Untitled - Seksyen Keselamatan Sinaran

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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
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.
1
2.
OBJEKTIF
Objektif pelaksanaan QAP dalam perkhidmatan radioterapi adalah :
2.1
2.2
2.3
2.4
3.
Meningkatkan kualiti perkhidmatan radioterapi
Memastikan ketepatan dan kejituan dalam rawatan pesakit
Memastikan penggunaan sumber yang sedia ada secara efektif dan selamat
Memenuhi dan mematuhi keperluan peraturan-peraturan di bawah Akta
Perlesenan Tenaga Atom 1984 (Akta 304)
PELAKSANAAN QAP SEBAGAI KEPERLUAN REGULATORI
QAP hendaklah dilaksanakan di setiap pusat radioterapi dengan merangkumi elemenelemen 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.
2
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.
3
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 nonionising 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
measurement from its desired value.
4
in
a
parameter
or
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/cm 2
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
Tissue Maximum Ratio in water at depths of 20 g/cm2 and 10 g/cm2
WF
Wedge Factor
10
5
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.
6
LAMPIRAN A
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%
7
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.
8
Form A
MONTH: ...................
PORTAL VERIFICATION FORM
No.
Patient
IC No.
Date
Start
treatment
Acquisition
Method of
image
acquisition
Treatment
site
Set up
errors
(mm)
Accepted (/)/
Rejected (X)
*Type of
verification
errors
Remarks
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)
Prepared by : ...............................
(Signature & Cop)
Date
9
: .............................
Form B
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
* The rate of discrepancies (%) 
Total number of rejected images
 100%
Total number of verificati on images being taken
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)
10
LAMPIRAN B
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
: Brachytherapy
Jadual 7.a
: Remote Afterloading Brachytherapy Unit
Jadual 7.b
: 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)
11
Jadual 1: Simulator
No.
1.
Parameters
Mechanical Checks
i. Localising lasers
ii. Optical Distance Indicator (ODI)
iii. Field size indicator
Radiation Safety Checks
i. Radiation on/off warning light
ii. Emergency button
2.
3.
Mechanical Checks
i. Gantry/collimator angle indicators
ii. Cross-hair centring
iii. Focal spot-axis indicator
iv. Emergency/collision avoidance
v. Light/radiation field coincidence
vi. Collimator rotation isocentre
vii. Gantry rotation isocentre
viii. Couch rotation isocentre
ix. Coincidence of collimator, gantry,
couch axes and isocentre
x. Table top sag
xi. Vertical travel of couch
Frequency
2 mm
2 mm
2 mm
Daily
Functional
Functional
Daily
Quarterly
1º
2 mm diameter
2 mm
Functional
2 mm or 1%
2 mm diameter
2 mm diameter
2 mm diameter
2 mm diameter
Monthly
2 mm
2 mm
Radiographic and Fluoroscopic Checks
i. Exposure reproducibility
ii. Exposure linearity
iii. kVp accuracy
iv. High and low contrast resolution
v. Image Receptor Input Dose Rate
vi. Entrance Surface Dose Rate Limit
a. Equipment with AEC
b. Equipment without AEC
vii. Leakage radiation
4.
Tolerance
10%
10%
5% or 5kV whichever is
greater
Baseline
Manufacturer’s Specification
<100mGy per minute
<50mGy per minute
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)
<0.1mGy (10mR) in a week
Scattered radiation
12
Annually or
after
maintenance
services*
Annually
* 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.
13
Jadual 2: CT Simulator
No.
1.
Parameters
Mechanical Checks
Localising lasers
ii. Emergency button
2.
3.
4.
X-Ray Generator
i. Accuracy of kVp
ii. Accuracy of exposure time
iii. Exposure linearity (mR/mAs)
iv. Radiation output reproducibility
Radiation Dosimetry
i. Patient dosimetry (CTDI)
ii. Scout localisation image
Scan Localisation
i. Axial scan localisation light
accuracy
ii. Isocentre alignment, sagittal and
coronal localisation light accuracy
iii.
iv.
v.
vi.
