1.0 Revision history 001 13 January 2015 002 19 February 2015 003 01 June 2015 Finalized compiled version of brachytherapy audit checklist developed Authors edits incorporated and version circulated to beta sites Beta sites comments addressed and checklist finalized by authors 2.0 Purpose and scope of document Department leads, administrators, and physicists will use these guidelines to determine if their quality and document practices meet appropriate standards. Please note, the listed checklist items have not been vetted for individual agreement state or master material license requirements. 3.0 Definitions AAPM - American Association of Physicists in Medicine ACR - American College of Radiology AMP - Authorized Medical Physicist CMD - Certified Medical Dosimetrist CQI - Continuous Quality Improvement CT - Computed Tomography DVH - Dose Volume Histogram GEC – The Groupe Europeen de Curietherapie IAEA – International Atomic Energy Agency LDR – (Manual) Low dose rate brachytherapy OAR - Organ at Risk PTV – Planning Target Volume QMP – Qualified Medical Physicist RSO – Radiation Safety Officer SS – Severity Score TEDE - Total Effective Dose Equivalent TPS - Treatment Planning System ABS – American Brachytherapy Society ADCL - Accredited Dosimetry Calibration Laboratory AU - Authorized User (Physician) CME - Continuing Medical Education CRCPD - Conference of Radiation Control Program Directors CTV - Clinical Target Volume ESTRO – European Society for Radiotherapy & Oncology HDR – High dose rate brachytherapy IC – Importance Criteria NRC – Nuclear Regulatory Commission PR – Primary Responsibility QA - Quality Assurance RPC - Radiological Physics Center SDE - Shallow Dose Equivalent SSDR – Sealed Source Device Registry TG - Task Group 4.0 Policies 4.1 Quality procedures and documented records will be compared against the following table. 4.2 Discrepancies will be resolved with the Quality Management Program. 5.0 Preparation: Assemble the following tables from the listed documents prior to the start of the audit Reference Tables Report of AAPM TG 56 V, VI, and VII AAPM Low Energy Brachytherapy Source Calibration Working Group I and II 6.0 Definition of importance criteria (IC) “1” is a non-compliance that (by itself) carries minimal potential for a treatment variance. “2” is a non-compliance that carries with it a potential for a treatment variance. "3" is a non-compliance that could lead to a regulatory violation with minimal potential of causing harm or a medical event. "4" is a non-compliance that carries a potential for serious harm or a medical event. 7.0 Scoring Review each line item and assign a non-compliance severity score (SS) to each item. Scoring is based on a scale of 0 – 3 as follows: “0” is a line item that was fully accomplished and appropriately documented; “1” is a line item that was fully accomplished but not appropriately documented; “2” is a line item that was only partially accomplished or where multiple deficiencies in execution and documentation were noted; “3” is a line item that was not accomplished or documented in any way. To determine the composite audit score for an individual program, calculate the sum total of the product of the criteria importance by the non-compliance severity for each line item. Non-compliance should be addressed beginning with items with the highest product. Table 1. A comprehensive brachytherapy audit checklist that may be used prior to external reviews or as a part of the institutions CQI program. The right most columns labelled “SS” and “IC x SS” are intended for the user to complete during their program review. Item PR IC (1 – 4) 1 Admin 3 2 Admin 4 3 Admin 4 4 Admin 1 Standard / Criteria RSO qualifications shall match agreement state or NRC requirements as applicable. Credentials compared with current requirements, with written proof of qualifications, and appointment on file for review. AU physician qualifications shall match agreement state or NRC requirements as applicable. Credentials compared with current requirements, written proof of qualifications and state licensure shall be identified and on file for review. AU should be board certified, and under maintenance of certification. AMP qualifications shall match agreement state or NRC requirements as applicable. Credentials compared with current requirements, written proof of qualifications shall be identified and on file for review. AMP should be board certified, and under maintenance of certification (if applicable). Qualifications of other staff should be appropriate: 1) medical dosimetrist who performs brachytherapy planning should be a CMD, and 2) radiation therapist participating in Reference 1 1-5 1-7 5 SS (0 – 3) Item Score: IC x SS brachytherapy should be ARRT certified.1 