1. Oklahoma State Department of Health Public Health Laboratory
Shipping and Packaging Laboratory Specimens Training 2016

2. Ebola Latest Information: OSDH PHL is NOW validated to test
OSDH Acute Disease Epidemiology ( , 24/7) must be contacted before sending samples for testing
Ship specimens (whole blood 4 ml purple tops) on cold packs
PHL ( ) will assist in guidance for transportation & packaging

3. Packaging Exercise
Package a blood sample from a suspected Ebola patient
This is an “ALL” scenario. Packet includes all possible labels and a labeled box.

4. Where Do You Find the Shipping Regulations?
Department of Transportation (DOT)
49 CFR Hazardous Materials Regulations (HMR)
Int’l Air Transport Association (IATA)
Dangerous Goods Regulations (DGR)
Center for Disease Control (CDC)
42 CFR Part 72 & 73 Select Agent Regulations
Select Agents of Bioterrorism
Notes: DOT (49 CFR Parts ) Hazardous Materials Regulations; USPS (39 CFR Part 111), Domestic Mail Manual (DMM) CO23 Hazardous Materials; IATA Dangerous Goods Regulations; CDC (42 CFR Part 72-73)

5. The Shipper is responsible!!
Ensure all information is accurate, legible and easy to identify
Ensure the shipment is prepared in accordance with the regulations
Who is the shipper?
Notes: The shipper is always responsible for the shipment until it reaches the intended recipient. The shipper must comply with the regulations. The shipper must ensure the appropriate forms are signed, monitor the shipment while in transit and provide the 24/7 number of a person who can deal with emergencies in transit.

6. Employers Provide appropriate materials for shipping specimens
HMR 49 CFR ; DGR 1.5
Provide appropriate materials for shipping specimens
Provide 24/7 emergency notification
Initial Training provided before employees perform shipping duties and must include:
General awareness- hazardous material handling
Function specific
Safety Training (OSHA)
Security Awareness
Record keeping
Notes: The employer is the Shipper and the Shipper is ALWAYS responsible.
HMR 49 CFR

7. Employee Responsibilities
HMR 49 CFR 704; DGR 1.5
Understand the Regulations
Successfully complete training
Apply the regulations as needed
Select the right category
Package and label
Complete all Paperwork
Notes: DOT’s 49 CFR , IATA’s Dangerous Goods Regulations and USPS’s Domestic Mail Manual

8. Security Awareness Areas of Vulnerability 3 Ps Personnel Physical
HMR 49 CFR (a)(4); DGR 1.5
Areas of Vulnerability
3 Ps
Personnel
Physical
Processes

9. Hazardous Materials/Dangerous Goods
HMR 49 CFR (b)(3); DGR 1.0
Definition: An article, substance or material that is capable of posing an unreasonable risk to health, safety and property when transported in commerce,….
Notes: 49 CFR 105.5

10. Hazardous Materials Nine Classes Class 6.0- Poisons
HMR 49 CFR 173.2; DGR 3.0
Nine Classes
Class 6.0- Poisons
6.2 – Infectious Substances
Class 9.0- MISCELLANEOUS MATERIALS
Dry Ice
Notes: There are 9 classes of hazardous materials that are regulated by government and non-government agencies. Class 6 and 9 directly pertain to the packaging and shipment of laboratory specimens.
HMR- 49 CFR 173.2

11. CDC Requirements Select Agents Chemical Terrorism/Accidents
Category A Shipping
Contact PHL Before shipping
Chain-of-Custody
Chemical Terrorism/Accidents
Contact PHL for assistance
Victim’s direct specimens must be packaged as a Category B, Biological Substance.
Notes:

12. Shipping Decision Tree
Category A? B? Exempt Human Specimen? Excepted?
Air?
Ground?
FedEx, UPS
USPS
Courier
FedEx, UPS
USPS

13. Shipping Categories
HMR 49 CFR (b)(10); DGR
Excepted from regulations (Courier-patient specimens only)
Exempt Human Specimens (IATA)
Notes: DGR , , & 2 (IATA);
HMR 49 CFR (a)(1)(i), (b)(1) (DOT);

14. Exempt Human Specimens
DGR
Patient specimens for which there is minimal likelihood that pathogens are present, are not subject to these (hazardous materials or dangerous goods) regulations
Notes: IATA DGR
IATA ONLY CATEGORY

