ML20032E677
| ML20032E677 | |
| Person / Time | |
|---|---|
| Issue date: | 11/12/1981 |
| From: | James Keppler NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | Lagra R COMMUNITY HEALTH CENTER OF BRANCH COUNTY, COLDWATER |
| Shared Package | |
| ML20032E678 | List: |
| References | |
| NUDOCS 8111200802 | |
| Download: ML20032E677 (2) | |
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Community Health Center License No. 21-16642-01 ATTN:
Mr. Ralph LaGro President 274 East Chicago Street Coldwater, M1 49036 Gentlemen:
This is to acknowledge receipt of ycur letters dated September 15, 1980 and April 20, 1981, informing us of the steps you have taken to correct the items of noncompliance and your desire to amend the requirements of your license.
This letter also refers to the telephone conversation between you and Mr. W. P. Reichhold of this office concerning your corrective actions.
It is our understanding your corrective actions will include the following:
1.
Isotope Committee meetings will be held quarterly until a specific amendment to change the meeting frequency is approved.
2.
Daily constancy checks of the dose calibrator will be performed on the settings which correspond to the isotopes which you will use that day.
3.
You will document your methods of management control which will prevent the recurrence of noncompliance.
If our understanding of the above is incorrect, please contact William P. Reichhold or Donald J. Sreniawski at (312) 932-2500.
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If our understanding of the above is correct, no response to this letter is required.
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Community Health Center NOV121981 You may contact Bruce Mallett, Ph.D., Section Leader of the Region III Licensing Section at (312) 932-2500 for information concerning amendments.
Sincerely, Original cloned by Jc. ras G. Keppler James G. Keppler Director cc:
L. Don Pipe, M.D., Chief Radiologist Mr. Neal Dantes, R.T., Chief Technologist of Nuclear Medicine and Radiology Bruce Mallett, Ph.D.
Section Leader, Region III Licensing Section, Material Licensing Branch, Division of Fuel Cycle and Material Safety cc w/ltrs dtd 9/15/80 & 4/20/81:
DMB/ Document Control Desk (RIDS)
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COMMUNITY,%/4 CENTER Of [3Panch COUnly COLDWATER, MICl!!GAN 49036 TEL: 517 278 - 7361 September 15, 1980 Mr. Jarres G. Keppler Director U. S. Nuclear Regulatory Commission Region lli 739 Roosevelt Road Glen ElIyn, IIIinois 60137 Regarding notice of violations of Licensee No. 21-16642-01
Dear Sir:
Since ray arrival at this Institution five years ago it has been obvious that the Nuclear'Hedicine portion of the diagnostic imaging services has been quite weak.
Continuing attempts have been made to upgrade the level of service here. Within the past six months or so several major changes have been made which should effect Irv rovement in this service:
1.
The equipment in.use previously was a dual probe scanner.
Early this' year we acquired an Ohio Nuclear game camera. This not only produces a superior product, but its versatliity makes the position more challenging to the Nuclear Medicine technologist.
2.
The Nuclear Medicine technologist position likewise has been upgraded by a recent increase in salary.
3 The Nuclear Medicine Department itself has been physically moved from a position on the far side of the hospital up three stories to a position immediately adjacent to the Radiology Department.
The above changes _have made it possible to attract a much enore fg/
qualified Individual to the position of Nuclear Medical technologist, and hopefully will result in a higher level of service from that Individual. TH
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insofar as the. violations themselves, following are specific responses:
1.
Isotope corraittee meetings currently are in compliance, in DUPE of B&' ' ' #
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g be documented, if you feel that committee meetings should
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b' Personally, I do not f' eel that my patients can af ford the 4
luxury of having the committee meet without a reason for meeting.
2.
Daily checks on the TechneIlum 99n setting on the dose 1'
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calibrator are and shall be made and documented.
Since V
(]wedonot utilize any other Isotope except on rare occasions.
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we feel that other checks done routinely present our patients
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also with an unnecessary cost burden.
If you feel that this sf apparently unnecessary activity should be continued, plea 3e let me know ar.d it will be ef fected and the appropriate persons notified. Monthly linearity checks of the dose calibrator are
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and shall be performed and graphed.
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3 Wipe tests and surveys'are and shall be performed and documented.',
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4.
We are currently in compliance in that our survey meter was S e-calibrated within the past 12 months. Annual calibration will -
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Regarding GM surveys, your records note that we are in compliance.
d We shall continue to survey. The wipe tests are being and shall be performed and documented. - t " 6
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R. S. Landauer film badge service have been notified and the D
required information is and shall be recorded. - p. c4
[7 The required documents are 'and shall be posted.
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The required serveys of decayed material undergoing disposal - P 0
as normal trash are and shall be performed and recorded.
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l would like to take this opportunity to express n.y concern with your caicept of the regulatory process as evidenced by our recent inspe ct ion.
First of all, it appears as though your approach mainly disregards the cost effective application of your relgulations.
It was impossible for me to elicit any concern for cost ef fectiveness from your inspector.
Certainly
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COMMUNITY S0/4 CENTER Of Ol'ilDCb COUnly COLDWATER, MICll:GAN 49036 TEL: 517 - 278 7361 Page 3 this is a most important concern today, but the concept seemed foreign to him.
Your inspector arrived unannounced and stated that he could work alone.
However, his continued questioning and understandable inability to find and interpret the document: necessary to the inspection absorbed about 31 hours3.587963e-4 days <br />0.00861 hours <br />5.125661e-5 weeks <br />1.17955e-5 months <br /> of time from the Radiologist's schedule, and five hours of time each from the Chief Technologist and Nuclear Medicine technologist.
51nce we do have a fixed work load to accomplish, this produces severe strain on our ability to attend to the details necessary to provide our patients with a good Imaging service. The potential for injury imposed by this unnecessary stress far exceeds that essociated with the relatively minor license violations uncovered by your investigator. Unfortunately you cannot really weigh the inplications of the violations related to my specific situation.
If you could, I believe that you would agree that-your inspector severely limited his ef fectiveness by strict literal application of your regulations, it would have been much more beneficial to my patients and hospital personnel if he could have applied the broader. concepts which are only outlined by i
the regulations.
Possibly his inability to do this reflects a department wide losecurity developed since THl.
If so, it.is most unfortunate.
As a professional diagnostic radiologist, my chief concern is to derive a nuximum of diagnostic information at a minimum of cost. This l
Includes cost in both financial resources and also in radiation exposure to patient and personnel.
Insofar as the reDulatory process furthers this l
cffort, It is weicome. When It makes this goal core dif ficut t to attain, l
It is my obligation to try to improve the process itself.
Si cerely 4 i-A L. Don Pipe, M.D.
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Ralph La o Administrator l
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