Regulations

Published on 12/06/2015 by admin

Filed under Radiology

Last modified 22/04/2025

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19 Regulations

General legislation

  The following are some of the regulations that apply to the UK, and other readers should check the local regulations for their own country. Only an outline of the main contents have been given, as the main texts are readily available on the internet
Human Rights Act 1988 Areas of note
• Article 2 Right to life
• Article 5 Right to liberty and security
• Article 8 Right to respect for private and family life
• Article 9 Freedom of thought, conscience and religion
• Article 10 Freedom of expression
• Article 14 Prohibition of discrimination
Data Protection Act 1998 Eight basic principles:
Personal information must be:
1. Processed fairly and legally
2. Obtained for limited purposes only
3. Adequate, relevant and not excessive
4. Accurate
5. Not kept longer than is necessary
6. Processed according to an individual’s rights in the Act
7. Kept secure
8. Not transferred abroad without adequate protection
Freedom of Information Act 2000 Gives the power to individuals to:
• Ask a public organisation for information on specific subjects
Covers all NHS organisations who have to:
• Have a publication scheme for releasing information
• Tell applicants whether or not they hold information not covered under the publication scheme
• Disclose information to applicants, providing it is not exempt under the Act
Health and Safety at Work Act 1974 The Act outlines the general duties that:
• Employers have towards employees and members of the public
• Employees have to themselves and to other employees
The Management of Health and Safety at Work Regulations 1999 Requires employers to:
• Carry out a risk assessment
• Make arrangements for implementing the measures identified by the risk assessment
• Appoint competent people to help to implement the arrangements
• Set up emergency procedures
• Provide information and training
• Work with other employers sharing the same workplace
Health and Safety (Display Screen Equipment) Regulations 1992 These regulations cover employees who use display screen equipment daily and for continuous spells of 1 hour or more at a time
The key duties of employers are:
• To identify areas where display screen equipment is used
• To identify which staff use the equipment and for how long
• To assess the risks to users (if any) and reduce the risks where appropriate
• To ensure that any new work stations meet the health and safety requirements
• To make sure that staff have adequate breaks and changes of activity
• To provide users with eye and eyesight tests, if appropriate
• To ensure that any users receive adequate training and information concerning safe working practices
• The Medicines (Administration of Radioactive Substances) Regulations 1978
• The Radioactive Substances Act 1993
• The Ionising Radiations Regulations 1999
• The Radioactive Material (Road Transport) (Great Britain) Regulations 2002
• The Ionising Radiation (Medical Exposure) Regulations 2000
• Notes for the Guidance on the Clinical Administration of Radiopharmaceuticals and Use of Sealed Radioactive Sources 2006

The following are concerned with radiation

The Medicines (Administration of Radioactive Substances) Regulations 1978
The Medicines (Administration of Radioactive Substances) Amendment Regulations 1995		 Main areas
• Prior authorisation to provide protection for the patients during the clinical use of radioactive substances
• Prior authorisation to provide protection for the volunteers during research in the use of radioactive substances
• Indirectly, the protection of staff when using radioactive substances
• Criteria for the issue and renewal of a certificate to administer radioactive substances
• Only a doctor or dentist holding a certificate issued by the Health Minister or people working under the direction of the doctor or dentist can administer radioactive substances
• The amendment regulations make some administrative changes to the regulations
The Radioactive Substances Act 1993 Covers
• Registration of use of radioactive material and mobile radioactive apparatus
• Disposal of radioactive waste
• Duty to display documents
The Ionising Radiations Regulations 1999 Main areas
General principles and procedures
• Authorisation of specific practices
• Notification of specified work
• Prior risk assessments
• Restriction of exposure
• Personal protective equipment
• Maintenance and examination of engineering controls and personal protective equipment
• Dose limitation
• Contingency plans
Arrangements for the management of radiation protection
• Radiation protection adviser
• Information, instruction and training
• Cooperation between employers
Designated areas
• Designation of controlled or supervised areas
• Local rules and radiation protection supervisors
• Monitoring of designated areas
Classification and monitoring of persons
• Designation of classified persons
• Dose assessment and recording
• Estimated doses and special entries
• Dosimetry for accidents, etc.
• Medical surveillance
• Investigation and notification of overexposure
• Dose limitation for overexposed employees
Arrangements for the control of radioactive substances, articles and equipment
• Sealed sources and articles containing or embodying radioactive substances
• Accounting for radioactive substances
• Keeping and moving radioactive substances
• Notification of certain occurrences
• Duties of manufacturers, etc. of articles for use in work with ionising radiation
• Equipment used for medical exposure
• Misuse of or interference with sources of ionising radiation
Duties of employees
• Approval of dosimetry services
• Defence on contravention
• Exemption certificates
• Extension outside Great Britain
• Modifications relating to the Ministry of Defence
The Radioactive Material (Road Transport) Regulations 2002 Main areas
• Transport of radioactive material
• Radiation protection, safety programmes and information to the public
• Activity limits and material restrictions
• Transport controls
• Further responsibilities of consignors and carriers
• Requirements for radioactive materials, packaging and packages
• Test procedures
• Approval requirements for designs and shipments
• Approval certificates
• Radiological emergencies and intervention arrangements
The Ionising Radiation (Medical Exposure) Regulations 2000
Amended 2006		 Concerned with
• Storage and disposal of radioactive waste
Notes for the Guidance on the Clinical Administration of Radiopharmaceuticals and Use of Sealed Radioactive Sources 2006 Main areas
• Criteria for obtaining certificates to administer radiopharmaceuticals and sealed radioactive sources
• Diagnosis
• Treatments
• Research requirements
• Investigations in children and young persons
• Conception, pregnancy and breast feeding
• Thyroid blocking
The Appendices cover:
• Routine procedures, activities and doses
• Calculating radiation doses
• Sample size and power calculations
• Training and experience
• Additional Acts and Regulations
• Certification process under the MARS Regulations 1978
• Communicating risk to Local Research Approved Bodies and research subjects

