Supplemental Table

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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.
Procedure checklist should be developed and used to ensure compliance with each step of
the treatment process.
Treatment shall be administered by the AU, or an Interventional Radiologist under the
supervision of an AU, and within the allowable time window as specified by the
manufacturer.
Records of administered dose/activity to the treatment site and other sites shall be
documented within 24 hours after treatment completed or terminated. Record must
include name of person performing assessment, date, and if the treatment was terminated
due to stasis, the AU’s signature.
Post implant imaging (e.g., Bremsstrahlung SPECT, PET/CT) should be performed to
qualitatively assess deposition of microspheres outside desirable location.
1,19,43
19,43
19
19,43
19,43
19,31
References:
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
U.S. Nuclear Regulatory Commission, Title 10, Code of Federal Regulations - Energy, Part 35, Medical use of byproduct material, 2007.
Conference of Radiation Control Program Directors (CRCPD) Suggested State Regulations. Part X - Therapeutic Radiation Machines. 2009. Available
at: http://www.crcpd.org/SSRCRs/X_2009.pdf. Accessed March 3, 2013.
American College of Radiology. ACR-ASTRO practice parameters for radiation oncology. 2014. Available at:
http://www.acr.org/~/media/ACR/Documents/PGTS/guidelines/Radiation_Oncology.pdf. Accessed September 17, 2015.
The American Board of Radiology. ABR Maintenance of Certification. http://www.theabr.org/moc-gen-landing. Accessed July 28, 2015.
Thomadsen BR, Erickson, B. A., Eifel, P. J. et al., A review of safety, quality management, and practice guidelines for high-dose-rate brachytherapy:
executive summary, Practical radiation oncology, 2014;4(2):65-70.
American College of Radiology. ACR-AAPM Technical Standard for the Performance of Low-Dose-Rate Brachytherapy. 2015. Available at:
http://www.acr.org/Quality-Safety/Standards-Guidelines/Practice-Guidelines-by-Modality/Radiation-Oncology. Accessed August 4, 2015.
American College of Radiology. ACR-AAPM Technical standard for the performance of High-Dose-Rate brachytherapy physics. 2015. Available at:
http://www.acr.org/Quality-Safety/Standards-Guidelines/Practice-Guidelines-by-Modality/Radiation-Oncology. Accessed August 4, 2015.
Nath R, L.L. Anderson, J.A. Meli et al., Code of practice for brachytherapy physics: Report of the AAPM Radiation Therapy Committee Task Group
No. 56, Medical physics, 1997;24(10):1557 - 1598.
Kutcher GJ, L. Coia, M. Gillin et al., Comprehensive QA for radiation oncology: Report of AAPM Radiation Therapy Committee Task Group 40,
Medical physics, 1994;21(4):581 - 618.
Beaulieu L, Tedgren, A. C., Carrier, J. F. et al., Report of the Task Group 186 on model-based dose calculation methods in brachytherapy beyond the
TG-43 formalism: Current status and recommendations for clinical implementation, Medical physics, 2012;39(10):6208-6236.
Ritter T, Balter, J. M., Lee, C. et al., Audit tool for external beam radiation therapy departments, Practical radiation oncology, 2012;2(4):e39-44.
U.S. Nuclear Regulatory Commission. Consolidated Guidance about Materials Licenses - Program-specific guidance about medical use licenses,
NUREG-1556, Vol. 9, Rev.2. 2008. Available at: http://pbadupws.nrc.gov/docs/ML0734/ML073400289.pdf. Accessed September 30, 2013.
U.S. Nuclear Regulatory Commission, Title 10, Code of Federal Regulations - Energy, Part 20,, Standards for protection against radiation, 2007
National Council on Radiation Protection and measurement (NCRP). Report No. 151 - Structural Shielding Design and Evaluation for Megavoltage Xand Gamma-Ray Radiotherapy Facilities. 2005.
Rivard MJ, Coursey, B. M., DeWerd, L. A. et al., Update of AAPM Task Group No. 43 Report: A revised AAPM protocol for brachytherapy dose
calculations, Medical physics, 2004;31(3):633-674.
Conference of Radiation Control Program Directors (CRCPD) Suggested State Regulations. Part G - Use of Radionuclides in the Healing Arts. 2003.
Available at: http://www.crcpd.org/SSRCRs/gpart.PDF. Accessed March 3, 2013.
Kubo HD, Glasgow, G. P., Pethel, T. D. et al., High dose-rate brachytherapy treatment delivery: Report of the AAPM Radiation Therapy Committee
Task Group No. 59, Medical physics, 1998;25(4):375-403.
National Council on Radiation Protection and measurement (NCRP). Report No. 155 - Management of Radionuclide Therapy Patients. 2006.
Dezarn WA, J.T. Cessna, L.A. DeWerd et al., Recommendations of the American Association of Physicists in Medicine on dosimetry, imaging, and
quality assurance procedures for Y-90 microsphere brachytherapy in the treatment of hepatic malignancies, Medical physics, 2011;38(8):4824 - 4845.
National Council on Radiation Protection and measurement (NCRP), Report No. 161 - Management of Persons Contaminated With Radionuclides,
2008.
International Commission on Radiological Protection (ICRP), Release of Patients after Therapy with Unsealed Radionuclides. ICRP Publication 94,
Ann. ICRP, 2004;34(2).
22.
23.
24.
25.
26.
27.
28.
29.
30.
31.
32.
33.
34.
35.
36.
37.
38.
39.
40.
