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[Can a laboratory investigation be called anything? "The NPU system" sorts out the concepts and gives systematic stringency].

When communicating results from laboratory investigations from the laboratory to the requesters and further between different information systems, it is important that the value as well as the unique identity and name of the laboratory investigation are correctly cited. A committee under the International Federation for Clinical Chemistry and Laboratory Medicine (IFCC) and International Union for Pure and Applied Chemistry (IUPAC) has developed a systematic nomenclature for the correct classification of laboratory investigations. Each generic laboratory investigation is provided with a unique NPU code. The system is in use among approximately 30 different clinical laboratories in Sweden, and has capacity to be the common denominator of all laboratory investigations, and to be used as the identifier in various information systems. The NPU system for the Swedish laboratories is currently administered by EQUALIS and partly financed by the participating laboratories. Other ways of funding, of benefit for the whole health care sector, will be investigated.

Chemistry, Clinical↗

A comparison of results of fluoride determinations by different laboratories.

With water fluoridation imminent in South Africa, the accurate determination of the fluoride content of water is important. The aim of this study was to compare the fluoride content of water reported by 9 laboratories and the laboratory at the South African Bureau of Standards (SABS). The SABS and 9 South African laboratories were asked to determine the fluoride content of five water samples. The fluoride content of the samples was in a range that could be expected in South African waters. The laboratories were requested to disclose their methods for fluoride determination. The results reported by the laboratories were compared to the results reported by the SABS laboratory. Fluoride concentrations of 0.13, 0.22 and 0.58 mg/litre were reproduced to within 0.05 mg/litre by two, six and three laboratories respectively. At the 1.1 and 1.5 mg/litre concentration no laboratory could achieve this accuracy. Four different methods for the determination of fluoride were used. At present laboratories determining fluoride concentrations are not accurate enough to ensure that the process of water fluoridation will be safe. Laboratories will have to check their procedures to ensure better results before water fluoridation can commence.

Cariostatic Agents↗

[Status of the clinical laboratory in the mandatory postgraduate medical training system: introduction].

To understand the role of the clinical laboratory in the era of mandatory postgraduate medical training, I carried out a questionnaire survey in April 2005 among both university hospitals and clinical teaching hospitals located in the Kinki area. As a result, eleven (84.6%) of the 13 responding laboratories participated in clinical laboratory medical education with an obligatory training program (5 laboratories), with an elective program (3 labs) or both (3 labs). Among the 8 laboratories with an obligatory program, educational lecture subjects included reversed clinicopathological conference (7 labs), blood transfusion (4 labs), laboratory microbiology (4 labs), and blood gas analysis (BGA) (3 labs). On the other hand, in the elective training programs among 6 laboratories, laboratory microbiology including infection control was most frequently held (4 labs) followed by blood transfusion, laboratory hematology and urinalysis (3 labs respectively). Concerning 4 areas, namely, blood transfusion, 12-lead electrocardiography at rest, BGA and ultrasonography, which have been defined as obligatory laboratory techniques for all trainees in mandatory postgraduate medical training, the majority (84.6%) of the responders in this survey replied that they were not sufficient, whereas, Gram's staining was most frequently (69.2%) recommended as an additional obligatory technique in mandatory postgraduate medical training.

Education, Medical, Graduate↗

A survey of laboratory services for the diagnosis of Legionnaires' disease in Scotland.

As laboratory investigation is essential for the diagnosis of Legionnaires' Disease, the lack of immediate access to a suitable laboratory may result in under, or late, diagnosis. Recently, there has been emphasis on culture as the principal means of diagnosis. This survey describes the diagnostic facilities for Legionnaires' Disease in Scottish hospitals, particularly in relation to the role of the acting reference laboratory in Ruchill Hospital, Glasgow. Facilities have clearly been expanding, with six laboratories setting up local services since 1985. In 1990, 16 out of 36 laboratories (44%) in 10 out of 15 health boards offered diagnostic tests for Legionnaires' Disease; of these 14 offered culture. All laboratories used the acting reference laboratory (directly or indirectly) to confirm positive results. Three laboratories stated that they would test all specimens from patients with pneumonia; the others would do so only on request or when indicated by clinical judgement. These findings provide confidence about the completeness of the surveillance data compiled at the acting reference laboratory and make easier the interpretation of information about geographical and secular variations in disease incidence. Further expansion of diagnostic facilities, particularly culture, with continuing use of the acting reference laboratory for more complex tests, conformation of results and quality control, would meet the objectives of early diagnosis and effective surveillance.