5 Admin 2 6 Admin 4 7 QMP 4 1 2 All members of brachytherapy team should have appropriate procedure specific training or competency on file. This may include the following: 1) AU 2) AMP 3) medical dosimetrist 4) radiation therapist 5) nursing staff.2 New hardware (e.g., a remote afterloader), major software, and new modalities shall be commissioned prior to use. Commissioning may include the following elements: 1) a written plan and scope of clinical implementation addressing professional society reports, manufacturer's acceptance testing, manufacturer's recommendations, and relevant literature; 2) policies and procedures developed during commissioning, including quality assurance methods; 3) a record that relevant training was performed; 4) test details including equipment, dates, methods, results, and name of person performing each test; 5) approval by the director of clinical physics and/or the medical director of radiation oncology; 6) review and approval by the CQI committee prior to clinical implementation; 7) a review by a designated outside expert for new clinical modalities and procedures when possible; and 8) follow-up items with appropriate follow-up demonstrated. Commissioning and/or acceptance testing of computerized TPSs used for dose calculations shall include verification of: 1) geometric accuracy of inputs (CT, ultrasound, digitizer, etc) and outputs (printouts, images); 2) source specific input parameters; 3) accuracy of source positions as determined from imaging; 4) dose, dwell time, and treatment time; 5) accuracy of isodose lines, DVH's, graphic displays, and plan outputs; 6) accuracy of point doses, source positions, and isodoses under multiple orthogonal rotations; 7) accuracy of transfer of coordinates and delivery parameters to the treatment delivery unit; 8) optimization software. If a model-based dose calculation algorithm (MBDCA) is commissioned, heterogeneity corrected doses should be compared with TG-43 dose calculations. Please note Thomadsen et al.[5] recommends a review of the qualifications of surgeons, if applicable, as well. Please note Thomadsen et al.[5] recommends a review of procedure specific training of surgeons, if applicable, as well. 5 6-9 1,8,10 8 Admin 1 9 Admin 1 10 Admin 1 11 RSO 3 12 Admin 1 13 QMP 3 14 QMP 3 15 RSO 3 16 QMP 1 17 QMP 3 18 RSO, QMP 3 19 QMP 4 Policies and procedures should: 1) be controlled so that only the latest, formally reviewed and approved revision is readily accessible; 2) be uniquely titled/identified and have a revision date and effective date; 3) list the primary author and approving authority; 4) contain a revision history, purpose and scope (or similar categories); 5) describe equipment, frequency of required actions/tests, responsible parties, notification paths, and action levels. Clinical worksheets, and checklists should: 1) be controlled so that only the latest, formally reviewed and approved revision is readily accessible; 2) be uniquely titled/identified and have a revision date and effective date; 3) include spaces for the date and patient information (if applicable); 4) include spaces where the individuals completing and approving the document can sign. Emergency contact information (e.g, AMP, AU, RSO, and vendor, if applicable) shall be posted. Staff shall know the identity of RSO and know how to contact them. License shall list 1) all sources that are in use, 2) maximum permissible source activity, and 3) location of use and storage sources. For HDR, the maximum permissible source activity listed on the license shall allow for the presence of multiple sources near/during source exchange. Sealed source and device registry (SSDR) certificate(s) should be available for each source listed on license. Source(s) used in accordance with the SSDR. Shielding design shall be approved and available. If multiple radiation producing devices housed in a single treatment room, ensure either interlocks or administrative controls allow only one to be operated at a time. 11 Shielding should be reassessed when new brachytherapy procedures are added or patient load increases beyond initial, anticipated workload. Appropriate amendments shall be made to the license if changes are made to the program or involved personal. Before using a newly available brachytherapy sealed source in clinical practice, at least one experimental and one model based (e.g., Monte Carlo) study should be used to validate dosimetric parameters. Records of maintenance for major equipment repair should include the name of the person performing service, date, description of repair, and signature of physicist authorizing return to service. Calibrated survey instrument shall be available, two points per scale up to 10 mSv/hr range, calibrated