Act and regulatory requirements hotel selesa 9 jun2012

ACT 304 AND RELATED ACT 304 AND RELATED REGULATORY REGULATORY

REQUIREMENTS IN REQUIREMENTS IN DIAGNOSTIC RADIOLOGYDIAGNOSTIC RADIOLOGY

Muhammad Khalis Bin Abdul KarimRadiation Health and Safety Unit

Johor State Health DepartmentMinistry of Health Malaysia

ContentsContentsContentsContents

BackgroundBackgroundBackgroundBackground

Atomic Energy Licensing Act Atomic Energy Licensing Act 1984 (Act 304)1984 (Act 304)Atomic Energy Licensing Act Atomic Energy Licensing Act 1984 (Act 304)1984 (Act 304)

Regulatory and Licensing Regulatory and Licensing Requirements in Diagnostic Requirements in Diagnostic RadiologyRadiology

Regulatory and Licensing Regulatory and Licensing Requirements in Diagnostic Requirements in Diagnostic RadiologyRadiology

Subsidiary regulations under Subsidiary regulations under Act 304Act 304Subsidiary regulations under Subsidiary regulations under Act 304Act 304

Part IPart IPart IPart I

BackgroundBackground BackgroundBackground

ActAct

RegulationsRegulations

Circulars/ Standards Circulars/ Standards & Code*& Code*

Local Rules, Local Rules, Guidelines, Guidelines, Instructions ManualInstructions Manual

11

22

33

44

Legally Bound

Voluntary

* Not regulatory by itself but becomes regulatory if linked to Regulations/Acts* Not regulatory by itself but becomes regulatory if linked to Regulations/Acts

Legislation HierarchyLegislation Hierarchy

6,570 radas

In the numbers In the numbers (1) (1)

- First legislation regulating the use of First legislation regulating the use of ionising radiation.ionising radiation.

- MOH control the use of ionising radiation MOH control the use of ionising radiation for medical and non-medical for medical and non-medical

Radioactive Substance Act 1968Radioactive Substance Act 1968

Atomic Energy Licensing Act 1984 (Act 304)Atomic Energy Licensing Act 1984 (Act 304)

- Replaces and supersedes Radioactive Replaces and supersedes Radioactive Substance Act 1968.Substance Act 1968.

- Act under MOSTIAct under MOSTI

Malaysian LegislationMalaysian Legislation

• Act 304 was gazetted under the purview of Ministry of Science, Technology and Innovation Malaysia (MOSTI).

• The Director-General of Health The Director-General of Health where the activity to be licensed under this Act is in respect of the use of ionizing radiation for medical purposemedical purpose as determined in Section 15 (2) Act 304.

• RHSS, MOH is entrusted as the secretariat for the D-G of Health, in all activities that related to the use of ionising radiation for medical purposes.

Cont..Cont..

MedicalMedical Non-MedicalNon-Medical

Director General of Health(Regulatory AuthorityRegulatory Authority)

Secretariat: Radiation Health & Safety Section

(RHSS), MoH

Atomic Energy Licensing Board (AELB)(Regulatory AuthorityRegulatory Authority) Atomic Energy Licensing Board (AELB)

(Regulatory AuthorityRegulatory Authority)

Executive Secretary to the Board

Ministry of Science, Tech and Innovation (MOSTI)

Ministry of Health Malaysia

Secretariat :AELB (Dept)

Regulatory AuthorityRegulatory Authority

Atomic Energy Licensing Act 1984 (Act Atomic Energy Licensing Act 1984 (Act 304)304)

Radiation Protection (Radiation Protection (LicensingLicensing) ) Regulations 1986Regulations 1986

Subsidiary RegulationsSubsidiary Regulations

Main ActMain Act

Radiation Protection (Radiation Protection (Basic Safety Basic Safety StandardStandard) Regulations 1988) Regulations 1988

Radiation Protection (Radiation Protection (TransportsTransports) ) Regulations 1989Regulations 1989


Atomic Energy Licensing (Atomic Energy Licensing (Basic Safety Basic Safety Radiation ProtectionRadiation Protection) Regulations 2010) Regulations 2010

Malaysian Standards (MS 838) : Code of Practice Malaysian Standards (MS 838) : Code of Practice For Radiation Protection (Medical X-Ray Diagnosis) For Radiation Protection (Medical X-Ray Diagnosis) - - 19851985 (1(1stst Revision, 2007) Revision, 2007)

Circular on Employment of Trained X-Ray Operators By Private General Practitioners - 1993

Guidelines To Obtain Class C License Under the Guidelines To Obtain Class C License Under the Atomic Energy Licensing Act 1984 - Atomic Energy Licensing Act 1984 - 19941994

Guidelines For Medical Diagnostic Procedures Guidelines For Medical Diagnostic Procedures Using X-ray For Women of Childbearing Potential - Using X-ray For Women of Childbearing Potential - 19981998

Malaysian Standards (MS 838) : Code of Practice Malaysian Standards (MS 838) : Code of Practice For Radiation Protection (Medical X-Ray Diagnosis) For Radiation Protection (Medical X-Ray Diagnosis) - - 19851985 (1(1stst Revision, 2007) Revision, 2007)

Circular on Employment of Trained X-Ray Operators By Private General Practitioners - 1993

Guidelines To Obtain Class C License Under the Guidelines To Obtain Class C License Under the Atomic Energy Licensing Act 1984 - Atomic Energy Licensing Act 1984 - 19941994

Guidelines For Medical Diagnostic Procedures Guidelines For Medical Diagnostic Procedures Using X-ray For Women of Childbearing Potential - Using X-ray For Women of Childbearing Potential - 19981998

Guidelines/CircularsGuidelines/Circulars


Circulars on Licensing Requirements Under Act 304 For Specialized Diagnostic Radiology Services Provided by Private Hospitals/ Radiology Clinics – 1999

Circulars on Licensing Requirements Under Act 304 For Specialised Diagnostic Radiology Services Provided by GP Clinics - 1999

Circulars to TKPK(Medical), TKPK(Public Health) & Pengarah Perancang & Pembangunan – 2001

Guidelines On The Use of Mobile X-ray Machines - Guidelines On The Use of Mobile X-ray Machines - 20052005

Circulars on Licensing Requirements Under Act 304 For Specialized Diagnostic Radiology Services Provided by Private Hospitals/ Radiology Clinics – 1999

Circulars on Licensing Requirements Under Act 304 For Specialised Diagnostic Radiology Services Provided by GP Clinics - 1999

Circulars to TKPK(Medical), TKPK(Public Health) & Pengarah Perancang & Pembangunan – 2001

Guidelines On The Use of Mobile X-ray Machines - Guidelines On The Use of Mobile X-ray Machines - 20052005

Continue..


