Establishing and evaluating QC acceptability criteria.
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Clinical Laboratory Techniques↗
Biomedical subjects
P L Barry
Publications and source records attributed to P L Barry.
Allowable imprecision for laboratory tests based on clinical and analytical test outcome criteria.
The allowable imprecision for laboratory tests has been estimated from criteria based on clinical and analytical test outcome. The analytical outcome criteria studied are the Clinical Laboratory Improvement Amendments (CLIA) criteria for proficiency testing. The clinical outcome criteria are estimates of medically significant changes in test results taken from a study in the literature. The estimates of allowable imprecision were obtained from quality-planning models that relate test outcome criteria to the allowable amount of imprecision and inaccuracy and to the quality control that is necessary to assure achievement of the desired outcome criteria in routine operation. These operating specifications for imprecision are consistently more demanding (require lower CVs) than the medically useful CVs originally recommended in the literature because the latter do not properly consider within-subject biological variation. In comparing estimates of allowable imprecision, the CLIA outcome criteria are more demanding than the clinical outcome criteria for aspartate aminotransferase (asymptomatic patients), cholesterol, creatinine (asymptomatic patients), glucose, thyroxine, total protein, urea nitrogen, hematocrit, and prothrombin time. The clinical outcome criteria are more demanding for bilirubin (acute illness), iron, potassium, urea nitrogen (acute illness), and leukocyte count. The estimates of allowable imprecision from analytical and clinical outcome criteria overlap for aspartate aminotransferase (acute illness), bilirubin (asymptomatic patients), calcium, creatinine (acute illness), sodium, triglyceride, and hemoglobin.
Calcium↗
European specifications for imprecision and inaccuracy compared with operating specifications that assure the quality required by US CLIA proficiency-testing criteria.
Proposed and interim European quality specifications for imprecision and inaccuracy have been compared with the US CLIA total error criteria for proficiency testing (PT). To assess the relative demands of separate imprecision and inaccuracy specifications vs total error criteria, we derived the imprecision and inaccuracy that would be allowable if a testing process were to provide 90% assurance of achieving the analytical quality required by CLIA PT criteria. Charts of operating specifications (OPSpecs charts) were prepared for commonly used single-rule and multi-rule quality control procedures with 2 and 4 control measurements per run. Of the 23 tests studied, the proposed European specifications for imprecision and inaccuracy were more demanding than the CLIA requirements for 12 tests (albumin, alkaline phosphatase, amylase, calcium, chloride, creatinine, lactate dehydrogenase, lithium, magnesium, total protein, sodium, and thyroxine). The CLIA total error criteria were more demanding than the proposed European specifications for nine tests (alanine aminotransferase, aspartate aminotransferase, total bilirubin, cholesterol, creatine kinase, iron, triglycerides, uric acid, and urea nitrogen). Two tests (glucose, potassium) showed different requirements at different decision levels. Manufacturers and laboratory analysts need to compare these different quality specifications on a test-by-test basis to guide the development, selection, evaluation, and control of laboratory measurement procedures.
Blood Chemical Analysis↗
Selection of medically useful quality-control procedures for individual tests done in a multitest analytical system.
Quality-control (QC) procedures (i.e., decision rules used, numbers of control measurements collected per run) have been selected for individual tests of a multitest analyzer, to see that clinical or "medical usefulness" requirements for quality are met. The approach for designing appropriate QC procedures includes the following steps: (a) defining requirements for quality in the form of the "total allowable analytical error" for each test, (b) determining the imprecision of each measurement procedure, (c) calculating the medically important systematic and random errors for each test, and (d) assessing the probabilities for error detection and false rejection for candidate control procedures. In applying this approach to the Hitachi 737 analyzer, a design objective of 90% (or greater) detection of systematic errors was met for most tests (sodium, potassium, glucose, urea nitrogen, creatinine, phosphorus, uric acid, cholesterol, total protein, total bilirubin, gamma-glutamyltransferase, alkaline phosphatase, aspartate aminotransferase, lactate dehydrogenase) by use of 3.5s control limits with two control measurements per run (N). For the remaining tests (albumin, chloride, total CO2, calcium), requirements for QC procedures were more stringent, and 2.5s limits (with N = 2) were selected.
Autoanalysis↗
Clinical laboratory and nursing personnel: collaboration in improving patient care.
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Critical Care↗
Implementation of a multirule, multistage quality control program in a clinical laboratory computer system.
We developed a computer subsystem that permits users to implement multirule, multistage quality control procedures. The subsystem runs as a task in the RelationaLABCOM information system and permits the collection of data from on-line instruments, as well as through manual (keyboard) entry. The choices of control rules and their combinations are at the discretion of each laboratory section, with the system automatically administering the chosen protocols for all the technologists working with the computer. Retrospective data analysis and statistics are available for review by laboratory personnel. The subsystem provides a significant improvement in the availability of real-time quality control at the bench.
Clinical Laboratory Information Systems↗
Workshops for teaching quality control to laboratory personnel: objectives and guidelines.
The educational aspects are crucial for a successful implementation of new control procedures in the clinical laboratory. The initial effort can take the form of workshops directed to laboratory directors and supervisors on one hand, and to laboratory analysts on the other. The present paper gives an outline of objectives and guidelines for teaching quality control to these two groups of laboratory personnel.
Allied Health Personnel↗
A multi-rule Shewhart chart for quality control in clinical chemistry.
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Chemistry, Clinical↗
Implementing total quality management (TQM) in health-care laboratories.
Health-care organizations are beginning to apply the principles of total quality management (TQM). Implementing TQM in a health-care laboratory requires incorporating quality improvement (QI) and quality planning (QP) with quality laboratory practices (QLP), quality control (QC), and quality assurance (QA) to provide a complete quality management system. QI and QP can be initiated by developing a strategic plan as a pilot QI project. QI project teams are then introduced to accomplish the highest priority goals. This implementation approach improves strategic planning by using group problem-solving tools and techniques, such as process flow charts, brainstorming, nominal group, fishbone diagrams, consensus decision making, and Pareto analysis. The approach also improves the success of project teams by providing a clear management agenda and a commitment to project-by-project QI.
Humans↗