WO2013056296A1

WO2013056296A1 - System and method for test management and reporting

Info

Publication number: WO2013056296A1
Application number: PCT/AU2012/001250
Authority: WO
Inventors: Darron BRIEN
Original assignee: FIT 4 DUTY Pty Ltd
Current assignee: FIT 4 DUTY Pty Ltd
Priority date: 2011-10-17
Filing date: 2012-10-16
Publication date: 2013-04-25
Anticipated expiration: 2014-04-17
Also published as: NZ624793A; AU2012325666A1; AU2012325666B2

Abstract

A computer implemented method of managing a test enables secure, automated test execution and secure, automated processing of test results. The method includes pre-recording test service requirements at a computer server; transmitting a notification of a proposed test to a collector electronic terminal; receiving, from the collector electronic terminal, authentication information concerning a collector; transmitting the test service requirements to the collector electronic terminal; receiving encrypted test data concerning a location of the collector electronic terminal, an identification of a test subject, and test sample data; analysing at the server the test data to determine that the test has been properly completed; and transmitting a signal from the server to the collector electronic terminal, which signal indicates that the test has been properly completed and also locks access to test data saved on the collector electronic terminal.

Description

TITLE

SYSTEM AND METHOD FOR TEST MANAGEMENT AND REPORTING

FIELD OF THE INVENTION

The present invention relates to test management. In particular, although not exclusively, the invention relates to online systems for drug and alcohol test management and reporting.

BACKGROUND TO THE INVENTION

The collection and transmission of private, confidential or otherwise sensitive information generally presents risks that the security and privacy of the information may be breached. In many situations, such as with drug and alcohol testing, the recording of private and sensitive personal information can raise significant risks concerning the privacy of individuals, and concerning the reputation and legal liability of employers and organisations assigned to collecting and managing such information. Thus the interception or unauthorised public release of such information can have severe consequences for the person providing the. information (the donor), the person collecting the information (the collector), the organisation that the hires the collector (the collection agency), and for the organisation requesting the collection (the requesting authority).

Conventional drug and alcohol test management and reporting systems generally depend on the expertise and reliability of numerous individuals, including third parties such as postal workers, to ensure the accuracy and security of collected data. Test samples and results may be transmitted between numerous locations, which can raise numerous potential points of failure where lapses in accuracy and security can occur. For example, it often can be difficult to establish a reliable and clear "chain of custody" of a sample between the point of collection and the final document storage system/ location and for information relating to an individual donor for a sample that is despatched to a confirmation testing location. Further, thorough training of test collectors engaged by collection agencies can be expensive, and significant on-the-job experience can be required to ensure that proper protocols for all required tests are consistently and reliably followed. Even extremely skilled and experienced trained collectors can still make errors and omit important information, especially when working within time constraints and other pressures typically encountered in performing these duties. Required test collection and processing procedures can often vary widely across tests, regions (state/ international areas), between organisations, and different matrices (for example urine or saliva drug testing) such that breakdowns in such procedures can generate erroneous results, workplace unrest/ legal action or require expensive re-testing.

In certain circumstances donors may have taken various medications prior to participating in a test and those medications may impact upon the test results returned from samples that they subsequently provide. Such medications are typically declared during the testing process and this tends to be key information that is typically relied upon by Medical Review Officers (MRO) to compare with screening test results and to evaluate the potential that the person might remain at work. The historical role of the MRO has typically been in reviewing test results from final analysis in the laboratory, however with an increased prevalence of on-site screening, this role is now also focused upon screen test results and declared medications. However MRO review can be time consuming and relies upon the availability of the MRO at the precise time of the test to perform often rudimentary determinations regarding a donor's work ready (or other) status.

Therefore there is a need for an improved system and method for test management and reporting. OBJECT OF THE INVENTION

It is an object of some embodiments of the present invention to provide consumers with improvements and advantages over the above described prior art, and/or overcome and alleviate one or more of the above described disadvantages of the prior art, and/or provide a useful commercial choice. SUMMARY OF THE INVENTION

According to one aspect, the invention resides in a computer implemented method of managing a test, including:

pre-recording test service requirements at a computer server;

transmitting a notification of a proposed test from the server to a collector electronic terminal- receiving at the server, from the collector electronic terminal, authentication information concerning a collector;

transmitting the test service requirements from the server to the collector electronic terminal;

receiving at the server, from the collector electronic terminal, encrypted test data concerning a location of the collector electronic terminal, an identification of a test subject, and test sample data;

analysing at the server the test data to determine that the test has been properly completed; and

transmitting a signal from the server to the collector electronic terminal, which signal indicates that the test has been properly completed and that locks access to test data saved on the collector electronic terminal.

