ML20197D668

Principles & Practices for Keeping Occupational Radiation Exposures at Medical Institutions Alara. Draft Companion to Reg Guide 8.18

ML20197D668
Person / Time
Issue date:	12/31/1977
From:	Brodsky A NRC OFFICE OF STANDARDS DEVELOPMENT
To:
References
NUREG-0267, NUREG-267, NUDOCS 7811280372
Download: ML20197D668 (53)

Text

NUREG-0267 [

PRINCIPLES AND PRACTICES FOR KEEPING OCCUPATIONAL RADIATION EXPOSURES AT MEDICAL INSTITUTIONS AS LOW AS REASONABLY ACHIEVABLE Draft p" "%

Office of Standards Development U. S. Nuclear Regulatory Commission 281128031E

N0TICE

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The author is a staff member of the Division of Siting, Health,and Safeguards Standards of the U. S. Nuclear Regulatory Conmission. The statements herein do not necessarily represent those of the Nuclear Regulatory Commission; the report has neither been approved nor disapproved by that Commission.

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PRINCIPLES AND PRACTICES FOR KEEPING OCCUPATIONAL RADIATION EXP,OSURES AT MEDICAL INSTITUTIONS AS LOW AS REASONABLY ACHIEVABLE l

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i Draft A. Brodsky l

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! Manuscript Completed: October 1977 Date Publisheri: December 1977 Office of Standardc Development U. S. Nuclear Regulatory Commission Washington, D. C. 20555

TABLE OF CONTENTS Chagter Page_

PREFACE... . . ......... ... .. ............... ... .... . .................. iii

- 1. INTRODUCTION..... .... ................ ..... ... ..... ....... . ..... ... . 1-1

2. BACKGROUND...... .. .. .............. . . ........ .... . ........... . . .... 2-1

3. METHODS FOR MAINTAINING ALARA EXPOSURES. . . . . . . . . . . . . . . . . . . . . . . . . . .. ..... 3-1 3.1 Ma nagemen t Philosophy a nd Organi za tion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1 ,

3,2 Radia tion Saf ety Of fice Func tions. . . . . . . . . . . . . . . . . . .......... .... . 3-l' 3.2.1 Sta f fi ng and Organi za tiona l Requi rements. . . . . . . .. . . . . . . . . .. ... 3-2 3.2.2 Radiation Safety Personnel Qualifications. . . .. .. ... .... .. ... 3-2 3.2.3 Space and Equipment Requirements .. ... . . . . . . .... . .. ........ .. 3-3 3.2.4 Ta s k s a nd P roc ed u res . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .......... 3-4 3.2.5 Administrative Authority. . ................. ..... ... . .. ....... 3-5 3.2.6 Ra d i a t i on Sa fety Conmi t tee. . . . . . . . . . . . . . . . . . . ..... . . . . ... . 3-5 3.3 Facility and Equipnent Design. .. ......... .... .. ...... . . .. ..... 3-5 .

i 3.3.1 General Considera tions. . . . . . . ................... ................ 3-5 3.3.1.1 Space Layout. ................ .. . . .... .......... .... . 3-5 3.3.1.2 Shielding..................... . . .... .......... . ..... 3- 6 3.3.1.3 Caution Signs and Interlocks....... ........................ 3-6

3. 3.1. 4 Ventilation... ........ ............. .. ......... .. .. .. 3-6

3. 3.1. 5 Fire Control..... ................. ............. . . ...... 3-7

3. 3.1. 6 Special Laboratory Design Requirements. . . . . . . . . . . .. .... . 3-7 3.3.1.7 Stcrage, Source Control, and Inventory. . .. . . . . . . . . .. 3-7 3.3.1.8 Shipping and Receiving............................ . . 3-8 3.3.1.9 Equ ipment Cons i dera tions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3- 3 3.3.2 Radiation Therapy Enuipment and Facili ties. . .. . . . . . . . . . . . . . . . . . . . 3-9 3.3.3 Nuc l ea r Med i c i ne Fa c il i ti es . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10 3.3.4 In-Vitro Clinical and Research Laboratories. ... .. . ....... ..... 3-11 3.4 Safe Work Practices and Procedures............. ........... .. ............ 3-13 3.4.1 General Principles................... .... ....... ... .......... ... 3-13

, 3.4.1.1 Periodic Inventory and Control of All Radiation Sources.. .. 3 3. 4 .1. 2 Shielding..................... ........... . . ... ... . .. 3-13 3.4.1.3 Control of Contamina tion. . . . . . . . . . . ....... ... ....... 3-14 3.4.1.4 Proper Work Ha bi ts. . . . . . . . . . . . . . . . . .... .... .. .... .... 3-14 3.4.1.5 Ra diation or Radioacti vi ty Moni toring. . . . . . . . . . . . . . . . . . . . 3-15 3.4.1.6 Training...... . . ..... .......... ... .. . .. ..... ... 3-15 3.4.2 Radiation Therapy.. .. .... . .... . . . . ... .... .. .... . . 3-15 3.4.2.1 Teletherapy........................................ .. ..... 3-15 3.4.2.2 Brachytherapy................................ . ........... 3-16 3.4.2.3 Radiophannaceutical Therapy. .. . . ........ ................. 3-19 3.4.3 Diagnostic Nuclear Medicine........................._....... ... . . 3-22 3.4.4 Low-Level Clinical or Medical Research Laboratory Activities. . . .. . . 3-24 3.5 Management Audit and Inspection of the Radiation Safety Program..... . . . .... 3-24 4

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TABLE OF CONTENTS (Cont'd)

Appendices Page A. Agreement States ( As o f April 5, 1977) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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B. Radiation Safety Tasks Involved in Keeping Occupational Exposures l

ALARA..................... ......... ................ ...... .... ........ B-1 C. Summary Checklist of Radiation Safety Considerations in Hospital )

Facility and Equipment Design......................... .. . .......... .... C-1 3

D, . Information Useful for Maintaining Radiation Exposures ALARA. . . .. . .. . . . . . D-1 I E. Radiation Protection Officer Inspection. ............... ............... ... E-1 Table 1 Estimated Minimum Radiation Safety Staffing Requirements for Various Categories of Medical Institutions................. ..... .................. T-1 P

REFERENCES.... ......... . ....... . ..... ....... .. ..... ....... ......... ..... R-1 l

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i PREFACE This report is a draf t companion document to Regulatory Guide 8.18, "Information Relevant to Ensveing that Occupational Radiation Exposures a' Medical Institutions Will Be As Low As Rea-soncbly Achievable." 1 The regulatory guide sets forth some of the major cons 1& rations in establishing management policies, staff, facilities and' equipment, and operational procedures to promote radiation safety in medical or hospital care programs using radioactive materials licensed by the U.S.

Nuclear Regulatory Commission (NRC). This report deals with the same subject, but in more A tail, it is a compendium of good practices for establishing adequate radiation safety programs ir medical institutions. The information presented is intended to aid the NRC licensee in fulfilling the philosophy of maintaining radiation exposures of employees, pctients, visitors, and the public as low as reasonably achievable (ALARA).

Since this is the first NRC report of its Lind to be published for medical institutions, this initial draf t is being circulated widely to obtain comments and suggestions from health professionals and potential users. Please send comments to the Secretary of the Commission, U.S. fluclear Regulatory Conunission, Washington, D.C. 20555, Attention: Docketing and Service Branch.

Sections of this report are numbered in t' e same sequence as sections of Regulatory Guide 8.18 for the convenience of the reader in examining specific topics of interest. Also, while efforts ha e been made to eliminate redundancy, each subsection of this report is designed 1 to include the major radiation safety considerations of interert to the specific type of acti- '

vity. Consequently, the busy doctor, administrator, or health professional will usually, by referring to the table of contents, need to read only a few pages of this document at any one time to obtain the information he or she needs. Additionally, in smaller institutions or pri-vate practice offices where many of the medical activities discussed in this report are not con-ducted, the physician or his or her staff may not need to read certain sections or subsections at all.

ACKNOWLEDGMENT The author wishes to acknowledge the special efforts of Sue F. Gagner for editorial assis-tance and Eileen M. Haycraft for secretarial assistance in the preparation of this report.

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l CHAPTER 1. INTRODUCTION Paragraph 20.l(c) of Title 10, Part 20 of the Code of Federal Regulations (10 CFR Part 20) states that NRC licensees should make every effort to maintain exposures to radiation, as well ,

as releases of radioactive material to unrestricted areas, as low as is reasonably achievable j (Ref. 1). Regulatory Guide 8.10. " Operating Philosophy for Maintaining Occupational Radiat% '

Exposures As Low As Reasonably Achievable," (Ref, 2) sets forth the philosophy and general management policies and programs for achieving this objective of maintaining radiation exposures to employees "as low as reasonably achievable" (ALARA). This report provides information to assist the medical licensee in the design and construction of patient care or laboratory installa-tions and in the planning and supervision of procedures using radioactive materials so as to achieve the objective of keepin:) radiation exposures within medical institutions ALARA.

Since the concept of keeping exposures ALARA is not new in the field of radiation protec-tion, a number of excellent documents that give detailed methods for protecting employees and the public have already been prepared by national and irternational organizations, (See References section of this report.) A list of some of these organizations and their addresses is

. provided at the end of the References section. Practically all of the reconiaendations in these docments, some of them specific to activities in medical institutions, would help to achieve the ALAR l. objective. Many of the larger and established medical institutions heve, of course, been following these standard guides for some time and are already familiar with the ALARA concept.

Indeed, some of these guidelines have originated from the experience gained in the more estab-lished and pioneering institutions. l This report and'its associated guide deal only with radioactive materials subject to

, licensing by the Nuclear Regulatory Commission. The regulations and recommendations of other agencies, including Agreement States, should be consulted in regard to controlling radiation exposures from radiation-producing machines and non-NRC-licensed materials. (A list of Agree-ment States and contact addresses is given in Appendix A.)

Design and planning considerations for ensuring that exposures will be ALARA within restricted areas

• in medical institutions often cannot be separated from considerations of public exposure or exposure to employees, patients, and visitors in unrestricted areas.* Thus, many of the suggestions in this report provide niethods of achieving exposures ALARA in restricted areas while at the same time ensuring that exposures will be ALARA in unrestricted a reas.

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. i Unrestricted and restricted areas are defined in 10 CFR Part 20.

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s CHAPTER 2. BACKGROUND

.The principle of maintaining occupational radiation exposures (as well as public exposures)

"as low as is reasonably achievable" (ALARA) is en extension of an original recom.ndation of the National Committee on Radiation Protection (now the National Council on Radiation Protection and Measurements (NCRP)) in its 1949 report (published in 1954 as Report No.17 (Ref.' 3)). In this early report, the NCRP introduced the philosophy of adopting the conservative assumption i that any radiation e.yposure may carry some risk and recommended that radiation exposure be kept at a level "as low as practicable" (currently referred to as "ALARA") below the recommended maximum permissible dose (MPD) equivalent.

Similar recommendations to keep exposures ALARA have been included in NCRP reports up to the present time (Ref 4), as well as in recomendations of the National Academy of Sciences--

National Research Council (Ref. 5), the Federal Radiation Council (Ref. 6), and other independent scientific and professional organizations (Refs. 7-10).  !

I Since the inception of Federal programs for licensing and regulating radioactive byproducts l of atomic (nuclear) energy, regulations have been written and guidance provided by Federal I agencies with the aim of complying with these recommendations of independent scientific and i professional organizations. Statements of Consideration published with 10 CFR Part 20 (Ref,11) and other regulations have affirmed the prudence of maintaining radiation exposures as far below the regulatory limits as practicable.

The principle of ALARA is now codified as an intcgral part of 10 CFR Part 20, in para.

graph 20.l(c), which states that persons engaged in licensed activities should "...make every reasonable effort to maintain radiation exposures, and releases of radioactive materials in l effluents to unrestricted areas, as far below the limits specified in this part as practicable."

(Ref.1)

Paragraph 20.l(c) also states: "The term 'as low as is reasonably achievable' means as low as is reasonably achievable taking into account the state of technology, and the economics of improvements in relation to benefits to the public health and safety and other societal and socioeconomic considerations, and in relation to the utilization of atomic energy in the public interest." Also, in Part 51 (Ref.12), applicants for licenses to construct or operate produc-tion or utilization facilities are required to include in their environmental reports "... a cost-benefit analysis which considers and balances the environmental effects of the facility and the alternatives available for reducing or avoiding adverse environmental effects, as well as the environmental, economic, technical and other benefits of the facility." Specific cost-benefit analyses have not been required in the licensing of medical institutions in the belief that such a requirement would be an unreasonable interference with medical practice. However, in the licensing of medical institutions, NRC staf f practice has been to review applications to ensure that reasonable radiation safety facilities, equipment, and prc:edures would be provided to maintain exposures to employees and the public at the lowest practicable levels consistent with the provision of good medical care.

Despite the history of independent b ecommendations and regulatory provisions for main-taining exposures ALARA and the initiatives of most industrial, medical, and academic licensee institutions in maintaining averege employee exposures well below regulatory limits, NRC inspec-tions and professional reports in the literature have indicated that in many cases exposures could be further reduced by reasonable efforts and the adoption of good radiation safety practices (Re f. 13). Further, for both private and university-affiliated medical institutions, an adequate radiation safety program can be shown to reduce costs and improve the effectiveness of medical and research programs (Ref.14), in addition to maintaining radiation exposures ALARA.

To assist in the administration of the ALARA philosophy in institutions licensed or applying for a license by NRC, the staff issued Regulatory Guide 8.10 (Ref. 2), which lists for all specific licensees the types of management commitments and radiation protection programs that I would help to achieve the objective of maintaining occupational exposures ALARA. I i

Since there is evidence that a review of radiation safety practices .for medical institutions would be helpful in achieving ALARA exposures (Refs.13 and 15), this report was developed. In (

writing this document, the NRC staff has relied heavily on the comments and suggestions of I affected. licensees and has endeavored to ensure that due consideration is given to the benefi-cial products and services performed by the licensees.

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One general point should be reiterated' regarding the concept of ALARA in relation to medical institutions. Regulatory Guide 8.10 points out that in consequence of the assumption of a linear, non-threshold dose-effect relationship, recommended by the National Academy of Sciences /

National Research Council Committee on the Biological Effects of Ionizing Radiation (BEIR)

(Ref. 5) for prudence in establishing radiation protection programs, the reduction of occupational exposures to individuals by exposing a larger number of employees to the same procedure involving radiation sources may not truly accomplish the objectives of ALARA. Although the assumption of a linear, dose-effect relationship is currently believed to overestimate effects at low doses and dose rates, the distribution of the sane number of person-rems among a larger number of persons could (under the linearity hypothesis) still result in the same total probability of health effects (Ref 5, p. 88). Further, an even more adverse effect might be expected if, in tne prncess of attempting to reduce the average and maximum individual exposures, procedures were adopted that exposed a larger number of persons to an even larger number of person-rems.

There are some circumstances within medical institutions where the principle of reducing person-rems as well as the average dose in rems per person should be considered in carrying out the programs and methods suggested in this report.

On the other hand, the BEIR comnittee report also states: "The public must be protected from radiation but not to the extent that the degree of protection provided results in the substitution of a worse hazard for the radiation avoided. Additionally, there should not be attempted the reduction of small risks even further at the cost of large sums of money that spent otherwise would cb;arly produce greater benefits." This consideration is also taken into account in the concept of ALARA.

Taking into account the above considerations, Chapter 3 of this report discusses some of the main considerations and methods for achieving exposures that are ALARA in medical institu-tions. The licensee could also use the references provided and additional literature cited in these references as appropriate to the nature and extent of procedures involving radioactive materials.

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CHAPTER 3. METHODS FOR MAINTAINING ALARA EXp0SURES The methods and considerations presented in this section are intended to assist the medica) institutions in conducting radiation safety programs that will keep exposures ALARA.

3.1 MANAGEMENT PHILOSOPHY AND ORGANIZATION The management

• of a medical institution has the following radiation protection responsibilities:

1. Keep exposures ALARA for employees, visitors, students and patients not under medical supervision for the administration of radiation or radioactive materials for therapeutic or diagnostic purposes.

2. Avoid significant increases in environmental radioactivity.

Regulatory Guide 8.10 lists a number of actions that the licensee institution can take to carry out these responsibilities, implementation of these actions may be tailored to the size of the institution and the nature and extent of its uses of radioactive material. The manage-ment actions include:

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1. Information and policy statements to medical and hospital staff personnel regarding management's commitment to maintain exposures ALARA;

2. Periodic management audit of efforts to maintain exposures ALARA;

3. Continuing management evaluation of radiation safety staffing and program requirements to achieve ALARA exposures as well as compliance with other regulatory requirements;

4. Management programs to ensure that all hospital staff and employees receive oppro-priate briefings and continuing education and training in radi.ation safety and in the ALARA concept;

5. Delegation of sufficient authority to the Radiation Safety Officer ** (RS0) to enforce l regulations and administrative policies regarding radiation safety; and

6. Administrative direction to ensure that any new construction or modifications to hospital facilities or equipment that may affect the radiation protection of employees, patients, visitors, students, or the public will be made in consultation with the RSO or the qualified individual listed in the license application who is responsible for carrying out the institution's radiation safety program. ,

Regulatory Guide 8.10 provides further discussions of items 1. through 6.. above.

3.2 RADIATION SAFETY OFFICE FUNCTIONS The term " Radiation Safety Office" is used here only to indicate an entity established in the organization to direct and coordinate administrative aspects of the radiation safety program (e.g., supervision, emergency calls, requests for assistance, required records and reports, i training and briefings, radiation safety equipment and supplies). This entity can be maintained '

most effectively in a specific office under the direct or overall supervision of the Radiation SafetyOfficer(R50).

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" Management" is defined as those persons authorized by the charter of the medical institution j

to make its policies and direct its activities. ,

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• • 1 The term " Radiation Safety Officer" is used by many licensees and will be used in this guide j

-to designate the qualified individual who is responsible for carrying out the institution's radiation safety program and who is listed as the " Radiation Safety Officer" on the institu.

l tion's " Application for Byproduct Material License." Form AEC-313. Other titles for this '

individual, such as " radiation protection officer," are equally acceptable. l l

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3.2.1 STAFFING AND ORGANIZATIONAL REQUIREMENTS The staffing and organizational requirements for a medicel institution's radiation safety program can vary widely depending on:

l. The nature and extent of uses of radioactive material or radiation sources; j l

2. The quantity, relative radiotoxicities, and radiation intensities of the sources; I

3. The availability of qualified personnel in the various departments; and 4 The existing organizational and budgetary structure of the institution.

