Regulatory Guide 8.18
| ML003739543 | |
| Person / Time | |
|---|---|
| Issue date: | 10/31/1982 |
| From: | Office of Nuclear Regulatory Research |
| To: | |
| References | |
| RG-8.18 | |
| Download: ML003739543 (15) | |
Revision 1 U.S. NUCLEAR REGULATORY COMMISSION October 1982
).REGULATORY GUIDE
-F
OFFICE OF NUCLEAR REGULATORY RESEARCH
REGULATORY GUIDE 8.18 liNJFORMATIOiN RELEVANT TO EiNSURING THAT
OCCUPATIONAL RADIATION EXPOSURES AT MEL)ICAL INSTITUTIONS
,rILL BE AS LOW AS ,IEASONAdLY ACHIEVABLE
A. INTRODUCTION
information useful for radiation protection programs in medical institutions. Sections of the report are keyed to the Paragraph 20.1(c) of 10 CFR Part 20, "Standards for section numbers of this guide for the reader's convenience.
Protection Against Radiation," states that licensees should make every reasonable effort to keep radiation exposures, This guide is generally directed toward occupational as well as releases of radioactive material to unrestricted health protection. However, in a medical institution, certain areas, as far below the limits specified in that part as persons other than employees are exposed to radiation reasonably achievable. Regulatory Guide 8.10, "Operating from NRC-licensed radioactive material. These persons Philosophy for Maintaining Occupational Radiation Expo include visitors as well as patients other than those being sures As Low As Is Reasonably Achievable," sets forth the treated with radioactive material. Protection of these philosophy and general management policies and programs individuals is also addressed in this guide. The content of that licensees should follow to achieve this objective of this guide is also applicable to veterinary medical institu maintaining radiation exposures to employees "as low as is tions insofar as specific diagnostic or therapeutic proce C reasonably achievable" (ALARA). Regulatory Guide 10.8, dures are performed. Similar protection practices are Guide for the Preparation of Applications for Medical applicable for keeping employee and visitor exposures Programs," includes information on an acceptable manage ALARA, whether the patients are animal or human.
ment program for keeping exposures ALARA, as well as specific examples of radiation safety programs and practices Specific guidance regarding radioactive materials in acceptable to the NRC licensing staff. These examples effluents to unrestricted areas is beyond the scope of this supplement the general outline of principles and practices guide. This topic is mentioned only in connection with contained in this guide and in an associated report, actions that influence both occupational exposure and NUREG-0267, "Principles and Practices for Keeping effluent control. Further details on this subject are given in Occupational Radiation Exposures at Medical Institutions Regulatory Guide 10.8. In addition, this guide and theI
As Low As Reasonably Achievable" (Ref. 1). associated report (Ref. I) deal only with radioactive mate rials subject to licensing by the Nuclear Regulatory Com This guide is directed specifically toward medical mission. The regulations and recommendations of other licensees and recommends methods acceptable to the NRC agencies should be consulted in regard to controlling staff for maintaining occupational exposures ALARA in radiation exposures from x-ray machines, other radiation medical institutions. NUREG-0267 is a compendium of emitting equipment, and materials not licensed by NRC.
good practices and helpful information derived from the experience of the, radiological and health physics profes
B. DISCUSSION
sions and is not to be construed in any way as additional regulatory requirements of the Nuclear Regulatory The principle of maintaining occupational radiation expo Commission. In fact, many of the suggestions made in the sures ALARA is an extension of an original recommenda report are based on accepted health protection practices tion of the National Committee on Radiation Protection not specifically addressed in NRC regulations. NUREG-0267 (now the National Council on Radiation Protection and also provides a reference list that may be used for background Measurements (NCRP)) in its 1 9 4 9 report (published in 1954 information on radiation protection science and philosophy, as Report No. 17 (Ref. 2)). In this early report, the NCRP
radiation protection standards, and planning and design introduced the philosophy of assuming that any radiation
"Lines indicate substantive changes from previous issue. exposure may carry some risk and recommended that USNRC REGULATORY GUIDES Comments should be sent to the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555.
Regulatory Guides are Issued to describe and make available to the Attention: Docketing and Service Branch.
Public metho*s acceptable to the NRC staff of implemn4tIng speclfic parts of the Commission's regulations, to delineate tech The guides are issued in the fOllOwing ten broad divisions:
niouess used by the staff in evaluating specific problems or postu lated accIdents, or to provide guidance to appllcantsL Regulatory 1. Power Reactors 6. Products Guides are no? substitutes for regulations, and compliance with 2. Research and Test Reactors 7. Transportation them Is not required. Methods and solutions different from those set 3. Fuels and Materials Facilities 8. Occupational Health Out In the guides will be acceptable if they provide a basis for the 4. Environmental and Siting 9. Antitrust and Financial Review findings requisite to the issuance or continuance of a permit or S. Materials and Plant Protection 10. General license by the Commission.
Copies of issued guides may be purchased at the current Government This guide was issued after consideration of comments received from Printing Office Price. A subscription service for future guides in sDe the Public. Comments and suggestions for improvements in these cific divisions is available through the Government Printing Office.
guides are encouraged at all times, and guides will be revised, as Information on the subscription service and current GPO prices may appropriate, to accommodate comments and to reflect new lnlormn be obtained by writing the U.S. Nuclear Regulatory Commission, tion or experience. Washington. D.C. 20555. Attention: Publications Sales Manager.
radiation exposure be kept Lit a level "as low as practicable'"
(currently referred to as "ALARA"} e. Delegation of sufficient authority hcloo tihe recouI to the Radiation mended maximum permissible dose Safety Officer 3 (RSO) to enforce regulations equivalent. Similar and admin recommendations to keep exposures istrative policies regarding radiation safety: and ALARA have been included in NCRP reports (Ref. 3), as well asin recoinmenda tions of the National Academy of f. Administrative direction to ensure Sciences-National that any new Research Council (Ref. 4). the Federal hospital facilities or equipment thiat Radiation Council may affect radiation (Ref. 5), and other independent scientific protection will be planned or designed and professional in consultation with organizations (Refs. 6-8). The basic radiation the RSO.
protection philosophy of these recommendations has been incorporated in regulations and guides of the -A mkicdL' prugraii lor inleiinel'.nt Nuclear Regulatory 1! 1i1lls Hdl~aCC1'"
pni*losOpný is prL",cnrL-Ld IM -\:*lt;
Commission. ix () it) *eelditor\
Guide I0.N.
