EP4189692A1

EP4189692A1 - Pre-analytic management of sample container parameters

Info

Publication number: EP4189692A1
Application number: EP21755911.1A
Authority: EP
Inventors: Yannick Thimotheus BOEGE; Julia Floetotto; Hans Maria HEYN; Malte DANCKER
Original assignee: Smart4diagnostics GmbH
Current assignee: Smart4diagnostics GmbH
Priority date: 2020-07-29
Filing date: 2021-07-29
Publication date: 2023-06-07
Also published as: WO2022023481A1

Abstract

[0136] The present invention relates to a sampling method for taking a subject's liquid sample and for obtaining, processing, storing and optionally transmitting pre-analytical values for sample parameters or sample-associated parameters, comprising the steps of (i) registering one or more parameter values(s); (ii) taking a subject's sample and subse- quently registering one or more parameter values; (iii) processing, storing and optionally transmitting said parameters wherein said parameter value(s) is/are registered, pro- cessed, stored and optionally transmitted by a sample-container-like-sensor-and-inter- action tube, which is brought into physical vicinity of the sample container before sam- ple taking and kept in physical vicinity of the sample container during the pre-analytical phase, preferably until arrival at the analytic.

Description

Pre-analytic management of sample container parameters

FIELD OF THE INVENTION

[0001] The present invention relates to a sampling method for taking a subject's liquid sample and for obtaining, processing, storing and optionally transmitting pre-analytical values for sample parameters or sample-associated parameters, comprising the steps of (i) registering one or more parameter values(s); (ii) taking a subject's sample and subse quently registering one or more parameter values; (iii) processing, storing and optionally transmitting said parameters wherein said parameter value(s) is/are registered, pro cessed, stored and optionally transmitted by a sample-container-like-sensor-and-inter- action tube, which is brought into physical vicinity of the sample container before sam ple taking and kept in physical vicinity of the sample container during the pre-analytical phase, preferably until arrival at the analytic.

BACKGROUND OF THE INVENTION

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

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

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

[0005] Alarmingly, 70% of all mistakes made in medical diagnostics occur in the pre- analytical phase, most of which arise from problems in patient preparation, sample col lection and transportation at site of sample collection (West et al., Annals of Clinical Biochemistry, 2017). In particular, pre-analytical multiple steps are highly error-prone. Already before sample collection, ordering the right laboratory test at the right time for the right patient shall be quite easy, especially when electronic order-entry systems are being used. However, this approach often leads to the phenomenon of overutilization of laboratory tests, or results in the selection of inappropriate tests due to unknown or not consistent test abbreviations. In addition, preparation of sample collection tubes, including the selection of the correct primary sample collection tube, characterized by a manufacturer-specific cap color code, indicating chemical agents added to the tube dur ing the production phase to allow or inhibit specific biochemical reactions (e.g. coagula- tion) or stabilize specific biomarkers (see Sarstedt AG & Co KG, Niimbrecht, Colour cod ing in blood collection, 2018) and labelling it with the correct and patient-specific bar code or label, is highly error-prone. Sample tubes, barcodes and the identity of the pa tient must be verified during or directly after sample collection. Especially if collection tubes are prepared with barcodes at an earlier time-point, wrong sample tubes may po tentially be used, or they may be linked to the wrong patient (von Meyer et al., 2019, Diagnosis, 6(1), 1-3). Thus, verification of a patient's identity is absolutely essential as well as identification of healthcare practitioner taking blood is already legally mandatory for some specific blood sample collections, e.g. cross-matching blood samples for blood compatibility tests ("Richtlinie der Bundesarztekammer zur Qualitatssicherung labora- toriumsmedizinischer Untersuchungen" (Rili-BAK)) and of growing interest due to the increasing fragmentation of the diagnostic process. In order to avoid these problems, different sample tubes must be treated in different ways according to manufacturer's protocol upon sampling. The procedures include mixing blood with additives, followed by a specific incubation time at a specific temperature, e.g. 30 minutes at room temper ature. Subsequently, it may be necessary to centrifuge the samples, e.g. at 1000 g for 10 minutes at 18 - 25 °C. Finally, the samples must be stored under specific temperature conditions until processing in the analytical phase or transport to an analytic site (Sar stedt AG & Co KG, Niimbrecht, Tips & Techniques in Preanalytics, 2018). Nevertheless, elapsed time between sampling and analysis must not exceed specific individual thresh olds since analytical biomarkers shall be metabolized in the blood sample or degrade e.g. due to environmental influences like temperature changes.

[0006] In a hospital setting the transport is typically performed in-house via a pneumatic tube system or by personal delivery. For settled practitioners and outpatients' settings samples are normally picked up once a day by courier service and often travel a few hundred kilometers to their destination to be analyzed by laboratory service providers. Upon arrival in the laboratory, samples are registered and processed. Between 6 - 10 % of all samples are currently processed manually at this stage. This activity and connected trouble shooting efforts already comprise about 25 % of the lab operational staff costs. Most of these samples typically need manual handling because they are negatively af fected by pre-analytical errors such as wrong tube allocation, wrong label placements, mislabeling, low filling volumes, hemolysis, non-conforming mapping of lab orders or sample barcodes, missing or redundant samples or lab orders etc. These complications strongly compromise the samples' quality already before their arrival in the laboratories and lead to additional manual labor at sample entry to assure quality. The total costs for processing a sample manually due to any of these errors is assumed to be at least twice the cost of an automated processing. Furthermore, an additional 5 % of all goods and consumables must be spent to achieve reimbursable results due to repetitive measure ments.

[0007] Detecting and reducing these pre-analytical errors automatically at the point of blood collection is believed to significantly improve medical quality and cut short the spending of an average laboratory by at least 10 %. Thus, automation and efficiency are key for further profits and key driver of innovation in this highly competitive market. Increased diagnostic quality, improved patient safety, easier compliance with regulatory guidelines (e.g. ISO 15189:2012, Rili-BAK-2019) and competitive advantages constitute additional values. In particular, regulatory compliance is essential for medical laborato ries with respect to their accreditation. According to the International Standard for med ical laboratories accreditation (ISO 15189: 2012) "the laboratory shall establish quality indicators (Ql) to monitor and evaluate performance throughout critical aspects of pre examination, examination and post-examination processes" and "the process of moni toring Qls shall be planned, which includes establishing the objectives, methodology, interpretation, limits, action plan and duration of measurement". Therefore, the estab lishment of Qls covering the entire diagnostic process should be considered "a must" for complying with the requirements of the International Standard and achieving accredita tion. Recommended Qls are for example misidentified sample misidentified patients, unlabeled samples, wrong sample tube type, inappropriate sample type, incorrect fill level, samples clotted or hematology/coagulation status (Plebani et al., 2015, Clin Chem Lab Med, 53(6), 943-948). During the last decades blood-based tests were improved by developing technically advanced laboratory analyzers by focusing on the analytical pro cedures in the lab, leading to a technical error rate below 0.1 % today. Internal quality controls (QCs) are mandatory for technical validation of laboratory analyzers to ensure analytical quality and to prevent the release of erroneous results and ultimately avert patient harm.

[0008] However, quality strategies typically focus on the technical validation of labora tory analyzers in the analytical phase whereas blood sample integrity, early steps in the pre-analytical phase and their integration in an efficient overall concept have not yet been addressed in an efficient manner. Thus, samples with uncontrolled quality arrive in the laboratory as well as an unknown number of samples at an unpredicted time point. Next, samples are introduced manually by laboratory technicians or automatically by so called samples processing modules, e.g. sample sorters (single or bulk sorters) into the fully automated laboratory at a single point of entry according to the first-in -first- out principle (see G Lippi, Clinical Chemistry and Laboratory Medicine, 2019, 57(6) 802- 811). Thus, samples with different priority levels, e.g. a) emergency / b) result required the same day, c) result expected the next day (lowest priority) are mixed and introduced. Also, the sequence of tests performed on the different laboratory analyzer modules is determined by the sequence of incoming samples. The test sequence is therefore po tentially time consuming and a predictive planning laboratory test performance us re- quired to improve total turnaround time. Furthermore, medical validation of test results is based on reference values and internal technical quality controls. As described, sam ple history is not considered (e.g. elapsed time of time critical tests) as well as most importantly verification of patient identification (see Patient and Sample Identification. Out of the Maze?, G- Lippi et al, 2017; 36(2): 107-112). [0009] There is hence a need for creative and effective solutions for a seamless and traceable quality assurance approach for human samples, which specifically allows to monitor error-prone pre-analytical steps. Moreover, there is an increasing need for a linkage between sample collection/delivery parameters, insertion into the highly auto mated laboratory process and the management of associated patient data such as per sonal information, sampling time and place, or an urgency status for the required test results.

OBJECTS AND SUMMARY OF THE INVENTION

[0010] The present invention addresses this need and provides in one aspect a sampling method for taking a subject's liquid sample and for obtaining, processing, storing and optionally transmitting pre-analytical values for sample parameters or sample-associ ated parameters, comprising the steps:

(i) registering one or more of the parameter values(s): time of registration of a subject at a sample collection site before the sample is taken; identity of the subject before the sample is taken; the subject's personal data before the sample is taken; health condition of subject before the sample is taken; identity and location of the sample collection site before the sample is taken; identity of the person drawing the subject's sample (phle- botomist) before the sample is taken; sample type before the sample is taken; intended test for sample before the sample is taken; destination of the sample container before the sample is taken; sample container type and identity before the sample is taken; sta tus of associated analytical order for the sample before the sample is taken;

(ii) taking a subject's sample and subsequently registering one or more of the parameter values(s): time of sample taking; centrifugation status of the sample; filling volume of the sample container; time of departure of sample from the sample collection site; time of arrival of sample at an analytic site; shaking or commotion of the sample between time of sample taking and time of arrival at the analytic site; and

(iii) processing, storing and optionally transmitting said parameters; wherein said parameter value(s) is/are registered, processed, stored and optionally transmitted by a sample-container-like-sensor-and-interaction tube, which is brought into physical vicinity of the sample container before sample taking and kept in physical vicinity of the sample container during the pre-analytical phase, preferably until arrival at the analytic site.

[0011] This method advantageously allows to move forward to an earlier date sample registration steps and to prepare monitoring the status and condition of a sample at the earliest possible point in time, i.e. before the sample is taken. This close and efficient registration and controlling approach provides a solution with respect to the handling, transport and arrival of samples with uncontrolled quality in the laboratory, the problem of an arrival of an unknown number of samples at an unpredicted time point in the la boratory. Furthermore, sample history and verification of patient, collection site and phlebotomist identification becomes possible and thus allows for a secure, well docu mented and traceable quality assurance approach for samples, e.g. liquid samples. The present invention thus provides the means and methods for a digital, automated and seamless and highly efficient sample quality control and surveillance starting before sample collection up to lab analysis. The presently claimed and herein described tech nology accordingly raises the safety, quality, auditability and traceability of samples such as blood samples to an unprecedented level. The managing and integration of pre-ana- lytic values of patient samples and their further integration with patients' personal data, testing information, transport monitoring information etc. drastically reduces the risk of incorrect clinical data due to improper handling, mislabeling or other pre-analytical er rors and improves compliance with regulatory requirements, e.g. pursuant to ISO 15189:2012. More importantly, it drastically reduces the overall time of sample pro cessing and testing, precisely from time of sample taking until delivery of test results back to the medical doctor, since upon arrival at the laboratory essential information is already available and can directly and/or predictively be used for manual or fully-auto- mated sorting or sample processing and testing decisions. It also drastically reduces costs for performing laboratory tests by reducing manual efforts and accordingly re duces personnel costs, e.g. for manual troubleshooting at laboratory entry. It also re duces costs due to the optimized consumption of testing reagents for performing bio chemical assays, and due to an optimization of laboratory analyzer utilization and down- time due to maintenance or sample and reagent loading. Finally, also the number of avoidable and unsuccessful test due to poor sample quality is significantly decreased.

