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PubMed1990

The College of American Pathologists Laboratory Accreditation Programme.

The Laboratory Accreditation Programme (LAP) offered by the College of American Pathologists (CAP) was begun in 1961. It is a voluntary peer review programme with the goal of laboratory improvement to excellence. It presently accredits more than 4300 laboratories throughout the world, although the majority are in the United States and Canada. Accreditation is contingent upon continuing successful performance in the CAP proficiency testing programmes, as well as passing biennial on-site laboratory inspections. These on-site inspections are done by practising laboratorians who use checklists appropriate for the various laboratory disciplines. Several governmental regulatory agencies (e.g. the Health Care Financing Agency) as well as private agencies (e.g. the Joint Commission on Accreditation of Healthcare Organizations) accept the LAP in place of their own programmes for laboratory accreditation.

Accreditation↗

PubMed1990

Industrial employee drug screening: a blind study of laboratory performance using commercially prepared controls.

Reference laboratories are an integral component of any industrial employee drug screening program. We evaluated the performance and accuracy of the reference laboratories used by Rockwell International, a large industrial employer with an active drug screening program. A total of 829 commercially prepared control samples containing drugs of abuse, over-the-counter drugs, and analytes found in the normal employee population were disguised as routine submissions to reference laboratories used by nine Rockwell facilities. Analyses of results included compilation of false-positive and false-negative errors per drug per laboratory and a correlation of errors with preliminary and confirmation methods. Error rates of 2% false-positive results and 20% false-negative results were found for all laboratories. The errors were not limited to any one technique nor to any particular drug. The error rates observed suggest the need for routine blind testing programs and increased interaction between industry and laboratories.

Animals↗

PubMedDate not supplied

Availability of laboratory testing services for identification of periodontal pathogens in dental plaque.

Microbiologic monitoring of key subgingival plaque organisms has been proposed to enhance management of some patients with destructive forms of periodontal disease. However, isolation and identification of many of these species is available only through selected microbiology laboratories possessing special expertise with periodontal microorganisms. The purpose of this study was to determine the availability of periodontal microbiology laboratory services in the U.S. and Canada that identify suspected periodontal pathogens for dentists in clinical practice. A survey questionnaire was mailed to all U.S. and Canadian dental schools. Six laboratories that process plaque samples for dentists in private clinical practice were identified. All of the testing services examine plaque specimens for Actinobacillus actinomycetemcomitans and Bacteroides gingivalis. Four of the laboratories used bacterial culturing to characterize a wide range of plaque species and to determine antibiotic sensitivity of isolates. Two other laboratories use indirect immunofluorescence microscopy or DNA probes to screen for three putative periodontal pathogens. All but one of the testing services analyze plaque samples that are collected by private practitioners in their offices and forwarded to the laboratory through next-day delivery services or regular mail. The availability of these adjunctive diagnostic services may enhance the ability of dentists in clinical practice to apply recent advances in knowledge on periodontal microbiology into routine preventive and therapeutic patient care.

Bacteria↗

PubMed1989

Evaluation of the performance of Italian laboratories in the determination of cadmium levels in blood.

The measurement of the blood cadmium level is necessary for the biological monitoring of workers or of general populations that are thought to be professionally or environmentally exposed to cadmium. However, since the levels of interest are exceedingly low, the analytical determinations involve considerable problems. With the aim of comparing the performances of the Italian laboratories in the blood cadmium levels determination, a working group of the Istituto Superiore di Sanità (Italian National Institute of Health) promoted in 1983 a quality control program including the provision of materials for the internal quality control and the performance of bi-monthly or quarterly exercises for the external quality control. The promoting laboratory provided the preparation and distribution of the samples to the laboratories and the processing of the data at the end of each exercise. A global and more thorough evaluation of the performances of each laboratory was carried out at the end of each phase (lasting at least one year), including a graphical evaluation of the results of each laboratory according to a predetermined acceptability criterion and the linear regression analysis. Of the 20 participating laboratories, approximately 50% obtained acceptable results for at least 80% of the examined samples. The mean relative inaccuracy decreased from 36% in the first phase to 20% in the last one. To improve analytical performances, both technologically advanced instrumentations and experienced personnel seem to be necessary.

Animals↗

PubMed1989

A regulatory model for clinical laboratories: an empirical evaluation.

