Appendix K - Medical University of South Carolina

APPENDIX K

DEPARTMENTAL QUALITY ASSURANCE PROCEDURES

RADIATION ONCOLOGY

PAGE

PROSTRATE BRACHYTHERAPY PRESCRIPTION................................. 205

CALIBRATION CHECK OF THERAGENICS Pd-103 SEEDS........................ 206

PROCEDURE FOR SEED HANDLING.......................................... 207-208

PROCEDURE FOR DAY OF IMPLANT ........................................ 209-211

PROCEDURE FOR DAY FOLLOWING IMPLANT ................................. 212-213

HDR TREATMENT RECORD AND PRESCRIPTION FORM HDR-100................... 214

NUCLETRON OPERATING PROCEDURES ...................................... 215 HDR Ir-192 SOURCE EXCHANGE AND CALIBRATION PROCEDURES................ 216-217

NUCLETRON HDR PATIENT TREATMENT CHECKS............................... 218

INTRACAVITARY BRACHYTHERAPY PRESCRIPTION............................. 219

BRACHYTHERAPY AND RADIOPHARMACEUTICAL TREATMENT...................... 220

CESIUM THERAPY RECORD ............................................... 221

PATIENT ROOM SURVEY ................................................. 222

CESIUM WARD RECEIPT ................................................. 223

NURSING PRECAUTIONS FOR PATIENTS RECEIVING BRACHYTHERAPY............. 224

BRACHYTHERAPY SUMMARY SHEET ......................................... 225

CHECKLIST FOR MEDICAL APPLICATION OF HDR............................. 226-231

ONCOLOGY RADIOACTIVE MATERIAL INSPECTION SHEET....................... 232-235

204

Medical University of South CarolinaRadiation Oncology Department

Permanent Implant: Prostrate Brachytherapy Prescription

Name: ______________________ Birth Date: ____________ SS#: ______________________Rad Onc # ___________________ Rad Oncol.: ___________ Ref. Phys. _________________Primary Site: ________________ Isotope: ______________ Date of Implant: ____________

Treatment Plan:

Radionuclide: ____________________

Number of sources (seeds): _______________________

Source strength: ____________ mCi per seed

Treatment Site: _____ Prostrate, _____ other

Dosimetric Objective: ______ Gy to _____ of PTV

MD Signature _______________________ Date: ______________

Oral Revision:

Oral revision of Treatment Plan _______ (C heck if applicable).

Description of Revision:______________________________________________________________________

__________________________________________________________________________________________

__________________________________________________________________________________________

Documented By: ________________________

Final Treatment:

Date: ____________ Patient Identified by two methods: ______ name, ______ DOB, ______ SS#

Radionuclide: _________________________

Number of sources (seeds): _________________________

Source Strength at Loading ______________mCi per seed

Treatment Site: _____ Prostrate, _____ other

Number of seeds recovered in Cysto: _________________________

Total # of seeds Implanted: _________________________

MD Signature _____________________ Date: ______________

205


CALIBRATION CHECK OF THERAGENICS Pd-103 SEEDS

DATE: RO#: P.O.#:

PATIENT: IMPLANT DATE: DR: Milito

MANUFACTURER: Theragenics Corp. LOT#: MODEL: 200

MANUFAC TURER � S CALIBRATION DATE: AT 12:00 EST.

NO. OF SEEDS:

ACTIVITY/SEED: mCi on (Manufacturer � s value)

TOTAL ACTIVITY: mCi on (Manufacturer � s value)

ELAPSED DAYS DECAY FACTOR

TOTAL ACTIVITY: mCi on (Manufacturer � s value)ACTIVITY/SEED: mCi on (Manufacturer � s value)

Activity was measured using C NMC AtomLab 44 E Brachythera py Programm able Electrometer with

CNM C Model 44D R e-entrant Ionization Chamber calibrated 10/7/99 by K&S Associates ADCL using seed holder

with narrowed tip for seed - red scribe set to top of � holder clamp � .

Seed # RdgPd-103

Setting ***

CalibrationFactor*

(mCi/Rdg)

Calc.Activity(mCi)

CalibrationFactor

(Pd-103)**

Calc.Activity(mCi)

PercentError

%

1 1.005 0.7752 #DIV/0!

2 1.005 0.7752 #DIV/0!

3 1.005 0.7752 #DIV/0!

4 1.005 0.7752 #DIV/0!

5 1.005 0.7752 #DIV/0!

6 1.005 0.7752 #DIV/0!

7 1.005 0.7752 #DIV/0!

8 1.005 0.7752 #DIV/0!

9 1.005 0.7752 #DIV/0!

10 1.005 0.7752 #DIV/0!

11 1.005 0.7752 #DIV/0!

12 1.005 0.7752 #DIV/0!

13 1.005 0.7752 #DIV/0!

14 1.005 0.7752 #DIV/0!

15 1.005 0.7752 #DIV/0!

SUM:

AVG #DIV/0! #DIV/0!

%STD: #DIV/0!

*NEW CHAMBER CALIBRATION FACTOR ON 10/7/99 by K&S Associates ADCL**Using Manufacturer �s Pd-103 calibration factor (divide by 1.29 to get manufacturer �s value)***per Larry Bryson. K&S Associates ADCL

CHECKED BY: ____________________________ DATE: __________________

APPROVED BY: ____________________________ DATE: __________________

206


PROCEDURE FOR SEED HANDLING

1. Upon Receipt of Seeds from Radiation Safety:

A. Seeds must be counted and calibrated.

1. Recommended counting seeds to an intermediate container in groups of tens inorder to reduce the number of seeds in any group that must be recounted in case oferror or confusion. Do all counting on the Plexiglas tray provided. Place everytenth seed into the calibrator and count.

