IR 05000628/2008008
| ML20135H551 | |
| Person / Time | |
|---|---|
| Site: | 03003137, 05000628 |
| Issue date: | 09/16/1985 |
| From: | Murley T NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| To: | |
| Shared Package | |
| ML20135H550 | List: |
| References | |
| EA-85-098, EA-85-98, NUDOCS 8509240002 | |
| Download: ML20135H551 (5) | |
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AND PROPOSED IMPOSITION OF CIVIL PENALTY
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l Metro Health Center
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Docket No. 030-03137
Erie, Pennsylvania 16501 License No. 37-11258-01 EA 85-98
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i An NRC inspection of activities authorized under NRC License No. 37-11258-01
was conducted on August 8, 1985.
During the inspection, twelve violations of
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NRC requirements were identified.
In accordance with the " General Statement of Policy and Procedure for NRC Enforcement Actions," 10 CFR Part 2, Appendix C
(1985), the Nuclear Regulatory Commission proposes to impose a civil penalty
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pursuant to Section 234 of the Atomic Energy Act of 1984, as amended ("Act"),
l 42 U.S.C. 2282, PL 96-295, and 10 CFR 2.205. The particular violations
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and the associated civil penalty are set forth below:
A.
10 CFR 20.207(a) requires that licensed materials stored in an unrestricted
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
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10 CFR 20.3(a)(17), an unrestricted area is any area access to which is
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not controlled by the licensee for the purpose of protection of individuals
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from exposure to radiation and radioactive materials.
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Contrary to the above, during weekends for the time period of June 28, 1985 l
to August 8,1985, licensed quantities of technetium-99m/ molybdenum-99 i
contained in nuclear generators were routinely stored in an unlocked
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portable lead-lined box in an unlocked room in the emergency room center, and during those times, constant surveillance of the licensed material
was not maintained.
i B.
Condition 17 of License No. 37-11258-01 requires that licensed material
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be possessed and used in accordance with statements, representations and
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procedures contained in the application dated August 6, 1982, and Appendix 0 j
of Regulatory Guide 10.8.
1.
Item 10 of the application requires that the licensee possess'an
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operable isotope dose calibrator and that if the activity displayed varies from the stated assay of the standard source by greater than
15%, arrangements will be made for the immediate repair or adjustment
of the dose calibrator.
I Contrary to the above, as of August 8,1985', the only dose calibrator
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possessed by the licensee had been functioning erratically for sev-eral months and routinely showed variations greater than 1100% of the
l stated assay, and as of August 8, 1985, arrangements had not been
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made for the repair or adjustment of the calibrator.
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2.
Item 10.8.3.b of the application requires that each day the dose cali-brator is used, it be tested for constancy on all isotope settings i
with a cesium-137 standard.
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Contrary to the above, a.
The dose calibrator was used during October 1984, but a constancy check was not performed on the days used; b.
The dose calibrator was used regularly between January 1 to July i
1, 1985, but constancy tests were only performed for 16 days during this period; and
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c.
The dose calibrator was used on July 1, 2, 3, 5, 15, and 30 and on August 7, 1985, but constancy checks were not performed on those days.
3.
Item 10.A of the application requires that all survey meters be cali-brated annually, and that no survey meter be used beyond the anniversary date of its last successful calibration.
Contrary to the above, as of August 8, 1985, the high level survey'
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i meter, a Victoreen 740F, S/N 2207, had not been calibrated since its last successful calibration, June 13, 1984.
4.
Item 9 of this application requires that the licensee possess an operable Victoreen CDV-700 low-level survey meter or its equivalent.
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Contrary to the above, from February to June 19, 1985, the licensee l
did not possess an operable Victoreen CDV-700 low-level survey meter, i
nor its equivalent.
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5.
Item 7 of this application requires that the Radiation Safety
Committee meet not less than quarterly to conduct its business.
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Contrary to the above, between May 1984 and July 30, 1985, the
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Radiation Safety Committee did not meet.
i 6.
Appendix 0, Item 1.b requires the licensee Radiation Safety-Committee (RSC) to annually review the entire radiation safety program, in-
'cluding ALARA considerations.
Contrary to the above, the RSC did not meet to review the entire radiation safety program, including ALARA considerations,_ for the year 1984.
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Item 17 of this application ~ requires that surveys be performed in accordance with the " Survey Procedures" contained in'the application
dated August 6, 1982.
Item A of " Survey Procedures" requires daily radiation surveys of all elution, preparation and injection areas.
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Item D of " Survey Procedures" requires weekly G-M meter surveys and i
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contamination wipe tests to be conducted in all laboratory areas.
Contrary to the above,
a.
Between February 1985 and August 8,1985, daily radiation sur-
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J veys of elution, preparation and injection areas had not been
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conducted;
l b.
Between November 30, 1984 and July 31, 1985, weekly G-M meter surveys and wipe tests were not performed in any of the laboratory
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areas;
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c.
During the week of July 31, 1985 wipe tests were not performed; and d.
As of August 8,1985, surveys or wipe tests had not been con-
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j ducted in the~ cardiac imaging room where millicurie quantities i
of technetium-99m are used.
j 8.
