An Investigation into the Status of Quality Assurance and Quality Control Measures in Diagnostic X-ray Departments in Malawi. Harvest M.

Transcription

1 An Investigation into the Status of Quality Assurance and Quality Control Measures in Diagnostic X-ray Departments in Malawi Harvest M. Chinamale

2 AN INVESTIGATION INTO THE STATUS OF QUALITY ASSURANCE AND QUALITY CONTROL MEASURES IN DIAGNOSTIC X-RAY DEPARTMENTS IN MALAWI By Harvest Mathias Chinamale A dissertation submitted to the Faculty of Health Sciences, University of Johannesburg, in fulfilment of the requirements for the MASTERS DEGREE OF TECHNOLOGY IN RADIOGRAPHY (DIAGNOSTICS) Mrs. Jenny Motto (Supervisor) Mr. Paxton Zozie (Co-supervisor) August 2010

3 Declaration I, Harvest Mathias Chinamale, hereby declare that this dissertation is my own work. It is being submitted for the Masters Degree of Technology at the University of Johannesburg. It has not been submitted before for any degree or examination in any University.

4 Acknowledgements I would like to extend my sincere gratitude and appreciation to the following: My supervisor, Mrs. Jenny Motto and co-supervisor, Mr. Paxton Zozie for their invaluable guidance, objectivity, encouragement and making time for me throughout the project. The Canon Collins Trust, (Cape town) for financial assistance and WREFT for the donation of a densitometer and sensitometer. This equipment will go a long way in helping with the interpretation of results from QC tests that will be done in X-ray Departments across Malawi when QA programmes are instituted. Statistician, Ms Juliana Van Staden for helping with the statistical analysis of data. The Radiographers, Maintenance Officers and Hospital Administrators from hospitals that participated in this study without whom I could not have managed to acquire data. The University of Johannesburg Library management and staff for their assistance and support throughout the project. The Ministry of Health in Malawi for allowing me to conduct the study in various hospitals. Finally, but not the least, my wife Anna and children Mphatso, Alinafe and Tithokoze for their love and support throughout the project.

5 Abstract There is varied X-ray equipment in the hospitals where radiology services are being provided by the government of Malawi. Well maintained and optimally functioning X-ray equipment is essential in providing diagnostic assistance to referring clinicians. Equipment needs to be carefully looked after by the users to avoid unnecessary breakdowns because installation and maintenance is very expensive. Imaging departments need to be well run and efficiently utilised in order to minimise radiation hazards and to be cost effective. One important element of taking care of equipment is to conduct Quality Assurance (QA) Programmes and Quality Control (QC) measures. QA and QC activities are essential if X-ray equipment is to operate optimally at all times. X- ray equipment in Malawi is not subjected to any QA or QC measures as stipulated by the World Health Organization (WHO) standards and this leads to frequent breakdown of equipment. This prompted the researcher to conduct a study to investigate the status of X-ray equipment QA and QC measures in Malawi. The aim of the study was to establish the status of QA and QC measures in diagnostic X-ray departments in government hospitals of Malawi and establish a baseline from which recommendations could be made to facilitate the development of QA and QC programmes in Malawi. A quantitative design that included an exploratory and descriptive approach was used to collect data. All four central hospitals were selected using a census sampling method and ten district hospitals were selected using cluster sampling method across the country. Questionnaires were used to collect information on QA programmes for hospitals and X-ray departments. Records were checked retrospectively in the hospitals and X-ray departments for the availability of formal QA programmes if any. QC tests were also conducted on the X-ray equipment and imaging accessories.

6 Data analysis indicated that there were no QA programmes and no QA committees in place in all X-ray departments visited by the researcher. There was also no hospital QA programme and committee in all hospitals except one. Results from quality control tests conducted in X-ray departments established there was sub-optimal status of X-ray equipment in most of the hospitals. Recommendations will be made available to various stakeholders concerned with radiology services in the country to introduce Quality Assurance programmes in hospitals and to encourage the formation of a Radiation Council or Board for the country to ensure that quality services are provided. The outcome of the study will be sent to the Director of Health Technical Support Services in the Ministry of Health and heads of X-ray departments. The results, it is anticipated, will be used to put corrective measures in place in an attempt to encourage radiographers to introduce QA and QC measures for X-ray equipment and introduce QA and QC training programmes for all radiographers in Malawi.

7 Table of Contents Acknowledgements. Abstract Table of Contents List of Figures.. List of Tables List of Abbreviations List of Appendices... Page i ii iv viii ix x xi Chapter One: Introduction Background Information Rationale Problem Statement Aim of Study Specific Objectives Research Design and Methods Design Setting Sample Definition of Terms Conclusion. 10 Chapter Two: Literature Review Introduction Quality Assurance Programme and Relationship with Quality Control Measures Quality Control Measures and Tests Equipment Performance Records and Record Keeping Beam Alignment and Collimation. 25

8 Page Constancy of Radiation Output at Different mas Settings Screen Film Contact Safe Light Efficiency White Light Leakage Cost Effectiveness of a QA Programme Quality Costs Costs of Poor Quality Benefits of Quality Improvement Conclusion.. 39 Chapter Three: Research Methodology Introduction The Research Design Research Methods Population Sampling Method and Sample Size Measuring Tools Questionnaires Quality Control Tests Validity of Measuring Tools Ethical Considerations Data Collection Procedure Data Analysis Study Limitations Conclusion.. 56 Chapter Four: Results Introduction Characteristics of Study Population Results from Questionnaires from the Radiographers In-Charge. 59

9 Page 4.4 Results from Questionnaires from Maintenance Officers Results from Test Procedures Beam Alignment and Collimation Constancy of Radiation Output at Different ma and Time Settings Screen Film Contact Test Safe Light Efficiency Test White Light Leakage Test Cross Tabulations Conclusion Chapter Five: Discussion and Recommendations Introduction Demographic Data Availability of QA Committees Availability of QA Programmes Availability of QC Tests Servicing of X-ray Equipment Importance of a QA Committee Status of X-ray Equipment Performance Beam Alignment and Collimation Test Constancy of Radiation Output at Different ma and Time Settings Screen Film Contact Test Safe Light Efficiency Test White Light Leakage Test Cross Tabulation Beam Alignment and Collimation Constancy of Radiation output at Different ma and time Settings Screen Film Contact Safe Light Efficiency White Light Leakage

10 5.10 Lack of a QA Programme Quality Costs Recommendations Ministry of Health in Malawi The Hospital Management Team The X-ray Department Conclusion 109 References Appendices. 118

11 List of Figures Page Figure 2.1 Basic Cause-and-Effect Diagram. 13 Figure 2.2 The New Framework for Total Quality Management 18 Figure 2.3 Distortion of Object when X-ay Tube is off-centred Figure 2.4 Effect of Using different mas Settings. 29 Figure 4.1 Examples of QC Tests Done in Hospitals Figure 4.2 Results of Tests Reported To Figure 4.3 Benefits of QA Tests.. 64 Figure 4.4 Frequency of Equipment Services 65 Figure 4.5 Personnel Who Service Equipment. 66 Figure 4.6 Reasons for having a QA Committee.. 70 Figure 4.7 An Example of Test Film with Misaligned Beam Collimation 72 Figure 4.8 Beam Alignment and Collimation Test. 73 Figure 4.9 Constancy of Radiation Output Test 75 Figure 4.10A An Example of Test Film showing differences in Density.. 76 Figure 4.10B Test Film showing equal Densities on three Strips 76 Figure 4.11 Screen-Film Contact Test.. 78 Figure 4.12A An Example of Test Film showing Uniform Contact between Screens and X-ray Film. 79 Figure 4.12B An Example of Test Film with Uneven Contact between Screens and X-ray Film.. 79 Figure 4.13 Presence of Artefacts. 80 Figure 4.14 An Example of a Test Film with Artefacts present. 81 Figure 4.15 An Example of a Fogged Test Film from Safe Lights 82 Figure 4.16 White Light leakage Test 83 Figure 4.17 An Example of Test Film with Beam Cut-off Figure 5.1 An Example of a cause and effect diagram for lack of a QA Programme 106

12 List of Tables Page Table 2.1 Factors that Affect the Four Radiographic Qualities. 20 Table 3.1 Data Collection Exercise Table 4.1 Breakdown of Study Population according to Questionnaires 58 Table 4.2 Breakdown of Study Population according to QA Tests.. 58 Table 4.3 Availability of QC Measures and Tests Table 4.4 Availability of Hospital QA Committees.. 68 Table 4.5 Availability of Beam Alignment and Collimation Test and Correct Alignment of X-ray Beam 84 Table 4.6 Availability of Beam Alignment and Collimation Test and Centring of Mid-point of X-ray Beam Table 4.7 Availability of Radiation Output Test and Constancy of Radiation Output Test Results. 87 Table 4.8 Availability of Screen-Film Contact Test and Uniform Contact Test Results. 89 Table 4.9 Availability of Screen-Film Contact Test and Presence of Artefacts Table 4.10 Availability of Darkroom Lighting Efficiency Test and Safe Light Fogging Test Results.. 91 Table 4.11 Availability of Darkroom Lighting Efficiency Test and White Light Leakage Test Results. 92

13 List of Abbreviations ALARA CHAM CT DoH kv LBD mas QA QAC QC TQM WHO As Low As Reasonably Acceptable Christian Hospitals of Malawi Computed Tomography Department of Health Kilo Voltage Light Beam Diaphragm Milliampere per Second Quality Assurance Quality Assurance Committee Quality Control Total Quality Management World Health Organization

14 List of Appendices Page Appendix 1 Application for Permission to Conduct Research. 118 Appendix 2 Approval Letter from Ministry of Health in Malawi to Conduct Research. 120 Appendix 3 Questionnaire for Radiographer In-Charge Appendix 4 Questionnaire for Maintenance Officer/ Hospital Administrator Appendix 5 Beam Alignment and Collimation Test Procedure Appendix 6 Constancy of Radiation at Different ma and time Settings Test Procedure Appendix 7 Screen Film Contact Test Procedure. 132 Appendix 8 Safe Light Efficiency Test Procedure. 133 Appendix 9 White Light Leakage Test Procedure. 135

15 CHAPTER ONE INTRODUCTION 1.1. Background Information Health services in Malawi are to a large extent provided by the government. Other providers are the Christian Hospitals Association of Malawi (CHAM) and the private sector. The government has district and central hospitals where it provides radiology services throughout the whole country. There are a few rural hospitals where radiology services are also provided. Radiography involves working with machinery, electricity, hazardous chemicals, radiation and patients. As such every effort has to be made to ensure that a healthy and safe environment for staff, patients and the public is provided. Radiology departments provide the essential services of assisting in diagnosing various diseases. As such, the X-ray equipment in the radiology departments is expected to operate at optimum performance at all times. X-ray equipment is used to produce X-ray images (radiographs) of the human body which are then interpreted by radiologists for diagnostic information. In the process of producing radiographs, the X-ray equipment produces ionizing radiation that is hazardous to both patients and operators. Armstrong, Wastie and Rockall, (2009:15), stated that the use of unnecessary radiation should be avoided as much as possible by using the widely accepted principle of ALARA (as low as reasonably achievable). This can only be achieved if appropriate X-ray equipment is used with good radiographic technique. To provide this optimal performance, quality assurance and quality control measures are essential. Quality Goetsch and Davis, (2006:5) stated that Quality is a dynamic state associated with products, services, people, processes and environments that 1

16 meets or exceeds expectations. In their explanation, they stated that quality is ever changing and to sustain high quality an organization needs not to look at products and services of equipment only but also at the people, processes involved and the environment they are in to meet or exceed customer expectations. Montgomery (2005:4) stated that quality is inversely proportional to variability, meaning that if there is less variability in the production process, quality of the end product increases. Quality Assurance In defining QA Lloyd, (2001:1) said it is the overall management programme, put in place to ensure that a comprehensive range of quality control activities work effectively. In relation to an X-ray department a QA programme is also defined as a system of plans, tests, reviews, reports, records and actions whose purpose is to protect patients and staff from unnecessary exposure to radiation and reduce the occurrence of misdiagnosis caused by faulty equipment (Walsh Imaging, 2008:1). Carlton and Adler (2006:480) stated that Quality Assurance consists of activities that provide adequate confidence that a radiology service will render consistently high quality images and services. Quality Control The means by which, each area of interest is monitored and evaluated (Lloyd, 2001:1). Wadsworth et al. (2002:27) defined Quality Control as the regulatory process through which we measure actual quality performance, compare it with standards and act on the difference. QC is also defined as the aspect of quality assurance that monitors technical equipment to maintain quality standards (Carlton and Adler, 2006:480). The production of high quality radiographs requires that X-ray equipment and accessories are of a high standard to maintain optimum performance. This high standard must be maintained at all times for sustainable production of high quality radiographs with minimum levels of risk. Sustainability of high standard X-ray equipment for high quality radiographs can only be achieved if comprehensive QA programmes have been implemented (Lloyd, 2001:1). 2

17 According to Sungita, Mdoe and Msaki (2006:1) QA programmes ensure that there is an early diagnosis of problems that the machine may experience in the course of its operation thereby saving valuable funds that would otherwise have been used to buy expensive spare parts when the machine broke down. QA programmes for all X-ray equipment assist in having standardized imaging practices throughout all hospitals. According to Periard & Chaloner (1996:3), the main objectives of a radiology Quality Control programme are to maintain the quality of diagnostic images; to minimize the radiation exposure to patients and staff and to be cost-effective. Various checks, tests and controls must be regularly done on every X-ray machine for the programme to be achieved. This would result in having more benefits than risks from ionizing radiation. QA and QC programmes for an X- ray department involve performing regular tests on the X-ray equipment. These tests need a comprehensive programme that requires proper planning by a Quality Assurance Committee. Different tests are performed at different time intervals and require constant monitoring for QA and QC programmes to be effective. The tests are performed by radiographers who should be trained in various QA and QC programmes. In Malawi there are currently no formal QA and QC programmes being undertaken on X-ray equipment. QA and QC programmes are implemented and sometimes regulated in other countries such as the Republic of South Africa (RSA), Canada, Australia, United States of America (USA), but in Malawi it seems that QA and QC programmes are virtually non-existent and no research has been done on the status of QA and QC measures in the diagnostic departments in Malawi as far as can be established. In discussion with radiographers in Malawi, most of them said they had not performed any QA or QC measures and tests on the equipment for over five years and some for even more than ten years. There is also no radiation board or council in the country that acts as a governing body for the use of ionising radiation producing equipment. The radiology services fall under the auspices of the Medical Council of Malawi which also oversees all other 3

18 health cadres in the country. A QA programme requires a special regulatory body for the programme to be effective (Periard & Chaloner, 1996:1). This body is responsible for the implementation of a QA programme which ensures optimal use of equipment at all times. To improve the level of performance of the X-ray equipment in Malawi, several tests were conducted to establish the current level of performance of the X-ray machines. There are many QC tests that are required to be performed on the X-ray equipment but the researcher concentrated on five tests to establish the status of the X-ray equipment in terms of quality control measures. The following tests were conducted on the X-ray equipment: Beam alignment and collimation Constancy of radiation output at different milliampere (ma) and time settings Screen-film contact Safe light efficiency and White light leakage tests. (Appendices 5 9, Lloyd, 2001:30, 33, 58 and 79). These tests were selected in view of the fact that there is no sophisticated equipment and no commercial or standardised QC test tools in Malawi. The equipment in the X-ray departments in Malawi is mainly used for general radiography and a few specialized examinations. There is only one Computer Tomography (CT) machine in the country and this was excluded from the study Rationale There has never been a clear picture of the QA status of X-ray equipment in the hospitals of Malawi. The researcher is unaware of any reports on tests done in the government hospitals in Malawi. There is also no board that monitors and controls the use of radiation producing equipment. This has led 4

19 to frequent breakdown of X-ray equipment in the radiology departments. These breakdowns have led to intermittent closure of departments and subsequently no provision of radiology services to assist in the diagnosis and management of patients. As Gotbaum (2005:1-2) stated, once X-ray equipment breaks or malfunctions, the radiographic images produced may fail to properly detect a health problem, leading to a misdiagnosis, sometimes with serious consequences. The significance of taking care of X-ray equipment was also emphasized by the Institute of Vocational Education in Nampally which included maintenance and care of X-ray and darkroom equipment in the skills to be provided in its 2005/2006 course curriculum for X-ray Technicians (Goel, 2005:3). There are many causes of these breakdowns, some of which could be careless handling of the machines, and as stated by Burns (1992:22), proper care of radiographic equipment is very important since equipment is very expensive. Other causes could be the lack of regular servicing of the X-ray equipment by trained and competent maintenance personnel and the lack of spare parts for the equipment and the absence of regular QC testing of equipment. Instituting a QA programme could significantly off-set the causes of constant breakdown significantly. A QA programme ensures that tests are regularly done on the equipment so that quality of performance is maintained and undue breakdown of machines is avoided. An investigation into the status of QA and QC measures in diagnostic X-ray departments in Malawi to establish a baseline from which a training programme for QA and QC can be developed was therefore needed Problem Statement Despite the importance of a QA programme, there have been no formal QA and QC programmes that have been implemented with specific reference to X-ray equipment in government hospitals in Malawi. There is also no radiation control board or council in the country that can be used as a 5

