John Chinemerem Ogbete, AbuYusuf Aminu-Ibrahim, Obinna Chima Iwuanyanwu
Scaling molecular diagnostic facilities is essential for meeting growing demands for infectious disease surveillance, oncology, genetic screening, and precision medicine, particularly across resource-constrained and rapidly expanding health systems. This study examines how standardized infrastructure and operational design models can enable scalable, high-quality molecular diagnostics while ensuring biosafety, regulatory compliance, and cost efficiency. It synthesizes insights from laboratory engineering, health systems planning, and diagnostic network design to propose an integrated approach to molecular facility expansion. Standardized infrastructure models emphasize modular laboratory layouts, flexible cleanroom zoning, validated airflow and contamination control systems, and harmonized utilities for power, water, and waste management. These design principles enable rapid replication, phased expansion, and adaptability to evolving assay technologies without compromising analytical integrity. Operational design models complement physical standardization through optimized workflow sequencing, sample logistics, equipment utilization, and quality management systems aligned with international laboratory standards. Together, these models reduce setup time, minimize variability, and support consistent performance across decentralized molecular testing sites. The study further highlights the role of digital enablement in scaling molecular diagnostics, including laboratory information management systems, remote monitoring platforms, and standardized data architectures that support traceability, quality assurance, and network-level oversight. Workforce-aligned operational models, incorporating task differentiation, competency-based training, and remote supervision, are identified as critical to sustaining performance in settings with limited specialist capacity. Financing and governance mechanisms, including pooled procurement, regional laboratory networks, and public–private partnerships, are discussed as enablers of affordability and long-term sustainability. The study concludes that scalable molecular diagnostic capacity depends on the integration of standardized infrastructure with adaptive operational design. By embedding flexibility, quality assurance, and interoperability into facility and workflow models, health systems can rapidly expand molecular testing while maintaining safety, reliability, and regulatory alignment. Such approaches strengthen outbreak preparedness, support routine disease management, and advance equitable access to advanced diagnostics across diverse healthcare contexts. Importantly, standardization does not constrain innovation but provides a stable platform for continuous technological evolution, network optimization, and resilient diagnostic system growth in low-, middle-, and high-income settings globally. These frameworks also facilitate benchmarking, performance comparison, regulatory audits, and coordinated scale-up across national, regional, and cross-border diagnostic ecosystems worldwide.
AbuYusuf Aminu-Ibrahim, John Chinemerem Ogbete, Kazeem Babatunde Ambali
Expanding diagnostic access across underserved and rural healthcare regions remains a critical determinant of health equity, early disease detection, and system-wide resilience. Infrastructure-driven approaches offer a pragmatic pathway to closing persistent diagnostic gaps caused by geographic isolation, workforce shortages, fragmented referral networks, and underinvestment in health facilities. This paper examines how strategic development of physical, digital, and organizational infrastructure can enable scalable, sustainable diagnostic services in low-resource and rural settings. It synthesizes evidence from health systems strengthening, rural health planning, and diagnostic network design to identify core infrastructure enablers that improve access, quality, and continuity of care. Key infrastructure components include decentralized laboratory hubs, modular and prefabricated diagnostic facilities, reliable power and water systems, cold-chain and specimen transport logistics, and interoperable health information systems. When combined with digital connectivity, telepathology, and point-of-care diagnostics, these assets reduce turnaround times, minimize patient travel burdens, and support timely clinical decision-making. The paper further highlights the role of workforce-aligned infrastructure, emphasizing training-centered facility design, task-shifting support spaces, and remote supervision platforms that extend specialist expertise into rural contexts. From a policy and financing perspective, infrastructure-driven expansion requires coordinated investment models that align capital planning with service delivery objectives. Public–private partnerships, performance-based financing, and regional diagnostic networks are discussed as mechanisms to de-risk infrastructure investment while ensuring affordability and long-term operability. Governance frameworks that integrate maintenance planning, quality assurance, biosafety, and regulatory compliance are identified as essential to preventing infrastructure decay and service fragmentation. The papaer concludes that infrastructure is not merely a physical input but a systems-level enabler of equitable diagnostic access. By embedding diagnostics within resilient infrastructure ecosystems that integrate technology, logistics, workforce capacity, and governance, health systems can extend high-quality diagnostic services to underserved and rural populations. Such infrastructure-driven strategies are foundational to universal health coverage, pandemic preparedness, and the reduction of avoidable morbidity and mortality in marginalized regions. Importantly, infrastructure planning must be context-sensitive, data-informed, and community-engaged, ensuring that diagnostic expansion aligns with local disease burdens, cultural practices, referral pathways, and sustainability constraints while promoting trust, utilization, and long-term health system integration across diverse rural geographies globally and fragile health markets.
