ML20217A090
| ML20217A090 | |
| Person / Time | |
|---|---|
| Issue date: | 11/16/1990 |
| From: | Davis A NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | |
| Shared Package | |
| ML20217A079 | List: |
| References | |
| EA-90-172, NUDOCS 9011200177 | |
| Download: ML20217A090 (5) | |
Text
m NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF civil PENALTY West Shore Hospital Docket No. 030-10713 Manistee, Michigan License No.
21-16271-01 EA 90-172 During an NRC inspection conducted on September 27, 1990, violations of NRC requirements were identified.
In accordance with the " General Statement of Policy and Procedure for NRC Enforcement Actions," 10 CFR Part 2 Appendix C (1990), the Nuclear Regulatory Commission proposes to impose a civil penalty pursuant to Section 234 of the Atomic Energy Act of 1954, as amended (Act), 42 U.S.C. 2282, and 10 CFR 2.205. The particular violations and associated civil penalty are set forth below:
A.
10 CFR 35.21(a) requires that the licensee, through the Radiation Safety Officer, ensure that radiation safety activities are being performed in accordance with approved procedures. The licensee's procedures for i
training personnel who work with or in the vicinity of radioactive material l
are described in the application dated August 27, 1980, and were approved by License Condition No. 16.
The application dated August 27, 1980, states in Item 12, " Personnel i
Training Program " that all personnel will receive proper instruction in L
the items specified in 10 CFR 19.12, including: -pertinent NRC regulations, I
I the rules and regulations of the license, and the pertinent terms of the license before assuming their duties or [ work) in the vicinity of radioactive materials.
Contrary to the above, before a technologist assumed duties involving l
radioactive materials during February 1990, the licensee failed to provide j
proper instruction in the items specified in 10 CFR 19.12, including the
' pertinent NRC regulations, the rules and regulations of the license, and the pertinent terms of the license.
r B.
10 CFR'35.21(a) requires that the licensee, through the Radiation Safety ji Of ficer, ensure that radiation safety activities are being performed in l-accordance with approved procedures. The licensee's procedures.for the safe use of radioactive material are described in the application dated ~
August 27, 1980, and were approved by License Condition No. 16.
The application dated August 27, 1980, states in Item 15. " General Rules-p L
for the Safe Use of Radioactive Material " that TLD finger badges will be I
wornduringtheelutionofgenerator[s]andpreparation, assay,and injection of radiopharmaceuticals.
Contrary to-the above, on at least three occasions during the period -
L February 1990 through September 22, 1990, a technologist failed to wear a l
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9011200177 901116 i
fE03 LIC30 F,EgL h
21-16277-01
Notice of Violation TLD finger badge during the elution of molybdenum-99/ technetium-99m generators and during the preparation, assay and injecte., of radiopharmaceuticals.
C.
10 CFR 35.22(a) requires, in pertinent part, that to ettablish a quorum at a-quarterly meeting of the Radiation Safety Conr..ittee and to conduct business, the Radiation Safety Officer must be present.
Contrary to the above, the licensee's Radiation Safety Officer f ailed to attend the meetings of the Radiation Safety Committee held during the first quarters of 1988 and 1989.
D.
10CFR35.50(b)(1)requiresalicenseetocheckeachdosecalibratorfor constancy with a dedicated check source at the beginning of each day of use.
Contrary to the above, the licensee failed to check the dose calibrator for constancy at the beginning of each day of use during the period April 29 through September 22, 1990.
E.
10 CFR 35.50(b)(3) requires a licensee to test each dose calibrator for linearity at least quarterly over the range of its use from the highest dosage that will be administered to a patient and 10 microcuries.
Contrary to the above:
1.
The licensee failed to test the dose calibrator for linearity during the first and fourth quarters of 1989.
L 2.
Since the inception of the requirement on April 1,1987 until the 4:
' inspection on September 27, 1990, dose calibrator linearity tests performed by the licensee failed to test the dose calibrator for
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linearity down to 10 microcuries.
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F.
10 CFR 35.60(c) requires a licensee to use a syringe radiation shield when preparing a radiophannaceutical. kit and to use a syringe radiation shield
-when administering a radiopharmaceutical by injection unless the use of the shield is contraindicated for that patient.
l Contrary to the above, on September 22, 1990, a nuclear medicine technologist failed to use a syringe radiation shield when preparing a radiopharmaceutical kit and administering the radiopharmaceutical by injec-tion, and the use of the syringe radiation shield was not contraindicated
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for that patient.
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G.-
10 CF'R 35.70(a) requires a licensee to survey with a radiation detection i,
survey instrument at _the end of each day of use all areas where L
radiopharmaceuticals are routinely prepared for use or administered.
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e Notice of Violation Contrary to the above, on seven days of use during the period April 29 through September 22, 1990, the licensee did not survey with a radiation detection survey iristrument at the end of each day of use all areas where radiopharmaceuticals were routinely prepared for use or administered.
H.