annually and after repair, with calibration date noted on instrument. Well chamber shall be calibrated biennially or after repair; calibration is NIST traceable 14 11 8 1,12 1,12 2,13 1 15 1,16 1,16 1,6-9,17 20 RSO, QMP 3 21 RSO, QMP 3 22 QMP 3 23 Admin 3 24 RSO 3 25 Admin 1 26 RSO 3 27 Admin 3 or from a laboratory accredited by AAPM. Constancy shall be checked with long-lived source initially, before each use, and after repair. Leakage shall be checked each use. Well chamber reproducibility, linearity, time and temperature dependence should be tested annually. (Alternative to calibration: Can follow inter-comparison method described in 10 CFR 35.630.a.2.) Emergency procedures shall be reviewed and documented, should include procedures for handling leaking and lost sources, patient expiration with sources, excised tissue(s) with sources or radioactive material, and patient non-compliance. If a patient cannot be released under 10 CFR 35.75, then the patient shall be placed in an appropriate individual room labeled with a radioactive materials sign, visitor's instructions shall be immediately available or posted, and emergency response equipment shall be immediately available. A procedure shall be in place to immediately notify the RSO and AU if the patient has a medical emergency or dies. Quality assurance (QA) program shall be developed, implemented, and overseen by a QMP. Documentation should be available that demonstrates an annual brachytherapy program review by a QMP or AU with appropriate follow up, as well as periodic review of the program by the medical director and administration. The facility shall perform an annual review of the radiation protection program. Initial and annual retraining of staff shall be performed and documented. Includes radiation safety instruction, safe operation of equipment, treatment techniques, emergency procedures, operation of the TPS (if applicable) and new developments. Annual radiation safety instruction must include size and appearance of sources, safe handling, shielding, patient and visitor control, and when/how to notify RSO. Instructions to workers shall be available and posted (e.g., NRC Form 3.) CQI program and committee should be in place. CQI committee should approve new treatment methods and modalities; review variances, incidents and accidents (to include any with patient injury); review dose deviations from the prescription greater than 10%; review unplanned treatment interruptions; review unusual/severe complications of treatment and unexpected deaths. Minutes of each meeting maintained for review. Radiation exposure monitoring and protection program shall be in place for staff expected to enter a high/very high radiation area and/or receive > 10% of any of the following: 0.05 Sv TEDE, 0.5 Sv SDE, 0.15 Sv to lens, or any declared pregnant workers expected to receive > 0.001 Sv. Additional monitoring/precautions in place for declared pregnant workers to limit embryo/fetal dose to < 0.005 Sv. All staff shall be wearing a personal dosimeter as required by the program. A policy and/or procedure shall be in place to report medical events and reportable doses to an embryo/fetus in accordance with agreement state and NRC regulations. Policy 1,6,18-21 1 1,6,7,9,13,22 1,6,7,12,13,23 23 3,9 13 1,13,16 defines a medical event, delegates responsibilities, lists time limits for reporting, and describes reporting requirements to patient, risk management, state, NRC, vendor, and FDA as applicable. Staff should be trained on the policy. Policy should be compliant with agreement state or NRC regulations. 28 Admin 1 29 RSO, QMP 3 30 RSO, QMP 3 31 QMP 3 32 QMP 2 33 RSO, QMP 3 34 QMP 3 35 Admin, QMP, AU 2 Measures shall be in place to backup patient treatment records. If original records are lost, reproduced records should be attainable within 24 hours. Procedures for ordering, receiving, opening, and returning radioactive material shall be documented and followed. Package external surfaces shall be monitored for contamination and radiation levels within 3 business hours after receipt. If sources shipped from facility, DOT requirements shall be met to include package labeling and marking, preparation of shipping papers, and DOT training every 3 years for shipper. Source inventory shall be conducted semi-annually and include radionuclides, quantity, model, serial number (if applicable), location, date, and name of individual conducting the inventory. License limits shall not be exceeded and any missing sources followed up on according to agreement state or NRC regulations. Any imaging modality used for treatment planning shall have an adequate QA program in place, consistent with national guidelines. For each modality, review the overall program