Part IIPart IIPart IIPart II

Atomic Energy Atomic Energy Licensing Act (Act Licensing Act (Act

304)304)

Atomic Energy Atomic Energy Licensing Act (Act Licensing Act (Act

304)304)

Atomic Energy Licensing Act Atomic Energy Licensing Act

19841984

Atomic Energy Licensing Act Atomic Energy Licensing Act

19841984Atomic Energy Licensing Board, functions, powers

Control and licensing

Cancellation, Suspension and Renewal of Licenses

Health and Safety

Disposal of Radioactive Waste

Power of seizure and Arrest, Offences and Forfeiture

Liability for Nuclear Damage

Atomic Energy Licensing Board, functions, powers

Control and licensing

Cancellation, Suspension and Renewal of Licenses

Health and Safety

Disposal of Radioactive Waste

Power of seizure and Arrest, Offences and Forfeiture

Liability for Nuclear Damage

ContentsContents

Appropriate AuthorityAppropriate AuthorityAppropriate AuthorityAppropriate Authority

a) The Director-General of Director-General of HealthHealth where the activity to be licensed or licensed under this Act is in respect of a medical purpose

a) The Director-General of Director-General of HealthHealth where the activity to be licensed or licensed under this Act is in respect of a medical purpose

b) The BoardBoard where the activity to be licensed or licensed under this Act is in respect of a purpose other than a medical purpose

b) The BoardBoard where the activity to be licensed or licensed under this Act is in respect of a purpose other than a medical purpose

Sec 2 of Atomic Energy Licensing Act 1984

Act 304Act 304Act 304Act 304

Control and licensingControl and licensingControl and licensingControl and licensing

12.(1) Without prejudice to the requirements of any other law, no person shall :

12.(1) Without prejudice to the requirements of any other law, no person shall :

a) site, construct or operate a nuclear installation

a) site, construct or operate a nuclear installation

b) deal in, possess or dispose of any radioactive material, nuclear radioactive material, nuclear material, prescribed substance material, prescribed substance oror irradiating apparatusirradiating apparatus

b) deal in, possess or dispose of any radioactive material, nuclear radioactive material, nuclear material, prescribed substance material, prescribed substance oror irradiating apparatusirradiating apparatus

unless he is the holder of a valid license

unless he is the holder of a valid license


12.(3) A licence for using any any radioactive material, nuclear radioactive material, nuclear material, prescribed substance or material, prescribed substance or irradiatingirradiating apparatus for diagnostic apparatus for diagnostic or therapeutic purposes may be or therapeutic purposes may be issuedissued ONLY ONLY toto a registered a registered medical practitioner, registered medical practitioner, registered veterinary surgeon, radiologist, veterinary surgeon, radiologist, radiotherapist or registered dentistradiotherapist or registered dentist

12.(3) A licence for using any any radioactive material, nuclear radioactive material, nuclear material, prescribed substance or material, prescribed substance or irradiatingirradiating apparatus for diagnostic apparatus for diagnostic or therapeutic purposes may be or therapeutic purposes may be issuedissued ONLY ONLY toto a registered a registered medical practitioner, registered medical practitioner, registered veterinary surgeon, radiologist, veterinary surgeon, radiologist, radiotherapist or registered dentistradiotherapist or registered dentist


17(1) Licenses issued under this Act shall be subjected to such conditions as may, be imposed by the appropriate authority which may in respect of the conditions imposed by it, add to, vary or revoke such conditions at any time.

Condition of LicensesCondition of LicensesCondition of LicensesCondition of Licenses


Cancellation, Suspension and Cancellation, Suspension and Renewal of LicensesRenewal of Licenses

Cancellation, Suspension and Cancellation, Suspension and Renewal of LicensesRenewal of Licenses

22(1) The appropriate authority may at any time under any of the following circumstances in its discretion cancel, or suspend any license ;

a) Where the licensee has committed an offence under this Act

b) Where the licensee has committed a breach of any of the conditions of the license

c) Where the licensee ceases to work or operate the nuclear installation in respect of which the license was issued

d) Where in the opinion of the appropriate authority it would be in the public interest so to do

a) Where the licensee has committed an offence under this Act

b) Where the licensee has committed a breach of any of the conditions of the license

c) Where the licensee ceases to work or operate the nuclear installation in respect of which the license was issued

d) Where in the opinion of the appropriate authority it would be in the public interest so to do


660 radas penyinaran

660 radas penyinaran


279 premis swasta

279 premis swasta


Health and SafetyHealth and SafetyHealth and SafetyHealth and Safety

25 (1) Every licensee shall comply with all such directives as the appropriate authority may issue…, including :

25 (1) Every licensee shall comply with all such directives as the appropriate authority may issue…, including :

a) Conditions of exposure

b) Dose limitation

c) Occupation exposure

d) Medical exposure

e) Exposure of members of the public

f) Accidental exposure

g) Emergency exposure

a) Conditions of exposure

b) Dose limitation

c) Occupation exposure

d) Medical exposure

e) Exposure of members of the public

f) Accidental exposure

g) Emergency exposure


25 (2) If the appropriate authority has reasonable cause to believe that any workers has been or likely to be exposed …, licensee shall :

25 (2) If the appropriate authority has reasonable cause to believe that any workers has been or likely to be exposed …, licensee shall :a) provide and require such worker to

wear approved personnel monitoring personnel monitoring devicesdevices

b) keep records of doserecords of dose and type of ionizing radiation

c) install or use monitoring devicesmonitoring devices in work places to record the amount of ionizing radiation present

d) provide medical examinationmedical examination for such worker

a) provide and require such worker to wear approved personnel monitoring personnel monitoring devicesdevices

b) keep records of doserecords of dose and type of ionizing radiation

c) install or use monitoring devicesmonitoring devices in work places to record the amount of ionizing radiation present

d) provide medical examinationmedical examination for such worker


Disposal of Radioactive WasteDisposal of Radioactive WasteDisposal of Radioactive WasteDisposal of Radioactive Waste

26 (1) No person shall dispose of or cause to be disposed any radioactive waste without the prior authorization in writing of the appropriate authority

26 (1) No person shall dispose of or cause to be disposed any radioactive waste without the prior authorization in writing of the appropriate authority


Powers of Seizure and Arrest, Powers of Seizure and Arrest, Offences and ForfeitureOffences and Forfeiture

Powers of Seizure and Arrest, Powers of Seizure and Arrest, Offences and ForfeitureOffences and Forfeiture

33 (1) & 34 (1) Senior Public Officer authorize to, with or without warrant :

33 (1) & 34 (1) Senior Public Officer authorize to, with or without warrant :

a) Enter the premises, site, nuclear installation or conveyance and there to searchto search and seizeseize such radioactive material, nuclear material, prescribed substance, irradiating apparatus, book or document;

a) Enter the premises, site, nuclear installation or conveyance and there to searchto search and seizeseize such radioactive material, nuclear material, prescribed substance, irradiating apparatus, book or document;

b) ArrestArrest any person being in or on the premises, site, nuclear installation or conveyance in whose possession or under whose control such radioactive material, nuclear material, prescribed substance, irradiating apparatus, book or document is found;

b) ArrestArrest any person being in or on the premises, site, nuclear installation or conveyance in whose possession or under whose control such radioactive material, nuclear material, prescribed substance, irradiating apparatus, book or document is found;


a) Break open any door or window or part of the premises, site, nuclear installation or conveyance and there to have ingress thereinto;

b) Forcibly enter the the premises, site, nuclear installation or conveyance

c) Remove by force any obstruction to entry, search, seizure and removal as he is empowered to effect

a) Break open any door or window or part of the premises, site, nuclear installation or conveyance and there to have ingress thereinto;

b) Forcibly enter the the premises, site, nuclear installation or conveyance

c) Remove by force any obstruction to entry, search, seizure and removal as he is empowered to effect

