(PACS) for Digital Mammography

Evaluating the impact of using Picture Archiving and Communication System (PACS) for Digital Mammography: Nottingham University Hospitals NHS Trust case study January 2014

Adrian Adewunmi Information School, University of Sheffield, Regent Court, Sheffield, South Yorkshire S1 4DP [email protected]

Acknowledgements: This work was undertaken as part of the fulfilment for a Masters in Health Informatics.

Unpublished Report

Abstract Currently, the NHS Breast Cancer Screening Program (NHS BCSP) is pursing a campaign for the adoption of digital mammography systems into breast screening, which is aligned with governments’ national programme for IT (NPfIT). The NPfIT through the NHS Connecting for Health (NHS CfH) now called Health and Social Care Information Centre (HSCIC) supports the NHS BCSP through the delivery of digital x-rays and scans using PACS technology to NHS trusts in England. This technology replaces the previous method of capturing x-rays and scans on film and paper, enabling clinical images to be stored electronically, viewed on screen and at multiple locations (HSCIC, 2013(a)). PACS transforms a patient’s experience of the care they receive in a number of ways i.e. potentially quicker discharge from hospital and better care planning resulting from easier access to images and test results (DOH, 2002). However, will the application of PAC for digital mammography lead to improved diagnostic accuracy of breast cancer, and indeed achieve improvement in patient safety and quality of care? This essay will evaluate the usefulness of PACS for digital mammography in England using SWOT analysis. In addition, assess through a case study the clinical and non clinical value of PACS in supporting digital diagnostic screening in a particular secondary care setting.

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1. Introduction Breast cancer is a type of cancer which starts within breast tissue, particularly from the inner lining of milk ducts or the lobules that supply the ducts with milk (Sariego, 2010). In 2008, breast cancer accounted for 22.9% of all cancers (excluding non-melanoma skin cancers) in women and caused 458,503 deaths worldwide (IARC, 2013). Breast cancer is the most common cancer in the UK, with an estimated 48,000 women getting breast cancer, mostly aged over 50 (NHS choices, 2013). The precise causes of breast cancer are not fully understood, but many factors increase the chances of developing it, such as age and family history. Women known to have a high possibility of developing breast cancer may be offered screening for the condition (Anderson, et al., 2008). The NHS Breast Screening Programme (NHS BCSP) was launched in England in 1988, (Forrest, 1986) proposing that all women at risk of breast cancer aged 50–70 be invited for breast cancer screening every three years (Cancer Research UK, 2012). Usually, screening takes place at a designated clinic, a mammogram (X-ray image of the breast) is taken and then studied to look for any abnormalities in the patients breasts. The aim is to detect breast cancer at an early stage, when any changes in the breast may be too small to feel and when there is a significant potential of successful treatment and full recovery (Macmillan, 2011). There are two common methods of recording mammogram screening i.e. an X-ray film or digital image (Hermann, Obenauer, Funke, & Grabbe, 2002). The main difference between these two systems is the method of capturing, storage and retrieval of images (Fischer, et al., 2002). X-ray images are captured using X-ray machines and images are stored and retrieved as hard copies. Conversely, digital images are captured, stored and access through computer work stations which form part of the Picture Archiving and Communications Systems (PACS) (Del Turco, et al., 2007). As PACS are currently being deployed all across England, the Health and Social Care Information Centre (HSCIC) which succeed the NHS Connecting for Health (NHS CfH) is supporting NHS trusts with a national clinical image digitalisation initiative, whereby PACS supports the NHS national breast cancer screening programme efforts to implement digital mammography (DM) across England (HSCIC, 2013(a)). In 2010, the Department of Health (DOH) Advisory Committee on Breast Cancer Screening choose direct digital technology (DR) as the selected option for the introduction of digital mammography (DM) into the NHS BSP. Whereas conventional mammography captures images of breast tissue on xray film, DM uses computer imaging.This is being rolled-out across the NHS BSP in England and as at 2011, an estimated 85 per cent of breast screening units have at least one digital mammography set (NHS BCSP, 2013). The immediate benefit of deploying PACS for DM is an increased capacity of diagnostic services as well as quicker turn around time in the radiology department (Gamsu & Perez, 2003). Furthermore, this means fewer delays or missed appointments’ for patients, due to lost or low quality images (Tan & Lewis, 2010). Potentially, quality of care will be improved where clinicians at different locations can share images and make more informed medical decisions (Faggioni, Neri, Castellana, Caramella, & Bartolozzi, 2011). This essay will evaluate the usefulness of PACS for DM in England using SWOT analysis. Additionally, it will assess through a case study the clinical benefit of PACS supporting DM in a

