Clinical Laboratory Improvement Advisory Committee

Total Page:16

File Type:pdf, Size:1020Kb

Clinical Laboratory Improvement Advisory Committee Clinical Laboratory Improvement Advisory Committee Meeting Transcript April 10-11, 2019 Baltimore, Maryland U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES 1 April 10, 2019 Call to Order and Committee Member Introductions CLIAC CHAIR: Well everybody, I'll ask committee members to take your seats as we prepare to begin the meeting. Do we have quorum? I think we have quorum. CLIAC DFO: Good morning, and welcome to CLIAC. I'd like to take this opportunity to thank our hosts at CMS. This is a great opportunity. It's the first time in CLIAC's history that we have held this meeting at CMS. So it's a great opportunity for us. We begin with introductions and conflicts of interest. And we'd like for each CLIAC member, beginning with Campbell, to introduce themselves, provide just their affiliation, as well as their indication of any conflicts of interest. And we'll go around the table. So we'll take care of introductions and conflicts of interest at the same time. CLIAC MEMBER: I'm Sheldon Campbell from Yale School of Medicine and VA Connecticut Healthcare. I'm on College of American Pathologists Checklists Committee, the Lab Practices Committee of the American Society for Microbiology, and no other conflicts of interest. CLIAC MEMBER: I'm Marc Couturier from University of Utah, ARUP Laboratories. I am also on the Clinical Laboratory Practices Committee through the American Society for Microbiology. I have a financial conflict of interest with BioFire Diagnostics, for which my spouse draws a household income. And I have a conflict of interest for research reagents with Apacor Limited, Meridian Biosciences, and DSORG. CLIAC MEMBER: Good Morning. I'm Lee Hilborne. I am a Medical Director at Quest Diagnostics. That's probably my major conflict of interest. I'm also a professor and Medical Director at UCLA Healthcare. I am on the CAP Accreditation Education Committee, and am on the Commission on Public Policy for ASCP, and then past president of ASCP. I also work for Rand, but they're nonprofit. CLIAC MEMBER Morning. Steve Hinrichs. I'm Chair and Professor of the Department of Pathology at University of Nebraska Medical Center. We are heavily engaged in both research and education, but I have no other financial conflicts. CLIAC MEMBER: I'm Brad Karon. I'm at the Mayo Clinic in Rochester, Minnesota. Clinical pathologist. I am a member of the College of American Pathologists Council on Accreditation. And I have financial conflicts of interest-- I serve on advisory boards for Roche Diagnostics and Radiometer America. CLIAC MEMBER: Good morning. Tom Lorey. I'm the Regional Medical Director of Northern California region of Kaiser Permanente. I have no conflicts, financial or otherwise. CLIAC MEMBER: Good morning. My name is Sharon Massingale and I'm the Laboratory Director for the State of Alabama Bureau of Clinical Laboratories. I'm a member of ABB, where I serve as a representative to the public health interest group. And I'm also part of APHL where I'm a member of the workforce development group. And my laboratory received funds for two cooperative agreements from the CDC. 2 CLIAC MEMBER: Good morning. I'm Lavinia Middleton. I'm a surgical pathologist by training at MD Anderson Cancer Center. I am the Vice Chair for Quality Operations in the Division of Path and Lab Medicine. And I'm also the Deputy CMO for Medical Affairs. I sit on the AAMC Diagnostic Accuracy Committee. And I have no financial conflicts. CLIAC MEMBER: Hello. I'm Helen Mills from Victor 12 in the VA of Orlando, Florida. I have no conflicts at this time. CLIAC MEMBER: Good morning. I'm Valerie Ng. I'm Professor Emeritus of the Department of Laboratory Medicine at the University of California, San Francisco. And I'm currently Chair of the Department of Lab Medicine and Pathology at Alameda Health System in Alameda County, Oakland, California. I'm a member of the Health Laboratory Workforce Initiative Advisory Group for the California Hospital Association. I am a reviewer for the College of American Pathologists Point of Care Checklist. I am a reviewer for the Gordon and Betty Moore Inventors