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Act and regulatory requirements hotel selesa 9 jun2012

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CME for GP's at Hotel Selesa Pasir Gudang (9 Jun 2012)

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Act and regulatory requirements hotel selesa 9 jun2012

  1. 1. ACT 304 AND RELATEDREGULATORY REQUIREMENTS IN DIAGNOSTIC RADIOLOGY Muhammad Khalis Bin Abdul Karim Radiation Health and Safety Unit Johor State Health Department Ministry of Health Malaysia
  2. 2. ContentsBackgroundAtomic Energy Licensing Act 1984(Act 304)Subsidiary regulations under Act 304Regulatory and LicensingRequirements in Diagnostic Radiology
  3. 3. Part IBackground
  4. 4. Legislation Hierarchy 1 Act Regulations Legally 2 Bound Circulars/ Standards 3 & Code* Local Rules, 4 Guidelines, Voluntary Instructions Manual* Not regulatory by itself but becomes regulatory if linked to Regulations/Acts
  5. 5. In the numbers(1) 6,570 radas
  6. 6. Malaysian LegislationRadioactive Substance Act 1968- First legislation regulating the use of ionising radiation.- MOH control the use of ionising radiation for medical and non-medicalAtomic Energy Licensing Act 1984 (Act 304)- Replaces and supersedes Radioactive Substance Act 1968.- Act under MOSTI
  7. 7. Cont..• Act 304 was gazetted under the purview of Ministry of Science, Technology and Innovation Malaysia (MOSTI).• 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 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.
  8. 8. Regulatory Authority Atomic Energy Licensing Board (AELB) (Regulatory Authority) Authority Medical Non-Medical Ministry of Health Ministry of Science, Tech and Malaysia Innovation (MOSTI) Director General of Health Executive Secretary to the (Regulatory Authority) Authority Board Secretariat: Secretariat :Radiation Health & Safety Section AELB (Dept) (RHSS), MoH
  9. 9. Malaysian LegislationMain ActAtomic Energy Licensing Act 1984 (Act 304)Subsidiary Regulations Radiation Protection (Licensing) Regulations 1986 Atomic Energy Licensing (Basic Safety Radiation Protection (Basic Safety Standard) Radiation Protection) Regulations 2010 Regulations 1988 Radiation Protection (Transports) Regulations 1989
  10. 10. Malaysian Legislation Guidelines/Circulars Malaysian Standards (MS 838) : Code of Practice For Radiation Protection (Medical X-Ray Diagnosis) - 1985 (1st Revision, 2007) Circular on Employment of Trained X-Ray Operators By Private General Practitioners - 1993 Guidelines To Obtain Class C License Under the Atomic Energy Licensing Act 1984 - 1994 Guidelines For Medical Diagnostic Procedures Using X-ray For Women of Childbearing Potential - 1998
  11. 11. Malaysian LegislationContinue..  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 - 2005
  12. 12. Part II Atomic EnergyLicensing Act (Act 304)
  13. 13. Atomic Energy Licensing Act 1984Contents 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
  14. 14. Act 304 Appropriate Authoritya) The Director-General of Health where the activity to be licensed or licensed under this Act is in respect of a medical purposeb) The Board 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
  15. 15. Act 304 Control and licensing12.(1) Without prejudice to the requirementsof any other law, no person shall : a) site, construct or operate a nuclear installation b) deal in, possess or dispose of any radioactive material, nuclear material, prescribed substance or irradiating apparatus unless he is the holder of a valid license
  16. 16. Act 30412.(3) A licence for using any anyradioactive material, nuclear material,prescribed substance or irradiatingapparatus for diagnostic or therapeuticpurposes may be issued ONLY to aregistered medical practitioner,registered veterinary surgeon,radiologist, radiotherapist or registereddentist
  17. 17. Act 304 Condition of Licenses17(1) Licenses issued under this Actshall be subjected to such conditions asmay, be imposed by the appropriateauthority which may in respect of theconditions imposed by it, add to, varyor revoke such conditions at any time.
