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At least 1,747 records · Page 97Linked to original sources
PubMed1995

[Medical audit in laboratory medicine. A description of the course and some results].

All general practitioners of the Danish counties of Funen, Vejle and North Jutland were invited to participate in a medical audit concerning laboratory medicine organised by the Audit Project Odense (APO) in co-operation with the Consultative Arrangement for General Practice, emanating from the clinical/chemical departments of Funen. During three weeks the participants registered all clinical problems which would result in one or more laboratory tests. APO performed computer registrations and analyses of the results where upon each participant received a reply letter indicating the results of his own as well as the group's registrations. At a subsequent meeting the participants discussed the conception of "good general practice" as regards the use of laboratory medicine within defined clinical problems. The course of the audit demonstrated that the APO method is suitable for identification of a number of professional problems related to general practitioners' use of laboratory medicine and to reveal the variation in general practitioners' handling of laboratory medicine. Furthermore, the project showed that continuous quality development demands profound study of and research into the professional problems which the general practitioners encounter when using laboratory medicine.

Denmark↗
PubMedDate not supplied

[The pilot program in Mexican clinical laboratories. I. The characterization of structure and productivity].

OBJECTIVE: To validate a questionnaire which evaluates the structure of clinical laboratories and to obtain information on its productivity. PARTICIPANTS: A group of 18 laboratories belonging to hospitals of second (N = 15) and third (N = 3) levels of health care. Fifteen participants belong to the public sector and three are first rate private institutions. They are located in the metropolitan area of Mexico City comprising the Federal District (N = 12) and the State of Mexico (N = 6). METHODS: The questionnaire has 12 items which received a 0, 1/2 or 1 score. The maximum possible score for a perfect laboratory as well as for any question is 100. The questionnaire was filled during a visit to the participating hospitals by auditors of the agency of the Ministry of Health in charge of licensing laboratories at a national level. Information covering six months of work was obtained to calculate productivity using number of tests per worker per month. RESULTS: The global score of the 18 participants was 49. The private ones had the highest scores (79 to 96) which was to be expected as they were selected for their high technical and human resources. The five State laboratories had a score above the global mean, but only one of the Federal ones was in this situation. A high interlaboratory variability was observed, i.e. productivity in the highest rated was nine times larger than in the lowest rated. This finding suggests the presence of interlaboratory differences in the criteria used in the collection of productivity information. CONCLUSIONS: This short questionnaire can be used as a first approximation to identify structure deficiencies of the Mexican clinical laboratories.

Efficiency, Organizational↗
PubMed1994

Laboratory support for transplantation.

The clinical laboratory plays a major role in support of transplantation. Depending on the spectrum and number of transplants performed, such programs can consume up to 35% of all laboratory testing. This testing can be transplantation-nonspecific or -specific. The former constitutes routine laboratory procedures in various areas of laboratory medicine that are common to other categories of patients. Transplantation-specific testing includes tissue typing, procedures for assessment of graft viability/rejection, and measurement of immunosuppressive drugs. Because of the development of new immunosuppressive drugs such as FK506, cyclosporin G, and rapamycin, an increased burden will be placed on laboratories to establish new therapeutic monitoring programs. Preliminary guidelines for monitoring these drugs, similar to those previously established for cyclosporin A, are proposed herein. With the use of an increasing spectrum of immunosuppressive drug combinations, and the possible use of xenotransplantation on the horizon, new demands will be placed on the laboratory for the support of transplant programs.

Chemistry, Clinical↗
PubMed1994

Realistic modeling of clinical laboratory operation by computer simulation.

An important objective of laboratory management is to adjust the laboratory's capability to the needs of patients' care as well as economy. The consequences of management may be changes in laboratory organization, equipment, or personnel planning. At present only one's individual experience can be used for making such decisions. We have investigated whether the techniques of operations research could be transferred to a clinical laboratory and whether an adequate simulation model of the laboratory could be realized. First we listed and documented the system design and the process flow for each single laboratory request. These input data were linked by the simulation model (programming language SIMSCRIPT II.5). The output data (turnaround times, utilization rates, and analysis of queue length) were validated by comparison with the current performance data obtained by tracking specimen flow. Congruence of the data was excellent (within +/- 4%). In planning experiments we could study the consequences of changes in order entry, staffing, and equipment on turnaround times, utilization, and queue lengths. We conclude that simulation can be a valuable tool for better management decisions.

Chemistry, Clinical↗
PubMedDate not supplied

Costing of a salt iodine monitoring laboratory in India.

