TULANE UNIVERSITY MEDICAL CENTER

1430 TULANE AVENUE

NEW ORLEANS, LA 70112

REVIEWED AND APPROVED
09 SEPTEMBER 1997
LOUISIANA LICENSE NO.: LA-0004-L01
Chairman, Radiation Safety Committee
Radiation Safety Officer

TABLE OF CONTENTS

I. Objectives of Radiation Protection

III. Radiation Safety Officer

IV. Guidelines for Nuclear Medicine Activities Involving Technicians & Other Paramedical Personnel

V. Routine for Ordering, Receiving,Opening Packages Containing Radioactive Material; Procedure for Documenting Use of Material.

VI. Instructions for Administration of Radiopharmaceuticals for Diagnostic and Therapeutic Procedures

VII. Laboratory Rules for Use of Radioactive Material

VIII. Restriction and Labeling of Radiation Areas

IX. Personnel Monitoring Policy

XI. Radiation and Contamination Area Surveys

XII. Decontamination Procedures

XIII. Contaminated Equipment

XIV. Emergency Procedures

XVI. Instructions for Housekeeping

XVII. Escort Personnel

XVIII. Instructions for Visitors

XIX. Storage of Radionuclides

XXII. Safety Rules: Fixed Fluoroscopic

XXIII. Safety Rules: Operators of Mobile Radiographic Equipment

XXIV. Safety Rules: Operators of Mobile Fluoroscopic Equipment

XXV. Safety Rules: Persons in the Vicinity of Mobile X-Ray Equipment

XXVI. Specific Instructions for Allied Medical Workers

XXVII. Radiation and Pregnancy, Radiation and Allied Medical Staff

XXVIII. Diagnostic Radiology and the Pregnant Patient

XXIX. Patient Pregnancy Screening

XXX. Nuclear Medicine and the Pregnant Patient

XXXI. Quality Control Procedures

XXXIV. Procedure for Monitoring and/or Checking Trap Effluent

APPENDIX

APPENDIX A. Radiation Safety Committee

APPENDIX B. Technologists Approved For Radionuclide Injection

APPENDIX C. Daily Incoming/Outgoing Shipment Inspection Log

APPENDIX D. Radionuclide Distribution

APPENDIX E. Dose Calibrator Calibration Record

APPENDIX F. Radionuclide Decay-In-Storage/Disposal Form

APPENDIX G. Instrument Maintenance and Repair Record

APPENDIX H. Radiation History Request Form

APPENDIX I. Film Badge Monitoring Service Request

APPENDIX J. Notice to Employees

APPENDIX K. Effective Dose Equivalent Limit Recommendations

APPENDIX L. Model Program for Maintaining Occupational Radiation Exposure at Medical Institutions ALARA

APPENDIX M. Standards for Protection Against Radiation

APPENDIX N. Diagnostic And/Or Therapeutic Procedure Misadministration Report

APPENDIX O. Therapeutic Radionuclide Consultation Form

APPENDIX P. Quality Management Program

APPENDIX Q. Quality Management Program

APPENDIX R. Quality Management Checklist for Administration of ¹²⁵I, ¹³¹I Activities Greater than 30mCi

APPENDIX S. Instructions for Brachytherapy

APPENDIX T. Operating Room Care: Brachytherapy Sources

APPENDIX U. Nursing Care, Brachytherapy Sources/Radiopharmaceutical Therapy

APPENDIX V. Radionuclide Therapy Survey

APPENDIX W. Activities and Dose Rates For Authorizing Patient Release

APPENDIX X. Activities and Dose Rates Above Which Instructions Should
Be Given When Authorizing Patient Release

APPENDIX Y. Activities of Radiopharmaceuticals That Require Instructions And
Records When Administered To Patients Who Are Breast-Feeding An Infant or Child

APPENDIX Z. Home Instruction: Radiopharmaceutical Therapy

APPENDIX AA. Home Instructions

APPENDIX BB. ⁹⁰Sr Opthalmic Applicator Therapy

APPENDIX CC. Instructions For Family of Released Patient

APPENDIX DD. Report of Radioactivity of Cadaver

APPENDIX EE. Instructions To Funeral Director For Embalming Body Containing Radioactive Material

APPENDIX FF. Autopsy Or Surgery Precautions

APPENDIX GG. Mammography Requirements

APPENDIX HH. Authorization Use of Radioactive Materials

APPENDIX II. Authorization to Use Radionuclides: Research Facilities/Laboratories

APPENDIX JJ. SI Units For Radiation Protection

APPENDIX KK. Units And Definitions

APPENDIX LL. Management Of Victims Of Radioactive Contamination

APPENDIX MM. Condensed Research Laboratory Rules
 

A. General
 

The specific objectives of radiation protection are: (1) to prevent, to the extent practicable, the occurrence of severe radiation-induced nonstochastic diseases by adhering to dose equivalent limits that are below the apparent practical threshold dose equivalent levels; and (2) to limit risk of the stochastic effects, fatal cancer and genetic effects, to a reasonable level in comparison with non-radiation risks and in relation to societal needs, benefits gained and economic factors. These objectives are achieved by applying individual dose equivalent limits for occupational and nonoccupational (general public) exposures.
 

It is emphasized that for the purposes of radiation protection, a cautious assumption is made, the reliability of which has not been established. This is the assumption that the dose-risk relationship is strictly proportional (linear) without threshold throughout the range of radiation protection. Furthermore, doses and the probability of response (risk) are assumed to accumulate linearly. At higher doses, received acutely, such as in accidents, more complex (non-linear) dose-risk relationships may apply.
 

Under these assumptions, any selected dose equivalent limit will have an associated level of risk. Tulane University Medical Center endorses the following: (1) the need to justify any activity which involves radiation exposure on the basis that the expected benefits exceed the predicted cost (justification); (2) the need to reduce the total radiation detriment from such justifiable activities or practices to AS LOW AS IS REASONABLY ACHIEVABLE (ALARA), economic and social factors being taken into account and (3) the need to apply individual effective dose equivalent limits to ensure that the procedures for justification and ALARA do not result in individuals or groups of individuals exceeding levels of acceptable risk.
 

B. ALARA
 

Tulane University Medical Center is committed to keeping exposures ALARA. The Radiation Safety Committee (RSC) will perform an annual review of the radiation safety program. This shall include review of summaries of the types and amounts of radioactive material used, occupational dose reports, and continuing education and training for all personnel who work with or in the vicinity of radioactive material. The purpose of the review is to ensure that individuals make every reasonable effort to maintain occupational doses, doses to the general public and releases of radioactive material ALARA, taking into account the state of technology and the cost of improvements in relation to benefits. Modification to operating procedures or to equipment and facilities will be made where they will reduce exposures unless the cost is considered to be unjustified. In addition to maintaining doses to individuals as far below the limits as is reasonably achievable, the sum of the doses received by all exposed individuals will also be maintained at the lowest practicable level.
 

The RSC will delegate authority to the Radiation Safety Officer (RSO) for enforcement of the ALARA concept.
 

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

ALARA LEVELS

Investigational Levels (mrems per calendar quarter)
 

Level I Level II
 

Whole body; head and trunk; 125 375

active blood-forming organs;

lens of eye; gonads
 

Hands and forarms; feet and 375 1125

ankles
 

Skin of whole body* 1250 3750
 

*Not normally applicable to nuclear medicine operations except those

using significant quantities of beta emitting nuclides.
 
 
 
 

The following actions will be taken at the Investigational Levels stated in the ALARA LEVELS Table above.
 

1. QUARTERLY EXPOSURE OF INDIVIDUALS TO LESS THAN INVESTIGATIONAL LEVEL I.
 

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

2. PERSONNEL EXPOSURE 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. He will report the results of his review 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 RSC. The RSC 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 RSC minutes. No written notification of the exposure will be forwarded to the individual.
 

3. PERSONNEL EXPOSURE GREATER THAN INVESTIGATIONAL LEVEL II.
 

The RSO will review techniques/procedures and make recommendations for reducing exposure. The RSC will review the recommendations and indicate appropriate follow-up. A written notification of the exposure will be forwarded to the individual.

C. ALARA REVIEW FORM
 

Name: SS No.:
 

Date:
 

This individual has exceeded the doses listed below.
 

ALARA Dose in mRem (mSv)/quarter
 

Level I Level II Dose Received

Whole body (Including Gonads, Lens

of Eyes, Red Bone Marrow) 125 (1.25) 375 (3.75)
 

Hands, Feet 375 (3.75) 1125 (11.25)
 

Skin of Whole Body 1250 (12.5) 3750 (37.5)
 

Reasons for excessive exposure:
 
 
 
 
 
 
 
 
 

Protective Considerations: Yes No N/A
 

1. Can time in the work area be reduced?
 

2. Will special dosimetry or area monitoring be required?
 

3. Can special tools/equipment be employed?
 

4. Can additional shielding/distance be employed?
 

Corrective action(s) taken:
 
 
 
 
 
 
 
 
 

Date Radiation Safety Officer
 
 
 

Acknowledgement
 

THIS REPORT IS FURNISHED TO YOU UNDER THE PROVISIONS OF THE LOUISIANA RADIATION PROTECTION REGULATIONS. YOU SHOULD RETAIN THIS REPORT FOR FURTHER REFERENCE.

II. RADIATION SAFETY COMMITTEE (RSC)
 

The control of radionuclides and radiation safety at Tulane University Medical Center is the responsibility of the RSC. Refer to Appendix A for a listing of the RSC members.
 

The RSC is responsible for:
 

a. Ensuring that all individuals who work with or in the vicinity of sources of radiation have sufficient training and work experience to enable them to perform their duties safely and in accordance with regulations and conditions of the license.
 

b. Ensuring that all use of sources of radiation is conducted in a safe manner and in accordance with regulations and conditions of the license.
 

The RSC shall:
 

a. Be familiar with all pertinent regulations, the terms of the license, and information in support of the request for the license and its amendments.
 

b. Review the training and experience of any individual who uses radioactive material (including physicians, technologists, physicists, and pharmacists) and determine that the qualifications are sufficient to enable them to perform their duties safely and in accordance with regulations and conditions of the license.
 

c. Establish a program to ensure that all individuals whose duties may require them to work in the vicinity of radioactive material (e.g., nursing, security and housekeeping personnel) are properly instructed.
 

d. Review and approve all requests for use of radioactive material within the institution.
 

e. 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.
 

f. Review the entire radiation safety program at least annually to determine that all activities are being conducted safely and in accordance with regulations and conditions of the license. The review shall include examination of all records, reports from the RSO, results of inspections, written safety procedures and management control systems.
 

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

h. Maintain written records of all committee meetings, actions, recommendations and decisions. Minutes of the RSC meetings shall include: the date of the meeting, listing of the members present, listing of the members absent, a summary of the deliberations, a record of the recommended actions and the numerical results of any ballots.
 

i. Ensure that the radioactive material license is amended when necessary, prior to any changes in facilities, equipment, policies, procedures and personnel.
 

j. Include representatives from Nuclear Medicine, Radiology/Radiation Oncology, Nursing, Research and Management. The RSO shall also be a member of the RSC. A quorum of the RSC must include: the RSO, a representative from management and fifty percent (50%) of all RSC members.
 

The RSC shall meet as often as necessary to conduct its business, but not less than quarterly, or as often as the Joint Commission of Accreditation of Healthcare Organizations requires (JCAHO).
 

RSC members are listed in Appendix A.

III. RADIATION SAFETY OFFICER (RSO)
 

The RSO will be responsible for radiological safety. General surveillance over all activities involving radioactive material and determining compliance with rules and regulations, license conditions and conditions or projects as approved by the RSC are the responsibilities of the RSO.
 

The RSO is responsible for providing advice regarding procurement, safe handling, monitoring, use and disposal of all radioactive sources. He will furnish in-service education on all aspects of radiation protection to personnel at all levels of responsibility.
 

The RSO will maintain records of personnel exposure, and will notify individuals of exposures approaching maximum permissible amounts. An annual inventory of all radionuclides shall be maintained in order to assure the quantity on hand has been authorized by the license.
 

The RSO shall be notified in case of accidents and shall be responsible for the primary considerations involved in the prevention of spread of contamination. The RSO shall have one or more deputies.
 

The RSO will investigate all overexposures, accidents, losses, misadministrations or other excursions from good radiation safety. The maintenance of a procedure file on all matters relating to the radionuclide program from receipt to final disposition is the responsibility of the RSO. This also includes performance checks on survey equipment as well as in-service education. The RSO will review the radiation safety program in its entirety once per year.
 

The RSO is also responsible for the accuracy and completeness of other tasks required by regulation and will verify review by his signature on key documents. This does not mean that the RSO performs tasks, but rather that the record has been reviewed. Documents requiring the signature of the RSO:
 

A. Sealed source inventory.
 

B. Sealed source wipe/leak test.
 

C. Survey of sealed source storage areas.
 

D. Dose calibrator linearity.
 

E. Dose calibrator accuracy.
 

F. Dose calibrator geometry.
 

G. The RSO will:
 

1. Ensure that surveys shall be conducted in unrestricted areas.
 

2. Maintain records of radionuclide disposal by release to sewer which shall include (a) log of sewer disposal quantities by type of radionuclide (b) the daily effluent rate (c) monthly average concentration.
 

3. Maintain records of misadministrations of radionuclides and of the corrective actions taken.
 

4. Maintain records of semi-annual fume hood flow velocity calibrations.

IV. GUIDELINES FOR NUCLEAR MEDICINE ACTIVITIES INVOLVING TECHNICIANS AND OTHER PARAMEDICAL PERSONNEL.
 

A. An authorized physician may permit technologists and other paramedical personnel to perform the following activities:
 

1. Preparation and quality control testing of radiopharmaceutical sources of radiation.
 

2. Measurements of radiopharmaceutical doses prior to administration.
 

3. Use of appropriate instrumentation for the collection of data to be used by the physician.
 

4. Administration of radiopharmaceuticals from radionuclide sources to patients, within the limits permitted under applicable laws.
 

a. Whenever a technologist or other paramedical person administers a radiopharmaceutical to a patient by injection, a physician (not necessarily the authorized user of radionuclides) shall be immediately accessible.
 

B. Authorized physicians who permit activities to be performed by technologists and other paramedical personnel shall:
 

1. Prior to such permission, determine that such technologists and other paramedical personnel have been properly trained to perform their duties. This training shall include training in the following subjects as applicable to the duties assigned:
 

a. General characteristics of radiation and radioactive material.
 

b. Physical, chemical and pharmaceutical characteristics of each radiopharmaceutical to be used.
 

c. Mathematics and calculations basic in the use and measurement of radioactivity, including units of quantity of radioactivity (Curies, millicuries, microcuries, Becquerels) and units of radiation dose and radiation exposure (Roentgens, Rad, Rem, Gray and Sievert). See Appendix JJ.
 

d. Use of radiation instrumentation for measurements and monitoring, including operating procedures, calibration of instruments and limitation of instruments.
 

e. Principles and practices of radiation protection.
 

f. Additional training in the above subjects, as appropriate, when new duties are added.
 

2. Assure that such technologists and other paramedical personnel receive appropriate retraining in the subjects listed to maintain proficiency and to keep abreast of developments in the field of nuclear medicine.
 

3. Keep records showing the bases for such determinations of proper retraining.
 

4. Retain responsibility as authorized user for the satisfactory performance of such activities. Certification in Nuclear Medicine Technology by the American Registry of Radiologic Technology (ARRT) or the Nuclear Medicine Technology Certification Board (NMTCB) will satisfy the above training requirements.
 

C. Personnel (Technologists and other paramedical) approved for radionuclide injections are listed in Appendix B.
 

V. ROUTINE FOR ORDERING, RECEIVING, OPENING PACKAGES CONTAINING RADIOACTIVE MATERIAL; PROCEDURE FOR DOCUMENTING USE OF MATERIAL
 

A. ORDERING
 

1. The Chief Technologist of the Nuclear Medicine Department will place all orders for radioactive material and will ensure that the requested materials and quantities are authorized by the Radioactive Material License (RMA). Possession limits are not to be exceeded.
 

2. A written record that identifies the radionuclide, chemical form and activity level shall be maintained.
 

3. A written request will be obtained from the physician who ordered the procedure. If a therapeutic procedure has been ordered, a written request will be obtained as well from the physician who will perform the procedure.
 

B. RECEIVING
 

1. During normal working hours, carriers will be instructed to deliver radioactive packages directly to the Nuclear Medicine Department.
 

2. During off-duty hours, security personnel or other designated individuals will accept delivery of radioactive packages in accordance with the procedures outlined in the sample memorandum, Section V.D.
 

C. MONITORING
 

Special requirements must be followed for packages containing quantities of radioactive material in excess of the Type A quantity limits, as defined in Radiation Regulations (e.g. more than 20 Curies of ⁹⁹Mo, ^99mTc, uncompressed ¹³³Xe or more than 3 Curies (3 Ci) of ¹³³Xe, ¹³¹I or ¹²⁵I. The licensee shall make arrangements to receive:
 

1. the package when the carrier offers it for delivery, or
 

2. the notification of the arrival of the package at the carrier's terminal and to take possession of the package expeditiously.
 

Such packages must be monitored for external radiation levels and surface contamination within three (3) hours after receipt if received during working hours or within eighteen (18) hours if received after working hours. The Division must be notified if removable contamination exceeds 0.01 µCi (22,000 dpm)/100 cm².
 

D. PROCEDURE FOR OPENING PACKAGES CONTAINING RADIOACTIVE MATERIAL
 

1. Put on impermeable disposable gloves to prevent hand contamination.
 

2. Visually inspect packages for any sign of damage (e.g. wetness, crushed). If damaged is noted, stop procedure and notify RSO.
 

Radiation Safety Officer: Charles F. Reindl, M.S.

Office: 584-2867

Home: 837-8516
 

Deputy Radiation Safety Officer: Michael T. Gauthier, B.S.

Office: 584-2878

Home: 738-2240
 

3. Measure the exposure rate from the package at one meter (1m) and at the package surface. If it is higher than expected, stop and notify the RSO. (The "transport index" noted on packages with "Yellow II" or "Yellow III labels is the approximate dose rate, in mR/hr at one meter (1m) from the package surface. The surface dose rate for such packages should not exceed 200 mR/hr. The dose rate from packages with "White I" labels should be less than 0.5 mR/hr at the package surface.
 

4. Open the package with the following precautionary steps:
 

1. Remove the packing slip.
 

2. Open the outer package following the suppliers' instructions, if provided.
 

3. Open the inner package and verify that the contents agree with the packing slip.
 

4. Check the integrity of the final source container. Look for broken seals or vials, loss of liquid, condensation or discoloration of the packing material.
 

5. If anything is other than expected, stop and notify the RSO.
 

5. If there is any reason to suspect contamination, wipe the external surface of the final source container and remove the wipe sample to a low-background area. Assay the wipe sample to determine if there is any removable radioactivity. The licensee should specify in the procedure manual which instrument (e.g. a thin-window G-M survey meter, a Sodium Iodide Thallium activated crystal and ratemeter, a liquid scintillation counter, or a proportional flow counter) should be used for these assays. The detection efficiency must be determined to convert wipe sample counts per minute (cpm) to disintegrations per minute (dpm). Note that a dose calibrator is not sufficiently sensitive for this measurement. Take precautions against the potential spread of contamination.
 

6. Check the user request to ensure that the material received is the material that was ordered.
 

7. Monitor the packing material and empty packages for contamination with a survey meter prior to discarding.
 

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

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

8. Record receipt of radioactive material on the proper form.
 

E. MEMO TO SECURITY
 

TO: Director of Security
 

FROM: Radiation Safety Officer
 

SUBJECT: RECEIPT OF PACKAGES CONTAINING RADIOACTIVE MATERIAL
 

Any packages containing radioactive material that arrive between 1630 hours and 0700 hours or during the weekend shall be accepted by the Security guard on duty and taken immediately to the Nuclear Medicine Department. Unlock the door, place the package on top of the counter and relock the door.
 

If the package is wet or appears to be damaged, immediately contact the Radiation Safety Officer. Ask the carrier to remain at the hospital until it can be determined that neither he/she nor the delivery vehicle is contaminated.
 

RADIATION SAFETY OFFICER: Charles F. Reindl, M.S.

Office: 584-2867
 

Home: 837-8516
 

NUCLEAR MEDICINE PHYSICIAN: Richard J. Campeau, M.D.

Office: 587-7567
 

Home: 866-6158
 

NUCLEAR MEDICINE TECHNOLOGIST: Verna Toups, R.T.

Office: 587-7567
 

F. PROCEDURES FOR DOCUMENTING USE OF RADIOACTIVE MATERIAL
 

1. A record of receipt, use, transfer, disposal and assay of all radioactive material shall be maintained for three (3) years.
 

2. See Appendices C-F for appropriate forms.

VI. INSTRUCTIONS FOR ADMINISTRATION OF RADIOPHARMACEUTICALS FOR DIAGNOSTIC AND THERAPEUTIC PROCEDURES
 

A. Before writing a prescription, the authorized user or physician under the supervision of an authorized user will personally review the patient's case to establish that the medical use is indicated for the patient.
 

B. Before administering a radiopharmaceutical, the authorized user or the physician under the supervision of an authorized user will personally make and date a prescription. If changes are required, they will be recorded in writing in the patient's chart or in another appropriate record, and will be dated and signed.
 

C. Before administering a radiopharmaceutical, the identity of the patient, the radiopharmaceutical, and the dosage will be confirmed by the person administering the radiopharmaceutical to establish agreement with the prescription. Any dose that differs from the prescribed dose by more than ten percent (10%) shall not be administered.
 

D. ASSAY OF RADIOPHARMACEUTICAL DOSAGES
 

1. Assay, within thirty (30) minutes before medical use, the activity of each radiopharmaceutical dosage that contains more than 10 µCi (370 kBq) of a photon-emitting radionuclide.
 

E. RECORD REQUIREMENTS
 

Retain a record of assays three (3) years. To satisfy this requirement, the record shall contain the following:
 

1. The patient's name and identification number (if one has been assigned).
 

2. The generic name or trade name, radiopharmaceutical abbreviation, lot number and expiration date of the radiopharmaceutical.
 

3. The prescribed dosage and activity of the dosage at the time of assay, or a notation that the total activity is less than 10 µCi (370 kBq).
 

4. The date and time of administration of the radiopharmaceutical.
 

5. The initials of the individual who performed the assay.
 

VII. LABORATORY RULES FOR USE OF RADIOACTIVE MATERIAL
 

A. Wear laboratory coats or other protective clothing at all times in areas where radioactive materials are used.
 

B. Wear impermeable disposable gloves at all times while handling radioactive material.
 

C. Monitor hands and clothing for contamination after each procedure or before leaving the area.
 

D. Use syringe shields for preparation of patient doses and administration to patients, except in circumstances (e.g. pediatric cases) where their use would compromise the patient's well-being.
 

E. Do not eat, drink, smoke or apply cosmetics in any area where radioactive material is being stored or used.
 

F. Do not pipette by mouth.
 

G. Assay each patient dose in dose calibrator prior to administration. Do not use any dose that differs from the prescribed dose by more than ten percent (10%). Check the patient's name and identification number and the prescribed radionuclide, chemical form and dosage prior to administration.
 

H. Wear personnel monitoring devices (film badge or thermoluminescent dosimeter [TLD]) at all times while in areas where radioactive materials are used or stored. These should be worn on the lapel. When not being worn to monitor occupational exposures, personnel monitoring devices should be stored in the work place in a designated low-background area.
 

I. Wear a ring badge when:
 

1. Eluting a generator
 

2. Preparing Kits (Radionuclide labeling)
 

3. Injecting mCi activities
 

4. When holding patients during procedures
 

J. Dispose of radioactive waste only in specifically designated, labeled and properly shielded receptacles.
 

K. Use plastic backed absorbent paper to cover the work area to absorb radioactive material in the event of a spill.
 

L. Confine the radioactive solutions in shielded containers that are clearly labeled. Radiopharmaceutical multidose diagnostic vials and therapy vials should be labeled with the isotope, the name of the compound, the date and time of receipt or preparation. A log book should be used to record the preceding information and total prepared activity, assay in mCi/cc at a specific time, total volume prepared, total volume remaining, the measured activity of each patient dosage and any other appropriate information. Syringes and unit dosages should be labeled with the radiopharmaceutical name or abbreviation, type of study or patient's name and identification number.
 

