ML20050D562
| ML20050D562 | |
| Person / Time | |
|---|---|
| Issue date: | 04/07/1982 |
| From: | Warnick R NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | |
| Shared Package | |
| ML20050D559 | List: |
| References | |
| 30-12831-80-01, 30-12831-80-1, 30-14386-80-02, 30-14386-80-03, 30-14386-80-2, 30-14386-80-3, 30-15125-80-02, 30-15125-80-03, 30-15125-80-04, 30-15125-80-2, 30-15125-80-3, 30-15125-80-4, NUDOCS 8204120320 | |
| Download: ML20050D562 (4) | |
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4 Appendix NOTICE OF VIOLATION Nuclear Pharmacy Incorporated Wauwatosa, Wisconsin License No. 48-17466-01MD Chicago, Illinois License No. 12-18044-01MD Philadelphia, Pennsylvania License No. 37-18461-01MD Based on investigations and inspections conducted from May 1, 1980, to October 19, 1981, at your Chicago, Illinois; Wauwatosa, Wisconsin; and Philadelphia, Pennsylvania Pharmacies, it appears that certain of your activities were in noncompliance with NRC requirements as noted below.
1.
Wauwatosa, Wisconsin - Report No. 30-12831/80-01 10 CFR 20.103(a)(3) requires that the licensee use suitable measurements of the concentration of radioactive material in air for detecting and evaluating any airborne radioactivity in restricted areas and in addi-tion, as appropriate, to use measurements of radioactivity excreted from the body in order to make a timely detection and assessment of individual intakes by exposed individuals.
Contrary to this requirement, from June 1977 to June 1980, records of bioassays performed indicated the name, date of bioassay, background count per minute and thyroid count per minute. No information relating to the efficiency of the counting system was available, nor was any conversion made from counts per minute to microcuries/cc air or MPC hours. Without this information an evaluation to determine compliance with 10 CFR 20.103(a)(3) cannot be made.
This infraction was corrected as if June 1980; therefore, no response is required.
This is an infraction (See Exhibit B, Paragraph 10(b)).
2.
Philadelphia, Pennsylvania - Report No. 30-15125/80-03 & 30-15125/80-04 In a letter dated February 14, 1979, the licensee stated that the guide lines of NRC Regulatory Guide 8.20 would be followed with regard to performing bioassays for I-131 and I-125.
NRC Regulatory Guide 8.20 recommends that bioassays be performed every two weeks.
Contrary to the above, from October 30, 1979, to January 17, 1980, bioassays were not performed for three individuals, nor for seven individuals during the period November 29, 1979, to January 17, 1980.
In addition, bi-weekly samples were not evaluated during one employee's initial three months of employment.
8204120320 820407 NMS LIC30 12-18044-01MD PDR l
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4 This is an infraction (See Investigation Report, Paragraph 3.11, and Exhibit C, Paragraph 10(a)).
3.
Philadelphia, Pennsylvania - Report No. 30-15125/80-02 & 30-15125/80-04
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License Condition 20 requires that licensed material be possessed, used, packaged, labeled, and distributed in accordance with statements, repre-sentations, and procedures contained in application dated November 6, 1978, and letters dated February 14 and 19, March 12 and 15, July 11, August 6, and September 10, 1979, and January 25, 1980.
(1) Item I.a.2, "Radiopharmaceutical Log Control Sheet," attached to your application dated November 6, 1978, requires that radiopharmaceuticals bear a proper label identifying the radiopharmaceutical dispensed.
Contrary to this requirement, on December 10, 1979, Macro-aggregated human serum albumin containing technetium-99m was dispensed with a label reading sulphur colloid (technetium-99m).
This is an infraction (See Investigation Report, Paragraph 3.17, and Exhibit D, Paragraph III.D.3).
4.
Philadelphia, Pennsylvania - Report No. 30-15125/80-02 Items B.2, B.3, and B.6, of the licensee's document titled " Radiation Protection Program" attached to the licensee's application dated November 6, 1978, requires that the licensee monitor and wipe test incoming packages for radiation levels and removable contamination.
