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First FRCR Examination in Clinical Radiology

Statutory Requirements and Non-Statutory Recommendations

Ionising Radiations Regulations 1999

John SaundersonRadiation Protection Adviser

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Relevant Radiation Legislation• Ionising Radiations Regulations 1999

– staff, public, equipment (IRR99)

• Ionising Radiation (Medical Exposure) Regs 2000– patients, research subjects (IRMER)

• Environmental Permitting Regulations 2010– keeping & disposing of radioactive materials (RSA93)

• The Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations 2009

• Medicines (Administration of Radioactive Substances) Regulations 1978– nuclear medicine, brachytherapy (ARSAC)

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Guidance

• Approved Code of Practice (ACOP)

• Guidance Notes

• DoT guidance

• odd HSE guidance

• etc.

• IPEM, NRPB, RCR, BIR, etc. stuff.

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Ionising Radiations Regulations 1999 •Responsibility for radiation safety•Local rules and procedures•Role of radiation protection adviser and radiation protection supervisor•Classified workers•Restriction of exposure (through design, systems of work and ppe)•Dose limits•Equipment used for medical exposures•Notification of incidents•Dose constraints for comforters and carers•Routine inspection and testing of equipment•Notification of incidents .

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Responsibility for radiation safety•Radiation employer - i.e. an NHS Trust, private dentist, etc.

–Authorised practices

–Notification to HSE

–Prior risk assessments

•Employee must–not knowingly expose himself greater than necessary

–use personal protective equipment provided

–report equipment defects

–look after PPE

–(extra duties for classified persons)

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Local rules and procedures

•Controlled areas

•Supervised areas

•Local Rules.

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Controlled area• any area where it is necessary to follow special procedures to

restrict significant exposure, or

• any area where > 6 mSv/y, or 3/10th dose limit is likely

• also ACOP says if– > 7.5 uSv/h averaged over 8 h working day– > 75 uSv/h to hands averaged over 8 h working day– contamination risk– need to keep non-radiation workers out

• or > 7.5 uSv/h averaged over 1 minute and– site radiography, or

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Controlled area• any area where it is necessary to follow special procedures to

restrict significant exposure, or

• any area where > 6 mSv/y, or 3/10th dose limit is likely

• also ACOP says if– > 7.5 uSv/h averaged over 8 h working day– > 75 uSv/h to hands averaged over 8 h working day– contamination risk– need to keep non-radiation workers out

• or > 7.5 uSv/h averaged over 1 minute and– site radiography, or– employees untrained in radiation protection enter area (unless

radioactivity is dispersed inside a person).

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Supervised area• any area where it is necessary to keep conditions under

review, or• any area where > 1 mSv in a year, or 1/10th dose limit is

likely.

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Local Rules

• How to work safely in that area

• Must contain– Dose investigation levels– contingencies for foreseeable accidents– RPS name– describe area covered– work instructions for unclassified workers.

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Local Rules• Could also contain

– management and supervision of work– testing and maintenance of safety features– radiation and contamination monitoring– testing of monitors– personal dosimetry– arrangements for pregnant and breast feeding staff– risk assessments– programme to review ALARA– RPA contact.

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Local Rules• Usually get new employees to read Local Rules and

sign to say they have understood them.

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Role of radiation protection adviser

and radiation protection supervisor

R.P.A.

•Must have qualification approved by HSE (e.g. RPA2000 certificate)

•Must be appointed in writing

•Must be consulted on–controlled and supervised areas.

–prior examination of plans

–regular calibration of dose monitoring equipment

–periodic testing of safety features and warning devices

–risk assessment of new radiation work.

–incidents where more then 6 mSv has been received.

–critical examination of safety features of new radiation equipment.

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R.P.A. need not be appointed if only

• Very, small amounts of radioactive material (below specified levels)

• Very low dose (< 1uSv/h @ 10 cm) x-ray units of a design approved by HSE

• VDUs with < 1uSv/h @ 10 cm

• < 30 kV and < 1uSv/h @ 10 cm.

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R.P.S.• Must be appointed “for the purpose of securing

compliance with these Regulations” in controlled or supervised areas

• Name must be in Local Rules

• It is recommended that– know & understand regs. and local rules– command sufficient authority– understand necessary precautions– know what to do in an emergency.

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Classified workers•Anyone who may exceed 6 mSv effective dose per year, or 3/10

th of a dose limit (e.g. 150 mSv hand dose, or 50 mSv lens dose)

•Must be informed (!)

•Must be 18 or over

•Must be certified fit to work with radiation by a suitable doctor

•Dose monitored and recorded for 50 years with an HSE Approved Dosimetry Service - results to HSE

•Radiation passbook for “outside workers”

•Adequate (at least yearly) medical surveillance - record for 50 y.

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Restriction of exposure (through design, systems of work and ppe)

•Restrict exposure1. By engineering

2. By systems of work

3. By personal protective equipment

•Controlled areas - demarcate and sign

•Non-classified workers can only enter under written system of work

•Must demonstrate by personal dose monitoring or other means that doses are restricted

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Dose Limits

Schedule 4 Part 1

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• Employees 18– 20 mSv/y effective dose– 150 mSv/y equivalent dose to lens of eye– 500 mSv/y equivalent dose over 1 cm2 skin– 500 mSv/y equivalent dose to hands, forearms, feet and

ankles

• Trainee < 18– 6 mSv/y effective dose– 50 mSv/y lens of eye– 150 mSv/y over 1 cm2 skin– 150 mSv/y hands, forearms, feet and ankles .

