Lis interchange manager

Abstract

Provided is a method and apparatus for communicating with Laboratory Information Systems (LIS). Specifically disclosed is a method and apparatus having unique message formatting for different laboratory areas. To accomplish this, the diagnostic instrument can form multiple connections with a single LIS. Each connection is customized with a set of configuration parameters, which can include a communication protocol, connection method, relevant information, and / or result formatting. Thus, disclosed is a diagnostic instrument that can communicate results to multiple different LIS Environments. Thus, disclosed is a diagnostic instrument comprising a LIS Interchange Manager (LIM).

Description

[0001] LIS INTERCHANGE MANAGER

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims the benefit of U.S. Provisional Application No. 63 / 517,698, filed August 4, 2023, entitled “LIS Interchange Manager,” the entire contents of each of which are incorporated by reference herein.

[0004] FIELD OF THE INVENTION

[0005] The present invention pertains in general to diagnostic instruments and in particular to diagnostic instruments connected to a Laboratory Information Systems (LIS).

[0006] BACKGROUND OF THE INVENTION

[0007] Recent studies have shown that patients with severe sepsis or septic shock showed an increased likelihood of death of 7.6% for every hour in which antibiotic therapy is not applied, such as shown in Liang et al., Empiric Antimicrobial Therapy in Severe Sepsis and Septic Shock: Optimizing Pathogen Clearance, Curr Infect Dis Rep. 2015 July; 17(7): 493. Sample-to-answer systems greatly increase the speed by which doctors can obtain patient results and begin treatment. Current diagnostic instruments allow for a single connection to Laboratory Information Systems (LIS). This means that each instrument has a single connection with the LIS, where a connection is defined by the information required to communicate with the LIS including communication protocol (ASTM or HL7), connection method (TCP / IP or Serial), relevant information and result formatting. Once a connection is configured, all results are sent in the specified formatting. This presents challenges where a diagnostic instrument communicates results for multiple areas of the laboratory (General Laboratory, Microbiology, Core Lab, Point of Care, etc), but each area has unique message formatting requirements. Indeed, LIS systems are notorious for being inflexible and hard to adapt to new requirements. Delay is caused when messages are not received in the proper format by the LIS, which can ultimately impact patient care and survival rates.

[0008] SUMMARY OF THE INVENTION

[0009] Provided herein are methods and apparatuses for a diagnostic instrument capable of forming multiple connections with a Laboratory Information Systems (LIS). Further provided are methods and apparatuses for communicating detection results in multiple different formats to a single LIS or to multiple LISs. Herein, the first step in communicating detection results is to define a procedure for reporting because even labs within the same hospital network have their own unique reporting requirements. For example, each laboratory can have a different communication protocol (ASTM or HL7), connection method (TCP / IP or Serial), relevant information, and result formatting. Keeping track of which results get reported where and with what information is complicated, especially when multiple assay panels are run on a single instrument and each panel is reported to different laboratories and thus need different formatting. Additionally, within the same laboratory, each panel may be reported differently dependent on the use case i.e. respiratory infection panel results will, e.g., be reported via molecular formatting, while Blood Culture Identification (BCID) panel results will, e.g., be reported via microbiology formatting.

[0010] A result reporting framework should contain more than just an articulation that a result needs to be reported, this is especially true when a centralized diagnostic instrument is reporting results to different laboratories. Historically, diagnostic instruments reported results within a single lab utilizing the same message structure for all results that are sent from that instrument. Laboratories could not, on a single instrument, elect different result formats for different reported tests. In some instances, diagnostic instruments reported results to a single lab and therefore there was no need to configure results so that different assay panels are reported differently to different laboratories. Hospitals / diagnostic instrument providers must develop an overall result reporting strategy that accounts for this and provides a comprehensive plan to ensure that results can be received by different laboratory LIS environments, with the correct information and in a format that is useable by each laboratory.

[0011] In order to accommodating for these needs and supporting the high degree of complexity when reporting diagnostic results methods, apparatuses and systems are provided herein for reporting results. Generally, such diagnostic instruments are configured with unique multiple connections to the LIS. Only results with a defined format are conveyed over each unique connection to the LIS. Further, diagnostic instruments are provided comprising a LIS Interchange Manager (LIM).

[0012] BRIEF DESCRIPTION OF THE DRAWINGS

[0013] FIG. l is a schematic diagram of an example of a system architecture disclosed herein.

[0014] FIG. 2 illustrates a flow chart of example operations that an apparatus will perform when receiving data (results), configuring the results and sending the configured results to two different LIS Environments on a single LIS Host.

[0015] FIG. 3 is a schematic diagram of an example of a system architecture for receiving data (result), configuring the result and sending the configured result to a LIS Environment.

[0016] FIG. 4 is another schematic diagram of an example of a system architecture for receiving data (result), configuring the result and sending the configured result to a LIS Environment.

[0017] FIG. 5 is a flowchart representation of an exemplary process performed by an example of the system. FIG. 6 is a flow chart of an example of an exemplary software architecture for a system.

[0018] FIG. 7 illustrates a flow chart of an example operations that an apparatus will perform when receiving data (result), configuring the result and sending the configured result to two LIS Environment(s).

[0019] FIG. 8 is a schematic diagram of an example of an exemplary software architecture for a system. Fig. 9 is a block diagram representing an exemplary software architecture for the system.

[0020] DETAILED DESCRIPTION OF THE INVENTION

[0021] Provided herein is a method and apparatus for having more than one communication protocol (e.g., ASTM or HL7) with a Laboratory Information System (LIS). Further provided is a method and apparatus for having more than one connection method (e.g., TCP / IP or Serial) with the Laboratory Information System (LIS). Such a method and apparatus may be configured for sending specified relevant information to the LIS. Further provided is a method and apparatus for sending results in more than one format to the Laboratory Information System (LIS).

[0022] Also provided is a method and apparatus for having more than one communication protocol (e.g., ASTM or HL7) and more than one connection method (e.g., TCP / IP or Serial) with the Laboratory Information System (LIS). Further provided is a method and apparatus for having more than one communication protocol (e.g., ASTM or HL7) and sending specified relevant information to the Laboratory Information System (LIS). Further provided is a method and apparatus for having more than one communication protocol (e.g., ASTM or HL7) and sending results in more than one format to the Laboratory Information System (LIS).

[0023] Also provided is a method and apparatus for having more than one connection method (e.g., TCP / IP or Serial) and sending specified relevant information to the Laboratory Information System (LIS). Further provided is a method and apparatus for having more than one connection method (e.g., TCP / IP or Serial) and sending results in more than one format to the Laboratory Information System (LIS).

[0024] Also provided is a method and apparatus for sending relevant information and sending results in more than one format to the Laboratory Information Systems (LIS).

[0025] Also provided is a method and apparatus for having more than one communication protocol (e.g., ASTM or HL7), more than one connection method (e.g., TCP / IP or Serial) and sending specified relevant information to the Laboratory Information System (LIS). Further provided is a method and apparatus for having more than one communication protocol (e.g., ASTM or HL7) more than one connection method (e.g., TCP / IP or Serial) and sending results in more than one format to the Laboratory Information System (LIS). Also provided is a method and apparatus for having more than one connection method (e.g., TCP / IP or Serial), sending relevant information and sending results in more than one format to the Laboratory Information System (LIS).

[0026] Also provided is a method and apparatus for having more than one communication protocol (e.g., ASTM or HL7) more than one connection method (e.g., TCP / IP or Serial), sending relevant information, and sending results in more than one format to the Laboratory Information System (LIS). Further provided is a method and apparatus for formatting data to be sent to a first LIS Environment and a second LIS Environment, the method comprising: generating a first data packet for the first LIS Environment, generating a second data packet for the second LIS Environment and delivering the first data packet to the first LIS Environment, and delivering the second data packet to the second LIS Environment. Herein, the first LIS Environment and second LIS Environment may be different. In some embodiments, the first LIS Environment and second LIS Environment may have different communication protocols, connection methods, relevant information, and / or result formatting and any combination thereof. In some embodiments, generating a first data packet comprises selecting a communication protocol, connection method, relevant information, and / or result formatting and any combination thereof. In some embodiments, generating a second data packet comprises selecting a communication protocol, connection method, relevant information, and / or result formatting and any combination thereof.

[0027] Further details applicable to any of these methods and apparatuses are provided below.

[0028] Definitions

[0029] As used in the claims and herein, the following terms have the following definitions:

[0030] “AAM” means “Assay Analysis Module”: An Assay Analysis Module contains the necessary information, including call logic, and target names to interpret raw data into a qualitative result. The AAM is contained inside the ADF and includes analysis parameters.

[0031] “ADF” means “Assay Definition File”. An ADF is a single compressed file containing component files for running a software assay protocol and analyzing generated data. Sometimes, Protocol and ADF are used interchangeably. The Assay Definition File is composed of an OPUS file and an AAM file.

[0032] “Assay panel” or “panel” means is a predetermined group of medical tests used in the diagnosis of infection or disease. For example, the cobas® eplex system (Roche Diagnostics) can run several different Blood Culture Identification (BCID) Panels (such as Gram Positive, Gram Negative, and Fungal) and a Respiratory Panel. Each panel has a plurality of targets.

[0033] It is noted that in this disclosure and particularly in the claims and / or paragraphs, terms such as “comprises”, “comprised”, “comprising” and the like can have the meaning attributed to it in U.S. Patent law; e.g., they can mean “includes”, “included”, “including”, and the like; and that terms such as “consisting essentially of’ and “consists essentially of’ have the meaning ascribed to them in U.S. Patent law, e.g., they allow for elements not explicitly recited, but exclude elements that are found in the prior art or that affect a basic or novel characteristic of the invention.

[0034] The term “client” can refer to an application, device, terminal or automatically or user-operable system that can access a remote service on a server via a network. The application, device, terminal or automatically or user-operable system may be provided by one or more computers.

[0035] “Data Forwarding Rule” or “DFR” means a rule which indicates where the data packet will be forwarded. The Data Forwarding Rule can be received from the Data Packet Identifier or be in the memory of the LIM and / or DFR Database. The Data Forwarding Rule can be based on the detection result, test order information, pending test order information, PTO information, cartridge information or combinations thereof.

[0036] A “data packet” is a unit of data (pay load) made into a single package. In some embodiments, a data packet from the pathogen detector includes, among other things, the detected target, nondetected targets or both.

[0037] The term “network” can refer to an operative interconnection of data processing devices including desktop, notebook, server or super-computers, personal digital assistants (PDAs), mobile phones, smart phones, digital cameras, or other digital devices or a combination thereof by means of one or more network connection media. Network connection media may include wired or wireless interconnections, wherein network connection media can include for example, electrical transmission lines, waveguides, fiber-optic media, laser communication systems, radio wave systems, and infrared systems. Two or more networks may be interconnected, hierarchically or otherwise organized and collectively referred to as one network. Furthermore, different networks can have different network topologies.

[0038] “LIS Environment” means a specific environment within an LIS. A LIS Environment may have specific requirements for connecting to the diagnostic instrument, receiving information or both.

[0039] “LIS Environment Information Packets” or “Configured Detection Result” means information which is delivered to a specific LIS Environment and can include a communication protocol (ASTM or HL7), connection method (TCP / IP or Serial), relevant information, formatted results and combinations thereof.

[0040] “Data Packet Identifier” or “Detection Result Identifier” means information in the data pack that indicates which LIS Environment to send the data pack to. The Data Packet Identifier comprises a detection result, test order information, pending test order information, PTO information, cartridge information or combinations thereof.

[0041] The term “server” refers to an application, device, terminal or automatically or user-operable system for providing one or more services to one or more clients. The services may be provided over one or more networks. A server may be configured to provide services in response to multiple concurrent requests via a network. The services may be provided by one or more computer programs.

[0042] As used herein, the term “about” refers to a + / — 10% variation from the nominal value. It is to be understood that such a variation is always included in a given value provided herein, whether or not it is specifically referred to.

[0043] The term “Cartridge” or “Consumable” means a cartridge that includes the necessary components to perform an assay. A Cartridge can be a Sample Cartridge, a QC Cartridge or a Cleaning Cartridge.

[0044] “Detection Result” means the result from processing a sample cartridge for a target. A Detection Result for a target can be “detected” or “not detected.”

[0045] “Detection Results” means the results from processing a sample cartridge for all of the targets on the cartridge.

[0046] “Diagnostic system” or “Diagnostic instrument” or “analysis device” or “Processing instrument” or “sample-to-answer system” is a manual, semi-automated or automated instrument that gathers information leading to the identification of a disease or disorder

[0047] GUI - A Graphical User Interface is a type of user interface that allows users to interact with electronic devices using images rather than text commands.

[0048] “ISW” means the instrument software.

[0049] “LIS” means laboratory information system (LIS), a computer software that processes, stores and manages data from all stages of medical processes and tests.