2. A minimum of least 10 seeds must be placed in the calibrator and calibrated oneat a time.

2. Preparation of Loading Seeds into Needles:

A. The Plexiglas tray located in the 250 Room should be placed on the short counter to theright of the door as you enter the 250 Room.

1. Open a pillow case on the tray to provide a light-colored resilient surface to workon.

a. Seeds have a tendency to � skitter � when they fall on a hard smoothsurface.

2. Assemble and arrange the vacuum-assisted seed loader on the working tray withthe pump on your strong side (right-handedness Vs. left-handedness). The powerdistribution cord and switch should be on the side nearest the door for easy accessby the person helping to count.

3. The following instruments should be at hand:

a. Special seed handling forcepsb. Special seed handling hemostatc. Modified sponge forceps (11-inch)d. Modified curved forceps (11-inch)e. Metal rulerf. Spare pigg. Stainless steel bowl (3-inch)h. Slip shield set with wrenchi. Eberline G-M counter with pancake probe

4. The following materials are needed:

a. The appropriate number of needles as determined by the computer-generated plan supplied by the physician or physicist plus one unopenedpackage of 5 needles.

207


PROCEDURE FOR SEED HANDLING CONT.

b. 5 mm catgut spacers (minimum of one spacer per seed)c. One (1) package of bone wax

B. Position needles with stylets in place into the slip shields.

1. Seat the needles all the way to the cap of the slip shield being carefulNOT to damage the point of the needle.

2. Tighten the set screw on the slip shield with the allen wrench provided.

a. DO NOT OVER-TIGHTEN!

3. Mark the slip shield with the number of seeds it is to contain.

C. Load needles with the vacuum-assisted seed loader in accordance with the manufacturer �sinstructions. The needle is loaded from the sharo end.

1. Each seed placed into the needle must be preceded by a spacer.

a. A three seed needle would have a spacer-seed (1)-spacer-seed (2)-spacer-seed (3).Always begin with a spacer and end with a seed!

2. Two persons must be present to count and verify seed loading.

3. Seal each loaded needle with bone wax by pushing needle through bone wax,giving a slight twist. Remove and replace slip shield cover.

4. Use caution and be gentle when replacing stylets.

a. If bone wax is pushed out, then the needle must be reloaded.

5. Place the completed needle with slip shield cover into the carrier.

a. Whenever possible the individual tilting blocks on the carrier should belabeled with the seed per needle count.

6. Fill out the radioactive materials tag and carry the set to Sterile Processing (firstfloor of Children �s Hospital) to be GAS sterilized. Log in the seeds in the SterileProcessing logbook.

7. Survey the preparation area for any lost or stray seeds.

8. Store all equipment and materials in their proper place.

208


PROCEDURE FOR DAY OF IMPLANT

1. Load the following supplies on the utility cart marked � RAD ONC �

A. Sterile Supplies:

1. Package with � L � block2. Package with needle array block, template, seed and needle manipulation block3. Genesis Pan with needle set and seeds

B. Items to be � Flashed � upon arrival at OR:

1. Special seed handling forceps2. Special seed handling hemostats3. Lead pig marked � OR �4. Modified sponge forceps5. Modified curved forceps6. Metal ruler

C. Spare package of five (5) sterile needles

D. Eberline G-M counter with pancake probe

E. Copy of treatment plan showing needle distribution and the lot number of the seeds thatyou are using.

F. Two packages (2 needles each) of Prostrate Fixation Needles.

2. Change to scrubs and be at OR 20-30 minutes prior to patient �s scheduled time.

A. Scrubs including cap and mask are required but not normally required to � scrub � handsand gown.

B. Give items to Nurse to be flashed.

C. Assist Nurse in setting up apparatus.

1. The needle array block should be nearest the patient at the foot of the table.

a. The remainder of the sterile equipment should be logically placed alongside of the needle block. However, the exact position will depend on theOR that you are in.

2. Open the square needle package and place spare needles in the needle seedmanipulation block on the � L � block PRN.

3. The needle set must be opened and placed on the table for the doctor who will bescrubbed and gowned.

209


PROCEDURE FOR DAY OF IMPLANT CONT.

D. Read the needle distribution plan to the doctor and double check the location and seedcount of the needles as they are placed in the needle array block.

1. Use of the phonetic alphabet is useful in avoiding confusion but it is not vital.

E. Place the G-M counter on one of the non-sterile table.

1. Ensure that the RAD ONC doctor knows its location.

F. Place your name and phone/beeper number on the board in the OR.

G. Mark the � rad onc � utility cart further by a large strip of tape marked � RAD ONC, DoNot Use �

1. Leave the Genesis pan with the radioactive materials tag visible on the cart.

2. Place the cart out of the way outside of the OR. NOTE: Use any precautionsnecessary to prevent loss of the utility cart and Genesis pan.

3. At commencement of cystoscopy you will be called to the OR.

A. Verify seed work area is no longer sterile.

B. Extrude seeds from unused needles, count and place in pig.

C. Survey work area with G-M counter for misplaced seeds.

1. If seeds are located, count and place in pig.

D. Be prepared to accept any seeds that may be located and recovered by cystoscopy. Countand place in pig.

E. Survey suction machine, bedding, urine, trash and bedding for errant seeds. If located,count and place in pig.

F. When patient has departed room, make one last survey of the OR so cleanup cancommence.

G. INVENTORY ALL YOUR INSTRUMENTS; place on the utility cart and return toRadiation Oncology.

1. The template must be cleaned and decontaminated by the OR staff.

a. Ask them to return the template with the rest of the ultrasound equipmentto Urology.

b. Pick up the template the next day at Module 11.