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particular secondary care setting. This essay is divided into the following sections, consecutively: Background, Integrated Architecture of PACS, Case Study, Discussion and Conclusions.

2. Background The DOH issued its latest strategy for developing IT in the NHS in 2002, delivering 21st century IT Support for the NHS – “The National Programme for IT” (NPfIT) and created the NHS CfH in 2005, mandated with the task of delivering the NPfIT Programme (DOH, 2002). With projected costs estimated at £12.4 billion for the ten years to 2014; national and local systems and services for the NPfIT are being developed and delivered by 5 NHS local service providers, each covering different regions of the UK (Chantler, Clarke, & Granger, 2006). These include services like GP Systems of Choice (GPSoC), national system such as the NHS Care Records Service (NHS CRS) and local systems like the PACS (See figure 1) (NHSTA, 2009). Given the huge amount of public spending on the PACS programme, there continues to be considerable political, economic, social, technological legal, environmental scrutiny (PAC, 2011).

Figure 1: Outline of deliverables within the NHS IT programme (Hendy, Fulop, Reeves, Hutchings, & Collins, 2007) PACS are designed to capture, store, distribute and display static or moving digital images such as Xrays and scans, through linked personal computers, with a view to providing a more accurate diagnosis and effective treatment (Pilling, 2003). Essentially, PACS will enable stored digital images become integral to every NHS patient’s electronic record, eventually obliterating the need to print Xray to film and to store and distribute such clinical images manually (Saywell, 2010). As at the end of 2007, total cost for the central PACS data stores was £245 million with 121 CfH PACS rolled out across England, deployments at 95% compete, over 437 million images stored and approximately 19 million studies have been performed (Car, et al., 2008). The development of PACS has over the years reached an advanced stage whereby it can be stated that such technology in a clinical setting is readily available (Lemke, 2011). However, such systems do not stand alone, but function as part of an information system, more or less interconnecting with each other. PACS, Hospital Information System (HIS), Radiology Information System (RIS) and other departmental systems interact with each other storing, exchanging and delivering patient information as a single record in a variety of clinical settings and different components of the patients’ records are Page | 3

stored in different systems distributed in the hospital (Levine, Mun, Benson, & Horii, 2003). The integration of all these systems into a functional whole is determined by the radiologist's need of quick access to all relevant information regardless where it is stored. The integration of PACS, RIS, HIS and all other inter-related systems in the hospital contribute to the clinical benefits of PACS (Nitrosii, et al., 2012). Figure 2 displays the workflow process before and after the implementation of PACS in a typical radiology department.

Figure 2: Pre and Post PACS workflow (HSCIC, 2013(b)) The impact of DM on early diagnosis of breast cancer is controversial, and for women diagnosed with benign lesions, DM can have both psychological effect and financial cost (Saslow, et al., 2004). Boyd et al. (2007) states that DM has the potential to increase detection of breast cancer, especially in women who have extensive mammographic density and in whom the risk of breast cancer is greatest (Boyd, et al., 2007). On the other hand, computer aided detection of inconsistencies in digital mammograms have been associated with reduced accuracy of interpretation of screening mammograms (Fenton, et al., 2007). Most women participating in mammography screening programs accept the risk of false negative recall, and majority find it very distressing (Murphy, et al., 2007) Sometimes a false negative can result from a considerable variation in interpreting a DM image by a consultant radiologist (Wang, Shih, Hsu, & Li, 2000). The same image may be declared normal by a radiologist and suspicious by another (Siegal, Angelakis, & Hartman, 2008). On the other hand, Harvey et al. (2003) report an increase in cancer detection as a result of independent double interpretation of screening mammography (Harvey, Geller, Oppenheimer, Pinet, Riddell, & Garra, 2003). A study by Barlow et al (2004) discovered no correlation between greater experience of a radiologist and a more accurate interpretation of mammograms (Barlow, et al., 2004). It can be helpful to compare the images to any previously taken images, as changes over time may be significant (Venta, et al., 2001). In future, digital mammography offers opportunities of advanced

