GB2587180A

GB2587180A - Smart system for pre-analytic sample management

Info

Publication number: GB2587180A
Application number: GB1904543.4A
Authority: GB
Inventors: Maria Heyn Hans; Thimotheus Bõge Yannick; Flötto Julia; Dancker Malte
Original assignee: Dx Labtrack GmbH
Current assignee: Dx Labtrack GmbH
Priority date: 2019-04-01
Filing date: 2019-04-01
Publication date: 2021-03-24
Also published as: GB201904543D0

Abstract

A pre-analytical sample management system configured to process a sample and manage one or more sample containers, the system comprising an interactive display for input and/or output operations 1, a sample container loader 2, a sample container registration unit 3, a sample mixer unit 5, a centrifugation unit 6, a sampling sorting unit 7, a sample storage unit 8 and a data processing unit 4. The system is a used for sample management, tracking and processing in a medical environment such as a hospital or doctor’s surgery. The display unit may be used to input data, verify patient or practitioner ID or give operator guidance. The container loader is a mechanical container displacement device such as a robotic component. The registration unit may be an optical detection unit, such as a camera or spectroscope, for identifying a sample container. The sorting unit automatically sorts and separates sample containers based upon factors such as container ID, cap colour, shape, storage requirements, and intermediate and final destinations. The storage unit retains the containers and may be a temperature-controlled environment. The containers may be transported for subsequent analysis, with the system connected to a pneumatic tube transport system. Optionally, the system comprises a container labelling unit and/or an analytical unit.

Description

Smart system for pre-analytic sample management

FIELD OF THE INVENTION

[0001] The present invention relates to a stationary sample container rack designed to receive one or more sample container(s) as a base station, wherein said stationary sample container rack is configured to process the sample and/or manage the sample con- tainer(s). The invention further refers to a system comprising a stationary sample con-tainer rack and one or more of the following: (i) one or more mobile sample container racks; (ii) a pneumatic tube system; (iii) a remote receiving station; and (iv) a sample analyzer. Also envisaged is a method for pre-analytically determining one or more parameter(s) of a sample provided in a sample container and/or of a sample container, wherein said determination is performed in the stationary sample container rack ac-cording to the invention.

BACKGROUND OF THE INVENTION

[0002] Today, almost 70% of all medical decisions are based on laboratory data. The importance of laboratory data it is raising in the age of data-based precision medicine and patients will benefit in the future from tailor-made and individualized treatment strategies based on their individual diagnosis.

[0003] Digitization and smart technologies enable pharmaceutical and biotech companies to perform quantum leaps in research and drug development. Due to more precise analysis and innovations in the field of precision medicine, more sensitive tests and specific differential diagnoses become possible. Blood-based biomarker tests are gaining in importance. As a result, significantly more blood samples will be collected, sent and analysed using high-resolution diagnostic assays, e.g. liquid biopsy for genetic profiling or disease monitoring of cancer patients by analysing a very low amount of circulating tu-mor cells or circulating tumor DNA is raising.

[0004] Nevertheless, the diagnostic process is a highly fragmented multi-step process involving several parties. The process starts at the physician with the test prescription best fitting the patients symptoms, followed by patient preparation for testing, blood io sample collection, sample handling, storage and preparation, transportation (these steps are defined as pre-analytical phase), sample analysis (this step is defined as analytical phase), test validation, interpretation and reporting and typically ending with clinical decisions driven by the test results (these steps are defined as post-analytical phase) (see Lippi et al., 2019, Clin Chem Lab Med, 1-8).

[0005] Alarmingly, 70% of all mistakes made in medical diagnostics occur in the pre-analytical phase, most of which arise from problems in patient preparation, sample collection and transportation at site of sample collection (West et al., Annals of Clinical Biochemistry, 2017). In particular, pre-analytical multiple steps are highly error-prone. Already before sample collection, ordering the right laboratory test at the right time for the right patient has become quite easy, especially when electronic order-entry systems are being used. However, this approach often leads to the phenomenon of overutilization of laboratory tests, or results in the selection of inappropriate tests due to unknown or not consistent test abbreviations. In addition, preparation of sample collection tubes, including the selection of the correct primary sample collection tube and labelling it with the correct and patient -specific barcode or label, is highly error-prone. Sample tubes, barcodes and the identity of the patient must be verified during or directly after sample collection. Especially if collection tubes are prepared with barcodes at an earlier time-point, wrong sample tubes may potentially be used, or they may be linked to the wrong patient (von Meyer et al., 2019, Diagnosis, 6(1), 1-3). Inappropriate sample quality, such as haemolysed, clotted, or contaminated samples, which is due to incorrect sampling technique or inappropriate sample quantity, i.e., insufficient volume or incorrect blood to anticoagulant ratio, were shown to occur frequently (Li ppi et al., Diagnosis, 2019). In s order to avoid these problems, sample tubes must be treated in specific ways according to manufacturer's protocol upon sampling. The procedure includes mixing blood with additives, followed by a specific incubation time at a specific temperature, e.g. 30 minutes at room temperature. Subsequently, it may be necessary to centrifuge the samples, e.g. at 1000 g for 10 minutes at 18 -25 °C. Finally, the samples must be stored io under specific temperature conditions until processing in the analytical phase or transport to an analytic site (Sarstedt AG & Co KG, Niimbrecht, Tips & Techniques in Preanalytics, 2018).

[0006] In a hospital setting the transport is typically performed in-house via a pneumatic tube system or by personal delivery. For settled practitioners and outpatients' settings is samples are normally picked up once a day by courier service and often travel a few hundred kilometers to their destination to be analyzed by laboratory service providers. Upon arrival in the laboratory, samples are registered and processed. Between 6 -10 % of all samples are currently processed manually at this stage. This activity and connected trouble shooting efforts already comprise about 25 % of the lab operational staff costs.

Most of these samples typically need manual handling because they are negatively af-fected by pre-analytical errors such as wrong tube allocation, wrong label placements, mislabeling, low filling volumes, hemolysis, non-conforming mapping of lab orders or sample barcodes, missing or redundant samples or lab orders etc. These complications strongly compromise the samples' quality already before their arrival in the laboratories and lead to additional manual labour at sample entry to assure quality. The total costs for processing a sample manually due to any of these errors is assumed to be at least twice the cost of an automated processing. Furthermore, an additional 5 % of all goods and consumables must be spent to achieve reimbursable results due to repetitive measurements.

[0007] Detecting and reducing these pre-analytical errors automatically at the point of blood collection is believed to significantly improve medical quality and cut short the spending of an average laboratory by at least 10 %. By improving medical quality and reducing costs for inappropriate patient treatment via automation and streamlining up to 400 million Euros can be saved annually in the German healthcare system and up to 2.000 million Euros all over Europe. Thus, automation and efficiency are key for further profits and key driver of innovation in this highly competitive market. Increased diagnostic quality, improved patient safety, easier compliance with regulatory guidelines (e.g. ISO 15189:2012) and competitive advantages constitute additional values. In par-ticular, regulatory compliance is essential for medical laboratories with respect to their accreditation. According to the International Standard for medical laboratories accreditation (ISO 15189: 2012) "the laboratory shall establish quality indicators (01) to monitor and evaluate performance throughout critical aspects of pre-examination, examination and post-examination processes" and "the process of monitoring Qls shall be planned, which includes establishing the objectives, methodology, interpretation, limits, action plan and duration of measurement". Therefore, the establishment of Qls covering the entire diagnostic process should be considered "a must" for complying with the requirements of the International Standard and achieving accreditation. Recommended Qis are for example misidentified sample misidentified patients, unlabeled samples, wrong sample tube type, inappropriate sample type, incorrect fill level, samples clotted or he- matology/coagulation status (Plebani et al., 2015, Clin Chem Lab Med, 53(6), 943-948).During the last decades blood-based tests were improved by developing technically advanced laboratory analyzers by focusing on the analytical procedures in the lab, leading to a technical error rate below 0.1 % today. Internal quality controls (QCs) are man-datory for technical validation of laboratory analyzers to ensure analytical quality and to prevent the release of erroneous results and ultimately avert patient harm. QC of biochemical tests typically relies on the measurement of well-characterized control samples. Comparison of measured and assigned values can reveal systematic and random analytical errors of the test (Bietenbeck et al., 2017, Clinical Chemistry, 63(8), 13771387).

[0008] However, quality strategies typically focus on the technical validation of laboratory analyzers in the analytical phase whereas the "biological validation" of human sam-pies, especially during the error-prone multi-step pre-analytical phase, has not yet been considered.

[0009] There is hence a need for creative and effective solutions for a seamless and traceable quality assurance approach for human samples, which specifically allows to monitor error-prone pre-analytical steps and to assess evidence-based quality indica-tors.

OBJECTS AND SUMMARY OF THE INVENTION

[0010] The present invention addresses this need and provides in one aspect a stationary sample container rack designed to receive one or more sample container(s) as a base station, wherein said stationary sample container rack is configured to process the sa m-ple and/or manage the sample container(s), wherein said stationary sample container rack comprises at least three or more of the following: an interactive display for input and/or output operations, a sample container loader, a sample container registration unit, a sample mixer unit, a centrifugation unit, a sample sorting unit and a sample storage unit, wherein said stationary sample container rack is connectable to one or more mobile sample container rack(s) for transport. The stationary sample container rack ad- vantageously provides a solution with respect to the lack of automated data collection in the LIS. The described pre-analytic approach accordinglyallows to overcome the problems in sample collection, namely that no automated timestamps of sample collection are provided, that sample misidentification occur or that low filing volumes are pro- vided. Also, problems in sample handling are tackled, namely that no standardized pro-cess is used, that mixing and centrifugation procedure are often unclear and that samples get lost. Furthermore, problems in sample entry can advantageously be solved, e.g. the burdensome manual trouble-shooting can be avoided, sample entry delays can be reduced or completely abolished and the quality of sample data can significantly be increased since automated data on pre-analytic sample quality can be transferred to the testing site. The present invention thus provides the means and methods for a digital, s automated and seamless sample quality control and surveillance from sample collection to lab analysis. The presently claimed and herein described technology accordingly raises the safety, quality, auditability and traceability of samples such as blood samples to an unprecedented level. The use of a stationary sample container rack in combination with mobile sample container racks and smartly integrated sample containers according io to the invention and the associated control of all-important data in real time drastically reduces the risk of incorrect clinical data due to improper handling, mislabeling or other pre-analytical errors and improves compliance with regulatory requirements, e.g. pursuant to ISO 15189:2012.

[0011] In a preferred embodiment the sample container registration unit is an optical is detection unit. It is particularly preferred that the sample container registration unit is a camera or a spectroscope.

[0012] In a further preferred embodiment said stationary and said mobile sample container rack are capable of direct communication with each other; or of contactless communication with each other and/or with a remote receiving station. It is particularly pre- ferred that the contactless communication is based on one or more unit(s) for contact-less communication, configured for data transmission such as an RFID (radio frequency identification) unit, an NFC (near field communication) unit, a GSM, LTE or G5 unit, a LPWAN unit, a LoRaWAN unit, a Bluetooth unit or a WiFi unit.

[0013] In yet another preferred embodiment, the interactive display for input and/or output operations comprises an optical and/or acoustic intercommunication module and is configured to provide an interface and/or a functionality for one or more of the following tasks: verification of patient identity, preferably via measuring or receiving biometric data directly from the patient, or via a data carrier such as a smart cart, a mobile device or a wearable; acoustic operator guidance and/or receiving of acoustic commands; verification of operator identity, preferably via measuring or receiving biometric data directly from the patient, or via a data carrier such as a smart cart, a mobile device or a wearable; inputting of analytic orders or assignments; fetching of electronic health records; outputting of performed steps within the stationary sample container rack; outputting of steps to be performed outside the stationary sample container rack; and confirmation of performed steps within the stationary sample container rack and/or feedback on said steps or lack of said steps.

[0014] In a further preferred embodiment, the stationary sample container rack as men-is tioned above additionally comprises one or more of the following: a sample container reservoir, a label printer unit, a sample container labelling unit, an incubation unit and a storage unit.

[0015] In yet another preferred embodiment, said stationary sample container rack is connectable to a pneumatic tube system. It is particularly preferred that the stationary sample container rack comprises an adaptor for a pneumatic tube system. It is further preferred that said adaptor and said pneumatic tube system are configured for automatic loading and/or sending.