[0012] In a preferred embodiment, the parameter health condition of a subject com prises sobriety, pregnancy, blood pressure or wherein a free text note regarding the health status of a subject is provided.

[0013] In a further preferred embodiment said sample container is provided with an identifier such as a specific barcode or QR code which is initially present on the sample container or is attached to the sample container after sample taking.

[0014] In a further preferred embodiment said identifier comprises encoded infor- mation relating to at least one selected from the group: manufacturer, manufacture time stamp, use period, batch number, sample container type and article number or wherein said identifier is linked to a central or cloud-based database containing at least one information item selected from the group: manufacturer, manufacture time stamp, use period, batch number, sample container type and article number. [0015] In another preferred embodiment said parameter value(s) are registered on the sample-container-like-sensor-and-interaction tube and/or independently on a remote computer server system. It is particularly preferred that said parameter value(s) are reg istered on a cloud-based computer server system.

[0016] In another preferred embodiment, said registration is performed in a registration scanning device for sample containers and/or in a mobile phone or tablet application or a web-browser based scanning application.

[0017] It is further preferred that the registration additionally comprises one or more of (i) registration and verification of a phlebotomist to a program which is linked to the registration scanning device for sample containers, preferably in an a mobile phone or tablet application or web-browser based scanning application; (ii) registration and iden tification of the subject via the subject's hospital bracelet; (iii) registration of the subject via a patient file identification number; (iv) registration of the subject via an informed consent identification number; (v) registration of the subject via biometric data; or (v) registration of the subject via a wearable, preferably a smart watch or smart bracelet, (vi) registration of the subject via mobile phone or tablet authentication, preferably via a customer authentication application such as scanning of a provided barcode, QR code or image, or (viii) registration of a person transporting the sample container(s).

[0018] In a further preferred embodiment the registration and identification of the sub ject via the subject's hospital bracelet leads to a subject specific request for a test order in the laboratory. The information derived from the bracelet may accordingly be linked to additional data which allow for corresponding automatized decision making.

[0019] According to another preferred embodiment of the method of the present in vention, the registration via biometric data comprises one or more of (i) face scan, pref erably via a mobile phone or tablet; (ii) fingerprint scan, preferably via a mobile phone or tablet; (iii) scan of a passport or ID card; (iv) scan of an insurance card; (v) scan of a driver's licence; and (vi) scan of a photo ID card.

[0020] It is particularly preferred that the sample container-like-sensor-and-interaction tube is virtually linked to the one or more sample container(s) in its physical vicinity, wherein said virtual linkage comprises the recording of sample container information items and parameter values by the sensor-and-interaction tube. [0021] In another preferred embodiment of the present invention the recording and virtual linkage is initiated in an automatic or semi-automatic manner via contactless communication between the sensor-and-interaction tube and a registration scanning device for sample containers, preferably a mobile phone or tablet application or web- browser based scanning application. [0022] It is particularly preferred that the contactless communication is performed via

RFID (radio frequency identification), Bluetooth interaction, GSM, LTE, G5, LPWAN, Lo- RaWAN, or WiFi, preferably Bluetooth. [0023] In yet another embodiment, the recorded information items, parameter values and the virtual linkage data are transmitted to a remote computer server system, pref erably a cloud-based computer server system, or to a mobile data device, preferably a mobile phone or tablet application. [0024] In a particular embodiment of the present invention, said sensor-and-interaction tube records said one or more parameter values(s) in the physical vicinity of the sample container during the entire phase between the first registration before a sample is taken and the arrival at the analytic site.

[0025] In a specific embodiment said recording is performed after predetermined inter- vals, preferably every 0.1, 1 or 30 sec, or 1, 2, 3, 4, 5, 10, 20, 30 or 60 min, or wherein said recording is event-triggered, preferably by a shock or motion event.

[0026] In a further preferred embodiment the method comprises the additional step of delivering one or more, preferably all parameter values recorded during the registration, collection and transportation step with said sample container-like-sensor-and-interac- tion-tube to a data interface of a mobile phone or tablet application and/or at the ana lytic site via contactless communication.

[0027] In preferred embodiment of the method according to the present invention said said delivering of one or more, preferably all parameter to a mobile phone or tablet application and/or to the analytic site is performed during sample transport. [0028] In yet another preferred embodiment, said analytic site comprises a clinical in formation system such as a LIS system, a KIS system, a CPOE system, or a KAS system or a sample analyzer information technology unit connecting and controlling a plurality of sample processing and measuring analyzers, or an independent autonomously working sample analyzer unit. [0029] It is particularly preferred that said the received parameter values are integrated into the clinical information system and/or the sample analyzer system and/or the sam ple analyzer information technology unit connecting and controlling a plurality of sam ple processing and measuring analyzer. [0030] In a further preferred embodiment said parameter value integration is per formed via a cloud-based server system automatically, periodically or by request, pref erably 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

[0031] It is further particularly preferred that the LIS system, KIS system, CPOE system, or KAS system receives all parameter values from the sample-container-like-sensor-and- interaction tube and the barcode or QR code of a sample container via a cloud-based computer server system automatically or upon initiation.

[0032] In a another preferred embodiment, a recorded and delivered parameter value which surpasses or falls short of a predetermined threshold, which is associated to a sample container, results in an automatized separation of said sample container and/or an automatized alert of incoming goods or analytic personal and/ or the processing of samples in deviating manner from pre-programmed sample fate.

[0033] In a further preferred embodiment said processing in deviating manner com prises one or more of sorting the sample container, picking the sample container, plac- ing the sample container in a specific sequence, re-labelling of sample barcodes on the sample container or predictive labelling of aliquot containers, samples aliquoting or splitting or diluting or adding stabilization reagent, sample processing or sample meas urements in a re-arranged priority and sequence on sample analyzer units, and/or prep aration of or filling with reagent necessary for carrying out one or more biochemical assay.

[0034] In yet another preferred embodiment of the method of the present invention, said parameter value is provided in a digitalized form. [0035] In a further preferred embodiment, said barcode or QR code comprises remote database accessory data. Optionally, it may also comprise one or more of subject spe cific data, sample specific data and intended analysis-related data.

[0036] In yet another embodiment, said remote database accessory data provides a link to a database entry, wherein subject specific data, sample specific data and/or intended analysis-related data are registered.

BRIEF DESCRIPTION OF THE DRAWINGS

[00B7] Figure 1 provides an overview of some components of the method according to the present invention. Element A relates to the preparation of sample collection, start ing with doctor^'s decision including the activities of patient recruitment and prepara tion; selection of test, receiving and completing of order form (electronic Order En try/paper based order); collecting supplies e.g. choosing tubes, needles, print barcode, tube labeling; verification of nurse, Patient ID and patient^'s health status; and sample ID and tube type verification. Element B relates to the step of sample collection (blood draw) including locating the patient and collecting a sample; transfer of sample into a specific primary tube in a specific sequence; sample ID and tube type verification; and dispose of supplies. Element C relates to sample processing activities, including sample mixing, vortexing, cooling/ freezing; incubation, centrifugation, aliquoting; storage; and transfer of sample into a secondary transport container (e.g. a pneumatic tube, robot, courier box/bag). Element D relates to transport activities including pick-up of samples by courier, sending by mail/ pneumatic tube system, walk to the analytical site, sample logistics and transport monitoring. Element E relates to lab sample entry including or ganizing sample logistics and sample pick-up; sample ID registration and tube type veri fication; order verification, i.e. mapping sample ID with order ID; sample integrity check; sample sorting and separation; sending sample to appropriate lab department; and sam ple processing, splitting, relabeling, and preparation. Element F relates to sample analytics including sample quality check (e.g. serum/ hemolytic index); performance of sam- ple testing; and sample sorting and retesting. Element G relates to post analytics includ ing medical examination; analytical quality check; data reporting and data archiving to the medical doctor (dotted line) via paper-based or electronic reporting. Element H re lates to sample archiving including sample archiving for later additional test demands and sample rejection after appropriate timeframe.

[0038] Figures 2 shows embodiments of the process and data low according to specific embodiment of the present invention.

[0039] Figure 3 shows features of the sensor and interaction tube and sensor and inter action tube receiving station according to certain embodiments of the present inven tion. These features include data storage: with 30,000 measuring points and a redun dant ring buffer; electronics: with a definable sampling rate (e.g. 1 / min) and event trig gered, low energy Bluetooth (approx. 30 m range of the gateway); environmental sen sors: temperature sensor (-20 to + 50 ° C), gyro sensor (centrifugal force/camber); en ergy management: with battery life of approx. 350 working days and battery replaceable by a technician; and hygiene with: resistance to alcohol and/or formalin.

[0040] Figure 4 depicts features of a mobile application according to embodiments of the present invention.

[0041] Figure 5 depicts further features of a mobile application according to embodi ments of the present invention.

[0042] Figure 6 shows transport data providing an individual sample history according to a specific embodiment of the present invention.

[0043] Figure 7 provides an analytics summary of pre-analytical quality data according to an embodiment of the present invention.

[0044] Figure 8 shows LIS integration of the process according to an embodiment of the present invention. [0045] Figure 9 shows further features of a mobile application according to embodi ments of the present invention.

[0046] Figure 10 depicts further features of a mobile application according to embodi ments of the present invention.

DETAILED DESCRIPTION OF THE EMBODIMENTS

[0047] Although the present invention will be described with respect to particular em bodiments, this description is not to be construed in a limiting sense.

[0048] Before describing in detail exemplary embodiments of the present invention, definitions important for understanding the present invention are given.

[0049] 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.

[0050] 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 %.

[0051] 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.

[0052] 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.

[0053] It is to be understood that this invention is not limited to the particular method ology, apparatus, components, units, protocols, reagents, etc. described herein as these may vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the scope of the present invention that will be limited only by the appended claims. Unless defined oth erwise, all technical and scientific terms used herein have the same meanings as com monly understood by one of ordinary skill in the art. For the purpose of the present invention, all references cited herein are incorporated by reference in their entireties.

[0054] Moreover, the following embodiments can, wherever this does not lead to logi cal contradictions, be combined with each other without restrictions. Hence, the present disclosure encompasses, even where not explicitly spelled out in the following, any fea sible combination of the embodiments described below. Furthermore, the present dis closure encompasses, wherever this does not lead to logical contradictions, the combi nation of any of the embodiments relating to one aspect of the present invention with the other aspects of the present invention described herein.

