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Overview of the laboratory accreditation programme of the College of American Pathologists.

Although Saudi medical laboratories have developed enormously over the past 25 years, the absence of a national body for medical laboratory accreditation has meant the number of accredited laboratories (seven) remains low. Of these, five are accredited by the College of American Pathologists' Laboratory Accreditation Program (LAP)--the 'gold standard' of laboratory accreditation. It requires successful performance in the College of American Pathologists' proficiency testing programme as well as passing on-site inspections carried out by practising laboratory technicians, after which the laboratory is accredited for a 2-year period. This article gives an insight into the current situation of laboratory accreditation in Saudi Arabia and an updated overview of the process involved in obtaining laboratory accreditation from the College of American Pathologists.

Accreditation↗

The role of the laboratory in the prevention and detection of chronic disease.

Laboratory Initiative For The Year 2000 (LIFT), the laboratory response to the Healthy People 2000 program, includes the following in its definition of chronic disease: cancer, diabetes, hypertension, end-stage renal disease, stroke, and cardiovascular disease. All are priority health targets for which the laboratory must play an active support role if we are to achieve the goal of controlling these diseases by the year 2000. What are the laboratory procedures needed to assist in the prevention and detection of chronic disease? In this review I consider the traditional tests now used in these efforts, emphasize how and where screening for diabetes, cardiovascular disease, and cancer is now done, and describe the current status of the clinical laboratory in supporting these activities, including new and promising procedures that may be useful in identifying individuals at high risk for disease. It is important to initiate good clinical laboratory practice for these new tests as they are transferred from the research laboratory to the clinical laboratory. The laboratory will be required to provide for this need rapidly and at the same time comply with federal and state controls and regulations.

Cardiovascular Diseases↗

[Trends in the clinical biochemistry and laboratory diagnostics].

Clinical biochemistry and laboratory diagnostics develops dynamically namely due to the advance of modern analytical techniques, information technologies and with new findings in the molecular biology. According to data from the USA, 70 to 80% of medical decisions in the hospitals depend on comparatively not expensive laboratory tests which represent only 3 to 5% of the health care costs. There are three essential approach models for the automation and consolidation of laboratories in the world. Japan, USA and countries of EU stand for prototype of those directions. Japan has a high level of total laboratory automation starting with the preanalytical phase, over the analytical phase to the postanalytical phase with the partial consolidation of the discipline. In the US the high degree of laboratory consolidation is preferred with so-called modular automation. EU countries prefer high degree of modular automation, including the preanalytical processing of samples. International trends in the laboratory diagnostics manifest in the Czech Republic by modular systems in several laboratories. They can increase the effectiveness of laboratories and subsequently erase differences between the routine and statim examination and develop of molecular-biological techniques. Development of laboratory diagnostic technologies and their economical accessibility are the compulsory condition of acceleration of the diagnostics and treatment, leading to high quality, focussed and finally effectivuess of health care.

Biochemistry↗

[Clinical diagnosis and laboratory data].

Modern medicine can not be practiced without laboratory tests. Laboratory tests play a vital role from the initial stage of clinical examination. The Japanese Society of Clinical Pathology has formed a committee specifically dealing with the effective and economic use of lab tests without missing or duplicating the important tests. As is shown in table 1 in the main text "Essential Laboratory Tests" were initially agreed as those tests a patient should take when visiting a clinic regardless of the complaint. From an early stage, laboratory tests were done simultaneously with history-taking and physical examinations. Then the "Initial Impression" is obtained and "Organ-oriented 1st and 2nd screening tests" and confirmatory tests will be done to make the final diagnosis. To evaluate the validity of the "Essential Laboratory Tests", we performed the tests on 1026 patients who visited our general medicine clinic for the first time. We compared the Initial Impression with or without Essential Laboratory Tests. Cases in which a diagnosis could not be made by history-taking and physical examination were decreased from 17.4% to 8.0% by performing the essential laboratory tests. Diagnoses made without the essential laboratory tests were found to be mistaken in 10.4% and the additional use of the tests was suggested to lead to a more accurate diagnosis. In 110 cases, diseases unrelated to the chief complaints, were discovered. Even for the respiratory tract infection, CRP and WBC count, which were included in the essential laboratory tests, were very informative.

