Journal:Project management in laboratory medicine - Revision history

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	''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.<ref name="LippiCost18" /><ref name="LippiTheAdd17">{{cite journal \|title=The add value of laboratory diagnostics: The many reasons why decision-makers should actually care \|journal=Journal of Laboratory and Precision Medicine \|author=Lippin, G.; Plebani, M. \|volume=2 \|issue=12 \|at=100 \|year=2017 \|doi=10.21037/jlpm.2017.12.07}}</ref> 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.<ref name="ChasinMedic07">{{cite journal \|title=Medical errors arising from outsourcing laboratory and radiology services \|journal=American Journal of Medicine \|author=Chasin, B.S.; Elliott, S.P.; Klotz, S.A. \|volume=120 \|issue=9 \|pages=e9-11 \|year=2007 \|doi=10.1016/j.amjmed.2006.07.024 \|pmid=17765055}}</ref> 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.<ref name="LacknerTheTheran16">{{cite journal \|title=The Theranos phenomenon, scientific transparency and freedom of speech \|journal=Clinical Chemistry and Laboratory Medicine \|author=Lackner, K.J.; Gillery, P.; Lippi, G. et al. \|volume=54 \|issue=9 \|pages=1403-5 \|year=2016 \|doi=10.1515/cclm-2016-0520 \|pmid=27442369}}</ref>		''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.<ref name="LippiCost18" /><ref name="LippiTheAdd17">{{cite journal \|title=The add value of laboratory diagnostics: The many reasons why decision-makers should actually care \|journal=Journal of Laboratory and Precision Medicine \|author=Lippin, G.; Plebani, M. \|volume=2 \|issue=12 \|at=100 \|year=2017 \|doi=10.21037/jlpm.2017.12.07}}</ref> 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.<ref name="ChasinMedic07">{{cite journal \|title=Medical errors arising from outsourcing laboratory and radiology services \|journal=American Journal of Medicine \|author=Chasin, B.S.; Elliott, S.P.; Klotz, S.A. \|volume=120 \|issue=9 \|pages=e9-11 \|year=2007 \|doi=10.1016/j.amjmed.2006.07.024 \|pmid=17765055}}</ref> 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.<ref name="LacknerTheTheran16">{{cite journal \|title=The Theranos phenomenon, scientific transparency and freedom of speech \|journal=Clinical Chemistry and Laboratory Medicine \|author=Lackner, K.J.; Gillery, P.; Lippi, G. et al. \|volume=54 \|issue=9 \|pages=1403-5 \|year=2016 \|doi=10.1515/cclm-2016-0520 \|pmid=27442369}}</ref>

			Notably, critical issues in staff regulations (e.g., time on turn, recovery) must be clearly identified, and staff necessity should then be defined accordingly. A final consideration concerning personnel is that laboratory directors cannot usually select the staff. As such, they are rather constrained to develop leadership skills which will enable them to manage the existing personnel, thus placing the right person, in the right place, for doing the right activity, at the right time. This obviously entails accurately knowing the potential personnel (i.e., weakness and strengths), trying to fulfill personal inclinations (whenever possible), and, especially, not blaming people when something goes wrong, since errors are frequently caused by a system failure rather than by individual mistakes.

			==Step 4 - Interplay with hospital administration==
			As already anticipated in some previous parts of this article, laboratory professionals are increasingly involved in administrative duties, mostly encompassing test menu optimization, delivering training or education, and administering budgets.<ref name="PlebaniAMani19">{{cite journal \|title=A manifesto for the future of laboratory medicine professionals \|journal=Clinica Chimica Acta \|author=Plebani, M.; Laposata, M.; Lippi, G. \|volume=489 \|pages=49–52 \|year=2019 \|doi=10.1016/j.cca.2018.11.021 \|pmid=30445032}}</ref> It is increasingly essential that laboratory directors and managers have a profound understanding of the budget of their laboratory and use that information for developing appropriate strategies for responding to a clinical demand, learning to manage budgets on the basis of a cost model, and presenting enough details to meet the needs of financial managers. These many aspects have become virtually unavoidable because laboratory diagnostics is now assimilated to many other economic industries by policymakers and administrators and is hence subjected to scale economy and evaluated accordingly. To put it simply, laboratory managers should aim to establish a favorable and constructive interplay with hospital administrators. Laboratory managers will also need to learn the language of hospital administrators and policymakers, since it is highly unlikely that these two categories will be ever strongly committed to speak a clinical language.<ref name="HorvathFromEvi13">{{cite journal \|title=From evidence to best practice in laboratory medicine \|journal=Clinical Biochemist Reviews \|author=Horvath, A.R. \|volume=34 \|issue=2 \|pages=47–60 \|year=2013 \|pmid=24151341 \|pmc=PMC3799219}}</ref>