Item 15.3 of this application requires that individuals who prepare i
doses of radiopharmaceuticals monitor their hands after each proce-
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dure and before leaving for the day.
t Contrary to the above, from February to July 1985, Nuclear Medicine
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technologists routinely failed to conduct personnel monitoring of their hands and clothing after each procedure and before leaving for j
the day.
9.
Item 14 of this application requires that packages containing radio-
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active material be opened in 'accordance with the procedures in Appendix F of Regulatory Guide 10.8, Revision 1.
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Steps 2.c, 2.d and 2.f of Appendix F require that, when opening i
pack ~ ages in which licensed material has been received, the exposure j
rate 3 feet from'the surface of the package, and at the surface, be measured and recorded, and that the external surface of the final'
i source container be wiped with a moistened cotton swab, held with
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forceps, and the cotton swab be assayed and the results recorded t
Contrary to the above, for packages received between February
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through July 1985, none of the procedures specified in Appendix F,
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Steps 2.c, 2.d and 2.f were followed.
In addition, surveys of packages received from August 1-8, 1985 did not include a wipe of the final source container for a contamination check, t
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Notice of' Violation-4-
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J 10.
Item 15 of this application requires that radioactive material be
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used in accordance with the " General Rules for Safe Use of Radio-
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active Materials" contained in Appendix G of Regulatory Guide 10.8.
Item 6.a of Appendix G requires that each patient dose be assayed in the dose calibrator prior to administration.
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Contrary to the above, on four occasions on March 7 and on three l
occasions on April 15, 1985, patient doses were not assayed in the
dose calibrator prior to administration.
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C.
License Condition 16.B requires the licensee to monitor radioactive trash
1 prior to disposal in the normal trash to demonstrate that radiation levels are at background level.
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Contrary to the above, radioactive trash disposed in the normal trash from
October 17, 1983 to February 22, 1985 was not monitored prior to disposal to demonstrate that' radiation levels were at background level.
Collectively, these violations have been categorized as a Severity Level III problem (Supplements IV and VI).
Cumulative Civil Penalty'- $3,750 assessed equally among the violations.
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Pursuant to the provisions of 10 CFR 2.201, the Metro Health Center is hereby required to submit to the Director, Office of Inspection and Enforcement, i
USNRC, Washington, D.C.
20555, with a copy to this office, within 30 i
days of the date of this Notice, a written explanation or statement in reply,
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including for each alleged violation: (1) admission or denial of the alleged violation, (2) the reasons for the violation, if admitted, (3)' corrective steps
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that have been taken and the results achieved, (4) the corrective steps that
will be taken to avoid further violations, and, (5) the date when full com-pliance will be achieved.
If an adequate reply is not received within the time specified in this Notice, the Director, Office of Inspection and Enforcement, may issue an order to show cause why the license should not be modified, j
suspended, or revoked or why such other action as may be proper should not be i
taken. Conside' ration may be given to extending the response time for good
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cause shown. Under the authority of Section 182 of the Act, 42 U.S.C. 2232, j
this response shall be submitted under oath or affirmation.
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Notice of Violation-5-Within the same time as provided for the response required above under 10 CFR 2.201, Metro Health Center may pay the civil penalty by letter addressed to the Director, Office of Inspection and Enforcement, with a check, draft, or money order payable to the Treasurer of the United States in the cumulative amount of Three Thousand Seven Hundred Fifty Dollars ($3,750)
or may protest imposition of the civil penalty in whole or in part by a written answer addressed to the Director, Office of Inspection and Enforcement.
Should Metro Health Center fail to answer within the time specified, the Director, Office of Inspection and Enforcement, will issue an order imposing the civil penalty in the amount proposed above.
Should Metro Health Center elect to file an answer in accordance with 10 CFR 2.205 protesting the civil penalty, such answer may:
(1) deny the violation listed in this Notice in whole or in part, (2) demonstrate extenuating circumstances, (3) show error in this Notice, or (4) show other reasons why the penalty should not be imposed.
In addition to protesting the civil penalty in whole or in part, such answer may request remission or mitigation of the penalty.
In requesting mitigation of the proposed penalty, the five factors addressed in Section V.B of 10 CFR Part 2, Appendix C should be addressed. Any written answer in accordance with 10 CFR 2.205 should be set forth separately frcm the statement or explanation in reply pursuant to 10 CFR 2.201 but may incorporate parts of the 10 CFR 2.201 reply by specific reference (e.g., citing page and paragraph numbers) to avoid repetition.
Metro Health Center's attention is directed to the other provisions of 10 CFR 2.205, regarding the procedure for imposing a civil penalty.
Upon failure to pay any civil penalty due, which has been subsequently deter-mined in accordance with the applicable provisions of 10 CFR 2.205, this matter may be referred to the Attorney General, and the penalty, unless compromised, remitted, or mitigated, may be collected by civil action pursuant to Section 234c of the Act, 42 U.S.C. 2282.
FOR THE NUCLEAR REGULATORY COMMISSION Origrnal s!Rned by Thor.as E. Murley Thomas E. Murley Regional Administrator Dated a King of Prussia, Pennsylvania this/l/
ay of September 1985 0FFICIAL RECORD COPY CP PKG OSTEOPATHIC 3 - 0009.0.0 08/26/85