Home

Guide for the Preparation of Applications for Medical Use Programs

1. APPENDIX F Model Radiation Safety Committee Charter and Radiation Safety Officer Delegation of Authority See 35 21 35 22 and 35 23 You may use the following text as it appears here saying on your application We will issue the model Radiation Safety Committee Charter and Radiation Safety Officer Delegation of Authority that was published in Appendix F to Regulatory Guide 10 8 Revision 2 If you prefer you may develop your own statement of authority duties administrative procedures and delegation of authority If you do so you should consider for inclusion all the features in the model text and carefully review the requirements of 35 22 Say on your application We will issue the Radiation Safety Committee Charter and Radiation Safety Officer Delegation of Authority that are appended as ATT 10 1 and append your charter and delegation MODEL CHARTER Charge The Committee shall 1 Ensure that licensed material will be used safely This includes review as necessary of training programs equipment facility supplies http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 30 of 83 PEPA S and procedures Ensure that licensed material is used in compliance with NRC regulations and the institutional license Ensure that the use of licensed material is consistent with the ALARA philosophy and program Establish a table of investigational levels for individual oc
2. The purpose of a filing system is to allow for the quick access of records The system should be constructed to allow a person who is not familiar with the system to use it with minimal training If you have not established a system the one described below may be helpful In addition to NRC licensed activities it includes sections for State licensed natural and accelerator produced radioactive material programs x ray survey and maintenance reports that are sometimes maintained by the Radiation Safety Officer and various safety committees The filing system described contains two parts The first part includes Sections A and 0 9 for files that are small or occasionally accessed The second part consists of five looseleaf notebooks used to file records that are large frequently accessed or easily filed in alphabetical or chronological order Section A Active Projects Set up an individual file for each project e g planning a new radioisotope lab or x ray installation or a research project Label each file with a short title File chronologically with new material in front For example Shielding calculations for new x ray room TLD project Registration and travel to summer meeting Section O Forms http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 67 of 83 Set up a file for master copies of the forms you use in your facility and a file for copies of each form Label the fil
3. Regulatory Guide 10 2 Guidance to Academic Institutions Applying for Specific Byproduct Material Licenses of Limited Scope Regulatory Guide 10 5 Applications for Type A Licenses of Broad Scope Draft Regulatory Guide FC 414 4 8 Guide for the Preparation of Applications for Licenses in Medical Teletherapy Programs Other NRC Publications A Brodsky Principles and Practices for Keeping Occupational Radiation Exposures at Medical Institutions As Low As Reasonably Achievable NUREG 0267 Revision 1 USNRC Washington DC October 1982 N L McElroy and A Brodsky Radiation Protection Training for Personnel Employed in Medical Facilities NUREG 1134 USNRC Washington DC May 1985 Technical Reports Bureau of Radiological Health Radiation Safety in Nuclear Medicine A Practical Guide Department of Health and Human Services HHS Publication FDA 82 8180 November 1981 Center for Devices and Radiological Health Recommendations for Quality Assurance Programs in Nuclear Medicine Facilities HHS Publication FDA 85 8227 October 1984 International Atomic Energy Agency IAEA Monitoring of Radioactive Contamination on Surfaces Technical Report Series No 120 1970 2 IAEA Handbook on Calibration of Radiation Protection Monitoring Instruments Technical Report Series No 133 1971 2 International Commission on Radiological Protection ICRP General Principles of Monitoring for Radiation Protection of Workers Report No
4. 1 Unrestricted areas personal clothing 200 2 000 2 Restricted areas protective clothing used only in 2 000 20 000 restricted areas skin http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 50 of 83 APPENDIX O Model Procedure for Monitoring Calculating and Controlling Air Concentrations See 20 103 20 106 20 201 35 90 and 35 205 WORKER DOSE FROM NOBLE GASES Item 10 13 1 Noble gases such as xenon in the air present an external source of radiation exposure that must be calculated Many commercially available dosimeters and survey instruments are not capable of accurately measuring worker doses from immersion in noble gases If you will collect spent gas in a shielded trap with an effluent air contamination monitor and will follow the monitor manufacturer s instructions for checking its accuracy and constancy you may respond to Item 10 13 1 by saying We will collect spent noble gas in a shielded trap and monitor the trap effluent with an air contamination monitor that we will check regularly according to the manufacturer s instructions If you will collect spent gas in a shielded trap and will follow the model procedure for checking trap effluent you may respond to Item 10 13 1 by saying We will collect spent noble gas in a shielded container and will establish and implement the model procedure for checking trap effluent that was published in Appendix O 3 to Regulat
5. These need not be on hand if the dose calibrator accuracy test is done by a contract service The leak test service may be done in house or performed as a contract service Leak test wipes cannot be measured in a dose calibrator and a GM survey meter may not be sensitive enough to detect contamination on a wipe sample Usually a well type Nal T1 crystal with a ratemeter is necessary to assay gamma emitter leak test wipes To determine the efficiency of detection a sealed source with the same radioisotope as the source being tested is used but its activity should be between 0 1 and 10 microcuries This activity will be certified by the manufacturer to an accuracy within a few percent The hot lab area monitor usually has a GM detector and the scale may be labeled in cpm or mR hr It should be sufficiently sensitive to detect an unshielded patient dose left lying unshielded anywhere in the hot lab The flood source for gamma cameras may be either one that is sealed or one that is filled by the user The sealed sources usually contain about 5 millicuries of Co 57 The sources that can be filled by the user usually have a removable screw in a port through which radioactive material can be injected each morning PLES bar orthogonal hole and quadrant phantoms are used to monitor geometric linearity and resolution capability in gamma cameras This type of test should be run weekly according to the instructions supplied by the manufacturer or the instru
6. a rule on affected licensees 4 AMENDMENTS TO LICENSE A licensee must receive a license amendment before changing the scope of the program changing the Radiation Safety Officer or teletherapy physicist or adding to the staff of authorized users See 35 13 for the specific requirements An application for an amendment must be filed in duplicate either on NRC Form 313 or as a letter and must be signed as described in Item 13 If the amendment application is the first one submitted after the effective date of the revision of 10 CFR Part 35 April 1 1987 the NRC will use this opportunity to list the Radiation Safety Officer and teletherapy physicist on the license The teletherapy physicist s credentials must be submitted as part of the amendment application http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 19 of 83 5 RENEWAL OF LICENSE An application for the renewal of a license should be filed at least 30 days before the expiration date This will ensure that the license does not expire before final action on the application has been taken by the NRC as provided for in paragraph 30 37 b of 10 CFR Part 30 The application for renewal must be filed in duplicate on NRC Form 313 The application for renewal may reference attachments that were previously submitted For example See ATT 10 7 dated November 14 1985 6 IMPLEMENTATION The purpose of this section is to provide inform
7. e 4 AMENDMENTS TO LICENSE e 5 RENEWAL OF LICENSE e 6 IMPLEMENTATION 1 INTRODUCTION 1 1 GENERAL The Nuclear Regulatory Commission NRC regulates the intentional internal or external administration of byproduct material or the radiation therefrom to human beings This type of use is called medical use and a specific license is required The regulations governing medical use are contained in 10 CFR Part 35 Medical Use of Byproduct Material The NRC usually issues a single byproduct material license to cover an entire radioisotope program except teletherapy nuclear powered pacemakers and irradiators Separate licenses are not normally issued to different departments of a hospital or to individuals employed by a hospital A license applicant should carefully study this guide and all the regulations identified in Section 1 2 and should then complete the application form NRC Form 313 The NRC may request additional information when necessary to provide reasonable assurance that the http www nrc gov NRC RG 10 10 008r2 htm1 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 4 of 83 applicant has established an adequate radiation protection program 1 1 1 Purpose of Guide This guide is designed to describe the type and extent of information needed by the NRC to evaluate an application for a medical use license and to describe the medical use byproduct materia
8. www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 29 of 83 quadrant of the crystal d Process the images as if they were images of a patient Mark them clearly to indicate image orientation source activity and date e Retain the images for 2 years 3 Perform the following safety checks after repairs and quarterly a Check the motion interlocks by activating the emergency off switches on the camera With the camera in motion activation of the emergency off switch should stop the motion If this might jeopardize imaging components in the system perform only the checks described in paragraph 3 b b Check the motion switches Put the camera in motion and first release just the direction switch to stop the motion Then put the camera back in motion and release just the dead man switch Test all motion switches and all directions in this manner Release of either the motion switch or the dead man switch alone should disable the camera motion If this is not the case repair the camera before clinical use 4 Set the equipment in the same manner each time checks are run Make a record of all these checks Keep a separate file or ring binder for each camera Retain the record for 2 years Ventilation If gases or aerosols will be used check the ventilation supply exhaust vents and collection devices for operation with tissue paper or a velometer There is no need to keep a record of these checks
9. Clinical Procedures Training Log Exhibit 5 Exhibits 4 and 5 may be used as worksheets when preparing Supplements A and B If you have specific questions after careful review of this guide contact the NRC material licensing staff at the appropriate address as specified in Section 2 of this guide Item 1 LICENSE INFORMATION For a new license check subitem A For an amendment to an existing license check subitem B For a renewal of an existing license check subitem C Item 2 APPLICANT S NAME AND MAILING ADDRESS If you are an individual you should be designated as the applicant only if you are acting in a private capacity and the use of the radioactive material is not connected with your employment with a corporation or other legal entity Otherwise you the applicant should be the corporation or other legal entity applying for the license The address specified here should be your mailing address for correspondence This may or may not be the same as the address at which the material will be used as specified in Item 3 Item 3 LOCATIONS OF USE You should specify each location of use by the street address city and State or other descriptive address such as 5 miles east on Highway 10 Anytown State to allow us to easily locate your facilities A post office box address is not acceptable If byproduct material is to be used at more than one location you must give the specific address of each location In Items 5 through 11 of t
10. M 10 11 Implant source use records NA NA NA Z NA NA M 10 12 Area survey procedures wt wf F wf NA vr N 10 13 Air concentration control NA VY NA NA NA NA O 10 14 Radiopharmaceutical therapy NA NA Pa NA NA NA P 10 15 Implant therapy NA NA NA Pi NA NA Q 10 16 Other safety procedures NA NA NA NA NA Y 11 1 Waste disposal Pi Y Pa Pi Y NA R 11 2 Other waste disposal NA NA NA NA NA VY Item 8 TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS 8 1 Training Program Describe your training program for individuals who work with or in the vicinity of radioactive material described in Part 35 See Appendix A of this guide 8 2 Other Training Program Describe your training program for individuals who handle radioactive material other than the Part 35 material that you listed in Item 5 of this application Append it as ATT 8 2 Item 9 FACILITIES AND EQUIPMENT http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 14 of 83 9 1 Annotated Drawing Submit an annotated drawing of the room or rooms and adjacent areas where byproduct material will be used Append it as ATT 9 1 Note the following 1 The scale Use the same scale preferably 1 4 inch 1 foot for all drawings 2 The direction of north 3 Room numbers and principal use of each room or area for example in vitro hot lab waiting examining imaging reading office file fresh materials storage radioact
11. Section 8 State Regulated Sources 8 1 8 2 Personnel Exposures Spills or Losses with No Personnel Exposure Procedural Incidents X ray Registration Sheets NARM License Application License Set up an individual file for each piece of radiographic equipment The file should contain the user s manual guarantee service reports and inspection and calibration reports File by room number For portable x ray machines file by manufacturer s name or normal storage location Section 9 Facility Description Set up files for blueprints drawings and permanently installed equipment such as incinerators fume hoods and walk in boxes Loose Leaf Notebooks http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 70 of 83 1 Dosimetry Service Monthly Packing Slips Checkmark each name when the monitor is returned at the end of the monitor period This will highlight persons who are not returning monitors promptly for processing 2 Personnel Dosimetry Individual Applications Behind each individual s application form file copies of previous employment exposure incidents requests for previous employment exposure and bioassay results 3 Budget and Purchase Orders 4 NRC Regulatory Guides Divisions 8 and 10 5 Standard Operating Procedures 6 NRC Rules and Regulations APPENDIX W Bibliography Title 10 Code of Federal Regulations Part 19 Notices Instructions and Rep
12. a standard certified within 5 percent accuracy by the National Bureau of Standards 3 A source that has approximately the same photon energy as the environment in which the calibrated device will be employed should be used for the calibration 4 The source should be of sufficient strength to give an exposure rate of about 30 mR hr at 100 cm Minimum activities of typical sources are 85 millicuries of Cs 137 or 21 millicuries of Co 60 5 The inverse square law and the radioactive decay law must be used to correct for change in exposure rate due to changes in distance or source decay 6 A record must be made of each survey meter calibration 7 A single point on a survey meter scale may be considered satisfactorily calibrated if the indicated exposure rate differs from the calculated exposure rate by less than 10 percent 8 Three kinds of scales are frequently used on survey meters a Meters on which the user selects a linear scale must be calibrated at no less than two points on each scale The points should be at approximately 1 3 and 2 3 of full scale b Meters that have a multidecade logarithmic scale must be calibrated at no less than one point on each decade and no less than two points on one of the decades Those points should be at approximately 1 3 and 2 3 of the decade c Meters that have an automatically ranging digital display device for indicating rates must be calibrated at no less than one point http www nrc gov NRC RG 10 10 008r2 ht
13. a higher concentration there may be a manufacturing defect that should be reported under paragraph 21 21 b of 10 CFR Part 21 The model procedure for measuring molybdenum concentration is based on the use of a molybdenum breakthrough pig Your dose calibrator manufacturer will usually supply as an option a molybdenum breakthrough pig made of lead The pig is usually thick enough to shield all the technetium photons but only a fraction of the molybdenum photons The manufacturer will specify the Mo 99 correction factor to convert from measured Mo 99 to total Mo 99 The following model procedure may be used to measure the molybdenum concentration in Mo 99 Tc 99m generator elution If you will follow the model procedure you may say on your application We will establish and implement the model procedure for measuring and recording molybdenum concentration that was published in Appendix M 3 to Regulatory Guide 10 8 Revision 2 If you prefer you may develop your own molybdenum concentration procedure for review If you do so you should consider for inclusion all the features in the model procedure and carefully review the requirements of 35 204 Say on your application We have developed a procedure for measuring and recording molybdenum concentration for your review that is appended as ATT 10 10 and append your http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 47 of 83 procedure f
14. a separate line item and note its total activity in mCi Table 1 Byproduct Material Amount Purpose 5 a Material in 35 100 As needed 6 a Medical use 5 b Material in 35 200 As needed 6 b Medical use 5 c Material in 35 300 As needed 6 c Medical use 5 d Implant Material in 35 400 mCi 6 d Medical use 5 e Eye applicator in 35 400 mCi 6 e Medical use 5 f Material in 35 500 As needed 6 f Medical use Note Broad scope medical use applicants may request Any byproduct material with atomic numbers 3 through 83 for medical use If you need other items for example more byproduct material for in vitro testing than is allowed under 31 11 depleted uranium for linear accelerator shielding a survey meter calibration source a teletherapy dosimetry system constancy check source or material for in vitro animal or human studies or authorization to participate in a protocol approved by a Radioactive Drug Research Committee that has been approved by the Food and Drug Administration make a separate line entry for each item Do not list sources that are authorized in 35 58 Number each line entry consecutively following the Part 35 material Each line entry must identify the radionuclide the physical form maximum amount of hand expressed in mCi and the purpose for which the material will be used If you do not want all the material listed in a Part 35 section you must identify line by line the material that you do want from
15. and carefully review the requirements of 35 59 Say on your application We have developed a leak test procedure for your review that is appended as ATT 10 3 and append your leak test procedure MODEL PROCEDURE 1 Make a list of all sources to be tested This should include at least the isotope the activity on a specified date and the physical form 2 If you will be testing sources stronger than a few millicuries set out a survey meter preferably with a speaker so you can monitor your exposure rate 3 Prepare a separate wipe sample for each source A cotton swab injection prep pad filter paper or tissue paper is suitable Number each wipe so you will know for which source it is to be used Samples should be taken as follows a For small sealed sources it may be easier to wipe the entire accessible surface area Pay particular attention to seams and joints However do not wipe the port of beta applicators b For larger sealed sources and devices survey meter calibrator bone mineral analyzer source take the wipe near the radiation port and on the activating mechanism c For teletherapy machines take the wipe with the source in the off position Wipe the area near the shutter mechanism taking care to touch neither field light and mirror nor crosshairs Also wipe the primary and secondary collimators and trimmers d If you are testing radium sources at the same time you are testing NRC licensed sources they should also be che
16. contain the following information a For routinely used materials 1 Written records that identify the authorized user or department isotope chemical form activity and supplier will be made 2 The above records will be checked to confirm that material received was ordered through proper channels b For occasionally used materials e g therapeutic dosages 1 The authorized user who will perform the procedure will make a written request that indicates the isotope radiopharmaceutical activity and supplier 2 The person who receives the material will check the physician s written request to confirm that the material received is what was ordered http www nrce gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 42 of 83 3 For deliveries during normal working hours the RSO will tell carriers to deliver radioactive packages directly to a specified area 4 For deliveries during off duty hours the RSO will tell security personnel or other designated persons to accept delivery of radioactive packages in accordance with procedures outlined in the sample memorandum below Sample Memorandum MEMO TO Chief of Security FROM Radiation Safety Officer SUBJECT Receipt of Packages Containing Radioactive Material The security guard on duty shall accept delivery of packages containing radioactive material that arrive during other than normal working hours Packages should be placed on a cart or wheel
17. current list of Agreement States including names addresses and telephone numbers of responsible officials may be obtained upon request from the Material Licensing Branch U S Nuclear Regulatory Commission Washington DC 20555 or from NRC s Regional Offices whose addresses are listed below If you are a non Federal organization that wishes to possess or use licensed material in one of these Agreement States your application should be filed with the State s radiation control program and not with the NRC If you are located in Connecticut Delaware District of Columbia Maine Maryland Massachusetts New Hampshire New Jersey New York Pennsylvania Rhode Island or Vermont send your applications to the U S Nuclear Regulatory Commission Region I Nuclear Material Section B 631 Park Avenue King of Prussia PA 19406 If you are located in Alabama Florida Georgia Kentucky Mississippi North Carolina Puerto Rico South Carolina Tennessee Virginia Virgin Islands or West Virginia send your applications to the U S Nuclear Regulatory Commission Region II Material Radiation Protection Section 101 Marietta Street Suite 2900 Atlanta GA 30323 If you are located in Illinois Indiana Iowa Michigan Minnesota Missouri Ohio or Wisconsin send your applications to the U S Nuclear Regulatory Commission Region III Material Licensing Section 799 Roosevelt Road Glen Ellyn IL 60137 If you are located in Arkansas Colorado Idaho Ka
18. hour use the abbreviations only in calculations or log 4 Identify by name or office who is responsible for doing each task Room Changes 1 2 3 4 5 6 7 8 9 Why is the change needed What materials and how much of each will be used in the room Can the room be secured in case of spills Can the room surfaces be cleaned Is the room adequately ventilated Does the room provide radiation shielding What are the anticipated doses each week in the room and in surrounding areas What are surrounding areas used for What might they be used for in the future Can the old room be cleaned surveyed and released for unrestricted use Equipment Changes 1 Ze 3 Why is the change needed Was the equipment designed for the intended purpose For detection and measuring equipment a What is the lowest level of detection for the equipment b What is the level of detection required c Will the instrument be compromised by ambient radiations light temperature humidity or chemicals in the area d In case it fails is backup equipment available and can it be repaired in a timely fashion For protection equipment a What level of protection does it provide b What is the required level of protection c In case it fails is backup equipment available and can it be repaired in a timely fashion http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 62 of 83
