License Application for Radiation Sciences, School of Nuclear Medicine

Purpose
The use of by-product material will be used strictly for the training of nuclear medicine students with teaching occurring in the areas of radiopharmacy and instrumentation.  It should be noted that radioactive material(s) will not be used in humans or animals. 

Location
All laboratory procedures will be done in 2133 located at 701 West Grace Street.  Map of this room has been provided.

Additionally, the use of by-product materials will occur during specific times of the year and will be utilized in the following courses:  CLRS 321, 344, 461, and CLRZ 328L.

In your case, make up an address.

Type of License
See 10.8 - Is it general or specific?

Authorized Personnel - While 10.8 discusses training and responsibility for ALARA, consider who is in charge and responsible for the running of the department. Define an RSO. Note the role/relationship of the Physician. Where does the doctor fall into in the area of responsibility?

Program Director will be authorized user and he/she will be assisted by Clinical Coordinator in the NMT program.  These individuals are responsible for the use of all by-product materials within the Nuclear Medicine Laboratory (Room 2133).  Students will be under constant supervision when performing or in the handling of radioactive materials.  Furthermore, authorized personnel will be certified nuclear medicine technologist (CNMT and/or RT (N)) who have undergone specific competencies and training in the use of by-product materials which pertains to nuclear medicine.  These individuals will be approved by VCU’s Office of Environmental Health and Safety, Radiation Safety Section.

Facilities and Equipment
There will be only one room designated for the training of students in the use of by-product material, as noted above.

Lead shielding is used in the follow manner:  door, storage cabinet (were sources, generator, and waste is stored) syringe container, syringe shields, syringe vials, L-block, and lead bricks.

Forceps and gloves will be used to handle radioactive sources.

Absorbent paper will be used areas where unsealed sources are being utilized. 

Calibration of Survey Equipment
Calibration of survey equipment will be completed by the Radiation Safety Section at VCU and will be done annually.

Dose Calibrator Calibration QC -Appendix C - See all Appendices


1.

QC of the dose calibrator will occur as a laboratory procedure, observed and evaluated by authorized personnel, and documented.  Acceptable ranges for each procedures are as follows:

a.

Constancy at least once each day prior to use (+/-10 percent).

b.

Linearity at installation and every quarterly thereafter (+/- 10 percent).

c.

Geometry dependence at installation (+/- 10 percent).

d.

Accuracy at installation and at least annually thereafter (+5 percent).

2.

After repair, adjustment, or relocation of the dose calibrator, the repeat the above tests as appropriate.

Personnel Monitor Program
This program will adhere to the policies stated by the Radiation Safety’s Section at Virginia Commonwealth University.

Radiation Safety Program
This program will be adhere to the policies stated by the Radiation Safety’s Section at Virginia Commonwealth University.

Leak Test - Appendix H
This procedure is completed on a semi-annual bases by Radiation Safety’s Section at Virginia Commonwealth University.

Rules for Safe Use of Radiopharmaceuticals - Appendix I


1.

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

2.

Wear disposable gloves at all times while handling radioactive materials.

3.

Either after each procedure or before leaving the area, monitor hands will be monitored for contamination in a low-background area with a survey meter.

4.

Use syringe shields for routine preparation of multi-dose vials, except in those circumstances in which their use is contraindicated.

5.

There will be no eating, drinking, smoking, or applying of cosmetics in any laboratory where radioactive material is stored or used.

6.

No storage of food, drink, or personal effects in areas where radioactive material is stored or used.

7.

Personnel monitoring devices will be wore at all times whenever radioactive materials is used or stored. These devices should be worn as prescribed by the Radiation Safety Officer.

8.

Finger monitor exposure devices will be used during elution of generators; during the preparation, assay, and QC testing of radiopharmaceuticals.

9.

Dispose of radioactive waste will only occur in designated, labeled, and in properly shielded receptacles.

10.

Pipetting will never be done by mouth.

11.

