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PubMed1996

U.S. hospital mycobacteriology laboratories: status and comparison with state public health department laboratories.

In response to the resurgence of tuberculosis, the Centers for Disease Control and Prevention recommended the use of certain mycobacteriology laboratory methods to improve the accuracy of diagnosis and/or minimize times to complete specimen processing. A study to determine the extent to which these recommended methods were being used in hospital laboratories was needed. In 1992, a survey was mailed to infection control and laboratory personnel at 1,076 hospitals with > or = 100 beds to determine the mycobacterial laboratory services being performed, the methods being used, the number of specimens being processed, and the times to completion during 1991. In 1995, a 20% sample of hospital laboratories that responded to the initial questionnaire was resurveyed. Responses to the 1992 survey were received from personnel at 756 (70%) hospitals representing 750 laboratories. Among laboratories performing the services, the use of recommended methods was as follows: fluorochrome stain for acid-fast bacillus microscopy (47%); radiometric methods for primary culture (29%); rapid (radiometric methods, use of nucleic acid probes, high-performance liquid chromatography, or gas-liquid chromatography) methods for identification of Mycobacterium tuberculosis (59%); and radiometric methods for drug susceptibility testing (55%). Reported times to complete specimen processing were shortest for laboratories that used recommended methods and longest for hospitals that referred specimens to outside laboratories. Only 46% of surveyed laboratories performed at least the minimal number of mycobacterial cultures (20/week) deemed necessary to maintain competence. Among 145 laboratories that performed the services and were resurveyed in 1995, use of recommended techniques increased from 44 to 73% for acid-fast bacillus microscopy, from 27 to 37% for primary culture, from 59 to 88% for M. tuberculosis identification, and from 55 to 75% for drug susceptibility testing. These changes were associated with reductions in reported specimen turnaround times. Use of the methods recommended by the Centers for Disease Control and Prevention increased at the resurveyed hospital mycobacteriology laboratories between 1991 and 1995. However, continued efforts are needed to increase the use of recommended methods at moderate- and high-volume laboratories, encourage referral of specimens from low-volume laboratories, and transmit results rapidly from all laboratories.

Humans↗
PubMed1997

Descriptive profile of tuberculin skin testing programs and laboratory-acquired tuberculosis infections in public health laboratories.

The increase in numbers of cases of tuberculosis in the United States has placed greater demands on mycobacteriology laboratory workers to produce rapid and accurate results. The greater number of specimens generated by the increased emphasis on detecting the disease has placed these workers at greater risk of laboratory-acquired infection. We surveyed 56 state and territorial public health laboratories to determine the status of existing tuberculin skin testing (TST) programs and to evaluate the frequency of probable laboratory-acquired tuberculosis for each responding mycobacteriology laboratory. Probable laboratory-acquired infections were determined by each laboratory's evaluation of occupational positions, duties, and employee histories and review of medical records. Two-step TST for new employees was routinely practiced in only 33% of responding laboratories, and mycobacteriology laboratorians were found to be most frequently screened when they were compared to employees of other departments. Of 49 (88%) responding laboratories, 13 reported that 21 employees were TST converters from 1990 to 1994. Seven of these 21 employees were documented to have laboratory-acquired infections based on evaluations by their respective laboratories. Based on Centers for Disease Control and Prevention guidelines, converters are categorized on the basis of both a change in the size of the zone of induration and the age of the person being tested. By the definitions in the guidelines, 14 mycobacteriologists were identified as recent converters, 7 of whom were > or = 35 years of age and 4 of whom were exposed in the laboratory within a 2-year period. Inadequate isolation procedures, the high volume of specimen handling, and faulty ventilation accounted for these laboratory-associated infections. These results suggest that more frequent periodic evaluations based on documented TST conversions for workers in mycobacterial laboratories should be performed, since this population is at increased risk of becoming infected with Mycobacterium tuberculosis. Although general assessments are necessary to accurately and effectively evaluate the risk of tuberculosis transmission, they are especially important for those working in high-risk areas within a public health laboratory.

Humans↗
PubMedDate not supplied

Laboratory to laboratory variation in Chlamydia trachomatis culture practices.