[0050] “Opus” means the portion of the ADF and includes control parameters.

[0051] “Patient cartridge” or “Sample Cartridge” or “PTO Cartridge” means a processing cartridge comprising a patient sample as opposed to a Quality Control Sample.

[0052] “Quality control assay” or “Quality control test” means an assay / test comprising external controls. “Cleaning Cartridge” means a cartridge that is used to clean the instrument.

[0053] “QC Cartridge” or “control cartridge” means a processing cartridge comprising a Quality Control Sample as opposed to a patient sample. The QC Cartridge is inserted into the testing process and treated as if they were a Sample Cartridge by being exposed to the same operating conditions. “QC result” means the result of the QC test.

[0054] “Quality control samples” means special specimens inserted into the testing process and treated as if they were patient samples by being exposed to the same operating conditions. The purpose of including quality control samples in analytical runs is to evaluate the reliability of a method by assaying a stable material that resembles patient samples.

[0055] “Quality control test” or “Quality control assay” means an assay used to assess Quality Control as opposed to a patient sample.

[0056] “RP2” means a respiratory panel.

[0057] “Sample” is used in its broadest sense. In one sense, it is meant to include a specimen or culture obtained from any source, as well as biological and environmental samples. Biological samples may be obtained from animals (including humans) and encompass fluids, solids, tissues, and gases. Biological samples include blood products, such as plasma, serum and the like. In contrast with some commercial systems that require some off chip handling of the sample, generally including sample extraction (cell lysis, for example), and sample preparation prior to detection. Thus, in accordance with aspects of the current system, a sample is loaded onto a BCID cartridge and the target analyte is extracted, amplified as necessary (for example, when the target analyte is a nucleic acid using polymerase chain reaction (PCR) techniques, although isothermal amplification methods can be utilized as well), and then detected using electrochemical detection, all on a microfluidic platform, generally referred to herein as a “multiplex cartridge” or a “fluid sample processing cartridge.” The BCID cartridge utilizes a sample preparation module as further described and shown in FIG. 15 of U.S. Pat. No. 9,598,722 (which is herein incorporated by reference in its entirety). In many embodiments, e.g. for the detection of human pathogens, the sample is a blood sample that is treated as outlined herein. Environmental samples include environmental material such as surface matter, soil, water, crystals and industrial samples. Such examples are not, however, to be construed as limiting the sample types applicable to the present technology.

[0058] “User selection” or “selecting” encompasses the diagnostic instrument receiving the user’s selection.

[0059] “Viewing” by a user encompasses displaying by the diagnostic instrument.

[0060] As used herein, the term “about” means encompassing plus or minus 10%. For example, about 90% refers to a range encompassing between 81% and 99% nucleotides. As used herein, the term “about” is synonymous with the term approximately.

[0061] Unless otherwise indicated or the context suggests otherwise, as used herein, “a” or “an” means “at least one” or “one or more.”

[0062] The word “or” as used herein means any one member of a particular list and also includes any combination of members of that list. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.

[0063] System

[0064] FIG. 1 is a schematic diagram of an example of a system 100. The example of the system 100 shown in FIG. 1 fundamentally includes an integrated diagnostic instrument 101 with multiple connections to a Laboratory Information System (LIS) 116 (shown as arrows in FIG. 1). In some embodiments, the diagnostic instrument 101 has two connections to a LIS. In some embodiments, the diagnostic instrument 101 has 2, 3, 4, or 5 connections to a LIS. In some embodiments, the diagnostic instrument 101 has 2-5 connections to a LIS. In some embodiments, the diagnostic instrument 101 has 2-10 connections to a LIS.

[0065] The diagnostic instrument 101 includes a pathogen detector 110, a LIS Interchange Manager (LIM) 111, and a LIS Interchange 115 (also referred to as, for example, a bi-directional LIS, or LIS communication system, or LIS interchange, or a bi-directional LIS communication system). Alternatively, the system may include any other suitable communication system such as a communication interface 112. The instrument 101 may be in communication with the end client 117 over the LIS Interchange 115 or communication interface 112. The LIS Interchange 115 or communication interface 112 may also include a local area network (LAN), a wired network, a wireless network, a wireless local area network (WLAN), a WI-FI® network (WI-FI is a registered trademark of Wireless Ethernet Compatibility Alliance, Inc. of Austin, Tex.), a personal area network (PAN), a wide area network (WAN), the Internet, an Internet Protocol (IP) network, and / or any other communications network, or any combination thereof. The diagnostic instrument 101 may also include a memory 109, a processor 113 and a database (and a space to store data / reports / alerts) 114. In some embodiments, the diagnostic instrument 101 may have a memory 109 in which the pathogen detector 110, the LIM 111, and the DFR database 105 are included. Examples of the processor 113 may include a general processor, a central processing unit, a microcontroller, a server, an application specific integrated circuit (ASIC), a digital signal processor, a field programmable gate array (FPGA), and / or a digital circuit, analog circuit. The processor 113 may be one or more devices operable to execute logic. The logic may include computer executable instructions or computer code embodied in the memory 109 or in other memory that when executed by the processor 113, cause the processor 113 to perform the features implemented by the logic. The computer code may include instructions executable with the processor 113. The memory 109 may be any device for storing and retrieving data or any combination thereof. The memory may include non-volatile and / or volatile memory, such as a random-access memory (RAM), a read-only memory (ROM), an erasable programmable readonly memory (EEPROM), or flash memory. Alternatively, or in addition, the memory may include an optical, magnetic (hard-drive) or any other form of data storage device. Each component may include additional, different, or fewer components.

[0066] The system 100 may be implemented in many different ways. Each module may be implemented as a circuit. Each circuit, such as the pathogen detector circuit 110, the LIS Interchange circuit 115, and the LIM circuit 111, may be hardware or a combination of hardware and software. For example, each circuit may include an application specific integrated circuit (ASIC), a Field Programmable Gate Array (FPGA), a digital logic circuit, an analog circuit, a combination of discrete circuits, gates, or any other type of hardware or combination thereof. Alternatively, or in addition, each circuit may include memory hardware, such as a portion of the memory 109, for example, that comprises instructions executable with the processor 113 or other processor to implement one or more of the features of the circuit. When any one of the circuits includes the portion of the memory that comprises instructions executable with the processor, the circuit may or may not include the processor. In some examples, each circuit may just be the portion of the memory 109 or other physical memory that comprises instructions executable with the processor 113 or other processor to implement the features of the corresponding circuit without the circuit including any other hardware. Each circuit includes at least some hardware even when the included hardware comprises software.

[0067] Some features are shown stored in a computer readable storage medium (for example, as logic implemented as computer executable instructions or as data structures in memory). All or part of the system and its logic and data structures may be stored on, distributed across, or read from one or more types of computer readable storage media. Examples of the computer readable storage medium may include a hard disk, a floppy disk, a CD-ROM, a flash drive, a cache, volatile memory, non-volatile memory, RAM, flash memory, or any other type of computer readable storage medium or storage media. The computer readable storage medium may include any type of non-transitory computer readable medium, such as a CD-ROM, a volatile memory, a nonvolatile memory, ROM, RAM, or any other suitable storage device. However, the computer readable storage medium is not a transitory transmission medium for propagating signals.

[0068] The processing capability of the system 100 may be distributed among multiple entities, such as among multiple processors and memories, optionally including multiple distributed processing systems. Parameters, databases, and other data structures may be separately stored and managed, may be incorporated into a single memory or database, may be logically and physically organized in many different ways, and may implemented with different types of data structures such as linked lists, hash tables, or implicit storage mechanisms. Logic, such as programs or circuitry, may be combined or split among multiple programs, distributed across several memories and processors, and may be implemented in a library, such as a shared library (e.g., a dynamic link library (DLL)). In some embodiments, the instrument is connected to multiple hospital LIS systems 118 and 116 and each hospital LIS has multiple connections such that the instrument can communicate with multiple LIS environments at multiple hospital LIS systems.

[0069] Bi-Directional Laboratory Information System (LIS)

[0070] The sample-to-answer system may include a bi-directional LIS to automate and accelerate order entry and results reporting. The communication system, such as the LIS communication system, may enable bi-directional reporting. Specifically, when a sample is collected, a physician may create a test order called a physician test order. After the physician test order is generated, the physician test order is sent to the hospital's laboratory information system (LIS), a computer software that processes, stores and manages data from all stages of medical processes and tests. The physician test order is accepted by the Hospital LIS and a pending test order (PTO) is created once the patient sample is received and accessioned by the lab into the hospital LIS. The hospital's LIS sends the PTO to an LIS interchange (associated with the diagnostic instrument), which converts the PTO request from an HL7 (Health Level-7) and / or ASTM (American Society for Testing and Materials) format to a CSV (comma-separated values) format and the PTO is now referred to as a test order, an interchange order, a formatted test order, or a similar term. HL7 and ASTM are a set of standards used in the transfer of information between clinical instruments and Laboratory Information Systems. In this way, the sample-to-answer system is able to communicate with any hospital LIS because the hospital LIS may be driven by multiple standard messaging protocols, such as, e.g., HL7 and ASTM. In the current embodiments, a single diagnostic instrument can connect to a hospital LIS using both HL7 and ASTM. When the LIS interchange receives the PTO and reformats it to a test order, the test order is auto published with information associated with the PTO / sample, such as patient identification, accession number (accession ID), test ordered (e.g., cobas® eplex BCID-GP panel, cobas® eplex BCID-GN panel, and cobas® eplex BCID-FP panel, Roche Diagnostics), patient type (e.g., pediatric, intensive care, and maternity), patient location (e.g., pediatrics, ER, maternity), and / or time stamps, such as sample collection, sample ordering, time received at central receiving, central receiving sort, transport to lab, and / or accession of sample. The PTO may include other identifying information such as ordering clinician, hospital, hospital network, which may be published in the test order. Any information included in the PTO can be used by the instrument as part of the Data Packet Identifier. In some embodiments, the pathogen detector 110 detects a pathogen, gene sequence, or gathers other information from a test cartridge (“detection result”). The pathogen detector 110 sends the detected result to the LIM 111. The LIM 111 applies a DFR from the DFR Database 105 based on the detection result identifier and configures the detection result to form a Configured Detection Result. Based on the DFR, the ISW sends the configured detection result to the LIM 111. Based on the LIM configuration settings (connection type, message format, other extraneous result configurations -such as relevant information and result formatting-, etc.), the LIM sends the configured detection result to the hospital LIS 116. Indeed, there are many settings related to reporting a result from an instrument to the hospital LIM.

[0071] Disclosed is a system allowing a user to customize DFRs, the system comprising: a graphical user interface (GUI) 120 for customizing DFRs comprising: a DFR configuration interface 102. The DFR configuration interface 102 may comprise a first GUI interface comprising (1) the schedule of installed assay panels, (2) the schedule of installed DFRs, (3) a list of specialized DFRs that are unique to the detection instrument, the laboratory, the hospital or geographic region of the laboratory / hospital, (4) DFR recommendations which are DFRs recommended for the detection instrument, the laboratory, the hospital or geographic region of the laboratory / hospital, (5) or combinations thereof. The DFR recommendations can be checked on or off from a drop-down menu. DFRs may be stored in a DFR database 105.

[0072] In some embodiments, the instrument 101 comprises a DFR import module 103, which manages the importation of DFRs from various local (laboratory) and / or remote (hospital) databases to the detection instrument 101. In the illustrated embodiment, the detection instrument 101 comprises a conflict detection and resolution module 104. In some embodiments, the DFR import module 103 comprises the conflict detection and resolution module 104.

[0073] The DFR import module 103 imports Date Forwarding Rules (DRFs). The DFRs may be imported from a local rule database, remote database and / or existing rules already stored on the detection instrument 101. Once imported, the conflict detection and resolution module 104 compares the imported rule to existing rules already stored on the detection instrument 101 and resolves any conflicts. Stated another way, the conflict detection and resolution module 104 merges the new DFR with existing rules already stored on the detection instrument 101 and detects any conflicts which may result from the merge operation. A conflict may result if, for example, the detection result indicates that a result should be forwarded to a LIS Environment with a particular connection method, but the new rule indicates that the same detection result be forwarded to the same LIS Environment with a different connection method. In such a case, the conflict detection and resolution module 104 resolves the conflict using a set of conflict resolution rules (described below). Once all conflicts have been resolved, the data is persisted within the DFR database 105 and made accessible to end users via the DFR manager 106.

[0074] As mentioned above, a conflict detection and resolution module 104 identifies existing rules 105, which match rules being imported from the various sources and attempts to resolve any conflicts, which may exist between the data. In one embodiment, each conflict is identified to the end user and the user is prompted to specify how to resolve the conflict. For example, the graphical user interface 120 may show the user, which rule data contained in the existing rules database 105 conflicts with rule data to be imported to allow the user to correct the conflict.

