infectious substance

Transportation of COVID-19 Diagnostic Samples

Transportation of COVID-19 Diagnostic Samples

Because of the ongoing Coronavirus Disease 2019 (COVID-19) public health emergency, there is a growing need for transportation of COVID-19 diagnostic samples (e.g., nasal swabs, vials of sputum, and other related items) from the points of sample collection to the labs for analysis. It is the responsibility of the Pipeline and Hazardous Materials Safety Administration within the U.S. Department of Transportation (USDOT/PHMSA) to ensure the safe transportation of all hazardous materials (HazMat) to, from, or through the U.S. The purpose of this article is to identify and explain the two available methods for the transportation of COVID-19 diagnostic samples.

Note:

This will require consideration of the transportation methods recommended by USDOT/PHMSA in its Safety and Advisory Notice for the Transportation of COVID-19 Diagnostic Samples.

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FAQ: What is a Category A Infectious Substance?

FAQ: What is a Category A Infectious Substance?

The Hazardous Materials Regulations (HMR) of the Pipeline and Hazardous Materials Safety Administration within the U.S. Department of Transportation (USDOT/PHMSA) classify and regulate the transportation of hazardous materials. Included in the twenty hazard classes and divisions identified in the HMR at 49 CFR 173.134 is Division 6.2 Infections Substance; Divisions 6.2 is further broken down into Category A and Category B.

The purpose of this article is to identify and explain (and provide examples of) a Category A Division 6.2 Infectious Substance.

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Q&A: Transport of Used Medical Devices

People find me in google searches – it happens! – and when they do they fire away with questions.  Like this one August 5, 2016:

I saw your web page and the invite to contact you with questions about the transportation of hazardous materials. My questions involve the shipping of used medical devices.

Example 1. A used biopsy sampling gun from a hospital being returned to the manufacturer for failure investigation.

Example 2. A used medical machine which collects urine which is being returned to the manufacturer for:

a) Reconditioning and return to same hospital or,

b) Disposal if broken.

Example 3. A used medical ultrasonic machine which comes in contact with various patients skin which is being returned to the manufacturer for reconditioning and return to same hospital.

Example 4. A used catheter being used for personal home healthcare being returned to the manufacturer for failure investigation.

It may be precautionary assumed that recondition / reusable devices being returned from a healthcare facility came in contact with bodily liquids from floors or sprays from patients.

It is also assumed that these liquids are Category B infectious substance.

What are the suggestions for each Example:

  1. Shipping Name
  2. Inner Packaging Material and Markings
  3. Outer Packaging Material and Markings
  4. Acceptable types of transportation (i.e. personal cars, company sales cars, licensed carriers, etc)

Also can any regulated hazardous material be shipped to any off-site storage facility while awaiting decision dispositions?

Thank you very much Daniel.

I was impressed – and a little intimidated – by the depth of his questioning:

Yow!  That’s a lot.  I’ll do my best to answer your questions in the next several days.

And several weeks later, I did (9.26.16):

I will do my best to answer your questions below.  I apologize for my delay.

  • All of what you describe meets the definition of a Used Health Care Product at 49 CFR 173.134(a)(8).
  • There is an exception from regulation as a hazardous material for used health care products at 49 CFR 173.134(b)(12)(ii).  Per this exception, a used health care product is not subject to USDOT regulations if the following conditions are met:
    • UHCP are drained of all free liquids.
    • UHCP are placed in a water-tight primary container.
    • Primary container is puncture-proof if required by UHCP.
    • BioHazard marking is displayed on primary container.
    • Primary container is placed in water-tight secondary container.
    • BioHazard marking is displayed on secondary container.
    • Secondary container is placed in outer packaging.
    • Sufficient cushioning is used to prevent movement of secondary container within outer packaging.
    • An itemized list of contents of secondary container and information regarding possible contamination with Division 6.2 infectious substance is placed between the secondary container and the outer packaging.
    • Persons involved in offering for transport or actual transport must know about the requirements of this exception.  HazMat Employee training is not required.

If packaged as summarized above (and explained in detail at 49 CFR 173.134(b)(12)(ii)), no other requirements of the USDOT Hazardous Material Regulations apply.

  1. Shipping name:  None.
  2. Inner packaging material and markings:  see above.
  3. Outer packaging material and markings:  see above.
  4. Acceptable transportation:  Any.  If the above is complied with, UHCP is not subject to USDOT regulation as a hazardous material.

Contact me with any questions you may have about the transportation of hazardous materials by air, highway, vessel, or rail

International and Domestic

Daniels Training Services

815.821.1550

Info@DanielsTraining.com

https://www.danielstraining.com/

Can any regulated HazMat be shipped to any off-site storage facility while awaiting decision dispositions?  I may need more information from you to understand exactly what you are asking but the short answer is yes.  USDOT does not regulate where a HazMat goes to.  Only that the Shipper is responsible to offer it to a transporter who then must transport it to its destination.

I hope this helps.
Please don’t hesitate to contact me with any other questions.

 

Q&A: Transporting an Infectious Substance (Division 6.2) in a Personal or Company Vehicle

I received this email January 25th from a customer who had attended one of my Training Seminars in the past:

Dan,
How have you been? You said to contact you if we have any questions. I was asked a question and I would like you to please review my answer. Can you help me out?