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processing such as digital tomosynthesis and contrast enhanced mammography, and the possibility of hybrid breast imaging systems (Schulz-Wendtland, Fuchsjäger, Wacker, & Hermann, 2009).

3. Integrated Architecture of PACS Under consideration is the Fujitsu PACS (see figure 3) (FUJITSU, 2013).

Figure 3: Snapshot of Fujitsu Picture Archiving and Communication (PACS) for the NHS (FUJITSU, 2013)

a) Technical aspects of the FUJITSU PACS system PACS aims to give NHS staff access to digitally captured images, centrally stored and distributed to multiple locations, thus providing clinicians’, quick and efficient access to patient information. The use of PACS causes operational issues such as Digital Imaging and Communications in Medicine (DICOM) (ISB, 2010) Modality Work list (DMWL) issues. A work list (i.e. computed tomography, patient demographics and study information) provided by the RIS, PACS or PAC broker, should match the studies to be performed at any other modality, such as cardiology. Some modality work list providers give too much data (e.g. all of the exams for all modalities) or not enough differentiation (e.g. only specific scans). A standardised approach to DMWL provision is important in supporting storage of DICOM images (Kuzmak, Dayhoff, Gavrilov, Cebelinski, Shovestul, & Casertano, 2012).

b) Architecture of the FUJITSU PACS system PACS supports RIS, an inter-related part of a typical HIS which incorporates other clinical systems (see Figure 4). The RIS is central in supporting image management and reporting workflow. The RIS and PACS are integrated systems which communicate through HL7 communication protocols (Dolin, et al., 2001). RIS sends new and updated reports to PACS, providing demographic and exam request information using the Integrated Healthcare Enterprise (IHE) workflow integration framework. Both the HIS and RIS interface with PACS via the PACS broker, sending the DMWL to modality (FUJITSU, 2013). Page | 5

Radiology Information Sytem (RIS)

Pharmacy Information System (PIS)

Picture Archiving and Communication System (PACS)

Patient Administration System (PAS)

Laboratory Information System (LIS)

Electronic Patient Record (EPR) Figure 4: Architecture of the Clinical components of a Hospital Information System which includes PACS

c) Implementation FUJITSU PACS system The NHS CfH supports the delivery of systems for the NPfIT programme (DOH, 2002), which includes the PACS, amongst others (NHSTA, 2009). Figure 5 shows a schematic model of the interrelation that exists between PACS other critical IT systems within the context of a national healthcare programme, for the delivery of shared services to NHS staff and institutions (Cresswell & Sheikh, 2009). Strategic, PACS falls within "level 6" of the NHS information strategy (NHS Executive, 1998). In addition, the CRV is at "Stage 5/6" of the HIMSS Analytics Europe's EMR Adoption Model (EMRAM). This standard identifies the levels of electronic medical record (EMR) capabilities (HIMSS, 2010).

