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Page 1: KEMENTERIAN KESIHATAN MALAYSIAradia.moh.gov.my/project/new/radia/FileTransfer... · DEFINISI Central axis The imaginary axis or line which passes through both the x-ray source and
Page 2: KEMENTERIAN KESIHATAN MALAYSIAradia.moh.gov.my/project/new/radia/FileTransfer... · DEFINISI Central axis The imaginary axis or line which passes through both the x-ray source and
Page 3: KEMENTERIAN KESIHATAN MALAYSIAradia.moh.gov.my/project/new/radia/FileTransfer... · DEFINISI Central axis The imaginary axis or line which passes through both the x-ray source and

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