			Regardless of any local organization, however, it is now undeniable that the future of laboratory medicine will be mostly driven by national healthcare policies, which are typically defined by a number of paradigms such as the amount of public funding for ''in vitro'' diagnostic testing, health insurance strategies, and test reimbursement policies. On a local basis, it will become increasingly essential to define medium- and long-term trajectories with hospital administrators, especially in terms of reorganization of the healthcare network (which will then influence number and size of laboratory services), number of hospital beds and outpatient flow (which will then influence test volume), and case-mix evolution (which will then influence test menu). Knowing this information in advance is necessary for developing an efficient and effective project management plan in laboratory medicine.

			==Conclusions==



			<ref name="JassamTheEuro18">{{cite journal \|title=The European Federation of Clinical Chemistry and Laboratory Medicine syllabus for postgraduate education and training for Specialists in Laboratory Medicine: Version 5 - 2018 \|journal=Clinical Chemistry and Laboratory Medicine \|author=Jassam, N.; Lake, J.; Dabrowska, M. et al. \|volume=56 \|issue=11 \|pages=1846–63 \|year=2018 \|doi=10.1515/cclm-2018-0344 \|pmid=29870392}}</ref>

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	==Step 3 - Staff availability and qualification==		==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.<ref name="AluttisTheWork14">{{cite journal \|title=The workforce for health in a globalized context--global shortages and international migration \|journal=Global Health Action \|author=Aluttis, C.; Bishaw, T.; Frank, M.W. \|volume=7 \|at=23611 \|year=2014 \|doi=10.3402/gha.v7.23611 \|pmid=24560265 \|pmc=PMC3926986}}</ref> 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.<ref name="LiuGlobal17">{{cite journal \|title=Global Health Workforce Labor Market Projections for 2030 \|journal=Human Resources for Health \|author=Liu, J.X.; Goryakin, Y.; Maeda, A. et al. \|volume=15 \|issue=1 \|at=11 \|year=2017 \|doi=10.1186/s12960-017-0187-2 \|pmid=28159017 \|pmc=PMC5291995}}</ref> Laboratory medicine makes no exception to this rule, since inefficient turnover has involved almost each category of laboratory professionals, especially during the past decade.<ref name="Cortelyou-WardTheLab11">{{cite journal \|title=The laboratory workforce shortage: A managerial perspective \|journal=The Health Care Manager \|author=Cortelyou-Ward, K.; Ramirez, B.; Rotarius, T. \|volume=30 \|issue=2 \|pages=148–55 \|year=2011 \|doi=10.1097/HCM.0b013e318216f5df \|pmid=21537137}}</ref> 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.<ref name="LippiCost18" /><ref name="LippiTheAdd17">{{cite journal \|title=The add value of laboratory diagnostics: The many reasons why decision-makers should actually care \|journal=Journal of Laboratory and Precision Medicine \|author=Lippin, G.; Plebani, M. \|volume=2 \|issue=12 \|at=100 \|year=2017 \|doi=10.21037/jlpm.2017.12.07}}</ref> 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.<ref name="ChasinMedic07">{{cite journal \|title=Medical errors arising from outsourcing laboratory and radiology services \|journal=American Journal of Medicine \|author=Chasin, B.S.; Elliott, S.P.; Klotz, S.A. \|volume=120 \|issue=9 \|pages=e9-11 \|year=2007 \|doi=10.1016/j.amjmed.2006.07.024 \|pmid=17765055}}</ref> 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.<ref name="LacknerTheTheran16">{{cite journal \|title=The Theranos phenomenon, scientific transparency and freedom of speech \|journal=Clinical Chemistry and Laboratory Medicine \|author=Lackner, K.J.; Gillery, P.; Lippi, G. et al. \|volume=54 \|issue=9 \|pages=1403-5 \|year=2016 \|doi=10.1515/cclm-2016-0520 \|pmid=27442369}}</ref>

