CHAPTER 8 INVESTIGATIONS OPERATIONS MANUAL 2017

CHAPTER 8 - INVESTIGATIONS CONTENTS

SUBCHAPTER 8.1 - INVESTIGATIONS ................................405 SUBCHAPTER 8.2 - COMPLAINTS .......................................405 8.2.1 - COMPLAINT CATEGORIES .......................................406 8.2.1.1 - Injury/Illness Complaints ...........................................406 8.2.1.2 - Non-Injury/Illness Complaints ...................................406 8.2.2 - INFANT FORMULA AND BABY FOOD .......................406 8.2.3 - COMPLAINTS INVOLVING ALCOHOLIC BEVERAGES

..........................................................................407 8.2.4 - OFFICE OF EMERGENCY OPERATIONS GUIDANCE

..........................................................................407 8.2.5 - INTERVIEWS ..............................................................407 8.2.5.1 - Basic Information to Obtain ...................................407 8.2.5.2 - Injury/Illness Complaints .......................................407 8.2.5.3 - Additional Information to Obtain ...........................407 8.2.5.4 Complainant Access to Report/ Results ..............407 8.2.6 - MEDICAL RECORDS ..................................................407 8.2.7 - SAMPLE COLLECTION ..............................................408 8.2.8 - RECORDING COMPLAINTS/FOLLOW-UPS ..............409 SUBCHAPTER 8.3 - INVESTIGATION OF FOODBORNE

OUTBREAKS ....................................................409 8.3.1 - FOODBORNE OUTBREAKS .......................................409 8.3.1.1 - Outbreaks on Foreign Flag Vessels..........................409 8.3.1.2 - Outbreaks Involving Interstate Conveyances............409 8.3.1.3 - Cooperation with Other Agencies .............................409 8.3.1.4 Farm Investigations...................................................410 8.3.1.4.1 Approach................................................................. 410 8.3.1.4.2 Sampling ................................................................. 410 8.3.1.4.3 Form 3623 Farm Investigation Questionnaire .........411 8.3.1.4.4 Recording 483 Observations...................................411 8.3.1.4.5 Reporting ................................................................411 8.3.2 - FOLLOW-UP GUIDANCE............................................411 8.3.2.1 - Preparation ..............................................................411 8.3.2.2 - Interviews ................................................................411 8.3.2.2.1 - CONTACTING THE COMPLAINANT ...................411 8.3.2.2.2 - SETTING COMMUNICATION LEVEL...................411 8.3.2.2.3 - INFORMATION TO GATHER ...............................412 8.3.2.3 - Medical Records .....................................................412 8.3.3 - SAMPLING PROCEDURES ........................................412 8.3.3.1 - Sample Collection .....................................................412 8.3.3.2 - Sample Size..............................................................412 8.3.3.3 - Sample Handling.......................................................412 8.3.4 - EPIDEMIOLOGICAL ASSOCIATIONS ........................413 8.3.4.1 - Outbreak Determination ............................................413 8.3.4.2 - Assistance ................................................................413 8.3.4.3 - Additional Case History Interviews............................413 8.3.4.4 - Establishment Investigation ......................................414 8.3.4.5 - Food Handlers Interviews .........................................414 8.3.4.6 - Possible Contamination Source ................................414 8.3.4.6.1 - PESTS ...................................................................414 8.3.4.6.2 - RAW MEAT ...........................................................415 8.3.4.6.3 - POOR SANITATION ..............................................415 8.3.4.6.4 - WORKERS ............................................................415 8.3.4.7 - Pathogen Growth Factors .........................................415 8.3.5 - ANALYZING DATA/HYPOTHESIS FORMULATION ...415 8.3.5.1 - Epidemic Curve.........................................................415 8.3.5.2 - Symptoms Determination..........................................415 8.3.5.3 - Incubation Periods ....................................................416 8.3.5.4 - Attack Rate Table .....................................................416 8.3.5.5 - Tracebacks of Foods Implicated in Foodborne

Outbreaks ..........................................................416 8.3.6 - REPORTING ...............................................................416 8.3.7 - REFERENCES ............................................................417 SUBCHAPTER 8.4 - INVESTIGATION - INJURY & ADVERSE

