ML20010E160
| ML20010E160 | |
| Person / Time | |
|---|---|
| Issue date: | 08/21/1981 |
| From: | Greger L NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | |
| Shared Package | |
| ML20010E161 | List: |
| References | |
| NUDOCS 8109030157 | |
| Download: ML20010E160 (5) | |
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Appendix A NOTICE OF VIOLATION Fayette County Hospital License No. 12-10678-01 License No. 12-10678-02 l
As a result of the inspection conducted on August 4, 1981, and in accordance l
with the Interim Enforcement Policy, 45 FR 66754 (October 7, 1980), the i
following violations were identified:
1.
License Condition No. 15 requires that licensed material be possessed and used in accordance with statements, representations, and procedures contained in application dated June 22, 1978.
The above referenced application states that the procedures described in Appendix B of the draf t " Guide for Preparation of Applications for Medical Programs" dated November 1977 will be followed. Appendix B states that the Medical Isotopes Committee will meet at least quarterly and records of the meetings vill be available for inspection.
Contrary to the.ibove requirements, it was determined through statements by licensee representatives that this condition is not being met.
Speci-fically, a licersee representative stated that meetings are held annually, and records of the meetings were not available for review.
This is a Feverity Level V violation (Supplement VII).
2.
License Condition No. 15 requires that licensed material be possessed and used in accord: ce with statements, representations, and procedures contained in applit n dated June 22, 1978.
The above referenced application states that the procedures described in Appendix D of the draft " Guide for Preparation of Applications for Medical Programs" dated November 1977 will be followed. Appendix D, Section 2 states, the dos:- calibrator must be checked for accurate operation at the time of installation and periodically tLereaf ter. The following checks are required:
(1) geometrical variation at installation, (2) linearity quarterly, (3) constancy daily.
Contrary to the above requirements, it was determined through statements by licensee representatives and the NRC inspectors' review of records that this condition is not being met.
Specifically, (1) a geometrical variation check has not been performed as of the date of this inspection; (2) line-l arity checks were performed on November 28, 1979, April 15, 1980, and i
8109030157 810825 NMS LIC30 12-10678-01 PDR
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Appendix A !
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January 7, 1981, periods of more than three months; (3) constancy checks i
were not performed on August 3 and 4, 1981, dates when patient doses were prepared.
This is Severity Level V violation (Supplemenu VII).
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3.
License Condition Nr. 15 requires that licensed material be possessed and used ir. accordance with statements, representations, and procedures j
contained in application dated June 2?. 1978.
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i Item No. 13 of the referenced application states shipments of byproduct I
material received during of f-duty hours are received by the Nursing i
Supervisor, who directs the transport to nuclear medicine where the ship-ment is placol behind the lead shield on the hot lab work bench and the area is re-locked.
Contrary to the above requirements, it was determined through statements l
by licensee representatives that this condition is not being met.
Speci-fically, a licensee representative stated, generators delivered during off-duty hours are placed in the hallway nutside the nuclear medicine department by the carrier.
This is a Severity Level 'l violation (Supplement VII).
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10 CFR 20.201(b) requires that you make such surveys as may be necessary j
for you to comply with all sections of Part 20.
As defined in 10 CFR i
20.201(a), " Survey" means an evaluation of the radiation hazards incident to the oteduction, use, release, disposal, or presence of radioactive materials or other sources of radiation under a specific set of conditions.
Contrary to the above, due to the inoperable condition of your survey meters, you failed to make adequate surveys as were necessary to assure j
compliance with 10 CFR Part 20, and Condition No. 15 of your license.
Specifically, (1) you failed to perfora adequate surveys of packages containing byproduct material at the surface and three feet; (2) you failed to perform adequate daily and weekly surveys of the nuclear l
medicine department.
This is a Severity Level V violation (Supplement IV).
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5.
License Condition No. 15 requires that licensed material be possessed and used in accordance with statements, representations, and procedures contained in application dated June 22, 1978.
The above referenced application states the procedures described in Appendix G of the draft " Guide for Preparation of Applications for l
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Appendix A,
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Medical Program" dated November 1977 will be followed. Appendix G 3
states, the technologist shall survey hands and clothing after each
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preparation or before leaving the hot lab area.