Preferably, the server further processes chain of custody data concerning the test data.

Preferably, when operating in a networked environment the server transmits signals to the collector electronic terminal that activate in real time specific test procedures required for the test subject; or

Preferably, when operating in a non-networked environment the collector electronic terminal activates in real time specific test procedures for the test subject. Preferably, the test service requirements are selected from one or more of the following: client name and location, a test matrix, identification of a test kit, test site safety instructions, day and time variables (such as proposed arrival, required stay & departure day/times), information concerning on-site communications, identification of test equipment, and test protocols.

Preferably, the authentication information concerning the collector is obtained using one of the following: entry of a pass code transmitted to an alternative device of the collector, scanning an identification badge, entry of a pass code of a token synchronised with the computer server, and entry of a password.

Preferably, using the collector electronic terminal, the server prompts the collector to accept or reject the proposed site visit (job).

Preferably, using the collector electronic terminal, the server prompts the collector to contact relevant contact persons concerning the proposed test.

Preferably, the server transmits job scheduling data, including travel instructions, to the collector electronic terminal, based on a plurality of proposed tests.

Preferably, position data of the collector electronic terminal is sent periodically from the collector electronic terminal to the server.

Preferably, the server transmits a pre-test checklist to the collector electronic terminal.

Preferably, data from a pre-test interview is transmitted from the collector electronic terminal to the server before the test is conducted.

Preferably, the server analyses the data from the pre-test interview to determine whether any alerts should be transmitted to the collector electronic terminal.

Preferably, the data from the pre-test interview includes test subject medications and test subject health data.

Preferably, an electronic signature of the test subject is transmitted from the collector electronic terminal to the server. Preferably, identifications of test kit elements and equipment, scanned by the collector electronic terminal, are transmitted from the collector electronic terminal to the server.

Preferably, analysing the test data at the server includes transmitting requests for further test data from the server to the collector electronic terminal.

Preferably, analysing the test data includes recording image data received from the collector electronic terminal.

Preferably, the server transmits to the collector electronic terminal step by step instructions concerning packaging and sealing test samples.

Preferably, the step by step instructions concerning packaging and sealing test samples includes instructions concerning application of labels on test samples and test forms.

Preferably, the server receives signals from the collector electronic terminal indicating whether the test has been temporarily suspended.

Preferably, test data that is locked on the collector electronic terminal is accessible on the collector electronic terminal using a separate master encryption key.

Preferably, analysis of the test data includes conducting a data integrity check.

Alternatively, according to another aspect, the present invention resides in a computer implemented method of managing a test, including: pre-recording test service requirements at a collector electronic terminal;

processing a notification of a proposed test received at the collector electronic terminal;

processing, at the collector electronic terminal, encrypted test data concerning a location of the collector electronic terminal, an identification of a test subject, and test sample data;

analysing at the collector electronic terminal the test data to determine that the test has been properly completed; and processing at the collector electronic terminal a signal that indicates the test has been properly completed and that locks access to test data saved on the collector electronic terminal. BRIEF DESCRIPTION OF THE DRAWINGS

To assist in understanding the invention and to enable a person skilled in the art to put the invention into practical effect, preferred embodiments of the invention are described below by way of example only with reference to the accompanying drawings, in which:

FIG. 1 illustrates an example of a display of a collector electronic terminal, including a proposed job notice, according to an embodiment of the present invention;

FIG. 2 illustrates a subsequent display on the display screen of FIG. 1 , where a collector logs into a server;

FIG. 3 illustrates a subsequent display on the display screen of

FIG. 1 , where the collector electronic terminal establishes a communication link to a computer server of a collection agency;

FIG. 4 illustrates a subsequent display on the display screen of FlG. 1 , where the collector electronic terminal records confirmation of acceptance or notification of rejection of a proposed test for sending to the server;