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	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).<ref name="LippiLab12">{{cite journal \|title=Laboratory networking and sample quality: A still relevant issue for patient safety \|journal=Clinical Chemistry and Laboratory Medicine \|author=Lippi, G.; Simundic, A.M. \|volume=50 \|issue=10 \|pages=1703–5 \|year=2012 \|doi=10.1515/cclm-2012-0245 \|pmid=23089698}}</ref><ref name="LukićLab17">{{cite journal \|title=Laboratory Information System - Where are we Today? \|journal=Journal of Medical Biochemistry \|author=Lukić, V. \|volume=36 \|issue=3 \|pages=220-224 \|year=2017 \|doi=10.1515/jomb-2017-0021 \|pmid=30564059 \|pmc=PMC6287214}}</ref> 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.<ref name="PlebaniDriving19">{{cite journal \|title=Driving the route of laboratory medicine: A manifesto for the future \|journal=Internal and Emergency Medicine \|author=Plebani, M.; Laposata, M;. Lippi, G. \|volume=14 \|issue=3 \|pages=337–40 \|year=2019 \|doi=10.1007/s11739-019-02053-z \|pmid=30783946}}</ref> 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.		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).<ref name="LippiLab12">{{cite journal \|title=Laboratory networking and sample quality: A still relevant issue for patient safety \|journal=Clinical Chemistry and Laboratory Medicine \|author=Lippi, G.; Simundic, A.M. \|volume=50 \|issue=10 \|pages=1703–5 \|year=2012 \|doi=10.1515/cclm-2012-0245 \|pmid=23089698}}</ref><ref name="LukićLab17">{{cite journal \|title=Laboratory Information System - Where are we Today? \|journal=Journal of Medical Biochemistry \|author=Lukić, V. \|volume=36 \|issue=3 \|pages=220-224 \|year=2017 \|doi=10.1515/jomb-2017-0021 \|pmid=30564059 \|pmc=PMC6287214}}</ref> 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.<ref name="PlebaniDriving19">{{cite journal \|title=Driving the route of laboratory medicine: A manifesto for the future \|journal=Internal and Emergency Medicine \|author=Plebani, M.; Laposata, M;. Lippi, G. \|volume=14 \|issue=3 \|pages=337–40 \|year=2019 \|doi=10.1007/s11739-019-02053-z \|pmid=30783946}}</ref> 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.<ref name="LippiLabHemo18">{{cite journal \|title=Laboratory hemostasis: From biology to the bench \|journal=Clinical Chemistry and Laboratory Medicine \|author=Lippi, G., Favaloro, E.J. \|volume=56 \|issue=7 \|pages=1035–45 \|year=2018 \|doi=10.1515/cclm-2017-1205 \|pmid=29455188}}</ref> 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<ref name="JørgensenLeader17">{{cite journal \|title=Leadership and Management in Clinical Biochemistry \|journal=Journal of Medical Biochemistry \|author=Jørgensen, P.E. \|volume=36 \|issue=3 \|pages=216–19 \|year=2017 \|doi=10.1515/jomb-2017-0023 \|pmid=30564058 \|PMC=PMC6287210}}</ref>, principles of cost-effectiveness<ref name="LippiCost18">{{cite journal \|title=Cost, profitability and value of laboratory diagnostics: In God we trust, all others bring data \|journal=Journal of Laboratory Medicine \|author=Lippi, G.; Plebani, M. \|volume=43 \|issue=1 \|pages=1–3 \|year=2018 \|doi=10.1515/labmed-2018-0321}}</ref>, and pre-analytical requirements.<ref name="LippiNovel17">{{cite journal \|title=Novel Opportunities for Improving the Quality of Preanalytical Phase. A Glimpse to the Future? \|journal=Journal of Medical Biochemistry \|author=Lippi, G., Cadamuro, J. \|volume=36 \|issue=4 \|pages=293-300 \|year=2017 \|doi=10.1515/jomb-2017-0029 \|pmid=30581325 \|pmc=PMC6294089}}</ref> 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 laboratory\|Lean management]] systems, which contextually enable to maximize efficiency and create a culture of [[Continual improvement process\|continuous improvement]].<ref name="KnowlesLean13">{{cite journal \|title=Lean laboratories: Laboratory medicine needs to learn from other industries how to deliver more for less \|journal=Journal of Clinical Pathology \|author=Knowles, S.; Barnes, I. \|volume=66 \|issue=8 \|pages=635–7 \|year=2013 \|doi=10.1136/jclinpath-2013-201624 \|pmid=23681948}}</ref> The leading factors associated with this process are volume and complexity (i.e., capacity), equipment and utility lists, staffing model, work schedule, [[Regulatory compliance\|regulatory considerations]], safety ergonomic requirements, and, given space availability, research and education considerations (i.e., in academic centers).