[0055] As has been set out above, the present invention concerns in one aspect a sam pling method for taking a subject's liquid sample and for obtaining, processing, storing and optionally transmitting pre-analytical values for sample parameters or sample-as sociated parameters. It comprises three main steps: [0056] (i) Registering one or more parameter values(s) before a sample is taken. This step generally prepares the subsequent steps and completes registration activities con cerning the patient, the collection site, the test to be performed, the environmental conditions, the identity of the persons involved in the sample taking, the planned transport details and further steps which do not require a liquid sample to be present. By performing and, at least partially, finishing these early registration steps, it is advan tageously possible to reduce the time period of sample processing and registration after it has bee taken. It further allows for an immediate control and monitoring, e.g. within 1 to BO seconds, of sample associated parameter after the sample taking has been per- formed. Traditional non-observance time periods after sample taking are hence very ef ficiently prevented.

[0057] The sample parameter or sample-associated parameters values which are regis tered at a sample collection site before the sample is taken include at least one or more, e.g. 2, 3, 4, 5, 6, 7, 8, 9 or all, or any combination, of: - identity of the subject; the subject's personal data; health condition of subject; identity and location of the sample collection site; identity of the person drawing the subject's sample (phlebotomist); - sample type; intended test for sample; destination of the sample container; sample container type and identity; and status of associated analytical order for the sample. [0058] (ii) Taking a subject's sample and subsequently registering one or more addi tional parameter values(s). The sample taking procedure per se follows any suitable protocol as known to the skilled person, e.g. to a phlebotomist. Subsequently, i.e. once the sample has been taken and entered into a sample container, e.g. within a short pe riod of time of e.g. 1 second to 5 minutes, preferably within about 1 to 60 seconds af ter the sample has been taken and entered into a sample container additional parame ters may be registered. These additional parameters concern the sample itself or de tails of the sample taking which are only available once the sample actually been taken.

[0059] These sample parameter or sample-associated parameters values which are reg istered at a sample collection site after the sample is taken include at least one or more, e.g. 2 or all, or any combination, of: time of sample taking; filling volume of the sample container; centrifugation status of the sample.

[0060] Further sample parameter or sample-associated parameters may be registered subsequent to the sample taking, but do not require an immediate activity. These pa rameters are typically connected with sample or sample container transport activities. The parameters are preferably taken upon occurrence of event or in a repeated manner during an activity.

[0061] These sample parameter or sample-associated parameters values which are reg istered afterthe sample is taken and up to the arrival at the sample's destination include at least one or more, e.g. 2 or all, or any combination, of: time of departure of sample from the sample collection site; time of arrival of sample at an analytic site; shaking or commotion of the sample between time of sample taking and time of arrival at the analytic site.

[0062] (iii) Processing, storing and optionally transmitting said parameters parameter values(s). The processing, storing and transmitting of said parameters is advantageously performed with an information logger device, i.e. a sample-container-like-sensor-and- interaction tube. This device is capable of connecting itself or being connected with suit able registration scanning devices and/or a mobile phone or tablet applications or web- browser based scanning applications. It is further designed to register and store the pa rameters mentioned, e.g. by using suitable sensors or measurement units. The corre sponding values may further be processed, combined, analysed, compared etc. within the device, e.g. using a suitable microprocessor. Processed and/or stored parameter val ues or, alternatively, unprocessed raw data may further be transmitted, for example, to a remote computer server or database. The sample-container-like-sensor-and-interac- tion tube is advantageously brought into physical vicinity of the sample container to be used for the sample taking. This is already done or finished before sample taking has started so that the sample-container-like-sensor-and-interaction tube starts registering parameter values before a sample has been taken and entered into a sample container, as well as immediately afterwards. The sample-container-like-sensor-and-interaction tube is further kept in physical vicinity of the sample container during subsequent steps, preferably until arrival at the analytic site. Once, or in some embodiment before, the sample-container-like-sensor-and-interaction tube has arrived at the at the analytic site together with the samples or sample containers, registered parameter values are trans mitted to a clinical or laboratory information system or any other computerized device dealing with further sample processing steps at the sample's destination, e.g. a labora tory analyzer software, or a software controlling a plurality of laboratory sample pro cessing and analysing devices, or to a laboratory operator or laboratory technician.

[0063] As used herein, a "sample container" may 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. It is preferred that a liquid sample container is used. 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 embodiments be completely empty before a sample is filled in. It is particularly preferred that the container is sterile. In further embodiments the container may be provided in a form or design to allow forthe generation of vacuum in the container after filling.

[0064] The sample container may be composed of any suitable material. Typically, the container may be composed of glass or plastic material, or a combination thereof. Also envisaged is the use of metals and/or electronic components, e.g. integrated into the container. The material and form of the container may further be adjusted to specific local, regional, national or international regulations as to its properties, size, form etc.

[0065] For example, the container may comprise, before any sample is filled in, a rea gent or compound. For example, the container may comprise a stabilizing agent, which assists in preserving the sample. In further embodiments, the container may comprise reagents necessary for carrying out one or more biochemical assay(s) such as a buffer, nucleotides, an enzyme, a dye, etc. In yet another embodiment, the container may com prise 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 identifia ble particle may be provided in the container. These elements can either be filled in before the sample is added, or together with the sample or after the sample has been filled in. The sample container may further be chemically inert, e.g. composed of chem ically inert plastics material. In a further embodiment, the container may be provided as insulated container designed to keep the sample at a predefined temperature range and avoiding a freezing or cooking of the sample. In specific embodiments, the present in vention 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 below. 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, stor age, the number of assays planned with the sample, etc. Typically, sizes in the range from 1 ml to 50 ml are envisaged, e.g. 1 ml, 2 ml, 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 embodiments, also sizes smaller than 5 ml or larger than 50 ml are envisaged.

[0066] In a preferred embodiment, the sample container is a blood or processed blood collection container. Accordingly, the sample container is designed to fulfil all necessary regulatory requirements for blood transport, storage and/or diagnosis. The container may further be designed to alternatively comprise parts of a blood sample or a pro cessed blood sample, e.g. a plasma or serum sample. In a further preferred embodi ment, the sample container is a biopsy collection tube. Accordingly, the sample con- tainer 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. In a further group of embodiments, the sample container is a container or tube designed to receive a swab or smear, e.g. from a subject's oral cavity or throat. Accordingly, the sample container is designed to fulfil all necessary regulatory requirements for transport, storage and/or diagnosis of a swab or smear. The present invention further envisages the collection and transport of any other biological, medical or chemical sample type, e.g. water samples from environmental tests, microbial or virological samples from environmental or epi demiological tests, scientific samples to be provided to remotely locate working groups, geological samples, archeological samples, etc.

[0067] The "sample" to be taken may be any suitable biological sample. It is preferred that the sample is a liquid sample, e.g. a biological fluid such as urine, semen, sweat, sputum, saliva, feces, stool or a tissue samples. It is particularly preferred that the sam ple is blood, e.g. full blood, or processed blood. The sample may, for example, be a plasma or serum sample or a full blood sample pre-analytically processed, e.g. by the addition of stabilizing reagents, heating, cooling, freezing, centrifugation or it may be storage light protected or the like.

[0068] In preferred embodiments, the sample container comprises an identifier, prefer ably a scannable or registrable identifier. Examples of envisaged identifiers include a barcode, a matrix code, a QR code, a PC code, EAN code, EANUCC code, CODABAR code, CODE 39 code, CODE 128 code, Interleaved 2/5 code, Discrete 2/5 code, Postnet code, BPO code, CODE 49 code, CODE 16K code, PDF417 code, AZTEC code, DATAMATRIX code or MAXICODE code. Further envisaged are electronic codes such as flash memory, EPROM or EEPROM. In certain embodiments, an RFID or NFC component or tag may be integrated into the identifier, e.g. the barcode or matrix code. For example, the barcode, matrix code or QR code or any of the other above mentioned codes may be provided in the form of a sticker or an adhesive label on the surface of the sample container. It is further envisaged that said identifier is already pre-printed or pre-arranged on said sam ple container. In this embodiment, the code may encode information on the individual sample container such as the identity or name and/or address of the manufacturer, a manufacture time stamp, information on the possible use period, a batch number, in formation on the sample container type, on the sample container filling volume, the production site, an unique medical device identifier (UDI) and an article number or the like. In yet another embodiment the identifier may comprise a link or additionally com prise a link to a central or cloud-based database. The database may contain at least one information item selected from the group: the identity or name and/or address of the manufacturer, a manufacture time stamp, information on the possible use period, a batch number, information on the sample container type, on the sample container filling volume, the production site, an unique medical device identifier (UDI) and an article number or the like. By activating the link, a virtual linkage between the database and the sample contain can be established. This virtual linkage may further be used for the transmission and delivery of additional data to the database or from the database to a connected device involved in the processing of the sample or sample container. In a specific embodiment the database may be or may be connected to a manufacturer's central database or another suitable central database for medical devices. In further preferred embodiments, the identifier may further comprise remote database accessory data. The remote database accessory data may, for example, provide a permission link to a database entry, wherein subject specific data, sample specific data and/or intended analysis-related data are pre-registered. The identifier may, in certain embodiments, also comprise one or more of subject specific data, sample specific data and intended analysis-related data.

[0069] By scanning an identifier a link to a database as defined above, or a direct trans mission of the encoded data to the scanning device can be initiated.

[0070] As outlined above, the method of the present invention centrally and advanta geously envisages the use and presence of a "sample-container-like-sensor-and-inter- action tube" or abbreviated "sensor-and-interaction tube". This tube is typically brought and kept in physical vicinity of the sample container during the pre-analytical phase, e.g. up to arrival at the sample's final destination such as a laboratory. Advanta geously, the employment of the sensor-and-interaction tube allows for the detection, recording and registration, as well transfer of data and parameter values associated with the sample and with the sample container as well as with parameter values asso ciated with the sample taking and transport itself. The "sample-container-like sensor- and interaction tube" as used herein relates to a receptacle which has a similar or iden tical form as the sample container described herein, but is not capable of comprising and storing a biological or medical sample. In certain embodiments, the sample-con- tainer-like-sensor-and-interaction tube may have a different size, e.g. smaller or bigger size and/or different form as the sample container.

[0071] According to the invention, the sensor and interaction tube, instead of compris ing a sample, is equipped with suitable units, sensors and modules to allow for the re cording, detection, registration and transmittal functions described herein. [0072] According to embodiments of the invention, the sensor-and-interaction-tube is equipped, for example, with a unit for contactless communication with a base station. A "base station" in the context of the contactless communication means any interacting entity outside of the sensor and interaction tube. In some embodiments, the base sta- tion is a registration scanning device, e.g. in a hospital or medical practice, i.e. a location where sample containers are filled with subject samples. Alternatively or additionally, a laboratory information system or laboratory information management system may work as base station. Preferably, the laboratory information system may be connected to a gateway device in the sample container incoming department. The gateway device may be equipped with contactless communication means, e.g. Bluetooth functionality, which allows to interact with incoming sensor and interaction tubes as defined herein. In specific embodiments. In further embodiments, the base station may be a mobile de vice such as a mobile phone or tablet. This mobile device is capable of interacting with the sensor-and-interaction-tube, e.g. via contactless communication means such as Bluetooth. In further embodiment, the base station may be any device which is equipped with a contactless communication means, preferably a Bluetooth functionality and which is capable of receiving data from the sample container, e.g. via scanning of identifiers such as barcodes or QR codes. Examples of such additional devices include handheld scanners, or mobile phones or table computers comprising a scanning appli- cation.