Wipe-test will occur weekly in areas where byproduct material is stored, prepared, and labs are preformed to determine if there is any removable contamination. If necessary, decontaminate or secure the area for decay will be done if the amount is greater than 2200 dpm/cm2.  During times in which the lab is not be used by students weekly wipe testing will not be done.

12.

On a daily bases area survey will be completed in generator storage, kit preparation, and dose calibrator areas to determine if there is any contamination. If necessary, decontaminate or secure the area for decay will be done if the area is greater than 1 rm/hr.

13.

Radioactive solutions will be shielded in lead containers and clearly labeled. Radiopharmaceutical multi-dose diagnostic vials will be labeled with the isotope, the name of the compound, and the date and time of receipt or preparation. A log book will be used to record the preceding information and total prepared activity, specific activity as mCi/cc at a specified time, total volume prepared, total volume remaining, the measured activity of unit dose (not be injected in patients or animals), and any other appropriate information. Syringes and unit dosages will be labeled with the radiopharmaceutical name or abbreviation or type of study.

14.

Radioactive doses will be assayed in the dose calibrator before. The amount of activity that adheres to the syringe wall or remains in the needle will be considered.

15.

The following will always be shielded: flood sources, syringes, waste, sealed sources, and other radioactive materials.

Spill Procedure - Appendix J Major and Minor
Minor Spills of Liquids and Solids


1.

Notify persons in the area that a spill has occurred.

2.

Prevent the spread of contamination by covering the spill with absorbent paper.

3.

Clean up the spill using disposable gloves and absorbent paper. Carefully fold the absorbent paper with the clean side out and place in a plastic bag for transfer to a radioactive waste container. Also put contaminated gloves and any other contaminated disposable material in the bag.

4.

Survey the area with a low-range radiation detector survey meter. Check the area around the spill. Also check your hands, clothing, and shoes for contamination.

5.

Report the incident to the Radiation Safety Officer (RSO).

6.

The RSO will follow up on the cleanup of the spill and will complete the Radioactive Spill Report and the Radioactive Spill Contamination Survey.  Report and survey are available at the Radiation Safety Section.

Major Spills of Liquids and Solids


1.

Clear the area. Notify all persons not involved in the spill to vacate the room.

2.

Prevent the spread of contamination by covering the spill with absorbent paper, but do not attempt to clean it up. To prevent the spread of contamination, limit the movement of all personnel who may be contaminated.

3.

Shield the source if possible. This should be done only if it can be done without further contamination or a significant increase in radiation exposure.

4.

Close the room and lock or otherwise secure the area to prevent entry.

5.

Notify the RSO immediately.

6.

Decontaminate personnel by removing contaminated clothing and flushing contaminated skin with lukewarm water and then washing with mild soap. If contamination remains, induce perspiration by covering the area with plastic. Then wash the affected area again to remove any contamination that was released by the perspiration.

7.

The RSO will supervise the cleanup of the spill and will complete the Radioactive Spill Report and the Radioactive Spill Contamination Survey.  Report and survey are available at the Radiation Safety Section.

Ordering and Receiving of Radioactive Packages - Appendix K


1.

The Radiation Safety Officer (RSO) or a designee must authorize each order for radioactive materials and ensure that the requested materials and quantities are authorized by the license for use by the requesting authorized user and that possession limits are not exceeded.

2.

The RSO will establish and maintain a system for ordering and receiving radioactive material. The system must contain the following information:

 

a.

For routinely used materials

 

 

(1)

Written records that identify the authorized user or department, isotope, chemical form, activity, and supplier will be made.

 

 

(2)

The above records will be checked to confirm that material received was ordered through proper channels.

 

b.

Therapeutic dosages will not be ordered for student training

3.

For deliveries during normal working hours will all go to room 2133.  If the program director or clinical coordinator is/are not on sight, then another individual trained in basic radiation safety will follow and instruct the delivery person to place the package in room 2133. 

4.

There will be no off-duty delivery hours.   

