Accepted Manuscript Project management: importance for diagnostic laboratories Antony Croxatto, Gilbert Greub PII: S1198-743X(17)30212-4 DOI: 10.1016/j.cmi.2017.04.007 Reference: CMI 919 To appear in: Clinical Microbiology and Infection Received Date: 17 February 2017 Revised Date: 1 April 2017 Accepted Date: 6 April 2017 Please cite this article as: Croxatto A, Greub G, Project management: importance for diagnostic laboratories, Clinical Microbiology and Infection (2017), doi: 10.1016/j.cmi.2017.04.007. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
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Accepted Manuscript
Project management: importance for diagnostic laboratories
Antony Croxatto, Gilbert Greub
PII: S1198-743X(17)30212-4
DOI: 10.1016/j.cmi.2017.04.007
Reference: CMI 919
To appear in: Clinical Microbiology and Infection
Received Date: 17 February 2017
Revised Date: 1 April 2017
Accepted Date: 6 April 2017
Please cite this article as: Croxatto A, Greub G, Project management: importance for diagnosticlaboratories, Clinical Microbiology and Infection (2017), doi: 10.1016/j.cmi.2017.04.007.
This is a PDF file of an unedited manuscript that has been accepted for publication. As a service toour customers we are providing this early version of the manuscript. The manuscript will undergocopyediting, typesetting, and review of the resulting proof before it is published in its final form. Pleasenote that during the production process errors may be discovered which could affect the content, and alllegal disclaimers that apply to the journal pertain.
management competence center, funding ..), and manufacturers (Lab automation specialists). 172
2.1.4 Objectives 173
It is common to say that the goals of a project must be SMART – specific, measurable, 174
assignable, realistic and time-based [4]. However, the SMART acronym does not have one single 175
specific meaning since different words definitions within the acronym have been used over time. 176
The project has to be well defined (specific), success criteria must be measurable with indicators 177
(table 1) to monitor the progression of the project and to find out when the goal will be achieved 178
(measurable), people belonging to the project have to be specified with a common agreement on 179
the goal of a project (assignable, agreed upon), results that can be realistically achieved with the 180
available human, financial and material resources must be stated (realistic, reasonable), and time-181
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based to specify when the results will be achieved (time-based, enough time to achieve the goal 182
of a project but not too much time which could alter the expected performance). 183
For instance, success criteria of the project on full automation of the laboratory of 184
bacteriology and hygiene could include the following measurable indicators: percentage of total 185
samples inoculated automatically, percentage of total plates read by telebacteriology [3], 186
percentage of total antibiotic susceptibility testing processed by the system, reliability of the 187
system, time to report identification as well as time to report antibiotic susceptibility testing and 188
technician working time per sample (productivity). The objectives should also define the 189
expected results (often named gain of the project) that can be measurable. In case of a diagnostic 190
laboratory, they could include several essential items such as decreased turn-around-time, 191
increased quality, increased productivity and decreased full time equivalent (table 1). 192
2.1.5 Organization 193
The organization (hierarchy) involved in the project needs to be determined and should 194
comprise the core organization, the structure to which the project sponsor and users are affiliated, 195
and the project organization which is a temporary organization existing only from project 196
approval and closing. The project organization does not have to comply with the core 197
organization hierarchy, but has to describe the different roles involved in a project and its 198
different tasks, responsibilities and activities. As mentioned in change management, the project 199
organization should encompass a powerful guiding coalition to achieve a project successfully. 200
Moreover, the different partners involved in a project, and thus the project organization, may 201
change throughout the project according to the different phases and tasks planned in the project. 202
Based on the HERMES model, the project organization is divided in three layers, (1) the steering, 203
(2) the management and (3) the execution [2]. The steering includes the sponsor and the project 204
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committee who have to control that the project objectives are fulfilled and that the different 205
deadlines are met, the management includes the project manager, the technical committee and if 206
required the subproject manager who are in charge to prepare, manage and close the project. The 207
execution includes specialists that will take care of the tasks and their outcomes (figure2). The 208
project organization will also provide the basis to estimate the human resources that will be 209
required to achieve the project successfully. 210
2.2 Conception 211
The first major aspect is the characterization of the laboratory needs based on a detailed 212
analysis of its activity and organization. The activity has to be defined with multiple parameters 213
including inoculation and incubation protocols, samples/plates volumes and distribution (hourly, 214
daily, and weekly), samples growth trends, FTEs, media, containers and LIS specifications. 215
Secondly, a good knowledge on laboratory automation in bacteriology is required to understand 216
the systems and better characterized their advantages, requirements, limits and future evolutions 217
[3, 5-13]. This can be achieved through contact with manufacturers and with users, factories 218
visits, literature and congress attendance. All these informations represent the backbone for a 219
thorough analysis of manufacturer’s propositions and a smart choice of an automated solution. 220