Gantry tilt accuracy
Table index
Table position
Image scan width (sensitivity
profile)
a. Single slice
Frequency
2mm
Daily
Functional
Functional
Daily
Quarterly
± 5% or 5kV (whichever is greater)
± 10%
Coefficient of linearity ≤ 0.1
Coefficient of variation ≤ 0.1
Annually
Manufacturer specifications
±20% of nominal value
Annually
±2 mm
Annually
±5 mm
±3º
±0.5 mm
±2.0 mm
±0.5 mm (<5 mm prescribed scan
width)
±1 mm (≥5 mm prescribed scan
width)
b. Multi slice
5.
Tolerance
Image Display
i. Visual display
Luminance and contrast not
significantly different from hard
copy;
Geometric distortion not exceed
±1 mm.
14
Daily
Monthly
No.
6.
Parameters
ii. Hard copy display
Tolerance
5% and 95% patches must be
visible, no noticeable artefacts;
Geometric distortion not exceed
±1 mm;
Optical density values must be
within specified range.
Image Quality
i. CT number uniformity
±5 HU
ii. Image artefacts (transaxial and
scan localisation images
iii. Noise
Quantitative Accuracy
i. CT number constancy
ii. CT number calibration
iii. Accuracy of distance
measurements (transaxial and
scan localisation images)
iv. CT number dependence on scan
thickness
v. CT number dependence on
phantom size
8.
Monthly
No significant artefacts
iv. Low contrast resolution
v. High contrast resolution
7.
Frequency
Annually
Standard deviation of CT numbers
varies as reciprocal square root of
mAs
SemiAnnually
5 mm
1 mm holes (5lp/cm)
Annually
Annually
Value and standard deviation for
water remains relatively constant
Water : 0 ± 5HU
±1 mm
Daily
Monthly
Annually
± 3HU
± 20HU
vi. CT number dependence on
phantom position
± 5HU
vii. CT number dependence on
reconstruction algorithm
± 3HU
Scattered and Leakage Radiation
i. Scattered radiation
<0.1mGy (10mR) per week
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)
15
Annually
No.
9.
Parameters
External Localisation Laser
Orientation of gantry lasers with respect
to the imaging plane
Tolerance
Frequency
±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
projection
Orientation of the ceiling laser with
respect to the imaging plane
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
16
Jadual 3: Irradiating Apparatus below 1 MV
No.
1.
2.
3.
Parameters
Mechanical Checks
i. Mechanical integrity of the unit
ii. Firmness of the locking devices
i. Door interlock
ii. Radiation on/off warning light
iii. Emergency button
iv. Locking devices
Dosimetry
i. Absolute dose
ii. HVL test
iii. Beam homogeneity film test
iv. Cut out lead transmission factors
Frequency
Functional
Functional
Quarterly
Functional
Functional
Functional
Functional
Daily
Daily
Quarterly
Quarterly
Standard recognised by
the appropriate authority
v. Light/radiation field coincidence
4.
Tolerance
±2 mm or 2%
i. Tube head leakage
a) Contact therapy
1 mGy per hour at 5 cm
from the tube housing
Semi-Annually
Semi-Annually
Semi-Annually
Every new batch
of lead
Semi-Annually
Tube head
change or
service
10 mGy per hour at 1 m
from the source
b) < 500 kVp
0.1 percent of useful
beam or 10 mGy per
hour, whichever is greater
at 1 m from the source
c) 500 kVp - 999 kVp
ii. Applicator geometrical accuracy and
beam axis indication on rotation
iii. Dose monitor reproducibility
iv. Dose monitor linearity
v. Output consistency
17
< 2 mm
Quarterly
< 0.5%
 2%
 3%
Quarterly
Quarterly
Quarterly
Jadual 4: Linear Accelerator
No.
1.
Parameters
Mechanical Checks
i. Localising lasers
ii. Optical Distance Indicator (ODI)
iii. Field light
Safety Checks
i. Door Interlock
ii. Audiovisual monitor
2.
