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A dynamic computer system for the clinical laboratory.

The Clinical Laboratory Computer System currently in use at the Medical University of South Carolina is described. Not only is the existing hardware listed and shown in some detail, but also the workload, laboratory data center personnel, typical procedures, and examples of selected input and output documents are included. Particular emphasis is placed on the dynamic nature of the system, which allows the user to proceed easily in developing new programs as the requirements of the laboratory continue to change and grow. To illustrate this point, programs written by the user are described in general terms.

Computers

Effective utilization of clinical laboratories.

Effective utilization of clinical laboratories requires that underutilization, overutilization, and malutilization be appreciated and eliminated or reduced. Optimal patient care service, although subjective to a major extent, is reflected in terms of outcome and cost. Increased per diem charges, reduced hospital stay, and increased laboratory workload over the past decade all require each laboratory to examine its internal operations to achieve economy and efficiency as well as maximal effectiveness. Increased research and development, an active managerial role on the part of pathologists, internal self-assessment, and an aggressive response to sophisticated scientific and clinical laboratory data base requirements are not only desirable but essential. The importance of undergraduate and graduate medical education in laboratory medicine to insure understanding as well as effective utilization is stressed. The costs and limitations as well as the accuracy, precision, sensitivity, specificity, and pitfalls of measurements and examinations must also be fully appreciated. Medical malpractice and defensive medicine and the use of critical values, emergency and routine services, and an active clinical role by the pathologist are of the utmost value in assuring effective utilization of the laboratory. A model for the optimal use of the laboratory including economy and efficiency has been achieved in the blood bank in regard to optimal hemotherapy for elective surgery, assuring superior patient care in a cost effective and safe manner.

Clinical Laboratory Techniques

Clinical laboratories. Profit center, production industry or patient-care resource?

The clinical laboratory is an essential component of the medical-care system. Rapidly increasing expenditures for laboratory services, fraudulent practices and reports of laboratory error are precipitating legislative and regulatory actions that will affect clinical laboratories and how they are used by physicians in caring for their patients. Many problems related to clinical laboratories are due to the rapid introduction of new technologies, to methods of educating medical students and house officers, to the rapidly expanding scientific base of medicine and to economic factors that have subordinated medical and scientific objectives in the laboratory to economic ones. Implementation of existing legislation would settle many of the economic issues, but more effective integration of the clinical laboratory into the patient-care process and better methods for educating medical students in the use of laboratory information are critical tasks for the medical profession.

Accounting

Analytical performance and comparability of the determination of triglycerides by 12 Lipid Research Clinic laboratories.

Twelve Lipid Research Clinic laboratories performed automated fluorometric triglyceride analyses on four control serum pools of known concentration by a modified Hantzsch reaction. The analyses were done during a two-year period, with use of common standards, methodology, and quality-control procedures. Estimates of analytical bias, variability, and short- and long-term trends for each instrument and for the entire group of LRC instruments are presented. High accuracy, precision, and interlaboratory comparability were achieved through rigorous standardization and control of the entire analytical procedure. Individual instrument biases varied from an average of 4.9% below to 1.0% above reference values. Between-run variability was often less than within-run variability and interlaboratory variation was substantially less than intralaboratory variation. The total standard deviation for all instruments ranged from 37 to 63 mg/liter. Only 5 to 14% of this variation was due to differences among instruments. The among-instruments standard deviation ranged from 12 to 17 mg/liter; the between-run, within-instrument standard deviation ranged from 29 to 46 mg/liter, and within-run standard deviation from 27 to 40 mg/liter. The significance of the results for long-term collaborative studies is discussed.

Analysis of Variance

Safety procedures in clinical laboratories.

Five types of hazards encountered in the clinical laboratory and a list of safety procedures designed to avoid or minimize them are identified. The safety procedures are written in a precise and easy-to-follow manner so that they can be adopted and used in any clinical laboratory. Medical technology educators are encouraged to teach safety procedures and enforce them in the student laboratory.

Accidents, Occupational

Congenital obstructive lesions involving the major pulmonary veins, left atrium, or mitral valve: a clinical, laboratory, and morphologic survey.