FIG. 5 illustrates a subsequent display on the display screen of FIG. 1 , where the collector is reminded to contact a nominated client representative (NCR) at an appointed time prior to visiting a site;

FIG. 6 illustrates a subsequent display on the display screen of

FIG. 1 , where a test management console is displayed to a collector;

FIG. 7 illustrates a subsequent display on the display screen of FIG. 1 , including a testing menu;

FIG. 8 illustrates a subsequent display on the display screen of FIG. 1 , including a testing console;

FIG. 9 illustrates a subsequent display on the display screen of FIG. 1 , where a travel management console is displayed to a collector. FIG. 10 illustrates a subsequent display on the display screen of FIG. 1 , including a job travel menu;

FIG. 11 illustrates a subsequent display on the display screen of FIG. 1 , which display is presented to a collector after a particular job has been selected from the job travel menu shown in FIG. 10;

FIGs. 12, 13 and 14 illustrate subsequent displays on the display screen of FIG. 1 , concerning a test prestart checklist;

FIG. 15 illustrates a subsequent display on the display screen of FIG. 1 , where a collector is prompted to scan his or her identification card, or enter some biometric identification, such as a fingerprint, using the collector electronic terminal;

FIG. 16 illustrates a subsequent display on the display screen of FIG. 1 , where donor details of a particular test subject are entered into the collector electronic terminal;

FIG. 17 illustrates a subsequent display on the display screen of

FIG. 1 , including identification of an identification means;

FIG. 18 illustrates a subsequent display on the display screen of FIG. 1 , where medications declared by a donor are recorded in a table format;

FIG. 19 illustrates a subsequent display on the display screen of

FIG. 1 , where the collector obtains consent for a test from a test subject;

FIGs. 20 and 21 illustrate subsequent displays on the display screen of FIG. 1 , showing active and passive test modes, respectively, of the collector electronic terminal;

FIGs. 22 and 23 illustrate subsequent displays on the display screen of FIG. 1 , showing test integrity checking modes regarding, respectively, urine and saliva tests;

FIGs. 24 and 25 illustrate subsequent displays on the display screen of FIG. 1 , showing execution of drug screening processes using, respectively, urine and saliva; FIGs. 26 and 27 illustrate subsequent displays on the display screen of FIG. 1 , which displays guide the collector through a laboratory packaging process;

FIG. 28 illustrates a subsequent display on the display screen of FIG. 1 , enabling results to be provided to a third party; and

FIG. 29 illustrates a computer server, with which the methods of test management and reporting of the present invention may be implemented.

Those skilled in the art will appreciate that minor deviations from the layout of components as illustrated in the drawings will not detract from the proper functioning of the disclosed embodiments of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Embodiments of the present invention comprise test management and reporting systems and methods. Elements of the invention are illustrated in concise outline form in the drawings, showing only those specific details that are necessary to the understanding of the embodiments of the present invention, but so as not to clutter the disclosure with excessive detail that will be obvious to those of ordinary skill in the art in light of the present description.

In this patent specification, adjectives such as first and second, left and right, front and back, top and bottom, etc., are used solely to define one element or method step from another element or method step without necessarily requiring a specific relative position or sequence that is described by the adjectives. Words such as "comprises" or "includes" are not used to define an exclusive set of elements or method steps. Rather, such words merely define a minimum set of elements or method steps included in a particular embodiment of the present invention.

According to one aspect, the invention resides in a computer implemented method of managing a test, including: pre-recording test service requirements at a computer server; transmitting a notification of a proposed test from the server to a collector electronic terminal; receiving at the server, from the collector electronic terminal, authentication information concerning a collector; transmitting the test service requirements from the server to the collector electronic terminal; receiving at the server, from the collector electronic terminal, encrypted test data concerning a location of the collector electronic terminal, an identification of a test subject, and test sample data; decrypting and analysing at the server the test data to determine that the test has been properly completed; and transmitting a signal from the server to the collector electronic terminal, which signal indicates that the test has been properly completed and that locks access to test data saved on the collector electronic terminal.

Advantages of some embodiments of the present invention include enabling secure, automated test execution and secure, automated processing of test results. This ensures that only the correct tests are properly conducted at the right time on the correct test subjects, that a clear chain of custody of resulting test samples and test data is achieved and fully documented, and that efficiency is improved in the scheduling, conducting, analysis and reporting of tests. These advantages can be achieved through the improved system and method for test management and reporting as described herein.