This guide and the associated report provide a supple 2. RADIATION SAFETY OFFICE
ment for medical institutions to the FUNCTIONS
basic philosophy of Regulatory Guide 8.10, which lists for all specific licensees the types of management commitments The term "Radiation Safety Office"
and radiation is used here only to protection prograns that would help to indicate that some entity should achieve the objective be established to direct of maintaining occupational exposures and coordinate administrative aspects ALARA. This guide, of the radiation Regulatory Guide 8.10, and Regulatory safety program. The extent of Guide 10.8 will be this program should be used as a basis for evaluating license commensurate with potential radiation applications and protection problems.
radiation safety programs of NRC-licensed medical institu tions, unless the licensee proposes an alternative 2.1 Staffing and Organizational Requirements method of complying with specified portions of the Commission's A sample outline of the various tasks regulations. of a typical Radia tion Safety Office is presented in the appendix. The time I
C. REGULATORY POSITION
and effort required for each of the listed with the size of the medical institution tasks vary widely and the nature and extent ot radioactive material usage. Management A licensee's radiation safety program will te considered (I) should in compliance with the 10 CFR Part 20 review the staffing requirements for each ALARA require of these tasks and ment and in accord with the ALARA provide the necessary personnel to establish philosophy if the and carry out major principles and practices identified radiation safety program requirements and below are adopted (2) should evalu and implemented as part of the institution's ate them on an annual basis.
policies and programs.
2.2 Radiation Safety Personnel Qualifications I. MANAGEMENT PHILOSOPHY AND
ORGANIZATION
Management should select radiation safety personnel The radiation protection responsibility appropriate to the radiation safety program of licensee after careful management] at a medical institution is review of the nature of the program and to maintain expo the extent of sures ALARA for employees, visitors, students, effort and expertise required to carry out and patients the tasks noted in who do not receive radiation or radioactive the appendix.
materials as part of their hospital care. This responsibility should be carried
2.3 Space and Equipment out by means of:
I
a. Information and policy statements 2 The Radiation Safety Office should nave adequate to tne medical equipment and space in appropriate locations and hospital staff; to carry out the following functions:
b. Periodic management audit of operational efforts to a. Maintain, repair, and perform electronic maintain exposures ALARA; calibrations on radiation safety equipment.
c. Continuing management evaluation of radiation b. Calibrate in radiation fields radiation safety staffing, program, and budget requirements; safety and survey equipment (and check the calibrations of other d. Management programs to ensure hospital radiation sources if radiation that all staff and safety and medical employees who may be exposed to radiation physics functions are combined).
receive appro priate briefings and training in radiation safety, including c. Stock radiation safety supplies for labeling.
ALARA concepts: surveying.
decontamination, and personnel protection I*Management" is defined here as and monitoring.
the charter of the medical institution those persons authorized by 3 to make its policies and direct The title "'Radiation Safety its activities. Officer,"
2 Licensees, is used in this gude to designate used by many medical Policy statements should who is responmble for carrying the qualified individual exposure imvestigation[a levels include a detailed set of radiation as presented in Regulatory pro?*am and who i listed as the out'the institution's radiation safety
10.8, Appendix 0. Guide Radiation institution's"A plication for Materials Safety Officer on the N, RC--13M (see Exhibit A of Regulatory License-Medica*," Form Guide 10.8).
8.18-2
d. Conduct radiometric measurement of smear tests warrant an overriding priority and that cannot await from contamination surveys and source leak tests. alleviation of the radiation safety problems.
e. Store radioactive wastes and sources not in use. 2.6 Radiation Safety Committee f. Decontaminate personnel, clothing, and equipment. Part 35 requires that a radiation safety committee be appointed to supervise the institution's radiation safety g. Process orders for licensed radioactive materials and program. Typical functions and responsibilities of the receive and distribute such materials. committee are given in Regulatory Guide 10.8. The RSO,
who is required to be a member of the committee, may h. Receive, process, and file regulations and licensing either serve as chairman or assist the chairman in preparing correspondence. for and conducting meetings and maintaining committee records.
i. Prepare reports and records of surveys and personnel monitoring as required by 10 CFR Part 20. Meetings of the committee should be held at least quarterly. Every member of the committee should be j. Instruct and brief personnel as required by 10 CFR invited to each meeting.
Part 19.
The purposes of the meetings should include:
In addition, the tasks listed in the appendix should be examined for other activities that may require specific a. Discussing any radiation safety problems requiring a space allocations for Radiation Safety Offices in larger general solution;
hospitals.
b. Determining whether current procedures are maintain
2.4 Tasks and Procedures ing exposures ALARA;
The RSO and tne radiation safety staff are responsible c. Considering new proposals for the use of radioisotopes for conducting surveillance programs and investigations to and evaluating the safety of those uses and the qualifica ensure that occupational exposures are ALARA. In addi tions of the users; and tion, they should be vigilant in searching out new and better ways to reduce doses for jobs involving radiation d. Auditing the radiation safety program to ensure that exposure. A list of the types of tasks carried out by a it meets all the goals presented in Sections C.2.1 through Radiation Safety Office in order to provide good radiation C.2.5 and all pertinent regulations.
safety surveillance and meet regulatory and license condi tions is presented in the appendix. All radiation safety committee meetings should be documented by a record of minutes approved by committee For medical institutions in which a full- or part-time members and filed as part of the radiation safety record professional health physics staff is available, the planning of system within 60 days following each meeting.
radiation safety procedures by this staff should be carried out in coordination with management to ensure optimum 3. FACILITY AND EQUIPMENT DESIGN
efficiency and exposures that are ALARA. This coordina tion should extend to the implementation of the ongoing 3.1 General Considerations radiation safety program by the professional health physicists under the general supervision of the RSO. The design of facilities and equipment required for the medical uses of radioactive materials depends not only on
2.5 Administrative Authority hospital and medical care considerations, but also on the nature and quantity of radioactive materials involved and The Radiation Safety Office, supervised by the RSO, the relative potential for external and internal radiation should have responsibility for carrying out the radiation exposure. Major aspects of planning and design that should safety program, including the tasks listed in the appendix. be considered are discussed below.
