The law at work

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Chapter 2 The law at work

Simon Messer

KEY POINTS

The majority of the law involved with the workplace is related to health and safety.

There are a number of acts of parliament and regulations that form the principal legislation of which you must be aware when working in a hospital.

Underpinning British health and safety law is the Health and Safety at Work etc. Act 1974, which sets out general duties for both the employer and the employee.

The Ionising Radiation Regulations 1999 and Ionising Radiation (Medical Exposure) Regulations 2000 are of particular interest.

INTRODUCTION

Whilst working in the hospital environment there are a number of key documents detailing regulations and acts of parliament that ensure the safety of the employee and the public as well as ensuring the safe function of the hospital for the employer.

The full text of each act or regulation is available on the Internet and the links are provided at the end of this chapter. You are strongly advised to read the actual regulations, using the sections below as guidance. This applies especially to those relating to ionising radiation.

THE HEALTH AND SAFETY AT WORK ETC. ACT 1974

The Health and Safety at Work etc. Act 1974 (HSWA) is the most important British health and safety law and is applicable to nearly every work activity. It is a huge document and its objective is to provide protection for people at work and for the general public. It does this by setting out general duties for both the employer and the employee. Failure to comply with these duties constitutes a criminal offence and both employers and employees can be prosecuted. It also provides the basis under which other health and safety regulations are enabled, the following of which are particularly relevant to radiographic work:

• Management of Health and Safety at Work Regulations 1999

• Ionising Radiations Regulations 1999 (IRR99) and the Ionising Radiations (Medical Exposure) Regulations 2000 [IR(ME)R], both of which are fundamental to radiographic practice.

• Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 1995

• Manual Handling Operations Regulations 1992

• Personal Protective Equipment at Work Regulations 1992

• Control of Substances Hazardous to Health Regulations (COSHH)

GENERAL DUTIES OF EMPLOYERS

Section 2(1) of the Act places a general duty on the employer:

To ensure so far as is reasonably practicable, the health, safety and welfare at work of all his employees ¹

To achieve this, the employer is required to:

• provide and maintain safe equipment and safe methods of working (systems of work)

• provide safe arrangements for the storage, movement and use of materials

• give employees adequate instruction, training, supervision and information

• provide and maintain a safe workplace, including safe entrances and exits

• provide and maintain a safe working environment and adequate welfare facilities.

Employers are also required to ensure that people not in their employment, but who may be affected by their business activities, are not exposed to risks to their health and safety. This is particularly relevant to the hospital setting where public access is high.

GENERAL DUTIES OF EMPLOYEES

Employees have a number of duties and responsibilities. These include:

• to take reasonable care to ensure the health and safety of yourself and others, including the patient and members of the public

• to adhere to the systems of work specific to the department you are working in and report any hazards

• to cooperate with the employer, or anyone else, in complying health and safety legislation.

Sections 7 and 8 of the Act should be key to daily working practices. Section 7 of the Act states:

It shall be the duty of every employee while at work to take reasonable care for the health and safety of himself and of other persons who may be affected by his acts or omissions at work.¹

Section 8 of the Act states:

No person shall intentionally or recklessly interfere with or misuse anything provided in the interests of health, safety or welfare in pursuance of any of the relevant statutory provisions.¹

Failure to comply with either section 7 or section 8 may result in a summary conviction and a fine not exceeding £5000!

NO COST TO EMPLOYEES

Provision is made under the Act whereby ‘no employer shall charge any employee in respect of anything done or provided in pursuance of any specific requirement of the relevant statutory provisions’.¹

THE MANAGEMENT OF HEALTH AND SAFETY AT WORK REGULATIONS 1999

Whilst these regulations are not directly applicable to you as an employee, they are fundamental to all health and safety law and deal with an aspect which you will certainly be involved with; namely, risk assessment.

Under section 3 of these regulations, the employer is required to undertake ‘suitable and sufficient assessment of the risks to health and safety’ to which their employees are exposed while they are at work.²

Where a risk has been identified, the employer must then implement preventative or protective measures to avoid or minimise that risk. This is usually in the form of a thorough risk assessment.

THE IONISING RADIATIONS REGULATIONS 1999 (IRR99)

These regulations deal with the health and safety of those working with ionising radiation and are policed by the Health and Safety Executive (HSE). It is essential, as a radiation worker, that you are completely familiar with these regulations and you should therefore read them in their published form.