20 governing body for the use and monitoring of X-ray equipment. So far no study has been conducted with reference to QA programme implementation in Malawi to the best of the researcher s knowledge. This descriptive study was therefore done in an attempt to establish the status of QA and QC measures in diagnostic X-ray departments in Malawian government hospitals and to use this information as a baseline for instituting QA programmes as stated in the draft copy of the Malawi Radiography Policy document that The Radiology Department shall develop and maintain a quality assurance programme in accordance with standing guidelines (Ministry of Health, 2006:2) Aim of Study The aim of the study was to establish the status of QA and QC measures in diagnostic X-ray departments in Malawi Specific Objectives To establish whether QA and QC measures and preventive maintenance tests with regard to X-ray departments are in place To conduct the following QC tests: Beam alignment and collimation test on the X-ray equipment Constancy of radiation output at different ma and time settings on X-ray equipment Screen film contact test on cassettes in use Safe light efficiency test in darkrooms White light leakage test in darkrooms 6

21 1.6 Research Design and Method Design A quantitative design that included an exploratory and descriptive approach which was also contextual in nature was used. Questionnaires were distributed to Radiographers in-charge of X-ray departments and Maintenance Officers/Hospital Administrators in various hospitals in Malawi. Tests were also done in the X-ray departments to establish the current status of performance of the X-ray equipment Setting Data was collected from all central hospitals and ten district hospitals in Malawi that have an X-ray department Sample All four central hospitals in the country were selected using census sampling as part of the sample. Ten district hospitals that have X-ray departments were also selected from the three regions of the country using a cluster sampling procedure. In total fourteen hospitals were included in the study. 1.7 Definition of Terms Quality Quality can be expressed as the state of end products that meets the expectations of clients. Quality Assurance Quality assurance is an overall management programme comprising a system of plans, checks, reviews, records and actions that ensures consistent production of quality products and services in a cost effective way. 7

22 Quality Control Quality control is a process in a QA programme where areas of interest in a system are monitored and evaluated for any variations in performance. Quality Improvement Quality improvement is the reduction of variability in processes and products (Montgomery, 2005:5). Radiographic Image Quality The total amount of diagnostically useful information resolved in an image. (Carroll, 2003:50) Radiography Radiography is a practical medical health science and in the diagnostic discipline medical imaging using complex equipment is used to diagnose the presence of pathology. Radiographer A person qualified through formal education and certification to practice medical imaging procedures and provide related patient care (Sherer et al., 2002:20). Gurley and Callaway (2006:4) defined a radiographer as a medical imaging professional who uses X-rays to produce diagnostic images. Radiograph The image which is obtained utilizing X-ray equipment and techniques from which a diagnosis is made. Ionizing radiation Radiation that produces positively and negatively charged particles (ions) when passing through matter (Sherer, Visconti and Ritenour, 2002:273). 8

23 Safelight A safelight is a light source that emits wavelengths to which particular types of film are not sensitive (Papp, 2006:35). X-ray Cassettes Holders designed to create a portable, light proof case for film, to utilize the intensifying screens to best advantage and to attenuate the residual X-ray beam as much as possible (Carlton and Adler, 2006:325). Intensifying screens By amplifying the effect of the exit or image formation radiation reaching the radiographic film, intensifying screens enhance the action of X-rays on the film. They convert X-ray energy into visible light (Sherer et al., 2002:272). kvp A unit used to measure the kinetic energy of an individual electron in the high speed beam within the X-ray tube; equivalent to 1,000 electron volts. Also used to measure the energies of X-rays (Sherer et al., 2002:273). Milliampere (ma) It is an electrical factor controlling the rate of X-ray emission from the X-ray tube (Carroll, 2003:82). Milliampere per second (mas) The product of X-ray electron tube current and the amount of time in seconds that the X-ray tube is on (Sherer et al., 2002:275). Film contrast The range of densities that the film is capable of recording (Carlton and Adler, 2006:421). Density The degree of overall blackening from the black metallic silver deposited in the emulsion of film (Carlton and Adler, 2006:400). 9

24 Fog A veil of useless density covering portions of the desired image. It is caused by randomly scattered radiation which carries no useful signal or image (Carroll, 2003:50). X-ray equipment X-ray equipment includes radiation producing equipment as well as accessories, for example, cassettes. The research will be reported as follows: Chapter 1 In chapter 1 the rationale was discussed and problem statement, the aim and objectives were formulated. Chapter 2 In chapter 2 the literature review will be discussed. Chapter 3 In chapter 3 the research design and methodology will be described. Chapter 4 In chapter 4 analyses of findings from data collected will be presented. Chapter 5 In chapter 5 results from data collected will be discussed and recommendations offered. 1.8 Conclusion Quality Assurance is an important element in maintaining optimum performance of any equipment. Machines lose their capability to optimally perform due to use, wear and tear. Without QC tests one cannot know if parts of the equipment are functioning properly or not and this may lead to constant 10

25 breakdown of equipment or incorrect output. This results in high costs of maintenance and high risk of radiation hazards for X-ray equipment operators as well as patients and the public. No formal QA programmes are known to be implemented with specific reference to X-ray equipment in government hospitals in Malawi unlike many other countries. An investigation into the status of QA and QC measures in X- ray equipment in the government hospitals in Malawi was therefore required to establish the current standard of performance. Several tests were done on the X-ray equipment, the darkroom lighting efficiency and condition of the cassettes. Questionnaires were also distributed to Radiographers in-charge and Maintenance Officers/Hospital Administrators to find out the availability of QA programmes for the hospitals. The main aim was to establish a baseline for instituting a QA programme for radiographers in Malawi. In this chapter the rationale was discussed and problem statement, the aim and objectives were formulated. The literature reviewed is discussed in the next chapter. 11

26 CHAPTER TWO LITERATURE REVIEW 2.1 Introduction A review of published research findings on a particular topic facilitates awareness of inconsistencies and gaps that may justify further research (Welman & Kruger, 2001:35). Literature has been sought on studies done and QA programmes being conducted in other areas to highlight the gaps in the Malawian context. Gill and Johnson (2002:24-25) stated that review of literature demonstrates awareness of background studies and issues relating to the project and the current state of knowledge on the subject in question. According to Creswell (1994:21), some of the reasons for conducting a literature review are to relate the study to other studies done within other areas to find out if there are any gaps and also to provide a framework for the research being done. This is also supported by Mouton (2001:86-87), who stated that there are many aims of conducting a literature review some of which include reviewing existing knowledge to find out how other researchers did in relation to the current study in question so as to learn from them what was found and the methods used. In the absence of previous research and associated literature on QA and QC measures in Malawi, current practices in countries such as the USA, Canada, Estonia, Australia, Poland, Tanzania and RSA were sourced to assess which QA programmes would be the most suitable within the Malawian context. This chapter has been divided into several sections. The first section deals with QA programmes for X-ray equipment in general and their relationship with QC measures and tests. The second part discusses the QC measures and tests that were advocated in literature for basic X-ray units. The third part of the chapter discusses literature concerning the cost effectiveness of a QA programme. 12

27 2.2 Quality Assurance Programme and Relationship with QC Measures and Tests Goetsch and Davis (2006: ) pointed out that there is a need to have a cause and effect diagram that can be used as a tool for visualizing how various factors associated with a process affect the process s output. CAUSE CAUSE CAUSE EFFECT CAUSE CAUSE CAUSE Figure 2.1: Basic Cause-and-Effect Diagram (Goetsch and Davis 2006:491) Goetsch and Davis went on to explain that the effect is a problem that comes about because of various causes within an organization. As depicted in Figure 2.1, a problem which is the effect in the diagram has factors that cause it. If the factors that cause the problem can be established and corrected, then the problem can easily be solved. Papp (2006:17) stated that it is important for an X-ray department to have a comprehensive quality management programme that consists of at least the following categories; Equipment quality control: This is a programme that deals with evaluation of equipment performance. This includes performing various test procedures on the equipment regularly to monitor its 13

28 performance. This quality control ensures the production of quality images and safety of both patients and staff. Administrative responsibilities: This deals with the establishment of processes within the department for proper implementation of tasks. This involves management and training staff for various activities, cost control, equipment acquisition and many other activities to ensure proper accomplishment of various processes. There must be responsible people to coordinate and ensure the smooth running of the QA programme. Risk management: This is a section within the department that should be able to identify possible risks to staff, patients and the public and be able to minimize these risks. This is important for health care organizations as it can prevent greater risks that can eventually deplete financial resources of an organization. Radiation safety programme: This is a specific programme that ensures that ionizing radiation is kept to a minimum for the protection of staff, patients and the general public. Though X-ray equipment provides essential services to patients, it is a radiation producing machine that can become hazardous to staff, patients and the public if safety measures are not in place. X-ray equipment is expected to be checked and inspected periodically to ensure that radiological services are not interrupted since these services are essential in providing clinicians and physicians with the necessary diagnostic information for patients. A QC programme comprises of various standardized tests that are done on X-ray equipment to monitor any changes in its level of performance. Periodic testing ensures prompt corrective action to maintain image quality and avoid undue risks of radiation hazards (Periard & Chaloner, 1996:3). 14

29 Ball and Price (2006: ), stated that a comprehensive QA programme for an X-ray department should monitor the following items; Imaging equipment which includes the X-ray tubes and generators Recording systems which include X-ray cassettes, screens and films Processing equipment that includes the X-ray film processors and safelights Reject radiographs that often indicate the problems occurring in the above three items In a study done in Canada, Periard & Chaloner, (2000:5-6) described An Inexpensive Medical X-Ray Image Quality Control Test Tool that can be used by X-ray operators in remote areas where resources and expertise are difficult to find. This kind of Quality Control procedure provides users with a simple method to check the status of their imaging systems and at the same time maintain image quality. Furthermore, Periard & Chaloner (1996:2) stated that it is a requirement for each diagnostic X-ray facility in Canada to have a quality assurance programme to control the quality of images. Legislation was enacted by the Canadian government agencies to ensure that only safe and properly installed X-ray equipment is used for the protection of patients, workers and the public. A similar set of rules were introduced by the state of Tennessee in the USA that arranged for a Basic Radiation Safety Training for X-ray Users programme in 2005 to be offered to ensure that every X-ray operator is knowledgeable enough in the operation of different X-ray machines. It was considered imperative that all operators of an X-ray machine in this state reviewed both the basic X-ray training document and the manufacturer s operation manual prior to using the X-ray machine. In addition, the state of Tennessee requires that all X-ray producing machines are inspected against a specific schedule by an inspector registered with the state (Chris-Millsaps, 2007:1-2). 15

30 Berquist (2008: ), advocated a QA concept that professionals should develop a system whereby quality improvement is measured to maintain trust of the public in the American health system. QA programmes ensure maintenance and improvement in performance of equipment and this leads to the public having confidence in a system of services because of quality outputs. Bateman and Snell (2007:12-13) stated that quality is provided when a company ensures that products and services meet the wishes of the consumers. This, they said, is because the demand for high quality products by customers keeps increasing. They further said that for organizations to provide world class quality it requires an understanding of quality in terms of product performance, customer service, reliability, conformance to standards and durability amongst others things. A survey was carried out in Estonia to assess the quality and safety measures of X-ray equipment. This was done with the aim of providing technical expertise and knowledge of modern equipment maintenance principles, affordable QC checks, increasing quality awareness amongst users and introducing quality management practices and procedures in health care institutions (Vladimirov and Kepler, 2000:1). A Training Centre of Medical Physics and Biomedical Engineering (BMTK) of the University of Tartu, provide QC services for diagnostic X-ray equipment to the majority of hospitals (Vladimirov and Kepler, 2000:2). The BMTK performs various test procedures which include the following: Constancy of radiation output; Radiographic X-ray tube tests; Radiographic table tests; Patient entrance dose rate. One of the survey s major outcomes identified that ma accuracy for more than 50% of the institutions was outside the international standard criteria rate of ±20% (Vladimirov and Kepler, 2000:2-3). 16

31 Similarly a survey in Poland was conducted and a law subsequently enacted in 2004 to ensure that all radiological facilities should conduct QA programmes. Some of the tests done include the following: entrance dose, collimation, alignment, focal spot and reproducibility of dose, time and high voltage setting (Wasilewska-Radwanska et al., 2005: 104). This again confirms that for an effective QA programme, QC tests have to be conducted to ensure quality results. In line with other countries, Tanzania developed radiation control measures. In this context Sungita et al. (2006:1) stated that the lack of QC and preventive maintenance leads to underutilization of expensive equipment making health care services less cost-effective for the country. These QC and preventive maintenance measures help in quality performance optimization. An effective QA programme requires commitment from top management and the staff involved in the implementation of QC measures and tests combined with good strategies for quality performance. According to Oakland and Marosszeky (2006:29-30), planning, people, processes and performance (four P s) form the basic model for total quality management (TQM). As represented in Figure 2.2, they devised a framework for TQM that provides management necessities for accomplishing organizational success. The TQM model is complemented with three Cs, culture, communication and commitment integrated into the four Ps framework for the organization to move forward successfully. People, planning and processes are the key areas in producing quality products and services which will eventually improve overall performance for an organization. The three Cs, culture, communication and commitment are essential components that provide a good environment for the model to work for the organizational success (Oakland and Marosszeky, 2006:31). See Figure 2.2 next page. 17

32 Planning Culture Performance Communication People Processes Commitment Figure 2.2: The New Framework for Total Quality Management (Oakland and Marosszeky, 2006:30) The framework can be used in an X-ray department setting where the X-ray staff, radiographers as well as support staff are supposed to work together in planning and implementing various processes to achieve good overall performance and to produce quality radiographs. This can be achieved if there is involvement and support from the hospital management. Top management is responsible for creating a culture of quality services by all staff in all departments. There must be commitment from all people concerned and results of performance should be communicated to all staff if quality services are to be achieved (Oakland and Marosszeky, 2006:29-30). 18

33 Evans and Lindsay (2002:91) stated that a variation from the required standards is the major cause of poor quality in products and services. Based on the Deming Philosophy, they said reducing uncertainty and variability in the design and manufacturing process ensures improvement in end products and services. The Deming Philosophy focuses on a never-ending cycle of designing, testing and selling to provide high quality products and services. These high quality products and services lead to higher productivity which in turn leads to long-term competitive strength. In the radiographic context, this leads to high quality radiographs and patient satisfaction. Uncertainty and variability of X-ray equipment can be reduced by performing regular checks and tests on the equipment to make sure it conforms to the required standards. As can be seen from the literature presented, many countries have identified a QA programme as important for sustainable quality performance of X-ray equipment. 2.3 Quality Control Measures and Tests Selective testing of each component in a system on a regular basis is essential to ensure optimum performance of any equipment. According to Wootton (1993:49) QC involves regular testing of major components within a system in a QA programme. For an X-ray system these components could be the X-ray tube that produces the radiation, accessories such as the cassettes and the darkroom where films are processed. X-ray equipment and its accessories are very expensive and should be used with care. Forster (1993:154) said that operators of X-ray equipment should be able to recognize any symptoms of faults and report any noted to avoid further damage to the machine. These symptoms can be diagnosed through routine checks on the performance of equipment. In New York, X-ray operators/owners of medical X-ray equipment are required to meet certain requirements in order to comply with New York City/Bureau of Radiation Health (NYC/BRH) regulations. Some of the requirements include the following: quarterly X-ray tube collimator tests; physics records permanently maintained and stored in the radiological physics office; film- 19

34 screen contact tests and the evaluation of cassettes annually; preventive maintenance measures to be performed on all X-ray equipment and documented annually; policy and procedures related to radiation safety must be reviewed and modified if necessary on an annual basis (Nickoloff, 1996:2-3). As can be seen, Quality Control for the X-ray department involves doing various tests on the X-ray equipment and accessories to check performance. There are many tests that can be performed to ensure adequate equipment performance. Each test has its importance relative to a particular component of the equipment. These tests will ensure adequate monitoring and maintenance of the equipment that will make the production of quality radiographs possible. For continuous improvement of quality production of radiographs, these tests should be performed routinely (Papp, 2006:193). Wallace (1995:4-6) came up with four radiographic qualities that are very important and need to be checked on a radiograph. These are density, contrast, distortion and recorded detail. Table 2.1 Factors that Affect the Four Radiographic Qualities (Wallace 1995:4-6) Factors affecting Radiographic Qualities Radiographic Qualities Density Contrast Recorded Detail -mas -Beam -Screens -Films restriction -Films -Screens -Processing -Contact -Beam -Films -Motion restriction -Processing Distortion -Object alignment, -Film alignment, -Central ray alignment He further said that there are many factors that control or influence these radiographic qualities which need to be investigated to ensure the production 20

