Journal:Project management in laboratory medicine

Full article title	Project management in laboratory medicine
Journal	Journal of Medical Biochemistry
Author(s)	Lippi, Guiseppe; Mattiuzi, Camilla
Author affiliation(s)	University of Verona, Provincial Agency for Social and Sanitary Services (Trento, Italy)
Primary contact	Email: giuseppe dot lippi at univr dot it
Year published	2019
Volume and issue	38(4)
Page(s)	401–6
DOI	10.2478/jomb-2019-0021
ISSN	1452-8266
Distribution license	Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International
Website	https://content.sciendo.com/contentpage/
Download	https://content.sciendo.com/downloadpdf/journals/jomb/38/4/article-p401.xml (PDF)

Abstract

The role and responsibilities of laboratory managers have considerably evolved during the past decades. This revolution has been mostly driven by biological, technical, economic, and social factors, such as a deepened understanding of the pathophysiology of human diseases, technical innovations, renewed focus on patient safety, cost-containment strategies and patient empowerment. One of the leading consequences is an ongoing process of reorganization, consolidation, and automation of laboratory services, whose propitious realization strongly relies on establishing an efficient project management plan. In a practical perspective, the leading drivers of project management in laboratory medicine encompass various activities supporting a clear definition of the local environment, an accurate planning of technical resources, the acknowledgement of staff availability and qualification, along with the establishment of a positive and constructive interplay with hospital administrators. Therefore, the aim of this article is to provide a personal overview on the main drivers and outcomes of project management in laboratory medicine, which will expectedly contribute to construct a new consciousness and an innovative and multifaceted job description of laboratory professionals worldwide.

Keywords: laboratory medicine, diagnostic testing, project management, automation

Introduction

Laboratory medicine is conventionally defined as a science committed to generate clinical information through analysis of concentration, composition, and/or structure of different analytes in different biological fluids. To be thoughtfully capable of providing a valued contribution to clinical decision making, laboratory medicine services shall hence be developed and organized for maximizing productive efficiency and optimizing clinical efficacy. Unlike many years ago, when healthcare services were not so strongly plagued by shortage of funding and could benefit from ample economic resources, the current scenario is now overwhelmed by an unprecedented worldwide economic crisis, which has also obligated laboratory managers to increase volume and complexity of testing, contextually preserving quality and cutting down costs. This altered scenario has inevitably forced laboratory managers and laboratory professionals to become familiar with many different tools borrowed from other professions, such as leadership skills, budgeting activities and, last but not least, project management.

According to a common inception, project management can be defined as the practice of initiating, planning, executing, monitoring and closing a specific work, aimed at achieving specific goals at a specified time. Project management is hence conventionally dictated by six main paradigms: efficiency, efficacy, quality, safety, sustainability, and satisfaction. The practical translation of these essential factors in the field of laboratory medicine is summarized in Table I. Briefly, efficiency implies achieving maximum laboratory productivity with minimum wasted effort or expense, while efficacy is mainly directed towards improving diagnoses and clinical outcomes. Quality encompasses reaching the highest possible degree of reliability and safety of laboratory data, safety develops through limiting the risk of injury or damage to patients and staff, and sustainability requires avoiding depletion of human and economic resources. Finally, satisfaction is achieved by fulfilling wishes, expectations, or needs of both laboratory staff and its stakeholders (i.e., patients and doctors).

Table 1. The six paradigms of project management in laboratory medicine Paradigm Description Efficiency To achieve maximum laboratory productivity with minimum wasted effort or expense Efficacy To achieve better diagnoses and improved clinical outcomes Quality To develop the highest possible degree of reliability and safety in test results Safety To limit the risk of injury or damage to patients and laboratory staff Sustainability To avoid depleting human and economic resources Satisfaction To fulfill both laboratory staff and stakeholders’ (i.e., patients’, doctors’) wishes, expectations, and needs

From a practical perspective, the main drivers of project management in laboratory medicine encompass some fundamental but not essentially sequential steps, which entail a clear definition of the environment, an accurate planning of technical resources, the acknowledgement of staff availability and qualification, and the establishment of a positive and constructive interplay with hospital administrators. These steps are now further detailed.

