Welcome to the IRS Newsletter for December 2009. As the festive period draws ever closer IRS would like to extend our warmest seasons greetings to all of our customers and wish you all the best for 2010.

IRS will be closing at 3pm on Thursday 24th December for Christmas and will reopen on Tuesday 29th. We will then close for new year at 3pm on the 31st December before reopening on the 4th January 2010. During this time emergency calls will be redirected to one of our RPAs.

In the meantime, if you have any comments on our newsletter forward them to admin@irs-limited.com

See you in the New Year,

The IRS Team

Contents

Care Quality Commision

On 1st November 2006 an amendment to the IRMER regulations came in to force.  Whilst there were no fundamental changes to the requirements of the regulations there were some changes to the definitions and enforcing authority.  For example:

Referrer – replace ‘medical practitioner, dental practitioner or other Health Professional’ with ‘Health Care Professional’.

Practitioner - replace ‘medical practitioner, dental practitioner or other Health Professional’ with ‘Health Care Professional’.

The following link should guide you to it. Click Here

The enforcing authority changed from the Department of Health to the Healthcare Commission (HCC). However on 1st April 2009 the enforcing authority for IRMER was transferred to the Care Quality Commission (CQC).

The CQC are now responsible for monitoring and ensuring compliance with IRMER Regulations and they are also the authority to be notified in cases of Exposure Much Greater than Intended (MGTI).  Below is a link to the CQC website where you can obtain information on reporting incidents along with the findings of HCC/CQC reports in to IRMER compliance, information on the CQC inspection programme for the coming year and links to other useful resources.  We hope you find it useful but please do not hesitate to contact IRS if you need any further advice and guidance particularly in respect of reporting incidents.

For more click here

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Exposures Much Greater Than Intended (MGTI)

The Healthcare Commission are the government body responsible for the enforcement of the IR(ME)R 2000 regulations in England.
                                                      
Under regulation 4 (Duties of the employer) article 5,  the following requirements are set out in law

'Where the employer knows or has reason to believe than an incident has or may have occurred in which a person, while undergoing a medical exposure was, otherwise than as a result of a malfunction or defect in equipment, exposed to radiation to an extent much greater than intended, he shall make an immediate preliminary investigation of the incident and unless, that investigation shows beyond a reasonable doubt that no such overexposure has occurred, he shall forthwith notify the appropriate authority and make or arrange for a detailed investigation of the circumstances of the exposure and an assessment of the dose received.'

Firstly you should note that it is the employer's responsibility to determine whether a dose greater than intended may have occurred. Under IR(ME)R you are only concerned with overexposures that have occurred as result of a procedural failures or human error. Where an employer suspects an exposure greater than intended may have occurred as a result of a malfunction or defect in equipment they should refer to the Ionising Radiation Regulations 1999 (IRR 99). Specifically regulation 32 (6) and (7).

Whether the suspected dose greater than intended is due to an equipment malfunction or a procedural failing, the way that the employer must deal with the situation is virtually the same. The following steps are should be carried out by the employer:

1.    Undertake a preliminary investigation to determine whether a dose greater than intended may have occurred.

2.    If the preliminary investigation concludes that a dose greater than intended may have occurred you should supply the details of the incident to the MPE/RPA to assess what the 'intended' dose should have been and what the 'actual' dose received was. The MPE/RPA will then assess whether the dose is reportable or not. The decision to notify the appropriate enforcement authority is based on whether guideline multiplying factors have been exceeded. The multiplying factors that are used are set out in HSE Guidance Note PM 77 'Equipment used in connection with medical exposure' both the 2nd and 3rd editions of this document.

3.    If the dose is reportable you should notify the appropriate agencies immediately:

• Care Quality Commission (Procedural/human error) - please click here
• HSE (equipment malfunction or defect) - the incident should be reported to the local HSE office, the address can be obtained from the local HSE infoline on 0845 345 0055 or from the HSE website at www.hse.gov.uk. A fax would suffice. The notification is made under IRR 99 regulation 32(6) not RIDDOR.