[0016] In an additional embodiment the stationary sample container rack as mentioned above additionally comprises one or more of the following: (1) a sensor device for monitoring, preferably for determining the temperature of the sample container and/or of the stationary sample container rack and/ or the environmental temperature and/or of the mobile sample container rack, preferably per individual sample container slot within the stationary sample container rack, a device for determining the humidity of the stationary sample container rack and/or of the mobile sample container rack, a light sensor and/or device capable of detecting the opening or closing of the stationary sample container rack and/or of the mobile sample container rack; (ii) a machine learning and data processing unit; (iii) a point of care testing unit; (iv) an acoustic input and/or output module; (v) a mechanic sample container displacement and manipulation unit, designed to move or reposition a sample container within the rack, or a connected com-ponent, preferably a mobile sample container rack and/or a pneumatic tube system, and/or to modify or change the shape and/or comprised volume of a sample container, preferably to press out residual air from a sample container; (vi) a unit for linkage to a patient file or patient order, configured for data trans-mission; (vii) a unit for linkage to a patient wearable, configured for data transmission; (viii) a unit for linkage to a health information system, LIS/KIS/CPOE or KAS system, configured for data transmission; (ix) a unit for linkage to an analyzer, configured for data transmission; (x) a unit for patient biometrics recognition, preferably of a patient's fingerprints or iris; (xi) a card reader; (xii) a sample container transportation unit; (xiii) a balance, configured to determine individual sample container weights; (xiv) a cooling and/or heating unit; (xv) a sample separation unit, preferably configured to separate liquid and solid components in a sample container in a centrifugation-free manner, more preferably configured to separate liquid and solid components in a sample container by sedimentation or ultrasonication.

[0017] In a particularly preferred embodiment said machine learning and data processing unit is configured to perform one or more of the following tasks: automatized evaluation of sample registration data and/or measured parameters, preferably of image data; autonomous calculation of key performance indicators (KPIs) or quality indicators obtained during one or more pre-a nalytic activities within or outside the stationary sample container rack; autonomous generation of system or user feedback on the basis of calculated KPIs; autonomous identification and marking or erroneous or defect samples and/or io sample containers; and comparison of measured data or parameters with a data or parameters derived from a database, preferably an internal database.

[0018] In a further embodiment the stationary sample container rack as mentioned above additionally comprises one or more of the following: (i) a de-recapper unit; (ii) an is aliquoting unit; (iii) a de-sealer unit; (iv) a physical link to an analyzer platform; and (vi) a smartphone, internet, intranet or app interface.

[0019] In a further aspect the present invention relates to a system comprising a stationary sample container rack as defined above and one or more of the following: (i) one or more mobile sample container racks; (ii) a pneumatic tube system; (iii) a remote re-ceiving station; and (iv) a sample analyzer.

[0020] In an embodiment of the stationary sample container rack or the system of the present invention said pneumatic tube system comprises a carrier component for transport of one or more sample containers, wherein said carrier component comprises one or more sensors designed to register temperature and/or acceleration data and/or time conditions of the sample container.

[0021] In a further embodiment of the stationary sample container rack or the system of the present invention, the mobile sample container rack(s) comprise two or more sections configured to receive sample containers of different shape, different content, different destinations, or different pre-analytic status.

[0022] In yet another embodiment of the stationary sample container rack or the system of the present invention the mobile sample container rack comprises one or more s of the following: one or more unit(s) for contactless communication with a base station, an RFID (radio frequency identification) unit, preferably an NFC (near field communication) unit, or a Bluetooth unit or an ID-chip unit, a barcode, a barcode reader, an RFID reader, a Bluetooth device, a digital memory, a data processing unit, a device for determining the temperature of the sample container and/or of the sample container rack, io preferably per individual sample container slot within the sample container rack, a de-vice for determining the humidity of the sample container rack, optionally a device capable of determining vibrations and centrifugal forces exerted on the rack, a geographic tracking device, preferably a GPS device and/ or a GSM triangulation unit, a device capable of determining time parameters of the sample container rack's use, a light sensor is and/or device capable of detecting the opening or closing of the sample container rack, an acoustic and/or optical alarm module, an electric power source, preferably a battery, and a communication module allowing for wireless and/or real-time communication with a remote receiving station.

[0023] In yet another aspect the present invention relates to a method for pre-analyti-cally determining one or more parameter(s) of a sample provided in a sample container and/or of a sample container, wherein said determination is performed in the stationary sample container rack as defined herein.

[0024] In a preferred embodiment of the method as mentioned above, said parameters comprise one or more selected from: identity of the sample and/or sample container; type of sample container, preferably identifiable via a color code and/or shape; loading status of the sample container(s); volume of the sample container(s), preferably identifiable by shape; filling volume of the sample container(s); sample number; specific position of the sample container(s) in the stationary sample container rack; temperature of the sample(s) and/or sample container(s) and/or stationary sample container rack, preferably at the time point of sample container placement in the stationary sample container rack; sample temperature at one or more time-points after sample container placement; humidity of the sample(s) and/or sample container(s); time parameters of the stationary sample container rack's use; time parameters of individual samples after sample container placement: index of the sample(s) relating to hemolysis, icterus or lipaemia; centrifugation status of the sample(s); presence of a liquid and/or solid phase and/ or of a separating gel layer in the sample(s); ratio of liquid and solid phases in the sample(s); sorting status of the sample container(s); storage status of the sample container(s); presence/absence of caps on the sample container(s); aliquoting status of the sample(s); and one or more quality parameter(s) of the sample(s), preferably pH, ionic concentration, and presence of apoptotic, inflammatory or infectious indicators.

[0025] In a preferred embodiment of the method of the invention said pre-analytical determining is initiated in an automatic manner via contactless communication between the sample container and the sample container rack by RFID (radio frequency identification), Bluetooth interaction, a GSM, LTE or G5 unit, a LPWAN unit, a LoRaWAN unit, or a WiFi unit, barcode reading or image capture, or wherein said checking is started after a stimulus is triggered (i) by a sample container passing a mechanic or optical barrier, or (ii) by an operator, preferably via manual activation of a start button.

[0026] In yet another preferred embodiment, said pre-analytical determining is performed in at least one sample container slot within the stationary sample container rack, and/or the mobile sample container rack, which is configured to check one or more pa-rameter(s) of a sample container.

[0027] Also envisaged, in another embodiment of the method of the present invention, the parameter value is provided in a digitalized form.

BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 provides an overview of some components of an embodiment of the stationary sample container rack according to the present invention.

[0029] Figures 2 shows further components which may be used in an embodiment of the stationary sample container rack according to the present invention.

[0030] Figure 3 shows steps of the human blood sample process.

[0031] Figure 4 depicts problems and errors during sample collection. [0032] Figure 5 depicts problems and errors during sample handling. [0033] Figure 6 depicts problems and errors during sample transport. [0034] Figure 7 depicts problems and errors during sample entry.

[0035] Figure 8 provides an overview a bout the perception of pre-analytical errors in European and international laboratory chain market.

[0036] Figure 9 shows components of a system embodiment of the present invention.

[0037] Figure 10 shows an example of one prototype of a stationary sample container rack according to the present invention.

[0038] Figure 11 provides an overview of the steps from point of collection to point of testing.

s DETAILED DESCRIPTION OF THE EMBODIMENTS

[0039] Although the present invention will be described with respect to particular embodiments, this description is not to be construed in a limiting sense.

[0040] Before describing in detail exemplary embodiments of the present invention, definitions important for understanding the present invention are given.

[0041] As used in this specification and in the appended claims, the singular forms of "a" and "an" also include the respective plurals unless the context clearly dictates otherwise.

[0042] In the context of the present invention, the terms "about" and "approximately" denote an interval of accuracy that a person skilled in the art will understand to still ensure the technical effect of the feature in question. The term typically indicates a de-viation from the indicated numerical value of ±20 %, preferably ±15 %, more preferably ±10 %, and even more preferably ±5 %.

[0043] It is to be understood that the term "comprising" is not limiting. For the purposes of the present invention the term "consisting of or "essentially consisting of is consid-ered to be a preferred embodiment of the term "comprising of". If hereinafter a group is defined to comprise at least a certain number of embodiments, this is meant to also encompass a group which preferably consists of these embodiments only.

[0044] Furthermore, the terms "(i)", "(ii)", "(iii)" or "(a)", "(b)", "(c)", "(d)'', or "first", "second", "third" etc. and the like in the description or in the claims, are used for distin-guishing between similar elements and not necessarily for describing a sequential or chronological order. It is to be understood that the terms so used are interchangeable under appropriate circumstances and that the embodiments of the invention described herein are capable of operation in other sequences than described or illustrated herein. In case the terms relate to steps of a method or use, there is no time or time interval coherence between the steps, i.e. the steps may be carried out simultaneously or there may be time intervals of seconds, minutes, hours, days, weeks, etc. between such steps, unless otherwise indicated.

[0045] It is to be understood that this invention is not limited to the particular methodology, apparatus, components, units, protocols, reagents, etc. described herein as these lo may vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to limit the scope of the present invention that will be limited only by the appended claims. Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of ordinary skill in the art.

[0046] As has been set out above, the present invention concerns in one aspect a sta-tionary sample container rack designed to receive one or more sample container(s) as a base station, wherein said stationary sample container rack is configured to process the sample and/or manage the sample container(s), wherein said stationary sample container rack comprises at least three or more of the following: an interactive display for input and/or output operations, a sample container loader, a sample container registra-tion unit, a sample mixer unit, a centrifugation unit, a sample sorting unit and a sample storage unit, wherein said stationary sample container rack is connectable to one or more mobile sample container rack(s) for transport.

[0047] As used herein a ''stationary sample container rack" is an apparatus which is spe- cifically designed to receive one or more sample container(s) as a base station. The sta-tionary sample container rack may, for example, be designed in different sizes and forms to accommodate different numbers and forms of sample containers. It may, for instance, have space for 1, 2, 4, 5, 10, 12, 20, 24, 30, 48, 50, 96, 100, 150, 200, 300, 384, 500, 1000, 2000 etc., or more sample containers, or any other suitable number of sample containers. It is preferred that the stationary sample container rack provides space for about 30 to 40 sample containers. The stationary sample container rack may be designed to accommodate only one size of sample containers, or it may provide space for differently sized sample containers. Sample container may be present in different com- partments or sections of the stationary sample container rack, e.g. according to their nature, their processing or pre-analytic status, their envisaged storage time and status, their quality status, their final or intermediate destination, their form or shape, their cap color etc. The stationary sample container rack is specifically designed as stationary ap-paratus, which is not itself used for the transport of sample containers. It is designed as receiving and pre-analytic station for samples in the context of sample collection, i.e. at a sample collection site such as a hospital, a laboratory, a private practice or the like. Accordingly, the stationary sample container rack may be provided with electricity connections, data connections and the like. It may also comprise any suitable adaptor or connector to further devices or apparatuses in the context of the sample collection site where it is used, e.g. printing facilities, intranet connectivity, database connectivity, sample transport functionalities etc. [0048] The sample containers may be accommodated in the stationary sample container rack in an anti-slip manner. It is preferred that the sample containers are accomo- dated such that they can easily be moved or repositioned, e.g. with the help of a me-chanic sample container displacement and manipulation unit as described herein.

[0049] The stationary sample container rack accordingly may comprise at least one, preferably more than one of the following: (i) An interactive display for input and/or output operations. The interactive display for input and/or output operations preferably comprises an optical and/or acoustic inter-communication module. The display is, in a typical embodiment, designed as communication entity which guides an operator or user or a nurse or medical practitioner or lab technician etc. through a list of activities connected with the pre-analytic sample processing. The display, being equipped with all necessary electronics and microcontroller elements for an acoustic and optical interaction, may provide sound or speech guidance to the operator in the form of commands, comments or questions and may also have a microphone unit able to record speech information from the operator. It may in addition or alternatively provide optical guidance to the operator in the form of icons, text or graphical elements showing the next steps to be performed, the status of the procedure etc. The display may have any suitable form or format. It may be configured as integral part of the rack. Alternatively, it may be connected to the rack, but removable there-from, e.g. via a plug connection. In further embodiments, the display may have the form of a tablet PC which is physically independent from the rack. Accordingly, the display may be used as a remote device, which can, for example, be operated at the bed side of a patient or any other suitable place. The display may, in certain embodiments, have remote connection to the rack, or may store received information until a further inter-action with the rack, e.g. when it is positioned in the vicinity of the rack, or is plugged into the rack. It is particularly preferred that the display is configured to provide an interface and/or a functionality for one or more of the following tasks: Verification of patient identity. This can, for example, be performed via measuring or receiving biometric data directly from the patient. This may alternatively also be done via using a patient's data carrier such as a smart cart, a mobile device or a wearable such as, for example, a bracelet. Also envisaged is the use of cloud-registered information or of intranet registered information. The patient may, for example be identified via an iris scan, a fingerprint, an implanted chip in his body, a bracelet comprising information or via face recognition.

Acoustic operator guidance and/or receiving of acoustic commands. This activity may be performed with the above described electronics and microcontroller elements in the display. The guidance may follow a locally installed program or be derived from cloud-based servers. The guidance may, in preferred embodiments, be provided by virtual assistant technology and include machine learning modules, e.g. in a cloud-based environment which is connected to the display. Also envisaged are far-field audio and signal processing units which help to interpret received acoustic command and comments. Also envisaged is the use of wake word detection, which may activate the display by uttering a signal word known to the operator and Natural Language Understanding (NLU) for converting text into meaningful representations, as well as text-to-speech technology providing the text which is to be provided to the operator, preferably based on Natural Language Generation (NLG) algorithms.

