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PubMed1997

Laboratory policies and practices for the genetic testing of children: a survey of the Helix network.

In order to discover whether laboratories have policies regarding the testing of unaffected children, we surveyed all laboratories registered with Helix, a national net-work of DNA diagnostic laboratories. Of 186 laboratories asked to respond anonymously to a four-page questionnaire, 156 (84%) replied. A screening question removed 51 laboratories that provided no clinical services. Of the remaining 105, 92% said that their requisition forms asked the person's age. Substantial minorities had policies for the testing of minors for late-onset disorders (46%), for carrier status for recessive disorders (33%), or for disorders for which the test offers no medical benefit within 3 years (33%). Most laboratories are responsive to parental requests. For 12 of 13 late-onset disorders, the majority of laboratories that offered testing had had requests to test children. The majority had tested healthy children, <12 years of age, for eight disorders. Approximately 22% had tested children, <12 years of age, for Huntington disease. Majorities had received requests to test healthy children for carrier status for 10 of 15 recessive or X-linked disorders and had tested children, <12 years of age, for 6 of these disorders, including cystic fibrosis, hemophilia A, fragile X syndrome, and Duchenne muscular dystrophy. Approximately 45% of the laboratories occasionally had provided tests directly to consumers. In view of the possibility that the harms of presymptomatic diagnoses of children sometimes may outweigh the benefits, our results suggest a need for consistent laboratory policies designed for the best interests of the child and the family.

Adolescent↗
PubMed2003

Antimicrobial proficiency testing of National Nosocomial Infections Surveillance System hospital laboratories.

OBJECTIVE: The National Nosocomial Infections Surveillance (NNIS) System personnel report trends in antimicrobial-resistant pathogens. To validate select antimicrobial susceptibility testing results and to identify test methods that tend to produce errors, we conducted proficiency testing among NNIS System hospital laboratories. SETTING: NNIS System hospital laboratories in the United States. METHODS: Each laboratory received five organisms (ie, an imipenem-resistant Serratia marcescens, an oxacillin-resistant Staphylococcus aureus, a vancomycin-resistant Enterococcus faecalis, a vancomycin-intermediate Staphylococcus epidermidis, and an extended-spectrum beta-lactamase (ESbetaL)-producing Klebsiella pneumoniae). Testing results were compared with reference testing results from the Centers for Disease Control and Prevention. RESULTS: Of 138 laboratories testing imipenem against the Serratia marcescens strain, 110 (80%) correctly reported minimum inhibitory concentrations (MICs) or zone sizes in the resistant range. All 193 participating laboratories correctly reported the Staphylococcus aureus strain as oxacillin resistant Of the 193 laboratories, 169 (88%) reported correct MICs or zone sizes for the vancomycin-resistant Enterococcus faecalis. One hundred sixty-two (84%) of 193 laboratories demonstrated the ability to detect a vancomycin-intermediate strain of Staphylococcus epidermidis, however, disk diffusion performed poorly when testing both staphylococci and enterococci with vancomycin. Although laboratory personnel correctly reported nonsusceptible extended-spectrum cephalosporins and aztreonam results for K. pneumoniae, only 98 (51%) of 193 correctly reported this organism as an ESbetaL producer. CONCLUSION: Overall, NNIS System hospital laboratory personnel detected most emerging resistance patterns. Disk diffusion continues to be unreliable for vancomycin testing of staphylococci and must be used cautiously for enterococci. Further education on the processing of ESbetaL-producing organisms is warranted.

Bacteria↗
PubMed2003

Harmonization of antimicrobial susceptibility testing among veterinary diagnostic laboratories in the five Nordic countries.

