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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Requirement code
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Vendor response
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a. Does your system support 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. Does your system include clinical trial management tools? If so, elaborate.
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b. Does your system provide patient case management and assignment?
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c. Does your system provide physician, clinic, and contract lab management tools?
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d. Does your system provide outreach and call list management tools?
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e. Does your system provide multi-site, multi-lab, or multi-physician group management tools?
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f. Does your system provide disease tracking functionality?
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g. Does your system monitor turnaround time, from test request to clinician review?
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h. Is your system veterinary compatible?
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1.5a.3 Configuration and customization
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Requirement code
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Vendor response
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a. Does your system permit 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. Does your system provide flexible and customizable mapping dictionaries for interconversion of different standards and more?
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c. Does your system support customizable test, panel, and profile libraries?
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d. Does your system support provisions for correctional facilities?
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e. Does your system support customization of test pick lists based on specialty utilization?
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1.5a.4 Receiving and scheduling
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Requirement code
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Vendor response
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a. Does your system allow users to create, manage, and track viewable sample container schemata?
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b. Does your system feature 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. Does your system automatically split and manage orders requiring multiple testing locations?
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d. Does your system create and manage administrative documents for genetics testing?
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e. Does your system allow standing orders and test schedules to be defined for future orders?
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f. Can your system import and utilize the Centers for Medicare and Medicaid Services' (CMS') National and Local Coverage Determinations files?
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g. Does your system track and manage advance beneficiary notices (ABNs) from CMS as needed?
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h. Can your system differentiate "investigation use only" and "research use only" tests?
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1.5a.5 Analysis and data entry
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Requirement code
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Vendor response
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a. Does your system effectively manage complex molecular protocols? Explain.
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b. Does your system effectively manage genetic testing protocols? Explain.
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c. Does your system effectively manage histology and cytology protocols? Explain.
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d. Does your system allow for user-definable and procedure-specific protocols for HIV specimens? Explain.
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e. Does your system effectively manage biobanking and blood banking activities and the data associated with them? Explain.
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1.5a.6 Post-analysis and validation
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Requirement code
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Vendor response
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a. Does your system include data mining tools for model learning, evaluation, and usage?
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b. Does your system report molecular results in both clinical and anatomical pathology environments?
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c. Does your system provide tools for graphical patient and analyte trend plotting?
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d. Can your system hold 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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Requirement code
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Vendor response
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a. Does your system include a synoptic reporting module?
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b. Does your system produce specialized reports for microbiology, hematology, assay trend, and/or cardiac risk?
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c. Does your system produce epidemiology and antibiogram reports?
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1.5a.9 Laboratory management
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Requirement code
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Vendor response
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a. Does your 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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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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Requirement code
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Vendor response
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a. Does your system allow bookmarking of pages, images, experiments, and other content?
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b. Does your system provide the option of a double signature scheme for the purpose of patent protection?
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c. Does your system allow for advanced queries of molecular patterns and properties, like those associated with the SMARTS language?
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d. Does your system provide multi-lab management tools?
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e. Does your system integrate chemical drawing and computational tools?
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f. Does your system allow the import of chemical structure and spectroscopic files?
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g. Does your system permit users to query by functional group or designed structure?
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h. Can your system process text-to-structure conversions automatically?
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i. Can your system include a synthesis sheet parser and generator?
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j. Does your system provide a built-in instant messaging system for experiment and project collaborators?
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k. Does your system provide 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. Does your system permit 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. Does your system provide compound and batch registration?
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b. Does your system allow editing of biological sequences at the molecular level?
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c. Does your system provide extensive experiment management tools to create, manage, and run single-step, multi-step, and other types of experiments?
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d. Does your system allow the creation of searchable image annotations?
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e. Does your system provide 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. Does your system allow users to comment on experiment results, observations, and conjectures as well as allow for linking to and from comments?
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b. Does your system allow users to create project Gantt charts?
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c. Does your system capture and store an encrypted PDF (or other document format) of a completed page?
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d. Does your system capture and store 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. Can your system interface with third-party chemical drawing tools like ChemDraw, MarvinSketch, and Ketcher?
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b. Can your system interface with chemistry databases, compound management systems, and substance logistics systems?
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c. Can your system interface 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. Can your system automatically generate 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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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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g.
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h.
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