[0075] In some embodiments, there is a set of conflict resolution rules. For example, a conflict resolution rule can require that the first rule persists, and the imported rule is deleted. A conflict resolution rule can require that the imported rule persists, and the existing rule is deleted. A conflict resolution rule can require that the rule established by the highest ranking rule maker persists (so for example, a rule created by the lab manager persists over a rule created by a lab technician) and the other rule is deleted.

[0076] In one embodiment, the user is given the option to select the existing version 105 or the imported version of the DFR.

[0077] In one embodiment, the various modules shown in FIG. 1 are not separate modules but, rather, separate data structures (e.g., tables) within a relational database.

[0078] In some embodiments, the user or the system identifies one or more “DFR Classes” within the DFR database 105. As described below, DFR Classes are specialized groups of Data Forwarding Rules which have similar application. The concept of a “DFR Class” is a particularly useful abstraction for a detection instrument 101, which runs different types of assays such as Gram positive, Gram negative, fungal or respiratory assays. Some of these assays have unique Data Forwarding Rules and some of these assays have the same Data Forwarding Rules. For example, the gram-negative and gram-positive panels could have some targets, which are the same. If a DFR Class is generated, the target will be treated the same regardless of the assay panel it is on. In one embodiment, a DFR Class is formed when a new DFR matches an existing rule and those rules are for the same target on different panels. In one embodiment, a DFR Class is formed when a new DFR matches an existing rule and those rules are for the same target on different panels and the detection report is reported to the same lab. In some embodiments, to create a DFR Class, the user selects and customizes a DFR to be part of a DFR Class. In one embodiment, this is accomplished with a DFR customization module 107. In one embodiment, the DFR customization module 107 automatically puts repetitive DFRs for different panells into the same DFR Class.

[0079] In some embodiments, the system comprises a DFR customization module 107. The customization module includes, for example, a drop-down menu for selecting DFRs. Alternatively, DFRs may be imported from the DFR import module 103. Rules imported from the DFR import module 103 or defined in the DFR customization module 107 are processed by the DFR conflict detection and resolution module 104. The customization module allows a DFR to be customized by panel, target, selection parameters, laboratory, and / or end client.

[0080] Once a cartridge run is reported to the LIS, the DFR notification module 108 sends an alert notifying the user via a GUI pop-up or via email, text message, instant message, etc. that the result was reported to the appropriate LIS Environment. If reporting fails, the DFR notification module 108 sends a failure notification to the GUI or via email, text message, instant message, etc. that the result was not reported to the appropriate LIS Environment.

[0081] LIS Workflow

[0082] The system may import test orders and export results using more than one of the following methods: Automatically using the ASTM interface to communicate with a connected LIS, such as the LIS Host 116 and automatically using the HL7 v2.3 interface to communicate with a connected LIS such as the LIS Host 116.

[0083] Reconfiguring the First Data Pack

[0084] In some embodiments, the first data pack comprising a Data Packet Identifier is reconfigured into a first outgoing data packet. In some embodiments, first outgoing data packet is delivered to a first LIS Environment. In some embodiments, first outgoing data packet is delivered to a first LIS Environment and a second LIS Environment, wherein the first LIS Environment and the second LIS Environment have different communication protocols, connection methods, relevant information, and / or result formatting requirements or any combinations thereof. In some embodiments, the first outgoing data packet is delivered to a first LIS Environment in a first format and a second LIS Environment in a second format wherein the first format and second format are different.

[0085] In some embodiments, the first data pack is reconfigured into a second outgoing data pack. In some embodiments, the first data pack is reconfigured into a second outgoing data pack when the first data pack comprises a Data Packet Identifier associated with both the first LIS Environment and the second LIS Environment. In some embodiments, the first data pack is reconfigured into a first outgoing data packet and a second outgoing data packet and the first outgoing data packet is delivered to the first LIS Environment the second outgoing data packet is delivered to the second LIS Environment wherein the first LIS Environment and the second LIS Environment are different. In some embodiments, the first data pack is reconfigured into a first outgoing data packet and is delivered to the first LIS Environment then the first data pack is reconfigured into a second outgoing data packet and the second outgoing data packet is delivered to the second LIS Environment, wherein the first LIS Environment and the second LIS Environment are different.

[0086] A Data Packet Identifier is associated with both the first LIS Environment and the second LIS Environment when, for example, a detection result is relevant to both the first LIS Environment and the second LIS Environment. This might happen when, for example, a test result is relevant to both General Laboratory and Point of Care or Microbiology and Core Lab. This might happen when, for example, the test result is a QC result and the result is sent in a first format to the General Laboratory and a second format to the Microbiology Lab. This might happen when, for example, the test result is a gram positive result indicating an outbreak and the result is sent in a first format to the General Laboratory and in a second format to the Microbiology Lab.

[0087] Forwarding data between LIS Environment Interfaces

[0088] In some embodiments, there is provided an apparatus for forwarding data between a LIM and a first LIS Environment and a second LIS Environment, wherein the apparatus comprises a LIM with at least a first LIS environment Interface and a second LIS environment Interface. In some embodiments, the first LIS environment Interface and second LIS environment Interface are not included inside the LIM.

[0089] In some embodiments, there is provided an apparatus for forwarding data between a first LIS Environment and a second LIS Environment, wherein the apparatus comprising: a first LIS Environment interface operatively connected to the first LIS Environment and a second LIS Environment interface operatively connected to the second LIS Environment wherein when the first LIS Environment interface receives a first data packet. The first LIS Environment interface evaluates the first data packet and if it comprises a Data Packet Identifier associated with the first LIS Environment it reconfigures the first data pack into a first outgoing data pack and delivers the first outgoing data pack to the first LIS Environment. If the data packet comprises a Data Packet Identifier associated with the second LIS Environment, the first LIS Environment interface forwards the data packet to the second LIS Environment interface. The second LIS Environment interface reconfigures the first data pack into a second outgoing data pack and delivers the second outgoing data pack (aka reconfigured first data pack) to the second LIS Environment.

[0090] Computer program

[0091] In some embodiments, a computer program is provided, which may comprise a memory having embodied thereon statements and instructions for execution by a computer, thereby causing the computer to perform a method for reconfiguring data packets and forwarding reconfigured data packets to a first LIS Environment and a second LIS Environment. The method may comprise the steps of receiving a first data packet, the first data packet comprising a first information set associated with the first LIS Environment; reconfiguring the first data packet into a first outgoing data set; receiving a second data packet, the second data packet comprising a second information set associated with the second LIS Environment, wherein the first information set and second information set are different and wherein the first LIS Environment and second LIS Environment are different; reconfiguring the second data packet into a second outgoing data set; and delivering to the first LIS Environment the first outgoing data set and delivering to the second LIS Environment the second outgoing data set.

[0092] Further provided is a method and apparatus for forwarding data packets between two networks. More specifically, provided is a method and apparatus for forwarding two different data packets to two different LIS Environments. Each data packet includes a Data Packet Identifier. The Data Packet Identifier includes adequately encoded information to be configured and conveyed by the LIM to the correct LIS Environment. The LIM reads the Data Packet Identifier and configures the first data pack with the correct LIS Environment formatting. The LIM reads the Data Packet Identifier and configures the first data pack with the correct LIS Environment communication protocol (e.g., ASTM or HL7). The LIM reads the Data Packet Identifier and configures the first data pack with the correct LIS Environment connection method (e.g., TCP / IP or Serial). The LIM reads the Data Packet Identifier and configures the first data pack with the correct LIS Environment relevant information. The LIM reads the Data Packet Identifier and configures the first data pack with the correct LIS Environment result formatting. The LIM reads the Data Packet Identifier and configures the first data pack with combinations of the correct LIS Environment communication protocol (e.g., ASTM or HL7), connection method (e.g., TCP / IP or Serial), relevant information, result formatting, and / or other extraneous result configurations.

[0093] The method may further comprise receiving one or more first outgoing data packets by a first LIS Environment that includes the correct LIS Environment Information Packets. The method may further comprise receiving one or more second outgoing data packets by a second LIS Environment that includes the correct LIS Environment Information Packets.

[0094] The method may further comprise reconfiguring by the LIM the first data packet that is destined for a second LIS Environment into second outgoing data packet that has a different configuration than the first outgoing data packet. Each second outgoing data packet includes second LIS Environment Information Packets.

[0095] Data Forwarding Rule

[0096] In some embodiments, the LIM configures data packs based on data forwarding rules (DFRs). The

[0097] DFRs can be stored in the DFR Database 105, which is part of or separate from the LIM 111. Each Data Forwarding Rule (“DFR”) defines if and how identifiers of data packets are to be forwarded to various LIS Environments, how data packs correlate with each other (if at all), and how the identifiers are to be mapped when a data packet is configured and forwarded to an LIS Environment. In some embodiments, a Data Forwarding Rule evaluates a first Data Packet Identifier associated with a first LIS Environment, and a second Data Packet Identifier associated with a second LIS Environment. In some embodiments, a DFR may be configured to convey the first data packet to a second LIS Environment.

[0098] Data forwarding rules according to embodiments may be reversible or invertible. For example, a DFR may be configured to map packets from the first LIS Environment to the second LIS Environment, and the same DFR may be configured to map packets from the second LIS Environment to the first LIS Environment by reversing mappings.

[0099] The method further includes rules for forwarding the one or more second data packets to a third LIS Environment.

[0100] Connections for LIS environments

[0101] Fig. 1 shows a LIS 116 with multiple connections to a detection device 101. Each LIS connection creates a unique LIS environment with unique reporting parameters. As illustrated, the first LIS Environment 116 is configured as a wireless network but can be configured in many other wireless or wired ways as would be readily understood. The first LIS 116 includes one or more wireless receiving stations, which can be terrestrial or satellite based.

[0102] A method for forwarding outgoing data packages may be employed in a detection instrument, which may comprise a gateway, router, network address translation (NAT) device, or a gateway GPRS (general packet radio service) support node (GGSN), for example. The networks connected by the apparatus may be wired or wireless networks, local area networks (LAN), wide area networks (WAN) or other generic, application-specific, user-specific or geography-specific networks, as would be readily understood by a person skilled in the art. The networks may be configured based on a number of interconnect systems and communication protocols.

[0103] Methods for Forwarding outgoing Data Packets

[0104] In some embodiments, the Data Forwarding Rule can automatically forward first data packets comprising a First Data Packet Identifier to a first LIS Environment and a Second Data Pack comprising a Second Data Pack Identifier to a second LIS Environment. In some embodiments, the first data packets is equal or different from the second data packets. In some embodiments, the first Data Packet Identifier is equal to or different from the second Data Packet Identifier. In some embodiments, the first data packet is converted to a first outgoing data packet and the second data packet is converted to a second outgoing data packet and the first and second outgoing data packets are equal to or different from to one another. In some embodiments, the outgoing data packets comprise LIS Environment Information Packets. In some embodiments, the first LIS Environment Information Packets is equal to or different from the second LIS Environment Information Packets. In some embodiments, different information is transferred to the first LIS Environment and second LIS Environment. In some embodiments, the first LIS Environment Information Packets is delivered to the first LIS Environment and the second LIS Environment Information Packets is delivered to the second LIS Environment. In some embodiments, the first LIS Environment Information Packets is only capable of being delivered to the first LIS Environment and the second LIS Environment Information Packets is only capable of being delivered to the second LIS Environment. In some embodiments, the first LIS Environment Information Packets is only capable of being delivered to the first LIS Environment and the second LIS Environment Information Packets is delivered to the second LIS Environment but is capable of being delivered to multiple LIS environments.

[0105] The method can further be configured so that the second LIS Environment equals the first LIS Environment. In such situations, the same information is transferred to the first LIS Environment and second LIS Environment. In some embodiments, the first LIS Environment Information Packets is delivered to the first LIS Environment and the first LIS Environment Information Packets is delivered to the second LIS Environment. In some embodiments, a first set of information is delivered to the first LIS Environment and the first set of information is delivered to the second LIS Environment but wherein the a first set of information has different configurations depending on the LIS Environment it is delivered to.

[0106] Third LIS Environment

[0107] In some embodiments, the LIM may be configured to process one or more third data packets received from the ISW. The third data packet may comprise a third Data Packet Identifier. In some embodiments, the third data packet may comprise a Data Packet Identifier, which is the same as the first Data Packet Identifier. In some embodiments, the third data packet may comprise a Data Packet Identifier, which is the same as the second Data Packet Identifier. In some embodiments, the third data packet may comprise a Data Packet Identifier, which is the same as the first and second Data Packet Identifier. In some embodiments, the third data packet may comprise a Data Packet Identifier, which is the different from the first Data Packet Identifier. In some embodiments, the third data packet may comprise a Data Packet Identifier, which is the different from the second Data Packet Identifier. In some embodiments, the third data packet may comprise a Data Packet Identifier which is the different than the first and second Data Packet Identifier. In some embodiments, a Data Forwarding Rule can be employed to map the third data packet to the first LIS Environment, the third LIS Environment or both.

