UT Southwestern Medical Center — Hazardous Materials Safety Interpretation

Page 1U.S. Department of Transportation Pipeline and Hazardous Materials Safety 1200 New Jersey Ave.. S.E Washington. DC 20590 Dr. Frank H. Wians, Jr. Professor UT Southwestern Medical Center 5323 Harry Hines Boulevard Dallas, TX 75390-9073 Ref. No. 08-003 1 Dear Dr. Wians: This responds to your letter regarding the applicability of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-1 80). Specifically, you ask if the HMR apply to the manual (non-motorized) transfer of infectious substances between two contiguously located medical facilities. The HMR do not apply to the rail and motor vehicle movement of a regulated hazardous material exclusively within a contiguous facility boundary where public access is restricted. Moreover, the HMR only apply to the movement of hazardous materials transported by rail car, aircraft, motor vehicle, or vessel in commerce. Because the manual (non-motorized) transfer of infectious substances between two contiguously located medical facilities does not fall into either category, such transfers are not subject to the HMR. Itrust this satisfies your inquiry. Please contact us if we can be of further assistance. Sincerely, Hattie L. Mitchell Chief, Regulatory Review and Reinvention Office of Hazardous Materials Standards#

Page 2I FW: RE:'DBMainID=l15-508' Question on the Intra-institutionalTransport of MedicalEq ... Page 1 of 4 Drakeford, Carolyn cPHMSA> - - " " - - " - " " From: Leary, Kevin <PHMSA> Sent: Tuesday, January 29, 2008 3:14 PM To: Drakeford, Carolyn <PHMSA> Subject: FW: RE:'DBMainlD=ll5-508' Question on the Intra-institutionalTransport of MedicalEquipmentlSupplies/Rea -----Original Message----- From: Frank Wians [niail~:F~ank,Wi~i~@UJTS~~utl~~~este~n.cdu] Sent: Tuesday, January 29, 2008 12: 13 PM To: Smith, Chevella <PHMSA> Cc: Qasim Ansari Subject: Fwd: RE:'DBMainID= I 15-508' Question on the Intra-institutionalTransport of MedicalEquipmentISupplieslRea Chevella: Per our phone call this afternoon, my initial query (down further in this e-mail) to DOT was referred to Hazmat. I would greatly appreciate an authoritative response to my query below. Regards, FHW Frank H. Wians, Jr., Ph.D., MT(ASCP), DABCC, FACB Professor, Department of Pathology Director, Clinical Chemistry, Division of Clinical Pathology Director, Clinical Chemistry Fellowship Program Associate Director, Division of Clinical Pathology Editor-In-Chief, Laboratory Medicine UT Southwestern Medical Center 5323 Harry Hines Boulevard Dallas, TX 75390-9073 Phone: 2 14-648-7634; Fax: 2 14-648-8037 Pager: 2 14-920-4494 e-mail: frank.wians@utsouthwestern.edu http:li'pathcuric I .swmed.eddTeachingifellowsl~i~lclinical~fel low The information in this e-mail may be confidential andlor privileged. This e-mail is intended to be reviewed by only the individual or organization named above. If you are not the intended recipient or an authorized representative, you are hereby notified that any review, dissemination or copying of this e-mail and its attachments, if any, or the information contained herein is prohibited. If you have received this e-mail in error, please immediately notify the sender by return e-mail and delete this e-mail from your system. >>> "DOTComments" <dot.comments@ost.dot.gov> 1/29/08 1 1 :56:44 AM >>> Dear Dr. Wians, I suggest that you direct your question to the Office of Hazardous Materials Safety (HAZMAT). Contact information is as follows:#