[0073] The term "unit for contactless communication" relates to an electronic or com puterized element, which either actively sends out a signal to a base station or works passively and may react to a signal generated by a base station. In both scenarios, the signal may be transmitted without direct physical contact between the sample con- tainer-like sensor and interaction tube and a base station, e.g. via radio waves.

[0074] In a preferred embodiment, the unit for contactless communication is based on Bluetooth technology. Bluetooth is a wireless technology standard for exchanging data over short distances using short-wavelength ultra-high frequency (UHF) radio waves in the industrial, scientific and medical (ISM) radio band from 2.400 to 2.485 GHz from fixed and mobile devices, and a building personal area networks (PANs).

[0075] In preferred embodiments the unit may be configured for data transmission such as an RFID unit, an NFC unit, a GSM, LTE or G5 unit, a LPWAN unit, a LoRaWAN unit, a Bluetooth unit or a WiFi unit as defined herein.

[0076] The unit for contactless communication may in certain embodiments, also be based on high-speed wireless communication standards such as G5, LTE (long-term evo lution), or GSM/EDGE or UMTS/HSPA technologies, or any other suitable high-speed wireless communication technology or standard, e.g. also technologies which will be de- veloped in the future, or are not yet commercially available such successors of G5 etc. It is preferred that the communication module allows for real-time communication with a remote receiving station.

[0077] The unit for contactless communication may, in further embodiments, be a WiFi or WLAN module for local data transfer in a surrounding which provides suitable receiv- ing possibilities. In alternative embodiments, the unit may be capable, or may addition ally 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 tech nology standard developed to enable a wide range of devices and services to be con nected using cellular telecommunications bands. NB-loT is a narrowband radio technol- ogy typically designed for the Internet of Things (loT) and is one of a range of Mobile loT (MloT) technologies standardized by the 3rd Generation Partnership Project (3GPP). The present invention further envisages the use of similar technologies such as eMTC (en hanced Machine-Type Communication) and EC-GSM-loT. In further embodiments, the unit for contactless communication may be a Long Range Wide Area Network (Lo- RaWAN) module. LoRa is a LPWAN protocol, which enables long-range transmissions, e.g. 10 km or more, with low power consumption. [0078] According to further embodiments of the invention, the sensor and interaction tube is additionally or alternatively equipped with a unit for the measurement of tem perature such as an electronic temperature sensor. The unit is designed to measure the temperature in the physical vicinity of the sample-container-like sensor-and-interaction tube and thus, if the sample-container-like sensor-and-interaction tube is kept in physi cal vicinity of one or more sample container, also in the physical vicinity of said sample containers and corresponding samples. The sample-container-like sensor-and-interac- tion tube and the sample containers, may, for example, be together in a box, bag, en velop, parcel or any other means of transport and compilation. Since the temperature within a close physical vicinity, e.g. in a common box, bag, envelop etc. is assumed to be identical or highly similar for all items in physical vicinity, i.e. for the sample-container- like sensor-and-interaction tube and the sample containers and the comprised samples, the measured temperature is taken as representative for the temperature of all sample containers and corresponding samples grouped with the sample-container-like sensor- and-interaction tube. The present invention thus envisages a specific method step which measures the temperature with a sensor as described above.

[0079] According to further embodiments of the invention, the sample-container-like sensor-and-interaction tube is additionally or alternatively equipped with a unit for the measurement of shaking and commotion. The unit may, for example, be capable of de termining vibrations and and/or centrifugal forces and/or gravitational changes exerted on the tube, e.g. due to pressure changes, downfalls, fast horizontal or vertical move ments etc. An example of a suitable sensor is a piezoelectric device. Since the vibrational conditions within a close physical vicinity, e.g. in a common box, bag, envelop etc. is assumed to be identical or highly similar for all items in physical vicinity, i.e. for the sam- ple-container-like sensor-and-interaction tube and for the sample containers and the corresponding samples, the measured vibrational parameter is taken as representative for the shaking and commotion parameter of all sample containers and corresponding samples grouped with the sample-container-like sensor-and-interaction tube .The pre sent invention accordingly envisages a specific method step which measures the com motion or vibration with a sensor as described above.

[0080] According to further specific embodiments of the invention, the sample-con- tainer-like sensor-and-interaction tube may additionally or alternatively equipped with a unit for the measurement of humidity. The unit may, for example, be capable of de termining humidity in the physical vicinity of the tube. An example of a suitable sensor is a dry nitrogen based sensor. Since the humidity conditions within a close physical vi cinity, e.g. in a common box, bag, envelop etc. is assumed to be identical or highly similar for all items in physical vicinity, i.e. for the sample-container-like sensor-and-interaction tube and for the sample containers, the measured humidity parameter is taken as rep resentative for the humidity parameter of all sample containers grouped with the sensor and interaction tube. The present invention accordingly envisages a specific method step which measures humidity with a unit as described above.

[0081] According to further embodiments of the invention, the sample-container-like sensor-and-interaction tube is additionally or alternatively equipped with a chronome ter unit, which is preferably connected to one, more or all of the units present in said tube, thus allowing for the determination and registration of parameters associated with time, e.g. allowing for a periodic or event-triggered (e.g. shock or commotion trig gered) measurement of certain parameters, as well as the provision of time stamps for certain events or incidents. This unit further allows for the provision of time stamps upon occurrence of certain events. These events may be registered by the sample-con- tainer-like sensor-and-interaction tube itself or be provided to it via transmittal from a remote computer server or database or a base station as defined herein.

[0082] According to embodiments of the invention, the sample-container-like sensor- and-interaction tube is further equipped with a data storage and management unit. This unit is designed to receive, store and provide data and information on one or more pa rameters associated with a sample container to be transported together with the tube. The unit may, for example, receive, store, process, compare, manipulate or provide any parameter value received with any of the above described units, sensors or modules or received from a remote computer server or database or a base station as defined herein. The unit further preferably receives, stores and provides data concerning time stamps, e.g. time points of registration at a sample collection site as mentioned above, the iden tity of the subject whose sample is collected and filled into the sample container, the identity of the person drawing the subject's sample, the time of departure from the sample collection site, the identity of the person transporting the sample containers, e.g. a courier, the time of arrival at an analytic site and storage time at the analytic site or other information as mentioned herein.

[008B] The present method envisages the acquirement and managing of values for one or several parameters of pre-analytic importance via the physical and virtual linkage of one or more sample containers and a sample container-like sensor and interaction tube as defined herein above. The sample container-like sensor and interaction tube essen tially works as reception, integration, transport and provision tool for all pre-analytic steps up to the delivery of the sample container to an analytic site. The method accord ingly requires at least two different types of activity or input for the sample container like sensor and interaction tube, namely input as to measurable events during the pre- analytic steps such as vibrations, temperature changes etc., and input as to the specific information items connected to each of the sample containers. Said information items are, according to the present invention, not provided directly within the sample con tainer, but may be associated to it via the sample-container-like-sensor-and-interaction tube, which operates as a chaperone for said sample containers. In certain embodi ments, parameter value(s) is/are obtained and subsequently processed or managed at a remote location, e.g. in a cloud-based server. The acquirement of data is accordingly followed by a transmission of received data to said remote location, where further pro cessing or managing operations, e.g. recording, virtual linkage, comparison steps, and optionally retransmission steps into the sensor and interaction tube are performed. In preferred embodiment, the reception, integration, transport and provision is performed in the sensor and interaction tube with a remote-server, e.g. cloud-based server system as mirror and secondary managing or integration unit.

[0084] In an embodiment of the invention the time of registration of a subject at a sam ple collection site may include information on current and previous registration events, time periods between registrations, information on repeated registration within a cer tain time period such as a day, a week, a month etc.

[0085] In a further embodiment of the invention the identity of the subject may be reg istered via an individual identifying number, or an official document such as a health insurance card, identity card, driver's licence etc.

[0086] In a further embodiment of the invention the personal data of the subject whose sample is to be analysed may include name, date of birth, address and telephone num ber, email or secondary information such as name and address or the subject's medical doctor, associated hospital or remitting person.

[0087] In a further embodiment of the invention the health condition of subject may be registered. This may include information on the sobriety status, i.e. has the subject eaten or drunk anything, in case of female subjects whether the subject is pregnant, or infor mation on the blood pressure. Further, there may be a free text note option regarding any other relevant information on the health status of a subject.

[0088] In a further embodiment of the invention the identity and location of the sample collection site may include hospital, practice or institution name, street address, tele phone number, email or secondary information such as name of contact person, acces sible entrances, parking possibilities in the vicinity, opening and closing hours, entry re quirements etc. or of any other place where the sample was taken The information may further be connected to or integrated with electronic map data, e.g. Google map data. This information may advantageously be used for the planning and performance of cou rier and delivery activities, e.g. using an Al-based sample collecting planning which re quires information on the location and accessibility of the sample collection site. [0089] In an embodiment of the invention the phlebotomises personal data may include the name, address, telephone number etc. of the medical practitioner, nurse or other person who was drawing the sample. It may also include a previous working history, in indication of previously taken similar or identical samples etc.

[0090] In a further embodiment of the invention information on the intended test for the sample may be registered in the form of a selection from a group of offered or sug gested tests, e.g. a laboratory test for typical blood analytes, ion or protein concentra tion, presence or absence of cells or specific cell types in the sample, enzyme activities or analysis of appropriate biomarkers (e.g. Troponin-T) to assess the health status of the patient as basis for diagnostic decision making. Further, information on the status of an associated analytical order for the sample may be registered. This may include specific information on the test to be performed as received from the subject's attending doctor or nurse. It may further include additional information on changes of the order, e.g. de letions of previously intended tests or additions of further tests, which were previously not planned etc. In a particularly preferred embodiment, information on the urgency of an order may be registered. This may also include information on the expected or re quested time of accomplishment of a test.

[0091] In a further embodiment of the invention registration of the sample container type may include registration of information on the container size, form, weight, its ma terial, suitability for the ordered analysis etc. It may further include information on the manufacturer, a manufacture time stamp, the use period of the sample container, a production batch number or an article number. Further, the sample container identity may be registered based on a number, an identifier or code such as a barcode or QR code. This identity number or code is preferably unique for each sample container and helps to clearly identify and avoid mixing-up containers. This sample container identity is preferably used as one key information item within a database or data warehouse structure to retrieve and organize further data on the sample and/or patient associated etc. [0092] In a further embodiment of the invention the destination of the sample container may be registered by the street address, name and telephone number or email address of the laboratory or analytic site to which the samples are transported or where the sample is to be analysed and/ or the destination may be linked to specific transport con- dition, preferably, room temperature, cooled or frozen.

[0093] In a further embodiment of the invention the place and time of collection of the sample may be registered. This may include the registration of the place via GPS coordi nates or other suitable electronic map information. The time stamp may further include an indication of the time zone or information on the maximum time period fortransport according to regulatory or internal requirements.

