radiological council annual report 2005...radiological council 2005 annual report radiation health...

REPORT OF THE

RADIOLOGICAL COUNCIL

for the year ended

31 December 2005

TABLE OF CONTENTS

CHAIRMAN’S REVIEW I

RADIATION SAFETY ACT 1975 – 2004 1

STATUTORY RESPONSIBILITIES OF THE COUNCIL 1

MEMBERSHIP OF THE COUNCIL 1

ADVISORY COMMITTEES 2

ADMINISTRATIVE SUPPORT 2

STATE ELECTORAL ACT 3

STATE RECORDS ACT 3

THE RADIOLOGICAL COUNCIL WEBSITE 3

REGISTRATIONS, LICENCES AND TEMPORARY PERMITS 3

QUALIFICATIONS AND TRAINING OF RADIATION USERS 3

CHANGES TO LEGISLATION 4

RADIATION INCIDENTS 4

PROSECUTIONS 11

MEDICAL AND RELATED RADIATION MATTERS 12

Compliance Testing 12

Compliance Testing Working Group 12

Regulation of Medical Radiation Technologists 12

Nurse Practitioners 13

Approvals for Exposure to Radiation for Human Subjects in Medical Research 14

Radiological Council 2005 Annual Report

INDUSTRIAL, ENVIRONMENTAL AND MINING RADIATION 16

Industrial Compliance Testing 16

Standards for Council Examinations 16

MISCELLANEOUS 16

National Directory for Radiation Protection 16

Personal Radiation Monitoring Services 16

APPENDIX 1: REGISTRATION AND LICENSING 18

APPENDIX 2: LICENCE PREREQUISITES 20

ATTACHMENT 1: RADIOLOGICAL COUNCIL 21

ATTACHMENT 2: LEGISLATION AMENDMENTS 22

ATTACHMENT 3: COMPLIANCE TESTING 23

ATTACHMENT 4: INDUSTRIAL RADIATION SAFETY EXAMINATIONS 24

ATTACHMENT 5: EQUIPMENT AND SEALED SOLID SOURCES REGISTERED 25

ATTACHMENT 6: LICENCES AND REGISTRATIONS 27

ABBREVIATIONS 31


Page 30

A B Purpose 5 16 Service of X-ray Equipment - Analytical 5 10 Service of X-ray Equipment - Dental

25 53 Service of X-ray Equipment - Diagnostic 7 25 Service of X-ray Equipment - Diagnostic (Extended) 1 2 Service of X-ray Equipment - High Energy

Therapeutic 3 8 Service of X-ray Equipment - Industrial NDT 0 2 Service of X-ray Equipment - Intraoral 4 15 Service of X-ray Equipment - Linear Accelerators 6 13 Service of X-ray Equipment - Other 4 9 Special Purpose Enclosed X-ray Equipment 0 1 Static Detection 1 1 Static Electricity Measurement 1 1 Static Elimination 1 5 Storage 9 26 Transilluminators

26 63 Transport 1 1 X-ray Analysis 1 2 X-ray Analysis (Research)

19 54 X-ray Analysis - Use 40 101 X-ray Analysis - Use and Service (Restricted)

CHAIRMAN’S REVIEW

I have great pleasure in presenting the Annual Report of the Radiological Council of Western Australia for the year 2005.

The year saw a diverse range of issues requiring Council attention that are described fully in the body of the report.

This year the Council spent considerable time on matters associated with research projects involving the use of radiation from tertiary institutions. In association with the relevant Ethics Committees of

these institutions, no effort has been spared to ensure that such projects are conducted with commensurate safety to participants in the process of achieving a benefit for the community.

The growth in the use of lasers for industry, medicine and entertainment observed in previous years continued during 2005. Many of the lasers used in these applications have the potential to cause injury including skin burns and permanent eye damage if improperly used. Council’s laser safety examination was reviewed during 2005 to ensure it remains focussed on the safety issues associated with the wide application of these lasers. This year Council also considered a new category of device, intense pulsed light devices (IPL), used for cosmetic purposes. These devices although not lasers, have similar safety issues and applications as some medical lasers and are therefore considered with this class of equipment.

Council’s programme for periodic compliance testing of medical, dental and chiropractic diagnostic x-ray equipment completed its 9th year. This programme has been very successful over the years and has become crucial in ensuring safety from the use of such equipment. The year saw the review of test details described in the 6 workbooks used by compliance testers for testing of mobile radiographic, mammographic, major radiographic, fluoroscopic, dental and computed tomography equipment. The programme will continue to be reviewed by Council to ensure it remains relevant and up to date with advances in technology.

The Council is supported in its day to day responsibilities by officers of the

34831 Radiological Council - A-R5 517/03/2006 3:38:35 PM


Radiation Health Branch of the Department of Health. These officers are very dedicated and provide both administrative and valued scientific support. From time to time, the loss of key personnel within the Branch to other organisations becomes a cause for concern to the Council since this adds considerable pressure on the remaining officers. The year saw the departure of 3 senior officers holding considerable collective experience in radiation health matters. In addition, the Secretary of the Council who is also the Manager of the Branch commenced extended leave with her responsibilities devolved to other officers. As Chairman, I am continually conscious of the significance of this pressure and encourage the early filling of vacant positions with suitable and well-qualified staff. I maintain close contact with the departmental officers and rely on them to keep abreast with relevant radiation issues and to provide Council and myself with expert advice. I am again pleased to thank them for upholding the high radiation safety standards that we have in this state. Finally, I would like to express my gratitude and appreciation to all the members of Council who have tirelessly given of their expertise during 2005.

