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| ==26. Instrument data systems functions==
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| ! style="color:brown; background-color:#ffffee;"|Requirement and response
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| | style="padding:10px; background-color:white;" |'''26.1''' The system should be able to use an application programming interface or web services to communicate with instrument data systems.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''26.2''' The system should be capable of sending samples and test orders to instrument data systems.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''26.3''' The system should be capable of sending samples and test orders to instrument data systems.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''26.4''' The system should be capable of generically parsing instrument data to extract important sample details and results.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| ==27. Systems integration==
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| ! colspan="1" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
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| ! style="color:brown; background-color:#ffffee;"|Requirement and response
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| | style="padding:10px; background-color:white;" |'''27.1''' The system should be capable of communicating any status changes for samples, lots, instruments, and other dynamic entities to and from external systems.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''27.2''' The system should accurately communicate status changes to external systems.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''27.3''' The system shall provide a means to choose—based on date and type of data—electronic data and metadata to archive.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''27.4''' The system shall provide a guaranteed means to retrieve and restore archived data and metadata that is readable and accurate.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''27.5''' The system should feature a reliable, effective, and supported data storage system.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''27.6''' The system should be able to interface directly with a third-party reporting tool.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''27.7''' The system should be capable of being configured to and conform to the laboratory's existing data storage platforms and standards.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''27.8''' The system should provide the ability to modify the data structures of the data storage mechanism as needed.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''27.9''' The system should allow for both development and production environments for its data storage tools and allow the movement of records from one environment to another.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''27.10''' The system shall provide data storage tools capable of fine-tuning the performance and security of data.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''27.11''' The system’s data storage tools shall provide data backup and retrieval functions that meet or exceed industry best practices, including producing exact and complete backups that are secure from manipulation and loss.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''27.12''' The architecture of the system should be organized such that modules are clearly and logically separated, with standard interfaces provided between the modules.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''27.13''' The system should be able to optimally use system and hardware resources to allow for concurrent usage and high-peak usage.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''27.14''' The system should come with a well-documented application programming interface in order to facilitate granular interfaces with the system's underlying modular functionality.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''27.15''' The system shall provide a means to integrate and exchange data electronically based on relevant methods, and in such a way so as to ensure accurate and secure data transfer and processing.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''27.16''' The system shall be able to accurately replicate its data storage tools to ensure a recoverable system in the event of hardware failure.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''27.17''' The system should be able to interface with an external enterprise resource planning system.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''27.18''' The system should be capable of interfacing with enterprise middleware.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| ==28. Laboratory scheduling and capacity planning==
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| ! style="color:brown; background-color:#ffffee;"|Requirement and response
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| | style="padding:10px; background-color:white;" |'''28.1''' The system should be able to accurately gauge and report test-based work capacity or throughput.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''28.2''' The system should provide scheduling tools for allocating personnel and instruments to laboratory tasks.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''28.3''' The system should provide a means for tasks to be scheduled and allocated against available resources.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''28.4''' The system should be able to track and limit the quantity of samples or hours worked on a type of sample by personnel, e.g., number of cytology slides or hours worked on them.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| ==29. Lean laboratory and continuous improvement==
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| | style="padding:10px; background-color:white;" |'''29.1''' The system should support a workload leveling strategy that automatically releases laboratory tasks to personnel.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''29.2''' The system should provide a means to quickly visualize and assess workflow processes at strategic points.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''29.3''' The system should provide a means for mapping everyday workflow while identifying potential failure points.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| ==30. Artificial intelligence and smart systems==
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| {|
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| | style="padding:10px; background-color:white;" |'''30.1''' The system should provide a means for integrating artificial intelligence (AI) into laboratory workflow as a smart agent or assistant.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''30.2''' The system should support ontology-based machine learning for assisting with the analysis of laboratory informatics datasets.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''30.3''' The system should support voice data capture and retrieval as smart laboratory assistance functions.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''30.4''' The system should be able to reschedule samples, change test assignments, and perform other laboratory activities based on voice command input.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''30.5''' The system should support predictive maintenance routines for laboratory instruments and equipment.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''30.6''' The system should judiciously allow various system parameters to be optimized and ideal models set within the system by AI.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''30.7''' The system should allow AI to algorithmically infer from past learning how to customize without explicit instruction system parameters such as aggregation, transformation, and reporting of data.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''30.8''' The system should monitor laboratory operation parameters (such as capacity utilization and data integrity risks) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored operational parameters and their status changes.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''30.9''' The system should allow for other types of facility monitoring (such as alarm, light, lock, and door statuses) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored systems and their status changes.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''30.10''' The system should monitor instrument health (such as critical parameters and maintenance timing) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored instrument activities and status changes.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''30.11''' The system should allow for environmental control and monitoring of equipment (such as incubators and freezers) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored equipment and their associated status changes.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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