radiation safety manual - new york medical college · pdf file ·...

Radiation Safety Manual New York Medical College

C. Andrew Powers, Ph.D.

Chairperson Radiation Safety Committee

Matty H. Mozzor, RRPT Radiation Safety Officer

MAY 2002

Table of Contents

1. Radiation Safety Committee

1.1. Purpose 1.2. Organization 1.3. Responsibilities

2. Radiation Safety Officer

2.1. Authority 2.2. Qualifications 2.3. Organization 2.4. Functions

3. Radiation Safety Office

3.1. Purpose 3.2. Functions

4. Responsibilities of New York Medical College Personnel

4.1. Government Regulations 4.2. Institute Regulations

4.3. Responsibility of Approved Users 4.4. Responsibility of the Individual User of Radioisotopes

5. Procurement of Authorization to Use Radioisotopes

5.1. General Information 5.2. Application for a Radioisotope Permit for Non-Human Use 5.3. Application for a Radioisotope Permit for Human Use 5.4. Special Requirements or Recommendations of the Committee 5.5. Distribution of Codes, Procedures, and Pertinent Literature

6. Procurement of Radioactive Materials

6.1. Requisitions 6.2. Order Placement 6.3. Purchase Approval and Billing 6.4. Notice of Arrival 6.5. Delivery Point 6.6. Delivery Hours

7. Rules for the Safe Handling of Radioactive Materials

7.1. General Considerations 7.2. Rules for Safe Handling of Radioactive Material 7.3. Transportation of Radioisotopes 7.4. Radioactive Materials Inventory 7.5. Monitoring Equipment

8. Animals Containing Radioactive Materials 8.1. Injection of Animals with Radioactive Materials 8.2. Housing of Animals Containing Radioactive Materials 8.3. Animal Excreta 8.4. Disposal of Animals Containing Radioactive Materials 9. Personnel Training Program

9.1 General Requirements 9.2 Requirement for Instruction 9.3 Training Topics 9.4 Required Records

10. Procedure for Safely Opening Packages Containing Radioactive Materials

10.1 General Requirements 10.2 Special Requirements 10.3 Standard Procedure 10.4 Record Requirements

11. Declaration of Pregnancy

11.1 Introduction 11.2 Procedure

12. Program for Maintaining Occupational Radiation Exposures As Low As Reasonably Achievable.

12.1 Management Commitment 12.2 Radiation Safety Committee 12.3 Radiation Safety Officer 12.4 Authorized Users 12.5 Persons Who Receive Occupational Radiation Exposure 12.6 Establishment of Investigational Levels in Order to Monitor Individual

Occupational External Radiation Exposures 13. Personnel External Exposure Monitoring Program

13.1 General Considerations 13.2 Conditions Requiring Individual Monitoring of External Dose 13.3 Conditions Requiring Individual Monitoring of Internal Dose 13.4 Proper Wearing of personnel Monitoring Devices

14. Radiation Dose Limits

14.1 General Considerations 14.2 Occupational Dose Limits (Annual) 14.3 Dose Limits for the Embryo and Fetus 14.4 Radiation Dose Limits for Individual Members of the Public 14.5 Occupational Dose Limits for Minors

15. Radioactive Material Spill Procedures

15.1 General Considerations 15.2 Minor Spills (< 1.0 millicuries) 15.3 Major Spills (> 1.0 millicuries)

16. Procedures for Calibrating Survey Meters

16.1 General Considerations 16.2 Procedure 16.3 Calibration Report 16.4 Survey Meter Calibration Sticker

17. Procedure for Leak-Testing Sealed Sources

17.1 General Considerations 17.2 Exemption from Leak-testing Requirement 17.3 Procedure

18. Procedures for Radioactive Waste Disposal

18.1 Introduction 18.2 General Guidance 18.3 Discharge of Radioactive Material to the atmosphere 18.4 Release of radioactive material to the sanitary sewer 18.5 Decay-In-Storage 18.6 Procedure for transfer for burial 18.7 Return of radioactive material to manufacturer 18.8 Disposal of Exempt waste

19. Radiation Surveys 19.1 General Requirements 19.2 Removable Contamination Surveys 19.3 Ambient Exposure Rate Surveys 19.4 Survey Records 20. Requirements for Radioactive Material Use Areas 20.1 General Considerations 20.2 Hoods 20.3 Classification of Areas 20.4 Posting of Areas and Other Required Labels 20.5 Storage of radioactive Materials 20.6 Design of New Facilities 20.7 Vacating Facilities 20.8 Contamination Levels 21. Appendices

Appendix 1 Monitoring Device Request Form

Appendix 2 Radioactive Material Utilization Log

Appendix 3 Wipe Test Worksheet

Appendix 4 Ambient Survey Worksheet

Appendix 5 Application for Permit to Use Radioactive Material

Appendix 6 Report of Past Exposure Form

Appendix 7 Radioactive Package Receipt and Monitor Log

Appendix 8 Report of Thyroid Bioassay

Appendix 9 Radioactive Waste Storage Log

Appendix 10 Notice To Employees Appendix 11 Declaration of Pregnancy Form

Appendix 12 Radiation Safety Audit Form

22. Tables

Table 1 Effluent Concentrations in Air

Table 2 Concentrations of Radionuclides in the Sanitary Sewer

Table 3 Maximum Allowable Monthly Activity in the Sanitary Sewer Table 4 Quantities of Radioactive Materials Requiring Labeling

Table 5 Radiation Safety Committee Membership

1. Radiation Safety Committee 1.1. The Purpose of the Radiation Safety Committee

The purpose of the Radiation Safety Committee is to promote the best practice in safe handling and use of radioactive sources within the jurisdiction of New York Medical College. Its services are available to all users. The establishment of a Radiation Safety Committee is required by the New York State Department of Health before an institutional program for the use of radioactive materials can be licensed. Government regulations concerning radioactive materials are implemented by the action of the Committee in association with individual radioactive material users.

1.2. Organization of the Radiation Safety Committee

The Radiation Safety Committee, appointed by the Dean of New York Medical College, is made up of a minimum of 8 members of the College faculty including one representative each from the Departments of Biochemistry, Cell Biology and Anatomy, Microbiology, Pathology, Pharmacology, Physiology, Comparative Medicine, Security, Administration, the Nuclear Medicine Section of the Department of Radiology, and the Radiation Safety Officer who is a physicist experienced in assay of radioactive materials and protection against ionizing radiation. Ex-officio members Committee include the Dean of New York Medical College

The activities of the Radiation Safety Committee are directed by a Chair-person. The Chairman is appointed by the Dean of the New York Medical College. The Radiation Safety Officer, appointed by the Dean, serves as Executive Secretary of the Radioactive material Committee and conducts its activities in the absence of the Chairman.

Meetings of the Radiation Safety Committee shall be held quarterly or on petition of a member of the Committee. Minutes of all meetings shall be kept. The Chair-person of the Committee shall conduct interim business of the Committee. A quorum shall consist of one half of the committee's membership, including the Radiation Safety Officer and the management representative.

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1.3. Responsibilities of the Radiation Safety Committee The Radiation Safety Committee shall:

1) Be familiar with all pertinent New York State Department of Health regulations, the terms of the New York Medical College Radioactive Materials License, and information submitted in support of the request for the license and its amendments.

2) Review the training and experience of all individuals who use radioactive

material (including researchers and other laboratory personnel) and determine if their qualifications are sufficient to enable them to perform their duties safely and in accordance with New York State Department of Health regulations and the conditions of the radioactive material license.

3) Be responsible for monitoring the institution's program to maintain

individual and collective doses as low as reasonably achievable.

4) Review quarterly, with the assistance of the Radiation Safety Officer, occupational radiation exposure records of all personnel working with radioactive materials.

5) Establish a table of investigation levels for occupational radiation

exposure, which when exceeded, will initiate an investigation and consideration of action by the Radiation Safety Officer.

6) Establish a program to ensure that all individuals whose duties may

require them to work in the vicinity of radioactive materials (i.e. security and housekeeping personnel) are properly instructed as required by Section 16.13 of 10NYCRR 16.

7) Review and approve all requests for use of radioactive material within

New York Medical College.

8) Prescribe special conditions that will be required during a proposed use of radioactive material such as requirements for bioassays, physical examinations of users, and special monitoring procedures.

9) Review the entire radiation safety program at least annually to determine

that all activities are being conducted safely and in accordance with New York State Department of Health regulations and the conditions of the radioactive materials license. The review shall include an examination of all records, reports from the Radiation Safety Officer, results of New York State Health Department inspection, written safety procedures, and the adequacy of the institution's management control system.

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10) Recommend remedial action to correct any deficiencies identified in the radiation safety program.

11) Maintain written records of all Committee meetings, actions,

recommendations, and decisions.

12) Ensure that the radioactive materials license is amended prior to any change in facilities, equipment, policies, procedures, radioactive materials, possession limits, and personnel, as specified in the license.

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2. The Radiation Safety Officer 2.1. Authority

The Radiation Safety Officer is appointed by the Dean of New York Medical College. The Radiation Safety Officer is the authorized representative of the Radiation Safety Committee regarding measures to implement radiation protection and control within New York Medical College. The Radiation Safety Officer manages the day-to day activities of all aspects of the Radiation Safety program.

2.2 Qualifications

An individual fulfilling the responsibilities of the Radiation Safety Officer shall: a. Be certified by:

1) American Board of Health Physics in Comprehensive Health Physics; or

2) American Board of Radiology in Radiological Physics; or 3) American Board of Nuclear Medicine; or 4) American Board of Science in Nuclear Medicine; or 5) Board of Pharmaceutical Specialties in Nuclear Pharmacy; or

b. Hold a bachelor's degree in a physical science and have had 200 hours of

classroom and laboratory training as follows:

1) radiation physics and instrumentation; 2) radiation protection; 3) mathematics pertaining to the use and measurement of radioactivity; 4) radiation biology; 5) radiation chemistry; and 6) two years of full-time experience in radiation safety at a medical

institution under the supervision of the Radiation Safety Officer; or 7) Be certified by the National Registry For Radiation Protection

Technologists

c. Be an authorized user for those radioactive materials that come within the Radiation Safety Officer’s responsibilities identified on the radioactive materials license.

2.3. Organization

The Radiation Safety Officer is a physicist who is experienced in the assay of radionuclides and protection against ionizing radiation.