Dr P Psaila-Savona CHAIRMAN 16 March 2006


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RADIATION SAFETY ACT 1975 – 2004 STATUTORY RESPONSIBILITIES OF THE COUNCIL The Radiological Council is appointed under section 13 of the Radiation Safety Act to assist the Minister to protect public health and to maintain safe practices in the use of radiation. In its position as an independent regulatory authority, the Council is required to administer the Act and to —

implement the scheme of licensing and registration;

conduct inquiries into alleged contraventions of the Act and, where necessary, to suspend or cancel licences and registrations;

advise the Minister and make recommendations with respect to the

technical aspects of radiation safety requirements, the methods that may be used to prevent or minimise the dangers arising from the use of radioactive substances, irradiating apparatus and electronic products, including the preparation of regulations;

investigate and prosecute offences.

The Council is also required to keep under review manufactured or assembled devices which emit radiation to determine if control of these devices is necessary under the Act. Section 10 requires the Minister at all times to have regard to the expressed views of the Council. MEMBERSHIP OF THE COUNCIL The Council comprises —

a medical practitioner appointed by the Governor on the recommendation of the Executive Director Public Health;

a medical practitioner who is a specialist in radiology or radiotherapy;

a physician specialising in nuclear medicine;

a person who possesses relevant qualifications or experience as a

physicist;


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a person who possesses relevant qualifications or experience as a

radiation engineer or electronic engineer;

a representative of the interests of tertiary educational institutions. Two other persons with special expertise in radiation protection may be nominated by the Minister on the advice of the other members of the Council. The present members, approved by the Governor, are listed in attachment 1. The Council met six times in 2005. ADVISORY COMMITTEES The Council may appoint committees under section 19 of the Act to investigate and advise on any aspect of its functions, or to carry out any function other than those relating to licences and registrations. The present policy is to create, when necessary, short-term working parties which address a specific issue and report back to the Council. The only exception is Council’s Chiropractic Advisory Committee which is appointed to supervise the radiation safety examination for chiropractors who wish to apply for licences to operate diagnostic x-ray equipment. The committee, which also advises Council on other chiropractic matters, met once in 2005 for the annual examination. ADMINISTRATIVE SUPPORT Section 10(4) of the Act provides for the administration of the Act to be paid out of moneys appropriated by Parliament for the purpose. However, the Council is not funded directly and relies on the Department of Health’s Radiation Health Branch for administrative and scientific support. While the greater part of the Branch’s duties are directly concerned with supporting the Council’s needs, and many of the staff are appointed authorised officers under section 4(1) of the Act for this purpose, the Branch also provides separate advice to the Department on a range of radiation issues.


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The Radiation Health Branch also provides the Secretary of the Council. The position has been held by Ms H Upton (Managing Health Physicist) since February 2002, with Mr L Dahlskog (Senior Health Physicist) and Mrs M Aerts (Health Physicist) performing these duties in Ms Upton’s absence. STATE ELECTORAL ACT For the purposes of section 175ZE of the State Electoral Act, the Radiological Council has no expenditure to report. Council’s functions are supported from within the budget assigned by the Department of Health to the Radiation Health Branch. The Council does not have a budget in its own right. STATE RECORDS ACT The Radiological Council’s record keeping systems are managed by the Radiation Health Branch of the Department of Health, and thus the Council’s compliance with the State Records Commission Standard 2, Principle 6 is linked to compliance by the Department of Health. THE RADIOLOGICAL COUNCIL WEBSITE During 2004 the first version of the Radiological Council Website was finalised and was made available for access by the public at the address www.radiologicalcouncil.wa.gov.au. The Website was updated during 2005 to satisfy the greater depth of information being sought by the public concerning the requirements of the Act. The website will continue to be updated to ensure its continued relevance and usefulness. REGISTRATIONS, LICENCES AND TEMPORARY PERMITS Registration and licensing are the principal means by which the use of radiation is regulated. A summary of the legislative system for registration and licensing in Western Australia is included in appendix 1. QUALIFICATIONS AND TRAINING OF RADIATION USERS A summary of the legislative scheme for ensuring the appropriate qualifications and competence of persons applying for licences is included


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in appendix 2. CHANGES TO LEGISLATION There were no amendments made to the Act or its regulations in 2005. RADIATION INCIDENTS Reported incidents involving radiation rarely pose a major health risk to the individuals exposed. Regulation 19A of the Radiation Safety (General) Regulations requires registrants to notify the Council in writing and as soon as practicable should any of the abnormal or unplanned radiation exposures specified in that regulation occur. Although there is no certainty that all incidents are reported, Council encourages reporting and rigorous investigation of the cause as this provides a forum for improving work practices and minimising the recurrence of such incidents The Council was notified of the following 12 incidents during 2005: Medical

Misadministrations

A nuclear medicine practice advised in March 2005 of a misadministration of a diagnostic nuclear medicine radiopharmaceutical to the wrong patient due to confusion over two patients with the same surname. The Radiation Safety Officer (RSO) estimated that one patient received an unnecessary effective dose of about 4 mSv from an unintended administration of 740 MBq 99mTc-HDP bone radiopharmaceutical. The patient was counselled by a medical specialist and a full report from the RSO, including the procedures to reduce likelihood of a recurrence, was provided and considered by Council. Council noted that the follow up action to the incident had been managed well and agreed that no further action was required.