19. not been prepared A copy of the draft value impact statement is available for inspection and copying for a fee at the Commission s Public Document Room at 1717 H Street NW Washington DC under Task FC 415 4 n If the applicant is a university with a teaching hospital that operates under a separate annual budget and has been issued multiple licenses the applicant should check the box that most closely approximates the annual operating budget of the entity that is the applicant either the university or the teaching hospital 2 Co 57 and Ra 226 are not subject to NRC licensing the appropriate State agency should be consulted to determine its requirements for http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 83 of 83 possessing this material 3 The NRC has emphasized that the investigational levels in this program are not new dose limits but as noted in ICRP Report 26 Recommendations of the International Commission on Radiological Protection serve as check points above which the results are considered sufficiently important to justify investigations 4 Not normally applicable to medical use operations except those using significant quantities of beta emitting isotopes 5 The person who is authorized to make commitments for the administration of the institution e g hospital administrator 6 Title 10 of the Code of Federal Regulations is available from the Superintendent
20. of 1 DAC for 1 year 2000 hours would result in either a committed effective dose equivalent of 5 rems 50 mSv or a committed dose equivalent of 50 rems 0 5 Sv to any individual organ or tissue with no consideration for the contribution of external dose In order to show compliance with the occupational dose limit of 5 rems 50 mSv a facility must consider the contributions of internal and external doses prior to calculating ventilation and gas clearance time Appendix O to this Regulatory Guide 10 8 provides model procedures for calculating worker doses from concentrations of gases in work areas and for calculating spilled gas clearance times The procedure states that the MPC values for the radionuclide of interest should be used in the calculations To implement the revised Part 20 the DAC value for the radionuclide of interest in conjunction with the contribution of external dose must be used instead of the MPC value For example consider the following simplified approach to determining required ventilation rates in an area where xenon 133 procedures will be performed Example A new room is being designed in an existing nuclear medicine department where xenon 133 ventilation studies will be performed You are asked to calculate the minimum ventilation rates required to maintain compliance with the occupational dose limits 1 Determine the highest dose to an individual from all external radiation for the previous 12 month period by reviewin
21. phantom in microcuries and associated counts per minute the counts per minute from the worker s thyroid the calculated thyroid burden and date 11 As the therapy proceeds pick up waste for transfer to a decay in storage or decontamination area 12 Do not release any patient until either the exposure rate from the patient is less than 5 millirem per hour at 1 meter or the retained radioactivity is less than 30 millicuries see 35 75 If you use the exposure rate standard as the release criterion measure it with a radiation measurement survey meter at a distance of 1 meter from the umbilicus while the patient is standing or if the patient is not ambulatory 1 meter from the bedside with the patient supine 13 Before using the room for general occupancy it must be decontaminated and released to the Admitting Office a Remove all absorbent paper and place it in the appropriate container b Transfer all containers to a decay in storage or decontamination area c Use aradiation detection survey meter to check for room contamination Clean contaminated areas until removable contamination is less than 200 dpm 100 cm d Call the Housekeeping Office to remove the cleaning restriction and call the Admitting Office to return the room to the vacant list oe Exhibit 18 Radiation Safety Checklist for Iodine Therapy over 30 Millicuries may also be helpful to you APPENDIX Q Model Procedure for Radiation Safety During Implant Therapy S
22. prepared for 10 CFR Part 20 Standards for Protection Against Radiation 56 FR 23360 provides the regulatory basis for this appendix and examines the costs and benefits of the rule as implemented by the guide A copy of the Regulatory Analysis for the Revision of 10 CFR Part 20 PNL 6712 November 1988 is available for inspection and copying for a fee at the NRC Public Document Room 2120 L Street NW Washington DC as an enclosure to Part 20 LIST OF EXHIBITS Exhibit Page 1 NRC Form 313 Application for Material License EXH 3 Privacy Act Statement EXH 4 2 Supplement A Training and Experience EXH 5 3 Supplement B Preceptor Statement EXH 6 Supplement B Preceptor Statement Continued EXH 7 4 Resident s Support Technology Training Task Log EXH 8 5 Resident s Clinical Procedures Training Log EXH 9 6 Layout Diagram EXH 11 7 Survey Meter Calibration Report EXH 12 Survey Meter Calibration Report Example EXH 13 8 Dose Calibrator Linearity Test EXH 14 Dose Calibrator Linearity Test Example EXH 15 9 Dose Calibrator Geometry and Accuracy EXH 16 Dose Calibrator Geometry and Accuracy Example EXH 17 http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio 10 11 12 13 14 15 16 17 18 19 20 21 Radioactive Spill Report Radioactive Spill Report Example Radioactive Spill Contamination Survey Radioactive Spill Contaminati
23. radiation levels if the package is labeled according to U S Department of Transportation rules i e labeled with White I Yellow I or Yellow IID as containing radioactive material or if there is evidence of damage to the package Such packages must be monitored for external radiation levels and surface contamination within 3 hours after receipt if received during working hours or within 3 hours from the beginning of the next working day if received after working hours in accordance with the requirements of 10 CFR 20 1906 The NRC Regional Office and the final delivery carrier must be notified immediately if removable contamination exceeds the limits of 10 CFR 71 87 1 or the external radiation levels exceed the limits of 10 CFR 71 47 Note that these Appendix X procedures for receiving and opening packages do not exempt packages containing less than Type A quantities of radioactive material from removable contamination surveys as does 10 CFR 20 205 b and Appendix L to this Regulatory Guide 10 8 Therefore it may be necessary for a licensee to revise current package opening procedures to reflect the changes in the revised Part 20 10 EFFLUENT RELEASES TO SEWER In the revised Part 20 10 CFR 20 2003 allows licensees under certain quantity release constraints to discharge licensed material into sanitary sewers if the material is readily soluble in water or if the material is readily dispersible biological material Dispersible in this context means
24. radiation measurement survey meter can actually measure mR hr The detector is an ionization chamber which is usually much larger than a GM tube The scale is labeled in mR hr and the most sensitive scale usually will have a full scale deflection between 1 and 10 mR hr The dose calibrator uses an ionization chamber or GM detectors to determine the amount of radiation given off by a syringe or vial containing radioactive material The logic system within the calibrator can then calculate the amount of radioactivity in the sample Most dose calibrators have a digital display with either a select range switch or an automatic range switching circuit The final display is in microcuries millicuries or curies A dose calibrator can measure from a few microcuries to a few curies It is not sensitive enough to measure contamination wipe samples A constancy check source is a sealed source with the date of manufacture radioisotope and approximate activity noted A dedicated check source is a long lived radioactive source used to check the day to day constancy of an instrument The same source a dedicated source must be used every day so that the user knows what reading to expect from the instrument The source may also be used for other purposes The sealed sources for dose calibrator accuracy are also sealed sources with the date of manufacture and radioisotope noted However the activity will be certified to within a few percent by the manufacturer
25. s instructions You do not have to monitor the trap effluent of single use devices If you are not monitoring reusable trap effluent or if you are exhausting spent aerosol to the atmosphere you must estimate worker dose by calculation You do not have to submit the calculations but you should keep them for NRC review during inspections If you will follow http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 51 of 83 the model procedure below for calculating worker dose from aerosols you may respond to Item 10 13 2 by saying We will follow the model procedure for calculating worker dose from aerosols that was published in Appendix 0 1 to Regulatory Guide 10 8 Revision 2 If neither of the above apply you may develop your own procedure for review If you do so you should consider all the above information and carefully review the requirements of 20 103 20 106 20 201 35 90 and 35 205 Say on your application We have developed a procedure for monitoring worker dose due to aerosol concentrations that is appended as ATT 10 13 2 and append your procedure for monitoring worker dose from aerosols 0 1 MODEL PROCEDURE FOR CALCULATING WORKER DOSE FROM CONCENTRATIONS OF GASES AND AEROSOLS IN WORK AREAS 1 Collect the following data a Estimated number of studies per week b Activity to be administered per study Estimated activity lost to the work areas per study you may assu
26. submitted to demonstrate their ability to manage radiation safety programs or to work safely with radioactive materials Home addresses and home telephone numbers should be submitted only if they are part of an emergency response plan Dates of birth Social Security numbers and radiation dose information should be submitted only if specifically requested by NRC You should file your application in duplicate Retain one copy for yourself because the license will be issued based on the statements and representations in your application and any supplements to it as well as the requirements in the regulations If you wish to possess or use licensed material on Federal property or in any State subject to NRC jurisdiction you should file your application with the NRC Regional Office for the State in which the material will be possessed or used The exceptions to the above are the United States Air Force and Navy and persons wishing to distribute exempt material under 10 CFR Part 32 Subpart A who should file http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 8 of 83 their applications directly with the U S Nuclear Regulatory Commission Division of Fuel Cycle and Material Safety Washington DC 20555 Many States have entered into agreements with the NRC that give them the authority to license radioactive materials used or possessed within their borders These States are called Agreement States A
27. the section Item 7 INDIVIDUALS RESPONSIBLE FOR RADIATION SAFETY PROGRAMS THEIR TRAINING AND EXPERIENCE Responsible individuals are the authorized users the RSO and for teletherapy the teletherapy physicist Paragraph 30 33 a 3 of 10 CFR Part 30 requires that an applicant be qualified by training and experience to use the requested radioactive materials for the purposes requested in such a manner as to protect health and minimize danger to life or property Subpart J of Part 35 provides specific criteria for acceptable training and experience for authorized users for medical use for the RSO and for the teletherapy physicist Note that curriculum vitae do not usually supply all the information needed to evaluate an individual s training and experience Authorized users involved in medical use have the following special responsibilities 1 Examination of patients and medical records to determine if a radiation procedure is appropriate http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 11 of 83 2 Prescription of the radiation dosage or dose and how it is to be administered 3 Actual use of or direction of technologists or other paramedical personnel in the use of byproduct material and 4 Interpretation of results of diagnostic procedures and evaluation of results of therapy procedures Numbers through 4 may be delegated to a physician who is under the supervision of an autho
28. 10 8 provides model rules for safe use of radiopharmaceuticals that can be used for radionuclide laboratories and Appendix J provides model spill procedures 7 POSTING AND CONTROLLING ACCESS TO PATIENT ROOMS See 10 CFR 20 1903 b When patients have received therapeutic administrations of radionuclides or therapeutic applications of sealed sources the criteria for exceptions to posting requirements specified in 10 CFR 20 1903 will likely be exceeded Dose rates from therapy patients can often exceed 5 mrem 50 uSv per hour at 1 meter from the patient Under these conditions the entrance to the patient s room must be posted and access to the area controlled Access can be controlled by routine surveillance and by posting instructions for hospital personnel and visitors at the entrance to the patient s room Examples of such instructions can be found in Exhibit 17 of this Regulatory Guide 10 8 Systems such as remote TV surveillance electronic eye or personnel entry detection devices are considered acceptable for monitoring personnel access to the patient s room Note that 10 CFR 20 1903 allows exceptions to the posting requirements if specific conditions are met Licensees should review 10 CFR 20 1902 and 1903 for posting requirements since some of the posting language has changed http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 80 of 83 8 EXEMPTIONS TO LABELING REQUIREMENTS See 10
29. 10 CFR Part 35 Federal Register Volume 51 No 200 Thursday October 16 1986 Rule and Regulations Title 10 Chapter 1 Code of Federal Regulations Energy Document Title Page No http www nrce gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 60 of 83 Click to View GIF File Commission Notices Policy Statements 10 CFR Parts 30 31 32 35 and 40 Medical Use of Byproduct Material APPENDIX T Considerations in Making Radiation Safety Program Changes See 35 31 The regulations allow the licensee to make changes that are not potentially important to safety in radiation safety procedures and in equipment When making changes it is the licensee s responsibility to ensure that the result will be in accord with the regulations and license conditions Any change must be reviewed for radiation safety considerations before it is approved http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 61 of 83 You should consider the following before making an application for a license amendment or making changes Not all the questions apply to all changes There may be other questions you should consider before making changes General 1 Proposed changes should be fully explained 2 Do not include unexplained acronyms abbreviations or undefined words 3 Spell out measurement units such as millicurie microcurie and millirem per
30. 12 Pergamon Press Elmsford NY 1969 11 International Commission on Radiation Units and Measurements ICRU Certification of Standardized Radioactive Sources Report No 12 Washington DC 1968 12 National Council on Radiation Protection and Measurements NCRP Precautions in the Management of Patients Who Have Received http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 72 of 83 Therapeutic Amounts of Radionuclides Report No 37 Washington DC 1970 12 NCRP Radiation Protection for Medical and Allied Health Personnel Report No 48 Washington DC 1976 12 NCRP Instrumentation and Monitoring Methods for Radiation Protection Report No 57 Washington DC 1978 12 NCRP A Handbook of Radioactivity Measurement Procedures Second Edition Report No 58 Washington DC 1985 12 NCRP Operational Radiation Safety Training Report No 71 Washington DC 1983 12 ANSI Standards 3 American National Standards Institute ANSI ANSI N13 2 1969 R1982 Administrative Practices in Radiation Monitoring A Guide for Management New York NY ANSI N13 4 1971 R1983 Specification of Portable X or Gamma Radiation Survey Instruments New York NY ANSI N13 5 1972 R1982 Performance and Specifications for Direct Reading and Indirect Reading Pocket Dosimeters for X and Gamma Radiation New York NY ANSI N13 6 1966 R1982 Practice for Occupational Radiation Exposure
31. C DATA The Regulatory Flexibility Act of 1980 requires Federal agencies to consider the effects of their rules on small businesses and other small entities In order for the NRC to maintain an up to date data base of its licensees four categories of economic information are sought from applicants This economic data will be used by the NRC in preparing regulatory analyses that contain among other things the anticipated economic burden a proposed rulemaking action will have on affected licensees To the extent that it is possible and consistent with public health and safety the NRC will consider the economic burden in light of the size of the entities affected by the rule in an attempt to mitigate the potential for a significant economic impact on a substantial number of small entities 14 a Annual Receipts Guidance for determining the approximate box in 14 a Annual Receipts 4 http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 18 of 83 1 Holders of One NRC License If your organization named on the license or application holds one NRC license and operates from one address check the box that most closely approximates your annual receipts in the case of hospitals academic institutions or other entities that do not operate on the basis of receipts check the box that most closely approximates the annual ope ra ting budget of your organization 2 Holders of Multiple NRC Licenses I
32. CFR 20 1905 Licensees are not required to label containers holding licensed material in quantities less than the quantities listed in Appendix C to ww 20 1001 20 2401 For iodine 125 carbon 14 and sulfur 35 the quantities below which labeling is not required are 1 uCi 1000 uCi and 100 uCi respectively In addition licensees are not required to label containers holding licensed material in concentrations less than those specified in Table 3 of Appendix B to 20 1001 20 2401 For iodine 125 carbon 14 and sulfur 35 the exemption concentrations are 2 x 10 uCi ml 3 x 10 wCi ml and 1 x 10 uCi ml respectively 9 PROCEDURES FOR RECEIVING AND OPENING PACKAGES See 10 CFR 20 1906 c and 20 1906 d In the revised Part 20 10 CFR 20 1906 modifies the Type A package quantity limits affecting package opening procedures monitoring required for radioactive contamination on external surfaces of a package and surface contamination levels requiring notification of the NRC as follows Special requirements must be followed for packages containing quantities of radioactive material in excess of the Type A quantity limits specified in 10 CFR 71 4 and Appendix A to Part 71 e g more than 20 curies of molybdenum 99 100 curies of technetium 99m 10 curies of iodine 131 cesium 137 or iridium 192 or more than 70 curies of iodine 125 All shipping packages received known to contain radioactive material must be monitored for radioactive contamination and
33. ING RESTRICTED AREAS e 8 1 Training Program e 8 2 Other Training Program Item 9 FACILITIES AND EQUIPMENT e 9 1 Annotated Drawing e 9 2 Survey Instrument Calibration e 9 3 Dose Calibrator Calibration e 9 4 Personnel Monitor Program e 9 5 Imaging Equipment e 9 6 Other Equipment and Facilities Item 10 RADIATION SAFETY PROGRAM e 10 1 Radiation Safety Committee Radiation Safety Officer e 10 2 ALARA Program e 10 3 Leak Test e 10 4 Safe Use of Radiopharmaceuticals e 10 5 Spill Procedures e 10 6 Ordering and Receiving e 10 7 Opening Packages e 10 8 Unit Dosage Records http www nrc gov NRC RG 10 10 008r2 htm1 Page 2 of 83 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 3 of 83 e 10 9 Multidose Vial Records e 10 10 Molybdenum Concentration Records e 10 11 Implant Source Use Records e 10 12 Area Survey Procedures e 10 13 Air Concentration Control e 10 14 Radiopharmaceutical Therapy e 10 15 Implant Therapy e 10 16 Other Safety Procedures e Item 11 WASTE MANAGEMENT e 11 1 Waste Disposal e 11 2 Other Waste Disposal e Item 12 LICENSE FEES e Item 13 CERTIFICATION e Item 14 VOLUNTARY ECONOMIC DATA e 14 a Annual Receipts e 14 b Number of Employees e 14 c Number of Beds Hospitals Only e 14 d Would You Be Willing To Furnish Cost Information on the Economic Impact of Current Regulations or any Future Proposed NRC Regulations That May Affect You
34. IX G Model Program for Maintaining Occupational Radiation Exposure at Medical Institutions ALARA See 35 20 You may use the text as it appears here saying on your application We will establish and implement the model ALARA program that was published in Appendix G to Regulatory Guide 10 8 Revision 2 If you prefer you may develop your own ALARA program for NRC review If you do so you should consider for inclusion all the features in the model and carefully review the requirements of 35 20 Say on your application We have developed an ALARA program for your review that is appended as ATT 10 2 and append your program ALARA PROGRAM Licensee s Name Date http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 32 of 83 1 Management Commitment a We the management of this medical facility hospital etc are committed to the program described herein for keeping individual and collective doses as low as is reasonably achievable ALARA In accord with this commitment we hereby describe an administrative organization for radiation safety and will develop the necessary written policy procedures and instructions to foster the ALARA concept within our institution The organization will include a Radiation Safety Committee RSC and a Radiation Safety Officer RSO We will perform a formal annual review of the radiation safety program including ALARA conside
35. MODEL PROCEDURES THAT APPLICANTS MAY USE TO PLAN RADIATION SAFETY PROGRAMS APPENDIX A Model Training Program See 9 12 and 35 21 http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 20 of 83 The following guidance may be used to develop a training program If you use the frequency and subject listings to develop your training program you may say on your application We will establish and implement the model training program that was published in Appendix A to Regulatory Guide 10 8 Revision 2 and have appended a table ATT 8 1 that identifies the groups of workers who will receive training and the method and frequency of training You may use lectures video taped presentations or demonstrations for example as methods of training If you prefer you may develop your own training program for review If you do so you should consider for inclusion all the features in the model program and carefully review the requirements of 19 12 Say on your application We have developed a training program for your review that is appended as ATT 8 1 Be sure to include the table that identifies groups of workers the method of their training and the frequency of training It may not be assumed that safety instruction has been adequately covered by prior occupational training board certification etc Site specific training should be provided for all workers Ancillary personnel e g nurs
36. Procedure Changes Why is the change needed What doses or dose rates apply to the individuals affected by the change For each step in the procedure what things are likely to go wrong either because of equipment failure or human error What are the likely consequences of problems noted in Question 3 What steps can be taken to mitigate the consequences noted in Question 4 OURA P TOTS APPENDIX U Recommended Support Equipment and Services Depending on the type of use and the size of the program you will need various types of equipment and services to support your radiation safety program The suggested list provided here does not include the many disposable or reusable items that are also necessary Also the list is not all inclusive and all items are not absolutely necessary Needs are divided to correspond to the subparts of Part 35 that describe different types of medical uses of byproduct material While instrumentation overlaps among subparts duplication is generally not necessary unless an instrument is to be dedicated to a single area of use or a single user Descriptions of some of the items follow the list Subpart D 1 Radiation detection survey meter On Dose calibrator 3 Constancy check source 4 Sealed sources for dose calibrator accuracy test 5 Constancy check source for uptake dilution and excretion equipment 6 Leak test service for sealed sources 7 Syringe shield 8 Personnel monitoring service 9 Su