Institutions using only limited amounts of low-radiotoxicity byproduct materials in standard 'i clinical assay or laboratory experiments may be able to carry out the Radiation Safety Office i functions and the responsibilities of the RSO with existing medical staff and hospital personnel.

Institutions using large or potentially more hazardous amounts of radioactive material, however, may require full-time professional staff and technician assistants devoted just to carrying out the requirements of the NRC license and regulations and complying with the ALARA exposure philosophy and recommendations for good radiation safety practice. i l

In these larger medical institutions with more extensive uses of radioactive material, experience has shown that probably tne most important factor in maintaining good radiation protection practices and compliance with regulatory requirements and the ALARA philosophy is the provision of adequate staff, organization, and administrative authority for the Radiation Safety )

Office. There are numerous tasks and duties implied by NRC licenses and regulations.for the j larger institutions, and these tasks and duties should be carried out under qualified professional I supervision with odequate technical and clerical assistance. In addition, the RSO or individual j delegated by the RSO to carry out the duties of the Radiation Safety Office can function most i I

effectively if located in the organization in such a way and with sufficient authority that other hospital duties and responsibilities will not be allowed to infringe on his full devotion to the radiation safety program.

A sample outline of the various tasks of a typical Radiation Safety Office is presented in Appendix B. The extent of time and effort required for each task varies with the size of the hospital and the nature and extent of radioactive material usage. It is important that manage-ment review periodically the staffing requirements for each of these tasks and provide the necessary personnel to establish radiation safety program requirements. Management evaluation of program performance, at least on an annual basis is also important for providing proper i direction and support.

Table 1 shows estimated minimum radiation safety staffing needs for various categories of medical institutions. The categories were selected according to the nature and extent of the medical institution's procedures with radioactive sources and radioactive materials. More specific estimates may be made by the management of each specific institution according to the time required for the tasks indicated in Appendix B.

The minimum time estimates of Table 1 take into account only the ef fort needed to comply with NRC regulatory requirements and the ALARA philosophy. They do not take into account all of the professional and time requirements of larger hospitals for carrying out such radiological physics or medical physics and engineering functions as radiation therapy source calibrations, radiation therapy treatment planning, nuclear medicine instrumentation checks, maintenance and repair of a variety of hospital electronic and scientific equipment, design and selection of general medical equipment, or other hospital engineering functions required in the planning and efficient utilization of hospital facilities.

3.2.2 RADIATION SAFETY PERSONNEL QUAllFICATIONS For the same reasons that staffing requirements vary widely between different medical institutions, qualifications of those supervising or carrying out the radiation safety program will also vary. In Category I hospitals (as indicated in Table 1), radiation safety surveil-lance and recordkeeping requirements may be assigned as a part-time function to one of the radiologic technologists who has had training in hospital radiation protection principles. This technician could then serve as the radiation safety technician under the supervision of the RSO, who may be a member of the full-time medical staff of the Nuclear Medicine Department or the Department of Radiology. Other arrangements may also be appropriate for a hospital using limited quantities of the less radiotoxic materials.

J As indicated in Table 1, larger institutions may require either part-time or full-time orofessional staff trained and experienced in radiation protection theory and practice. Larger institutions should consider the need for at least one full-time professional health physicist 3-2  ;

(or radiologica'l physicist) with at least two years of experience in a hospital radiation safety

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program in addition to an education in one of the basic sciences or engineering sciences related to radiation protection. The larger programs may also require personnel with advanced training in radiation health or health physics at the graduate level.

Whatever the organizational structure and staffing provided for the radiation safety program, it' is important that management ensure that personnel training and qualifications are adequate for the program and for the effort and expertise required to carry out the tasks in Appendix B.

The qualifications of radiation safety persomel are reviewed by the Radioisotopes Licensing

- Branch of NRC upon receipt of a new or renewal application or when there is a change in radiation safety personnel.

3.2.3 SPACE AND EQUIPMENT REQUIREMENTS The Radiation Safety Office should have adequate space to carry out the following kinds of functions:

i. Receive, process, and file regulations and licensing correspondence.

2. Prepare reports and records of surveys and personnel monitoring as required by 10 CFR Part 20.

3. Conduct radiometric measurement of smear tests from contamination surveys and source leak tests.

4 Instruct and brief personnel as required by 10 CFR Part 19.

5. Calibrate, maintain, and repair radiation safety equipment.

6. SHck radiation safety supplies for labeling, surveying, decontamination, and personnel protection and monitoring.

7. Process orders for licensed materials and receive and distribute such materials, a

8. Store radioactive wastes and sources not in use.

9. Calibrate radiation safety and survey equipment and check the calibrations of other

' hospital radiation sources.

10. Decontaminate personnel, clothing, and equipment.

1 in addition, the tasks listed in Appendix B should be examined for other activities that may require specific space allocations in the larger hospitals.

In planning and providing f acilities, guides of professional and scientific organizations already referenced should be consulted for detailed considerations. The RSO also can work with competent architects, engineers, and nospital administrators to ensure that the following con-siderations are emphasized:

1. Adequate shielding is necessary for source and waste storage areas to maintain limits of radiation exposure rates for unrestricted areas (10 CFR Part 20). It is good practice to locate storage areas as far away as possible from the usual location of employees and other areas frequented by persons both inside and outside the hospital.

i 2. Waste and source storage areas (including locations where Tc-99m generators are stored) require adequate ventilation to protect employees against the routine or accidental buildup of l- air concentrations of radioactive material when activity levels and processes are such that significant buildup of air concentrations is possible (Ref.16).

3. Office space for' administration of radiation protection programs is needed as far j away as practicable from areas where radiation sources are used. Ideally, such space would be located to reduce ambient external radiation levels to levels approaching natural background, while considering at the same time the need for accessibility of facilities to radiation safety

( staff and the need for surveillance of certain areas by the staff.

4. Ventilation of offices and other areas occupied by personnel is required to minimize the possibility of radiation exposure resulting from airborne concentrations of radioactive materials. . Good ventilation design principles (Ref.17)'are necessary here even though radio-l active materials would not generally be stored in close proximity to areas frequently occupied by personnel.

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5. .. Adequate space is needed to avoid unnecessary exposure to personnel during counter calibration or-instrument repair. Separate areas may be required for instrument or source calibrations at the higher. radiation levels and for low-level radioactivity counting and evaluation.

. A minimum amount of rarliation safety equipment will also be needed for any medical institu-i tion licensed to possess or use byproduct, source, or special nuclear material. Appropriate budgeting for this type of equipment can best be done with the advice of a professional health physicist. since an understanding of instrument specifications is required to determine instru-ment needs for the tasks presented in Appendix B. Available commercial instrumentation is always in a state of rapid technological change; therefore, specific equipment requirements are beyond the scope of this report. Licensing guides provided by the Radioisotopes Licensing Branch (RLB) will indicate to the applicant what information should be included in the appli-cation regarding radiation safety equipment. The information submitted will be reviewed by the RLB to ascertain its adequacy in meeting regulatory and license requirements for the scope of activities proposed by the institution. i s

3.2.4 TASKS AND PROCEDURES As noted earlier, a list of the types of tasks carried out by a Radiation Safety Office in order to provide good radiation safety surveillance and meet regulatory and license conditions is presented in Appendix B. The RSO and the radiation safety staff should conduct surveillance programs and investigations to ensure that occupational exposures are as far below the specified limits as is reasonably achievable. Additionally, they should be vigilant in searching out new and better ways to perform all radiation jobs with less exposure. Important aspects of these responsibilities are listed below:

1. The Radiation Safety Office should be familiar with

a. The origins of all radiation exposure in the hospital, according to location, type of procedure, and job categories and

b. . Trends in exposures, as well as new practices and procedures.

This awareness will help the office devise reasonable ways of influencing these trends toward lower (ALARA) exposure levels.

2. In seeking to reduce exposures. the radiation safety staff should

a. Investigate unusual exposures and determine the causes,

b. Take steps to reduce the likelihood of similar occurrences,

c. Record the results of such investigations and conclusions or corrective actions.

d. Periodically review written procedures affecting radiation safety,

e. Periodically survey all procedures and areas involving possible occupational radiation exposures, as required by 10 CFR Part 20.

f. Ensure that indicated changes are properly implemented.

9 Encourage all users of radioactive materials and their employees to maintain their own daily surveillance of all activities involving radioactive material and provide procedures for receiving and evaluating employees' suggestions for improving radiation pro-tection practices.

h. Provide briefings and training sessions to inform employees of radiation pro-tection practices, as well as to receive their current ideas and suggestions.

1. Provide adequate radiation monitoring equipment and supplies for the Radiation Safety Office's own surveillance activities, as well as for personnel monitoring and daily

, surveillance to be carried out by the users and employees.

J. Maintain the supply of this equipment for routine use by the office as well as l

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Lk. Maintain monitoring instruments' in good working order and calibration.

1. Ensure that users and employees underttand the proper methods of care and opera-tiori of equipment assigned to them for their routine use in surveying their own activities.

3.2.5 ADMINISTRATIVE AUTHORITY ,

The Radiation Safety Office, supervised by the RSO, should have the administrative authority to enforce medical staff bylaws and rules and procedures pertaining to the institution's radia-tion tafety program as prescribed by management, as well as the responsibility of carrying out the tasks listed in Appendix B. The administrative authority provided to the Radiation Safety Of fice should provide for the 'need to temporarily suspend certain activities involving licensed radioactive materials when they are deemed unsafe, consistent with noninterference in life-1 saving medical procedures that may warrant overriding priWV before the radiation safety problems can be alleviated.

3.2.6 MEDICAL ISOTOPES (OR RADIATION SAFETY) COMMITTEE

, The Chairman of the Medical Isotopes Conmittee (required by 135.11 of 10 CFR Part 35) should prepare for and conduct Medical Isotopes Connittee meetings. The RSO should be a member of the Conpittee and may assist the chairman in conducting meetings and maintaining committee records. Any institution required to appoint such a committee as a condition of its license should call meetings at least quarterly. Every member of the Medical Isotopes Committee should be invited. The purposes of the meetings should include the following:

i 1. To approve the acquisition and use of radioactive materials;

2. To discuss any radiation safety problems requiring a general solutien;

3. To determine whether current procedures are maintaining exposures ALARA; and

4. To audit the radiation safety program to ensure that it meets all the goals and requirements presented in Sections 3.2.1 - 3.2.5 above.

The need for a management audit of the radiation safety program is discussed in Section 3.5 of this document.

All Medical Isotopes Committee meetings should be documented by a record of minutes approved by committee members and filed as part of the radiation safety record system within 60 days )

following a meeting.

3.3 FACILITY AND EQUIPMENT DESIGN 3.3.1 1 GENERAL CONSIDERATIONS One of the first considerations in keeping radiation exposures ALARA is proper planning of the' hospital facilities and equipment required for the medical uses of radioactive material )

(Ref. 18, page 227). Since the methodology for planning and designing such facilities extends I over several fields of science and engineering, optimum design for keeping radiation exposures l ALARA as well as for efficient delivery of medical care requires a joint effort between the '

hospital administration, personnel working in these areas, health physicists, architect-engineers, ventilation design engineers, and other engineering disciplines.

Health physics input is needed for areas where radioactive materials are handled, where radiation-producing equipment is operated, and where radioactive materials and equipment are ]

stored, shipped, repaired, or discarded to the environment. These places are in addition to the Radiation Safety Of fice facilities and equipment discussed in Section 3.2.

The design of facilities and equipment will depend not only on hospital and medical care considerations, but also on the nature and quantity of radioactive materials invclved (Ref s.18 and 16) and the relative potential for external and internal radiation exposure. Some of the major aspects of planning and design that should be considered are given in the following sections.

, 3.3.1.1 Space Layout important space layout considerations include: l l

1. The need for access to radiation or radioactive materials areas by medical staff, l employees, patients, visitors, and others; ]

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2. Ventilation requirements; l l

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3. Floor loading in the case of heavily shielded sources;

4. Receipt and shipment of radioactive materials; and

5. Outpatient parking for some radiation therapy and nuclear medicine patients.

In general, facility layout should keep employee exposures ALARA while at the same time ensuring that exposure is not thereby increased to other persons.

In cases where the potential for inhalation or ingestion of radioactive materials is significant or where radioactive gases are used, the placement of facilities will be influenced by the availability of ventilation ductwork that can lead from the facilities without carrying .

radioactive materials to other areas where they might contribute to internal exposure to unsus- l pecting persons, l

3. 3.1. 2 Shielding l Permanent shielding may be needed in some cases for walls, floors, and ceilings to provide protection against radioactive materials currently housed in the institution, as well as radio-active materials that might be introduced into the area by future medical care requirements.

Occupancy and use factors should be taken into account as recommended in NCRP handbooks (Refs.19 and 20), but such factors should be chosen with the principle of ALARA in mind. The Radioisotopes Licensing Branch, NRC, should also be consulted during the planning and design sta9e to obtain specific guidance for obtaining a license for the particular quantities and uses of radioactive material involved.

3,3.1.3 Caution Signs and Interlocks l l

In accordance with good radiation safety practice and in compliance with 10 CFR Part 20, 6 20.203, access to certain areas should be controlled or restricted by the use of prescribed caution signs, signals, and interlocks. The requirements for, and the proper location of, such caution signs, signals, and interlocks should be carefully considered to ensure that neither employees nor others spend more time than necessary in certain areas, do not in any case exceed regulatory limits of exposure, and do not enter specified high-radiation or radioactive materials areas except under prescribed circumstances (Ref s.1, 20, and 21).

3.3.1.4 Ventilation Ventilation requirements should be considered for areas where radioactive gases (e.g.,

xenon-133) are stored or used or where other unsealed radioactive materials may enter the work environment in volatile or aerosol forms. The levels of such materials may necessitate special hoods or gloveboxes (Ref.16). The' recommendations of health physicists and engineers should be sought in this regard. Design of any necessary local exhaust hoods or fume hoods and their flow rates should be coordinated with the overall design of the general office or clinical air requirements.

In designing ventilation to guard against inhalation or ingestion of radioactive materials in work areas, the Medical institution should also consider the need to prevent exhaust air or effluents from exposing persons in unrestricted areas. For example, a nuclear medicine depart-ment using Xe-133 carrying out its own radiopharmaceutical operations may want to consider a location in the corner of a top floor to save the costs as well as engineering dif ficulties of transporting contaminated air through long ductwork. The exhaust vent should be located to provide adequate meteorological diffusion and dilution to meet 10 CFR Part 20. I 20.106 require-ments for effluents to unrestricted areas as well as ALARA exposure considerations for the public. In some cases it may also be advisable to include specific types of filters of air cleaners for the exhaust air, in general, the release point of exhaust air from ventilatior, systems should be at least 10 meters from any window, air intake system, or point of occupancy by members of the public in order to provide meteorological dilution by a factor of 10" or more.

In any work area where radioactive gases or aerosols are used outside of a glove box or fume hood, adequate ventilation should be provided to meet 10 CFR Part 20, 5 20.103 requirements for exposure to individuals to concentration of radioactive material in restricted areas. Such areas should be under negative pressure as required to ensure that contaminated air is not carried to unre Q icted areas.

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3.3.1.5 Fire Control The need for personnel exit and for closing the facility to prevent the spread of radio-active materials should be considered for areas where laboratory procedures could result in the dispersal of radioactive materials in case of a fire. Provision should be made for local showers, where necessary' Chemical fire extinguishers should be conveniently placed for employees who

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may be able to provide early fire and contamination control. However, for the vast majority of medical institutions, emergency procedures and training should include immediate fire control as a priority item without interruption by other considerations of radioactive contamination.

3.3.1.6 Special Laboratory Design Requirements There are many sources of guidance and information on design of laboratories for handling radioactive materials (Ref.16). Consideration should be given to providing laboratory surfaces that may be easily cleaned and decontaminated daily to maintain minimal contamination levels and radiation exposures. In laboratories where radioactive contamination may frequently reach lab surfaces and be picked up or inhaled by employees, a fixed radiation monitor should be provided for employees to monitor their hands, feet, or clothing routinely before leaving the laboratory.

The same monitor may be used to maintain a general awareness of the ambient radiation levels in the work area. Additional portable Geiger counters or other radiation monitoring equipment may also be desirable.

In general, there is no justification (in hospitals) for any procedures using quantities of radioactive material sufficiently radiotoxic that potential air concentrations may reach levels near or at the limits of 10 CFR Part 20. Thus, there is generally no need for additional respiratory protection such as face masks or supplied air hoods. Ventilation and contamination control should be designed to maintain air concentrations and contamination levels as low as reasonably achievable.

Nuclear medicine departments that perform xenon-133 studies may require special apparatus for dispensing and collecting the xenon-133. A number of collecting systems are commercially available, but those that collect the xenon-133 and hold it for decay are preferable to those that merely collect it for later release to the environment. Specific guidance for the use of xenon-133 in nuclear medicine is available from the Radioisotopes Licensing Branch.

Other considerations are:

1. Special sinks may be needed for rinsing and disposal to sewage systems of trace amounts of radioactive material from laboratory equipment. (Part 20 of 10 CFR specifies the limits for such disposal and requires that a record be maintained of effluent dilution by the volume of sewage effluent from the institution.)

2. Design of plumbing and sewage systems should take into account the need to avoid buildup of radioactive contamination in areas where persons may be exposed to external radiation from these materials and to avoid the possibility of these materials finding their way to intake drinking water or water supply sources.

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3. Temporary storage of the bulk of radioactive wastes of short half-life may be needed to allow for decay of the radioactive material in appropriate containers placed in remote or l shielded areas.

4. Equipment or apparatus should be provided for accumulating long-lived liquid radioactive wastes in absorbent material that can be included in the radioactive waste sent to commefcial disposal firms.

3.3.1.7 Storage, Source Controlu and Inventory Institutions that order a number and variety of sources of radioactive material may find it easier, less costly, and more secure to provide a centralized storage room for racioactive materials not in use or used only occasionally. Such a storage facility would normally be located in a remote ground-level area where a common storage vault can be constructed with minimum construction, space, and materials costs.

