Laboratory Assessment of Antibiotic Resistance Testing Capacity User’s Guide and Questionnaire VERSION 2.0 AUGUST 2020 Division of Healthcare Quality Promotion CS320242-A LAARC User’s Guide and Questionnaire Version 2.0 August 2020 The Laboratory Assessment of Antibiotic Resistance Testing Capacity is a publication of the Division of Healthcare Quality Promotion in the National Center for Emerging and Zoonotic Infectious Diseases within the U.S. Centers for Disease Control and Prevention (CDC). U.S. Centers for Disease Control and Prevention Robert Redfield, MD, Director National Center for Emerging and Zoonotic Infectious Diseases Rima Khabbaz, MD, Director Division of Healthcare Quality Promotion Denise Cardo, MD, Director Photo Credit: Daniella Coker Cover page photo features (l-r) Dr. Hein Bui of CDC, Vietnam; Mr. Truong Nguyen, a healthcare informatics consultant in Vietnam; and Dr. Mai Van Tuan, a clinical microbiologist in Hue, Vietnam. They are examining a lidded and sealed non-infectious petri dish in an anteroom of a non-CDC laboratory in Vietnam. Suggested citation: Centers for Disease Control and Prevention. Laboratory Assessment of Antibiotic Resistance Testing Capacity. Atlanta, GA: U.S. Department of Health and Human Services, CDC; 2020. Available at: https://www.cdc.gov/drugresistance/intl-activities/laarc.html. Version 2 | August 2020 Page 1 of 90 LAARC User’s Guide and Questionnaire ACKNOWLEDGEMENTS Susan Bollinger (International Infection Control Program, Division of Healthcare Quality Promotion, U.S. Centers for Disease Control and Prevention, Atlanta, Georgia, USA) led the overall development of the LAARC questionnaire and coordinated the piloting and revision of the tool in collaboration with internal and external stakeholders. She also provided expert subject matter input to the development of the Excel scoring tool. Sonya Arundar and Joyce Thomas (Division of Healthcare Quality Promotion, CDC) provided professional editing (plain language and usability) assistance. Antoine Pierson (Integrated Quality Laboratory Services, IQLS, Lyon, France) led the development of the Excel scoring tool and provided expert subject matter input on the LAARC content to optimize the use of the scoring tool. Additional support was provided by Abdoulaye Nikièma (IQLS). The following experts participated in technical consultations to guide the development and provided technical review of the tool: Rachel Smith, Ulzii Luvsansharav, Nora Chea, Michael Omondi, T.J. McKinney (Division of Healthcare Quality Promotion, CDC), Michele Parsons (Division of Global Health Protection, CDC). The following experts piloted the tool in resource-limited settings and provided technical expertise and feedback: Nino Macharashvili, Lan Nguyen, Hien Bui, Valan Siromany, Wangeci Gatei, Molly Freeman, Pawan Angra (Division of Global Health Protection, CDC). Lynee Galley, Emma Muir, Martin Evans, John TarBush, John Aldom, Abdul Chagla, Vlademir Cantarelli, Victor Silva, American Society for Microbiology (ASM); Mona ElShokry, Dana Itani, Walaa Khater, the World Health Organization (WHO); and Lindsey Shields, Rogers Kisame, Moctar Mouiche, (FHI360). Funding for the development of the Excel scoring tool was provided by the Division of Global Health Protection in the Center for Global Health through a Cooperative Agreement. DISCLAIMERS All rights reserved. Publication of the Centers for Disease Control and Prevention is available on the U.S. CDC website Lab Assessment of Antibiotic Resistance Testing Capacity (LAARC) (https://www.cdc.gov/drugresistance/intl-activities/laarc.html) or can be obtained from Centers for Disease Control and Prevention, 1600 Clifton Rd., Atlanta, GA, 30329, USA (email: [email protected]). The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the Centers for Disease Control and Prevention in preference to others of a similar nature who are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. The contents of the LAARC are solely the responsibility of the authors and do not necessarily represent the official views of the U.S. Centers for Disease Control and Prevention. All reasonable precautions have been taken to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and uses of the material lies with the reader. In no event shall the Centers for Disease Control and Prevention or IQLS be liable for damages arising from its use. Version 2 | August 2020 Page 2 of 90 LAARC User’s Guide and Questionnaire TABLE OF CONTENTS ACKNOWLEDGEMENTS ..............................................................................................................................................2 DISCLAIMERS ..............................................................................................................................................................2 TABLES AND FIGURES .................................................................................................................................................4 ACRONYMS .................................................................................................................................................................5 EXECUTIVE SUMMARY ................................................................................................................................................7 1. INTRODUCTION .................................................................................................................................................7 1.1. Rationale .................................................................................................................................................7 1.2. Purpose ...................................................................................................................................................7 1.3. Scope .......................................................................................................................................................8 2. ASSESSMENT PLANNING and PREPARATION ................................................................................................ 10 2.1. Assessment Team ................................................................................................................................ 10 2.2. Team Preparation ................................................................................................................................ 10 2.3. Laboratory Preparation ........................................................................................................................ 11 2.4. Assessment Process ............................................................................................................................. 11 2.4.1. Take GPS Location ...................................................................................................................... 11 2.4.2. Meet with staff ........................................................................................................................... 11 2.4.3. Tour the laboratory .................................................................................................................... 12 2.4.4. Review Documents and Fill the Questionnaire .......................................................................... 12 2.4.5. Professionalism .......................................................................................................................... 12 3. LAARC TOOL STRUCTURE ............................................................................................................................... 13 3.1. Files ...................................................................................................................................................... 13 3.2. Excel File Organization ......................................................................................................................... 13 3.2.1. Yellow: ....................................................................................................................................... 13 3.2.2. Blue: Questionnaire (15 tabs) .................................................................................................... 13 3.2.3. Questionnaire Organization and Structure ................................................................................ 14 3.2.4. Red: ........................................................................................................................................... 15 4. ENTERING DATA INTO THE EXCEL TOOL ........................................................................................................ 16 4.1. Generate a Unique Filename ............................................................................................................... 16 4.2. Select Language ................................................................................................................................... 16 4.3. Answer Questions ................................................................................................................................ 16 4.3.1. Drop-down boxes ....................................................................................................................... 16 4.3.2. Free-text cells and Comment cells ............................................................................................