4.    A notifiable or reportable incident will require a detailed investigation to be undertaken, to fulfil the requirements of IR(ME)R reg 4 (5) and IRR 99 Reg 32 (6) and (7). The 4 main objectives of the investigation to be undertaken by the employer are:

• To establish what happened
• To identify the defect or malfunction in the radiation equipment and to establish its causes or as under IR(ME)R to determine the root cause of the incident
• To decide upon and implement remedial action to prevent a recurrence
• To estimate the dose received by all persons involved in the incident.

For further reading I would suggest the relevant CQC web pages from the link above and also that a copy of PM 77 is obtained from HSE.

Duplicate exposures – as opposed to unintended exposures When a patient receives the correct examination but on the wrong side e.g. left leg instead of right leg, however an unintended exposure is when a patient undergoes the wrong examination or the wrong patient receives the correct examination.

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Summary of Legislation

In the UK, The Health and Safety at Work etc Act 1974 [1] sets out legal responsibilities of employers and employees to ensure their own safety and that of others. This Act of Parliament did not originally include protection of ionising radiations and has subsequently been expanded by the addition of supplementary pieces of legislation (known as statutory instruments). Statutory instruments of relevance to protection from ionising radiation include IRR99 and IRMER2000.

IRR99

Ionising Radiation Regulations 1999

IRR99 [2] came into effect on 1st January 2000, superseding the Ionising Radiation Regulations 1985 (IRR85). It was issued to implement Basic Safety Standards Directive 96/29/Euratom [4] in Great Britain, whilst still providing the regulations previously given in IRR85. IRR99 also replaced the Ionisation Radiation (Outside Workers) Regulations 1993.

These regulations and supporting Approved Code of Practice (ACOP) [7] apply principally to the exposure to ionising radiations of staff in whatever ‘industry’ they work, but also includes others who may be exposed by the ‘industry’. This includes exposure to naturally occurring ionising radiation and man-made sources, whether the radiation exposure occurs externally (e.g. X-ray unit) or internally (e.g. inhalation of radioactive substance). In effect, IRR99 apply to three categories of work:

• Practices. This is the most common category and refers primarily to work with artificial sources, including both the operation of equipment that emit ionising radiation, such as X-ray units, and also man-made radioactive substances. The term ‘Practices’ does however also include work with materials containing naturally occurring radionuclides when they are being processed for their ‘radioactive, fissile or fertile properties’. Therefore, all activities in the nuclear fuel cycle are deemed as practices and subject to IRR99;
• Work in radon atmospheres at concentrations above specified action levels e.g. work in mines or workplaces where radon-222 concentration exceeds defined action levels;
• Work with materials containing naturally occurring radionuclides.

There are 41 regulations given in IRR99, which are primarily given as responsibilities for the radiation employer (Regs 5-33). Examples of these responsibilities include: acquiring authorisation to work with X-rays, notifying HSE of work with radiation, providing training to staff, and appointing a radiation protection advisor (RPA) and radiation protection supervisor (RPS) when necessary. The employer also has a duty of minimising doses by: performing risk assessments, designating controlled/supervised areas, dose monitoring of areas/staff, implementing use of dose constraints, providing written procedures e.g. local rules (via RPA), and providing personal protective equipment (PPE) if necessary.

There are also a few duties for the radiation protection supervisor (RPS) e.g. supervise adherence to local rules, however responsibility here rests with the employer. Reg.34 give duties for the employee, e.g. not knowingly expose themselves or others to radiation greater than necessary.

Summary

IRR99 implement safety standards to ensure the exposure of staff to ionising radiation is kept as low as reasonably practicable (ALARP principle) and does not exceed dose limits specified for individuals.   

IRMER or IR(ME)R 2000

Ionising Radiation (Medical Exposure) Regulations 2000

IRMER [3] came into effect on 13th May 2000, superseding Ionising Radiation (Protection of Persons Undergoing Medical Examination or Treatment) Regulations 1988 [5] (POPUMET). IRMER was issued to implement most of the Medical Exposures Directive 97/43/Euratom [6]. The remainder is covered in IRR99, which includes both the use of equipment associated with medical exposures, and doses to voluntary ‘comforters and carers’ of those undergoing medical exposures, although no legal dose limits apply to this group.