A central storage facility is helpful in keeping exposures ALARA, since it may result in a decrease in the amount of radioactive material stored in laboratories occupied by personnel. It can also minimize the loss or inadvertent misplacement of radiation sources.

Additional shielding may be needed in the walls of the central storage area to protect persons in unrestricted areas. Design considerations include:

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l. ~ Vault and shield design that will protect employees entering the area as well as those in adjacent unrestricted areas; j 2. Provision for some ventilation of the area if volatile or gaseous radioactive mate-rials escape into.the room air;  !

I i 3. Provision for monitoring the room air and ef fluents to unrestricted areas; 4 The possible need for a fixed gamma alarm or sign &l to warn employees of radiation

levels at places where employees frequenting the area could receive appreciable l radiation exposures;

5. Surface or strippable coatings that can easily be decontaminated;

} 6. Adequate floor loading requirements toi support the required shielding materials; and 4

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7. An adequate lock-and-key system for controlling the area, i i  !

Where space is limited, some calibration facilities may be included in the storage area.

If so, a shielded area should be provided for the person carrying out the calibrations, and

! provision should be made for raising and lowering 'the source remotely and placing instruments to j be calibrated in various positions without onnecessary or significant exposure of the operator.

The source should be exposed only when int rument calibration is being carried out under the supervision of a member of the radiation safety staff.

j 3.3.1.8 Shipping and Receiving I In some medical institutions, unnecessary exposure of personnel has resulted from the need j to transport packages of radioactive material long distances from the receiving area to the j user. Medical institutions should therefore: )

i 1 Plan specific radiation source storage areas for day, night, and weekend deliveries so that sources may be received at any time and placed in a secure location where they will not cause unnecessary exposure to personnel while awaiting survey by the Radiation Safety Office or the user.

! 2. Make available a cart or carrier for transporting these packages that will maintain an I f adequate distance between the courier and the radioactive material package.

3. Set aside some space in the receiving area for an initial survey and wipe test of each package to avoid transporting a contaminated package through unrestricted areas of the hospital.

l 4. Locate shipping and receiving areas.so as to d

j a. Minimize the time required for transporting radioactive material to areas where

! it is to be used and b, Avoid the need to transport radioactive material through crowded areas or areas

occupied by personnel, patients, or visitors.

3.3.1.9 Equipment Considerations General features that should be considered for equipment that will be used for handling, l .

containing, or contacting radioactive materials are:

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1. Surfaces should be easily cleaned and decontaminated in case unsealed radioactive j material is released.

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2. Equipment should be so designed as to optimize the ease of carrying out procedures s where personnel are exposed to radiation, thereby minimizing working times, and to maximize

!- distances of nersonnel from the radioactive materials with which they are working, consistent I with the purposes of the procedure.

3. Equipment should operate in such a fashion that it does not damage radiation sources 5

and release radioactive materials if it fails. -

4. Adequate shielding should be provided as part of the equipment where feasible.

5. Appropriate caution signs, symbols, signals, and alarms should be provided as part of the equipment to meet the requirements of 10 CFR 204203 and recomended standards of the medical physics profession (Refs. 19 and 20).

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In general, equipment'to be used'with radioactive materials or radiation sources should be selected or designed in consultation with the Radiation Safety Officer, using health-safety principles and engineering data already developed by the health physics and nuclear engineering professions (Refs. 16, 18-20; 22-26). A brief checklist of the more important radiation safety considerations in hospital facility and equipment design is given in Appendix C.

3.3.2 RADIATION THERAPY EQUIPMENT AND FACILITIES Specific licensing guides are provided for licensed radiation therapy programs, and the Radioisotopes 1.icensing Branch reviews the safety aspects of facilities and equipment before issuing a license. Therefore, the planning and design of radiation therapy facilities should consider licensing guidance from the Radioisotopes Licensirig Branch as well as recommendations of scientific and professional organizations and requirements of NRC (or state) regulations (Refs. 1, 19, and 20). In designing shielding for teletherapy treatment rooms, medical institu-tions should consult NCRP Handbooks 33 and 49 (Refs.19 and 20) for reconinended design details, specifications, methods of shielding against direct and scattered radiation, and general principles ,

of radiation safety design. Although occupancy &nd use factors reconsnended by NCRP may be taken into account in thcrapy facility design, experience has shown it is reasonable to set a design objective of reducing occupational exposures to 10% or less of the limits of 10 CFR Part 20.

In addition, the institution stould:

1. Protect each teletherapy treatment room from inadvertent entry by the following means:

a. Provide a door interlock that allows a " Beam On" condition only when the door is

b. Connect this interlock in series with a green light to indicate its proper connection when the door is closed.

c. Provide independent back-up caution lights on the console, above the door, and inside the treatment room to indicate the " Beam On" condition to radiotherapy technologists and other staff members,

d. Establish a procedure for checking whether everyone except the patient is out of-the area before the door is closed and the beam is turned on.

e. Install independent caution lights near the entry inside teletherapy treatment rooms to provide a warning to the therapy technologist or others entering the room in case the door interlock system fails while the beam is in the "on" condition. Non-flashing lights have been found to be acceptable to patients for this purpose. When these warning lights are acti-vated by an independent, gamma-ray-sensing, radiation detector they can also be used to check the general operation of teletherapy equipment by viewing the condition of the warning light through the viewing window or closed-circuit television. ,

2. Consider leakage through the teletherapy head with the source in the "on" position when designing shielding. Data provided by the manufacturer of the teletherapy machine should be used for this purpose. Ordinarily, it will be possible with modern equipment to shield this leakage radiation with the shielding provided to protect against scattered radiation. However, this should be examined specifically becausetthe leakage radiation may be more penetrating than ,

the scattered. In installations where an existing teletherapy unit is being replaced by a newer one of higher intensity, actual radiation survey data for the existing unit should be used in addition to design data in the literature in order to provide an optimum design of the renovated facility. (License applications for teletherapy usually require specific shield and facility design details, and license conditions require a survey of an installed teletherapy unit prior

, to use.)

3. Design areas adjacent to the treatment room sc es to maintain exposures ALARA to >

personnel, patients, or visitors who are not associated with the radiation therapy department.

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' Reduction of occupational exposures to radiation therapy personnel should not.be achieved by design provisions, procedures, or planning beam orientations that would increase exposure to persons in unrestricted areas.

Additional recommendations regarding tne maintenance of safety provisions and cali-brations of teletherapy devices are available f rom other independent standards organizations (Refs. 21, 27, and 28).

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3.3.3 NUCLEAR MEDICINE FACILITIES.

Nuclear medicine facilities and equipment should also be planned and provided in coordina-tion with appropriate health physics and engineering advice, using the latest recommendations of '

professional organizations and requirements of the NRC Radioisotopes Licensing Branch. In-addition to the considerations listed in Section 3,3.1 above, emphasis on'the following space and equipment requirements will help to ensure that exposures are ALARA:

1.' Allow sufficient space for personnel operating nuclear medicine equipment to be at least one meter, and preferably two meters from ary patient ondergoing the scanning procedure in the vicinity (Refs 8,15 and 24) whenever the condition of the ratient permits.

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2. Allow adequate space for stretcher patients awaiting scans, as well as outpatients. ]

Dosed patients awaiting scans may cause radiation levels on the order of 10 mR/hr or more. They may need to be segregated from the general waiting area to reduce radiation exposure to recep- I tionists and persons passing through the area such as orderlies and aides. I 1

3. Locate physicians' offices and other areas occupied by personnel within easy access of j the laboratory where radiopharmaceuticals are stored and prepared, but far enough away (several '

I meters is usually sufficient) so that exposures from radiopharmaceuticals in storage and radio-active wastes will be minimized. l l

4. Provide adequate shielding in the laboratory for stored radiopharmaceuticals. Partial shielding should alsc be provided for employees when they are preparing radiopharmaceuticals from ,

reagent kits'or preparing dosages for patients. Portable or movable shields may be necessary I within the diagnostic areas to shield employees while they are operating equipment or waiting f or patients or results. Shielding should also protect any radiation-sensitive dose calibrating equipment or other nuclear medicine counting or imaging equipment.

5. Provide an adequate supply of syringe shields, bottle shields, tongs, and forceps near the place of dosage preparation to minimize hand and body exposures of nuclear medicine personnel. l Provide additional exhaust ventilation in the laboratory near the radiopharmaceutical '

storage area to protect against buildup of air concentrations of radioactive material from gases  !

or from accidental release or spills of radiopharmaceuticals, in depa %ients handling potentially I hazardous quantities of radioactive material (Ref.16) where release of raaiopharmaceuticals is l possible or in departments where preparation of radiopharmaceuticals from basic reagents is j carried out, this additional ventilation should be provided through a hood in the laboratory that is maintained at a linear face velocity of about 150 feet per minute. This additional flow rate should act as a sink for air from the rest of the derartment and can be used to reduce rapidly any air concentrations from accidental spills or breakage of vessels containing such volatile or gaseous materials as xenon-133. In general, the architectural layout should consider the need for air to flow f rom areas of lower radioactivity toward areas of higher radioactivity unless each space can be separately ventilated.

When a hood is provided, the Nuclear Medicine Office or Radiation Safety Office should maintain a calibrated velometer or other air flow meter to check hood flow rates at least twice per year.

Exhausts from the hood should be vented above the hospital roof, where possible, or at a point outside the hospital that is removed by at least 10 meters from any source of intake .

air, open windows, or persons in parking lots or unrestricted areas, j

6. Provide a special waste receptacle for used syringes and other radioactive wastes in the nuclear medicine laboratory near the dosage preparation area. This waste receptacle should be large enough to contain at least a one-week supply of waste adequately without osarflow. It should also have a removable pail that has a special cover that can be used while the pail is carried and is shielded by at least a 1-mm thickness of lead to protect employecs carrying the pail to the waste storage area. This 1-mm thickness of lead will at least protect against the j Tc-99m gamma radiation. The lead may also protect persons working in the laboratory from a i substantial portion of potential occupational exposure. I 4

An additional receptacle should be provided in the nuclear medicine laboratory for nonradioactive wastes so that radioactive waste volumes will be minimized.

7. Locate a permanently fixed GM counter and rate meter immediately outside the entrance j to the nuclear medicine preparation laboratory so that employees can check for hand contamination  !

when leaving the laboratory or the nuclear medicine department. This fixed monitor should i preferably have a removable probe that can extend low enough to monitor shoes. I i

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Although contamination levels up to 10,000 disintegrations 'per minute per 100 square centimeters will not necessarily . indicate a serious ingestion or inhalation hazard for the radionuclides used in nuclear medicine, contamination levels should be minimized, and any loose contamination found on bboratory surfaces or clothing should be immediately cleaned up in order to minimize external radiation exposure and prevent gradually increasing interference with the background levels of calibrators and nuclear medicine equipment, lhe fixed GM counter and monitor will also serve to provide nuclear medicine personnel with an added awareness of ambient radiation levels and the continuing need to keep them ALARA.

Records should be kept of the daily ambient levels so that any long-term, as well as short term, increases in radiation background levels will be noted, investigated, and corrected where feasible.

8. Design all floors and surfaces according to good laboratory design practice for handling radioactive materials and for easy decontamination as described in References 16 and 22,

9. Provide individual, labeled lockers for laboratory coats that may be contaminated.

Clean change rooms should also be available. Stations remote from radioactive materials should i be provided where personnel monitoring devices may be lef t at the end of each day.

- 10. Provide finger badges or dosimeters and bady badges for monitoring occupational expo-sure of personnel whose hands may receive more than 10 percent of their permissible occupational dose. These dosimeters shoulo be lef t at a station accessible to the Radiation Safety Office for prompt collection at appropriate intervals as designated by the Radiation Safety Officer. A place for a control desimeter should be maintained at the station where personnel monitoring devices are turned in.

3.3.4 IN-VITRO CLINICAL AND RESEARCH LAGORATORIES Many of the radionuclides used in experimental or clinical work emit very little or no ganuna radiation per disintegration. Clinical or research laboratories in medical institutions should therefore be able to maintain occupational radiation exposures to the average employee well below 10% of the permissible levels of 10 CFR Part 20. This is true also of internal dose conunitments from inhaling or ingesting radioactive material.

Facilities in these laboratories will be evaluated by the Radioisotopes Licensing Branch l for design features that ensure ALARA exposures as well as compliance with regulatory require- )

nients according to types, forms, and quantities of radioactive material to be possessed and I used. Recommendations for good laboratory design can be found in a number of references (see Refs.16-20, 22-26). Some of the more important considerations are: )

1. Provide' smooth, easily decontaminated laboratory surfaces for benches, sinks, walls, and floors.

2. Provide easily discarded bench paper, absorbent on the top surface only, for catching and easily disposing of small amounts of contamination that may drip or be removed from labora-tory apparatus and glassware.

3. Design laboratories with a minimum of sharp corners or cracks where radioactive material can lodge.

4. Design plumbing, traps, and ductwork so that radioactive contamination will not build up and create sources of external radiation exposure or cross-contaminate drinking water or air-supply lines.

5. Provide separate lockers for hanging laboratory coats, and consider providing special laboratory shoes where floors are likely to be contaminated. Uncontaminated street clothes should be worn when leaving the laboratory for lunch periods or for any other reason. Appro-priate change areas should be provided so that radioactively clean clothing may be separated f rom contaminated clothing. Showers should also be located in the change areas so that employees can minimize transport of radioactive contamination outside the Nuclear Medicine facilities.

6. Provide special locations for depositing body and finger dosimeters in an area of normal background radiation when leavin9 the radiation area.

7. Provide specially labeled radioactive waste cans for radioactive laboratory wastes.

These cans should be shielded as necessary to avoid a buildup of external radiation exposure levels in the laboratory. The cans should also be placed convenient to the area where the radioactive waste will be generated, but as far away as possible from positions frequently occupied by personnel.

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-8. ' Designate special sinks' to receive any small amounts of radioactive washings or. effluents.

Keep records of the estimated amount of radioactive waste disposed of in these sinks and the total sewage effluent into the connecting sewer in order to ensure compliance with the limits of 10 CFR Part 20, 5 20.303. These sinks should be connected directly to the main pipe; connections to open channels or any unnecessary devices that may accumulate radioactivity should be avoided.

Sink taps should be designed where possible for. operation by a foot, knee, or elbow rather than by hand .

9. Reduce laboratory furniture to e minimum and be sure that it is easily washable. 4 Dust-collecting items should be minimized and laboratory surfaces should be maintained as dust- I free as possible, since dustiness tends to increase the spread of radioactive contamination. .

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10. Provide adequate lighting for laboratory work areas to help ensure safe handling of I radioactive materials.

11. Provide adequate ventilation, including hoods for processing certain quantities 1 (Refs.16 and 22) of radionuclides or closed gloveboxes for experiments or analytical work '

involving certain larger quantities of the more radiotoxic materials.

12. When possible, design laboratory ventilation to be under the control of laboratory 1 supervisors 50 they can monitor and control the total air flow into and out of the laboratory. l Fume hoods should maintain a face velocity of 150 linear f t/ minute and should be designed to {

avoid eddy currents that would disperse radioactive materials outside the hood area. '

l Consideration should be given to providing adequate filtration of both intake air and air exhausted from the fume hoods or general laboratory area in order to avoid increasing j environmental exposures. The ventilation system should be designed and checked during and af ter )

construction with the assistance of an industrial hygienist or health physicist.  ;

1 Provision should be made for shutting down the ventilation system in the event of '

accidents if necessary in order to contain radioactivity. 1 1

Consideration should also be given to the influence of opening doors or windows and i adjusting the degree of opening of hood doors. Exhaust fans used in hoods should be placed only on the exit side of the exhaust filters. In some new designs, hoods and gloveboxes are provided {

with exhaust fans pulling air downward rather than upward, thus providing additional protection l against re-suspension of particulates. Gas, water, and electrical appliances should be operable from outside the fume hood to minimize air flow disturbances.

Internal surfaces of hoods and exhaust ducts should be as easy to clean as possible.

Before cleaning, any ducts or facilities that may have built up contamination should be first checked by the Radiation Safety Office staff. Exhaust filter design should consider contamina-tion buildup, possible need for filter shielding, and ease of filter removal to minimize expo-sure during filter change.

13. Provide suitable, easily cleaned, drip trays for carrying out manipulations of radio-active materials where spillage may occur. These drip trays may also be covered with absorbent, plastic-backed (or similar design) material to soak up minor spills. The absorbent materials should be changed when measurable radioactivity has built up or when they are unsuitable for further work, and these materials should be treated as radioactive wastes.

14. Provide protective clothing, including plastic disposable or rubber gloves, for persons l working with radioactive materials. (Disposable gloves should be changed frequently.) Also i provide equipment for monitoring clothing before laundering. Potentially radioactive laundry '

and radioactive wastes should be turned over to the Radiation Safety Office for further disposi-tion. Again. the available reference material on design of laboratories for handling radioactive 1 i

materials should be consulted (Refs. 17, 21, 29-31). Also, cdditional recommendations are available for carrying out in-vivo experiments with animals (Ref. 4).

When proper containment or ventilation is provided to prevent or reduce internal exposures ALARA, external exposure should also be easily made ALARA. However, there may be instances in some laboratories of medical institutions where additional shielding against beta radiation or l gamma radiation is required. -The references cited and professional health physicists should be I consulted to plan these requirements when necessary, including adequate loading strengths.

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,. 3.4 SAFE WORK PRACTICES AND PROCEDURES 4 r

3.4.1 GENERAL PRINCIPLES i

l References 8, 10, 16',19-26, and 32-35 suggest work practices and procedures that will help' to ensure that exposures are ALARA. In addition, the license applicant should contact the Radioisotopes Licensing Branch regarding the specific items and radiation safety requirements to be addressed in the license application for his or her particular institution.

The following practices are particularly important in keeping exposures ALARA: ,

3.4.1.1 Periodic Inventory and Control of All Radiation Sources Many of the more serious occupational exposures, as well as patient exposures, have resulted from loss of radioactive material, which then may inadvertently expose unsuspecting persons or be subject to improper usage by unauthorized persons (Ref.18). The following procedures can be used to guard against these problems:

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1. ' A frequent (at least c,uarterly) inventory should be made of all radioactive sources.

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The inventory should be combined with an inspection to ensure proper labeling (see 10 CFR Part 20, 1 5 20,203).

