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PubMed1982

Basic statistics for quality control in the clinical laboratory.

A systematic approach toward selection and evaluation of laboratory methods should improve the quality of the analytical service. However, any testing approach only assesses whether the analytical method can achieve the desired level of performance under the test conditions. It does not assure that the performance is actually achieved under the conditions of each routine analytical run. The quality of the routine analysis must be monitored by suitable quality control procedures. Unfortunately, the present practice of quality control achieves an arbitrary and usually unknown level of quality. Achieving a known level of quality requires that one understand the performance characteristics of the quality control procedures themselves. Achieving a specified level of quality requires that one design the quality control system to achieve a stated error specification. This can be accomplished by careful choice of control procedures in order to have the desired capability for detecting analytical errors which would invalidate the medical usefulness of the test results. A high-caliber quality control system will be the result of a logical sequence of the objective evaluation and selection of an optimal analytical method followed by regular rigorous statistical monitoring of each analytical method.

Analysis of Variance↗
PubMed2006

A complex of Yos9p and the HRD ligase integrates endoplasmic reticulum quality control into the degradation machinery.

A quality-control system surveys the lumen of the endoplasmic reticulum for terminally misfolded proteins. Polypeptides singled out by this system are ultimately degraded by the cytosolic ubiquitin-proteasome pathway. Key components of both the endoplasmic reticulum quality-control system and the degradation machinery have been identified, but a connection between the two systems has remained elusive. Here, we report an association between the endoplasmic reticulum quality-control lectin Yos9p and Hrd3p, a component of the ubiquitin-proteasome system that links these pathways. We identify designated regions in the luminal domain of Hrd3p that interact with Yos9p and the ubiquitin ligase Hrd1p. Binding of misfolded proteins occurs through Hrd3p, suggesting that Hrd3p recognises proteins that deviate from their native conformation, whereas Yos9p ensures that only terminally misfolded polypeptides are degraded.

Blotting, Western↗
PubMed1976

The preparation of simulated water samples for the purpose of bacteriological quality control.

As part of the bacteriological quality control programme of the Public Health Laboratory Service, we were asked to investigate the possibility of providing simulated water samples for distribution to the laboratories. For this purpose it was necessary to find some means whereby suspensions of coliform organisms and Escherichia coli could be kept relatively stable in number at room temperature for a period of 7-10 days. This, it was finally found, was best achieved by adding selected strains of the organisms to improved formate lactose glutamate medium (Gray, 1964) without the lactose but with added boric acid to a final concentration of 1-8%. The procedures adopted in the successful quality control programme are described.

Boric Acids↗
PubMed1976

[Laboratory standardization and quality control in anticoagulant therapy].

Standardisation and quality control are now available for the laboratory tests which are needed to control the blood levels of anticoagulants. The most important cause for variation in results between different laboratories is the use of different types of thromboplastin. The British standards are based on the use of a national reagent with a national system of reporting supported by quality control with lyophilised plasma and thromboplastin preparations. It offers a model which has been adopted at Tygerberg Hospital, and could be used to standardise anticoagulant therapy in this country. Human brain thromboplastin is preferred to the commercially available rabbit preparations. For the first time, as far as we know, a phenol-saline extract of baboon brain thromboplastin was examined. Preliminary results indicate that it compares well with human brain extracts.

Animals↗
PubMed1974

Observer variation and quality control of cytodiagnosis.

The aim of quality control of a laboratory investigation is to ensure that similar results are obtained on the same material at different centres. To investigate its practicability in cytodiagnosis, the same cytological material was examined independently at six centres. Each centre supplied material from 20 cases, providing a total of 120 cases, ie, 100 cases excluding the donor centre's own material. The degree of agreement between the centres was studied using (a) the standard National Health Service cytology report terminology, (b) the centre's own terminology, and (c) the recommended recall time. The results revealed close agreement between five out of six centres in the reports obtained in relation to dysplasia and malignancy, namely, less than 3% false negative results and not more than 1.7% false positive results. The recommended recall time provided a similar order of agreement after discrepancies due to the management of inflammatory conditions had been eliminated. There was marked disagreement in the diagnosis of both presence and type of infection. The results indicate that improvement in the quality of cytological material would increase the consistency of cytodiagnosis. Cytodiagnosis itself, being an expression of opinion, does not appear to be an appropriate field for quality control.

Candida albicans↗
PubMed2004

Evaluation of quality-control criteria for microarray gene expression analysis.

