EP3673450A1

EP3673450A1 - Smart methods for sample checking, surveillance and management

Info

Publication number: EP3673450A1
Application number: EP19704630.3A
Authority: EP
Inventors: designation of the inventor has not yet been filed The
Original assignee: Smart4diagnostics GmbH
Current assignee: Smart4diagnostics GmbH
Priority date: 2018-02-15
Filing date: 2019-02-15
Publication date: 2020-07-01
Also published as: EP3673449A1; WO2019158732A1; EP3673451A1; WO2019158729A1; WO2019158733A1

Abstract

The present invention relates to a method for checking one or more parameter(s) of a sample container between the step of filling the sample in the container at point of sample collection and the initiation of the transport of said sample container in a sample container rack, wherein said sample container is configured to be placed in a sample container rack designed to receive one or more sample container(s) as a base station. Also envisaged is a method for recording a temperature parameter history log of an individual sample container in a sample container rack and a computer implemented method for checking or assessing one or more parameter(s) of a sample container. The methods inter alia allow for a real-time tracking during placement and transport of samples and provide sample management options between placement of sample container into sample container rack and sample analyses.

Description

Smart methods for sample checking, surveillance and management

FIELD OF THE INVENTION

[0001] The present invention relates to a method forchecking one or more parameter(s) of a sample container between the step of filling the sample in the container and the initiation of the transport of said sample container in a sample container rack, wherein said sample container is configured to be placed in a sample container rack designed to receive one or more sample container(s) as a base station and to receive to a remote receiving station designed to receive in a wireless and/or real-time communication fash ion information of a sample container rack or of a sample container. Also envisaged is a method for recording a temperature parameter history log of an individual sample con- tainer in a sample container rack and a computer implemented method for checking or assessing one or more parameter(s) of a sample container. The methods inter alia allow for a real-time tracking during placement and transport of samples and provide sample management options before sample analyses.

BACKGROUND OF THE INVENTION [0002] Digitization and smart technologies enable pharmaceutical, technical, and diag nostic companies to perform quantum leaps in research and development. Patients will benefit in the near future from tailor-made and individualized treatment strategies for their disease. Due to more precise analysis and innovations in the field of precision med- icine more sensitive tests and specific differential diagnoses become possible. In partic ular, blood-based biomarker analyzes are gaining in importance. As a result, significantly more blood samples will be collected, sent and analyzed using high-resolution diagnostic assays. Forthe examination of hematological samples, there are already first innovative, miniaturized and digitized in vitro diagnostic solution packages. However, for controlled shipping, tracking and proof of the integrity of the samples during the pre-analytical phase or the transport and for a digital communication between sample and analyzer a smart next-generation data approach is missing entirely.

[0003] Global companies need a large number of individual samples for clinical trials, which come from different countries due to rare or only locally occurring indications. In Germany alone blood is transported to the value of approx. 4.5 billion EUR - the world's blood transport costs around 40 - 60 billion EUR p.a. These blood samples serve the development of new products whose value (or their loss at the failure of the develop ment) changes with a factor of 10 (based on the transport value). Therefore, blood sam- pies and other samples are by far the most important raw material for the diagnostics industry. Their quality is crucial for the successful placing of new products on the market, whereby their handling has been neglected so far.

[0004] The transport of blood and other body fluids must be carried out under con trolled temperature conditions of up to -80 ° C and a guaranteed cold chain. To date, this is done in most cases "offline and analog" by adding temperature monitoring means directly in the transport container, for example with the aid of so-called temperature- active strips for simple detection, or electronic temperature data loggers for recording and subsequently reading out the data. However, these methods are highly susceptible to disturbances and fraud, require additional expenses and cannot be tracked by third parties such as customers or users in real-time. Once a sample has left the intended temperature corridor and this is not documented, uncorrectable and unpredictable ef fects on the quality or composition of the sample are produced. This can endanger the entire result of an analysis and, in the worst case, lead to a falsification of the diagnostic results. A truly comprehensive, digitally comprehensible and verifiable solution to this problem, which sets global standards, is not yet available.

[0005] Annually around 8 billion blood samples are analyzed globally. For example, 285 million blood draws and 690 million blood samples collections were reported in Ger- many in 2018. Blood draws are typically taking place in outpatient or stationary settings Blood draws are performed by healthcare practitioners e.g. clinicians or nurses and blood samples have to be sent to the medical lab for analyses on the same day. Transport is normally performed in-house by pneumatic tube system or by walking. For settled doctors and samples to be analyzed by laboratory service providers, samples are normally be picked up once a day by courier service and samples often travel a few hun dred kilometers to the laboratory. At arrival in the laboratory, samples are registered and processed at sample entry. Between 6 - 10 % of all samples are processed manually after arrival at sample entry, which results in 25 % costs of the lab operational staff for manual trouble shooting efforts. Most of these samples need manual preparation be- cause they were negatively affected by pre-analytical errors such as wrong tube, wrong label, mislabeling, low filling volume, hemolysis, non-conforming mapping of lab orders and sample barcodes, missing or redundant sample or lab orders or the like which com promises the sample quality before its arrival in the laboratory and leads to additional manual labor at sample entry for manual sample quality assurance. The total cost for processing one sample manually due to any of these errors is twice the cost of auto mated processing. Furthermore, an additional 5 % of all goods and consumables must be spent to achieve reimbursable results due to repetitive measurements.

[0006] Detecting and reducing these pre-analytical errors automatically at the point of blood collection could potentially improve medical quality and cut short the spending of an average laboratory by 10 %, through the reduction of manual labour costs and savings of consumables or materials, e.g. test reagents for unnecessary analyses. By improving medical quality and reducing costs for inappropriate patient treatment, up to 400 mil lion Euros can be saved annually in the German healthcare system, 2.000 million Euro all over Europe in a highly competitive market, in which automation and efficiency are key for further profits and key driver of innovation. The additional value of increased diagnostic quality, improved patient safety, easier compliance with regulatory guide lines (e.g. ISO 15189) and competitive advantages are an additional value. Studies have shown that for every Euro that is saved through better quality in pre-analytics, three Euros are saved for healthcare-systems because of less manual troubleshooting, less medical errors and lower treatment costs.

[0007] There is thus a need for an efficient approach to control shipping, tracking and proof of the integrity of biological or medicinal samples during the pre-analytical phase and the transport and for a digital communication between the sample and assisting devices, as well as corresponding, digital communication-based analyzer technology.

OBJECTS AND SUMMARY OF THE INVENTION

[0008] The present invention addresses these needs and provides in one aspect a method for checking one or more parameter(s) of a sample container between the step of filling the sample in the container and the initiation of the transport of said sample container in a sample container rack, wherein said sample container is configured to be placed in a sample container rack designed to receive one or more sample container(s) as a base station. [0009] In a preferred embodiment, 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;

volume of sample container, preferably identifiable by shape;

- filling volume of the sample container;

sample number;

specific position of the sample container in the sample container rack; temperature of the sample and/or sample container and/or sample container rack, preferably at the time point of sample container placement in the sample container rack;

humidity of the sample and/or sample container;

- time parameters of the sample container rack's use;

index of the sample relating to hemolysis, icterus or lipaemia;

centrifugation status of the sample;

presence of liquid and/or solid phase in the sample;

ratio of liquid and solid phases in the sample;

- content of order form attached to the sample container rack; and

one or more quality parameter(s) of the sample, preferably pH, ionic concentration, and presence of apoptotic, inflammatory or infectious indicators.

[0010] In a further preferred embodiment, said checking is performed in an automatic manner via contactless communication between the sample container and the sample container rack by RFID (radio frequency identification), Bluetooth interaction, 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. In a particularly preferred embodiment, said checking is performed in an automatic man ner via manual activation of a start button. [0011] In a particularly preferred embodiment, said checking is performed in at least one sample container slot within the sample container rack, which is configured to check one or more parameter(s) of a sample container.

[0012] In a further preferred embodiment, the parameter value is provided in a digital ized form. [0013] In another preferred embodiment, the checking of one or more parameter(s) of a sample container between the step of filling the sample in the container and the initi ation of the transport of said sample container in a sample container rack is performed in a sequential order for two or more sample containers. [0014] In a preferred embodiment, said sample container can be placed in any available slot within the sample container rack, or said sample container is placed in a specific, predetermined slot within the sample container rack.

[0015] In yet another preferred embodiment, the specific placing in a predetermined slot is checked as an additional parameter. [0016] In a further preferred embodiment, the placing in a slot which is not identical to the predetermined slot leads to recognition of the occupied slot and a corresponding assignment of the sample container.

[0017] In yet another preferred embodiment, said checking of one or more parameter(s) of a second or further sample container starts after the checking of the previous sample container is finished.