GOAL OF THIS STUDY: To compare laboratory to laboratory variability in methods of cell culture for Chlamydia trachomatis performed by North American research laboratories. STUDY DESIGN: The authors administered a standardized 54-question survey to laboratories that had published articles in any of three medical journals reporting on the use of cell culture to identify individuals with C. trachomatis infection. Laboratory to laboratory variability in specimen collection, specimen transport conditions, culture methodologies, and criteria for evaluation of culture outcomes was examined. RESULTS: Twenty-five (93%) of 27 laboratories responded to the survey. Only two of 54 questions were answered uniformly by all responding laboratories. All laboratories reported vortexing or sonication of specimens before culture inoculation and centrifugation of inoculated cultures prior to incubation. In contrast, substantial variation was noted in specimen collection devices, specimen transport conditions and times, culture format, culture procedures, and criteria for identifying positive cultures. CONCLUSION: Although this study did not evaluate the sensitivity of chlamydia cell cultures performed in different laboratories, there was substantial laboratory to laboratory variation in nearly every facet of culture evaluated. Laboratory to laboratory variation in chlamydia cell culture sensitivity likely accounts for part of the substantial variability in published evaluations of the sensitivity of nonculture chlamydia diagnostic tests.

Bacteriological Techniques↗
PubMed1999

Laboratory testing for von Willebrand's disease: an assessment of current diagnostic practice and efficacy by means of a multi-laboratory survey. RCPA Quality Assurance Program (QAP) in Haematology Haemostasis Scientific Advisory Panel.

We report an evaluation of current laboratory practice for the diagnosis of von Willebrand's disease (VWD) by means of a multilaboratory survey. This assessment was undertaken with the RCPA Quality Assurance Program (QAP) in Haematology, which covers a wide geographic area encompassing Australia, New Zealand and Asia. A total of 25 laboratories actively involved in testing for VWD were selected to participate in a sample testing assessment exercise. Samples comprised 10 plasmas: (i) a normal plasma pool (in duplicate), (ii) this pool diluted to 50% (in duplicate), (iii) a normal individual (X1), (iv) severe Type 1 VWD (X1), (v) Type 2B VWD (x2 unrelated donors), (vi) Type 3 VWD (x1), (vii) Type 2A VWD (x1). Laboratories were asked to perform all tests available to them in order to establish a laboratory diagnosis of VWD, and then to comment on the possibility or otherwise of VWD. Overall findings indicated a wide variation in test practice, in the effectiveness of various test procedures in detecting VWD, and in the ability of various composite test panels to identify type 2 VWD subtypes. Firstly, while all laboratories (n = 25) performed tests for FVIII:C activity, von Willebrand factor 'antigen' (VWF:Ag) and a functional VWF assay [using the ristocetin cofactor assay (VWF:RCo; n = 23) and/or the collagen binding assay (VWF:CBA; n = 12)], only three laboratories carried out VWF:Multimer analysis. Secondly, for the three quantitative VWF assays, 10/25 (40%) laboratories performed all three, whereas 15/25 (60%) performed only two [VWF:Ag and VWF:RCo (n = 13); VWF:Ag and VWF:CBA (n = 2)]. Thirdly, a variety of assay methodologies were evident for VWF:Ag [ELISA, electro-immuno diffusion (EID), latex immuno-assay (LIA), and VIDAS assay] and VWF:RCo (platelet agglutination/'aggregometry' and a 'functional VWF:RCo-alternative' ELISA assay). Between method analysis for the quantitative VWF assays showed that the VWF:RCo yielded the greatest degree of inter-laboratory assay variation, and had the poorest overall performance with respect to sensitivity to low levels of VWF. The VWF:CBA also performed better than the VWF:RCo in terms of ability to detect functional VWF 'discordance' (i.e. Type 2 VWD). Within VWF:Ag method analysis showed that the EID assay procedure was associated with the greatest variation in assay results, while the EID and LIA test methods showed poorer sensitivity at low VWF levels compared to the ELISA method. Within the VWF:RCo assay procedure, greatest variation in assay results and poorest sensitivity to low VWF levels was obtained using the agglutination method; however, the agglutination procedure showed better performance than the 'functional VWF:RCo-alternative' ELISA assay in identifying Type 2 VWD plasma samples. Finally, despite identified variations, most laboratories appeared to understand the complexities involved in the VWD-diagnostic process, and made appropriate diagnostic predictions regarding tested samples. From a total possible 246 interpretation events, laboratories in most cases correctly identified normal samples as normal (67/75 events = 89%), and VWD samples as derived from individuals with VWD (117/121 events = 97%). Moreover, when VWD was suggested by laboratory findings, laboratories usually correctly predicted the general subtype of VWD present (96/109 events = 88%). When 'misinterpretations' occurred, these could often be linked to the test panels utilised by laboratories. That is, laboratories using the VWF:Ag and VWF:RCo combination were more likely to incorrectly identify samples derived from Type 2 VWD patients as being Type 1, Type 1 VWD patients as being Type 2, and normal plasma samples as potentially derived from patients with VWD, compared to those using the VWF:Ag and VWF:CBA.