Clinical laboratories in the United States are subject to various regulatory and accreditation programs, which mandate a broad range of requirements regarding personnel, quality-control systems, and analytical proficiency standards. Reported here, for a cross-section of U.S. laboratories, is the degree of compliance with these regulatory requirements, some other laboratory characteristics, and their relation to analytical proficiency. The results suggest that those laboratory characteristics that predict highest proficiency-test performance differ for each laboratory specialty. Regression models are presented that explain from 12% to 35% of the variation in analytical performance and suggest that factors outside of those specified in the regulatory model and other characteristics measured in this research are important. Indeed, the current regulatory approach may not ensure highest performance. Also discussed are the current status, limitations, and prospects for change of the clinical laboratory regulatory system.

Accreditation↗

PubMed1986

Differences between the nutritional reserves of laboratory-maintained and field-collected adult mosquitoes.

Individual female mosquitoes from field populations of Aedes aegypti, Culex nigripalpus and Coquillettidia perturbans were analyzed for sugar, glycogen and lipids. Controls were maintained in the laboratory for 7 to 10 days on 2% and either 10 or 20% sucrose. Mosquitoes held in the laboratory had significantly more glycogen and lipid than field-collected mosquitoes of the same species. Laboratory mosquitoes maintained on 10 or 20% sucrose contained more sugar than did field mosquitoes. Mosquitoes of the above species were collected at field sites in January, April, July and October and nutritional reserves were determined. Seasonal differences in reserves were documented in females of all species. However, even when reserves were at their highest in field-collected mosquitoes they rarely approached the reserves in mosquitoes of the same species maintained in the laboratory on 10 or 20% sucrose. Since laboratory-maintained mosquitoes are nutritionally different from those in the field, results of laboratory studies on flight performance, host attractancy, biting, disease transmission and oviposition behavior may be biased.

Animals↗

PubMed1989

Organization and operation of a flow cytometric immunophenotyping laboratory.

Technical advances in the field of flow cytometry have made it feasible for many academic and private hospital laboratories to purchase relatively inexpensive "user friendly" flow cytometers that do not require dedicated flow cytometer operators, special rooms, or a significant amount of laboratory space. Because the financial and physical constraints in operating a flow cytometer have been substantially reduced, many pathologists may now be considering such a purchase. By chronicling the clinical activities of a single flow cytometric immunophenotyping laboratory, this report will answer a variety of questions that may be asked by pathologists regarding both the utility of flow cytometers in clinical diagnosis and the mechanics of operating an immunophenotyping laboratory. The types of tissues that can be evaluated by flow cytometry will be detailed, and we will summarize the number and type of flow cytometric clinical studies performed in our laboratory since its development in 1983. Practical aspects of laboratory operation including technical staff requirements, specimen handling and processing procedures, monoclonal antibody selection, and quality control procedures will be presented. In addition, a comprehensive review of flow cytometric immunophenotyping studies as applied to the diagnosis of leukemias, lymphomas, and immunodeficiency disorders will be presented along with case examples that illustrate our approach to the interpretation of immunophenotyping results.

Adult↗

PubMed1988

[Laboratory diagnosis and practical treatment of patients].

The practical treatment of patients requires a reliable diagnosis and prognosis followed by therapy. Laboratory medicine is an essential scientific basis to rational treatment in each of these three phases. The significance, usefulness and extent of laboratory tests are largely dependent upon the disease spectrum. The possibilities and aims of laboratory medicine are: 1. Knowledge of and research into both the pathobiochemical and statistical connections between biochemical data and diseases leading to the selection of diagnostically reliable and relevant parameters. 2. Knowledge of the sensitivity, specificity and predictive values of relevant biochemical parameters and their application to the different clinical problems. 3. Evaluation of reliable analytical methods with details of their accuracy and precision. 4. Critical evaluation of pre-analytical factors. The translation of accurate laboratory data into clinically relevant information must always be coupled with a critical assessment of its diagnostic value, validity and range of error. An uncritical "consumption" of laboratory data is dangerous for both the patient and the clinician as is the suppression of these data when it does not fit the supposed diagnosis. Laboratory medicine is indispensible in proper patient care since it guarantees adequate medical action. The information that it delivers is binding and therefore offers help as well as protection.

Clinical Laboratory Techniques↗

PubMed1986

Error in laboratory reference limits as shown in a collaborative quality-assurance program.

Laboratories participate in collaborative quality-assurance programs to maintain and improve the quality of their diagnostic assays, but little attention has been paid to diagnostic quality in these programs. We used a national quality-assurance program to assess the quality of laboratory reference intervals as exemplified by triiodothyronine, thyroxin, and thyrotropin immunoassays. The limits of the reference intervals used by laboratories bear virtually no relationship to laboratory bias, i.e., whether assays read "high" or "low." Further, correcting assay results from different laboratories for the reference limits used increases rather than decreases interlaboratory scatter. We conclude that the analytical quality of immunoassays now exceeds the quality of the reference limits supplied to clinicians to assist diagnosis, and that nationally or internationally defined reference limits would therefore provide more information at less cost than do individual laboratory reference limits.

