Reporting of Vancomycin-Resistant Enterococci in Connecticut: Implementation and Validation of a State-Based Surveillance System

1999 ◽  
Vol 20 (10) ◽  
pp. 671-675 ◽  
Author(s):  
Zygmunt F. Dembek ◽  
Scott E. Kellerman ◽  
Lisa Ganley ◽  
Constance M. Capacchione ◽  
Fred C. Tenover ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Proficiency Testing ◽  
Clinical Laboratory ◽  
Surveillance Systems ◽  
Passive Surveillance ◽  
Emerging Pathogens ◽  
Clinical Laboratories ◽  
Vancomycin Resistant Enterococci ◽  
Vancomycin Resistant

AbstractObjective:To assess state-based surveillance for isolation from a sterile site of vancomycin-resistant enterococci (VRE) in Connecticut.Design:Clinical laboratory reporting (passive surveillance) of VRE isolates to the Connecticut Department of Public Health (CDPH) was followed by state-initiated validation, laboratory proficiency testing, and review of hospital demographic characteristics.Settings:All 45 clinical laboratories and all 37 (36 for 1995 and 1996) acute-care hospitals in Connecticut were included in the study.Main Outcome Measures:The outcome measures included determination of the statewide incidence of VRE and the accuracy of passive reporting, determination of clinical laboratory proficiency in detecting VRE, and analysis of hospital characteristics that might be associated with an increased incidence of VRE.Results:During 1994 through 1996, 29 (78%) of 37 hospital-affiliated clinical laboratories and 1 (11%) of 9 commercial or other laboratories in Connecticut reported to the CDPH the isolation of VRE from sterile sites; 158 isolates were reported for these 3 years. Based on verification, we discovered that these laboratories actually detected 58 VRE isolates in 1994, 104 in 1995, and 104 in 1996 (total, 266). The age-standardized incidence rate of VRE was 14.1 cases per million population in 1994 and 26.8 cases per million population for both 1995 and 1996. Laboratory proficiency testing revealed that high-level vancomycin resistance was identified accurately and that low- and moderate-level resistance was not detected. The incidence of VRE isolates was three times greater in hospitals with over 300 beds compared with categories of hospitals with fewer beds. Increases in the number of VRE isolates were at least twice as likely in hospitals located in areas with a higher population density, or with a residency program or trauma center in the hospital.Conclusions:Passive reporting of VRE isolates from sterile sites markedly underestimated the actual number of isolates, as determined in a statewide reporting system. Statewide passive surveillance systems for routine or emerging pathogens must be validated and laboratory proficiency ensured if results are to be accurate and substantial underreporting is to be corrected.

Are clinical laboratories in California accurately reporting vancomycin-resistant enterococci?

1997 ◽  
Vol 35 (10) ◽  
pp. 2526-2530 ◽  
Author(s):  
J Rosenberg ◽  
F C Tenover ◽  
J Wong ◽  
W Jarvis ◽  
D J Vugia
Keyword(s):  
Clinical Laboratories ◽  
Vancomycin Resistant Enterococci ◽  
Vancomycin Resistant

Limitations of Proficiency Testing Under CLIA '67

1992 ◽  
Vol 38 (7) ◽  
pp. 1237-1244 ◽  
Author(s):  
R H Laessig ◽  
S S Ehrmeyer ◽  
B J Lanphear ◽  
B J Burmeister ◽  
D J Hassemer
Keyword(s):  
Health Care ◽  
Quality Assurance ◽  
Proficiency Testing ◽  
Clinical Laboratory ◽  
Health Care Financing ◽  
Clinical Laboratories ◽  
Regulatory Strategy ◽  
Clinical Laboratory Improvement Amendments ◽  
Quality Improvement Tool

Abstract Proficiency testing (PT), recognized as a quality-assurance (QA) and quality-improvement tool, also has become the cornerstone of the Health Care Financing Administration's (HCFA) regulatory strategy under the revised Clinical Laboratory Improvement Act of 1967 (CLIA '67) and the proposed Clinical Laboratory Improvement Amendments of 1988 (CLIA '88). Use of PT as a regulatory tool corrupts it for things it can do better. PT as a primary regulatory strategy has severe limitations. We explore the nature of these limitations and their implications for clinical laboratories as they impact on the long-term success of HCFA's approved regulatory PT programs in 1991 and beyond, and CLIA '88 PT, which is to be implemented in 1994.

scholarly journals Evaluation of Blood Lead Proficiency Testing: Comparison of Open and Blind Paradigms