2. Sources should be secured within locked rooms or storage areas when authorized users  ;

or their responsible employees are not present. Special shielded vaults should be provided in j the storage area for sealed sources, and small brachytherapy. sources should be maintained within 'l separately identifiable holes or slots within the shielded vaults or containers. Each slot .1 sbould be identified as to quantity and type of radioactive material, and a coding and control system should be devised to prevent errors in retrieving or replacing individual sources. All scaled sources should be s tored and secured immediately af ter use. Unsealed sources should also be stored and secured, with appropriate shielding and also proper ventilation in situations i

where significant quantities of environmental contamination are possible.

3. A station' log should be placed near the exit to each source storage area. Each source removed from the area should be signed out on the leg and signed back in upon its return to the proper vault location. Temporary storage locations during source cleaning or testing should  !,

also be noted. All entries in each station log should be signed with time, date, source identi- I fication, and activity. The source log should be checked regularly by the Radiation Safety Office. ]

4. The Radiation Safety Office should maintain a central inventory of all sources in the institutio,n and records to show that the institution has not exceeded any possession limits of its license.

I S. Source storage areas should be f requently surveyed by users, who must be authorized according to license conditions.

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6. Doors to source storage areas should be properly locked and posted as required by 10 CfR Part 20, a 20.203, 7, Areas surrounding source storage areas should be frequently surveyed and ambient l

j. intensities in the vicinity of storage locations should be posted if they exceed 0.2 mrem / hour l in any area frequented by personnei.

l 8. Inventory procedures should provide that the RSO will be alerted if all sources are t not returned within a specified time in order to avoid sending patients home with brachytherapy l devices still in place.

l 3.4.1.2 Shielding l

l, All radioactive material not in use should be completely shielded 50 that exposure rates in any area that may be occupied by personnel will be well below the levels for unrestricted areas of 10 CFR Part 20. Radioactive materials that are in use should be unshielded only in the direction necessary for the use and to the extent that accessibility to the source is necessary.

Sources should be in an unshielded state only when under the direct supervision of an authorized l user or his responsible employees.

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3.4.1.3 Control of Contamination Radioactive materials in unsealed form or undergoing chemical or physical processing should be handled only in properly designed facilities (as described in Section 3.3 above) and with proper procedures to avoid the likelihood of transfer of radioactive material to the air or to surfaces where subsequent inhalation or ingestion of the material by personnel is possible.

Where necessary to ensure that exposures are ALARA, preliminary tests of procedures should be carried out with simulated nc radioactive materials or colored liquids to check provisions for containment, handling, and ventilation. The Radiation Safety Office staff may make pre-liminary job exposure commitments using tracer levels of radioactive material in the preliminary tests.

Trays and absorbent materials should be used to catch and limit the spread of radioactive contamination whenever there is a possibility that planned procedures will fail to contain the radioactive material.

Protective clothing appropriate to the type and quantity of radioactive material being processed should be worn whenever escape of radioactive contamination is possible.

3.4.1.4 Proper Work Habits In general, all persons handling radioactive materials should be trained to be aware of the importance of using available shielding materials, maintaining as much distance as possible from radiation sources within the reasonable limits of efficient operation, and minimizing the time of exposure to radiation sources to only the time necessary to carry out the required task or clinical procedure.

The following good work habits are particularly important in ensuring ALARA exposures:

1. Sealed or unsealed sources should never be touched or held with the fingers, but only with tongs or tweezers appropriate to the operation. Adequate training in the use of proper tongs or forceps should precede manipulations with the actual radioactive material to be used.

Syringes shielded or made of high-density glass should be used when possible for injecting radio-pharmaceuticals into patients.

2. Finger badges as well as body badges should be worn by personnel who are handling or manipulating unsealed or unshielded sources with tongs or forceps or who are holding partially shielded sources or containers of radioactive material with their hands.

3. When working with unencapsulated radioactive materials, personnel should wear rubber gloves and other special clothing to protect against contamination of their persons or' regular street clothing. Recommendations of References 25, 21, and 30 should be followed in regard to the appropriate types of protective clothing for various types and levels of radioactive material.

4. Care should be taken to avoid contamination of objects such as telephones, light switches, taps, or doorknobs. When items other than those normally contaminated must be touched during a given procedure, some uncontaminated and easily disposed of material such as paper or plastic should be interposed between a contaminated protective glove and the object to be maintained free of contamination. When working within a hood containing a sink designated for radioactive washings, contaminated gloves should be washed before they are taken from the hood if possible, taken off, and discarded. Gloves should be removed in a manner that avoids the spread of glove contamination to hands or other clean surfaces.

5. Radioactive solutions should never be pipetted by mouth. Various pipetting devices are available. Even a long rubber tube connected to the pipette does not,make pipetting by .

mouth acceptable. I

6. Special precautions should be taken to avoid the possibility of entry of small amounts of radioactive material-into cuts.

7. Eating, smoking, drinking, and application of cosmetics should be prohibited in .

laboratories where radioactive materials are handled.

8. The use of containers or glassware with sharp edges shceld be avoided. Care should be taken in working with contaminated animals to avoid bites or scratches.

9. Food and drink should not be stored in the same place (e.g., refrigerator) with radio-active materials.

. 3-14

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3.4.1.5 Radiation or Radioactivity Monitoring

f. The independent radiation surveys, inspections, inventories, and smear tests carried out by the Radiation Safety Office staff, and the importance of centralized records of these activities, were discussed in Section 3.2. In addition, each user of radioactive materials should survey radiation and radioactivity levels within his own operations to help maintain exposures ALARA.

A simple logbook of daily readings maintained by the user in specified areas will help the user maintain an awareness of any changes in radiation or radioactivity levels that may indicate a need for. changes in procedures to meet ALARA radiation exposure objectives, in hospital situations where the higher exposure rates occur (e.g., in teletherapy rooms where the limits of 10 CFR Part 20 could be approached before an indication was provided by

l. means of ordinary personnel monitoring devices), self-reading devices that are read at least I

daily and warning devices worn on the body are helpful in maintaining exposures ALARA as well as within the permissible limits. Further, personnel monitoring should also be provided to employees I

at levels well below those required by 10 CFR 20 I 20.202, when such monitoring will further awareness of measurable exposures and reduce them to ALARA.

l 3.4.1.6 _ Training l' Training should be given to any employee who works in er frequents the vicinity of a restricted

) a rea. The regulations in 10 CFR Part 19, 5.19.12 require such training. In medical institutions.

l

' training sessions with all persons handling licensed materials are necessary on at least an annual basis. They should include instructions regarding the ALARA exposure philosophy as well as specific instructions pertirant to the procedures to be conducted. New employees should receive appropriate training before they are assigned work in restricted areas.

Employees should be made aware of the ALARA provisions of 10 CFR Part 20, i 20.1 as well as those of Regulatory Guide 8.10. Employees should also be instructed in the philosophy and l provisions of Regulatory Guide 8.13. " Instructions Concerning Prenatal Radiation Exposure "

(Ref. 36) whenever there is a possibility that pregnant women may be exposed to radiation.

Each employee should be acquainted with the institution's own procedures for handling radioactive sources and radioactive materials and with NRC licenses and their radiation safety provisions (including license conditions incorporated from license applications and correspond-ence). Copies of these procedures, licenses, and related correspondence should be made available  ;

to the employees as part of their orientation to radiation safety requirements. '

In ordcr to place all of these procedures and requirements in proper perspective for the employee, it is preferable that instruction on these matters be presented by a member of the radiation of radiation safety staff with protection appropriate background and experience in the science and philosophy standards. An example of a handout sheet that may accompany briefings of the nursing staff is presented in Appendix D, pages D-1 through D-4. Similar handouts may be designed for other hospital employees.

3.4.2 RADIATION THERAPY This section summarizes recommendations for maintaining exposures ALARA in three subdivisions of radiation therapy.

1. Teletherapy--the treatment of patients with high-energy beams from shielded irradiators containing sources of high gamma-ray emission rate.

2. Brachytherapy--the treatment of patients by insertion of sealed sources such as needles or tubes for interstitial or intracavitary irradiation.

3. Radiopharmaceutical therapy--the injection or oral administration of solutions or colloids of radioactive pharmaceuticals that tend to concentrate in and irradiate the organs in which they are dispersed or absorbed. l

( 3.4.2.1 Teletherapy, t

Primary reliance for radiation protection in teletherapy is based on the adequacy of facilities and equipment, since very intense radiation levels are generated.

Basic operating principles for maintaining occupational exposures ALARA can be summarized as fo,1 lows:

I i

3-15 f

q l

1. With the aid of the maintenance and operating manuals provided by the manufacturer of the teletherapy unit, procedures should be established for routine maintenance of the teletherapy unit by hospital maintenance personnel under the surveillance of the radiation safety staff.

This maintenance should ensure that all safety-related devices remain functional and that the machine generally remains safe for both patient and operator.

However, reference should be made to the institution's license regarding specific maintenance requirements; a standard condition on NRC teletherapy licenses requires that "any maintenance or repair operation on a teletherapy unit involving work on the source drawer, the shutter, or other mechanism that could expose the source, reduce the shielding around the source, or compromise the safety of the unit and result in increased radiation levels" must be performed by persons specifically authorized by the Commission or an Agreement State to perform such services.

2.

A daily morning checkuut procedure should be posted and establisned for the therapy technologist to carry out simple operation checks of indicator lights, caution lights and signs, key and door interlocks, gamna radiation level indicators, and timer operation and interlock function. These checks can be made within a few minutes of startup of the teletherapy unit and before use on patients. They serve to maintain an awareness of these warning and interlock devices by the technologist in addition to ensuring their proper operation.

3. A general safety check, including a spot or point calibration check and a check of beam alignment and confining devices, should be made and recorded at least monthly by the RSO or his staff. All records of the monthly calibration and safety check, as well as the daily morning checkouts, should be signed and dated by the persons carrying out the tests. Other checks should be conducted as recommended in ANSI standards (Refs. 27 and 28).

4 During patient treatment or operation of the teletherapy unit for calibration or maintenance procedures, care should be taken to follow written instructions and use installed safety devices to ensure that no personnel except the patient or phantom to be exposed is in the teletherapy treatment room during the " Beam On" condition.

5. During " Beam On" operation, the operator at the console should remain in a position of lowest radiation intensity consistent with vigilance of the console and patient during treatment, as advised by the Radiation Safety Of fice staff using the post-installation radiation survey.

All persons not required to remain near the console should remain or work in areas of lower radiation background intensity while the teletherapy unit is in operation. The console area L-should not be used for routine office work by persons not required for the operation of the teletherapy unit.

6. Emergency procedures established under NRC license conditions should be tested by regular familiarization sessions or by staging mock emergencies for the training of personnel.

Staff personnel supervising the teletherapy operation should be prepared to carry out emergency procedures and repairs with minimal radiation exposure (usually less than 10 mR). <

3.4.2.2 Brachytherapy Detailed reconmendations for reducing radiation exposures in brachytherapy are given in NCRP Reports No. 40 and 48 (Refs. 24 and 58). Additional reconmendations pertincnt to brachy-therapy, as well as radiopharmaceutic,. therapy, are contained in NCRP Report No. 37 (Ref. 25).

The most important practices for maintaining exposures ALARA in brachytherapy may be summarized I as follows:

1. Modern after-loading devices should be used wherever medically acceptable. Much of the occupational exposure in brachytherapy is received by the nursing and radiology staff while brachytherapy sources are in the patient. However, censiderable exposure may also be received in the operating and recovery rooms, in diagnostic radiology, and while transporting a patient to his room when intracavitary devices are inserted in the operating room. The latest medical literature and manufacturers' information may be consulted for available types of after-loading devices.

2. Jigs should be prepared so that sources may be easily loaded into af ter-loading devices- -eady for the physician's use in the patient's room. The jigs and setups should be tested by manipulating the loading of nonradioactive tubes simulating the brachytherapy sources.

3. The jigs for loading the after-loaders should be set up behind shields with lead glass viewing windows.

Auxiliary lead brick shielding should be provided to shield the arms of the personnel loading the af ter-loaders for as much of the duration of the procedure as possible.

3-16

4. When after-loading sleeves or ovoids are loaded, they should be place'l in adequately i.'

shielded carts for liquid sterilization and for transport to the patient's room when the physician is ready to insert the after-loaders, These carts should be properly tagged and should at all times be under the direct supervision of the radiation physicist or radiation safety' staff.

j- 5. Similar protect. ion should be provided for use in threading radioactive rieedles ior '

implant therapy.

! 6. While manipulating sources," loading the af ter-loaders, and threading needles, per-

! sonnel should be provided with tongs and surgical clamps-to' maintain the distance of the-

fingers preferably about 30 centimeters or more from these sources. Data for estimating hand .

exposures may be found in Reference 25, page.10. Thicknesses of lead for providing additional shielding may be found in Reference 25, pages 41-44. ,

7. Finger dosimeters as well as body dosimeters should be worn by personnel when they are loading or preparing sources for insertion. Also, the Radiation Safety Office staff should periodically survey the loading procedures and provide job-time-exposure information to help employees keep exposures ALARA. Use of a ganma-alarm type of ionization chamber stationed in the storage-loading area will indicate when radiation sources are outside of their shields and help avoid inadvertent exposure due to lost or misplaced sources.

8. A continuing list of removals and returns of individual sources from the storage containers should be maintained to help ensure against inadvertent loss and exposure of sources.

9. Sources maintained in a fixed position for a constancy check on the operation of any intracavitary ion chambers should be kept within shielded wells in constant geometry so they can be used for a rapid and safe check of ion chamber operation before the treatment of each patient.

I

10. Time and exposure studies should be carried out by the radiation protection staff on typical surgical implants and typical insertions of radioactive sources either in the operating room or by af ter-loading in the patient's room. The studies can be carried out without inter-ference in the svgical or gynecological procedures by using survey meter readings at a distance from the patient and where possible by the wearing of special finger dosimeters by the operating physician. Estimates of radiation exposure by the attending nursing staff should also be made, and results should be permanently recorded in the Radiation Safety Office files. Personnel involved should be informed of the results and of any reconwendations for further reducing exposures.

11. Transport of a patient containing radioactive material to areas outside of the operating room and to his or her room should be directly supervised by the Radiation Safety Office staff or the radiation physicist. The radiation safety or radiation physics staff should also check and supervise the transport of after-loading sources and supplies for insertion of applicators,- lead bedside shields for nurses, and any other supplies and equipment required for expediting an ef ficient af ter-loading procedure. Radiation survcvs of these procedures should be carried out on a sample basis and recorded to maintain an awareness of radiation exposures '

resulting from the procedures.

12. Some of the major reconnendations of NCRP Report No. 37 (Ref. 25) that will help keep exposures ALARA in the patient's room and nearby areas and nursing stations are:

a. It is desirable to conduct a preliminary background survey or maintain an awareness of background radiation levels in the patient's room or surrounding areas.

b. Before the radiation-emitting patient or the af ter-loaders with radiation sources ere brought to a patient's room, the nursing staff should be briefed, the patient's chart should be tagged with a radiation symbol and sign, the bed and door tags should be in place, and any portable lead shields for protection of the nursing or housekeeping staff should be availablo.

Radiation tags and caution signs should give the patient's exposure rate at one meter, the type and quantity of radioactive material, and the telephone number of the person to be contacted in emergencies.

c. The lead cart in which af ter-loading sources are transported, or which will receive interstitial or intracavitary sources af ter they are removed, should be lef t in a corner of the patient's room. The nursing staff should be instructed (1) To use tongs to place in this cart any sources that are accidentally removed from the implant or applicator during treatment, 3-17 i

(2) To contact the RSO or the physician in charge of the patient if a loose source is found, and (3) .To record the time at which the source was estimated to have been removed from the treatment volume. Patients should be instructed to guard against inadvertent removal of any sources from the' treatment volume and to immediately notify the head nurse in the event of such removal.

d. As far as possible, insertion of radiation sources should be carried out with at least partial body protection from the movable bedside shield and with sufficient assistance to the physician so that physician and staff exposures are minimized. Normally, insertion of af ter-loaders should result in less than 100 mR exposure to the physician's hand (per patient) and less than 10 mR exposure to the physician's body. Attending personnel should ordinarily receive less than 20% of the exposures received by the physician.

e. During the patient treatment period, nursing and other hospital staff should -

~

minimize time spent in the room and near the patient, consistent with the provision of all necessary care. It should be possible to provide necessary care without any nurse or attendee receiving more than 10 mR per shif t to any part of the body if the nursing staff is adequately briefed. Generally, the nursing staff should maintain a distance of more than 1 meter from the center of the volume of radiation sources in the patient. The nursing staff, together with the housekeeping staff, should also be able to provide patient care in less than a fraction of an "

hour per person per shift.

Visitors and special duty nurses should be seated as far from the patient as possible. Usually a distance of more than 3 meters is adequate, with the additional use of a lead bedside shield to reduce direct exposure where possible.

Visitors and private duty nurses should also be briefed on the concepts related to keeping exposures ALARA. The amount of time that should be permitted for each visitor depends on the type and quantity of radioactive material in the patient, as well as the degree of shielding afforded and the arrangement of the patient's room.

Recommended limits of exposure for visitors, nursing staff, emplo  ;

in other rooms are presented in NCRP Reports Numbers 37 and 40 (Refs. 24 and 25)yees, .

and patients These limits should be established by the radiation safety or radiation physics staff. The limits for each patient's room should be recorded on the patient's door and given to the nursing supervisor and entered in the patient's chart.  :

l

f. Members of the regular nursing staff who are likely to receive the larger expo-sures and any nurses likely to receive more than 25 percent of the permissible quarterly limits I of 10 CFR Part 20, a 20.101(a) should wear personnel monitoring devices. These devices should I be returned to the Radiation Safety Of fice at the end of the regular wearing period. Private I duty nurses attending inpatients who have been administered radioactive materials for either diagr.ostic or therapeutic purposes should be provided with personnel monitoring devices that are )

collected or returned at the end of the patient's treatment. In general, current reports recommend that it is preferable to limit exposure of pregnant women or fertile women who may become pregnant.

This may require a special ef fort in regard to staff attending patients undergoing brachytherapy ,

(Refs. 8, 24, and 25). Refer to Regulatory Guide 8.13 for the NRC staff position on this subject l (Ref. 36). I

g. When a treatment is completed, a member of the radiation safety or radiation physics staff should:  !

i (1) Assist in a survey for removal of all radiation sources from the patient.

