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A stepwise approach to the laboratory diagnosis of Buruli ulcer disease.

OBJECTIVE: In view of technical and financial limitations in areas of endemicity, the current practice and recommendations for the laboratory diagnosis of Buruli ulcer disease (BUD) may have to be reconsidered. We reviewed diagnostic results in order to explore options for a modified, more practicable, cost-effective and timely approach to the laboratory diagnosis of BUD. METHODS: Diagnostic specimens from 161 clinically diagnosed BUD patients from four different treatment centres in Ghana were subjected to laboratory analysis. The positivity rates of the laboratory assays were compared. RESULTS: The number of laboratory-confirmed clinically diagnosed BUD cases with one positive confirmative test was 20% higher than that with two positive confirmative tests. The specificity of microscopy (MIC) and PCR was 96.6% and 100%, respectively. Subsequent analysis of specimens from surgically excised pre-ulcerative tissue-by-tissue MIC and tissue PCR rendered 65% laboratory-confirmed BUD cases. Subsequent analysis of diagnostic swabs from ulcerative lesions by swab smear MIC and swab PCR rendered 70% of laboratory-confirmed BUD cases. CONCLUSIONS: The specificity of the diagnostic tests used in this study suggests that one positive diagnostic test may be considered sufficient for the laboratory confirmation of BUD. Subsequent application of different diagnostic tests rendered a laboratory confirmation of 65% pre-ulcerative and of 70% ulcerative lesions. Implementation of a stepwise, subsequent analysis of diagnostic specimens will result in considerable cost saving compared with simultaneous testing of specimens by several diagnostic assays.

Cost-Benefit Analysis↗

Laboratory monitoring of drugs at initiation of therapy in ambulatory care.

BACKGROUND AND OBJECTIVES: Product labeling and published guidelines reflect the importance of monitoring laboratory parameters for drugs with a risk of organ system toxicity or electrolyte imbalance. Limited information exists about adherence to laboratory monitoring recommendations. The objective of this study was to describe laboratory monitoring among ambulatory patients dispensed medications for which laboratory testing is recommended at therapy initiation. DESIGN AND SUBJECTS: We conducted a retrospective cross-sectional analysis of patients in 10 geographically distributed health maintenance organizations who were newly prescribed medications with recommended laboratory test monitoring. The main outcome measure was the proportion of initial drug dispensing without recommended baseline laboratory monitoring for 35 newly initiated drugs or drug classes. RESULTS: One hundred seven thousand, seven hundred sixty-three of 279,354 (39%) initial drug dispensings occurred without recommended laboratory monitoring. Patients without monitoring were younger than patients who had monitoring (median 57 vs 61 years, P<.001). Thirty-two percent of dispensings where a serum creatinine was indicated did not have it evaluated (range across drugs, 12% to 61%); 39% did not have liver function testing (range 10% to 75%); 32% did not have hematologic monitoring (range 9% to 51%); and 34% did not have electrolyte monitoring (range 20% to 62%) (P<.001). CONCLUSIONS: Substantial opportunity exists to improve laboratory monitoring of drugs for which such monitoring is recommended. This study emphasizes the need for research to identify the clinical implications of not conducting recommended laboratory monitoring, existing barriers to monitoring, and methods to improve practice.

Ambulatory Care↗

Environmental bias? Effects of housing conditions, laboratory environment and experimenter on behavioral tests.

Behavioral testing does not always yield similar results when replicated in different laboratories, and it usually remains unclear whether the variability in results is caused by different laboratory environments or different experimenters conducting the tests. In our study, we applied a systematic variation of housing conditions, laboratories and experimenters in order to test the influence of these variables on the outcome of behavioral tests. We wanted to know whether known effects of different housing conditions on behavior can be demonstrated regardless of the respective laboratory and experimenters. In this study, we compared the behavior of mice kept under enriched housing conditions with mice kept in unstructured cages regarding their exploratory, locomotor and anxiety-related behavior in the barrier test, in the open-field test and in the elevated plus-maze test. Experiments were conducted by six different persons in two different laboratories. In spite of an extensive protocol standardizing laboratory environment, animal maintenance and testing procedures, significant differences in absolute values between different laboratories as well as between different experimenters were noticed in the barrier test and in the elevated plus-maze test but not in the open-field test. However, with regard to the differences between enriched and unstructured housing conditions, overall consistent results were achieved by different experimenters in both laboratories. We conclude that the reliability of behavioral phenotyping is not challenged seriously by experimenter and laboratory environment as long as appropriate standardizations are met and suitable controls are involved.

