Introduction
There is a rise in the number of radiotherapy facilities in India for the treatment of cancer. These facilities are regulated by the Atomic Energy Regulatory Board (AERB), India. One of the primary objectives of this regulation is to protect the health of individuals, and the environment from the risk of use of ionising radiations in the facilities. AERB considers this ‘risk’ in line with the glossary of International Atomic Energy Agency as ‘A multi-attribute quantity expressing hazard, danger or chance of harmful or injurious consequences associated with an actual or potential event under consideration. It relates to quantities such as the probability that the specific event may occur and the magnitude and character of the consequences’. 1 , 2 To achieve the goal of radiological protection from such risk, AERB regulates the facilities through the enforcement of regulatory requirements. The following establish these regulatory requirements:
∙ Atomic Energy Act 1962 3
∙ Atomic Energy (Radiation Protection) Rule 2004 4
∙ Surveillance procedures for medical application of radiation 1989 5
∙ Safety code on radiation therapy sources, equipment and installations 6
∙ Safety code on safe transport of radioactive material 7
∙ Testing and classification of sealed radioactive sources 8
∙ Safety guide on security of radioactive sources in radiation facilities 9 and
∙ Safety guide on security of radioactive material during transport 10
It is the responsibility of facilities to establish the radiological protection systems according to the regulatory requirements of AERB.
Although the radiotherapy practice in India is more than five decades old, there is still limited availability of literature on the establishment of radiological protection systems. Further, a lack of data on radiotherapy incidents in Asian countries has been reported elsewhere. 11 The studies in other countries found that radiotherapy practice, sometimes, experienced the risk of recurrence of tumour, toxicity and even fatalities among the patients, who received incorrect dose.Reference Chang, Cheetham and te Marvelde 12 – Reference Stavem, Brøgger and Devik 16 Also, it has been reported about the incidences of overexposure, radiation injuries and even death among workers in some facilities. 17 Sir Liam Donalson, Chair, World Alliance for Patient Safety also observed radiotherapy practice as ‘Radiotherapy is widely known to be one of the safest areas of modern medicine, yet, for some, this essential treatment can bring harm, personal tragedy and even death’. 11
It was found that risk of incidents occurring in radiotherapy was associated with the lack of communication, lack of technical skill, working practices of the workers, ignorance of safety warnings and risk perception of management and their pressure on the continuation of works despite failure in safety systems. 13 , 14 , Reference Nénot 18 Further, the available literature in radiotherapy practices did not reveal in detail about the influence of social factors (SF) on defining risk and decision-making processes in the implementation of regulatory requirements. Many researchers mainly from the social sciences, found that SF like risk perception, attitude, working behaviour, work coordination, communication, hierarchy and work pressure played a vital role in shaping the same physical risk, and played a significant role in the decision-making processes for implementation of regulatory requirements.Reference Covello, Slovic and Von Winterfeldt 19 – Reference Stenzel 31 It was found that the physical risk, defined by natural scientists underwent attenuation and amplification according to risk perception, communication and political interest. Barke et al.Reference Barke and Jenkins‐Smith 32 also found that even the scientist exhibited different risk perceptions on the same physical event. Interestingly, they observed that scientists in the same discipline had different perceptions according to demographic factors. In other studies, BrandenReference Johnson 33 found the shaping of risk by the risk perception of the institution and scientists based on their political interests. Many individuals, including technical experts, exercised risk perception and heuristic approaches for the immediate assessment of risk, even though it led to severe errors in the estimated risk.Reference Tversky and Kahneman 34 , Reference Finucane, Alhakami, Slovic and Johnson 35
The present study attempted to understand how SF influenced the implementation of regulatory requirements for establishing radiological protection systems in facilities located in North Eastern (NE) India. Further, it also attempted to examine the nature of the risk being experienced in the facilities. The multidisciplinary risk assessment approach was adopted in this study. In this study, facility shall mean radiotherapy facility. It may be a part of the institution, having multidisciplinary facilities or a facility solely dedicated to the treatment of cancer patients. Equipment shall mean equipment that generates ionising radiation, such as teletherapy machines, brachytherapy machines, simulators and computed tomography. The actors shall mean regulator, manufacturer of equipment, supplier of equipment, the employer, and administrator of facility and workers. The regulator shall mean AERB, Government of India. The administrator shall mean staffs assisting the employer in the administration of the facility. The worker shall mean radiation oncologist, radiological safety officer (RSO), medical physicist and radiotherapy technologist.
