Qualification of a medical courier

AwwPhooey

Registered
Hi there Elsmar Colleagues - I hope I selected the correct forum for my question.

Short version - I am the Supplier/Vendor Quality Manager for a clinical start-up working within cancer therapeutics. Previous to this position I held a number of Quality related roles over a 20 year span at a large Swiss owned commercial biologics company, 4 of those years within Supplier Quality there, also.

Most of my experience in SQ is working with direct material manufactures (filters, chemicals, SUT, etc.), but I’ve been asked recently to work on a qualification process for medical couriers, as we utilize patient donor material collected from several sites across many locations.

I'm sure many Quality Systems attributes still apply with couriers as do with material manufacturers, but I’m note sure what other things to think about.

Googling on the web for ideas, I’ve made note of the following things recommended to consider:
  • Business License
  • Transportation Permits
  • Healthcare-related permits (such as permits for handling medical waste or transporting biological specimens)
  • Health Insurance Portability and Accountability Act (HIPAA) Compliance Certification
  • Driver’s License
  • Courier and Delivery Services Certification
I figure I can work these aspects into the process; if there are any SQ folks out there who have some experience in this particular area, would appreciate any guidance you’d be willing to provide.

Thank you in advance,

Steve
 

GStough

Leader
Super Moderator
Hi there Elsmar Colleagues - I hope I selected the correct forum for my question.

Short version - I am the Supplier/Vendor Quality Manager for a clinical start-up working within cancer therapeutics. Previous to this position I held a number of Quality related roles over a 20 year span at a large Swiss owned commercial biologics company, 4 of those years within Supplier Quality there, also.

Most of my experience in SQ is working with direct material manufactures (filters, chemicals, SUT, etc.), but I’ve been asked recently to work on a qualification process for medical couriers, as we utilize patient donor material collected from several sites across many locations.

I'm sure many Quality Systems attributes still apply with couriers as do with material manufacturers, but I’m note sure what other things to think about.

Googling on the web for ideas, I’ve made note of the following things recommended to consider:
  • Business License
  • Transportation Permits
  • Healthcare-related permits (such as permits for handling medical waste or transporting biological specimens)
  • Health Insurance Portability and Accountability Act (HIPAA) Compliance Certification
  • Driver’s License
  • Courier and Delivery Services Certification
I figure I can work these aspects into the process; if there are any SQ folks out there who have some experience in this particular area, would appreciate any guidance you’d be willing to provide.

Thank you in advance,

Steve
Hi Steve,
What about some sort of training for the courier that pertains to the actual handling of (not so much the transporting) of medical waste and biological specimens - such as temperature requirements, storage and expiry of the waste or specimens, personal protective equipment that may be required, etc.? Would these topics be covered in the requirements for the healthcare-related permits?
 
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