Fellows submissions this year. And I'm the Editorial Lead for Lab Medicine for Doody's Books Reviews. Thank you. CLIAC MEMBER: Good morning. My name is Katherine Perez. I'm the Infectious Diseases Pharmacist in Houston Methodist Hospital System. I direct the antimicrobial [INAUDIBLE]. CLIAC MEMBER: Good morning. I'm Bonnie Rubin, and I'm currently an Adjunct Professor at University of Iowa [INAUDIBLE] college. And my only conflict of interest is that I'm on the Board [INAUDIBLE]. CLIAC MEMBER: Good morning. Greg Sossaman. I'm a clinical biologist at Oshner Health System in New Orleans. I have no financial conflicts. I have held several volunteer positions through ASCE. CLIAC MEMBER: Hello. My name is Cindy Wilkerson. I'm the Director of the Laboratory Medicine Department at the Sloan Kettering Cancer Center in New York City, and I have no conflicts. CLIAC MEMBER: Good morning. I'm Donna Wolk. I'm the Division Director and Laboratory Medicine at Geisinger Health, and an adjunct professor at Wilkes University. I have grant-funded financial conflicts with Roche, GenMark, Upjohn, CEPHIA, DiaSorin, BioFire, and I hold advisory positions with Streck and Safeguard. I also have a CBC-funded pandemic flu grant through ABT, and I'm the editor for "The Clinical Microbiology" newsletter from Elsevier. ADVAMED LIAISON: Good morning. I'm Andy Quintenz, and I am a liaison to the CLIAC, and from Biroad Laboratories. I'm also the chair of the ISO technical committee for the US executive committee for TC-212, which is clinical lab testing. And members of the AACC corporate advisory board and CLSI consensus council. CLIAC EXECUTIVE SECRETARY: Good morning. I'm Nancy Anderson from the Division of Laboratory Systems at CDC. I'm the Executive Secretary for CLIAC and I have no conflicts. CDC EX OFFICIO: Good morning, everyone. I'm CDC EX OFFICIO Fitzgerald. I'm in the Division of Laboratory Systems at CDC. I'm the CDC Ex Officio for CLIAC. I have no conflicts of interest. CLIAC DFO: Good morning. I'm Ren Salerno from CDC's Division of Laboratory Systems, and I'm the designated Federal Official for CLIAC. No conflicts. CMS EX OFFICIO: And I'm CMS EX OFFICIO Dyer. I'm the Director of Division of Clinical Laboratory Improvement here at CMS, and I have no conflicts. 3 FDA EX OFFICIO: Good morning. I'm Peter Tobin from the Office of In Vitro Diagnostics and Radiological Health at FDA, and I have no conflicts of interest. CLIAC CHAIR: And we have-- I believe we have Dr. Williams on the phone. Thomas Williams, are you on the phone? Susan Gross, are you on the phone? Is anybody on the phone? Do we have anybody on the phone? CLIAC MEMBER: I'm Susan Gross. I am the Medical Director of the Reproductive Genetic Laboratory at Sema4. And I'm also a professor at the Genomics Department at Icahn School of Medicine, Mount Sinai. My other conflicts to say today, I am a consultant at [INAUDIBLE], which is an artificial intelligence software company for genomic medicine for interpretation and complication variance. And I'm also the President of the OBG project, which is a peer to peer educational online site. CLIAC CHAIR: Thank you, Dr. Gross. Do we have Dr. Laser on the phone? Well, that brings us to me. I'm Ramy Arnaout. I'm the Medical Director of Clinical Microbiology at Beth Israel Deaconess Medical Center and Harvard Medical School up in Boston. I consult for Lexent Bio, a cell-free DNA diagnostics company, and Embold Health, a health care analytics company. I also sit on the informatics and personalized medicine committees for CAP, for the College for American Pathologists. And with that, I think we will get started So about public comments. So during the period for committee discussion, participation is limited to CLIAC members. However, public comment periods are scheduled for both meeting days. Public comments will be limited to a total time of five minutes per individual or group. And we've got a pretty dense couple of days, so we do appreciate it for public commenters keeping to that. If anyone in the audience wishes to address the committee, the public comment portion of the meeting is the proper forum to do so. Those who are planning to provide a public comment must fill out a speaker information form located at the