Error in laboratory reference limits as shown in a collaborative quality-assurance program.

1986 ◽  
Vol 32 (5) ◽  
pp. 845-849 ◽  
Author(s):  
P J Compton ◽  
M C Stuart ◽  
L Lazarus

Abstract Laboratories participate in collaborative quality-assurance programs to maintain and improve the quality of their diagnostic assays, but little attention has been paid to diagnostic quality in these programs. We used a national quality-assurance program to assess the quality of laboratory reference intervals as exemplified by triiodothyronine, thyroxin, and thyrotropin immunoassays. The limits of the reference intervals used by laboratories bear virtually no relationship to laboratory bias, i.e., whether assays read "high" or "low." Further, correcting assay results from different laboratories for the reference limits used increases rather than decreases interlaboratory scatter. We conclude that the analytical quality of immunoassays now exceeds the quality of the reference limits supplied to clinicians to assist diagnosis, and that nationally or internationally defined reference limits would therefore provide more information at less cost than do individual laboratory reference limits.

Author(s):  
Seema Singh

Quality, as we know so far, was originally developed in the manufacturing industry. In the area of higher education, the adoption of quality control has been superficial and diluted by the exercise of academic . Further, the prevailing culture of universities is often based on individual autonomy, which is zealously guarded. Thus, it is usually difficult to apply the features of quality to higher education considering the fact that quality requires. However, the quality of higher education is very important for its stakeholders. Notably, providers (funding bodies and the community at large), students, staff and employers of graduates are. The most commonly grouped dimensions of quality are product, software and service. In the changing context marked by expansion of higher education and globalization of economic activities, education has become a national concern with an international dimension. To cope with this changing context, countries have been pressurized to ensure and assure quality of higher education at a nationally comparable and internationally acceptable standard. Consequently, many countries initiated “national quality assurance mechanisms” and many more are in the process of evolving a suitable strategy. Most of the quality assurance bodies were established in the nineties and after a few years of practical experience, they are rethinking many issues of quality assurance. At this juncture where countries look for experiences and practices elsewhere, the experience of India has many valuable lessons and this report is an attempt to share those developments..


2012 ◽  
Vol 50 (5) ◽  
Author(s):  
Hallvard Lilleng ◽  
Stein Harald Johnsen ◽  
Tom Wilsgaard ◽  
Svein Ivar Bekkelund

AbstractLaboratory reference intervals are not necessarily reflecting the range in the background population. This study compared creatine kinase (CK) reference intervals calculated from a large sample from a Norwegian population with those elaborated by the Nordic Reference Interval Project (NORIP). It also assessed the pattern of CK-normalization after standardized control analyses.New upper reference limits (URL) CK values were calculated after exclusion of individuals with risk of hyperCKemia and including individuals with incidentally detected hyperCKemia after they had completed a standardized control analysis. After exclusion of 5924 individuals with possible causes of hyperCKemia, CK samples were analyzed in 6904 individuals participating in the 6th survey of The Tromsø Study. URL was defined as the 97.5 percentile.New URL in women was 207 U/L. In men <50 years it was 395 U/L and in men ≥50 years 340 U/L. In individuals with elevated CK, normalization grade after control analysis was inversely correlated to the CK level (p<0.04).URL CK values in women and in men <50 years of age were in accordance with URL CK values given by the NORIP. In men ≥50 years, a higher URL was found and the findings suggest an upward adjustment of URL in this age group.


2016 ◽  
Vol 40 (4) ◽  
Author(s):  
Rainer Haeckel ◽  
Eberhard Gurr ◽  
Torsten Hoff ◽  
on behalf of the working group Guid

AbstractSeveral concepts of analytical bias and remedies to minimize bias have been suggested with the ultimate goal to disregard it. Short-term bias (within one control cycle) should be treated as a random error if it is less than the permissible limits. Long-term bias should be eliminated if it is known or circumvented by estimating intra-laboratory reference limits (RLs). Consequently, analytical uncertainty could be reduced to permissible imprecision. Then, models combining imprecision and bias would become irrelevant, and the numerical value of total analytical error would become identical with imprecision. The purpose of the present report is to simplify quality assurance schemes considerably by disregarding bias either by estimating RLs or by verifying the applied reference limits (checking the transferability) as requested by ISO and CLSI.