Verification of operator identity. This can, for example, be performed via io measuring or receiving biometric data directly from the operator. This may alternatively also be done via using an operator's data carrier such as a smart cart, a mobile device or a wearable such as, for example, a bracelet. Also envisaged is the use of cloud-registered information or of intra net registered information. The operator may, for example, be identified via an iris scan, a fingerprint, an implanted chip in his body, a bracelet comprising information or via face recognition. The obtained information may further be compared with database entries on the operator e.g. his shift, his employment status, his qualification, his supervisor, his reliability etc. Inputting of analytic orders or assignments. This task may be performed either by providing sound commands or by inputting order as text, e.g. via a keyboard, preferably a virtual keyboard on the display. The received orders or assignments may be linked to the sample containers and/or relayed to further steps in the analytic chain, e.g. analysis sites, transport service units etc. In certain embodiments, the inputting or communication procedure may comprise the entire coverage of a laboratory order or may include a linkage to an order entry software or functionality at the lab site. It may accordingly be inquired which sample shall be analyzed with which test. The procedure may further include a shortlist for typical or important tests or functions. This list may, in additional embodiments, be adapted to changed circumstances via machine learning algorithms.

Fetching of electronic health records. This task may be performed via inquiries at databases connected to the display, e.g. in a hospital or in private practice, in a cloud-bases server. The electronic health records may further be checked and compared with the obtained patient identity and information on previous sample collections, registered diseases requiring specific analytics etc. The task may further include the possibility of editing or changing the electronic health record, e.g. via an input at the display.

Outputting of performed steps within the stationary sample container rack. This task allows the operator to see in which phase of the pre-analytic checking the io sample is at the moment. For example, the passing of checkpoints or the passing of predefined time segments may be shown to the operator, preferably also combined with acoustic alarm elements such as beeps or jingle elements. The task may further include interactive elements which require the operator to authorize further steps, e.g. by pressing a virtual or physical button or the like, or by giving acoustic commands.

Outputting of steps to be performed outside the stationary sample container rack. This task refers to steps which are connected, for example, to the transport of the sample containers, the analytic phase at an analytic site, the finishing of said analysis, report generation or diagnostic interpretation or therapeutic decision making etc. Also this task may, in certain embodiments, further include interactive elements which require the operator to authorize further steps, e.g. by pressing a virtual or physical button or the like, or by giving acoustic commands.

Confirmation of performed steps within the stationary sample container rack and/or feedback on said steps or lack of said steps. This task provides the operator with an overview of the status of pre-analytics in the rack and may also allow for feedback and interaction in case of non-finishing of certain activities or quality problems etc. Confirmation of steps to be performed outside the stationary sample container rack and/or feedback on said steps or lack of said steps. Similarly, also outside activities may be provided to the operator and require feedback and interaction from him.

Additionally or alternatively, the task of mapping with external order may be performed. Accordingly, received data from the registration process may be compared with order information, sample container type information, e.g. barcodes, optionally also be verified with patient information. For example, the sample container type may be compared with the order, or the barcode may be compared with the order, or the patient identity may be compared with the order etc. Also envisaged is the check for completeness of the order or associated documents. The mapping may be performed with the stationary sample container rack, e.g. in the display unit, or it may be performed in a remote receiving station, e.g. a cloud-based server. The mapping may result in a feedback to the operator of the rack.

Additionally or alternatively, the task of mapping with internal databases may be performed. Such mapping procedure may include the connection of a sample container type with a mixing, centrifugation or filling volume requirement etc. The mapping may be performed with the stationary sample container rack, e.g. in the display unit, or it may be performed in a remote receiving station, e.g. a cloud-based server. The mapping may result in a feedback to the operator of the rack.

Additionally or alternatively, the task of providing a feedback to the operator in accord-ance with pervious steps, mapping results, alerts etc. The envisaged setup allows for a reaction of the operator, an acknowledgement by the operator or an overruling, e.g. by actively pressing a button etc. (ii) A sample container loader. This component is designed to receive one or more sample containers from an entry point and to move them to a first section of the rack. The loader may be a mechanic component, e.g. a mechanic sample container displacement and manipulation unit, designed to move or reposition a sample container as defined herein, or an independent robotic component. Also envisaged are carriage components. The sample container loader may, for example, be capable of loading several sample containers at once, e.g. between 2 to 200 sample containers.

(iii) A sample container registration unit. This unit maycomprise anysuitable component which allows to identify a sample container. In a preferred embodiment, the unit is an s optical detection unit. Particularly preferred are a camera or a spectroscope. In one em-bodiment of the invention the sample container registration unit has the form of a master check-in slot. The term "master check-in slot" as used herein relates to at least one sample container slot within the stationary sample container rack, which is configured to check one or more parameters of a sample container. This checking may, for example, io be performed between the step of filling the sample in the container and subsequent pre-analytic steps such as mixing or centrifuging etc. It is preferred that the checking is performed immediately after the sample container is filled with the sample or after a pre-treatment of the sample in the container is finished. The master check-in slot is preferably suited to check one or more parameter(s) as mentioned herein. Accordingly, the is master check-in may be a specific slot in the rack equipped with suitable sensors, a cam-era, a scanner unit, an RFID unit etc., as mentioned herein to detect one or more parameter(s) as mentioned. The one or more parameter(s) to be checked may preferably comprise the identity of the sample and/or sample container, the type of sample container, preferably identifiable via a color code, e.g. a cap color code, and/or shape, the volume of a sample container, preferably identifiable by shape, the filling volume of the sample container, the sample number, the temperature of the sample and/or of the sample container and/or of the sample container rack, e.g. in the slot, preferably at the time point of sample container placement in the sample container rack, the humidity of the sample and/or in the sample container, time parameters of the sample container rack's use, an index of the sample relating to hemolysis, icterus or lipaemia, e.g. via a color detection as defined above, the centrifugation status of the sample, the presence of a liquid and/or solid phase and/or of a separating gel layer in the sample, the ratio of liquid and solid phases in the sample; and one or more quality parameters of the sample, preferably pH, ionic concentration, and presence of apoptotic, inflammatory or infectious indicators. If an order form is attached to the sample container, an image of the order form may be captured in the mater check-in slot by a camera or scanner unit. The obtained parameter values or the information on the status of the sample or sample containers or the sample container rack may be stored with the module or be transmitted s to a remote receiving station via a wireless and/or real-time communication, e.g. peri-odically or triggered by an event.

(iv) A sample mixer unit. The sample mixer unit may, for example, be a shaker or vibrator unit. It may also be a unit capable of vortexing the sample, or of rolling the sample container. Also envisaged are high shearing mixing units, blood roller mixers, three-dimen-siona I rotating mixers, kneaders or multi tube mixers. The frequency and/or velocity of the mixers may be adjustable, e.g. via the display unit as described herein. The sample mixer unit may be configured to mix in accordance with sample container types, the order of appearance etc. The sample mixer unit may be used or operated in accordance wit the previously determined properties of the sample or sample container and/or in-formation on the sample, sample container or patient or test to be performed derived from a remote receiving station, e.g. a cloud-based server or database.

(v) A centrifugation unit. The centrifugation unit may perform simple or complex centrifugation steps. Typically, a clinical blood centrifuge is envisaged. The centrifugation unit may be coolable or heatable. Also envisaged are vacuum centrifuges. The centrifu-gation unit may be configured to operate in accordance with sample container types, the order of appearance etc. The centrifugation unit may be used or operated in accordance wit the previously determined properties of the sample or sample container and/or information on the sample, sample container or patient or test to be performed derived from a remote receiving station, e.g. a cloud-based server or database.

(vi) A sample sorting unit. This unit is designed to automatically sort and separate sample containers according to pre-defined rules, e.g. according their nature, their processing or pre-analytic status, their envisaged storage time and status, their quality status, their final or intermediate destination, their form or shape, their cap color, their temperature, the amount of time which has passed since arrival, request or orders etc. The sorting may further lead to a storage of samples, a transport of sample containers, e.g. via a mobile sample container rack as described herein or by using a pneumatic tube system. Sorting steps may be registered and, in specific embodiments, be verified by the opera-tor. The surveillance may, for example, be performed by taking images or the process and subsequently interpreting said images. The sample sorting unit may be used or operated in accordance wit the previously determined properties of the sample or sample container and/or information on the sample, sample container or patient or test to be performed derived from a remote receiving station, e.g. a cloud-based server or data-base. In certain embodiments, the operation of mixing, centrifugation and/or sorting unit may be coordinated, e.g. in accordance with the above mentioned options.

(vii) A sample storage unit. This unit is configured to store and, in certain embodiments, refrigerate or freeze samples or sample containers. The unit may, for example, store the sample containers until a new mobile sample container rack is connected, or until fur-is ther sample containers with the same destination, the same ordered analysis, the same quality status, the same patient etc. have been accumulated. The storage unit may be a specific subsection of the rack which is equipped with heating or cooling devices. The storage may be performed according to the nature, processing or pre-analytic status, envisaged storage time and status, quality status, final or intermediate destination, form or shape, cap color, temperature, the amount of time which has passed since arrival, request or orders etc. of the sample containers or samples.

[0050] The above described units or elements may be present in any suitable combination in the stationary sample container rack according to necessities. For example the stationary sample container rack may comprise one or more than one of these units or elements, e.g. 2, 3, 4, 5, 6 or 7. The present invention envisages any combination of these elements or units. In certain embodiments, the stationary sample container rack comprises at least the display for input and/or output operations and one or more of the other elements or units.

[0051] It is preferred that the said stationary sample container rack is connectable to one or more mobile sample container rack(s) for transport. The term "mobile sample container rack" as used herein refers to sample container rack which is designed as smart transport vehicle for sample containers. It may accordingly accommodate sample containers in a tight and anti-slip manner. In further embodiments, the mobile sample container rack may additionally be packed in a further secondary box, e.g. a polystyrene box or any other suitable material. It is preferred that the secondary box is accurately fitting the mobile container rack to avoid any displacement. Also envisaged are additional packages such as bags or crates. The use of these packaging variants may depend io on the delivery route, the environmental temperature, the transport medium, the transport time etc., and may accordingly be adjusted.

[0052] The mobile sample container rack may, in certain embodiments, have the form of a drawer or collection container, which can be placed below the stationary rack. Accordingly, the mobile rack may not be sealable or have no lid or cover.

[0053] In further, specific embodiments of the present invention, the mobile sample container may have the form of a flexible bag or pouch, e.g. a plastic, paper or textile bag. The bags or pouches may alternatively be plastic or metal boxes for manual transport, e.g. within a hospital. The bags, pouches or boxes may be sealable, amenable to sterile handling and/or to automatization, e.g. in the context of an hospital delivery system. The samples in the sample containers as described herein may accordingly be registered, processed, labelled etc. as described herein. Subsequent to a sorting step, the sample container may be placed or delivered to one or more bags, pouches or boxes as described above. The bags, pouches or boxes may, for example, be coded with different colors, different destination codes, different content codes or the like.

[0054] It is further envisaged that the mobile sample container rack has an accurately fitting form or interface for sample analyzers or sample analyzer systems, or sorting machines connected to said systems or loading machines connected to said systems. The mobile sample container racks may accordingly be configured to additionally have form and functionality which allows for automated opening upon arrival at the sample analyzer system or associated modules as described herein.

[0055] In further embodiments, the mobile sample container rack may be provided as carrier for a pneumatic tube system. Accordingly, the mobile sample container rack may s have the form and functionality of a pneumatic tube system container, i.e. have typically round form to accommodate one or more sample container, e.g. between 1 and 5 sample containers. In further embodiments, the pneumatic tube system container/mobile sample container rack may comprise an inlay which comprises one or more slots for sample containers. In further particularly preferred embodiments, the pneumatic tube io system container comprises one or more sensors designed to register temperature and/or acceleration data and/or time conditions of the pneumatic tube system container. These sensors may be connected with the stationary sample container rack, or with a remote receiving station as described herein below.

[0056] The connection between the mobile sample container rack and the stationary is sample container rack may be implemented in the form of suitable adaptors. For exam- ple, a mobile sample container rack may be linked to a stationary sample container rack via mechanic or magnetic holdings or clamps. The adaptor may further comprise an electric and/or data connection between the mobile sample container rack and the stationary sample container rack. Further envisaged are adaptors which integrate the station- ary sample container rack into a pneumatic tube system. In corresponding embodi-ments, the adaptor and the pneumatic tube system are configured for automatic loading and/or sending of pneumatic tube system containers/mobile sample container racks.

[0057] In specific embodiments the mobile sample container rack may comprise at least one, preferably more than one of the following: (i) One or more unit(s) for contactless communication with a base station. For example, it may comprise an RFID (radio frequency identification) unit, preferably an RFID reader, which allows to communicate with an RFID component or tag present at or in the sample container, or at or in the stationary sample container rack. The RFID reader accordingly is designed to detect the presence of each sample container placed in the rack. It may communicate sequentially or simultaneously with all sample containers. Furthermore, the information encoded in the sample containers, e.g. in the tag, as to origin, patient identity, sample type etc., may be received by the reader. The reader may further de-termine whether all positions in a rack are filled and/or which positions are vacant. The sample container rack may also comprise an NFC (near field communication) unit or a Bluetooth unit, preferably a Bluetooth device. Furthermore, the sample container may comprise an ID-chip unit. In a preferred embodiment the mobile sample container rack lo is capable of communicating, e.g. on the basis of the above mentioned communication means, with a sample analyzer and/or remote receiving station and/or LIS or other system. The mobile sample container rack may accordingly be configured to autonomously contact said sample analyzer system or the like upon arrival or upon laboratory entry, to negotiate data exchange, to transfer data, e.g. about the samples, patients, trajectory etc. to the sample analyzer system or LIS or local sever etc., or to a remote receiving station. Furthermore, the mobile sample container rack may be configured to be resetted by the sample analyzer system or LIS or remote receiving station upon data transfer and delivery of sample containers. Such a procedure may be followed by a reuse for further transportation.

