ANNEX 9 : REQUIREMENTS FOR AUTHORISATION

RADIATION PROTECTION AUTHORITY OF ZIMBABWE

RADIATION PROTECTION ACT (CHAPTER 15:15)

REQUIREMENTS FOR MEDICAL X-RAY FACILITIES

a) Administrative Requirementsi. Completion and submission of the attached Authorization Application Form. The Form and the

Guide for filling the Form could also be downloaded from the RPAZ website at www.rpaz.co.zw.ii. Payment of applicable authorization fees in accordance with SI 134 0f 2012iii. Type of licence applicationiv. Purpose of applicationv. Appointment of the legal person

b) Personnel/Training requirementsi. Radiographer / radiologist/ x ray operator with recognized training and registered with

local professional board.ii. Appointment of/designation of a Radiation Safety officer (RSO) indicating his job

description and authority to stop unsafe practice. iii. Working experience of radiographers/ radiologists/ x ray operatorsiv. Copies of academic professional qualifications and CVs of staff and letters of their

appointments.

c) Facility and Equipment design

a) The floor area of the room shall be at least 20m2 and the ceiling 3m above the floor for General X Ray and 25m(2 )for Computerised Tomography CT room

b) Wall thickness shall be equivalent to 2mm lead or plastered double solid brick walls (25cm thick) or 15cm concrete.

c) All doors shall be lined with 2mm lead and should have an overlap of at least 2cm with the frame.

d) All the entrances to x-ray rooms shall have sliding doors.e) A red warning light synchronized to the machine shall be fitted at the entrance to the

examination room, above the door.f) Doors shall be fitted with a mechanical interlock system.g) A radiation warning sign (trefoil) shall be posted on all entrances.

1 McCaw DriveAvondaleBox A1710AvondaleHarareZimbabwe

Phone: +263 4 335627+263 4 335683

Email: officialmail@rpaz.co.zwWebsite: www.rpaz.co.zw

h) Warning notices shall be written and posted on all entrances in English, Shona and Ndebele.

i) Windows shall be at least 2m above the ground outside.j) An operator’s control cubicle/shield fitted with a 30x 30 cm window of 2mm lead equivalent

must be provided and positioned in the room such that the least possible exposure is received by the operator.

k) Dose rates within the control cubicle shall be less than 2.5µSv per hour.l) The primary wall shall be at least 2.5mm thick lead with no windows on it. The darkroom

shall not be constructed behind this wall.m) At least 2 lead aprons and gonad shields shall be provided and a changing area made

available.n) The darkroom shall be light proof, have a safelight, have an extractor fan and be ideally

linked to the X-ray room via a maze.

Additional Requirements for CT scanning equipmenti. Acceptance test/ Commissioning testii. Maintenance and repair programmeiii. Quality control testiv. Calibration certificates.

D) Application for AuthorizationThe application for shall include

I) Radiation Protection Programme The Radiation Protection Programme for an application for authorization should include the following:

Details of the Operator including qualifications of RSO and Qualified Experts where appropriate Identification of the individual(s) representing the operator;

Details of qualifications and training in radiation protection of workers engaged in activities that involve or could involve occupational exposure;Details of Qualification of personnel as specified in S.I 62 of 2011 are to be included practices involving medical exposure, “the qualifications in radiation protection of the medical practitioners who are to be so designated by name in the registration or licence; or a statement that only Medical Practitioners with qualifications in radiation protection specified in the relevant regulations or to be specified in the registration or licence will be permitted to prescribe medical exposure by means of the authorized source” as required.

Justification for engaging in the regulated activity or practice for…..shall be submitted including copies of operating and maintenance procedures. For significant risk radiation sources, unusual or complex practices, or consumer products, a justification for engaging in the regulated activity or practice s;

A plan of the premises with an assessment of the nature, magnitude and likelihood of exposures attributable to the radiation source(s) made by the Radiation Protection Officer or a Qualified Expert; shall be submitted.

The occupational radiation protection programme, including arrangements for monitoring of workers and the workplace, and the provision and maintenance of personal protective equipment and equipment for radiation detection;

For practices involving medical exposure, information relating to the radiological protection of patients, including arrangements for the calibration of sources used for medical exposure, clinical dosimetry and quality assurance programmes;

Radiation protection of the public, where appropriate, with all pathways of exposure taken into account;

Arrangements to ensure safety of sources; A radioactive waste management , including the management of disused sources,

return to supplier policy Emergency Preparedness Plan arrangements and financial arrangements for a

radiological emergency, where appropriate”ii) Personnel/Worker Protection

1) Licensees should ensure that all persons engaged in activities that involve occupational radiation exposure are provided with suitable and adequate protective clothing and Individual monitoring devices.

2) The appropriate protective clothing and devices should include lead equivalent aprons, thyroid shields, protective eye wear and gloves

Aprons should be equivalent to at least 0.25 mm Pb if the X-ray equipment operates up to 100kV and 0.35 mm Pb if it operates above 100kV.

Aprons should be stored on hangers and not folded for storage Aprons should be tested at approximately 12-18 months intervals for shielding

integrity. Any suspected damage to the Apron should be reported immediately and the apron not

used until it has been tested and declared safe Additional Requirements for Interventional Radiology Interventional radiology staff should always use 0.5mm lead equivalent protective

devices. Thyroid protection should be used be by interventionist (radiologist, cardiologist,

neuroradiologist etc.)when using high radiation doses and dose rates during interventional radiology procedures

3) Proper use of a suspended protective barrier between the patient and the interventionist should be used to reduce the need for separate thyroid protection.

4) All lead vinyl material should comply with relevant international standards. They should be tested soon after purchase and the regularly at least every year.

5) Mobile Radiography Staff using mobile X-ray equipment should make available a lead protective

apron to any person who is required to remain less than 2m from the patient under examination.

6) If conventional (adult) x ray equipment is used for babies and small children, the grid should be removed wherever applicable. AEC must be calibrated for different sizes and stature of children.

7) Female workers shall be advised by the licensee or registrant that it is desirable to notify the employer of pregnancy. Once a female worker has notified the employer that she is pregnant, the employer shall adapt the working conditions in respect of occupational exposure so as to ensure that the embryo is afforded the same broad of protection which is required for members of the public. The notification of pregnancy shall not be considered a reason to exclude a female worker from work.

8) Any person between the ages of 16 – 18 year shall not be allowed to work in controlled areas unless supervised and only for training purposes.

iii) Quality assurance program.

The licensees and/or registrant should establish a comprehensive Quality assurance program for radiation protection, safety and image quality that is compliance with applicable regulations and is within terms and conditions of authorisation.

1) The quality assurance program shall include: Procedures to ensure that the medical exposures are in accordance with those

prescribed by a medical practitioner Patient dose evaluation Quality control of the x ray system Training and continuing education of staff Clinical audits Procedures for remedial actions, follow up and result evaluation2) The quality control procedures manual should contain protocols for performing the

different tests with indications on: The measuring instruments or tools to be used The operational details The level of qualification required to the staff performing the test The recommended frequency The limiting values for and tolerances in the results

3) The following procedures should be included: Acceptance tests are performed on new equipment to demonstrate that it is performing

within the manufacturers specifications and criteria Performance tests are specific tests that are performed on the x ray system in use after

a certain amount of time has elapsed Constancy tests Status tests ( full testing at longer periods eg annually) Calibration of quality control test equipment Follow up of any corrective actions required as a result of quality control tests4) The quality control instruments include the following: Instruments to check the electromechanical performance of the X ray system Instruments to verify the accuracy of the radiation control settings eg KVP meter Ionisation chambers and electrometers to measure and absorbed dose Phantoms to measure image quality e.g. spatial resolution

e) Inspection

Furthermore, upon receipt of your completed application form, applicable fees and documents reflecting the requirements listed above, a date shall be fixed for inspection of your facility. The authorizations shall be issued upon a satisfactory report of the inspection exercise.