Other Medical Incidents

Council investigated a radiation dose of 19.21 mSv recorded on a personal radiation monitor assigned for a 3 month period to a radiation worker at a hospital.


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The personal radiation monitoring service provider indicated that the badge was stationary with respect to the radiation source at the time of exposure. Neither the radiation worker nor the RSO could offer any plausible explanation for the high dose.

The RSO’s investigation of the incident indicated that it was unlikely that the dose had actually been received by the worker. However, Council agreed that the dose should remain on the worker’s personal dose record.

A hospital reported a release of 8.6 GBq 131I to the sewer. The

incident was caused by a valve blockage in one of the radioactive waste storage tanks and the need to empty the tank to allow plumbers to access the blockage.

Council noted that although the release appeared to exceed the limits specified by Regulation 31(4), taking the daily effluent volume from the hospital into account, the activity concentration averaged over a month did not significantly exceed the regulated limit for that period. The Hospital’s report indicated that measures had been taken to reduce the likelihood of a recurrence of this type of incident. Council acknowledged that with the after-treatment and dilution at the water treatment plant it was unlikely the levels of 131I would have been of concern. No further action was taken.

A radiation dose of 4.45 mSv was recorded on the personal

monitoring badge worn by a worker in the nuclear medicine department of a hospital.

The Radiation Safety Officer (RSO) of the hospital investigated the matter and provided a report which indicated that the high reading was due to contamination of the badge following an incident involving the leakage of 3.46 GBq 131I during labelling preparation of a patient therapy dose. The reading therefore was unlikely to represent a whole body dose to the worker. The RSO reviewed the procedures for dealing with contamination incidents and the nuclear medicine department took delivery of three electronic pocket dosimeters which staff would use during certain laboratory procedures, in addition to their other radiation badges.


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Council considered the report and agreed that the incident should have been detected earlier through routine contamination monitoring and agreed that the incident suggested poor work practices. Council’s investigation of the incident has not been finalised.

A Radiation Safety Officer of a hospital reported in October 2005 of a

dose of 5.55 mSv received on the personal monitoring dosimeter worn by a Nuclear Medicine Technologist previously employed in the Nuclear Medicine Department of the hospital. The dosimeter was worn by the technologist for a 17 day period.

The report stated that staff had been issued with secondary dosimeters for that period as part of the follow-up of previous unusual high doses and that the secondary badge for the technologist recorded a reading of 0.21 mSv for the same period. The RSO investigated the matter and advised that the high reading was likely to have been caused by inadvertent exposure of the dosimeter to prepared radiopharmaceuticals and imaging isotopes when it was left in the radiopharmaceutical laboratory at the end of the technologist’s employment and that the technologist did not herself receive the dose. A further report was submitted by the RSO in November 2005 of two more high doses received on the personal monitoring dosimeters worn by a nurse and a receptionist. During a 25 day period, the nurse’s and receptionist’s dosimeters had recorded a dose of 2.66 mSv and 1.94 mSv respectively. The RSO’s report offered possible explanations for the high doses received on the dosimeters and detailed actions taken to prevent further occurrences. Council was concerned that the doses may indicate a systematic problem evident from the multiple high doses occurring across more than one monitoring period and requested its officers to perform a detailed inspection at the hospital’s radioisotope areas. The inspection had not been finalised in 2005.

Education

A teaching institution advised that following a comprehensive check

of the asset lists for three of its campuses, they were unable to account for 10 demonstration radioactive sources. The Radiation Safety Officer was asked to conduct an extensive search of all campuses to try and locate these missing sources.


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Council discussed the issue and noted that a significant period of time had passed since the incident and that all but three of the sources were exempt under the Radiation Safety Act.

A letter was written to the institution regarding the poor management of the sources requesting to remind all staff of the missing sources and required actions if they should find them. The institution was also asked to review and amend their procedures to include a three monthly audit of all sources. Council accepted the institution’s actions in relation to the matter.

Industrial

A logging company advised Council in May 2005 that two logging

sources (a 74 GBq 137Cs source and a 185 GBq 241Am-Be source) became jammed in a borehole and had to be abandoned offshore in the North West of Western Australia.

The conditions of registration require that where a source is irretrievably lost in a bore hole, written notification is given to the owner and/or operator of the bore hole that the source is to be cemented in situ; the location of the source is to be documented for the owner’s records; and that no further drilling in the immediate vicinity of the source that risks intersecting with the source is permitted. In compliance with the conditions of registration, the registrant took the specified actions to cement the source in place.

An industrial radiography company advised of an incident involving

one of their industrial radiographers and his assistant where an 192Ir source detached from its wind-out cable during routine radiography. The company’s Radiation Safety Officer (RSO) and the radiographer recovered the source. Although the company’s report indicated that neither worker received a significant dose during the recovery operations, the dose report from the personal radiation monitoring service provider indicated that the licensee received a dose of 28.33 mSv, and the RSO a dose of 1.52 mSv.

