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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


WWW.PATHOLOGYINPRACTICE.COM MAY 2024


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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