[0108] Apparatus for Forwarding Data Packets

[0109] In some embodiments there is provided a LIM operatively connected to a first LIS Environment and a second LIS Environment to exchange data between the LIM and the two LIS Environments. In some embodiments, the LIM comprises a first LIS Environment interface 123 operatively connected to the first LIS Environment. The first LIS Environment interface is configured for receiving one or more first Data Packets from the ISW. The first LIS Environment interface is configured for delivering one or more first LIS Environment Information Packets to the first LIS Environment.

[0110] The LIM comprises a second LIS Environment interface operatively connected to the second LIS Environment for delivering one or more second LIS Environment Information Packets to the second LIS Environment. The second LIS Environment interface is configured for receiving one or more second Data Packets from the ISW.

[0111] The LIM comprises a N- LIS Environment interface operatively connected to the N- LIS Environment. The N- LIS Environment interface is configured for receiving one or more N- Data Packet Identifiers from the ISW. The N- LIS Environment interface is configured for delivering one or more N- LIS Environment Information Packets to the N- LIS Environment. Where N equals a number.

[0112] In some embodiments, the LIM is a packet-processing system or comprises a packet-processing system configured to reconfigure / configure a first data packet into one or more second data packets, one or more outgoing data packets or both using one or more Data Forwarding Rules. FIG. 2 illustrates a sequence diagram 200 of data packet flow. It is noted that FIG. 2 illustrates the data flow between the diagnostic instrument 101 and the LIS Environment 116 (LIS environment no. 1 and LIS Environment no. 2) as an example for the data flow between the instrument and LIS Environments.

[0113] As illustrated, the instrument processes a cartridge 210 and sends a first Data Packet to the instrument LIM 220. The LIM 220 evaluates if a Data Packet Identifier / DFR applies 250. The LIM then configures the results 230 based on the Data Packet Identifier / DFR. Upon determining that the data packet has a Data Packet Identifier / DFR destined for the First LIS Environment, the results are configured for and sent to the first LIS Environment 240 based on the Data Packet Identifier / DFR. In some embodiments, the instrument processes a cartridge 210 and sends a second Data Packet to the instrument LIM 220. The LIM 220 evaluates if a Data Packet Identifier / DFR applies 250. The LIM then configures the results 250 based on the Data Packet Identifier / DFR. Upon determining that the data packet has a second Data Packet Identifier 250 destined for the second LIS Environment, the results are configured for and sent to the second LIS Environment 270 based on the Data Packet Identifier / DFR. In some embodiments, the LIM auto configures results without reference to a DFR. In some embodiments, the LIM auto configures results without reference to a Data Packet Identifier. In some embodiments, the LIM auto configures results with reference to a Data Packet Identifier and DFR. In some embodiments, the LIM auto configures results with reference to a DFR and without reference to the Data Packet Identifier.

[0114] Fig. 7 is similar to Fig 2 but instead of two data packets, the single data packet 750 is received from the Instrument (710 and 720). The Data Packet has a DFR and / or Data Packet Identifier, which signals to the LIM to configure the result to be sent to a First LIS environment and a Second LIS Environment (730, 740, 760 and 770).

[0115] A DFR forwards a detection result based on a rule, z.e., the result is processed through a rule database. A result may have multiple DFR’s applied to it such that a result if forwarded to more than one LIS Environment. When a result is forwarded based on a Data Packet Identifier the result is forwarded without reference to a DFR, z.e., just on the result itself. As such, in some embodiments, step 250 / 251 are skipped and the results are configured based on the Data Packet Identifier. The configured results are then sent to the appropriate LIS Environment 240 / 280.

[0116] In some embodiments, the detection result is configured and forwarded to the first LIS Environment 240 by default. In some embodiments, the detection result is only forwarded to an LIS Environment other than the first LIS Environment 240 if it there is a DFR associated with the detection result / Data Packet Identifier. In some embodiments, the system may be configured to configure / forward the results even if a corresponding Data Forwarding Rule was not previously activated.

[0117] For example, the system may be configured to activate a Data Forwarding Rule in response to a receipt of particular detection result. For example, if a result indicates that there may be an outbreak in a particular region, the system can be configured to activate a corresponding Data Forwarding Rule in response to receipt of that particular result so that results indicative of an outbreak reach the General Laboratory faster than if they are not automatically forwarded. Further, the scope of a particular rule may be set to be only applicable for a certain time period (for example special Data Forwarding Rule during an outbreak). Similarly, the instrument can be configured to designate certain results as “high priority” (e.g., a positive test result for a highly contagious disease where the patient must be quarantined). The system can be configured to activate a corresponding Data Forwarding Rule in response to receipt of that particular result so that results indicative of an outbreak reach the Point of Care faster.

[0118] Establishing Rules

[0119] In some embodiments, one or more Data Forwarding Rules may be activated automatically by the device 110 or a subset of pre-established Data Forwarding Rules be activated automatically, or no pre-established Data Forwarding Rules may be activated automatically. In some embodiments, the client (hospital, laboratory, office) establishes the Data Forwarding Rules.

[0120] FIG. 3 illustrates how the LIM 303 uses the result 302 from the instrument 301 comprising a Data Packet Identifier and configures the result 304 into a LIS Environment Information Packet so that it (outgoing data packet 305) can be forwarded to correct LIS Environment 306.

[0121] In some embodiments, the result is only forwarded if the LIS Environment Information Packet matches the LIS Environment requirements. In some embodiments, the result is only forwarded if the LIS Environment Information Packet matches at least some aspect of the LIS Environment requirements. In some embodiments, the result may be forwarded even if the LIS Environment Information Packet does not match the LIS Environment requirements. In some embodiments, the result is only forwarded to the LIS Environment if the Data Forwarding Rule has been previously activated.

[0122] In some embodiments, communication between the instrument and a first LIS Environment may occur independently from communications between the instrument and a second LIS Environment. In some embodiments, communication between the instrument and a second LIS Environment may occur only if communication is established with the first LIS Environment. In some embodiments, if communication between the instrument and a first LIS Environment is blocked / stopped then communications between the instrument and a second LIS Environment is stopped. In some embodiments, if communication between the instrument and a first LIS Environment is blocked / stopped then communications between the instrument and a second LIS Environment is not stopped.

[0123] In some embodiments, one or more of the described communications between the instrument and a first LIS Environment and a second LIS Environment may be performed substantially at the same time. In some embodiments, the described communications between the instrument and a first LIS Environment and a second LIS Environment may be performed serially (one after the other). Creating a New DFR

[0124] When a laboratory receives a new diagnostic instrument or a new assay panel, it may create Data Forwarding Rules. After navigating to the system setup (FIG. 6 at step 601), the user may select between managing Data Forwarding Rules (FIG. 6 at 603) or creating a new Data Forwarding Rule (FIG. 6 at step 602). The system setup may be a drop-down menu in the GUI that allows a user to create or manage Data Forwarding Rules. Selecting an item from a list of options (“Drop down menu”) is a common function of software user interfaces. As a user selects options from a dropdown menu, the subsequent items available for selection in the user interface changes.

[0125] In some embodiments, the system receives the user’s selection when the user clicks on the Create a new Data Forwarding Rule button (FIG. 6 at step 602). In some embodiments, the system receives a user selection when the user clicks on the Manage Data Forwarding Rules button (FIG. 6 at step 603). From there, the system receives the user’s selection when the user clicks on an “edit” button for an assay panel (not shown in FIG. 6) to configure rules specifically for that panel. In some embodiments, only those assays that have a Data Forwarding Rule defined appear in the manage Data Forwarding Rules screen. In some embodiments, all the assays that could have a Data Forwarding Rule defined appear in the manage Data Forwarding Rules screen whether or not a rule has been created already.

[0126] In some embodiments, after the system receives the user’s selection to "create a new Data Forwarding Rule" (FIG. 6 at step 602) the system will display a dropdown in the GUI, which contains all of the installed assays on the system, aka the assay dropdown and also referred to as the "Create a New DFR Assay Menu." In some embodiments, the system receives the user’s selection of an installed assay 602.1. In some embodiments, the assay dropdown contains only those assays installed on the system. For example, if the system only has a respiratory (RP) assay installed on the system, then only the RP assay is displayed in the assay dropdown. In some embodiments, only those assays installed on the system are preloaded into the assay dropdown.

[0127] In some embodiments, the assay dropdown (Create a New DFR Assay Menu) contains all the assays that could be installed on the system. For example, if the user only has an RP assay installed on the system but could have RP and a gram-positive, gram-negative, or a fungal assay installed, all will be displayed. Even if a user has not purchased a blood culture panel, the gram-positive, gram-negative, and fungal assays will still appear in the Create a New DFR Assay Menu.

[0128] In some cases, each assay has a unique colored tag, and the assay dropdown color tag matches the color tag of the assay.

[0129] In FIG. 6, at step 602.1, the system receives the user selection of an installed assay (e.g., RP, grampositive, gram -negative, or fungal). Once the user selects an assay from the Create a New DFR Assay Menu (602.1), the system displays the LIS Environment Information Packets options (“LIS Option Display”) 602.2 in the GUI which contains all of the selected target’s DATA FORWARDING RULE details such as communication protocol (ASTM or HL7), connection method (TCP / IP or Serial), relevant information, and formatted results. In some embodiments, the LIS Environment Information Packets options are grayed out or blank. In some embodiments, the LIS Environment Information Packets options are hidden until a user selects specific information. For example, in the LIS Option Display the results format is hidden until the user selects a communication protocol. Once a communication protocol is selected the option to select a result format appears in the LIS Option Display.

[0130] Communication protocol (ASTM or HL7)

[0131] In the LIS Option Display, the user selects a communication protocol (stated another way, the detection instrument receives a user selection). In some embodiments, the communication protocol options are a toggle between ASTM or HL7, z.e., when ASTM is selected HL7 is not selected and vice versa. In some embodiments, the communication protocol options are push buttons and the user must press the ASTM or HL7 button but both cannot be selected at the same time. In some embodiments, the communication protocol options contain configurable values (e.g. On / Off) for ASTM or HL7 (both cannot be on or off at the same time).

[0132] Connection method (TCP / IP or Serial)

[0133] In the LIS Option Display, the user selects a communication method (stated another way, the detection instrument receives a user selection). In some embodiments, the communication protocol options are a toggle between TCP or IP / Serial, z.e., when TCP is selected IP / Serial is not selected and vice versa. In some embodiments, the communication protocol options are push buttons and the user must press the TCP or IP / Serial button, but both cannot be selected at the same time. In some embodiments, the communication protocol options contain configurable values (e.g. On / Off) for TCP or IP / Serial (both cannot be on or off at the same time).

[0134] Relevant information

[0135] In the LIS Option Display, the user selects relevant information (stated another way, the detection instrument receives a user selection). In some embodiments, the relevant information options are prepopulated. In some embodiments, the relevant information options are not prepopulated. In situations where the relevant information options are prepopulated the user can select which prepopulated options it wants to select. In some embodiments, all of the prepopulated options are pre-selected for inclusion. In some embodiments, all of the prepopulated options are pre-selected for exclusion. In some embodiments, a first portion of the prepopulated options are pre-selected for inclusion and a second portion of the prepopulated options are pre-selected for exclusion.

[0136] Some prepopulated “relevant information” options include the following:

[0137] Timeout duration between when the system says a connection (between the hospital LIS and Instrument) is no longer active. This timeout can be configured to user specifications.

[0138] Sending Facility ID which is used as a device identifier in the configured result message when sending results from the instrument to the hospital LIS system. This ID can be configured to user specifications.

[0139] Serial Port Settings are provided default settings which may be modified to the needs of the user. These default settings are applicable to COM port, Baud rate, Data Bits, Parity, DTR / RTS enabled status, Stop Bits and Enabling DSR Query.

[0140] Formatted results

[0141] In the LIS Option Display, the user selects the format for results (stated another way, the detection instrument receives a user selection). In some embodiments, the format for results options are prepopulated. In some embodiments, the format for results options are not prepopulated. In situations where the format for results options are prepopulated the user can select which prepopulated options it wants to select. In some embodiments, all of the prepopulated options are selected for inclusion. In some embodiments, all of the prepopulated options are selected for exclusion. In some embodiments, a first portion of the prepopulated options are selected for inclusion and a second portion of the prepopulated options are selected for exclusion.

[0142] Some prepopulated options include the following: report only detected targets, report only detected targets and controls, report all results, or report all results for that panel but not any pan targets or off-panel targets (z.e., when a gram positive cartridge includes gram negative targets).

[0143] In one embodiment, when a new Data Forwarding Rule is entered by a user it is automatically added to the Data Forwarding Rule database 105.

[0144] After the system receives the user’s selection of LIS Environment Information Packets options (602.2), the system sends a confirmation of the DFR to the LIS (602.3).

