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S. Christofides¹, R. Padovani², W. Van der Putten³, A. Torresin⁴, P. Allisy-Roberts⁵, C.J. Carvana⁶, P. Sharp⁷, K-U. Kash^8
1 Medical Physics Department, Nicosia General Hospital, Nicosia, Cyprus
² SO di Fisica Sanitaria, Ospedale S. Maria della Misericordia, Udine, Italy
³ Department of Medical Physics and Bioengineering, Galway University Hospitals, Galway, Ireland
⁴ Medical Physics Dept, Azienda Ospedale Niguarda, Milano, Italy
⁵ Ionizing Radiation Department, International Bureau of Weights and Measures (BIPM), Sèvres, France
⁶ Biomedical Physics, Imaging and Devices. Radiation Protection, Quality Control of Imaging Devices, Faculty of Health Sciences, University of Malta, Msida, Malta
⁷ Bio-Medical Physics & Bio-Engineering, University of Aberdeen & Grampian Hospitals NHS Trust, Aberdeen, UK
⁸ University of Applied Sciences (BHT), Berlin, Germany
 

Abstract

As low as reasonably achievable (ALARA) has long been associated with ionising radiation and ALARA is a key to ensuring the safe and appropriate use of medical radiation in healthcare. This article describes a Medical ALARA Culture as part of the wider safety culture in the healthcare environment. To illustrate this, the various hazards that are present when caring for patients are briefly discussed to put the hazards associated with medical radiation use into context. It is emphasised that within the context of the Medical ALARA culture, the requirement of ensuring the adequate diagnosis and optimal treatment of the patient is paramount.

Introduction

The ultimate goal of any healthcare facility is to deliver high quality, safe and patient oriented medical care. We all know that this ultimate goal can be very difficult to fulfil for each and every patient as there is a large variety of hazards that may hinder its fulfilment. In order to appreciate the importance of ionising radiation as used for healthcare in both diagnosis and therapy, and also its relative contribution to the overall hazards in the healthcare environment, the types of hazards present as well as the adverse events they may invoke are presented in this article. This is to emphasise the relevance of radiation protection as an indispensable component of safety culture and the increasing need over the last few years to develop a Medical ALARA Culture within the healthcare environment.

Hazards within the Healthcare Environment

There are very many hazards associated with a healthcare environment. For example, the Occupational Safety and Health Administration (OSHA) of the United States of America classified the potential hazards in a hospital into a number of categories [1]. These hazards can affect the patient and the staff as well as other persons present within the hospital and are listed here in a risk-related order. Each of these hazards can also be the underlying cause of a medical error and consequently, the concept of minimising the hazard can also reduce overall risks.

Biological

Biological hazards are the infectious/biological agents, such as bacteria, viruses, fungi, or parasites that may be transmitted by contact with infected patients or contaminated body secretions/fluids. Common examples include the Human Immunodeficiency Virus (HIV), vancomycin resistant enterococcus (VRE), methicillin resistant staphylococcus aureus (MRSA), hepatitis B virus, hepatitis C virus and tuberculosis.

Chemical

Chemical hazards are the chemicals that are potentially toxic or irritating to the body system, including medications, solutions, and gases. Examples include ethylene oxide, formaldehyde, glutaraldehyde, waste anaesthetic gases, hazardous drugs such as cytotoxic agents and pentamidine ribavirin.

Physical

Physical hazards are the agents within the work environment that can cause tissue trauma. Examples include ionising radiation including radiation beams and unsealed radionuclide sources, lasers, ultraviolet light, noise, electricity, extreme temperatures and also workplace violence.

Psychological

Psychological hazards are defined as the factors and situations encountered or associated with the job or work environment that create or potentiate stress, emotional strain, and/or other interpersonal problems. Examples found in the health care environment include stress, workplace violence, shift work, inadequate staffing, heavy workload and increased patient acuity.

Environmental, Mechanical/Biomechanical

This group concerns the factors encountered in the work environment that cause or potentiate accidents, injuries, strain, or discomfort. Examples include tripping hazards, unsafe/unguarded equipment, air quality, slippery floors, confined spaces, cluttered or obstructed work areas/passageways, forceful exertions, awkward postures, localized contact stresses, vibration, temperature extremes, repetitive/prolonged motions or activities, lifting and moving patients.