BACKGROUND: Iodine deficiency disorders (IDD) are an important public health problem in India and can be prevented by fortifying common salt with iodine. For the iodation programme to be effective, it is necessary to monitor the iodine content of salt. The National Iodine Deficiency Disorders Control Programme recommends that one salt iodine monitoring laboratory should be set up in each district. We calculated the cost of setting up such a laboratory in the year 1993. METHODS: We estimated that approximately 6000 samples of salt would be sent annually by health workers to the district laboratory as part of the routine report system. We calculated the capital cost of the laboratory to include land, buildings and equipment. The recurrent costs included salaries, chemicals and reagents, and maintenance assuming a uniform discount of 10%. RESULTS: A total of Rs 81,550 would be needed for one such laboratory annually, of which Rs 73,500 (89%) would be recurrent costs. This comes to Rs 13.60 per sample tested or 5 paise per head per year in a district with an average population of 1.7 million. If the building is already available and the staff in position only need to be trained, then Rs 16,040 per year (equipment, chemicals and operating costs) would be required. This comes to 1 paise per head per year. CONCLUSIONS: Setting up a salt iodine monitoring laboratory, a vital component for the salt iodation programme, has modest cost implications, especially if the building and staff already exist. This is likely to be the case in most of the districts.

Costs and Cost Analysis↗
PubMed1993

Laboratory experience and guidelines for avoiding false positive polymerase chain reaction results.

Despite the widespread use of polymerase chain reaction (PCR) for diagnosis of infectious diseases, the technology has not been generally introduced into routine diagnostic laboratories. One of the most serious problems which has influenced the acceptance of this technology is the occurrence of false positive PCR results. This study describes the experience, in a hospital laboratory setting, of using PCR for the diagnosis of heat-labile enterotoxin-producing E. coli, M. tuberculosis, M. paratuberculosis and human papillomavirus. Results indicate that a build-up of amplicons, generated during the amplification process in the laboratory, is the main source of PCR-contamination. Protocols are described that include both physical and chemical procedures to prevent contamination. The use of photo-induced psoralen is recommended for those laboratories already involved in PCR work where amplicons are likely to be present. An enzymatic system (uracil-N-glycosylase) was evaluated and is recommended for workers intending to start diagnostic PCR. Attention was given to simple control measures which are easily implemented in a routine diagnostic laboratory. Protocols such as these are likely to have a major impact on the introduction of PCR-based methods into routine laboratories.

Bacteria↗
PubMed1993

[The future of clinical laboratory medicine--a viewpoint from hospital administration].

Net profits estimated from the operation of about 10,000 public and private hospitals here in Japan, showed a 0.6 per cent decrease in 1991. This reflects the severity of hospital management under governmental policy requiring the rate of increase in medical expenses to be less than the rate of increase for the GNP. Changes in medical fee reimbursement in the National Health Insurance in April 1992, reduced the fees for many medical tests, resulting in decreased income especially in outpatient clinics. Because of this, it is necessary to review the maintainance or existence of hospital laboratories from the standpoint of medical needs and cost efficiency. Laboratory tests must be done promptly, even on holidays. Only hospital laboratories can do this. Many bedside tests will need to be instituted. Doctors preferably, or technicians should fully explain the need for tests to the patient. "Informed consent" is important. Test results should be reported to the doctors not only with the test data, but also with interpretation by clinical pathologists to expedite the doctor's decision or diagnosis. The need for commercial laboratories is increasing because of difficulty caused by new and expensive equipment and techniques of modern laboratory service even in large hospitals. Commercial laboratories should serve not only as a subcontractor, but also as symbiotic partner of hospitals, clinics or medical offices in both medical and business management.

Clinical Laboratory Techniques↗
PubMed1993

[Quality of sputum microscopy in the network of tuberculosis bacteriology laboratories in Colombia].

The objective of this study was to evaluate the technical quality of sputum microscopy carried out for diagnostic purposes in the Network of Tuberculosis Bacteriology Laboratories in Colombia. The National Central Reference Laboratory received 6,529 slides for reexamination from the network of 513 sectional, regional, and local laboratories, which contributed 33.2%, 27.6%, and 39.2%, respectively, of the slides. These included all the positive (3,283) and negative (3,246) smears processed during a 4-month period. The reexamination was carried out by six laboratory workers who did not know the origin of the slides or the original diagnosis. When qualitative problems were detected, a second reexamination was done, which significantly increased the percentage of agreement for both the positive results (93.9%) and the negative (98.7%). Overall, the level of agreement was 96.3%. A significant correlation was found (P < 0.05) between good slide preparation and staining and agreement in the readings, as well as between thin smears, presence of fuchsin precipitates, and deficient coloration and conflicting readings (P < 0.05). The highest percentages of agreement were associated with laboratories that performed the largest number of sputum examinations each month (96.5%), and with readings done by experienced, university-trained bacteriologists (96.6%). It is concluded that indirect technical supervision and ongoing training of laboratory personnel are important determinants of the impact of the tuberculosis control program.

