Transporting Biological Materials Training UCCBB

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1 Transporting Biological Materials Training UCCBB Histocompatibility Clinical Immunology University of Colorado Cord Blood Bank Stem Cell Laboratory Flow Cytometry

2 Objectives: In this course you will learn: Requirements for personnel training Different regulating agencies Proper Packing Requirements for Diagnostic and HPC without infectious disease testing Personal Safety HIPAA and Confidentiality

3 Personnel Training All employees handling Hazardous Materials/Dangerous Goods in any part of the shipping process must be trained. This includes those persons who: perform pre-transportation functions, such as preparing paperwork and/or packages, determining the hazard class of a hazardous material, selecting a hazardous materials packaging, or filling a hazardous materials package offer for transportation any hazardous materials or dangerous goods work in shipping, receiving or material handling areas or loads, unloads, or handles hazardous materials or dangerous goods marks, or otherwise represents packaging as qualified for use in the transportation of hazmat operates a vehicle used to transport hazmat If you are preparing the packages, paperwork or otherwise participating in shipping of hazardous materials, you are a HazMat employee.

4 Personnel Training Hazmat training must include: General awareness/familiarization, Function-specific training, Safety and security training, and Driver training (for each hazmat employee who will operate a motor vehicle). Following this training will insure the integrity of the Cord Blood unit potency and the health and safety of collection facility, transport staff, and processing personnel.

5 Personnel Training How Often Must Training Occur? Initial training: Is to be completed within 90 days of employment or change in job function. any new employee, or an employee who changes job functions, may perform hazmat job functions before completing training, provided the employee does so under the direct supervision of a properly trained and knowledgeable hazmat employee. Recurrent training: per U.S. DOT, for ground shipments is required at least once every three years. The three year period begins on the actual date of training.

6 Regulating Agencies DOT - Dept. of Transportation IATA - International Air Transport Association USPS - United States Postal Service OSHA - Occupational Safety and Health Administration DOC - Dept. of Commerce CDC - Centers for Disease Control and Prevention USDA - United States Dept. of Agriculture FDA - Food and Drug Administration

7 General Packing Requirements When picking up or packing for shipment, the transport container must consist of these components: a primary receptacle an absorbent packing material a secondary packaging; and an approved rigid outer packaging with temperature monitoring between the secondary and outer container Packaging must be constructed and closed as to prevent any loss of contents that might be caused under normal conditions of transport, by vibration, or by changes in temperature, humidity or pressure.

8 Proper packing Specimens of blood or other potentially infectious materials shall be placed in a container which prevents leakage during collection, handling, processing, storage, transport, or shipping. Cord blood products being transported to ClinImmune Labs should be placed in an approved rigid outer container that is labeled with biohazard stickers and includes DOT and FDA required labeling including contact numbers.

9 Proper packing specific to Cord Blood transport Trained staff will remove CBU from the green cooler and pack the approved rigid outer shipping container with temperature monitoring, 5 TCP Phase 22 Packs, and CBUs for transport.

10 Materials and Documentation Specific to Proper Packing of Cord Blood TCP Shipping Container (23 x 13 x 14 inches) = approved rigid outer shipping container with temperature monitoring. TCP phase change material packs validated to maintain proper transport temperature. Big Digit Min Max Thermometer for recording the temperature during transport. The cord blood staff or courier will complete the top section of Form B7.201 Collection and Shipping Log including. Courier/Shipping Technician: Initial the Verified By column to confirm each CBU and accompanying paperwork are (SM ) placed in the shipping container.

11 Materials and Documentation Specific to Proper Packing of Cord Blood The courier or CB staff will complete the top section of Form B7.201 Collection and Shipping Log including: Temperatures: (Expected 15 C 25 C / 59 F 77 F) Storage Thermometer Serial Number: Exp. Date: Cord Blood Storage Area: MIN: MAX: Current: Shipping Date: Pickup By: Pickup Time: Record serial number and expiration date(see back of thermometer). Record Min, Max, and Current temperature and reset the green storage container thermometer. Record shipping date of transport, your name under pickup by and record the time of pickup. Before initialing verified by, if both paperwork and blood are not present, document on B7.201 that it is missing.

12 Initial Here

13 Personal Safety Wear gloves for your own protection whenever handling samples that are not in a primary and secondary container -follow Universal (Standard) Precautions In the event of a product secondary container breach/accident or any delay in transport, please contact ClinImmune Labs or your supervisor

14 Personal Safety cont In the event you are involved in a motor vehicle accident: You should call for emergency assistance if needed Let the emergency response team know that you are transporting potential biohazards Notify your supervisor to contact the shipper and recipient of the sample status Arrange for alternate transportation if you are not able to get to your destination

15 Proper Packaging Labeling The outside of the shipping container must be labeled as follows: Biohazard Human cord blood for transplantation. The name of the collection facility, address and phone contact number. The name of the receiving facility, address and phone contact number. Keep Upright DO NOT IRRADIATE. Shipping container to be opened by UCCBB staff ONLY. Exempt Human Specimen. UN3373 Diagnostic Specimen.

16

17 HIPAA & Patient Confidentiality HIPAA: Health Insurance Portability and Accountability Act All information regarding patients and employees is always to be considered CONFIDENTIAL. Medical information, personal information, and private matters must be treated as such and should never be discussed with those not directly involved with the care of the patient

18 Summary Initial personnel training must occur within 90 days of employment. Proper packaging must include a primary receptacle, an absorbent material, a secondary packaging and a rigid outer packaging. Blood samples being transported to ClinImmune Labs should be placed in a temperature controlled package. All information regarding patients and employees is always to considered confidential.

19 Contacts Lab Manager: Laboratory:

20 References University of Colorado Denver UCD Shipping Biological Materials Online Training ClinImmune Labs SOP-Shipping Human Bodily Fluids SOP-Transportation, Tracking and Documentation of HPC, Cord Blood Units from the Collection Site to the HPC Processing Laboratory SOP-HIPAA ClinImmune

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