1 Data Management and Information Systems in Radiology

Roberto J. Rodrigues

July 2003

Senior Consultant, The Institute for Technical Cooperation in Health Inc. (INTECH), Potomac MD Vice-President, Medical Informatics Foundation, Miami FL Adjunct Faculty, Science, Technology, and International Affairs Program of the E. Walsh School of Foreign Service, Georgetown University, Washington DC Ex-Regional Advisor, Health Services Information Technology, PAHO/WHO

1. Overview: Information in Health and Healthcare
Information is a key resource and prerequisite for the effective provision and management of healthcare. The utilization of an appropriately designed and properly established data collection, processing, and communication systems with the objective of producing and disseminating management-oriented administrative and clinical information for operational support and decision making has been repeatedly shown to result in greater effectiveness and efficiency [1, 2, 3]. Information systems are critical for attaining the goals of improving access to equitable healthcare and the practice of evidence-based quality health interventions; for the achievement of cost-efficient operation and management of health services and health programs; and for the provision of individualized quality healthcare [4, 5] – indeed, the very quality of patient care and success in the very complex and competitive health sector is directly related to the reliability and timeliness of the information available to clinical practitioners and managers [3, 6]. Health information systems, to be useful, must allow for a wide variety and scope of clinical and administrative data. Health information is any and all information related to health – structured and non-structured data from patient records and files, with all that they may contain: time-based graphics; laboratory investigations; biomedical signals, e.g. electrocardiograms; X-ray, MRI, CT, ultrasound scan, and pathology images; bedside recordings of vital signs; and a large volume of coded and non-coded data originating from many providers and other professionals. In a broader sense, health information encompasses also other data sources: demographic data; information on social, cultural, economic, and environmental determinants of health; profiles on morbidity and disease specific mortality; findings resulting from clinical practice, biomedical, and epidemiological research; statistics on the activities of healthcare services, actions of health personnel, and coverage of health programs. At all levels of the health sector, the greatest need is the establishment of continuous information systems that enable the recovery of patient-oriented, problem-oriented, and procedure-oriented data to assist in the day-to-day operation of services, management of the logistics of care, and in the assessment of the impact of health services on the health status of individuals and populations. The variety of environments, priorities, organization, and operational demands of the healthcare sector require a variety of information and communication technologies and information system solutions capable of providing support for the challenging and complex interdependent clinical, public health, and managerial decisions and interventions that characterize health practice. Long used by the health sector as organization-facing “back-office applications such as enterprise resource planning, supply chain management, engineering applications and administration, logistics, and human resource management, health information systems have, accordingly, evolved to support patient-related “front-office” functions directly related to diagnosis and therapy [7].

2. Trends in Health Services Information and Communication Technologies
The imperative for information and communication technologies (ICT) in health is concrete, is driven by the operational requirements of patient care, organizational and resource management, and

