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KEMENTERIAN KESIHATAN MALAYSIA
MANUAL PELAKSANAAN
PROGRAM JAMINAN MUTU (QAP)
DALAM PERKHIDMATAN
RADIOTERAPI
Disediakan oleh:
Kumpulan Kerja Pelaksanaan Program Jaminan Mutu Dalam Perkhidmatan
Radioterapi Di Bawah Akta Perlesenan Tenaga Atom 1984 (Akta 304)
Kementerian Kesihatan Malaysia
Julai 2012
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1. PENGENALAN
Program Jaminan Mutu (Quality Assurance Programme-QAP) di Kementerian
Kesihatan Malaysia telah dilancarkan pada tahun 1985. Objektif pelaksanaan QAP
adalah untuk memastikan pelanggan mendapat faedah daripada perkhidmatan yang
disediakan pada tahap yang optima dengan sumber yang sedia ada. Indikator-indikator
diwujudkan untuk memantau kualiti pelbagai perkhidmatan dari aspek penjagaan,
pengurusan pelanggan, resources utilization dan kepuasan pelanggan.
Dalam konteks pelaksanaan QAP yang menggunakan sinaran mengion bagi tujuan
terapi, kualiti rawatan ke atas pesakit perlu diutamakan. Manual ini dijadikan sebagai
satu rujukan untuk membantu pelaksanaan QAP dalam perkhidmatan radioterapi.
Objektif program ini adalah untuk memastikan kualiti perkhidmatan yang diberikan oleh
institusi-institusi perubatan kerajaan dan swasta mampu meningkatkan tahap
keselamatan pesakit, pekerja dan orang awam daripada risiko yang mungkin timbul
akibat penggunaan radas penyinaran dan bahan radioaktif. Fokus utama manual ini
disediakan adalah untuk menjadi panduan kepada program peningkatan kualiti secara
berterusan.
Keperluan pelaksanaan QAP ini adalah memenuhi kehendak Peraturan 53(1) dalam
Peraturan-Peraturan Perlesenan Tenaga Atom (Perlindungan Sinaran Keselamatan
Asas) 2010 yang mengkehendaki pemegang lesen mewujudkan suatu program
jaminan mutu yang komprehensif bagi dedahan perubatan dengan penglibatan pakar
berkelayakan yang sesuai dalam bidang yang berkaitan sebagaimana yang dinyatakan
oleh pihak berkuasa yang berkenaan.
Selain itu, Peraturan 41(e) dalam Peraturan berkenaan juga mengkehendaki tiap-tiap
pemegang lesen atau majikan memastikan bahawa bagi penggunaan sinaran secara
terapeutik termasuk teleterapi atau brakiterapi, penentukuran, dosimetri dan program
jaminan mutu yang dinyatakan oleh pihak berkuasa yang berkenaan dijalankan oleh
atau di bawah penyeliaan seorang pakar yang berkelayakan dalam fizik perubatan.
Mesyuarat Jawatankuasa Penasihat Radiologi (RAC) ke-37 yang diadakan pada 15hb.
Julai 2010 telah memutuskan supaya pelaksanaan QAP dalam perkhidmatan
radioterapi di sektor kerajaan dan swasta diperkukuhkan. Melalui pelaksanaan QAP
tersebut, pusat-pusat radioterapi akan dapat menerap dan mengamalkan budaya kualiti
dan selamat dalam penggunaan sinaran mengion untuk tujuan perubatan kepada
pesakit, pekerja dan orang awam.
Untuk memastikan QAP dilaksanakan dengan berkesan, jabatan berkaitan perlu
mewujudkan Jawatankuasa QAP yang terdiri daripada pakar onkologi, ahli fizik
perubatan, juru x-ray terapi dan lain-lain profesion yang terlibat.
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2. OBJEKTIF
Objektif pelaksanaan QAP dalam perkhidmatan radioterapi adalah :
2.1 Meningkatkan kualiti perkhidmatan radioterapi
2.2 Memastikan ketepatan dan kejituan dalam rawatan pesakit
2.3 Memastikan penggunaan sumber yang sedia ada secara efektif dan selamat
2.4 Memenuhi dan mematuhi keperluan peraturan-peraturan di bawah Akta
Perlesenan Tenaga Atom 1984 (Akta 304)
3. PELAKSANAAN QAP SEBAGAI KEPERLUAN REGULATORI
QAP hendaklah dilaksanakan di setiap pusat radioterapi dengan merangkumi elemen-
elemen seperti di bawah:-
3.1 Indikator - “The rate of discrepancies of treatment verification images”
Indikator “The rate of discrepancies of treatment verification images” hendaklah
dipantau dan dianalisa di setiap pusat radioterapi. Laporan analisa tersebut
termasuk tindakan pembaikan yang telah diambil perlu dikaji setiap tahun.
Perbandingan imej yang diambil semasa rawatan dan proses simulasi adalah
bertujuan untuk mengesahkan ketepatan rawatan yang diberi, terutamanya
melibatkan organ kritikal yang berdekatan dengan kawasan rawatan. Ia hendaklah
dilakukan terhadap sekurang-kurangnya 50% pesakit yang menjalani rawatan
radikal dalam masa 3 hari pertama di permulaan rawatan.
Maklumat lanjut mengenai kaedah pelaksanaan indikator di Lampiran A.
3.2 Kawalan kualiti (QC) bagi radas penyinaran radioterapi dan kemudahan
berkaitan termasuk prosidur khas
Semua radas penyinaran radioterapi dan kemudahan berkaitan termasuk prosidur
khas hendaklah diselenggara dan dikalibrasi secara berkala. Prosidur khas adalah
seperti Stereotactic Radiosurgery/Radiotherapy (SRS/SRT), Intensity Modulated
Radiation Therapy (IMRT) dan Interstitial Brachytherapy.
Kawalan mutu (QC) bagi setiap radas penyinaran radioterapi hendaklah memenuhi
standard prestasi dan keselamatan yang ditetapkan seperti di Lampiran B.
Laporan berkenaan hendaklah disahkan oleh Juruperunding Fizik Perubatan atau
Ahli Fizik Perubatan Hospital yang diiktiraf oleh KKM.
