Laboratory Information Management Systems in Resource-Limited Environments

Transcription

1 Laboratory Information Management Systems in Resource-Limited Environments Robert Martin, MPH, Dr.PH Ralph Timperi Ramesh Krishnamurthy Ph.D., MPH Summary Electronic laboratory information management systems (LIMS) have become key components of clinical and public health laboratory infrastructure in developed countries. These systems perform a variety of functions, from ordering tests to documenting the collection of specimens to reporting results to health care providers and to public health programs. Early LIMS were oriented to the business practices of laboratories, but have evolved into a key component of assuring the quality of testing. As health management information systems (HMIS) are developed and as they mature, laboratory data are viewed as key elements of health records. With appropriate integration of surveillance data, LIMS can be utilized (with safeguards to assure appropriate use) by public health systems to monitor disease conditions (chronic as well as infectious diseases) and to evaluate program efficacy. Therefore, LIMS should not be developed as stand-alone vertical systems that focus only on the testing process, but instead, they should be designed to function as integral components of a national health-information system. In resource-limited settings, laboratory data are largely managed by paper-based systems for single-purpose use of data. Electronic LIMS are at the earliest stages of development. However, increasingly, laboratories in many countries are viewed as obvious candidates for implementing information and communication technology (ICT) for better public health outcomes. The need for effective LIMS is increasingly being recognized as important for improving diagnosis, treatment, care, and support for people living with infectious diseases. While there is this perceived need by countries and by international organizations and while there have been guidance documents developed and standards addressed there are many barriers to introduction in resource-limited settings. LIMS that are developed by incorporating best practices of health metrics and standards will strengthen larger public health systems and will help assure the use of those data for better public health outcomes. Introduction A well-designed health management information system, constituting reliable, accurate, and timely availability of data, is widely recognized as a cornerstone of a good public health system. A laboratory information management system (LIMS), developed as part of the national HMIS in a public health setting can support a variety of programs and functions including epidemiology surveillance and monitoring, outcomes assessment, administrative activities (e.g., billing and utilization), program planning and evaluation, quality assurance, policy analysis, research, and information dissemination. 1 Increasingly, many nations are adopting integrated disease surveillance and reporting processes to improve public health outcomes. Laboratory information systems have been considered as crucial in this integrated approach to data flow between diagnostic facilities at the district level for outbreak-prone diseases. In the United States, LIMS were first implemented in clinical/hospital environments to address both business needs and to assure prompt delivery of results to health 1

2 care providers. Through computerized data entry, access, and retrieval of reliable laboratory data, LIMS also addressed important issues inherent in the laboratory including accessioning of specimens, sample tracking, the creation of work lists and test scheduling, quality-assurance activities (e.g., equipment maintenance), automated interfaces to laboratory equipment, the generation of aggregate reports, and the automated delivery of patient reports. The development and application of information systems for public health laboratories lagged behind the clinical patient-care environment. However, the necessity of LIMS for public health laboratories soon became apparent due to the aforementioned reasons but more recently due to the need to make accurate data available to provide timely response to both human-induced as well as naturally occurring public health threats and emergencies. As noted earlier, in the U.S. LIMS development in clinical and public health settings developed independently because of the separation of public health from patient care. However, in most countries laboratory services for both public health and health care often take place in the same physical setting. Therefore, although there are valuable lessons to be learned from the development of LIMS in the U.S., the challenges facing the development of LIMS in resourcelimited countries must take into account the needs of both individual patient care as well as the needs of public health programs. The architects of LIMS have long recognized the challenges faced and gaps in the flow of data from laboratories within and between various national health sectors using information and communication technology (ICT) tools. While there are often adequate resources at the state/provincial laboratories and regional laboratories and at some institutes where there are disease-focused reference laboratories inadequate ICT support at the peripheral laboratories and microscopy centers and at district health laboratories continues to pose challenges to creating the timely and bidirectional flow of laboratory data. As numerous vertical systems were developed to address various components of national public health information systems, it also became apparent that networking of systems would provide both timely and reliable information for public health action. In order to assure that information from various sources could be analyzed in aggregate, it was recognized early on that attention to standards for messaging (Health Level 7), vocabulary (Systematized Nomenclature of Medicine (SNOMED)/Logical Observation Identifiers, Names, and Codes (LOINC)), database structure, and record elements are important considerations. Incorporation of metrics and standards led to better data management. As noted earlier, the implementation of laboratory-information systems in developed countries first occurred in the clinical-laboratory environment. Public health laboratories either developed their own non-standard systems using in-house IT staff, or purchased proprietary products that were oriented towards the clinical laboratory and then customized for public health needs. Both approaches had advantages and disadvantages, but increasingly the need for information systems in public health laboratories has resulted in the availability of more proprietary products. Currently, the situation for international laboratories in resource-limited settings is similar; that is, laboratories are faced with developing their own systems using tools such as Microsoft Access databases or Epi-Info but often without attention to standards for vocabulary and messaging. Some laboratories are working with vendors whose primary product is focused on the clinical laboratory and modified to address public health laboratory needs. An open-source product used by six Association of Public Health Laboratories (APHL) member state laboratories is also under consideration in Vietnam and Kenya and may provide alternatives to in-house development or vendor-supported software using open-source approaches. Developing a reliable LIMS is a complex undertaking but when implemented utilizing best informatics practices, the system can yield valuable and timely results for public health action. Drivers for Implementing LIMS in Resource Limited Settings The primary drivers for development of LIMS in developed countries were associated with business (e.g., billing) and customer (e.g., health care provider) needs. In the public health laboratory, the drivers were primarily associated with customer (e.g., program) needs although the same benefits associated with quality assurance were available as well. In resource-limited settings, the public health and health care needs are often met at the same point; that is, clinical care is provided at health centers and district hospitals where patient testing is performed and public health testing is often performed in the same environment. As a result, the LIMS required in these settings must meet the needs of both clinical care and public health. 2

