manual program jaminan mutu dalam perkhidmatan radioterapi

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 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 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 

Gating 

Image acquisition 

Image registration 

Intact 

Integrity 

Isocentre 

Set-up errors (field 

placement errors) 

Systematic errors 

The imaginary axis or line which passes through both the x-ray 

source and the isocentre of the machine. 

Gating or respiratory gating is a treatment delivery technique 

which allows the treatment of tumours at certain defined points 

in the respiratory cycle. 

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. 

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. 

Describes something that is complete and that has not been 

damaged in any way. 

The absence of unintended changes or errors. 

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. 

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. 

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. 

4


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 

PDD 10 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 

TMR 20 

WF 

10 

Tissue Maximum Ratio in water at depths of 20 g/cm 2 and 10 g/cm 2 

Wedge Factor 

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 

AREA OF CONCERN 

INDICATOR 

: Radiotherapy Services 

: Performance Quality and Radiation Safety of Radiotherapy 

Services 

: 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 

NUMERATOR 

DENOMINATOR 

: This is a rate-based indicator. 

It is a measure of clinical, physics and maintenance services. 

: Total number of rejected verification images 

: 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 


PORTAL VERIFICATION FORM 

MONTH: ................... 

No. 

Patient 

IC No. 

Start 

treatment 

Date 

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) 

9 

Date : .............................

Form B 


ANNUAL ANALYSIS REPORT FOR 

THE RATE OF DISCREPANCIES OF TREATMENT VERIFICATION IMAGES 

Name of Hospital : .................................................................. 

Year : .................................................................. 

Month 

Jan 

Total number of 

verification images taken 

Total number of 

rejected verification 

images 

*Rate of discrepancies 

(%) 

Feb 

Mac 

Apr 

May 

Jun 

Jul 

Aug 

Sept 

Oct 

Nov 

Dec 

Total 

Total number of rejectedimages 

* The rate of discrepancies (%) 

100% 

Total number of verification 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 

Jadual 2 

Jadual 3 

Jadual 4 

Jadual 4.a 

Jadual 4.b 

Jadual 4.b.i 

: Simulator 

: CT Simulator 

: Irradiating Apparatus below 1 MV 

: Linear Accelerator (LINAC) 

: Additional QC Parameters for LINAC-Based Stereotactic 

Radiosurgery/Radiotherapy (SRS/SRT) 

: Additional QC Parameters for LINAC-Based Intensity 

Modulated Radiation Therapy (IMRT) 

: 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 

Jadual 6 

: Helical Tomotherapy 

: Cyberknife 

Jadual 7 

Jadual 7.a 

Jadual 7.b 

: 

: 

: 

Brachytherapy 

Remote Afterloading Brachytherapy Unit 

Special Procedures for Permanent Interstitial Brachytherapy 

Jadual 8 

Jadual 9 

Jadual 10 

: Treatment Planning System for Teletherapy 

: Imaging Systems (Portal Imaging and Image Guided Radiation 

Therapy) 

: Intraoperative Radiation Therapy (Low kV Photon) 

11


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 


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, 

2 mm diameter 

couch axes and isocentre 

x. Table top sag 2 mm 

xi. Vertical travel of couch 

2 mm 

3. Radiographic and Fluoroscopic Checks 

i. Exposure reproducibility 10% Annually or 

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 

vii. Leakage radiation 


* 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 



Localising lasers 2mm Daily 


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 

ii. Scout localisation image 

±20% of nominal value 

Annually 

4. Scan Localisation 

i. Axial scan localisation light 

accuracy 

ii. Isocentre alignment, sagittal and 

coronal localisation light accuracy 

±2 mm Annually 

±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 (



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 

iii. Noise 

No significant artefacts 

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 Daily 

water remains relatively constant 

ii. CT number calibration Water : 0 ± 5HU Monthly 

iii. Accuracy of distance 

±1 mm Annually 

measurements (transaxial and 

scan localisation images) 