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2.4. Functions

The duties of the Radiation Safety Officer regarding radioisotopes include the following:

a. Provide consulting services on all aspects of radiation protection and

radioisotope and radiation use.

b. Maintain radiation exposures at the lowest possible level by the supervision or operation of an effective and appropriate radiation protection and control program.

c. Develop and maintain a procedure for keeping personnel exposure and

contamination records.

d. Indoctrinate personnel in the proper procedures to be used, and the equipment necessary for the safe use of radioisotopes.

e. Provide assurance that the waste disposal program and the records

associated with waste disposal are appropriate and accordance with regulations.

f. Supervise periodic leak testing of sealed radioactive sources.

g. Supervise a continuous program of area and environmental radiation hazard analysis.

h. Ensure maintenance of records of radioisotope procurement and

distribution within the College.

i. Furnish all authorized users of radioisotopes a copy of the "Radiation Safety Manual" and inform them of relevant sections of the State Regulations.

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3. Radiation Safety Office 3.1. Purpose

The Radiation Safety Office has been established to assist the Radiation Safety Officer in his duties. It is operated on a full time basis by the Radiation Safety Officer with the assistance of the Radiation Safety Specialist.

3.2. Functions

The functions of the Radiation Safety Office regarding radioisotopes are to:

a. Receive all purchase orders for radioactive materials for the College; place the order with the appropriate vendor; and forward them to the Purchasing Department of New York Medical College.

b. Coordinate the receipt of all radioisotope shipments and to direct delivery

to the appropriate user.

c. Supervise the collection and removal of radioactive wastes from New York Medical College

d. Supply personnel monitoring equipment to personnel working with

radioactive materials.

e. Conduct periodic inspections of all areas where radioactive materials are used and/or stored.

f. Maintain records of personnel monitoring; radioactive materials

procurement and disposal; and radiation surveys.

g. Provide radiation safety and radiation use consultations as needed.

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4. Responsibilities of New York Medical College Personnel 4.1. Government Regulations

Radioactive material may be used only under specific licenses issued by the New York State Department of Health. New York State licensing is required for activities utilizing radioactive materials at all the Valhalla facilities. The regulations covering the procurement of licenses are published in the New York State Sanitary Code, Chapter 1,Part 16, "Ionizing Radiation". Copies of these regulations are available in the Radiation Safety Office. All licenses of the New York State Department of Health are required to conform with standards for protection against radiation hazards. These standards are published in Part 16 of the N.Y. State Sanitary Code.

4.2. New York Medical College Regulations

No person may use within, or bring into New York Medical College any radioisotope in any amounts without authorization from the Radioisotope Committee. The authorization will be issued in a letter from the Radiation Safety Committee.

4.3. Responsibility of Approved Users

Those persons who are approved to use radioisotopes are responsible for the safe handling of radioactive materials by individuals under their control.

These persons are responsible for:

a. Compliance with the New York Medical College Radiation Safety Manual

and the New York State Department of Health Regulations;

b. Day-to-day supervision of employees under their control in the use of safety devices and procedures;

c. Adequate planning of an experiment, or procedure, to assure that proper

safety precautions are taken;

d. Communication of pertinent information regarding changes in operational procedures, especially those new techniques that could lead to increased exposures to laboratory personnel or increased contamination levels in the laboratory or the environs;

e. Direction of personnel under their control to comply with all

recommendations to wear monitoring devices and to perform surveys of their hands and clothing. They shall also direct personnel under their control to submit to bioassay procedures when it is deemed by the

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Radiation Safety Officer to be necessary. These bioassay procedures may be performed prior to the initial handling of radioactive materials; in the event of extended leave or resignation from New York Medical College; and at other times as indicated.

4.4. Responsibility of the Individual User of Radioisotopes

Each person at New York Medical College who has any contact with sources of ionizing radiation has a responsibility to:

a. Keep his/her exposure to radiation at the lowest possible level,

specifically below the maximum permissible exposure as stated in this manual;

b. Wear the recommended radiation detectors for personnel, such as

monitoring devices and pocket ionization chambers;

c. Survey his hands, shoes, body and clothing for radioactivity and remove all loose contamination before leaving the laboratory particularly after the use of radioactivity at levels above those stipulated in this manual;

d. Use all recommended protective measures such as protective

clothing, respiratory protection, remote pipetting devices, ventilated and shielded glove boxes and hoods;

e. Not smoke, eat, drink or apply cosmetics in radioisotope

laboratories;

f. Check his/her working area for contamination periodically or after each radioisotope procedure in conformity with procedures set forth in this manual;

g. Maintain good housekeeping practices in the laboratories;

h. Label radiation equipment and segregate radiation waste and equipment to avoid cross contamination;

i. Report immediately to the Radiation Safety Officer the details of a

spill or other accident involving radioactivity;

j. Conduct decontamination procedures as necessary.

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5. Procurement of Authorization to Use Radioactive Materials 5.1. General Information

The Radiation Safety Committee has obtained in the name of the New York Medical College, a Broad Non-Human Use license from the New York State Department of Health for the use of radioactive materials. Licenses for human use are requested by the College for specific uses only. The Radiation Safety Committee is empowered to recommend to the Dean that internal authorization be granted to responsible users of radioactive materials in accordance with the above licenses. The Committee requires the completion and approval of the Application for Permit to Use Radioactive Isotopes before authorization to use radioactive material can be recommended. The application may be found in Appendix 5 in the back of this manual.

5.2. Application for a Radioisotopes Permit for Non-Human Use

An intending user of radioactive materials for non-human use (biological, chemical or physical) must demonstrate to the Committee adequate training in, and facilities for, the safe use of these materials. The following procedure has been adopted in the issuance of permits:

a. The applicant shall send to the Chairman of the Radiation Safety

Committee a completed copy of the New York Medical College application form.

b. After initial review by the Chairman and the Radiation Safety Officer, the

application will ordinarily be considered at the next meeting of the Committee.

c. If approved by the Committee, authorization, signed by the Chairman of

the Radiation Safety Committee, shall be issued to the applicant.

d. The authorized user will be issued a Radioactive Material Permit. This permit shall specify the following information:

• The name of the authorized user • The room number(s) where the radioactive material will be stored or

processed • The specific radionuclides authorized under the permit • The maximum possession limits for each radionuclide • The expiration date of the permit This permit must be displayed prominently on or close to the door of the room(s) where the radioactive material is to be stored or processed. The

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permit must be oriented in such a manner so that it can be read without entering the room(s).

5.3. Application for a Radioisotopes Permit for Human Use

The general requirements for authorization to administer radioactive materials to humans are more restrictive than the requirements for a non-human use permit. The prerequisites are:

a. The user must be a physician licensed in New York State to dispense

drugs in the practice of medicine.

b. The physician must have basic radioisotope training and, for certain common procedures, must have participated actively in the use of radioisotopes.

The following procedure has been adopted in the issuance of authorization for human use:

a. The applicant shall send to the Chairman of the Radiation Safety

Committee three copies of each of the following forms: i. New York Medical College Radiation Safety Committee form. ii. State of New York Application for Radioactive Materials License.

iii. For non-routine human use only, an outline of the required research protocol.

b. After initial review by the Chairman and the Radiation Safety Officer, the

application will ordinarily be considered at the next meeting of the Committee.

c. If approved by the Committee, the applicant shall be notified by letter

from the Chairman of the Radiation Safety Committee. 5.4. Special Requirements or Recommendations of the Committee

If deemed appropriate, special requirements or recommendations regarding surveys, assays, waste disposal, storage of material, protective devices, etc. may be made by the Committee and incorporated in the permit.

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5.5. Distribution of Codes, Procedures, and Pertinent Literature

The Radiation Safety Office shall make available to each approved applicant copies of the following as appropriate:

a. The New York State Sanitary Code - Part 16. b. The New York State "Notice to Employees". c. Handling procedures. d. Emergency procedures. e. Pertinent handbooks and literature. The "Notice to Employees" and handling and emergency procedures are to be conspicuously posted in the controlled areas when radioactive materials are on hand.

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6. Procurement of Radioactive Materials 6.1. Requisitions

The Radiation Safety Office must process all requests for radioactive materials. Individual users are forbidden from placing their own orders. A properly completed requisition should contain the following information:

a. Supplier. b. Amount and chemical form of radionuclide. c. Catalogue number. d. Date needed. e. Account or grant number to be charged (NYMC). f. Total cost, handling, etc. g. Delivery point (see Item 6.5 below).

6.2 Order Placement

Forward the completed copy of the requisition to the Radiation Safety Office, where it will be reviewed and processed.

6.3 Purchase Approval and Billing

The Radiation Safety Office will verify the order against the current permit, review it for completeness and accuracy and then will place the order. The Purchasing Office will not place an order for radioactive materials. After the order is placed, the requisition will be forwarded to the Purchasing Department. The Purchasing Department will directly charge the appropriate department or grant.

6.4 Notice of Arrival

Shipments of radioactive materials will be received by the Radiation Safety Office at the locations listed in section 6.5. Notification of arrivals will be made to the departments.

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6.5 Delivery Point

The following delivery points are the only authorized locations for receipt of radioactive materials:

a. Basic Sciences Building

b Munger Pavilion c Vosburgh Pavilion

d. Macy Pavilion e. 4 Skyline Drive

f. 19 Bradhurst Road

The deliveries will be made to the rooms indicated on the purchase requisition. 6.6 Delivery Hours

Delivery of radioactive material will only be accepted between the hours of 8 A.M. through 4 P.M. Monday through Friday. For delivery at other times, special arrangements must be made with the Radiation Safety Office prior to delivery.

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7. Rules for the Safe Handling of Radioactive Materials 7.1 General Considerations

Before any work is undertaken with radioactive material attention shall be given by the user to precautionary measures including the use of hoods, remote handling equipment, air monitoring, etc. The Radiation Safety Officer should be consulted for recommendations on initial or unusual operations. All individuals working with or in the vicinity of radioactive materials or radiation producing equipment must first attend the radiation safety training class.