Materials and Method
Study site
The study was carried out in nine radiotherapy facilities located in Imphal (Manipur), Dibrugarh (Assam), Guwahati (Assam), Jorabat (Assam), Silchar (Assam), Shillong (Meghalaya), Agartala (Tripura) and Aizwal (Mizoram) of NE States, India. The average distance among the facilities was within the range 10–1,000 km. Assam has the maximum number of facilities in the region. It has six facilities, out of which three facilities were government institutes, one facility was autonomous institute and the remaining two facilities were private institutes. There was only one facility in each of the states of Manipur, Meghalaya, Mizoram and Tripura. These nine facilities were selected from out of 13 facilities available in the entire NE India, based on a minimum of 3 years of experience in the treatment of patients. Further, selections of facilities in NE states were based on the following factors:
(i) Far from the headquarter of AERB, Mumbai: The facilities were located about 2,000–3,000 km away from the headquarter of AERB, Mumbai.
(ii) Non-availability of service provider, supplier of equipment in the region and
(iii) Socio-political instability of region due to frequent general strikes and blocking of the normal functioning of offices and militant conflict.Reference Kumar and Bhasker 36 – Reference Shimray 38
Method
The conceptual framework used in this study is shown in Figure 1. This framework consists of three parts: radiological protective systems (RPS), regulatory system and SF. The RPS is to be established in the facilities as per the regulatory system of India. 3 – 10 , 39 The components of RPS covered in the present study are shown in Figure 1. The second part, the regulatory system as shown in Figure 1 consists of three components, which are used as a tool by AERB for regulating the facilities. 3 – 10 , 39 The study considered that the establishment of radiological protection systems in conformity with the requirements of the regulatory system primarily protected the worker, patient and public from the risks associated with the use of ionising radiations. The existence of the components of RPS and regulatory system in the facilities were assessed using a semi-structured questionnaire (Table 1). This questionnaire was derived from literature reviews on the regulatory system of India, IAEA safety standards/guides, and radiotherapy accidents. 4 , 13 , 39 – 41
The SF, the third part of this framework, is used to understand how the RPS and the regulatory system change under the influences of SF. The components considered are shown in Figure 1. These include perceived risk, communication of risk, working behaviour, attitude, work pressure, work coordination and hierarchy. Perceived risk is further considered as a function of knowledge, experience, trust and demography. These terms are explained in the literature elsewhere.Reference Covello, Slovic and Von Winterfeldt 19 – Reference Singh, Jayaraman and Sharma 30 , Reference Cha 42 An in-depth interview questionnaire was developed based on the above literature. The contents of the questionnaire are provided in Table 1. To minimise the influence of the contents of the questionnaire on the response of the workers, interviews of the workers started with the questions: the thoughts and images that came to their mind when they heard the word ‘radiation’, followed by their risk perception on radiation before and after working in the radiotherapy facility. The study interviewed 45 workers. They were selected from the 88 workers, which were registered with the regulator. Five workers were selected from each facility. They included a radiation oncologist, RSO, medical physicist and radiotherapy technologist. In some facilities, the medical physicist also served as RSO. In total, the researcher interviewed nine radiation oncologists, nine RSO, nine medical physicists and 18 radiotherapy technologists for this study.
Results
The status of facilities regarding the availability of equipment, workers, patient workload and treatment modalities are given in Table 2. The total number of workers in nine facilities was 88 comprising of radiation oncologists, RSO, medical physicists and radiotherapy technologists. The number of medical physicists was the lowest in the facilities as compared with another category of workers. It was due to the recruitment of a minimum number of medical physicists required in the initial functioning of the facility as per regulatory requirements, and inordinate delays in the decision-making process for updating the requirements after initial recruitment. In a facility having only one medical physicist, the dual functions of medical physicist and RSO were carried out by a single medical physicist. However, in one facility, more than two medical physicists served as medical physicist cum RSO. Employing more than two RSO in the same facility was not to paralyse the duties of the RSO, instead to share the assigned duties if the need arises.
Note:
a In addition to medical physicist registered with AERB, the facility has trainee medical physicists.
Regarding the gender distribution among facilities, there were a lesser number of women in the profession of radiotherapy practice, constituting only 13.6% (12 women workers) of the total workers. The number of women radiation oncologists was four, and they were found to be working in three facilities only. There was only one woman medical physicists found to be working. The remaining seven women workers were radiotherapy technologists, having less than 6 years of working experience in the facilities.