[0094] In a further embodiment of the invention information on the centrifugation sta tus of the sample may be registered, e.g. after a centrifugation has been performed. This may include data on the centrifugation time and force, the used centrifuge, the temper ature during the centrifugation etc. It may also be registered if no centrifugation was performed.

[0095] In a further embodiment of the invention the filling volume of the sample con tainer may be registered indicating, for example, whether the sample container is en tirely filled or whether the filling status is at least partially empty. Further parameters include the presence of a solid / liquid phase in the container and the presence of a gel layer.

[0096] In a further embodiment of the invention the time of departure of the sample from the sample collection site is registered, e.g. via a time stamp. This time point may be obtained via the registration of a change in the sample's location, e.g. via a GPS tracker present in the sample-container-like-sensor-and-interaction tube, or via manual input into a device from a courier or transporting person, or via Barcode/ QR code, Blue tooth or RFID interaction at the collection site registering that the sample-container- like-sensor-and-interaction tube has left its previous location. [0097] In a further embodiment of the invention the identity of the person transporting the sample containers, e.g. a courier, is registered. The corresponding information may be linked to personal data of the courier, and/or location data, e.g. allowing for the se lection of a courier who is closest to the collection site, or whose collection route is most efficient and/or allows for the earliest delivery of the samples to the analytic site.

[0098] In a further embodiment of the invention information on the shaking or commo tion of the sample between time of sample taking and time of arrival at the analytic site may include data on time and duration of the commotion, or the location where the commotion took place.

[0099] In further embodiments of the invention additional parameters may be regis tered such as the barcode readability of the sample container, the humidity of the sam ple containers, the light or heat exposure of the sample containers, deviations from prognosticated travel and transport times or routes or the like.

[0100] The herein described information parameter values or items are preferably re ceived, stored, transported and provided at the earliest registration event up to the ar rival to an analytic site.

[0101] According to the present invention, the parameter values or items are registered at a registration scanning device. The term "registration scanning device" as used herein relates to an apparatus which is capable of providing at least a scanning functionality of a code, e.g. barcode or QR code on a sample container and a connectivity functionality to a sensor and interaction tube as described above. In certain embodiments, the regis tration scanning device may further have a connectivity functionality to a remote com puter server system, as well as one or more additional accessory functions or modules, preferably a cloud-based computer system.

[0102] In preferred embodiment, the registration scanning device may comprise one or more of the following: (i) A scanning module, which is capable or receiving information from a sample con tainer, preferably barcode or QE code information provided on the sample container. The scanning module may further be capable of determining the color or the sample container cap. The scanning module may further be capable of determining the form of the sample container, its size and its filling status, e.g. whether a certain filling level is or is not reached, whether a solid / liquid phase is present in the container, whether a gel layer is present, which centrifugation status the sample has. In further preferred em bodiments, the module is also capable of scanning a subject's hospital bracelet, e.g. a barcode, number or QR code present on said hospital bracelet.

(ii) An acoustic input and/or output module. This module may serve as signaling center for the registration scanning device informing, for example, about an accepted scanning, e.g. if the barcode or QR code could be registered completely, or about an abnormal status of samples in the sample container. The alerts may be conveyed in form of alarm tones. The module may be configured to provide a direct acoustic alarm at the device, or it may be configured to send an acoustic alarm signal to connected devices such as a handheld device, smartphone or the like. The acoustic imodule further comprises a switch or similar element which allows to terminate the alarm, e.g. after the cause of the alarm has been eliminated, or independent of such an elimination.

(iii) A unit for linkage to a patient file or patient order, a patient file identification num ber, an informed content identification number etc. It is typically configured for data transmission. Also envisaged is the connection to a patient order with respect to anal yses to be performed.

(iv) A unit for registration and verification of the phlebotomist to a program which is linked to the registration scanning device. This unit is envisaged as checkpoint module allowing to document and register the identity of the operator responsible for the sam ple container processing during and after sample drawing. (v) A unit for linkage to a subject wearable, configured for data transmission. This unit may, for example, be configured to connect automatically to a smart watch, a smart bracelet or other type of wearable of a subject, or, in certain embodiment, to a subject's hospital bracelet if this is provided with smart wearable technology. It may download any suitable information from said wearable, e.g. for patient verification purposes or for purposes of determining suitable analytic tests etc. or whether additional analysis steps or activities are required, whether further and/or different samples are required from a subject. The information derivable from a subject's wearable may include, for example, the subject's identity, the subject's pulse, the subject's blood pressure, the subject's car- diac rhythm, the subject's blood glucose level, the subject's oxygen supply and/or the subject's stress status. These parameters are preferably determined in a predefined pe riod of time, more preferably directly before, during or after the sample is taken. In a case a predefined limit or range or corridor in terms of a subject's pulse, the subject's blood pressure, the subject's cardiac rhythm, the subject's blood glucose level, the sub- ject's oxygen supply and/or the subject's stress status is surpassed or underrun, the cor responding sample may be marked as unusable. In such a scenario, a further, new sam ple may be requested or taken. For example, the information derived from a patient's wearable may be combined, integrated and/or compared with information obtained from a point of care unit. The term "wearable" as used herein, relates to a miniature electronic device that is worn under, with, or on top of clothing. Typically, a wearable may be a smartwatch which is used at the wrist. Other examples include devices which monitor the eye, e.g. in the form of contact lenses or smart glasses, or can be worn at different parts of the body. Also envisaged is the integration of wearables into clothing, e.g. shirts or trouser (intelligent textiles), on-chest devices or smart necklaces. Further envisaged are implantable devices, which provide patient's information including asso ciated with its location, e.g. under the skin.

(vi) A unit for linkage to a remote computer server system, e.g. a cloud-based computer system and/or a remote database system and/or a health information system config ured for data transmission and/or a mobile phone or tablet application. The term "health information system" as used herein, refers to a comprehensive, integrated in formation system designed to manage all the aspects of health related operations, such as medical, administrative, financial, and legal issues and the corresponding processing of services. The system typically provides a common source of information about a sub ject's health history. The system typically keeps data in a secure place and controls who can reach the data in certain circumstances. A linkage as envisaged herein may be based on suitable interfaces with said systems, e.g. a common data format or the like. Suitable software or hardware modules may accordingly be present in the device according to the present invention.

(vii) A unit for a subject's biometrics recognition, preferably of a subject's fingerprints or iris. The unit may, for example, be capable of scanning a fingerprint, or an eye of a sub ject or any other person, e.g. the phlebotomist. Also, a comparison with deposited data, e.g. in a database may be performed by this unit. In a further embodiment, the unit may be capable of face recognition or of reading implanted chips. In yet another group of embodiments, the unit may be capable of scanning or reading a passport, insurance card, driver's licence or photo ID of s subject or any other person.

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

(ix) A mobile phone, internet, intranet or app interface. This unit allows for connection of the device with suitable outside devices such as a mobile phone, a tablet, or an inter net program, a browser. Alternatively, also intranet interfaces may be used, e.g. in a hospital environment. In further embodiments, the connection may be performed via an App which is capable of showing one, more or all elements as shown on the display as mentioned herein above. In particularly preferred embodiments, the mobile phone, internet, intranet or App interface is capable of registering a subject, i.e. a patient whose sample is to be drawn, via a mobile or tablet authentication. The authentication process advantageously includes the scanning of a barcode or QR code or image or the like by the mobile phone or tablet application. Suitable examples for the authentication process are a paysafecard-like approach including the use of a scanner application on a device, e.g. a mobile phone or tablet, which allows to scan a barcode or QR code or image code presented, e.g. on a computer screen or mobile device, followed by an approval step. The interactions and software handling details may vary and preferably include estab lished mobile phone procedures such as fingerprint scans or iris scans or password input for authentication purposes. The present invention also envisages any further develop ment in this respect, e.g. further authentication methods and technologies which will be developed in the future.

(x) A machine learning and data processing unit. This unit is preferably configured to perform one or more of the following tasks: automatized evaluation of sample registration data and/or measured parameters, preferably of image data; automatized analysis of sample images taken during the registration steps by a device, e.g. a mobile phone application; autonomous calculation of key performance indicators (KPIs) or quality indicators obtained during one or more pre-analytic activities within or outside the device, preferably of the sample image analysis; autonomous generation of system or user feedback on the basis of calculated KPIs, e.g. feedback to phlebotomist with respect to detected errors, problems or deviations from predetermined standards or values with respect to KPIs or quality indicators; autonomous identification and marking of erroneous or defect samples and/or sample containers; and comparison of measured data or parameters with a data or parameters derived from a database, preferably an internal database. The unit may make use of suitable machine learning or Al algorithms known to the skilled person. For example neural networks such as CNNs or DCNNs may be used. The machine learning approach may preferably be based on image recognition algorithms. The machine learning and data processing unit may further be used for one or more additional the tasks such as the coverage of a laboratory order or a linkage to an order entry software or functionality at the lab site may be implemented. Additionally, or alternatively, a mapping with external orders or personal information of a subject, phlebotomist or courier may be performed. Accordingly, received data from the registration process may be compared with order or personal information etc., sample container type information, e.g. barcodes, QR codes, optionally also be verified with subject information. For example, the sample container type may be compared with the order, or the barcode may be compared with the order, or the patient identity may be compared with the order etc. Also envisaged is the check for completeness of the order or associated documents. Also, the mapping with internal databases may be performed. Such mapping procedure may include the connection of a sample container type with a centrifugation or filling volume requirement etc. The mapping may be performed with the scanning device, e.g. in a display unit, or it may be performed in a remote receiving station, e.g. a cloud-based server or an associated mobile phone application, or in a mobile phone or table application. The mapping may result in a feedback to the operator of the device or application. Also envisaged is the use and development of internal databases or of external databases at a remote place, e.g. a cloud-based server, wherein said databases are self-learning and autonomously optimizing based on pattern recognition of captured images or other parameters.

[0103] In a further embodiment of the present invention the registration of one or more of the herein above described parameter values may be performed in a mobile phone or tablet application. The mobile phone or tablet application may, for example, be used as scanning device for identifier such as barcodes, QR codes, or as entry device for per- sonal information, e.g. a subject or phlebotomist enters personal information such as name and address etc. In further embodiments, the mobile phone or tablet application, e.g. via a camera interface, is used to determine the filling volume of a sample container, the sample type, the container type, or the centrifugation status. Additional data may be introduced manually into the application, e.g. origin of sample, place and time of collection of the sample, destination of the sample container. In further embodiments, information received from the sample-container-like-sensor-and-interaction tube may be entered into the mobile phone or tablet application, e.g. via a remote computer server system, e.g. a cloud-based computer system and/or a remote database system and/or a health information system configured for data transmission or the like.

[0104] In a further embodiment of the present invention the registration of one or more of the herein above described parameter values may be performed with a web-browser based scanning application. This application may be connected to a scanning device and/or input tools such as a keyboard, eye scanner, barcode scanner, camera or the like. It may further be connected to a remote computer server system, e.g. a cloud-based computer system and/or a remote database system and/or a health information system configured for data transmission or the like, preferably via internet or intranet connec tivity.