There are four distinct roles defined under IRMER:

• The Employer must provide: a framework under which medical exposures may take place (A); recommendations concerning referral criteria for medical exposures, including radiation doses, and shall ensure that these are available to the referrer (B); written procedures for every type of examination (C); QA programmes (D); and Dose Reference Levels (E). The employer must also ensure that all practitioners and operators are trained (check registration documents) (F) and investigate “much greater than intended” medical exposures (G).
• The Referrer e.g. GP, must provide adequate and relevant clinical information to enable the practitioner to justify the exposure.
• The Practitioner e.g. radiologist/radiographer, is entitled in accordance with the employer’s procedures to take responsibility for an individual medical exposure and determine whether there is justification for the medical exposure.
• The Operator is any person who is entitled, in accordance with the employer’s procedures, to carry out practical aspects of medical exposures e.g. radiographer. They are responsible for selecting the equipment and methods to ensure that the dose is kept ALARP.

IRMER states a medical exposure can only be undertaken when there is justification (decided by practitioner). Strictly speaking, the referrer is requesting a clinical opinion from the practitioner rather than an X-ray examination.

Whether there is justification of each individual medical exposure should be based on his/her knowledge of the hazard associated with the exposure and the clinical information supplied by the referrer. The practitioner will decide on the appropriateness of the request, best use of imaging modality available, risk versus benefit and the urgency of exposure e.g. if patient is pregnant delay the procedure until after delivery. In general radiography, the operator can authorise the request if it follows set criteria.

Summary

IR(ME)R applies to protection of those undergoing a medical examination or treatment. These regulations ensure radiation doses to patients are kept ALARP whilst still ensuring satisfactory diagnostic information or therapeutic response (optimisation through the ALARP principle).

[1] Health and Safety at Work etc Act 1974 HMSP 1974 ISBN 0 10 543774
[2] The Ionising Radiations Regulations 1999 SI 1999/3232 Stationary Office 1999 ISBN 0 11 085614 7 (http://www.opsi.gov.uk/si/si1999/19993232.htm)
[3] The Ionising Radiation (Medical Exposure) Regulations 2000, SI 2000/1059 Stationary Office 2000 ISBN 0 11 099131 1
(http://www.opsi.gov.uk/si/si2000/20001059.htm)
[4] ‘Council Directive 96/29 Euratom of 13th May 1996 laying down basic safety standards for the protection of health workers and the general public against the dangers arising from ionising radiation’. Official Journal of the European Communities. 1996 Vol.39 (L159) 1-114
[5] The Ionising Radiation (Protection of Persons Undergoing Medical Examination or Treatment) Regulations 1988 SI 1988/778 HMSO 1988 ISBN 0 11 086778
[6] ‘Council Directive 97/43 Euratom of 30th June 1997 on health protection of individuals against the dangers of ionising radiation in relation to medical exposure.’ Official Journal of the European Communities 1997 Vol.40 (L180)
[7] Work with ionising radiation. Ionising Radiations Regulations 1999. Approved Code of Practice and Guidance. HSE books. ISBN 0 7176 1746 7
[8] http://www.radman.co.uk/GUIDE/IRR99_regulations.asp. Accessed on 22/10/2008.

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Training

Radiation Protection Supervisor Training

A one-day refresher course for current RPSs was held on 23rd November.

Future training events:

IRS are running a one day Safe Use of Medical Lasers Course on the 13th January 2010. Our next 3 day training course for new RPSs will take place from 15 – 17 March 2010.

To view details of any of our courses and register online please visit the courses section of our website which can be found here

Alternately contact the course administrator Tracy Barlow at tracybarlow@irs-limited.com

A one day course to support level A testing in CR/DDR will take place in September/October 2010 (final date to be confirmed early in the new year).