This responsibility should be formally delegated in writing by responsible management and should include authority 3.1.1 Space Layout for the RSO to communicate directly with the level of management that can take corrective action when needed Facility layout should be planned to maintain employee to enforce rules and procedures pertaining to the institution's exposures ALARA while at the same time ensuring that radiation safety program. Administrative authority to exposure is not thereby increased to other persons in suspend certain activities temporarily should also be provided restricted or unrestricted areas. Considerations should to the RSO when needed in emergencies to avoid immediate include:
danger to life or health. However, the authority of the RSO
to suspend activities should be exercised only when it will a. The need for access to radiation or radioactive not interfere with life-saving medical procedures that materials areas by medical staff, employees, patients,
8.18-3
..sitors. and others, while at the same time providing d. Where appropriate, include specific types of filters or or'0tmum separation between workers' "sit down" areas of air cleaners for the exhaust air.
frequent occupancy and radiation sources or contamination, I
c. Rooms, in ihilch r.diOJti'tC oil)
r acroi.ol, InjdI hIk.
b. Ventilation requirements, including whether there is ilelcas-d .hoiuld c Iihnalnid l d Lit ncgatl,.,c I ' res.suire v1lI
a need to maintain lower pressures in rooms in which radio respect Io .djace.%nt ieownni h) ippripri.ILC exhaust V*'iitLIl active materials may possibly be spilled or volatilized;
I11 11 a i Ii a.
c. Floor loading for heavily shielded sources:
3.1.5 Fire Control d. Receipt and shipment of radioactive materials, The need for personnel exit and for closing the facility including radiation surveys of the shipping containers; to prevent the spread of radioactive materials should be considered for areas where laboratory procedures could e. Ingress and egress of some radiation therapy and result in dispersal of radioactive materials in the event of a nuclear medicine outpatients, including parking; and fire. Provision should be made for local showers and fire extinguishers, where necessary. For tie vast niajority of f. The need to protect supplies of stored diagnostic medical institutions, emergency procedures and training films from radiation exposure.
should include immediate fire control as a pnonty item.
3.1.2 Shielding
3.1.6 Special Laboratory Design Features Permanent shielding may be needed in some cases for walls, floors, and ceilings to provide protection against Consideration should he given to providing laboratory surfaces that may be easily cleaned and decontaminated radiation from radioactive materials currently housed in the daily to maintain mininial contamination levels and radiation institution, as well as radioactive materials that might be exposures, as well as minimal interference witn medical introduced into the area by future medical care require and clinical procedures. Laboratory needs may also include:
ments. Section 3.2 contains a discussion of permanent shielding for radiation therapy facilities. Teletherapy a. Provision for appropriate placement of radiation- and installations always require permanent shielding. Occupancy contamination-monitoring instruments;
and use factors should be taken into account as recom mended in NCRP handbooks, but such factors should be b. Designated sinks for rinsing and disposing of minor chosen with the principle of ALARA in min
d. The NRC
quantities of radioactive wastes (within 10 CFR Part 20
licensing staff should also be consulted during the planning limits);
and design stage to obtain licensing guidance on acceptable use and occupancy factors in shielding design.
c. Special plumbing and waste storage provisions: and
3.1.3 Caution Signs and Interlocks d. Adequate separation between areas occupied by personnel and radiation sources or contamination.
Access to certain areas should be controlled or restricted by the use of caution signs, signals, and interlocks as In general, there is no need in hospitals for any proce required by § 20.203 of 10 CFR Part 20.
dures that would use quantities of radioactive material sufficiently radiotoxic that potential air concentrations
3.1.4 Ventilation may reach levels approaching the concentration values given in 10 CFR Part 20. Ventilation and contamination control To the extent possible, the licensee should: should be designed to maintain air concentrations and contamination levels as low as reasonably achievable.
a. Provide any necessary local exhaust ventilation (such Guidance for the use of Xe-133 in nuclear medicine is as chemical hoods) or general ventilation as recommended available from the Office of Nuclear Material Safety and by professional health physicists for areas where breathable Safeguards, U.S. Nuclear Regulatory Commission, or concentrations of radioactive material may be present. in Regulatory Guide 10.8.
b. Design exhaust systems to avoid transporting contami nated air through long ductwork passing through many
3.1.7 Storage. Source Control, and Inventory other hospital areas on its way to the stack on the roof.
In institutions ordering a numhcr and variety of sources c. Locate exhaust vents so as to provide meteorological of radioactive material, it is often easier, less costly, and diffusion and dilution adequate to meet § 20.106 of more secure to provide a centralized storage room for
10 CFR Part 20 requirements for effluents to unrestricted radioactive materials not in use or used only occasionally.
areas and ALARA exposure considerations for the public.
Such a facility is also helpful in keeping exposures ALARA,
as well as to avoid recirculating contaminated exhaust air since it may result in a decrease in the amount of radioactive into the building. material stored in lahuiratories micciipied by personnel.
8 18-4
3. 1.8 Shipping and Receiving 3.2 Radiation Therapy Equipment and Facilities Specific NRC licensing guides are provided for licensed Medical institutions should:
radiation therapy programs, and the NRC licensing staff reviews the safety aspects of facilities and equipment before a. Plan specific radioactive material storage areas for issuing a license. In designing shielding for teletherapy day, night, and weekend deliveries so that deliveries of radioactive materials may be received at any time and treatment rooms, the medical institution should consult placed in a secure locked location where they will not cause NCRP Handbook 34 or 49 (Ref. 9) for recommended design details; specifications; methods of shielding against unnecessary exposure to personnel while awaiting survey by direct, scattered, and leakage radiation; and general the Radiation Safety Office or the user. A written procedure for receipt, survey, and storage of deliveries should be principles of radiation safety design.
provided to anyone responsible for the receipt or delivery of radioactive material. In addition, the institution should:
a. Protect each teletherapy treatment room from b. When packages may expose couriers to measurable radiation, make available a cart or carrier that will maintain inadvertent entry by the following means:
an adequate distance between the person transporting the material and the package to keep exposures ALARA.