3.
Mechanical Checks
i. Light/radiation field coincidence
ii. Gantry/collimator angle indicators
iii. Wedge position
Tray position
Applicator position
Field size indicators
Cross-hair centring
Treatment couch position indicators
Latching of wedges, blocking tray
Jaw symmetry
Safety Checks
i. Emergency off switches
ii. Wedge, electron cone interlocks
4.
Frequency
2 mm
2 mm
Functional
Daily
Functional
Functional
Dosimetry
i. X-ray output constancy
ii. Electron output constancy
iii. X-ray beam flatness constancy
iv. Electron beam flatness constancy
v. X-ray and electron symmetry
vi. Backup monitor constancy
iv.
v.
vi.
vii.
viii.
ix.
x.
Tolerance
2%
2%
2%
3%
3%
2%
2 mm for field up to 20 cm or
± 1% for field over 20 cm
1 deg
2 mm (or 2% change in
transmission factor)
2 mm
2 mm
2 mm
2 mm diameter
2mm/1 deg
Functional
2 mm
Weekly
Quarterly
Monthly
Functional
Functional
Dosimetry
i. X-ray/electron output calibration
constancy
2%
ii. Photon central axis parameter
constancy (PDD, TAR)
2%
18
Annually
No.
Parameters
iii. Electron central axis dosimetry
parameter constancy (PDD)
Tolerance
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
vii. Electron output constancy vs. gantry
angle
2%
2%
viii. Wedge transmission factor constancy
ix. Monitor chamber linearity
x. Transmission factor constancy for all
treatment accessories
xi. Arc mode
2%
1%
2%
Safety Interlocks
Follow manufacturers test procedures
Frequency
Manufacturers’ specification
Functional
Mechanical Checks
i. Collimator rotation isocentre
ii. Gantry rotation isocentre
iii. Couch rotation isocentre
iv. Coincidence of collimator, gantry, couch
axes with isocentre
v. Coincidence of radiation and
mechanical isocentre
vi. Table top sag
vii. Vertical travel of table
Scattered radiation
2 mm diameter
2 mm diameter
2 mm diameter
2 mm diameter
2 mm diameter
2 mm
2 mm
< 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.
19
Jadual 4.a: Additional QC Parameters for LINAC-Based Stereotactic
Radiosurgery/Radiotherapy (SRS/SRT)
No.
1.
Parameters
Laser localisation check
2.
Winston Lutz test
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
4.
5.
6.
7.
Patient-specific treatment
verification (Image Guided)
i. For SRS treatment
ii. For SRT treatment
Tolerance
1 mm
Frequency
Daily
1.5 mm
Weekly (SRT)/
Before
treatment (SRS)
Pass/fail
Before first
treatment for
each patient
Before each
fraction
1 mm
2 mm
Safety Check
Stereotactic interlocks
Before
treatment
Functional
Daily
Dosimetry
Typical dose rate output constancy
2%
Monthly
Mechanical
Treatment couch position indicators
1 mm/0.5°
Dosimetry
i. SRS arc rotation mode
(range: 0.5-10MU/deg)
ii. X-ray monitor unit linearity
(output constancy)
Monitor units set vs. delivered:
1 MU or 2% (whichever is greater)
Gantry arc set vs. delivered:
1° or 2% (whichever is greater)
±5% for 2 - 4 MU
±2% for ≥ 5 MU
Mechanical Checks
i. Coincidence of radiation and
mechanical isocentre
ii. Stereotactic accessories, lockouts,
etc.
±1 mm from baseline
Functional
20
Annually
Jadual 4.b: Additional QC Parameters for LINAC-Based
Intensity Modulated Radiation Therapy (IMRT)
No.
1.
Parameters
Individual patient plan verification
2.
Mechanical Check
Laser localisation
3.
Dosimetry
i. Typical dose rate output constancy
ii. Photon beam profile constancy
Mechanical Checks
i. Distance check device for lasers
compared with front pointer
ii. Accessory trays (i.e., port film graticule
tray)
iii. Cross-hair centring (walkout)
iv. Localising lasers
4.
