Systems and methods of sample management

Abstract

There is proposed a method and system for providing a sample management system, including a primary module for sample collection and handling, an employee module and a plurality of employer modules. The primary module comprising a sample collection component, a sample transport component and a sample testing component, configured to track the location and authenticity of an individual sample of an employee to confirm a chain of custody. The employee module in communication with the primary module and configured to control input of personal data, and store test result data relating to the individual sample, the employee module furthermore configured to control permission relating to granting access to the personal data and / or the stored test result data, for a number of employers or potential employers via respective employer modules.

Description

[0001] SYSTEMS AND METHODS OF SAMPLE MANAGEMENT

[0002] FIELD OF THE INVENTION

[0003] The present invention relates to a systems and methods of sample management and in one aspect relates to providing a chain of custody for a drug test or other medical test. The invention could also, in other aspects, relate to a chain of custody for a biological, environment or chemical test / sample.

[0004] BACKGROUND OF THE INVENTION

[0005] Pre-Employment medicals are becoming increasingly more common as part of the employment landscape. This legal, medical and employment event is time consuming, costly and involves an extended number of stakeholders.

[0006] Companies typically require up-to-date medically and legally compliant preemployment test data. As a result, the industry is turning to digitisation as a solution to streamline the process, protect patient and employee privacy even in siutuations where an employees works across multiple organisations. In some cases, a candidate may need to undertake multiple separate pre-employment medicals for different employers for whom they will be working as a contractor or casual employment.

[0007] Sample management covers all stages of the process, from collection by specialized personnel at designed collection points, to laboratory analysis, and result dissemination. Samples are handled, processed, stored, and transported in accordance with strict protocols to maintain sample integrity. A key component of sample management is the chain of custody (CoC), which documents every instance of sample handling, transfer, and storage. The CoC safeguards samples from unauthorized access or tampering by incorporating crucial elements such as accurate labelling, tamper-evident seals, custodianships, and thorough documentation. Adopting digital CoC systems has further enhanced efficiency by reducing human error, streamlining data entry, and enabling real-time tracking. This ensures the integrity and legal defensibility of the results.

[0008] Drug and alcohol testing is the common application of sample management, especially in workplace settings. It is conducted during pre-employment screenings, promotions, random checks, post-accident investigations, and other situations. Testing can occur on-site, providing immediate results, or be sent to accredited laboratories for comprehensive confirmation and to ensure compliance with regulatory standards.

[0009] Current digital solutions for drug and alcohol testing tend to focus on isolated functionalities such as appointment scheduling or result reporting without providing a comprehensive platform encompassing the entire testing lifecycle. While these solutions have improved certain processes, like random selection testing, result management, and chain of custody tracking, the lack of fully integrated systems presents a significant challenge. Organizations are forced to rely on fragmented tools that handle different stages of the process independently, leading to inefficiencies, increased risks of error, and difficulties in ensuring full regulatory compliance.

[0010] The published prior art includes US Patent Application 2003183683 (STEWART) which disclosed a system for specimen and sample chain of custody tracking, wherein sample specimens, such as biological samples, are collected from the donor at a collection site and transferred to a transport container which includes RFID medium for carrying the chain of custody information generated at the collection site. The electronic signature of the donor and / or collector is captured to verify the chain of custody information and is included in the RFID medium record.

[0011] Another prior art document, US Patent Application 2013268450A1 (MURRAY et al), discloses a method of securing a chain of custody of a specimen of a donor, which includes providing a tamper evident seal operable to indicate that an assaying device has been tampered with once the seal is sealed.

[0012] International Patent Application PCT / US2007 / 071684 (STEVE et al), teaches an electronic chain of custody systems for use with drug testing. The electronic chain of custody system provides a digitally stored chain of custody record, which enables integration of data from multiple system participants to a digital chain of custody record that obviates the necessity of passing along a conventional paper record. In addition, components of the disclosed invention allow printing the digital record and using data recording devices to record data (e.g., handwriting data) which is added to the digital record.

[0013] The reader should appreciate that the terms sample management, chain of custody, testing lifecycle, and digital solutions used throughout the specification and claims, may include the processes, systems, and protocols used for handling, tracking, verifying, and managing the integrity and compliance of samples in domains like medical diagnostics, drug and alcohol testing, forensic investigations, and research, environmental sample and chemical testing.

[0014] The invention will be described with respect to the chain of custody for a drug test or other medical test, however the skilled addressee will appreciate that the invention could be used in relation to a chain of custody for other biological, environment or chemical tests / samples.

[0015] It should be appreciated that any discussion of the prior art throughout the specification is included solely for the purpose of providing a context for the present invention and should in no way be considered as an admission that such prior art was widely known or formed part of the common general knowledge in the field as it existed before the priority date of the application.

[0016] SUMMARY OF THE INVENTION

[0017] It is an object of the present invention, to provide a system or method that addresses one or more of the problems outlined above associated with the current sample management and chain of custody systems, or at least provide the public with a useful alternative. The foregoing objects should not necessarily be considered as cumulative and various aspects of the invention may fulfil one or more of the above objects.

[0018] The skilled addressee will appreciate that through creating a personalised secure digital medical records (also referred to as a workplace medical passport), which are owned and managed by an employee, they will only need to undertake one examination for use by multiple employers. Accordingly, the medical data from that examination can then be securely shared with prospective future employers.

[0019] Employers can rely on the medical data knowing it has been independently validated and verified. The workplace medical passport, reduces costs, time and ensures real time validation of the medical data required by new employers.

[0020] The invention could broadly be understood to comprise an integrated digital platform and system for drug and alcohol testing as a unified digital solution, designed to streamline and manage the entire testing lifecycle, from sample collection and tracking through laboratory analysis to result reporting and regulatory compliance. In one aspect of the invention, but not necessarily the broadest or only aspect, there is proposed a sample management system, including: a primary module configured to manage sample collection, sample transfer and sample testing, the primary module providing chain of custody verification for a sample; and a number of secondary modules configured to communicate with the primary module for receiving sample related data, wherein each of the number of secondary modules being adaptable to receive selected sample related data or input corresponding data based on the status of a corresponding user of the secondary module.

[0021] The corresponding user may be an employee or an employer.

