View Category B-Biological Specimen Shipping Booklet
Contents
1. d Elmhurst Memorial lI W Reference Laboratory Shipping Biologic Specimens Shipping Specimens for Testing How Do I Ship Specimens For Laboratory Testing Packing instructions differ based on 1 potential hazard of specimens 2 transport temperature required and 3 volume of specimens you will ship Before you begin you must know these three things about your specimen shipment and be trained and certified in the appropriate hazmat shipping regulations Your employer is responsible for this training Before shipping biologic specimens please read this booklet for important specimen preparation packaging and shipping information Then follow the specific packing instructions included with the mailing kits provided Reading this booklet by itself does not constitute hazmat training or certification Potential Hazard The three hazard categories for specimens are Medical Biologic and Infectious e Medical Specimens are defined as clinical specimens in which any known or suspected pathogens have been inactivated or neutralized so that it cannot cause disease if exposure to it occurs Biopsied tissue in 10 formalin is an example of a Medical Specimen e Biologic Specimens are defined as any human or animal excreta secreta blood tissue or tissue fluid which may contain pathogens that can cause human or animal disease for which there are effective treatments and preventative measures available and the risk of spread2. If you do not know the stability requirements for a particular test please call client services at 331 221 4422 Priority Overnight Shipping EMHRL has contracted FedEx to deliver your specimens with Priority Overnight service to our facility by 9 00 am Central Standard Time CST If an ordered test has a specimen stability of 24 hours please remember the following time differences when scheduling specimen collection Collected before 7 00 am PST shipped the same day will be greater than 24 hours old Collected before 8 00 am MST shipped the same day will be greater than 24 hours old Collected before 9 00 am CST shipped the same day will be greater than 24 hours old Collected before 10 00 am EST shipped the same day will be greater than 24 hours old Keep in mind that your shipment may be delayed by severe weather conditions affecting air travel Also because FedEx does not deliver on Sundays specimens collected on Saturday may be over 48 hours old when received by the lab Saturday pickup or delivery must be authorized by your account representative Elmhurst Memorial Reference Laboratory Biologic Specimen Shipping page 4 Specimen Packaging Cold Packs If you are shipping refrigerated or frozen specimens freeze a cold pack at least 24 hrs before you ship FedEx Pickup 1 Call FedEx at 800 GOFEDEX to arrange a pick up for your shipment If possible schedule a regular pick up day time with your FedEx courier 2
3. gel pack Indicate pre shipment storage temperature on packing slip High Sensitivity CRP Specimen 1 ml of plasma drawn in PST light green vacutainer tube Mix well immediately after collection Centrifuge and refrigerate within 2 hours of collection Stability 48 hours refrigerated Transport Conditions Ship insulated with cold gel pack DO NOT FREEZE Indicate pre shipment storage temperature on packing slip HIV antibodies 1 amp 2 Specimen 1 ml serum drawn in SST gold top vacutainer Mix well immediately after collection and allow to clot for 15 30 minutes Centrifuge and refrigerate within 2 hours Stability 7 days refrigerated Transport Conditions Ship insulated with frozen gel pack Indicate pre shipment storage temperature on packing slip Lipid Panel Specimen 1 ml of plasma drawn in PST light green top vacutainer tube from a fasting patient Mix well immediately after collection Centrifuge and refrigerate within 2 hours Stability 48 hours refrigerated If transferred to plastic vial plasma stable 72 hours refrigerated and gt 72 hours if frozen Transport Conditions Ship insulated with frozen gel pack Indicate pre shipment storage temperature on packing slip CBC diff test orders on specimens received 24 hours after collection will be changed to hemogram only For specimens received 48 hours after collection the entire test order will be cancelled Elmhurst Memorial Reference La
4. of infection is limited Pathogens of this nature are also called Category B pathogens e Infectious Specimens are those known to contain or suspected of containing pathogens that when exposure to it occurs is capable of causing permanent disability life threatening or fatal disease to humans or animals Pathogens of this nature are also called Category A pathogens see Appendix Please call Client Services before sending highly infectious cultures or specimens from a patient that may have been exposed to a highly infectious agent Special packaging and handling is required for these types of specimens This booklet contains instructions for shipping Biologic Specimens ONLY Medical Specimens are not subject to these regulations and should NOT be transported as Biologic Specimens Biopsy mailing kits include instructions for shipping Medical Specimens If the specimens you are shipping do not meet requirements for a Biologic or Medical Specimen as defined above please call EMHRL for Infectious or other packing instructions Transport Temperature Use Appendix 2 to determine which mailing kit will provide the appropriate transport temperature and specimen capacity you will need for the type and number of specimens you are transporting Volume of Specimens to Ship The shipper must be large enough to hold ALL specimens you will be shipping in 1 24 hour period and must not exceed regulatory limits for total specimen volume weight Elm