2008 ◽  
Vol 35 (5) ◽  
pp. 1807-1815 ◽  
Author(s):  
Jean-Pierre Bissonnette ◽  
Douglas J. Moseley ◽  
David A. Jaffray

2016 ◽  
Vol 58 (3) ◽  
pp. 372-377 ◽  
Author(s):  
Hideyuki Mizuno ◽  
Shigekazu Fukuda ◽  
Akifumi Fukumura ◽  
Yuzuru-Kutsutani Nakamura ◽  
Cao Jianping ◽  
...  

Abstract A dose audit of 16 facilities in 11 countries has been performed within the framework of the Forum for Nuclear Cooperation in Asia (FNCA) quality assurance program. The quality of radiation dosimetry varies because of the large variation in radiation therapy among the participating countries. One of the most important aspects of international multicentre clinical trials is uniformity of absolute dose between centres. The National Institute of Radiological Sciences (NIRS) in Japan has conducted a dose audit of participating countries since 2006 by using radiophotoluminescent glass dosimeters (RGDs). RGDs have been successfully applied to a domestic postal dose audit in Japan. The authors used the same audit system to perform a dose audit of the FNCA countries. The average and standard deviation of the relative deviation between the measured and intended dose among 46 beams was 0.4% and 1.5% (k = 1), respectively. This is an excellent level of uniformity for the multicountry data. However, of the 46 beams measured, a single beam exceeded the permitted tolerance level of ±5%. We investigated the cause for this and solved the problem. This event highlights the importance of external audits in radiation therapy.


2019 ◽  
Vol 290 ◽  
pp. 05004
Author(s):  
Carmen Simion

A successful quality assurance program in any organization needs good measurement systems. The concept of measurement system refers to the manpower, machines, materials, methods and mother nature involved in obtaining measurements. Measurement system analysis (MSA) is a set of procedures which are used to determine the amount of variation due to the measurement system and if the measurement data are valid. Most problematic measurement system issues come when the results of a measurement system are qualitative values such as “pass” or “fail” (attribute data) rather than quantitative values (variable data). Because in industry many measurement systems deal with qualitative data, the assessment of the visual inspection process is a contemporary approach for quality assurance in most manufacturing organizations. The aim of this paper is to apply the MSA attribute study in a local company from the Sibiu region supplying products for automotive industry, to ensure the quality of the visual inspection process for one of their parts, respectively the exterior lighting projectors (Day Running Light, DRLs). The output data were analyzed using Minitab software. The conclusion was that the visual inspection process must be improved by appraisers training and developing panel with samples for the most common defect types of DRLs.


1984 ◽  
Vol 3 (6) ◽  
pp. 377-380
Author(s):  
R. S. DeWoskin ◽  
B. M. Sadler

Quality does not mean compliance with a checklist of standards but rather “fitness for use.” Compliance with a checklist of standards will only assure quality if the standards specifically address the intended use of the final results. In the design of a quality assurance program, the emphasis is upon quality controls and monitoring schedules for those aspects of the study that significantly alter the variability of the final results and alter the variability to the extent that the final results are no longer useful. Therefore, the principal researcher in conjunction with the quality assurance staff contribute to the quality of a study by applying combined expertise in the design of specific reference standards that both address the fitness for use criterion and the more comprehensive government standards.


1990 ◽  
Vol 20 (1) ◽  
pp. 75-85
Author(s):  
William G. Webster

Quality assurance programs have become an integral part of the health delivery processions during the past quarter century. They generally focus on the appropriateness and adequacy of services provided, with the objective of identifying and correcting deficiencies of service. Appropriateness and adequacy are assessed by the degree of adherence of practices to explicit standards, and these in turn relate to criteria of structure, process, outcome and efficiency. The key concepts and methodologies of quality assurance programs are reviewed, and it is suggested that they can be readily applied to Canadian universities. A quality assurance program within a university could be a powerful administrative and curricular development tool that would serve to define and enhance the quality of educational experiences of students.


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