[0145] Creating DFR can be further understood by the following numbered paragraphs:

[0146] Paragraph 1. A method for creating a Data Forwarding Rule on a detection instrument, the method comprising: receiving by the detection instrument a user selection of a first installed assay; receiving by the detection instrument the user selection of a first LIS Environment Information Packets option. Paragraph 2. The method for creating a Data Forwarding Rule on a detection instrument of claim 1, further comprising: receiving by the detection instrument the user selection of a second LIS Environment Information Packets option.

[0147] Paragraph 3. The method for creating a Data Forwarding Rule on a detection instrument of any preceding paragraph, wherein the formatting results option is not displayed until the system receives the user’s selection of a communication protocol.

[0148] Paragraph 4. The method for creating a Data Forwarding Rule on a detection instrument of any preceding paragraph, further comprising: receiving by the detection instrument the user selection of a second installed assay; receiving by the detection instrument the user selection of at least one LIS Environment Information Packets option for the second installed assay.

[0149] Paragraph 5. A method for creating a Data Forwarding Rule on a detection instrument, the method comprising: providing by the detection instrument a assay display drop-down wherein there are no installed assays; displaying by the detection instrument “there are no installed assays”; and preventing by the detection instrument the user from creating a DFR rule.

[0150] Paragraph 6. A method for creating a Data Forwarding Rule on a detection instrument, the method comprising: providing by the detection instrument an assay display drop-down wherein there is at least one installed assay and at least one installed DFR for the assay; displaying by the detection instrument an assay drop down comprising the DFR for the selected assay; and displaying by the detection instrument a “create a new DFR button” and a “manage a DFR button.” Paragraph 7. A method for creating a Data Forwarding Rule on a detection instrument, the method comprising: automatically populating, by the detection instrument, a DFR for an installed assay.

[0151] Paragraph 8. A diagnostic instrument for strengthening a healthcare provider's quality program comprising: a diagnostic instrument having a processor, memory, and access to computer readable media; a computer program stored on computer readable media having a Reporting Results module; and a user interface displayed on a monitor for interaction with said computer program.

[0152] Paragraph 9. The diagnostic instrument of paragraph 8, further comprising a network connection between the diagnostic instrument and a computer network for allowing remote access to the computer program.

[0153] Simulating results

[0154] In some embodiments a simulated result can be created. A simulated result is not intended for clinical diagnostic purposes and only for testing connections and configurations between the instrument and hospital LIS system.

[0155] DFR can be generated for each target

[0156] In some embodiments, a DFR cannot be generated for each target on the assay panel. In some embodiments, notably with a simulated result, a DFR can be generated for each target on the assay panel (not shown). In some embodiments, after selecting an assay from the Assay Dropdown, a Target Dropdown will be displayed in the GUI which contains all of the targets for the selected assay. In some embodiments, the Target Dropdown contains only those targets for the selected assay. For example, if the user has selected the respiratory (RP) assay, then only the RP targets are displayed in the Target Dropdown. In some embodiments, all of the targets for all of the assays installed on the system are displayed in the Target Dropdown.

[0157] In some embodiments, the targets on the assay panel are further displayed in the Target Dropdown with the expected or predicted result. In some embodiments, each target’s expected result is not detected, and each target will be marked "Not Detected". In some embodiments, each target’s expected result is "Detected" and each target will be marked "Detected." In some embodiments, a first plurality of targets will be marked "Not Detected," and a second different plurality of targets will be marked "Detected." In some embodiments, the user creates a default expected result to be used for all DFR operations, z.e., detected or not detected. In some embodiments, the user can generate a unique expected result for each Data Forwarding Rule.

[0158] If the user wishes to include a customized expected result in lieu of the default expected result for one or more Data Forwarding Rules, then the user selects a Data Forwarding Rule and enters the customized result for the Data Forwarding Rule. This step can be repeated if any additional customized expected results are to be included.

[0159] In some embodiments, the user selects a target (not shown) such as for example, Adenovirus, Coronavirus (229E, HKU1, NL63, OC43), Human Metapneumovirus, SARS-CoV-2, Human Rhinovirus / Enterovirus, Influenza A, Human RhinovirusZEnterovirus, Influenza A Hl, Influenza A Hl-2009, Influenza A H3, Influenza A Hl-2009, Influenza B, Parainfluenza 1, Influenza B, Parainfluenza 2, Parainfluenza 3, Parainfluenza 4, Respiratory Syncytial Virus A, Respiratory Syncytial Virus B, Chlamydia pneumoniae, Mycoplasma pneumoniae, or Chlamydia pneumoniae (stated another way, the detection instrument receives a user selection). In some embodiments, the user does not need to select a target, they can proceed to the next step without making a selection. In some embodiments, the Target Detail Dropdown contains only target information for the selected target. In some embodiments, the Target Detail Dropdown contains only target information for the selected target that has been populated. For example, if the user has selected Parainfluenza 3 from the respiratory assay and only the expected result is known, then only the expected result for Parainfluenza 3 is displayed.

[0160] Manage Data Forwarding Rules

[0161] After a Data Forwarding Rule has been created (Step 602 in FIG. 6), it can be managed (Step 603 in FIG. 6).

[0162] After navigating to system setup (FIG. 6 at step 601), the user selects between creating a new Data Forwarding Rule (FIG. 6 at step 602) or managing Data Forwarding Rule (FIG. 6 at 603) from the system setup dropdown.

[0163] In some embodiments, selecting “Manage Data Forwarding Rule” (FIG. 6 at 603) will produce a Manage Data Forwarding Rule Dropdown which displays assays with Data Forwarding Rules set up on the system. This is the “Manage Data Forwarding Rule Menu.” The Manage Data Forwarding Rule Menu reflects the most recent rule parameters (communication protocol (ASTM or HL7), connection method (TCP / IP or Serial), relevant information, formatted results and combinations thereof). In some embodiments, each installed assay has a corresponding colored assay tag and the same color is used in the GUI when the assay name is displayed.

[0164] In some embodiments, selecting "Manage Data Forwarding Rule" (FIG. 6 at step 603) will produce an Installed Assay Manage Data Forwarding Rule Dropdown which contains the installed assays on the system (e.g., RP2, gram-positive, gram-negative, or fungal). The user selects the installed assay (FIG. 6 at 603.2) (stated another way, the detection instrument receives a user selection) and then a second drop-down menu appears which contains the Data Forwarding Rule(s) that have been set up on the system for that assay (the Manage Data Forwarding Rule Menu) and the user selects the Data Forwarding Rule (FIG. 6 at 603.2). In some embodiments, if there is only one Data Forwarding Rule set up on the system, step 603.3 is skipped. Step 603.3 can also be skipped if, as in some embodiments, selecting "Manage Data Forwarding Rule" (FIG. 6 at step 603) produces an assay dropdown which contains all of the Data Forwarding Rule(s) that have been set up on the system.

[0165] Once the user selects a DFR (FIG. 6 at step 603.3) (stated another way, once the detection instrument receives a user target selection) the user can change the rule such as communication protocol, connection method, relevant information and / or result formatting (FIG. 6 at step 603.4). As with creating a rule, when editing a rule, the system sends a DFR notification update to the LIS (603.5).

[0166] In some embodiments, (when creating a Data Forwarding Rule or managing a Data Forwarding Rule) if all of the assays do not have a DFR, an alarm will sound or an alert will be given. In some embodiments (when creating a Data Forwarding Rule or managing a Data Forwarding Rule), if any assays have a duplicated DFR, an alarm will sound or an alert will be given. In some embodiments, it is possible to give two assays duplicate DFRs. In some embodiments, an alert is a warning sound, email, text message, instant message, etc.

[0167] In some embodiments, the user selects the "Apply" button when they are done editing the DFR for the assay panel. In some embodiments, the edited Data Forwarding Rule is automatically saved by the instrument.

[0168] In some embodiments, not every LIS Environment Information Packets can be changed. For example, in some embodiments, if the assay selected is fungal, the communication protocol must be HL7.

[0169] In some embodiments, when the manage Data Forwarding Rule is selected from the system setup dropdown, the user can perform one or more of the following: view all Data Forwarding Rule, view run history (a report of the data forwarding rules executed for that assay or panel), reset DFR start date, reset DFR end date, duplicate Data Forwarding Rule, and / or delete a Data Forwarding Rule.

[0170] Editing DFR can be further understood by the following numbered paragraphs:

[0171] Paragraph 1. A method for managing Data Forwarding Rules on a detection instrument, the method comprising: displaying by a detection instrument a Data Forwarding Rules; receiving by the detection instrument a user modification to a first Data Forwarding Rule; processing by the instrument a sample according to the modifications to the first Data Forwarding Rule.

[0172] Paragraph 2. The method for managing Data Forwarding Rules on a detection instrument of paragraph 1, wherein modifications comprises changing the communication protocol, connection method, relevant information and / or result formatting to a different value.

[0173] Editing a DFR As a Supervisor

[0174] In some embodiments, different control features can only be changed by someone with the proper credentials, such as a supervisor or administrator. In FIG. 6, there is a step before step 603.1 (select an installed assay) or before step 603.3 (select a DFR), or before step 603.4 (change LIS Environment Information Packet information). In these embodiments, the system will ask the supervisor to enter a passcode or scan a badge before selecting an installed assay, selecting a DFR, or changing a DFR. After the supervisor has entered the passcode or swiped a badge, they can select an installed assay and proceed through the steps to manage a DFR. In some embodiments, if the supervisor does not enter a passcode or swipe a badge, the DFR cannot be changed.

[0175] Delete DFR

[0176] In some embodiments, a DFR can be deleted. This can be accomplished at the individual rule level, or as part of a bulk action.

[0177] Delete an Individual DFR

[0178] After navigating to the system setup (FIG. 6 at step 601), the user selects between creating a new DFR (FIG. 6 at step 602), managing DFRs (FIG. 6 at 603) or deleting DFRs (FIG. 6 at 604) from the system setup dropdown.

[0179] From the manage DFRs (FIG. 6 at step 601) drop-down, the user selects Delete DFR (FIG. 6 at step 604) to delete an DFR. In some embodiments, selecting “Delete DFR” (FIG. 6 at step 604) will produce an assay dropdown which contains a list of all the installed assays that have a DFR. (FIG. 6 at step 604.1). The user selects the DFR (FIG. 6 at step 604.2) and deletes it (FIG. 6 at step 604.3).

[0180] To Delete Multiple DFRs:

[0181] From the manage DFRs (FIG. 6 at step 601) drop-down, the user selects Delete DFR (FIG. 6 at step 604) to delete all of the DFRs associated with an assay panel.

[0182] In some embodiments, the user selects the assay (FIG. 6 at step 604.1) and deletes it (FIG. 6 at step 604.3). Stated another way, the detection instrument receives a user assay selection (FIG. 6 at step 604.1) and instructions to delete it (FIG. 6 at step 604.3).

[0183] If a DFR is deleted and there is no remaining DFR for the assay, the assay changes to red on the drop down. If a user attempts to navigate away from the DFR tab without applying a DFR to the assay, a dialogue appears stating "DFRs for the highlighted assays have been disabled. Please use Manage DFRs to correct the data forwarding rules." The user may leave the system setup page (FIG. 6 at step 604.5), or add a DFR for the panel (FIG. 6 at step 604.6).

[0184] Deleting DFRs can be further understood by the following numbered paragraphs:

[0185] Paragraph 1. A method for deleting a Data Forwarding Rule on a detection instrument, the method comprising: selecting from a startup menu a first installed assay; selecting a first DFR for the first installed assay; and deleting the first DFR.

[0186] Viewing Multiple DFRs

[0187] After navigating to the system setup drop down (FIG. 6 at step 601), the user selects an assay (FIG. 6 at step 605.1) and views all the DFRs associated with it (FIG. 6 not shown).

[0188] Enabling / disabling DFR

[0189] After navigating to the system setup drop down (FIG. 6 at step 601), the user selects between creating a new DFR (FIG. 6 at step 602), managing DFRs (FIG. 6 at 603) deleting DFRs (FIG. 6 at 604), viewing DFRs (FIG. 6 at 605) or enabling / disabling DFRs (FIG. 6 at 606) from the system setup dropdown.

[0190] From the manage DFRs (FIG. 6 at step 601) drop-down, the user selects enable / disable DFR (FIG. 6 at step 606) to enable / disable a DFR. In some embodiments, selecting “Enable / Disable DFR” (FIG. 6 at step 606) will produce an assay dropdown which contains a list of all the installed assays that have a DFR. (FIG. 6 at step 606.1). The user selects the DFR (FIG. 6 at step 606.2) and enables / disabled it (FIG. 6 at step 606.3). In some embodiments, the user can select more than one DFR to enable or disable. In one embodiment, a first DFR is enabled and a second DFR is disabled. In one embodiment, a first DFR is enabled and a second DFR is enabled. Stated another way, the detection instrument receives a user assay selection (FIG. 6 at step 606.1), receives a user rule selection (FIG. 6 at step 606.2), and receives a user instructions to enable / disable (FIG. 6 at step 606.3).