Step 1 - Defining the environment

As laboratory medicine continues to evolve from the performance of many manual activities towards the automation of several steps throughout the total testing process, so-called open-plan layouts are becoming commonplace to efficiently respond to the emerging issue of connecting many laboratory analyzers within the same system and developing an efficient workflow, from arrival of samples in the laboratory to their final discharge or storage once testing has been completed. Space availability and organization shall hence be regarded as major limiting steps when projecting the final layout, since the preexisting environment may not be suited to accommodate multiple laboratory analyzers and their connecting systems within the available space. Although the possibility to start from zero (i.e., constructing a new purpose-built structure) is indeed the most desirable and advisable scenario, this rarely happens since the reorganization of most laboratory services goes through cosmetic rearrangements or modernization of preexisting buildings. This would actually force laboratory managers to find a reasonable way to fit the elephant (i.e., automated laboratory instrumentation) into the room (i.e., preexisting environment). Indeed, many different solutions have been made available after the development of flexible laboratory automation, spanning from narrow automation of diagnostic areas (i.e., automation of clinical chemistry and/or immunochemistry testing), up to complete automation of the largest part of laboratory diagnostics (i.e., total laboratory automation; TLA). The choice between the many available solutions of laboratory automation is dependent on the available space for connecting multiple instrumentation and the residual (i.e., vital) space necessary for allowing the laboratory staff to work on the instrumentation and contextually perform maintenance or repairing, when these activities will be needed.

Whatever solution can be finally implemented, laboratory managers must be aware of the risk of the so-called "point of no return," which is defined by the impossibility of easily and inexpensively reorganizing an inefficient laboratory layout once this has been definitely developed. In the unfortunate case of the final project partially or totally proving inefficient and nonfunctional, changing the layout could lead to catastrophic economic consequence, or can even be unfeasible.

Step 2 - Planning technical resources

In the complex effort of planning the technical resources needed for achieving a given target (i.e., constructing a new laboratory layout), developing and documenting the project vision, mission, goals, and deliverables are essential prerequisites. More often than not, these activities are overlooked or completely ignored, whilst the vision and mission of the clinical laboratory should be aligned with those of the complex organization where the laboratory operates. Not ably, laboratory services are now frequently organized in networks, with the reference center in the middle (i.e., the so-called "hub" facility) and many decentralized laboratories in periphery (i.e., the so-called "spokes"), interconnected with an efficient system of sample deliverance and a versatile laboratory information system (LIS). This actual organization requires developing the clear-cut concepts of clinical-laboratory liaison and diagnostic stewardship, according to which the laboratory shall be engaged in reorganizing its structure (instrumentation, tests, staff) for providing an effective technical and advisory support to the local clinical needs within the network, whilst clinicians shall fairly cooperate with the laboratory staff for identifying the most efficient and effective solutions according to location and resources availability. An optimal balance should hence be always identified between case-mix (i.e., clinical complexity) of the healthcare facility where the laboratory is set and the locally available panel of diagnostic tests.