Bacteriology↗
PubMed1993

A quality manual for the clinical laboratory including the elements of a quality system. Proposed guidelines.

Development of quality manuals is a means for the promotion of quality in clinical laboratories by describing the total quality system. It also provides opportunity of checking whether the quality system is implemented in reality and demonstrates to the hospital administration and the clinicians that the laboratory is committed to quality. The intention of these guidelines is to describe the elements of the quality system for a large clinical laboratory, and to present such a system in the form of a quality manual. The proposed guidelines comply, where relevant, with ISO/IEC guide 25 'General requirements for the technical competence of testing laboratories' and EN 45001 'General criteria for the operation of testing laboratories'. The document may be used as an aid for laboratories wishing to be accredited according to EN 45001, or intending to apply for formal certification of their quality systems, according to ISO 9001 'Quality systems--Model for quality assurance in design/development, production, installation, and servicing' utilizing ISO 9004 'Quality management and quality system elements--guidelines; Part 2 Guidelines for service'. However, information about the minimum requirements for official recognition should be obtained from the particular accreditation or certification body concerned.

Chemistry, Clinical↗
PubMed1993

Matrix effects on proficiency testing materials. Impact on accuracy of cholesterol measurement in laboratories in the nation's largest hospital system.

The objective of this collaborative study with the Department of Veterans Affairs (VA), College of American Pathologists (CAP), and the Centers for Disease Control and Prevention (CDC) was to quantitate the matrix-induced biases of cholesterol measurements on the CAP Comprehensive Chemistry Surveys materials used in proficiency testing (PT). A total of 174 VA Medical Centers outpatient clinics and clinical laboratories participate in the VA-CDC National Cholesterol Standardization and Certification Program. This study was conducted in 112 VA laboratories that have been standardized for measuring cholesterol accurately (within +/- 3.0% of the CDC reference-method values) using fresh, unfrozen, unadulterated human serum samples. Fresh serum samples and 1990 CAP Surveys materials were sent by overnight mail, and the laboratories were asked to analyze them simultaneously in triplicate in a single analytic batch run. The results showed significant matrix-effect biases with the CAP Surveys materials with six of the eight major peer groups, despite the fact that accuracy of cholesterol measurements was maintained with fresh serum samples. The magnitude and direction (positive or negative) of the matrix-effect biases were instrument, reagent, and method specific using the following peer groups: du Pont Dimension (-8.9%); Beckman CX4, CX5, and CX7 (-5.5%); Kodak Ektachem 400, 500, and 700 (+4.4%); Instrumentation Laboratory Monarch (-3.1%); Baxter Paramax (-2.4%); Technicon SMAC and RA (+1.3%); Hitachi/BMD 704 through 747 (+0.4%); and Abbott Spectrum (-0.3%). The CAP PT materials used currently do not behave in a manner identical to fresh human serum when measuring cholesterol on many, but not all, analytic systems. The observed biases due to "matrix effects" with PT materials will cause incorrect conclusions about the accuracy of many laboratory procedures performed on fresh patient specimens. This matrix-effect phenomenon will severely hamper interlaboratory accuracy transfer, standardization efforts, and monitoring performance of a laboratory's testing accuracy with the use of the current survey materials used in PT programs. Collaborative efforts are needed to (1) improve PT fluids to analytically behave more like fresh, human serum; (2) improve instrument design and reagent formulation; and (3) select methods and methodologic parameters that are more "robust" and less sensitive to the exact character of processed calibrators, quality control, and PT materials.

Bias↗
PubMed1995

Crime laboratory proficiency testing results, 1978-1991, II: Resolving questions of common origin.

A preceding article has examined the origins of crime laboratory proficiency testing and the performance of laboratories in the identification and classification of common types of physical evidence. Part II reviews laboratory proficiency in determining if two or more evidence samples shared a common source. Parts I and II together review the results of 175 separate tests issued to crime laboratories over the period 1978 to 1991. Laboratories perform best in determining the origin of finger and palm prints, metals, firearms (bullets and catridge cases), and footwear. Laboratories have moderate success in determining the source of bloodstains, questioned documents, toolmarks, and hair. A final category is of greater concern and includes those evidence categories where 10% or more of results disagree with manufacturers regarding the source of samples. This latter group includes paint, glass, fibers, and body fluid mixtures. The article concludes with a comparison of current findings with earlier LEAA study results, and a discussion of judicial and policy implications.

