safe handling, packaging & shipping of infectious substances

Safe Handling, Packaging & Shipping of Infectious

Substances

Utah Department of HealthUtah Department of Health

November 21, 2002November 21, 2002

Kim ChristensenKim Christensen

Objectives

Information on possible organismsInformation on possible organisms Why these organisms?Why these organisms? SafetySafety SamplesSamples PackagingPackaging Transport/ShippingTransport/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. Brucella spp. – Brucellosis– Brucellosis Coxiella burnettiCoxiella burnetti – Q-fever – Q-fever Arboviruses (West Nile) – encephalitisArboviruses (West Nile) – encephalitis MycotoxinsMycotoxins Ricin Toxin – Castor beansRicin Toxin – Castor beans SEB – SEB – Staphylococcus Staphylococcus Enterotoxin BEnterotoxin B

Why these organisms?

Can cause disease via aerosol routeCan cause disease via aerosol route Fairly stable in aerosolized formFairly stable in aerosolized form Susceptible civilian populationSusceptible civilian population High morbidity and mortality ratesHigh morbidity and mortality rates Difficult to diagnose and/or treatDifficult to diagnose and/or treat SomeSome can be transmitted person-to-person can be transmitted person-to-person

Bacillus anthracisAnthrax

Bacillus anthracis –

Gram-positive, spore-forming bacillus (rod)

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.

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 tularensisTularemia

Humans become infected by:Humans become infected by: Handling infected animal carcassesHandling infected animal carcasses

““Rabbit Fever”Rabbit Fever” Bites of ticks, deer flies, or mosquitoesBites of ticks, deer flies, or mosquitoes

No person-to-person transmissionNo person-to-person transmission Endemic in UtahEndemic in Utah

TularemiaClinical Presentations

Pneumonic-Pneumonic- Incubation 3-5 daysIncubation 3-5 days Flu-like symptomsFlu-like symptoms Mortality –Mortality –

30% untreated30% untreated <10% treated<10% treated

UlceroglandularUlceroglandular Ulcer w/adenopathyUlcer w/adenopathy

GlandularGlandular Adenopathy w/o lesionAdenopathy w/o lesion

OculoglandularOculoglandular Painful, purulent Painful, purulent

conjunctivitisconjunctivitis

TyphoidalTyphoidal Possible presentation Possible presentation

for BTfor BT SepticemiaSepticemia

Yersinia pestisPlague

Transmission –Transmission – InhalationInhalation Direct contactDirect contact FleasFleas

PlagueClinical Presentations

BubonicBubonic Flu-like with Flu-like with

painful buboes painful buboes (lymph nodes)(lymph nodes)

SepticemicSepticemic Similar to bubonicSimilar to bubonic No swelling of No swelling of

lymph nodeslymph nodes

PlagueClinical Presentations

PneumonicPneumonic Highest mortalityHighest mortality Rapid transmissionRapid transmission FeverFever HemoptosisHemoptosis LymphadenopathyLymphadenopathy CoughCough

Plague

Distribution Distribution Highest in 4 corners area – Western Highest in 4 corners area – Western

statesstates

Prairie dog populationPrairie dog population

Botulism

Clostridium botulinumClostridium botulinum Organism – gram Organism – gram

positive, spore-positive, spore-forming, anaerobic forming, anaerobic bacillibacilli

Botulinum toxinBotulinum toxin Neurotoxin Neurotoxin

A, B, C1, D, E, F, A, B, C1, D, E, F, GG

Botulism FoodborneFoodborne

Diplopia (double vision), blurred vision, flaccid, Diplopia (double vision), blurred vision, flaccid, symmetric paralysis (rapid progression)symmetric paralysis (rapid progression)

InfantInfant Constipation, poor-feeding, “failure to thrive”, Constipation, poor-feeding, “failure to thrive”,

weakness, impaired respiration and deathweakness, impaired respiration and death

WoundWound Same symptoms as foodborne w/infection through a Same symptoms as foodborne w/infection through a

woundwound

OtherOther Non-infant patient with no suspect food or woundNon-infant patient with no suspect food or wound