210


PROCEDURE FOR DAY OF IMPLANT CONT.

4. When the procedure is finished in the OR:

A. Be sure to have the urology resident put in his orders to have RAD ONC notified whenthe patient is sent from recovery to his room.

1. Have the doctor to order all linens, dressings, and urine to be saved.

B. When the patient is in his room:

1. Attach the Radioactive materials sign to his room door.

2. Attach the pig marked � radioactive materials � in a prominent position in theroom.

a. This pig is for Nursing to use if they should find a seed.

3. Place � Nursing Precautions for Patients receiving Radioactive Brachytherapyfor Prostrate Cancer � form in the patient �s chart.

a. Note that the urine is to be saved.

4. Fill out and place into the patient �s chart a � Permanent Implant Room SurveyForm �.

C. In the Radiation Oncology Department:

1. Make an entry in the R/O patients chart on the progress notes.

a. Include date, number of seeds, average activity, total activity, number ofneedles, how and by whom they were placed.

2. Complete the log book located in the Dosimetry Office.

211


PROCEDURE FOR DAY FOLLOWING IMPLANT

A. When Nursing notifies the Radiation Oncology Department, the room must be surveyed.

1. Using the G-M counter with the pancake probe, survey the patient �s room, linen, trashand urine.

a. If seeds are located, count them and place in the pig provided.

2. When the room is clear of radioactive materials, remove the Radioactive Materials signfrom the door.

a. Notify Nursing that the room is clear.

b. Make an entry in the patient �s chart on the progress notes to the effect that theroom is clear and ready for normal occupancy.

B. Place all recovered seeds into the pig they were shipped in.

1. To be performed in Radiation Oncology spaces.

2. This includes all seeds.

a. Those recovered from the patient �s room.

b. Those recovered from the OR.

c. Any that may have been left over from the loading.

3. Fill out the white Radiation Safety form on disposition of radioactive materials.

a. Radiation Safety would have delivered the seeds and had you sign for them on theoriginal disposition form.

4. Seeds and form are turned over to Radiation Safety for disposal.

C. Make an entry in the patient �s R/O chart on the Progress Notes stating that the room wassurveyed, clear and ready for normal occupancy.

D. Pick up the template from Module 11 and prepare your sterile packs for the next procedure.

212


PROCEDURE FOR DAY FOLLOWING IMPLANT CONT.

1. Materials to be Pre-packaged and Sterilized the Week Before the Next Procedure:

A. Package 1: � L � block, window and base (to be gas sterilized)

B. Package 2: 1. Needle array holder (place upside down and load with remaining items.(To be steam sterilized)

2. Template and adjustment rods.

3. Seed and needle manipulation block.

2. Materials to flash 30 minutes prior to the scheduled procedure (can be done in one package):

A. Package 1: 1. � Diddler �

2. Special seed handling forceps

3. Special seed handling hemostats

4. Lead pig marked � OR �

5. Modified sponge forceps (11-inch)

6. Modified curved hemostats (11-inch)

7. Metal ruler

8. Slip shield wrench

3. Materials to be GAS Sterilized second day prior to procedure (i.e., Monday afternoon when theprocedure is on Wednesday)

A. Package 1: 1. Needle set loaded with seeds and spacers. (Carry to Sterile Processing. They will pack into a Genesis pan for protection. Needles are to beprocessed in an horizontal position. The external package cover willhave a Radioactive Materials tag attached. Loaded needles should notbe placed in the General Pickup bins when finished, they should be heldin the Office or at least in the Processing area for pickup.)

4. Carry to OR for use PRN.

A. 1 package of spare needles

B. 2 packages of Prostrate Fixation Needles

1. One package (of 2 needles) must be opened for use.

C. 1 package of spacers

213


HDR TREATMENT RECORD AND PRESCRIPTION FORM HDR-100

PATIENT: ____________________________________________ RT#: ________________________

PRESCRIPTION FORM DIAGRAM

INITIAL PRESCRIPTIONISOTOPE: Ir-192 DEVICE: Nucletron HDR SN 9349Dose delivered to:____________________________________Treatment Site: ______________________________________Time between fractions: _______________________________Dose/Fract: ________ No.Fract:_______Total Dose:________Signed: ________________________MD Date: ____________

INITIAL PRESCRIPTIONISOTOPE: Ir-192 DEVICE: Nucletron HDR SN 9349Dose delivered to:____________________________________Treatment Site: ______________________________________Time between fractions: _______________________________Dose/Fract: ________ No.Fract:_______Total Dose:________Signed: ________________________MD Date: ____________

INITIAL PRESCRIPTION

ISOTOPE: Ir-192 DEVICE: Nucletron HDR SN 9349

Dose delivered to:____________________________________

Treatment Site: ______________________________________

Time between fractions: _______________________________

Dose/Fract: ________ No.Fract:_______Total Dose:________

Signed: ________________________MD Date: ____________

TREATMENT RECORD

DATEFRACTION NO: 1 2 3 4 5 6ISOTOPE Ir-192 Ir-192 Ir-192 Ir-192 Ir-192 Ir-192No. OF CATHETERSAPPLICATORSDOSE THIS FRAC TION (cGy)SOU RCE STRE NGT H (Ci)No. OF DWELL POINTSTOTAL D WELL TIM E (Sec)PHYSIC S REVIEW (Physicist)TREATMENT AUTHORIZED BY (MD)TOTAL DOSE (cGy) TO DATEDELIVE RED B Y (Therapist)mR/hr POST TREATMENTSPECIAL PHYSICS REPORTMD REVIEW/DATE

214


NUCLETRON OPERATING PROCEDURES

The following operating procedures will be used in setting up and treating patients with the NucletronmHDR unit in Treatment Rooms 1, 2, and 3.