Animals↗

Can the laboratory affect the investigation and diagnosis of primary biliary cirrhosis?

BACKGROUND: Primary biliary cirrhosis (PBC) is an autoimmune liver disease characterised by the presence of various laboratory abnormalities but the precise role of laboratory staff in initiating clinical referral and subsequent biopsy is not clear. OBJECTIVE: To examine the impact of laboratory abnormalities in the investigation of PBC. METHODS: In a retrospective study of laboratory results over nine years from 1996, computer records were reviewed to identify how many referrals for biopsy were initiated and subsequent diagnoses made as a result of clinical signs, raised serum alkaline phosphatase activity (ALP), raised IgM concentration, or positive mitochondrial antibodies accompanied by a clinical comment from the laboratory suggesting further action. RESULTS: 22 diagnoses of PBC were confirmed by histopathology. Eleven had high ALP activity which had follow up tests initiated by the laboratory (mitochondrial antibodies or IgM or both) and a comment added suggesting further investigation into the possibility of PBC. Seven had abnormal liver antibodies and one had a high polyclonal IgM concentration which prompted the relevant follow on testing and comments. One had an earlier diagnosis made on serological/clinical grounds and the biopsy was a confirmatory measure. One had no liver related antibodies. One had a request by laboratory staff for follow on tests but these were not asked for in subsequent samples by the requesting clinician. CONCLUSIONS: There is a positive role for laboratory staff in the diagnosis of PBC. Unexplained rises in ALP activity, positive mitochondrial antibodies, or raised IgM concentrations should be investigated more fully by laboratory staff and advice given to prompt a clinical referral for review and biopsy.

Adult↗

[A study on resistance of Mycobacterium tuberculosis to four first-line anti-tuberculosis drugs in Japan: comparison of results in the local facilities and in the reference laboratory, in 1997].

Five years after the last survey of drug-resistant tuberculosis in Japan, a nationwide survey was conducted by the Tuberculosis Research Committee (Ryoken). A total of 78 hospitals in various districts of Japan participated in this cooperative study. Each collaborating laboratory sent all the isolated mycobacterial cultures during June 1 to November 30, 1997 to the Research Institute of Tuberculosis (RIT), which is one of the Supranational Reference Laboratories of the WHO/IUATLD Global Project on Anti-tuberculosis Drug Resistance Surveillance. At RIT identification and drug susceptibility of Mycobacterium tuberculosis isolates were reexamined. The RIT received a total of 2,167 cultures. Among them, 523 cultures were excluded from further examinations because of various reasons, such as growth of mycobacteria other than tubercle bacilli (MOTT, 453), mixed cultures of M. tuberculosis and MOTT (16), and contamination or non-viability (54). Thus drug susceptibility test results were available for 1,644 cultures, including 47 from foreign-born people. In the local laboratories, the absolute concentration method using 1% Ogawa egg slant (standard method, 26 hospitals), its modified methods using a 48-well plate (Microtiter method, 29 hospitals) and a 16-well plate (Well-pack method, 7 hospitals), combination of above 2 or 3 methods (13 hospitals), and other method (3 hospitals) were used for drug susceptibility testing, and the proportion method using 1% Ogawa egg slant was used in the RIT. The results in the local laboratories were compared with those in the RIT. A high concordance rate (over 90%) was seen in the testing for 1 microgram/ml of isoniazid (INH), rifampin (RFP) and streptomycin (SM), but the rate was lower (under 90%) in the testing for 0.1 microgram/ml of INH and ethambutol (EMB). However, there was no significant difference in the concordance rates according to the test drugs among methods for drug susceptibility testing used in the local laboratories. Median concordance rates between the results with the standard method, Microtiter method and Well-pack method in the local laboratories, and those in the RIT were 95.9%, 93.2% and 96.4% respectively. Relatively lower concordance rates were seen in the laboratories using the Microtiter method related to high overestimation rates (median overestimation rate of 5.3%), compared with 1.2% and 2.3% in the laboratories using the standard method and Well-pack method, respectively. However, relatively lower concordance rates (less than 90%) were seen in the laboratories using any of the three methods, indicating that there are variations among facilities. Part of the results concerning the resistance patterns to four first-line anti-tuberculosis drugs were reported elsewhere.