  18. 18. Act 304 Cancellation, Suspension and Renewal of Licenses22(1) The appropriate authority may at any timeunder any of the following circumstances in itsdiscretion 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
  19. 19. In the numbers(2) 660 radas penyinaran
  20. 20. In the numbers(3) 279 premis swasta
  21. 21. Act 304 Health and Safety25 (1) Every licensee shall comply with allsuch directives as the appropriate authoritymay issue…, including :a) Conditions of exposureb) Dose limitationc) Occupation exposured) Medical exposuree) Exposure of members of the publicf) Accidental exposureg) Emergency exposure
  22. 22. Act 30425 (2) If the appropriate authority has reasonablecause to believe that any workers has been orlikely to be exposed …, licensee shall : a) provide and require such worker to wear approved personnel monitoring devices b) keep records of dose and type of ionizing radiation c) install or use monitoring devices in work places to record the amount of ionizing radiation present d) provide medical examination for such worker
  23. 23. Act 304 Disposal of Radioactive Waste26 (1) No person shall dispose of orcause to be disposed any radioactivewaste without the prior authorization inwriting of the appropriate authority
  24. 24. Act 304 Powers of Seizure and Arrest, Offences and Forfeiture33 (1) & 34 (1) Senior Public Officer authorizeto, with or without warrant :a) Enter the premises, site, nuclear installation or conveyance and there to search and seize such radioactive material, nuclear material, prescribed substance, irradiating apparatus, book or document;b) Arrest 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;
  25. 25. Act 30433(2) Senior Public Officer may if necessary,with or without assistance:-• Break open any door or window or part of the premises, site, nuclear installation or conveyance and there to have ingress thereinto;• Forcibly enter the the premises, site, nuclear installation or conveyance• Remove by force any obstruction to entry, search, seizure and removal as he is empowered to effectd) 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
  26. 26. Act 30438(1) Any radioactivematerial, nuclear material,prescribed substance,irradiating apparatus orradioactive waste in respectof which an offence underthis Act is committed, or anybook, document orconveyance connected withsuch offence is liable toforfeiture
  27. 27. Act 304 Offences39 – Specific offences [(a) – (i)] under thisSection is, on conviction, liable toimprisonment for a term not exceeding 5YEARS or a fine not exceeding RM10,000 orBOTH40(2) Any person who commits anoffence under this Act is liable toimprisonment for a term not exceeding10 YEARS or a fine not exceedingRM100,000 or BOTH
  28. 28. Part III Subsidiary Regulations under Act 304 Radiation Protection (Licensing) Regulations 1986 Atomic Energy Licensing (Basic Safety Radiation Protection) Regulations 2010 Draft Radiation Protection (Medical, Dental and Veterinary Usage of Radiation) Regulations 201__
  29. 29. Radiation Protection (Licensing) Regulations 1986Contents Classification of licenses General Conditions for Obtaining a License Application for, Amendment and Renewal of License License fees - Review fees and application forms – one form for all type of application, etc – still in JKK of LPTA
  30. 30. Classification of Licenses A license to manufacture, trade in, produce, process,Class A purchase, own, possess, use, transfer, handle, sell or store radioactive material A license to manufacture, trade in, ..… or store nuclearClass B material A license to manufacture, trade in, ….. or store irradiatingClass C apparatus A license to transport radioactive material, nuclear material,Class D prescribed substances or their waste A license to export or import radioactive material, nuclearClass E material, prescribed substances, irradiating apparatus or their waste
  31. 31. Cont.. A license to site, to construct or to operate a nuclear Class F installation A license to • dispose of radioactive material, nuclear Class G materials, prescribed substances or their wastes • store of radioactive material, nuclear materials, prescribed substances or their wastes prior to their disposal • Decommission a milling installation, nuclear installation, waste treatment facility, irradiating apparatus or sealed sources apparatus A license to control of activities not covered by classes Class H A to G
  32. 32. General Conditions For Obtaining a Licenses12 (a) The applicant shall employ a person or persons having the necessary knowledge, skill 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, facilities and procedures shall be adequate to protect the health of workers and member of the public and to minimize danger to life, property and the environment
  33. 33. License & Application Fees Category/Type of Irradiating License fee per year in RM Apparatus Dental X-ray units, mobile & RM100 for the first apparatus1 fixed medical x-ray units, mobile veterinary X-ray units RM20 for every additional apparatus X-ray therapy units not RM300 for the first apparatus2 operable above 500kVp RM60 for every additional apparatus CT Scanner units, RM1000 for the first apparatus3 Accelerators, X-ray therapy units operable above 500kVp RM200 for every additional apparatus Application Fee RM15 Reg 15 of Rad. Protec (Licensing) Regulations 1986