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by the dictates of health reforms. Most of those health sector requirements are analogous to determinants found to be relevant in other service areas such as commerce, retailing, finance, transportation, and industry [8, 9, 10, 11, 12]: • Trend toward consolidation of the highly fragmented, expensive, and inefficient fee-forservice to models based on fixed revenue, e.g. capitation, forcing providers to search for ways to reduce costs, gain operational efficiencies, add complementary products, control induced demand, and streamline professional supply. In many countries, a significant percentage of healthcare expenditures are due to unnecessary costs mostly related to redundant tests and medical errors due to poor communication among providers. Health organizations and the form of healthcare delivery are undergoing a shift from an institution-centered to a citizen-centered model. The prime feature of the model is a new emphasis on continuity of services supporting health promotion and maintenance encompassing informed citizens caring for their health and an assortment of stakeholders responsible for the delivery of a continuum of health services within a region. Networks of producers, suppliers, customers, and clients and consolidation and partnering of stakeholders, physician practice management groups, group purchasing organizations, and integrated health delivery networks, linking outpatient facilities, diagnostic centers, hospitals, doctors, and patients have stimulated the reform of traditional health practice and management. Leasing, membership, service agreement, and strategic alliance models replace traditional business organizations based on ownership of physical assets and long-term structures. Lifetime value of customer retention replaces “one time sell”. Customization capable of achieving a “one of a kind” product or service and the possibility of instantly changing the products, prices, promotions, and other content to better meet user needs through economies of speed, demand forecasting, and customer service and satisfaction are becoming more important than economies of scale and impersonal service provision. Growth of a global marketplace and the ubiquity of interactive communications. Global demand for telehealth services is estimated to be of US$ 1,25 trillion, of which about twothirds is for direct services and the rest for second opinion, consumer information, continuing education, management and other services. Leveling effect of information and communication technologies which, by reducing entry barriers, allows small firms and poor countries and populations to have access to markets, information, and other resources, thus balancing the vertical integration competitive advantage of large corporations Availability of front office customer-facing applications such as Customer Relationship Management (CRM), Customer Interaction Software (CIS) as well as Customer Asset Management (CAM) with the goal of: identifying, attracting and retaining customers to generate profitable revenue growth; supporting the overall process of marketing and service provision; and the exploitation of provider and client information, data, and analyze patterns of activity among multiple organizational units for competitive differentiation. New back office applications including a wide variety of "company-facing" applications: financial management, accounting, inventory control, logistics, distribution, manufacturing, human resources, supply chain management, network systems, office tools (like word processors), and database systems. Even in this well-consolidated area there are emerging trends in response to increased competition among technological solution suppliers:

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partnering for technology and content; application outsourcing through an Application Service Provider (ASPs) model to host products off of client premises; web-enabled solutions that offer an easy and inexpensive way for clients to integrate their applications into existing computer facilities; development of affordable complete and highly integrated application suites; and the targeting of small and mid-sized companies by delivering packaged hardware, software, and services to meet the business requirements of small and mid-sized organizations which helps smaller companies keep their costs down by eliminating the need to do business with different vendors for hardware, software and services.

3. Hospital Information Systems (HIS)
The objective of a hospital information system (HIS) is to use computers and communications equipment to collect, store, process, retrieve, and communicate patient care and administrative information for all hospital-related activities and satisfy the functional requirements of all authorized users. Modern HIS products have the capability of managing integrated multi-facility medical communication and the storage and retrieval of all patient data during the current and previous contacts with the healthcare system [13]. Clinical information systems are evolving in the direction of a “lifetime” electronic health record capable of storing all significant personal health data. To attain those goals, a number of functional objectives must be achieved: • Establishment of a database capable of providing and integrated and continuous computerstored medical record for all relevant patient data and make it directly accessible to all authorized health professionals at all times (“24 hours a day, 7 days a week”). Communication of patient clinical and administrative data to and from all hospitals services and between different hospitals. Support of all health provider functions, including order entry, results reporting, consultations, and procedures. Provide clinical and administrative evidence-based decision support. Have functions capable of supporting logistic and business functions such as eligibility, registration, scheduling, accounting and billing, personnel, materials management, and financial administration. Assist with quality assurance, accreditation, and regulatory requirements. Support research, education, and training requirements.

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4. Radiology Information System (RIS)
The rationale for the establishment of a RIS depends greatly on the size and type of practice, degree of specialization required, and economic determinants. For the clinician user, a RIS means timely accessibility to reports and the concurrent access to various types of imaging studies, many done in different diagnostic units. The addition of telecommunication links reduces the lag time associated with sending studies by mail or courier from small clinics to an off-site radiologist for interpretation and, conversely, reports, films, and other studies once interpreted can be made immediately available to remote users. For the radiologist, a RIS eliminate redundant entry of patient data, allows the reception of requests electronically, automates image display and storage, facilitates the recovery of previous exams for comparison, assists the implementation of standardized reports and digital signature, and allows the integration of voice processing through digital dictation [14, 15]. A RIS that incorporates a