Contrary to this requirement, as of May 1980, the licensee failed to monitor or wipe test incoming packages from customers for radiation levels and removable contamination.
This is an infraction (See Exhibit D, Paragraph III.D.2).
5.
Philadelphia, Pennsylvania - Report No. 30-15125/80-02 Item 7 of the licensee's letter dated February 14, 1979, requires that pocket dosimeters be calibrated on a six month basis.
I Contrary to this requirement, as of May 1580, the licensee failed to calibrate pocket dosimeters for a period in excess of eight months.
This is an infraction (See Exhibit D, Paragraph III.F.4).
6.
Philadelphia, Pennsylvania - Report No. 3>15125/80-03 License Condition No. 20 requires that licensed material be used in accordance with Statements, representations and procedure listed in application dated November 6, 1978. Appendix D of that application specifies procedures to be followed for dose calibrator linearity tests.
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Contrary to Appendix D, Item I.C.1, attached to the application dated November 6, 1978, it was determined that no linearity test had been performed between May 30, 1980 and September 16, 1980, a period greater than one calendar quarter.
This is an infraction (See E daoit C, Section 11) 7.
Philadelphia, Pennsylvania - Report No. 30-15125/80-03 & 30-15125/80-04 Chicago, Illinois - Report No. 30-14386/80-02 & 30-14386/80-03 10 CFR 19.12 requires, in part, that the licensee instruct all individuals working in or frequenting a restricted area in the precautions and pro-cedures to minimize exposure to radioactive materials.
Contrary to the above, prior to March 1980 and June 1980, the cleaning personnel who frequented the restricted area of the Chicago and Philadelphia laboratories, respectively, were not trained in the pre-cautions and procedures to minimize exposure to radioactive materials.
This is an infraction (See Investigation Report, Paragraph 3.5, Exhibit A, Paragraph 5, and Exhibit C, Paragraph 5).
8.
Philadelphia, Pennsylvania - Report No. 30-15125/80-04 Chicago, Illinois - Report No. 14386/80-03 10 CFR 20.201(b) requires that each licensee make or cause to be made surveys (evaluations) that may be necessary to assure compliance with the regulations of Part 20.
l Contrary to the above, the licensee failed to make certain surveys (evaulations) to assure compliance with 10 CFR 20.101(a) and 20.202(a)(1).
Specifically, prior to September 16, 1980, the licensee failed to evaluate the radiation exposure to cleaning personnel fre-quenting restricted areas in the Chicago and Philadelphia laboratories and failed to determine if personnel monitoring devices were required.
This is an infraction (See Investigation Report, Paragraph 3.5).
9.
Philadelphia, Pennsylvania - Report No. 30-15125/80-03 & 30-15125/80-04 10 CFR 20.102(a) requires each licensee to maintain for any individual, 6
prior to that individual's first entry into the licensee's restricted area a written signed statement, either:
(1) that the individual had no prior occupational dose during the current quarter, or (2) the nature and amount of any occupational dose which the individual may l
have received during the specifically identified current calendar quarter from sources of radiation possessed or controlled by other j
persons.
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Appendix 4
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Contrary to the above, it was determined that in 1979 a part-time laboratory employee was allowed to work in a restricted area without a current exposure history having first been established from the employee's personal monitoring data collected at another NRC licensed facility.
This is an infraction (See Investigation Report, Paragraph 3.10, and Exhibit C, Paragraph 9).
10.
Chicago, Illinois - Report No. 30-14386/80-02 10 CFR 20.401(a) requires each licensee to maintain records showing the radiation exposures of all individuals for whom personnel monitoring is required under 20.201, i
Contrary to the above, on the day of the inspection, new exposure records did not contain an individual's extremity overexposure dose of 21,821 millirem received between October 11, 1979, and December 1, 1979.
This is a deficiency (See Exhibit A, Paragraph 9).
Pursuant to the provisions of 10 CFR 2.201, you are required to submit to 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) corrective action taken and the results achieved; (2) corrective action to be taken to avoid further noncompliance; and (3) the date when full com-pliance was achieved. Consideration may be given to extending your response time for good cause shown.
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