35 of quality radiographs. Some of the factors that affect the radiographic qualities are listed in Table 2.1. As can be seen in the table, some factors affect more than one radiographic quality Equipment Performance Records and Record Keeping Records of maintenance and QC measures and tests should be maintained for all X-ray equipment in an institution. QA records help to show evidence that QC measures and tests were done and to the required standards (Oakland and Porter, 1995:109). Without records nothing can be established as to what tests were done and those that were not done. Keeping records help monitoring changes in performance of a particular part or system. All this information should be complete and easy for review by the department staff. Kidd (1992:18) stated that quality deals with preparation, execution, evaluation, improvement and correction of goods and services and is also a responsibility of the management because it involves finances, personnel, planning and safety. For an effective QA programme and proper record keeping, it is important to have a working QA committee for the hospital as well as for the radiology department. Responsibilities are assigned to various staff members of QA committees for easy monitoring and evaluation of QA processes within each department as well as the whole hospital. QA committees from different sections of the hospital collaborate and work together with the hospital management and this helps in sourcing adequate financial resources for the programme (Papp, 2006:9). Oakland and Porter (1995:101) stated that an organization needs to have an organization chart that should include responsibilities and functions relating to quality. Each area at every stage of the quality system should have responsible persons to ensure easy and quick monitoring of the process. A policy on quality should be published, well communicated, understood and implemented at all levels of the organization (Oakland and Porter, 1995:100). The Cleveland State University Department of Environmental Health and Safety in the USA developed standard operating procedures as a guide for 21

36 maintenance and use of X-ray equipment. It included a QA programme whereby the X-ray equipment is evaluated on a six monthly basis. A Radiation Safety Officer keeps all records pertaining to the safe use of X-ray equipment and has ultimate responsibility and authority to ensure that all rules and regulations are followed by all users of the equipment on the campus (Novak and Van Keulen, 2007: 2, 6). Clawson (2003:1-2) stated that more than one person should take responsibility of conducting QC tests but a QA programme coordinator should assume overall responsibility for all operations of the programme. This leads to consistency of test methods, interpretation of results and action to be taken. She also emphasized the keeping of records of QC tests performed. A QA committee for the hospital makes sure that there are QA programmes for all departments of the hospital. Such a committee ensures that the QC measures and tests from various departments are timeously and properly done and that actions are taken for any indication of variations in the performance of the equipment. A QA committee for the radiology department ensures that all QC activities are conducted according to stated requirements and standards for different machines and reports (Periard and Chaloner, 1996: 1-16). According to Stevens (2001: 6-7) a QA committee for an X-ray department ensures that there are criteria for conducting tests on the equipment. This committee is also responsible for making sure that all standards for performing QA tests are followed and tests are done in the required time. The main goal of the committee is ensuring performance improvement and production of quality images. Performance improvement means focusing on the patient and quality with the objectives of quality care of the patient and the achievement of quality radiographs. Stevens (2001:161) also stated that records and test films from the past and present should be kept when a test or corrective action is done. Records should include the person who performed the test, results of the test and whether or not corrective action was taken. Dale (2005:5) stated that there must be an agreed definition of quality for every department and individuals so that the entire organization focuses on its 22

37 objectives. This ensures that every function or activity is focused on achieving quality products and services. He further said that quality means conformance to agreed and fully understood requirements (Dale, 2005:8). He explained that quality should not be measured as low or high but must be judged to be correct or incorrect when compared to reference standards. In the same way radiographs are supposed to give a clear image of the body part X-rayed for proper diagnosis. Any radiograph that does not produce the required information on the image may give a wrong impression and this may compromise image interpretation. This can be dangerous to patients as he/she may receive inadequate or incorrect treatment. As such it is important that X-ray equipment produces quality radiographs at all times to avoid misdiagnoses and repeat radiographs having to be done. Misdiagnosis and repeats due to incorrect information provided by a radiograph can be costly to the patient as well as the department and the hospital as a whole. There is also an increase in the risk of radiation exposure to patients and staff. Every individual in the X-ray department must know the requirements needed to produce quality radiographs. This will prompt every staff member to make regular checks and tests on equipment performance which will reduce unnecessary increase in costs, as costs for non-quality are very high (Dale, 2005:19). According to Dale (2005:21) quality management has improved by simple physical inspection being supplemented by QC measures and QA programme leading to Total Quality Management (TQM). He further explained that TQM involves policy development involving all operations of an organization, team work and employee involvement. This is why it is important that the whole management team should be involved for the process to work effectively. A QC programme for X-ray equipment should be an integral part of quality services in health care. As such, there must be some kind of compulsion on the equipment owner or senior managers for them to implement such programmes. In Australia, a compulsory compliance testing programme for all X-ray equipment was introduced by the Radiological Council to ensure that all the equipment complies with accepted standards and performance criteria 23

38 (Hutchison et al., 1998:1). Compliance to the required standards and performance criteria cannot be properly checked if there are no records of results of tests done in the past. All tests and procedures conducted must be recorded for easy monitoring of performance of equipment. This ensures that follow-up tests are adjusted accordingly to acquire optimum results and corrective action is taken for equipment not functioning according to prescribed standards. In the Republic of South Africa, the Department of Health (DoH) enacted regulations to forbid the use of electronic products capable of emitting ionizing radiation without being licensed. The objective was to ensure that the public, patients and operators are protected against ionizing radiation without limiting the benefits realized from the use of such radiation producing equipment. Amongst many functions the DoH tests and evaluates new products and compiles national safety norms and standards. Any deviation from the set standards after conducting follow-up QA on the equipment can easily be noted by comparing the results with the compiled reports (South African Department of Health, 2006:1). Winston et al., (2001:2) stated that all radiation control personnel are encouraged to promote QA programmes to reduce exposure whilst maintaining and improving diagnostic image quality and to limit health care costs. A specific person is put in charge of maintaining the QA programme and allocated time, equipment and space to carry out the required activities. This person can be a QA officer or head of the X-ray department who is responsible for keeping records of all tests conducted so that subsequent tests are followed up according to required standards and schedule. These records help engineers to monitor the areas of the equipment that are not working properly and those parts that are wearing out and action taken to ensure that the equipment does not break down. Implementation of the QC tests and measures requires the establishment of proper committees for the hospital and the X-ray department so that results are recorded and actions are taken for any variations in equipment performance. In addition to QA committees, it is also vital for management to 24

39 consider training of staff for proper implementation of a QA programme. Wadsworth et al. (2002:12) stated that every responsible person for quality in an organization has to receive adequate training related to the quality of the product. This is the reason for involving top management in a QA programme to ensure there is adequate support in terms of financial resources for proper implementation of the programme Beam Alignment and Collimation The light beam diaphragm (LBD) of the X-ray machine enables a radiographer to correctly control the area to be exposed when examining a patient. This makes it possible to reduce radiation scatter thereby reducing the amount of radiation dose to the patient at the same time improving the quality of the image (Lloyd, 2001:29). According to Carroll (2003:134), there are two main purposes for the use of an X-ray beam limiting device; reducing radiation exposure to the patient and to increase the contrast of a radiographic image. According to him, limiting the size of the X-ray beam is one of the most effective ways of reducing radiation exposure to the patient because only the anatomical area of interest is exposed to radiation. The amount of scattered radiation is also dependent on the body tissue exposed. The more tissue exposed the more scatter is produced and the less tissue exposed, the less the scattered radiation (Carroll, 2003: ). As the scatter radiation is produced in all different directions some of it also reaches the X-ray film which leads to increased exposure to the film and the result is increased fog and decreased contrast and poor quality of the final radiograph. This is why it is important to ensure that the area of interest of the body part exposed to radiation is limited as much as possible. It is important that the light/x-ray field is congruent at all times as any misalignment may result in poor radiographic images. Misalignment may be caused by a shift in the light bulb filament inside the light beam diaphragm, mirror position, collimator positions on the tube head or anode focal spot (Siedband et al., 1981:18). Any malfunction of the mechanism can cause 25

40 improper performance leading to higher radiation dosage to patient and repeat images (Papp, 2006:100). The LBD is used frequently and is vulnerable and as such can be subjected to knocks that may result in inaccuracy of the light beam/x-ray beam coincidence, blown light bulbs, electrical and mechanical faults. A beam alignment and collimation test ensures that there is adequacy of the diaphragms and congruency of the light to the radiation field. Good collimation means that the X-ray field falls just within the rectangular field of the test tool used to assess the alignment of the light and X-ray beam fields. The light and the X-ray field misalignment should not exceed 2% of source to image distance (Sungita et al., 2006:3). The test should be conducted annually and whenever it is deemed necessary according to visual inspection (Lloyd, 2001:29). Stevens (2001: ) stated that the beam alignment and collimation test should be conducted when any of the LBD parts such as the mirror, collimators, light bulb or the tube have been replaced. He further advocated that records of the test including date of test, test films used and corrective action taken, if any, should be kept for comparison purposes with follow-up tests. In addition to checking the correct alignment of the X-ray beam to the light field, centring point of the X-ray beam must also be checked to ensure that the central ray of the beam is correctly centred to the required place. This is important because whenever the central ray is not perpendicular to the object in question there is some distortion of the part being X-rayed and the further away an object is from the central ray the greater the distortion (Carlton and Adler, 2006: ). It is, therefore, important to ensure that the centre point projected by the light field is the same as that of the central ray of the X- ray beam. If the X-ray beam is not centred to the light field centring point it is like angling the tube away from perpendicular and the anatomical part of the body being X-rayed becomes distorted (Carlton and Adler, 2006:463). Carroll (2003: ) stated that there are four main factors that affect shape distortion: the shape and thickness of the body part being X-rayed; the centring of the central ray of an X-ray beam; the angle formed between the 26

41 central ray and the central axis of the object; and the angle formed between the long axis of the body part being X-rayed and the long axis of the film. On the centring of the central ray it was stated that off-centring places the object in question at an angle which results in image distortion as depicted in Figure 2.3 below. X-ray Tube A B Objects Images Figure 2.3: A schematic diagram to illustrate distortion of object when X-ray tube is off-centred As shown in Figure 2.3 object A produces an image of shorter length than a similar object X-rayed at angle because of off-centring of the X-ray tube in B which produces an image longer in length. In this case the images are distorted if the X-ray tube is off-centred from the mid-point of the light field. 27

42 2.3.3 Constancy of Radiation Output at Different ma and Time Settings Radiation output is influenced by many factors some of which include kilovoltage (kv), milliampere (ma) and time in seconds. These factors, kv, ma and time must be consistent at all times in all settings for the production of good radiographic images. The amount of X-ray exposure to the film is directly proportional to the product of milliampere and time in seconds (mas). The mas value is the product of ma and time in seconds(s). An increase in mas increases the amount of exposure reaching the X-ray film. Since density of a radiographic film depends on the amount of exposure, the mas setting is used to control the density of an image on a radiograph (Carlton and Adler, 2006:403). The ma and exposure time selectors on the control panel of X-ray equipment determine the quantity of X-rays in the beam which also controls the density of the X-ray film. Selection of the same mas value at different combinations of ma and seconds is called reciprocity (Papp, 2006: 95-96). For an example; 100mA x 0.05s and 50mA x 0.1s produces the same mas of 5 mas and should ideally produce the same density on the X-ray film. According to Carroll (2003:70-71), ma and the time should mathematically be inversely proportional to each other as shown in the following formula: ma(o) ma(n) = Times(n) Times(o) (o) represents the original technique and (n) represents the new technique. By cross multiplying the formula it simply implies that: Original ma x Original Time(s) = New ma x New Time(s) This may be explained as: Original mas = New mas This formula is used when a radiographer would like to reduce or increase the ma or the time but achieving the same density on the resultant radiograph. 28

43 Millampere settings should be reliable and produce a constant photographic effect for a given mas value at varying ma and time factors with all other factors being constant (Lloyd, 2001:58). If the densities on the films from the two combinations of ma and seconds are not the same, then there is a failure on the equipment to produce correct exposure, which is called reciprocity failure (Carlton and Adler, 2006:403). According to WHO standards, this test is supposed to be conducted at the start of a QA programme, yearly and when necessary. See an example of how slight differences in mas affect the overall density of the final image on the radiograph in Figure 2.4 below. A B C Figure 2.4: Effect of using different mas settings (Ballinger and Frank, 2003:5) Figure 2.4 above shows three radiographs of the same knee x-rayed using different mas settings. Radiograph A was produced using lower mas than required, radiograph B with adequate mas for bony detail and radiograph C with a high mas setting but using the same kv. As can be seen, radiograph A is too light to make diagnosis possible while radiograph B is of adequate density and of diagnostic value and radiograph C is also not diagnostic because it is too dark (Ballinger and Frank, 2003:4-5). Fauber (2000:53) also stated that a radiograph must have sufficient density so that anatomical 29

44 structures of interest are seen clearly and the radiograph deemed optimal, diagnostic and acceptable. He further said that it is the responsibility of the radiographer to find out and solve what factors are causing the problem of density error. Modern technology that is applicable to most new X-ray units does not permit this kind of testing because they have generators which combine the ma and time to have a mas control. In Malawi most of the X-ray equipment still have separate controls for ma and time in seconds Screen Film Contact Cassettes are containers that have two intensifying screens inside that hold the X-ray film between the screens. The function of intensifying screens is to emit light towards the X-ray film after being exposed to X-radiation. The screens convert X-ray energy into light energy and it is this light energy that forms an image on the X-ray film. The main objective of using intensifying screens is to amplify the incoming radiation beam which in turn enables the use of lower exposure factors thereby reducing patient radiation dose (Carlton and Adler, 2006:318). Gunn (2002: 203) stated that objectives for performing a screen-film contact test include determining loss of contact between screens and X-ray film and the presence of scratches or abrasions which cause artefacts on radiographs. Screen-film contact should be optimum and uniform to ensure the production of quality diagnostic images. Poor screen-film contact results in patches of dark areas and localised blurring where the contact is not adequate resulting in reduced image sharpness (Lloyd, 2001:32-33). Carlton and Adler (2006:322) stated that loss of contact between the X-ray film and screens causes loss of detail and sharpness of the radiographic image. This may come about when the cassette s back and front warp or bend because of improper handling which results in diverging of light photons. Cassettes are susceptible to damage due to constant use and this results in possible wear leading to poor screen-film contact. 30

45 In some cases, loss of density or sharpness on the film may be as a result of foreign matter or debris (artefacts) inside the cassette that may block light from the screens reaching the film. This is a consequence of long use of the cassette without cleaning the inside of it (Papp, 2006:185). Carlton and Adler (2006:327) also stated that poor screen-film contact may be caused by artefacts present on the screens. These artefacts block transmission of light from the screens to the film or prohibit the conversion of X-ray energy to light energy by the screens. As Ball and Price (2006:104) said that the presence of stains, finger marks and foreign matter on screens affect their fluorescent emission. The result of this is loss of detail of the image on the areas where the light was blocked. According to Carroll (2003:45), artefacts on an image are any extra images which portray false and useless information that obscure the desired detail of a body part being X-rayed. This can be caused by dirt inside the intensifying screens. This false or useless information on the radiograph is also classified as noise. Even though screens are constructed to last many years, failure to take care of them may lead to damage and consequently loss of image quality. One way to find out if the screens are wearing out is to perform a screen-film contact test to ensure there is uniform distribution of light from the screens to the film. This test enables one to identify those cassettes with poor screenfilm contact that result in an image of poor resolution which lead to radiographs of poor quality that lack detail of the body part that has been X- rayed (Stevens, 2001:121,124). According to Stevens (2001:124), a cassette found to have poor screen-film contact should be discarded and not be used again until the screens have been replaced and tested again. Ball and Price (2006:104,260), stated that a damaged cassette may cause damage to the screens which usually are irreparable and need to be replaced. Screens and cassettes are very expensive and are costly for the department and the hospitals as a whole. According to the required performance criteria, a screen-film contact test should have darker areas no larger than 2 cm in diameter of poor contact and the test is required to be conducted every six months or when necessary (Lloyd, 2001:33). Some cassettes may only 31

46 contain one intensifying screen but in this study only cassettes containing two intensifying screens are relevant Safe Light Efficiency A darkroom is a vital link in the production of high quality radiographs. Being a darkroom, there must be a way of making it easy for darkroom attendants to do their work. Since X-ray films are not sensitive to particular wavelengths of orange-red light, a low level illumination is provided in the darkroom through the use of safelights within these wavelengths. This low level illumination is controlled by the use of specific filters, the wattage of bulbs, the number of bulbs and the distance between the working bench and the bulbs (Carlton and Adler, 2006:295). A darkroom must also have appropriate safe lighting and the lights conveniently laid out (Lloyd, 2001:78). Gunn (2002: 199) emphasized that safelights for the darkroom need to provide a suitable environment for darkroom workers with adequate illumination during processing without affecting the X-ray films. Due to wear and tear safelights are subject to cracks and other damage after long use. Incorrect wattage of bulbs used within the safelight may also lead to fogging of films (Papp, 2006:36). The poor lighting from safelights in the darkroom may lead to an increase in fog of a previously well-exposed film. According to Papp, a safelight test should be performed to ensure there is adequate and required lighting in the darkroom. Since safelights emit white light to some extent, X-ray films should not be placed under safelights indefinitely. Most typical X-ray films can remain in a safelight environment for at least 40 seconds without fogging. This means that films should not remain on the working bench for more than 30 seconds. This test should be conducted every six months or more often if there are problems noted (Papp, 2006:35). 32