4 (2) Remove the cart containing the sources from the room.

(3) Assist the physician in recording the details of the procedures in radiatica I

(4) Remove all radiation signs and libels. l (5) Carry out a final radiation safety survey of he room.

(6) Assure the patient, the nursing stcff, and any visitors that no further )

radiation exposure from these sources will be incurred. '

l l

3-18 i

I l

(7). Ensure that all_ radiation sources and associated supplies are returned to I the source storage area, cleaned, inventoried, and replaced in their secured positions in the l shielded q uit.

I (8).- Record radiation survey information and certify source return.

The above recommendations should be supplemented by the considerations presented in the references cited, as well as by any licensing conditions or applicable regulations. I I

3.4.2.3 Radiopharmaceutical Therapy (Nuclear Medicine Therapy with Unsealed Radioactive j

. . Eterials)

Preparation of the basic radiopharmaceutical dosage forms for therapy should be carried out ,

only in nuclear medicine departments that are staffed and equipped for this function. Institu- l l

tions that desire to establish their own facilities for compounding and preparing radiopharma- l ceutical dosage forms should employ a professional radiopharmacist to plan such activities and 7

assist in the design of separate laboratory facilities for these activities (Ref. 8, pp. 65-66).

(Food and Drug Administration requirements for the pharmaceutical quality and efficacy of these  ;

preparations should be consulted in addition to NRC radiation safety requirements.) The physico-I chemical processing of radiophermaceuticals that involve higher activity levels of more radio-toxic materials than the ordinary nuclear medicine diagnostic procedures will require special

[

' facilities and procedures for safe handling (Ref.16). The adequacy of such materials and facilities for radiopharmaceutical preparation in medical institutions will be judged, for NRC-licensed materials, by the Radioisotopes Licensing Branch according to requirements similar tc those for radiopharmaceutical manufacturers.

! Where feasible and in the best interests of the patient, oral or intravenous administration of millicurie quantities of the types of radioactive drugs used for therapy of specific diseases should be carried out in a specific area or a room separate from other nuclear medicine or radiotherapy Nerations. A separate small room removed from areas occupied by personnel not 3

associated with the administration of radioactive materials will help to minimize exposure to other personnel and reduce the risk cf contaminating other areas and sensitive equipment used for other radiological or nuclear medicine procedures. However, this special area or room should be in the general vicinity of the laboratory where the radiopharmaceuticals are stored to alleviate the need for transporting these materials over long distances through other arcas of the institution.

When the radioactive materials must be transported to a patient's room for administration, a member of the radiation safety staff should monitor and assist in the preparation of the materials and supplies for administration, the transport of these materials to the patient's room, and the administration of the radioactive drugs.

Unsealed radioactive materials that are administered for radiotherapy may be obtained in final dosage form and may require only a calibration check of the material using a dose cali-brator or other appropriate instrument. Vials containing 1-131 in liquid form for oral use should be opened only in a properly ventilated fume hood to avoid inhalation of free iodine that may be released. During preparation and administration of an already-prepared drug, the general principles of safe work practices given in Section 3.4.1 (including the use of drip trays, absorbent paper, tongs for handling the radioactive drug containers, bottle shields, and gloves and protective clothing), along with monitoring assistance by a member of the radiation safety staff, will be important in helping to achieve ALARA exposures. A member of the radiation i

safety staf f may also scan the patient with a portable radiation detector of small dimension and good spatial resolution, as well as a wide intensity response range, to help ensure that a satisfactory administration of the radioactive drug has been accomplished. This procedure will also help to minimi:e the possibility of the patient's contaminating hospital rooms and facilities. l l

In supervising the administration of radiopharmaceuticals to patients, the physician in j

charge and the radiation safety staff may use many of the principles given for brachytherapy in Section 3.4.2.2 above, as well as the principles of Section 3.4.1, Many of these principles are presented in more detail in NCRP Report 37 (Ref. 25), which is particularly helpful as a refer- j ence of acceptable radiation safety practices in the therapeutic administration of unsealed

! radionuclides. The use of NCRP Report- 37 in planning procedures for the administration of i therapeutic radiopharmaceuticals will help to ensure that exposures are ALARA not only during i the administration of the dosage to the patient, but also during any hospital care of the patient, during and af ter discharge of the patient, and in the event of any later surgery, autopsy, or burial of the patient.

During the administration of a therapeutic radiopharmaceutical to a patient and the subse-quent hospital care of inpatients, all of the principles given for brachytherapy in Section 3.4.2.2--

regarding surveillance of the administration in the patient's room, tagging of the patient's chart and room ' instructions to hospital staff and visitors, and provisions for emergency 3-19 ix

notification--are also applicable to the patient receiving millicurie quantities of radioactive drugs. The following additional precautions are also particularly important in achieving ALARA exposures in the case of unsealed therapeutic radiopharmaceuticals (Ref. 25).

l. Control of Contamination in the Patient's Room. Patients hospitalized for radio-pharmaceutTcaT therapy should be pl5dTn separate prTvate rooms with enough space for the hospital staff to attend the patient while maintaining a reasonable distance from the patient and from radioactive waste stored in the room.

Contamination control should include the following procedures:

a. Cover floors, furniture, and other surfaces likely to be contaminated by the patient, using absorbent paper backed by waterproof material, with the waterproofed side against the surface to be protected.

b. Protect the bed mattress with a waterproof covering and items likely to be touched by the patient with thin plastic bags.

c. Use plastic bags to protect telephone receivers from contamination.

d. Cover door handles and other items frequently touched by the patient.

e. Instruct attending personnel to prevent the tracking of radioactive contamination outside the patient's room. Where there is a serious likelihood of spreading such contamination, booties or shoe covers, put on and removed at the entrance, should be used to avoid contaminating hallways and other areas outside the patient's room,

f. Use disposable dishes and cups.

2. Collection and Removal of Radioactive Contamination in Patient Excreta. Provisions should be made either to Ta) completely collect, with the assistance of the patient where possible, any saliva, vomitus, or urine or other excreta in a manner that will contain the radioactive material temporarily until picked up by the radiation safety staff or (b) dispose of these materials in designated toilet facilities, preferably adjacent to the patient's room.

To ensure proper practices, the radiation safety staf f should see that an adequate supply of waterproof containers is available at the bedside and that widemouth plastic bottis with sealable lids are available to the ambulatory patient in the toilet area.

An adequate supply of plastic bags should also be available. These bags should bc large enough that they can be tied and the radioactive materials can be held by the bag at d distance of at least 6 inches from the hand or body when picked up for disposal.

When the rate of excretion of the radioactive material is of interest in the medical treatment of the patient, samples taken over given periods of time should be transported under the supervision of the radiation safety staff to radiochemical hoods or properly ventilated areas, where aliquots or measurements of radioactivity may be taken using general laboratory practices for maintaining exposures ALARA, as summarized in Section 3.4.1 above.

3. Collection of Radioactive Wastes. The coverings and plastic bags used for contamina-tion controllilTT generate a large vTlume of radioactive waste, generally of low contamination level. A large plastic trash or garbage can with lid, placed in a corner of the room opposite the entry, will allow temporary storage of these low-level wastes. The wastes should be monitored by the radiation safety staff daily and removed to the radioactive waste storage area.

Bed sheets and linens that come into contact with the patient should be temporarily stored in separate containers for daily monitoring by the radiation safety staff. The radiation safety staff should check these linens for the possibility of significant external radiation levels or potential for the spread of contamination, before sorting and checking them further to determine whether (a) they may be laundered with ordinary hospital laundry, (b) they should be temporarily stored for decay, or (c) they should be permanently discarded with the radioactive wastes.

A radiation safety staff member should control all procedures for collection and disposal of radioactive wastes, laundry, and decontamination procedures since a familiarity with exposure limits, good radiation safety practices, and radiation safety evaluation is necessary for achieving exposures that are ALARA during these procedures. Radioactive wastes removeri from the room should be transported as rapidly and directly as possible by cart to the radioactive 3-20

' waste s torage area. These procedures should also be monitored and estimates of radiation expo-( sures to personnel should be carried out and written in the Radiation Safety Office record.

The radiation safety staff should re-survey the patient's room as necessary af ter each decontamination procedure to ensure that hospital regula'. ions and license conditions are met regarding exposure and contamination limits in unrestricted areas.

4. Storage _ f or_ Decay _ or Disposal . Radioactive waste in sealed bags or bottles should be separated for decay or disposaTTn the waste storage area by radiation safety personnel, and the bags of waste to be disposed of with the radioactive wast: shipments should insnediately be placed in the radioactive waste drums.

t To save waste disposal costs, as well as keep exposure to the public ALARA, a shielded f area should be provided in a corner of the radioactive waste storage area to allow for decay of radioactive contaminants that have a half-life of less than 10 days. Allowing for decay of these wastes to undetectable levels will reduce radioactive waste disposal costs considerably.

4 However, the wastes should be stored adequately so that personnel entering the waste storage area to deposit other radioactive wastes will not be exposed to the sometimes higher-level wastes stored for decay.

5. Advice to patient and Staf f at Discharge. The radiation safety staff should survey the patientVrohiiFiiivWdTitWy~5Ffore the patTeht s discharge and should monitor final removal of waste and contamination before any other room cleanup by hospital s'af f. During this final radiation safety staf f visit with the patient, ALARA exposure philosophy sho 1d be explained to the patient in a straightforward, simple, and non-alarming way. These discussions may be carried out by the physician attending the patient in some institutions, but in any case the R50 and staff should be consulted.

6. patient Identification. The patient should receive a wristband, and tags should be attached to the patient's chart and bed to provide information as recon, ended in NCRp Report 37 (lef. 25, p. 9). This information includes:

a. The radionuclide administered and the activity in millicurie, at time of administration;

b. Tl- 'posure rate at 1 meter, the 'me of measurement, and the person who per-formed the measurement; and

c. The date when precautions cease to be required and when the tag may be removed--

i .e. , the date when the maximum integrated exposure to any other individual would not exceed 0.5R in one year.

/. Final Room Survey, Removal of Tags _, and Records. After discharge of the patient and final decohtiihinFon aFchanup procedures, TTrnal room survey should be carried out by the radiation safety staf f to ensure that radution and contamination levels meet regulatory require-ments. At this time, af ter the room is approved for release for normal use, all radiation caution signs and tags should be removed by the radiation safety staff, and the ta? Nuld be removed f rom the patient's chart. A record of the results of all surveys and reconaendations f or any improved procedures for reducing radiation exposures should be kept in the Ladiation Safety Office.

8. personnel Monitoring and Bioay v rvaluation. Any temporary dosimeters provided for

- personnel isnTtiring should be evaluated and the results recorded by the radiation safety staf f.

Routinely wora personnel monitoring devices should be collected at appropriate intervals, and exposure reports should be reviewed by the radiation safety staff to ascertain that regulatory requirements were met and exposures were ALARA.

The need for bioassay sampling of some of the personnel involved in administration of the radiopharmaceuticals or care of the patient should be evaluated by the radiation safety staff according to the type of radioactive pharmaceutical (Ref. 32) and the potential (Ref.16) f or appreciable inhalation or ingestion by personnel. For many of the radionuclides used in these procedures, the possibility of significant internal exposure can be checked in in-vivo counting of the lung, thyroid, or other organs appropriate to the radiopharmaceutical administered, using the ordinary nuclear medicine scanning or camera equipment. If many 1-131 therapy cases are treated in the same location over a short period of time, the R50 may consider air sampling evaluations and thyroid checks of the nursing staf f, 3-21

Professional health physics consultation will be needed to determine with the assist-ance of the nuclear medicine staff the appropriate methods of bioassay and evaluation of potential internal radiation exposure of personnel. The latest edition of Reference 38 will provide summary data on some of the nuclides and dosage forms used on patients. These data may be useful intake.in determining possible exposure to personnel with allowance for the different modes of References 33 and 38-46 also provide data that may be useful in converting dose infor-mation in References 32 and 33 into exposure evaluations of personnel in various exposure situations.

There are also important radiation protection considerations presented in NCRp Report Numbe.- 37 for protecting medical, nursing, or undertaker personnel during surgery, autopsy, embalming, or burial of patients who have been administered radioactive pharmaceuticals (Ref. 25).

Procedures should be established to ensure that wristbands are provided to patients or other means are made postmontem available to readily identify any radioactive patients undergoing surgery or procedures.

Even af ter discharge from the hospital, most patients will still have consisting tissue. of such short-lived isotopes as radon-222, contained within a confined volu high as 10 rads per hour or more.Within these irradiated tissue volumes, remaining dose rates at close range can be a monitored by a member of the radiation safety staff, or very specific procedures should beThus, the established for radiation protection.

In surgical or autopsy cases, the tissue volume containing all the radioactivity may be removable; when this is the case, this tissue volume should be removed and placed in a safe container and location before further surgical or autopsy procedures are carried out. When the surgeon or pathologist must operate on a radioactive patient or cadaver, the hands should generally be maintained at a distance of five centimeters from tissues containing radioactive material to avoid beta-ray dose-rates. For patients containing unsealed radioactive materials, blood and other tissues discarded from the operation should be treated as radioactive waste. These wastes should be held for decay before disposal, when practicable--particularly for nuclides having half-lives of less than 10 days.

Patients who have received therapeutic radiopharmaceuticals should also be monitored prior to discharge to ensure that their remaining radioactivity is below license requirements (see also the NCRP recommendations, Reference 26). NRC license conditions prohibit the discharge of patients containing greator than 30 mci of I-131 or Au-198, Also, before any radioactive cadavers are turned over to undertakers, the radiation safety staff should be called to obtain a radiation survey and recommendations for ALARA procedures to be carried out by the undertakers. Where the undertaker staff could possibly be exposed to levels that might exceed 25% of the limits of 10 CFR part 20 for persons in unrestricted areas, consideration should be given to providing assistance or advice to the undertaker regarding personnel monitoring, in carrying out all of these procedures for the protection of the medical staff and employees, consideration should be given to the proper briefing of family or f riends who may be concerned if they are made aware of the radioactive nature of the patient or the deceased. Proper planning and coordination between the radiation safety and medical staff will ensure that family and friends will not be unduly alarmed as a result of radiation protection procedures.

3.4.3 DIAGNOSTIC NUCLEAR MEDICINE A summary of some of the more important considerations in maintaining occupational expo-sures ALARA in diagnostic nuclear medicine is given below:

1.

Radionuclide Generators. These should be set up in an area separate from other nuclear meificine operations, with adequate ventilation and additional shielding as necessary to reduce external as well as internal exposure to personnel during elution. An auxiliary generator shield should be provided for molybdenum-99, technetium-99m generators as delivered from radio-pharmaceutical companies, since the shielding of these generators when delivered is not neces-sarily designed to be adequate to protect nuclear medicine personnel af ter the generator is removed from the shipping carton.

2.

Assay of Tc-99m. Af ter elution of a batch of Tc-99m an appropriate sample should be placed in a separate shTelded bottle for checking the assay of the eluate in the nuclear medicine dose calibrator or other suitable assay system. This procedure permits calibration with a smaller quantity of radioactive material. All patient doses should be assayed prior to administration.

3.

Use of Fume Hoods. The use of fume hoods and good contamination control principles

~

when preparing dosages of radiopharmaceuticals that have potential volatility will help to ensure ALARA internal exposures of personnel.

3-22

4. Maximum use of syrinee shields during administration of dosages can be a major factor in maintaining exposures ALARA (Refs.13 and 15). This may require special training. Unshielded bottles should never be touched or carried directly with the fingers. Syringe shields should be routinely used for preparation and administration of patient doses, except in circumstances where their use would compromise the patient's well-being. Tongs should be red when bottles must be removed from shields or to hold unshielded syringes containing radioactive material for transfer during dose preparation.

5. Storage of Vials. Unshiel led vials should never be stored behind bench shields that are routinely used for manipulating ladiopharmaceuticals. Vials of radiopharmaceuticals not in use should be ininediately placed back in their shielded lead containers and stored in a shielded section of the laboratory that is properly labeled, as required by 10 CFR Part 20, 6 20.203.

6. Dosimeters and Badges. Finger dosimeters as well as body badges should be worn by all

~

nuclear medicine personneTisho will prepare and administer radiopharmaceuticals, and records should be kept in the Radiation Safety Of fiwe of the cumulative exposure during each calendar I

year of each monitored employee's finger exposures. as well as the cumulative whole-body expo-sure as evaluated from the whole-body badge. In nuclear medicine 0, erations where lead aprons are worn to protect against technetium-99m, gansna exposure (which can be used as an additional p

means of keeping exposures ALARA if such aprons do not interfere with medical procedures), the whole-body badge should be worn outside the ap-on in order to monitor parts of the body that have the same exposure limits as the whole body according to 10 CFR Part 20.

7. Waste. Shielded radioactive waste cans containing used syringes and other radioactive wastes shoUld 6'e kept at an adequate distance from the laboratory areas most frequently occupied by personnel, while still remaining convenient for use and rapid disposal of radioactive wastes, since sometimes gamma emitters with the more penetrating photon emitters may build up temporarily higher external radiation levels in the laboratory.

Radioactive wastes placed in these cans shoJld be contained in plastic bags that are large enough and strong enough that they will not break when the waste is ultimately discarded into the waste drums in the radioactive waste area. All syringes, needles, and pipettes (including pasteur-type) should be appropriately capped to prevent puncture of the radioactive waste bags in the waste containers and to prevent internal contamination to nuclear medicine personnel handling the waste.

Radioactive waste cans should be emptied of ten enough that unnecessary occupational exposure will not be received by nuclear medicine employees. Also, the radioactive waste cans should be emptied often enough, by transport of the shielded pail preferably on an appropriate cart to the waste disposal room, so that the inner plastic lining will not be overfilled, but may be easily closed and seled for use in safely transferring the radioactive wastes to the radioactive waste storage aisms in the storage area. It may be desirable in some busy depart-ments to have an extra radioactive waste can to prevent overflow.

8. Camera Procedures. During scanning or camera procedures, technologists should te

~

aware of the advantages oT~ keeping a reasonable dis Lance away from patients containing radio-active materials, while at the same time avoiding any impression of fear from the very low risks that are being incurred when exposures are ALARA. Where they do not interfere with the diag-nostic tests, protective lead screens can be very helpful in achieving exposures that are ALARA for procedures using Tc-99m or other low-energy garuna emitters.