7.2 Rules for Safe Handling of Radioactive Material

The following rules shall be obeyed in any laboratory using radioactive materials:

a. Work that may result in contamination of work surfaces shall be done over plastic-backed absorbent paper. Trays made of impervious materials (i.e., stainless steel) and lined with absorbent paper provide excellent work arrangements to help prevent the spread of contamination.

b. Personnel working in areas containing radioactive materials shall wash

their hands thoroughly, using plenty of soap, before eating, smoking, applying cosmetics or leaving work. Those working with unsealed sources should monitor hands and shoes upon completing operations.

c. Eating, storing or preparation of food and application of cosmetics is

forbidden in a laboratory or rooms where work with unsealed radioactive sources is taking place or where contamination may exist.

d. Smoking is not permitted in areas where work with unsealed radioactive

sources is in progress or where contamination may exist. Under no circumstances should cigarettes, cigars or pipes be laid on tables or benches where radioactive work has been or is in progress.

e. Pipetting by mouth of radioactive solutions is forbidden.

f. Segregate pipetting devices used with radioactive materials from those used with non-radioactive materials

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g. Impervious gloves shall be worn during operations involving the handling of radioactive material. The gloves should be removed before leaving the laboratory. Care must be taken such that other items (e.g., pens, pencils, notebooks, doorknobs, telephones, keyboards, etc.) are not handled with gloves during work with radioactive materials.

h. Laboratory coats shall be worn by all individuals working in areas where

radioactive material is handled. The laboratory coat should be removed before leaving the isotope laboratory and kept in the laboratory.

i. Where contamination is noted during a laboratory survey, or there has

been a spill of radioactive material that may have produced contamination of a person or clothing, both the person and the clothing shall be monitored. Personal contamination should be removed as soon as possible. Clothing which shows contamination producing surface count-rates on a thin window Geiger-Muller survey meter of less than 200 cpm may be released (and laundered). Clothing showing higher count-rates shall either be stored until the count rate is less than 200 cpm, laundered by an approved decontamination laundry or be disposed of through a commercial disposal company, at the discretion of the Radiation Safety Officer.

j. Work surfaces and personnel shall be monitored after working with

radioactive materials. k. Objects and equipment that may have been contaminated with radioactive

material shall be surveyed and demonstrated to be free of contamination prior to their removal from a laboratory, or transferred to other laboratories, repair shops, surplus, etc. If found to be contaminated, such items must be decontaminated as soon as practical.

l. If personnel monitoring devices (whole-body or ring badge) have been

issued to you for your work with radioactive material, they must be worn at all times when in areas where these materials are used or stored. These devices should be worn as prescribed by the Radiation Safety Officer.

m. Dispose of radioactive material only in the manner designated by the

Radiation Safety Officer, and maintain records as instructed. n. Store radioactive materials in covered containers plainly identified and

labeled with name of compound, radionuclide, date, activity, and radiation level, if applicable.

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7.3 Transportation of Radioisotopes

Special permission is required for researchers who wish to transport radioisotopes from the Valhalla Campus to other institutions or who wish to receive radioisotopes from another institution. The Radiation Safety Office must be consulted before any extramural transportation of radioisotopes can occur. Transportation of radioisotopes between buildings on the New York Medical College Campus may be performed without special permission provided the following criteria are met:

a. The area where the radioactive material is being transferred to is listed on

the authorized users radioactive material permit. b. Radioisotopes requiring a "Radioactive Materials" label must be enclosed

in non-shatterable carrying cases or containers, preferably metallic, before being transported through corridors or between buildings.

c. Containers for the transportation of beta sources requiring a "Radioactive

Materials" label must provide shielding thicker than the maximum range of the beta rays and be sufficient to absorb the bremsstrahlung radiation. The Radiation Safety Officer will assist in determining proper transport containers.

d. Gamma-ray emitters shall be transported in closed containers, shielded if

necessary, such that the dose-rate at the surface does not exceed 200 mrem per hour, and the dose-rate at one meter does not exceed 10 mrem per hour. (This rule follows the I.C.C. shipping regulations.)

7.4 Radioactive Materials Inventory

It is the responsibility of each investigator to maintain an inventory of all radioactive materials received, processed and disposed of in their laboratories. This should be recorded in the Radioactive Material Utilization Log (Appendix 2).

7.5 Monitoring Equipment

Each investigator employing radioactive material shall have a low level survey meter, with a thin window of about 2 mg/cm2, capable of detecting 0.1 milliroentgen per hour to perform contamination surveys. This meter should have an audio function. It shall be the responsibility of the investigator to arrange calibration of this equipment at least annually.

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8. Animals Containing Radioactive Materials 8.1. Injection of Animals with Radioactive Materials

Injection of radioactive materials into animals shall be carried out on stainless steel trays having absorbent materials in the bottom. Rubber surgical gloves or disposable plastic gloves shall be worn by the worker for all levels of radioactivity requiring a radioactive materials sign.

8.2. Housing of Animals Containing Radioactive Materials

Animals containing radioactive materials must be kept in the special room set aside for this purpose in the Animal Quarters. Arrangements for use of the room shall be made through the Director of Animal Care. If there is strong justification a permit holder may request a waiver of this requirement from the Radiation Safety Committee. Permission will be granted only if it has been demonstrated that proper care will be taken in the handling of excreta and monitoring of personnel.

All cages housing animals injected with radioactive material shall be clearly marked as follows:

a. Name of radioisotope. b. Amount of radioactive material injected per animal. c. Date of injection. d. Principal investigator's name. e. "Caution Radioactive Material" tape must be affixed to the cage.

Adequate ventilation or air cleaning must be provided in instances where animals are stored after an injection of radioactive materials that may be volatilized and dispersed in the room.

8.3. Animal Excreta

All animal excreta which may contain radioactivity shall be collected, and if necessary, stored before disposal. It may be disposed of through the sewage system if the excreta is in a suitable form, i.e., not mixed with sawdust or wood shavings, and if it meets the limits specified in Section 18 Radioactive Waste Disposal.

If the excreta shows no activity above background when monitored by a survey meter, a meter appropriate to the radioisotope involved, it may be discarded with normal trash in a suitable container.

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In all other cases the excreta shall be labeled with the name of the radionuclide and the estimated amount of activity, and or stored prior to shipment via a commercial disposal company, in accordance with the rules for disposal

8.4. Disposal of Animals Containing Radioactive Materials

The carcasses or dissected parts of injected animals shall be wrapped in absorbent material and placed in the special radioactive waste container to await commercial disposal. If a carcass has a concentration of H-3 or C-14 less than 0.05 µCi per gram of anatomical tissue it is possible to discard the carcass as non-radioactive waste.

Animals awaiting disposal shall be placed in a refrigerator (or preservative). The container must be properly labeled in accordance with the instructions in Section 20.4. – Posting of Areas and Other Required Labels.

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9. Personnel Training Program 9.1 General Requirements New York Medical College provides a radiation safety training program for individuals who work with or in the vicinity of radioactive materials or radiation producing equipment. It can not be assumed that safety instruction has been adequately covered by prior occupational training, board certification, etc. Also ancillary personnel (i.e. professional or nursing, 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. 9.2 Requirement for Instruction

Personnel will be instructed:

a. Before assuming duties with, or in the vicinity of, radioactive materials.

b. During periodic refresher training.

c. Whenever there is a significant change in duties, regulations, or the terms of the radioactive material license.

9.3 Training Topics For “Radioisotope Users” (including X-Ray machine users)

Instruction for individuals in attendance will include the following subjects:

1) Radioactivity and radioactive decay 2) Characteristics of radioactive decay 3) Man-made sources of radioactive decay 4) Acute effects of exposure to radiation 5) Potential hazards associated with radioactive material in each area where

the employees work. 6) Special considerations in the exposure of women of reproductive age 7) Dose equivalent limits 8) Mode of exposure – internal vs. external 9) Dose equivalents determinants 10) Basic protective measures – time, distance and shielding

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11) Basic radiation survey instrumentation – calibration and limitations 12) Radiation monitoring programs and procedures 13) Contamination control, protective clothing and equipment, workplace

design 14) Personnel decontamination 15) Warning signs, alarms 16) Responsibilities of employees and New York Medical College 17) Interaction with Radiation Safety Staff 18) Specific procedures for maintaining exposures as low as reasonably

achievable 19) Applicable regulations and license conditions.

20) Areas where radioactive material is used or stored.

21) Appropriate radiation safety procedures.

22) In-house work rules.

23) Each individual’s obligation to report unsafe conditions to the Radiation

Safety Officer.

24) Appropriate response to emergencies or unsafe conditions.

25) Worker's right to be informed of occupational radiation exposure and bioassay results.

26) Locations where the licensee has posted or made available notices, copies

of pertinent regulations, and copies of pertinent licenses and license conditions, as required by 10 NYCRR 16.13.

27) Question and answer period.

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9.4 Training Topics For “Support Personnel” (ancillary personnel)

Instruction for individuals in attendance will include the following subjects:

1) Radioactivity and radioactive decay

2) Warning Signs, Alarms 3) Responsibilities of employees and New York Medical College 4) Areas where radioactive material is used or stored.

5) Appropriate radiation safety procedures.

6) Licensee's in-house work rules.

7) Each individual’s obligation to report unsafe conditions to the Radiation

Safety Officer.

8) Appropriate response to emergencies or unsafe conditions.

9) Basic protective measures – time, distance and shielding

10) Special considerations in the exposure of women of reproductive age.

11) Question and answer period. 9.4 Required Records

Records of initial and refresher training will be maintained for inspection by the department and will include:

a. The name of the individual who conducted the training.

b. The names of the individuals who received the training.

c. The dates and duration of the training session, and

d. A list of the topics covered.

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10. Procedure for Safely Opening Packages Containing Radioactive Material 10.1 General Requirements

All shipments of radioactive material shall be processed through the Receiving Department in the Basic Sciences Building. No shipments are to be made directly to individual laboratories or offices.

10.2 Special Requirements

Special requirements will be followed for packages containing quantities of radioactive material in excess of Type A quantity limits (e.g. more than 20 curies of Mo-99 and Tc-99m or more than 3 curies of I-131, Cs-137, Ir-192, or more than 1 millicurie of Ra-226). They will be monitored for surface contamination and external radiation levels within 3 hours after receipt if received during working hours or within 18 hours if received after working hours. The Radiation Safety Office will be notified if removable contamination exceeds 0.01 µCi/100 cm2 (22,000 dpm) or if external radiation levels exceed 200 mR/hr at the package surface or 10 mR/hr at 1 meter. The Radiation Safety Office will in turn notify the New York State Department of Health

10.3 Standard Procedure

Normally, Radiation Safety Office personnel will inspect all packages prior to delivery. Initial receipt inspection may be performed by the recipient in the laboratory if special arraignments are made. Regardless of whether the package was initially inspected by Radiation Safety personnel, lab recipients should inspect the package again upon receipt.

For all packages, the following procedures for opening packages will be carried out:

a. Put on gloves to prevent hand contamination.

b. Visually inspect package for any sign of damage (i.e. wetness, crushed). If damage is noted, stop procedure and notify Radiation Safety Officer.

c. Measure exposure rate at 1 meter from package surface and at the package

surface. Record the readings. If it is higher than expected, stop and notify the Radiation Safety Officer. If the reading at 1 meter is higher than 10 mR/hr notify the Radiation Safety Officer at once.

