WO2022175919A1

WO2022175919A1 - A system and a process for control, traceability and automation of laboratory analysis processes and/or clinical or diagnostic testing

Info

Publication number: WO2022175919A1
Application number: PCT/IB2022/051536
Authority: WO
Inventors: Davide Carlo Alberto PEDRAZZINI
Original assignee: Pedrazzini Davide Carlo Alberto
Priority date: 2021-02-22
Filing date: 2022-02-22
Publication date: 2022-08-25
Also published as: IT202100004067A1

Abstract

A system (1) for control, traceability and automation of laboratory analysis processes and/or clinical or diagnostic testing comprises in a work/process area: one or more workstations or process islands (2) in data communication with a central computer control unit (E) and having means for carrying out laboratory analysis and/or clinical or diagnostic testing on samples (T) and one or more mobile units (3) suitable to receive, carry and deliver samples or resources (T) from at least one input workstation to at least one output workstation of said system (1) and from and to one or more workstations or process islands (2), preferably: - each mobile unit (3) can be selectively interfaced/coupled with said one or more workstations or process islands (2) to deliver and/or receive samples or resources (T) to be processed or already processed in said one or more workstations or process islands (2); - each mobile unit (3) is equipped with an electronic control unit (E1) in operative communication with said central computer control unit (E) and - to each mobile unit (3) moving means (4) and a detection and guide system (406, E2) in operative communication with said central computer control unit (E) are associated.

Description

“A system and a process for control, traceability and automation of laboratory analysis processes and/or clinical or diagnostic testing”

DESCRIPTION

Field of the invention

The present invention concerns a system and a process for control, traceability and automation of laboratory analysis processes and/or clinical or diagnostic testing, being furthermore possible to use such system and such process even in the field of industrial, food farming or research processes, and the mobile units used in such a system.

For simplicity of exposure, this description is given by way of non-limiting example with specific reference to laboratory analysis processes and/or clinical or diagnostic testing, with the clarification that the expression "diagnostic testing" is used to also include anatomical pathological analyses and the like.

Prior Art

In the field processes such as laboratory analysis and/or clinical or diagnostic testing, there is a strong need to ensure the so-called "Chain of Custody" of all the transported material (both biological and other samples), as well as of the information and resources used in the various steps of the process, in order to:

- guarantee the best features of process traceability, flexibility and repeatability together with operational excellence and slenderness;

- guarantee the presence and conservation of all the information accompanying the analysis processes carried out, including the time and conditions of transport, treatment and conservation; - guarantee the possibility of identifying further opportunities for improving the process as well as its inefficiencies or problems.

Furthermore, it is necessary to have processes as automated as possible in order to guarantee a complete traceability of the processes and, above all, the correctness and consistency of the operations carried out in the aforementioned processes, conditions that cannot be guaranteed for processes carried out manually by one or more users.

It is indeed necessary to highlight how, nowadays, there is a strong need to be able to manage, use and address in the most appropriate way the variety of formats of samples, instrumentation and consumable products involved in these processes, as well as the activity of the subjects involved in these processes in order to avoid possible errors, creating a control platform of the processes which, in addition to being flexible, must also be easily reconfigurable to adapt to any new requests.

At the same time it is necessary to consider the need to be able not only to simplify but above all to speed up the processing time of the samples, as well as the need to optimize and vary in an almost immediate way the sequence and order in which the various samples must be processed according to specific temporary needs.

On this point it should be considered that the systems and process for the control, traceability and automation of laboratory analysis processes and/or clinical or diagnostic testing currently used are not able to fully satisfy the aforementioned needs. In fact, such known systems are based on an architecture in which several workstations or process islands are positioned in predetermined points of the system layout and are served/fed in sequence with the various samples to be processed through conventional conveyors/transporters, i.e. belt or magnetic.

However, this kind of architecture has some drawbacks, first of all that of not being able to let a sample to be processed pass from a first processing station to another non-contiguous processing station, except by transporting the various samples in sequence according to the predetermined path given by the arrangement of the conveyors/transporters provided in the system.

Moreover, with known systems of the type indicated above:

- it is not easy to implement a variation of the structure, for example with the addition of a new workstation able to carry out different type of tests, since the architecture of the system is rigid and its change requires to be well planned in the design phase and also takes a long time to be implemented;

- it is not possible to guarantee a complete supply chain and traceability of the various samples during transport between the various workstations, for example as it concerns the preservation conditions of the samples during transport, and

- it is not possible to speed up the timing of laboratory, clinical or diagnostic testing since the transport time of the various samples is an unavoidable waste of time.

Furthermore, at the end of the performed cycles of operations or analyses, it is often found that the workflow, made up of the expected cycles of operations and analyses for each individual sample, is not the most suitable for one or more specific samples.

Object of the invention

The object of the present invention is to optimize the operative and information flow of the processes ensuring the full and complete traceability of the samples, resources, components and information involved through all the steps of the processes themselves, even during the transport steps of the aforementioned samples, resources, components or information.

A further object is to generate a so-called "Digital Twin" system capable of reliably ensuring the association and correspondence of the data of the digital model with those of the real process, also allowing an easy communication of information and parameters of the process itself to all the actors involved or interested, but anyway authorized.

A further object is to speed up the process operations on the various samples as much as possible, allowing, where required, to carry out at least part of the process steps during the transport steps, for example as it concerns pre- or post- analytical operations.

A further object of the invention is to allow the system and the process to be released from the presence of rigid and predetermined transport paths for samples and process resources, therefore differently from what nowadays can be found in systems that provide for the use of conveyors/transporters to carry out the handling of samples within the system.

A further object of the invention is to allow to transport the samples and process resources according to a path that can be modified and redefined according to the needs that may arise from time to time, in particular so as to make the samples travel the shortest path from the starting point to the arrival point and to simplify the interface means between the transport units and the workstations able to carry out further process steps.

A further object is to vary with maximum flexibility the expected workflow for each sample or resource, updating and rescheduling from time to time for each sample or resource the workflow still to be performed on the basis and/or according to the results of the operations or analyses already carried out on the sample or resource itself or on samples or resources related to it.

In this view, another object of the invention is to be able to disregard the conformation of the work space, i.e. the size and arrangement of objects, rooms or walls in the environment, making the system applicable in a simple and almost immediate way with any conformation of the working environment.

Moreover, this answers to the need, nowadays increasingly felt, to make different process specialties coexist in a single work space and therefore to standardize the ways of taking charge and transport of samples or resources, regardless of their features and the type of processing to which they must undergo.

On this point it should be noted that in the context of the present invention the expressions "work space" and "environment or work/process area" must be understood broadly and not limited to the physical boundaries of a room or an environment, for example having “environments or work/process areas” or “work spaces” that extend over several rooms of a building, as well as over several levels or floors of a building or a plurality of independent buildings.

Not the least object of the invention is to propose a modular, scalable and easily reconfigurable solution according to the needs, possibly modifying if necessary the number and/or composition both of the structures used for the transport of samples and resources and of those used for the processing of the same, according to the specific needs of each application and also taking into account possible emergency situations (e.g. a sample or a resource being processed which, in view of a request for in-depth analysis, must be recalled in a station where it has already been processed).

