ML20040F267
| ML20040F267 | |
| Person / Time | |
|---|---|
| Issue date: | 02/03/1982 |
| From: | Wiedeman D NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | |
| Shared Package | |
| ML20040F260 | List: |
| References | |
| NUDOCS 8202090025 | |
| Download: ML20040F267 (3) | |
Text
O Appendix NOTICE OF VIOLATION Illinois Masonic Medical Center License No. 12-02349-05 As a result of the inspection conducted on January 6 and 7,1982, and in accordance with the Interim Enforcement Policy, 45 FR 66754 (October 7, 1980), the following violations were identified:
1.
License Condition No. 17 requires that licensed material be possessed and used in accordance with statements, representation, and procedures contained in application dated January 24, 1979, and letters dated May 2, 1979, and June 24, 1981.
l The above referenced application states the Medical Isotope Committee l
will meet quarterly.
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 Medical Isotope Committee met on July 16, 1979, January 9, 1980, April 16, 1980, and September 17, 1981. These intervals exceed the quarterly requirement.
This is a Severity Level V violation (Supplement VII).
This is a Repeat Item of noncompliance.
2.
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 speci-fied in the product labeling (package insert) shall comply with the labeling regarding:
(i)
Chemical and physical form; (ii)
Route of administration; and, (iii)
Dosage range.
Contrary to the above, it was determined through statements by licensee representatives and the NRC inspectors review of patient log records that this requirement is not being met.
Specifically, in June 1980, and January 1981, two (2) intra-catheterizations of the urinary bladder i
l (cystograms) were performed. Also, during the period July 10, 1980, to October 13, 1980, the licensee performed four injections of technetium-99 into the peritoneal cavity.
These procedures are not described in the manufacturer's package insert as an authorized route of administration.
This is a Severity Level V violation (Supplement VII).
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3.
License Condition.No. 17' requires that licensed material be possessed j
and used in accordance with statements, representation, and procedures contained in application dated January 24, 1981,'and letters dated
.May 2, 1979, and June 24, 1981.
Letter dated May 2, 1979, states when handling Group VI sealed sources all personnel shall be provided with and shall wear TU) ring dosimeters to measure extremity dose.
Contrary to the above requirement, it was determined.through statements by licensee representatives and the NRC inspectors review of. exposure records that this condition is not being met.
Specifically, an indivi-dual performing brachytherapy implants using cesium-137 was not provided with the required TLD ring dosimetry.
This is a Severity Level V violation (Supplement VII).
4.
License Condition No. 17 requires that licensed material be possessed and used in accordance with statements, representation, and procedures May 2, 1979, and June 24, 1981.
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24, 1979, and letters dated contained in application dated January The above referenced application states any individual who at one time handles more than 5 millicuries of unsealed high-specific activity 1
iodine-131 or. iodine-125 shall have the total radioactive iodine content (microcuries) of the thyroid gland measured using' an uptake probe system within 96 hours0.00111 days <br />0.0267 hours <br />1.587302e-4 weeks <br />3.6528e-5 months <br /> after each work period.
Contrary to the above requirement, it was determined through statements by licensee representatives and the NRC inspectors review of patient log records that this condition is not.being met.
Specifically,,on September 1, 1981, a patient was treated with 100 millicuries of liquid iodine-131 -and bioassays were not performed on individuals involved with the administration of this material.
This is a Severity Level V-violation (Supplement VII).
5.
License Condition No. 17 requires that licensed material be possessed and used in accordance with statements, representation, and procedures contained in application dated January 24, 1979, and letters dated May 2, 1979, and June 24, 1981.
The.above referenced application states the dose calibrator will be checked for energy linear response at least quarterly.
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Appendix-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, your dose calibrator was checked for energy. response on July 24, 1979 and September 23, 1981, an interval of more than three months.
This is a Severity Level V violation-(Supplement-VII).
i 6.
License Condition No. 17 requires that licensed material be possessed and'used in accordance with statements, representation, and procedures contained in application dated January 24, 1979 and letters dated May 2, 1979, and June 24, 1981.
The above referenced application states daily smear tests will be made in the nuclear medicine preparation area, and weekly smear tests will be performed in the remaining nuclear medicine department.
Contrary to the above requirement, it was determined through statements by licensee representatives and the NRC inspectors review of survey records that this condition is not being met.
Specifically, a licensee representative stated the above required smear. tests have not been per-e formed since the date of license issuance May 29, 1979.
This is a Severity Level V violation (Supplement VII).
i 7.
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 for all sources received and possessed.
Contrary to the above requirement, a licensee representative stated quarterly physical inventories have not been performed since the date of license issuance May 29, 1979.
This is a Severity Level V violation (Supplement VII).
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Pursuant to the provisions of 10 CFR 2.201, you are required to submit to i
this office within thirty days of the date of this Notice a written state-ment or explanation in reply, including for each item of noncompliance:
1 (1) corrective action taken and the results achieved; (2) corrective action l
to be taken to avoid further noncompliance; and (3) the date when full com-l pliance will be achieved.
Under the authority of Section 182 of the Atomic l
Energy Act 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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Date D./G. Wiedeman, Acting Chief Materials Radiation Protection c
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