Throughout this document the terms job and test are generally used interchangeably.

FIG. 1 illustrates an example of a display screen 100 of a collector electronic terminal, including a proposed job notice, according to an embodiment of the present invention. For example, consider that the collector electronic terminal is a smart phone used by a collector employed by a drug and alcohol test collection agency. When a computer server of the agency receives a request for one or more drug and alcohol tests from a requesting authority, such as a third party company, or when instigated by a staff member working for the collection agency, the server transmits a notification of a proposed test, in the form of a site visit, to the collector electronic terminal. As shown, the display screen 100 of the smart phone then displays a message such as "You have a job request. Please login to accept/reject." As will be understood by those skilled in the art, the collector electronic terminal alternatively can be another type of electronic device, such as a notebook computer, personal computer or dedicated handheld device.

FIG. 2 illustrates a subsequent display on the display screen 100, where the collector logs into the server. For example, the collector electronic terminal may prompt the collector to scan their ID card and enter a 2-factor authentication key (e.g., from a token, SMS or other unique password). Alternatively, to address the potential for damaged barcodes, an identification can be entered using a keypad (not shown) on the collector electronic terminal. An enhanced security option is that the collector electronic terminal can be allocated to only one collector (so that it will only allow input , and scans from one collector). In multi-user environments, where multiple collectors may use the same collector electronic terminal, this feature can be either disabled or be restricted to operate only with specific collector ID's.

FIG. 3 illustrates a subsequent display on the display screen 100, where the collector electronic terminal establishes a communication link to the computer server of the collection agency. In cases where tokens are synchronized with the database server, an additional level of security can be achieved. After the communication link is established and the collector is successfully authenticated with the server, basic details for a site visit, such as location, client name, expected duration, and number of tests required are transmitted to the collector electronic terminal.

FIG. 4 illustrates a subsequent display on the display screen 100, where the server receives confirmation of acceptance or notification of rejection of the proposed test visit. For example, as shown, the collector is provided details of a job, such as a four hour site visit to XYZ Company, and is prompted to accept, reject, or view a diary concerning other jobs. If the job is rejected, an administrator of the collection agency is notified in order to reschedule the job or to allocate the job to another collector. A collector can be informed of any changes to a scheduled site visit using a process similar to the above, but identified as a "job amendment."

Further details of a job, such as safety requirements, prior notification requirements for specific people, and names and dates of birth of donors previously tested at a particular location can be used to assist in pre-populating fields for data entry and to reduce errors. In the event that the client has bar coded ID cards, these can also be transmitted to the collector electronic terminal to expedite testing at a scheduled time. All data transferred is encrypted for de-encryption on the collector electronic terminal, and full file transfer is verified and confirmed by the collector electronic terminal. Various standard encryption and decryption techniques can be used, as understood by those having ordinary skill in the art.

FIG. 5 illustrates a subsequent display on the display screen 100, where the collector is reminded to contact a nominated client representative (NCR) at an appointed time prior to visiting a site. On the collector electronic terminal, the collector logs in following the process described above concerning FIG. 2, and the details of the confirmed job are then displayed on the collector electronic terminal. Confirmation that the NCR has been contacted is then conveyed to the server of the collection agency. An exception query on the server may alert a collection agency administrator of any occasions where the NCR has not been contacted by the collector by the appointed time.

FIG. 6 illustrates a subsequent display on the display screen 100, where a test management console is displayed to a collector. Graphical icons 600 adapted for a particular test circumstance are shown on the screen 100. The test management console enables the collector to navigate to different aspects of the test management software. For example, as shown, the console may include sub-menus for travel, calendaring, testing, incident reporting, secure transmissions, and setup options. FIG. 7 illustrates a subsequent display on the display screen 100, including a testing menu. Given the testing sub-items are associated with a given job, the collector first selects a job (e.g., from either a list format or a calendar format). After selecting a given job, the collector is then presented with various options relevant to that job.

FIG. 8 illustrates a subsequent display on the display screen 100, including a testing console. The testing console is used to present to a collector the various options relevant to a particular job. For example, as shown, the testing console may include options for reviewing, displaying, or editing parameters such as pre-start checks, client details, new tests, incident reporting, incomplete tests, and completed tests.