It also falls within the objects of the invention to provide a system and a process which allow a flexible programming of the activities still to be carried out, also intended as the possibility of updating/rescheduling the activities still to be carried out on the individual samples, for example in order to favor a specific activity over another, in different periods of the day.

Furthermore, it falls within the object of the invention to create a system and a process for the control, traceability and automation of processes and specialties that can be adapted to applications even very different from each other, favoring their integration.

The problem underlying the present invention is therefore that of satisfying the aforementioned objects and, at the same time, of satisfying the aforementioned needs, meanwhile solving the problems of the systems and process for control, traceability and automation of processes referred to in relation to the prior art.

According to the invention, such problem is solved by a system according to claim 1.

According to a further aspect, such technical problem is also solved by a process for the control, traceability and automation of processes according to claim 11.

Brief description of the figures

Further features and advantages of the invention will be evident from the following description, provided by way of non-limiting example with reference to the following figures:

- figure 1 is a schematic plan view of a work/process environment of the system in accordance with the present invention;

- figure 2 is a perspective and schematic view of a first embodiment of a mobile transport unit of samples or resources according to the present invention; - figure 3 is a schematic view in longitudinal section of the mobile transport unit of figure 2;

- figure 4 shows a schematic view from the bottom of a possible configuration of a transport unit according to the invention;

- figure 5 illustrates a schematic plan view of an example of the interfacing system between a mobile unit and an interface unit and

- figure 6 shows a side elevation view of the interfacing system between a mobile unit and an interface unit of figure 5.

Detailed description of the invention

With reference to the above figures, number 1 generally indicates a system according to the invention for control, traceability and automation of laboratory analysis processes and/or clinical or diagnostic testing.

The system 1 allows to move and process different samples or resources T, some inserted within containers, to submit them to the necessary and foreseen operations, processes, analyses and/or inspections at one or more workstations or process islands 2, as well as to submit them to a possible series of further pre- analytical and/or post-analytic operations before and/or after the aforementioned operations, processes, analyses and/or inspections, as it will be better detailed below in the description.

For this purpose, the system 1 comprises means for moving samples or resources T in a work/process area toward, from and between said one or more workstations or process islands 2 and/or loading/unloading points of said system 1. As will become clearer from the rest of the present description, said means comprise one or more mobile units 3.

It is specified that, in the context of the present invention, the term "resources" is used in a generic mood to mark elements such as, for example, reagents, drugs and the like, as well as elements of any other type functional to be moved in the work/process environment (in combination or not with the samples to be examined) and therefore to undergo appropriate processing even if not a real analysis.

By way of example, it should be noted that, according to a certainly non- exhaustive list, possible pre-analytic and/or post-analytic operations may include:

- reading of codes such as Bar-code/QR code;

- reading of RFID tags;

- reading and visual recognition of colors or shapes (for example the color of the cap of a test tube, for identification of the biological material);

- de-sealing, opening and/or re-closure of test tubes or sample containers;

- evaluations and determination of volumes, for example of a serum;

- evaluation of HIL index (Hemolysis/Icterus/Lipemia) and

- dynamic treatment of samples, for example by centrifugation.

In accordance with the embodiment shown in figure 1, the system 1 comprises a series of workstations or process islands 2 arranged along the perimeter of the working environment, as well as loading/unloading points of samples or resources T.

It is clear that such arrangement is illustrated here purely by way of example, since the extreme operative flexibility of the system according to the invention allows to operate with a layout of any type, being for example also possible to provide for the presence of workstations in a central area of the working environment, without any limit.

The aforementioned one or more workstation or process islands 2 are made up of single workstations or islands formed by several workstations grouped together and, once a specific layout of the system 1 has been established, such one or more workstation or process islands 2 generally remain fixed within the working environment until the need arises to modify the layout thereof to meet new process requirements or to improve the workflow of the samples or T resources to be processed.

It should be noted that, although in the example of figure 1 the work/ process environment, or work space, is a flat environment limited by a perimeter wall equipped with openings to allow the entry and exit of samples or resources T to be processed or already processed, as well as the means used to move samples or resources T, the work/process environment, or work space, can be much larger than that depicted in figure 1, being able to extend to more rooms, contiguous or spaced apart, of a building, as well as on several levels or floors of a building or a plurality of independent buildings, each equipped with loading/unloading points.

The aforementioned one or more workstations or process islands 2 are generally connected and wired to the structure of the work environment to receive, according to an example list, power supply, data wiring, lighting, water, compressed air, technical gases and/or other services according to specific needs, as well as they can be connected to liquid and/or solid waste networks.

Moreover, as will be seen in more detail in the following of the present description, in one of its preferred embodiments, the system is also able to flexibly adapt to the layout of the working environment, modifying the positions or functions of the one or more workstations or process islands 2 according to the operating cycle to be followed.

System 1 includes a central computer control unit E, which can be physically present in the proximity of the working environment or can operate remotely, for example according to a cloud solution.

The one or more workstations or process islands 2 are in data communication with the aforementioned central computer control unit E in order to receive and provide information on the laboratory analysis processes or clinical or diagnostic testing to be carried out and on the results of such analysis or testing. As will become clearer from the following description, this allows said central computer control unit E to selectively update/reschedule the operations or analyses still to be carried out for each individual sample or resource T on the basis and/or according to the results of operations or analyses already carried out on said sample or resource T in said one or more workstations or process islands 2, or on samples or resources T related to it.

The aforementioned one or more workstations or process islands 2 are equipped with means for carrying out laboratory analysis and/or clinical or diagnostic testing on samples to be examined.

Furthermore, the system 1 comprises means for moving samples or resources T in the work/process area toward, from and between the aforementioned one or more workstations or process islands 2, all under the supervision and control of the central computer control unit E which supervises the operation of the system 1 according to the invention.

In particular, it should be noted that the aforementioned workstations or process islands 2 are in data communication with the central computer control unit E in order to receive information on where to bring samples or resources T to be processed or already processed and, possibly, to receive information regarding the pre-analysis, analysis or post-analysis processes to be carried out on such samples or resources, as will become clearer from the rest of this description.

Advantageously, the aforementioned means for moving samples or resources T within the work/process area comprise one or more mobile units 3, each of which is arranged to receive, transport and deliver samples or resources T from at least one input station to at least one output station of the system 1, as well as from and to one or more workstations or process islands 2.

Each mobile unit 3 can be selectively interfaced/coupled with the aforementioned workstations or process islands 2 to deliver and/or receive samples or resources T to be processed or already processed in the aforementioned one or more workstations or process islands 2.

Each mobile unit 3 is equipped with an electronic control unit El in operative communication with the central computer control unit E.

Each mobile unit 3 is associated with moving means 4 and a detection and guide system 406, E2 in operative communication with the central computer control unit E.

It should be noted that the central computer control unit E is designed and programmed to supervise the operation of each mobile unit 3 and to control the free movement of each mobile unit 3 within the work/process area according to a path which is free and flexibly modifiable by said central computer control unit E depending on the predetermined cycle of operations and analyses according to which it is convenient to process in the aforementioned one or more workstations or process islands 2 the specific samples or resources T aboard each mobile unit 3.

Therefore, the workflow of each specific sample or resource can be modified/rescheduled in a flexible way by said central computer control unit E on the basis and/or according to the results of the operations or analyses already carried out on said sample or resource T in said one or more workstations or process islands 2, or on samples or resources T related to it.