registration desk. And again, please do restrict your oral comments to five minutes. Can I get a show of hands for any public comments today? OK. Somebody help me count. I count three. OK, fantastic. Thank you very much. And could you, three of you, please indicate which topics your comments will relate to. Just yell it out. AUDIENCE: Proficiency testing. CLIAC CHAIR: Moving across the room, who's the second hand? AUDIENCE: [INAUDIBLE]. CLIAC CHAIR: Which one? AUDIENCE: Sorry. CLIAC CHAIR: No worries. Take your time. AUDIENCE: [INAUDIBLE]. CLIAC CHAIR: Personnel? Personnel. OK. Thanks. And the third one? AUDIENCE: Personnel qualifications. 4 CLIAC CHAIR: Thanks all three of you. All right. Copies of all our PowerPoint presentations and other meeting materials are posted on the CLIAC website. It's www.cdc.com/cliac. Everybody should be able to get into our guest wireless here. If you have any trouble, turn to your neighbors who can help you out. At the start of each presentation, I will do my best to remember to announce a presentation number to assist you in locating the correct electronic file.
Recommended publications
  • Supplementary TABLE 1
    Note: This is Online Supplementary Document 1 of Koster W, Ndione AG, Adama M, et al. An oral history of medical laboratory development in francophone West African countries. Afr J Lab Med. 2021;10(1), a1157. https://doi.org/10.4102/ajlm.v10i1.1157 Supplementary TABLE 1: Physical places where literature was accessed [BR1] Country/city Place where documents were accessed Burkina Faso, Unité de Formation et de Recherche en sciences de la santé (UFR/SDS) de Ouagadougou l’université Ouaga 1 Professeur Joseph Ki Zerbo Centre National de Recherche Scientifique et Technologique (CNRST) Ecole National de Santé Publique (ENSP), Direction générale Union Monétaire des États de l’Afrique de l’Ouest (UEMOA) Institut de Recherche en Développement (IRD) Organisation mondiale de la Santé (OMS) au Burkina Faso Burkina Faso, Ecole National de Santé Publique (ENSP), Direction régionale Bobo Dioulasso Centre Muraz L’Organisation Ouest Africaine de la Santé (OAAS) Mali Institut National de Recherche en Santé Publique (INRSP) Bamako Bibliothèque nationale Archives nationales Centre National d’Appui à la lutte contre la Maladie (CNAM) ex-Institut Marchoux Faculté de Médecine et d’Odonto- Stomatologie et Faculté de Pharmacie Direction Nationale de la Santé (DNS) Direction de la Pharmacie et du Médicament (DPM) Pharmacie Populaire du Mali (PPM) Institut National de Formation en Sciences de la Santé (INFSS) Inspection de la santé Organisation mondiale de la Santé (OMS) à Bamako Senegal Bibliothèque universitaire de Dakar Dakar Assemblée Nationale du Sénégal Agence
    [Show full text]
  • Advanced Non-Small Cell Lung Cancer: Retrospective Study Of
    i e r Sc c nce e a c n an d C R f Journal of Cancer Science and e o s l e a a n r r c EL-Hadaad et al., J Can Sci Res 2017, 3:S1 h u o J Research DOI: 10.4172/2576-1447.1000S1-011 ISSN: 2576-1447 Research Article Open Access Advanced Non-Small Cell Lung Cancer: Retrospective Study of Prognostic Factors Hend A EL-Hadaad1*, Yasser M Saleh1, Hanan A Wahba1 and Magda A Ahmad2 1Department of Clinical Oncology& Nuclear Medicine, Mansoura University, Egypt 2Chest Medicine department, Mansoura University, Egypt *Corresponding author: Dr. Hend Ahmed El-Hadaad, MD, Faculty of medicine, University of Mansoura, Egypt, Tel: +20124272772; E-mail: [email protected] Received date: March 09, 2017; Accepted date: March 28, 2017; Published date: March 31, 2017 Copyright: © 2017 EL-Hadaad HA, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Abstract Objective: The objective of the study is to investigate and improve our understanding of the impact of several potential prognostic factors on overall survival (OS) in patients with advanced non-small cell lung cancer (NSCLC). Methods: Records of patients with advanced NSCLC (stage IIIB, IV) received first-line chemotherapy were reviewed. Age, gender, Eastern Cooperative Oncology Group performance status (ECOGPS), stage, histologic type, smoking status, leucocytic count, type of chemotherapy, albumin and hemoglobin level were evaluated for their prognostic significance in multivariate analysis.