5. 4 cups cold gel packs for Biologic specimens requiring refrigerated or refrig ambient transport conditions For biologic specimens requiring ambient room 15 vials swabs or 1 2 cups temperature transport conditions Combine refrigerated frozen and or ambient 50 75 vials and 1 4 cups room temperature specimens in one box Styrofoam cooler to accomodate dry ice or frozen Call Lab for sizes gel packs for frozen Biologic specimens serum 331 221 4422 or plasma in transfer vials For urine drug screen specimens Call Lab for sizes Chain of Custody available SOAS Ee For medical specimens in 10 formalin or 1 2 formalin cups Cytological preservative solution Elmhurst Memorial Reference Laboratory Biologic Specimen Shipping page 9 Appendix 3 Specimen Collection and Transport for Common Diagnostic Tests BMP CMP LDH Specimen 1 ml of plasma drawn in PST light green top vacutainer tube Mix well immediately after collection Centrifuge and refrigerate within 2 hours of collection Stability 48 hours refrigerated If transferred to plastic vial plasma is stable 72 hours refrigerated Transport Conditions Ship insulated with frozen gel pack Indicate pre shipment storage temperature on packing slip CBC with Differential Specimen 2 ml whole blood drawn in EDTA purple top vacutainer Mix well immediately after collection and make 2 blood smears on glass slides Allow slides to air dry Stability With slid
6. Do not put Biologic Specimen shipments in a FedEx drop box 3 Do not ship on Friday Saturday or on dates where arrival falls on a holiday unless prearranged with your account representative Mailing Kits and Packing Instructions Follow the specific packaging instructions included with your mailing kit Please use only the mailing kits supplied to you by EMHRL Do not use FedEx mailing boxes to ship biologic specimens Packing List A customized packing list is provided with each mailer Each box offered for shipping must contain a packing list Chain of custody specimens may use a shipping log in place of the packing list Please indicate the following on the packing list Shipping Date Type and number of specimens Total volume of specimens Storage temperature of the specimens before being packaged for shipment Signature of person responsible for packing the shipment FedEx Tracking number you can stick the top portion of the airbill to the packing list Dn nn FW NY Airbills for Priority Overnight Shipping Monday thru Thursday Shipments Automated Barcode Airbills Please use the automated airbill stickers provided in each mailing kit when shipping on Monday thru Thursday When you use these labels your shipment is automatically tracked upon pickup by the FedEx courier To use an automated airbill label peel off the upper portion of the airbill label and stick it to the packing list before sealing your shipm
7. boratory Biologic Specimen Shipping page 10
8. delivery Supplies can be shipped priority overnight for an additional charge see supply requisition for fees Additional Fees Recurring incidents of improper packaging may incur a 50 00 fine charged to your account Federal Stark laws prohibit us from providing supplies that are not used solely for the purpose of performing tests offered by EMHRL Elmhurst Memorial Reference Laboratory Biologic Specimen Shipping page 2 Test Requisitions Please print clearly all of the following required information on this test requisition Patient information Complete patient information in the box at the top of the requisition This information must match any corresponding information on the specimen label A social security number may be necessary for correlation with previous results but is not required Specimen collection Time and date of specimen collection Ordering physician Full name and UPIN NPI number if not on file with us Bill to Mark the box indicating bill to be sent to client patient medicare medicaid or insurance Patient billing Provide patient s complete name and billing address on lines 1 3 Medicare Medicaid or Insurance billing Provide the following on lines 1 5 Patient name and address Copy of the front and back of third party payer id card ICD 9 CM codes all that apply to patient Signature of physician and ordering date Storage and Transport Conditions Refrigerated Specimens Most sp