[0018] In a further preferred embodiment, subsequent to each termination of a param eter checking per sample container, a status feedback or an alert feedback is provided to a remote receiving station designed to receive in a wireless and/or real-time commu nication fashion information of a sample container rack, or to a sample analyzer de- signed to receive one or more sample container rack(s), wherein said sample analyzer comprises an RFID reader, an Bluetooth device, an barcode reader, an interface between said reader and an analyzer information technology unit, and a communication module allowing for wireless and/or real-time communication with a remote receiving station, or to a remote laboratory comprising said sample analyser, or to an operator handling the sample container or the system. [0019] In yet another preferred embodiment of the present invention the alert feedback is provided if a checked parameter deviates from a predetermined value.

[0020] In another preferred embodiment a decision unit provided locally in the sample container rack and/or in a cloud-based computer server system, or in LIS, or a mobile device or in a sample analyzer unit provides the alert feedback. It is further preferred that a deviation with respect to the slot position of the sample container within the sample container rack leads to a repositioning of the sample container within the sample container rack, more preferably via an automatic repositioning mechanic such as a ro botic device. [0021] In yet another embodiment, subsequent to each termination of a parameter checking per sample container a subsequent processing step is performed such as cen trifugation of the sample container, attaching a label to the sample container, mixing of the sample container after a predetermined period, discarding a sample or vortexing the sample container. [0022] In another aspect the present invention relates to a method for monitoring one or more parameter(s) of a sample container between the step of filling the sample in the container and the analysis of the sample, wherein said sample container is config ured to be placed in a sample container rack designed to receive one or more sample container(s) as a base station. [0023] The mentioned parameters preferably comprise one or more selected from: identity of the sample and/or sample container;

temperature ofthe sample and/or sample containerand/or sample container rack; humidity of the sample and/or sample container;

time parameters of the sample container rack's use;

- vibrations of the sample and/or sample container; and/or exerted centrifugal forces top the sample and/or sample container;

light intensity on the sample; opening or closing of the sample container rack;

filling volume of the sample container;

potential hemolysis, icterus or lipaemia in the sample container;

geographic tracking information of the sample container; and

- one or more quality parameter(s) of the sample, preferably pH, ionic concentration, and presence of apoptotic, inflammatory or infectious indicators.

[0024] In a specific embodiment, said monitoring is performed during the storage, transport or geographical relocation of the sample container in said sample container rack. [0025] In another preferred embodiment, said sample container rack comprises one or more of the following: an RFID (radio frequency identification) unit, a barcode reader, an RFID reader, a digital memory, a data processing unit, a device for determining the temperature and/or humidity of the sample container and/or of the sample container rack, a device capable of determining vibrations and centrifugal forces exerted on the rack, a geographic tracking device, preferably a GPS device, a device capable determin ing time parameters of the sample container rack's use, a light sensor capable of detect ing the opening or closing of the sample container rack, an acoustic 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. [0026] In further aspect, the invention relates to a method for recording a temperature parameter history log of an individual sample container in a sample container rack, wherein said sample container is configured to be placed in a sample container rack designed to receive one or more sample container(s) as a base station.

[0027] In a preferred embodiment, said temperature parameter history log is used to reconstruct the approximate sample collection time point.

[0028] In a particularly preferred embodiment, the checked, monitored and/or rec orded parameters are transmitted to a remote receiving station designed to receive in a wireless and/or real-time communication fashion information of a sample container rack.

[0029] In a further preferred embodiment, the transmission can be performed once or several times such as after an adjustable period of time or after specific geographical checkpoints have been reached, or after one or more parameter(s) as defined in claim 2 or claim 17 are successfully collected, wherein said transmission is preferably auto matic.

[0030] In a further preferred embodiment, transmitted parameters are recorded in a remote computer sever system. In a particularly preferred embodiment, transmitted parameters are recorded in a in a cloud based computer server system.

[0031] In another preferred embodiment, transmitted parameter values are aggregated and/or assessed. In a particularly preferred embodiment, transmitted parameter values are aggregated and/or assessed in an automatized manner.

[0032] In yet another embodiment, checked or monitored parameter values are deliv- ered to a sample analyzer designed to receive one or more sample container rack(s), wherein said sample analyzer comprises an RFID reader, an interface between said reader and an analyzer information technology unit, and a communication module al lowing for wireless and/or real-time communication with a remote receiving station, or to a remote laboratory comprising said sample analyzer. [0033] In a further embodiment, received parameter values are integrated into the sam ple analyzer system. In a particularly preferred embodiment, received parameter values are integrated into an LIS.

[0034] It is particularly preferred that said parameter value integration is performed via cloud-based server system. [0035] In another preferred embodiment, said integration is performed in an automatic manner or via an ID request.

[0036] In a further preferred embodiment, the received parameters are provided in the form of a dashboard, more preferably per each sample container or per sample con- tainer rack, or are alternatively provided as raw data stream, more preferably to an op erator, or in a further alternative are provided in a filtered and/or assessed form in a signal light format, more preferably to an operator.

[0037] In yet another embodiment, said transmission of parameters is initiated imme diately after the placement of the sample container in the sample container rack, pref- erably before the sample container rack's transport is started.

[0038] In a further preferred embodiment, the fact that parameters have been checked and no deviation from a predetermined value have been detected, is transmitted to a remote receiving station designed to receive in a wireless and/or real-time communica tion fashion information of a sample container rack in the form of a contentless short signal.

[0039] In an additional aspect, the present invention relates to a computer imple mented method for checking one or more parameter(s) of a sample container between the step of filling the sample in the container and the initiation of the transport of said sample container in a sample container rack, wherein said parameters comprise:

- identity of the sample and/or sample container;

type of sample container, preferably identifiable via a color code;

volume of sample container, preferably identifiable by shape;

filling volume of the sample container;

sample number;

- specific position of the sample container in the sample container rack;

temperature of the sample and/or sample container and/or sample container rack, preferably at the time point of sample container placement in the sample container rack;

humidity of the sample and/or sample container;

time parameters of the sample container rack's use;

index of the sample relating to hemolysis, icterus or lipaemia;

- centrifugation status of the sample;

presence of liquid and/or solid phase in the sample;

ratio of liquid and solid phases in the sample;

content of order form attached to the sample container rack; and

[0040] In yet another aspect, the present invention relates to a computer implemented method for monitoring one or more parameter(s) of a sample container between the step of filling a sample in the container between the step of filling a sample in the con tainer and the analysis of the sample, wherein said parameters comprise:

- identity of the sample and/or sample container;

time parameters of the sample container rack's use;

vibrations of the sample and/or sample container; and/or exerted centrifugal forces top the sample and/or sample container;

light intensity on the sample;

opening or closing of the sample container rack;

filling volume of the sample container; and

potential hemolysis, icterus or lipaemia in the sample container. [0041] In a further aspect, the present invention relates to a computer implemented method for assessing the parameters as defined herein above with respect to deviation from a predefined value. [0042] In a preferred embodiment of said computer implemented method for assessing the parameters, each parameter deviation leads to a status feedback or an alert feed back, which is provided to a remote receiving station designed to receive in a wireless and/or real-time communication fashion information of a sample container rack, or to a sample analyzer designed to receive one or more sample container rack(s), wherein said sample analyzer comprises an RFID reader, an Bluetooth device, an barcode reader, an interface between said reader and an analyzer information technology unit, and a communication module allowing for wireless and/or real-time communication with a remote receiving station, or to a remote laboratory comprising said sample analyser, or to an operator handling the sample container or the system.

[0043] In yet another aspect, the invention refers to a data processing device comprising means for carrying out the method as described herein above.

[0044] In a further aspect, the invention relates to a computer program comprising in structions which, when the program is executed by a computer, cause the computer to carry out the method as described herein above.

BRIEF DESCRIPTION OF THE DRAWINGS

[0045] Figure 1 shows the technical progress for clinical sample logistics. [0046] Figure 2 depicts options for reducing the analytical error-rate. [0047] Figure 3 depicts pre-analytical errors during sample logistics.

[0048] Figure 4 shows the clinical sample circle.

[0049] Figure 5 indicates that pre-clinical errors are avoidable.

[0050] Figure 6 depicts analytical conclusions. [0051] Figure 7 provides information on smart analyzers.

[0052] Figure 8 shows clinical sample circles.

[0053] Figure 9 describes how smart analyzers will change working in the lab.

[0054] Figures 10 and 11 depict market access strategies. [0055] Figure 12 provides an overview of the problems connected with conventional sample handling.

[0056] Figures 13 and 14 show an illustration of certain aspects of the smart sample monitoring procedure of the present invention.

[0057] Figure 15 depicts a three step process chain to integrate and evaluate preanalyt- ical.