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Figure 5: PACS as part of NPfIT system (Cresswell & Sheikh, 2009) 4. Case study The Nottingham University Hospitals NHS Trust (NUH NHS) was formed in 2006, and provides general and specialist services, including cancer and associated specialties (Nottingham University Hospitals NHS Trust, 2012). The Nottingham Breast Institute provides all outpatients services for those requiring breast cancer screening and is primarily conducted using DM as a diagnostic tool. From 2006, medical images have been captured, stored accessed on PACS (Nottingham Breast Institute, 2013).

a) Objective Pre-PACS, the NUH NHS analogue system for capturing medical images on X-ray film required an annual expenditure of over £1m for wet film processing. In addition, 80% of inpatient X-ray films were not reported; 40% of out-of-hours inpatient films were not reviewed by clinicians; and non-reported inpatient X-rays missed 35% of significant diagnostic abnormalities. (Fearn, 2009) As a result, NUH NHS sort to purchase a PACS, with the expected benefit of “improved patient safety”; in line with NPfIT strategy to make the NHS film less and paperless (DOH, 2002).

b) Results After the installation of the PACS in 2006, the Nottingham NHS trust achieved the following results (Fearn, 2009): i.

ii.

Improved Workflow: Post PACS has seen a progressive reduction in the average turnaround time for medical image capturing and reporting from 80 hours to 38 hours. Furthermore, 68% of digital films are now verified within 48hrs, compared to 27% previously. Financial Recovery: A recurrent yearly savings of over £1m due to a substantial reduced cost of film processing and minimal use of clerical staff.

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c) Benefits The benefits of the PACS implementation are (Fearn, 2009): i.

ii.

In two weeks after deployment, there was an 80% increase in the use of digital medical imaging using the PACS. This exceeded the expectation of 40% in one year. Patient pathway for direct booking and access of certain cancers to attend diagnostic testing and treatment has improved by becoming: quicker and more efficient.

d) Comment An assessment of the NUH NHS Trust case study clearly indicates the clinical benefit for medical staff and hospital administrators of digital over analogue medical imaging for breast cancer screening, with other case studies demonstrating similar outcomes (Visbion, 2012), (Worcestershire Acute Hospitals NHS Trust, 2009). However, the NUH NHS case study does indicate that DM using PACS will lead to accurate diagnosis, early treatment, or improvement in patient safety and quality of care.

5. Discussion This section of the essay will evaluate the usefulness of PACS in England using SWOT analysis.

a) Strengths i.

Improved workflow: a. The use of PACS leads improved access to new / archived images; identifying relevant prior studies that exist only on film, as well as reducing physical space requirements for images. Thus, images are always available, so no patient appointment is cancelled or screening tests repeated (Tellis, Andriole, Jovais, & Avrin, 2002). b. The PACS database ensures that all images are automatically grouped into the correct examination, are chronologically ordered, correctly orientated and labelled, and can be easily retrieved using a variety of criteria (for example, name, hospital number, date, referring clinician, etc) (Strickland, 2000).

ii.

PACS has improved organisational efficiency through eliminating the manual handling of paperwork. Thus no clinical diagnostic decision deferred, and no time is wasted by doctors or other healthcare workers looking for missing films or paperwork. Thus increased productivity of radiology services (Ralston, Coleman, Beaulieu, & Perkins, 2004).

iii.

The availability of numerous PACS terminals throughout a hospital allows simultaneous multi-location viewing of the same image, significantly reducing the time required to reach a final diagnosis,

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whereas conventional film can only physically exist in one place at anytime (Hirschorn, Hinrichs, Gor, Shah, & Visvikis, 2001).

b) Weaknesses i.

Although the process involved in the examination of patients in radiology is shorter using PACS, access to digital images can sometimes be impeded by the new workflows; where on occasion, images do not arrive from the PACS to the right patient map / directory (van de Wetering, Batenburg, Versendaal, Mis, & Firth, 2006).

ii.

With the implementation of PACS, there is a requirement to guard against a total system failure, as a hospital’s most important function is the imaging service. There is no “restore from back up position” once the hospital has become filmless because the means and infrastructure to generate, distribute, view, and store hard copy film no longer exists (Strickland, 2000).

iii.

The NPfIT promises outstanding benefits for patients and throughout the NHS. However, the immediate hurdle is the interruption and transformation that NHS staff will experience during implementation of the NPfIT systems such as PACS (Hendy, Reeves, Fulop, Hutchings, & Masseria, 2005). With the deployment of PACS, it is feared that medical staff will not have sufficient computer literacy to be able to use the new technology (Law & Zhou, 2003).

c) Opportunities i.