From the list above, one may conclude that the hospital is, potentially, a highly dangerous environment in which to be treated, to work, or simply to be present. Indeed, ionising radiation is only one of this long list of hazards and sometimes, when the radiation risks are carefully controlled, one can understand why some hospital managers have a higher priority concerning the control of some of the other, even more deadly, hazards. However, managers in hospitals have the responsibility to ensure that all these hazards are eliminated or at least minimised as much as possible taking into account the required outcome – the safe and complete healthcare of the patient.

Quality and Safety Culture

Many models and systems for quality and risk management have been developed and implemented in an effort to mitigate the hazards and errors within the healthcare environment so as to improve the safety of the patients and staff. These have proved to be effective within individual departments but do not necessarily present the desired effect in improving the safety of the patient within the healthcare facility as a whole. Successful patient treatment depends on the collective effort of many departments, in providing for example, laboratory test results, diagnostic imaging examinations, surgical procedures, radiotherapy etc. All departments must work together with this common aim.

More recently, Quality Management systems have been implemented that do involve the whole healthcare facility based on “Integrated Risk Management Systems” [2]. These systems consist of a large number of parts and use tools that need to be implemented effectively. However, such systems alone cannot be effective if the healthcare facility employees do not adopt a Quality and Safety Culture [3] before such systems are implemented.

The analysis of the above systems is beyond the realm of the present article whose focus is that the use of ionising radiation is a physical agent that comes with associated hazards and should be subject to the Medical ALARA culture. The management of the risks (and even potential errors) associated with ionising radiation needs to be implemented as an integral component of the whole healthcare facility Quality Management System.

Medical ALARA Culture

There is, as yet, no universally agreed definition of an ALARA culture, despite the wide acceptance of the need for such a culture [3]. However, the European ALARA Network has proposed a definition of the ALARA culture as an approach to the Radiation Protection Culture [4].

To understand how such an ALARA culture can be developed within the healthcare environment as a Medical ALARA culture, we need first to recall the basic principles of radiation protection.

It is commonly known that to be acceptable, radiation use must fulfil the following basic principles: 

• Principle of justification
  The benefits of using radiation must outweigh the risks.


• Principle of optimisation
  Radiation exposure from the use of radiation must be kept as low as reasonably achievable (ALARA), consonant with the desired medical outcome.


• Principle of limitation
  Obviously, the exposure of radiation workers and other individual members of the public (bystanders) must not exceed the relevant dose limits but it must be recognised that the principle of limitation does not apply to patients or their personal “comforters and carers” undergoing the medical exposure.

This is why a Medical ALARA culture is so important for medical exposures and should help to ensure that the outcome of the diagnosis or treatment will do more good than harm.

In Europe, it is a legal obligation to ensure all the above basic principles are fulfilled for any new installation or procedure using ionising radiation to operate safely [5] within the healthcare environment [6].

A discussion follows on how the basic principles, are applied in the healthcare environment. The discussion starts from the principle of justification, then optimisation and finally limitation, responding to the special situation faced in the healthcare environment that revolves around patients.

Principle of justification for medical radiation exposures

Justification is the process of ensuring that the benefits from an activity outweigh the harm resulting from that activity. In terms of medical radiation exposures, there are three levels of justification, the first of which results from the decision that medical exposures (in general) do more good than harm, and this is usually taken for granted.

The second level of justification (often called generic justification) is concerned with whether a specified procedure will be beneficial or not for a given subset of patients and will not involve unacceptable risk to the health workers involved in the procedure. Consideration also needs to be given to possible exposures of bystanders, i.e. members of the public who may be inadvertently exposed because of the procedure, and also to the patient’s comforters and carers who are willingly and knowingly exposed, having been informed of the potential doses and associated risks. Referral criteria [7] are an important tool in the practical implementation of the principles of second level justification in diagnostic imaging.