Humans↗

Proficiency testing in cytology laboratories in Ontario, Canada: a decade of experience. I. Introduction and description of the testing model.

There are few formally documented proficiency testing programs for cytology laboratories, and those that have been documented are not entirely comparable in format. The first of three papers documenting a mandatory universal proficiency testing program for cytology laboratories in the Province of Ontario, Canada, presents data on the structure and function of the participating laboratories (including a comparison of the data for 1974 and 1980) and on the organization of the testing model (including selection of terminology, construction and use of the survey and assessment of responses). In 1980, of the 463 medical laboratories in Ontario, 91 of 222 hospital laboratories and 65 of 216 nonhospital laboratories were licensed in cytology. In that year, the 156 cytology laboratories processed 1.48 million cytology specimens, 92% of which were gynecologic. Hospital laboratories processed 87.5% of the nongynecologic cytology specimens and 30% of the gynecologic cytology specimens. These proportions have been virtually constant for several years. Between 1974 and 1980, there was a trend in Ontario to fewer laboratories processing less than 5,000 cytology specimens per annum. Subsequent papers in this series describe the results of the initial surveys in this program and a precision study to evaluate the consistency of reporting by individual laboratories.

Cytological Techniques↗

Laboratory performance and regulatory requirements.

We compared performance levels of four clinical laboratory groups defined by federal regulatory characteristics, to assess the appropriateness of selected regulations: laboratories in JCAH-accredited hospitals; non-doctoral-directed independent laboratories; state-regulated but federally exempt group-practice laboratories; and unregulated laboratories in physicians' offices (POLs). Federal regulations evaluated were those dealing with the doctoral directorship requirement and exemption of POLs from regulation. Quantitative analytes were compared by using linear regression on log-normal transformations of mean absolute-z scores of proficiency test results. The scope of services offered by laboratories was statistically related to performance in quantitative analytes. Confounding effects of scope-of-service levels were statistically controlled. Proportions of errors in qualitative analytes were compared. No pattern of statistically discernible differences in performance was found between hospital laboratories and non-doctoral-directed laboratories. Both regulated non-doctoral-directed laboratories and state-regulated but federally exempt group-practice laboratories demonstrated higher levels of performance than unregulated POLs.

Hospitals↗

Laboratory computers: tools for increased productivity.

Revolutionary changes in the computer industry brought about in part by the introduction of personal computers are now reaching into clinical laboratories everywhere. Although the true justification for any computer tool may be an intangible one such as improvement in service, such tools can typically be cost justified by increases in productivity alone. A broad spectrum of applications software useful in the medical laboratory is now available in any scale required to meet the needs of any size of laboratory. Perhaps one of the most dramatic changes in this field in the last several years has been the introduction of small-scale integrated laboratory systems that are true small-scale laboratory information systems. As a result, smaller laboratories can now acquire laboratory information systems appropriately scaled to their workload for a fraction of the cost of the large systems. These small laboratory information systems are typically more easily cost justified than larger ones. Achieving productivity gains using computer tools in the laboratory is a management-intensive process requiring careful analysis and thorough planning. Laboratory managers who eschew computer tools are now an anachronism; extinction of this species is imminent.

Computers↗

Role played by narcotics laboratories in the campaign against drug abuse and drug trafficking: a view from a developing country.

