Contrast of survey results between state and a cohort of nonstate mycobacteriology laboratories: changes in laboratory practices.

Based on the recommendations of a 1992 conference on tuberculosis, the Centers for Disease Control and Prevention (CDC) established programs for upgrading mycobacteriology laboratories by providing them with monies and focused training. In 1991, state public health laboratories were surveyed to determine the methods they were using for primary Mycobacterium tuberculosis testing and their turnaround times for reporting testing results. A similar survey of nonstate laboratories participating in the National Laboratory Training Network-sponsored, M. tuberculosis-focused training programs was conducted from May 1992 to June 1993. In 1994, follow-up surveys of both the state- and nonstate-laboratory cohorts were conducted with the questionnaire from the initial survey plus additional questions that asked about interventions and changes occurring in the laboratory since the original survey. Although both cohorts showed increases in the percentages of laboratories meeting the recommended turnaround times for reporting M. tuberculosis testing results and using the recommended rapid methods for testing, generally, the increases made by the state laboratories were greater. By June 1994, all state laboratories were using a rapid method for M. tuberculosis isolate identification compared with 88% of the nonstate laboratories. The percentage of laboratories identifying isolates within the recommended 21 days also increased more in the group of state laboratories than in the group of nonstate laboratories (state laboratories, 22 to 73%; nonstate laboratories, 55 to 59%). Responses from the follow-up survey showed large differences in the percentages of laboratories that received CDC funding (state laboratories, 100%; nonstate laboratories, 6%) and participated in M. tuberculosis training (state laboratories, 98%; nonstate laboratories, 45%). These results indicate that adequate funding and focused training are critical in maintaining state-of-the-art mycobacteriology laboratories.     

The World Health Organization's External Quality Assurance System Proficiency Testing Program has improved the accuracy of antimicrobial susceptibility testing and reporting among participating laboratories using NCCLS methods

A total of 150 laboratories in 33 countries that followed the NCCLS testing procedures participated in the World Health Organization's External Quality Assurance System for Antimicrobial Susceptibility Testing (EQAS-AST) from January 1998 through March 2001. Laboratories tested seven bacterial isolates for antimicrobial resistance and reported the results to the Centers for Disease Control and Prevention (CDC) in Atlanta, Ga. The results were compared to the results generated at the CDC with the NCCLS broth microdilution and disk diffusion reference methods. Although there were few testing errors with Salmonella enterica subsp. enterica serovar Enteritidis, drugs that are not appropriate for therapy of Salmonella infections were tested and reported by 136 (91%) of 150 laboratories. In addition, 29 (20%) of 150 laboratories used the Staphylococcus aureus breakpoints to report oxacillin results for Staphylococcus saprophyticus. For a vanB-containing Enterococcus faecalis strain, 124 (83%) of 150 laboratories correctly reported vancomycin results that were +/-1 doubling dilution from the reference MIC or +/-3 mm from the reference disk diffusion result. Of the laboratories that tested Streptococcus agalactiae by disk diffusion, 17% reported nonsusceptible results for penicillin in error. While 110 laboratories (73%) tested the S. pneumoniae challenge isolate against a fluoroquinolone, 83% tested it against ciprofloxacin, for which there are no NCCLS interpretive criteria. Ten of 12 laboratories testing levofloxacin and 4 of 4 laboratories testing ofloxacin by an MIC method correctly reported resistant results for the isolate. Feedback letters sent to participating laboratories highlighted areas of susceptibility testing in individual laboratories that needed improvement. The positive impact of the feedback letters and the overall effectiveness of the EQAS program were documented in repeat testing challenges with pneumococci and staphylococci. The 31 and 19% increases in the numbers of laboratories using appropriate testing methods for pneumococci and staphylococci, respectively, in 2000 versus 1998 indicate that laboratory performance is improving.     

Der Multiple Wachbleibetest (MWT)

Question of the study

The present results are based on a recent questionnaire survey on the implementation of Maintenance of Wakefulness Tests (MWTs) in Deutsche Gesellschaft für Schlafmedizin (DGSM)-accredited laboratories.