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d. Open the package with the following precautionary steps:

1) Open the outer package (following manufacturer's directions, if supplied) and remove packing slip.

2) Open inner package and verify that contents agree with those in

packing slip.

3) Check integrity of final source container (i.e. inspect for breakage of seals or vials, loss of liquid, or discoloration of packaging material).

4) If anything is other than expected stop and notify the Radiation

Safety Officer.

e. If there is any reason to suspect contamination, wipe external surface of final source container and remove wipe to low background area. Assay the wipe for removable radioactivity in an appropriate radiation detection system. Record amount of removable radioactivity (i.e. dpm/100 cm2, etc.). Take precautions against the spread of contamination as necessary.

f. Check the user request to ensure that the material received is the material

that was ordered.

g. Monitor the packaging material and packages for contamination before discarding.

1) If contaminated, treat this material as radioactive waste.

2) If not contaminated, remove or obliterate the radiation labels before discarding in in-house trash.

10.4 Record Requirements

Maintain record of the receipt of each package on Radioactive Package Receipt and Monitor Log (Appendix 7).

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11. Declaration of Pregnancy 11.1 Introduction

The New York State Department of Health makes allowances for increased protection from ionizing radiation for pregnant workers. For pregnant personnel, the dose to the embryo/fetus may not exceed 500 millirem for the entire pregnancy and can be no greater than 50 millirem per month. It should be noted that this standard applies to the radiation dose incurred in the performance of a workers duties at the New York Medical College. It does NOT apply to doses received in conjunction with radiation exposures that are medically indicated - i.e. the pregnant worker has a chest x-ray.

11.2 Procedure

Participation in this program is not mandatory. Pregnant individuals who do not participate in the program will be held to the standard for radiation workers - a maximum dose of 5000 mrem per year. Those individuals who participate in the program must make a written declaration of pregnancy to the Radiation Safety Officer. The Declaration of Pregnancy Form (Appendix 11) must be completed and returned to the Radiation Safety Office. Please note that an approximate date of conception must be entered.

It should be noted that the pregnancy need not be medically confirmed to participate in this program. Since the declaration is voluntary the declaration may be withdrawn at the discretion of the worker. In certain situations it may be necessary to adjust working conditions so as to avoid a monthly exposure level in excess of 50 millirem per month.

Those individuals who wish to participate in the program or who require additional information should call the Radiation Safety Office. Information provided to the Radiation Safety Office with regards to pregnancy status will be maintained as confidential.

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12 Program for Maintaining Occupational Radiation Exposures As Low As Reasonably Achievable

12.1 Management Commitment

a. New York Medical College is committed to the program described in this

section for keeping exposures to radiation as low as is reasonably achievable (ALARA). In accordance with this commitment, this section shall describe the administrative organization for radiation safety at New York Medical College. The policies, procedures, and instructions described in this section are designed to foster the ALARA concept within our institution. The organization will include a Radiation Safety Committee and a Radiation Safety Officer.

b. New York Medical College will perform a formal annual review of the

radiation safety program, including ALARA considerations. This shall include reviews of operating procedures and past exposure records, inspections, etc., as well as consultations with the Radiation Safety Office.

c. New York Medical College shall institute modifications to operating and

maintenance procedures and to equipment and facilities where such modifications will reduce exposures unless the cost, in the judgement of New York Medical College, is considered to be unjustified. New York Medical College will be able to demonstrate, if necessary, that improvements have been sought, that modifications have been considered, and that they have been implemented where reasonable. Where modifications have been recommended but not implemented, we will be prepared to describe the reasons for not implementing them.

d. In addition to maintaining doses to individuals as far below the limits as

reasonably achievable, the sum of the doses received by all exposed individuals will also be maintained at the lowest practical 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.

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12.2 Radiation Safety Committee a. Review of the Proposed Users and Uses

1) The Radiation Safety Committee will thoroughly review the qualifications of each applicant with respect to the types and quantities of materials and uses for which he has applied to ensure that the applicant will be able to take appropriate measures to maintain exposure ALARA.

2) When considering a new use of radioactive material, the Radiation

Safety Committee will review the efforts of the applicant to maintain exposure ALARA. The user should have systematized procedures to ensure ALARA and shall have incorporated the use of special equipment such as syringe shields, rubber gloves, etc., in his/her proposed use.

3) The Radiation Safety Committee will ensure that the user justifies

his/her procedures and that the dose will be ALARA (individual and collective).

b. Delegation of Authority

(The judicious delegation of Radiation Safety Committee authority is essential to the enforcement of the ALARA program.)

1) The Radiation Safety Committee will delegate authority to the

Radiation Safety Officer for enforcement of the ALARA concept.

2) The Radiation Safety Committee will support the Radiation Safety Officer in those instances where it is necessary for the Radiation Safety Officer to assert his authority. Where the Radiation Safety Officer has been overruled, the Committee will record the basis for its action in the minutes of the Committee's quarterly meeting.

c. Review of the ALARA Program

1) The Radiation Safety Committee will encourage all users to review current procedures and develop new procedures as appropriate to implement the ALARA concept.

2) The Radiation Safety Committee will perform a semi-annual

review of occupational radiation exposures with particular attention to instances where investigational Levels in Table 0-1, found at the end of this section, are exceeded. The principal purpose of this review is to assess trends in occupational exposure

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as an index of the ALARA program quality and to decide if action is warranted when Investigational Levels are exceeded (see Section 6).

3) The Radiation Safety Committee will evaluate the institutions

overall efforts for maintaining exposures ALARA on an annual basis. This review will include the efforts of the RSO, authorized users, and workers, as well as management.

12.3 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 procedures may be conducted on a more frequent basis.

2) Quarterly review of occupational exposures: The RSO will review

at least quarterly the external radiation exposures of authorized users and workers to determine that their exposures are ALARA in accordance with the provisions of Section 6 of this program.

3) Quarterly review of records of radiation surveys: The RSO will

review radiation levels in unrestricted and restricted areas to determine if they were at ALARA levels during the previous quarters.

b. Education Responsibilities for ALARA Program

1) The RSO provides information to 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 Development of ALARA Procedures

Radiation workers will be given opportunities to participate in formulation of 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.

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2) The RSO will establish procedures for receiving and evaluating the

suggestions of individual workers pertaining to improving health physics practices and will encourage the use of those procedures.

12.4 Authorized Users

a. New Procedures Involving Potential Radiation Exposures 1) The authorized user will consult with, and receive the approval of,

the RSO and the RSC during the planning stage before using radioactive materials for a new procedure.

2) The RSO will evaluate all procedures before using radioactive

materials to ensure that exposures will be kept ALARA. This may be enhanced through the application of trial runs.

b. Responsibility of Authorized User to Persons Under His/Her Supervision

1) The authorized user will explain the ALARA concept and his/her commitment to maintain exposures ALARA to all persons under his/her supervision.

2) The authorized user will ensure that persons under his/her

supervision who are subject to occupational radiation exposure are trained and educated in good health physics practices and in maintaining exposures ALARA.

12.5 Persons Who Receive Occupational Radiation Exposure

a. The worker will be instructed in the ALARA concept and its relationship to working procedures and work conditions.

b. The worker will know what recourses are available if he/she feels that

ALARA is not being promoted on the job. 12.6 Establishment of Investigational Levels in Order to Monitor Individual

Occupational External Radiation Exposures.

New York Medical College hereby establishes investigational levels for occupational external radiation exposure which, when exceeded, will initiate review and/or investigation by the RSC and/or the RSO. The investigational

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levels that we have adopted are listed in the Table 1 of this section. These levels apply to the exposure of individual workers.

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Table 1 Investigational Levels (mrems per calendar quarter) Level I Level II Whole body; head and trunk; 125 375 active blood forming organs; lens of eyes; or gonads Hands and forearms; feet and 1875 5625 ankles Skin of whole body 750 2250

The Radiation Safety Officer will review and maintain records of the results of personnel monitoring. The following actions will be taken at the investigational levels as stated in Table 1.

a. Quarterly exposure of individuals less than Investigational Level I.

Except when deemed appropriate by the RSO, no further action will be taken in those cases where the individual's exposure is less than Table 1 values for the Investigational Level I.

b. Personnel exposures equal to or greater than Investigational Level I, but

less than Investigational Level II.

The RSO will review the exposure of each individual whose quarterly exposures equal or exceed Investigational Level I and will report the results of the reviews at the first RSC meeting following the quarter when the exposure was recorded. If the exposure 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, consider each exposure 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.

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c. Exposure equal to or greater than Investigational Level II.

The RSO will investigate in a timely manner the cause(s) of all personnel exposures equaling or exceeding Investigational Level II and, if warranted, will take action. A report of the investigation, actions taken, if any, and a copy of the individual's Form GEN 305 or its equivalent will be presented to the RSC at the first RSC meeting following completion of the investigation. The details of these reports will be recorded in the RSC minutes. Committee minutes will be sent to the management of New York Medical College for review. The minutes, containing details of the investigation, will be made available to Department inspectors for review at the time of the next inspection.

d. Reestablishment of an individual occupational worker's Investigational

Level II to a level above that listed in Table 1.

In cases where a worker's or a group of worker's exposures need to exceed Investigational Level II, a new, higher Investigational Level II may be established on the basis that it is consistent with good ALARA practices for that individual or group. Justification for a new Investigational Level II will be documented.

The RSC will review the justification for, and will approve, all revisions of Investigational Level II. In such cases, when the exposure equals or exceeds the newly established Investigational Level II, those actions listed in paragraph 6c. above will be followed.

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13. Personnel Exposure Monitoring Program 13.1 General Considerations

The authorized user or his/her representative makes arrangements for personnel monitoring devices through the Radiation Safety Office by request. The devices are collected and distributed on a monthly basis and returned to the Radiation Safety Office. Personnel monitoring exposure records are centrally maintained by the Radiation Safety Office. Monitoring devices may be obtained by filling out the Monitoring Device Request Form (Appendix 1) and returning it to the Radiation Safety Office.

1) The Radiation Safety Officer will promptly review all exposure reports to

look for workers or groups of workers whose exposure is unexpectedly high or low. This procedure does not apply to backup monitor records, for example, pocket ionization chambers, when the monitor of record is a film or TLD.

2) All individuals who are occupationally exposed to 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. This service must be accredited under NVLAP, which determines that a dosimetry service meets ANSI standards.