[0105] The present invention envisages, e.g. on the basis of a registration scanning de vice or mobile phone or table application as described above, the registration of a set of data. For example, it is envisaged that the registration of data comprises:

(i) registration and verification of a phlebotomises to a program. The program may, for example, be linked to the registration scanning device for sample containers or to a mo bile phone or tablet application;

(ii) registration and identification of the subject via the subject's hospital bracelet;

(iii) registration of the subject via a patient file identification number;

(iv) registration of the subject via an informed consent identification number;

(v) registration of the subject via biometric data. The registration may preferably be per formed with a face scan a fingerprint scan, the scan of a passport or ID card, the scan of an insurance card, the scan of a driver's license or the scan of any other photo ID. (vi) registration of the subject via a wearable, e.g. as defined herein above, preferably a smart watch or smart bracelet,

(vii) registration of the subject via mobile phone or tablet authentication, preferably via a customer authentication application such as scanning of a provided barcode, QR code or image;

(viii) registration of a courier, i.e. a person transporting the sample container(s), via any of the registration options of (v), (vi) or (vii), or alternatively via password input.

[0106] In specific embodiments the registration of a subject according to the present invention may automatically trigger the calling of a next subject or patient (patient scheduling), e.g. in a phlebotomises waiting room or a hospital waiting zone. This pro cedure is assumed to shorten the time period required for sample taking and thus fur ther contributes to an overall time saving for pre-analytic steps.

[0107] The present invention further envisages that the sample-container-like-sensor- and-interaction tube is virtually linked to one or more sample container(s) in physical vicinity to the sensor and interaction tube. The term "virtual linked" or "virtual linkage" as used herein relates to a combination of data sets or information items. The linkage has the purpose of forming a transport and delivery group for sample containers, which is headed and whose parameter detection is managed and organized by the sensor and interaction tube. By physically accompanying the grouped together sample containers, only one sensor and interaction element for is necessary for the entire group. The virtual linkage is preferably performed by the sample-container-like-sensor-and-interaction tube which is connected to a registration scanning device or scanning mobile phone or tablet application or the like, capable of registering information of sample containers to be transported together with said sensor and interaction tube and/or pre-analytically processed. The linkage preferably comprises a recording of sample container infor mation, e.g. sample container identity, origin of the sample, place and time of collection of the sample, sample type, e.g. blood, serum, biopsy sample etc., container type, e.g. its size, form, weight, its material, suitability for the ordered analysis etc., destination of the sample container, filling volume of the sample container, presence of solid / liquid phase in the container and the presence of a gel layer, status of an associated analytical order for the sample, centrifugation status of the sample, barcode readability of the sample container as defined above. In further embodiments, the virtual linkage may also comprises a recording of personal data associated with the sample or the sample man aging, preferably, personal data of the subject whose sample is to be analysed, the phle botomises personal data, the identity of the person transporting the sample containers, e.g. a courier, or other parameters as mentioned herein above.

[0108] The virtual linkage is preferably a linkage which works for the pre-analytic pro cess starting with the first registration event. A preferred initiation point is when a sub ject is registered at a sample collection site before the sample is taken, or when a sample container is registered, e.g. scanned, in a registration scanning device as defined above, or in a mobile device application as described herein before it is filled with the sample. Once the sample containers have arrived at their destination, e.g. an analytic site, this virtual linkage may be terminated, allowing for a potential recycling of the sample-con- tainer-like-sensor-and-interaction tube for further transport procedures.

[0109] In further embodiments of the invention, the recorded information items, pa rameter values and the virtual linkage data are transmitted or delivered to a remote computer server system, preferably a cloud-based computer server system, or to a mo bile data device, preferably a mobile phone or tablet application. It is particularly pre ferred that the virtual linkage between the sample-container-like-sensor-and-interac- tion tube and the sample containers is mirrored in a cloud-based remote server or com puter system and/or in a mobile phone or table applications and/or in a LIS or LIS con nected system, e.g. a cloud-system connected to the LIS. The virtual linkage may, for example, be reflected in a connection of database entries in a database system, or the generation of information objects in a suitable warehouse structure. The present inven tion accordingly envisages that the environmental data of the sensor and interaction tube are entered into a database comprising data of the virtually linked blood sample. This advantageously allows to call up the environmental history of the real blood sam ple, e.g. once it becomes necessary, for documentation, statistical, quality management or error detection or other purposes. [0110] It is further envisaged that specific parameter values registered according to the present invention are virtually linked, preferably before a sample is taken. For example, parameters concerning the subject, the phlebotomist, the collection site location, the collection site identity, the sample container and the sample-container-like-sensor-and- interaction tube may be grouped and virtually linked. This may advantageously be per- formed before the sample is taken and filled into a sample container and before this sample container is brought into the vicinity of the sample-container-like-sensor-and- interaction tube. A further, additional virtual linkage may be performed one the sample is taken, e.g. including time of sampling and further parameters as mentioned above. It is further envisaged that certain steps may require a manual confirmation, e.g. an ac- ceptance in a program, a secondary scanning, the inputting a login or personal data item etc. A further virtual linkage may be provided before or upon the collection of the sam ple containers by a courier. This may include an integration of the sample associated parameters such as urgency of the request or expected time of accomplishment etc. Such an integration, which may include a connection to a courier service database or planning system may lead to a smart planning of transport and delivery activities, e.g. allowing for urgency dependency of the transport, the introduction of additional waiting periods if the number of samples to be transported is smaller than a predefined limit, or the acceleration of the collection of the samples by a courier if the number of samples to be transported is higher than a predefined limit or no more samples are linked within a specific timeframe (e.g. 60min) and no more samples are accepted to be collected at that day. The integration process may further include information from different collec tion sites, traffic information, courier driver availability information, distance infor mation and the like. It is preferred that the integration and virtual linkage is performed on-line or in a fast manner. Further elements include in the virtual linkage may include information on testing capabilities at the analytic site, e.g. information that more or less samples can be analysed, that the site or specific laboratory analyzer for specific re quested tests are out of service, that a different site has to be used due to technical reasons (e.g. analyzer maintenance, missing reagent for biochemical assays) etc.

[0111] The transmitted information may advantageously also include all, most or some of the parameters measured by the sensor-and-interaction tube during the transport and delivery period, e.g. shaking, e.g. vibrations, commotion, temperature, humidity, elapsed time between start and stop etc. as defined above. The transmitted information may additionally comprise personal data registered in the initial sample processing steps, e.g. personal data of the subject whose sample is processed, personal data of the phlebotomist and/or personal data of the courier etc. as mentioned above.

[0112] The term "remote computer server system" as used herein relates to a network based server system, preferably a database server, which is connected to one or more devices used for the registration, surveillance and delivery of the sample containers, i.e. a registration and scanning device, a sensor-and-interaction tube, a LIS system at an an alytic site or a connected gateway module, and mobile device with scanning functional ity. The present invention accordingly envisages an independent remote computer server system, which is connected in a wireless communication fashion with one or more of the mentioned component(s) of the present invention. In specific embodi ments, the remote receiving station may be connected to additional components such as hospital databases or computer server systems, national or international health da tabases or computer server systems, a device directly associated with a patient, e.g. a personal mobile device such as a smartphone or a tablet PC, or a wearable, a device which may be located at 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, or to a mobile device such as a smartphone, e.g. comprising an App which allows to monitor the transport of the sample containers/sample container. The connection between these components and the remote computer server system may be unidirectional, e.g. from the components to the remote computer server system or from the remote computer server system to the component, or it may be bi- or multidi rectional, allowing for a complete exchange of information, advantageously filtered ac cording to necessities and requirements, e.g. predefined information hierarchies or pri- ority lists, between all integrated elements. It is preferred that the remote computer server system works as a cloud-based computer server system or network-based server system. In a corresponding architecture, one component may be considered as a client, and a different component may be considered as a server. Each element may further comprise multiple systems, 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 physical server may further be distributed logically into two or more logical servers. Corresponding services are offered by several companies, including Amazon, Google, IBM and Microsoft. In a specific embodiment, the remote computer server system is designed to receive in a wireless and/or real-time communi cation fashion information or parameter values as described herein form the associated component(s). This information may be accumulated, filtered, organized, verified, com- pared with standard values, e.g. with the help of Al modules or algorithms as described herein and/or stored in the server, e.g. in a suitable database format. The information may, in further embodiments, be used for a decision making process and/or organiza tional decisions as to the fate and future of a specific sample container or sample, and/or as to potential further activities associated with a patient, e.g. additional sample taking etc. The information may further be used for quality management evaluation, e.g. by checking KPIs, e.g. with the assistance of machine learning or Al modules or algorithms as described herein. In further embodiments, all or some of these functions may be per formed by a mobile data device, e.g. a mobile phone or tablet device. [0113] According to specific embodiments the sensor-and-interaction tube as defined herein records one or more parameter values(s) comprising including (category (i)) time of registration at a sample collection site, time of presence in the sample container, time of departure from the sample collection site, time of arrival and storage time at an ana lytic site and (category (ii)) shaking or commotion and temperature and humidity in the physical vicinity of the sample container and others as mentioned above. These param eters may be recorded once, .e.g. in the case of the the time of registration at a sample collection site, the time of presence in the sample container, i.e. the time when a sample is registered as being present in sample container, the time of departure from the sam ple collection site, the time of arrival at an analytic site and storage time since these parameters are associated with single events or the like; or parameters such as shaking or commotion and temperature and humidity in the physical vicinity of the sample con tainer may be recorded during the entire collection, common transportation phase, and goods receipt at the analytic site and, in certain embodiments, additionally the storage at the analytic site. The recording is preferably performed after any suitable interval, which may be predetermined. Such interval may be, for example every 0.1, 1 or 30 sec, or 1, 2, 3, 4, 5, 10, 20, 30 or 60 min. Also envisaged is any other interval which is suitable for the transport and delivery process. It may be adapted to the distance to be covered, as well as traffic and weather conditions, urgency, the sample type and the number of samples transported etc. Further envisaged is an event-triggered recording. Such an event may preferably be a shock or motion event. Also envisaged are temperature events, humidity events etc., e.g. if certain threshold are surpassed. Once such an event is observed, the corresponding information including quantitative values for shock, mo tion, temperature, humidity etc. is registered and stored in the sensor-and-interaction tube. The corresponding information is, in certain embodiments, transmitted to a cloud- based server or further associated devices as described herein. Such a transmission may preferably take place as soon as certain connections are available, e.g. WLAN, Bluetooth, or in periodic intervals, or in an event-triggered manner. [0114] The recording of parameters of category (ii) such as shaking or commotion and temperature and humidity in the physical vicinity of the sample container, is preferably started upon first contact or interaction between the sensor-and-interaction tube and the sample container. The start point of recording may further be recorded and thus the initial contact may be documented. In case more than one sample container is grouped with the sensor-and-interaction tube, some sample container may be added to the group later than others. Temperature and humidity conditions and commotion events which were given or occurred in the absence of said later added sample container may accordingly not be recorded. Advantageously, the start or recording only after contact, i.e. only after the sensor-and-interaction tube and the sample container were brought in physical vicinity, e.g. a common box, bag, envelop etc., allows for distinction of rec orded parameter for each sample container.

