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PubMedDate not supplied

Quality control in a medical information system.

Quality assurance techniques provide an opportunity to identify sources of error and to provide the feedback necessary to prevent their repetition. The authors outline an effort to define the steps required for effective quality management procedures in a computerized medical information system (MIS). The computerized management of medical information can be used not only to enhance current quality management activities but also to extend the realm of quality assurance to areas that have heretofore resisted management. Quality-management techniques have the potential for measuring and improving medical decision making processes central to patient care.

Abstracting and Indexing↗

PubMed2004

Capillary electrophoresis of proteins in a quality control environment.

A method for determining the purity of recombinant carboxypeptidase B utilizing CE-SDS has been developed and validated for use in a manufacturing quality control laboratory. The method was optimized, prior to validation, to allow for the lowest limit of quantitation. The method was validated with the typical ICHQ2A parameters, including accuracy, linearity, LOQ, precision, robustness/ruggedness, and specificity. All validation parameters met the acceptance criteria defined in the validation protocol.

Carboxypeptidase B↗

PubMed2004

[Effects of preparation and quality control of cryopreserved platelets].

The purpose of this study was to establish a set of techniques for cryopreservation of platelets with dimethylsulphoxide (DMSO) to insure high quality of cryopreserved platelet. The methods were as following: (1) DMSO was filtered in stead of being sterilized before infusion into the bag with platelets. (2) The whole blood was centrifuged immediately after blood collection and the attached tube was tied on the top of the bucket. (3) The related centrifugal force was 480 x g, the accelerating and braking grades of the centrifuge for acceleration and deceleration were 9 and 4 respectively. (4) The flow rate of platelet rich plasma (PRP) could not be too high, 80 - 100 ml PRP should be harvested at 1 minute or so. The infusion rate of DMSO into the PRP was 1 ml/min. After the infusion of DMSO, the PRP bag must be put into the -80 degrees C ultra low freezer at once to make the product to be freezed as soon as possible. The cryopreserved platelet should be thawed in the cycling warm water at the temperature of 38 - 40 degrees C. (5) After thawing of platelet, the platelet, red blood cell and white blood cell were counted, and the bacteria culturing, tests for HBsAg, anti-HCV, anti-HIV, TP and ALT were carried out. The results showed that altogether 14 800 units of cryopreserved platelets were prepared including 80 units collected with blood cell separator, of which quality control was accomplished in 300 units. The manually collected platelet mean count >/= 2.4 x 10(10)/unit, while the apheresis platelet count >/= 2.5 x 10(11)/unit. The yield was over 70%. The contaminated red and white blood cells were </= 1 x 10(9) and </= 1 x 10(7)/unit respectively. All the bacteria cultures were negative, while tests for HBsAg, anti-HCV, anti-HIV and TP were negative too. The ALT values were all in normal range. The transfusion of cryopreserved platelets showed obvious effect of haemostasis. In conclusion, the cryopreserved platelets prepared with this method were of high quality and efficaciousness in haemostasis clinically.

Blood Platelets↗

PubMed1977

The quality control of alkaline phosphatase determinations with placental phosphatase.

Human placenta has been recommended as the source of the alkaline phosphatase used for the preparation of control or reference materials. The effect of certain inhibitors, which may be present in the reagents, on control materials containing the placental isoenzyme, is shown to differ significantly from their effect on the isoenzymes in patient's sera. This finding indicates that if control materials are used which contain only human placental alkaline phosphatase, changes in accuracy resulting from differences in reagent quality may be missed, or alternatively a change in accuracy may be indicated by the quality control results which does not apply to the patient's sera.

Alkaline Phosphatase↗

PubMed1989

Medicare program; Utilization and Quality Control Peer Review Program; third Scope of Work for Peer Review Organizations.

This notice describes new requirements for the third Scope of Work for Utilization and Quality Control Peer Review Organizations (PROs) for fiscal year 1989, beginning October 1, 1988. This notice implements section 4091(b)(1) of the Omnibus Budget Reconciliation Act of 1987 (Pub. L. 100-203), which requires us to publish a new policy or procedure adopted by the Secretary that affects substantially the performance of contract obligations at least 30 days before the date the policy or procedure is to be used. It also implements other provisions of Pub. L. 100-203, as well as requirements of the Omnibus Budget Reconciliation Act of 1986.