Tolerance
±5% (point dose), other per
clinical significance
Frequency
Before first
treatment
1.5 mm
Daily
2% (@ IMRT dose rate)
1%
Monthly
1 mm
2 mm
1 mm (diameter)
±1 mm
*Safety Check
Laser guard-interlock test
Functional
*Respiratory Gating
Beam output constancy
i. Phase, amplitude beam control
ii. In room respiratory monitoring system
iii. Gating Interlock
2%
Functional
Functional
Functional
Dosimetry
i.
X-ray flatness change from baseline
ii. X-ray symmetry change from baseline
iii. X-ray output calibration
iv. Spot check of field size dependent output
factors for x ray(two or more FSs)
v.
20
X-ray beam quality (PDD10 or TMR 10
)
vi.
X-ray monitor unit linearity (output
constancy)
vii. X-ray output constancy vs. dose rate
viii. X-ray output constancy vs. gantry angle
ix. Arc mode (expected MU, deg)
21
1%
±1%
±1% (absolute)
2% for field size <4x4 cm2,
1% for field size ≥4x4 cm2
±1% from baseline
±5% (2–4 MU)
±2% ≥5 MU
±2% from baseline
±1% from baseline
±1% from baseline
Annually
No.
Parameters
Tolerance
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
22
Frequency
Jadual 4.b.i: Additional QC Parameters for Multi-leaf Collimation
(With differentiation of IMRT vs. non-IMRT machines)
No.
1.
Parameters
Qualitative test (i.e., matched
segments, also known as ―picket
fence‖)
2.
i. Setting vs. radiation field for two
patterns (non-IMRT)
ii. Travel speed (IMRT for sliding
window technique)
iii. Leaf position accuracy (IMRT)
3.
Tolerance
Visual inspection for discernable
deviations from expected leaf
position
Frequency
Monthly
(IMRT
machines)
2 mm
Monthly
Loss of leaf speed > 0.5cm/s
1 mm for leaf positions of an
IMRT field for four cardinal gantry
angles*
i. MLC transmission (average of leaf
and interleaf transmission), all
energies
ii. Leaf position repeatability
iii. MLC spoke shot
iv. Coincidence of light field and x-ray
field (all energies)
±0.5% from baseline
Annually
±1.0 mm
≤1.0 mm radius
±2.0 mm
v. Segmental IMRT (step and shoot)
test
vi. Moving window IMRT (four cardinal
gantry angles)
<0.35 cm max. error RMS, 95%
of error counts <0.35 cm
<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.
23
Jadual 4.b.ii: Additional QC Parameters for Dynamic/universal/virtual wedges
No.
Parameters
Dynamic
N/A*
Tolerance
Universal
Functional
Frequency
Virtual
N/A*
Central axis
45º or 60º
WF (within
2%)
5% from
unity,
otherwise
2%
1.
Morning check-out run for
one angle
2.
Wedge factor for all energies
Central axis
45º or 60º
WF (within
2%)
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%
*N/A – Not applicable
24
Daily
Monthly
Annually
Jadual 5: Helical Tomotherapy
No.
1.
Parameters
i. Output – rotational or static
ii. Image/laser coordinate coincidence
iii. Image registration/alignment
iv. Red laser initialization
Tolerance
3%
2 mm for non-SRS/SBRT
1 mm for SRS/SBRT
1mm
1.5 mm for non-SRS/SBRT
1 mm for SRS/SBRT
Frequency
Daily
Functional
Functional
i. Door Interlock
ii. Audiovisual monitor
2.