The educational qualifications of these workers were in accordance with the requirements mentioned in the AERB safety Code. 6 The radiation oncologists held a postgraduate degree in radiation therapy/radiation oncology. Some of the oncologists had more than 20 years of working experience in the field. The medical physicists held Diploma in radiological or medical physics, after a postgraduation in science. In addition to the required educational requirements, two medical physicists held a Ph.D. degree. The RSO in the facilities were the medical physicists, approved by the competent authority of the regulator. The radiotherapy technologists had a graduate degree in science as educational background, followed by a 2-year course in radiation therapy technology.
The workers had familiarisation with the AERB and the majority of them accessed its website for updating knowledge of regulatory requirements. They were aware of the use of personal monitoring devices (PMD) during work procedures. In India, the annual permissible dose limit for the worker is 20 mSv averaged over 5 years, and 30 mSv is the maximum annual permissible dose limit. The workers were aware of these limits.
It was observed that the workers had the perception that the societal benefits of radiation, in particular to the healthcare sector was more than the risks likely to be encountered during practice. They felt that such practice would continue to expand through the development of new technologies. The workers perceived that the risk associated with radiotherapy practice could be controlled through inherent safety measures and proper operational measures. The women workers, mainly technologists, showed higher levels of concern than the male worker. However, the women and male radiation oncologists exhibited similar risk perception.
Many workers, mainly from radiation oncologist and medical physicist, were also involved in research and development activities in addition to their routine duties of patient treatment. However, it appeared that the majority of workers made little effort to update their knowledge through regular reading of publications of AERB, IAEA, ICRP and UNSCEAR. However, the workers exhibited the desire for participating in training programs, workshops and seminars to upgrade their knowledge and technical skill. They had a high-risk perception in the operation of equipment without proper training, because of the increasing complexity nature of the operating systems of the equipment. However, many workers experienced difficulties in accessing training programme. A worker narrated his experience as:
In many cases, our request for participating continuing education programs was turned down on the grounds of non-availability of funds. They believed that such continuing education program was not required as there was no high risk in this practice as compared to another medical department in the facility. Our employers also do not pay much interest in making policy for continuous upgrade of technical skill of the worker.
All the facilities had adequate structural shielding of rooms, where radiation sources were being installed (Figure 2). The facilities constructed these rooms in line with regulatory requirements of AERB, and there was no any modification of rooms against the AERB approved layout plan. The dose rates in the respective areas around the shielded rooms were measured using a survey metre, and it was observed that radiation dose rates were below the limits prescribed by AERB. Thus, the primary protection of workers and the public from the risk of operating radiation source were achieved through the structural shielding of the rooms. The other operational safety feature found in the facilities were adequately functioning of an emergency switch on the control panel, door interlock system, patient viewing system and availability of T-rods in the rooms having teletherapy source.
The study found that many facilities did not calibrate radiation monitoring instruments as often as is recommended (Figure 2). Such instruments included survey metre, area zone monitor to be used in teletherapy and brachytherapy room, electrometer and secondary standard dosimeter. The non-functioning of gamma zone monitor installed in one teletherapy room was observed.
Other radiological safety problems encountered in many facilities were the non-availability of PMD, non-replacement of PMD on time, use of other worker’s PMD and improper storage of PMD. The new workers mainly used PMD of other workers. A worker narrated his experience in working without a radiation monitor as:
When I first noticed the non-functioning of area zone monitor, I was scared to enter the room because of risk involved in it. At that time, calibration due date of survey meters expired. Further, I had no PMD and used someone’s PMD. I intimated the matter to the RSO. However, the RSO needed to take advice from the higher authority of Institute before making a decision. Finally, I was instructed to continue the service. Fearing the security of my job, I continued to practice more than one month.
A senior radiation oncologist having more than 20 years of working experience in the radiotherapy facility expressed his experience in the lack of implementation of the regulatory system as follows:
We are unable to get new personal monitoring devices (PMD) on time, as the institute do not pay fees for PMD to the service provider, and hence, we are working without PMD. We have experienced suspension of treatment of patients in the facility by the regulator for violation of regulatory requirements. After the regulatory action, the institute took the initiative to implement the regulatory requirements.
The workers in two facilities also experienced similar regulatory actions. Many workers perceived that the quality assurance of the treatment units and equipment were not carried out on a routine basis and there was poor maintenance of record keeping. A worker expressed his experience in this regard as:
I feel that our facility initiated implementation of quality assurance programs in line with regulatory requirements after regulatory inspection. Earlier, it was not done on a periodic basis. Some workers feel that performance characteristics of the equipment do not frequently change as evident from their past working experience, and hence there may not be a need to doing all the quality assurance procedures on time.