Ethambutol↗

Second inter-laboratory study comparing endotoxin assay results from cotton dust.

Previously, a large two-part inter-laboratory round robin endotoxin assay study was completed. This first study showed that when cotton dust samples, which are practically identical, are assayed for endotoxin that the intra- laboratory results had a very small variation while intra-laboratory results of the sample had a very high variation. In the first part of the study, each laboratory followed its own in-house assay protocol; but in the second part of the study, when the extraction protocol was standardized, the inter-laboratory results showed a lower variation, which suggested that with further standardization, further reduction of differences between laboratories might be achieved in order that results between laboratories would become more comparable. The results stimulated interest in extending the study to include cotton dust with two levels of endotoxin, standardization of the extraction protocol, and using the same assay kit from the same production lot. The results of this second round robin endotoxin assay study indicate that differences between laboratories are still high, but most of the laboratories could discern the cotton dusts with the different levels of endotoxin.

Chemistry Techniques, Analytical↗

The history of the Laboratory of Pathology of the Cluj-Napoca Oncological Institute.

The Laboratory of Pathology of the actual "Professor Ion Chiricută" Oncological Institute of Cluj-Napoca, former "Iuliu Maniu" Institute for Cancer Study and Prophylaxis, had the privilege that in its framework carry on an important part of their activity professors Titu Vasiliu and Rubin Popa, who are forming, beside Victor Babeş, the golden trinity of the Romanian pathology. The Cancer Institute of Cluj, one of the first in the World, was founded in 1929, especially by the clear-sightedness and the efforts of Professor Iuliu Moldovan, the master of the modern Romanian school of hygiene. The clinic division was assisted by a Laboratory of Pathology, whose chief was appointed the young pathologist of high competence, Rubin Popa, associate Professor of this department of the Cluj School of Medicine. In 1942' he became director of the Institute, function accomplished until his premature disappearance in 1958. Titu Vasiliu worked in the Oncological Institute from 1949, a year after his forced retreat from the chair of pathology, up to 1958. Fortunately, his premature disappearance did not interrupt the activity of the laboratory, because the management of the Oncological Institute was committed to Ion Chiricută, an experimented and modern surgeon of Bucharest. From 1960, the Laboratory of Pathology has been led by Professor Augustin Mureşan, an experimented, rigorous and prudent pathologist, who has imprinted these indispensable qualities to his disciples learning under his leadership. The activity of the laboratory has been very favorably influenced by the presence of Professor Gheorghe Badenski from the Department of Microbiology. The collaboration with Professor Eugen Pora from Babeş-Bolyai Department of Animal Physiology and his disciples, Virgil Toma, Draga Nestor, Sena Roşculet, Carmen Stugren and Georgette Buga has carried on the performance of interesting works concerning the thymus involution in tumor-bearing hosts and its signification for the depressed immunity in the advanced stages of cancer. In the same direction, the behavior of mast cells has been studied in collaboration with Professor George Csaba from the Budapest Medical University, Department of Biology. The observations brought about were remarked by the Canadian scientist Hans Selye. Most of these works have been included in the book "Immunity and cancer", distinguished with "Victor Babeş" Prize of the Romanian Academy. The arrival in the Institute of Professor Ion Macavei, disciple of Iuliu Hatieganu and founder of the Clinical Hematology in Cluj, expert in blood and bone marrow cytology, has given a strong impulse to the studies of malignant hemopoietic diseases. The current use of cytologic and histopathologic examinations in this field of pathology and, especially, the introduction by him, for the first time in Romania, of the osteomedullary biopsy has permitted the elaboration of an appreciated work about the cytologic and histologic diagnosis of lymphadenopathies. In the histochemical-histoenzymatic period of the microscopic diagnosis, between the years 1960-1990, the laboratory has enjoyed by the advices and the material help of Professor Raymond Wegmann from the Paris University, Institute of Histochemistry, the founder-editor of the International Review of Histochemistry, from 1976, of Cellular and Molecular Biology, who visited our laboratory in 1992. From 1965, in an adjacent Laboratory of Cytogenetics, Corneliu D. Olinici has performed the first karyotypes in Cluj and has teached the method to several other specialists. Despite the technical difficulties, the works performed in the Laboratory of Pathology have succeeded sometimes to reach the quality required by Professor Chiricută to a valuable scientific work in cancerology. This performance has been obtained by a study concerning Crabtree effect variations in tumoral metastases or about lactic-dehydrogenase behavior in breast carcinomas.

