ML20004C420
| ML20004C420 | |
| Person / Time | |
|---|---|
| Issue date: | 06/01/1981 |
| From: | Stello V NRC OFFICE OF INSPECTION & ENFORCEMENT (IE) |
| To: | |
| Shared Package | |
| ML20004C408 | List: |
| References | |
| EA-81-048, EA-81-48, NUDOCS 8106040035 | |
| Download: ML20004C420 (3) | |
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Appendix A NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTIES Grandview Hospital-License No. 34-06904-01 Dayton, Ohio EA 81-48
.As a result of the investigation conducted on November 12-14, 1980, the following items of noncompliance were -identified.
I The NRC proposes to impose civil penalties pursuant to Section 234 of the Atomic Energy Act of 1954, as amended (42 USC 2282) and 10 CFR 2.205 in the amounts set forth below for the following items.
A.
10 CFR 35.14(b)(6) requires that for Groups I, II and III any licensee using byproduct material for clinical procedures other than those specified in the. product labeling (package insert) shall comply with the product labeling regarding:
(1)
Chemical and physical form; (ii).
Route of administration; and, (iii)
Dosage range.
The Mallinckrodt Diagnostics package insert for the Ultra-TechneKow (Technetium-99m Generator) states, " Sodium pertechnetate Tc-99m is usually administered in intravascular injection but may be given orally."
1.
Contrary to this requirement, during the period ~ February 11, 1980, to September 9, 1980, the licensee performed 183 intra-arterial catheterizatior.s of the coronary arteries with technetium-99m.
This procedure is not described in the manufacturer's package insert as an authorized route of administration.
This is an infraction (Civil Penalty - $500) 2.
Contrary to this requirement, during the period February 9, 1980, to September 9, 1980, the licensee performed four injections of tech-netium-99m into the peritoneal cavity.
This procedure is not des-cribed in the manufacturer's package insert as' an authorized route of administration.
l This is an infraction (Civil Penalty - $500) i
'II No civil penalties are proposed for the following items.
l l
.B.
License Condition 12 requires that licensed material is authorized for t
l_
use by, or under the supervision of, specifically named individuals.
0 i
8106040
4
)
i Appendix A (Continued).
Contrary to the em e, an individual not named on the license'and not-supervised by a licensed named individual, performed a therapeutic procedure on November 5,~1980, using phosphorous-32 for intraplural
-cavity treatment.
This is an infraction.
C.
License Condition 18 requires that the licensee shall possess and use licensed material in accordance with statements, representations,.and orecedures contained.in application dated October 30, 1978.
Appendix K of the above referenced application, " Procedures for Use; of Groups IV and V Radiopharmaceuticals for Treatment of Patients",
Item 11.f states that attending personnel must wear rubber or' dis-
.posable plastic gloves when handling urinals, bedpans, emesis basins or other containers having any material obtained from the body of the patient.
Contrary to the above, a nurse did not wear gloves on August 16-18, 1980, while collecting and disposing of excreta from a patient who had received a therapy dose of 150 millicuries of iodine-131 on August 15, 1980.
This is an infraction.
2.
Appendix F of the above referenced application, " Procedures for Opening Packages Containing Radioactive Material," Items 2 and 3,.
states that the licensee measure the exposure rate at three feet from the package surface and record and measure' surface exposure rate and record.
Contrary to the above, no surveys were performed on packages received af ter July 16, 1979.
This is in infraction.
3.
Appendix B of the above referenced application, " Medical Isotope Committee" states that the Medical Isotope Committee shall meet as often as necessary to conduct its business, but not less than once
!0 in each quarter.
Contrary to the above, the Medical Isotope Committee did not meet during the period April 19,.1978, to July 1979, an interval in excess of a calender quarter.
This is an infraction.
..E
~ Appendix A (Continued) ~
Pursuant.to the provisions of 10 CFR 2.201, Grandview Hospital is hereby 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) admission or cenial of the alleged item of noncompliance; (2) the reasons for the item of noncompliance if admitted; (3) the. corrective steps which have been taken and the results achieved; (4) corrective steps which will'be taken to avoid further noncompliance; and (5) the date when full compliance will be achieved.
Considerition may be given to extending your response time for good cause shown.
U~ der the authority of Section 182 of the Atomic Energy Act of 1954, as amended, this response shall be submitted under oath or affirtuation.
Within the same time period as provided for the response _ required above under 10 CFR 2.201, Grandview Hospital may pay the civil penalties in the cumulative amount of One Thousard Dollars or may protest the imposition of the civil penalties in whole or in part by a written answer.
Should Grandview Hospital
' fail to answer within the time specified, this office will issue an order imposing thi civil penalties in the amount proposed above.
Should Grandview Hospital elect to file an answer protesting the civil pentsties, such answer i
may:
(1) deny the items of noncompliance listed in the Notice of Violation in I
whole or in part; (2) demonstrate extenuating circumstances; (3) show error in the Notice of Violation; or (4) show other reasons why the penalties should not be, imposed.
In addition to protesting the civil penalties in whole or in part, l
such answer may request remission or mitigation of the penalties.
Any written answer in accordance with 10 CFR 2.205 should be set forth separately from your statement or explanation in reply pursuant to~10 CFR 2.201,-but may incorporate by specific reference (e.g., giving page and paragraph numbers) to l
avoid repetition.
Grandview Hospital's attention is directed to the other l
provisions of 10 CFR 2.205 regarding the procedure for imposing civil
[
penalties.
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Upon failure to pay any civil penalty due whic. has been subsequently l
determined in accordance with the applicable provisions of 10 CFR 2.205, the 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 Atomic Energy Act of 1954, as amended, (42 USC 2282).
l k'
Victor Stell)o, Jr., Director
(
Office of Inspection and Enforcement
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