Botulism FoodborneFoodborne

Most likely presentation for BT eventMost likely presentation for BT event MortalityMortality

Currently 5-10%Currently 5-10%Previously 60%Previously 60%

WoundWound Mortality 15%Mortality 15% Emerging problem of drug usersEmerging problem of drug users

Injecting Black Tar HeroinInjecting Black Tar Heroin

Variola majorSmallpox

Orthopox virusOrthopox virus DNA virusDNA virus Brick-shaped structure Brick-shaped structure

200 nm in diameter200 nm in diameter

Incubation 8-16 daysIncubation 8-16 days Mortality 30%Mortality 30% Clinical symptomsClinical symptoms

AcuteAcuteFeverFeverHeadacheHeadacheVomitingVomitingBackacheBackache


4 Types4 Types 1. Ordinary – most frequent1. Ordinary – most frequent 2. Modified 2. Modified

• MildMild• Occurring in previously vaccinated Occurring in previously vaccinated

personspersons 3. Flat3. Flat 4. Hemorrhagic4. Hemorrhagic

• Much shorter incubationMuch shorter incubation• Not likely to be recognized as Smallpox Not likely to be recognized as Smallpox

(initially)(initially)


Disease ProgressionDisease Progression Incubation PeriodIncubation Period Initial Symptoms – ProdromeInitial Symptoms – Prodrome Rash Development & DistributionRash Development & Distribution

Variola minorVariola minor Less common clinical presentationLess common clinical presentation Much less severe diseaseMuch less severe disease


RashRash Begins on face, Begins on face,

hands, forearms & hands, forearms & spreads to lower spreads to lower extremities within 7 extremities within 7 daysdays

Lesions on palms & Lesions on palms & soles of feetsoles of feet


RashRash Synchronous Synchronous

progression: progression: maculesmaculesvesicles vesicles pustules pustules scabsscabs

Smallpox

Spread by infected dropletsSpread by infected droplets Most infectious after onset of rashMost infectious after onset of rash Contagious until the last scab falls offContagious until the last scab falls off Vaccine given within 4 days of exposure Vaccine given within 4 days of exposure

can prevent disease or lessen symptomscan prevent disease or lessen symptoms 70% recovery rate70% recovery rate Chicken pox vs. SmallpoxChicken pox vs. Smallpox

Viral Hemorrhagic Fevers

EbolaEbola LassaLassa MarburgMarburg HantaHanta DengueDengue

Yellow feverYellow fever Crimean-CongoCrimean-Congo Rift Valley feverRift Valley fever OtherOther


High Fever High Fever with:with: Mucous membrane bleedingMucous membrane bleeding PetechiaePetechiae MalaiseMalaise Muscle-achesMuscle-aches HeadachesHeadaches May have diarrhea or vomitingMay have diarrhea or vomiting

Fatality depends on virus – 90% EbolaFatality depends on virus – 90% Ebola


Mosquito or tick vectorsMosquito or tick vectors Person-to-person transmission through body Person-to-person transmission through body

fluids/bloodfluids/blood Vaccine available for Yellow FeverVaccine available for Yellow Fever People can be infected but show no signs or People can be infected but show no signs or

symptoms of diseasesymptoms of disease

Protection of First Responders & Health Care Workers

Knowledge Universal Precautions Communication Vaccination Prophylaxis

Safety First First RespondersFirst Responders

Personal Protective EquipmentPersonal Protective Equipment Established protocolsEstablished protocols

TransportersTransporters RegulationsRegulations

Lab PersonnelLab Personnel Personal Protective EquipmentPersonal Protective Equipment Established protocolsEstablished protocols Biosafety ContainmentBiosafety Containment VaccinationsVaccinations

Use Use Universal PrecautionsUniversal Precautions – treat everything as – treat everything as if it were contaminatedif it were contaminated

Safety First RespondersFirst Responders

Know what you “might be” dealing withKnow what you “might be” dealing with Protect yourselfProtect yourself Protect the communityProtect the community Protect the next in line (transporter)Protect the next in line (transporter) Recommendations for the Selection and Use of Recommendations for the Selection and Use of