Background Over the past two decades the quest for safe blood supply has led to tremendous growth in the content and scope of the science and practice of Transfusion Medicine (TM). The desire by the various stakeholders in the blood establishment for zero‐risk blood transfusion has not only stretched the level of quality expected of the Transfusion Medicine Service to apical height, but has also resulted in the demand by these stakeholders for concrete proofs that expected degrees of quality have been met or preferably exceeded. Quality indicators (QIs) are a Quality Management System (QMS) tool that are instituted in an organization with intent on not just providing this much needed proof of the level of quality performance tenable in the organization, but they are also intent on utilizing the information gained to seek improving the quality of performance in the organization. In the last decade, huge efforts have been exerted by government and non‐government hospital‐based blood banks, national and international organizations to collate, select, establish and analyze quality QIs for several dimensions of healthcare quality. Notable contributions have been made by such eminent bodies as the Agency for Healthcare Research and Quality (AHRQ), the Organization for Economic Cooperation and Development (OECD) and the College of American Pathologists (CAP). Unfortunately these efforts have only sparsely addressed quality indicators for TM. A year ago, the International Society of Blood Transfusion (ISBT) instituted its Working Party on Quality Management (WPQM). Quality indicators for TM are of priority to the WPQM which presumably is intent on redressing this imbalance and providing robust and valid quality indicators to monitor quality performances in key processes and outcomes in TM practice, globally. Objective This paper therefore highlights some basic essentials for successful monitoring of quality of transfusion medicine service through appropriate selection and implementation of quality indicator projects. It is hoped the information shared through this medium might be of value to Transfusion Medicine practitioners as well as to the ISBT WPQM as they thinker with quality indicators for Transfusion Medicine. Material and Method Considerable review of published literature in the form of journal articles, books and online publications on quality management and quality indicators in Healthcare/Transfusion Medicine was performed with the view to extract essentials elements that could be considered building blocks for the selection, implementation, analysis and utilization of quality indicators in Transfusion Medicine. Result Elements deemed as essential building blocks that were appraised included, but were not limited to: understanding Transfusion Medicine terrain; concept of quality and quality indicators selection criteria; choice of improvement model, data analysis and manner of communication of findings as well as the role of effective education and leadership. Conclusion Quality indicators are indispensible tools which various stakeholders in the Blood Transfusion establishment now demand to adjudge and improve on quality performance. Practitioners as well as policy makers in Transfusion Medicine need to ensure that the quality indicators they institute are appropriately selected and analyzed to be effective and efficient monitors of quality. Knowledge of basic building blocks discussed here is therefore a fundamental prerequisite.