(ii) A device for determining the temperature of the sample container, preferably a de-vice which allows to determine the temperature at different positions, e.g. the outside and inside of a sample container. Also envisaged is a device for determining the humidity of the mobile sample container rack.

(iii) A device capable of determining vibrations and centrifugal forces exerted on the mobile rack and/or the sample container provided in the rack. This device is preferably capable of registering, documenting and categorizing vibrations and/or gravitational changes, e.g. due to pressure changes, downfalls, fast horizontal or vertical movements etc. An example of a suitable sensor is a piezoelectric device.

(iv) A geographic tracking device. This device is designed to register and document geographic changes of the mobile sample container rack. Preferably, a GPS sensor system may be used to track geographic positions. The Global Positioning System (GPS) is a space-based radionavigation system operated by the United States Air Force. It is a global navigation satellite system that provides geolocation and time information to a GPS receiver anywhere on or near the Earth where there is an unobstructed line of sight to four or more GPS satellites. The GPS does not require the user to transmit any data, and it operates independently of any telephonic or internet reception, though these technologies can enhance the usefulness of the GPS positioning information. The GPS io provides critical positioning capabilities to military, civil, and commercial users around the world. The present invention further envisages the use of alternative geolocation systems such as Galileo, Glonass, GSM triangulation or Beidou. In specific embodiments, more than one geolocation may be used.

(v) A device capable of determining time parameters of the mobile sample container is rack's use. The device may, for example, register the time and date of a placing of a sample container in the mobile rack and its removal. It may further register the beginning and/or ending of movement phases, e.g. in combination with the geographic tracker and/or the vibrational sensor as described above. Furthermore, beginning and course of temperature changes may be determined, e.g. in combination with the tem-perature determining device.

(vi) A communication module, which allows for wireless communication with a remote receiving station or with a stationary sample container rack. This communication module is, in certain embodiments, based on high-speed wireless communication standards such as LTE (long-term evolution), or GSM/EDGE or UMTS/HSPA technologies, or any other suitable high-speed wireless communication technology or standard, e.g. also technologies which will be developed in the future, or are not yet commercially available such as 5G or successors thereof. It is preferred that the communication module allows for real-time communication with a remote receiving station. The communication may preferably be connected with all other modules in the mobile sample container rack or the stationary sample container rack and thus collect and transmit data from the modules present to the remote receiving station. The communication module may, in further embodiments, also be equipped with a second or further communication module, e.g. a WiFi or WLAN module for local data transfer in a surrounding which provides suitable receiving possibilities. In alternative embodiments, the communication module may be capable, or may additionally be capable of transferring data with further protocols such as NarrowBand IOT (NB-IoT). NarrowBand loT (NB-loT) is a Low Power Wide Area Network (LPWAN) radio technology standard developed to enable a wide range of devices io and services to be connected using cellular telecommunications bands. NB-IoT is a nar-rowband radio technology typically designed for the Internet of Things (loT) and is one of a range of Mobile loT (MloT) technologies standardized by the 3rd Generation Partnership Project (3GPP). The present invention further envisages the use of similar technologies such as eMTC (enhanced Machine-Type Communication) and EC-GSM-IoT. In further embodiments, the communication module may further be capable of receiving information form a remote receiving station or a stationary sample container rack, e.g. with respect to encoded patient information, sample shipping destinations, etc. (vii) A light sensor module. This module may determine light intensity on or in the vicinity of a sample container. The use of this module is particularly advantageous in case of light sensitive samples. In certain specific embodiments, a light sensor module may be present on the sample container directly, thus allowing for a light intensity check at the first moment of filling the sample. In further embodiments, the light sensor module may be present in or on the sample container, as well as in the sample container rack. In further embodiments, the device is capable of detecting the opening or closing of the sample container rack.

(viii) A digital memory module. This memory module may collect and store information from one or more of the above mentioned modules (i) to (v) or (vii). It may serve as documentation center for the mobile sample container rack during travelling or transport periods. The digital memory module may further be closely connected to the communication module (vi) and provide information to be sent out to a remote receiving station. Also envisaged is a data processing unit.

(ix) An acoustic and/or optical alarm module. This module may serve as signaling center s for the mobile sample container rack during travelling or transport periods informing about an abnormal status of samples in the mobile sample container rack. The incoming alerts may be received as alarm tones or a visual signal such as a flashing lamp. The acoustic alarm module may be configured to provide a direct acoustic alarm at the rack, or it may be configured to send an acoustic alarm signal to connected devices such as a handheld device, smartphone or the like. The optical alarm may be implemented as color LEDs on the rack. Also envisaged is a combination of acoustic and optical alarm options such that an alarm is provided acoustically and at the same time optically. The alarm module further comprises a switch or similar element which allows to terminate the alarm, e.g. after the cause of the alarm has been eliminated, or independent of such is an elimination.

(x) An electric power source. In order to be operational, the mobile sample container may have its independent electric power source. This may, for example, be a battery or a rechargeable battery. In further embodiments, the electric power may be provided externally, e.g. by wireless power transfer (WPT) or wireless energy transmission. These technologies use different types of electromagnetic energy, including electric fields, magnetic fields, radio waves, microwaves or infrared waves. In a WPT scenario, a transmitter module may be present in the vicinity of a sample container rack. This technology may further be used to recharge batteries of a mobile sample container rack during recovery periods or in a magazine. The power source may be used for the support of one or more of the above mentioned module(s), e.g. the communication, tracking, memory, and interaction modules or the alarm modules.

(xi) The mobile sample container rack may further itself be provided with an identifier. For example, the sample container rack may comprise a barcode, or a matrix code, or alternatively an RFID tag or NFC tag, or an electronic code such as flash memory, EPROM or EEPROM.

[0058] In further specific embodiments, the mobile sample container rack may be equipped with one or more effector modules, e.g. a heating or cooling device, which s allows to increase, decrease or keep a predefined temperature. For example, a temper-ature of -80°C, -70°C, -60°C -50°C, -40°C, -30°C, -20°C, -10°C, -5°C, 0°C, 4°C, 6°C, 10°C, 15°C, 20°C, 25°C, 30°C, 33°C, 35°C, 37°C or any other suitable temperature. The effector module may, for example, become active once a certain parameter is detected outside of a predefined range, e.g. the temperature is detected to be too high or too low. The io power source as defined above may also be supportive for such an effector module. In a further embodiment, the sample container rack is a passive rack, which comprises insulations and/or an airtight cover in order to keep a predetermined temperature (within a suitable range or corridor) during the transport of the sample containers.

[0059] As used herein, a "sample container" may be any suitable receptacle which is is capable of comprising and storing a biological or medical sample. The container may be designed to comprise or store liquid or non-liquid materials. If liquid materials are comprised and stored, the container may be designed to be impermeable for the liquid. If non-liquid materials are comprised or stored, the container may be designed to accommodate as much of the material at the available space as possible. In further embodi- ments, the container may further be air-tight so that a gas exchange with the surround-ing is avoided. The container may, in certain embodiments be completely empty before a sample is filled in. It is particularly preferred that the container is sterile. In further embodiments the container may be provided in a form or designed to allow for the generation of vacuum in the container after filling.

[0060] The sample container may be composed of any suitable material. Typically, the container may be composed of glass or plastic material, or a combination thereof. Also envisaged is the use of metals and/or electronic components, e.g. integrated into the container. The material and form of the container may further be adjusted to specific national or international regulations as to its properties, size, form etc. [0061] For example, the container may comprise, before any sample is filled in, a reagent or compound. For example, the container may comprise a stabilizing agent, which s assists in preserving the sample. In further embodiments, the container may comprise reagents necessary for carrying out one or more biochemical assay(s) such as a buffer, nucleotides, an enzyme, a dye, etc. In yet another embodiment, the container may comprise an element, which allows to molecularly identify or characterize or tag a sample. For example, a molecular tag such as an artificial DNA sequence which can be retrieved io and identified may be present in the container. Alternatively, an electronically identifia-ble particle may be provided in the container. These elements can either be filled in before the sample is added, or together with the sample or after the sample has been filled in. The sample container may further be chemically inert, e.g. composed of chemically inert plastics material. In a further embodiment, the container may be provided as is insulated container designed to keep the sample at a predefined temperature range and avoiding a freezing or cooking of the sample. In other embodiments, the present invention also envisages sample containers for cold transport at very low temperatures, e.g. temperatures below 0°C, -5°C, -20°C, -30°C, -40°C or deeper. The sample container may be provided in any suitable size. The size may be determined by the sample type to be comprised, the purpose of the sample taking, e.g. diagnostics, documentation, storage, the number of assays planned with the sample, etc. Typically, sizes in the range from 5 ml to 50 ml are envisaged, e.g. 5 ml, 7.5 ml, 10 m I, 12 ml, 12.5 ml, 15 ml, 20 ml, 25 ml, 30 ml, 35 ml, 40 ml, 45 ml, 50 ml. In certain embodiments, also sizes smaller than 5 ml or larger than 50 ml are envisaged.

[0062] In a preferred embodiment, the sample container is a blood or processed blood collection container. Accordingly, the sample container is designed to fulfil all necessary regulatory requirements for blood transport, storage and/or diagnosis. The container may further be designed to alternatively comprise parts of a blood sample or a processed blood sample, e.g. a plasma or serum sample. In a further preferred embodiment, the sample container is a biopsy collection tube. Accordingly, the sample container is designed to fulfil all necessary regulatory requirements for biopsy transport, s storage and/or diagnosis. In yet a further group of embodiments, the sample container is a container or tube designed to receive a biological fluid such as urine, semen, sweat, sputum, saliva, feces or stool. Accordingly, the sample container is designed to fulfil all necessary regulatory requirements for transport, storage and/or diagnosis of a biological fluid such as urine, semen, sweat, sputum, saliva, feces or stool. The present inven-tion further envisages the collection and transport of any other biological, medical or chemical sample type, e.g. water samples from environmental tests, microbial samples from environmental or epidemiological tests, scientific samples to be provided to remotely locate working groups, geological samples, archeological samples, etc. [0063] According to the invention, the sample container is additionally equipped with a is unit for contactless communication with a base station. A "base station" in the context of the contactless communication means a stationary sample container rack or a mobile sample container rack as defined herein. The term "unit for contactless communication" relates to an electronic or computerized element, which either actively sends out a signal to a base station, or works passively and may react to a signal generated by a base station. In both scenarios, the signal may be transmitted without direct physical contact between the sample container and a base station, e.g. via radio waves. In preferred embodiments, the unit for contactless communication is based on RFID (radio-frequency identification) technology. The RFID technology uses electromagnetic or electrostatic coupling in the RF portion of the electromagnetic spectrum to transmit signals. RFIDs may generally be classified as active or passive. Active RFID systems typically have 3 components: (a) a reader, transceiver or interrogator, (b) antenna, and (c) a transponder or IC programmed with information. Active RFID tags typically possess a microchip circuit (transponder or integrated circuit (IC)) and an internal power source, e.g. a battery, and when operably connected to an antenna, the active RFID tag transmits a signal from the microchip circuit through the power obtained from the internal battery.

[0064] Typically, active RFID tags such as transponders and beacons are used. In one example, a system may use an active transponder. In this scenario, the reader sends a s signal and when the antenna and tag are operably connected, the tag will send a signal back, e.g. with the relevant information programmed to the transponder. In a different scenario, an active beacon is used wherein the beacon sends out a signal on a periodic basis and it thus does not rely on the reader's signal.

[0065] In contrast to active systems, passive RFID systems comprise (a) a reader, trans- ceiver or interrogator, (b) antenna, and (c) a tag programmed with information. A pas-sive RFID tag typically includes a microchip or integrated circuit (IC), and it may contain the antenna as an integral component of the tag or as a separate device. In passive systems, the tag typically does not include a power source. In one example, the antenna can be an internal component of the tag, i.e., the antenna and IC can be contained in a is single device. However, until operably connected in the device, the antenna and IC may not interact. Alternatively, the antenna and IC may be provided on separate components. Typically, passive tags wait for a signal from an RFID reader. The reader thus sends energy to an antenna which converts that energy into an RF wave which is transmitted into the read zone. Once the tag is read within the read zone, the RFID tags internal antenna is typically powered via RF waves. Accordingly, the tags antenna fuel the IC with energy which generates a signal back to the RF system. Such process of change in the electromagnetic or RF wave, can advantageously be detected by the reader (e.g. via the antenna), which may in turn interpret the information. Accordingly, passive RFID tags have typically no internal power source and normally comprise an IC and an internal antenna. The tag may, in specific embodiments, comprise an electronic product code (EPC) or a similar code, which is a 96-bit string of data. Also envisaged are alternative codes, which allow to identify a product or element.