RADIATION PROTECTION AUTHORITY OF ZIMBABWE (RPAZ)

MINIMUM REQUIREMENTS FOR AUTHORIZATION TO TRANSPORT RADIOACTIVE MATERIAL WITHIN OR OUTSIDE ZIMBABWE AND TO TRANSIT THROUGH ZIMBABWE

Requirements for the transport and transit of radioactive material should be applied in addition to the following regulations:

- Radiation Protection Act [Chapter 15:15] of 2004- Statutory Instrument 62 of 2011, Radiation Protection (Safety and Security of Radiation

Sources) Regulations;- Statutory Instrument 106 of 2011, Radiation Protection (Safety and Security of

Radiation Sources) (Amendment) Regulations;- Statutory Instrument 134 of 2012 (Fee Schedule), Radiation Protection (Safety and

Security of Radiation Sources) (Amendment) Regulations (No 2);- IAEA Regulations for the Safe Transport of Radioactive Material (SSR-6) [2012

Edition]

Note that this minimum requirement is not exhaustive and does not in any way preclude other decisions by RPAZ.

a) Licensing FeesUnder the Radiation Protection Act (Chapter 15:15) section 9(c) and 22(g) of the Act, RPAZ is empowered to charge fees for the licensing of radiation generating apparatus. The applicant is therefore required to pay applicable authorization fees in accordance with Statutory Instrument 134 of 2012 (Fee Schedule), Radiation Protection (Safety and Security of Radiation Sources) (Amendment) Regulations (No 2); and Statutory Instrument 106 of 2011, Radiation Protection (Safety and Security of Radiation Sources) (Amendment) Regulations;

b) Administrative Arrangementsi. Nature of practiceii. Memorandum of Articlesiii. Certificate of Registration, CR 14, CR 6iv. VAT Certificate and Tax clearance Certificate Name of the Legal Persons of the

company including the Chief Executive Officerv. Name, Addresses and locations of company in Zimbabwevi. Name of Legal Persons of Company (Managing Director, Chief Executive Officer etc.)vii. List of Staff and their qualifications and relevant trainings

viii. Organogram of company showing line of authorityix. Scope of work in Zimbabwex. Designation of an officer as Radiation Safety officer (RSO) who shall develop skills in

basic radiation safety and understand the regulatory requirements for practices involving radioactive materials and ionizing radiation

c) For transport within the countryObtain and submit a duly completed Application for Authorization to Transport/Transit Radiation devices/materials form (the form can also be downloaded from the RPAZ website: www.rpaz.co.zw or collected at our offices) together with documentation providing the following information:

i. port of entry/exitii. the source certificates, leak test report obtained within the last 6 monthsiii. Payment of the requisite RPAZ transport feeiv. Specification of the radioactive substances to be transported in any conveyance –

type, physical and chemical characteristics, quantity, activity, numbers according to the unified classification of the UN (UN No.)

v. specification of the transport packages – type, category, transport index;vi. The chosen transport mode within the country - road, rail, air, or combined transport. In

the case of combined transport, the intermediate points between the departure and arrival points and identification data for the contact persons authorized by the carrier shall also be specified.

vii. Document regulating the relations between the applicant and the subcontractors to participate in the transportation.

viii. In the case of export, transport permits and corresponding import authorizations issued by the competent authorities of the country of destination and of the states of transit.

ix. Radiation Protection Programme x. Documents demonstrating the applicant’s obligation to return the consignment to the

starting point and the consignor’s obligation to accept the consignment back in case of non-delivery.

d) For transport through the country (Transit)

Obtain and submit a duly completed Application for Authorization to Transport/Transit Radiation devices/materials form (the form can also be downloaded from the RPAZ website: www.rpaz.co.zw or collected at our offices) together with documentation providing the following information:

i. port of entry and exitii. The expected date of entry and exit of the shipmentiii. the source certificates, leak test report obtained within the last 6 monthsiv. Payment of the requisite RPAZ transport feev. Specification of the radioactive substances to be transported in any conveyance –

type. physical and chemical characteristics, quantity, activity, numbers according to the unified classification of the UN (UN No.)

vi. specification of the transport packages – type, category, transport index.vii. The chosen transport mode within the country - road, rail, air, or combined transport. In

the case of combined transport, the intermediate points between the departure and arrival points and identification data for the contact persons authorized by the carrier shall also be specified.

viii. Document regulating the relations between the applicant and the subcontractors to participate in the transportation.

ix. Transport route within the state, including the scheduled transit stops.x. Documents regulating the relations between the consignor and consignee and

between the applicant and the contractors to participate in the shipment within the territory of the state.

xi. Transport permits and corresponding import and export authorizations issued by the competent authorities of the state of departure, destination and of the states of transit.

xii. Radiation Protection Programmexiii. Depending on the radioactive substances type and characteristics, the applicant may

be requested to submit:a). Document confirming that the physical protection is ensured b). Instruction for physical protection.

e) Radiation Protection ProgrammeThe Radiation Protection Program shall describe, where appropriate:

i. The persons in charge of the transport safety (RSO) and evidence of basic radiation safety training

ii. Personnel to take part in the transport operations e.g vehicle driver iii. Route plan iv. Emergency proceduresv. Quality assurance programvi. Labelling and placarding arrangementsvii. Programme for individual monitoring and dose assessments on packages. Also

indicate the devices to be used.viii. Procedures on transfer of radioactive material to consignee or to another transporterix. Procedures for accident and incident investigation

f) Inspection The authority may decide to do an inspection before or during, as appropriate, the transportation of the radioactive material.

g) Personnel Monitoring

All personnel directly involved in the transport of radioactive material should be under Radiation Monitoring Program from an accredited Service Provider.

h) Radiation Safety Officer (RSO)The person appointed as the RSO shall ensure that:

i. There is appropriate monitoring devices for transport packages and all persons involved in transporting the radioactive material and any other protective accessories necessary to carry out radiation procedures with the lowest possible riskThe expected date of entry and exit of the shipment

ii. Transport packages are properly labeled and secured, and that the conveyances have appropriate placards.

iii. Practical segregation distances are employed.

iv. All radiation workers employed within the facility are given proper instruction on radiation safety measures and, where annual exposure exceed three-tenths of the dose equivalent limit, receive medical check-ups at least once every six months.

v. Proper care is taken of radioactive wastes if they appear in the course of the use of radiation sources as described in the codes of practice issued by RPAZ for protection of persons exposed to ionizing radiation and that the wastes are only disposed of in accordance with the licence granted for the purpose.

vi. Emergency procedures are followed in the case of an accident.vii. Exposure records are kept as prescribed in the codes of practice for users of ionizing

radiation; andviii. Any other instructions that may be issued from time to time by RPAZ are

implementation.

RADIATION PROTECTION AUTHORITY OF ZIMBABWE

RADIATION PROTECTION ACT (CHAPTER 15:15)

REQUIREMENTS FOR RADIOTHERAPY FACILITIES

a) Administrative Requirementsvi. Completion and submission of the attached Authorization Application Form. The Form and the

Guide for filling the Form could also be downloaded from the RPAZ website at www.rpaz.co.zw.vii. Payment of applicable authorization fees in accordance with SI 134 0f 2012viii. Type of licence applicationix. Purpose of applicationx. Appointment of the legal person

b) Personnel/Training

Category Staffing

Radiation oncologist-in-chief

One per programme

Staff radiation oncologist One additional for each 200–250 patients treated annually. No more than 25–30 patients under treatment by a single physician at any one time.Higher numbers of predominantly palliative patients can be managed.

Radiation physicist One per centre for up to 400 patients annually.Additional in ratio of 1 per 400 patients treated annually.

Treatment planning staff:Dosimetrist or physicsassistant

One per 300 patients treated annually.

RTT-MR (Mould Room) One per 600 patients treated annually

Radiation therapyTechnologist (RTT):Supervisor One per centre

1 McCaw DriveAvondaleBox A1710AvondaleHarareZimbabwe

Phone: +263 4 335627+263 4 335683

Email: officialmail@rpaz.co.zwWebsite: www.rpaz.co.zw

RTT Two per megavoltage unit up to 25 patients treateddaily;

RTT-Sim (Simulator) . Two for every 500 patients simulated annually

RTT-Br (Brachytherapy) As neededNurse One per centre for up to 300

patients treated annually and an additional one per 300 patients treated annually.

Social worker As needed to provide service

Physiotherapist As needed to provide service

Dietician As needed to provide service

Maintenance engineer orelectronics technician

One per two megavoltage units or one megavoltageunit and a simulator if equipment serviced‘in-house’

Physicians

Physicians practising radiation therapy must first be qualified as medical practitioners with a postgraduate training in radiation oncology. Radiation oncologists have knowledge, involving special expertise in the therapeutic applications of ionizing radiation, about the causes, prevention and treatment of cancer and other diseases. They must have an understanding of the biology of cancer and of the biological aspects of the interaction of radiation with tissues as well as of the fundamentals of the physical aspects of radiotherapy.

Radiotherapy medical physicists

The responsibilities of radiotherapy medical physicists cover five major areas:(1) Dosimetry;(2) Radiation safety ;( Roles of the Radiation Safety Officer as promulgated by the Radiation Protection Act Chapter 15:15 of 2004)(3) Treatment planning;(4) Quality control;(5) Equipment selection.

Medical physicists practising in radiotherapy (or radiation oncology) must be qualified as physicists with academic studies in medical physics (typically at postgraduate level) and clinical training in radiotherapy physics. Medical physicists specialized in radiotherapy physics are referred to as clinically qualified radiotherapy physicists. A clinically qualified radiotherapy physicist should have at least:(a) A university degree in physics, engineering or an equivalent physical science.(b) At least one year of academic postgraduate studies leading to a master’s degree in medical physics (or an equivalent). This requires studies in several areas of medicine (e.g., radiodiagnostics, nuclear medicine and radiotherapy).(c) The equivalent of at least two years of full-time comprehensive clinical in service training in radiotherapy physics undertaken in a hospital. This radiotherapy physics residence training will be under the supervision of an experienced or senior radiotherapy physicist. In addition:(i) In the case that the academic studies include a considerable clinical training component, this should be taken into account in the fulfilment of the time requirement.(ii) This training should preferably be approved and certified by a suitable professional body such as the Health Professions Authority of Zimbabwe.