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full-feature picture archiving and communication systems (PACS) fundamentally changes the nature of radiology practice and reporting. Technology solutions allow the creation of a multimedia document consisting of a selected image or a series of images, text of result, supplemented by an animated pointer or drawing tool to highlight significant findings at the same time that the radiologist’s spoken interpretation is played [14, 16]. For the patient, the benefits of a RIS relate to better control of exams and results by reducing the chances of loss or misplacement of images and unnecessary repeat examinations with attendant cost, radiation exposure and patient inconvenience, and faster reporting and delivery of the right images to the right user at the right time [17, 18]. If the RIS is integrated to a computerized hospital or clinical information system one can easily have imaging studies displayed with simultaneous access to clinical information. To the manager of a radiology service, the logistical support provided by a RIS allows flexible and effective scheduling and booking, the administration of queues, precise documentation and accurate statistics, higher quality and quicker response time in the transcription process, automatic electronic transmission of reports, exchange of exam and report data with the HIS or payers (insurance, third-parties) for billing purposes and for statistical data gathering and management reporting, and improved tracking of documentation and hard copies of image studies that are taken out from the service archive. The purchase and implementation of a RIS must be seen as the first building block before the acquisition of a PACS.

5. Generation and Communication of Digital Images
Digital imaging and its impact on the processing and distribution of imaging studies are major issues both from the logistical and economic perspective. A large number of diagnostic equipment such as MRI, CT, and ultrasound scanners, and nuclear medicine gamma cameras primarily generate digital outputs. More recently, the advent of computerized radiography (CR/DR) has added a new incentive to transition to electronic image management. This has motivated many radiology departments to convert to filmless or almost filmless operation. Image digitizers (scanners) are used to transform film-based images from non-digital radiology equipment to digital format. Digital images are arrays of discrete data elements represented in a matrix in which the smallest component is called a picture element or pixel. To each pixel a numerical value can be assigned by a computer systems representing gradations on a grayscale or colors of a palette. The number of pixels necessary to convey the information in a image depends on the size of the image, for instance, a matrix of 2,048 by 2,048 pixels may be required to record black and white data from a chest radiography1. For storage and to reduce transmission time, images can be compressed. Compression reduces the size and cost of mass storage devices (hard drive arrays, optical media) and allows fast file loading and display and facilitates distribution over telecommunication networks, particularly through public networks (Internet)– the most used model is the JPEG (Joint Photographic Expert Group) standard [19]. Digital imaging and communication standards are essential and presently well established. In 1983 the American College of Radiology in collaboration with the National Electronics Manufacturers
If coded at 16 bits a 2,048 x 2,048 pixel matrix requires 8.3 million bytes of data or 8.3 Mbytes for storage. A single CT or MRI scanner study requires 12 to 25 Mbytes and a CT machine may easily produce many Gigabytes (1 GByte = 1 x 109 bytes) in a relatively short time span while a fully digital radiology service will generate several Terabytes (1 TByte = 1 x 1012 bytes) of data in a year. It is clear that storage and retrieval of this volume of data is one of the core issues in the design and implementation of a system to process and archive images. It is the number of bytes of an image study, commonly referred as the “size” of the image, expressed in Kylobytes or Megabytes, that determines the level of resolution or granularity of the image and the time that will take to transmit the image as a file without compression through a communication channels.
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Association (NEMA) created and published standards that evolved to become the Digital Imaging and Communication in Medicine (DICOM) version 3.0 standard adopted in 1993 which, besides imaging, includes a variety of definitions and communication standards for the whole medical field -- DICOM specifies a generic digital format and a transfer protocol for biomedical images and image-related information such as the network environment including physical components and protocols; image handling standards; data transfer and processing (distribution, display, printing) standards; objects that include images, reports, lists, measurements, coding tables; and integration standards for information objects allowing systems intercommunication. Even though the DICOM Standard has the potential to facilitate implementations of PACS solutions, it does not, by itself, guarantee interoperability of PACS components 2.

