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IR(ME)R Compliance for Dental Practices: A Guide for Employers, Referrers, and Operators, Lecture notes of Radiography

Guidance for dental practices on complying with the Ionising Radiation (Medical Exposure) Regulations (IR(ME)R). It covers the roles and responsibilities of duty holders, entitlement, training, justification and authorisation, optimization, research, medico-legal, occupational health surveillance, diagnostic reference levels, clinical evaluation, incidents, clinical audit, quality assurance, protocols, and equipment inventory.

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AnExplanationGuideforDentalPractices
December2011
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Download IR(ME)R Compliance for Dental Practices: A Guide for Employers, Referrers, and Operators and more Lecture notes Radiography in PDF only on Docsity!

Ionising Radiation (Medical Exposure) Regulations 2000,

(as amended)

(IR(ME)R)

An Explanation Guide for Dental Practices

December 2011

CONTENTS PAGE

    1. Introduction
  • 2 Duty Holders and their responsibilities - 2.1 Employer - 2.2 Referrer - 2.3 Practitioner - 2.4 Operator - 2.4.1 Medical Physics Expert - 3.1 General requirements 3 Entitlement - 3.2 Specific requirements for different categories of employment - 3.3 Scope of entitlement - 3.4 Employers Written procedures for entitlement of duty holders
  • 4 Training
  • 5 Justification and Authorisation
  • 6 Optimisation
  • 7 Research
  • 8 Medico‐legal
  • 9 Occupational Health Surveillance
  • 10 Diagnostic Reference Levels
  • 11 Clinical Evaluation
  • 12 Incidents
  • 13 Clinical Audit
  • 14 Quality Assurance
  • 15 Protocols
  • 16 Equipment Inventory
  • 17 IR(ME)R within the existing Radiation Protection File
  • 18 References
    • Appendix 1 – Statements for Radiation Protection File
    • Appendix 2 – Schedule 1 of IR(ME)R
    • Appendix 3 – Example of Guidelines for the authorisation of dental exposures
    • Appendix 4 – Example of Dental Protocols
    • Appendix 5 – Example of Dental Exposure settings
    • Appendix 6 – Example Training Record

It may not be practicable for the employer to personally carry out all the duties required of the employer by IR(ME)R. Whilst the task of carrying out these duties may be delegated to others, the legal responsibility will always remain with the employer. Therefore, any such delegation should be properly documented, along with arrangements by the employer to oversee implementation of these duties by the delegated person.

The duties of the employer are –

a) To ensure that appropriate written procedures are in place (Regulation 4(1)) and are subject to a quality assurance programme for document maintenance (Regulation 4(3)b). These written procedures shall include those defined in Schedule 1 of IR(ME)R, for example, procedures for entitlement of all duty holders, clinical evaluation and audit. A comprehensive list of Schedule 1 procedures may be found in Appendix 2 b) To ensure that the procedures are complied with by entitled practitioners and operators (Regulation 4(1)a) c) To ensure that the training needs of entitled practitioners and operators are met and that there is continuing education for these duty holders (Regulation 4(4)). d) To ensure there is an up to date training record for all entitled practitioners and operators, including where the employer is concurrently the practitioner or operator (Regulation 11(4)) e) To establish recommendations on referral criteria for dental exposures and make these available to all entitled referrers (Regulation 4(3)a). f) To ensure that appropriate written protocols are in place for every type of standard radiological practice and each piece of equipment (Regulation 4(2)). g) To establish diagnostic reference levels (DRLs) for standard radio‐diagnostic examinations and ensure that there is a mechanism for assessment of compliance with these DRLs. If it is known that the DRLs are consistently exceeded, the employer shall set up a review and shall ensure that corrective action is taken (Regulation 4(3)c and (Regulation 4(6)). h) If research is carried out at the practice, to establish ‘dose constraints’ for biomedical and medical research programmes where there is no direct medical benefit to the individual (Regulation 4(3)d). i) To establish a process for the investigation of incidents resulting in exposures much greater than intended and for reporting such incidents to the appropriate authority (Regulation 4(5)). j) To ensure that a medical physics expert is retained and provides advice on matters relating to radiation protection concerning dental exposures (Regulation 9(1)). k) To keep an inventory of equipment and ensure that this equipment is limited to the amount necessary (Regulation 10(1) and Regulation 10(3)).