3) Other individuals who are exposed to radiation on an occasional basis

such as security personnel who deliver packages, secretarial personnel who work in research departments but do not handle radioactive material, and other workers who occasionally enter areas where radioactive material is present, will not normally be issued exposure monitors.

13.2 Conditions requiring individual monitoring of external occupational dose

New York Medical College shall monitor exposures to radiation and radioactive material at levels sufficient to demonstrate compliance with the occupational dose limits specified in the New York State Sanitary Code. As a minimum:

a. New York Medical College shall monitor occupational exposure to

radiation and shall supply and require the use of individual monitoring devices by:

1) Adults likely to receive, in one year from sources external to the

body, a dose in excess of the following limits: (i) a total effective dose equivalent equal to 0.5 rems,

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(ii) the sum of the deep-dose equivalent and the committed dose equivalent to any individual organ or tissue other than the lens of the eye being equal to 5 rems,

(iii) an eye dose equivalent of 1.5 rems, and (iv) a shallow-dose equivalent of 5 rems to the skin or to any

extremity.

2) Minors likely to receive, in 1 year from sources external to the body, a dose in excess of any of the following limits:

(i) a total effective dose equivalent equal to 0.05 rems, (ii) the sum of the deep-dose equivalent and the committed

dose equivalent to any individual organ or tissue other than the lens of the eye being equal to 0.5 rems,

(iii) an eye dose equivalent of 0.15 rems, and (iv) a shallow-dose equivalent of 0.5 rems to the skin or to any

extremity.

3) Declared pregnant women likely to receive, in 1 year from sources external to the body, a dose in excess of any of the following limits:

(i) a dose to the embryo/fetus during the entire pregnancy of a

declared pregnant worker of 0.05 rems 4) Individuals entering a high or very high radiation area. 13.3 Conditions requiring individual monitoring of internal occupational dose

The New York Medical College shall monitor the occupational intake of radioactive material by and assess the committed effective dose equivalent to:

1) Adults likely to receive, in 1 year, an intake in excess of the

applicable ALI(s).

Radionuclide Oral Ingestion ALI (µCi) Inhalation ALI (µCi) H-3 8,000 8,000 C-14 200 200 P-32 60 90 S-35 600 200 Cr-51 4,000 5,000 Co-57 800 300 Co-60 50 20 Ga-67 700 1,000 Rb-81 4,000 5,000 Sr-89 60 80 Tc-99m 8,000 20,000

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I-123 300 600 I-125 4 6 I-131 3 5 Cs-137 10 20 Tl-201 2,000 2,000

2) Minors and declared pregnant women likely to receive, in 1 year, a

committed effective dose equivalent in excess of 0.05 rem. 13.4 Proper Wearing of Personnel Monitoring Devices

Individuals who are issued personnel monitoring devices shall wear such devices as follows:

1) An individual monitoring device used for monitoring the dose to the

whole body shall be worn in an unshielded location of the whole body likely to receive the highest exposure. The whole body is defined as head, trunk (including male gonads), arms above the elbow, or legs above the knee.

2) An individual monitoring device used for monitoring the dose to an

embryo/fetus of a declared pregnant woman shall be located at the waist under any protective apron worn by the woman.

3) An individual monitoring device used for monitoring the eye dose

equivalent shall be located at the neck outside any protective apron worn by the individual, or at an unshielded location closer to the eye.

4) An individual monitoring device used for monitoring the dose to the

extremities shall be worn on the extremity likely to receive the highest exposure. The device shall be oriented to measure the highest dose to the extremity being monitored.

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14. Radiation Dose Limits 14.1 General Considerations

A New York Medical College employee is considered to have received an occupational dose of radiation if the dose was received in the course of employment in which the individuals assigned duties involved exposure to sources of radiation. An occupational dose does not include a dose received: from background radiation, as a patient from medical practices, from voluntary participation in medical research programs, or as a member of the general public.

14.2 Occupational Dose Limits (Annual)

Except for planned special exposures, no person shall transfer, receive, possess or use any radiation source so as to cause any individual adult to receive an occupational dose from all sources of radiation that exceeds any of the following limits:

Total effective dose equivalent limit

5 rem

The sum of the deep dose equivalent and the committed dose equivalent to any individual organ or tissue other than the lens of the eye

50 rem

A shallow dose equivalent to the skin or to any extremity. 50 rem

Dose equivalent to the lens of eye

15 rem

The occupational dose that any individual is allowed to receive in a calendar year

must be reduced by any occupational dose that the individual receives while in the employment of another institution during the same year.

Compliance with the dose limits shall be demonstrated by summing internal and

external doses. 14.3 Dose Limits for the Embryo and Fetus

The occupational exposure of pregnant or potentially pregnant women is an area of special concern. There are special limits for the embryo / fetus and those limits are listed below:

Total dose equivalent limit 0.5 rem Dose equivalent limit in a month 0.05 rem

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Although the mother can be considered as an occupationally exposed individual, the fetus cannot. Any exposure of the abdomen of a pregnant woman may also involve exposure of the fetus. The use of a surface dose as an estimate of the dose to the fetus fails to consider the attenuation of radiation in overlying tissue and amniotic fluid. Use of surface doses, therefore, will normally overestimate the fetal dose. Internal dose from certain ingested or inhaled radionuclides may represent a particular hazard if such materials can cross the placenta and be incorporated into fetal tissue. Employees shall be informed of the risks to which the fetus may be exposed and the methods available for reducing exposure. Individual counseling for these women is available. Included in any evaluation of risk and exposure will be existing personnel monitoring records, surveys of the workplace and a review of the sources of radiation. If this evaluation indicates the reasonable probability of a dose equivalent to the fetus in excess of 500 millirem during the gestation period, the employee should discuss her options with her supervisor. Once a pregnancy is made known to New York Medical College, exposure of the embryo / fetus should be no greater than 50 millirem in any one month.

14.4 Radiation Dose Limits for Individual Members of the Public

Public dose means the dose received by a member of the public from exposure to sources of radiation. It does not include occupational dose, dose received from background radiation, dose received as a patient from medical practices, or dose from voluntary participation in medical research programs.

Dose limits for individual members of the public are:

The dose in any unrestricted area from external sources 0.002 rem in any one hour Total effective dose 0.1 rem in a year

14.5 Occupational Dose Limits for Minors

No person shall transfer, receive, possess or use any radiation source so as to cause any individual minor to receive an occupational dose from all sources of radiation that exceeds any of the following limits:

Total effective dose equivalent limit

0.5 rem

The sum of the deep dose equivalent and the committed dose equivalent to any individual organ or tissue other than the lens of the eye

5 rem

A shallow dose equivalent to the skin or to any extremity. 5 rem

Dose equivalent to the lens of eye

1.5 rem

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15. Radioactive Material Spill Procedures 15.1 General Considerations

All spills of radioactive material must be cleaned up promptly. The responsibility for cleaning up and/or contacting the Radiation Safety Office rests on the individual user and his/her staff.

A major spill is defined as an uncontrolled and inadvertent release of radioactive material which exceeds 1.0 millicurie in activity. Under no circumstances should any untrained person attempt to examine or clean up a major spill of radioactive material. Fans or ventilating apparatus should not be turned on in an attempt to blow the isotope or its decay products away. Such a maneuver will only broadcast the radioactive materials throughout the area.

The Radiation Safety Officer shall be notified immediately of all accidents involving possible body contamination or ingestion of radioactivity by personnel; over-exposure to radiation; contamination of equipment; spread of contamination; and of difficulty in cleaning up a contaminated area. The Radiation Safety Office must be notified immediately in the event of loss of radioisotopes.

15.2 Minor Spills (< 1.0 millicuries)

The following procedures will be followed: 1) Notify all persons in the area that a spill has occurred.

2) Permit only the minimum number of persons in the area necessary to deal with the spill.

3) Prevent the spread of the contamination by covering the spill with absorbent pads.

4) Put on protective gloves.

5) If a liquid is spilled, place absorbent paper on the spill. 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.

6) If dry material, dampen thoroughly taking care not to spread the

contamination. Water may generally be used except where chemical reaction with the water would generate an air contaminant. In that situation oil should be used.

7) Notify the Radiation Safety Officer as soon as possible.

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8) Decontaminate the area using a monitor to check the progress of the clean-

up. 9) Monitor all persons involved in the spill and the clean up.

10) Permit no person to resume work in the area until a survey is made and approval of the Radiation Safety Officer is secured.

15.3 Major Spills ( > 1.0 milliCuries)

The following procedures will be followed: 1) Notify all persons not involved in the spill to vacate the room at once.

2) Attempt to right the overturned container with gloved hands. 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

accomplished without further contamination or a significant increase in radiation exposure.

4) Turn off all fans and ventilating devices.

5) Leave the room and lock or otherwise secure the area to prevent entry. Do not leave the vicinity until you are cleared by the Radiation Safety Officer.

6) Notify the Radiation Safety Officer immediately.

7) Take immediate steps to 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.

8) The Radiation Safety Officer will supervise the clean-up of the spill and

will complete the appropriate reports.

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16. Procedure for Calibrating Survey Instruments 16.1 General Considerations

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.")

16.2 Calibration Report

1. The report of a survey meter calibration should indicate the procedure used and the data obtained. The description of the calibration will include:

a. The owner or user of the equipment;

b. A description of the instrument that includes manufacturer, model number, serial number, and type of detector.

c. A description of the calibration source, including exposure rate at a

specified distance on a specified date, and the calibration procedure;

d. 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.

e. The reading indicated with the instrument in the "battery check"

mode (if available on the instrument);

f. The angle between the radiation flux field and the detector, for external cylindrical GM or ionization-type detectors, will usually be "parallel" or "perpendicular" indicating photons travelling either parallel or perpendicular to the central axis of the detector; for instruments with internal detectors, this should be the angle between flux field and a specified surface of the instrument.

g. For detectors with removable shielding, an indication of whether

the shielding was in place or removed during the calibration procedure;

h. The apparent exposure from the check source; and

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i. The name of the person who performed the calibration, the date on which the calibration was performed and the license number and issuing agency of any contractor who performed the calibration.

16.3 Survey Meter Calibration Sticker

The following information will be attached to the instrument as a calibration sticker or tag: 1) The source that was used to calibrate the instrument

2) The proper deflection in the battery mode (unless this is clearly indicated

on the instrument)

3) For each scale or decade, one of the following as appropriate:

a. The average correction factor; b. A graph or graphs from which the correction factor for each scale

or decade may be deduced;

c. An indication that the scale was checked for function but not calibrated or, an indication that the scale was inoperative;

d. The angle between the radiation flux and the detector during the

calibration;

e. The apparent exposure rate from the check source.