15. Noninfectious- Commercial
DGR
EXEMPT HUMAN SPECIMENS (Air Only)
Primary
‪ □ Sealed and leak-proof (consider shipping in pressure tested primary or secondary, if by air)
‪ □ Wrapped in cushioning material
Secondary
‪ □ Absorbent material between the primary and secondary packaging
‪ □ Leak-proof
Outer Package
□ Test requisition/itemized list is placed BETWEEN
secondary and outer package
‪ □ Outer container with adequate strength
‪ □ One surface with minimum dimension of 100mm X 100mm
Over-pack
‪ □ Mark over-pack
‪ □ Repeat all markings from outer packs
Outer Package Labeling
‪ □ Shipper’s complete address
‪ □ Consignee’s complete mailing address
‪ □ Exempt Human Specimen
To:
From:
Exempt Human Specimen
Notes:
IATA DGR

16. Where should the requisition/manifest
Review
You are triple packing a non-infectious shipment for overnight shipping to an out-of-state reference lab.
Where should the requisition/manifest
be placed?

17. Scenario 1
A urine has been collected on a client at your clinic site. The sample is going to be sent to your reference laboratory in California for testing. The sample is to get there overnight. The sample must be frozen during transport.
 Address:
Cloudy Chance Laboratory
3333 North Vegas Street
San Diego, CA 70000
 Phone:
 Contact:
Jo-Jo
Exempt Blank box with To/From and exempt human specimen along with dry ice and only appropriate labels

18. Break

19. Shipping Categories Infectious substances: Category A
Infectious substances: Category B
Notes: Dangerous Goods Regulations , , & 2 (IATA); 49 CFR (a)(1)(i), (b)(1) (DOT);

20. Category A HMR 49 CFR ; DGR
“An infectious substance which is transported in a form that, when exposure occurs, is capable of causing permanent disability, life-threatening or fatal disease in otherwise healthy humans or animals.”
Proper shipping name is UN 2814, Infectious Substance, Affecting Humans, or UN 2900, Infectious Substance, Affecting Animals
Notes: Category A definition slightly varies from IATA to DOT version. IATA in the DRG. DOT- 49 CFR (a)(1)(i).
Full list of “Indicative examples of substances that meet these criteria”, are given in table 3.6.D of IATA’s DRG.

21. Category A, Infectious Substance
HMR ; DGR 5.6, PI 620
Primary
‪ □ Sealed and leak-proof (pressure tested primary or secondary container)
‪ □ Biohazard symbol (primary or secondary)
‪ □ Wrapped in cushioning material
‪ □ <1000ml (only 50ml on passenger plane)
Secondary
‪ □ Absorbent material between the primary and secondary packaging
‪ □ Leak-proof (pressure tested primary or secondary container)
Outer Package
□ Test requisition/itemized list is placed BETWEEN secondary and outer package
‪ □ UN Class 6.2 certified container kit
‪ □ <4000ml
‪ □ Include dangerous goods form(s) on outside of outer package
Overpack
‪ □ Mark “OVERPACK”
‪ □ Repeat all markings from outer packs
Package Labeling
‪ □ Shipper’s and consignee’s complete mailing address
‪ □ Infectious substance, affecting humans, UN 2814, # of ml,
‪ □ 24/7 emergency contact number,
‪ □ Class 6 infectious substance label
Notes: 49 CFR (a)(1). Primary receptacle volumetric capacity 1L when going by air per DOT 49 CFR (b)(5), USPS DMM and IATA DGR. For air shipments, either the primary or secondary receptacle must be capable of withstanding, without leaking, an internal pressure producing a pressure differential of not less than 95 kPa per DOT 49 CFR (b)(4). Check with the manufacturer.
4kg is the maximum amount for a solid, primary or outer container. If solids can liquify, then paragraph b of this section applies.
Outer packaging volume restrictions does NOT include ice, dry ice or liquid nitrogen per IATA.
Enough absorbent must be placed between the primary and the secondary receptacles to absorb the total volume of the primary. Prevent contact between primary receptacle when shipping multiple primaries in a single secondary package.

22. Category A, Infectious Substance
Packaging, marking, labeling and documentation requirements are SAME regardless of method of transportation.
Notes: All specimens containing a Category A or Suspected Category A substance MUST be packaged in a UN 6.2 approved container and all applicable regulations will be followed. Does not matter if going courier, USPS, FedEx, Ground or Air.
DNA Transfer, Inc.
Go-Bug, Inc.