Clinical Laboratory Techniques↗
PubMed1995

[Cost performance and TQC in laboratory management from the aspect of a commercial laboratory].

Whereas per capita national income in 1992 remained in 0.3% increase, national fee for medical treatment showed a remarkable increase of 7.6% compared with that of the previous year. A recent technological innovation in laboratory medicine such as nonisotopic immunoassays, biosensors and DNA techniques is another factor to rise up the medical expense. Hospital administrator and laboratory manager must consider the most effective laboratory management according to complexity grading of tests. Nowadays, large numbers of test items are ordered from hospitals or clinics to reference laboratories because of cost-analysis for environmental security, heavy instrumentation, problem for bio-hazards and employee fee, etc. Since 1992, when commercial laboratories were allowed legally to be stationed in hospitals as called "branch laboratories", hospital administrators have been in consideration to introduce this system. Commercial laboratories, on the other hand, have come to be obliged to build a laboratory network from branch laboratory through regional laboratory to main reference laboratory with a strict responsibility of TQA including collecting specimens, transportation, receipt, testing and reporting results with on-line computer system. The most important task in the laboratory site is protection of privacy of patient informations, since recent systematization of laboratory tests has led any person working in medical record office and laboratories to easy access to work stations.

Confidentiality↗
PubMed1998

Are physicians' office laboratory results of comparable quality to those produced in other laboratory settings?

CONTEXT: In 1995, California adopted a bill that brought laboratory laws in line with the 1988 Clinical Laboratory Improvement Amendments' standards for clinical laboratories and mandated a study comparing results in physicians' office laboratories (POLs) with other settings. OBJECTIVE: To determine whether persons conducting tests in POLs produce accurate and reliable test results comparable to those produced by non-POLs. DESIGN: Survey of clinical laboratories using proficiency testing data. SETTING: All California clinical laboratories participating in the American Association of Bioanalysts proficiency testing program in 1996 (n=1110). MAIN OUTCOME MEASURES: "Unsatisfactory" (single testing event failure) and "unsuccessful" (repeated testing event failure) on proficiency testing samples. RESULTS: The unsatisfactory failure rate for POLs was nearly 3 times (21.5% vs 8.1%) the rate for the non-POLs and about 1.5 times (21.5% vs 14.0%) for POLs that used laboratory professionals as testing or supervisory personnel (P<.001). The POL unsuccessful rate was more than 4 times (4.4% vs 0.9%) the rate for non-POLs and more than twice (4.4% vs 1.8%) the rate for the POLs using laboratory professionals (P<.001). CONCLUSIONS: Significant differences exist among POLs, POLs using licensed clinical laboratory scientists (medical technologists), and non-POLs. Testing personnel in many POLs might lack the necessary education, training, and oversight common to larger facilities. We must better understand the contributing factors that result in the poorer results of POLs relative to non-POLs. In the meantime, patients should be aware that preliminary findings suggest that differences in quality of laboratory tests based on testing site may exist. Laboratory directors at all testing sites must ensure that they understand laboratory practice sufficiently to minimize errors and maximize accuracy and reliability. Directors must understand their obligation when they elect to oversee those assigned testing responsibility. Legislators may wish to reconsider the wisdom of further easing restrictions on those to whom we entrust our laboratory specimens.