PART 1 INTERPRETATION AND GENERAL

The first section provides, amongst other things, definitions of terms such as ‘dose rate’.

PART II GENERAL PRINCIPLES AND PROCEDURES

This is an important section and deals with the need for risk assessment, the principle of restricting exposure to employees and the provision of personal protective equipment. It also covers the maintenance and examination of engineering controls, dose limitation and the need for contingency plans in the event of a reasonably foreseeable radiation accident.

PART III ARRANGEMENTS FOR THE MANAGEMENT OF RADIATION PROTECTION

This section deals with:

• the appointment and role of the Radiation Protection Advisor (RPA), whose main responsibility is to advise the employer and ensure these regulations are complied with

• the provision of information, instruction and training to employees working with ionising radiation

• the need for cooperation between employers.

PART IV DESIGNATED AREAS

The requirements for the designation and monitoring of controlled or supervised areas are detailed here, together with the need for Local Rules and the appointment of a Radiation Protection Supervisor (RPS). The RPS’s job is to ensure compliance with these regulations with respect to any work carried out in areas identified in the Local Rules. The RPS also has a role under the Ionising Radiations (Medical Exposure) Regulations 2000 as detailed below.

PART V CLASSIFICATION AND MONITORING OF PERSONS

This section deals with classified workers who are defined as any employee who is ‘likely to receive an effective dose in excess of 6 mSv per year or an equivalent dose which exceeds three-tenths of any relevant dose limit’.³ It also covers dose assessment and recording, medical surveillance and requirements in the event of an overexposure.

PART VI ARRANGEMENTS FOR THE CONTROL OF RADIOACTIVE SUBSTANCES, ARTICLES AND EQUIPMENT

This section deals with radioactive materials, their storage and transport and the need for accurate record keeping. There is also a requirement to notify the HSE in the event of certain occurrences including the spillage of a radioactive substance, which would give rise to a ‘significant contamination’.³ It also deals with installation, maintenance and quality assurance of equipment used for medical imaging.

PART VII DUTIES OF EMPLOYEES AND MISCELLANEOUS

The important part of this final section details the duties of the employee (you). In summary, these duties include:

• not to expose oneself or any one else to more ionising radiation than is reasonably necessary for the purposes of work

• to use personal protective equipment (PPE), such as lead rubber aprons, where provided

• to report equipment defects

• to look after PPE

• to comply with the employer’s dose monitoring and any request regarding medical surveillance.

THE IONISING RADIATIONS (MEDICAL EXPOSURE) REGULATIONS 2000 [IR(ME)R]

These regulations deal with the safe and effective use of ionising radiation used in clinical practice and they underpin all medical exposures.⁴ They are policed by the Department of Health. It is essential that you are completely familiar with these regulations.

The regulations impose duties on those responsible for administrating ionising radiation to protect people undergoing medical exposure. This would include:

• medical diagnosis

• treatment

• occupational health surveillance

• health screening

• medical research

• medicolegal procedures.

IR(ME)R DUTY HOLDERS

There are four identified duty holders, whose responsibility it is to enforce these regulations:

• Employer (‘Legal person’)

• Referrer

• Practitioner

• Operator.

ADMINISTRATIVE AND PROCEDURAL ASPECTS OF PATIENT PROTECTION

Justification

Before an exposure can take place, an IR(ME)R practitioner must justify it. For an exposure to be justified, the benefit to the patient from the diagnostic information obtained should outweigh the detriment of the exposure. The exposure would normally be expected to provide new information to aid the patient’s management or prognosis. Under no circumstances can the routine radiography of ‘new’ patients prior to clinical examination be justified (Box 2.1).

Box 2.1 Considerations required to justify an exposure for a diagnostic examination

• The availability and findings of previous radiographs.

• The specific objectives of the exposure in relation to the history and examination of the patient.

• The total potential diagnostic benefit to the individual.

• The radiation risk associated with the radiographic examination.

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

Optimisation

For every X-ray exposure, the operator must ensure that doses arising from the exposure are kept ‘as low as reasonably practicable’ (ALARP) and consistent with the intended diagnostic purpose. This process is known as ‘optimisation’ and relies heavily upon the professional competence and skill of the operator. So, while the operating procedures and protocols provide a framework, the operators should still use their skill and knowledge in deciding how best to perform individual exposures.