Humans↗

PubMedDate not supplied

Quality control data for low blood lead concentrations by three methods used in clinical studies.

During several clinical studies of blood lead (BPb) concentrations from environmental exposure, quality control data for three different methods of BPb analysis were compiled. Anodic stripping voltammetry by a commercial method (cASV), a modified method (mASV), and graphite furnace atomic absorption spectrophotometry (GFAA) were compared for precision at low BPb concentrations (less than 25 micrograms/dL) analyses. Both duplicate and interassay precision, as well as direct determinations of intraassay precision, were less for GFAA. The mASV incorporated calibration with lower BPb standards than used in the commercial protocol. This appeared to correct nonlinearity in response at lower BPb and reduced the bias between ASV and GFAA at BPb concentrations typical of environmental exposure levels.

Electrochemistry↗

PubMed2006

Protein array staining methods for undefined protein content, manufacturing quality control, and performance validation.

Methods to assess the quality and performance of protein microarrays fabricated from undefined protein content are required to elucidate slide-to-slide variability and interpolate resulting signal intensity values after an interaction assay. We therefore developed several simple total- and posttranslational modification-specific, on-chip staining methods to quantitatively assess the quality of gel element protein arrays manufactured with whole-cell lysate in vitro protein fractions derived from two-dimensional liquid-phase fractionation (PF2D) technology. A linear dynamic range of at least 3 logs was observed for protein stains and immobilized protein content, with a lower limit of detection at 8 pg of protein per gel element with Deep Purple protein stain and a field-portable microarray imager. Data demonstrate the successful isolation, separation, transfer, and immobilization of putative transmembrane proteins from Yersinia pestis KIM D27 with the combined PF2D and gel element array method. Internal bovine serum albumin standard curves provided a method to assess on-chip PF2D transfer and quantify total protein immobilized per gel element. The basic PF2D array fabrication and quality assurance/quality control methods described here therefore provide a standard operating procedure and basis for developing whole-proteome arrays for interrogating host-pathogen interactions, independent of sequenced genomes, affinity tags, or a priori knowledge of target cell composition.

Animals↗

PubMed1999

Quality control of 99Mo/99Tcm generators: results of a survey of the Radiopharmacy Working Group of the Italian Association of Nuclear Medicine (AIMN).

A multicentre survey of the quality control of 99Tcm generators has been completed: 245 generators from seven different commercial sources were tested over a period of 2 years. The results indicate that the mean pH of the eluates was 5.8 +/- 0.6; the aluminium contents were typically < 10 ppm; the radiochemical purity was 99.8 +/- 0.4% and the median 99Mo content was 3.8 x 10(-4) percent. The elution profiles gave a volume of 1.9 ml to obtain 50% of the total eluted activity and of 4.9 ml to obtain 95%. Other radionuclide impurities and heavy metal breakthrough were evaluated by graphite furnace absorption spectrometry and inductively coupled plasma mass spectrometry. National guidelines for the standardization of radiopharmacy procedures are currently being compiled.

Hydrogen-Ion Concentration↗

PubMed1989

Quality control limits for the standard anaerobic reference agar dilution susceptibility test procedure of the National Committee for Clinical Laboratory Standards.

Multilaboratory studies were performed to develop MIC quality control limits for the National Committee for Clinical Laboratory Standards reference agar dilution method for anaerobic susceptibility tests. Acceptable MICs were defined as those which include greater than 95% of all 100 MICs generated by the study. Most MIC control limits included either 2- or 3-dilution intervals rather than the more traditional 3-dilution intervals that are described as the mode +/- 1 doubling dilution.

Amoxicillin↗

PubMed2000

Selection of an optimal combination of decision criteria for the internal quality control in an automatic analyzer.