9. ecimens are refrigerated at 2 8 C while awaiting pick up however if you are unsure about the storage temperature for a particular specimen please check the storage and transport requirements in the test listing section of the Client User Manual at www emhreflab org or call Client Services at 331 221 4422 If you have any concerns regarding the effect of extremely warm weather conditions on refrigerated or frozen specimens during shipping please contact Client Services for instructions Ambient Specimens Ambient means room temperature and should not be packaged with refrigerated or frozen specimens If you have any concerns regarding the effect of extremely cold weather conditions on ambient specimens during shipping please contact Client Services at 331 221 4422 for instructions Frozen Specimens e Send the indicated number of frozen serum or plasma aliquots for each assay requested e Each plastic specimen vial should not be more than three fourths full e Never freeze a VACUTAINER tube e The specimens should be kept in the freezer whenever possible until the courier arrives Elmhurst Memorial Reference Laboratory Biologic Specimen Shipping page 3 Specimen Collection Test Requirements Specimens must be collected according to the test requirements as listed in the EMHRL Client Users Manual For your convenience the chart in Appendix 3 lists test requirements and stability conditions for some common tests If you do no
10. ent Attach the bottom portion of the airbill to the outer package Automated airbills expire 60 days after the print date Please discard expired airbills and call customer service 331 221 4422 to order new ones Friday Shipments Handwritten Paper Airbills Do not use the automated Barcode Airbills when shipping overnight on Fridays The delivery services embedded in the barcode do not authorize Saturday delivery so packages may be held at a FedEx location until Monday To ship on Friday please use the paper airbills we provide Write your customer account code in the Reference field of the airbill form Your account code appears on your packing list top line of the address info box Elmhurst Memorial Reference Laboratory Biologic Specimen Shipping page 5 Shipping Regulations for Biologic Specimens Definitions e Dangerous Goods Hazardous Materials identified by the US Department of Transportation e IATA International Air Transport Association e DOT Department of Transportation e 49CFR U S Code of Federal Regulations book Regulations The US Department of Transportation requires anyone who causes dangerous goods to be transported by public carrier to follow Dangerous Goods Shipping Regulations as stated in 49 CFR For air shipments IATA Dangerous Goods Regulations must also be followed The shipper is responsible for e Properly identifying the class and packing instruction of the hazardous material to be shipped e F
11. es 48 hours room temp or refrigerated Without slides 24 hours room temp or refrigerated Transport Conditions Ship at room temperature or insulated with cold gel pack DO NOT FREEZE Enclose slides in cardboard holder CBC Hemogram only Specimen 2 ml whole blood drawn in EDTA purple top vacutainer tube Mix well immediately after collection Stability 48 hours room temperature or refrigerated Transport Conditions Ship at room temperature or insulated with cold gel pack DO NOT FREEZE Glycohemoglobin A1C Specimen 4 ml whole blood drawn in EDTA purple top vacutainers Mix well immediately after collection Refrigerate in 2 hrs Stability 7 days refrigerated Transport Conditions Ship insulated with cold gel pack Indicate pre shipment storage temperature on packing slip TSH Specimen 2 ml serum drawn in SST gold top vacutainer Mix well immediately after collection and allow to clot for 15 30 minutes Centrifuge and refrigerate within 2 hours Stability 48 hours refrigerated Transport Conditions Ship insulated with frozen gel pack Indicate pre shipment storage temperature on packing slip Hepatitis HBsAG Anti HBcore Anti HCV Specimen 2 ml serum drawn in SST gold top vacutainer Mix well immediately after collection and allow to clot for 15 30 minutes Centrifuge and refrigerate within 2 hours Stability 5 days refrigerated Transport Conditions Ship insulated with frozen
12. hurst Memorial Reference Laboratory Biologic Specimen Shipping page 1 Shipping Fees and Policies Priority Overnight Shipping If you elect to use our express shipping service provided by FedEx to ship biologic specimens we will provide you with shipping materials and airbills A shipping surcharge will be applied to your account for each return airbill used We can customize your shipping supplies to fit your needs and minimize your shipping costs Contact Client Services at 331 221 4422 for details IMPORTANT Shipping packages on Friday requires authorization for Saturday delivery Fedex will hold unauthorized packages picked up on Friday for delivery on the following Monday To find out if you are authorized for Saturday delivery call your account representative Ordering Supplies ORDERING FORM See Shipping Client Supply Requisition for a list of supplies provided to your location free of charge Details about types of mailers available are in Appendix 2 Fill out the order form completely including your email address and study number if there is one Fax your order to Client Services 331 221 3735 SHIPMENT TRACKING An automatic email will notify you when your shipment is placed in transit You can use the tracking number and link in the email to track your shipment Another email will notify you when your shipment has been delivered DELIVERY TIME When ordering supplies please allow 7 business days for ground
