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:
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
 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
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
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