The narcotics laboratory at the national level identifies drugs for abuse and their accompanying substances in suspected samples, determines the purity and the possible origin of illicit drugs, carries out drug-related research, particularly on new sources of drugs liable to abuse, and, when required by the police or courts of law, provides supportive expertise in drug trafficking cases. Precaution must be taken to ensure that samples to be examined are representative. The university is a particularly appropriate setting for the location of a narcotics laboratory, especially if such a laboratory carries out complex work requiring assistance from other professional disciplines. Before new laboratory equipment is purchased, a careful study of requirements and financial resources should be made to ensure economical and optimum utilization of such equipment. In some situations the use of simple techniques, such as thin-layer chromatography, can be sufficient, while in others more sophisticated techniques may be required. Appropriate training of personnel is of particular importance for the effective functioning of a narcotics laboratory. The laboratory of the Department of Toxicology and Forensic Chemistry, University of Buenos Aires, provides for the training of personnel at three levels: The first level consists of basic training, which includes the use of kits for rapid identification of drugs in field conditions, for personnel from the police, gendarmerie, prefecture, customs and other agencies which deal with drug problems, but which have no previous skills in laboratory techniques; The second level is provided for professional laboratory personnel and usually lasts six months; The third level consists of two years' postgraduate university training for students who are expected to carry out complex laboratory work; an additional year is provided for trainees who are expected to assume responsibility in a laboratory unit.

Cannabis↗

Improving laboratory testing: can we get physicians to focus on outcome?

Managed care is changing the financing of healthcare and replacing open-ended reimbursement with fixed pricing schemes. Clinical laboratory tests will remain an important part of medical practice because laboratory information is essential for diagnosis and management of patients. The relative role of the hospital-based clinical laboratory, however, remains to be determined because healthcare organizations are reevaluating their services and attempting to drive down costs through reducing unit costs, decreasing utilization of services, and improving patient outcomes. The challenge for the clinical laboratory in managed care is to achieve appropriate utilization of laboratory tests so that clinical outcomes are optimized. The clinical laboratory at this medical center has used a number of approaches to improve utilization of thyroid function tests, isoenzyme tests for myocardial infarction, beta-human chorionic gonadotropin tests, and stat laboratory services for the emergency department. These experiences suggest that the laboratory can contribute to optimizing utilization of laboratory tests. This goal will require mutual cooperation of both the clinician and the clinical laboratory physician and (or) scientist.

Chorionic Gonadotropin↗

[Quality control in an immunohematology laboratory in the Croatian Transfusion Service].

In order to evaluate the testing proficiency in immunohematological laboratories in Croatia blood samples were prepared and fully examined in the Croatian Institute for Transfusion Medicine and sent to all the transfusion laboratories in the country. The laboratories were asked to perform the following tests: determination of AB0 blood group and Rh phenotype; detection and identification of irregular antibodies and crossmatches between serum and RBCs. All the laboratories (100%) accurately determined AB0 and Rh(D) negative blood groups and crossmatch between compatible serum and RBCs. In 80.65% of the laboratories, Rh(Du) blood group was accurately determined. The incompatibility between serum and Rh(Du) RBCs in crossmatch was detected in 93.55% of the laboratories. 96.77% laboratories correctly detected irregular antibodies. Only 35.48% of the laboratories accurately identified anti-D and anti-C alloantibodies in the serum, 32.26% failed to identify one of the two antibodies and 29.03% of the laboratories detected irregular antibodies but did not identify their specificity. Only 35.48% of the laboratories correctly performed all the tasks.

Blood Grouping and Crossmatching↗

Employment patterns and turnover among laboratory personnel: a twenty-year study.

A longitudinal study of employment patterns and turnover of clinical laboratory personnel in the Minneapolis-St. Paul area was conducted for the years 1970, 1980, and 1990. Laboratory staffing patterns for the years studied showed a general plateau in numbers and categories of personnel between 1980 and 1990, following a doubling in those numbers between 1970 and 1980. In 1990, for a geographic area of 2.2 million people, a total of 2,500 laboratory personnel were employed in 31 major laboratories. Fifty-six percent were medical technologists (clinical laboratory scientists), 6% cytotechnologists and histologic technicians, 23% laboratory technicians, 9% phlebotomists, and 7% in "other" categories. The ratio of full- to part-time employees was approximately 3 to 1. Between 1970 and 1990, annual turnover rates for all laboratory personnel declined from 20% to 15%. In 1990, the personnel group experiencing the lowest turnover was in cytotechnology (4%) and the rate for medical technologists was 9%. The turnover for laboratory technicians was 17%, and the rate for histologic technicians was 19%. Highest turnover occurred among phlebotomists (36%) and "others" (39%). While the numbers of laboratory personnel employed leveled off between 1980 and 1990, numbers of new graduate technologists and technicians decreased by approximately one-half. Personnel shortages in laboratory science can therefore be expected to continue.