[0191] In some embodiments, a DFR that has been disabled is still viewable in the GUI.

[0192] Summary Report

[0193] The method further includes generating a Summary Report of data forwarding results. After the samples, QC cartridges and / or cleaning cartridges are run, the report generator 121 generates a Summary Report. A Summary Report may be generated by a remote computing device or the processing instrument. The Summary Report identifies the cartridge run (assay, QC), the results for each target, and where the result was forwarded to, z.e., General Laboratory, Microbiology, Core Lab, Point of Care, etc. The data sharing module 122 then shares the Summary Report by presenting it through a network accessible interface (i.e., GUI) or transmitting it through other forms of communication including email, text message, instant message, etc. The Summary Report may be a printout generated by a printing device (e.g., a printer) or a digital document that is viewed on a screen and / or securely transferred (e.g., via email, text message, instant message, etc.) to a healthcare professional, laboratory supervisor, FDA, etc. Quick view

[0194] In some embodiments, when a user selects a DFR from the startup screen, they are presented with a “Quick View” option.

[0195] In some embodiments, the “Quick View” displays all relevant details of the DFR (communication protocol, connection method, relevant information, and result formatting) with added ability to export or print. In some embodiments, when export is selected, the Export File Explorer is presented to allow the user to select a destination. In some embodiments, when the Print icon is selected, a pull-up-list is presented to either Print Details or Print a summary of the DFR rules.

[0196] Apparatus

[0197] The disclosed apparatus may be a specialized device like a diagnostic device or a modified nucleic acid testing (NAT) device, routing device, firewall device, gateway, server, or the like. The apparatus may comprise one or more network interfaces operatively coupled to one or more processors, as well as memory, software, firmware, a power source, other hardware, and / or the like, configured together to implement the methods disclosed herein.

[0198] FIG. 4 illustrates a system 400 for forwarding data to a first LIS Environment and a second LIS Environment. The apparatus 430 comprises a first LIS Environment interface 410 operatively coupled to a first LIS Environment 415. The first LIS Environment interface 410 may comprise a plurality of connections to a first LIS Environment 415 for reception of data therefrom, and also for transmission of data thereto. Data may include data packets and test orders, for example. The physical connection may be a wired, optical, wireless, or other connection. Information exchange may proceed in accordance with one or more appropriate communication standards, such as standards of one or more OSI layers, as would be readily understood by a worker skilled in the art. The first LIS Environment interface 410 may further comprise memory, such as one or more FIFO or priority queues, as well as interface control hardware, software, and / or firmware for facilitating operation of the first LIS Environment interface 410. The first LIS Environment interface 410 is configured to receive first data packets from the apparatus 430.

[0199] The apparatus 430 also comprises a second LIS interface 420 operatively coupled to a second LIS Environment 425. The second LIS interface 420 may comprise a plurality of connections to a second LIS Environment 425, and for transmission of data thereto, and also for reception of data therefrom. Data may include both data packets and test orders, for example. The physical connection may be a wired, optical, wireless, or other connection. Information exchange may proceed in accordance with one or more appropriate communication standards, such as standards of one or more OSI layers, as would be readily understood by a worker skilled in the art. The second LIS interface 420 may further comprise memory, such as one or more FIFO or priority queues, as well as interface control hardware, software, and / or firmware for facilitating operation of the second LIS interface 420. The second LIS interface is configured to transmit second data packets to the second LIS Environment.

[0200] The apparatus 430 also comprises a data packet processing system (LIM) which may form part of the processor 435 operatively coupled to the first LIS Environment interface 410 and the second LIS interface 420. The data packet processing system 435.1 as illustrated forms part of a processor 435 such as one or more microprocessors, the processor 435 operatively coupled to memory 440 such as solid state memory. The apparatus 430 may also comprise other components, such as one or more memory arrays (not illustrated) configured for enqueueing packets. The memory array, if present, is operatively coupled to the processor 435 and data packet processing system 435.1 which may modify packet information, such as addresses or port numbers thereof or communication protocol (e.g., ASTM or HL7), connection method (e.g., TCP / IP or Serial), relevant information, formatted results and combinations thereof. Alternatively, equivalent electronic, optronic, or electro-optical components may be provided. Alternatively, the processor 430 may operate on packets enqueued in the first LIS Environment interface 410 or second LIS interface 420. Memory 440 may contain DFRs and software or instructions for operating the apparatus and / or data packet processing system. In some embodiments, the processor 435 may implement DFRs held in the memory 440 and may implement said DFRs as appropriate. The data packet processing system 435.1 is configured at least to process data packets received from the apparatus and to configure data packets into first data packets or second data packets for transmission by the first LIS interface 410 or second LIS interface 420 to the First LIS Environment and Second LIS Environment respectively.

[0201] In some embodiments, the data packet processing system 435.1 is configured to process data packets received from the apparatus and to configure data packets into first data packets or second data packets or both in accordance with a DFR, as appropriate, for transmission by the first or second LIS interface 410 and 420.

[0202] Generation, Activation and Deletion of Data Forwarding Rules

[0203] In some embodiments, Data Forwarding Rules may be predetermined, for example, an apparatus may be preconfigured with one or more predetermined Data Forwarding Rules. According to another embodiment, Data Forwarding Rules may be generated by a user. In some embodiments, Data Forwarding Rules may be generated in response to receiving data packets from the apparatus or from a different apparatus. In some embodiments, the Data Forwarding Rules are generated on the instrument itself. In some embodiments, the Data Forwarding Rules may be generated remotely. In some embodiments, the Data Forwarding Rules may be generated remotely and a Data Forwarding Rule related to a first LIS Environment may only be created by instructions from that first LIS Environment. In some embodiments, the Data Forwarding Rules may be generated remotely and a Data Forwarding Rule related to a first LIS Environment may be created by instructions from any LIS Environment. In some embodiments, the Data Forwarding Rules may be generated remotely and a Data Forwarding Rule related to a first LIS Environment may be created by instructions from any white list LIS Environment. In some embodiments, the Data Forwarding Rules may be generated remotely and a Data Forwarding Rule related to a first LIS Environment may not be created by instructions from any black list LIS Environment.

[0204] In some embodiments, a Data Forwarding Rule may be generated upon receipt of a corresponding request message. The request message can be encoded in one or more data packets.

[0205] In some embodiments, a DFR includes a DFR initiation date, z.e., a date after which the DFR is applied. In some embodiments, a DFR includes a DFR expiry date, z.e., a date after which the DFR is no longer applied.

[0206] In some embodiments, a DFR includes a DFR result exclusion date, z.e., a date after which if no positive results for a particular pathogen have been detected in a certain timeframe or after a certain number of patient sample runs, the DFR is no longer applied. This can be useful when there is an outbreak in a region.

[0207] In some embodiments, a DFR includes a DFR event-based conditions which, if satisfied, cause the DFR to expire.

[0208] In some embodiments, the DFR may be configured to be in effect until one or a combination of two or more predetermined events occur. Example events can include exhaustion of a predetermined number of invocations of a DFR, purging of DFRs in a predetermined manner upon exhaustion of a predetermined maximum number of DFRs, a delete request from a LIS Environment, upon detection of overuse of a Data Forwarding Rule, or a restart of one or more components of a system.

[0209] In some embodiments, Data Forwarding Rules may be generated or deleted collectively or one by one in response to one or more generation or delete events.

[0210] According to embodiments, a predetermined maximum number of Data Forwarding Rules may be in effect. In some embodiments, quotas for Data Forwarding Rules can be in effect, for example, per LIS Environment or per result. Quotas for Data Forwarding Rules may be uniform for all LIS Environments or different for different LIS Environments. Quotas for Data Forwarding Rules may be uniform for all assays or different for different assays.

[0211] Forwarding Data

[0212] In some embodiments, a first data packet received by the LIM including a first Data Packet Identifier can be forwarded according to a Data Forwarding Rule to a first LIS environment. In some embodiments, at least one second outgoing packet is generated which is sent to a second LIS Environment.

[0213] Data forwarding based upon a data forwarding rule and a Data Packet Identifier can be used to discriminate data packets over data forwarding that is based on the data forwarding rule or a Data Packet Identifier alone.

[0214] In some embodiments, one or more of the Data Packet Identifier elements may change as a consequence of the application of the Data Forwarding Rule. As such, in some cases, a Data Packet Identifier may indicate that the result be sent to a first LIS Environment, but after application of the Data Forwarding Rule, the result is only sent to a second LIS Environment.

[0215] Scalability Features

[0216] Scalability may utilize or operate with the data forwarding rules described herein to facilitate increased availability of connections between the apparatus and the first LIS Environment and the second LIS Environment.

[0217] In some embodiments, scalability may involve, when configuring a DFR, specifying a range or set of acceptable second LIS Environments to be associated with outgoing packets, which are configured to go to a first LIS Environment.

[0218] In some embodiments, establishing a DFR includes specifying one or more LIS Environments, wherein one or both of the LIS Environments are acceptable to send the outgoing packet and the apparatus determines which LIS Environment to send the outgoing packet based on volume. Ranges or sets may be explicitly specified by transmitting range endpoints, or implicitly specified by use of wildcards, don't care conditions or bit masking for example. The apparatus may select one or more unused LIS Environments from the range or set, thereby reducing the potential that an outgoing packet will be rejected by the LIS Environment because it is already in use.

[0219] Thus, a DRF may include ranges or sets of acceptable LIS Environments, instead of specifying only a single acceptable LIS Environment.

[0220] In some embodiments, a data packet received from the apparatus is processed by the LIM in accordance with a DFR the Data Packet Identifier or both, and a processed packet (outgoing packet) based thereon is forwarded to the first LIS Environment. In some embodiments, the second LIS Environment may be used as an additional routing dependency for outgoing packets, thereby increasing the number of outgoing packets that can be delivered.

[0221] For example, an outgoing packet destined for the microbiology laboratory may be configured as HL7 and the connection is TCP. The communication protocol and connection method may be modified by DFRs so that the result is delivered to the General Laboratory instead of or in addition to the microbiology laboratory.

[0222] A DFR may be implemented such that outgoing packets, which are destined to be delivered to a first LIS Environment are forwarded to a second LIS Environment. Use of the second LIS Environment as routing dependencies provides an increase in the number of possible routing paths.

[0223] Security Features

[0224] In some embodiments, additional steps are needed before the activation of one or more Data Forwarding Rules to provide a number of security features. For example, steps may be taken during which rights may be negotiated between LIS Environments and an apparatus that determine which Data Forwarding Rules may be activated when and by what LIS Environments. For example, limitations may be imposed on the ability to activate Data Forwarding Rules.

[0225] In some embodiments, restrictions may be predetermined or activated during operation in response to predetermined limit events. Restrictions may, once effected, expire at predetermined deleterestriction events. Limit or delete-restriction events may include one or a combination of two or more of the following examples: expiry of a predetermined lifetime of a Data Forwarding Rule, expiry of a predetermined number of invocations of a Data Forwarding Rule, purging upon exhaustion of a predetermined maximum number of Data Forwarding Rules, a delete request from a LIS Environment, upon detection of abuse of a Data Forwarding Rule, or a restart of one or more components of a system.

[0226] By imposing restrictions on which Data Forwarding Rules may be activated, forwarding of each data-packet can be controlled based upon its identifier.

[0227] In some embodiments, a request for activation of a Data Forwarding Rule may include one or more destination LIS Environments from which the Data Forwarding Rule can be activated.

[0228] In some embodiments, establishing and implementing a DFR may be performed without explicit participation by a first LIS Environment, a second LIS Environment, or both. For example, a DFR may automatically be set up between the apparatus and the first LIS Environment, and the second LIS Environment without requiring special configuration on the part of either.

[0229] FIG. 9 is a block diagram representing an exemplary software architecture and information flow for system 1000, according to some embodiments. FIG. 9 is a reproduction in part of FIG. 63 from US Patent Application Publication US 2018 / 0095100 Al by Nguyen et al. with added detail relating to the templated comments feature. In particular this aspect of Nguyen et al. is incorporated by reference in its entirety. System 1000 may comprise instrument software module (ISW) 1018, bay software module 1020, and an assay analysis module (AAM) 1022. The ISW 1018 may generally reside in an instrument 1002 (not shown) although portions of ISW 1018 may also reside in client device 1006 (not shown). The bay software module 1020 resides in processing bay 440 of an instrument (not shown) although portions or all of software module can also reside in other portions of instrument 1002 (not shown). The AAM module 1022 can reside in one or more of instrument 1002, client device 1006, and server 1008.

[0230] To perform a test, an assay definition file (ADF) 1024 may be received by the ISW 1018. The ADF 1024 may typically be defined by a client device before being transferred to ISW 1018. The ADF 1024 may comprise two portions including an OPUS file and an AAM file. The OPUS file may include parameters that define all operations controlled by the execution of bay software module 1020. The AAM file may include parameters that define analysis performed by AAM module 1022.