[0022] In another aspect of the invention there is proposed a sample management system, including: a primary module comprising a sample collection component, a sample transport component and a sample testing component, each of the components permitting selectable input of sample date and access thereto by authorised parties to validate and track the location and authenticity of an individual sample of an employee to confirm a chain of custody; an employee module in communication with the primary module and configured to control input of personal data, and store test result data relating to the individual sample, the employee module furthermore configured to control permission relating to granting access to the personal data and / or the stored test result data, for a number of employers or potential employers; and a plurality of employer modules in communication with the primary module for accessing personal data and / or test result data corresponding to the employee, wherein the respective access of each of the plurality of employer modules is based on permission granted by the employee.

[0023] The invention provides verified test result to a digital platform that is controlled by the employee, wherein authorised employers or potential employers are provided access to the personal data and / or the stored test result data corresponding to the employee.

[0024] The employee module, in one form, is configured to store and archive data relating to multiple tests. This may provide a chronological history of the test results of the employee. The employee module may provide reminders to the employee regarding periodic test requirements. The sample date may include the geographical location of the sample, testing status of the sample and test results.

[0025] The sample collection component may be utilised by a collector, such as but not limited to, a medcial practitioner, the sample transport component may be utilised by a courier, and the sample testing component may be utilised by a laboratory. The sample collection component and sample transport component may permit a digital handshake, and the sample transport component and sample testing component may also permit a digital handshake, to thereby verify a chain of custody of an individual sample.

[0026] In one form, there is proposed a platform that connects all relevant stakeholders, including employers, employees, healthcare providers, couriers, and laboratories, improving workflows, real-time monitoring, and automated compliance processes. The platform preferably maintains the authenticity of the chain of custody through meticulous tracking and verification, offering real-time updates on the status and location of samples, thus ensuring accuracy and transparency throughout the process.

[0027] The system of the present invention is configured to comply with relevant government regulatory standards, to meet legal and medical requirements. The system simplifies the scheduling of drug and alcohol tests, provides status updates, and optimizes workflows, resulting in significant time and cost savings.

[0028] Additionally, the platform ensures the security of health-related data, streamlining employee management and facilitating easy transitions within the system. The platform offers transparency with real-time submission, booking, and tracking features. It enables live online appointment bookings and precise monitoring of each stage, from referral to completion. Providing comprehensive tracking and real-time insights empowers users to accurately monitor turnaround times, has significant benefits.

[0029] The platform provides comprehensive, end-to-end traceability of a sample's lifecycle, ensuring that employers, employees or donors, clinical sites, sample collectors, couriers, and laboratories can monitor and manage every process step. The key stakeholders utilizing this platform include, but are not limited to: medical service providers (drug and alcohol testing clinics, specimen collectors, couriers handling specimen transport), laboratories, employers or clients, and employees or donors

[0030] The sample management platform in one form includes five portals:

[0031] 1 . Sample Management (referred to as ‘Collection Manager’) for drug and alcohol testing clinics and offices;

[0032] 2. Sample Collection (referred to as ‘Collect Assist’) for sample collectors;

[0033] 3. Sample Transportation (referred to as ‘Secure Assist’) for sample couriers;

[0034] 4. Reporting (referred to as ‘Report Assist’) for employers or clients; and

[0035] 5. Employee Portal (referred to as ‘Work Assist’) for employees or donors.

[0036] The platform solution of the present invention utilises the latest encryption, mobile technology, and secure cloud infrastructure to ensure maximum health data privacy, security, compliance, and portability.

[0037] The platform of the present invention may comprise a Frontend, a Backend and IT Infrastructure. The Frontend, may include JavaScript Library for Web Interfaces: This library is used to build the web portal interface for employers and medical providers, offering a secure, responsive, and interactive user experience. The Frontend, may further include Cross-Platform Mobile Development: A crossplatform mobile language used to develop a mobile application that provides a consistent user experience on iOS and Android devices.

[0038] The Backend may include JavaScript Runtime Environment: Serves as the runtime environment for the server-side application, ensuring scalable and efficient handling of requests. The Backend may further include Progressive Framework for Server-Side Development: A progressive Node.js framework for building efficient and scalable server-side applications to structure the backend services and API endpoints.

[0039] The IT Infrastructure may include Serverless Cloud Infrastructure: Deployed using cloud platforms that support serverless functions to achieve high scalability, flexibility, and cost-efficiency. The IT Infrastructure may further include Secure Data Storage: Health data is securely stored in compliance with data protection regulations, with encryption and access controls to safeguard sensitive information. The system may include various Security and Compliance features, including but not limited to, Data Verification, Regulatory Compliance and Encryption and Access Control.

[0040] The Data Verification may include Health data being verified by an independent third party to ensure accuracy and trustworthiness. This process includes validating medical assessments and the integrity of the stored data.

[0041] The Regulatory Compliance may include the system being compliant with relevant country regulatory regimes, such as HIPAA and GDPR. This ensures that all medical data is handled with the highest privacy and security standards.

[0042] The Encryption and Access Control ensure all data in transit and at rest is encrypted using industry-standard protocols, including quantum-safe encryption. Access controls are implemented to ensure that only authorized personnel can access sensitive information.

[0043] The system may include Mobile and Web components. The Mobile component allows Employee Access: the mobile application offers employees a secure medical testing process. The key features include: Secure Storage, wherein health data is securely stored on the device with encryption; Portability and Standardization, wherein employees can easily present their medical data to new employers; and Accessibility, wherein the system offers a secure, user-friendly interface for managing medical information.

[0044] The Web component provides a web portal which offers robust functionality for employees, employers, and medical providers. The system permits: Employee and Employer Access, wherein both employees and employers can log in to the web portals and verify and view employee health data; and Medical Provider Access, wherein the Medical providers can manage medical testing, update medical information, and ensure data accuracy and integrity.

[0045] Various Functions and Features of the system of the present invention (‘Employment Medical Passport”) will be described. The skilled addressee will appreciate that the invention is not limited to these functions and features and others are possible without departing from the scope of the invention. Sample Management

[0046] Sample Management (‘Collection Manager’) for drug and alcohol testing clinics and offices

[0047] Staff and resource management

[0048] The Staff registry may include the features of:

[0049] • Maintain detailed records of staff members, including roles, certifications, and contact details.

[0050] • Automatic notification of certification expirations and renewal reminders.

[0051] The Service registry may include the feature of:

[0052] • Register services offered, with descriptions, prices, collection point locations and associated requirements.