Adolescent↗

[Quality assurance in clinical laboratory diagnosis].

Both the internal and the external quality controls are necessary to achieve reliable and comparable laboratory tests. The internal quality control includes preanalytical, analytical and postanalytical checking of factors to eliminate all interferences of laboratory tests. The use of reliable methods which result in a good accuracy and precision, however, can provide results which are not comparable to the results of other laboratories. The role of the external quality control is to check differences between the laboratories and to make the results as comparable as possible. The accuracy and precision of Hungarian laboratories improved during the past decade which can be attributed to the better technical conditions, on the one hand, and to the regular internal and external quality control, on the other hand. An increasing number of the small laboratories, mostly in the service of general practitioners, are unable to perform the same quality of laboratory tests as that of the central laboratories, since their technical conditions are old-fashioned and inadequate to use up-to-date methods. The urgency of improvement in technical condition of small laboratories is obvious from both professional and economical reasons.

Clinical Laboratory Techniques↗

Legal aspects of laboratory medicine.

Societal expectations of modern laboratory medicine will engender increasing scrutiny about the accuracy of laboratory data, the timeliness of performing laboratory tests, and the transmission of the results. Laboratorians who understand basic medicolegal principles applicable to laboratory medicine will be comfortable at the interface between law and medicine, and likely will practice acceptable laboratory medicine. Good medicine is good law. The authors divide their discussion into four parts: accountability for laboratory services, quality and risk in laboratory management, forensic evidence in the laboratory, and testimony by clinical laboratory personnel.

Jurisprudence↗

Comparable laboratory performances in the analysis of lead in control samples and in fresh human blood.

The validity of quality control programs is based on the assumption that the control samples can be commuted with the real samples, so that, according to the results obtained by a given laboratory on control samples, it is possible to produce reasonable predictions about the reliability of results obtained on real samples. During the implementation of a program of biological monitoring of the general population against the risk of saturnism, a great number of data have been collected allowing the evaluation--as far as blood lead determination is concerned--of the real predictive power of the results obtained by a laboratory during a quality control program, according to its specific level of analytical reliability. The results obtained by eleven laboratories in the analysis of control samples have been compared, by regression analysis, with the results obtained on the same samples by the reference laboratory. The same procedure has been adopted for the results obtained by each laboratory and by the reference laboratory in the duplicate analysis of about 10% of the real samples collected by each center during the biological monitoring program. The comparison between the regression parameters obtained, in both cases, for each laboratory has not produced evidence of systematic differences. Furthermore, a non-parametric evaluation of the data (based on the magnitude of the differences between the results of the laboratories and the results of the reference center) shows, in most cases, similar laboratory performances in the analysis of control samples and of real samples.

Blood Chemical Analysis↗

Standardized stress testing in the cardiovascular laboratory: has it any bearing on ambulatory blood pressure values?

We examined 77 males (mean age 45 years; mean casual blood pressure 139/94 mmHg; no secondary hypertension) to evaluate the relationship between cardiovascular measures from standardized stress testing (mental arithmetic, cold pressor test) in the laboratory and 24-h ambulatory recordings of blood pressure and the heart rate. The basic relationship between laboratory and ambulatory recordings was calculated by correlating the mean of our laboratory values with 24-h mean ambulatory values. Laboratory readings of baseline and stress systolic blood pressure, diastolic blood pressure and the heart rate correlated significantly (P less than 0.05) with ambulatory recordings of 24-h means and short-period means (e.g. baseline systolic blood pressure with work mean, r = 0.33; with mean, r = 0.33). However, the correlations were no closer than the basic relationship between laboratory examinations and ambulatory recordings (r = 0.41 for systolic blood pressure; r = 0.46 for diastolic blood pressure; r = 0.43 for heart rate). There was no specifically close correlation between laboratory baseline and the corresponding ambulatory rest phase (evening, sleep) or between laboratory stress values and ambulatory phases of high demand (work mean). Reactivity measures in the laboratory (stress values-baseline values) were correlated to measures of variability in ambulatory recordings (standard deviation; coefficient of variation; maximum, minimum value; range), but, again, there was no specific effect separating similar from non-similar phases. We conclude that laboratory measures have no specific bearing on ambulatory blood pressure and heart rate measures.

Blood Pressure Determination↗

Robotics in the clinical laboratory.