Beam parameters
Output—Static
Output—Rotational
Monitor chamber constancy
Rotation output variation
Beam quality
2%
2%
2%
2%
20
1% PDD10 or TMR 10
Transverse profile
Longitudinal profiles (each slice width)
1% average difference in field core
1% of slice width at FWHM
Alignment and Miscellaneous
Interrupted procedure
(agreement with uninterrupted
procedure)
Red laser movement
Treatment couch
i. Digital readout vs. actual movement
ii. Level
iii. Longitudinal motion alignment
iv. Sag
MVCT
Geometric distortions
3%
1 mm
1 mm
0.5°
1 mm
5 mm
2 mm for non-SRS/SBRT
1 mm for SRS/SBRT
Consistency with baseline
1.6 mm object
Noise
Uniformity
Spatial resolution
Contrast
25
Monthly
No.
3.
Parameters
(if MVCT is used for dose calculation)
Uniformity
HU (water test plug)
HU (lung/bone test plug)
Tolerance
25HU
within ±HU 30 of baseline
within ±HU 30 of baseline
Machine Alignment
i. MLC Tongue & Groove
ii. Jaw Shift
iii. Central axis Y-Axis misalignment
iv. MLC Centre-of-Rotation
v. Field Centre vs. Jaw Setting
vi. Jaw Detector Alignment
4.
Frequency
Laser Alignment
i. Green Overhead Laser Level
ii. Green Overhead Laser Alignment
Out of focus percentage < 2%
Calculated IEC Y source
position=±0.3 mm
Jaw offset =± 0.5 mm
MLC COR Offset =±1.5mm
MLC twist angle < 0.5 deg
Maximum field centre difference <
0.5 mm
Centre (IEC-Y) Offset =±2mm
[left offset-right offset] < 2 mm
Annually
X-axis divergence < 2 mm over 550
mm vertical displacement
Y-axis divergence < 2 mm over 550
mm vertical displacement
Annually
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
26
No.
Parameters
v. Red Movable Lasers
5.
Couch Alignment
i. Couch Level
Frequency
Couch level ±0.2º in IEC-X and IECY 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 (IECY) 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
6.
Tolerance
Red-green laser overlap ±1 mm
Red-green laser twist <1 mm over
550 mm displacement
Y-axis divergence ±2 mm over the
vertical motion range
Beam Output & Profiles
i. Rotational Variation
Output ratio=100±2%
Energy gamma<1.0
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.
27
Annually
No.
Parameters
c. PDD curve
Tolerance
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
Frequency
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.
8.
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
Measured doses are within 3% or 3
mm of values predicted by beam
model
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
TomoImage Verification
i. Image Reconstruction
Annually
Measured doses are within 4% or 3
mm of values predicted by beam
model
Image is reconstructed and
viewable on the Registration Panel
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
28
Annually
No.
Parameters
iii. Image Artefacts
Tolerance
There are no significant ring, streak,
and button artefacts in the image
iv. Dose
9.
Frequency
Dose measured for a Fine
TomoImage scan <4 cGy
Machine Archive
Machine on OS, example of patient
archive + FAT, KERNEL and machine
files from tomocl1 (Cluster)
* where applicable.
29
Pass/Fail
Annually
Jadual 6: Cyberknife
No.
1.
vii.
Parameters
System status
Safety checks
a) Door interlock (beam off)
b) Audiovisual monitor
Collimator assembly collision detector
Detection of incorrect and missing
collimator
LINAC output constancy check
Robot mastering (perch position
laser) check
AQA targeting reproducibility test
i.
Absolute dose
ii.
X-ray energy
a. Depth of dmax
i.
ii.
iii.
iv.
v.
vi.
2.
Flatness
v.
< 2%
< 1mm
< 1mm from baseline
± 2mm from baseline (40mm
collimator)
± 2% from baseline
(40mm collimator)
< 18% (40mm collimator)
iv. Symmetry
< 2% (40mm collimator)
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
30
Frequency
Daily
Functional
Functional
Functional
Functional
2%
b. Percent depth dose at D10cm (PDD10)
iii.
Tolerance
Passed/Failed
0 ± 0.30
0 ± 0.30
< 5mm from centre
Monthly
No.
xi.
