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-  Glandular
 Adenopathy w/o lesion
 Incubation 3-5 days

 Flu-like symptoms
 Oculoglandular
 Mortality –
 Painful, purulent
 30% untreated conjunctivitis
 <10% treated

 Typhoidal
 Possible presentation for
 Ulceroglandular
BT
 Ulcer w/adenopathy
 Septicemia
 Yersinia pestis
Plague
 Transmission –
 Inhalation

 Direct contact

 Fleas
 Plague
Clinical Presentations
 Bubonic  Septicemic
 Flu-like with  Similar to bubonic

painful buboes  No swelling of

(lymph nodes) 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, spore-
forming, anaerobic
bacilli
 Botulinum toxin
 Neurotoxin

A, B, C1, D, E, F, G
 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
 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  Incubation 8-16 days
 DNA virus  Mortality 30%
 Brick-shaped structure  Clinical symptoms
200 nm in diameter  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:
maculesvesicles
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  Yellow fever

 Lassa  Crimean-Congo

 Marburg  Rift Valley fever

 Hanta  Other

 Dengue
 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  Gastrointestinal
 Vesicular Stage  Stool

 5-10 grams
 Fluid from intact
vesicles on sterile  Sterile, leakproof
swab container
 Eschar Stage  Rectal swab

 Without removing  Blood

eschar, rotate swab  Institution’s
beneath edge of
procedure
eschar & collect
 Routine blood
lesion material
cultures
 Bacillus anthracis
Anthrax
 Inhalational
 Sputum

 > 1 mL expectorated sputum

 Sterile, leakproof container

 Blood

 Institution’s procedure

 Routine blood cultures

 Yersinia pestis
Plague
 Pneumonic  Septicemic
 Bronchial  Blood

Wash/Transtracheal  Institution’s
Aspirate procedure
 > 1 ml  Routine blood
 Institution’s culture
procedure  Bubonic
 Sputum/Throat  Biopsied Specimen
 Routine throat  Liver, spleen, bone
culture (swab) marrow, lung
 Expectorated  Tissue aspirate
sputum – sterile,  May yield little
leakproof container 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  Infant
 Clinical Material  Stool
 Serum  Enema fluid
 Gastric contents
 Post-mortem
 Vomitus
 Stool samples (intestinal
 Enema fluid contents)
 Autopsy Samples  Food samples

 Intestinal & Gastic  Environmental

contents
Samples
 Serum
 Food Samples
 Clostridium botulinum
& Botulism Toxin
 Wound  Bioterrorism –
 Serum Intentional Release
 Wound tissue,  Serum

exudate, swab  Stool

 Anaerobic  Enema fluid

transport  Gastric aspirate

 Stool  Nasal swab
 Enema fluid  Food samples
 Isolate  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  Whole Blood
 At least 25 mL  One 5 mL or 7 mL
 Screw-cap plastic gray-top or green-top
containers tube (unopened)
 Freeze ASAP
 One empty tube

 Whole Blood
 Whole Blood  Two 10 mL red-top
 Two – 5 or 7 mL tubes
purple-top (EDTA)
tubes – vacuum-fill
 no anticoagulant
only (unopened)  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
 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
 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  FBI or HAZMAT
determined to be a should pre-screen
credible threat samples for:
 Bombs
 Determined by
 Incendiary
FBI/Local law
enforcement Devices
 Radiological
 Directly related to
Materials
an event  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:  Must withstand:

 Classification  Leakage

 Packing  Shocks

 Labeling  Pressure Changes

 Documentation  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/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
 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