APPENDIX K DEPARTMENTAL QUALITY ASSURANCE PROCEDURES RADIATION ONCOLOGY PROSTRATE BRACHYTHERAPY PRESCRIPTION

Transcription

1 204 APPENDIX K DEPARTMENTAL QUALITY ASSURANCE PROCEDURES RADIATION ONCOLOGY PAGE PROSTRATE BRACHYTHERAPY PRESCRIPTION CALIBRATION CHECK OF THERAGENICS Pd-103 SEEDS PROCEDURE FOR SEED HANDLING PROCEDURE FOR DAY OF IMPLANT PROCEDURE FOR DAY FOLLOWING IMPLANT HDR TREATMENT RECORD AND PRESCRIPTION FORM HDR NUCLETRON OPERATING PROCEDURES HDR Ir-192 SOURCE EXCHANGE AND CALIBRATION PROCEDURES NUCLETRON HDR PATIENT TREATMENT CHECKS INTRACAVITARY BRACHYTHERAPY PRESCRIPTION BRACHYTHERAPY AND RADIOPHARMACEUTICAL TREATMENT CESIUM THERAPY RECORD PATIENT ROOM SURVEY CESIUM WARD RECEIPT NURSING PRECAUTIONS FOR PATIENTS RECEIVING BRACHYTHERAPY BRACHYTHERAPY SUMMARY SHEET CHECKLIST FOR MEDICAL APPLICATION OF HDR ONCOLOGY RADIOACTIVE MATERIAL INSPECTION SHEET

2 205 Medical University of South Carolina 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: Treatment Site: Dosimetric Objective: mci per seed Prostrate, other Gy to of PTV MD Signature Date: Oral Revision: Oral revision of Treatment Plan (Check 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 Treatment Site: mci per seed Prostrate, other Number of seeds recovered in Cysto: Total # of seeds Implanted: MD Signature Date:

3 206 Medical University of South Carolina CALIBRATION CHECK OF THERAGENICS Pd-103 SEEDS DATE: RO#: P.O.#: PATIENT: IMPLANT DATE: DR: Milito MANUFACTURER: Theragenics Corp. LOT#: MODEL: 200 MANUFACTURER 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 44E Brachytherapy Programmable Electrometer with CNMC 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 # Rdg Pd-103 Setting *** Calibration Factor* (mci/rdg) Calc. Activity (mci) Calibration Factor (Pd-103)** Calc. Activity (mci) Percent Error % #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #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:

4 207 Medical University of South Carolina 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 in order to reduce the number of seeds in any group that must be recounted in case of error or confusion. Do all counting on the Plexiglas tray provided. Place every tenth seed into the calibrator and count. 2. A minimum of least 10 seeds must be placed in the calibrator and calibrated one at 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 the right 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 work on. a. Seeds have a tendency to skitter when they fall on a hard smooth surface. 2. Assemble and arrange the vacuum-assisted seed loader on the working tray with the pump on your strong side (right-handedness Vs. left-handedness). The power distribution cord and switch should be on the side nearest the door for easy access by the person helping to count. 3. The following instruments should be at hand: a. Special seed handling forceps b. Special seed handling hemostat c. Modified sponge forceps (11-inch) d. Modified curved forceps (11-inch) e. Metal ruler f. Spare pig g. Stainless steel bowl (3-inch) h. Slip shield set with wrench i. Eberline G-M counter with pancake probe 4. The following materials are needed: a. The appropriate number of needles as determined by the computergenerated plan supplied by the physician or physicist plus one unopened package of 5 needles.

5 208 Medical University of South Carolina 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 careful NOT 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 s instructions. 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 be labeled with the seed per needle count. 6. Fill out the radioactive materials tag and carry the set to Sterile Processing (first floor of Children s Hospital) to be GAS sterilized. Log in the seeds in the Sterile Processing logbook. 7. Survey the preparation area for any lost or stray seeds. 8. Store all equipment and materials in their proper place.