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3.3 Pendidikan Profesional Berterusan (CPE)
Semua personel hendaklah menghadiri program CPE yang diiktiraf oleh pihak
berkuasa di bawah Akta 304 untuk meningkatkan pengetahuan dan kompetensi.
Tempoh latihan hendaklah sekurang-kurangnya 12 jam terkumpul setahun dengan
sekurang-kurangnya merangkumi salah satu daripada topik-topik seperti berikut:-
Clinical Aspects of Radiobiology
Radiation Safety and Protection
External Beam Radiation Dosimetry
External Beam Radiation Therapy
External Beam Treatment Planning
Brachytherapy
Quality Assurance Programme in Radiotherapy
Legislation and Regulatory Requirement
Bukti seperti salinan sijil penyertaan atau senarai kehadiran hendaklah disahkan
oleh Ketua Jabatan atau agensi penganjur bagi setiap personel terlibat.
4. PENGURUSAN REKOD
Kesemua elemen QAP yang dinyatakan seperti di Perkara 3 hendaklah dikemukakan
kepada KKM setiap tahun sebagai keperluan regulatori, iaitu Annual Analysis Report for
the Rate of Discrepancies of Treatment Verification Images (Form B), sijil/laporan QC
dan salinan sijil/bukti kehadiran CPE.
Rekod-rekod berkenaan dan rekod-rekod yang berkaitan hendaklah diurus dan
disimpan dalam tempoh yang ditetapkan oleh KKM.
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DEFINISI
Central axis The imaginary axis or line which passes through both the x-ray source and the isocentre of the machine.
Gating Gating or respiratory gating is a treatment delivery technique
which allows the treatment of tumours at certain defined points in the respiratory cycle.
Image acquisition The process of acquiring image data. In the context of
geometric verification, it may be a 2D (planar) or a 3D (volume) set of data, and may be obtained with either ionizing or non-ionising radiation.
Image registration Methods of aligning two 3D image sets; for example, CT, MRI, PET etc. Image sets may be overlaid or structures may be mapped between the sets.
Intact
Describes something that is complete and that has not been damaged in any way.
Integrity The absence of unintended changes or errors. Isocentre A single point within the treatment room (in space) towards
which the radiation beam always points. The central beam axis passes through this point and, on a LINAC, the three principle rotational movements of gantry, collimator and floor are all around axes which intersect at this point. For a tomotherapy machine, it is a point of intersection between the centre of the scan plane and the axis of rotation of the scan cycle.
Set-up errors (field placement errors)
Any geometric displacement in patient set-up (localisation) with respect to the desired reference defined by the treatment plan, which is present at the time of patient set-up during delivery.
Systematic errors
Geometric displacements in patient set-up (localisation) with respect to the desired reference defined by the treatment plan, which are similar in both magnitude and direction for each treatment fraction. These are primarily due to systematic differences in equipment or protocol throughout the radiotherapy process (that is, from pre-treatment imaging to treatment planning to pre-treatment verification etc.).
Tolerances
The permitted observed variation in a parameter or measurement from its desired value.
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SINGKATAN
AAPM American Association of Physicists in Medicine
AEC Automatic Exposure Control
AQA Automatic Quality Assurance
CT Computed Tomography
CTDI Computed Tomography Dose Index
deg Degree
EPID Electronic Portal Imaging Device
FWHM Full width at half maximum
HU Hounsfield Unit
HVL Half Value Layer
IEC International Electro-technical Commission
kV kilo voltage
mMLC mini Multileaf Collimator
MU Monitor Unit
MV Megavoltage
MVCT Megavoltage Computed Tomography
PDD Percentage Depth Dose
PDD10 Percentage depth dose at water depth of 10 g/cm2
QA Quality Assurance
QC Quality Control
RMS Root Mean Square
SAD Source to axis distance
SDD Source to Diaphragm Distance
TAR Tissue Air Ratio
TMR Tissue Maximum Ratio
TMR20
10 Tissue Maximum Ratio in water at depths of 20 g/cm2 and 10 g/cm2
WF Wedge Factor
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RUJUKAN
i. Akta Perlesenan Tenaga Atom 1984 (Akta 304).
ii. Peraturan-Peraturan Perlesenan Tenaga Atom (Perlindungan Sinaran Keselamatan Asas) 2010.
iii. Peraturan-Peraturan Perlindungan Sinaran (Perlesenan) 1986.
iv. Ministry of Health Malaysia. Quality Assurance-A Problem Solving Approach. Kuala Lumpur: MOH.
v. International Atomic Energy Agency. 2005. Radiation oncology physics: A handbook for teachers and students. Austria, Vienna: IAEA.
vi. Kutcher GJ, Cola L, Gillin M, Hanson WF, Leibel S, Morton RJ and et al. Comprehensive QA for Radiation Oncology: Report of AAPM Radiation Therapy Committee Task Group 40. Medical Physics. 1994: 21(4).
vii. Mutic S, Palta JR, Butker EK, Das IJ, Huq MS and et al. Quality assurance for computed-tomography simulators and the computed tomography-simulation process: Report of the AAPM Radiation Therapy Committee Task Group No. 66. Medical Physics. 2003: 30(10).
viii. Klein EE, Hanley J, Bayouth J, Yin FF and et al. Quality assurance of medical accelerators: Task Group 142 report: Quality assurance of medical accelerators. Medical Physics. 2009: 36(9).
ix. Dieterich S, Cavedon C, Chuang CF, Cohen AB and et al. Quality assurance for robotic radiosurgery: Report of AAPM TG 135. Medical Physics. 2011: 38(6).
x. Langen KM, Papanikolaou N, Balog J, Crilly R, Followill D, Goddu AM and et al. QA for Helical Tomotherapy: Report of the AAPM Task Group 148. Medical Physics. 2010: 37(9).
xi. Khan FM. The Physics of Radiation Therapy. USA: Williams and Wilkins. 2003.