Interviews of the RSO, radiographer and assistant did not reveal any reason for the high dose, and did not appear to show any breach of the Act. The licensee assumed that the dose was received while climbing out of the boiler in which the radiography was taking place, and during the source recovery.


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The matter is still under investigation.

The Radiation Safety Officer for a mining company advised of an incident that had occurred in July 2005 involving a fixed radiation gauge containing 64 GBq 137Cs which had malfunctioned during isolation, resulting in estimated radiation doses to three workers of 150 µSv, 10 µSv and 10 µSv.

Upon investigation, it appeared that the gauge had been modified from the manufacturer’s original design. Council officers are investigating the incident further, and are seeking further information on the likely cause of the malfunction from the company that had been contracted to repair the gauge.

Council was advised that a company was in possession of an unregistered CO2 level detection device containing a radioactive substance. The company’s registration had expired in June 2003. Council records indicated that no sources had been registered since 5 September 2000.

Council officers visited the company and found that they were in possession of a 3.65 MBq 60Co source. The company had been informed incorrectly by the NSW supplier of the device that the radioactive substance was exempt. The company subsequently applied for registration renewal and licence. Council agreed to restrict the registration to storage only and to decline the application for a licence based on the apparent breach of the Radiation Safety Act. The matter was also referred to the State Solicitor’s Office for advice on prosecution.

Non-Ionising Radiation

Council officers had been contacted by the Western Australian Police

regarding an incident where a green laser was directed into the cockpit of the Police helicopter. The laser was seized by the Police and found to be a 30mW class 3B (labelled as Class IIIb) laser pointer.

Council officers interviewed the individual responsible for the incident who admitted to possession and operation of the laser without a licence or registration. The matter was referred to the State Solicitor’s Office (SSO) for advice on prosecution. Although there was


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sufficient evidence for a prima facie case for a prosecution under section 25 of the Act, the SSO raised the question whether the public interest would be served by prosecution and suggested a suitably worded warning letter demanding a written apology from him to the Police officers involved.

Council noted the SSO’s advice and also discussed the possibility of “copy cat” incidents if prosecution commenced and resulted in sufficient publicity. Accepting the advice of the SSO, Council agreed not to proceed with prosecution.

Other

In 2003, it was alleged by a family member of a former employee at

an institution that the employee’s death from cancer had been due to radiation exposure from a sealed radioactive source. The source was registered under Section 28 of the Radiation Safety Act. The family member alleged that the institution had not ensured that appropriate radiation safety measures were in place.

A subsequent investigation performed by the institution and a review of its report by Council officers had indicated that the maximum credible radiation dose to anyone as a result of exposure to the source would have been extremely low. However, due to the serious nature of the allegations, Council requested its officers to independently review the history of the whereabouts and handling of the source. An extensive review, with oversight by a Council member, was conducted in 2004 including interviews of many current and former employees of the institution. A Report was tabled at Council’s meeting in December 2004 and a copy subsequently provided to the institution concerned. The report concluded that no evidence or information was obtained during the enquiry to demonstrate that there were any breaches of the Act, of the Regulations or any of the conditions, restrictions or limitations imposed on the institution’s Registration in relation to the source. There was also no evidence obtained that any person received a radiation dose from the source which exceeded the limits prescribed in Schedule I of the Radiation Safety (General) Regulations.

The family member of the deceased employee was given a copy of Council’s report by the institution and in early 2005 forwarded a number of further objections to the Council. In April 2005 the


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Council confirmed its previous findings and agreed that it had no further role in any dispute between the family member and the institution.


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PROSECUTIONS In the 2004 report, Council advised that one incident had been referred to the State Solicitor’s Office for advice on prosecution. The following matters were dealt with in 2005.

In 2004, a mining company reported to the Council that an employee might have been exposed to radiation from a fixed radiation level gauge. The employee had performed routine maintenance on a vessel on which the level gauge was installed and on completion of this work noticed that the gauge shutter indicator was half way between ON and OFF. The employee pointed this out to the shift supervisor who isolated the gauge. Calculations performed on a worst case scenario suggested that if exposed to the useful radiation beam, the employee could have received a radiation dose of approximately 1 mSv. However, further investigations by Council’s officers also found that the company did not have either a Radiation Safety Officer (RSO) or a responsible licensee and allegedly was in breach of the Act and regulations. The matter was scheduled for mention before the Perth Magistrate’s Court in February 2006.

A written complaint was received concerning the diagnostic value of

radiographs taken by a chiropractor. Related matters included an apparent failure by the chiropractor to use ‘inverted T collimation’ for AP full spine radiography, a radiation safety technique required under his licence conditions and by Schedule IX of the Regulations. Labelling of the radiographs also did not comply with the conditions of the registration held by the chiropractor.

An inspection of the premises in June 2005 also showed that the x-ray register did not contain all of the information required under the registration conditions. The chiropractor was interviewed concerning the alleged breaches and the matter referred by Council to the State Solicitor’s Office. The chiropractor was prosecuted in December 2005 and pleaded guilty to a number of charges. He was fined $600 and $200 respectively and ordered to pay $360.70 costs.