Protective Clothing & Respirators Against Protective Clothing & Respirators Against Biological Agents:Biological Agents:

www.bt.cdc.gov/DocumentsApp/Anthrax/Protective/www.bt.cdc.gov/DocumentsApp/Anthrax/Protective/10242001Protect.asp10242001Protect.asp

Safety

Transporter/ShipperTransporter/Shipper Know what you “might be” dealing withKnow what you “might be” dealing with Protect yourself Protect yourself Protect the publicProtect the public Follow rules and regulationsFollow rules and regulations

IATA, USPS, DOT, Etc.IATA, USPS, DOT, Etc.

Safety

Laboratory PersonnelLaboratory Personnel Handle & process according to Biosafety Level Handle & process according to Biosafety Level

Classifications (Level 1, Level 2, Level 3, Classifications (Level 1, Level 2, Level 3, Level 4)Level 4)

Biosafety in Microbiological & Biomedical Laboratories Biosafety in Microbiological & Biomedical Laboratories CDC/NIH, 4CDC/NIH, 4thth Edition. Edition.

Protect yourselfProtect yourself Protect other laboratoriansProtect other laboratorians Protect the publicProtect the public

Samples

Clinical specimensClinical specimens

Non-clinicalNon-clinical

EnvironmentalEnvironmental

Evidentiary MaterialsEvidentiary Materials

Clinical SpecimenSpecimen Selection

All clinical specimens should go directly to a Level A Laboratory for processing

Bacillus anthracisBacillus anthracisAnthraxAnthrax

CutaneousCutaneous Vesicular StageVesicular Stage

Fluid from intact Fluid from intact vesicles on sterile vesicles on sterile swabswab

Eschar StageEschar Stage Without removing Without removing

eschar, rotate swab eschar, rotate swab beneath edge of beneath edge of eschar & collect eschar & collect lesion materiallesion material

GastrointestinalGastrointestinal StoolStool

5-10 grams5-10 gramsSterile, leakproof Sterile, leakproof

containercontainerRectal swab Rectal swab

BloodBloodInstitution’s Institution’s

procedureprocedureRoutine blood Routine blood

culturescultures

Bacillus anthracisBacillus anthracisAnthraxAnthrax

InhalationalInhalational SputumSputum

> 1 mL expectorated sputum> 1 mL expectorated sputumSterile, leakproof containerSterile, leakproof container

BloodBloodInstitution’s procedureInstitution’s procedureRoutine blood culturesRoutine blood cultures

Yersinia pestisYersinia pestisPlaguePlague

PneumonicPneumonic Bronchial Bronchial

Wash/Transtracheal Wash/Transtracheal AspirateAspirate

>> 1 ml 1 ml Institution’s Institution’s

procedure procedure Sputum/ThroatSputum/Throat

Routine throat Routine throat culture (swab)culture (swab)

Expectorated Expectorated sputum – sterile, sputum – sterile, leakproof containerleakproof container

SepticemicSepticemic BloodBlood

Institution’s Institution’s procedureprocedure

Routine blood Routine blood cultureculture

BubonicBubonic Biopsied SpecimenBiopsied Specimen

Liver, spleen, bone Liver, spleen, bone marrow, lungmarrow, lung

Tissue aspirateTissue aspirate May yield little May yield little

materialmaterial

Francisella tularensisFrancisella tularensisTularemiaTularemia

Biopsied tissueBiopsied tissue Scraping of an ulcer - preferredScraping of an ulcer - preferred Swab of an ulcer – alternateSwab of an ulcer – alternate

Tissue AspirateTissue Aspirate Bronchial/Tracheal WashBronchial/Tracheal Wash

Institution’s procedureInstitution’s procedure Sputum/ThroatSputum/Throat

Routine throat cultureRoutine throat culture Sputum expectorated into sterile, leakproof Sputum expectorated into sterile, leakproof

containercontainer BloodBlood

Clostridium botulinumClostridium botulinum & & Botulism ToxinBotulism Toxin

FoodborneFoodborne Clinical MaterialClinical Material

SerumSerum Gastric contentsGastric contents VomitusVomitus StoolStool Enema fluidEnema fluid