Methods

The questionnaire was sent to 308 DGSM-accredited sleep laboratories. Some questions had been previously used in the 2004 survey on the implementation of Multiple Sleep Latency Tests and MWTs. Analysis comprised all questionnaires which were returned by the end of April 2009. Results were compared to the findings of 2004.

Results

The response rate was 75.3% (232 laboratories). Of these laboratories, the MWT is regularly applied in 38.4% and irregularly in 2.6% of laboratories, while 59.1% of participating laboratories do not apply the MWT. The majority of these sleep laboratories (47.4%) stated that they perform the 40-min version of the MWT, 43.2% use a 20-min version, and 9.6% use different lengths. The MWT is most frequently applied in the diagnosis of hypersomnia (47.0%), narcolepsy (29.5%), and sleep-related breathing disorders (27.4%). Further indications are the assessment of occupational at-risk groups (e.g., professional drivers, in 45.3% of laboratories) and therapy evaluation. Scoring and interpretation of results vary between laboratories.

Conclusion

In contrast to the 2004 survey results, the MWT is used more frequently by DGSM-accredited laboratories, whereas scoring and interpretation of results are very inhomogeneous. Since the implementation, evaluation, and interpretation of the MWT is handled very heterogeneously by the sleep laboratories, the use of a uniform protocol, as recommended by the American Academy of Sleep Medicine, is desirable.     

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.     

Developing best practice for fungal specimen management: audit of UK microbiology laboratories

This study represents an audit of microbiology laboratories in the UK to ascertain whether they are aware of, or follow, the Health Protection Agency (HPA) National Standard Methods Standard Operating Procedure (NSM SOP) for the investigation of dermatological specimens for superficial mycoses, or use a locally adapted version. A questionnaire audit was distributed to 179 NHS microbiology laboratories throughout England, Wales, Scotland and Northern Ireland. The NSM SOP was followed by 92% of laboratories for the microscopy of dermatological samples; light microscopy/ KOH digestion was used by 63% and fluorescence microscopy/KOH digestion by 29% of laboratories. Preliminary reports post-microscopy were issued by 98% of laboratories, with 93% issuing reports within 48 hours. Adherence to the NSM SOP guidelines for culture was low; only 34% of laboratories incubated microscopy-negative specimens for the recommended 14 days, while approximately 60% incubated microscopy-positive specimens for 21 days. The culture medium recommended by the NSM SOP was used in 82% of laboratories. Comments were added to culture reports by 51% of laboratories; most were added manually and comments varied between laboratories. Nail samples were the most common sample received from primary care, followed by skin and hair. These results show no significant difference in the rate of microscopy positives versus culture positives. Microscopy and culture are the easiest and cheapest methods available to UK laboratories for the investigation of suspected superficial fungal infections. Although most laboratories included in this audit claimed to follow the NSM SOP for microscopy and culture, these results show that the techniques used vary throughout the UK. To maximise the service provided to primary care, UK laboratories should use standardise methods based on the NSM SOP.     

Indirect immunofluorescence test performance and questionnaire results from the Centers for Disease Control Model Performance Evaluation Program for human immunodeficiency virus type 1 testing.

Results from laboratories performing indirect immunofluorescence (IIF) testing for human immunodeficiency virus type 1 antibody and participating in the Centers for Disease Control Model Performance Evaluation Program in 1988 are presented. Approximately 90% of all laboratories receiving specimen panels or questionnaires furnished results to the Centers for Disease Control. In September 1988, 111 reports were received from IIF laboratories from 34 states and nine countries; most of these laboratories did IIF testing in conjunction with other antibody tests. Hospital laboratories were the most common type of laboratory participating in the program. Laboratories that performed IIF employed fewer personnel and performed testing less frequently than did laboratories that performed enzyme immunoassays or Western blot (immunoblot) tests and were likely to use a commercial test kit. Most of the laboratories that referred specimens for IIF testing sent them to the state laboratory. The analytic specificity for the Model Performance Evaluation Program specimens was 98.5% when indeterminate results on a negative specimen were considered correct (negative) and 89.6% when indeterminate results on a negative specimen were considered incorrect; analytic sensitivity was 94.8% when indeterminate results on a positive specimen were correct (positive) and 91.4% when indeterminate results on a positive specimen were considered incorrect. When indeterminate results were considered correct, all types of laboratories (blood bank, state, hospital, independent, and other) had analytic specificities over 96%, and all manufacturers had analytic specificities above 95%. All types of laboratories had analytic sensitivities over 92%, and analytic sensitivities were above 94% for all manufacturers and reagent sources except Cellular Products. Comparison of percentages of correct responses between IIF and Western blot assays on those samples for which there was good agreement on the target interpretation revealed no significant differences. Both individual donor and diluted materials were included in the evaluations; the diluted donor material presented the greatest testing difficulty. Within-survey reproducibility was about 93% overall and by specimen type. Between-survey reproducibility was about 81% for negative and indeterminate specimens and 88.5% for positive specimens, for an overall between-survey reproducibility of 84.3%. Differences in performance were noted when results were compared by type of laboratory and test manufacturer.     