These data will also assist the project manager and project steering committee to distinguish 221
between mandatory and optional needs, according to the budget of a project. Moreover, detailed 222
analysis and good knowledge of the automated systems are essentials to perform an optimal risk 223
analysis, since a failure of the project may be caused by an inadequate analysis of the laboratory 224
activities (under- or overestimation of the laboratory needs) or by a lack of knowledge of the 225
automated systems (wrong expectations). 226
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2.3 Implementation-Deployment 227
The product is chosen and detailed system, technical, laboratory and LIS specification can be 228
determined. The preparation of the installation of an automated system in the laboratories has to 229
be conducted, including (1) identification and allocation of human resources, (2) architectural and 230
technical adaptation of the premises, (3) planning of the organization of the routine laboratory 231
activities before, during and after installation which may require a temporal recruitment of 232
additional technicians, (4) specification of the connection of the automated system with the 233
laboratory LIS (LIS interface development), (5) set-up of the configuration of the automated 234
system and test of functionality at the factory facility, (6) training of the users with workshop 235
organized by the manufacturers and (7) change management. The implementation phase 236
represents the launching pad of the deployment and the quality of the preparation will determine 237
the success of the installation and the quality of the final product of the project. During the 238
deployment phase, the automated system is installed and activated. The general functionality and 239
configuration are tested. Then, the go-live of the system can be initiated with continuous 240
improvement of the laboratory workflow through testing several validation processes. This task is 241
performed in parallel to conventional approaches until most of the samples are processed 242
automatically, introducing thus suboptimal working conditions with different sample analysis 243
processes (manual versus automated) and reduced working areas. A follow-up of the success 244
criteria indicators is performed and risks including system failures and staff commitment are 245
carefully analyzed. Thus, this phase can be time-consuming, stressing and long lasting and a 246
careful change management should be followed by the project manager. 247
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2.3.1 Change management 248
The success of a project is dependent on both the quality of the project and on the acceptance 249
of the idea by all the individuals that are directly or indirectly involved in the project. The vision 250
of a project needs to be shared with the entire staff of the laboratory. John P. Kotter identified 251
eight errors that may cause a project failure due to inappropriate change management: (1) too 252
much self-satisfaction, (2) failure to create a powerful guiding coalition, (3) underestimating the 253
power of vision, (4) a lack of communication of the vision, (5) leaving obstacles blocking the 254
new vision, (6) failure to obtain short-term wins, (7) shouting victory too early and (8) neglecting 255
to anchor the new approaches in the culture of the employees [14]. The project manager needs 256
thus to communicate his/her vision of a project. Not knowing what is going to happen is bringing 257
anxiety, fear of the future and resistance. The project manager needs to convince all the partners 258
or should modify his vision in order to create a guiding coalition that rally every person involved 259
in the project. To do so, the project manager relies on the line management, especially the project 260
sponsor, that needs to provide a strong support to the project manager by ensuring that resources 261
and disciplinary commitments are provided by the entire organization. A regular and frequent 262
communication program has to be implemented to report the progression of the project including 263
encountered successes and difficulties. It is also productive to involve the laboratory staff in the 264
future re-organization of the laboratory activities following laboratory automation installation. 265
Moreover, a complete training program of the staff prior to reception of the automated system 266
will help to decrease the anxiety due to the inexperience of using such a new tool. The aim is 267
clearly to arrange a transition from resistance to commitment to generate a teamwork that will 268
maximize the success of a project [15]. A poor change management may generate several 269
counterproductive issues such as staff resistance, no adaptation to automation, productivity and 270
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quality loss, staff escape and conflicts escalation. In the worst case, a significant project failure or 271
interruption may be caused by a poor change management. 272
3 Risk analysis 273
The risk is part of a project because a project is by definition introducing a notion of novelty, 274
innovation not previously experienced. In addition, the size of the project with its level of 275
complexity (technical, organizational and human) will directly influence the risks. Thus a risk 276
analysis has to be conducted in every phases of a project. A methodology to analyze the risk has 277
to be implemented to identify, evaluate, address and manage the risks. Failure mode and effects 278
analysis (FMEA) methodology described the risk index (RI) = probability (P) x severity (S) x 279
detection (D) [16]. The probability describes the likelihood of occurrence of a failure, the severity 280
characterizes the impact of a failure and the detection describes how easy or difficult it is to 281
identify a failure. Thus, the higher the risk index the more attention should be addressed to the 282
activity impacted by the risk. Risk analysis tables can be used to identify, evaluate and address 283
the risks of a project (table 2). It is recommended to list the measures of mitigation to minimize 284