Autopsy SamplesAutopsy Samples Intestinal & Gastic Intestinal & Gastic

contentscontents SerumSerum

Food SamplesFood Samples

InfantInfant StoolStool Enema fluidEnema fluid Post-mortem Post-mortem

samples (intestinal samples (intestinal contents)contents)

Food samplesFood samples Environmental Environmental

SamplesSamples

Clostridium botulinumClostridium botulinum & & Botulism ToxinBotulism Toxin

WoundWound SerumSerum Wound tissue, Wound tissue,

exudate, swabexudate, swabAnaerobic Anaerobic

transporttransport StoolStool Enema fluidEnema fluid IsolateIsolate

Bioterrorism – Bioterrorism – Intentional ReleaseIntentional Release SerumSerum StoolStool Enema fluidEnema fluid Gastric aspirateGastric aspirate Nasal swabNasal swab Food samplesFood samples Environmental Environmental

samplessamples

Variola majorVariola majorSmallpoxSmallpox

Report immediately to Report immediately to UDOHUDOH

UDOHUDOH contacts contacts CDC & FBICDC & FBI

Variola majorVariola majorSmallpoxSmallpox

Biopsy SpecimenBiopsy Specimen 2-4 portions of tissue2-4 portions of tissue Sterile, leakproof, freezable containerSterile, leakproof, freezable container

ScabsScabs Scrapings/materialScrapings/material Sterile, leakproof, freezable containerSterile, leakproof, freezable container

Vesicular fluidVesicular fluid Separate lesionsSeparate lesions Include cellular materialInclude cellular material

Viral Hemorrhagic Fever

Specific handling conditions are currently Specific handling conditions are currently under development at the CDC.under development at the CDC.

SerumSerum 10-12cc of serum10-12cc of serum

Chemical ExposureSpecimens to be collected from each individual

UrineUrine At least 25 mLAt least 25 mL Screw-cap plastic Screw-cap plastic

containers containers Freeze ASAPFreeze ASAP

Whole BloodWhole Blood Two – 5 or 7 mL Two – 5 or 7 mL

purple-top (EDTA) purple-top (EDTA) tubes – vacuum-fill tubes – vacuum-fill only (unopened)only (unopened)

Whole BloodWhole Blood One 5 mL or 7 mL One 5 mL or 7 mL

gray-top or green-top gray-top or green-top tube (unopened)tube (unopened)

One empty tubeOne empty tube

Whole BloodWhole Blood Two 10 mL red-top Two 10 mL red-top

tubes tubes no anticoagulantno anticoagulant Do not separate serum Do not separate serum

from cellsfrom cells

Non-Clinical Specimens

To be delivered directly to the UDOH - Lab

AnimalAnimal Carcass, tissue, blood, bone, skinCarcass, tissue, blood, bone, skin

VectorVector Fleas, mosquitoes, ticks, fliesFleas, mosquitoes, ticks, flies

HumanHuman Post-mortem specimensPost-mortem specimens

Environmental Samples

To be delivered directly to the UDOH - Lab

WaterWater At least 500 mLAt least 500 mL

Soil/MudSoil/Mud

Plant MaterialPlant Material

FoodFood

Evidentiary MaterialsTo be delivered directly to the UDOH - Lab

Non-organicsNon-organics PowderPowder PaperPaper ContainersContainers

OrganicsOrganics HairHair WoodWood LiquidsLiquids

Example procedure for collecting environmental Example procedure for collecting environmental samples:samples: www.bt.cdc.gov/Agent/Anthrax/environmental-www.bt.cdc.gov/Agent/Anthrax/environmental-

sampling-apr2002.aspsampling-apr2002.asp

Chain of Custody

Always observe a Chain of CustodyAlways observe a Chain of Custody EvidenceEvidence

CollectorCollectorTransporter Transporter LaboratoryLaboratory Each person to touch the sample must sign for Each person to touch the sample must sign for

it.it. Laboratory –Laboratory –

Signed for each time the sample is manipulatedSigned for each time the sample is manipulated