1. When the treatment is scheduled for one of the treatment rooms, the mHDR unit will be movedfrom the Storage Room to the specific treatment room by the Physics/Engineering staff.

2. The mHDR unit will be connected to the electrical power cables in the treatment room by thePhysics/Engineering staff.

3. The Nucletron control console cabinet will be moved to the treatment room console area andconnected to the power cables and interlock circuitry by the Physics/Engineering staff.

4. The units will be turned on and tested for proper operation by the Physics/Engineering staff.5. The proper operation of the door interlock system will be tested by the Physics/Engineering staff.6. The radiation monitoring system will be tested by the Physics/Engineering staff.7. The intercom and CCTV system will be tested by the Physics/Engineering staff.8. The Physics staff will perform the QA checks in the QA procedures the day of treatment.9. When the patient treatment plan is completed and approved by the attending physics, the Physics

staff will check the treatment data and the treatment plan in the treatment console.10. When all QA checks are satisfactorily completed, the therapist will take the patient into the

treatment room for treatment.11. A survey meter will be located at the control console during the treatment. It will be turned on

and checked prior to the treatment by the therapist.12. An emergency kit will be located near the console.13. A physicist and physician will be present during the treatment.14. Following the completion of the treatment, the therapist and physician will disconnect the

treatment unit from the patient, remove the treatment apparatus and remove the patient from thetherapy room.

15. The therapist will perform a radiation survey of the patient after the patient is removed from thetreatment room and log the results in the patient treatment form. A copy of this form will bephotocopied and placed in the HDR QA Log Book, under daily QA section.

16. The physician will complete the patient treatment chart and the physicist will check it.17. The physicist will log the treatment information into the HDR Treatment Log Book.18. The physicist will write a Special Physics Report for HDR Brachytherapy and place it into the

patient chart.19. The Physics/Engineering staff will disconnect the mHDR treatment unit and control console and

switch the door interlock system back to the linac mode.20. The Physics/Engineering staff will return the mHDR treatment unit and console cabinet to their

storage rooms and secure the rooms by locking them.

215


HDR Ir-192 SOURCE EXCHANGE AND CALIBRATION PROCEDURES

The Ir-192 source used in the Nucletron Microselectron HDR is changed approximately every threemonths. Following each source exchange, the new source is calibrated to determine its true activity byone of the staff medical physicists. The entire procedure for the source exchange and calibration is givenbelow.

1. Receiving New Source

Nucletron notifies the Section of Medical Physics as to the date the new source will arrive. Oncethe source reaches the department, it is placed in Room 165Q. Within three hours of arrival, awipe test is done of the source container to detect any removable contamination. (Wipes can beobtained from the MUSC Radiation Safety Office. Physicist can wipe the surface of the HDRsource container and submit the wipe in an envelope to RSO for counting.) The container is notto be opened until a negative wipe test result is received. Within a week of receiving the source,a service engineer from Nucletron should arrive to carry out the source exchange.

2. Exchanging Old Source with New Source

When the Nucletron engineer arrives, he removes the old source from the HDR unit and depositsit in the empty pig which is kept in the Room 165Q. With the old source out, preventivemaintenance is carried out by the engineer on the unit. Upon completion of this preventivemaintenance, the engineer installs the new source in the unit. The old source is packed in itsshipping container and kept in Room 165Q until pickup. To arrange for the pickup of the oldsource the physicist in charge of the source exchange contacts Nucletron (1-800-336-2249 - askfor RSO) and informs (via fax or phone) them of the transportation index (T.I.) Of the source, thedecayed activity of the source and the source number (there is a form in the HDR SourceExhcange file for faxing). The appropriate documents are then sent to the physicist by Nucletronand return shipment is made by Federal Express.

3. Source Calibration

Once the new source is in place in the HDR unit, one of the departmental medical physicistscalibrates the source to determine its actual activity. The steps required to perform thecalibration are the following.

a. Warm up the Atom Lab calibrator for at least 30 min. prior to making calibrationmeasurements.

b. Use the insert with the long catheter and secure it at the RED mark on the holder.

c. Connect the end of the catheter to the first index of the HDR unit.

d. From outside the treatment room, program the HDR console for � dwell position 1, length995 mm, dwell time 60 sec � and record the electrometer reading in nanoAmp. In theHDR calibration form. Repeat this 3 more times. Using these measurements, and thecalibration factors of the well chamber and electrometer, the source activity isdetermined. With the calibration setup timer linearity is also checked by takingelectrometer readings for different dwell times eg. 30, 60, 120 and 180 sec. and plot theelectrometer readings against the dwell times.

216


e. Once the source activity has been determined and is found to be in acceptable agreement(< 3%) with the activity stated on the manufacturer �s certificate, the new activity(measured) is entered into the HDR console memory and the HDR treatment planningcomputer program.

4. Documentation:

The following documents are kept on record (in the � HDR Source Exchange Doc. � Log book) for eachsource exchange.