3 Although the issues mentioned above are major drivers in resource-limited settings, an important additional driver is the development of International Health Regulations 2 ( In 2005, all World Health Organization member states accepted responsibilities associated with International Health Regulations that address the management of public health emergencies of international concern. The new rules will "prevent, protect against, control, and provide a public health response to the international spread of disease. Under the revised regulations, countries have much broader obligations to build national capacity for routine preventive measures as well as to detect and respond to public health emergencies of international concern. National public health systems will be expected to establish laboratory capacity that is sufficient to identify, monitor and report in a timely and reliable manner to the health authorities the detection of any agents that may cause epidemics and emergencies. Clearly, the development of LIMS based upon internationally accepted standards will be critical to timely reporting and sharing of information. Also in 2005, the Health Metrics Network (HMN) 3 was established to help countries develop the capacity and expertise for collection and analysis of health information ( HMN, along with its partners, has developed objectives that will have an impact on the implementation of LIMS in resource-limited countries. Those objectives include the following: Creating a harmonized framework for country HIS development (the HMN Framework) that describes standards for health information systems. Strengthening country HIS by providing technical and catalytic financial support to apply the HMN framework. Ensuring access and use of information by local, regional, and global constituencies. The work of HMN and its partners will bring uniformity and a common framework that sets standards for health-information systems and laboratory-information systems and will be an important component of a country s collective data systems. Guidance for the Development of System Requirements Regardless of the direction taken for acquiring a LIMS in the public health setting, the process for making the decision and subsequently designing the system is critical. ICT solutions for laboratory data acquisition and management should specifically address processes and data flow. Before a technical approach is decided to either develop or acquire LIMS, it is important to conduct a thorough process and data flow analysis and develop a business case for the proposed system to properly address the constraints or gaps. This mapping exercise is essential to identifying gaps in the flow of data. Since many proprietary LIMS are often not easily customizable to the specific needs without high costs, it would be important to conduct a needs assessment before deciding on a technical approach. The Clinical Laboratory Standards Institute (CLSI) has published guidance documents related to selection and performance of clinical laboratory information systems including functional requirements and other aspects of information-system performance ( While these documents are focused on clinical settings in the U.S., they provide excellent information that would be valuable in going through the process of acquiring a LIMS in international settings. More specific to international settings, the APHL and the USG Office of Global Health developed a Guidebook for Implementation of Laboratory Information Systems in Resource Poor Settings. 4 This guidebook addresses in detail the steps required to implement a LIMS acquisition process (Figure 1), whether a stand-alone system or a web-based product. The guidebook is one of four documents developed by APHL. Other documents include: 1) High Level Requirements (HLR) identifies information-system standards for objectively evaluating LIS applications as well as detailed functionalities of an LIS ( 2) LIS Toolkit a companion document to the HLR intended for technical staff. 3) LIS Software Provider Report an updated list of commercially and publicly available laboratory software applications. 3