or prevent the risk, or if the risk occurs, measures of contingency in order to manage and solve 285
the problems. Moreover, a person in charge of risk management needs to be clearly identified. 286
These measures should ensure that most of the problems that could affect the project are quickly 287
and appropriately managed. 288
4 Conclusions 289
This review presented a general overview of project and change management with an 290
emphasis on selected critical aspects. A structured project management conducted by an efficient 291
project manager is required to achieve the goals and to meet the success criteria of complex 292
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projects such as laboratory automation. Such projects involving and impacting multiple partners 293
and organizational entities require a structured supervision and monitoring of all the tasks and 294
activities to achieve successfully a project with optimal performance, costs control and respect of 295
time-limit. With the increasing complexities of modern laboratories, clinical microbiologists 296
should use current management tools to improve the outcome of their major projects, project and 297
change management being essential parts of their activities. 298
Figures legends 299
Figure 1. Project phases with examples of tasks and activities that could be defined in a 300
project of automation of a laboratory of bacteriology. Each phase is delimited by milestones 301
representing security gates ensuring the appropriate progression of the project, allowing or not a 302
phase release to the next phase based on phase reports of the project manager. However, 303
additional multiple project status reports should be performed during each phase of the project 304
from the project management to the steering and the core organization. The project starts upon 305
acceptance of a business plan by the core organization and ends with a final project evaluation. 306
Adapted from HERMES 5 [2]. 307
Figure 2. Project organization of the automation of the laboratory of bacteriology and 308
hygiene of the CHUV. The business plan acceptation is only including the core organization 309
whereas the project is involving the core and project organization. According to the HERMES 5 310
model [2], the project organization is characterized by three layers, the steering, the management 311
and the execution. The specialists (automation specialists, microbiologists, IT and LIS specialists, 312
technicians, architects, manufacturers) will take care of the tasks and their outcomes. 313
314
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Transparency declaration 315
Dr. Croxatto and Prof. Greub have nothing to disclose. No external funding was received. 316
References 317
1 Munns AK, Bjeirmi BF. The role of project management in achieving project success. 318 International Journal of Project Management. 1996; 14: 81-87. 319
2 FITSU. Hermes 5. 2017. http://www.hermes.admin.ch/index.xhtml 320 3 Croxatto A, Prod'hom G, Faverjon F, Rochais Y, Greub G. Laboratory automation in 321
clinical bacteriology: What system to choose? Clin Microbiol Infect. 2016; 22: 217-235. 322 4 Doran GT. There's a s.M.A.R.T. Way to write management's goals and objectives. 323
Management Review. 1981; 70: 35-36. 324 5 Croxatto A, Dijkstra K, Prod'hom G, Greub G. Comparison of inoculation with the 325
inoqula and wasp automated systems with manual inoculation. J Clin Microbiol. 2015; 326 53: 2298-2307. 327
6 Dauwalder O, Landrieve L, Laurent F, de Montclos M, Vandenesch F, Lina G. Does 328 bacteriology laboratory automation reduce time to results and increase quality 329 management? Clin Microbiol Infect. 2016; 22: 236-243. 330
7 Froment P, Marchandin H, Vande Perre P, Lamy B. Automated versus manual sample 331 inoculations in routine clinical microbiology: A performance evaluation of the fully 332 automated inoqula instrument. J Clin Microbiol. 2014; 52: 796-802. 333
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9 Hombach M. Wasplab improves precision, reproducibility and enables real-time kirby-336 bauer ast. Copan workshop at 25th European Congress of Clinical Microbiology and 337 Infectious Disease 2015. 338
10 Mischnik A, Mieth M, Busch CJ, Hofer S, Zimmermann S. First evaluation of automated 339 specimen inoculation for wound swab samples by use of the previ isola system compared 340 to manual inoculation in a routine laboratory: Finding a cost-effective and accurate 341 approach. J Clin Microbiol. 2012; 50: 2732-2736. 342
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ACCEPTED MANUSCRIPTTable 1. Excerpt of a project charter of « full lab automation »
1. Name of the project Automation of the laboratory of bacteriology including inoculation, incubation and telebacteriology 2. Context (origin, history, signification, cause…)
• Sample increase of about 6% each year • Personal shortages • Recently introduced solutions (automated inoculation system and MALDI-TOF) and previous laboratory
reorganization not enough to absorb the increasing number of samples. • Laboratory consolidation (bacteriology and hygiene) • New laboratory • ….
3. Project scope (Partners and needs) • Laboratory of bacteriology and hygiene • Laboratory department • Biomedical engineers • IT specialists (LIS) • Administration and general direction • Manufacturers • …..
4. Objectives of the project Global final results Indicators of success criteria Functional automated system (inoculation, incubation and telebacteriology)
• ≥ 80 % of samples inoculated automatically • ≥ 95 % of plates read through telebacteriology • ≥ 98 % reliability • …..
Results or gain of the project (quantitative and qualitative)
5. Phases of the project See figure 1 Initiation, concept, implementation and deployment 6. Time-limit of the project (estimation) August 2017 7. Risks analysis See table 2 Identification, evaluation, processing and management 8. Organization (hierarchy) See figure 2 Core organization (executive board,..) Project organization
Project chart System characterization and selection
�System requirements�Detailed general analysis�Contact with manufacturers�Factories visits �Lab workflow analysis�Risk analysis�Public tender�Selection of an automated system�Contract �Phase report