33(2) Senior Public Officer may if necessary, with or without assistance:-

33(2) Senior Public Officer may if necessary, with or without assistance:-

d) Detain every person found in or on the premises, site, nuclear installation or conveyance until the premises, site, nuclear installation or conveyance has been searched

d) Detain every person found in or on the premises, site, nuclear installation or conveyance until the premises, site, nuclear installation or conveyance has been searched


38(1) Any radioactive material, nuclear material, prescribed substance, irradiating apparatus or radioactive waste in respect of which an offence under this Act is committed, or any book, document or conveyance connected with such offence is liable to forfeitureforfeiture

38(1) Any radioactive material, nuclear material, prescribed substance, irradiating apparatus or radioactive waste in respect of which an offence under this Act is committed, or any book, document or conveyance connected with such offence is liable to forfeitureforfeiture


39 – Specific offences [(a) – (i)] under this Section is, on conviction, liable to imprisonment for a term not exceeding 5 YEARS5 YEARS or a fine not exceeding RM10,000RM10,000 or BOTHBOTH

39 – Specific offences [(a) – (i)] under this Section is, on conviction, liable to imprisonment for a term not exceeding 5 YEARS5 YEARS or a fine not exceeding RM10,000RM10,000 or BOTHBOTH

40(2) Any person who commits an offence under this Act is liable to imprisonment for a term not exceeding 10 YEARS10 YEARS or a fine not exceeding RM100,000RM100,000 or BOTHBOTH

40(2) Any person who commits an offence under this Act is liable to imprisonment for a term not exceeding 10 YEARS10 YEARS or a fine not exceeding RM100,000RM100,000 or BOTHBOTH

OffencesOffencesOffencesOffences


Part IIIPart IIIPart IIIPart III

Subsidiary Subsidiary Regulations under Act Regulations under Act

304 304

Subsidiary Subsidiary Regulations under Act Regulations under Act

304 304 Radiation Protection (Radiation Protection (LicensingLicensing) ) Regulations 1986Regulations 1986

Atomic Energy Licensing (Atomic Energy Licensing (Basic Basic Safety Radiation Protection)Safety Radiation Protection) Regulations 2010 Regulations 2010 Draft Radiation Protection (Draft Radiation Protection (Medical, Medical, Dental and Veterinary Usage of Dental and Veterinary Usage of RadiationRadiation) Regulations 201__ ) Regulations 201__

- Review fees and application forms – one form for all type of application, etc

– still in JKK of LPTA

Classification of licenses General Conditions for Obtaining a

License Application for, Amendment and

Renewal of License License fees

Classification of licenses General Conditions for Obtaining a

License Application for, Amendment and

Renewal of License License fees



ContentsContents

Classification of LicensesClassification of LicensesClassification of LicensesClassification of Licenses

Class AClass AA license to manufacture, trade in, produce, process, purchase, own, possess, use, transfer, handle, sell or store radioactive materialradioactive material

Class Class BB

A license to manufacture, trade in, ..… or store nuclear materialnuclear material

Class CClass C A license to manufacture, trade in, ….. or store irradiating apparatusirradiating apparatus

Class Class DD

A license to transporttransport radioactive material, nuclear material, prescribed substances or their waste

Class Class EE

A license to export or importexport or import radioactive material, nuclear material, prescribed substances, irradiating apparatus or their waste

Class Class FF

A license to site, to construct or to operate a a nuclear installation nuclear installation

Class Class GG

A license to

i)i) disposedispose of radioactive material, nuclear materials, prescribed substances or their wastes

ii)ii) storestore of radioactive material, nuclear materials, prescribed substances or their wastes prior to their disposalprior to their disposal

iii)iii) DecommissionDecommission a milling installation, nuclear installation, waste treatment facility, irradiating apparatus or sealed sources apparatus

Class Class HH

A license to control of activities not coveredcontrol of activities not covered by classes A to G

Cont..Cont..

General Conditions For General Conditions For Obtaining a LicensesObtaining a Licenses

General Conditions For General Conditions For Obtaining a LicensesObtaining a Licenses

12 (a) The applicant shall employ a person or employ a person or persons having the necessary knowledge, persons having the necessary knowledge, skill and trainingskill and training to ensure that the activities sought to be licensed are carried out in such manner as to protect the health of workers and members of the public

(b) The applicant’s proposed equipment, proposed equipment, facilities and procedures shall be facilities and procedures shall be adequate adequate to protect the health of workers and member of the public and to minimize danger to life, property and the environment

12 (a) The applicant shall employ a person or employ a person or persons having the necessary knowledge, persons having the necessary knowledge, skill and trainingskill and training to ensure that the activities sought to be licensed are carried out in such manner as to protect the health of workers and members of the public

(b) The applicant’s proposed equipment, proposed equipment, facilities and procedures shall be facilities and procedures shall be adequate adequate to protect the health of workers and member of the public and to minimize danger to life, property and the environment

Category/Type of Irradiating Apparatus

License fee per year in RM

1 Dental X-ray units, mobile & fixed medical x-ray units, mobile veterinary X-ray units

RM100 for the first apparatus

RM20 for every additional apparatus

2X-ray therapy units not operable above 500kVp



3CT Scanner units, Accelerators, X-ray therapy units operable above 500kVp



Application Fee RM15

License & Application License & Application FeesFees

Reg 15 of Rad. Protec (Licensing) Regulations 1986

Category of Sealed Source License fee per year in RM

1

Any sealed source with activity not greater than 40MBq

RM100 for the first source

RM20 for every additional source

2

Radiation gauges and other sealed sources not specified in this Schedule



3

Medical therapy sources with activity not greater than 400MBq, etc



4

Medical therapy sources with activity greater than 400MBq, irradiation cell for

sterilization purposes, etc



Reg 15 of Rad. Protec (Licensing) Regulations 1986

Cont..Cont..