A total of 100 bacterial strains (25 Escherichia coli, 25 Salmonella enterica, 25 Staphylococcus aureus, and 25 Enterococcus strains) and four reference strains were tested for susceptibility toward 8-12 antimicrobial agents in 12 veterinary diagnostic laboratories in the five Nordic countries using routine methodology. In addition, the 25 Enterococcus strains were identified to species level. A total of 22,598 (97.2%) out of 23,259 test results were in accordance when the data were categorized as susceptible or resistant. When the reported results were categorized according to the National Committee of Clinical Laboratory Standards breakpoints, the percentage of concordant results increased to 98.4% and the performance between laboratories varied between 94.2 and 99.4% concordant results. For E. coli, S. aureus, and Salmonella, all laboratories except one had more than 97% concordant results, whereas for Enterococcus spp., two laboratories had less than 90% concordant results. Susceptibility testing of Salmonella to fluoroquinolones gave rise to almost 0.5% nonconcordant results and susceptibility testing of S. aureus to vancomycin resulted in that 1.8% of the strains were incorrectly reported as vancomycin resistant. Ten laboratories identified the Enterococcus spp. to species level. All five Enterococcus faecium and 10 Enterococcus faecalis selected from the strain collection at the Danish Veterinary Institute were correctly identified by all laboratories, whereas some problems were observed identifying other enterococcal species. This study showed a good performance and agreement in antimicrobial susceptibility testing at the 12 participating laboratories and that surveillance data covering susceptibility test results of E. coli, S. aureus, and Salmonella from animals in the Nordic countries are comparable. But it also showed that some aspects can be improved. In addition, the study showed that the different laboratories are capable of identifying E. faecalis and E. faecium.

Drug Resistance, Bacterial↗
PubMed1988

Serological evidence of hantavirus infection in laboratory rats and personnel.

Laboratory-acquired haemorrhagic fever with renal syndrome (HFRS) has been reported in many countries. A serological survey of laboratory white rats and of laboratory personnel for antibodies to hantaviruses was conducted in Singapore. Forty-four per cent (143/329) of rats were seropositive by the indirect immunofluorescent antibody test but none had hantaviral antigens in lung tissues. Two of 74 laboratory personnel were seropositive but neither had a history of clinical illness. The high seropositivity rate among laboratory rats led to their replacement with Hantaan virus-free strains. To eliminate the hazard of laboratory-acquired HFRS, regular serological screening of laboratory rats and replacement of infected animals with seronegative stocks should be implemented. High risk techniques with laboratory rats, which are likely to generate aerosols, should be performed in biological safety cabinets. Serological surveillance of laboratory personnel and reporting of suspected HFRS cases are useful in the early detection of hantavirus infection.

Animals↗
PubMed1998

Laboratory values improve predictions of hospital mortality.

OBJECTIVE: To compare the precision of risk adjustment in the measurement of mortality rates using: (i) data in hospitals' electronic discharge abstracts, including data elements that distinguish between comorbidities and complications; (ii) these data plus laboratory values; and (iii) these data plus laboratory values and other clinical data abstracted from medical records. DESIGN: Retrospective cohort study. SETTING: Twenty-two acute care hospitals in St Louis, Missouri, USA. STUDY PARTICIPANTS: Patients hospitalized in 1995 with acute myocardial infarction, congestive heart failure, or pneumonia (n = 5966). MAIN OUTCOME MEASURES: Each patient's probability of death calculated using: administrative data that designated all secondary diagnoses present on admission (administrative models); administrative data and laboratory values (laboratory models); and administrative data, laboratory values, and abstracted clinical information (clinical models). All data were abstracted from medical records. RESULTS: Administrative models (average area under receiver operating characteristic curve=0.834) did not predict death as well as did clinical models (average area under receiver operating characteristic curve=0.875). Adding laboratory values to administrative data improved predictions of death (average area under receiver operating characteristic curve=0.860). Adding laboratory data to administrative data improved its average correlation of patient-level predicted values with those of the clinical model from r=0.86 to r=0.95 and improved the average correlation of hospital-level predicted values with those of the clinical model from r=0.94 for the administrative model to r=0.98 for the laboratory model. CONCLUSIONS: In the conditions studied, predictions of inpatient mortality improved noticeably when laboratory values (sometimes available electronically) were combined with administrative data that included only those secondary diagnoses present on admission (i.e. comorbidities). Additional clinical data contribute little more to predictive power.

Clinical Laboratory Information Systems↗
PubMed2003

Laboratory issues: use of nutritional biomarkers.

