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Y2 Nuclear Medicine - MPY8009 > Ionising radiation protection legal and regulatory basis > Flashcards

Ionising radiation protection legal and regulatory basis Flashcards

1
Q

What is the definition of a sealed source?

A

A radioactive source whose structure is such as to prevent, under normal conditions of use, any dispersion of radioactive substances into the environment, but excludes RAS inside a nuclear reactor or any fuel element.

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2
Q

What is the definition of a High-activity Sealed Source (HASS)?

A

A sealed source for which the quantity of the radionuclide is equal to or exceeds the relevant quantity value set out in Part 4 of Schedule 7 of IRR17.

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3
Q

What is the definition of an open source?

A

Radioactive material which is not a sealed source and which is not waste.

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4
Q

What is the definition of radioactive waste and what are the differences between the IRR17 and EPR2016 defintions?

A

Essentially any open or sealed source which is no longer a source and for

IRR17: where activity cannot be disregarded for the purposes of radiation protection (column 2, Part 1 Table, Schedule 7)

EPR2016: meets the radioactivity concentration limits not to be exempt (column 2, Table 2, Part 3, Schedule 23) as amended in 2018

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5
Q

Is a 99Mo/99mTc generator an Open or Sealed source?

A

It is an open source as nothing is truly encapsulated.

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6
Q

Under which legislation are the Environmental Permitting Regulations 2016 made?

A

Pollution Prevention and Control Act 1999

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7
Q

Who enforces the Environmental Permitting Regulations 2016?

A

The Environment Agency through PIR/RSR Inspectors

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8
Q

What key areas are regulated for radioactive material under EPR 2016?

A
  • Quantity of material held
  • Purpose of use
  • Storage and security
  • Records and procedures
  • Staff training
  • Disposal of radioactive waste
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9
Q

When is a source no longer a source (i.e. part of permitted holding)?

A
  • Following patient administration
  • Any source moved to accumulating waste
  • Liquid sources being discharged as waste to drains
  • Open sources transferred ro another permitted holder
  • Sealed sourced disposal or transfer
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10
Q

What would you expect the conditions for the keeping and use of a permit to include?

A
  • Change of Name or registered office address or cessation of keeping or use of sources
  • Management system
  • Sources may be kept only for the permitted use(s)
  • Total activity on the premises must not exceed the permitted holding for each specific radionuclide or group
  • Prevent:
    – Loss or escape of any source
    – Unauthorised access to sources
    – Premises access other than to authorised users
  • Escape of sources
  • Records
  • Offences
  • Penalties
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11
Q

What is teh definition of orphn sources?

A

An open or sealed radioactive source which is neither exempted nor under regulatory control, e.g. because it has never been under regulatory control or because it has been abandoned, lost, misplaced, stolen or otherwise transferred without proper authorisation)

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12
Q

Whatare the additional permit conditions for HASS sources?

A
  • Security in accordance with the NaCTSO RESTRICTED document “Security Requirements for Radioactive
    Sources”
  • Security culture, awareness of the threat and need to Deter, Detect, Delay, Respond
    – Site security plan
    – Extendibility of security measures dependent upon the terrorist threat level
    – Information security plan
    – Specified number of physical security measures (delay source access)
    – Timely detection of unauthorised access by monitored intruder alarm
    – Timely police response to alarm
    – Photographs of sources
    – Interim reports to EA
    – Evidence of financial provision for disposal costs
    – Stringent personnel checks Re: security
    – Written source specific emergency procedures (fire, loss, theft or unauthorised use)
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13
Q

Who is the Licensing Authority under the Ionising Radiation (Medical Exposure) Regulations 2017?

A

The Secretary of State, advised by ARSAC (Administration of Radioactive Substances Advisory Committee)

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14
Q

What are the two types of licences under the Ionising Radiation (Medical Exposure) Regulations 2017 and the key differences?

A
  • Practitioner licence
  • NOT site specific
  • Free
  • Employer licence
  • One per site
  • Fees apply
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15
Q

What aspects do the licences under IR(ME)R 2017 govern?

A

Licences govern:

  • To whom,
  • By whom,
  • What,
  • How,
  • Why, and
  • How much radioactive medicinal product is administered
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16
Q

What information is included in the licenses?

A

Information relating to:
* organisational arrangements for protection & safety;
* staff competence;
* design features of the installation;
* anticipated occupational & public exposures;
* safety assessment of the activities
* emergency procedures;
* maintenance, testing, inspection & servicing
* management of waste
* quality assurance

17
Q

What does ARSAC stand for

A

ARSAC stands for Administration of Radioactive Substances Advisory Committee

18
Q

What are the eligibility requirements for an ARSAC practitioner licence?

A

Applicants must:

  • Be medically qualified (Diagnostic, Therapeutic, or Research),
  • Have theoretical and practical training (as per IRMER17 Schedule 3).
19
Q

What must an employer have to obtain an ARSAC employer licence?

A

Employers must have:

  • Suitable equipment, facilities, and support staff.
  • Normally:
  • MPE (Medical Physics Expert),
  • A healthcare professional with responsibility for quality of RMPs or sealed RA source storage,
  • Scientific support to maintain equipment and facilities,
  • Medical Director or Chief Executive to sign
20
Q

What activities require notification under the graded approach?

A
  • Certain work with radioactive material (RAM)
  • Work in a Radon atmosphere where the annual average concentration exceeds 300 Bq.m⁻³
21
Q

What activities require registration?

A
  • Use of radiation generators (e.g., most X-ray work),
  • Some work with RAM (see Schedule 7 IRR17)
  • Transport of RAM
22
Q

What activities require consent to perform?

A

Separate consent is needed for each practice, such as:

  • RAM administration to people,
  • Radiopharmacy,
  • HASS (High-Activity Sealed Sources),
  • RAM waste management
23
Q

What must an employer submit to obtain consent for specific practices?

A

A Safety Assessment which is inspected by the HSE and either grants or refuses consent.

24
Q

What is the legislation for the transport of RAM?

A

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

25
Q

Who enforces the regulations for Class 7 goods (radioactive materials)?

A

The Office for Nuclear Regulation (ONR)

26
Q

What are the duty holders under CDG2009 and what is their role?

A

Consignor: consigns RAM for transport
(e.g. returning 99Mo/99mTc generators)
Carrier: transports RAM
Note: a legal entity consigning or carrying RAM MUST at least REGISTER with the HSE (the Authorising Authority) under IRR17, although the ONR is the
Enforcing Authority for all activities between packing & unpacking)
Consignee: receives RAM

27
Q

When does CDG09 NOT apply to radioactive materials?

A

If the activity concentration AND the activity limit are not exceeded, the material is EXEMPT.

28
Q

What are excepted packages?

A

Packages with activity or concentration levels above the exemption limits but below the excepted package limits. Limits depend on the physical form of the material.

29
Q

What are Type A packages?

A

Packages with activity levels above the excepted package limits but below the Type A limits.

30
Q

What is RADSAFE?

A

A private company offering
mutual assistance in the event of a transport accident involving
radioactive materials belonging to a RADSAFE member.

31
Q

Who are RADSAFE members?

A

British nuclear industry and others, e.g. GE
Healthcare, Eckert & Ziegler Environmental Services

32
Q

What is the reponsibility of RADSAFE?

A

To support the emergency services to
minimise risk to public

33
Q

What is the consignor responsibility?

A

The consignor has full responsibility for clean-up, other essential remediation work, consideration of financial liability etc

Y2 Nuclear Medicine - MPY8009 (11 decks)

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