21 CT Scan21

CT Scan


15 February 2010

Atomic Energy Licensing Atomic Energy Licensing (Basic (Basic Safety Radiation Protection) Safety Radiation Protection)

Regulations 2010Regulations 2010

Atomic Energy Licensing Atomic Energy Licensing (Basic (Basic Safety Radiation Protection) Safety Radiation Protection)

Regulations 2010Regulations 2010

NEWNEW

Atomic Energy Atomic Energy LicensingLicensing ( (Basic Basic Safety Radiation Safety Radiation

ProtectionProtection) ) Regulations 2010Regulations 2010

NEWNEW

Atomic Energy Atomic Energy LicensingLicensing ( (Basic Basic Safety Radiation Safety Radiation

ProtectionProtection) ) Regulations 2010Regulations 2010

OLDOLD

Radiation Radiation ProtectionProtection ( (Basic Basic Safety StandardSafety Standard) ) Regulations 1988Regulations 1988

OLDOLD

Radiation Radiation ProtectionProtection ( (Basic Basic Safety StandardSafety Standard) ) Regulations 1988Regulations 1988

VSVS

Based on ICRP 60, 1990

80 provisions

More provisions on Medical Exposure – 18 provisions

Based on ICRP 26, 1977

56 provisions

Medical Exposure – 5 provisions

“medical exposuremedical exposure” means the exposure incurred by :

(b) (b) a person who knowingly assists in the a person who knowingly assists in the support and comfort of patients, other than support and comfort of patients, other than a person who is occupationally exposed; ora person who is occupationally exposed; or

(c) (c) a volunteer in a medical research a volunteer in a medical research programme that involves radiation programme that involves radiation exposure;exposure;

(a) (a) a patient as part of his medical or dental a patient as part of his medical or dental investigative or diagnostic procedures or investigative or diagnostic procedures or treatment;treatment;

Reg. 3

InterpretationInterpretation

Atomic Energy Licensing (Basic Safety Radiation Atomic Energy Licensing (Basic Safety Radiation Protection) Regulations 2010Protection) Regulations 2010

PART I - PRELIMINARY

ARRANGEMENT OF REGULATIONSARRANGEMENT OF REGULATIONS

PART II - SYSTEM OF RADIATION PROTECTION

PART III - OCCUPATIONAL EXPOSURE

PART IV - MEDICAL EXPOSURE

Specific provisions in diagnostic radiology

• Requirements for irradiating apparatus and equipment using sealed sources for diagnostic radiology

• Operational consideration for diagnostic exposure• Clinical dosimetry• Quality assurance for medical exposure• Guidance levels

• Investigation, notification and reporting of accidental medical exposure

Cont..Cont..Cont..Cont..

ARRANGEMENT OF REGULATIONSARRANGEMENT OF REGULATIONS

PART VIII - SUBMISSION OF DOCUMENTS

PART IX - CESSATION OF OPERATIONS, DECOMMISSIONING OR ABANDONMENT OF LICENSED FACILITIES

PART X - GENERAL

PART VI - POTENTIAL EXPOSURE AND SAFETY OF RADIATION SOURCES

PART VII - INTERVENTION

PART V - PUBLIC EXPOSURE

“clean areaclean area” - an area where the annual dose received by a workeris not likely to exceed the dose limit for a member of the public;

“controlled areacontrolled area” - area in which specific protection measures andsafety provisions are required for controlling normal exposures or preventing the spread of contamination during normal working conditions, and preventing or limiting the extent of potential exposures;

“supervised areasupervised area” - an area for which occupational exposure conditions are kept under review even though specific protective measures and safety provisions are not normally needed;

Classification of Working Areas :

Working AreaWorking Area

Clean Areas, Supervised Areas Clean Areas, Supervised Areas and Controlled Areasand Controlled Areas

PART I - PRELIMINARY

Reg. 3

PART III - OCCUPATIONAL EXPOSURE

Supervised AreasSupervised Areas and Controlled Controlled AreasAreas have to clearly demarcated and appropriate legible notices and warning signs bearing the radiation symbol are posted conspicuously in strategic places.

Classification of Working Classification of Working AreaArea

Question Question

Where is the area considered as Where is the area considered as controlled area in a diagnostic controlled area in a diagnostic imaging department ??imaging department ??

Where is the area considered as Where is the area considered as controlled area in a diagnostic controlled area in a diagnostic imaging department ??imaging department ??

Whole Body ExposureDose Limit (mSv/year)

Public

Radiation Workers

Foetus

BSS 19881

50

10

BSS 20101

20*

1

PART II - SYSTEM OF RADIATION PROTECTION

Dose Limit for Workers & Dose Limit for Workers & Member of PublicMember of Public

* The maximum effective dose on the worker averaged over a * The maximum effective dose on the worker averaged over a period of 5 consecutive years shall not exceed 20mSvperiod of 5 consecutive years shall not exceed 20mSv

Reg. 8 & 9

Question Question

What is the patient dose limit ?

A : 1 mSv/year

B : 20 mSv/year

C : 50 mSv/year

ANS: NO LIMIT

Public

Radiation workers (new BSS

Regulations – 2010)

Radiation workers (old BSS

Regulations 1988)

D : 150 mSv/year

Lens of the eyes

(3) Personnel monitoring shall not be requiredPersonnel monitoring shall not be required for any worker who normally works in a supervised areasupervised area, or who enters a controlled area only occasionally, but the occupational exposure of the worker shall be assessed on the basis of the results of work place monitoring

(2) The licensee shall carry out personnel monitoring for all workers who normally work in a controlled area, and workers who occasionally work in a controlled area but may receive significant occupational exposure.

Personnel MonitoringPersonnel Monitoring

Reg. 22

(1) The licensee shall be responsible for arranging the assessment of the occupational exposure of workers

(a) no patient is administeredno patient is administered with a diagnostic or therapeutic medical exposure unless the exposure is prescribed by an approved registered medical practitioner;

(b) an approved registered medical practitioner is medical practitioner is assigned with the primary task and obligationassigned with the primary task and obligation of ensuring overall patient protection and safety in the prescription of, and during the delivery of, diagnostic or therapeutic medical exposure to the patient;

Responsibilities of licensee or Responsibilities of licensee or employeremployer

PART IV - MEDICAL EXPOSURE

Reg. 41

To ensure that :

(c) an appropriate healthcare professional who is an appropriate healthcare professional who is adequately trainedadequately trained to discharge assigned tasks to the patients in the conduct of the diagnostic or therapeutic procedures that the approved registered medical practitioner prescribes, is available;

(d) for diagnostic uses of radiation, the quality the quality assurance programmeassurance programme specified by the appropriate authority is conducted by or under the supervision of a qualified expert in medical physics;

Cont…Cont…

(a) the exposure of patients is at the minimum level exposure of patients is at the minimum level requiredrequired in order to achieve the intended diagnostic objective;

(b) the relevant information from previous examinationsrelevant information from previous examinations is taken into account in order to avoid unnecessary additional examinations; and

(c) the relevant guidance levelsrelevant guidance levels as specified in the Sixth Schedule is taken into account.

Operational consideration for Operational consideration for diagnostic exposurediagnostic exposure

Reg. 48

(1) For diagnostic radiology practices, the licensee shall ensure:

the diagnostic procedure chosen to produce the to produce the minimum exposure to patient is consistent with the minimum exposure to patient is consistent with the acceptable image qualityacceptable image quality and the clinical purpose of the examination.

Cont…Cont…

the portable and mobile radiological equipment is used the portable and mobile radiological equipment is used only for examinations where it is impracticalonly for examinations where it is impractical or not medically acceptable to transfer patients to a stationary radiological installation, and only after proper attention has been given to the radiation protection measures that are required in its use.

The licensee shall ensure that …The licensee shall ensure that …

any radiological examination causing exposure to the any radiological examination causing exposure to the abdomen or pelvis of women who are pregnant or abdomen or pelvis of women who are pregnant or suspected to be pregnant is avoidedsuspected to be pregnant is avoided, unless there are strong clinical indications for such examinations.

any diagnostic examination of the abdomen or pelvis of any diagnostic examination of the abdomen or pelvis of women of reproductive age is plannedwomen of reproductive age is planned to deliver the minimum dose to the ovary or to any embryo or foetus that might be present.

whenever feasible and appropriate, shielding of shielding of radiosensitive organs such as gonads, lens of the eye radiosensitive organs such as gonads, lens of the eye and thyroid is providedand thyroid is provided.