Cancer Care Facilities↗

The relative value of consultation, questionnaires and laboratory investigation in the identification of excessive alcohol consumption.

Alcohol is a major cause of morbidity and mortality in Britain. Consultation, questionnaires and laboratory tests may all be used to help identify alcohol abuse and thereby prevent and treat alcohol-related problems. Consultation which can identify 80% of alcohol abusers involves recording the findings of alcohol and general histories and physical examination. The accuracy of the assessment depends on the reliability of the respondent and the respondent's relations and friends, and on the skill of the investigator; however, thorough assessment is time-consuming and expensive. Questionnaires may identify up to 80% of alcoholics. They are generally based on the Michigan Alcohol Screening Test and CAGE questionnaires and are simple, rapid to complete, inexpensive and not dependent on skilled investigators; however, the principal disadvantage of using questionnaires is that a personal relationship is not developed with the subject. Finally, simple and complex laboratory tests may be used. Of the simple laboratory tests, raised GGT or MCV levels are the most useful and when these values are combined, 90% of alcoholics may be identified correctly. Complex laboratory tests may exhibit greater sensitivity and specificity and provide useful additional information; however, their restricted availability limits their widespread use. The value of each of these methods depends on the objective of the assessment. For population surveys, questionnaires are of greatest relative value and consultation and laboratory tests may be used to confirm the presence of alcohol abuse. In general practice and the hospital setting, it is imperative to include questions on alcohol intake and alcohol-related problems in all interviews with patients. Laboratory tests may be used to confirm suspected alcohol abuse and questionnaires may provide useful screening tools. Finally, in the specialist alcohol unit, consultation, questionnaires and laboratory investigations are all important for identifying alcohol abuse. In this setting, consultation is of particular importance and the alcohol history and physical examination should be recorded by a skilled investigator and the results confirmed with relatives and close friends. Questionnaires are useful as initial screening or assessment tools and computer-based systems may facilitate data collection. Simple and complex laboratory tests may be used to confirm the diagnosis and help ascertain the extent of disease. By assuming that 'all patients have alcohol-related problems until proven otherwise', and through the appropriate application of consultation, questionnaires and laboratory tests, identification of excessive alcohol consumption and the prevention of its sequelae will be facilitated.

Alcoholism↗

A comparison of Newcastle disease hemagglutination-inhibition test results from diagnostic laboratories in the southeastern United States.

A two-phase comparison was conducted using the Newcastle disease hemagglutination-inhibition (HI) test to determine the variation of serologic results from poultry diagnostic laboratories in the southeastern United States. In the first phase of the comparison, most of the 17 participating laboratories in 10 states found the coded negative sera to be negative, and most found the potent sera to have the highest titers. However, there was a wide range of geometric mean titers (GMT's), from 2 to greater than or equal to 113 for the same serum samples. Each laboratory was strikingly consistent at reporting unknown but identical triplicate serum samples to have the same titer, even though the titers were frequently quite different from those of other laboratories. This observation indicated that currently used procedures yielded good reproducibility within individual laboratories but not necessarily between laboratories. In the second phase of the comparison, participants were furnished another set of coded sera, antigen, and a suggested incubation time. The implementation of the recommended incubation period reduced the extent of the lab-to-lab differences, but GMT's between labs still ranged from 11 to 95 on identical serum samples. When all laboratories used the same antigen, the average of the GMT results increased from 38 to 48, but the GMT's from the different laboratories ranged from 7 to more than 2048. Although the comparison exercise resulted in some improvement in uniformity, it was obvious that a continuing voluntary program should be initiated to certify laboratories and promote uniform test methods for specific serologic procedures using coded sera.

Animals↗

[A need for undergraduate education for laboratory medicine in medical schools].

