WO2015170111A1

WO2015170111A1 - Verification method and system

Info

Publication number: WO2015170111A1
Application number: PCT/GB2015/051355
Authority: WO
Inventors: Akshay PEER; Marc Clement
Original assignee: TRAKCEL Ltd
Current assignee: TRAKCEL Ltd
Priority date: 2014-05-09
Filing date: 2015-05-08
Publication date: 2015-11-12
Anticipated expiration: 2016-11-09
Also published as: GB201408251D0; GB2526264A

Abstract

This invention relates generally to regenerative medicine, and processes for handling, preparation, processing or treatment of biological, therapeutic or medicinal substances for use therein. Such substances may include, for example, tissue, blood, stem cells, bone marrow etc. In particular, the invention provides a mechanism for controlling such a process through novel verification techniques and architectures. By controlling the process which the substance is subjected to, the invention preserves the quality and integrity of the substance, and ultimately protects patient welfare. In order to comply with regulations, and to ensure the quality of the processed substance, it is often important that the process is conducted by an authorised individual and in an authorised location, such as a certain grade of clean room or a specified hospital. The invention requires verification of the individual and their location prior to allowing the predetermined task(s) to be performed in respect of the substance. The invention is particularly suited for, but not limited to, use in autologous or allogeneic therapies.

Description

Verification Method and System

This invention relates generally to regenerative medicine, and the handling, preparation, processing or treatment of biological, therapeutic or medicinal substances for use therein. In particular, it provides a mechanism for controlling the process by which the substance is handled, treated, processed or prepared, through novel verification and control techniques and architectures. By controlling the process which the substance is subjected to, the invention provides the benefit of ensuring the quality of the resulting biological product, and ultimately patient safety. The invention is particularly suited, but not limited to, use in autologous or allogeneic therapies.

Regenerative medicine (RM) is the process of replacing or regenerating human cells, tissues or organs to restore or establish normal function. This field holds the promise of regenerating damaged tissues and organs in the body by replacing damaged tissue and/or by stimulating the body's own repair mechanisms to heal previously irreparable tissues or organs.

Regenerative Medicine also includes the possibility of growing tissues and organs in the laboratory and safely implanting them when the body cannot heal itself. This can potentially solve the problem of the shortage of organs available for donation, and the problem of organ transplant rejection if the organ's cells are derived from the patient's own tissue or cells. RM can be broadly classed into two categories:

1. Autologous: means that the therapy used for treatment is generated from the patient's body i.e. biological samples including bone marrow, blood, etc. are extracted from a given donor and then these samples are processed and administered back to the same donor. The therapy can be used soon after being collected; it can also be frozen, stored and used in the future if needed.

2. Allogeneic: means that the therapy used can be derived from a donor but the recipient can be different from the donor.

Regenerative medicine is enshrined in legislation, as more and more new regenerative medicinal therapies progress through Phase I to Phase III and eventually become commercialised, a need for a technological innovation that ensures a patient receives the correct therapeutic agent becomes imperative to protect against deleterious conditions such as host versus graft disease. In order to comply with FDA and EMA regulations, these therapies must be administered by qualified professionals and ensuring donor/recipient in an controlled environment whilst providing necessary records including cell analysis, weight, tests, etc. and also a record of the 'Chain of custody' as the samples and therapeutic agents move from one facility to the next.

When preparing, handling, treating or processing of tissue, physiological material or medicinal material and the like, it is often necessary to subject the material to stringently controlled conditions. In most cases, it is also necessary to perform various processing stages in a precisely ordered and timely sequence to ensure that the material remains in optimum or viable condition when subsequently administered to a patient. During handling and processing of such materials, they are subjected to various processing steps (typically analytical or preparative), which must be performed at specific or predefined times and/or in a predefined sequence. This is particularly important during the processing of autologous or allogeneic tissue-derived material from a biological sample of the patient to be treated.

In order to preserve and maintain the integrity of the sample or agent, not only must certain tasks be performed only by qualified (authorised) personnel, but they may only be performed in authorised locations. For example, certain tasks may only be performed in a clean room. A cleanroom has a controlled level of contamination that is specified by the number of particles per cubic meter at a specified particle size. Cleanrooms are classified according to the number and size of particles permitted per volume of air. Thus, it is not only important to know who is performing a certain task in relation to a given sample, but where it is being performed. Ideally, tasks should not be allowed to be performed in a location which could compromise the integrity of the sample or agent and thus, ultimately jeopardise the health of the patient.

WO 2012/139090 discloses a mapping arrangement for tracking and identifying vials containing biological samples. The box mapping apparatus comprises a frame for receiving a sample box of RFID-tagged sample vials, and an antenna configured to read the RFID tags so that the identify and location of each vial can be determined. This facilitates access and retrieval, so that a particular vial can be located more easily and in less time. However, WO 2012/139090 does not teach any solution for ensuring that the contents of the vials are processed by appropriate personnel in an appropriate location.

US 2013/0127616 discloses a method and system for monitoring the presence of individuals at a location, such as students on a school bus. The individual is identified using a code received in a RFID-UHF signal emitted by a tag carried by the individual. A RFID at the location (e.g. on the bus) detects the person as they enter or leave. Data generated as a result is transmitted to a remote server. However, there is no disclosure of ensuring that biological material is processed appropriately and safely by the correct individual and at the correct location.

Methods of tracking physiological samples are known from several prior art documents, such as WO03/042788; WO2008/1 12431, and WO2010/056287.

WO03/042788 describes a series of steps which comprises assigning a unique identifier to a sample, and using a reader to recognise the unique identifier so as to obtain and record time and location data showing when and where the unique identifier has been recognised from the sample. This is a passive system and merely collects information about time and location initially.