Cont…Cont…

The licensee shall ensure that …The licensee shall ensure that …

For clinical dosimetry, the licensee shall ensure that the following items are determineddetermined and documenteddocumented:

(a) in radiological examinations, the representative values for typical sized adult patients of entrance surface doses, dose-area entrance surface doses, dose-area products, dose ratesproducts, dose rates and exposure timesexposure times, or organ dosesorgan doses;

Clinical dosimetryClinical dosimetry

52. (1)(a)

53. (1) The licensee shall establish a comprehensive QAP for medical exposure with the participation of appropriate qualified experts in the relevant fields as specified by the appropriate authority.

Quality assurance for medical Quality assurance for medical exposureexposure

(a) the measurement of the physical parameters of the irradiating apparatus, imaging devices and irradiation installations at the time of commissioning and periodically after the commissioning;

(b) verification of the appropriate physical and clinical factors used in patient diagnosis or treatment;

(c) written records of relevant procedures and results;

(d) verification of the appropriate calibration and conditions of operation of dosimetry and monitoring equipment

(2) The quality assurance programmes for medical exposure shall include:

(a) corrective action is taken as necessary if doses or activities fall substantially below the guidance levels and the exposures do not provide useful diagnostic information and do not yield the expected medical benefit to patients; and

(b) review is considered if doses or activities exceed the guidance levels as an input to ensuring optimized protection of patients and maintaining appropriate levels of good practice.

Guidance levels for Medical Guidance levels for Medical ExposureExposure

Reg. 54 (1)

• As a guide by approved registered medical practitioners, in order that :

Tables I of the Sixth Schedule Tables I of the Sixth Schedule

Guidance levels of dose for diagnostic radiography for a typical adult patient

Examination Projection ESD per radiograph * (mGy)

Lumbar spine AP 10LAT 30LSJ 40

Abdomen, intravenous, urography AP 10and cholecystographyPelvis AP 10Hip joint AP 10Chest PA 0.4

LAT 1.5Thoracic spine AP 7

LAT 20Dental Periapical 7

AP 5Skull PA 5

LAT 3In air with back-scatter. These values are for conventional film screen combination in the relative speed of 200. For high speed film screen combinations (400-600), the values should be reduced by a factor of 2 to 3.

GUIDANCE LEVELS FOR DIAGNOSTIC RADIOLOGICAL PROCEDURES

Dose guidance levels for computed tomography for a typical adult patient

Tables II of the Sixth Schedule Tables II of the Sixth Schedule

Examination Multiple scan average dose(mGy)

Head 50

Lumbar spine 35

Abdomen 25

Reference levels

CTDIw (mGy) DLP (mGycm)

Adults (typical value)

Chest 30 650

Chest high resolution 35 280

Abdomen 35 780

Pelvis 35 570

Head 60 1050

Children age <15y (typical value)

Chest 30 600

Chest high resolution 50 100

Abdomen 30 800

Pelvis 30 500

Head 70 750

European Guidance Levels for Computed European Guidance Levels for Computed Tomography for a Typical Adult Patient and ChildrenTomography for a Typical Adult Patient and Children

(1) The licensee shall notify the appropriate (1) The licensee shall notify the appropriate authority of all accidental medical authority of all accidental medical exposures within exposures within 24 hours24 hours after the after the occurrence of such accidental medical occurrence of such accidental medical exposures.exposures.

Investigation, notification and Investigation, notification and reporting of accidental medical reporting of accidental medical exposureexposure

Reg. 57 (1)

(c) (c) any equipment failure, accident, error, mishap any equipment failure, accident, error, mishap or other unusual occurrenceor other unusual occurrence with the potential with the potential for causing a patient exposure significantly for causing a patient exposure significantly different from that which is intended.different from that which is intended.

(2) The licensee shall immediately investigate (2) The licensee shall immediately investigate the following accidental medical exposures:the following accidental medical exposures:

(b) (b) diagnostic exposure substantially greater diagnostic exposure substantially greater than intendedthan intended or resulting in doses or resulting in doses repeatedly and substantially exceeding the repeatedly and substantially exceeding the established guidance level as specified in established guidance level as specified in the Sixth Schedule;the Sixth Schedule;

Reg. 57 (2)

Cont…Cont…

(a) calculate or estimate the doses receivedcalculate or estimate the doses received and their distribution within the patient;

(b) indicate the corrective measures requiredindicate the corrective measures required to prevent recurrence of such an incident;

(c) implement all the corrective measuresimplement all the corrective measures that are under his responsibility;

(d) submit a written reportsubmit a written report within 30 days after the completion of the investigation stating the cause of the accidental medical exposure to the appropriate to the appropriate authorityauthority, and

(e) inform the patient and the approved registered medical inform the patient and the approved registered medical practitionerpractitioner about the incident.

(3) The licensee shall, with respect to any (3) The licensee shall, with respect to any investigation carried out under subregulation (2) investigation carried out under subregulation (2)

Cont…Cont…

58. (1) The licensee shall keep for a period as 58. (1) The licensee shall keep for a period as may be specified by the appropriate authority may be specified by the appropriate authority and make available, when required, the and make available, when required, the following records:following records:

RecordsRecords

(a) (a) in diagnostic radiology, necessary in diagnostic radiology, necessary information to allow retrospective dose information to allow retrospective dose assessment, including the number of assessment, including the number of exposures and the duration of fluoroscopic exposures and the duration of fluoroscopic examinations;examinations;

The licensee shall make suitable arrangements to prevent any accident that could reasonably be foreseen for any radiation source and to limit the consequences of any accident that occurs.

(a) adequate procedures are establishedadequate procedures are established for the control of the radiation source and of any potential accident that is reasonably foreseeable;

(b) the system, components and equipment which are important for the system, components and equipment which are important for safety are inspected and testedsafety are inspected and tested for any degradation that could lead to abnormal conditions or inadequate performance;

(c) appropriate maintenance, inspection and testing are carried outappropriate maintenance, inspection and testing are carried out without undue occupational exposure;

(d) appropriate automatic systems for safely shutting off or reducing appropriate automatic systems for safely shutting off or reducing radiation outputradiation output from the radiation source when the operating conditions exceed the operating ranges are provided; and

(e) provide a system which can detect and respond immediately to a system which can detect and respond immediately to abnormal operating conditionsabnormal operating conditions that can significantly affect the protection or safety and to allow for timely corrective action to be taken, is provided.

Prevention of accidentsPrevention of accidents

Reg. 67

Notification of theft, loss or Notification of theft, loss or sabotagesabotage

(a) notify the appropriate authority of such theft, loss or sabotage within 24 hours24 hours after discovering the theft, loss or sabotage; and

(b) submit a complete report of the theft, loss or sabotage in writing within 30 days30 days after the notification to the appropriate authority.