Today, there are many problems to be solved in the curricula in the medical school education in Japan. Generally, the typical classical curriculum of the undergraduate studies in medical education is divided into two courses such as the basic and the clinical medicine. Recently, some schools, have adapted an integrated education program through a six school year course of studies including the two-year premedical course and introduced an early exposure system in clinical medicine. Department of Laboratory Medicine (Clinical Pathology) has a central medical laboratory where clinical practice tests, especially specimen tests, are performed by medical laboratory technicians trained in laboratory technology. The central laboratory system was introduced by the GHQ of the Allied Occupation Forces after World War II in Japan. This was first established in 1950 at the National Tokyo First Hospital. Afterwards, this system was adopted in almost all hospitals in Japan. Consequently, clinical testing was transferred from doctors to medical laboratory technicians and this practice brought a decrease in the doctor's level of the current knowledge or techniques of laboratory testing. Therefore, education in Laboratory Medicine in the medical schools, should be refocused to train medical students to be a clinician who understands the test principles, selects suitable tests and interprets the results, reduces the number of test(s) for clinical practice. This clinical training will be for the physical, mental and economic welfare of the patient. The actual changes of the curriculum which have been made with time for Laboratory Medicine at Tokushima University Medical School, are introduced and discussed.

Education, Medical, Undergraduate↗

[Problems on emergency laboratory tests for blood cell counts (BCC) and coagulation].

Emergency laboratory tests need to clarify sudden changes in disease conditions in inpatients and outpatients. Such tests are used for various purposes and at various times. In the department of Clinical Laboratory in Osaka City University Medical School Hospital, the emergency laboratory office was established and blood cell counts and coagulation tests are the hematological tests performed. Blood cell counts are performed throughout the day on weekdays and holidays, but coagulation tests are only performed from 9 am to 5 pm on weekday. Laboratory tests are requested using the ordering system with computer and laboratory results are shown on line. The number of emergency blood cell counts per year is approximately 23,539, accounting for about 20% of the number of routine blood cell counts each year, 14,561 (61.9%) on weekdays, 8,978 (38.1%) on holidays, 17,695 (75.2%) for inpatients and 5,844 (24.8%) for outpatients. The number of inpatients tested per year was 8,760 (49.5%) on holidays and 8,935 (50.5%) on weekdays. The number of outpatients tested per year was 5,626 (96.3%) on weekdays and 218 (3.7%) on holidays. Emergency laboratory tests will be more useful for large-scale hospitals in the future. The construction of an emergency laboratory system suitable for each hospital is important. Furthermore, the continuous improvement in emergency laboratory systems and greater advances in the quality of clinical laboratory test are necessary.

Blood Coagulation Tests↗

[Reliability of Amplicor Mycobacteria test for detection of Mycobacterium tuberculosis complex. M. avium and M. intracellulare: a cooperative study among 9 laboratories].

The Amplicor Mycobacteria, a PCR-based assay, is a rapid test for the detection of Mycobacterium tuberculosis, Mycobacterium avium and Mycobacterium intracellulare in clinical samples. To estimate the reliability and reproducibility of the method, a cooperative blind study was conducted among 9 laboratories. Materials used for testing consisted of 105 sputum and 30 water samples containing known numbers of M. bovis BCG, M. avium, M. intracellulare, and samples without bacteria. Only 2 out of the 9 laboratories correctly identified the presence or absence of mycobacterial DNA in all 135 samples. In sputum samples, 6 out of the 9 laboratories detected mycobacterial DNA in all positive samples, and 4 out of the 9 laboratories correctly reported the absence of DNA in the negative samples, indicating the need for good laboratory practice and development of reference reagents to monitor the performance of the whole study, including pretreatment of clinical samples. The main problem was lack of specificity rather than lack of sensitivity. From about half of the laboratories, false-positive results were reported, however, the ratio was below 6%; 1% (1/106 sputum samples) in 3 laboratories, 1.9% (2/105) in 2 laboratories, and 5.7% (6/105) in one laboratory, respectively. These results indicate that the Amplicor Mycobacteria is quite useful for a rapid diagnosis of tuberculosis.

DNA, Bacterial↗

An outbreak of Shigella dysenteriae type 2 among laboratory workers due to intentional food contamination.