A typical experience found among the workers was about the difficulties encountered during the downtime of equipment, as there was no service provider in the NE region. In some facilities, downtime of equipment continued for a week. Such downtime affected the treatment schedule of the patients, and many patients left the facility to access treatment in the other facility. In emergency preparedness, it was observed that the majority of workers had a low-risk perception about the non-availability of the display of emergency procedures. In some facilities, although emergency response planning was displayed, mock drills were not conducted as a part of preparing for an emergency response.
In many facilities, it was observed that the workers holding the lower grade post had to follow the existing working procedure due to the hierarchy effect. Due to this effect, sometimes they had to continue the practice, even in the failure of a particular safety component or violation of the regulatory requirements. Although such cases were situational and temporary, it increased anxiety and worry levels among the workers. Although the facilities were located in an unstable socio-political region, the facilities were open during the general strikes or any other social unstable situations and did not interrupted the treatment schedule of hospital-based patients. However, it mostly affected the patients who travelled into the facility. The workers experienced a prolonged interruption in the treatment schedule of outdoor patients and increased anxiety levels among the patients. The workers also did not experience any undesirable threat to the treatment room or during the transportation of radioactive material.
The facilities were found to communicate regularly with the regulator. The communications were mainly between the RSO of facilities and the regulator. With the introduction of an online licensing system called e-licensing of radiation applications by the regulator in the last 4 years, communication between facilities and the regulator are on the rise. In addition to this communication, the regulator inspected the facilities physically once every 3–5 years. 39
Discussion
The facilities in NE India had the necessary regulatory infrastructure such as adequate structural shielding rooms, qualified workers, monitoring instruments and quality assurance tools. However, the majority of facilities had the improper management of available resources and improper implementation of regulatory requirements on time. The existence of the required infrastructure alone is not enough to ensure an adequate level of radiological protection systems in facilities, as evident from some accidents that have occurred in facilities elsewhere. 13 , 14 , Reference Nénot 18
The majority of facilities made little effort in use of PMD, survey metre, gamma zone monitor and keeping monitoring records. The use of expired monitoring instruments, sharing of other worker’s PMD and working in a telecobalt room without a gamma zone monitor pose a threat to achieving radiological protection. Such a practice is also a violation of the regulatory requirements. It was observed that the workers, although aware of such risk, continued the malpractices in some facilities. The continuation of such practice could introduce severe errors and mistakes in the assessment of dose received by the workers. Ortiz, P et al. (2002) also found that many radiation accidents were associated with ignorance of failure of safety warning systems and overconfidence. It is also reported that consistent neglect of regular follows up of equipment malfunction, and continuation of unsafe working practices led to the accidents. 13 , 14 , Reference Nénot 18
Another major issue observed in the facilities was the lack of management of quality assurance programs. Quality assurance of the equipment is required to ensure that the system works as per design specification of the equipment and it assures accurate delivery of the prescribed radiation dose to a tumour effectively without exceeding the tolerance dose of surrounding normal tissues. 43 It also provides safety for the workers. It has been reported that the lack of quality assurance caused more than 60% of radiotherapy accidents.Reference Novotny 44 The facilities needed to adopt carrying out of quality assurance measures on a routine basis and ensure proper maintenance of its records. Such adoption could enhance the prevention of any incidents/errors likely to be encountered.Reference Yeung, Bortolotto, Cosby, Hoar and Lederer 45
The reasons why the working practices in the facilities deviated from the regulatory requirements are sometimes intertwined among the actors involved in this practice. It was observed that the facilities tended to continue violation of the regulatory requirements, despite experiencing actions by the regulator. The majority of workers were aware of the physical risks associated with working in a radiotherapy facility having weak radiological protection systems. However, the control of such risk at the individual level was constrained by many factors such as work procedures, teamwork, work coordination, trust, communication and support from the employer.
A hierarchy system and working pressure could be a tool adopted by the institute to execute the functions of the institute to achieve their targets. However, such a system could cause pressure on the workers at lower hierarchy levels.Reference Diefenbach 46 , Reference Stoddart 47 Some workers in the facilities experienced the adverse effect of such hierarchical systems, when they were asked to work despite lack of safety functions and violations of the regulatory requirements. The workers felt unable to communicate this non-compliance to the regulator, because of possible action against them by the employer. The institute was also unlikely to report such incidents, fearing regulatory action against them and loss of reputation of the institute. It could be one of the reasons for lack of reported incidents in radiotherapy, mainly of patients receiving the incorrect doses. Work pressure experienced by some workers was another factor, which could contribute to causing an error in the work procedure and violation of regulatory requirements on a situational basis.Reference Hughes and Ferrett 24
There were different risk perceptions among the workers for implementation of radiological protection systems and other regulatory requirements in the facilities. Such different perceptions led to a polarisation of workers in favour versus against the implementation of radiological protection systems in the facility. The workers who adopted risky decision-making based on their previous work practice attempted to continue the practice, even though it violated regulatory requirements. The existence of such polarisation among the workers also affected the decision-making process in the establishments of radiological protection systems. Thus, the risk experienced was not only limited to the physical risk, but it was also about the perceived risk involved in deciding to continue the practice during the failure of radiological protection systems or violation of regulatory requirements. In these circumstances sometimes the decision was taken at higher administrative levels, based on subjective judgement.