23. Dangerous Goods Form 1 1 Atlanta International
Shipper
Steve Johnson
Oklahoma State Department of Health
1000 NE 10th St.
OKC, OK 73117 1 1
Dr. Joe Smith
Center for Disease Control
Data and Specimen Handling Sect
1600 Clifton Rd., NE Bldg 4
Atlanta, GA
Notes: Be sure to include the Consignee’s telephone number, which is required by your courier.
Instead of marking the selection you want, i.e. non-radioactice, you cross-out the selection you DON”T want.
Will Rogers Int’l-OKC
Atlanta International

24. Infectious Substance(s), Affecting Humans 6.2 4 tubes x 5ml
UN 2814
Infectious Substance(s), Affecting Humans
6.2
4 tubes x 5ml
Total Volume = 20ml
620
(suspected Category A, infectious substance)
All packed in 1 fibreboard box
Overpack Used
Notes: Proper Shipping Name (PSN)- If substance affects both humans and animals, its Proper Shipping Name (PSN) is’ “Infectious Substance, affecting humans”, even if it is primarily known as an animal disease. The word ‘Substance’ in the PSN can appear in its singular or plural form. The name of the material must appear below the PSN, in parenthesis, if known. If unknown write “Suspect Category A” below PSN. Class- is the hazardous material class (and division if applicable) the material falls in. UN or ID No.- a six digit code corresponding to particular hazardous material (UN 2814 is infectious substances, affecting humans; UN 2900 is infectious substances, affecting animals; UN 3373 is Category B, Infectious Substance). Packing Group- indicates the degree of hazard within some packing groups (I=great danger; II=moderate danger; III=minor danger). Quantity and Type of Packaging- number of and volume of primary containers. Be sure to also list that “All packed in 1 fibreboard box (some carriers will not accept if not spelled, ‘fibreboard’). Include, “Overpack used”, when appropriate. Packing Instructions- List appropriate packing instructions (PI) such as 620 for infectious substances.
Emergency Telephone Number

25. Infectious Substance(s), affecting humans
UN 2814
Infectious Substance(s), affecting humans
(suspected Category A, Infectious substance)
6.2
4 tubes x 5ml
Total Volume = 20ml
620
UN 1845
Dry Ice 9
III
3kg
924
All packed in 1 fibreboard box
Overpack Used
Notes: Quantity listed should be Dry Ice only, no packaging weight.
Dry Ice is a Packing Group III because it is a RELATIVELY LOW toxicity risk. Allocated to Packing Groups based on the degree of their toxic hazards in transport. (IATA DGR )
Emergency Telephone Number

26. Your Name Your Name and Title Oklahoma City, OK 2/26/09
Notes: Additional Handling Information- Emergency telephone number is required here.
Your Name
Emergency telephone number

30. Review
48 hours after the wreck an innocent bystander dies due to an exposure from an infectious substance in this accident.
What shipping category should this infectious
substance have been labeled?

31. What do these 2 labels convey to a hazmat team?
Review
The courier has a bad wreck while transporting specimens to the PHL. Containers are strewn all over the road, some are leaking. Hazmat arrives and identifies under a biohazard symbol and a on the box . 6 9
What do these 2 labels convey to a hazmat team?

32. What shipping category does the PHL require this be packaged as?
Review
You are unable to rule-out the presence of a Tier 1 select agent during testing. You call the PHL to report this. They immediately dispatch their courier on an emergency run. You are sending them a blood bottle.
What shipping category does the PHL require this be packaged as?

33. Review
You are shipping a suspect Category A specimen to your reference lab, overnight.
How many copies of the dangerous goods form are included on the outside of the box?

34. Review
You are preparing an unknown infectious substance to be shipped for identification by your PHL.
How will you describe this infectious substance, affecting humans, in the proper shipping name column of the dangerous goods form?

35. Scenario 2
Your laboratory has isolated a suspected case of Plague. You are required to send it to the LRN (Laboratory Response Network) Laboratory in your state. You are sending the isolate on a chocolate agar slant. An emergency courier has been dispatched to your laboratory to be there in 30 minutes. Include your chain-of-custody.
 Address:
LRN Lab
First and Second Street
Wherever, OK 33333
 Phone:
 Contact:
Johnny B Good
Cat A labeled box with just labels needed for Cat A

36. Shipping Categories Infectious substances: Category B
HMR 49 CFR (a)(4); DGR 1.5
Infectious substances: Category B
Notes: Dangerous Goods Regulations , , & 2 (IATA); 49 CFR (a)(1)(i), (b)(1) (DOT);

37. Category B
HMR 49 CFR (a)(1)(ii); DGR
An infectious substance which does NOT meet the Category A criteria
Infectious substances in Category B must be assigned to UN 3373
Notes: IATA in the DRG; DOT- 49 CFR (a)(1)(ii).
IATA refers to cultures prepared for the intentional generation of pathogens and does not include cultures intended for diagnostic and clinical purposes.