Expertise of French laboratories in detection, genotyping, and quantification of hepatitis C virus RNA in serum

Before initiating new large-scale therapeutic trials for hepatitis C virus (HCV)-infected patients, the French Health Authorities for HCV research decided to organize an evaluation of the expertise of laboratories that could be engaged to undertake molecular biology assays in such trials; 21 experienced laboratories participated in this national evaluation of laboratory expertise, which was performed in two successive rounds. The first round evaluated the laboratories for their abilities to detect HCV RNA in serum, determine genotypes, and quantify HCV RNA loads. The results observed by qualitative assays for HCV RNA detection were 100% sensitivity and 100% specificity for all laboratories. The genotyping results were 100% concordant for 9 laboratories and greater than 90% for 10 laboratories. By contrast, large coefficients of variation were observed for quantitative determination of HCV RNA loads, leading to a second round with standardized quantitative assays only. The dispersion of the results was larger by the AMPLICOR HCV Monitor assay than by the branched-DNA assay (mean coefficients of variation, 57.4 and 16.9%, respectively). In the majority of cases, discrepancies between the results of the two tests were found for samples with high viral loads. These results indicate the usefulness of validating, by controlling for expertise, both the reliabilities of laboratories involved in multicenter work and the standardized assays chosen for use in the evaluation of the biological impacts of new therapies.     

Repeated HIV-1 resistance genotyping external quality assessments improve virology laboratory performance

The performance of French virology laboratories belonging to the ANRS network has been assessed annually for 3 years. The performance of these laboratories was compared between the years 2002 and 2003. Ten and 7 coded samples were sent to 38 virology laboratories in 2002 and 45 virology laboratories in 2003, respectively. Each panel of coded samples included at least one HIV-negative control, a pair of duplicate specimens, samples with a wide range of viral loads, and samples with a large number of resistance mutations. The laboratories used their standard sequencing procedures and were asked to report the amino acids at codons associated with resistance mutations, based on the IAS-USA expert panel list. The reference amino acid sequences were defined as those most frequently reported by the participants. The specificity of detection of RT mutations was significantly better in 2003 (99.9%) than in 2002 (99.7%) (P = 0.05). There was no difference between 2002 and 2003 in the specificity of detection of protease mutations (99.6% and 99.8%) or the sensitivity of detection of RT mutations (98.8% and 98.2%). The sensitivity of detection of protease mutations improved significantly between 2002 and 2003 (97.6% and 99.0%, respectively; P = 0.037). The proportion of laboratories reporting fully accurate results, in terms of amplification, specificity, sensitivity, and reproducibility, tended to increase between 2002 and 2003 (P = 0.077). No errors were made by 19% of laboratories in 2002, compared to 42% in 2003. These results show the value of repeated external quality assessments.     

Interlaboratory agreement study of a double set of PCR plasmid primers for detection of Chlamydia trachomatis in a variety of genitourinary specimens.

