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The performance of autoclaves in 27 laboratories, operated in accordance with the normal routine of local practice, has been monitored using thermometric equipment. Sterilising performance was unsatisfactory on 10 of 62 occasions, and cooling was inadequate on 52 of 60 occasions.
This report examines logical but not yet widely recognized ramifications of the Clinical Laboratory Improvement Amendments of 1988 (CLIA'88), federal legislation that will require certification of all laboratories examining human specimens. Examination of the CLIA'88 committee reports and committee hearings suggest that more than the conventional approach to laboratory standards will be needed to meet the public's expectations as articulated by our elected representatives. The conventional approach to clinical testing standards seeks to assure quality by regulating the laboratory analytical process. However, little empirical evidence is available to support or refute this model, which has been used during the past 25 years. One alternative paradigm for laboratory standards is an approach that examines the total laboratory testing process, including the selection, ordering, and interpretation of the test as well as the laboratory analysis per se. The history of controversy over laboratory standards--especially personnel standards, the glacial federal regulatory rulemaking process, public expectations of fail-safe technology, among other factors--suggests the implementation of CLIA'88 will be a lengthy and vigorously debated contest. The risk of a test is seldom inherent in the test itself, but rather is a function of the context in which the test is being used to provide information for medical decision making. Our premise is that diagnostic tests must be examined in the context of the laboratory testing situation. We suggest that now is the appropriate time for laboratory professionals, practicing physicians, and the public to abandon conventional thinking regarding clinical laboratory standards. We believe that CLIA'88 reflects a shift in public expectations toward fail-safe laboratory testing and the need for additional government oversight in laboratory test quality. If these new expectations persist, CLIA'88 represents a potential landmark in the course of federal authority and the practice of medicine in the United States.
The National Reference Method Laboratory Network has initiated a program to certify clinical laboratory cholesterol measurement performance by using routine clinical specimens. Clinical laboratory and reference laboratory measurements of split samples are used to assess whether the clinical laboratory is meeting the Laboratory Standardization Panel's goals for accuracy and precision. We used a computer-based Monte Carlo simulation model of split-sample proficiency testing to evaluate the certification program and, in particular, to analyze the effects of reference laboratory bias and imprecision. Results of our simulations indicate that the accuracy of the certification program is strongly influenced by reference laboratory bias and less influenced by reference laboratory imprecision. The certification program is potentially highly accurate, but unless reference laboratory bias is tightly controlled, the number of classification errors may limit its utility. Moreover, the decision limit of the certification program needs to be higher than the Laboratory Standardization Panel's goal (3.5% instead of 3.0%) to ensure that an acceptably high proportion of well-performing clinical laboratories can become certified.
The requirements for Good Laboratory (GLP) and Good Clinical Practices (CGP) were established as a matter of urgency by the United States in the early 1970s. These were in response to gross misconduct and, in many instances, fraud. Over the next 15 years, a plethora of regulatory principles, guidelines, and regulations was produced by many countries of the world, culminating in single standards for European, Japanese, and United States authorities. Although with regard to GLP this has basically become a worldwide recognized standard within the preclinical (toxicology) studies, in the veterinary, chemical, agrochemical, and pharmaceutical industries, the GCPs are now seeing a rebirth. Within a clinical trials environment, there is most certainly a requirement for compliance with GCP, especially with regard to the harmonization of data within the European Community. The goal of this article is to cover the following aspects: Why should we have good practices? Why should laboratory data be audited? Why is there a need for a QA unit or function? What is the QA operational approach? How does a laboratory audit take place within laboratories? In discussing the laboratories and their subsequent data audits, the pitfalls and benefits are addressed and an examination of the data from the sponsor's viewpoint is compared with that produced by the laboratory. The types of laboratories present in a clinical environment are examined. They obviously comprise clinical pathology, microbiology, and analytical as well as ancillary hospital areas such as X-ray and cardiology. These laboratories may also be in the private sector, the National Health Service, contract laboratories, universities, or the general practitioner population.(ABSTRACT TRUNCATED AT 250 WORDS)
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A review of the origin of GLP (Good Laboratory Practice) and ISO (International Standard Organisation) directives is followed by a number of definitions of concepts such as quality, guarantees of quality, quality systems, etc. by laboratories (NEN 2653). These requirements are discussed in the paper. Certification is one of the guarantees of quality assessment by laboratories. Certification of laboratories is carried out by STERLAB (Laboratory Accreditation Board of The Netherlands) or the CCKL (National Coordination Committee for Quality Assurance for Health Care Laboratories in The Netherlands). In addition to certification, laboratories in the Netherlands are extremely active as regards external quality control (QC). QC is carried out by the various occupational groups. The paper finally closes with a discussion of future developments regarding quality control and certification in medical and veterinary diagnostic laboratories.