37. R 11 2 Other Waste Disposal Submit waste disposal procedures that will be followed for radioactive materials described in Item 5 of this application other than material described in Part 35 Append them as ATT 11 2 If they are the same as the procedures submitted in Item 11 1 say See Item 11 1 Item 12 LICENSE FEES An application fee paid in full is required by paragraph 170 12 a of 10 CFR Part 170 for most types of licenses including applications for license amendments and renewals You should refer to 170 31 Schedule of Fees for Materials Licenses and Other Regulatory Services of 10 CFR Part 170 to determine the amount of the fee that must accompany your application An application received without a fee or with an inadequate fee may be returned to you All application fees may be charged irrespective of the NRC s disposition of the application or your withdrawal of the application Item 13 CERTIFICATION If the application is for a private practice it should be signed by a senior partner or the president If the application is for an institution hospital or medical center it must be signed by its director or chief executive officer Identify the title of the office held by the individual who signs the application BEFORE SUBMITTING IT REVIEW YOUR APPLICATION TO BE SURE YOU HAVE RESPONDED TO EACH ITEM AND TO BE SURE THAT EACH PAGE THAT YOU HAVE ATTACHED HAS AN ATTACHMENT NUMBER AND IS DATED Item 14 VOLUNTARY ECONOMI
38. Radioactive Spill Report see Exhibit 10 and the Radioactive Spill Contamination Survey see Exhibit 11 The following is not part of the model spill procedure Major Spills and Minor Spills The decision to implement a major spill procedure instead of a minor spill procedure depends on many incident specific variables such as the number of individuals affected other hazards present likelihood of spread of contamination and types of surfaces contaminated as well as the radiotoxicity of the spilled material For some spills of short lived radionuclides the best spill procedure may be restricted access pending complete decay Table J 1 which may be used as general guidance to determine whether a major spill procedure or a minor spill procedure should be implemented was developed based on a comparision of information from the following sources 1 Standards for Protection Against Radiation Proposed Rule Part 20 published January 9 1986 Appendix B Table 1 Column 3 Derived Air Concentration Values 51 FR 1092 2 Gamma Radiation Levels for One Curie of Some Radionuclides Radiological Health Handbook January 1970 edition Department of Health Education and Welfare Washington DC p 131 3 National Council on Radiation Protection and Measurements Safe Handling of Radioactive Materials NCRP Report No 30 http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio paragraph 2 3 a
39. Records Systems New York NY ANSI N14 5 1977 Leakage Tests on Packages for Shipment of Radioactive Materials New York NY ANSI N42 12 1980 R1985 Calibration and Usage of Sodium Iodide Detector Systems New York NY ANSI N42 13 1985 Calibration and Usage of Dose Calibrator Ionization Chambers for the Assay of Radionuclides New York NY Revision of ANSI N42 13 1978 ANSI N42 15 1980 R1985 Performance Verification of Liquid Scintillation Counting Systems New York NY ANSI N44 1 1973 R1984 Integrity and Test Specifications for Selected Brachytherapy Sources New York NY ANSI N44 2 1979 R1984 Leak Testing Radioactive Brachytherapy Sources New York NY ANSI N44 3 1973 R1984 Thyroid Radioiodine Uptake Measurements Using a Neck Phantom New York NY ANSI N323 1978 R1983 Radiation Protection Instrumentation Test and Calibration New York NY http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 73 of 83 ANSI N449 1974 R1984 Guidelines for Maintaining Cobalt 60 and Cesium 137 Teletherapy Equipment New York NY 1973 ANSI N449 1 1978 R1984 Procedures for Periodic Inspection of Cobalt 60 and Cesium 137 Teletherapy Equipment New York NY 1978 Other Resources Blatz Hanson Editor Radiation Hygiene Handbook McGraw Hill New York NY pp 22 27 1959 Cember Herman Introduction to Health Physics Second Edition Pergamon Pres
40. Regulatory Guide 10 8Guide for the Preparatio Page 1 of 83 Revision 2 August 1987 og o U S Nuclear Regulatory Commission R iow f Office of Nuclear Regulatory Research Regulatory Guide 10 8 Guide for the Preparation of Applications for Medical Use Programs Task FC 415 4 Division Index Regulatory Guide Index NRC Home Page Publication Information 1 INTRODUCTION e 1 1 GENERAL 1 1 1 Purpose of Guide 1 1 2 Purpose of Appendices to Guide 1 2 APPLICABLE REGULATIONS 1 3 AS LOW AS REASONABLY ACHIEVABLE ALARA PHILOSOPHY e 1 3 1 General ALARA Considerations 1 3 2 ALARA in Medical Institutions 1 4 TYPES OF LICENSES http www nrc gov NRC RG 10 10 008r2 htm1 11 24 99 Regulatory Guide 10 8Guide for the Preparatio e 1 4 1 General License e 1 4 2 Specific License e 1 4 3 Specific License of Broad Scope 2 FILING AN APPLICATION 3 CONTENTS OF APPLICATION Item 1 LICENSE INFORMATION Item 2 APPLICANT S NAME AND MAILING ADDRESS Item 3 LOCATIONS OF USE Item 4 PERSON TO BE CONTACTED ABOUT APPLICATION Item 5 RADIOACTIVE MATERIAL and Item 6 PURPOSE Item 7 INDIVIDUALS RESPONSIBLE FOR RADIATION SAFETY PROGRAMS THEIR TRAINING AND EXPERIENCE e 7 1 Authorized Users for Medical Use e 7 2 Authorized Users for Nonmedical Use e 7 3 Radiation Safety Officer e Items 8 through 11 Item 8 TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENT
41. Report Form Pencil Forms You may want to use Exhibit 10 Radioactive Spill Report and Exhibit 11 Radioactive Spill Contamination Survey Forms APPENDIX K Model Guidance for Ordering and Receiving Radioactive Material See 30 51 and 20 205 You may use the following guidance to control the ordering and receipt of radioactive material If you follow all the guidance you may say on your application We will establish and implement the model guidance for ordering and receiving radioactive material that was published in Appendix K to Regulatory Guide 10 8 Revision 2 If your procedure does not follow all the guidance in the model you may develop your own procedure for review If you do so you should consider for inclusion all the features in the model and carefully review the requirements of 30 51 and 20 205 Say on your application We have developed a procedure for ordering and receiving radioactive material for your review that is appended as ATT 10 6 and append your procedure for ordering and receiving radioactive material MODEL GUIDANCE 1 The Radiation Safety Officer RSO or a designee must authorize each order for radioactive materials and ensure that the requested materials and quantities are authorized by the license for use by the requesting authorized user and that possession limits are not exceeded 2 The RSO will establish and maintain a system for ordering and receiving radioactive material The system must
42. able to be distributed as particles more or less evenly throughout a medium such as a sewer system In practical terms biological material should be divided finely enough so as to mix readily with a water stream and continue to disperse rather than to reconcentrate This provision of the revised Part 20 allows continuation of the practice of discharging readily dispersible biological http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 81 of 83 materials such as ground up animal carcasses The prohibition of the discharge to sanitary sewer systems of nonbiological insoluble materials by w 20 2003 was designed to minimize the accumulation of insoluble material in the sewer system treatment plant and in sewage sludge Licensees should note that the monthly average concentrations of radionuclides allowed to be released to sanitary sewers under 10 CFR 20 2003 and Table 3 of Appendix B to ww 20 1001 20 2401 are generally 10 times more restrictive than the monthly average concentrations that have been allowed to be released into sanitary sewer systems under 10 CFR 20 303 c In addition the licensee should note that there are no longer daily concentration limits for release of material to the sanitary sewer as discussed in Appendix R to this Regulatory Guide 10 8 REGULATORY ANALYSIS A separate regulatory analysis was not prepared for this Appendix X to Regulatory Guide 10 8 The regulatory analysis
43. age 54 of 83 See 35 300 35 75 and 20 105 You may use the following procedure for reducing worker and public dose during radiopharmaceutical therapy If you will follow the model procedure you may say on your application We will establish and implement the model procedure for radiation safety during radiopharmaceutical therapy that was published in Appendix P to Regulatory Guide 10 8 Revision 2 If you prefer you may develop your own procedure for review If you do so you should consider for inclusion all the features in the model procedure and carefully review the requirements of 19 12 20 105 35 75 and 35 300 Say on your application We have developed a procedure for radiation safety during therapeutic use of radiopharmaceuticals for your review that is appended as ATT 10 14 and append your procedure MODEL PROCEDURE 1 The patient s room will be as far away from the nursing station and heavy traffic hallways as is consistent with good medical care It will be a private room with private sanitary facilities and should be without carpet 2 Prepare the room for the procedure as follows a Use leak proof absorbent paper to cover large surfaces the bed chairs and the floor around the toilet that are likely to be contaminated Small items telephone door knobs bed remote control television control and nurse call cord may be covered with absorbent paper or plastic bags b Prepare separate boxes for linen disposab
44. al internal as well as external doses to members of the general public from effluents to unrestricted areas Additional guidance is being developed on this and it will be addressed in a separate regulatory guide Licensees should establish ALARA goals or objectives for effluents In developing an ALARA radiation protection program licensees should design the program based on the size of the licensed facility the potential hazards associated with radiation exposure the potential intake of radioactive material and the physical characteristics of the radionuclides 1 e solid liquid or gas For example the magnitude of an ALARA program for a large research hospital would be expected to be considerably more comprehensive in scope than a radiation protection program for a private practice physician The program should include the mechanisms for periodic at least annually review of performance as well as actions to be taken when ALARA http www nrce gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 75 of 83 goals or objectives are not met The revised 10 CFR Part 20 does not require that a numerical cost benefit analysis quantitative approach be used to demonstrate ALARA However NRC encourages medical licensees to use quantitative analyses in developing ALARA programs and procedures If it can be performed readily licensees should demonstrate through quantitative analysis that the cost and benefits a
45. am of H 3 or C 14 may be disposed of without regard to its radioactivity 20 306 Make a record of the date radionuclide estimated activity in millicuries or microcuries calculated concentration in microcuries per gram and how the material was disposed of MODEL PROCEDURE FOR DISPOSAL BY DECAY IN STORAGE DIS Short lived material physical half life less than 65 days may be disposed of by DIS If you use this procedure keep material separated according to half life 1 Consider using separate containers for different types of waste e g capped needles and syringes in one container other injection paraphernalia such as swabs and gauze in another and unused dosages in a third container Smaller departments may find it easier to use just one container for all DIS waste Because the waste will be surveyed with all shielding removed the containers in which waste will be disposed of must not provide any radiation shielding for the material 2 When the container is full seal it with string or tape and attach an identification tag that includes the date sealed the longest lived radioisotope in the container and the initials of the person sealing the container The container may then be transferred to the DIS area 3 Decay the material for at least 10 half lives 4 Prior to disposal as in house waste monitor each container as follows a Check your radiation detection survey meter for proper operation b Plan to monitor in a low level l
46. ation We have developed a procedure for calculating spilled gas clearance times that is appended as ATT 10 13 4 and append your procedure 0 4 MODEL PROCEDURE FOR CALCULATING SPILLED GAS CLEARANCE TIME 1 Collect the following data a A the highest activity of gas in a single container in microcuries b Measured airflow supply from each vent in the room if different during heating and cooling seasons use the lesser value in milliliters per minute c Q the total room air exhaust determined by measuring in milliliters per minute the airflow to each exhaust vent in the room the exhaust should be vented and not recirculated within the facility this may be either the normal air exhaust or a specially installed gas exhaust system d C the maximum permissible air concentrations in restricted and unrestricted areas For Xe 133 the maximum permissible values are 1 x 10 Ci ml in restricted areas and 3 x 10 Ci ml in unrestricted areas For other gases see Appendix B to 10 CFR Part 20 and e V the volume of the room in milliliters 2 For each room make the following calculations a The airflow supply should be less than the airflow exhaust to ensure the room is at negative pressure ree V The evacuation time t Ea xin Cx V A APPENDIX P Model Procedure for Radiation Safety During Iodine Therapy Over 30 Millicuries http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio P
47. ation to you about the NRC staff s plans for using this regulatory guide and how these plans affect you The guide was distributed for comment to encourage public participation in its development Task FC 415 4 August 1985 This final Revision 2 represents the staff position of the NRC which incorporates the public comments that were received on the draft guide The draft guide and final guide differ If your license was issued or amended based on recommendations in the draft guide that are more restrictive than those in the final guide you may choose to request an amendment to your license to incorporate the less restrictive guidance In cases where the final guide is more restrictive than the draft guide licensing actions already completed will not be affected because all required regulatory findings have been made However the more restrictive recommendations in the final guide reflect items identified by the NRC staff as important to health and safety Discrepancies may be addressed for effective licenses by license amendment or rule change In unusual cases in which immediate action is required you would be contacted directly by the NRC The information in this regulatory guide is guidance not requirements The NRC reviews each application to ensure that users of byproduct material are capable of complying with NRC s regulations This guide provides one set of methods approved by the NRC for meeting the regulations APPENDICES Part 1
48. attachment is needed here 7 3 Radiation Safety Officer State the name and title of the person designated by and responsible to the applicant s management as RSO If the RSO is not one of the proposed authorized users submit a complete description of the individual s training and experience using Supplement A see Exhibit 2 The RSO should be a full time employee of the licensee Even if the licensee employs a consultant to assist the RSO the licensee is still responsible for the radiation safety program as required by the license Items 8 through 11 Your responses to these items should consist of one sentence that says that you will follow the model procedure in Appendix__ in Regulatory Guide 10 8 or that you have enclosed your procedure for review or simply the notation NA for not applicable Follow the instructions on the Applicability Table Table 2 to determine whether you must provide information or may simply respond NA to each item that follows Before you respond to an item read the introductory paragraphs of the referenced appendix Your short sentence or NA responses to Items 8 through 11 should run consecutively on one or more sheets Lengthy responses should be appended as attachments If you edit a model procedure solely to identify responsible individuals equipment by name or model room numbers or other site specific information there is no need to submit that procedure for review Table 2 APPLICABILITY TABLE T
49. cedures with byproduct material 2 FILING AN APPLICATION You should apply for a license by completing NRC Form 313 see Exhibit 1 You should complete Items 1 through 2 12 13 and 14 on the form itself For Items 5 through 11 submit the required information on supplementary pages You should identify and key each separate sheet or document submitted with the application to the items number of the application to which it refers All typed pages sketches and if possible drawings should be on 8 1 2 x 11 inch paper to facilitate handling and review If larger drawings are necessary fold them to 8 1 2 x 11 inches You should complete all items in the application in enough detail for the NRC to determine that your equipment facilities training and experience and radiation safety program are adequate to protect health and minimize danger to life and property Please note that license applications are available for review by the general public in the NRC Public Document Rooms Do not submit proprietary information unless absolutely necessary If submittal of such information is necessary follow the procedure in 2 790 of 10 CFR Part 2 Failure to follow this procedure may result in disclosure of the proprietary information to the public or substantial delays in processing your application Do not submit personal information about your individual employees unless it is necessary For example the training and experience of individuals should be
50. cement if the error exceeds 10 percent http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 24 of 83 4 Inspect the instrument on a quarterly basis to ascertain that the measurement chamber liner is in place and that the instrument is zeroed according to the manufacturer s instructions 5 Linearity means that the calibrator is able to indicate the correct activity over the range of use of that calibrator This test is done using a vial or syringe of Tc 99m whose activity is at least as large as the maximum activity normally assayed in a prepared radiopharmaceutical kit in a unit dosage syringe or in a radiopharmaceutical therapy whichever is largest Decay Method a Assay the Tc 99m syringe or vial in the dose calibrator and subtract background to obtain the net activity in millicuries Record the date time to the nearest minute and net activity on the Dose Calibrator Linearity Test Form see Exhibit 8 This first assay should be done in the morning at a regular time for example 8 a m b Repeat the assay at about noon and again at about 4 p m Continue on subsequent days until the assayed activity is less than 10 microcuries For dose calibrators on which you select a range with a switch select the range you would normally use for the measurement Convert the time and date information you recorded to hours elapsed since the first assay d On a sheet of semilog graph paper o
51. chair and taken immediately to the Nuclear Medicine Department Room Unlock the door place the package on top of the counter and relock the door If the package appears to be damaged immediately contact one of the individuals identified below Ask the carrier to remain at the hospital until it can be determined that neither the driver nor the delivery vehicle is contaminated If you have any questions concerning this memorandum please call our hospital Radiation Safety Officer at extension ___ Name Home Telephone Radiation Safety Officer Chief of Nuclear Medicine Chief Nuclear Medicine Technologist Nuclear Medicine Technologist on call call page operator at extension Nuclear Medicine Physician on call call page operator at extension z http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 43 of 83 APPENDIX L Model Procedure for Safely Opening Packages Containing Radioactive Material See 35 23 30 51 20 203 f 4 and 20 205 You may use the following model procedure for opening packages If you follow the model procedure you may say on your application We will establish and implement the model procedure for opening packages that was published in Appendix L to Regulatory Guide 10 8 Revision 2 If you develop your own package opening procedure for review you should consider for inclusion all the features in the model Say on your app
52. cked for radon leakage This can be done by submerging the source in a vial of fine grained charcoal or cotton for a day Then remove the source and analyze the adsorbent sample as described below A survey should be done to be sure the sources are adequately shielded during the leak test period 4 The samples will be analyzed as follows a Select an instrument that is sufficiently sensitive to detect 0 005 microcurie For beta sources a proportional flow counter liquid scintillation counter or thin end window GM survey meter may be appropriate For gamma sources a crystal with a ratemeter or scaler or a GM survey meter may be appropriate Dose calibrators used in nuclear medicine are not sufficiently sensitive b To estimate the detection efficiency of the analyzer used to assay the wipe samples assay a check source that has the same isotope as the sealed source and whose activity is certified by the supplier If one is not available it will be necessary to use a certified check source with a different isotope that has a similar spectrum If calculations demonstrate that the instrument is not sufficiently sensitive to detect 0 005 microcurie a different instrument must be used c Assay the wipe sample It must be in the same geometry relative to the detector as was the certified check source d Record the wipe sample counts per minute Then calculate and record the estimated activity in microcuries on the wipe sample e Continue the same anal
53. ction 31 11 of 10 CFR Part 31 General Domestic Licenses for Byproduct Material establishes a general license authorizing physicians veterinarians clinical laboratories and hospitals to receive acquire possess or use certain small quantities of byproduct material for in vitro clinical or laboratory tests not involving medical use that is not involving administration to humans Section 31 11 explains the requirements for using materials listed in that section If the general license alone meets the applicant s needs only Form NRC 483 Registration Certificate In Vitro Testing with Byproduct Material under General License need to be filed Medical use licensees do not need to file the form see paragraph 31 11 b If you need more than 200 microcuries of photon emitting 31 11 materials you may request an increased inventory limit as a separate line item on your NRC Form 313 application Licensees generally request 3 millicuries The use of materials listed in 31 11 within the inventory limits of that section will only be subject to the requirements of that section and not subject to the requirements of Parts 19 20 21 and 35 except as provided in 31 11 If you request an increased inventory limit you will be subject to the requirements of those parts including the requirements regarding waste disposal 1 4 2 Specific License Specific licenses for physicians in private practice are generally limited to physicians who are locate
54. ctions in Appendix E to this guide http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 66 of 83 A fume hood should have an adjustable sash It should be directly vented to the outside air The face velocity should be approximately 100 linear feet per minute with the sash at its normal location This should be measured with a velometer If one is not available hang a strip of tissue paper about 1 inch wide and 3 inches long from the bottom of the sash at the proper face velocity it will be gently deflected into the hood A teletherapy room monitor usually has a GM detector and either a scale labeled in mR hr or annunciator lights indicating when the source is on and off It must be installed so it can be easily seen when entering the teletherapy room A backup power supply must be provided When used by teletherapy technicians direct reading or indirect reading pocket dosimeters provide an immediate indication of personnel whole body exposure in case of an accidental exposure These should be calibrated using the source and procedure used for calibrating survey meters Personnel shields are used to shield workers from radioactive patients They may be mobile upright shields in the nuclear medicine clinic or a patient s room when a technician or nurse must stay beside a patient or they may be lead sheets used to shield transporters from patients in wheelchairs APPENDIX V Filing System