47 2.3.6 White Light Leakage A darkroom ensures that X-ray films are not exposed to any white light during handling and processing. White light in the darkroom is mainly used for illumination of the darkroom area for purposes of cleaning, maintenance and possible emergencies. Unprocessed X-ray films are very sensitive to white light and any exposure to it leads to fogging of the film. During processing of X-ray films all white lights are therefore switched off and the darkroom is also supposed to be shut off from all sources of white light from outside the darkroom (Lloyd, 2001:79). Sometimes light can leak from outside into the darkroom through door frames, X-ray film hatches or where the air extractor or the film processor is installed if they are not sealed properly. Leakage may also start if the door frames or ceilings are subject to wear and tear. Such leakage can cause damage to the films during film handling in the darkroom leading to poor quality radiographs. An exposed film is more sensitive to light or radiation compared to an unexposed one. A film which has been accidentally exposed to white light before being X-rayed, leads to unnecessary increase in sensitivity of the film which leads to fog that destroys the quality of an image (Papp, 2006:33). The safelight test is complemented by a white light leakage test to ensure that there is no fogging of films from either the safelights or the white lights. Guebert et al. (1995:176) stated that a light leakage test is mainly a physical check-up for possible sources of light leakage and that the most common places for light leakage are doors, frames around processors or film hatches, ceiling tiles, light fixtures or pipes entering the darkroom. During the test one stays in complete darkness for at least 10 minutes to adapt the eyes to the darkness until one is able to see any white light leakage from outside the darkroom. As a regulation, these tests should be conducted every 6 to 12 months (Lloyd, 2001:79). 33

48 2.4 Cost Effectiveness of a QA Programme To have quality outputs an organization has to reduce deficiencies in key areas without increasing costs and eliminating essential services (Goetsch and Davis, 2006:44-45). Lack of quality is the result of failure in the production process. Failure comes when the right things are not done the first time at different stages of the process (Oakland and Porter, 1995:6). Oakland and Porter (1995:7) further said that in all organizations there is a quality chain of customers and suppliers. This is the same in a hospital setting where the X-ray department provides services by examining patients and producing radiographs for diagnostic purposes where the radiographers together with the X-ray equipment are the suppliers and the patients are the customers. It is the opinion of the researcher that this chain can be broken by one or more persons or a piece of equipment not meeting the required standards because everyone throughout the organization should be involved in the process if quality products are to be achieved. Implementation of a QA programme ensures that X-ray equipment functions properly at all times without unnecessary breakdowns which can be very expensive. As a QA programme continues to run, the costs for running the programme decreases while the equipment continues to provide services and quality products Quality Costs Cost is one measure of performance in a total quality system. Cost has to be carefully identified, calculated and analyzed in line with time in measuring the impact of an effective QC system of an organization. According to Montgomery (2005:28), there are several reasons why a cost has to be attached to quality. Some of the reasons include the following; The increase in complexity of products associated with modern technology 34

49 Awareness of the cost life cycle that includes maintenance, spare parts and field failures Communication to staff from top management with regard to cost implications Mitra (2002:21) discussed four major categories of quality costs which are; prevention, appraisal, internal failure and external failure costs. He explains that total quality costs become less in the long run and the full impact of change in the process is only felt later Prevention Costs Prevention costs are those costs incurred during planning, implementation and maintenance of a quality system. These include salaries, developmental, educational and training costs for process control techniques among others. For an X-ray department this can mean the planning phase of a QA programme that involves training of staff in QC tests, production of QC charts, and formation of QA committees Appraisal Costs These are costs concerned with measuring and evaluating products and component parts to check if they are conforming to specified standards (Mitra, 2002:21). Various components of a system are checked and tested to ensure quality end-products. In an ideal QA programme for X-ray equipment, QC tests are used to check and test various components of the equipment to ensure proper functioning and the production of quality radiographs. In relation to an X-ray department the appraisal costs may include buying of test tools, the actual testing and compiling of records of test results. 35

50 Internal Failure Costs These are costs incurred when products, materials and services fail to meet specified quality standards. These occur because of discrepancies discovered within the system after doing QC tests. Materials and labour have to be readapted to meet the required standards. In an X-ray department these costs incurred may refer to correcting the faulty components of X-ray equipment found to be inadequately functioning and thus compromising quality. Engineers and technicians have to be hired to repair the equipment to ensure it is functioning properly. Internal failure costs can decline in the long run if an effective QA programme is in place (Mitra, 2002:22) External Failure Costs External costs are those when the end-product does not satisfy the customer. These include customer complaints that involve the cost of investigation and adjustments, repair and replacements of products that do not conform to the required standard (Mitra, 2002:22). Gurley and Callaway (2006: 6-7), stated that patients in X-ray department are customers who are provided a service and that they are supposed to receive a combination of human care and provision of quality services. For an X-ray department, external failure costs are incurred where the end-product, for example, radiographs, do not satisfy the radiologists requirement for accurate interpretation of radiographic images and additional or repeat radiographs are required. These can be reduced if there is a QA programme in place to continuously produce quality radiographs. The production of quality radiographs can reduce both internal and external failure costs. To ensure quality output and effective costing, hospital management has the responsibility to introduce a QA programme for the hospital as a whole. A QA committee is important to oversee how quality is being implemented and monitored. As each department of the hospital has different types of equipment and needs, each requires a QA sub-committee to make sure that all departments needs are fulfilled. The work of the hospital QA committee is 36

51 to make a summary of total quality costs broken down into the four categories as identified. This ensures incorporating such costs into the accounts system of the hospital for total quality implementation (Mitra, 2002:23) Cost of Poor Quality Failure in any area of a process results in more failures in other parts of the system leading to more problems in quality of the finished products (Oakland and Porter, 1995:8). The same applies to X-ray equipment, if there is failure in the alignment of the X-ray beam or radiation output due to a faulty ma or time selector, this can result in poor quality radiographs even if other parts of the equipment are functioning well. In an X-ray department deficiencies in the operation of equipment can be reduced by conducting QC tests at different stages in the process of producing radiographs. This ensures optimum performance of machines and production of quality radiographs without incurring unnecessary costs caused by repeat examinations. Some of the consequences of poor quality radiographs being produced are: Radiation hazards to patients and staff caused by repeat radiographs. Repeated radiographs are a source of unnecessary patient radiation dose (Wootton, 1993:55). Wastage of films caused by repeat radiographs. Possible misdiagnosis due to poor quality radiographs Benefits of Quality Improvement Quality improvement focuses on continually improving the quality of processes or systems in place rather than just maintaining the level of quality (Papp, 2006:6-7). Papp explained that quality improvement focuses on the processes being followed and not individuals in the system. As stated by Goetsch and Davis (2006:45), quality improvement reduces overall costs of a system without eliminating essential services. Improvement of quality 37

52 reduces deficiencies in many areas of the system and this leads to improvement in product production and services rendered which leads to customer satisfaction and better net profits. Montgomery (2005:2) stated that understanding quality and taking quality as an important and integral part of a system leads to business success and growth. In his explanation, he said that key areas in a system must always conform to quality standards to successfully improve quality of the whole system. He further said that producing high quality products in the modern world is a big challenge due to the rapid evolution of technology. This requires an on-going improvement in quality for an effective QA programme which will yield increasing productivity and reduction in costs (Montgomery, 2005:27). Oakland and Porter (1995:8) stated that there are more benefits in terms of increased competitiveness, reduced costs, and elimination of wastes if there is a continuous improvement in quality. In relation to an X-ray department this means having different parts of the X- ray equipment tested regularly for the production of quality radiographs and better services to patients. Production of quality radiographs will reduce the occurrence of repeat examinations. This will in turn reduce wastage of X-ray films, unnecessary human exposure to radiation, less waiting time for patients, properly read and interpreted radiographs by radiologists and fewer machine break-downs. The goal should be to satisfy the patient, who is the customer by providing quality radiographs for proper diagnostic information as supported by Sashkin and Kiser (1993:55). In a multinational study on X-ray quality control and patient dose in 34 countries by the International Atomic Energy Agency (IAEA), the results revealed that up to 50% of X-ray examinations are of low standard quality in less developed countries requiring repeat examinations which lead to unnecessary increase in radiation exposure to patients (Keen, 2008:1). The IAEA further reported that implementation of basic QC programmes helps to improve image quality and reduce radiation dose. 38

53 Another study was done in 12 countries within Asia, Africa and Eastern Europe, to assess patient doses in radiographic examinations. The objective was to assess the quality of images and the doses to patients in terms of entrance surface air kerma. The percentage of poor images was found to be up to 53%. After conducting a quality control programme the percentage of poor images improved by 16 points in Africa, 13 in Asia and 22 in Eastern Europe. Reduction of radiation doses ranging from 1.4% to 85% were also achieved (Muhogora et al. 2008: ). This study emphasizes the importance of QA programmes for X-ray departments in both developing and developed countries. In another study done in Norway, it was found that good radiography is characterized by the combination and integration of technical and patientoriented actions (Egestad, 2008:12 16). It is further stated that for one to be a good radiographer one has to be an expert in the field. To be an expert one needs to do the right things at the right time. A radiographer has to know how to use the X-ray equipment and how to care for it as well as care for the patients to produce quality radiographs. This means combining good patient care with good use of technical equipment to achieve optimum results. Knowledge in how to conduct QA and QC measures and tests will improve the quality of services provided, thereby producing quality radiographs and reducing repeats. 2.5 Conclusion As seen from the literature reviewed, QA is an important factor in improving services for any organization. QA involves monitoring of parts of a system by conducting regular testing of levels of performance and taking corrective actions if there is a need. In an X-ray department QC involves testing of different parts of the X-ray equipment such as tube performance, processing area and X-ray accessories for example cassettes and films to ensure the production of quality radiographs and the reduction of radiation risks to staff and patients. 39

54 For an ideal QA programme, there is a need for a committee specifically dealing with quality issues for the whole hospital and sub-committees in each department for adequate implementation of QC tests and measures. The work of the committees is to make sure that all required programmes are properly run and records of activities well documented in different departments and to ensure that appropriate actions are taken for continued quality services. Involvement of the hospital top management is essential in securing enough resources for adequate financial support for the programme to be a success. In the next chapter the research design and methodology are described. 40

55 CHAPTER THREE RESEARCH METHODOLOGY 3.1 Introduction The purpose of this chapter is to document the research design and methodology used in this study. The aim of the study was to establish the status of QA and QC measures in diagnostic X-ray departments in Malawi. 3.2 The Research Design An exploratory and a quantitative design using descriptive and contextual approaches were used to collect data. A descriptive type of study was used in order to find out the status with regard to the current performance of X-ray equipment in Malawi and to give an adequate description in terms of frequencies and percentages thereof (Bailey et al., (1997:120). It was exploratory because the study investigated the availability of QA and QC measures in X-ray departments of certain government hospitals in Malawi. It was descriptive in nature as both retrospective and prospective data was collected with the aim of portraying characteristics of a situation and the frequency with which certain phenomena occur (Polit, Beck and Hungler, 2001:180). It describes the status of X-ray equipment and the availability of QA and QC measures according to results of QC measures and tests conducted and responses from Radiographers in-charge and Maintenance Officers/Hospital Administrators. A quantitative paradigm was used since the majority of the data collected was numerical and statistically analyzed. Retrospectively, records were checked by the researcher for the availability of QA committees of the hospitals as well as within the radiology departments and for any maintenance preventive measures done in the past. Prospectively, different tests were conducted on the X-ray equipment to establish their current status. 41

56 3.3 Research Methods Population The study population consisted of government hospitals that consisted of both central and district hospitals in Malawi with the exclusion of 1 hospital situated on an island. All four central hospitals from the country were selected and 10 out of 23 district hospitals were selected from the three regions of the country. These are the hospitals that have an X-ray department with a functional X-ray unit. The district hospitals were selected from all three regions of the country Sampling Method and Sample Size Firstly, using a non-probability census type of sampling method, all four central hospitals in the country were involved in the study. These are the hospitals where there is more than one X-ray unit in each hospital and that treat more patients than district hospitals. Then a probability sampling using stratified sampling method was used for selecting the district hospitals. Hospitals were grouped according to their locations in the three regions of the country. From each of the groups from the three regions, hospitals were selected using a systematic sampling method. In total 4 central hospitals and 10 district hospitals were selected from across the country. Accumulatively, 52% of all 27 central and district hospitals run by the government were covered. Two other district hospitals were used for pretesting of questionnaires and QA tests. These two hospitals used for pretesting of data collection methods were consequently excluded from the study. The following is the breakdown of hospitals that were involved in the study: Central hospitals 4 District hospitals 10 District hospitals for pretesting 2 Total 16 42

57 3.4 Measuring Tools Two questionnaires using a literature review and the researcher s experience were developed to find out the availability of QA programme in the hospitals (Health Canada, 1996:1-16). QA tests were done on X-ray equipment to check their current performance using locally available tools as recommended by WHO standards (Lloyd, 2001:30, 33, 58 and 79). Formulation of questionnaires and conduction of QA tests were done according to methods followed by other countries after an extensive literature review Questionnaires Two different questionnaires, after having done a pilot study, were distributed to the targeted population. One questionnaire was for the Radiographer in- Charge and the other was for the Maintenance Officer/Hospital Administrator (see Appendices 3 and 4 respectively). The questionnaire for the Radiographer in-charge was divided into several categories. Most questions were closed-ended with a few open-ended questions. All questions were asked with the aim of getting answers according to the aim and objectives of the study Questionnaires for the Radiographer In-Charge (Appendix 3) The first question was to find out if there was a QA committee in place for the X-ray department that takes responsibility for the implementation of QA measures and tests. A QA committee is essential for a QA programme to be successfully implemented. As stated by Stevens, (2001:6-7), a QA committee for the imaging department ensures the establishment of proper criteria for performing QC tests and takes the responsibility of ensuring the implementation of the criteria. The committee ensures that each test is conducted according to correct standards and done according to the required time schedule. This is also important for ensuring that normal services are not interrupted due to lack of staff or time. 43

58 Questions 2 to 9 were formulated for the Radiographer in-charge where a QA committee was available. These questions focussed on the availability of a QA programme and how it is implemented. Information was sought on the person responsible for QC measures and tests and if a QA programme manual was available for documentation of all activities done in relation to the QA programme. A QA responsible person makes sure that QA measures and tests are done and to the required methods and standards. According to Stevens (2001:2) it is essential to appoint a responsible person to effectively oversee the running of the QA programme. He/she also makes sure all QA proceedings are recorded in a QA manual book for proper monitoring of equipment performance and future reference. This may help technicians and engineers to effectively diagnose a problem when the equipment breaks down. Questions 10 to 15 were for those departments that had no QA committee for the department but some QC tests were being conducted. The aim was to find out what QC tests were being conducted on the equipment even though they have no QA committee. Even without a QA committee, radiographers are expected to have a basic knowledge of QC tests and are supposed to ensure that performance of the equipment is regularly checked to avoid break-downs. The questions involved finding out about the type of QC tests done, responsible person coordinating the conduction of the tests, availability of test films and to whom the results of the tests are reported. Whenever QA tests are done, examples of test films should be kept for future reference and comparison with new results when subsequent tests are done on the same equipment. In this way monitoring of equipment performance is effective and any parts that are wearing out can be detected and replaced. The responsible person coordinating the QC measures and tests ensures that records of these test results are well kept. Finally, questions 16 to 19 were to be answered by the Radiographers in- Charge of both X-ray departments that had a QA committee and those that 44

59 did not. Focus was on whether the X-ray equipment was being serviced or not, who does the servicing of the equipment if any and the availability of records of the services done. Any X-ray equipment that has been installed should undergo acceptance testing first before being used and regular servicing is also important to ensure that the equipment does not break down due to faulty parts that were not replaced due to wear and tear. Servicing of equipment can be done by the manufacturers or locally based engineers who are trained in such equipment depending on the agreement between the suppliers and the users of the X-ray equipment Questionnaires for Maintenance Officers/Hospital Administrators (Appendix 4) Questionnaires for the Maintenance Officers/Hospital Administrators had four closed-ended questions focussing on the existence of QA measures. The first question was to find out if a QA committee for the hospital was available. The availability of a hospital QA committee is essential so that the hospital management can include it in its plans and budget the activities related to QA of the whole hospital. QA programme requires adequate financial support for it to run efficiently. Without the support of the hospital management it can be difficult to run the programme. Question 2 was to find out if the hospital has a documented QA programme for the departments and if they had a copy available for the researcher to see. A QA programme is effectively run if there is follow-up and monitoring of activities for the programme. Monitoring of the programme can only be effectively done if there are documented files for the QA programme. Results of tests are compared with previous test results to check if there is consistency in performance of the equipment or not. This is when corrective action can be taken if the equipment is found not to be performing to the required standard. Records also give information to the management on which departments of the hospital are doing well in providing quality services. 45

