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At least 163 records · Page 9Linked to original sources
PubMed1993

Quality control guidelines for cefdinir, cefepime, cefetamet, cefmetazole, cefpodoxime, cefprozil, and clinafloxacin (CI-960) for various National Committee for Clinical Laboratory Standards susceptibility testing methods. Quality Control Study Group.

Several multilaboratory studies to determine quality control (QC) ranges for a variety of National Committee for Clinical Laboratory Standards (NCCLS) susceptibility tests are summarized. Replicate testing used multiple lots of media and antimicrobial disks in accordance with NCCLS recommendations, including the appropriate medium modifications for tests with Haemophilus spp. and Neisseria gonorrhoeae. QC ranges for MIC and disk diffusion testing of N. gonorrhoeae ATCC 49226 were proposed for cefepime, cefetamet, cefmetazole, and cefpodoxime. Disk diffusion QC ranges for Haemophilus influenzae ATCC 49247 or ATCC 49766 were recommended with cefepime, cefetamet (10- and 30-microgram disks), cefmetazole, cefpodoxime, and cefprozil. Disk diffusion QC ranges for Staphylococcus aureus ATCC 25923 and Escherichia coli ATCC 25922 with cefdinir and clinafloxacin and those for Pseudomonas aeruginosa ATCC 27853 with clinafloxacin were also proposed.

Anti-Infective Agents↗
PubMed1980

Quality control of hospital discharge data.

Data based on medical records of discharged hospital patients are widely used. However, recent studies of the reliability of discharge data have found error rates which appear to be high, in view of the important data uses. In this paper, the procedures reportedly followed to control the quality of discharge data by private abstracting services, the national Hospital Discharge Survey and the Medicare system are described. Some weaknesses of the quality controls of the existing systems are identified. Recommendations are made for reducing duplicate data collection efforts, and for studies of the relative effectiveness and costs of various quality control procedures.

Evaluation Studies as Topic↗
PubMed1994

Quality control for evaluation of the S-phase fraction by flow cytometry: a multicentric study. The SICCAB Group for Quality Control of Cell Kinetic Determinations.

Flow cytometric measurement of the S-phase fraction (FCM-S) may be clinically useful in human cancers to identify high-risk patients. However, its clinical application requires a methodologic standardization, a high feasibility, and the reproducibility of results within the same and among different institutions. The interlaboratory quality control program for FCM-S determination (promoted by the Italian Society of Basic and Applied Cell Kinetics) was carried out on DNA diploid and aneuploid cell lines and human breast cancers. FCM-S was quantified by using four mathematical models characterized by different rationales and differences in the degree and shape of background subtraction functions. A satisfactory agreement in FCM-S values among different institutions was observed for cell lines. In human breast cancers, a high reproducibility of FCM-S estimates obtained by the different institutions was observed by using the same model. Conversely, different models gave different FCM-S estimates. Intermodel differences were more evident in aneuploid than in diploid tumors. These findings could explain the contrasting results on the prognostic role of FCM-S in clinically comparable series of breast cancers and should be considered in future efforts to define the optimal and most reproducible mathematical approach to quantify cells in the S-phase.

Aneuploidy↗
PubMed2006

Autophagy: an ER protein quality control process.

Protein quality control processes active in the endoplasmic reticulum (ER), including ER-associated protein degradation (ERAD) and the unfolded protein response (UPR), prevent the cytotoxic effects that can result from the accumulation of misfolded proteins. Characterization of a yeast mutant deficient in ERAD, a proteasome-dependent degradation pathway, revealed the employment of two overflow pathways from the ER to the vacuole when ERAD was compromised. One removes the soluble misfolded protein via the biosynthetic pathway and the second clears aggregated proteins via autophagy. Previously, autophagy had been implicated in the clearance of cytoplasmic aggresomes, but was not known to play a direct role in ER protein quality control. These findings provide insight into the molecular mechanisms that result in the gain-of-function liver disease associated with both alpha1-deficiency and hypofibrinogenemia (abnormally low levels of plasma fibrinogen, which is required for blood clotting), and emphasize the need for a more complete understanding of the molecular mechanisms of autophagy and its relationship to protein quality control.