Contrary to the above requirement, it was determined through statements by licensee representatives and the NRC inspectors' review of records l
l that this condition is not being met.
Specifically, a licensee repre-a sentative stated, personnel surveys were not performed between June 19, 1981, to the date of this inspection.
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i This is a Severity Level V violation (Supplement VII).
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6.
10 CFR 19.12 requires that you instruct all individuals working in your restricted areas in the applicable provisions of the Commission's regulations and your license requirement.
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Contrary to this requirement, on the day of the inspection, individuals who were working in your restricted area had not bet 3 instructed in the applicable provisions of the regulations and the cor 'itions of your l
License, including your procedure for performing dese calibrator con-L stancy checks.
J This is a Severity Level V violation (Supplement VII).
7.
10 CFR 20.401(h) requires that you maintain records showing the results of surveys that you made to assure compliance with 10 CFR 20.201(b)
" Surveys."
Contrary to the above, you failed to maintain records of results of such surveys as were necessary to assure compliance with 10 CFR 20.301, a regulation that describes authorized means of disposing of licensti l
material contained in waste.
Specifically, the Nuclear Medicine Department failed to maintain records of surveys of radioctive waste to assures that no measureable radiation above background was present prior to disposal as normal trash.
This is a Severity Level VI violation (Supplement IV).
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8.
License No. 12-01678-02 10 CFR Part 35 requires full calibrations and spot checks of teletherapy t
units, be perfc rmed in accordance with the procedures recommended by the i
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Scientific Committee on Radiation Dosimetry of the American Association of Physicists in Medicine.
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Contrary to the above requirement, it was determined through stater"mt s i
by licensee representatives and the NRC inspectors review of recort T
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Appendix A
-4 this condition is not being met.
Specifically, as part of your monthy spot check, timer accuracy is being determined by comparing the console timer t.o a stopwatch.
This is a Severity Level V violation (Supplement VII).
9.
10 CFR 35.25 requires the licensee to maintain calibration records of instrument s used to make full calibration measurements of teletherapy units and records of the licensee's evaluation of the qualified experts training and experience.
Contrary to the above requirement, it was determined through statements by licensee representatives that this condition is not being met.
Spec-ifically, on the day of this inspection, the above records were not available for review.
This is a Severity Level VI violation (Supplement VII).
Pursuant to the provisions of 10 CFR 2.201, you are required to submit to this office within thirty days of the date of this Notice a written statement or explanation in reply, including for each item of noncompliance:
(1) cor-rective action taken and the results achieved; (2) corrective action to be taken to avoid further noncompliance; and (3) the date when full compliance will be achieved.
Under the authority of Section 182 of the Atomic Energy Tct of 1954, as amended, this response shall be submitted under oath or affirmation. Consideration may be given to extending your response time for good cause shown.
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f Dated h dl [ _
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I L. R. Gr ege, Acting Chicil Tech ita l Inspection Branch
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s Appendix B q
Mana cenen t Con t rol i
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l In o rde r to provide you with some guidance in assessing the adequacy of i
l your management cont rol p rogram, the NRC Region III of fice provides the followf ng as the acceptance criteria for adequate management control for ma te rials licensees.
""anagement Control" is a system instituted by i
managemen t to assure that licensed activities are performed safely and in
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acco rdance with regulatory requirements (license cc,nditions and applicable re gul at ions ),
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This will include :
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Delineativ of duties and responsibilitier of all persons involved in licensed activities.
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Providing for indoctrination and training of all personnel performing licensed activities, specifically in those areas directly af fecting compliance with NRC regulations and license conditions.
c.
Verification, as by checking;, auditing and inspecting, that activi-ties af fecting safety related functions have been correctly perforred.
The verifying process should be performed by individuals or grouna other than those pe rforming the safety re] ited procedures.
d.
Insuring continued compliance of licensed activities throughout periods during wnich routine activities may be interrupted, such l
as changes in equipment personnel or facilities.
Because of the many variables involved, such as the number of personnel, l
type of activity being perforned and the location or locations where activit ies are pe rfo rmed, the organizational structure for executing the management cont rol program may take various forms ; however, i rrespe c tive l
of the organizational structure, the individual or group responsible fo r this control should have the flexibility and authority to institute changes or corrections as required to naintain compliance with NRC reau-lations and license conditions.
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