Preferably, the aforementioned one or more mobile units 3 are also processing units of samples or resources T, being for this purpose equipped with one or more operating modules Ml, M2, M3, M4, M5, M6 to submit the transported samples or resources T to one or more process operations during transport and/or stay aboard the mobile units 3.

Preferably, the aforementioned operating modules Ml, M2, M3, M4, M5, M6 of the mobile units 3 are operating modules for performing pre-analysis, analysis and/or post-analysis operations and/or processes on samples or resources T present on board, before said samples or resources T are delivered to a workstation or process island 2 to undergo other working or processing, or after the samples or resources T have been returned to a mobile unit 3.

Preferably, each mobile unit 3 comprises an output U for samples or resources T to be delivered to a workstation or process island 2, an input I to receive samples or resources T returning from a workstation or process island 2 and also comprises, by way of example, one or more of the following modules:

- an input module Ml for receiving the samples or resources T to be fed toward successive modules of the mobile unit 3;

- a module M2 for reading, preferably for optical reading, an identification code with which the samples or resources T to be processed are uniquely identified, said module M2 for reading being in operative communication, via an on board electronic unit El, with the central computer control unit E, to transmit the code detected on each sample or resource T;

- a module M3 for manipulating said samples or resources T, such as for example the unwinding or rewinding of a protective film;

- a module M6 for removing and/or applying a sealing cap to the container in which samples or resources T to be processed or processed are contained;

- a singularization module;

- a transport module M4, for transporting samples or resources T from said input module Ml, through the successive operating modules to said output U, for delivery of the samples or resources T to a workstation or process island 2, and

- a transport module M5 for transporting samples or resources T that return into the mobile unit 3 through said input I, said transport device M5 being suitable to return said samples or resources T again to the aforementioned output U for delivery to a successive workstation or process island 2 or to a final storage unit 6.

According to an embodiment not shown in the figures, the aforementioned moving means and the detection and guide system in operative communication with the central computer control unit are fully integrated aboard each mobile unit.

Differently, according to the preferred embodiment illustrated in the figures, the aforementioned moving means 4 are only partially integrated aboard each mobile unit 3. Specifically, the aforementioned moving means 4 associated with each mobile unit 3 comprise:

- first moving means 11, 12, 13, 21, Ml, M3, M4, M5, M6 integrated aboard each mobile unit 3 for moving and manipulating samples or resources T in the mobile unit itself and/or for delivering/receiving samples or resources T to be processed or already processed in said one or more workstations or process islands 2 and

- second moving means comprising self-propelled transport units 40 which can be selectively and releasably coupled with a respective mobile unit 3 to move said respective mobile unit 3 within the work/process area, also having regard that the aforementioned detection and guide system 406, E2 is mounted aboard each of said self-propelled transport units 40.

Preferably, in accordance with the embodiment illustrated in the figures:

- each mobile unit 3 has a containing structure 300 having support feet 301 for resting on a floor 100 of said work/process area and an elevated rear wall which extends as a bridge with respect to the support surface of said support feet 301 and, at the same time,

- each self-propelled transport unit 40 is identified by an autonomous mobile robot equipped with a coupling mechanism 400 provided with a lifting device, said robot 40 being configured such that it can be arranged below the elevated bridge rear wall of the mobile unit 3, to lift the mobile unit 3 from the floor of the work area and make it transportable.

Preferably, the system 1 comprises an interface unit 9 for each of the aforementioned one or more workstations or process islands 2, said interface unit 9 being configured to operatively and selectively couple the workstation or process island 2 with a respective mobile unit 3 in order to enable an automated transfer of a sample or a resource from the mobile unit 3 to the workstation or process island 2, and vice versa.

Preferably, each interface unit 9 comprises a first interface portion 9A outwardly facing to interface in a standard manner with said mobile units 3 and a second opposite adapter portion 9B configured according to the specific features of the respective workstation or process island 2 with which it is associated.

It should be noted that the expression "interface in a standard manner" used above with reference to the first interface portion 9A, is used to indicate that the configuration, at a hardware and/or software level, is substantially always of the same type, so as to allow a correct interfacing between the mobile units 3 and the various workstations or process islands 2 regardless of the specific mobile unit 3 and workstation or process island 2 considered.

Differently, the aforementioned adapter portion 9B is customized according to the specific structural and functional features, both in terms of hardware and software, of each workstation or process island 2.

Further construction details of the interfacing between the mobile unit 3 and the interface unit 9 are highlighted in figures 5 and 6. In particular in figure 6 it is highlighted a possible configuration, both of the mobile unit 3 and of the interface portion 9A, which provides for the housing of samples or resources T on several levels in height, in order to accommodate a greater number of them and therefore optimize the available spaces. The ascent or descent of the aforementioned samples or resources T can be managed by means of a handling apparatus.

Preferably, each mobile unit 3 is associated with at least one sensor/detector device 333 which is connected to its respective on board electronic control unit El and is able of reporting to the central computer control unit E an information on the position of the specific mobile unit 3, the central computer control unit E being programmed to obtain an information on the position of each mobile unit 3 on the basis of an information on the initial position of the mobile unit 3 and a memorization of all the movements of the mobile unit 3 itself, whether or not coupled to a self-propelled transport unit 40.

Preferably, each mobile unit 3 is equipped with at least one rechargeable electric battery B 1 for supplying power to electrical components carried aboard said mobile unit 3, for example the modules M1-M6 if they require voltage and current to be supplied.

In figure 1, the system 1 comprises three mobile units 3 each arranged to receive, transport and deliver samples or resources T, which in the case of the work area illustrated in figure 1 provide for some operations or processing that can be carried out within the mobile units 3 themselves, and others that must be carried out at the workstations or process islands 2 distributed along the work area figure 1 shows by way of example a mobile unit 3 while it is moving within the system 1 along a programmable path in a dynamic and flexible way in the previously defined meaning, and two further mobile units 3 which are in a waiting condition in two peripheral parking positions provided in the system 1. As described above, all the mobile units 3 are in communication with the central computer control unit E.

Still figure 1 illustrates by way of example the presence of four transport units 40, each equipped with its own detection and guide system, one of which is coupled to a mobile unit 3 during transport.

For the purposes of the present invention, a particularly advantageous embodiment of transport unit 40 is that constituted by an autonomous mobile robot (AMR). AMRs are totally autonomous vehicles, equipped with an on board system for sensing the surrounding environment and driving the vehicle. Typically an AMR comprises one or more motorized wheels, at least one directional wheel and/or one or more pivoting wheels. The electronic control unit which is aboard the AMR is in communication with the central computer control unit E, so that the central computer control unit E is constantly informed about the position of the AMR and can reprogram in real time the movement thereof, updating/rescheduling it in order to determine or modify the task and the path followed by each AMR according to the different circumstances, in particular on the basis or according to: the results of the operations or analyses already carried out on said samples or resources T in one or more workstations or process islands 2 and/or the results of one or more operations and/or processes already carried out on samples or resources T in one or more operating modules Ml, M2, M3, M4, M5, M6 during transport and/or stay aboard the one or more mobile units 3, in particular:

• updating/rescheduling the operations or analyses still to be carried out on each individual sample or resource T and/or

• updating/rescheduling the path and the destination of the single mobile units 3 within the work/process area between the various workstations or process islands.