6. Picture Archiving and Communication System (PACS)
PACS is a combination of hardware and software that digitally stores and manages medical images and information and there has been an accelerated adoption of digital equipment and implementation of PACS. By using PACS, medical professionals can quickly and efficiently access radiological images. Unlike older film-only systems, multiple users, even those in different remote facilities, can view images simultaneously. PACS can interface with other clinical systems to access the patient medical record and other clinical, diagnostic, and administrative data and make these available along with images to provide an integrated diagnostic perspective. The heart of a PACS is a computer server that provides control and routing of digital information. Because medical image files are typically very large, the server has to manage the storage and archiving of information as well as the routing. The server is also responsible for the bidirectional communication with the HIS and RIS and image distribution to provide medical professionals with all elements for an evidence-based and timely diagnosis. There are two general categories of output devices used with a PACS: workstations (diagnostic and review) and laser printers. PACS components communicate through electronic networks and may use a Local Area Network (LAN) within a health facility or nearby facilities, a Wide Area Network (WAN) between distant facilities, or a Public Network (Internet). The network provides the physical means by which the various components exchange information and the data communication device and type of link (dial-up, dedicated line, local cabling or fiberoptic, etc.) will determine the transmission characteristics. For the PACS/Internet distribution system to access patient data and be able to associate it with image records, we need to add a computer that can communicate with both systems through a HIS/RIS gateway.

The DICOM specification is usable on any type of computer and interfaces are available for nearly all types of imaging devices. It has been adopted for use in pathology, internal medicine, veterinary medicine, and dentistry. In 1995 and 1997 new additions were made to the standard to incorporate teleradiology requirements and linkages to SNOMED (Systematized Nomenclature of Human and Veterinary Medicine) and LOINC (Logical Observation Identifiers, Names, and Codes) coding structures. DICOM also has a close relationship with the Health Level 7 (HL-7) standard and internationally it is compatible with the CEN/TC 251 WG4 MEDICOM standard of the European Union and the JIRA and MEDIS-DC of Japan [1, 14]. A few years ago, the IHE (Integrating the Healthcare Enterprise) initiative was undertaken. The IHE initiative is a project designed to advance the state of data integration in healthcare. Sponsored by the Radiological Society of North America (RSNA) and the Healthcare Information and Management Systems Society (HIMSS), it brings together medical professionals and the healthcare information and imaging systems industry to agree upon, document and demonstrate standards-based methods of sharing information in support of optimal patient care. It is important to ask potential vendors of PACS components and other information systems of their participation in the IHE initiative.

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July 2003

A fully integrated RIS/PACS solution offers the most promise for advanced image and information management. With the RIS as the primary manager of information between RIS and PACS, one can handle almost any imaging environment. When multiple imaging environments are part of the institution, the ability to use the RIS system for management is particularly advantageous and attractive. The core of a RIS/PACS product is a server and its electronic archive (Figure 1).

FILM PROCESSOR

DIGITIZING STATION

HARD COPY ARCHIVE

RIS/PACS SERVER & ARCHIVE PRINTER REMOTE USER

IMAGING WORKSTATION

WEB CT SCANNER MRI SCANNER CT/MRI CONSOLE

WEB SERVER

ULTRASOUND GAMMA CAMERA HIS SERVER DIGITAL RADIOLOGY SYSTEM DIAGNOSTIC WORKSTATION

PRINTERS

HIS TERMINAL

RIS/HIS GATEWAY

Figure 1. Components of a RIS/PACS System Linked Through a Local Area Network (from Kodak™ PACS/Web Distribution System Concepts Course, modified)