After some years using an automatic analyser model Hitachi 705, we faced the task of selecting a reasonable combination of statistical procedures for internal quality control in order to use it in a computer program, by means of which, one could apply all the decision criteria in a rapid and automatic manner. As a result of the first 3 years of work, an algorithm was adopted that includes the multirule procedure originally proposed by Westgard, but with three main differences: (1) All the control rules are always applied; (2) the 4(1S) and 10x control rules are used as criteria for warning or caution but not for run rejection; and (3) the control limits are recalculated daily using all the accumulated control results (just the accepted values). The 2(2S), 4(1S) and 10x rules are applied first across materials (considering consecutive observations in different control materials), and then within materials (for consecutive observations on the same control material). The program not only has permitted us to improve our capacity for error detection, but it has also permitted the reduction of run rejections making an important decrease in costs possible and a significant improvement in quality.

Algorithms↗

PubMed1990

[Non-destructive quality control of tablets by photoacoustic infrared spectrometry. Analysis in primary packaging].

We have studied the feasibility of the photoacoustic detection in Fourier transform infrared spectrometry for the quality control of drug tablets. Beyond the non destructive character of the method, the main advantage which has been established is the precocity of impurity detection on the tablet outside. The direct recording of spectra through PVC lead to interesting results for study of tablets under blister.

Drug Packaging↗

PubMed1991

Quality control program on biological monitoring by Japan Federation of Occupational Health Organizations.

Since 1980, the Japan Federation of Occupational Health Organizations has been conducting an external quality control survey for biological monitoring under a contract with the Ministry of Labour of the Japanese Government. The number of participating organizations has increased from 91 in 1980 to 179 in 1987. The items in the program were lead and free erythrocyte protoporphyrin concentrations in blood, and lead, coproporphyrin, delta-aminolevulinic acid, chromium, hippuric acid, methylhippuric acid, total trichloro-compounds, mandelic acid, and phenol concentrations in urine. Evaluation was based on a scoring system. The scores were on the slope of major axis for probable ellipse, the slope of regression line, square root of error mean square for regression, performance indices, and the difference between 'true' and observed values of each sample. There was a gradual improvement in the evaluation scores as a function of time. The improvement was paralleled by the adoption of modern analytical methods such as flameless atomic absorption spectrometry for blood-lead measurement and high-performance liquid chromatography for urinary hippuric acid determination in many participants. These methods are simple in operation and reliable in performance. It was considered very probable that the program promoted the adoption.

Environmental Monitoring↗

PubMed2006

Two quality control exercises involving nucleic acid amplification methods for detection of Mycoplasma pneumoniae and Chlamydophila pneumoniae and carried out 2 years apart (in 2002 and 2004).

The quality performance of laboratories for the detection of Mycoplasma pneumoniae and Chlamydophila pneumoniae by two quality control (QC) exercises with a 2-year interval was investigated. For the 2002 QC exercise, specimens were spiked with M. pneumoniae at concentrations of 5,000, 500, 50, and 0 color-changing units (CCU)/100 microl. The limit of detectability was 50 CCU/100 microl. Therefore, this concentration was omitted from the 2004 panel and was excluded from the analysis. In 2002, 2 out of 12 participants obtained 100% correct results, 2 out of 12 produced false-positive results, and 10 out of 12 had between 0 out of 9 and 8 out of 9 correct positive results. In 2004, correct results were obtained in 15 out of 18 tests, and no false-positive results were reported. In 2002, specimens were spiked with C. pneumoniae at concentrations of 490, 49, 4.9, and 0 inclusion-forming units/100 microl (IFU/100 microl). In the 2004 panel, samples spiked with a lower dilution of 0.49 IFU/100 microl were added to the panel. For the C. pneumoniae QC, correct results were produced in 12 out of 16 and 13 out of 18 tests in 2002 and in 2004, respectively. Both multiplex PCR and nucleic acid sequence-based amplification (NASBA) formats scored a smaller number of samples positive than the monoplex reactions.

Bacteriological Techniques↗

PubMed1987

Quality control limits for microdilution susceptibility tests with aztreonam, imipenem, ceftriaxone, ceftazidime, ceftizoxime, cefuroxime, and cefonicid.

A six-laboratory collaborative study was performed in order to define quality control limits for microdilution tests with seven new beta-lactams (aztreonam, imipenem, ceftriaxone, ceftazidime, ceftizoxime, cefuroxime, and cefonicid). Four standard control strains were tested and the expected MIC limits for each of the appropriate drug-microorganism combinations were defined.