We are beginning to see the potential of robotics in the clinical laboratory through integration with automated analyzers and computer systems. However, there is a need for training programs that will prepare technologists to design and implement robotic systems for clinical laboratories. What will the robot laboratory of the future look like? We will see hospital laboratories begin to be located some distance away from the main facility because the labor component of staffing satellite laboratories will have been greatly reduced. Instrument manufacturers will see the need for analyzers that are robot-friendly and allow for simplified interfacing, both electronic and mechanical. Robots will become more versatile even to the point of performing complete instrument repair. Laboratories will be equipped with many task-oriented robotic stations, including, for example, accessioning and processing robots that prepare samples for transport by robotic carts. Analysis will be performed by a combination of robot and dedicated analyzer. Laboratory results will be reviewed by algorithms in the larger laboratory computer, which will alert the laboratory worker to unusual results. A large variety of analyses will be available to the patient with rapid turnaround. The end result will be more efficient health care delivery at reduced cost.

Computer Communication Networks↗

[Laboratory animals and animal experiments].

The historical development of the use of laboratory animals runs broadly parallel with the development of western human medicine. From the latter half of the nineteenth century, after the first anaesthetics were discovered, the number of animals used for experiments showed a particularly marked increase. A number of causes of these developments are discussed. From the latter half of the twentieth century, experimental animals themselves have become a subject of investigation. The discipline of laboratory animal science is then developed. Laboratory animal science increases the reproducibility of experimental studies and contributes to the welfare of laboratory animals. An important recent development was started in teaching laboratory animal science when the Laboratory Animal Order promulgated on May 31, 1985, became operative. In this Order, the training requirements are stated, which have to be met by those taking part in animal experiments (investigators, animal technicians, experts in laboratory animal science). A particular training in laboratory animal science is made compulsory on each of these categories. The Department of Laboratory Animal Science in Utrecht has national terms of reference for university education in this field. The contents of this education is briefly discussed. Finally, a number of problems are reviewed, which are associated with testing the ethical aspects of animal experiments.

Animal Testing Alternatives↗

Cost containment: strategies and responsibilities of the laboratory manager.

In these difficult times we must not lose the sense of purpose and the personal drive that makes it possible to achieve excellence. We can be exasperated with reduced funding, burdened with excuses, debilitated with confusion about budgetary cuts, and even be stubborn about alternatives, but we must be serious about excellence and quality. It is natural that during these times we will face those with conflicting views, negative ideas, and erratic long-term goals, but that in itself should rouse us, as professionals, toward the pursuit of quality health care services. With better scheduling of tests and procedure, improved discharge planning, more careful review of the need for patient hospitalization, and a more careful examination of the number, mix, and quality of services furnished during a patient's hospital stay, we, as a health care team, can and will reduce unnecessary utilization of all services. Well-managed laboratories must operate around a return on investment threshold, from which all products, services, and expenditures are ranked. On this basis, management decisions will be made to add to service, reduce service, improve or sustain quality, change technology, or discontinue the business altogether. Given the mandate embodied in the DRG regulations, laboratories have become cost centers. New ideas, new technology, and creative efforts must now be used to improve laboratory productivity while sustaining quality health care services. It is argued philosophically that the DRGs or other major measures to reduce funding adversely affect quality of service. This may be true under the traditional definition of services, but there must be "a new order of things." Today's complex problems indicate that orthodox solutions no longer apply, and in our quest to answer who should pay versus who should receive, and how much is enough, we must ensure quality of all services offered. This new order of doing things could result in far greater savings than has previously been predicted. The patient's length of stay in the hospital has already been reduced. There will continue to be decreases in laboratory utilization and consumption of resources necessary to provide laboratory services. Cost competitiveness coupled with the laboratory's need for increased productivity will further expand savings. To summarize, the laboratory manager in the mid-1980's will have the following goals. To provide quality, cost-efficient, and timely laboratory services. To sustain and nurture the growth of the clinical laboratory profession as dictated by the needs of society and new scientific trends and discoveries.(ABSTRACT TRUNCATED AT 400 WORDS)

Cost Control↗

[Central accounting as a model of laboratory diagnosis].

