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Safe Handling, Packaging & Shipping of Infectious Substances Utah Department of Health November 21, 2002 Kim Christensen Objectives Information on possible organisms Why these organisms? Safety Samples Packaging Transport/Shipping Agents of Highest Concern Bacillus anthracis (Anthrax) Francisella tularensis (Tularemia) Yersinia pestis (Plague) Botulinum toxin (Botulism) Variola major (Smallpox) Viral Hemorrhagic Fevers Other Possible Agents Brucella spp. – Brucellosis Coxiella burnetti – Q-fever Arboviruses (West Nile) – encephalitis Mycotoxins Ricin Toxin – Castor beans SEB – Staphylococcus Enterotoxin B Why these organisms? Can cause disease via aerosol route Fairly stable in aerosolized form Susceptible civilian population High morbidity and mortality rates Difficult to diagnose and/or treat Some can be transmitted person-to-person Bacillus anthracis Anthrax Bacillus anthracis – Gram-positive, spore-forming bacillus (rod) Bacillus anthracis Anthrax Cutaneous Exposure A skin lesion evolving during a period of 2-6 days from a papule, through a vesicular stage, to a depressed black eschar. Cutaneous Anthrax Intense itching Painless skin sore Incubation 1-5 days (up to 60) 20% fatality if untreated (may spread to blood) Direct contact with skin lesion may result in cutaneous infection Inhalation Anthrax Inhalation Anthrax A brief prodrome resembling a viral respiratory illness with radiograph evidence of mediastinal widening Inhalation Anthrax Flu-like symptoms – Fever, fatigue, muscle aches, difficulty breathing, headache, chest pain & non-productive cough 1-2 day improvement followed by respiratory failure, meningitis may develop No person-to-person spread Francisella tularensis Tularemia Humans become infected by: Handling infected animal carcasses “Rabbit Fever” Bites of ticks, deer flies, or mosquitoes No person-to-person transmission Endemic in Utah Tularemia Clinical Presentations Pneumonic Incubation 3-5 days Flu-like symptoms Mortality – 30% untreated <10% treated Ulceroglandular Ulcer w/adenopathy Glandular Adenopathy w/o lesion Oculoglandular Painful, purulent conjunctivitis Typhoidal Possible presentation for BT Septicemia Yersinia pestis Plague Transmission – Inhalation Direct contact Fleas Plague Clinical Presentations Bubonic Flu-like with painful buboes (lymph nodes) Septicemic Similar to bubonic No swelling of lymph nodes Plague Clinical Presentations Pneumonic Highest mortality Rapid transmission Fever Hemoptosis Lymphadenopathy Cough Plague Distribution Highest in 4 corners area – Western states Prairie dog population Botulism Clostridium botulinum Organism – gram positive, sporeforming, anaerobic bacilli Botulinum toxin Neurotoxin A, B, C1, D, E, F, G Botulism Foodborne Infant Constipation, poor-feeding, “failure to thrive”, weakness, impaired respiration and death Wound Diplopia (double vision), blurred vision, flaccid, symmetric paralysis (rapid progression) Same symptoms as foodborne w/infection through a wound Other Non-infant patient with no suspect food or wound Botulism Foodborne Most likely presentation for BT event Mortality Currently 5-10% Previously 60% Wound Mortality 15% Emerging problem of drug users Injecting Black Tar Heroin Variola major Smallpox Orthopox virus DNA virus Brick-shaped structure 200 nm in diameter Incubation 8-16 days Mortality 30% Clinical symptoms Acute Fever Headache Vomiting Backache Variola major Smallpox 4 Types 1. Ordinary – most frequent 2. Modified • Mild • Occurring in previously vaccinated persons 3. Flat 4. Hemorrhagic • Much shorter incubation • Not likely to be recognized as Smallpox (initially) Variola major Smallpox Disease Progression Incubation Period Initial Symptoms – Prodrome Rash Development & Distribution Variola minor Less common clinical presentation Much less severe disease Variola major Smallpox Rash Begins on face, hands, forearms & spreads to lower extremities within 7 days Lesions on palms & soles of feet Variola major Smallpox Rash Synchronous progression: maculesvesicles pustules scabs Smallpox Spread by infected droplets Most infectious after onset of rash Contagious until the last scab falls off Vaccine given within 4 days of exposure can prevent disease or lessen symptoms 70% recovery rate Chicken pox vs. Smallpox Viral Hemorrhagic Fevers Ebola Lassa Marburg Hanta Dengue Yellow fever Crimean-Congo Rift Valley fever