and ensure procedures are reasonable, appropriate annual testing was performed, and appropriate QA was performed the day of the procedure. Sources shall be tested for leakage at initial use and at intervals not to exceed 6 months. The test shall detect the presence of 185 Bq (0.005 μCi) of radioactive material. If > 0.005 uCi of removable contamination found then source is withdrawn from use, repaired or disposed of appropriately, and a report per 10 CFR 35.3067 is filed within 5 days. Exceptions: Sources with a half-life of less than 30 days, gases, <= 3.7 MBq (100 μCi) of beta or gamma-emitting material, <= or 0.37 MBq (10 μCi) alpha-emitting material, seeds of iridium-192 encased in nylon ribbon, and sources stored and not being used. Decay corrections should be applied anytime the source strength changes by 1% or greater. Written procedures should be documented and address the specifics of how to accomplish: 1) written directive, 2) daily treatment record, 3) daily QA, 4) a pre-treatment plan and chart quality review, 5) documentation of the simulation, implant geometry, and treatment chart 6) a computer dwell-time validation calculation (if applicable). A written protocol for each commonly treated disease site should be available and include technique, important dose volume constraints (if applicable) and prescriptions that are consistent with national/international guidelines. 24 8,13 25,26 1 19,27-29 1 1 6,8,17 36 AU 2 Initial clinical evaluation of patient should include a history and physical and review of relevant medical and diagnostic reports. Diagnosis and stage should be documented. 3,6,30 37 AU 1 3,6 38 AU 1 39 AU 4 40 4 41 AU/Medical Staff AU, QMP 42 QMP 4 43 AU 3 44 QMP, AU 4 45 AU, QMP 1 46 QMP 4 Goal of treatment and options should be discussed with patient and/or family members and documented. Informed consent shall be appropriate and complete. If patient is part of an IRB approved-study, study-specific consent is documented. Pre-procedure pregnancy screening policy shall be in place. If a procedure precludes treatment of a pregnant patient then negative pregnancy test, hysterectomy, postmenopausal amenorrhea > 2 years, or premenarche with age less than 10 years shall be confirmed prior to administration. A time out shall be performed prior to implant and/or treatment to confirm correct patient identity, correct site, and correct procedure matching the prescription. The appropriate applicator shall be selected, placed, appropriately verified and documented. Positioning of applicator relative to anatomical landmarks and/or tissue of interest shall be verified via localization images (e.g., x-ray, CT, MR, US) prior to treatment. Adjustments made if necessary. Placement performed by AU or physician under the supervision of an AU. Compatibility of applicator with imaging modality (especially MR) shall be confirmed prior to planning simulation. Written directive shall be completed, signed, and dated before treatment. Directive shall include the patient’s name, radionuclide, site, total dose or source strength, dose per fraction and number of fractions (if applicable), exposure time (if applicable), source position (if applicable), number of sources and total source strength (if applicable, and after implantation but before procedure is complete) and any information required for the given modality or applicable regulatory agency (i.e., local/state/NRC). An independent check shall be performed and documented by the QMP to ensure the written prescription is fulfilled and the sources and source loading (if applicable) match the physician approved treatment plan. This should include a verification of all critical brachytherapy treatment parameters and a second check of the dose calculation. The check method should be formalized and the results of the check documented in the patient chart. If applicable, include a confirmation that the appropriate atlas/library plan and/or applicator model selected. Complete dosimetry records should include a description of the sources, the technique or pattern used, dose rate, implant time, source strengths, prescribed dose, dwell positions with step sizes (if applicable) and reference positions for each applicator (if applicable), isodose distributions in appropriate planes through the applicator, DVHs (if applicable), proof of an independent check, and delivered dose. Patient, staff (if applicable), and treatment area shall be surveyed after implant and after 4 31,32 33 17,34 6,8,30,35 1,3 3,6,7,9,17 3,6-9 1,6 47 AU, QMP 3 48 AU 3 49 AU 2 50 RSO 3 51 QMP 4 52 AMP 4 53 AMP 2 54 AMP 2 55 AMP 3 56 AMP 4 3 source removal/retraction to ensure accountability for all sources. Release criteria (TEDE to another individual < 5 mSv) shall be met as