FIG. 9 illustrates a subsequent display on the display screen 100, where a travel management console is displayed to a collector. This console enables the collector to manage, from a single screen, their daily travels between job sites. For example, as shown, the travel management console can include options for navigating to other features of the software, such as: travel for job, view calendar, other travel, incident reporting, transmit travel to server, and a travel log.

FIG. 10 illustrates a subsequent display on the display screen 100, including a job travel menu. Similar to the testing menu described above, a job can first be selected from either a job list or a calendar.

FIG. illustrates a subsequent display on the display screen 100, which display is presented to a collector after a particular job has been selected from the job travel menu shown in FIG. 10. For example, a collector can select from the following options concerning travel for a particular job: pre-start checks, client details, travel log, incident reporting, incomplete travel, and completed travel.

Those skilled in the art of the present invention will recognize that other alternative screens may also be presented to a collector, according to alternative embodiments of the present invention. For example, departure and arrival screens can be used to document a collector's departure to and arrival at a job site. Before a particular test, and after logging into the collector electronic terminal, a collector can be prompted to confirm departure to a site, and can be prompted to record the odometer reading on their vehicle. Alternatively, GPS or other positioning software can be used to calculate a distance between the collector's current location and the next job site. The departure details are then transmitted to the collection agency's server to monitor the safe travel of the collector and for payment/billing purposes.

The collector electronic terminal can further prompt entry of odometer readings upon arrival at a job site. An exception query then can be used to prompt a user in cases where arrival notification from a collector is not received at the collection agency's server.

Prior to commencement of testing, prestart checklists can be displayed to the collector and managed by the collector electronic terminal. For example, use of such checklists can ensure that: a testing environment is safe, a testing room is private and secure, there are no environmental contaminants that might affect testing, and that all test equipment is operating properly. In the event of any equipment problems, troubleshooting procedures can be automatically downloaded from the server and executed by the collector electronic terminal. Before and during testing the collector electronic terminal may be connected to testing equipment through a wired or wireless connection, enabling automated interaction between the collector electronic terminal and the testing equipment.

FIGs. 12, 13 and 14 illustrates subsequent displays on the display screen 100, concerning a test prestart checklist. FIG. 12 queries whether there are any hazards present in the testing room. FIG. 13 queries whether an automated check of all connected devices should be initiated by the collector electronic terminal. FIG. 14 queries the collector to enter a risk score on a sliding scale concerning a particular identified hazard risk. An estimate of the severity of a likely result if the hazard were to occur is also entered by the collector using a sliding scale. FIG. 15 illustrates a subsequent display on the display screen 100, where a collector is prompted to scan his or her identification card, or enter some biometric identification, such as a fingerprint, using the collector electronic terminal.

FIG. 16 illustrates a subsequent display on the display screen 100, where donor details of a particular test subject are entered into the collector electronic terminal. For test subjects with previously recorded details, the details can be automatically populated by, for example, scanning an identification of the test subject.

FIG. 17 illustrates a subsequent display on the display screen 100, including identification of an identification means. For example, the display can indicate that a donor's staff ID card was sighted by the collector.

FIG. 18 illustrates a subsequent display on the display screen 100, where medications declared by a donor are recorded in a table format. Potential consequences of such medications then can be later automatically analysed by the collector electronic terminal. For example, the collector electronic terminal can access a list of known compounds that can cross-react with a specific test kit. An alert can then be provided to the collector and the results of rule based analysis can be applied to negate the need for MRO evaluation to determine if the donor is to remain at work. The collector can automatically terminate the test at any time, for example if it is unsafe to continue wjth the test, in the event of an emergency or if the donor elects to discontinue with the test.

FIG. 19 illustrates a subsequent display on the display screen 100, where the collector obtains consent for a test from a test subject. For example, the test subject can sign their name using an electronic stylus or other form of electronic or biometric signature. The collector electronic terminal can automatically ensure that a test cannot proceed unless explicit consent from the test subject has been obtained.