(I) Provide a door interlock that allows a "Beam On" condition only when the door is closed, and turns c. Provide space in the receiving area for an initial survey the beam off if the door is opened.
and smear test of each package unless other means are used to avoid transporting a contaminated package through (2) Provide independent backup caution lights on the unrestricted areas of the hospital. console, above the door, and inside the treatment room to indicate the "Beam On" condition to radiotherapy technol d. Locate shipping and receiving areas and the access to ogists and other staff members. Independent audible them away from areas where radioactive materials are used signals also provide added safety in the event the caution so as to (1) minimize the time required for transporting lights fail.
radioactive material to areas where it is to be used and (2)
avoid the need to transport radioactive materials through (3) Establish a procedure for checking whether crowded areas or areas occupied by personnel, patients, or everyone except the patient is out of the treatment room visitors. before the door is closed and the beam is turned on.
(4) Install independent gamma ray sensing caution
3.1.9 Equipment Considerations lights or signals near the entry inside teletherapy treatment rooms to provide a warning to the therapy technologist or General features applicable for equipment that will be others entering the room in case the door interlock system used for handling or containing radioactive materials are as fails when the beam is in the "on" condition.
follows:
(5) Provide a "scram" button for emergency shut a. Surfaces should be easy to clean and decontaminate down of the source from inside the teletherapy room and in case unsealed radioactive material is released. provide audio communication with the outside control panel.
b. Equipment should be designed to optimize the ease of carrying out procedures where personnel are exposed to radiation, thereby minimizing working times, and to b. Consider leakage through the teletherapy head with maximize distances of personnel from the radioactive the source in the "on" position when designing shielding.
materials with which they are working to an extent con Data provided by the manufacturer of the teletherapy sistent with the purposes of the procedure. machine and NCRP recommendations should be used for this purpose.
c. Equipment should operate in such a fashion that it does not damage radiation sources and release radioactive c. Design areas adjacent to the treatment room that will materials if it failg. be occupied by personnel, patients, or visitors who are not associated with the radiation therapy department so as to d. Adequate shielding should be provided as part of the maintain exposures ALARA. Reduction of occupational equipment, where feasible, to keep exposures ALARA. exposures to radiation therapy personnel should be achieved by design provisions, procedpres, or beam orientations that e. Appropriate caution signs, symbols, signals, and are directed toward unoccupied or low-occupancy areas. In alarms should be provided as part of the equipment to meet no case should it be necessary to design for instantaneous the requirements of § 20.203 of 10 CFR Part 20 and rates greater than 10 mrad/week in restricted or unrestricted recommended standards of the medical physics profession. areas adjacent to teletherapy treatment rooms.
8.18-5
3.3 Nuclear Medicine Facilities
3.4 In Vitro Clinical and Research Laboratories To ensure that exposures are ALA RA, layout and design Many of tile design considerations for in vitro clinical for new nuclear medicine facilities and equipment should: and research laboratories are similar to those already given a. Allow sufficient space for personnel operating for other facilities. Special considerations include:
nuclear medicine equipment to be at least one meter and preferably two meters from any patient undergoing imaging a. Easily discarded bench paper. absorbent on the top wnenever surface only, for catching and easily disposing of small the condition of the patient and other conditions permit, or -amounts of contamination that may drip or be removed provide adequatc portable shields.
from laboratory apparatus and glassware.
b. Allow adequate space for stretcher patients awaiting b. Suitable easily cleaned drip trays for carrying scans as well as for outpatients. Dosed patients out awaiting manipulations of radioactive materials where spillage scans may cause radiation levels on the order of may
10 inR/h or occur.
more near the edge of tae stretcher. They may need to be segregated from the general waiting area to reduce radiation c. Protective clothing, including rubber or plastic dis exposure to receptionists and persons passing.throughi the posable gloves, for persons working with radioactive area, such as orderlies and aides. mate rials. (Disposable gloves should be changed frequently.)
c. Locate physicians' offices and other occupied Equipment should be provided for monitoring areas clothing within easy access to needed radiopharmaceuticals, before laundering. Radioactive laundry and radioactive but wastes should be turned over to the Radiation Safety Office allow enough distance (several meters is usually sufficient) for further disposition when surveys indicate contamination to minimize exposures from stored radiopharmaceuticals 2 levels may exceed 10-5 uCi/cm and radioactive wastes.
d. Provide adequate shielding for stored radiophar Additional information on carrying out in vivo experi maceuticals and adequate body shielding for ments with animals is given in Reference II and employees NUREG-0267.
preparing dosage for patients.
e. Supply an adequate number of syringe shields 4. SAFE WORK PRACTICES AND PROCEDURES
and vial shields (as well as appropriate tongs or forceps)
near 4.1 General Principles the place of dosage preparation.
f. Provide adequate exhaust ventilation (Ref. 10) The safe work practices and procedures contained in this in the section for handling radioactive materials in medical institu laboratory near or in the radiopharmaceutical storage and dose preparation areas to protect against airborne tions are recommended as a minimum. Additional informa radioactive tion is contained in NUREG-0267, Regulatory Guide 8.23, or toxic materials that might result from accidental release and Regulatory Guide 10.8.
or spill of radiopharrnaceuticals.
g. Include a special shielded waste receptacle for used 4.1.1 Periodic Inventory and Control of All Radiation syringes and other radioactive wastes in the nuclear medicine Sources laboratory near the dosage preparation area.
h. Locate a permanently fixed radiation counter Many of the more serious occupational exposures, as or rate well as patient exposures, have resulted from misplaced or meter near the entrance to the nuclear medicine preparation lost radioactive material, which then may inadvertently laboratory for employees to check regularly for hand or expose unsuspecting persons or may be subject to improper clothing contamination when leaving the department.
A usage by unauthorized persons. The following procedures portable survey meter available at a convenient location will should be taken to guard against these problems:
also help keep exposures ALARA.
i. Provide individual labeled lockers and change a. Periodic inventories should be made of all radioactive areas for sources, and a continuous record of the locations of segregating laboratory coats that may be contaminated all from other clothing when operations are such sources and their usage should be maintained. The inventory that con should be combined with an inspection to ensure proper tamination levels on persons or clothing may exceed action labeling (see § 20.203 of 10 CFR Part 20). Paragraph 35.14 levels of Regulatory Guide 8.23, "Radiation Safety Surveys (bXSXv) of 10 CFR Part 35 requires inventories of sealed at Medical Institutions."
sources in Group VI and calibration sources to be conducted j. Provide finger badges or dosimeters as well as body at least quarterly. Inventory procedures should also provide dosi:neterm for monitoring occupational exposure for the RSO to he alerted if all sources are not returned of per within a specified time in order to avoid sending patients sonnel involved in dose preparation and injection and home with brachytherapy sources still in place (see handlin,, of patients. Refer ence 12).