Biomarkers of nutritional status provide alternative measures of dietary intake. Like the error and variation associated with dietary intake measures, the magnitude and impact of both biological (preanalytical) and laboratory (analytical) variability need to be considered when one is using biomarkers. When choosing a biomarker, it is important to understand how it relates to nutritional intake and the specific time frame of exposure it reflects as well as how it is affected by sampling and laboratory procedures. Biological sources of variation that arise from genetic and disease states of an individual affect biomarkers, but they are also affected by nonbiological sources of variation arising from specimen collection and storage, seasonality, time of day, contamination, stability and laboratory quality assurance. When choosing a laboratory for biomarker assessment, researchers should try to make sure random and systematic error is minimized by inclusion of certain techniques such as blinding of laboratory staff to disease status and including external pooled standards to which laboratory staff are blinded. In addition analytic quality control should be ensured by use of internal standards or certified materials over the entire range of possible values to control method accuracy. One must consider the effect of random laboratory error on measurement precision and also understand the method's limit of detection and the laboratory cutpoints. Choosing appropriate cutpoints and reducing error is extremely important in nutritional epidemiology where weak associations are frequent. As part of this review, serum lipids are included as an example of a biomarker whereby collaborative efforts have been put forth to both understand biological sources of variation and standardize laboratory results.

Behavior↗
PubMed1992

Outbreaks of summer rotavirus linked to laboratory practices. The National Rotavirus Surveillance System.

In temperate regions rotavirus diarrhea is a disease of the cooler months of the year, but little is known about its patterns in the summer. We report on the first year of national surveillance of rotavirus, during which we actively investigated patterns of summer activity. We obtained data on rotavirus testing from 85 laboratories in 48 states, conducted a survey of their testing practices and retested for confirmation positive specimens from laboratories reporting high rates of positivity during the summer. During 1989 participating laboratories reported 4011 specimens tested for rotavirus during July and August, of which 436 (11%) were said to be positive. Most laboratories reported low rates of positivity during these months (median percent positive, 3), but five had very high rates of summer positivity (> 30%). These five laboratories were geographically separated, and neighboring laboratories showed little rotavirus activity. Positive specimens submitted by four of these centers with high rates of summer rotavirus could not be confirmed. A survey of laboratory methods found one commercial assay (TestPack) and two laboratory practices (failure to use controls and involvement of more than six technicians in the testing process) to be associated with high rates of summer positivity. Moderate rates of positivity (11 to 30%) were fond frequently in the southwest during July and August; reference testing of specimens from these laboratories confirmed positivity.(ABSTRACT TRUNCATED AT 250 WORDS)

Clinical Laboratory Techniques↗
PubMed2006

A laboratory intercomparison of radon in water measurements in Maine.

Naturally occurring radon exists in ground water and drinking water supplies. Many water testing laboratories provide measurements of radon in water for the public. No known national intercomparison program exists to verify the accuracy of the laboratories measuring radon in water in Maine or the Northeast. In recognition of this situation, the State of Maine Radiation Control Program sanctioned an intercomparison study for laboratories registered in Maine to measure radon in water. The University of Maine supplied each laboratory with water samples of various radon concentrations, served as the reference laboratory, and analyzed the results. Of the nine participating laboratories, eight use the liquid scintillation method while the ninth uses the E-PERM method to measure radon in water. Presented here are the results of this intercomparison study with a tabulation of the materials and methods used by the laboratories. The results from five of the nine testing laboratories showed significant discrepancies with those of the reference laboratory, typically due to low measurements.

Laboratories↗
PubMed2006

Laboratory versus portable sleep studies: a meta-analysis.