WO2008/1 12431 and WO2010/056287 both describe systems to track patient specimens through collection and analysis steps using RFID technology.

WO 2013/117928 and GB 2507019 disclose a method and system for tracking biological samples through a sequence of steps. Data is captured as the sample progresses through the steps, including data relating to the operator handling the sample and the location of the event. However, the location data is captured so as to provide a record of the event that has already taken place, in a posteriori fashion. There is no disclosure of capturing location data a priori for use in verifying whether or not the event should then be allowed to take place, and controlling the sequence of events based upon the results of that location-based verification. The location data is not used to control how the system behaves and thus the steps which are performed on the sample.

US 2009/0012818 discloses a method and system for ensuring that medicines are dispensed to the correct patient. It does not disclose an authentication solution for ensuring that a process or task is performed on a biological sample by an authorised person at an authorised location.

US 2013/0159008 discloses a solution for verifying the location of a visit made by a healthcare worker to a patient. It does not disclose a solution for controlling a process or task performed on a biological sample by ensuring that the process is conducted at the correct location and by an authorised individual.

Thus, while location tracking technologies and authentication techniques are known in various fields, these technologies and techniques have not been brought into combination in relation to processing and preparation of biological samples to ensure their integrity and prevent their deterioration or comprise during their preparation.

Thus, it is desirable to provide a solution which only permits a predetermined processing, treatment, preparation, transactional or handling task to be performed on a biological or therapeutic substance if both the operator and the location have been verified as authorised for that task.

Such an improved solution has now been devised.

The present invention provides systems and corresponding methods as defined in the appended claims. Features described below in respect of one embodiment or aspect of the invention may also be present in any or all other embodiments or aspects of the invention. Therefore, in accordance with a first aspect of the invention there is provided a verification method comprising the step: permitting or enabling the performance of at least one predetermined task in relation to a regenerative medicine substance upon successful verification of an authorised individual and the individual's location. The term 'authentication' may be used instead of 'verification' .

Additionally or alternatively, the method may be described as a method of controlling a process to be performed in relation to a biological substance, the method comprising the step:

requiring successful electronic verification of an individual (e.g. their identity) and the individual's location prior to permitting a pre-determined task to be performed in respect of the substance.

The process may comprise one or more tasks. Both the process and the tasks may be predetermined and associated with the biological sample. The biological sample or regenerative medicine substance may be associated with a particular source (eg a sample donor) and/or a particular recipient (eg patient to receive treatment). Therefore, it may be predetermined that a given sample is associated with a certain process, which may comprise one or more individual tasks, and that those tasks may only be performed by specified authorised individuals and within one or more specified locations. Data relating to the predetermined process/tasks, authorised individuals and/or authorised locations associated with a given sample may be stored on a server. The task(s), process or information relating thereto may only be communicated to or accessible by an authorised individual in an authorised location. Thus, successful verification of the individual and their location enables performance of the process or tasks(s) on the specified sample or substance, and unsuccessful verification prevents performance of the process/task because the individual does not have the necessary information or resource access in order to be able to perform it. The regenerative medicine substance may be any substance or material that is to be used in a regenerative medicine process, therapy or treatment. It may be derived from a human or non human source. The regenerative medicine substance may be a biological sample or therapeutic agent. It may be a medicinal product or any physiological matter. For example, it may comprise blood, tissue, stem cells, bone marrow or a medicinal/therapeutic compound. Hereinafter, for the sake of convenience, it may simply be referred to as the 'sample', 'substance' or 'agent' .

It may be stored in a vial or other container. It may be external to any human body when the pre-determined task is performed on it (following successful verification of location and identity). The individual may be permitted to perform the at least one predetermined task if, and only if, it is verified that the individual is authorised to perform the task and the individual is at an authorised location. The task may be performed by the authorised individual or another individual. For example, an authorised doctor or nurse may verify his or her identity and location but the task may be performed by a trainee under the supervision of the authorised individual at the authorised location.

Preferably, verification of the individual and his location is performed electronically. 'Electronic verification' is intended to mean that the verification process is performed using one or more electronic devices having memory and processing capabilities. The device may be a portable or non-portable computing device. Thus, the invention provides a novel architecture for a verification system.

The step of permitting and/or prohibiting performance of the task may be achieved or implemented in a variety of ways. For example, permission may be provided by allowing access to a controlled resource such as a physical device and/or software system, or to data stored on a computer system or device. Additionally or alternatively, the task may be permitted by transmitting or communicating the one or more tasks to a recipient device - for example, sending the task(s) over a network to a device provided at the location.

Additionally or alternatively, it may be permitted by presenting the one or more tasks on a device e.g. by display on a screen; or it may be permitted by allowing access to a computing device or system. The task may be presented in any suitable form - such as in audible form, or as a video or animation of the actions to be carried out in respect of the substance. Additionally or alternatively, it may be permitted by displaying or transmitting a notification or message indicating that the individual may proceed with the task(s).

Conversely, if verification of the individual and/or his location fails, the individual may be prohibited from proceeding with the process because the invention does not provide the necessary information or resource access to enable performance of the pre-determined task.

Thus, the invention either permits or prohibits performance of the one or more tasks based on both the identity and location of the individual. Therefore, if the individual is authorised (i.e. pre-approved) but not in an authorised location, performance of the task is prohibited. Similarly, if an unauthorised individual is in a correct (i.e. pre-approved) location for performance of the pre-determined task, performance is not permitted.

