ML20009C250
| ML20009C250 | |
| Person / Time | |
|---|---|
| Issue date: | 06/30/1981 |
| From: | Riedlinger B NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV) |
| To: | |
| Shared Package | |
| ML20009C246 | List: |
| References | |
| NUDOCS 8107200409 | |
| Download: ML20009C250 (4) | |
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APPENDIX A NOTICE OF VIOLATION Dept. of Health, Education and Welfare License No. 46-09750-02 Dept. of U. S. Public Health Service Hospital Post Office Box 3145 Seattle, Washington 98114 As a result of the inspection conducted on May 26-28, 1981, and in accordance with the Interim Enforcement Policy, 45 FR 66754 (October 7,1980), the following violations were identified:
A.
10 CFR 20.202(a)(1) states that each licensee shall require the use of personnel monitoring equipment by each individual who is likely to receive a dose in excess of 25 percent of the applicable value specified in paragraph (a) uf 10 CFR 20.101.
Also, Item 11, " Requirement for Film Badges and Finger Dosimeters" of the Radiation Safety Plan dated September 2,1977, which was submitted as a supplement to the license application, states that, "Any individual who is entering a restricted area and is likely to receive a dose in excess of the MPE (Section 9, Subsection I) must obtain and wear a film badge and/or ring dosimeter."
Contrary to the abcve requirements, a nuclear medicine technician who frequently handled radiopharmaceuticals during 1979, 1980 and 1981 and could have received a de e to the hands and forearms in excess of 25% of the applicable vaiue specified in oaragraph (a) of 10 CFR 20.101, stated on May 26, 1981 that he does not routinely wear the finger ring dosimeter when handling radiopharmaceuticals.
This is a Severity Level IV Violation (Supplement IV).
B.
10 CFR 20.203(b) states that each radiation area shall be conspicuously posted with a sign or signs bearing the radiation caution symbol and the words, " Caution Radiation Area".
l Contrary to the above requirement, a dose rate of 5 mr/hr was measured i
by the inspector at the edge of a work area in the Nuclear Medicine Laboratory (Room 211 of the USPHS Hospital). This area had not been po ted as a radiation area.
In a shielded, but accessible space near this area, which was used to store syringes which had been used in nuclear medicine procedures, the inspector measured a dose rate of j
40 mr/hr.
This is a Severity Level IV Violation (Supplement IV).
l C.
License Condition 12. requires that radiopharmaceuticals and materials listed in Groups I, II and III of 10 CFR 35.100 and iodine 131 for treatment of hyperthyroidism, cardiac dysfunction and thyroid carcinoma may be used by or under the supervision of Drs. Robert J. Griep or William B. Nelp.
8107200409 810630 NMS LIC30 46-09750-02 PDR
. Contrary to this requirement, during the absence of Drs. Griep and Nelp, 291 millicuries of technetium-99m were administered to 17 patients 4
between June 23 and 27, 1980. These nuclear medicine procedures were approved by physicians not named on the-license.
This is a Severity Level IV Violation (Supplement VII).
D.
License Condition 15. states that the licensee shall possess and use licensed material in accordance with statements, representations, and procedures centained in application dated December 29, 1976; letters dated June 30,1977, July 1,1977, July 12,1977 and Septemoer 2, 1977; letter with enclosures dated April 1,1981; and ALARA Program contained in Appendix 0 of Regulatory Guide 10.8 (Revision 1), dated October 1980.
1.
Item 1, entitled " Radiation Safety (RSC) and Medical Isotope i
Committee" of the Radiation Safety Plan dated September 2,1977, which was submitted as a supplement to the license application, with a letter on the same date, states:
"The Radiation Safety Committee shall meet four times each year and additional times as necessary.
... Minutes and records from 1:
this meeting will be kept and copies forwarded to the Hospital l
Di rector. "
Contrary to the above requirements, an examination of the Radiation Safety Committee minutes for the years 1979 and 1980 showed that the committee met only on October 22, 1979-and September 12, 1980.
1 This is a Severity Level IV Violation (Supplement VII).
2.
Item 2, entitled " Radiation Protection Officer" of the Radiation Safety Plan dated September 2,1977 which was submitted as a suppl cent to the license application, states that the hospital Radiation l
Protection Officer, "will conduct inspections and instrument surveys at regular intervals necessary to demonstrate compliance.
... Routine inspection data will be subnitted in summary for annual l
review."
Contrary t the above requirements, no inspections and instrument surveys were conducted by the Radiation Protection Officer during the period of June 5,1978 to January 8,1981.
This is a Severity Level IV Violation (Supplcment VII).
i 3.
Item 14, entitled " Area Surveys" of the Radiation Safety Plan dated September 2, 1977 which was submitted as a supplement to the license application, states that each area where radioactive material is used shall be surveyed each week and the results of l
the survey will be recorded.
l
.. Contrary to the above requirements, during the period of June 5, 1978 to May 26, 1981, surveys of the huclear Medicine Laboratory, Room 211, had not been conducted on the required weekly frequency.
Surveys were conducted on the following dates:
7-7-78, 8-4-78, 12-1-78, 6-20-80, 8-22-80, 9-5-80, 11-28-80, 1-13-81, 1-27-81, 2-5-81, 2-20-81, 3-5-81, 3-16-81, 3-26-81, 5-4-81 and 5-19-81.
This is a Severity Level V Violation (Supplement VII).
4.
Item 18, entitled " Instrument Calibration" of the Radiation Safety Plan dated September 2,1977 which was submitted as a supplement to the license application, states that instrument accuracy and linearity checks of the dose calibrator will be conducted annually and after instrument repair or adjustment.
a.
Contrary to the above requirement, no linearity check of the dose calibrator was conducted during the period October 18, 1977 to April 7,1980.
b.
Contrary to the above requirement, no accuracy check of dose calibrator was conducted during the period June 5,1978 to April 7,1980.
These items constitute a Severity Level IV Violation (Supplement VII).
E.
10 CFR 30.3 states. "no person shall manufacture, produce, transfer, receive, acquire, cwn, possess, or use byproduct material except as authorized in a specific or general license issued pursuant to the regulations in this chapter". NRC License 46-09750-02 issued to the USPHS Hospital, Seattle, Washington, on July 13, 1978 authorized the possession of radioactive materials for certain nuclear medicine procedures.
Contrary to the above requirements, between December 16, 1980 and May 20, 1981, radioactive materials which were possessed by the hospital were used for laboratory research which was not specifically authorized by the license.
Amendment 1 to NRC License 46-09750-02 was issued on May 20, 1981.
This amendment authorizes certain uses for research activities.
This is a Severity Level IV Violation (Supplement VII).
Pursuant to the provisions of 10 CFR 2.201, the U. S. Public Health Service Hospit:1, Seattle, Washington 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:
(1) the corrective steps which have been taken and the results achieved; (2) corrective steps which will be taken to avoid
.... further items of noncompliance; and (3) the date when full compliance will 4
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 affirmation.
Consideration may be given to extending your response time for good cause shown.
j dated June 30, 1981 N O, I df M, B. A. Riedlinger,gadiation Specialist 1
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