71. (1)

The licensee shall, upon discovering any theft, loss or The licensee shall, upon discovering any theft, loss or sabotage of any radiation source in his possession or sabotage of any radiation source in his possession or under his control :under his control :

The report shall contain :(a) where appropriate, a description of the radiation source, including

its kind, quantity and its chemical and physical forms;(b) a description of the circumstances under which the theft, loss or

sabotage occurred;(c) a statement of the location or probable location of the radiation

source;(d) the possible radiation exposure to individuals, circumstances under

which the exposures may occur, and the extent of potential hazard to members of the public;

(e) the actions which have been taken, or will be taken, to recover the radiation source;

(f) the procedures or measures which have been or will be adopted to prevent a recurrence of the theft, loss or sabotage of the radiation source; and

(g) any other information as the licensee deems necessary.

Notification of theft, loss or sabotage… Notification of theft, loss or sabotage… contcont

(a) a report on area monitoring;

(b) a report on environmental monitoring;

(c) a report on radioactive discharge;

(d) a report on personnel monitoring;

(e) a report on accidental exposures and emergency exposures;

(f) a report by approved registered medical practitioners;

(g) operational procedures, instructions and manuals;

(h) emergency plans and procedures;

(i) training programmes;

(j) physical protection measures; and

(k) other reports and records as the appropriate authority deems necessary.

(a) a report on area monitoring;

(b) a report on environmental monitoring;

(c) a report on radioactive discharge;

(d) a report on personnel monitoring;

(e) a report on accidental exposures and emergency exposures;

(f) a report by approved registered medical practitioners;

(g) operational procedures, instructions and manuals;

(h) emergency plans and procedures;

(i) training programmes;

(j) physical protection measures; and

(k) other reports and records as the appropriate authority deems necessary.

The appropriate authority may require the licensee to submit any or The appropriate authority may require the licensee to submit any or all of the followings:all of the followings:

Reg. 77

Submission of DocumentsSubmission of Documents

PART X - GENERAL

Transitional provisionsTransitional provisions

A person who holds a licence issued under the Act in relation to activities involving ionizing radiation that is still in force at the date of commencement of these Regulations shall, within 2 years2 years from the date of commencement, comply with the requirements under these Regulations.

Reg. 79

- the draft regulations for medical usage were prepared with IAEA technical assistance

- Approved by Radiological Advisory Committee (RAC)

- To be reviewed & discussed in JKK of MoH

- More comprehensive regulation to control the use of ionizing radiation in medicine under the purview of MoH

Draft Radiation Protection Draft Radiation Protection ((Medical, dental and veterinary Medical, dental and veterinary Usage of RadiationUsage of Radiation) Regulations ) Regulations

20__20__

Draft Radiation Protection Draft Radiation Protection ((Medical, dental and veterinary Medical, dental and veterinary Usage of RadiationUsage of Radiation) Regulations ) Regulations

20__20__

ContentsContentsContentsContentsEstablishment of Radiation Protection Programme

Radiation Protection Committee

Role of Radiation Protection Officer

Implementation of Quality Assurance Programme (QAP)

Radiation Protection Survey

Notification, Reports and Records of Reportable Events

Additional requirements for general radiography, fluoroscopy, CT, mammography, dental radiology & veterinary (RADIOLOGY)

Additional requirements for Radiotherapy

Additional requirements for Nuclear Medicine

Establishment of Radiation Protection Programme

Radiation Protection Committee

Role of Radiation Protection Officer

Implementation of Quality Assurance Programme (QAP)

Radiation Protection Survey

Notification, Reports and Records of Reportable Events

Additional requirements for general radiography, fluoroscopy, CT, mammography, dental radiology & veterinary (RADIOLOGY)

Additional requirements for Radiotherapy

Additional requirements for Nuclear Medicine

Cont..Cont..

238 radiografi am

238 radiografi am


Regulatory & Licensing Regulatory & Licensing Requirements in Diagnostic Requirements in Diagnostic

RadiologyRadiology

Regulatory & Licensing Regulatory & Licensing Requirements in Diagnostic Requirements in Diagnostic

RadiologyRadiology

Part IVPart IVPart IVPart IV

Only Trained Personnel (GP’s Clinic) – 1.1.2000At least 1 qualified radiographer – 1.1.2000

(Private Hosp)Training of New Applicants – 1.1.2000Implementation of QAP: - QC of Equipment, Processor – 1.1.2000

& Associated Facilities - CME Annually –

1.1.2002 - Film Reject Analysis –

1.1.2002 - Audit of X-Ray Radiographs –

1.1.2002 (GP Clinic only)

Only Trained Personnel (GP’s Clinic) – 1.1.2000At least 1 qualified radiographer – 1.1.2000

(Private Hosp)Training of New Applicants – 1.1.2000Implementation of QAP: - QC of Equipment, Processor – 1.1.2000

& Associated Facilities - CME Annually –

1.1.2002 - Film Reject Analysis –

1.1.2002 - Audit of X-Ray Radiographs –

1.1.2002 (GP Clinic only)

Requirements Effective date

Circular to Private Hospital/GP’s Circular to Private Hospital/GP’s Clinics Issued on 21 Oct 1999Clinics Issued on 21 Oct 1999

All plans for facilities under Act 304 to be submitted and approved by Radiation Health and Safety Branch, Engineering Services Division before commencement of installation/renovation

Circular to TKPK (Medical) and Circular to TKPK (Medical) and TKPK (Public Health) – 15.1.2001TKPK (Public Health) – 15.1.2001

All related equipment and facilities to be tested, commissioned and verified to conform to safety and performance standards before clinical use

Implementation of QAPImplementation of QAP• Quality control (QC) of

equipment, processors and associated facilities

• Monitoring and analysis of film reject rate

• Continuous Professional Education (CME)

Cont… Cont…

Procedures To Apply For A License Procedures To Apply For A License (Private) or Getting Approval (Private) or Getting Approval

(Public)(Public)

STEP 1STEP 1

STEP 2STEP 2

Requirements to USEUSE Irradiating Apparatus

Requirements to BUY & BUY & STORSTOR Irradiating Apparatus

Documents required to apply for BUY & STORE Documents required to apply for BUY & STORE Irradiating ApparatusIrradiating Apparatus

Application/Licence fee (private)

Copy of current APC

Layout plan of the premisesDetailed plan of the room where the apparatus will be located

The address of practice stated in APC shall be the same as the address of where apparatus is to be stored or used

Step 1Step 1

Application form (private) or letter of intent (public)

Description of irradiating apparatus

FACILITIES

Layout plan of premises

FACILITIES

Layout plan of premises

Layout plan of premises shall indicate

- Location of the x-ray room, darkroom & occupied area in the premise

Note:

No licence will be issued for X-ray practice in free standing laboratory where there is no doctor practicing in the premise

- All plan shall be in technical drawings & the scale shall be in metric (S.I) unit

i. Dimension of the x-ray room

ii. Material used and thickness of the wall, ceiling and floor

iii. Position, size & material used for the windows, doors and other openings

iv. Position of the apparatus in the x-ray room

v. Position of the operating console/control area

vi. Warning light/sign at the door of the room

Detailed Plan of X-ray room shall clearly specify the following :

FACILITIES Detailed Plan of X-ray Room & Dark Room

FACILITIES Detailed Plan of X-ray Room & Dark Room

Type of EquipmentPlan Spec.

