ML20033A816
| ML20033A816 | |
| Person / Time | |
|---|---|
| Issue date: | 11/20/1981 |
| From: | Norelius C NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | |
| Shared Package | |
| ML20033A812 | List: |
| References | |
| NUDOCS 8111270312 | |
| Download: ML20033A816 (6) | |
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Appendix A NOTICE OF VIOLATION Jackson County Schneck Memorial License No. 13-05605-01 Hospital As a result of the inspection conducted on October 20, 1981, and in accord-ance with the Interim Enforcement Policy, 45 FR 66754 (October 7, 1980), the following violations were identified:
1.
10 CFR 20.105(b) requires that radiation levels in unrestricted areas be limited so that if an individual were contiauously present in the area, he could not receive a dose in excess of 2 millirems in any hour or 100 millirems in any seven consecutive days.
Contrary to this requirement, on October 20, 1981, radiation levels existed on the outside wall of your hot lab, in the hallway (an unre-stricted area) of such magnitude that if an individual had been continuously present in the area, he could have received a dose in excess of 2 millirems in any one hour. Specifically, the radiation was 12 mR/hr at the wall and 3 mR/hr at 18 inches from the wall.
This is a Severity Level IV violation (Supplement IV).
2.
10 CFR 20.207(a) requires that licensed materials stored in an unre-stricted area be secured against unauthorized removal from the place of storage.
10 CFR 20.207(b) requires that materials not in storage be under constant surveillance and immediate control of the licensee.
As defined in 10 CFR 20.3a(17), an unrestricted area is any area access to which is not controlled by the licensee for purposes of protection of individuals from exposure to radiation and radioactive materials.
Contrary to this requirement, on the day of the inspection, your xenon-133 trapping device was located in the hallway (an unrestricted area) by the nuclear medicine imaging room. Moreover, the radiation level at the surface of the trap was 2 mR/hr and the device was not secured against unauthorized removal nor was it in your immediate control.
This is a Severity Level IV violation (Supplement IV).
3.
License Condition No. 16 requires that licensed material be possessed and used in accordance with statements, representations, and procedures contained in applications dated June 30 and November 21, 1977.
Item No. 4 of Addendum 4 of the above referenced applications states that the Medical Isotope Committee will meet at least quarterly for the purpose of reviewing current usage of radioactive materials.
l g2811120 13-05605-01 PDR
Appendix A Contrary to the above requirement, it was determined through statements by licensee representatives and the NRC inspectors review of records that this condition is not being met.
Specifically, as of the date of this inspection, Medical Isotope Committee meetings were held on February 20, 1980 and May 1, 1979, at intervals in excess of a quarter.
This is a Severity Level V violation (Supplement VII).
4.
License Condition No. 16 requires that licensed material be possessed and used in accordance with statements, representations, and procedures contained in applications dated June 30 and November 21, 1977.
Item No. 14 of Addendum 4 of the above referenced applications states a complete radiation protection survey of the nuclear medicine section will be performed by a consultang nuclear medicine physicist approximately every six months.
Contrary to the above requirement, it was determined through statements by licensee representatives that this condition is not being met.
Spec-ifically, a licensee representative stated the above surveys have not been performed since the date of this license renewal in 1978.
This is a Severity Level V violation (Supplement VII).
5.
License Condition No. 16 requires that licensed material be possessed and used in accordance with statements, representations, and procedures contained in applications dated June 30 and November 21, 1977 and letter dated July 18, 1978.
The " Procedures for Opening Packages Cs ntaining Radioactive Material" in Addendum 4 of the above referenced applications states that all packages will be surveyed for radioactive contamination with a GM meter prior to opening and the results of the survey will be recorded.
Contrary to the above requirement, it was determined through statements by licensee representatives and the NRC inspectors review of records that this condition is not being met.
Specifically, the last package survey was performed and recorded on July 27, 1981, and there have been receipts of radioactive materials each week since that date.
This is a Severity Level V violation (Supplement VII).
6.
10 CFR 35.14(e)(1)(i) requires each licensee who possesses sealed sources as calibration or reference sources shall perform tests for leakage and/or contamination at intervals not to exceed six months.
Contrary to this requirements, a licensee representative stated leak tests on your 201 microcurie cesium-137 and 234 microcurie barium-133 sealed sources have not been performed since the date of this license renewal in 1978.
This is a Severity level V violation (Supplement VII).
Appendix A 7.
