United States Nuclear Regulatory Commission - Protecting People and the Environment

Technical Assistance Request, Regarding Mediq Imaging, Inc., Providing Service to a Private Practice (Non-licensee) Located within a Hospital

HPPOS-320 PDR-9307060045

See the memorandum from J. E. Glenn to R. E. Bellamy dated January 25, 1993.

This NMSS memo responds to a technical assistance request (TAR) from Region I, dated July 16, 1992, regarding Mediq Imaging Associates, Inc., (MEDIQ) providing service to a private practice (non-licensee) located within a hospital.

MEDIQ rents space in the cardiology section of Atlanticare Medical Center in Lynn, Massachusetts. It is in this rented space that MEDIQ proposed the operation of a mobile nuclear cardiology laboratory, with the full knowledge of the Atlanticare administration. There will be no formal relationship between the established nuclear medicine program in the hospital and the MEDIQ mobile operation, and only ambulatory outpatients will be seen in the MEDIQ nuclear cardiology clinic; none of these patients would be expected to be returning to a hospital bed following a nuclear procedure. This program is basically a continuation of the long-standing mobile clinic that MEDIQ operated at Union Hospital in Lynn, an institution which is now closed due to a merger with the Atlanticare facility. The continuing need for cardiac nuclear medicine in this community is the basis for this request. That need is even more profound with the closure of Union Hospital, since the cardiologists involved have relocated to the Atlanticare Medical Center, the only remaining hospital in Lynn.

The NMSS responses to the two issues raised in the TAR are as follows:

  1. Clarify whether a mobile licensee can provide service to a private practice non-licensee) located within a hospital (institution).

    The mobile licensee cannot provide a service to a private practice non-licensee) located within a licensed hospital (institution).

  2. Is the hospital required to assume responsibility as the client as specified in 10 CFR 35.29 (c)?

According to the Statements of Consideration regarding 10 CFR 35.29: "When an NRC licensed hospital exercises its authority to invite a mobile nuclear medicine service to provide medical service, the NRC will deal with this as though the licensee has delegated tasks to another licensee. The NRC licensed hospital, not the mobile nuclear medicine service, will normally be held responsible for items of non-compliance that occur at the hospital." Therefore, since the hospital would need to invite MEDIQ to perform medical services, the hospital will be required to assume responsibility as the client.

The intent of 10 CFR 35.12 (a) and 10 CFR 35.29 (c) are to prevent confusion or conflicting requirements regarding control of access to byproduct materials. MEDIQ has not presented any explanation as to why the hospital cannot assume this responsibility nor how MEDIQ could assure adequate control of byproduct material given that there "will be no formal relationship between the established nuclear medicine program in the hospital and the MEDIQ operation."

Regulatory references: 10 CFR 35.12, 10 CFR 35.29

Subject codes: 11.3

Applicability: Byproduct Material

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