NB: The holder of a university degree in medical physics without the required hospital training cannot be considered to be clinically qualified.

Radiation therapy technologists/therapists/ radiation therapists/ radiotherapists

These personnel are responsible for the following:(a) Operating teletherapy machines: linacs, Co-60 units, and superficial and orthovoltage X ray units;(b) Operating simulator and other imaging devices for therapy purposes: CT scanners and simulators (RTT-Sims);(c) Providing mould room services: production of immobilization masks, lead blocks, etc. (RTT-MRs);(d) Under the supervision of medical physicists, they may also calculate the monitor units for treatment, and operate HDR brachytherapy machines (RTT-Brs) or treatment planning units (RTT-TPSs).RTTs must have a minimum of a diploma in Therapy Radiography from a reputable institution and relevant clinical experience.

Radiation oncology nurses, social workers and dieticians

Appropriate training in nursing equivalent to a State Registered Nurse, together with specialist training in oncology, is required. A social worker trained in oncology is required to help the patient and their family with arrangements regarding transport, employment, care of children, etc. This staff member should be well informed about radiation procedures, in order to allay initial fears and clarify misconceptions arising from communications from technical and medical staff.The role of this staff member in ensuring patient compliance with what are repetitive and unfamiliar procedures is pivotal to achieving a cure. Where necessary, a dietician trained in radiation oncology may assist patients with their nutritional needs during treatment. Radiation oncology nurses may be able to perform some of the duties of the social worker and dietician.

Maintenance personnel

Electronics technicians with the minimum of a National Diploma in either Electronics or Instrumentation together with Medical Physicists must be trained at least to carry out first line maintenance of the equipment. Second line maintenance is usually contracted to the manufacturer.

c) Facility and Equipment design

Activities in radiotherapy include imaging (simulators and/or CT Scanners), immobilization (mould room facilities) and treatment planning. Spaces common to all activities include office space for physicians and physicists, laboratories, a darkroom, a registration area and a filing room. A physics laboratory with cabinet space to store phantoms, ionization chambers, electrometers, cables and film should be available. If thermoluminescent dosimetry (TLD) and film dosimetry are available, an area should be designed for these activities. The darkroom should be located conveniently near the simulator, external beam therapy and brachytherapy activity rooms. An area should be designated for clerical staff to make bookings and register new patients, sign in patients under treatment and retrieve files for follow-up patients. A file storage area should be provided sufficient for long term storage of documentation. It is preferable to provide air conditioning for the entire facility; however, as a minimum, air conditioning should be provided for the treatment rooms, planning room and the treatment control areas where computers are located.

Facilities for radiation therapy fall into three groups:(1) External beam radiotherapy;(2) Low dose rate brachytherapy (including pulsed dose rate (PDR));(3) High dose rate brachytherapyExternal Beam Therapy

An external beam facility requires examination rooms, a simulator room, a treatment planning room, a mould room, a treatment room (bunker) and waiting areas. The simulator room, treatment planning room and treatment room should be designed in consultation with the manufacturer of the equipment. The requirements for power, air conditioning, monitoring ports and emergency system must be considered. The facility must be isolated from other parts of the hospital to minimize radiation safety

concerns, preferably on the ground floor or basement to provide good structural support for the equipment and omit shielding of the floor where necessary.

Examination rooms

The examination rooms should be in close proximity to the treatment room. The examination rooms should include standard and gynaecological examination tables, a head and neck examination chair, appropriate examination instruments and medical supplies.

Simulator room

The shielding of the simulator room shall be designed according to the recommendations of US National Council on Radiation Protection and Measurements (NCRP) Report No. 151 [6], paying due regard to the requirements of the BSS [1]. The room should be large enough to accommodate the simulator, allowing the full range of motion of the treatment table. A means for securely mounting the patient positioning lasers to the wall at points appropriate for projection of lines through the isocentre should be included in the plans. A means for dimming the room lights should be considered in the design of the room. Adequate space should be planned for cabinetry to store treatment devices and daily used quality assurance equipment. If the immobilization devices are to be fabricated in the simulator room, cabinet space to store supplies for their fabrication will be required. A sink should then be provided in this room. A viewing window should be provided for the control room. Light boxes in the control room and simulator room are useful.

Treatment planning room

The treatment planning room should be located in close proximity to the simulator room, although the two areas do not have to be adjacent. The room should be large enough to house the treatment planning computer with its video monitor, a printer and plotter, a digitizer tablet and other required computer equipment. Space will also be required for supplies of paper and pens or ink for the printer and plotter. An area designed to accommodate an L shaped arrangement of the digitizer tablet and video monitor is more desirable than a linear arrangement with the two devices side by side. Space for light boxes and a high intensity light for viewing CT scans and plane X ray films must be provided. In larger centres, more than one computer video terminal will be required.

Mould room

Space should be planned for a mould room to fabricate custom designed blocks and compensators. Space for tools, a block cutter and counter-top workspace for pouring and mounting the blocks is required. Storage space for supplies of styrofoam, trays and shielding material for custom blocking is necessary. Adequate ventilation should be provided if shielding materials are melted in this area. If immobilization devices are fabricated in the mould room, space for a patient couch will be required. A sink with a refuse trap is required, as plaster of Paris is frequently utilized.

Treatment room

The treatment room shielding should be designed in accordance with the recommendations of NCRP Report No. 151 [6], paying due regard to the requirements of the BSS [1]. The room should be large enough to accommodate the treatment machine, allowing the full range of motion of the treatment table. If total body irradiation (TBI) is planned, a larger treatment room is required. A sign should be posted at the entrance warning of the radiation hazard, in accordance with statutory instrument 62 of 2011. For a 60Co unit, an area radiation monitor safe against a power failure should be visible on entering the room. A means for dimming the room lights should be considered in the design of the room. Adequate space should be planned for cabinetry to store treatment devices, immobilization devices, blocks and daily used quality assurance equipment. A means for secure mounting of patient positioning lasers to the wall at points appropriate for projection of lines through the isocentre should be included in the plans. A maze entrance leading into the room must be designed to provide shielding. Space for a console immediately outside the treatment area overlooking the treatment room door shall be planned. This console area should be large enough to accommodate not only the control console for the unit but also a workspace for the treatment technologist, in addition to space for an intercom and closed circuit

television system. The console area should also accommodate any computer equipment associated with the treatment machine. The layout of the treatment room is illustrated in the figure below:

Fig 1: Layout of an External beam therapy facility

Waiting areas

Separate waiting areas for patients attending clinics and those awaiting treatment should be designed. The clinic waiting area should have space for approximately eight patients for each physician. The treatment waiting area should be adjacent to the treatment room, with space for seating of about twelve people for each machine. There should also be an area provided for patients on stretchers, which should be adjacent to the treatment area, but they should preferably be separated from ambulatory patients. The area should be large enough to accommodate three stretchers. Patients will usually have to remove some of their clothes for treatment. The provision of appropriate changing facilities close to the entrance of the treatment room, and shielded from the view of other patients and visitors, can avoid patients having to undress in the treatment room. This will reduce the time needed for treatment of each patient.Low Dose Rate Brachytherapy

Low dose rate brachytherapy requires a source storage and preparation room, operating room, treatment planning room and patient room. Facility design should incorporate features to avoid transport in elevators of patients containing radioactive sources. Sterilization facilities for applicators will also be required. The sterilization process should be appropriate to prevent damage of the applicators.

Source storage and preparation room

This room should be designed in accordance with the recommendations of NCRP Report No. 151 [6], paying attention to the requirements of the BSS [1] and be provided with a locked door to control access to the radioactive material. A sign should be posted on the door warning of the radiation hazard, in accordance with statutory instrument 62 of 2011. It should contain shielded storage for all sources and have facilities for receiving, preparing, calibrating and returning sources. An area radiation monitor should be visible on entering the room and while preparing the sources. Space for a workbench should be provided. A cabinet for the necessary instruments, equipment, treatment aid and the required documents should also be available. Space for source transportation trolleys should be provided. It may also be necessary to provide storage to allow decay of sources to safe levels.

Operating theatre

If anaesthesia is required for placement of applicators or catheters to contain the radiation sources, an operating room facility and recovery area are required. An X-ray unit, preferably with fluoroscopic capabilities, is desirable in the operating room because it enables the position of the applicator or catheters to be checked, and if necessary repositioned, before the patient leaves the operating suite. In addition, localization X rays (orthogonal or stereo-shifted X rays) required for dose calculation purposes can be taken with this unit. If no X ray unit is in the operating room, these functions must be available elsewhere.

Treatment planning room

Treatment planning for LDR brachytherapy is usually performed on a general TPS for teletherapy and brachytherapy using brachytherapy planning software.