60 Question 3 was to be answered by a Maintenance Officer/Hospital Administrator at the hospitals where there was a documented QA programme being run. The aim of the question was to find out who was responsible for ensuring that the QA programme was running and operating efficiently. The responsible person should ensure that he/she receives results from different departments of the hospital and reports to the top management on any action to be taken. Without a responsible person for the QA programme there is no way of monitoring if the programme is running well or not. The last question was for those hospitals that had no QA committee. The purpose was to find out if having such a committee was important. They were also asked to give reasons for the answer given. This was asked with the aim of finding out how important the Maintenance Officers/Hospital Administrators regarded the requirement of a QA committee and a QA programme as a whole Quality Control Tests The tests were conducted using simple methods with locally available materials. All tests were done according to prescribed methods and materials as advocated by the World Health Organization (WHO) to ensure that international standards were met. The use of simple methods and materials may demonstrate to radiographers that QA and QC programmes can be conducted in the hospitals in a cost effective way using locally available materials. As stated by Lloyd (2001:1), a QA programme should be cost effective while achieving its goals. The tests conducted are described in to Beam Alignment and Collimation Test The beam alignment and collimation test was done in 12 out of 14 hospitals where there was electricity power available at the time of the study. Only in 2 hospitals was there no electricity power and no tests were done. The 12 hospitals included all four central hospitals and 8 district hospitals. 46

61 This test was done with the aim of finding out if the light beam field projected by the tube is in alignment with the X-ray beam when an exposure is made. Any misalignment of the light field and the X-ray beam may result in a wrong field size of the body part being X-rayed. This invariably leads to repeat X-ray examinations resulting in unnecessary radiation exposure to the patient. The test was also done to check if the centring point of the light field coincides with the midpoint of the X-ray beam. When the X-ray beam is not centred to the area under investigation one may get geometrical unsharpness of the area concerned. The procedure for the test involved placing a cassette loaded with an X-ray film on the X-ray table under the tube. The light beam field was then directed on to the cassette covering the size of the cassette but leaving an edge of about 2 cm around. Paper clips were placed on the cassette to mark the borders and the centring point of the light field. Two exposures were then made, one with a bigger field and another with a smaller field. After the exposures, the X-ray film was processed in the darkroom and later evaluated. (See Appendix 5 for detailed procedure.) Constancy of Radiation Output at Different ma and Time Settings Test This test was conducted in 6 out of 12 hospitals where there was electricity power available. The 6 hospitals included 2 central hospitals and 4 district hospitals. In the other 6 hospitals it could not be done because there was no provision for selecting ma and time separately on the X-ray equipment. The X-ray equipment had a combined mas control. It is acknowledged that there are specific test tools that are used to test equipment with combined mas, however, this was not done as only locally available tools as described by (Lloyd, 2001:58) were used for the reasons outlined in chapter 1. This test was done with the aim of finding out if there is consistency of the X- ray tube in producing uniform density at different combinations of ma and seconds but using the same mas setting. Three exposures were done on the 47

62 equipment using the same kv and mas but different combinations of ma and seconds for each on a single cassette in three strips. A step wedge was placed on the cassette for each exposure. (See Appendix 6 for detailed procedure.) Any difference in density when different combinations of ma and seconds are used for the same mas may result in loss of quality of radiographs which leads to repeat X-ray examinations. Repeats lead to more radiation exposure to patients and staff and increases wear and tear of equipment and this becomes more costly for the department Screen-Film Contact Test This test was performed in 11 hospitals out of 14. In two hospitals there was no electricity during the time of the study. In one hospital the electric power went off while the researcher was in the process of conducting the QC tests. A power transformer for the area had just blown. The commonly used cassettes in the department were selected for the test. Two types of cassettes, 24 x 30cm and 35 x 35cm size were used in each hospital. This test was performed with the aim of investigating if there was good filmscreen contact within the cassettes and if there was presence of artefacts on the screens. The most used cassettes in the X-ray departments were selected for the test. Good screen-film contact is essential for the production of quality radiographs. Any loss of contact results in poor transmission of light from the screens to the film which leads to undeveloped areas of the processed radiograph. The procedure for the test involved placing a cassette on the X-ray table under the tube. Paper clips were spread evenly on top of a loaded cassette and an exposure made. The film was then processed in the darkroom and evaluated (see appendix 7 for detailed procedure). 48

63 Safe Light Efficiency Test Processing of exposed X-ray films is done in the darkroom where safe lights are used during processing. Safe light efficiency tests were done to check how efficient the safe lights were at providing illumination in the darkroom. As X-ray films are sensitive to light, an increase in the safe light wattage or number of bulbs beyond the required limit in the darkroom may cause fogging of films. The fogging of films may lead to the production of poor quality radiographs resulting in repeats. A safelight efficiency test was conducted in 9 out of 14 hospitals that the researcher visited. As explained earlier, there was no electricity power available in 2 hospitals. In one other hospital the power went off during the course of conducting the tests due to a blown transformer for the area. In another 2 hospitals the test could not be done because the safelights were not being used because of lack of bulbs and filters. X-ray films were being processed in complete darkness. Procedures for the test involved placing a loaded test cassette on the X-ray table and exposing it to radiation. One third of the cassette was covered with lead rubber during this radiation exposure. Then the film was exposed to safelights in the darkroom with one third of the cassette covered with cardboard on the side exposed to radiation. The processed film was then evaluated for the presence of fogging in areas covered with cardboard. (See Appendix 8 for detailed procedure.) White Light Leakage Test A white light leakage test was done in the 12 hospitals where there was electricity power available. This test was performed with the aim of finding out if there were any places inside the darkroom where there was white light leakage from the outside. During processing of X-ray films white light must be eliminated. Doors, ceilings and places where pipes enter the darkroom or the 49

64 air conditioning machine was installed were checked for possible light leakage. All lights in the darkroom were switched off and researcher remained in complete darkness for a minimum of 10 minutes. During this time the researcher checked for any leakage of light from outside the darkroom taking note of the time the leakage was seen from the time the lights were switched off. (See Appendix 9 for details of procedure.) 3.5 Validity of Measuring Tools The validity of the measuring tools was tested during a pilot study at two hospitals before collection of data started. Questionnaires were checked for understanding of the questions by participants. The researcher also checked if the participants answered the questions according to the researcher s expectations. During testing, questions were discussed with the respondents to check if they made sense. Corrections were made where necessary but there were very minor adjustments since most questions were answered according to the researcher s expectations. Both questionnaires for the Radiographer in-charge and Maintenance Officer/Hospital Administrator were tested. The QC tests that were used (Appendices 5 9) are internationally accepted standards developed by the WHO and have no copyright restrictions to ensure reliability. Pre-testing of the testing tools was done at two hospitals together with a co-supervisor based in Malawi to further assess their reliability before the actual data collection started. The pretesting of the QC tests was successful as expected results were obtained. 3.6 Ethical Considerations Research can uncover or shed light on undesirable situations of an institution or department (Partington, 2002:20). In ensuring that ethical considerations have been met, consent to conduct the study was sought from the Ministry of 50

65 Health (Appendix 1) and permission was granted (Appendix 2). Heads of X- ray departments at central and district hospitals were also informed. Names of heads of departments who were involved in providing records for the study were kept anonymous and the participants were informed that the study was being conducted with the aim of improving the quality of X-ray equipment services. The QC tests done on the X-ray equipment did not involve patient participation. Emphasis for the reason of doing the research was to have a better insight into equipment performance. Approval from the University of Johannesburg Ethical Clearance Committee was also given (Clearance number 43/08). 3.7 Data Collection Procedure The data collection exercise was done by the researcher between August and September The researcher went to each and every hospital targeted for the study. First the researcher together with a co-supervisor conducted pretesting of the data collection methods at two hospitals, one in the central region and one in the northern region. Minor changes to the questions on questionnaires were made in consultation with the supervisor through before starting the actual data collection. Since the hospitals are spread throughout the three regions of the country, they were divided into three groups for the data collection exercise. First, data was collected in the northern region, then the central region hospitals and finally, data was collected in the southern region hospitals. Three hospitals were visited in the northern region in the first two weeks. Then five hospitals in the central region were visited for the study over three weeks. Finally data was collected in five hospitals from the southern region of the country over another three weeks. The data collection process took eight weeks. The sample data consisted of the following: 51

66 Information on records available on QA and QC measures and tests Information on preventive maintenance measures of X-ray equipment Results of quality assurance tests conducted on the X-ray equipment in hospitals that have X-ray equipment. These were sampled from the three regions of the country. All the X-ray departments have darkrooms and X-ray accessories, for example cassettes. At each hospital the researcher first reported to the Radiographer in-charge of the X-ray department to give him/her the questionnaire. Then together with Radiographer in-charge went to see the Maintenance Officer to hand the questionnaire to the Maintenance Officer/Hospital Administrator. If the Maintenance Officer was not available the questionnaire was given to the Hospital Administrator or the Medical Director for the hospital. After explaining the purpose of the study to the Maintenance Officer, the questionnaire was left with him/her to be collected later after conducting the QC tests in the X-ray department. Where none of the officers were available, the questionnaire was left with the secretary or the Radiographer in-charge to be given to him/her later, and they were requested to send the completed questionnaire to the researcher by post. Having handed in the questionnaires to the necessary people, QC tests were then conducted in the X-ray department. The tests were conducted when there were no patients to be examined. When the tests could not be finished on the same day, the conducting of tests continued the following day. A maximum of two days was planned to be spent at each hospital to provide time for travelling from one district to another. There was limited time planned for the data collection to ensure every targeted hospital was visited since there were limited funds as the researcher was self-sponsored. 52

67 After giving questionnaires to the Radiographer in-charge and Maintenance Officer/Hospital Administrator, QC tests were then conducted at the X-ray department. Tests included light beam alignment and collimation, screen-film contact, constancy of radiation output at different ma and time settings and darkroom light efficiency. Completed questionnaires were collected upon completion of all tests. All tests were conducted according to standard protocols as set out in Appendices 5 to 9. Table 3.1 shows a framework for the data collection exercise according to location of the hospitals. In total there were 14 targeted hospitals; 6 in the southern region, 5 in the centre and 3 in the northern region. The two hospitals that were used for pre-testing of the questionnaires and QA tests were excluded from the study. 53

68 Table 3.1 Data Collection Exercise Regions Hospitals (Coded 1 to Week Week Week Week Week Week Week Week 14) Northern 1 Central 4 and 5 6 and 2 8 Southern Pretesting 7 and 9 10 and and and 3 Two other hospitals

69 3.8 Data Analysis Data was analyzed both manually as well as using a computer. Computer aided analysis was done using statistical techniques to help in describing variables and their effects and relationships on the status of X-ray equipment (Welman & Kruger, 2001:194). Cross tabulations were statistically done between responses to the availability of QC tests from Radiographers in-charge and results of actual tests conducted by the researcher. Statistical analysis is important as it helps in organising, evaluating and interpreting numerical data (Polit and Beck, 2004:451). With the help of a statistician SPSS 15 was used to analyze the data. 3.9 Study limitations It was not possible to cover all the hospitals that have X-ray equipment in Malawi because some districts are difficult to reach. In some areas there is poor road infrastructure and one of the hospitals is on an island where there is lack of a regular transport system between the main land and the island, thus these were excluded from the study. Another limitation was that in two of the 14 targeted hospitals there was no electricity the days the researcher went to collect data. It was not known when the power would be back because sometimes it can take up to three days or more to restore power. In these situations only the questionnaires were completed and no tests were done on the X-ray equipment. This is documented under each test. In two hospitals the Hospital Administrator and the Maintenance Officers were out of the districts. Even though the questionnaires were left for them to complete, they were not sent back to the researcher as arranged with the Radiographer in-charge. This means tests were performed at 12 (86%) of the 14 targeted hospitals and 26 (93%) of the 28 questionnaires were completed and collected by the researcher. Fortunately these shortcomings should not affect the outcome of the study as the failure rate was very small. In total 52% of all 55

70 government hospitals that have X-ray departments in Malawi were included in the study Conclusion Data was collected for the study using two types of questionnaires, one for the Radiographer in-charge and another for the Maintenance Officer/Hospital Administrator. QA tests were conducted on X-ray equipment at each hospital. Questionnaires were self formulated and included open ended and closed questions. The questionnaires were formulated with the aim of finding out the availability of QA committees and QA programmes at the hospitals and the X-ray departments. QA tests were conducted on X-ray equipment to check their current performance. Tests included light beam alignment and collimation; constancy of radiation output at different ma and time settings; screen-film contact; safe light efficiency and white light leakage tests. Validity of the measuring tools was tested at two hospitals to ensure clarity of questions and that the expected answers were obtained. The pretesting was done together with supervision of the co-supervisor at both hospitals. The pilot study also helped the researcher to familiarize himself with the test procedures before embarking on actual tests. International standards using WHO guidelines were used in conducting the QA tests to ensure reliability of the test procedures. Out of 14 hospitals, QA tests were conducted in 12 (86%) hospitals. All 14 (100%) questionnaires for the Radiographer in-charge were answered and returned to the researcher. Out of 14 questionnaires for the Maintenance Officer/Hospital Administrator, 12 (86%) questionnaires were completed and returned to the researcher. Results of findings from the data collected will be presented in the next chapter. 56

71 CHAPTER FOUR RESULTS 4.1 Introduction In this chapter the analysis of results of the study will be presented. Data was collected using questionnaires that were given to the Radiographers in-charge of X-ray departments and Maintenance Officers/Hospital Administrators at the targeted hospitals. QA tests were also done on the X-ray equipment. Collection of data was done for eight weeks from August to October Questionnaires were used to find out the availability of QA programmes in the respective hospitals while QA tests were done to find out the current state of performance of X-ray equipment in the hospitals. There were two types of questionnaires; one questionnaire was for Radiographers in-charge and another was given to Maintenance Officers or Hospital Administrators to complete. Five QA tests were performed for the equipment at each hospital where possible. The tests were as follows: Beam Alignment and Collimation Constancy of radiation output at different ma and time settings Screen-film contact Safelight efficiency Light leakage 4.2 Characteristics of Study Population The sample population composed of 14 hospitals from across the country. The following tables show categories of the study population according to different data collection techniques. 57

72 Table 4.1 Breakdown of Study Population according to Questionnaires n=14 Category Total Number Number of Responses (coded) Percentage of Responses Radiographers In % Charge (1 14) Maintenance Officers/Hospital Administrators (1, 2, 3, 5, 6, 7, 8, 9, 10, 11, 12, 14) 85.71% According to the table above the researcher received completed questionnaires from all the Radiographers in-charge, coded 1-14, that were targeted. Out of 14 questionnaires for the Maintenance Officers/Hospital Administrators, 12 (85.71%) questionnaires were returned to the researcher. The Maintenance Officers and the Hospital Administrators were not available at 2 hospitals. The questionnaires were left for them to fill later but unfortunately were not sent back to the researcher. Table 4.2 shows the breakdown of the study population according to QC tests done. In two hospitals there was no electricity, so tests could not be done. Table 4.2 Breakdown of Study Population according to QA Tests n=14 QA Tests Total No Targeted Number of Tests Conducted (coded) Percentage of Tests Beam Alignment % and Collimation (1,3,4,6,7,8,9,10,11,12,13,14) Constancy of % Radiation Output (1,6,7,8,11,13) Screen-Film Contact (1,3,4,6,7,8,9,10,11,13,14) 78.57% Safelight Efficiency 14 9 (1,3,4,7,8,9,10,11,14) 64.28% White Light Leakage 14 12(1,3,4,6,7,8,9,10,11,12,13,14) 85.71% 58

73 According to Table 4.2, beam alignment and collimation tests were conducted in all 12 hospitals where there was electricity available. From 12 hospitals where there was electricity power available, the screen-film contact test was conducted in 11 hospitals because in one hospital the electric power went off due to a blown transformer during the course of performing the QC tests. The constancy of radiation output tests were done in 6 (42.85%) hospitals only because in the other hospitals the equipment had no option of selecting ma and time separately for the test to be done. Safelight efficiency tests were performed in 11 out of the 12 hospitals because in one hospital the electric power went off while performing the tests. White light leakage tests were performed in all 12 hospitals. 4.3 Results from Questionnaires from the Radiographers in-charge (Appendix 3) The following outlines the results collected from the questionnaires filled in by Radiographers in-charge from all 14 hospitals. Results are presented according to questions from the questionnaire. Question 1. Does the X-ray Department have a QA committee? The aim of question 1 was to find out if the X-ray departments had a QA committee that was responsible for running QA programmes. Results from 14 hospitals show that in all 14 (100%) hospitals there was no QA committee in the X-ray department. Questions 2 to 9 were for Radiographers in-charge where there was a QA committee in place in the department. Since all 14 X-ray departments had no QA committee the analysis of these questions is not required. 59