[0058] Figure 16 provides a costs overview of the smart analyzing approach.

[0059] Figure 17 shows a smart three-step process chain for pre-analytics.

[0060] Figure 18 depicts complete recording of all pre-analytical data.

[0061] Figure 19 compares customer benefits. [0062] Figure 20 depicts a flow chart illustrating the implementation of a method for sample registration and check-in at point of sample collection.

[0063] Figures 21 shows a diagram illustrating a smart container rack.

[0064] Figure 22 represents a diagram illustrating parameters at sample registration and check-in at point of collection. [0065] Figure 23 depicts a diagram illustrating the hardware variants of sample con tainer racks. [0066] Figure 24 shows a close-up of a sample container rack during master check-in.

[0067] Figure 25 depicts the detection of several quality parameters of the sample con tainers.

[0068] Figure 26 represents a sample container rack during check-in with live feedback at collection site.

[0069] Figures 27 and 28 show a chart illustrating the sample supply chain and monitor ing with a smart transport container.

[0070] Figure 29 shows the system architecture.

[0071] Figure 30 depicts a chart illustrating the data flow during sample registration and check-in at point collection.

[0072] Figure 31 shows an LIS workflow.

[0073] Figure 32 shows the data integration LIS.

[0074] Figures 33 depicts a web-based dashboard.

[0075] Figure 34 shows a web-based live dashboard for a smart container rack.

[0076] Figure 35 depicts a web-based live dashboard for a sample container.

[0077] Figure 36 shows system change in diagnostics.

[0078] Figure 37 provides an overview of the number of blood sample container used annually.

[0079] Figure 38 describes the bottleneck of manual labour in medical laboratories. [0080] Figure 39 describes the most relevant bottlenecks in medical laboratories uncov ered by an international survey. [0081] Figure 40 depicts pre-analytical errors during sample handling and logistics. [0082] Figure 41 shows sample checking workflow.

[0083] Figure 42 represents sample registration and feedback loop at point of collection and data transmission.

DETAILED DESCRIPTION OF THE EMBODIMENTS

[0084] Although the present invention will be described with respect to particular em bodiments, this description is not to be construed in a limiting sense.

[0085] Before describing in detail exemplary embodiments of the present invention, definitions important for understanding the present invention are given.

[0086] 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 oth erwise.

[0087] 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 %.

[0088] 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. [0089] 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.

[0090] It is to be understood that this invention is not limited to the particular method ology, protocols, reagents etc. described herein as these may vary. It is also to be under stood that the terminology used herein is for the purpose of describing particular em bodiments 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 sci entific terms used herein have the same meanings as commonly understood by one of ordinary skill in the art.

[0091] As has been set out above, the present invention concerns in one aspect a method for checking one or more parameter(s) of a sample container between the step of filling the sample in the container and the initiation of the transport of said sample container in a sample container rack, wherein said sample container is configured to be placed in a sample container rack designed to receive one or more sample container(s) as a base station.

[0092] The underlying smart analytics concept combines the latest methods of digitiza- tion and innovative medical technology to significantly improve the integrity of human blood and other body fluids, i.e. samples, despite complex supply chains for patients and researchers. The methods for checking or monitoring one or more parameter(s) of a sample container according to the invention allow the user to check, inter alia, the loca tion, temperature and quality of samples in real time, and to read the stored information of the sample process directly from the sample or container rack, e.g. via an App, e.g. the smart4app or on the basis of a network based data management system. The sample containers and the sample container rack within the context of the methods according to the present invention may communicate directly with existing analyzers, e.g. analyz ers of the Cobas platform of Roche or other similar systems, thus reducing the handling effort of the samples. In addition, they may automatically combine the data from the sample course with corresponding analytical data. This ensures that samples which do not meet predefined quality requirements do not enter into the analyzer system, or are re-used by an analyzer. This results in an unprecedented degree of safety, traceability and quality control when using different samples. In addition, the producer of an ana lyzer can convert its own platform into a smart digital device without great overhead, thus implementing its own digitization strategy. [0093] The present invention thus aims at providing methodology for the checking and monitoring of sample containers before and during the transport of blood and other medical samples, as well as communication and software solutions for existing plat forms, e.g. Roche Cobas or LIS forms. In this way, the user receives in real time all im portant quantitative and qualitative data of his samples. Through the communication between the sample container, the sample container rack and the analyzer, a smart cir cuit-based methodology is created for the first time, which automatically prevents the use of qualitatively inferior samples. This creates a hitherto unprecedented level of safety in the field of diagnostics, research and development.

[0094] The presently claimed and herein described technology will raise the safety and traceability of the blood samples to an unprecedented level. The control of all important data in real time drastically reduces the risk of incorrect clinical data due to improper handling and the possibility of manipulation. For the European diagnostics industry alone, for example, a total of approximately 2-3 billion EUR can be saved p.a. Advanta geously, the sample user can track the quality of his sample right from the start. Since there is so far no uniform standard in this area, the present invention also aims at the provision of proposals for a globally valid standard. [0095] The presently claimed and herein described elements generate three immediate benefits: 1. 1. The error rate in clinical diagnostics, especially in pre-analytics, due to incorrectly related samples can be significantly reduced. 2. The creation of a smart, se cure and traceable data record for all clinical samples and the provision of quick feed back possibilities is a necessary step towards the implementation of the clinical trials precision medicine. 3. The costs in preclinical and clinical research can be significantly reduced by means of a high degree of precision, meaningfulness and significantly lower rejects.

[0096] An example of an already existing analyzing system in the field of automated la boratory diagnostics is the Cobas series provided by Roche. The present invention also aims at a further development of existing sample container as smart devices, which com municate independently with, e.g. the Cobas analyzers. Thanks to a Cobas-compatible methodology all necessary steps in the area of sample handling are significantly simpli fied. First, the time- and error-intensive repackaging from previously analog mailboxes in Cobas racks is no longer required. In addition, it is now possible for users, for the first time, to sort and/or treat separate samples, which do not meet the quality requirements already stipulated before dispatch, independently through the Cobas platform. For this purpose, the described methods allow to communicate directly with a receiving station, e.g. the Cobas platform and informs about the data collected so far by it. If these data do not correspond to previously determined parameters, e.g. temperature, route, time or qualitative parameters, the corresponding samples are automatically sorted out, or not measured, e.g. by the Cobas device or handled separately. Further options for sub sequent handling of these samples are also envisaged. In this way, the described meth ods allow for an auto-correction for faulty data and the underlying platform technology, e.g. the Cobas platform, provides its users with an unprecedented, unique analytical safety frame. An interaction as described for the Cobas platform is envisaged also for any other suitable analyzing platforms known to the skilled person.

[0097] The present invention thus generates, for example, at least three immediate benefits: 1. The Cobas platform or any other similar analyzing platform may become a smart device, which comes into contact with the respective samples and exchanges itself about their quality. 2. Platform users get maximum security for the analyses performed on their platform devices. Defective samples are sorted out or handled differently. 3. There are significant cost reductions and time savings for platform users by applying the new methods and approaches.

[0098] A "sample container" as mentioned in the context of the methods according to the invention is meant to be any suitable receptacle which 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 embodiments, the container may further be air-tight so that a gas exchange with the surrounding is avoided. The container may, in certain example be completely empty before a sample is filled in. It is particularly preferred that the container is sterile. In further embodiments, Furthermore, the con tainer may be provided in form or designed to allow for the generation of vacuum in the container after filling. 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. inte- grated into the container. The material and form of the container may further be ad justed to specific national or international regulations as to its properties, size, form etc. 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 assists in preserving the sample. 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 and identified may be present in the container. Alternatively, an electronically identifiable particle may be provided in the container. These elements can either be filled in before the sample is added, or to gether 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. The con- tainer may be provided as insulated container designed to keep the sample at a prede fined temperature range and avoiding a freezing or cooking of the sample. In other em bodiments, 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 ml, 12 ml, 12.5 ml, 15 ml, 20 ml, 25 ml, 30 ml, 35 ml, 40 ml, 45 ml, 50 ml. In certain embodi ments, also sizes smaller than 5 ml or larger than 50 ml are envisaged. The sample con- tainer may be 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 com prise parts of a blood sample or a processed blood sample, e.g. a plasma or serum sam ple. The sample container may also be a biopsy collection tube. Accordingly, the sample container is designed to fulfil all necessary regulatory requirements for biopsy transport, 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 biologi cal 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 re motely locate working groups, geological samples, archeological samples etc.