[0053] The Inventory / device management may include the features of:

[0054] • Register all consumables and supplies with descriptions, prices, collection point location, serial numbers and other associated details.

[0055] • Detailed tracking of all consumables and supplies, including serial numbers and usage status and history.

[0056] • Automatic alerts for reorder of supplies when it reaches minimum stock requirements.

[0057] • Maintain detailed records of suppliers.

[0058] The Client (or Employer) management may include the features of:

[0059] • Maintain client database with contact details, authorized representative, locations, service history, and specific requirements.

[0060] • Customizable client profiles for tailored service delivery.

[0061] • Secure portal for clients to access test results and history.

[0062] The Donor (or Employee) management may include the features of:

[0063] • Maintain detailed records of donors, including personal details, health data and testing history.

[0064] • Automated scheduling of tests and notifications for donors.

[0065] • Secure portal for donors to access test results and history.

[0066] The Collector management may include the features of:

[0067] • Send invitation to collectors to join the platform.

[0068] • Track and manage specimen collectors, including schedules, certifications, and performance.

[0069] • Automated scheduling and dispatch of collectors based on availability and proximity. The Courier management may include the feature of:

[0070] • Track and manage couriers, including schedules, certifications, and performance.

[0071] The Laboratory management may include the feature of:

[0072] • Maintain laboratory detail records with contact details, locations, service, and specific requirements.

[0073] Appointment and scheduling

[0074] The Booking system may include the features of:

[0075] • Online and real-time booking of appointments for clients and donors.

[0076] • Collection Site Locator.

[0077] • Book onsite jobs for bulk testing.

[0078] • Book in Clinic appointment with details.

[0079] Job management

[0080] The Job management may include the features of:

[0081] • Create jobs in clinic and onside with associated requirements.

[0082] • Assignment and tracking of tasks or jobs to sample collectors.

[0083] • Reassign, shift and cancel jobs.

[0084] • Real-time updates on job progress and completion.

[0085] Reporting and analyzing

[0086] The Result reporting may include the features of:

[0087] • Automated generation and distribution of test results to relevant stakeholders.

[0088] • Scheduled distribution of the test result and reports.

[0089] • Customizable reporting formats for different stakeholders.

[0090] The Analytics and insights may include the features of:

[0091] • Dashboard view with real-time analytics on operations, and performance metrics.

[0092] • Predictive analytics for identifying trends.

[0093] Financial management

[0094] The Accounting may include the feature of:

[0095] • Integrated accounting module for tracking revenues, expenses, and payments. The Financial reporting may include the feature of:

[0096] • Automated generation of financial reports.

[0097] The Billing and Invoicing may include the features of: • Automated billing and invoicing based on services provided.

[0098] • Availability of payment options such as pay at collection center.

[0099] Integration with other systems

[0100] The Integration with other systems may include the features of:

[0101] • Integration with laboratory information systems (LIMS).

[0102] • Integration with existing financial systems.

[0103] Sample Collection

[0104] Sample Collection (‘Collect Assist’) for sample collectors.

[0105] Account management

[0106] The Onboarding may include the features of:

[0107] • Accept invitation and complete information: credentials, consent forms, training certificates, qualifications, accreditation, industry cards.

[0108] • Manage work schedule, location and other working conditions.

[0109] Job management

[0110] The Job management may include the features of:

[0111] • Create and manage work schedules, accept jobs from sample management portal, maintain patient lists, location details, and job assignments.

[0112] • Clock in and clock out with notes, integrated with payroll systems, with options to add detailed notes or reasons for time adjustments.

[0113] • Create and manage jobs for couriers with chain of custody tracking.

[0114] Conduct sample collection

[0115] The Random selection may include the feature of:

[0116] • Provide an option for random drug test selection with customizable criteria.

[0117] The Chain of custody may include the feature of:

[0118] • Verification of chain of custody at collection points to couriers, including digital signatures, barcode scanning, and timestamped entries.

[0119] The Consent Collection may include the feature of:

[0120] • Collect consent forms and questionnaires with direct input into the system.

[0121] Results Management

[0122] The Results Distribution may include the features of: • Automated and manual generation and distribution of test results to relevant stakeholders, with customizable reporting templates.

[0123] • Prepare non-negative test samples for laboratory submission, including packing, labelling with QR codes, and chain of custody documentation.

[0124] • The use of Artifical Intelligence (Al) to provide real time reporting, patient identity management, medication verification and medical real time voice note translation.

[0125] Courier management

[0126] The Onboarding may include the features of:

[0127] • Send invitations to couriers to join the platform, including integration with third- party logistics providers.

[0128] • Track and manage courier schedules and routes, including detailed courier performance analytics.

[0129] The Assign works may include the features of:

[0130] • Automated scheduling and dispatch of couriers based on availability and proximity

[0131] • Hand over specimens to courier with chain custody.

[0132] • Real-time GPS tracking of couriers, with automated route optimization based on real-time traffic data.

[0133] • Automated alerts for delays and issues during transport, integrated with compliance tracking systems.

[0134] Reporting and Analytics

[0135] The Automated Reporting may include the feature of:

[0136] • Automated generation and distribution of test results to relevant stakeholders, integrated with role-based access control for secure access.

[0137] Analytics Dashboard may include the feature of:

[0138] • Real-time analytics dashboard for monitoring operations, compliance, and performance metrics.

[0139] Integration Capabilities

[0140] The Integration Capabilities may include the feature of:

[0141] • Integration with LIMS (Laboratory Information Management Systems).

[0142] Quality management

[0143] The Training Support may include the feature of: • Integrated user training and onboarding support within the platform.

[0144] The Audit Logs may include the feature of:

[0145] • Comprehensive audit logs for tracking user actions within the system, integrated with compliance and security protocols.

[0146] Sample Transportation

[0147] Sample Transportation (‘Secure Assist’) for sample couriers.

[0148] Onboarding and registration

[0149] The Receive invitation may include the feature of:

[0150] • Receive an invitation from the Sample Collection team to register as a sample courier.

[0151] The Registration may include the features of:

[0152] • Download the courier app and register as a courier.

[0153] • Add credentials: ID, Passport, Consent forms, Qualification, Accreditation,

[0154] Industry cards, etc.

[0155] The Training support may include the feature of:

[0156] • Integrated user training and onboarding support within the platform.

[0157] The Compliance management may include the features of:

[0158] • Ensure compliance with standard operating procedures for specimen transportation.