BACKGROUND: Development of quality-control criteria to ensure reproducibility of microarray results for potential clinical application is still in its infancy. METHODS: In the present studies we developed quality-control criteria and evaluated their effect in microarray data analysis using total RNA from cell lines, frozen tumors, and a commercially available reference RNA. Quality-control criteria such as A(260)/A(280) ratios, percentage of rRNA, and median size of cDNA and cRNA synthesis products were evaluated for robustness in microarray analysis. Furthermore, precision studies using a reference material were performed on the Affymetrix HG-U133A high-density oligonucleotide microarrays. The same reference RNA sample was examined in 16 different chips run on 2 different days in the four different modules of the Affymetrix fluidics workstation. Fresh and frozen fragmented cRNAs were also compared. An ANOVA model was fit to identify the main sources of variation. RESULTS: Good-quality samples showed >30% rRNA in the electropherograms and cDNA and cRNA synthesis products with median sizes of 2.0 and 3.0 kb, respectively. Precision studies showed that the main source of variation was the day-to-day variability, minimally affecting hybridization exogenous control genes. Altogether, the results showed that the Affymetrix Genechip system is highly reproducible when RNA that meet the quality-control criteria are used (overall P >0.01). CONCLUSIONS: These results confirm the need to establish defined quality-control criteria for sample quality to distinguish between analytical and biological variability.

Analysis of Variance↗
PubMed2005

A dual modality approach to quantitative quality control in emission tomography.

Routine quality control (QC) and optimization of image quality of reconstructed images in single photon emission computed tomography (SPECT) and positron emission tomography (PET) remains a relatively qualitative exercise. With the advent of combined SPECT/CT and PET/CT devices, and accurate post hoc co-registration algorithms, the potential exists to utilize high resolution structural information for QC evaluation in addition to their use for anatomical correlation in clinical studies. The aim of this work was to explore, in principle, the uses of x-ray CT data of QC phantoms used in SPECT and PET to develop more objective assessments of performance of the emission tomographic (ET) devices and reconstructed data. A CT reconstruction of a novel ET QC phantom was segmented into the various compartments it contained. Using software, the voxel values in the different compartments were then altered to correspond to the concentration of the radioactivity in the actual scan of the same phantom on the SPECT system. This produces a high resolution version of a 'perfect' ET scan. Image co-registration techniques were then used to spatially align the synthetic high resolution SPECT scan to the measured SPECT scan. Various parameters can then be objectively derived from the registered data, for example, image contrast, spatial resolution, spatial non-uniformity, etc. In this study, we have used this approach to estimate spatial resolution (full width at half maximum, FWHM) and recovered contrast in reconstructed images of a SPECT phantom. Two independent methods were used to measure spatial resolution, obtaining excellent agreement. In conclusion, the ability to produce high resolution synthetic phantoms in emission tomography QC affords an objective approach to assessing system performance and optimizing protocols which is readily automated and quantifiable.

Algorithms↗
PubMed2003

Role of calnexin in the glycan-independent quality control of proteolipid protein.

The endoplasmic (ER) quality control apparatus ensures that misfolded or unassembled proteins are not deployed within the cell, but are retained in the ER and degraded. A glycoprotein-specific system involving the ER lectins calnexin and calreticulin is well documented, but very little is known about mechanisms that may operate for non-glycosylated proteins. We have used a folding mutant of a non- glycosylated membrane protein, proteolipid protein (PLP), to examine the quality control of this class of polypeptide. We find that calnexin associates with newly synthesized PLP molecules, binding stably to misfolded PLP. Calnexin also binds stably to an isolated transmembrane domain of PLP, suggesting that this chaperone is able to monitor the folding and assembly of domains within the ER membrane. Notably, this glycan-independent interaction with calnexin significantly retards the degradation of misfolded PLP. We propose that calnexin contributes to the quality control of non-glycosylated polytopic membrane proteins by binding to misfolded or unassembled transmembrane domains, and discuss our findings in relation to the role of calnexin in the degradation of misfolded proteins.

Animals↗
PubMed2004

Developing a quality control protocol for diffusion imaging on a clinical MRI system.