M. Always transport radioactive material in shielded containers.
 

N. Always keep flood sources, syringes, waste and other radioactive material in shielded containers.
 

O. Perform required Radiation Area and Contamination Surveys. See page XI-1.
 

P. The spread of contamination is a matter of good housekeeping.
 

1. Keep the laboratory neat and clean. Keep the work area free of equipment and material not required for the immediate procedure.
 

2. Wash hands and arms thoroughly before handling any object which goes to the mouth, nose or eyes. Monitor the hands whenever contamination is suspected and decontaminate immediately.
 

3. Keep fingernails short and clean. Do not work with radioactive material if there is a break in the skin below the wrist unless the wound is so protected that radioactive material cannot gain access to the body. Cover the break with an appropriate bandage (plastic or adhesive) and wear impermeable disposable gloves.
 

4. Food containers are not permitted in the laboratory. Refrigerators should not be used jointly for food and radioactive material storage.
 

Q. Radioactive Specimens, Excreta or Body Fluids
 

1. Excreta and Body Fluids may be disposed in the sanitary sewer.
 

2. Specimens shall be labelled with the radionculide, activity in µCi, date and special instructions to the pathologist.
 

3. All waste shall be disposed in accordance with Section XX of the RSM.
 

VIII. RESTRICTION AND LABELING OF RADIATION AREAS
 

A. All radiation areas are to be properly labeled and as such are to be restricted from entrance by unauthorized personnel.
 

B. A sign bearing the radiation caution symbol and the words "Caution High Radiation Area" will be posted when the level is such that a major portion of the body could receive in any one (1) hour a dose in excess of 100 mR (1 mSv).
 

C. A sign bearing the radiation caution symbol and the words "Caution Radiation Area" will be posted when the level is such that a major portion of the body could receive in any one (1) hour a dose in excess of 5 mR (0.05 mSv) or 100 mR/five (5) days.
 

D. A sign bearing the radiation caution symbol and the words "Caution Airborne Radioactivity Area" will be posted in any room, enclosure or operating area which has airborne radioactive materials in excess of the amounts specified in radiation regulations.
 

E. A sign bearing the radiation caution symbol and the words "Caution Radioactive Materials" will be displayed in all rooms and on containers in which radioactive material is stored or used.
 

F. "Notice to Employees will be posted in areas utilizing radioactive materials. See Appendix J.
 

IX. PERSONNEL MONITORING POLICY
 

A. REQUIREMENTS FOR MONITORING INDIVIDUALS
 

Personnel Monitoring is recommended for individuals for whom there is a reasonable probability of exceeding ten percent (10%) of the occupational dose equivalent limit of 5 rems/yr (50 mSv/yr) in the course of their work.
 

Personnel who work with radiation sources and may exceed ten percent (10%) of the occupational dose equivalent limit shall wear a personnel monitoring device (film badge or TLD) to assess actual exposure during work or as a check against unplanned exposures.
 

B. LOCATION OF PERSONNEL MONITORING DEVICE
 

All personnel monitoring devices are to be worn at the lapel. Whenever protective lead aprons are worn, the personnel monitoring devices shall be worn on the outside of the apron at the lapel.
 

For DECLARED PREGNANT WOMEN, a second personnel monitoring device shall be issued. The personnel monitoring device shall be worn at the waist under any protective apron in order to monitor embryo/fetal radiation dose.
 

C. RING BADGES
 

Any individual eluting a generator, preparing kits, injecting doses in the mCi or larger range or individuals performing invasive radiological procedures in which the hands of the individual could inadvertently become exposed to direct radiation shall be issued a ring badge for extremity (hand) monitoring.
 

D. EXCHANGE
 

Personnel monitoring devices and ring badges shall be exchanged at monthly intervals. All monitoring devices shall be returned no later than two (2) days after issue of new monitoring devices. New monitoring devices shall be worn within ±two (2) days of issue date.
 

E. ISSUE OF PERSONNEL MONITORING DEVICES; MAINTENANCE OF RECORDS
 

The RSO or Deputy RSO shall issue all personnel monitoring devices and (2) maintain results of monthly and annual dose summaries for all monitored individuals
 

F. THYROID MONITORING
 

Individuals involved in vented operations which utilize, at any one time, more than one millicurie (1 mCi) of ¹²⁵I and/or ¹³¹ or unvented laboratory operations involving 0.1 mCi of ¹²⁵I and/or ¹³¹I in an aqueous form shall have bioassays performed within 72 hours following a single operation and every two (2) weeks if use of these amounts continue. Records of the bioassay shall be maintained for inspection by the RSO and the action point listed below shall be observed.
 

INITIAL ACTION LEVEL: Greater than 0.12 µCi of 125I or 0.04 µCi of ¹³¹
 

IF INITIAL ACTION LEVEL IS EXCEEDED
 

a. An investigation of the operations involved, including air sampling surveys to determine the causes of exposure and to evaluate the potential for further exposures.
 

b. If investigation indicates, the licensee shall restrict the worker from further exposure until the source of exposure is discovered and corrected.
 

c. Corrective actions that will eliminate or lower the potential for further exposures shall be implemented.
 

d. A repeat bioassay shall be taken within two (2) weeks of the previous measurement in order to confirm the effectiveness of the corrective action taken and to obtain an estimate of effective half-life.
 

e. Reports or notification shall be provided as required by Radiation Regulations.
 

FINAL ACTION LEVEL: Greater than 0.5 µCi of ¹²⁵I or 0.14 µCi of ¹³¹I.
 

IF FINAL ACTION LEVEL IS EXCEEDED
 

a. Prevent the individual from any further handling of ¹²⁵ or ¹³¹I until the thyroid burden is below the limits.
 

b. As soon as possible, refer the case to appropriate medical consultant for recommendations regarding therapeutic procedures in order to accelerate removal of radioactive iodine from the body. This should be done within two to three (2-3) hours after exposure when the time of exposure is known so that any prescribed thyroid blocking agent would be effective.
 

c. Carry out repeated measurements at approximately one (1) week intervals until the thyroid is less than 0.12 µCi of ¹²⁵I or 0.04 µCi of ¹³¹I.
 

Individuals involved in administration of encapsulated ¹²⁵I and/or ¹³¹I shall not require thyroid monitoring unless the integrity of the capsule is broken. If this occurs, Section F.1 shall be observed.
 

X. LIMITS FOR EXPOSURE TO IONIZING RADIATION:
 

Summary of Recommendations^ab
 

A. Occupational exposures (annual)^c
 

1. Effective dose equivalent limit

(stochastic effects) 50 mSv (5 rem)
 

2. Dose equivalent limits for

tissues and organs (nonstochastic

effects)
 

a. Lens of eye 150 mSv (15 rem)
 

b. All others (e.g. red bone

marrow, breast, lung, gonads,

skin and extremities) 500 mSv (50 rem)
 

3. Guidance: Cumulative exposure 10 mSv x age (1 rem x age)
 

B. Planned special occupational exposure,

effective dose equivalent limit 100 mSv (10 rem)
 

C. Guidance for emergency occupational

exposure 100 mSv (10 rem)
 

D. Public exposures (annual)
 

1. Effective dose equivalent limit,

continuous or frequent exposure^c 1 mSv (0.1 rem)
 

2. Effective dose equivalent limit,

infrequent exposure^c 5 mSv (0.5 rem)
 

3. Remedial action recommended when:
 

a. Effective dose equivalentd >5 mSv (>0.5 rem)
 

b. Exposure to radon and its

decay products >0.007Jhm-3 (>2 WLM)
 

4. Dose equivalent limit for lens

of eye, skin and extremities 50 mSv (5 rem)
 

E. Education and training exposures (annual)^c
 

1. Effective dose equivalent limit 1 mSv (0.1 rem)
 

2. Dose equivalent limits for lens

of eye, skin and extremities 50 mSv (5 rem)
 

F. Declared Pregnant Females (Embryo-fetus exposures)
 

1. Total dose equivalent limit 5 mSv (0.5 rem)
 

2. Dose equivalent limit in a month 0.5 mSv (0.05 rem)
 

G. Negligible Individual Risk Level (annual)^c
 

1. Effective dose equivalent per source or

practice 0.01 mSv (0.001 rem)
 
 
 

^aExcluding medical exposures.
 

^bSee below for recommendations on Q.
 

^cSum of external and internal exposures.
 

^dIncluding background but excluding internal exposures.
 

RECOMMENDED VALUES OF Q FOR VARIOUS TYPES OF RADIATION
 

Type of radiation Approximate value of Q
 

X rays, rays, particles and electrons 1
 

Thermal neutrons 5
 

Neutrons (other than thermal), protons, alpha

particles and multiple-charged particles of unknown energy 20
 

XI. RADIATION AND CONTAMINATION AREA SURVEYS
 

A. All elution, preparation, and injection areas will be surveyed with a low range thin window G-M survey meter and decontaminated if necessary. NOTE: Each survey meter instrument shall be checked for proper operation with a dedicated check source before each use. Records of these checks are not required.
 

B. All areas where radionuclides are routinely prepared for use or administered shall be surveyed at the end of each day of use.
 

C. All areas where radionuclides are routinely prepared for use or administered including radionuclide storage locations shall be surveyed for removable contamination at the end of each week of use.
 

D. Measurement of radiation levels with the survey meter shall be sufficiently sensitive to detect 0.1 mR/hr.
 

The method for performing wipe tests will be sufficiently sensitive to detect 37 Bq/100 cm² (.001 µCi) for the contaminant involved.
 

E. A record will be kept of all survey results, including negative results. The record shall be maintained for three (3) years and will include:
 

1. Location, date and type of equipment used.
 

2. Name of person conducting the survey.
 

3. Drawing of area surveyed, identifying relevant features such as active storage areas, active waste areas, etc.
 

4. Measured exposure rates keyed to location on the drawing and at least one reading in an unrestricted area.
 

5. Detected contamination levels, keyed to locations on the drawing.
 

6. Corrective action taken in the case of contamination or excessive exposure rates, reduced contamination levels or exposure rates after corrective action, and any appropriate comments.
 

F. The area shall be considered contaminated if the ACTION LEVELS below are exceeded. The RSO shall be notified immediately if direct survey or contamination action levels are exceeded.
 

ACTION LEVEL Direct Survey: 2 X Bkg. @ Surface
 

ACTION LEVEL Removable Contamination: 37 Bq(0.001 µCi)
 

XII. DECONTAMINATION PROCEDURES
 

A. GENERAL CONSIDERATIONS
 

1. Prevent spread of contamination: The RSO should be called for assistance as soon as possible whenever a spill occurs. The first consideration shall include tracking by persons, movement by air currents (hoods, fans, etc.), water, mopping and other physical actions. To confine it, decontaminate spill from outside toward center.
 

2. Make a plan: Successful decontamination calls for planned action. A spur of the moment action or attempt at decontamination can cause more harm than good. The best thing to do after a spill is make a thorough plan of the steps to be taken in the decontamination procedure.
 

3. Monitoring: Make full use of instruments and available assistance. Each step of the decontamination should be monitored. One person should be kept clean to operate instruments and do other monitoring. When instruments become contaminated, any progress is hopeless. Protective clothing, footwear, gloves and assault masks should be used as needed.
 

4. Records: Complete records should be made of each action. Copies should be sent to the RSO. In most cases, the RSO will be involved in the clean-up, thus a joint report can be filed.
 

5. Waste disposal: Provisions must be made for disposal of cleaning solutions and contaminated articles. In some instances, it may be judged better to dispose of a contaminated article rather than to attempt to decontaminate.
 

B. SPECIFIC PROCEDURES
 

1. Skin and hands as contaminated areas.
 

a. Decontaminating agent - mild soap and water or detergent and water. If necessary, follow by soft brush, heavy lather and tepid water.
 

b. Remarks - Wash two to three (2 - 3) minutes and monitor. Do not wash over three (3) or four (4) times. Use light pressure with heavy lather. Wash for two (2) minutes, three times. Rinse and monitor. Use care not to scratch or erode skin.
 

c. Maximum permissible levels of contamination:
 

Alpha - 150 dpm/100 cm²
 

Beta-Gamma - Average less than 0.3 mR/hr for each hand surface or 100 cm² of skin surface, using GM survey meter.
 

2. Wounds (cuts and breaks in skin)
 

a. Decontaminating agent - running tap water. Report to physician and RSO.
 

b. Remarks - wash wound with large volumes of running water. Spread wound to permit flushing action by water.
 

c. Maximum permissible levels of contamination - keep wound contamination as low as possible.
 

3. Ingestion by swallowing
 

a. Decontaminating agent - immediately induce vomiting. Drink large quantities of liquids to dilute activity.
 

b. Remarks - urine and feces analysis will be necessary to determine amount of radionuclides in body.
 

XIII. CONTAMINATED EQUIPMENT
 

A. Radioactive contamination is defined as the deposition of radioactive material in any place where it is not desired and particularly in any place where its presence may be harmful. Under no circumstances shall contaminated equipment be in the laboratory or be returned to a stock room.
 

B. Equipment that may be reused should be decontaminated.
 

C. Contaminated equipment which is no longer of any use may be discarded in the dry active waste can. If too large for such disposal, request a survey and disposal information from the RSO.
 

D. Equipment to be repaired by shop and maintenance personnel or by a commercial contractor shall be demonstrated to be free of contamination prior to servicing.
 

E. If it becomes necessary to make emergency repairs on contaminated equipment, the work will be supervised by the RSO who will assure that the necessary safeguards are taken. It is the responsibility of the laboratory personnel to request this supervision.
 

XIV. EMERGENCY PROCEDURES
 

A. WHOM TO CALL
 

In the event of an emergency, i.e., spills, bodily injury and contamination involving a radiation source, fires, etc., notify the RSO.
 

RSO: Charles F. Reindl, M.S.

Office: 584-2867

Home: 837-8516
 

Deputy RSO: Michael T. Gauthier, B.S.

Office: 584-2878

Home: 738-2240
 

In addition, each particular lab should have posted the location of the nearest fire alarm and the phone number of the Fire Department.
 

B. LOSS OF SOURCE
 

Immediately upon discovery of a loss of a sealed source, an appropriate plan of action should be initiated. An example of such a plan would be as follows:
 

1. Call the RSO immediately.
 

2. Make a list of all possible places in which the source might have been and where it might be found.
 

3. Choose the most sensitive and appropriate portable survey instruments (e.g. mR meters or portable scintillation detectors for gamma or high energy beta emitters) for conducting the search.
 

4. If the source had been transported, check the entire route of travel;
 

5. If the source had been used with a patient, survey the patient, the patient's room and all bandages, linen, bedding and trash from the patient's room.
 

6. Survey the entire route from the patients room to the laundry and the laundry facility.
 

7. Survey the entire route from the patient's room to the incinerator, the incinerator, trash awaiting incineration and the incinerator ash.
 

8. Survey the entire route from the patient's room to the dumpster and the trash in the dumpster. If needed, request Security to impound the dumpster until the search can be completed.
 

9. If instruments had been used with the patient, survey the entire route from the patient's room to the instrument cleaning and sterilization areas.
 

10. Survey all areas where the source might be found, such as sink drains or plumbing fixtures, elevator shafts, waste cans, trash bins and vacuum cleaners or house vacuum systems.
 

11. Continue the search until the source is found or the search is terminated by the RSO.
 

12. The RSO shall notify the Radiation Protection Division.
 

C. STORAGE IN ANTICIPATION OF NATURAL CATASTROPHY
 

In the event of hurricane, flooding or other disaster, all radioactive material should be returned to the storage site. Individual amounts of material should be stored in double containers and sealed as well as possible to prevent leakage. Each container should be labeled with the name of the radionuclide, its chemical form and activity present on a specified date. The storage safe or cabinet should be locked and sealed with waterproof tape. If time permits, a list of the radionuclides placed in the storage area should be posted with the date and activity present. If a suitable storage area does not exist, contact the RSO.
 

D. MINOR SPILLS
 

1. NOTIFY: All persons in the area that a spill has occurred.
 

2. PREVENT THE SPREAD: Cover the spill with absorbent paper.
 

3. CLEAN UP: Use disposable gloves and remote handling tongs. Carefully fold the absorbent paper and pad. Insert into a plastic bag and dispose of in the radioactive waste container. Include all other contaminated materials such as impermeable disposable gloves.
 

4. SURVEY: With a G-M survey meter, check the area around the spill, hands, clothing and shoes for contamination.
 

5. REPORT: Report incident to the RSO.
 

E. MAJOR SPILLS
 

1. CLEAR THE AREA: Notify all persons not involved in the spill to vacate the room.
 

2. PREVENT THE SPREAD: Cover the spill with absorbent pads; do not attempt to clean. Confine the movement of all personnel potentially contaminated to prevent the spread.
 

3. SHIELD THE SOURCE: If possible, the spill should be shielded, but only if it can be done without further contamination or increased radiation exposure.
 

4. VENTILATION SYSTEM: Switch off all fans and air conditioners.
 

5. CLOSE THE ROOM: Leave the room and lock the door(s) to prevent entry.
 

6. CALL FOR HELP: Notify the RSO immediately.
 

7. PERSONNEL DECONTAMINATION: Contaminated clothing should be removed and stored for further evaluation by the RSO. If the spill is on the skin, flush thoroughly and wash with mild soap and tepid water.
 

F. ACCIDENT INVOLVING RADIOACTIVE DUSTS, MISTS, FUMES, ORGANIC VAPORS AND GASES
 

1. NOTIFY all other persons to vacate the room immediately.
 

2. HOLD BREATH and close return air vents, switch off air circulating devices, etc., if time permits.
 

3. VACATE the room.
 

4. NOTIFY the RSO.
 

5. Ascertain that all DOORS GIVING ACCESS TO THE ROOM ARE CLOSED and post conspicuous warnings or guards to prevent accidental opening of doors.
 

6. REPORT at once all known or suspected inhalations of radioactive material.
 

G. INJURIES TO PERSONNEL INVOLVING RADIATION HAZARD
 

1. WASH MINOR WOUNDS immediately under running water while spreading the edges of the wound.
 

2. REPORT all radiation accidents involving personnel (wounds, overexposures, ingestion, inhalation) to the RSO.
 

3. CALL A PHYSICIAN qualified to treat radiation injuries.
 

4. Permit no person involved in a radiation injury to return to work without approval of the RSOfficer and attending physician.
 

H. FIRES
 

1. FOLLOW "FIRE" PROCEDURE in Emergency Preparedness Manual.
 

2. NOTIFY the RSO.
 

3. GOVERN THE FIRE-FIGHTING OR OTHER EMERGENCY EQUIPMENT observing restrictions of the RSO.
 

4. Following the emergency, monitor the area and determine the protective devices necessary for safe decontamination.
 

5. Decontamination shall be supervised by the RSO.
 

XV. INSTRUCTION FOR MAINTENANCE
 

A. Maintenance personnel should enter the laboratories employing radioactive sources only for authorized and necessary purposes.
 

B. When radioactive sources are properly stored, it is not dangerous to enter these areas. If in doubt concerning hazards present, contact the RSO.
 

C. General maintenance work may be performed only when all radioactive materials have been returned to their shielded containers. Contact the technologist before initiation of cleaning or general maintenance work.
 

D. If sign below is posted, entry is prohibited.
 

E. Maintenance personnel shall notify the RSO before any alterations to shielding or to shielded areas.
 

XVI. INSTRUCTIONS FOR HOUSEKEEPING
 

Radiation, as we know it today, is found in many forms and amounts. Radiation has always been present to some degree in nature, our food, building materials and our bodies. Even though levels of radioactivity in most areas are very low, personnel should use caution and have respect for the possible hazard. As part of this caution:
 

A. DO observe warning signs.
 

B. DO report to your supervisor anything you think is not right.
 

C. DO NOT empty waste cans labeled with the radiation sign.
 

D. DO NOT dispose of any packages or other containers labeled with an undefiled radiation sign. If you are in doubt, contact your supervisor.
 

E. DO NOT clean any spills, either wet or dry, in areas that use radioactive material, until you have been assured that the spill is not radioactive.
 

F. DO NOT handle or move containers with the radiation sign.
 

G. DO contact the RSO if you have any questions or concerns.
 

XVII. ESCORT PERSONNEL
 

Prior to transporting a patient with an implanted radioactive source, the escort should be informed of the location of the implanted source. The escort should be given a personnel monitoring device to wear and should be instructed on its use. Escort personnel should observe the following:
 

A. Minimize their exposure by staying as far from the source as is possible while transporting the patient (unless otherwise advised by the RSO or the medical staff individual assisting the patient).
 

B. Use designated patient elevators.
 

C. If public elevators are used, the general public should be excluded.
 

D. The least crowded corridors should be selected for passage.

XVIII. INSTRUCTIONS FOR VISITORS
 

A. No visitors are permitted in any laboratory using a radiation source unless accompanied by a qualified individual familiar with the hazards involved.
 

B. All visitors shall be issued a personal monitoring device when they enter an area in which radioactive materials are located in such amounts that they constitute a potential personal hazard or increase the possibility of spread of contamination. Accumulated doses shall be recorded for the visitor along with the individual's name, age and address. This information shall be sent in a written memorandum to the RSO to be kept on file.
 

C. Pregnant female visitors shall not be permitted in laboratories using a radiation source.
 

XIX. STORAGE OF RADIONUCLIDES
 

All areas where radioactive materials are used and stored shall be locked when not attended by authorized personnel.
 

A. LIQUIDS AND SOLIDS
 

1. All radioactive samples must be clearly labeled at all times with pertinent information about the contents, such as the name of the isotope, its chemical form and the quantity of radioactive material as well as the name of the responsible individual.
 

2. Storage sites for large amounts of radioactive material should be as remote from occupied areas as is practical.
 

3. The background radiation in unrestricted areas shall be such that individuals continuously present in the area will not receive a dose in excess of 2 mR in any one hour or will not receive a dose in excess of 100 mR in any seven (7) consecutive days. The whole body exposure in unrestricted areas shall be such that any individual will not receive a dose in excess of 0.5 rem in any period of one (1) calendar year.
 

4. The storage place should be chosen as to minimize risk from fire. The storage place should have a suitable means of egress.
 

5. The storage areas shall be well marked with a "Caution Radioactive Materials" sign. If necessary, entrance requirements shall be posted.
 

B. GASES
 

1. The general storage requirements listed above apply as well as the following considerations:
 

a. Radioactive solutions that emit gases shall be labeled and kept in approved hoods which are provided with filters and have adequate ventilation.
 

b. In general, only such amounts of material as are necessary for immediate experiments or diagnostic exams should be stored in the laboratory area.
 

c. For maximum permissible concentrations in air, consult the RSO.
 

XX. RADIONUCLIDE DISPOSAL
 

The following general guideline and procedure may be used for disposal of radioactive waste.
 

There are four (4) commonly used methods of waste disposal: (1) release to the environment through the sanitary sewer or by evaporative release (2) decay-in-storage (DIS) (3) transfer to a burial site or back to the manufacturer and (4) release to in-house waste. With the exception of patient excreta and generally licensed in vitro kit exemptions, nothing in these guidelines relieves the licensee from maintaining records of the disposal of licensed material.
 

A. GENERAL GUIDANCE
 

1. Follow "UNIVERSAL PRECAUTIONS" while handling all waste.
 

2. Records of all amounts in µCi of all radionuclides must be maintained.
 

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

4. Remind employees that nonradioactive waste such as leftover reagents, boxes and packaging material should not be mixed with radioactive waste.
 

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

6. In all cases, consider the entire impact of various available disposal routes. Consider occupational and public exposure to radiation, other hazards associated with the material and routes of disposal (e.g, toxicity, carcinogenicity, pathogenicity, flammability and expense).
 

B. PROCEDURE FOR DISPOSAL OF LIQUIDS AND GASES
 

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

1. Material must be readily water soluble or readily dispersible biological material in water. There are monthly limits based on the total sanitary sewerage release of your facility. (Excreta from patients undergoing medical diagnosis or therapy is exempt from all the above limitations). Make a record of the date, radionuclide and estimated activity that was release in µCi of mCi and of the sink or toilet at which the material was released.
 

2. Limits on permissible concentrations in effluents to unrestricted areas are enumerated in the regulations. These limits apply at the boundary of the restricted area. Make a record of the date, radionuclide, estimated activity that was released in µCi or mCi and of the vent site at which the material was released.
 

C. PROCEDURE FOR DISPOSAL BY DECAY-IN-STORAGE (DIS)
 

Short-lived material (physical half-life less than 65 days) may be disposed of by DIS. If you use this procedure, keep material separated according to half-life.
 