OBJECTIVE: The objective of this meta-analysis study was to compare the accuracy of home sleep studies with laboratory polysomnography in the diagnosis of obstructive sleep apnea (OSA). METHODS: Eligible studies included prospective cohort studies of portable and in-laboratory sleep studies performed on the same groups of patients. A comparison of respiratory disturbance index (RDI), mean low oxygen saturation levels, sleep time, rate of inadequate studies, and average cost per examination was made between portable and in-laboratory sleep studies. A total of 18 papers were identified in two independent Medline searches. RESULTS: RDI values on portable sleep studies were 10% lower on average compared with laboratory studies (odds ratio [OR], 0.90; 95% confidence interval [CI], 0.87-0.92). There was no significant difference in the mean low oxygen saturation on portable versus laboratory studies (OR, 1.0; 95% CI, 0.94-1.10). Recorded sleep time was significantly higher by 13% for laboratory compared with portable studies (OR, 0.87; 95% CI, 0.86-0.89), and portable studies were significantly more likely to give a poor recording when compared with laboratory examinations (P = .0001). The cost of home studies ranged from 35% to 88% lower than laboratory studies across a number of countries. CONCLUSION: Home sleep studies provide similar diagnostic information to laboratory polysomnograms in the evaluation of sleep-disordered breathing but may underestimate sleep apnea severity. The lower cost of home sleep studies makes it a viable screening tool for patients with suspected OSA; however, these lower costs are partially offset by the higher rate of inadequate examinations.

Cohort Studies↗
PubMed1996

Changing practices in mycobacteriology: a follow-up survey of state and territorial public health laboratories.

The resurgence of tuberculosis, which includes an increase in the isolation of multidrug-resistant strains of Mycobacterium tuberculosis, emphasizes the need for more rapid laboratory testing for identification of the etiological agent of the disease. In December 1991, state and territorial public health laboratories were surveyed to determine the methods that they were using for testing and reporting of M. tuberculosis. A follow-up survey was conducted in June 1994 to measure changes in the testing and reporting practices that had occurred as a result of efforts focused on the disease and on laboratory improvement. Completed questionnaires were received from 51 of 55 laboratories. Comparative data indicate that the proportion of laboratories reporting testing results within the number of days recommended by the Centers for Disease Control and Prevention has increased. Starting from the time at which the laboratory receives the specimen, the proportion of laboratories reporting the results of microscopic smear examination within the recommended 24 h has increased from 52.1 to 77.6%; the proportion reporting isolation and identification within 21 days has increased from 22.1 to 72.9%; and the proportion reporting results of isolation, identification, and drug susceptibility testing within 28 days has increased from 16.7 to 48.9%. Use of the recommended rapid testing methods has also increased: the proportion of laboratories using fluorescence staining for acid-fast microscopy has increased from 71.4 to 85.7%, the proportion using BACTEC for primary culture has increased from 27.1 to 79.6%, the proportion using rapid methods for M. tuberculosis identification has increased from 74.5 to 100.0%, and the proportion using BACTEC for primary drug susceptibility testing has increased from 26.2 to 73.3%. By implementing the recommended methods for M. tuberculosis testing and reporting, state and territorial public health laboratories are now able to transmit results to physicians more rapidly.

Follow-Up Studies↗
PubMed2002

False-positive mycobacterium tuberculosis cultures in 44 laboratories in The Netherlands (1993 to 2000): incidence, risk factors, and consequences.

False-positive Mycobacterium tuberculosis cultures are a benchmark for the quality of laboratory processes and patient care. We studied the incidence of false-positive cultures, risk factors, and consequences for patients during the period from 1993 to 2000 in 44 peripheral laboratories in The Netherlands. The national reference laboratory tested 8,889 M. tuberculosis isolates submitted by these laboratories. By definition, a culture was false positive (i) if the DNA fingerprint of the isolate was identical to that of an isolate from another patient processed within 7 days in the same laboratory, (ii) if the isolate was taken from a patient without clinical signs of tuberculosis, and/or (iii) if the false-positive test result was confirmed by the peripheral laboratory and/or the public health tuberculosis officer. We identified 213 false-positive cultures (2.4%). The overall incidence of false-positive cultures decreased over the years, from 3.9% in 1993 to 1.1% in 2000. Laboratories with false-positive cultures more often processed less than 3,000 samples per year (P < 0.05). Among 110 patients for whom a false-positive culture was identified from 1995 to 1999, we found that for 36% of the patients an official tuberculosis notification had been provided to the appropriate public health services, 31% of the patients were treated, 14% of the patients were hospitalized, and a contact investigation had been initiated for 16% of the patients. The application of DNA fingerprinting to identify false-positive M. tuberculosis cultures and the provision of feedback to peripheral laboratories are useful instruments to improve the quality of laboratory processes and the quality of medical care.