9. Xenon-133, in lung perfusion or ventilation studies with xenon-133, additional lead i shielding oTl.6 nun thickness around the absorber cannister, oxygen bag, and waste receptacle can reduce occupational exposures to some degree when frequent xenon procedures are carried out. An added shield of 3.2nsn of lead interposed between the xenon dispensing-collecting apparatus and the gamma camera may help to ensure better diagnostic information, whicn may avoid the necessity for repeat procedures.

Better diagnostic information may also be achieved by keeping an adequate distance from the xenon waste absorber or waste storage bag. Inunediately af ter a procedure using xenon-133, the waste xenon should be removea for decay or disposal to a remote area to minimize exposures to external or internal irradiation from the xenon-133.

10. Contamination Control. Contamination spills during work hours that may produce appreciable occupational exposure or interference with nuclear medicine procedures should be immediately cleaned up using appropriate measures for contamination control and waste disposal as suggested in Section 3.4.1 and Section 3.4.2.3. At the end of each day, nuclear medicine departments should be monitored for external radiation levels and possible areas of contamination that should be cleanei up according to the institution's radiation safety procedures. However, 3-23

where cleanup of larger amounts of short-lived nuclides such as Tc-99m may entail additional occupational exposure, consideration should be given to containing the spill or contamination by means of absorbent covers to allow overnight decay of the contamination before early morning cleanup the next day.

All surfaces likely to be contacted by personnel such as telephones, d,or knobs, desks, handles, and instrument knobs should be periodically checked for contamination by the nuclear medicine staff, as well as by the Radiation Safety Office staff during its regular surveys.

Records of all contamination surveys should be maintained with dates and signatures,

11. Bioassay Programs. External radiation exposure evaluation ard bioassay programs judged appTTciSTe by the Tidiation Safety Officer or required by the radioisotope license will also be an important part of ALARA exposure programs in nuclear medicine. References 32-34 4.nd 38-46 give information on providing appropriate bioassay evaluations.

3.4.4 LOW-LEVEL CLINICAL OR MEDICAL RESEARCH LABORATORY ACTIVITIES Laboratories in medical institutions that use tracer amounts of the less radiotoxic nuclidas may keep exposures ALARA by using the recommendations given in Section 3.4.1 and some of the recommendations of References 10, 16, 18-19, and 22. Many of the radionuclides used for in vitro clinical tests such as blood volume, radioimmunoassay, and other low-level in vitro or animal studies involve pure beta emitters or weak gamma emitters, with only microcurie or submicrocurie quantities handled and processed by individual personnel at any one time. External and internal radiation exposures to personnel in such laboratories should ordinarily be maintained well below 10% of the permissible occupational exposure limits of 10 CFR Part 20 through careful initial planning of laboratory facilities, equipment, and procedurcs by the laboratory supervisor in conjunction with qualified health physics personnel, using the references cited.

3.5 MANAGEMENT AUDIT AND INSPECTION OF THE RADIATION SAFETY PROGRAM Ultimate responsibility for the establishment and continuation of an adequate radiation safety program in a medical institution has been placed with the governing body of the hospital (Ref. 2; Ref. 10, p. 45). The administrator reporting to this governing body should be suffi-ciently informed at all times to be sure that all regulations are faithfully adhered to and that the use and safe handling of radioisotopes are properly carried out to achieve ALARA erpo;ure objectives.

Hospital administration may find it helpful to carry out an annual audit of the radiation safety program in cooperation with members of the Radioisotope Committee and the Radiation Safety Office. The results of this audit may then be discussed at an annual radiation safety committee meeting to ensure that all usera end responsible staf f are aware of current policies and procedures and methods for their improvement. An inspection checklist (Ref. 47) is included in Appendix E to illustrate items that may be inspected by the administration during this annual audit in order to (1) ensure that regulatory requirements and license conditions are being met and (2) obtain a current familiarity with the overall effectiveness of the radiation safety program of the medical institution and possible ways of improving radiation safety practices. A report of the results of the audit should be maintained by the Radiation Safety Office for possible use in expediting any inspections by regulatory or accrediting agencies.

3-24

APPENDIX A I AGREEMENT STATES

(As of April 5, 1977) 1 Alabama 205-832-5992 Idaho 208-384-3335 Mr. Aubrey Godwin, Director Mr. Michael Christie, Supervisor Division of Radiological Health Radiation Control Section

Environmental Health Adminis. Idaho Department of Health

! Room 314, State Office Building and Welfare L Montgomery, Alabama 36130 Statehouse Boise, Idaho 83720 Arizona 602-271-4845 Ka nsas 913-296-3821

} Mr. Donald C. Gilbert. Exec. Dir.

l Arizona Atomic Energy Commission Mr. Gerald W. Allen Director First Floor - Coninerce Building Bureau of Radiation Control l 1601 West Jefferson Street Division of Environment Phoenix, Arizona 85007 Dept. of Health & Environment Building 740 Arkansas 501-661-2307 Forbes Field Topeka, Kansas 66620 l Mr. David D. Snellings, Jr., Director

! Div. of Radiological Health Kentucky 502-564-3700 Arkansas Department of Health 4815 West Markham Mr. Charles M. Hardin, Manager Little Rock, Arkansas 72201 Radiation Control Branch Bureau for Health Services California 916-445-0931-Lic. Insp. Dept for Human Resources 275 East Main Street Mr. Joe Ward, Chief - 916-322-2073 Frankfort, Kentucky 40601 Radiologic Health Section Department of Health Louisiana 504-389-5963 714 P Street Rm. 498 Sacramento, California 95814 Mr. B. Jim Porter, Administrator Division of Radiation Control Colorado 303-388-6111 Natural Resources and Energy Ext. 246/247 Dept. of Conservation P.O. Box 14690 Mr. Albert J. Hazle, Director Baton Rouge, Louisiana 70808 Occupational and Radiological Health Division Maryland 301-383-2744/2735 Department of Public Health 4210 East lith Avenue Mr. Robert E. Corcoran, Chief Denver, Colorado 80220 Division of Radiation Control Dept. of Health and Mental Hygiene Florida 904-487-1004 201 W. Preston Street b Baltimore, Maryland 21201 Mr. Ulray Clark, Administrator Radiological Health Program Mississippi 601-354-6657/6670 Health Program Office Dept. of Health & Rehabilitative Service Mr. 3 die C. Fuente, Supervisor 1323 Winewood Blvd. Radiological Health Unit Tallahassee, Florida 32301 State Board of Health Jackson, Mississippi 39205 Georgia 404-894-5795 Nebraska 402-471-2168 Mr. Richard H. Fetz Director Radiological Health Unit Mr. Ellis Simmons, Director Department of Human Resources Division of Radiological Health 47 Trinity Avenue State Department of Health Atlanta, Georgia 30334 301 Centennial Mall South P.O. Box 05007 Lincoln, Nebraska 08509 A-1

Nevada 702-885-4750 South Carolina 803-758-5548 Mr. William C. Horton, Supervisor Mr. Heyward Shealy, Chief Division of Health Bureau of Radiological Health Dept. of Human Resources State Department of Health and Carson City, Nevada 8971.0 Environmental Control J. Marion Sims Building New Hampshire 603-271-2281 2600 Bull Street Columbia, South Carolina 29201 Mr. John R. Stanton, Director Radiation Control Agency Tennessee 615-741-7812 Division of Public Health Services State Department of Hecith & Welfare Mr. Robert H. Wolle, Director State Laboratory Building Division of Occupational and Hazen Drive Radiological Health Concord, New Hampshire 03301 Department of Public Health 727 Cordell Hull State New Mexico

~ 505-827-5271 Office Building Ext. 240 Nashville, Tennessee 37219 Mr. Russell Rhoades, Chief Texas 512-458-7341 or 7686 Occupational Health & Radiation Protection Division Mr. Martin C. Wukasch, P.E., Director Environmental Improvement Agency Division of Occupational Health State of New Mexico and Radiation Control P.O. Box 2348 Texas Dept. of Health Resources Santa Fe, New Mexico 87503 Austin, Texas 78756 New York 518-474-2178 Washington 206-753-3459 Mr. T. K. DeBoer Director Mr. Robert C. Will, Supervisor Technical Development Programs Raoiation Control Unit New York State Energy Of fice Division of Health Swan St. Bldg., Core 1, 2nd Fl. State Department of Social and Empire State Plaza Health Services Albany, New York 12223 Olympia, Washington 98501 North Carolina 919-733-4283 Mr. Dayne H. Brown Head Radiation Protection Branch Division of Facility Service Box 12200 Raleigh, North Carolina 27605 North Dakota 701-224-2374 Mr. Gele A. Chris tianson, Dir.

Div. of Environmental Engineering Radiological Health Program State Department of Health 1200 Missouri Avenue Bismarck, North Dakota 58501 Orejon 503-229-5797 Dr. Marshall Parrott, D.Sc.

Radiation Control Service Division of Health Dept. of Human Resources 1400 South West fif th Avenue Portland, Oregon 97201 A-2

l APPENDIX 8 RADIATION SAFETY TASKS INVOLVED IN KEEPING OCCUPATIONAL EXPOSURES ALARA

1. Surveys of the following radioactivity areas:

a. Nuclear medicine

b. Radiation therapy

c. Oncology

d. Pathology

e. Cardiology

f. Pediatrics

g. Radioactive waste disposal and storage

h. Other research and clinical laboratories using radioactive materials

2. Surveys of diagnostic and therapeutic machines and generators, including:

a. Teletherapy sources and machines

b. Computerized axial tomography scanners

c. Interlock and safety checks

d. Calibrations

e. Fluoroscopes

f. Radiographic X-ray

3. Personnel monitoring

a. Review of personnel exposure data and reports

b. Preparation of reports required by regulations

c. Filing, collection, and mailing of personnel monitoring devices (including late and lost)

d. Special investigations of exposure and notifications to regulatory agencies where appropriate

4. Radiation safety instrument calibration and maintenance

a. Calibration

b. Battery replacement and adjustment

c. Pocket chamber and ILD calibration

d. Lightrepair(electronic)

e. Instrument selection and distribution

f. Check-source calibration

5. Decontamination and waste disposal

a. Collection and packaging

b. Surveying

c. Recording i d. Shipping arrangements

e. Placarding

f. Decontamination of surgical instruments, rooms, and laboratories

6. Leak testing radioactive sources using the following techniques:

a. Wiping

b. Counting

c. Calculations

d. Recording

e. Counter calibration B-1

7. Evaluaticr. c' internal exposure by means of:

a. Collection of sanfles

b. Radiocnemical or scintillation bicassay analysis

c. Counter calibration

d. In vivo counting

e. Chiiipit5r analysis of results

8. Special surveys of patients and rooms for implant, intracavitary, m unsealed radiopharmaceutical therapy, including:

a. Room preparation and protective covering

b. Labeling (bed, chart, door)

c. flursing staff and housekeeping staff briefings

d. Background surveys

c. Source insertion and af ter-loading surveys

f. Surveys of patients in operating room and recovery room 9 Placing of lead barriers

, t. . Rocovery of sources and Wastes

] i. Survey of room cleanup and decontamination J. Instructions to patient

9. Administration and consultation, including:

d. Ireparation of license applications and amendments

b. Pr eparation of hazard evaluation reports for licensing

c. Programming of routine required surveys

d. Supervision of routine radiation safety operations

e. Revisions to radiation safety manual

f. Periodic radiation safety instruction for hospital staff and administration 9 Training of residents and medical staff

h. Conferences with physicians and other safety staff

1. Coordination of radiation safety comittee meetings and ninute J. Inspections and discussions with government regulatory agenc /

rcpresentatives

k. Prof essional meetings 1

Selection and ordering of equipment and supplies

m. Planning and budgeting

n. Facility and shield design and meetings with architects

o. Record mainter3nce and related computer programing B-2

APPENDIX C SUtV1ARY CHECKLIS~ V RADIATION SAFETY CONSIDERATIONS IN HOSPITA ACILITY AND EQUlrMENT DESIGN

1. In larger hnspitals,1,000 square feet or more for:

a. Receipt, processing, and filing cf regulations and licensing correspondence.

l t. Preparation of survey and personnel monitoring reports / records.

c. Counting wipes from contamination surveys and leak tests.

l  ? Providing instructions and briefings to personnel.

I Calibration, maintenance, and repair of radiation safety equipment.

I Stocking supplies for labeling, surveying, decontemination, and personnel nonitoring,

g. Frccessing of orders for and receipt, inspection, end dis tribution of radio-active materials.

Stormje for sources not in use and for radioactive wastes.

i. Decontaminatlag personnel, clothing, and equipment.

2. W.::vate office space to carry out pertinent tash of Appendix B.

2  ;< Nute space in all areas where radioactive materials are used or handled so it.c personnel may maintain appropriate distances from sources when they must be i

hieldml.

AJmato floor loading capacity in areas where heavy shielding (permanent or  :

'i

';.t ar y) may be re3uired.

n,'

C

..; ate shielding and ventila tion in all aren in which radioactive m terials

.n e sed.

C. he ent shielding when needed, particularly for teletherapy.

Sm ir:3.1 that are eosily decontaminated in all areas where contamin9 tion by n a!rd radioactive materials is possible. '

E i s tien signs, symbols, caution lights, intericcts, keylnd s, ed mjepenent

-wosing alarms a t appropriate operating s ta tiers and entrancewajs.

v '_ .:rply of ex ht y a fc 5 re r. ; ' .ir.. ;- ! s< t, ,2 , y er,

Ruler r adioac t n e i, o u r '

quwh tie '- nle,. cra t m of cp ro ion.

C-1

APPENDIX D INFORMATION USEFUL FOR MAINTAINING RADIATION EXPOSURES ALARA SAMFLE RADIATION SAFETY HANDOUT INFORMATION FOR BRIEFING NURSING STAFF l

1. Definitions Roentgen (R) a unit (1 e.s.u./cc) of the amount of x or gannna radiation, measured by the amount of electric charge produced in the air near the point of measurement. (About 400 Roentgens to the whole body would be lethal to about half of those exposed.)

Milliroentgen 1/1000th of a Roentgen. Note: Averaging less than 100 milli-roentgens (mR) per week wB I~ keep you within safe limits, but you should try to keep exposures "as low as reasonably achievable" (ALARA).

Rad 100 ergs of energy absorbed per gram. This is about the rate of energy absorbed from 1 Roentgen of x or gamma rays near the surface of the body.

Rem the amount of any kind of radiation that is equivalent in biological damage to one Roentgen of x or gamma rays.

Curie an amount of radioactivity equal to 37 billion atoms disintegrating per second. It does not by itself determine the hazard unless you also know the type of radioactive material, how many gamma rays are emitted for each dis-integrating atom, etc.

Half-Life the time for the number of radioactive atoms and the radia-tion intensity to decrease by 1/2.

2. Maximum Permissible Exposure Rates:

Ordinary Employment:

(a) 5 Roentgens (R) per year (b) 5,000 milliroentgens (mR) per year (c) 100 mR per week (for 50 workweeks per year)

Pregnant Nurses:

Maximum of 500 mR during 9 months of pregnancy *

(Refer to Nuclear Regulatory Comission Regulatory Guides 8.13, which should be available through the Radiation Safety Office.)

General Principle:

No unnecessary exposure. Although exposure to naturally occurring radiation cannot be avoided (f or exampTE, the radiation dose due to nattral background may vary from 100 to 200 mR/yr depending on geographical location), all occupational exposure is considered to carry some risk, and unnecessary exposure should'be avoided. Maintain exposures ALARA, but do not fear reasonable exposures within limits. The risk is small compared to other risks of daily life when safe practices are followed (as described in the hospital radiation safety manual).

• See Reference 47 for a more detailed discussion of the advisability of limiting exposure during pregnancy.

D-1

3. Radiation Safety Precautions _ (Routinel (a) Minimize unnecessary time near patients, but provide necessary care.

(b) If possible, stay within time posted on door or on patient's chart, but provide i patient's needs. If time must be exceeded during one case, keep average exposure well within limits for all cases in a 3-month period.

(c) Stand behind lead shield as much as possible when shield is provided.

(d) Limit visitors to no more than 15 minutes, if possible, and have them sit at least 6 feet from patient.

(e) If patients have been injected or treated with radioisotopes in drug form, other than sealed sources such as radium or cesium implants, their clothing or bodies may be slightly contaminated. tiinimize contact with such patients, but provide necessary care and then wash hands af ter contact. Have Radiation Safety Office make surveys and check clothing and bed clothes before removal.

(f) Wear film badges or other oersonnel monitoring devices when provided by Radiation Safety Office for work near radioactive materials.

4. Radiation Emergencies, Incidents, or Further Information (a) If you suspect that a radioactive source may have been inadvertently removed from a patient or find a small needle or tube that you suspect may be radio-active, take long forceps (do not use fingers) and remove the unidentified object to the corner of the room farthest from personnel. Place the object in a lead shield, if one is available.

(b) Limit access to the room and call Radiation Safety Office immediately:

, Extension (1) _ Radiation Safety Assistant,(Home: )

or (2) , Extension (Home: -

)

Radiological Physicist, or (3) , Extension (Home: -

)

Chairman, Medical Isotopes Committee, or

, Extension (Home:

(4) _ Radiation Therapist, or

)

(5) , Extension (Home: -

)

Director, Nuclear Medicine Department (c) If the spread of radioactive contamination is suspected (this kind of event would be extremely unlikely). keep all persons who entered the room in a nearby hall until they can be checked by someone from the Radiation Safety Office. If this is not possible, haw persons who must leave the areas wash exposed areas and change clothing, leaving suspected clothing in plastic bags for checking. Wash hands if potentially contaminated materials were touched. Wear shoe covers or take other precautions against spreading contamination, when advised to do so by the Radiation Safety Office.

5. References To Read (a) The hospital's radiation safety handbook.

(b) " Precautions in the Management of Patients Who Have Received Therapeutic Amounts of Radionuclides," NCRP Report No. 37, National Council on Radiation Protection and Measurements (NCRP), Publication Department, P.O. Box 4867 Washington, D.C. 20008 (Oct.1,1970). (Every nurse should order a personal copy of this excellent report, read it, and keep it for reference.)

Da

(c)' " Radiation Protection for Medical and Allied Health Personnel," NCRP Report No. 48 August 1,1976 (order from NCRP, address above).