2001 ◽  
Vol 47 (2) ◽  
pp. 322-330 ◽  
Author(s):  
Patrick J Parsons ◽  
Andrew A Reilly ◽  
Debra Esernio-Jenssen ◽  
Lloyd N Werk ◽  
Howard C Mofenson ◽  
...  
Keyword(s):  
New York ◽  
Proficiency Testing ◽  
Clinical Laboratory ◽  
Phase 1 ◽  
New York State ◽  
Blood Lead ◽  
York State Department ◽  
Clinical Laboratories ◽  
Significant Difference ◽  
Double Blinded

Abstract Background: Most proficiency testing (PT) programs operate with an open design in which clearly identified performance samples are distributed directly to participating laboratories on a shipping schedule announced in advance. In this study, we examine the effectiveness of assessing clinical laboratory performance for blood lead with an open PT by comparing its results with a double-blinded testing protocol. Methods: Aliquots from up to 72 blood lead performance pools from the New York State Department of Health and the Wisconsin State Laboratory of Hygiene were disguised as routine patient specimens and submitted in two phases to up to 42 certified clinical laboratories for blood lead analysis. These 42 laboratories also received aliquots of the same performance samples for blood lead analysis directly from the “open” PT program provider. Results: Data reported under blind and open strategies were scored against acceptable target ranges using the Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88) criteria established for blood lead, i.e., ± 0.19 μmol/L (± 4 μg/dL) or ± 10%, whichever is greater. Performance differences between the strategies were also assessed. We found that 17.7% of all blind PT results were classified as unacceptable compared with only 4.5% of open PT results (P <0.001). In phase 1, 13 of 22 laboratories (60%) exhibited a statistically significant difference (P <0.05) between their blind and open PT performances, although for 6 laboratories the poorer blind performance may not necessarily have led to unsuccessful PT participation under CLIA ’88 criteria. Seven (32%) laboratories had unsuccessful aggregate performance (<80%) under blind testing while maintaining successful performance in open testing. Of these seven, two had gross discrepancies motivating further investigation. Conclusions: The data suggest that although ∼60% of clinical laboratories make special efforts to improve analytical performance on open PT samples relative to performance achieved for routine patient specimens, in most cases the differences are clinically insignificant and would not likely affect cumulative PT performance. Occasional use of blind PT may deter the inclination to treat performance samples more carefully.

scholarly journals Enterococci: Between Emerging Pathogens and Potential Probiotics

2019 ◽  
Vol 2019 ◽  
pp. 1-13 ◽  
Author(s):  
Olfa Ben Braïek ◽  
Slim Smaoui
Keyword(s):  
Live Cells ◽  
Emerging Pathogens ◽  
Plant Soil ◽  
Vancomycin Resistant Enterococci ◽  
Water Plant ◽  
Proteolytic Activities ◽  
Vancomycin Resistant ◽  
Points Of View ◽  
Transfer Mechanisms ◽  
Stimulation Of

Enterococci are ubiquitous microorganisms that could be found everywhere; in water, plant, soil, foods, and gastrointestinal tract of humans and animals. They were previously used as starters in food fermentation due to their biotechnological traits (enzymatic and proteolytic activities) or protective cultures in food biopreservation due to their produced antimicrobial bacteriocins called enterocins or as probiotics, live cells with different beneficial characteristics such as stimulation of immunity, anti-inflammatory activity, hypocholesterolemic effect, and prevention/treatment of some diseases. However, in the last years, the use of enterococci in foods or as probiotics caused an important debate because of their opportunistic pathogenicity implicated in several nosocomial infections due to virulence factors and antibiotic resistance, particularly the emergence of vancomycin-resistant enterococci. These virulence traits of some enterococci are associated with genetic transfer mechanisms. Therefore, the development of new enterococcal probiotics needs a strict assessment with regard to safety aspects for selecting the truly harmless enterococcal strains for safe applications. This review tries to give some data of the different points of view about this question.

scholarly journals Improved RT-PCR SARS-Cov2 results interpretation by indirect determination of cut-off cycle threshold value

2020 ◽  
Author(s):  
Khelil Mohamed Mokhtar
Keyword(s):  
Real Time ◽  
Clinical Laboratory ◽  
Threshold Value ◽  
Mixed Data ◽  
Rt Pcr ◽  
Data Set ◽  
Iso 15189 ◽  
Indirect Determination ◽  
Clinical Laboratories

