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Safe Handling, Packaging

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Title: Safe Handling, Packaging


1
Safe Handling, Packaging Shipping of Infectious
Substances
  • Utah Department of Health
  • November 21, 2002
  • Kim Christensen

2
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3
Objectives
  • Information on possible organisms
  • Why these organisms?
  • Safety
  • Samples
  • Packaging
  • Transport/Shipping

4
Agents of Highest Concern
  • Bacillus anthracis (Anthrax)
  • Francisella tularensis (Tularemia)
  • Yersinia pestis (Plague)
  • Botulinum toxin (Botulism)
  • Variola major (Smallpox)
  • Viral Hemorrhagic Fevers

5
Other Possible Agents
  • Brucella spp. Brucellosis
  • Coxiella burnetti Q-fever
  • Arboviruses (West Nile) encephalitis
  • Mycotoxins
  • Ricin Toxin Castor beans
  • SEB Staphylococcus Enterotoxin B

6
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

7
Bacillus anthracisAnthrax
  • Bacillus anthracis
  • Gram-positive, spore-forming bacillus (rod)

8
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.

9
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

10
Inhalation Anthrax
  • Inhalation Anthrax-
  • A brief prodrome resembling a viral respiratory
    illness with radiograph evidence of mediastinal
    widening

11
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

12
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

13
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

14
Yersinia pestisPlague
  • Transmission
  • Inhalation
  • Direct contact
  • Fleas

15
PlagueClinical Presentations
  • Bubonic
  • Flu-like with painful buboes (lymph nodes)
  • Septicemic
  • Similar to bubonic
  • No swelling of lymph nodes

16
PlagueClinical Presentations
  • Pneumonic
  • Highest mortality
  • Rapid transmission
  • Fever
  • Hemoptosis
  • Lymphadenopathy
  • Cough

17
Plague
  • Distribution
  • Highest in 4 corners area Western states
  • Prairie dog population

18
Botulism
  • Clostridium botulinum
  • Organism gram positive, spore-forming,
    anaerobic bacilli
  • Botulinum toxin
  • Neurotoxin
  • A, B, C1, D, E, F, G

19
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

20
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

21
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

22
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)

23
Variola majorSmallpox
  • Disease Progression
  • Incubation Period
  • Initial Symptoms Prodrome
  • Rash Development Distribution
  • Variola minor
  • Less common clinical presentation
  • Much less severe disease

24
Variola majorSmallpox
  • Rash
  • Begins on face, hands, forearms spreads to
    lower extremities within 7 days
  • Lesions on palms soles of feet

25
Variola majorSmallpox
  • Rash
  • Synchronous progression
    macules?vesicles ?pustules ?scabs

26
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

27
Viral Hemorrhagic Fevers
  • Yellow fever
  • Crimean-Congo
  • Rift Valley fever
  • Other
  • Ebola
  • Lassa
  • Marburg
  • Hanta
  • Dengue

28
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

29
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

30
Protection of First Responders Health Care
Workers
  • Knowledge
  • Universal Precautions
  • Communication
  • Vaccination
  • Prophylaxis

31
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

32
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

33
Safety
  • Transporter/Shipper
  • Know what you might be dealing with
  • Protect yourself
  • Protect the public
  • Follow rules and regulations
  • IATA, USPS, DOT, Etc.

34
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

35
Samples
  • Clinical specimens
  • Non-clinical
  • Environmental
  • Evidentiary Materials

36
Clinical Specimen SelectionAll clinical
specimens should go directly to a Level A
Laboratory for processing
37
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

38
Bacillus anthracisAnthrax
  • Inhalational
  • Sputum
  • gt 1 mL expectorated sputum
  • Sterile, leakproof container
  • Blood
  • Institutions procedure
  • Routine blood cultures

39
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

40
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

41
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

42
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

43
Variola majorSmallpox
  • Report immediately to UDOH
  • UDOH contacts CDC FBI

44
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

45
Viral Hemorrhagic Fever
  • Specific handling conditions are currently under
    development at the CDC.
  • Serum
  • 10-12cc of serum

46
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

47
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

48
Environmental SamplesTo be delivered directly
to the UDOH - Lab
  • Water
  • At least 500 mL
  • Soil/Mud
  • Plant Material
  • Food

49
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

50
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

51
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

52
Specimen Packaging
  • Clinical-
  • Containers
  • Sterile
  • Leak-proof
  • Blood collection tubes
  • Sterile swabs
  • Labeled, individually, with patient ID
  • According to institutions protocols

53
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.

54
Packaging Shipping
  • Commercial Carriers
  • Local Transfer

55
Regulations
  • Protect!
  • Postal personnel
  • Airline personnel
  • Industry personnel
  • Made by
  • Federal government
  • Private industry associations

56
Regulations
  • Responsibility is given to the SHIPPER!
  • Shipper must CORRECTLY
  • Classify
  • Package
  • Label
  • Prepare documentation
  • For all Diagnostic Infectious Materials
  • MUST be Trained Certified!!!

57
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

58
Regulations
  • Training Certification
  • Saf-T-Pak, Inc
  • 1-day course Spring 2003 SLC
  • 1-800-814-7484
  • www.saftpak.com

59
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

60
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

61
Shipment byCommercial Carrier
62
Shipment byCommercial Carrier
  • Planning
  • Packaging
  • Labeling
  • Documenting
  • Shipping

63
Planning
  • Call Recipient
  • Verify shipping address
  • Obtain contact name phone
  • Verify when to ship

64
Packaging
  • Includes
  • Classification
  • Packing
  • Labeling
  • Documentation
  • Must withstand
  • Leakage
  • Shocks
  • Pressure Changes
  • Other conditions
  • Transport

65
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66
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

67
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

68
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
69
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

70
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

71
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

72
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
73
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

     

74
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

     

75
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)

     

76
Documenting
  • Complete forms letters (enclose w/sample)
  • Memo
  • All infectious substance shipments
  • Letterhead
  • Insert on top of 2nd container
  • Test request

77
Documenting
  • Shipping Record File
  • Copies of all forms
  • Keep 2 years
  • Shipping Documents
  • Provided by Commercial Carrier

78
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

79
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

80
Shipping
  • Some commercial carriers will NOT ship
  • Call local carrier to see
  • FedEx will ship
  • Computer program document preparation

81
Local Transport of Diagnostic Specimens
Infectious Substances
82
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

83
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

84
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!!

85
Transporting
  • Sample containers placed in leak-proof,
    unbreakable
  • Transport Box
  • Secure, tight-fitting cover
  • Biohazard label
  • Frozen specimens
  • Labeled, insulated box w/dry ice

86
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

87
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

88
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

89
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

90
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

91
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

92
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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