Environmental SamplesPlease Pre-screen

Sample should be Sample should be determined to be a determined to be a credible threatcredible threat Determined by Determined by

FBI/Local law FBI/Local law enforcementenforcement

Directly related to Directly related to an eventan event

FBI or HAZMAT FBI or HAZMAT should should pre-screenpre-screen samples for:samples for: BombsBombs Incendiary Incendiary

DevicesDevices Radiological Radiological

MaterialsMaterials ChemicalsChemicals

Specimen Packaging

Clinical-Clinical- Containers:Containers:

SterileSterileLeak-proofLeak-proofBlood collection tubesBlood collection tubesSterile swabsSterile swabs

Labeled, individually, with patient IDLabeled, individually, with patient ID According to institution’s protocolsAccording to institution’s protocols

Specimen Packaging Non-clinical-Non-clinical-

Original containers – if possibleOriginal containers – if possible1. Sample placed in sealed, clean, dry 1. Sample placed in sealed, clean, dry container – Ziplock bags okay container – Ziplock bags okay2. Change gloves2. Change gloves3. Sample placed in 23. Sample placed in 2ndnd container container a. In a clean areaa. In a clean area

b. Seal 2b. Seal 2ndnd container container4. Change gloves4. Change gloves5. Decontaminate outer container with 10% 5. Decontaminate outer container with 10%

bleach solution bleach solution OR OR add a 3add a 3rdrd container. container.

Packaging & Shipping

Commercial CarriersCommercial Carriers

&&

Local TransferLocal Transfer

Regulations Protect!Protect!

Postal personnelPostal personnel Airline personnelAirline personnel Industry personnelIndustry personnel

Made by:Made by: Federal governmentFederal government Private industry associationsPrivate industry associations

Regulations ResponsibilityResponsibility is given to the is given to the SHIPPERSHIPPER!!

Shipper must Shipper must CORRECTLYCORRECTLY::ClassifyClassifyPackagePackageLabelLabelPrepare documentationPrepare documentationFor all For all Diagnostic & InfectiousDiagnostic & Infectious Materials MaterialsMUST be Trained & Certified!!!MUST be Trained & Certified!!!

Regulations Training & CertificationTraining & Certification

Anyone directly involved with the Anyone directly involved with the shipping of diagnostic materials or shipping of diagnostic materials or infectious substances.infectious substances.

1 individual per institution must be 1 individual per institution must be trained.trained.By certified training authorityBy certified training authority

That person trains othersThat person trains others

Regulations

Training & CertificationTraining & Certification Saf-T-Pak, IncSaf-T-Pak, Inc

1-day course – Spring 2003 – SLC1-day course – Spring 2003 – SLC1-800-814-74841-800-814-7484www.saftpak.comwww.saftpak.com

Classification Diagnostic Specimen vs. Infectious SubstanceDiagnostic Specimen vs. Infectious Substance

Diagnostic SpecimenDiagnostic SpecimenNot considered hazardousNot considered hazardousPoses negligible threatPoses negligible threatLow probability of containing Low probability of containing

pathogenspathogensTesting other than for presence of Testing other than for presence of

pathogenspathogensHave not been tested yetHave not been tested yet

Classification Diagnostic Specimen vs. Infectious Diagnostic Specimen vs. Infectious

SubstanceSubstance Infectious Substance:Infectious Substance:

Same as Hazardous MaterialSame as Hazardous MaterialContains or Suspected to contain agent Contains or Suspected to contain agent

that may cause infection that may cause infection (bacteria/virus)(bacteria/virus)

Human/Animal samples likely to Human/Animal samples likely to contain an infectious agentcontain an infectious agent

Shipment byCommercial Carrier

Shipment byCommercial Carrier

PlanningPlanning PackagingPackaging LabelingLabeling DocumentingDocumenting ShippingShipping

Planning

Call Recipient:Call Recipient:

