This addendum to the primary system questionnaire covers system-specific laboratory requirements not common to the laboratory information management system.
NOTE: This addendum is meant to represent additional user requirement specs unique to the system and not represented in the primary system questionnaire.
1.5 System-specific
1.5a.1 Regulatory compliance
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Request for information
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Requirement code
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Vendor response
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a. The system supports AABB (American Association of Blood Banks), College of American Pathologists, (CAP), The Joint Commission (TJC), and/or any additional requirements or standards.
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1.5a.2 General functions
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Requirement code
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Vendor response
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a. The systems includes clinical trial management tools.
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b. The system provides patient case management and assignment.
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c. The system provides physician, clinic, and contract lab management tools.
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d. The system provides outreach and call list management tools.
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e. The system provides multi-site, multi-lab, or multi-physician group management tools.
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f. The system provides disease tracking functionality.
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g. The system monitors turnaround time, from test request to clinician review.
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h. The system is veterinary compatible.
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1.5a.3 Configuration and customization
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Request for information
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Requirement code
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Vendor response
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a. The system permits users to create templates and worksheets for standardizing analysis pages, patient pages, test ordering pages, and/or the reporting processes.
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b. The system provides flexible and customizable mapping dictionaries for interconversion of different standards and more.
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c. The system supports customizable test, panel, and profile libraries.
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d. The system supports provisions for correctional facilities.
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e. The system supports customization of test pick lists based on specialty utilization.
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1.5a.4 Receiving and scheduling
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Request for information
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Requirement code
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Vendor response
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a. The system allows users to create, manage, and track viewable sample container schemata.
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b. The system features order entry rules for better managing duplicate orders, rejecting inappropriate tests, identifying inappropriate containers, rerouting tests to outside labs, etc.
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c. The system automatically splits and manages orders requiring multiple testing locations.
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d. The system creates and manages administrative documents for genetics testing.
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e. The system allows standing orders and test schedules to be defined for future orders.
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f. The system can import and utilize the Centers for Medicare and Medicaid Services' (CMS') National and Local Coverage Determinations files.
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g. The system tracks and manages advance beneficiary notices (ABNs) from CMS as needed.
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h. The system differentiates "investigation use only" and "research use only" tests.
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1.5a.5 Analysis and data entry
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Request for information
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Requirement code
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Vendor response
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a. The system effectively manages histology and cytology protocols.
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b. The system allows for user-definable and procedure-specific protocols for HIV specimens.
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c. The system effectively manages biobanking and blood banking activities and the data associated with them.
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1.5a.6 Post-analysis and validation
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Request for information
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Requirement code
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Vendor response
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a. The system reports molecular results in both clinical and anatomical pathology environments.
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b. The system provides tools for graphical patient and analyte trend plotting.
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c. The system holds all test results on a specimen with multiple tests ordered on it until all work is completed and a final report is issued.
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1.5a.8 Reporting
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Request for information
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Requirement code
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Vendor response
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a. The system produces specialized reports for microbiology, hematology, assay trend, and/or cardiac risk.
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c. The system produces epidemiology and antibiogram reports.
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1.5a.9 Laboratory management
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Request for information
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Requirement code
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Vendor response
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a. The system include revenue management functionality, including medical necessity checks and profitability analysis.
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1.5a.10 Custom requirements
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Request for information
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Requirement code
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Vendor response
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a.
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b.
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c.
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d.
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e.
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f.
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1.5b.1 General functions
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Request for information
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Requirement code
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Vendor response
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a. The system allows bookmarking of pages, images, experiments, and other content.
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b. The system provides the option of a double signature scheme for the purpose of patent protection.
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c. The system allows for advanced queries of molecular patterns and properties, like those associated with the SMARTS language.
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d. The system provides multi-lab management tools.
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e. The system integrates chemical drawing and computational tools.
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f. The system allows the import of chemical structure and spectroscopic files.
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g. The system permits users to query by functional group or designed structure.
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h. The system processes text-to-structure conversions automatically.
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i. The system includes a synthesis sheet parser and generator.
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j. The system provides a built-in instant messaging system for experiment and project collaborators.
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k. The system provides a searchable repository for user notebooks present and past.
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1.5b.2 Configuration and customization
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Request for information
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Requirement code
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Vendor response
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a. The system permits users to create personal and sharable experiment templates.
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1.5b.3 Pre-experiment
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Request for information
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Requirement code
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Vendor response
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a. The system provides compound and batch registration.
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b. The system allows editing of biological sequences at the molecular level.
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c. The system provides extensive experiment management tools to create, manage, and run single-step, multi-step, and other types of experiments.
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d. The system allows the creation of searchable image annotations.
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e. The system provides tools for making advanced chemical calculations, including stoichiometric, titration, and reaction yield calculations.
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1.5b.4 Post-experiment
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Request for information
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Requirement code
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Vendor response
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a. The system allows users to comment on experiment results, observations, and conjectures as well as allow for linking to and from comments.
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b. The system allows users to create project Gantt charts.
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c. The system captures and stores an encrypted PDF (or other document format) of a completed page.
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d. The system captures and stores images from image analysis.
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1.5b.5 External system interfaces
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Request for information
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Requirement code
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Vendor response
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a. The system can interface with third-party chemical drawing tools like ChemDraw, MarvinSketch, and Ketcher.
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b. The system can interface with chemistry databases, compound management systems, and substance logistics systems.
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c. The system interfaces with other laboratory information management systems.
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1.5b.6 Reporting
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Request for information
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Requirement code
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Vendor response
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a. The system automatically generates experiment reports at specified points in the experimental process.
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1.5b.7 Custom requirements
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Request for information
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Requirement code
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Vendor response
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a.
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b.
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c.
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d.
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e.
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f.
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1.5c.1 Chromatography and scientific data management system - Custom requirements
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Request for information
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Requirement code
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Vendor response
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a.
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b.
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c.
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d.
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e.
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f.
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g.
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h.
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