The image server and archives provide access to images and related information to any part of the network, locally or remotely, and through appropriate gateways support the connectivity with other internal and external networks and information systems. Speed and safety are as important as the effective use of hardware and manpower. Hard disk technology has evolved considerably and supports inexpensive storage and fast access to images. For long-term storage, other devices can be used, if desired, but online short-term and long-term storage on hard disk is more and more becoming the solution of choice. Workflow demands for a specific service need to be carefully assessed and analyzed and ideally one should aim for a seamless automated workflow. To define detailed user requirements and specify systems is a laborious process. It is particularly difficult to establish what is needed to synchronize patient relevant data avoiding duplication of data entries and having a system that operates within a consistent patient data set in a bi-directional way between the RIS and other clinical and administrative applications (Figure 2). There are three categories of RIS vendors: (a) Single-source vendors - offer all the different healthcare information systems including hospital information systems (HIS), laboratory information systems (LIS), radiology information systems (RIS), pharmacy systems, etc.; (b) Multi-product vendors - offer more than one product but not a complete product line like the single-source vendors. While it is true that every single-source vendor is a multi-product vendor, not every multi-product

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vendor is a single-source vendor; and (c) Single-product vendors- offer a single product such as an RIS and no other products. The vendor category selected will greatly influence the capabilities and overall functionality of the RIS system one gets.

report

report
Registration report Report Repository Diagnostic Workstation Film Lightbox

patient information

images retrieved

Orders Placed

examination orders
Orders Filled

procedure scheduled Image Manager Prefetch any relevant & Archive prior studies Acquisition modality images Modality worklist stored acquisition completed acquisition images completed in-progress inprinted

Film

Figure 2. Typical HIS/RIS/PACS Workflow [20]

Within the category of single-source vendors there are those that developed all the software themselves and therefore offer integration and there are those that did not develop all the software and, therefore, must rely on interfaces. Because of the frequent confusion among buyers of the meaning of the terms “interfaced” and “integrated”, it is not uncommon for single-source vendors, who offer an interfaced product line, to pass themselves off as integrated. A single-source vendor may have written their own hospital information system and laboratory information system but acquired a radiology information system and a pharmacy information system from third parties in order to complete their product portfolio offering. But just because one can purchase all products from a single vendor it does not mean that the products are actually integrated. Multi-product vendors, like single-source vendors, may have developed their software or may have acquired some or all of their software from other sources. Since multi-product vendors don't offer a total solution, they must rely, at least in part, on interfaces. Multi-product vendors, including single-source vendors, typically have one or more strong products that drive the company, as well as one or more products that aren't as strong. For example, they may offer a strong HIS, an average laboratory information system (LIS) and a limited RIS. The reason for this is that vendors supporting multiple products are going to put efforts into the products that have the greatest potential to generate revenue. The other systems may not receive this preferred status and can therefore remain static for extended periods of time. Most best-of-breed vendors fall under the single-product category because they can devote all their attention to only one product. By focusing total energy and attention on a single product, it is possible for a single-product vendor to offer a RIS product that is superior when compared to other RIS products and, by definition, best-of-breed relies on decentralization. If so, why would a hospital or

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clinic select anything but a best-of-breed vendor? Best-of-breed will definitely provide the best combination of products, but, facilities striving for centralization and integration prefer the control of keeping everything together even if they sacrifice some features and or functionality. So, to the buyer, the question comes down to maximum control versus maximum capabilities. Radiology managers usually prefer maximum capabilities while the information systems department usually prefers maximum control. Therefore, facilities with strong information systems departments generally prefer to purchase a RIS from a single-source vendor. Conversely, facilities with limited or non-existent information systems departments generally prefer to purchase their RIS from a best-of-breed vendor 3 .