[0231] In operation, a sample is loaded into an instrument bay. The bay module 1020 may obtain scan data and log data, which are sent to the ISW. The ISW sends the scan data to the AAM module. The AAM module may generate a test result as a result of the AAM file parameters being applied to the scan data. The test result is reported to the ISW. The ISW may apply the DFR via the LIM module 1023. In some embodiments, the LIM 1023 is located in the AAM module 1022. In some embodiments, the LIM 1023 is located after the AAM module 1022. A configured result may be generated by the ISW. The configured result is reported to the AAM module. The AAM module sends the configured report (outgoing data packet) 1024 to the hospital LIS with the correct formatting to be received by the hospital LIS.

[0232] FIG. 5 is a flowchart representation of an exemplary process 1028 performed by system 100 to analyze a sample, according to some embodiments. The steps of process 1028 concern software operations that may be concurrent with the sample preparation and sample reaction processes that are described with respect to FIGS. 16-23 (sample preparation) and FIG. 60 (sample reaction) of U.S Publication no. 2018-0095100 which is herein incorporated by reference in its entirety. In preferred embodiments, sample preparation precedes sample reaction. As described with respect to FIG. 16 of U.S Publication no. 2018-0095100, a fluid sample specimen may be dispensed into sample well 78. After sample well 78 is closed the cartridge 10 is placed into the processing bay 440 of instrument 1002. The steps of process 1028 can begin just prior to or after the receipt of cartridge 10 into processing bay 440. According to step 1030, ISW 1018 may receive ADF file 1024 (FIG. 9 of this application). According to step 1030.1 the ISW 1018 may receive a Pending Test Order (PTO). According to step 1030.2 the ISW 1018 may receive an assay type from the assay cartridge. According to step 1032, ISW 1018 may send an OPUS portion of ADF file 1024 to the processing bay module 1020. The OPUS portion of the ADF file 1024 may comprise first parameters controlling the sample preparation module 70 and second parameters controlling the sample reaction module 240 (see FIG. 61 of U.S Publication no. 2018-0095100).

[0233] According to step 1034 the first parameters may be applied to the sample preparation module to process the fluid sample specimen so that it is ready for the reaction module. According to step 1036, the second parameters may be applied to the sample reaction module to further process the fluid sample specimen and to generate scan data from sensors in the reaction module. According to step 1038 the sensor scan data may be transferred from the processing bay module 1020 to the ISW 1018. Also as part of step 1038, log data that can include sensing conditions and other data may be transferred from processing bay module 1020 to ISW 1018.

[0234] According to step 1040 the scan data and AAM file parameters that are part of the ADF file 1024 may be transferred to or define the AAM module. In some embodiments, AAM module may already have the AAM file parameters that are part of the ADF file 1024, and thus no transfer is necessary. According to step 1042, the AAM module may generate a test result as a result of the AAM file parameters being applied to the scan data. According to step 1044, a report may be generated that reports the test result from step 1042. As discussed herein , the process of generating a report in step 1044 may include generating a configured report which has been customized to be delivered to a specific LIS Environment. The report is customized by use of a LIM which can apply DFRs and / or Data Packet Identifiers to generate an outgoing data packet. The customized outgoing data packet is sent to the LIS environment 1045.

[0235] In some embodiments, the detection results are configured according to Fig. 8. As shown in FIG. 8 each detection result (message format) is customized with its own settings such as a communication protocol, connection method, relevant information, and result formatting. In Fig. 8, the customization settings are shown in a particular flow, i.e., for GenLab, a communication protocol is selected, then the connection method etc. In some embodiments, a specific order of customization settings is followed, i.e., a communication protocol is selected, then a connection method, then relevant information, and then result formatting. In some embodiments, the order of customization settings is changed from the just described order: such as selecting a connection method, then a communication protocol is selected, then relevant information, and then result formatting. In some embodiments, the order of customization settings is changed from the just described order and the order of selection of the selection parameters (connection method, communication protocol, relevant information, and result formatting) is irrelevant.

[0236] In some embodiments, every selection parameters (connection method, communication protocol, relevant information, and result formatting) must be selected before the detection result can be reported. In some embodiments, a plurality of selection parameters must be selected before the detection result can be reported. In some embodiments, at least one selection parameter must be selected before the detection result can be reported. In some embodiments, at least two selection parameters must be selected before the detection result can be reported. In some embodiments, at least three selection parameters must be selected before the detection result can be reported. In some embodiments, no selection parameters must be selected before the detection result can be reported.

[0237] EXAMPLES

[0238] Example 1

[0239] In some embodiments, in order to activate a DFR within the apparatus, the LIS Environment sends a message requesting DFR activation. The message includes instructions on how to format data packet information into a LIS Environment Information Packet.

[0240] The apparatus determines if the DFR request is feasible. If so, the apparatus grants and activates the corresponding DFR. The apparatus sends a confirmation message to the LIS Environment that requested the DFR specifying that the DFR request has been granted. In some embodiments, the apparatus sends a confirmation message to the LIS Environment that requested the DFR and to another LIS Environment specifying that the DFR request has been granted. In some embodiments, the apparatus sends a confirmation message to an LIS Environment that did not request the DFR specifying that the DFR request has been granted.

[0241] The information included in the confirmation includes at least the LIS Environment Information Packet information. The confirmation may also include, for example, information about how long the DFR will be active in the apparatus. In some embodiments, a LIS Environment can request another DFR while response message is still outstanding. Alternatively, the apparatus refuses the second DFR request while the response message is still outstanding and notifies the LIS Environment accordingly.

[0242] Subsequently, if the DFR has been activated, the apparatus sends a message indicating that a DFR has been established for direct communication between the apparatus and the LIS Environment. The apparatus can subsequently submit outgoing data packets directly to the LIS Environment that include an identifier that complies with the identifier encoded in the DFR just activated for as long as the corresponding DFR remains active. If the DFR has been rejected (not illustrated), LIS Environment may submit another DFR request requesting activation of the same or a different DFR. The apparatus may be configured to process none or up to a predetermined maximum number of DFR requests from the same LIS Environment.

[0243] Example 2

[0244] In some embodiments, the apparatus can be configured to provide further security functions by requiring the apparatus to authenticate with the LIS Environment before being able to set up a DRF rule. With this added level of security, the DFR mechanism can become more resilient against a number malware attacks. Optionally, apparatus can aid in security by not allowing any local traffic between the LIS Environments which prevents an infected LIS Environment from infecting the others.

[0245] It will be appreciated that, although specific embodiments have been described herein for purposes of illustration, various modifications may be made without departing from the spirit and scope of the disclosure. In particular, it is within the scope of the disclosure to provide a computer program product or program element, or a program storage or memory device such as a solid or fluid transmission medium, magnetic or optical wire, tape or disc, or the like, for storing signals readable by a machine, for controlling the operation of a computer according to the methods disclosed herein and / or to structure its components in accordance with the system disclosed herein.

[0246] Further, each step of the method may be executed on any general computer, such as a personal computer, server or the like and pursuant to one or more, or a part of one or more, program elements, modules or objects generated from any programming language, such as C++, Java, PL / 1, or the like. In addition, each step, or a file or object or the like implementing each said step, may be executed by special purpose hardware or a circuit module designed for that purpose.

[0247] It is obvious that the foregoing embodiments of the system are examples and can be varied in many ways. Such present or future variations are not to be regarded as a departure from the spirit and scope of the disclosure, and all such modifications as would be obvious to one skilled in the art are intended to be included within the scope of the following claims.

Claims

CLAIMS1. A method for reporting detection results, the method comprising:- generating by a diagnostic instrument a first detection result;- formatting the first detection result by the diagnostic instrument into a first format;- formatting the first detection result by the diagnostic instrument into a second format wherein the first format and the second format specify different communication protocols, connection methods, result formatting and / or combinations thereof;- reporting the first detection result in the first format to a first Laboratory Information System (LIS) environment interface operatively coupled to a first LIS environment; and- reporting the first detection result in the second format to a second LIS environment interface operatively coupled to a second LIS environment.

2. A method for reporting detection results, the method comprising:- generating by a diagnostic instrument a first detection result;- formatting the first detection result by the diagnostic instrument into a first format;- reporting the first detection result in the first format to a first LIS environment interface operatively coupled to a first LIS environment; and- reporting the first detection result in the first format to a second LIS environment interface operatively coupled to a second LIS environment wherein the first LIS environment interface and the second LIS environment interface have the same or different communication protocols, connection methods, result formatting and / or combinations thereof.

3. A method for reporting detection results, the method comprising:- generating by a diagnostic instrument a first detection result;- formatting the first detection result by the diagnostic instrument into a first format;- formatting the first detection result by the diagnostic instrument into a second format wherein the first format and the second format specify different communication protocols, connection methods, result formatting and / or combinations thereof;- reporting the first detection result in the first format to a first LIS environment interface and to a second LIS environment interface wherein the first LIS environment interface and the second LIS environment interface have different communication protocols, connection methods, result formatting and / or combinations thereof; and- reporting the first detection result in the second format to a third LIS environment interface wherein the first LIS environment interface, the second LIS environmentinterface, and the third LIS environment interface have different communication protocols, connection methods, result formatting and / or combinations thereof.

4. The method of any one of claims 1 to 3, wherein formatting comprises defining a communication protocol, defining a connection method, defining relevant information, formatting results, and / or any combinations thereof for a specified LIS environment.

5. The method of claim 4, wherein the communication protocol is ASTM or HL7 and / or wherein the connection method is TCP / IP or Serial.

6. The method of any one of claims 1 to 3, wherein reporting the first detection result only occurs if the first format matches the first LIS environment requirements, wherein the LIS environment requirements comprise or consist of a communication protocol, defining a connection method, formatting results, and / or combinations thereof.

7. The method of any one of claims 1 to 6, wherein the first detection result is a respiratory result and the respiratory result is reported via molecular and microbiology formatting.

8. The method of any one of claims 1 to 7, wherein only detection results with a defined format are reported to a specified LIS environment interface.

9. The method of any one of claims 1 to 8 further comprising receiving by the diagnostic instrument a first pending test order from the first LIS environment in a first pending test order format.

10. The method of any one of claims 1 to 9, wherein formatting the first detection result by the diagnostic instrument comprises sending by a pathogen detector the first detection result to a LIS Interchange Manager (LIM).

11. The method of claim 10 further comprising applying by the LIM a data forwarding rule (DFR) from a DFR database based on a first detection result identifier.

12. The method of claim 11, further comprising:- configuring by the LIM the first detection result to form a first configured detection result; and- sending by the LIM the first configured detection result to a first LIS environment interface based on the data forwarding rule.

13. The method of claim 11 further comprising determining by the LIM if a second DFR from the DFR database applies based on the first detection result identifier.

14. The method of claim 13 further comprising:- configuring by the LIM the first detection result to form a second configured detection result; and- sending by the LIM the second configured detection result to the second LIS environmentinterface based on the second data forwarding rule.

15. The method of any one of claims 1 to 14, wherein formatting the first detection result by the diagnostic instrument into a first format comprises reconfiguring by the detection instrument the first detection result into a first outgoing data packet.

16. The method of any one of claims 1 to 15, wherein formatting the first detection result by the diagnostic instrument into a first format comprises reconfiguring by the detection instrument the first detection result into a first outgoing data packet based on the DFRs and / or data packet identifiers to generate a first outgoing data packet.

17. The method of any one of claims 1 to 16 further comprising reconfiguring by the detection instrument the first detection result into a second outgoing data packet, delivering by the detection instrument the second outgoing data packet to the second LIS environment interface.

18. The method of any one of claims 1 to 17, wherein the first detection result comprises a data packet identifier associated with the first LIS environment interface.

19. A method for managing data forwarding rules (DFR) on a detection instrument the method comprising:- displaying by the detection instrument a system setup interface; and- receiving by the detection instrument a user section of one of create a new DFR, manage a DFR, delete a DFR, view a DFR or enable / disable a DFR.

20. The method of claim 19, further comprising, in response to the user selection of create the new DFR, displaying by the detection instrument all possible targets; in response to the user selection of a selected target, displaying by the detection instrument possible results formatting for the selected target; in response to the user selection of a selected results formatting, creating by the detection instrument the new DFR.

21. The method of any one of claims 19 to 20 further comprising receiving by the conflict detection and resolution module user selection between the existing DFR or the new DFR.

22. The method of any one of claims 19 to 21 further comprising persisting the new DFR within the DFR database.

23. The method of any one of claims 19 to 22 further comprising, in response to the user selection of manage the DFR, displaying by the detection instrument installed assay data forwarding rule dropdown which contains installed assays on the detection instrument; in response to receiving by the detection instrument user selection of the installed assay, displaying by the detection instrument a drop-down menu which contains the DFRs that have been set up on the detection instrument for a selected assay; receiving by the detectioninstrument the user selection of the DFR; receiving by the detection instrument a user modification of a first DFR to create a modified DFR; and sending by the detection instrument confirmation of the modified DFR to the LIS and / or LIM.