6 209 Medical University of South Carolina PROCEDURE FOR DAY OF IMPLANT 1. Load the following supplies on the utility cart marked RAD ONC A. Sterile Supplies: 1. Package with L block 2. Package with needle array block, template, seed and needle manipulation block 3. Genesis Pan with needle set and seeds B. Items to be Flashed upon arrival at OR: 1. Special seed handling forceps 2. Special seed handling hemostats 3. Lead pig marked OR 4. Modified sponge forceps 5. Modified curved forceps 6. 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 that you are using. F. Two packages (2 needles each) of Prostrate Fixation Needles. 2. Change to scrubs and be at OR minutes prior to patient s scheduled time. A. Scrubs including cap and mask are required but not normally required to scrub hands and 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 along side of the needle block. However, the exact position will depend on the OR that you are in. 2. Open the square needle package and place spare needles in the needle seed manipulation block on the L block PRN. 3. The needle set must be opened and placed on the table for the doctor who will be scrubbed and gowned.

7 210 Medical University of South Carolina PROCEDURE FOR DAY OF IMPLANT CONT. D. Read the needle distribution plan to the doctor and double check the location and seed count 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, Do Not 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 precautions necessary 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. Count and 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 can commence. G. INVENTORY ALL YOUR INSTRUMENTS; place on the utility cart and return to Radiation 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 equipment to Urology. b. Pick up the template the next day at Module 11.

8 211 Medical University of South Carolina 4. When the procedure is finished in the OR: PROCEDURE FOR DAY OF IMPLANT CONT. A. Be sure to have the urology resident put in his orders to have RAD ONC notified when the 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 the room. a. This pig is for Nursing to use if they should find a seed. 3. Place Nursing Precautions for Patients receiving Radioactive Brachytherapy for 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 Survey Form. C. In the : 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 of needles, how and by whom they were placed. 2. Complete the log book located in the Dosimetry Office.

9 212 Medical University of South Carolina PROCEDURE FOR DAY FOLLOWING IMPLANT A. When Nursing notifies the, the room must be surveyed. 1. Using the G-M counter with the pancake probe, survey the patient s room, linen, trash and 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 sign from 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 the room 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 the original 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 was surveyed, clear and ready for normal occupancy. D. Pick up the template from Module 11 and prepare your sterile packs for the next procedure.

10 213 Medical University of South Carolina 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 the procedure 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 be processed in an horizontal position. The external package cover will have a Radioactive Materials tag attached. Loaded needles should not be placed in the General Pickup bins when finished, they should be held in 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

11 214 Medical University of South Carolina HDR TREATMENT RECORD AND PRESCRIPTION FORM HDR-100 PATIENT: RT#: PRESCRIPTION FORM DIAGRAM 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: 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: 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 DATE FRACTION NO: ISOTOPE Ir-192 Ir-192 Ir-192 Ir-192 Ir-192 Ir-192 No. OF CATHETERS APPLICATORS DOSE THIS FRACTION (cgy) SOURCE STRE NGTH (Ci) No. OF DWELL POINTS TOTAL DWELL TIM E (Sec) PHYSIC S REVIEW (Physicist) TREATMENT AUTHORIZED BY (MD) TOTAL DOSE (cgy) TO DATE DELIVERED BY (Therapist) mr/hr POST TREATMENT SPECIAL PHYSICS REPORT MD REVIEW/DATE

12 215 Medical University of South Carolina NUCLETRON OPERATING PROCEDURES The following operating procedures will be used in setting up and treating patients with the Nucletron mhdr unit in Treatment Rooms 1, 2, and When the treatment is scheduled for one of the treatment rooms, the mhdr unit will be moved from 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 the Physics/Engineering staff. 3. The Nucletron control console cabinet will be moved to the treatment room console area and connected 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 the therapy room. 15. The therapist will perform a radiation survey of the patient after the patient is removed from the treatment room and log the results in the patient treatment form. A copy of this form will be photocopied 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.

