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Interpretation Response #06-0094 ([Quest Diagnostics] [Mr. Nicholas Pagerly ])

Below is the interpretation response detail and a list of regulations sections applicable to this response.

Interpretation Response Details

Response Publish Date:

Company Name: Quest Diagnostics

Individual Name: Mr. Nicholas Pagerly 

Location State: PA Country: US

View the Interpretation Document

Response text:

Jul 31, 2006

 

Mr. Nicholas Pagerly                Reference No. 06-0094
Flight Operations Safety Officer
Manager, Specimen Packaging
Quest Diagnostics
159 Museum Road
Reading, PA 19605

Dear Mr. Pagerly:

This is in response to your April 18, 2006 letter concerning how to classify patient specimens offered for transport by aircraft under the International Civil Aviation Organization Technical Instructions for the Transport of Dangerous Goods by Air (ICAO Technical Instructions) and § 171.11 of the Hazardous Materials Regulations (HMR; 49 CFR Parts 17 1-180). You state your company may not have the specific information needed to determine if there is a “minimal likelihood” a patient specimen is an infectious substance (Division 6.2). You ask whether your medical experts can assess, based on the types of tests your laboratories perform, if there is a “minimal likelihood” a patient specimen contains a Biological substance, Category A or Category B, or an Exempt human specimen.

The answer is yes. While some tests for the presence of an infectious agent may be requested for patient samples as a routine healthcare practice, a receiver of such a sample in the absence of specific information may use the types of tests requested by a medical professional for a patient sample as an indication of the professional’s preliminary judgment of the patient’s condition. We have based this opinion on the determination by health care specialists and scientist at the World Health Organization and the U.S. Department of Health and Human Services that the risk of infection during transportation from samples taken from apparently healthy patients and animals and transported for
routine testing is extremely small. Conversely, if a human or animal sample is transported for other than routine testing when the testing is related to the diagnosis of an infectious disease and if there is reason to suspect that the sample is infectious, that sample is subject to the HMR.

I hope this information is helpful.

Sincerely,

 

Hattie L. Mitchell, Chief
Regulatory Review and Reinvention
Office of Hazardous Materials Standards

171.11, 173.134

Regulation Sections

Section Subject
173.134 Class 6, Division 6.2-Definitions and exceptions