Page 3I FW: RE:'DBMainID=l15-508' Question on the Intra-institutionalTransport of MedicalEq ... Page 2 of 4 The toll-free number (in the U.S.): 1-800-HMR-4922 (1 -800-467-4922) The toll number, for Washington DC andlor foreign residents: 202-366-4488. The hotline operates Monday through Friday from 9:00 am to 5:00 pm (EST). To contact HAZMAT Regional offices, please see: !?ff~:!lhaz~~,d.o_t.ttgov!c_~~~~taa~t/.lo~.l~t~n Otherwise, please see: http://hazmat.dot~gov/contactiinfo- fceclbk.htm (For text-only browsers, send feedback to: infocntr@dot.gov) For *IMMEDIATE EMERGENCY* notification of Hazardous Materials Incidents, please call the National Response Center (NRC): 800-424-8802 (toll-free) 202-267-2675 (toll) To access HAZMAT regulations and interpretations, please visit: 11tt~~:l!ww~v.myregs.conildotrs~ Sincerely, Reference Services National Transportation Library Bureau of Transportation Statistics Research and Innovative Technology Administration U. S. Department of Transportation - - -----Original Message----- From: Frank Wians (Frank.Wians@utsouthwestern.edu) Date: Friday, January 25, 2008 07:34 PM To: dot.comments@dot.gov (dot.comments@dot.gov) Cc: Qasim Ansari (Qasim.Ansari@utsouthwestern.edu) Subject: Question on the Intra-institutional Transport of MedicalEquipment/Supplies/Reagents To Whom It May Concern: I would greatly appreciate a DOT response to my question concerning 49 CFR Part 171 et al. Hazardous Materials: Revision to Standards for Infectious Substances; Final Rule, subpart 173.134, p53 139, b(6): "A diagnostic specimen or biological product when transported by a private or contract carrier in a motor vehicle used exclusively to transport diagnostic specimens or biological products. Medical or clinical equipment and laboratory products may be transported aboard the same vehicle provided they are properly packaged and secured against exposure or contamination. If a diagnostic specimen or biological product meets the definition of a regulated medical waste in paragraph (a)(5) of this section, it must be offered for transportation and transported in conformance with the appropriate requirements for regulated medical waste." As a prelude to my question, here's the background: 1. Testing for parathyroid hormone (PTH) directly in a surgical suite is performed currently at one of the hospitals [Zale Lipshy University Hospital (ZLUH)] comprising 'The University of Texas Southwestern Medical Center (UTSWMC) by wheeling a cart containing the instrument (DPC Immulite immunoassay analyzer) for performing PTH testing into the surgical suite where a patient is undergoing bilateral neck exploration for a possible parathyroid gland adenoma.#

Page 4FW: RE:'DBMainID=l15-508' Question on the Intra-institutionalTransport of MedicalEq ... Page 3 of 4 u 2. This cart is kept in the clinical laboratory within this hospital and wheeled to the surgical suite within this same hospital when needed in support of the aforementioned surgery. 3. The reagents used by the Immulite instrument are contained within the instrument, quality control reagents are on the cart, and the blood sample for testing is obtained from the patient in the surgical suite, with the cadinstrument ready for PTH testing, and the technologist adhering to all universal precautions regarding the handling and disposal of biological samples and medical waste. 4. Once all testing has been completed, the cart/supplies/reagents/control materials is returned to the laboratory and the patient's specimen(s) disposed of in accordance with standard laboratory procedures for the correct disposal of biological waste. Recently, one of the hospitals [Children's Medical Center (CMC)] aff~liated with UTSWMC and connected to the ZLUH, that does not have the necessary cart/instrument available for intra-operative PTH testing, asked that we (i.e., ZLUH Laboratory personnel) provide this testing in support of one of their patients. We want to wheel the aforementioned cart, with the instrument, capped reagents, and necessary supplies from the ZLUH Lab to the CMC surgical suite. Here's my question: Can we wheel this cart from the ZLUH Lab to the CMC surgical suite and back without violating the provisions of 49 CFR Part 171 et al. Hazardous Materials: Revision to Standards for Infectious Substances; Final Rule, subpart 173.134, p53 139, b (6), which I have quoted above, or any other applicable provisions? Yes/No? Whether your ruling is "yes" or "no," please explain your response as it relates to the aforementioned CFR provision or any other provisions that you cite in your response. For example, the provisions of subpart 173. I34 b(6) may not apply to the "manual" (i.e., not "transported by a private or contract carrier in a motor vehicle used exclusively to transport diagnostic specimens or biological products"), intra- institutional (i.e., within the geographic bounds of our medical center) transport of our cadinstrument/reagents/supplies. My interpretation of the provisions of subpart 173.134 b(6) is that these provisions apply only to the transport of biological products by motor vehicle and, therefore, do not apply to the "manual" transport of our cart/instrumentlreagents/supplies between contiguously located medical facilities. Am I right or wrong? I look forward to your response. Regards, FHW Frank H. Wians, Jr., Ph.D., MT(ASCP), DABCC, FACB Professor, Department of Pathology Director, Clinical Chemistry, Division of Clinical Pathology Director, Clinical Chemistry Fellowship Program Associate Director, Division of Clinical Pathology Editor-In-Chief, Laboratory Medicine UT southwestern Medical Center 5323 Harry Hines Boulevard#

Page 5FW: RE:'DBMainID=l15-508' Question on the Intra-institutionalTransport of MedicalEq ... Page 4 of 4 1 Dallas, TX 75390-9073 Phone: 2 14-648-7634; Fax: 2 14-648-8037 Pager: 2 14-920-4494 e-mail: frank.wians@utsouthwestern.edu http:.!!path_cu~L~.!.,sw.~.~d,_edu/Teac.t!.1.ndf1:!..~o~vsh ip!~.!..b!ic?l=.kl! ow The information in this e-mail may be confidential andlor privileged. This e-mail is intended to be reviewed by only the individual or organization named above. If you are not the intended recipient or an authorized representative, you are hereby notified that any review, dissemination or copying of this e-mail and its attachments, if any, or the information contained herein is prohibited. If you have received this e-mail in error, please immediately notify the sender by return e-mail and delete this e-mail from your system.#