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STRUCTURE OF A PERFORMANCE INDICATOR FOR RADIOTHERAPY
PROGRAMME : Radiotherapy Services
AREA OF CONCERN : Performance Quality and Radiation Safety of Radiotherapy
Services
INDICATOR : The Rate Of Discrepancies of Treatment Verification Images
DEFINITION OF TERM Treatment verification images are defined as the images taken on the treatment machine to confirm the accuracy of the intended treatment fields. It must be done within the first 3 days of starting treatment. RATIONALE The process of delivery of radiation is laborious, particularly for radical treatment. This is especially true for cases where important vital structures and organs are situated in the vicinity of the radiation portals. Simulating the treatment field portals is a process done to ensure that the radiation fields are where it is intended to be. However due to many technical factors such as setup difficulties, machine accuracy, transfer of data etc, this may not be reproducible at the time of treatment. Verification images done during the actual treatment can be compared to the simulation images and any discrepancies can be corrected before treatment is allowed to progress. This will help to maximize accuracy of treatment and will address systematic errors.
TYPE OF INDICATOR : This is a rate-based indicator. It is a measure of clinical, physics and maintenance services.
NUMERATOR : Total number of rejected verification images
DENOMINATOR : Total number of verification images taken
CALCULATION OF RATE : (Numerator/Denominator) x 100 %
ACCEPTABLE DEVIATION
: Head and neck – less than or equal to 3mm Extremities/abdomen/pelvis/thorax – less than or equal to 5mm
STANDARD : Discrepancy rate should be less than 25%
LAMPIRAN A
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METHODOLOGY
1. Data Collection
i. Select patients for radical radiotherapy;
ii. Acquire first uncorrected verification image within the first 3 days of radiotherapy;
iii. Record in Form A.
2. Data Analysis
This involves transferring data from Form A to Form B. The tabulated data can then be
analyzed to determine the types of errors. Data analysis can be carried out monthly, 3-6
monthly or annually depending on the respective centre.
3. Results
The final presentation by using Form B shall be sent to the appropriate authority annually.
4. Investigation protocol for abnormal discrepancies from intended treatment field
i. Identify cause of discrepancies - from the table (Form A). The reason for the
discrepancies will most likely be obvious from the analysis and presentation table.
ii. Remedial action is carried out based on the cause ascertained.
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PORTAL VERIFICATION FORM
No. Patient IC No.
Date Method of image
acquisition
Treatment site
Set up errors (mm)
Accepted (/)/ Rejected (X)
*Type of verification
errors Remarks Start
treatment Acquisition
1
2
3
4
5
6
7
8
9
10
* Type of verification errors: A: Isocentre Shift B: Incorrect Field Orientation (X,Y) C: Incorrect Field Size D: Shielding E: Others (Please specify)
Form A
Prepared by : ...............................
(Signature & Cop)
Date : .............................
MONTH: ...................
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ANNUAL ANALYSIS REPORT FOR
THE RATE OF DISCREPANCIES OF TREATMENT VERIFICATION IMAGES
Name of Hospital : ..................................................................
Year : ..................................................................
Month Total number of
verification images taken
Total number of rejected verification
images
*Rate of discrepancies (%)
Jan
Feb
Mac
Apr
May
Jun
Jul
Aug
Sept
Oct
Nov
Dec
Total
* 100%taken being images onverificati of number Total
images rejected of number Total (%) iesdiscrepanc of rate The
Total number of patients per year undergoing radical treatment : ...........................................
Total number of the above patients per year having verification done : ...........................................
Percentage (%) of the above patients having verification done : ..........................................
SHORTFALLS IN QUALITY Causes : …………………………………………………………………………………………….
…………………………………………………………………………………………….
…………………………………………………………………………………………….
Corrective actions taken : …………………………………………………………………………………………….
…………………………………………………………………………………………….
…………………………………………………………………………………………….
Verified by : ……………………………………………………………………………………………. (Signature & Chop)
Form B
Form B
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STANDARD DAN KRITERIA PRESTASI DAN KESELAMATAN BAGI RADAS
PENYINARAN RADIOTERAPI DAN KEMUDAHAN BERKAITAN
Jadual 1 : Simulator
Jadual 2 : CT Simulator
Jadual 3 : Irradiating Apparatus below 1 MV
Jadual 4 : Linear Accelerator (LINAC)
Jadual 4.a : Additional QC Parameters for LINAC-Based Stereotactic
Radiosurgery/Radiotherapy (SRS/SRT)
Jadual 4.b : Additional QC Parameters for LINAC-Based Intensity
Modulated Radiation Therapy (IMRT)
Jadual 4.b.i : Additional QC Parameters for Multi-leaf Collimation (with differentiation of IMRT vs. non-IMRT machines)
Jadual 4.b.ii
: Additional QC Parameters for Dynamic/Universal/Virtual
Wedges
Jadual 5 : Helical Tomotherapy
Jadual 6 : Cyberknife
Jadual 7
Jadual 7.a
Jadual 7.b
:
:
:
Brachytherapy
Remote Afterloading Brachytherapy Unit
Special Procedures for Permanent Interstitial Brachytherapy
Jadual 8 : Treatment Planning System for Teletherapy
Jadual 9 : Imaging Systems (Portal Imaging and Image Guided Radiation
Therapy)
Jadual 10 : Intraoperative Radiation Therapy (Low kV Photon)
LAMPIRAN B
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Jadual 1: Simulator
No. Parameters Tolerance Frequency
1. Mechanical Checks
i. Localising lasers 2 mm Daily
ii. Optical Distance Indicator (ODI) 2 mm
iii. Field size indicator 2 mm
Radiation Safety Checks
i. Radiation on/off warning light Functional Daily
ii. Emergency button Functional Quarterly
2. Mechanical Checks
i. Gantry/collimator angle indicators 1º Monthly
ii. Cross-hair centring 2 mm diameter
iii. Focal spot-axis indicator 2 mm
iv. Emergency/collision avoidance Functional
v. Light/radiation field coincidence 2 mm or 1%
vi. Collimator rotation isocentre 2 mm diameter
vii. Gantry rotation isocentre 2 mm diameter
viii. Couch rotation isocentre 2 mm diameter
ix. Coincidence of collimator, gantry, couch axes and isocentre
2 mm diameter
x. Table top sag 2 mm
xi. Vertical travel of couch 2 mm
3. Radiographic and Fluoroscopic Checks
i. Exposure reproducibility 10% Annually or after
maintenance services*
ii. Exposure linearity 10%
iii. kVp accuracy 5% or 5kV whichever is greater
iv. High and low contrast resolution Baseline
v. Image Receptor Input Dose Rate Manufacturer’s Specification
vi. Entrance Surface Dose Rate Limit
a. Equipment with AEC
b. Equipment without AEC
<100mGy per minute
<50mGy per minute
vii. Leakage radiation Shall not exceed 1mGy in an hour and should not exceed
0.1mGy in an hour at 1m from the source (for every
rating specified by manufacturer)
4. Scattered radiation <0.1mGy (10mR) in a week
Annually
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* Notes:
i. The tolerances for simulator are stricter than for linear accelerators because errors at treatment planning stages on the simulator carry through to each treatment on the linear accelerator.
