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Clinical Laboratory Preparedness and Response Guide (Blue Book)

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Clinical Laboratory Preparedness and Response Guide (Blue Book) TABLE OF CONTENTS Table of Contents ...................................................................................................................................................................................... 2 State Information ....................................................................................................................................................................................... 7 Introduction .............................................................................................................................................................................................. 10 Laboratory Response Network (LRN) .......................................................................................................................................... 15 Other Emergency Preparedness Response Information: .................................................................................................... 19 Radiological Threats ......................................................................................................................................................................... 21 Food Safety Threats .......................................................................................................................................................................... 25 BioWatch Program ............................................................................................................................................................................ 27 Bio Detection Systems – BDS......................................................................................................................................................... 28 Biosafety Basics ....................................................................................................................................................................................... 31 Biosafety Defined ............................................................................................................................................................................... 31 Biosafety Levels .................................................................................................................................................................................. 31 Laboratory Exposures and Lab Acquired Infections (LAIs) ................................................................................................. 34 Aerosol and Droplet Production .................................................................................................................................................. 35 BSL-3 Practices and When to Use BSL-3 Practices in a BSL-2 Laboratory ...................................................................... 37 Biological Risk Assessment.................................................................................................................................................................. 42 Risk Assessment: a 5-step Process Involving Hazard Identification and Hazard Control ........................................ 44 Biosecurity Basics .................................................................................................................................................................................... 46 Biosecurity Defined ........................................................................................................................................................................... 46 Biosecurity and Select Agents ....................................................................................................................................................... 46 Risk Management .............................................................................................................................................................................. 47 Example Guidance: A Biosecurity Risk Assessment and Management Process .......................................................... 47 Chain-of-Custody Guidance for Clinical Laboratories ............................................................................................................... 54 Regulations That Impact Clinical Laboratories ............................................................................................................................ 56 Select Agent Regulations ................................................................................................................................................................ 56 APHIS/CDC Forms .............................................................................................................................................................................. 56 What to do if you Suspect or Have a Confirmed Identification of a Select Agent ...................................................... 57 OSHA Bloodborne Pathogens Regulations .............................................................................................................................. 57 Clinical Laboratory improvement Act (CLIA) ........................................................................................................................... 61 Agents ......................................................................................................................................................................................................... 62 2 Quick Reference Guide to Specimen Collection of Suspected Agents of Bioterrorism & Emerging Infectious Diseases ................................................................................................................................................................................................. 63 Quick Reference Guide to Specimen Collection of Unknown Virus ................................................................................ 69 Quick Reference Guide to Specimen Collection for Botulism ........................................................................................... 71 Quick Reference Guide to Specimen Collection for Staphylococcal Enterotoxin B .................................................. 73 Bacillus anthracis (ANTHRAX) ........................................................................................................................................................ 75 Bacillus anthracis Identification Flowchart................................................................................................................................ 82 Brucella spp. (B. abortus, B. canis, B. melitensis, and B. suis) (BRUCELLOSIS) ................................................................... 85 Brucella Identification Flowchart ................................................................................................................................................ 102 Burkholderia mallei (GLANDERS) ................................................................................................................................................. 108 Burkholderia mallei Identification Flowchart.......................................................................................................................... 115 Burkholderia pseudomallei (MELIOIDOSIS) .............................................................................................................................. 118 Burkholderia pseudomallei Identification Flowchart............................................................................................................ 126 Francisella tularensis (TULAREMIA) ............................................................................................................................................ 129 Francisella tularensis Identification Flowchart ....................................................................................................................... 137 Yersinia pestis (PLAGUE) ................................................................................................................................................................. 140 Yersinia pestis Identification Flowchart .................................................................................................................................... 152 AlphaViruses ...................................................................................................................................................................................... 156 Botulinum Toxin (BoNT) Clostridium botulinum .................................................................................................................... 160 Coxiella burnetii (Q FEVER) ............................................................................................................................................................ 164 Orthopox viruses (SMALLPOX) ................................................................................................................................................... 169 Ricinus communis (RICININE) ........................................................................................................................................................ 173 Staphylococcal Enterotoxin B (SEB) Staphylococcus aureus ............................................................................................. 177 Viral Hemorrhagic Fevers (VHF) .................................................................................................................................................. 180 Packaging and Shipping ...................................................................................................................................................................
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