ML19276F771
| ML19276F771 | |
| Person / Time | |
|---|---|
| Issue date: | 04/05/1979 |
| From: | NRC OFFICE OF INSPECTION & ENFORCEMENT (IE) |
| To: | |
| Shared Package | |
| ML19276F768 | List: |
| References | |
| FOIA-80-341 NUDOCS 7904120082 | |
| Download: ML19276F771 (3) | |
Text
.
E~
_ Appendix A NOTICE OF VIOLATION Nuclear Pharmacy, Inc.
License No. 12-18044-OlMD Based on the inspection conducted on January 31 and February 2, 1979, it appears that certain of your activities were in noncompliance with NRC requirements, as noted below.
Items 1 through 5 are infractions, and items 6 and 7 are deficiencies.
1.
Condition 16 of your license requires that all radioactive gases as free gas or in solution be procured from a supplier who dis-tributes the product indicated for human use in accordance with the Federal Food, Drug, and Cosmetic Act.
Contrary to the above, between October 12, 1978 and January 12, 1979, you procured a total of seven bulk shipments of xenon-133 gas from a supplier who did not distribute the product indicated for human use in accordance with the Federal Food, Drug, and Cosmetic Act, but who distributed the product marked "Not for Human Use."
2.
Condition 12 of License No. 12-18044-OlMD specifies that licensed material shall be used by, or under the supervision of, Robert Lee Sanchez, Richard D. Sakasitz, Jon Michael Reavis, or Richard Sheriff.
Contrary to this requirement, none of the four individuals named in your license supervised the use of licensed material at your facility from January 3, 1979 through the date of this inspection.
3.
10 CFR 20.201(b), " Surveys," requires you to make such surveys as may be necessary for you to comply with all sections of Part 20.
Contrary to this requirement, a review of your bioassay data indicated that your bioassay procedure was not sufficiently sensitive to detect the 40 MPC Hour control point required by 10 CFR 20.103(a)(1) for the entire period of time between samples. Specifically, your thyroid bioassays were conducted 7904120tDW?[
Appendix A at 30 day intervals and your bioassay procedure was calculated to have a minimum detectable activity equivalent to 14.6, 52.4 and 188 MPC hours at 0, 15 and 30 days following uptake.
This noncom-pliance is directly related to radiological working conditions.
4.
10 CFR 20.103(a)(3) requires in part, the licensee to use suitable measurements of conc.entrations of radioactive materials in air for detecting and evaluating airborne radioactivity in restricted areas.
Contrary to the above, as of the date of this inspection, you had no program to measure airborne concentrations of radioactive materials in air in restricted areas.
This noncompliance is directly related to radiological working conditions.
5.
10 CFR 20.201(b), " Surveys," requires you to make such surveys as may be necessary for you to comply with all sections of Part 20.
Contrary to this requirement, as of the date of this inspection, you failed to make such surveys as were necessary to assure compliance with 10 CFR 20.106, " Concentrations in effluents to unrestricted areas," a regulation that limits the yearly average concentration of iodine and xenon contained in the air discharged to the unrestricted area.
Specifically, no evaluations were made of the concentration of iodine discharged from your Elmhurst facility.
6.
Condition 15 of your license requires that licensed material be possessed and used in accordance with statements, representations, and procedures contained in your application dated January 12, 1978 and in several letters, one of which was dated April 14, 1978.
Contrary to the above, monthly bioassay tests for thyroid uptake of radiciodine were performed from November 1978 through January 1979 in your Elmhurst laboratory rather than by the hospital and medical center which you specified in Paragraph 4 of your April 14, 1978 letter.
This noncompliance is directly related to radio-logical working conditons.
7.
10 CFR 30.41(b)(5), " Transfer of byproduct material" requires that byproduct material be transferred to a person authorized to receive such material under terms of a specific license or
Appendix A a general license issued by the Commission or an agreement state.
10 CFR 30.41(c) requires that, prior to transferring licensed material, you verify that the transferee's license authorizes the receipt of the type, form, cud quantity of byproduct material to be transferred.
10 CFR 30.41(d) specifies acceptable methods for such verification.
Contrary to this requirement, on at least eight occasions, you transferred byproduct material to a transferee who your records indicated held a license which had expired without utilizing one of the specified verification procedures to determine the licensing status of the transferee.
e