Verify shipping Verify shipping addressaddress

Obtain contact Obtain contact name & phonename & phone

Verify when to shipVerify when to ship

Packaging

Includes:Includes: ClassificationClassification PackingPacking LabelingLabeling DocumentationDocumentation

Must withstand:Must withstand: LeakageLeakage ShocksShocks Pressure ChangesPressure Changes Other conditionsOther conditions

TransportTransport

Packaging Primary Sample ContainerPrimary Sample Container

Waterproof & Leak-proofWaterproof & Leak-proof Seal plates/tubes with tapeSeal plates/tubes with tape Wrap specimen container in absorbent materialWrap specimen container in absorbent material

Enough to absorb entire liquid contentsEnough to absorb entire liquid contents Ziplock Biohazard bagZiplock Biohazard bag

Solids – 1 bagSolids – 1 bagLiquids – 2 bagsLiquids – 2 bags

Pre-freeze specimens if shipping frozenPre-freeze specimens if shipping frozen

Packaging Secondary ContainerSecondary Container

Complete Packaging SystemComplete Packaging SystemUnbreakableUnbreakableWater-proofWater-proofLeak-proofLeak-proofBiohazard LabelBiohazard Label

Commercial Suppliers of Certified Packaging Commercial Suppliers of Certified Packaging SystemsSystems

i.e. Saf-T-Pak, EXAKT-PAKi.e. Saf-T-Pak, EXAKT-PAK

Packaging Certified Outer Shipping PackageCertified Outer Shipping Package

Strong enough to hold capacity & massStrong enough to hold capacity & massIndicated on the bottom of boxIndicated on the bottom of box

Choose appropriate packageChoose appropriate package Must meet UN Class 6.2 SpecsMust meet UN Class 6.2 Specs

Must bear the UN Packaging Must bear the UN Packaging Specification MarkingSpecification Marking

4G CLASS 6.2 / 994G CLASS 6.2 / 99

CAN / 8-2 SAF-T-PAKCAN / 8-2 SAF-T-PAKUN

Packaging

Certified Outer Shipping PackageCertified Outer Shipping Package Each comes with:Each comes with:

Inner PackagingInner PackagingLabelsLabels

Do NOT make any substitutionsDo NOT make any substitutionsUN-certification becomes invalidUN-certification becomes invalid

Refurbishment kits may be usedRefurbishment kits may be used

Packaging

Certified Outer Shipping PackageCertified Outer Shipping Package Closing instructions includedClosing instructions included Over-packs?Over-packs?

Shipping packs & over-packs Shipping packs & over-packs

• Marked & Labeled identicallyMarked & Labeled identically

• Additional Label:Additional Label:

““Inner packages comply with Inner packages comply with prescribed specificationsprescribed specifications””

Labeling

Apply to flat surface w/o overlap or corner Apply to flat surface w/o overlap or corner wrapwrap

HAZARDHAZARD Labels for Dangerous Goods Labels for Dangerous Goods Must be displayed on packages Must be displayed on packages

containing:containing:Infectious substancesInfectious substancesDry iceDry ice

Labeling Hazard Class 6.2 Hazard Class 6.2 Infectious SubstancesInfectious Substances

Etiologic agentsBiomedical material

In case of damage or leakageNotify Director CDC, Atlanta, Georgia

(404) 633-5313

Apply on the blank diamond marked on outside package

Labeling Miscellaneous Hazard Class 9Miscellaneous Hazard Class 9 Dry Ice Dry Ice

Weight of dry ice in kgWeight of dry ice in kg Handwritten on labelHandwritten on label Apply on side opposite Hazardous Apply on side opposite Hazardous

Substance labelSubstance label UN Shipping Name Label for Dry IceUN Shipping Name Label for Dry Ice

Carbon dioxide, solidCarbon dioxide, solid (Dry Ice)(Dry Ice)

UN1845UN1845_______kg_______kg

Next to Dry Ice Hazard LabelNext to Dry Ice Hazard Label

Labeling Orientation LabelsOrientation Labels

Opposite sides of shipping containerOpposite sides of shipping containerDo not cover the hazard labelsDo not cover the hazard labels

