With the proliferation of picture archiving and communications systems (PACS) throughout the United States health care system, there is an immense need for alternative approaches to maintenance and quality control (QC) support of PACS systems. One method of cost reduction is through the implementation of enterprise maintenance programs. While many PACS vendors are willing to negotiate various forms of shared service arrangements, multi-facility and enterprise-wide negotiations are rarely implemented. This paper will present such an approach by describing a four-step process: (1) identify maintenance and QC tasks across the entire enterprise; (2) identify maintenance and QC resources within the enterprise that can be assigned against those tasks; (3) identify vendor-unique resources that must be added to complement enterprise resources; and (4) negotiate with all member sites of the enterprise and the vendors for the assignment of resources against all maintenance and QC tasks. Additionally, these steps can be balanced through identification of the principal trade-offs tied to resourcing, namely: quality, speed, and cost. If this approach is implemented, it presents a mechanism for achieving maintenance service cost reductions, while supporting clinical operations, through the benefits of economies of scale, collective bargaining, and use of existing resources.
Goals of program
The major goal of an enterprise maintenance plan is to optimize clinical efficacy and operational cost through the blended application of local, enterprise, and vendor resources. The medical goal of this enterprise warranty and maintenance management plan is to maintain all clinical sites at an acceptable standard of care in this changing clinical business environment. These goals can be accomplished, in part, by supporting the following practices:
- Maintain high-quality medical image acquisition and digital transfer processes
- Maximize efficient utilization of all possible PACS maintenance and QC resources
- Maintain timely and high-fidelity data communications with required upstream and downstream information systems
- Maintain safe archival and effective distribution of all PACS data
- Maintain display calibration standards across all display devices
- Maintain high availability of PACS to ensure that users have access to PACS data when needed
- Maintain an effective training program for all PACS users, maintainers, and QC staff
- Establish and maintain fixed relationships between maintenance, QC, and quality assurance (QA) operations
Maintenance Program Description
The enterprise maintenance program is a set of equipment performance criteria and management practices that tracks and administers the progress of maintenance and QC activities on PACS equipment and related imaging and information systems. Maintenance and QC services should be managed on a site-by-site basis utilizing vendor maintenance to augment in-house capabilities only as required. Each individual site should be established as a stand-alone clinical activity on a local clinical requirements basis, in order to ensure that local clinical capabilities are continuously supported and not lost in the enterprise view of requirements. Maintenance and QC resources, on the other hand, can be applied across the enterprise in a shared manner as long as all local maintenance and QC tasks are supported adequately. Additionally, enterprise maintenance and QC tasks can be negotiated between the enterprise and the vendors as a new level of shared maintenance. At this level, collective bargaining comes into play, wherein the enterprise offers additional resources beyond those that are normally negotiated as part of any individual hospital or facility.
|Figure 1. A visualization of the Acceptance Testing/Quality Control/Warranty and Maintinance continuum|
The Maintenance Program Manager. The enterprise concept of maintenance, QC, and QA would establish an enterprise maintenance program manager who would maintain the contract for enterprise maintenance covering all sites, and monitor the performance of the overall program. The enterprise maintenance program manager, with feedback from local maintenance and QC and QA managers, would be the enterprise representative to evaluate program effectiveness and efficiency considering both in-house and contracted tasks. The program manager is also responsible for facilitating required adjustments to the program to maximize efficiency and effectiveness.
The Warranty, Maintenance, QA, QC Continuum. In many PACS implementations, gaps form between the various functional areas of radiology operations, informatics, and clinical activities due to confusion about the status of the old relationships and confusion about what new relationships must be formed. In fact, there is a general increase in the need for management of these relationships due to the drastic changes that take place during PACS implementation. More specifically, maintenance and monitoring of the functional relationship between PACS, imaging equipment, information systems, network operations, and human activities require more controls during PACS implementation and not less. Because of this, a PACS maintenance program should have a program scope that establishes overlapping responsibilities of warranty, maintenance, QA, and QC operations for all functions that PACS has any relationship with. This proactive approach is needed to revitalize the concept that highly effective clinical services are maintained by highly effective support services. This approach to increased maintenance program scope creates a continuum of monitoring and support operations for the entire spectrum of activities affecting PACS efficacy, and brings into play the expertise of several enterprise and local hospital staff elements as well as supporting vendors and service providers.
It is important to introduce the continuum concept of operations as soon as PACS begins to be implemented. This prevents gaps in service and bad habits from forming due to a lack of guidance or understanding. All levels of the enterprise need to be trained in the relationships involved in the continuum. The worst thing that can happen is to introduce chaos into the clinical scenario due to a lack of understanding of the linkage between steps in the delivery of radiology services in a PACS environment. Chaos exhibits itself in several ways: nondiagnostic images, time-consuming delivery processes, wasted manpower, user frustration, rising film costs in a “filmless environment,” frequent service calls to vendors, continuous reconfiguration of system interfaces, misfiling of digital images in the PACS, reduction in the standard of care, and increased medical-legal risk, to mention just a few.