Anti-Bacterial Agents↗

PubMed1994

Integrated quality control project: relationships between pathological findings detected at the slaughterhouse and information gathered in a veterinary health scheme at pig farms.

In September 1986 an Integrated Quality Control Project (IQC) was started in the Netherlands. Over a period of 2 years a veterinary herd health scheme was applied to 21 growing and finishing pig herds. Information was collected concerning medical treatment, classified as group treatment and individual treatment, clinical observations, and housing factors. The main purpose of this project was to investigate relationships between pathological findings detected at the slaughterhouse and information gathered on the farm. Medical group treatments, clinical observations and housing did not reliably predict pathological findings. Individual medical treatment for respiratory disorders, started in the last 30 days before slaughter, proved to be positively related to the pathological findings 'pneumonia' and 'pleuritis' detected at the slaughterhouse. This may be useful for selecting pigs at the slaughterhouse that will require special treatment for the removal of the pleura parietalis. During the first year of the project the average daily gain (ADG) was 27.2 g. more than during the preceding 2 years (P < 0.0001). Coughing was negatively related with the ADG. More than 75 coughs per compartment during 10 minutes, recorded more than 50 days before slaughter, was positively related to a depression of the ADG (20 g; P < 0.05). Relationships between group medical treatments and ADG were statistically significant, when the group medical treatment was started more than 20 days before slaughter. Negative influences on the ADG were higher if the treatment was started closer to the slaughter date.(ABSTRACT TRUNCATED AT 250 WORDS)

Abattoirs↗

PubMed1999

Development and validation of a high-performance liquid chromatographic stability-indicating method for the analysis of Synercid in quality control, stability and compatibility studies.

A gradient high-performance liquid chromatographic (HPLC) method was developed for the analysis of Synercid freeze-dried powder in routine quality control, stability and compatibility studies. This method is suited for a simultaneous assay of drug substances and impurities. The method was validated for precision, reproducibility, linearity, accuracy and limits of detection. The robustness study that was performed according to an experimental design is described.

Anti-Bacterial Agents↗

PubMed1995

A test pattern for quality control of laser scanner and charge-coupled device film digitizers.

Although clinical images provide the ultimate test of diagnostic performance for a film digitizer, such images are not generally suitable for daily quality control (QC) purposes. However, a well-designed test pattern will provide a rapid, comprehensive, objective and reproducible assessment of image quality. This pattern should evaluate various parameters of image quality, including high contrast resolution, low contrast discrimination, linearity of gray scale, geometric distortion, and noise. Furthermore, the pattern should detect light leak and film slippage, two problems commonly associated with film digitizers. The test pattern described in this manuscript was designed to provide quantitative measures of performance for a film digitizer. As part of a regular QC routine for a laser scanner or charge-coupled device digitizer, this pattern provides a simple method to identify and quantify changes in digital image quality.

Artifacts↗

PubMed2001

Electronic "Quality Control" (EQC): is it just for unit use devices?

The US Clinical Laboratory Improvement Amendments of 1988 (CLIA'88) mandated daily quality control (QC) for all laboratory tests. CLIA'88 clearly envisioned traditional, matrix-based controls. However, recent interpretations allow routine use of "electronic" controls (EQC). These surrogate controls, reference cassettes, glass filters, electronic signals, etc., evaluate the photometric, electronic and computational components of the test system. EQC does not evaluate chemical reactions, sample and reagent manipulations, etc. When compared to traditional concepts, it represents a discontinuity in logic and subverts the fundamental purpose of QC. The advent of "unit-use" test systems (reagent packs, cassettes, cartridges, etc.) used primarily in decentralized testing locations opened the door to EQC. The rationale behind EQC is that if the test system is operating within specifications and the manufacturer reliably delivers consistent and uniform quality products, a simple electronic check will assure that the entire testing process is in control. Unrecognized test system failure is the most insidious problem facing today's instruments using EQC-based systems. We cite positive and negative examples. We also ask, "If EQC is accepted, from a regulatory perspective for some instruments, why not for all?" Is the next step universal EQC, for all systems, inevitable?

Electronics↗