Autophagy↗
PubMed1998

Provisional quality control parameters and interpretive criteria for testing susceptibility of Streptococcus pneumoniae and Haemophilus influenzae to quinupristin/dalfopristin (RP59500). Antimicrobial Testing Quality Control Group.

Studies were undertaken to select tentative criteria for susceptibility testing of quinupristin/dalfopristin against Streptococcus pneumoniae and Haemophilus influenzae. Against 612 isolates of Streptococcus pneumoniae, MICs of quinupristin/dalfopristin were < or = 1.0 microg/ml for all but one strain. With a tentative MIC breakpoint of either < or = 1.0 microg/ml or < or = 2.0 microg/ml for susceptible, a disk diffusion zone diameter breakpoint of > or = 19 mm embraced all but two of the susceptible pneumococci; > or = 16 mm included all strains. For Haemophilus influenzae, MICs of quinupristin/dalfopristin clustered near the tentative breakpoints; 91.5% of the MICs were 2.0 to 8.0 microg/ml. This precluded satisfactory performance of the disk diffusion test in discriminating between resistant and susceptible isolates unless MIC breakpoints are modified for this species: clinical experience will be needed before that can be justified. Based on data from a multilaboratory study, the following quality control limits are proposed for Streptococcus pneumoniae ATCC 49619 when testing quinupristin/dalfopristin: 0.25 to 1.0 microg/ml for broth microdilution tests and 19 to 24 mm for disk diffusion tests. For tests of Haemophilus influenzae ATCC 29247, MIC limits are 2.0 to 16 microg/ml; disk tests were very reproducible but are not yet recommended.

Anti-Bacterial Agents↗
PubMedDate not supplied

The importance of internal quality control data in National External Quality Assessment schemes. Plasma progesterone assays.

Co-ordinators of external quality assessment schemes in the U.K. despatch samples of quality control material to participant laboratories at frequent intervals to assess laboratory performance. We show, via a controlled experiment on the plasma progesterone assay, that the current analysis performed by the external assessors is inadequate and often leads to erroneous conclusions about a laboratory's performance. It is concluded that for a proper assessment of a laboratory's performance, the external assessor should prepare large pools of plasma and distribute them to all participants in the scheme to use as internal quality control material.

Chemistry Techniques, Analytical↗
PubMed2004

First results of Lichtenstein hernia repair with Ultrapro-mesh as cost saving procedure--quality control combined with a modified quality of life questionnaire (SF-36) in a series of ambulatory operated patients.

There are about 200,000 hernia repairs per year in Germany and about 770,000 in the U.S. In the United States most hernia repairs (80-90%) are performed as day surgery procedure; 90% of operations are open herniorrhaphies with mesh. Quality control includes the registration of complications, recurrence, and quality of life. In a prospective study 50 consecutive patients with inguinal hernia eligible for open mesh repair (modified Lichtenstein hernia repair), mostly Nyhus III and IV classification, were operated using light-weight Ultrapro-mesh (monocryl-prolene-composite, Ethicon Products), and interviewed 10 days after the operation according to a modified SF-36 questionnaire. Patients were examined three months later. There were 29 direct hernias, 21 combined (direct and indirect) hernias, 8 indirect hernias; 8 patients had hernias on both sides. 8 patients (16%) presented with recurrent hernias, mostly suture or laparoscopic repairs before. There were no intra-operative complications. 2 patients suffered from a moderate haematoma, which did not necessitate a surgical repair, after accidental intake of aspirin preoperatively in one case and after preoperative low-molecular-weight heparin prophylaxis. There were no other complications. All 50 patients (100%) had returned the questionnaire. 38 patients (78%) reported no or mild pain; only one patient (2%) suffered from severe pain, none had very severe pain. 32 patients (64%) applied no pain medication or only for 48 hours; only one patient (2%) used pain medication for more than 14 days. 34 patients (68%) admitted that their health status improved after the operation; 11 patients (22%) with good or very good health status indicated no change in health. Follow-up examination of the patients three months after the operation did not detect any recurrence. 49 patients (98%) were free of pain or restriction; one patient (2%) continued to have chronic pain which developed after two laparoscopic herniotomies performed at a different clinic before. There was no sign of mesh-related complication. The Ultrapro-mesh has been well accepted by the patients. In conclusion, open mesh repair according to Lichtenstein is safely done in specialised ambulatory day surgery clinics. Most patients benefit from this form of treatment according to a quality of life audit. The new light-weight mesh Ultrapro contributes to the improvement of hernia repair. There is evidence that ambulatory open mesh repair should be the method of choice for primary inguinal hernia. If in Germany an equal proportion of hernia repair as in the United States would be done as ambulatory procedure (80-90%), there would be an annual cost saving of several hundred million Euro.