The Warranty, Maintenance, QA, QC Continuum is planned while the PACS is in procurement, begins when the PACS gets accepted, and continues as long as the PACS system is under warranty, through the life cycle of the system and the replacement of the original PACS with its successor. The continuum is not for the PACS; it is for the enterprise. It is the reestablishment of a total QA program for a rapidly changing environment. PACS does not change the overall process of radiology service, just how parts of the process are connected. It still starts and ends with the patient and primary physician requiring ancillary service support in the form of imagery and radiological reports. Quality issues remain at each step in the process, just as they did in the film-based environment. The difficult thing to deal with is that QA and QC and maintenance are now interrelated as never before. Inadequate training, machine hardware and software problems, data entry errors, networking problems, and equipment misconfiguration problems lead not only to poor image quality but also to missing or incorrect data, misfiled images, missed delivery schedules to the physician, and, ultimately, failure to meet the clinical expectations of the patient. They also are invariably the cause of the most frequent complaint, no matter what the actual source: “The PACS is down.”
The diagram below depicts the relationship between warranty, maintenance, and QC activities over the life of a PACS. As you can see, the standards for proper operations are established upon acceptance testing and continue during the warranty period and through the life of the system.? As time goes on, there should be no change in quality or efficiency expectations from the PACS or related equipment and systems without an adjustment of the maintenance program and associated QA/QC standards and practices. Additionally, the relationship between maintenance and QC resources is pointed out in a cyclical process that repeats whenever a quality issue arises either from a failure of a scheduled quality check or from a reported PACS equipment failure. Note that the maintenance resources required to respond to any given quality failure is not specified in the diagram. It could be a local in-house maintenance person, an enterprise maintenance person, or a contracted vendor. The type of maintenance resource applied to any given maintenance task depends on several factors, which are the subject of a later paragraph.
Warranty, Maintenance Services
PACS combine large core computer operations with clinical software and hardware operations. Together with the hospital network, diagnostic workstations, and clinical review and desktop workstations, PACS provides the connective tissue, final display media, and tool sets for the delivery of medical imagery and related data to the clinical population. PACS provides a direct link between the diagnostic data produced by imaging modalities and the upstream clinical information systems (hospital information system and radiology information system [RIS]) to the clinical users. As such, PACS are governed by the rules for biomedical equipment as well as computer information systems. The most stringent set of rules for managing services to the PACS is through the biomedical equipment management process that is in place in the biomedical maintenance branches of all health care facilities. Biomedical maintenance, also referred to as clinical engineering, uses “clinical capability” as the driver of their services and policies. The need to maintain clinical capabilities requires clinical engineering departments to have faster response times and repair and replacement policies than the information systems (IS)/information technology (IT) division typically has for network and desktop computer equipment. This program of heightened response and restoration capabilities is needed as the PACS is the delivery device of critical imagery and data throughout the facility. A successful PACS maintenance program must be driven by priorities and schedules like those of a clinical engineering department.
High Level Support for PACS Warranty and Maintenance Management. It is broadly recognized that digital imaging and PACS are enabling technologies for business process reengineering (BPR), which has cost management, radiological efficiency, and clinical efficacy as major goals. The administrative management of enterprise PACS systems should, therefore, be placed under the enterprise level management point that has functional responsibilities and control over these areas. In the typical multi-facility hospital, this management control point would be the COO or CIO level, with a vice president directly tasked with the responsibility for overseeing PACS operations and resources in support of enterprise goals. Below this level of responsibility, it is typical to have a mix of functional management points depending on the internal operations of each enterprise. Radiology, information systems, or clinical engineering can be assigned direct ownership of and responsibility for PACS as long as the others are directly assigned to contribute required resources for successful PACS operations. The department assigned direct ownership and functional responsibility will be the principal in negotiating the procurement and maintenance, keeping records, and managing the maintenance program. Other supporting departments should answer to the PACS owner in terms of their support contribution.
The Enterprise View
The movement to enterprise management of PACS brings with it the requirement to report cost management data to an enterprise control group. Additionally, the enterprise use of PACS will include
teleradiology, along with wide area networking (WAN) and metropolitan area networking? (MAN), which interrelate the PACS operations of all health care facilities. A maintenance management plan that unifies the requirements and management structure for the PACS across the enterprise should focus on overall cost and quality of service issues. Hospitals negotiating warranty and maintenance issues with a PACS vendor will be more effective if they have an enterprise plan and an experienced negotiator on their side along with the power and insight to address communications, networking, maintenance, and QC operations as part of the PACS procurement and maintenance negotiations. Basically, the bigger the game, the deeper the discounts. More participating hospitals means more volume discounts on PACS purchases, and more in-house skills and resources brought into the maintenance and operations plan reduce the life-cycle costs.
The enterprise view of PACS procurement and operations can work only if there is follow-through on the plan. A reduction of in-house resources needed to support continuous PACS operations without the appropriate funding for contractor support in those areas will have a disastrous effect on the entire enterprise as it relies on quality PACS services.