1. Use separate containers for different types of waste, e.g., capped needles and syringes in one container, other injection paraphernalia such as swabs and gauze in another, and unused dosages in a third container. Smaller departments may find it easier to use just one container for all DIS waste. Because the waste will be surveyed with all shielding removed, the containers in which waste will be disposed of must not provide any radiation shielding for material.
 

2. When the container is full, seal it with tape and attach an identification tag that includes the date sealed, the longest-lived radioisotope in the container and the initials of the individual sealing the container. The container may then be transferred to the DIS area.
 

3. Decay the material for at least ten (10) half-lives.
 

4. Prior to disposal as in-house waste, monitor each container as follows:
 

a. Check your radiation detection survey meter for proper operation.
 

b. Plan to monitor in a low-level (<0.05 mR/hr) area.
 

c. Remove any shielding from around the container.
 

d. Monitor all surfaces of each individual container.
 

e. Discard as in-house waste only those containers that cannot be distinguished from bkg. Record the date on which the container was sealed, the disposal date and type of material (e.g., paraphernalia, unused dosages). Check to be sure no radiation labels are visible.
 

f. Containers that can be distinguished from background radiation levels must be returned to the storage area for further decay or transferred for other disposal.
 

5. If possible, 99Mo/99mTc generators should be held 60 days before being dismantled due to the occasional presence of a long-lived contaminant. When dismantling generators, keep a radiation detection survey meter (preferable with a speaker) at the work area. Dismantle the oldest generator first, then work forward chronologically. Hold each individual column in contact with the radiation detection survey meter in a low-background (<0.05 mR/hr) area. Log the generator date and disposal date for your waste disposal records. Remove or deface the radiation labels on the generator shield.
 

D. PROCEDURE FOR TRANSFER FOR BURIAL
 

Except for material suitable for DIS and some animal carcasses, solids must be transferred to a burial site. Follow the packaging instructions you received from the transfer agent and the burial site operator. For your records of disposal, keep the consignment sheet that the transfer agent remitted to you.
 

E. PROCEDURE FOR RETURNING GENERATORS TO THE MANUFACTURER
 

Used 99Mo/99mTc generators may be returned to the manufacturer. This permission dose not relieve the licensee from the requirement to comply with Department of Transportation (DOT) regulations.
 

1. Retain the records needed to demonstrate that the package qualifies per DOT regulations.
 

2. Assemble the package in accordance with the manufacturer's instructions.
 

3. Perform the dose rate and removable contamination measurements.
 

4. Label the package and complete the shipping papers in accordance with the manufacturer's instructions.
 

F. TRANSFER TO UNIT DOSE PHARMACY OR COMMERCIAL DISPOSAL AGENCY
 

1. Only unused doses, oral therapy doses and containers and bulk ^99mTc may be returned to the pharmacy.
 

2. Brachytherapy sources may be transferred to supplier provided DOT regulations are satisfied.
 

3. Records shall be maintained of amounts of radioactive materials transferred to commercial disposal agency licensed to receive radioactive waste materials.
 

G. SPECIFIC WASTES
 

1. BACTEC ¹⁴C TEST VIALS
 

a. Autoclave all vials to destroy pathogens.
 

b. Liquids may be disposed via sanitary sewer system. On no single day will more than 1 mCi be released in the sewer system. Over a period of one (1) month, the activity released, when diluted by the average monthly quantity of water, will not exceed a concentration of 3X10^-4 µCi/ml of ¹⁴C.
 

c. After autoclaving and rinse, the vials shall be placed in plastic bags for disposal with other laboratory waste material.
 

d. Care should be exercised to protect vials from breakage during autoclaving and rinsing procedures.
 

e. Vials may alternatively be incinerated.
 

2. ³H, ¹⁴C
 

a. 0.05 µCi or less of the above radioactive material/g of medium used for scintillation counting may be disposed without regard to radioactivity providing that all regulations governing any other toxic or hazardous property of these materials are observed.
 

H. INFECTIOUS, HIGHLY TOXIC, HAZARDOUS SUBSTANCES
 

a. Plans for proper disposal of infectious agents, highly toxic and/or hazardous substances shall be made early in the design stage of an experiment. Proposed procedures involving unusual problems will be considered individually by the RSC.
 

I. INCINERATION
 

Radioactive waste is accepted in Room 1105 of the Medical School, Tuesday and Thursday from 8:30 to 10:30 a.m.
 

In order to ensure that air activity limits for unrestricted areas are not exceeded, limits on activity incinerated per hour are imposed based on the following equation: 2858 cfm X 60 min/hr X 28,320 ml/cubic foot = 4.85 X 10⁹ ml/hr. For example, the maximum concentration of H-3 in unrestricted air = 1 X 10^-7 µCi/ml; 1 X 10^-7 µCi/ml X 4.85 X 10⁹ ml/hr = 485 µCi/hr; other radionuclides are limited by use of the same equation: maximum concentration X 4.85 X 10⁹ ml/hr = allowable burn/hr.
 

A sample of the resulting ash from the ash bin must be collected and analyzed for the radionuclide(s) burned. The ash must not be released until it is at or below the effluent concentration limit for water. Ash may be held until a decay calculation yields an activity concentration at or below this limit. If this is not possible, the ash must be packaged for disposal as radioactive waste.
 

The activity amount of each radionuclide burned must be totalled and divided by the total activity amount allowed to be burned during that time period. This fraction is equivalent to Concentration in Air/Maximum Allowable Concentration. The fraction for each isotope must be totalled and recorded. Although unity may be exceeded during some weeks, the average for the year shall not exceed unity.
 

XXI. SAFETY RULES: FIXED RADIOGRAPHIC
 

A. Particular care should be taken to limit the useful beam to the smallest area consistent with clinical requirements and to align accurately the X-ray beam with the patient and film.
 

B. Gonadal shielding should be used for the patient when appropriate, but never as a substitute for adequate beam collimation and alignment.
 

C. When a patient must be held in position for radiography, mechanical supporting or restraining devices should be used. If the patient must be held by an individual, that individual shall be protected with appropriate shielding devices, such as protective gloves and apron. The individual should be so positioned that no part of his body will be struck by the useful beam and that his body is as far as possible from the edge of the useful beam.
 

D. Special precautions, consistent with clinical needs, should be taken to minimize exposures of the embryo or fetus in patients known to be or suspected of being pregnant.
 

E. Use the maximum source-skin distance consistent with the conditions of the examination.
 

F. Only persons whose presence is necessary shall be in the radiographic room during exposure. All such persons shall be protected.
 

G. The radiographer shall stand behind the barrier provided for his/her protection during radiographic exposures.
 

H. Special care shall be taken to insure adequate filtration in multi-purpose machines. Particular care shall be taken to insure adequate filtration in any machine equipped with a beryllium window tube.
 

XXII. SAFETY RULES: FIXED FLUOROSCOPIC
 

A. Particular care should be taken to limit the useful beam to the smallest area consistent with clinical requirements and to align accurately the X-ray beam with the patient and film.
 

B. Gonadal shielding should be used for the patient when appropriate, but never as a substitute for adequate beam collimation and alignment.
 

C. When a patient must be held in position for radiography, mechanical supporting or resteraining devices should be used. If the patient must be held by a individual, that individual shall be protected with appropriate shielding devices, such as protective lead gloves and an apron. The individual should be so positioned that no part of his body will be struck by the useful beam and that his body is as far a possible from the edge of the useful beam.
 

D. Special precautions, consistent with clinical needs, shold be taken to minimize exposures of the embryo or fetus in patients know to be or suspected of being pregnant.
 

E. Use the maximum source-skin distance consistent with the conditions of the examination.
 

F. Protective aprons of at least 0.5 mm lead equivalent should be worn in the fluoroscopy room by each person (except the patient). X-ray monitoring devices shall be worn by all persons in the X-ray room (except the patient) on the outside of the protective apron on the lapel.
 

G. Only persons whose presence is required shold be in the fluoroscopic room.
 

H. The hand of the fluoroscopist shold not be placed in the useful beam unless the beam is attenuated by the patient and a protective glove of at least 0.5 mm lead equivalent.
 

I. Fluoroscopy should not be utilized as a substitute for radiography. Fluoroscopy is to be reserved for the study of dynamics, special relationships or guidance in spot filming of critical details.
 

J. In cineradiography, special care must be taken to limit patient exposure when, as is often the case, tube currents and potentials employed are higher than those normally used in fluoroscopy.
 

K. Image intensification shall always be provided on mobile fluoroscopic equipment. It shall be impossible to operate mobile fluoroscopic equipment unless the useful beam is intercepted by the image intensifier.
 

XXIII. SAFETY RULES: OPERATORS OF MOBILE RADIOGRAPHIC EQUIPMENT
 

A. Particular care should be taken to limit the useful beam to the smallest area consistent with clinical requirements and to align accurately the X-ray beam with the patient and film.
 

B. Gonadal shielding should be used for the patient when appropriate, but never as a substitute for adequate beam collimation and alignment.
 

C. When a patient must be held in position for radiography, mechanical suppoorting or restraining devices should be used. If the patient must be held by an individual, that individual shall be protected with appropriate shielding divices, such as protective lead gloves and an apron. The individual should be so positioned that no part of his body will be struck by the useful beam and that his body is as far as possible from the edge of the useful beam.
 

D. Special precautions, consistent with clinical needs, should be taken to minimize exposures of the embryo or fetus in patients known to be or suspected of being pregnant.
 

E. Use the maximum source-skin distance consistent with the conditions of the examination.
 

F. Mobile X-ray equipment shall not be used for fluoroscopy, unless it meets the requirements for mobile fluoroscopes.
 

G. Mobile equipment should be used only for examinations where it is impractical to transfer patients to permanent radiographic installations.
 

H. Patients in adjoining beds should be at least twelve (12) feet away from the central ray of the primary beam. If the beds cannot be moved, adjacent patients shall be furnished with a 0.5 mm lead equivalent apron.
 

I. Prior to making the X-ray exposure, the technologist will announce his/her intention to do so. No exposure is to be made if any person, other than the patient is within a twelve (12) foot radius of the X-ray beam and is not properly shielded.
 

XXIV. SAFETY RULES: OPERATORS OF MOBILE FLUOROSCOPIC EQUIPMENT
 

A. Particular care should be taken to limit the useful beam to the smallest area consistent with clinical requirements and to align accurately the X-ray beam with the patient and film.
 

B. Gonadal shielding should be used for the patient when appropriate, but never as a substitute for adequate beam collimation and alignment.
 

C. When a patient must be held in position for radiography, mechanical supporting or restraining devices should be used. If the patient must be held by an individual, that individual shall be protected with appropriate shielding devices, such as protective lean gloves and an apron. The individual should be so positioned that no part of his body will be struck by the useful beam and that his body is as far as possible from the edge of the useful beam.
 

D. Special precautions, consistent with clinical needs, should be taken to minimize exposures of the embry or fetus in patients known to be or suspected of being pregnant.
 

E. Use the maximum source-skin distance consistent with the conditions of the examination.
 

F. Stand as far as possible from the patient, the tube and the useful beam.. Wear a protective apron or stand behind a suitable shield of at least 0.5 mm lead equivalent.
 

XXV. SAFETY RULES: PERSONS IN THE VICINITY OF MOBILE X-RAY EQUIPMENT
 

A. Vacate the room if possible.
 

B. If in the room, stand as far as possible from the patient, the X-ray tube and the useful beam.
 

C. Declared pregnant women shall not hold patients.
 

D. Follow all instructions given by the X-ray technologist.
 

C. When a patient must be held in position for radiography, mechanical supporting or restraining devices should be used. If the patient must be held by an individual, that individual shall be protected with appropriate shielding devices, such as protective lead gloves and an apron. The individual should be so positioned that no part of his body will be struck by the useful beam and that his body is as far as possible from the edge of the useful beam.
 

XXVI. SPECIFIC INSTRUCTIONS FOR ALLIED MEDICAL WORKERS
 

Housekeeping Personnel:
 

All housekeeping personnel should be aware of the locations of all restricted area in order to practice good radiation protection measures.
 

The measures are:
 

1) Get user permission and instructions from the RSO before cleaning any spill in restricted area.
 

2) Do not clean counter tops, hoods, refrigerators or sinks in restricted areas unless specifically requested and instructed by the area supervisor or RSO.
 

3) Do not remove bedclothes, dishes, trash or other items from rooms posted with radiation signs unless specifically instructed by a member of the radiation safety staff.
 

Security Personnel:
 

All security personnel should be aware of the locations of all restricted areas and be able to recognize packages containing radioaactive material in order to practice good radiation protection measures.
 

Maintenance Personnel:
 

All maintenance personnel should be aware of the locations of all restricted areas so that they may practice good radiation protection measures.
 

These measures are:
 

1) Obtain permission before working in an area that is in or adjacent to a restricted area.
 

2) Be aware of hoods, sinks, refrigerators and storage areas used for radioactive materials or sources.
 

Clerical Personnel:
 

All clerical personnel in the departments that use radiation should be aware of the locations of restricted areas so that they may practice good radiation protection measures.
 

Good practice includes:
 

1) Do not eat, drink, smoke or apply cosmetics in areas where radioactive materials are used.
 

2) Do not store food or drink in refrigerators where radioactive materials are stored.
 

XXVII. RADIATION AND PREGNANCY, RADIATION AND ALLIED MEDICAL STAFF
 

Radiation and allied medical staff who may be exposed to radiation should contact the RSO if they become pregnant or are planning to become pregnant. The mother assumes all risk until she specifically declares her pregnancy in a written and signed statement to her supervisor or the RSO. At that time, the hospital is responsible for assuring that the duties of a female staff member will not result in a dose equivalent that is more than 500 mrem to the fetus.
 

THE MOST RADIOSENSITIVE PERIOD FOR THE EMBRYO/FETUS IS FROM EIGHT TO FIFTEEN (8-15) WEEKS GESTATION ARE.
 

Guidelines for protecting the embryo/fetus are: (Observe Checked Items)
 

1. Distance protection shall be practiced at all times.
 

2. At no time shall any part of the body be so positioned that allows exposure from the primary beam from X-ray sources or unshielded radioactive sources.
 

3. Holding patients for immobilization shall be prohibited.
 

4. Mobile X-ray or Fluoroscopy work must be performed with protection of a 0.5 mm lead equivalent wrap-around apron.
 

5. The personal monitoring device (film badge) shall be worn at the lapel outside of the protective apron.
 

6. An additional monitoring device shall be worn at waist level under the protective apron (when apron is worn) to determine exposure directly to the fetus.
 

7. Impermeable disposable gloves shall be worn and pipetting device used while performing manipulations involving radionuclides.
 

8. Generator elution shall not be performed during the first trimester.
 

9. Kit preparation shall not be performed during the first trimester.
 
 
 

10. Therapeutic amounts of radionuclides shall not be administered.
 

11. Ventilation imaging shall not be performed.
 

12. Millicurie amounts of ³H, ¹⁴C, ¹²⁵I, or ¹³¹I shall not be used.
 

13. Extra care shall be observed to avoid spillage, vaporization and internal/external contamination.
 

I SHALL OBSERVE ITEMS CHECKED ABOVE.
 

EMPLOYEE DATE
 

RSO
 

XXVIII. DIAGNOSTIC RADIOLOGY AND THE PREGNANT PATIENT
 

The possibility of pregnancy must be taken into account by the attending physician when he/she is deciding on examinations that involve the lower abdomen and pelvis of women of reproductive capacity. The ten (10) day interval following the onset of menstruation is the time when it is most improbable that such women could be pregnant. Therefore, it is recommended that all lower abdomen and pelvic radiological examinations of women of reproductive capacity which are not of importance in connection with the immediate illness of the patient be limited to this period when pregnancy is improbable. The examination that will be appropriate to delay until the onset of the next menstruation are the few that could without detriment be postponed until the conclusion of a pregnancy, or at least until its later half.
 

Representative X-Ray Procedures

Grouped According to Degree of Embryo/Fetal Hazard

High Dose Lumbar Spine

Pelvis and Abdomen

Hip and Femur

Urography

Pyelography

Urethrocystography

Barium Enema
 
 
 

Moderate Dose Stomach

Upper Gastrointestinal Tract

Cholecystography

Cholangiography

Chest, Fluoroscopy
 
 
 

Low Dose Skull

Cervical Spine

Dorsal Spine

Extremities

Chest, Radiography

Dental
 
 
 

XXIX. PATIENT PREGNANCY SCREENING
 

Purpose: To assure that all precautions are taken to prevent the exposure of a pregnant female.
 

Policy: All females in the childbearing years shall pass a pregnancy screen prior to examination.
 

Procedures: All females in childbearing years will be questioned as to the possibility of pregnancy prior to initiation of a Radiographic/Fluoroscopic and/or Nuclear Medicine Study.
 

In the event the patient has a possibility of pregnancy, the attending physician must be notified for approval prior to the exam.
 

A verbal order for the performance of a pregnancy test shall be obtained and the examination postponed pending results.
 

Pregnancy Screen Questionaire
 

In order to perform the procedures which have been ordered by your physician, please help us by answering the following:
 

FIRST DAY OF LAST MENSTRUAL PERIOD:

Following is a list of questions for a patient over the age of twelve (12) and under the age of 50:
 

1. Do you take birth control pills?
 

2. Have you had a hysterectomy?
 

3. Have you had a tubal ligation?
 

4. Are you post-menopausal?
 

5. Are you in the first ten (10) days of your cycle?
 

Verify that you have questioned the patient regarding the possibility of pregnancy in the Radiology Information System or other permanent patient record. This will serve as documentation that you have addressed this issue with the patient.
 

XXX. NUCLEAR MEDICINE AND THE PREGNANT PATIENT
 

The patient who is or thinks she might be pregnant, or who is nursing, should be encouraged to give this information to her attending physician when the examination history is taken.
 

The nursing woman should suspend breast feeding for an appropriate period of time following a nuclear medicine examination. The nuclear medicine physician or certified radiological physicist can advise the nursing woman on the length of time that nursing should be suspended.
 

The attending physician can use nuclear medicine consultation request forms in non-emergency situations to record the pregnancy and nursing status of a woman of childbearing age. In addition, the attending physician should encourage the patient to provide this information. If there is a medical emergency, if the nuclear medicine examination will contribute vital information to the diagnosis and if there are no alternative methods for obtaining this information that would result in lower radiation exposure, the examination generally should be performed regardless of the patient's pregnancy state. Attention must be pain to technical modifications of the procedure that will minimize radiation exposure.
 

The nuclear medicine technologist, in the absence of information about the patient's pregnancy or nursing status, should be encouraged to ask the patient if she is or may be pregnant or if she is nursing. If the patient replies that she is or may be pregnant or is nursing, the technologist must notify the physician in charge at once.
 

The nuclear medicine physician should be aware of appropriate alternatives prior to conducting a nuclear medicine procedure on a pregnant or potentially pregnant woman or one who is nursing. The nuclear medicine physician should be prepared to consult with the attending physician on possible alternatives which include:
 

A. Requesting the use of a radionuclide that delivers a lower radiation dose or one that is less likely to cross the placental barriers than the radionuclide usually used, if the diagnostic objectives can still be met.
 

B. In the case of a known pregnancy, assessing the possibility of deferring the examination until pregnancy is concluded.
 

C. In the case of a possible but unconfirmed pregnancy, deferring the examination that is not immediately needed until the pregnancy is ruled out.
 

D. Canceling the nonemergency examination once aware that the patient is or may be pregnant.
 

E. Directing the nursing woman to suspend breast feeding for the period of time that radioactivity is present in the milk.
 

F. Ascertaining the advisability of using other clinical modalities to diagnose the patient's condition.

XXXI. QUALITY CONTROL PROCEDURES
 

A. Calibration of dose Calibrator
 

Test for the following at the indicated frequency. Consider repair, replacement or arithmetic correction if the dose calibrator falls outside the suggested tolerances. (These recommended tolerances are more restrict than those in the regulations to ensure that corrective action will be taken before the dose calibrator is outside permissible tolerances).
 

a. Constancy at least once each day prior to assay of patient dosages (±5%).
 

b. Linearity at installation and quarterly thereafter (±5%).
 

c. Geometry variation at installation (±5%).
 

d. Accuracy at installation and at least annually thereafter (±5%).
 

After repair, adjustment or relocation of the dose calibrator, repeat above test as required.
 

Constancy means reproducibility in measuring a constant source over a longer period of time. Assay at least one relatively long-lived source (¹³⁷Cs, ⁶⁰Co, ⁵⁷Co or ²²⁶Ra) using a reproducible geometry each day before using the calibrator. Consider the use of two (2) or more sources with different photon energies and activities. Use the following procedure:
 

a. Assay each reference source using the appropriate dose calibrator setting (use the ¹³⁷Cs setting to assay ¹³⁷Cs).
 

b. Measure bkg at the same setting and subtract or confirm the proper operation of the automatic bkg. Subtract circuit if it is used.
 

c. For each source used, either plot on graph paper or log in a book the bkg level for each setting checked and the net activity of each constancy source.
 

d. Using one of the sources used, repeat the above procedure for all commonly used radioisotope settings. Plot or log the results.
 

e. Establish an action level or tolerance for each recorded measurement at which the individual performing the test will automatically notify the chief technologist or authorized user of suspected malfunction of the calibrator.
 

Inspect the instrument on a quarterly basis to ascertain that the measurement chamber liner is in place and that the instrument is zeroed according to the manufacturer's instructions.
 

Linearity means that the calibrator is able to indicate the correct activity over the range of use of that calibrator. This test is done using a vial or syringe of ^99mTc whose activity is at least as large as the maximum activity normally assayed in a prepared radiopharmaceutical kit, in a unit dosage syringe or in a radiopharmaceutical therapy, whichever is largest.

Decay Method
 

a. Assay the ^99mTc syringe or vial in the dose calibrator, and subtract background to obtain the net activity in mCi. Record the date, time to the nearest minute and net activity on the Dose Calibrator Linearity Test Form. This first assay should be done in the morning at a regular time, for example, 8 a.m.
 

b. Repeat the assay at noon and again at 4 p.m. Continue on subsequent days until the assayed activity is less than 10 µCi. For dose calibrators on which one selects a range with a switch, select the range you would normally utilize for the measurement.
 

c. Convert the time and date information one recorded to hours elapsed since the first assay.
 

d. On a sheet of semilog graph paper, label the logarithmic vertical axis in mCi and label the linear horizontal axis in hours elapsed. At the top of the graph, note the date and the manufacturer, model number and serial number of the dose calibrator. Plot the data.
 

e. Draw a "best fit" straight line through the data points. For the point farthest from the line, calculate its deviation from the value on the line (A-observed - A-line)/(A-line) = deviation.
 

f. If the worst deviation is more than ±0.05, the dose calibrator should be repaired or adjusted. If this cannot be done, it will be necessary to make a correction table or graph that will allow you to convert from activity indicated by the dose calibrator to "true activity."
 

g. Put a sticker on the dose calibrator indicating when the next linearity test is due.
 

Shield Method
 

If you decide to use a set of "sleeves" of various thicknesses to test for linearity, it will first be necessary to calibrate them.
 

a. Begin the linearity test as described in the decay method above. After making the first assay, the sleeves can be calibrated as follows. Steps b through d below must be completed in six (6) minutes.
 

b. Put the base and sleeve one (1) in the dose calibrator with the vial. Record the sleeve number and indicated activity.
 

c. Remove sleeve one (1) and put in sleeve two (2). Record the sleeve number and indicated activity.
 

d. Continue for all sleeves.
 

e. Complete the decay method linearity test steps b through g above.
 

f. From the graph made in step d of the decay method, find the decay time associated with the activity indicated with sleeve one (1) in place. This is the "equivalent decay time" for sleeve one (1). Record that time with the data recorded in step b.
 

g. Find the decay time associated with the activity indicated with sleeve two (2) in place. This is the "equivalent decay time" for sleeve two (2). Record that time with the data recorded in step c.
 

h. Continue for all sleeves.
 

i. The table of sleeve numbers and equivalent decay time constitutes the calibration of the sleeve set.
 