Where a standard protocol is followed, exposure factors do not need to be recorded. However, for non-standard exposures, the factors relevant to the patient dose should be recorded so that, if necessary, an estimation of the dose to the patient can be made at a later date (e.g. following an enquiry or complaint from a patient).

Clinical evaluation

The written procedures must ensure that a clinical evaluation of each X-ray is carried out and recorded. If it is known prior to exposure that no clinical evaluation will occur then the exposure is not justified and must not take place. Clinical evaluation does not necessarily entail a full radiology report but should show that each radiograph has been evaluated and also provide enough information so that it can be subject to a later audit.

Medicolegal and other third-party exposures

These are usually conducted for financial reasons rather than medical benefit. Consequently, the need for and usefulness of such examinations should be critically examined when assessing whether they are justified. The regulations recommend that the patient’s written consent be obtained prior to such examinations taking place. Only a medical/dental practitioner can request such exposures.

Female patients of childbearing age

Regulation 6(1)(e) of IR(ME)R2000 prohibits the carrying out of a medical exposure of a female of child-bearing age without an enquiry as to whether she is pregnant. This is only relevant if the primary X-ray beam is likely to irradiate the pelvic area. If this is the case, the recommended course of action is as follows:

• The operator asks the patient whether she is, or might be, pregnant and records the response.

• If there is no possibility of pregnancy, the radiographic examination can proceed.

• If the patient is definitely, or probably, pregnant, the request should be referred back to the IR(ME)R practitioner to review the justification and decide whether to defer the investigation until after delivery.

• If the examination is undertaken, the fetal dose must be kept to a minimum consistent with the diagnostic purpose.

• Use a lead rubber apron.

• If the patient cannot exclude the possibility of pregnancy, she needs to be asked whether her menstrual period is overdue.

• If pregnancy cannot be excluded but her menstrual period is not overdue, the examination can proceed.

• If the period is overdue you should proceed as if the patient were pregnant.

‘Excessive’ exposure of patients

It is always possible that an incident may arise where a patient receives an exposure that is much greater than intended, either through equipment malfunction or operator error. If this happens, the regulations require the employer to make a preliminary investigation to confirm the incident and then notify the appropriate authority:

• HSE (equipment malfunction)

• IR(ME)R Inspectorate (clinical/operator error).

A detailed investigation must then be carried out to establish what happened and why, what doses were involved and what needs to be done to minimise the risk of a similar event in the future. The employer must retain the report of this investigation for at least 50 years! The Regulations require that exposed patients should be informed of the incident unless not doing so can be justified. It is a local decision on how, when and by whom the patient is notified, but the IR(ME)R practitioner and referring clinician should be involved.

It should be noted that patients who undergo a procedure that was not intended (as a result of mistaken identification for example), and thus exposed to a radiation dose, should be considered as having received an unintended dose. An investigation and notification to the IR(ME)R Inspectorate is required. It is therefore very important as an operator to ensure that you have the correct patient for the correct examination!

Radiation protection supervisor (RPS)

The RPS is appointed by the employer to help ensure compliance with IRR99, and in particular to supervise arrangements of Local Rules. Such a person must have received appropriate training and should be closely involved with radiography.

Radiation protection adviser (RPA)

The employer must appoint an RPA in writing. Their role is to give advice on any aspect of radiography, including:

• controls, design features, safety features and warning devices

• monitoring equipment

• risk assessment

• staff training

• the assessment and recording of radiation doses received by staff.

Medical physics expert (MPE)

An ‘MPE’ is:

a person who holds a science degree or its equivalent and who is experienced in the application of physics to the diagnostic and therapeutic uses of ionising radiation ⁴

The role of the MPE is to give advice on such matters as the measurement and optimisation of patient dose. An RPA would be expected to be able either to act as the MPE or to suggest an appropriate person.

Diagnostic reference levels (DRLs)

The employer must consult with the MPE and adopt DRLs for local use, having regard to national/European DRLs where available. DRLs are defined in IR(ME)R as:

dose levels in radiodiagnostic practices for typical examinations for groups of standard-sized patients or standard phantoms for broadly defined types of equipment ⁴

They are not normally expected to be exceeded without good reason. Where radiography is being carried out using doses consistently above the DRLs a thorough review of radiographic practice must be made by the employer, either to improve the current techniques or to justify their continued use.

Training

Staff engaged in any aspect of radiography must have received appropriate and adequate training commensurate with their duties so that they know:

• the risks to health created by exposure to X-rays

• the precautions that need to be taken

• the importance of complying with the medical, technical and administrative requirements of legislation.