			==Step 3 - Staff availability and qualification==

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	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.		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).<ref name="LippiLab12">{{cite journal \|title=Laboratory networking and sample quality: A still relevant issue for patient safety \|journal=Clinical Chemistry and Laboratory Medicine \|author=Lippi, G.; Simundic, A.M. \|volume=50 \|issue=10 \|pages=1703–5 \|year=2012 \|doi=10.1515/cclm-2012-0245 \|pmid=23089698}}</ref><ref name="LukićLab17">{{cite journal \|title=Laboratory Information System - Where are we Today? \|journal=Journal of Medical Biochemistry \|author=Lukić, V. \|volume=36 \|issue=3 \|pages=220-224 \|year=2017 \|doi=10.1515/jomb-2017-0021 \|pmid=30564059 \|pmc=PMC6287214}}</ref> 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.<ref name="PlebaniDriving19">{{cite journal \|title=Driving the route of laboratory medicine: A manifesto for the future \|journal=Internal and Emergency Medicine \|author=Plebani, M.; Laposata, M;. Lippi, G. \|volume=14 \|issue=3 \|pages=337–40 \|year=2019 \|doi=10.1007/s11739-019-02053-z \|pmid=30783946}}</ref> 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.



	==References==		==References==

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	==Introduction==		==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.<ref name="LippiTheIrr19">{{cite journal \|title=The Irreplaceable Value of Laboratory Diagnostics: Four Recent Tests that have Revolutionized Clinical Practice \|journal=EJIFCC \|author=Lippi, G. \|volume=30 \|issue=1 \|pages=7–13 \|year=2019 \|pmid=30881270 \|pmc=PMC6416815}}</ref> 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<ref name="LippiWeigh18">{{cite journal \|title=Weighting healthcare efficiency against available resources: value is the goal \|journal=Diagnosis \|author=Lippi, G. \|volume=5 \|issue=2 \|pages=39–40 \|year=2018 \|doi=10.1515/dx-2018-0031 \|pmid=29858902}}</ref>, which has also obligated [[laboratory]] managers to increase volume and complexity of testing, contextually preserving [[Quality (business)\|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<ref name="Majkić-SinghLab17">{{cite journal \|title=Laboratory Medicine Management: Leadership Skills for Effective Laboratory \|journal=Journal of Medical Biochemistry \|author=Majkić-Singh, N. \|volume=36 \|issue=3 \|pages=207–10 \|year=2017 \|doi=10.1515/jomb-2017-0034 \|pmid=30564056 \|pmc=PMC6287220}}</ref>, budgeting activities<ref name="PriceTrans18">{{cite journal \|title=Translational health economics: The key to accountable adoption of in vitro diagnostic technologies \|journal=Health Services Management Research \|author=Price, C.P.; Wolstenholme, J.; McGinley, P. et al. \|volume=31 \|issue=1 \|pages=43–50 \|year=2018 \|doi=10.1177/0951484817736727 \|pmid=29084478}}</ref> and, last but not least, project management.		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.