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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

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safe handling packaging shipping of infectious substances

Safe Handling, Packaging & Shipping of Infectious Substances

Utah Department of Health

November 21, 2002

Kim Christensen

objectives
Objectives
  • Information on possible organisms
  • Why these organisms?
  • Safety
  • Samples
  • Packaging
  • Transport/Shipping
agents of highest concern
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
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
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 anthracisAnthrax
  • Bacillus anthracis –
    • Gram-positive, spore-forming bacillus (rod)
bacillus anthracis anthrax8
Bacillus anthracisAnthrax
  • 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
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
  • Inhalation Anthrax-
    • A brief prodrome resembling a viral respiratory illness with radiograph evidence of mediastinal widening
inhalation anthrax11
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
Francisella tularensisTularemia
  • 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

TularemiaClinical Presentations
yersinia pestis plague
Yersinia pestisPlague
  • 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

PlagueClinical Presentations
plague clinical presentations16
Pneumonic

Highest mortality

Rapid transmission

Fever

Hemoptosis

Lymphadenopathy

Cough

PlagueClinical Presentations
plague
Plague
  • Distribution
    • Highest in 4 corners area – Western states
    • Prairie dog population
botulism
Clostridium botulinum

Organism – gram positive, spore-forming, anaerobic bacilli

Botulinum toxin

Neurotoxin

A, B, C1, D, E, F, G

Botulism
botulism19
Botulism
  • Foodborne
    • Diplopia (double vision), blurred vision, flaccid, symmetric paralysis (rapid progression)
  • Infant
    • Constipation, poor-feeding, “failure to thrive”, weakness, impaired respiration and death
  • Wound
    • Same symptoms as foodborne w/infection through a wound
  • Other
    • Non-infant patient with no suspect food or wound
botulism20
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 majorSmallpox
variola major smallpox22
Variola majorSmallpox
  • 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 smallpox23
Variola majorSmallpox
  • Disease Progression
    • Incubation Period
    • Initial Symptoms – Prodrome
    • Rash Development & Distribution
  • Variola minor
    • Less common clinical presentation
    • Much less severe disease
variola major smallpox24
Rash

Begins on face, hands, forearms & spreads to lower extremities within 7 days

Lesions on palms & soles of feet

Variola majorSmallpox
variola major smallpox25
Rash

Synchronous progression: maculesvesicles pustules scabs

Variola majorSmallpox
smallpox
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
viral hemorrhagic fevers28
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 fevers29
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
Protection of First Responders & Health Care Workers
  • Knowledge
  • Universal Precautions
  • Communication
  • Vaccination
  • Prophylaxis
safety first
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
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
safety33
Safety
  • Transporter/Shipper
    • Know what you “might be” dealing with
    • Protect yourself
    • Protect the public
    • Follow rules and regulations
      • IATA, USPS, DOT, Etc.
safety34
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
Samples
  • Clinical specimens
  • Non-clinical
  • Environmental
  • Evidentiary Materials
slide36
Clinical Specimen SelectionAll clinical specimens should go directly to a Level A Laboratory for processing
bacillus anthracis anthrax37
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 anthracisAnthrax
bacillus anthracis anthrax38
Bacillus anthracisAnthrax
  • Inhalational
    • Sputum
      • > 1 mL expectorated sputum
      • Sterile, leakproof container
    • Blood
      • Institution’s procedure
      • Routine blood cultures
yersinia pestis plague39
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

Yersinia pestisPlague
francisella tularensis tularemia40
Francisella tularensisTularemia
  • 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

Serum

Gastric contents

Vomitus

Stool

Enema fluid

Autopsy Samples

Intestinal & Gastic contents

Serum

Food Samples

Infant

Stool

Enema fluid

Post-mortem samples (intestinal contents)

Food samples

Environmental Samples

Clostridium botulinum & Botulism Toxin
clostridium botulinum botulism toxin42
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

Clostridium botulinum & Botulism Toxin
variola major smallpox43
Variola majorSmallpox
  • Report immediately to UDOH
  • UDOH contacts CDC & FBI
variola major smallpox44
Variola majorSmallpox
  • 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
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

Chemical ExposureSpecimens to be collected from each individual
non clinical specimens to be delivered directly to the udoh lab
Non-Clinical SpecimensTo 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
Environmental SamplesTo 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
Evidentiary MaterialsTo be delivered directly to the UDOH - Lab
  • Non-organics
    • Powder
    • Paper
    • Containers
  • Organics
    • Hair
    • Wood
    • Liquids
  • Example procedure for collecting environmental samples:
    • www.bt.cdc.gov/Agent/Anthrax/environmental-sampling-apr2002.asp
chain of custody
Chain of Custody
  • Always observe a Chain of Custody
  • Evidence
  • CollectorTransporter 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

Environmental SamplesPlease Pre-screen
specimen packaging
Specimen Packaging
  • Clinical-
    • Containers:
      • Sterile
      • Leak-proof
      • Blood collection tubes
      • Sterile swabs
    • Labeled, individually, with patient ID
    • According to institution’s protocols
specimen packaging53
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

Packaging & Shipping

Commercial Carriers

&

Local Transfer

regulations
Regulations
  • Protect!
    • Postal personnel
    • Airline personnel
    • Industry personnel
  • Made by:
    • Federal government
    • Private industry associations
regulations56
Regulations
  • Responsibility is given to the SHIPPER!
    • Shipper must CORRECTLY:
      • Classify
      • Package
      • Label
      • Prepare documentation
      • For all Diagnostic & Infectious Materials
      • MUST be Trained & Certified!!!
regulations57
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
regulations58
Regulations
  • Training & Certification
    • Saf-T-Pak, Inc
      • 1-day course – Spring 2003 – SLC
      • 1-800-814-7484
      • www.saftpak.com
classification
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
classification60
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 carrier62
Shipment byCommercial Carrier
  • Planning
  • Packaging
  • Labeling
  • Documenting
  • Shipping
planning
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
packaging66
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
packaging67
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
packaging68
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

CAN / 8-2 SAF-T-PAK

U

N

packaging69
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
packaging70
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
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
labeling72
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

labeling73
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

labeling74
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

labeling75
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
Documenting
  • Complete forms & letters (enclose w/sample)
    • Memo
      • All infectious substance shipments
      • Letterhead
      • Insert on top of 2nd container
    • Test request
documenting77
Documenting
  • Shipping Record File
    • Copies of all forms
    • Keep 2 years
  • Shipping Documents
    • Provided by Commercial Carrier
documenting78
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
documenting79
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
Shipping
  • Some commercial carriers will NOT ship
    • Call local carrier to see
  • FedEx – will ship
    • Computer program – document preparation
local transport
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
packaging83
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
labeling84
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
Transporting
  • Sample containers placed in leak-proof, unbreakable
    • Transport Box
      • Secure, tight-fitting cover
      • Biohazard label
  • Frozen specimens
    • Labeled, insulated box w/dry ice
transporting86
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
regulations87
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
regulations88
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
regulations89
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
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
Additional Comments
  • Call ahead of time
    • Clinical/Environmental
    • Let lab know sample is on its way
  • Clinical Specimens
    • Go to Level A Labs for rule-out
  • Environmental Specimens
    • Go to UDOH Lab
  • UDOH has 24/7 coverage
contact information
Contact Information
  • Utah Department of Health Lab Response
    • Kim Christensen – 801-584-8449 kchriste@utah.gov
    • June Pounder – 801-584-8449 jpounder@utah.gov
    • Barbara Jepson – 801-884-8595 bjepson@utah.gov
    • Emergency Pager – 801-241-1172
  • FBI - 801-579-1400