From the experiences in the field of scientific organisation of the last years results a laboratory-diagnostic model with an automatic laboratory, a district laboratory and larger central units, so-called coordination laboratories which work together with about 10 to 20 laboratories and guarantee an up-to-date diagnostic spectre for the whole territory. Apart from the increasing investigation frequency, a constant dilatation of the diagnostic spectre and improved quality control of structural conditions must be taken into consideration. The constructed model which demands the collaboration of all institutions meets these critical problems. A central balancing should also extend to the personal and technical apparative capacity. Apart from this the system is to be extended by further automation in the sense of a machine activity with improvement by control and regulation processes. An electronic data processing improves the functional capacity only when the analytic data processing has achieved a high level. The cooperation in the field of laboratory diagnostics is not only a task in scientific organisation, but in the same way also scientific problems are solved together. The requirements increasing in qualitative and quantitative respect may optimally be fulfilled only by the two partners, clinic and laboratory. With increasing independence the laboratories should in scientific and organizational respect remain a place of meeting for laboratory scientist and physician.

Clinical Laboratory Techniques↗

An analysis of cost studies performed in public health laboratories.

From 1973 to 1976, 23 public health laboratories performed cost accounting studies with the assistance of the Laboratory Management Consultation Office, Center for Disease Control. Cose data obtained in 16 of these laboratories were used as the basis of a discussion on the identification of indirect expenses and the method of reapportioning these costs to the diagnostic testing sections of the laboratories. Calculations of cost-per-weighted units and cost-per-test of some laboratory diagnostic sections are presented. A laboratory administrator can gain some insight into the effectiveness of resource utilization within his own laboratory by identifying cost center expenditures and considering differences in cost-per-weighted unit among the various revenue-producing sections. With the currently available data, no significant relationship between indirect costs and overall laboratory cost-per-weighted unit was demonstrated. It is hoped that additional data can be gathered and other indices developed which will help laboratory management to more precisely identify and then control indirect costs.

Accounting↗

Error rates in Australian chemical pathology laboratories.

OBJECTIVE: To measure transcription and analytical errors made by Australian chemical pathology laboratories. DESIGN: Retrospective data collection covering the period 1 November 1993 to 1 April 1994. SETTING AND PARTICIPANTS: Fourteen pathology laboratories in five Australian States (seven in the public sector, and seven in the private sector). MAIN OUTCOME MEASURES: Error rates in transcribing information from request forms to computer record systems, and laboratory performance on chemical analysis. RESULTS: Pathology laboratories had a transcription-error rate of up to 39% and an error rate of up to 26% for analytical results. The worst-performing laboratory had errors (of patient identification or results of analysis) in 46% of requests. The three best-performing laboratories achieved 85% error-free reporting, with one achieving 95%. CONCLUSIONS: Error rates in Australian pathology laboratories vary widely, but may be as high as 46% for all specimens in some laboratories. The types of errors reported were under the control of the laboratory, and would affect the accuracy of reported pathology test results, with potential adverse outcomes for patient care and inefficient use of health-care resources. There is a need to establish broader quality assurance programs and performance requirements to reduce these types of error.

Australia↗

Determination of reference method values by isotope dilution-gas chromatography/mass spectrometry: a five years' experience of two European Reference Laboratories.

We report on the cooperation of two European Reference Laboratories for the determination of reference method values in serum based materials intended for use in internal accuracy control and external quality assessment. Reference method values were determined by isotope dilution-gas chromatography/mass spectrometry for aldosterone, cortisol, oestradiol-17 beta, progesterone, testosterone, thyroxine, theophylline, cholesterol, creatinine, glucose, total triacylglycerols and uric acid. All determinations were done in parallel in the two laboratories, independently and within certain time constraints. The general measurement design consisted of duplicate measurement of each sample on three different occasions. In each laboratory, rigorous internal quality control was performed according to predefined analytical quality specifications. This was done using certified reference materials. If not available, control materials targeted before by the two laboratories were utilized. Here we present the results of the cooperation during five years. We discuss the precision and accuracy achieved, the between-laboratory agreement and the total analytical error. For the hormones and theophylline, the mean overall coefficient of variation for both laboratories (calculated from the measurements on three days) was always < 2%, for the substrates < 1%. For all substances, the method bias (estimated from several measurement series over the five years) was < 1%, and the average deviation of the results between the two laboratories was < 1.2%. The maximum total analytical error was in all cases < 3%. These data demonstrate that current reference methodology is able to guarantee a stable level of high quality of performance, and that reference laboratories of today are capable of providing, in due time, adequate service in the framework of accuracy-based harmonization of methods in routine laboratory medicine.