<ref name="LippiTheIrr19">{{cite journal \|title=The Irreplaceable Value of Laboratory Diagnostics: Four Recent Tests that have Revolutionized Clinical Practice \|journal=EJIFCC \|author=Lippi, G. \|volume=30 \|issue=1 \|pages=7–13 \|year=2019 \|pmid=30881270 \|pmc=PMC6416815}}</ref> 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<ref name="LippiWeigh18">{{cite journal \|title=Weighting healthcare efficiency against available resources: value is the goal \|journal=Diagnosis \|author=Lippi, G. \|volume=5 \|issue=2 \|pages=39–40 \|year=2018 \|doi=10.1515/dx-2018-0031 \|pmid=29858902}}</ref>, which has also obligated [[laboratory]] managers to increase volume and complexity of [[Medical test\|testing]], contextually preserving [[Quality (business)\|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<ref name="Majkić-SinghLab17">{{cite journal \|title=Laboratory Medicine Management: Leadership Skills for Effective Laboratory \|journal=Journal of Medical Biochemistry \|author=Majkić-Singh, N. \|volume=36 \|issue=3 \|pages=207–10 \|year=2017 \|doi=10.1515/jomb-2017-0034 \|pmid=30564056 \|pmc=PMC6287220}}</ref>, budgeting activities<ref name="PriceTrans18">{{cite journal \|title=Translational health economics: The key to accountable adoption of in vitro diagnostic technologies \|journal=Health Services Management Research \|author=Price, C.P.; Wolstenholme, J.; McGinley, P. et al. \|volume=31 \|issue=1 \|pages=43–50 \|year=2018 \|doi=10.1177/0951484817736727 \|pmid=29084478}}</ref> 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). 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, and the acknowledgement of staff availability and qualification, along with the establishment of a positive and constructive interplay with [[hospital]] administrators.		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).

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			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 [[Laboratory automation\|automation]] of several steps throughout the total testing process<ref name="HawkerNon17">{{cite journal \|title=Nonanalytic Laboratory Automation: A Quarter Century of Progress \|journal=Clinical Chemistry \|author=Hawker, C.D. \|volume=63 \|issue=6 \|pages=1074-1082 \|year=2017 \|doi=10.1373/clinchem.2017.272047 \|pmid=28396562}}</ref>, 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 [[Sample (material)\|samples]] in the laboratory to their final discharge or storage once testing has been completed.<ref name="GenzenChall18">{{cite journal \|title=Challenges and Opportunities in Implementing Total Laboratory Automation \|journal=Clinical Chemistry \|author=Genzen, J.R.; Burnham, C.D.; Felder, R.A. et al. \|volume=64 \|issue=2 \|pages=259–64 \|year=2018 \|doi=10.1373/clinchem.2017.274068 \|pmid=28971983}}</ref> 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 [[Interface (computing)\|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.<ref name="LippiAdvant19">{{cite journal \|title=Advantages and limitations of total laboratory automation: A personal overview \|journal=Clinical Chemistry and Laboratory Medicine \|author=Lippi, G.; Da Rin, G. \|volume=57 \|issue=6 \|pages=802–11 \|year=2019 \|doi=10.1515/cclm-2018-1323 \|pmid=30710480}}</ref> 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 [[Medical diagnosis\|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.