The sleeve set may now be used to test linearity of the dose calibrator.
 

a. Assay the ^99mTc syringe or vial in the dose calibrator and subtract bkg to obtain net activity in mCi. Record the net activity.
 

b. Steps c through e below must be completed within six (6) minutes.
 

c. Put the base and sleeve one (1) in the dose calibrator with the vial. Record the sleeve number and indicated activity.
 

d. Remove sleeve one (1) and insert sleeve two (2). Record the sleeve number and indicated activity.
 

e. Continue for all sleeves.
 

f. On a sheet of semilog graph, label the logarithmic vertical axis in mCi and label the linear horizontal axis in hours elapsed. At the top of the graph, note the date, manufacturer, model number and serial number of the dose calibrator.
 

g. Plot the data using the equivalent decay time associated with each sleeve.
 

h. Draw a "best fit" straight line through the data points. For the point farthest from the line, calculate its deviation from the value on the line (A-observed - A-line)/(A-line) = deviation.
 

i. If the worst deviation is more than ±0.05, the dose calibrator should be repaired or adjusted. If this cannot be done, it will be necessary to make a correction table or graph that will allow you to convert from activity indicated by the dose calibrator to "true activity".
 

j. Put a sticker on the dose calibrator indicating when the next linearity test is due.
 

Geometric Variation means that the indicated activity does not change with volume or configuration. This test should be done using a syringe that is normally used for injections. Licensees who use generators and radiopharmaceuticals kits should also do the test using a vial similar in size, shape and construction to the radiopharmaceutical kit vials normally used. The following test assumes injections are performed with 3-cc plastic syringes and that radiopharmaceutical kits are made in 30-cc glass vials. If you do not use these, change the procedure so that your syringes and vials are tested throughout the range of volumes commonly used.
 

a. In a small beaker or vial, mix 2 cc of a solution of ^99mTc with an activity concentration between one (1) and ten (10) mCi/ml. Set out a second small beaker or vial with tap water or nonradioactive saline.
 

b. Draw 0.5 cc of the ^99mTc solution into the syringe and assay it. Record the volume and mCi indicated on a Dose Calibrator Geometric Variation and Accuracy Form.
 

c. Remove the syringe form the calibrator, draw an additional 0.5 cc of tap water or nonradioactive saline and assay again. Record the volume and mCi indicated.
 

d. Repeat the process until one has assayed a 2.0-cc volume.
 

e. Select as a standard the volume closest to that normally used for injections. For all the other volumes, divide the standard mCi by the mCi indicated for each volume. The quotient is a volume correction factor. Alternatively, you may graph the data and draw horizontal five percent (5%) error lines above and below the chosen "standard volume."
 

f. If any correction factors are greater than 1.05 or less than 0.95, or if any data points lie outside the five percent (5%) error lines, it will be necessary to make a correction table that will allow one to convert from "indicated activity" to "true activity." If this is required, be sure to label the table or graph "syringe geometric variation dependence" and note the date, model number and serial number of the dose calibrator.
 

g. To test the geometry dependence for 30-cc glass vial draw 1.0-cc of the ^99mTc into a syringe and inject it into the vial. Assay the vial. Record the volume and mCi indicated.
 

h. Remove the vial from the calibrator. Using a clean syringe, inject 2.0-cc of tap water or nonradioactive saline into the vial and assay. Record the volume and mCi indicated.
 

i. Repeat the process until you have assayed a 19.0-cc volume. The entire process must be completed within ten (10) minutes.
 

j. Select as a standard the volume closest to that normally used for mixing radiopharmaceutical kits. For all the other volumes, divide the standard mCi by the mCi indicated for each volume. The quotient is a volume correction factor. Alternatively, you may graph the data and draw horizonal five percent (5%) error lines above and below the chosen "standard volume."
 

k. If any correction factors are greater than 1.05 or less than 0.95, or if any data points lie outside the five percent (5%) error lines, it will be necessary to make a correction table that will allow one to convert from "indicated activity" to "true activity." If this is required, be sure to label the table or graph "vial geometric variation dependence" and note the date, model number and serial number of the the calibrator.
 

Accuracy, for a given calibrated reference source, means the indicated mCi value is equal to the mCi value determined by the National Institute of Standards and Technology (NIST) or by the supplier who has compared that source to a source that was calibrated by the NIST. Certified sources are available from the NIST and from radioisotope suppliers. At least two (2) sources with different principal photon energies (⁵⁷Co, ⁶⁰Co or ¹³⁷Cs) should be used. The regulations require that one source must have a principal photon energy between 100 keV and 500 keV. The regulations also require that if ²²⁶Ra is used, it must be at least ten (10) µCi; other sources must be at least 50 µCi. Consider using at least one (1) reference source whose activity is within the range of activities normally assayed.
 

a. Assay a calibrated reference source at the appropriate setting (i.e., use the ⁵⁷Co setting to assay ⁵⁷Co) and remove the source and measure bkg. Subtract bkg from the indicated activity to obtain net activity. Record this measurement on a Dose Calibrator Geometry and Accuracy Form. Repeat for a total of three (3) determinations.
 

b. Average the three (3) determinations. The average value should be within five percent (5%) percent of the certified activity of the reference source, mathematically corrected for decay.
 

c. Repeat the procedure for other calibrated reference sources.
 

d. If the average value does not agree within five percent (5%) of the certified value of the reference source, the dose calibrator may require repair or replacement. Regulations requires repair or replacement if the error exceeds ten percent (10%).
 

e. At the same time the accuracy test is performed, assay the source that will be used for the daily constancy test (it need not be certified reference source) on all commonly used radioisotope settings. Record the settings and indicated mCi values with the accuracy data.
 

f. Put a sticker on the dose indicating when the next accuracy test is due.
 

The RSO will review and sign the records of all geometric variation, linearity and accuracy tests.
 

B. Quality Control, Scintillation Camera
 

1. Total System Uniformity (Daily)
 

(a) Materials
 

(1) Flood phantom: fill with water and add 1 to 5 (1-5) mCi of ^99mTc, count rate should be less than 20,000 cps, or ⁵⁷Co flood source, or ^99mTc point source of 100 to 200 µCi; count rate of no greater than 20,000 cps.
 

(2) Collimator; low energy, parallel hole.
 

(b) Procedure
 

(1) Place collimator on detector and invert detector head.
 

(2) Place ⁵⁷Co flood source or ^99mTc flood phantom on collimator. If flood phantom is used, protect against contamination by interposing plastic-backed absorbent paper between the phantom and the detector.
 

(3) Set and visually verify appropriate pulse height analyzer setting with a 20% window.
 

(4) Set appropriate intensity.
 

(5) Collect one million uncorrected counts if a camera with a standard field of view is used; collect two million uncorrected counts for a camera with a large field of view.
 

(c) Data Treatment
 

(1) Visually inspect film for nonuniformities.
 

2. System Spatial Resolution (Weekly)
 

(a) Materials
 

(1) Flood phantom: fill with water and add 1 to 5 (1-5)mCi of ^99mTc; count rate should be less than 20,000 cps, or ⁵⁷Co flood source, or ^99mTc point source of 100 to 200 µCi; count rate of no greater than 20,000 cps.
 

(2) Collimator; low energy, parallel hole.
 

(3) Bar phantom.
 

(b) Procedure
 

(1) Attach low-energy parallel-hole collimator and invert detector.
 

(2) Arrange bar phantom and ^99mTc flood source on face of detector.
 

(3) Set and visually verify appropriate PHA setting using a 20% window.
 

(4) Set appropriate intensity.
 

(5) Collect one million uncorrected counts if a camera with a standard field of view is used; collect two million uncorrected counts for a camera with a large field of view.
 

(c) Data Treatment
 

(1) Visually inspect films for degree of resolution.
 

(2) Are bars straight? Did collimation correct "barreling" or wavy lines noted in intrinsic resolution studies (if available)?
 

3. System Sensitivity (Annually)
 

(a) Materials
 

(1) Approximately 100 to 200 µCi ^99mTc point source, count rate should be 10,000 cps.
 

(2) Low-energy parallel-hole collimator only, since diverging or converging collimators are too sensitive to the source-detection distance.
 

(b) Procedure
 

(1) Place collimator on detector and raise to five (5) UFOV diameters. Draw line on detector column for reproducibility.
 

(2) Place point source on floor.
 

(3) Set and visually verify appropriate pulse height analyzer setting with a 20% window.
 

(4) Collect three (3) one (1) minute counts.
 

(c) Data Treatment
 

(1) Determine mean counts per minute.
 

(2) Remove source and count bkg.
 

(3) Express sensitivity as net counts per minute per µCi.
 

SENSITIVITY
 
 
 

FACILITY:
 

CAMERA: COLLIMATOR
 

POINT SOURCE ACTIVITY: µCi
 

CAMERA ORIENTATION:
 

DISTANCE FROM POINT SOURCE TO COLLIMATOR SURFACE:
 

COUNT PERIOD GROSS CPM BKG CPM
 

1
 

2
 

3
 

AVERAGE
 

AVERAGE GROSS CPM - AVERAGE BKG CPM = NET CPM
 

SENSITIVITY = NET CPM

µCi
 
 
 

PERFORMED BY: DATE:
 

D. Quality Control of "In-House" Prepared Radiopharmaceuticals
 

(1) ⁹⁹Mo-^99mTc Generators
 

(a) Molybdenum breakthrough shall be performed on all generator eluents before administration to patients. Permissible limits: 0.07 µCi of ⁹⁹Mo per mCi of ^99mTc not to exceed 2.5 µCi of ⁹⁹Mo per dose.
 

(b) Aluminum breakthrough shall be performed on all generator eluents before administration to patients. Permissible limits: 10 µg of aluminum per ml of eluent.
 

(2) Chromatography
 

(a) Chromatography shall be employed for radiochemical impurities. Determination of percentage ^99mTc tagged or labeled shall be performed on all "kit" prepared radionuclides. Permissible limits: greater than 90% ^99mTc bound.
 

(3) Radiopharmaceuticals for clinical procedures shall comply with the product label or package insert regarding physical form, route of administration and dosage range.
 

E. Sealed Sources; Leakage/Contamination
 

Each sealed source, other than ³H, with a half-life greater than thirty days and in any form other than gas, shall be tested for leakage/contamination prior to initial use and at intervals not to exceed six (6) months. Notwithstanding the periodic leak test required, any sealed source is exempt from such leak tests when the source contains 100 µCi or less of beta and/or gamma emitting material or 10 µCi or less of alpha emitting material. If at any time, there is reason to suspect that a sealed source may have been damaged or may be leaking, the source shall be tested for leakage before further use. In the absence of a certificate from a transferor indicating that a leak test has been made within six (6) months prior to the transfer, the sealed source shall not be put into use until tested.
 

F. Procedures for Calibration of Survey Instruments
 

(a) The source must be approximately a point source.
 

(b) Either the apparent source activity or the exposure rate at a given distance must be traceable by documented measurements to a standard certified within 5 percent (5%) accuracy by the NIST.
 

(c) A source that has approximately the same photon energy as the environment in which the calibrated device will be employed should be used for the calibration.
 

(d) The source should be sufficient strength to give an exposure rate of about 30 mR/hr at 100 cm. Minimum activities of typical sources are 85 mCi of ¹³⁷Cs or 21 mCi of ⁶⁰Co.
 

(e) The inverse square law and the radioactive decay law must be used to correct for change in exposure rate due to changes in distance or source decay.
 

(f) A record must be made of each survey meter calibration.
 

(g) A single point on a survey meter scale may be considered satisfactorily calibrated if the indicated exposure rate differs from the calculated exposure rate by less than 10 percent (10%).
 

Three kinds of scales are frequently used on survey meters:
 

(a) Meters on which the user selects a linear scale must be calibrated at no less than two (2) points on each scale. The points should be at approximately 1/3 and 2/3 of full scale.
 

(b) Meters that have a multidecade logarithmic scale must be calibrated at no less than one (1) point on each decade and no less than two (2) points on one (1) of the decades. Those points should be at approximately 1/3 and 2/3 of the decade.
 

(c) Meters that have an automatically ranging digital display device for indicating rates must be calibrated at no less than one (1) point on each decade and at no less than two (2) points on one (1) of the decades. Those points should be approximately 1/3 and 2/3 of the decade.
 

Readings above 1,000 mR/hr need not be calibrated. However, such scales should be checked for operation and approximately correct response.
 

At the time of calibration, the apparent exposure rate from a built-in or owner-supplied check source must be determined and recorded.
 

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 instrument
 

(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, the indicated 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 G-M or ionization-type detectors, this will usually be "parallel" or "perpendicular" indicating photons traveling either parallel with or perpendicular to the central axis of the detector; for instruments with internal detectors, this should be the angle between the flux field and a specified surface of the instrument)
 

(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 rate from the check source
 

(i) The name of the person who performed the calibration, the date on which the calibration was performed and the next calibration date.
 

XXXII. PROCEDURES FOR NURSING STAFF AND PATIENT CARE
 

A. Diagnostic Procedures
 

Since there is minimal external hazard to others from routine diagnostic doses of radionuclides, there are no restrictions on the patient's activities or his/her contacts with other people. Nursing personnel are not required to wear personnel monitoring devices.
 

The following procedures apply when a patient receives radioactive material for diagnostic purposes:
 

1. Questions concerning the use of radionuclides for diagnostic nuclear medicine procedures should be presented to Nuclear Medicine.
 

2. If radioactive contamination is suspected, nursing personnel should use impermeable disposable gloves to handle items and contact Nuclear Medicine. Particular care should be exercised for handling vomitus during the first 24 hours following administration of a radionuclide.
 

3. Special diagnostic procedures will be evaluated on an individual basis and appropriate written instructions may be issued.
 

B. Therapeutic Procedures
 

1. Patients Receiving Brachytherapy Sources
 

(a) Sealed source therapy will be offered by approved Radiation Therapy Consultants. The RSC will advise Administration of those radiation therapists that are approved for use of sealed source therapy.
 

(b) The RSC will use in part the following criteria for evaluation of radiation therapists:
 

1) All rules and regulations of the Medical Staff relative to record keeping are observed.
 

2) Written verification of leak test of sealed sources must be maintained at six (6) month intervals.
 

3) Sealed sources that are transported to the Hospital shall be transferred in containers which will limit the radiation level at one meter (1m) from the center of the container to 2 mR/hr or less.
 

4) At least 48 hours notification shall be provided to Nuclear Medicine so that appropriate preparation and precautionary measures may be initiated. Notification shall include:
 

a) The number, loading and type of sealed source to be transferred
 

b) The name and location of the patient to which the material will be transferred
 

c) The time of source insertion and removal.
 

d) At least 48 hours notification shall also be provided to the Operating Room Supervisor and Head Nurse for sources to be inserted in Surgery.
 

(c) The RSO shall be responsible for:
 

a) Maintaining a log book in Nuclear Medicine to indicate the number, loading and type of sealed source that has been transferred as well as the location (name of patient), time of source insertion and removal
 

b) Completing the "Radioactivity Precaution Tag" to be attached to the door of the patient's room and attaching the "Caution, Radioactive Materials" label to the cover of the patient's chart
 

c) Surveying the patient's room and surrounding areas as soon as practical after administration of the radionuclide and at conclusion of treatment and completing the "Radionuclide Therapy Survey" form.
 

2. Patients receiving radionuclide therapy as solution, colloid or microsphere
 

a) Prior to therapy, the form "Therapeutic Radionuclide Consultation Form" is to be completed and becomes a part of the patient's chart.
 

b) The RSO shall be responsible for:
 

1) Assuring that the responsible physician has completed the appropriate form in Appendix X to become a part of the patient's chart.
 

2) Completing the "Radioactivity Precautions Tag" to be attached to the foot of the patient's bed or to door of room and attaching the "Caution, Radioactive Materials" label to the cover of the patient's chart.
 

3) Surveying the patient's room and surrounding areas as soon as practical after administration of the radionuclide and at discharge of the patient. In addition, the RSO shall completing the form "Radionuclide Therapy Survey."
 

3. Patients requiring emergency surgery after therapy
 

a) Consultation shall be made with the Nuclear Physician who shall notify the RSO.
 

4. Death of patient after therapy
 

a) Consultation shall be made with the Nuclear Physician who shall notify the RSO.
 

XXXIII. TRAINING PROGRAM: PERSONNEL WORKING IN THE VICINITY OF RADIOACTIVE MATERIAL/OPERATORS OF X-RAY SYSTEMS
 

A. Personnel to be included in Training
 

1. Nuclear Medicine Technologists.
 

2. Any Ancillary Personnel whose duties may require them to work in the vicinity of radioactive material (including housekeeping, security, clerical staff etc.).
 

3. X-Ray Technologists.
 

B. Frequency of Training
 

Personnel will be instructed:
 

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

2. During an annual refresher course.
 

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

C. Topics of Instruction
 

Subjects which will be included in all training sessions will include:
 

1. Applicable regulations and license conditions.
 

2. Identification of areas where radioactive material is used or stored.
 

3. Potential hazards associated with radioactive material in each area where the employees will work.
 

4. Safe operating procedures; safe use of equipment.
 

5. Appropriate radiation safety procedures.
 

6. In-house work rules.
 

7. Each individual's obligation to report unsafe conditions to the RSO.
 

8. Appropriate response to emergencies or unsafe conditions.
 

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

10. Locations where the licensee has posted or made available notices, copies of pertinent regulations and copies of pertinent licenses and license conditions (including applications and applicable correspondence) as required by Louisiana Environmental Regulatory Code.
 

11. Questions and answer period.

XXXIV. PROCEDURE FOR MONITORING OR CHECKING TRAP EFFLUENT
 

Charcoal traps can significantly reduce air contamination. They can also become saturated or be spoiled by improper use, humidity, chemicals or inadequate maintenance.
 

1. If the trap effluent is monitored by a radiation detector designed to monitor effluent gas, check the detector according to the manufacturer's instructions. Keepa record of the checks.
 

2. If you do not monitor the trap effluent, check it on receipt and once each month. Collect the effluent from the trap during one patient study in a plastic bag and monitor the activity in the bag by holding the bag against a camera, with the camera adjusted to detect noble gas. Compare the bag's cpm to bkg cpm with no other radioactivity in the area. Keep a record of the date, bkg cpm, and bag cpm.
 

3. The RSO will establish an action level based on cpm or a multiple of bkg cpm. If you measure a significant increase in the bag cpm, the trap is breaking down and must be replaced.
 

4. Follow the trap manufacturer's instructions for replacing the trap.

RADIATION SAFETY COMMITTEE

George R. Meckstroth, Ph.D., Chairman 584-2978
 

Charles F. Reindl, M.S., RSO 584-2867
 

James J. Balsamo, Jr., MPH 588-5486
 

William Alworth, Ph.D. 865-5573
 

Richard Campeau, M.D. 587-7567
 

Jean L. Heneghan, M.S. 588-5259
 

Gillian Knowles, R.N. 584-2885
 

Dennis McNamara, Ph.D. 588-5444
 

Luis A. Ortiz, M.D. 588-2250
 

William R. Robertson III, M.D. 588-5217
 

Rodney L. Sparks, Ph.D. 588-5255
 

APPENDIX B

TECHNOLOGISTS APPROVED FOR RADIONUCLIDE INJECTIONS

Verna Toups, R.T.

Chief Technologist

Section of Nuclear Medicine
 

Debra McArthur, R.T.

Section of Nuclear Medicine
 

Robin Thompson, (ART)

Section of Nuclear Medicine
 

Stanley Fabregast, R.T., N.M.T.

Section of Nuclear Medicine
 

Marvelle Baudy, C.N.T.

Section of Pathology
 

APPENDIX C

DAILY INCOMING/OUTGOING SURVEY INSTRUMENT:

SHIPMENT INSPECTION LOG
 
 
 

ACTION LEVELS:

10 mR/hr at three feet CONVERSION FACTOR:

200 mR/hr at surface

Wipe test of 2,220 dpm or 0.001 µCi
 
 
 

IF ANY ACTION LEVEL IS EXCEEDED, STOP AND NOTIFY THE

RADIATION SAFETY OFFICER
 

RADIONUCLIDE DISTRIBUTION

 
 

DOSE CALIBRATOR CALIBRATION RECORD

Reference Standard Month Year
 

⁵⁷Co ¹³³Ba ¹³⁷Cs
 

Activity:

on
 

Date:
 

Serial No.:
 

Calculated Measured

Reference Std. Reference Std.

Activity Activity
 
 
 

APPENDIX F

RADIONUCLIDE DECAY-IN-STORAGE/DISPOSAL FORM

APPENDIX G
 

INSTRUMENT MAINTENANCE & REPAIR RECORD
 

Instrument Make: Model No.: Serial No.:
 

Date:
 

Reason for Request of Service or Malfunction:
 

Service Requested on:
 

By (Technician):
 

To (Source of service): Service completed on:
 

By (Source of Service):
 

Service Report Indicating Repain Performed:
 

Amount:
 

Purchase Requisition Number:
 

APPENDIX H
 

RADIATION HISTORY REQUEST FORM
 
 
 

DATE:
 
 
 
 

In order to complete the radiation history on the individual indicated below, a record of their radiation exposure is required.
 

PERSONAL DATA
 

NAME
 

DATE OF BIRTH
 

SOCIAL SECURITY NO.
 

EMPLOYED DATES
 

DEPARTMENT
 

MONITORING PERIOD
 

TOTAL ACCUMULATED DOSE DEEP (mRem) SHALLOW (mRem)
 

RESULTS OF BIOASSAYS/THYROID MONITORING, IF PERFORMED
 

RADIONUCLIDE CRITICAL ORGAN TOTAL BODY ESTIMATED BIOASSAY

BURDEN (mRem) EXPOSURE DATE

(mRem)
 
 
 
 
 
 

Thank you for your assistance.
 

Very truly yours,
 
 
 
 
 

Radiation Safety Officer
 

APPENDIX I
 

FILM BADGE MONITORING SERVICE REQUEST
 

Radiation Regulations require your past radiation exposure. Please complete this form, sign and return to the Radiation Safety Officer.
 

FULL LEGAL NAME

Last First Middle
 

SOCIAL SECURITY NO.
 

PREVIOUS EMPLOYMENT(S) INVOLVING RADIATION EXPOSURE:
 

NEVER MONITORED:
 

PREVIOUSLY MONITORED LOCATIONS:
 

EMPLOYER
 

DEPARTMENT
 

MAILING ADDRESS
 
 
 
 

DATE OF EMPLOYMENT TO

USE BACK OF SHEET IF MORE THAN ONE EMPLOYER.
 
 
 

I HEREBY AUTHORIZE THE RELEASE OF MY RADIATION EXPOSURE HISTORY TO
 
 
 

SIGNATURE
 

TITLE
 

DEPARTMENT DATE
 
 
 

APPENDIX J
 

NOTICE TO EMPLOIYEES
 

APPENDIX K
 

EFFECTIVE DOSE EQUIVALENT LIMIT RECOMMENDATIONS^A
 
 
 

A. Occupational exposures (annual)^b
 

1. Effective dose equivalent limit

(stochastic effects) 50 mSv (5 rem)
 

2. Dose equivalent limits for

tissues and organs (nonstochastic

effects)
 

a. Lens of eye 150 mSv (15 rem)
 

b. all others (e.g. red bone

marrow, breast, lung, skin

and extremities) 500 mSv (50 rem)
 

3. Guidance: Cumulative exposure 10 mSv x age (1 rem x age

in years)
 

B. Public exposures (annual)
 

1. Effective dose equivalent limit,

continuous or frequent exposure^b 1 mSv (0.1 rem)
 

2. Effective dose equivalent limit,

infrequent exposure^b 5 mSv (0.5 rem)
 

3. Remedial action recommended when

effective dose^c >5 mSv (>0.5 rem)
 

4. Dose equivalent for lens of

eye, skin and extremities^b 50 mSv (5 rem)
 

C. Embryo-Fetus Exposures^b
 

1. Total dose equivalent limit 5 mSv (0.5 rem)
 

2. Dose equivalent in a month 0.5 mSv (0.05 rem)
 

D. Education and training exposures (annual)^b
 

1. Effective dose equivalent limit 1 mSv (0.1 rem)
 

2. Dose equivalent limits for lens

of eye, skin and extremities 50 mSv (5 rem)
 

E. Negligible Individual Risk Level (annual)^b
 

1. Effective dose equivalent per source or

practice 0.01 mSv (0.001 rem)

^aExcluding medical exposures.

^bSum of external and internal exposures.

^cIncluding background but excluding internal exposures.
 