We conducted a tricenter interlaboratory agreement study to assess the agreement of PCR results obtained for detection of Chlamydia trachomatis in genitourinary specimens. A total of 120 specimens (49 positive and 71 negative), including 20 first-void urine samples, 50 endocervical and 50 urethral swabs (40 males), were coded and sent from a reference laboratory (laboratory A) to two other laboratories. Laboratories B and C were provided with a standardized protocol and reagent package including two sets of plasmid PCR primers (KL1-KL2 and T1-T2) and were asked to test each specimen with the first set of primers (KL1-KL2) and to confirm positives with the second set of primers (T1-T2). Laboratory B identified 47 of 49 positives and 69 of 70 negatives (one specimen dried up on shipping) following the initial PCR, for an accuracy of 97.5% (116 of 119), and 47 of 49 positives and 70 of 70 negatives after confirmatory testing of the positives, for an accuracy of 98.3% (117 of 119). Laboratory C identified 42 of 49 positives and 70 of 70 negatives for the initial PCR, for an accuracy of 94.1% (112 of 119), and 39 of 42 positives and 70 of 70 negatives for the confirmatory PCR, for an accuracy of 91.6% (109 of 119). The overall accuracy of PCR testing was 96.6% (345 of 357). The kappa agreement statistics for agreement between pairs of laboratories after confirmation of positives were 0.97 for laboratories A and B, 0.83 for laboratories B and C, and 0.83 for laboratories A and C. Use of the confirmatory PCR improved the specificity and overall accuracy of results for individual laboratories but reduced slightly the results obtained for agreement between laboratories. These results demonstrate that when standardized reagents and protocols are used, PCR results are highly reproducible and excellent agreement between laboratories is obtainable.     

Practice patterns of testing waived under the clinical laboratory improvement amendments

OBJECTIVES: To determine operational practices in laboratories operating under a Certificate of Wavier (waived laboratories), or equivalent, under the Clinical Laboratory Improvements Amendments (CLIA) of 1988 when performing tests designated as having an insignificant risk of an erroneous result (ie, waived tests). METHODS: Waived laboratories that were part of the Centers for Disease Control and Prevention Laboratory Sentinel Monitoring Network project in the states of Arkansas, New York, and Washington were surveyed about their quality control (QC) and quality assurances (QA) practices when performing waived testing. Arkansas and Washington sent out similar questionnaires, whereas on-site surveys were conducted in New York. The survey in Arkansas and Washington also included nonwaived laboratories. The New York visits were designed to pilot test a regulatory inspection program for limited testing sites, which, in New York, are roughly equivalent to laboratories operating under a CLIA Certificate of Wavier and/or Provider-Performed Microscopy but are generally not located in physicians' offices. Laboratories visited in New York were selected from a list of limited testing sites and were representative of that population. RESULTS: Arkansas received responses from 211 facilities (37% response rate), of which 38% had Certificates of Waiver. Washington received responses from 190 waived laboratories (71% response rate) and from 116 nonwaived laboratories (32% response rate). In New York, 607 of the 2751 limited testing laboratories were visited. Reporting laboratories in all 3 states most frequently performed testing for glucose, urinalysis, urine human chorionic gonadotropin, occult blood, and group A Streptococcus antigen, although other waived tests were performed less frequently. Washington found that 57% of waived laboratories followed manufacturers' QC requirements. Arkansas found that 58% of laboratories doing waived tests that required liquid controls performed these controls, and 59% performing waived testing requiring electronic controls used these controls. In New York, 68% of the laboratories complied with the manufacturer's QC requirements for a variety of tests. Being accredited by an external organization or affiliated with a more complex laboratory improved compliance. Nonwaived laboratories in Washington and Arkansas complied with manufacturer's instructions at a higher rate than did waived laboratories. Similar deficiencies in following CLIA requirements were found in other areas of laboratory operation. CONCLUSIONS: Just more than half of waived laboratories in 3 diverse states follow manufacturer's instructions for recommended QC and QA. These instructions help ensure that the test will produce results that have an insignificant chance of an error. Although we did not study the impact of this and other findings on patient care, the results show that imposing good laboratory practices by regulation alone was insufficient to ensure quality laboratory results in any location evaluated. A system that can continually provide accessible education on laboratory practices, coupled with new thoughts on the regulatory environment, is in order.     