  34. 34. Cont.. Category of Sealed Source License fee per year in RM 1 RM100 for the first sourceAny sealed source with activity not greater RM20 for every additional source than 40MBq 2 RM200 for the first source Radiation gauges and other sealed RM40 for every additional source sources not specified in this Schedule 3 RM300 for the first source Medical therapy sources with activity not RM60 for every additional source greater than 400MBq, etc 4 Medical therapy sources with activity RM1000 for the first source greater than 400MBq, irradiation cell for RM200 for every additional source sterilization purposes, etc Reg 15 of Rad. Protec (Licensing) Regulations 1986
  35. 35. In the numbers(4) 21 CT Scan
  36. 36. Atomic Energy Licensing (Basic Safety Radiation Protection) Regulations 2010 15 February 2010
  37. 37. OLD NEW Radiation Atomic Energy Protection (Basic VS Licensing (Basic Safety Standard) Safety Radiation Regulations 1988 Protection) Regulations 2010 Based on ICRP 26,  Based on ICRP 60, 1977 1990 56 provisions  80 provisions Medical Exposure – 5  More provisions on provisions Medical Exposure – 18 provisions
  38. 38. Interpretation“medical exposure” means the exposure exposureincurred by :(a) a patient as part of his medical or dental investigative or diagnostic procedures or treatment;(b) a person who knowingly assists in the support and comfort of patients, other than a person who is occupationally exposed; or(c) a volunteer in a medical research programme that involves radiation exposure; Reg. 3
  39. 39. Atomic Energy Licensing (Basic Safety Radiation Protection) Regulations 2010 ARRANGEMENT OF REGULATIONSPART I - PRELIMINARYPART II - SYSTEM OF RADIATION PROTECTIONPART III - OCCUPATIONAL EXPOSUREPART 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
  40. 40. Cont.. ARRANGEMENT OF REGULATIONSPART V - PUBLIC EXPOSUREPART VI - POTENTIAL EXPOSURE AND SAFETY OF RADIATION SOURCESPART VII - INTERVENTIONPART VIII - SUBMISSION OF DOCUMENTSPART IX - CESSATION OF OPERATIONS, DECOMMISSIONING OR ABANDONMENT OF LICENSED FACILITIESPART X - GENERAL
  41. 41. PART I - PRELIMINARYWorking AreaClassification of Clean Areas, Supervised AreasWorking Areas : and Controlled Areas“clean area” - an area where the annual dose received by a areaworkeris not likely to exceed the dose limit for a member of the public;“controlled area” - area in which specific protection measures and areasafety provisions are required for controlling normal exposures orpreventing the spread of contamination during normal workingconditions, and preventing or limiting the extent of potentialexposures;“supervised area” - an area for which occupational exposure areaconditions are kept under review even though specific protectivemeasures and safety provisions are not normally needed; Reg. 3
  42. 42. PART III - OCCUPATIONAL EXPOSUREClassification of WorkingAreaSupervised Areas and ControlledAreas have to clearly demarcatedand appropriate legible noticesand warning signs bearing theradiation symbol are postedconspicuously in strategic places.QuestionWhere is the area considered as controlledarea in a diagnostic imaging department ??
  43. 43. PART II - SYSTEM OF RADIATION PROTECTIONDose Limit for Workers &Member of Public Whole Body Exposure Dose Limit (mSv/year) BSS 1988 BSS 2010Public 1 1Radiation Workers 50 20*Foetus 10 1* The maximum effective dose on the worker averaged over a period of 5 consecutive years shall not exceed 20mSv Reg. 8 & 9
  44. 44. QuestionWhat is the patient dose limit ?A: 1 mSv/year PublicB: 20 mSv/year Radiation workers (new BSS Regulations – 2010)C: 50 mSv/yearD: 150 mSv/year Radiation workers (old BSS Regulations 1988)ANS: NO LIMIT Lens of the eyes
  45. 45. Personnel Monitoring(1) The licensee shall be responsible for arranging the assessment of the occupational exposure of workers(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.(3) Personnel monitoring shall not be required for any worker who normally works in a supervised area, or area 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 Reg. 22
  46. 46. PART IV - MEDICAL EXPOSUREResponsibilities of licensee oremployerTo ensure that :(a) no 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 assigned 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; Reg. 41
  47. 47. Cont…(c) an appropriate healthcare professional who is adequately 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 assurance programme specified by the appropriate authority is conducted by or under the supervision of a qualified expert in medical physics;
  48. 48. Operational consideration fordiagnostic exposure(1) For diagnostic radiology practices, the licenseeshall ensure:(a) the exposure of patients is at the minimum level required in order to achieve the intended diagnostic objective;(b) the relevant information from previous examinations is taken into account in order to avoid unnecessary additional examinations; and(c) the relevant guidance levels as specified in the Sixth Schedule is taken into account. Reg. 48
  49. 49. Cont…The licensee shall ensure that …the diagnostic procedure chosen to produce theminimum exposure to patient is consistent with theacceptable image quality and the clinical purpose of theexamination.the portable and mobile radiological equipment is usedonly for examinations where it is impractical or notmedically acceptable to transfer patients to a stationaryradiological installation, and only after proper attentionhas been given to the radiation protection measuresthat are required in its use.