Bacteriological Techniques↗
PubMed2003

Proficiency testing program for clinical laboratories performing antifungal susceptibility testing of pathogenic yeast species.

Antifungal susceptibility testing is expected to facilitate the selection of adequate therapy for fungal infections. The general availability of antifungal susceptibility testing in clinical laboratories is low, even though a number of standard methods are now available. The objective of the present study was to develop and evaluate a proficiency testing program (PTP) for the antifungal susceptibility testing of pathogenic yeasts in laboratories licensed by the New York State Department of Health. A number of quality control standards, and methods for documenting laboratory performance, were developed in consultation with the laboratory directors. The participating laboratories were provided with five American Type Culture Collection strains of pathogenic yeasts for which the minimum inhibitory concentrations (MICs) of amphotericin B and fluconazole were well defined. A majority of laboratories (14 of 17) used broth microdilution, and these were evenly split between the NCCLS M-27A protocol and the Sensititre YeastOne method. The other three laboratories performed susceptibility testing with Etest. Overall, the levels of agreement between MIC reference ranges and the reported MICs were 85 and 74% for amphotericin B and for fluconazole, respectively. All laboratories except one successfully detected fluconazole resistance in a Candida krusei strain. However, amphotericin B resistance in a Candida lusitaniae strain was not detected by any of the participating labs. It is concluded that a suitably designed PTP could adequately monitor the competence of clinical laboratories performing antifungal susceptibility testing.

Antifungal Agents↗
PubMed2006

Audit of laboratory mycology services for the management of patients with fungal infections in the northwest of England.

BACKGROUND: Fungal infection is increasingly recognised as an important cause of morbidity and mortality, especially in immunocompromised patients. Little information exists on laboratory services available and the methods used by general microbiology laboratories to diagnose these important infections. AIM: To investigate the services microbiology laboratories in northwest England provide towards the diagnosis and management of superficial and deep fungal infections. METHODS: A questionnaire was sent to laboratories to get a holistic view of the support given to clinicians looking after patients with fungal infections. The aim was not to investigate details of each laboratory's standard operating procedures. The completed questionnaires, which formed the basis of this report, were returned by all 21 laboratories which were recruited. This study was conducted between March 2004 and September 2004. RESULTS: Services were provided to District General Hospitals and to six tertiary centres, including eight teaching hospitals by 16 laboratories. Their bed capacity was 250-1300 beds. Total specimens (including bacterial and viral) processed annually were 42 000-500,000 whereas fungal ones were 560-5400. CONCLUSION: In most microbiology laboratories of northwest England, clinicians were aware of the potential of fungal pathogens to cause infections especially in immunocompromised patients. Additional measures such as prolonged incubation of samples were introduced to improve fungal yield from patients at high risk. It is necessary to train and educate laboratory and medical staff about the role of serology and molecular methods in diagnosis and management of patients with fungal infection.

Dermatomycoses↗
PubMed2006

Identification of factor inhibitors by diagnostic haemostasis laboratories: a large multi-centre evaluation.