Question:
Can a 6.2 category B infectious substance be shipped in a personal or company vehicle?

Answer:
Yes, a company vehicle can be used to transport a 6.2 category B substance, if the following exemptions are met.
49 CFR 173.134 (b)(10) allows an exception to using a certified hazmat transporter to transport a category B substance for a patient sample (not a culture) and the private or contract carrier would have

A container for discarded sharps

Used hypodermic needles may be a category B, Infectious Substance

to be used exclusively to transport such materials. The vehicle couldn’t be a private vehicle but could be a company fleet vehicle. The vehicle could not be used for transporting anything else during that individual trip. The vehicle couldn’t be a general delivery vehicle making several stops. DOT training would be required and a Shipping document and DOT packaging would be needed.

49 CFR 173.6 Materials of Trade allows an exemption for small quantities of biological product, human or animal samples for research, diagnosis, disease treatment or prevention etc. The packaging would have to be securely closed and protect against damage and leaking. The driver would have to know what they are shipping and if a reportable quantity is present and the material of trade regulations. Does not require training or a shipping document.

Thanks,

My reply later that day:

Your answer may be correct.  Give me a day or two to review and reply.

Contact me with any questions you may have about the transportation of hazardous materials by air, highway, vessel, or rail

International and Domestic

Daniels Training Services

815.821.1550

Info@DanielsTraining.com

https://www.danielstraining.com/

My full response on January 26, 2016:

Thanks for contacting me.  I’ll do my best to answer your questions below.

Transportation by a private motor carrier of a Division 6.2 Category B Infectious Substance:

You are mostly correct about the exception at 49 CFR 173.134(b)(10).  Please see below for a breakdown of that paragraph:

  • Paragraph §173.134(b) identifies sixteen (16) materials not subject to the HMR as a Division 6.2.  If they are a HazMat for some other reason (e.g., a Class 3 Flammable Liquid), they are then subject to the HMR.  Read my article: Exceptions to Division 6.2 Infectious Substances.
  • §173.134(b)(10) is an exception for samples or biological products that meet the following conditions:
    • It is not a Category A infectious substance.  Category A infectious substance as defined at §173.134(a)(1)(i) can cause permanent disability, life-threatening, or fatal disease in an otherwise healthy person.
    • It is one of the following:
      • Contained in a patient sample and transported for research, diagnosis, investigational activities, or disease treatment or prevention.

Or…

      • A biological product.
    • Transported in a motor vehicle (by highway) used exclusively to transport such materials (patient sample or biological product).
    • Transported by one of following:
      • Private motor carrier (carrier owns material it transports).

Or…

      • Contract carrier (under contract for specific job).
    • The following are OK to transport with sample or biological product if properly packaged and secured against exposure:
      • Medical or clinical equipment and lab products.
    • If sample or biological product is regulated medical waste per §173.134(a)(5), it must be transported as such.  This may require compliance with §173.134(c).

Where I believe you to be in error:

  • “The vehicle couldn’t be a private vehicle…”  A private vehicle may be used as long as it is a private or contract carrier.
  • “The vehicle could not be used for transporting anything else during that individual trip.” Some other materials are allowed if packaged and secured properly.
  • “DOT training would be required and a Shipping document and DOT packaging would be needed.”  Per §173.134(b), those materials subject to the exception are not subject to the HMR as a Division 6.2 Infectious Substance.

You are correct about the use of the Materials of Trade Exception.

Please don’t hesitate to contact me with any other questions.

Interested in a Webinar that covers this topic, and more!

My Webinar Training Schedule

I think I answered his question satisfactorily:

Thanks Dan for your response. I look forward to attending future training sessions with you.

This customer did his own research before contacting me but you don’t have to!  If you have a question about the transportation of hazardous materials or the management of waste – hazardous, universal, used oil, even non-hazardous – don’t hesitate to contact me.

The exception at 49 CFR 173.134(b)(10) removes the requirement for HazMat Employee training; but you may still benefit from the training I can provide!

USDOT Regulations for Classification and Hazard Communication of Division 6.2 Infectious Substances in Transportation

The Pipeline and Hazardous Materials Safety Administration within the U.S. Department of Transportation (USDOT/PHMSA) creates and enforces the Hazardous Materials Regulations (HMR) for the transportation of hazardous materials (HazMat) within the U.S. One type of HazMat regulated by USDOT/PHMSA are substances that may cause sickness or death to humans or animals: Division 6.2 Infectious Substances.

The purpose of this article is to describe USDOT/PHMSA’s classification of a Division 6.2 Infectious Substance and the hazard communication: package labels, marks, and placards required for its transportation. (more…)

The Identification and Transportation of a Regulated Medical Waste

The Hazardous Material Regulations (HMR) of the PHMSA/USDOT regulate the transportation in commerce of an Infectious Substance (Hazard Class 6, Division 6.2).  The description of Division 6.2 at 49 CFR 173.134 includes a definition of both Regulated Medical Waste and Sharps, and an exception from full regulation under the HMR for Regulated Medical Waste if shipped as required.  The purpose of this article is to explain the requirements to comply with the exception for transportation of a Regulated Medical Waste. (more…)