8.18-6
b. Sources should be secured within locked rooms or touched or held with the fingers, but only with tongs or storage areas when authorized users or their responsible tweezers appropriate to the operation.
employees are not present (see Section C.3.1.7 of this guide). Special shielded vaults or containers should be b. Finger dosimeters4 as well as body dosimeters should provided in the storage area for sealed sources. be worn by personnel who are handling or manipulating unsealed or unshielded sources with tongs or forceps or c. Authorized persons should be required to sign for the who are holding partially shielded containers of radioactive removal and return of each source. The source log should material with their hands. However, these dosimeters are be checked regularly by the Radiation Safety Office staff. not needed for personnel handling only the types of sources used for tracer level in vitro studies or if dose rates are less
4.1.2 Shielding than 5 mrem per hour at 1 cm.
All radioactive material not in use should be *Welded so c. Special attention should be given to instructing all that exposure rates in any area that may be occupied by nursing staff and others coming in contact with patients personnel will be well below (ALARA) the levels for who may be excreting radioactive material that they also unrestricted areas given in 10 CFR Part 20. Whenever may need to follow precautions to avoid contaminating radioactive materials are in use, the material should be themselves and others.
unshielded only in the direction necessary for its use and to the extent that accessibility to the source is necessary. d. When working with unencapsulated radioactive materials, personnel should wear rubber or plastic gloves
4.1.3 Control of Contamination and other special clothing.
Radioactive materials in unsealed form or undergoing e. Care should be taken to avoid needless contamination chemical or physical processing should be handled only in of objects such as light switches, taps, or door knobs.
properly designed facilities (as described in Section C.3.3 above) and with proper procedures to avoid transferring f. Radioactive solutions should never be pipetted by radioactive material to the air or to surfaces if inhalation or mouth.
ingestion of the material by personnel is possible. Heat sterilization should be avoided if it might cause rupture of g. Eating, smoking, drinking, and application of cos the source. If necessary to ensure that exposures are ALARA, metics should be prohibited in laboratories where radioactive preliminary tests of procedures should be carried out materials are handled.
with nonradioactive simulated materials or colored liquids to check provisions for containment, handling, and ventila h. Special precautions should be taken to avoid the tion. The Radiation Safety Office staff may make prelimi possibility of small amounts of radioactive material entering nary estimates of job exposure commitments using tracer into cuts.
levels of radioactive material.
i. The use of containers or glassware with sharp edges Trays and absorbent materials should be used as a should be avoided. Care should be taken to avoid bites or backup to catch and limit the spread of radioactive con scratches in working with animals to which radioactive tamination whenever there is a possibility that planned materials have been administered.
procedures will fail to contain the radioactive material.
j. Food and drink should not be stored in the same Protective clothing appropriate to the type and quantity place (e.g., refrigerator) with radioactive materials.
of radioactive material being processed should be worn whenever escape of radioactive contamination is considered k. Radioactive materials should be secured (e.g., placed possible. in a locked room) when personnel are not present.
4.1.4 Proper Work Habits I. Surveillance of individual operations such as "milking"
generators should be provided to ensure that workloads are In general, all personnel handling radioactive materials distributed so that individual employee doses are kept should be trained to use appropriate shielding materials, ALARA.
maintain as much distance as possible from radiation sources, and limit the time of exposure to radiation sources 4.1.5 Radiation or Radioactivity Monitoring to the time necessary to carry out the required task or clinical procedure. The independent radiation surveys, inspections, inven tories, and smear tests to be carried out by the Radiation The following good work habits are particularly important Safety Office staff were discussed in Section C.2. In addition, in ensunng that exposures are maintained ALARA:
" Wire some finger dosimeters, labels may wash off or the bad e
4 my ripg protective loves, In these case, wrist baes may"b a. Except for very-low-level sources such as flood preferable. In any cae, the User shoud be aw of the fact that deither of these donmeten will measwe wry high finger comtact sources or other sources designed for manual use in checking do-es, and handling unshielded syringes or bottles with the finges instrumentation, sealed or unsealed sources should not be should be absolutely avoided.
8.18-7
each user of radioactive materials should survey radiation
4.2.1 Teletherapy and radioactivity levels within his or her own operations daily to help maintain exposures ALARA. A simple logbook Radiation protection measures in teletherapy should rely of readings or general levels of radiation or contamination primarily on the adequacy of facilities and equipment since may be helpful if maintained by the user to indicate any very intense radiation levels arc generated (see Sec changes in radiation or radioactivity levels that show a need tion C.3.2). Nevertheless, some basic routine operating for changes in procedures or equipment to meet ALARA
principles for maintaining occupational exposures ALARA
radiation exposure objectives. Regulatory Guide 8.23 and should be followed:
Regulatory Guide 10.8 give further guidance on radiation surveys in medical institutions (and nuclear pharmacies).
- a. With the aid of the maintenance and operating manuals provided by the manufacturer of the teletherapy In hospital situations in which the higher exposure rates unit, procedures should be established for routine main may occur (e.g., in teletherapy rooms where, in an accident, tenance and checkout of safety-related features of the the limits of 10 CFR Part 20 could be approached before teletherapy unit.
an indication is provided by routine personnel-monitoring devices), "self-reading" devices that may be read by the b. A daily morning checkout procedure should be wearer at least daily, as well as warning devices worn on the established and posted for the therapy technologist to carry body, may be helpful in maintaining exposures ALARA.
out simple operational checks of indicator lights, caution lights and signs, key and door interlocks, gamma radiation
4.1.6 Training level indicators, timer operation, and interlock function.
Employees should be made aware of the ALARA provi c. A general safety check, including a spot or point sions of § 20.1 of lO CFR Part 20 and the guidance of radiation output check and check on beam alignment and Regulatory Guide 8.10. Employees should be instructed in confining devices, should be made and recorded at least the philosophy and recommendations of Regulatory monthly. All records of the monthly output and safety Guide 8.13, "Instruction Concerning Prenatal Radiation check, as well as the morning checkouts, should be signed Exposure," whenever there is a possibility that pregnant and dated by the persons carrying out the tests.
women may be exposed to radiation.
d. During patient treatment or operation of the tele Each employee should be acquainted with the institution's thempy unit for calibration or maintenance procedures, own procedures for handling radioactive sources and care should be taken to follow written instructions and use radioactive materials and with NRC licenses and their installed safety devices to ensure that no personnel except radiation safety provisions (including license conditions the patient to be exposed are in the teletherapy treatment incorporated from license applications and correspondence).
room during the "Beam On" condition. These procedures Copies of these procedures, licenses, and related correspon are also important when personnel carry out test procedures dence should be made available for review by employees as with phantoms on the treatment table.
part of their orientation to radiation safety requirements.