4 APHL and the CDC Global AIDS Program are sponsoring an international meeting in Vietnam in September 2008 to update the APHL document and to discuss standards. As a result of the work of these international and national organizations, a number of guidance documents are available as is technical assistance from these organizations, which can assist countries in the process of selecting and implementing a laboratory-information system. Country Experiences For the reasons described above, countries and private donor organizations have expressed recent interest in laboratory strengthening, including the strengthening of laboratoryinformation systems in resource-limited countries. Because many of these activities are recent, there are few publications in the scientific literature describing experiences in implementing LIMS. However, programs that have supported the development of LIMS in resource-limited settings (e.g., PEPAR and the Global AIDS Program GAP) are in various stages of implementation. While the initial focus for GAP is on the functions that are important to HIV care and treatment (e.g., hematology, cell counting [CD4], EIA, and viral load) and to HIV program support, other functionalities are often present in LIMS but not yet implemented. Following is a brief description of countries experiences (not intended to be comprehensive) while implementing a LIMS. Some countries have chosen to implement by partnering with organizations that help them through that process. For example, the APHL has worked with a number of countries to assist in the implementation process ( default.aspx). In Mozambique, four laboratories have implemented a LIMS and that system has been in place for two years. Tanzania is in the process of implementing, and in that setting the LIMS is being interfaced with automated laboratory equipment (hematology cell counters, chemistry analyzers, EIA readers) and is also being used for the tuberculosis and histopathology laboratories. APHL followed their own guidelines, which were published in 2006, and worked with the country in selecting a vendor. Local support for hardware was an important component of the decision-making process, as was ready availability of software support. APHL is also at the early stages of providing assistance in Vietnam using open-source software (Open ELIS developed and used by two states (Iowa and Minnesota) and other states are considering implementation of this open-source product. Vietnamese IT staff traveled to the U.S. for training in Minnesota, where the application is running. This opensource software is being implemented in Hanoi and in Ho Chi Minh City. While the initial focus will be on those services supporting HIV programs, the application has utility for other laboratory services and the intent is to expand the system to cover other services. APHL is also starting to work with Kenya. Other countries have completed implementation or are in the process of doing so with assistance from various partners (e.g., Zambia and The University of Alabama, Peru and Harvard, Haiti and the University of Washington) and a variety of vendors currently have applications operating in various countries. In 2004, Namibia replaced a proprietary system with another proprietary product that addresses billing/accounting; materials management; storage and supply management; specimen requisition (patient demographics, test requests, and the date and time); and results and reports. The system supports a network of more than 30 laboratories. In addition, as mentioned earlier, open-source software (Open ELIS) has recently been developed by a consortium of six state laboratories in the U.S. and its use is being discussed in several countries. A recent publication by Blaya et al. 5 cites the development of a web-based LIMS in Peru that addresses tuberculosis-patient care. This system (e-chasqui) was deployed in the national TB laboratory, two regional laboratories and in 12 pilot health centers. High user satisfaction led to expansion of the system. This system has been implemented in OpenMRS ( for other countries use. Challenges faced in the implementation of the system included a lack of trained personnel, large coverage areas, and a lack of transportation. These are issues faced by many resource-limited countries. And while focused on tuberculosis, the process described (needs assessment, work flow analysis, and system design) are principles applicable to any implementation. Lessons Learned The lessons learned from the recent activities are similar to those learned during implementation in developed countries. The importance of the process cannot be overestimated, nor can the 4

5 commitment of time and effort. In most cases, a process that requires approximately one to two years is not unusual. Problems that have arisen during the process of acquiring a LIMS are often associated with a lack of complete specifications development and/or a lack of responsiveness on the part of the vendor. The process will often require some outside technical assistance and guidance that draws from the experience of others who have implemented LIMS. The process needs to be led by senior management to assure an understanding of the commitment (immediate and ongoing) that is required. A working group made up of key customers of the laboratory must participate in the process of defining and developing functional requirements. The lessons cited by Blaya et al. in their experience in Peru support the experiences of others: stakeholders must participate; political support is essential; training in use and benefits must be provided; sustainability (software/hardware support) must be assured; and implementation should happen as part of a larger structural improvement (e.g., a component of the larger public health information system needs). Adherence to these principles will help to minimize subsequent problems and help assure that a LIMS can be integrated into broader health functions within the country and internationally. Conclusion The activities of government agencies, donor organizations, and professional organizations described in this paper provide evidence that the development of sustainable LIMS in resourcelimited countries is attainable. In addition, the partnerships that have been described and the guidance documents that are available can help ensure that countries have the technical assistance required to enable evidence-based decisions for the development and implementation of LIMS. It is clear that the current needs of country programs and the needs of the international community (e.g., international health regulations) can be better addressed through the development of a LIMS that incorporates internationally recognized standards. Such a system will be a critical element of the information infrastructure of a public health system in any country. Guidance and technical assistance from professional organizations and university partners is available and can help assure that barriers to successful implementations are minimized. Figure 1. Implementing a Countrywide LIS: Nine Critical Steps 1. Form Working Group 2. Determine functional requirements at typical sites 3. Decide standard or rapid methodology 4. Define scope and needed resources 5. Develop RFP using HLR template 6. Distribute RFP and select provider 7. Negotiate provider contract 8. Initiate project, LIS changes, and system validation 9. Deploy LIS and plan for next phases of project Source: Guidebook for Implementation of Laboratory Information Systems In Resource Poor Settings (Association of Public Health Laboratories publication January

6 References 1 Becker SJ, Blank EC, Martin R, and Skeels M. Public Health Laboratory Administration. In: Novick LF and Mays GP, eds. Public Health Administration. Gaithersburg, MD: Aspen Publishers; 2001: WHA58.3 Revision of the International Health Regulations. January Fifty-Eighth World Health Assembly. 3 The Health Metric Network Framework 2nd Edition, January Guidebook for Implementation of Laboratory Information Systems in Resource Poor Settings. Association of Public Health Laboratories; January Blaya JA, Shin SS, Yagui MJA, Yale G, Suarez CZ, and Asencios LL, Cegielski JP, Fraser H. A webbased laboratory information system to improve quality of care of tuberculosis patients in Peru: functional requirements, implementation and usage statistics. BMC Medical Informatics and Decision Making. 2007; 7:33 ( 6