	==References==		==References==

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	==Introduction==		==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.<ref name="LippiTheIrr19">{{cite journal \|title=The Irreplaceable Value of Laboratory Diagnostics: Four Recent Tests that have Revolutionized Clinical Practice \|journal=EJIFCC \|author=Lippi, G. \|volume=30 \|issue=1 \|pages=7–13 \|year=2019 \|pmid=30881270 \|pmc=PMC6416815}}</ref> 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<ref name="LippiWeigh18">{{cite journal \|title=Weighting healthcare efficiency against available resources: value is the goal \|journal=Diagnosis \|author=Lippi, G. \|volume=5 \|issue=2 \|pages=39–40 \|year=2018 \|doi=10.1515/dx-2018-0031 \|pmid=29858902}}</ref>, which has also obligated [[laboratory]] managers to increase volume and complexity of testing, contextually preserving [[Quality (business)\|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<ref name="Majkić-SinghLab17">{{cite journal \|title=Laboratory Medicine Management: Leadership Skills for Effective Laboratory \|journal=Journal of Medical Biochemistry \|author=Majkić-Singh, N. \|volume=36 \|issue=3 \|pages=207–10 \|year=2017 \|doi=10.1515/jomb-2017-0034 \|pmid=30564056 \|pmc=PMC6287220}}</ref>, budgeting activities<ref name="PriceTrans18">{{cite journal \|title=Translational health economics: The key to accountable adoption of in vitro diagnostic technologies \|journal=Health Services Management Research \|author=Price, C.P.; Wolstenholme, J.; McGinley, P. et al. \|volume=31 \|issue=1 \|pages=43–50 \|year=2018 \|doi=10.1177/0951484817736727 \|pmid=29084478}}</ref> and, last but not least, project management.		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.<ref name="LippiTheIrr19">{{cite journal \|title=The Irreplaceable Value of Laboratory Diagnostics: Four Recent Tests that have Revolutionized Clinical Practice \|journal=EJIFCC \|author=Lippi, G. \|volume=30 \|issue=1 \|pages=7–13 \|year=2019 \|pmid=30881270 \|pmc=PMC6416815}}</ref> 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<ref name="LippiWeigh18">{{cite journal \|title=Weighting healthcare efficiency against available resources: value is the goal \|journal=Diagnosis \|author=Lippi, G. \|volume=5 \|issue=2 \|pages=39–40 \|year=2018 \|doi=10.1515/dx-2018-0031 \|pmid=29858902}}</ref>, which has also obligated [[laboratory]] managers to increase volume and complexity of testing, contextually preserving [[Quality (business)\|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<ref name="Majkić-SinghLab17">{{cite journal \|title=Laboratory Medicine Management: Leadership Skills for Effective Laboratory \|journal=Journal of Medical Biochemistry \|author=Majkić-Singh, N. \|volume=36 \|issue=3 \|pages=207–10 \|year=2017 \|doi=10.1515/jomb-2017-0034 \|pmid=30564056 \|pmc=PMC6287220}}</ref>, budgeting activities<ref name="PriceTrans18">{{cite journal \|title=Translational health economics: The key to accountable adoption of in vitro diagnostic technologies \|journal=Health Services Management Research \|author=Price, C.P.; Wolstenholme, J.; McGinley, P. et al. \|volume=31 \|issue=1 \|pages=43–50 \|year=2018 \|doi=10.1177/0951484817736727 \|pmid=29084478}}</ref> 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). 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, and the acknowledgement of staff availability and qualification, along with the establishment of a positive and constructive interplay with [[hospital]] administrators.

			{\|
			\| STYLE="vertical-align:top;"\|
			{\| class="wikitable" border="1" cellpadding="5" cellspacing="0" width="100%"
			\|-
			\| style="background-color:white; padding-left:10px; padding-right:10px;" colspan="2"\|'''Table 1.''' The six paradigms of project management in laboratory medicine
			\|-
			\|-
			! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"\|Paradigm
			! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"\|Description
			\|-
			\| style="background-color:white; padding-left:10px; padding-right:10px;"\|Efficiency
			\| style="background-color:white; padding-left:10px; padding-right:10px;"\|To achieve maximum laboratory productivity with minimum wasted effort or expense
			\|-
			\| style="background-color:white; padding-left:10px; padding-right:10px;"\|Efficacy
			\| style="background-color:white; padding-left:10px; padding-right:10px;"\|To achieve better diagnoses and improved clinical outcomes
			\|-
			\| style="background-color:white; padding-left:10px; padding-right:10px;"\|Quality
			\| style="background-color:white; padding-left:10px; padding-right:10px;"\|To develop the highest possible degree of reliability and safety in test results
			\|-
			\| style="background-color:white; padding-left:10px; padding-right:10px;"\|Safety
			\| style="background-color:white; padding-left:10px; padding-right:10px;"\|To limit the risk of injury or damage to patients and laboratory staff
			\|-
			\| style="background-color:white; padding-left:10px; padding-right:10px;"\|Sustainability
			\| style="background-color:white; padding-left:10px; padding-right:10px;"\|To avoid depleting human and economic resources
			\|-
			\| style="background-color:white; padding-left:10px; padding-right:10px;"\|Satisfaction
			\| style="background-color:white; padding-left:10px; padding-right:10px;"\|To fulfill both laboratory staff and stakeholders’ (i.e., patients’, doctors’) wishes, expectations, and needs
			\|-
			\|}
			\|}