APPENDIX L
 

MODEL PROGRAMFOR MAINTAINING OCCUPATIONAL RADIATION EXPOSURES AT MEDICAL

INSTITUTIONS ALARA
 

ALARA PROGRAM
 

(Licensee's Name)
 

(Date)
 

1. Magagement Commitment
 

a. We, the management

are committed to the program described hereby for keeping individual and collective doses as low as is reasonably achievable (ALARA). In accord with this commitment, we hereby describe an administrative organization for radiation safety and will develop the necessary written policy, procedures and instructions to foster the ALARA concept within our institution. The organization will include a Radiation Safety Committee (RSC) and a Radiation Safety Officer (RSO).
 

b. We shall perform a formal annual review of the radiation safety program, including ALARA considerations. This will include reviews of operation procedures and past dose records, inspections, etc. and consultations with the radiation safety staff or outside consultants.
 

c. Modifications to operating and maintenance procedures and to equipment and facilities will be made if they will reduce exposures unless the cost, in our judgement, is considered to be unjustified. We shall be able to demonstrate, if necessary, that improvements have been sought, modifications have been considered and they have been implemented when reasonable. If modifications have been recommended but not implemented, we hsall be prepared to describe the reasons for not implementing them.
 

d. In addition to maintaining doses to individuals as far below the limits as is reasonably achievable, the sum of the doses received by all exposed individuals will also be maintained at the lowest 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 individuals.
 

2. Radiation Safety Committee
 

a. Review of Proposed Users and Uses
 

(1) The RSC will thoroughly review the qualifications of each applicant with respect to the types and quantities of materials and methods of use for which application has been made to ensure that the applicant will be able to take appropriate measures to maintain exposure to ALARA.
 

(2) When considering a new use of radioactive material, the RSC will review the efforts of the applicant to maintain exposure ALARA.

(3) The RSC will ensure that the users justify their procedures and that individual and collective doses will be ALARA.
 

b. Delegation of Authority
 

(The judicious delegation of RSC authority is essential to the enforcement of an ALARA program.)
 

(1) The RSC will delegate authority to the RSO for enforcement of the ALARA concept.
 

(2) The RSC will support the RSO when it is necessary for the RSO to assert authority. If the RSC has overruled the RSO, it will record the basis for its action in the minutes of the quarterly meeting.
 

c. Review of the ALARA Program
 

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

(2) The RSO will perform quarterly review of occupational radiation exposure with particular attention to instances in which the investigational levels in Tabel 1 are exceeded. The pricipal purpose of this review is to assess trends in occupational exposure as an index of the ALARA program quality and to decide if action is warranted when investigational levels qare exceeded (see Section 6 below for a discussion of investigational levels).
 

Table 1
 
 
 

Investigational Levels
 

Investigational Levels

(mRrems per calendar quarter)

Level I Level II
 

1. Whole body; head and trunk; active

blood-forming organs; lens of eyes;

or gonads 125 375
 

2. Hands and forearms; feet and ankles 375 1125
 

3. Skin of Whole Body* 1250 3750

*Not normally applicable to medical use operations except those using significant quantities of beta-emitting isotopes.
 
 
 
 

(3) The RSC will evaluate our institution's overall efforts for maintaining doses ALARA on an annual basis. This review will include the efforts of the RST, authorized users and workers as well as those of management.

3. Radiation Safety Officer
 

a. Annual and Quarterly Review
 

(1) Annual review of the radiation safety program. The RSO will perform an annual review of the radiation safety program for adherence to ALARA concepts. Reviews of specific methods of use may be conducted on a more frequent basis.;
 

(2) Quarterly review of occupationa exposures. The RSO will review at least quarterly the external radiation doses of authorized users and workers to determine that their doses are ALARA in accordance with the provisions of Section 6 of this program and will prepare a summary report for the RSC.
 

(3) Quarterly review of records of radiation surveys. The RSO will review radiation surveys in unrestricted and restricted areas to determine that dose rates and amounts of contamination were at ALARA levels during the previous quarter and will prepare a summary report for the RSC.
 

b. Education Responsibilities for ALARA Program
 

(1) The RSO will schedule briefings and educational sessions to inform workers of ALARA program efforts.
 

(2) The RSO will ensure that authorized users, workers and ancillary personnel who may be exposed to radiation will be instructed in the ALARA philosophy and informed that management, the RSC and the RSO are committed to implementing the ALARA concept.
 

c. Cooperative Efforts for Development of ALARA Procedures
 

Radiation workers will be given opportunities to participate in formulating the procedures that they will be required to follow.
 

(1) The RSO will be in close contact with all users and workers in order to develop ALARA procedures for working with radioactive materials.
 

(2) The RSO will establish procedurs for receiving and evaluating the suggestions of individual workers for improving health physics practices and will encourage the use of those prociedures.
 

d. Reviewing Instances of Deviation from Good ALARA Practices
 

The RSO will investigate all known instances of deviation from good ALARA practices, and, if possible, will determine the causes. When the cause is known, the RSO will implement changes in the program to maintain doses ALARA.
 

4. Authorized Users
 

a. New Methods of Use Involving Potential Radiation Doses
 

(1) The authorized user will consult with the RSO and/or RSC during the planning stage before using radioactive materials for new uses.

(2) The authorized user will review each planned use of radioactive materials to ensure that doses will be kept ALARA. Trial runs may be helpful.
 

b. Authorized User's Responsibility to Supervised Individuals
 

(1) The authorized user will explain the ALARA concept and the need to maintain exposures ALARA to all supervised individuals.
 

(2) The authorized user will ensure that supervised individuals who are subject to occupational radiation eposure are trained and educateed in good health physics practices and in maintaining exposures ALARA.
 

5. Individuals Who Receive Occupational Radiation Doses
 

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

b. Workers will be instructed in recourses available if they feel that ALARA is not being promoted on the job.
 

6. Establishment of Investigational Levels in Order to Monitor Individual Occupational External Radiation Dose
 

This institution hereby establishes investigational levels for occupational external radiation doses which, when exceeded, will initiate review or investigation by the RSC and/or RSO. The investigational levels that we have adopted are listed in Table 1. These levels apply to the exposure of individual workers.
 

The RSO will review and record of Form DRC-5, "Current Occupational External Radiation Exposure," or an equivalent form (e.g., dosimeter processor's report) results of personnel monitoring not less than once in any calendar quarter. The following actions will be taken at the investigational levels as stated in Table 1:
 

a. Personnel dose less than Investigational Level I.
 

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

b. Personnel dose equal to or greater than Investigation Level I but less than Investigational Levl II.
 

The RSO will review the dose of each individual whose quarterly dose equals or exceeds Investigational Level I and will report the results of the reviews at the first RSC meeting following the quarter when the dose whas recorded. If the dose does not equal or exceed Investigational Level II, no action related specifically to the exposure is required unless deemed appropriate by the Committee. The Committee will, however, review each such dose in comparison with those of others performing similar tasks as an index of ALARA program quality and will record the review in the Committee minutes.
 

c. Personnel dose equal to or greater than Investigational Level II.
 

The RSO will investigate in a timely manner the causes of all personnel doses equaling or exceeding Investigational Level II, and, if warrented, will take action. A report of the Investigation, any actions taken, and a copy of the individual's Form DRC-5, or its equivalent will be presented to the RSC at its first meeting following completion of the investigation. The details of these reports will be included in the RSC minutes.

d. Reestablishment of investigational levels to levels above those listed in Table 1.
 

In cases where a worker's or a group of workers' doses need to exceed an investigational level, a new, higher investigational level may be established for that individual or group on the basis that it is consistent with good ALARA practices. Justification for new investigational levels will be documented.
 

The RSC will review the justification for and must approve or disapprove all revisions of investigational levels.
 

7. Signature of Certifying Official (The person who is authorized to make commitments for the administration of the institution, (e.g., hospital administrator).
 

I hereby certify that this institution has implemented the ALARA Program set forth above.
 
 
 

Signature
 
 
 

Name and Title (print or type)

APPENDIX M
 

STANDARDS FOR PROTECTION AGAINST RADIATION
 

PREGNANT EMPLOYEES
 

All potentially pregnant employees must be informed about radiation risk to the conceptus; employer must document.
 

Employees most declare pregnancy in writing.
 

EXPOSURE LIMITS
 

Fetal dose limit of 5 mSv (500 mrem) is uniformly distributed during time of gestation period.
 

Must badge anyone if possibility of exceeding ten percent (10%) of annual limit; for pregnant employees and minors would be 0.05 mSv/month.
 

Annual dose limit is 50 mSv. Cumulative limit is 10 mSv X age.
 

1 mSv/year limit to public will require more vacant rooms when doing radionuclide therapy and may require shielding changes as per Regulations.
 

Sum of internal and external doses is required if both exceed ten percent (10%) of annual limit; scheme for determining effective dose is arbitrary and complex.
 

Calculation and maintenance of records relative to any long lived radionuclide committed dose may be necessary for medical research workers.
 

POSTING
 

Where exposure rate exceeds 0.05 mSv/hr, area must be posted as a "Radiation Area," e.g. radionuclide therapy patient rooms.
 

LABELING
 

All unattended containers of radioactive material which exceed limits must have label with "Caution Radioactive Material," radiation warning symbol, type of radionuclide, activity, date, radiation level if "Significant." Labels must be defaced before disposal, e.g. 1 mCi of ¹²⁵I in test tube sitting on counter during lunch break must be labeled.
 

REPORTING
 

Loss of more than ten (10) times quantities must be reported by telephone within 30 days e.g. 10 µCi discrepancy in ¹³¹I quantity.
 

Loss of more than 1000 tiems quanties must be reported by telephone immediately e.g. 1 mCi discrepancy in ¹³¹I therapy dose.
 

Member of the public receiving more than 1 mSv must be reported within 30 days e.g. family member whose unallowed visiting privileges exceeds 1 mSv.

APPENDIX N
 

DIAGNOSTIC AND/OR THERAPEUTIC PROCEDURE

MISADMINISTRATION REPORT
 

EVENT REPORT DATE
 

SERVICE PHYSICIAN
 

INVOLVED TECHNOLOGIST
 

TYPE OF MISADMINISTRATION: WRONG PATIENT

WRONG RADIOPHARMACEUTICAL

WRONG ROUTE

DOSAGE DIFFERING FROM PRESCRIBED BY 50%
 

INTENDED PROCEDURE
 

INTENDED RADIOPHARMACEUTICAL/DOSAGE
 

RADIOPHARMACEUTICAL/DOSAGE
 

PROCEDURE PERFORMED
 

REFERRING PHYSICIAN
 

PATIENT SOCIAL SECURITY NUMBER
 

RESPONSIBLE TECHNOLOGIST
 

CONTRIBUTING FACTOR
 
 
 
 
 
 
 

ACTION TAKEN TO PREVENT RECURRENCE
 
 
 
 
 
 
 

EFFECTS ON PATIENT
 
 
 
 
 
 
 

SIGNATURE DATE

RADIATION SAFETY OFFICER
 

TELEPHONE NUMBER

APPENDIX O

THERAPEUTIC RADIONUCLIDE CONSULTATION FORM

PATIENT DATE
 

HOSPITAL NUMBER WARD
 

IS REFERRED TO YOU. OUR FINDINGS IN THE CASE ARE AS FOLLOWS:
 
 

REQUEST FOR TREATMENT WITH THERAPEUTIC RADIOISOTOPE:

RADIOISOTOPE FORM AMOUNT METHOD AND DATE OF ADMINISTRATION
 

CURRENT MEDICATIONS
 

IS PATIENT PREGNANT?

DATE OF LAST MENSTRUAL PERIOD

HAS PATIENT BEEN INSTRUCTED TO AVOID PREGNANCY RIOR TO TREATMENT AND FOR TWO MONTHS AFTER TREATMENT?

RATIONALE FOR OTHER THAN ROUTINE USE
 
 
 
 
 
 

PHYSICIAN'S SIGNATURE
 

TO (PHYSICIAN)
 

THERAPIST
 

ASSISTANTS
 
 
 
 

DATE TIME RADIONUCLIDE DOSE TECHNIQUE
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

REMARKS:

APPENDIX P

QUALITY MANAGEMENT PROGRAM

Guidelines for Brachytherapy Applications, ⁹⁰Sr Applicator, Radiopharmaceutical Therapy and Administrationn of Greater than 30 mCi of ¹²⁵I or ¹³¹I.
 

I. Written Directive
 

The physician will issue a written directive in the patient's Radiation Oncology treatment chart and/or hospital chart prior to the administration of any brachytherapy or radiopharmaceutical. This directive will be signed and dated by the physician.
 

II. Patient Identification
 

Before administration of any dose, the patient's identity will be determined by more than one method by the person administering the dose. The methods of identification used are noted on the quality management checklist for administration of brachytherapy treatments or radiopharmaceuticals (see attached forms). This checklist becomes part of the patient's chart.
 

III. Verification of Dose
 

Final plans for treatment and/or dose calculation for brachytherapy are signed by the physician as verification of agreement with the written directive. For administration of radiopharmaceuticals, the quality management checklist is completed to verify the dose ordered in the written directive.
 

IV. Verification of Administration
 

Brachytherapy sources are loaded into the applicators or placed interstitially according to the treatment plan/dose calculation that follows the written directive. On-site brachytherapy sources are located in the storage safe according to a posted "map" of the contents of each drawer and are color-coded according to activity. The number and activity of the sources removed from the safe are verified by completing the source utilization log, which accounts for all sources remaining in the safe. Special-order sources are verified upon receipt for agreement with treatment plan and are intended to be patient-specific. The packing list of sources are filed in the source receipt log with a copy of a dose-calibrator print-out. Placement of the applicators and after-loaded sources in the patient are determined and verified by radiography using dummy sources. The source loading and its time of insertion and removal are documented in the patient's hospital chart. Radioactive seed applications are radiographed after surgery for verification of seed placement and dose calculation. For radiopharmaceutical administration, a copy of the dose-calibrator print-out is attached to the quality management checklist. For ⁹⁰Sr the treatment time and treatment dose shall be documented in the patient's hospital chart as well as on the ⁹⁰Sr Opthalmic Applicator Therapy Record.
 

V. Deviation from Written Directive
 

Any deviation from the written directive, intended or otherwise, is documented on the treatment plan and noted in the patient's hospital chart. The physician is consulted as to the appropriate measures to be taken.
 

VI. Quality Management Program Review (QMPR)
 

The QMPR will be reviewed annually for completeness and appropriateness by the radiation physicist, oncologist and RSO (see attached review form). Changes will be made as needed and submitted to the division within 30 days of the modification.
 

APPENDIX Q

ANNUAL REVIEW FORM

QUALITY MANAGEMENT PROGRAM

DATE:
 

Written program (policies and procedures)
 

Program approved by management
 

Incorporated into license
 

Modifications submitted within 30 days
 

Minutes of annual review
 

Review sample of patient administrations
 

Review of QM objectives and effectiveness
 

Review misadministrations
 

Review recordable events
 

Event facts written up within 30 days
 

Event corrective action recommended and evaluated
 

Record of patient dose
 

Written directive for brachytherapy dose
 

Written directive for radiopharmaceutical therapy dose
 

Record for ¹²⁵I and ¹³¹I greater than 30 microcuries
 

Patient identity verified by two (2) means
 

Therapy plans by directive
 

Unintended deviation from plan evaluated
 

Retention of records for three (3) years
 
 
 
 
 

Management
 
 
 

RSO
 

APPENDIX R

Quality Management Cheklist for Administration of Sodium Iodide (¹²⁵I, ¹³¹I)

Activities Greater than 30 mCi
 

Date:

Patient:

Social Security Number:

Date of Birth:
 

PATIENT IDENTIFICATION: (completed by person verifying patient identity).
 

The above patient's identity has been verified by at least two of the following methods: (Circle appropriate number)
 

1. Asking patient to state and spell his/her name and compare with patient's record/objective.

2. Comparing stated date of birth with patient's record/directive.

3. Comparing stated SS# with patient's record/directive.

4. Comparing stated address with patient's record/directive.

5. Comparing photographic identification (ex. driver's license) with patient's appearance.

6. Comparing in-patient identification wrist band with patient record/directive.

7. Relative/friend attests patient identity.

Name of attestor: Relationship:

Signature of both staff verifying the patient's identity:

/
 

RADIOPHARMACEUTICAL PRESCRIPTION: (completed by person administering radiopharmaceutical).
 

Procedure:

Attending Physician:

Ordering Physician:

Radiopharmaceutical Prescribed:

Route of Administration:

Dosage Ordered:

Signature of Administrator:
 

Radiopharmaceutical Dosage Verification (Completed by person administering radiopharmaceutical):
 

Radiopharmaceutical being administered:

Pharmaceutical Lot:

Calibrated at: mCi at:

Actual Dose from Calibrator: mCi at:

Route of Administration:

Date and Time Administered:

Signature of Administrator:

Imaging was Performed by:
 

COMPLICATIONS/COMMENTS/NOTES:

ATTACH DOSE CALIBRATOR SLIP

APPENDIX S

INSTRUCTIONS FOR BRACHYTHERAPY

A. Before prescribing a procedure, the authorized user or the physician under the supervision of an authorized user will personally review the patient's case to establish that the medical use is indicated for the patient's medical condition.
 

B. Before administering the radionuclide, the authorized user or the physician under the supervision of an authorized user will personally make and date a prescription.
 

C. Before implanting the sealed sources, a qualified person under the supervision of an authorized user will verify that the radionuclide and source strength of the sources to be used are as prescribed. (NOTE: The licensee may use any appropriate verification method, such as checking the serial number behind a shield, using a radiation detector or using clearly marked storage spaces for each type of sealed source).
 

D. Any change in the prescription will be recorded in writing in the patient's chart or in another appropriate record and will be dated and signed by the authorized user or the physician under the supervision of an authorized user.
 

E. After implanting the brachytherapy sources, radiographs will be obtained and used as the basis for calculating the delivered dose (this may not apply to sources used for surface application).
 

F. After implantation, a qualified person under the supervision of an authorized user will promptly update and sign the patient's record to reflect the actual loading of the sealed sources and record any change in the prescription.
 

G. After administering the brachytherapy dose, a qualified person under the supervision of an authorized user will make, date and sign a written record in the patient's chart or in another appropriate record describing the administered dose; and this person will record the agreement, or lack thereof, between the brachytherapy administration and the prescription.
 

H. Before 50% of the prescribed dose has been administered, a qualified person under the supervision of an authorized user (e.g., physicist, physician, dosimetrist or technologist) will check the dose calculations.
 

1. MANUAL DOSE CALCULATIONS WILL BE CHECKED FOR:
 

a. Mathematical errors
 

b. Correct transfer of data from the prescription, tables and graphs
 

c. Correct use of nomograms when applicable
 

d. Correct use of all pertinent data in the calculations.
 

2. Computer-generated dose calculations will be checked by examining the computer printout to ensure that the correct inputs for the patient were used in the calculations. Alternatively, the dose may be manually calculated to a key point and the results compared.
 

3. If the manual calculations are performed using computer outputs or vice versa, the manual portion of the calculations will be checked as stated in (a) and the computer portion of the calculations will be checked as stated in (b). Emphasis will be placed upon verifying the correct output from one (computer) to be used as an input in another type of calculation (manual).

OPERATING ROOM CARE

BRACHYTHERAPHY SOURCES

Method of Implantation:
 

Temporary:
 

Usually an intracavitary implantation of ¹³⁷Cs. Implantation may be delayed if an after-loading technique is employed. This involves insertion of an applicator before the radioactive sources are inserted.
 

Permanent:
 

An interstitial implantation that may be superficial, intraabdominal or intrathoracic. Permanent implants usually require only a single, simple surgical procedure. Many implants are performed under local anesthesia.
 

Danger to Personnel:
 

All radioactive sources emit radiation that is dangerous. Afterloading techniques present less hazard as sources of radioactivity are kept in shielded containers until applicator is in place. PREGNANT FEMALES ARE NOT TO ASSIST IN THE O. R.
 

Precautions in the O. R.:
 

The physician will handle the radioactive sources. The circulating nurse will open containers so that physician can remove radioactive sources. The container is to be closed immediately.
 

Sterilization:
 

Temporary implant, intracavitary ¹³⁷Cs, (Afterloading Technique) No sterilization required. Applicators will be contained in sterile packaging.
 

Temporary implant, intracavitary ¹³⁷Cs, (Afterloading Technique not employed): Radioactive sources should be soaked a minimum of ten (10) minutes in 70% ethanol. This is a disinfecting procedure; sources shall not be steam sterilized.
 

Temporary implant, interstitial ¹³⁷Cs: Radioactive sources should be soaked a minimum of ten (10) hours in two percent (2%) glutaraldehyde. Date of activation of glutaraldehyde shall be indicated and solution not used fourteen (14) days after activation. Sources shall be carefully removed with sterile technique and adequately rinsed with sterile water to remove all glutaraldehyde residue before implantation. Sources shall not be steam sterilized.
 

Permanent implant, interstitial ¹²⁵I, ¹⁹²Ir: Sources may be steam sterilized (121 degree C); follow physician's instructions.
 

NURSING CARE

BRACHYTHERAPY SEALED SOURCES/RADIOPHARMACEUTICAL THERAPY

Patient Room
 

Hospital Number Physician
 

Radionuclide Number of Sources Activity
 

Source Administation / Source Removal /

Date Time Date Time
 

Exposure Rate @ 1 meter mR/hr / By

Date Time

I. Checked Items Required:

Waste Basket, Plastic Liner

Laundry Bag

Impermeable Disposable Gloves

Paper Towels

Disposal Eating Utensils (Isolation Tray)
 

II. Checked Itens Shall Be Observed:
 

1. Private room with toilet mandatory.

2. Patient may not have visitors. Exception:
 

3. No pregnant visitors. Female visitors should be asked if they are pregnant.
 

4. No visitors under eighteen (18) years of age.
 

5. No adjacent patient or visitor shall be placed within 1.8 meters (six (6) feet) of the patient.
 

6. Pregnant nurses and attendants shall NOT be responsible for routine care of this patient.
 

7. Wear impermeable disposable gloves when handling urinals, bed pans, emesis basins or other containers having any material obtained from the body of the patient. Wash impermeable disposable gloves before removing and then wash hands. The impermeable disposable gloves must be left in the patient's room in the designated waste container. These impermeable disposable gloves need not be sterile.
 

8. Nurses or other attendants shall not remain in the immediate proximity, 61 cm (two (2) feet) of the patient for more than a total of .
 

9. Housekeeping may not enter the room.
 

10.Dietary may not enter the room.
 

11. Dietary shall furnish an Isolation Tray. Disposable items, including disposable plates, cups and eating utensils used by the patient shall be placed in the designated waste container. Contact Nuclear Medicine Ext for proper disposal of the contents of the designated waste container.
 

12. All clothes and bed linens used by the patient should be placed in the laundry bag provided and left in the patient's room to be checked by Nuclear Medicine Ext .
 

13. Surgical bandages and dressings shall be changed only by the physician in charge or another individual designated by him and trained in techniques applicable to such cases.
 

14. Bed bath should be omitted while sources are in place.
 

15. Patient shall remain in bed unless orders to the contrary are written.
 

16. For gynecological patients, perineal care is not ordinarily given during the treatment, but the perineal pad may be changed when necessary.
 

17. No sources (needles or tubes) are to be removed by anyone other than the physician named above.
 

18. IF A SOURCE SHOULD GET FREE, it shall immediately be picked up with forceps and put in the corner of the room or placed in a container which is to be left in the room until the arrival of the physician and/or the RSO. Immediately contact:
 

Doctor Phone

RSO Phone
 

19. Vomiting within 24 hours after administration of treatment, urinary incontinence or excessive sweating within the first 48 hours may result in contamination of linen and/or floor. If radioactive urine and/or feces is spilled, call Nuclear Medicine Ext . Handle all contaminated material with impermeable disposable gloves and avoid spreading contamination.
 

20. The same toilet should be used by the patient at all times and it should be flushed three (3) times after use.
 

21. Nurses or attendants suspecting that their skin or clothing, including shoes, is contaminated shall notify Nuclear Medicine Ext . This person should remain in the patient's room and not walk around the hospital. If hands become contaminated, wash immediately with soap and water.
 

22. IN THE EVENT OF DEATH OR EMERGENCY SURGERY, immediately notify

M.D.,Phone No.

and RSO Phone No.

Do not remove the body from the room in event of death.
 

23. No patient is to be released from the hospital until all radioactive material is removed or decayed to safe levels.
 

24. At the conclusion of treatment, contact Nuclear Medicine Ext and request a survey of the patient and room. In addition, survey any other area occupied by the patient to ensure that all sources have been removed from the patient and the room. At this time, all radiation signs will be removed and the room will be released for general use.
 