Professional education and development to ensure that staff e. During "Beam On" operation, the operator at the members are up to date on radiation safety methods should console should remain in a position of lowest radiation also be supported. intensity consistent with vigilance of the console and patient during treatment, as advised by the Radiation Regulatory Guide 10.8 should be consulted for a list of Safety Office staff using the postinstallation radiation topics important in training radiation workers.
survey. In a well-designed facility, the shielding provides a very high degree of protection at the location of the console.
4.2 Radiation Therapy However, all persons not required to remain near the console should remain or work in areas of lower radiation
"This guide provides recommendations for maintaining intensity while the teletherapy unit is in operation. During exposures ALARA in three subdivisions of radiation
"Beam Off" conditions, treatment setup should be accom therapy: plished with minimum occupancy of the room and minimum time spent near the source to keep exposures from leakage a. Teletherapy-the treatment of patients with high radiation ALARA.
energy beams from shielded irradiators containing sources of high gamma ray emission rates. f. Emergency procedures established as required by NRC regulations or license conditions should be tested by b. Brachytherapy-the treatment of patients by insertion regular familiarization sessions or by staging mock emer of sealed sources such as needles or tubes for interstitial or gencies for the training of personnel.
intracavitary irradiation or by surface application.
4.2.2 Brach ytherapy c. Radiopharmaceutical therapy-the injection or oral administration of solutions or colloids of radioactive Detailed recommendations for reducing radiation pharmaceuticals that tend to concentrate in and irradiate exposures in brachytherapy are given in NCRP Report the organs in which they are dispersed or absorbed. Number40 (Ref. 12), and additional recommendations
8.18-8
pertinent to brachytherapy, as well as radiopharmaceutical operating room or by afterloading in the patient's room.
therapy, are contained in NCRP Report Number 37 (Ref. 13). These time/exposure studies should be recorded and Some of the most important practices for maintaining reported to the personnel involved to maintain an awareness exposures ALARA are: of radiation exposures resulting from these procedures.
a. Modem afterloading devices should be used wherever k. Transport of a patient containing radioactive material medically acceptable. Remote afterioaders are particularly to areas outside the operating room and to his room should effective in keeping exposures ALARA. be directly supervised by the Radiation Safety Office staff or the radiation therapy staff. Also, transport of afterloading b. Jigs or remote afterloaders should be prepared and sources and supplies for insertion of applicators, lead tested for ease in loading sources into afterloading devices bedside shields for the nurses, and any other supplies and lin the patient's room. equipment required for expediting an efficient afterloading procedure should be checked and supervised by the Radia c. When manual afterloading is used, jigs for loading the tion Safety Office staff or the radiation therapy staff.
afterloaders should be set up behind shields with lead glass Radiation surveys should also be carried out on a sample viewing windows, and auxiliary lead brick shielding should basis and recorded to maintain an awareness of the exposures be provided to shield the arms of the personnel loading the resulting from these procedures.
afterloaders for as much of the duration of the procedure as possible. 1. Nursing personnel should be provided with personnel dosimeters (when required by 10 CFR Part 20) and should d. When the radiation sources of afterdoading sleeves or be trained in their use.
ovoids are loaded, they should be placed in adequately shielded carts or transport devices for liquid sterilization or m. Patients should be surveyed by the radiation safety transport to the patient's room when the physician is ready staff after removal of brachytherapy sources and before to insert the afterloaders. These carts should be properly discharge a a final step to check against incomplete removal tagged and should at all times be under the supervision of of these sources from the patient, leakage of contamination the radiation physicist, the radiation safety staff, or a from sources, or inadvertent loss of sources. Also, all linens member of the radiotherapy staff.
and waste should remain in the room until checked-by a survey meter or until all sources are accounted for.
e. Simiiw p"Ktetion should be provided for use in threading radioactive needles for implant therapy.
4.2.3 Radiopharmaceutical Therapy (Nuclear Medicine.
f. While manipulating sources, loading the afterloaders, Therapy with Unsealed Radioactive Materials)
and threading needles, personnel should be provided with tongs and surgical clamps to maintain the distance of the Where feasible and in the best interests of the patient, administration of millicurie quantities of the types of fingers about 30 centimeters or more from these sources.
radioactive drugs used for therapy of specific diseases should be carried out in a specific area or room separate g. Finger dosimeters as well as body dosimeters should from other nuclear medicine or radiotherapy operations.
be worn by personnel when they are loading or preparing sources for insertion. Also, the Radiation Safety Office However, this special area or room should be in the general staff should periodically survey the loading procedures and vicinity of the laboratory where the radiopharmaceuticals are stored to eliminate the need for transporting these provide job-time/exposure information to help employees materials over long distances or through other areas of the maintain exposures ALARA. Use of a gamma alarm monitor in the storage or loading area will indicate when radiation institution. When these materials must be transported to a sources are outside their shields and help avoid inadvertent patient's room for administration, good radiation safety practice and efficient medical procedure often dictate exposure due to lost or misplaced sources.
that the radiation safety staff should monitor and assist in the preparation of the materials and supplies, the transport h. A continuing list and count of removals and returns of the materials to the patient's room, and the administration of individual sources from the storage containers should be of the radioactive drugs as directed by the physician in maintained to help ensure against inadvertent loss of charge. Precalibrated contained sources (e.g., capsules)
sources and exposure of personnel. should be Ised whenever possible. When therapy is carried out with potentially volatile radioodine compounds, i. Sources maintained in fixed position for a constancy Regulatory Guide 8.20, "Applications of Bioassay for l-125 check on the operation of any intracavitary ion chambers and 1-131," should be consulted to determine whether should be maintained within shielded wells in constant geometry so they can be used for a rapid and safe check of employees who have participated in the radioiodine adminn istration should be sampled for bioassay.
ion chamber operation before the treatment of each patient.
