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PubMedDate not supplied

Antibody testing in Lyme disease. A comparison of results in four laboratories.

To evaluate the interlaboratory and intralaboratory agreement in the performance of Lyme disease serological testing, we sent serum specimens from 132 outdoor workers in New Jersey to as many as four independent laboratories. These included one state department of health laboratory, one large commercial laboratory, and two research laboratories. The measurement of agreement employed, the kappa statistic, ranged from .45 to .53 among the four laboratories and from .50 to .54 within the commercial laboratory. These values represent low levels of agreement. The data suggest that Lyme disease serological testing procedures should be standardized so that Lyme disease test results are more comparable between laboratories.

Antibodies, Bacterial↗
PubMed1986

Laboratory test analysis near the patient. Opportunities for improved clinical diagnosis and management.

New developments in laboratory technology have produced complex analytic systems that are simple to operate, relatively reliable, and inexpensive. These systems allow the office practitioner to perform test analyses in an office laboratory and can provide timely information useful for diagnostic and clinical management decisions. This article reviews the clinical applications and analytic systems available for use in urine analysis, blood cell analysis, determination of the sedimentation rate, coagulation testing, biochemical analysis, and bacteriologic and virologic testing. Although these analytic systems are generally designed to be used by nonprofessional laboratory staff, there is only limited information available about their reliability when used in this manner. Physicians, in bringing this technology into their office laboratories, must be cognizant of a new area of medical practice because they will now be the professionals responsible for the laboratory's function. It will be important that they develop new skills as the office laboratory directors and develop consultative relationships with laboratory professionals to ensure that the information used in patient care is both timely and reliable.

Bacteriological Techniques↗
PubMed1986

Quality control in the office laboratory.

Assuring quality of testing is as important in the doctor's office laboratory as it is in the hospital and independent laboratory. However, the office laboratory's problems and needs are different from those of the larger lab, and the professional laboratorian's solutions are not always appropriate for the office laboratory. It is necessary to recognize that the education and skill levels of the office laboratory staff preclude some of the quality control methods used in professionally staffed laboratories. For some test systems, new control methods will need to be developed. The professional laboratorian can provide valuable assistance to the doctor's office laboratory in assuring quality.

Laboratories↗
PubMed1985

A model for the statistical description of analytical errors occurring in clinical chemical laboratories with time.

The main purpose of the present study was to describe the statistical behaviour of daily analytical errors in the dimensions of place and time, providing a statistical basis for realistic estimates of the analytical error, and hence allowing the importance of the error and the relative contributions of its different sources to be re-evaluated. The observation material consists of creatinine and glucose results for control sera measured in daily routine quality control in five laboratories for a period of one year. The observation data were processed and computed by means of an automated data processing system. Graphic representations of time series of daily observations, as well as their means and dispersion limits when grouped over various time intervals, were investigated. For partition of the total variation several two-way analyses of variance were done with laboratory and various time classifications as factors. Pooled sets of observations were tested for normality of distribution and for consistency of variances, and the distribution characteristics of error variation in different categories of place and time were compared. Errors were found from the time series to vary typically between days. Due to irregular fluctuations in general and particular seasonal effects in creatinine, stable estimates of means or of dispersions for errors in individual laboratories could not be easily obtained over short periods of time but only from data sets pooled over long intervals (preferably at least one year). Pooled estimates of proportions of intralaboratory variation were relatively low (less than 33%) when the variation was pooled within days. However, when the variation was pooled over longer intervals this proportion increased considerably, even to a maximum of 89-98% (95-98% in each method category) when an outlying laboratory in glucose was omitted, with a concomitant decrease in the interaction component (representing laboratory-dependent variation with time). This indicates that a substantial part of the variation comes from intralaboratory variation with time rather than from constant interlaboratory differences. Normality and consistency of statistical distributions were best achieved in the long-term intralaboratory sets of the data, under which conditions the statistical estimates of error variability were also most characteristic of the individual laboratories rather than necessarily being similar to one another. Mixing of data from different laboratories may give heterogeneous and nonparametric distributions and hence is not advisable.(ABSTRACT TRUNCATED AT 400 WORDS)

Analysis of Variance↗
PubMed1985

Cost-effective use of laboratory tests: a joint responsibility of clinicians and laboratorians.

The successful attempts to achieve cost savings through improving the effectiveness of test utilization have several things in common. First, if the laboratory is to improve test ordering, it must thoroughly understand the clinical questions behind the test requests. Working with the appropriate clinical experts, the laboratory must establish standards and guidelines for appropriate test use. Then procedures must be developed to review and monitor test utilization to determine compliance with the standards and guidelines. Cost-effective improvements in the use of laboratory tests may require modifying clinicians' test ordering behavior through strategies such as problem-oriented request forms and administrative policy changes, but also the clinical laboratory's testing procedures where appropriate. Because laboratory tests are important elements of medical practice, the cost-effective use of laboratory tests and services is clearly the joint responsibility of clinicians and the clinical laboratory.