25. Other instructions.

RADIONUCLIDE THERAPY SURVEY

Survey of the patient's room and surrounding areas shall be conducted as soon as practicable after administration of radionuclide and at conclusion of treatment to ensure that all sources have been removed from the patient and that no sources remain in the patient's room or other area occupied by the patient.
 

PATIENT Room
 

HOSPITAL NO. AGE SEX
 

THERAPIST
 

PERMANENT IMPLANT OR INTERNAL DOSE TEMPORARY IMPLANT
 

SOURCE ADMINISTRATION / SOURCE REMOVAL
 

RADIONUCLIDE TREATMENT DOSE TECHNIQUE
 

INSTRUMENT USED MODEL SERIAL BKG mR/hr
 

RADIATION SURVEY OF PATIENT & RADIATION SURVEY OF PATIENT &

SURROUNDING AFTER ADMINISTRATION SURROUNDING AT CONCLUSION OF TREATMENT
 

DATE DATE

TIME TIME

SURVEYOR SURVEYOR
 
 
 

LOCATION mR/hr LOCATION mR/hr

Max @ Surface of Patient Max @ Surface of Patient

Max @ 1 meter from Patient Max @ 1 meter from Patient

Patient's Bedside, Left Patient's Bedside, Left

Patient's Bedside, Right Patient's Bedside, Right

Patient's Bedside, Foot Patient's Bedside, Foot

Entrance Door Entrance Door

Adjacent Room Adjacent Room

Adjacent Room Adjacent Room

Max in Unrestricted Area Max in Unrestricted Area

(Identify) (Identify)
 
 
 

SKETCH: (If Applicable)
 

"X" indicates location of radiation warning sign, patient bed and chart also posted.

APPENDIX W
 

ACTIVITIES AND DOSE RATES FOR AUTHORIZING PATIENT RELEASE

COLUMN 1 COLUMN 2

ACTIVITIES AT OR BELOW WHICH DOSE RATE AT 1 METER, AT OR

PATIENTS MAY BE RELEASED BELOW WHICH PATIENTS MAY BE

RELEASED*

RADIONUCLIDE Gbq mCi mSv/hr mrem/hr

¹¹¹Ag 19 520 0.08 8

¹⁹⁸Au 3.5 93 0.21 21

⁵¹Cr 4.8 130 0.02 2

⁶⁴Cu 8.4 230 0.27 27

⁶⁷Cu 14 390 0.22 22

⁶⁷Ga 8.7 240 0.18 18

¹²³I 6.0 160 0.26 26

¹²⁵I 0.25 7 0.01 1

¹²⁵I implant 0.33 9 0.01 1

¹³¹I 1.2 33 0.07 7

¹¹¹In 2.4 64 0.2 20

¹⁹²Ir implant 0.074 2 0.008 0.8

³²P ** ** ** **

¹⁰³Pd 1.5 40 0.03 3

¹⁸⁶Re 28 770 0.15 15

¹⁸⁸Re 29 790 0.20 20

⁴⁷Sc 11 310 0.17 17

⁷⁵Se 0.089 2 0.005 0.5

¹⁵³Sm 26 700 0.3 30

^117mSm 1.1 29 0.04 4

⁸⁹Sr ** ** ** **

^99mTc 28 760 0.58 58

²⁰¹Tl 16 430 0.19 19

⁹⁰Y ** ** ** **

¹⁶⁹Yb 0.37 10 0.02 2

The activity values were computed based on 5 millisieverts (0.5 rem) total effective dose equivalent.

*If the release is based on the dose rate at 1 meter in Column 2, the licensee must maintain a record as required by 10CFR35.75(c) because the measurement includes shielding by tissue. See Regulatory Position 3.1, "Records of Release," for information on records.

**Activity and dose rate limits are not applicable in this case because of the minimal exposures to members of the public resulting from activities normally administered for diagnostic or therapeutic purposes.
 

NOTES: The mCi values were calculated using Equations 2 or 3 and the physical half-life. The Gbq values were calculated based on the mCi values and the conversion factor from mCi to Gbq. The dose rate values are calculated based on the mCi values and the exposure rate constants.

In general, the values are rounded to two (2) significant figures. However, values less than 0.37 Gbq (10 mCi) or 0.1 mSv (10 mrem) per hour are rounded to one significant figure. Details of the calculations are provided in NUREG-1492 (Ref. 2).

Although non-byproduct materials are not regulated by the NRC, information on non-byproduct material is included in this guide for the convenience of the licensee.

Agreement State regulations may vary. Agreement State licensees should check with the State regulations prior to using these values.
 

APPENDIX X
 

ACTIVITIES AND DOSE RATES ABOVE WHICH INSTRUCTIONS SHOULD BE

GIVEN WHEN AUTHORIZING PATIENT RELEASE*

COLUMN 1 COLUMN 2

ACTIVITY ABOVE WHICH DOSE RATE AT 1 METER

INSTRUCTIONS ARE REQUIRED ABOVE WHICH INSTRUC-

TIONS ARE REQUIRED

RADIONUCLIDE Gbq mCi mSv/hr mrem/hr

¹¹¹Ag 3.8 100 0.02 2

¹⁹⁸Au 0.69 19 0.04 4

⁵¹Cr 0.96 26 0.004 0.4

⁶⁴Cu 1.7 45 0.05 5

⁶⁷Cu 2.9 77 0.04 4

⁶⁷Ga 1.7 47 0.04 4

¹²³I 1.2 33 0.05 5

¹²⁵I 0.05 1 0.002 0.2

¹²⁵I implant 0.074 2 0.002 0.2

¹³¹I 0.24 7 0.02 2

¹¹¹In 0.47 13 0.04 4

¹⁹²Ir implant 0.011 0.3 0.002 0.2

³²P ** ** ** **

¹⁰³Pd 0.3 8 0.007 0.7

¹⁸⁶Re 5.7 150 0.03 3

¹⁸⁸Re 5.8 160 0.04 4

⁴⁷Sc 2.3 62 0.03 3

⁷⁵Se 0.018 0.5 0.001 0.1

¹⁵³Sm 5.2 140 0.06 6

^117mSm 0.21 6 0.009 0.9

⁸⁹Sr ** ** ** **

^99mTc 5.6 150 0.12 12

²⁰¹Tl 3.1 85 0.04 4

⁹⁰Y ** ** ** **

¹⁶⁹Yb 0.73 2 0.004 0.4

*The activity values were computed based on 1 millisieverts (0.1 rem) total effective dose equivalent.

**Activity and dose rate limits are not applicable in this case because of the minimal exposures to members of the public resulting from activities normally administered for diagnostic or therapeutic purposes.
 

NOTES: The mCi values were calculated using Equations 2 or 3 and the physical half-life. The Gbq values were calculated based on the mCi values and the conversion factor from mCi to Gbq. The dose rate values are calculated based on the mCi values and the exposure rate constants.

In general, the values are rounded to two (2) significant figures. However, values less than 0.37 Gbq (10 mCi) or 0.1 mSv (10 mrem) per hour are rounded to one significant figure. Details of the calculations are provided in NUREG-1492 (Ref. 2).

Although non-byproduct materials are not regulated by the NRC, information on non-byproduct material is included in this guide for the convenience of the licensee.

Agreement State regulations may vary. Agreement State licensees should check with the State regulations prior to using these values.

APPENDIX Y
 

ACTIVITIES OF RADIOPHARMACEUTICALS THAT REQUIRE INSTRUCTIONS AND RECORDS WHEN ADMINISTERED TO PATIENTS WHO ARE BREAST-FEEDING AN INFANT OR CHILD
 

COLUMN 1 COLUMN 2 COLUMN 3

ACTIVITY ABOVE WHICH ACTIVITY ABOVE WHICH EXAMPLES OF

INSTRUCTIONS ARE REQUIRED A RECORD IS REQUIRED RECOMMENDED

DURATION OF

INTERRUPTION OF

BREAST-FEEDING*

RADIONUCLIDE MBq mCi MBq mCi

¹³¹I NaI 0.01 0.0004 0.07 0.002 Complete cessation

(for this infant or child)
 

¹²³I NaI 20 0.5 100 3

¹²³I OIH 100 4 700 20

¹²³I mIBG 70 2 400 10 24 hr for 370 MBq

(10 mCi)

12 hr for 150 MBq

(4 mCi)

¹²⁵I OIH 3 0.08 10 0.4

¹³¹I OIH 10 0.30 60 1.5

^99mTc DTPA 1,000 30 6,000 150

^99mTc MAA 50 1.3 200 6.5 12.6 hr for 150

MBq (4 mCi)

^99mTc Pertechnetate 100 3 600 15 24 hr for 1,100

MBq (30 mCi)

12 hr for 440 MBq

(12 mCi)

⁹⁹ⁿTc DISIDA 1,000 30 6,000 150

^99mTc Glucoheptonate 1,000 30 6,000 170

^99mTc HAM 400 10 2,000 50

^99mTc MIBI 1,000 30 6,000 150

^99mTc MDP 1,000 30 6,000 150

^99mTc PYP 900 25 4,000 120

^99mTc Red Blood Cell 400 10 2,000 50 6 hr for 740 MBq

In Vivo Labeling (20 mCi)

^99mTc Red Blood Cell 1,000 30 6,000 150

In Vitro Labeling

^99mTc Sulphur Colloid 300 7 1,000 35 6 hr for 440 MBq

(12 mCi)

^99mTc DTPA Aerosol 1,000 30 6,000 150

^99mTc MAG3 1,000 30 6,000 150

^99mTc White Blood 100 4 600 15 24 hr for 1,100

Cells MBq(5 mCi)

12 hr for 440 MBq

(2 mCi)

⁶⁷Ga Citrate 1 0.04 7 0.2 1 month for 150

MBq (4 mCi)

2 weeks for 50 MBq

(1.3 mCi)

1 week for 7 MBq

(0.2 mCi)

⁵¹Cr EDTA 60 1.6 300 8

¹¹¹In White Blood 10 0.2 40 1 1 week fpr 20 MBq

Cells (0.5 mCi)

²⁰¹Tl Chloride 40 1 200 5 2 weeks for 110

MBq (3 mCi)

*The duration of interruption of breast-feeding is selected to reduce the maximum dose to a newborn infant to less than 1 mSv (0.1 rem), although the regulatory limit is 5 mSv (0.5 rem). The actual doses that would be received by most infants would be far below 1 mSv (0.1 rem). Of course, the physician may use discretion in the recommendation, increasing or decreasing the duration of interruption.
 

NOTES: Activities are rounded to one significant figure, except when it was considered appropriate to use two significant figures. Details of the calculations are shown in NUREG-1492, "Regulatory Analysis on Criteria for the Release of Patients Administered Radioactive Material" (Ref. 2).
 

If there is no recommendation in Column 3 of this table, the maximum activity normally administered is below the activities that require instructions on interruption or discontinuation on breast-feeding.
 

Although non-byproduct materials are not regulated by the NRC, information on non-byproduct material is included in this guide for the convenience of the licensee.
 

Agreement State regulations may vary. Agreement State licensees should check with the State regulations prior to using these values.

APPENDIX Z

 
 

HOME INSTRUCTION, RADIOPHARMACEUTICAL THERAPY

Patient,

observe these instructions for days.
 
 
 

1. Sleep alone. If employed, take days off from work.
 

2. Whenever possible use separate toilet facilities that are not used by other members of the family.
 

3. Use care so that the area around the toilet is not soiled with urine. Flush the toilet three (3) times after each use.
 

4. Bed linens and underclothing should be washed separately afterr the other washing has been completed. Then the tub or washing machine should be rinsed twice.
 

5. Wash bathtub or shower with soap and cleanser after tub or shower bath.
 

6. Contact the Nuclear Medicine Department, , if you have questions.
 
 
 
 
 
 
 
 
 

M.D.
 

APPENDIX AA
 

HOME INSTRUCTIONS
 

Patient:
 

A small radioactive skource has been placed (implanted) inside your body. The source is actually many small metallic pellets or seeds, which are each about 1/3 to 1/4 of an inch long, similar in size and shape to a grain of rice. To minimize exposure to radiation to others from the source inside your body, you should do the following for days.
 

1. Stay a distance of feet from .
 

2. Maintain separate sleeping arrangements.
 

3. Minimize time with children and pregnant women.
 

4. Do not hold or cuddle children.
 

5. Avoid public transportation.
 

6. Examine any bandages or linens that come into contact with the implant site for any pellets that may have come out of the implant site.
 

7. If you find a seed or pellet that falls out:
 

DO NOT HANDLE it with you fingers. Use something like a spoon or tweezers to place it in a jar or other container that you may close with a lid.
 

Place the container with the seed or pellet in a location away from people.
 

Notify your physician at once.
 
 
 
 
 

M.D.
 

APPENDIX BB

⁹⁰STRONTIUM OPHTHALMIC APPLICATOR THERAPY RECORD

Patient Date:
 

Hospital No. Room Age Sex
 

Therapist M.D.
 

DATE TIME SOURCE TREATMENT TREATMENT TECHNIQUE TIME SOURCE

REMOVED TIME DOSE RETURNED TO

FROM NUCLEAR NUCLEAR

RADIOLOGY RADIOLOGY

LABORATORY LABORATORY
 
 

APPENDIX CC

INSTRUCTIONS FOR FAMILY OF RELEASED PATIENT

Patient Name
 

For further information contact Phone No.
 

Please show this form to every physician consulted concerning the patient

until (DATE)
 

Patient Name was treated on

with mCi of in the form of

NO SPECIAL RADIATION SAFETY PRECAUTIONS ARE REQUIRED AFTER(DATE)
 

UNTIL THAT DATE:

Persons under 45 years of age should not remain closer than the following distances from the patient for the time period indicated below:
 

to

Date Date
 

Permissible distance feet or more for hours/week. At other times, remain farther than six (6) feet.
 

SPECIAL PRECAUTIONS:
 

a) Spouse or other individuals caring for patient:

b) Children or pregnant women:

c) Sleeping arrangements:
 
 
 
 
 

If the patient is to be hospitalized, or if death should occur, notify the following individuals immediately:
 
 
 
 

(A copy of this form should be kept with the patient's record.)
 

APPENDIX DD
 

REPORT OF RADIOACTIVITY OF CADAVER
 

The physician in charge of the case should fill out the following and attach to the patient's chart and death certificate. The Radiation Safety Officer is available for assistance to the physician.
 

Hospital:
 

Name of Deceased:
 

Hospital Number: Date and Time of Death:
 

Diagnosis:
 

Radioactivity Survey - Before Autopsy:
 

Radionuclide: Activity (mCi):
 

Last Treatment Date: Hour: a.m.;p.m.
 

Survey Date: Hour: a.m.;p.m.
 

Elapsed Time from Last Treatment to Survey in Days:
 

Maximum Level of Radiation @ Surface of Body (mR/hr):
 

Instrument Used:
 

Model #: Serial #: Calibration Date:
 

Signed:

Radiation Safety Officer

APPENDIX EE

INSTRUCTIONS TO FUNERAL DIRECTOR FOR EMBALMING BODY

CONTAINING RADIOACTIVE MATERIAL

Hospital:
 

Name of Deceased:
 

Date of Death:
 

Radionuclide Used: Half-life: Radiation Emitted:
 

Chemical Form:
 

Estimated Activity at Time of Death (mCi):
 

Critical Organs or Sites:
 

This is to certify that the remains of
 

have been examined on by

Date Radiation Safety Officer
 
 
 

This body does not contain significant amounts of radioactive material. No special precautions are required if standard embalming practices are used.
 

This body contains significant amounts of radioactive material. The following precautions are to be observed:
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Radiation Safety Officer
 
 
 

Date
 

APPENDIX FF

AUTOPSY OR SURGERY PRECAUTIONS

The following are main precautions required for autopsies or surgery on bodies containing large doses of radionuclides:
 

A. General
 

1. Impermeable disposable gloves must always be worn to prevent contamination of skin and nails with material difficult to remove.
 

2. If the combined beta and gamma dose rate is high enough to deliver more than the permissible dose to hand or whole body, the autopsy or surgery should be performed by a team of physicians working in relay.
 

3. Tissue and organs removed should be handled with long handled forceps and scissors. Specimens should be refrigerated in jars or other containers, or fixed, and suitably labeled to indicate when they can safely be worked on and studied.
 

B. Special
 

1. All tissues and body fluids should be surveyed by the RSO and handled according to his recommendations. Urine and blood should be removed and stored or disposed.
 

2. Tissue specimens held three (3) months can be considered inactive.

APPENDIX GG

MAMMOGRAPHY REQUIREMENTS

Person taking X-ray must be:
 

a. ARRT Certified; and
 

b. State licensed; and
 

c. fifteen (15) hours continuing education every three (3) years; and
 

d. 40 hours formal mammography class and documentation or
 

e. have passed mammography registry for ARRT.
 

Requirements for Physicist:
 

1. State approved or certified by the American Board of Radiology; and
 

2. Fifteen (15) hours continuing education over three (3) years; and
 

3. Must have performed at least ten (10) surveys in a twelve (12) month period.
 

Requirements for Radiologist:
 

1. State licensed and certified by the American Board of Radiology, the American Osteopathic Board of Radiology or the RPCSP; and
 

2. Fifteen (15) hours continuing education every three (3) years; and
 

3. Prove that he or she has read 40 patient films per month for a two year period.
 

IF PRACTICING BEFORE 01 OCTOBER 94:
 

4. Must meet requirements one through three (1-3) in addition to having 40 hours of continuing education on mammography specific and having read 240 patient films in six (6) months.
 

The following items are required to have an adequate QC/QA Program:
 

1. Physicist survey report;
 

2. Processor QC/QA (daily strips and phantom images);
 

3. Records and test results performed on associated equipment as required by the ACR Manual, i.e.:
 

a. Compression test
 

b. Fixer retention test
 

c. Film screen contact test
 

d. Darkroom fog test
 

e. Screen cleaning
 

f. Viewbox and viewing conditions
 

g. Visual check list
 

h. Repeat analysis
 

4. Last MQSA Inspection Report
 

5. State Registration Certificate
 

6. If the unit is being transported to different location(s), then the above records are required to be with the unit.
 

Under Mammography Quality Standards Acts (MQSA) of 1992, all physicians interpreting mammograms must have general qualifications in rqadiography, have initial training and experience in mammography and must maintain their qualifications over time. Physicisns must be licensed to plactice medicine by a state. They must be certified in diagnostic radiology by an FDA approved accreditation body or have had at least two (2) months of full-time training in the interpretation of mammograms.
 

All interpreting physicians must have at least 40 hours of continuing medical education (CME) units in mammography and have the initial experience of interpreting the mammograms from at least 240 examinations in the previous six (6) month period. Interpreting physicians must continue to interpret the mammograms from an average of at least 40 examinations per month (averaged over a 24-month period) and must continue to earn an average of at least five (5) CME units per year.
 

If the physician in not certified by an approved board, he or she may present evidence of at least two (2) months of full-time training in the interpretation of mammograms, including instruction in radiation physics, radiation effects and radiation protection. They must also meet the licensing, training and experience requirements as must board-certified physicians.
 

FDA MQSA HOTLINE
 

Mammography Quality Assurance Program

Food and Drug Administration

P.O. Box 6057

Columbia, MD 21045-6057
 

TELEPHONE: 1-800-383-7715

FAX 410-290-6351

APPENDIX HH
 

RADIATION SAFETY COMMITTEE
 

NOTE: THIS FORM SHALL BE TYPED!
 

APPLICATION FOR AUTHORIZATION TO USE RADIONUCLIDES/RADIATION SOURCES FOR

IN VIVO HUMAN USE
 

1. Date: New Application Amendment Renewal
 

2. Applicant Name: Degree:
 

Department: Box Number:
 

Telephone Number:
 

3. Description of Radiation Source(s). Describe all the radiation sources that subjects will encounter:
 

a. Radioactive Material:

Compound & Number of

Each Activity Each Method of Administrations

Radionuclide Administration Administration Each Subject
 

Where will the material be administered and by whom?
 
 
 

b. X-Ray Radiography:
 

Type File mAs/ Number of Entrance

Exam Size kVp film Films/Exam Distance Filter mR
 
 
 

Where will radiography occur and who will supervise?
 

c. Fluoroscopy:
 

Anatomical Beam Fluoroscop Entrance Exposure

Area Size kVp mA Time Rate (mR/mA-minute)
 

Where will fluoroscopy occur and who will supervise?
 

4. Experimental Limitations:
 

a. Explain why it is necessary to use radiation rather that alternate procedures:
 

b. Explain the factors that determine the minimum amount of radiation that is necessary, i.e. limits based of instrument sensitivity or physiological parameters:
 

5. Description of Subjects and Selection Criteria
 

a. Age Distribution:
 

b. Sex:
 

c. Special basis for selection (disease, abnormality, occupation, etc.):
 

d. Number of special selected subjects:
 

e. Indicate time frame; how many subjects will be studied each year?
 

f. How will the subject benefit from the study?
 

g. Are potential subjects rejected if they are or might be pregnant?

How is nonpregnancy assured?
 

h. Are potential subjects rejected if they:
 

1) Had volunteered for similar studies within the past year?
 

2) Had significant medical exposure?
 

3) Receive significant occupational exposure?
 

How are these conditions assured?
 
 
 
 
 
 
 
 
 

6. Radiation Protection for Subjects:
 

Describe all methods for protecting the subject from unnecessary radiation, i.e. gonadal shielding, thyroid block against iodine, etc.:
 

7. Radiation Dosimetry:
 

Include dosimetry calculations and summary of radiation doses. References should be cited if used:
 

8. Summary of Risk to Subject:
 

Attach copy of Consent Form to be employed.
 
 
 
 
 
 
 

9. The Committee on Use of Human Subjects:
 

Pending review
 

Approved

(Date)
 

10. Experience Form Attached: Yes No
 
 
 
 
 
 
 

Applicant's Signature:

(IN INK SIGNATURE AND DATE)
 
 
 

11. Review by Radiation Safety Committee:
 
 
 

By: Date:
 

Recommendation: Approve Disapprove
 

Comments:
 

RADIATION SAFETY COMMITTEE

EXPERIENCE FORM

FOR

IN VIVO HUMAN RADIATION USE

NAME: DATE:
 

DEPARTMENT:
 
 
 

Formal Courses:
 

Give names of formal courses taken which would assist in the understanding of radiation protection problems (e.g. nuclear or atomic physics, health physics, radionuclide technology, radiation biology, etc.). Specify when and where taken.
 

Practical Experience:

Summarize in 200 words or less. Indicate radionuclides and chemical forms used, amounts, when and where:
 

RADIATION SAFETY COMMITTEE
 

NOTE: THIS FORM SHALL BE TYPED!
 

APPLICATION FOR USE OF RADIOACTIVE MATERIAL/RADIATION SOURCE

1. Date: New Application Amendment Renewal
 

2. Applicant Name: Degree:
 

Department: Box Number:
 

Telephone Number:
 

3. Check Catagory for Intended Use:
 

Animal Use
 

Class Room Use
 

In Vitro Procedure:
 

Animal Use
 

Human Use
 

In Vivo Human Use

(If In Vivo Human Use, Form 101 shall be completed)

4. Radiation Source(s):

Chemical/Physical Maximum mCi Maximum mCi Use

Radionuclide Form Possession (Orders/Month)
 

Describe other radiation sources (i.e. x-ray unit, x-ray diffraction, etc.):
 
 
 
 
 

5. Describe proposed use of each item:
 

6. List individuals who will handle requested material (Name and Title/Position):
 

7. List Radiation Detection Instruments available (survey meter, beta/gamma counting systems, etc.):

Type Manufacturer Model # Radiation Location

Detected (Room Number)
 

List radiation sources available (x-ray units, diffraction units, sealed sources, etc.):

Type Manufacturer Model # Location (Room Number)
 

8. Describe Storage of Material (Facilities, Containers, Special Shielding):
 

9. Describe Handling of Material (Protective Equipment, Special Handling Tools, Hoods):
 

10. Describe special laboratory radiation safety practices, including monitoring practices:
 

11. Describe waste disposal procedures and estimate quantities per month of liquid, solid waste. Describe type of waste anticipated (i.e. aqueous or nonaqueous, infectious, flammable, etc.):
 

12. Indicate rooms where radioactive materials and/or sources of radiation will be stored, used, and site for sewer disposal, if appropriate, by drawing a floor plan of the facility:
 

13. For In Vitro Human Use:
 

a. Attach Consent Form to be employed.
 

b. Committee on Use of Human Subjects:
 

Pending Review:
 

Approved:

(Date)
 

14. Experience Form Attached: Yes No
 

15. Applicant's Signature:

(In ink signature and date)
 

16. Review by Radiation Safety Committee:
 

By: Date:
 

Recommendation: Approve Disapprove
 

Comments:
 
 

RADIATION SAFETY COMMITTEE

EXPERIENCE FORM

FOR

NON-HUMAN USE OF RADIOACTIVE MATERIAL/RADIATION SOURCE

NAME: DATE:
 

DEPARTMENT:
 
 
 

Formal Courses:

Give names of formal courses taken which would assist in the understanding of radiation protection problems (e.g. nuclear or atomic physics, health physics, radionuclide technology, radiation biology, etc.). Specify when and where taken.
 