Still according to a technique known per se, each AMR is equipped with safety systems to detect the presence of obstacles and in particular the presence of operators within the work area, so as to be able to stop to avoid any accidental impact, or to follow alternative paths in order to get around the obstacle.

Figure 4 schematically shows an exemplary form of the means for moving samples or resources T in the work/process area toward, from and between said one or more workstations or process islands 2. According to the illustrated embodiment, these means comprise a mobile transport robot 40 comprising a structure 403 mounted on two motorized and steering wheels R1 and on two idle pivoting wheels R2. An electric motor 404 to control the rotation of the wheel, and an electric motor 405 to control the steering of the wheel are associated with each wheel Rl. The motors 404, 405 are powered by a rechargeable electric battery B, under the supervision of an on board electronic unit E2, to which a communication module Cl in operative communication with the central computer control unit E is associated. The mobile transport robot 40 is equipped with a series of sensor/detector devices 406 of any known type, for example in the form of LIDAR devices and/or radar devices and/or satellite tracking devices, and/or emitting devices cooperating with stationary reflectors arranged in various points of the work area in the system 1, which allow the mobile transport robot 40 to detect the surrounding environment. All of the aforementioned devices are powered by the battery B and are connected to the on board electronic unit E2.

An example of a removable coupling between a mobile unit 3 and a transport unit 40 (for example an Autonomous Mobile Robot or AMR) is shown in figure 2. As can be seen in this figure, which is given here purely by way of example, the mobile unit 3 comprises a containing structure 300 having support feet 301 (only one of which is visible in figure 2) for resting on the floor 100 of the work area. The containing structure 300 has a rear wall whose bottom surface 302 extends as a bridge with respect to the resting surface defined by the feet 301. In this way, between the support feet 301 a space 303 opening onto opposite sides of the structure 300 is defined , into which a transport unit 40 can be inserted. The transport unit 40 is equipped with a coupling mechanism comprising an upper liftable platform 400 (figure 2 shows an extended guard 401 which connects the perimeter of the liftable platform 400 with the perimeter of the lower structure of the transport unit 40) in order to take charge of the structure 300 of the mobile unit 3 above itself. Figure 2 shows the condition in which the transport unit 40 is inserted into the space 303 and the upper platform 400 has been raised so as to distance the support feet 301 of the structure 300 from the floor 100 for a distance D. In this condition, the transport unit 40 is thus capable of transporting the mobile unit 3 within the work space 1. Preferably, not only the transport units 40, but also the mobile units 3 are equipped with at least one sensor/detector device 333 (schematically shown in figure 3) of any known type (for example in the form of a satellite locator or, still for example, in the form of an emitter cooperating with stationary reflectors arranged in the laboratory) connected to the electronic control unit El (schematically illustrated in figure 3) aboard the mobile unit 3, to constantly communicate to the central computer control unit E the information on the position of the mobile unit 3. Alternatively, the position detector devices can be only associated with the transport units 40 and the central control unit E obtains the information on the position of each mobile unit 3 as it knows and stores the information on the initial position of each mobile unit 3, the association of each mobile unit 3 with a transport unit 40 and all the movements of each transport unit 40 associated with a mobile unit 3.

The electronic units El, E2 aboard the mobile units 3 and the transport units 40 are in turn in operative communication with the central computer control unit E, to allow the latter not only to control the movement of the transport units 40 during their task, but also to control a docking operation between a transport unit 40 and a mobile unit 3, or a decoupling operation of a transport unit 40 from a mobile unit 3.

Still with reference to figure 1, the lines with arrow indicated by the reference number 5 illustrate, purely by way of example, a path that the transport unit 40 coupled with the mobile unit 3 is intended to follow, in order to take the mobile unit 3 to subsequently interface with the different workstations or process islands 2. The aforementioned path ends at a storage unit 6, arranged in a peripheral area of the work/process area of the system 1, from which the samples or resources T are subsequently routed toward an exit of the laboratory or an adjacent room or building, for example with the aid of an automated line of any known type or by means of manual operations. Similarly, the work area of the system 1 has an input station 8 of the samples or resources T toward which they are routed, for example by means of an automated line of any known type or by manual operations.

In accordance with the embodiment described and illustrated above, the input station 8 and the storage unit 6 identify possible loading/unloading points of the work/process area of the system 1.

With reference to the embodiment illustrated in figure 1, the work/process area is also equipped with an opening 30 through which to allow the passage of the mobile units 3 and/or the transport units 40.

Figure 2 illustrates, purely by way of example, an embodiment of a mobile unit 3. In the case of this embodiment, the mobile unit 3 has a containing structure 300 having the configuration already described above, able for receiving the transport unit 40 in the space 303 provided below the bottom surface 302 of the structure 300.

It is of course possible to provide for any different configuration of the coupling mechanism 400 which couples the mobile unit 3 to the transport unit 40. For example it can also be provided that the containing structure 300 of the mobile unit 3 is a structure mounted on idle and pivoting wheels, and that the transport unit 40 is equipped with a coupling device, cooperating with a corresponding coupling member arranged on the structure 300, for pulling the mobile unit 3.

Each mobile unit 3 includes one or more operating modules, to submit the taken over samples or resources T to a series of operations and/or processing before and/or after they are handed over to one or more workstations or process islands 2 for further processing. With reference in particular to figure 3, the mobile unit 3 of the illustrated example comprises first of all an input module Ml including an intake point 10, open on a side wall of the structure 300, through which the samples or resources T are fed in bulk, for example within a hopper 11. An elevator device 12 rises from the bottom of the hopper 11, which is able to singularize the samples or resources by transporting them separately and in succession upwards up to a chute 13.

The construction details of the hopper 11 and of the elevator device 12 are not further described here, since these operating modules are "commercial objects" which can be purchased on the free market.

In the embodiment herein illustrated, it is expected that each sample or resource has an identification code, associated for example with the process to be performed. The samples or resources that have reached the top of the elevator device 12 are carried in succession, through the chute 13, to a further module M2 comprising an optical reader device, of any known type, for the optical reading of the identification code shown on the sample or resource. The optical reader M2 is in operative communication with the central computer control unit E, via the on board electronic unit El, to transmit the detected code to each sample or resource.

Still with reference to the example illustrated in Figure 2, the mobile unit 3 can further comprise a transport module M4 containing a conveyor device of any known type, for example a chain conveyor, for transporting the samples or resources in succession to an output U of the mobile unit 3 through which they are delivered to a workstation or process island 2. Inside the structure 300 of the mobile unit 3 there is a module M3 for manipulating the sample or resource which can perform further operations and/or processing on the sample or resource, potentially working together with other operating modules/ tools/sensors such as for example a computer vision system for inspection/verification/control of the operations of the manipulation module M3, while the mobile unit 3 is selectively coupled to the transport unit 40 and is moving toward a successive workstation or process island 2.

When a sample or resource T has finished the process step within a specific workstation or process island 2, it is returned by the station or island 2, through the interface unit 9, to an input I (figure 2) with which the mobile unit 3 is equipped. The sample or resource T slides into the opening of the input I via a chute 19 or any other known process. Once returned within the mobile unit 3, the sample or resource is transported again, by means of a transport module M5 of any known type, to the output U, possibly after further operations by the manipulator module, in order to be delivered to a successive workstation or process island 2 or to the unit 6 for its storage.