[0066] The RFID tags may be used at different frequencies, e.g. at a low frequency (LF) of 125-134 kHz, at a high frequency (HF) of 5-7 MHz, at a HF and Near-Field Communication (NFC) frequency of 13.56 MHz, at an ultra-high frequency (UHF) of 433 MHz, 865868 MHz, 902-928 MHz, or in the Giga Hertz band of 2.45 to 5.8 GHz. It is preferred to make use of a frequency at or around 13.56 MHz.

[0067] In a preferred embodiment, each sample container comprises a passive RFID tag which operates at a unique frequency so that each sample container is distinguishable from the other sample containers. If there is more than one sample container in contact with a base station, the frequencies may be read sequentially or simultaneously. To io avoid collision between individual tags, collision detection may be used. To this end, typically two different types of protocols are used to singulate a particular tag, allowing its data to be read in the midst of many similar tags. For example, in a slotted Aloha system, a reader may broadcast an initialization command and a parameter that the tags individually use to pseudo-randomly delay their responses. Alternative, an adaptive bi-is nary tree protocol may be used, wherein the reader sends an initialization symbol and then transmits one bit of ID data at a time. In this scenario only tags with matching bits respond, and eventually only one tag matches the complete ID string.

[0068] In preferred embodiments, the NFC (near field communication) is used for the RFID coupling. NFC is a set of short-range wireless technologies, typically requiring a separation of 10 cm or less and operates at 13.56 MHz on ISO/IEC 18000-3 air interface and at rates ranging from 106 kbit/s to 424 kbit/s. NFC typically involves an initiator and a target; the initiator actively generates an RF field that can power a passive target. This enables NFC targets to take very simple form factors such as unpowered tags or stickers. NFC tags typically contain data and read-only, or may be writeable. It is preferred that the tags are custom-encoded. Tags may comprise different memory sizes, e.g. between 96 and 4,096 bytes of memory.

[0069] The RFID or NFC component or tag used to identify the sample container may either be integrated into the container itself, e.g. its wall or cap, or be attached to the sample container, e.g. at the outside or inside of the container, or in a further alternative, it may be provided within the sample to be filled in the container, e.g. as inert and/or sterile particle tag, which is present e.g. in a blood or other liquid sample, or which is added to a biopsy sample during the or after or before the process of filling the sample into the container. The RFID or NFC component or tag may preferably be pro-vided in the form of a sticker or adhesive label.

[0070] In addition to one or more RFID component(s), the sample container may comprise a further identifier. Examples of envisaged identifiers include a barcode, a matrix code, or an electronic code such as flash memory, EPROM or EEPROM. In certain em-bodiments, the RFID or NFC component or tag may be integrated into the barcode or matrix code. For example, the barcode or matrix code may be provided in the form of a sticker or an adhesive label, which may additionally comprise the RFID or NFC tag functionality.

[0071] In a preferred embodiment, the unit for contactless communication is based on Bluetooth technology. Bluetooth is a wireless technology standard for exchanging data over short distances using short-wavelength ultra-high frequency (UHF) radio waves in the industrial, scientific and medical (ISM) radio band from 2.400 to 2.485 GHz from fixed and mobile devices, and a building personal area networks (PANs).

[0072] It is particularly preferred that the stationary and mobile sample container racks are capable of direct communication with each other. Such a direct communication may be cable, magnetic or optical connection. For example, both racks may be connected via a LAN cable or a similar cable. In further preferred embodiments, the stationary and mobile sample container racks are capable of direct communication with each other via contactless communication. Said contactless communication may further also be estab- lished with a remote receiving station. The contactless communication may be imple-mented with any suitable unit known to the skilled person, preferably a unit as described herein. For example, the unit may be configured for data transmission such as an RFID unit, an NFC unit, a GSM, LTE or G5 unit, a LPWAN unit, a LoRaWAN unit, a Bluetooth unit or a WiFi unit as defined herein.

[0073] In further preferred embodiments, the stationary sample container rack may be connectable more than one mobile sample container rack. For example, each stationary s sample container rack may be connected to 2, 3, 4, 5, 6 or more mobile sample container racks. These mobile racks may have identical functions and accordingly be filled in the order of processed samples, or they may have different functions, e.g. be directed to different destinations, comprise different types of samples, e.g. serum, blood, plasma etc., comprise erroneous samples or sample containers, comprise sample containers io designated for different analyses, require different environmental conditions, e.g. dif-ferent temperatures, different vibrational contexts, are or are not light sensitive, or the samples may have different degrees of pre-analytic measurement, e.g. have been mixed or centrifuged before, or not, or have been analysed with respect to certain parameters such as pH, ionic concentration, and presence of apoptotic, inflammatory or infectious is indicators, or with respect to the presence of hemolysis, icterus or lipaemia, or for sam-ple containers distinguishable by different cap colors.

[0074] In further embodiments all or some of the differential functions mentioned above may be reflected by zones or sectors within one mobile sample container rack. For example, a mobile sample container rack may comprise specific, e.g. separated zones or sectors, to receive: sample containers directed to different destinations, com- prising different types of samples, e.g. serum, blood, plasma etc., sample containers comprising erroneous samples, sample containers designated for different analyses, sample containers or samples which require different environmental conditions, e.g. different temperatures, different vibrational contexts, are or are not light sensitive, or sa m-ple containers, wherein the comprised samples have different degrees of pre-analytic measurement, e.g. have been mixed or centrifuged before, or not, or have been analysed with respect to certain parameters such as pH, ionic concentration, and the presence of apoptotic, inflammatory or infectious indicators, or with respect to the presence of hemolysis, icterus or lipaemia, or sample containers distinguishable by different cap colors.

[0075] In further very preferred embodiments the stationary sample container rack additionally comprises one or more of the following: s (i) A sample container reservoir. The reservoir may receive empty sample containers or defect sample containers. It may be managed with an automated sample container selection mechanism.

(ii) A label printer unit. The label printer unit may print adhesive labels for sample containers. The label may, for example, be a barcode or OR-code label, or a text label or io comprise both. The labels may be provided in form of a roll or in pin box. The label printer unit is preferably directly connected to a sample container labelling unit.

(iii) A sample container labelling unit. This unit is capable of labelling sample container with printed or otherwise obtained label. Typically, a rolling mechanism is used, wherein the adhesive label is place on a sample container which is subsequently rolled on active and passive main or secondary rollers.

(iv) An incubation unit. The incubation unit may be implemented as open or closed entity with the rack. The incubation unit may provide a pre-defined temperature, e.g. 37°C, 25°C etc., a pre-defined humidity, a pre-defined light exposure etc. Furthermore, the incubation unit may be equipped with slots for one or several sample container. The sample containers may be entered in a batch or continuously. Furthermore, mixing or shaking units may be presence. Furthermore, the incubation unit may comprise units which are capable of inserting or adding one or more reagents to the sample, i.e. into the sample container.

(v) A storage unit. This unit is configured to store and comprise consumables, reagents, enzymes etc. which are used for the performance of the pre-analytic analyses according to the present invention. The unit may, in certain embodiments, comprise an active heating or cooling device, a temperature control unit and may be connected to a mechanic as describe herein, which allows to move the reagents etc. to their place of operation.

[0076] In further preferred embodiments the stationary sample container rack addition-ally comprises one or more of the following: (i) A sensor device for monitoring, preferably for determining the temperature of the sample container and/or of the stationary sample container rack and/or the environmental temperature and/or of the mobile sample container rack, preferably per individual sample container slot within the stationary sample container rack, a device for de-termining the humidity of the stationary sample container rack and/or of the mobile sample container rack, a light sensor and/or device capable of detecting the opening or closing of the stationary sample container rack and/or of the mobile sample container rack.

(ii) A machine learning and data processing unit. This unit is preferably configured to perform one or more of the following tasks: automatized evaluation of sample registration data and/or measured parameters, preferably of image data; autonomous calculation of key performance indicators (KPIs) or quality indicators obtained during one or more pre-a nalytic activities within or outside the stationary sample container rack; autonomous generation of system or user feedback on the basis of calculated KPIs; autonomous identification and marking of erroneous or defect samples and/or sample containers; and comparison of measured data or parameters with a data or parameters derived from a database, preferably an internal database. The unit may make use of suitable machine learning or Al algorithms known to the skilled person. For example neural networks such as CNNs or DCNNs may be used. The machine learning approach may preferably be based on image recognition algorithms.

The machine learning and data processing unit may further be used for one or more of the tasks mentioned above in the context of the interactive display. For example, the coverage of a laboratory order or a linkage to an order entry software or functionality at the lab site may be implemented. Additionally or alternatively, a mapping with external order may be performed. Accordingly, received data from the registration process may be compared with order information, sample container type information, e.g. barcodes, optionally also be verified with patient information. For example, the sample container type may be compared wit the order, or the barcode may be compared with the order, or the patient identity may be compared with the order etc. Also envisaged is the check io for completeness of the order or associated documents. Also the mapping with internal databases may be performed. Such mapping procedure may include the connection of a sample container type with a mixing, centrifugation or filling volume requirement etc. The mapping may be performed with the stationary sample container rack, e.g. in the display unit, or it may be performed in a remote receiving station, e.g. a cloud-based server. The mapping may result in a feedback to the operator of the rack. Also envisaged is the use and development of internal databases in the rack or of external databases at remote receiving station, e.g. a cloud-based server, wherein said databases are self-learning and autonomously optimizing based on pattern recognition of captured images or other parameters. The captures images or parameters may be the filling volume of sample containers. An example of such self-learning approach is the recognition that a certain test is normally performed by the patients. If the test is not ordered, a corresponding feedback is provided, or the provision of a shortlist of typical orders etc. Key performance indicators (CPIs) as mentioned above may be used advantageously for regulatory purposes or for auto-estimation purposes. The KPIs may be used as part of a quality management system or approach, or for accreditation purposes. By way of example, a KPI may be the filling status of a sample container or the index of the sample relating to hemolysis, icterus or lipaemia.

"Erroneous or defect samples and/or sample containers" as used herein may include crushed sample containers, torn or unreadable labels, or samples which show an inconsistency with information provided in an external order or the dataset stored in the database or on the cloud-based server.

s (iii) A point of care testing unit. This unit may have the function of a lab-on-a chip diag-nostics unit. For example, the lab-on-a-chip unit may be provided such that it is located in or near the sample container cap. It may alternatively be brought into contact with the sample in the container, e.g. by a suitable opening mechanism of the container, or in the vicinity of the sample container. The unit may serve to check one or more quality lo parameters of the sample, preferably pH, ionic concentration, and presence of apop-totic, inflammatory, metabolic or infectious indicators. In further embodiments, the labon-a chip diagnostics unit as defined above may also be present on the sample containers. A "point of care testing unit" is a device that integrates one or several laboratory functions typically in the form of a lab-on-a-chip (LOC) on a single integrated circuit of a is few millimeters to a few square centimeters to achieve automation and high-through- put screening. Typically, LOCs use microfluidics to handle small fluid volumes. The LOC component may advantageously be connected to the sample containers, whose content may accordingly be analyzed or partially analyzed directly in the stationary sample container rack. For example, a small portion of the sample may be separated from the sa m- ple container and transferred by microfluidics to a LOC module, where one or more bi-ochemical or diagnostic assays may be performed. The LOC module may advantageously be used to determine and characterize clinical chemistry, immunological, or haematological parameters, or to determine or characterize disease indicators such as tumor markers, circulating DNA or RNA, or to determine or characterize biochemical properties of a sample, e.g. clotting time or viscosity of the sample. Furthermore, the assays may relate to the quality control of the sample, by e.g. the determination of pH, the concentration of ions or quality indicators etc. Non-limiting examples of biomarkers for apoptosis may include cytochrome c, activated caspases (e.g. caspase 2, 3, 7, 8 and 9). Exam-pies of inflammatory indicators may include but are not limited to cytokines/chemokines (e.g. IL-la, IL-113, IL-2, IL-6, IL-8, IL-12, IL-12p40, IL-27, TNFa, or IFNy), serum amyloid A (SAA), and the like. Examples of infectious indicators may include, but are not limited to leucocyte count, erythrocyte sedimentation rate, CRP, PCT, IL-6, and the like.

Examples of metabolic indicators may include, but are not limited to Glucose, Lactate and the like. Examples of further health indicators may include, but are not limited to Troponin-T, GDF-15, Ethanol, Uric Acid and the like. Correspondingly obtained information may subsequently be stored in the memory module described above, and/or transferred to a remote receiving station via the communication module as described lo herein above.