[0159] • Automatic updates and notifications for changes in relevant regulations and compliance standards.

[0160] Chain of custody (CoC) management

[0161] The Start CoC may include the feature of:

[0162] • Initiate the chain of custody process by scanning the job QR code from the collector.

[0163] The Handover / lntact verification may include the features of:

[0164] • Select the type of handover: standard, express and offline.

[0165] • For express handover, verify the satchel integrity by scanning the barcodes.

[0166] • Scan barcodes of the satchel and security tag to ensure they are intact.

[0167] • Confirm the integrity of the satchel; if intact, proceed to complete handover.

[0168] • If satchel is breached, log the breach and notify the relevant parties.

[0169] • Complete the handover process; the chain of custody is updated and marked as completed. The Delivery may include the feature of:

[0170] • Begin the delivery process to the designated laboratory with digital signatures as proof of delivery at the final destination.

[0171] The CoC documentation may include the features of:

[0172] • Generate and print shipping labels with all necessary details.

[0173] • Maintain a digital record of each custody transfer, including timestamps, GPS locations, and personnel involved.

[0174] The Digital CoC forms may include the feature of:

[0175] • Provide electronic forms for documenting each step of the CoC, signed digitally at each transfer.

[0176] The Tamper-evident may include the features of:

[0177] • Integrate with tamper-evident seals that can be tracked and verified digitally

[0178] • Generate alerts for any inconsistencies or breaches in the CoC.

[0179] • Use GPS to verify and log the exact location of each custody transfer.

[0180] The CoC reports may include the features of:

[0181] • Generate detailed reports of the entire CoC for each sample, including timestamps and location data.

[0182] • Automatically check the CoC against regulatory requirements to ensure compliance.

[0183] The CoC access logs may include the feature of:

[0184] • Maintain detailed logs of who accessed custody chain records and when.

[0185] Courier workflow management

[0186] The Job management may include the features of:

[0187] • Accept and manage jobs assigned through the courier app.

[0188] • Track the real-time location of couriers during the sample transportation process.

[0189] • Utilize GPS to log the exact locations of pick-ups, handovers, and deliveries.

[0190] • Optimize delivery routes to ensure timely and efficient transportation.

[0191] Updates / notifications

[0192] The Status tracking / Notifications may include the features of:

[0193] • Provide real-time status tracking to all stakeholders.

[0194] • Notifications for any issues or delays in the delivery process.

[0195] • Send real-time notifications to relevant stakeholders throughout the delivery process. Mobile access

[0196] The Mobile application may include the feature of:

[0197] • Provide a mobile application for couriers to manage jobs, scan barcodes, track status, and access GPS.

[0198] The Offline access may include the feature of:

[0199] • Enable offline access to essential features, with data synchronization when back online.

[0200] Reporting and analytics

[0201] The Reporting and analytics may include the features of:

[0202] • Maintain a database of customer details, preferences, and delivery history.

[0203] • Generate and distribute reports on courier performance, delivery times, and any breaches.

[0204] • Real-time dashboard for monitoring courier activities, performance, and compliance.

[0205] • Automated documentation of handovers, deliveries, and any incidents during transport.

[0206] Employee Portal - Work Assist

[0207] Employee Portal (‘Work Assist’) for employees or donors.

[0208] Registration

[0209] The Create account may include the features of:

[0210] • Accept invitation and create a secure account with email / phone verification.

[0211] • Complete profiles, including personal details, contact information, and employment status.

[0212] The Input initial medical history may include the feature of:

[0213] • Enter medical history, including past conditions, medications, and allergies, which are used to customize assessments.

[0214] The Consent Management may include the feature of:

[0215] • Digitally review and sign consent forms for drug and alcohol testing and result sharing.

[0216] In clinic testing booking

[0217] The Booking confirmation may include the feature of:

[0218] • Receive a clear and concise notification via the portal and email / SMS, confirming the appointment details. Testing

[0219] The Test tracking may include the feature of:

[0220] • Track the progress of ongoing and completed tests, including scheduled appointments and required follow-ups.

[0221] Results management

[0222] The Result view may include the features of:

[0223] • Access medical test results as soon as they are processed, with notifications sent upon availability.

[0224] • View a chronological history of all test results, including dates and types of tests.

[0225] • QR codes on results can be validated.

[0226] Reporting Portal - Report Assist

[0227] Reporting (‘Report Assist’) for employers or clients.

[0228] Registration

[0229] The Create account may include the features of:

[0230] • Accept invitation and create a secure account with email / phone verification.

[0231] • Complete organizational profile, including company details, departments, and contact persons.

[0232] The Role-based access control may include the feature of:

[0233] • Add and manage authorized users who can access and handle employee health data.

[0234] Employee Management

[0235] The Employee registry may include the features of:

[0236] • Maintain detailed records of employees, including roles, contact details and other associated details.

[0237] • Store and archive employee health documents securely within the portal.

[0238] Online Booking

[0239] The Locate service providers may include the features of:

[0240] • Find and select medical service providers based on preference.

[0241] • Generate a booking link for easy access and scheduling.

[0242] The On-site testing booking may include the feature of:

[0243] • Provide requested services, date and number of donors without donors’ details.

[0244] The In-clinic testing booking may include the features of: Provide requested services, date and donors details.

[0245] Receive notification booking confirmation.

[0246] Results management

[0247] The Result view may include the features of:

[0248] • Access medical test results as soon as they are processed, with notifications sent upon availability.

[0249] • View a chronological history of all test results, including dates and types of tests.

[0250] • Automatic notification of expirations for valid date of testing and renewal reminders.

[0251] Functions and Features of the Entire Platform

[0252] Compliance management

[0253] The Regulatory compliance may include the feature of:

[0254] • Built-in compliance checklists for local and national regulations, standards, and

[0255] SOPs.

[0256] The Regulatory Updates may include the feature of:

[0257] • Automatic updates and notifications for changes in relevant regulations and compliance standards.

[0258] The Compliance reporting may include the features of:

[0259] • Automated generation of compliance reports based on data collected during operations.

[0260] • Customizable reporting formats to meet specific regulatory or client needs, with scheduled or real-time report generation.

[0261] • Automatic report notifications sent to relevant stakeholders.

[0262] Communication

[0263] The Status updates may include the features of:

[0264] • Customizable real-time status updates sent directly to stakeholders via preferred communication channels (e.g., encrypted in-platform, email, SMS).