  50. 50. Cont…The licensee shall ensure that …any radiological examination causing exposure to the abdomen or pelvis of women who are pregnant or suspected to be pregnant is avoided, unless there are avoided strong clinical indications for such examinations.any diagnostic examination of the abdomen or pelvis of women 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 radiosensitive organs such as gonads, lens of the eye and thyroid is provided. provided
  51. 51. Clinical dosimetryFor clinical dosimetry, the licensee shall ensurethat the following items are determined anddocumented:documented (a) in radiological examinations, the representative values for typical sized adult patients of entrance surface doses, dose-area products, dose rates and exposure times, or times organ doses; doses 52. (1)(a)
  52. 52. Quality assurance for medicalexposure53. (1) The licensee shall establish a comprehensive QAPfor medical exposure with the participation of appropriatequalified experts in the relevant fields as specified by theappropriate authority. (2) The quality assurance programmes for medical exposure shall include: (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
  53. 53. Guidance levels for MedicalExposure• As a guide by approved registered medical practitioners, in order that : (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. Reg. 54 (1)
  54. 54. Tables I of the Sixth Schedule GUIDANCE LEVELS FOR DIAGNOSTIC RADIOLOGICAL PROCEDURESGuidance levels of dose for diagnostic radiography for a typical adult patientExamination Projection ESD per radiograph * (mGy)Lumbar spine AP 10 LAT 30 LSJ 40Abdomen, 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 of200. For high speed film screen combinations (400-600), the values should be reduced by a factor of 2 to
  55. 55. Tables II of the Sixth ScheduleDose guidance levels for computed tomography for a typical adult patientExamination Multiple scan average dose (mGy)Head 50Lumbar spine 35Abdomen 25
  56. 56. European Guidance Levels for ComputedTomography for a Typical Adult Patient and Children 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
  57. 57. Investigation, notification andreporting of accidental medicalexposure(1) The licensee shall notify the appropriate authority of all accidental medical exposures within 24 hours after the occurrence of such accidental medical exposures. Reg. 57 (1)
  58. 58. Cont…(2) The licensee shall immediately investigatethe following accidental medical exposures:(b) diagnostic exposure substantially greater than intended or resulting in doses repeatedly and substantially exceeding the established guidance level as specified in the Sixth Schedule;(c) any equipment failure, accident, error, mishap or other unusual occurrence with the potential for causing a patient exposure significantly different from that which is intended. Reg. 57 (2)
  59. 59. Cont…(3) The licensee shall, with respect to any investigation carried out under subregulation (2)(a) calculate or estimate the doses received and their distribution within the patient;(b) indicate the corrective measures required to prevent recurrence of such an incident;(c) implement all the corrective measures that are under his responsibility;(d) submit a written report within 30 days after the completion of the investigation stating the cause of the accidental medical exposure to the appropriate authority, and authority(e) inform the patient and the approved registered medical practitioner about the incident.