After treatment, all articles should be surveyed j. Job-time/exposure studies should be carried out by for possible contamination before they are released from the the radiation protection staff on typical surgical implants and typical insertions of radioactive sources-either in the room. Contaminated articles must be released to the Radiation Safety Officer for decay or disposal. Also, the
8.18-9
patient should be surveyed before release and should be those areas in the laboratory most frequently occupied by instructed on ways to minimize contamination of the personnel consistent with ease of disposal.
environment and exposure of other mnembers of the public.
g. Use protective lead screens to protect employees and In supervising the adm inistr.tion of radiopharmacebtzcals other patients dunng procedures using Tc-99mn or other to patients, the physician in charge and the radiation safety low-energy gamma emitters (for example, when there is a staff may use many of the principles given for brachytherapy room full of patients awaiting brain scans) it the screens do in Section C.4.2.2 above, as well as principles and practices not interfere with the diagnostic tests. Portable screens of presented in NCRP Report 37 (Ref. 13). The use of these Ph onJy 2 mm thick will reduce Tc-99m gamma-ray expo procedures should help ensure that exposures to hospital sure rates to less than 0.5 percent of those without the staff and private duty nurses are ALARA not only during screens.
the administration of the dosage to the patient, but also during any hospital care of the patient, during and after h. In lung perfusion or ventilation studies with discharge of the patient, and in the event of any later xenon-133, use additional lead shielding 1.6 mm thick (or surgery, autopsy, or burial of the patient. Additional appropriate thicknesses for other radioactive gases or guidance is available from the Material Licensing Branch, aerosols) around the absorber canister, oxygen bag, and Office of Nuclear Mlaerial Safcty and Sdfcuards. Nitriciv waste receptacle to reduce occupational exposures when Regulatory Commission. and in Appendix K io Regnilator.
frequent procedures are carried out. Also use proper Guide 10.8. equipment to prevent leakage or contamination from the radioactive material being used. Installation of a 133 Xe monitor in the room where ventilation studies are performed
4.3 Diagnostic Nuclear Medicine will warn of any leakage of 13aXe.
Many of the principles of radiation protection practice i. In addition to regular nursing staff who receive in diagnostic nuclear medicine were discussed in previous personnel monitoring, private duty nurses and others who sections on recommendations for nuclear medicine facilities may come into close contact with patients who have been and equipment (Section C.3.3) and general principles of administered radiopharmaceuticals for diagnostic or thera safe work practices in handling radioactive materials (Sec peutic purposes should be carefully monitored for exposure tion C.4.1). Additional recommendations are: and contamination and should receive appropriate instruc tions and briefings on radiation protection procedures.
a. Use syringe shields for administering all injections of radioactive material; only compromise this procedure on 4.4 Low-Level Clinical or Medical Research Laboratory rare occasions when absolutely necessary. Also, use gloves Activities to protect against possible large doses from hand contamina tion. Laboratories in medical institutions that use tracer amounts of the less radiotoxic nuclides may keep exposures b. Place radionuclide generators as far as possible from ALARA by using the recommendations given in Sec areas occupied by workers in other nuclear medicine tion C.4.1. Many of the radionuclides used for in vitro operations, with adequate ventilation and additional clinical tests such as radioimmunoassay and other low-level shielding as necessary to reduce external as well as internal in vitro or animal studies involve pure beta emitters or weak exposure to personnel during elution. gamma emitters with only microcurie or submicrocurie quantities handled and processed by individual personnel at c. Use samples in shielied bottles for checking the assay any one time. External and internal radiation exposures to of eluates in the nuclear medicine dose calibrator or other personnel in such laboratories should ordinarily be main suitable assay system. Calibration procedures with a smaller tained well below 10 percent of the permissible occupa quantity of radioactive material may sometimes reduce tional exposure limits of 10 CFR Part 20 through careful exposures ALARA. (See Regulatory Guide 10.8 for proce initial planning of laboratory facilities, equipment, and dures.) procedures by the laboratory supervisor in conjunction with qualified health physics personnel.
d. Shield chamber calibrators, where possible, to main tain employee exposures ALARA while nuclear medicine 5. MANAGEMENT AUDIT AND INSPECTION OF THE
doses are being calibrated. Recalibrate refitted chambers as RADIATION SAFETY PROGRAM
necessary.
Ultimate responsibility for the establishment and con e. Use fume hoods (Ref. 10) and good contamination tinuation of an adequate radiation safety program in a control principles when preparing dosages of radiophar medical institution has been placed with the governing maccuticals that have potential volatility or a potential for body of the hospital. The administrator reporting to this release from rubber septum syringes. governing body should be sufficiently informed at all times to be sure that all regulations arc faithfully adhered to and f. Keep shielded radioactive waste cans for used syringes that the use and safe handling of radioisotopes are properly and other radioactive wastes at the greatest distance from carried out to maintain exposures ALARA.
8.18-10
The hospital administration shiould carry out an annual
D. IMPLEMENTATION
audit of the radiation safety program in cooperation with members of the radiation safety committee and the Radia tion Safety Office. The results of this audit may then be The purpose of this section is to provide information to discuned at an .nnual radiation safety committee meeting applicants and licensees regarding the NRC staff's plans for to ensure that all users and responsible staff are aware of using this regulatory guide. This guide reflects practices current policies and procedures and methods for their currently acceptable to the NRC staff. Except in those improvement. NUREG-0267 contains an example of a - cases in which the applicant or licensee proposes alternative checklist of items that may be inspected by the administra practices or methods for complying with specified portions tion during this annual audit. A report containing the of the Commission's regulations, the practices or methods results of the audit should be maintained by the Radiation described herein together with those in other applicable Safety Office fnr possible use in expediting azy inspections regulatory guides are being and win continue to be used as a by regulatory or accrcditing agencies, as well as for reference basis for the=evaluation of applications for specific materials in further auditing and improving the ALARA program. licenses for medical institutions.
