{"operation":"document","citation":"08-0031","title":"UT Southwestern Medical Center — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2008-03-14","effective_on":null,"summary":"08-0031 response to UT Southwestern Medical Center concerning 171.1, 173.134.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-08-0031.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-08-0031.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-08-0031","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2008/080031.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department\nof Transportation\nPipeline and Hazardous\nMaterials Safety\n1200 New Jersey Ave.. S.E\nWashington. DC 20590\nDr. Frank H. Wians, Jr.\nProfessor\nUT Southwestern Medical Center\n5323 Harry Hines Boulevard\nDallas, TX 75390-9073\nRef. No. 08-003 1\nDear Dr. Wians:\nThis responds to your letter regarding the applicability of the Hazardous Materials\nRegulations (HMR; 49 CFR Parts 171-1 80). Specifically, you ask if the HMR apply to the\nmanual (non-motorized) transfer of infectious substances between two contiguously located\nmedical facilities.\nThe HMR do not apply to the rail and motor vehicle movement of a regulated hazardous\nmaterial exclusively within a contiguous facility boundary where public access is restricted.\nMoreover, the HMR only apply to the movement of hazardous materials transported by rail\ncar, aircraft, motor vehicle, or vessel in commerce. Because the manual (non-motorized)\ntransfer of infectious substances between two contiguously located medical facilities does not\nfall into either category, such transfers are not subject to the HMR.\nItrust this satisfies your inquiry. Please contact us if we can be of further assistance.\nSincerely,\nHattie L. Mitchell\nChief, Regulatory Review and Reinvention\nOffice of Hazardous Materials Standards\n\n<<<PAGE 2>>>\n\nI FW: RE:'DBMainID=l15-508' Question on the Intra-institutionalTransport of MedicalEq ... Page 1 of 4\nDrakeford, Carolyn cPHMSA>\n- - \" \" - - \" - \" \"\nFrom: Leary, Kevin <PHMSA>\nSent: Tuesday, January 29, 2008 3:14 PM\nTo: Drakeford, Carolyn <PHMSA>\nSubject: FW: RE:'DBMainlD=ll5-508' Question on the Intra-institutionalTransport of\nMedicalEquipmentlSupplies/Rea\n-----Original Message-----\nFrom: Frank Wians [niail~:F~ank,Wi~i~@UJTS~~utl~~~este~n.cdu]\nSent: Tuesday, January 29, 2008 12: 13 PM\nTo: Smith, Chevella <PHMSA>\nCc: Qasim Ansari\nSubject: Fwd: RE:'DBMainID= I 15-508' Question on the Intra-institutionalTransport of MedicalEquipmentISupplieslRea\nChevella:\nPer our phone call this afternoon, my initial query (down further in this e-mail) to DOT was referred to Hazmat.\nI would greatly appreciate an authoritative response to my query below.\nRegards,\nFHW\nFrank H. Wians, Jr., Ph.D., MT(ASCP), DABCC, FACB\nProfessor, Department of Pathology\nDirector, Clinical Chemistry, Division of Clinical Pathology\nDirector, Clinical Chemistry Fellowship Program\nAssociate Director, Division of Clinical Pathology\nEditor-In-Chief, Laboratory Medicine\nUT Southwestern Medical Center\n5323 Harry Hines Boulevard\nDallas, TX 75390-9073\nPhone: 2 14-648-7634; Fax: 2 14-648-8037\nPager: 2 14-920-4494\ne-mail: frank.wians@utsouthwestern.edu\nhttp:li'pathcuric I .swmed.eddTeachingifellowsl~i~lclinical~fel low\nThe information in this e-mail may be confidential andlor privileged. This e-mail is intended to be reviewed by only the\nindividual or organization named above. If you are not the intended recipient or an authorized representative, you are hereby\nnotified that any review, dissemination or copying of this e-mail and its attachments, if any, or the information contained\nherein is prohibited. If you have received this e-mail in error, please immediately notify the sender by return e-mail and\ndelete this e-mail from your system.\n>>> \"DOTComments\" <dot.comments@ost.dot.gov> 1/29/08 1 1 :56:44 AM >>>\nDear Dr. Wians,\nI suggest that you direct your question to the Office of Hazardous Materials Safety (HAZMAT). Contact information is as\nfollows:\n\n<<<PAGE 3>>>\n\nI FW: RE:'DBMainID=l15-508' Question on the Intra-institutionalTransport of MedicalEq ... Page 2 of 4\nThe toll-free number (in the U.S.): 1-800-HMR-4922 (1 -800-467-4922)\nThe toll number, for Washington DC andlor foreign residents: 202-366-4488.\nThe hotline operates Monday through Friday from 9:00 am to 5:00 pm (EST).\nTo contact HAZMAT Regional offices, please see: !?ff~:!lhaz~~,d.o_t.ttgov!c_~~~~taa~t/.lo~.l~t~n\nOtherwise, please see: http://hazmat.dot~gov/contactiinfo- fceclbk.htm\n(For text-only browsers, send feedback to: infocntr@dot.gov)\nFor *IMMEDIATE EMERGENCY* notification of Hazardous Materials Incidents, please call the National Response Center\n(NRC):\n800-424-8802 (toll-free)\n202-267-2675 (toll)\nTo access HAZMAT regulations and interpretations, please visit: 11tt~~:l!ww~v.myregs.conildotrs~\nSincerely,\nReference Services\nNational Transportation Library\nBureau of Transportation Statistics\nResearch and Innovative Technology Administration\nU. S. Department of Transportation\n- -\n-----Original Message-----\nFrom: Frank Wians (Frank.Wians@utsouthwestern.edu)\nDate: Friday, January 25, 2008 07:34 PM\nTo: dot.comments@dot.gov (dot.comments@dot.gov)\nCc: Qasim Ansari (Qasim.Ansari@utsouthwestern.edu)\nSubject: Question on the Intra-institutional Transport of