ii. The maintenance services refer to those services that involved the changing of major parts of the machine, which might affect the dose given to the patient and the quality of the images produced.
iii. The Quality Assurance (QA) program should be based on a thorough investigation for baseline standards at the time of the acceptance and commissioning of the equipment for clinical use. The procedures for acceptance tests should be followed to verify the manufacturer’s specifications and to establish baseline performance values for new or refurbished equipment, or for equipment following major repair. Once a baseline standard has been established, a protocol for periodic QA tests should be developed for the purpose of monitoring the reference performance values.
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Jadual 2: CT Simulator
No. Parameters Tolerance Frequency
1. Mechanical Checks
Localising lasers
2mm
Daily
Radiation Safety Checks
i. Radiation on/off warning light Functional Daily
ii. Emergency button Functional Quarterly
2. X-Ray Generator
i. Accuracy of kVp ± 5% or 5kV (whichever is greater) Annually
ii. Accuracy of exposure time ± 10%
iii. Exposure linearity (mR/mAs) Coefficient of linearity ≤ 0.1
iv. Radiation output reproducibility Coefficient of variation ≤ 0.1
3. Radiation Dosimetry
i. Patient dosimetry (CTDI) Manufacturer specifications Annually
ii. Scout localisation image ±20% of nominal value
4. Scan Localisation
i. Axial scan localisation light accuracy
±2 mm
Annually
ii. Isocentre alignment, sagittal and coronal localisation light accuracy
±5 mm
iii. Gantry tilt accuracy ±3º
iv. Table index ±0.5 mm
v. Table position ±2.0 mm
vi. Image scan width (sensitivity profile)
a. Single slice ±0.5 mm (<5 mm prescribed scan width)
b. Multi slice ±1 mm (≥5 mm prescribed scan width)
5. Image Display
i. Visual display Luminance and contrast not significantly different from hard copy;
Daily
Geometric distortion not exceed ±1 mm.
Monthly
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No. Parameters Tolerance Frequency
ii. Hard copy display 5% and 95% patches must be visible, no noticeable artefacts;
Geometric distortion not exceed ±1 mm;
Optical density values must be within specified range.
Annually
6. Image Quality
i. CT number uniformity
±5 HU Monthly
ii. Image artefacts (transaxial and scan localisation images
No significant artefacts
iii. Noise Standard deviation of CT numbers varies as reciprocal square root of
mAs
Semi-Annually
iv. Low contrast resolution 5 mm Annually
v. High contrast resolution 1 mm holes (5lp/cm) Annually
7. Quantitative Accuracy
i. CT number constancy Value and standard deviation for water remains relatively constant
Daily
ii. CT number calibration Water : 0 ± 5HU Monthly
iii. Accuracy of distance measurements (transaxial and scan localisation images)
±1 mm
Annually
iv. CT number dependence on scan thickness
± 3HU
v. CT number dependence on phantom size
± 20HU
vi. CT number dependence on phantom position
± 5HU
vii. CT number dependence on reconstruction algorithm
± 3HU
8. Scattered and Leakage Radiation
i. Scattered radiation <0.1mGy (10mR) per week
Annually
ii. Leakage radiation Shall not exceed 1mGy in an hour and should not exceed 0.1mGy in an hour at 1m from the source (for every rating specified by manufacturer)
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No. Parameters Tolerance Frequency
9. External Localisation Laser
Orientation of gantry lasers with respect to the imaging plane
±2 mm over the length of laser projection
Monthly
Spacing of lateral wall lasers with respect to lateral gantry lasers and scan plane
±2 mm
Orientation of wall lasers with respect to the imaging plane
±2 mm over the length of laser projection
Orientation of the ceiling laser with respect to the imaging plane
±2 mm over the length of laser projection
Orientation of the CT-scanner tabletop with respect to the imaging plane
±2 mm over the length and width of the tabletop
Table vertical and longitudinal motion ±1 mm over the range of table
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Jadual 3: Irradiating Apparatus below 1 MV
No. Parameters Tolerance Frequency
1. Mechanical Checks
i. Mechanical integrity of the unit Functional Quarterly
ii. Firmness of the locking devices Functional
2. Radiation Safety Checks
i. Door interlock Functional Daily
ii. Radiation on/off warning light Functional Daily
iii. Emergency button Functional Quarterly
iv. Locking devices Functional Quarterly
3. Dosimetry
i. Absolute dose
Standard recognised by the appropriate authority
Semi-Annually
ii. HVL test Semi-Annually
iii. Beam homogeneity film test Semi-Annually
iv. Cut out lead transmission factors Every new batch of lead
v. Light/radiation field coincidence ±2 mm or 2% Semi-Annually
4. i. Tube head leakage
a) Contact therapy
b) < 500 kVp
c) 500 kVp - 999 kVp
1 mGy per hour at 5 cm from the tube housing
10 mGy per hour at 1 m from the source
0.1 percent of useful beam or 10 mGy per
hour, whichever is greater at 1 m from the source
Tube head change or
service
ii. Applicator geometrical accuracy and beam axis indication on rotation
< 2 mm Quarterly
iii. Dose monitor reproducibility
iv. Dose monitor linearity
v. Output consistency
< 0.5%
2%
3%
Quarterly
Quarterly
Quarterly
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Jadual 4: Linear Accelerator
No. Parameters Tolerance Frequency
1. Mechanical Checks
i. Localising lasers 2 mm Daily
ii. Optical Distance Indicator (ODI) 2 mm
iii. Field light Functional
Safety Checks
i. Door Interlock Functional
ii. Audiovisual monitor Functional
2. Dosimetry
i. X-ray output constancy 2% Weekly
ii. Electron output constancy 2%
iii. X-ray beam flatness constancy 2% Quarterly
iv. Electron beam flatness constancy 3%
v. X-ray and electron symmetry 3%
vi. Backup monitor constancy 2%
3. Mechanical Checks
i. Light/radiation field coincidence 2 mm for field up to 20 cm or ± 1% for field over 20 cm
Monthly
ii. Gantry/collimator angle indicators 1 deg
iii. Wedge position 2 mm (or 2% change in transmission factor)
iv. Tray position 2 mm