55. ctor survey meter Check the area around the spill Also check your hands clothing and http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 39 of 83 shoes for contamination 5 Report the incident to the Radiation Safety Officer RSO 6 The RSO will follow up on the cleanup of the spill and will complete the Radioactive Spill Report see Exhibit 10 and the Radioactive Spill Contamination Survey see Exhibit 11 Major Spills of Liquids and Solids 1 Clear the area Notify all persons not involved in the spill to vacate the room 2 Prevent the spread of contamination by covering the spill with absorbent paper but do not attempt to clean it up To prevent the spread of contamination limit the movement of all personnel who may be contaminated 3 Shield the source if possible This should be done only if it can be done without further contamination or a significant increase in radiation exposure 4 Close the room and lock or otherwise secure the area to prevent entry 5 Notify the RSO immediately 6 Decontaminate personnel by removing contaminated clothing and flushing contaminated skin with lukewarm water and then washing with mild soap If contamination remains induce perspiration by covering the area with plastic Then wash the affected area again to remove any contamination that was released by the perspiration 7 The RSO will supervise the cleanup of the spill and will complete the
56. cupational radiation exposures and Identify program problems and solutions Responsibilities The Committee shall l 2 8 9 Be familiar with all pertinent NRC regulations the license application the license and amendments Review the training and experience of the proposed authorized users the Radiation Safety Officer RSO and the teletherapy physicist to determine that their qualifications are sufficient to enable the individuals to perform their duties safely and are in accordance with the regulations and the license Review on the basis of safety and approve or deny consistent with the limitations of the regulations the license and the ALARA philosophy all requests for authorization to use radioactive material within the institution Prescribe special conditions that will be required during a proposed method of use of radioactive material such as requirements for bioassays physical examinations of users and special monitoring procedures Review quarterly the RSO s summary report of the occupational radiation exposure records of all personnel giving attention to individuals or groups of workers whose occupational exposure appears excessive Establish a program to ensure that all persons whose duties may require them to work in or frequent areas where radioactive materials are used e g nursing security housekeeping physical plant are appropriately instructed as required in 19 12 of 10 CFR Part 19 R
57. d audit the byproduct material program to ensure the continued safe use of byproduct material In addition to being a member of the Committee the RSO serves as a technical consultant to the Committee and is also responsible for the day to day operation of the radiation safety program A model ALARA management program is contained in Appendix G to this guide Several other NRC publications contain background information on the ALARA philosophy and its application in the medical envirohment For example Regulatory Guide 8 18 and NUREG 02 amp 7 Principles and Practices for Keeping Occupational Radiation Exposures at Medical Institutions As Low As Reasonably Achievable contain information methods and references useful in establishing radiation safety programs to maintain exposures ALARA is medical institutions Applicants should consider the ALARA philosophy in the development of plans for work with radioactive materials 1 4 TYPES OF LICENSES The NRC issues three types of licenses for the use of byproduct material in the practice of medicine They are described below This guide is only for persons who want to apply for a specific medical use license However persons who are applying for other types of licenses may find the information in this guide useful in designing their radiation safety program 1 4 1 General License http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 6 of 83 Se
58. d in private offices and not on hospital premises A Radiation Safety Committee is not required Methods of use that require hospitalization of the patient are not permitted Specific licenses are also issued to medical institutions A medical institution is an organization in which several medical disciplines are practiced These licenses authorize byproduct material for medical uses by physicians named on the institution s license The regulations in 35 22 of 10 CFR Part 35 require an institutional licensee to have a Radiation Safety Committee to oversee the use of licensed material throughout the institution and to review the institution s radiation safety program The physicians named on the institution s license conduct their programs with the approval of the Radiation Safety Committee A specific license may also be issued for a mobile nuclear medicine service see 35 29 of Part 35 Both private practitioners and institutions may apply for authorization to use byproduct material in a mobile service 1 4 3 Specific License of Broad Scope Some medical institutions provide patient care and conduct research programs that use radioisotopes for in vitro animal and medical procedures In these cases the NRC may issue a specific license of broad scope as discussed in 10 CFR Part 33 Specific Domestic Licenses of Broad Scope for Byproduct Material Specific licenses of broad scope for medical use i e licenses authorizing multiple quantities an
59. d sources Personnel monitoring service Survey meter calibration service Personnel shields SO MNAWKRWH Note If you are authorized for only a Sr 90 ophthalmic applicator only a storage safe or built in locked storage cabinet and leak test service are necessary Subpart H 1 Secure storage area 2 Leak test service for sealed sources 3 Radiation monitoring service for measuring dose rates from packages with replacement sources and decayed sources Subpart I 1 Radiation measurement or radiation detection survey meter 2s Room monitor 3 Patient viewing system 4 Leak test service 5 Calibrated dosimetry system 6 Spot check dosimetry system pe Direct reading pocket dosimeters 8 Personnel monitoring service 9 Teletherapy physicist service 10 Survey meter calibration service Descriptions A radiation detection survey meter usually has a GM tube or Nal T1 crystal detector The scale may be labeled in cpm or mR hr It is useful for detecting microcurie amounts of radioactivity and indicating approximate exposure levels If it is calibrated in mR hr the most sensitive scale will probably have a full scale deflection between 0 1 and 1 0 mR hr It can be used for measuring small amounts of http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 65 of 83 radioactivity if the user has measured its detection efficiency cpm dpm for the radionuclide being measured A
60. d types of byproduct material for unspecified uses are issued to institutions that 1 have had previous experience operating under a specific institutional license of limited scope and 2 are engaged in medical research as well as routine diagnosis and therapy using radioisotopes Such programs operate under the supervision of the Radiation Safety Committee A broad scope license allows the Radiation Safety http www nrce gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 7 of 83 Committee to review proposed methods of use and to permit individuals to use material under the provisions of the broad scope license An applicant for a broad scope license must show that appropriate personnel equipment and facilities are available Individual users are not named on the license nor are radioisotopes limited to specified uses Individual users and methods of use are authorized by the institution s Radiation Safety Committee This type of license is not appropriate for most institutions performing routine procedures with byproduct material Institutions may also apply for a broad scope license that combines features of the specific license and the specific license of broad scope discussed above It authorizes medical uses as described in Part 35 and authorizes the Committee to review and approve in vitro animal research uses This type of license is not appropriate for most institutions performing routine medical pro
61. dioactive source with a known amount of activity to convert sample measurements usually in counts per minute or cpm to disintegrations per minute or dpm 3 Immediately notify the RSO if you find unexpectedly high levels Records 1 Keep a record of dose rate and contamination survey results It must include the following information a The date area surveyed and equipment used b The name or initials of the person who made the survey c A drawing of the areas surveyed with contamination and dose rate action levels as established by the RSO Recommended removable surface contamination action levels are published in Regulatory Guide 8 23 Radiation Safety Surveys at Medical Institutions See Regulatory Guide 8 23 or Table N 1 below for guidance in establishing your action levels d Measured dose rates in mR hr or contamination levels in dpm 100 cm as appropriate e Actions taken in the case of excessive dose rates or contamination and followup survey information 2 The RSO will review and initial the record at least monthly and also promptly in those cases in which action levels were exceeded The following information is not part of the model procedure See Exhibit 16 for a sample record form Table N 1 Recommended Action Levels in dpm 100 cm for Surface Contamination by Radiopharmaceuticals P 32 Co 58 Fe 59 Co 60 Se 75 Sr 85 In 111 Cr 51 Co 57 Ga 67 123 I 125 I 131 Yb 169 Au 198 Tc 99m Hg 197 Tl 201
62. ed by the NBS Certified sources are available from the NBS and from many radioisotope suppliers At least two sources with different principal photon energies such as Co 57 Co 60 or Cs 137 should be used The regulations require that one must have a principal photon energy between 100 keV and 500 keV The regulations also require that if a Ra 226 source is used it must be at least 10 microcuries other sources must be at least 50 microcuries Consider using at least one reference source whose activity is within the range of activities normally assayed a Assay a calibrated reference source at the appropriate setting i e use the Co 57 setting to assay Co 57 and then remove the source and measure background Subtract background from the indicated activity to obtain the net activity Record this measurement on the Dose Calibrator Geometry and Accuracy Form see Exhibit 9 Repeat for a total of three determinations Average the three determinations The average value should be within 5 percent of the certified activity of the reference source mathematically corrected for decay Repeat the procedure for other calibrated reference sources If the average value does not agree within 5 percent with the certified value of the reference source the dose calibrator may need to be repaired or adjusted The regulation requires repair or replacement if the error exceeds 10 percent At the same time the accuracy test is done assay the source that wi
63. ee 35 75 35 404 and 35 406 You may use the following procedure to reduce worker and public dose during implant therapy If you will follow the model procedure you may say on your application We will establish and implement the model procedure for radiation safety during implant therapy that was published in Appendix Q to Regulatory Guide 10 8 Revision 2 http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 56 of 83 If you prefer you may develop your own procedure for review If you do so you should consider for inclusion all the features in the model procedure and carefully review the requirements of 19 12 20 105 35 75 35 404 and 35 406 Say on your application We have developed a procedure for radiation safety during implant therapy for your review that is appended as ATT 10 15 and append your procedure You may find a checklist to be helpful such as Exhibit 19 Radiation Safety Checklist for Temporary Implant Therapy MODEL PROCEDURE 1 The patient s room will be as far away from the nursing station and heavy traffic hallways as is consistent with good medical care It will be a private room unless the dose at one meter from the implant meets the requirements in paragraph 20 105 b of 10 CFR Part 20 2 Supply the nurses with film badges TLDs or pocket ionization chambers 3 Brief the nurses on radiation safety precautions Use the sample form Nursing Instruct
64. entory and use record for implant sources If you do so you should consider for inclusion all the features in the model system and carefully review the requirements of 30 51 35 21 and 35 406 Say on your application We have developed a procedure for keeping an inventory of implant sources for your review that is appended as ATT 10 11 and append your procedure for keeping an inventory and use record for implant sources MODEL PROCEDURE 1 Use a locking installed cabinet or safe to store all implant sources 2 Make a list of names of those individuals you allow to handle implant sources and have them initial beside their names 3 For long lived sources draw a map of the storage drawer and indicate the activity of the source at each storage point For short lived sources that you store in the manufacturer s shipping container indicate the area in the safe where you put the container Also be sure to add the sources to the inventory log 4 Post the map and the list of individuals whom you permit to handle the sources in the storage area or on the inventory log 5 Each time you remove a source make a record of the number and activity of sources removed the room number of use or patient s http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 48 of 83 name and the time and date they were removed from storage initial the record 6 Each time you return sources to storage immediately co
65. ernal and external dose and use of annual limits on intake ALIs and derived air concentrations DACs as a means for regulating the ingestion and inhalation of radionuclides The adoption of the effective dose concept and the application of the occupational dose limit to the sum of the internal and external doses change the methodology to be used for evaluating controlling and recording radiation doses In addition to the changes to the dose methodology there are other differences between the provisions of 10 CFR 20 1 20 601 and the provisions of 10 CFR 20 1001 20 2401 http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 74 of 83 Except in those cases in which an applicant proposes an acceptable alternative method for complying with specified portions of the Commission s regulations the methods described in this guide will be used in the evaluation of applications for new licenses or license renewals and for evaluating compliance with 10 CFR 20 1001 20 2401 Regulatory Guide 10 8 was prepared under the provisions of 10 CFR 20 1 20 601 and 10 CFR Part 35 This new appendix discusses the major differences introduced by the revised 10 CFR Part 20 that modify the guidance previously provided by the NRC for the conduct of medical use programs Any information collection activities mentioned in this appendix are contained as requirements in 10 CFR Part 20 which provides the regulatory basis for t
66. ert wipe sample counts per minute to disintegrations per minute Note that a dose calibrator is not sufficiently sensitive for this measurement Take precautions against the potential spread of contamination f Check the user request to ensure that the material received is the material that was ordered g Monitor the packing material and the empty packages for contamination with a radiation detection survey meter before discarding 1 If contaminated treat this material as radioactive waste 2 Ifnot contaminated remove or obliterate the radiation labels before discarding in in house trash h Make a record of the receipt 3 For packages received under the general license in 31 11 the following procedure for opening each package will be followed a Visually inspect the package for any sign of damage e g wet or crushed If damage is noted stop the procedure and notify the RSO b Check to ensure that the material received is the material that was ordered See Exhibit 12 for a sample record form you may want to use APPENDIX M Records of Byproduct Material Use General Many suppliers include pressure sensitive stickers or forms that have much of the information required by the regulations You may use these in your records and need not duplicate the information on them Be sure to write down whatever additional information is required but is not cued or printed on them Information does not have to be recorded in the order given i
67. es as indicated 0 1 0 2 0 3 0 4 0 5 0 6 0 7 0 8 0 9 0 10 0 11 Section 1 Committees Masters Personal Exposure Monitor Applications Exposure History Request Exposure History Report Teletherapy Monthly Check Nuclear Medicine Daily Survey Survey Meter Calibration Sink Disposal Logs Vented Release Logs Decay In Storage Release Records Room Survey Master Forms etc Each subsection of this section is devoted to a single committee In some cases the file will contain only meeting minutes In other cases the file may also include a committee charter curricula vitae of members and topical reports 1 1 1 2 1 3 1 4 1 5 Section 2 NRC License 2 1 22 2 3 2 4 2 3 2 6 2 7 http www nrc gov NRC RG 10 10 008r2 htm1 Radioactive Drug Research Committee Hospital Safety Committee Research Safety Committee Research Review Committee Radiation Safety Committee etc License Applications License Amendment Requests Amendments Photocopies of License Records of Minor Changes Inspection Reports and Replies Visiting Authorized User Credentials Misadministration Reports 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 68 of 83 2 8 Other Correspondence etc Section 3 Inventories Surveys and Waste 3 0 Inventory Summary Sheet 3 11 Nuclear Medicine Surveys and Inventory Summaries 3 12 Research Lab Surveys and Inventory Summaries 3 21 I Therapy Room Release Surveys 3 22 Brachytherap
68. escribed radionuclide chemical form and dosage before administering 15 Always keep flood sources syringes waste and other radioactive material in shielded containers 16 Because even sources with small amounts of radioactivity exhibit a high dose rate on contact you should use a cart or wheelchair to move flood sources waste and other radioactive material APPENDIX J Model Spill Procedures See 35 21 You may use the following model spill procedures as they appear here saying on your application We will establish and implement the model spill procedures published in Appendix J to Regulatory Guide 10 8 Revision 2 If you prefer you may develop your own spill procedures for review If you do so you should consider for inclusion all the items in the model procedures Say on your application We have developed spill procedures for your review that are appended as ATT 10 5 and append your spill procedures MODEL PROCEDURES Minor Spills of Liquids and Solids 1 Notify persons in the area that a spill has occurred 2 Prevent the spread of contamination by covering the spill with absorbent paper 3 Clean up the spill using disposable gloves and absorbent paper Carefully fold the absorbent paper with the clean side out and place in a plastic bag for transfer to a radioactive waste container Also put contaminated gloves and any other contaminated disposable material in the bag 4 Survey the area with a low range radiation dete
69. ess than 0 05 millirem per hour area c Remove any shielding from around the container d Monitor all surfaces of each individual container e Discard as in house waste only those containers that cannot be distinguished from background Record the date on which the container was sealed the disposal date and type of material e g paraphernalia unused dosages Check to be sure no radiation labels are visible f Containers that can be distinguished from background radiation levels must be returned to the storage area for further decay or transferred for burial 5 If possible Mo 99 Tc 99m generators should be held 60 days before being dismantled because of the occasional presence of a long lived contaminant When dismantling generators keep a radiation detection survey meter preferably with a speaker at the work area Dismantle the oldest generator first then work forward chronologically Hold each individual column in contact with the radiation detection survey meter in a low background less than 0 05 mR hr area Log the generator date and disposal date for your waste disposal records Remove or deface the radiation labels on the generator shield http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 59 of 83 MODEL PROCEDURE FOR TRANSFER FOR BURIAL Except for material suitable for DIS and some animal carcasses solids must be transferred to a burial site Follow the packaging inst
70. eview at least annually the RSO s summary report of the entire radiation safety program to determine that all activities are being conducted safely in accordance with NRC regulations and the conditions of the license and consistent with the ALARA program and philosophy The review must include an examination of records reports from the RSO results of NRC inspections written safety procedures and the adequacy of the management control system Recommend remedial action to correct any deficiencies identified in the radiation safety program Maintain written minutes of all Committee meetings including members in attendance and members absent discussions actions recommendations decisions and numerical results of all votes taken and 10 Ensure that the byproduct material license is amended if required prior to any changes in facilities equipment policies procedures and personnel Administrative Information 1 The Committee shall meet as often as necessary to conduct its business but not less than once in each calendar quarter 2 Membership must include one authorized user for each type of use authorized by the license the RSO a representative of the nursing 3 service and a representative of management who is neither an authorized user nor an RSO Management may appoint alternate members to participate in meetings in the case of absence of principal members and should consider appointing as adjunct members representatives f
71. f the http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 46 of 83 1 Radionuclide 2 Generic name or its abbreviation or trade name 3 Date of receipt or preparation 4 Date and time of initial assay and amount in both millicuries and cubic centimeters cc or milliliters ml 5 Supplier or kit manufacturer 6 If administered a Prescribed dosage unless already recorded in clinical procedure manual b Date and time dosage was drawn and measured c Calculated volume that is needed for the prescribed dosage d Measured activity in millicuries or microcuries e Patient name and identification number if one has been assigned 7 If discarded the method of disposal and date and 8 Initials of the individual who made the record See Exhibit 14 for a Multidose Vial Preparation and Use Log Form you may want to use M 3 Measuring and Recording Molybdenum Concentration 35 204 The regulations require that each licensee who uses a technetium generator to prepare radiopharmaceuticals must test each elution or extraction for its molybdenum concentration This does not have to be done when using radiopharmaceuticals obtained from a distributor This measurement is usually made with a dose calibrator Licensees may not administer radiopharmaceuticals that contain more than 0 15 microcurie of Mo 99 per millicurie of Tc 99m at the time of administration If an elution or extraction has
72. for the Investigational Level I Personnel dose equal to or greater than Investigational Level I but less than Investigational Level II The RSO will review the dose of each individual whose quarterly dose equals or exceeds Investigational Level I and will report the results of the reviews at the first RSC meeting following the quarter when the dose was recorded If the dose does not equal or exceed Investigational Level II no action related specifically to the exposure is required unless deemed appropriate by the Committee The Committee will however review each such dose in comparison with those of others performing similar tasks as an index of ALARA program quality and will record the review in the Committee minutes Personnel dose equal to or greater than Investigational Level II http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 35 of 83 The RSO will investigate in a timely manner the causes of all personnel doses equaling or exceeding Investigational Level II and if warranted will take action A report of the investigation any actions taken and a copy of the individual s Form NRC 5 or its equivalent will be presented to the RSC at its first meeting following completion of the investigation The details of these reports will be included in the RSC minutes d Reestablishment of investigational levels to levels above those listed in Table 1 In cases where a worker s or a group of worke