Adolescent↗
PubMed1972

The MEDLARS demand search quality control program.

A Quality Control Unit was established at the National Library of Medicine to provide preventive quality control on a continuing basis for MEDLARS. This unit provided analyses of retrievals and made recommendations for improvements based upon these analyses. For the period January 1969 to June 1970, 21,000 MEDLARS searches were released in the United States. Appraisals were returned by 24.4% of the users. They reported that 55% of the citations retrieved were relevant and that 47% of the citations were new to them; 70.6% of the users reported recall of 50% or higher.

Information Systems↗
PubMed2002

[Quality control 2001].

The quality control comprises of accounts and the identification of ten taxas on blind blades. The article gives the list of these pollens and details the answers. The rate of exact recognitions is 81.34% and 52 analysts out of 54 took part in the quality control.

Environmental Monitoring↗
PubMed1994

Minimum inhibitory concentration quality-control guidelines for biapenem, DU-6859a, FK-037, levofloxacin, grepafloxacin, and ceftizoxime when using various National Committee for Clinical Laboratory Standards susceptibility test methods. Quality Control Study Group.

Several multilaboratory collaborative studies using broth microdilution and agar dilution (gonococcal tests only) methods of susceptibility testing were performed to establish quality-control (QC) giudelines. Replicate dilution tests with multiple lots of media were performed with National Committee for Clinical Laboratory Standards recommended QC strains (Escherichia coli ATCC 25922, Pseudomonas aeruginosa ATCC 27853, Enterococcus faecalis ATCC 29212, and Staphylococcus aureus ATCC 29213) by using the following antimicrobials: biapenem, DU-6859a, FK-037, levofloxacin, and grepafloxacin. In addition QC MIC ranges, using appropriate medium modification for Haemophilus influenzae ATCC 49247 and Neisseria gonorrhoeae ATCC 49226 were reported on four (DU-6859a, FK-037, levofloxacin, and grepafloxacin) and two (ceftizoxime and FK-037) antimicrobials, respectively.

Anti-Bacterial Agents↗
PubMed1986

The state of quality control: a critique.

Quality control of clinical laboratory testing must ultimately assure that test results consist of medically reliable information that is received where needed, when needed. This review shows that, despite the sophistication and complexity of current quality control procedures, numerous problems continue to prevent the achievement of this ideal. Solutions to some of these problems are suggested.

Laboratories↗
PubMed1964

QUALITY CONTROL OF PHARMACEUTICALS.

Quality control is an essential operation of the pharmaceutical industry. Drugs must be marketed as safe and therapeutically active formulations whose performance is consistent and predictable. New and better medicinal agents are being produced at an accelerated rate. At the same time more exacting and sophisticated analytical methods are being developed for their evaluation. Requirements governing the quality control of pharmaceuticals in accordance with the Canadian Food and Drugs Act are cited and discussed.

Canada↗
PubMed1999

Sample preparation for peptide mapping--A pharmaceutical quality-control perspective.

In quality control of therapeutic proteins peptide mapping is used for confirmation of primary structure and detection of posttranslational modifications. The demands put on the experimental procedure are therefore different than in the case of determination of an unknown protein structure. It is here recognized that a peptide-mapping method for quality control of proteins should be inert (not induce or revert modifications), general, robust, and allow a high sample throughput. The steps prior to the separation of the generated peptides are identified as crucial for meeting these demands. This includes denaturation, reduction, alkylation, buffer exchange, solubilization, and digestion. A critical review of the literature regarding these steps is presented. Relevant options in all steps are experimentally evaluated. Novel approaches are developed for many of the steps. The result is a sample preparation procedure that essentially meets the stated demands.