California↗
PubMed2002

The management of clinical laboratories in Europe: a FESCC survey. Forum of the European Societies of Clinical Chemistry and Laboratory Medicine.

The professional duties of the specialists in clinical chemistry differ from country to country in Europe. One of the main goals of the Strategic Plan of the Forum of the European Societies of Clinical Chemistry and Laboratory Medicine (FESCC; IFCC-Europe) is to promote a high scientific and professional standard in the field of clinical chemistry and laboratory medicine in Europe. This can be stimulated by the knowledge of the local conditions in each country and by striving towards a strong and harmonised position in all the European countries. In order to enhance the knowledge of the managerial situation of the specialists in clinical chemistry in Europe, FESCC launched a survey in September 2000. This survey provides information about the position of the specialists in clinical chemistry in the various disciplines in the medical laboratories and in hospitals, and about the advisory tasks and the managerial education during the post-graduate training in clinical chemistry. Of the 35 FESCC member countries 33 have participated in the survey (94%). The results show a rather heterogeneous situation in Europe caused by the local historical developments, the differences in academic background and the relative numbers of private and physicians' office laboratories. Large differences exist between the European countries in the disciplines of laboratory medicine that are headed by a specialist in clinical chemistry. In the different countries the clinical chemistry laboratories are headed by specialists in clinical chemistry in between 20% and 100% of the laboratories. The haematology, immunology, microbiology, therapeutic drug monitoring, molecular biology and haemostasis laboratories and departments of blood banking are headed by specialists in clinical chemistry in between 0% and 100% of the laboratories. The responsibilities for the various managerial tasks of the specialists in clinical chemistry show no uniformity in Europe. In the majority of the countries the general management, the purchase of equipment and reagents and the education of technicians are in >90% the responsibility of the specialists in clinical chemistry. In most countries the majority of the specialists in clinical chemistry are members of the medical staff of the hospitals and have a position equivalent to the position of specialists in other medical disciplines. In some countries, however, it only holds true for the specialists with a medical background. In 79% of the countries the law regulates the profession of the specialists in clinical chemistry and in 60% of the countries the law regulates their position in the medical staff of the hospital. The advisory tasks to physicians, general practitioners and other users of laboratory tests are practised by >90% of the laboratories in 64% of the countries. Information is given directly to the patients by >90% of the laboratories in 30% of the countries. Only in a few countries laboratories give information to the public. The post-graduate training in clinical chemistry includes a managerial training in 58% of the countries, the study of information technology in 61% of the countries and an economy and/or a business administration study in 15% of the countries. In 27% of the countries no managerial education forms part of the post-graduate study in clinical chemistry. Harmonisation of the managerial aspects of the profession is one of the challenges for the European specialists in clinical chemistry. A European syllabus for post-graduate training could be helpful.

Chemistry, Clinical↗
PubMed2001

Six-year trends in productivity and utilization of 73 clinical laboratories: a College of American Pathologists Laboratory Management Index Program study.

OBJECTIVES: To describe longitudinal trends in the efficiency, labor productivity, and utilization of clinical laboratories in the United States. METHODS: Financial and activity data were prospectively collected from 73 clinical laboratories continuously enrolled in the College of American Pathologists Laboratory Management Index Program from 1994 through 1999. Each laboratory reported quarterly on its costs, labor inputs, and test activity using uniform data definitions. RESULTS: During the 6-year study period, there was a significant increase in laboratory labor productivity (2.1% more tests/full-time equivalent/y; P <.001). Productivity increases were offset by increasing labor expense (1.5%/full-time equivalent/y; P <.001), consumable expense (1.7%/on-site test/y; P =.005), and blood expense, which comprised more than 10% of laboratory expenses by 1999 (4.4% increase/y; P <.001). As a result, overall expense per test showed no significant change in non-inflation-adjusted dollars. Reference laboratory expense per test did not change significantly during the study period; the proportion of tests sent to reference laboratories grew slightly (0.06% increase/y; P <.001). Test volume of the median laboratory grew by 5442 tests per year (2.3% annual increase; P <.001), while the proportion of testing from inpatients declined by 1.7% per year (P <.001). Inpatient test utilization declined on a discharge basis (annual decline of 1.2 tests/inpatient discharge; P <.001) and on a per diem basis (annual decline of 0.08 tests/inpatient day; P =.002). Inpatient laboratory expense declined on a discharge basis (annual decline of $2.40 or 1.3% per discharge; P <.001), but did not change significantly per inpatient day. Most of the reduction in the expense per discharge occurred during 1994-1996. CONCLUSIONS: Between 1994 and 1999, clinical laboratories in the United States experienced significant changes in the cost of operations, utilization, and labor productivity. Laboratory administrators who compare local institutional performance with that of peers are advised to use current or forward-trended peer data. Quarter-to-quarter improvement in many measures of laboratory financial activity may not signal a superior operation, as performance of the whole industry appears to be improving.