74 Question 10. If there is no QAC for the department, are there any QC measures or tests performed on the equipment? Question 10 was designed to find out if any QC measures or tests were being conducted in the X-ray departments even if they had no QA committee in place. The aim was to find out if any QA tests were performed to check equipment performance. Table 4.3 shows results of the answers provided on whether QC tests were being conducted or not in the departments. Table 4.3 Availability of QC Measures and Tests (n=14) Hospitals Results (Coded 1-14) Yes No Total 9(64.29%) 5(35.71%) Total 100% 60

75 Number of Hospitals According to Table 4.3 above only 9 (64.29%) of the 14 hospitals said some QC tests were conducted in the department. Five X-ray departments said there were no QC tests done at all. Question 11. State which tests or QC measures are done Respondents were given options to choose from a list of tests and to mention additional ones that they conduct if any. From the 9 hospitals that indicated they conduct some QC tests, the following tests as in Figure 4.1 were identified: Beam alignment and collimation Constancy of Radiation Output at Different mas 6 Darkroom Lighting Effeciency 5 4 Screen-Film Contact Reject Analysis Radiation Leakage Quality Control Tests Figure 4.1 Examples of QC Tests Done in Hospitals From the results shown in Figure 4.1 all 9 (100%) Radiographers from the hospitals said they conduct a beam alignment and collimation and screen-film contact tests. Constancy of radiation output tests are done in 3 (33.33%) of the hospitals. Darkroom lighting efficiency tests are conducted in 7 (77.77%) 61

76 hospitals, radiation leakage tests are done in 2 and reject analysis performed at 1 hospital only. None of the X-ray departments made mention of any other tests. Question 12. Who is responsible for ensuring that the QC measures or tests are being done correctly? Question 12 was to find out who was responsible for ensuring that QC measures and tests were being conducted and correctly. Options were provided for the respondents to choose from. All the 9 (100%) hospitals said that the head of the X-ray department was responsible for QC measures and tests. Question 13. Does the department have examples of test films that are done? This question was asked with the aim of proving if tests were really being conducted. Of the 9 respondents that said they conduct some tests, only 1 hospital had examples of test films that were used for QC testing. Question 14. To whom are the results of the tests reported? Question 14 was designed to find out to whom the results of the mentioned QC tests are reported in order to find out if there is someone who takes responsibility for the results and takes appropriate action. Options were given to choose from according to known authorities. Figure 4.2 below shows the results of the answers given. 62

77 11% 11% 45% Electro-Medical Engineer Head of Department QA Responsible officer Don't Know 33% Figure 4.2 Results of Tests Reported To According to results in Figure 4.2 above, 4 (45%) respondents said the reports were sent to the electro-medical engineer, 3 (33%) respondents said the reports are kept by the head of X-ray department, 1 (11%) respondent said he/she sent them to the District Health Officer and 1 (11%) said he/she does not know to whom the results should be sent. Question 15. What benefits have been obtained by implementing such QC measures as stipulated in question 11? Question 15 was asked with the aim of finding out what benefits are obtained by performing QC tests that were mentioned in Question 11. Figure 4.3 shows the benefits mentioned by the 9 hospital respondents who said they conduct some QC tests. 63

78 Number of Hospitals Radiation Protection Less frequent breakdowns Better quality of radiographs Less down time Figure 4.3: Benefits of QA Tests According to the results in Figure 4.3 above, 3 (33.33%) respondents mentioned fewer breakdowns of X-ray equipment as one of the benefits, 8 (88.88%) mentioned better quality radiographs, 1 (11.11%) mentioned having less down time of X-ray equipment and 2 (22.22%) mentioned better radiation protection as one of the benefits. Questions 16 to 19 were for Radiographers in-charge of X-ray departments regardless of whether they had QC measures and tests in place or not. Question 16. Is the X-ray equipment ever serviced? Question 16 was to find out if the X-ray equipment was ever serviced. The aim was to find out if there are regular planned services done on the equipment to check its performance. Out of 14 hospitals, only 5 (36%) Radiographers in- 64

79 Number of Hospitals Charge said it was serviced and 9 (64%) said no service is ever done on the equipment. Question 17. If the answer to question 16 is yes, how often is the equipment serviced? Question 17 was directed to the hospitals whose equipment was being serviced and to find out how many times the servicing was done. Options were provided by the researcher for the respondents to choose from and add any other period of servicing. Figure 4.4 shows the results of question 17 indicating how often equipment is being serviced in the 5 hospitals Annually 2-3 years Corrective Maintenance Figure 4.4: Frequency of Equipment Services According to results from Figure 4.4, in 1 hospital the equipment is serviced annually and in 1 other hospital it is serviced within 2 to 3 years. In other 3 65

80 hospitals the service on the equipment was only done as a corrective service (repair) when the equipment broke down. Question 18. Who does the servicing of the equipment? Question 18 asked who does the servicing of equipment with the aim of identifying if there are any experts specifically assigned for servicing X-ray equipment in government hospitals. Options were provided to choose from. Figure 4.5 shows results of responses provided. 17% Electro-Medical engineers 17% Engineers from Equipment manufacturers 66% Manufacturers and Electro- Medical Figure 4.5 Personnel Who Service Equipment According to responses in Figure 4.5, out of 5 hospitals, 3 respondents indicated it was serviced by the Electro-Medical Engineers, 1 indicated that the equipment was serviced by the manufacturers and 1 mentioned both the manufacturers and the Electro-Medical Engineers. 66

81 Question 19. Does the department have records of the past services done on the equipment? Question 19 was designed to establish if records of past services were available for the researcher to see. Only 3 (60%) out of 5 hospitals had records of past services available. Records seen by the researcher were mainly those made through an agreement between the manufacturers and the X-ray department in collaboration with the electro-medical engineering section. These concerned new machines which the manufacturers had installed within the past two years in all 3 hospitals. 4.4 Results from Questionnaires from Maintenance Officers (Appendix 4) The following gives an outline of results according to responses from Maintenance Officers/Hospital Administrators. According to results on Table 4.1 on page 55, there were 12 (86%) responses out of 14 hospitals. Question 1. Does the hospital have a QA committee? This question was asked with the aim of finding out if the hospital has a committee that is responsible for and looks into the activities related to quality management in all the departments of the hospital. Table 4.4 shows results on the availability of QA committees in the hospitals. 67

82 Table 4.4 Availability of Hospital QA committees (n=12) Hospitals Results (coded 1-14) Yes No Total 1(8.3%) 11(91.7%) Total 100% According to the table above there is only 1 hospital out of 12 that has a QA committee. The one hospital where there is a QA committee it caters for all departments of the hospital with the Hospital Administrator being responsible for all activities pertaining to QA. Question 2. Does the hospital have a documented QA programme? A properly run programme is easily monitored if activities of the programme are documented. This question was asked to find out if the hospitals that have a QA programme have records of measures and tests conducted. Out of 12 hospitals only 2 have a documented QA programme. Though respondents from two 68

83 hospitals mentioned they have a documented QA programme, only one hospital had records of the QA programme available that the researcher was able to see. This is the hospital that has a QA committee in place (see Table 4.4 on page 68). Question 3. Who is responsible for QC measures and tests for equipment in different departments of the hospital? Question 3 was for the Maintenance Officer or Administrator where there is a QA programme in place. From the two hospitals that have a documented QA programme, the Hospital Administrator is responsible for QC measures and tests. Question 4. If there is no QA committee, do you feel it is important to have one? This question was mainly to find out the feelings they have about the importance of having a QA committee. All 12 (100%) respondents said it is important to have a QA committee. The respondents were further asked to give reasons for having one or not having one. Figure 4.6 shows the answers given according to each hospital. 69

84 6 5 5 Improve life-span of and quality of equipment Planning of work Continuity of services Number of Hospitals Hospitals Cost effective services Sustainable productivity Radiation control Transparency on quality of maintenance Safety of people Monitoring of equipment performance Collaboration with engineers 0 Reasons Figure 4.6 Reasons for having a QA Committee According to results in Figure 4.6, there were 10 reasons that were given for the importance of having a QA committee. Each reason has been categorized according to the number of hospital respondents that mentioned it. Improvement of quality and life-span of equipment was indicated in 5 hospitals, planning of work by 2, continuity of services by 1 and cost effective services by 2. Sustainable productivity was stated by 1 respondent, radiation control by 1, safety of people by 2 and transparency on quality of maintenance was mentioned by 2 respondents. Monitoring of equipment was mentioned by 1 and collaboration with engineers by 1 respondent. 70

85 4.5 Results from Test Procedures Each test was done separately yielding independent results and different test tools were used for each test. As shown in Table 4.2 on page 58 there were five QC tests conducted during the study. Data was analysed using graphs and tables with assistance from a statistician. The results of these are reported below Beam Alignment and Collimation Test A beam alignment and collimation test was done in 12 hospitals. This test could not be done in 2 hospitals because there was no electricity during the time of the study. The main purpose of this test was to find out if there was any misalignment between the light beam and the X-ray beam from the tube. The light beam shows a radiographer where the X-ray beam is focussed since the light beam field is made in such a way that it is congruent to the field of the X-ray beam. The two beam fields should be aligned and focussed on the same area to ensure that collimation of the X-ray beam is perfect and correct at all times. With a long time of use of the X-ray tube, there is sometimes a loss of original congruency. This can be caused by a change in position of the reflective mirror, X-ray anode focal spot, the light bulb filament or the collimators (Siedband et al., 1981:18). Figure 4.7 shows an example of a misaligned light field with the X-ray beam after performing a test at one of the hospitals. 71

86 A B C D Figure 4.7: An Example of Test Film with Misaligned Beam Collimation In Figure 4.7 the margins of the light field marked by staple wires are outside the border of the exposed area on sides AB, CD and BD but on side AC, the radiation exposed area is outside the area shown by the light field. This result is shown on both the small and the large collimation. The mid-point of the light field is also off centred to the X-ray beam. The following tools were used for the test in each hospital: One 24 x 30cm cassette loaded with X-ray film 72

87 Eight paper clips Lead marker The procedure used is as explained in Appendix 5 according to the WHO protocol. After doing the test in 12 hospitals, Figure 4.8 reflects the results Number of Hospitals 10 8 Hospitals 6 No 12 Yes 4 Yes 6 No 6 No 2 0 Yes 0 Correct Alignment Centred Midpoint Figure 4.8 Beam alignment and Collimation Test According to results in Figure 4.8 in all 12 (100%) hospitals the beam alignment was misaligned. In checking the centring point of the X-ray beam in relation to the light field area exposed, in 6 (50%) hospitals the X-ray beam was not centred to the mid-point as shown by the light field but was correctly centred in the other 6 (50%) hospitals. 73

88 4.5.2 Constancy of Radiation Output at Different ma and Time Settings It is important for the radiation output to be the same for different settings of ma and seconds for the same mas. For example; 10mAs from a setting of 100mA x 0.1 second and 10mAs from a setting of 50mA x 0.2 second should ideally produce the same density on the X-ray film. After using the equipment for a long time, this may not be the case. As such, a test was done with the aim of checking if the equipment is constant in producing X-radiation at different mas settings (Lloyd, 2001:58). The following tools were used for the test in each hospital where the equipment had provision for calibrating ma and seconds separately: A step wedge Two sheets of lead rubber One 24 x 30cm cassette The procedure used is as explained in Appendix 6 according to the WHO protocol. This test was conducted in 6 hospitals only because in the other 6 hospitals there was no option of choosing ma and time in seconds separately. From the 6 hospitals where the test was conducted Figure 4.9 shows the results of the tests. 74

89 Number of Hospitals Yes No difference in density No Figure 4.9 Constancy of Radiation Output Test Figure 4.9 shows results of the constancy of radiation output at different combinations of ma and time. As depicted in Figure 4.9 in 4 (67%) hospitals there was consistency in producing the same density using the same mas but different combinations of ma and seconds for three exposures made at each hospital. In the other 2 (33%) hospitals there were differences in density for the three exposures in the resultant films. Figures 4.10A and 4.10B below show examples of test films, one with differences in density and another with equal densities from two of the hospitals. 75

90 A B C Figure 4.10A: A Test film showing differences in Density As shown from the test film in Figure 4.10A, strips A, B and C on the film show different densities even though the same kv and mas were used for all three exposures but using different combinations of ma and time. The middle strip, B, is much lighter than strips A and C. A B C Figure 4.10B: Test Film showing equal densities on three strips 76

91 In Figure 4.10B the results show that all the three strips A, B and C on the X-ray film from one of the 4 hospitals are almost equal in their densities as compared to the one in Figure 4.10A Screen-Film Contact Test Contact between the film and intensifying screens in an X-ray cassette is very important for the production of quality images. Where the contact is not adequate a different density is produced compared to other areas of the same film. This may give a false interpretation of the radiograph. The main aim of the test was to find out if frequently used cassettes in the X-ray department were producing a uniform density on films. In addition to finding uniform contact between the screens and films, presence of artefacts was also checked using the same test. The test results presented are from 9 hospitals out of the 14 hospitals. This was because in two hospitals there was no electricity for days and no QA tests were performed. In one other hospital the electricity went off while in the process of conducting QC tests and the screen-film test was not done. The power transformer for the area had blown. In the other two hospitals the test was performed but accurate results could not be obtained for uniform contact because there was X-ray beam cut-off. Thus of the original 14 hospitals targeted for the screen-film contact test only 9 results could be considered for analysis. The results for the visual assessment of artefacts were however obtained from all the 11 hospitals where the test was conducted. Two types of cassettes were tested during the study, 24x30cm and 35x35cm cassettes, as these were the most frequently used cassettes. The following tools were used for the test in each hospital: Cassette to be tested loaded with a film 77

92 Number of Hospitals A box of paper clips enough to cover a 35 x 43cm film Lead marker if cassettes did not have a lead blackened area for patient details The procedure used is as explained in Appendix 7 according to the WHO protocol. Figure 4.11 shows the results of the screen film contact tests conducted in 9 hospitals Poor contact Good contact 0 24x30cm Cassette Sizes 35x35cm Figure 4.11 Screen-Film Contact Test Out of 9 hospitals results show that there was a good screen-film contact for cassettes in 8 (89%) hospitals for both 24x30 cm and 35x35 cm cassettes compared to only 1 (11%) which had poor contact for both sizes of cassettes. Most of the cassettes however were not more than two years old. Figures 4.12A and 4.12B below are examples of test films with uniform contact and uneven contact from two of the hospitals respectively. 78

93 Figure 4.12 A: An Example of Test Film showing uniform contact between Screens and X-ray Film Area showing poor film/screen contact Figure 4.12 B: An Example of Test Film with Uneven Contact between Screens and X-ray Film 79

94 As shown in Figure 4.12 A all the staple pins are sharp as compared to those in Figure 4.12 B in which some staple pins are sharp and some are not, especially in one corner of the film, showing uneven contact between screens and X-ray film. The results for presence of artefacts are presented in Figure 4.13 below Number of Hospitals Hospitals No artefacts Artefacts present 0 24x30cm Cassette Sizes 35x35cm Figure 4.13 Presence of Artefacts According to Figure 4.13 above, in 5 (45%) hospitals out of 11, cassettes had no artefacts present on 24x30 cm cassettes compared to 6 (55%) that showed the presence of artefacts on 24x 30 cm cassettes. For the 35x35 cm cassettes 7 (64%) presented with no artefacts compared to 4 (36%) which did. Figure 4.14 shows an example of a test film with artefacts present. 80

95 Presence of Artefacts Figure 4.14: An Example of a Test Film with Artefacts present Presence of artefacts is shown in Figure 4.14 above in one of the test films from the hospitals Safelight Efficiency Test The intensity and colour from safelights should not be too bright, as this may lead to fogging of X-ray films in the darkroom. This test was done with the aim of finding out if the safelights in the darkroom were fogging X-ray films or not. The following tools were used for the test in each hospital: One 24 x 30cm cassette loaded with a new film Two sheets of 24 x 30cm card One timing clock One 24 x 30cm sheet of lead rubber 81

96 The procedure used is as explained in Appendix 8 according to the WHO protocol. After conducting the test in all 9 (100%) hospitals safe light fogging of films started within 30 seconds indicating that X-ray films are fogged during processing within a period of 30 seconds. Figure 4.15 below is an example of a test film showing fogging of X-ray film from one of the hospitals. A B C Figure 4.15: An Example of Fogged Test Film from Safe lights Areas A and B were exposed to low radiation but area A was not exposed to safe lights. Area C was not exposed to radiation but Areas B and C were exposed to safelights. As shown, areas B and C show high level of fogging as compared to A where there is no fogging at all after processing the film. Fogging started within half a minute of exposure to safe lights White Light Leakage Test A darkroom for an X-ray department is made is such a way that no white light, either from outside sunlight or lights from another room should enter the 82