As an example, a regional reference center for management of severe bleeding disorders shall be equipped with a clinical laboratory capable to perform second-line and even third-line hemostasis tests, whilst a peripheral hospital within the same network would only need a basic hemostasis laboratory, since patients with severe bleeding disorder, either congenital or acquired, would be generally admitted and managed elsewhere. In the case that a patient with a bleeding syndrome is brought to a peripheral facility, the local "spoke" laboratory can then support clinicians with a panel of first-line (screening) hemostasis tests (e.g., prothrombin time, activated partial thromboplastin time, fibrinogen, platelet count, screening of platelet function). In most cases these tests—along with the clinical history, signs, and symptoms—will be sufficient to guide clinical decision making and the decision as to whether the patient may need to be referred to the reference center (where the "hub" laboratory is available) for being further investigated and eventually managed, or can else be locally treated or safely discharged. This paradigmatic example can then be translated to the vast majority of laboratory medicine areas (e.g., hematology, immunochemistry, microbiology), by defining a clear hierarchy of tests that should be available in the different laboratories operating within a network. Regardless of personal inclinations and interests, "spoke" laboratories will generally need to be equipped with basic (first-line) laboratory tests, whereas "hub" laboratories will require more complex, time-consuming, and expensive (second- and third-line) analyses. As previously discussed, decisions on the final organization of laboratory diagnostics within a network of laboratory services must be taken in accordance with clinicians and hospital administrators, thus fulfilling clinical needs, principles of cost-effectiveness, and pre-analytical requirements. Dissipating both human and economic resources for performing obsolete, redundant, clinically questionable, or potentially unreliable analyses would not be beneficial for the healthcare system as a whole.

An accurate plan of technical resources will hence encompass a thorough analysis of the local situation, which will then influence the design of laboratory layout, preferably driven by validated tools such as Lean management systems, which contextually enable to maximize efficiency and create a culture of continuous improvement. The leading factors associated with this process are volume and complexity (i.e., capacity), equipment and utility lists, staffing model, work schedule, regulatory considerations, safety ergonomic requirements, and, given space availability, research and education considerations (i.e., in academic centers).

Step 3 - Staff availability and qualification

Whether this third step should follow or anticipate the planning of technical resources remains debated. This is mostly due to a recent metamorphosis that has occurred in staff availability. Personnel requirements have basically evolved from a demand conditioned by workflow, complexity and environment to a new scenario where shortage of public healthcare funding has contributed to make environment and staff availability (and qualification) the leading drivers of workflow and complexity. In 2014, a statistics of the World Health Organization (WHO) has alarmingly highlighted that the global shortage of doctors, nurses, midwives, and other healthcare professionals had already reached a 4.3 million deficit around the world. The situation has worsened in recent years, so that the predicted worldwide shortage of health care workers will probably exceed 15 million by the year 2030. Laboratory medicine makes no exception to this rule, since inefficient turnover has involved almost each category of laboratory professionals, especially during the past decade. It is hence rather understandable that laboratory managers must place staff availability among the top list of drivers of project management. Rome wasn’t built in a day, though it would have never been built without a huge and skilled Roman workforce.

Mutatis mutandis, volume, and complexity of laboratory testing must accurately be commensurate to the local availability of staff and to specific personnel education and qualifications. Importantly, when the available human resources do not meet predefined requirements of workforce and skills, additional strategies are required. These additional strategies must address further elimination of manual activities, automation of additional parts of the total testing process, and expanded consolidation of many different diagnostic areas, including the worst case scenario of reducing volume and complexity of diagnostic testing, or even outsourcing tests to private facilities. Among the possible solutions, this last option has recently gained significant momentum and has become especially appealing for some healthcare administrators, who are seeking to save money by cutting down laboratory funding and externalizing large volumes of tests. Whether or not this strategy is cost-effective remains largely disputed, although recently published evidence attests that outsourcing laboratory services decreases sample quality, increases turnaround time, and enhances the overall risk of diagnostic errors. Sizeable privatization of diagnostic testing is neither a clear-cut solution to the problem, since no reliable evidence has been provided that this will generate improved services and overall cost savings. Moreover, many doubts have been raised around the fact that private contractors do not need to openly disclose how public health money is spent, allocated, or collected. The meteoric ascent of Theranos in the firmament of laboratory medicine, followed by its rapid downfall, has taught us to be cautious in moving towards certain types of deregulated diagnostic testing.

Notes

This presentation is faithful to the original, with only a few minor changes to presentation, spelling, and grammar. We also added PMCID and DOI when they were missing from the original reference. Otherwise, in accordance with the NoDerivatives portion of the original license, nothing else has been changed.