Patient rooms

Each LDR brachytherapy patient must be housed in a separate room. The rooms should be shielded according to the recommendations given in NCRP Report No. 151 [6], paying due attention to the requirements of the BSS [1]. A sign should be posted on the door warning of the radiation hazard in accordance with the requirements of SI-62 of 2011. A list with the maximum duration of daily visits by members of the general public should be posted on the door. If several rooms are required, they should be adjacent to each other. The patient should be attended by nurses with special training in the care of radiation therapy patients. A toilet for each room has added patient convenience but increases the risk of losing sources. A bell connected to the nurses’ station is essential as gynaecological patients need to use bedpans and may not use even common toilets. Storage for a bedside shield and emergency source container should also be provided.

Additional requirements for LDR remote afterloading

Additional requirements for remote afterloading include:(a) Additional floor space and required utilities (dedicated compressed air and power sources);(b) A door interlock or other suitable means to prevent unauthorized access to the patient rooms;(c) An area radiation monitor that is safe against a power failure in the patient rooms.

High Dose Rate Brachytherapy

An HDR brachytherapy facility requires:(a) An operating theatre;(b) A radiographic imaging system;(c) A treatment room;(d) A treatment planning area.NB: Treatment planning for HDR is a separate system from that used for external beam therapy and must be housed in a convenient place for usage of the HDR machine.

Fig 2: Layout of an HDR brachytherapy facilityEquipment Specifications

The equipment needed to perform external beam radiation therapy falls into five main categories:(1) Imaging;(2) Treatment planning;(3) Treatment delivery;(4) Quality assurance;(5) Radiation safety.

Imaging

Imaging systems should include:(a) An image intensifier with a diameter of ≥ 23 cm;(b) Lateral and longitudinal movements of the image intensifier;(c) A maximum vertical source to input screen distance of ≥ 175 cm;(d) A 35 cm × 43 cm cassette film holder, including four cassettes;(e) A TV circuit and monitor TV.

Treatment Planning

GantriesThe gantry should have the following characteristics:(a) Motorization of gantry with isocentric design;(b) A gantry rotation of 0–360°;(c) An X ray focus to isocentre distance of 80–120 cm (depending on the local equipment);(d) An isocentre height above floor level ≤ 130 cm;(e) An isocentre maximum sphere diameter of 3.0 mm (2.0 mm preferred);(f) Control of parameters inside the treatment room.X ray housings and collimatorsThe X ray housing and collimator should meet the following requirements:(a) The X ray tube and housing should be with a rotating anode, even in fluoroscopy. There should be two foci.

(b) The X ray beam should be collimated by a motorized diaphragm with both local and remote control.NB: If a department is equipped with Multileaf Collimators (MLCs) on its accelerators, it is important that the simulator should be equipped to plan for these devices. Some method of displaying the intended leaf positions superimposed on the radiographic image should be provided.(c) The field should be defined by wires, independent of the X-ray beam diaphragm, motorized and with both local and remote control.(d) The projection of the wires should be ≤ 2.5 mm at the isocentre.(e) The collimator rotation limits should be ±100° (manual and/or motorized rotation).(f) The optical distance indication range — source–axis distance (SAD) should be SAD ± 20 cm.(g) The maximum field size at the isocentre should be ≥ 30 cm × 30 cm at 100 cm from the focus (40 cm × 40 cm preferred).(h) The minimum field size at the isocentre should be ≤ 5 cm × 5 cm (3 cm × 3 cm preferred).(i) An asymmetric setting of the jaw positions is desirable.(j) The light/radiation field congruence should be ≤ 2 mm.(k) There should be a transparent shadow tray.Couch tablesCouch tables should meet the following requirements:(a) X ray transparency of the table top;(b) Isocentric rotation limits of ±90°;(c) A patient lateral motion range of ±20 cm;(d) Motorized vertical movement, with a minimum height of ≤ 80 cm and not less than 40 cm below the isocentre, and up to at least 3 cm above the isocentre;(e) A longitudinal range of ≥ 70 cm;(f) Sag of table top of ≤ 5 mm with a patient of 80 kg.Remote control consolesMovement and light controls should be provided together with the appropriate X ray control switches: gantry, collimator, image intensifier and couch.X ray generatorsX ray generators should include:(a) Fluoro/radiography;(b) A 30 kW high frequency generator; otherwise ≥ 50 kW;NB: The shadow tray should duplicate the geometry of the treatment machine and be able to bear the weight of the lead blocks used for shielding during treatment without distorting the isocentric stability.(c) Radiography: 125 kVp and 300 mAs. Fluoroscopy: up to 15 mA.

Computerized treatment planning systems

HARDWAREThe personal computer (PC) should be equipped with:(a) Screen coordinated positioning (joystick, mouse and a light pen);(b) A colour display monitor for high resolution presentation of graphics(matrix ≥ 256 × 256) and multipresentation (text and images).The data input/output (I/O) devices require:(a) A digitizer for image size 40 cm × 50 cm or greater;(b) A resolution better than 0.5 mm;(c) A printer.A plotter should:(a) Be of DIN A3 format or have continuous paper 40 cm wide;(b) Be at least four colour;(c) Have a resolution better than 0.5 mm;(d) Have reproducibility better than 0.5 mm.SOFTWAREIf absolute dose calculations (time) are performed, the system shall provide a detailed list of all corrections (wedges, tray, decay, etc.) and physical constants (gamma factors, half-life, etc.). The minimum requirements are:

(a) For external therapy:(i) 2.5-D7 calculations for 60Co beams;(ii) Fixed source–skin distance (SSD) and isocentric calculations;(iii) Calculation with at least six simultaneous external beams;(iv) Irregular field calculations;(v) Corrections for obliquity and distance;(vi) Correction for tissue inhomogeneity;(vii) Wedge calculation;(viii) Ability to modify contours to accommodate boluses.(b) For brachytherapy:(i) Source position reconstruction from X ray film;(ii) Cs-137, 192Ir and 125I sources;(iii) Correction for source filtration;(iv) Support for the most common gynaecological applicators(Henschke, Fletcher–Suit, Manchester and Delouche, depending on equipment available in the hospital);(v) Calculation for point and line sources, as well as combinations of these;(vi) Source rotation display.(c) For data input:(i) Manually acquired patient contours;(ii) User radiation beam data (possibility for extracting data tables and plotting distributions);(iii) Source position and anatomical landmarks for brachytherapy.(d) For data output:(i) Real size plots.

Linear accelerators and 3-D planning need:(a) Computer tomography image input (e.g. via DICOM3);(b) Three dimensional dose calculations and display algorithms (or at least2.5-D) for high energy photon and electron beams;(c) Combination of photon and electron beams;(d) Combinations of external beams and brachytherapy;(e) Arc therapy treatment planning;(f) Output for customized blocks;(g) Output plots at varying scales;(h) Selection of bolus density;(i) Support for dynamic and automatic wedges (depending on the linacs in use);(j) Support for MLC planning (if available in the hospital).

Treatment Delivery

Specifications for orthovoltage units

Support systems

The ceiling or floor mounted support system for the X ray tube assembly should permit movement in all three orthogonal planes, together with rotation about two orthogonal horizontal axes. If the movements are motorized, provision shall be made for a motion inactuator.Couch tablesThere should be a wheeled patient support table (preferably with height adjustment), and the table surface should be non-absorbent. Control consolesThe control console should include:(a) A dual timer and a timer/ionization chamber or dual ionization chamber dose control system;(b) Selectable kilovoltage settings interlocked to filter interlocks on the treatment head. X ray generators

The X ray generator system should include:(a) A three phase X ray generator with a voltage regulator;(b) A generator to operate at a range of kilovoltages up to about 300 kV.

Specifications for 60Co teletherapy units and their radiation sources

Gantries and treatment headsGantries and treatment heads should have the following characteristics:(a) A gantry motorized with isocentric design;(b) A gantry rotation of 0–360°;(c) A source isocentre distance SAD ≥ 80 cm;(d) An isocentre height above floor level ≤ 130 cm;(e) An isocentre clearance (with devices inserted) ≥ 15 cm;(f) An isocentre maximum sphere ≤ 3.0 mm diameter;(g) Hand-held control of parameters inside the treatment room;(h) Collimator:(i) Collimator jaw indication, either mechanical or electrical;(ii) Collimator rotation at least ±100°, with manual and/or motorized rotation;(i) An optical distance indication range — SAD ± 20 cm, with mechanical backup;(j) Secondary collimators (trimmers) to reduce penumbra;(k) A transparent shadow tray for secondary collimation (blocks) to support blocks up to 20 kg. To allow treatment at any angle with blocks, it shall be possible to fix the blocking tray to the collimator without the use of hand tools. A standard set of blocks shall be supplied. It shall be possible to use blocks and wedges simultaneously. The block tray should be interlocked to the console.