[0099] A "base station" as mentioned in the context of the methods according to the invention is meant to be a sample container rack, typically an independent sample con tainer rack, which is specifically designed to receive one or more sample container(s) as defined herein. The "sample container rack" may, in particular, be designed in different sizes and forms to accommodate different numbers and forms of sample containers. It may, for example, 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. The sample rack may be designed to accommodate only one size of sample containers, or it may provide space for differently sized sample containers. It is preferred that the sample container rack provides for about 30 to 40 sample contain ers. The sample containers may be accommodated in a tight and anti-slip manner, e.g. allowing for a headfirst transport or for vertical movements of the rack. The sample con tainer rack may also 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 container rack to avoid any displacement. Also envisaged are additional packages such as bags or crates. The use of these packaging variants may depend on the delivery route, the environmental temperature, the transport medium, the transport time etc. and may accordingly be adjusted. The sample container rack may comprise at least one, prefera- bly more than one of the following: (i) An RFID (radio frequency identification) unit, pref erably an RFID reader, which allows to communicate with an RFID component or tag present at or in the sample container as described above. 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 deter mine 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, (ii) A device for determining the temperature of the sample container, preferably a device which allows to determine the temperature at different positions, e.g. the outside and inside of a sample container, (iii) A device capable of de termining vibrations and centrifugal forces exerted on the rack and/or the sample con- tainer 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 regis ter and document geographic changes of the sample container rack. Preferably, a GPS sensor system may be used to track geographic positions. The Global Positioning System (GPS) is a space-based radio navigation 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 provides critical positioning capabilities to military, civil, and commercial users around the world. The present invention further envisages the use of alternative geolo cation systems such as Galileo, Glonass, GSM triangulation or Beidou. In specific embod- iments, more than one geolocation may be used, (v) A device capable of determining time parameters of the sample container rack's use. The device may, for example, reg ister the time and date of a placing of a sample container in the rack and its removal. It may further register the beginning and/or ending of movement phases, e.g. in combina- tion with the geographic tracker and/or the vibrational sensor as described above. Fur thermore, beginning and course of temperature changes may be determined, e.g. in combination with the temperature determining device, (vi) A communication module which allows for wireless communication with a remote receiving station. This commu- nication module is, in certain embodiments, based on high-speed wireless communica tion standards such as LTE (long-term evolution), or GSM/EDGE or UMTS/HSPA technol ogies, 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 mod- ule allows for real-time communication with a remote receiving station. The communi cation may preferably be connected with all other modules in the 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 alterna tive embodiments, the communication module may be capable, or may additionally be capable of transferring data with further protocols such as NarrowBand IOT (NB-loT). NarrowBand loT (NB-loT) is a Low Power Wide Area Network (LPWAN) radio technology standard developed to enable a wide range of devices and services to be connected us- ing cellular telecommunications bands. NB-loT is a narrowband radio technology typi cally 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 pre sent invention further envisages the use of similar technologies such as eMTC (enhanced Machine-Type Communication) and EC-GSM-loT. In further embodiments, the commu- nication module may further be capable of receiving information form a remote receiv ing station, e.g. with respect to encoded patient information, sample shipping destina tions 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 mod ule may be present in or on the sample container, as well as in the sample container rack, (viii) A digital memory module. This memory module may collect and store infor- mation from one or more of the above mentioned module(s) (i) to (v) or (vii). It may serve as documentation center for the 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 receiv ing station, (ix) An acoustic and/or optical alarm module. This module may serve as sig- naling center for the sample container rack during travelling or transport periods inform ing about an abnormal status of samples in the 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 an elimination, (x) An electric power source. In order to be operational, the sample con tainer may have its independent electric power source. This may, for example, be a bat tery or a rechargeable battery. In further embodiments, the electric power may be pro vided 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 tech nology may further be used to recharge batteries of a sample container rack during re covery periods or in a magazine. The power source may be used for the support of one or more of the above mentioned modules, e.g. the communication, tracking, memory, and interaction modules or the alarm modules, (xi) The sample container rack may fur ther 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. [0100] It is particularly preferred that the sample container rack comprises one or more of the following: an RFID (radio frequency identification) unit, a barcode reader, an RFID reader, a digital memory, a data processing unit, a device for determining the tempera ture and/or humidity of the sample container and/or of the sample container rack, a device capable of determining vibrations and centrifugal forces exerted on the rack, a geographic tracking device, preferably a GPS device, a device capable determining time parameters of the sample container rack's use, a light sensor capable of detecting the opening or closing of the sample container rack, an acoustic 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. [0101] The checking of one or more parameter(s) of a sample container as defined above may be performed between the step of filling the sample in a container, e.g. a blood sample as described herein and the initiation of the transport, i.e. the closing of the sample container rack and its handing over to a transport service. The checking may, for example, be performed directly after the samples have been obtained from a pa- tient. It is preferred that the checking is performed immediately after the sample con tainer is filled with the sample or after a pre-treatment of the sample in the container is finished. It is further preferred that the checking is performed before the sample con tainer is transported within the sample container rack to a distant location, e.g. an ana lyzer site. [0102] The checking may comprise one or more parameter(s) selected from:

identity of the sample and/or sample container;

type of sample container, preferably identifiable via a color code;

volume of sample container, preferably identifiable by shape; filling volume of the sample container;

sample number;

specific position of the sample container in the sample container rack;

humidity of the sample and/or sample container;

time parameters of the sample container rack's use;

index of the sample relating to hemolysis, icterus or lipaemia;

- centrifugation status of the sample;

presence of liquid and/or solid phase in the sample;

ratio of liquid and solid phases in the sample;

content of order form attached to the sample container rack; and

[0103] In a particularly preferred 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, 13, or 14 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;

volume of sample container, preferably identifiable by shape;

filling volume of the sample container; 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 sample container rack.

[0104] In a further preferred embodiment, the checking may additionally or alterna tively comprise one, more or all of the following sub-group of parameters: sample number;

specific position of the sample container in the sample container rack;

humidity of the sample and/or sample container;

time parameters of the sample container rack's use;

- index of the sample relating to hemolysis, icterus or lipaemia;

centrifugation status of the sample;

presence of liquid and/or solid phase in the sample;

ratio of liquid and solid phases in the sample;

content of order form attached to the sample container rack; and

- one or more quality parameter(s) of the sample, preferably pH, ionic concentration, and presence of apoptotic, inflammatory or infectious indicators

[0105] 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, planned assays etc.

[0106] The "type of the sample container" may be checked with respect to predeter mined types, e.g. in a color coded manner. For example, sample containers may differ with respect to the subsequent analysis planned, the identity orform of the sample, e.g. whether it is a blood, a serum, a plasma, a urine, a feces sample etc., or the amount of 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 ana lyser location or in a remote server database.

[0107] 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 con tainer, e.g. with specific shapes being associated with certain volumes. [0108] 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 vol ume 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.

[0109] A "sample number" may be provided, e.g. in the form of a barcode, Q.R code or electronically via RFID. Such information may accordingly be checked.

[0110] The "cap color of the sample container" is a parameter which may be linked to the sample type, e.g. blood, serum, urine etc. The parameter may, in alternative embod- iments, 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.

[0111] 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.

[0112] The "color and the shape of the sample container" may also 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, an urine, a feces sample etc., or the amount of sample used, the transport conditions etc. and be verified or compared with information on the sample container present at the analyser location or in the remote server data-base. Also an identification of sample containers via their color and shape, in the form of cap- tured images, is envisaged.

[0113] 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 in creased bilirubin production or inappropriate extraction, e.g. in diseases such as haemo lytic 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. 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.

[0114] 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 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 pre cipitate 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 centrifu gation. Similarly, a ratio of liquid and solid phases may be determined which also allows 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. [0115] The "content of order form attached to the sample container rack" may comprise information on the samples, the origin of the samples, the destination of the transport, the planned analyses etc. Such information may be checked according to the claimed methodology, when the sample containers are provided in the sample container rack. [0116] 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 with a lab-on-a-chip unit (LOC), which is provided on the sample containers or in the sample container rack. The term "lab-on-a-chip unit" or "LOC" refers to a device that integrates one or several la- boratory functions on a single integrated circuit of a few millimeters to a few square centimeters to achieve automation and high-throughput 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 par tially analyzed directly in the sample container rack. For example, a small portion of the sample may be separated from the sample container and transferred by microfluidics to a LOC module, where one or more biochemical or diagnostic assay(s) may be performed.

[0117] 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 vis cosity 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, acti vated caspases (e.g. caspase 2, 3, 7, 8 and 9). Examples of inflammatory indicators may include, but are not limited to cytokines/chemokines (e.g. IL-la, IL-Ib, 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.

[0118] The mentioned parameters may preferably be measured with devices or sensors as described herein. The checking may, in further embodiments, comprise a registering 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 produced and/or a decision as to the fate and future of the sample which is associated with the measured value is started.