This work describes the development of a quality control protocol, which can be implemented to assess the accuracy, precision and reproducibility of the apparent diffusion coefficient (ADC) measurement on a clinical magnetic resonance imaging (MRI) system. The precision and accuracy of the ADC measurement are analysed with regard to MRI system noise, signal reproducibility and differences between nominal and effective b values. Two aqueous test-solutions of CuSO4 and sucrose are prepared for the quality control protocol. ADC measurement with the CuSO4 solution is more sensitive to differences between nominal and effective b values, on account of the solution's high ADC. ADC measurement with the sucrose solution is more sensitive to signal reproducibility due to the solution's low baseline signal intensity. The ADC of the test-solutions is measured on an MRI system at our centre with a sequence used for clinical studies using diffusion imaging. Two parameters, Q and R, are defined for the analysis of the quality control ADC values. The Q parameter is the ratio of the standard deviation of the quality control mean ADC values over time to the optimal standard deviation, as derived from the effect of thermal noise on the ADC measurement uncertainty. Analysis with the Q parameter indicates that signal reproducibility errors contribute to ADC variations on our MRI system when imaging with high b values (b > 500 mm s(-2)), whereas differences between nominal and effective b values have a greater impact on the ADC measurement when imaging with low b values (b < 500 mm s(-2)). The R parameter is defined as the ratio of the directional variation of the ADC quality control values to the uncertainty of the ADC measurement. Analysis with the R parameter shows that the effect of directional variation of the ADC measurement on our MRI system is more pronounced when imaging with low b values. The quality control protocol identified a systematic error, which introduced a small system-induced anisotropy in the ADC measurement. This error is currently taken into account in the analysis of clinical studies employing the diffusion imaging sequence used in this quality control protocol.

Anisotropy↗
PubMed1990

Quality control practices in centralized tumor registries in North America.

A survey of quality control practices was mailed to 73 central registries in the U.S. and Canada. The response rate was 88%, with respondents representing a wide range of registry characteristics and reporting strategies. While registries expressed different priorities in data use, 80% of respondents felt quality control data were important in the identification of problems. The most common method of quality control was acceptance sampling (used by 97% of respondents), and took the form of visual review, recoding and edit checking. Computer-based edit checks were almost universally used (95%). Process control methods of any sort were used by only 22% of respondents with less than 4% of registries reporting formal quantitative criteria. Sixty-one percent of respondents reported conducting one or more designed studies (e.g. reabstracting or casefinding studies) but only 20% of those made the results public. Greater emphasis should be placed on development of quantitative process controls, experimental design of quality control studies, and formal analyses and reporting of study results.

Canada↗
PubMed2003

Retrospective exposure assessment and quality control in an international multi-centre case-control study.

The paper presents the exposure assessment method and quality control procedure used in an international, multi-centre case-control study within a joint Nordic and Italian cohort. This study was conducted to evaluate whether occupational exposure to carcinogens influenced the predictivity of high frequency of chromosomal aberrations (CA) in peripheral lymphocytes for increased cancer risk. Occupational hygienists assessed exposures in each participating country: Denmark, Finland, Italy, Norway and Sweden. The exposure status to a carcinogen or a clastogen was coded in the cohort according to the original CA studies at the time of CA testing, but not for the whole work life. An independent occupational hygienist coordinated harmonization of the assessment criteria and the quality control procedure. The reliability of the exposure assessments was calculated as deviation from the majority of the assessors, as Cohen's kappa and as overall proportion of the agreements. The reassessment of the exposures changed the exposure statuses significantly, when compared with the original cohort. Harmonization of the exposure criteria increased the conformity of the assessments. The prevalence of exposure was higher among the original assessors (the assessor from the same country as the subject) than the average prevalence assessed by the other four in the quality control round. The original assessors classified more job situations as exposed than the others. Several reasons for this are plausible: real country-specific differences, differences in information available to the home assessor and the others and misunderstandings or difficulties in translation of information. To ensure the consistency of exposure assessments in international retrospective case-control studies it is important to have a well-planned study protocol. Due to country-specific environments a hygienist from each participating country is necessary. A quality control study is recommended, to be performed as described, combined with round-table meetings to minimize information bias between the assessors.

Carcinogens↗
PubMed1996

Computerized approach to active and objective quality control of patient care.

The paper describes a quality control program based on the principles of clinical methodology and indicators defined by physicians and hospital administrators according to general as well as local needs. The program is supported by a knowledge-based system which can be used in two ways: with on-line helps and hints to ensure effective and efficient medical decisions on a simulated patient for training purposes; and without facilities supporting the user to be used on an on-line setting for performance evaluation. The quality control program includes the evaluation of effectiveness and efficiency of patient care with respect to the overall process, single hypotheses and individual decisions: the evaluation regards the number and reliability of activated hypotheses, costs, time spent, number and appropriateness of investigations. The overall process is recursive, in that the results of each cycle are used by physicians to define new goals and indicants for the next cycle; quality control is active because physicians under evaluation are directly involved in the definition of goals and indicants and in the evaluation of results; evaluation is objective because indicants are predefined, and evaluation criteria are transparent.

Artificial Intelligence↗
PubMed1988

Experiences with a statistical quality control system (QCS) for coagulation diagnostics parameters.

