skip to main content
OSTI.GOV title logo U.S. Department of Energy
Office of Scientific and Technical Information

Title: Pilot program to assess proposed basic quality assurance requirements in the medical use of byproduct materials

Abstract

In January 1990, the Nuclear Regulatory Commission (NRC) proposed amendments to 10 CFR Part 35 that would require medical licensees using byproduct material to establish and implement a basic quality assurance program. A 60-day real-world trial of the proposed rules was initiated to obtain information beyond that generally found through standard public comment procedures. Volunteers from randomly selected institutions had opportunities to review the details of the proposed regulations and to implement these rules on a daily basis during the trial. The participating institutions were then asked to evaluate the proposed regulations based on their personal experiences. The pilot project sought to determine whether medical institutions could develop written quality assurance programs that would meet the eight performance-based objectives of proposed Section 35.35. In addition, the NRC wanted to learn from these volunteers if they had any recommendations on how the rule could be revised to minimized its cost and to clarify its objectives without decreasing its effectiveness. It was found that licensees could develop acceptable QA programs under a performance-based approach, that most licensee programs did meet the proposed objectives, and that most written QA plans would require consultations with NRC or Agreement State personnel before they would fullymore » meet all objectives of proposed Section 35.35. This report describes the overall pilot program. The methodology used to select and assemble the group of participating licensees is presented. The various workshops and evaluation questionnaires are discussed, and detailed findings are presented. 7 refs.« less

Authors:
; ;  [1]
  1. Brookhaven National Lab., Upton, NY (United States)
Publication Date:
Research Org.:
Nuclear Regulatory Commission, Washington, DC (United States). Div. of Regulatory Applications
Sponsoring Org.:
USNRC; Nuclear Regulatory Commission, Washington, DC (United States)
OSTI Identifier:
5932949
Report Number(s):
NUREG/CR-5798; BNL-NUREG-52303
ON: TI92001867
DOE Contract Number:  
AC02-76CH00016
Resource Type:
Technical Report
Country of Publication:
United States
Language:
English
Subject:
62 RADIOLOGY AND NUCLEAR MEDICINE; BY-PRODUCTS; QUALITY ASSURANCE; REGULATIONS; MEDICAL ESTABLISHMENTS; TESTING; DIAGNOSTIC TECHNIQUES; HEALTH SERVICES; MEDICAL PERSONNEL; NUCLEAR MEDICINE; RADIOISOTOPES; STANDARDIZATION; US NRC; ISOTOPES; MEDICINE; NATIONAL ORGANIZATIONS; PERSONNEL; SOCIAL SERVICES; US ORGANIZATIONS; 550600* - Medicine

Citation Formats

Kaplan, E, Nelson, K, and Meinhold, C B. Pilot program to assess proposed basic quality assurance requirements in the medical use of byproduct materials. United States: N. p., 1991. Web. doi:10.2172/5932949.
Kaplan, E, Nelson, K, & Meinhold, C B. Pilot program to assess proposed basic quality assurance requirements in the medical use of byproduct materials. United States. https://doi.org/10.2172/5932949
Kaplan, E, Nelson, K, and Meinhold, C B. 1991. "Pilot program to assess proposed basic quality assurance requirements in the medical use of byproduct materials". United States. https://doi.org/10.2172/5932949. https://www.osti.gov/servlets/purl/5932949.
@article{osti_5932949,
title = {Pilot program to assess proposed basic quality assurance requirements in the medical use of byproduct materials},
author = {Kaplan, E and Nelson, K and Meinhold, C B},
abstractNote = {In January 1990, the Nuclear Regulatory Commission (NRC) proposed amendments to 10 CFR Part 35 that would require medical licensees using byproduct material to establish and implement a basic quality assurance program. A 60-day real-world trial of the proposed rules was initiated to obtain information beyond that generally found through standard public comment procedures. Volunteers from randomly selected institutions had opportunities to review the details of the proposed regulations and to implement these rules on a daily basis during the trial. The participating institutions were then asked to evaluate the proposed regulations based on their personal experiences. The pilot project sought to determine whether medical institutions could develop written quality assurance programs that would meet the eight performance-based objectives of proposed Section 35.35. In addition, the NRC wanted to learn from these volunteers if they had any recommendations on how the rule could be revised to minimized its cost and to clarify its objectives without decreasing its effectiveness. It was found that licensees could develop acceptable QA programs under a performance-based approach, that most licensee programs did meet the proposed objectives, and that most written QA plans would require consultations with NRC or Agreement State personnel before they would fully meet all objectives of proposed Section 35.35. This report describes the overall pilot program. The methodology used to select and assemble the group of participating licensees is presented. The various workshops and evaluation questionnaires are discussed, and detailed findings are presented. 7 refs.},
doi = {10.2172/5932949},
url = {https://www.osti.gov/biblio/5932949}, journal = {},
number = ,
volume = ,
place = {United States},
year = {1991},
month = {10}
}