24. The method of any one of claims 19 to 23 further comprising, in response to the user selection of delete the DFR, displaying by the detection instrument all of the installed assays on the detection instrument; receiving by the detection instrument user selection of the installed assay; displaying by the detection instrument a drop-down menu which contains the DFRs that have been set up on the detection instrument for the selected assay; receiving by the detection instrument the user selection of the DFR and instructions to delete a selected DFR; and sending by the detection instrument confirmation of the deleted DFR to the LIS and / or LIM.

25. The method of any one of claims 19 to 24 further comprising, in response to the user selection of view the DFR, displaying by the detection instrument all of the installed assays on the detection instrument; receiving by the detection instrument user selection of the installed assay; displaying by the detection instrument a drop-down menu which contains the DFRs that have been set up on the detection instrument for the selected assay; receiving by the detection instrument the user selection of the DFR and displaying by the detection instrument the selected DFR.

26. The method of any one of claims 19 to 25, further comprising in response to the user selection of enable / disable the DFR, displaying by the detection instrument all of the installed assays on the detection instrument; receiving by the detection instrument user selection of an installed assay; displaying by the detection instrument a drop-down menu which contains the DFRs that have been set up on the detection instrument for the selected assay; receiving by the detection instrument the user selection of the DFR and instructions to enable / disable the selected DFR; and sending by the detection instrument confirmation of the deleted DFR to the LIS and / or LIM.

27. The method of any one of claims 19 to 20 further comprising:- receiving by a detection instrument the new DFR;- merging by a conflict detection and resolution module on the detection instrument the new DFR with existing DFRs stored on the detection instrument; and- detecting by the conflict detection and resolution module any conflicts resulting from a merge operation.

28. The method of claim 27 further comprising resolving by the conflict detection and resolution module any detected conflict between the new DFR and existing DRFs stored on thedetection instrument using a set of conflict resolution rules stored on the detection instrument.

29. The method of any one of claims 19 to 28 further comprising:- receiving a patient sample by the detection instrument;- processing the patient sample by the detection instrument; and- reporting the patient sample by the detection instrument based on the new DFR, the modified DFR, the deleted DFR, and / or the enabled / disabled DFR.

30. A method for reporting detection results, the method comprising:- generating a first data pack by a detection instrument;- reconfiguring by the detection instrument the first data pack, wherein reconfiguring comprises applying by the detection instrument DFRs and / or data packet identifiers to generate a first outgoing data packet; and- sending by the detection instrument the first outgoing data packet to the first LIS environment interface.

31. The method of claim 30, wherein the diagnostic instrument has more than one communication protocol with the first LIS environment.

32. The method of claim 31, wherein the communication protocol is ASTM or HL7.

33. The method of any one of claims 30 to 32, wherein the diagnostic instrument has more than one connection method with the first LIS environment.

34. The method of claim 33, wherein the connection method with the first LIS environment is TCP / IP or Serial.

35. The method of any one of claims 30 to 34, wherein the diagnostic instrument is configured to send detection results in more than one format to the first LIS environment.

36. The method of any one of claims 30 to 35, wherein the diagnostic instrument is configured to send detection results in more than one format to more than one LIS environment.

37. The method of any one of claims 30 to 36, wherein the diagnostic instrument further comprises a data forwarding rule database.

38. The method of any one of claims 36 to 37, wherein the first LIS environment and the second LIS environment have different communication protocols, connection methods, result formatting and / or combinations thereof.

39. The method of any one of claims 30 to 38, wherein generating a first outgoing data packet comprises selecting a communication protocol, connection method, result formatting and / or combinations thereof.

40. The method of any of claims 30 to 39, wherein the diagnostic instrument is configured toformat data to be sent to a first LIS environment and a second LIS environment comprising:- generating a first outgoing data packet based on a first data packet identifier for the first LIS environment;- generating a second outgoing data packet based on a second data packet identifier for the second LIS environment; and- delivering the first outgoing data packet to the first LIS environment, and delivering the second outgoing data packet to the second LIS environment, wherein the first outgoing data pack and second outgoing data pack are different and wherein the first LIS environment and the second LIS environment are different.

41. The method of claim 40, wherein generating the second outgoing data packet comprises selecting a communication protocol, connection method, result formatting and / or combinations thereof.

42. The method of claim 37, wherein the LIM comprises the data forwarding rule database.

43. The method of any one of claims 30 to 42, wherein the diagnostic instrument comprises a data forwarding rule configuration interface.

44. The method of any one of claims 30 to 43, wherein the diagnostic instrument comprises a data forwarding rule import module.

45. The method of any one of claims 30 to 44, wherein the diagnostic instrument comprises a data forwarding rule conflict resolution module.

46. The method of any one of claims 30 to 45, wherein the diagnostic instrument comprises more than one connection to a LIS environment.

47. The method of claim 46, wherein the diagnostic instrument comprises 2-5 connections to a LIS environment.

48. The method of any one of claims 30 to 47, wherein reconfiguring the first data pack comprises checking if a data forwarding rule in the data forwarding rule database applies.

49. The method of any one of claims 30 to 48, wherein reconfiguring the first data pack comprises formatting the first detection result based on a first data forwarding rule in the data forwarding rule database.

50. The method of any one of claims 30 to 49, wherein reconfiguring the first data pack comprises formatting the detection result of the first data pack to go to a second LIS environment.

51. The method of any one of claims 30 to 50, wherein reconfiguring the first data pack comprises selecting a communication protocol, connection type, and / or result formatting.

52. The method of any one of claims 30 to 51, wherein reconfiguring the first data packcomprises checking if a data packet identifier exists.

53. The method of any one of claims 30 to 52, wherein reconfiguring the first data pack comprises checking if a data forwarding rule applies.

54. A diagnostic instrument comprising a Laboratory Information System Interchange Manager (LIM) and a first LIS environment interface operatively coupled to a first LIS environment.

55. The diagnostic instrument of claim 54, wherein the diagnostic instrument generates a first detection result and configures the first detection result by the LIM to generate a first configured detection result and the detection instrument is configured to report the first configured detection result to a first LIS environment.

56. The diagnostic instrument of any one of claims 54 to 55, wherein the diagnostic instrument has more than one communication protocol with the first LIS environment.

57. The diagnostic instrument of claim 56, wherein the communication protocol is ASTM or HL7.

58. The diagnostic instrument of any one of claims 54 to 57, wherein the diagnostic instrument has more than one connection method with the first LIS environment.

59. The diagnostic instrument of claim 58, wherein the connection method with the first LIS environment is TCP / IP or Serial.

60. The diagnostic instrument of any one of claims 54 to 59, wherein the diagnostic instrument is configured to send detection results in more than one format to the first LIS environment.

61. The diagnostic instrument of any one of claims 54 to 60, wherein the diagnostic instrument is configured to send detection results in more than one format to more than one LIS environment.

62. The diagnostic instrument of any one of claims 54 to 61, wherein the diagnostic instrument further comprises a data forwarding rule database.

63. The diagnostic instrument of any one of claims 54 to 62, wherein the first LIS environment and the second LIS environment have different communication protocols, connection methods, result formatting and / or combinations thereof.

64. The diagnostic instrument of any one of claims 54 to 63, wherein generating the first configured detection result comprises selecting a communication protocol, connection method, result formatting and / or combinations thereof.

65. The diagnostic instrument of any of claims 54 to 64, wherein the diagnostic instrument is configured to format data to be sent to a first LIS environment and a second LIS environment comprising:- generating a first configured detection result based on a first data packet identifier for thefirst LIS environment;- generating a second configured detection result based on a second data packet identifier for the second LIS environment; and- delivering the first configured detection result to the first LIS environment, and delivering the second configured detection result to the second LIS environment, wherein the first configured detection result and second configured detection result are different and wherein the first LIS environment and the second LIS environment are different.

66. The diagnostic instrument of any one of claims 54 to 65, wherein configuring the first detection result comprises checking if a data forwarding rule in the data forwarding rule database applies.

67. The diagnostic instrument of any one of claims 55 to 66, wherein configuring the first detection result comprises formatting the first detection result based on a first data forwarding rule in the data forwarding rule database.

68. The diagnostic instrument of any one of claims 55 to 67, wherein configuring the first detection result comprises formatting the first detection result to go to a second LIS environment.

69. The diagnostic instrument of any one of claims 55 to 68, wherein configuring the first detection result comprises selecting a communication protocol, connection type, and / or result formatting.

70. The diagnostic instrument of any one of claims 55 to 69, wherein the diagnostic instrument is configured to generate an outgoing data packet based on the first configured detection result.

71. The diagnostic instrument of any one of claims 55 to 70, wherein configuring the first detection result comprises checking if a data packet identifier exists.

72. The diagnostic instrument of any one of claims 55 to 71, wherein configuring the first detection result comprises checking if a data forwarding rule applies.

73. The diagnostic instrument of any one of claims 55 to 72 further comprising reporting by the diagnostic instrument the first configured detection result based on the data forwarding rule and / or data packet identifier.

74. A system comprising a diagnostic instrument comprising a Laboratory Information System Interchange Manager (LIM) according to any one of claims 54 to 73 configured to make multiple connections to a first LIS environment.

75. A diagnostic instrument with at least a first Laboratory Information System (LIS)environment interface, a second LIS environment interface, a pathogen detector circuit, a pathogen reporting circuit, a LIS Interchange Manager (LIM), a data forwarding rule (DFR) database, and a graphical user interface (GUI), the GUI comprising a DFR configuration interface.

76. The diagnostic instrument of claim 75, wherein the DFR configuration interface comprises a first GUI interface comprising (1) the schedule of installed assay panels, (2) the schedule of installed DFRs, (3) a list of specialized DFRs that are unique to the detection instrument, the laboratory, a hospital or geographic region of the laboratory / hospital, (4) DFR recommendations which are DFRs recommended for the detection instrument, the laboratory, the hospital or geographic region of the laboratory / hospital, (5) DFR conflict resolution manager, (6) DFR manager, (7) DFR customization module, (8) DFR notification module, (9) DFR import module, and / or (10) combinations thereof.

77. The diagnostic instrument of any one of claims 75 to 76, wherein the DFR recommendations are configured to be checked on or off from a drop-down menu.

78. The diagnostic instrument of any one of claims 75 to 77, wherein the DFR database stores DFRs.

79. The diagnostic instrument of claim 78, wherein the DFR import module is configured to manage the importation of DFRs from local and / or remote databases to the diagnostic instrument.

80. The diagnostic instrument of any one of claims 76 to 79, wherein the DFR import module comprises the DFR conflict resolution manager.

81. The diagnostic instrument of any one of claims 75 to 80, wherein the first LIS environment interface is operatively coupled to a first LIS environment and the second LIS environment interface is operatively coupled to a second LIS environment and the first LIS environment interface and the second LIS environment interface have different communication protocols, connection methods, result formatting and / or combinations thereof.

82. The diagnostic instrument of any one of claims 75 to 81, wherein the first LIS environment interface comprises a plurality of connections to a first LIS environment.

83. The diagnostic instrument of any one of claims 75 to 82, wherein the second LIS environment interface comprises a plurality of connections to a second LIS environment.

84. The diagnostic instrument of any one of claims 75 to 83, further comprising a data packet processing system operatively coupled to the first LIS environment interface.

85. The diagnostic instrument of any one of claims 75 to 84, wherein the DFR configuration interface is configured to:- receive the user selection to create a data forwarding rule;- receive the user selection to manage a data forwarding rule;- receive the user selection to delete a data forwarding rule;- receive the user selection to view a data forwarding rule;- receive the user selection to enable a data forwarding rule; and / or- receive the user selection to disable a data forwarding rule.

86. The diagnostic instrument any one of claims 75 to 85, comprising a memory, the memory comprising the pathogen detector, the LIM, and the data forwarding rule database.

87. The diagnostic instrument any one of claims 75 to 86, wherein the first connection to the first LIS environment interface and second connection to the first LIS environment interface have different communication protocols, connection methods, result formatting and / or combinations thereof.

88. The diagnostic instrument of any one of claims 75 to 87, comprising a third connection to the second LIS environment interface wherein the first and third connections have different communication protocols, connection methods, result formatting and / or combinations thereof and the first LIS environment interface and the second LIS environment interface have different communication protocols, connection methods, result formatting and / or combinations thereof.

89. The diagnostic instrument of any one of claims 75 to 88, wherein the diagnostic instrument comprises 2, 3, 4, 5, or 6 LIS environment interfaces.

90. The diagnostic instrument of claim 89 wherein each LIS environment interface is operatively coupled to a unique LIS environment.

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