The workers felt that the staffs in the administrative levels were not aware of the risk associated with ionising radiation. They tended to judge the radiotherapy practice as low risk in comparison with other medical practices, evident from the non-occurrence of radiation injuries and fatalities among workers and patients. Such risk perceptions posed a barrier to establishing radiological protection systems in the facilities and enhanced risk among workers and patients.
The consistent ignorance of safety recommendations of workers by the employer was a typical experience in facilities. In many instances it was perceived that too much time was required to implement safety measures and therefore, malpractices continued until intervened by the regulator. If the facility was required to stop the treatment, due to either intervention by the regulator or failure of components of equipment, the facility remained closed for many days. It affected the patients, as there was an insufficient number of facilities in the regions and because of poor road connectivity in the majority of these hill regions, patients also could not reach other facilities for the continuation of treatment.
Conclusion
The facilities in the NE regions were established in line with the regulatory requirements. The facilities had adequate structural shielding rooms to protect the worker and the public from the undue risk of ionisation radiation. They also had the workers whose educational qualifications were in line with the regulatory requirements. The workers had a positive attitude toward the use of ionising radiation for treatment of cancer. However, it was observed that the majority of workers was engaged in risky working behaviours such as the use of expired PMD, use of other worker’s PMD, improper storage of PMD, use of expired survey metres, area monitors, electrometers and not performing quality assurance procedures on a routine basis.
The study also observed the existence of a varying nature of risk perceptions among the various actors in the facilities and this influenced the decision-making process of the facilities for practicing radiotherapy in accordance with regulatory requirements. Such working conditions are likely to increase the risk of delivering an incorrect radiation dose. It may also cause risk to workers in the occurrence of incidents/accidents in the facilities. Some workers were not worried about such working conditions due to their long-term experience of receiving a permissible dose well below the annual permissible dose limit set by the regulator, and also, non-occurrence of radiation injuries or fatalities in the facilities. The workers who had high-risk perceptions about such working scenarios, also appeared to continue risky working behaviours. This may be due to many factors like hierarchy effect, work pressure and involvement of teamwork in controlling risk.
The study found that the facilities need to explore various means including narrowing the gap that existed in respect of perceived risk (within the facilities), communication between the facility and the regulator and to enhance work coordination and trust among workers. The adoption of an institutional policy for conducting an internal audit of the work practices, encouragement of workers to participate in continuing education programs could enhance effective utilisation of already existing infrastructure/equipment and work procedures including quality assurance programs. The study suggests to include SF such as risk perception, communication and behaviour of workers in the risk assessment approach of the facilities, and prescriptive approach of the regulator, which are to be used in the regulatory inspection of facilities.
Acknowledgements
The author would like to thank Prof. T. Jayaraman, Tata Institute of Social Sciences, Mumbai for his guidance and support throughout the study. The author would like to thank Dr P.K.Dash Sharma, Head, Radiological Safety Division, AERB, Mumbai for his support in the Ph.D. Programme. The author wishes to thank Dr Balamurugan Guru, Dr M. Parivelan, Dr Nirmalaya C. and Shri Rakesh Khwairakpam of Tata Institute of Social Sciences, Prof. Paul Slovic, Decision Research, Eugene, USA, Dr Guneshwor, Bhabha Atomic Research Centre, Mumbai and Dr T. Priya Devi, Mumbai, India for their valuable suggestions in this work. Any opinions and findings in this piece of works are of the views of authors and are not necessarily related to/reflected by any individuals/institutions including AERB, Mumbai, India.
Conflicts of interest
There is no conflicts of interest.
Ethical standards
The author took prior consents from all the participants for the study. They were informed in advance that they have the right to withdraw their participation at any time during the fieldwork, and not to answer the questions, which would be against their personal/institute’s interest. The author agreed that collected data would be used for the academic purpose, and would not reveal the name of the participants and their institutes.