v. Applicator position 2 mm
vi. Field size indicators 2 mm
vii. Cross-hair centring 2 mm diameter
viii. Treatment couch position indicators 2mm/1 deg
ix. Latching of wedges, blocking tray Functional
x. Jaw symmetry 2 mm
Safety Checks
i. Emergency off switches Functional
ii. Wedge, electron cone interlocks Functional
4. Dosimetry
i. X-ray/electron output calibration constancy
2%
Annually
ii. Photon central axis parameter constancy (PDD, TAR)
2%
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No. Parameters Tolerance Frequency
iii. Electron central axis dosimetry parameter constancy (PDD)
2 mm at therapeutic depth
iv. Field size dependence of x-ray output constancy
2%
v. Output factor constancy for electron applicators
2%
vi. X-ray output constancy vs. gantry angle 2%
vii. Electron output constancy vs. gantry angle
2%
viii. Wedge transmission factor constancy 2%
ix. Monitor chamber linearity 1%
x. Transmission factor constancy for all treatment accessories
2%
xi. Arc mode Manufacturers’ specification
Safety Interlocks
Follow manufacturers test procedures Functional
Mechanical Checks
i. Collimator rotation isocentre 2 mm diameter
ii. Gantry rotation isocentre 2 mm diameter
iii. Couch rotation isocentre 2 mm diameter
iv. Coincidence of collimator, gantry, couch axes with isocentre
2 mm diameter
v. Coincidence of radiation and mechanical isocentre
2 mm diameter
vi. Table top sag 2 mm
vii. Vertical travel of table 2 mm
Scattered radiation
< 0.1mGy (10mR) per week
Note:
Absolute dose calibration needs to be performed after each maintenance service that involved the change of major parts which affect the dosimetry.
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Jadual 4.a: Additional QC Parameters for LINAC-Based Stereotactic Radiosurgery/Radiotherapy (SRS/SRT)
No. Parameters Tolerance Frequency
1. Laser localisation check
1 mm Daily
2. Winston Lutz test 1.5 mm Weekly (SRT)/
Before treatment (SRS)
3. Patient-specific plan verification
i. Plan parameters check
ii. Collision check in each field SRS/SRT field
iii. MLC/mMLC/Cone accuracy with light field in each SRS/SRT field
Pass/fail
Before first treatment for each patient
Before each fraction
4. Patient-specific treatment verification (Image Guided)
i. For SRS treatment
ii. For SRT treatment
1 mm
2 mm
Before treatment
5. Safety Check
Stereotactic interlocks Functional Daily
6. Dosimetry
Typical dose rate output constancy 2% Monthly
Mechanical
Treatment couch position indicators 1 mm/0.5°
7. Dosimetry
i. SRS arc rotation mode
(range: 0.5-10MU/deg)
Monitor units set vs. delivered:
1 MU or 2% (whichever is greater)
Gantry arc set vs. delivered:
1° or 2% (whichever is greater)
Annually
ii. X-ray monitor unit linearity
(output constancy)
±5% for 2 - 4 MU
±2% for ≥ 5 MU
Mechanical Checks
i. Coincidence of radiation and mechanical isocentre
±1 mm from baseline
ii. Stereotactic accessories, lockouts, etc.
Functional
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Jadual 4.b: Additional QC Parameters for LINAC-Based
Intensity Modulated Radiation Therapy (IMRT)
No. Parameters Tolerance Frequency
1. Individual patient plan verification ±5% (point dose), other per clinical significance
Before first treatment
2. Mechanical Check
Laser localisation
1.5 mm
Daily
3. Dosimetry
i. Typical dose rate output constancy 2% (@ IMRT dose rate) Monthly
ii. Photon beam profile constancy 1%
Mechanical Checks
i. Distance check device for lasers compared with front pointer
1 mm
ii. Accessory trays (i.e., port film graticule tray)
2 mm
iii. Cross-hair centring (walkout) 1 mm (diameter)
iv. Localising lasers ±1 mm
*Safety Check
Laser guard-interlock test Functional
*Respiratory Gating
Beam output constancy 2%
i. Phase, amplitude beam control Functional
ii. In room respiratory monitoring system Functional
iii. Gating Interlock Functional
4. Dosimetry
i. X-ray flatness change from baseline 1% Annually
ii. X-ray symmetry change from baseline ±1%
iii. X-ray output calibration ±1% (absolute)
iv. Spot check of field size dependent output factors for x ray(two or more FSs)
2% for field size <4x4 cm2, 1% for field size ≥4x4 cm2
v. X-ray beam quality (PDD10 or 20
10TMR ) ±1% from baseline
vi. X-ray monitor unit linearity (output constancy)
±5% (2–4 MU)
±2% ≥5 MU
vii. X-ray output constancy vs. dose rate ±2% from baseline
viii. X-ray output constancy vs. gantry angle ±1% from baseline
ix. Arc mode (expected MU, deg) ±1% from baseline
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No. Parameters Tolerance Frequency
Mechanical Checks
Table travel maximum range movement in all directions
±2 mm
Safety Checks
Follow manufacturer’s test procedures Functional
*Respiratory gating
Beam energy constancy 2%
Temporal accuracy of phase/amplitude gate on
100ms of expected
Calibration of surrogate for respiratory phase/amplitude
100ms of expected
Interlock testing Functional
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Jadual 4.b.i: Additional QC Parameters for Multi-leaf Collimation
(With differentiation of IMRT vs. non-IMRT machines)
No. Parameters Tolerance Frequency
1. Qualitative test (i.e., matched segments, also known as ―picket fence‖)
Visual inspection for discernable deviations from expected leaf
position
Monthly (IMRT
machines)
2. i. Setting vs. radiation field for two patterns (non-IMRT)
2 mm Monthly
ii. Travel speed (IMRT for sliding window technique)
Loss of leaf speed > 0.5cm/s
iii. Leaf position accuracy (IMRT)
1 mm for leaf positions of an IMRT field for four cardinal gantry
angles*
3. i. MLC transmission (average of leaf and interleaf transmission), all energies
±0.5% from baseline
Annually
ii. Leaf position repeatability ±1.0 mm
iii. MLC spoke shot ≤1.0 mm radius
iv. Coincidence of light field and x-ray field (all energies)
±2.0 mm
v. Segmental IMRT (step and shoot) test
<0.35 cm max. error RMS, 95% of error counts <0.35 cm
vi. Moving window IMRT (four cardinal gantry angles)
<0.35 cm max. error RMS, 95% of error counts <0.35 cm
*Note:
i. The tolerance for leaf position accuracy is 2mm for those LINAC installed before the year of 2011.