Aldosterone↗

Robotics and the changing face of the clinical laboratory.

Rapid changes in healthcare coupled with parallel advances in technology have stimulated the evolution of new approaches for laboratory automation. In particular, the emergence of commercially available laboratory robotic systems offers promise for streamlining the clinical laboratory. Increasing cost-containment pressures make the application of this technology extremely attractive, and several organizations have begun to systematically integrate robotic devices into their laboratory automation schemes. Integration of these technologies, however, presents many challenges for software developers, instrument manufacturers, and laboratory workers. Differing needs across laboratories require flexibility and intelligence in robots, instruments, and control systems. Standardization of mechanical and electronic interfaces will be key to making these systems easy to integrate. Systems engineering, aided by simulation modeling and artificial intelligence schemes, will be important to assist in the design of optimal configurations. Software for the overall control of integrated automation will be needed that can be tailored by the laboratorian to fit the requirements of the individual laboratory. Thus, laboratory workers will need to be actively involved in implementing this new wave of laboratory automation, becoming well-versed in computers, electronics, and systems engineering.

Autoanalysis↗

Essential criteria for quality systems in medical laboratories.

The introduction of total quality systems in medical and clinical laboratories and accreditation of these laboratories is gaining more and more interest. In several countries laboratories have set up quality systems, and accrediation schemes are also operating. The standards of these schemes have much in common although several differences exist. There exists uncertainty in several countries on the choice of a system. Laboratory specialists are confronted with a new way of thinking concerning the management and daily practice of their laboratories. It is not clear, which standards should be used as a basis, and certainly not how to interpret such standards. Particulary in the European Union, harmonisation of criteria for quality systems is desirable. In the present paper, the document entitled "Essential Criteria for Quality Systems in Medical Laboratories" is presented. The document has been accepted in the general Assembly of the European Communities Confederation of Clinical Chemistry (EC4) and by the working group on Good Laboratory Services of the European Council on Laboratory Medicine (ECLM). The criteria in the document are focussed on the particular situation of medical laboratories, including pre- and post-analytical aspects. Reference is made, where applicable, to EN 45001, ISO 9001 and ISO guide 25 draft 3.

Chemistry, Clinical↗

[Evaluation of results for controlling the variability of diagnostic tests for intestinal bacteria introduced to the laboratories of sanitary-epidemiologic stations in 1995].

In this testing bacteriological laboratories of 49 epidemiological stations were participating. Eleven control tests were prepared in form of lyophilize faecal samples containing three different organisms in each sample with pathogenic organisms present in each of 10 tests (a different species in each test) along with a non-pathogenic Enterobacteriaceae strain, while the 11th test contained only organisms belonging to physiological intestinal flora. Each laboratory received two different tests for doing them. The following bacterial strains were used S. oranienburg var, lac+ S. muenster, S. infantis, S. sonnei, S. flexneri, A. hydrophila, Y. enterocolitica, E. coli 018, E. coli 026, E. coli 0124, and as accompanying organisms: C. freundii var lac+ and lac-, P. mirabilis and H. alvei. Among 49 participating laboratories 31 (63.3%) detected the etiological infectious agent in both samples, or its absence was shown in the 11th test. In 23 laboratories (46.9%) the cultured organisms were species-grouped or their serological type was established, in the remaining 8 laboratories (16.3%) the identification was incomplete or serological type was not correctly recognized. In 15 laboratories (30.6%) the infectious agent was found in only one test, and in 12 of these laboratories (25.5%) the cultured organism were identified correctly completely, and in 3 (6.1%) identification was incomplete or serological type was not correctly recognized. In 3 (6.1%) among 49 laboratories the infectious agent was not found in any test. The study made possible an insight into the reliability of the diagnostic tests for Enterobacteriaceae carried out in the sanitary-epidemiological stations. The use of faeces-simulating samples made possible to assess not only the correct identification of the isolated organisms, but also to trace the course of the diagnostic management used in each laboratory for testing of faeces samples.

Clinical Laboratory Techniques↗