FIGs. 20 and 21 illustrate subsequent displays on the display

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screen 100, showing active and passive test modes, respectively, of the collector electronic terminal. For example, alcohol testing is typically conducted using an electronic breath alcohol testing device. This may include an initial passive mode alcohol test followed by an active mode test (or further active mode tests) or the requesting authority may require that all staff are tested in active mode. Regardless, the collector electronic terminal can guide the collector throughout the process, including repeated tests in cases where kits fail to operate as required. If the requesting authority does not require further testing apart from alcohol testing, the collector electronic terminal software can guide the collector to a reporting section. Data from the breathalyzer equipment can be uploaded to the collector electronic terminal manually or using a wired or wireless connection.

FIGs. 22 and 23 illustrate subsequent displays on the display screen 100, showing the identification of the test kit used and test integrity checking modes regarding, respectively, urine and/qr saliva tests. An important feature of performing drug screen testing is that the test kit used to perform the test is appropriately recorded. This can be achieved for example through scanning a barcode appearing on the satchel containing the test kit or built onto the test kit itself. Another important part of performing drug screening is ensuring the integrity of samples collected. While this tends to be less of an issue with saliva drug testing, there are still precautions that can be followed to reduce the impact of any tampering and the collector electronic terminal guides the Collector through those precautions. Modern urine screening kits tend to be fully integrated with integrity tests, for example, OXI = oxidants; CRE = creatinine; pH = acidity; XXX/y/z = alternative customizable options.

In situations where a sample fails an initial verification, the collector electronic terminal automatically requests a further sample, and also executes a process for dispatching the original sample that failed the integrity testing.

FIGs. 24 and 25 illustrate subsequent displays on the display screen 100, showing execution of drug screening processes using, respectively, urine and saliva. Drug test screening is typically conducted using a non-instrumented device which relies upon visual interpretation of a test panel by a collector. However, various electronic devices exist that electronically interpret results and display results and/or have printing functionality. In this regard, it is possible that drug testing results will be entered manually by the collector, or read and interpreted by a scanner or electronic reader device connected to the collector electronic terminal. As with other testing modes, the collector can also record notes relevant to a test.

In the event that all samples are negative, the collector electronic terminal will automatically guide the collector to complete the testing process, with printing options for donor or supervisor copies. Otherwise, the collector electronic terminal guides the collector through the lab packaging process.

According to still other embodiments of the present invention, the collector electronic terminal software can be integrated with existing peripheral scanners designed to interpret the results of a specific test and to automatically populate the test results against each of the drug classes for which a test was conducted. That can improve accuracy and remove collector interpretation issues.

FIGs. 26 and 27 illustrate subsequent displays on the display screen 100, which displays guide the collector through a laboratory packaging process. Encoded seal identification numbers used on sample bottles or vials, such as with bar codes, can reduce human error in recording identification information. Such encoded seal identification numbers can be read automatically by a scanner or camera incorporated into the collector electronic terminal. Further, requiring an electronic signature of a witness when the seal identification numbers are recorded also increases accuracy and security, and strengthens the chain of custody regarding the samples.

After a test is completed a signal is transrnitted from the server to the collector electronic terminal, which signal indicates that the test has been properly completed and that locks access to test data saved on the collector electronic terminal. That also further ensures data integrity, security and privacy.

FIG. 28 illustrates a subsequent display on the display screen 100, enabling results to be provided to a third party. For example, where provided for in client booking instructions originally sent to the collector electronic terminal, the collector is prompted to obtain an NCR acknowledgment, including a result notification.

In addition to the functionality described in detail in the figures, various other functions of the collector electronic terminal are also enabled by the present disclosure. For example, incident reporting can be managed through the collector electronic terminal, with a broadcast escalation feature that transmits alerts to various parties depending on the nature or severity of an incident. For example, an incident concerning damaged equipment can automatically transmit a report to a maintenance organization; but an incident concerning an acute health risk to a donor can automatically generate an emergency call to obtain urgent medical assistance or where the Collector might be under duress an emergency call can instigate prompt assistance.

FIG. 29 illustrates an example of a computer server 2900, with which the methods of test management and reporting of the present invention may be implemented. For example, the server 2900 may be operated by a drug and alcohol test collection agency that has equipped several individuals employed as collectors with collector electronic terminals.