UN Shipping Name LabelUN Shipping Name Label Required for Required for EACH EACH Infectious OrganismInfectious Organism

Infectious substances,Infectious substances,

Affecting humansAffecting humans

(Escherichia coli)(Escherichia coli)

UN2814UN2814

X _________mLX _________mL

Apply next to Hazard Class 6.2 labelApply next to Hazard Class 6.2 label

Labeling

Address LabelAddress Label One side of outer boxOne side of outer box Must include:Must include:

Receiver’s name, shipping address (No Receiver’s name, shipping address (No PO boxes) & phone (with area code)PO boxes) & phone (with area code)

Shipper’s name, address & phoneShipper’s name, address & phoneTemperature/Storage requirements Temperature/Storage requirements

(optional)(optional)

Documenting

Complete Complete forms & lettersforms & letters (enclose (enclose w/sample)w/sample) MemoMemo

All infectious substance shipmentsAll infectious substance shipmentsLetterheadLetterheadInsert on top of 2Insert on top of 2ndnd container container

Test requestTest request

Documenting

Shipping Record FileShipping Record File Copies of all formsCopies of all forms Keep 2 yearsKeep 2 years

Shipping DocumentsShipping Documents Provided by Commercial CarrierProvided by Commercial Carrier

Documenting Shipping DocumentsShipping Documents

Commercial Air Shipments require:Commercial Air Shipments require:Air WaybillAir Waybill

• Name & telephone # responsible personName & telephone # responsible person• Person should be Person should be

– KnowledgeableKnowledgeable– Accessible 24/7Accessible 24/7

• Shipping pouch (address window)Shipping pouch (address window)– Top surface of closed packageTop surface of closed package

Documenting Shipping DocumentsShipping Documents

All infectious substance shipments All infectious substance shipments require: require: Dangerous Goods DeclarationDangerous Goods DeclarationTo avoid a LARGE fine (> $1000)To avoid a LARGE fine (> $1000)

• Forms in shipping pouch & apply Forms in shipping pouch & apply pouch to bottom of packagepouch to bottom of package

• Edges of pouch cannot overlap any Edges of pouch cannot overlap any of the labels or markings on the sideof the labels or markings on the side

Shipping

Some commercial carriers will NOT ship Some commercial carriers will NOT ship Call local carrier to seeCall local carrier to see

FedEx – will shipFedEx – will ship Computer program – document Computer program – document

preparation preparation

Local Transport of Diagnostic Specimens & Infectious

Substances

Local Transport

Usually courier serviceUsually courier service Transfer of specimens from:Transfer of specimens from:

Dr.’s office/hospital Dr.’s office/hospital Laboratory Laboratory Laboratory Laboratory Laboratory Laboratory

As important as air transportAs important as air transport No possibility of contents escaping under No possibility of contents escaping under

normal transport conditionsnormal transport conditions

Packaging Primary Sample ContainerPrimary Sample Container

Water-proofWater-proof Leak-proofLeak-proof Seal plates/tubes with tapeSeal plates/tubes with tape Wrap absorbent material around Wrap absorbent material around

specimen container and securespecimen container and secure Ziplock Biohazard bagZiplock Biohazard bag

Solids – 1 bagSolids – 1 bagLiquids – 2 bagsLiquids – 2 bags

Labeling

Label with:Label with: Name, address & phone of recipientName, address & phone of recipient Storage requirementsStorage requirements

ID form/test requestID form/test request Outside pocket of biohazard bagOutside pocket of biohazard bag Do Do NOTNOT put forms inside with the put forms inside with the

specimen!!specimen!!

Transporting

Sample containers placed in Sample containers placed in leak-proofleak-proof, , unbreakableunbreakable Transport BoxTransport Box

Secure, tight-fitting coverSecure, tight-fitting coverBiohazard labelBiohazard label

Frozen specimensFrozen specimens Labeled, insulated box w/dry iceLabeled, insulated box w/dry ice

Transporting Transport box Transport box

Carried to courier vehicleCarried to courier vehicleSecure in position for transportSecure in position for transportVERY IMPORTANT!!VERY IMPORTANT!!

