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PubMed1979

[Simultaneous determination of antiepileptic drugs in clinical laboratories: Problems of quality control and standardization (author's transl)].

Methods for determination of antiepileptic drugs in clinical laboratories are discussed with respect to precision, constant error control and economy. Experimental data for reproducibility and standardization are presented for gas chromatographic and photometric methods. Methods for choosing the most suitable procedure for any of the common analytical tasks that may arise in the clinical laboratory are recommended.

Anticonvulsants↗
PubMed1978

Guiding principles and recommendations on labelling of clinical laboratory materials: a WHO memorandum.

Comprehensive labelling forms a vital part of any steps to control the quality of commercially distributed diagnostic reagents. This Memorandum gives recommendations for such labelling. Specifications are given for the recommended minimum information to be given on the label attached to the immediate container of clinical laboratory materials, kits and kit components, reference materials including calibrators and control materials, and where applicable, of general laboratory materials. A package insert or brochure is generally required for clinical laboratory materials, kits, and reference materials, and specifications are also given for information to be given in such inserts or brochures. Definitions of terms used in this Memorandum are given in an Annex. It is hoped that WHO Member States will use these specifications through their adoption as national regulations.

Clinical Laboratory Techniques↗
PubMed1977

From professional monopoly to corporate oligopoly:the clinical laboratory industry in transition.

Until the mid-1960s the nonhospital clinical laboratory industry was dominated by pathologists. The ethics of medical professionalism protected the pathologists' market from price competition and from any serious threat from new entrants into the market. Immune from the competitive pressures of the marketplace, pathologists exerted monopoly control in local markets. That power was eroded by laboratories operated by technologists and bioanalysts and was finally overcome by the entry of large corporations into the industry. The market power of the largest corporate laboratories is now growing to a point where competition may again be thwarted. The professional ethics of pathologists allowed high prices, but there was little push toward higher volume. The commercial ethics of the corporate entrants brought lower prices but resulted in strong pressure for greater test quantities. In either case, the power wielded by the dominant producer would seem to go against the consumer's interests.

Automation↗
PubMed1978

Computerization of clinical laboratory procedure manuals.

Current code requires federally licensed clinical laboratories to have standard operating procedure manuals describing all tests performed. A computerized system for generating, revising, and excerpting manuals, which produces hard copy and microfiche, has been developed and appears to meet the regulatory criteria. The salient aspects of pertinent federal regulations, the features of the computerized system, the format of the manual, the users' experience therewith are described.

Computers↗
PubMed1978

An approach to cost analysis of clinical laboratory services.

The authors have developed a system that provides information about costs related to specific laboratory tests. These costs are derived from: (1) labor and material actually used for specific tests; (2) allocation of costs for labor and material shared by several different tests; (3) allocation of supervisory and management costs. The "cost" of a specific procedure is a theoretical construct that is significantly affected by the method chosen for allocation. We know of no cost-analysis system generally accepted by all clinical laboratories. Since third-party payers may base future reimbursement on costs rather than charges, accurate systems for clinical laboratory cost analysis may have some practical value.

Clinical Laboratory Techniques↗
PubMed1978

Evaluation of the counterimmunoelectrophoretic (CIE) procedure in a clinical laboratory setting.

The counterimmunoelectrophoretic (CIE) procedure was evaluated under clinical laboratory conditions to determine its validity and comparability with culture methods. The procedure was further evaluated to determine applicability to a variety of clinical samples. An inexpensive set-up was developed to utilize the CIE procedure at bench level. Results indicated the procedure to be sensitive in detecting Haemophilus influenzae, type b, and Neisseria meningitidis (meningococcus), group B. The procedure was more sensitive for detection of H. influenzae, type b, than for meningococcus, group B. The authors have confirmed the usefulness of the CIE procedure in the detection of group B streptococci, pneumococci and teichoic acid antibody to Staphylococcus aureus. Detection of Escherichia coli K 1 antigen was also accomplished by CIE. In the authors' laboratory the CIE procedure was superior to culture methods when used for the detection of H. influenzae, type b, and meningococcus group B.

Animals↗
PubMed1977

Enzymatic degradation of polygalacturonic acid by Yersinia and Klebsiella species in relation to clinical laboratory procedures.

As scored by several specified plating procedures, clinical and environmental strains of Yersinia enterocolitica, Yersinia pseudotuberculosis, and Klebsiella pneumoniae "Oxytocum" showed detectable, albeit generally weak, ability to digest polygalacturonic (pectic) acid. None of these bacterial strains had the vigorous and rapid pectolytic activity on these polygalacturonic acid-containing media that is typical of soft-rot Erwinia species, although some of the Oxytocum strains came fairly close. Analyses of the pectolytic enzyme contents of the cells and culture supernatants of the Yersinia and Klebsiella species revealed that readily detectable quantities of cell-bound polygalacturonic acid trans-eliminase and hydrolytic polygalacturonase were formed by the Yersinia and Klebsiella species; however, the total units of enzyme activity produced by these bacteria were, in general, lower than were produced by soft-rot Erwinia species. Furthermore, unlike the situation in soft-rot Erwinia cultures, these pectolytic enzymes of Yersinia and Klebsiella species were not excreted rapidly and massively into the growth medium. Cultures of other enterobacteria (Citrobacter species, Enterobacter species, Erwinia amylovora, Erwinia herbicola, Escherichia coli, Proteus species, Salmonella typhimurium, and Serratia marcescens) showed no pectolytic ability whatsoever by any of the plating procedures used and (to the extent they were so examined) produced no pectolytic enzymes detectable either in their cells or culture supernatants. This slow or weak release of pectolytic enzymes by Yersinia and Klebsiella species has a bearing on clinical laboratory procedures suitable for detecting their pectolytic activity; methods adequate for this purpose are detailed.