CONTEXT: Shigella dysenteriae type 2 is rare in the United States, and outbreaks associated with this pathogen are uncommon. OBJECTIVE: To determine the magnitude and source of an outbreak of S dysenteriae type 2. DESIGN: Retrospective cohort. SETTING: Laboratory of a large medical center. PATIENTS: Case patients were identified as laboratory workers who had diarrhea on or after October 28 and a positive stool culture or temperature greater than 37.8 degrees C. Laboratory workers with diarrhea only were probable case patients. MAIN OUTCOME MEASURES: We interviewed laboratory staff and performed identification, serotyping, and pulsed-field gel electrophoresis on isolates from case patients, implicated food, and laboratory stock culture. RESULTS: From October 29 through November 1, a total of 12 (27%) of 45 laboratory staff developed severe, acute diarrheal illness; 8 had S dysenteriae isolated from stool and 4 were hospitalized. All case patients reported having eaten muffins or doughnuts placed in the staff break room on October 29. Pulsed-field gel electrophoresis showed stool isolates from 9 case patients were indistinguishable from S dysenteriae type 2 recovered from an uneaten muffin and from the laboratory's stock strain, a portion of which was missing. CONCLUSIONS: The source of the outbreak was most likely the laboratory's stock culture, which was used to contaminate the pastries. Results of this investigation underscore the need for adequate precautions to prevent inadvertent or intentional contamination from highly pathogenic laboratory specimens.

Adult↗

An assessment of the exposure of technicians working in a chemical laboratory for aromatic hydrocarbons at Neftochim, Burgas.

The average exposure to aromatic hydrocarbons per working shift of laboratory assistants at a chemical laboratory were measured. The laboratory is one of the service departments for four different production departments at Neftochim, Burgas--the largest oil refinery in Bulgaria. Long-term sampling of the air from different workplaces in the laboratory was performed by sampling charcoal sorbent tubes (type CT-CN-2), manufactured by Higitest (type NIOSH). The concentration of benzene, toluene, ethyl benzene, xylene and isopropyl benzene in the air at the laboratory was determined by gas chromatography using the Varian MEGA 1 with a flame ionisation detector and Inowax capillary column. The measured exposure levels of toxic substances in the aromatic hydrocarbons analysis laboratory were as follows: Benzene, 0.15-1.3 mg/m3, in single samples its concentration was 4.06-8.63 mg/m3; toluene, 0.15-0.46 mg/m3, in single samples its concentration was 5.5-15.62 mg/m3; ethyl benzene in most samples was 0.02 mg/ m3, in single samples its concentration was 20.68 mg/m3; xylene in most samples was 0.4 mg/m3, in single samples its concentration was 0.51-1.68 mg/m3; isopropyl benzene in most samples was 0.1 mg/m3, in single samples its concentration was 0.20-1.12 mg/m3. The results, obtained by measuring the average work-shift exposure of laboratory assistants to aromatic hydrocarbons in the air at the analytical laboratories, show that the measured concentrations are smaller than the respective threshold limit values. Bearing in mind, however, that some of these substances have an effect on the human organism, exposure to them is excessively hazardous for laboratory technicians.

Bulgaria↗

Laboratory practice at the periphery in developing countries.

An effective national health service structure requires a comprehensive programme for primary health care in peripheral and rural areas. This is especially important in under-resourced countries where facilities are sparse, the population is widely dispersed and transport is limited. Haematology has a key role in diagnosis and patient management by selecting tests for their clinical relevance and utility for the specific circumstances, and ensuring their technical reliability when used in health clinics and point-of-care testing. WHO has proposed a basic menu of tests in three categories: (a) tests such as haemoglobin screen which can be performed by nurses, midwives, health-aides or community doctors, (b) tests such as haemoglobinometry, microhaematocrit and microscopic examination of stained preparations which can be performed by a technician or laboratory assistant in a health centre, (c) tests requiring greater technical expertise of a laboratory technician or trained doctor. The peripheral health clinics and district laboratories must be familiar with the guidelines on standardized methods for collecting and storing specimens and transporting them to a regional laboratory or a reference centre. A training syllabus should be provided at the health centres and district laboratories, and this should include on-site instruction from supervisors and access to training manuals and distance-learning material. A co-ordinated programme of quality assurance and standardization of test methods should be established by a reference centre or national health authority with a network which encompasses all laboratories and health clinics undertaking any tests. Each regional laboratory should foster lower level laboratories or clinics within its neighbourhood. Of particular concern is the reliable diagnosis and management of anaemia. WHO reports indicate that 40% of the world population suffer from anaemia, especially affecting pregnant women, and a high proportion of infants and children in developing countries. The Haemoglobin Colour Scale (HCS) was recently developed for WHO as a simple, cheap and portable device which reads haemoglobin within 1 g/dl of the true value. It has been validated in a number of studies and is now manufactured commercially in accordance with WHO specifications under control of a WHO Collaborating Centre. It has an important potential role in the resource-limited environment where anaemia screening presently usually depends on unreliable clinical examination.