[0265] • Instant status updates to clinics, laboratories, clients, and donors.

[0266] The Multi-Channel Communication may include the feature of:

[0267] • Support for communication via email, SMS, and in-app messaging.

[0268] The Notifications and alerts may include the features of:

[0269] • Automated notifications for upcoming appointments, including reminders and necessary preparations. • Ability to reschedule or cancel appointments directly through notification links.

[0270] • Automated alerts for approaching deadlines, required actions, or unusual activity detected.

[0271] • Notifications for any issues or delays in collection.

[0272] • User-configurable options for notification preferences (e.g., frequency, type of updates).

[0273] The Multi-channel may include the feature of:

[0274] • Support for communication via email, SMS, and in-app messaging.

[0275] Reporting and Analytics

[0276] The Reporting and Analytics may include the features of:

[0277] • Monitor and analyze key performance indicators (KPIs) and historical trends across portals.

[0278] • Interactive dashboards displaying real-time compliance, performance, and data metrics.

[0279] Data security and privacy

[0280] The Multi-Factor Authentication (MFA) may include the feature of:

[0281] • Implement MFA for all users to enhance security.

[0282] The Secure data handling may include the features of:

[0283] • End-to-end encryption for all donor data storage and transmission.

[0284] • Encrypted communication channels for all internal and external communications.

[0285] • Role-based access controls to ensure only authorized personnel can access sensitive data.

[0286] • Ensured integrity of sample data during collection.

[0287] The Audit Trails may include the features of:

[0288] • Maintain detailed audit trails of all actions taken within the platform, including user access and data changes.

[0289] The invention may include an Automated Online Digital Medical Review Officer (MRO) service. The automated online review process allowing employers, and employees to submit test results for official review by an MRO who then provides a determination. The reader will appreciate that this is useful when an Employee returns a positive result, whereafter the Employer can send the results to the MRO. The Employer may ask the MRO to provide a determination (and a medical certificate, approval or instructions) as to whether the Employee has a problem and / or is able to return to work. This means that staff are not prevented from working, thereby costing the company money or disadvantage the employee.

[0290] The review process may be completely digitised and allow any person using the platform of the present invention to submit a request and have it reviewed by a central group of MROs who will operate virtually. This will dramatically improve service times and provide an end-to-end automated virtual service for employers, employees, health providers, and drug testing agencies.

[0291] The skilled addressee will appreciate that the present invention may untilise Artificial Intelligence (Ai), Machine Learning (ML) and / or Large Language Models (LLM), which may be used to: a. translate in real time medical voice notes into text; b. manage patient identity (scanning and populating fields, verifying the data); c. provide user and platform security; and / or d. deliver insights and actionable intelligence (Large Language Model - LLM) as part of the Reporting Module

[0292] In a preferred form, the method steps are contained within an algorithm of a software program. Therefore, in another aspect of the invention there is proposed a software program for implementing at least some of the steps of the above method.

[0293] The software program may be implemented as one or more modules for undertaking the steps of the present invention on a computer system. The modules can be packaged functional hardware or software units / modules for use with other components or modules. The reader will appreciate that multiple processing units, such as but not limited to, central processing units (CPU) or graphical processing units (GPU) may be used to undertake the steps of the method either at a single or several geographical locations or in a network.

[0294] Relevant application software may be stored in a computer readable medium such as electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, system, device, propagation medium, or computer memory. In one possible embodiment, the system described herein includes hardware coupled to a microprocessor, microcontroller, System on Chip ("SoC"), or any other programmable device. In still another aspect of the invention there is proposed an apparatus for implementing any aspect of the above method. The apparatus may include embedded software or firmware with corresponding hardware that is designed to perform one or more dedicated functions. The apparatus may also include a processor / s and a memory component / s, wherein the data is temporarily stored in the memory component / s, before it is transmitted at predetermined intervals or is interrogated by a device to retrieve the data. The memory component / s may be nonvolatile, flash or cache storage device / s. The processor / s and the memory component / s cooperate with each other and with other components of a computer or computers to perform the functionality described herein. Some of the functionality described herein can be accomplished with dedicated electronics hardwired to perform the described functions.

[0295] Communication between the components or modules of the apparatus may be by way of long-range or short-range networks, such as but not limited to low power radio network, microwave data links, 3G / 4G / 5G telecommunications networks, BLUETOOTH®, BLUETOOTH® Low Energy (BLE), Wi-Fi, LoRa™, NB-IOT, Ethernet, Fibre channel (FC), other types of wired or wireless network, or be connectable to a device that utilises such network / s. Some of the components of the system may be connected by way of a communication device such as, but not limited to, a modem communication path, a computer network such as a local area network (LAN), Internet, or fixed cables. Some aspects of the system may communicate in real time via aforementioned systems for processing of one or more modules at one or more physical location / s while user is interacting with one or more module / s at other physical location / s. The apparatus may utilise cloud servers and may include embedded software or firmware with corresponding hardware that is designed to perform one or more dedicated functions of the present invention.

[0296] The designated software program may be stored in a computer readable medium on a storage device such as a hard drive, a magneto-optical disk drive, CD- ROM, integrated circuit, a radio or infra-red transmission channel between the computer and another device, a computer readable card such as a PCMCIA card, a flash drive or any other of the number of non-volatile storage devices as either standalone devices or as part of a dedicated storage network such as storage area network (SAN). The foregoing is merely exemplary of relevant computer readable mediums and other computer readable mediums may be practiced without departing from the scope of the invention. In another aspect of the invention, there is proposed a Product and Service Ordering system incorporated into the above methods, wherein medical testing devices and service ordering can be undertaken by a Medical Review Officer or other authorised personnel when required, in light of future tests and / or inventory levels.

[0297] BRIEF DESCRIPTION OF THE DRAWINGS

[0298] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate an implementation of the invention and, together with the description and claims, serve to explain the advantages and principles of the invention. In the drawings,

[0299] Figure 1 is a flow chart illustrating the method steps of the platform of one embodiment of the present invention;

[0300] Figure 2 is a flow chart of the Collection Manager workflow of one embodiment of the present invention;

[0301] Figure 3 is a flow chart of the Sample Collection workflow of one embodiment of the present invention;

[0302] Figure 4 is a flow chart of the Chain of Custody by Sample T ransportation Portal of one embodiment of the present invention;

[0303] Figure 5 is a flow chart of the Employee’s Portal Workflow of one embodiment of the present invention;

[0304] Figure 6 is a flow chart of the Employer Portal Workflow of one embodiment of the present invention; and

[0305] Figure 7 is a flow chart of the Online Booking Workflow of one embodiment of the present invention.