73. g personnel monitoring records film TLD etc If necessary modify the dose to account for an anticipated increase or decrease in patient workload 2 Modify the DAC value for xenon 133 to allow for the estimated annual external exposure A simplified method is to subtract the estimated external dose from the occupational dose limit of 5 rems 50 mSv and divide this number by 5 rems This yields the fraction of the dose limit of 5 rems that would still be permitted from internal sources Multiplying this fraction times the DAC value yields a modified DAC These DAC values are provided in Appendix B to 10 CFR ww 20 1001 20 2401 in Table 1 Column 3 The annual external dose is 2 rems The listed DAC value for xenon 133 is 1E 4 uCi ml The modified DAC value should be based on 3 rems that could still be incurred from internal exposure http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 77 of 83 5 rems 3rems 3 Calculate the minimum ventilation rates for the room using the procedure provided in Appendix O to this Regulatory Guide 10 8 In place of the MPC value stipulated in Appendix O use the modified DAC value In the example provided above the modified DAC value 6E 5 uCi ml would be used instead of the MPC value for xenon 133 DAC modified x lE 4m Gi ml 6E 5Ci ml The discussion and example presented in this section do not specifically address ALARA and the monitorin
74. g thresholds for internal doses as it relates to the summation of internal and external dose However it should be noted that modifications to ventilation rates can be a means to maintaining exposures ALARA In addition increased ventilation rates may negate the requirement to monitor internal dose and as such may eliminate the necessity to sum internal and external dose to show compliance with the occupational dose limits 2 2 Occupational Dose Limits In 10 CFR 20 101 the quarterly occupational dose limit of 1 25 rems 5 rems in a year applies only to whole body exposures to external radiation 10 CFR 20 101 If the licensee has a dose history and a worker s cumulative dose is less than 5 age 18 rems the worker could be allowed under certain circumstances to receive occupational exposure in excess of the 10 CFR 20 101 a limit up to 3 rems per quarter 10 CFR 20 102 b In addition to the 5 rem annual total for occupational external exposure 10 CFR 20 103 specifies a separate limit to apply to exposures to concentrations of radioactive materials in air in restricted areas 10 CFR 20 103 and Column 1 Table 1 of Appendix B to ww 20 1 20 601 The revised Part 20 applies the 5 rem 50 mSv occupational dose limit as a whole body effective dose This limit is the sum of the deep dose equivalent from external sources and the committed effective dose equivalent to the organs exposed from the internal uptake of radionuclides expressed as the tota
75. grams to those programs developed for radiation safety equipment However when delicate imaging equipment is transported from one location of use to another e g by a mobile nuclear medicine service it is reasonable to assume that it may suffer damage in transit Therefore the NRC requires that mobile nuclear medicine services have an imaging equipment quality assurance program to ensure that the use of byproduct material will not be inimical to the public health and safety Mobile nuclear medicine services should also check ventilation equipment if gases or aerosols will be used You may use the following procedure to ensure the proper operation of imaging equipment that has been transported If you follow the procedure you may say on your application We will establish and implement the model procedure for ensuring equipment performance that was published in Appendix E to Regulatory Guide 10 8 Revision 2 If you want to develop your own procedure for review you should consider for inclusion all the features in the model procedure and the procedure recommended by the manufacturer and carefully review the requirements of 35 29 and 35 80 Say on your application We have developed a procedure for ensuring equipment performance for your review that is appended as ATT 9 5 and append your imaging equipment quality assurance procedure MODEL PROCEDURE Survey Meter Check the survey meter with the dedicated check source at each location of
76. he application describe the intended use and the facilities and equipment at each location If you are applying for a license for a mobile nuclear medicine service specify so and list the name and location of each client Item 4 PERSON TO BE CONTACTED ABOUT APPLICATION You should provide the name and telephone number of the individual who knows your proposed radioactive materials program and can answer questions about the application This individual usually the RSO or a principal user of radioactive materials will serve as the point of contact during the review of the application and during the period of the license If this individual is not your full time paid employee specify your relationship with this individual Notify the NRC if the individual assigned to this function changes Notification of a contact change is for information only and would not be considered an application for a license amendment Item 5 RADIOACTIVE MATERIAL and Item 6 PURPOSE http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 10 of 83 Part 35 divides byproduct material for medical use into six types of use Using the table format of Table 1 as a guide you may indicate only the types of use you want and the maximum amount You may say As needed in the Amount column as shown For 35 400 implant material express the total amount in millicuries mCi If you plant to have an eye applicator list it as
77. his guide The information collection requirements in 10 CFR Part 20 have been cleared under OMB Clearance No 3150 0014 The following are the major areas of medical use programs affected by the revised Part 20 1 RADIATION PROTECTION PROGRAMS See Appendix G to Regulatory Guide 10 8 In the revised Part 20 10 CFR 20 1101 requires each licensee to develop document and implement a radiation protection program appropriate to the scope and extent of the activities conducted and to review at least annually the program content and its implementation Further 10 CFR 20 1101 requires that each licensee use engineering controls and procedures to ensure that occupational doses and doses to members of the public are as low as is reasonably achievable ALARA In addition 10 CFR 20 2102 provides the recordkeeping requirements for radiation protection programs The requirements in 10 CFR 20 1101 are consistent with the requirements for control of occupational exposures in 10 CFR Parts 33 and 35 Radiation protection programs that have been established under the requirements of 10 CFR Parts 33 and 35 will be considered to be acceptable to meet the occupational ALARA requirements of the revised 10 CFR Part 20 when the program activities are limited to external occupational exposures However licensees who handle unsealed radioactive materials that may cause internal exposure to members of the public will need to supplement their ALARA programs to address potenti
78. his procedure does not apply to backup monitor records for example pocket ionization chambers when the monitor of record is a film or thermoluminescence dosimeter TLD 2 All individuals who are occupationally exposed to ionizing photon radiation on a regular basis will be issued a film or TLD whole body monitor that will be processed by a contract service on a monthly basis 3 All individuals who on a regular basis handle radioactive material that emits ionizing photons will be issued a film or TLD finger monitor that will be processed by a contract service on a monthly basis 4 All individuals who are occupationally exposed to radiation on an occasional basis such as nurses caring for radiopharmaceutical therapy or implant patients will be issued a whole body monitor when caring for such patients 5 Other individuals who are exposed to radiation on an occasional basis such as security personnel who deliver packages secretarial personnel who work in the nuclear medicine clinic but do not work with patients and nurses who occasionally care for patients who have received diagnostic dosages will not normally be issued exposure monitors APPENDIX E Model Procedure for Checking Equipment Used in Mobile Nuclear Medicine Service See 35 29 and 35 80 http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 28 of 83 The NRC normally limits its review of equipment quality assurance pro
79. ials 3 Either after each procedure or before leaving the area monitor your hands for contamination in a low background area with a crystal probe or camera 4 Use syringe shields for routine preparation of multi dose vials and administration of radiopharmaceuticals to patients except in those circumstances in which their use is contraindicated e g recessed veins infants In these exceptional cases consider the use of other protective methods such as remote delivery of the dose e g through use of a butterfly valve 5 Do not eat drink smoke or apply cosmetics in any area where radioactive material is stored or used 6 Do not store food drink or personal effects in areas where radioactive material is stored or used 7 Wear personnel monitoring devices at all times while in areas where radioactive materials are used or stored These devices should be worn as prescribed by the Radiation Safety Officer When not being worn to monitor occupational exposures personnel monitoring devices should be stored in the work place in a designated low background area 8 Wear a finger exposure monitor during the elution of generators during the preparation assay and injection of radiopharmaceuticals and when holding patients during procedures 9 Dispose of radioactive waste only in designated labeled and properly shielded receptacles 10 Never pipette by mouth 11 Wipe test byproduct material storage preparation and administration areas
80. ing clerical housekeeping security whose duties may require them to work in the vicinity of radioactive material whether escorted or not need to be informed about radiation hazards and appropriate precautions All training should be tailored to meet the needs of the individuals in attendance A training program that provides necessary instruction should be written and implemented MODEL PROGRAM Personnel will be instructed 1 Before assuming duties with or in the vicinity of radioactive materials 2 During annual refresher training 3 Whenever there is a significant change in duties regulations or the terms of the license Instruction for individuals in attendance will include the following subjects Applicable regulations and license conditions Areas where radioactive material is used or stored Potential hazards associated with radioactive material in each area where the employees will work Appropriate radiation safety procedures Licensee s in house work rules Each individual s obligation to report unsafe conditions to the Radiation Safety Officer Appropriate response to emergencies or unsafe conditions Worker s right to be informed of occupational radiation exposure and bioassay results Locations where the licensee has posted or made available notices copies of pertinent regulations and copies of pertinent licenses and license conditions including applications and applicable correspondence as re
81. ion 5 percent d Accuracy at installation and at least annually thereafter 5 percent 2 After repair adjustment or relocation of the dose calibrator repeat the above tests as appropriate 3 Constancy means reproducibility in measuring a constant source over a long period of time Assay at least one relatively long lived source such as Cs 137 Co 60 Co 57 2 or Ra 226 2 using a reproducible geometry each day before using the calibrator Consider the use of two or more sources with different photon energies and activities Use the following procedure a Assay each reference source using the appropriate dose calibrator setting i e use the Cs 137 setting to assay Cs 137 b Measure background at the same setting and subtract or confirm the proper operation of the automatic background subtract circuit if it is used c For each source used either plot on graph paper or log in a book the background level for each setting checked and the net activity of each constancy source Using one of the sources repeat the above procedure for all commonly used radioisotope settings Plot or log the results e Establish an action level or tolerance for each recorded measurement at which the individual performing the test will automatically notify the chief technician or authorized user of suspected malfunction of the calibrator These action levels should be written in the log book or posted on the calibrator The regulation requires repair or repla
82. ion We have developed a procedure for waste disposal for your review that is appended as ATT 11 1 and attach your procedure Overview There are four commonly used methods of waste disposal release to the environment through the sanitary sewer or by evaporative release decay in storage DIS transfer to a burial site or back to the manufacturer and release to in house waste With the exception of the patient excreta see paragraph 20 303 d and generally licensed in vitro kit exemptions see paragraph 31 11 f nothing in these guidelines relieves the licensee from maintaining records of the disposal of licensed material See paragraphs 30 51 a and 20 401 c 3 General Guidance 1 All radioactivity labels must be defaced or removed from containers and packages prior to disposal in in house waste If waste is compacted all labels that are visible in the compacted mass must be defaced or removed 2 Remind employees that nonradioactive waste such as leftover reagents boxes and packing material should not be mixed with radioactive waste 3 Occasionally monitor all procedures to ensure that radioactive waste is not created unnecessarily Review all new procedures to ensure that waste is handled in a manner consistent with established procedures 4 In all cases consider the entire impact of various available disposal routes Consider occupational and public exposure to radiation other hazards associated with the material and routes of dis
83. ions for Patients Treated With Temporary Implant Sources Exhibit 20 or your own nursing instruction form as an outline Allow time for questions and answers during the briefing 4 Brief the patient on radiation safety procedures for confinement to bed visitor control and other items as applicable consistent with good medical care 5 Only those persons needed for medical safety or training purposes should be present during the implant procedure 6 Mark a visitors safe line on the floor with tape as far from the patient as possible 7 Following the implant measure the exposure rate in mR hr at bedside at 1 meter from bedside at the visitors safe line and in the surrounding hallways and rooms the last rates must conform to requirements in paragraph 20 105 b Record this and any other necessary information on the nursing instruction form or the nurses dosimeter signout form Post the room with a Radioactive Materials sign 8 Do not release any patient who has received a temporary implant from the hospital until both a radiation survey of the patient and a count of implant sources trains or ribbons confirms that all sources have been removed from the patient and are accounted for Perform this check immediately after the removal of the sources Keep a record confirming the source count and radiation survey on the implant source running inventory form For low activity seeds less than 1 millicurie use an individual seed to check the
84. ive waste storage film processor toilet closet hallway 4 Any shielding available 5 Additional safety equipment for example fume hoods L blocks or fixed area monitors See Exhibit 6 for an example 9 2 Survey Instrument Calibration Submit your procedure for calibrating survey instruments See Appendix B 9 3 Dose Calibrator Calibration Submit your procedure for calibrating the dose calibrator See Appendix C 9 4 Personnel Monitor Program Describe your personnel occupational exposure monitor program See Appendix D of this guide 9 5 Imaging Equipment If you are transporting imaging equipment as part of a mobile nuclear medicine service describe your procedure for checking the equipment to ensure it has not been damaged in transit See Appendix E If you are not going to provide mobile nuclear medicine service say NA 9 6 Other Equipment and Facilities Describe other equipment and facilities available for the use and storage of material described in Item 5 of this application other than material described in Part 35 Append it as ATT 9 6 http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 15 of 83 Item 10 RADIATION SAFETY PROGRAM 10 1 Radiation Safety Committee Radiation Safety Officer Describe your Radiation Safety Committee Charter and Radiation Safety Officer delegation of authority A Radiation Safety Committee must be established by each medical in
85. ix M 2 10 10 Molybdenum Concentration Records Submit your procedure for measuring and recording molybdenum concentration See Appendix M 3 10 11 Implant Source Use Records Submit your procedure for keeping an inventory of implant sources See Appendix M 4 10 12 Area Survey Procedures Submit your area survey procedures See Appendix N 10 13 Air Concentration Control 1 Submit your procedure for estimating worker dose from submersion in noble gases See Appendix 0 2 Submit your procedure for estimating worker dose from aerosol concentrations See Appendix 0 3 Submit your procedure for estimating aerosol and gas concentration in effluents See Appendix 0 4 Submit your procedure for calculating spilled gas clearance tim es See Appendix 0 10 14 Radiopharmaceutical Therapy Submit your procedure for radiation safety during radiopharmaceutical therapy See Appendix P 10 15 Implant Therapy Submit your procedure for radiation safety during implant therapy See Appendix Q 10 16 Other Safety Procedures Submit safety procedures that will be followed by individuals who handle radioactive material described in Item 5 of this application other than material described in Part 35 Append them as ATT 10 16 Item 11 WASTE MANAGEMENT http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 17 of 83 11 1 Waste Disposal Submit your procedures for waste disposal See Appendix
86. l Applicability to Domestic Licensing of Byproduct Material 10 CFR Part 71 Packaging and Transportation of Radioactive Material and 10 CFR Part 170 Fees for Facilities and Materials Licenses and Other Regulatory Services Under the Atomic Energy Act of 1954 as Amended This regulatory guide identifies the information needed to complete NRC Form 313 when applying for a license for a medical use program The information collection requirements in NRC Form 313 have been cleared under OBM Clearance No 3150 0120 1 3 AS LOW AS REASONABLY ACHIEVABLE ALARA PHILOSOPHY Paragraph 20 1 c of 10 CFR Part 20 states persons engaged in activities under licenses issued by the Nuclear Regulatory Commission pursuant to the Atomic Energy Act of 1954 as amended and the Energy Reorganization Act of 1974 should in addition to complying with the requirements set forth in this part make every reasonable effort to maintain radiation exposures and releases of radioactive materials in effluents to unrestricted areas as low as is reasonably achievable Regulatory Guides 8 10 Operating Philosophy for Maintaining Occupational Radiation Exposures As Low As Is Reasonably Achievable and 8 18 Information Relevant to Ensuring That Occupational http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 5 of 83 Radiation Exposures at Medical Institutions Will Be As Low As Reasonably Achievable provide the NRC
87. l effective dose equivalent 10 CFR 20 1201 Additional guidance is provided in Regulatory Guide 8 34 Monitoring Criteria and Methods To Calculate Occupational Doses on the methods to be used for determining these dose equivalents Revision 1 of Regulatory Guide 8 7 Instructions for Recording and Reporting Occupational Radiation Exposure Data provides guidance on reporting the dose data on NRC Forms 4 and 5 The revised Part 20 no longer contains provisions for an age proration 5 N 18 2 3 Effective Dose Equivalent The effective dose equivalent concept described above makes it possible to combine both the internal and external doses in assessing the overall risk of health effects to an individual Prior to the revision of Part 20 the activity concentration limits for intakes of a single radionuclide in Appendix B to ww 20 1 20 601 were based on controlling the dose to the organ receiving the highest dose critical organ These concentration limits however were treated separately from the dose limits for external exposure The revised 10 CFR Part 20 dose methodology evaluates the doses to all major body organs multiplies these doses by the appropriate organ weighting factors and then sums the organ weighted doses to obtain a whole body risk weighted effective dose The ALIs and DACs in Appendix B to ww 20 1001 20 2401 therefore reflect the doses to all principal organs that are irradiated not just the one organ that receives the highe
88. l regulations Separate guidance is being developed to meet the specific needs of a teletherapy applicant Draft Regulatory Guide FC 414 4 Guide for the Preparation of Applications for Licenses for Medical Teletherapy Programs has been issued for public comment This guide does not apply to academic programs that do not use byproduct material for medical use 1 1 2 Purpose of Appendices to Guide The regulations require that the licensee develop and implement procedures that will ensure compliance with the regulations Appendices A through R to this guide describe model radiation safety procedures Each applicant should carefully read the applicable regulations and model procedures and then decide if the model procedures are appropriate for its specific radiation safety needs In the application applicants may certify that they will follow model procedure appropriate certification language is given at the beginning of each appendix or may say that they have developed a procedure that is enclosed for review appropriate reference language is given at the beginning of each appendix 1 2 APPLICABLE REGULATIONS In addition to 10 CFR Part 35 other regulations pertaining to the medical use of byproduct material are found in 10 CFR Part 19 Notices Instructions and Reports to Workers Inspections 10 CFR Part 20 Standards for Protection Against Radiation 10 CFR Part 21 Reporting of Defects and Noncompliance 10 CFR Part 30 Rules of Genera
89. le waste and nondisposable contaminated items Place a single large reclosable plastic bag in each box or supply several small plastic bags c Determine whether urine will be discarded by release to the sanitary sewer or collected If urine will be collected prepare collection containers 1 Containers should be unbreakable and closable 2 If there is no need for assay or volumetric determination and urine will be decayed in storage add to each container an absorbent such as vermiculite 3 To avoid room contamination in the case of a spill place containers in a box or deep tray that has been lined with a plastic bag and absorbent paper or vermiculite 4 Supply a few half value layers of shielding for each container For I 131 one half value layer is approximately 3 mm of lead 5 Supply a wide mouth antisplash funnel d Stock additional disposable gloves absorbent paper and radioactive waste labels in the room for use as necessary by nursing nuclear medicine and radiation safety personnel 3 Order disposable table service for the duration of the patient s stay Inform the Housekeeping Office that personnel should stay out of the room until otherwise notified 4 Supply the nurses with film badges TLDs or pocket ionization chambers 5 Brief the nurses on radiation safety precautions Use the sample form Nursing Instructions for Patients Treated with Iodine 131 http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regula
90. lication We have developed a package opening procedure for your review that is appended as ATT 10 7 and append your package opening procedure MODEL PROCEDURE 1 Special requirements must be followed for packages containing quantities of radioactive material in excess of the Type A quantity limits specified in paragraph 20 205 b of 10 CFR Part 20 e g more than 20 curies of Mo 99 Tc 99m uncompressed Xe 133 or more than 3 curies of Xe 133 I 131 Cs 137 Ir 192 I 125 or more than 0 001 curie of Ra 226 Such packages must be monitored for external radiation levels and surface contamination within 3 hours after receipt if received during working hours or within 18 hours if received after working hours in accordance with the requirements of paragraphs 20 205 a through c The NRC Regional Office must be notified if removable contamination exceeds 0 01 microcurie 22 000 dpm 100 cm 2 For packages received under the specific license the following procedure for opening each package will be followed a Put on gloves to prevent hand contamination b Visually inspect the package for any sign of damage e g wet or crushed If damage is noted stop the procedure and notify the Radiation Safety Officer RSO c Measure the exposure rate from the package at 1 meter and at the package surface If it is higher than expected stop and notify the RSO The transport index noted on packages with Yellow II or Yellow III labels is the approxi