[0119] It is preferred that said checking is performed in an automatic manner. One op tion is to use contactless communication between the sample container and the sample container rack or to automatize reading, image capture and recognition activities. For example, the employment of an RFID (radio frequency identification) unit, a Bluetooth interaction, a barcode reading or image capturing is envisaged. The checking may ac cordingly be started automatically once a sample container is placed in a slot, e.g. a spe cifically 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 vi cinity of the registration unit.

[0120] 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. 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 1C programmed with information. Active RFID tags typically possess a microchip circuit (transponder or integrated circuit (1C)) 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 cir cuit through the power obtained from the internal battery.

[0121] 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 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. [0122] 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 (1C), and it may contain the antenna as an integral component of the tag or as a separate device. In passive sys tems, 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 1C can be contained in a single device. However, until operably connected in the device, the antenna and 1C may not interact. Alternatively, the antenna and 1C may be provided on separate compo nents. 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 1C 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 1C and an internal antenna. The tag may, in specific embodiments, comprise an electronic product code (EPC) or a similar code, which is 96 -bit string of data. Also envisaged are alternative codes, which allow to identify a product or element.

[0123] In specific examples, 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, i.e. the sample container rack, the frequencies may be read sequentially or simultaneously. To avoid collision between individual tags, collision detection may be used. To this end typically two different types of protocols are used to singulate a par ticular 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 pa rameter that the tags individually use to pseudo-randomly delay their responses. Alter- natively, an adaptive binary 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.

[0124] 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 frequency of 13.56 MHz, at an ultra-high frequency (UHF) of 433 MHz, 865-868 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.

[0125] In addition to one or more RFID component(s), the sample container may com- prise 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 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.

[0126] In a further embodiment, the 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 indus trial, 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).

[0127] Each sample container may comprise a passive RFID tag which operates at a unique frequency so that each sample container is distinguishable from the other sam- pie containers. If there is more than one sample container in contact with a base station, the frequencies may be read sequentially or simultaneously. To 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 broad- cast an initialization command and a parameter that the tags individually use to pseudo- randomly delay their responses. Alternative, an adaptive binary 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. [0128] The RFID 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 component or tag may preferably be provided in the form of a sticker or adhesive label. [0129] In addition to one or more RFID component(s), the sample container may com prise 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 func tionality. 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, scien- tific and medical (ISM) radio band from 2.400 to 2.485 GHz from fixed and mobile de vices, and a building personal area networks (PANs).

[0130] In an alternative embodiment, said checking is started after a stimulus is trig gered (i) by a sample container passing a mechanic or optical barrier, or (ii) by an oper ator, preferably via manual activation of a start button. [0131] The term "mechanical barrier" as used herein, refers to a physical barrier such as bars or gates and the like. Furthermore a mechanical barrier may be a mechanical sensor that relies on the mechanical deformation of a device which is translated into an elec trical signal. The mechanical deformation can be measured in a number of ways, such as piezoelectricity, piezoresistivity, change in the electric resistance with the geometry, change in the electric capacity, changes in the resonant frequency of vibrating systems. Examples for mechanical sensors include but are not limited to pressure sensors, force and torque sensors, inertial sensors.

[0132] The term "optical barrier" as used herein, relates to a device that converts light rays into electronic signals by measuring the physical quantity of light and translating it into an electrical signal. For example, an optical sensor is capable of measuring changes from one or more light beam(s) which is based around alterations to the intensity of the light. Examples for optical sensors include but are not limited to through beam sensors, reflective sensors and retro reflective sensors. The optical barrier may also refer to op tical units equipped with an emitting diode and reception photodiode, whereby the vis ible and modulated beam emitted by the diode is reflected back by a prism reflector placed opposite to the sensor, then detected by the photodiode which outputs a signal to the processing electronics. Presence of a product is determined depending on whether the beam is blocked or not.

[0133] In a further embodiment, the checking is performed in at least one sample con tainer slot within the sample container rack, which is configured to check one or more parameter(s) of a sample container. Such a slot may fulfil the function 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 sample container rack, which is configured to check one or more parameter(s) of a sample container. The slot is preferably suited to check one or more parameter(s) as mentioned herein. Accordingly, the master check-in slot may be a specific slot in the rack equipped with suitable sensors, a camera, a scanner unit, an RFID unit etc. as mentioned herein to detect one or more parameter(s) as mentioned. In case the order form is to be checked, said order form may, for example, be provided or attached in the vicinity of the mater check-in slot so that a camera or scanner unit is capable of capturing a corresponding image. The obtained parameter values or the in formation on the status of the sample or sample containers or the sample container rack may be stored within the rack or be transmitted to a remote receiving station via a wire less and/or real-time communication.

[0134] In another preferred embodiment, the parameter value is provided in a digital ized 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 orthe information has been provided to a mobile device, in a LIS or in a sample analyzer unit as described herein. [0135] The checking of one or more parameter(s) of a sample container between the step of filling the sample in the container and the initiation of the transport of said sam ple container in a sample container rack may be performed in a parallel or sequential order for two or more sample containers. It is preferred to perform the checking in a sequential order. The termination of the checking may, in specific embodiments, be acknowledged to an operator via an acoustic or optical signal or be indicated in an asso ciated handheld device or in an app on a smartphone or the like. In a particularly pre ferred embodiment the checking of one or more parameter(s) of a second or further sample container only starts after the checking of the previous sample container is fin- ished.

[0136] It is also envisaged that the sample container may be placed in any available slot within the sample container rack. Accordingly, all slots may be equipped with suitable sensors etc. as defined herein in order to perform the checking procedure. In the alter native, the sample container may be placed in a specific, predetermined slot within the sample container rack, preferably a master check-in slot as defined herein.

[0137] In another embodiment, the specific placing in a predetermined slot may addi tionally be checked as a parameter. For example, if a sample container is placed in an arbitrary slot, said slot may be assigned for said sample container. Furthermore the availability of said slot for the placement of other sample containers may be denied to avoid mix-ups. In case a placing is performed in an empty slot which is not identical to the predetermined slot, such an activity may lead to the recognition of the occupied slot and a corresponding assignment of the sample container. Alternatively, the operator may be alerted and informed to relocate the sample container.

[0138] The present invention further envisages that a deviation with respect to the slot position of the sample container within the sample container rack may, in certain em bodiments, lead to a repositioning of the sample container within the sample container rack. Such a repositioning may, preferably be performed via an automatic repositioning mechanic. This mechanic can, for example, be provided by a robotic device. Also envis aged are semi-automatic repositioning options.

[0139] In a further embodiment, a placing in a slot which is not identical to the prede termined slot leads to recognition of the occupied slot and a corresponding assignment of the sample container.

[0140] In a further embodiment, subsequent to each termination of a parameter check ing per sample container a subsequent processing step may be performed. Examples of such additional processing steps are centrifugation of the sample container, attaching a label to the sample container, mixing of the sample container after a predetermined time period, discarding a sample or vortexing the sample container. These processing steps may be performed in the sample container rack or outside of it, e.g. in an addi tional technical module comprising technical machinery such as a centrifugation rotor or a label printer etc. Additionally, these processing steps may also be performed by the user after acoustical or optical display of information about the required steps for fur- ther sample processing at the smart container rack.

[0141] The present invention further envisages that subsequent to each termination of a parameter checking per sample container a status feedback or an alert feedback is provided to a remote receiving station designed to receive in a wireless and/or real-time communication fashion information of a sample container rack, or to a sample analyzer designed to receive one or more sample container rack(s), or to a remote laboratory comprising said sample analyser, or to an operator handling the sample container or the system. The alert feedback may further be provided if a checked parameter deviates from a predetermined value.

[0142] The term "remote receiving station" as mentioned herein is provided as a net- work based database server, which is connected to the sample container rack. The pre sent invention accordingly also envisages, in a further independent aspect, an independ ent remote receiving station, which is connected in a wireless communication fashion with one or more component(s) of the sample container transport concept of the pre sent invention. For example, the remote receiving station is connected to the sample container rack. In addition, the remote receiving station may be connected to further components which may contribute to the organization and/or management of the sam- pie transport and/or subsequent sample analysis. For example, the remote receiving station may be connected to the sample container rack, to an analyzer device, which is designed to further process the sample and/or perform diagnostic, biochemical or chemical assays, to a device directly associated with a patient, e.g. a handheld device such as a smartphone or a tablet PC, or a wearable, which accumulates patient specific information, e.g. on blood pressure or cardiac rhythm, 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 computer. 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 fil tered according to necessities and requirements, e.g. predefined information hierar chies 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 archi- tecture, 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, sub systems 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 phys ical server may further be distributed logically into two or more logical servers. Corre sponding services are offered by several companies, including Amazon, Google, IBM and Microsoft. The envisaged remote receiving station is further designed to receive in a wireless and/or real-time communication fashion information of a sample container rack, i.e. a parameter checked as defined herein. This information may be accumulated or stored in the server, e.g. in a suitable database format. The information may, in fur ther embodiments, be used for a decision making process and/or organizational deci- sions as to the fate and future of a specific sample, and/or as to potential further activi ties associated with a patient, e.g. additional sample taking etc.