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17. Procedure for Leak-Testing Sealed Sources 17.1 General Considerations

Sealed radioactive sources must be checked for leakage when received and on a semi-annual basis thereafter. The source is wiped with a filter paper or other absorbent material, which is then counted for radioactivity. Often the swab is moistened with ethanol to improve the transfer of contaminant. Alpha and beta sources are particularly vulnerable to developing leaks in the coverings, which must be thin enough to allow penetration of the particles.

If there is reason to suspect that a sealed source might have been damaged, or might be leaking, then the source shall be tested for leakage before further use.

17.2 Exemption from Leak-testing Requirement

A sealed source is exempt from the leak test requirement when the source contains 100 microcuries or less of beta and/or gamma emitting material or 10 microcuries or less of alpha emitting material.

17.3 Procedure

1) Make a list of all sources to be tested. This should include the radionuclide, the activity on a specified date, and the physical form.

2) If the leak-test is to be performed on a source with an activity greater than

several millicuries, a survey meter should be at hand to monitor the 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. Do NOT wipe the port of beta applicators. Storage containers should also be wiped since contamination can accumulate there.

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.

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c. For teletherapy machines, take the wipe with the source in the off position. Wipe the area near the shutter mechanism, but be careful not to touch either the field light and mirror or crosshairs. Also wipe the primary and secondary collimators and trimmers.

d. If you are testing radium sources, they should be checked for radon

leakage. This can be accomplished by submerging the source in a vial of fine-grained charcoal or cotton for 24 hours. Then remove the source and analyze the adsorbent sample. A survey should be done to be sure the sources are adequately shielded during the leak-test period.

e. If you are testing iodine sources, they should be checked for vapor

leakage. This can be done by submerging the source in charcoal or vermiculite for 24 hours, removing the source and analyzing the adsorbent sample.

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 scale or a GM survey meter may be appropriate. Dose calibrators 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 radionuclide 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 radionuclide 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 analysis procedure for all wipe samples.

f. If the wipe sample activity is greater than or equal to 0.005 microcurie, notify the Radiation Safety Officer. The source must be withdrawn from use to be repaired or discarded. If it is a

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radionuclide licensed under the New York State Department of Health, the Department of Health must be notified.

g. Sign and date the list of sources, data and calculations.

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18. Procedure for Radioactive Waste Disposal 18.1 Introduction

There are five commonly used methods of radioactive waste disposal:

a. discharge of radioactive material into the atmosphere;

b. release to the environment through the sanitary sewer or by evaporative release;

c. decay-in-storage (DIS); d. transfer to a burial site or back to a manufacturer; e. release to in-house waste. 18.2 General Guidance

a. All radioactivity labels must be defaced or removed from containers and packages prior to disposal in in-house waste. In the situation where the waste is compacted, all labels that are visible in the compacted mass must be defaced or removed.

b. Non-radioactive waste such as leftover reagents, boxes and packing

material should not be mixed with radioactive waste.

c. Occasionally monitor all procedures to ensure that radioactive waste is not created unnecessarily. Review all procedures to ensure that waste is handled in a manner consistent with established procedures.

d. In all cases, consider the entire impact of various available disposal routes.

Consider occupational and public exposure to radiation, other hazards associated with material and routes of disposal (e.g., toxicity, carcinogenecity, pathogenecity, flammability), and expense.

18.3 Discharge of radioactive material to the atmosphere The annual average concentration of radionuclides in the effluent at the point of discharge must be less than the radionuclide concentrations listed in Table 1.

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18.4 Release of radioactive material to the sanitary sewer

Liquids may be disposed of by release to the sanitary sewer or evaporative release to the atmosphere. This does not relieve New York Medical College from complying with other regulations regarding toxic or hazardous properties of these materials.

Permission to dispose of radioactive waste through the sanitary sewer must be obtained from the Radiation Safety Officer prior to disposal. Permission to release radioactive material into the sanitary sewer may be granted ONLY if each of the following conditions is met:

a. The material is readily soluble or dispersible in water or it is biological

material that is readily dispersible in water.

b. The quantity of radioactive material released into the sewer in 1 month divided by the average monthly volume of water released into the sewer does not exceed the concentration listed in Table 2.

c. If more than one radionuclide is released, the following conditions must

also be satisfied:

i. the fraction of the limit in Table 2 must be determined by dividing the actual monthly average concentration of each radionuclide released into the sewer by the concentration of that radionuclide listed in Table 2, and

ii. The sum of all the fractions must not exceed 1.00.

d. The total quantity of radioactive material released into the sanitary sewer in a year shall not exceed 5 curies of hydrogen-3, 1 curie of carbon-14 and 1 curie of all other radioactive materials combined.

e. A sink must be designated and labeled as the radioactive disposal sink and

it must be the only one used for this purpose.

f. An appropriate amount of water (as determined by the Radiation Safety Officer) must be flushed down the sink at the time of disposal. A long neck funnel must be inserted in the drain to ensure that the radionuclide is delivered into the sewer system in such a manner as to not allow removable surface contamination in the sink. A wipe test of the area shall be performed to confirm the absence of removable contamination.

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18.5 Decay-In-Storage (DIS) Short-lived radioactive material (physical half-life less than 90 days) may be disposed of by DIS. Radioactive material disposed of in this fashion should be separated according to half-life. The Radiation Safety Office will provide 5 gallon yellow pails for the temporary storage of DIS waste in the laboratory. When the pail is full or when additional waste generation is not anticipated, the Radiation Safety Office shall be called to arrange removal of the pail. DIS waste may not have any other hazardous qualities – i.e. flammable liquid. The following rules apply to DIS waste.

a. Sharps and medical waste must be stored separately from other waste.

b. Separate containers shall be used for each isotope.

c. No shielding is to be placed within the container. If shielding is required

it must be employed outside the container and it must be removed before the final survey.

d. All radioactivity labels must be removed or defaced before items are placedwithin the container. An appropriate radioactivity label must be placed on the exterior of the container.

e. Contact the Radiation Safety Office when the 5 gallon yellow containers

are full. Radiation Safety will pick them up and exchange them for empty containers.

The radiation safety office will store DIS in the following manner:

f. When a DIS large container is full, seal it with tape and attach an

identification tag to the outside of the container. The identification tag should include the following information:

i. container identification number ii. date the container was sealed iii. radionuclides present in the container iv. projected date of removal from storage

g. A written log will be kept. This log will contain the following information:

i. container identification number ii. date the container was sealed iii. radionuclide and activity present in the container

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iv. initial exposure level at the surface of the container v. initials of the person placing the container into storage h. Decay the material for at least 10 half-lives.

i. While in storage the container integrity will be checked monthly. Wipe tests will also be performed weekly. Ambient radiation levels will also be measured on a weekly schedule.

j. Prior to disposal as in-house waste, monitor each container as follows: i. Check the radiation detection survey meter for proper operation; ii. Monitor the container in a low radiation area (< 0.05 mR/hr); iii. Remove any shielding from around the container; iv. Monitor all surfaces of the container;

v. 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 the final radiation level for each container. Check to make sure that no radiation labels are visible;

vi. Containers that exceed background radiation levels must be returned to the storage area for further decay.

k. 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 at the work area. Dismantle the oldest generator first, then work forward chronologically. Hold each individual column up to the radiation detection survey meter in a low background (< 0.05 mR/hr) area. Log the generator date and disposal date for the waste disposal records. Remove or deface the radiation labels on the generator shield.

18.6 Long Lived Radioactive Waste

Long-lived radioactive material (physical half-life equal to or greater than 90 days) may be disposed of by transfer to burial. Radioactive material disposed of in this fashion need not be separated according to half-life. The Radiation Safety Office will provide 5 gallon yellow pails for the temporary storage of long-lived waste in the laboratory. When the pail is full or when additional waste generation is not anticipated, the Radiation Safety Office shall be called to arrange removal of the pail. Long-lived waste may not have any other hazardous qualities – i.e. flammable liquid.

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18.7 Return radioactive material to manufacturer

Whenever possible, it is desirable to return radioactive material to the manufacturer. When radioactive material is returned to the manufacturer, the following information is required:

a. Retain records required to demonstrate that the package qualifies under appropriate Department of Transportation rules. b. Assemble the package in accordance with the manufacturers instructions. c. Perform required dose rate and removable contamination measurements.

d. Label the package and complete the shipping papers in accordance with the manufacturers instructions.

18.8 Disposal of exempt waste

The following radioactive material may be disposed of without regard to its radioactivity, but must be disposed of in accordance with any other applicable provisions of environmental conservation laws: a. 0.05 microcuries, or less, of hydrogen-3 or carbon-14 per gram of medium

used for liquid scintillation counting, and

b. 0.05 microcuries, or less, of hydrogen-3 or carbon-14 per gram of animal tissue, averaged over the weight of the entire animal. Tissue disposed of in this manner may not be used as food for humans or animal feed.

The Radiation Safety Officer must approve the above cited waste as exempt from radioactive waste regulations prior to its disposal.

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19. Radiation Surveys 19.1 General Requirements

It is the authorized users responsibility to provide for appropriate surveys of work areas when using radioactive materials. Recommendations for special survey techniques may be made by the Radiation Safety Committee upon issuance of the authorization to use radioactive materials.

19.2 Removable Contamination Surveys The following rules apply to surveys for removable contamination (wipe tests):

i. In laboratory areas where quantities of radioactive material greater than 200 microcuries are possessed, a weekly survey for removable contamination (wipe test) must be performed by the principal investigator or their appointee.

ii. In laboratory areas where small quantities of radioactive materials are

possessed (< 200 microcuries), a monthly survey for removable contamination must be performed by the principal investigator.

iii. In radioactive material storage and radioactive waste storage areas, a

weekly survey for removable contamination must be performed.

iv. The wipe test assay procedure should be sufficiently sensitive to detect the presence of 200 dpm/100 cm2 of removable contamination. You must use a radioactive source with a known amount of activity to convert sample measurements to dpm.

v. Immediately notify the Radiation Safety Office if you find unexpectedly

high levels. 19.3 Ambient Exposure Rate Surveys

The following rules apply to ambient exposure rate survey (Geiger counter surveys):

i. In laboratory areas where quantities of radioactive materials (other than tritium) greater than 200 microcuries are possessed, a weekly survey with a low-range survey meter must be performed by the principal investigator.

ii. In laboratory areas where small quantities of radio-active materials are possessed (<200 microcuries), a monthly survey with a low range survey meter must be performed by the principal investigator.