The computer server 2900 includes a central processor 2902, a system memory 2904 and a system bus 2906 that couples various system components including coupling the system memory 2904 to the central processor 2902. The system bus 2906 may be any of several types of bus structures including a memory bus or memory controller, a peripheral bus, and a local bus using any of a variety of bus architectures. The structure of system memory 2904 is well known to those skilled in the art and may include a basic input/output system (BIOS) stored in a read only memory (ROM) and one or more program modules such as operating systems, application programs and program data stored in random access memory (RAM).

The computer server 2900 may also include a variety of interface units and drives for reading and writing data. In particular, the computer server 2900 includes a hard disk interface 2908 and a removable memory interface 2910 respectively coupling a hard disk drive 2912 and a removable memory drive 2914 to system bus 2906. Examples of removable memory drives 2914 include magnetic disk drives and optical disk drives. The drives and their associated computer-readable media, such as a Digital Versatile Disc (DVD) 2916 provide nonvolatile storage of computer readable instructions, data structures, program modules and other data for the computer server 2900. A single hard disk drive 2912 and a single removable memory drive 2914 are shown for illustration purposes only and with the understanding that the computer server 2900 may include several similar drives. Furthermore, the computer server 2900 may include drives for interfacing with other types of computer readable media.

The computer server 2900 may include additional interfaces for connecting devices to system bus 2906. FIG. 29 shows a universal serial bus (USB) interface 2918 which may be used to couple a device to the system bus 2906. An IEEE 1394 interface 2920 may be used to couple additional devices to the computer server 2900.

The computer server 2900 can operate in a networked environment using logical connections to one or more remote computers or other devices, such as a server, a router, a network personal computer, a peer device or other common network node, a wireless telephone or wireless personal digital assistant. In particular, the computer server 2900 interfaces with the collector electronic terminal described herein. The computer 2900 includes a network interface 2922 that couples system bus 2906 to a local area network (LAN) 2924. Networking environments are commonplace in offices, enterprise-wide computer networks and home computer systems.

A wide area network (WAN), such as the Internet, can also be accessed by the computer server 2900, for example via a modem unit connected to serial port interface 2926 or via the LAN 2924.

It will be appreciated that the network connections shown and described are exemplary and other ways of establishing a communications link between the computers can be used. The existence of any Of various well-known protocols, such as TCP/IP, Frame Relay, Ethernet, FTP, HTTP and the like, is presumed, and the computer server 2900 can be operated in a client-server configuration to permit a user to retrieve web pages from a web-based server. Furthermore, any of various conventional web browsers can be used to display and manipulate data on web pages.

Method steps of the present invention are advantageously received over a network interface as described above. The user interfaces may reside on a web server, and be accessed via a web interface. Alternatively, the user interfaces may reside on a dedicated application, which sends information to a server via a suitable protocol.

The operation of the computer server 2900 can be controlled by a variety of different program modules. Examples of program modules are routines, programs, objects, components, and data structures that perform particular tasks or implement particular abstract data types. The present invention may also be practiced with other computer server configurations, including hand-held devices, multiprocessor systems, microprocessor- based or programmable consumer electronics, network PCS, minicomputers, mainframe computers, personal digital assistants and the like. Furthermore, the invention may also be practiced in distributed computing environments where tasks are performed by remote processing devices that are linked through a communications network. In a distributed computing environment, program modules may be located in both local and remote memory storage devices. Program modules for generating particular displays and functions of a collector electronic terminal are advantageously present in the computer server 2900. Additionally, program modules for processing method steps of the present invention, such as transmitting test service requirements to a collector electronic terminal, are advantageously present in the computer server 2900.

Alternatively, those skilled in the art will appreciate that software for operating the collector electronic terminal can reside entirely or primarily in an electronic memory of the collector electronic terminal. Thus most or all of the above described features and advantages of the present invention can be achieved with a collector electronic terminal that operates generally autonomously of a collection organisation's server. Such a collector electronic terminal can then be synchronized with a server only intermittently. Such embodiments can be particularly useful where, for example, testing is conducted in remote rural areas where wired or wireless connectivity to the Internet may be restricted.

In summary, advantages of some embodiments of the present invention include enabling secure, automated test execution and secure, automated processing of test results. That can ensure that only the correct tests are properly conducted at the right time on the correct test subjects, that a clear chain of custody of resulting test samples and test data is achieved and fully documented, and that efficiency is improved in the scheduling, conducting, analysis and reporting of tests. .