REACTION ........................................................417 8.4.1 - INVESTIGATIONS .......................................................417 8.4.1.1 - Procedures ...............................................................417

8.4.2 - DRUGS - INJURY OR REACTIONS ............................418

8.4.2.1 - Investigative Procedures ...........................................418 8.4.3 - DEVICES - INJURY .....................................................418 8.4.3.1 - Mechanical, Electrical or Electromechanical Devices418 8.4.3.2 - Devices for Implant....................................................418 8.4.3.3 - In Vitro Diagnostic Devices .......................................418 8.4.3.4 - Investigative Procedures ...........................................419 8.4.3.4.1 - DEVICES ...............................................................419 8.4.3.4.2 - IN VITRO DIAGNOSTICS ......................................419 8.4.3.4.3 - DIALYSIS INJURY OR DEATHS ...........................419 8.4.4 - BIOLOGICS - INJURY, REACTION OR FATALITY .....420 8.4.4.1 - Professional Reporting System for Vaccine Adverse

Reactions ...........................................................420 8.4.4.2 - Investigation/Reporting..............................................420 8.4.5 - FOODS, DIETARY SUPPLEMENTS AND COSMETICS -

INJURY OR REACTION ....................................421 8.4.5.1 - Cosmetics .................................................................421 8.4.5.2 - Dietary Supplements .................................................421 8.4.5.2.1 - CAUSES ................................................................422 8.4.5.2.2 - PROCEDURES ......................................................422 8.4.5.3 - Investigation Requirements for Serious Adverse Events

of CFSAN Regulated Products ..........................422 8.4.5.4 - Undeclared Allergen/Allergic Reactions ....................422 8.4.6 - VETERINARY PRODUCTS - COMPLAINTS/ADVERSE

REACTIONS ......................................................423 8.4.7 - SAMPLE COLLECTION ...............................................423 8.4.7.1 - Device Samples ........................................................423 8.4.7.2 - Biological Samples ....................................................423 8.4.7.3 - Cosmetic Samples ....................................................423 8.4.7.4 - Microbiological Contamination ..................................423 8.4.7.5 - Allergen Samples ......................................................423 8.4.7.6 - Tobacco Products Samples ......................................424 8.4.8 - REPORTING ................................................................424 8.4.8.1 - Reporting Forms........................................................424 8.4.8.2 - Routing Reports ........................................................424 8.4.8.2.1 - DRUGS ..................................................................424 8.4.8.2.2 - MEDICAL DEVICE AND RADIOLOGICAL

PRODUCTS .......................................................424 8.4.8.2.3 - FOODS AND COSMETICS ....................................424 8.4.8.2.4 - VETERINARY PRODUCTS ...................................425 8.4.8.2.5 - LICENSED BIOLOGICAL PRODUCTS..................425 8.4.8.2.6 - UNLICENSED BIOLOGICAL PRODUCTS ............425 8.4.8.2.7 - BIOLOGICS INJURY/ADVERSE REACTION

REPORTS..........................................................425 8.4.8.2.8 TOBACCO PRODUCTS INJURY/ADVERSE

REACTION REPORTS ......................................425 SUBCHAPTER 8.5 - DISASTER PROCEDURES...................425 8.5.1 - DISASTER TYPES.......................................................425 8.5.2 - RESPONSIBILITY & COORDINATION........................425 8.5.3 - PREPARATION............................................................426 8.5.4 - PRELIMINARY INVESTIGATION ................................426 8.5.5 - FIELD OPERATIONS...................................................426 8.5.5.1 - Embargoes ................................................................426 8.5.5.2 - Field Examination & Samples ...................................427 8.5.5.3 - Flooding ....................................................................427 8.5.5.4 - Hurricanes & Tornadoes ...........................................428 8.5.5.5 - Fires, Explosions, Riots .............................................428 8.5.5.6 - Chemical Spills, Hazardous Waste Sites, Wrecks.....428 8.5.5.7 - Earthquakes ..............................................................428 8.5.6 - BIOTERRORISM..........................................................428 8.5.7 - PRODUCT DISPOSITION ...........................................429 8.5.7.1 - Segregation ...............................................................429 8.5.7.2 - Destruction ................................................................429 8.5.7.3 - Reconditioning...........................................................429 8.5.7.4 - Relabeling ......................................