Courier VehicleCourier Vehicle Should carry a spill kit with:Should carry a spill kit with:

Absorbent materialAbsorbent materialDisposable glovesDisposable glovesChlorine disinfectantChlorine disinfectantLeak-proof waste disposal containerLeak-proof waste disposal container

Regulations

Public Health Service 42 CFR Part 72. Public Health Service 42 CFR Part 72. Interstate Transportation of Etiologic Agents.Interstate Transportation of Etiologic Agents. http://www.cdc.gov/od/ohs/biosfty/shipregs.htmhttp://www.cdc.gov/od/ohs/biosfty/shipregs.htm

Department of Transportation. 49 DFR Parts Department of Transportation. 49 DFR Parts 171-180. Hazardous Materials Regulations. 171-180. Hazardous Materials Regulations. Applies to the shipment of both biological agents Applies to the shipment of both biological agents and clinical specimens.and clinical specimens. http://www.hazmat.dot.gov/rules.htmhttp://www.hazmat.dot.gov/rules.htm New regulations just establishedNew regulations just established

Regulations United States Postal Service. 39 CFR Part 111. United States Postal Service. 39 CFR Part 111.

Mail ability of Etiologic Agents.Mail ability of Etiologic Agents. From the From the Domestic Mail Manual 124.38Domestic Mail Manual 124.38 http://www.access.gpo.govhttp://www.access.gpo.gov

Occupational Health and Safety Occupational Health and Safety Administration (OSHA). 29 CFR Part 1910. Administration (OSHA). 29 CFR Part 1910. 1030. 1030. Provides minimal packaging and labeling Provides minimal packaging and labeling requirements for transport of blood and body requirements for transport of blood and body fluids within the laboratory and outside of it.fluids within the laboratory and outside of it. http://www.osha.govhttp://www.osha.gov

Regulations Dangerous Goods Regulations (DGR). Dangerous Goods Regulations (DGR).

International Air Transport Association International Air Transport Association (IATA). (IATA). These regulations followed by the These regulations followed by the airlines provide packaging and labeling airlines provide packaging and labeling requirements for infectious substances and requirements for infectious substances and materials as well as for diagnostic specimens.materials as well as for diagnostic specimens. http://www.iata.org/cargo/dg/http://www.iata.org/cargo/dg/

Guidelines for the Safe Transport of Infectious Guidelines for the Safe Transport of Infectious Substances and Diagnostic Specimens. Substances and Diagnostic Specimens. World World Health Organization (WHO), 1997.Health Organization (WHO), 1997. http://www.who.int/emc/biosafety.htmlhttp://www.who.int/emc/biosafety.html

Other Websites

CDC – Centers for Disease ControlCDC – Centers for Disease Control www.bt.cdc.govwww.bt.cdc.gov

ASM – American Society for MicrobiologyASM – American Society for Microbiology www.asmusa.orgwww.asmusa.org

Utah Department of Health (Microbiology)Utah Department of Health (Microbiology) www.health.utah.gov/els/microbiologywww.health.utah.gov/els/microbiology

Additional Comments Call ahead of timeCall ahead of time

Clinical/EnvironmentalClinical/Environmental Let lab know sample is on its wayLet lab know sample is on its way

Clinical SpecimensClinical Specimens Go to Level A Labs for rule-outGo to Level A Labs for rule-out

Environmental SpecimensEnvironmental Specimens Go to UDOH LabGo to UDOH Lab

UDOH has 24/7 coverageUDOH has 24/7 coverage

Contact Information Utah Department of Health Lab ResponseUtah Department of Health Lab Response

Kim ChristensenKim Christensen – 801-584-8449 – 801-584-8449 [email protected]@utah.gov

June PounderJune Pounder – 801-584-8449 – 801-584-8449 [email protected]@utah.gov

Barbara JepsonBarbara Jepson – – 801-884-8595 801-884-8595 [email protected]@utah.gov

Emergency Pager Emergency Pager – 801-241-1172– 801-241-1172

FBI - 801-579-1400FBI - 801-579-1400