Alkylation↗
PubMed1983

Essential elements of quality control.

The components of quality control in the pharmaceutical industry are discussed as they apply to hospital pharmacy admixture services. The pharmaceutical industry complies with the FDA's Current Good Manufacturing Practices, which require manufacturers to have written procedures for ensuring sterility and nonpyrogenicity of injectable products. Because FDA specifies only what outcome measures must be assessed (rather than specific means of assessment), pharmaceutical companies have developed a multiplicity of quality-control systems. However, each system consists of a master formula (quantitative listing of all ingredients), master manufacturing instructions (the recipe for each product), master packaging instructions, and batch records. Documents used by quality control personnel include the specifications (identification, tests, and limits for products), test methods, and sampling procedures. Hospitals should have similar quality-control programs. These programs should systematically prevent or identify and correct deficiencies, measure overall quality, and provide information for managers. Hospital pharmacists whose departments do not have comprehensive programs should consult colleagues who have developed such procedures. Techniques used in industry should be applied when possible. To protect the integrity of manufacturers' drug products during compounding in hospitals, every hospital admixture service must have its own quality-control system.

Documentation↗
PubMedDate not supplied

[Increasing quality control in Russia's health care system: new goals and new means].

Presents a territorial system for controlling the quality of medical care rendered in the district, which helps not only react to the final results of medical service (reaction to a detected defect), but rather prevent the flaw. A programmed purposeful approach to the creation of a system for quality control helps it integrate in the universal system of public health management both at the territorial and municipal level.

Health Planning↗
PubMed2005

[Wound infection and infection-promoting factors in breast cancer surgery -- a prospective multicenter study on quality control].

INTRODUCTION: The quality of treatment of cancer of the female breast is reflected not only in such parameters as local recurrence rate and survival times, but also in the development of surgical complications. Within the framework of a study investigating the performance and quality assurance in surgical treatment of breast cancer, therefore, the wound infection rate (WIR) and factors influencing it were analysed in a large patient population. METHODS: In the period between 1.1.2000 and 31.12.2000, 84 surgical departments participated in a prospective multicenter study to investigate primary surgery for breast cancer. A total of 1 416 patients were recruited to the study, the organization and conduction of which was in the hands of the former surgical department 1 of the University of Leipzig under the patronage of the East German Working Group for Performance and Quality Control in Surgery in cooperation with the An Institute for Quality Control in Operative Medicine of the Otto-von-Guericke University in Magdeburg. In addition to parameters characterizing patients, tumors and diagnostic work-up, we also analysed the surgical treatment and its possible complications with the aid of a questionnaire. The definition of wound infection was based on the criteria of the "Hospital Infection Control Practice Advisory Committee". RESULTS: The overall WIR was 4.5 % (n = 65). 21 (32 %) of the wound infections (WI) were diagnosed exclusively on a clinical basis without establishing the responsible pathogens. In 44 (68 %) of the WI, a search for the pathogen was undertaken which in 3 cases (7 %) was negative, and in 41 cases (93 %) positive. 118 (8.3 %) of the patients received perioperative antibiotic cover. The following parameters were found to have a significant influence on WIR: local drainage, blood transfusion, the time lapse between biopsy and definitive surgery, and the size of the primary tumor. DISCUSSION: Some of the above factors (transfusion, time lapse, drainage) can be influenced by the therapist. The wound infection rate is a marker for treatment quality.

Adult↗
PubMed1984

Nested control procedures for internal analytical quality control. Theoretical design and practical evaluation.

A quality control system has been developed and evaluated for three Greiner automatic analyzers. The control system was built in a hierarchical way with different statistical rules for different stages of the analytical process. Computer simulation techniques were found to be very helpful in grasping the quantitative aspects of various design features. In the practical evaluation of the control system the calculated rates of false rejections were of the same order as the theoretical value of 0.01 in most cases, and the estimated frequencies of analytical disturbances varied between 0 and 0.25.

Autoanalysis↗