iv. CT number dependence on scan 

± 3HU 

thickness 

v. CT number dependence on 

phantom size 

± 20HU 

vi. CT number dependence on 

phantom position 

vii. CT number dependence on 

reconstruction algorithm 

± 5HU 

± 3HU 

8. Scattered and Leakage Radiation 

i. Scattered radiation



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 


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 



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 

Semi-Annually 

ii. HVL test 

Standard recognised by Semi-Annually 

iii. Beam homogeneity film test 

the appropriate authority 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 

1 mGy per hour at 5 cm 

from the tube housing 

10 mGy per hour at 1 m 

from the source 

Tube head 

change or 

service 

c) 500 kVp - 999 kVp 

0.1 percent of useful 

beam or 10 mGy per 

hour, whichever is greater 

at 1 m from the source 

ii. Applicator geometrical accuracy and 

beam axis indication on rotation 

iii. Dose monitor reproducibility 

iv. Dose monitor linearity 

v. Output consistency 

< 2 mm Quarterly 

< 0.5% 

2% 

3% 

Quarterly 

Quarterly 

Quarterly 

17


Jadual 4: Linear Accelerator 



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% 


i. Light/radiation field coincidence 2 mm for field up to 20 cm or 

± 1% for field over 20 cm 

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 

Monthly 

Safety Checks 

i. Emergency off switches Functional 

ii. Wedge, electron cone interlocks 

Functional 

4. Dosimetry 

i. X-ray/electron output calibration 

constancy 

ii. Photon central axis parameter 

constancy (PDD, TAR) 

2% Annually 

2% 

18



iii. Electron central axis dosimetry 

parameter constancy (PDD) 

2 mm at therapeutic depth 

iv. Field size dependence of x-ray output 

constancy 

v. Output factor constancy for electron 

applicators 

2% 

2% 

vi. X-ray output constancy vs. gantry angle 2% 

vii. Electron output constancy vs. gantry 

2% 

angle 

viii. Wedge transmission factor constancy 2% 

ix. Monitor chamber linearity 1% 

x. Transmission factor constancy for all 

2% 

treatment accessories 

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 2 mm diameter 

axes with isocentre 

v. Coincidence of radiation and 

2 mm diameter 

mechanical isocentre 

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. 

19


Jadual 4.a: Additional QC Parameters for LINAC-Based Stereotactic 

Radiosurgery/Radiotherapy (SRS/SRT) 


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) 

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 

Annually 


i. Coincidence of radiation and 

mechanical isocentre 

ii. Stereotactic accessories, lockouts, 

etc. 

±1 mm from baseline 

Functional 

20


Jadual 4.b: Additional QC Parameters for LINAC-Based 

Intensity Modulated Radiation Therapy (IMRT) 


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% 


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 

1 mm 

2 mm 

1 mm (diameter) 

±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) 

v. X-ray beam quality (PDD 10 or 

vi. 

X-ray monitor unit linearity (output 

constancy) 

2% for field size




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


Jadual 4.b.i: Additional QC Parameters for Multi-leaf Collimation 

(With differentiation of IMRT vs. non-IMRT machines) 


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) 

ii. Travel speed (IMRT for sliding 

window technique) 

iii. Leaf position accuracy (IMRT) 

2 mm Monthly 

Loss of leaf speed > 0.5cm/s 

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 

ii. Leaf position repeatability 

iii. MLC spoke shot 

iv. Coincidence of light field and x-ray 

field (all energies) 

v. Segmental IMRT (step and shoot) 

test 

vi. Moving window IMRT (four cardinal 

gantry angles) 

±0.5% from baseline Annually 

±1.0 mm 

≤1.0 mm radius 

±2.0 mm 


Jadual 4.b.ii: Additional QC Parameters for Dynamic/universal/virtual wedges 


1. Morning check-out run for 

one angle 

Dynamic Universal Virtual 

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 

24


Jadual 5: Helical Tomotherapy 


1. i. Output – rotational or static 3% Daily 

ii. Image/laser coordinate coincidence 

iii. Image registration/alignment 

iv. Red laser initialization 

2 mm for non-SRS/SBRT 

1 mm for SRS/SBRT 

1mm 

1.5 mm for non-SRS/SBRT 



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 

Transverse profile 

Longitudinal profiles (each slice width) 