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MEDICAL AND RELATED RADIATION MATTERS Compliance Testing The Council’s compliance testing program applies to all diagnostic x-ray equipment used on humans and commenced in 1997. No x-ray equipment may be used for human diagnostic purposes unless it has a current certificate of compliance, a certificate of conditional compliance, or an exemption from compliance. The number of compliance tests of diagnostic x-ray equipment assessed by Council in 2005 was 785. A summary of the statistics for the compliance program per type of diagnostic medical imaging equipment is included in attachment 3. Compliance Testing Working Group The 1996 version of compliance testing workbooks currently forms the basis of the Council’s Diagnostic Medical Compliance Testing program. The workbooks and program requirements were extensively reviewed during 2005 by a working group of the Council. New editions are expected to be approved and issued in 2006. Regulation of Medical Radiation Technologists

During 2005 Council continued to liaise with the Legal and Legislation Branch of the Department of Health during development of the Bill for the regulation of medical radiation technologists (MRTs) which had been initiated in 2004.

Registration of MRTs under a separate registration Act with a general exemption from licensing under the Radiation Safety Act was Council’s preferred option, subject to continuing the existing requirement for general direction and supervision by a licensee.

However, following further discussion with the Legal and Legislation Branch, Council agreed that a satisfactory alternative would be to individually license medical imaging technologists who had been registered in keeping with the provisions in the Bill. This compromise appears to satisfy both Council’s concerns as well as those of MRTs. The Medical Radiation Technologists Bill 2005 was introduced to Parliament during the Parliamentary session beginning 18 October 2005.


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Nurse Practitioners The Nurses Amendment Act 2003 amended a range of legislation but its impact on the Radiation Safety Act, contrary to objections raised by the Council, was to give authority to Nurse Practitioners to request a licensee to undertake any diagnosis or therapy using radiation sources prescribed under the Act. A range of medical and other practitioners are presently exempt from licensing under the Act for the purpose of requesting diagnosis or therapy but it is implicit that those practitioners refer patients for procedures that are within their professional competence and that they have both the knowledge and experience to respond appropriately to the outcomes of the diagnostic or therapeutic procedures. The Council has ongoing concerns that patients might be referred for procedures without appropriate consideration of risk versus benefit and has strongly advised against referrals of patients by Nurse Practitioners for procedures other than basic, plain radiography and believes that all radiographic examinations must be interpreted by a Radiologist. Plain radiography excludes examinations by computed tomography (CT), fluoroscopy and all nuclear medicine procedures where the radiation dose received by patients can be significant. However, where a Nurse Practitioner believes that one of these more involved procedures is necessary, the Council is firmly of the opinion that prior consultation with a medical practitioner is essential. The Council also cannot envisage any situation where Nurse Practitioners should refer patients for therapeutic procedures as the radiation doses involved carry risks of acute radiation injury to patients. Referrals of therapeutic procedures should remain solely the province of specialist medical practitioners. The Council raised its concerns over the competency of Nurse Practitioners to refer patients for the range of radiological procedures implied by the 2003 amendment to the Radiation Safety Act with the Department of Health in 2004. The Council was assured that the scope of practice of Nurse Practitioners would be outlined in clinical protocols to be given legal standing via the Nurses Rules and that the Council would be consulted in the preparation of these clinical protocols in 2005. To date, Council has not been invited to participate in the development of the approval process and remains concerned at the potential health risk to patients from inappropriately trained nurse practioners issuing referrals for diagnosis or therapy using radiation.


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The Council is following the matter up with the Director General of the Department of Health. Approvals for Exposure to Radiation for Human Subjects in Medical Research In keeping with the NHMRC Code for the Administration of Ionizing Radiation to Human Subjects in Medical Research (1984), the Council assesses research projects which involve exposing humans to ionising radiation without proven benefits to the irradiated subjects and where the dose to any individual adult subject exceeds 5 mSv in any year. Council assessed and approved the following seven research applications in 2005.

Research Project Title Institution

Positron Emission Tomography and Beta Probe in the Staging of Ductal Carcinoma In Situ of the Breast

Royal Perth Hospital

Inflammation and Vascular Function in Acute Stroke and TIA: Treatment with Atorvastatin and Irbesartan

Royal Perth Hospital

18F-fluorothymidine Positron Emission Tomography in the Detection and Imaging of Suspected or Proven Pancreatic Cancer

Sir Charles Gairdner Hospital

Pilot Study of Preoperative TAC in conjunction with the development of a standard protocol for the management of locally advanced breast cancer – companion study involving MRI and FDG-PET


A Phase III multicentre study of intratumoural/interstitial therapy with TransMIDTM compared to best standard of care in patients with progressive and/or recurrent, non-resectable glioblastoma multiforme


Positron Emission Tomography in Potential Nodal Prostatic Metastases



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Fluorocholine positron emission tomography in previously uncharacterised tumours