Employment↗

Searching for inaccuracy in clinical laboratory testing using Medicare data. Evidence for prothrombin time.

OBJECTIVE: To determine if the occurrence of health outcomes following clinical laboratory testing can be used to identify types of laboratories that may be having higher than expected error rates. DESIGN: Retrospective analysis of Medicare Part B outpatient claims, Part A hospitalization bills, and death records using a case-control study. SETTING: Medicare records from six carrier territories were sampled during the period 1985 through 1987. PATIENTS: A total of 14,755 Medicare patients receiving a prothrombin time test in either a physician office laboratory or a commercial laboratory. OUTCOME MEASURES: Occurrence of a hospitalization for stroke or acute myocardial infarction, death, or no adverse outcome within 6 days of a prothrombin time. RESULTS: In physician office laboratories where prothrombin time test volume is below 40 per month, the odds that a tested patient will experience a stroke or an acute myocardial infarction are up to 1.96 and 3.43 times greater, respectively, than for a similar patient tested in a commercial laboratory. Switching from one laboratory to another between successive prothrombin time tests increased the odds of a stroke or an acute myocardial infarction by 1.57 and 1.32, respectively. Patients in two states with strong laboratory regulatory programs had fewer adverse outcomes. CONCLUSION: Examining patient outcomes subsequent to clinical laboratory testing may be a useful tool for clinical laboratory quality assurance.

Case-Control Studies↗

Statewide survey of laboratories performing Mycobacterium tuberculosis testing in Minnesota.

Rapid and accurate laboratory detection and identification of Mycobacterium tuberculosis, particularly multidrug-resistant strains, is critical to both public health control measures and patient management. The authors surveyed microbiology laboratories to evaluate whether their methods met national guidelines. As needed, laboratories received individualized recommendations for improvement. The laboratories were resurveyed a year later to assess changes in methods. Current guidelines recommend fluorochrome acid-fast smears, broth cultures, identification by nucleic acid probe or BACTEC-NAP, and BACTEC primary susceptibility panels, which should include pyrazinamide. Of 27 laboratories performing acid-fast smears, 15 used fluorochrome methods. Six of 16 laboratories performing mycobacterial cultures used broth media. Of six laboratories performing species identification, five used nucleic acid probes or BACTEC-NAP. Of five laboratories evaluating drug sensitivity, two used BACTEC and two included pyrazinamide in their protocols. Overall, 24 (89%) laboratories needed improvements; a year later, 16 (67%) of those had altered their methods or made definite plans to do so. Survey results suggest that health departments can facilitate improvements in laboratory testing for pathogens of public health importance.

Data Collection↗

[Quality of the performance of clinical laboratories].

The quality performance of clinical laboratories plays a basic role in the quality and effectiveness of health care. The reliability of laboratory tests, however, depends on the quality assurance system existing in the working place, which comprises not only the analytical activities but includes all preventive measures and their regular control in connection with the preanalytical phase, as well as the plausibility control and interpretation of results. The external quality assessment of laboratory work gives information about the systematic errors existing between results of different laboratories, and it helps to discover rough errors of either random or systematic origin. The external quality assessment of medical laboratories has its beginning in early 1970's in Hungary and since 1975 it is organized continuously by the National Institute. In recent years, the external quality assessment of laboratories is performed in cooperation and support of the INSTAND e.V./WHO Collaborating Center (Düsseldorf). The paper surveys the quality performance of laboratories in routine clinical chemistry, haematology, blood-coagulation, hormone and blood-gas analysis. Moreover, the evaluation of results on the basis of reference and assigned values measured in the reference laboratories and according to the statistical error of results of participants is also discussed. Further improvement in the quality performance of health laboratory service needs the introduction of unified quality system which includes details of all elements of knowledges and technical activities necessary to fulfill requirement of reliable and effective laboratory work.

Humans↗

Enhanced clinical consulting--moving toward the core competencies of laboratory professionals.