[0115] In a further embodiment the recording of parameters of category (ii) such as shaking or commotion and temperature and humidity in the physical vicinity of the sam ple container, is terminated upon arrival at an analytic site. The sensor-and-interaction tube may, for example, be equipped with an automatic switch-off which becomes acti vated once a signal from an analytic site or any other defined destination point has been received. This advantageously prolongs the lifetime of the sensor-and-interaction tube since battery usage will be reduced. The recording may, in certain alternative embodi ments, be continued after arrival at an analytic site. In further embodiment, the record ing activity is permanently available and may be controlled by the presence of sample containers in the physical vicinity of the sensor-and-interaction tube.

[0116] The method of the present invention further comprises, in preferred embodi ments, a step of delivering all parameter values recorded during the pre-analytic phase including the transportation step from the sample container-like sensor-and-interaction tube to a corresponding registration interface at the analytic site. The delivered data may further comprise all, most or some of the data concerning the sample container registered at the collection site as described above, e.g. personal data of the subject whose sample is to be analysed. This personal data may include name, date of birth, address and telephone number, email or secondary information such as name and ad dress or the subject's medical doctor, associated hospital or remitting person, the phle botomises personal data, e.g. the name, address, telephone number etc. of the medical practitioner, nurse or other person who was drawing the sample, data on the origin of the sample, e.g. the name of the hospital, medical practice or any other place where the sample was taken, information on the place and time of collection of the sample, data on the sample type, e.g. whether it is a blood, serum, biopsy sample etc., data on the container type, e.g. its size, form, weight, its material, suitability forthe ordered analysis etc., information on the identity of the person transporting the sample containers, in formation the destination of the sample container, e.g. the address of the analytic site where the sample is to be analysed, data on the filling volume of the sample container, the presence of solid / liquid phase in the container and the presence of a gel layer, data on the centrifugation status of the sample, information on the status of an associated analytical order for the sample; and/or information on the barcode readability of the sample container.

[0117] In a further embodiment, the arrival of the sample containers to an analytic site may be combined with or may additionally comprise the transmission and delivering of all parameter values recorded during the pre-analytic phase and including the transpor- tation step from the sample container-like sensor-and-interaction tube to and from a remote computer server system as defined herein, preferably a cloud-based computer server system, or to and from a mobile data device as defined herein, preferably a mo bile phone or tablet application. For example, the sensor-and-interaction tube may transmit the parameter values recorded during the collection and, in particular, during the transportation step to the remote computer server system or the mobile data de vice.

[0118] In further embodiments, the registration interface at the analytic site or any suit able system at the analytic site independently receives all data concerning the sample container registered at the collection site as described above, e.g. personal data of the subject whose sample is to be analysed. This personal data may include name, date of birth, address and telephone number, email or secondary information such as name and address or the subject's medical doctor, associated hospital or remitting person, the phlebotomises personal data, e.g. the name, address, telephone number etc. of the medical practitioner, nurse or other person who was drawing the sample, data on the origin of the sample, e.g. the name of the hospital, medical practice or any other place where the sample was taken, information on the place and time of collection of the sample, data on the sample type, e.g. whether it is a blood, serum, biopsy sample etc., data on the container type, e.g. its size, form, weight, its material, suitability for the or dered analysis etc., information on the identity of the person transporting the sample containers, information the destination of the sample container, e.g. the address of the analytic site where the sample is to be analysed, data on the filling volume of the sample container, the presence of solid / liquid phase in the container and the presence of a gel layer, data on the centrifugation status of the sample, information on the status of an associated analytical order for the sample; and/or information on the barcode readabil ity of the sample container. This independent transmission may be performed with the help of a remote computer server system, e.g. cloud-based, or the mobile data device.

[0119] In further embodiments, the data received from the sensor-and-interaction tube may be compared with the data received from the remote computer server system or the mobile data device to detect possible discrepancies and to verify the identity of the samples and sample container.

[0120] In particularly preferred embodiments said analytic site comprises a clinical in formation system, e.g. a LIS system, a KIS system, a CPOE system, or a KAS system. The term "LIS" or "Laboratory Information System" as used herein, refers to an information management system, typically comprising a complex of hardware and software compo nents that support the management of collection, processing, storage, distribution, and information representation procedures used with information that has been obtained as a result of laboratory activities. Typically, the LIS comprises the one or more of the following functions: (i) enrolment of samples, i.e. the assignment or reception of a unique identifier and recording of information (e.g. customer, description of sample, security information, storage conditions, performed tests, costs, etc.); (ii) assignment of a sample to analysis, i.e. display of a list of all required tests in combination with moni toring 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 auto matic input of results and statistical processing, whereby unusual results or results that fall outside the range may be marked (to avoid loss of data, back-up copies and emer gency recovery may also be included; (v) verification and validation (e.g. by using audit trails); and (vi) generation of report forms (e.g. quality certificates, test protocols, and analysis certificates). A similar concept is the "KAS" or "Klinisches Arbeitsplatzsystem" which provides as a front-end the decentralized information access in its entirety for the hospital staff at the respective workplace. The KAS is typically a part of the "KIS" or "Krankenhausinformationssystem", i.e. the entirety of all information-processing units for processing medical and administrative data in the hospital. The term "CPOE" stands for computerized physician order entry and relates to a process of electronic entry of medical practitioner instructions for the treatment of patients under his or her care.

[0121] In a further embodiment the analytic site may comprise a sample analyzer infor mation technology unit which connects and controls a plurality of sample processing and measuring analyzers, or an independent autonomously working sample analyzer unit.

[0122] It is particularly preferred that the LIS system, KIS system, CPOE system, or KAS system or the sample analyzer information technology unit or autonomously working sample analyzer unit receives all, most or some of the parameter values from the sam- ple-container-like sensor-and-interaction tube and the barcode or QR code of a sample container via a cloud-based computer server system automatically or upon initiation. The automatization may be implemented by a gateway functionality at the entrance of the analytic site, i.e. an arrival or receiving station for the sample containers. This gate way functionality may, for example, be based on Bluetooth transmissions and automat ically detect the arrival of a sensor-and-interaction tube. The therein registered and rec orded data and parameters may subsequently transmit the data to a remote computer server system, e.g. a cloud-based computer server system, which then transmits the data to the LIS, KIS, CPOE or KAS, or the sample analyzer information technology unit or autonomously working sample analyzer unit, or the data may directly be transmitted to the LIS, KIS, CPOE or KAS and may optionally, form there, be transmitted to the remote computer server system, e.g. a cloud-based computer server system. The transmission upon initialization may comprise a signal to an operator at the analytic site who subse quently authorizes a transmission of the data to the LIS, KIS, CPOE or KAS, or the sample analyzer information technology unit or autonomously working sample analyzer unit.

[0123] Subsequent to the transmission of the data to the LIS, KIS, CPOE or KAS system or the sample analyzer information technology unit or autonomously working sample analyzer unit and/or the remote computer server system, e.g. a cloud-based computer server system, a quality check of the recorded data may be started. This quality check may, for example, be performed by a machine learning and data processing unit as de scribed herein above. For example, the unit may be configured to perform an evaluation of sample registration data and/or measured parameters, preferably of image data, an analysis of sample images taken during the registration steps by a device; an autono mous calculation of key performance indicators (KPIs) or quality indicators obtained dur ing the transport process or other pre-analytic steps; and comparison of measured data or parameters with a data or parameters derived from a database, preferably an internal database. The unit may make use of suitable machine learning or Al algorithms known to the skilled person. For example neural networks such as CNNs or DCNNs may be used. [0124] The received parameter values may accordingly be checked and it is determined whether one or more surpass or fall short of a predetermined threshold. The corre sponding threshold may, for example be associated to a sample container, a sample type, a certain distance, an analytic order, the filling status etc.

[0125] In case the received parameter values surpass or fall short of a predetermined threshold the sample containers with such deviant values may be separated from the other sample containers. This preferably performed in an automatized manner leading to an automated sorting and processing of samples according to predefined values and thresholds. In case the received parameter values surpass or fall short of a predeter mined threshold this may further results in an automatized separation of said sample container and/or an automatized alert of incoming goods or analytic personal and/ or the processing of samples in deviating manner from pre-programmed sample fate. The term "deviating manner" means that specific activities are started which are not typical forthe standard sample processing. This may comprises one or more of specifically sort ing the sample container, picking the sample container, placing the sample container in a specific sequence, re-labelling of sample barcodes on the sample container or predic tive labelling of aliquot containers, samples aliquoting or splitting or diluting or adding stabilization reagent, sample processing or sample measurements in a re-arranged pri ority and sequence on sample analyzer units, and/or preparation of or filling with rea gent necessary for carrying out one or more biochemical assay

[0126] One typical option is sample rejection. Sample rejection is preferably performed at incoming good department during sample registration process even before the sam ples are introduced into the analytical processes in the laboratory. This could include sample sorting in so called pre-analytical laboratory modules, e.g. bulk sorter/ sample sorter. Either as stand-alone machines or as integrated module and linked to pre-ana- lytical sample transport solution, e.g. pneumatic tube systems, conveyor belts for transport bags/ boxes, aliquoting modules, centrifuges, de-/recapper modules, as well as lab analyzers downstream. In a further additional embodiment, this separation may lead to an automatized alert of incoming goods or analytic personal.

[0127] In a further additional embodiment, any information is provided to the analytic personal or LIS, etc. to provide information about the sample quantity, urgency of test ing, ordered tests etc. registered at the collection site to optimize pre-analytical sample flow and control logistics fleet according to the real need and control sample pick-up. The information about, for instance, sample quantity at the collection site may be uti lized for a demand-controlled sample logistics, preferably over the entire network asso ciated with the analytic site, or with associated with a sub-network. Feedback infor mation on the quantity may further be used for logistics adaptation processes, e.g. in case of unexpected quantities, very high or very low quantities of samples, an unex pected quantity of high or low priority samples, or very high or very low quantities of high or low priority samples etc. corresponding demand changes may lead to the acti vation of additional couriers or the change of an urgency status, e.g. a request for accel erated transport, or a request for slowed down transport.

[0128] In a further embodiment, any information is provided into a LIS, etc. or middle ware, information management system controlling utilization of laboratory analyzer to a) control sample flow on highly automated analyzer and thus machine utilization and workload. Due to predictive and expected sample entry at analytical site, predictive an alyzer utilization will allow to run quality controls, load new test reagent cassettes, per form calibration runs ahead of time and use analyzer slots on different modules for test ing purpose in an optimized testing sequence instead of the first-in-first-out principle and thus increase productive analyze utilization, decrease laboratory running costs and improve total turnaround times for diagnostic.

[0129] In a further additional embodiment, any deviating parameter may lead to an au tomatized alert of incoming goods or analytic personal. The personal may accordingly react and take care of subsequent process steps such as requesting further samples, quality management assurance steps, changing the urgency status, communication with collection site, with couriers etc.

