LABORATORY MANAGEMENT PRE-ANALYTICAL Tube delivery ANALYTICAL Load balancing
Inventory and
onboard reagent status
POST-ANALYTICAL Recapping preparation
Storage rack
Retrieval
Delivery to instruments (re-run,
reflex, etc) Fig 1. The stages of the laboratory operational process.
automation, where the analysers dedicated to different types of tests, (clinical chemistry, immunochemistry, haematology, haemostasis, etc), performed on different sample matrixes (whole blood, serum, heparinated or citrate plasma), are physically connected and integrated into modular systems or physically connected by transportation lines.
In the more complex TLA systems,
all pre-analytical and post-analytical steps, (check-in, sorting, de-capping, centrifugation, separation, aliquoting, sealing, and archiving), are performed automatically by workstations physically connected to the analysers and managed by a dedicated middleware connected to the laboratory’s LIS.
Defining the automation project Starting from the initial planning phase, both decision makers and stakeholders need to be aware of what the objectives of the automation project are. These goals must, of course, be specific, measurable and achievable within the budget allocated to the whole project. Therefore, laboratory managers must have a holistic view of the entire process to decide what working model needs to be adopted and what technologies will enable the predetermined objectives to be achieved. The inability to adequately assess the needs of the laboratory and
to understand the current state and processes of the laboratory are two key reasons why many automation projects are not successful.
The decision to initiate a program
of reorganisation of analytical activities through the adoption of an automation system requires the drafting of a proper project plan, and therefore it is necessary to appoint an internal figure, within the laboratory itself, to be entrusted with the duties of a project manager. In addition to managing all phases of the project until its completion, the project manager is responsible for supporting the laboratory director’s decisions and coordinating departments, such as the hospital’s information technology, administration, and clinical engineering, as well as reporting on progress to all parties and stakeholders involved in the project.
It is then necessary to establish an open dialogue with technology manufacturers and suppliers in order to obtain the most comprehensive solution that best suits the needs of the laboratory. Most major automation system suppliers employ dedicated automation experts who can work closely with the laboratory staff and the project manager to get the most out of new technology platforms. The project manager must take a systematic approach in defining the
One of the objectives of automation is to increase the number of automated operations, reduce those that will necessarily remain manual, and identify those related to data management that can be entrusted to software and middleware systems
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automation project, considering, in particular, the following aspects: n mapping the workflow, volumes and timelines
n identifying potential bottlenecks n analysis of current and future needs and expectations
n available space and structural characteristics of the laboratory
n process logistics (collecting and transporting specimen tubes, sending results and reports, tubes archiving and retrieval, etc.).
n impact on the temperature of the areas designated for the automation system
n possible technological solutions to achieve the project objectives
n evaluate alternatives available from major automation system suppliers (distinguished between ‘closed’ and ‘open’ systems suppliers)
n key performance indicators (KPIs) to track project progress and effectiveness
n defining a transition plan, how laboratory service will be guaranteed during installation
n defining a contingency plan, in case of stop or failure of the automation system
n overall economic analysis of the project (balancing costs and benefits).
Workflow mapping is among the first key activities in drafting the project. The following four steps are mandatory: 1. processes mapping: to identify and represent the component activities and the relationships between them;
2. quantitative data collection from each individual activities: to identify process trends, weaknesses, low added-value activities and where resources are wasted;
3. design of the new process: to describe 33
Disposal of samples
Manual operations Automated operations
Data-management system operations
Instrument status
QC status
Dilution control
Repeat testing
Reflex testing
validation Test
Results review
Post-sorting Processing Data entry
Bench sorting
Pre-analytic delivery
Pre-sorting Aliquoting Decapping
Racking tubes
Delivery to instruments
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