Epilogue

Today’s filmless radiology through PACS provides greater speed and superior image quality. However, when workflow is encumbered by inefficiencies, the benefit to the organization – and ultimately the patients – may not be fully realized. Even with the latest equipment installed, many organizations face delays in report-turnaround time and a backlog of patients waiting for appointments. Diminished security and quality can lead to a variety of problems for filmless radiology facilities or departments, including: • Delay in diagnosis and treatment • Emergency department bottlenecks • Increased length of stay • Patient dissatisfaction • Referring physician dissatisfaction • Potential loss of outpatient business • Loss of revenue • Poor public image

PACS Monitoring

The present study advocates the application of statistical process control (SPC) as a performance monitoring tool for a PACS. The objective of statistical process control (SPC) differs significantly from the traditional QC/QA process. In the traditional process, the QC/QA tests are used to generate a datum point and this datum point is compared to a standard. If the point is out of specification, then action is taken on the product and action may be taken on the process. To move from the traditional QC/QA process to SPC, a process control plan should be developed, implemented, and followed. Implementing SPC in the PACS environment need not be a complex process. However, if the maximum effect is to be achieved and sustained, PACSSPC must be implemented in a systematic manner with the active involvement of all employees from line associates to executive management. SPC involves the use of mathematics, graphics, and statistical techniques, such as control charts, to analyze the PACS process and its output, so as to take appropriate actions to achieve and maintain a state of statistical control. While SPC is extensively used in the healthcare industry, especially in patient monitoring, it is rarely applied in the PACS environment. One may refer to a recent SPC application that Mercy Hospital (Alegent Health System) initiated after it implemented a PACS in November 2003 (Stockman & Krishnan, 2006). The anticipated benefits characteristic to PACS through the use of SPC include: • Reduced image retake and diagnostic expenditure associated with better process control. • Reduced operating costs by optimizing the maintenance and replacement of PACS equipment components. • Increased productivity by identification and elimination of variation and outof- control conditions in the imaging and retrieval processes. • Enhanced level of quality by controlled applications. SPC involves using statistical techniques to measure and analyze the variation in processes. Most often used for manufacturing processes, the intent of SPC is to monitor product quality and maintain processes to fixed targets. Hence besides the HSSH techniques, the proposed TQM approach would include the use of SPC. Although SPC will not improve the reliability of a poorly designed PACS, it can be used to maintain the consistency of how the individual process is provided and, therefore, of the entire PACS process. A primary tool used for SPC is the control chart, a graphical representation of certain descriptive statistics for specific quantitative measurements of the PACS process. These descriptive statistics are displayed in the control chart in comparison to their “in-control” sampling distributions. The comparison detects any unusual variation in the PACS delivery process, which could indicate a problem with the process. Several different descriptive statistics can be used in control charts and there are several different types of control charts that can test for different causes, such as how quickly major vs. minor shifts in process means are detected. These control charts are also used with service level measurements to analyze process capability and for continuous process improvement efforts.

PACS Failure Mode and Effects

There are some medical errors for which preventability is rarely questioned. These include medical errors such as wrong site surgery, wrong procedure, wrong patient operations (Seiden & Barach, 2006; Michaels et al., 2007; Lee et al., 2007), wrong drug/dose/duration (Pugh et al., 2005) or incompatible organ transplantation (Cook et al., 2007). Less preventable medical errors include judgment type errors such as case studies reported in journals, where one or more experts review the treatment decisions of a clinician and conclude that the clinician’s judgment was incorrect (Lukela et al., 2005). Many healthcare managers first heard about Failure Mode and Effects Analysis FMEA when Joint Commission on Accreditation of Healthcare Organizations (JCAHO) released its Leadership Standards and Elements of Performance Guidelines in July 2002 (JCAHO, 2002). The purpose of performing an FMEA for JCAHO was to identify where and when possible system failures could occur and to prevent those problems before they happen. If a particular, failure could not be prevented, then the goal would be to prevent the issue from affecting healthcare organizations in the accreditation process. FMEA is a tool that when performed adequately, can reduce the risk of preventable medical errors. Hospitals in the United States that are accredited by JCAHO are required to perform at least one FMEA each year. The main output of FMEA is a series of mitigations, each of which is some process change implemented to reduce the risk of error. Because resources are limited, implementing all mitigations is not possible so the challenge is to find the set of mitigations that provides the highest reduction in risk for the least cost. Hence, preventability may be viewed in terms of the cost and effectiveness of mitigation. A low-cost and effective mitigation is associated with a highly preventable medical error, whereas a high-cost and or less effective mitigation is associated with a less preventable medical error. Currently AAPM TG 100 (2007) is reviewing reports from previous task groups and from several professional organizations. This group is also reviewing ISO guidelines in an effort develop a suitable general QA approach that “balances patient safety and quality versus resources commonly available and strikes a good balance between prescriptiveness and flexibility.” The TG 100 initiative identifies three industrial engineering–based tools as potential components of a QA management system in radiation therapy and FMEA is one of them.