Anemia↗

Analytical quality goals and assessment to ensure transferability of laboratory results.

About 3 years ago NORDKEM started a project entitled 'Medical Need for Quality Specifications in Clinical Laboratories'. This communication describes the general approach of this project and a subproject oriented towards problems of transferability of clinical laboratory data. Attempts are made to estimate clinical goals for analytical measurements--either used alone or in combinations with other measurements or observations--in defined clinical situations. Various methodologies are used for the assessment of the clinical goals, starting, e.g., from clinical situations or biological reference data. The analytical quality specifications are expressed as total allowable errors. It is necessary to complement specifications of 'clinical goals' with data describing characteristics of the measurement procedure, preanalytical errors and internal and external quality assurance procedures in order to establish the laboratory quality specification guaranteed by the laboratory. Problems of transferability of clinical laboratory results occur both within a laboratory/hospital and between laboratories/hospitals/health care units, problems that sometimes make communication of laboratory results difficult or even meaningless. In order to study the transferability of clinical laboratory data within a health care region, so called 'transformation functions' could be used to characterize each laboratory in a strict quality assessment/proficiency testing procedure on the basis of analytical quality specifications. Under certain conditions, e.g. for analytical procedures with high specificity and documented stable analytical performance, numerical correction of analytical bias could be performed to decrease interlaboratory variation to a level specified by medical needs.

Cholesterol↗

Has compliance with CLIA requirements really improved quality in US clinical laboratories?

BACKGROUND: The Clinical Laboratory Improvement Amendments of 1988 (CLIA'88) mandate universal requirements for all U.S. clinical laboratory-testing sites. The intent of CLIA'88 is to ensure quality testing through a combination of minimum quality practices that incorporate total quality management concepts. These regulations do not contain established, objective indicators or measures to assess quality. However, there is an implicit assumption that compliance with traditionally accepted good laboratory practices--following manufacturers' directions, routinely analysing quality control materials, applying quality assurance principles, employing and assessing competent testing personnel, and participating in external quality assessment or proficiency testing (PT)--will result in improved test quality. METHODS: The CLIA'88 regulations do include PT performance standards, which intentionally or unintentionally, define intra-laboratory performance. Passing PT has become a prime motivation for improving laboratory performance; it can also be used as an objective indicator to assess whether compliance to CLIA has improved intra-laboratory quality. RESULTS: Data from 1994 through 2002 indicate that the percentage of laboratories passing PT has increased. In addition to PT performance, subjective indicators of improved quality--frequency of inspection deficiencies, the number of government sanctions for non-compliance, and customer satisfaction--were evaluated. CONCLUSIONS: The results from these subjective indicators are more difficult to interpret but also seem to show improved quality in US clinical laboratories eleven years post-CLIA'88.

Clinical Laboratory Techniques↗

IVD industry role for quality and accreditation in medical laboratories.

Manufacturers of in vitro diagnostic (IVD) medical devices and laboratory management have become integral partners in building and improving the quality of laboratory services. There is an increasing awareness that quality is inherent in the design of any reagent or analytical system. In vitro diagnostic medical devices should provide patients, users and third parties with a high level of health protection. Therefore, both manufacturers and users must work in partnership for continual improvement. For manufacturers, standards such as ISO 9000 already exist to guide applications of quality practices. In the field of laboratory medicine, the availability of a specific, universal standard (ISO/DIS 15189) for quality management in medical laboratories will represent a great opportunity for harmonising medical laboratories at an international level. In addition, accreditation of medical laboratories according to the proposed ISO 15189 standard can help develop the relationships between laboratories, and the biological follow-up of travelling patients. Manufacturers are able to help laboratory management to reach a high level of quality, not only by providing high value products, but also on the basis of their own experience of ISO 9000 certification.

Accreditation↗