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QC of Image display devices

Image Display Devices – User Resources

We have had an increasing number of enquiries with regards to the specific QA requirements for monitors and display devices.  We would like to refer you to the advice and external references below for further guidance:

1.  IPEM Report 91, Chapter 7 pp49-56 inclusive outline key recommended checks for "primary" monitors (see page 49, attached).  You should consider what falls into this category at the Trust (or off-site as the case may be).  Key tests include general monitor condition, greyscale, distance and angle calibration, and resolution checks.

2. You will also find below:

a) The link for an AAPM recommended test image for 1K monitors.  Similar images may already be available from your PACS or display equipment vendor(s). Click here

b) The link for an AAPM recommended test image for 2K monitors.  Similar images may already be available from your PACS or display equipment vendor(s). Click here

c) An extract from Paul Charnock's MSc to explain the nature of each test and what to look for (as a bare minimum "Level A" type test, taking the IPEM approach - other methodologies are available for which we can provide slides and datasheets.
  
For specific queries, such as suitable meters, software (Viewers/QC programs), we would be happy to liase with you and your suppliers to facilitate testing.  Your feedback is appreciated; please contact IRS if we can be of further assistance admin@irs-limited.com

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Level A Testing in CR/DDR

a. Distortion
The test pattern has a grid in the background.  This should be visually checked for distortion.  As with the AAPM protocol, visual assessment method, there is no actual guidance, other than the viewer should look for major sources of distortion.

b. Luminance Response
It is recommended that each step from 0% to 100% should be distinct from its neighbours.  Luminance measurements can also be taken and graphed.  This graph gives a baseline for future performance.

c. Contrast
The 5% on 0% & 95% on 100% squares should not only be visible, but also have the same level of visibility (see figure 4.7).  It is recommended that the contrast and brightness controls on the display device, along with ambient light conditions be adjusted to give this equal visibility.  Once this has been achieved, any contrast / brightness controls should be disabled.

Figure 4.7: The 5% on 0% and 95% on 100% contrast patches from the SMPTE test image
(The patches have been brightness and contrast adjusted for ease of viewing)

d. Resolution
The pattern contains two sets of resolution bar groups; high contrast and low contrast (See figure 4.8).  The high contrast groups show increasing resolution (line pairs per millimetre) with constant contrast, while the low contrast have constant resolution (line pairs per millimetre) but decreasing contrast.  At least two bar groups should be visible with the naked eye when the image is set to full screen, and all should be visible with the aid of a magnifying glass for both sets.  Luminance can also be measured for each set.  The luminance value for the vertical patterns should be compared with the horizontal patterns.

Figure 4.8: High and low contrast resolution bar groups from the SMPTE test image

e. Luminance Uniformity
The protocol simply states that the resolution patterns should be consistent at all five locations.  This is vague.  There are no limits or standards to compare to, or no further expansion of method. 

f. Veiling Glare
There are a hard white-on-black rectangle and a hard black-on-white rectangle in the image (see figure 4.9).  The edges should appear sharp, with no blurring of edges.

Figure 4.9: The veiling glare patches from the SMPTE test image

Current Recommendations for QA in CR/DDR

Please click here for a presentation on QA in CR/DDR.

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Training Initiatives

QADDS user training days – March & December 2009

IRS invited representatives from local departments to attend an informal training half-day at their Brunswick Business Park office, Liverpool during March and December 2009.  The aim of the sessions was to review and update local QC and patient dose data so that it can be successfully logged and reviewed as is required under IRR 99 and IR(ME)R 2000 legislation.  The sessions were free of charge. 

IRS Trust customers, who are now part of QADDS online instance, brought their own hardcopy or excel-based quality control results in order to engage in an online “refresher”; entering data, checking baselines, and charting the results in the following areas:

Tube Output tests,
Beam Alignment/Light Beam Diaphragm tests
Automatic Exposure Control Tests,
Basic CR and DDR checks.
Fluoroscopic Image Quality

They were able to access their own QADDS entities via the web, just as is possible in the department, with the advantage that in a small group environment, other users and IRS staff were in attendance to clarify results, verify protocols, and set up baselines where these have not yet been established.