Preferably, the upper wall of the mobile unit 3 is also equipped with a door 20 (figure 2) which is able to open to allow the exit of a device 21 (schematically illustrated in figure 3) for picking up the sample or resource, each time that it must be quickly removed from the mobile unit 3 or inserted into the transport circuit within the mobile unit 3.

Obviously the construction details of the operating modules arranged within the mobile unit 3, of the transport line of the samples or resources within the mobile unit 3, of the input I and the output U through which the mobile unit exchanges samples or resources with one or more workstations are here provided purely by way of non-limiting example, being evident that these construction aspects can widely vary, depending on the needs of each specific application.

According to a further possible feature of the invention, it can be provided that even one or more of the workstations or process islands 2 are configured to be transported/moved, in exceptional circumstances.

As already indicated above, thanks to this feature, the system according to the invention also allows the layout of the work area to be quickly reconfigured, for example during a night break in order to optimally adapt such layout to the specific cycle of operations that is expected. In other words, the system according to the invention allows a very high operational flexibility as it allows the layout of the work area to be redesigned in a simple and rapid way according to any changes in the tasks for which such area is intended.

Maximum operational flexibility is naturally also obtained with reference to the path that each mobile unit 3 follows within the work area. The path followed by a specific mobile unit 3 (associated or not, in the different embodiments described, to a transport unit 40) even after the beginning of a task can be modified in real time, in particular updated/rescheduled, depending on any change that have occurred, or emergency situation, which leads to modify the priorities in the handling of samples or resources, in order to always ensure that every sample or resource undergoes the necessary operations in the shortest possible time, while constantly guaranteeing the best result both in the specific process in which the mobile unit 3 is involved and in the total one of the system 1.

A further clear advantage of the system according to the invention lies in the fact that the operational flexibility is ensured by guaranteeing at the same time a constant process traceability. The central computer control unit E is indeed constantly informed on the position of the transport units 40, on the position of the mobile units 3, and on the progress level of the operative procedure to which each sample or resource T is assigned, while maintaining a constant correlation with the data of the processing already performed and of the processing still to be performed.

The central computer control unit E manages all the steps of the process for all the samples and resources which are in the work area of the system 1, starting from their entry up to their exit from it and beyond, since the data originating from the operations/processing undergone by the samples/resources must be maintained to be usable if necessary even beyond the lifetime of the sample itself (e.g. for reasons of audit, analysis and continuous improvement of the processes, etc.).

The central computer control unit E also takes care, even in the view of a global management of the process, to manage the routing of the samples or resources transported by each transport unit 40 along the entire extension of the work area of the system 1, ensuring at any time for each of them full traceability and on board identification of the specific mobile unit 3 and recovering an appropriate association after the processing by a workstation or process island 2 has taken place on them and they are therefore returned aboard a mobile unit 3 in motion. On the other hand, the routing by the central computer control unit E is managed in such a way as to ensure, for example, the grouping of the samples or resources as homogeneously as possible within each mobile unit 3, considering first of all the nature and the possible needs of the samples or resources transported and secondly the type of operations which they must undergo by the modules aboard the mobile unit 3 or by the workstations or process islands 2. In this sense, it is well understood how the modularity/scalability of each mobile unit 3 is a great added value, since it allows to add/remove operating modules aboard it according to the changing needs of the work area.

The on board electronic control unit El (figure 3) positioned within each single mobile unit 3 and enslaved to the central computer control unit E, autonomously manages the workflow of the samples between the different operating modules of each mobile unit 3.

Therefore, the central computer control unit E constitutes the operative intelligence that is the basis of the management of the system operation and of the related process and therefore of the control and interaction between the aforementioned operating modules, transport units 40, mobile units 3 (and related operating modules) and workstations or process islands 2.

Furthermore, the central computer control unit E must necessarily interface also with what is located around the work area, i.e. with the various computer systems (for example, but not limited to, logistic, production, administrative systems, etc.) that are in close communication with the work area in which the process takes place, by virtue of a continuous exchange of information necessary to maintain the aforementioned "Chain of Custody" and the traceability of the samples, resources and metadata that arise from them, even upstream and downstream of the processes that take place in the work area of the system 1.

The scalability of the configuration of the mobile unit 3 clearly ensures that each type of operating module within the mobile unit 3 can, according to the needs, also be replicated within the mobile unit itself. Even the appropriate grouping of operating modules responds to the specific need to have, as far as possible, at the same time aboard each mobile unit 3 samples and/or resources on which similar if not identical operations must be performed in order to address, downstream of the aforementioned operations, the samples or resources at the same workstation or process island 2 or at stations/islands anyway close to each other.

To ensure that an undesired decoupling between a transport unit 40 and a mobile unit 3 cannot occur, four locking/unlocking means can be provided on the transport unit 40, which ensure the tightness of the connection between the transport unit 40 and the mobile unit 3. Naturally, these further locking/unlocking means can be automatically controlled each time a transport unit 40 has to be hooked or unhooked from a mobile unit 3.

As already indicated several times, the operations on the samples or resources aboard each mobile unit 3, by the operating modules that compose it, can also take place during the movement of the mobile unit 3. Of course, considering the reference system relative to the mobile unit 3, the individual sample or resource is stationary while it is being processed, while it is in the absolute reference system of the work area that the sample or resource moves, resulting in a clear saving in terms of time compared to known solutions, in which the samples or resources are moved along a fixed conveyor, and undergo a process phase only while they are stationary, both in a relative and an absolute sense, in a workstation.

In the system 1, following the unloading of samples or resources in a workstation or process island 2, the corresponding mobile unit 3 can stop, waiting to receive the same samples or resources again at the end of their processing, or it can immediately restart toward a subsequent workstation or process island 2. In this case it is expected that the samples or resources just unloaded are then taken over by a further mobile unit 3. Alternatively, the first mobile unit 3 can receive samples or resources outgoing from the same workstation or process island 2, which had been brought to the station or island 2 by a different mobile unit 3 and which meanwhile have completed their processing step.

The management of the operation of every single mobile unit 3 is relied on the on board electronic control unit El, subject to the control of the central computer control unit E. In general, the central computer control unit E supervises at any time the entire flow of samples or resources in the work area of system 1, always having under control the entire fleet of transport units 40, and the related mobile units 3 carried by them. The central computer control unit E is therefore able to detect the operating stress of each transport unit 40, which allows to select which transport unit 40 must be in charge of the performance of each specific task, possibly modifying the choice of which mobile unit 3 must, for example, go in correspondence of a specific workstation or process island 2. Such possibility is particularly important in the cases where a certain emergency occurs whereby it is necessary to proceed, in a sudden and completely unexpected manner, with an immediate processing of one or more samples or resources, which therefore immediately become priority.

In other words, the path followed by each mobile unit 3, which in a routine situation is normally predetermined through an addressing logic managed by the central computer control unit E and typically involves the movement through various workstations or process islands 2 in succession, can certainly be modified according to extemporaneous situations, for example emergency situations.