Practical Experience:

Summarize in 200 words or less. Indicate radionuclides and chemical forms used, amounts, when, and where:
 

APPENDIX II
 

AUTHORIZATION TO USE RADIONUCLIDES: RESEARCH FACILITIES/LABORATORIES
 

Research facilities or laboratories operate under the auspices of an institution's radioactive materials license issued by the Radiation Protection Division. The investigator must be familiar with the use of radioactive materials. All protocols will be reviewed by the RSC; authorization to utilize radioactive materials will be determined by the RSC. The investigator is responsible for submitting renewal or termination requests to the RSC.
 

Annually, the RSO will review and audit each investigator's procedures and protocols. The RSC will be notified of the findings of the RSO.
 

ORDERING PROCESS
 

Investigators shall purchase radionuclides by purchase requisition and shall not exceed maximum possission activity limits. The radionuclide ordered shall be within the maximum possession activity authorized by the RSC.
 

DELIVERY PROCESS
 

Radioactive material delivered to the investigator shall be wipe-tested for contamination and the results recorded.
 

RADIONUCLIDE ACCOUNTING
 

Records of orders, receipt and distribution of radioactive materials shall be maintained. Radionuclide inventories shall be submitted promptly.
 

LABORATORY MONITORING
 

Logs must be kept for removable contamination in every laboratory employing radionuclides.
 

STORAGE OF STOCK AND ASSAY SAMPLES
 

Radionuclides shall be stored in a shielded secure site. Lead bricks are advisable for high energy gamma emitters.
 

A refrigerator or freezer is adequate for low energy gamma sources and beta sources (e.g., ³H and ¹⁴C). High energy beta sources (e.g., ³²P) should be kept in plastic containers to limit the emission of bremstrahlung.
 

RADIOACTIVE WASTE DISPOSAL
 

Dry solid waste such as pipettes, gloves, paper, tubes and other solid materials shall be placed in radioactive waste bags tagged with "Caution Radioactive Material" labels. Include investigator's name, type and quantity of radionuclide on the label. Research personnel will take their own radioactive waste to the Radioactive Waste Room.
 

Radioactive animal carcasses and biological tissues shabb be bagged and labeled with the investigator's name, quantity and type of radionuclide. A designated radioactive waste freezer shall be used for storage. Animals containing 0.05 µCi/g of ³H or ¹⁴C can be treated as non-radioactive.
 

ANIMAL ROOM MONITORING
 

If radioactive material is administered to animals, the room in which the animals are housed must be lebeled with a "Caution Radioactive Materials" sign.
 

To protect against radioactive contamination of animal rooms, all surfaces shall be non-porous and easily washable. Cracks and crevices should be sealed. Rubber or vinyl tyles or linoleum applied over a floor will provide adequate protection provided they are non-porous and easily removed.
 
 
 

Periodic monitoring of animals shall be done by the authorized user. Dose rates shall be measured and recorded at a distance of one foot from the animals at the initiation of each new experiment. Dose rate meters are to be posted in a conspicuous place. If the dose rate at one foot is greater than 2 mR/hr, contact the RSO.
 

Facilities for holding radioactive waste and animal carcasses shall be provided by the authorized user.
 

Mechanical washing equipment shall be of a type that will facilitate decontamination of cage equipment but will not itself accumulate radioactive waste. Radioactive cages should be washed in machines which recirculate the wash solution until radioactivity has decayed.
 

RESEARCH EXCHANGE OF RADIOACTIVE MATERIAL
 

The interchange and use of radionuclides from researchers of another institution is permitted provided:
 

*1. Both institutions are licensed to possess the radionuclides being transferred.
 

2. Both researchers are authorized to use the material by their respective RSC.
 

3. The transfer container is adequate to protect the courier and persons enroute as well as the material itself.
 

*4. A proper receipt form is prepared to accompany and verify receipt of the material.
 

*Items one (1) and four (4) do not apply to a transfer within the facility.
 

RADIOACTIVE SPILL REPORT
 

Spill occurred at a.m./p.m. on in room
 

Instrument used: Model: Serial:
 

Personnel Present Personnel Contamination Results*
 
 
 
 
 
 
 

*On the back of this form, indicate any personnel decontamination, additional monitoring or care instituted.
 

Survey the spill area to identify high activity areas, then begin decontamination. When completed, conduct a post-cleaning contamination wipe-test.
 

Radionuclides present or suspected in the spill:
 

mCi Chemical Form:
 

mCi Chemical Form:
 

mCi Chemical Form:
 

Description of the accident:
 
 
 
 
 
 
 

Description of follow-up actions taken to prevent recurrence:
 
 
 
 
 
 
 

Name:
 

Date:
 

IODINATION ROOM RULES
 

1. USE hoods.
 

2. Wipe test the ENTIRE hood surface prior to iodination.
 

3. Record on the proper form the hood being utilized and the pre-iodination wipe test counts.
 

4. USE ABSORBENT MATTING. Cover the entire surface of the hood.
 

5. Wipe test the ENTIRE surface of the hood post-iodination.
 

NOTE:
 

Users are responsible for the cleanliness of the hoods. The user listed as the most recent will be required to decontaminate a hood found radioactive. Anyone found repeatedly contaminating a hood following a procedure will have their iodination privileges revoked.
 

Thyroid surveys shall be conducted on anyone performing "open" procedures (iodination) using 10 mCi or more of unbound ¹²⁵I or ¹³¹I. Unbound iodide can vaporize and be inhaled, subsequently localizing in the thyroid gland. Schedule a pre-iodination survey if you are planning a procedure with 10 mCi or greater.
 

RADIONUCLIDES COMMONLY USED IN RESEARCH LABORATORIES
 

ISOTOPE HALF-LIFE DECAY MODE ENERGY SHIELDING REQUIRED TO DECREASE

EMISSIONS BY A FACTOR OF 10
 
 
 

³H 12.26 yrs. ^- 0.0186 MeV 0
 

¹⁴C 5730 yrs. ^- 0.156 MeV 1 cm plexiglas
 

⁴⁵Ca 165 days ^- 0.252 MeV 1 cm plexiglas
 

³⁵S 87.9 days ^- 0.167 MeV 1 cm plexiglas
 

³²P 14.3 days ^- 1.710 MeV 1 cm plexiglas
 

¹²⁵I 60.2 days 0.035 MeV 0.25 mm Pb
 

¹³¹I 8.05 days ^- 0.086 MeV

0.364 MeV 12.7 mm Pb
 

⁵¹Cr 27.8 days 0.320 MeV 7 mm Pb
 

²²Na 956.3 days ⁺ 1.820 MeV

0.511 MeV 15 mm Pb
 

INVESTIGATOR AUDIT/TRAINING
 

NAME:
 

DATE:
 

LAB ROOM:
 

PROTOCOLS AND TRAINING SHEET
 

CURRENT UPDATE REQUIRED INACTIVE
 
 
 

Employee Training

Record Keeping

Inventories

Use Sheets

Personnel Monitoring

COMMENTS:
 

LAB VISIT:
 

controlled Areas

Security of Radioactivity

COMMENTS:
 

Employee Bioassays - Necessary/Unnecessary
 

Transfers of Radioactivity
 

Waste Generation and Problems
 

Other Problems
 

Personnel in Attendance
 

APPENDIX JJ
 

SI UNITS FOR RADIATION PROTECTION
 

EXPOSURE
 

Roentgen (R), the charge produces in air by or X rays, has the SI unit expressed as coulombs per kilogram (C/kg) of air
 

1 C/kg = 3876 R 1 R = 2.58 X 10^-4C/kg
 

Air Kerma rate, the equivalent of observed dose rate in air, is typically used to define radiation output from sealed sources and has the SI unit grays per second.
 

1 gray (Gy) = 100 rad 1 rad = 0.01 Gy
 

(1 R of X-radiation in the energy range of 0.1 - 3 MeV produces 0.96 rad in tissue.)
 

RADIATION DOSE

The working SI unit is the sievert (Sv) (dose equivalent).
 

1 Sv = 100 rem 1 rem = 0.01 Sv = 10 mSv
 

0.1 µSv 1 µSv 10 µSv 100 µSv

0.01 mrem 0.1 mrem 1 mrem 10 mrem
 

1 mSv 10 mSv 100 mSv 1 Sv

100 mrem 1 rem 10 rem 100 rem
 

Conversion between grays (absorbed dose) and rads is the same as between sieverts and rems, i.e.
 

1 gray (Gy) = 100 rad = 100 roengen
 

Additional Useful Conversions: 7.5 µSv/hr = 0.75 mrem/hr

2 mSv/hr = 200 mrem/hr

30 mSv = 3 rem

500 mSv = 50 rem
 

TRANSPORT INDEX (TI)

TI = (Radiation dose rate in µSv/hr @ 1 meter from package surface) ÷ 10
 

COMMON PREFIXES FOR SI UNITS
 

SUBMULTIPLES MULTIPLES

10^-3 milli m 10³ kilo k

10^-6 micro µ 10⁶ mega M

10^-9 nano n 10⁹ giga G

10^-12 pico p 10¹² tera T
 

SI UNITS FOR RADIOACTIVITY
 

ACTIVITY

The SI unit is the Becquerel (Bq)

1 Bq = 1 disintegration per second = 2.7 X 10^-11 Curie (Ci)

1 Ci = 3.7 X 10¹⁰ Bq = 37 Gbq
 

1 Bq 37 Bq 37 kBq 370 kBq 3.7 MBq 37 MBq

27 pCi 1 nCi 1 µCi 10 µCi 100 µci 1 mCi
 

370 MBq 3.7 GBq 37 GBq 370 GBq 3.7 TBq 37 TBq

10 mCi 100 mCi 1 Ci 10 Ci 100 Ci 1000 Ci

(1 kCi)
 

Some Additional Useful Conversions
 

Curie Units Becquerel Units Curie Units Becquerel Units

µCi kBq µCi MBq

mCi MBq MCi GBq

Ci GBq Ci TBq

0.1 3.7 50 1.85

0.25 9.25 60 2.22

0.5 18.5 100 3.7

0.75 27.75 200 7.4

1 37 250 9.25

2 74 500 18.5

3 111 800 29.6

5 185 1000 37

7 259

10 370

20 740

25 925
 

To convert from one unit to another, read across from one column to the other, ensuring that the units are in the same line of the column heading, i.e.
 

From the above table: From the above table:
 

0.1 mCi = 3.7 MBq 50 mCi = 1.85 GBq

0.1 Ci = 3.7 GBq 3.7 MBq = 100 µCi
 

APPENDIX KK

UNITS AND DEFINITIONS

Absorbed Dose:
 

The energy imparted per unit mass by ionizing radiation to matter at a specified point. The SI unit of absorbed dose is joule per kilogram (J/kg). The special name for this unit is gray (Gy). The previously used special unit of absorbed dose, rad, is being replaced by the gray. 1 rad = 0.01 Gy.

1 Gy = 100 rad.
 

Activity:
 

The number of nuclear transitions occurring in a given quantity of material per unit time. The special name for the unit of activity is becquerel (Bq). The previously used special unit of activity, curie (Ci) is being replaced by the becquerel. 1 Bq = 2.7 X 10^-11Ci. 1 Ci = 3.7 X 10¹⁰ Bq.
 

Airborne Radioactivity Area:
 

A room, enclosure, or area in which airborne radioactive materials, composed wholly or partly of licensed material, exist in concentrations--(1) in excess of the allowed derived air concentrations (DAC's) or (2) 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 0.06% of the annual limit on intake (ALI) or twelve (12) DAC-hours.
 

ALARA:
 

As Low As Reasonably Achievable, economic and social factors being taken into account.
 

Algorithn:
 

A Formula or set of steps for solving a problem.
 

Aluminum equivalent:
 

The thickness of type 1100 aluminum alloy affording the same attenuation, under specified conditions, as the material in question.
 

Aperture:
 

(e.g., for computed tomography) - The opening in the collimation that allows radiation to reach the detector.
 

Attenuation:
 

The reduction of radiation intensity upon passage of radiation through matter.
 

Attenuation block:
 

A block or stack of material with a cross section larger than the beam with a total thickness equivalent to 3.8 cm of type 1100 aluminum.
 

Background Radiation:
 

Radiation arising from sources other than the one directly under consideration. Background radiation due to cosmic rays and natural radioactivity is always present. There may also be additional background radiation due to the presence of sources or radiation in other parts of the building and/or area.
 

Beam Limiting Device:
 

A device which provides a means to restrict the dimensions of the useful beam. In regions outside the beam the device, if an integral partof the radiation-producing equipment, shall provide shielding adequate to meet the leakage requirements of the source assembly to which it is attached.

Becquerel (Bq):
 

The special name for the unit of activity in the SI. 1 Bq = 1 disintegration/second. 3.7 X 10^-10 Bq = 1 Ci.
 

Bent Beam Linear Accelerator:
 

A linear accelerator geometry in which the accelerated electron beam must change direction by 270^o to strike the target.
 

Bioassay (radiobioassay):
 

The determination of kinds, quantities or concentrations, and in some cases, locations of radioactive material in the human body, whether by direct measurement (in vivo counting) or by analysis and evaluation of material excreted or removed from the human body.
 

Biological Half-Time:
 

The time required for a biological system to eliminate, by natural processes, half the amount of a substance (e.g., radioactive material) that has entered it.
 

Centigray:
 

0.01 gray. 1 cGy = 1 rad.
 

Certified Source Assembly:
 

A source assembly certified by an assembler to comply with the leakage reqauirements of the Radiation Control for the Health and Safety Act of 1968.
 

Cinefluorography:
 

The product of motion picture photographic records of the image formed on the output phosphor of and image intensifier by the action of X-rays transmitted through the patient (often called cineradiography).
 

Collimator:
 

Beam limiting device.
 

Collimating Zone:
 

The portion of a therapeutic source assembly that contains the beam limiting device.
 

Computed Tomography:
 

An imaging procedure that uses multiple X-rays trasmission measurements and a computer program to generate tomographic images of the patient.
 

Contact Therapy Aparatus:
 

X-ray therapy apparatus designed for very short treatment distances (SSD of 5 cm or less) usually employing peak tube potentials in the range of 20 to 50 kV.
 

Contamination (radioactive):
 

A radioactive substance dispersed in materials or places where it is undesirable, and particularly in any place where its presence can be harmful.
 

Controlled Area:
 

A defined area in which the occupational exposure of personnel to radiation is under the supervision of the RSO. This area designation is equivalent to a "restricted area."
 

Conversion Factor:
 

(of an image intensifier). The quotient of the luminance of the output phosphor of the image intensifier divided by the kerma rate at the input phosphor.
 

CT Number:
 

One of a set of numbers on a linear scale which are related to the linear attenuation coefficents calculated by a computed tomographic device. One of the specific set of CT numbers on a scale from -1000 to +1000 for bone, with water = 0, which is called a Hounsfield unit.
 

Critical Organ:
 

That part of the body that is most susceptible to radiation damage under the specific conditions considered.
 

Curie:
 

The previouslyused special unit of activity equal to 3.7 X 10¹⁰ per second. 1 Ci = 3.7 X 10¹⁰ Bq.
 

Dead Man Switch:
 

A switch so constructed that a circuit-closing contact can be maintained only by continuous pressure on the switch.
 

Decontamination:
 

The removal of radioactive contaminants from surfaces (e.g., skin) by cleaning and washing.
 

Declared Pregnant Female:
 

A female who has voluntarily informed her employer, in writing, of her pregnancy and the estimated date of conception.
 

Diagnostic Source Assembly:
 

A diagnostic source housing (X-ray tube housing) assembly with a beam limiting device attached. This assembly shall be so constructed that the leakage radiation air kerma measured at a distance of one meter from the source does not exceed 1 mGy (0.1 rad) in one hour when the source is operated at its leakage technique factors.
 

Digital Radiography:
 

A diagnostic procedure using an appropriate radiation source and an imaging system which collects, processes, stores, recalls and presents image information in a digital rather than analog fashion.
 

Digital Subtraction:
 

An imaging processing procedure used to improve image contrast by subtracting one digitized image from another.
 

Dose Equivalent (H):
 

A quantity, defined for radiation protection purposes, which is the product of the absorbed dose to the tissue and a quality factor "Q" determined by the properties of the radiation that produced the absorbed dose. For X-rays, gamma rays and electrons, Q = 1 and dose equivalent values are numerically equal to absorbed dose values when consistent units are used for both quantities. The SI unit for dose equivalent values are numerically equal to absorbed dose values when consistent units are used for both quantities. The SI unit for dose equivalent is sievert (Sv). The previous special unit of dose equivalent, rem, is being replaced by the sievert. 1 Sv = 100 rem.
 

Effective Dose Equivalent (H_E):
 

The sum over specified tissues of the products of the dose equivalent in a tissue (T) and the weighting factor for that tissue (W_T), H_T

= W_TH_T.
 

Effective Half-Life (T_EFF):
 

The time required for a radionuclide contained in a biological system, such as in man, to reduce its activity by half, as a combined result of radioactive decay and biological elimination.
 

Electron Volt (eV):
 

A unit of energy equal to the kinetic energy gained in a vacuum by a particle having one electronic charge when it passes through a potential difference of 1 volt.
 

Elective Examination:
 

An examination not requiring immediate execution and therefor able to be planned for the patient's convenience and safety.
 

Embryo/Fetus:
 

The developing human organism from conception until the time of birth.
 

Exposure (X):
 

A measure of the quantity of x or gamma radiation based upon its ability to ionize air through which it passes. The SI unit of exposure is coulomb per kilogram. The previously used special unit of exposure, roentgen (R), is being phased out. 1 R = 2.58 X 10^-4Ckg^-1 (exactly). The physical quantity exposure is being replaced by the quantity air kerma in air.
 

Film Badge:
 

A pack of appropriate photographic film and filters used to determine radiation exposure.
 

Filter; Filtration:
 

Material in the useful beam which usually absorbs preferentially the less penetrating radiation.
 

Fluorography:
 

The production of a photographic record of the image formed on the output phosphor of an image intensifier by the action of X-rays transmitted through the patient.
 

Focal Spot, Effective:
 

The apparent size of the radiation source region in a source assembly when viewed from the central axis of the useful radiation beam.
 

Framing:
 

In cinefluorography, the registration of the circular image of the output phosphor on the rectangular film element or frame.
 

Geometric Unsharpness:
 

Unsharpness of the recorded image due to the combined optical effect of finite size of the radiation source and geometric separation of the anatomic area of interest from the image receptor and the collimator.
 

Gray (Gy):
 

The special name for the SI unit of absorbed dose, kerma and specific energy

imparted to one joule per kilogram. 1 rad = 0.01 Gy. 1 Gy = 100 rad.
 

Half-Value Layer (HVL):
 

Thickness of a specified substance which, when introduced into the path of a given beam of radiation, reduces the kerma rate by one-half.
 

Heel Effect:
 

Non-uniform intensity observed because a small fraction on the X-ray beam emitted in a direction nearly parallel to the angled target surface must pass through more target material before escaping from the target than does the major portion of the beam which is emitted more perpendicularly. (NOTE: In addition to the non-uniform intensity the angled target also produces non-uniform image resolution due to variation in apparent focal spot size as viewed from various positions on the film).
 

High Radiation Area:
 

An area accessible to individuals, in which radiation levels could result in an individual receiving a dose equivalent in excess of 0.1 rem (1 mSv) in one hour at 30 centimeters from the radiation source or from any surface that the radiation penetrates.
 

Image Intensifier:
 

An X-ray image receptor which increases the brightness of a fluoroscopic image by electronic amplification and image minification.
 

Image Receptor:
 

A system for deriving a diagnostically usable image from the X-rays trasmitted by the patient. Examples: screen-film system; stimulable phosphor; solid state detector.
 

Image Receptor Assembly:
 

An image receptor in a specialized container necessary for proper operation of the receptor.
 

Installation:
 

A radiation source with associated equipment and the space in which it is located.
 

Interlock:
 

A device used to assure proper and safe use of a radiation installation by monitoring (usually by electrical devices) the status, presence or position of various associated devices such a source position, collimator opening, beam direction, door closure, filter presence and preventing the production or emission of radiation if the potential for an unsafe condition is detected.
 

Kerma:
 

The sum of the initial kinetic energies of all the charged ionizing particles liberated by uncharged ionizing particles per unit mass of a specified material. Kerma is measured in the same unit as absorbed dose. The SI unit of kerma is joule per kilogram and its special name is gray (Gy). Kerma can be quoted for any specified material at a point in free space or in an absorbing medium.
 

Kilovolt (kV):
 

A unit of electrical potential difference equal to 1000 volts.
 

Lead Equivalent:
 

The thickness of lead affording the same attenuation, under specified conditions, as the material in question.
 

Leakage Technique Factors:
 

These are specific technique factors (associated with specific source assemblies) which are used in measuring leakage radiation. They are defined as follows:
 

(1) For diagnostic source assemblies (qv)
 

(a) for capacitor enery storage equipment, the maximum rated kV and the maximum rated number of exposures in an hour at the maximum rated kV with the mAs being the greater of 10 mAs or the minimum mAs (allows greatest exposure in an hour) available.
 

(b) for field emission equipment rated for pulsed operation, the maximum rated number of pulses in an hour at the maximum kVp.
 

(c) for all other types of equipment, the maximum rated kVp and the maximum rated continous tube current for the maximum kV.
 

(2) For therapeutic source assemblies (qv) for X-ray production at tube potentials below 500 kV, the maximum rated continuous tube current for the maximum kV.
 

(3) For therapeutic source assemblies for X-ray production at tube potentials of 500 kV and above and for gamma source assemblies, see therapeutic source assemblies.
 

Magnification Imaging:
 

An imaging procedure carried out with magnification usually produced by purposeful introduction of distance between the subject and the image receptor.
 

Mega Electron Volts (MeV):
 

Energy equal to that acquired by a particle with one electron charge in passing through a potential difference of one million volts (one MV) in a vacuum.
 
 
 

Modulation Transfer Function (MTF):
 

A mathematical entity that expresses the relative response of an imaging system or system conponent to sinusoidal imputs as a function of varying spatial frequency, which is often expressed in line pairs per millimeter (lp/mm). The reference value most commonly used is that for zero frequency. The MTF can be though of as a measure of spatial resolution of the detector system.
 
 
 

Noncontrolled Area:
 

Any space not meeting the deinition of a controlled area. This area designation is equivalent to an unrestricted area.
 

Nonstochastic Effects:
 

Effects for which the severity of the effect in affected individuals varies with the dose, and for which a threshold usually exists.
 

Nuclide:
 

A general term applicable to all atomic forms of elements. The term is often erroneously used as a synonym for "isotope" which properly has a more limited definition. Whereas isotopes are the various forms of a single element (hence are a family of nuclides) and all have the same atomic members, nuclides comprise all the isotopic forms of all the elements.
 

Occupancy Factor (T):
 

The factor by which the workload should be multiplied to correct for the degree of occupancy (by any one person) of the area in question while the source is in the "ON" condition and emitting radiation. This multiplication is carried out for radiation protection purposes to determine compliance with the dose equivalent limits.
 

Operator:
 

Any individual who personally utilizes or manipulates a source of radiation.
 

Personnel Monitor:
 

Also known as personal monitor. An appropriately sinsitive device used to estimate the absorbed dose received by an individual.
 

Phantom:
 

An object used to simulate the absorption and scatter characteristics of the patient's body for radiation measurement purposes.
 

Physical Half-Life:
 

The time required for a radioactive substance to lose 50% of its activity by decay; radioactive half-life.
 

Pixel:
 

A two-dimensional picture element in the presented image.
 