91. ll be used for the daily constancy test it need not be a certified reference source on all commonly used radioisotope settings Record the settings and indicated millicurie values with the accuracy data http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 27 of 83 f Put a sticker on the dose calibrator that says when the next accuracy test is due 8 The RSO will review and sign the records of all geometry linearity and accuracy tests See Exhibits 8 and 9 for some forms you may want to use APPENDIX D Model Personnel External Exposure Monitoring Program See 20 101 You may use the following model program to monitor personnel external exposure If you follow the guidance in the program you may say on your application We will establish and implement the model personnel external exposure monitoring program published in Appendix D to Regulatory Guide 10 8 Revision 2 If you prefer you may develop your own program for review If you do you should consider for inclusion all the features in the model program and carefully review the requirements of 20 101 Say on your application We have developed an external exposure monitoring program for your review that is appended as ATT 9 4 and append your monitoring program MODEL PROGRAM 1 The RSO will promptly review all exposure reports to look for workers or groups of workers whose exposure is unexpectedly high or low T
92. maintain exposure ALARA 2 When considering a new use of byproduct material the RSC will review the efforts of the applicant to maintain exposure ALARA 3 The RSC will ensure that the users justify their procedures and that individual and collective doses will be ALARA Delegation of Authority The judicious delegation of RSC authority is essential to the enforcement of an ALARA program 1 The RSC will delegate authority to the RSO for enforcement of the ALARA concept 2 The RSC will support the RSO when it is necessary for the RSO to assert authority If the RSC has overruled the RSO it will record the basis for its action in the minutes of the quarterly meeting Review of ALARA Program 1 The RSC will encourage all users to review current procedures and develop new procedures as appropriate to http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 33 of 83 implement the ALARA concept 2 The RSC will perform a quarterly review of occupational radiation exposure with particular attention to instances in which the investigational levels in Table 1 are exceeded The principal purpose of this review is to assess trends in occupational exposure as an index of the ALARA program quality and to decide if action is warranted when investigational levels are exceeded see Section 6 below for a discussion of investigational levels 3 The RSC will evaluate our institution s overall effo
93. mate dose rate in millirem per hour at 1 meter from the package surface see 71 4 of 10 CFR Part 71 the surface dose rate for such packages should not exceed 200 millirem per hour The dose rate from packages with White I labels should be less than 0 5 millirem per hour at the package surface See 172 403 of 49 CFR Part 172 d Open the package with the following precautionary steps 1 Remove the packing slip 2 Open the outer package following the supplier s instructions if provided 3 Open the inner package and verify that the contents agree with the packing slip 4 Check the integrity of the final source container Look for broken seals or vials loss of liquid condensation or discoloration of the packing material 5 If anything is other than expected stop and notify the RSO http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 44 of 83 e If there is any reason to suspect contamination wipe the external surface of the final source container and remove the wipe sample to a low background area Assay the wipe sample to determine if there is any removable radioactivity The licensee should specify in the procedure manual which instrument for example a thin end window GM survey meter a Nal T1 crystal and ratemeter a liquid scintillation counter or a proportional flow counter should be used for these assays The detection efficiency must be determined to conv
94. me 20 percent loss Measured airflow supplied by each vent in the imaging room if different during heating and cooling seasons use the lesser value Measured airflow exhausted by each vent in the imaging room the exhaust should be vented and not recirculated within the facility Measured airflow exhaust at the storage site e g a fume hood and Maximum permissible air concentrations in restricted and unrestricted areas For Xe 133 the maximum permissible values are 1 x 10 Ci ml in restricted areas and 3 x 10 Ci ml in unrestricted areas For soluble Tc 99m the maximum permissible values are 4 x 10 Ci ml in restricted areas and 1 x 10 Ci ml in unrestricted areas For other gases or aerosols see Appendix B to 10 CFR Part 20 2 The following calculations must be made a The sum of all measured exhaust rates and the sum of all measured supply rates If the former is larger than the latter this ensures that the imaging room is at negative pressure b The estimated average concentration in restricted areas 1 The total activity released to the restricted area activity used each week multiplied by estimated fractional loss per study divided by the total air exhausted sum of all exhaust rates multiplied by the length of the work week must be less than the applicable maximum permissible value for a restricted area 2 If this is not the case plan for fewer studies An increase in the ventilation rate will not significantl
95. ml 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 22 of 83 on each decade and at no less than two points on one of the decades Those points should be at approximately 1 3 and 2 3 of the decade 9 Readings above 1 000 mR hr need not be calibrated However such scales should be checked for operation and approximately correct response 10 At the time of calibration the apparent exposure rate from a built in or owner supplied check source must be determined and recorded 11 The report of a survey meter calibration should indicate the procedure used and the data obtained The description of the calibration will include a b g h i The owner or user of the instrument A description of the instrument that includes manufacturer model number serial number and type of detector A description of the calibration source including exposure rate at a specified distance on a specified date and the calibration procedure For each calibration point the calculated exposure rate the indicated exposure rate the deduced correction factor the calculated exposure rate divided by the indicated exposure rate and the scale selected on the instrument The reading indicated with the instrument in the battery check mode if available on the instrument The angle between the radiation flux field and the detector for external cylindrical GM or ionization type detectors this will usually be parallel or pe
96. n these procedures Also you do not have to replicate entries For example if you prepare a multidose vial for use one day you do not have to record the date each time you draw a dosage from it if you take 30 Ir 192 seeds that are each 0 5 millicuries you do not have to list each seed individually M 1 Records of Unit Dosage Use 30 51 35 21 35 53 You may use the following model procedure to keep a record of unit dosage use If you will follow the model procedure you may say on your application We will establish and implement the model procedure for a unit dosage record system that was published in Appendix M 1 to Regulatory Guide 10 8 Revision 2 If you prefer you may develop your own unit dosage record system for review If you do so you should consider for inclusion all the http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 45 of 83 features in the model procedure and carefully review the requirements of 30 51 35 21 and 35 53 Say on your application We have developed a procedure for a unit dosage record system for your review that is appended as ATT 10 8 and append your unit dosage record procedure MODEL PROCEDURE For each unit dosage received from a supplier make a record of the Radionuclide Generic name or its abbreviation or trade name Date of receipt Supplier Lot number or control number if assigned Activity in millicuries or microc
97. nal sources and to 100 mrem 1 mSv in a year total effective dose equivalent for individual members of the public Depending on how the licensee s hospital areas are controlled and monitored hallway areas outside patient therapy rooms and diagnostic areas will usually need to be limited to the radiation levels for unrestricted areas 5 NVLAP PROCESSORS See 10 CFR 20 1501 Personnel dosimeters that require processing to determine the dose to compare to the 10 CFR Part 20 dose limits must be processed and evaluated by a dosimetry processor that is accredited under the National Voluntary Laboratory Accreditation Program NVLAP 6 CONTROL OF LABORATORIES See 10 CFR 20 1101 20 1702 20 1801 20 1802 and 20 1902 Access to laboratories using radionuclides as well as the work practices in these laboratories need to be controlled Controlling access to radionuclide laboratories is accomplished by posting the entrance door and locking all accessible entrances to the laboratory when an authorized user or an individual under the supervision of an authorized user is not present An acceptable alternative is to provide lockable storage facilities within the laboratory In 10 CFR 20 1902 e posting is required for each area or room in which there is used or stored a quantity of licensed material exceeding 10 times the quantity in Appendix C to ww 20 1001 20 2401 Some of the Appendix C quantities are changed Appendix I to Revision 2 of Regulatory Guide
98. nd Table 2 1964 Page 40 of 83 4 Upgraded Emergency Preparedness for Certain Fuel Cycle and Materials Licensees Advance Notice of Proposed Rulemaking on Parts 30 40 and 70 46 FR 29712 Table 1 June 3 1981 Table J 1 may need to be modified before being used for guidance in a specific area of use TABLE J 1 Relative Hazards of Common Radionuclides Estimate the amount of radioactivity spilled Initiate a major or minor spill procedure based on the following dividing line Spills above these millicurie amounts are considered major below are considered minor Radionuclide Millicuries Radionuclide Millicuries P 32 10 Tc 99m 100 Cr 51 100 In 111 10 Co 57 100 1 123 10 Co 58 10 1 125 1 Fe 59 10 1 131 1 Co 60 1 Yb 169 10 Ga 67 100 Hg 197 100 Se 75 10 Au 198 10 Sr 85 10 TI 201 100 Spill Kit You may also want to consider assembling a spill kit that contains 6 pairs disposable gloves 1 pair housekeeping gloves 2 disposable lab coats 2 paper hats 2 pairs shoe covers 1 roll absorbent paper with plastic backing 6 plastic trash bags with twist ties Radioactive Material labeling tape 1 china pencil or marking pen 3 prestrung Radioactive Material labeling tags http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 41 of 83 Supplies for 10 contamination wipe samples Instructions for Emergency Procedures Clipboard with one copy of Radioactive Spill
99. nd for the exposure to the skin and to the lens of the eye see 10 CFR 20 1201 2 1 Units and Terms for Internal Exposure The revised 10 CFR Part 20 uses the special units of dose and activity and presents the corresponding values for the international system SD Records and reports required under the revised Part 20 are to be maintained using the special units The following table provides the conversions between the two systems of measurement Special Units Activity curie Ci 3 7 x 10 disintegrations per second 3 7 x 10 Bq Absorbed dose rad 100 ergs gram 0 01 Gy Dose equivalent rem Quality factor x rad 0 01 Sv SI Units Activity becquerel Bq 1 disintegration per second 2 7 x 10 Ci Absorbed dose gray Gy 1 joule kg 100 rads http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 76 of 83 Dose equivalent sievert Sv Quality factor x grays 100 rems In addition the revised Part 20 introduces new terms for radionuclide intakes by means of inhalation and ingestion e g derived air concentration DAC For a few radionuclides e g noble gases such as xenon the terms apply to exposures from submersion The new term DAC is used in broad terms similar to the way in which the maximum permissible concentration MPC is used in Appendix B Table I Column 1 to 10 CFR 20 1 20 601 and 20 103 Exposure to airborne radioactivity at a level
100. nd the model number and serial number of the dose calibrator Plot the data using the equivalent decay time associated with each sleeve Draw a best fit straight line through the data points For the point farthest from the line calculate its deviation from the value on the line A observed A line A line deviation If the worst deviation is more than 0 05 the dose calibrator should be repaired or adjusted If this cannot be done it will be necessary to make a correction table or graph that will allow you to convert from activity indicated by the dose calibrator to true activity Put a sticker on the dose calibrator that says when the next linearity test is due 6 Geometry independence means that the indicated activity does not change with volume or configuration This test should be done using a syringe that is normally used for injections Licensees who use generators and radiopharmaceutical kits should also do the test using a vial similar in size shape and construction to the radiopharmaceutical kit vials normally used The following test assumes injections are done with 3 cc plastic syringes and that radiopharmaceutical kits are made in 30 cc glass vials If you do not use these change the procedure so that your syringes and vials are tested throughout the range of volumes commonly used a b In a small beaker or vial mix 2 cc of a solution of Tc 99m with an activity concentration between 1 and 10 mCi ml Set out a sec
101. ng one patient study in a plastic bag and then monitor the activity in the bag by holding the bag against a camera with the camera adjusted to detect the noble gas and compare its counts per minute cpm to background cpm with no other radioactivity in the area Keep a record of the date background cpm and bag cpm 3 The RSO will establish an action level based on cpm or a multiple of background cpm If you measure a significant increase in the bag cpm the trap is breaking down and must be replaced 4 Follow the trap manufacturer s instructions for replacing the trap PUBLIC DOSE FROM AIRBORNE EFFLUENT ITEM 10 13 3 Effluent release presents a potential source of dose to the public Usually a calculation of concentration at the release point is done and compared to the appropriate value of Table II of Appendix B to 10 CFR Part 20 If you are not directly venting aerosols and gases to the atmosphere you may respond to Item 10 13 3 by saying We will not directly vent spent aerosols and gases to the atmosphere and therefore no effluent estimation is necessary If you are going to vent aerosols or gases to the atmosphere you must estimate effluent concentrations by calculation You do not have to submit the calculations with your application but you should keep them for NRC review during inspections If you will follow the model procedure below for calculating release concentrations you may respond to Item 10 13 3 by saying We will follow
102. nsas Louisiana Montana Nebraska New Mexico North Dakota Oklahoma South Dakota Texas Utah or Wyoming send your applications to the U S Nuclear Regulatory Commission Region IV Material Radiation Protection Section 611 Ryan Plaza Drive Suite 1000 Arlington TX 76011 If you are located in Alaska Arizona California Hawaii Nevada Oregon Washington or U S territories and possession in the Pacific send your applications to the U S Nuclear Regulatory Commission Region V Material Radiation Protection Section 1450 Maria Lane Suite 210 Walnut Creek CA 94596 3 CONTENTS OF APPLICATION This portion of the guide explains item by item the information requested on NRC Form 313 Exhibit 1 The appendices to this guide serve several different purposes i e to provide additional information on certain subject areas to provide a model procedure the licensee may adopt in response to an item on the application form or to provide an outline the applicant may use to develop a procedure for review by the NRC staff The exhibits following the appendices include copies of the application form NRC Form 313 Exhibit 1 Supplements A and B Exhibits 2 and 3 that may be used to document training and experience and two logs to document training the Resident s Support http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 9 of 83 Technology Training Task Log Exhibit 4 and Resident s
103. nt A see Exhibit 2 with Items 1 2 and 3 completed A physician certified as a British Fellow of the Faculty of Radiology FFR or Fellow of the Royal College of Radiology FRCR should submit a copy of the certificate and evidence of specialization in radiation therapy 4 Physicians not previously authorized by AEC or NRC or an Agreement State and not certified by an appropriate organization must submit a complete description of their training and experience using Supplements A and B see Exhibits 2 and 3 This documentation will be reviewed on a case by case basis If the training and experience does not appear to meet the Subpart J standards the NRC will request the assistance of its Advisory Committee on the Medical Uses of Isotopes 5 Broad scope medical use applicants should submit the criteria they will use to evaluate the training and experience of authorized users Subpart J may be used as a guide The criteria may include a provision that allows the applicant s Radiation Safety Committee to grant case by case exceptions 7 2 Authorized Users for Nonmedical Use http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 12 of 83 List the full name of each individual proposed as an authorized user for nonmedical use Submit a complete description of the person 5 training and experience using Supplement A Exhibit 2 If the individual was already identified in Item 7 1 no additional
104. o determine those items to which you must respond highlight the columns under the categories of material you requested in Item 5 If any 4 beside an item is highlighted you must provide information in response to the item If only the letters NA not applicable are highlighted you may respond NA in your application Material in 10 CFR Sections Item Topic 35 100 35 200 35 300 35 400 35 500 Other App 8 1 Training program vf vf vf Y Y NA A 8 2 Other training program NA NA NA NA NA we 9 1 Annotated drawing ri ff if ri ri Pi Exh 1 9 2 Survey instrument calibration g Fi Pi wt Pi ft B 9 3 Dose calibrater calibration i Y of NA NA NA C 9 4 Personnel monitor program Fi we Y Pi NA we D http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 13 of 83 9 5 Imaging equipment QA See special instruction 9 5 in the text E 9 6 Other equipment facilities NA NA NA NA NA Pi 10 1 Radiation Safety Committee Radiation Safety Officer See special instruction 10 1 in the text F 10 2 ALARA program See special instruction 10 2 in the text G 10 3 Leak test Y Y S Y Y NA H 10 4 Safe use of radiopharmaceuticals VY VY VY NA NA NA I 10 5 Spill procedures F Wa Y NA NA NA J 10 6 Ordering and receiving i vw 7 Fa Fa Fa K 10 7 Opening packages Y Fd Pd Fd Fd Fa L 10 8 Unit dose records Y Pa Pi NA NA NA M 10 9 Multidose vial records Y Pa Y NA NA NA M 10 10 Mo 99 concentration records NA S NA NA NA NA
105. of Documents U S Government Printing Office Washington DC 20402 7 NRC documents may be purchased from the U S Government Printing Office Post Office Box 37082 Washington DC 20013 7082 or the National Technical Information Service Springfield VA 22161 Regulatory Guide 8 20 Applications of Bioassay for I 125 and 1 131 8 Draft regulatory guides may be obtained at no charge by writing to the U S Nuclear Regulatory Commission Washington DC 20555 Attention Director Division of Information Support Services 9 IAEA reports may be obtained from UNIPUB Inc 345 Park Avenue South New York NY 10010 10ICRP reports may be obtained from Pergamon Press Maxwell House Fairview Park Elmsford NY 10523 11JCRU reports may be obtained from ICRU Publications 7910 Woodmont Avenue Suite 1016 Bethesda MD 20814 12NCRP reports may be obtained from NCRP Publications 7910 Woodmont Avenue Suite 1016 Bethesda MD 20814 13 ANSI standards may be obtained from the American National Standards Institute Inc 1430 Broadway New York NY 10018 14NCRP reports can be purchased by writing to NCRP Publications 7910 Woodmont Avenue Suite 800 Bethesda MD 20814 http www nrc gov NRC RG 10 10 008r2 html 11 24 99
106. on Survey Example Package Receipt and Monitor Log Package Receipt and Monitor Log Example Unit Dosage Receipt and Use Log Unit Dosage Receipt and Use Log Example Multidose Vial Preparation and Use Log Multidose Vial Preparation and Use Log Example Short Lived Implant Source Log Short Lived Implant Source Log Example Radiation Survey Radiation Survey Example Nursing Instructions for Patients Treated with Iodine 131 Phosphorus 32 or Gold 198 Nursing Instructions for Patients Treated with Iodine 131 Phosphorus 32 or Gold 198 Example Radiation Safety Checklist for Iodine Therapy Over 30 Millicuries Radiation Safety Checklist for Temporary Implant Therapy Nursing Instructions for Patients Treated with Temporary Implant Sources Nursing Instructions for Patients Treated with Temporary Implant Sources Example Sample Cesium Implant Source Log Sample Cesium Implant Source Log Example Page 82 of 83 EXH 18 EXH 19 EXH 20 EXH 21 EXH 22 EXH 23 EXH 24 EXH 25 EXH 26 EXH 27 EXH 28 EXH 29 EXH 30 EXH 31 EXH 32 EXH 33 EXH 34 EXH 35 EXH 36 EXH 37 EXH 38 EXH 39 VALUEAMPACT STATEMENT A draft value impact statement was published with the proposed Revision 2 to Regulatory Guide 10 8 Task FC 415 4 when the draft guide was published for public comment in August 1985 No changes were necessary so a separate value impact statement for the final guide has
107. ond small beaker or vial with nonradioactive saline You may also use tap water Draw 0 5 cc of the Tc 99m solution into the syringe and assay it Record the volume and millicuries indicated on the Dose Calibrator Geometry and Accuracy Form see Exhibit 9 Remove the syringe from the calibrator draw an additional 0 5 cc of nonradioactive saline or tap water and assay again Record the volume and millicuries indicated Repeat the process until you have assayed a 2 0 cc volume Select as a standard the volume closest to that normally used for injections For all the other volumes divide the standard millicuries by the millicuries indicated for each volume The quotient is a volume correction factor Alternatively you may graph the data and draw horizontal 5 percent error lines above and below the chosen standard volume If any correction factors are greater than 1 05 or less than 0 95 or if any data points lie outside the 5 percent error lines it http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 26 of 83 will be necessary to make a correction table or graph that will allow you to convert from indicated activity to true activity If this is necessary be sure to label the table or graph syringe geometry dependence and note the date of the test and the model number and serial number of the calibrator To test the geometry dependence for a 30 cc glass vial draw 1 0 cc of the Tc 99m
108. or measuring and recording molybdenum concentration MODEL PROCEDURE Each time a generator is eluted make a record of the 1 Date the generator was received 2 Date and time of elution 3 Measured Mo 99 activity in microcuries 4 Product of the measured Mo 99 activity and the correction factor noted by the molybdenum breakthrough pig manufacturer 5 Measured Tc 99m activity in millicuries 6 Ratio of the total Mo 99 microcuries per millicurie of Tc 99m and checkmark that the ratio is less than 0 07 microcurie of Mo 99 per millicurie of Tc 99m If it isn t stop and notify the RSO In conformance with paragraph 21 21 b of 10 CFR Part 21 the licensee must notify the NRC if a leaking generator is detected The 0 07 action level allows for the quicker decay of the Tc through the day of use It is assumed that the material will be used within 6 hours at which time the concentration of Mo 99 to Tc 99m would have doubled 7 Initials of the person who made the record M 4 Keeping an Inventory of Implant Sources 30 51 35 21 35 406 You may use the following model procedure to keep an inventory and use record for implant sources If you will follow the model procedure you may say on your application We will establish and implement the model procedure for keeping an inventory of implant sources that was published in Appendix M 4 to Regulatory Guide 10 8 Revision 2 If you prefer you may develop your own procedure for keeping an inv
