Title: Safe Handling, Packaging
1Safe Handling, Packaging Shipping of Infectious
Substances
- Utah Department of Health
- November 21, 2002
- Kim Christensen
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3Objectives
- Information on possible organisms
- Why these organisms?
- Safety
- Samples
- Packaging
- Transport/Shipping
4Agents of Highest Concern
- Bacillus anthracis (Anthrax)
- Francisella tularensis (Tularemia)
- Yersinia pestis (Plague)
- Botulinum toxin (Botulism)
- Variola major (Smallpox)
- Viral Hemorrhagic Fevers
5Other Possible Agents
- Brucella spp. Brucellosis
- Coxiella burnetti Q-fever
- Arboviruses (West Nile) encephalitis
- Mycotoxins
- Ricin Toxin Castor beans
- SEB Staphylococcus Enterotoxin B
6Why 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
7Bacillus anthracisAnthrax
- Bacillus anthracis
- Gram-positive, spore-forming bacillus (rod)
8Bacillus 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.
9Cutaneous 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
10Inhalation Anthrax
- Inhalation Anthrax-
- A brief prodrome resembling a viral respiratory
illness with radiograph evidence of mediastinal
widening
11Inhalation 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
12Francisella 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
13TularemiaClinical Presentations
- Pneumonic-
- Incubation 3-5 days
- Flu-like symptoms
- Mortality
- 30 untreated
- lt10 treated
- Ulceroglandular
- Ulcer w/adenopathy
- Glandular
- Adenopathy w/o lesion
- Oculoglandular
- Painful, purulent conjunctivitis
- Typhoidal
- Possible presentation for BT
- Septicemia
14Yersinia pestisPlague
- Transmission
- Inhalation
- Direct contact
- Fleas
15PlagueClinical Presentations
- Bubonic
- Flu-like with painful buboes (lymph nodes)
- Septicemic
- Similar to bubonic
- No swelling of lymph nodes
16PlagueClinical Presentations
- Pneumonic
- Highest mortality
- Rapid transmission
- Fever
- Hemoptosis
- Lymphadenopathy
- Cough
17Plague
- Distribution
- Highest in 4 corners area Western states
- Prairie dog population
18Botulism
- Clostridium botulinum
- Organism gram positive, spore-forming,
anaerobic bacilli - Botulinum toxin
- Neurotoxin
- A, B, C1, D, E, F, G
19Botulism
- 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
20Botulism
- 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
21Variola majorSmallpox
- Orthopox virus
- DNA virus
- Brick-shaped structure 200 nm in diameter
- Incubation 8-16 days
- Mortality 30
- Clinical symptoms
- Acute
- Fever
- Headache
- Vomiting
- Backache
22Variola 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)
23Variola majorSmallpox
- Disease Progression
- Incubation Period
- Initial Symptoms Prodrome
- Rash Development Distribution
- Variola minor
- Less common clinical presentation
- Much less severe disease
24Variola majorSmallpox
- Rash
- Begins on face, hands, forearms spreads to
lower extremities within 7 days - Lesions on palms soles of feet
25Variola majorSmallpox
- Rash
- Synchronous progression
macules?vesicles ?pustules ?scabs
26Smallpox
- 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
27Viral Hemorrhagic Fevers
- Yellow fever
- Crimean-Congo
- Rift Valley fever
- Other
- Ebola
- Lassa
- Marburg
- Hanta
- Dengue
28Viral Hemorrhagic Fevers
- High Fever with
- Mucous membrane bleeding
- Petechiae
- Malaise
- Muscle-aches
- Headaches
- May have diarrhea or vomiting
- Fatality depends on virus 90 Ebola
29Viral 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
30Protection of First Responders Health Care
Workers
- Knowledge
- Universal Precautions
- Communication
- Vaccination
- Prophylaxis
31Safety 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
32Safety
- 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/102
42001Protect.asp
33Safety
- Transporter/Shipper
- Know what you might be dealing with
- Protect yourself
- Protect the public
- Follow rules and regulations
- IATA, USPS, DOT, Etc.