Regulation 4(4) of IR(ME)R 2000 places a responsibility on the employer to ensure that every IR(ME)R practitioner and operator has received adequate and appropriate training and undertakes continuing education/training after qualification. An up-to-date record of training must be maintained and be available for inspection. It is also a requirement that other persons who are directly concerned with the radiography (a parent supporting a child for example) are given adequate information to ensure their health and safety.

Finally, female employees engaged in radiography must be informed of the possible risk to a fetus and of the importance of informing their employer, in writing, if they become aware that they are pregnant.

THE DATA PROTECTION ACT 1998

The Data Protection Act 1998 came into force on the 1st March 2000, replacing the previous 1984 Data Protection Act, and provides a set of rules for processing personal information (data).

The Act relates to ‘personal data’, which is defined as relating to a living person who can be identified from that data. This can take the form of automated/electronic records as well as manual/paper records held in a relevant filing system, including health records, and includes any expression of opinion about the individual.

The Act gives rights to individuals, defined as ‘data subjects’, about whom personal data is held and also places duties on ‘data controllers’ who record and use that information.

Obviously, within a healthcare setting, there is a vast amount of information held relating to patients, most of which (if not all) falls within the scope of the Act. It is essential, therefore, that you are aware of both your obligations under the Act and the patient’s rights.

GENERAL PRINCIPLES

Schedule 1 details eight data protection principles, which need to be complied with. In summary, it states that all personal data shall be:

• fairly and lawfully processed (this includes the common law requirement of confidentiality)

• processed for specified and lawful purposes and not further processed in any manner incompatible with those purposes

• adequate, relevant and not excessive in relation to the purpose

• accurate and kept up to date

• not kept for longer than is necessary for the purpose

• processed in accordance with the data subject’s rights under this Act

• secure against unlawful processing, accidental loss, destruction or damage

• not transferred to countries outside the European Economic Area without adequate protection.

Schedule 2 applies to all personal data and the first requirement is that the data subject has given their consent for processing. It also details a number of conditions, at least one of which must be met, under which the processing of the data can be classified as ‘necessary’. The processing of ‘sensitive personal data’, which includes information about the individual’s racial or ethnic origin, politics, religion, health, or sexual life, is dealt with in Schedule 3. Not only do the requirements of Schedule 2 have to be met for this type of data, but also more stringent conditions, one of which is that the data be used for ‘medical purposes’.

RIGHTS OF DATA SUBJECTS

Individuals, or data subjects, have a number of rights, as detailed in Part 2 of the Act, which include:

• the right to be informed who their data controller is (NHS Trust for example) and for what purposes their data will be processed

• the right to prevent processing for the purposes of direct marketing or if the processing will cause them undue distress (there are, as ever, exceptions to this)

• the right to access their own personal data. This is one of the central aims of the Act and is achieved by applying to the data controller in writing and including a stipulated fee.

UNLAWFUL OBTAINING OF PERSONAL DATA

Section 55 of the Act makes it an offence to person to obtain or disclose personal data without the consent of the data controller. Anyone who suffers damage due to unauthorised disclosure of his or her personal information is eligible for compensation.

PATIENT CONFIDENTIALITY

The NHS has a confidentiality code of practice regarding patient data, which is underpinned by the Data Protection Act 1998 and ethical obligations of confidentiality.⁶ Healthcare workers must be familiar with this essential document.

THE REPORTING OF INJURIES, DISEASES AND DANGEROUS OCCURRENCES REGULATIONS 1995 (RIDDOR)

Reporting accidents and ill health at work is a legal requirement. The information enables the authorities to identify where and how risks arise and to investigate serious accidents. The authorities can then advise on preventive action to reduce injury, ill health and accidental loss.

These regulations require the employer to notify the enforcing authority of any accident that results in or which could have resulted in death, injury or disease.

The regulations specify:

• the types of injury that must be reported immediately (e.g. death of an employee at work)

• the types of injury that must be reported within 10 days (e.g. accidents at work resulting in an employee being unable to work for more than three consecutive days – an ‘over-3-day’ injury)

• the types of occupational related diseases which must be reported

• incidents and conditions relating to flammable gases and LPG (propane and butane) which must be reported within 14 days

• types of incident with the potential for causing injury (Dangerous Occurrences) which must be reported immediately

• the requirements for keeping specific records.