Maintenance Resources. The environment in which PACS warranty and maintenance operations will be conducted is similar in most hospitals. There are clinical operations with departments such as radiology, orthopedics, emergency medicine, and surgery. There are also administrative operations, with organizations such as information management, biomedical maintenance, and facilities management. PACS systems are relatively new to the hospital environment and require the combined use and support of both clinical and administrative elements of the hospitals. Several resources available within hospitals and the health care enterprise are listed in the following paragraphs. Most exist in hospitals but often do not have the breadth of experience to support PACS operations.
1. Clinical Resources. Radiology departments are the primary users of PACS systems and must perform and maintain operations in support of clinical image quality, data quality control, and clinical process management. Radiology staff typically will be looked at as the “super users” who can provide minor problem resolution.
PACS components are also distributed throughout the medical treatment facilities of the enterprise. Clinical users of the system should be held responsible for performing operator level tasks such as cleaning equipment, performing user QC checks, and placing service calls for malfunctioning equipment. A point of contact (POC) from each clinical department using the PACS should also be appointed and the “super user” should be responsible for addressing clinical user maintenance issues before passing them on to radiology or any other maintenance organization.
2. Technical Administration Resources. Management of warranty and maintenance issues for PACS operations requires activities from the hospital’s technical administrative resources. Purchasing and contracting must administer clear and focused procurement and maintenance contracts. Logistics staff must maintain the proper equipment inventories and ownership documentation for the PACS equipment.
3. PACS Vendor Services. The PACS vendor is the ultimate source for warranty and maintenance services. For a price, the vendor can provide many of the requirements for PACS operation and support. What PACS vendors are not usually prepared or willing to take on is the responsibility for the efficient and effective results of PACS operations. Any desired association with a PACS vendor, including responsibility for filmless operations, clinical business practice change, and enterprise goal achievement, will need to be keenly worded in order to keep the vendor as involved as the hospital and enterprise will be. This is because there are too many factors outside of the control of the PACS vendor to allow them to effectively make a change happen in the clinical environment. What they do have control over is the installation, configuration, calibration and maintenance, and training of the system they sell. Therefore, warranty and maintenance terms and expectations should be clearly spelled out in the purchase contract and instructions for following maintenance contracts and any associated costs should be clearly delineated.
4. In-House Maintenance Services. Most hospitals have a common structure in that they all have some in-house resources for support of facilities, utilities, biomedical equipment, office automation, networking, and communications systems. These service organizations usually also have the responsibility to oversee those services when contractors provide them.
The implementation of a PACS system in a hospital requires close coordination between the information systems division, biomedical maintenance branch, and radiology department. Each contributes to the overall quality of the PACS system performance. Each has a unique set of skills and responsibilities to contribute to the maintenance program.
5. Information Systems Division, Information Technology Division. The information systems division of each hospital is the logical manager of large computer systems that support multiple using divisions and facilities, as does the PACS. IS/IT is the likely candidate to take on the responsibility of managing operations of the central computer room components, network operations, and system administration operations of the PACS. Often the data and work flow being managed in RIS and PACS is beyond the knowledge base of IS/IT computer operators, and so they rely on the radiology department to provide a system administrator who manages the data input and output of the RIS and PACS while the computer operators manage the more common tasks such as backing up the systems, performing cleaning and printing jobs, monitoring error logs and alarm indicators, and maintaining the computer room itself.
6. Clinical Engineering and Medical Physics. The clinical engineering division and medical physics section of each hospital or enterprise should be responsible for monitoring the warranty and maintenance contract of PACS operations at all facilities and either taking corrective actions or reporting discrepancies to the PACS program manager at the enterprise level. PACS systems are FDA-approved systems that require calibration, preventive maintenance, and electrical safety testing, as do any other medical equipment systems. The fact that they have a large computer server operating in a computer room does not change the fact that they are diagnostic medical systems. Testing of image quality from the point of acquisition to the point of display is also the responsibility of medical physics or clinical engineering as part of the PACS QC process. n
NOTE: Part II, Building a Task Allocation Chart, will appear in the June issue.
- Norton GS, Romlein J, Lyche DK, Richardson RR. The task allocation chart: quality control of a picture archive and communication system (PACS). In: Blaine G, Horii SC, eds. Medical Imaging 1999: PACS Design and Evaluation: Engineering and Clinical Issues. SPIE Proceedings. 1999;3662:409413.
- Romlein J. Reality check: QC in the digital department. Decisions in Axis Imaging News. 2002;15(5):18-24.
- Romlein J, Norton GS, Lyche DK, Richardson RR. PACS: acceptance test, quality control, warranty, and maintenance continuum. In: Blaine G, Horii SC, eds. Medical Imaging 1999: PACS Design and Evaluation: Engineering and Clinical Issues. SPIE Proceedings. 1999;3662:111119.
- Staley SD, Romlein JR, Chacko AK, Radvany M. Regional maintenance approach for PACS within the healthcare enterprise. In: Blaine GJ, Siegel EL, eds. Medical Imaging 2000: PACS Design and Evaluation: Engineering and Clinical Issues. SPIE Proceedings. 2000;3980:437-446.
John Romlein is vice president, Xtria Healthcare Digital Solutions, Frederick, Md.
John Weiser, PhD, is chief scientist, Xtria Healthcare Digital Solutions, Frederick, Md.