13. igid material and able to close securely e Able to secure the secondary packaging against movement such that any leakage of the contents will not impair the protective properties of any cushioning material or the outer packaging e Able to withstand a drop of 4 feet without breakage of inner or outer packaging e Of sufficient size so that at least one dimension of the package measures no smaller than 4 x 4 Smaller packages may be shipped if placed in a FedEx Clinical Pak envelope e Total outer container volume weight capacity may not exceed 4L 1 gal or 4kg 8 8 Ibs Elmhurst Memorial Reference Laboratory Biologic Specimen Shipping page 6 Packing List Place an itemized packing list between the secondary and outer container stating e The Hazard name and number For example Biologic Specimens UN3373 e The number and type of specimens followed by total volume or weight e Name address and telephone number where the shipper may be contacted Markings on the Outer Package e Must be clearly and visibly marked with the words Biologic Specimen and the name address and phone number where the shipper can be reached Air shipments must be clearly and visibly marked with a UN3373 diamond label adjacent to the Biologic specimen label FedEx requires all Biologic Specimens to be packaged according to IATA air shipment regulations regardless of whether it is shipped ground or air Must NOT bear any other labels or marki
14. is to be retained on each employee performing hazmat shipping for the duration of his or her employment and for 90 days thereafter The information provided in this document does not meet the training requirements required by DOT 49 CFR Part 172 700 For more information on hazmat training contact the organizations in the resource listing below Resources International Air Transport Association IATA Dangerous Goods Regulations 2005 46 ed or call information hotline 514 390 6770 or go to www iata org whatwedo dangerous_goods Department of Transportation Hazardous Materials Info Line 1 800 467 4922 Also see Rules and Regulations Rulemakings and Federal Register Notices www hazmat dot gov FedEx Dangerous Goods Hazardous Material Hotline 800 463 3339 press 81 Also visit their website www fedex com us services options express dangerousgoods Elmhurst Memorial Reference Laboratory Biologic Specimen Shipping page 7 Appendix 1 Examples of INFECTIOUS SUBSTANCES DOT Risk Group 4 DO NOT SHIP Pathogens classified into this group MAY NOT be transported under Division 6 2 regulations for Biologic specimens Unless packaged according to IATA regulations for Infectious Substances Category A no person may knowingly transport any material known or suspected to contain one or more of the following etiologic agents notwithstanding new or emerging pathogens or pathogens not listed here that may be classified by the definition
15. ngs Do not use Biohazard labels on outer package OSHA requires a biohazard label on the specimen bag INSIDE the box but does not require a label on the outer box that is already labeled according to hazmat regulations Formalin Specimens containing 30 ml or less of 10 formalin are considered Medical Specimens and should NOT be labeled as Biologic Specimens UN3373 Dry Ice If your shipment requires dry ice the outer box must display the Class 9 label indicating the amount of dry ice contained in the shipment The package must also be vented to allow dry ice vapor to escape Training and Documentation Each person who offers or transports a Biologic specimen under the provisions of CFR 49 section 173 199 must know about the requirements of this section Training means a systematic program that ensures that a hazmat employee has familiarity with the general provisions of CFR 49 is able to recognize hazardous materials has knowledge of specific requirements applicable to functions performed by the employee and has knowledge of emergency response information and safety measures for accident and exposure prevention The shipping employer is responsible for providing and documenting appropriate hazmat training to employees who perform or cause to perform shipping functions No employee may perform shipping functions without initial training before any regulatory changes go into effect and at least once every 3 years Documentation