General X-Ray *

Fluoroscopy

Dimension of the room 3.0 m x 4.0m 6.0 m x 4.0m

Thickness of Shielding at the Doors and Walls

2.0mm Pb eq 2.0mm Pb eq

Dimension & Thickness of Lead at the Chest Wall

1.2m x 1.2m x 2.0mm Pb eq

1.2m x 1.2m x 2.0mm Pb eq

Dimension & Thickness of Lead Glass Observation Window

35cm x 30cm x 2.0mm Pb eq

100cm x 50cm x 2.0mm Pb eq

Dimension & Thickness of Lead at the Floor (upper floor)

1.2m x 2.5mx 2.0mm Pb

1.2m x 2.5mx 2.0mm Pb

* Control panel outside with examination tableCont….

X-RAY ROOM- Layout and

Dimension

X-RAY ROOM- Layout and

Dimension

Type of EquipmentPlan Spec

Mammography

CT Scanner

Dimension of the room 2.5 m x 3.0m 5.5 m x 4.0m

Thickness of Shielding at the Doors and Walls

1.0mm Pb eq 2.0mm Pb eq

Dimension & Thickness of Lead at the Chest Wall

NA NA

Dimension & Thickness of Lead Glass Observation Window

NA 100cm x 50cm x 2.0mm

Pb eq

Dimension & Thickness of Lead at the Floor (upper floor)

NA 1.2m x 2.5mx 2.0mm

Cont….NA - Not applicable

X-RAY ROOM- Layout and Dimension X-RAY ROOM- Layout and Dimension

Cont….

- All entrances to x-ray rooms shall be marked with a warning sign

- Consist of a three-blade design using the radiation caution colours, that is black for the design and yellow for the background.

R is the radius of the inner circle and 5R is not less than 7.5 cm

5 R

1.5 R

R

MS 838:1985

X-RAY ROOM- Warning Signs X-RAY ROOM- Warning Signs

Which one is correct ?

New Symbol launched to warn public about radiation dangers - supplementary symbol aims to help reduce needless deaths and injuries, IAEA – 15 February 2007

New Radiation Symbol ????

Cont….

All entrances to x-ray rooms shall have a light that is illuminated prior to exposure or when fluoroscopy is in progress

The warning light should be red in colour (yellow or amber may also be used)MS 838:1985

X-RAY ROOM- Warning Light X-RAY ROOM- Warning Light

Minimum Dimension of = 1.5m x 2.0m Darkroom

Location of darkroom shall not be in the direction of the useful beam.

DARKROOM- Dimension &

Location

DARKROOM- Dimension &

Location

MS838:2007

Step 2Step 2

• Personnel & Training

• Personnel & Training

• Facility• Facility

• Equipment• Equipment

• Procedures• Procedures

Licensee/Org Yg Bertanggungjawab

Supervisor

RPO

Operators

Licensee/Org Yg Bertanggungjawab

Supervisor

RPO

Operators

Requirements to Requirements to STORE & USESTORE & USE Irradiating Irradiating ApparatusApparatus

X-ray Room

Dark room

X-ray Room

Dark room

X-ray Machine

Processor/cassette/Viewer, etc

X-ray Machine

Processor/cassette/Viewer, etc

Local rules, etcLocal rules, etc


Licensee/Org Yg Bertanggungjawab :

Registered Medical Doctor

Registered Med. Doc/Pengarah@ Radiologist

GP clinics/Non X-ray Sp. Clinics/Health Clinics

Hospital/Radiological Clinic

undergo 40 credit hours training program (new applicant)

Attend continuous professional education (CME) program

Supervisor :

Attend yearly continuous professional education (CME) program

GP clinics/Non X-ray Sp. Clinics/Health Clinics


Registered Medical Doctor

Radiologist



Radiation Protection Officer (RPO) :


GP clinic/Non X-ray Specialist Clinic


Registered Medical Doctor or radiographer

Med. Physicist/Radiologist/radiographer



X-ray Operator :

undergo 50 credit hours training program (new operator);

Attend continuous professional education (CME) program yearly

Having a personnel monitoring devices do a medical surveillance once in 3 years

GP clinic/Non X-ray Sp. Clinic


Doctors applying for new licences and newly employed operators are required to undergo the following courses before they are permitted to use the x-ray equipmentMod. 1: Radiation Safety Awareness 9 cr. hrs

Mod. 2: X-ray Equipment and Associated 10 cr. hrs

facilities

Mod. 3: Clinical Practices 31 cr. hrs

Mod. 4: Radiographic Techniques and QAP 21 cr. hrs

TOTAL : (Module 1, 2 & 3 – for operators) 50 cr. hrs

(Module 1, 2 & 4 – for doctors) 40 cr. hrs

Training Syllabus For New Training Syllabus For New Licensees & New OperatorsLicensees & New Operators

Training Syllabus For New Training Syllabus For New Licensees & New OperatorsLicensees & New Operators

1. X-ray operators currently employed in the clinics and have been trained in the Orientation Programme conducted by the College of General Practitioners X-Ray Society of Malaysia or ANM

2. Workers trained in programme approved by the Licensing Authority – the training syllabus and facilities would be vetted before approval is given

3. Medical practitioners

1. X-ray operators currently employed in the clinics and have been trained in the Orientation Programme conducted by the College of General Practitioners X-Ray Society of Malaysia or ANM

2. Workers trained in programme approved by the Licensing Authority – the training syllabus and facilities would be vetted before approval is given

3. Medical practitioners* Subjected to do chest & extremities only

Existing X-ray Existing X-ray OperatorOperator**

Existing X-ray Existing X-ray OperatorOperator**

Employment of at Least 1 RadiographerMammography procedures shall be performed by a qualified female radiographer trained in mammography

Attend continuous professional education (CME) program yearly

Having a personnel monitoring devices Do a medical surveillance once in 3 years

Hospital/Radiology clinic


Medical Medical SurveillanceSurveillance

Medical Medical SurveillanceSurveillance

(Buku LPTA/BM/5)

(Buku LPTA/BM/5)

Do you require to do chest x-ray for medical check-up every time?

Do you require to do chest x-ray for medical check-up every time?

Question:Question:Question:Question:Nota: Pemeriksaan x-ray dada hanya perlu dibuat utk jangkamasa lima (5) tahun sekali; atau apabila difikirkan perlu oleh pengamal perubatan berdaftar yang diluluskan.

Nota: Pemeriksaan x-ray dada hanya perlu dibuat utk jangkamasa lima (5) tahun sekali; atau apabila difikirkan perlu oleh pengamal perubatan berdaftar yang diluluskan.

All personnel/operators (include licensees) are required to attend CME programme to update their knowledge in order to keep abreast of the current practices in radiology annually.