109. orts to Workers Inspections Part 20 Standards for Protection Against Radiation Part 21 Reporting of Defects and Noncompliance Part 30 Rules of General Applicability to Domestic Licensing of Byproduct Material Part 31 General Domestic Licenses for Byproduct Material Part 32 Specific Domestic Licenses To Manufacture or Transfer Certain Items Containing Byproduct Material Part 33 Specific Domestic Licenses of Broad Scope for Byproduct Material Part 35 Medical Use of Byproduct Material Part 40 Domestic Licensing of Source Material Part 70 Domestic Licensing of Special Nuclear Material Part 71 Packaging and Transportation of Radioactive Material Part 170 Fees for Facilities and Materials Licenses and Other Regulatory Services Under the Atomic Energy Act of 1954 As Amended USNRC Regulatory Guides Regulatory Guide 8 4 Direct Reading and Indirect Reading Pocket Dosimeters Regulatory Guide 8 10 Operating Philosophy for Maintaining Occupational Radiation Exposures As Low As Is Reasonably Achievable Regulatory Guide 8 13 Instruction Concerning Prenatal Radiation Exposure Regulatory Guide 8 18 Information Relevant to Ensuring That Occupational Radiation Exposures at Medical Institutions Will Be As Low http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 71 of 83 As Reasonably Achievable Regulatory Guide 8 23 Radiation Safety Surveys at Medical Institutions
110. ory Guide 10 8 Revision 2 If you are not monitoring trap effluent or if you exhaust spent gas to the atmosphere you must estimate worker dose by calculation You do not have to submit the calculations but you should keep them for NRC review during inspections If you will follow the model procedure below for calculating worker dose from noble gases you may respond to Item 10 13 1 by saying We will follow the model procedure for calculating worker dose from noble gases that was published in Appendix 0 1 to Regulatory Guide 10 8 Revision 2 If none of the above apply you may develop your own procedure for review If you do so you should consider all the above information and carefully review the requirements of 20 103 20 201 35 90 and 35 205 Say on your application We have developed a procedure for monitoring worker dose due to submersion in noble gases that is appended as ATT 10 13 1 and append your procedure for monitoring worker dose from noble gases WORKER DOSE FROM AEROSOLS Item 10 13 2 If you will collect spent aerosol in a shielded trap will use an air contamination monitor for reusable traps and will follow the monitor manufacturer s instructions for checking for accuracy and constancy you may respond to Item 10 13 2 by saying We will collect spent aerosol in a shielded trap and for reusable traps monitor the trap effluent with an air contamination monitor that we will check regularly according to the manufacturer
111. p www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 23 of 83 APPENDIX C Model Procedure for Calibrating Dose Calibrator See 35 50 You or your contractor may use the following model procedure for checking and testing the dose calibrator If you or the contractor follow the model procedure you may say on your application We will establish and implement the model procedure for calibrating our dose calibrator that was published in Appendix C to Regulatory Guide 10 8 Revision 2 If you develop your own dose calibrator calibration procedure for review you should carefully review 35 50 and all the features in the model procedure Say on your application We have developed a dose calibrator calibration procedure for your review that is appended as ATT 9 3 and append your dose calibrator calibration procedure MODEL PROCEDURE Test for the following at the indicated frequency Consider repair replacement or arithmetic correction if the dose calibrator falls outside the suggested tolerances These recommended tolerances are more restrictive than those in the regulations to ensure that corrective action will be taken before the dose calibrator is outside permissible tolerances a Constancy at least once each day prior to assay of patient dosages 5 percent b Linearity at installation and at least quarterly thereafter 5 percent re Geometry dependence at installat
112. pment of ALARA Procedures Radiation workers will be given opportunities to participate in formulating the procedures that they will be required to follow 1 The RSO will be in close contact with all users and workers in order to develop ALARA procedures for working with radioactive materials 2 The RSO will establish procedures for receiving and evaluating the suggestions of individual workers for improving health physics practices and will encourage the use of those procedures d Reviewing Instances of Deviation from Good ALARA Practices The RSO will investigate all known instances of deviation from good ALARA practices and if possible will determine the causes When the cause is known the RSO will implement changes in the program to maintain doses ALARA 4 Authorized http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 34 of 83 Users a New Methods of Use Involving Potential Radiation Doses 1 The authorized user will consult with the RSO and or RSC during the planning stage before using radioactive materials for new uses 2 The authorized user will review each planned use of radioactive materials to ensure that doses will be kept ALARA Trial runs may be helpful Authorized User s Responsibility to Supervised Individuals 1 The authorized user will explain the ALARA concept and the need to maintain exposures ALARA to all supervised individuals 2 The authori
113. posal e g toxicity carcinogenicity pathogenicity flammability and expense MODEL PROCEDURE FOR DISPOSAL OF LIQUIDS AND GASES Liquids may be disposed of by release to the sanitary sewer or evaporative release to the atmosphere This does not relieve licensees from complying with other regulations regarding toxic or hazardous properties of these materials 1 Regulations for disposal in the sanitary sewer appear in 20 303 Material must be readily soluble or dispersible in the water There are daily and monthly limits based on the total sanitary sewerage release of your facility Excreta from patients undergoing medical diagnosis or therapy is exempt from all the above limitations see paragraph 20 303 d Make a record of the date radionuclide http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 58 of 83 estimated activity that was released in millicuries or microcuries and of the sink or toilet at which the material was released 2 Limits on permissible concentrations in effluents to unrestricted areas are enumerated in Table II of Appendix B to 10 CFR Part 20 These limits apply at the boundary of the restricted area Make a record of the date radionuclide estimated activity that was released in millicuries or microcuries and estimated concentration and of the vent site at which the material was released 3 Liquid scintillation counting media containing 0 05 millicurie per gr
114. ps b through g above From the graph made in step d of the decay method find the decay time associated with the activity indicated with sleeve 1 in place This is the equivalent decay time for sleeve 1 Record that time with the data recorded in step b g Find the decay time associated with the activity indicated with sleeve 2 in place This is the equivalent decay time for sleeve 2 Record that time with the data recorded in step c mo BOS http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 25 of 83 h i Continue for all sleeves The table of sleeve numbers and equivalent decay times constitutes the calibration of the sleeve set The sleeve set may now be used to test dose calibrators for linearity a moO BROS j Assay the Tc 99m syringe or vial in the dose calibrator and subtract background to obtain the net activity in millicuries Record the net activity Steps c through e below must be completed within 6 minutes Put the base and sleeve 1 in the dose calibrator with the vial Record the sleeve number and indicated activity Remove sleeve 1 and put in sleeve 2 Record the sleeve number and indicated activity Continue for all sleeves On a sheet of semilog graph paper or on a copy of the sample form in Exhibit 8 label the logarithmic vertical axis in millicuries and label the linear horizontal axis in hours elapsed At the top of the graph note the date a
115. quired by 10 CFR Part 19 10Question and answer period OANNDMNFP WN Re http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 21 of 83 APPENDIX B Model Procedure for Calibrating Survey Instruments See 35 51 You or your contractor may use the following guidance to calibrate survey instruments If you or the contractor follow all the guidance you may say on your application We will establish and implement the model procedure for calibrating survey instruments that was published in Appendix B to Regulatory Guide 10 8 Revision 2 If your procedure does not follow the guidance in the model you may develop your own procedure for review If you do so you should consider for inclusion all the features in the model and carefully review the requirements of 35 51 Say on your application We have developed a survey instrument calibration procedure for your review that is appended as ATT 9 2 and append your survey instrument calibration procedure Radiation survey meters should be calibrated with a radioactive source Electronic calibrations alone are not acceptable Survey meters must be calibrated at least annually and after servicing Battery changes are not considered servicing MODEL PROCEDURE 1 The source must be approximately a point source Either the apparent source activity or the exposure rate at a given distance must be traceable by documented measurements to
116. r on a copy of the sample form in Exhibit 8 label the logarithmic vertical axis in millicuries and label the linear horizontal axis in hours elapsed At the top of the graph note the date and the manufacturer model number and serial number of the dose calibrator Then plot the data e Draw a best fit straight line through the data points For the point farthest from the line calculate its deviation from the value on the line A observed A line A line deviation f If the worst deviation is more than 0 05 the dose calibrator should be repaired or adjusted If this cannot be done it will be necessary to make a correction table or graph that will allow you to convert from activity indicated by the dose calibrator to true activity g Put a sticker on the dose calibrator that says when the next linearity test is due Shield Method If you decide to use a set of sleeves of various thicknesses to test for linearity it will first be necessary to calibrate them a Begin the linearity test as described in the decay method described above After making the first assay the sleeves can be calibrated as follows Steps b through d below must be completed within 6 minutes Put the base and sleeve 1 in the dose calibrator with the vial Record the sleeve number and indicated activity Remove sleeve 1 and put in sleeve 2 Record the sleeve number and indicated activity Continue for all sleeves Complete the decay method linearity test ste
117. rations This will include reviews of operating procedures and past dose records inspections etc and consultations with the radiation safety staff or outside consultants Modifications to operating and maintenance procedures and to equipment and facilities will be made if they will reduce exposures unless the cost in our judgment is considered to be unjustified We will be able to demonstrate if necessary that improvements have been sought that modifications have been considered and that they have been implemented when reasonable If modifications have been recommended but not implemented we will be prepared to describe the reasons for not implementing them In addition to maintaining doses to individuals as far below the limits as is reasonably achievable the sum of the doses received by all exposed individuals will also be maintained at the lowest practicable level It would not be desirable for example to hold the highest doses to individuals to some fraction of the applicable limit if this involved exposing additional people and significantly increasing the sum of radiation doses received by all involved individuals 2 Radiation Safety Committee a Review of Proposed Users and Uses 1 The RSC will thoroughly review the qualifications of each applicant with respect to the types and quantities of materials and methods of use for which application has been made to ensure that the applicant will be able to take appropriate measures to
118. rized user Technologists or other personnel may use byproduct material under an authorized user s supervision when permitted under applicable Federal State or local laws Supervision is defined in 35 25 For in vitro and animal research or other uses that do not involve the intentional exposure of humans the list of proposed authorized users should include those individuals who will actually be responsible for the safe use of the byproduct material for the requested use Note which user will be involved with which use by reference to Items 5 and 6 of the application Those authorized users may direct the use of the byproduct material by technologists or other individuals for the requested use 7 1 Authorized Users for Medical Use 1 Make a separate attachment for the RSO and each authorized user Number the attachments ATT 7 1 1 ATT 7 1 2 etc Type the full name of the individual and note by reference to Items 5 a 5 b etc which proposed uses are requested for the individual 2 If a physician has been previously authorized for medical use and only wants to use material permitted by the previous license you only need to submit the previous license number if issued by AEC or NRC or a copy of the license if issued by an Agreement State on which the physician was specifically named as an authorized user 3 If a physician is certified by an organization listed in the appropriate section of Subpart 3 of 10 CFR Part 35 submit Suppleme
119. rom security physical plant housekeeping and other departments Adjunct members should abstain from balloting on radiation safety technical questions such as Items 2 through 5 in the Responsibilities section above To establish a quorum one half of the Committee s membership including the RSO and the management representative must be http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 31 of 83 present 4 To the extent that they do not interfere with the mission of the Committee management may assign other responsibilities such as x ray radiation safety quality assurance oversight and research project review and approval MODEL DELEGATION OF AUTHORITY Memo To All Employees From Chief Executive Officer Subject Delegation of Authority has been appointed Radiation Safety Officer and is responsible for ensuring the safe use of radiation The Radiation Safety Officer is responsible for managing the radiation safety program identifying radiation safety problems initiating recommending or providing corrective actions verifying implementation of corrective actions and ensuring compliance with regulations The Radiation Safety Officer is hereby delegated the authority necessary to meet those responsibilities The Radiation Safety Officer is also responsible for assisting the Radiation Safety Committee in the performance of its duties and serving as its secretary APPEND
120. rpendicular indicating photons traveling either parallel with or perpendicular to the central axis of the detector for instruments with internal detectors this should be the angle between the flux field and a specified surface of the instrument For detectors with removable shielding an indication of whether the shielding was in place or removed during the calibration procedure The apparent exposure rate from the check source and The name of the person who performed the calibration and the date on which the calibration was performed 12 The following information will be attached to the instrument as a calibration sticker or tag a b For each scale or decade one of the following as appropriate c d e The source that was used to calibrate the instrument The proper deflection in the battery check mode unless this is clearly indicated on the instrument 1 The average correction factor 2 A graph or graphs from which the correction factor for each scale or decade may be deduced or 3 An indication that the scale was checked for function but not calibrated or an indication that the scale was inoperative The angle between the radiation flux and the detector during the calibration and The apparent exposure rate from the check source Note One word reminders or symbols that are explained on the Survey Meter Calibration Report may be used on the calibration sticker See Exhibit 7 for a form you may want to use htt
121. rs doses need to exceed an investigational level a new higher investigational level may be established for that individual or group on the basis that it is consistent with good ALARA practices Justification for new investigational levels will be documented The RSC will review the justification for and must approve or disapprove all revisions of investigational levels 7 Signature of Certifying Official I hereby certify that this institution has implemented the ALARA Program set forth above Signature Name print or type Title Table 1 Investigational Levels mrems per calendar quarter Level I Level II 1 Whole body head and trunk active blood forming organs lens of eyes or gonads 125 375 2 Hands and forearms feet and ankles 1875 5625 3 Skin of whole body 750 2250 APPENDIX H Model Procedure for Leak Testing Sealed Sources See 35 59 You or your contractor may use the following model procedure to leak test sealed sources If you or the contractor follow the model procedure you may say on your application We will establish and implement the model procedure for leak testing sealed sources that was http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 36 of 83 published in Appendix H to Regulatory Guide 10 8 Revision 2 You may develop your own procedure for review If you do so you should consider for inclusion all the features in the model
122. rts for maintaining doses ALARA on an annual basis This review will include the efforts of the RSO authorized users and workers as well as those of management 3 Radiation Safety Officer a Annual and Quarterly Review 1 Annual review of the radiation safety program The RSO will perform an annual review of the radiation safety program for adherence to ALARA concepts Reviews of specific methods of use may be conducted on a more frequent basis 2 Quarterly review of occupational exposures The RSO will review at least quarterly the external radiation doses of authorized users and workers to determine that their doses are ALARA in accordance with the provisions of Section 6 of this program and will prepare a summary report for the RSC 3 Quarterly review of records of radiation surveys The RSO will review radiation surveys in unrestricted and restricted areas to determine that dose rates and amounts of contamination were at ALARA levels during the previous quarter and will prepare a summary report for the RSC b Education Responsibilities for ALARA Program 1 The RSO will schedule briefings and educational sessions to inform workers of ALARA program efforts 2 The RSO will ensure that authorized users workers and ancillary personnel who may be exposed to radiation will be instructed in the ALARA philosophy and informed that management the RSC and the RSO are committed to implementing the ALARA concept c Cooperative Efforts for Develo
123. ructions you received from the transfer agent and the burial site operator For your record of disposal keep the consignment sheet that the transfer agent gave you MODEL PROCEDURE FOR RELEASE TO IN HOUSE WASTE Waste from in vitro kits that are generally licensed pursuant to 31 11 is exempt from waste disposal regulations Radioactive labels should be defaced or removed There is no need to keep any record of release or make any measurement MODEL PROCEDURE FOR RETURNING GENERATORS TO THE MANUFACTURER Used Mo 99 Tc 99m generators may be returned to the manufacturer This permission does not relieve licensees from the requirement to comply with 10 CFR Part 71 and Department of Transportation DOT regulations 1 Retain the records needed to demonstrate that the package qualifies as a DOT Specification 7A container see DOT regulations paragraph 173 415 a of 49 CFR Part 173 2 Assemble the package in accordance with the manufacturer s instructions 3 Perform the dose rate and removable contamination measurements required by paragraph 173 475 i of 49 CFR Part 173 4 Label the package and complete the shipping papers in accordance with the manufacturer s instructions Part 2 ADDITIONAL INFORMATION FOR MANAGING RADIATION SAFETY PROGRAMS FOR MEDICAL USE LICENSEES APPENDIX S Regulatory Requirements The following documents provide licensees with a summary of the information considered by the Commission when preparing the revision of
124. rvey meter calibration service 10 Vial shields 11 Personnel shields Subpart E http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 63 of 83 en 9 10 11 12 13 14 15 16 17 Subpart F S RN A EO DO Dora Subpart G 1 Radiation detection survey meter Radiation measurement survey meter Dose calibrator Constancy check source Sealed sources for dose calibrator accuracy test Leak test service for sealed sources Syringe shield Hot lab area monitor Flood source for gamma cameras PLES bar orthogonal hole or quadrant phantom for gamma cameras Lead L block Fume hood Radioactive aerosol and gas administration system and trap Personnel monitoring service Survey meter calibration service Vial shields Personnel shields Radiation detection survey meter Radiation measurement survey meter Dose calibrator Constancy check source Sealed sources for dose calibrator accuracy test Leak test service for sealed sources Syringe shield Fume hood Personnel monitoring service Survey meter calibration service Vial shields Personnel shields Radiation detection survey meter http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 64 of 83 Radiation measurement survey meter Lead L block Remote handling tools Shielded transport cart Shielded storage safe Leak test service for seale
125. s New York NY 1983 Sanborn Jeffrey Radiation Safety During Nursing Care of Patients Receiving Internal Radiotherapy Maine Medical Center 22 Bramhall Street Portland ME 04102 undated Shapiro Jacob Radiation Protection A Guide for Scientists and Physicians Second Edition Harvard University Press Cambridge MA 1981 Steere Norman V Editor Handbook of Laboratory Safety chapter on Determining Industrial Hygiene Requirements in Installations Using Radioactive Materials pp 482 502 also Basic Units of Radiation Measurement pp 391 426 CRC Press Inc 2000 N W 24th Street Boca Raton FL 33431 1970 Wang Yen Editor Handbook of Radioactive Nuclides Part VIII Radiation Protection and Regulation CRC Press Inc 2000 N W 24th Street Boca Raton FL 33431 pp 573 831 1969 APPENDIX X Guidance on Complying With New Part 20 Requirements to Regulatory Guide 10 8 Revision 2 Draft was issued as DG 0002 The revision of 10 CFR Part 20 Standards for Protection Against Radiation ww 20 1001 20 2401 changes a number of the requirements for medical use programs The major change in the revised Part 20 is to incorporate newer national and international concepts on radiation protection including the application of a risk based approach to the establishment of radiation protection limits Included are the adoption of the effective dose concept specification of occupational dose limits as the sum of int
126. side the site boundary access to which can be limited by the licensee for any reason Entrance or access point means any location through which an individual could gain access to radiation areas or to radioactive materials This includes entry or exit portals of sufficient size to permit human entry irrespective of their intended use Radiation area means an area accessible to individuals in which radiation levels could result in an individual receiving a dose equivalent in excess of 5 mrem 0 05 mSv in 1 hour at 30 centimeters from the radiation source or from any surface that the radiation penetrates Restricted area means an area access to which is limited by the licensee for the purpose of protecting individuals against undue risks from exposure to radiation and radioactive materials Restricted area does not include areas used as residential quarters but separate rooms in a residential building may be set apart as a restricted area Site boundary means that line beyond which the land or property is not owned leased or otherwise controlled by the licensee Unrestricted area means an area access to which is neither limited nor controlled by the licensee http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 79 of 83 The radiation levels in unrestricted areas from operations or releases of radionuclides in effluents are restricted to 2 mrem 20 uSv in any 1 hour from exter