6. Hospital Routine And Nursing Care for Radioactive Patients The following pages, reprinted with the permission of NCRP, contain recommendations from NCRP Report 37 (Ref. 25) that are particularly useful in maintaining exposures ALARA by the nursing staff (reprinted by permission). The entire report should be read for further details.

l D-3

10 / 3 IJO5pITAI, ROUTINE AND NURSING CARE 35 TIIERAPEt.1 TIC PROCEDURES / 11 3.1 General Con =iderations for Nur*ing Care patients with appreciable radioactive burdens, espeerany those patients receiving therapy for gynecological cancer.

The length of tinic tlnt attendants may spend in caring for pr.tients Unless a ratient requires extensive care, one attends.nt can usually shouM be lirmted by the exposure they raay receive. Accordir. gly, as

~

perform all the routine duties m the time allowed. When there it a soon as the radionuclide has been administered and the exposure rate pomibility that an attendant may receive in excess of 2's percent of the determined, the re=ponsible person (Itadiation Prc.tection Supervisor or 3 nms permitted in a 3-month period or fraction thereof, personne3 radiotherapist) ahall attach the rahactivity labels and issue any monitoring shall be established.

special nursing instructions and limitations on visitors. A specis! duty nurse shid not be ass,gned to care for more than one i

In Table 3 ore given approximate times for expomre of 190 mR from radioactive patient per rnonth unless an exception is approved by the 100 mci of seve al radionuclides at two specified distances. These EdO" DME N "

values have been calculated from the data of Table 1, and are accord-ingly conservative. If the ad ninistered activity was roore or less than 100 mci, the times detdd be modined proportionately. 3.5 Precautions with Varioun Types of Therapeutic Procedures Decisions as to whether or not attendants caring for radioactive patients are to be c!stsified as raciiation workers are to be made by the Therapeutic proced. ires to be considered here can be divided into Radiation Protection Supervisor. To mimruize exposure of hospital per- two cla=ses: (1) treatment with encapeulated sources, permanent or sonnel,it is recommended that radioactive patients not be concr itrated removable, which are mechanically inserted; (a treatment with solu-in one area, but dispersed. However, in some large centers, where there tions, enuoidal mspensions or microephe*es.

are many such patients, dispersal may be undesirable and it may be For patients being treated with encapsulsted sources, the only radia-

? preferable to concentrat. them in deHgnated rooms or wards under care

• tion risks to attendants re! ate to exposure to radiations emitted by of specially trained personnel. This is a matter of institutional policy. the ra.lio,ctive material while in the patient or during movement of the Pregnant nurses should not be re=ponsible for the routine care of source st the timc of insertion and removal. Expo =ure may be contro!!ed by limi*ing the duration of attendance, as outhned in the fonowing see- i Tme 5-Arprorimata um, jer arposure <f too ,wnarocarya, from sco mci ej tlans.

wwo r.tio.we'ia<,, et ,pe. gi<a ars.we, In treaf ment with =olutions, colloidal suspension < or microspheres, ame.=imm na w no ms se wo mc2 ciprsure times are alco important becau<e of the exi=t ,ce Of a radia-M***** I OU At 2 6eet S et

"*")

At e F=t it SJ

1. ""4

. and, in add tinn, there is a pocSibi!ity of accidentaI ceq.

tamination of attendants by contact with the pntients or their cureta h*

• Cesium 137 nr vomitut In dealing with there paticro it is nere- ,ry to practice 1 10 Chromium 51 the " good hou<ckreping" habits recommendal for all mdividual work-25 zm in vith radioactive materials [4]. Rubber or plaetic gloves doll be ii: is wo*n wherever contamination is pocible. The gloves should k washed lone 125- 12 115 thoroughly vehile still on the hands. After rrrroval of the gloves, the t e ue-131 14 15 hands should immediately be washed thoroughly, particular attention Iri.liumE2  ?; 7 n e um er n A n* M 5 being given to the fingernails. If contamination is suspected, the Tantatumas2 M s hands shall be rnnnitored to make sure that no contamination remains.

Eating or smokin ; when there is a pomibility of hand contamination

• These values are based on the maximum values twted in Ta!4e 1. Empteure shall be prohibited, rates below these masunum valuca sul increase the amount d time necessary to areumulate 100 mR. Small disposable tissues that may be slightiy contaminated may be 6 Either of these in evihbrium with short-hved d .ughters and fdtered by 0 5 flushed down the toilet. They shM not go into the regular waste-mm pt. basket. For larger amounts of material, including contaminated linen,

l

)

12 / 3. IIOSPITAL ROUTINE AND NURSING CARE a suitable waterproof, pedal-operated waste can or disposable plastic the two days is a total of 5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br />. (These five hours are not in addition bag should be provided. These shall be turned over to the Itadiation to the half hour at 2 feet.)

Protection Supervisor for disposal. 3.5.2 Permanent Implants. Sources in this class which reprennt Specid precautions regarding the use of individual radioactive potential radiation hazards are radon, chromium-51, iodine-125, geld-nuclides wi'l be considered in pertinent sections below. 193, tantalum-IS2, and iridium-192.The radon and gold decay rapidly, 3.5.1 Remot cme Sources Used Internally. With sealul sources, there so that permissible time increases from day to day. A satisfactory is no danger of radicactive contavnination except by damage to, or loss approximation for these two nuclides is to double the permissible time of, a source. No special precautions need be taken with regard to food after three days and again at the end of the first week.

utensils, bedding, or excreta, except to M sure that no source is lost via For example, consider a patient with 40 mci of radon implanted in thee routes by accidental premature remove.L The p.obkm to be con- a nec': rsde. IIe may be ah!c to care for himscif, but food trays nnd n !cred is the arent of time the attndant simid be allowM to sncud medicines douff ix breu?t to hin. Durin;; ite f.r t 3 Gys, at a in vurias avivitia conne-ed with patient care; this depends oE the distance of 2 feet, a dese of r.hout 100 enem may be receivcd in aboat radiation exposure rates at various posit'ons. Determination of expo, an boar. IIowever,it is probable that an atten' dant need spend no more sure rates has been discussed in Section 3.2. than 5 minutes a day at this short dists ice. At a distance of 6 feet, a During interstitial and intracavitary radiotherapy, surgical bandages dose of 100 mrrm would be accumulat A m about 10 hours1.157407e-4 days <br />0.00278 hours <br />1.653439e-5 weeks <br />3.805e-6 months <br />. After 3 days, and dressings should be changed only by the physician in charge or times to accumulate 100 mrem at e ay particular distance are doubled.

another individual designated by him and trained in techniques appli. Permanent implants of beta-evaitters, such as yttrium-90, do not cable to such cases. For gynecological patients perineal care is not normally present significant bara ds.

ordinarily given during the treatment, but the perineal pad may be 3.5.3 Solutions, Colloidal Sus pensions, and Microspheres. Radio-o changed when necessary. In this case care must he taken to ensure that nuclides presently of importance k 'his category include phosphorus-32,

& radioactive sources or source containers are not disturbed or loosened. yttrium-90, iodine-131 and goldm Yttrium and phosphorus are pure If a source should get free, it shall immediately be picked up with beta-emitters and do not give rise to significant external irradiation.

forceps and placed in a container which is to be left in the patient's (The brennstrahlung is measurable, but the dose from it is insigni6-nom until the arrival of the physician or the Itadiation Protection cant.) Phosphorus-32 and gold-198 in colloidal suspension may be in- i Supervisor, both of whom shall be notified at once, jected directly into localimi malignant growths and these colloids are '

Patients who are disoriented (due to the influence of medication or also freqaently used in body cavities. Iodine-131 is generally admin-for other reasons) and are not fully aware of the nature of their treat, istered in iodide solution in treatment of thyroid diseases. IIalf the ment, may have to be restrained in enfer to prevent loss or ma! position iodine may be excreted within the first day or two. The gold is not of a source. eliminated, but its half-life is short (2.7 days). Accordingly, the ap-As an example of the radiation protection problem in intracavitary proximate rules mentioned in connection with gold and radon in sealed therapy, consider a patient with 80 mg of radium in an intrauterine sources may be used here, namely, double all tabulated times after 3 applicator, which is to remain in place for 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br />. The nurse caring days, and double them again at the end of the first week. IIowever, for such patients should be clasaiSed and instructed as a radiation if iodine is administered in che nical forms other than the iodide, the worker, with a maximum permissible dose equivalent of 100 mrem per first doubling should be after one week and the second after two weeks.

week. At a distance of 2 feet, a dose of about 100 mrem can be Certain special precautions may need to be ob*erved with iodine-131.

anticipated in about half an hour. Accordingly, during the two-day The patient who has received a therapeutic administration of iodine-treatment period, the nurse should spend less than a quarter hour each 131 may contaminate his food dishes and utensils with salivary excre-day within two feet of this patient. Making the bed and performing the tion. IIence he should have his own tablewace, kept separate for a few associated tasks, during which the attendant might be close to the days, or use disposable articles. Also in his case r large amount of the e

patient, should not take more than 10 minutes. A bed bath may be radionuelide is excreted in the urine. IIe should be permitted to use the omitted during these two days. At greater distances from the patient, regular toilet facilities, but whenever it is desirable to collect the urine longer times are permitted; e.g., at 6 feet the permiWhle time during for assay, special containers should be provided. Such a patient is usu-

14 ,

3 II(6PITAI, IMllN1 AND ht IUING RARE 3 PROTECTION OF OTill;R PATIENTS AND VISITOM / li ally ambulatyry and ahouM be instructed to coIIect his own urine. lf the If there is en appreciable amoimt of liquid, paper towels should be attendant must perform thi= duty, he should wear ru!her gloves. The gioves shouM be washed thoroughly while still on the hands Then the droptwd upon it and left until the Radiation Protection Superv,=or i arrives. If there is contamination of the patient or of or.her persons, gloves shouM be remoud nd the hands wa hed thoroughly. A separate clothing shouM be removed and stored within the marked area. Con-bedpan or urinal shosM be kept for the patient until be is discharged. taminated skin shouM be scrubbed, using a washroom in this area, or Then the bedpan or urinal should be scrubbed thoroughly with soap wash basins brought to the area for this purpose. Contaminemtion shall and water and monitored for contamination before being returned to not be removed from the area or further cleanup attempted before stock. If the patient treated with radioactive iodine vomits or is in-arrival of the Itadiation Protection Supervisor. IIowever, the following continent within the first 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> after administration of the radio- actions shouM be carried out as rapidly as possible, even before the nuclide, or if he perspires excessively, there may be contamination of arrival of the Radiation Protection Supervisor:

the bed linen or even of the floor. In any such emergency, or if the urine is spilled during collection, the Radiation Protection Supervisor shall be '* ## "

• Fu!Dmoned i!Dmediately to supervise the decatamination. Ewever* seh as P42, the immwIure concern .as only to prevert spread of enn-certain precautionary procedures shouM be mstatuted at once. (See H pmih!c, :he regi>n nf the spH1 shordd be covered with Section 34.) a p?sstic bed shm and then with the eTiivalent of M inch of soft No special precautinns regarding vomites, urine, or sputum are alerknt material such as 2 thick bbnkets. This will protect per-annnel within the treinn from radiation exposure and shotdJ be !*ft necessary for patients treated with colloidal ra<licactive gold or phos- in place until the arrival of the Radiation Protection Supervisor.

phorus. The on!y hazard is leakage from the puncture wound Inade 1 If the contamination arises from a mixed beta-tramma emitter during the injection of the colloidal material. Surgical dressings and of medium wrgy such as I-131, protection against the beta radation l

bandages should be char.ged only as directed by the physician in charge. may be effected as de cribed above. If persormel remain at levt 6

?

~

Bandages or dressings which become stained shouM be monitored for feet from the covered spi:1. further immediate protection against the contamination. (The gold colloid will stain linen pink, red or purple.) gamms ra6ation is not required.

1f at any time the dres ng becomes damp, etained, or bloody, the physi,

. 1 y W c emnsan w m M a nh M, , n is pms ble that radioactive paracles wdl become airborne. In this case clan m charge of the case and the Radiation Protect. ion tapervuor shah be notiSed 2mmediately. If there is no drainage from the wound after the mom show!d be evacuated, the door and a!! windows and venti-the first few days, dressings rosy be handled in the usual maner. lators shedd be eiwd if poss11e, and a reg.on immediately outside the room msrked of as a radiation hanrd area. All persons evacuated frem the room s4c!l remsin mthin this designated area tmtil monitored by the Radiation Prctection Superviser.

3.6 Procedurce for Minimirine Radiation Harards Apociated with Accidental Contamination 3.7 Protection of Other Patients and Visitors frorn Radiation If there is any suspicion that accidental contaminstion has resulted from the patient's excreta or vomitus, from spillage, from rupture cf The maximum permissible dese equivalent for persons not occupa-sealed sources, or from other causes, the Radiation Proteetion Super-tionally exposed is 500 mrem per year, and planning shall be based on visor shall be notified imrnediatdy. While awaiting his arrival, im-mediate etcps shculd be taken to prevent the spread of the contamina- the objective that this level will not be exceeded for other patients or tien. An area containing the entire region of potential contamination for visitors exposed to ra.iistion from a patient containing radioactive material.

should be marked off. No person shouM he permitted to walk through this area. Any person who enters this area shosM not ! cave it withcut As far as visitors are concerned, there is little likalihood of their exceeding this dose, even if they make repeated visits, if they remain being monitored. Precautions shall be taken to prevent the spread of conhmination to other areas. about 6 feet or more from the patient, except for a brief period to shake hands, deliver mail, etc. Pregnant women and children should not, in

APPENDIX E RADIATION PROTECTION OFFICER INSPECTION (Ref. 48)

(PreferabTy con P fad in conjunction wit}ihospftal administrator)

1. Licensee:

2. Address:

3. License No.

and Date of Expiration:

4. Date of Inspection:

5. Inspe_ction Findings:

The inspection was an examination of the activities conducted under the above license as they relate to radiation safety and to compliance with the Nuclear Regulatory Commission's rules and regulations and the conditions of the above license. The inspection consisted of selective examinations of procedures and representative records, interviews with personnel, and observations by the Radia-tion Protection Officer. The findings as a result of this inspection are as follows:

I. Posting of Notices and Signs:

A. Rooms or areas were properly posted to indicate the presence of a RADIATION A_REA. 10 CFR 5 20.203(b) or s 34.42 Yes No N/A B. Rooms or areas were properly posted to indicate the presence of a HIGH~

RADIATION AREA. 10 CFR 5 20.203(c) or s 34.42 Yes No N/A C. Rooms or areas were properly posted to indicate the presence of an AIRBORNE RADI0 ACTIVITY AREA. 10 CFR 5 20.203(d)

Yes No N/A D. Rooms or areas were properly posted to indicate the presence of RADI0 ACTIVE MATERIAL. 10 CFR 5 20.203(e)

Yes No N/A E. Containers were properly labeled to indicate the presence of RADI0 ACTIVE MATERIAL. 10 CFR 5 20.203(f)(1) or (f)(2)

Yes No N/A F. A copy of the regulation on " Notices, Instructions and Reports to Workers: Inspections" was properly posted for use by TiidivniuliTs~

EaFtTcTpa~ ting in the licensed activities. 10 CFR Part 19,10 CFR 5 19.11(a)(1)

Yes No N/A 1

l G. A copy of the regulation on " Standards for Protection Against Radiation" was properly posted for use by the individuals partici-palin ~g~~iW the licensed activities. 10 CFR Part 20,10 CFR 6 19.ll(a)(1)

Yes No N/A E-1

H. Copies of the current license, license conditions, and amendments thereto were properly posted. 10 CFR 5 19.ll(a)(2)

Yes No N/A

1. Copies of the documents incorporated into the current license by reference were properly posted. 10 CFR 8 19.11(a)(2)

Yes No N/A J. A copy of the operating procedures applicable to licensed activities was properly posted. 10 CFR 1 19.ll(a)(3)

Yes No N/A K. Posting of documents specified in 10 CFR I 19.ll(a)(1,2,3) was not practicable; therefore the licensee posted notice which describes the documents and states where they may be examined. 10 CFR E 19.ll(b)

Yes No N/A L. Form NRC-3, " Notice to Employees," was posted in a sufficient number of places for use by the individuals who work in or frequent any portion of restricted areas. 10 CFR I 19.ll(c)

Yes No N/A M.

A copy of any notice of violation involving radiological working conditions, proposed imposition of civil penalty, or order issued pursuant to Subpart B or 10 CFR Part 2 was posted within 2 working days af ter the receipt of notice. 10 CFR 5 19.ll(a)(4),(e)

Yes No N/A N. A copy of the licensee's response, if any, to a notice of violation, etc. (10 CFR 519.ll(a)(4)) was posted within 2 working days af ter the dispatch of response by the licensee. 10 CFR 5 19.ll(a)(4),(e)

Yes No N/A

0. The documents posted in compliance with 10 CFR 519.ll(a)(4) and (e) remained posted for a minimum of 5 working days or until action correcting the violation was completed, whichever was later. 10 CFR 5 19.11(e)

Yes No N/A Date of Receipt of Violation:

Date of Dispatch of Response:

Date of Corrective Action:

Date on Which Documents Posted:

Date on Which Documents Removed _:

II. Records and Reports:

P. Records of current occupational radiation exposures of individuais were properly maintained on Form NRC-5.

10 CFR 5 20.401 or S 34.33(b)

Yes No N/A Q. Records of individual accumulated occupation dose were maintained for each radiation worker on Form NRC-4. 10 CFR 5 20.102 Yes No N/A E-2

R. Records or radiation surveys of all the working areas where the licensed material is used were maintained. 10 CFR H 20.201(b) or 5 30.43(d)

Yes No N/A Frequency of Survey:

Date of Last Survey:

S. Records of disposal of licensed radioactive material were properly maintained. 10 CFR 5 20.302, 5 20.302 Yes No N/A Frequency of Disposal:

Date of Last Disposal:

T. Records of receipt, transfer, disposal, export of licensed material were properly maintained. 10 CFR i 30.51, 5 40.61 Yes No N/A U. Records of leak tests were maintained as prescribed in the license.