An understanding of horizontal and vertical integration and their quasi-integration variants is important for pathologists to formulate a competitive strategy for hospital clinical laboratories. These basic organizational concepts, in turn, are based on the need to establish control over critical laboratory inputs and outputs. The pathologist seeks greater control of mission-critical system inputs and outputs to increase the quality and efficiency of the laboratory operations. The LIS produces horizontal integration of the various hospital laboratories by integrating them vertically. Forward vertical quasi-integration of the laboratories is mediated primarily by the LIS through front-end valued-added features such as reporting of results and creating a long-term on-line test result archive. These features increase the value of the information product of pathology for clinicians and increase the cost of switching to another system. The LIS can also serve as a means for customizing the information product of the laboratories to appeal to new market segments such as hospital administrators.
Laboratory animal technology has evolved into a specialised field of expertise which is associated with the production, care and use of laboratory animals in biomedical teaching and research. A survey of laboratory animal facilities and supporting personnel was undertaken to assess the uses of laboratory animals in relation to the administrative and technical staffing of animal facilities. The results of this study indicate that there is a need for training in laboratory animal science at both the technical and professional levels. Options for the development of formal training in laboratory animal technology are reviewed.
Faced with constantly increasing costs for the provision of laboratory services to Medicaid recipients, the New York City Department of Health last year attempted to implement a program to fundamentally restructure the organizational patterns and financing mechanisms of New York City's clinical laboratory industry. The program, based on competitive bidding, gave one laboratory in each of New York's five boroughs exclusive rights to process Medicaid lab samples and replaced presently existing fee-for-service reimbursement mechanisms with a unique system combining unit pricing and capitation. This paper outlines the principal provisions of the City's proposed contract, analyzes the underlying motivations of the City's decision, and describes the reactions of the existing laboratory service delivery system. In addition, the generic problems of implementing effective administrative techniques for cost and quality control of laboratory services are discussed.
Through error and trials we have designed an ideal system for the clinical laboratory. Truly, it has been a very difficult task requiring our long-term experience working in the clinical laboratory. For example, if we purchase new examination equipment without any consideration or if we decide what type of equipment to introduce according to the common advice of the purchase committee of the hospital or the medical school, then we cannot design an ideal system of laboratory examinations and are forced to invest a large sum of money in vain. Moreover, the use of innumerable examination containers or test tubes which are disposable, can become a financial burden to the hospital. We have been trying to design a system of laboratory automation for more than ten years and have been successful in designing not only a specimen transport system using conveyer-belts but also various kinds of examination robotic systems. This report describes our own examples of designing a system of laboratory automation.
Laboratory certification does not offer concrete guarantees of consistent high quality of products or services. It does, however, identify, for the dental profession, a competency and acceptability factor on which to base a predication of performance by the laboratory. Also, laboratory certification establishes a framework within which the dental laboratory industry can work to continue upgrading its facilities and personnel, demonstrates the concern of certified laboratories for continuing competence, and indicates to government and third-party payers a willingness to develop standards endorsed by the industry.