[0130] In another preferred embodiment, the parameter value is provided in a digital ized form. Accordingly, data, e.g. derivable from captured images etc. or during the reg- istration process at the collection site may be digitalized during the registration proce dure. This activity may be performed in a suitable microprocessor in the scanning device or after the information has been provided to a remote computer server system as de scribed or the information has been provided to a mobile device, in a LIS system as de scribed herein. [0131] In an additional aspect, the present invention relates to a computer imple mented method for obtaining, processing, storing and optionally transmitting pre-ana- lytical values for sample parameters or sample-associated parameters comprising a sub ject's sample(s) as described herein.

[0132] In yet another aspect, the present invention relates to a computer program com- prising instructions which, when the program is executed by a computer, cause the com puter to carry out the methods as defined herein above.

[0133] 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 a scanning device, mobile phone or table application, an LIS, a sensor-and-interaction tube or from wearable(s) and the presentation of information on one or more different interface(s) such as a web- interface or a tablet or mobile phone app.

[01S4] Any of the parameter determining methods described herein may be totally or partially performed with a computer system including one or more processor(s), which can be configured to perform the steps. Accordingly, some of the present embodiments are directed to computer systems configured to perform the steps of any of the moni toring methods described herein, potentially with different components performing re spective steps or a respective group of steps. Corresponding steps of methods may fur ther be performed at the 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 performed with modules, circuits, or other means for performing these steps. It is particularly preferred that at least some of the methods are performed on a cloud- based computer system.

[0135] The example, 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 modifica tions of the principles laid out herein.

EXAMPLES

Example 1

Hospital, inpatient setting · Doctor makes decision for laboratory analysis and delegates further down.

• Assistant doctor / nurse creates a laboratory order in the CPOE for the patient in the doctor's room.

• Assistant doctor / nurse prints out the barcodes for the blood tubes (sample containers) in the doctor's room and affixes the associated blood tubes by cap color, fixed barcode for a specific tube color.

• Assistant doctor/ nurse = "phlebotomist" takes a cell phone or any appropriate scanning device and consumables (tubes, needles, etc.) for blood draw and goes to the patient's bed in the ward, usually until the next morning before breakfast/ day and po tentially a different person is preparing the lab order and consumables than taking the samples.

• Phlebotomist logs into the app or scanning application with his login and uses it to verify himself, either at the bed or already in the doctor's room. The app recognizes its exact location by the user / WIFI / mobile phone.

• Either on the bed or already in the doctor's room: Phlebotomist scans the smart tube (sensor-and-interaction tube) and links it to its tour.

• Phlebotomist scans the patient's hospital wristband and uses it to verify the pa tient (patient ID, if applicable, name, date of birth or other is displayed). • The app pulls the laboratory order from the LIS in the background and displays a sample list.

• Phlebotomist draws blood, in the order shown in the app (via color code cap and barcode). · Phlebotomist scans the blood tube (sample container) barcodes immediately after the blood draw.

• For each barcode, the phlebotomist must manually confirm the tube type (e.g. serum, red). The tube type is automatically read from the barcode (e.g. suffix 01 => red cap => serum) and verified by the phlebotomist. Changes in the event of deviations can be entered here.

• The app compares the actual tube scan with the expected order list and shows which tubes of the laboratory order have already been recorded and which are still miss ing. Verification of the tube type is performed as described above.

• App virtually links the blood tubes with the active smart tube (sensor-and-inter- action tube).

• Phlebotomist scans the patient's wristband again.

• Phlebotomist confirms the end of blood sampling.

• Phlebotomist confirms the transport of the tubes (sample containers) to the laboratory ("Start Transport") or goes to the next patient on his tour, then transport starts only after the last patient. o All other blood tubes (sample containers) are virtually linked to the ac tive smart tube (sensor-and-interaction tube). o At StartTransport, the smart tube (sensor-and-interaction tube) "leaves" the phlebotomist and his acceptance and goes to "Transport". o The smart tube (sensor-and-interaction tube) already records during the acceptance tests and, of course, during the transport to the laboratory (analytic site) until arrival in the laboratory, optionally also later during further processing or storage.

Claims

1. A sampling method for taking a subject's liquid sample and for obtaining, pro cessing, storing and optionally transmitting pre-analytical values for sample parameters or sample-associated parameters, comprising the steps:

(i) registering one or more of the parameter values(s): time of registration of a subject at a sample collection site before the sample is taken; identity of the subject before the sample is taken; the subject's personal data before the sample is taken; health condition of subject before the sample is taken; identity and location of the sample collection site before the sam ple is taken; identity of the person drawing the subject's sample (phleboto- mist) before the sample is taken; sample type before the sample is taken; intended test for sample before the sample is taken; destination of the sample container before the sample is taken; sample container type and identity before the sample is taken; status of associated analytical order for the sample before the sample is taken;

(ii) taking a subject's sample and subsequently registering one or more of the parameter values(s): time of sample taking; centrifugation status of the sample; filling volume of the sample container; time of departure of sample from the sample collection site; time of arrival of sample at an analytic site; shaking or commotion of the sample between time of sample tak ing and time of arrival at the analytic site; and (iii) processing, storing and optionally transmitting said parameters; wherein said parameter value(s) is/are registered, processed, stored and op tionally transmitted by a sample-container-like-sensor-and-interaction tube, which is brought into physical vicinity of the sample container before sample taking and kept in physical vicinity of the sample container during the pre- analytical phase, preferably until arrival at the analytic site.

2. The method of claim 1, wherein the parameter health condition of a subject comprises sobriety, pregnancy, blood pressure or wherein a free text note regarding the health status of a subject is provided.

3. The method of claim 1 or 2, wherein said sample container is provided with an identifier such as a specific barcode or QR code which is initially present on the sample container or is attached to the sample container after sample taking.

4. The method of claim 3, wherein said identifier comprises encoded infor mation relating to at least one selected from the group: manufacturer, man ufacture time stamp, use period, batch number, sample container type and article number or wherein said identifier is linked to a central or cloud-based database containing at least one information item selected from the group: manufacturer, manufacture time stamp, use period, batch number, sample container type and article number.

5. The method of any one of claims 1 to 4, wherein said parameter value(s) are registered on the sample-container-like-sensor-and-interaction tube and/or independently on a remote computer server system, preferably a cloud- based computer server system.

6. The method of claim 5, wherein said registration is performed in a registra tion scanning device for sample containers and/or in a mobile phone or tablet application or a web-browser based scanning application.

7. The method of claim 6, wherein the registration additionally comprises one or more of:

(i) registration and verification of a phlebotomistto a program which is linked to the registration scanning device for sample containers, preferably in an a mobile phone or tablet application or web-browser based scanning applica tion;

(iii) registration of the subject via a patient file identification number;

(iv) registration of the subject via an informed consent identification number;

(v) registration of the subject via biometric data;

(vi) registration of the subject via a wearable, preferably a smart watch or smart bracelet,

(vii) registration of the subject via mobile phone or tablet authentication, preferably via a customer authentication application such as scanning of a provided barcode, QR code or image; and

(viii) registration and verification of a person transporting the sample con- tainer(s).

8. The method of claim 7, wherein the registration via biometric data comprises one or more of (i) face scan, preferably via a mobile phone or tablet; (ii) fin gerprint scan, preferably via a mobile phone or tablet; (iii) scan of a passport or ID card; (iv) scan of an insurance card; (v) scan of a driver's licence; and (vi) scan of a photo ID card.

9. The method of any one of claims 2 to 8, wherein the sample-container-like- sensor and-interaction tube is virtually linked to the one or more sample con tainers) in its physical vicinity, wherein said virtual linkage comprises the re cording of sample container information items and parameter values by the sensor-and-interaction tube.

10. The method of claim 9, wherein the recording and virtual linkage is initiated in an automatic or semi-automatic manner via contactless communication between the sample-container-like-sensor and-interaction tube and a regis tration scanning device for sample containers, preferably a mobile phone or tablet application or web-browser based scanning application.

11. The method of claim 10, wherein the contactless communication is per formed via RFID (radio frequency identification), Bluetooth interaction, GSM, LTE, G5, LPWAN, LoRaWAN, or WiFi, preferably Bluetooth.

12. The method of any one of claims 5 to 11, wherein the recorded information items, parameter values and the virtual linkage data are transmitted to a re mote computer server system, preferably a cloud-based computer server system, or to a mobile data device, preferably a mobile phone or tablet ap plication.

13. The method of any one of claims 1 to 12, wherein said sample-container-like- sensor-and-interaction tube records said one or more parameter values(s) in the physical vicinity of the sample container during the entire phase between the first registration before a sample is taken and the arrival at the analytic site.

14. The method of claim IB, wherein said recording is performed after predeter mined intervals, preferably every 0.1, 1 or 30 sec, or 1, 2, 3, 4, 5, 10, 20, 30 or 60 min, or wherein said recording is event-triggered, preferably by a shock or motion event.

15. The method of any one of claims 1 to 14, comprising the additional step of delivering one or more, preferably all parameter values recorded during the registration, collection and transportation step with said sample container- like-sensor-and-interaction-tube to a data interface of a mobile phone or tab let application and/or at the analytic site via contactless communication.

16. The method of claim 15, wherein said delivering of one or more, preferably all parameter to a mobile phone or tablet application and/or to the analytic site is performed during sample transport.

17. The method of any one of claims 1 to 16, wherein said analytic site comprises a clinical information system such as a LIS system, a KIS system, a CPOE sys tem, or a KAS system or a sample analyzer information technology unit con necting and controlling a plurality of sample processing and measuring ana lyzers, or an independent autonomously working sample analyzer unit.

18. The method of claim 17, wherein the received parameter values are inte grated into the clinical information system and/or the sample analyzer sys tem and/or the sample analyzer information technology unit connecting and controlling a plurality of sample processing and measuring analyzers.

19. The method of claim 18, wherein said parameter value integration is per formed via a cloud-based server system automatically, periodically or by re quest, preferably 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.

20. The method of any one of claims 17 to 19, wherein said LIS system, KIS sys tem, CPOE system, or KAS system receives all parameter values from the sample container-like-sensor-and-interaction tube and the barcode or QR code of a sample container via a cloud-based computer server system auto matically or upon initiation.

21. The method of any one of claims 15 to 20, wherein a recorded and delivered parameter value which surpasses or falls short of a predetermined threshold, which is associated to a sample container, results in an automatized separa tion of said sample container and/or an automatized alert of incoming goods or analytic personal and/ or the processing of samples in deviating manner from pre-programmed sample fate.

22. The method of claim 21, wherein said processing in deviating manner com prises one or more of sorting the sample container, picking the sample con tainer, placing the sample container in a specific sequence, re-labelling of sample barcodes on the sample container or predictive labelling of aliquot containers, samples aliquoting or splitting or diluting or adding stabilization reagent, sample processing or sample measurements in a re-arranged prior ity and sequence on sample analyzer units, and/or preparation of or filling with reagent necessary for carrying out one or more biochemical assay.

23. The method of any one of claims 1 to 22, wherein said parameter value is provided in a digitalized form.

24. The method of any one of claims 3 to 23, wherein said barcode or QR code comprises remote database accessory data and optionally one or more of subject specific data, sample specific data and intended analysis-related data.

25. The method of claim 24, wherein said remote database accessory data pro vides a link to a database entry, wherein subject specific data, sample specific data and/or intended analysis-related data are registered