1. The Certificate for Sealed Source which comes with each source from MallinckrodtDiagnostica.

2. The pink and white delivery slip.

3. The Nucletron Radiation Survey/Source Exchange document from the Nucletron engineer.

4. The Nucletron Field Service Report.

5. The departmental Incoming Package Survey sheet.

6. The wipe test results.

7. Record of Source Calibration done by department physicist (includes source calibration, andtimer linearity check).

8. Declaration of Dangerous Goods for outgoing source.

9. Copy of Federal Express airbill for outgoing source.

10. Copy of Shippers Instructions for outgoing source.

11. Photocopies of Radioactive package labels for outgoing source indicating the T.I. and decayedactivity.

12. Wipe Tests results for outgoing source.

217

PM

AM


NUCLETRON HDR PATIENT TREATMENT CHECKS

PATIENT: _______________________ R.O# __________ DATE: ___________ TIME:_________

TREATM ENT PRESCRIPTION :____________________________cGy AT __________________

APPLICATOR: ____________________________________________ #CA THETERS: _________

SPECIAL NOTES:__________________________________________________________________

A. PRE-TREATMENT CHEC KLIST: (ALL ITEMS MUST BE SATISFACTORY BEFORE TREATMENT

CAN PROCEED)

1. Patient Identification verified by two means? . . . . . . . . . . . . . . . . . . . . . . . . . .YES ______ NO ______

2. Treatment Rx (Form HDR-100) completed by physician?. . . . . . . . . . . . . . . . YES ______ NO ______

3. Patient Consent Form is signed? . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . YES ______ NO ______

4. Computer Tx plan complete and apporved by physician?. . . . . . . . . . . . . . . . YES ______ NO ______

5. Computer Tx plan downloaded into treatment console?. .. . . . . . . . . . . . . . . . YES ______ NO ______

6. Note any discrepancies between computer plan and console plan? . . . . . . . . . YES ______ NO ______

7. Does current console source strength and computer plan match within 1%?. YES ______ NO ______

8. Does current console source strength match daily decay chart within 1%?. . YES ______ NO ______

9. Has printed treatment plan been approved by physician?.. . . . . . . . . . . . . . . . YES ______ NO ______

10. Are all treatment tubes correctly attached to the Selectron and patient?. . . . .YES ______ NO ______

11. Is the patient comfortable and instructed regarding the treatment? . . . . . . . . YES ______ NO ______

12. Are the intercom and TV monitors operating properly? . . . . . . . . . . . . . . . . . YES ______ NO ______

13. Door/emergency interlocks fuctional? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .YES ______ NO ______

14. Battery Back-up checked?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .YES ______ NO ______

15. Positional accuracy checked?. . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . YES ______ NO ______

16. Emergency Interrupt Functional?. . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . .. YES ______ NO ______

B. POST-TREATMENT CHEC KLIST:

1. Note any patient complaints?. . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .YES ______ NO ______

(Explain:) ___________________________________________________________________________________

_________ ___________________________________________________________________________________

2. Have copies of the treatment log and data been placed into patient chart? . . .YES ______ NO ______

3. Have all disposable items been properly bagged, tagged and disposed of? . . . YES ______ NO ______

4. Have all reusable items been cleaned and sterilized? . . . . . . . . . . . . . . . . . . . . .YES ______ NO ______

5. Have all HDR items been returned to their proper location? . . . . . . . . . . . . . . YES ______ NO ______

6. Has patient treatment information been entered into HDR logbook?. . . . . . .. YES ______ NO ______

7. Has patient been surveyed after source removal? . . . . . . . . . . . . . . . . . . . . . . ..YES ______ NO ______

8. G-M Su rvey meter readings: Eberline E-120 , SN: ________ __;

check Source Reading: (x1 Scale): _______

9. Patient Surv ey Readin gs:

mR/hr @ surface of patient: ________________; mR/hr at 1 foot from patient: ___________

CHECKED BY: ______________________________________ RT(T); DATE: ___________________

RADIATION TH ERAPIST

218

Size =

Total Time (h)

Mg-h

Total mg-h

Time in

Day in

Date in

Time out

Day out

Date out

Source#

IsotopeSource Strength (mgRaEq)

Tandem/Vag. Cylinder

LeftOvoid

RightOvoid

1 Cs-137

2 Cs-137

3 Cs-137

4 Cs-137

5 Cs-137

6 Cs-137


Intracavitary Brachytherapy Prescription

Name: ______________________________ Birth Date: _______________ SS#: _________________

Rad Onc # ___________________________ Rad Oncol.: ______________ Ref. Phys. ____________

Primary Site: _________________________ Diagnosis:________________ Isotope: _____________

Date of Implant: ______________________ Implant #: ________________ Applicator: __________

Nominal Source Configuration

Isotope: ___________Tot. Strength: ______ mgRaEqRx Approved by: ___________ Date: ___________

Rx Revised: _______________ Implant Removed at: Time _______ Date: ____________________________________________________________ by __________________ Total Tx Time __________ hrs._________________________ Tx delivered as Prescribed: ___________________, MDMD Sign: _____________, MD Date: ______________ Date: _____________

219

Radiation Oncology, Brachytherapy and Radiopharmaceutical Treatment

Verification

1. Patient Name: _______________________________________

2. Patient #: ___________________________________________

3. Attending Physician: __________________________________

4. Date: _______________________________________________

5. Dose Prescription:_____________________________________________________________

6. Site of Treatment:_____________________________________________________________

7. Radionuclide to be used: _______________________________________________________

8. Form: _______________________________________________________________________

9. Activity: _____________________________________________________________________

10. Method of administration: ______________________________________________________

11. Activity proposed to be used: ____________________________________________________

12. Activity actually used: _________________________________________________________

13. Reason for deviation: __________________________________________________________

14. Patient ID verified by: a. person ______________________________

b. date ________________________________

c. method 1 ____________________________

d. method 2 ____________________________

15. Sources to be used verified by: a. person 1. _______________ 2. _______________

b. date _____________________________________

c. Method __________________________________

16. Sources removed (if applicable) __________________________________________________

17. Date ____________________________

18. Exposure level at 1 meter at time of source removal or patient discharge__________________________ by _______________________ date ____________________