We have assessed the proficiency of diagnostic haemostasis facilities to correctly identify coagulation factor abnormalities and inhibitors. Forty-two laboratories participating in the external Quality Assurance Program (QAP) conducted by the RCPA agreed to participate and were each sent a set of eight samples (each 3 x 1 ml) for evaluation. They were asked to blind test these samples for the presence or absence of inhibitors, and where identified, to perform further analysis (including specific inhibitor analysis). In order to make the exercise more challenging, in addition to true factor inhibitors, samples were provided that reflected potential pre-analytical variables that might arise and complicate inhibitor detection or lead to false inhibitor identification. In brief, the sample set comprised a true high level factor (F) V inhibitor, a true moderate level FVIII inhibitor (but sample was defibrinogenated), a true lupus anticoagulant (LA), a normal (but slightly aged) plasma sample, a normal serum sample, a normal EDTA sample, an oral anticoagulant/vitamin K deficiency sample, and a gross heparin ( approximately 10 U/ml) contaminated sample. Sixty-three percent of participants correctly identified the true FV inhibitor as such, although the reported range varied greatly [10 to >250 Bethesda units (BU/ml)] and 46% correctly identified the true FVIII inhibitor, despite the complication of the sample presentation, although the reported range also varied (7 to 64 BU/ml). Some laboratories either failed to identify the inhibitor present, or misidentified the inhibitor type. The LA, the oral anticoagulant/vitamin K deficiency, the normal serum sample, and the normal (aged) sample were also correctly identified by most laboratories, as was the absence of specific factor inhibitors in these samples. However, a small subset of laboratories incorrectly identified the presence of specific factor inhibitors in some of these samples. The heparin sample was also correctly identified by most (68%) laboratories. In contrast, the normal EDTA sample was misidentified as a FV and/or FVIII inhibitor by most (68%) laboratories, and only one laboratory correctly identified this as an EDTA sample. Thus, we conclude that although laboratories are able, in most cases, to identify the presence of true factor inhibitors, there is a large variation in identified inhibitor levels and there are also some significant errors in identification (i.e. false negatives and misidentifications). In addition, there is a significant false positive error rate where some laboratories will identify the presence of specific factor inhibitors where no such inhibitor exists (i.e. false positives).

Blood Coagulation Factors↗
PubMed2006

HER2 testing by local, central, and reference laboratories in specimens from the North Central Cancer Treatment Group N9831 intergroup adjuvant trial.

PURPOSE: To evaluate concordance between local and central laboratory HER2 testing results in patients from the North Central Cancer Treatment Group (NCCTG) N9831 adjuvant trial of trastuzumab. PATIENTS AND METHODS: NCCTG N9831 is a randomized, phase III clinical trial comparing three drug regimens: doxorubicin/cyclophosphamide followed by paclitaxel with trastuzumab added concurrently, sequentially, or not at all as adjuvant therapy for women with HER2-positive resected breast cancer. Originally, patients were eligible if their tumors were HER2 positive by either local laboratory immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH). A protocol modification in 2002 made central laboratory testing mandatory, with additional testing of discordant cases conducted by a reference laboratory. Concordance between local and central laboratory, and level of agreement between central and reference laboratory HER2 findings in discordant cases were examined. RESULTS: HER2 positivity was confirmed in 85.8% of 2,535 patients registered since March 2002. When local and central evaluation used the same methodology, concordance was 88.1% for FISH and 81.6% for a diagnostic test for presence of the HER2 protein. Among discordant cases examined at the reference laboratory, there was 94.3% agreement for IHC (0, 1+, 2+) and 95.2% agreement for FISH (not gene amplified). CONCLUSION: There was a high degree of discordance between local and central testing for IHC and FISH, but a high degree of agreement between central and reference laboratories. These findings support the importance of using high-volume, experienced laboratories for HER2 testing to improve the process of selecting patients likely to benefit from trastuzumab therapy.

Antibodies, Monoclonal↗
PubMed2005

Japanese standard reference material for JDS Lot 2 haemoglobin A1c. I: Comparison of Japan Diabetes Society-assigned values to those obtained by the Japanese and USA domestic standardization programmes and by the International Federation of Clinical Chemistry reference laboratories.