In this issue of Clinical Infectious Diseases, Petti and colleagues [1] highlight the need for increased investment in laboratory services to avoid compromising patient care. Health care professionals are waking up to the realization that the development of new drugs and treatment strategies has far outstripped the ability of health care systems to deliver them to individuals who need them. The decision has been made by leading global health care funders that cost should not be a deterrent to providing effective treatment, even in the poorest countries. As a result, there are major drives to rapidly increase availability of antiretroviral drugs and antimalarial combination therapies. A similar and potentially stronger argument for prioritizing effectiveness over cost pertains to the provision of accurate frontline diagnostic services. Yet, as Petti and colleagues [1] illustrate, there is widespread use of “empiricism without laboratory support for diagnosing disease” in sub-Saharan Africa, which would not be tolerated in resource-plenty countries. What can be done to redress the imbalance and bring investments in diagnostics to a level that will support cost-effective deployment of available treatment regimens in sub-Saharan Africa? Let us consider how this might be achieved by exploring opportunities within the major areas of concern discussed by Petti et al. [1]: clinical misdiagnosis, inadequate health care infrastructure, and laboratory capability and diagnostic accuracy. Almost none of these opportunities can be realized by laboratory services in isolation; they depend on close partnerships between technical and clinical professionals and local and national health care managers. For many common infections in sub-Saharan Africa, including severe and nonsevere malaria and septicemia, clinical diagnosis is not adequately sensitive or specific. Because malarial and bacterial infections share similar presenting features, syndromic management [2] results in overtreatment of both conditions, increasing the expense and threatening the longevity of the limited repertoire of inexpensive antimicrobials. Often, frontline medical personnel have to make immediate clinical decisions on the basis of a limited number of diagnostic tests. Equally important are the refinement of this initial diagnosis and the targeting of therapies over the ensuing hours and days, which is greatly facilitated by good diagnostic facilities; thus, the laboratory is the most important determinant in this process. Ideally, rapid and accurate diagnostic testing would be available at the first consultation, to enable personnel to make the correct diagnosis and to avoid the waste of resources and increased ill health associated with incorrect initial diagnoses. In some cases, such diagnostic tools are available but are not in routine use, because they are considered to be too expensive or because they have not been adequately evaluated in real-life situations. Such tools include rapid dipstick malaria tests, anemia and HIV tests, and fingerprick hemoglobinometric tests. Much more investment is needed to evaluate and adapt existing tools and to develop new diagnostic approaches for common conditions. This is likely to be most effectively achieved through partnerships between researchers, policy makers, and commercial companies that are similar to the programs that have been used for drug development (e.g., Medicines for Malaria Venture). The availability of such diagnostic tools is not likely to greatly impact clinical care unless their use is underpinned by evidence-based guidelines that are implemented, supervised, audited, and embedded within local practice. The process of producing guidelines is based on the synthesis of published evidence from diverse sources and then adaptation to suit local circumstances, and it needs to involve collaboration between clinicians and laboratory professionals. A proposal to simplify the complex process of guideline development has been proposed recently by Raine et al. [3]. Laboratory services are one of the most neglected areas of health care provision in sub-Saharan Africa and are disproportionately affected by the staff shortages, poor communications, inadequate equipment, low morale, and lack of training that impinge on all those involved in delivering health care in poorer African countries. The reforms currently underway in the health care sector in many sub-Saharan African countries and the consequent decentralization of planning and financing could be used as an opportunity for laboratory services to move up on the priority list of essential services. This will only happen if laboratories represent themselves on key decision-making bodies, rather than being represented by other sections of health care services, such as pharmacy. Within top-level management, the voice of clinicians is generally much more powerful than that of laboratory professionals. Clinicians therefore have a responsibility to support and advocate for their technical colleagues in the laboratory service, to ensure that they are involved in decisions affecting the laboratory at all levels, and to promote, facilitate, and demand high-quality and responsive laboratory support for effective patient care. The fact that a test was done by a senior technician or that it was performed on a sophisticated piece of equipment in no way guarantees the accuracy of the results. Establishing, maintaining, and demonstrating the accuracy of diagnostic tests is a major challenge for most laboratories in sub-Saharan Africa. To do this, they need to have the skills and resources to institute regular internal quality checks for each test, reliable