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iii. In radioactive material storage and radioactive waste storage areas, a

survey must be performed weekly with a low-range survey meter.

iv. Immediately notify the Radiation Safety Office if you find unexpectedly high or low levels.

19.4 Survey Records

A record must be kept of the exposure rate and contamination survey results. For wipe tests this means filling out the Wipe Test Worksheet (Appendix 3). For ambient surveys the appropriate document is the Ambient Survey Worksheet (Appendix 4). The records must include the following information:

• the date, area surveyed, and equipment used.

• the name of the person who made the survey.

• a drawing of the areas surveyed and contamination and exposure rate action

levels as established by the Radiation Safety Officer. • measured exposure rates in mR/hour or contamination levels in dpm/100 cm2,

as appropriate. • Actions taken in the case of excessive exposure rates or contamination and • follow-up survey information.

The Radiation Safety Office will review the record on a quarterly basis. The Radiation Safety Officer will be notified promptly in those cases in which action levels were exceeded.

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20. Requirements for Radioactive Material Use Areas 20.1 General Considerations

Laboratory facilities for handling unsealed radioactive materials must provide adequate containment and allow for ease of cleanup in the events of contamination incidents. Glassware, tongs, and other equipment used to handle unsealed radioactive material should be segregated and given a distinct marking to prevent use with nonradioactive materials.

20.2 Hoods

Hoods are necessary for controlling possible airborne contamination arising from work with unsealed radioactive materials. Any laboratory utilizing millicurie amounts of radioisotopes of iodine (I-125 and I-131) must use a functioning hood. The airflow into the hood must be adequate, and the hood must be designed so the flowlines are all directed into the hood. Airflow into the hood should be at least 100 linear feet per minute when the hood sash is open to 15 inches. The hood should have its own exhaust system and not be connected into other hoods, as this could be a mechanism for the transmission of airborne radioactivity to other laboratories through improper baffling. The exhaust system should have provisions for installing filters, if needed. The working surface should be able to support lead shielding. Controls for air, water, etc., should be located outside the hood. Even when hoods are used it is often worthwhile to collect and filter particulate radioactive emissions from the operation with local suction devices located near the source, since this can help minimize contamination of the hood and diminish the work required later for decontamination. Even the best hoods do not completely isolate the area inside the hood from the laboratory. Laboratories may need to use a complete isolating system such as a glove box if activities in excess of 100 millicuries are to be processed. Complex wet operations of dry and dusty procedures may also require the use of a glove box.

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20.3 Classification of Areas

New York Medical College may restrict access to areas for the purpose of protecting individuals from exposure to radiation and radioactive material. The following is a general description of Controlled and Non-Controlled Areas:

a. Non-controlled Areas

An area is designated as non-controlled when it meets the following criteria:

i an individual who is continually present in the area, cannot receive

more than two mrem in any one hour or 100 mrem in any seven consecutive days to any portion of the body; and

ii. if, when allowance is made for expected occupancy and time

variations in dose-rate, no individual is likely to receive more than 100 mrem in a calendar year.

b Controlled Areas

All areas within New York Medical College which dose levels do not conform to the standard for non controlled areas shall be controlled and under the control of the Radiation Safety Officer for radiation safety purposes. A sign carrying the words, "Caution Radioactive Materials" and, if appropriate, "Caution Radiation Area" shall be prominently displayed at the entrance to each controlled area, and the permit holder responsible for work with radioisotopes in that area shall be responsible for controlling access to the area.

20.4 Posting of Areas and Other Required Labels

Signs are required to denote areas of containers with levels of radiation or radioactivity specified in the following sections. Signs may be ordered through the Radiation Safety Officer.

The following signs are to be employed at New York Medical College: a. "Caution Radiation Area"

This label is to be used in areas accessible to personnel in which radiation levels could result in an individual receiving a dose equivalent in excess of 5 mrem in one hour at 30 centimeters from the source of radiation or from any surface that the radiation penetrates.

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b. "Caution Radioactive Material"

This label is to be used in areas in which radioactive material is used or stored in amounts exceeding ten times those listed in Appendix 1. It is also to be used on containers in which radioactive material is transported, stored or used in amounts exceeding those in Appendix 1

When containers are used for storage, the labels shall state the quantities and kinds of radioactive materials and the date of measurement.

A label is NOT required if the concentration of the material in the container does not exceed the maximum permissible concentration for occupationally-exposed individuals listed in Table 4, Schedule I, Column 2 of the New York State Sanitary Code - Part 16 (Appendix 11).

c. "High Radiation Area"

This label is to be used in areas accessible to individuals, in which radiation levels could result in an individual receiving a dose equivalent in excess of 100 millirem in one hour at 30 centimeters from any source of radiation or from a surface that the radiation penetrates.

d. "Airborne Radioactivity"

This label is to be used in areas accessible to individuals, in which airborne radioactive materials exist in concentrations to such a degree that an individual present in the area without respiratory protective equipment could exceed, during the hours an individual is present in a week, an intake of 0.6 percent of the annual limit on intake (ALI) or 12 DAC-hours. The Radiation Safety Officer must be consulted regarding control measures and labeling needs in this area.

20.5 Storage of Radioactive Materials

The following rules shall be followed in the storage of radioactive materials:

a. Radioisotopes requiring a "Radioactive Materials" label must be stored in areas under the control of the user, which must be locked or otherwise secured against unauthorized removal of the material.

b. The radioisotopes shall be stored in a container, shielded if necessary,

such that the radiation at a distance of one foot from the container does not exceed 100 mrem/hour, i.e. the area may be classified as no more than a Radiation Area.

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c. Containers must be properly labeled and area signs posted where necessary.

d. Suitable precautions shall be taken so that the probability of an explosion

in the storage area which would cause the dispersion of the radioactivity is very small.

20.6 Design of New Facilities

The design of all facilities involving the use, handling or storage of radioactive materials shall be reviewed by the Radiation Safety Officer to assure the maintenance of adequate environmental protection.

20.7 Vacating Facilities

The Radiation Safety Officer should be informed by an authorized user whenever a facility used for radioisotope work or storage is to be vacated so that appropriate measures, e.g. a final contamination survey, may be taken before the facility is released to a new occupant.

20.8 Contamination Levels

Radioactive contamination levels of air and water in controlled areas must be controlled such that the levels in µCi/ml specified in Appendix 16-A, Table 4, Schedule I, of the New York State Sanitary Code are not exceeded (See Appendix 11 in the back of this manual). In non-controlled areas, contamination levels of air and water shall not exceed those specified in Appendix 16-A, Table 4, Schedule II, of the New York State Sanitary Code (See Appendix 11). Removable surface contamination levels for beta or for beta-gamma emitters shall be controlled such that a radiation level of 1000 dpm per 100 cm2 is not exceeded. Fixed surface contamination with beta or beta-gamma emitters shall be controlled such that a radiation level of 0.1 mrad/hr. (measured close to the surface with a suitable detector) is not exceeded.

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Appendix 1

Monitoring Device Request Form To request a radiation monitoring device, please fill in the form below. Please type or print neatly. All information submitted on this form will be treated as confidential. The information below will be forwarded to the company providing the radiation monitoring devices. There will be no other disclosure of information contained in this form without the written consent of the individual. Your First Name Your Last Name Title Social Security Number - - Date of Birth (Month/Day/Year) / / Sex Male Female Building Department Principal Investigator Laboratory Room Number Laboratory Telephone Number Previously Badged at Another Institution? Yes No Name of Previous Institution Previously Badged at New York Medical College? Yes No Name of Previous Department Will You Be Handling Radioactive Material? Yes No

Signature:_______________________________________________________________ Date:___________________________________________________________________ Notes:__________________________________________________________________

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Appendix 2

Radioactive Material Utilization Log The log below must be maintained for every shipment of radioactive material received by the laboratory. Every shipment must be entered on a separate sheet. 1. Shipment Information

Date Received P.O. Number Vendor Catalog Number Radionuclide Initial Activity (microcuries) Number of Containers

2. Utilization Log

Enter the date received and the initial activity (microcuries) in the first row. As activity is removed, balance the log accordingly using the succeeding rows. When the activity in the vial is completely utilized the activity remaining should equal 0 and the sum of the sanitary sewer, radioactive waste drums, and storage columns should equal the initial activity received.

Date Activity

Removed Activity Remaining

Sanitary Sewer

Radioactive Waste Drum

Storage

xxxxxxxxxx xxxxxxxxxx xxxxxxxxxx xxxxxxxxxx 0

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Appendix 3

Wipe Test Worksheet

1. General Information Possession Greater Than 200 uCi – Wipe Test Weekly Possession Less Than 200 uCi – Wipe Test Monthly

Date Department Room Number Counting Equipment Model Number Surveyor

2. Wipe Survey Data ( Attach Map Sketch)

Location Date Date Date Date Date

dpm dpm dpm dpm dpm

dpm dpm dpm dpm dpm

dpm dpm dpm dpm dpm

dpm dpm dpm dpm dpm

dpm dpm dpm dpm dpm

dpm dpm dpm dpm dpm

dpm dpm dpm dpm dpm

dpm dpm dpm dpm dpm

dpm dpm dpm dpm dpm

dpm dpm dpm dpm dpm

3. Results

All results must be less than 1000 dpm per 100 cm2. Any areas with removable contamination in excess of 1000 dpm must be decontaminated and resurveyed until wipe tests are below 1000 dpm. Comments:________________________________________________________ Signature of Surveyor:_______________________________________________

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Appendix 4

Ambient Survey Worksheet 1. General Information

Date of Survey Department Room Number Survey Equipment Model Number Surveyor

2. Survey Data

Location Date Date Date Date Date

mR/hour mR/hour mR/hour mR/hour mR/hour










3. Results

For Non-controlled area, all results must be less than 0.1 mR/hour. Any non-controlled areas with ambient radiation levels in excess of 0.1 mR/hour must be decontaminated and resurveyed until ambient levels are below 0.1 mR/hour. Comments:________________________________________________________ Signature of Surveyor:_______________________________________________

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Appendix 5

New York Medical College Application For Permit To Use Radioactive Material

1. General Information

Date

Applicant

Department

Is this a New Permit? Yes No

Others Working on Project

____________________________________________ ____________________________________________

Are these persons under your direct supervision?

