{"operation":"document","citation":"06-0094","title":"Quest Diagnostics — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2006-07-31","effective_on":null,"summary":"06-0094 response to Quest Diagnostics concerning 173.134.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-06-0094.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-06-0094.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-06-0094","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2006/060094.pdf","body":"<<<PAGE 1>>>\n\nWashington, D.C. 20590\n400 Seventh Street, S.W.\nPipeline and\nAdministration\nHazardous Materials Safety\nJUL 31 2006\nMr. Nicholas Pagerly\nReference No. 06-0094\nManager, Specimen Packaging\nFlight Operations Safety Officer\n159 Museum Road\nQuest Diagnostics\nReading, PA 19605\nDear Mr. Pagerly:\nspecimens offered for transport by aircraft under the International Civil Aviation\nThis is in response to your April 18, 2006 letter concerning how to classify patient\nneeded to determine if there is a \"minimal likelihood\" a patient specimen is an infectious\nbstance (Division 6.2). You ask whether your medical experts can assess, based on t\npes of tests your laboratories perform, if there is a \"minimal likelihood\" a patiel\nspecimen contains a Biological substance, Category A or Category B, or an Exempt\nhuman specimen.\nThe answer is yes. While some tests for the presence of an infectious agent may be\nin the absence of specific information may use the types of tests requested by a medical\nrequested for patient samples as a routine healthcare practice, a receiver of such a sample\njudgment of the patient's condition. We have based this opinion on the determination by\nhealth care specialists and scientist at the World Health Organization and the U.S.\nfrom samples taken from apparently healthy patients and animals and transported for\nDepartment of Health and Human Services that the risk of infection during transportation\n171.11\n173.134\n060094\n\n<<<PAGE 2>>>\n\nroutine testing is extremely small. Conversely, if a human or animal sample is transported\nfor other than routine testing when the testing is related to the diagnosis of an infectious\ndisease and if there is reason to suspect that the sample is infectious, that sample is subject\nto the HIMR.\nI hope this information is helpful.\nSincerely,\nHattie L. Mitchell, Chief\nOffice of Hazardous Materials Standards\nRegulatory Review and Reinvention\n\n<<<PAGE 3>>>\n\n6103100389\nQUESI DIAGNUSIICS\n04:04:18 p.m\n04-18-2006\n212\nEdmonson\n313.134\nQuest\nDefinitions Exceptions\nDiagnostics\n06-0094\nApril 18, 2006\nNicholas Pagerly, Flight Operations Safety Officer,\n159 Museum Road\nManager, Specimen Packaging\nReading, PA 19605\n(800) 694-1247 Toll Free\n(610) 376-6389 Fax\nnicholas.a.pagerly@questdiagnostics.com\nDear Sirs,\nQuest Diagnostics is considering the feasibility of applying the procedures outlined\nin the ICAO Technical Instructions as they pertain to the transport: of infectious\nspecimens pursuant to CFR 49 171.11. Accordingly, Quest Diagnostics is currently\nexamining the possibility of making changes to the way in which it presently\nclassifies patient specimens for transport.\nDuring this examination a question has arisen regarding the definition of the term\n\"minimal likelihood\".\ndetermination of 'minimal likelihood\" is dependant upon a \"professional opinion\"\nIn the ICAO Guidance Document it states that the\nlocal conditions to name but a few.\nwhich is based upon the patient's medical record, exhibited symptoms and endemic\nAs a medical testing facility, we would not necessarily have this specific information\ntransport. What we do know is what test the patient's physician has ordered. As\nwhen a patient specimen is received at the laboratory to be packaged for further\nsuch, it is our opinion that by having our medical experts examine each of the test\ntypes that Quest Diagnostics currently offers; and by building a list of which tests\nshould be classified as Category A, Biological Substance, Category B, and Exempt\nHuman Specimen, this would then constitute a \"professional opinion\" and thereby\n\"minimal likelihood\" of harboring a potentially harmful pathogen.\ncomply with the regulatory requirement to determine that a patient specimen has a\non the validity of our due diligence.\nQuest Diagnostics is requesting that the DOT consider our example and comment\nSincerely,\nNicholas Pagerly","truncated":false,"body_characters":3866}