Clinical Laboratory Techniques↗
PubMed1983

External quality assessment for clinical microbiological laboratories in Norway 1982. 1. Evaluation of the identifications of 24 bacterial strains.

The first general external quality assessment (EQA) for clinical microbiological laboratories in Norway was carried out in 1982. Fifteen of 16 county and regional laboratories participated. Twenty-four pure cultures of different bacterial species were distributed by post. The distribution was "open" in the sense that the participants were aware of the cultures being part of the assessment. The strains had to be treated as routine clinical specimens. The bacterial identifications, the identification methods and the antibiotic sensitivity pattern had to be reported. The mean number of erroneous identifications was 2.7 (11.3%). Eleven strains were correctly identified by all laboratories, whereas four strains were misidentified by four to seven laboratories, accounting for approximately 50% of all misidentifications. All laboratories used "rapid" biochemical methods when identifying Gram-negative rods, mainly the "Three-tube method" and API 20E. Five laboratories used only one method, 10 used a combination of two or three methods. The use of more than one method did not give any substantial advantage. The accuracy of the "rapid" biochemical methods was approximately 88%, contrasting to approximately 96-98% when scientifically evaluated. The necessity of developing a permanent EQA scheme for microbiological laboratories is emphasized and a possible design for this is discussed.

Bacteria↗
PubMed1980

Laboratory staff development practices: a statewide study.

A statewide survey of staff development practices in New York State was completed to: 1) assess the current staff development practices for laboratory personnel in a variety of health care delivery settings; 2) determine the importance of selected laboratory practices to the professional growth of the laboratory staff; 3) make recommendations for staff development practices based on research findings. The study results are based on responses to a 1978 mail survey to laboratory staff employed in New York State. The most significant findings were that in over half of the laboratory settings surveyed three of six general types of laboratory staff development practices were nonexistent. Furthermore, regardless of size and/or type of laboratory setting, there were rare opportunities for staff development. The findings have implications for level of job satisfaction, level of professionalism, and even performance appraisal.

Humans↗
PubMed1980

Laboratory test selection.

One of the most frequent and perhaps frustrating problems in laboratory medicine today relates to the appropriate selection of laboratory tests. We all know that many laboratory tests are not always selected with care and results are not used to benefit the patient. If unnecessary tests are performed, then the laboratory is providing little or no new information to the clinician. This is costly and time consuming for the laboratory and wasteful of health care resources. In addition, unnecessary tests will serve to complicate the diagnostic process and adversely affect medical decision making. While precision and accuracy have been long standing concerns for the laboratorian, it is clear that our perspective about the tests we perform must be broadened if we are going to keep up with the changing pace of health care. The selection, interpretation and evaluation of laboratory tests can be facilitated by the use of some newer concepts in laboratory medicine They include sensitivity, specificity and predictive value. These concepts will be introduced together with examples of their application.

Analysis of Variance↗
PubMed1995

[Does a neurologic clinic need an inhouse cerebrospinal fluid/neurochemical laboratory? Results of a survey of 289 neurological clinics].

In 1993 and 1994 an official inquiry was carried out by the Deutsche Gesellschaft für Neurologie into the existence of neurochemical laboratories in departments of neurology throughout Germany. The following results were obtained. Neurochemical laboratories are more often seen in neurology departments involved in routine or emergency diagnosis than in departments engaged only in rehabilitation. Nearly all departments with an intensive care unit in a university hospital (91%) and nearly half of those outside the university (46%) have their own neurochemical laboratory. Departments with their own neurochemical laboratories are characterized by the use of specialized immunological diagnosis, especially of the cerebrospinal fluid (e.g., immunoglobulins, isoelectric focusing), in contrast to departments that are not working in the field of emergency medicine and are not equipped with their own neurochemical laboratories. The latter mostly carry out screening tests (e.g., antiepileptic drug monitoring, tumor markers). The existence of a neurochemical laboratory in a neurology department does not lead to an undifferentiated increase in the number of laboratory tests, but reflects the need for specialized diagnosis in CSF and neuroimmunology.

Brain Chemistry↗
PubMed1995

[Reducing unnecessary laboratory use through education and regulation].

Elimination of unnecessary laboratory use is becoming more and more important in the control of the rapid growth of medical costs in Japan. Among several measures to reduce unnecessary laboratory use, advising doctors about rational use of clinical laboratory is effective but not sufficient. At Tokyo University Hospital we have established a system to reduce unnecessary laboratory use. In this system warning about excessive use of laboratory tests appears on the display when a doctor orders more laboratory tests by the console than the maximum number of tests covered by health insurance. With this warning system we can effectively minimize unnecessary use of laboratory tests.