    [Show full text]
  • Medical Laboratory and Diagnosis Volume 7 Number 6 December 2016 ISSN 2141-2618
    Journal of Medical Laboratory and Diagnosis Volume 7 Number 6 December 2016 ISSN 2141-2618 ABOUT JMLD Journal of Medical Laboratory and Diagnosis (JMLD) is published monthly (one volume per year) by Academic Journals. Journal of Medical Laboratory and Diagnosis (JMLD) provides rapid publication (monthly) of articles in all areas of the subject such as Parasitism, Helminthology, Cloning vector, retroviral integration, Genetic markers etc. Contact Us Editorial Office: [email protected] Help Desk: [email protected] Website: http://www.academicjournals.org/journal/JMLD Submit manuscript online http://ms.academicjournals.me/ Editors Dr. Ratna Chakrabarti Dr. Rokkam Madhavi Department of Molecular Biology and Microbiology, Andhra University University of Central Florida, Visakhapatnam - 530003 Biomolecular Research Annex, Andhra Pradesh 12722 Research Parkway, India. Orlando, USA. Dr. Mukabana Wolfgang Richard School of Biological Sciences Dr. Rajni Kant University of Nairobi Scientist D (ADG), P.O. Box 30197 - 00100 GPO (P&I Division)Indian Council of Medical Research Nairobi, Post Box 4911, Ansari Nagar, Kenya. New Delhi-110029 India. Dr. Lachhman Das Singla College of Veterinary Science Dr. Ramasamy Harikrishnan Guru Angad Dev Veterinary and Animal Sciences Faculty of Marine Science, College of Ocean University Sciences Ludhiana-141004 Jeju National University Punjab Jeju city, Jeju 690 756 India. South Korea. Editorial Board Dr. Imna Issa Malele Dr. James Culvin Morris Tsetse & Trypanosomiasis Research Institute Clemson
    [Show full text]
  • Madridge Journal of Immunology
    ISSN: 2638-2024 Madridge Journal of Immunology Research Article Open Access Counterproductive contributions to African Epidemiology Helen Lauer1* and Joan Shenton2 1Professor, University of Dar es Salaam, Tanzania 2Director, Meditel Productions, UK Article Info Abstract *Corresponding author: Throughout this retrospective, our purpose is to illuminate an evident knowledge Helen Lauer handicap, cutting across the diagnostic procedures, reportage and mathematical Professor University of Dar es Salaam modelling of chronic illness affecting African public health demographics, which we Dar es Salaam trace to three epistemic injustices (methodological, documental, and professional) in Tanzania the way medical research in Africa is managed and monitored by foreigners. We E-mail: [email protected] propose that the mutual reinforcement of these three different kinds of epistemic transgression underlies the chronic failure of immunologists and public health Received: November 14, 2017 Accepted: November 17, 2017 practitioners to subdue the inflated rates of morbidity and short life expectancy Published: November 24, 2017 persistent throughout Africa. Substandard data collection and implausible infection modelling count as injustices because they are traceable to a routine disregard for best Citation: Lauer H, Shenton J. Counterproductive scientific practice at the upper echelons of global health authority, which is betrayed Madridge contributions to African Epidemiology. by an inordinately high tolerance for diagnostic error concerning populations
    [Show full text]
  • Parathormone Determination in the Clinical Laboratory: Biochemical, Analytical and Clinical Aspects