The clinical, laboratory, and morphologic features of congenitally obstructive lesions causing pulmonary venous hypertension are reviewed. These lesions are responsible for considerable infant mortality and morbidity, especially in the first weeks of life, are not infrequently encountered in older children, and are occasionally seen in adults. The presence of a malformation causing pulmonary venous hypertension often can be detected clinically, but precise anatomical and physiological diagnoses, usually necessary for optimal patient management, often can be made only by detailed laboratory study. Cardiac catheterization and angiocardiography remain the prime modes of accurate diagnosis in such patients, many of whom have other significant cardiovascular malformations, and echocardiography is an extremely useful adjunct, especially in patients with mitral valvular stenosis, hypoplasia, or atresia. The only definitive treatment in any of these patients is operative relief of the obstruction, and the chances of success depend not only on the skill of the surgeon, but also on the nature of the obstructing lesion, the types of associated malformations, and the precision with which these are defined preoperatively.

Adult

Effect of flurazepam on common clinical laboratory tests.

Twenty-two clinical laboratory tests performed on blood samples from 16 normal subjects following one week of either flurazepam or placebo administered in a double-blind method showed no apparent chemical interference by flurazepam on any of the testing procedures.

Adult

Transmission of hepatitis B virus in clinical laboratory areas.

The transmission of hepatitis B virus (HBV) in clinical laboratory areas was delineated by the use of hepatitis B surface antigen (HBsAg) as presumptive evidence for the presence of the infective agent. Twenty-six (34%) of 76 environmental surfaces sampled were positive for HBsAg. The outer surfaces of blood- and serum-specimen containers had HBsAg contamination rates of 55% (six of 11) and 44% (four of nine), respectively. Subsequent handling of pipetting aids, marking devices, and other items led to their contamination and further dissemination of HBsAg. An assay instrument for complete determinations of blood cell counts was observed to splatter and drip blood during its operation. The contamination rate for environmental surfaces associated with this instrument was 15%. The data indicate that transmission of HBV in the clinical laboratory is subtle and mainly via hand contact with contaminated items during the various steps of blood processing. These data support the concept that the portal of entry of HBV is through inapparent breaks in skin and mucous membranes.

Blood Specimen Collection

Computers in the clinical laboratory: what we have learned.

The clinical laboratory responds to a request for results by processing a specimen. The output is a report on a priority response. The role of the laboratory computer is that of a work allocation control system, which monitors and directs this intricate piecework activity. The operation is analogous to light industry. Effectiveness depends upon hardware reliability and internal laboratory control of the computer system.

Diagnosis, Computer-Assisted

Prospective applications of calorimetry in the clinical laboratory.

Calorimetric analysis depends on the direct proportionality between the heat changes that occur during chemical reactions and the amount of reacting substances. Potential uses of calorimetry in the clinical laboratory are discussed, with examples. The calorimetric technique does not require optically clear specimens, and if the specificity of the measured reaction is assured, calorimetry can be used for quantitative determinations of components that are present in a complex matrix system such as body fluids. Specific enzymic reactions have been used to measure substrates and enzyme activities in biological specimens calorimetrically, with precision, sensitivity, and accuracy comparable to routine photometric techniques. The application of calorimetry in the clinical laboratory is limited now by its slowness, but development of automated instruments may enable the technique to become competitive with conventional analytical techniques in the clinical laboratory.

Calorimetry

Establishing a multivariate clinical laboratory data base.

A regional or hospital-based "reference" value study is well within the range of every clinical laboratory. A program is described that samples one to two "health" subjects each working day under tightly controlled conditions. Sixty-seven variables are tested simultaneously to provide univariate age and sex ranges, and variance/covariance matrices from which associated correlation coefficients are obtained. This ongoing "reference" value program offers essential information for both univariate and multivariate interpretations along with validation and quality control for certain methods within the clinical laboratory.

Clinical Laboratory Techniques

A systematic procedure for selection of automated instruments in the clinical laboratory.

A five-step systematic procedure for comparison and selection of automated instruments for the clinical laboratory is presented. Thirteen criteria commonly used for selection of instruments in the clinical laboratory are discussed, and from these an opinion survey form is developed for use in decision making. A procedure for using this opinion survey form, tabulating the survey data, and making the final recommendation is also discussed.

Autoanalysis

[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

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

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