Thus, the invention provides a control mechanism for controlling where and by whom the regenerative medicine substance may be handled or processed. By ensuring that the substance may only be processed by an authorised individual in an approved location, errors may be reduced or eliminated, thus preserving the integrity of the substance, as well as the health and safety of the ultimate recipient. It also ensures compliance with regulatory requirements. Preferably, verification of the individual and/or location is performed electronically. It may be performed using an electronic device with processing capabilities provided at the location; or it may be performed on an electronic processing device provided remotely from the location. The term 'remote' is used herein to mean physically separate from and is not intended to denote any particular degree of geographical distance.

The method may further comprise the step of:

generating identity data relating to the identity of the individual.

The identity data may take a variety of forms. For example, it may comprise a name and/or password, a PIN or other identifier. The data may be biometric data taken or derived from the individual. The identity data serves to establish the identity of the given individual. The identity data may be generated by capturing data from the individual, the data being captured via manual entry or electronic entry into one or more electronic devices. Thus, the identity data may be received by the electronic entry device via one or more different techniques. For example, the user may manually enter it (e.g. type it in via a mechanical keyboard). Additionally or alternatively, it may be entered via electronic means. For example, it may be spoken by the user and captured via speech recognition software, or may be entered via a touch screen. It may be entered using optical recognition means, or by scanning something with a reading device e.g. a bar code scanner, fingerprint scanner.

The electronic device may be a portable device. It may be a handheld device. It may be a tablet computer, a smartphone or a laptop computer. Additionally or alternatively, it may be a desktop computer. The electronic device may be referred to as an 'input device' or 'entry device' .

The invention is not intended to be limited with regard to the type or format of the identity data, or the means by which it is entered into the electronic input device.

The method may further comprise the step of:

generating location data relating to the current location of the individual.

The location data may be generated by capturing data relating to the current location of the individual, the data being captured via manual or electronic entry into an electronic device, or by automated location sensing means. Thus, as with respect to the identity data, the invention is not intended to be limited with regard to the type or format of the location data, or the means by which it is entered into the electronic input device.

The location data may be generated by the same device used to generate the identity data, or a different device. The location data may be generated by scanning a RFID or barcode label, or quick response code (known as a "QR code"). It may be manually entered as a location name or reference number; or it may be automatically computed using

triangulation techniques which include the use of WiFi, Bluetooth, iBeacon technology, or GPS technology. The location computed by the automatic sensing means may need to lie within a pre-determined geographical area or region in order for it to be deemed as successfully verified. Additionally or alternatively, the data may be input by selection of a location from a list or menu displayed on a screen. Geofencing techniques may also be employed.

The location may be a building, a floor in a building, a room such as a clean room or a laboratory, an operating theatre etc. it may be a city or town. In addition to requiring the verification of the individual's location and identity, the identity of the substance may also need to be successfully verified before performance of the at least one predetermined task may be permitted. The substance may be identified by a barcode label which can be used to provide identification data to a scanning device. The barcode label may be attached to a container which contains the substance. Other forms of technology may be used to uniquely identify the substance, and the invention is not intended to be limited in this regard.

Thus, the method may comprise the step of permitting performance of the at least one predetermined task in relation to the regenerative medicine substance upon successful verification of the authorised individual and the individual's location, and the identity of the substance.

The method may further comprise the step of:

transmitting the identity data and/or the location data to a remote computing resource. The remote computing resource may be cloud-based. The remote computing resource may be a server or centralised computer. The computing resource may comprise software for performing verification of the individual, substance and/or location.

The data may be transmitted via a wired or wireless connection. It may be transmitted via a telecommunications network. It may be transmitted via the internet. It may be encrypted. It may be transmitted from the electronic input device upon which it was entered or computed. It may be transmitted to a remote server for verification thereon.

The method may further comprise the steps of:

comparing the identity data with stored identity data relating to one or more authorised individuals to verify whether the individual is authorised to perform the task.

Thus, an electronic register of authorised individuals may be stored or maintained. The register is a record of authorised individuals. The register may be stored on the remote computing resource. Verification of the individual may be performed by checking the captured identity data provided by the individual against the contents of the register. The register may store authorisation data relating to authorised individuals e.g. PIN, password etc. Thus, successful verification of the individual may be deemed to have occurred if the identity data generated by the input device matches an entry in the register of authorised individuals. If it does not match an entry in the register, verification of the individual is deemed to have failed. The method may further comprise the step of:

comparing the location data with stored location data relating to one or more authorised locations to verify whether the predetermined task may be performed at the current location. As per the identity data, the location data may be verified against an electronic register which stores data relating to authorised (approved) locations. Successful verification of the location may be deemed to have occurred if the location data matches an entry in the location register, and fails otherwise. The stored data relating to the authorised individuals and locations may be linked. For example, an individual may only be authorised to perform a task in some but not all locations. Furthermore, an individual may only be authorised to perform certain tasks, not all task, and/or in relation to certain types of sample or agent. Therefore, an individual may be authorised to perform only one or more specified tasks at one or more approved locations, in respect of specified types of sample or agent. One or more individuals may be mapped to (associated with) one or more pre-determined tasks which have been specified in respect of a particular substance. Therefore, for any given sample, there may be a pre-defined process which it is to undergo, and that process may only be performed by certain specified, authorised individuals and/or within specified, authorised locations. The process, authorised individuals and/or authorised locations relating to a given sample may be stored electronically in a central resource. The process may be determined by a medical practitioner, administrator or other qualified person.

The at least one predetermined task may relate to the processing, manipulation or handling of the regenerative medicine substance. The task may relate to extraction of the substance from a patient or donor; or it may concern the administration of the substance to a patient. It may relate to an allogeneic or autologous process. It may relate to chemical, manual or mechanical processing of the sample or agent.