19. Comments: ___________________________________________________________________

_____________________________________________________________________________

220

CESIUM THERAPY RECORDMEDICAL UNIVERSITY HOSPITALRadiation Oncology Department

Name _________________________Sex ________ Age ______ Hospital No. ____________________

Clinical Diagnosis ____________________________________________________________________

Histologic Report ____________________________________________________________________

Location of Lesion Treated ____________________________________________________________

Method of Lesion Treated _____________________________________________________________

Method of Cesium application _______________________Technique_________________________

Therapist _________________________________________Assistant _________________________

Time ofapplication

date signature Total Amt. Cesium _________________mg.

Duration _________________________hrs.

Proposed Dose ___________________mgrs.

ProposedTime ofRemoval

date signature No. Mr. Sizemm.

Filtermm. Pt.

LinearIntensity

Actual Timeof Removal

date signature

Total Time Applicator Was in Place

Calculated Tissue Dosage: (gamma r & mg hrs)

Diagram & Remarks:

221

MEDICAL UNIVERSITY OF SOUTH CAROLINARadiation Oncology Department

PATIENT ROOM SURVEY

(Name Plate Stamp)

PATIENT: ______________________ ROOM: __________in @ _____________________ am/pm on _________out @ ____________________ am/pm on _________

Total hours: _____________________ By: ______________

Total amount of _________ used: _________ mgm-Ra-EquivSource #1: _____ #2 _____ #3 _____ #4 _____ #5 ____ #6 ____

Radiation Readings in Room: (mR/hr) at Bed Location: _____(See Diagram Below for appropriate Roo m Bed Layo ut to Select)

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CESIUM WARD RECEIPT

DATE: _______________________________________

TIME OF INSERTION: __________________AM/PM

NUMBER OF HOURS: _________________________

TIME OF REMOVAL: ___________________AM/PM

APPLICATORS & LOADING

SOURCES, NUMBER & DESCRIPTION:

_____________________________________________________________________

_____________________________________________________________________

TOTAL NUMBER OF SOURCES: ______________________________________

REMOVAL OF CESIUM:

REMOVED BY: ___________________ DATE: _____________ TIME: _________AM/PM

CHECKED BY: ___________________ DATE: _____________ TIME: _________AM/PM

RECEIVED IN CESIUM ( � RADIUM � ) ROOM: ____________________________ AM/PM

SURVEY READINGS:

READING AT 1 METER (3 FEET): ___________________mR/hr

READING AT DOOR: _______________________________mR/hr

READING AFTER CESIUM REMOVED FROM PATIENT AND

ROOM: ____________________________________________mR/hr

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NURSING PRECAUTIONS FOR PATIENTS RECEIVING RADIOACTIVEBRACHYTHERAPY

PATIENT: ___________________ PATIENT #: ___________________ ROOM #: ____________was administered ________mg-Ra-Eq of _________ on (Date:) __________ at (Time:) _________AM/PMBy: ____________________________________ M.D.; Pager #: ______________________ Phone: (2-3271)

NO VISITORS ARE ALLOWED IN ROOM DURING TREATMENT

PLEASE OBSERVE THE FOLLOWING NURSING PRECAUTIONS UNTIL ALL SOURCES ARE REMOVED FROM PATIENT AND ROOM IS SURVEYED.

1. All brachytherapy patients must be placed in a private bathroom. If only one brachytherapypatient is to be placed in a room, place the patient in a bed farthermost from the door.

2. Portable lead shielding may be required to reduce personnel exposure at bedside. Please standbehind this shield when attending the patient, if possible.

3. The patient shall remain in the room while the source(s) are in place. If the patient accidently orintentionally removes the source(s) from his/her body, IMMEDIATELY CONTACT THERESIDENT ON DUTY. He/She will place the source(s) in a portable shielded carrier. UNDERNO CIRCUMSTANCES SHOULD YOU PICK UP OR TOUCH THE SOURE(S). In the eventof lost, damaged, or ruptured source(s), CONTACT THE ABOVE PHYSICIAN AND THEMUSC RADIATION SAFETY OFFICER (2-4255). Stop all traffic into or out of the area andturn off all room air-conditioning or ventilation. Close the door and label � Contaminated Area-Do Not Enter without Protective Clothing! �

4. The patient must be surveyed after all source(s) are removed from the room and the results of thesurvey shall be noted in the patient �s chart and the MUSC Cesium Ward Receipt form. Theroom also shall be thoroughly surveyed before release for use.

5. Patient excreta may be disposed of in the normal manner unless noted otherwise in theseinstructions:

6. Nursing personnel attending the patient may be required to wear film badge monitors at thediscretion of the MUSC Radiation Safety Officer (RSO). If issued by the RSO, the film badgemonitor is to be worn either at waist level, on a pocket, or on the collar. Film badge monitors areto be worn ONLY by the individual to whom they are issued. Contact the RSO (2-4255) ifadditional monitors are needed.

7. Only designated residents, radiation oncology residents, attending radiation oncologists, radiationphysicists, radiation oncology dosimetrists, radiation therapists, or RSOs shall removebrachytherapy sources from a patient.