License Condition No. 16 requires that licensed material be possessed and used in accordance with statements, representations, and procedures contained in applications dated June 20 and November 21,'1977.
s Item No. 15 of Addendum 4 of the above referenced applications states that Xe-133 will be stored behind lead bricks in a properly labelled hood in the chemistry lab.
Contrary to the above requirement, it was determined.through statements.
by licensee representatives that this condition is not.being met.
Spec-ifically, a licensee representative stated that Xe-133 unit doses were stored without a ventilation hood in the hot lab, an area not authorized by this license for such storage.
This is a Severity Level V violation (Supplement VII).
8.
License Condition No. 16 requires that licensed material be possessed and used in accordance with statements, representations, and procedures contained in applications dated June 30 and November 21, 1977.
Item No. 11 of Addendum 3 of the above referenced applications states your survey meters will be checked daily with a check source for proper function and calibrated annually.
Contrary to the above requirement, it was determined through statements by licensee representatives and the NRC inspectors' review of records that this condition is not being met.
Specifically, a licensee representative stated daily survey meter checks bave not been performed and the Texas Nuclear survey meter was last calxorated about two years ago.
This is a Severity Level V violation (Supplement VII).
9.
License Condition No. 16 requires that licensed material be possessed and used in accordance with statements, representations, and procedures contained in applications dated June 30 and November 21, 1977.
Item No. 10 of the above referenced applications, Addendum 2, states a low level GM survey meter would be available at your facility.
Contrary to the above requirement, it was determined through state-ments by licensee representatives that this condition is not being met.
Specifically, a licensee representative stated your Atomic Products Corporation GM survey meter has been in for repairs for over one year.
A replacement low level survey meter has not been available at your facility for over one year.
In addition, your Nuclear Texas Model 9121 was not operable on the day of inspection.
This is a Severity Level V violation (Supplement VII).
Appendix A 10.
License Condition No. 16 requires that licensed material be possessed and used in accordance with statements, representations, and procedures contained in applications dated June 30 and November 21, 1977, and letter dated July 18, 1978.
Letter dated July 18, 1977, states your dose calibrator will be checked daily for constancy using cobalt-57, barium-133 and cesium-137. Also, Item No. 11 of Addendum 3 in the above referenced applications states your dose calibrator will be checked annually for linearity.
?
Contrary to the above requirement, it was determined through statements by licensee representatives and the NRC inspectors review of records that this condition is not being met.
Specifically, a licensee representative stated linearity tests have not been performed since the date of the last inspection.
In addition, the daily constancy checks are not being per-formed with the above required reference sources.
This is a Severity Level V violation (Supplement VII).
11.
License Condition No. 16 cequires that licensed material be possessed and used in accordance with statements, representations, and procedures contained in applications dated June 30 and November 21, 1977.
Item No. 14 of Addendum 4 of the above referenced applications, states elution and dose preparation areas will be directly surveyed daily and other laboratory areas where radioactive materials are used will be surveyed weekly with wipe tests, as well as by direct survey.
Contrary to the above requirement, it was determined through statements by licensee representatives and the NRC inspectors review of records that these conditions were not being met.
Specifically, the last survey of the elution/ dose preparation area was done on August 7, 1980, the last weekly survey of other laboratory areas was done on December 15, 1979, and the last wipe test was done on November 1, 1978.
This is a Severity Level V violation (Supplement VII).
12.
10 CFR 35.14(f)(2) requires each licensee who possesses and uses calibration or reference sources shall conduct a quarterly physical inventory to account fer all sources received and possessed.
Records of the inventories shall be maintained for inspection by the Commission.
Contrary to the above requirement, a licensee representative performed periodic inventories, but the required records of these inventories have not been maintained since the date of the last inspection, January 18, 1977.
This is a Severity Level VI violation (Supplement VII).
Appendix A 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 Act of 1954, as amended, this response shall be submitted under oath or a f firmation. - Consideration may be given to extending your response time for good cause shown.
fl0V 2 01991 ff [ q u.f.c Dated C' E. Norelius, Director Division of Engineering and Technical Inspection em
a 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 man-agement to assure that licensed activities are performed safely and in accordance with regulatory requirements (license conditions and applicable regulations).
This will include:
a.
Delineation of duties and responsibilities of all persons involved 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.
c.
Verification, as by checking, auditing and inspecting, that activities affecting safety 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 irsolved, such as the number of personnel, type of activity being performed and the location or locations where ac-tivities are performed, the organizational structure for executing the management control program may take various froms; however, irrespective of the organizational structure, the individual or group responsible for this ccatrol shoula have the flexibility and authority to institute changes or corrections as required to maintain compliance with NRC regulations and license conditions.
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