97 Number of Hospitals darkroom during film processing. The aim of this test was to see if there were any areas within the darkroom white light leaked into the darkroom. Tools used for the test in each hospital were: Insulation tape to temporarily cover holes Chalk to mark holes The procedure used is as explained in Appendix 9 according to the WHO protocol. Figure 4.16 shows results of the test from 12 hospitals No Leakage Within 2-5min Within 5-10min Leakage Start Time Figure 4.16: White Light Leakage Test The test results in Figure 4.16 show that there was no white light leakage in only 2 (17%) out of 12 hospitals. In 8 (66%) hospitals the leakage started within 2 5 minutes and in 2 (17%) hospitals the leakage started within 5 10 minutes. 83

98 4.6 Cross Tabulations Comparison was made between the results as to the availability of QC tests that were mentioned by the hospitals in Question 11 from questionnaires for the Radiographer in-charge and the result of the actual tests done by the researcher. The following tables show results of cross tabulations that were statistically performed. It should be noted that the chi-square test results from the cross tabulations could not be analysed because the sample size was very small (Pallant, 2007:214). Table 4.5 below shows results of cross tabulation between the availability of beam alignment test in Question 11 and results of actual tests of beam alignment and collimation on correct alignment of the X-ray beam done in the hospitals. Table 4.5 Availability of Beam alignment and Collimation Test and Correct alignment of X-ray beam (n = 12) Beam Alignment Collimation Test: Correct Alignment Total Yes No Q11.1 Beam Unmarked Count alignment and (1,4,6,7) % within Q % 0% 100% collimation Marked Count (3,8,9,10, % within Q ,12,13, 100% 0% 100% 14) Total Count % within Q % 0% 100% 84

99 According to Table 4.5 there were 4 hospitals that did not mark the test as being done and 8 hospitals marked it was being conducted. Out of the 4 hospitals that did not conduct the test all 4 (100%) hospitals had a misaligned X-ray beam. Of the 8 (100%) hospitals that said they conduct the test it was shown, however, that the X-ray beam was also misaligned. In total all 12 hospitals showed misalignment of the X-ray beam to the light field. Table 4.6 below shows the results of the beam alignment and collimation test on whether the X-ray beam had a correctly centred mid-point or not. Table 4.6 Availability of Beam Alignment and Collimation Test and Centring of Midpoint of X-ray beam Results (n = 12) Beam Alignment Collimation Test Results: Centred Midpoint Total Yes No Q11.1 Beam Unmarked Count alignment and (1,4,6,7) % within Q % 75% 100% collimation Marked Count (3,8,9,10, % within Q ,12,13, 62% 38% 100% 14) Total Count % within Q % 50% 100% According to the results in Table 4.6, from the 4 hospitals that did not mark the test as being done only 1 (25%) hospital had the X-ray beam with a correctly 85

100 centred mid point and 3 (75%) hospitals did not have a centred mid point. From the 8 hospitals that marked the test as being done, 5 (62.5%) had the X-ray beam with a centred mid point and 3 (37.5%) hospitals had no centred mid point after conducting the test. In total, from all 12 hospitals, there were 6 (50%) hospitals that had an X-ray beam with a centred mid point and 6 (50%) hospitals that had no centred mid point. Cross tabulation was also done for those hospitals that said they conduct radiation output test against results of actual test of constancy of radiation output at different mas settings. Only 2 hospitals responded that they conduct this test, however the test was done at 6 sites. Table 4.7 shows results of cross tabulation between results from the questionnaire and results from the actual test on constancy of radiation output at different mas settings. 86

101 Table 4.7 Availability of Radiation Output Test and Constancy of Radiation Output Test Results ( n=6) Constancy of Radiation output Test Results: Uniform density Total Yes No Q11.2 Radiation Unmarked Count output Test (1,6,7,8) % within Q % 50.0% 100.0% Unmarked Count (11,13) % within Q % 0% 100.0% Total Count % within Q % 33.3% 100.0% The actual constancy of radiation output test was done in 6 hospitals where there was an option of choosing ma and time in seconds separately. Table 4.8 shows that from the 6 hospitals where it was possible to conduct the constancy of radiation output test, 4 (66.7%) respondents said they do not conduct the test and in 2 hospitals they said they do. Out of the four that do not conduct the test there was a difference in the output density on the X-ray film in 2 (50%) hospitals and in 2 (50%) hospitals there was no difference in the output radiation. In the other 2 hospitals that said they conduct the test, the test resulted in uniform density for both hospitals. A screen film contact test was performed in 11 hospitals because in 2 hospitals there was no electricity power during the time the researcher was there for data 87

102 collection. In 1 other hospital the electricity went off when tests were being conducted. Two types of results were obtained from the test, uniformity of contact between screens and films and presence of artefacts on the processed films. On uniformity of contact between screens and films, results were obtained from 9 hospitals out of 11. This was because results from 2 hospitals could not be correctly assessed because there was beam cut-off on one side of the film. See Figure 4.17 for an example of a test film with a beam cut-off. Areas of radiation beam cutoff Figure 4.17: An Example of Test Film with Beam Cut-off Figure 4.17 above shows areas where the X-ray beam was cut off when the film was exposed. The beam cut-off appeared on all sizes of films tested in the two hospitals so that screen film contact test result could not be analysed. Presence of artefacts was however noted on films of these two hospitals and was taken into account, therefore presence or absence of artefacts was assessed in all 11 hospitals. From the 11 hospitals where the test was conducted, all hospitals said that they perform the test according to results of Question 11 from 88

103 the questionnaire for Radiographers in-charge. Tables 4.8 and 4.9 below show results of cross-tabulation between results of availability of the test in Question 11 and the results of the actual test done on uniform contact and presence of artefacts respectively. Table 4.8 Availability of Screen-film Contact test and Uniform Contact Test Results (n = 18) Screen-Film Contact Test Results: Uniform contact Total Yes No Q11.3 Screenfilm 24 x 30cm Count Contact cassette % within Test Q % 11% 100.0% 35 x 35cm Count cassette % within Q % 11% 100.0% Total Count % within Q % 11% 100.0% According to Table 4.8 above, 18 cassettes were tested for uniformity of contact between the screens and films, 9 cassettes of 24x30 cm size and 9 of 35 x 35cm size from 9 hospitals. Results show that for each size of cassette there were 8 (89%) cassettes that had uniform contact between the screens and films compared to only in 1 hospital that had poor contact. In total there were only 2 (11%) cassettes that had no uniform contact out of

104 Table 4.9 Availability of Screen-film Contact test and Presence of Artefacts Test Results (n=22) Screen-Film Contact Test Results: Presence of Artefacts Total Yes No Q11.3 Screenfilm 24 x 30cm Count Contact cassette % within Test Q % 55% 100.0% 35 x 35cm Count cassette % within Q % 36% 100.0% Total Count % within Q % 45% 100.0% According to the results above 22 cassettes were assessed for presence artefacts in the screen-film contact test. Two sizes were assessed, eleven 24 x 30cm cassette and eleven 35 x 35cm cassette sizes. Of the 24 x 30 cm size cassettes, 6 (55%) hospitals cassettes demonstrated no artefacts while 5 (45%) hospitals had artefacts present. Of the 35 x 35cm cassettes, 4 (36%) hospitals cassettes demonstrated no artefacts and 7 (64%) hospitals cassettes presented with of artefacts. In total, 10 (45%) cassettes had no artefacts while 12 (55%) had artefacts. In terms of darkroom lighting efficiency in Question 11, there were two tests that were performed at the hospitals; safe lights fogging and white light leakage tests. Tables 4.10 and 4.11 below show results of cross tabulation between availability 90

105 of darkroom lighting efficiency and results of the two tests that were actually performed. Table 4.10 Availability of Darkroom Lighting Efficiency and Safe Light fogging Test Results (n=9) Q11.3 Darkroom Lighting Efficiency test Unmarked (1,3,4,14) Safe Light Fogging Test Results Fogging within No Fogging 0.5 minutes Total Count % within Q % 100.0% 100.0% Marked Count (7,8,9,10, % within 0.0% 100.0% 11) Q % Total Count % within 0.0% 100.0% Q % A safe light fogging test was conducted in 9 hospitals as indicated in Table Four (44.4%) indicated they do not perform darkroom lighting efficiency tests and 5 (55.6%) hospitals said they conduct the test according to Question 11 in the questionnaire for Radiographers in-charge. Test results showed that all the 9 (100%) hospitals had fogging of films within a period of half a minute. 91

106 Table 4.11 Availability of Darkroom Lighting Efficiency and White Light leakage Test Results (n = 12) Q11.3 Darkroom Lighting Efficiency Test Unmarked (1,3,4,6, 14) Marked (7,8,9,10, 11,12,13) White Light Leakage Test Results No Leakage Leakage within 2-5 minutes Leakage within 5-10 minutes Total Count % within Q % 75% 0 100% Count % within Q % 72% 14% 100% Total Count % within Q % 7 8% 100% According to the results in the table above, the white light leakage test was performed in 12 hospitals. All Radiographers in-charge from the 12 (100%) hospitals said they conduct darkroom lighting efficiency tests. After conducting the white light leakage testing in the 12 hospitals, only in 2 (16.6%) hospitals there was no leakage of white light into the darkroom from surrounding areas into the darkroom. In 8 (66.67%) hospitals there was white light leakage seen within 2 to 5 minutes. In the other 2 (16.6%) hospitals the white light leakage was seen within 5 to 10 minutes. 92

107 4.7 Conclusion Results of the study have been analysed from four different perspectives. Firstly, data was analysed from the results of questions from questionnaires directed to the Radiographers in-charge. Secondly data was analysed from the results of questions from questionnaires which Maintenance Officers/Hospital Administrators completed. Then data was analysed from test results from QC tests conducted. Lastly data was also analysed by performing cross tabulations between results of Question 11 from questionnaires completed by Radiographers in-charge on the availability of QC tests and the results of the actual QC tests the researcher conducted during the study. Questions from questionnaires Radiographers in-charge answered focussed on finding out the availability of QA committees and programmes in the X-ray department. Questions also included were on the availability of QC tests done in the departments, the person responsible for the QC tests and benefits that are realised from conducting the QC tests. Questions from questionnaires the Maintenance Officers completed focussed on finding out the availability of QA committees and programmes within the hospitals, the responsible person for the programme and reasons for the importance of having a QA committee. Five QC tests were conducted by the researcher in 12 X-ray departments. Tests done on the X-ray equipment; darkrooms and cassettes demonstrated poor results. In this chapter the results of the data collected was described and in the next chapter discussion on the findings are made and recommendations offered. 93

108 CHAPTER FIVE DISCUSSION AND RECOMMENDATIONS 5.1 Introduction In this chapter, findings of the study will be discussed and conclusions drawn on the status of QA and QC measures in diagnostic X-ray departments in Malawi. Recommendations emanating from the findings and conclusions will be made for submission to relevant authorities in Malawi for their consideration. 5.2 Demographic Data The study participants comprised of Radiographers in Charge of X-ray departments and Maintenance Officers/Hospital Administrators who responded to questionnaires given to them. The participants came from 4 central hospitals and 10 district hospitals selected from all the three regions of the country. Two district hospitals were from the northern region and 4 district hospitals from each of the central and southern regions. This represents 52% of all government hospitals that have functional X-ray equipment. Five different QC tests were also conducted to find out the current status of X-ray equipment performance in the hospitals. There was a 100% response rate of questionnaires from Radiographers in- Charge and an 85% response rate of questionnaires from Maintenance Officers/Hospital Administrators. QC tests were conducted in hospitals where possible and comprised of the following percentages: Beam alignment and collimation test in 85.7% of X-ray departments Constancy of radiation at different ma and time settings test in 42.8% of X-ray departments 94

109 Screen-film contact test in 78.5% of X-ray departments Safe lights efficiency test in 78.5% of X-ray departments White light leakage test in 85.7% of X-ray departments Coverage for QC tests was not 100% in hospitals because in some hospitals there was no electricity power available during the time of the study. Constancy of radiation at different ma and time settings tests were only conducted in 6 hospitals because in the other hospitals the equipment had no option of selecting ma and time separately to enable the test to be done. 5.3 Availability of QA Committees Findings from the study showed that there are no hospital QA committees in 11 of hospitals as compared to only 1 that has a QA committee. In all 12 hospitals there was no QA committee for the X-ray department. This is not optimal as quality of equipment and services cannot be monitored effectively. This is supported by Papp, (2006:9), Oakland and Porter (1995:101) who stated that a QA committee is essential for monitoring of QC activities and ensuring that financial resources are secured for QA programme implementation. Stevens (2001: 6-7) emphasized the importance of a QA committee for X-ray departments which ensures that criteria and standards for QC implementation are followed. Papp (2006:17) also stated that to have a comprehensive quality management programme, there must be administrative responsibilities which look at various activities of the programme and ensure that the processes of the programme are running smoothly. Oakland and Marosszeky (2006:29-30) stated that people, planning, processes and performance form the basis of total quality management in any organization. All these can be easily coordinated by a QA committee to ensure proper implementation of QA programmes. Clawson, (2003:1-2) and Novak and Van Keulen (2007:2,6) further stated that a QA programme should be lead by a Radiation Safety Officer or QA Programme 95

110 Officer to ensure consistency of test methods and interpretation of results for proper action to be taken. 5.4 Availability of QA Programmes On the availability of QA programmes for the hospitals as well as X-ray departments, the findings showed that there were no X-ray specific QA programmes in any of the 14 X-ray departments and only 1 hospital had a broad based documented QA programme for the whole hospital. This is in contrast to what is in the draft copy of the Malawi Radiography Policy document that stated The Radiology Department shall develop and maintain a quality assurance programme in accordance with standing guidelines (Ministry of Health, 2006:2). Papp (2006:17) also stated that there must be a section within the department that should be able to identify possible problems, risks to staff, patients and the public. He said by reducing such problems greater risks that can deplete financial resources for the hospital in the long term are prevented. Periard & Chaloner (1999:3) advocated that a QA programme is essential for testing and monitoring of equipment performance. According to Berquist (2008: ) a QA programme ensures production of quality output which brings confidence to customers, in this case patients. In Poland a law was enacted that all radiation producing equipment should have QA programmes to ensure quality radiographs and reduce the risk of radiation exposure (Wasilewska-Radwanska et al., 2005: 104). Much as the literature emphasizes the importance of having QA programmes, it is sad to find there is none available in X-ray departments in Malawi. There appears to be no system in place to check if QC tests are conducted or not and therefore the status of equipment performance becomes difficult to ascertain, as this study shows. 96

111 5.5 Availability of QC Tests Out of 14 hospitals, 9 Radiographers in-charge said they conduct some QC tests and 5 said they do not conduct any QC tests. Conducting QC tests is very important as this ensures monitoring of equipment performance and detection of faulty parts (Papp, 2006:193, Forster, 1993:154). Ball and Price (2006: ) stated that a QA programme should involve performing QC tests on different components of the X-ray department. According to results on the availability of QC tests conducted in X-ray departments, it was found that in many hospitals that said tests are conducted, not all required tests are conducted. In most hospitals just a few tests are conducted, for example, tests are conducted on the equipment but no tests are done in the darkroom or on cassettes. This is unacceptable practice as a fault in the darkroom can result in poor quality radiographs even if tests are conducted on the X-ray equipment. Ball and Price (2006: ) mentioned four major areas that need to be covered when conducting QC tests for a comprehensive QA programme, these being the equipment, the recording materials, processing area and reject analysis. The researcher found examples of test films in only 1 hospital out of 9 hospitals that indicated that they conduct some QC tests. This is not best practice as records of tests need to be kept for future reference and comparison when further monitoring of the equipment is performed. According to Dale, (2005:8) quality can be correctly judged in comparison with set standards. If there are no test films it is difficult to judge if the quality of services is improving or not because there is nothing to compare standards to. Without records and examples of test films done it is also difficult to believe if the QC tests were in fact really done. The head of the Radiography Department, according to the findings, is the only responsible person for QC testing in all the X-ray departments. In the absence of a QA committee evidence of which tests were actually done was difficult to establish. 97

112 It was also found that the Radiographers in-charge in the 9 hospitals had different views on whom to report the results of the QC tests to. The Radiographers in-charge at 4 hospitals said they reported the results to the electro-medical engineering department, 3 said they just kept the results themselves, 1 said results were reported to the District Health Officer and 1 did not know where or to whom the results should be reported to. This supports the point previously made that there is no standard system or programme in place for the hospitals to follow to ensure that QC tests are conducted and actions taken if there are any deviations from required standards. Although the Radiographers in-charge of the 9 hospitals do not have QC measures and tests in place they nevertheless identified four main benefits as outlined in Figure 4.3 in chapter 4 that could be obtained from performing QC measures and tests these being; fewer breakdowns of X-ray equipment, production of better quality radiographs, radiation protection of patients and the public and less down-time of X-ray equipment. In identifying these four areas it supports what Dale (2005:19) advocates that conducting QC tests improves quality of products and helps to reduce total costs used for maintaining equipment performance. Even though many QC tests are not done, the Radiographers in-charge do realise the importance of doing the tests. 5.6 Servicing of X-ray Equipment The results on whether the X-ray equipment in the hospitals was being serviced or not, showed that in only 5 hospitals Radiographers in-charge said that the equipment is serviced and in 9 hospitals, they said it was not. Sungita et al. (2006:1) stated that preventive maintenance measures of equipment are important as they ensure optimisation of quality performance. Equipment breakdowns occur due to lack of such maintenance which in turn incurs repair expenses. 98