8. In case of death, DO NOT REMOVE THE BODY FROM THE ROOM until the RSO (2-4255)has issued appropriate instructions. Contact the RSO, Radiation Oncology (2-3271) or theCentrex Operator (2-2123) for emergency phone numbers or pager numbers if no answer at eitheroffice.

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1. Intracavity ______

2. Interstitial ______


BRACHYTHERAPY SUMMARY SHEET

PATIENT: _________________________________________ #: _________________________________

DIAGNOSIS: _______________________________________ TREATMENT DESCRIPTION:

TREATMENT SITE: ________________________________

APPLICATION SITE: 1. Fletcher: ____; 2. Delclos: ____; 3. Seeds: ____

SOURCES: 1. Cesium: ______________; 2. Other: ______________________________

LOADING: (Cesium) Tandem Ovoids EXTERNAL BEAM: 1 21) ________ _______ Whole Pelvis _____ _____2) ________ _______ Parametrium _____ _____LOADING: (Other) ____________________ Other: ____________

CESIUM I CESIUM II

________cGy/hr x ______ = ______ Dose to A-R ________cGy/hr x ______ = ______ Dose to A-R

________cGy/hr x ______ = ______ Dose to A-L ________cGy/hr x ______ = ______ Dose to A-L

________cGy/hr x ______ = ______ Dose to A-Avg ________cGy/hr x ______ = ______ Dose to A-Avg

________cGy/hr x ______ = ______ Dose to B-R ________cGy/hr x ______ = ______ Dose to B-R

________cGy/hr x ______ = ______ Dose to B-L ________cGy/hr x ______ = ______ Dose to B-L

________cGy/hr x ______ = ______ Dose to Bladder ________cGy/hr x ______ = ______ Dose to Bladder

________cGy/hr x ______ = ______ Dose to Rectum ________cGy/hr x ______ = ______ Dose to Rectum

________cGy/hr x ______ = ______ Dose to Surface ________cGy/hr x ______ = ______ Dose to Surface

TOTAL DOSES

Date Hrs Mg-Hrs A-R A-L B-R B-L Bladder Rectum Surface

External

I

External

II

TOTAL

_____________________________________________________M.D., Date: _________________________

225

CHECKLIST FORMEDICAL PROGRAM APPLICATION

(REMOTE AFTERLOADING BRACHYTHERAPY DEVICES)

Yes No

1. Did the applicant submit the name and address for the proposed location of use in items 1a. 1b.

2. Did the applicant submit the following information pertaining to radioactive material requested and

the purpose used for in items 6 & 7:

Source

a. Radionuclide(s): ___________________

b. Activity (Ci): ____________

c. Manufacturer & Model Number(s): ____________________________________________

_________________________________________________________________________

d. Listed in the �Registry of Sealed Sources and Devices � . (List reference no. ____________)

Device

a. Manufacturer & Model Number(s): ____________________________________________

_________________________________________________________________________

b. Listed in the �Registry of Sealed Sources and Devices � . (List reference no. ____________)

c. Device type: LDR ______ MDR ______ HDR _______ Pulsed ______

3. Intended use:

a. Interstitial/Intracavitary

b. Intraluminal

c. Human only

d. Other: ___________________________________________________________________

4. Did the applicant subm it the full names of all physicians who will use or directly supervise the use

of radioac tive material.

5. Did the applicant include preceptor statement forms (DHEC form 814) for each physician requested

to be an authorized user.

a. Proper training and experience.

b. Licensed to practice medicine in S.C.

c. Preceptor statement signed for non-certified new users, etc. (Ref: Supplements A and B)

6. Did applicant submit training and experience for physicist. (Ref: RHA 4.15.12)

7. Did applicant submit information concerning their personnel training program:

Authorized Users and Device Operators

a. Subjects to be included in initial training.

226

b. � Hands On � operation training.

c. Trained operators present during use.

d. Annual retraining.

- Subjects to be included during retraining.

- � Hands on � emergency procedure implementation.

Instructors - Initial training

a. Name, affiliation, qualifications.

b. Experience with afterloading device(s).

Records of training maintained.

8. Did the ap plicant subm it the following info rmation co ncerning their facilities and eq uipment:

a. Dedicated Room (High, Pulsed, and Medium Dose Date)

- Annotated drawing.

- Scale.

- Room numbers (Room Identification).

- Shielding ma terial.

- Adjacent areas; restricted/unrestricted; include areas above and below treatment room.

b. Viewing system and intercom.

- Primary.

- Backup.

- Provision if primary system fails without backup.

c. Access co ntrol.

- Electrical interlock.

- System operation.

- Response to interruption.

- Commitment to suspe nd treatment if interlock malfunctions.

- Area controls (signs, locks, visible/audible alarms).

- Other radiation-produc ing devices.

- Method to prevent dual operation.

- Security of console keys.

d. Permanent radiation monitor.

- Visible notic e on entry.

227

- Back-up power sup ply.

- Operability check.

- Emergency entry provisions.

- Commitment to promptly repair/replace.

9. Compliance with restricted/unre stricted area radiation level limits.

a. Calculation s of maximu m radiation levels for restricted /unrestricted a reas to dem onstrate

compliance with RHA 3.5 and 3.13.

- Parameters used to calculate radiation levels (source strength, shielding materials, room

configuration, etc.).

- Anticipated workload d ata, occupancy factors.

- Dose calculations for individuals in restricted and unrestricted areas.

- Dose levels comply with RHA 3.5 and 3.13.

- Exemption from RHA 3.13.

- Need for exemption specified.

