Safe Handling, Packaging

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Safe Handling, Packaging Shipping of Infectious
Substances

• Utah Department of Health
• November 21, 2002
• Kim Christensen

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Objectives

• Information on possible organisms
• Why these organisms?
• Safety
• Samples
• Packaging
• Transport/Shipping

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Agents of Highest Concern

• Bacillus anthracis (Anthrax)
• Francisella tularensis (Tularemia)
• Yersinia pestis (Plague)
• Botulinum toxin (Botulism)
• Variola major (Smallpox)
• Viral Hemorrhagic Fevers

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Other Possible Agents

• Brucella spp. Brucellosis
• Coxiella burnetti Q-fever
• Arboviruses (West Nile) encephalitis
• Mycotoxins
• Ricin Toxin Castor beans
• SEB Staphylococcus Enterotoxin B

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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

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Bacillus anthracisAnthrax

• Bacillus anthracis
• Gram-positive, spore-forming bacillus (rod)

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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.

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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

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Inhalation Anthrax

• Inhalation Anthrax-
• A brief prodrome resembling a viral respiratory
  illness with radiograph evidence of mediastinal
  widening

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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

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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

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TularemiaClinical 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

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Yersinia pestisPlague

• Transmission
• Inhalation
• Direct contact
• Fleas

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PlagueClinical Presentations

• Bubonic
• Flu-like with painful buboes (lymph nodes)

• Septicemic
• Similar to bubonic
• No swelling of lymph nodes

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PlagueClinical Presentations

• Pneumonic
• Highest mortality
• Rapid transmission
• Fever
• Hemoptosis
• Lymphadenopathy
• Cough

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Plague

• Distribution
• Highest in 4 corners area Western states
• Prairie dog population

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Botulism

• Clostridium botulinum
• Organism gram positive, spore-forming,
  anaerobic bacilli
• Botulinum toxin
• Neurotoxin
• A, B, C1, D, E, F, G

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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

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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

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Variola 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

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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)

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Variola majorSmallpox

• Disease Progression
• Incubation Period
• Initial Symptoms Prodrome
• Rash Development Distribution
• Variola minor
• Less common clinical presentation
• Much less severe disease

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Variola majorSmallpox

• Rash
• Begins on face, hands, forearms spreads to
  lower extremities within 7 days
• Lesions on palms soles of feet

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Variola majorSmallpox

• Rash
• Synchronous progression
  macules?vesicles ?pustules ?scabs

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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

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Viral Hemorrhagic Fevers

• Yellow fever
• Crimean-Congo
• Rift Valley fever
• Other

• Ebola
• Lassa
• Marburg
• Hanta
• Dengue

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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

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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

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Protection of First Responders Health Care
Workers

• Knowledge
• Universal Precautions
• Communication
• Vaccination
• Prophylaxis

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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

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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/102
  42001Protect.asp

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Safety

• Transporter/Shipper
• Know what you might be dealing with
• Protect yourself
• Protect the public
• Follow rules and regulations
• IATA, USPS, DOT, Etc.

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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

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Samples

• Clinical specimens
• Non-clinical
• Environmental
• Evidentiary Materials

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Clinical Specimen SelectionAll clinical
specimens should go directly to a Level A
Laboratory for processing
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Bacillus 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

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Bacillus anthracisAnthrax

• Inhalational
• Sputum
• gt 1 mL expectorated sputum
• Sterile, leakproof container
• Blood
• Institutions procedure
• Routine blood cultures

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Yersinia 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

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Francisella 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

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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

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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

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Variola majorSmallpox

• Report immediately to UDOH
• UDOH contacts CDC FBI

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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

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Viral Hemorrhagic Fever

• Specific handling conditions are currently under
  development at the CDC.
• Serum
• 10-12cc of serum

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Chemical 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

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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

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Environmental SamplesTo be delivered directly
to the UDOH - Lab

• Water
• At least 500 mL
• Soil/Mud
• Plant Material
• Food

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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-samplin
  g-apr2002.asp

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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

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Environmental 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

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Specimen Packaging

• Clinical-
• Containers
• Sterile
• Leak-proof
• Blood collection tubes
• Sterile swabs
• Labeled, individually, with patient ID
• According to institutions protocols

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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.

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Packaging Shipping

• Commercial Carriers
• Local Transfer

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Regulations

• Protect!
• Postal personnel
• Airline personnel
• Industry personnel
• Made by
• Federal government
• Private industry associations

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Regulations

• Responsibility is given to the SHIPPER!
• Shipper must CORRECTLY
• Classify
• Package
• Label
• Prepare documentation
• For all Diagnostic Infectious Materials
• MUST be Trained Certified!!!

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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

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Regulations

• Training Certification
• Saf-T-Pak, Inc
• 1-day course Spring 2003 SLC
• 1-800-814-7484
• www.saftpak.com

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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

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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

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Shipment byCommercial Carrier
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Shipment byCommercial Carrier

• Planning
• Packaging
• Labeling
• Documenting
• Shipping

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Planning

• Call Recipient
• Verify shipping address
• Obtain contact name phone
• Verify when to ship

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Packaging

• Includes
• Classification
• Packing
• Labeling
• Documentation

• Must withstand
• Leakage
• Shocks
• Pressure Changes
• Other conditions
• Transport

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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

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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

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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
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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

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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

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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

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Labeling

• Hazard Class 6.2 Infectious Substances

     
Etiologic agents Biomedical material In
case of damage or leakage Notify Director CDC,
Atlanta, Georgia [phone]
Apply on the blank diamond marked on
outside package
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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

     

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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

     

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Labeling

• 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)

     

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Documenting

• Complete forms letters (enclose w/sample)
• Memo
• All infectious substance shipments
• Letterhead
• Insert on top of 2nd container
• Test request

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Documenting

• Shipping Record File
• Copies of all forms
• Keep 2 years
• Shipping Documents
• Provided by Commercial Carrier

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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

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Documenting

• 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

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Shipping

• Some commercial carriers will NOT ship
• Call local carrier to see
• FedEx will ship
• Computer program document preparation

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Local Transport of Diagnostic Specimens
Infectious Substances
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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

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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

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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!!

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Transporting

• Sample containers placed in leak-proof,
  unbreakable
• Transport Box
• Secure, tight-fitting cover
• Biohazard label
• Frozen specimens
• Labeled, insulated box w/dry ice

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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

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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

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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

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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

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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

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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

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Contact 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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