Body Fluids↗
PubMed1995

[Laboratory systematization].

We have built a clinical laboratory system incorporating automatic analyzers (chemistry, immunology and hematology) and automatic sample dispensers. This laboratory system is linked with a main computer through communication lines. Patient's serum specimens are first treated with an automatic sample dispenser and then analyzed at random with automatic analyzers. Specimens which need to be analyzed in commercial laboratories can be dispensed with another automatic sample dispenser. Consequently, cost of reagents and overtime payment can be reduced. Security for avoiding infectious diseases is provided for laboratory technicians. Our clinical laboratory system can reduce the turnaround time for reporting diagnostic data to 30 to 40 minutes. Also, this system can reduce personnel expenses. However, the profits are still not satisfactory compared with those of commercial laboratories. Therefore, we will continue to make every effort to cut down the expenses for the future.

Automation↗
PubMed1996

The challenge of managing laboratory information in a managed care environment.

This article considers some of the major changes that are occurring in pathology and pathology informatics in response to the shift to managed care in the United States. To better understand the relationship between information management in clinical laboratories and managed care, a typology of integrated delivery systems is presented. Following this is a discussion of the evolutionary trajectory for the computer networks that serve these large consolidated healthcare delivery organizations. The most complex of these computer networks is a community health information network. Participation in the planning and deployment of community health information networks will be important for pathologists because information management within pathology will be inexorably integrated into the larger effort by integrated delivery systems to share clinical, financial, and administrative data on a regional basis. Finally, four laboratory information management challenges under managed care are discussed, accompanied by possible approaches to each of them. The challenges presented are (1) organizational integration of departmental information systems such as the laboratory information system; (2) weakening of the best-of-breed approach to laboratory information system selection; (3) the shift away from the centralized laboratory paradigm; and (4) the development of rule-based systems to monitor and control laboratory utilization.

Community Networks↗
PubMed1996

Mycobacterial testing in clinical laboratories that participate in the College of American Pathologists Mycobacteriology Surveys. Changes in practices based on responses to 1992, 1993, and 1995 questionnaires.

OBJECTIVE: To determine whether the trend of increasing use of rapid methods of mycobacterial testing among participants in the College of American Pathologists (CAP) Mycobacteriology E Proficiency Testing Survey noted between 1992 and 1993 continued through 1995, and to collect information concerning mycobacterial staining and culture protocols from laboratories that do limited mycobacterial testing. METHODS: The 1993 CAP E Survey questionnaire addressing mycobacterial laboratory practices, test volumes, and rate of recovery of drug-resistant Mycobacterium tuberculosis was included with the CAP 1995 E-A Survey. A shortened list of these same questions, excluding those addressing mycobacterial identification and susceptibility test methods, was added to the CAP 1995 E1-A Survey, to which laboratories that do limited mycobacterial testing subscribe. RESULTS: A total of 802 and 1490 participants in the E and E1 surveys, respectively, returned responses to the CAP by the cutoff date for data analysis. For E Survey participants who answered questions concerning test methods in the years being compared, the percentage who used rapid techniques increased significantly over the study period. More participants used the fluorochrome stain (58% in 1992, 62% in 1993, and 72% in 1995), BACTEC TB plus a solid medium for culture (36% in 1992, 42% in 1993, and 50% in 1995), DNA probes for identification of M tuberculosis (68% in 1993, 79% in 1995), and BACTEC TB for susceptibility testing (65% in 1993, 71% in 1995). The percentages of E1 Survey participants who used a fluorochrome stain for detection of acid-fast bacilli and both a liquid and a solid medium for mycobacterial culture were lower than the percentages of E Survey participants who used these methods. Among participants who responded in all years being compared, the percentage processing respiratory specimens at least 7 times per week increased from 26% in 1992 to 30% in 1993 and 43% in 1995 (P < .001), and the percentages reporting an identification of M tuberculosis within 21 days and susceptibility test results within 28 days increased significantly over the study period (29% in 1992, 40% in 1993, and 56% in 1995 for identification; 13% in 1992, 19% in 1993, and 30% in 1995 for susceptibility testing). Turnaround times for E Survey participants were significantly shorter than those for E1 Survey participants. The number of specimens tested per month appeared to remain relatively stable between 1993 and 1995; however, the number of new patients with tuberculosis and the number of known tuberculosis patients with positive cultures declined significantly. CONCLUSIONS: The recent emphasis placed on utilization of rapid methods of mycobacterial testing appears to have influenced laboratories that subscribe to the CAP E Survey. Significantly more of these laboratories were following the Centers for Disease Control and Prevention's recommendations in 1995 than in 1993 and 1992. However, many laboratories that provide only limited mycobacterial testing still have not adopted the more rapid techniques. Because tuberculosis remains a public health problem, the efforts directed at its control must not wane if the recent downward trend in incidence is to be maintained.

