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APR 0 3 885 FEMORANDtH FOR: Samuel J. Chilk Secretary of the Commission FROM: William J. Dircks Executive Director for Operations SURJECT: AMENDMENTS TO 10 CFR PART 35 LICENSES At the Parch 20, 1985 Commission meeting nn the proposed revision of 10 CFR Part 35. "Pedical tise of Byproduct t'aterial," the staff was asked to characterize licensees' requests for license amendments. - The staff has analyzed 100 recent medical license amendments, selected in order of receipt (this represents a sample of 5 percent of 10 CFR Part 35 license amendment requests for a calendar year). The results follow:
t; umber of Completed Actions that were Analyzed: 100*
Number of Requests that Included a Major Change which would require an amendment unEr the pro-posed revision of 10 CFR Part 35: 69 e Ilsers - 51 e Type of Use - 15 e location - 5 o Inventory - 2 Number of Requests for an Administrative Change, e.g.. name change, change of address but not location, short-tenn extension, etc.: 6 Number of Requests that Included a Minor Change which would not require an amendment under the proposed revision of 10 CFR Part 35: 37 e Area of Use - 21 e Replaceme,nt Equipnent - 5 , ,
8509230363 850906 PDR PR 35 50FR30616 PDR
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- Some . requests contained both Major and Minor changes and therefore were tallied twice; thus the division by Major, Administrative and Minor does not add up to 100.
The average time to complete action on these 100 amendments was 62 calendar days; about 40 percent of both hospital and private practice requests were deficient. There were no suhnissions that had major safety deficiences.
All the minor safety deficiencies were in areas where requirenents are not cl ea r or a re sca ttered . Some minor deficiencies were administrative in nature, e.g., wrong fee, Chief Executive Officer did not sign the a ppli cation.
It was also suggested during the meeting that perhaps large hospitals should be allowed to nake minor changes in their radiation safety programs, but that small hospitals and private practice physicians should be required to submit their minor changes for regulatory review. The measure of hospital size could be the number of beds in the hospital; a demarca-tion line of 200 beds was suggested. The staff has analyzed this proposal by measuring whether large hospitals submit fewer deficient anendnent requests than small hospitals.
For the sample of 100 recent medical license anendment requests, the staff was able to detemine the number of beds for 64 of the 88 hospitals that submitted such requests; the other 12 requests were submitted by private practice physicians. A table that shows the fraction of amendment requests that were deficient for different hospital sizes appears below:
Number of Fraction Anendment that was Bed Size Requests Defi cient Infomation Not Available 24 42 Private Practitioners 12 42 1-199 20 40 200-399 25 44 400- 10 .53 CATEk ................ .... .................... ..................
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Samuel J. Chilk 3 Based on this analysis, the staff has concluded that the num.her of beds in a hospital does not provide a valid basis for distinguishing in the regulatory treatment of medical licensees.
(Siped) William 1.Direks William J. Dircks Executive Director for Operations DISTRIBUTION:
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