Safe Handling, Packaging & Shipping of Infectious Substances
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Transcript Safe Handling, Packaging & Shipping of Infectious Substances
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