16. ollowing all packing instructions and regulations when offering a package for shipment e Training of employees who perform packaging functions for shipping hazardous materials e Maintaining records of employee hazmat training Hazard Classes The DOT divides all Dangerous Goods DGs into hazard classes based on the type of hazard Some hazard classes may also have several subdivisions In addition most DGs are assigned to one of three packing groups based on the degree of hazard they represent see Table 1 Packing Instructions The IATA has developed packing instructions for every hazardous substance shipped by air Federal law requires that these instructions be followed accurately Table 1 Hazard Classes Class 1 Explosives Class 5 Oxidizers and Organic Peroxides Division 1 3 Explosives Division 5 1 Oxidizers Division 1 4 Explosives Division 5 2 Organic Peroxides Class 2 Gases Class 6 Toxic Poisons and Infectious Substances Division 2 1 Flammable Division 6 1 Toxic Substances Division 2 2 Non Flammable Non Toxic Division 6 2 Infectious Substances Division 2 3 Toxic A Infectious Specimens B An Class 3 Flammable Liquids Class 7 Radioactive Substances Class 4 Flammable Solids Division 4 1 Flammable Class 8 Corrosives Division 4 2 Spontaneously combustible Division 4 3 Dangerous when wet Class 9 Miscellaneous Dangerous Goods Dry ice is in this class and 10 Formalin Outer Packaging must be e Constructed of r
17. s of Risk Group 4 Bacterial Agents Acinetobacter calcoaceticus Actinobacilus Actinomycetaceae Aeromonal hydrophila Arachnia propionica Edwarsiella tarda Ersipelothrix insidiosa Haemophilus decreyi Haemophilus influenzae Legionella all species Legionella like organisms Leptospira interrogans Mima polymorpha Neisseria gonorrhoeae Neisseria meningitidis Nocardia asteroides Plesiomonas shigelloides Sphaerophorus necrophorus Treponema careteum T pallidum T pertenue Cultures only Arizona hinshawii Bacillus antracis Bacteroides Bartonella Bordetella Borrelia recurrentis vincenti Brucella Campylobacter Vibrio fetus Campylobacter Vibrio jejuni Chlamydia psittaci Clostridium botulinum chauvoei haemolyticum histolyticum novyi septicum tetani Corynebacterium diphtheriae equi haemolyticum pseudotuberculosis pyogenes renale Escherichia coli enteropathogenic serotypes Francisella tularensis Klebsiella Listeria Moraxella Mycoplasma Pasteurella Proteus Pseudomonas mallei P pseudomallei Salmonella Shigella Staphylococcus aureus Streptobacillus moniliformis Streptococcus pneumoniae Streptococcus pyogenes Vibrio cholerae parahaemolyticus Yersinia pestis enterocolitica Fungal Agents Blastomyces dermatitidis Paracoccidioides brasiliensis Cultures only Coccidiodes immitis Cryptococcus neoformans Histoplasma capsulatum Mycobacterium Viral and Rickettsial Agents Cre
18. t know the collection requirements for a particular test please call client services at 331 221 4422 Specimen Labeling Specimen labels must contain patient name as written on test order date of birth and collection date amp time Labeling on aliquot tubes should also include specimen type plasma serum urine etc Transfer Tubes If specimen aliquoting is required or desired for batching use transfer vials provided by EMHRL Aliquoting is not necessary for whole blood or gel separated specimens drawn in vacutainer tubes unless specified in test requirements However aliquoting is recommended because it often extends the stability of serum and plasma Whether using transfer tubes or not please make sure all specimens are capped firmly before shipping Specimen Stability Specimen stability depends on the test type of specimen and storage transport conditions To ensure that your specimen will be viable for testing it must be collected processed stored and packed according to the specific requirements listed in your Users Manual and mailing kit instructions For greatest stability it is preferable to freeze all non ambient serum or plasma specimens in aliqout tubes for at least 24 hrs in your coldest freezer until you are ready to ship unless test requirements prohibit freezing Do not freeze whole blood specimens When freezing it is imperative to leave air space at the top of the tube to allow for expansion of liquid specimen
19. utzfeldt Jakob agent Cytomegaloviruses Ebola virus Echoviruses Encephalomyocarditis virus Flexal virus Hantaan virus Hendra virus Hemorhragic fever agents Guanarito virus Junin virus Kuru agent Kyasanur Forest virus Lassa virus Lymphocytic choriomeningitis virus Machupo virus Marburg virus Monkeypox virus Nipah virus Rabies virus Reoviruses Sabia virus Simian virus 40 Variola viruses Whitepox viruses Cultures only Adenovirus human Arboviruses Avian influenza virus Coxiella burnetii Coxsackie A and B Dengue viruses Equine encephalitis virus Hepatitis viruses Herpes virus Human immunodeficiency virus Infectious bronchitis like virus Influenza viruses Japanese encephalitis virus Measles virus Polioviruses Parainfluenza Poxviruses Respiratory syncytial virus Rhinoviruses Rickettsia virus Rotaviruses Rubella virus Tick borne encephalitis virus Vaccinia virus Varicella virus Vesicular stomatis viruses West Nile virus Yellow fever virus Elmhurst Memorial Reference Laboratory Biologic Specimen Shipping page 8 Appendix 2 Mailing Kits Available KIT COLD COLD COMBO ROOM TEMP COMBO COOLER DRY ICE COOLER DRUG SCREEN BIOPSY SPECIMEN TYPE CAPACITY Air transport bag insulated envelope and cold 15 vials or 1 cup gel pack for Biologic specimens requiring refrigerated transport conditions Air transport bags 2 insulated envelopes and 40 vials or
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