10 CFR 35.70(e) requires a licensee to survey for removable contamination once each week all areas where radiopharmaceuticals are prepared for use, administered, or stored.
Contrary to the above, during sixteen weeks of use during the period February 22, 1989 through June 15, 1990, the licensee did not survey for removable contamination once each week all areas where radiopharmaceuticals were prepared for use, administered, or stored.
1.
10 CFR 35.200(b) requires a licensee to elute generators and prepare reagent kits in accordance with the manufacturer's instructions. The manufacturer's instructions for the preparation of the Choletec reagent kit used by-the licensee on September 22, 1990, specified that a maximum of 100 m1111 curies of technetium-99m be added into the reaction vial.
10 CFR 35.200(c)(1) allows a licensee to depart from the manufacturer's instruction for eluting generators and preparing reagent kits provided that the licensee has a written directive made by an authorized user physician that directs a specific departure for a particular patient, or patients, or for a radiopharmaceutical, and which includes the specific nature of the departure, a precise description of the departure, and a l
brief statement of the reasons why the departure from the manufacturer's instructions for preparing the radiopharmaceutical would obtain medical results not otherwise attainable or would reduce medical risks to particular patients because of their medical condition.
Contrary to the above, on September 22, 1990, the licensee failed to prepare a Choletec reagent kit in accordance with the manufacturer's instructions and did not have a written directive made by an authorized user physician which directed a specific departure from those instructions.
Specifically, a nuclear medicine technologist added approximately 450 mil 11 curies of technetium-99m to a Choletec reagent kit used to prepare a radiopharmaceutical administered to a patient.
J.
10 CFR 35.204(b) requires a licensee using a molybdenum-99/ technetium-99 generator for preparing a technetium-99m radiopharmaceutical measure the molybdenum-99 concentration in each eluats cr extncti Contrary to the above, on August 18 and September 22, 1990, the licensee failed to measure the molybdenum-99 concentration in each eluate.
L These violations have been categorized in the agsregate as a Severity Level III problem (Supplement VI).
Cumulative Civil Penalty - $4,375 (assessed equally among the 10 violations)..
l 1
Pursuant to the provisions of 10 CFR 2.201, the West Shore Hospital (Licensee) is hereby required to sLbmit a written statement of explanation to the Director.
Office of Enforcement,11.5. Nuclear Regulatory Commission, within 30 days of the date of this Notice of Violation and Propoted imposition of Civil Penalty (Notice). This reply should be cicarly marked as a
- Reply to a Notice of Violation" and should include for each alleged violation:
(1) admission or denial of the alleged violation, (2) the reasons for the violation if admitted, and if denied, the reasons why, (3) the corrective steps 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 compliance is achieved.
If an adequate reply is not received within the time specified in this Notice, an order may be issued to show cause why the license should not be modified, suspended, or revoked or why such other actions as may be proper should not be taken. Consideration may be given to extending the response time for good cause shown.
Under the authority of Section 182 of the Act, 42 U.S.C. 2232, this response shall be submitted under oath or affirmation.
Within the same time as provided for the response required under 10 CFR 2.201, the Licensee may pay the civil penalty by letter addressed to the Director.
Office of Enforcement. U.S. Nuclear Regulatory Comission, with a check, draft, money order, or electronic transfer payable to the Treasurer of the United States in. the amount of the civil penalty proposed above, or may protest imposition of the civil-penalty in whole or in part, by a written answer addressed to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission.
Should the Licensee fail to answer within the time specified, an order imposing the civil penalty will be issued. Should the Licensee elect to file an answer in accordance with 10 CFR 2.205 protesting the civil penalty, in whole or in part, such answer should be clearly marked as an " Answer to a Notice of Violation" as ay:
(1) deny the violations listed in this Notice in whole or in part, (2, vemonstrate 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 perialty in whole or in part, such answer may request remission or mitigation of the penalty.
Section V.B of 10 CFR Part 2. Appendix C (1990)y, the factors addressed in In requesting mitigation of the' proposed penalt, should be addressed.
Any written answer in accordance with 10 CFR 2.205 should be set forth separately
-from the statement or explanation in reply pursuant to 10 CFR 2.201, but may incogortte parts of the 10 CFR 2.201 reply by specific reference (e.g.,
citing page and paragraph numbers) to avoid repetition. The attention of the Licensee 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 subsequently has been. determined 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. 2282c.
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5-L Notice of Violation h-The response noted above (Reply to Notice of Violation, letter with payment of civil penalty, and Answer to a Notice of Violation) should be addressed to:
i Director, Of fice of Enforceme. t. U.S. Nuclear Regulatory Comission. ATTN:
Document Control Desk, Washington, D.C. 20555 with a copy to the Regional Administrator, U.S. Nuclear Regulatory Comission, Region III, 799 Roosevelt Road, Glen Ellyn, Illinois 60137.
c FOR THE NUCLEAR REGULATORY COMMIS$10N
-&Q4 A. Bert avis
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Regional Administrator Dated at Glen Ellyn, Illinois this 16th day of November 1990 i
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