38. Biological Substance, Category B
HMR 49 CFR (a); DGR 5.6, PI 650
Primary
‪ □ Sealed and leak-proof (pressure tested if secondary is not and is being shipped by air)
‪ □ Biohazard symbol (primary or secondary container; secondary for USPS)
‪ □ Wrapped in cushioning material
‪ □ <1000ml
Secondary
‪ □ Absorbent material between the primary and secondary packaging
‪ □ Leak-proof (pressure tested if primary is not and is being shipped by air)
Outer Package
‪ □ Test requisition/itemized list is placed BETWEEN secondary and outer package
□ Rigid outer container with adequate strength
‪ □ < 4000ml ‪
Over-pack
‪ □ Mark over-pack
‪ □ Repeat all markings from outer packs
Package Labeling
‪ □ Shipper’s complete address
‪ □ Consignee’s complete address
‪ □ Biological Substance, Category B
‪ □ UN 3373 label
‪ □ 24/7Emergency contact information
Notes: 49 CFR (a)(1). Primary receptacle volumetric capacity 1L when going by air per DOT 49 CFR (b)(5), USPS DMM and IATA DGR PI For air shipments, either the primary or secondary receptacle must be capable of withstanding, without leaking, an internal pressure producing a pressure differential of not less than 95 kPa per DOT 49 CFR (b)(4). Check with the manufacturer.
4kg is the maximum amount for a solid, primary or outer container. If solids can liquify, then paragraph b of this section applies.
Outer packaging volume restrictions does NOT include ice, dry ice or liquid nitrogen per IATA.
Enough absorbent must be placed between the primary and the secondary receptacles to absorb the total volume of the primary. Prevent contact between primary receptacle when shipping multiple primaries in a single secondary package.

39. What infectious substance shipping label should be used?
Review
A fedex employee develops symptoms 24 hours after exposure to a damaged laboratory specimen box as he was loading an aircraft. He is treated with antibiotics and quickly recovers.
What infectious substance shipping label should be used?

40. Where do you place dry ice on the dangerous goods form?
Review
You are shipping a suspected chemical terrorism victim’s urine on dry ice to CDC.
Where do you place dry ice on the dangerous goods form?

41. Scenario 3
A Salmonella sp. grew from a stool culture and due to reporting requirements you are sending it on a slant to your state public health laboratory for grouping.
Address:
Your PHL
Any Street
Hometown, State
Telephone:
Contact:
Lab Rat
Cat B Blank box in state with just labels needed for outside and inside. No extras

42. Documentation
Training records (maintain through employment and 90 days after) required:
Employee’s name
Training date (renew every 2 yrs per IATA and 3yrs per DOT)
Description or copy of training materials
Name and address of person providing training
Completion of training and certifying documentation
Shipping Documentation- maintain for 2 years (49 CFR (e))
Dangerous good forms
Packaging Documentation
Package inserts
Reference Material
Books, Checklists, Labeled diagrams/boxes

43. What shipping category was this box?
Review
Your lab is visited again by the FAA because a non-Category A package they randomly selected to audit did NOT have a 24/7 number on the outside of the box.
What shipping category was this box?

44. Scenario 4
Your laboratory has isolated a suspected Francisella species. You are required to send it to the LRN (Laboratory Response Network) Laboratory in your state. You are sending the isolate on a chocolate agar slant. An emergency courier has been dispatched to your laboratory to be there in 30 minutes. Fill out the DGF and include your chain-of-custody.
 Address:
LRN Lab
First and Second Street
Wherever, OK 33333
 Phone:
 Contact:
Johnny B Good
Cat A with non-labeled box with all the labels for exempt, Cat B, Cat A

45. Ebola Virus Disease (EVD)
Have you performed a risk assessment for handling a PUI’s specimens?
Do you have a packaging plan?
Do you have a specimen container decon plan?
Do you have shipping containers?
Do you have a transportation plan?
Do you have certified shipping personnel available during all shifts?

46. Scenario 5
Please package a sample that has been collected from a patient suspected of having Ebola. Sample is going to the PHL (LRN Lab). Transport sample cold.
Address:
OSDH PHL
1000 NE 10th Street
OKC, OK 73117
Phone:
Contact:
Johnny B Good
Cat A with non-labeled box with all the labels for exempt, Cat B, Cat A

47. http://www.phl.health.ok.gov QUESTIONS??? STEVE JOHNSON
EXT 57705
JOHN MURRAY
EXT 57706