Radiation fieldThe radiation field should have the following characteristics:

(a) Maximum field size at isocentre ≥ 30 cm × 30 cm (50% isodose level)(Section V.7.4);(b) Minimum field size at isocentre ≤ 5 cm × 5 cm (50% isodose level);(c) Symmetry better than ±3%;(d) Uniformity of ±3% over 80% of the field;(e) Light/radiation field congruence ≤ 2 mm;(f) Source diameter ≤ 2.5 cm;(g) Achievable penumbra ≤ 1 cm, either with trimmers or blocks;(h) Output ≥ 1.5 Gy/min at isocentre (at a depth of dmax) for a 10 cm × 10 cm field during the acceptance test;(i) Four wedge angles (15, 30, 45 and 60°) available for 15 cm in the wedged direction and 18 cm in the perpendicular direction. Insertion of wedges must not restrict the use of secondary collimation. The maximum field size covered by the wedge should be specified on the wedge. Wedges shall be fixed for collimator and gantry rotation. It shall be possible to use blocks and wedges simultaneously. Interlocks must be provided so that the operator has to positively select the correct wedge.Couch tablesCouch tables should have the following characteristics:(a) The table top should have a transparent window exceeding the maximumfield size.(b) The limits of the angle of rotation of the top should be ±180°.(c) The isocentric rotation limits should be ±90°.(d) The range of patient lateral motion should be ±20 cm (necessary for treatment of lateral fields without moving the patient, irrespective of the couch, from the initial position). This shall be achieved either by moving the table top laterally or by a combination of isocentric and column rotation.(e) Vertical movement should be motorized, with a minimum height ≤80 cm; not less than 40cm below the isocentre and at least up to 3 cm above the isocentre.(f) The longitudinal range should be ≥ 70 cm.(g) The sag of the table top should be ≤ 5 mm with a patient of 80 kg weight.

Control consoleThe control console should have a general on/off key.

Options and accessories include:(a) A counterweight (or beamstopper – only if the room design is inadequate);(b) Independent head rotation on arm (range: ±90°) (Section V.7.5);(c) A couch table with centred spine section;(d) An area monitor with an acoustic/optical signal of radiation;(e) Three lasers for patient centring (two cross and one sagittal);(f) A 35 cm × 43 cm cassette holder for portal films, including four cassettes;(g) A closed circuit TV8 or window;(h) Immobilization devices for arms, legs and head;(i) A backpointer;(j) Intercommunication with the patient (two stations).

Specifications for Linear Accelerators

Gantries and treatment headsThe gantry and treatment head should have the following characteristics:(a) A gantry motorized with isocentric design;(b) A gantry rotation of ±190º;(c) A source–isocentre distance (SAD) of 100 cm;(d) An isocentre height above floor level of ≤ 135 cm;(e) Isocentre clearance (with devices inserted) ≥ 30 cm;(f) Isocentre maximum sphere ≤ 2.0 mm in diameter;(g) Hand-held control of parameters inside the treatment room;(h) A collimator with:(i) Collimator jaw indication either mechanical or electrical with mechanical backup;(ii) Collimator rotation at least ±100° with motorized rotation;(i) Optical distance indication range: SAD ± 20 cm, with mechanical backup;(j) A transparent shadow tray for secondary collimation (blocks) to support blocks up to 20kg. To allow treatment at any angle with blocks, it shall be possible to fix the blocking tray to the collimator without use of hand tools. A standard set of blocks shall be supplied. It shall be possible to use blocks and wedges simultaneously. Photon radiation fieldThe photon radiation field should have the following characteristics:(a) The single photon energy should be equivalent to 6 MV (b) The maximum field size at the isocentre should be ≥ 40 cm × 40 cm (50% isodose level).(c) The minimum field size at the isocentre should be ≤ 4 cm × 4 cm (50% isodose level) (3cm × 3 cm is preferred).(d) Symmetry should be to better than ±3%.(e) The uniformity should be to ±3% over 80% of the field.(f) The light/radiation field congruence should be ≤ 2 mm.(g) A penumbra ≤ 8 mm should be achievable.(h) The output should be variable from 0.5 Gy/min to more than 3 Gy/min at the isocentre (at a depth of dmax) for a 10 cm × 10 cm field.(i) Nominal wedge angles of 15, 30, 45 and 60° must be available. An extended set of wedge angles (achievable as a single beam) would be preferred. The wedged field size should be at least 20 cm (w) × 30 cm.(Coverage of the full field size in the unwedged direction is preferred.) Insertion of wedges must not restrict the use of secondary collimation.The maximum field size covered by the wedge must be interlocked to the machine. Wedges shall be fixed for rotation of collimator and gantry. It shall be possible to use blocks and wedges simultaneously. Ideally, wedges should be selectable from outside the treatment room either using a motorized wedge or a ‘dynamic wedge’ created by jaw movements. Dose monitoringThe dose monitoring equipment should include the following:(a) A dual ionization chamber system with independently monitored high voltage supply;(b) Interlocks to detect dose rate differences between the two channels;(c) A high dose rate interlock to prevent an excess dose rate;(d) An independent backup timer. Couch tables

For the couch table:(a) The table top should have a transparent window up to the maximum field size.(b) The angular rotation limits of the table top should be ±180º.(c) The isocentric rotation limits should be ±90º.(d) The lateral motion range of the patient should be ±20 cm (necessary for treatment of lateral fields without moving the patient, from initial positioning with respect to the couch). This shall be achieved either by moving the table top laterally or by a combination of isocentric and column rotations.(e) Vertical movement should be motorized, with a minimum height of ≤ 80 cm but not less than 40 cm below the isocentre, and at least up to 3 cm above the isocentre.(f) The longitudinal range should be ≥ 70 cm.(g) Table top sag should be ≤ 5 mm with a patient of 80 kg (≤ 3 mm is preferred).

Control consolesControl consoles should have a general on/off key.

Options and accessories should include:(a) A counterweight or a beamstopper;(b) A couch table with a centred spine section;(c) An acoustic or optical signal for the radiation dose rate;(d) Three lasers for patient centering;(e) A 35 cm × 43 cm cassette holder for portal films, including four cassettes;(f) A closed circuit TV;(g) Immobilization devices for arms, legs and head;(h) A backpointer — preferably optical;(i) An intercommunication device with the patient (two stations);(j) Connectivity to a Record and Verify (R&V) system;(k) The accelerator should have protection to avoid collisions with the patient where this could be hazardous to the patient, and collisions with other parts of the accelerator where this could lead to damage or interruption of dynamic treatments.

Specification of Equipment For Remote LDR And HDR Afterloading Brachytherapy

o Equipment for Low Dose Rate Afterloading Brachytherapy

Ir-192 source loading and cutting devices Source storage and transport containers (for remote LDR this should be part of the

equipment) within the department Source handling instruments and accessories (in source preparation room and patient loading

room) An area radiation monitor in treatment room with a light signal outside the entrance door, safe

against power failure A portable radiation monitor Highly recommended: an area radiation monitor with an audio signal at the entrance to the

treatment room. An emergency container and emergency source handling instruments in the treatment room. Radioactive waste storage. Equipment for source/applicator localization and identification (e.g. X ray equipment) Dummy sources for applicator localization in patients A patient couch adapted for LDR brachytherapy applications: gynaecological, head and neck,

bronchial (leg rests, film cassette holders, anaesthesia requirements, etc.) A device for fixation of a connector between the transportation applicator tubes to the patient.

(Remote LDR only) A set of applicators for intracavitary (e.g. Henschke, Fletcher–Suit, Manchester or Delouche

type) and interstitial treatments. A radiation protection barrier for source loading in patients and for patient care.(Manual LDR

only) Portable radiation protection barriers in the case of insufficient protection in patient ward walls

and doors.

o The following features are required:(a) A source positioning reproducibility to ±1 mm;(b) Automatic source retraction in the case of a power failure;(c) An intermediate source storage container;(d) A minimum of three source channels for intracavitary and endoluminal treatments (but four source channels are highly desirable);(e) A remote nurse alarm station.

Minimum Equipment Requirements for HDR Brachytherapy

a) An area radiation monitor in the treatment room, connected to the door interlock with an audio signal safe against power failure and independent of treatment equipment;

(b) A portable radiation monitor instrument at the entrance of the treatment room; (c) Highly recommended: an area radiation monitor with an audio signal at the entrance to the treatment room; (d) Emergency container and emergency source handling devices at the entrance of the treatment room door (e) Equipment for applicator localization and identification (e.g. an X-ray unit); (f) Dummy sources for applicator localization; (g) A treatment couch adapted for HDR brachytherapy: gynaecological and bronchial equipment (leg rests film cassette holders, anaesthesia requirements, etc.); (h) A set of applicators for intracavitary (e.g. Henschke, Fletcher–Suit, Manchester or Delouche type) and endoluminal treatments;

(i) film cassette holders, anaesthesia requirements, etc.);(ii) A device for applicator fixation to the treatment couch.