National External Quality Assessment for medical biology laboratories in Burkina Faso: an overview of three years of activity

We report results of the National External Quality Assessment for (NEQA) laboratories in Burkina Faso, a country with limited resources located in West Africa whose epidemiology is dominated by infectious diseases. The national laboratory network consists of 160?laboratories including 40?private. The Government of Burkina Faso has adopted a national laboratory policy. One of the objectives of this policy is to improve the quality of laboratory results. One of the strategies to achieve this objective is the establishment of a NEQA. The NEQA is a panel testing also called proficiency testing. It is mandatory for all laboratories to participate to the NEQA. The NEQA is organized twice a year and covers all areas of laboratories (bacteriology-virology, biochemistry, hematology, parasitology and immunology). The review of three years of activity (2006-2008) shows the following results: (1) for microscopic examination of bacteria after Gram staining, the error rate decreased from 24.7% in 2006 to 13.1% in 2007 and 13% in 2008; (2) errors rate in reading slides for the microscopic diagnosis of malaria were 23.4%, 14.6% and 10.2% respectively in 2006, 2007 and 2008; (3) for biochemistry, the percentages of unsatisfactory results were respectively 12.5%, 14.8% and 13.8% in 2006, 2007 and 2008 for the overall parameters assessed. The analysis of the results generated by the laboratories during these three years shows a quality improvement. However, the NEQA should be strengthened through ongoing training and quality control of reagents and equipment.     

Impact of proficiency testing on results of the microscopic agglutination test for diagnosis of leptospirosis

A proficiency testing scheme for the leptospirosis microscopic agglutination test was provided to 37 laboratories in 23 countries in 2002 (round 1) and to 60 laboratories in 34 countries in 2003 (round 2). Thirty-four laboratories participated in both rounds. Each panel consisted of five rabbit serum samples, four of which were antisera raised against pathogenic serovars of Leptospira. One of these samples was a mixture of two different antisera. The rates of false-negative results, calculated on the basis of the assumption that serovars within a serogroup will cross-react, were 11% for round 1 and 14% for round 2. There were regional differences in the rates of false-negative results. The titers reported by laboratories testing for the same sample with the same serovar varied widely. Laboratories that had previously participated in round 1 reported fewer false-negative results in round 2 than new participants (10 and 21%, respectively [P = 0.002]) and reported 0.56 false-negative results per participant, whereas new participants reported 1.23 false-negative results per participant (P = 0.041). Laboratories that had previously participated also reported fewer false-negative results in round 2 than in round 1 when samples common to both rounds were tested (5 and 15%, respectively [P = 0.028]). The titers reported by the new participants were, on average, lower than those reported by the laboratories that had participated previously (P = 0.019) and were significantly more variable (P = 0.001). Analysis of these results suggests a positive impact of proficiency testing on the testing performance of the participating laboratories.     

Laboratory methods for detection of Chlamydia trachomatis: survey of laboratories in Washington State.

The last decade has witnessed the development of a wide variety of diagnostic tests for Chlamydia trachomatis. In order to determine what laboratory methods are being used to detect C. trachomatis infections in Washington State and to identify factors influencing test selection, between April 1995 and October 1995 we conducted a mailed questionnaire survey of all 112 laboratories certified to do chlamydia testing. Of these, 20 had discontinued testing for C. trachomatis, and responses were obtained from 89 (97%) of the remaining 92 laboratories. Surprisingly, 38 (43%) of the 89 laboratories used rapid tests such as Clearview and Surecell, making such tests the most commonly used laboratory tests. Laboratories which used rapid tests had lower test volumes, less experience performing tests for C. trachomatis, less frequent attendance at professional meetings, and greater reliance on manufacturers for information compared with laboratories which used other methods. Confirmation of non-culture-positive results was provided by 28 (34%) of the 82 laboratories doing non-culture-based tests. Forty-one (47%) of 88 laboratories reported having compared their method with another method. Test volume was the strongest predictor of laboratories which confirmed positive non-culture-based test results and which had performed a laboratory comparison of methods. We conclude that rapid tests for C. trachomatis are often being used inappropriately and that efforts are needed to improve effective implementation and quality assurance of laboratory testing for C. trachomatis.     

Current practices in mycobacteriology: results of a survey of state public health laboratories.