ii. Picket fence test may be used. Test depends on clinical planning-segment size.
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Jadual 4.b.ii: Additional QC Parameters for Dynamic/universal/virtual wedges
No. Parameters Tolerance Frequency
Dynamic Universal Virtual
1. Morning check-out run for one angle
N/A* Functional N/A* Daily
2. Wedge factor for all energies Central axis 45º or 60º WF (within 2%)
Central axis 45º or 60º WF (within 2%)
5% from unity, otherwise 2%
Monthly
3. Check of wedge angle for 60º, full field spot check for intermediate angle
Check of off-centre ratios @ 80% field width @ 10 cm to be within 2%
Annually
*N/A – Not applicable
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Jadual 5: Helical Tomotherapy
No. Parameters Tolerance Frequency
1. i. Output – rotational or static 3% Daily
ii. Image/laser coordinate coincidence 2 mm for non-SRS/SBRT
1 mm for SRS/SBRT
iii. Image registration/alignment 1mm
iv. Red laser initialization 1.5 mm for non-SRS/SBRT
1 mm for SRS/SBRT
Radiation Safety Checks
i. Door Interlock Functional
ii. Audiovisual monitor Functional
2. Beam parameters
Output—Static 2% Monthly
Output—Rotational 2%
Monitor chamber constancy 2%
Rotation output variation 2%
Beam quality 1% PDD10 or 20
10TMR
Transverse profile 1% average difference in field core
Longitudinal profiles (each slice width) 1% of slice width at FWHM
Alignment and Miscellaneous
Interrupted procedure
(agreement with uninterrupted procedure)
3%
Red laser movement
Treatment couch
1 mm
i. Digital readout vs. actual movement 1 mm
ii. Level 0.5°
iii. Longitudinal motion alignment 1 mm
iv. Sag 5 mm
MVCT
Geometric distortions 2 mm for non-SRS/SBRT
1 mm for SRS/SBRT
Noise Consistency with baseline
Uniformity Consistency with baseline
Spatial resolution 1.6 mm object
Contrast Consistency with baseline
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No. Parameters Tolerance Frequency
(if MVCT is used for dose calculation)
Uniformity 25HU
HU (water test plug) within ±HU 30 of baseline
HU (lung/bone test plug) within ±HU 30 of baseline
3. Machine Alignment
i. MLC Tongue & Groove Out of focus percentage < 2% Annually
ii. Jaw Shift Calculated IEC Y source position=±0.3 mm
iii. Central axis Y-Axis misalignment Jaw offset =± 0.5 mm
iv. MLC Centre-of-Rotation MLC COR Offset =±1.5mm
MLC twist angle < 0.5 deg
v. Field Centre vs. Jaw Setting Maximum field centre difference < 0.5 mm
vi. Jaw Detector Alignment Centre (IEC-Y) Offset =±2mm
[left offset-right offset] < 2 mm
4. Laser Alignment
i. Green Overhead Laser Level
X-axis divergence < 2 mm over 550 mm vertical displacement
Y-axis divergence < 2 mm over 550 mm vertical displacement
Annually
ii. Green Overhead Laser Alignment
Vertical offset = ±1 mm
Vertical distance <1 mm over 550 mm lateral displacement
iii. Green Bore Laser Level
X-axis divergence <1 mm over 550 mm lateral (IEC X) displacement
Y-axis divergence <1 mm over 550 mm inferior/superior (IEC Y)
displacement
iv. Green Bore Laser Alignment
TomoImage lateral offset (X-axis) <1 mm
TomoImage vertical offset (Z-axis) <1 mm
Overhead-bore laser overlap
<1 mm
Bore-overhead laser twist
< 0.5 mm over 700 mm displacement
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No. Parameters Tolerance Frequency
v. Red Movable Lasers
Red-green laser overlap ±1 mm
Red-green laser twist <1 mm over 550 mm displacement
5. Couch Alignment
i. Couch Level
Couch level ±0.2º in IEC-X and IEC-Y directions
Couch X-axis divergence <2 mm over the vertical motion range
Annually
ii. Couch Alignment
Couch X-axis divergence <1 mm over 700 mm inferior-superior (IEC-
Y) couch displacement
Overhead laser-couch lateral centre=±2 mm when the couch
lateral absolute position is zeroed
iii. Couch sag
Un-weighted couch sag <5 mm over 700 mm inferior-superior (IEC Y)
couch displacement
iv. Couch Cobra Motion
Y-axis divergence ±2 mm over the vertical motion range
6. Beam Output & Profiles
i. Rotational Variation
Output ratio=100±2%
Energy gamma<1.0
Annually
ii. Beam Profiles Verification
a. Transverse profile
25% field width at 15mm depth is <1% difference from beam model created at the factory.
Gamma over a range of 400mm is less than 1 by using a 2% value parameter and 1mm distance parameter.
b. Longitudinal profile 50% field width at 15mm depth is <1% difference from beam model created at the factory.
Gamma over a range of 3 times the field width is less than 1 by using a 2% value parameter and 1mm distance parameter.