[0306] DETAILED DESCRIPTION OF THE ILLUSTRATED AND EXEMPLIFIED EMBODIMENTS

[0307] Similar reference characters indicate corresponding parts throughout the drawings. Dimensions of certain parts shown in the drawings may have been modified and / or exaggerated for the purposes of clarity or illustration.

[0308] Referring to the drawings for a more detailed description, there is illustrated a system and method of providing a chain of custody 10, demonstrating by way of examples, arrangements in which the principles of the present invention may be employed. Turning to Figure 1 , there is illustrated a flowchart of one aspect of the system 10, indicating key components of the sample management platform 12, which are integrated into portals or modules for use by all stakeholders. Figure 1 outlines the integration and coordination across different portals or modules 14, 16, 18 by ensuring that samples are securely collected 20, managed, processed, and transferred 22 with appropriate tracking and reporting at each stage.

[0309] Each portal or modules 14, 16, 18 is designed to cater to the specific needs of the users — employers, medical service providers (testing clinics, sample collectors, sample couriers, and laboratory), and employees — while maintaining the integrity and security of the samples throughout the process.

[0310] Medical service providers manage 24 the entire sample collection process through a comprehensive system that includes sample management 16 (Collection manager), sample collection 20 (Collect assist), sample transfer 22 (Secure assist), and testing result import 30 (integration lab through Lab assist). The sample management portal Collection manager oversees the full range of sample management, from collection 20 (Collect assist) to transportation 22 (Secure assist), ensuring seamless coordination and security at every stage. It also facilitates communication between the employer portal 18 and employee portal 14, enabling the timely and efficient reporting of results. Also, the Sample management portal 16 integrates an online booking system 26, allowing employers to schedule appointments seamlessly.

[0311] The Collection Manager portal 16 manages the Staff Registry, Service Registry, Inventory / Device Registry, Work Schedules, Appointment Booking System, and Order Services and handles results, reports, and accounting. For the working process, once samples are collected, they are verified, barcoded, and recorded in the system. Negative results are inputted and reported in the system directly; nonnegative samples are sent to a certified laboratory 28 for further testing. The chain of custody (CoC) is critical, ensuring that every step, from sample collection to result recording, is meticulously tracked.

[0312] The Employee and Employer Portals 14, 18 interact with the other portals, for instance the collection portal 16 and Lab portal 30, mainly in test scheduling and result management. Employees use the Employee Portal 14, and employers use the Employer Portal 18 to manage their interactions with the system, ensuring that all steps are completed correctly. Overall, the flowchart demonstrates how various stakeholders within the platform — employers, medical providers, and employees — interact through interconnected systems to ensure that sample collection, transfer, analysis, and reporting are handled with precision and compliance. This fully integrated platform allows for streamlined operations, real-time tracking, and secure data management.

[0313] Figure 2, illustrates the workflow for Collection Management 32, detailing the processes from preparing the platform for operation in service management and ensuring that all necessary resources and communications are in place.

[0314] The Collection management 32 includes the following functions and features:

[0315] • Staff Management function 34 includes features such as creating / deleting accounts for staff members, roles-based accesses, and maintaining detailed records such as credentials, certifications, and contact details.

[0316] • Service Registry 36 feature allows users to register services offered and their descriptions, prices, collection point locations, and associated requirements.

[0317] • In Inventory / Device Management 38, all consumables and supplies are registered with details such as descriptions, prices, collection point locations, serial numbers, and other associated information. The system also tracks all consumables and supplies, including serial numbers, usage status, and history. Automatic alerts are triggered for the reorder of supplies when minimum stock requirements are reached, and detailed records of suppliers are maintained.

[0318] • Client (or Employer) Management 40 involves maintaining a client database that includes contact details, authorized representatives, locations, service history, and specific requirements. It also supports customizable client profiles for tailored service delivery and provides a secure portal for clients to access test results and history.

[0319] • Donor (or Employee) Management 42 maintains detailed records of donors, including personal details, health data, and testing history. This section also features automated test scheduling and notifications for donors and provides a secure portal for donors to access test results and history.

[0320] • Collector Management includes sending invitations 44 to collectors to join the platform, tracking and managing specimen collectors' schedules, certifications, and performance, and automating the scheduling and dispatch of collectors based on their availability and proximity.

[0321] • Courier Management 46 tracks and manages couriers, including their schedules, certifications, and performance. • Laboratory Management maintains detailed records of laboratories, including contact details, locations, services, and specific requirements.

[0322] • In Appointment and Scheduling 50, the Booking System allows for online and real-time booking of appointments for clients and donors, provides a sample collection site locator, and offers booking options for on-site appointments for bulk testing by providing just the number of employees to be tested and in-clinic appointments by providing employee’s specific details.

[0323] • Job Management 52 includes creating jobs for clinics and onsite services with associated requirements, assigning and tracking tasks or jobs to sample collectors, and the ability to reassign, shift, or cancel jobs. The system also provides real-time updates on job progress and completion.

[0324] • Reporting and Analyzing functions include features for automated generation and distribution of test results to relevant stakeholders, scheduled distribution of test results and reports, and customizable reporting formats for different stakeholders. Analytics and Insights offer a dashboard view with real-time analytics on operations and performance metrics and predictive analytics for identifying trends.

[0325] • Financial Management 56 includes an integrated accounting module for tracking revenues, expenses, and payments, automated generation of financial reports, and automated billing and invoicing based on services provided. It also offers various payment options, such as payment at the collection center.

[0326] • Integration with Other Systems includes integration with Laboratory Information Systems (LIMS) and existing financial systems, ensuring seamless data flow and operational efficiency.