Halvorsen PH, Das, I. J., Fraser, M. et al., AAPM Task Group 103 report on peer review in clinical radiation oncology physics, J Appl Clin Med Phys,
2005;6(4):50-64.
U.S. Nuclear Regulatory Commission, Title 10, Code of Federal Regulations - Energy, Part 19, Notices, instructions and reports to workers: Inspection
and investigations, 2007.
U.S. Nuclear Regulatory Commission. NRC Inspection Manual, Manual Chapter 2800: Materials Inspection Program. 2010. Available at:
http://pbadupws.nrc.gov/docs/ML1028/ML102800160.pdf. Accessed May 23, 2012.
U.S. Nuclear Regulatory Commission, Title 49, Code of Federal Regulations, Part 172, Hazardous materials table, special provisions, hazardous
materials communications, emergency response information, training requirements, and security plans, 2001.
U.S. Nuclear Regulatory Commission, Title 49, Code of Federal Regulations, Part 173, Shippers, 2003.
Mutic S, Palta, J. R., Butker, E. K. et al., Quality assurance for computed-tomography simulators and the computedtomography-simulation process:
Report of the AAPM radiation therapy committee task group no. 66, Medical physics, 2003;30(10):2762-2792.
Pfeiffer D, Sutlief, S., Feng, W. Z. et al., AAPM Task Group 128: Quality assurance tests for prostate brachytherapy ultrasound systems, Medical
physics, 2008;35(12):5471-5489.
American College of Radiology. ACR practice parameter for performing and interpreting magnetic resonance imaging (MRI). 2014. Available at:
http://www.acr.org/Quality-Safety/Standards-Guidelines/Practice-Guidelines-by-Modality. Accessed June 3, 2015.
Viswanathan ANaT, B., American Brachytherapy Society consensus guidelines for locally advanced carcinoma of the cervix. Part I: General principles,
Brachytherapy, 2012;11(1):33-46.
American College of Radiology. ACR–SIR practice parameter for radioembolization with microsphere brachytherapy device (RMBD) for treatment of
liver malignancies. 2014. Available at: http://www.acr.org/Quality-Safety/Standards-Guidelines/Practice-Guidelines-by-Modality/Interventional.
Accessed June 3, 2015.
American College of Radiology. ACR–ASTRO practice parameter for the performance of Low-Dose-Rate brachytherapy. 2014. Available at:
http://www.acr.org/Quality-Safety/Standards-Guidelines/Practice-Guidelines-by-Modality/Radiation-Oncology. Accessed June 3, 2015.
American College of Radiology. ACR–ASTRO practice parameter for the performance of therapy with unsealed radiopharmaceutical sources. 2014.
Available at: http://www.acr.org/Quality-Safety/Standards-Guidelines/Practice-Guidelines-by-Modality/Nuclear-Medicine. Accessed June 3, 2015.
The Joint Commission. 2015 National Patient Safety Goals. 2015; http://www.jointcommission.org/standards_information/npsgs.aspx. Accessed
January 30, 2015.
U.S. Nuclear Regulatory Commission. NRC information notice 2013-16: importance of verification of treatment parameters for high dose-rate remote
afterloader administrations. 2013. Available at: http://www.illinois.gov/iema/NRS/RadSafety/documents/NRCInformationNoticeML13058A306.pdf.
Accessed September 30, 2013.
Fraass BA, K. Doppke, G. Kutcher et al.,, American Association of Physicists in Medicine Radiation Therapy Committee Task Group 53: Quality
assurance for clinical radiotherapy treatment planning, Medical physics, 1998;25(10):1773 - 1829.
Butler WM, Bice, W. S., DeWerd, L. A. et al. , Third-party brachytherapy source calibrations and physicist responsibilities: Report of the AAPM Low
Energy Brachytherapy Source Calibration Working Group, Medical physics, 2008;35(9):3860-3865.
Yu Y, L.L. Anderson, Z. Li et al., Permanent prostate seed implant brachytherapy: Report of the American Association of Physicists in Medicine Task
Group No. 64, Medical physics, 1999;26(10):2054 - 2076.
Nath R, W.S. Bice, W.M. Butler et al. AAPM Recommendations on dose prescription and reporting methods for permanent interstitial brachytherapy
for prostate cancer: Report of Task Group 137, Medical physics, 2009; 36(11):5310 - 5322.
Carey J, Byrne, P., DeWerd, L. A. et al. AAPM Task Group 181:The selection, use, calibration, and quality assurance of radionuclide calibrators used
in nuclear medicine. College Park, MD2012. Available at: http://www.aapm.org/pubs/reports/RPT_181.pdf. Accessed August 4, 2015.
41.
42.
43.
International Atomic Energy Agency (IAEA). Quality Assurance for Radioactivity Measurement in Nuclear Medicine (Technical Reports Series No.
454). 2006. Available at: http://www-pub.iaea.org/MTCD/publications/PDF/trs454_web.pdf. Accessed September 22, 2015.
The Institute of Electrical and Electronics Engineers I. American National Standard: Calibration and Usage of "Dose Calibrator" Ionization Chambers
for the Assay of Radionuclides. ANSI N42.13-1986. 1985. Available at: http://ieeexplore.ieee.org/stamp/stamp.jsp?arnumber=29092&tag=1. Accessed
September 22, 2015.
U.S. Nuclear Regulatory Commission. NRC Licensing Guidance – TheraSphere® and SIR-Spheres® Yttrium-90 Microspheres 2012. Available at:
http://pbadupws.nrc.gov/docs/ML1217/ML12179A353.pdf. Accessed September 30, 2013.
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