- Duration of exemption specified.

- Program to access and control dose.

b. Survey program to demonstrate compliance with RHA 3.16.

- Survey of device following source replacement or location of device changes.

c. Device label in accordance with RHA 3.24.

10. Personnel monitoring

a. Personnel dosimetry provided to appropriate personnel in compliance with RHA 3.17.

11. Survey instrum ents

a. Survey instruments satisfy RHA 4.13.6.

b. Daily operability checks.

c. Calibration performed annually in accordance with RHA 4.8.3.

d. Records of calibrations maintained in accordance with RHA 4.8.3.

12. Operating Procedures

a. Commitment to provide copies to device operators and post copies at device console.

b. Comm itment to pro vide verba l, as well as written instruc tion to individ uals provid ing safety

checks.

c. Procedures sub mitted include following comm itments:

- Device, console, and treatment room secured when not in use or unattended.

228

- Only patient allowed in treatment room for medium/high dose rate afterloading device.

- When visitors are allowed for low and pulsed dose rate treatments, procedures shall be

established to insure the source is retracted into the shielded safe prior to entry of the

visitor(s) into the room and the maximum no. and length of visits allowed shall be

charted.

- Nursing personnel provided specific (written) instructions for patient care.

- Computer media used to load patient treatment parameters properly labeled, reused in

accordance with m anufacturer � s instructions.

- Survey of device and patient performed immediate ly following source retraction or

removal.

- Record of device and patient surveys maintained.

- Commitment to implement emergency procedures if source not fully retracted.

- Commitm ent not to co nduct treatm ents for which a decoup le or jamm ed source could no t

be remo ved expe ditiously.

- Authorized user and m edical physic ist or radiation safety officer pre sent during all

treatments using a medium, pulsed, or high dose rate afterloading device.

- Authorized user and m edical physic ist or radiation safety officer pre sent during all

treatments using a pulsed dose rate afterloading device or alternative commitment to

provide equivalent safety contro ls.

- Device operator present and available by telephone during treatments with low dose

afterloading device, authorized user and medical physicist or radiation safety officer

available for assistance.

d. Daily checks - descriptions submitted.

- Permanent radiation monitor tested with dedicated check source.

- Viewing an d intercom systems check ed for op erability.

- Source p osition indica tors checke d for ope rability.

- Treatment console operational function check and test of all indicators (lamps) and

displays.

- Visual and/or autoradio graphic inspection of app licators and connectors.

- Test of electrical interlocks for operability, records of test maintained.

- Commitment to suspe nd treatments if interlock system malfunctions.

- Record of daily checks maintained.

e. Monthly safety checks - description submitted.

- Backup battery check for afterloading device.

- Source positioning accuracy checked.

- Source position accuracy within +/- 1mm.

229

- Procedure submitted.

- Timer ac curacy and linearity.

- Measuremen t of source guide tubes and connectors.

-Records maintained.

f. Calibration of afterloading device.

- Names and qu alifications of individuals performing calibrations.

- Experience with dosimetry system.

- Description of method used to determine exposure rate.

- Record of calibration maintained and conte nt.

- Notification o f radiation safety o ffice or med ical physicist if mea sured outp ut differs by

greater than 5% of expected value.

Dosimetry System.

- Calibrated by NIST /AAPM - approved lab at 2 year intervals.

- Calibration record maintained.

- Calibration frequency - following source replacement and monthly thereafter.

- Determina tion of sourc e homog eneity.

g. Method of conducting source inventories in accordance with RHA 4.8.6.7

(autoradiography, source replacement, etc.).

13. Emergency P rocedures.

a. Established by authorized user and RSO or medical physicist, posted at treatment

console/area.

- Specify when to implement p rocedures.

- Confirmation copies of pro cedures provide d to device ope rators.

- Actions spe cified for eme rgency sour ce retrieval.

- Step-by-Step actions for progressive equipment failures, specific instructions on which

steps may be applicab le for given circumstances and wh o will perform these actions.

- Requirem ent to notify autho rized user an d medica l physicist or RS O immed iately of any

problem requiring implementation.

- Appropriate telephone numbers posted.

-Instructions for restricting and posting area.

- Emergen cy source re covery eq uipment.

14. Maintenance

a. Performed only by manufacturer �s representatives or individuals specifically authorized by

NRC or Agreement State.

230

b. Records maintained for all maintenance and repair.

c. Afterloadin g device insp ected and serviced at lea st annually.

- Inspections performed by individuals authorized by N RC or Agree ment States.

- Records of inspections maintained.

d. Licensee employee authorized to perform device maintenance and repair.

- Has letter or certificate from manufacturer documenting training.

- Letter of certificate specifies those functions which the named individual is qualified to

perform.

15. Waste disposal

a. Transferred only to authorized recipient (manufacturer).

231

MEDICAL UNIVERSITY OF SOUTH CAROLINA

Radiation Oncology

Radioactive Material Inspection

Inspection Date: ______________ Previous Inspection Date: ____________

I. License Review Yes No

A. Copies of MUSC Radiation Safety Manuals, Titles A and B, Title 10CFR and MUSC

licensed user authorizations on hand.

Comments:

B. Are radio active mater ials being used only by autho rized pers onnel and accordin g to

approv ed proto col.

Comments:

C. Are personnel being adequately monitored for exposure and the exposures reviewed by

managem ent.

Comments:

D. Are ancillary personnel credentialed and/or have received proper on the job training.

Comments:

E. Unusual occurrences, incidents or misadministrations since last inspection.

Comments:

232

Documents

Appendix K - Medical University of South Carolina