Other Viral Hemorrhagic Fevers High Fever with: Mucous membrane bleeding Petechiae Malaise Muscle-aches Headaches May have diarrhea or vomiting Fatality depends on virus – 90% Ebola Viral Hemorrhagic Fevers Mosquito or tick vectors Person-to-person transmission through body fluids/blood Vaccine available for Yellow Fever People can be infected but show no signs or symptoms of disease Protection of First Responders & Health Care Workers Knowledge Universal Precautions Communication Vaccination Prophylaxis Safety First First Responders Personal Protective Equipment Established protocols Transporters Regulations Lab Personnel Personal Protective Equipment Established protocols Biosafety Containment Vaccinations Use Universal Precautions – treat everything as if it were contaminated Safety First Responders Know what you “might be” dealing with Protect yourself Protect the community Protect the next in line (transporter) Recommendations for the Selection and Use of Protective Clothing & Respirators Against Biological Agents: www.bt.cdc.gov/DocumentsApp/Anthrax/Protective/10242001Protect. asp Safety Transporter/Shipper Know what you “might be” dealing with Protect yourself Protect the public Follow rules and regulations IATA, USPS, DOT, Etc. Safety Laboratory Personnel Handle & process according to Biosafety Level Classifications (Level 1, Level 2, Level 3, Level 4) Biosafety in Microbiological & Biomedical Laboratories CDC/NIH, 4th Edition. Protect yourself Protect other laboratorians Protect the public Samples Clinical specimens Non-clinical Environmental Evidentiary Materials Clinical Specimen Selection All clinical specimens should go directly to a Level A Laboratory for processing Bacillus anthracis Anthrax Cutaneous Vesicular Stage Fluid from intact vesicles on sterile swab Eschar Stage Without removing eschar, rotate swab beneath edge of eschar & collect lesion material Gastrointestinal Stool 5-10 grams Sterile, leakproof container Rectal swab Blood Institution’s procedure Routine blood cultures Bacillus anthracis Anthrax Inhalational Sputum > 1 mL expectorated sputum Sterile, leakproof container Blood Institution’s procedure Routine blood cultures Yersinia pestis Plague Pneumonic Bronchial Wash/Transtracheal Aspirate > 1 ml Institution’s procedure Sputum/Throat Routine throat culture (swab) Expectorated sputum – sterile, leakproof container Septicemic Blood Institution’s procedure Routine blood culture Bubonic Biopsied Specimen Liver, spleen, bone marrow, lung Tissue aspirate May yield little material Francisella tularensis Tularemia Biopsied tissue Scraping of an ulcer - preferred Swab of an ulcer – alternate Tissue Aspirate Bronchial/Tracheal Wash Institution’s procedure Sputum/Throat Routine throat culture Sputum expectorated into sterile, leakproof container Blood Clostridium botulinum & Botulism Toxin Foodborne Clinical Material Autopsy Samples Serum Gastric contents Vomitus Stool Enema fluid Intestinal & Gastic contents Serum Food Samples Infant Stool Enema fluid Post-mortem samples (intestinal contents) Food samples Environmental Samples Clostridium botulinum & Botulism Toxin Wound Serum Wound tissue, exudate, swab Anaerobic transport Stool Enema fluid Isolate Bioterrorism – Intentional Release Serum Stool Enema fluid Gastric aspirate Nasal swab Food samples Environmental samples Variola major Smallpox Report immediately to UDOH UDOH contacts CDC & FBI Variola major Smallpox Biopsy Specimen 2-4 portions of tissue Sterile, leakproof, freezable container Scabs Scrapings/material Sterile, leakproof, freezable container Vesicular fluid Separate lesions Include cellular material Viral Hemorrhagic Fever Specific handling conditions are currently under development at the CDC. Serum 10-12cc of serum Chemical Exposure Specimens to be collected from each individual Urine At least 25 mL Screw-cap plastic containers Freeze ASAP Whole Blood Two – 5 or 7 mL purple-top (EDTA) tubes – vacuum-fill only (unopened) Whole Blood One 5 mL or 7 mL gray-top or green-top tube (unopened) One empty tube Whole Blood Two 10 mL red-top tubes no anticoagulant Do not separate serum from cells Non-Clinical Specimens To be delivered directly to the UDOH - Lab Animal Carcass, tissue, blood, bone, skin Vector Fleas, mosquitoes, ticks, flies Human Post-mortem specimens Environmental Samples To be delivered directly to the UDOH - Lab Water At least 500 mL Soil/Mud Plant Material