	==References==		==References==

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{{Infobox journal article
|name =
|image =
|alt = 
|caption =
|title_full = Project management in laboratory medicine
|journal = ''Journal of Medical Biochemistry''
|authors = Lippi, Guiseppe; Mattiuzi, Camilla
|affiliations = University of Verona, Provincial Agency for Social and Sanitary Services (Trento, Italy)
|contact = Email: giuseppe dot lippi at univr dot it
|editors =
|pub_year = 2019
|vol_iss = '''38'''(4)
|pages = 401–6
|doi = [https://doi.org/10.2478/jomb-2019-0021 10.2478/jomb-2019-0021]
|issn = 1452-8266
|license = [https://creativecommons.org/licenses/by-nc-nd/4.0/ Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International]
|website = [https://content.sciendo.com/configurable/contentpage/journals$002fjomb$002f38$002f4$002farticle-p401.xml https://content.sciendo.com/contentpage/]
|download = [https://content.sciendo.com/downloadpdf/journals/jomb/38/4/article-p401.xml https://content.sciendo.com/downloadpdf/journals/jomb/38/4/article-p401.xml] (PDF)
}}
{{ombox
| type = notice
| image = [[Image:Emblem-important-yellow.svg|40px]]
| style = width: 500px;
| text = This article should be considered a work in progress and incomplete. Consider this article incomplete until this notice is removed.
}}
==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 [[Laboratory automation|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.<ref name="LippiTheIrr19">{{cite journal |title=The Irreplaceable Value of Laboratory Diagnostics: Four Recent Tests that have Revolutionized Clinical Practice |journal=EJIFCC |author=Lippi, G. |volume=30 |issue=1 |pages=7–13 |year=2019 |pmid=30881270 |pmc=PMC6416815}}</ref> 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<ref name="LippiWeigh18">{{cite journal |title=Weighting healthcare efficiency against available resources: value is the goal |journal=Diagnosis |author=Lippi, G. |volume=5 |issue=2 |pages=39–40 |year=2018 |doi=10.1515/dx-2018-0031 |pmid=29858902}}</ref>, which has also obligated [[laboratory]] managers to increase volume and complexity of testing, contextually preserving [[Quality (business)|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<ref name="Majkić-SinghLab17">{{cite journal |title=Laboratory Medicine Management: Leadership Skills for Effective Laboratory |journal=Journal of Medical Biochemistry |author=Majkić-Singh, N. |volume=36 |issue=3 |pages=207–10 |year=2017 |doi=10.1515/jomb-2017-0034 |pmid=30564056 |pmc=PMC6287220}}</ref>, budgeting activities<ref name="PriceTrans18">{{cite journal |title=Translational health economics: The key to accountable adoption of in vitro diagnostic technologies |journal=Health Services Management Research |author=Price, C.P.; Wolstenholme, J.; McGinley, P. et al. |volume=31 |issue=1 |pages=43–50 |year=2018 |doi=10.1177/0951484817736727 |pmid=29084478}}</ref> and, last but not least, project management.

==References==
{{Reflist|colwidth=30em}}

==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.


[[Category:LIMSwiki journal articles (added in 2020)‎]]
[[Category:LIMSwiki journal articles (all)‎]]
[[Category:LIMSwiki journal articles on laboratory medicine]]