[0143] The term "sample analyzer" as used herein, relates to a device which is designed to receive one or more sample container rack(s) as described herein. The sample ana lyzer may further be equipped with an RFID reader which allows for (a) the coupling with a sample container rack RFID tag providing information on the rack's content and/or (b) with one or more sample container(s) comprising also RFID tags providing information on the container's content, the patient etc. The analyzer may also comprises a commu nication module allowing for wireless and/or real-time communication with either the 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 above, or with a sample analyzer system, preferably an LIS (Laboratory Information System). 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 fur- ther 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 parame ters of a sample. The sample analyzer may further allow for wireless and/or real-time communication with a web-based server system feeding a dashboard. The term "dash- board" as used herein relates to an overview of key parameters or indicators in a report format. The information is preferably provided on a web page which is linked to a data base, e.g. the remote receiving station as defined herein, that allows the report to be constantly or periodically updated. The term "dashboard" as used herein relates to an overview of key parameters or indicators in a report format. The information is prefer ably provided on a web page which is linked to a database, e.g. the remote receiving station as defined herein, that allows the report to be constantly or periodically updated.

[0144] The sample analyzer may also be capable of organizing one or more sample con- tainer rack(s) according to further steps to be performed, e.g. according to the sample type, the assay to be performed, the fate of the sample. Furthermore, the analyzer may comprise components which allow a partition of a sample into sub-portions so that dif ferent assays may be performed with one sample. Also envisaged is a module which allows for a subsequent storage of samples, e.g. a refrigerator or freezing device, or ef- fector elements such as a heater or cooler which may be used to modulate the temper ature of a sample or of reagents. The analyzer comprises further, for example, modules for one or more different or one or more similar assay(s), e.g. a nucleotide amplification or sequencing module, a peptide or protein detection module, a metabolite detection module, a pH sensor, a sensor for ionic concentrations, an antibody binding section etc. Also envisaged is the presence of reaction zones, which comprise one or more reagent(s) necessary for the performance of an assay, e.g. buffers, ions, nucleotides, antibodies etc. The analyzer may further or alternatively be equipped with an image recognition module. For example, a microscopic module may be present which allows for visible or UV image taking. The analyzer may accordingly also be equipped with microfluidic ele- ments, which allow to transport samples or sample portions to different areas of the device. Furthermore, robotic components including robotic arms etc. may be included. In further embodiments, the analyzer may be used in combination with one or more further analyzer(s). For example, a chain or conveyer structure may be provided in which a sample is analyzed by 2 or more analyzers in a row. These analyzers may further be connected and/or share data with each other and/or the remote receiving station. In further embodiments, the analyzers may be integrated in a laboratory management sys tem, e.g. a laboratory information management system. Accordingly, exchange of data and information may be implemented in the system. The system may further be con nected to hospital systems or database structures. In further embodiments, the analyzer may additionally comprises one or more processing unit(s), which are capable of sorting and/or opening and/or labeling and/or tapping a sample container. Also envisaged are processing units which are capable of taking an aliquot of the content comprised in a sample container. The present invention additionally envisages further processing units known to the skilled person as being typically comprised in an LIS or analyzer system, e.g. the Cobas platform.

[0145] The term "LIS" as used herein refers to an information management system, typ ically comprising a complex of hardware and software components that support the management of collection, processing, storage, distribution, and information represen- tation 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 function(s): (i) enrolment of samples, i.e. the assignment or reception of a unique identifier and record ing 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. dis- play of a list of all required tests in combination with monitoring of the execution of assigned analyses, or tracking of time; (iii) 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 sta tistical 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 in cluded; (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).

[0146] The term "status feedback" relates to the conveying of information on the status of certain parameters concerning the sample and/or sample container rack. The status feedback may, for example, comprise a simple summary of the performed checking of one or more of the parameter(s) mentioned herein. Also included may be a time stamp of the checking or an information about the planned next steps, expected arrival times of the rack, successful data transmission to remote receiving station etc. [0147] The term "alert feedback" relates to the conveying of information on the devia tion of a checked parameter from a predetermined value. The deviation may be an mis matching of a parameter with a predetermined value, a missing value for checked pa rameter or an unsuccessful checking procedures, a proportional deviation from a pre- determined value, e.g. of about 10 % of filling volume, the detection of a specific color or its proportional grading from a predetermined value, e.g. reddish sample color or the non-detection of a solid phase in a sample etc.

[0148] The remote receiving station as defined herein may comprise or implement an assessment and decision unit, typically in the form of a suitable program or software, which determines, for example, on the basis of the parameters as described herein that a status feedback or alert feedback is provided, and/or which subsequent step is to be performed with the sample container or the sample container rack. The decision unit may accordingly be provided in a cloud-based computer server system. Alternatively, the decision unit may be provided locally in the sample container rack, e.g. as program or software present in a microprocessor. Also envisaged is the presence and use of a decision unit in an LIS as defined herein.

[0149] In another aspect, the invention relates to a method for monitoring one or more parameter(s) of a sample container as defined herein between the step of filling the sample in the container and the analysis of the sample. The monitoring thus typically covers the transport period from the sample collection site to the site where the analysis is performed. In specific embodiments said monitoring is performed during the storage, transport and/or geographical relocation of the sample container in said sample con tainer rack.

[0150] The parameters which are monitored comprise one or more selected from: - identity of the sample and/or sample container, as defined herein above;

time parameters of the sample container rack's use; vibrations of the sample and/or sample container; and/or exerted centrifugal forces top the sample and/or sample container;

light intensity on the sample;

opening or closing of the sample container rack;

- filling volume of the sample container, as defined herein above;

potential hemolysis, icterus or lipaemia in the sample container, as defined herein above;

geographic tracking information of the sample container; and

one or more quality parameter(s) of the sample, preferably pH, ionic concentration, and presence of apoptotic, inflammatory or infectious indicators, as defined herein above.

[0151] In typical embodiments, the mentioned parameters may be measured and mon itored with devices or modules as defined herein above in the context of the sample container rack. For example, the identity of the sample may be monitored with an RFID (radio frequency identification) unit, preferably an RFID reader or a similar unit as de fined herein. For example, the temperature of the sample and/or sample container and/or sample container may be measured or monitored with a device for determining the temperature of the sample container, preferably a device which allows to determine the temperature at different positions, e.g. the outside and inside of a sample container as defined herein above. The humidity of the sample may be measured or monitored with a device for determining humidity such as a hygrometer, preferably an electronic hygrometer. Vibrations of the sample and/or sample container and/or exerted centrif ugal forces to the sample and/or sample container may be measured or monitored by a device which is capable of registering, documenting and categorizing vibrations and/or gravitational changes, e.g. due to pressure changes, downfalls, fast horizontal or vertical movements such as a piezoelectric device. Light intensity on the sample and/or opening or closing of the sample container may be measured or monitored with a light sensor module, which can, for example, be placed as a light sensor module directly on the sam ple container, thus allowing for a light intensity check at the first moment of filling the sample or may be present in or on the sample container, as well as in the sample con tainer rack. For example, the geographic tracking information of the sample container may be monitored with a device which is designed to register and document geographic changes of the sample container rack such as a GPS sensor system or a system based on alternative geolocation systems such as Galileo, Glonass or Beidou.

[0152] In a further aspect, the present invention refers to a method for recording a tem perature parameter history log of an individual sample container in a sample container rack as defined herein. Accordingly, any change in temperature within or outside the sample, the sample container and/or the sample container rack may be measured and/or monitored with a temperature sensor. Temperature sensors typically measure the amount of heat energy or coldness that is generated by an object or system, allowing to detect any physical change to that temperature producing either an analogue or dig ital output which can be recorded. Examples of temperature sensors include, but are not limited to, alcohol or mercury based thermometers, thermostats, thermistors, or infrared temperature sensors. Output signals produced by temperature sensors may be converted into electrical signals by signal conditioning and transmission depending on the sensors used. Said conversion may be performed by electrical transducers which are capable of converting physical quantities into electrical quantities. Exemplarily, a ther mocouple may be used that changes temperature differences into a small voltage. The term "history log" as used herein relates to the measurement and optional storage of temperature values during a specific period of time, e.g. during the transport of a sample container rack as defined herein, or from inserting a sample container in the rack until the delivery of the sample container to an analyzer or analyzer system as defined herein, or any sub-portion of said period of time. The measurements may be performed in a continuous manner, or may be performed periodically, e.g. every 0.1, 0.5, 1, 2, 3, 4, 5, 10, 15, 20, 30, 40, 60, 120 min, 3 h, 4 h, 5 h, 6 h, 24h or more, or any value in between the mentioned values. The history log may accordingly be recorded in any suitable place or device, e.g. within a sample container rack, or at a remote receiving station as defined herein. The history log may further be available on potentially connected devices such as handheld devices or smartphones, LIS or sample analyzer technology units etc. Also envisaged is the presentation on dashboards as described herein and the opportunity for its printing, exporting or archiving in any electronic format, e.g. text files.