Fifty-six state and territorial public health laboratories were surveyed to determine whether currently available rapid methods for the identification and drug susceptibility testing of Mycobacterium tuberculosis were being performed. Forty (71%) laboratories use fluorochrome rather than conventional basic fuchsin stains for screening clinical specimens for acid-fast bacilli. Of the 55 laboratories that routinely culture for mycobacteria, 16 (29%) use the more rapid radiometric methods. Species identification of isolates is done by biochemical tests in 13 (23%) laboratories; 40 (72%) use nucleic acid probes, high-performance liquid chromatography, or the BACTEC p-nitro-alpha-acetylamino-beta-hydroxypropiophenone (NAP) test (rapid tests); 3 laboratories do not perform species identification. Drug susceptibility testing is performed with solid media by 36 of 45 (80%) laboratories, while the more rapid radiometric methods are used by 9 (20%) laboratories. Compared with the laboratories that use conventional methods, laboratories that use rapid methods report results more quickly: for species identification, 43 days (conventional) versus 22 days (rapid); for drug susceptibility testing, 44 days (conventional) versus 31 days (rapid) from specimen processing. Rapid technologies for microscopy and species identification are being used by many, but not all, state and territorial public health laboratories; however, most laboratories do not use the more rapid radiometric methods for routine culture or drug susceptibility testing of mycobacteria. Implementation of such rapid technologies can shorten turnaround times for the laboratory diagnosis of tuberculosis and recognition of drug resistance.     

Atypical epithelial cells and specimen adequacy: current laboratory practices of participants in the college of American pathologists interlaboratory comparison program in cervicovaginal cytology

CONTEXT: The Bethesda System for reporting cervical/vaginal cytologic diagnoses introduced terminology for atypical squamous and glandular cells and categories for specimen adequacy. OBJECTIVES: To analyze current laboratory reporting practices and compare trends to previous surveys. DESIGN: Questionnaire surveys were mailed to 2000 laboratories in 1996 and 1997. PARTICIPANTS: Laboratories enrolled in the College of American Pathologists Interlaboratory Comparison Program in Cervicovaginal Cytology. MAIN OUTCOME MEASURES: Laboratory policies, criteria, and reporting rates for Bethesda System categories. RESULTS: The 1996 specimen adequacy survey had 1166 respondents, and 768 laboratories returned the 1997 questionnaire focusing on atypical squamous cells of undetermined significance (ASCUS) and glandular cells of undetermined significance (AGUS). Nearly all laboratories (92%) routinely reported specimen adequacy, an increase from the 66% rate in 1991. The median rate for unsatisfactory specimens was 0.5% (mean 0.95%), and the median rate for the satisfactory but limited category was 5.8% (mean 9.3%). The Bethesda criteria for designating a specimen unsatisfactory were used by more than 90% of laboratories. Nearly all laboratories (97%) used the term ASCUS in 1997, and more than 80% of laboratories used the Bethesda criteria for this category. Median reporting rates for epithelial abnormalities were as follows: ASCUS, 4.5%; AGUS, 0.3%; low-grade squamous intraepithelial lesion (SIL), 1.6%; and high-grade SIL, 0.5%. The median ASCUS/SIL ratio was 2.0, with 80% of laboratories reporting ratios between 0.64 and 4.23. The median ASCUS rate and ASCUS/SIL ratio were higher than 1993 survey results. Nearly all laboratories attempted follow-up studies on patients with abnormal cytology results, and midsized laboratories achieved the highest rates of follow-up. Median rates of abnormalities following an ASCUS or AGUS diagnosis were 20% and 15%, respectively. Laboratory respondents commonly used written recommendations in ASCUS/AGUS reports. CONCLUSIONS: Most laboratories that responded to the surveys had adopted Bethesda terminology and criteria for specimen adequacy and ASCUS/AGUS. Reporting rates for SIL and adequacy categories have remained stable, but median ASCUS rates and ASCUS/SIL ratios are higher than in 1993. The AGUS category is reported infrequently, but can be associated with significant pathology.     

