COMPLIANCE INFO 1986 - 2016 - Laserfiche WebLink

Home Browse Search

State of California-Health and Welfare Agency Department of Health Services Page 6 of 9 pages RADIOACTIVE MATERIAL LICENSE License Number: 1276-39 Sup*mentary Sheet Amoandment Number -g 29. Technetium 99m labelled pharmaceuticals prepared by the licensee by aseptic addition of pertechnetate to sterile, pyrogen free reagents may be administered to humans provided the radioassay of the final product is determined with an overall error not exceeding ten percent. When the pharmaceutical is prepared from reagents procured in the form of approved kits, the licensee must strictly follow all instructions and recommendations contained in the package insert information; otherwise the pharmaceutical must be prepared and compounded from a prescription in accordance with the regulations of the California Board of Pharmacy. 30. For a period not to exceed 60 days in any calendar year, a visiting physician is authorized to use licensed materials for human use under the terms of this license, provided the visiting physician: (a) Has the prior written permission of the hospital's Administrator and its Radiation Safety Committee. (b) Is specifically named as a user on an Nuclear Regulatory Commission(NRC)or Agreement State license authorizing human use. (c) Performs only those procedures for which the physician is specifically authorized by the Nuclear Regulatory Commission (NRC) or Agreement State license. The licensee shall maintain for inspection copies of the written permission specified in (a) above and the license(s) specified in (b) and (c) above. These records shall be maintained for five years from the time the licensee grants its permission under (a) above. 31. Equipment for radiometric assay of pharmaceuticals, body fluids, excreta, or in-vitro assay samples shall be calibrated to ensure reliability of data obtained. The stability of the equipment shall be checked at least once each day of use, using appropriate standards. 32. Nuclear medicine technology procedures shall be performed by nuclear medicine technologists pursuant to the California Code of Regulations, Title 17, Subchapter 4.6. Such procedures shall be performed under the supervision of individuals listed as authorized users on this license who meet the criteria specified in Section 30510. Certificates or special permits issued pursuant to Subchapter 4.6 shall be prominently displayed at the facility authorized on this license. 33. Remote afterloading device facilities shall be so constructed as to permit continuous observation of patients from outside the treatment room(s). 34. Written emergency instructions shall be posted conspicuously at the remote afterloading device control(s). Instnrctions shall include directions for manually turning off the remote afterloading device(s), removing the patient,securing the rooms)against unauthorized entry,and notifying the responsible physician or the radiation safety officer. 35. If there is a reason to suspect that the source position indicator or entrance-door(s) interlock(s) is/are not fimnctiortmg properly,use of the remote afterloading device(s)shall be discontinued until the condition has been corrected. A record of any such malfunction shall be made and maintained available for inspection.