CME All personnel CME All personnel

The training programme may include one of the following :• Radiation protection pertaining to the use of x-

ray equipment• Radiographic techniques• Image quality criteria and requirements• X-ray reporting• Management of QAP• Film processing• Update in radiology

imaging

The above may be achieved :

By attending courses organized by other agencies/ organizations/ societies/ ect

Peer reviewed educational programmes/ distance learning programmes available either on the internet or through posts

CMEAll personnel

CMEAll personnel

Tested & certified by consultant medical physicist approved by MoH – Class H (certification)

Submit certificate with summary report and full report to MoH

QC of Equipment and Associated Facilities:QC of Equipment and Associated Facilities:

FACILITIES & X-RAY EQUIPMENT

Safety and Performance Standard



Facility/ Equipment

Parameter Optimum Achievable Std

Irradiating Apparatus

Machine performance parameter

As specified in the Standard

X-Ray RoomScattered Radiation

Exp. rate at every occupied outside the x-ray room and at the position normally occupied by the operator at the control area shall not exceed 10mR in one week

Dark RoomCondition of the dark room

No light leakage

CassettesCondition of all the cassettes

No light leakage Film and screen should be in good contact





A report of monitoring and analysis of film reject rate shall be submitted every year. It should include the following:i. Monitoring Periodii. No. of film used

iii. No. of film rejected and percentage

iv. Corrective action taken when reject rate > 10%

ADDITIONAL REQUIREMENTS

Monitoring & analysis of film reject rate

ADDITIONAL REQUIREMENTS

Monitoring & analysis of film reject rate

Monitoring and Analysis of Film Reject RateMonitoring and Analysis of Film Reject Rate

10 x-ray radiographs selected randomly from GP’s clinics will be audited by radiologist based on established criteria and standard under circular issued on 21-10-1999.

For each radiograph a minimum score of 7 is required to pass the audit. At least, 7 out of 10 films audited should meet the minimum score of 7 before they are considered to have pass the overall audit

i) Film Audit by Radiologist

ADDITIONAL REQUIREMENTSAudit of X-Ray Radiographs


Audit of X-ray Radiographs*

* For GP’s Clinic/Sp. Clinic only

ii) Letter from Fomema (for Fomema panel’s clinics)

Letter from Fomema to confirm that clinics are participating regularly in the X-ray Quality Control Programme of Fomema and x-ray films taken are satisfactory and adhere to the SOP



Question Question

Does ‘radiation leave’ cover Does ‘radiation leave’ cover under Act 304 or subsidiary under Act 304 or subsidiary regulations ? regulations ?

Answer

NO

Perintah Am Bab C – 47 Cuti tugas khas perubatan (14 hari)

Application fee & License fees

Copy of current APC

Layout plan of the premises

Detailed plan of the X-ray room where the apparatus will be located Catalogue/detailed of the apparatus to be licensed & copy of supplier license

Completed Completed Borang LPTA/BP/3 or Borang LPTA/BP/3 or letter of intentletter of intent

Private PublicDocuments Required

SUMMARY SUMMARY SUMMARY SUMMARY

Documents required to BUY/ STOREBUY/ STORE Irradiating ApparatusDocuments required to BUY/ STOREBUY/ STORE Irradiating Apparatus

Operators – Med. check up/Film badge/ CME

QC of Equipment CertificatesQC of Equipment Certificates

Private PublicDocuments Required

Licensee/supervisor/RPO – CME

FRRA Report

Audit Film Report *

* GP Clinics

Documents required to STORE/USESTORE/USE Irradiating ApparatusDocuments required to STORE/USESTORE/USE Irradiating Apparatus

Cont..Cont..Cont..Cont..

Protection &Safety

OVERALLOVERALL

Image Quality

SummarySummary

Thank You For Your Thank You For Your AttentionAttention

PERINTAH-PERINTAH AMPERINTAH-PERINTAH AM

BAB C:BAB C: CUTICUTI

47 Cuti Khas Perubatan

PERINTAH-PERINTAH AMPERINTAH-PERINTAH AM

BAB C:BAB C: CUTICUTI

47 Cuti Khas Perubatan

(i) Pegawai yang menjalankan tugas x-ray sepenuh masa dan terdedah kepada pancaran x-ray

(i) Pegawai yang menjalankan tugas x-ray sepenuh masa dan terdedah kepada pancaran x-ray

TEMPOH : 14 hari setahun. Tidak boleh dikumpul dan hendaklah diambil dalam tahun yang ianya diperolehi

TEMPOH : 14 hari setahun. Tidak boleh dikumpul dan hendaklah diambil dalam tahun yang ianya diperolehi

Kelayakan :Kelayakan :

(ii) Pegawai di pusat-pusat perubatan tertentu di mana jenis- jenis tugas yang dijalankan adalah atau tidak digemari. Pusat-pusat perubatan ini hendaklah seperti yang diluluskan oleh Ketua Pengarah Perkhidmatan Awam dari masa ke semasa

(ii) Pegawai di pusat-pusat perubatan tertentu di mana jenis- jenis tugas yang dijalankan adalah atau tidak digemari. Pusat-pusat perubatan ini hendaklah seperti yang diluluskan oleh Ketua Pengarah Perkhidmatan Awam dari masa ke semasa

BackBack

PARAMETERSOPTIMUM

ACHIEVABLE STANDARD

REMEDIAL LEVEL

SUSPENSION LEVEL

1. X-Ray Generatori) Accuracy of kVp Max. Deviation

5% or 5kV whichever is smaller.

> 5 % > 20 %

ii) Accuracy exposure time

a) for time 0.1sec b) for time < 0.1 sec

Maximum Deviation : 10%

20%> 10 %> 20 %

> 25 %> 30 %

iii) Exposure reproducibility

Maximum deviation 10%

> 10 % or baseline

> 20 %

>30 % or baseline >50 %

iv) Exposure linearity Maximum deviation : 10%

> 10 % or baseline

>20 %

> 30 % or baseline >50 %

X-RAY EQUIPMENT Safety and Performance Standard (General X-ray)


PARAMETERSOPTIMUM

ACHIEVABLE STANDARD

REMEDIAL LEVEL

SUSPENSION LEVEL

2. X-Ray Beam Limitationi) Beam Collimation Max. misalignment

1o of SID on any

side

> 1o

> 3o

ii) Beam perpendicularity Less than 2o

> 2o > 3

o

3. X-Ray Beam FiltrationBelow 50 kVp 30 40

mm Al0.30.4

mm Al< 0.3< 0.4

50 to 70 50 60 70

1.21.3 1.5

< 1.2< 1.3 < 1.5

> 70 80 100 130

2.32.73.5

< 2.3< 2.7< 3.5

Cont….



PARAMETERSOPTIMUM

ACHIEVABLE STANDARD

REMEDIAL LEVEL

SUSPENSION LEVEL

4. Image Quality i) Resolution ii) Contrast

Please specify the resolution and contrast

and attach test film

Baseline ± 2 group -

5. Leakage RadiationExposure from the leakage radiation at 1m from the x-ray tube in an hour at every rating specified by the manufacturer.

0.1mGy (10mR) > 0.1mGy (10mR)

> 1.0 mGy (100 mR)



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Act and regulatory requirements hotel selesa 9 jun2012

Education

atomic energy licensing

additional requirements audit

ray equipment safety

therapeutic medical exposure

radiation protection

occupational exposure

ray units

guidance levels