documentation processes, and access to an external reference center that is itself linked to and accredited by international quality-assessment networks. Laboratories must be able to show that they perform well in such an external quality-assessment scheme before clinicians can be confident that the results of tests they request will be accurate. The complexity and cost of setting up and maintaining such a quality-assurance system means that only a very few laboratories, almost exclusively those that are tertiary or privately owned, can provide evidence that their results are accurate. There are a few examples of innovative local schemes for simple external quality checks on key laboratory tests—for instance, sending blood samples, malaria slides, or sputum smears for tuberculosis diagnosis to neighboring laboratories and then meeting regularly to compare results and to reflect on any discrepancies. In addition, there are particularly good examples of local quality-assurance systems designed to evaluate testing in tuberculosis control programs that could be expanded to include the malaria test (another microscopy-based test) and further extended to other essential laboratory investigations, such as hemoglobin and transfusion-related tests. Even these local schemes require a high degree of motivation and organization by the laboratory staff, as well as support from clinicians and regional or national health care managers. Qualityassurance networks are one of the areas in which nongovernmental organizations and the private sector could play a much greater role, particularly in places where governmental health care systems are ineffective or dysfunctional. Outsourcing external quality assessment to such agencies would bring many mutual benefits, especially because many of the public-sector laboratory staff also work in the private sector. The current international focus on rapidly widening the access to antiretrovirals can be perceived as either a threat to or an opportunity for laboratory services in sub-Saharan Africa. It is a potential threat because strong vertical programs concerned with HIV care and management focus on the HIV-related aspects of laboratory services, thereby fragmenting the service and diverting scarce resources, particularly human resources, away from important non-HIV tests, such as those for malaria, anemia, and tuberculosis. On the other hand, if laboratory aspects of HIV programs are able to integrate into and strengthen existing systems, they will provide a unique opportunity to build the capacity of long-neglected laboratory services in sub-Saharan Africa. It is very surprising that the article by Petti et al. [1], which is wholly concerned with the provision of laboratory services in sub-Saharan Africa, does not include an African author. Is this indicative of the dearth of indigenous laboratory advocates in sub-Saharan Africa? As treatment costs for common conditions increase in poorer countries, the balance must shift away from syndromic management toward achievement of specific diagnoses. Laboratory services will have an increasingly important role to play in improving the quality and effectiveness of patient care, but, to do this, laboratories and their advocates need to be given a much louder voice on the international health care stage. Potential conflicts of interest. I.B. and K.M.: no conflicts.
Reduced reimbursements from the federal government and third-party payors have threatened the financial viability of many hospitals. An increasing number of hospitals are losing money from their primary mission of caring for patients. The hospital “industry” is still viewed by many as inefficient. Hospitals are generally not run like businesses, nor is it really possible for them to function in the same manner because they have to provide services, to some extent unpredictable, 24 h a day, 7 days a week. Unlike businesses, they cannot increase the charges to their clients to any significant extent when their costs increase because fees are largely dictated by the federal government. For no other business is there the equivalent of capitation or dictation of prices by outside organizations as there is in the medical business. It is perhaps easier for hospital administrations to assess the productivity of their clinical laboratories than of most other hospital services. The number of tests, the number of staff, and the cost of running the service as determined by the supply and salary budgets can be readily quantified. Furthermore, these factors can be bench-marked against the performance of other institutions. However, clinical laboratories also have to contend with the absurd concept of the “billed test” beloved by the federal government, insurance carriers, and consulting companies lacking laboratory expertise. The “billed” test assigns equal weight to a multitest outpatient panel as it does to a dipstick urinalysis or to an elaborate genetic test that is labor-intensive and may take days to complete. This ridiculous concept makes comparisons of productivity between institutions impossible. Indeed, the billed test concept hides increases in productivity because one billed outpatient test may generate as much work as 12 inpatient tests. Successful efforts by hospitals to reduce their inpatient testing, because of non-reimbursability, then mask any increase in revenue-generating outpatient tests. This dual objective of reducing unnecessary inpatient testing and capitalizing on the potential for outpatient revenue has become a major charge for the responsible clinical laboratory director. Clinical laboratories everywhere have been faced with the challenge of doing more