(iv) An acoustic input and/or output module. This module may serve as signaling center for the stationary sample container rack informing, for example, about an abnormal status of samples in the sample container rack, or as microphone receiving commands or comments from an operator. The alerts may be conveyed in form of alarm tones. The is module may be configured to provide a direct acoustic alarm at the rack, or it may be configured to send an acoustic alarm signal to connected devices such as a handheld device, smartphone or the like. The acoustic imodule further comprises a switch or similar element which allows to terminate the alarm, e.g. after the cause of the alarm has been eliminated, or independent of such an elimination.

(v) A mechanic sample container displacement and manipulation unit. This unit is de- signed to move or reposition a sample container within the rack, or a connected component, preferably a mobile sample container rack and/or a pneumatic tube system. For example, mechanic systems such as [Wove or p-Move axis systems of Cybertron may be used. Also envisaged are robotic systems, which may have in addition to the me- chanic elements AI-governed intelligent movements components. It is particularly pre-ferred that the mechanic sample container displacement and manipulation unit is capable of performing modifications or changes to the shape of a sample container and/or to reduce the volume comprised in a sample container. For example, the mechanic sample container displacement and manipulation unit is configured to press out residual air from a sample container. In a particularly preferred embodiment, the sample container to be used in this embodiment is Sarstedt monovette tube comprising a handle element s which can be pressed into the container, e.g. via a mechanic sample container displace-ment and manipulation unit according to the present invention.

(vi) A unit for linkage to a patient file or patient order, configured for data transmission. This unit is configured to provide connection to a patient file or health record. Also envisaged is the connection to a patient order with respect to analyses to be performed.

io The unit is capable of data transmission, preferably via a technique as described herein.

(vii) A unit for linkage to a patient wearable, configured for data transmission. This unit may, for example, be configured to connect automatically to a bracelet or other type of wearable of a patient. It may download any suitable information from said wearable, e.g. for patient verification purposes or for purposes of determining suitable analytic is tests etc. or whether additional analysis steps or activities are required, whether further and/or different samples are required from a patient, whether the sample transport should or can be modified, preferably accelerated or decelerated. The information derivable from a patient's wearable may include, for example, the patient's identity, the patient's pulse, the patient's blood pressure, the patient's cardiac rhythm, the patient's blood glucose level, the patient's oxygen supply and/or the patient's stress status. These parameters are preferably determined in a predefined period of time, more preferably directly before, during or after the sample is taken. In a case a predefined limit or range or corridor in terms of a patient's pulse, the patient's blood pressure, the patient's cardiac rhythm, the patient's blood glucose level, the patient's oxygen supply and/or the patient's stress status is surpassed or underrun, the corresponding sample may be marked as unusable. In such a scenario, a further, new sample may be requested or taken at the patient. For example, the information derived from a patient's wearable may be combined, integrated and/or compared with information obtained from a point of care unit as defined herein. Accordingly, on the basis of the patient's data and the data determined with the point of care functionality in the stationary sample container rack or the sample container, a decision making process may be started, e.g. at the remote receiving station with respect to the next steps to be performed with a specific s sample, e.g. whether a new sample is required, or sample analysis can be started. The term "wearable" as used herein, relates to a miniature electronic device that is worn under, with, or on top of clothing. Typically, a wearable may be a smartwatch which is used at the wrist. Other examples include devices which monitor the eye, e.g. in the form of contact lenses or smart glasses, or can be worn at different parts of the body.

io Also envisaged is the integration of wearables into clothing, e.g. shirts or trouser (intel-ligent textiles), on-chest devices or smart necklaces. Further envisaged are implantable devices, which provide patient's information including associated with its location, e.g. under the skin.

(viii) A unit for linkage to a health information system, LIS/KIS/CPOE or KAS system, con- es for data transmission. The term "health information system" as used herein, re-fers to a comprehensive, integrated information system designed to manage all the aspects of health related operations, such as medical, administrative, financial, and legal issues and the corresponding processing of services. The system typically provides a common source of information about a patient's health history. The system typically keeps data in a secure place and controls who can reach the data in certain circum-stances. The term "LIS" or "Laboratory Information System" as used herein, refers to an information management system, typically comprising a complex of hardware and software components that support the management of collection, processing, storage, distribution, and information representation procedures used with information that has been obtained as a result of laboratory activities. Typically, the LIS comprises the one or more of the following functions: (i) enrolment of samples, i.e. the assignment or reception of a unique identifier and recording of information (e.g. customer, description of sample, security information, storage conditions, performed tests, costs, etc.); (ii) assignment of a sample to analysis, i.e. display of a list of all required tests in combination with monitoring of the execution of assigned analyses, or tracking of time; (Hi) process of analysis proper, i.e. tracking of reagents (for example type, batch lots, order numbers, etc.) equipment and laboratory personnel involved with the samples; (iv) manual or automatic input of results and statistical processing, whereby unusual results or results that fall outside the range may be marked (to avoid loss of data, back-up copies and emergency recovery may also be included; (v) verification and validation (e.g. by using audit trails); and (vi) generation of report forms (e.g. quality certificates, test protocols, and analysis certificates). A similar concept is the "KAS" or "Klinisches Arbeitsplatzsystem" which provides as a front-end the decentralized information access in its entirety io for the hospital staff at the respective workplace. The KAS is typically a part of the "1(15" or "Krankenhausinformationssystem'', i.e. the entirety of all information-processing units for processing medical and administrative data in the hospital. The term "CPOE" stands for computerized physician order entry and relates to a process of electronic entry of medical practitioner instructions for the treatment of patients under his or her care. A linkage as envisaged herein may be based on suitable interfaces with said sys-tems, e.g. a common data format or the like. Suitable software or hardware modules may accordingly be present in the rack according to the present invention.

(ix) A unit for linkage to an analyzer, configured for data transmission. The term "analyser" refers to a sample analyzer which is designed to receive one or more mobile sa m-ple container racks as described herein. The sample analyzer may further be equipped with an RFID reader. The analyzer comprises, in this embodiment, a communication module allowing for wireless and/or real-time communication with either the stationary sample container rack which is also equipped with a communication module, e.g. based on LTE or 5G transmission standards, or with a remote receiving station, e.g. a cloud based server as described herein, or with a sample analyzer system, preferably an LIS.

By communicating with the rack or the remote receiving station, any information concerning the sample container status, e.g. quality parameters etc. as mentioned above, as well as decisions take with respect to the further fate or steps to be performed with the sample may be provided to the analyzer. Accordingly, the analyzer is preferably equipped with a structure which allows to discard or destroy certain samples or sample containers, or to recheck certain quality parameters of a sample.

(x) A unit for patient biometrics recognition, preferably of a patient's fingerprints or iris. The unit may, for example, be capable of scanning a fingerprint, or an eye of a patient or any other person. Also, a comparison with deposited data, e.g. in a database may be performed by this unit. In a further embodiment, the unit may be capable of face recognition or of reading implanted chips.

(xi) A card reader. This unit may, for example, be used for the reading of security or smart cards, e.g. cards which provide information on a patient's identity.

(xii) A sample container transportation unit. This unit may transport, e.g. in a conveyor belt manner, samples within the rack. This may be connected to image taking procedures for determining one or more parameters regarding the quality of the sample.

(xiii) A balance, configured to determine individual sample container weights. This unit is capable of weighing and comparing weights of the sample containers. This infor-mation may be used for the loading of a mobile sample container rack as described herein.

(xiv) A cooling and/or heating unit. The unit may preferably be used for incubation or storage purposes.

(xv) A sample separation unit. This unit is preferably configured to separate liquid and solid components in a sample container in a centrifugation-free manner. In a particularly preferred embodiment, the separation unit is configured to separate liquid and solid components in a sample container by sedimentation or ultrasonication.

[0077] In further specific embodiments the stationary sample container rack as defined herein may additionally comprises one or more of the following: (i) A de-recapper unit. This unit is capable of de-capping sample containers as described herein. Such a procedure may be necessary when adding or removing portions from a sample, e.g. when adding reagents to the sample, or when aliquoting a sample into several sub-samples. The de-capper unit may be an automatic unit, e.g. a Thermofisher model, a Micronic model, or a Brooks Life Sciences model.

(ii) An aliquoting unit. This unit is configured to withdraw one or more sub-portion of the sample. These sub-portions may subsequently be placed in one or more further sample containers. The aliquoting may be performed with any suitable volume or in any suitable proportion.

(iii) A de-sealer unit. This unit is capable of de-sealing sample containers as described herein. Such a procedure may be necessary when adding or removing portions from a sample, e.g. when adding reagents to the sample, or when aliquoting a sample into several sub-samples. The de-sealer unit may be an automatic unit.

(iv) A physical link to an analyzer platform. The physical link may be provided in the form of a cable or magnetic connection. The embodiment is optional and requires that the stationary sample container rack and the analyser are in vicinity and that no transport is required to bring the samples from the site of collection to the site of analysis.

(v) A smartphone, internet, intranet or app interface. This unit allows for connection of the stationary sample container rack with suitable outside devices such as a smartphone, a table, or an internet program, a browser. Alternatively, also Intranet in-terfaces may be used, e.g. in a hospital environment. In further embodiments, the connection may be performed via an App which is capable of showing one, more or all elements as shown on the display as mentioned herein above.

[0078] In a further aspect the present invention relates to a system comprising a sta- tionary sample container rack as defined herein above and further component. The sys-tem may, for example comprise a stationary sample container rack and one or more mobile sample container racks as defined herein.

[0079] Alternatively, the system may comprise a stationary sample container rack and a pneumatic tube system. In this embodiment, the pneumatic tube system may be connected to the rack via suitable adaptors as described herein.

[0080] In a further embodiment the system may comprise a stationary sample container s rack and a remote receiving station. The term "remote receiving station" as used herein, relates to a network based database server, which is connected to the stationary sample container rack and/or a mobile sample container rack. The present invention accordingly envisages an independent remote receiving station, which is connected in a wireless communication fashion with one or more component(s) of the stationary sample con-tainer rack concept of the present invention. Further, the remote receiving station may be connected to further components which may contribute to the organization and/or management of the sample management, transport and/or subsequent sample analysis. For example, the remote receiving station may be connected to the mobile sample container rack, to an analyzer device, which is designed to further process the sample is and/or perform diagnostic, biochemical or chemical assays, to a device directly associ- ated with a patient, e.g. a handheld device such as a smartphone or a tablet PC, or a wearable, to a further device or component, which may, for example be located at an hospital or an independent service provider, and/or to any type of end user, which is interested in the data, e.g. by an independent app or program, carried out on a com- puter, or to a handheld device such as a smartphone, e.g. comprising an App which al-lows to monitor the transport of the sample containers/sample container rack. The connection between these components and the remote receiving station may be unidirectional, e.g. from the components to the receiving station or from the receiving station to the component, or it may be bi-or multidirectional, allowing for a complete exchange of information, advantageously filtered according to necessities and requirements, e.g. predefined information hierarchies or priority lists, between all integrated elements. It is preferred that the remote receiving station works as a cloud-or network-based server. In a corresponding architecture, one component may be considered as a client, and a different component may be considered as a server. Each element may further comprise multiple systems, subsystems or components. Typically, a cloud server is an infrastructure as a service based, platform-based or infrastructure-based cloud service model. A cloud server may either be a logical cloud server or a physical cloud server, wherein the logical cloud server may be provided through server virtualization and the physical cloud server may be seen as classical server, which is accessed through internet or remote access options. The physical server may further be distributed logically into two or more logical servers. Corresponding services are offered by several companies, including Amazon, Google, IBM and Microsoft. In a specific aspect, the remote receiving station is designed to receive in a wireless and/or real-time communication fashion information io of a stationary sample container rack or of a sample container, preferably as defined herein above regarding one or more of the following: temperature, humidity, vibrations and/or exerted centrifugal forces, GPS-tracks, light intensity on the sample, image captured of the sample container or the stationary or mobile sample rack, filling volume of the sample container, type of the sample container, potential hemolysis, icterus or li-paemia in a sample in a sample container, time parameters of the sample container rack's use and sample quality parameters of each of the sample containers, e.g. as described herein in the context of the sample container rack. This information may be accumulated or stored in the server, e.g. in a suitable database format. The information may, in further embodiments, be used for a decision making process and/or organiza-tional decisions as to the fate and future of a specific sample, and/or as to potential further activities associated with a patient, e.g. additional sample taking etc. The information may further be used for quality management evaluation, e.g. by checking KPIs, e.g. with the assistance of machine learning or Al modules or algorithms as described herein.

[0081] In yet another embodiment the system may comprise a stationary sample con-tainer rack and a sample analyser, e.g. as defined herein. This system may, for example, be present in a hospital where the stationary sample container rack and the analyser may be used in vicinity to each other. A corresponding system may further comprise a mobile sample container rack and/or a pneumatic tube system.

[0082] In further embodiments, additional system types comprising a stationary sample container rack and two or more of the above mentioned components are envisaged. [0083] In a further aspect the present invention relates to a method for pre-analytically determining one or more parameter(s) of a sample provided in a sample container and/or of a sample container. This determination is envisaged to be performed in the stationary sample container rack as defined herein.

