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

Ebola Latest Information: OSDH PHL is NOW validated to test OSDH Acute Disease Epidemiology (405-271-4060, 24/7) must be contacted before sending samples for testing Ship specimens (whole blood 4 ml purple tops) on cold packs PHL (405-271-5070) will assist in guidance for transportation & packaging

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.

Where Do You Find the Shipping Regulations? Department of Transportation (DOT) 49 CFR 171-180 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 171-178) 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)

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.

Employers Provide appropriate materials for shipping specimens HMR 49 CFR 172.702-4; 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 172.704

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 171-180, IATA’s Dangerous Goods Regulations and USPS’s Domestic Mail Manual

Security Awareness Areas of Vulnerability 3 Ps Personnel Physical HMR 49 CFR 172.704 (a)(4); DGR 1.5 Areas of Vulnerability 3 Ps Personnel Physical Processes

Hazardous Materials/Dangerous Goods HMR 49 CFR 105.5 (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

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

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:

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

Shipping Categories HMR 49 CFR 173.134 (b)(10); DGR 3.3.6.2.2.3.6 Excepted from regulations (Courier-patient specimens only) Exempt Human Specimens (IATA) Notes: DGR 3.6.2.2.2, 3.6.2.2.3.6, 3.6.2.2.3.1 & 2 (IATA); HMR 49 CFR 173.134(a)(1)(i), 173.134(b)(1) (DOT);

Exempt Human Specimens DGR 3.3.6.2.2.3.6 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 3.6.2.2.3.6 IATA ONLY CATEGORY

Noninfectious- Commercial DGR 3.3.6.2.2.3.6 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 3.6.2.2.3.6

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?

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: 678-987-6543  Contact: Jo-Jo Exempt Blank box with To/From and exempt human specimen along with dry ice and only appropriate labels

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Shipping Categories Infectious substances: Category A Infectious substances: Category B Notes: Dangerous Goods Regulations 3.6.2.2.2, 3.6.2.2.3.6, 3.6.2.2.3.1 & 2 (IATA); 49 CFR 173.134(a)(1)(i), 173.134(b)(1) (DOT);

Category A HMR 49 CFR 173.134; DGR 3.6.2.2 “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- 3.6.2.2.2.1 in the DRG. DOT- 49 CFR 173.134(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.

Category A, Infectious Substance HMR 173.199; 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 173.199(a)(1). Primary receptacle volumetric capacity 1L when going by air per DOT 49 CFR 173.199(b)(5), USPS DMM 10.17.6 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 173.199(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.

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.

Dangerous Goods Form 1 1 Atlanta International Shipper Steve Johnson 405-406-3511 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 30333 404-255-1322 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

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

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 3.6.1.3) Emergency Telephone Number

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

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?

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?

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?

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?

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?

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: 405-406-3511  Contact: Johnny B Good Cat A labeled box with just labels needed for Cat A

Shipping Categories Infectious substances: Category B HMR 49 CFR 172.704 (a)(4); DGR 1.5 Infectious substances: Category B Notes: Dangerous Goods Regulations 3.6.2.2.2, 3.6.2.2.3.6, 3.6.2.2.3.1 & 2 (IATA); 49 CFR 173.134(a)(1)(i), 173.134(b)(1) (DOT);

Category B HMR 49 CFR 173.134 (a)(1)(ii); DGR 3.6.2.2.2.2 An infectious substance which does NOT meet the Category A criteria Infectious substances in Category B must be assigned to UN 3373 Notes: IATA- 3.6.2.2.2.2 in the DRG; DOT- 49 CFR 173.134(a)(1)(ii). IATA 3.6.2.1.3 refers to cultures prepared for the intentional generation of pathogens and does not include cultures intended for diagnostic and clinical purposes.

Biological Substance, Category B HMR 49 CFR 173.199 (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 173.199(a)(1). Primary receptacle volumetric capacity 1L when going by air per DOT 49 CFR 173.199(b)(5), USPS DMM 10.17.6 and IATA DGR PI 650. 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 173.199(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.

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?

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?

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 63140 Telephone: 555-222-4444 Contact: Lab Rat Cat B Blank box in state with just labels needed for outside and inside. No extras

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 172.201(e)) Dangerous good forms Packaging Documentation Package inserts Reference Material Books, Checklists, Labeled diagrams/boxes

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?

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: 405-406-3511  Contact: Johnny B Good Cat A with non-labeled box with all the labels for exempt, Cat B, Cat A

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?

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: 405-406-3511 Contact: Johnny B Good Cat A with non-labeled box with all the labels for exempt, Cat B, Cat A

http://www.phl.health.ok.gov QUESTIONS??? STEVE JOHNSON stevej@health.ok.gov 405-271-9444 EXT 57705 JOHN MURRAY johnfm@health.ok.gov 405-271-9444 EXT 57706 http://www.phl.health.ok.gov