tests at less cost, i.e., boosting their productivity. Many laboratories have reached the point at which it is impossible to increase productivity using the equipment that they have. Although each generation of “automated” analyzers usually provides some improvement in throughput and turnaround time for results, they do not have the ability to make the quantum improvements that are a prerequisite to significantly improving productivity. This has led to the concept of “total laboratory automation”, as much a misnomer as “automation” is for a single laboratory instrument. Total laboratory automation goes beyond the automation of analyses but includes automation of much of the important hitherto labor-intensive manual preanalytical phase in the process. The concept was conceived in Japan and has been widely accepted there, so that many large Japanese hospitals now include robotized specimen processing and delivery systems. In the United States, only a very small proportion of even the largest hospital and reference laboratories have installed such systems. Clearly, many laboratory directors have been waiting to learn of the success, or otherwise, of the automated systems in daily operation before they, too, embark on such a major investment. Many also remain uncertain as to whether maximum centralization, as represented by total laboratory automation, is to be preferred over maximum decentralization, as represented by point-of-care testing. The 1999 Clinical Chemistry Forum was designed to present the arguments as to why a fresh approach to laboratory testing was needed and to detail the steps necessary to make the decision whether to commit to total laboratory automation and how to identify the steps involved in a successful installation. The presentations began, appropriately, with discussions of alternative approaches to coping with rapidly escalating workloads. These included total laboratory automation for both individual hospitals and for networks of hospitals. Within the laboratory, alternative approaches were presented, including the use of modular components and automation of selected fixed tasks. The topics covered included a discussion of the components of the necessary overall planning process by a senior administrator from an integrated health system. Another paper dealt with the internal marketing of the concept by the laboratory to the administration and medical staff who would have a major, and vested, interest in the successful operation of a new system. Two of the critical areas that can make or break a robotic system are the layout of the facility with its attendant demands, which involves providing an appropriate environment for both the operators and the analytical systems, and the design and implementation of a superior information system. The latter is essential for capitalizing on the rapid generation of test results. The planning for an automated laboratory entails much more than the operation of the system once it is installed. One of the difficulties in many laboratories is maintaining the daily processing and testing of specimens while a large part of the laboratory’s space is taken out of service during construction. An especially difficult area to manage is ensuring the loyalty and productivity of staff. This is particularly true when they are aware that one of the objectives of installing a robotized laboratory is to reduce labor costs, which must inevitably impact some of the staff whose goodwill and cooperation are essential. This also is essential during all of the steps before the successful introduction of routine operation of the system on a daily basis. A majority of the forum papers are presented here in their full-length form. Four other papers are summarized below that address key problems in working toward an automated laboratory. We believe that the meeting achieved its objective of presenting all of the issues that need to be recognized by a laboratory director before embarking on the very challenging and expensive pathway leading to total laboratory automation. Although this concept has been well accepted in Japan, the small number of installations in the US to date means that those laboratory directors who have installed systems are still pioneers. We are grateful that they were willing to share their experience at the 1999 Clinical Chemistry Forum. In addition, the attendees and the readers of these Proceedings need to recognize the dedication and support given by Jean Rhame and Pamela Nash of the American Association for Clinical Chemistry’s staff, who made the meeting happen. Implementation of total automation of a laboratory is a formidable task. Not only does it ultimately require a large expenditure of money, it requires time and perseverance on the part of its proponents. Two of the papers presented at this forum addressed the very practical issues of getting buy-in from constituencies as diverse as a hospital administration to all of the individuals whose jobs may be threatened by an automated system. A third paper summarized the necessary steps for the overall planning process, and a fourth paper highlighted the critical importance of information handling in a successful robotic facility. These papers are summarized below. Julie A. Fisher, Mount Sinai Medical Center, New York City, discussed selling the concept of a totally automated laboratory to a hospital’s administration and other stakeholders. Successful selling is based on extensive communication and detailed financial and other justifications. There are eight essential elements to successfully selling an automation concept. These are defining goals, assessing needs, obtaining stakeholder