[0084] The parameters to be determined are one or more of the following: identity of the sample and/or sample container; type of sample container, preferably identifiable via a color code and/or shape; io loading status of the sample container(s); - volume of the sample container(s), preferably identifiable by shape; filling volume of the sample container(s); - sample number; - specific position of the sample container(s) in the stationary sample container rack; -temperature of the sample(s) and/or sample container(s) and/or stationary sample container rack, preferably at the time point of sample container placement in the stationary sample container rack; - sample temperature at one or more time-points after sample container placement; - humidity of the sample(s) and/or sample container(s); -time parameters of the stationary sample container rack's use; - time parameters of individual samples after sample container placement: - index of the sample(s) relating to hemolysis, icterus or lipaemia; - centrifugation status of the sample(s); - presence of a liquid and/or solid phase and/or of a separating gel layer in the sample(s); - ratio of liquid and solid phases in the sample(s); - sorting status of the sample container(s); - storage status of the sample container(s); - presence/absence of caps on the sample container(s); - aliquoting status of the sample(s); and - one or more quality parameter(s) ofthe sample(s), preferably pH, ionic concentration, and presence of apoptotic, inflammatory or infectious indicators.

[0085] In a specific embodiment, the checking may comprise any suitable sub-group of the mentioned parameters, e.g. 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 etc. of the parameters mentioned above. In a further preferred embodiment, the checking may comprise one, more or all of the following sub-group of parameters: identity of the sample and/or sample container; type of sample container, preferably identifiable via a color code and/or shape; volume of sample container, preferably identifiable by shape; filling volume of the sample container(s); and temperature of the sample and/or sample container and/or sample container rack, preferably at the time point of sample container placement in the stationary is sample container rack.

[0086] In a further preferred embodiment, the checking may additionally or alternatively comprise one, more or all of the following sub-group of parameters: - sample number; specific position of the sample container(s) in the stationary sample container rack; humidity of the sample(s) and/or sample container; time parameters of the stationary sample container rack's use; index of the sample(s) relating to hemolysis, icterus or lipaemia; centrifugation status of the sample(s); presence of a liquid and/or solid phase and/or of a separating gel layer in the sample(s); ratio of liquid and solid phases in the sample(s); loading status of the sample container(s); sorting status of the sample container(s); storage status of the sample container(s); aliquoting status of the sample(s); and one or more quality parameter(s) of the sample, preferably pH, ionic s concentration, and presence of a poptotic, inflammatory or infectious indicators [0087] The term "identity of the sample and/or sample container" as used herein relates to information concerning the sample itself, e.g. its nature or form as blood, urine, feces, serum, as well as the sample container. This identity may be connected to information on the patient, the sample pre-treatment or processing, the time of the sampling, io planned assays etc. [0088] The "type of the sample container" may be checked with respect to predetermined types, e.g. in a color coded manner. For example, sample containers may differ with respect to the subsequent analysis planned, the identity or form of the sample, e.g. whether it is a blood, a serum, a plasma, a urine, a feces sample etc., or the amount of is sample used, the transport conditions etc. The information on the type of sample con-tainers may be compared with information on the sample container present at the analyser location or in a remote server database. The color coded manner may essentially be a coding of the cap color of the sample container. The "cap color of the sample container" is hence a parameter which may be linked to the sample type, e.g. blood, serum, urine etc. The parameter may, in alternative embodiments, also differ with respect to the subsequent analyses planned or the amount of sample used, the transport conditions etc. The information on the cap color of sample containers may be compared with information on the cap color present at the analyzer location or in a remote server database [0089] The term "loading status of the sample container(s)" refer to the loading or entry of sample containers into the stationary sample container rack. This loading may be finished, partially finished or starting. The status may further reflect the number of sample containers entered into the rack for processing.

[0090] The "volume of sample container" is meant to constitute a parameter which is connected to the sample type and also the subsequent analysis planned. The checking may, for example, be performed via an identification of the shape of the sample container, e.g. with specific shapes being associated with certain volumes.

[0091] The ''filling volume" of one or more sample container(s) in the rack may be de-termined and compared with a predetermined range of filling volumes. The filling volume may be made dependent on the intended subsequent analysis of the sample, the number of different analyses planned for a patient, minimal volume requirements for certain analyses etc. [0092] A "sample number" may be provided, e.g. in the form of a barcode, QR code or electronically via RFI D. Such information may accordingly be checked.

[0093] The "specific position in the sample container" is a parameter which may be linked to predefined positions for certain sample types or for determining the arbitrary position in the sample container where the sample container has been inserted. Also envisaged is a simple registration of a sample after it has been placed at an arbitrary position in the sample container rack.

[0094] The term "index of the sample relating to hemolysis, icterus or lipaemia" means that the color of the sample container content is determined since it can potentially indicate hemolysis, icterus or lipaemia. Accordingly, a potential disease state of a patient and/or a corresponding usage modification of the sample from said patient can be de- tected via the color of the sample in the sample container. This color change is also known as serum index or HIL-index. The term "hemolysis" as mentioned herein refers to the rupture of erythrocytes resulting in the release of its intracellular components, e.g. haemoglobin, and flooding the plasma or serum with potassium and other internal com-ponents. The hemolysis of samples may be detected according to a color change of the serum or plasma sample, e.g. from pink to red, de-pending on the number of cells that have lysed. The term "icterus" as used herein means jaundice or hyperbilirubenemia, which are typically associated with the presence of high levels of bilirubin due to increased bilirubin production or inappropriate extraction, e.g. in diseases such as haemolytic anemia, liver diseases, biliary tract obstruction, etc. Icteric serum or plasma may be detected via changes in sample color from normal straw color to dark or bright yellow.

s The term "lipaemia" as used herein refers to the presence of excess lipids or fats due to increased concentration of triglyceride-rich lipoprotein in blood resulting in the cloudy/turbid appearance of serum or plasma.

[0095] The "centrifugal status of the sample container" as used herein relates to the determination of a previous centrifugation step performed with the sample or sample lo container in case of liquid samples, e.g. blood samples. This can be detected by as-sessing the presence of different phases in the liquid sample or the presence of a precipitate in the sample container. For example, the presence of liquid or solid phases may provide information on a previous centrifugation or the form and details of a centrifugation. Similarly, a ratio of liquid and solid phases may be determined which also allows is to determine whether a centrifugation has been performed and in which form and length. Should there be, for example, no phases in the sample container detectable, this would indicate that no centrifugation has been performed or that the centrifugation was not performed in a suitable length.

[0096] The term "sorting status of the sample container(s)" as used herein relates to the position and associated destination of a sample container within the stationary sample container rack. The sorting may accordingly be finished, partially finished or starting. The status may further reflect the number of mobile sample containers attached to the stationary sample container rack.

[0097] The term "storage status of the sample container(s)" as used herein relates to the place and storage condition of a sample container within the stationary sample con-tainer rack. The storage may accordingly take place under different conditions, whose setting may further be checked.

[0098] The term "aliquoting status of the sample(s)" as used herein relates to the number of aliquots derived from a sample in a sample container, as well as their place and destination. The aliquoting status may further be linked to analyses to be performed. Accordingly obtained parameter information may be compared with analytical orders.

[0099] Also additional quality parameters may be checked. These may include pH, ionic concentration and the presence of apoptotic, inflammatory or infectious indicators. The checking of such parameters may, for example, for performed in a point of care unit.

[0100] The mentioned parameters may preferably be measured with devices or sensors as described herein. The checking may, in further embodiments, comprise a registering io and storing of correspondingly obtained information, as well as a comparison with pre-defined target values or corridors of values. For example, any parameter measured or monitored may be compared with a database entry as to a desired or undesired value of said parameter, or a corridor of desired values with corresponding limits. In case an undesired value is measured or the parameter leaves the predefined corridor, an alert is is produced and/or a decision as to the fate and future of the sample which is associated with the measured value is started.

[0101] It is preferred that said checking is performed in an automatic manner. One option is to use contactless communication between the sample container and the stationary sample container rack or to automatize reading, image capture and recognition ac-tivities. For example, the employment of an RFID (radio frequency identification) unit, a Bluetooth interaction, a GSM, LTE or G5 unit, a LPWAN unit, a LoRaWAN unit, or a WiFi unit, a barcode reading or image capturing is envisaged. The checking may accordingly be started automatically once a sample container is placed in a slot, e.g. a specifically allocated slot or a arbitrarily selected slot of the sample container rack, or if a sensor as mentioned captures an image due to a newly placed sample container or if a contact becomes possible, e.g. via Bluetooth because the sample container is in the vicinity of the registration unit.

[0102] The term "automated manner via contactless communication" generally relates to an electronic or computerized element which either actively sends out a signal to a base station, or works passively and may react to a signal generated by a base station. In both scenarios, the signal may be transmitted without direct physical contact be-tween the sample container and a base station, e.g. via radio waves. The contactless communication may, for example, be based on RFID (radio-frequency identification) technology.

[0103] It is particularly preferred that the pre-analytical determining is performed in at least one sample container slot within the stationary sample container rack, which is io configured to check one or more parameter(s) of a sample container. This checking may, in a preferred embodiment, be performed in a master checkin slot as defined herein. [0104] In another preferred embodiment, the parameter value is provided in a digitalized form. Accordingly, data, e.g. derivable from captured images etc. may be digitalized during the checking procedure. This activity may be performed in a suitable micropro-cessor in the rack or after the information has been provided to a receiving station as described or the information has been provided to a mobile device, in a LIS or in a sample analyzer unit as described herein.

[0105] In an additional aspect, the present invention relates to a computer implemented method for pre-analytically determining one or more parameter(s) of a sample provided in a sample container and/or of a sample container, wherein said sample con-tainer is present in a stationary sample container rack as defined herein, wherein said parameters comprise: identity of the sample and/or sample container; type of sample container, preferably identifiable via a color code and/or shape; -loading status of the sample container(s); - volume of the sample container(s), preferably identifiable by shape; filling volume of the sample container(s); - sample number; - specific position of the sample container(s) in the stationary sample container rack; - temperature of the sample(s) and/or sample container(s) and/or stationary sample container rack, preferably at the time point of sample container placement in the stationary sample container rack; -sample temperature at one or more time-points after sample container placement; - humidity of the sample(s) and/or sample container(s); time parameters of the stationary sample container rack's use; time parameters of individual samples after sample container placement: - index of the sample(s) relating to hemolysis, icterus or lipaemia; io -centrifugation status of the sample(s); - presence of a liquid and/or solid phase and/or of a separating gel layer in the sample(s); - ratio of liquid and solid phases in the sample(s); - sorting status of the sample container(s); -storage status of the sample container(s); - presence/absence of caps on the sample container(s); - a liq uoting status of the sample(s); and - one or more quality parameter(s) of the sample(s), preferably pH, ionic concentration, and presence of apoptotic, inflammatory or infectious indicators.

[0106] In yet another aspect, the present invention relates to a computer program com-prising instructions which, when the program is executed by a computer, cause the computer to carry out the method as defined herein above.

[0107] Any of the software components or computer programs or functions described herein may be implemented as software code to be executed by a processor using any suitable computer language such as, for example, Java, Python, Javascript, VB.Net, C++, 04, C, Swift, Rust Objective-C, Ruby, PHP, or Perl using, for example, conventional or object-oriented techniques. The software code may be stored as a series of instructions or commands on a computer readable medium for storage and/or transmission, suitable media include random access memory (RAM), a read only memory (ROM), a magnetic medium such as a hard-drive, or an optical medium such as a compact disk (CD) or DVD (digital versatile disk), flash memory, and the like. The computer readable medium may be any combination of such storage or transmission devices. Such pro- grams may also be encoded and transmitted using carrier signals adapted for transmis-sion via wired, optical, and/or wireless networks conforming to a variety of protocols, including the Internet. As such, a computer readable medium according to the present invention may be created using a data signal encoded with such programs. Computer readable media encoded with the program code may be packaged with a compatible io device or provided separately from other devices (e.g., via Internet download). Any such computer readable medium may reside on or within a single computer program product (e.g. a hard drive, a CD, or an entire computer system), and may be present on or within different computer program products within a system or network. A computer system may include a monitor, printer, or other suitable display for providing any of the results mentioned herein to a user. Particularly preferred is the provision of a smartphone, ta-ble or mobile device app, or of a corresponding desktop computer app or program, which allows for a user interphase communication and the entry of information. Also particularly preferred is the provision of suitable software or computer programs capable of controlling wearables and of transmitting data between wearables and receiving devices. Further particularly preferred is the provision of suitable server software, e.g. cloud based servers, which implements decision making on the basis of received information, the organization and management of data from a stationary sample rack or from wearable(s) and the presentation of information on one or more different interface(s) such as a web-interface or a tablet or smartphone app.