The task may comprise information or instructions relating to the apparatus that must be used to perform the task. For example, it may comprise instructions to use a pipette of a certain size. The individual may be required to confirm selection and/or use of the specified apparatus eg by scanning a bar code associated with the apparatus.

A plurality of pre-determined tasks may be performed on or in respect of the sample.

These tasks may be required to be performed in a particular, pre-determined order.

Progression to the next task may not be possible if it is determined that a previous, mandatory task has not been successfully completed. Permitting the task to be performed may involve communicating the task or instructions relating to it to the individual, and/or providing access to a controlled resource such as a device or access to information. The at least one predetermined task may be stored in electronic form on a server. The task may form part of a task-list. The at least one predetermined task may relate to custodial transfer of the biological sample or therapeutic agent from one party (e.g. individual) to another. An electronic acknowledgement may be generated when custody of the substance has been transferred from one party to another. An electronic record may be updated to record that custody has been transferred. An alert may be generated in the event that custody of the substance cannot be transferred as a result of unsuccessful verification of identity and/or location.

The method may further comprise the step of:

recording performance data relating to the performance of the one or more predetermined tasks by the individual. Thus, data may be gathered relating to the processing or handling of the substance. This can assist in maintaining a record or history of the substance or the process to which it has been subjected.

The method may further comprise the step:

using the data to generate a report relating to tasks performed in respect of regenerative medicine substance.

Thus, data may be generated and stored to record events relating to performance of the task(s). Such data may include identity data of one or more individuals who have performed at least one step in respect of the sample, location data of one or more individuals, the time at which at least one task was performed and/or any other relevant data. This provides the advantage that a historical record of the substance and its processing can be created and referenced. The authorised individual may be a technician or operative authorised to process or handle the regenerative medicine substance, or a patient authorised to receive or donate the regenerative medicine substance. The authorised individual may be someone who is authorised to take, transfer or possess custody of the sample. The individual may be authorised to take, transfer or possess custody of the sample on behalf of another party such as an organisation. The method may further comprise the step of:

repeating the verification of the individual and the location.

Thus, the individual may need to verify his identity and/or location more than once. The subsequent verifications may be requested after a predetermined period of time has elapsed, or before a subsequent task may be performed.

The method may further comprise the step of:

requiring successful verification of a further individual and the further individual's location prior to enabling performance of the pre-determined task. For example, both an approved technician and a specified patient may need to be verified at a given location before a certain task may be performed. Alternatively, an authorised technician may only hand over custody of a regenerative medicine substance to an authorised carrier for transfer of the substance to a different location.

The method may further comprise the step:

generating a notification upon unsuccessful verification of the individual.

Thus, the method provides an improved notification system. The notification may be an alert or alarm. It may be provided in visual or audible form. The notification may be provided to the individual, or to a system administrator or another party. The notification may be transmitted to a remote party. It may be transmitted wirelessly. Thus, the notification draws attention to the fact that a verification of an individual and/or location has failed in respect of a particular task.

Also in accordance with the invention, there is provided a verification system comprising one or more computing resources for performing the method described above. Thus, the features described above in respect of the method may also be applicable to the

corresponding system which implements the method.

There may be provided a computer-implemented verification system arranged to enable (permit) performance of at least one predetermined task in relation to a (particular) regenerative medicine substance upon successful verification of an authorised individual and the individual's location.

Additionally or alternatively, the invention may be defined as a control system arranged to control a process to be performed in relation to a biological substance, the system comprising:

hardware and software arranged to require successful electronic verification of an individual and the individual's location prior to enabling or permitting a pre-determined task to be performed in respect of the substance.

The system may comprise:

one or more electronic devices for generating:

identity data relating to the identity of the individual, and

location data relating to the current location of the individual;

the one or more devices being arranged to generate the data via manual entry or electronic entry.

The device(s) may be in communication with one or more computing resources which comprise software arranged to execute and/or facilitate the verification process (of the individual's identity and/or location). This may be wireless communication.

The system may comprise a remote computing resource for storing the data generated by the one or more electronic devices. The resource may be remote from the location and/or electronic device. The computing resource may be cloud-based.

The system may be arranged to enable transmission of the identity data and/or the location data to the remote computing resource.

In addition to requiring the verification of the individual's location and identity, the identity of the substance may also need to be successfully verified before performance of the at least one predetermined task may be permitted. The substance may be identified by a barcode label which can be used to provide identification data to a scanning device. The barcode label may be attached to a container which contains the substance. Other forms of technology may be used to uniquely identify the substance, and the invention is not intended to be limited in this regard. Thus, the system may be arranged to permit (enable) performance of the at least one predetermined task in relation to the regenerative medicine substance upon successful verification of the authorised individual and the individual's location, and the identity of the given substance. The system may be arranged to:

compare the identity data with stored identity data relating to one or more authorised individuals to verify whether the individual is authorised to perform the pre-determined task. The system may be arranged to:

compare the location data with stored location data relating to one or more authorised locations to verify whether the predetermined task may be performed at the current location. The at least one predetermined task may relate to the processing, manipulation, custodial transfer or other handling of the regenerative medicine substance.

The individual may be able to perform the at least one predetermined task if, and only if, the system verifies that the individual is authorised to perform the task and the individual is at an authorised location. Thus, performance of the task may be prohibited upon failure of the verification of the individual's identity and/or location.

The at least one predetermined task may be stored in electronic form on a server. The at least one predetermined task may relate to custodial transfer of the regenerative medicine substance. The transfer may be from one party to another. The system may be arranged to:

store performance data relating to the performance of the one or more predetermined tasks by the individual or another individual. The system may be arranged to:

use the data to generate a report relating to tasks performed in respect of the regenerative medicine substance.

The authorised individual may be a technician or operative authorised to process or handle the regenerative medicine substance, or a patient authorised to receive or donate the regenerative medicine substance.

The location may be successfully verified if it is determined to be a location which has been pre-determined as being an appropriate location where the pre-determined task may be performed relation to the regenerative medicine substance.

The system may be arranged to:

repeatedly require the verification of the individual's identity and the individual's location. The system may be arranged to:

require successful verification of a further individual's identity and the further individual's location prior to permitting performance of the pre-determined task.

Preferably, the system is arranged to generate a notification upon unsuccessful verification of the individual. Thus, the system may be said to provide an improved notification, alert or alarm.

In accordance with another aspect of the present invention there is provided a computer- implemented verification method comprising the steps of:

recording a transfer of custody of a regenerative medicine substance from a first individual to a second individual if the identity and location of the first and/or second individual have been successfully verified. Thus, the identity and location of one, other or both individuals may need to be

successfully verified in order for the transfer of custody to be recorded. The identity of the substance may also need to be successfully verified prior to recording transfer of custody.

Thus, the method may be referred to as a 'control method' because it controls the transactional process. It controls whether or not the substance can be transferred from one party to another. Custody of the substance may be transferred in physical terms (i.e. a vial containing a sample is handed over to a courier or to another technician) and/or logical (e.g. legal ownership and/or liability of the sample).

Transfer of the substance may be performed if, and only if, the respective locations and identities of all involved parties have been successfully verified. The method may include the step of requiring the first and second individuals to provide data relating to their respective locations and identities, and then using this data to perform a verification process upon the identity /location related data. Features described above in relation to other embodiments and aspects of the invention may also be applicable to this aspect of the invention, but are not repeated here for the sake of clarity.

This aspect of the invention may be beneficial in situations where a controlled transaction needs to occur in respect of the substance, such as transfer of custody of the substance from one party to another. In such cases, it is important to ensure that the substance is handed from one authorised individual or party to another authorised individual or party, and that both are in an authorised location. They may be in the same location or separate locations, but the location and identities of both individuals must be verified before the transaction is allowed to be performed. This may enable a chain of custody to be recorded in respect of the substance. It may also ensure the quality of the substance because it requires the respective identities and locations all parties to be authenticated in order for the transfer to take place. Thus, this aspect of the invention reduces or eliminates the likelihood of an erroneous transfer being performed. As a result, patient safety is safeguarded, as an improved regenerative medicine substance is provided.

The method may further comprising the steps of:

capturing identity data and/or location data relating to the first individual using one or more electronic devices;

capturing identity data and/or location data relating to the second individual using one or more electronic devices. The electronic devices may be portable, mobile and/or handheld devices. As described above, the identity data may relate to the identity of the individual. The location data may relate to the current location of the individual. The data may be captured via manual or electronic entry into the electronic device, or by automated sensing means.

The identity data, location data and electronic device(s) may be of the form described above. The first and second individuals may enter their respective data via the same or different electronic devices.

The method may further comprising the step of:

updating an electronic record to indicate that custody of the regenerative medicine substance has been transferred from the first to the second individual.

The method may comprise the step of:

providing an acknowledgement that custody of the substance has been transferred from the first individual to the second individual.

The acknowledgement may be displayed on a screen and/or other presentation device. It may take the form of a system update. It may be transmitted from one device to another. Thus, there may be a system-level acknowledgement that the transfer has taken place e.g. when an electronic record is updated. Additionally or alternatively, the transfer may be acknowledged at an individual level e.g. by informing one or more individuals that verification has been successful and that the transfer is permitted and/or has been performed. The acknowledgement may include the time of the transfer, as well as other data relating to the first/second individuals. Thus, the acknowledgement can provide a chain-of-custody for the substance, and provide assurance that the substance has been subjected to the appropriate process at the right time, by the right people, in the right location.

The method may further comprising the step of:

generating a notification if the identity or location of the first or second individual is not successfully verified.

Thus, the system may generate an alert or alarm when verification fails. Thus, if one or both of the individuals is in an incorrect (non-authorised) location, or their identity cannot be successfully verified, the verification method fails. This situation may be notified to the first and/or second individuals. Additionally or alternatively, it may be notified to another party such as a system administrator. The other party may be located remotely from the first and/or second individuals. The notification may be presented via a screen or other device. It may be transmitted via wired or wireless means. It may include an audible or colour coded notification. This notification ensures that potentially dangerous situations are brought to the attention of personnel who are responsible for the substance e.g. operatives, managers etc.

The method may further comprising the step of:

transmitting identity data and/or location data relating to the first and/or second individual from at least one electronic device to a remote computing resource. Verification of the identity and/or location data may be performed at the remote computing resource. Additionally or alternatively, it may be performed on one or more of the electronic devices. The remote computing resource may store the identity and/or location data relating to the first and/or second individual. Other data may also be stored, such as the time the identity/location data was captured and/or transmitted.

Successful verification of an individual's identity and/or location may be deemed to be established if the data captured using the at least one electronic device matches pre-stored data relating to one or more authorised individuals and/or locations. As described above, one or more electronic registers of authorised individuals and/or locations may be stored or maintained. A corresponding system may also be provided to perform these method steps. Thus, according to this aspect of the invention there may be provided a computer-implemented verification system comprising:

software arranged to record a transfer of custody of a regenerative medicine substance from a first individual to a second individual if the identity and location of the first and/or second individual have been successfully verified.

Thus, the identity and location of one, other or both individuals may need to be

successfully verified in order for the transfer of custody to be recorded. The system may comprise various hardware devices arranged to perform various functions by the execution of suitably arranged software. The system may be arranged to perform verification of the first and/or second individual's identity and/or location prior to recording the transfer of custody of the substance. Identification of the substance may also be required. The system may comprise:

one or more electronic devices arranged to capture identity data and/or location data relating to the first individual;

one or more electronic devices arranged to capture identity data and/or location data relating to the second individual.

These electronic devices may be as described above.

The software may be arranged to update an electronic record to indicate that custody of the regenerative medicine substance has been transferred from the first to the second individual. The electronic record may be part of a database. The database may be stored on a server.

The system may be arranged to:

provide an acknowledgement that custody of the substance has been transferred from the first individual to the second individual.

The system may be arranged to:

generate a notification if the identity or location of the first or second individual is not successfully verified.

The system may be arranged to:

transmit identity data and/or location data relating to the first and/or second individual from at least one electronic device to a remote computing resource. Successful verification of an individual's identity and/or location may be deemed to be established if the data captured using the at least one electronic device matches pre-stored data relating to one or more authorised individuals and/or locations. Thus one or more electronic registers may be maintained, storing data relating to authorised individuals and/or locations.

Any or all embodiments of the invention may comprise a cloud-based approach to verification. Systems of the invention may comprise a cloud-based computing resource (server or database) which is in communication with the electronic devices used by the one or more individuals for verification purposes. The cloud based resource may perform at least part of the verification process in respect of identity, sample and/or location. Upon successful verification, the cloud based resource may provide access to one or more pre- determined tasks, and/or data. Data generated or captured during the verification process may be stored in the cloud. Data relating to performance of the task(s) may be stored in the cloud.

Thus, from one perspective it may be said that all embodiments and aspects of the invention solve the problem of ensuring that the integrity and quality of a biological sample is maintained. It achieves this via the provision of novel methods and system architectures which may involve verification tools and techniques to enforce predetermined criteria relating to the appropriate handling or processing of a particular biological sample.

Thus, the invention may provide an improved biological sample or regenerative medicine substance because potential errors which could otherwise degrade the quality of the sample are prevented and avoided. If the (at least) two-factor verification process fails, the system does not enable the individual to perform the task.

These and other aspects of the present invention will be apparent from and elucidated with reference to, the embodiment described herein.

An embodiment of the present invention will now be described, by way of example only, and with reference to the accompanying drawings, in which: Figure 1 illustrates an illustrative use of the invention, in which the individual logs or administers a blood sample from a donor.

Figure 2 illustrates an illustrative use of the invention, in which the chain of custody of the regenerative medicine substance is controlled by verifying the identity and location of both parties.

Figure 3 illustrates one way in which the invention may be implemented. The invention provides a mechanism for controlling a process to which a regenerative medicine substance ('sample') may be subjected. It can be used to advantage in a variety of situations, three of which are provided for illustrative purposes below.

Scenario 1: Logging or administering a blood sample from a donor:

In the scenario illustrated in figures 1 and 3, a sequence of pre-determined steps must be completed before the system will authorise access to allow the completion of one or more tasks. These steps are described as follows.

1. Verify that the user 1 is authorised to handle/process the given sample and perform tasks relating to it: the user's identity is verified e.g. by requiring the user to log into a computer-implemented system (101). This log in process may comprise password- based user verification, use of an RFID card, or capture of biometric verification data (fingerprint, voice, iris and others), or a combination of these techniques. Input may be received from the user via an electronic input device 4 such as a scanner, desktop computer, laptop, smartphone etc. The data may be sent via the internet, a local communications channel or a telecommunications network 3 to a server or cloud based resource 2.

2. Verify the location that the user is currently in (102): Sample collection tasks may only be authorised in specific locations or environments (operating theatres or treatment wards etc.). In such cases, the computing device could require GPS validation or "swiping" across a fixed transmitter such as iBeacon, Bluetooth, RFID or barcode enabled reader;

3. Verification of a patient as correct donor or recipient: this would require donor verification using one of, or a combination of, barcode label, RFID label or biometric recognition using fingerprint, iris or other similar technologies.

Only after successfully verifying that the correct user is in the correct location in Steps 1 and 2, would the system authorise the logging of the sample against the patient's data records and additional options such as shipping arrangements, lab booking, etc. In other words, the user 1 is only able to perform the predetermined tasks (103) on the sample once his identity has been verified (101) and his location (102). If the user is not authorised to handle the given sample, or is not in the right location, the system prevents access to the information, software resources and/or devices required for performance of the task(s). The identity of the sample may also be verified e.g. by scanning a barcode attached to a vial containing the sample. Upon successful verification, the user 1 may be provided with access to a task list and/or a 'pick list' specifying the apparatus to be used for processing the substance.

Once the tasks have been carried out, the user logs out of the system (105). The user may generate a report (104) comprising information relating to the performance of the task(s). The report may be transmitted to the central computing resource 2.

In the event that the user 1 is not in the correct location or is not specified to be in a given location during system set-up, the system 2 will not let the user 1 access his/her task list and will not allow the user to carry out any tasks until the correct user is in the correct location.

Scenario 2: Cell processing in a clean room or other regulated environment:

In this scenario, a range of verification steps must be completed before the system 2 will authorise access to the required resources and related computing tasks.

1. Verify that a user 1 is authorised to perform the cell processing tasks and log into the system (101): this could be a combination of user login verification (password based), RFID card, or biometric verification (fingerprint, iris and others)

2. Verify the user is in the correct location (102): A cell processing task may only be authorised in specific locations or environments (grade Ά, B or C clean rooms). In such cases, the computing device would require GPS validation or "swiping" across a fixed transmitter such as iBeacon, Bluetooth, RFID or barcode enabled reader.

3. Verification of sample: this would require sample verification using one or a combination of barcode, RFID or other labelling techniques. The biological sample or therapeutic agent is verified by scanning the RFID, barcode or similar label which has a unique identification code attached to each biological sample. Once Steps 1, 2 and 3 are complete and verified successfully, the system authorises the processing of a given biological sample (103). The system must ensure that a qualified user is in the pre-defined location before permitting the user (individual) to process a certain type of biological sample/therapeutic agent. Processing of certain cells must be carried out in validated clean rooms which might be of different Grades A, B or C. A user is required to verify his/her identity, his/her location and the identity of the sample/therapeutic agent to progress to the next stage. If one of these does not match the pre-defined, pre-stored information, the system 2 will not let the user undertake any further tasks and will raise an alarm for the system administrator.

Scenario 3: Maintain 'Chain of Custody'

In the scenario illustrated in Figure 2, custody of a biological sample/therapeutic agent is transferred from one organisation (or one user) la to another lb. To ensure the integrity of the sample, a record of 'Chain of Custody' must be maintained for every biological sample.

Verify that a user la is authorised to perform the cell processing tasks and log it into the system (101) - this would be a combination of user login verification (Password based), RFID card, or biometric verification (fingerprint, iris and others);

Verify that a user (the transferring party) la is in the correct location (102): A cell processing task may only be authorised in specific locations or environments (grade Ά, B or C clean rooms). In such cases, the computing device would require GPS validation or "swiping" across a fixed transmitter such as iBeacon, Bluetooth, RFID or barcode enabled reader.

Verification of sample: this would require sample verification using one or a combination of barcode, RFID or other labelling techniques. The biological sample or therapeutic agent is verified by scanning the RFID, barcode or similar label which is a unique identification code attached to each biological sample

Identify the other user (the receiving party) lb: When transferring custody of samples or therapeutic agents between users la, lb the system 2 may prompt the first user la to capture the details of the second user lb who is accepting custody of the sample. This may be performed by logging their details in the mobile device through a username/password, RFID card swiping or barcode label swiping (with password), or biometric recognition based techniques. Once both users have been verified the system will record their identities, the identifier of the sample being transferred, and the location the sample was transferred from User la to User lb i.e. where the transfer took place.

Therefore, the invention provides a mechanism for determining and/or recording where and when the legal and/or physical ownership, custody and/or liability of the sample(s) has transferred from one party to another.

It should be noted that the above-mentioned embodiments illustrate rather than limit the invention, and that those skilled in the art will be capable of designing many alternative embodiments without departing from the scope of the invention as defined by the appended claims. In the claims, any reference signs placed in parentheses shall not be construed as limiting the claims. The word "comprising" and "comprises", and the like, does not exclude the presence of elements or steps other than those listed in any claim or the specification as a whole. In the present specification, "comprises" means "includes or consists of and "comprising" means "including or consisting of. The singular reference of an element does not exclude the plural reference of such elements and vice-versa. The invention may be implemented by means of hardware comprising several distinct elements, and by means of a suitably programmed computer. In a device claim enumerating several means, several of these means may be embodied by one and the same item of hardware. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be used to advantage.

Claims

-1-

CLAIMS:

1. A computer- implemented verification method comprising the step:

permitting performance of at least one predetermined task in relation to a regenerative medicine substance upon successful verification of an authorised individual and the individual's location.

2. A method according to claim 1 and further comprising the step of:

generating identity data relating to the identity of the individual;

preferably wherein:

the identity data is generated by capturing data from the individual, the data being captured via manual entry or electronic entry into one or more electronic devices.

3. A method according to claim 1 or 2 wherein:

permitting performance of at least one predetermined task comprises enabling the individual access:

information and/or instructions relating to the task; and/or

a controlled resource such as data, computer hardware and/or software. 4. A method according to any preceding claim and comprising the step of:

generating location data relating to the current location of the individual.

5. A method according to claim 4 wherein the location data is generated by capturing data relating to the current location of the individual, the data being captured via manual or electronic entry into an electronic device, or by automated location sensing means.

6. A method according to claims 2 to 5 and further comprising the step of:

transmitting the identity data and/or the location data to a remote computing resource.

7. A method according to claims 2 to 6 and further comprising the steps of:

comparing the identity data with stored identity data relating to one or more authorised individuals to verify whether the individual is authorised to perform the task. 8. A method according to claims 4 to 7 and further comprising the steps of:

comparing the location data with stored location data relating to one or more authorised locations to verify whether the predetermined task may be performed at the current location. 9. A method according to any preceding claim wherein:

the at least one predetermined task relates to the processing, manipulation or handling of the regenerative medicine substance.

10. A method according to any preceding claim wherein:

the individual is permitted to perform the at least one predetermined task if, and only if, it is verified that the individual is authorised to perform the task and the individual is at an authorised location.

11. A method according to any preceding claim wherein the at least one predetermined task is stored in electronic form on a server.

12. A method according to any preceding claim wherein the at least one predetermined task relates to custodial transfer of the regenerative medicine substance. 13. A method according to any preceding claim and further comprising the step of:

recording performance data relating to the performance of the one or more

predetermined tasks by the individual.

14. A method according to claim 13 and further comprising the step:

using the data to generate a report relating to tasks performed in respect of the regenerative medicine substance. -3-

15. A method according to any preceding claim wherein the authorised individual is a technician or operative authorised to process or handle the regenerative medicine substance, or a patient authorised to receive or donate the regenerative medicine substance.

16. A method according to any preceding claim wherein the location is successfully

verified if it is determined to be a location which has been pre-determined as being an appropriate location where the pre-determined task may be performed relation to the regenerative medicine substance.

17. A method according to any preceding claim and further comprising the step of:

repeating the verification of the individual and the location.

18. A method according to any preceding claim and further comprising the step of:

requiring successful verification of a further individual and the further individual's location prior to permitting performance of the pre-determined task.

19. A method according to any preceding claim and further comprising the step:

generating a notification upon unsuccessful verification of the individual.

20. A verification system comprising one or more computing resources for performing the method of any preceding claim.

21. A computer- implemented verification system arranged to permit performance of at least one predetermined task in relation to a regenerative medicine substance upon successful verification of an authorised individual and the individual's location.

22. A system according to claim 21 and comprising:

one or more electronic devices for generating identity data relating to the identity of the individual, and location data relating to the current location of the individual, the one or more devices being arranged to generate the data via manual entry or electronic entry. -4-

23. A system according to claim 21 or 22 and further comprising a remote computing resource for storing the data generated by the one or more electronic devices. 24. A system according to claims 21 to 23 wherein the system is arranged to enable

transmission of the identity data and/or the location data to a remote computing resource.

25. A system according to claims 21 to 24 wherein the system is arranged to:

compare the identity data with stored identity data relating to one or more authorised individuals to verify whether the individual is authorised to perform the predetermined task.

26. A system according to claims 21 to 25 wherein the system is arranged to:

compare the location data with stored location data relating to one or more authorised locations to verify whether the predetermined task may be performed at the current location.

27. A system according to claims 21 to 26 wherein:

28. A system according to claims 21 to 27 wherein:

the individual is permitted to perform the at least one predetermined task if, and only if, the system verifies that the individual is authorised to perform the task and the individual is at an authorised location.

29. A system according to claims 21 to 28 wherein the at least one predetermined task is stored in electronic form on a server.

30. A system according to claims 21 to 29 wherein the at least one predetermined task relates to custodial transfer of the regenerative medicine substance. -5-

31. A system according to claims 21 to 30 wherein the system is arranged to:

store performance data relating to the performance of the one or more predetermined tasks by the individual.

32. A system according to claims 21 to 31 wherein the system is arranged to:

A system according to claims 21 to 32 wherein the authorised individual is a technician or operative authorised to process or handle the regenerative medicine substance, or a patient authorised to receive or donate the regenerative medicine substance. 34. A system according to claims 21 to 33 wherein the location is successfully verified if it is determined to be a location which has been pre-determined as being an appropriate location where the pre-determined task may be performed relation to the regenerative medicine substance. 35. A system according to claims 21 to 34 wherein the system is arranged to:

repeatedly require the verification of the individual and the individual's location.

36. A system according to claims 21 to 35 wherein the system is arranged to:

require successful verification of a further individual and the further individual's location prior to permitting performance of the pre-determined task.

37. A system according to claims 21 to 36 wherein the system is arranged to:

generate a notification upon unsuccessful verification of the individual. 38. A method of controlling a process to be performed in relation to a biological

substance, the method comprising the step:

requiring successful electronic verification of an individual and the individual's -6- location prior to permitting a pre-determined task to be performed in respect of the substance.

A control system arranged to control a process to be performed in relation to a biological substance, the system comprising:

hardware and software arranged to require successful electronic verification of an individual and the individual's location prior to permitting a pre-determined task to be performed in respect of the substance. 40. A computer-implemented verification method comprising the steps of:

recording a transfer of custody of a regenerative medicine substance from a first individual to a second individual if the identity and location of the first and/or second individual have been successfully verified. 41. A method according to claim 40 and further comprising the step of:

capturing identity data and/or location data relating to the first individual using one or more electronic devices; and/or

capturing identity data and/or location data relating to the second individual using one or more electronic devices;

42. A method according to claim 40 or 41 and further comprising the step of:

A method according to claim 40 to 42 and further comprising the step of:

44. A method according to claim 40 to 43 and further comprising the step of:

45. A method according to claim 40 to 44 and further comprising the step of:

transmitting identity data and/or location data relating to the first and/or second individual from at least one electronic device to a remote computing resource.

A method according to claim 41 to 45 wherein successful verification of an individual's identity and/or location is established if the data captured using the at least one electronic device matches pre- stored data relating to one or more authorised individuals and/or locations. 47. A computer-implemented verification system comprising:

software arranged to record a transfer of custody of a regenerative medicine substance from a first individual to a second individual if the identity and location of the first and/or second individual have been successfully verified. 48. A system according to claim 47 and further comprising:

one or more electronic devices arranged to capture identity data and/or location data relating to the first individual; and/or

49. A system according to claim 47 or 48 wherein the software is arranged to update an electronic record to indicate that custody of the regenerative medicine substance has been transferred from the first to the second individual. 50. A system according to claim 47 to 49 wherein the system is arranged to:

51. A system according to claim 47 to 50 wherein the system is arranged to:

generate a notification if the identity or location of the first or second individual is not successfully verified. A system according to claim 47 to 51 wherein the system is arranged to:

transmit identity data and/or location data relating to the first and/or second individual from at least one electronic device to a remote computing resource.

A system according to claim 48 to 52 wherein successful verification of an

individual's identity and/or location is established if the data captured using the at least one electronic device matches pre- stored data relating to one or more authorised individuals and/or locations.