buy-in, the decision-making process, vendor selection, the financial planing process, implementation, and metrics. Continuous communication is essential throughout all phases of the project. The wishes of the laboratory must be congruent with those of the administration. The process may be protracted; the cycle between initial concept and routine operation may be as long as 6 years. The trigger for a laboratory to consider automation usually is pressure to reduce costs and improve its efficiency. Automation has the potential to enhance the economic survival of a laboratory, reduce its operating costs, improve the quality of services, and provide a safer work environment. The need for automation should be assessed in the context of whether the institution is planning to expand or to just cut costs. Every ramification must be considered. For example, contractual arrangements with unions must be taken into account. This will become particularly important when the system is fully implemented because contracts may determine who may or may not be laid off. Additionally, needs for upgrading or changing the laboratory information system and analytical instruments must be assessed. A successful automation project depends on stakeholder buy-in. The stakeholders include the laboratory staff, the hospital administration and Board of Trustees, and hospital physicians. It is important to communicate to each of the groups what automation will do for them. Each of these constituencies has different interests and concerns. The laboratory staff are most concerned about job security, but it is important to let them know that automation is a tool to help them perform their jobs differently, and perhaps better. For the administration and Board of Trustees, the focus needs to be on the financial bottom line, with emphases on the opportunity for both revenue enhancement and expense reduction. Other selling points for the administration can include the potential to perform tests for other hospitals and develop group purchasing arrangements with other hospitals for which laboratory services can be provided. Physicians are primarily concerned with turnaround times of test results as well as enhanced information. The financial planning process requires projections of revenue and expenses. A break-even analysis is essential and must demonstrate that automation will reduce costs and/or enhance revenue. Various approaches may be used. A traditional return on investment (ROI) analysis relates net income to investment capital. The formula for calculating a ROI may be refined to take into account sales as well, as in a DuPont analysis. This approach recognizes that it might not be beneficial to tie up assets, thereby lowering profitability. The same formula can be used for an expense analysis by keeping sales constant. The net profit margin increases with a reduction in expenses, and with automation, the key expense reduction is in labor. Technical productivity can be calculated by dividing the number of tests performed by the total number of paid full-time employees or equivalents (FTEs). The calculation of labor savings should take into account how the number of employees will be reduced. With layoffs, there often will be severance and/or retraining expenses to equip the laid-off employees for other jobs. Different laboratory areas will be affected differently. Thus, the laboratories in which automation will be implemented will be more impacted than others. For each laboratory area, a separate projection of staffing needs to be done. Recently, there has been a trend away from justifying automation solely on an ROI analysis because not all of the benefits can be quantified in financial terms. Automation provides added value through improved efficiency coupled with reduction in processing errors, improved turnaround times, automated repeat and reflex testing, enhanced safety, and improved specimen tracking. The active participation of stakeholders in the planning process enhances the laboratory’s ability to sell the concept. Thus, an overall executive committee derives benefits when supported by laboratory management with information systems and instrumentation teams. It is advantageous to enlist stakeholders in vendor selection because acceptance of the system is critically dependent on the their involvement. The more people involved in different aspects of the planning process, the greater the probability of acceptance. Even during the implementation phase, it is important to involve the stakeholders, especially the staff who will be directly affected by the system. During the installation and after the system becomes operational, it is important to continue to communicate to the stakeholders. Information that should be communicated includes actual performance compared with projections, especially with regard to revenue projections and/or expense reductions, the quality of service, and whether a safer environment has been created. Patricia Abbott, Hospital of the University of Pennsylvania (HUP), Philadelphia, discussed the practical aspects of creating a robotized laboratory. Because acceptance of laboratory automation by a hospital’s administration is, to a great extent, dependent on perceived financial benefits, an accurate estimate of the number of employees needed to operate the system is required. The greatest financial returns are likely to arise from reduced labor costs. Unfortunately, the estimate of the number of staff needed to operate a robotized laboratory must be made before the laboratory has any experience with the system or its impact. One of the first steps in the planning process is to decide which tests will be