34Safety
- 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
35Samples
- Clinical specimens
- Non-clinical
- Environmental
- Evidentiary Materials
36Clinical Specimen SelectionAll clinical
specimens should go directly to a Level A
Laboratory for processing
37Bacillus anthracisAnthrax
- 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
- Institutions procedure
- Routine blood cultures
38Bacillus anthracisAnthrax
- Inhalational
- Sputum
- gt 1 mL expectorated sputum
- Sterile, leakproof container
- Blood
- Institutions procedure
- Routine blood cultures
39Yersinia pestisPlague
- Pneumonic
- Bronchial Wash/Transtracheal Aspirate
- gt 1 ml
- Institutions procedure
- Sputum/Throat
- Routine throat culture (swab)
- Expectorated sputum sterile, leakproof
container
- Septicemic
- Blood
- Institutions procedure
- Routine blood culture
- Bubonic
- Biopsied Specimen
- Liver, spleen, bone marrow, lung
- Tissue aspirate
- May yield little material
40Francisella tularensisTularemia
- Biopsied tissue
- Scraping of an ulcer - preferred
- Swab of an ulcer alternate
- Tissue Aspirate
- Bronchial/Tracheal Wash
- Institutions procedure
- Sputum/Throat
- Routine throat culture
- Sputum expectorated into sterile, leakproof
container - Blood
41Clostridium 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
42Clostridium 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
43Variola majorSmallpox
- Report immediately to UDOH
- UDOH contacts CDC FBI
44Variola 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
45Viral Hemorrhagic Fever
- Specific handling conditions are currently under
development at the CDC. - Serum
- 10-12cc of serum
46Chemical ExposureSpecimens 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
47Non-Clinical SpecimensTo be delivered directly
to the UDOH - Lab
- Animal
- Carcass, tissue, blood, bone, skin
- Vector
- Fleas, mosquitoes, ticks, flies
- Human
- Post-mortem specimens
48Environmental SamplesTo be delivered directly
to the UDOH - Lab
- Water
- At least 500 mL
- Soil/Mud
- Plant Material
- Food
49Evidentiary 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-samplin
g-apr2002.asp
50Chain 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
51Environmental SamplesPlease 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
52Specimen Packaging
- Clinical-
- Containers
- Sterile
- Leak-proof
- Blood collection tubes
- Sterile swabs
- Labeled, individually, with patient ID
- According to institutions protocols
53Specimen 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.
54Packaging Shipping
- Commercial Carriers
-
- Local Transfer
55Regulations
- Protect!
- Postal personnel
- Airline personnel
- Industry personnel
- Made by
- Federal government
- Private industry associations
56Regulations
- Responsibility is given to the SHIPPER!
- Shipper must CORRECTLY
- Classify
- Package
- Label
- Prepare documentation
- For all Diagnostic Infectious Materials
- MUST be Trained Certified!!!
57Regulations
- 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
58Regulations
- Training Certification
- Saf-T-Pak, Inc
- 1-day course Spring 2003 SLC
- 1-800-814-7484
- www.saftpak.com
59Classification
- 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
60Classification
- 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
61Shipment byCommercial Carrier
62Shipment byCommercial Carrier
- Planning
- Packaging
- Labeling
- Documenting
- Shipping
63Planning
- Call Recipient
- Verify shipping address
- Obtain contact name phone
- Verify when to ship
64Packaging
- Includes
- Classification
- Packing
- Labeling
- Documentation
- Must withstand
- Leakage
- Shocks
- Pressure Changes
- Other conditions
- Transport
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66Packaging
- 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
67Packaging
- 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
68Packaging
- 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
69Packaging
- Certified Outer Shipping Package
- Each comes with
- Inner Packaging
- Labels
- Do NOT make any substitutions
- UN-certification becomes invalid
- Refurbishment kits may be used
70Packaging
- Certified Outer Shipping Package
- Closing instructions included
- Over-packs?
- Shipping packs over-packs
- Marked Labeled identically
- Additional Label
- Inner packages comply with prescribed
specifications
71Labeling
- 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
72Labeling
- 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
73Labeling
- 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
74Labeling
- 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
75Labeling
- Address Label
- One side of outer box
- Must include
- Receivers name, shipping address (No PO boxes)
phone (with area code) - Shippers name, address phone
- Temperature/Storage requirements (optional)
76Documenting
- Complete forms letters (enclose w/sample)
- Memo
- All infectious substance shipments
- Letterhead
- Insert on top of 2nd container
- Test request
77Documenting
- Shipping Record File
- Copies of all forms
- Keep 2 years
- Shipping Documents
- Provided by Commercial Carrier
78Documenting
- 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
79Documenting
- Shipping Documents
- All infectious substance shipments require
Dangerous Goods Declaration - To avoid a LARGE fine (gt 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
80Shipping
- Some commercial carriers will NOT ship
- Call local carrier to see
- FedEx will ship
- Computer program document preparation
81Local Transport of Diagnostic Specimens
Infectious Substances
82Local 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
83Packaging
- 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
84Labeling
- 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!!
85Transporting
- Sample containers placed in leak-proof,
unbreakable - Transport Box
- Secure, tight-fitting cover
- Biohazard label
- Frozen specimens
- Labeled, insulated box w/dry ice
86Transporting
- 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
87Regulations
- 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
88Regulations
- 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
89Regulations
- 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
90Other 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
91Additional 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
92Contact Information
- Utah Department of Health Lab Response
- Kim Christensen 801-584-8449 kchriste_at_utah.gov
- June Pounder 801-584-8449 jpounder_at_utah.gov
- Barbara Jepson 801-884-8595 bjepson_at_utah.gov
- Emergency Pager 801-241-1172
- FBI - 801-579-1400
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