Blood↗
PubMed2000

The role of total laboratory automation in a consolidated laboratory network.

BACKGROUND: In an effort to reduce overall laboratory costs and improve overall laboratory efficiencies at all of its network hospitals, the North Shore-Long Island Health System recently established a Consolidated Laboratory Network with a Core Laboratory at its center. METHODS: We established and implemented a centralized Core Laboratory designed around the Roche/Hitachi CLAS Total Laboratory Automation system to perform the general and esoteric laboratory testing throughout the system in a timely and cost-effective fashion. All remaining STAT testing will be performed within the Rapid Response Laboratories (RRLs) at each of the system's hospitals. RESULTS: Results for this laboratory consolidation and implementation effort demonstrated a decrease in labor costs and improved turnaround time (TAT) at the core laboratory. Anticipated system savings are approximately $2.7 million. TATs averaged 1.3 h within the Core Laboratory and less than 30 min in the RRLs. CONCLUSIONS: When properly implemented, automation systems can reduce overall laboratory expenses, enhance patient services, and address the overall concerns facing the laboratory today: job satisfaction, decreased length of stay, and safety. The financial savings realized are primarily a result of labor reductions.

Automation↗
PubMed1990

Clinical laboratory regulation under the Clinical Laboratory Improvement Amendments of 1988: can it be done?

This report examines logical but not yet widely recognized ramifications of the Clinical Laboratory Improvement Amendments of 1988 (CLIA'88), federal legislation that will require certification of all laboratories examining human specimens. Examination of the CLIA'88 committee reports and committee hearings suggest that more than the conventional approach to laboratory standards will be needed to meet the public's expectations as articulated by our elected representatives. The conventional approach to clinical testing standards seeks to assure quality by regulating the laboratory analytical process. However, little empirical evidence is available to support or refute this model, which has been used during the past 25 years. One alternative paradigm for laboratory standards is an approach that examines the total laboratory testing process, including the selection, ordering, and interpretation of the test as well as the laboratory analysis per se. The history of controversy over laboratory standards--especially personnel standards, the glacial federal regulatory rulemaking process, public expectations of fail-safe technology, among other factors--suggests the implementation of CLIA'88 will be a lengthy and vigorously debated contest. The risk of a test is seldom inherent in the test itself, but rather is a function of the context in which the test is being used to provide information for medical decision making. Our premise is that diagnostic tests must be examined in the context of the laboratory testing situation. We suggest that now is the appropriate time for laboratory professionals, practicing physicians, and the public to abandon conventional thinking regarding clinical laboratory standards. We believe that CLIA'88 reflects a shift in public expectations toward fail-safe laboratory testing and the need for additional government oversight in laboratory test quality. If these new expectations persist, CLIA'88 represents a potential landmark in the course of federal authority and the practice of medicine in the United States.

Humans↗
PubMed1987

The impact of the quality of laboratory staff on the accuracy of laboratory results.