BACKGROUND: The Committee on Standardization of Laboratory Testing Related to Diabetes Mellitus of the Japan Diabetes Society (JDS) previously recommended use of the primary calibrator (JDS Lot 1) prepared by the former Committee for Standardization of Glycohemoglobin for standardizing the measurement of haemoglobin A1c (HbA1c). Owing to the depletion of vials of Lot 1 in March 2001, the present committee certified a new reference material, Lot 2, now distributed by the Health Care Technology Foundation (HECTEF). The standardization programme for HbA1c measurement in Japan is currently based on Lot 2, which has values assigned from within Lot 1; the Lot 1 values were consensus values based on assays by laboratories in the Japanese national quality control programme. In this study, for the purpose of international comparison and standardization, Lot 2 was assayed by the JDS reference laboratories, the National Glycoprotein Standardization Program (NGSP) in the USA, and by reference laboratories approved by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). METHOD: The HbA1c values of JDS Lot 2 were transferred from those assigned to Lot 1 using KO500, a high-resolution HPLC method, at three laboratories approved by the JDS committee. Subsequently, vials of JDS Lot 2 were shipped to and assayed by the NGSP in the USA and 10 IFCC reference laboratories. RESULT: The JDS-assigned HbA1c values (from Lot 1) are 4.04 for Level 1, 5.38 for Level 2, 7.32 for Level 3, 9.88 for Level 4, and 12.63 for Level 5, all expressed as a percentage of total haemoglobin. The values obtained by NGSP and the IFCC laboratories gave the following formulas: NGSP value(%)=JDS value(%)+0.3%; IFCC value(%)=1.068xJDS value(%)-1.741%. CONCLUSION: Although the values obtained by the IFCC laboratories are significantly lower than the values assigned to Lot 2 by the JDS, the relationship is linear. In addition, standardization of HbA1c based on JDS Lot 2 is currently at a satisfactory level in Japan. As a result, the reassignment of values for Lot 2 to agree with the IFCC values should be relatively easy and will be done after all relevant parties agree to the change.

Blood Chemical Analysis↗
PubMed2004

Generic scheme for independent performance assessment in the molecular biology laboratory.

BACKGROUND: A variety of proficiency testing schemes are available for specific molecular analyses, but there is an acute need for more widely accessible schemes to assess and demonstrate general competence in DNA analysis. METHODS: Fifteen laboratories, including academic, clinical, and commercial organizations, were recruited into the prototype assessment exercise. A range of test samples were provided, and participants were required to extract DNA from simple matrices, perform PCR amplification, and score the samples as positive or negative by electrophoretic analysis of the amplification products. Results were requested as both gel images and a completed results table, and the performance of each laboratory was then scored on the submitted analytical results. RESULTS: Overall, laboratories performed the analysis successfully, with participants scoring a high proportion of the samples correctly in the two rounds of the scheme. However, not all of the laboratories were able to achieve amplification for all samples, and the performance of some laboratories was not consistent in the two rounds. In addition, several analytical problems were encountered at all stages of the process, including DNA extraction, PCR amplification, and correct recording of results. CONCLUSIONS: The generic approach described here has enabled effective cross-sectoral benchmarking of laboratories from a variety of analytical sectors. The problems encountered by some participating laboratories highlight the need for quality control and checks at all stages of the process to ensure accuracy of results. A statistical analysis of the results (ANOVA) allowed meaningful comparison of the consistency and sensitivity achieved by laboratories, demonstrating that an effective balance was achieved between the level of data obtained from laboratories and the time expenditure required from participants.

Chemistry, Clinical↗
PubMed1998

Concepts for a model of good medical laboratory services.

Several international standards and corresponding interpretation documents for quality management systems have been published. Although these standards are found useful to some extent, they are considered to be insufficient in several areas important for medical laboratories particularly in the pre- and post-examinational phases. The normative document for accreditation of laboratories (ISO/IEC Guide 25) is presently being revised and a document for medical laboratories (ISO/TC 212, CD 15189) is at draft stage. Both aim to include aspects of total quality management. The concept of total quality management is rather vague. Generally, its goal has been defined as "business excellence". This term, however, needs some explanation if applied to medical laboratories. Therefore, a project group of the European Confederation of Laboratory Medicine (ECLM) has developed a model for total quality management, which is based on a comprehensive management concept issued by the European Foundation for Quality Management. In the case of a medical laboratory, the term "business excellence" should be replaced by "good medical laboratory services". The proposed model could serve as a basis for future developments of total quality management standards in laboratory medicine. The goal of the "journey" should be clarified before it starts. To the best of our knowledge, this is the first attempt to develop a model of a good medical laboratory.

Accreditation↗