[0153] In a specific embodiment, said temperature parameter history log is used to re- construct the approximate sample collection time point. For example, the decrease or increase of temperature over a defined period of time may be registered and compared with the temperature at the point in time of entering a sample container to the sample container rack. Furthermore, a comparison with environmental temperatures may be performed to allow for a calculation the period of time which has lapsed since a first or initial measurement, e.g. when checking in the sample container, was performed.

[0154] In yet another embodiment, said reconstruction is further based on additional parameter values from the sample container rack such as sample filling volume, sample container type, humidity orfurther parameters. These values may be integrated into the reconstructive calculation of the approximate sample collection time point, e.g. on the basis of the decrease or increase of temperature of the sample in a defined period of time.

[0155] It is particularly preferred that the checked, monitored and/or recorded param eters as defined above, or the temperature parameter history log as defined above, is/are transmitted to a remote receiving station as defined above. Said transmission of parameter values or logs may be performed once, e.g. a specific point in time such as 10 min, 20 min, 30 min, 60 min, 2 h etc. after the first contact between the sample container and the sample container rack, or 10 min, 20 min, 30 min, 60 min, 2 h etc. after the transport of the sample container rack has started. Alternatively, the transmission may be performed several times, e.g. after an adjustable period of time, e.g. every 0.1, 0.5, 1, 2, 3, 4, 5, 10, 15, 20, 30, 40, 60, 120 min, 3 h, 4 h, 5 h, 6 h, 12 h, 24 h etc. Also envisaged is that the transmission is started after one or more specific, e.g. predetermined, geo graphical checkpoint(s) have been reached or passed, e.g. determinable via a GPS func tionality as defined herein. In a further alternative, the transmission may be started after one or more parameter(s) as described herein above are successfully collected. It is par ticularly preferred that said transmission is automatic. Also othertransmission forms are envisaged, e.g. a semi-automatic version, wherein an operator is asked for permission, or a purely operator-controlled transmission. [0156] It is particularly preferred that the transmission of parameters is initiated imme diately after the placement of the sample container in the sample container rack, more preferably before the sample container rack's transport is started.

[0157] Transmitted parameters as defined herein above may be recorded in any suita ble manner, preferably in a remote computer sever system as defined herein. It is par- ticularly preferred that the transmitted parameters or parameter values are recorded in a cloud based computer server system. In a further embodiment, transmitted parameter values may additionally be aggregated, e.g. in a specific data format, summarized, e.g. in a specific report format, and/or assessed. The assessment may, for example, include a comparison with reference values, e.g. derivable from a database. These activities are preferably performed in an automatized manner.

[0158] In a further embodiment, checked or monitored parameter values may be deliv ered to a sample analyzer as defined herein, or to a remote laboratory comprising said sample analyser. It is particularly preferred that the received parameter values are inte grated into the sample analyzer system. Also envisaged is the integration into an LIS or sample analyzer technology unit. In a specific embodiment, said parameter value inte gration is performed via a cloud-based server system automatically, periodically or by request, e.g. after sending the request for a specific barcode of a sample container, or after the sample container has arrived at or was registered by the LIS.

[0159] In yet another embodiment, the received parameters values are provided in the form of a dashboard as defined herein, preferably per each sample container or per sample container rack. The information may accordingly be provided on a web page which is linked to a database, or be provided as raw data stream, preferably to an oper ator. Also envisaged is the provision of the received parameters values in a filtered and/or assessed form in a signal light format. This provision is typically directed to an operator. [0160] In another preferred embodiment, the fact that parameters have been checked and no deviation from a predetermined value has been detected, is transmitted to a remote receiving station as defined herein in the form of a contentless short signal, e.g. an SMS notice.

[0161] In a further aspect, the present invention relates to a computer implemented method for checking one or more parameter(s) of a sample container between the step of filling a sample in the container and the analysis of the sample. In a preferred embod iment, the parameters to be checked comprise or consist of:

identity of the sample and/or sample container;

type of sample container, preferably identifiable via a color code;

- volume of sample container, preferably identifiable by shape;

filling volume of the sample container;

sample number;

specific position of the sample container in the sample container rack;

temperature of the sample and/or sample container and/or sample container rack, preferably at the point of sample container placement in the sample container rack;

humidity of the sample and/or sample container;

time parameters of the sample container rack's use;

index of the sample relating to hemolysis, icterus or lipaemia;

- centrifugation status of the sample;

presence of liquid and/or solid phase in the sample;

ratio of liquid and solid phases in the sample;

content of order form attached to the sample container rack; and one or more quality parameter(s) of the sample, preferably pH, ionic concentration, and presence of apoptotic, inflammatory or infectious indicators, preferably as defined herein above.

[0162] Also envisaged is a computer implemented method for checking one or more parameter(s), wherein said parameters are derived from a sub-group as defined herein above.

[0163] In yet another aspect, the present invention relates to computer implemented method for monitoring one or more parameter(s) of a sample container between the step of filling a sample in the container and the analysis of the sample, wherein said parameters comprise:

identity of the sample and/or sample container;

time parameters of the sample container rack's use;

light intensity on the sample;

opening or closing of the sample container rack;

filling volume of the sample container; and

- potential hemolysis, icterus or lipaemia in the sample container.

[0164] In a further aspect, the present invention relates to method for assessing the parameters as described herein above with respect to deviation from a predefined value.lt is preferred that each parameter deviation leads to a status feedback or an alert feedback, which is provided to a remote receiving station as defined herein, or to a sam- pie analyzer as defined herein, or to a remote laboratory comprising said sample ana lyser, or to an operator handling the sample container or the system. [0165] Also envisaged is, in another aspect of the invention, a data processing device comprising means for carrying out a method as defined herein above.

[0166] In yet another aspect, the present invention relates to computer program com prising instructions which, when the program is executed by a computer, cause the com- puter to carry out the method as defined herein above.

[0167] In further embodiments, the methods as defined herein above additionally com prises the step of monitoring further parameters of a patient whose sample is to be analyzed. For example, the methods may additionally comprise the measurement of a patient's pulse and/or blood pressure and/or cardiac rhythm and/or blood glucose level and/or oxygen supply and/or stress status or any subgroup or grouping of these param eters. The corresponding measurement may, for example, be implemented in a weara ble, which is used by the patient. Furthermore, it is preferred that the additional meas urement is performed in a period of time immediately before, during or after a sample has been taken from said patient. This time connection to the sample taking is assumed to allow for a conclusion on the sample quality on the basis of the additionally measured parameters. For example, a high degree of stress as measured my lead to the decision to repeat the sample taking and to disregard the samples taken so far. Alternatively, the presence of a high glucose amount may lead to a decision on specific assays to be per formed, e.g. diabetes related diagnostics etc. [0168] 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++, C#, 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 instruc- tions 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 device or provided separately from other devices (e.g., via Internet download). Any such computer readable medium may reside on orwithin 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 capa ble 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 infor mation, the organization and management of data from one to many sample rack enti- tie(s) or wearable(s) and the presentation of information on one or more different in- terface(s) such as a web-interface or a tablet or smartphone app.

[0169] Any of the monitoring methods described herein may be totally or partially per formed 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 monitoring 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 of a step may be optional. Additionally, any of the steps of any of the methods can be per formed with modules, circuits, or other means for performing these steps.

[0170] 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 principles laid out herein.

Claims

1. A method for checking one or more parameter(s) of a sample container be tween the step of filling the sample in the container and the initiation of the transport of said sample container in a sample container rack, wherein said sample container is configured to be placed in a sample container rack de signed to receive one or more sample container(s) as a base station.

2. The method of claim 1, 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;

- sample number;

specific position of the sample container in the sample container rack; temperature of the sample and/or sample container and/or sample container rack;, preferably at the time point of sample container placement in the sample container rack;

- humidity of the sample and/or sample container;

time parameters of the sample container rack's use;

index of the sample relating to hemolysis, icterus or lipaemia; centrifugation status of the sample;

presence of liquid and/or solid phase in the sample;

- ratio of liquid and solid phases in the sample;

content of order form attached to the sample container rack; and one or more quality parameter(s) of the sample, preferably pH, ionic concentration, and presence of apoptotic, inflammatory or infectious indicators.

