ML19296F459
| ML19296F459 | |
| Person / Time | |
|---|---|
| Issue date: | 10/08/1980 |
| From: | James Keppler NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | Lagro R COMMUNITY HEALTH CENTER OF BRANCH COUNTY, COLDWATER |
| Shared Package | |
| ML19296F460 | List: |
| References | |
| NUDOCS 8010210389 | |
| Download: ML19296F459 (3) | |
Text
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,( e* MCoq[g UNITED STATES NUCLEAR REGULATORY COMMISSION y
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OCT a ma Community Health Center License No. 21-16642-01 ATTN:
Mr. Ralph LaGro President 274 East Chicago Street Coldwater, MI 49036 Gentlemen:
This is to acknowledge receipt of your letter dated September 15, 1980, signed by L. Don Pipe, M.D.,
and Ralph LaGro, Administrator, in response to our letter of August 25, 1980.
Paragraph four of our letter dated August 25, 1980 states in part, that we are concerned about your management control system that has permitted the items of noncompliance to occur.
Consequently, you were requested to describe those actions taken or planned to improve the effectiveness of your management control over your liccased activities so as to pre-clude the recurrence of the items of noncompliance.
Your response letter dated September 15, 1980, failed to describe your actions taken or planned, to improve the effectiveness of your manage-ment control.
Enclosed is Appendix B, " Management Control," to provide guidance for your response describing the actions you may use to improve the effectiveness of your management control system-We noted that your response letter dated September 15, 1980 failed to address the subject of corrective action you may have taken or planned, to avoid future noncompliance, nor the date when full compliance will be achieved, for items one through eight in Appendix A of our letter dated August 25, 1980.
Accordingly, in your reply to this letter please des-cribe the corrective action to be taken to avoid recurrence of the items of noncompliance, and the date when full compliance will be achieved, for items one through eight in Appendix A of our letter dated August 25, 1980.
In regard to your question concerning the frequency of isotope committee meetings, the letter received September 25, 1975, signed by L. Don Pipe, M.D.,
described the duties, responsibilities, and the meeting frequency of the isotope committee.
Item 1, F, of the letter mentioned above, states that the isotope committee shall meet quarterly.
If you want to 8010210 389
Community Health Center 10CT a ggg change the isotope meeting frequency, you may apply for a license amend-ment.
Until a specific amendment is approved, you are required to meet quarterly.
License application dated June 17, 1975, signed by Mr. Ralph J. LaGro, Administrator and Lawrence D. Pipe, M.D., states that the method you will use for daily constancy checks of the dose calibrator will include the technetiun-99m, iodine-131 and cesiunr137 settings.
If you feel that the daily constancy checks on the iodine-131 and cesiun-137 set-tings are unnecessary, you may apply for a license amendment to change the daily constancy checks of the dose calibrator.
Until an amendment to change the daily constancy checks of the dose calibrator is approved, you are required to perform daily constancy checks of the dose calibra-tor on the iodine-131 and cesium-137 settings.
In regard to your comments that the inspector arrived unannounced, please be advised that it is our policy to conduct unannounced inspec-tions of programs conducted under licenses issued by the Nuclear Regula-tory Commission.
Thank you for your opinions regarding the regulatory process and the cost effectiveness of our regulations.
A copy c f your letter will be sent to the Director of Nuclear Licensing, Radioisotope Licensing Branch, Washington, D.C.
If you have any questions regarding these matters, please feel free to contact us.
Sincerely,
/' James G. Kepp e Director
Enclosure:
Appendix B, Management Control cc w/ encl:
L. Don Pipe, M.D.,
Chief Radiologist Mr. Neal Dantes, R.T.
Chief Technologist of Nuclear Medicine and Radiology cc w/ enc 1, w/ltr dtd 9/15/80:
Central Files Reproduction Unit NRC 20b PDR NSIC
Appendix B Management Control In order to provide you with some guidance in assessing the adequacy of your management control program, the NRC Region III office provides the following as the acceptance criteria for adequate management control for materials licensees.
" Management Control" is a system instituted by management to assure that licensed activities are performed safely and in accordance with regulatory requirements (license conditions and ap-plicable regulations).
This will include:
Delineation of duties and responsibilities of all persons involved a.
in licensed activities.
b.
Providing for indoctrination and training of all personnel performing licensed activities, specifically in those areas directly affecting compliance with NRC regulations and license conditions.
Verification, as by checking, auditing and inspecting, that activi-c.
ties af fecting saf ety related functions have been correctly performed.
The verifying process should be performed by individuals or groups other than those performing the safety related procedures.
d.
Insuring continued compliance of licensed activities throughout periods during which routine activities may be interrupted, such as changes in equipment, personnel or facilities.
Because of the many variables involved, such as the number of personnel, type of activity being performed and the locaric, or locations where activities are performed, the organizational structure for executing the management control program may take various forms; however, irrespective of the organizational structure, the individual or group responsible for this control should have the flexibility and authority to institute changes or corrections as required to maintain compliance with NRC regu-lations and license conditions.