113 The findings, with regard to servicing of X-ray equipment, identified that of the Radiographers in-charge from 5 hospitals, 3 Radiographers in-charge said the service was only done when a fault occurred. In 1 hospital the equipment was being serviced annually and in 1 other hospital it was serviced on a 2 to 3 years basis. When the researcher checked for records of past services done in the 5 hospitals, it was found that 3 hospitals had some records of past services done, these are, however, new hospitals that had maintenance agreements with manufacturers. These results show that there is very little done in ensuring that X-ray equipment in the country is regularly serviced as only 5 hospitals out of 14 reported that service is done and in only 3 hospitals were records of past services available. This lack of service and preventative measures leads to frequent breakdown of equipment with serious financial and service delivery consequences (Gotbaum, 2005: 1-2). 5.7 Importance of a QA committee Despite having no QA committees in most of the hospitals, all the Maintenance Officers/Hospital Administrators from 12 hospitals said it is important to have one and all of them gave different reasons for the importance of having a QA committee. This shows that even though most hospitals do not have these committees, the Maintenance Officers/ Hospital Administrators supported the views expressed by Papp (2006:9) on the value of QA programmes in the improvement of optimal use of equipment. 5.8 Status of X-ray Equipment Performance The researcher conducted QC tests to check the current status of X-ray equipment performance. Each test had separate results as discussed below. 99

114 5.8.1 Beam Alignment and Collimation Test Unless the X-ray tube is correctly centred to the mid-point the images produced become distorted as emphasized by Carroll (2003: ). The beam alignment and collimation test resulted in all 12 hospitals showing misalignment of X-ray tube to the light field but in 6 of the hospitals the X-ray tube was not centred to the mid point of the film. These results show that the beam limiting devices are not functioning correctly. As stipulated by Carroll (2007:134), for production of quality radiographs, beam limiting devices help in reducing radiation exposure to the patient and staff and increase the contrast of radiographic image. When the light field is not aligned and centred to the X-ray tube, then the beam limiting device is not serving its purpose. This needs serious attention to ensure that the X-ray tubes are correctly aligned to the light field to ensure there is no cut-off or over collimation of the area of interest which leads to repeat radiographs when X-raying patients Constancy of Radiation Output at Different ma and Time Settings On the test of constancy of radiation output at different ma and time settings, the results showed that out of 6 hospitals X-ray departments that could be tested only in 2 hospitals were differences in density noted and in 4 hospitals there were no differences. The results mean that most of the X-ray equipment produce constant radiation output according to the set mas. Lloyd (2001:58) emphasised that mas settings should be reliable to avoid producing images of lower or higher density than required, which leads to unnecessary repeats. 100

115 5.8.3 Screen Film Contact Test The loss of contact between screens and X-ray film and presence of foreign matter on screens causes loss of detail and sharpness on the final radiographic image as explained by Lloyd (2001:32-33) and Carlton and Adler (2006:322). Papp (2006:185) stated that the presence of foreign matter on screens is a result of the lack of cleaning of screens inside the cassettes after long use. There were two types of results obtained from the screen-film contact test. The first was uniformity of contact between screens and X-ray film which resulted in 8 (89%) out of 9 hospitals having good screen-film contact. The second result was the presence of artefacts on radiographs. This resulted in 6 out of 11 hospitals having artefacts present on radiographs for the 24 x 30 cm size cassettes and for the 35 x 35 cm cassettes 4 out of 11 hospitals reflected the presence of artefacts. The presence of artefacts as a result of the tests being done indicates that most of the cassettes are not regularly cleaned to remove debris on the screens. A point to note is that most of the departments were using cassettes of good condition that are not more than two years old. Most of the older cassettes were not being used Safe Light Efficiency Test Safe light fogging test was conducted in 9 hospitals and in all hospitals there was fogging of test films within 30 seconds in the darkroom. Fogging of films within 30 seconds shows that there is too much illumination during processing of X-ray films in the darkrooms. This is in contrast to what Papp (2006:35) stated, that typical X-ray films can remain unfogged within a safe light environment for about 40 seconds or more if safe lights are evenly placed and are of the required wattage without being fogged. Lloyd (2001:78) and Carlton and Adler (2006:295) said that a darkroom should be provided with low level illumination which is controlled by a number of bulbs, appropriate wattage, safe light filters and the 101

116 safelights conveniently laid out. Increased wattage of bulbs leads to fogging of film resulting in the production of poor quality radiographs (Papp, 2006:36). Most of the darkrooms were using high wattage bulbs not suitable as safe lights for X-ray film processing. In two of the hospitals they were processing films in complete darkness because they had no bulbs and filters. This makes it hard for Radiographers to work in such an environment White Light Leakage Test White light leakage test was done in 12 hospitals and the results showed that only in 2 hospitals was there no leakage of white light. In 8 hospitals there was leakage within 2 5 minutes and in 2 hospitals leakage started within 5 10 minutes. This means that in most darkrooms there is leakage of white light which fogs films during film processing. This is emphasised by what Papp (2006:33) stated that X-ray film exposed to white light unnecessarily increases its sensitivity leading to poor quality of radiographs. Guebert e. al. (1995:176) explained that physical check-up for leakage of white light should be regularly done within door frames, ceilings and any suspected places in the darkroom. This seems not to have been done in most hospitals. 5.9 Cross Tabulations Comparison was made between the actual results of QC tests conducted by the researcher and the results to availability of QC tests as answered by Radiographers in-charge in a questionnaire. Each QC test is discussed independently. 102

117 5.9.1 Beam Alignment and Collimation There were 8 hospitals where Radiographers in-charge said they conduct the beam alignment and collimation test and actual QC test results from all 8 (100%) hospitals had their X-ray tube misaligned to the light field. Centring of X-ray tube to the mid-point resulted in 5 (62%) out of 8 having good centring point. From four hospitals that did not mark the test to be done, all 4 (100%) had the X-ray beam misaligned to light field. On the centring of the X-ray tube from these 4 hospitals, 3 (75%) had their X-ray tubes off-centred. This means that even though the test is said to be conducted in some hospitals not much is done to ensure the beam alignment is corrected in the hospitals or the interpretation of the tests are not accurate. The results of the test from those that said they do not do the test are also poor (see Figure 4.7 on page 72 for an example of poor alignment of X-ray beam to the light field from one of the hospitals). Much more has to be done to monitor the equipment for beam alignment and collimation and appropriate action taken to correct the situation as beam limiting devices help to control radiation exposure to patients and improve image quality (Carroll, 2003:134) Constancy of Radiation Output at Different ma and Time Settings This test was conducted in 6 hospitals and from these only 2 Radiographers in- Charge said they conduct the test and 4 said they did not. From the 2 hospitals that said they do the test, the radiation output test was consistent at different mas settings while 2 out of 4 hospitals where the test is not done had inconsistency of radiation output at different mas settings. Consistency of radiation output at different ma and time settings need to be checked regularly to ensure consistent density on radiographs as stipulated by Carlton and Adler (2006:403). 103

118 5.9.3 Screen Film Contact Screen film contact test was reported to be conducted in all 9 hospitals. The same test was conducted by the researcher in all 9 hospitals. Only 1 out of 9 hospitals had cassettes of uneven contact between the screens and X-ray film. On the presence of artefacts on the screens, 22 cassettes from the 9 hospitals were assessed. The findings showed that on 10 out of 22 cassettes tested, artefacts were present on the screens. Gunn (2002:203) contends that objectives for performing screen film contact test include determining loss of contact and presence of scratches or abrasions which result in artefacts on X-ray films. These results reflect that many of the cassettes used are in good condition with uniform contact probably because most of them are not more than two years old, but would still require constant cleaning to remove foreign matter on screens (Papp, 2006:185; Carlton and Adler, 2006:327) Safe Light Efficiency Safe light efficiency test was conducted in 9 hospitals. From these hospitals, 5 Radiographers in-charge marked darkroom lighting efficiency test to be done and 4 said they do not do the test. In all 9 hospitals there was safe light fogging of films in the darkroom within 30 seconds. This poses a very big problem for the departments as quality of radiographs cannot be guaranteed because of fogging of films in the darkroom. Gunn (2002: 199) stated that safe lights used in darkrooms must provide a more acceptable environment with high level illumination for the darkroom worker without affecting the X-ray film being processed. Even though in some hospitals they said the test is conducted, it is difficult to ascertain this because there were no records of past test films and fogging of films still continues. Results from two hospitals were not analysed due to X-ray beam cut-off from the tube. This is also a serious problem that needs to be looked into as this leads to poor quality radiographs requiring repeat examinations and unnecessary increase of radiation exposure to patients and staff. 104

119 5.9.5 White Light Leakage White light leakage test was also conducted in 12 hospitals to check darkroom lighting efficiency. From the 12 hospitals, 7 Radiographers in-charge said they conduct the test and 5 said they do not conduct the test. From the 7 hospitals where the test is said to be done, there was only 1 darkroom that had no white light leakage, in 1 hospital darkroom leakage started within 5 10 minutes and 5 hospital darkrooms had white light leakage into the darkroom within 2 5 minutes. These results show that the test is not really rigorously conducted to check darkroom white lighting leakage. There were no records of past test films in most of the hospitals to show that the test was conducted. Fogging of X-ray films from white light leakage impacts negatively on quality of finished radiographs (Papp 2006:33) as X-ray film exposed to white light increases its sensitivity leading to fogging of films Lack of QA Programme According to findings from the study the lack of a QA programme for radiographic equipment could be as a result of the lack of a QA committee, no QC tests done, lack of trained personnel, lack of regular equipment service and lack of basic tools with which to do the tests or the lack of a quality policy in an organization. This is supported by the cause and effect diagram described by Goetsch and Davis (2006:491) as depicted in figure 2.1 in chapter 2 on page 13. This means if the causes leading to the problem of no existing QA programme can be identified, then a QA programme could be developed and implemented. 105

120 Figure 5.1 is the researcher s representation of such a cause and effect model. No QA committee No QC tests No test tools LACK OF QA PROGRAMME Lack of personnel Lack of equipment service No policy on quality Figure 5.1: An example of a cause and effect diagram for lack of a QA programme 5.11 Quality Costs Lack of QA committees and QA programmes in hospitals may have resulted in having no strategies on how to ensure there are enough funds for quality improvement. There are different types of quality costs that need to be considered for quality services to be provided and to be successful. High costs may result in fixing broken equipment if the situation is not corrected by introducing QA programmes in the hospitals. Goetsch and Davis (2006:45) stated that quality improvement reduces the cost of running a service and leads to satisfaction of customers, in this instance, the patients. 106

121 5.12 Recommendations Based on findings and data analysed from the study the researcher offers the following recommendations to relevant authorities related to X-ray department services and maintenance of medical equipment in hospitals in Malawi Ministry of Health in Malawi The Ministry of Health is the biggest provider of health services in Malawi especially through its government hospitals and clinics in the country. As such it is within its mandate to ensure that quality services are provided in the hospitals. To date the 2006 radiography policy on quality has not been implemented. Policies should be introduced locally to ensure that strategies are put in place concerning the implementation and maintenance of quality services in hospitals for example policies on radiation safety or QA programmes. Policies should include monitoring and maintaining equipment performance to avoid breakdown of equipment which becomes more costly in the long term. These policies will guide the hospital management to ensure that quality services are provided by all departments in hospitals. Policies will also help hospital management to secure enough resources for intended projects and activities directly related to maintenance of X-ray equipment thus ensuring quality services to the public. QA programmes can easily be coordinated by a Radiation Safety Officer or QA Programme Officer in the Ministry. As seen in many other countries, the government should initiate the formation of a Radiation Council/Board to take responsibility for the use of radiation producing equipment in the country to ensure safety and provision of quality services. The council or board would be responsible for the certification of new equipment, introducing QA and QC training programmes for radiographers, ensure the implementation of QA programmes for the equipment during use and condemning and disposing of old equipment. QA programmes would reduce malfunctioning of equipment because 107

122 of constant monitoring. As seen from the literature, the WHO strategies are not expensive to implement (Appendices 5 9, Lloyd, 2001:30, 33, 58 and 79). The researcher thus recommends that these inexpensive and uncomplicated tests are done on a regular basis and corrective measures such as simply replacing the light bulbs with the required wattage are done The Hospital Management Team The Hospital Management Team is responsible for ensuring that activities pertaining to health delivery service are properly coordinated and implemented within the hospital. It is the duty of this team to ensure that all departments of the hospital have adequate tools and equipment for providing health services. The team should introduce a QA committee for the whole hospital which can work in collaboration with the Maintenance Department to introduce and coordinate QA programmes for the hospital. QA sub-committees for individual departments of the hospital should also be introduced to directly implement and monitor different QC measures and tests appropriate to each department. QA programmes for hospitals will help to keep hospital equipment in good condition thereby avoiding incurring huge financial expenses to replace or fix broken equipment. Hospitals, with the help of QA committees, should strategise on how to source funds to cater for the different categories of quality costs to enable successful QA programmes. The Maintenance Department of the hospital should take responsibility for introducing QA committees and QA programmes for easy monitoring of equipment The X-ray Department Radiographers in X-ray departments have the responsibility for ensuring the provision of quality service to patients. An undiagnostic radiograph can lead to misdiagnosis of the patient's condition and this could result in detrimental effects 108

123 for the patient. Radiographers have to monitor performance of X-ray equipment from time to time as stipulated by WHO standards. QC tests are supposed to be conducted regularly to make sure the equipment is well maintained. Lack of regular testing results in frequent breakdown of equipment, which requires more funds from the government to fix or replace the equipment. QA committees have to be introduced for the X-ray departments to make sure that all QA programmes are implemented and well monitored and results of all QC tests have to be kept for future reference. The introduction of a radiation control board or equivalent would, as others in the world, have as part of its mandate a system of checks and balances, record keeping and regulations relating to X-ray and other ionising radiation producing equipment Conclusion According to results from the study there are no QA programmes and QA committees in most hospitals and none in any X-ray departments in government hospitals. In most X-ray departments QC tests are not conducted and for those that indicated they do, there were no examples of test films to confirm that the tests are indeed conducted except in one case. A hospital needs to have a QA committee to ensure proper implementation and monitoring of the QA programme in all departments of the hospital. The lack of QA programmes for the X-ray equipment in Malawi has led to frequent breakdown of machines and poor quality of radiographs resulting in greater risks of ionizing radiation. Radiographers in-charge also have to take responsibility to ensure that the condition of X-ray equipment is well monitored and faulty parts replaced to avoid frequent breakdowns. On the basis of the research done, it is apparent that not all X-ray equipment in Malawi is functioning optimally. This was highlighted and substantiated in the results chapter. It is thus recommended that the draft Malawi Radiography Policy document that states The Radiology department shall maintain a quality 109

124 assurance programme in accordance with standing guidelines is finalised and implemented. In addition it is suggested that a workshop on the implementation of the WHO tests as outlined in appendices 5 9 is co-ordinated by the Ministry of Health as the custodian of the draft Malawi Radiography Policy document. The researcher offers his input in this regard in anticipation that an effective QA programme for Radiographers in-charge of X-ray departments is developed. The QA instruments donated to the researcher could assist in this process. The ultimate outcome of an effective QA programme is to achieve optimal operation of X-ray equipment, X-ray accessories and darkroom with subsequent improved service to the patient and enhanced patient care and management. A copy of this research will be submitted to the Ministry of Health, the Hospital Management Team and the Radiographers in-charge of the relevant X-ray departments for their consideration. 110

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132 Appendix 1 Harvest M. Chinamale University of Johannesburg Faculty of Health Sciences P. O. Box Doornfontein Johannesburg Republic of South Africa The Director of Technical Support Services Ministry of Health P. O. Box Lilongwe 3 Malawi Dear Sir, APPLICATION FOR PERMISSION TO CONDUCT RESEARCH I am a Radiography student at the University of Johannesburg studying for a master s degree. I am writing to request your office for permission to conduct research study entitled An Investigation into the Status of X-ray Equipment and Quality Control Measures in Malawi. The main purpose of conducting this study is to establish the status of x-ray equipment and quality control measures with the aim of improving performance, thereby improving the quality of radiograph production with minimum radiation risks. Data will be collected by checking records on the availability, if any, of QC activities with regard to the X-ray equipment. In addition, various tests on quality assurance will be necessary to establish the status of the X-ray machines. The tests will be done by the researcher. 118