Proficiency testing studies

General Lab. and Pharma. Lab. participate In proficiency-testing studies and market surveillance studies organised by European Department for Quality of... 

The Central Chemical Laboratory (CLCh) is the primary analytical facility of the Polish Geological Institute (PIG) and carries out practically all the chemical analysis at PIG. CLCh took part in the INCO-COPERNICUS Project Development of Analytical Procedures to Guarantee Quality Assurance in International Environmental Monitoring . CLCh participated in numerous international inter-laboratory comparisons as well as organized various inter-laboratory comparatives and proficiency testing studies for laboratories of Provincial Environment Protection Inspectorates. In March 2000, CLCh was granted the Certificate of Testing Laboratory Accreditation, with respect to physical and chemical analyses of water. 

The magnitude of these errors can be analyzed in single laboratories (run bias and repeatability error), in inter-laboratory validation studies (laboratory bias) and in proficiency tests (method bias). Expressed in standard deviations relative to that of... 

Proficiency testing is a special type of laboratory performance studies defined as study of laboratory performance by means of ongoing interlaboratory test comparisons (ISO Guide 33 [1989] ISO/REMCO N 280 [1993] IUPAC [1993] Prichard et al. [2001]). Proficiency testing is an essential part of external quality assessment schemes and performance checks. 

Take part in External Quality Assessment, formally through Proficiency Testing schemes and informally by taking part in intercomparison studies. 

To understand the difference between proficiency testing schemes and collaborative studies. 

The previous chapters of this book have discussed the many activities which laboratories undertake to help ensure the quality of the analytical results that are produced. There are many aspects of quality assurance and quality control that analysts carry out on a day-to-day basis to help them produce reliable results. Control charts are used to monitor method performance and identify when problems have arisen, and Certified Reference Materials are used to evaluate any bias in the results produced. These activities are sometimes referred to as internal quality control (IQC). In addition to all of these activities, it is extremely useful for laboratories to obtain an independent check of their performance and to be able to compare their performance with that of other laboratories carrying out similar types of analyses. This is achieved by taking part in interlaboratory studies. There are two main types of interlaboratory studies, namely proficiency testing (PT) schemes and collaborative studies (also known as collaborative trials). 

What do you think is the main difference between a proficiency testing scheme and a collaborative study ... 

A proficiency testing scheme tests the performance of the participating laboratories whereas a collaborative study is used to test the performance of a particular method. 

If data from a collaborative study are not available to estimate the reproducibility of a method, a general model such as the Horwitz function can be used. The Horwitz function is described in Chapter 4, Sections 4.4 and 4.6.2. It can be used to predict the value of or based on the concentration of the analyte in the proficiency test material. The disadvantage of this approach is that the chosen model may not accurately represent the true reproducibility of the method. 

En numbers are used when the assigned value has been produced by a reference laboratory, which has provided an estimate of the expanded uncertainty. This scoring method also requires a valid estimate of the expanded uncertainty for each participant s result. A score of En < 1 is considered satisfactory. The acceptability criterion is different from that used for z-, z - or zeta-scores as En numbers are calculated using expanded uncertainties. However, the En number is equal to zeta/2 if a coverage factor of 2 is used to calculate the expanded uncertainties (see Chapter 6, Section 6.3.6). En numbers are not normally used by proficiency testing scheme providers but are often used in calibration studies. 

This chapter has considered two of the types of interlaboratory comparison exercise in which your laboratory may participate. It is important to remember that proficiency testing schemes and collaborative studies have different aims. The former is a test of the performance of the laboratory, whereas the latter is used to evaluate the performance of a particular analytical method. Laboratories should participate in proficiency testing schemes (where an appropriate scheme is available) as this provides an independent check of the laboratory s performance. This chapter has described the key features of proficiency testing schemes and explained how the results from participation in a scheme should be interpreted. 

ISO, IUPAC and AOAC INTERNATIONAL have co-operated to produce agreed protocols on the Design, Conduct and Interpretation of Collaborative Studies 14 and on the Proficiency Testing of [Chemical] Analytical Laboratories .11 The Working Group that produced these protocols has prepared a further protocol on the internal quality control of data produced in analytical laboratories. The document was finalised in 1994 and published in 1995 as the Harmonised Guidelines For Internal Quality Control In Analytical Chemistry Laboratories .12 The use of the procedures outlined in the Protocol should aid compliance with the accreditation requirements specified above. 

