DOT Special Permit Category A Erin Bowles, BS, MT(ASCP) Wisconsin Crystal Fortune, BSCLS,MLS (ASCP) Montana Karen Stiles, MT(ASCP)SM CM Nebraska Lisa Wallace, BS, West Virginia 1
Category A Special Permit Objectives: Upon completion of this session, the participant will be able to: 1. Discuss reasons why applying for a DOT special permit is necessary for high consequence pathogens Category A Packaging & Shipping exercises 2. Describe the process for applying to be party to a special permit 2
History of our project Special Thanks to Rob Nickla, Schoola Escott, Sue Riley, Chris Mangle, Amy Pullman High suspicion that sentinel clinical labs do not package Category A specimens correctly Need to be able to conduct an exercise Need the exercise to be as close to sending a real specimen as possible No legal way to conduct an exercise Illegal to send empty tubes or non-Category A specimens as a Category A specimen Illegal to put a Category A labeled box inside another box not marked as a Category A – this is an overpack Aware of a Category B special permit, but no Category A special permit Had an initial call with DOT to discuss the need for states to be able to conduct Category A packaging and shipping exercise Was there a simple way to do this without getting a special permit? 3
Purpose Statement for Special Permit 1. Allow state and local governmental public health laboratories to initiate their own Category A infectious substance packaging and shipping drill with clinical laboratories in their jurisdiction. 2. Realistic Category A drills are essential for determining laboratory’s competency in packaging and shipping specimens 3. The demonstration of laboratory competency in the packaging and shipping of Category A infectious substances ensures the safety of everyone including the packager, those who handle the packages during transport, the recipient and the general public. 4
C ontrols to conduct a Category A Infectious Substance Drill: 1. State or local CDC LRN-B reference laboratory member [ APHL and/or CDC can verify membership by providing a list to DOT ] 2. Valid Certificate of Compliance or Accreditation in accordance with CLIA or a CLIA- approved accreditation agency such as CAP or The Joint Commission. 3. Conduct the drill with laboratories that reside within their jurisdiction/state. 5
C ontrols for Sentinel labs to participate in a Category A Infectious Substance Drill: 1. All laboratories participating in the packaging and shipping drill must have a valid CLIA certificate and be inspected regularly by a CMS/CLIA State Agency or a CLIA- approved accreditation agency such as CAP or The Joint Commission. 2. The participating shipping laboratory is responsible for ensuring they have personnel certified to package Division 6.2 Category A Infectious Substances at their facility. Only personnel with current certification records may participate in this drill. 3. The participating laboratories must be within the initiating facility’s jurisdiction/state. 6
LRN-B laboratories have two drill scenarios available to challenge the laboratories within their jurisdiction. Scenario 1: 1. Conducted in conjunction with an bioterrorism preparedness exercise. 2. Ship at least one suspect culture packaged as a Category A infectious substance following all DOT and IATA packaging and shipping requirements. Scenario 2: 1. Transporting a possible high consequence pathogen such as Ebola. 2. Ship at least one empty sample collection container, packaged as a Category A infectious substance following all DOT and IATA packaging and shipping requirements. 7
8 Appendix B
9 Appendix C
Evaluation 1. Participating shipping laboratories will be evaluated on proper packaging, marking, and documentation. 2. All participating shipping laboratories will be critiqued by their state or local public health LRN-B reference laboratory using the attached checklist. For more information, refer to Appendix A (share drive), Checklist for Evaluating Category A Packaging and Shipping Drill. 3. The state or local public health LRN-B reference laboratory will provide each participating laboratory with an individual report detailing errors that were made and providing corrective information. 4. Cumulative data from the drill will be used to enhance future trainings in packaging and shipping . 10
11 Appendix A
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13 Initial Party Application
14 Excerpt from Initial Application
What was provided in initial application 1. Table of Contents 2. Applicant Name/Address 3. Point of Contact 4. Ranking Officer 5. Dunn & Brad Number 6. Description of Special Permit proposal, including scenarios 7. Citation of specific regulation from which were seeking relief 8. Proposed mode of transport 9. Duration 10.Identification & description of hazardous materials planned for transport 11.Package description 12.Justification 13.Identification of Increased Risk 14.Risk Mitigation 15.List of known locations to participate in exercise 15
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17 First Sign of Permit Approval
FAA Inspection 1. Announced inspection 2. Reviewed Training Program 3. Reviewed Training Certificates 4. Inspected examples of shipping materials to be used in drills 5. Inspected Special Permit labels to be added to Cat A boxes 6. Required copy of the Special Permit to be attached to the shipper’s declaration (as well as number on the declaration) 7. Suggested plan to confirmation that boxes used for special permit would not accidently be placed into laboratory inventory 8. Emphasized all parties MUST be aware of the costs/fines involved if utilized outside of the scope of purpose 18
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21 Label Template – Avery 5160
Emergency Contact Specific to Permit PHL must provide emergency contact Types of Emergency Contact at Public Health Laboratories 1. Third Party Provider 2. Lab/Personal Must be available 24/7 Entire time exercise in transport Must be answered by person Knowledgeable of the Special Permit Conditions 22
23 Steps to become “Party To”
24 Steps to become “Party To”
25 Special Permit XXXX Shipper’s Declaration
Tool Box on Share Point 1. Party To Application 2. Application Template 3. Special Permit Agent contact information 4. Label Templates 5. Drill scenarios 6. Appendix A – Checklist for evaluating Category A Packaging/Shipping Drills 7. Appendix B - Instructions for Participating Shipping Laboratories (Ebola Scenario) 8. Appendix C - Instructions for Participating Shipping Laboratories (Agents of Bioterrorism Preparedness Scenario) 26
Important Points of Special Permit 1. Can NOT apply for Party To, until the official permit released 2. Can NOT modify scenarios 3. Have plan in place for special permit Emergency Contact at PHL 4. Work with designated DOT personnel when applying Andrew Eckenrode Transportation Specialist Email: andrew.eckenrode@dot.gov 5. Have plan in place to verify boxes with special permits are NOT mixed with routine shipping inventory (immediately cover labels at PHL?) 6. Notify your local courier of special permit process, prior to exercise 7. Document Special Permit number on Shipper’s Declaration 8. Required copy of the Special Permit to be attached to the shipper’s declaration (as well as number on the declaration) 9. **MOST IMPORTANT** Be aware that HazMat Teams will be called in, at great expense, if the exercise is not correctly handled 27
28 Packaging & Shipping Questions???? Division 6.2
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