The exchange of information at the software level with the other computer systems, interfaced at any level to the system 1, is also continuous. In this way, the recall if necessary of the mobile unit 3 in the various points of the work area of the system 1 is managed also on the basis of the operating modules which are part of each mobile unit 3 and according to the logic of a distribution of the workload, among all the present mobile units 3, which is as homogeneous as possible. In particular, an attempt is made to optimize as much as possible the behavior of the system 1, making sure that the largest possible number of samples or resources T hosted by the same mobile unit 3 is subjected to common processing at the same workstations or process islands 2.

The system 1 must foresee the eventuality in which, to make room for any samples or urgent resources aboard a mobile unit 3, the samples or resources already on board can be parked, if in the way, at loading/unloading points arranged in the work area. In particular, several accumulation areas can be foreseen in different areas of the work area.

The mobile units 3, and possibly the operating modules aboard the same, are equipped with long-lasting batteries and with a recharging mechanism, which is able to be coupled to recharging stations arranged in certain predetermined points of the work area. In this way, each mobile unit 3 can periodically be positioned at a recharging station (for example at the end of the day) in order to be operative again in a short period of time.

Each transport unit 40 is equipped with sensors for detecting the proximity of objects and moving people within the range of the transport unit, which temporarily block the unit, avoiding any type of impact until the obstacle has moved. If necessary, if a movement of the obstacle is not detected within a predetermined time interval, the on board electronic control unit E2 can order the transport unit 40 to change its route, in any case on the basis of a task to be accomplished under the control and the supervision of the central computer control unit E.

The system 1 is able to manage workflows that never stop, thus covering the entire day and seven days a week. Naturally, a number of transport units 40 (and a number of operating modules forming each mobile unit 3) must be provided in proportion to the size of the laboratory as well as to the number and diversity of workstations or islands 2 which are in the work area. On the other hand, the system 1 can also manage (especially in low shift work areas that do not operate throughout the day, but stop during the night) situations in which the mobile units 3 are at rest and the transport units 40 can therefore be reused to transport material of a different type with respect to the main application of system 1. On the other hand, it is well understood how the nature of what is transported can widely vary.

The workstations or process islands 2 positioned in predetermined areas of the work area in turn constitute interfaces to instrumentation of various kinds. They can in turn comprise, in the preferred embodiment, pre-analysis, analysis or post analysis modules in which the samples or resources can be unloaded, and also be equipped with an automated line of any known type that connects the aforementioned modules. The samples or resources T are then again taken by a mobile unit 3 once the processing in the workstation or process island 2 is finished.

The construction details of each workstation or process island 2 are not illustrated here, both because they can be made in any known way, and because the configuration and operation of these stations is not of interest for the purposes of the present application.

In any case, each workstation or process island 2 is configured as a separate entity, in which only the samples or resources T that require processing by that specific station or island 2 are loaded/unloaded, according to the logic of an optimal addressing of samples or resources, managed by the central computer control unit E.

The most relevant advantage of the invention is therefore that of realizing a system for control, traceability and automation of a process in which mobile process units are arranged, free to be transported through the work area of the system 1 to allow, aboard the same, the processing of samples or resources during transport.

The adopted solution therefore allows, compared to conventional solutions, a considerable saving of time due to the parallelization of processing operations on samples or resources.

Another significant advantage is the free handling of samples or resources, thanks to the use of transport units, whose configuration is adapted to the environment of the work area wherein they must move. The flexibility of the system also arises from the possibility of configuring each mobile unit by combining a plurality of operating modules in a different way, in order to perform a series of specific operations.

In addition to the advantage of speeding up the processing of samples or resources thanks to the parallelization of the processing operations on them during transport, it is evident that with the use of the system according to the invention each sample or resource can only make the route it needs to move from a starting point to an arrival point, unlike the known solutions, in which the construction constraints of automatic conveyors often force a sample or resource, to reach an automation module intended to process it, to go through a long route in the automation system, not coinciding with what would be the optimal path and with consequent waste of time.

Another evident added value of the solution herein described consists in the modularity/scalability of the system, which allows if necessary to continuously modify and reconfigure the number and/or the composition of the transport units and mobile process units, according to the size and the operating volumes of the work area and also, for example, in case of emergency situations.

Furthermore, the fact of delegating the transport of samples or resources to mobile process units, possibly transported by mobile transport units, unburdens even more, compared to known solutions, the operators of the work area from having to devote themselves to the control of the effective execution of a correct routing of samples or resources, allowing those who manage the use of personnel in the system to free it for other activities and/or reduce it.

Furthermore, the system according to the invention involves a drastic reduction of components with respect to traditional systems equipped with automatic conveyors, is less prone to failures, malfunctions or components break and therefore is in general more reliable. There is therefore undoubtedly a significant saving in terms of costs of installation and maintenance of the work area.

The possible break of a transport unit can be balanced by recalling another similar transport unit, substantially without any loss of time, unlike what happens in known systems with automatic conveyors, in which a break of the conveyor can lead to an extended stop of the entire system.

The presence of a transport unit means that there are no construction constraints arising from the spaces available for the work area. Indeed, often in known solutions the installation of an automatic conveyor, especially if large- sized, is made difficult by the configuration and walls of the work area, and in general by the construction limits of the rooms that constitute it. The solution herein described, on the contrary, providing for the possibility for each transport unit to modify, in particular update/reschedule, its own route in the absence of a physical obstacle, makes it possible to cover anyway the predetermined path, from the starting point to the arrival point.

The system according to the invention moreover guarantees the full traceability of the transported material and the appropriate association of the data of the real process with those of the "Digital Twin", all regardless of the type of material or processing, being the solution adaptable to different applications, which can therefore possibly coexist in a single work area.

Preferably, the system according to the invention also allows a scheduling by time slots of the activities still to be carried out in the work area, for example to prefer a specific activity over another in different parts of the day.

In the event that the environment or the work/process area is identified with an hospital or similar structure, it is evident that such environment or area can advantageously be enlarged to include not only the pavilions or areas where the workstations or process islands are physically located, where the laboratory analysis processes and/or clinical or diagnostic testing are carried out, but also the rooms where the actual assistance/care of the patient (the so-called Point Of Care) takes place. In this case the aforementioned means for moving samples or resources in the work/process area, in particular the aforementioned mobile units, and possibly the aforementioned self-propelled transport units, allow to manage samples or resources from the sampling points to the workstations or process islands, with the consequent advantages of:

- ensuring the correct conservation and identification of such samples or resources;

- ensuring the so-called "Chain of Custody" of all the transported material (both biological and other kind of samples);

- being able to start performing one or more operations on transported samples or resources,

- reducing or totally eliminating the risk of contamination of the transported samples or resources, as well as

- reducing or totally eliminating the biological and chemical risk toward the operators who usually had to manually manage and carry out the transport of samples or resources from the sampling points to the analysis laboratories.