  60. 60. Records58. (1) The licensee shall keep for a period asmay be specified by the appropriate authorityand make available, when required, thefollowing records:(a) in diagnostic radiology, necessary information to allow retrospective dose assessment, including the number of exposures and the duration of fluoroscopic examinations;
  61. 61. Prevention of accidentsThe licensee shall make suitable arrangements to prevent anyaccident that could reasonably be foreseen for any radiation sourceand to limit the consequences of any accident that occurs. (a) adequate 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 safety are inspected and tested for any degradation that could lead to abnormal conditions or inadequate performance; (c) appropriate maintenance, inspection and testing are carried out without undue occupational exposure; (d) appropriate automatic systems for safely shutting off or reducing radiation 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 abnormal operating conditions that can significantly affect the protection or safety and to allow for timely corrective action to be taken, is provided. Reg. 67
  62. 62. Notification of theft, loss orsabotageThe licensee shall, upon discovering any theft, loss orsabotage of any radiation source in his possession orunder his control : (a) notify the appropriate authority of such theft, loss or sabotage within 24 hours after discovering the theft, loss or sabotage; and (b) submit a complete report of the theft, loss or sabotage in writing within 30 days after the notification to the appropriate authority. 71. (1)
  63. 63. Notification of theft, loss or sabotage…contThe 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.
  64. 64. Submission of DocumentsThe appropriate authority may require the licensee to submit any orall of the followings:(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. Reg. 77
  65. 65. PART X - GENERALTransitional provisionsA person who holds a licence issued underthe Act in relation to activities involvingionizing radiation that is still in force at thedate of commencement of these Regulationsshall, within 2 years from the date ofcommencement, comply with therequirements under these Regulations. Reg. 79
  66. 66. Draft Radiation Protection (Medical, dental and veterinary Usage of Radiation) Regulations 20__- More comprehensive regulation to control the use of ionizing radiation in medicine under the purview of MoH - 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
  67. 67. Cont..Contents 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
  68. 68. In the numbers(5) 238 radiografi am
  69. 69. Part IV Regulatory & LicensingRequirements in Diagnostic Radiology
  70. 70. Circular to Private Hospital/GP’s Clinics Issued on 21 Oct 1999Requirements Effective date• Only Trained Personnel (GP’s Clinic) – 1.1.2000• At least 1 qualified radiographer – 1.1.2000 (Private Hosp) Training of New Applicants – 1.1.2000 Implementation 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)
  71. 71. Circular to TKPK (Medical) and TKPK (Public Health) – 15.1.2001All plans for facilities under Act304 to be submitted and approvedby Radiation Health and SafetyBranch, Engineering ServicesDivision before commencement ofinstallation/renovationAll related equipment and facilities to betested, commissioned and verified to conformto safety and performance standards beforeclinical use
  72. 72. Cont… Implementation of QAP • Quality control (QC) of equipment, processors and associated facilities • Monitoring and analysis of film reject rate • Continuous Professional Education (CME)
  73. 73. Procedures To Apply For A License(Private) or Getting Approval (Public) STEP 1 Requirements to BUY & STOR Irradiating Apparatus STEP 2 Requirements to USE Irradiating Apparatus
  74. 74. Step 1 Documents required to apply for BUY & STORE Irradiating Apparatus Application form (private) or letter of intent (public) Application/Licence fee (private) Copy of current APC The address of practice stated in APC shall be the same as the address of where apparatus is to be stored or used Layout plan of the premises Detailed plan of the room where the apparatus will be located Description of irradiating apparatus
  75. 75.  FACILITIES Layout plan of premises Layout plan of premises shall indicate - Location of the x-ray room, darkroom & occupied area in the premise - All plan shall be in technical drawings & the scale shall be in metric (S.I) unit Note: No licence will be issued for X-ray practice in free standing laboratory where there is no doctor practicing in the premise
  76. 76.  FACILITIES Detailed Plan of X-ray Room & Dark Room Detailed Plan of X-ray room shall clearly specify the following : 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
  77. 77.  X-RAY ROOM- Layout and Dimension Type of Equipment General X-Ray * Fluoroscopy Plan Spec. Dimension of the room 3.0 m x 4.0m 6.0 m x 4.0m Thickness of Shielding at the 2.0mm Pb eq 2.0mm Pb eq Doors and Walls Dimension & Thickness of Lead 1.2m x 1.2m x 1.2m x 1.2m x at the Chest Wall 2.0mm Pb eq 2.0mm Pb eq Dimension & Thickness of Lead 35cm x 30cm x 100cm x 50cm x Glass Observation Window 2.0mm Pb eq 2.0mm Pb eq Dimension & Thickness of Lead 1.2m x 2.5mx 1.2m x 2.5mx at the Floor (upper floor) 2.0mm Pb 2.0mm Pb * Control panel outside with examination table Cont….