8. Electronic Networks and Teleradiology
Radiology is the ideal clinical service for telehealth. Radiology was one of the first medical specialties to embrace telecommunications for the transmission of images from and to remote locations. The majority of imaging studies are standard diagnostic procedures performed in a standardized manner and reported in a “production line” process and in the majority of cases, the radiologist is not constrained by appointment time and does not have to be present when the procedure is performed except for a small number of diagnostic studies such as image-guided biopsies and contrasted procedures. Patient clinical information and the reason for conducting the investigation are present in request forms or, if an electronic patient record exists, can be directly accessed. From the organizational viewpoint, many small clinical care facilities have no specialized procedures done, most of the work is routine chest, abdomen, and bone studies, yet they require the presence on an on-site radiologist solely to interpret and report on those rather standard procedures and online radiology groups can provide patients and referring physicians with a 24x7 access to state-of-the-art diagnostic interpretation regardless of location [21, 22, 23, 24, 25, 26].

9. Integrating Health Facilities and Services
The advent of client/server computing, more sophisticated digital image compression technologies, improved computer network technologies, DICOM and HL-7 protocols, and integration between radiology information systems (RIS), picture archiving and communications systems (PACS)
Independent of the product and vendor option, there are common features that must be present: a user-friendly system interface, high flexibility, quality, and safety as well as integration between the RIS/PACS and the HIS and other information systems. Web technology promises users cost effectiveness. A broad range of functionalities must exist: streamlined registration, scheduling, patient tracking, film and electronic image management, transcription, historical index, multiresource scheduling, department monitoring, supply control, word processing, digital dictation (and voice to text) and a wide array of user-defined management reports. Patient tracking must support adding, canceling, modifying, or providing reasons for repeating a procedure. At the same time, it must allow for the capture of service activity, resource utilization, supplies used, reactions, technical factors, and quality assurance information. To ensure that images and patient data are tied together the system must automatically update the RIS for tracking functions, eliminating technologist intervention. The system must strive to achieve as much as possible a paperless workflow through worklists and messaging allowing technologists to provide efficient, quality patient care and permitting technologists, radiologists and clinicians to effectively communicate the progress of a patient's exam without disturbing their workflow. Film management functions provide comprehensive borrower information and track film movement among departments (and location of digital images, if on other storage medium), hospitals, and outside facilities tracking and displaying a patient's folder, subfolders, and procedure. The system must provide for audit trails, purge lists, overdue and return file notices, file reservations, and the automatic printing of bar coded jacket labels and pull lists. Image viewing and routing will route critical images from film management to anywhere in the enterprise. Management reporting management eases reporting efforts by enabling administrators to efficiently receive comprehensive reports that help them make critical decisions. Web-based radiology results can make critical healthcare information available anytime, anywhere.
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and clinical and administrative systems (ex.: HIS) have all combined to bring the realization of enterprise-wide radiology information management within reach. Health care information, especially high-volume image data used for diagnostic purposes -e.g., X-ray CT, MRI, and digital angiography -- is increasingly collected at tertiary (centralized) facilities, and may now be routinely stored and used at locations other than the point of collection. Diagnostic and image data being generated at different facilities while the images, or other large data objects they produce, need to be used from a variety of other locations such as doctor's offices or local hospitals. The use of a highly distributed computing and storage architecture to provide all aspects of collecting, storing, analyzing, and accessing such large data-objects through network interfaces between the object sources, the data management system, and the user of the data is of great practical interest. The importance of distributed storage is that it is technically feasible to maintain a large-scale digital storage system, and an affordable, easily accessible, high-bandwidth network can provide location independence for such storage. The importance of remote end-user access is that the health care professionals at any care facility, frequently remote from the tertiary imaging facility, will have ready access to not only the image analyst's reports, but the original image data itself. As the data is being stored, a cataloguing system automatically creates and stores condensed versions of the data, textual metadata and pointers to the original data. The user is able the view the low-resolution data with a standard Internet connection and Web browser. If high-resolution is required, a high-speed connection and special application programs can be used to view the high-resolution original data [27].

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