    UNIVERSITY OF LIEGE FACULTY OF MEDICINE DEPARTMENT OF CLINICAL CHEMISTRY Professor J.P. Chapelle PARATHORMONE DETERMINATION IN THE CLINICAL LABORATORY: BIOCHEMICAL, ANALYTICAL AND CLINICAL ASPECTS. Thesis submitted by Etienne CAVALIER for the degree of « Docteur en Sciences Biomédicales et Pharmaceutiques » Academic year 2009-2010 UNIVERSITY OF LIEGE FACULTY OF MEDICINE DEPARTMENT OF CLINICAL CHEMISTRY Professor J.P. Chapelle PARATHORMONE DETERMINATION IN THE CLINICAL LABORATORY: BIOCHEMICAL, ANALYTICAL AND CLINICAL ASPECTS. Thesis submitted by Etienne CAVALIER for the degree of « Docteur en Sciences Biomédicales et Pharmaceutiques » Academic year 2009-2010 1 University of Liege – Faculty of Medicine Department of Clinical Chemistry. Parathormone determination in the Clinical Laboratory: biochemical, analytical and clinical aspects. Abstract. The aim of our work was to provide comprehensive data to the study of the Parathyroid hormone (Parathormone, or PTH). The first part of the manuscript concerns the “laboratory” aspects of PTH determination. We thus studied the stability of the peptide when stored at different temperatures (pre-analytical phase). From an analytical point of view, we compared different methods for PTH determination and the impact of any change in PTH determination for the follow-up of the hemodialyzed patients. We also studied some analytical interferences and provided a validation strategy that takes into consideration these interferences. Finally, for the post-analytical phase, we established the reference range of PTH with two different methods. We provided guidelines which could help laboratories to establish their own reference range for PTH and studied the clinical impact of applying this newly established reference range in the daily routine. The second part of the manuscript is more dedicated to the “clinical” aspects of PTH determination.
    [Show full text]
  • Andreas Vesalius' Corpses
    Izvorni znanstveni ~lanak Acta med-hist Adriat 2014; 12(1);9-26 Original scientific paper UDK: 61:616.091’’16’’(091) ANDREAS VESALIUS’ CORPSES KADAVERI ANDRIJE VEZALA Maurits Biesbrouck*, Omer Steeno** Summary Judging from his writings, Andreas Vesalius must have had dozens of bodies at his disposal, thirteen of which were definitely from before 1543. They came from cemeteries, places of exe- cution or hospitals. Not only did his students help him obtain the bodies, but also public and judicial authorities. At first, he used the corpses for his own learning purposes, and later to teach his students and to write De humani corporis fabrica, his principal work. Clearly he had an eye for comparative anatomy. He observed anatomical variants and studied foetal anatomy. Occasionally, he would dissect a body to study physiological processes, while the post-mortems on the bodies brought in by the families of the deceased gave him an insight into human pathology. Some of his dissection reports have been preserved. Key words: History of medicine; 16th century; anatomy; pathology; corpses; Andreas Vesalius; Fabrica. To become the founder of modern anatomy, Andreas Vesalius (Brussels, 31 December 1514 - Zakynthos, 15 October 1564) must have had access to a large quantity of human remains in the broadest sense of the term. These constituted his source of data and his study material. At first, he used these remains to learn, and, when his knowledge reached an unprecedented level, * Former clinical biologist at the City Hospital in Roeselare, Belgium. ** Professor emeritus at the Faculty of Medicine of the Catholic University of Leuven (Louvain), Belgium.