Food Evidentiary Materials To be delivered directly to the UDOH - Lab Non-organics Organics Powder Paper Containers Hair Wood Liquids Example procedure for collecting environmental samples: www.bt.cdc.gov/Agent/Anthrax/environmentalsampling-apr2002.asp Chain of Custody Always observe a Chain of Custody Evidence CollectorTransporter Laboratory Each person to touch the sample must sign for it. Laboratory – Signed for each time the sample is manipulated Environmental Samples Please Pre-screen Sample should be determined to be a credible threat Determined by FBI/Local law enforcement Directly related to an event FBI or HAZMAT should pre-screen samples for: Bombs Incendiary Devices Radiological Materials Chemicals Specimen Packaging Clinical Containers: Sterile Leak-proof Blood collection tubes Sterile swabs Labeled, individually, with patient ID According to institution’s protocols Specimen Packaging Non-clinical Original containers – if possible 1. Sample placed in sealed, clean, dry container – Ziplock bags okay 2. Change gloves 3. Sample placed in 2nd container a. In a clean area b. Seal 2nd container 4. Change gloves 5. Decontaminate outer container with 10% bleach solution OR add a 3rd container. Packaging & Shipping Commercial Carriers & Local Transfer Regulations Protect! Postal personnel Airline personnel Industry personnel Made by: Federal government Private industry associations Regulations Responsibility is given to the SHIPPER! Shipper must CORRECTLY: Classify Package Label Prepare documentation For all Diagnostic & Infectious Materials MUST be Trained & Certified!!! Regulations Training & Certification Anyone directly involved with the shipping of diagnostic materials or infectious substances. 1 individual per institution must be trained. By certified training authority That person trains others Regulations Training & Certification Saf-T-Pak, Inc 1-day course – Spring 2003 – SLC 1-800-814-7484 www.saftpak.com Classification Diagnostic Specimen vs. Infectious Substance Diagnostic Specimen Not considered hazardous Poses negligible threat Low probability of containing pathogens Testing other than for presence of pathogens Have not been tested yet Classification Diagnostic Specimen vs. Infectious Substance Infectious Substance: Same as Hazardous Material Contains or Suspected to contain agent that may cause infection (bacteria/virus) Human/Animal samples likely to contain an infectious agent Shipment by Commercial Carrier Shipment by Commercial Carrier Planning Packaging Labeling Documenting Shipping Planning Call Recipient: Verify shipping address Obtain contact name & phone Verify when to ship Packaging Includes: Classification Packing Labeling Documentation Must withstand: Leakage Shocks Pressure Changes Other conditions Transport Packaging Primary Sample Container Waterproof & Leak-proof Seal plates/tubes with tape Wrap specimen container in absorbent material Enough to absorb entire liquid contents Ziplock Biohazard bag Solids – 1 bag Liquids – 2 bags Pre-freeze specimens if shipping frozen Packaging Secondary Container Complete Packaging System Unbreakable Water-proof Leak-proof Biohazard Label Commercial Suppliers of Certified Packaging Systems i.e. Saf-T-Pak, EXAKT-PAK Packaging Certified Outer Shipping Package Strong enough to hold capacity & mass Indicated on the bottom of box Choose appropriate package Must meet UN Class 6.2 Specs Must bear the UN Packaging Specification Marking 4G CLASS 6.2 / 99 U N CAN / 8-2 SAF-T-PAK Packaging Certified Outer Shipping Package Each comes with: Inner Packaging Labels Do NOT make any substitutions UN-certification becomes invalid Refurbishment kits may be used Packaging Certified Outer Shipping Package Closing instructions included Over-packs? Shipping packs & over-packs • Marked & Labeled identically • Additional Label: “Inner packages comply with prescribed specifications” Labeling Apply to flat surface w/o overlap or corner wrap HAZARD Labels for Dangerous Goods Must be displayed on packages containing: Infectious substances Dry ice Labeling Hazard Class 6.2 Infectious Substances Etiologic agents Biomedical material In case of damage or leakage Notify Director CDC, Atlanta, Georgia (404) 633-5313 Apply on the blank diamond marked on outside package Labeling Miscellaneous Hazard Class 9 Dry Ice Weight of dry ice in kg Handwritten on label Apply on side opposite Hazardous Substance label UN Shipping