127. solution into a syringe and then inject it into the vial Assay the vial Record the volume and millicuries indicated Remove the vial from the calibrator and using a clean syringe inject 2 0 cc of nonradioactive saline or tap water and assay again Record the volume and millicuries indicated Repeat the process until you have assayed a 19 0 cc volume The entire process must be completed within 10 minutes Select as a standard the volume closest to that normally used for mixing radiopharmaceutical kits For all the other volumes divide the standard millicuries by the millicuries indicated for each volume The quotient is a volume correction factor Alternatively you may graph the data and draw horizontal 5 percent error lines above and below the chosen standard volume If any correction factors are greater than 1 05 or less than 0 95 or if any data points lie outside the 5 percent error lines it will be necessary to make a correction table or graph that will allow you to convert from indicated activity to true activity If this is necessary be sure to label the table or graph vial geometry dependence and note the date of the test and the model number and serial number of the calibrator 7 Accuracy means that for a given calibrated reference source the indicated millicurie value is equal to the millicurie value determined by the National Bureau of Standards NBS or by the supplier who has compared that source to a source that was calibrat
128. ssociated with design engineering controls and operating procedures have been optimized in accordance with the ALARA principle If a quantitative analysis cannot be readily performed licensees should thoroughly evaluate any design or engineering controls that may need to be changed to keep operating procedures ALARA Examples of the type of ALARA optimization considerations appropriate to the conduct of medical use programs are presented in the National Council on Radiation Protection and Measurement NCRP Report No 107 Implementation of the Principle of As Low As Is Reasonably Achievable ALARA for Medical and Dental Personnel 4 December 31 1990 This NCRP report provides specific hypothetical examples of optimization decisions in implementing ALARA in nuclear medicine and radiation oncology 2 INTERNAL DOSE METHODOLOGY The revised 10 CFR Part 20 incorporates the new dose methodology system developed by the International Commission on Radiological Protection ICRP which specifies radiation dose limits in terms of an equivalent whole body dose taken to be the sum of individual organ committed doses weighted by the risk of biological effect for each of the organs irradiated This effective dose equivalent concept is used to control the stochastic biological effects of exposure to ionizing radiation Nonstochastic or threshold biological effects are avoided by establishing dose limits for the committed dose received by an individual organ a
129. ssued for One Address If your organization named on the license or application holds multiple NRC licenses all of which are issued to the same address check the box that most closely approximates the annual receipts or annual operating budget for your entire organization regardless of the number of NRC licenses possessed at that single address 3 Holders bf Multiple NRC Licenses at Multiple Addresses If your organization named on the license or application holds multiple NRC licenses at multiple addresses check the box that most closely approximates the annual recejpts or annual operating budget for the operations conducted at the address on this license or application and not for the entire corporate entity 14 b Number of Employees The number of employees reported should reflect all employees for the organization at the address listed on the license or application excluding outside contractors The number of employees reported should not be that of a single department or division within the organization 14 c Number of Beds Hospitals Only Enter the total number of beds in the hospital excluding bassinets and nursing home type units 14 d Would You Be Willing To Furnish Cost Information on the Economic Impact of Current Regulations or any Future Proposed NRC Regulations That May Affect You Indicate if you would be willing to furnish additional economic data to the NRC that would help the NRC evaluate the economic impact of
130. st http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 78 of 83 dose as was done previously 3 DECLARED PREGNANT WOMEN Embryo Fetus Dose Limits See 10 CFR 20 1003 and 20 1208 The revised Part 20 uses the term declared pregnant woman to mean a woman who has voluntarily informed her employer in writing of her pregnancy and the estimated date of conception For declared pregnant women the NRC limits the dose to the embryo fetus to 0 5 rem 5 mSv over the entire pregnancy In addition the licensee is required to make an effort to avoid substantial variation above a uniform monthly exposure rate 0 05 rem month 0 5 mSv month Declared pregnant women are not allowed to receive planned special exposures that involve whole body doses or maternal intakes that could result in exceeding the embryo fetus dose limit The radiation protection program should make provisions for instructing women workers about the special need to protect the embryo fetus and to encourage them to promptly notify their employer if they become pregnant Regulatory Guide 8 36 Radiation Dose to the Embryo Fetus contains guidance on evaluating the dose to the embryo fetus 4 LEVELS IN UNRESTRICTED AREAS See 10 CFR 20 1301 and 20 1302 The revised Part 20 uses the following terms with regard to areas with or without radiological restrictions Controlled area means an area outside of a restricted area but in
131. staff position on this important subject Applicants should consider the ALARA philosophy as described in Regulatory Guides 8 10 and 8 18 in developing plans for work with licensed radioactive materials 1 3 1 General ALARA Considerations Each individual who is authorized to use byproduct material should provide appropriate instruction to all individuals who work with or in the vicinity of byproduct material and should ensure that the facility and equipment are adequate for safe use NUREG 1134 Radiation Protection Training for Personnel Employed in Medical Facilities provides information on training programs for use by medical use licensees Each worker should follow procedures developed to ensure safety and should promptly report incidents and potential problems to the authorized user or Radiation Safety Office RSO 1 3 2 ALARA in Medical Institutions Each medical licensee must have a formal ALARA program see 35 20 of 10 CFR Part 35 The success of an ALARA program depends on the cooperation of each person who works at the licensee s facility Management should make a formal policy commitment to the ALARA philosophy and implement that commitment with adequate resources A Radiation Safety Committee composed of individuals who have special expertise in the safe use of byproduct material is required by 35 22 to reyiew uses for safety and ALARA considerations See Section 1 4 2 of this guide The Committee the RSO and management shoul
132. stitution licensee see 35 22 unless the application is only for devices listed in 35 500 such institutions will be exempted by license condition If you are not an institution you only need to submit the Radiation Safety Officer delegation of authority See Appendix F 10 2 ALARA Program Submit your ALARA program Each medical licensee must have an ALARA program see 35 20 unless the application is only for devices listed in 35 500 such institutions will be exempt by license condition If you are only applying for devices in 35 500 say NA Otherwise see Appendix G 10 3 Leak Test Submit your procedure for leak testing sealed sources See Appendix H 10 4 Safe Use of Radiopharmaceuticals Submit a copy of your rules for the safe use of radiopharmaceuticals See Appendix I 10 5 Spill Procedures Submit a copy of your spill procedures See Appendix 3 10 6 Ordering and Receiving Submit a copy of your procedure for ordering and receiving radioactive material See Appendix K 10 7 Opening Packages Submit your procedure for opening packages that contain radioactive material See Appendix L 10 8 Unit Dosage Records Submit your procedure for keeping records of unit dosage use See Appendix M 1 http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 16 of 83 10 9 Multidose Vial Records Submit your procedure for keeping records of multidose vial use See Append
133. survey meter to be sure it will easily detect a seed that has not been removed or has been lost 9 Do not release any patient who has received a permanent implant from the hospital until the exposure rate from the patient is less than 5 mR hr at 1 meter Measure this exposure rate with a radiation measurement survey meter at a distance of 1 meter from the umbilicus with the patient standing You may want to use the sample forms in Exhibit 19 Radiation Safety Checklist for Temporary Implant Therapy Exhibit 20 Nursing Instructions for Patients Treated with Temporary Implant Sources and Exhibit 21 Sample Cesium Implant Source Log APPENDIX R Model Procedure for Waste Disposal http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 57 of 83 See 20 301 20 303 20 306 and 35 92 The following general guidance and procedure may be used for disposal of radioactive waste If you follow all the general guidance and procedures you may say on your application We will establish and implement the general guidance and model procedures for waste disposal that were published in Appendix R to Regulatory Guide 10 8 Revision 2 If you prefer you may develop your own procedure for review If you do so you should consider for inclusion all the features in the general guidance and models and carefully review the requirements of 20 301 20 303 20 306 and 35 92 Say on your applicat
134. the model procedure for calculating airborne effluent concentration that was published in Appendix 0 2 to Regulatory Guide 10 8 Revision 2 If neither of the above apply you may develop your own procedure for review If you do so you should consider all the above information http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 53 of 83 and carefully review the requirements of 20 106 20 201 35 90 and 35 205 Say on your application We have developed a procedure for monitoring airborne effluent concentration that is appended as ATT 10 13 3 and append your procedure for monitoring airborne effluent concentration SPILLED GAS CLEARANCE TIME Item 10 13 4 Because normal room ventilation is usually not sufficient to ensure timely clearance of spilled gas the calculations described in Appendix O 4 should be done to determine for how long a room should be cleared in case of a gas spill This clearance time should be posted in the room If you will calculate spilled gas clearance times according to the following procedure you may respond to Item 10 13 4 by saying We will calculate spilled gas clearance times according to the procedure that was published in Appendix O 4 to Regulatory Guide 10 8 Revision 2 You may develop your own procedure for review If you do so you should consider all the above information and carefully review the requirements of 35 205 Say on your applic
135. tory Guide 10 8Guide for the Preparatio Page 55 of 83 Phosphorus 32 or Gold 198 Exhibit 17 or your own nursing instruction form as an outline Allow time for questions and answers during the briefing Leave a written copy of the radiation safety precautions in the patient s chart or at the nurses station 6 Brief the patient on radiation safety procedures for the dosage administration visitor control urine collection radioactive waste and other items as applicable 7 Only those persons needed for medical safety or training purposes should be present during the administration Mark a visitors safe line on the floor with tape as far from the patient as possible 9 Following administration of the dosage measure the exposure rate in mR hr at bedside at 1 meter from bedside at the visitors safe line and in the surrounding hallways and rooms the last rates must conform to requirements in paragraph 20 105 b Record this and any other necessary information on the nursing instructions form or the nurses dosimeter signout form Post the room with a Radioactive Materials sign 10 For patients treated with liquid or gelatin capsuled I 131 1 day after the dosage administration measure the thyroid burden of all personnel who were present for the administration Also consider a thyroid burden assay for patient care personnel 2 days after the administration Make a record of the worker s name amount of I 131 activity in a thyroid
136. unt them to ensure that every source removed has been returned Then make a record of the number and activity of sources returned the room number of use or patient s name and the time and date they were returned to storage initial the record 7 If you ever perceive a discrepancy between the record and the number of sources in use and in storage notify the RSO immediately See Exhibit 15 for a sample form you may want to use APPENDIX N Model Procedure for Area Surveys See 35 70 You may use the following model procedure to perform area surveys If you follow the model procedure you may say on your application We will establish and implement the model procedure for area surveys that was published in Appendix N to Regulatory Guide 10 8 Revision 2 You may develop your own procedure for review If you do so you should consider for inclusion all the features in the model procedure and carefully review the requirements of 35 70 Say on your application We have developed survey procedures for your review that are appended as ATT 10 12 and append your survey procedures MODEL PROCEDURE Ambient Dose Rate Surveys 1 Survey Areas a In radiopharmaceutical elution preparation and administration areas survey at the end of each day of use with a radiation detection survey meter If diagnostic administrations are occasionally made in patients rooms and special care is taken to remove all paraphernalia those rooms need not be surve
137. uries as recorded on the unit dosage or packing slip and its associated time Date of administration or disposal If administered a Prescribed dosage unless already recorded in clinical procedure manual b Measured activity in millicuries or microcuries and date and time of measurement C Patient name and identification number if one has been assigned 9 If discarded the date and method of disposal and 10 Initials of the individual who made the record GO Os See Exhibit 13 for a Unit Dosage Receipt and Use Log Form you may want to use M 2 Records of Multidose Vial Use 30 51 35 21 35 53 You may use the following model procedure to keep a record of multidose vial use If you will follow the model procedure you may say on your application We will establish and implement the model procedure for a multidose vial record system that was published in Appendix M 2 to Regulatory Guide 10 8 Revision 2 If you prefer you may develop your own multidose vial record system for review If you do so you should consider for inclusion all the features in the model system and carefully review the requirements of 30 51 35 21 and 35 53 Say on your application We have developed a procedure for a multidose vial record system for your review that is appended as ATT 10 9 and append your multidose vial record procedure MODEL PROCEDURE For each multidose vial that you receive from a supplier or that you prepare make a record o
138. use Material may not be used if the survey meter is not working There is no need to keep a record of these checks Camera 1 Perform the following checks daily at each location of use before administering byproduct material a Peak each camera according to the manufacturer s instructions b Using either Tc 99m or Co 57 perform an extrinsic flood field with a frequently used collimator in place or perform an intrinsic flood field test Accumulate at least 1 000 000 counts for small field of view cameras and 3 000 000 counts for large field of view cameras Process the image as if it were an image of a patient c Do not administer material until an authorized user or a designated technologist approves the camera for use d You do not have to make a permanent record of these daily checks 2 Perform the following checks weekly a With the same frequently used collimator in place image a flood source and either a parallel line equal space PLES bar orthogonal hole OH or resolution quadrant phantom with the flood field as a source b If a PLES or bar phantom is used rotate it 90 so that the camera is tested for both vertical and horizontal geometric linearity c If a resolution quadrant phantom is used rotate it so that each quadrant is imaged in each quadrant of the crystal Then turn it over and again image it four more times This procedure will check both resolution and horizontal and vertical geometric linearity in each http
139. weekly for contamination If necessary decontaminate or secure the area for decay http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 38 of 83 12 With a radiation detection survey meter survey the generator storage kit preparation and injection areas daily for contamination If necessary decontaminate or secure the area for decay as appropriate 13 Confine radioactive solutions in shielded containers that are clearly labeled Radiopharmaceutical multidose diagnostic vials and therapy vials should be labeled with the isotope the name of the compound and the date and time of receipt or preparation A log book should be used to record the preceding information and total prepared activity specific activity as mCi cc at a specified time total volume prepared total volume remaining the measured activity of each patient dosage and any other appropriate information Syringes and unit dosages should be labeled with the radiopharmaceutical name or abbreviation type of study or the patient s name 14 Assay each patient dosage in the dose calibrator before administering it Do not use a dosage if it is more than 10 percent off from the prescribed dosage except for prescribed dosages of less than 10 microcuries When measuring the dosage you need not consider the radioactivity that adheres to the syringe wall or remains in the needle Check the patient s name and identification number and the pr
140. y Sealed Source Quarterly Inventory and Survey 3 23 Leak Test Records 3 30 Room Survey Sets for Future Use 3 41 Annual Sink Disposal Summary 3 42 Annual Vent Disposal Summary 3 43 Hot Lab Sink Disposal Logs 3 44 Research Lab Sink Disposal Logs 3 45 Decay In Storage Release Logs etc Section 4 Contract Services 4 1 Personal Dosimetry Service Contract 4 2 Change Forms 4 3 Monthly Exposure Reports 4 4 Waste Shipment Contract 4 5 Transfers of Byproduct Material etc Section 5 Training Lecture Outlines Handouts and Attendance Logs 5 11 Nonradiology Physicians 5 12 Nonradiology Technologists 5 21 Radiology Physicians 5 22 Radiology Technologists 5 31 Administrators 5 32 Security http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio 5 33 5 34 5 35 5 41 5 42 5 43 5 51 5 52 5 53 5 54 5 61 Page 69 of 83 Physical Plant Housekeeping Animal Research Facility Nursing General Radiation Safety Nursing for Brachytherapy Nursing for Iodine Therapy Brachytherapy Team Diagnostic Nuclear Medicine Personnel Therapeutic Nuclear Medicine Personnel Teletherapy Personnel In Vitro Users etc Section 6 Radiation Safety Equipment on Hand Set up an individual file for each piece of equipment The file should contain the user s manual guarantee service reports and calibration reports File alphabetically by manufacturer Section 7 Incidents 7 1 7 2 7 3
141. y reduce the downwind effluent concentration because it is primarily a function of the natural dispersion in the atmosphere ga rmoaQaao 0 2 MODEL PROCEDURE FOR CALCULATING AIRBORNE EFFLUENT CONCENTRATION 1 Divide the total activity released to an unrestricted area activity used each week that is released in an exhaust system by the total http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 52 of 83 volume of air exhausted over the week on time multiplied by measured airflow rate The quotient must be less than the applicable maximum permissible value for an unrestricted area 2 If this is not the case plan for fewer studies and do the calculation again Alternatively you may consider collection and decay in storage for waste or restriction of access to the release point and calculation of concentration at the boundary of the restricted area 0 3 MODEL PROCEDURE FOR MONITORING OR CHECKING TRAP EFFLUENT Charcoal traps can significantly reduce air contamination They can also become saturated or be spoiled by improper use humidity chemicals or inadequate maintenance 1 If the trap effluent is monitored by a radiation detector designed to monitor effluent gas check the detector according to the manufacturer s instructions and keep a record of the checks 2 If you do not monitor the trap effluent check it on receipt and once each month Collect the effluent from the trap duri
142. yed b In laboratory areas where only small quantities of gamma emitting radioactive material are processed less than 200 microcuries at a time survey monthly with a radiation detection survey meter c In radiopharmaceutical storage and radiopharmaceutical waste storage areas survey weekly with a radiation detection survey meter d In sealed source and brachytherapy storage areas survey quarterly with a radiation measurement survey meter 2 Immediately notify the RSO if you find unexpectedly high or low levels Removable Contamination Surveys 1 Survey Areas http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 49 of 83 a In radiopharmaceutical elution preparation and administration areas survey weekly for removable contamination If diagnostic administrations are occasionally made in patients rooms and special care is taken to remove all paraphernalia those rooms need not be surveyed b In laboratory areas where only small quantities of photon emitting radioactive material are processed less than 200 microcuries at a time survey monthly for removable contamination c In radiopharmaceutical storage and radiopharmaceutical waste storage areas survey weekly for removable contamination 2 The wipe sample assay procedure should be sufficiently sensitive to detect the presence of 2000 dpm 100 cm of removable contamination 200 dpm 100 cm for isotopes of iodine You must use a ra
143. ysis procedure for all wipe samples f If the wipe sample activity is 0 005 microcurie or greater notify the RSO The source must be withdrawn from use to be repaired or discarded If it is a source distributed under an NRC or Agreement State license the NRC must be notified See paragraph 21 21 b http www nrc gov NRC RG 10 10 008r2 html 11 24 99 Regulatory Guide 10 8Guide for the Preparatio Page 37 of 83 of 10 CFR Part 21 and paragraph 35 59 e 2 of 10 CFR Part 35 g Sign and date the list of sources data and calculations APPENDIX I Model Rules for Safe Use of Radiopharmaceuticals See 35 21 You may use the following model rules as they appear here saying on your application We will establish and implement the model safety rules published in Appendix I to Regulatory Guide 10 8 Revision 2 If you prefer you may develop your own rules for safe use of radiopharmaceuticals for review If you do so you should consider for inclusion all the items in the model rules and carefully review the requirements of Part 35 Say on your application We have developed rules for the safe use of radiopharmaceuticals for your review that are appended as ATT 10 4 and append your model rules for the safe use of radiopharmaceuticals MODEL RULES 1 Wear laboratory coats or other protective clothing at all times in areas where radioactive materials are used 2 Wear disposable gloves at all times while handling radioactive mater
144. zed user will ensure that supervised individuals who are subject to occupational radiation exposure are trained and educated in good health physics practices and in maintaining exposures ALARA 5 Individuals Who Receive Occupational Radiation Doses a b Workers will be instructed in the ALARA concept and its relationship to work procedures and work conditions Workers will be instructed in recourses available if they feel that ALARA is not being promoted on the job 6 Establishment of Investigational Levels in Order to Monitor Individual Occupational External Radiation Doses This institution hereby establishes investigational levels for occupational external radiation doses which when exceeded will initiate review or investigation by the RSC and or the RSO The investigational levels that we have adopted are listed in Table 1 These levels apply to the exposure of individual workers The RSO will review and record on Form NRC 5 Current Occupational External Radiation Exposures or an equivalent form e g dosimeter processor s report results of personnel monitoring not less than once in any calendar quarter as required by 20 401 of 10 CFR Part 20 The following actions will be taken at the investigational levels as stated in Table 1 a Personnel dose less than Investigational Level I Except when deemed appropriate by the RSO no further action will be taken in those cases where an individual s dose is less than Table 1 values

Guide for the Preparation of Applications for Medical Use Programs

Contents

Download Pdf Manuals

Related Search

Related Contents