[0108] Any of the parameter determining methods described herein may be totally or partially performed with a computer system including one or more processor(s), which can be configured to perform the steps. Accordingly, some of the present embodiments are directed to computer systems configured to perform the steps of any of the moni-toring methods described herein, potentially with different components performing respective steps or a respective group of steps. Corresponding steps of methods may further be performed at a same time or in a different order. Additionally, portions of these steps may be used with portions of other steps from other methods. Also, all or portions s of a step may be optional. Additionally, any of the steps of any of the methods can be performed with modules, circuits, or other means for performing these steps. It is particularly preferred that at least some of the methods are performed on a cloud-based computer system [0109] In Figure 1 an embodiment of the stationary sample container rack according to io the present invention is shown. The rack comprises one or more of the following com- ponents or units: A display output and input 1. This element provides feedback, is linked to orders or order input. A patient or operator verification test is also envisaged. Furthermore, the rack may comprise a sample container loader 2. Also included may be sample container registration unit or sample capture module 3 for sample imaging, bar-is code reading, cap color reading, filling volume checking, determination of serum index etc. This unit may be implemented, for example, as camera or spectroscope. The rack additionally comprises a data processing unit 4, which is configured for image analysis, calculating the spinning status, hemolysis analysis, blood sedimentation checking, or Artificial Intelligence (AD-based pattern recognition etc. This Al component with the data processing unit, e.g. in form of a software product or algorithm, which is executed therein, may preferably be configured to evaluate received data with respect to predetermined or trained pattern, which can be used for quality management or feedback purposes. Furthermore, the rack comprises a sample mixer 5. The rack also envisages a spinning or centrifugation element 6. Subsequently, a sample sorter 7 may be used. The samples may be stored in a sample storage unit 8 after processing, e.g. for a subsequent transport step or for accumulating additional similar samples etc. Also envisaged is a storage for longer time, e.g. as reference sample, in suitable compartments such as refrigerator units or freezer units. The rack may also comprise a sample container reservoir 9. In this unit empty sample container may be stored or be selected for further processing steps, e.g. in an automated manner. The rack may additionally comprise a label printer 10, which may preferably be used for automated label printing. Additionally, a sample container labelling unit 11 may be present. This unit typically makes use of the printed labels of unit 10 and connects the labels with the sample containers, e.g. with a rolling mechanics. Furthermore, the rack may comprise a storage unit 12, which is designed to comprise consumables, test reagents, buffers, water etc. which are necessary for the performance of the operations within the rack. This unit may have a heating and/or cooling device which actively regulates the temperature in the compartment.

[0110] In Figure 2 a further embodiment of the stationary sample container rack accord-ing to the present invention is shown. The rack may comprises in addition to one or more of the components shown in Figure 1 one or more of the following components or units: A sensor 20. This element is configured to monitor one or more environmental parameters such as temperature, humidity etc. The rack may further comprise a microprocessor 21 for data processing. Also included may a point of care device 22 for testing of the samples. The rack may further comprise an acoustic input and output unit 23, which is configured to provide speech control. This unit may be linked to order or entry control or inputting elements, e.g. in a display, or to patient or operator verification procedures. Furthermore, the rack may comprise a communication module 24, which is configured for data transmission. Also envisaged is a unit configured for linkage to a patient health record or patient file 25 via data transmission. The rack further comprises a unit configured for linkage to a patient's wearable 26 via data transmission. This unit may register the health status of a patient. The rack may additionally comprise a unit configured for linkage to a LIS/KIS/CP0E/KAS system 27 via data transmission. Also envisaged is a unit configured for linkage to an analyzer 28 via data transmission, e.g. at a remote a nalytics or test site. A further component may be present which is configured for recognition of patient biometrics 29. This unit may be used for patient verification, e.g. via fingerprints, iris scan etc. The rack may additionally comprise a card reader 30, which may be used for patient or operator verification. Also envisaged is a transport unit 31 for the sample containers. This element may allow image acquisition during the transport process. The images may subsequently be analyzed with respect to hemolysis, lipaemia etc. Furthermore, the rack may comprise a decapper unit 32, an aliquoting unit 33, a de-sealer unit 34, and a physical link to an analyzer platform 35. Further included may be smartphone or App interface 36, which is configured to control the rack or to show information to the operator or patient etc. The rack may further comprise a link and/or an adaptor to a pneumatic tube system 38, which may be automated for loading and sending pneumatic tube system containers. In addition, the rack may comprise a balance 38, a cooling and/or heating unit 39, a centrifugation-free sample separation unit 40, as well as an io exhausting unit 41, which is configured to remove residual air from sample containers.

[0111] The figures and drawings provided herein are intended for illustrative purposes. It is thus understood that the figures and drawings are not to be construed as limiting. The skilled person in the art will clearly be able to envisage further modifications of the is principles laid out herein.

Claims

CLAIMS1. A stationary sample container rack designed to receive one or more sample container(s) as a base station, wherein said stationary sample container rack is configured to process the sample and/or manage the sample container(s), wherein said stationary sample container rack comprises at least three or more of the following: an interactive display for input and/or output operations, a sample container loader, a sample container registration unit, a sample mixer unit, a centrifugation unit, a sample sorting unit and a sample stor-io age unit, wherein said stationary sample container rack is connectable to one or more mobile sample container rack(s) for transport.
2. The stationary sample container rack of claim 1, wherein said sample container registration unit is an optical detection unit, preferably a camera or a is spectroscope.
3. The stationary sample container rack of claim 1 or 2, wherein said stationary and said mobile sample container rack are capable of direct communication with each other; or of contactless communication with each other and/or with a remote receiving station, preferably comprising one or more unit(s) for contactless communication, configured for data transmission such as an RFID (radio frequency identification) unit, an NFC (near field communication) unit, a GSM, LTE or G5 unit, a LPWAN unit, a LoRaWAN unit, a Bluetooth unit or a WiFi unit.
4. The stationary sample container rack of anyone of claims 1 to 3, wherein said interactive display for input and/or output operations comprises an optical and/or acoustic intercommunication module and is configured to provide an interface and/or a functionality for one or more of the following tasks: verification of patient identity, preferably via measuring or receiving biometric data directly from the patient, or via a data carrier such as a smart cart, a mobile device or a wearable; acoustic operator guidance and/or receiving of acoustic commands; verification of operator identity, preferably via measuring or receiving biometric data directly from the patient, or via a data carrier such as a smart cart, a mobile device or a wearable; inputting of analytic orders or assignments; fetching of electronic health records; outputting of performed steps within the stationary sample container rack; outputting of steps to be performed outside the stationary sample container rack; confirmation of performed steps within the stationary sample container rack and/or feedback on said steps or lack of said steps; and confirmation of steps to be performed outside the stationary sample container rack and/or feedback on said steps or lack of said steps.
5. The stationary sample container rack of any one of claims 1 to 4, additionally comprising one or more of the following: a sample container reservoir, a label printer unit, a sample container labelling unit, an incubation unit and a storage unit.
6. The stationary sample container rack of anyone of claims 1 to 5, wherein said stationary sample container rack is connectable to a pneumatic tube system, preferably comprising an adaptor for a pneumatic tube system, wherein said adaptor and said pneumatic tube system are preferably configured for automatic loading and/or sending.
7. The stationary sample container rack of any one of claims 1 to 6, additionally comprising one or more of the following: (i) a sensor device for monitoring, preferably for determining the temperature of the sample container and/or of the stationary sample container rack and/or the environmental temperature and/or of the mobile sample con-tainer rack, preferably per individual sample container slot within the stationary sample container rack, a device for determining the humidity of the stationary sample container rack and/or of the mobile sample container rack, a light sensor and/or device capable of detecting the opening or closing of the io stationary sample container rack and/or of the mobile sample container rack; (ii) a machine learning and data processing unit; (iii) a point of care testing unit; (iv) an acoustic input and/or output module; (v) a mechanic sample container displacement and manipulation unit, de- signed to move or reposition a sample container within the rack, or a con-nected component, preferably a mobile sample container rack and/or a pneumatic tube system, and/or to modify or change the shape and/or comprised volume of a sample container, preferably to press out residual air from a sample container; (vi) a unit for linkage to a patient file or patient order, configured for data transmission; (vii) a unit for linkage to a patient wearable, configured for data transmission; (viii) a unit for linkage to a health information system, LIS/KIS/CPOE or KAS system, configured for data transmission; (ix) a unit for linkage to an analyzer, configured for data transmission; (x) a unit for patient biometrics recognition, preferably of a patient's fingerprints or iris; (xi) a card reader; (xii) a sample container transportation unit; (xiii) a balance, configured to determine individual sample container weights; (xiv) a cooling and/or heating unit; (xv) a sample separation unit, preferably configured to separate liquid and solid components in a sample container in a centrifugation-free manner, more preferably configured to separate liquid and solid components in a sample container by sedimentation or ultrasonication.
8. The stationary sample container rack of claim 7, wherein said machine learn-ing and data processing unit is configured to perform one or more of the following tasks: automatized evaluation of sample registration data and/or measured parameters, preferably of image data; autonomous calculation of key performance indicators (KPIs) or quality indicators obtained during one or more pre-analytic activities within or outside the stationary sample container rack; autonomous generation of system or user feedback on the basis of calculated KPIs; autonomous identification and marking or erroneous or defect samples and/or sample containers; and comparison of measured data or parameters with a data or parameters derived from a database, preferably an internal database.
9. The stationary sample container rack of any one of claims 1 to 8, additionally comprising one or more of the following: (i) a de-recapper unit; (ii) an aliquoting unit; (iii) a de-sealer unit; (iv) a physical link to an analyzer platform; (vi) a smartphone, internet, Intranet or app interface.
10. A system comprising a stationary sa mple container rack as defined in any one of claims 1 to 9 and one or more of the following: (i) one or more mobile sample container racks; (ii) a pneumatic tube system; (iii) a remote receiving station; and (iv) a sample analyzer.
11. The stationary sample container rack of any one of claims 6 to 9, or the sys- tem of claim 10, wherein said pneumatic tube system comprises a carrier component for transport of one or more sample containers, wherein said carrier component comprises one or more sensors designed to register tem- perature and/or acceleration data and/or time conditions of the sample con-tainer.
12. The stationary sample container rack of any one of claims 2 to 9, or the sys-tem of claim 10 or 11, wherein said mobile sample container rack(s) comprise two or more sections configured to receive sample containers of different shape, different content, different destinations, or different pre-analytic status.
13. The stationary sample container rack of any one of claims 2 to 9 or 12, or the system of any one of claims 10 to 12, wherein said mobile sample container rack comprises one or more of the following: one or more unit(s) for con-tactless communication with a base station, an RFID (radio frequency identification) unit, preferably an NFC (near field communication) unit, or a Blue-tooth unit or an ID-chip unit, a barcode, a barcode reader, an RFID reader, a Bluetooth device, a digital memory, a data processing unit, a device for de-termining the temperature of the sample container and/or of the sample container rack, preferably per individual sample container slot within the sample container rack, a device for determining the humidity of the sample container rack, optionally a device capable of determining vibrations and centrifugal forces exerted on the rack, a geographic tracking device, preferably a GPS device and/ or a GSM triangulation unit, a device capable of determining time parameters of the sample container rack's use, a light sensor and/or device capable of detecting the opening or closing of the sample con-tainer rack, an acoustic and/or optical alarm module, an electric power source, preferably a battery, and a communication module allowing for wireless and/or real-time communication with a remote receiving station.
14. A method for pre-analytically determining one or more parameter(s) of a io sample provided in a sample container and/or of a sample container, wherein said determination is performed in the stationary sample container rack as defined in any one of claims 1 to 9 or 11 to 13.
15. The method of claim 14, wherein said parameters comprise one or more se-lected from: identity of the sample and/or sample container; type of sample container, preferably identifiable via a color code and/or shape; loading status of the sample container(s); -volume of the sample container(s), preferably identifiable by shape; filling volume of the sample container(s); - sample number; specific position of the sample container(s) in the stationary sample container rack; -temperature of the sample(s) and/or sample container(s) and/or stationary sample container rack, preferably at the time point of sample container placement in the stationary sample container rack; - sample temperature at one or more timepoints after sample container placement; - humidity of the sample(s) and/or sample container(s); time parameters of the stationary sample container rack's use; - time parameters of individual samples after sample container placement: - index of the sample(s) relating to hemolysis, icterus or lipaemia; -centrifugation status of the sample(s); - presence of a liquid and/or solid phase and/or of a separating gel layer in the sample(s); - ratio of liquid and solid phases in the sample(s); - sorting status of the sample container(s); -storage status of the sample container(s); - presence/absence of caps on the sample container(s); aliquoting status of the sample(s); and - one or more quality parameter(s) of the sample(s), preferably pH, ionic concentration, and presence of apoptotic, inflammatory or infectious indicators.
16. The method of claim 14 or 15, wherein said pre-analytical determining is initiated in an automatic manner via contactless communication between the sample container and the sample container rack by RFID (radio frequency identification), Bluetooth interaction, a GSM, LTE or G5 unit, a LPWAN unit, a LoRaWAN unit, or a WiFi unit, barcode reading or image capture, or wherein said checking is started after a stimulus is triggered (i) by a sample container passing a mechanic or optical barrier, or (ii) by an operator, preferably via manual activation of a start button.
17. The method of any one of claims 14 to 16, wherein said pre-analytical determining is performed in at least one sample container slot within the stationary sample container rack and/ or the mobile sample container rack, which is configured to check one or more parameter(s) of a sample container.
18. The method of any one of claims 14 to 17, wherein the parameter value is provided in a digitalized form.