    [Show full text]
  • Addressing Amr in Madagascar: the Experience of Establishing a Medical Bacteriology Laboratory at the Befelatanana University Hospital in Antananarivo
    IPC AND SURVEILLANCE ADDRESSING AMR IN MADAGASCAR: THE EXPERIENCE OF ESTABLISHING A MEDICAL BACTERIOLOGY LABORATORY AT THE BEFELATANANA UNIVERSITY HOSPITAL IN ANTANANARIVO DR SAÏDA RASOANANDRASANA (TOP LEFT), HEAD OF MICROBIOLOGY, BEFELATANANA UNIVERSITY HOSPITAL LABORATORY, MADAGASCAR; DR LALAINA RAHAJAMANANA (TOP MIDDLE-LEFT), HEAD, BACTERIOLOGY LABORATORY, TSARALALÀNA MOTHER-CHILD UNIVERSITY HOSPITAL, MADAGASCAR; DR CAMILLE BOUSSIOUX (TOP MIDDLE-RIGHT), HOSPITAL RESIDENT, MÉRIEUX FOUNDATION; DR MARION DUDEZ (TOP RIGHT), MEDICAL BIOLOGIST, FORMER RESIDENT, THE MÉRIEUX FOUNDATION IN MADAGASCAR; DR ODILE OUWE MISSI OUKEM-BOYER (BOTTOM LEFT), MÉRIEUX FOUNDATION MALI AND NIGER COUNTRY MANAGER, ACTING DIRECTOR GENERAL, CHARLES MÉRIEUX CENTER FOR INFECTIOUS DISEASE IN MALI; LUCIANA RAKOTOARISOA (BOTTOM MIDDLE-LEFT), MÉRIEUX FOUNDATION MADAGASCAR COUNTRY MANAGER; DR LAURENT RASKINE (BOTTOM MIDDLE-RIGHT), HEAD, SPECIALIZED BIOLOGY, MÉRIEUX FOUNDATION AND DR FRANÇOIS-XAVIER BABIN (BOTTOM RIGHT), DIRECTOR, DIAGNOSTICS AND HEALTH SYSTEMS, MÉRIEUX FOUNDATION In 2016, the Mérieux Foundation launched a project with the Ministry of Public Health to create a bacteriology laboratory at Befelatanana hospital in Antananarivo (Madagascar). The objective was to create and ensure the continued viability of operations for an essential package of analyses, to improve diagnosis and produce reliable data on antimicrobial resistance. The laboratory results have improved patient care and enabled antibiotic stewardship and hospital acquired infection control. Preliminary
    [Show full text]
  • Educational Workshop EW11: Development of Molecular Assays: Do's & Don't's Arranged with the ESCMID Study Group for Molecular Diagnostics (ESGMD)
    Educational Workshop EW11: Development of molecular assays: do's & don't's arranged with the ESCMID Study Group for Molecular Diagnostics (ESGMD) Convenors: Marijjyke Raymaekers ( Hasselt,,) BE) Paul Savelkoul (Amsterdam, NL) Faculty: Anton M. van Loon (Utrecht, NL) Kate Templeton (Edinburgh, UK) Marijke Raymaekers (Hasselt, BE) Udo Reischl (Regensburg, DE) Paul Savelkoul (Amsterdam, NL) Van Loon - QC controls Development of Molecular Assays: Do’s and Don’t’s QC controls Anton M van Loon Department of Virology, University Medical Centre Utrecht, the Netherlands QCMD, Glasgow Scotland 1 Anton M van Loon, ECCMID 2010 Molecular Diagnostics is hot! Scientific impact •The human genome project •Elucidation of new pathogenesis pathways •Discovery of new infectious agents Increased public awareness •Criminal investigations and court room cases (Castro –Ponce, Nienke K, etc.) • Fuelled by Film and TV industry (CSI, ‘Waking the Dead’, 6th Day, etc.) 2 Anton M van Loon, ECCMID 2010 DNA tells the truth General perception: DNA doesn’t lie –or does it? •Famous court cases, for example Castro –Ponce •Incorrect results on BCRA‐1/2 detection • Missed HIV diagnosis in neonate • Conflicting reports in literature, for instance on the etiology of chronic fatigue syndrome, ALS, schizophrenia, etc. So, maybe DNA does not lie, but it still requires human efforts to develop assays, to collect and investigate samples, and to interpret the results: need to monitor quality of the overall process! 3 Anton M van Loon, ECCMID 2010 3 Van Loon - QC controls Quality Concerns
    [Show full text]
  • Belgian Ebola Guidelines
