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.

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.