ML20137Q926
| ML20137Q926 | |
| Person / Time | |
|---|---|
| Issue date: | 01/11/1984 |
| From: | Potter J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II) |
| To: | Glenn J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| Shared Package | |
| ML20136D915 | List:
|
| References | |
| FRN-50FR30616, RULE-PR-35 AA73-1, NUDOCS 8509230318 | |
| Download: ML20137Q926 (4) | |
Text
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e WINTED STATet *
^ NUCLEAR RESULATORY COAmm8800N .I.1; 'l neemsa t, l te1 MAMETTA STREET,NN. -}l y*...*)
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MEMORANDUM FOR: John Glenn, Chief, MtP Section, RI {
FROM: John Potter, Chief, MRP Section, RI! ,
i SWELIECT: DRAFT RECODIFICATION OF 10 CFR 35 i (YOUR FAX TO J. POTTER, 12/21/83) '
Pursuant to your request, as the NRC regional coordinator, we offer comments .
on the subject draft as indicated in the enclosure. Phil Chambless is our Task Group Representative and was the principal author of these comments. ,
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e John Potter A
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4 ENCLOSURE :
Comments
- 81. Page 53 " Misadministration" Comment - Eliminate #5 -
_ Reason-Therapeutic Misadministrations can occur because of human error such '
as an addition or subtraction error (and actually has in RII). The Commission should only be concerned in those misadministrations that occur 9..
because of errors in source calibration, time of exposure, etc. since these >
could (1) Be an actual violation of a license condition or regulation (misadministrations per se are not) or, (2) Se an issue of generic interest to other licensees.
, Note-All of the licencee's I have spoken with agree with this point of view.
- 82. Page 55 Paragraph (d)(2) '
6 Need to include Puerto Rico and the U. S. Virgin Islands. .,
Why send licensing materials to headquarters as indicated in ;
Paragraph (e)?
F 3. Page 61 - 35.34 Visitina Authorized User ,
Should extend the period of temporary use to perhaps 90 days or longer. . *f There is no rationale for limiting it to 60 days since the licensee '
reviews the qualifications of the visiting user and not the NRC. '
84.
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35.49 - Suppliers Can a hospital be a " supplier" to other hospitals of unit dosages without being licensed to do so as a " Nuclear Pharmacy"?
. Vs. e.,. o< . so.oo Para (b)(1) is quite a divergence from current philosophy in Reg. Guide 10 A
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Do we still want daily checks using low, medium and high energy As written, a licensee could do daily checks sources? If so, say so.
w/ Ra88'only; and if he chose the 50uct of a other T-emitting nuclide, why couldn't he use Co'Jn (an energy totally inappropriate). <
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- 4. Page 64 para (b)(3) -
- Linearity 4
- 1. " Highest dosage that will be administered" might be as low as i
20 aC1 and yet an elution from their generator might be as high as 400 act which is used as the " stock" Tcm elution. The rule should reflect the current accepted practice in R.G 10.8. /
- 2. The assumption here is that the licensee can use any method they "y choose for performing linearity. (i .e. the "old" method, cali-check or lineator, etc.). '"
[7. Page 70 - 35.60 Should include "... who administers gr. draws a radio pharmaceutical /
k Exposure to the . fingers can be higher drawing a dosage than administering a dosage.
( [8. Page 72 - 35.80 " Mobile 5evice" -
- 1. Should be a statemen't that licensees operating a mobile service should l eempTy with Part 71 as far as their transportation of RAM.
! 2. When does a mobile service become a nuclear pharmacy and thus be 9
) licensed in accordance w/10CFR 32.72 and 73, and thus either be .?, ,
[ excepted by FDA or have a State Pharmacy License? How many hospitals '
can they service without requiring a State Pharmacy License? l;
, . 3. There are eenerallu two types of mobile services: (1) pharmaceuticals D carried to facilit< es who own their own equipment; or (2) equipment gg .
pharmaceuticals carried to the facilities In the second case, QA checks should be required on the equipment before it is put into use since transporting the devices can change their calibrations or affect operation of the PM tubes.
? 4. There should also be a requirement to perform vehicle surveys in the O 1
second case above since doses will be ahinistered in the vehicle
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- 5. Special provisions thould be included for the membership of the Rad.
Safety Committee for a mobile service because of several different 0l .
administrations, nursing staffs, etc. involved (i.e. Representation from each institution served since their facilities are likely to be
- used).
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- 6. Should the mobile service licensee management have to include the .
authorited physician users as officers of the company in order to insure appropriate management control?
fg. Page 74 - 35.120 What about diettal auto-ranging protable survey meters? This statement O as written simply wouldn't apply to these type meters.
Should read instead "... not more than 1 mr/hr or digital survey meter capable of reading in tenths of a ar/hr.
- [ 10._ Page 76 '_35.204 Should include a statement to the effect that for a licensee using a U nuclear pharmacy for individual doses, in lieu of performing their own moly-breakthru, they only need a statement from the Pharmacy that these tests are done on each slution.
/> 11.' Page 76 - 35.205 Should include provisions for testing ventilation rates in rooms if /
this is the preferred method for controlling airborne contamination; .
preferably every 6. ponths or after each' change in the facility which would affect air flow in'the Nuc. Med. Department.
[ 12. Page 81 - 35.60 .
Why must the qualified expert be specifically listed on the license? !~
It is sufficient to require the licensee to use a qualified expert for 3
the required tests on their unit, but a smaT hospital might need te -
. use several different physicist in the course of five years. What are we gaining by having them amend their license for a new physicist when the licensee reviews the qualifications and not the NRC7 This should be deleted and the definition of the qualified empert I should be amended to delete the implication that the person is actually listed on the license.
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