    PUBLICATION OF THE SUPERIOR HEALTH COUNCIL No. 9188 Practical recommendations to the attention of healthcare professionals and health authorities regarding the identification of and care delivered to suspected or confirmed carriers of highly contagious viruses (of the Ebola or Marburg type) in the context of an epidemic outbreak in West Africa Recommandations pratiques concernant l’identification et la prise en charge de patients suspectés ou avérés être porteurs de virus hautement contagieux (de type Ebola ou Marburg) dans le cadre d’une bouffée épidémique en Afrique de l’Ouest, à l’attention des professionnels de la santé et des autorités sanitaires. Praktische aanbevelingen ter attentie van gezondheidswerkers en gezondheidsautoriteiten betreffende de identificatie en het beheer van vermoede of bevestigde dragers van zeer besmettelijke virussen (van het Ebola- of Marburg-type) in het kader van een uitbraak in West-Afrika. 4 July 2014 SUMMARY This document provides guidance on the management of patients in whom an infection with Ebola or Marburg disease (EMD) is considered, suspected or confirmed. This guidance aims to eliminate or minimize the risk of transmission to healthcare workers and others coming into contact with an infected patient or their samples. VHFs (Viral haemorrhagic fever) are severe and life-threatening viral diseases that have been reported in parts of Africa. VHFs are of particular public health importance because they can spread within a hospital setting; they have a high case-fatality rate; they are difficult to recognize and detect rapidly; and there is no effective treatment. Evidence from outbreaks strongly indicates that the main routes of transmission of EMD infection are direct contact (through broken skin or mucous membrane) with blood or body fluids, and indirect contact with environments contaminated with splashes or droplets of blood or body fluids.
    [Show full text]
  • Assessment of Antimicrobial Susceptibility Testing Techniques in Some Laboratories in Cameroon
    Vol. 7(6), pp. 36-41, December 2016 DOI: 10.5897/JMLD2016.0135 Article Number: 6027A5161907 Journal of Medical Laboratory ISSN 2141-2618 Copyright © 2016 and Diagnosis Author(s) retain the copyright of this article http://www.academicjournals.org/JMLD Full Length Research Paper Assessment of antimicrobial susceptibility testing techniques in some laboratories in Cameroon Tchoula Mamiafo Corinne1*, Gonsu Kamga Hortense 2,3, Toukam Michel2, Emilia Enjema Lyonga-Mbamyah2, Andremont Antoine4. 1Department of Microbiology, School of Health Sciences, Catholic University of Central Africa, Yaoundé, Cameroon. 2Department of Microbiology, Haematology, Parasitology and Infectious Diseases, Faculty of Medicine and Biomedical Sciences, University of Yaounde I, Yaounde, Cameroon. 3Bacteriology Laboratory, Yaoundé University Teaching Hospital, Yaoundé, Cameroon. 4Department of Microbiology, Paris-Diderot Faculty of medicine, Paris, France. Received 25 September, 2016: Accepted 24 November, 2016 The increasing bacterial resistance to antimicrobial agents has rendered susceptibility testing an indispensable tool for appropriate antibiotic selection. This study is aimed at evaluating the technical methods of antibiogram in some medical laboratories in Cameroon. A descriptive cross-sectional study was carried out. The data collection was done with two material, the questionnaire and the observation sheet. We enrolled 13 laboratories trough a non-probabilistic technic (Quota sampling). Quality control of media and antibiotic discs as well as their conservation did not comply with the standards. Over 76.9% of laboratories did not have the Mac Farland standard range. One hundred percent of the laboratories used the 90 mm diameter petri dishes. Five to fourteen discs were deposit with a mean of 08 discs per Petri dish. The reading of inhibition zones was done by visual estimation in 56.8% of the laboratories.