[0327] Turning to Figure 3 there is illustrated a flowchart of one embodiment for the sample collection 16 (‘Collect Assist’). The primary purpose of the sample collection portal 16 is to provide a streamlined, efficient, and secure platform for managing the collection 20, tracking, and documentation of samples. It ensures that all steps in the sample collection process are accurately recorded and monitored, maintaining the integrity of the samples and compliance with regulatory standards. The portal 16 also facilitates communication and data sharing between stakeholders, such as laboratories, testing clinics or offices, clients, and donors, thereby enhancing transparency and reducing the risk of errors or data loss throughout the sample management process. The Collect Assist portal 16 has the following features:

[0328] • Account Management involves onboarding processes where users accept invitations from the sample management portal and complete necessary information such as credentials, consent forms, training certificates, qualifications, accreditations, and industry cards. It also includes managing work schedules, locations, and other working conditions to ensure users are well- prepared for their roles.

[0329] • Job Management 56 allows for creating and managing work schedules, accepting jobs from the sample management portal, and maintaining patient lists, location details, and job assignments. This includes the functionality for clocking in and out with notes integrated with payroll systems, allowing users to add detailed reasons for time adjustments. Additionally, it involves creating and managing jobs for couriers with chain of custody tracking to ensure the integrity of the process.

[0330] • Conducting Sample Collection 58 includes features providing different randomization methods if random testing is required. Identify donors, consent forms, and questionnaires with direct input into the system. It also ensures the CoC verification at collection points to couriers, including digital signatures, barcode scanning, and timestamped entries. If instant drug test results are nonnegative, it includes preparing samples for transportation to the laboratory for confirmation while maintaining CoC documentation from handling, storing, packing, and labelling with QR codes at the point of collection.

[0331] • Results Management 60 focuses on the automated and manual generation and distribution of test results to relevant stakeholders, with customizable reporting templates.

[0332] • Courier Management involves onboarding couriers by sending invitations to join the platform, including integration with third-party logistics providers. It also includes tracking and managing courier schedules and routes with detailed performance analytics. Assigning work to couriers is automated based on availability and proximity, and real-time GPS tracking is used along with automated route optimization based on real-time traffic data. Alerts for delays and issues during transport are automated and integrated with compliance tracking systems.

[0333] • Reporting and Analytics cover the automated generation and distribution of instant test results and summary reports to relevant stakeholders, with role- based access control for secure access. It also includes a real-time analytics dashboard for monitoring operations, compliance, and performance metrics.

[0334] • Integration Capabilities ensure a seamless connection with LIMS for efficient data flow and operational integration.

[0335] • Quality Management includes training support with integrated user training and onboarding within the platform. Comprehensive audit logs are maintained to track user actions within the system and integrated with compliance and security protocols to ensure the platform meets high standards of operational integrity.

[0336] Figure 4 illustrates the sample transferring process with the CoC of the Secure Assist. The primary purpose of the sample transferring portal is to ensure the secure, accurate, and traceable transfer of samples between different parties while maintaining the integrity and compliance of the CoC process. This portal tracks each sample transfer step, documenting all custody transfers and ensuring the journey is fully transparent and auditable. This helps prevent tampering, loss, or mismanagement of samples and ensures that all legal and regulatory requirements are met, particularly in sensitive or regulated environments such as drug and alcohol testing.

[0337] The main features of a sample transferring with the chain of custody portal includes:

[0338] • Onboarding and registration begin with receiving an invitation from the Sample Collection 62, allowing certified individuals to register as sample couriers. Upon receiving this invitation, couriers download the courier app to complete their registration by providing essential credentials, such as ID, passport, consent forms, qualifications, accreditations, and industry cards. The platform supports integrated user training and onboarding to ensure couriers are well-prepared for their roles. Compliance management is also a key feature, ensuring that couriers adhere to standard operating procedures for specimen transportation, with automatic updates and notifications for relevant regulations and compliance standards changes.

[0339] • CoC management begins by scanning the job QR code 64 provided by the collector at the sample collection site or clinic. It is completed by scanning the QR code at the laboratory. The handover process can be standard, express, or offline, depending on the job requirements. The verification of the integrity of the satchel by scanning the barcodes and security tags step 66 is important, as it confirms that the satchel is intact before proceeding with the handover. If a breach is detected, the courier logs the breach and notifies the relevant parties. Once the handover is completed, the CoC is updated and marked as completed 68. The delivery process begins with digital signatures as proof of delivery at the final destination. The platform also generates and prints shipping labels with all necessary details and maintains a digital record of each custody transfer, including timestamps, GPS locations, and personnel involved. Electronic forms are provided to document each step of the CoC, signed digitally at each transfer. Tamper-evident seals are integrated and can be tracked and verified digitally, with alerts generated for any inconsistencies or breaches in the CoC. GPS is used to verify and log the exact location of each custody transfer. Detailed CoC reports are generated for each sample, including timestamps and location data, and the system automatically checks the CoC against regulatory requirements to ensure compliance. Additionally, detailed logs are maintained to track who accessed custody chain records.

[0340] • Courier management functions include accepting, declining, and managing jobs, tracking real-time location during sample transportation, and utilizing GPS to log the exact locations of pick-ups, handovers, and deliveries. Delivery routes are optimized to ensure timely and efficient transportation.

[0341] • The status update and notification function provide real-time status tracking to all stakeholders, with notifications for any issues or delays in the delivery process. Real-time notifications are sent to relevant stakeholders throughout the delivery process to keep everyone informed.

[0342] • Mobile access is a crucial feature, with a mobile application provided for couriers to manage jobs, scan barcodes, track status, and access GPS. The app also supports offline access to essential features, with data synchronization when the user returns online.

[0343] • Reporting and Analytics functions and features maintain a database of customer details, preferences, and delivery history. They generate and distribute reports on courier performance, delivery times, and breaches. A real-time dashboard is provided for monitoring courier activities, performance, and compliance, with automated documentation of handovers, deliveries, and any incidents during transport.

[0344] Figure 5 illustrates the process employees / donors follow when using the employee portal Work Assist, from initial registration to receiving and managing drug and alcohol testing results. This roadmap ensures that employees / donors have a transparent, guided process for managing their medical testing, from initial registration to receiving and storing their medical results, with consistent communication and reminders.

[0345] The Work Assist portal 14 has the following features:

[0346] • Registration begins with accepting an invitation 70 and creating a secure account 72, including email or phone verification. Once the account is created, the employee completes their profile by entering personal details, contact information, and employment status. The next step involves inputting initial medical history, where the user enters information about past conditions, medications, and allergies, which are used to customize their assessments. Consent Management is also a crucial part of the registration, where users digitally review and sign consent forms for drug and alcohol testing and the sharing of results.