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• Abdomen of women of reproductive capacityat work – 13 mSv / 3 months equivalent dose

• Not employee or trainee, or a “comforter or carer” or undergoing a medical exposure– 1 mSv effective dose, unless dose the result of a medical

exposure of another, then 5 mSv / 5 y– 15 mSv/y lens of eye– 50 mSv/y over 1 cm2 skin– 50 mSv/y hands, forearms, feet and ankles .

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Reg. 11(2)

(2) Where an employer is able to demonstrate in respect of any employee that the dose limit specified in paragraph 1 of Part I of Schedule 4 is impracticable having regard to the nature of the work undertaken by that employee, the employer may in respect of that employee apply the dose limits set out in paragraphs 9 to 11 of that Schedule and in such case the provisions of Part II of the Schedule shall have effect.

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• Employees 18– 100 mSv / 5y and 50 mSv/y effective dose– 150 mSv/y equivalent dose to lens of eye– 500 mSv/y equivalent dose over 1 cm2 skin– 500 mSv/y equivalent dose to hands, forearms, feet and

ankles

• Not allowed for Trainees < 18

• Abdomen of women of reproductive capacityat work – 13 mSv / 3 months equivalent dose .

Part II Dose Limits

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To use Part II must . . .

• Consult RPA

• inform employee ADS in writing

• give 28 days notice to HSE

• if > 20 mSv given in a year– undertake investigation– notify HSE

• Review every 5 years.

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Dose Limits

• Note, not like a speed limit. Doses must be as low as is reasonably practicable (ALARP)

• Dose constraints used in design– e.g. 0.3 mSv for members of public,

– 5 mSv for comforters and carers (1mSv if pregnant)

• Foetus limit: 1 mSv from notification of pregnancy by employee• Need formal investigation levels for staff• Do not apply to medical exposures.

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For HEY Trust the DIL’s are

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HSE Nov. 01

“There has been a number of reported cases where employees have failed to take good care of their dosemeters. Many of these cases involve employees in the Health Services, some of whom have been senior clinicians.

“Non-Classified employees who have been provided with a dosemeter by their employer to ensure compliance with reg 18(2)(b)(ii) of the IRR99 have a duty to look after that dosemeter and return it for processing as required. Provided the employer has informed the employees of

that duty and is exercising the appropriate level of supervision, employees who persistently fail to wear, look after or return their dosemeters promptly are liable to enforcement action by inspectors up to and including prosecution under Section 7 of the HSW Act 1974. Employers may find statement of this fact useful when dealing with 'errant' staff.”

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Equipment used for medical exposures

•Design, construct, install, maintain to keep doses ALARP

•Display indication of dose (e.g. DAP meter, mAs meter, etc.)

•Equipment quality assurance programme–IPEM91

–Must test before first clinical use

–Must test at appropriate intervals

–Must test after major maintenance.

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Routine inspection and testing of equipment

•Follow IPEM 91–Test, e.g kV accuracy

–Expertise, e.g. A = radiographer, B = medical physics

–Frequency, e.g. annual for B general

–Remedial level, e.g. +/- 10% for kV

–Suspension level, e.g. +/- 20% for kV

Notification of incidentsMust report to HSE where dose to patient is “much greater than intended” due to equipment fault.

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Patient Doses Much Greater Than Intended

[HSE PM77 (3rd)]

• x 20 - extremities, skull, chest, dentition, shoulder, chest, elbow, knee and nuclear medicine where intend <=0.5mSv

• x 1.5 – Interventional radiology, use of contrast, CT, nuclear medicine where intend >5mSv

• x10 – other imaging.

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Patient Doses Much Greater Than Intended

[HSE PM77 (3rd)]

• x 1.1 – whole course of radiotherapy

• x 1.2 – single fraction of radiotherapy, or unsealed radionuclide therapy.

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Incidents•Any untoward occurrence which may result in excess radiation to staff or patients must be referred to the Radiation Protection Supervisor and the Radiation Protection Adviser, who will estimate the dose and liase with management, HSE, DoH, HCC, EA, etc. as appropriate

•Suspect equipment must be withdrawn from service and labelled according.

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Investigation

establishing what happened

identifying the failure

deciding on remedial action to minimise the chance of a similar failure

estimating the doses involved

decide whether patient informed (usually yes).

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Comforters and Carers

"individuals who (other than as part of their profession) knowingly and willingly incur an exposure to ionising radiation in the support or comfort of another person who is undergoing, or has undergone a medical exposure"

Dose constraint required.

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Comforters and Carers

• e.g. parent holding a child being X-rayed

• not a nurse, care assistant, etc.

• if < 1 mSv public dose limit, not “C&C”

• 5 mSv dose constraint

• if pregnant 1 mSv dose constraint

• must be aware of the risk.

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Reference Book List

• Making the best use of a Department of Clinical Radiology, RCR

• Advice on Exposure to Ionising Radiation during Pregnancy

• Guidance Notes

• IPEM 91