A short session on patient dose audit was also given on the day, that allowed staff to chart audit results and examine the mean values for each exam and room, in order that they could establish local diagnostic reference levels (LDRLs) in line with legislation and the best practice defined in nation protocols and IPEM Report 88 “Guidance on the Establishment and Use of Diagnostic Reference Levels for Medical X-Ray Examinations”.

Lunch was provided and there were opportunities to discuss improving QA cycles based on any recent updates to local equipment list and/or RIS supplier.

The days were deemed a great success with staff staying beyond allocated time to discuss issues and procedures.

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Research & Development Publications

In June IRS staff made three presentations at the Third Medical Imagaing Conference in Malmö.

• Mike Moores presented 'A study in Europe of patient dosimetry in diagnostic radiology – protocol development and findings' Click here to view abstract (PDF). Mike also presented 'Web based tools for quality assurance and radiation protection in diagnostic radiology' Click here to view abstract (PDF)
• Jason Fazakerley presented 'Application of Statistica for analysis of large patient dose data sets obtained from
  RIS' Click here to vew abstract (PDF)

In September IRS staff made four presentations at the Medical Physics and Biomedical Engineering World Congress which was held in Munich.

• Mike Moores presented 'Dosimetry and quality control in medical imaging applications' Click here to view (PDF)
• Paul Charnock presented 'Radiology workload analysis: role and relevance in radiation protection in diagnostic radiology' Click here to view (PDF)
• Matt Ward presented 'Experiences of in-field and remote monitoring of diagnostic radiological quality in Ghana using an equipment and patient dosimetry database' Click here to view (PDF)
• Ryan Wilde presented 'Automating patient dose dose and clinical audit using RIS data' Click here to view (PDF)

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International collaboration

International Collaborations and Congratulations to our Ghanaian Friend and Colleague, (Dr) Eric Ofori!

IRS has continued expanding academically and geographically by supervising and providing x-ray test kit and QADDS IT resources to research students from the University of Liverpool, most recently, Ghanaian national Eric Ofori who was awarded a PhD for his thesis work “Development of Quality Standards for Diagnostic Imaging in Ghana”. 

In mid-2008, Matt Ward was fortunate enough to venture out to Ghana, witnessing first-hand the delivery of radiological services, visiting key suppliers, educators and radiation protection regulators, as well as delivering training along with Eric and Dr. Di Scutt from Liverpool Uni (School of Health Sciences).  This consolidated relationships that shall provide further resources in the field of radiological quality assurance in 2010 and beyond.  IRS has customised a QADDS account for Eric and some 10 hospitals in Ghana so that patient exposure factors can be uploaded and viewed via the internet.

More information on this activity can be found in Matt’s international report from RAD December 2008 issue (which can be viewed here), and also the conference proceedings of IFMBE 2009 held in Munich in September 2009.  We wish Eric congratulations and all the best for the future scientific and clinical work he shall undertake in his career.

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Calderdale & Huddersfiled NHS Foundation Trust and Aedas

IRS would like to welcome Calderdale and Huddersfield NHS Foundation Trust and Aedas as two of our latest Radiation Protection customers. We look forward to what will hopefully be a long and succesful working partnership with both of these customers. For more details on either customer check out the following websites.

http://www.cht.nhs.uk/

http://www.aedas.com/

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Mavis Taunton, our financial administrator for the last 9 years, has now retired from IRS and has relocated to London.   Sue Hird has taken over this position, so can you now contact Sue at IRS either by phone 0151 709 6296 or e-mail Suasnhird@irs-limited.com for anything in connection with financial issues or film badge enquiries/additions/deletions.

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Dr Michael Moores - Company Director/RPA/LPA - mikemoores@irs-limited.com

Mr Paul Connolly - Principal Scientific Officer/RPA - paulconnolly@irs-limited.com

Mr David Hughes - Technical Services Manager/RPA/LPA - davidhughes@irs-limited.com

Mrs Elaine Highton - Company Director/Business Manager - elainehighton@irs-limited.com

Ms Sue Hird - Finance Officer/Personnel Dosimetry Administrator - susanhird@irs-limited.com

General enquiries - admin@irs-limited.com

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