This study tests the premise that laboratories employing medical technologists certified by the Board of Registry of the American Society of Clinical Pathologists (MT[ASCP]) produce more accurate laboratory test results, as measured by the College of American Pathologists proficiency tests. Licensed laboratories in Illinois provided the sample. An accuracy score on the College of American Pathologists proficiency tests was calculated for each laboratory. The accuracy score of a subgroup of laboratories employing all (100%) certified medical technologists was compared with the accuracy score of a subgroup of laboratories employing only noncertified medical technologists. Those laboratories employing only certified medical technologists had a mean accuracy score of 95% (SD = 4%), while laboratories employing only noncertified medical technologists had a mean accuracy score of 75% (SD = 30%). The Mann-Whitney U test was used to identify differences between the two groups of laboratories. A difference in the accuracy scores between the two groups of laboratories was statistically discernible. Since most laboratories employ some certified medical technologists, a second analysis considered the relationship of the proportion of certified medical technologists employed in the laboratory and accuracy on College of American Pathologists proficiency tests. A significant positive Spearman rs correlation confirmed a relationship between employing a higher proportion of certified medical technologists and accuracy of test results.

Certification↗
PubMed2002

Effect of a common reference plasma on the inter-laboratory variation of the measurement of total and free protein S: a collaborative study of the Dutch Working Group on Haemostasis Laboratory Diagnosis.

The comparability of test results for protein S between laboratories is hampered by a high inter-laboratory variability. The effect of the use and type of common reference plasma on the inter-laboratory variability of the total and free protein S measurement was evaluated. The results of 10 plasma samples measured against a centrally distributed frozen plasma and a centrally distributed lyophilized plasma were compared with those of various local reference plasmas regularly used by the 11 participating laboratories. The mean intra-assay coefficient of variation for total protein S in each laboratory varied from 3.8 to 12.8% (mean intra-assay CV of all laboratories: 7.4+/-2.3%); for free protein S this range was 3.1 to 13.3% (mean intra-assay CV of all laboratories: 6.6+/-2.7%). We confirmed the high inter-laboratory coefficient of variation (mean+/-SD) with the several local reference plasmas for both total protein S (13.4+/-5.6%; n = 10) and free protein S (17.1+/-7.5%: n = 11). For total protein S, the inter-laboratory CV was reduced to 11.5+/-4.8%, (p=0.05) by using a common frozen reference plasma, while it was increased to 16.8+/-3.4%, (p=0.022) using a common lyophilized reference plasma. For free protein S, these values decreased only statistically significantly for the common lyophilized reference plasma, to 15.1+/-6.0%, (p = 0.008). For free protein S, the dilution factor used was identified as a factor influencing the inter-laboratory variability. This study shows that, for both types of protein S measurements, using one frozen reference plasma shows a slight decrease in inter-laboratory variability, while a common lyophilized plasma shows inconsistent results. It is concluded that further investigation is necessary to examine other sources of variability to increase the comparability of laboratory results for both total and free protein S.

Adult↗
PubMed1997

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.

Bacteriological Techniques↗
PubMed1992

Certification of cholesterol measurements by the National Reference Method Laboratory Network with routine clinical specimens: effects of network laboratory bias and imprecision.

The National Reference Method Laboratory Network has initiated a program to certify clinical laboratory cholesterol measurement performance by using routine clinical specimens. Clinical laboratory and reference laboratory measurements of split samples are used to assess whether the clinical laboratory is meeting the Laboratory Standardization Panel's goals for accuracy and precision. We used a computer-based Monte Carlo simulation model of split-sample proficiency testing to evaluate the certification program and, in particular, to analyze the effects of reference laboratory bias and imprecision. Results of our simulations indicate that the accuracy of the certification program is strongly influenced by reference laboratory bias and less influenced by reference laboratory imprecision. The certification program is potentially highly accurate, but unless reference laboratory bias is tightly controlled, the number of classification errors may limit its utility. Moreover, the decision limit of the certification program needs to be higher than the Laboratory Standardization Panel's goal (3.5% instead of 3.0%) to ensure that an acceptably high proportion of well-performing clinical laboratories can become certified.

Certification↗
PubMed2002

Proficiency of Italian clinical laboratories in detecting reduced glycopeptide susceptibility in Enterococcus and Staphylococcus spp. using routine laboratory methodologies.