10 CFR 6 34.25(c)

Yes No N/A Frequency of Leak Test:

Date of last Leak Test:

V. Records of isotope inventories were properly maintained to comply with item #8 of byproduct material license. 10 CFR 5 34.26 Yes No N/A Frequency of Isotope Inventory:

Date of Last Inventory:

W. Utilization logs of each isotope received were properly maintained.

10 CFR I 34.27 Yes No N/A X. Records of calibration of radiation survey instruments as required by the conditions of license were properly maintained. 10 CFR 5 34.24 Yes No N/A Frequency of Calibration:

Date of Last Calibration:

Y. Records of bioassay tests were maintained on all individuals per requirements of license. 10 CFR 9 20.108 Yes No N/A Frequency of Bioassay Test:

Date of last Bioassay Test:

E-3

Z. Records of the wipe-test data and results on determination of con-centrations of radioactive material present in the working areas were properly maintained. 10 CFR 5 201(a)

Yes No N/A Frequency of Wipe-Test:

Date of Last Wipe-Test:

III. Operating Procedures and Manuals:

1. The institutional radiation safety instruction program for all radiation workers and hospital employees is operational and effective.

10 CFR 5 19.12 Yes No N/A Frequency of Radiation Safet_y Instruction:

Date of Last Instruction Program:

2. A radiation safety procedures manual is written and copies are made available for the use of all the radiation workers, personnel involved in patient care and others who may handle radioactive material.

10 CFR 5 19.?2 Yes No N/A

3. Procedures for picking up, receiving and opening of the package containing radioactive material are available and are in routine use. 10 CFR 5 20.205 Yes No N/A 4 The Medical Isotope Committee meetings are held at periodic intervals to review the medical isotope program at the institution.

Yes No N/A

5. The local fire and police officials are infonned of the location and nature of radioactive materials in the institution.

Yes No N/A Fre_quency of Familiarization by Fire and Police Officials:

Date of Last Visit: m IV. Administrative Actions:

1. No items of noncompliance or unsafe conditions were found.

Radiation Protection Of ficer:

Signature and Date:

2. The following items of noncompliance related to each of the above sections were found.

Section I: ,-

Section II:

Section III:

Radiation Protection Of ficer:

Signatire and Date:

l E-4

3. The Radiation Protection Officer has explained and I understand the items of noncompliance listed in Item 2 of this section. The items of noncompliance will be corrected within the next days.

Chairman, Medical Isotope Committee:

Sijnature and Date:

i Reviewed by:

Da te Hospital Administrator E-5

TABLE 1 i ESTIMATED MINIMUM RADI ATION SAFETY STAFFING REQUIREMENTS FOR VARICUS CATEGORIES OF MEDICAL INSTITUTIONS

• l

~ PROFESSIONAL CA TEGORY RADIATION SOURCES TECHNICIAN TIME (HEALTH PHYSICS) TIME I Low-level clinical and research laboratories 6 man-hours per month 4 man-days /yr (plus daily supervision handling microcurie quantities of I-131. I-125, by full-time qualified staff radiolo-Cr-51, C-14, and H-3, plus radiographic units gist or other health professional) and fluoroscopes II Category I plus nuclear medicine diagnostics 1 full-time radiation 10 man-days /yr to 1/2 time by health safety technician (possibly physicist doing some minor part-time electronics maintenance)

III Category II plus teletherapy and/or radio- 1 full-time radiation 1 full-time health or radiological nuclide therapy and/or brachytherapy safety technician ** physicist (possibly performing some

?

additional radiotherapy and nuclear medicine calibrations)

IV Category III plus multi-megavolt 2 full-time technicians - 1 full-time health physicist and 1 or therapy radiation safety and more full-time radiological physicists electronics ** with some radiation safety responsibilities All personnel are in addition to clinical radiological physics requirements.

Plus proportionate secretarial-clerical assistance for correspondence and recordkeeping requirements.

REFERENCES

1. Title 10, Code of Federal Regulations, Part 20, " Standards for Protection Against Radiation,"

U.S. Government Printing Office, Washington, D.C.

2. U.S. Nuclear Regulatory Commission, " Operating Philosophy for Maintaining Occupational Radiation Exposures as Low as is Reasonably Achievable," Regulatory Guide 8.10, Washington, D.C.

3. National Bureau of Standards, " Permissible Dose from External Sources of lonizing Radiation,"

Handbook 59, Recommendations of the National Council on Radiation Protection (NCRP Report No. 17), Washington, D.C., September 24, 1954.

4. National Council on Radiation Protection and Measurements, " Review of the Current State of Radiation Protection Philosophy," Report No. 43, Washington, D.C., January 15, 1975.

5. National Academy of Sciences - National Research Council, "The Effects on Population of Exposure to Low Levels of lonizing Radiation," Washington, D.C.,1972.

l l

6. Federal Radiation Council, " Background Material for the Development of Radiation Protection Standards," Report No. 1. Washington, D.C., 1960.

l l 7. International Commission on Radiological Protection, " Implications of Commission Recom-l' mendations that Doses Be Kept As Low As Readily Achievable," Report No. 22, Pergamon Press, Elmsford, N.Y., 1974.

8. C. E. Braestrup and K. J. Vikterlof, " Manual on Radiation Protection in Hospitals ano General Practice," Vol.1, " Basic Protection Requirements," World Health Organization, Geneva, Switzerland, 1974.

9. Department of Health, Education, and Welfare, " Health Physics in the Healing Arts."

Publication No. (FDA) 73-8029, proceedings of the Seventh Midyear Symposium of the Health Physics Society, San Juan, Puerto Rico. December 1972.

10. R. D. Vanderwarker, Ed., "Use of Radioisotopes in Hospitals," American Hospital Association, Chicago, Ill., 1967.

11. Statement of Considerations, 10 CFR Part 20. " Standards for Protection Against Radiation,"

Federal Register 25, No. 174, U.S. Government Printing Office, Washington, D.C., 1960,

p. 8595.

12. Title 10, Code of Federal Regulations, Part 51, " Licensing and Regulatory Policy and Procedures for Environmental Protection," U.S. Government Printing Office, Washington, D.C., 1975,

13. R. Barrall, L. H. Lanzl, and J. W. Hilbert, "A Survey of Personnel Exposure in Nuclear Medicine," American Association of Physicists in Medicine, New York, N.Y.,1975.

14. R. Ice, " Establishment of a University Radiation Safety Office," Health Physics 20, ~~

pp. 444-446, 1971.

15. The following articles from DHEW Pub. No. 73-8029 (Ref. 9 ):

J. St. Gennain, " Operational Health Physics in Diagnosis" R. J. Cloutier and E. E. Watson, " Radiation Doses f rom Nuclear Medicine Procedures" F. Dobrowolski, " Health Physics in Radiotherapy" M. G. Mayes, R. L. Douglas, M. W. Carter, T. M. Grady, and E. van der Smissen,

" Study of Radiation Exposures from Technetium Generators at Three Hospitals" M. H. Lombardi, W. L. Beck, and R. J. Cloutier, " Survey of Radiopharmaceutical Use and Safety in Sixty-Nine Hospitals"

16. Y. Wang, Editor, " Handbook of Radioactive Nuclides," CRC Press, Cleveland, Ohio,1969.

R-1 U__ . _ - _ _ _ _ _ _ _ _ _ _ _ _ _

17 Comittee on Industrial Ventilation, American Conference of Governmental Industrial -

Hygienists, " Industrial Ventilation," Lansing, Mich., 1975.

18. H. Blatz, " Introduction to Radiological Health," McGraw-Hill, New York, N.Y., 1964.

19. National Council on Radiation Protection and Measurements, " Medical X-Ray and Gamma-Ray Protection for Energies up to 10 Mev -- Equipment Design and Use," NCRP Report No. 33, Washington, D.C., 1968.

20. National Council on Radiation Protection and Measurements, " Medical X-Ray and Gamma-Ray Protection for Energies up to 10 Mev -- Structural Shielding Design and Evaluation,"

NCRP Report No. 34, Washington, D.C., 1970. Reissued as NCRP Report No. 49, " Structural Shielding Design and Evaluation for Medical Use of X-Rays and Gamma Rays of Energies Up to 10 MeV," Sept. 15, 1976.

21. International Commission on Radiological Protection, " Report of Committee Five on the -

Handling and Disposal of Radioactive Materials in Hospitals and Medical Research Establish-ments," ICRP Report 5, Pergamon Press. Elmsford, N.Y. ,1965.

22. H. Blatz, Editor, " Radiation Hygiene Handbook," McGraw-Hill, New York, N.Y.,1959.

23. National Council on Radiation Protection and Measurements, " Safe Handling of Radioactive Materials," NCRP Report No. 30, Washington, D.C.,1964

24. National Council on Radiation Protection and Measurements, " Protection Against Radiation from Brachytherapy Sources," NCRP Report No. 40, Washington, D.C. ,1972.

25. National Council on Radiation Protection and Measurements, " Precautions in the Management of Patients Who Have Received Therapeutic Amounts of Radionuclides," NCRP Report No. 37, f Washington, D.C., 1970.

26. International Commission on Radiological Protection, " Protection of the Patient in Radio-nuclide Investigations," ICRP Publication No. 17, Pergamon Press, Elmsford, N.Y., 1969. -

27. American National Standards Institute, " Guidelines for Maintaining Cobalt-60 and Cesium-137 Teletherapy Equipment," ANSI N449-1974, New York, N.Y., Dec. 1973.

28. American National Standards Institute, " Procedures for Periodic Inspection of Cobalt-60 and Cesium-137," ANSI N44.2, Fourth Draf t, June 21, 1976 (J. Peter Veerling, Baptist Memorial Hospital, 899 Madison Avenue, Memphis, Tenn. 38146).

29. Department of Health, Education and Welfare, " Status and Future Manpower Needs of Physicists in Medicine in the United States," Publication No. (FDA) 74-8014, report of The Joint Comittee on Manpower Needs in Medical Physics of The American College of Radiology and The American Association of Physicists in Medicine, sponsored by the Bureau of Radiological Health. Washington, D.C., Nov. 1973.

30. International Atomic Energy Agency, " Safe Handling of Radionuclides," IAEA Safety Series No. 6. Vienna, Austria, 1973.

31. B. Branson, P. A. Feller, and V. J. Sodd, " Personnel Exposure from an Unshielded Pulmonary Ventilation System," Nuclear Medicine Lab., Cincinnati General Hospital, Cincinnati, Ohio, 1976.

32. L. M. Freeman, M.D. , and M. D. Blaufox, M.D. , editorial consultants, " Physicians' Desk Reference for Radiology and Nuclear Medicine," Medical Economics Co., Oradel, N.J. 1975/76.

33. L. T. Dillman, "Radionuclide Decay Schemes and Nuclear Parameters for Use in Radiation-Dose E.itimation," MIRD Pamphlet 4. Supplement No. 2 of the Journal of Nuclear Medicine, New York, N.Y., March 1969.

34. National Council on Radiation Protection and Measurements, " Basic Radiation Protection Criteria," NCRP Report No. 39, Washington, D.C. ,1971.

35. International Comission on Radiological Protection, " Protection Against Ionizing Radiation from External Sources," ICRP Report No. 15, Pergamon Press, Elmsford, N.Y., 1973.

R-2

36. U.S. Nuclear Regulatory Commission, " Instruction Concerning Frenatal Radiation Exposure,"

Regulatory Guide 8.13, Washington, D.C.

37. National Council on Radiation Protection and Measurements, " Radiation Protection for Medical and Allied Health Personnel," NCRP Report No. 48, Washington, D.C., 1976.

38. U.S. Nuclear Regulatory Commission, " Acceptable Concepts, Models, Equations, and Assumptions for a Bioassay Program," Regulatory Guide 8.9, Washington, D.C. , September 1973.

39. International Connission on Radiological Protection, " Report of ICRP Connittee II on Permissible Dose fnr Internal Radiation (1959), with Bibliography for Biological, t1athe-matical, and Physical Data " ICRP Publication 2, Health Physics 3, Pergamon Press, Elmsford, N.Y., 1960.

40. International Commission on Radiological Protection, " Recommendations of the ICRP,1362, Supplement to ICRP Publication 2 " ICRP Publication 6, Pergamon Press, Elmsford, N.Y. ,1964.

41. International Commission on Radiological Protection, "Reconnendations of the International Comnission on Radiological Protection," ICRP Publication 9, Pergamon Press, Elmsford, N . Y . , 19 59.

42. International Connission on Radiological Protection, " Evaluation of Radiation Doses to Body Tissues from Internal Contamination Due to Occupational Exposure," ICRP Publication 10, Pergamon Press, Elmsford, N.Y., 1968.

43. International Commission on Radiological Protection, " Assessment of Internal Contamination Resulting from Recurrent or Prolonged Uptakes," ICRP Publication 10A, Pergamon Press, Elmsford, N.Y., 1971.

44. International Commission on Radiological Protection, " General Principles of Monitoring for Radiation Protection of Workers," ICRP Publication 12, Pergamon Press, Elmsford, N.Y. ,1969.

45. International Commission on Radiological Protection, " Reference Man," ICRP Publication 23, Pergamon Press, Elmsford, N.Y., 1975.

l

46. W. S. Snyder, Mary R. Ford, G. G. Warner, and Sarah B. Watson, "A Tabulation of Dose Equivalent per Microcurie-Day for Source and Target Organs of an Adult for Various Radio-nuclides," ORNL-5000, National Technical Infonnation Service, Springfield, Va. ,1974.

47. National Council on Radiation Protection and Measurements, " Medical Radiation Exposure of Pregnant and Potentially Pregnant Women," NCRP Report No. 54, July 15, 1977.

48. S. M. Brahmavar, S. M. Zubi, and J. P. Sullivan, " Compliance Tests and Radiation Safety Procedures for Broad and Specific Medical Byproduct Material Licenses," Proceedings of the 22nd Annual Meeting of the Society of Nuclear Medicine, 1975. (Available from Dr. S. M.

Erahmivar, Department of Pathology, Medical Center of Western Massachusetts, Springfield, Mass.)

In addition to the cited references listed above, there are a number of national and international organizations that have published recomendations and guides providing detailed methods, data, and scientific information for use in establishing radiation protection programs aimed at main-taining radiation exposures as low as reasonably achievable. The organizations and their addresses are listed below:

> American Association of Physicists in Medicine (AAPM)

Radiation Protection Committee 335 East 45th Street New York, N.Y 10017 (The AAPM Radiation Protection Committee has developed guidance for radiation protection and reducing exposures ALARA in the various types of procedures in medical institutions using radioactive materials.)

American Conference of Governmental Industrial Hygienists Committee on Industrial Ventilation P.O. Box 453 Lansing, Mich. 48902 R-3

(This committee regularly updates its " Industrial Ventilation" manual, which provides engineering data and methods equally applicable to the design of medical facilities handling radioactive materials.)

American Industrial Hygiene Association (AIHA) 66 S. Miller Road Akron, Ohio 44313 (The AIHA has established a laboratory for accreditation of laboratories Carrying out analyses related to the health and safety of employees and is proposing to extend this program to bicassay of radioactive materials for internal dose estimation. They may be contacted, as well as HPS, for expert assistance on planning bioassay services or for ventilation design and general laboratory safety considerations.)

American National Standards Institute, Inc. (ANSI)

IEEE Standards Office 345 East 47th Street New York, N.Y. 10017 Bureau of Radiclogical Health (BRH)

Food and Drug Administr0 tion Public Health Service U.S. Department of Healtu Education, and Welfare Rockville, Md. 20852 Energy Research and Development Administration (ERDA)

Washington, D.C. 20545 Federal Radiation Council (FRC)

(Functions of the Federal Radiation Council have now been transferred to the Environmental Protection Agency; documents are available from U.S.

Government Printing Office Washington, D.C. 20402.)

International Atomic Energy Agency (IAEA)

Publishing Section Kartner Ring 11 P.O. Box 590 A-10ll Vienna, Austria (Publication orders from the U.S.A. should be addressed to:

UNIPUB, Inc., P.O. Box 433, New York, N.Y. 10016.)

International Commission on Radiation Units and Measurements (ICRU) 7910 Woodmont Avenue Washington, D.C. 20014 (Order publications from ICRU Publications, P.O. Box 30165, Washington, D.C. 20014.)

International Commission on Radiological Protection (ICRP)

(Order publications from Pergamon Press, Inc., Elmsford, N.Y. 10523, or through bookstores in the United States.)

International Labour Office (ILO)

Geneva, Switzerland (Most publications of ILO useful in medical institutions are available from other agencies as joint publications.)

Joint Comission on Accreditation of Hospitals (JCAH)

John Hancock Building B75 N. Michigan Avenue Chicago, Ill. 60611 Attention: Publica tions R-4

(The JCHA has published a manual of standards, including environmen aspects of radiation safety, which contains the basis for their host inspection program for accreditation. These star.Jards will be issue revised form as available.)

Joint Committee on Atomic Energy (JCAE)

U.S. Congress Washington, D.C. 20510 (Publications are available from the U.S. Government Printing Office.)

Medical Internal Radiation Dose Committee (MIRD)

Society of Nuclear Medicine 475 Park Avenue South New York, N.Y.10016 (The MIRD committee has in recent years issued a number of excellent compilations of data and methods for calculating doses to humans from radionuclides used in medicine. These same data and methods are useful I

in monitoring and estimating both internal and external occupational exposures to hospital employees.)

National Academy of Sciences - National Research Council (NAS-NRC) 2101 Constitution Avenue, N.W.

Washington, D.C.

National Council on Radiation Protection and Measurements (NCRP) 7910 Woodmont Avenue f Washington, D.C. 20014 (Order publications from NCRP Publications. P.O. Box 30175, Washington, D.C. 20014.)

l National Institute for Occupational Safety and Health and National Institute for Environmental Health Sciences (NIOSH and NIEHS)

Department of Health, Education, and Welfare Washington, D.C.

(Publications are available from the National Technical Infonnation Service, Springfield Va. 22151. )

Standards Committee Health Physics Society (HPS) 4720 Montgomery Lane Bethesda, Md. 20014 l World Health Organization (WHO)

Distribution and Sales Service 1211 Geneva 27, Switzerland R-5

1 UNITE D STATES F NUCLEAR REGULATORY COMMISSION ]

W ASHINGTON, D. C. 20555 Post A G E ANu s E rs e Ato U.S N U C LL A H H E G U L A T O ff V W O f f I CI A L. D USI N E SS coMMibstoN PE N ALT V F OR PRIV ATE USL, $300 U S Matt b

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