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INDUSTRIAL, ENVIRONMENTAL and MINING RADIATION Industrial Compliance Testing The Council’s compliance testing program for fixed radiation gauges commenced in 1999. The program requires that gauges are not used unless they have a current certificate of compliance. The number of compliance tests received by the Council in 2005 was 417. A summary of compliance tests assessed in 2005 is included in attachment 3. Standards for Council Examinations Council had previously agreed that improved control over industrial radiation safety examination standards was necessary and had decided that while course providers may continue to invigilate examinations, all industrial papers would be returned to Council’s officers for marking. The program commenced during the last quarter of 2002. In 2005, Council officers marked 287 examination papers from external course providers. The number of exams marked in each industrial category is listed in attachment 4. MISCELLANEOUS National Directory for Radiation Protection At the Australian Health Ministers’ Conference (AHMC) held in June 2004, the Ministers endorsed the adoption of the National Directory for Radiation Protection, Edition 1, as the Framework for National Uniformity in Radiation Protection. The Ministers also agreed that the first edition of the Directory would not be applied to the mining and mineral processing industries until further work regarding exemption criteria has been undertaken. In 2005, Council set up a working group to review the Radiation Safety Act and Regulations to ensure consistency with Edition 1 of the National Directory. It is anticipated that the working group would be reporting to the Council in 2006. Personal Radiation Monitoring Services Council currently recognises five organisations for the provision of a personal radiation monitoring service in accordance with the Regulations:


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• ARPANSA (Australian Radiation Protection and Nuclear Safety Agency),

the Commonwealth Government’s radiation safety agency in Victoria • New Zealand National Radiation Laboratory, the New Zealand national

radiation safety organisation (Australian agent: Australia Radiation Services, Pty., Ltd., Victoria)

• Australia Radiation Services Pty Ltd, a company based in Victoria • Landauer Inc., a US based company

(Australian agent: Radiation-Wise, Perth, Western Australia) • Global Dosimetry Solutions, a company based in USA. Recognition of Global Dosimetry Solutions was granted by Council following consideration of their quality assurance procedures and advice that the company’s overseas accreditation was accepted by the National Association of Testing Authorities.


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Appendix 1: Registration and Licensing Registrations Section 28 of the Act requires prescribed radioactive substances, x-ray equipment and electronic products, together with the associated premises, to be registered. Registrants may include individuals, companies, organisations or institutions. All x-ray equipment is prescribed while prescribed electronic products include lasers, transilluminators and microwave ovens. Radioactive substances that exceed the exempt quantities prescribed in the regulations are subject to registration. A small number of devices containing radioactive substances in excess of the exempt limits, but which pose a minimal hazard to users, have been exempted by regulation from control under the Act. The numbers of devices and sealed radiation sources registered as at December 31 2005 are included in attachment 5. Licences Section 25 of the Act requires persons who manufacture, store, transport, sell, possess, install, service, maintain, repair, use, operate or otherwise deal with prescribed radioactive substances, x-ray equipment or electronic products to be licensed or, where permitted, work under the direction and supervision of a licensee. Section 29 of the Act also creates an offence for a person to sell any prescribed substances or devices unless they require the purchaser to produce evidence that they hold a relevant licence or are otherwise exempted by the Act or regulations. Sales also must be notified in writing to the Council, without delay, identifying the purchaser and the particulars of the relevant licence or exemption. Exemptions from Licence A licence is not required where a general exemption is provided by the regulations or where a person has been granted an individual exemption from licence. Although exempt from licensing, the regulations nevertheless specify the minimum qualifications or training required for these radiation workers.


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Temporary Permits The shortest period for which a licence or registration can be granted is 12 months. However, for shorter periods an application may be made for a Temporary Permit. Permits cannot exceed a duration of 3 months. Three Temporary Permits were current as at 31 December 2005. Conditions, Restrictions and Limitations A range of performance and safety requirements for radioactive substances, x-ray equipment and the prescribed electronic products are specified in the regulations. However, additional safety measures may be applied by the Council under section 36 of the Act through conditions, restrictions and limitations applied to registrations, licences, temporary permits and exemptions. Failure to comply with a condition is an offence. Attachment 6 shows the types and numbers of licences and registrations (or individual exemptions) granted or renewed in 2005. Commonwealth Government Agencies and Contractors The Radiation Safety Act does not apply to Commonwealth agencies or to their employees (or contractors) who might use radiation in Western Australia. Those agencies are regulated by the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) under the Commonwealth Government’s Australian Radiation Protection and Nuclear Safety Act 1999.


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Appendix 2: Licence Prerequisites Before a licence may be granted, the Council has an obligation to ensure that an applicant has appropriate qualifications, competence and experience (section 33). Protocols have been developed which prescribe the prerequisite qualifications and experience necessary for a wide range of radiation uses. Some qualifications are recognised by the Council because an appropriate degree of radiation safety training is inherent in gaining those qualifications. However, other applicants may be required to attend a recognised radiation safety course and pass an examination. The Council has authority to impose examinations under the Radiation Safety (Qualifications) Regulations. Persons who are not required to hold a licence themselves but who must work under the direction and supervision of a licensee may also be required to hold certain qualifications or to have undergone additional radiation safety training. These requirements may be imposed by regulation or through conditions, restrictions and limitations imposed under section 36. The registrant for the premises where the individual works is primarily responsible for ensuring compliance with these criteria. Courses in various aspects of radiation safety are offered by both the government and private sectors, for example:

X-ray Operator Compliance Testing of Diagnostic X-ray Equipment Fluoroscopy – Medical Industrial Radiography Fixed Radioactive Gauges Portable Radioactive Gauges Well (Borehole) Logging Transport of Radioactive Substances Lasers – Medical and Industrial Unsealed Radioisotope Handling


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Attachment 1: Radiological Council MEMBERS OF THE 10TH RADIOLOGICAL COUNCIL