8.18-11
APPE;4DIX
RADIATION SAFETY TASKS IIJVOLVED hI
KEEPING OCCUPATIONAL EXPOSURES ALARA
1. Surveys of the following radioactivity areas: 6. Lecal-tesuing radioactivw sources using toe tollowing techniques:
a. Nuclear medicine b. Radiation tnerapy a. Wiping c. Oncology b. Counting d. Pathology c. Calculations e. Cardiology d. Recording f. Pediatrics L% Counter calibration g. Radioactive waste disposal and storage h. Other research and clinical laboratories using radio 7. Evaluation of internal exposure by Means of:
active materials a. Collection of sa*iiples, including air sampkls where'
2. Surveys of diagnostic and tilerapet-tic machines and applicable generators, including: i. Radiochernical or scintillalion bioassay analysis c. Counter calibration a. Teletherapy sources and machines d. In vivo counting h. Computerized axial tomography scanners e. Computer analysis of results c. Interlock and safety checks d. Calibrations 8. Special surveys of patients and rooms for implant.
e. Fluoroscopes intracavitary. or unsealed radiopharmaceutical therapy, f. Radiographic x-ray including:
3. Personnel monitoring: a. Roioh preparation and protective covering b. Labeling (bed. chart, door)
a. Review of personnel exposure data and reports c. Nursing staff and housekeeping staff briefings b. Preparation of reports required by regulations d. Background surveys c. Filing, collection, and ,ailing of personnel monitoring c. Source insertion and afterloading surveys devices (including late and lost) f. Surveys of patients in operatinp roo,n and recovery d. Special investigations of exposure and notifications to room regulatory agencies where appropriate g. Placing of lead barriers e. Calibration of personnel monitoring dosimeters, h. Recovery of sources and wastes including commercially supplied filn badge service i. Survey of room cleanup and decontamination j. Instructions to patient and to family of patient, as
4. Radiation safety instrument calibration and maintenance: appropriate k. deasurement of radiation from cadavers, briefings to a. Calibration pathology staff and funeral directors. where Ih. Hattery replacement and adjustmenl appropriate C. Pockel clhamber ind ILl) calibration d. Minor repair telectronice
9. Administration and consultation. including:
C' lusntruumen islectiton adlh disiribtiion f. (heck-sou rce calibraliOrn a. App~roval of facilities. equipment, and procedures used in areas where radioactive materials are handled
5. Decontamination and waste disposal: h. Preparation of license applications and amendments c. Preparation of hazard evaluation reports for licensing, a. Collection and packaging d. Programming of routine required surveys b. Surveying e. Supervision of routine radiation safety operations c. Recording f. Revisions to radiation safety manual d. Shipping arrangements g. Periodic radiation safety instruction for hospital staff e. Placarding and administration I. Decontamination at surgical instruments. rooms, and h. Training of residents and iiedical staff laboratories i. Conlerences with physicians and other safety staff
8. 18-12
q. Planning prompt effective response to incidents and j. Coordination of Radiation Safety Committee meetings emergencies involving radiation and minutes r. Providing instruction or direction for outside persons k. Inspections and discussions with government regula tory agency representatives (for example, firemen) who would respond to an I. Professional meetings emergency situation involving or potentially involving radiation m. Selection and ordering of equipment and supplies n. Planning and budgeting s. Preparation of Radiation Safety Office reports to hospital administration.
o. Facility and shield design and meetings with architectsW
p. Record maintenance and reiated computer programming
8.18-13
REFERENCES
U.S. Nuclear Regulatory Commission, "Principles and 8. Department of Health, Education and Welfare, Practices for Keeping Occupational Radiation Expo
"Health Physics in the Healing Arts," Publication sures at Medical Institutions As Low As Reasonably No. (FDA) 73-8029, Proceedings of the Seventh Achievable," NUREG,0267, 1982.
Midyear Symposium of the Health Physics Society, San Juan, Puerto Rico, December 1972.
2. National Bureau of Standards. "Permissible Dose from External Sources of Ionizing Radiation," Handbook 59,
9. National Council on Radiation Protection and Measure Recommendations of the National Council on Radia ments, "Medical X-Ray and Gamma-Ray Protection tion Protection (NCRP Report No. 17), Washington, for Energies up to 10 MeV-Structural Shielding D.C., September 24, 1954.
Design and Evaluation," NCRP Report No. 34, Washington, D.C., 1970, Reissued as NCRP Report
3. National Council on Radiation Protection and Measure No. 49, "Structural Shielding Design and Evaluation ments. "'Review of the Current State of Radiation for Medical Use of X-Rays and Gamma Rays of Pr+/-aetion Philosophy'" Report No. 43. Washington.
Energies up to 10 MeV," September 1976.
D.C.. January 15. 1975.
10. Committee on Industrial Ventilation, "'Industrial
4. National Academy ot Sciences-National Research Ventilation," American Conference of Governmental Council. "The Effects on Populations ot Exposure lo Industrial Hygienists, Lansing, Michigan, 1975.
LA-i Levels of ionizing Radiation: 1980.*
Washington. D.C. II. National Council on Radiation Protection and Meas urements, "Radiation Protection for Medical and
5. Federal Radiation Council, "Background Material for Allied Health Personnel," Report No. 48, Washington, the Development of Radiation Protection Standards,"
D.C., 1976.
Report No. 1, Washington, D.C., 1960.
12. National Council on Radiation Protection and Meas
6. International Commission on Radiological Protection, urements, "Protection Against Radiation froim
"Implications of Commission Recommendations That Brachytherapy Sources," Report No. 40, Washington, Dosýes Be Kept As Low As Readily Achievable," Report D.C., 1972.
No. 22, Pergamon Press, Elmsford, New York, 1974.
13. National Council on Radiation Protection and Meas
7 C.B. Bracstrup and K.J. Vikierlof. -'Manual on Ratltd urements, "Precautions in the Management of t1on Protection in Hospitals and (;henral Pract:c.'"
Patients Who Have Received Therapeutic Amounts of Vol. 1. *"'Ba.i Protection Requirements." Worh, Radionuclides." Report No. 37, Washington, D.C..
Health Organization. Geneva. SwIIzerlnd. 1974.
1970. '
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