    [Show full text]
  • Discovery Consists of Seeing What Everybody Has Seen, And
    Discovery consists of seeing “ “ what everybody has seen, and thinking what nobody has thought. Albert SZENT-GYORGYI, 1937 Nobel Prize for Medicine 1 ADMINISTRATIVE STRUCTURE The administrative structure of the Institute is composed of an Institute Administrative Coordinator, a Clinical Research Unit and the Logistics and Accounts Unit. This structure ensures a transversal support to all Research Groups. Institutes Administrative Coordinator (CAI): Michel Van Hassel Clinical Research Unit: Regulatory Affairs, Quality, Contract-Budget Analysis of Clinical Trials Clémentine Janssens Valérie Buchet Salvatore Livolsi Marie Masson Dominique Van Ophem Logistics and Accounts Unit: Maimouna Elmjouzi MBLG/CTMA Myriam Goosse-Roblain MIRO Eric Legrand CHEX Cyril Mougin FATH/RUMA Michel Notteghem CARD/EDIN Dora Ourives Sereno GYNE/PEDI/GAEN Nadtha Panin LTAP IREC General Address: Avenue Hippocrate, 55 bte B1.55.02 1200 Woluwe-Saint-Lambert Internet Address: http://www.uclouvain.be/irec.html 2 The Institute brings together different research groups who work to improve our understanding of disease mechanisms, as well as to discover and/or develop new therapeutic strategies. Basic research joins clinical research in an enriching environment where clinical scientists and basic researchers can exchange their experiences and work on common projects. Our focus is thus clearly on translational research. Research at our Institute covers a wide range of biomedical problems and is mostly organized in an organ or system specific manner. The Institute is composed of 21 research groups working in close collaboration with the Cliniques universitaires Saint- Luc, in Brussels, and Mont-Godinne, in Yvoir. The Institute brings together more than 500 researchers and PhD students of different horizons and provides logistical support for both basic and clinical research.
    [Show full text]
  • PRO-SERO-COV Study
    ANTIBODY RESPONSE TO THE SARS-COV-2 VIRUS IN STAFF WORKING AT INSTITUT BERGONIÉ IN THE CONTEXT OF THE COVID-19 PANDEMIC PRO-SERO-COV study NCT04426006 Interventional research protocol involving people Category 2 for minimal risks and obligations ID-RCB no. 2020-A01355-34 / IB no.: 2020-01 Version no. 2.0 of 25/09/2020 Principal investigator: Dr Brice RICHEZ Department of Anaesthesia and Intensive Care Anaesthetist Institut Bergonié 229, cours de l’Argonne – 33076 BORDEAUX Cedex Phone: +33 (0)556 333 217 – Fax: +33 (0)556 333 330 E-mail: [email protected] Scientific managers Dr Francoise DURRIEU Department of Biopathology, Institut Bergonié Doctor, clinical biologist Prof. Simone MATHOULIN‐PELISSIER UREC, Institut Bergonié Head doctor of the Research and Clinical Epidemiology Unit (UREC) Dr Isabelle SOUBEYRAN Department of Biopathology, Institut Bergonié Pathology specialist Prof. Isabelle BALDI Occupational doctor INSERM U1219/EPICENE team, Université Bordeaux Research and Clinical Epidemiology Unit Carine BELLERA Institut Bergonié Biostatistician Carine LALET Institut Bergonié Head of Clinical Studies SPONSOR INSTITUT BERGONIÉ Version 2.0 of 25/09/2020 Page 1 of 9 Institut Bergonié PRO-SERO-COV summary SUMMARY Antibody response to the SARS-CoV-2 virus in staff working at Institut TITLE OF THE STUDY Bergonié in the context of the COVID-19 pandemic. ACRONYM PRO-SERO-COV SPONSOR Institut Bergonié, Bordeaux RIPH2 (category 2 interventional research protocol involving people: minimal STUDY CATEGORY risks and obligations) COORDINATING/PRINCIPAL Dr Brice RICHEZ, Institut Bergonié INVESTIGATOR Dr Françoise DURRIEU, Institut Bergonié Prof. Simone MATHOULIN‐PELISSIER, Institut Bergonié SCIENTIFIC MANAGERS Dr Isabelle SOUBEYRAN, Institut Bergonié Prof.
    [Show full text]