Minimum Equipment for Quality Assurance programmes in Brachytherapy

A well type ionization chamber or an isotope calibrator with source holding inserts, calibrated at a standards laboratory for the clinical sources available

If Cs-137 sources are not available, a long lived reference source for checking the stability of the well chamber

A facility to verify source homogeneity and source position (requires access to film development)

A barometer (minimum scale: 1 mbar or 0.5 mmHg), preferably of aneroid type or digital, calibrated or compared at a standards laboratory (if not available in external radiotherapy)

Calipers and a metal ruler

Quality Control Programmes

(1) External beam treatments

Quality Control of Orthovoltage Units

Quality Control of 60co Units

Frequency Procedure ToleranceDaily Output constancy

Interlocks and warningsMechanical fixturesFilter interlock

±5%FunctionalFunctionalFunctional

Monthly Output measurementTimer end errorTimer accuracyBackup timerTimer response to power failureFilter interlocksMechanical fixturesMonitor chamber linearityCoincidence of light beam and X ray beamHVL constancy

±3%±0.01 min±2% or ±0.02FunctionalFunctionalFunctionalFunctional±2%

±5 mm±5%

Annually Field uniformityHalf-value layerApplicator factors

±5%±10%±3%

Frequency Procedure ToleranceDaily Safety

Door interlockRadiation room monitorAudiovisual monitorMechanicalLocalizing lasersOptical distance indicator (ODI)

FunctionalFunctionalFunctional

2 mm2 mm

Weekly Check of source positioning 3 mmMonthly Dosimetry

Output constancyMechanical checksCoincidence of light and radiation fieldsField size indicator (collimator setting)Gantry and collimator angle indicatorCross-hair centringLatching of wedges and traysSafety interlocksEmergency off switchesWedge interlocks

2%

3 mm

2 mm1º2 mmFunctional

FunctionalFunctional

Annually DosimetryOutput constancy traceable to SSDLField size dependence of output constancyCentral axis dosimetry parameter constancy (PDD/TAR)cTransmission factor constancy for all standard accessoriesWedge transmission factor constancyTimer linearity and errorOutput constancy versus gantry angleBeam uniformity versus gantry angleOff-axis point measurements with and without wedgesSafety interlocksFollow test procedures of manufacturer

2%

2%

2%

2%

2%1%

2%3%

3%

Functional

Mechanical checksCollimator rotation isocentre

Gantry rotation isocentre

Couch rotation isocentre

Coincidence of collimator, gantry and couch axes with isocentreCoincidence of radiation and mechanical isocentresTable top sag with 80 kg mass evenly distributedVertical travel of tableField intensity of light

2 mmdiameter3 mmdiameter2 mmdiameter2 mmdiameter2 mmdiameter

5 mm2 mmFunctional

The tolerances listed should be interpreted to mean that if a parameter either exceeds the tabulated value (e.g., the measured isocentre under gantry rotation exceeds 2 mm diameter) or the change in the parameter exceeds the nominal value (e.g., the output changes by more than 2%), then an action is required. The distinction is emphasized by the use of the term ‘constancy’ for the latter case. Moreover, for constancy, per cent values are plus/minus the deviation of the parameter with respect to its nominal value; distances are referenced to the isocentre or nominal SSD.

Quality Control of Linear Accelerators without Electron Beams

Frequency Procedure ToleranceDaily Dosimetry

Output constancySafetyDoor interlockAudiovisual monitorMechanicalLocalizing lasersODI

3%

FunctionalFunctional

2 mm2 mm

Monthly DosimetryOutput constancy with field instrument, with appropriatecorrectionsBackup monitor constancyCentral axis dosimetry parameter constancy(e.g. PDD and TAR)Beam flatness constancyBeam symmetryMechanical checksCoincidence of light and radiation fieldsField size indicator (collimator setting)Field light intensityJaw symmetryGantry and collimator angle indicatorCross-hair centringWedge position

Tray positionTreatment couch position indicatorsLatching of wedges and blocking traySafety interlocksEmergency off switchesWedge interlocks

2%2%

2%3%3%

2 mm or 1% on a side2 mmFunctional2 mm1º2 mm diameter2 mm or 2%change in transmission factor2 mm2 mm/1º Functional

FunctionalFunctional

Annually DosimetryOutput calibration traceable to SSDLField size dependence of output constancyTransmission factor constancy for all standard accessoriesOff-axis factor constancyWedge transmission factor constancy (including depthand field size dependence)Monitor chamber linearityOutput constancy versus gantry angleBeam uniformity constancy versus gantry angleArc modeOff-axis point measurements with and without wedgesSafety interlocksFollow test procedures of manufacturerMechanical checksCollimator rotation isocentreGantry rotation isocentreCouch rotation isocentreCoincidence of collimator, gantry and couch axes with isocentreCoincidence of radiation and mechanical isocentresTable top sag with 80 kg mass evenly distributedVertical travel of table

2%

2%

2%2%

2%1%2%

2%As specified

3%

Functional

2 mm diameter2 mm diameter2 mm diameter

2 mm diameter

2 mm diameter

2 mm2 mm

TthThe The tolerances listed should be interpreted to mean that if a parameter either exceeds the tabulated value (e.g., the measured isocentre under gantry rotation exceeds 2 mm diameter) or the change in the parameter exceeds the nominal value (e.g., the output changes by more than 2%), then an action is required. The distinction is emphasized by the use of the term ‘constancy’ for the latter case. Moreover, for constancy, per cent values are plus/minus the deviation of the parameter with respect to its nominal value; distances are referenced to the isocentre or nominal SSD.

Quality Control of Linear Accelerator Electron Beams

These tests are those that are additional to those given in the previous table, for accelerators equipped with an electron beam. All these procedures should be carried out during commissioning. Appropriate tests should be performed following any repair of the teletherapy unit.The tolerances listed should be interpreted to mean that if a parameter either exceeds the tabulated value (e.g., the measured isocentre under gantry rotation exceeds 2 mm diameter) or the change in the parameter exceeds the nominal value (e.g., the output changes by more than 2%), then an action is required. The distinction is emphasized by the use of the term ‘constancy’ for the latter case. Moreover, for constancy, per cent values are plus/minus the deviation of the parameter with respect to its nominal value; distances are referenced to the isocentre or nominal SSD.

Quality Control of Simulators

Frequency Procedure ToleranceDaily Dosimetry

Output constancy with constancy meter±3%

Monthly DosimetryOutput constancy with fieldinstrument, with appropriate corrections

Central axis dosimetry parameter constancy (PDD)Beam flatness constancyBeam symmetryMechanical checksApplicator positionSafety interlocksElectron cone interlocks

2%

2 mm attherapeutic depth3%

3%

2 mmAnnually Field u

Half-value layerApplicator factors

±5%±10%±3%

The tolerances mean that the parameter exceeds the tabulated value (e.g., the measured isocentre under gantry rotation exceeds 2 mm diameter).

Frequency Procedure ToleranceDaily Localizing lasers

ODI2 mm2 mm

Monthly Field size indicatorGantry/collimator angle indicatorsCross-hair centringFocal spot-axis indicatorFluoroscopic image qualityEmergency/collision avoidanceCoincidence of light and radiation fieldsFilm processor sensitometry

2 mm1º2 mm2 mmBaselineFunctional

2 mm or 1%Baseline

Annually Mechanical checksCollimator rotation isocentreGantry rotation isocentreCouch rotation isocentreCoincidence of collimator, gantry, couch axes and isocentreTable top sag with 80 kg mass evenly distributedVertical travel of couchRadiographic checksExposure rateTable top exposure with fluoroscopykVp and mAs calibrationHigh and low contrast resolutions

2 mm diameter3 mm diameter2 mm diameter

2 mm diameter

5 mm2 mm

BaselineBaselineBaselineBaseline

Quality Control for Treatment Planning Systems and Treatment Time Calculations

a Per cent differences between calculations of the computer TPS and measurements (or independent calculations).b In the region of high dose gradients, the distance between isodose lines is more appropriate than the percentage difference. In addition, less accuracy may be obtained near the end of single sources.c These limits refer to a comparison of dose calculations at commissioning with the same calculations subsequently.d These limits refer to a comparison of calculations with measurements in a water tank.

2) Quality Control of Remote Afterloading Brachytherapy Units

Frequency Procedure ToleranceCommissioningand following

software updates

Understand algorithmSingle field or source isodose distributions Treatment time calculations includinginhomogeneity corrections whereappropriateTest casesI/O system

Functional2%a or 2 mmb

2% or 5%if includinginhomogeneities

2% or 2 mm1 mm

Daily I/O devices 1 mm

Monthly Check sumSubset of reference quality assurance test set(when check sums not available)I/O system

No change

2% or 2 mmc

1 mm

Annually Treatment time calculationsReference quality assurance test setI/O system

2%2% or 2 mmd

1 mm

NB: When changing a source, calibrate both the new and the old sources to establish and document the reproducibility of the calibration method.