Bacteriological Techniques↗
PubMed1996

Why is the laboratory an afterthought for managed care organizations?

Market forces have dramatically influenced the environment in which healthcare is delivered, but these changes do not need to be interpreted negatively by community laboratorians. Only total vertical integration of laboratory medicine can control episode-of-care cost. Opportunities also exist for horizontal integration with community partners to provide geographical coverage and to compete favorably for managed care contracts. Lowering cost through "economies of scale" may apply to the procurement of supplies and equipment, but the delivery of services must be considered in the context of their overall effect on episode-of-care cost. Laboratory services may make up 5% of a hospital's budget but leverage 60-70% of all critical decision-making such as admittance, discharge, and medication. Laboratory outreach can help the medical center's financial stability by: (a) providing tests and service that can reduce or avoid a hospital stay; (b) using the additional volume of testing to distribute existing fixed costs and lower unit cost; and (c) adding revenue as a direct contribution to margin. To successfully compete for contracted managed care services, the laboratory must network with other providers to demonstrate comprehensive access and capacity. Community hospital laboratories perform 50% of all laboratory tests in this country and have adequate excess capacity to fulfill the remaining community needs.

Health Care Costs↗
PubMed1996

Experiences with extended-duration medical laboratory support in deployable medical systems.

Medical laboratory services in an echelon-II Deployable Medical Systems environment were examined after a 6-month deployment in Guatemala-Fuertes Caminos 94 (N). The limitations in preparing and executing laboratory operations by U.S. Army Reserve units using Minimal Essential Equipment for Training components were identified. Corrective actions for planning future operations requiring laboratory support were addressed. Despite significant limitations, 353 laboratory procedures were conducted to standard. Additionally, laboratory procedures supporting blood-transfusion activities was successfully undertaken. Employment of laboratory services in remote environments for extended durations requires special attention and complete planning to ensure that all elements of care are in place to support medical operations.

Blood Banks↗
PubMed1996

Quality assurance in the mycobacteriology laboratory. Quality control, quality improvement, and proficiency testing.

In conclusion, the components of QA (QC, QI, and PT) in the mycobacteriology laboratory address not only the accuracy of testing but also provide a measure for the laboratory practices that are necessary to effectively diagnose and control tuberculosis in the community. Given the extremely important role of laboratory testing in the control of tuberculosis, providing rapid diagnosis and determination of susceptibility test results, laboratories should use the recommendations concerning turnaround times as either achievable goals or a measure of whether the laboratory should be performing mycobacteriology tests. We strongly urge laboratories to include their turnaround times for test results and the timeliness of reporting those results in their annual QA program.

Bacteriology↗
PubMed1995

Components of laboratory accreditation.

Accreditation or certification is a recognition given to an operation or product that has been evaluated against a standard; be it regulatory or voluntary. The purpose of accreditation is to provide the consumer with a level of confidence in the quality of operation (process) and the product of an organization. Environmental Protection Agency/OCM has proposed the development of an accreditation program under National Environmental Laboratory Accreditation Program for Good Laboratory Practice (GLP) laboratories as a supplement to the current program. This proposal was the result of the Inspector General Office reports that identified weaknesses in the current operation. Several accreditation programs can be evaluated and common components identified when proposing a structure for accrediting a GLP system. An understanding of these components is useful in building that structure. Internationally accepted accreditation programs provide a template for building a U.S. GLP accreditation program. This presentation will discuss the traditional structure of accreditation as presented in the Organization of Economic Cooperative Development/GLP program, ISO-9000 Accreditation and ISO/IEC Guide 25 Standard, and the Canadian Association for Environmental Analytical Laboratories, which has a biological component. Most accreditation programs are managed by a recognized third party, either privately or with government oversight. Common components often include a formal review of required credentials to evaluate organizational structure, a site visit to evaluate the facility, and a performance evaluation to assess technical competence. Laboratory performance is measured against written standards and scored. A formal report is then sent to the laboratory indicating accreditation status. Usually, there is a scheduled reevaluation built into the program. Fee structures vary considerably and will need to be examined closely when building a GLP program.

Accreditation↗