Justification at the third level is justification of the individual exposure. This level of justification must be carried out through consultation between the radiological medical practitioner and the referring medical practitioner, and may go beyond the requirements for the second level of justification.

To illustrate this, one can consider the case of a simple screening / diagnostic procedure. Mammography is widely accepted as an essential tool to screen for and characterize breast cancer. In the case of screening the second level justification process may entail just a confirmation that the person to be screened fits into the patient group for whom the procedure is deemed justified i.e. is female and is in the recognised age range for the benefit to outweigh the risk of cancer induction (assuming that the doses are properly controlled). In addition, the person justifying the examination must be satisfied that the information requested is not already available because the patient has recently undergone the same examination elsewhere, and so a further radiation exposure can be avoided (Medical ALARA Culture).

Third level justification at the individual level may be illustrated as follows. Consider a female of age lower than the recognised age range for the benefit to outweigh the risk of cancer induction but who has a history of breast cancer in the family. In this case although the procedure is not justified at the second level it is so at the third level.

Principle of optimisation

Optimisation implies that, once the procedure has been justified, every effort is taken to optimise the exposure for the procedure. For example, the equipment emitting ionising radiation is calibrated and maintained so as to provide the required end-product by using the minimum radiation possible to achieve the medical aim. This will involve acceptance testing by the provider of the equipment and confirmation by a Medical Physicist who will usually commission the facility prior to its use on patients. At this stage, specific optimisation procedures may have to be developed to find the best possible operational parameters. The result of these activities is equipment that is optimised to produce the required output for each diagnostic or therapeutic procedure. The values for each performance indicator obtained during the acceptance testing and the commissioning of the equipment are used as the base values for the periodic routine quality control tests. The cycle of quality control tests, preventive maintenance, corrective maintenance and finally replacement of the equipment is continuous through a defined periodic programme throughout the useful life of the facility.

In the healthcare environment, we then need to optimise the positioning of each individual patient and to refine the exposure parameters based on the patient’s anatomy, age and weight so as to keep the dose ALARA and at the same time achieve the required diagnostic or therapeutic outcome of the procedure. An effective quality assurance tool for confirming that diagnostic doses are indeed ALARA for the patient requires procedures for recording doses to standard sized patients, or alternatively, a large amount of patient dose data automatically collected from digital images. These data can then be compared with national, or international diagnostic reference levels. However, this is only effective if the images are of adequate quality to enable an accurate diagnosis. In therapy, even more care has to be taken to ensure that the prescribed doses are delivered correctly to the tumour with the surrounding tissue receiving doses that are ALARA; this is not easy to achieve in the field of radionuclide therapy using unsealed sources in the body.

The recent evidence that exposure to low doses of radiation, such as those received by patients during radiodiagnostic procedures, increases the risk for cardiovascular diseases [8] have made it imperative that awareness campaigns take place in all healthcare facilities to highlight the importance of optimisation for each individual patient exposure. The emerging evidence of increased lifetime attributable risk (LAR) of cancer onset from low doses [9, 10] has also contributed to the above need. The practical aspects of ALARA include limiting the exposure only to the part of the patient’s body that we need to examine or treat, by protecting all the other body parts where practicable but without negating the desired medical outcome.

With the recent increasing awareness of the importance of radiation protection and because higher quality images often entail higher doses, a paradigm shift can be observed in radiology in particular from the principle of “image quality as good as possible” to “image as good as needed” [11]. This constitutes evidence that optimisation is now being interpreted better within a Medical ALARA Culture.

Of course, when a new facility is planned, the optimisation process, with regard to workers and the general public starts at the planning stage. To ensure the maximum protection the facility should be designed to offer the necessary radiation shielding according to the occupancy of the areas around, above and below the installation to keep doses ALARA.

Principle of limitation

It is a legal obligation to restrict the doses resulting from the radiation exposure of workers, apprentices, students and members of the public (other than patients and their comforters and carers) to ionising radiation to below the limits stipulated in legislation [5].

Here we need to provide shielding to the users and other medical workers that need to be in the room during the use of ionising radiation (this is particularly important for interventional procedures). The emerging evidence that interventional radiologists could suffer from radiation-induced cataracts [12] indicates that greater care is required for the more radiosensitive organs.