PACS Network Traffic Control

Economically speaking, it is interesting to see that over the years, the question as to whether PACS is cost-justifiable has not been easier to answer. The early work at the hospital of the University of Pennsylvania, as well as at Washington University in Seattle, provided some early numbers and a framework to use, however, a clear “savings-model” is still difficult to formulate. The challenge is that one cannot just look at how much is saved by eliminating film, but that the true savings lie more in the increases in efficiency. Productivity studies by the VA in Baltimore in the early 1990’s have helped in this regard. However, one has to realize that, as Dr. Eliot Siegel from the VA in Baltimore strongly advocates, one has to re-engineer a department and its workflow to make use of the advantages of this new technology to really realize the benefits. As one can imagine, the early PACS only replaced their film-based operation with a softcopy environment without emphasizing re-engineering. That brings us to one of the big “drivers” in this technology: network standardization. In the early 1980’s, there was no one single standard. Transmission Control Protocol and the Internet Protocol (TCP/IP) was just one of the several options available. The United States government was pushing for the Open Systems Interconnection (OSI) standard.

Design for PACS Reliability

Nowadays it is hard to think of any applications in modern society in which electronic systems do not play a significant role. In aerospace and aviation, defence, telecommunication and healthcare, to name a few, computers have already assumed the most life-critical tasks. Unlike most human beings, computers seem to do their job pretty well, at most times and under all environmental conditions. Sometimes, however, for some reason, the fresh water supply in a city stops, the mainframe computer of an international security exchange centre malfunctions, or the satellite television goes out abruptly. Possible sources for such dissatisfactory performances are physical deterioration or design faults in hardware components. Fortunately in the 1950s and 1960s quite a number of reliability models were developed for hardware. Another major source for malfunctioning of computer systems is the presence of bugs in the software that controls the system. The modelling of software reliability was only begun in the early 1970s. This chapter presents a comprehensive approach to the development of a reliable PACS, which are capable of meeting the high-quality level required of mission-critical medical devices. To develop a preliminary design, the PACS team would begin with a system description and reliability evaluation of a baseline system, includ ing implementation of hardware redundancy, software provisions, and acceptance test. Through detailed system analyses and electrical, electronic and mechanical reliability studies, a final preliminary design can be derived. In this chapter the essential mathematical and statistical aspects of hardware and software reliability predictions are first presented, followed by a spreadsheet-based approach to model hardware and software reliabilities. A method of designing higher system reliability through parallel and cross-linked configurations is then given. Finally a brief case on the acceptance test of a PACS software is illustrated.

Customer Oriented PACS

During the early development phase of PACS, its implementation was mainly a matter of the radiology department. This is changing rapidly, and PACS planning is increasingly seen in the context of a hospital-wide or regional approach. With increased networking among healthcare institutions and the growing relevance of teleradiology scenarios, PACS strategies must take not only local but also regional and global factors into consideration. For hospitals and healthcare institutions, quality function deployment (QFD) is a helpful tool for developing new systems or services. QFD was originally developed by Yoji Akao in 1966 when the author combined his work in quality assurance and quality control points with function deployment used in Value Engineering. QFD has been described as “a method to transform user demands into design quality, to deploy the functions forming quality, and to deploy methods for achieving the design quality into subsystems and component parts, and ultimately to specific elements of the manufacturing process” (Mizuno & Akao, 1994). QFD is designed to help planners focus on characteristics of a new or existing product or service from the viewpoints of market segments, company, or technology-development needs. The technique yields graphs and matrices. It is widely accepted that benefits of using QFD in the healthcare industry include: • Increased customer satisfaction • Improved quality • Time efficiency • Multidiscilplinary teamwork orientation • Documentation orientation The QFD method has been successfully applied to many industrial and manufacturing processes in order to ensure that quality is built into products at the outset rather than tested for after their production. However, this method has rarely been applied in the healthcare industry.