Humans↗

PubMed1986

Application of the EXPERT consultation system to accelerated laboratory testing and interpretation.

The EXPERT consultation system-building tool, a knowledge-based artificial intelligence program developed at Rutgers University, has been applied to the development of a laboratory consultation system facilitating sequential laboratory testing and interpretation. Depending on the results of a basic panel of laboratory tests, the system requests that specific secondary tests be performed. Input of these secondary findings can result in requests for tertiary testing, to complete the database necessary for interpretation. Interpretation of all results is based upon final inferences from the collected findings through a series of rules, a hierarchical network that yields an efficient production system not easily obtained through conventional programming. The rules included in this model are based upon initial results for total protein, calcium, glucose, total bilirubin, alkaline phosphatase, lactate dehydrogenase, aspartate aminotransferase, thyroxin, hemoglobin, mean corpuscular volume, and the concentrations of four drugs. Pertinent clinical history items included are jaundice, diabetes, thyroid disease, medications, and ethanol. Implementing this system in a laboratory-based accelerated testing program involving outpatients maximized the effective use of laboratory resources, eliminated useless testing, and provided the patient with low-cost laboratory information.

Adolescent↗

PubMed1978

The scope of a laboratory animal program needed at a veterinary school.

The discipline of laboratory animal medicine is one of the most rapidly expanding specialties within the veterinary profession. Veterinary schools should fully accept the responsibility for introductory instruction in laboratory animal medicine in the professional curriculum. Such instruction should articulate the varied opportunities that exist for the laboratory animal veterinarian within the biomedical research community, and provide an overview of the normal biological characteristics and pathologic conditions of the common laboratory animal species. In addition, the opportunity should exist within the veterinary school for graduate and undergraduate students utilizing experimental animals to receive a comprehensive introduction to laboratory animal biology, care, and management. Instructional responsibility for such courses should be accepted by faculty veterinarians with advanced training in laboratory animal medicine. Veterinarians with advanced training in this specialty are uniquely qualified to make substantial contributions to biomedical research by promoting the health and welfare of the research animal.

Animals↗

PubMed1986

Computers in clinical laboratory management in Singapore.

In 1974, an off-line mini-computer system was introduced in the Clinical Biochemistry Laboratories of the Government Department of Pathology in Singapore. With the resiting of the 24-hour emergency biochemistry laboratory on the same floor as the Haematology Department within the new Singapore General Hospital, an on-line computer system was installed in 1983 to serve both the emergency biochemistry and haematology laboratories. An almost identical on-line system was also purchased in 1984 to replace the aged off-line system at the Department of Pathology. A description of the new computer systems based on Eclipse S/140 computers and Medical Information Technology (Meditech) software using Meditech Interpretive Information System (MIIS) language will be given. The specific features required and the selection criteria for the on-line systems are also discussed. The systems are used for the acquisition and processing of all patient and test data of the laboratories, direct capture of data from automated instruments, generation of work schedules and laboratory reports, compilation of work done, workload and revenue statistics and a variety of other reports. Patient cumulative records and quality control statistics are available on a real-time basis, thus greatly facilitating enquiries on patient results and monitoring of analytical performance. Prior experience with an off-line system and careful planning have been helpful in greatly shortening the preparatory period required for the smooth implementation of the on-line systems. Use of the systems has significantly improved laboratory management and has resulted in improved quality, and higher efficiency and productivity.

Chemistry, Clinical↗

PubMed1985

Training appropriate laboratory workers for rural health centres in Papua New Guinea.

Many rural health centres in developing countries continue to treat patients without the help of any laboratory tests. The result is often inaccurate diagnosis, wasteful use of multiple drugs, and increasing drug resistance of pathogens. It is unlikely that there will ever be sufficient funds to employ a full-time laboratory worker at each of the many small remote health centres in Papua New Guinea. It is also doubtful whether staff and health extension officers who run such centres have the appropriate knowledge to adequately utilize full-time laboratory personnel. It is feasible, however, to train selected health workers in courses of three to four months' duration to perform a few simple laboratory tests part-time, in addition to their clinical duties. Suitable tests are those where the result does not require skilled interpretation. For most such tests, the result is the diagnosis. After the clinical staff have received the laboratory diagnosis, they are free to decide whether it fits the clinical picture. If so, they can then find the appropriate treatment to prescribe in standard treatment books. The present paper describes the experience in setting up and operating laboratory training for health centre staff in Milne Bay Province, Papua New Guinea. Costs and initial results of the program are discussed.