3. The method of claim 1 or 2, wherein said checking is performed in an auto matic manner via contactless communication between the sample container and the sample container rack by RFID (radio frequency identification), Blue- tooth interaction, barcode reading or image capture, or wherein said check ing 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 ac tivation of a start button.

4. The method of any one of claims 1 to 3, wherein said checking is performed in at least one sample container slot within the sample container rack, which is configured to check one or more parameter(s) of a sample container.

5. The method of any one of claim 1 to 4, wherein the parameter value is pro vided in a digitalized form.

6. The method of any one of claims 1 to 5, wherein the checking of one or more parameter(s) of a sample container between the step of filling the sample in the container and the initiation of the transport of said sample container in a sample container rack is performed in a sequential order for two or more sample containers.

7. The method of any one of claims 1 to 6, wherein said sample container can be placed in any available slot within the sample container rack, or wherein said sample container is placed in a specific, predetermined slot within the sample container rack.

8. The method of claim 7, wherein the specific placing in a predetermined slot is checked as an additional parameter.

9. The method of claim 7 or 8, wherein a placing in a slot which is not identical to the predetermined slot leads to recognition of the occupied slot and a cor responding assignment of the sample container.

10. The method of any one of claims 6 to 9, wherein the checking of one or more parameter(s) of a second or further sample container starts after the check ing of the previous sample container is finished.

11. The method of claim 10, wherein subsequent to each termination of a pa rameter checking per sample container a status feedback or an alert feed back is provided to a remote receiving station designed to receive in a wire less and/or real-time communication fashion information of a sample con tainer rack, or to a sample analyzer designed to receive one or more sample container rack(s), wherein said sample analyzer comprises an RFID reader, an Bluetooth device, an barcode reader, an interface between said reader and an analyzer information technology unit, and a communication module al lowing for wireless and/or real-time communication with a remote receiving station, or to a remote laboratory comprising said sample analyser, or to an operator handling the sample container or the system.

12. The method of claim 11, wherein the alert feedback is provided if a checked parameter deviates from a predetermined value.

13. The method of claim 12, wherein a decision unit provided locally in the sam ple container rack and/or in a cloud-based computer server system, or in LIS, or a mobile device or in a sample analyzer unit provides the alert feedback.

14. The method of claim 12 or 13, wherein a deviation with respect to the slot position of the sample container within the sample container rack leads to a repositioning of the sample container within the sample container rack, pref erably via an automatic repositioning mechanic such as a robotic device.

15. The method of claim 11, wherein subsequent to each termination of a pa rameter checking per sample container a subsequent processing step is per formed such as centrifugation of the sample container, attaching a label to the sample container, mixing of the sample container after a predetermined period, discarding a sample or vortexing the sample container.

16. A method for monitoring one or more parameter(s) of a sample container between the step of filling the sample in the container and the analysis of the sample, wherein said sample container is configured to be placed in a sample container rack designed to receive one or more sample container(s) as a base station.

17. The method of claim 16, wherein said parameters comprise one or more se lected from:

- identity of the sample and/or sample container;

temperature of the sample and/or sample container and/or sample container rack;

humidity of the sample and/or sample container;

time parameters of the sample container rack's use;

light intensity on the sample;

opening or closing of the sample container rack;

filling volume of the sample container; potential hemolysis, icterus or lipaemia in the sample container;

geographic tracking information of the sample container; and one or more quality parameter(s) of the sample, preferably pH, ionic concentration, and presence of apoptotic, inflammatory or infectious indicators.

18. The method of claim 16 or 17, wherein said monitoring is performed during the storage, transport or geographical relocation of the sample container in said sample container rack.

19. The method of any one of claims 1 to 18, wherein said sample container rack comprises one or more of the following: an RFID (radio frequency identifica tion) unit, a barcode reader, an RFID reader, a digital memory, a data pro cessing unit, a device for determining the temperature and/or humidity of the sample container and/or of the sample container rack, a device capable of determining vibrations and centrifugal forces exerted on the rack, a geo graphic tracking device, preferably a GPS device, a device capable determin ing time parameters of the sample container rack's use, a light sensor capable of detecting the opening or closing of the sample container rack, an acoustic alarm module, an electric power source, preferably a battery, and a commu nication module allowing for wireless and/or real-time communication with a remote receiving station.

20. A method for recording a temperature parameter history log of an individual sample container in a sample container rack, wherein said sample container is configured to be placed in a sample container rack designed to receive one or more sample container(s) as a base station.

21. The method of claim 20, wherein said temperature parameter history log is used to reconstruct the approximate sample collection time point.

22. The method of claim 21, wherein said reconstruction is further based on additional parameter values from the sample container rack such as environmental temperature, humidity, or light exposure.

23. The method of any one of claims 1 to 22, wherein the checked, monitored and/or recorded parameters are transmitted to a remote receiving station designed to receive in a wireless and/or real-time communication fashion in formation of a sample container rack.

24. The method of claim 23, wherein the transmission can be performed once or several times such as after an adjustable period of time or after specific geo graphical checkpoints have been reached, or after one or more parameter(s) as defined in claim 2 or claim 17 are successfully collected, wherein said transmission is preferably automatic.

25. The method of claim 23 or 24, wherein transmitted parameters are recorded in a remote computer sever system, preferably in a cloud based computer server system.

26. The method of claim 25, wherein transmitted parameter values are aggre gated and/or assessed, preferably in an automatized manner.

27. The method of any one of claims 1 to 26, wherein checked or monitored pa rameter values are delivered to a sample analyzer designed to receive one or more sample container rack(s), wherein said sample analyzer comprises an RFID reader, an interface between said reader and an analyzer information technology unit, and a communication module allowing for wireless and/or real-time communication with a remote receiving station, or to a remote la boratory comprising said sample analyzer.

28. The method of claim 27, wherein received parameter values are integrated into the sample analyzer system, preferably a LIS.

29. The method of claim 28, wherein said parameter value integration is per formed via cloud-based server system.

30. The method of claim 28 or 29, wherein said integration is performed in an automatic manner or via an ID request.

31. The method of any one of claims 27 to 30, wherein the received parameters are provided in the form of a dashboard, preferably per each sample con- tainer or per sample container rack, or are provided as raw data stream, pref erably to an operator, or are provided in a filtered and/or assessed form in a signal light format, preferably to an operator.

32. The method of any one of claims 23 to 31, wherein said transmission of pa rameters is initiated immediately after the placement of the sample con tainer in the sample container rack, preferably before the sample container rack's transport is started.

33. The method of any one of claims 1 to 22, wherein the fact that parameters have been checked and no deviation from a predetermined value have been detected, is transmitted to a remote receiving station designed to receive in a wireless and/or real-time communication fashion information of a sample container rack in the form of a contentless short signal.

34. A computer implemented method for checking one or more parameter(s) of a sample container between the step of filling the sample in the container and the initiation of the transport of said sample container in a sample con tainer rack, wherein said parameters comprise:

- identity of the sample and/or sample container;

type of sample container, preferably identifiable via a color code;

sample number;

- specific position of the sample container in the sample container rack; temperature of the sample and/or sample container and/or sample container rack, preferably at the time point of sample container placement in the sample container rack;

humidity of the sample and/or sample container;

- time parameters of the sample container rack's use;

presence of liquid and/or solid phase in the sample;

ratio of liquid and solid phases in the sample;

- content of order form attached to the sample container rack; and

35. A computer implemented method for monitoring one or more parameter(s) of a sample container between the step of filling a sample in the container and the analysis of the sample, wherein said parameters comprise:

identity of the sample and/or sample container;

temperature of the sample and/or sample container and/or sample container rack;

humidity of the sample and/or sample container;

time parameters of the sample container rack's use;

light intensity on the sample;

opening or closing of the sample container rack;

filling volume of the sample container; and

potential hemolysis, icterus or lipaemia in the sample container.

36. A computer implemented method for assessing the parameters as defined in claim 34 or 35 with respect to deviation from a predefined value.

37. The method of claim 36, wherein each parameter deviation leads to a status feedback or an alert feedback, which is provided to a remote receiving station designed to receive in a wireless and/or real-time communication fashion in formation of a sample container rack, or to a sample analyzer designed to receive one or more sample container rack(s), wherein said sample analyzer comprises an RFID reader, an Bluetooth device, an barcode reader, an inter- face between said reader and an analyzer information technology unit, and a communication module allowing for wireless and/or real-time communica tion with a remote receiving station, or to a remote laboratory comprising said sample analyser, or to an operator handling the sample container or the system.

38. A data processing device comprising means for carrying out the method of any one of claims 1 to 33.

39. A computer program comprising instructions which, when the program is ex ecuted by a computer, cause the computer to carry out the method of claim 1 to 33.