Bacteriological Techniques↗
PubMed1978

The identification of pseudomonads and related bacteria in a clinical laboratory.

Non-fermenting, catalase-positive Gram-negative bacilli that grow on nutrient agar are often isolated in clinical laboratories. We have applied biochemical techniques appropriate to a typical clinical microbiology laboratory, and for the most part described in Cowan and Steel's Manual for the identification of medical bacteria (Cowan, 1974), to 428 clinical isolates and have evolved a scheme for their identification. Organisms were subdivided into groups on the basis of three tests, namely the glucose oxidation-fermentation test and tests for oxidase activity and motility. A choice was then made among other tests to produce indentification tables, containing only the most useful tests, for the various groups. The most complicated table has only 16 tests. This simple system identified 96.5% of the 428 organisms, as well as many subsequent isolates of the more common organisms.

Acinetobacter↗
PubMed1978

The predictive value of clinical laboratory test results.

Bayes' formula is being used with increasing frequency to calculate predictive values for positive and negative clinical laboratory test results. Because of its nonlinear form, however, it is difficult to visualize how changes in the test characteristics or disease prevalence will effect predictive values. This paper shows that Bayes' formula is transformed to a linear function through the use of odds, rather than probabilities, thus facilitating conceptualization, understanding, and memory.

Bayes Theorem↗
PubMed1978

Adoption of a manual kinetic gamma-glutamyl transferase method in the clinical laboratory.

Following our recommended protocol for establishing analytical methods in a clinical laboratory, a rapid, simplified manual kinetic method for determining Gamma-Glutamyl Transferase activity in serum was adopted to meet the needs of our laboratory. The steps taken, from the selection of the assay conditions through the introduction of the new test ot staff physicians, are described. The assay, which requires only 50 microliter of serum or plasma, uses L-gamma-glutamyl-p-nitroanilide as the substrate, and is controlled at 30C and a pH of 8.20. The reaction is monitored by the increase in absorbance at 405 nm. Up to 30 samples per hour may be analyzed using a manual spectrophotometer. The substrate is simple to prepare and is stable for one working day at room temperature and for at least one month for frozen at -20C.

Biliary Tract Diseases↗
PubMed1979

Analytic clinical laboratory precision. State of the art for twenty-nine analytes.

Relationships of concentration and coefficient of variation are described for 29 clinical laboratory analytes. Estimated mean regression curves and the standard deviations of individual laboratory coefficients of variation about the mean regression are calculated. Twenty-seven analytes showed a significant relation between concentration and coefficient of variation. State of the art precision is compared to medical goals. The average coefficient of variation for one analyte, calcium, fails to meet medical goals for manual methods. The distribution of individual laboratory precision above average state of the art figures is discussed. The proportion of laboratories failing to meet medical goals is large for osmolality, as well as manual calcium methods.

Analysis of Variance↗
PubMed1978

Use of a clinical laboratory computer to warn of possible drug interference with test results.

Using a clinical laboratory computer system, software has been developed which checks to determine if the result of any test performed on a patient specimen may be affected by any drug administered to that same patient. If possible interference is detected, a comment is automatically attached to the result on the patient's computer-generated report warning the attending physician the result may be falsely elevated or lowered.

Chemistry, Clinical↗
PubMed1978

Quality assurance practice in rural and urban hospital clinical laboratories.

This survey examined quality assurance practice in matched pairs of rural and urban hospital clinical laboratories. Questions directed at personnel qualifications, laboratory management, internal quality control mechanisms, and proficiency testing enrollment revealed no major differences between the rural-urban pairs. Deficiencies observed were either generic or size-related. Most laboratories were directed by physicians; however, almost half spent 5 or less hours per week in the laboratory. All respondents employed at least one individual professionally certified at the "technologist" level. Virtually all respondents insisted they employ a laboratory management system for ensuring quality performance, although 20% did not document their practice. Internal quality control practice varied widely. Many respondents recognized shortcomings related to volume and budget, and requested specific training courses for technical personnel. At least 20% of the laboratories were not enrolled in any recognized proficiency testing program, an integral part of the total quality assurance process.

Blood Banks↗
PubMed1978

Clinical laboratory abnormalities and their follow-up in a mental hygiene clinic.

In a retrospective study, there were clearly abnormal laboratory findings in 4.8 per cent of 4,994 adults who attended for psychiatric evaluation at a mental hygiene clinic. In particular high fasting blood sugars, abnormal blood counts, eosinophilia, VDRL and abnormalities of chest X-ray or urinalysis were found. Just under half of these abnormalities led to further medical follow-up. Old and young, schizophrenic and neurotic were equally likely to be followed up, but tests which were clinically not alarming might be ignored. The implications are discussed.

Adolescent↗