With the Quality-Control-Service (QCS) for blood coagulation a system for the statistical quality control of blood coagulation methods is presented. The system is based on the universal control plasma PreciClot which contains target values in the normal and abnormal range. As the control plasma is used daily from the participants for quality control exercises and datas are statistically analyzed each month this programme of quality assessment can be compared with a monthly ring trial. For the methods prothrombin time (PT/Quick), activated partial prothrombin time (APTT), fibrinogen assay (Fibrinogen) and thrombin time (Thrombin) datas of a survey period (January-December 1985) with 75 labs were evaluated. Calculated results for the methods are given and accuracy and precision of the methods are compared with the results of former ring trials. Based on the results the interlaboratory reliability of the methods is discussed and the advantages of QCS for blood Coagulation for a better information about quality of coagulation tests are presented.

Blood Coagulation Tests↗
PubMed1997

[Quality assurance for the measured values and quality control].

It is essential for us to build a liable quality control system in order to report excellent results assured of quality. For the purpose, not only the execution of quality control on laboratory side but also the recognition of quality control on clinical side are important. And more important matter is to record the error of measured values.

Laboratories↗
PubMed2005

Vibrational spectroscopic studies to acquire a quality control method of Eucalyptus essential oils.

This article presents a novel and original approach to analyze in situ the main components of Eucalyptus oil by means of Raman spectroscopy. The obtained two-dimensional Raman maps demonstrate a unique possibility to study the essential oil distribution in the intact plant tissue. Additionally, Fourier Transform (FT)-Raman and attenuated total reflection (ATR)-IR spectra of essential oils isolated from several Eucalyptus species by hydrodistillation are presented. Density Functional Theory (DFT) calculations were performed in order to interpret the spectra of the essential oils of the Eucalyptus species. It is shown that the main components of the essential oils can be recognized by both vibrational spectroscopic techniques using the spectral information of the pure terpenoids. Spectroscopic analysis is based on the key bands of the individual volatile substances and therefore allows one to discriminate different essential oil profiles of several Eucalyptus species. It has been found that the presented spectroscopic data correlate very well with those obtained by gas chromatography (GC) analysis. All these investigations are helpful tools to generate a fast and easy method to control the quality of the essential oils with vibrational spectroscopic techniques in combination with DFT calculations.

Eucalyptus↗
PubMed2006

Development of high-performance liquid chromatographic fingerprint for the quality control of Rheum tanguticum Maxim. ex Balf.

A novel, accurate and valid fingerprint method was developed by using high-performance liquid chromatography-photodiode array detection (HPLC-DAD) to control the quality of Rheum tanguticum Maxim. ex Balf. By comprehensively comparing chromatograms of all samples, our result revealed that the chromatographic fingerprint we developed combining similarity evaluation could efficiently identify and distinguish raw materials of R. tanguticum from different sources. Besides, 21 characteristic peaks in chromatogram of R. tanguticum were unambiguously confirmed by comparison of reference compounds based on their retention time (t(R)) and UV spectra.

Chromatography, High Pressure Liquid↗
PubMed2006

Comparison of the recovery spread in analytical development and routine quality control--based on the ICH quality guideline Q2B.

In the present study, a simulation was performed for the ICH Q2B guideline for assessing the accuracy. By means of an experimental data set a permutation has been performed to investigate in which interval experimental mean recovery can be expected to scatter just by random effects. A good agreement has been found between the experimental intervals obtained by means of a permutation and the statistically derived confidence intervals. These findings could be confirmed with additionally generated virtual data sets with a true mean of 100% and a true standard deviation of 0.7%.

Chemistry Techniques, Analytical↗
PubMed1999

Collaborative study to improve the quality control of rare earth element determinations in environmental matrices.

In order to control the quality of rare earth determinations in environmental matrices, the Standards, Measurements and Testing Programme (formerly Community Bureau of Reference, BCR) of the European Commission has started a project, the final aim of which is to certify four types of matrices (tuna muscle, mussel tissue, aquatic plant and estuarine sediment) for their contents of a range of rare earth elements (Sc, Y and the lanthanides: La, Ce, Pr, Nd, Sm, Eu, Gd, Tb, Dy, Ho, Er, Tm, Yb and Lu). The elements U and Th were added to the study. The first part of this project consisted of an interlaboratory study which aimed to test the feasibility of preparation of environmental reference materials and to detect and remove most of the pitfalls observed in rare earth determinations. This paper presents the preparation of the four matrices for the intercomparison study and for the candidate reference material. The main results are presented of the interlaboratory study that was carried out prior to the certification campaign. This collaborative trial is the first attempt ever carried out at this scale to evaluate the state-of-the-art of rare earth determinations in the environment. Its impact on the improvement of chemical measurements will have positive effects on the comparability of data necessary for environmental monitoring.

Chemistry Techniques, Analytical↗