THE MANUAL HANDLING OPERATIONS REGULATIONS 1992

Manual handling is defined as:

‘An activity which involves lifting, lowering, carrying, pushing, pulling or supporting by hand or by bodily force’ ⁷

Manual handling is something that we all do every day. As a healthcare professional moving patients and equipment, you are even more susceptible to injury. In the year 2003/04, 10 040 ‘over-3-day’ injuries to employees in the health services sector were reported under RIDDOR. Of these, 53% (5361) were a result of manual handling accidents.⁸ It is essential, therefore, that you are aware of these regulations.

As far as health and safety legislation goes, these regulations are very simple and the substance is contained in one regulation:

• To avoid any manual handling operation which has risk of injury to the person performing the task.

Where this cannot be done, the employer has to undertake a risk assessment of all such operations and take appropriate steps to remove or reduce the risk of injury. The employer must then provide the employee with information about the task and appropriate training in handling techniques.

You, as an employee, have a legal duty to make full and proper use of any equipment or system of work the employer provides for manual handling and to inform your employer of any physical condition you might have that could affect your ability to do this (if you were pregnant, for example).

THE PERSONAL PROTECTIVE EQUIPMENT AT WORK REGULATIONS 1992

Personal protective equipment (PPE) relates to equipment designed to be worn or held by workers to protect them against one or more identified hazards. PPE should only be used when risks cannot be avoided or adequately reduced by technical means or safe systems of work.

The employer must:

• conduct a risk assessment

• select appropriate and suitable PPE that fits the worker

• provide both the PPE (free of charge) and a suitable place in which to keep it

• ensure the PPE is maintained in clean and good working order

• provide training for workers on its use and care.

As an employee, you must:

• ensure that all PPE provided is properly used in accordance with any training and instructions received in its use

• ensure that the PPE is returned to its correct place of storage after use

• report to the employer any loss of, or obvious defect in, that PPE.

THE CONTROL OF SUBSTANCES HAZARDOUS TO HEALTH REGULATIONS (COSHH)

The aim of these regulations is to prevent any disease arising from the use of chemicals and other hazardous materials in the workplace. These include substances used in work, such as adhesives and solvents, substances created by work activity (e.g. dust and fumes), naturally occurring substances and biological agents.⁹ You might question the relevance to radiographic practice until you consider that even in today’s environment of computerised/digital radiography, there are still photographic chemicals used in some areas of the department and these are regulated by COSHH.

The regulations place a number of duties on the employer:

• Assess the risk involved, including the route of entry into the body. No work may be carried out with that substance until the assessment has been completed.

• Decide what precautions are needed to prevent or control the exposure. (As ever with health and safety, the emphasis should be on prevention rather than control.)

• Ensure that the control measures are used and properly maintained.

• Monitor the exposure in the environment.

• Conduct health surveillance of employees where necessary.

• Provide employees with adequate information and training.

• Ensure there are adequate measures in place in case of an ‘accident, incident or emergency’.

As the employee, you have a duty under section 8 to make full and proper use of any control measure or system of work provided by the employer. Additionally, you have a responsibility to ensure anything you use under COSHH is returned afterwards to its proper place and, if defective, to report it to your employer.¹⁰

References

1 The Health and Safety at Work etc. Act 1974. London: HMSO.

2 Health and Safety Commission. In Management of health and safety at work: approved code of practice. London: HMSO; 2000.

3 The Ionising Radiations Regulations 1999. (SI 1999/3232). London: HMSO.

4 The Ionising Radiation (Medical Exposure) Regulations 2000 (SI 2000/1059). London: HMSO.

5 The Ionising Radiation (Medical Exposure) (Amendment) Regulations 2006 (SI 2006/2523). London: HMSO.

6 Department of Health. In Confidentiality: NHS code of practice. London: DoH Publications; 2003.

7 Health and Safety Executive. In Manual handling: Manual Handling Operations Regulations, 1992 – guidance on regulations. London: HMSO; 1992.

8 . Health and Safety Executive. Injuries and ill health in health services. 2005. Online. Available http://www.hse.gov.uk/statistics/industry/healthservices.htm

9 Health and Safety Executive. COSHH: A brief guide to the Regulations. In What you need to know about the Control of Substances Hazardous to Health Regulations 2002 (COSHH). Sudbury, UK: HSE Books; 2004/5.

10 The Control of Substances Hazardous to Health Regulations 2002 (SI 2002/2677). London: HMSO.

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