Parameters
Imaging system bad pixel statistics
xii. TLS tracking and couch movement
correspondence
a. Left/Right
b. Anterior/Posterior
c. Inferior/Superior
d. Roll Left/Right
e. Head Up/Down
f. RMS error
xiii. Treatment delivery targeting accuracy
(End to End Test) (Total targeting error)
Frequency
Quarterly
± 2mm
± 2mm
± 2mm
± 0.3º
± 0.3º
≤ 2mm
< 0.95mm or < 1.5mm for
Motion Tracking System
≤ 1mm
xiv. CT geometric accuracy
3.
Tolerance
Bad pixels less than
maximum limit, number and
position
xv. Treatment delivery dose accuracy
< 5% (Typically about ± 2%)
xvi. Iris collimator aperture size check
Yes/No
i. Commissioning beam data spot checks
(Water Phantom measurements)
a. X-ray energy
b. Absolute dose
c. Dose rate
d. Tissue Phantom Ratio (TPR)
e. Off Centre Ratio (OCR)
f. Output Factor (OF)
g. Flatness
h. Symmetry
i. Penumbra
ii. Collimator transmission
iii. Dosimetry precision
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
See 2 (ii) above
2%
As per LINAC specification
2% from baseline
2% from baseline
2% from baseline
See 2 (iii) above
See 2 (iv) above
See 2 (v) above
1%
± 2%
± 6%
± 4%
± 3%
± 2%
± 1.5%
± 1%
31
Annually
No.
Parameters
v. Linac output rotational stability test
vi. TPS beam data spot checks
Tolerance
± 2%
± 2% of measured beam
data
vii. Interlocks and safety system tests
Functional
viii. Data security and verification
Functional
32
Frequency
Jadual 7: Brachytherapy
Jadual 7.a: Remote Afterloading Brachytherapy Unit
No.
1.
Parameters
i. Room safety door interlocks, lights, and
alarms
ii. Console functions, switches, batteries,
printers
iii. Visual inspection of source guides
Frequency
Each treatment day
Functional
Free of kinks and
firmly attached
Functional
iv. System self test
2.
Tolerance
Functional
i. Source positioning
1 mm
ii. Timer function
Each treatment day
or Weekly
1%
iii. Check accuracy of source guides and
connectors
1 mm
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
*
It is worthwhile at source change to calibrate both new and old sources to establish and document
reproducibility of calibration method.
33
Jadual 7.b: Special Procedures for Permanent Interstitial Brachytherapy
No.
1.
2.
Parameters
Safety and Radiation Protection
i. Emergency equipment (forceps, tweezers,
emergency safe, survey meter)
ii. Source preparation area survey
Tolerance
Frequency
Available
Before the start of
implant
iii.
Survey monitor
Functional
iv.
v.
vi.
vii.
Hand held monitor
Protective material, lead aprons
Source inventory
Radiation survey for stray seeds
Functional
Functional
Available
Performed
viii. Monitor sources lost from the patient
Performed
Physical Parameters
i.
Source calibration, mean of batch
ii. Source calibration, individual source
iii. Source identification
Maximum 3%
Maximum 5%
Verification
Before the start of
implant
Performed
Before the start of
implant or
Quarterly
iv.
Grid calibration in ultrasound system
34
Performed
Before the start of
implant or Annually
Semi-Annually
Upon completion of
procedure
Upon discharge
Jadual 8: Treatment Planning System for Teletherapy
No.
1.
Parameters
Checksum of program files
2.
Photon beam dosimetry
i. Monitor unit calculation
ii. Standard treatment plan outputs
iii. Point dose calculations and factor (PDD,TMR
etc for open and irregular fields)
iv. Beam profiles (including open, wedged and
asymmetric beams)
v. Inverse square law correction
vi. Wedge and transmission factors
3.
4.