Members Qualification or Designation Deputy

Appointment under sections 13(2)(a) and 13(3) of the Act

Dr P Psaila-Savona (Chairman)

Medical Practitioner Dr G Groom

Appointment under sections 13(2)(b), 15(1) and 17 (1) of the Act

Dr S Song Radiologist Dr A Kumar

Dr G Groom Nuclear Medicine Physician Dr M McCarthy

Dr R Fox Physicist Dr R Price

Mr J Hunter Electronic Engineer

Mr N Tsurikov Expert in Mining Radiation Hazards

Mr N Hicks Radiographer

Dr N Costa Co-opted member

Mr B Cobb Co-opted member

2005 MEETING ATTENDANCE

10 Feb 14 Apr 9 Jun 11 Aug 20 Oct 8 Dec

Dr P Psaila-Savona D

Dr N Costa A A A A A

Dr R Fox

Dr G Groom

Mr N Hicks A

Mr J Hunter

Dr S Song

Mr B Cobb

Mr N Tsurikov

attended A apology D deputy


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Attachment 2: Legislation Amendments RADIATION SAFETY ACT None RADIATION SAFETY (GENERAL) REGULATIONS None RADIATION SAFETY (TRANSPORT OF RADIOACTIVE SUBSTANCES) REGULATIONS None RADIATION SAFETY (QUALIFICATIONS) AMENDMENT REGULATIONS None


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Attachment 3: Compliance Testing Medical

A Compliant B Conditionally compliant C Non-compliant1

Category A B C Total CT 35 - 1 36 Dental – intraoral 344 1 25 370 Dental – panoramic and/or cephalometric 46 - 7 53 Fluoroscopic – fixed 10 - 19 29 Fluoroscopic – fixed C or U arm 13 - 6 19 Fluoroscopic – mobile 44 - 17 61 Mammography 41 - 9 50 Radiographic – fixed 54 1 43 98 Radiographic – mobile 62 - 7 69

Total 649 2 134 785

Industrial – Fixed Gauges

A Compliant B Non-compliant2

Category A B Total Density 341 16 357 In-stream analysis 10 4 14 Level 104 8 112 Thickness 2 - 2

Total 457 28 485

1 Equipment deemed to be non-compliant may continue to be used for a further three months while the problem is being addressed provided that the reason for non-compliance does not significantly increase the radiation dose to the patient. A re-test is then required. Of the 154 re-tests conducted during 2005, 98% resulted in the equipment being granted either a compliance or conditional compliance certificate. 2 Equipment that has been assessed as non-compliant cannot be used until it has been re-tested and issued with a certificate of compliance.


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Attachment 4: Industrial Radiation Safety Examinations Current at 31 December 2005

Category 2005 2004 2003 Borehole Logging 28 45 18 Fixed Gauges 57 105 39 Industrial Radiography 26 22 41 Industrial Radiography (Advanced) 0 2 1 Industrial Radiography (Assistant) 64 33 82 Portable Gauges 61 45 34 Portable Gauges (WA Requirements) 0 9 2 Transport 13 16 9 Service – Cabinet X-ray 2 1 1 Service – Linear Accelerators (Industrial) 0 1 0 Service – X-ray Analysis 0 3 0 X-ray Analysis – Use 9 8 16 X-ray Analysis – Use and Restricted Service 27 42 16

Total 287 332 259


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Attachment 5: Equipment and Sealed Solid Sources Registered Current at 31 December 2005

A Irradiating apparatus and electronic products B Radioactive substances (sealed sources only)

Category A B Bone densitometry 33 - Cabinet x-ray equipment 86 - Calibration 2 286 CT 111 - CT/SPECT 4 - Dental – intraoral 1699 - Dental – panoramic and/or cephalometric 216 - Education and research 16 865 Fluoroscopic – fixed3 139 - Fluoroscopic – mobile 103 - Gauge – density/level 7 1642 Gauge – in stream analysis - 110 Gauges – logging 6 133 Gauge – neutron moisture/density portable - 237 Gauge – other - 33 Irradiator - 4 Isotope Production 1 - Laser – entertainment 14 - Laser – industrial 43 - Laser – medical 141 - Laser – other medical 103 - Laser – research 73 - Linear accelerator 8 - Mammography 95 - Non-destructive testing 52 55 Non-destructive testing – crawler control - 2 Portable mineral analyser - 25 Radiographic – fixed 397 - Radiographic – mobile 469 - Sealed Sources – other - 62 Simulator 2 - Special purpose x-ray 52 -

3 Includes equipment used in DSA/Cardiac Cath Lab


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Category A B Static detection/measurement - 3 Static elimination - 4 Storage - 221 Superficial radiotherapy 5 - Test source 5 - Therapy 1 37 Therapy – HDR brachytherapy - 2 Transilluminator 89 - X-ray analysis 149 -

Total 4121 3721


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Attachment 6: Licences and Registrations Current at 31 December 2005 Including individual exemptions granted under section 6 of the Act.

X-ray

and/or Electronic Products

Radioactive Substances TOTAL

2005 2004 2005 2004 2005 2004

Licences 2118 1993 1151 1087 3269 3080

Registrations 1301 1264 314 313 1615 1577

TOTAL 3419 3257 1465 1400 4884 4657

Change from 2004 5.0% 4.6% 4.9%


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Attachment 6 (cont) Purposes for Licences and Exemptions from Licence Note: A single licence may be granted for one or more purposes.