The above description of various embodiments of the present invention is provided for purposes of description to one of ordinary skill in the related art. It is not intended to be exhaustive or to limit the invention to a single disclosed embodiment. As mentioned above, numerous alternatives and variations to the present invention will be apparent to those skilled in the art of the above teaching. Accordingly, while some alternative embodiments have been discussed specifically, other embodiments will be apparent or relatively easily developed by those of ordinary skill in the art. Accordingly, this patent specification is intended to embrace all alternatives, modifications and variations of the present invention that have been discussed herein, and other embodiments that fall within the spirit and scope of the above described invention.

Claims

1. A computer implemented method of managing a test, including: pre-recording test service requirements at a computer server;

transmitting a notification of a proposed test from the server to a collector electronic terminal;

receiving at the server, from the collector electronic terminal, authentication information concerning a collector;

transmitting a signal from the server to the collector electronic terminal, which signal indicates that the test has been properly completed and locks access to test data saved on the collector electronic terminal.

2. The method of claim 1 , wherein the server further processes chain of custody data concerning the test data.

3. The method of claim 1 , wherein, when operating in a networked environment, the server transmits signals to the collector electronic terminal that activate in real time specific test procedures required for the test subject.

4. The method of claim 1 , wherein, when operating in a networked environment, the collector electronic terminal activates in real time specific test procedures for the test subject.

5. The method of claim 1 , wherein the test service requirements are selected from one or more of the following: client name and location, a test matrix, identification of a test kit, test site safety instructions, day and time variables (such as proposed arrival, required stay & departure day/times), information concerning on-site communications, identification of test equipment, and test protocols.

6. The method of claim 1 , wherein the authentication information concerning the collector is obtained using one of the following: entry of a pass code transmitted to an alternative device of the collector, scanning ^•an identification badge, entry of a pass code of a token synchronised with the computer server, and entry of a password.

7. The method of claim 1 , wherein the server, using the collector electronic terminal, prompts the collector to accept or reject the proposed site visit Gob).

8. The method of claim 1 , wherein the server, using the collector electronic terminal, prompts the collector to contact relevant contact persons concerning the proposed test.

9. The method of claim 1 , wherein the server transmits job scheduling data, including travel instructions, to the collector electronic terminal, based on a plurality of proposed tests.

10. The method of claim 1 , wherein position data of the collector electronic terminal is sent periodically from the collector electronic terminal to the server.

11. The method of claim 1 , wherein the server transmits a pre-test checklist to the collector electronic terminal.

12. The method of claim 1 , wherein data from a pre-test interview is transmitted from the collector electronic terminal to the server before the test is conducted.

13. The method of claim 12, wherein the server analyses the data from the pre-test interview to determine whether any alerts should be transmitted to the collector electronic terminal.

14. The method of claim 12, wherein the data from the pre-test interview includes test subject medications and test subject health data.

15. The method of claim 1 , wherein an electronic signature of the test subject is transmitted from the collector electronic terminal to the server.

16. The method of claim 1 , wherein identifications of test kit elements and equipment, scanned by the collector electronic terminal, are transmitted from the collector electronic terminal to the server.

17. The method of claim 1 , wherein analysing the test data at the server includes transmitting requests for further test data from the server to the collector electronic terminal.

18. The method of claim 1 , wherein analysing the test data includes recording image data received from the collector electronic terminal.

19. The method of claim 1 , wherein the server transmits to the collector electronic terminal step by step instructions concerning packaging and sealing test samples.

20. The method of claim 19, wherein the step by step instructions concerning packaging and sealing test samples includes instructions concerning application of labels on test samples and test forms.

21. The method of claim 1 , wherein the server receives signals from the collector electronic terminal indicating whether the test has been temporarily suspended.

22. The method of claim 1 , wherein test data that is locked on the collector electronic terminal is accessible on the collector electronic terminal using a separate master encryption key.

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23. The method of claim 1 , wherein analysis of the test data includes conducting a data integrity check.

24. A computer implemented method of managing a test, including: pre-recording test service requirements at a collector electronic terminal;

analysing at the collector electronic terminal the test data to determine that the test has been properly completed; and

processing at the collector electronic terminal a signal that indicates the test has been properly completed and that locks access to test data saved on the collector electronic terminal.