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No. Parameters Tolerance Frequency
c. PDD curve
For all field widths commissioned, PDD (IEC Z) profiles are within 2% of beam model values created at the factory from 10mm to 200mm.
iii. Static Output & Energy
Static output: ± 2% of calibrated output during commissioning
Energy: ± 2% of factory data
iv. Monitor Unit Calibration: (Treatment Beam and TomoImage beam)
Measured vs. Displayed (Dose Monitor 1 & 2) Rates: within 2%
Dose monitor 1 vs. Dose monitor 2: within 2%
Expected vs. Cumulative MU: within 2% of each other
7. IMRT Verification
Tomohelical Plan
i. Plan 1:FW50mm;On-Axis Tumour
ii. Plan 2:FW50mm;On-Axis Tumour
iii. Plan 3:FW25mm;On-Axis Tumour
iv. Plan 4:FW25mm;On-Axis Tumour
v. Plan 5:FW10mm;On-Axis Tumour
vi. Plan 6:FW10mm;On-Axis Tumour
Tomodirect Plan*
i. Plan 1:FW50mm;On-Axis Tumour
ii. Plan 2:FW50mm;On-Axis Tumour
iii. Plan 3:FW25mm;On-Axis Tumour
iv. Plan 4:FW25mm;On-Axis Tumour
v. Plan 5:FW10mm;On-Axis Tumour
vi. Plan 6:FW10mm;On-Axis Tumour
Measured doses are within 3% or 3 mm of values predicted by beam
model
Measured doses are within 4% or 3 mm of values predicted by beam
model
Annually
8. TomoImage Verification
i. Image Reconstruction
Image is reconstructed and viewable on the Registration Panel
Annually
ii. Image Resolution
The largest three rows of holes on the resolution plugs are visible.
Each hole in the largest three rows can be distinguished from its
neighbours
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No. Parameters Tolerance Frequency
iii. Image Artefacts
There are no significant ring, streak, and button artefacts in the image
iv. Dose Dose measured for a Fine TomoImage scan <4 cGy
9. Machine Archive
Machine on OS, example of patient archive + FAT, KERNEL and machine files from tomocl1 (Cluster)
Pass/Fail
Annually
* where applicable.
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Jadual 6: Cyberknife
No. Parameters Tolerance Frequency
1. i. System status Passed/Failed Daily
ii. Safety checks
a) Door interlock (beam off)
b) Audiovisual monitor
Functional
Functional
iii. Collimator assembly collision detector Functional
iv. Detection of incorrect and missing collimator
Functional
v. LINAC output constancy check < 2%
vi. Robot mastering (perch position laser) check
< 1mm
vii. AQA targeting reproducibility test < 1mm from baseline
2. i. Absolute dose 2%
Monthly
ii. X-ray energy
a. Depth of dmax
b. Percent depth dose at D10cm (PDD10)
± 2mm from baseline (40mm collimator)
± 2% from baseline
(40mm collimator)
iii. Flatness < 18% (40mm collimator)
iv. Symmetry < 2% (40mm collimator)
v. Penumbra < 4.5mm (40mm collimator)
vi. LINAC/radiation field alignment
< 1mm at 800mm SAD
vii. Alignment of room lasers ≤ 2mm
viii. Imaging system alignment ≤ 1mm of centre crosshairs or ± 2 pixels
ix. Visual targeting test Laser on isocrystal for each node
x. Treatment couch positioning check
a. Head Up/Down at Home
b. Roll Left/Right at Home
c. Left/Right at Home
0 ± 0.30
0 ± 0.30
< 5mm from centre
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No. Parameters Tolerance Frequency
xi. Imaging system bad pixel statistics Bad pixels less than maximum limit, number and
position
Quarterly
xii. TLS tracking and couch movement correspondence
a. Left/Right ± 2mm
b. Anterior/Posterior ± 2mm
c. Inferior/Superior ± 2mm
d. Roll Left/Right ± 0.3º
e. Head Up/Down ± 0.3º
f. RMS error ≤ 2mm
xiii. Treatment delivery targeting accuracy (End to End Test) (Total targeting error)
< 0.95mm or < 1.5mm for Motion Tracking System
xiv. CT geometric accuracy ≤ 1mm
xv. Treatment delivery dose accuracy < 5% (Typically about ± 2%)
xvi. Iris collimator aperture size check
Yes/No
3. i. Commissioning beam data spot checks (Water Phantom measurements)
a. X-ray energy See 2 (ii) above Annually
b. Absolute dose 2%
c. Dose rate As per LINAC specification
d. Tissue Phantom Ratio (TPR) 2% from baseline
e. Off Centre Ratio (OCR) 2% from baseline
f. Output Factor (OF) 2% from baseline
g. Flatness See 2 (iii) above
h. Symmetry See 2 (iv) above
i. Penumbra See 2 (v) above
ii. Collimator transmission 1%
iii. Dosimetry precision ± 2%
iv. Linearity
a. Requested MU = 10
b. Requested MU = 20
c. Requested MU = 30
d. Requested MU = 40
e. Requested MU = 50
f. Requested MU = 100 to 1000
± 6%
± 4%
± 3%
± 2%
± 1.5%
± 1%
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No. Parameters Tolerance Frequency
v. Linac output rotational stability test ± 2%
vi. TPS beam data spot checks ± 2% of measured beam data
vii. Interlocks and safety system tests Functional
viii. Data security and verification
Functional
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Jadual 7: Brachytherapy
Jadual 7.a: Remote Afterloading Brachytherapy Unit
* It is worthwhile at source change to calibrate both new and old sources to establish and document reproducibility of calibration method.
No. Parameters Tolerance Frequency
1. i. Room safety door interlocks, lights, and alarms
Functional Each treatment day
ii. Console functions, switches, batteries, printers
Functional
iii. Visual inspection of source guides Free of kinks and firmly attached
iv. System self test Functional
2. i. Source positioning
ii. Timer function
iii. Check accuracy of source guides and connectors
1 mm
1%
1 mm
Each treatment day or Weekly
3. Source strength calibration* 3% Each source change or Annually
4. Accuracy of source and dummy loading (dummies used for spacing and/or simulation/ verification)
1 mm Annually
5. Simulate emergency conditions Functional Annually
6. Verify source inventory Performed Annually
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Jadual 7.b: Special Procedures for Permanent Interstitial Brachytherapy
No. Parameters Tolerance Frequency
1. Safety and Radiation Protection
i. Emergency equipment (forceps, tweezers, emergency safe, survey meter)
Available Before the start of implant
ii. Source preparation area survey
Performed
iii. Survey monitor Functional Before the start of implant or Annually
iv. Hand held monitor Functional
v. Protective material, lead aprons Functional
vi. Source inventory Available Semi-Annually
vii. Radiation survey for stray seeds Performed Upon completion of procedure
viii. Monitor sources lost from the patient Performed Upon discharge
2.