performed in the automated laboratory and which will be performed elsewhere. This decision requires not only an analysis of which tests are performed at each existing bench station but the proportion of tests requested stat vs routine per shift, the number of tests per shift, and the number of technologists working on each shift on each day of the week. With automation, it becomes feasible to combine the stat and routine workbenches for the high-volume tests, but for precise planning of staffing needs, the time of receipt of specimens in the laboratory must be considered. It is also necessary to consider physician needs in deciding which instruments should be interfaced with the robotized and to assess whether greater can be through the test on different analytical the of the planning process, it is essential to assess the and interests of the laboratory staff. This is especially important the laboratory been to a of separate laboratories because there may be a need for extensive of existing on the of the staff in the laboratory at it was to staff the automated laboratory with a staff who would be to operate all of the instruments in the and who would be by staff from the areas working in their areas of expertise. this the laboratory for example, be to on the of of the technologists who would be to operate only the in the automated laboratory to become in operating technologists who been to the and laboratories would not have to the needed to operate a was to assess the of the for working in the automated laboratory, it was on a small number of staff. The for the technologists to assess their to new and for management to assess each potential for a successful to a environment with new for the individuals selected to work in the automated laboratory was each existing The not only on instruments but also on the clinical of the that were new to them and of the results of these tests. before all technologists were to the it was on a selected staff and by their before it was out to all the staff. The of the automated laboratory the laboratory to turnaround time to the the and the in as well as from a processing to a of benefits through of test results possible to the efficiency of testing by the automated laboratory. a the turnaround times for and high-volume tests between in the laboratory information system of the receipt of a specimen and its test results to is now for and for the tests. It is important to have a committee of technologists to at all of work including and in work A of the a of the planning committee once the decision to been made to that the interests of all of the staff were The planning committee has been after the system to Because the staff from different the senior management has with the management of the automated laboratory to their and has with the staff on a as well as on a to that the of the staff are and The senior management a many of the staff a and that problems were to be A committee was as a to and assess problems and The ROI for the project at was based on the of the impact of on the staff, staff were to for all even those not directly affected by the automated laboratory, so that those staff from the automated laboratory be to laboratory the and of these benefits were to them. In the number of that to be was less than been for because of a to tests from other hospitals and the A. the concept of project management as to the of a robotized laboratory. management is as the of and to project to or needs and from a project. Thus, it is a approach to the management of costs, and However, it has only been management requires of a to and manage people and other One individual is to the and is given and to manage the project to its areas of or function are involved in project and the project should have and some in all of them. The primary areas involve the management of cost, and These are by the management of and management is concerned with the of the the overall and of management involves of the necessary the of and the for the project. It is concerned with all aspects of and requires critical and/or as management planning and cost and management all of the of total quality management to that the of the project will the needs of the of the project. management the most use of the people involved in the project and includes and management includes the to the and services needed to the project. management is the function of and to The project must manage or communication so that all of the appropriate people are about the of the project at the appropriate time in the appropriate both and in Each project has a cycle which may have different of and There is no single to manage a but the approach involves the phases of implementation, and the of the concept phase, there usually is only a of a but the of this phase is the for the project. The or design phase usually is when the project is to the project and is the critical detailed planning with planning is the need to develop to and manage of the project. Two critical require the of the people who must the project and the that many individuals working on a project are not working on it The of the phase is a project which should not be The must identify all the necessary and their costs The costs must be to the individual work times and must be with to to the overall project For large such as for installation of a costs with should be as part of the overall project. for costs are of the for for for and of the for the service for the instrument. For large it is to a work which the project to identify the and to to them. A is the for the and of time and cost to be based on is now readily to identify the through the and to determine