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PubMed2003

Clinical manifestations, epidemiology, and laboratory diagnosis of human monocytotropic ehrlichiosis in a commercial laboratory setting.

Clinical, epidemiological, and laboratory diagnostic issues of human monocytotropic ehrlichiosis (HME) were investigated in a retrospective case study conducted at a national reference laboratory (Focus Technologies, formerly MRL Reference Laboratory), and at the University of Texas Medical Branch at Galveston, Texas, during 1997 and 1998. Standard questionnaires were sent to physicians for each laboratory-diagnosed patient 2 days to 2 weeks after immunofluorescent antibody assay results were available. Among the 41 cases for which data were obtained, 32 (78%) were definite cases of HME, and 9 (22%) were probable cases of HME. Tick bite or exposure to ticks was recorded in more than 97% of cases. The most prominent clinical findings were fever, abdominal tenderness, and regional lymphadenopathy. There was an association between age and severity of illness. The main laboratory findings included leukopenia, thrombocytopenia, and elevated aspartate aminotransferase and alanine aminotransferase. Clinical and laboratory findings were nonspecific and were not good predictors of the severity of illness. The 90% of patients who received doxycycline treatment underwent rapid clinical improvement with a favorable outcome. The usual duration of effective treatment with doxycycline was 7 to 10 days. This retrospective study is unique because it was based in a commercial reference laboratory setting that receives specimens from different geographic locations. The clinical and laboratory information from 41 patients provides insight into the epidemiological, clinical, and laboratory characteristics of HME.

Adolescent↗
PubMed1982

System for laboratory proficiency testing in bacteriology: organisation and impact on microbiology laboratories in health care facilities funded by the Ontario Government.

The Ministry of Health requires that all medical laboratories in the Province of Ontario participate in a laboratory proficiency testing program (LPTP). In bacteriology compliance has been excellent. Eighty-six laboratories, for various reasons over the period under review, have surrendered their licence or, because of poor performance on LPTP test surveys, have had their licence withdrawn by the Ministry. The highest percentage of withdrawals occurred in small hospitals in isolated areas. In April 1979 there were 249 participating laboratories. Participants' results are first analysed by computer, and, subsequently, approximately 20% of participants' reports are reviewed by the Committee. Various Committee actions ensue: correspondence with the laboratory director regarding errors; an offer of a visit; and possibly a report via a senior LPTP committee to the Ministry that a laboratory is non-proficient and, in LPTP's terms of reference, non-remediable. Subsequent Ministry action might be the withdrawal of a laboratory's licence. However, this last recourse only occurs when educational efforts have proved ineffectual. Overall, performance in LPTP bacteriology surveys has improved over the period 1975-8, with 68% of 263 laboratories achieving a score of 70% or higher and 26% of 263 laboratories scoring less than 60%.

Bacteria↗
PubMed2000

Laboratory expenditure in Pegasus Medical Group: a comparison of high and low users of laboratory tests with academics.

AIMS: To determine, through the use of clinical vignettes, whether low and high cost users of laboratory tests in Pegasus Medical Group (Pegasus) differed in their choice of laboratory tests from academics as a means of further investigating issues relating to quality and cost in laboratory testing. METHODS: Seven clinical vignettes were drawn up and sent to 30 selected members in Pegasus whose actual laboratory expenditure per consultation ranged from a mean of $2.3 in a low cost group (15 members) to $12.2 in a high cost group (15 members). The vignettes were also sent to 15 general practitioner academics. Respondents were requested to complete a laboratory form as to which tests they would use for each individual scenario. The answers were analysed for overall cost as well as numbers of laboratory tests requested. RESULTS: There were 14 academic responses and 13 each from the bottom and top laboratory users. Overall results for the seven vignette cases showed that low cost laboratory users would spend a total of $176.3, the academics $188.8, and the high cost users $219.5 on the cases. The mean per case costs were $25.2, $27.0 and $31.4 respectively. There was a clear tendency for high volume users of tests in each vignette to be high in others suggesting that doctor rather than patient factors were the main explanation of the variation. CONCLUSIONS: Clinical vignettes do not appear to be a useful strategy in clarifying issues related to quality and cost in laboratory utilisation. Test ordering behaviour appears, from the international literature and this study, to be determined more by personal doctor factors than by objective evidence and clinical need. Further work is needed to clarify the relationship between quality and the wide variation observed in utilisation and expenditure.

Adult↗
PubMed1991

European Good Laboratory and Clinical Practices: their relevance to clinical pathology laboratories.

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)

Clinical Trials as Topic↗
PubMed2000

[Good laboratory management and clinical laboratory physician].

Medical expenses have been increasing annually, and reducing expenses while maintaining effective medical care is desirable. In the late 1990s, Japanese government introduced policies expected to improve the medical security system. In the clinical laboratory field, some revisions such as packaging of certain tests(blanket test), separation between performance and interpretation fees for laboratory test, proper use of tumor markers, and additional fees for sample management. Japanese government also wants the clinical laboratory to return accurate laboratory test result to patients and physicians. Laboratory physicians have to make a great effort to manage clinical laboratories according to the guideline for GIOs of laboratory physicians from the Japanese Society of Clinical Pathology. The laboratory physician is the key person for good laboratory management.

Humans↗
PubMed1999

Laboratory restructuring in metropolitan Edmonton: a model for laboratory reorganization in Canada.