It is important to note that the only situation in which ionising radiation is deliberately used to expose humans, above accepted radiation levels that are known to cause biological effects, is in the healthcare environment. For medical reasons there can be no legal limit to the dose a patient can receive, and as a consequence the dose from the procedure to each individual patient must be justified and optimised. This is the basis of the Medical ALARA culture.

Discussion and Conclusions

To achieve a Medical ALARA Culture, it is important to establish a safety-based attitude in every individual healthcare worker so that radiation protection and radiation accident prevention are regarded as a routine part of everyday duty. This objective is primarily achieved by education and training, by encouraging a questioning and learning attitude, and also by a positive and cooperative attitude from management. The national authorities can have a significant role and major impact in achieving this by providing adequate surveillance and advice.

A feeling of responsibility can only be achieved if the healthcare professionals are themselves involved in the formulation of the rules and regulations that are necessary, so that they can thus recognise and accept that these are a support to and not a hindrance in their daily work. For an effective Medical ALARA Culture, the efforts of various categories of personnel engaged in the medical use of ionising radiation must be coordinated and integrated, preferably by promoting teamwork, where every individual is well aware of their individual and corporate responsibilities through a formal assignment of duties.

Medical ALARA Culture must fit in with, and be complementary to medical practice rather than being regarded as an external requirement.

We have presented arguments that support radiation protection and a Medical ALARA Culture to mitigate against the risks from the use of ionising radiation in healthcare. However, it should be remembered that a Medical ALARA Culture is part of the wider safety culture in the healthcare environment and an “Integrated Risk Management System” can be key for a successful healthcare Quality Management System.

References

[1] OSHA, “Categories of potential hazards found in a hospital”, available at: http://www.osha.gov/SLTC/healthcarefacilities/hazards.html, as accessed on the 22^nd of August 2010.

[2] Graham, A., “Integrated Risk Management Implementation Guide”, available at: http://post.queensu.ca/~grahama/publications/TEXTPDF.pdf, as accessed on the 22^nd of August 2010.

[3] Schmitt-Hannig, A., “EAN Working Group on ALARA Culture”, European ALARA Network, available at: http://www.eu-alara.net/index.php?option=com_content&task=blogsection&id=9&Itemid=119, as accessed on the 22^nd of August 2010.

[4] EAN, “EAN proposal: Definition of the ALARA Approach to Radiation Protection Culture”, available at: http://www.eu-alara.net, as accessed on the 22^nd of August 2010.

[5] European Commission, Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising form ionising radiation, OJ L159, 29.6.1996, p. 1–114.

[6] European Commission, Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the dangers of ionising radiation in relation to medical exposure, and repealing Directive 84/466/Euratom, OJ L180, 9.7.1997, p. 22-27.

[7] European Commission, Radiation Protection 118, “Referral guidelines for imaging”, Directorate-General for the Environment, 2000.

[8] SHIMIZU, Y., KODAMA, K., NISHI, et al, “Radiation exposure and circulatory disease risk: Hiroshima and Nagasaki atomic bomb survivor data”, 1950-2003, BMJ. (Jan. 2010).

[9] SMITH-BINDMAN, R., LIPSON, J., MARCUS, et al., “Radiation dose associated with common computed tomography examinations and the associated lifetime attributable risk of cancer”, Arch. Intern. Med. 169 22 (Dec. 2009) 2078-2086.

[10] MULLENDERS, L., ATKINSON, M., PARETZKE, H., et al, Assessing cancer risks of low-dose radiation, Nat. Rev. Cancer 9 8 (Aug. 2009) 596-604.

[11] Uffman M., Shaefer-Procop C., “Digital radiography: The balance between image quality and required radiation dose”, European Journal of Radiology 72 (2009) 202-208.

[12] CIRAJ-BJELAC, O., REHANI, M.M., SIM, K.H., et al, “Risk for radiation induced cataract for staff in interventional cardiology: Is there reason for concern?” Catheter. Cardiovasc. Interv. (Jun. 2010).