PACS Quality Dimensions

A large number of studies have attempted to identify the factors that contribute to good PACS quality, such as that shown by Reiner et al (2003). Results from these studies (Bauman, 2000; Ralston, 2000) reveal that the success of PACS requires healthcare organizations and managers to adequately address various types of challenges: technological (e.g., integration with other information systems), managerial (e.g., project management), organizational (e.g., availability of resources), behavioural (e.g., change management), and political (e.g., alignment among key participants). Most investigations have considered a single, or at best, a small number of factors contributing to a fragmented view of PACS success. Broadly, these studies may be classified into those that consider the impact of PACS on radiologists’ workload and productivity (Gale, 1999), those that consider its clinical implications (Hertzberg, 2000) and those associated with performance of the radiology department (Hayt, 2001). Rather than measuring the quality of the PACS performance, other researchers have preferred to focus on the quality of the information, that the system produces, primarily in the form of images and reports. For instance, Lou et al. (1997) considered the data integrity and completeness of acquired images. Quality of images in terms of timeliness, accuracy, completeness, and so forth, was also considered to be a key success factor in several evaluative studies (Cox, 2002; Pavlicek, 1999; Pilling, 2003; Blado, 2002). Indeed, Cox’s work was part of a wider evaluation exercise undertaken to assess the impact of the introduction of a PACS on the adult intensive care unit (AICU) at the Royal Brompton NHS Trust in London. The objectives of the research were to evaluate the perceptions of PACS of the medical and ancillary staff working within AICU as well as to undertake a preliminary assessment of its impact on the workload of radiographers. Questionnaires, interviews and a process analysis were undertaken. The research findings indicate that the overall perception of staff towards the introduction of the PACS was positive. The impact of the system on the workload of radiographers was significant, reducing the time taken to obtain an image from 90 to 60 minutes. However, lessons to be learned for future PACS implementations include the need to ensure compatibility with existing IT systems and adequate IT support. In short, once this expanded, but rather fragmented view of PACS success is recognized, it is not surprising to find that there are so many different measures of PACS quality in the literature depending upon which aspect of PACS the researcher focused his or her attention.

Design of a Filmless Hospital

More rapidly than any technological advance in medical history, filmless hospital is changing the clinical and business aspects of radiology practice by delivering substantial cost savings, improved efficiency and quality, and greater access in an era of high demand and severely constrained resources. Systems are available in many variations, from mini-PACS to hospital-wide or enterprise-wide PACS. However, among the variations, the basic structure of a PACS is similar as shown in Figure 1.

Quality Control, Quality Assurance, and Business Continuity Plan in PACS

As PACS gains widespread use, the importance of Quality Control (QC), Quality Assurance (QA), and Business Continuity Plan (BCP) in PACS is rising. The purpose of QC/QA is to measure the quality and performance of a PACS for minimizing the chance of getting any avoidable risk. However, in the real world, there is still some risk in any complicated system. Therefore, BCP is used to reduce the impact and downtime of hospital PACS system operation due to changes or failures in the company operation procedure. The purpose of BCP is to make sure that the critical part of PACS system operation is not affected by critical failure or disaster.

Implementation of Information Security Management System (ISMS)

Fundamental to ISO 27000 (ISO/IEC 27001:2005, 2005) is the concept of an information security management system (ISMS). The information security management system (ISMS) is the part of the overall management system, which is based on a business risk approach, to establish, implement, operate, monitor, maintain, and improve information security. The management system includes organization, structure and policies, planning activities, responsibilities, practices, procedures, processes, and resources. For the management of information security, its scope, administration and resources will depend on the size of the healthcare organization and information resources in question. The ISMS should be effective if it is to be useful to the organization. Information security should be an integral part of the healthcare organization’s operating and business culture. Information security is primarily a management issue, rather than a technical issue, although one should not ignore the technical problems especially given the widespread dependence on the use of IT. Information security management is not a one-off exercise, but should be seen as an ongoing activity of continual improvement. Well-managed information security is a business enabler. No organization can operate successfully in today’s world without information security. A well chosen management system of controls for information security, properly implemented and used, will make a positive contribution to the success of the healthcare organization, not just a cost against the bottom line.