A Granted or renewed in 2005 B Total current

A B Purpose 1 3 Bone Densitometry 0 3 Bone Densitometry (Exemption)

23 43 Cabinet X-ray Equipment 2 4 Cobalt Teletherapy Maintenance

18 44 Compliance Testing - Diagnostic X-ray Equipment 31 88 Compliance Testing - Radioactive Gauges 1 3 Cyclotron Operation 2 6 Cyclotron Servicing 0 3 Education (Apparatus)

19 48 Education (Substances) 44 128 Fluoroscopy - Medical 91 181 Fluoroscopy - Medical (Exemption) 2 2 Fluoroscopy - Medical (Non-Specialist Exemption) 0 2 Fluoroscopy - Research 1 3 Fluoroscopy - Veterinary 1 2 Gamma Irradiator - Use

88 215 Gauges - Industrial 3 14 Gauges - Industrial (Installation) 0 0 Gauges - Level (CO2)

44 150 Gauges - Logging 126 291 Gauges - Moisture and/or Density (Portable)

2 7 Gauges - Other (Apparatus) 15 23 Gauges - Other (Substances) 0 3 Installation of X-ray Equipment 2 4 Installation of X-ray Equipment - Dental

12 16 Lasers - Acupuncture 2 7 Lasers - Chiropractic

12 34 Lasers - Dental 2 10 Lasers - Educational 4 10 Lasers - Entertainment

17 41 Lasers - Industrial 77 194 Lasers - Medical 32 61 Lasers - Physiotherapy


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A B Purpose 11 32 Lasers - Research 15 31 Lasers - Service 0 3 Lasers - Veterinary 0 1 Manufacture of Lasers and Laser Products 1 5 Manufacture of X-ray Equipment 1 1 Medical Physics

69 162 Medical Radiology 0 2 Non-Medical Irradiation 6 24 Nuclear Medicine - Diagnostic 6 23 Nuclear Medicine - Therapeutic 2 2 Nuclear Medicine - Veterinary 5 14 Pathology Tests 6 26 Portable Mineral Analysers 5 8 Portable Mineral Analysers (X-ray) 3 7 Possession of X-ray Equipment – Diagnostic Medical 1 1 Quality Assurance Procedures 5 11 Radioactive Ores - Mining and/or Processing 0 5 Radioactive Substances - Calibration Sources 0 2 Radioactive Substances - Medical

10 44 Radioactive Substances - Sale 5 15 Radioactive Substances - Service of Devices 0 1 Radioactive Substances - Tracer Studies 7 17 Radioactive Substances - Tracer Studies (Industry) 1 1 Radiography - Chiropractic (Exemption)

10 42 Radiography - Chiropractic (Extended) 33 90 Radiography - Chiropractic (Restricted) 84 209 Radiography - Industrial (Gamma) 84 210 Radiography - Industrial (X-ray) 1 3 Radiography - Medical (Direction and Supervision)

226 526 Radiography - Veterinary 1 2 Radiology - Veterinary 2 15 Radiopharmaceutical Manufacture and Dispensing 4 15 Radiotherapy - Medical (Apparatus)

10 25 Radiotherapy - Medical (Substances) 3 11 Radiotherapy - Medical Superficial 1 4 Radiotherapy - Veterinary 9 21 Research

30 94 Research - Unsealed Radioactive Substances 3 5 Research - X-ray

11 18 Sale of Electronic Products 19 44 Sale of X-ray Equipment


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A B Purpose 5 16 Service of X-ray Equipment - Analytical 5 10 Service of X-ray Equipment - Dental

25 53 Service of X-ray Equipment - Diagnostic 7 25 Service of X-ray Equipment - Diagnostic (Extended) 1 2 Service of X-ray Equipment - High Energy

Therapeutic 3 8 Service of X-ray Equipment - Industrial NDT 0 2 Service of X-ray Equipment - Intraoral 4 15 Service of X-ray Equipment - Linear Accelerators 6 13 Service of X-ray Equipment - Other 4 9 Special Purpose Enclosed X-ray Equipment 0 1 Static Detection 1 1 Static Electricity Measurement 1 1 Static Elimination 1 5 Storage 9 26 Transilluminators

26 63 Transport 1 1 X-ray Analysis 1 2 X-ray Analysis (Research)

19 54 X-ray Analysis - Use 40 101 X-ray Analysis - Use and Service (Restricted)


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ABBREVIATIONS General Terminology

ARPANSA Australian Radiation Protection and Nuclear Safety Agency

CT Computed Tomography CT/SPECT Computed Tomography/Single-Photon Emission

Computed Tomography DSA Digital Subtraction Angiography NHMRC National Health and Medical Research Council PET Positron Emission Tomography

Units of Activity

Bq becquerel (1 disintegration per second) MBq megabecquerel (1,000,000 becquerels) GBq gigabecquerel (1,000,000,000 becquerels)

Units of Effective Dose

Sv sievert

(1 joule per kilogram multiplied by a modifying factor for the type of radiation and the radiological sensitivities of the organs and tissues being irradiated)

mSv millisievert (one thousandth of a sievert)

µSv microsievert (one millionth of a sievert)

radiological council annual report 2005...radiological council 2005 annual report radiation health...

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