Quality Control Tests for Brachytherapy Sources

Type of Source Test Frequency ToleranceLong half-life:description

Physical/chemical form Source encapsulation Radionuclide distribution and source uniformityLocation of radionuclide in encapsulation

II

I

I

DD

D

DLong half-life:calibration

Mean of batch Deviation from meanVerification of calibration

II E

3%5%, Da

Short half-life:description

Physical/chemical form Source encapsulation

II

DD

Mean of batch Deviation from meanb Radionuclide distribution and source uniformity

E

E

3%5%

Vc

Key: I, initial purchase; D, documented; E, at every use. a Visual check of source colour code or measurement in a calibrator. b For short half-life sources, this may not always be practical. c V, visual check, autoradiograph or ionometric check.

Frequency Test ToleranceEach treatment day

Room safety door interlocks, lights and alarmsConsole functions, switches, batteries and printer

Visual inspection of source guides

Verify accuracy of ribbon preparation

Functional

Functional

Free of kinks and firmly attached

Autoradiograph

Weekly Accuracy of source and dummy loading(dummies used for spacing and/orsimulation/verification)

Source positioning

1 mm

1 mmAt each sourcechange or quarterly

Calibrationa Timer function Check accuracy of source guides and connectors

Mechanical integrity of applicators (by X ray if appropriate)

3%1%

1 mm

Functional

Annually Dose calculation algorithm (at least one standard source configuration for each isotope)Simulate emergency conditionsVerify source inventory

3%, 1 mm

Quality Control Tests for Brachytherapy Applicators

Type of applicator

Test Frequency Tolerance

Intracavitary Source location

Coincidence of dummy and active sources

Location of shields

I, yearly

Ia

Ib

D

1mm

D

Interstitial Coincidence of dummy and active sources I,E

1mm

Key: I, initial use or following malfunction and repairs; D, documented and correction applied or noted in report of measurement, when appropriate; E, as a minimum, a visual inspection to verify that the dummy sources fairly represent the active source distribution a To reduce exposure of personnel, the dummy source location may be checked instead of the active source if it is established that the dummy and active source locations are coincident b The location of shields should be verified by radiograph before first use. Before every use, the applicator may be shaken to listen for loose parts.

Quality Control Tests for Brachytherapy Source Calibrators

Instrument type Test Frequency ToleranceWell type ionizationchamber

Standards laboratory calibration Precision Linearity

Collection efficiency Geometrical/length dependence Energy dependence Source wall dependence Venting Redundancy check Leakage

I, Sa

II, every two yearsIIIIIEE

D2%1%

1%DDDD2%D

In-air calibrationchamber and external

SSDL calibration Accuracy of source chamber distance

I, Sa

Annually, S

D

1%, D

source holder RedundancyE D

Key: I, initial use or following malfunction and repairs a; S, isotope/source specification;D, documented and correction applied or noted in report of measurement,when appropriate; E, at each use (measurement sequence) or ongoing evaluation.

(3) Measurement equipment;

Basic Equipment recommended for Dosimetry in External Radiation Therapy

Type of InstallationBasic Equipment Co-60 Linac,

photonsonly

Linacwithelectrons

An ionization chamber of Farmer type, of 0.6 cm3 volume approximately, with plastic walls (robust), a Co-60 buildup cap, a 10 m long cable and a 10 m long extension cable with connectors calibrated at a standards laboratory.

× × ×

An ionization chamber of Farmer type, of 0.6cm3 volume approximately, with graphite walls, a Co-60 buildup cap and a 10 m long cable, calibrated at a standards laboratory in terms of absorbed dose to water.

× × ×

A cylindrical ionization chamber, of 0.1–0.3 cm3 volume approximately, with a 10 m long cable (maximum electrode diameter: 1 mm)

× × ×

A radioactive source for checking the stability of the cylindrical ionization chamber

× × ×

A plane-parallel ionization chamber for electrons (minimum width of guard ring: 4mm).

×

An electrometer compatible with the chambers above and calibrated or compared at a standards laboratory

× × ×

An additional electrometer with varying voltage bias (V1/V2 ratio equal to or greater than 3), and the possibility to reverse the polarity

× ×

A water phantom for calibration and checks, of volume 20 ×20 × 10 cm3 approximately, with PMMA walls, including a holder for ionization chambers

× ×

A water phantom for calibration, of 30 × 40 × 40 cm3 volume approximately, with PMMA walls, including a holder for ion chambers with manual steps or an automatic system to vary the position of the chamber

× ×

A plastic slab phantom for verification of field size and coincidence of radiation and light

× × ×

field. Used also for output verification, with holes for the chambers, and preferably TLDA barometer (minimum scale 1 mbar or hPa, or 0.5 mmHg),preferably of aneroid type or digital, calibrated or compared at a standards laboratory

× × ×

A thermometer (minimum scale: 0.25°C), calibrated or compared at a standards laboratory

× × ×

A densitometer to measure the optical density (OD) of X ray films, with an automatic reader and coordinate system. An OD calibration film strip for checking of the instrument OD scale. Requires having access to film development

× × ×

A radiation field analyser to measure isodose distributions, of 50 × 50 × 40 cm3 volume approximately, with a water tank, a phantom trolley with vertical movement and a water pump

× ×

All chamber models and electrometers must be included in IAEA dosimetry publications [1

Additional equipment includes but is not limited to:

1) A TLD system (both relative dosimetry and in vivo) 2) An array of diodes or ion chambers for daily quality assurance checks3) A precision water level 4) Calipers and a metal ruler 5) A multimeter (volt, ohm)

Additional Equipment for Low Energy X Ray Dosimetry

Equipment 50 kV or less

50-100kV

Grenz ray chamber ×Ionization chamber ×Plastic phantom ×

Quality Control of Measurement Equipment

Instrument type Test Frequency Tolerancea

Local standardb SSDL calibrationLinearityVentingExtra-cameral signal (stem effect)LeakageRedundancy checkd

RecombinationCollecting potential

2ac

2ac

2ac

IEEIE

D0.5%D

0.5%0.1%2%DD

Field instruments

Local standard comparisonLinearityVentingExtra-cameral signal

2a2a2a2a

1%DDD

LeakageRecombinationCollecting potential

EIE

0.1%DD

Local Output check

standard comparison M 1%

Ion chamber Linearity 1a DFilm Extra-cameral signal

Dose responseDensitometer linearityProcessor uniformity/reproducbilityCalibration

IB1a

EE

1%DD

DD

TLD Linearity I D

Accessories Thermometer calibrationBarometer calibrationLinear rule calibration

I3 monthsI

0.1°C1 mmHg0.3

Key: I, initial use for each mode used or following malfunction and repairs; E, each use (measurement sequence) or ongoing evaluation; B, each batch or box at the appropriate energy (the position of the dosimeter element should also be considered); D, documented and correction applied or noted in report of measurement; M, monthly; a, annually; 2a, once every two yearsa Per cent values are plus/minus the deviation of the parameter with respect to the nominal value, and distances are referred to the isocentre or nominal SSD.c Without a redundancy programme, this may be inadequate.

ANNEX 11 : REGULATORY GUIDE –TRANSPORT OF SOURCES

RADIATION PROTECTION AUTHORITY OF ZIMBABWE

RADIATION PROTECTION ACT (CHAPTER 15:15)

TRANSPORT GUIDE1. Regulatory Requirements

Requirements for the transport and transit of radioactive material should be applied in addition to the following regulations:

- Radiation Protection Act [Chapter 15:15] of 2004- Statutory Instrument 62 of 2011, Radiation Protection (Safety

and Security of Radiation Sources) Regulations;- IAEA Regulations for the Safe Transport of Radioactive

Material (SSR-6) [2012 Edition]

2. Licensing requirements Obtain and submit a duly completed Application for Authorization to Transport/Transit Radiation devices/materials form. (the form can be downloaded from the RPAZ website: www.rpaz.co.zw or collected at our offices) together with requirements set out in the RPAZ requirement: Minimum requirements for authorization to transport radioactive material within or outside Zimbabwe and to transit through Zimbabwe.

3. Exemption provisionsThese provisions shall not be applied to radioactive and nuclear material if:

they are transported within the site boundaries in order to be utilised or managed on the basis of a license and/or permit issued under Radiation Protection Act [Chapter 15:15]

1 McCaw DriveAvondaleBox A1710AvondaleHarareZimbabwe

Phone: +263 4 335627+263 4 335683

Email: officialmail@rpaz.co.zwWebsite: www.rpaz.co.zw

they are mounted to a transport conveyance; they are implanted or introduced into humans or animals for

medical or scientific purposes; they are added in consumer products lawfully offered for sale; Natural material and ores containing naturally occurring

radionuclides which are either in their natural state, or have only been processed for purposes other than for extraction of the radionuclides, and which are not intended to be processed for use of these radionuclides, provided the activity concentration of the material does not exceed 10 times the exempt activity concentration values

4. ResponsibilitiesAny person or organization involved in the transport of radioactive material should comply with the IAEA Regulations for the Safe transport of Radioactive Material (SSR-6), the Minimum requirements for authorization to transport radioactive material within or outside Zimbabwe and to transit through Zimbabwe and the requirements of this guide. Authorisation from RPAZ shall be sought by either the consignor, the carrier or the consignee prior to initiating transport of the radioactive material. (a) Consignor’s responsibilities

The Consignor shall ascertain that: packaging and labelling of radioactive material and

consignments for transport is being done according to the regulations and requirements in this guide.

packages containing radioactive material are safe to handle transport documentation as required by this guide are in order

and are available for the required authorities.