Legislative requirements for dealing with the use and disposal of photographic chemicals are dealt with under the following acts

 
• Control of Substances Hazardous to Health (COSHH) Regulations 1999
• The Personal Protective Equipment (EC Directive) Regulations 1992
• Environmental Protection Act (EPA) 1990
• Water Act 1989
• The Chemicals (Hazard Information and Packaging for Supply) Regulations 1994 (amended 1999)
• Pollution Prevention and Control Act 1999
• European Packaging Waste Directive 1994
COSHH Regulations Regulation 3
• The employer is responsible (so far as it is reasonably practicable) for all people who may be affected by substances whether or not they are directly employed
Regulation 6
Assessment of health risks created by work involving substances hazardous to health
• An assessment of the risks of any substance hazardous to health should be carried out before the employee is asked to work with the substance
• The employee can review an assessment if it is thought to be no longer valid
Regulation 7
Prevention or control of exposure to substances hazardous to health
• The emphasis is placed on preventing injury happening
• Personal protective equipment must be provided
• With regard to inhalation of chemicals the occupational exposure standards (OESs) must not be exceeded
• Lists of OESs are published by the Health and Safety Executive in leaflet EH40 which is updated annually
• Two exposure limits are given for each chemical: the long term (8 hours weighted average) and the short term (10 minutes weighted average)
• OESs are basically the vapour pressures over a given time and are measured in parts per million
• Regulation 7.5.b. requires the employer to take action and, as soon as is reasonable, remedy the situation if it is identified that the OES has been exceeded
To reduce the quantity of fumes
• Ensure there is adequate ventilation (in the order of 12–15 air changes per hour)
• Duct processors to the outside air
• Use of low temperature and ‘low fume’ chemicals
• Good drainage
• The proper positioning of silver recovery equipment
• The safe and correct handling of chemicals
Regulation 8
Use of control measures
• Employers should ensure that substances are used in the correct manner
• Employees should ensure that they use the equipment correctly
• Report any defects to their employer as soon as possible
Regulation 9
Maintenance, examination and test of control measures
• Non-disposable, personal protective equipment should be checked at ‘suitable intervals’ by examination and, where necessary, tests
• A record should be made of the date, the examination/test, the results and, if appropriate, any repairs undertaken
• The records should be kept for 5 years from the date they were made
Regulation 10
Monitoring exposure at the workplace
• Ensuring that the occupational exposure limits were not breached for those substances present in processing chemicals
Regulation 11
Health surveillance
• Although modern chemicals have a reduced risk staff should still be monitored
Regulation 12
Information, instruction and training
The employer must provide:
• Instruction and training in the safe use of processing chemicals
• Including information about the health hazards
• The precautions which should be taken
• If an OES is exceeded, the employee (or their representative) should be informed
The Personal Protective Equipment (EC Directive) Regulations 1992 Personal protective equipment is provided which is of an approved standard
• For the:

image Manual mixing of chemicals
image Wiping up of chemical spillages
image Changing of processing chemicals
image Cleaning of machines

• Would include:

image Protective clothing
image Gloves
image Eye protectors
image The use of automatic chemical mixers should be considered
Environmental Protection Act (1990) ‘Integrated Pollution Control’
• Covers the discharge of certain substances to land, water or air
• This area does not appear to have implications for imaging departments
‘Duty of Care’
• The person disposing of waste should only transfer it to those who are authorised to receive it
• Checks should be made that anyone receiving departmental waste, e.g. silver recovery firms, is licensed to dispose of the product
Water Act (1989)
• A trade effluent discharge consent is required
• The amount charged is decided by the strength and volume of the effluent
• Many economies (and some Water Authorities) set the silver level at 2 parts per million
• The 23 most dangerous chemical pollutants are on what is referred to as the ‘red list’
• Silver appears on the next list (grey)
The Chemicals (Hazard Information and Packaging for Supply) Regulations 1994 (amended 1999) (CHIP) These regulations cover such topics as:
• The classification of dangerous substances
• The symbols used for dangerous substances
• The preparation of dangerous substances
• Information for safety data sheets
• The labelling of substances
• The British and International Standards for child resistant fastenings and tactile warning devices
The regulations are for manufacturers and suppliers
• Hazard being defined as: ‘the inherent properties of a chemical’
• Risk: ‘the probability of the hazardous properties of the chemical causing harm to people or the environment’
The label provides information about the hazards and therefore the precautions which can be taken. These include:
• Storage
• Clothing to be worn during preparation
• Correct handling
• Disposal of material
Pollution Prevention and Control Act 1999 Implementing the European Council Pollution Prevention Directive (96/61/EC) Follows the principle that the polluter pays and encourages the prevention of pollution. It is concerned with pollution into the air, water and the soil and covers both old and new buildings. Its aim is to integrate all existing legislation
Annex IV mentions:
• The use of low-waste technology
• The use of less hazardous substances
• Recovery and recycling
• The nature, effect and volume of emissions
• The reduction of the impact of emissions on the environment
European Packaging and Packaging Waste Directive 1994 (94/62/EC)
• Sets targets for the reuse and recycling of plastics, paper, cardboard, metal and glass
• The target for packaging is that between 50 and 65% of waste should be recovered and up to 70% of commercial waste

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