2.2 Referrer A referrer is defined within IR(ME)R Regulation 2 as a registered healthcare professional who is entitled in accordance with the employer's procedures to refer individuals to a practitioner for dental exposure.

The referrer is responsible for supplying the practitioner with sufficient medical data (such as previous diagnostic information or medical/dental records) relevant to the dental exposure to enable the practitioner to decide on whether there is a sufficient net benefit (Regulation 5(5)). The referrer should take a history and perform a relevant assessment through the charting of the patients dental anatomy prior to requesting the radiograph, and document this information in the patient’s dental record.

The referrer is expected to consider the specific ‘Referral Criteria’ provided by the employer when making a referral. Referral criteria should include the clinical problem or diagnosis, the type of radiograph required, an indication of the radiation dose to the patient, and any additional relevant comments such as the recommended interval between radiographs. The Faculty of General Dental Practitioners “Selection Criteria for Dental Radiography” 8 , British Orthodontic Society’s – Orthodontic Guidelines 9 or other European criteria may be adopted. For cone beam CT (CBCT) referral criteria based on the recommendations of SEDENTEXCT could be utilised 10.

The referrer is usually a dentist, but potentially could also be a GDC dental hygienist or dental therapist 11.

Where it is necessary for a dentist to refer a patient for a medical exposure (such as an OPG or CBCT) that cannot be undertaken within the dental practice itself, and where it is not anticipated that any additional examination of the patient will take place, then the dentist remains as the referrer, and must be so entitled by the employer at the site where the exposure is undertaken (see Section 3).

It is for the employer where the radiograph is taken to ensure that all such ‘external’ referrers are properly entitled.

2.3 Practitioner IR(ME)R Regulation 2 defines a practitioner as ‘a registered healthcare professional who is entitled, in accordance with the employer’s procedures, to take responsibility for an individual dental exposure’. This is a different definition to that of a ‘dental practitioner’ and care should be taken not to confuse the two.

Whilst the main duty of the IR(ME)R practitioner is the justification of individual dental exposures; the practitioner must also: a) Comply with the employer’s procedures (Regulation 5(1)) b) Cooperate with the operator regarding practical aspects, with other specialists and staff involved in a dental exposure, as appropriate (Regulation 5(6)) c) Provide guidelines if they require entitled operators to authorise against them (Regulation 6(5)). See Section 5 d) Ensure, to the extent of their involvement with the exposure, that the dose arising from the exposure is kept as low as reasonably practicable (Regulation 7(1)) e) Only carry out a duty if they are trained to do so (Regulation 11(1))

Normally the role of the practitioner is carried out by a dentist.

2.4 Operator Under IR(ME)R Regulation 2 an operator is ‘any person who is entitled, in accordance with the employer’s procedures, to carry out practical aspects of dental exposures, except where they do so as a trainee under the direct supervision of a person who is adequately trained’.

The operator’s duties are to take responsibility for each and every practical aspect which he/she undertakes. These duties may be carried out by a dentist, other dental professional or any other person involved in the process of taking a radiograph.

Examples of practical aspects might be: o Identification of the patient o Carry out OPG and cephalometric exposures o Carry out intra oral exposures o Carry out Cone Beam CT exposure o Process dental film or CDR plates o Clinical evaluation of dental exposures o Undertake QA of equipment

The range of duties for some operators may be fairly limited e.g. process dental film, but still must be specified. For this, it is recommended that employers establish a list of competences against which each operator may be entitled. (See Dental Employer’s Written Procedure EP1 Appendix 2)

Consideration should be given to the training requirements appropriate to each of the operator’s defined competences. (See Dental Employer’s Written Procedure EP1 Appendix 1)

Whilst the primary role of the operator is to carry out the practical aspects of an exposure, operator must also a) Comply with the employer’s procedures (Regulation 5(1)) b) Cooperate with the practitioner, regarding practical aspects, with other specialists and staff involved in a dental exposure, as appropriate (Regulation 5(6))

For dentists, there are three categories of employment. These are i. Salaried dentists employed by the NHS Health Board ii. Self employed dentists treating NHS patients iii. Independent (private) dentists with no NHS patients

For the first of these categories, the employer is the Chief Executive of the NHS Health Board, and the salaried dentist is subject to all applicable provisions of the NHS Health Board’s Employer’s Written Procedures, including those for entitlement of duty holders. In this case, the ‘entitler’ shall be the Chief Executive of the NHS Health Board, or (normally) the person delegated by the Chief Executive for this function.