(b) Carrier’s responsibilitiesThe carrier has the responsibility to:

verify that the relevant documentation has been provided with the package and is consistent with the contents

ensure that the transport, handling, loading/unloading, interim storage and stowing conditions are appropriate for the type of package and radioactive material based on the information available on the labels and transport documentation

be familiar with emergency procedures and be able to intervene in the event of an incident while loading/unloading, transporting or storage of a package.

follow instructions provided in the transport documentation by the Consignor pertaining to handling, transport, loading/unloading, stowage, any restrictions and emergency arrangements specific to the package or consignment.

(b) Consignee’s responsibilities

The Consignee should: verify upon receipt that the package is in good condition and

safety aspects have not been compromised ensure that the appropriate transport documentation has

been delivered along with the package

5. DocumentationThe documentation for transport of radioactive material should be a detailed description of the contents of the consignment, including the following information:

The UN number assigned to the material preceded by the letters “UN”.

The proper shipping name The UN class number “7”. The name or symbol of each radionuclide or, for mixtures of

radionuclides, an appropriate general description or a list of the most restrictive nuclides.

Special form certificate - A description of the physical and chemical form of the material, or a notation that the material is special form radioactive material or low dispersible radioactive material.

The maximum activity of the radioactive contents during transport expressed in units of becquerels (Bq)

For fissile material, the mass of fissile material (or mass of each fissile nuclide for mixtures when appropriate) in units of grams (g), or appropriate multiples thereof, may be used in place of activity

The category of the package, i.e. I-WHITE, II-YELLOW, III-YELLOW.

The Transport Index (categories II-YELLOW and III-YELLOW only). (i) For consignments including fissile material, the Criticality Safety Index (CSI).

The identification mark for each competent authority approval certificate (special form radioactive material, low dispersible radioactive material, special arrangement, package design or shipment) applicable to the consignment

number of packages supplementary information required for carriers (for example,

additional handling requirements, emergency arrangements, restrictions on loading)

6. Radiation Monitoring All workers directly involved in the transport of a package containing radioactive material shall receive monitoring from a Dosimetry service provider acknowledged by RPAZ.

7. Training

Workers involved in the transport of radioactive material require training concerning the radiological risks in their work and how they can minimize these risks in all circumstances.Such training shall include

a) general awareness/familiarization training on nature of radiological risk, knowledge of the nature of ionizing radiation, the effects of ionizing radiation and its measurement, as appropriate

b) a description of the type and categories of radioactive material

c) labelling, marking, placarding, packaging and segregation requirements

d) a description of the purpose and content of the radioactive material transport document

e) specific protective measures to be undertaken in the event of an accident

f) the use of specific equipment g) Methods and procedures for accident avoidance, such as

proper use of package handling equipment and appropriate methods of stowage of radioactive material

h) Available emergency response information including established procedures and how to make use of them

i) General dangers presented by the categories of radioactive material they are dealing with and how to prevent exposure to those hazards, including, if appropriate, the use of personal protective clothing and equipment; and

j) Immediate procedures to be followed in the event of an unintentional release of radioactive material.

The training should be seen as a continuous commitment throughout employment and involves initial training and refresher courses at appropriate intervals. The effectiveness of the training should be periodically checked.

Only appropriately trained persons should be engaged in the transport of radioactive material. The jobs and the associated duties and responsibilities should be clearly indicated in the descriptions of the organizations of the consignor, the carrier and the consignee.

8. Record KeepingRecords of activities involving the radioactive material shall be kept by the authorized person/ organization. Records kept should include records of all safety training undertaken and records of measurements taken during each voyage. The main purposes of the records are:(a) To provide to the competent authority or the regulatory body evidence of the appropriate qualifications of all persons whose

duties have a bearing on safety, and evidence of the required authorizations;(b) To provide documentation that can be used in reviews of the training programme to enable the necessary corrective actions to be taken.

9.Requirements before each shipment Before each shipment of any package, the following requirements shall be fulfilled:

i) Transport of other goods Additional items must not be included within a package containing radioactive material. A package shall not contain any items other than those that are necessary for the use of the radioactive material.

ii) Consignments shall be segregated from other dangerous goods during transport in compliance with the relevant transport regulations for dangerous goods of each of the countries through or into which the materials will be transported, and, where applicable, with the regulations of the cognizant transport organizations.

The purpose of this requirement is to prevent radioactive contamination of other goods.

iii) Transport and storage in transit Workers in regularly occupied working areas should be

segregated by appropriate distances, calculated such that the dose to which the worker might be exposed to does not exceed 5 mSv averaged over a year.

Similarly, areas where the public has regular access shall be segregated by distances calculated such that the dose to which members of the public might be exposed to does not exceed 1 mSv averaged over a year.

Radioactive material shall be kept separate from undeveloped photographic film by distances calculated such that the consignment of photographic films is not exposed to more than 0.1 mSv for the overall duration of the transport process.

iv) Stowage during transport Consignments shall be securely stowed. This can be achieved using structural supports to restrain the package and prevent movement during routine transport. Proper retention may prevent packages from tumbling and falling off resulting in damage or even loss.

v) TransitDuring transit there should be no unloading or entering into the enclosed area of a vehicle. If the vehicle is being held in the carrier’s compound for any period it should be parked in an area where access is controlled and where people are not likely to remain in close proximity for an extended period. If maintenance work is required to be done on the vehicle for an extended period, then arrangements should be made with the consignor or the consignee to ensure adequate radiation protection, for example by providing extra shielding and radiation monitoring

10. Special arrangement Consignments for which conformity with the other provisions of the Transport Regulations (SSR-6) is impracticable shall not be transported except under special arrangement. Provided RPAZ is satisfied that conformity with the other provisions of the Regulations (SSR-6) is impracticable and that the requisite standards of safety established by these Regulations have been demonstrated through means alternative to the other provisions, then RPAZ may approve special arrangement transport operations for single or a planned series of multiple consignments. The overall level of safety in transport shall be at least equivalent to that which would be provided if all the applicable requirements had been met. For consignments of this type, multilateral approval shall be required.

11. Determination of transport index The Transport Index (TI) for a package, shall be the number derived in accordance with the following procedure:

(a) Determine the maximum radiation level in units of millisieverts per hour (mSv/h) at a distance of 1 m from the external surfaces of the package, The value determined shall be multiplied by 100 and the resulting number is the TI.

(b) For uranium and thorium ores and their concentrates, the maximum radiation level at any point 1 m from the external surface of the load may be taken as:

(i)0.4 mSv/h for ores and physical concentrates of uranium and thorium;(ii)0.3 mSv/h for chemical concentrates of thorium;(iii)0.02 mSv/h for chemical concentrates of uranium, other than uranium hexafluoride.

Limits on transport index, criticality safety index and radiation levels for packages -The TI of any package shall not exceed 10

-The maximum radiation level at any point on the external surface of a package shall not exceed 2 mSv/h.-The maximum radiation level at any point on the external surface of a package under exclusive use shall not exceed 10 mSv/h.

12. Marking, Labelling and PlacardingRadioactive material shall be assigned to one of the UN numbers specified in Table 1, depending on:-the activity level of the radionuclides contained in a package, -the fissile or non-fissile properties of these radionuclides, -the type of package to be presented for transport, and -the nature or form of the contents of the package, or special arrangements governing the transport operation

Marking

1. Each package shall be legibly and durably marked on the outside of the packaging with an identification of either the Consignor or Consignee, or both.

2. Each package and overpack shall be legibly and durably marked on the outside with the UN marking. Additionally, each overpack shall be legibly and durably marked with the word “OVERPACK”.

3. Each package of gross mass exceeding 50 kg shall have its permissible gross mass legibly and durably marked on the outside of the packaging.

4. Each package shall be legibly and durably marked on the outside of the packaging with an identification of either the consignor or consignee, or both.

Labelling 1. Each package shall bear the labels which conform to the

models in Figs 1, 2, or 3 2. Any labels which do not relate to the contents shall be

removed or covered. 3. The labels shall be affixed to two opposite sides of the outside

of a package or on the outside of all four sides of a freight container or tank.

Placarding 1. Large freight containers and vehicles carrying packages shall

bear four placards which conform to the model given in Fig. 4. 2. The placards shall be affixed in a vertical orientation to each

side wall and to each end wall of the large freight container or vehicle. Any placards which do not relate to the contents shall be removed.

3. Instead of using both labels and placards, it is permitted as an alternative to use enlarged labels only, where appropriate

Appendix 1: Labels and PlacardsFig 1. : White 1 label

Fig 2. : Yellow II label

Fig 3. : Yellow III label

Fig 4. : Placard

Appendix 2: Table of UN numbers

Table 1: