GB2597686A - Pre-analytic management of sample container parameters - Google Patents

Abstract

A method for obtaining and managing pre-analytical values for one or more parameter(s) of one or more sample containers comprising a subject’s sample(s), the parameters being collected and managed from the time of sample collection at a collection site through storage at the collection site, transportation to a analytic site and receipt at the analytic site, wherein a sensor and interaction tube obtains and manages the parameters through being placed and kept in physical vicinity with the sample containers. The parameters are time of registration at the sample collection site, identity of the subject, identity of the person drawing the subject's sample (phlebotomist), time of departure from the sample collection site, time of arrival at the analytic site, shaking or commotion of the containers, temperature and humidity. The sensor and interaction tube is a receptacle which has an identical form to the sample container but does not contain a sample, and comprises means for contactless communication such as Bluetooth or an RFID unit to send and receive data, and sensors for recording environmental conditions such as temperature, humidity and vibration or motion. Data may be sent during transport. The method is applied to the transport of patient samples such as blood from a point of collection to a point of analysis.

Description

Pre-analytic management of sample container parameters

FIELD OF THE INVENTION

[0001] The present invention relates to a method for obtaining and managing pre-analytically values for one or more parameter(s) of one or more sample containers comprising a subject's sample(s), wherein said parameter(s) comprise time of registration at a lo sample collection site, identity of the subject, identity of the person drawing the sub-ject's sample (phlebotomist), time of departure from the sample collection site, time of arrival at an analytic site, shaking or commotion, as well as temperature and/or humidity in the physical vicinity of the sample container, wherein said parameter value(s) is/are obtained and managed in a sample container-like sensor and interaction tube, which is brought and kept in physical vicinity of the sample containers during the pre-analytical phase, preferably during collection, storage at the collection site, common transportation to the analytic site and goods receipt at the analytic site.

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 strategies based on their individual diagnosis.

[0003] Digitization and smart technologies enable pharmaceutical and biotech companies to perform quantum leaps in research and drug development. Due to more precise analysis and innovations in the field of precision medicine, more sensitive tests and specific differential diagnoses become possible. Blood-based biomarker tests are gaining in importance. As a result, significantly more blood samples will be collected, sent and 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 tumor 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, din 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 to the tube during the production phase to allow or inhibit specific biochemical reactions (e.g. coagulation) or stabilize specific biomarkers (see Sarstedt AG & Co KG, Numbrecht, Colour coding in blood collection, 2018) and labelling it with the correct and patient-specific barcode or label, is highly error-prone. Sample tubes, barcodes and the identity of the patient must be verified during or directly after sample collection. Especially if collection tubes are prepared with barcodes at an earlier time-point, wrong sample tubes may potentially be used, or they may be linked to the wrong patient (von Meyer et al., 2019, Diagnosis, 6(1), 1-3). Thus, verification of a patient's identity is absolutely essential as well as identification of healthcare practitioner taking blood is already legally mandatory io for some specific blood sample collections, e.g. cross-matching blood samples for blood compatibility tests ("Richtlinie der Bundesarztekammer zur Qualitatssicherung laboratoriumsmedizinischer 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 temperature. Subsequently, it may be necessary to centrifuge the samples, e.g. at 1000 g for 10 minutes at 18 -25 °C. Finally, the samples must be stored under specific temperature conditions until processing in the analytical phase or transport to an analytic site (Sar-stedt AG & Co KG, Nambrecht, Tips & Techniques in Preanalytics, 2018). Nevertheless, elapsed time between sampling and analysis must not exceed specific individual thresholds 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 affected 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 io 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 laboratories with respect to their accreditation. According to the International Standard for med-ical laboratories accreditation (ISO 15189: 2012) "the laboratory shall establish quality indicators (QI) to monitor and evaluate performance throughout critical aspects of pre-examination, examination and post-examination processes" and "the process of monitoring Qls shall be planned, which includes establishing the objectives, methodology, interpretation, limits, action plan and duration of measurement". Therefore, the esta b-lishment of Qls covering the entire diagnostic process should be considered "a must" for complying with the requirements of the International Standard and achieving accreditation. Recommended 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, din Chem Lab Med, 53(6), 943-948). During the last decades blood-based tests were improved by developing technically advanced laboratory analyzers by focusing on the analytical procedures in the lab, leading to a technical error rate below 0.1% today. Internal quality controls (QCs) are 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 laboratory 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 io 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- is 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, sample 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 automated laboratory process and the management of associated patient data such as personal 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 method for obtaining and managing pre-analytically values for one or more parameter(s) of one or more sample containers comprising a subject's sample(s), wherein said parameter(s) comprise time of registration at a sample collection site, identity of the subject, identity io of the person drawing the subject's sample (phlebotomist), time of departure from the sample collection site, time of arrival at an analytic site, shaking or commotion, as well as temperature and/or humidity in the physical vicinity of the sample container, wherein said parameter value(s) is/are obtained and managed in a sample container-like sensor and interaction tube, which is brought and kept in physical vicinity of the sample con- tainers during the pre-analytical phase, preferably during collection, storage at the col-lection site, common transportation to the analytic site and goods receipt at the analytic site. This method advantageously provides a solution with respect to the 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 laboratory. Furthermore, sample history and verification of patient identification becomes possible and thus allows for a secure and traceable quality assurance approach for human samples. The present invention thus provides the means and methods for a digital, automated and seamless sample quality control and surveillance from sample collection to lab analysis. The presently claimed and herein described technology accordingly raises the safety, quality, au-ditability and traceability of samples such as blood samples to an unprecedented level.

The managing of pre-analytic values of patient samples and their integration with pa-tients' personal data drastically reduces the risk of incorrect clinical data due to improper handling, mislabeling or other pre-analytical errors and improves compliance with regulatory requirements, e.g. pursuant to ISO 15189:2012.

[0011] In a preferred embodiment, said sample container is provided with a specific bar-code or QR code.

[0012] In a further preferred embodiment, for each sample container one or more information items or parameter values selected from: the subject's personal data, the phlebotomist's personal data, the origin of the sample, place and time of collection of the sample, sample type, container type, destination of the sample container, filling vol- ume of the sample container, centrifugation status of sample, status of associated ana-lytical order for the sample, or barcode readability of container are registered.

[0013] 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.

[0014] It is further preferred that the registration of data comprises one or more of (i) registration and verification of a phlebotomist's login to a program which is linked to the registration scanning device for sample containers, preferably in an a mobile 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) registra-tion 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, OR code or image, or (viii) registration of a person transporting the sample container(s).

[0015] 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, preferably 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.

[0016] 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.

[0017] 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.

[0018] It is particularly preferred that the contactless communication is performed via RFID (radio frequency identification), Bluetooth interaction, GSM, LTE, GS, LPWAN, LoRaWAN, or WiFi, preferably Bluetooth.

[0019] 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.

[0020] In a particular embodiment of the present invention, said sensor and interaction tube records said one or more parameter values(s) comprising (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 analytic site once; and (ii) shaking or commotion, as well as temperature and humidity in the physical vicinity of the sample container during the entire collection, common transportation phase, goods receipt at the analytic site and storage at the analytic site.

[0021] In a specific embodiment said recording is performed after predetermined 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.

[0022] In another specific embodiment of the present invention, said recording is started upon first contact with a sample container. In another embodiment, said record-ing is terminated upon arrival at an analytic site.

[0023] In preferred embodiment of the method according to the present invention said sample container-like sensor and interaction tube delivers all parameter values recorded during the collection and transportation step to a corresponding registration in-terface at the analytic site.

[0024] In a further preferred embodiment said delivery additionally comprises transmission to and from a remote computer server system, preferably a cloud-based computer server system, or to and from a mobile data device, preferably a mobile phone or tablet application.

[0025] 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. It is particularly preferred that said 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 OR code of a sample container via a cloud-based computer server system automatically or upon initiation.

[0026] 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.

[0027] In yet another preferred embodiment of the method of the present invention, said parameter value is provided in a digitalized form.

[0028] In a further preferred embodiment, said barcode or OR code comprises remote database accessory data. Optionally, it may also comprise one or more of subject specific data, sample specific data and intended analysis-related data.

[0029] 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

[0030] Figure 1 provides an overview of some components of the method according to io 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 preparation; selection of test, receiving and completing of order form (electronic Order Entry/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, a liquoting; 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 organizing 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-pie processing, splitting, relabeling, and preparation. Element F relates to sample analytics including sample quality check (e.g. serum/ hemolytic index); performance of sample testing; and sample sorting and retesting. Element G relates to post analytics including 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.

[0031] Figures 2 shows embodiments of the process and data low according to specific embodiment of the present invention.

[0032] 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 invention. These features include data storage: with 30,000 measuring points and a redundant ring buffer; electronics: with a definable sampling rate (e.g. 1/ min) and event triggered, 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.

[0033] Figure 4 depicts features of a mobile application according to embodiments of the present invention.

[0034] Figure 5 depicts further features of a mobile application according to embodi-ments of the present invention.

[0035] Figure 6 shows transport data providing an individual sample history according to a specific embodiment of the present invention.

[0036] Figure 7 provides an a na lytics summary of pre-analytical quality data according to an embodiment of the present invention.

[0037] Figure 8 shows LIS integration of the process according to an embodiment of the present invention.

DETAILED DESCRIPTION OF THE EMBODIMENTS

s [0038] Although the present invention will be described with respect to particular em-bodiments, this description is not to be construed in a limiting sense.

[0039] Before describing in detail exemplary embodiments of the present invention, definitions important for understanding the present invention are given.

[0040] 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.

[0041] 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 %.

[0042] 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 considered 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.

[0043] 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 distinguishing 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.

[0044] It is to be understood that this invention is not limited to the particular methodology, apparatus, components, units, protocols, reagents, etc. described herein as these may vary. It is also to be understood that the terminology used herein is for the purpose io of describing particular embodiments only and is not intended to limit the scope of the present invention that will be limited only by the appended claims. Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of ordinary skill in the art. For the purpose of the present invention, all references cited herein are incorporated by reference in their entireties.

[0045] 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 feasible combination of the embodiments described below. Furthermore, the present disclosure 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.

[0046] As has been set out above, the present invention concerns in one aspect a method for obtaining and managing pre-analytically values for one or more parameter(s) of one or more sample containers comprising a subject's sample(s), wherein said parameter(s) comprise time of registration at a sample collection site, identity of the subject, identity of the person drawing the subject's sample (phlebotomist), time of departure from the sample collection site, time of arrival at an analytic site, shaking or commotion, as well as temperature and/or humidity in the physical vicinity of the sample container, wherein said parameter value(s) is/are obtained and managed in a sample container-like sensor and interaction tube, which is brought and kept in physical vicinity of the sample containers during the pre-analytical phase, preferably during collection, storage at the collection site, common transportation to the analytic site and goods re-ceipt at the analytic site.

[0047] 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. If liquid materials are com-prised 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 for the generation of vacuum in the container after filling.

[0048] 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. [0049] For example, the container may comprise, before any sample is filled in, a reagent or compound. For example, the container may comprise a stabilizing agent, which assists in preserving the sample. In further embodiments, the container may comprise reagents necessary for carrying out one or more biochemical assay(s) such as a buffer, nucleotides, an enzyme, a dye, etc. In yet another embodiment, the container may comprise an element, which allows to molecularly identify or characterize or tag a sample.

For example, a molecular tag such as an artificial DNA sequence which can be retrieved and identified may be present in the container. Alternatively, an electronically identifiable particle may be provided in the container. These elements can either be filled in before the sample is added, or 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 invention also envisages sample containers for cold transport at very low temperatures, e.g. temperatures below 0°C, -5°C, -20°C, -30°C, -40°C or 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, storage, 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.

[0050] 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 embodiment, the sample container is a biopsy collection tube. Accordingly, the sample container is designed to fulfil all necessary regulatory requirements for biopsy transport, storage and/or diagnosis. In yet a further group of embodiments, the sample container is a container or tube designed to receive a biological fluid such as urine, semen, sweat, sputum, saliva, feces or stool. Accordingly, the sample container is designed to fulfil all necessary regulatory requirements for transport, storage and/or diagnosis of a biological 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. [0051] In preferred embodiments, the sample container comprises a scannable identifier. Examples of envisaged identifiers include a barcode, a matrix code, a OR code or an lo electronic code such as flash memory, EPROM or [[PROM. In certain embodiments, an RFID or NEC component or tag may be integrated into the barcode or matrix code. For example, the barcode, matrix code or QR code may be provided in the form of a sticker or an adhesive label on the surface of the sample container.

[0052] In particularly preferred embodiments, the barcode, a matrix code, a OR code comprises remote database accessory data. The remote database accessory data may, for example, provide a link to a database entry, wherein subject specific data, sample specific data and/or intended analysis-related data are registered. The barcode, a matrix code, a OR code may, in certain embodiments, also comprise one or more of subject specific data, sample specific data and intended analysis-related data. By scanning the barcode, a matrix code, a OR code thus either a link to the database or a direct trans-mission of the encoded data to the scanning device is initiated.

[0053] The method of the present invention further envisages the use and presence of a sample container-like sensor and interaction tube. This tube is typically brought and kept in physical vicinity of the sample container during the pre-analytical phase. Advan- tageously, the employment of such sensor and interaction allows for the detection, re-cording and registration, as well transfer of data and parameters associated with the sample container which are transported together with said sensor and interaction tube, as well as with parameters associated with the sample collection and transport itself.

The "sample container-like sensor and interaction tube" as used herein relates to a receptacle which has a similar or identical 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 container-like sensor and interaction tube may have a differ-ent size, e.g. smaller or bigger size and/or different form as the sample container.

[0054] According to the invention, the sensor and interaction tube, instead of comprising a sample, is equipped with suitable units and modules to allow for the recording, detection, registration and transmittal functions described herein.

[0055] 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 station 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 Blue-tooth. 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 bar-codes or OR codes. Examples of such additional devices include handheld scanners.

[0056] The term "unit for contactless communication" relates to an electronic or computerized element, which either actively sends out a signal to a base station or works passively and may react to a signal generated by a base station. In both scenarios, the signal may be transmitted without direct physical contact between the sample container-like sensor and interaction tube and a base station, e.g. via radio waves.

[0057] 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).

[0058] In preferred embodiments the unit may be configured for data transmission such io as an RFID unit, an NFC unit, a GSM, LTE or GS unit, a LPWAN unit, a LoRaWAN unit, a Bluetooth unit or a WiFi unit as defined herein.

[0059] The unit for contactless communication may in certain embodiments, also be based on high-speed wireless communication standards such as GS, LIE (long-term evolution), or GSM/EDGE or UMTS/HSPA technologies, or any other suitable high-speed wireless communication technology or standard, e.g. also technologies which will be 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.

[0060] 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 additionally be capable of transferring data with further protocols such as NarrowBand 101 (NBloT). NarrowBand loT (NB-loT) is a Low Power Wide Area Network (LPWAN) radio technology standard developed to enable a wide range of devices and services to be 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 (enhanced Machine-Type Communication) and EC-GSM-IoT. In further embodiments, the unit for contactless communication may be a Long Range Wide Area Network (LoRaWAN) module. LoRa is a LPWAN protocol, which enables long-range transmissions, e.g. 10 km or more, with low power consumption.

[0061] According to further embodiments of the invention, the sensor and interaction tube is additionally or alternatively equipped with a unit for the measurement of temperature such as an electronic temperature sensor. The unit is designed to measure the temperature in the physical vicinity of the sensor and interaction tube and thus, if the io sensor and interaction tube is kept in physical vicinity of one or more sample container, also in the physical vicinity of said sample container. The tube and the sample containers, may, for example, be together in a box, bag, envelop, parcel or any other means of transport and compilation. Since the temperature within a close physical vicinity, e.g. in common box, bag, envelop etc. is assumed to be identical or highly similar for all items in physical vicinity, i.e. for the sensor and interaction tube and the sample containers, the measured temperature is taken as representative for the temperature of all sample containers grouped with the sensor and interaction tube.

[0062] According to further embodiments of the invention, the 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 determining 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 movements 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 sensor and interaction tube and for the sample containers, the measured vibrational parameter is taken as representative for the shaking and commotion parameter of all sample containers grouped with the sensor and interaction tube.

[0063] According to further embodiments of the invention, the sensor and interaction tube is additionally or alternatively equipped with a unit for the measurement of humidity. The unit may, for example, be capable of determining 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 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 sensor and interaction tube and for the sample containers, the measured humidity parameter is taken as representative for the humidity parameter of all sample containers grouped with the sensor and interaction tube.

[0064] According to further embodiments of the invention, the sensor and interaction tube is additionally or alternatively equipped with a chronometer 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 measurement of certain parameters, as well as the provision of time stamps for certain events or incidents.

[0065] According to embodiments of the invention, the 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 parameters associated with a sample container to be transported together with the tube. The unit may, for example, receive, store and provide any parameter value received with any of the above described units, sensors or modules. The unit further preferably receives, stores and provides data concerning the time of registration at a sample collection site, the identity 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 cou-rier, the time of arrival at an analytic site and storage time at the analytic site.

[0066] 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 essentially 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-tamer, but are associated to it via the sample container-like sensor and interaction tube, which operates as a chaperone for said sample containers. In certain embodiments, parameter value(s) is/are obtained and subsequently 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 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.

[0067] In preferred embodiments, the information items or parameter values which are registered include: The sample container identity, e.g. a number, code such as a barcode or OR 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 iden- tity is preferably used as one key information item within a database or data ware-house structure to retrieve and organize further data on the sample and/or patient associated etc. - 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 phlebotomist's personal data, e.g. the name, address, telephone number etc. of the medical practitioner, nurse or other person who was drawing the sample.

- The origin of the sample, e.g. the name of the hospital, medical practice or any other place where the sample was taken. This may include address, telephone number and/or email etc. -The place and time of collection of the sample. The place may be registered via GPS coordinates or other suitable electronic map information.

- The sample type, e.g. blood, serum, biopsy sample etc. - The container type, e.g. its size, form, weight, its material, suitability for the ordered analysis etc. -The identity of the person transporting the sample containers, e.g. a courier.

- The destination of the sample container, e.g. the address of the analytic site where the sample is to be analysed.

- The filling volume of the sample container, e.g. whether the sample container is entirely filled or whether the filling status is at least partially empty. Further param-eters include the presence of solid / liquid phase in the container and the presence of a gel layer.

- The centrifugation status of the sample, e.g. the sample has not been centrifuged, or the sample has been centrifuged with a certain speed etc., the speed and time of centrifugation.

- The status clan associated analytical order for the sample; and/or: - The barcode readability of the sample container.

[0068] The information parameter values or items are preferably received, stored, transported and provided upon arrival to an analytic site.

[0069] 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.

[0070] 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-tamer, 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 OR 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 number, 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 analyses to be performed.

(iv) A unit for registration and verification of the phlebotomist's login 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 sample 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 cardiac 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-nod 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 corresponding sample may be marked as unusable. In such a scenario, a further, new sample 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 associated with its location, e.g. under the skin.

(vi) A unit for linkage to a remote computer server system and/or a remote database system and/or a health information system configured for data transmission and/or a mobile phone or tablet application. The term "health information system" as used herein, refers to a comprehensive, integrated information system designed to manage all the aspects of health related operations, such as medical, administrative, financial, and legal issues and the corresponding processing of services. The system typically provides a common source of information about a subject's health history. The system typ- ically keeps data in a secure place and controls who can reach the data in certain cir-cumstances. 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 io 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 development 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 io 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, OR 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.

[0071] In a further embodiment of the present invention the registration of the sample container identity, the subject's personal data, the courier's personal data, the phlebotomist's personal data, the origin of the sample, place and time of collection of the sam-ple, sample type, container type, destination of the sample container, filling volume of the sample container, centrifugation status of sample, status of associated analytical order for the sample, or barcode readability of container is performed in a mobile phone or tablet application. The mobile phone or tablet application may, for example, be used as scanning device for barcodes, OR codes, or as entry device for personal 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 sam-pie, destination of the sample container.

[0072] The present invention envisages, e.g. on the basis of a registration scanning device or mobile phone or table application as described above, the registration of a set of data. For example, the it is envisaged that the registration of data comprises: (i) registration and verification of a phlebotomist's login to a program. The program may, for example, be linked to the registration scanning device for sample containers or to a mobile 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 performed 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, OR code ic 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.

[0073] 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 pro-cessed. The linkage preferably comprises a recording of sample container information, 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 managing, preferably, personal data of the subject whose sample is to be analysed, the phlebotomist's personal data, the identity of the person transporting the sample containers, e.g. io a courier.

[0074] The virtual linkage is preferably a linkage which works for the entire transport or pre-analytic process. A preferred initiation point is 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. 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 sensor and interaction tube for further transport procedures.

[0075] In further embodiments of the invention, the recorded information items, parameter values and the virtual linkage data are transmitted to a remote computer server system, preferably a cloud-based computer server system, or to a mobile data device, preferably a mobile phone or tablet application. It is particularly preferred that the vir-tual linkage between the sample-container like sensor and interaction tube and the sample containers is mirrored in a cloud-based remote server or computer system and/or in a mobile phone or table applications and/or in a LIS or [IS connected system, e.g. a cloud-system connected to the [IS. 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 invention 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 sample, e.g. once it becomes necessary, for documentation, statistical, quality management or error detection or other purposes.

[0076] The transmitted information may advantageously also include all 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 io personal data of the courier as mentioned above.

[0077] 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 analytic site or a connected gateway module, and mobile device with scanning function-ality. 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 embodiments, 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 multidirectional, allowing for a complete exchange of information, advantageously filtered according to necessities and requirements, e.g. predefined information hierarchies or priority lists, between all integrated elements. It is preferred that the remote 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 communication fashion information or parameter values as described herein form the associated component(s). This information may be accumulated, filtered, organized, verified, compared 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 organizational 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 l<P1s, 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 performed by a mobile data device, e.g. a mobile phone or tablet device.

[0078] According to specific embodiments the sensor and interaction tube as defined herein records one or more parameter values(s) comprising (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 analytic site and (ii) shaking or commotion and temperature and humidity in the physical vicinity of the sample container. These parameters (i) may be recorded once, i.e. 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 sample collection site, the time of arrival at an analytic site and storage time since these parameters are associated with single events, whereas the parameters (ii), i.e. shaking or commotion and temperature and humidity in the physical vicinity of the io sample container are 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, motion, 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.

[0079] The recording of parameters (ii), i.e. 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 recorded parameter for each sample container.

[0080] In a further embodiment the recording of parameters (ii), i.e. shaking or commo-tion and temperature and humidity in the physical vicinity of the sample 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 activated 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 bat-tery usage will be reduced. The recording may, in certain alternative embodiments, be continued after arrival at an analytic site. In further embodiment, the recording activity is permanently available and may be controlled by the presence of sample containers in the physical vicinity of the sensor and interaction tube.

[0081] The method of the present invention further comprises, in preferred embodi- ments, a step of delivering all parameter values recorded during the collection and trans-portation 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 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 phlebotomist's 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 ordered 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 io 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.

[0082] 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 collection and transportation 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 mobile 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 device.

[0083] In further embodiments, the registration interface at the analytic site or any suitable 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 phlebotomist's 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 readability of the sample container. This independent transmission may be performed with the help of a remote computer server system or the mobile data device.

[0084] 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.

[0085] In particularly preferred embodiments said analytic site comprises a clinical information system, e.g. a [IS system, a KIS system, a CPOE system, or a KAS system. The term "[IS" or "Laboratory Information System" as used herein, refers to an information management system, typically comprising a complex of hardware and software components that support the management of collection, processing, storage, distribution, and information representation procedures used with information that has been obtained as a result of laboratory activities. Typically, the [IS comprises the one or more of the following functions: (i) enrolment of samples, i.e. the assignment or reception of a unique identifier and recording of information (e.g. customer, description of sample, security information, storage conditions, performed tests, costs, etc.); (ii) assignment of a sample to analysis, i.e. display of a list of all required tests in combination with monitoring of the execution of assigned analyses, or tracking of time; (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 emergency recovery may also be included; (v) verification and validation (e.g. by using audit trails); and (vi) generation of report forms (e.g. quality certificates, test protocols, and analysis certificates). A similar concept is the "KM" or "Klinisches Arbeitsplatzsystem" io 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.

[0086] It is 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 OR 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 gateway functionality may, for example, be based on Bluetooth transmissions and automatically detect the arrival of a sensor and interaction tube. The therein registered and recorded 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 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 subsequently authorizes a transmission of the data to the LIS, KIS, CPOE or KAS.

[0087] Subsequent to the transmission of the data to the LIS, KIS, CPOE or KAS system 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 described 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 autonomous calculation of key performance indicators (KPIs) or quality indicators obtained during the transport pro-cess 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.

[0088] 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 corresponding threshold may, for example be associated to a sample container, a sample type, a certain distance, an analytic order, the filling status etc. [0089] 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. Sample rejecting is preferably performed at incoming good department during sample registration process even before sample 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-analytical sample transport solution, e.g. pneu-matic 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.

[0090] In a further additional embodiment, any information is provided to the analytic personal or LIS, etc. to provide information about the sample quantity 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 sample quantity at the collection site may be utilized for a demand-controlled sample logistics, preferably -io over the entire network associated with the analytic site, or with associated with a sub-network. Feedback information 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 unexpected 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 activation of additional couriers or the change of an urgency status, e.g. a request for accelerated transport, or a request for slowed down transport.

[0091] 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, perform calibration runs ahead of time and use analyzer slots on different modules for testing 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.

[0092] In a further additional embodiment, this separation may lead to an automatized 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. [0093] 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 procedure. 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 described or the information has been provided to a mobile device, in a LIS system as de-scribed herein.

[0094] In an additional aspect, the present invention relates to a computer implemented method for obtaining and managing pre-analytic values for one or more for one or more parameter(s) of one or more sample containers comprising a subject's sample(s) as described herein.

[0095] In yet another aspect, the present invention relates to a computer program com-prising instructions which, when the program is executed by a computer, cause the computer to carry out the methods as defined herein above.

[0096] 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 instructions or commands on a computer readable medium for storage and/or transmission, suitable media include random access memory (RAM), a read only memory (ROM), a magnetic medium such as a hard-drive, or an optical medium such as a compact disk (CD) or DVD (digital versatile disk), flash memory, and the like. The computer readable medium may be any combination of such storage or transmission devices. Such programs may also be encoded and transmitted using carrier signals adapted for transmission 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 or within a single computer program product (e.g. a hard drive, a CD, or an entire computer system), and may be present on or within io 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, table 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 information, 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.

[0097] 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 monitoring methods described herein, potentially with different components performing respective steps or a respective group of steps. Corresponding steps of methods may further be performed at 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.

[0098] The figures and drawings provided herein are intended for illustrative purposes. It is thus understood that the figures and drawings are not to be construed as limiting. The skilled person in the art will clearly be able to envisage further modifications of the in 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 and consumables (tubes, needles, etc.) for blood draw and goes to the patient's bed in the ward, usually until the next morning / day and potentially a different person than preparing the lab order and consumables.