TABLE 9 Differences between Method Performance Studies and Proficiency-Testing Schemes... 

Any or all of these conditions can be varied. To provide some guidance, intralaboratory reproducibility is used to express changes only within a laboratory, and interlaboratory reproducibility" is used to refer to the changes that occur between laboratories, for example in proficiency testing, interlaboratory method validation studies, and the like. Interlaboratory reproducibility is usually two to three times the repeatability. 

If data are normally distributed, the mean and standard deviation are the best description possible of the data. Modern analytical chemistry is often automated to the extent that data are not individually scrutinized, and parameters of the data are simply calculated with a hope that the assumption of normality is valid. Unfortunately, the odd bad apple, or outlier, can spoil the calculations. Data, even without errors, may be more or less normal but with more extreme values than would be expected. These are known has heavy-tailed distributions, and the values at the extremes are called outliers. In interlaboratory studies designed to assess proficiency, the data often have outliers, which cannot be rejected out of hand. It would be a misrepresentation for a proficiency testing body to announce that all its laboratories give results within 2 standard deviations (except the ones that were excluded from the calculations). 

The test material is chosen to fulfill the aims of the study. In a proficiency testing scheme or a method validation study, the test material is usually as near as possible to typical field samples. There is no advantage in competently analyzing an artificial sample if the same laboratory has difficulty with real samples. The organizing laboratory must know the composition of the test material, and must be sure that the analyte for which a quantity is to be measured is present in about the desired amount. For pure materials this is not a problem, but for natural test materials or complex matrix materials, the organizing laboratory may have to do some analyses before the samples can be sent out to the participants. If the value of the measurand is to be established by an independent laboratory before the study, then the identity requirement is also fulfilled when the measurand is stated. 

Maier, E A., Quevauviller, Ph, and Griepink, (1993), Interlaboratory studies as a tool for many purposes proficiency testing, learning exercises, quality control and certification of matrix materials. Analytica Chimica Acta, 283 (1), 590-99. 

Residue-testing laboratories might also need to review their sample preparation processes and consider modifying or eliminating tissue homogenization prior to residue extraction. Suppliers of proficiency-testing services should also question whether certain drugs are appropriate to include in such studies. For example, liver spiked with sulfaquinoxaline, sulfadiazine, or sulfamerazine is not suitable for preparation of spiked interlaboratory check samples or reference materials. 

Evaluations of various soil and sediment samplers have been reported [56, 57]. The sediment shovel proved highly practical, but was limited because small particles tend to be lost when the shovel is lifted [56]. A cryogenic sediment sampler was less convenient to use, but allowed the collection of almost undisturbed samples. Houba described a different device for the automatic subsampling of soil, sediment and plant material for proficiency testing [57]. In another study, Thoms showed that freeze-sampling collects representative sediment samples, whereas grab-sampling introduces a bias into the textural composition of the 120 mesh fraction, due to washout and elutriation of the finer fractions [58]. 

LEDOUX M and hall s, Proficiency testing of eight French laboratories in using the AOAC mouse bioassay for paralytic shellfish poisoning interlaboratory collaborative study , J. AOAC Int 2000 83 305-10. 

Quality control of laboratories depends on the availability of CRMs, round-robin studies, intercomparisons and proficiency tests between methods and between laboratories. Of special importance is a full knowledge of the complex analytical process and the painstaking pursuit of the true value by defining all sources of errors and the application of an adequate error source budget. The application of Poisson and Bayesian statistics could have some advantage. 

However the chemical community has not been dormant in the period since the Convention of the Meter came into being. A vast range of analytical methods has been developed with ever increasing sensitivity and selectivity. Comparability of measurement results has been achieved in many sectors by the use of collabora-tively studied methods, reference materials, check samples and proficiency testing schemes. It is only recently that steps have been taken to develop traceability to international standards. In developing this traceability much can be learnt from the way traceability has developed for physical measurements. 

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