Chapter 2 The law at work
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:
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 employees1
To achieve this, the employer is required to:
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:
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
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 respectof 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
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.
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:
IR(ME)R DUTY HOLDERS
There are four identified duty holders, whose responsibility it is to enforce these regulations:
The employer
The employer has to provide a written framework of procedures for medical exposures and ensure that they are complied with by the practitioner, operator and him/herself and must also ensure that written protocols are in place for every type of standard radiological practice for each piece of equipment.
The employer also has to establish:
The employer must ensure that every practitioner and operator is adequately trained and undertakes continuing education and training after qualification. This must include training related to the use of new clinical techniques and the relevant radiation protection requirements.
The referrer
The ‘referrer’ is defined as being:
a registered health care professional who is entitled in accordance with the employer’s proceduresto refer individuals for medical exposure to a practitioner; ‘registered health care professional’ means 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 2002.5
There is a legal requirement on the referrer to identify the patient fully and to supply sufficient clinical information for the request to be justified by the practitioner. A history and clinical examination of the patient is essential prior to any request for radiographs.
The practitioner
The ‘practitioner’ is defined as:
a health care professional who is entitled in accordance with the employer’s procedures to take responsibility for an individual medical exposure.5
Practitioners must comply with employer’s procedures. They are responsible for the justification and authorisation of individual exposures. The regulations require them to be adequately trained.
The operator
Any person who is entitled, in accordance with the employer’s procedures, to carry out all or part of the practical aspects associated with a radiographic examination.4
This is predominately the role that you will occupy. All operators must be adequately trained, not only to include professional qualifications but also in terms of suitable training on any new equipment or techniques.
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).
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’ andrelies 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:
‘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:
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 ofmistaken 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:
Medical physics expert (MPE)
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 radiation4
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 equipment4
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.
Quality assurance (QA)
Both IRR99 and IR(ME)R2000 place clear, but different, responsibilities on the employer to establish and maintain quality assurance programmes in respect of radiography. The purpose of such QA is to ensure consistently adequate diagnostic information, whilst radiation doses to patients and staff are controlled to be as low as reasonably practicable. All necessary procedures must be in writing and should:
The essential procedures within a programme suited to radiography will relate to:
Training
Staff engaged in any aspect of radiography must have received appropriate and adequate training commensurate with their duties so that they know:
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:
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:
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 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:
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 identifiedhazards. PPE should only be used when risks cannot be avoided or adequately reduced by technical means or safe systems of work.
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:
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
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.
The Ionising Radiations Regulations 1999 (SI 1999/3232). London: HMSO.
This document provides all of the regulations to ensure health and safety guidelines are followed and implemented when using ionising radiation..
The Ionising Radiation (Medical Exposure) Regulations 2000 (SI 2000/1059). London: HMSO.
This document provides the regulations, which ensure the safe and effective use of ionising radiation in clinical practice..
The Health and Safety at Work etc. Act 1974. http://www.healthandsafety.co.uk/haswa.htm
The Management of Health and Safety at Work Regulations 1999. http://www.opsi.gov.uk/si/si1999/19993242.htm
The Ionising Radiation Regulations 1999. http://www.opsi.gov.uk/si/si1999/19993232.htm
The Ionising Radiations (Medical Exposure) Regulations 2000 [IR(ME)R]. http://www.opsi.gov.uk/si/si2000/20001059.htm
The Ionising Radiation (Medical Exposure) (Amendment) Regulations 2006. http://www.opsi.gov.uk/si/si2006/20062523.htm
The Data Protection Act 1998. http://www.dh.gov.uk/PolicyAndGuidance/InformationPolicy/PatientConfidentialityAndCaldicottGuardians/fs/en
The Reporting of Injuries Diseases and Dangerous Occurrences Regulations 1995 (RIDDOR). http://www.opsi.gov.uk/si/si1995/Uksi_19953163_en_1.htm
The Manual Handling Operations Regulations 1992. http://www.opsi.gov.uk/si/si1992/Uksi_19922793_en_1.htm
The Control of Substances Hazardous to Health Regulations (COSHH). http://www.opsi.gov.uk/si/si2002/20022677.htm#3