Environmental Currently, there is a lot focus on the socio-technical issues that pertain to the design and deployment of eHealth technologies (Black, et al., 2011). Human factors influence the design of an intervention and organisational issues are important in strategising deployment. The interface between technology and human characteristics are environmental drivers influencing the impact of PACS in delivering eHealth strategies (van Gemert-Pijnen, et al., 2011).

ii.

Social With the use of data from clinical PACS, the disease registries and databases (NRID) of neurological diseases may be created, and keyword searches may produce lists of patients with specific diagnoses. In the field of brain tumour imaging, this may represent a small but significant step towards a comprehensive research database, especially as it can contain rich radiological imaging data held within PACS (Yang, Tan, Loh, & Lim, 2007).

iii.

Technological Medical diagnostic imaging procedures have steadily evolved over the last decade, with a significant impact on storage and retrieval capabilities of current PACS. With the huge financial outlay involved in migrating from a paper and film based system to a PACS, cloud computing, may help address this emerging image access requirement (Silva, Costa, & Oliveira, 2012). Page | 9

d) Threats i.

Political The UK coalition government announced the reorganisation of the NHS in July 2010, bringing major changes to the role of the DOH. This has had a number of implications for the future of the nations IT Programme. Some contracts with LSP for NPfIT systems such as the PACS, which are in regular use across the NHS, come to an end as soon as June 2013. The DOH will have to seek options for dealing with the uncertainty regarding the future of NPfIT systems (NAO, 2011).

ii.

Legal The sharing of medical digital images can be implemented in a variety of settings i.e. within a healthcare organisation, within borders and across country borders. Challenges without crossing country borders are technical in nature i.e. Interoperability. At the cross country level, more prevailing are issues surrounding legal implication of shared images (Ross & Pohjonen, 2011).

iii.

Economic There is growing concern within the NHS about availability of finance to cover costs associated with IT modernisation. In particular, applications such as PACS supplied through local service providers' (LSP's) for the NPfIT strategy in England seem more expensive than market alternatives (Hendy, Fulop, Reeves, Hutchings, & Collins, 2007).

e) Comments Policy makers predict PACS will yield reliable quality of images, by eliminating the problem of black spots on images due to bad light (Nishikawa, 2007). For the purpose of breast cancer detection, DM is more accurate as compared with film mammography (FM) for detecting small masses in mixed and dense women’s breast (Pisano, et al., 2005), (Yang, et al., 2006). Furthermore, there is an anticipated benefit of improved quality of care, demonstrated by a speedier move to the next point of treatment or discharge, resulting in better care planning (Reeves, et al., 2007). Conversely, Horii et al. (2000) investigate the effectiveness of introducing PACS to a radiology department and discovered PACS slowed technologist workflow by prolonging the quality-control procedure (Horii, Feingold, & Kundel, 2000). In addition, DM screening may produce false negative results, due to considerable variation in interpreting the digital images (Barlow, et al., 2004). Finally, efficiency gains from healthcare IT systems are difficult to quantify, so assumptions of substantial improvement in quality of health from healthcare IT systems might be unrealistic (Collin, Reeves, Hendy, Fulop, Hutchings, & Priedane, 2008).

6. Conclusions This aim of this essay is to analyse the strengths, weaknesses and benefits of using PACS in England. There is evidence to demonstrate the short run clinical and financial benefits of PACS, but it is unknown whether the long run benefit of PACS will be accurate diagnosis, early treatment, or improvement in patient safety and quality of care. However, the over riding question is whether lives Page | 10

have been lost through the absence of, or saved, through the availability of DM using PACS. At the moment, research evidence to support or dispute this hypothesis is scant, so it is difficult to come to a reasonable conclusion. At this present time, the focus should be on a three fold challenge: developing more innovative techniques for sharing digital images nationally and locally, while complying with DICOM, IHE and other interoperability standards; pursue e-health systems and services that have shown potential clinical benefits; preparing for financial implications of the structural changes to the NHS.

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