* Phlebotomist logs into the app 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 io 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 interaction 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 (22)

1. CLAIMS1. A method for obtaining and managing pre-analytically values for one or more parameter(s) of one or more sample containers comprising a subject's sam-ple(s), wherein said parameter(s) comprise time of registration at a sample collection site, identity of the subject, identity of the person drawing the subject's sample (phlebotomist), time of departure from the sample collection site, time of arrival at an analytic site, shaking or commotion, as well as temperature and/or humidity in the physical vicinity of the sample container, io wherein said parameter value(s) is/are obtained and managed in a sample container-like sensor and interaction tube, which is brought and kept in physical vicinity of the sample containers during the pre-analytical phase, preferably during collection, storage at the collection site, common transportation to the analytic site and goods receipt at the analytic site.
2. 2. The method of claim 1, wherein said sample container is provided with a spe-cific barcode or OR code.
3. 3. The method of claim 1 or 2, wherein for each sample container one or more information items or parameter values selected from: the sample container identity, the subject's personal data, the phlebotomist's personal data, the origin of the sample, place and time of collection of the sample, sample type, container type, destination of the sample container, filling volume of the sample container, centrifugation status of sample, status of associated a na- lytical order for the sample, or barcode readability of container are regis-tered.
4. 4. The method of claim 3, wherein said registration is performed in a registra-tion scanning device for sample containers and/or in a mobile phone or tablet application.
5. 5. The method of claim 4, wherein the registration of data comprises one or more of (i) registration and verification of a phlebotomist's login to a program which is linked to the registration scanning device for sample containers, preferably in an a mobile phone or tablet application; (ii) registration and identification of the subject via the subject's hospital bracelet; (iii) registra-tion 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 authen- tication application such as scanning of a provided barcode, OR code or im-age, or (viii) registration of a person transporting the sample container(s).
6. 6. The method of claim 5, 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.
7. 7. The method of any one of claims 2 to 6, wherein the sample container-like sensor and interaction tube is virtually linked to the one or more sample con-tainer(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.
8. 8. The method of claim 7, wherein 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.
9. 9. The method of claim 8, wherein the contactless communication is performed via RFID (radio frequency identification), Bluetooth interaction, GSM, LTE, G5, LPWAN, LoRaWAN, or WiFi, preferably Bluetooth.
10. 10. The method of any one of claims 4 to 9, wherein the recorded information items, parameter values and the virtual linkage data are transmitted to a remote computer server system, preferably a cloud-based computer server system, or to a mobile data device, preferably a mobile phone or tablet application.
11. 11. The method of any one of claims 1 to 10, wherein said sensor and interaction tube records said one or more parameter values(s) comprising (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 analytic site once; and (ii) shaking or commotion and temperature and humidity in the physical vicinity of the sample container during the entire collection, common transportation phase, goods receipt at the analytic site and storage at the analytic site.
12. 12. The method of claim 11, 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.
13. 13. The method of claim 11 or 12, where said recording is started upon first contact with a sample container.
14. 14. The method of claim 11 to 13, wherein said recording is terminated upon arrival at an analytic site.
15. 15. The method of any one of claims 1 to 14, wherein said sample container-like sensor and interaction tube delivers all parameter values recorded during the collection and transportation step to a corresponding registration interface io at the analytic site.
16. 16. The method of claim 15, wherein said delivery additionally comprises transmission to and from a remote computer server system, preferably a cloud-based computer server system, or to and from a mobile data device, prefer-ably a mobile phone or tablet application.
17. 17. The method of any one of claims 1 to 16, wherein said analytic site comprises a clinical information system such as a [IS system, a KIS system, a CPOE system, or a KAS system.
18. 18. The method of claim 17, wherein said [IS 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 OR code of a sample container via a cloud-based computer server system automatically or upon initi-ation.
19. 19. The method of any one of claims 15 to 17, 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 separation of said sample container and/or an automatized alert of incoming goods or analytic personal.
20. 20. The method of any one claims 1 to 19, wherein said parameter value is pro-vided in a digitalized form.
21. 21. The method of any one of claims 2 to 20, wherein said barcode or OR code comprises remote database accessory data and optionally one or more of io subject specific data, sample specific data and intended analysis-related data.
22. 22. The method of claim 21, 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.