Allied Health Personnel↗

PubMed1985

Laboratory animal medicine. Changes and challenges.

Less than three decades have elapsed since the specialty of laboratory animal medicine was first formally recognized. Tremendous progress and maturation has occurred in this short time frame due in large part to the foresight of early pioneers in the field, attention to the moral and ethical use of animals, and the recognition by the biomedical research community of the indispensable role played by the laboratory animal medicine specialist in forging new knowledge in the biomedical sciences. The ability of laboratory animal medicine specialists to properly balance their efforts in collaborative and independent research, clinical services and teaching, offers exciting challenges and opportunities for veterinarians entering the specialty. Undoubtedly, another challenge to the specialty, currently and in the foreseeable future, is the debate over animal rights which began to ferment in the late 1970's, after lying relatively dorment since the 1950's. A growing number of Americans, including some scientists, contend that animals have inherent rights to a full life, free of intentional pain, even when done in legitimate scientific pursuits; some ardent anti-vivisectionists state that the use of animals in experimental research is immoral. The laboratory animal medicine specialist will have to effectively deal with the administrators of institutions using research animals, the attendant federal and state guidelines and laws regulating their use, and defend the use of laboratory animals to a polarized public, while at the same time ensure the humane care and use of animals under their purview. Certainly, the specialty is squarely placed in a hotly debated dilemma, fraught with ethical, moral, medical, philosophical, religious, and political complexities. I believe the specialty has the vision and maturity, and is indeed ready, to successfully meet that challenge - to assuage public concern, implement new federal policy regarding animal care and use, and maintain the excellent progress in laboratory animal medicine realized in the last 75 years.

Animals↗

PubMed1970

Clinical laboratory personnel: is there a shortage in California?

In a study of vacancy rates for laboratory personnel in California to determine if there is in fact a serious or critical shortage of qualified individuals in this group of allied health professionals, it was found that while the answer is still elusive, it would appear that although the shortage may be somewhat greater than normal it is not critical in most areas of the state. For most areas, the situation seems to have improved from 1966 to 1968. There are a few geographical areas, predominantly rural, where shortages of licensed personnel are critical. Vacancy rates also are higher in hospital laboratories. Recruitment difficulties in these situations may be related to insufficient incentives, including but not necessarily limited to salaries. Training in California laboratories may facilitate recruitment in specific instances, and may assume greater importance in the future as working conditions for health professionals continue to improve in other states. And finally, the use of laboratory assistants, aides, and clerks can materially assist the laboratory work, thereby freeing the licensed professional staff to accept responsibilities commensurate with the increasing sophistication of laboratory knowledge and practice.

California↗

PubMed1983

Comparing nonphysician and physician laboratory administrative responsibilities.

When the ASMT Board of Directors approved the conduct of a new laboratory management survey, they believed that the data from the survey would have value to the Society and its constituents. Indeed, it did. These data illustrated to federal health policy makers just how much of a role nonphysician clinical laboratory practitioners play in laboratory administration and day-to-day management. The results of this survey were extremely valuable to ASMT during recent federal regulatory and legal proceedings regarding the role of clinical laboratory scientists in laboratory services delivery and medicare payment policy for hospital clinical laboratory services.

Administrative Personnel↗

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↗

PubMed1995

Accuracy of laboratory and portable monitor international normalized ratio determinations. Comparison with a criterion standard.

BACKGROUND: Portable instruments that measure the prothrombin time and automatically calculate the international normalized ratio (INR) with the use of a drop of whole blood have simplified the treatment of patients who are receiving warfarin therapy. The accuracy of these portable monitors has never been determined by comparing INR results with a criterion (gold) standard INR determination. METHODS: Duplicate whole-blood INR determinations were made with two commercially available portable INR monitors. Duplicate frozen-plasma samples were measured with four different thromboplastin reagents, each with a different international sensitivity index. The criterion standard INR was determined by using an international reference thromboplastin and the manual tilt-tube technique. Agreement was evaluated by determining how accurately laboratory and monitor INR determinations matched criterion standard values in designating a sample to be within or outside of currently recommended INR target ranges. RESULTS: Two of the laboratory methods, which used relatively sensitive thromboplastins, showed close agreement with the criterion standard, whereas two laboratory methods that used less sensitive thromboplastin reagents showed poor agreement. Both of the portable monitors fell between these extremes. The two best laboratory methods ere significantly better (P < .003) than both monitors, which in turn were better (P < .003) than the remaining two laboratories. CONCLUSIONS: There is large interlaboratory variation in the accuracy of INR determinations. Laboratory methods that used insensitive (high international sensitivity index) thromboplastins performed poorly. Accuracy of monitor measurements appears satisfactory.

Adult↗