Investigation of an outbreak of prolonged febrile illness in medical center personnel at the University of Rochester School of Medicine and Dentistry revealed lymphocytic choriomeningitis (LCM) virus to be the causative agent. Syrian or golden hamsters (Mesocricetus auratus) were found to be the only animals involved in maintaining the virus and were the source of human infections. Isolations of LCM virus were made from autopsy specimens of 13 of 46 (28%) golden hamsters. Virus isolations were made from 22 of 28 (79%) frozen specimens of 11 tumor lines transplanted repeatedly in golden hamster cheek pouches. No virus isolations were made from 86 autopsied laboratory mice, laboratory rats, Chinese hamsters (Cricetulus griseus), or laboratory rabbits or from 10 tumor cell lines transplanted in laboratory mice. Complement-fixation testing of 301 animal sera from the vivarium also revealed involvement primarily of golden hamsters. The probable source of virus introduction into the Rochester facilities was found to be two LCM-contaminated tumor lines sent from a biological supplier to Rochester in 1969.
The authors have carried out a survey of 23 bacteriology laboratories to investigate tuberculous contaminations which took place from 1967 to 1972 in these laboratories. They have reviewed 20 accidents in 74 technicians who performs searches for tuberculous bacilli, and 29 accidents in the total amount of 379 technicians working in these 23 laboratories. A comparison of these results with the previous published investigations shows a rather high number of cases reported in our country. A review of the possible causes of contaminations leads to suspect bacterial aerosols and to put forward the use of laminar flow enclosures as a prevention. The authors have tested several vertical flow instruments built to different patterns. All three convenient enclosures have an architectural characteristic: their blowing ceiling overhangs the working plane. As these instruments have been under examination for three years in a laboratory where contaminations are very likely to happen, they have obtained interesting results.
A survey of 117 member cardiac catheterization laboratories was undertaken by the Society for Cardiac Angiography and Interventions. The survey included numbers and types of procedures, both diagnostic and interventional, in adult as well as pediatric age groups. Radiation safety, various laboratory policies, frequency of short stay, and outpatient procedures were tabulated. Report generation, training programs, administrative organization, and laboratory equipment were all included. The results were compared with a 1978 survey. Areas of concern in terms of safety of the patient and possible underutilization of laboratories were identified.
Regulatory and reimbursement pressure on laboratory and hospital organizations have led to diversified or hybrid combinations of hospital inpatient, outpatient, and reference laboratory operations. Laboratory information system (LIS) requirements to integrate these operations become more complex than for either operation alone, because inpatient and reference operations have different and sometime conflicting priorities. Careful attention to LIS requirements is necessary to implement hybrid laboratory operations systems successfully.
The experience acquired by the Center for Diseases Control during the past 7 years in the administration of the Clinical Laboratories Improvement Act of 1967 suggests that the key indicators of reliability have been identified and that sensitive measurement of those indicators is now possible and practical. The costs of assuring high quality are inconsequential compared to the costs to the patient and taxpaying public of inaccurate test results. This objective system for evaluating clinical laboratories has been applied to licensed interstate laboratories and has been shown to be effective. This proven system has been offered to the Bureau of Health Insurance of the Social Security Administration for application to Medicare laboratories.
The competitors of hospital pathologists are commercial reference laboratories, hospital special function laboratories, pathology groups in neighboring hospitals, hospital mainframe computer personnel, and users of patient proximity testing systems. The laboratory information system can provide a strategic advantage over these competitors by matching, exceeding, or substituting for their capabilities and by creating switching costs for clinics, administrations, and patients. For example, the installation of microcomputers in clinicians' private offices provides them with ready access to the pathology data base, bonds them to the hospital, and capitalizes on the willingness of the hospital to invest in information technology.
Cultured lymphocytes from 73 workers in chemical laboratories and the printing industry were found to have a significantly increased frequency of chromatid and isochromatid breaks, in comparison with 49 control subjects (42 adults and 7 children). An increase of the same magnitude was also found in 14 children, aged 4 days--11 yr, of 11 women laboratory workers who had worked during pregnancy. A significant correlation between age and frequency of chromosome aberrations was noted for both the exposed and control children but not for the adults. The frequency of sister-chromomatid exchange was significantly increased in 12 technicians working in laboratories performing hormone analysis. 4 children of 2 female technicians working during pregnancy also had a significnatly increased frequency of sister-chromatid exchange. The cause and biological significance of these findings are not yet known.