13 216 Medical University of South Carolina HDR Ir-192 SOURCE EXCHANGE AND CALIBRATION PROCEDURES The Ir-192 source used in the Nucletron Microselectron HDR is changed approximately every three months. Following each source exchange, the new source is calibrated to determine its true activity by one of the staff medical physicists. The entire procedure for the source exchange and calibration is given below. 1. Receiving New Source Nucletron notifies the Section of Medical Physics as to the date the new source will arrive. Once the source reaches the department, it is placed in Room 165Q. Within three hours of arrival, a wipe test is done of the source container to detect any removable contamination. (Wipes can be obtained from the MUSC Radiation Safety Office. Physicist can wipe the surface of the HDR source container and submit the wipe in an envelope to RSO for counting.) The container is not to 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 deposits it in the empty pig which is kept in the Room 165Q. With the old source out, preventive maintenance is carried out by the engineer on the unit. Upon completion of this preventive maintenance, the engineer installs the new source in the unit. The old source is packed in its shipping container and kept in Room 165Q until pickup. To arrange for the pickup of the old source the physicist in charge of the source exchange contacts Nucletron ( ask for RSO) and informs (via fax or phone) them of the transportation index (T.I.) Of the source, the decayed activity of the source and the source number (there is a form in the HDR Source Exhcange file for faxing). The appropriate documents are then sent to the physicist by Nucletron and 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 physicists calibrates the source to determine its actual activity. The steps required to perform the calibration are the following. a. Warm up the Atom Lab calibrator for at least 30 min. prior to making calibration measurements. 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, length 995 mm, dwell time 60 sec and record the electrometer reading in nanoamp. In the HDR calibration form. Repeat this 3 more times. Using these measurements, and the calibration factors of the well chamber and electrometer, the source activity is determined. With the calibration setup timer linearity is also checked by taking electrometer readings for different dwell times eg. 30, 60, 120 and 180 sec. and plot the electrometer readings against the dwell times.

14 217 Medical University of South Carolina 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 planning computer program. 4. Documentation: The following documents are kept on record (in the HDR Source Exchange Doc. Log book) for each source exchange. 1. The Certificate for Sealed Source which comes with each source from Mallinckrodt Diagnostica. 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, and timer 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 decayed activity. 12. Wipe Tests results for outgoing source.

15 218 Medical University of South Carolina NUCLETRON HDR PATIENT TREATMENT CHECKS PATIENT: R.O# DATE: TIME: TREATMENT PRESCRIPTION: cgy AT AM PM APPLICATOR: #CATHETERS: SPECIAL NOTES: A. PRE-TREATMENT CHECKLIST: (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 CHECKLIST: 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 Survey meter readings: Eberline E-120, SN: ; check Source Reading: (x1 Scale): 9. Patient Surv ey Readings: surface of patient: ; mr/hr at 1 foot from patient: CHECKED BY: RT(T); DATE: RADIATION THERAPIST

16 Medical University of South Carolina 219 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 Source # Isotope Source Strength (mgraeq) Tandem/ Vag. Cylinder Left Ovoid Right Ovoid 1 Cs Cs Cs Cs-137 Size = 5 Cs Cs-137 Total Time (h) Mg-h Total mg-h Time in Day in Date in Isotope: Tot. Strength: mgraeq Rx Approved by: Date: Time out Day out Date out Rx Revised: Implant Removed at: Time Date: by Total Tx Time hrs. Tx delivered as Prescribed:, MD MD Sign:, MD Date: Date:

17 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 Sources to be used verified by: a. person 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

18 221 CESIUM THERAPY RECORD MEDICAL UNIVERSITY HOSPITAL 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 of application Proposed Time of Removal date signature Total Amt. Cesium mg. date signature No. Mr. Size mm. Duration hrs. Proposed Dose mgrs. Filter mm. Pt. Linear Intensity Actual Time of Removal date signature Total Time Applicator Was in Place Calculated Tissue Dosage: (gamma r & mg hrs) Diagram & Remarks:

19 222 MEDICAL UNIVERSITY OF SOUTH CAROLINA PATIENT ROOM SURVEY (Name Plate Stamp) PATIENT: ROOM: am/pm on am/pm on Total hours: By: Total amount of used: mgm-ra-equiv Source #1: #2 #3 #4 #5 #6 Radiation Readings in Room: (mr/hr) at Bed Location: (See Diagram Below for appropriate Room Bed Layout to Select)

20 223 MEDICAL UNIVERSITY OF SOUTH CAROLINA 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