Procedures for Receiving and Opening Radioactive Packages - Appendix L

  1. A radiation survey of the external surfaces of a package will be performed unless the package contains quantities of radioactive material less than or equal to the Type A quantity (10CFR 20.1906(b)(2)).
  2. Any package, regardless of the quantity of radioactivity, which has evidence of potential contamination, such as packages that are crushed, wet or damaged, must be surveyed.

Wipe testing of radioactive packages:

  1. A wipe test of the external surfaces of a package will be completed unless the package contains only radioactive material in the form of a gas or in special form (10CFR 20.1906(b)(1)).
  2. Any package, regardless of the quantity of radioactivity, which  has evidence of potential contamination, such as packages that are crushed, wet or damaged, must be wipe tested. Below is an example of an imaging area with hot lab

     

Example Map

Time constraints:

  1. Any required wipe testing or radiation surveying of radioactive materials packages will be done as soon as possible after receipt of the package, but no later than three hours after the package.

Notification of incidents:

The NRC, RSO and the final delivery carrier will be notified immediately by telephone or fax if the removable surface contamination from any package exceeds 0.001 uCi (2200 dpm) per 100 square centimeters.

Comment on receiving Unit Doses - Appendix M.1.

Control of Radioactive Material and Posting Requirements

Radioactive material in storage will be secured at all times. In addition, when radioactive material that is not under lock and key it will be under constant surveillance.

A "Caution, Radiation Area" warning sign must be posted at the entrance to room 2133. 

Radioactive Waste Disposal - Appendix R

All radioactive waste will be disposed of by decay in storage.

When replacement of a sealed source is required it will be purchased and the older source will be returned to the manufacturer.

Records - Appendix M

A records related to radiation protection program, radiation surveys, personnel doses, overexposures, and waste disposal be maintained by the NMT program.

Located in 10 CRF 20 SubPart L

Area Survey and "Removable Contamination Survey (wipe testing) - Appendix N

Draw a map identifying the following: injection area/treadmill, hot lab, and imaging area. Were and when do you do your area surveys? What is the level where there is contamination? What do you do if you find an area that is contaminated?

Note section on removable contamination survey

Reports

Under certain circumstances, the NRC requires telephone and/or written notification of theft or loss of radioactive material, overexposure of personnel, radioactive releases, planned special exposures and the results of individual monitoring (10 CFR 20, Subpart M).

Sealed source inventory will be done quarterly - 10CFR 34.29

Theft or loss of radioactive material:

  1. If more than 100 mCi of Mo-99 or  1000 mCi the NRC will be  immediately telephone and notified.
  2. A telephone report is required within 30 days if the radioactive material lost or stolen exceeds 10 times the quantity specified in appendix C to 10 CFR 20.1001-20.2402 and the radioactive material is still missing at the end of the period (10 CFR 20.2201(a)(1)(ii)).
  3. In addition, any required telephone report must be followed up by a written report within 30 days from the date of the telephone report (10 CFR 20.2201(b)).

Overexposure of personnel:

  1. The NRC will be immediate notification if  any individual receives a total effective dose equivalent of 25 rems or more, a lens dose equivalent of 75 rems or more,  or a shallow dose equivalent to the skin or extremities of  250 rads or more (10 CFR 20.2202(a)).
  2. The NRC will be notified within 24 hours if  any individual receives a total effective dose equivalent exceeding 5 rems, or a lens dose equivalent exceeding 15 rems, or a shallow dose equivalent to the skin or extremities exceeding 50 rems (10 CFR 20.2202 (b)).
  3. The immediate and 24 hour reports will be made by either telephone, fax, telegram or mailgram and then followed up within 30 days by a written report (10 CFR 20.2203(a)(1)).
  4. The NRC will be sent a written report within 30 days if anyone exceeds the occupational dose limits for adults, minors, a declared pregnant woman, or an individual member of the general public or for any incident in which any applicable limit for the release of radioactive material is exceeded (10 CFR 20.2203(a)(2)).

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