2008年揭阳市艾滋病筛查实验室质量评价

目的通过室间质量考评,规范揭阳市艾滋病检测筛查实验室的建设和管理,确保检测质量。方法分析2008年揭阳市医疗卫生机构的13个艾滋病检测筛查实验室的质量考评情况。结果考评综合成绩,13个艾滋病检测筛查实验室全部合格,取得良好以上成绩的实验室占69．23％。医疗、妇幼机构考评成绩较差,主要问题在于弱阳性样品的检测出现错检、漏检情况。总体分析,本次考评出现问题的主要环节是室内质控、定量仪器的校准及检定、生物安全防护。结论全市艾滋病检测筛查实验室总体上检测质量较好,基本符合艾滋病筛查实验室的要求,弱阳性样品检测能力、质量控制和生物安全是薄弱环节。     

Impact of Proficiency Testing Program for Laboratories Conducting Early Diagnosis of HIV-1 Infection in Infants in Low- to Middle-Income Countries

A voluntary, cost-free external quality assessment (EQA) program established by the U.S. Centers for Disease Control and Prevention (CDC) was implemented to primarily monitor the performance of laboratories conducting HIV Early Infant Diagnosis (EID) from dried blood spots (DBS) in low- to middle-income countries since 2006. Ten blind DBS proficiency test (PT) specimens and 100 known HIV-positive and -negative DBS specimens (to be used as internal controls) were shipped triannually to participating laboratories with reports for the PT specimens due within 30 days. The participant''s results and a summary of the performance of all participating laboratories and each diagnostic method were provided after each test cycle. Enrollment in the CDC PT program expanded progressively from 17 laboratories from 11 countries in 2006 to include 136 laboratories from 41 countries at the end of 2012. Despite external pressures to test and treat more children while expanding EID programs, mean PT test scores significantly improved over time as demonstrated by the upward trend from mid-2006 to the end of 2012 (P = 0.001) and the increase in the percentage of laboratories scoring 100% (P = 0.003). The mean test scores plateaued over the past 10 testing cycles, ranging between 98.2% and 99.7%, and discordant test results still occur but at a rate of no higher than 2.6%. Analysis of these test results suggests a positive impact of proficiency testing on the testing performance of the participating laboratories, and a continuous training program and proficiency testing participation may translate into laboratories improving their testing accuracy.     

GEMHEP multicenter quality control study of PCR detection of GB virus C/hepatitis G virus RNA in serum.

PCR is, to date, the only available tool for the detection of GB virus C (GBV-C) and hepatitis G virus (HGV) RNAs. Twenty-two French laboratories participated in a quality control study to assess the sensitivity and specificity of their procedures. The panel included 13 positive controls and 7 negative controls. The laboratories used either in-house PCR techniques adapted from the literature or partly standardized commercial tests. Three laboratories performed faultlessly with the entire panel. Most laboratories had excellent specificity (100% in 20 of 22 laboratories). Sensitivity was acceptable (85 to 100%) in 15 centers and insufficient (38 to 77%) in 7. As with nonstandardized in-house PCR, the commercial assays gave discrepant performances in different laboratories. These results suggest that laboratories willing to use PCR for detection of GBV-C/HGV RNA for research or diagnostic purposes should participate in multicenter quality control trials.     

Role of clinical laboratory in Japanese general hospital for equilibrium functional tests

Recent automation in clinical laboratories affords healthcare providers with numerous options in terms of physiological tests. However, the role of the clinical laboratory in the field of equilibrium functional tests is not clearly defined. Therefore, we conducted a questionnaire survey to define the role of clinical laboratories in general hospitals. We present the results of our investigation and the approach employed by the clinical laboratory of our hospital. Rates of healthcare providers desiring the conduct of equilibrium functional tests by clinical laboratories were 78% and 70% in otolaryngology and neurosurgery departments, respectively; moreover, 92% of technologists from clinical laboratories responded that an equilibrium functional test can be performed upon request. Furthermore, 84% of clinical laboratory staff members and 77% of staff from neurosurgery departments agreed that implementation of a system allowing each department to request equilibrium functional tests from the clinical laboratories is necessary. This finding was indicative of the high demand for equilibrium functional tests by clinical laboratories. Therefore, equilibrium functional tests offered by clinical laboratories not only reduce the workload of the otolaryngology department, but also result in a major contribution with respect to management of the entire hospital in terms of high quality examination findings and allocation of healthcare providers in other departments.