Physical Parameters
i. Source calibration, mean of batch
ii. Source calibration, individual source
iii. Source identification
iv. Grid calibration in ultrasound system
Maximum 3%
Maximum 5%
Verification
Performed
Before the start of implant
Before the start of implant or
Quarterly
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Jadual 8: Treatment Planning System for Teletherapy
No. Parameters Tolerance Frequency
1.
Checksum of program files no change Weekly
2. Photon beam dosimetry
i. Monitor unit calculation 1% Monthly
ii. Standard treatment plan outputs 1% Quarterly
iii. Point dose calculations and factor (PDD,TMR etc for open and irregular fields)
2% Annually
iv. Beam profiles (including open, wedged and asymmetric beams)
2% Annually
v. Inverse square law correction 2% Annually
vi. Wedge and transmission factors 2% Annually
3. Electron beam dosimetry
i. Monitor unit calculation 1% Monthly
ii. Standard treatment plan outputs 1% Quarterly
iii. Point dose calculations and factors (PDD for open and irregular fields)
2% Annually
iv. Beam profiles 2% Annually
v. Inverse square law correction 2% Annually
vi. Beam size 2 mm Annually
4. Peripheral devices
i. Printing/Plotting device/ Film scanner/ Block cutting device/ Digitizer
a. transfer of geometric figures Intact Monthly
b. transfer of geometric dimensions 1 mm Monthly
c. transfer of geometric orientations Intact Monthly
ii. CT Interface
a. transfer of geometric figures Intact Monthly
b. transfer of geometric dimensions 1 mm Monthly
c. transfer of geometric orientations Intact Monthly
d. electron density compared to known densities in water
10% Monthly
iii. Archiving and retrieving of patient data Intact Semi-annually
iv. Network data transfer Intact Semi-annually
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Jadual 9: Imaging Systems
(Portal Imaging and Image Guided Radiation Therapy)
No. Parameters Tolerance
Non-SRS/SBRT
Tolerance
SRS/SBRT
Frequency
1. Planar kV and MV (EPID) imaging
i. Collision interlocks Functional Functional Daily
ii. Positioning/repositioning ≤2 mm ≤1 mm Daily
iii. Imaging and treatment coordinate coincidence (single gantry angle)
≤2 mm ≤1 mm Weekly
Cone-beam CT (kV and MV)
i. Collision interlocks Functional Functional Daily
ii. Positioning/repositioning ≤1 mm ≤1 mm Daily
iii. Imaging and treatment coordinate coincidence
≤2 mm ≤1 mm Weekly
2. Planar MV imaging (EPID)
i. Imaging and treatment coordinate coincidence (four cardinal angles)
≤2 mm ≤1 mm
Semi-Annually
ii. Scaling ≤2 mm ≤2 mm
iii. Spatial resolution Baseline* Baseline
iv. Contrast Baseline Baseline
v. Uniformity and noise Baseline Baseline
Planar kV imaging
i. Imaging and treatment coordinate coincidence (four cardinal angles)
≤2 mm ≤1 mm
ii. Scaling ≤2 mm ≤1 mm
iii. Spatial resolution Baseline Baseline
iv. Contrast Baseline Baseline
v. Uniformity and noise Baseline Baseline
Cone-beam CT (kV and MV)
i. Geometric distortion ≤2 mm ≤1 mm
ii. Spatial resolution Baseline Baseline
iii. Contrast Baseline Baseline
iv. HU constancy Baseline Baseline
v. Uniformity and noise Baseline Baseline
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No. Parameters Tolerance
Non-SRS/SBRT
Tolerance
SRS/SBRT
Frequency
3. Planar MV imaging (EPID)
Full range of travel SDD ±5 mm ±5 mm Annually
Imaging dose Baseline Baseline
Planar kV imaging
Beam quality/energy Baseline Baseline
Imaging dose Baseline Baseline
Cone-beam CT (kV and MV)
Imaging dose Baseline Baseline
*Baseline means that the measured data are consistent with acceptance testing data.
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Jadual 10: Intra-operative Radiation Therapy (Low kV Photon)
No. Parameters Tolerance Frequency
1. Radiation Safety
i. Radiation on/off warning light
ii. Survey meter
iii. Mobile Lead Shield
iv. X-ray source calibration certificate
v. Ionization chamber calibration certificate
Functional
Available and Functional
Available
Valid
Valid
Before each treatment
day
2. Infection Safety
Sterilization* for Interstitial Treatment:
i. Photodiode array
ii. X-ray source
iii. Probe adjuster/ion chamber holder
iv. External Radiation Monitor (if used)
v. X-ray source and probe adjuster/ion chamber holder cables
vi. Verification block (V block)
vii. X-ray source holding block (X block)
viii. Sterilization tray
Manufacturer’s specifications
Before each case
3. Quality Assurance System
i. Integrity of applicators (visual check)
ii. X-ray probe straightness
iii. Electron beam dynamic offset
iv. Source isotropy
v. Internal Radiation Monitor
vi. Source dose rate (Gy/min)
Satisfactory
< 0.1 mm
< 1 mm
< 10 %
+5 % (from initial value)
< 5 % from certificate
Before each case or Monthly
4. Radiation Safety Checks
i. Ion chamber calibration
ii. X-Ray Source Output Factor Calibration
iii. Percent Depth Dose for all applicators
iv. Radiation anisotropy at 10 mm from surface for all applicators
v. Radiation leakage at 10 cm from properly shielded** source
Local authority
Manufacturer specification
Manufacturer specification
< 5 %
< 0.5 %
Annually
* Sterilization not mandatory for tumour bed treatment
** With PDA (photodiode array) in place