Journal:Project management in laboratory medicine

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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.[1] 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[2], 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[3], budgeting activities[4] 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 1. 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[5], 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.[6] 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.[7] 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).[8][9] 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.[10] 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.[11] 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[12], principles of cost-effectiveness[13], and pre-analytical requirements.[14] 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.[15] 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.[16] 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.[17] Laboratory medicine makes no exception to this rule, since inefficient turnover has involved almost each category of laboratory professionals, especially during the past decade.[18] 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.[13][19] 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.[20] 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.[21]

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.[22] 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.[23]

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

Several lines of evidence now attest that role and responsibilities of laboratory managers have considerably evolved over the last few decades.[24] These paradigm shifts have been mostly driven by clinical, technical, economic, and social factors, mainly encompassing deepened understanding of the pathophysiology of human diseases, technological innovations, renewed focus on patient safety, cost-containment strategies, and patient empowerment.

The most obvious consequence has been the development of an ongoing process of reorganization, consolidation, and automation of laboratory services. The effective realization of those services requires defining an efficient project management plan, as well as constructing a new consciousness and an innovative and multifaceted job description of laboratory professionals worldwide. Notably, some other important drivers and outcome measures shall be considered when restructuring or redesigning the layout of a laboratory service, as briefly summarized in Table 2. These essentially include the identification and management of potential political or ideological resistances to the changes; the need to share the strategic plan with laboratory staff, local authorities, syndicates, and stakeholders (i.e., clinicians and patients); the definition of reliable performance indicators (both qualitative and quantitative), which will help assessing as to whether the new project is efficient and effective; and continuous monitoring of staff and stakeholder satisfaction.

Table 2. Leading drivers of project management in laboratory medicine
Step 1 - Defining the environment

a. Define space availability and organization.
b. Identify the most suitable local model of laboratory automation.

Step 2 – Planning technical resources

a. Define the geographical context ("hub" or "spoke" laboratory).
b. Recognize local clinical educational and research needs.
c. Identify predicted volume and complexity of tests.
d. Develop clinical-laboratory liaison and diagnostic stewardship.
e. Take advantage of using a Lean management system.

Step 3 – Staff availability and qualification

a. Define the number of available persons.
b. Acknowledge technical and clinical qualification of the staff.
c. Adapt volume and complexity of testing to available staff.
d. Identify critical issues in staff regulations (e.g., time on turn, recovery).
e. Place the right person in the right place for doing the right activity at the right time.
f. Safeguard personnel and patient safety.

Step 4 – Interplay with hospital administration

a. Seek out a constructive dialogue with hospital administrators.
b. Acknowledge the local political context.
c. Be aware of local healthcare plans (e.g., reorganization of healthcare network, number of beds, evolution of case-mix).
d. Become familiar with administrative duties and budgeting processes.

Step 5 – Additional drivers

a. Identify political or ideological resistances to the changes.
b. Share the strategic plan with laboratory staff, local authorities, syndicates, and stakeholders (i.e., clinicians and patients).
c. Define reliable performance indicators (qualitative and quantitative).
d. Continuously monitor staff and stakeholders satisfaction.
e. Identify an alternative solution (i.e., a backup plan).
f. Publicize results (when successful).

Finally, additional consideration must be made. For example, common experience teaches that the delineation of an alternative solution—should the primary solution not come to fruition—may certainly be helpful to overcome possible technical failures of a new project. Whenever possible, the switch from the old to the new laboratory layout—especially when entailing the use of novel instrumentation—should not be irreversible. Additionally, the two solutions should be allowed to run in parallel for a certain period of time, at least until most of the possible problems have been identified and solved. Last but not least, provided that the final project proves successful, results must be publicized so that others may take profit from the local translation of favorable outcomes.

Acknowledgements

This article is a detailed summary of an oral presentation delivered during the 15th Belgrade Symposium for Balkan Region, Belgrade (Serbia), 11–12 April, 2019.

Conflict of interest

The authors state that they have no conflicts of interest regarding the publication of this article.