21 224 MEDICAL UNIVERSITY OF SOUTH CAROLINA NURSING PRECAUTIONS FOR PATIENTS RECEIVING RADIOACTIVE BRACHYTHERAPY PATIENT: PATIENT #: ROOM #: was administered mg-ra-eq of on (Date:) at (Time:) AM/PM By: 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 brachytherapy patient 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 stand behind 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 or intentionally removes the source(s) from his/her body, IMMEDIATELY CONTACT THE RESIDENT ON DUTY. He/She will place the source(s) in a portable shielded carrier. UNDER NO CIRCUMSTANCES SHOULD YOU PICK UP OR TOUCH THE SOURE(S). In the event of lost, damaged, or ruptured source(s), CONTACT THE ABOVE PHYSICIAN AND THE MUSC RADIATION SAFETY OFFICER (2-4255). Stop all traffic into or out of the area and turn 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 the survey shall be noted in the patient s chart and the MUSC Cesium Ward Receipt form. The room also shall be thoroughly surveyed before release for use. 5. Patient excreta may be disposed of in the normal manner unless noted otherwise in these instructions: 6. Nursing personnel attending the patient may be required to wear film badge monitors at the discretion of the MUSC Radiation Safety Officer (RSO). If issued by the RSO, the film badge monitor is to be worn either at waist level, on a pocket, or on the collar. Film badge monitors are to be worn ONLY by the individual to whom they are issued. Contact the RSO (2-4255) if additional monitors are needed. 7. Only designated residents, radiation oncology residents, attending radiation oncologists, radiation physicists, radiation oncology dosimetrists, radiation therapists, or RSOs shall remove brachytherapy 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 the Centrex Operator (2-2123) for emergency phone numbers or pager numbers if no answer at either office.

22 225 MEDICAL UNIVERSITY OF SOUTH CAROLINA BRACHYTHERAPY SUMMARY SHEET PATIENT: #: DIAGNOSIS: TREATMENT DESCRIPTION: TREATMENT SITE: APPLICATION SITE: 1. Fletcher: ; 2. Delclos: ; 3. Seeds: 1. Intracavity 2. Interstitial SOURCES: 1. Cesium: ; 2. Other: LOADING: (Cesium) Tandem Ovoids EXTERNAL BEAM: 1 2 1) 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:

23 226 CHECKLIST FOR MEDICAL 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 radioactive 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 ) 7. Did applicant submit information concerning their personnel training program: Authorized Users and Device Operators a. Subjects to be included in initial training.

24 227 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 information concerning their facilities and equipment: a. Dedicated Room (High, Pulsed, and Medium Dose Date) - Annotated drawing. - Scale. - Room numbers (Room Identification). - Shielding material. - 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 suspend treatment if interlock malfunctions. - Area controls (signs, locks, visible/audible alarms). - Other radiation-producing devices. - Method to prevent dual operation. - Security of console keys. d. Permanent radiation monitor. - Visible notice on entry.

25 228 - Back-up power sup ply. - Operability check. - Emergency entry provisions. - Commitment to promptly repair/replace. 9. Compliance with restricted/unrestricted area radiation level limits. a. Calculations of maximum radiation levels for restricted /unrestricted areas to dem onstrate compliance with RHA 3.5 and 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 Exemption from RHA Need for exemption specified. - Duration of exemption specified. - Program to access and control dose. b. Survey program to demonstrate compliance with RHA Survey of device following source replacement or location of device changes. c. Device label in accordance with RHA Personnel monitoring a. Personnel dosimetry provided to appropriate personnel in compliance with RHA Survey instrum ents a. Survey instruments satisfy RHA b. Daily operability checks. c. Calibration performed annually in accordance with RHA d. Records of calibrations maintained in accordance with RHA Operating Procedures a. Commitment to provide copies to device operators and post copies at device console. b. Commitment to provide verba l, as well as written instruc tion to individuals providing safety checks. c. Procedures sub mitted include following comm itments: - Device, console, and treatment room secured when not in use or unattended.

26 229 - 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 manufacturer s instructions. - Survey of device and patient performed immediately 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 conduct treatments for which a decouple or jammed source could not be removed expe ditiously. - Authorized user and medical physicist or radiation safety officer present during all treatments using a medium, pulsed, or high dose rate afterloading device. - Authorized user and medical physicist or radiation safety officer present during all treatments using a pulsed dose rate afterloading device or alternative commitment to provide equivalent safety controls. - 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 and intercom systems checked for operability. - Source position indicators checked for operability. - Treatment console operational function check and test of all indicators (lamps) and displays. - Visual and/or autoradiographic inspection of applicators and connectors. - Test of electrical interlocks for operability, records of test maintained. - Commitment to suspend 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.