Clinical Laboratory Techniques↗
PubMed1994

The OECD policy for the implementation of the principles of good laboratory practice.

OECD has been involved in the harmonisation of policies and instruments for chemicals control since the late 1970's. The OECD principles of good laboratory practice (GLP) were developed and subsequently adopted by the Council in 1981. These principles have the primary objective of ensuring the generation of high quality test data. They set out managerial concepts covering the organisation of test laboratories as well as the conditions under which laboratory studies are planned, performed, monitored, recorded and reported. A system of compliance monitoring procedures has been established to ensure that laboratory studies are carried out in member countries according to the principles of GLP. The harmonization and mutual recognition of compliance monitoring methods among member countries have been a crucial step in ensuring the international acceptability of data. This undertaking involved the development of consistent criteria for determining whether a laboratory conducts studies in accordance with the principles of GLP. Training courses are held for GLP inspectors, an activity which lies at the basis of harmonising monitoring procedures. Consensus workshops result in consensus documents on the harmonised application and interpretation of the GLP principles in specific areas or on specific points. This system makes it possible for countries to speak the same language when exchanging information about specific laboratories, and to have confidence in the quality and rigour of safety tests undertaken in a laboratory.

International Agencies↗
PubMedDate not supplied

[The pilot program in Mexican clinical laboratories. II. The characterization of the operating processes].

OBJECTIVE: To evaluate a questionnaire for operating procedures in Mexican clinical laboratories. PARTICIPANTS: A group of 18 hospital laboratories (described in the first paper of this series). METHODS: The questionnaire had 132 items exploring nine sections (bacteriology, clinical chemistry, general hematology, immunology, microbacteriology, mycology, parasitology and urine analysis) and it was filled by the participants and modified if necessary in an audit visit. The questions were scored in the range of zero to one, and the participants in a scale of zero to 100 points. RESULTS: the answers had scores ranging from zero (N = 3) to one (N = 11) and a distribution with a clear shift to high scores. This led to a partition in three categories (low: < 0.3, medium: 03.-0.7, high: > 0.7) and to calculate a low/high ratio which enabled us to identify poor procedures in the sections. This ratio was also used to evaluate the type of procedure involved, i.e. management (N = 51), resources (N = 36), quality control (N = 23), and type and number of tests performed (N = 16). In the evaluation of the laboratories, the global score was 60. As expected, the private laboratories had the highest scores (73 to 84) as they were chosen because of their good resources. In the public ones only the State laboratories had more members above the mean score than below, whereas most of the Federal laboratories were below the global mean. CONCLUSIONS: The questionnaire performed reasonably well in spite of some deficiencies, i.e. it should include more questions on the specialized sections and on procedures other than management. The specialized sections (immunology, microbacteriology, mycology and parasitology) had lower scores than the more traditional ones (chemistry, hematology and bacteriology). Resources and quality control had lower scores than management; and the laboratory scores of the auditors tended to be lower than the autoevaluation of the public hospitals.

Laboratories, Hospital↗
PubMed1994

The clinical immunology laboratory of the future.

The clinical immunology laboratory assumes the responsibility of providing a complete array of analytical measurements for the diagnosis and management of patients with dysfunction of the humoral (antibody, complement) and cellular (T/B cells, phagocyte) immune system. To identify trends in the activities of the clinical immunology laboratory of the future, I first define the current status of the clinical/diagnostic immunology laboratory, examining six aspects: scope of work, analyte groups, assay methods, specimen types, instrumentation, and standardization. The scope of the clinical immunology laboratory's testing is expected to expand, with a trend toward consolidation of work into fewer, more well-equipped laboratories. An increase is expected in the total number of analytes examined as well as in the numbers of analyte groups and specificities. Assay methods will continue to improve in analytical and clinical sensitivity and specificity, with an emphasis toward less-complex procedures. The primary specimens evaluated will still be serum, urine, tissue, and cells, with a minor expansion into the use of other, less-accessible human body fluids. Instrumentation will move toward increased automation, with the concurrent development of "universal" automated immunoanalyzers for use in humoral and cellular immunology. Finally, standardization of immunological measurements with calibrated reference proteins and antibodies will promote interlaboratory agreement. I describe the diagnostic allergy laboratory to illustrate the immunology laboratory environment.

Allergy and Immunology↗
PubMed1993

Accidental fires in clinical laboratories.

The National Fire Protection Association, Quincy, Mass, estimates that 169 fires have occurred annually in health care, medical, and chemical laboratories. On the average, there are 13 civilian injuries and $1.5 million per year in direct property damage. Most fires in which the cause or ignition source can be identified originate in malfunctioning electrical equipment (41.6%) or in the facility's electrical distribution system (14.7%). The prevalence of fire safety deficiencies was measured in the College of American Pathologists Laboratory Accreditation Program. Of the 1732 inspected laboratories, 5.5% lacked records of electrical receptacle polarity and ground checks in the preceding year. Of these inspected laboratories, 4.7% had no or incomplete documentation of electrical safety checks on laboratory instruments. There was no evidence of quarterly fire exit drills in 9% of the laboratories. Deficiencies were also found in precautionary labeling (6.8%), in periodic review of safe work practices (4.2%), in the use of safety cans (3.7%), and in venting of flammable liquid storage areas (2.8%). Fire preparedness would be improved if all clinical laboratories had smoke detectors and automatic fire-extinguishing systems. In-service training courses in fire safety should be targeted to the needs of specific service areas.

Fires↗
PubMed1993

[Laboratory medicine, my philosophy and prospect].

I have been working in the field of laboratory medicine for 45 years including the period of working as a physician. During my career, some of my dreams in laboratory diagnosis have been realized, and some have not. Although the issues changed with time, our basic philosophy has not changed at all. In this session, I would like to discuss "my philosophy of laboratory medicine", that is, what I have intended and what I have done. First, I describe the role of laboratory medicine in the field of clinical medicine. Second, I discuss the value of laboratory tests especially for clinical diagnostics. Third, I summarize the history of clinical pathology with reflection of the past, and my anticipation for the future. Fourth, I mention about the task and responsibility of the laboratory technicians and clinical pathologists, in view of their common purpose, clinical diagnosis. Finally, I discuss the future aspect of laboratory medicine.

Clinical Laboratory Techniques↗
PubMed1995

Crime laboratory proficiency testing results, 1978-1991, I: Identification and classification of physical evidence.

The proficiency testing of crime laboratories began in the mid-1970s and presently assumes an important role in quality assurance programs within most forensic laboratories. This article reviews the origins and early results of this testing program and also examines the progress of proficiency testing in allied scientific fields. Beginning in 1978, a fee-based crime laboratory proficiency testing program was launched and has grown to its present level involving almost 400 laboratories worldwide. This is the first of two articles that review the objectives, limitations and results of this testing from 1978 through 1991. Part I reviews the success of laboratories in the identification and classification of common evidence types: controlled substances, flammables, explosives, fibers, bloodstains, and hairs. Laboratories enjoy a high degree of success in identifying drugs and classifying (typing) bloodstains. They are moderately successful in identifying flammables, explosives, and fibers. Animal hair identification and human hair body location results are troublesome. The second paper will review the proficiency of crime laboratories in determining if two or more evidentiary samples shared a common origin.

Animals↗
PubMed1995

Variability in leukocyte subset measurements among five laboratories in Vancouver.

Cell counts and percentages of CD4 are widely used in the prognostic and clinical management of HIV-infected patients, and as surrogate outcomes in clinical trials involving HIV-infected individuals. Considerable variability in CD4 counts has been documented due to physiologic and methodologic factors. While studies of variability of CD4 counts among American and French laboratories have been reported in the literature, no published data are available for Canadian laboratories. This paper describes the results of a study to determine the variability of leukocyte subsets among 5 laboratories in Vancouver, British Columbia. Samples were collected in a prospective fashion from 52 HIV-negative patients from July 1991 to November 1993. Coefficients of variation (CV) were calculated for leukocyte subset percentages and absolute cell counts among laboratories. Our results demonstrate that the variability in leukocyte subsets among 5 Vancouver laboratories was lower than or comparable with published findings. The variability remained stable over the time period of the study, although 4 of the 5 laboratories participated in quality assurance programs. This suggests a plateau in the impact of this program. Since the variability among laboratories is less than the variability attributable to physiologic factors, further research efforts to reduce this variability should focus on physiologic sources.

British Columbia↗
PubMed1995

[Evolution of the Mycobacteria Laboratory of the Pasteur Institute of Madagascar from 1991 to 1994].

In 1991, the Laboratory of Mycobacteria was a small laboratory, part of the Clinical Biology Centre (CBC) of the Institut Pasteur de Madagascar: 656 pathological samples have been analysed for the account of the CBC and the National Control Programme activities. Within 4 years, the number of samples tested increased by more than threefold and the technical ability has evolved in an important way, specially for the identification and the antibiotic sensitivity testing. The scientific equipment have been modernized and the rooms surface increased by fourfold. In 1995, this laboratory was officially designated as the National Reference Laboratory for the culture, the identification and antibiogramme for the account of the National Control programme and for the private clinicians. It also participates to the tuberculosis research programmes of Institut Pasteur de Madagascar. It is associated to the Laboratory of Mycobacteria in the Institut d'Hygiène Sociale of Antananarivo which is the National Reference Laboratory for the bacilloscopy, the teaching and the supervision of the peripheral laboratories.

Academies and Institutes↗