Tolerance
no change
Frequency
Weekly
1%
1%
2%
Monthly
Quarterly
Annually
2%
Annually
2%
2%
Annually
Annually
Electron beam dosimetry
i. Monitor unit calculation
ii. Standard treatment plan outputs
iii. Point dose calculations and factors (PDD for
open and irregular fields)
iv. Beam profiles
v. Inverse square law correction
vi. Beam size
1%
1%
2%
Monthly
Quarterly
Annually
2%
2%
2 mm
Annually
Annually
Annually
Peripheral devices
i. Printing/Plotting device/ Film scanner/ Block
cutting device/ Digitizer
a. transfer of geometric figures
b. transfer of geometric dimensions
c. transfer of geometric orientations
Intact
1 mm
Intact
Monthly
Monthly
Monthly
ii. CT Interface
a. transfer of geometric figures
b. transfer of geometric dimensions
c. transfer of geometric orientations
d. electron density compared to known densities
in water
Intact
1 mm
Intact
10%
Monthly
Monthly
Monthly
Monthly
iii. Archiving and retrieving of patient data
iv. Network data transfer
Intact
Intact
Semi-annually
Semi-annually
35
Jadual 9: Imaging Systems
(Portal Imaging and Image Guided Radiation Therapy)
No.
1.
Parameters
Tolerance
Non-SRS/SBRT
Tolerance
SRS/SBRT
Frequency
Functional
≤2 mm
≤2 mm
Functional
≤1 mm
≤1 mm
Daily
Daily
Weekly
Functional
≤1 mm
≤2 mm
Functional
≤1 mm
≤1 mm
Daily
Daily
Weekly
≤2 mm
≤1 mm
SemiAnnually
≤2 mm
Baseline*
Baseline
Baseline
≤2 mm
Baseline
Baseline
Baseline
≤2 mm
≤1 mm
≤2 mm
≤1 mm
Spatial resolution
Contrast
Baseline
Baseline
Baseline
Baseline
Uniformity and noise
Baseline
Baseline
≤2 mm
Baseline
≤1 mm
Baseline
HU constancy
Baseline
Baseline
Baseline
Baseline
Baseline
Baseline
Planar kV and MV (EPID) imaging
i. Collision interlocks
ii. Positioning/repositioning
iii. Imaging and treatment coordinate
coincidence (single gantry angle)
Cone-beam CT (kV and MV)
i. Collision interlocks
ii. Positioning/repositioning
iii. Imaging and treatment coordinate
coincidence
2.
Planar MV imaging (EPID)
i. Imaging and treatment coordinate
coincidence (four cardinal angles)
ii.
iii.
iv.
v.
Scaling
Spatial resolution
Contrast
Planar kV imaging
i. Imaging and treatment coordinate
coincidence (four cardinal angles)
ii.
iii.
iv.
v.
Scaling
i.
ii.
iii.
iv.
v.
Geometric distortion
Spatial resolution
Contrast
36
No.
3.
Parameters
Tolerance
Non-SRS/SBRT
Tolerance
SRS/SBRT
Frequency
Planar MV imaging (EPID)
Full range of travel SDD
Imaging dose
±5 mm
Baseline
±5 mm
Baseline
Annually
Planar kV imaging
Beam quality/energy
Imaging dose
Baseline
Baseline
Baseline
Baseline
Imaging dose
Baseline
Baseline
*Baseline means that the measured data are consistent with acceptance testing data.
37
Jadual 10: Intra-operative Radiation Therapy (Low kV Photon)
No.
1.
2.
3.
4.
Parameters
Radiation Safety
ii. Survey meter
iii. Mobile Lead Shield
iv. X-ray source calibration certificate
v. Ionization chamber calibration certificate
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
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)
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
* Sterilization not mandatory for tumour bed treatment
** With PDA (photodiode array) in place
38
Tolerance
Frequency
Functional
Available and Functional
Available
Valid
Valid
Before each
treatment
day
Manufacturer’s
specifications
Before each
case
Satisfactory
< 0.1 mm
< 1 mm
< 10 %
+5 % (from initial value)
< 5 % from certificate
Before each
case or
Monthly
Local authority
Manufacturer specification
Manufacturer specification
<5%
Annually
< 0.5 %

Untitled - Seksyen Keselamatan Sinaran

Transcription

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