According to the invention, the process for control, traceability and automation of processes and automation of laboratory analysis processes and/or clinical or diagnostic testing using the aforementioned system 1 comprises the steps of:

- providing a work/process area;

- providing one or more workstations or process islands 2 having means for carrying out laboratory analysis and/or clinical or diagnostic testing on samples or resources T ;

- providing means for moving samples or resources T in said work/process area toward, from and between said one or more workstations or process islands 2 and/or loading/unloading points 6, 8 of said system 1 and

- providing a central computer control unit E for supervising the operation of said system 1, wherein:

- said one or more workstations or process islands 2 are in data communication with said central computer control unit E to receive and provide information about laboratory analysis processes or clinical or diagnostic testing to be carried out, and about the results of such analysis or testing;

- said means for moving samples or resources T in said work/process area toward, from and between said one or more workstations or process islands 2 comprise one or more mobile units 3 each designed to receive, carry and deliver samples or resources T from at least one input workstation to at least one output workstation of said system 1 and from and to one or more workstations or process islands 2;

- each mobile unit 3 is suitable to be selectively interfaced/coupled with said one or more workstations or process islands 2 to deliver and/or receive samples or resources T to be processed or already processed in said one or more workstations or process islands 2;

- each mobile unit 3 is equipped with an electronic control unit El in operative communication with said central computer control unit E;

- moving means 4 and a detection and guide system 406, E2 in operative communication with said central computer control unit E are associated to each mobile unit 3 and

- said central computer control unit E is programmed to supervise the operation of each mobile unit 3 and to control the free movement of each mobile unit 3 in said work/process area along a free path that can be flexibly modified by said central computer control unit E according to a predetermined cycle of operations and analyses in succession according to which to process specific samples or resources T located aboard each mobile unit 3 in said one or more workstations or process islands 2, said process comprising the steps of

- positioning the mobile units 3 at said input workstation of said system 1 to load samples or resources T;

- controlling by means of said central computer control unit E the movement of said mobile units 3 from and to one of said one or more workstations or process islands 2; - under the control of said central computer control unit E, unloading all or part of the samples or resources T into a predetermined workstation or process island 2 for processing them in said one or more workstations or process islands 2;

- under the control of said central computer control unit E, loading all or part of the samples or resources T processed by a predetermined workstation or process island 2 toward said one or more mobile units 3 and

- under the control of said central computer control unit E, unloading all or part of the samples or resources T into said output workstation of said system 1 at the end of the processing/work steps and

- updating/rescheduling by said central computer control unit E the operations or analyses still to be carried out for each individual sample or resource T on the basis and/or according to the results of the operations or analyses already carried out on said samples or resources T in said one or more workstations or process islands 2.

Preferably, the aforementioned steps of unloading all or part of the samples or resources T into a predetermined workstation or process island 2 or loading all or part of the samples or resources T from a predetermined workstation or process island 2 are preceded by a step of interfacing said mobile unit 3 with a respective workstation or process island 2.

Preferably, the aforementioned samples or resources T are moved one or more times between said mobile units 3 which movement takes place along a free and flexibly modifiable/reschedulable path established by said central computer control unit E until completion of all laboratory analysis processes and/or clinical or diagnostic testing expected for each specific sample or resource T according to a work plan stored in said central computer control unit E for each specific sample or resource T, said work plan being updated/rescheduled by said central computer control unit E determining for each specific sample or resource T the operations or analyses still to be carried out on the basis and/or according the results of said operations or analyses already performed on said samples or resources T in said one or more workstations or process islands 2.

Preferably:

- said samples or resources T undergo operations and/or processes of pre analysis, analysis and/or post-analysis in one or more operating modules Ml, M2, M3, M4, M5, M6 during transport and/or stay aboard said one or more mobile units 3 and

- said central computer control unit E, on the basis and/or according to the results of said one or more operations and/or processes already carried out on said samples or resources T in said one or more operating modules Ml, M2, M3, M4, M5, M6 during transport and/or stay aboard said one or more mobile units 3:

• updates/reschedules said operations or analyses still to be carried out on each individual sample or resource T and/or

• updates/reschedules the path and the destination of said mobile units 3 within said work/process area between said one or more workstations or process islands 2.

Obviously, a person skilled in the art, in order to satisfy temporary and specific needs, will be able to make many modifications and changes to the system and process described above, all of which anyway included within the scope of protection of the invention as defined by the following claims.

Claims

1. A system for control, traceability and automation of laboratory analysis processes and/or clinical or diagnostic testing, said system (1) comprising, in a work/process area:

- one or more workstations or process islands (2) having means for carrying out laboratory analysis and/or clinical or diagnostic testing on samples (T);

- means for moving samples or resources (T) in said work/process area toward, from and between said one or more workstations or process islands (2) and/or loading/unloading points (6, 8) of said system (1) and

- a central computer control unit (E) for supervising the operation of said system (1), wherein said one or more workstations or process islands (2) are in data communication with said central computer control unit (E) to receive and provide information about where to carry the samples or resources (T) to be processed or already processed, characterized in that:

- said means for moving samples or resources (T) in said work/process area toward, from and between said one or more workstations or process islands (2) comprise one or more mobile units (3) each being suitable to receive, carry and deliver samples or resources (T) from at least one input workstation to at least one output workstation of said system and from and to one or more workstations or process islands (2);

- each mobile unit (3) is suitable to be selectively interfaced/coupled with said one or more workstations or process islands (2) to deliver and/or receive samples or resources (T) to be processed or already processed in said one or more workstations or process islands (2);

- each mobile unit (3) is equipped with an electronic control unit (El) in operative communication with said central computer control unit (E);

- to each mobile unit (3) moving means (4) are associated;

- to each mobile unit (3) a detection and guide system (406, E2) in operative communication with said central computer control unit (E) is associated;

- said central computer control unit (E) is programmed to supervise the operation of each mobile unit (3) and to control the free movement of each mobile unit (3) in said work/process area along a free path that can be flexibly modified/rescheduled by said central computer control unit (E) according to a predetermined cycle of operations and analyses in succession according to which to process specific samples or resources (T) in said one or more workstations or process islands (2), wherein the operations or analyses still to be carried out for each sample or resource (T) are updated/rescheduled by said central computer control unit (E) on the basis and/or according to the results of the operations or analyses already carried out on said samples or resources (T) in said one or more workstations or process islands (2).

2. A system as claimed in claim 1, wherein:

- said one or more mobile units (3) are also process units for processing samples or resources (T) and comprise one or more operating modules (Ml, M2, M3, M4, M5, M6) to perform, under the control of said central computer control unit (E), on samples or resources (T) located aboard said one or more mobile units (3), operations and/or processes of pre-analysis, analysis and/or post-analysis, before said samples or resources (T) are delivered to a workstation or process island (2) to undergo operations or analyses, or after said samples or resources (T) have been returned to the mobile unit (3) and

- said central computer control unit (E), on the basis and/or according to the results of the one or more operations and/or processes already carried out on said samples or resources (T) in said one or more operating modules (Ml, M2, M3, M4, M5, M6) during transport and/or stay aboard said one or more mobile units (3):

• updates/reschedules said operations or analyses still to be carried out on each individual sample or resource (T) and/or

• updates/reschedules the path and the destination of said mobile units (3) within said work/process area between said one or more workstations or process islands (2).