References

  1. ↑ Lippi, G. (2019). "The Irreplaceable Value of Laboratory Diagnostics: Four Recent Tests that have Revolutionized Clinical Practice". EJIFCC 30 (1): 7–13. PMC PMC6416815. PMID 30881270. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6416815. 
  2. ↑ Lippi, G. (2018). "Weighting healthcare efficiency against available resources: value is the goal". Diagnosis 5 (2): 39–40. doi:10.1515/dx-2018-0031. PMID 29858902. 
  3. ↑ Majkić-Singh, N. (2017). "Laboratory Medicine Management: Leadership Skills for Effective Laboratory". Journal of Medical Biochemistry 36 (3): 207–10. doi:10.1515/jomb-2017-0034. PMC PMC6287220. PMID 30564056. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6287220. 
  4. ↑ Price, C.P.; Wolstenholme, J.; McGinley, P. et al. (2018). "Translational health economics: The key to accountable adoption of in vitro diagnostic technologies". Health Services Management Research 31 (1): 43–50. doi:10.1177/0951484817736727. PMID 29084478. 
  5. ↑ Hawker, C.D. (2017). "Nonanalytic Laboratory Automation: A Quarter Century of Progress". Clinical Chemistry 63 (6): 1074-1082. doi:10.1373/clinchem.2017.272047. PMID 28396562. 
  6. ↑ Genzen, J.R.; Burnham, C.D.; Felder, R.A. et al. (2018). "Challenges and Opportunities in Implementing Total Laboratory Automation". Clinical Chemistry 64 (2): 259–64. doi:10.1373/clinchem.2017.274068. PMID 28971983. 
  7. ↑ Lippi, G.; Da Rin, G. (2019). "Advantages and limitations of total laboratory automation: A personal overview". Clinical Chemistry and Laboratory Medicine 57 (6): 802–11. doi:10.1515/cclm-2018-1323. PMID 30710480. 
  8. ↑ Lippi, G.; Simundic, A.M. (2012). "Laboratory networking and sample quality: A still relevant issue for patient safety". Clinical Chemistry and Laboratory Medicine 50 (10): 1703–5. doi:10.1515/cclm-2012-0245. PMID 23089698. 
  9. ↑ Lukić, V. (2017). "Laboratory Information System - Where are we Today?". Journal of Medical Biochemistry 36 (3): 220-224. doi:10.1515/jomb-2017-0021. PMC PMC6287214. PMID 30564059. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6287214. 
  10. ↑ Plebani, M.; Laposata, M;. Lippi, G. (2019). "Driving the route of laboratory medicine: A manifesto for the future". Internal and Emergency Medicine 14 (3): 337–40. doi:10.1007/s11739-019-02053-z. PMID 30783946. 
  11. ↑ Lippi, G., Favaloro, E.J. (2018). "Laboratory hemostasis: From biology to the bench". Clinical Chemistry and Laboratory Medicine 56 (7): 1035–45. doi:10.1515/cclm-2017-1205. PMID 29455188. 
  12. ↑ Jørgensen, P.E. (2017). "Leadership and Management in Clinical Biochemistry". Journal of Medical Biochemistry 36 (3): 216–19. doi:10.1515/jomb-2017-0023. PMC PMC6287210. PMID 30564058. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6287210. 
  13. ↑ 13.0 13.1 Lippi, G.; Plebani, M. (2018). "Cost, profitability and value of laboratory diagnostics: In God we trust, all others bring data". Journal of Laboratory Medicine 43 (1): 1–3. doi:10.1515/labmed-2018-0321. 
  14. ↑ Lippi, G., Cadamuro, J. (2017). "Novel Opportunities for Improving the Quality of Preanalytical Phase. A Glimpse to the Future?". Journal of Medical Biochemistry 36 (4): 293-300. doi:10.1515/jomb-2017-0029. PMC PMC6294089. PMID 30581325. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6294089. 
  15. ↑ Knowles, S.; Barnes, I. (2013). "Lean laboratories: Laboratory medicine needs to learn from other industries how to deliver more for less". Journal of Clinical Pathology 66 (8): 635–7. doi:10.1136/jclinpath-2013-201624. PMID 23681948. 
  16. ↑ Aluttis, C.; Bishaw, T.; Frank, M.W. (2014). "The workforce for health in a globalized context--global shortages and international migration". Global Health Action 7: 23611. doi:10.3402/gha.v7.23611. PMC PMC3926986. PMID 24560265. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3926986. 
  17. ↑ Liu, J.X.; Goryakin, Y.; Maeda, A. et al. (2017). "Global Health Workforce Labor Market Projections for 2030". Human Resources for Health 15 (1): 11. doi:10.1186/s12960-017-0187-2. PMC PMC5291995. PMID 28159017. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5291995. 
  18. ↑ Cortelyou-Ward, K.; Ramirez, B.; Rotarius, T. (2011). "The laboratory workforce shortage: A managerial perspective". The Health Care Manager 30 (2): 148–55. doi:10.1097/HCM.0b013e318216f5df. PMID 21537137. 
  19. ↑ Lippin, G.; Plebani, M. (2017). "The add value of laboratory diagnostics: The many reasons why decision-makers should actually care". Journal of Laboratory and Precision Medicine 2 (12): 100. doi:10.21037/jlpm.2017.12.07. 
  20. ↑ Chasin, B.S.; Elliott, S.P.; Klotz, S.A. (2007). "Medical errors arising from outsourcing laboratory and radiology services". American Journal of Medicine 120 (9): e9-11. doi:10.1016/j.amjmed.2006.07.024. PMID 17765055. 
  21. ↑ Lackner, K.J.; Gillery, P.; Lippi, G. et al. (2016). "The Theranos phenomenon, scientific transparency and freedom of speech". Clinical Chemistry and Laboratory Medicine 54 (9): 1403-5. doi:10.1515/cclm-2016-0520. PMID 27442369. 
  22. ↑ Plebani, M.; Laposata, M.; Lippi, G. (2019). "A manifesto for the future of laboratory medicine professionals". Clinica Chimica Acta 489: 49–52. doi:10.1016/j.cca.2018.11.021. PMID 30445032. 
  23. ↑ Horvath, A.R. (2013). "From evidence to best practice in laboratory medicine". Clinical Biochemist Reviews 34 (2): 47–60. PMC PMC3799219. PMID 24151341. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3799219. 
  24. ↑ Jassam, N.; Lake, J.; Dabrowska, M. et al. (2018). "The European Federation of Clinical Chemistry and Laboratory Medicine syllabus for postgraduate education and training for Specialists in Laboratory Medicine: Version 5 - 2018". Clinical Chemistry and Laboratory Medicine 56 (11): 1846–63. doi:10.1515/cclm-2018-0344. PMID 29870392. 

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.

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