ML20246L083

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Requests Addl Info Re 880215 Application for Byproduct Matl License,Including Clarification Whether Procedures Requiring Patients to Ingest or Be Injected W/Radionuclides Will Be Performed
ML20246L083
Person / Time
Issue date: 03/10/1988
From: Matson E
NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III)
To: Branam G
PATHOLOGISTS ASSOCIATED, MUNCIE, IN
Shared Package
ML20246L066 List:
References
384905, NUDOCS 8903230013
Download: ML20246L083 (3)


Text

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MAR 101988 Pathologists Associated ATTN: George E. Branam, M.D.

407 West Main Street Muncie, IN.47305 i

Gentlemen:

We have reviewed your application dated February 15, 1988, requesting a new byproduct materials license and find that we will need additional information as follows:

1.

Please clarify if you will be performing any procedures which require patients to ingest or be injected with radionuclides.

If yes, you will need to file an application for human use in accordance with 10 CFR Part 35 and Regulatory Guide 10.8, Revision 2, August 1987, (copies enclosed).

2.

Describe the detector used on the CDV-700 portable G-M survey meter. To I

adequately detect low levels of iodine-125, you must use a very thin end I

window probe. Thick side wall probes are not effective in measuring low energy radionuclides.

3.

Describe your procedures for calibrating your analytical instruments and the survey meter.. Procedures for survey meters should be equivalent to those described in Appendix B of Regulatory Guide 10.8.

You may state you will follow the procedures in Appendix B.

However, state who will perform the calibrations.

4.

Describe your waste disposal procedures for contaminated solids such as glassware, paper, gloves, etc. See Appendix R of Regulatory Guide 10.8 for suggested procedures.

5.

Describe your routine survey program.

Include the following items:

I a.

Frequency of surveys.

Surveys should be conducted at least every two weeks.

b.

Type of surveys. Surveys should cover direct radiation levels when appropriate and removable contamination levels in all cases.

c.

Areas to be surveyed. All areas where radioactive material is used, received, stored and waste areas should be surveyed.

d.

Action levels and corrective actions. All areas showing greater than 200 disintegrations per minute per 100 cm2 must be decontaminated and resurveyed.

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Pathologists Associated 2
6. -

Radiation workers (technologists, etc.) must receive instruction as specified L-

~in 10 CFR 19.12 (enclosed). Note that many of these. items pertain;to circumstances at your particular institution; therefore, you may not assume that this-instruction has been adequately covered by prior. occupational training, Board certification, etc.

Please outline and submit your program for providing

' the. necessary instruction. Confirm that this instruction will be given both initially and annually thereafter on a' refresher basis, i

-7..

Ancillary personnel (clerical, nursing, housekeeping, security, etc.) whose duties may. require them to work in the _ vicinity of radioactive material

.(whether escorted ~or not) need to be informed about radiation hazards and appropriate precautions. Outline your method to assure that these employees receive.the necessary instructions.

Confirm that this instruction will be-given both initially and annually thereafter on a refresher basis.

8.

Describe your procedures for ordering radioactive materials, for receipt of materials and for notification of responsible persons upon receipt of radioactive materials. These procedures should be adequate to ensure that possession limits are not exceeded, that radioactive materials are secured against ut authorized removal at all times, and that radiation levels in unrestricted areas do not exceed the limits specified in Section 20.105 of r

10 CFR-Part 20.

9.

Describe your procedures for examining incoming packages and for safety opening packages. As a minimum, these include instructions to wear gloves, and survey the package for removable. contamination if the package is wet or damaged.. Procedures should include instructions on what to do if a package is leaking.

10. Describe your procedures to be followed in case of a spill of radioactive material.

Sample procedures are contained in Appendix J of Regulatory Guide 10.8 If you have any questions or require clarification on any of the information stated above, you may contact us at (312) 790-5625.

We will continue our review of your application upon receipt of this information.

Please reply in duplicate, within 10 days, and refer to Control Number 8t.905.

Sincerely, Evelyn R. Matson l

Materials Licensing Section j

Enclosures:

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10 CFR Parts 19,

~20, 30, 35 2.

Regulatory Guide 10.8 RIIId k' M

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INFORMATION FROM LITS BETWEEN!

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