Yes No

2. Radioactive Compounds Requested

Radionuclide Chemical Form

Physical Form

Range of Activity in Normal Use

How often to be supplied

Maximum Possession Limit

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3. Location where radioactive material will be delivered, processed, and stored. Department

Building

Floor

Room Number

Please attach a diagram for all areas where radioactive materials will be used. Diagrams should include dimensions and be drawn to scale. Relevant objects and equipment should be shown (i.e. sinks, fume hoods, storage units). Identify adjacent areas across the walls from use and storage locations.

4. Details of Project

Please describe the details of work. This should include radionuclide procedures and techniques.

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5. Training and Experience of Applicant

Type of Training

Location of Training

Duration Practical Training

Formal Course Work

Radiation Protection

Yes No Yes No

Radiation Instrumentation

Yes No Yes No

Radiation Protection

Yes No Yes No

Radiation Biology

Yes No Yes No

Radiation Chemistry

Yes No Yes No

Mathematics pertaining to radioactive materials

Yes No Yes No

6. Experience with Radionuclides

Radionuclide Activity Institution where experience was gained

Duration Type of Use

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7. Equipment of Applicant

The following equipment will be used for storage and handling of radioactive material:

Safety Equipment Yes No

Disposable Gloves Lab Coats Protective Eyewear Respirators Mobile Shields Shielded Containers

Radiation Monitoring Equipment

Type

Manufacturer Model Location

Geiger Counter

Liquid Scintillation Counter

Crystal Scintillation Counter

Dose Calibrator

Ionization Chamber

Other

8. Provisions for Monitoring and Health Protection

Procedure Frequency

Whole Body Dosimeter Ring Dosimeter Thyroid Uptake Urinalysis Wipe Tests Geiger Surveys Air Monitoring

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9. Animal Use Applications

What type of animal is to be employed?

What is the average mass of the animal?

What radionuclide will be employed?

What activity of radionuclide will be administered to each animal?

What is the concentration of radionuclide activity / mass?

Where will animal experiment be conducted?

Where will the animal be housed?

How will the carcass be disposed?

10. Human Use Applications

Is applicant a physician licensed to dispense drugs in the practice of medicine in the State of New York?

Yes No

Has applicant ever been authorized for human use of radionulcides on a radioactive material license?

Yes No

What radionuclide will be administered?

What activity of radionuclide will be administered?

What is the route of administration?

Is this a diagnostic procedure?

Yes No

Is this a therapeutic procedure?

Yes No

What is the name of the vendor supplying the radioactive material?

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Applications for human use authorization must be approved by the New York State Department of Health. The application process can take several months to complete.

11. Signature

Signature of Applicant

Date

12. Approvals

Chair – Radiation Safety Committee

C. Andrew Powers, Ph.D Radiation Safety Officer

Matty H. Mozzor, RRPT Departmental Chairperson

Administration

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Appendix 6

Report of Past Exposure Form

New York Medical College Radiation Safety Office

Valhalla, New York 10595 (914) 594-4078

Previous Institution and Address

To Whom it May Concern: In accordance with the New York State Sanitary Code, Chapter 1, Part 16, Section 16.6, New York Medical College is requesting from your institution a copy of the radiation exposure history for the following individual: Name

Social Security Number

Period of Employment

Thank you for your cooperation in this matter. Respectfully, Matty H. Mozzor Radiation Safety Officer I hereby authorize ________________________________________________ to provide the New York Medical College with a record of my exposure history. _________________________________ _____________________ Signature Date

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Appendix 7

Radioactive Package Receipt and Monitor Log

Date Purchase

Order

Radio-nuclide

Activity (µCi)

Vendor Catalog Number

Package Damage

?

mR/hour

Initials

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Appendix 7a

Radioactive Package Receipt and Monitor Log for Undeliverable Packages

Fill in log for all radioactive material packages that must be temporarily stored in the Shipping and Receiving Freezer. Contact the RSO ( ext 4448) for radionuclide and activity information. All packages temporarily stored in the Shipping and Receiving freezer are considered to be transferred to the RSO upon contact with the RSO.

Date Store

d

Purchase

Order

Radio-nuclide

Activity (µCi)

Vendor Inves-tigator

Package OK?

RSO Contacted

?

Date Delivere

d

Initials

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Appendix 8

Report of Thyroid Bioassay 1. General Information

Date Department Counting Equipment Counting Time Standard Radionuclide Standard Activity Standard CPM Background CPM Efficiency

2. Thyroid Uptake Data

Name Thyroid CPM BKG CPM Net CPM Net µCi

3. Results No evidence of deposition of radio-iodine in the thyroid gland. Respectfully, Matty H. Mozzor Radiation Safety Officer

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Appendix 10 Notice to Employees

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Appendix 11

New York Medical College Radiation Safety Office

Room 230 Vosburgh Pavilion

Declaration of Pregnancy Form Last Name:___________________________________________________________________ First Name:___________________________________________________________________ Department: __________________________________________________________________ Location:_____________________________________________________________________ Telephone #: _________________________________________________________________ Date of Conception:____________________________________ Description of Duties:__________________________________________________________ __________________________________________________________ __________________________________________________________ __________________________________________________________ ________________________ ________________________ Matty H. Mozzor Radiation Safety Officer Signature ________________________ Date All information on this form will be kept confidential and used ONLY by the Radiation Safety Department for the purposes of regulatory compliance.

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Appendix 12

Radiation Safety Audit Form

Date: _____________ Licensee: New York Medical College Location: _____________ Principal Investigator: _____________ Auditor: _____________ What radionuclides are used? H-3 C-14 Na-22

P-32 P-33 S-35 Ca-45 Cr-51 Co-57

Co-60 Sr-89 Sr-90 Tc-99m In-111 In-113m I-123 I-125 I-131 Cs-137 Tl-201

Radioactive material license in order? Yes No N/A Radioactive Permit in order? Yes No N/A Quarterly Radiation Safety Committee Meetings? Yes No N/A Workers wearing disposable gloves? Yes No N/A Workers wearing lab coats? Yes No N/A Work areas covered with absorbant pads? Yes No N/A Food, drink, applying cosmetics or smoking in lab? Yes No N/A Weekly wipe tests performed? Yes No N/A Weekly surveys performed? Yes No N/A Survey meter calibrated annually? Yes No N/A Radioactive Material User Log? Yes No N/A Sealed source inventory Yes No N/A Sealed source wipe test results? Yes No N/A Radiation Safety Manual? Yes No N/A Notice to Employees? Yes No N/A Emergency procedures? Yes No N/A Appropriate radiation signs? Yes No N/A Labeled radioactive material containers? Yes No N/A Whole body dosimeters? Yes No N/A Ring dosimeters? Yes No N/A Environmental Dosimeters Yes No N/A Bioassays? Yes No N/A Monthly review of exposure records? Yes No N/A Exposures in excess of 125 mrem/quarter? Yes No N/A Radioactive waste disposal? DIS NDL Sanitary Sewer Animal Carcass Staff orientation/refresher training? Yes No N/A

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Ambient Radiation Levels _________ mR/hr Removable Contamination Survey _________ dpm/100 cm2 Persons present during audit_______________________________________________________ Conclusions:___________________________________________________________________

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TABLE 1

Effluent Concentrations in Air

Radionulcide Effluent Concentration in Air (µCi/ml)

Hydrogen-3 1 x 10-7 Iodine-125 3 x 10-10 Iodine-131 2 x 10-10 Xenon-133 5 x 10-7

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TABLE 2

Concentrations of Radionuclides in the Sanitary Sewer

Radionulcide Concentration in Sanitary Sewer

(µCi/ml) Hydrogen-3 1 x 10-2 Carbon-14 2 x 10-4 Sodium-22 6 x 10-5 Phosphorus-32 9 x 10-5 Sulfur-35 1 x 10-3 Scandium-46 5 x 10-4 Chromium-51 5 x 10-3 Cobalt-57 6 x 10-4 Cobalt-60 3 x 10-5 Zinc-65 5 x 10-5 Gallium-67 1 x 10-3 Selenium-75 7 x 10-5 Rubidium-86 7 x 10-5 Strontium-85 4 x 10-4 Strontium-89 8 x 10-5 Niobium-95 3 x 10-4 Molybdenum-99 2 x 10-4 Technetium-99m 1 x 10-2 Technetium-99 6 x 10-4 Indium-111 6 x 10-4 Indium-113m 7 x 10-3 Iodine-125 2 x 10-5 Iodine-131 1 x 10-5 Cerium-141 3 x 10-4 Rhenium-186 3 x 10-4 Rhenium-188 2 x 10-5 Tungsten-188 7 x 10-5 Thallium-201 2 x 10-3

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TABLE 3

MAXIMUM ALLOWABLE MONTHLY ACTIVITY IN THE SANITARY SEWER

Radionulcide Maximum Activity per

Month (mCi)

Μ Annual Activity (Ci)

Hydrogen-3 416 0.0104 5.000 Carbon-14 10 0.0082 0.120 Sodium-22 * Phosphorus-32 20 0.0544 0.240 Sulfur-35 10 0.0024 0.120 Scandium-46 * Chromium-51 10 0.0004 0.120 Cobalt-57 * Cobalt-60 * Zinc-65 * Gallium-67 * Selenium-75 * Strontium-85 * Strontium-89 * Niobium-95 * Molybdenum-99 * Technetium-99m * Technetium-99 * Indium-111 * Indium-113 * Iodine-125 30 0.367 0.360 Iodine-131 * Cerium-141 * Rhenium-186 * Rhenium-188 * Tungsten-188 * Thallium-201 *

Totals 0.4348 0.840 ** * These radionuclides are rarely disposed of through the sanitary sewer. If the situation

arises where this radionuclide is to be disposed of through the sanitary sewer, the Radiation Safety Officer shall make a special calculation to determine the appropriate limit.

** Total does not include Hydrogen-3 and Carbon-14

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TABLE 4

Quantities of Radioactive Materials Requiring Labeling

Radionulcide Quantity (µCi)

Hydrogen-3 1000 Carbon-14 1000 Sodium-22 10 Phosphorus-32 10 Sulfur-35 100 Scandium-46 10 Chromium-51 1000 Cobalt-57 100 Cobalt-60 1 Zinc-65 10 Gallium-67 1000 Selenium-75 100 Rubidium-86 100 Strontium-85 100 Strontium-89 10 Niobium-95 100 Molybdenum-99 100 Technetium-99m 1000 Technetium-99 100 Indium-111 100 Indium-113m 1000 Iodine-125 1 Iodine-131 1 Cerium-141 100 Rhenium-186 100 Rhenium-188 100 Tungsten-188 10 Thallium-201 1000

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