For the second of these categories, the employer would normally be the person who is recognised as the practice owner, and that person is responsible for providing the relevant Employer’s Written Procedures, including those for entitlement of duty holders. Any such practice is subject to NHS Health Board practice inspection provisions, and this shall include an overview that the relevant Employer’s Written Procedures and protocols for compliance with IR(ME)R are in place. Neither the practice owner nor any staff operating from within the practice is subject to the NHS Health Board’s Employer’s Written Procedures for any functions undertaken within the practice.

Independent dentists with no NHS patients are not subject to the provisions of the NHS Health Board’s Employer’s Written Procedures. Such practices must define clearly who is the employer (normally the practice owner) for the purposes of IR(ME)R, and this person is responsible for providing the relevant Employer’s Written Procedures and protocols, and for entitlement of all duty holders.

A dentist in any of these categories who refers a patient to an NHS Health Board for a dental exposure (such as an OPG) must be entitled by the NHS Health Board as a ‘referrer’, and shall then be subject to the ‘referral criteria’ issued by the NHS Health Board (in their Employer’s Written Procedures), and any relevant additional provisions for clinical evaluation of the resulting image (see Section 3.3).

Associate dentists must be entitled by the employer for the tasks they undertake within the dental practice and comply with the practice Employer’s Procedures.

3.3 Scope of entitlement Entitlement as a practitioner or operator must be restricted to those functions for which the duty holder is properly trained and experienced. To achieve this, employers should define a set of ‘competences’ which are applicable for the various staff groups (registered dentists, dental nurses etc.), then, for each staff member, assess and assign the appropriate range of duties according to training and competence. The General Dental Council have provided a Scope of Practice for its members which should also be considered 11.

Appropriate assessment of competence might include: For referrers: Competent to refer for all dental exposures within the practice For practitioners: Competent to justify all dental exposures within the practice For operators: i Competent to identify the patient prior to a dental exposure in accordance with Employer’s Written Procedure EP ii Competent to carry out all dental exposures within the practice iii Competent for clinical evaluation of all dental exposures carried out within the practice iv Competent for clinical evaluation of all dental exposures carried out by the NHS Health Board for patients referred by the practice v Competent to process films vi Competent to change chemicals in a dental processor vii Competent to carry out quality assurance on equipment

The employer may nominate specific individuals as competence assessors where it is impractical for them to personally assess all duty holders. A competence assessor must be entitled and experienced in the duties they are assessing.

For staff members that have been working within a practice for some time and are known by the competence assessor to be competent to undertake certain duties, it is not expected that they be reassessed and asked to demonstrate competence. They may be deemed competent by their experience. A competence assessor may assess their own competence.

For referral to the NHS Health Board (e.g. for OPG) entitlement as a referrer will be conferred by the NHS Health Board in accordance with their own Employer’s Written Procedure for entitlement of duty‐holders. This might be a generic entitlement in the NHS Health Board’s Employer’s Written Procedure (for example a statement that all registered dentists are deemed to be entitled to refer patients to the NHS Health Board for all dental exposure procedures), or by a separate letter of entitlement to each dentist from the NHS Health Board.

In conferring this referral entitlement, the NHS Health Board should take due account of the need to ensure that such referrals will only be accepted and justified by an NHS Health Board practitioner on the understanding that a competent clinical evaluation will be made and recorded. With regard to the previous paragraph, this should be stated by the NHS Health Board either in the letter of entitlement or, where generic entitlement applies, in the NHS Health Boards relevant Employer’s Written Procedure.

For completeness, the dental practice should indicate to the NHS Health Board, the arrangements for ensuring that a competent clinical evaluation shall be made and recorded by an operator who has been so entitled by the practice employer, either by name or generically, (e.g. confirmation that all registered dentists at the practice are competent and have been entitled by the practice employer to carry out clinical evaluation on all dental images including OPGs). In this regard, while the NHS Health Board can take no responsibility for the competence of the clinical evaluation of these images, the Health Board might retain the right to include a check on whether these images are being properly evaluated in their provisions for clinical audit under the Regulations.

Each practice owner must also appoint a Medical Physics Expert, the scope of entitlement for whom should be to provide any necessary expert advice for all types of dental exposure carried out within the practice.

3.4 Employer’s Written Procedure for entitlement of duty holders The provisions described above are reflected in the sample Dental Employer’s Written Procedure EP1 and its appendices, which accompany this explanation guide. This also includes examples of required qualifications, training, and experience.

4. Training

Under IR(ME)R Regulation 11(1), no operator or practitioner shall carry out a dental exposure or any practical aspect without first having been adequately trained. Under IR(ME)R referrers do not need additional training on radiation protection, but will be expected to have up to date training on new techniques and technologies e.g. specific training on CBCT (as recommended within HPA‐CRCE‐ 010 9 ).

IR(ME)R also requires (Regulation 4(4)a) that the employer take steps to ensure that every practitioner or operator engaged by them is adequately trained to undertake all of their duties. This includes undertaking continuing education and training after qualification (Regulation 4(4)b). For example, in the case of clinical use of new techniques, this might include training related to these techniques and the relevant radiation protection requirements.

It is important that practitioners and operators maintain their competence for each duty for which they are entitled. If competence cannot be maintained for any reason, then consideration should be given to either undertaking further training or removing the task from their scope of entitlement. Where appropriate, a review of scope of entitlement should form part of an appraisal process.

When justifying an exposure appropriate weight must be given to the following

IR(ME)R requires special attention to be given during the justification of any dental exposure that is undertaken for either medico‐legal reasons (Regulation 6(3)a) or for research when there is no direct benefit to the patient (Regulation 6(3)b).

For dental treatments where it is known in advance that a series of radiographs will be required e.g. for root canal treatment, a protocol may be written that describes when the radiographs will be taken. Therefore documenting ‘root canal’ within the patient’s dental notes prior to the treatment will demonstrate authorisation for the series of exposures.

Where specific circumstances, such as the need for an unplanned radiograph due to a complication mid‐ procedure, dictate that it might not be in the best interests of the patient for a practitioner to carry out authorisation in advance of an exposure, authorisation of the exposure must occur as soon as practicable thereafter. A note detailing the deviation from accepted practice should be included in the patient’s notes.

Suggested dental practice provisions for justification and authorisation have been outlined in dental Employer’s Written Procedure EP3.

6. Optimisation

Every dental exposure must be optimised to ensure that the radiation dose arising from the exposure is kept as low as reasonably practicable (Regulation 7(1)). This is the responsibility of both the practitioner and operator in their respective roles. Even though the radiation doses associated with dental images are usually very low, these exposures still need to be optimised.

Matters which may help ensure optimisation include the following; however this list is not exhaustive: a) When purchasing new equipment or introducing new techniques, consideration should be given to the resultant dose to the patient b) If using film, ensure that a fast film or film screen combination is utilised e.g. E‐speed or faster for I/O film; effective speed ≥ 400 for any extra‐oral film/screen combination c) All practitioners and operators are adequately trained to perform the tasks for which they are entitled d) Practitioners and operators undertake regular and relevant CPD and training after qualification e) Protocols are written to ensure that the minimum number of exposures are taken to answer the clinical question f) The correct settings are used to ensure that the dose is as low as reasonably practicable g) The correct collimation used to ensure that the dose is as low as reasonably practicable h) Images should be scored using the 1, 2, 3 system or for CBCT the 1, 2 system to monitor image quality. This may highlight any issues

IR(ME)R ‐ Regulation 6(2) Consider a The specific objectives of the exposure What How will^ is^ to it^ bechange^ gained the^ by management^ carrying^ out theof the^ exposure? patient? b The characteristics of the individual involved Such patient^ as^ age^ or^ individual^ dental^ history^ of^ the

c The individual^ potential from thediagnostic exposure^ benefits^ to^ the

What is the expected benefit of the dental exposure? Have they already had an radiograph which could provide the required information? d The detriment the exposure may cause What radiation^ is^ the dose?^ possible^ detriment^ from^ the^ associated

e

The efficacy, benefits and risk of available alternative techniques having the same object but involving no or less exposure to radiation

What other examinations are available that could answer the diagnostic question but involve no or less exposure to radiation?

i) Audit of image quality j) Implementing dental DRLs where possible

Critical examination of newly installed equipment, acceptance testing and regular equipment quality assurance are also ways to ensure that examinations are optimised, these are covered under IRR99.

IR(ME)R also calls for special attention for optimisation to be given to any medico‐legal exposure (Regulation 7(7)a) and to exposures to children (Regulation 7(7)b). Although not defined in law, an example of special attention may be having specific protocols in place for paediatric and medico‐legal dental exposures.

7. Research

Although not common within dental practices, IR(ME)R places additional obligations relating to research exposures. These are listed below and, if research is undertaken within a dental practice, must be addressed within the employer’s procedures. (See Dental Employers procedures EP14) a) All research must have been approved by an ethics committee (Regulation 6(1)c) b) All individuals must participate voluntarily (Regulation 7(4)a) c) Individuals must be informed of the risks of the radiation exposure in advance (Regulation 7(4)b) d) Dose constraints must be set down in the employers procedures for individuals whom no direct medical benefit is expected (Regulation 7(4)c) e) Individual dose targets are planned when the individual is expected to receive a diagnostic benefit (Regulation 7(4)d)

A dose constraint is a restriction on the total dose of a research study that is not expected to be exceeded. The constraint is based on the total dose from all radiodiagnostic procedures included in the research protocol. A dose target is target level of dose set before research exposures begin, in this way, excessive doses should be avoided.

8. Medico‐Legal

Medico‐legal exposures are defined in Regulation 2 as an examination performed for insurance or legal purposes without a medical indication. An example of this may be a dental radiograph following an assault where compensation is being claimed and the radiograph is not required as part of the persons diagnosis or treatment.

IR(ME)R has additional obligations associated with medico‐legal exposures which are listed below. If medico‐ legal exposures are undertaken within a dental practice an employer’s procedure is required (See Dental Employer’s Written Procedure EP15). a) The practitioner when justifying the exposure shall pay special attention to medico legal exposures (Regulation 6(3)a) b) The practitioner and operator shall pay special attention to the need to keep doses arising from medico legal exposures as low as reasonably practicable. (Regulation 7(7)a)

9. Occupational Health Surveillance

Occupational heath surveillance exposures as defined in Regulation 2 are those associated with the medical surveillance exposure for workers. An example might be a dental radiograph prior to working on an oil rig where there are no dental provisions although the patient may be asymptomatic at the time. If these types of exposure are undertaken then for clarity and completeness they could be reflected within a written procedure. (See Dental Employer’s Written Procedure EP15)

carried out by the RPA on a 3 yearly basis. An example of how exposure factors and related doses might be recorded and compared with DRLs is in Appendix 5.

In Table A5.1, (Appendix 5), Columns 3, 4, 5 and 6 are the exposure factors, and Column 7 the ‘Focus to Skin Distance (FSD)’ or ‘Focus to Film Distance (FFD)’ set and recorded by the RPA at the 3 yearly equipment assessment for each of the listed ‘examinations’. Column 8, the ‘Reference dose’ is the dose measured by the RPA for these settings.

If these standard exposure factors are then used by the operator for the examination in question, and the film is acceptable, then there should be reasonable confidence that the ‘reference dose’ is the dose being delivered to the patient, and hence, by comparison with Column 9, the DRL is not being exceeded. However, if, during the period between machine assessments, it is found necessary to alter exposure factors to achieve acceptable image quality, then a reassessment of the doses to the patient will be necessary.

As a further check, if a stepwedge is carried out regularly and is within tolerance then it can be assumed that the x‐ray machine and processor are both working correctly. If the stepwedge is out of tolerance and the chemistry is proven to be correct, then consideration should be given to carrying out further tests on the radiographic equipment.

For CR/DR the resultant image may include a Sensitivity/Exposure Index or graph. This information can be compared with the manufacturer’s recommendations which will give an indication of how much radiation has reached the detector. If the information displayed on the image is higher or lower than recommended, too much or too little radiation is being used. If too little radiation is being given then the resultant image may also be grainy in appearance.

Care must be taken when using CR/DR as the image will appear diagnostic even when too much radiation is used. This is especially true if no exposure index/graph is displayed.

If it can be demonstrated that a DRL has been unexpectedly exceeded, it should be documented along with any extenuating circumstances. Where DRLs are consistently exceeded it should be reported to the employer for investigation. Once an investigation has taken place any necessary corrective action must be implemented. (An occasional exceedance due to a change in exposure factors to accommodate special circumstances such as unusual patient anatomy should be recorded but does not require investigation.)

The procedure for establishing and using DRLs, along with the process of investigation needs to be documented (See Dental Employers procedures EP7).

11. Clinical Evaluation

Every dental exposure must have a documented report or clinical evaluation. If it is known prior to the exposure that no clinical evaluation will occur, the exposure cannot be justified and cannot lawfully take place (IR(ME)R Notes for Guidance Regulation 7(8)).

Clinical evaluation is considered to be one of the practical aspects of an exposure, and is therefore an operator function. The Employer’s Written Procedures must make it clear where this evaluation is to be recorded e.g. in the patients dental record, and how the entitled operator undertaking this task can be identified. (See Dental Employer’s Written Procedure EP8). In most cases the dentist will be the operator for clinical evaluation.

12. Incidents and near misses involving ionising radiation

It is a requirement of the legislation that when an employer knows or has reason to believe that the radiation dose given to a patient is ‘much greater than intended’ (MGTI), it must be investigated and if necessary be reported to the appropriate authority (Regulation 4(5). For conventional dental radiographs, an exposure MGTI is defined in HSE Guidance document PM 77 ‘Equipment used in medical exposure ‘as one where the

dose is at least 20 times that intended. For other procedures such as CBCT see HPA‐CRCE‐ 010 or consult your RPA and/or MPE.

Incidents involving dental radiation exposures can occur for several reasons. They may be due to an equipment fault, human error or a procedural failure. Incidents should be internally reported and investigated. Following a preliminary investigation, if it is found that a given exposure was MGTI then this would require external reporting to the appropriate authority. The authority will vary depending on the cause of the incident External reporting could be to either‐

o SM for all incidents, excluding those due by equipment malfunctions. These include when the wrong patient is x‐rayed or there has been a failure to follow Employer’s Written Procedures. (IR(ME)R) o HSE, for incidents caused by equipment malfunctions (IRR 99)

Ideally all near miss incidents should follow the same pathway, as any lessons learnt can be applied and have the potential to prevent an actual incident from occurring. The process of investigation of incidents and near misses, including responsibilities and timescales may be laid out within Employer’s Written Procedure, although this is not required under legislation. Then should a radiation incident occur the process of investigation will be standardised. (See Dental Employer’s Written Procedure EP10)

13. Clinical Audit

Clinical audit is a requirement under IR(ME)R Regulation 8. It includes a review of dental radiological practices which seeks to improve the quality and outcome of patient care. This can be done through a structured review which might lead to a modification of practice or the application of new practices where necessary. The Employer’s Written Procedures should include provision for carrying out clinical audit as appropriate. (See Dental Employer’s Written Procedure EP13)

Clinical audit might include: a) Review of image quality monitoring (1, 2, 3 or for CBCT 1, 2 scorings). These should be reviewed to see if there are any issues which may highlight training requirements b) Review of images, by multiple persons where possible, to agree levels of quality c) Dose audit d) An audit of dental records to ensure that each dental exposure has been referred, authorised and clinically evaluated in line with the written procedures and that the duty holders are identifiable e) An audit to check that entitlement of staff has taken place and that it is supported by appropriate training and CPD when necessary f) Audit of the patient identification process to ensure that each operator is following the correct procedure

14. Quality Assurance

Quality assurance (QA) as defined in IR(ME)R Regulation 2 refers to the provision and maintenance of the Employer’s Written Procedures and protocols (see Dental Employer’s Written Procedure EP12). It does not refer to equipment QA which is covered by IRR 99 or IRR (NI) 2000.

Document QA entails ensuring that the Employer’s Written Procedures and protocols comply with a document control system where the document author, version number, issue date, review date etc are clearly identified , and that the document are reviewed by the review date.

IR(ME)R (Schedule 1(e)) requires that there shall be an Employer’s Written Procedure outlining what QA under IR(ME)R is to take place, who is responsible for carrying it out, how often documentation is reviewed and, importantly, how the employer knows this has taken place.

References

  1. Ionising Radiation (Medical Exposure) Regulations 2000 http://www.opsi.gov.uk/si/si2000/uksi_20001059_en.pdf
  2. Ionising Radiation (Medical Exposure) (Amendment) Regulations 2006 and 2011 http://www.opsi.gov.uk/si/si2006/uksi_20062523_en.pdf http://www.legislation.gov.uk/uksi/2011/1567/regulation/2/made
  3. Ionising Radiations Regulations 1999 http://www.england‐legislation.hmso.gov.uk/si/si1999/19993232.htm
  4. Medical and Dental Guidance Notes http://www.ipem.org.uk/ipem_public/article.asp?id=0&did=49&aid=628&st=&oaid=‐ 1
  5. Guidance notes for dental practitioners on the safe use of x‐ray equipment http://www.hpa.org.uk/web/HPAwebFile/HPAweb_C/
  6. Guidance on the Safe Use of Dental Cone Beam CT http://www.hpa.org.uk/Publications/Radiation/CRCEScientificAndTechnicalReportSeries/HPACRCE010/
  7. Guidance and good practice notes for IR(ME)R http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_ 064707.pdf
  8. Faculty of General Dental Practitioners “Selection Criteria for Dental Radiography” http://www.fgdp.org.uk/content/publications/selection‐criteria‐for‐dental‐radiography.ashx
  9. British Orthodontic Society’s – Orthodontic Guidelines http://www.bos.org.uk/index/booksguides/radiographyguidelinespp
  10. SEDENTEXCT Cone Beam CT for Dental and Maxillofacial radiology : evidence based guidelines http://www.sedentexct.eu/files/guidelines_final.pdf
  11. General Dental Council Scope of Practice http://www.gdc‐ uk.org/Newsandpublications/Publications/Publications/ScopeofpracticeApril2009%5B1%5D.pdf
  12. IPEM ‐ Guidance in the Establishment and Use of Diagnostic Reference Levels for Medical X‐ray Examinations Report 88 http://www.ipem.ac.uk/publications/ipemreports/Pages/GuidanceontheEstablishmentandUseofDiagnosti cReferenceLevelsforMedicalX‐RayExaminations.aspx
  13. Guidance on the establishment and use of “Diagnostic Reference Levels” (DRLs) as the term is applied in the Ionising Radiation (Medical Exposure) Regulations 2000 http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_ 074099.pdf
  14. Doses to Patients from Radiographic and Fluoroscopic X‐ray Imaging Procedures in the UK ‐ 2005 Review http://www.hpa.org.uk/Publications/Radiation/HPARPDSeriesReports/HpaRpd029/
  15. Recommendations for the Design of x‐ray facilities and the Quality Assurance of Dental cone Beam CT Systems http://www.hpa.org.uk/Publications/Radiation/HPARPDSeriesReports/HPARPD065/
  16. National Reference doses for dental cephalometric radiography http://bjr.birjournals.org/cgi/gca?sendit=Get+All+Checked+Abstract%28s%29&gca=84%2F1008%2F

Appendix 1

The following statements describe some key requirements of IR(ME)R that could be considered for inclusion in the Radiation Protection File, if they are relevant and reflect local practice.

IR(ME)R statements For the XXXXX Dental Practice, (named person) is the employer for the purposes of IR(ME)R

The employer will ensure that all of the Employer’s Written Procedures and protocols required for compliance with IR(ME)R are provided and are authorised by (named person) on behalf of the employer, and are subject to a written procedure for document quality control.

Entitlement of duty holders at XXXXX Dental Practice, will be carried out by (named person), on behalf of the employer (if a different person)

The employer will ensure that all referrers to the XXXXX Dental Practice are provided with appropriate referral criteria

Responsibility for the task of maintaining a record of training of duty holders under IR(ME)R (including other staff carrying out procedures within the dental practice’s premises) will lie with (named person(s))

A Medical Physics Expert shall be appointed and entitled to be involved as required for consultation on optimisation, including patient dosimetry and quality assurance, and to give advice on matters relating to radiation protection concerning dental exposures

The employer shall establish ‘diagnostic reference levels’ (DRLs) for dental examinations and ensure that there is a mechanism for assessment of compliance with these DRLs. Where it is known that DRLs are consistently exceeded, the employer shall set up a review, and shall ensure the corrective action is taken

The employer shall establish a procedure for the investigation of incidents which may have resulted in an overexposure of patients and for reporting such incidents to the appropriate authority (either Scottish Ministers (for IR(ME)R) or for incidents due to equipment malfunction, the HSE (for IRR 99)

Entitled practitioners and operators must comply with the employer’s procedures. For the avoidance of doubt, where a person acts as employer, referrer, practitioner and operator concurrently (or in any combination of these roles) he shall comply with all the duties placed on employers, referrers, practitioners or operators under these Regulations accordingly

All practitioners and operators, to the extent of their respective involvement in a dental exposure, shall ensure that doses arising from the exposure are kept as low as reasonably practicable consistent with the intended purpose

Responsibility for maintaining an inventory of all radiation equipment used at the XXXXX Dental Practice lies with (named person)

The document authoriser is responsible for ensuring that the document is reviewed within the required period and for recording completion of each review (irrespective of whether the document is amended or not)

Appendix

-^ Example

of

a^

Guideline

issued

by

a^

practitioner

Adults

(over

years

of

age)

Type

of

dental

exposure

Clinical

indication

Individual

characteristics

Alternative

techniques

involving

less

or

no

radiation

Effective dose

(mSv)

Intra

oral

radiograph

(bitewing/periapical)

^

Assessment

of

Caries

^

Clinical

suspicion

of

retained

root

^

Clinical

suspicion

of

unusual

anatomy

Minimum

frequency

for

radiograph

to

assess

caries

following

a^ clinical

assessment

^

High

risk

–^

6 months

^

Moderate

risk

–^

months

^

Low

risk

–^

approximately

year

intervals

^

For

indications

other

than

caries,

no

dental

radiograph

within

the

last

years

N/A

Page

of

JUS

Example

Guidelines

for

the

authorisation

of

dental

radiographs

XXXXX

Dental

Practice

Issue Date:01/01/

Version No.

Issued and Authorised by

Signature of a Dentist

Author

A Practitioner

Review date:01/01/

Page

1 of 1

Appendix

-^ Example

of

Dental

Written

Protocols

Adults

(over

years

of

age)

Type

of

dental exposure

Clinical

indication

Comments

OPG

Unusual

eruption

patterns

Unusual

morphology

Extensive

and

general

periodontal

breakdown

Whole

mouth

is required

Impacted

teeth

on

one

side

Select

setting

that

includes

the

side

required

only

Delayed

eruption

Unexplained

missing

teeth

Limit

the

area

of

the

jaw

imaged

to

the

minimum

area

required

Assessment

of

wisdom

teeth

prior

to

planned

surgical

intervention

Select

setting

to

cover

the

wisdom

teeth

and

not

the

whole

mouth,

unless

specifically

requested

Children

(up

to

the

age

of

years)

Type

of

dental exposure

Clinical

indication

Comments

OPG

Unusual

eruption

patterns

Unusual

morphology

Limit

the

area

of

the

jaw

imaged

to

the

minimum

area

required

Delayed

eruption

Unexplained

missing

teeth

Limit

the

area

of

the

jaw

imaged

to

the

minimum

area

required

Prior

to

orthodontic

treatment

for

assessment

of

developing

dentition

when

patient

is aged

‐^13

years

Image

dentition

image

only

–^

no

condyles

Page

of

PRO

Example

Protocols

for

dental

radiographs

XXXXX

Dental

Practice

Issue Date:01/01/

Version No.

Authorised by

A Person

Author

A Person

Review date:01/01/

Page 1 of 1