Name Label for Dry Ice Carbon dioxide, solid (Dry Ice) UN1845 _______kg Next to Dry Ice Hazard Label Labeling Orientation Labels Opposite sides of shipping container Do not cover the hazard labels UN Shipping Name Label Required for EACH Infectious Organism Infectious substances, Affecting humans (Escherichia coli) UN2814 X _________mL Apply next to Hazard Class 6.2 label Labeling Address Label One side of outer box Must include: Receiver’s name, shipping address (No PO boxes) & phone (with area code) Shipper’s name, address & phone Temperature/Storage requirements (optional) Documenting Complete forms & letters (enclose w/sample) Memo All infectious substance shipments Letterhead Insert on top of 2nd container Test request Documenting Shipping Record File Copies of all forms Keep 2 years Shipping Documents Provided by Commercial Carrier Documenting Shipping Documents Commercial Air Shipments require: Air Waybill • Name & telephone # responsible person • Person should be – Knowledgeable – Accessible 24/7 • Shipping pouch (address window) – Top surface of closed package Documenting Shipping Documents All infectious substance shipments require: Dangerous Goods Declaration To avoid a LARGE fine (> $1000) • Forms in shipping pouch & apply pouch to bottom of package • Edges of pouch cannot overlap any of the labels or markings on the side Shipping Some commercial carriers will NOT ship Call local carrier to see FedEx – will ship Computer program – document preparation Local Transport of Diagnostic Specimens & Infectious Substances Local Transport Usually courier service Transfer of specimens from: Dr.’s office/hospital Laboratory Laboratory Laboratory As important as air transport No possibility of contents escaping under normal transport conditions Packaging Primary Sample Container Water-proof Leak-proof Seal plates/tubes with tape Wrap absorbent material around specimen container and secure Ziplock Biohazard bag Solids – 1 bag Liquids – 2 bags Labeling Label with: Name, address & phone of recipient Storage requirements ID form/test request Outside pocket of biohazard bag Do NOT put forms inside with the specimen!! Transporting Sample containers placed in leak-proof, unbreakable Transport Box Secure, tight-fitting cover Biohazard label Frozen specimens Labeled, insulated box w/dry ice Transporting Transport box Carried to courier vehicle Secure in position for transport VERY IMPORTANT!! Courier Vehicle Should carry a spill kit with: Absorbent material Disposable gloves Chlorine disinfectant Leak-proof waste disposal container Regulations Public Health Service 42 CFR Part 72. Interstate Transportation of Etiologic Agents. http://www.cdc.gov/od/ohs/biosfty/shipregs.htm Department of Transportation. 49 DFR Parts 171-180. Hazardous Materials Regulations. Applies to the shipment of both biological agents and clinical specimens. http://www.hazmat.dot.gov/rules.htm New regulations just established Regulations United States Postal Service. 39 CFR Part 111. Mail ability of Etiologic Agents. From the Domestic Mail Manual 124.38 http://www.access.gpo.gov Occupational Health and Safety Administration (OSHA). 29 CFR Part 1910. 1030. Provides minimal packaging and labeling requirements for transport of blood and body fluids within the laboratory and outside of it. http://www.osha.gov Regulations Dangerous Goods Regulations (DGR). International Air Transport Association (IATA). These regulations followed by the airlines provide packaging and labeling requirements for infectious substances and materials as well as for diagnostic specimens. http://www.iata.org/cargo/dg/ Guidelines for the Safe Transport of Infectious Substances and Diagnostic Specimens. World Health Organization (WHO), 1997. http://www.who.int/emc/biosafety.html Other Websites CDC – Centers for Disease Control www.bt.cdc.gov ASM – American Society for Microbiology www.asmusa.org Utah Department of Health (Microbiology) www.health.utah.gov/els/microbiology Additional Comments Call ahead of time Clinical Specimens Go to Level A Labs for rule-out Environmental Specimens Clinical/Environmental Let lab know sample is on its way Go to UDOH Lab UDOH has 24/7 coverage Contact Information Utah Department of Health Lab Response Kim Christensen – 801-584-8449 [email protected] June Pounder – 801-584-8449 [email protected] Barbara Jepson – 801-884-8595 [email protected] Emergency Pager – 801-241-1172 FBI - 801-579-1400