In 1994 the Alberta government acted to reduce to a decade-long deficit in the provincial budget with draconian reductions in the health, education and welfare expenditures. As a result, funding to Alberta clinical laboratories was to be reduced by approximately 40%. In response, the private and public laboratories in metropolitan Edmonton formed a unique alliance to provide laboratory testing in a more coordinated and efficient manner. Of the five metropolitan hospitals, only University of Alberta Hospital preserved its full service laboratory and its specialty reference testing. The other hospital laboratories were converted to rapid response laboratories with a merged private reference laboratory providing routine testing and support to the four hospitals, and far fewer outpatient collection facilities. This paper describes the steps in the laboratory restructuring from inception to execution.

Alberta↗
PubMed1999

A new direction in automated laboratory testing in Japan: five years of experience with total laboratory automation system management.

The introduction of integrated laboratory systems has proceeded rapidly in Japan in these 15 years, but they require large initial investment for installation and do not always succeed in reducing laboratory cost. We also experienced three major events that taught us that total laboratory systems are not always effective: these were an earthquake, a nerve gas attack, and an outbreak of food poisoning. Political changes in the national health care system in Japan have forced the cutting of expenses for laboratory testing. In this context, cost-effective laboratory testing has been considered, and many hospitals have replaced total laboratory systems with small laboratory systems. Our University Hospital introduced a mini-lab system consisting of compact instruments to increase laboratory efficiency, and we have begun point-of-care testing education for medical students. This combination enables rapid and convenient testing, and is responsive to the political changes in the Japanese health care system.

Automation↗
PubMed2000

[What should a laboratory physician expect from a microbiology laboratory?].

Remarkable changes are affecting the discipline of Clinical Pathology/Laboratory Medicine in Japan. Laboratories are changing from revenue centers to cost centers that have many serious problems(ex. closure of the clinical laboratories in the hospitals and outsourcing of laboratory tests due to restructuring in response to economic aspect, limited numbers of certified laboratory physicians, and other factors). And many clinicians in university hospitals do not know what they should expect correctly from the microbiology laboratory. Therefore, we, laboratory physicians and medical technologists must modify our behavior effectively and establish a good collaborative partnership with physicians, nurses and other health care professionals. The microbiology laboratory should provide information that will affect clinical management guidelines for obtaining specimens, microbial identification, antimicrobial susceptibilities, reporting of data and educational updating. Leadership and management skills must be increasingly critical to the success of laboratory physicians in and outside of academic centers.

Certification↗
PubMed1991

[Good Laboratory Practice (GPL) and quality control in Dutch laboratories].

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.

Animal Welfare↗
PubMed1994

[Practical training adopted from essential laboratory tests in laboratory medicine].

A proposal of essential laboratory tests, made by the Japan Society of Clinical Pathology in 1989, was applied to the education of medical students in Tokushima University. The effects of this proposal on lecture and practice of laboratory medicine were evaluated by obtaining information through a questionnaire from students and clinicians. Our curriculum of laboratory medicine generally received good assessment from students and my opinion and practical training on essential laboratory tests were understood by them. The mean coefficient of variation of intra-assay precision was 3.7% and mean recovery was 70.3 at the measurement for serum protein concentration, which is one of the items in the essential laboratory tests. However, the quality of this experiment was not in accordance with the scholarly attainments or the results of the state examination for physicians. The clinicians in service at the medical school have more selected items than items of essential laboratory tests both at the initial outpatient examination and at hospital admission. Therefore, essential laboratory tests in daily primary medical care may be considered from a different standpoint, when used in the education of laboratory medicine.

Adult↗
PubMed1987

Understanding laboratory test results. Conditions for appropriate use of laboratory tests.

The appropriate use of laboratory tests requires that valid, reliable, and reproducible data be obtained and that the clinician know both how to interpret the information provided by diagnostic tests and how to apply it to individual clinical situations. Appropriate interpretation and clinical use of diagnostic tests requires that clinicians understand the principles of laboratory testing, the information provided and not provided by laboratory tests, and how to evaluate the clinical efficacy of laboratory tests. As laboratory testing moves from regional and hospital laboratories into office laboratories, clinicians need to become more knowledgeable regarding the technical and quality control factors that affect diagnostic test accuracy. This will require the establishment of stronger, more effective links between clinicians and laboratory pathologists.

Clinical Laboratory Techniques↗
PubMed2000

Ability of laboratories to detect emerging antimicrobial resistance in nosocomial pathogens: a survey of project ICARE laboratories.

A proficiency testing project was conducted among 48 microbiology laboratories participating in Project ICARE (Intensive Care Antimicrobial Resistance Epidemiology). All laboratories correctly identified the Staphylococcus aureus challenge strain as oxacillin- resistant and an Enterococcus faecium strain as vancomycin-resistant. Thirty-one (97%) of 32 laboratories correctly reported the Streptococcus pneumoniae strain as erythromycin-resistant. All laboratories testing the Pseudomonas aeruginosa strain against ciprofloxacin or ofloxacin correctly reported the organism as resistant. Of 40 laboratories, 30 (75%) correctly reported resistant MICs or zone sizes for the imipenem- and meropenem-resistant Serratia marcescens. For the extended-spectrum beta-lactamase (ESBL)-producing strain of Klebsiella pneumoniae, 18 (42%) of 43 laboratories testing ceftazidime correctly reported ceftazidime MICs in the resistant range. These results suggest that current testing generally produces accurate results, although some laboratories have difficulty detecting resistance to carbapenems and extended-spectrum cephalosporins. This highlights the need for monitoring how well susceptibility test systems in clinical laboratories detect emerging resistance.

Aminoglycosides↗