The large menu of laboratory assays available today makes it increasingly difficult for the non-specialist to order all necessary tests, avoid medical errors, and still contain cost. Curbside consultations, "intelligent" laboratory information systems, and medical information from the Internet cannot fully fill the need for expert advice on test selection and interpretation of laboratory results. In this communication, we show the need for a more active role for laboratory physicians to select and interpret tests, demonstrate that existing attempts to deal with this issue are insufficient, and describe the model system which we have instituted at our institution. We combine reflexive testing algorithms with narrative interpretations provided by medical laboratory professionals and thereby enable physicians to obtain relevant laboratory results and to arrive at a definitive diagnosis without having to order individual tests. In our experience, such an arrangement can significantly improve the quality of care and reduce the cost per case by decreasing the time to diagnosis, the number of tests ordered, and the number of patient visits. In addition, interpretations provide a new source of professional revenue for the expert laboratory physician. This leads to a new role for laboratory professionals, in which their expertise in the selection and interpretation of laboratory tests is fully utilized.

Algorithms↗

Exposure of laboratory workers to Francisella tularensis despite a bioterrorism procedure.

A rapidly fatal case of pulmonary tularemia in a 43-year-old man who was transferred to a tertiary care facility is presented. The microbiology laboratory and autopsy services were not notified of the clinical suspicion of tularemia by the service caring for the patient. Despite having a laboratory bioterrorism procedure in place and adhering to established laboratory protocol, 12 microbiology laboratory employees were exposed to Francisella tularensis and the identification of the organism was delayed due to lack of notification of the laboratory of the clinical suspicion of tularemia. A total of 11 microbiology employees and two persons involved in performing the patient's autopsy received prophylactic doxycycline due to concerns of transmission. None of them developed signs or symptoms of tularemia. One microbiology laboratory employee was pregnant and declined prophylactic antibiotics. As a result of this event, the microbiology laboratory has incorporated flow charts directly into the bench procedures for several highly infectious agents that may be agents of bioterrorism. This should permit more rapid recognition of an isolate for referral to a Level B laboratory for definitive identification and should improve laboratory safety.

Adult↗

[Revolution of the health care delivery system and its impacts on laboratory testing in the United States].

Failure to slow the exponential growth of total health care expenditures in the United States through the government policies resulted in a rapid and progressive penetration of managed care organizations(MCOs) in the early 1990s. Diagnostic testing is viewed as a "commodity" rather than a medical service under the managed care environment. Traditional hospital-based laboratories are placed in a downward spiral with the advent of managed care era. A massive reduction of in-house testing resulted from shorter lengths of patients' hospital stay and a marked decrease in admission under the dominance of managed care urges them to develop strategies for restoring tests deprived by the managed care-associated new businesses: consolidation and networking, participation in the outreach-testing market, and point-of-care/satellite laboratory testing in non-traditional, ambulatory settings are major strategies for survival of hospital laboratories. A number of physicians' office laboratories(POLs) have been closed owing to regulatory restrictions imposed by the Clinical Laboratory Improvement Amendments of 1988(CLIA '88), and to the expanded penetration of MCOs which limit reimbursement to a very few in-house procedures. It seems likely that POLs and hospital laboratories continue to reduce test volumes, while commercial reference laboratories(CRLs) gain more tests through contracting with MCOs. In the current stream of managed care dominance in the United States, clinical laboratories are changing their basic operation focus and mission in response to the aggressively changing landscape. Traditional laboratories which are unwilling to adapt themselves to the new environment will not survive in this country.

Clinical Laboratory Techniques↗

[Considering what clinical laboratories should become in the future--POCT, mail testing and OTC test].

Medical staff working in laboratories have shown little or no interest in POCT, mail testing and OTC test. POCT and mail testing are laboratory systems that respectively involve a series of laboratory processes (advice on sampling, interpretation of data, referral to a doctor, etc.). However, the usefulness of data in the two systems differs. Data in POCT are directly used for medical treatment and those in mail testing are used as screening for health control or self-medication. OTC test is different from POCT and mail testing. People buy materials for OTC test at a drug store, then perform it and interpret the data by themselves. There are several factors in the development of POCT, mail testing and OTC test, for example the awareness of people about participation and responsibility for their own medical care, control of lifestyle-related diseases, relaxation of governmental regulation and development of technologies. These laboratories will grow gradually and influence clinical laboratories in medical facilities as well as commercial laboratories. Medical technologists and laboratory physicians should contribute to the sound development of these laboratories. As things are being changing so rapidly, medical technologists and laboratory physicians are forced to realign.

Clinical Laboratory Techniques↗