OBJECTIVE: To assess the ability of 59 clinical microbiology laboratories distributed throughout Italy to correctly identify and detect reduced susceptibility to glycopeptides in staphylococci and VanA-, VanB- or VanC-mediated glycopeptide resistance in enterococci. METHODS: Eight test strains comprising three staphylococci (S. aureus ATCC 29212 and two vancomycin-intermediate S. haemolyticus [11105301, 10030683Y]) and five enterococci (E. faecalis ATCC 29212, E. faecalis ATCC 51299 VanB, E. faecium AIB40 VanA, E. faecalis V583 VanB and E. gallinarum AIB39 VanC1) were distributed to 59 Italian clinical microbiology laboratories. Each isolate was blind-coded, and laboratories were instructed to identify the strains and test isolates for susceptibility to teicoplanin and vancomycin using their standard methods. Results were assessed against consensus test results obtained by a reference laboratory. In addition, to complement data interpretation, laboratories were asked to provide retrospective routine test results from their respective hospitals. RESULTS: All 59 laboratories participating in the study completed the susceptibility testing and provided data for analysis. A total of 53 laboratories provided retrospective routine data. Overall, laboratories were able to identify isolates to the genus level successfully. E. gallinarum and S. haemolyticus posed problems for species identification, with only 40.6 and 71.2%, respectively, of results reported correctly; most incorrect results were reported as 'other species'. For enterococcal test strains, VanA phenotypes were detected correctly by 96.6% of laboratories; VanB by 30.5% (E. faecalis ATCC 51299) and 88.1% (E. faecalis V583); and VanC1 by 67.8%. For staphylococcal test strains, 28.8% (S. haemolyticus 11105301) and 23.7% (S. haemolyticus 10030683Y) of the laboratories were able to detect reduced susceptibility to vancomycin. Errors in detecting vancomycin resistance in VanB and VanC1 enterococci were made with all methods, most noticeably by disk diffusion users. For staphylococci, most errors in reporting vancomycin-intermediate resistance occurred with disk diffusion and Vitek (software version 5.04) users. Overall, considerably fewer errors occurred with the detection of teicoplanin resistance, especially for staphylococci. For 1999, routine results show that 41/1749 (2.4%) of E. faecium, 220/11 180 (2.0%) of E. faecalis, 29/24 927 (0.12%) of S. aureus and 54/22 102 (0.24%) of coagulase-negative staphylococci were reported as resistant to vancomycin. CONCLUSION: Italian laboratories are able to identify staphylococci and enterococci adequately, although all methodologies used have problems in identifying E. gallinarum and coagulase-negative staphylococci to the species level. While VanA phenotypes were efficiently detected, problems were experienced in detecting VanB and VanC phenotypes. The majority of laboratories were unable to detect reduced vancomycin susceptibility in staphylococci adequately, especially with disk diffusion and older Vitek systems. Teicoplanin appeared useful as a marker for detecting vancomycin resistance, particularly with disk diffusion. Should enterococcal VanB or staphylococcal glycopeptide-intermediate phenotypes become prevalent in Italy, it is likely that they would be under-detected. New systems under development, such as Vitek2, should improve this situation.

Anti-Bacterial Agents↗
PubMed1997

Log-in/log-out time: a quality factor for a reference laboratory--prolonged times for skin pathology processing in managed care-authorized laboratories.

Managed care organizations may divert skin biopsy specimens to commercial laboratories selected on a cost basis. Diversion to these laboratories could result in service of decreased quality for the patient and referring physician. Log-in/log-out dates were collected for all specimens submitted to managed care-authorized laboratories either from a university-based clinic or from a private practitioner's office for a period of 18 months and compared with data obtained from a local dermatopathology laboratory. A subgroup of specimens containing inflammatory diagnoses or nondiagnostic changes was also examined. Mean log-in/log-out times were 1.338 days in the dermatopathology laboratory, 6.123 days in managed care-authorized laboratories from the university site, and 7.798 days in managed care-authorized laboratories from a practitioner's office. The differences between the dermatopathology laboratory log-in/log-out times and those of the managed care-authorized laboratories were statistically significant (p < 0.0001). The conclusion from this study is that a quality indicator defined as time from log in to log out revealed a significant increase in interpretation time at managed care-designated laboratories. Although managed care plans can decrease their financial risk by contracting with national laboratories to provide all services for a set fee, a decreased quality of service can be demonstrated.

Biopsy↗