This document outlines a comprehensive practical approach to a laboratory quality management system (QMS) by describing how to operationalize the management and technical requirements described in the ISO 15189 international standard. It provides a crosswalk of the ISO requirements for quality and competence for medical laboratories to the 12 quality system essentials delineated by the Clinical and Laboratory Standards Institute. The quality principles are organized under three main categories: quality infrastructure, laboratory operations, and quality assurance and continual improvement.
View Article and Find Full Text PDFThe aim of this study is to document the isolation of a hypermucoviscosity (HMV) phenotype of Klebsiella pneumoniae from 25 cases of suppurative pneumonia and pleuritis and two cases of abscesses in California sea lions (Zalophus californianus) from the central California coast, representing the first report of this zoonotic pathogen from the marine environment and only the second report in non-humans. Animals died 2h to 4 days after first being observed sick on beaches. Clinical signs varied from dyspnoea to coma.
View Article and Find Full Text PDFWe compared the results obtained with six commercial MIC test systems (Etest, MicroScan, Phoenix, Sensititre, Vitek Legacy, and Vitek 2 systems) and three reference methods (agar dilution, disk diffusion, and vancomycin [VA] agar screen [VScr]) with the results obtained by the Clinical and Laboratory Standards Institute broth microdilution (BMD) reference method for the detection of VA-intermediate Staphylococcus aureus (VISA). A total of 129 S. aureus isolates (VA MICs by previous BMD tests,
This study characterizes methicillin-susceptible Staphylococcus aureus (MSSA) and methicillin-resistant S. aureus (MRSA) isolates recovered from nasal cultures of noninstitutionalized individuals in the United States obtained in 2001 to 2004 as part of the National Health and Nutrition Examination Survey. Every tenth MSSA isolate and all MRSA isolates were typed by pulsed-field gel electrophoresis (PFGE), screened for multiple toxin genes, and tested for susceptibility to 14 antimicrobial agents.
View Article and Find Full Text PDFContext: As the epidemiology of infections with methicillin-resistant Staphylococcus aureus (MRSA) changes, accurate information on the scope and magnitude of MRSA infections in the US population is needed.
Objectives: To describe the incidence and distribution of invasive MRSA disease in 9 US communities and to estimate the burden of invasive MRSA infections in the United States in 2005.
Design And Setting: Active, population-based surveillance for invasive MRSA in 9 sites participating in the Active Bacterial Core surveillance (ABCs)/Emerging Infections Program Network from July 2004 through December 2005.
A challenge panel of enterococci (n = 50) and staphylococci (n = 50), including 17 and 15 isolates that were nonsusceptible to linezolid, respectively, were tested with the Clinical and Laboratory Standards Institute broth microdilution and disk diffusion reference methods. In addition, all 100 isolates were tested in parallel by Etest (AB Biodisk, Solna, Sweden), MicroScan WalkAway (Dade, West Sacramento, CA), BD Phoenix (BD Diagnostic Systems, Sparks, MD), VITEK (bioMérieux, Durham, NC), and VITEK 2 (bioMérieux) by using the manufacturers' protocols. Compared to the results of the broth microdilution method for detecting linezolid-nonsusceptible staphylococci and enterococci, MicroScan results showed the highest category agreement (96.
View Article and Find Full Text PDFDetecting beta-lactamase-mediated carbapenem resistance among Klebsiella pneumoniae isolates and other Enterobacteriaceae is an emerging problem. In this study, 15 blaKPC-positive Klebsiella pneumoniae that showed discrepant results for imipenem and meropenem from 4 New York City hospitals were characterized by isoelectric focusing; broth microdilution (BMD); disk diffusion (DD); and MicroScan, Phoenix, Sensititre, VITEK, and VITEK 2 automated systems. All 15 isolates were either intermediate or resistant to imipenem and meropenem by BMD; 1 was susceptible to imipenem by DD.
View Article and Find Full Text PDFBackground: Methicillin-resistant Staphylococcus aureus (MRSA) is increasingly recognized in infections among persons in the community without established risk factors for MRSA.
Methods: We enrolled adult patients with acute, purulent skin and soft-tissue infections presenting to 11 university-affiliated emergency departments during the month of August 2004. Cultures were obtained, and clinical information was collected.
We evaluated the accuracy of an erythromycin-clindamycin double-disk test (D-zone test) and an erythromycin-telithromycin D-zone test for detection of inducible resistance in isolates of beta-hemolytic streptococci with erythromycin resistance. The results of these tests were compared to results of a broth microdilution (BMD) induction test using combinations of erythromycin and either clindamycin or telithromycin. Of 29 erythromycin-resistant, clindamycin-susceptible isolates, 16 were positive by the erythromycin-clindamycin D-zone test; all of these demonstrated inducible clindamycin resistance by BMD.
View Article and Find Full Text PDFObjectives: Tube feeding might increase gastric burden of pathogenic bacteria and predispose patients to ventilator-associated pneumonia. We sought to determine whether a tube feeding formula acidified using potassium sorbate could reduce gastric burden of potentially pathogenic bacteria.
Design: Prospective, randomized, double-blind trial.
Tuberculous tenosynovitis is rare and may be overlooked as a cause of chronic tenosynovitis. This report presents a case of a young woman with tuberculosis tenosynovitis of the wrist, and highlights the clinical, imaging, histological, and laboratory features most commonly seen in this disease.
View Article and Find Full Text PDFContext: Cases of fatal hemorrhagic pneumonia need to be investigated for highly contagious viral causes. While not all hemorrhagic pneumonias are caused by very contagious agents, the etiology must be correctly determined in order to administer appropriate patient care.
Objective: To determine whether chlamydia, paramyxovirus, or mycoplasma was the causative agent in a case of fatal hemorrhagic pneumonia, and to evaluate the possibility that this was the first case of hantavirus pulmonary syndrome in Illinois.
Purpose: To evaluate Staphylococcus epidermidis adherence to human amniotic membrane (HAM) and compare it with S epidermidis adherence to human, rabbit, and cat conjunctiva in vitro.
Setting: Research laboratory, Loyola University Medical Center, Maywood, Illinois, USA.
Methods: Commercially available HAM (N = 3) was used.
Purpose: To study bacterial adherence to processed dura mater, processed pericardium, pericardium in saline, and human sclera and the difference in bacterial adherence to these tissues.
Setting: Research Laboratory, Loyola University Medical Center, Maywood, Illinois, USA.
Methods: Specimens of processed dura mater, processed human pericardium, pericardium in saline, and human sclera (N = 32) were exposed to Staphylococcus epidermidis (concentration 3 x 10(8)) for 10, 20, 40, and 60 minutes, washed for 5 seconds, fixed, and processed for scanning electron microscopy (SEM).