the of the project. In of the most there is the of with of the project beyond the initial This is not a as long as the project the the cost, and quality and this to the stakeholders. A potential is and to develop management must be a and one of the most to manage is through to can be to whether the can be the probability of is or The latter requires the of a the objectives of the project are it is and its to an Mount Sinai Medical Center, New York City, discussed the critical of a laboratory information system in an automated laboratory. automation involves much more than a robotic system a laboratory. The in an automated laboratory is involved in both analytical and The latter includes both preanalytical such as the processing of and specimen and such as and The provides to the quality and and results and them to the In an automated laboratory, the of the must be integrated with the of the robotic processing and the robotic The each specimen on the robotic system and the robotic process to the and to the specimen and its they might be the system. It and from the robotic system the quality of each primary specimen and the of specimen in the so that specimens may be as It is for tests to be directly into the Not only does this reduce errors, it also has the potential to improve turnaround of to the also and testing. Furthermore, it enhances and provides an accurate time of specimen Within the laboratory, from the to the robotic information and the and system However, such an approach requires or of specimens for which tests were but not on the robotic of the provides in testing and reflex specimen testing. of different of specimens on the but the need to cost and may also a in the testing process because all specimens must through a single An automated laboratory is critically dependent on a and its and system should be in to to of some part of the system. An supply by an is essential to the impact of or in The should have a of that usually share the but with each one of handling the are also needed to provide in one become or to and from the to and and other should be for rapid the system one or more and should also be Each the system should be up to This should be in the at the same time operation of the in the and of the must be with and of the a is it should be in the of the before to the part of the a with the the laboratory staff should to but then should enlist the vendor for The same should be a The staff should provide the laboratory staff with an estimate of the likely so that alternative may be In the of a the medical staff must also be function is this should be communicated to all in the same manner that the was The papers summarized when taken with the full-length papers that will provide the an of the of and with regard to laboratory automation.
All decentralized testing is regulated according to the Clinical Laboratory Improvement Amendments of 1988. Two organizations, the Joint Commission on Accreditation of Health Care Organizations and the College of American Pathologists, have received deemed status for their voluntary standards from the Health Care Financing Administration. Deemed status means that the organizations' voluntary standards meet or exceed the federal requirements. The decentralized testing sites can exercise several options in determining which organization, and hence which set of standards, will be used to regulate their testing processes. In this article, the authors outline the various regulatory requirements, provide insight into the relationship of each, and offer a framework for decentralized testing sites to follow to meet the requirements.
<h3>Objective.</h3> —To examine analytic performance by previously untrained and inexperienced subjects using enzyme-linked immunosorbent assay (ELISA) tests developed for decentralized laboratories. Performance variability between tests assigned to the "simple" and "moderately complex" Health Care Financing Administration laboratory levels was evaluated. <h3>Design.</h3> —A nonrandomized trial of the Surecell Strep-A chorionic gonadotropin ELISA tests. Each subject processed nine unknown specimens (three negative, three weakly positive, and three strongly positive) for each ELISA test. Subjects were blinded to expected test results. <h3>Setting.</h3> —An elementary school. <h3>Subjects.</h3> —A convenience sample of 52 students enrolled in the sixth and seventh grades. This age group was chosen because of their ability to generally comprehend instructions and remain attentive to the testing task. <h3>Interventions.</h3> —Subjects were either self-trained by reading package insert directions or trained by a manufacturer's sales representative. <h3>Main Outcome Measures.</h3> —Performance was measured as the percentage of correct test results for the unknown specimens. The sensitivity and specificity for each test by operator group were calculated. <h3>Results.</h3> —Subjects demonstrated an overall sensitivity of 97.1% and specificity of 94.7% for human chorionic gonadotropin unknown specimens and a 95.9% sensitivity and 96.8% specificity for group A steptococcus unknown specimens. No significant differences between the self-trained group and the representative-trained group were observed for either group A streptococcus or human chorionic gonadotropin tests. Performance was so high with the first specimen that improvement over time (ie, a "learning curve") could not be demonstrated. <h3>Conclusion.</h3> —These ELISA test systems are able to achieve high levels of performance by subjects with no formal laboratory background, no previous method specific experience, and limited self-training. (<i>JAMA</i>. 1992;268:766-770)