  78. 78.  X-RAY ROOM- Layout and Dimension Type of Equipment Mammography CT Scanner Plan Spec Dimension of the room 2.5 m x 3.0m 5.5 m x 4.0m Thickness of Shielding at the 1.0mm Pb eq 2.0mm Pb eq Doors and Walls Dimension & Thickness of Lead NA NA at the Chest Wall Dimension & Thickness of Lead NA 100cm x 50cm x Glass Observation Window 2.0mm Pb eq Dimension & Thickness of Lead NA 1.2m x 2.5mx at the Floor (upper floor) 2.0mm NA - Not applicable Cont….
  79. 79.  X-RAY ROOM- Warning Signs - All entrances to x-ray rooms shall be marked R 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. 1.5 R  R is the radius of theis correct ? Which one inner 5R circle and 5R is not less than 7.5 cm MS 838:1985 Cont….
  80. 80. New Radiation Symbol ????New Symbol launched to warn public about radiationdangers - supplementary symbol aims to help reduceneedless deaths and injuries, IAEA – 15 February 2007
  81. 81.  X-RAY ROOM- Warning Light 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 Cont….
  82. 82.  DARKROOM- Dimension & Location Minimum Dimension of = 1.5m x 2.0m Darkroom Location of darkroom shall not be in the direction of the useful beam. MS838:2007
  83. 83. Step 2 Requirements to STORE & USE Irradiating Apparatus• Personnel & Licensee/Org Yg Bertanggungjawab Training Supervisor RPO Operators • Facility X-ray Room Dark room • Equipment X-ray Machine Processor/cassette/Viewer, etc • Procedures Local rules, etc
  84. 84. Requirements to STORE & USE Irradiating Apparatus Licensee/Org Yg Bertanggungjawab : GP clinics/Non X-ray Sp. Clinics/Health Clinics Registered Medical Doctor undergo 40 credit hours training program (new applicant) Hospital/Radiological Clinic Registered Med. Doc/Pengarah@ Radiologist Attend continuous professional education (CME) program
  85. 85. Requirements to STORE & USE Irradiating Apparatus Supervisor : GP clinics/Non X-ray Sp. Clinics/Health Clinics Registered Medical Doctor Attend yearly continuous professional education (CME) program Hospital/Radiological Clinic Radiologist Attend yearly continuous professional education (CME) program
  86. 86. Requirements to STORE & USE Irradiating Apparatus Radiation Protection Officer (RPO) : GP clinic/Non X-ray Specialist Clinic Registered Medical Doctor or radiographer Attend yearly continuous professional education (CME) program Hospital/Radiological Clinic Med. Physicist/Radiologist/radiographer Attend yearly continuous professional education (CME) program
  87. 87. Requirements to STORE & USE Irradiating Apparatus X-ray Operator : GP clinic/Non X-ray Sp. Clinic 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
  88. 88. Training Syllabus For New Licensees &New OperatorsDoctors applying for new licences and newly employedoperators are required to undergo the following coursesbefore they are permitted to use the x-ray equipment Mod. 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
  89. 89. Existing X-ray Operator*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 ANM2. Workers trained in programme approved by the Licensing Authority – the training syllabus and facilities would be vetted before approval is given3. Medical practitioners * Subjected to do chest & extremities only
  90. 90. Requirements to STORE & USE Irradiating ApparatusHospital/Radiology clinic Employment of at Least 1 Radiographer Mammography 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
  91. 91. Medical Surveillance (Buku LPTA/BM/5)Nota: Pemeriksaan x-ray dada hanya perlu Question:dibuat utk jangkamasa lima (5) tahunsekali; atau apabila difikirkan perlu oleh Do you require topengamal perubatan berdaftar yang do chest x-ray fordiluluskan. medical check-up every time?