[0347] • In-clinic testing booking features ensure that the employee receives a clear and concise notification via the portal and email or SMS confirming the details of the testing appointment 74. This ensures the donor is fully informed and prepared for their scheduled in-clinic testing.

[0348] • Testing functions and features involve tracking the progress of ongoing and completed tests. This includes monitoring scheduled appointments and required follow-ups, allowing donors to stay on top of their testing process, and ensuring all necessary steps are completed.

[0349] • Results Management 76 allows donors to access their medical test results as soon as they are processed, with notifications to inform them of availability. They can view a chronological history of all test results, including the dates and types of tests conducted. Additionally, QR codes on the results can be validated, providing an extra layer of verification and security for the test results.

[0350] Figure 6 illustrates the Report Assist for Employer roadmap outlining how employers’ access and manage employee health data through the platform. This portal helps employers access reports related to sample testing results, providing them with critical information for decision-making.

[0351] The Report Assist portal 18 has the following features:

[0352] • The Registration process begins with accepting an invitation and creating a secure account 78 that includes email or phone verification. Once the account is created, the organization completes its profile by entering essential details such as company information, department names, and contact persons. In addition, the platform supports Role-Based Access Control, allowing the organization to add and manage authorized users who can access and handle sensitive employee health data.

[0353] • Under Employee Management 80, the system maintains detailed records of employees, including their roles, contact details, and other relevant information. Employee health documents are stored and archived securely within the portal, ensuring that all critical records are managed with the highest level of security and compliance.

[0354] • The Online Booking 82 feature enables employers to locate medical service providers based on their preferences. The system can generate a booking link that allows easy access and scheduling. Employers can provide the required services, date, and number of donors for On-site Testing Booking without inputting donor details. For In-clinic Testing Booking, the system requires employers to provide services, dates, and detailed donor information. After booking, the system sends a notification to confirm the appointment.

[0355] • In Results Management 84, users can access medical test results as soon as they are processed, with notifications sent upon availability. The platform also provides a chronological history of all test results, including the dates and types of tests conducted. Additionally, the system automatically notifies users when the valid testing date is about to expire and sends renewal reminders, ensuring that all testing is kept up to date.

[0356] Figure 7 illustrates the Online Booking roadmap outlining the process for scheduling on-site and in-clinic testing through the employer’s portal. On-site testing begins with the employer providing the requested services and specifying the number of donors. The employer then uses the Report Assist 18 feature to locate a suitable medical service provider 88. Once the provider is selected, the employer agrees to the consent and terms required for the testing 90. The system then generates a booking link 92, which allows the employer to select a date and schedule the appointment. After scheduling, a confirmation is sent to finalize the booking. For Inclinic testing, the process checks whether the employees are already existing users on the platform. If the employees are already registered, they are added to the appointment. If not, an invitation is sent to the employees to join the platform through the Employee portal, enabling them to complete their registration and be included in the testing schedule. This workflow ensures a streamlined and efficient process for employers to manage on-site testing 94 and in-clinic testing 96, with clear steps for locating service providers, scheduling appointments, and confirming bookings 98.

[0357] The skilled addressee will now appreciate the advantages of the illustrated invention over the prior art. In one form the illustrated invention provides a comprehensive digital solution for managing testing samples and reporting results to relevant stakeholders.

[0358] The fragmentation of existing testing regimes underscores the pressing need for an end-to-end solution that integrates all aspects of drug and alcohol testing. The present invention therefore provides a platform which ensure compliance, enhance stakeholder coordination, and integrated workflows.

[0359] Various features of the invention have been particularly shown and described in connection with the exemplified embodiments of the invention, however it must be understood that these particular arrangements merely illustrate the invention, and it is not limited thereto. Accordingly, the invention can include various modifications, which fall within the scope of the invention.

[0360] In the claims which follow and in the preceding description of the invention, except where the context requires otherwise due to express language or necessary implication, the word "comprise" or variations such as "comprises" or "comprising" is used in an inclusive sense, i.e. to specify the presence of the stated features but not to preclude the presence or addition of further features in various embodiments of the invention.

Claims

CLAIMS1. A sample management system, including: a primary module comprising a sample collection component, a sample transport component and a sample testing component, each of the components permitting selectable input of sample date and access thereto by authorised parties to validate and track the location and authenticity of an individual sample of an employee to confirm a chain of custody; an employee module in communication with the primary module and configured to control input of personal data, and store test result data relating to the individual sample, the employee module furthermore configured to control permission relating to granting access to the personal data and / or the stored test result data, for a number of employers or potential employers; and a plurality of employer modules in communication with the primary module for accessing personal data and / or test result data corresponding to the employee, wherein the respective access of each of the plurality of employer modules is based on permission granted by the employee.

2. The sample management system in accordance with claim, wherein authorised employers or potential employers are provided access to the personal data and / or the stored test result data corresponding to the employee.

3. The sample management system in accordance with claims 1 or 2, wherein the employee module is configured to store and archive data relating to multiple tests.

4. The sample management system in accordance with any one of the above claims, wherein employee module provides a chronological history of the test results of the employee.

5. The sample management system in accordance with any one of the above claims, wherein the employee module provides reminders to the employee regarding periodic test requirements.

6. The sample management system in accordance with any one of the above claims, wherein the sample date includes the geographical location of sample, testing status and test results.

7. The sample management system in accordance with any one of the above claims, wherein the sample collection component is utilised by a collector, the sample transport component is utilised by a courier, and the sample testing component is utilised by a laboratory.

8. The sample management system in accordance with any one of the above claims, wherein the sample collection component / sample transport component permit a digital handshake, and the sample transport component / sample testing component permit a digital handshake, to thereby verify a chain of custody of the individual sample.

9. The sample management system in accordance with any one of the above claims, incorporating a medical testing device and service ordering steps which are undertaken by a Medical Review Officer or other authorised personnel.

10. The sample management system in accordance with any one of the above claims, including separate portals for use by different authorised persons.11 . The sample management system in accordance with claims 10 wherein five separate portals.

12. The sample management system in accordance with claims 11 wherein the five separate portals comprise: a sample management portal for use by drug and alcohol testing clinics and offices; a sample collection portal for use by sample collectors; a sample transportation portal for use by sample couriers; a reporting portal for use by employers or clients; and an employee portal for use by employees or donors.

13. The sample management system in accordance with claims 12, wherein an employee or donor utilises the employee portal to authosise access to their test result data by an employer or potential employer.

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