

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.

Regulatory compliance for point-of-care testing: 2009 United States perspective.

All clinical laboratory testing in the United States is regulated by the Clinical Laboratory Improvement Amendments of 1988 (CLIA'88 or CLIA) and overseen by the Centers for Medicare and Medicaid Services. CLIA profoundly changed the prevailing United States regulatory philosophy by imposing uniform requirements for all clinical laboratory testing regardless of where tests are performed. In the hospital, regulatory compliance is usually ensured by regular inspections of the laboratory by either the Joint Commission or by the College of American Pathologists. These organizations may include requirements beyond the minimum standard mandated by CLIA. This article reviews the status of regulatory compliance of point-of-care testing from a perspective of the current regulations in effect in the United States in 2009.

Point-of-care testing, medical error, and patient safety: a 2007 assessment.

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.

Has compliance with CLIA requirements really improved quality in US clinical laboratories?

BACKGROUND: The Clinical Laboratory Improvement Amendments of 1988 (CLIA'88) mandate universal requirements for all U.S. clinical laboratory-testing sites. The intent of CLIA'88 is to ensure quality testing through a combination of minimum quality practices that incorporate total quality management concepts. These regulations do not contain established, objective indicators or measures to assess quality. However, there is an implicit assumption that compliance with traditionally accepted good laboratory practices--following manufacturers' directions, routinely analysing quality control materials, applying quality assurance principles, employing and assessing competent testing personnel, and participating in external quality assessment or proficiency testing (PT)--will result in improved test quality. METHODS: The CLIA'88 regulations do include PT performance standards, which intentionally or unintentionally, define intra-laboratory performance. Passing PT has become a prime motivation for improving laboratory performance; it can also be used as an objective indicator to assess whether compliance to CLIA has improved intra-laboratory quality. RESULTS: Data from 1994 through 2002 indicate that the percentage of laboratories passing PT has increased. In addition to PT performance, subjective indicators of improved quality--frequency of inspection deficiencies, the number of government sanctions for non-compliance, and customer satisfaction--were evaluated. CONCLUSIONS: The results from these subjective indicators are more difficult to interpret but also seem to show improved quality in US clinical laboratories eleven years post-CLIA'88.