applicable. Instructions shall be provided to patients if TEDE to another individual > 1 mSv is likely. If a nursing infant or child could exceed 1 mSv TEDE the instructions shall include guidance on interruption of breast feeding and consequences of failure to follow guidance. Documentation provided to patient should include information pertaining to the implanted radioactive isotope, and clinic contact information in the event a security alarm is triggered. If treatment modifications are required, modifications shall be documented, and signed/dated by the AU. A patient undergoing treatment should be monitored by a physician on a weekly basis (with the exception of permanent implants), and records should be maintained. Treatment summary should be completed at the conclusion of therapy, and a follow-up plan documented. Sources shall be properly disposed of or transferred to another authorized and licensed recipient. Decay in storage only used for materials with half-lives < 120 days, and decayed sources are disposed of only after the surface exposure has been confirmed as indistinguishable from background and radiation labels removed. Records of transfer audited for completeness. A TPS QA program shall be developed and conducted annually or following TPS upgrades. HDR: Check of source calibration shall be performed before first medical use, following repair, following source exchange, and quarterly by an AMP. Calibration of HDR source shall agree with vendor’s calibration to within 5%. The result should be documented at unit with strength, date, and name of AMP. Output shall be corrected at intervals consistent with 1% physical decay. Independent second check should be performed. HDR: Commissioning of remote afterloader systems shall include the elements shown in Table VII of the report of AAPM TG56. HDR: Annual testing of remote afterloader systems should include the elements shown in Table VII of the report of AAPM TG56. HDR: Quarterly testing shall include source positioning accuracy (to within 1mm), source retraction with battery backup, length of transfer tubes, timer accuracy and linearity, applicator length, function of the transfer tubes and applicators, and an autoradiograph. Quarterly testing of remote afterloader systems should include the elements shown in Table VI of the report of AAPM TG56.3 HDR: Daily testing of remote afterloader systems should include the elements shown in Table V of the report of AAPM TG56. Testing shall include, per 10 CFR 35.643, a check 1 1,6 3,32 1,13 1,36 1,7 8 8 1,8 1,8 There is a footnote to Table VI regarding complete facility survey which does not appear to be required by current NRC regulations. 57 AMP 2 58 AMP 3 59 AMP 4 60 AMP 4 61 AMP 3 62 Admin 3 63 RSO 3 64 QMP 4 65 QMP 4 of door interlocks, exposure lights, viewing and intercom system, emergency response equipment, radiation monitors, timer accuracy, day/time on console, and source activity defined in the control computer. HDR: A pre-treatment check of each applicator should be performed to include integrity, completeness, sterilization, function, dimensions, and positional accuracy. HDR: The AMP shall survey the afterloader with the source retracted to ensure surface radiation levels do not exceed those stated in the SSDR. Surveys performed at installation and after repair that could expose the source, reduce the shielding around the source, or compromise the radiation safety. Records maintained for duration of unit. HDR: New devices or applicators shall be evaluated with respect to integrity, suitability of use with source(s), and effects on dose distributions. Applicator radiograph/autoradiograph shall be acquired and the device physically inspected prior to use. Annual radiographs and inspections should be performed. HDR: Remote afterloader safety systems shall include door interlock that forces source retraction if tripped and requires a reset, camera for continuous viewing, intercom, and radiation monitors. Console, keys, unit, and room secured when not in use. Only authorized individuals are allowed in room during treatment preparation and in the event of an emergency. HDR: Procedures for responding to abnormal and emergency situations shall be developed, implemented, and immediately available at console. Procedures must include who is responsible for equipment failures and their contact information, and procedures for restricting access/posting. Emergency response kit at console should includes danger sign and appropriate meters. Emergency kit inside roomshould include forceps, clamps, emergency light, suture removal kit, and suture kit. Emergency contact information (AMP, AU, and RSO) shall be posted to include names and phone numbers. Emergency drill shall be performed at