ML20127A757

Responds to Request for Review of 850115 Memo Re Improvements in Insp Programs for Medical Licensees.Concurs w/2 Yr Insp Interval for Nuclear Pharmacies & Broad Medical Licensees

ML20127A757
Person / Time
Issue date:	02/15/1985
From:	Everett R NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION V)
To:	Cobb L NRC OFFICE OF INSPECTION & ENFORCEMENT (IE)
Shared Package
ML20127A504	List: ML20127A502 ML20127A686 ML20127A703 ML20127A708 ML20127A724 ML20127A757 ML20127C120 ML20127C415 ML20127C475
References
FOIA-85-69 NUDOCS 8506210246
Download: ML20127A757 (2)

Text

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$8 'o,, UNITED STATES

!" o NUCLEAR REGULATORY COMMISSION

$ I REGION IV o 611 RYAN PLAZA DRIVE. SulTE 1000 g . . . . . ,o'[ AR LINGTON, TEXAS 79011 FER151%

MEMORANDUM FOR: L. I. Cobb, Chief, Safeguards and Materials Programs Branch, IE FROM: R. J. Everett, Acting Chief, Nuclear Materials Safety and Safeguards Branch, Region IV

SUBJECT:

IMPROVEMENTS IN THE INSPECTION PROGRAM FOR MEDICAL LICENSEES In response to your memorandum of January 15, 1985, same subject, we have the following comments:

Inspection Frequencies We concur that a 2 year inspection interval is appropriate for nuclear pharmacies and broad medical licensees. For limited diagnostic and therapeutic programs that are authorized technetium generators and significant amounts of iodine-131 and phosphorus-32, some Region IV inspectors expressed the opinion that a 5 year inspection interval may be too long. We do not have any data to support a change in inspection frequency but you may want to look further into the priority for these licensees.

Your narrative implies that limited diagnostic and therapeutic programs are classified as G(2)5 only when used in a nongroup private practice. Table 1 of MC 2800 allows this classification for medical institutions also.

Emphasis During_ Inspections The following topics are considered essential in any medical inspection and the order of listing in our judgement as to approximate priority.

1. Independent measurements by the inspector in the work place and unrestricted areas.

2. Interviews with personnel and observation of work practices.

3. Personnel exposures and licensee surveys.

4. Waste storage and disposal.

5. Licensee procedures for the receipt, handling, storage, and shipment of radioactive material.

6. Facility layout and ALARA program.

7. Records, QA activities, and licensee reports.

t, 69 P

L. I. Cobb Methods of Inspections We consider the direct observation of tests, surveys, and the handling of radioactive material to be essential in order to determine the level of worker training and competence.

Training Since we have been unable to obtain formal training for the inspectors in this

' area, we have resorted to on-the-job training by senior inspectors. This is very time consuming. We maintain that an adequate formal training course can be developed. We recommend that the training consist of two phases, one would address the medical tests, equipment, and procedures of a comprehensive medical program, and the other would address the regulatory and health physics aspects of medical uses. The former could be handled by a large medical institution and the latter by an experienced senior materials inspector. The well logging course is a good example of this type of format. This course has been well received because of this approach.

Regulatory Problem t'

We believe that the area of diagnostic treatment needs to be carefully reviewed to see whether some modest QC effort could reduce the large volume of diagnostic misadministrations we receive routinely. These misadministrations i appear to be caused mainly by human error that could be addressed by several l QA methods, g, ,p:/// '

R. J. Everett, Acting Chief Nuclear Materials Safety and Safeguards Branch 1

cc:

J. H. Joyner, RI

K. P. Barr, RII W. L. Axelson, RIII J. L. Montgomery, RV

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