ABSTRACTClinical laboratories of the developing world are overwhelmed with RT-PCR SARS-Cov2 testing demands. It is of paramount importance that each clinical laboratory use an appropriate cut-off value in the interpretation of SARS-Cov2 real-time RT–PCR results, which is specific to their laboratory performances as ISO 15189 recommendations stipulate. We applied an indirect statistical method to a large mixed data set of Ct values (ORF1ab and N) to estimate cut-off Ct value (∼32 cycles).we conclude that the use of indirect statistical approaches to estimate cut-off value in the interpretation of SARS-Cov2 real-time RT–PCR results may improve differential diagnosis of COVID-19 cases with low risk of infectivity, and may help to better estimates of the burden of COVID-19 disease.

scholarly journals Optimizing the Dosing Regimens of Daptomycin Based on the Susceptible Dose-Dependent Breakpoint against Vancomycin-Resistant Enterococci Infection

Antibiotics ◽  
2019 ◽  
Vol 8 (4) ◽  
pp. 245 ◽  
Author(s):  
Wichai Santimaleeworagun ◽  
Dhitiwat Changpradub ◽  
Sudaluck Thunyaharn ◽  
Jatapat Hemapanpairoa
Keyword(s):  
Steady State ◽  
Area Under The Curve ◽  
Minimum Concentration ◽  
Vancomycin Resistant Enterococci ◽  
Dosing Regimens ◽  
Low Probability ◽  
Vancomycin Resistant ◽  
Lipopeptide Antibiotic ◽  
Dose Dependent

Daptomycin, a lipopeptide antibiotic, is one of the therapeutic options used for the treatment of vancomycin-resistant enterococci (VRE). Recently, the Clinical and Laboratory Standards Institute (CLSI) M100 30th edition has removed the susceptibility (S) breakpoint for Enterococcus faecium and replaced it with a susceptible dose-dependent (SDD) breakpoint of ≤4 μg/mL, with a suggested dosage of 8–12 mg/kg/day. Herein, we aimed to determine the minimum inhibitory concentration (MIC) values of daptomycin against clinical VRE isolates and to study the appropriate daptomycin dosing regimens among critically ill patients based on the new susceptibility CLSI breakpoint. The MIC determination of daptomycin was performed using E-test strips among clinical VRE strains isolated from patients at the Phramongkutklao Hospital. We used Monte Carlo simulation to calculate the probability of target attainment (PTA) and the cumulative fraction of response (CFR) of the ratio of the free area under the curve to MIC (fAUC0–24/MIC) > 27.4 and fAUC0–24/MIC > 20 for survival and microbiological response, respectively, at the first day and steady state. Further, we determined that the simulated daptomycin dosing regimen met the minimum concentration (Cmin) requirements for safety of being below 24.3 mg/L. All of the 48 VRE isolates were E. faecium strains, and the percentiles at the 50th and 90th MIC of daptomycin were 1 and 1.5 μg/mL, respectively. At MIC ≤ 2 μg/mL, a daptomycin dosage of 12 mg/kg/day achieved the PTA target of survival and microbiological response at the first 24 h time point and steady state. For a MIC of 4 μg/mL, none of the dosage regimens achieved the PTA target. For CFR, a dosage of 8–12 mg/kg/day could achieve the 90% CFR target at the first day and steady state. All dosing regimens had a low probability of Cmin being greater than 24.3 mg/L. In conclusion, the MIC of VRE against daptomycin is quite low, and loading and maintenance doses with 8 mg/kg/day were determined to be optimal and safe.

scholarly journals Test Verification and Validation for Molecular Diagnostic Assays

2012 ◽  
Vol 136 (1) ◽  
pp. 11-13 ◽  
Author(s):  
Kevin C Halling ◽  
Iris Schrijver ◽  
Diane L Persons
Keyword(s):  
Clinical Laboratory ◽  
Molecular Diagnostic ◽  
Molecular Assay ◽  
Validation And Verification ◽  
Diagnostic Assays ◽  
Molecular Assays ◽  
Clinical Laboratories ◽  
Hereditary Disorders ◽  
Test Verification

With our ever-increasing understanding of the molecular basis of disease, clinical laboratories are implementing a variety of molecular diagnostic tests to aid in the diagnosis of hereditary disorders, detection and monitoring of cancer, determination of prognosis and guidance for cancer therapy, and detection and monitoring of infectious diseases. Before introducing any new test into the clinical laboratory, the performance characteristics of the assay must be “verified,” if it is a US Food and Drug Administration (FDA)–approved or FDA-cleared test, or “validated,” if it is a laboratory-developed test. Although guidelines exist for how validation and verification studies may be addressed for molecular assays, the specific details of the approach used by individual laboratories is rarely published. Many laboratories, especially those introducing new types of molecular assays, would welcome additional guidance, especially in the form of specific examples, on the process of preparing a new molecular assay for clinical use.

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