ML20213F757
| ML20213F757 | |
| Person / Time | |
|---|---|
| Issue date: | 12/31/1985 |
| From: | Joyner J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| To: | Cobb L, Miller V NRC OFFICE OF INSPECTION & ENFORCEMENT (IE), NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20213F749 | List: |
| References | |
| FOIA-86-759 NUDOCS 8611170134 | |
| Download: ML20213F757 (2) | |
Text
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I i ,
UNITED STATES
. [g,,a ttag o, NUCLEAR REGULATORY COidMIC310N
[ jg. r h REGION I 3% j 431 PARK AVENUE usNG OF PRUS$t A. PENNSYLVANI A 19404 i ....* DEC 311985
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MEMORANDUM FOR: Vandy J. Miller, Chief, Materials Licensing Branch, NMSS j ,, Leonard I. Cobb, Chief Safeguards & Materials Programs i
Branch, IE FROM:
James H. Joyner, Chief Nuclear Materials Safety &
Safeguards Branch i
SUBJECT:
' REQUEST FOR GUIDANCE ON PERMISSIBLE DELEGATION OF RESPONSIBILITIES BY PHYSICIAN USERS TO SUPERVISED PHYSICIANS Region I requests guidance regarding " unauthorized use" by physicians. My i
i staff believed that they had a good understanding of duties which could be delegated by physicians and the requirements for supervision of individuals to j
whom duties were delegated.. Based on pages 10.8-3 and 10.8-4 of Regulatory Guide 10.8, in particular, and many discussions with the NMSS staff, in i~
general, we believed that the NRC policy was that clinical management of patients could only be delegated to physicians being trained to qualify as
- authorized users. By clinical management, we mean the selection of patients for nuclear medicine studies, the prescription of the dose and the interpretation of the test results. However, the statements in a September 24, 1985 letter to Christian Hospital, signed by Vandy Miller, lead us to believe that our understandings may be in error. We are requesting guidance because we have a specific case which we must resolve soon.
' During an inspection of Pesara Pashpamala Reddy, M.D. (L/N 37-18422-01, copy enclosed)onSeptember 21, 1984, our inspector determined that on 8 out of 9 j
occasions reviewed, the selection of the patient and the interpretation of images had been performed by physicians not named on this private practice license. It was the finding of our inspector that Dr. Reddy had minimal involvement with the activities conducted under her license. Consequently, a Notice of Violation was issued on November 2,1984 (copy enclosed). A part of
- our basis for finding a violation was the wording of Condition 12, which 4
states: " Licensed material shall be used by Pesara Pushpamala Reddy, M.D."
Our understanding of this wording has been that it permits delegation of certain duties to technologists, but does not permit delegation of any portion of the clinical management of radioisotope patients to other physicians.
j By letter dated November 30,1984 (copy enclosed), Dr. Reddy contested our finding by stating that these physicians had been under her supervision. In a letter dated March 14,1985 (copy enclosed), my staff restated our interpre-l tation of the authorized user condition in some detail and asked Dr. Reddy to -
confirm that the clinical management (selection of patients, prescription of
- doses, and interpretation of images) would be performed only by named j
' physicians. Dr. Reddy has not responded to this letter, but by letter dated j
August 27, 1985, requested the addition of a physician as an authorized user, i
Since this physician's clinical experience was received under Dr. Reddy's private practice license, wh conclude that the preceptor statement is inade-quate. We also believe that Dr. Reddy should be put on notice that continued N $
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Vandy J. Miller 2 DG 311985 delegation of clinical responsibilities and training of physicians under her private practice license could constitute a willful violation. A dra f t deficiency letter is enclosed.
We request your guidance on the following issues:
1.
Can duties restricted to physician (clinical management of radioisotope patients) be delegated to physicians not in a formal training program at an institution? For example, can physicians who never intend to become authorized users perform this function under appropriate supervision?
- 2. If the answer to question 1 is yes, can the same delegation be made under a private practice license?
- 3. If the answer to question 2 is yes, do you recommend that our citation against Dr. Reddy be withdrawn?
4.
If the. answer to question 2 is no, we plan to use strong language to put Dr. Reddy on notice that the continuation of this practice will result in d significant enforcement action. Do you agree that such a violation is serious and merits strong enforcement action?
- 5. Is our understanding correct that acceptable clinical experience cannot be obtained under a private practice license?
In addition to the guidance requested above, we believe that the language of the user condition and the written guidance available to licensees needs to be made very explicit. We suggest that different conditions be used for medical and nonmedical licenses and that an explanation be provided with each license and renewal. We would be happy to work on producing such a document after reviewing your guidance.
h 7'
es H.
w ner, Chief l Nuclear Materials Safety and
, Safeguards Branch
Enclosures:
- 1. License No. 37-18422-01
- 2. Letter to Christian Hospital dated September 24, 1985
- 3. Letter to Dr. Reddy dated November 2, 1984
- 4. Letter from Dr. Reddy dated November 30, 1984
- 5. Letter to Dr. Reddy dated March 14, 1985 l
- 6. Draf t Letter to Dr. Reddy l
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