Protective Apron or Glove:
 

An apron or glove made of radiation absorbing material, used to reduce radiation exposure.
 

Protective Barrier:
 

A barrier of radiation absorbing material(s) used to reduce radiation exposure.
 

Primary Protective Barriers attenuate the useful beam for radiation (scattered plus leakage) protection purposed.
 

Secondary Protective Barriers attenuate stray radiation (scattered plus leakage) for protection purposes.
 

Protective Source Housing:
 

An enclosure, for a gamma-beam therapy source, so constructed that the leakage radiation does not exceed specified limits.
 

Quantum Mottle:
 

The variation in optical density, brightness, CT number or other appropriate parameter in an image which results from the random spatial distribution of the X-ray or light quanta absorbed at the stage of the imaging chain containing the minimum information content. This stage is known as the quantum sink.
 

Rad:
 

The previously used special unit of absorbed dose. It is equal to 100 ergs per gram. 1 rad = 0.01 Gy.
 

Radiation:
 

Any electromagnetic or particulate radiation capable of producing ions, directly or indirectly, by interaction with matter. Examples are X-ray photons, charged atomic particles and other ions and neutrons.
 

Leakage Radiation:
 

All radiation coming from within the source assembly except for the useful beam.
 

Scattered Radiation:
 

Radiation that, during passage through matter is changed in direction. (It is usually accompanied by a decrease in energy).
 

Stray Radiation:
 

The sum of leakage and scattered radiation.
 

Useful Beam:
 

The radiation which passes through the opening in the beam limiting device and which is used for imaging or treatment.
 

Radiation Protection Survey:
 

An evaluation of the radiation safety in and around an installation, that includes radiation measurements, inspections, evaluations and recommendations.
 

Radiation Receptor:
 

Any device that absorbs a portion of the incident radiation energy and converts this portion into another form of energy which can be more easily used to produce desired results.
 

Radiograph:
 

A film or other record produced by the action of X-rays on a sensitized surface.
 

Radiography:
 

The production of images on film by the action of X-rays transmitted through the patient.
 

Rem:
 

The previously used special unit of dose equivalent. One rem equals 10^-2 Sv.
 

Resolution:
 

In the context of an image system, the output of which is finally viewed by the eye, it refers to the smallest size or highest spatial frequency of an object of given contrast that is just perceptible. The intrinsic resolution, or resolving power, of an imaging system is measured in line pairs per millimeter (lp/mm), ordinarily using a resolving power target. The resolution actually achieved when imaging lower contrast objects is normally much less, and depends upon many variables such as subject contrast levels and noise of the overall imaging system.
 

Roentgen (R):
 

The previously used special unit of exposure. An exposure of one R will produce 2.58 X10^-4 C of ions of either sign per kilogram of air. In this report, the previously used physical quantity exposure has been replaced by kerma in air. 1 R does not equal 1 cGy as the units C/kg and J/kg are different. The numerical value of kerma in cGy may be substituted for the numerical value of exposure in R.
 
 
 

Sealed Source:
 

A radioactive source sealed in a container or having bonded cover, in which the container or cover has sufficient mechanical strength to prevent contact with or dispersion of the radioactive material under the conditions of use for which it was designed.
 

Serial Radiography:
 

A radiographic procedure in which a sequence of radiographs is made rapidly by using an automatic cassette changer, image intensifier TV, etc.
 

Shutter:
 

In beam therapy equipment, a device, attached to the X-ray or gamma-ray source housing to control the "ON" or "OFF" condition of the useful beam.
 

Sievert (Sv):
 

The special name for the SI unit of dose equivalent. 1 Sv = 1 J/kg. 1 Sv = 100 rem.
 

Signal-to-Noise Radio:
 

For video cameras, the radio of input signal to background interference. The greater the ratio, the clearer the image.
 

Simulator:
 

Diagnostic energy X-ray equipment used to simulate a therapy treatment plan outside the treatment room.
 

Slice:
 

The single body section imaged in a tomography procedure.
 
 
 

Source-to-Distance (SID):
 

The distance measured along the central ray from the center of the front of the surface of the source (X-ray focal spot or sealed radioactive source) to the surface of the image detector.
 

Spot Film:
 

A radiograph taken during a fluoroscopic examination for the prupose of providing a permanent recored of an area of interest or to verify the filling of a void with contrast media.
 

Stochastic Effects:
 

Effects, thr probability of which, rather than the severity, is a function of the radiation dose without threshold. (More generally, stochastic means random in nature).
 

Target:
 

The part of an x-ray tube anode assembly impacted by the electron beam to produce the useful x-ray beam.
 

Tenth Value Layer (TVL):
 

Thickness of a specified substance which, when intoduced into the path of a given beam of radiation, reduces the kerma rate to one-tenth of its original rate.
 

Therapeutic Source Assembly:
 

A therapeutic source housing assembly for x-ray and electron beam production with a therapeutic beam-limiting device attached. These assemblies shall be constructed to meet the leakage requirements for the specified leakage technique factors indicated.
 

(1) For x-ray production at tube potentials from 5-50 kV, the leakage kerma rate at any position 5 cm from the assembly, shall not exceed 0.1 cGy (0.1 rad) in any one hour.
 

(2) For x-ray production at tube potentials greater than 50 kV and less than 500 kV, the leakage kerma rate measured at a distance of 1 m from the source in any direction shall not exceed 1 cGy (1 rad) in any one hour when the source is operated at its leakage technique factors. In addition, these assemblies shall limit the kerma rate at a distance of 5 cm from the surface of the assembly to 30 cGy (30 rad) in any one hour.
 

(3) For x-ray and electron beam production above 800 kV, the assembly shall be designed so that the following conditions are fulfilled for the regions outside the useful beam. The absorbed dose rate due to leakage radiation (excluding that from neutrons) at any point outside the maximum sized useful beam but within a circular plane of radius 2 m which is perpendicular to and centered on the central axis of the useful beam at the normal treatment distance, shall not exceed 0.2% of the absorbed dose rate to tissue on the central axis of the treatment distance.
 

Tomography:
 

A special technique to show in detail images of structures lying in a predetermined plane of tissue, while blurring or eliminating detail in images of structures in other planes.
 

Use Factor (U):
 

Fraction of the workload during which the useful beam is directed at the barrier under consideration.
 

User:
 

Physicians and others reponsible for the radiation exposure of patients.
 

Voxel:
 

A volume element in the object being imaged. The mean attenuation cefficient of the voxel determines the CT (Hounsfield) number of the pixel.
 

Whole Body Dose Equivalent (H_WB):
 

The dose equivalent associated with the uniform irradiation of the whole body.
 

Workload (W):
 

The degree of use of a radiation source. For x-ray machines operating at tube potentials below 500 kV, W is usually expressed in mA-min/week. For gamma-beam therapy sources and for photon-emitting equipment operatinng at 500 kV or above, W is usually stated in terms of the weekly kerma of the useful beam at 1 m from the source and is expressed in Gy/week at 1 m.
 

APPENDIX LL
 

MANAGEMENT OF VICTIMS OF RADIOACTIVE CONTAMINATION
 

A. Purpose
 

To outline a plan of action for meeting the basic requirements of Tulane University Medical Center's role in an external disaster situation resulting in casualties who are suspected or known to have become contaminated with transferable radioactive material, either by ingestion, deposition on skin or entering through open wounds.
 

B. Objectives
 

1. To handle radiation casualties.
 

2. To treat and service radiation casualties by applying the best medical standards.
 

3. To accomplish the above while avoiding or minimizing radiation exposure to hospital personnel and patients.
 

4. To accomplish the above while continuing usual hospital functions.
 

5. To integrate the specialized supplies and experienced radiation safety personnel into hospital routine.
 

C. Notification of Disaster
 

1. Any person receiving information of a disaster resulting in radiation casualties should immediately relay such information to the Emergency Room Physician. The Emergency Room Physician is responsible for attempting to obtain the following information:
 

a. Name of person calling and their phone number.
 

b. Location and type of accident.
 

c. Type and amount of radiation involved.
 

d. Number of victims.
 

e. Extent of injuries.
 

f. Type of transportation available or requested.
 

g. Expected arrival time.
 

2. Upon verification of a nuclear accident The Emergency Room Physician shall notify the RSO.
 

Charles F. Reindl, M.S.

Office: 584-2867

Home: 837-8516
 

Deputy RSO: Michael T. Gauthier, B.S.

Office: 584-2878

Home: 738-2240
 

3. The RSO will notify the Radiation Protection Division and shall contact local police authorities to verify the disaster and obtain additional information.
 

4. Upon verification of the nature and extent of the disaster, the Emergency Room Nurse in conjunction with the Emergency Room Physician will evaluate the situation and make the decision whether to implement the Radiation Disaster Plan.
 

5. Upon Implementation of the Radiation Disaster Plan, the Emergency Room Nurse will notify:
 

* Administrator On Call
 

* Nursing Supervisor (Off Shifts)
 

* TUMC Police
 

* Environmental Services
 

* Public Relations
 

6. Emergency Department Personnel will Set up the Radiation Emergency Area (REA).
 

7. The Emergency Department Triage Nurse, with the aid of TUMC Police, will evacuate occupants of the Waiting Areas and lock the door until the Emergency has been declared over.
 

D. Pre-Emergency Planning
 

1. The Emergency Room Nurses will evaluate the status of the patients present and work with the physicians to discharge as many as possible. All pregnant or possibly pregnant women should be moved to other areas of the hospital.
 

2. Pre-hospital communications between the ambulance and Emergency Room Physician will establish the extent of trauma injuries and level of contamination. Decision will be made by the RSO, Emergency Room Charge Nurse or the Emergency Room Physician whether to direct patients to the Radiation Emergency Area (REA) or the decontamination area in the Emergency Department.
 

3. The Radiation Emergency Area (REA) will be established in the following manner:
 

a. Emergency Rooms 6 and 7 become the Treatment Rooms and the Adjacent Offices become the Decontamination Rooms.
 

b. Assist in removal of non-essential items from REA. If unable to remove any item, it should be covered with plastic.
 

c. Contact Central Supply to assure that all decontamination room supplies are in the Emergency Room area as appropriate.
 

d. Assist radiation safety personnel in setting up the Monitoring/Control Station(s).
 

e. Assist in roping off/closing off REA and posting "Caution, Radiation Area" signs.
 

f. Cover flooring in REA rooms and route (from entrance by transporting vehicle into REA) with paper, securing cover to flooring with tape.
 

4. The Assistant Director of Nursing in coordination with Emergency Room Charge Nurse shall designate nurses to be assigned to REA and person to be assigned outside REA to obtain extra supplies as needed.
 

5. The RSO shall designate person(s) to man Control Points and shall check all radiation monitoring equipment to insure it is in working order.
 

6. Safety and TUMC Police will be responsible for insuring all doors are opened in the receiving route of REA, assisting with roping off REA area and insuring area is free from by-standers and nonessential equipment.
 

7. Public Relations/Nursing House Supervisor will be responsible for all press releases which have been reviewed for technical content and approved prior to issue by the physicians and/or RSO.
 

E. Radiation/decontamination Team
 

1. Physicians
 

a. Emergency Room Physicians shall be in charge of medical problems.
 

b. The RSO shall be in charge of directing decontamination procedure.
 

c. "RADIATION ACCIDENT PATIENT FORM" shall be employed.
 

2. Emergency Room Personnel (minimum of 4)
 

a. Two to assist physicians with patient.
 

b. One Nursing Assistant to be in REA to receive supplies from outside REA and record treatment.
 

c. One Nursing Assistant to be outside REA to obtain supplies, as needed.
 

3. Radiation Safety Personnel
 

a. RSO/Deputy RSO.
 

b. Director, Radiology/Nuclear Medicine for assistance in monitoring areas and personnel, responsible for analysis of radioactive content of swabs, samples, etc.
 

F. Receiving Procedures
 

1. Persons suspected of being contaminated with radionuclides will be received at the Emergency Department.
 

2. Radiation/Decontamination Team (Physicians, Nurses and radiation safety personnel) meeting the transporting vehicle will be attired as follows:
 

a. Double Surgical scrub suits, gowns, surgical caps, mask and shoe covers (tape outside of scrub suits over top shoe covers and remember to remove all jewelry).
 

b. Surgical gloves (tape gloves to sleeves of gown).
 

c. Surgical gloves (second pair) - do not tape and change as needed if torn or contaminated.
 

d. Pocket dosimeters will be worn at neck region where they can be easily removed by other persons for monitoring. They should be read at intervals during decontamination and reported to the control point attendant.
 

3. The patient will be met at transporting vehicle with a stretcher draped with a plastic sheet.
 

4. The physician will evaluate the patient to determine if there is any medical problem or associated injury requiring care prior to decontamination.
 

5. If not, the patient shall be wrapped in plastic and transported to a designated shower for decontamination.
 

6. The RSO or Deputy shall monitor the patient and log all contaminated areas with location and exposure measurement on chart provided.
 

7. All patient clothing shall be removed and placed in plastic bags labeled "patient's clothing". Valuables shall be bagged and labeled with patient information. The RSO will be responsible for disposition of clothing and valuables
 

8. The Emergency Room Physician will proceed with required critical patient care and evaluation. The RSO will collect swab samples for radiation safety personnel to monitor. These samples should include samples of ear canals, nostrils, scalp, fingernails, toenails, mouth and contaminated areas of body, etc. All samples are to be placed in separate containers labeled with patient's name, area and time obtained. Duplicate swab samples shall be saved for the Division of Radiological Health.
 

9. Physicians shall proceed with decontamination of radioactive areas (OPEN WOUNDS FIRST PRIORITY).
 

10. The patient shall shower and lightly scrub all contaminated areas with betadine prep without breaking the skin.
 

11. The RSO will again monitor following decontamination and log dose and, if necessary, repeat the shower and scrub procedure.
 

12. After decontamination, the patient may be admitted to a regular hospital bed. If the patient has inhaled or ingested radionuclides, he should be placed in a private room. All urine and feces shall be saved for monitoring. Radiation signs shall be placed on room door.
 

13. The transporting vehicle and personnel will be notified by the RSO to REMAIN WITH THE VEHICLE until monitored and released or instructed by the RSO concerning decontamination.
 

14. The Deputy RSO shall survey the ambulance and Emergency Medical Service (EMS) personnel prior to their release to duty. Decontamination procedures according to "Decontamination Procedures" will be performed at the direction of the RSO.
 

15. Area entrances and hallways will be monitored by the Deputy RSO after patient is located in Radiation Emergency Area so as to prevent tracking to other hospital areas.
 

G. Monitoring/Control Point Functions
 

1. The RSO shall designate Safety and TUMC Police Staff Members to function as control point attendants.
 

2. The attendants shall be responsible for:
 

a. Restricting access to only personnel authorized by the attending physician, RSO or Nursing Supervisor.
 

b. Assure that above personnel are wearing protective clothing and proper monitoring devices.
 

c. Maintain a record showing name of person entering, dosimeter number, time of ingress from REA.
 

d. Assure that no person or object is allowed to leave REA (after patient admitted) until monitoring has been performed and there is no detectable radionuclide contamination.
 

H. Radiation Emergency Area (REA)
 

1. The REA will consist of the Receiving Route, Emergency Room.
 

2. The Monitoring/Control Points will be established in corridors, outside Emergency Room.
 

3. All attending personnel will wear protective clothing and a pocket dosimeter.

4. Attending personnel will remove protective clothing and place in plastic bag labeled contaminated linen and trash before leaving REA.
 

5. All personnel will be monitored at Central Point before leaving area.
 

6. No supplies, clothing, etc., will leave the area until monitored.
 

7. The REA will remain closed to all personnel until it has been determined to be free of radioactive contamination by personnel trained in use of monitoring equipment.
 

8. The RSO or Deputy RSO will dictate need for masks, respirators, as well as need to shut off air supply and vents to avoid airborne contamination by notifying the Maintenance Department.
 

9. Those individuals performing actual decontamination with water should wear plastic or rubber aprons.
 

10. Disposal of all radioactive material will be supervised by radiation safety personnel.
 

I. Procedures for Transfer of Patient
 

1. Following decontamination and emergency treatment, the patient may be transferred from the REA to the appropriate section of the hospital.
 

J. Extreme Medical Emergency Requiring Immediate Surgery
 

1. In the event of the above circumstances, the patient will be wrapped in plastic sheet to prevent spread of contamination and taken directly to the Operating Room on an uncontaminated stretcher accompanied by the RSO or Deputy RSO.
 

2. If time permits, the patient should be surveyed to locate and mark off contaminated areas.
 

3. The Operating Room personnel will be notified of contaminated patient by the RSO.
 

4. All articles and specimens removed must be saved for radioassay.
 

5. The Operating Room becomes a part of the REA and no personnel or objects may be removed from the area unless monitored and found to be free of contamination.
 

6. Removal of patient following surgery and decontamination will be under supervision of RSO or Deputy RSO in coordination with attending physician.
 

K. Exit of Decontamination Team
 

1. Each team member goes to clean line where control point attendant is located and removes protective clothing (placing all of it in a plastic bag marked contaminated linen and trash).
 

a. Remove outer gloves first, turning them inside out as they are pulled off.
 

b. Give dosimeters to RSO or Deputy.
 

c. Remove all tape at trouser cuffs and sleeves.
 

d. Remove outer surgical gown, turning it inside out; avoid shaking.
 

e. Remove surgical shirt.
 

f. Remove head cover.
 
 
 

g. Pull surgical trousers off over shoe covers.
 

h. Remove all outer garments.
 

i. Provide a pathway of stretcher paper from morgue to employee locker room at rear (employee) entrance.
 

j. Take shower.
 

L. RSO/Deputy RSO responsibilities
 

1. Supervise radiation protection at the hospital.
 

2. Designate persons to man Control Points.
 

3. Check all radiation monitoring equipment to insure proper working order.
 

4. Monitor patient and decontamination team during care of patient.
 

5. Monitor transport vehicle and personnel before they leave area.
 

6. Monitor route from transport vehicle to REA and decontamination of above, if necessary.
 

7. Analyze all specimens for radiation content.
 

8. Collect dosimeters, monitor and evaluate personnel throughout the emergency.
 

9. Assist in the decontamination of patient when treatment of injury permits, as determined by attending physician.
 

10. Collect used protective clothing, wastes, samples and equipment for decontamination, evaluation and/or disposal.
 

11. Record radiation survey findings of personnel and property, evaluate and recommend follow-up as necessary.
 

12. Inspect decontamination supply stored in Radiation Disaster cart located in Central Supply to assure appropriate stocking levels and freshness of dated articles.
 

M. Emergency Room Physician Responsibilities
 

1. Evaluate and treat the patient's critical medical problems and then proceed to decontamination.
 

N. Safety and TUMC Police Responsibilities
 

1. Restricts access to only authorized personnel.
 

2. Assures that all persons working in REA are wearing protective clothing and personal monitoring devices.
 

3. Maintains a record indicating name of person, dosimeter number, dosimeter reading and time of ingress and egress from REA.
 

4. Allows no individual or object to leave unless free of contamination.
 

5. Makes sure that all doors are opened in the receiving route of REA and elevators are available, if needed.
 

6. Assists with roping off REA area and insuring area remains free of unauthorized persons.
 

O. Public Relations Responsibilities
 

1. Provide all press releases after consulting with physicians, Nursing Supervisor and/or RSO.

P. Environmental Services Responsibilies
 

1. Environmental Services Supervising personnel shall be available to obtain additional supplies, when requested.
 

2. Cleans REA under direction of RSO or Deputy RSO.
 

Q. Emergency Department Charge Nurse Responsibilities
 

1. Work with physician to discharge as many Emergency Room patients as possible or move them out of the REA.
 

2. Supervise the set up of the REA.
 

3. Work with the Nursing Supervisor to arrange for at least four nursing personnel to assist.
 

R. Nurse Working Within REA Responsibilities
 

1. Work directly with the physician in delivering care to the patient.
 

2. Collects specimen samples, washes contaminated areas, etc.
 

S. Nursing Assistants Within REA Responsibilities
 

1. Requests and receives supplies from outside the REA.
 

2. Records information regarding care for patient's chart.
 

3. Labels properly any samples obtained.
 

T. Emergency Department Personnel Outside REA Responsibilities
 

1. Obtain any supplies or equipment needed.
 

2. Supply medications as needed.
 

U. Final Survey REA
 

1. The RSO and Deputy RSO shall perform a radiation survey of the REA to confirm all areas, furniture, instruments and supplies are safe and contamination free.
 

RADIATION EMERGENCY AREA PLAN

RADIATION DISASTER PLAN CRITICAL PERSONNEL
 
 
 

1. Medical Director of Radiology/Nuclear Medicine:
 

Name: Richard Campeau, M.D.
 

Work: 587-7567
 

Home: 866-6158
 

2. Radiation Safety Officer:
 

Name: Charles F. Reindl, M.S.
 

Work: 548-2867
 

Home: 837-8516
 

3. Medical Director, Emergency Room:
 

Name: Norman McSwain, M.D.
 

Work: 588-5111
 

Home: 949-9822
 

4. Deputy Radiation Safety Officer
 

Name: Michael T. Gauthier, B.S.
 

Work: 584-2878
 

Home: 738-2240
 

5. Security
 

Name: Lawrence E. Cooper
 

Work: 588-5532
 

Home: 737-8413
 

6. Safety Officer
 

Name: Louis Mayer, MPH
 

Work: 588-5486
 

Home: 241-5119
 

RADIATION ACCIDENT PATIENT FORM

Full name: Social Security Number:
 

Birth Date: Age: Sex: Race
 

Current local address:
 

Current permanent address:
 

Father's name: Mother's name
 

Women only: Date of last menstrual period: No. of pregnancies:
 

No. of miscarriages:
 

Could you be pregnant now? Definitely yes: Definitely no: Not Sure:
 

If you are pregnant, estimated delivery date:
 

Any problems with the pregnancy:
 

PAST HISTORY:
 

Any known treatment with X-rays or Isotopes?
 

If so, reason for treatment:
 

Month/year of treatment:
 

Place where treatment was given:
 

Have you ever had any cancer or other malignancy?
 

If yes, type:
 

Date of diagnosis:
 

FAMILY HISTORY:
 

How many children do you have? Are they all healthy?
 

Indicate which, if any, of the following malignancies are present in one or more members of your family:
 

Leukemia Breast Thyroid Lung Stomach Intestines Bone
 

Current Medications:
 

Allergies:
 

DETAILS OF RADIATION ACCIDENT:
 

Location where accident occurred:
 

Time and date of exposure:
 

Type of radiation source:
 

Location of accident victim:
 

Distance from source:
 

Duration of exposure:
 

Shielding, including buildings, clothing, etc.
 

Dosimetry: Estimated Radiation Doses (whole body and organ specific
 
 
 
 

Name, title, and address of individuals who estimated doses:
 
 
 
 
 
 
 

Method of dose estimate: Historical Dosimeters Other
 

Immediate post-accident medical assessment:
 

Time: Date: Location:
 

Symptoms:
 

Physical findings:
 

Laboratory Data, including pregnancy test in all women who might be pregnant:
 
 
 
 

Disposition of patient:
 

NAME/ADDRESS OF FAMILY PHYSICIAN:
 

NAME/TITLE OF PERSON COMPLETING THE FORM:
 

CONDENSED RESEARCH LABORATORY RULES

A. Laboratories with regular use patterns shall perform daily surveys of their immediate work areas with an end window or scintillation type radiation survey meter. Surveys for the presence of radioactive contamination must be performed on a weekly basis AND DOCUMENTED so that they can be inspected by regulatory authorities. Occasional use laboratories must perform and record these checks at the completion of each procedure.
 

B. Decontamination of work areas must be performed when contamination levels exceed twice background.
 

C. Accurate Radionuclide Receipt and Use Records must be maintained in order to verify that radioactive material has been used and disposed of in a safe and legal manner.
 

D. A Semi-Annual Radionuclide Inventory/Sewer Disposal form is required of each licensee every six months.
 

E. No food or drink can be stored in refrigerator/freezers that are used to store radioactive materials.
 

F. Incoming radioactive material packages labelled White I, Yellow II, or Yellow III must be wipe tested for radioactive contamination and the results recorded.
 

G. Radioactive labels on empty radioactive shipping packages must be removed/defaced prior to disposal.
 

H. Radioactive waste is accepted in Room 1105 of the Medical School, Tuesday and Thursday from 8:30 to 10:30 a.m.

 

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