3. A system as claimed in claim 2, wherein each mobile unit (3) comprises an output (U) for the samples or resources (T) that are to be delivered to a workstation or process island (2), an input (I) for receiving samples or resources (T) returning from a workstation or process island (2) and one or more of the following modules:

- an input module (Ml) for receiving the samples or resources (T) to be fed toward successive modules of the mobile unit (3);

- a module (M2) for reading, preferably for optically reading, an identification code with which said samples or resources (T) are uniquely identified, said module (M2) for reading being in operative communication, via said electronic control unit (El), with said central computer control unit (E), to transmit the code detected on each sample or resource (T),

- a module (M3) for manipulating said samples or resources;

- a module (M6) for removing and/or applying a sealing cap to the container in which each sample or resource (T) is contained;

- a refrigeration module; - a heating module;

- a module for centrifuging the sample or resource (T);

- a singularization module;

- a transport module (M4), for transporting samples or resources (T) from said input module (Ml), through the successive operating modules to said output (U), for delivery of the samples or resources (T) to a workstation or process island (2), and

- a transport module (M5) for transporting samples or resources (T) that return into the mobile unit (3) through said input (I), said transport module (M5) being suitable to return said samples or resources (T) again to said output (U) for delivery to a successive workstation or process island (2) or to a loading/unloading point (6, 8).

4. A system as claimed in any of claims 1 to 3, wherein said moving means and said detection and guide system in operative communication with said central computer control unit are entirely integrated aboard said mobile unit.

5. A system as claimed in any of claims 1 to 3, wherein said moving means (4) associated with each mobile unit (3) comprise:

- first moving means (11, 12, 13, 21, Ml, M3, M4, M5, M6) integrated aboard each mobile unit (3) for moving and manipulating said samples or resources (T) in said mobile unit (3) and/or for delivering/receiving samples or resources (T) to be processed or already processed in said one or more workstations or process islands (2) and

- second moving means comprising self-propelled transport units (40) which can be selectively and releasably coupled to a respective mobile unit (3) to move said respective mobile unit (3) within said work/process area, wherein said detection and guide system (406, E2) in operative communication with said central computer control unit (E) is mounted aboard each of said self- propelled transport units (40).

6. A system as claimed in claim 5, wherein each self-propelled transport unit (40) is in the form of an autonomous mobile robot having a coupling mechanism (400), to ensure coupling with a containing structure (300) that contains said mobile unit (3) and make said mobile unit (3) transportable.

7. A system as claimed in any of claims 1 to 6, comprising an interface unit (9) for each of said one or more workstations or process islands (2), said interface unit (9) being configured to operatively and selectively couple the workstation or process island (2) with a respective mobile unit (3) to enable automated transfer of samples or resources (T) from the mobile unit (3) to the workstation or process island (2), and vice versa.

8. A system as claimed in claim 7, wherein each interface unit (9) comprises an outwardly facing first interface portion (9A) for interfacing, preferably in a standard manner, with said respective mobile unit (3) and a second opposite adapter portion (9B) configured according to the specific features of the respective workstation or process island (2) with which it is associated.

9. A system as claimed in any of claims 1 to 8, wherein each mobile unit (3) is associated with at least one sensor/detector device (333) connected to its respective electronic control unit (El), to report information about the position of the particular mobile unit (3) to said central computer control unit (E), said central computer control unit (E) being programmed to retrieve an information about the position of each mobile unit (3) on the basis of an information about the initial position of the mobile unit (3) and of a storage of all the movements of said mobile unit (3), whether or not coupled to a self-propelled transport unit (40).

10. A system as claimed in any of claims 1 to 9, wherein each mobile unit (3) is equipped with at least one rechargeable electric battery (Bl) for supplying power to electrical components carried aboard said mobile unit (3).

11. A process for control, traceability and automation of processes and automation of laboratory analysis processes and/or clinical or diagnostic testing using a system (1) as claimed in one or more of claims 1 to 10, comprising the steps of:

- providing a work/process area;

- providing one or more workstations or process islands (2) having means for carrying out laboratory analysis and/or clinical or diagnostic testing on samples or resources (T);

- providing means for moving samples or resources (T) in said work/process area toward, from and between said one or more workstations or process islands (2) and/or loading/unloading points (6, 8) of said system (1) and

- providing a central computer control unit (E) for supervising the operation of said system (1), wherein:

- said one or more workstations or process islands (2) are in data communication with said central computer control unit (E) to receive and provide information about laboratory analysis processes or clinical or diagnostic testing to be carried out, and about the results of such analysis or testing;

- said means for moving samples or resources (T) in said work/process area toward, from and between said one or more workstations or process islands (2) comprise one or more mobile units (3) each designed to receive, carry and deliver samples or resources (T) from at least one input workstation to at least one output workstation of said system (1) and from and to one or more workstations or process islands (2);

- moving means (4) and a detection and guide system (406, E2) in operative communication with said central computer control unit (E) are associated to each mobile unit (3) and

- said central computer control unit (E) is programmed to supervise the operation of each mobile unit (3) and to control the free movement of each mobile unit (3) in said work/process area along a free path that can be flexibly modified by said central computer control unit (E) according to a predetermined cycle of operations and analyses in succession according to which to process specific samples or resources (T) located aboard each mobile unit (3) in said one or more workstations or process islands (2), said process comprising the steps of:

- positioning the mobile units (3) at said input workstation of said system (1) to load samples or resources (T);

- controlling by means of said central computer control unit (E) the movement of said mobile units (3) from and to one of said one or more workstations or process islands (2); - under the control of said central computer control unit (E), unloading all or part of the samples or resources (T) into a predetermined workstation or process island (2) for processing them in said one or more workstations or process islands (2);

- under the control of said central computer control unit (E), loading all or part of the samples or resources (T) processed by a predetermined workstation or process island (2) toward said one or more mobile units (3) and

- under the control of said central computer control unit (E), unloading all or part of the samples or resources (T) into said output workstation of said system (1) at the end of the processing/work steps and

- updating/rescheduling by said central computer control unit (E) the operations or analyses still to be carried out for each individual sample or resource (T) on the basis and/or according to the results of the operations or analyses already carried out on said samples or resources (T) in said one or more workstations or process islands (2).

12. A process as claimed in claim 11, whereby said steps of unloading all or part of the samples or resources (T) into a predetermined workstation or process island (2) or loading all or part of the samples or resources (T) from a predetermined workstation or process island (2) are preceded by a step of interfacing said mobile unit (3) with a respective workstation or process island (2).

13. A process as claimed in claim 11 or 12, wherein said samples or resources (T) are moved one or more times between said mobile units (3) which movement takes place along a free and flexibly modifiable/re schedulable path established by said central computer control unit (E) until completion of all laboratory analysis processes and/or clinical or diagnostic testing expected for each specific sample or resource (T) according to a work plan stored in said central computer control unit (E) for each specific sample or resource (T), said work plan being updated/rescheduled by said central computer control unit (E) determining for each specific sample or resource (T) the operations or analyses still to be carried out on the basis and/or according the results of said operations or analyses already performed on said samples or resources (T) in said one or more workstations or process islands (2).

14. A process as claimed in any of claims 11 to 13, wherein:

- said samples or resources (T) undergo operations and/or processes of pre- analysis, analysis and/or post-analysis in one or more operating modules (Ml, M2,

M3, M4, M5, M6) during transport and/or stay aboard said one or more mobile units (3) and

- said central computer control unit (E), on the basis and/or according to the results of said one or more operations and/or processes already carried out on said samples or resources (T) in said one or more operating modules (Ml, M2, M3, M4, M5, M6) during transport and/or stay aboard said one or more mobile units (3):