  92. 92.  CME All personnel 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. 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
  93. 93.  CME All personnel 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
  94. 94.  FACILITIES & X-RAY EQUIPMENT Safety and Performance Standard QC of Equipment and Associated Facilities:  Tested & certified by consultant medical physicist approved by MoH – Class H (certification)  Submit certificate with summary report and full report to MoH
  95. 95.  FACILITIES & X-RAY EQUIPMENT Safety and Performance Standard Facility/ Parameter Optimum Achievable Std Equipment Machine Irradiating performance As specified in the Standard  Apparatus parameter Exp. rate at every occupied outside the x-ray room and at the X-Ray Room Scattered Radiation position normally occupied by the operator at the control area shall not exceed 10mR in one week Condition of the Dark Room No light leakage dark room No light leakage Condition of all the Cassettes Film and screen should be in good cassettes contact
  96. 96.  ADDITIONAL REQUIREMENTS Monitoring & analysis of film reject rate  Monitoring and Analysis of Film Reject Rate A report of monitoring and analysis of film reject rate shall be submitted every year. It should include the following: i. Monitoring Period ii. No. of film used iii. No. of film rejected and percentage • Corrective action taken when reject rate > 10%
  97. 97.  ADDITIONAL REQUIREMENTS Audit of X-Ray Radiographs  Audit of X-ray Radiographs* i) Film Audit by Radiologist 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 * For GP’s Clinic/Sp. Clinic only
  98. 98.  ADDITIONAL REQUIREMENTS Audit of X-Ray Radiographs 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
  99. 99. QuestionDoes ‘radiation leave’ coverunder Act 304 or subsidiaryregulations ?AnswerNOPerintah Am Bab C – 47 Cuti tugas khas perubatan(14 hari) 
  100. 100. SUMMARYDocuments required to BUY/ STOREIrradiating Apparatus Documents Required Private Public Completed Borang LPTA/BP/3 or letter of intent   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  
  101. 101. Cont..Documents required to STORE/USEIrradiating Apparatus Documents Required Private Public QC of Equipment Certificates   Licensee/supervisor/RPO – CME   Operators – Med. check up/Film badge/ CME   FRRA Report   Audit Film Report *   * GP Clinics
  102. 102. Summary OVERALL Protection &Image Quality Safety
  103. 103. Thank You For Your Attention
  104. 104. PERINTAH-PERINTAH AMBAB C: CUTI47 Cuti Khas PerubatanKelayakan :(i) Pegawai yang menjalankan tugas x-ray sepenuh masa dan terdedah kepada pancaran x-ray(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 TEMPOH : 14 hari setahun. Tidak boleh dikumpul dan hendaklah diambil dalam tahun yang ianya diperolehi Back
  105. 105.  X-RAY EQUIPMENT Safety and Performance Standard (General X-ray) OPTIMUM ACHIEVABLE REMEDIAL SUSPENSION PARAMETERS STANDARD LEVEL LEVEL 1. X-Ray Generator ii) Accuracy of kVp Max. Deviation ± 5% >5% > 20 % or ± 5kV whichever is smaller. ii) Accuracy exposure time Maximum Deviation : a) for time ≥ 0.1sec ± 10% > 10 % > 25 % b) for time < 0.1 sec ± 20% > 20 % > 30 % Maximum deviation ± > 10 % or >30 % or iii) Exposure baseline 10% baseline reproducibility >50 % > 20 % iv) Exposure linearity Maximum deviation : 10% > 10 % or > 30 % or baseline baseline >20 % >50 %
  106. 106.  X-RAY EQUIPMENT Safety and Performance Standard (General X-ray) OPTIMUM ACHIEVABLE REMEDIAL SUSPENSION PARAMETERS STANDARD LEVEL LEVEL 2. X-Ray Beam Limitation ii) Beam Collimation Max. misalignment 1 o o o >1 >3 of SID on any side o o o ii) Beam perpendicularity Less than 2 >2 >3 3. X-Ray Beam Filtration mm Al mm Al Below 50 kVp 30 0.3 < 0.3 40 0.4 < 0.4 50 to 70 50 1.2 < 1.2 60 1.3 < 1.3 70 1.5 < 1.5 > 70 80 2.3 < 2.3 100 2.7 < 2.7 130 3.5 < 3.5 Cont….
  107. 107.  X-RAY EQUIPMENT Safety and Performance Standard (General X-ray) OPTIMUM REMEDIAL SUSPENSION PARAMETERS ACHIEVABLE LEVEL LEVEL STANDARD 4. Image Quality i) Resolution Please specify Baseline ± the resolution 2 group ii) Contrast and contrast and - attach test film 5. Leakage Radiation Exposure from the leakage 0.1mGy (10mR) > 0.1mGy > 1.0 mGy radiation at 1m from the x-ray (10mR) (100 mR) tube in an hour at every rating specified by the manufacturer. [back]

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