MedicalEquipment/Supplies/Reagents\nTo Whom It May Concern:\nI would greatly appreciate a DOT response to my question concerning 49 CFR Part 171 et al. Hazardous Materials: Revision\nto Standards for Infectious Substances; Final Rule, subpart 173.134, p53 139, b(6):\n\"A diagnostic specimen or biological product when transported by a private or contract carrier in a motor vehicle used\nexclusively to transport diagnostic specimens or biological products. Medical or clinical equipment and laboratory products\nmay be transported aboard the same vehicle provided they are properly packaged and secured against exposure or\ncontamination. If a diagnostic specimen or biological product meets the definition of a regulated medical waste in paragraph\n(a)(5) of this section, it must be offered for transportation and transported in conformance with the appropriate requirements\nfor regulated medical waste.\"\nAs a prelude to my question, here's the background:\n1. Testing for parathyroid hormone (PTH) directly in a surgical suite is performed currently at one of the hospitals [Zale\nLipshy University Hospital (ZLUH)] comprising 'The University of Texas Southwestern Medical Center (UTSWMC) by\nwheeling a cart containing the instrument (DPC Immulite immunoassay analyzer) for performing PTH testing into the\nsurgical suite where a patient is undergoing bilateral neck exploration for a possible parathyroid gland adenoma.\n\n<<<PAGE 4>>>\n\nFW: RE:'DBMainID=l15-508' Question on the Intra-institutionalTransport of MedicalEq ... Page 3 of 4\nu 2. This cart is kept in the clinical laboratory within this hospital and wheeled to the surgical suite within this same hospital\nwhen needed in support of the aforementioned surgery.\n3. The reagents used by the Immulite instrument are contained within the instrument, quality control reagents are on the cart,\nand the blood sample for testing is obtained from the patient in the surgical suite, with the cadinstrument ready for PTH\ntesting, and the technologist adhering to all universal precautions regarding the handling and disposal of biological samples\nand medical waste.\n4. Once all testing has been completed, the cart/supplies/reagents/control materials is returned to the laboratory and the\npatient's specimen(s) disposed of in accordance with standard laboratory procedures for the correct disposal of biological\nwaste.\nRecently, one of the hospitals [Children's Medical Center (CMC)] aff~liated with UTSWMC and connected to the ZLUH, that\ndoes not have the necessary cart/instrument available for intra-operative PTH testing, asked that we (i.e., ZLUH Laboratory\npersonnel) provide this testing in support of one of their patients.\nWe want to wheel the aforementioned cart, with the instrument, capped reagents, and necessary supplies from the ZLUH Lab\nto the CMC surgical suite.\nHere's my question:\nCan we wheel this cart from the ZLUH Lab to the CMC surgical suite and back without violating the provisions of 49 CFR\nPart 171 et al. Hazardous Materials: Revision to Standards for Infectious Substances; Final Rule, subpart 173.134, p53 139, b\n(6), which I have quoted above, or any other applicable provisions? Yes/No?\nWhether your ruling is \"yes\" or \"no,\" please explain your response as it relates to the aforementioned CFR provision or any\nother provisions that you cite in your response.\nFor example, the provisions of subpart 173. I34 b(6) may not apply to the \"manual\" (i.e., not \"transported by a private or\ncontract carrier in a motor vehicle used exclusively to transport diagnostic specimens or biological products\"), intra-\ninstitutional (i.e., within the geographic bounds of our medical center) transport of our cadinstrument/reagents/supplies.\nMy interpretation of the provisions of subpart 173.134 b(6) is that these provisions apply only to the transport of biological\nproducts by motor vehicle and, therefore, do not apply to the \"manual\" transport of our cart/instrumentlreagents/supplies\nbetween contiguously located medical facilities.\nAm I right or wrong?\nI look forward to your response.\nRegards,\nFHW\nFrank H. Wians, Jr., Ph.D., MT(ASCP), DABCC, FACB\nProfessor, Department of Pathology\nDirector, Clinical Chemistry, Division of Clinical Pathology\nDirector, Clinical Chemistry Fellowship Program\nAssociate Director, Division of Clinical Pathology\nEditor-In-Chief, Laboratory Medicine\nUT southwestern Medical Center\n5323 Harry Hines Boulevard\n\n<<<PAGE 5>>>\n\nFW: RE:'DBMainID=l15-508' Question on the Intra-institutionalTransport of MedicalEq ... Page 4 of 4\n1 Dallas, TX 75390-9073\nPhone: 2 14-648-7634; Fax: 2 14-648-8037\nPager: 2 14-920-4494\ne-mail: frank.wians@utsouthwestern.edu\nhttp:.!!path_cu~L~.!.,sw.~.~d,_edu/Teac.t!.1.ndf1:!..~o~vsh ip!~.!..b!ic?l=.kl! ow\nThe information in this e-mail may be confidential andlor privileged. This e-mail is intended to be reviewed by only the\nindividual or organization named above. If you are not the intended recipient or an authorized representative, you are hereby\nnotified that any review, dissemination or copying of this e-mail and its attachments, if any, or the information contained\nherein is prohibited. If you have received this e-mail in error, please immediately notify the sender by return e-mail and\ndelete this e-mail from your system.","truncated":false,"body_characters":9988}