least annually. HDR: For all treatments an AU and AMP shall be present at treatment initiation, and an AMP and AU (or a trained physician responder in lieu of AU) shall be present throughout treatment. HDR: Repairs and source exchanges are only performed by appropriately licensed individuals. Manual LDR: Calibration of long half-life sources shall be directly or secondarily traceable to a national standard, with 3% mean and 5% deviation tolerance levels. Calibration shall be checked initially and should be checked each use. Manual LDR: Calibration of short half-life sources shall be directly or secondarily traceable to a national standard, and shall be checked initially to within 3% (batch mean) and 5% (max tolerated deviation). If there are a large number of seeds then the recommendations found in Table I and Table II of the AAPM Low Energy Brachytherapy Source Calibration Working Group should be followed. 8,17 1 1,7 1 1,17 1,5,7 1 1,8 8,37 66 Admin 1 67 RSO/QMP 3 68 QMP 4 Manual LDR: Procedure should be in place for providing instructions on radiation safety to nursing, the patient, and/or family members, with copies of instructions kept in the patient chart. Manual LDR: Brachytherapy sources are tracked each time they are removed from storage, implanted, and returned to storage (as applicable). Accountability includes a log of the number of sources removed/returned/implanted, activity, date, time, name of person accountable for the sources, and location of use. Permanent prostate seed implants: A QMP should be present during the procedure, perform intraoperative/interactive planning or assess the impacts of deviations from the pre-plan, and account for all seeds and needles. The post implant survey shall include a measure of the exposure rate at 1 m from the patient, and should include a surface measurement. Detailed post implant dosimetry shall be performed at an appropriate time taking into account edema, and used to evaluate doses to the target, rectal wall, and urethra. 8 Records maintained for life of license shall include RSO authority and duties, RSO signed agreement to assume responsibilities, procedures for written directives, calibrations of dosimetry systems used with remote afterloaders, Records maintained for five years shall include approval actions by management, and radiation protection program changes. Records maintained for three years shall include written directives, survey instrument calibrations, leak tests, source inventories, surveys, decay-in-storage, safety training/instructions, installation and repair of remote afterloaders, remote afterloader calibrations, routine QA of remote afterloaders (if QA not listed under another record retention requirement) Calibration records of manual brachytherapy sources shall be maintained for three years after the last use of the source. Activity records of strontium-90 sources shall be maintained for the life of the source. 1 1 38,39 Records Retention: 69 Admin 3 70 Admin 3 71 Admin 3 72 Admin 3 73 Admin 3 74 Admin 3 HDR: Safety procedures and surveys of afterloader surface radiation levels shall be maintained for the life of the unit. 1 Microspheres: 75 AU 1 19 76 AU/IR 2 77 QMP 3 IRB approval should be obtained for any treatment outside of the vendor recommended indication(s). Pre-treatment imaging and angiographic procedures shall be used for treatment decision process, assessment of arteriovenous shunting, and patient dosimetry. Unless unit dosages are administered, licensee shall possess a dose calibrator. Written 1 1 1 1 19,31 1,19,40-42 78 AU/Admin 3 79 QMP 3 80 QMP 2 81 AU/IR 3 82 AU/QMP 3 83 AU/IR 1 procedure for use and required QA checks of dose calibrators shall be developed. The QA program shall include: 1) Daily validations including an inspection, internal electronic systems check (if equipped), validation of the voltage, a check of the internal clock, zero adjustment, background check, and calibration verification (using a check source); 2) Quarterly linearity check; 3) Accuracy tests using standard sources of at least two radionuclides covering energies and activities of interest performed annually, following repair, or following extended periods of non-utilization; 3) A biennial comparison to a calibrated microsphere dose vial provided by a vendor. A method for reference activity measurements using the dose calibrator shall be established and followed in the clinic. Training specific to the delivery system, including safety procedures and three supervised cases, shall be completed and documented, for each authorized user physician. Dose vials, vial shields, and if applicable, syringe and syringe shields, shall be labeled with radionuclide and form. 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