1% PDD 10 or 

20 

TMR 

10 

1% average difference in field core 

1% of slice width at FWHM 

Alignment and Miscellaneous 

Interrupted procedure 

3% 

(agreement with uninterrupted 

procedure) 

Red laser movement 

1 mm 

Treatment couch 

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 

Noise 

Uniformity 

Spatial resolution 

Contrast 

2 mm for non-SRS/SBRT 


Consistency with baseline 


1.6 mm object 


25



(if MVCT is used for dose calculation) 

Uniformity 

HU (water test plug) 

HU (lung/bone test plug) 

25HU 

within ±HU 30 of baseline 

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



v. Red Movable Lasers Red-green laser overlap ±1 mm 

Red-green laser twist



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 

Measured doses are within 3% or 3 

mm of values predicted by beam 

model 

Annually 

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 4% or 3 

mm of values predicted by beam 

model 

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 

28



iii. Image Artefacts 

iv. Dose 

There are no significant ring, streak, 

and button artefacts in the image 

Dose measured for a Fine 

TomoImage scan


Jadual 6: Cyberknife 


1. i. System status Passed/Failed Daily 

ii. Safety checks 

a) Door interlock (beam off) 

b) Audiovisual monitor 

iii. Collimator assembly collision detector 

iv. Detection of incorrect and missing 

collimator 

Functional 

Functional 

Functional 

Functional 

v. LINAC output constancy check < 2% 

vi. Robot mastering (perch position 

< 1mm 

laser) check 

vii. AQA targeting reproducibility test 

< 1mm from baseline 

2. i. Absolute dose 2% Monthly 

ii. 

X-ray energy 

a. Depth of d max 

b. Percent depth dose at D 10cm (PDD 10 ) 

± 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 ± 0.3 0 

0 ± 0.3 0 

< 5mm from centre 

30



xi. Imaging system bad pixel statistics Bad pixels less than 

maximum limit, number and 

position 

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 

Quarterly 

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% 

31



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 

32


Jadual 7: Brachytherapy 

Jadual 7.a: Remote Afterloading Brachytherapy Unit 


1. i. Room safety door interlocks, lights, and 

alarms 

ii. Console functions, switches, batteries, 

printers 

iii. Visual inspection of source guides 

iv. System self test 

Functional 

Functional 

Free of kinks and 

firmly attached 

Functional 

Each treatment day 

2. i. Source positioning 

ii. Timer function 

1 mm 

1% 

Each treatment day 

or Weekly 

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 


1. Safety and Radiation Protection 

i. Emergency equipment (forceps, tweezers, 

emergency safe, survey meter) 

Available 

ii. Source preparation area survey Performed 

Before the start of 

implant 

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 

Maximum 3% 

Maximum 5% 

Verification 


implant 

iv. 

Grid calibration in ultrasound system 

Performed 


implant or 

Quarterly 

34


Jadual 8: Treatment Planning System for Teletherapy 


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 

2% Annually 

etc for open and irregular fields) 

iv. Beam profiles (including open, wedged and 

2% Annually 

asymmetric beams) 

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 

2% Annually 

open and irregular fields) 

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 

35


Jadual 9: Imaging Systems 

(Portal Imaging and Image Guided Radiation Therapy) 

No. Parameters Tolerance 

Non-SRS/SBRT 

1. Planar kV and MV (EPID) imaging 

Tolerance 

SRS/SBRT 

Frequency 

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 ≤2 mm 

≤1 mm 

coincidence (four cardinal angles) 

ii. Scaling ≤2 mm ≤1 mm 

iii. Spatial resolution Baseline Baseline 

iv. Contrast Baseline Baseline 



i. Geometric distortion ≤2 mm ≤1 mm 

ii. Spatial resolution Baseline Baseline 

iii. Contrast Baseline Baseline 

iv. HU constancy Baseline Baseline 


36


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 




*Baseline means that the measured data are consistent with acceptance testing data. 

37


Jadual 10: Intra-operative Radiation Therapy (Low kV Photon) 


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 

38

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