27 230 - Procedure submitted. - Timer accuracy and linearity. - Measurement of source guide tubes and connectors. -Records maintained. f. Calibration of afterloading device. - Names and qualifications of individuals performing calibrations. - Experience with dosimetry system. - Description of method used to determine exposure rate. - Record of calibration maintained and content. - Notification o f radiation safety o ffice or medical physicist if measured 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. - Determination of source homogeneity. g. Method of conducting source inventories in accordance with RHA (autoradiography, source replacement, etc.). 13. Emergency Procedures. a. Established by authorized user and RSO or medical physicist, posted at treatment console/area. 14. Maintenance - Specify when to implement procedures. - Confirmation copies of pro cedures provided to device operators. - Actions specified for emergency source retrieval. - Step-by-Step actions for progressive equipment failures, specific instructions on which steps may be applicable for given circumstances and who will perform these actions. - Requirem ent to notify autho rized user and medical physicist or RS O immed iately of any problem requiring implementation. - Appropriate telephone numbers posted. -Instructions for restricting and posting area. - Emergency source recovery equipment. a. Performed only by manufacturer s representatives or individuals specifically authorized by NRC or Agreement State.

28 231 b. Records maintained for all maintenance and repair. c. Afterloading device insp ected and serviced at least annually. - Inspections performed by individuals authorized by N RC or Agreement States. - Records of inspections maintained. d. Licensee employee authorized to perform device maintenance and repair. 15. Waste disposal - Has letter or certificate from manufacturer documenting training. - Letter of certificate specifies those functions which the named individual is qualified to perform. a. Transferred only to authorized recipient (manufacturer).

29 232 MEDICAL UNIVERSITY OF SOUTH CAROLINA Radiation Oncology Radioactive Material Inspection Inspection Date: Previous Inspection Date: I. License Review Yes No Comments: A. Copies of MUSC Radiation Safety Manuals, Titles A and B, Title 10CFR and MUSC licensed user authorizations on hand. Comments: B. Are radioactive materials being used only by authorized personnel and according to approved protocol. 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.

30 233 F. Comments or R ecommendations: II. Records Review Y N A. Current Inventory. B. Receipt and dispo sal records. C. Shipment documentation. D. Patient treatment documentation and dosimetry calculations. E. Facility Surveys. F. Adequate monitoring instrumentation. G. Instrumentatio n calibrated and functioning properly. H. Required leak tests performed and recorded. I. Are treatme nt facilities adequate. (Viewing system, alarms, shielding, etc.) J. Posting of required warning signs, NTE and list of authorized users. K. Are facilities properly secured and public access restricted for both HDR and implant sources. L. Comments and Recommendations: III. Operating Procedures A. General 1. Nursing personnel provided with specific (written) instructions for patient care? 2. Survey of device/implant and patient performed immediately following source retraction or removal? 3. Records of device and patient surveys maintained? 4. Quality assurance plan and records? B. Daily checks performed 1. Permanent radiation monitor tested with dedicated check source? 2. Viewing and intercom system checked for operability prior to use? 3. Source p osition indicators checked for operability? 4. Treatment console operational function check and test for all indicators (lamps) and displays?

31 Visual and/or autoradiographic inspection of applicators and connectors? 6. Test of electrical interlocks for operability? C. Monthly checks performed 1. Backup battery check for afterloading device? 2. Source positioning accuracy check? a. Source position accuracy within +/- 1 mm? 3. Timer ac curacy and linearity? 4. Measurement of source guide tubes and connectors? D. Calibration of afterloading device 1. Following source replacement and monthly thereafter? E. Emergency procedures 1. Posted at treatment console/area? 2. Actions spe cified for emergency source retrieval? 3. Emergency source equipment available? 4. Instructions for restricting and posting area? F. Maintenance 1. Afterloading devices inspected and serviced at least annually by qualified personnel? G. Comments and Recommendations: IV. A. Items of Noncompliance: B. Management Discussion:

32 235 C. Comments: Inspector: Inspection Reviewed by: Date: Date: