Doc menu

1) IR(ME)R – Employers Procedures

Schedule I
The term ‘‘‘Employer ”in IR(ME)R  means any natural or legal person who, in the course of a trade, business or other undertaking, carries out (other than as an employee), or engages others to carry out, medical exposures or practical aspects, at a given radiological installation’ (SI 2000 No 1059).
It is important to recognise that the IR(ME)R Employer relates to health and safety functions rather than employment matters.
The Employer should be considered to be the Chief Executive Officer unless an alternative individual has been formally designated but should be of sufficient seniority and normally at board level.
“Employers Procedures” as required under the Regulations and provision of these is the responsibility of the Employer. IR(ME)R includes a list of procedures required as a minimum in any radiological installation. It is imperative that roles and responsibilities are clearly set out in procedures and that everyone understands their individual role. In some cases, the Employer is the same person as the practitioner and/or the operator (e.g. dental practitioners). Such an individual is still required to establish the procedures required by this Regulation and to comply with them.

Here are the Schedule 1 procedures:

  1. correct identification of the individual to be exposed to ionising radiation
  2. entitlement to act as the IR(ME)R roles of referrer, practitioner and
  3. operator
  4. medico-legal exposures
  5. making enquiries of females of childbearing age to establish whether the individual is or may be pregnant or breastfeeding
  6. quality assurance programmes
  7. assessment of patient dose
  8. diagnostic reference levels
  9. medical research programmes
  10. information and written instructions
  11. evaluation for each medical exposure
  12. accidental or unintended doses                                                   

    (SI 2000 No 1059)

Regulation 10
This regulation requires Employers to keep an up-to-date inventory of equipment. This inventory should contain the following information -

(a) name of manufacturer,

(b) model number,

(c) serial number or other unique identifier,
(d) year of manufacture, and
(e) year of installation.

SCoR Guidance
In general terms, when producing a written procedure the following questions may help to ensure that it is written in a clear, unambiguous style:

  • What is the procedure?
  • Who is entitled to undertake this procedure?
  • How is it done?
  • When is it done (e.g. Patient ID should be undertaken in advance of an exposure
  • Why should it be done?
  • Any occasions when it should not be done?
  • Should it be reviewed and if so at what intervals?
  • Who is the person responsible for writing this procedure?

All procedures should be subject to frequent review and in the instances of updates, older procedures should be destroyed to minimise error and confusion.

SCoR Guidance - NOTE
All radiographic staff are required to be aware of who their local IR(ME)R Employer is, to read and understand their local “Employers Procedures” and to fully understand their legal responsibilities under IR(ME)R. The following specific information about the contents of “Employers Procedures” includes guidance from the Department of Health (DH) (DH IR(ME)R guidance notes, 2007) as well as SCoR guidance but it must be stated that it is the Employers responsibility to implement IR(ME)R and the employees responsibility to adhere to IR(ME)R therefore, the specific detail of local IR(ME)R Employers Procedures may differ from that described. If the procedures are not fit for purpose or are impossible to adhere to then the operators have a duty to inform the appropriate person immediately.

Schedule 1 Employers Procedures


a) Correct Identification (ID) of the individual to be exposed to ionising radiation

It is the responsibility of the operator (individual undertaking the medical exposure) to correctly identify the individual undergoing the medical exposure. It is advised that this is done by asking the patient the following questions to which there should be an active response:

  • What is your name?
  • What is your date of birth?
  • What is your address?

In the cases where the answers to these questions match those on the source document (i.e. request card or prescription sheet), there should be a procedure to identify which operator has undertaken the patient ID (e.g. operator signature) and if there is more than one operator involved in the patient exposure, which requires two signatures, the procedure should state clearly which operator is responsible for the patient ID (e.g. first signature). The use of patient ID bracelets has come into question as there may be a case of mistaken identity when the ID bracelet was first put on (local procedures should be determined to avoid this happening).

There may be exceptions where it may not be possible or more difficult for the patient to be directly identified, for example:

  • Inpatients v outpatients
  • mute or non-English speaking
  • unconscious
  • children
  • those patients unable to identify themselves but have a carer with them

Procedures for correct ID should be in place to cover these patient examples. The use of a family member as an interpreter for non-English speaking patients is not advised. In these circumstances, formal interpreter services should be used.
Patient ID checks must be preformed prior to each medical exposure or set of medical exposures.


b) Identify individuals “Entitled to act as referrer, or practitioner or operator”
 

A note about “Entitlement”
The IR(ME)R Employer has the legal responsibility for entitling individuals to act as one or more of the three duty holder roles of referrer, practitioner and operator. Being entitled by the Employer, means that permission has been given to act, in compliance with the Regulations, according to the specific responsibilities of a duty holder role. There must be a documented entitlement process, within the Employers’ procedures, that details the mechanism through which an individual becomes entitled. A specific process for checking that an individual is “adequately trained” is required before entitlement can be given to act as practitioner and / or operator. The scope of practice of an entitled individual should also be specified with procedure.

Referrers 
The Referrer must be a registered healthcare professional (a person who is a member of a profession regulated by a body mentioned in section 25(3) of the National Health Service Reform and Health Care Professions Act 2002). Decisions on who is entitled to act as a referrer should be taken at local level by agreement between the Employer and the healthcare professionals involved in medical exposures. The Employer is required to make referral criteria available to all referrers. A comprehensive named and entitled list of all non-medical referrers should be kept in all areas within the radiology department (and kept up-to date by a person designated by the Employer) – this enables the radiographer to check that they are authorised to request. The referrer is required to provide sufficient clinical information in order that the practitioner may make a decision about justifying the medical exposure (e.g. in diagnostic radiology the use of the 2007 Royal College of Radiologists “Making the best use of a clinical radiology service” 6th edition publication by the referrer is usually accepted as good practice). In radiotherapy, the referral must include as a minimum details of the tumour diagnosis, histology, clinical findings and staging examinations. For referral to radiotherapy planning the Employer should define appropriate referral criteria which would normally include histology reports and some diagnostic imaging. This might be different in the case of an emergency referral such a cord compression where histology might not be appropriate. A local procedure should make allowance for emergency patients or particular national guidelines. Referral criteria also need to be in place for verification images.
 
SCoR Guidance
Although it is not a legal requirement within the Regulations, that medical / non-medical referrers are trained, it is normal practice that radiology departments require them to attend radiation protection/ IR(ME)R awareness training prior to being entitled to act as referrer. Guidance has been written by SCoR, and other professional bodies (RCN, 2008) to help those non-medical healthcare practitioners (including radiographers) registered with a healthcare regulatory body who wish to take on the role of IR(ME)R “Referrer” within a clinical imaging department.
The guidance is available at: 
https://www.sor.org/learning/document-library?title=clinical+imaging+req...
The guidance sets out a policy position on handling this type of request which was agreed by all the contributing organisations (including the HPA) and includes legal and professional requirements under IR(ME)R. The IR(ME)R Referrer is required to have knowledge of IR(ME)R and radiation exposure risks. Following this publication the College of Radiographers developed an “IR(ME)R awareness training study day for Nurses and Allied Health Professionals”. Similar training is generally available within local clinical imaging departments.

The Welsh Scientific Advisory Group which advises the Welsh Assembly Government has produced an excellent guidance publication on “non medical / dental referral for diagnostic investigation”

Referral protocols should be in place for the different groups of medical and non-medical referrers which could contain details relating to the minimum educational requirements. Named lists of referrers should be kept and be updated as and when appropriate.

SCoR Guidance
Electronic referrals

There may be some radiology management systems (RMS) / radiotherapy verification systems that allow electronic IR(ME)R referrals. The referrers’ signature is normally their individual log on ID (name or code) and the sharing of usernames and passwords must be strictly prohibited.

The SCoR Information Management and Technology (IM&T) Group have provided the following advice by way of helping to ensure that the use of a Radiology Management System (RMS) / Radiotherapy Verification system (known as “system”) can provide a safe and robust IT system to aid in electronic image requesting / radiotherapy referral:
 

  • There must be a facility for recording the priority of the request
  • The system must contain features, which provide the implementation and monitoring of compliance with the IR(ME)R.  The system must capture all necessary data items necessary to comply with the Regulations.
  • The system must provide a field for authorisation of examination / treatment procedures by the IR(ME)R Practitioner/operator.
  • The system should be able to provide appropriate information regarding LMP dates / pregnancy status.
  • There must be a facility, supported by a drop down box (or comments box), which allows the user to indicate why a request / referral has not been justified / refused.
  • The system administrator must be able to define the appropriate IR(ME)R roles (referrer, practitioner and operator) for all users and all examination combinations to conform to local IRMER procedures.
  • The system needs to include an up-to-date register of referrers with their current Registration details.
  • The RMS must implement appropriate permissions at all stages of the requesting/appointing/imaging/reporting process (diagnostic only).
  • The RMS must be able to produce IRMER audit reports to demonstrate compliance (diagnostic only).  
  • The RMS must record the electronic ‘sign off’ of reports in order that an audit trail can be detailed which confirms that clinicians have received reports (diagnostic only).

Practitioners
The Practitioner must be a registered healthcare professional (i.e. a person who is a member of a profession regulated by a body mentioned in section 25(3) of the National Health Service Reform and Health Care Professions Act 2002). The practitioner must be entitled by the Employer and may be based on the type of medical exposure/radiotherapy treatment and on specific circumstances. It may be appropriate to agree that certain non-medical health professionals can act as a practitioner for diagnostic/radiotherapy procedures depending upon the complexity of the examination/treatment. In clinical imaging, practitioners are normally radiologists, specialist registrars, radiographers, ARSAC certificate holders (in nuclear medicine) and dental practitioners for intra-oral or panoramic dental radiology. In radiotherapy, practitioners are normally clinical oncologists and specialist registrars / radiographers for certain procedures. The practitioner must be “adequately trained” as detailed in Schedule 2 of the Regulations to undertake the role. The primary responsibility of the practitioner is to justify medical exposures – to do this the request must be assessed using the clinical data supplied by the referrer. Justification is the process of balancing the potential benefit of the exposure against the potential detriment from the exposure to that individual in making a decision in the best interests of the individual. This requires the practitioner to have a full knowledge of the potential benefit and detriment associated with the medical exposure under consideration.

SCoR Guidance
The requirements of Schedule 2 of IR(ME)R are largely addressed by specific professional qualifications and experience. The exception to this may be where individuals undertake functions associated with role development and extension, in which case the contents of Schedule 2 must be addressed and evidence of this should be available before entitlement is extended.
The Employer should specify the scope of practice for which an individual can act as practitioner (e.g. in the case of radiographers this may mean justification for all plain film and some CT procedures or for radiotherapy planning/verification exposures). Training must be provided when equipment changes, new techniques or protocols are introduced. All training records must be written and kept up to date.

Concomitant doses in radiotherapy - Concomitant exposures are defined as all exposures within a course of radiotherapy other than the treatment exposures. These will include simulation, check simulation, computed tomography (CT) localisation and portal localisation and verification images (when these are additional to the treatment exposure).
The IR(ME)R practitioner responsible for the treatment exposures can justify the concomitant exposures at the outset or during the radiotherapy course, but in doing so must be aware of the likely exposures and the resulting dose so that the benefit and detriment can be assessed. This can be achieved by including likely concomitant exposures within site specific protocols with a total effective dose agreed. The IR(ME)R practitioner for the treatment exposures need not be the same practitioner for the concomitant exposures.
Therefore, the practitioner should be aware of the concomitant doses received by the patient as part of a course of radiotherapy in order to make that judgement. This could be achieved through written site specific protocols that include doses for concomitant exposures and limits to those exposures. This will be department specific according to the localisation and imaging procedures.

Operators
The operator does not have to be a registered healthcare professional but is required to be adequately trained for their scope of practice as detailed in Schedule 2 of the Regulations. The definition of operator is stated in IR(ME)R as ‘any person who is entitled, in accordance with the Employer’s procedures, to carry out practical aspects’ (SI 2000 No 1059). The Employer should specify the scope of practice and the tasks for which an individual can act as an operator and be able to demonstrate that they are adequately trained to undertake these tasks. Individual training records for operators require regular updating as individuals develop, and when equipment and techniques change or are introduced. Operators are legal duty holders who are entitled to carry out practical aspects of a medical exposure. Practical aspects include the physical conduct of the exposure and other supporting aspects that have an influence on radiation dose to the patient.

Operators may include:
-    Radiographers 
-    Qualified Radiography Assistant Practitioners
-    Dosimetrist / Physicist / Clinical Technologists
-      Nurses
-     Healthcare professionals (including doctors and physiotherapists who carry out a clinical evaluation on images for which they may have acted as the referring clinician and who then act on their findings. This is part of the practical aspect of the examination)

Third party service engineers would not normally be considered as operators. Where significant changes to equipment have been made, these should be checked where practicable by an operator (e.g. a medical physicist) before equipment is brought into clinical use.

SCoR Guidance
Persons entitled to act as an Operator must have undergone training in those subjects in Schedule 2 of IR(ME)R which are relevant to their functions and area of practice.  SCoR advise that, whilst possible under legislation, student radiographers and trainee assistant practitioners are not entitled as Operators. It is appropriate for them to operate equipment provided that they are supervised by a trained and entitled operator (Regulation 11(3) of IR(ME)R) see SCoR guidance on students and trainees being entitled as an operator at https://www.sor.org/learning/document-library/student-radiographers-trai...
If an Employer entitles a student radiographer or trainee assistant practitioner as an “Operator”, there must be a robust local entitlement process within the clinical department which satisfies the relevant sections of Schedule 2. As part of the entitlement process, the necessary information surrounding the individual’s (student/trainee) scope of practice, the theoretical and practical training given as well as an assessment of competence must be clearly documented in the individual’s training record in line with the IR(ME)R Employer’s Procedures. The Employer then assumes responsibility for ensuring that adequate and up-to-date local training of the entitled Operator is delivered and recorded, and is consistent with the tasks the individual is entitled to carry out.

This category of exposure within a clinical imaging department includes those required for legal purposes of any kind (e.g. those required in connection with legal proceedings, for insurance purposes and those required prior to emigration without a medical indication).
The referrer for a medico-legal exposure is normally a medical practitioner but, SCoR advise that a radiographer may act as practitioner for certain examinations (e.g. pre-immigration chest X-ray; pre-employment chest X-ray). It is the responsibility of the referrer to provide the previous medical history of the patient (Regulation 5 (5)  but a double of check previous medical exposures, by reference to the department records, is advisable to ensure that the individual has not already undergone the examination as part of routine clinical management to avoid unnecessary repeat exposures.
The procedure is only justified if it is not possible to use alternative techniques which have less or no ionising radiation.


d) Females of childbearing age - to establish whether the individual is or may be pregnant or breastfeeding

Clinical imaging and radiotherapy can cause damage to an unborn child (fetus), therefore it is essential that the pregnancy status is determined prior to any relevant medical exposure. Radiation risks are related to the stage of the pregnancy and the absorbed dose to the fetus.

Diagnostic Radiography
A jointly authored updated guidance booklet entitled “Protection of Pregnant Patients during Diagnostic Medical Exposures to Ionising Radiation” (2009) written by HPA, SCoR, and RCR about patients of childbearing age is essential reading for all diagnostic radiographers.

SCoR Guidance
The IR(ME)R procedure should be aimed at all females of childbearing age, for X-ray examinations between the diaphragm and knees, for radionuclide imaging studies and radiotherapy treatment. The age guidance is normally set between  12 and 55 years (this is the standard usually employed although it is not legally enforceable) but a local procedure should be in place for dealing with the sensitive issue of potential pregnancy with younger female patients (e.g. from 9 years of age) and for female patients who are unconscious. Flow chart examples for diagnostic radiography (conscious and unconscious patients) are detailed in Appendix.
Firstly, it is the responsibility of the referrer to investigate the pregnancy status of females who are to be referred for medical exposure using ionising radiations. The “pregnancy status” must be written on the request card etc. It is the responsibility of the operator to again check the pregnancy status before the examination / treatment. If more than one member of staff is involved in the medical exposure, the operator who initiates the exposure must be certain that the procedure for the investigation of pregnancy status has been carried out. Notices should be displayed in the clinical imaging / radiotherapy department requesting patients that they inform staff if they are or might be pregnant.

Limitations of pregnancy testing
Due to the potential for a high rate of false negatives achieved during early pregnancy, the use of pregnancy testing should not be considered as conclusive evidence that a patient is not pregnant.

Therapeutic Radiography
SCoR Guidance

See guidance for diagnostic also. Often a pregnancy status check in radiotherapy aims to cover the entire radiotherapy process in order that the patient is not repeatedly asked about their pregnancy status. However, there must be some consideration given to the timing of the declaration as there may be a significant time period between declaration and localisation/treatment that the pregnancy status may have changed. Local policies must take into account any potential for change.
There must be documented evidence that a discussion has taken place regarding pregnancy which must be available for staff to check/refer to. It is advised that all women of child bearing age should sign a pregnancy status form to confirm that they are not pregnant, before their first exposure.
The majority of patients receiving external beam radiotherapy will require localisation therefore the “Pregnancy Flow Chart” for diagnostic procedures (Appendix) may be followed if it is necessary to re-check the pregnancy status of patients.
Prior to delivery of radiotherapy, staff must be confident that a patient is not pregnant and should not assume that if a patient was not pregnant at localisation, then they will not be pregnant at treatment. A declaration either as part of the consent process or undertaken separately should be verified taking into account the date of consent/declaration. Local procedure should provide specific detail on the “pregnancy status checking” procedures.  There should be a procedure if a patient informs an operator that she has become pregnant during treatment – in the first instance, no further treatment should be given until the clinical oncologist has been informed who will then decide with the patient, the efficacy of further radiotherapy (liaising with the Medical Physics Expert as necessary).

Delivering Radiotherapy to a Pregnant Patient – SCoR Guidance
A pregnant patient requiring external beam radiotherapy must be fully aware of the potential risks to the fetus and consent to treatment prior to any intervention being undertaken must be verified.
It is essential that a full risk assessment involving the clinician, therapeutic radiographers/ dosimetrists and the medical physics expert is undertaken, the aim of which is to estimate the dose to the fetus and to determine whether the dose can be reduced through modifications to the treatment plan / shielding.
Prior to the pregnant patient starting treatment phantom measurements must be undertaken with and without shielding. The treatment plan should be reviewed to determine whether any modifications would reduce the dose to the fetus.
Shielding to the abdomen to minimise the dose further might be required, the design of which will be specific to the individual patient. It is essential that the shielding is safe and robust.  During treatment, dosimetric measurements could be obtained to confirm the dose to the fetus (vaginal vault) and other areas as required. There must be a record of the shielding configuration and dosimetry results.

SCoR Guidance (not relating to IR(ME)R) - Fertility following examinations

Nuclear Medicine
Male patients should not father a child for up to 6 months after their radioiodine therapy date and this advice must be included in the radioiodine therapy information leaflet that is given to all patients.

Therapeutic Radiography
The issue of fertility should be discussed between the clinician and patient before radiotherapy procedures are begun; patients may, if there is a risk of infertility, wish to have eggs or sperm banked before commencing treatment.


e) Quality assurance programmes

IR(ME)R defines quality assurance as, ‘any planned and systematic action necessary to provide adequate confidence that a structure, system, component or procedure will perform satisfactorily and safely complying with agreed standards and includes quality control’ (SI 2000 No 1059). Regulation 4(3) (b) states that quality assurance programmes are required for standard operating procedures – this is not about equipment which is dealt with under IRR 1999. All procedures should be regularly reviewed to ensure that they are effective and appropriate and to identify any necessary amendments. To ensure that the QA programme is being followed, a system of regular audits is essential, and to undertake this, an IR(ME)R implementation group may be set up within clinical imaging departments with the remit to review IR(ME)R procedures, to audit implementation and to report any failure. This implementation group must undertake a rolling programme of audit of implementation of the IR (ME) R procedures.

SCoR Guidance
Therapeutic Radiography

The requirements for QA in radiotherapy departments are likely to be fully met by an ISO9001 quality system but such a system is not an essential requirement. Compliance with IR(ME)R is a statutory requirement and it is the responsibility of the Employer to ensure that there is a set of written procedures in place to which the duty holders must then adhere. A quality management system (e.g. QART) can help compliance with IR(ME)R, but it must be clear which parts of the documents are intended to form part of the IR(ME)R procedures. For further details see pages 33-35 of the 2008 jointly authored publication entitled “A Guide to Understanding the Implications of the Ionising Radiation (Medical Exposure) Regulations in Radiotherapy” written by RCR, SCoR, IPEM, and HPA.

f) Assessment of patient dose

For each medical exposure the dose of ionising radiation to the individual undergoing the exposure is to be kept as low as reasonably practicable (ALARP) and consistent with the intended diagnostic or therapeutic purpose. All relevant dose information for each patient exposure should be recorded.

SCoR Guidance
Diagnostic radiography
In plain film radiography the following information should be recorded by the operator on the request card to aid in exposure audits and the ongoing monitoring of exposure factors:

  1. kV and mAs
  2. Total examination dose-area product (DAP) if a DAP meter is fitted on the set
  3. If a DAP meter is not fitted and automatic exposure control (AEC) is used, giving a record of kVp and mAs for each exposure
  4. If a DAP meter is not fitted and automatic exposure control (AEC) is not used, record “std” to indicate that standard factors taken from the exposure chart were used or record kVp and mAs if non-standard exposure factors were used

For examinations involving fluoroscopy the operator should record the DAP and screening time. If a DAP meter is not fitted to the equipment the operator must record screening time
For CT scanning, information required to be recorded should include the number of slices, slice widths, kVp, and mAs. Alternatively the scanner may provide information on dose-length product (DLP) and CT Dose Index (CTDi).
For radionuclide imaging studies, the operator administering the dose must record the administered activity on the request form and sign it.
Patient dose information and typical effective doses, equivalent periods of natural background radiation and lifetime fatal cancer risks from diagnostic medical exposures is available via the HPA website at:
http://webarchive.nationalarchives.gov.uk/20140714084352/http://www.hpa....

Therapeutic radiography
For treatment purposes, tumour dose, beam energy, beam number & projections must be recorded – the use of in-vivo dosimetry is another method for the assessment of patient dose and procedures relating to this should also be included. Further information is available from the jointly authored guidance entitled “Implementing In-vivo dosimetry” written by SCoR, RCR, BIR, & IPEM & available via: https://www.sor.org/learning/document-library?title=Implementing+in+vivo...
For planning & verification purposes using simulator, kVp and mAs should be recorded; in using CT simulator (see diagnostic advice above).

g)  Diagnostic Reference Levels

Regulation 4(3)(c) of the Regulations requires that Employers establish Diagnostic Reference Levels (DRLs) and undertake appropriate reviews if they are consistently exceeded. The DH produced guidance in 2007 – available at: http://webarchive.nationalarchives.gov.uk/20130107105354/http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_074067
Further information may be obtained from “Report 88   - Guidance on the Establishment and Use of Diagnostic Reference Levels for Medical X-Ray Examinations” (2004) written by a Joint Working Party IPEM, BIR, RCR, NRPB and CoR. This report shows how diagnostic reference levels may be used as a practical tool by departments to develop quality assurance and clinical audit programmes in order to comply with the legislation.
DRLs are used for the following purposes:

  1. To determine whether the doses to patients are kept as low as reasonably practicable (ALARP)
  2. To provide a feedback mechanism for generic justification protocols to ensure that the exposure of patients to radiation are compatible with the assumptions made by the practitioner responsible for the generic justification
  3. To provide a feedback mechanism for practitioners conducting high dose interventional procedures to indicate whether there may be a risk of exceeding the threshold dose for deterministic effects

DRLs are set for a sufficient number of common diagnostic radiological procedures so that relevant DRLs are available for examinations for every piece of diagnostic X-ray equipment. Local DRLs should be established with the support of the Medical Physics Expert (MPE). In the absence of adequate audit data, national or European DRLs should be used.
Regulation 4(6) requires ongoing review of local DRLs and the evaluation of the reasons why DRLs may have been exceeded. Corrective action might include setting new values for DRLs

SCoR Guidance
Therapeutic Radiography
IR(ME)R does not require DRLs to be set for radiotherapy planning but the principle of ALARP must still be applied and the implementation of DRLs is good practice which radiotherapy departments should be moving towards.. An estimate of time and exposure rate is sufficiently accurate when concomitant exposures are compared with subsequent therapeutic exposures. A chart of typical screening times and exposures for a selection of techniques should be available as reference to the operators. CT and simulator exposures should be recorded in the patient’s record, so that any concomitant exposures may be estimated.

Interventional Radiology
IR(ME)R requires DRLs to be set for all radio-diagnostic examinations, however, interventional work tends to be mostly of a therapeutic nature and therefore does not require DRLs. For the diagnostic procedures in interventional radiology there are a broad range of doses produced due to patient size, the complexity of examinations and the variations in the technique by the operator and consequently it is difficult to establish local DRLs for common interventional procedures. Work is in progress to establish National Diagnostic Levels for the most common interventional procedures.

h)   Medical research programmes

Procedures must be in place for the use of ionising radiation for clinical research purposes to ensure that the use of ionising radiations in research are properly justified, that doses for research exposures are kept as low as reasonably practicable and to inform research subjects appropriately of the relevant risk from the radiation exposure.
The procedures should provide that:

  • the individuals concerned participate voluntarily in the research programme
  • the individuals concerned are informed in advance about the risks of the exposure
  • the dose constraint set down in the Employer’s procedures for individuals for whom no direct medical benefit is expected from the exposure is adhered to
  • individual target levels of doses are planned by the practitioner for patients who voluntarily undergo an experimental diagnostic or therapeutic practice from which the patients are expected to receive a diagnostic or therapeutic benefit (NRES, 2008).

These issues are addressed in the guidance entitled “Approval for research involving ionising radiation, Version 2 “(2008) the National Research Ethics Service [NRES])  For further information, go to: http://www.nres.nhs.uk/applications/integrated-research-application-system/

Integrated Research Application System (IRAS)
The Integrated Research Application System (IRAS) is a single online system for applying for permissions and approvals for health and social care/community research in the UK. It streamlines the process for seeking relevant approvals, as researchers no longer need to enter the details for a single project in separate application forms.

IRAS can be accessed at www.myresearchproject.org.uk

Since 1 April 2009, all applications to NHS Research Ethics Committees are made using IRAS.

Where application forms for ethical review were completed in the NRES form system or using the prior paper-based systems, IRAS includes the facility to create a minimal dataset in IRAS. This contains sufficient information to create new SSI Forms, notices of substantial amendment and ARSAC forms

i)    Information and written instructions

Regulation 7(5) requires the Employer’s procedures to include the giving of instructions and information in cases where radioactive medicinal products are administered to a patient. The instructions and information are written to aid the consent process and should specify how doses resulting from the patient's exposure can be restricted so as to protect persons in contact with the patient, set out the risks associated with ionising radiation and be given to the patient prior to leaving the place where the medical exposure was carried out.

j)  Procedures for the carrying out and recording of an evaluation for each medical exposure

Regulation 7(8) requires the Employer to ensure that a clinical evaluation of the outcome of each medical exposure is recorded and to set out in procedure, how and when this is to be done. The outcome of all exposures must be recorded and is within the optimisation requirements primarily designed to prevent unnecessary exposures being undertaken. If an exposure is not to be evaluated then it cannot be justified and therefore should not be undertaken.

SCoR Guidance
Diagnostic radiography
If the practitioner or operator knows that no clinical evaluation will be recorded, then the exposure cannot be justified and the request must not be authorised.
The evaluation of a medical exposure is via the imaging report whether as an initial report or a final report – procedures should be in place to ensure a report is produced and recorded for each medical exposure. This normally involves radiologists and radiographers (or other clinicians) recording the image report within notes or on a PACs system in a timely fashion to allow further patient management to occur.

The National Diagnostic Imaging Board (England) produced a best practice guidance entitled “Radiology Reporting Times” (2008) in which states that the Standard for turn around times in image reporting are:

Urgent Cases                            -        Immediate (within 30 minutes)
Inpatients and A&E cases         -        Same working day
All other cases                          –         by next working day

SCoR Guidance
Therapeutic radiography
Radiotherapy includes a range of medical exposures and the purposes of clinical evaluation for each of these are quite different.  All radiation treatment doses, simulation, and verification doses should be recorded in the individual patient record by adequately trained operators (oncologists and radiographers). Planning exposures (simulator or CT simulator) are evaluated by their actual use in the treatment pathway. Verification and portal imaging exposures are evaluated for correctness in beam placement.
Accumulative effect of the treatment exposures is evaluated during the course at clinic review or post treatment at follow up.

k)   Procedures to ensure the probability and magnitude of Accidental or unintended doses are reduced so far as possible.

Regulation 4(5) requires the Employer to carry out investigations of incidents and   appropriate reviews. All departments should have procedures in place to deal with this locally (e.g. independent dose checks, reporting or errors procedures).

SCoR Guidance
Patients who undergo an examination/treatment that was not intended, due to mistaken identity or other procedural failure, and were consequently exposed to radiation, should be considered as having received an unintended dose of radiation, in which case an Incident/ Near Miss Report Form 1 should be completed. See further information in Section 5 of this booklet.

Radiotherapy
Misidentification of a patient or dataset used for treatment delivery should be reported to the appropriate authority. The importance of reporting and learning from errors and near misses is discussed in the guidance document “Towards Safer Radiotherapy” written by SCoR, RCR, IPEM, BIR, HPA & NPSA (2008). . The publication is available via: https://www.sor.org/learning/document-library?title=towards+safer+radiot...
 

Content tools

Accessibility controls

Text size

AA A

Colour