LIMS and laboratory informatics questionnaire/1.5 System-specific

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 Laboratory information system 1.5a.1 Regulatory compliance Request for information Requirement code Vendor response 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? 1.5a.2 General functions Request for information Requirement code Vendor response a. Does your system include clinical trial management tools? If so, elaborate. b. Does your system provide patient case management and assignment? c. Does your system provide physician, clinic, and contract lab management tools? d. Does your system provide outreach and call list management tools? e. Does your system provide multi-site, multi-lab, or multi-physician group management tools? f. Does your system provide disease tracking functionality? g. Does your system monitor turnaround time, from test request to clinician review? h. Is your system veterinary compatible? 1.5a.3 Configuration and customization Request for information Requirement code Vendor response 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? b. Does your system provide flexible and customizable mapping dictionaries for interconversion of different standards and more? c. Does your system support customizable test, panel, and profile libraries? d. Does your system support provisions for correctional facilities? e. Does your system support customization of test pick lists based on specialty utilization? 1.5a.4 Receiving and scheduling Request for information Requirement code Vendor response a. Does your system allow users to create, manage, and track viewable sample container schemata? 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.? c. Does your system automatically split and manage orders requiring multiple testing locations? d. Does your system create and manage administrative documents for genetics testing? e. Does your system allow standing orders and test schedules to be defined for future orders? f. Can your system import and utilize the Centers for Medicare and Medicaid Services' (CMS') National and Local Coverage Determinations files? g. Does your system track and manage advance beneficiary notices (ABNs) from CMS as needed? h. Can your system differentiate "investigation use only" and "research use only" tests? 1.5a.5 Analysis and data entry Request for information Requirement code Vendor response a. Does your system effectively manage complex molecular protocols? Explain. b. Does your system effectively manage genetic testing protocols? Explain. c. Does your system effectively manage histology and cytology protocols? Explain. d. Does your system allow for user-definable and procedure-specific protocols for HIV specimens? Explain. e. Does your system effectively manage biobanking and blood banking activities and the data associated with them? Explain. 1.5a.6 Post-analysis and validation Request for information Requirement code Vendor response a. Does your system include data mining tools for model learning, evaluation, and usage? b. Does your system report molecular results in both clinical and anatomical pathology environments? c. Does your system provide tools for graphical patient and analyte trend plotting? 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? 1.5a.7 External system interfaces Request for information Requirement code Vendor response a. Can your system interface with a hospital information system? b. Can your system interface with an electronic medical record or electronic health record system? 1.5a.8 Reporting Request for information Requirement code Vendor response a. Does your system include a synoptic reporting module? b. Does your system produce specialized reports for microbiology, hematology, assay trend, and/or cardiac risk? c. Does your system produce epidemiology and antibiogram reports? 1.5a.9 Laboratory management Request for information Requirement code Vendor response a. Does your system include revenue management functionality, including medical necessity checks and profitability analysis? 1.5a.10 Custom requirements Request for information Requirement code Vendor response a. b. c. d. e. f. 1.5b Electronic laboratory notebook 1.5b.1 General functions Request for information Requirement code Vendor response a. Does your system allow bookmarking of pages, images, experiments, and other content? b. Does your system provide the option of a double signature scheme for the purpose of patent protection? c. Does your system allow for advanced queries of molecular patterns and properties, like those associated with the SMARTS language? d. Does your system provide multi-lab management tools? e. Does your system integrate chemical drawing and computational tools? f. Does your system allow the import of chemical structure and spectroscopic files? g. Does your system permit users to query by functional group or designed structure? h. Can your system process text-to-structure conversions automatically? i. Can your system include a synthesis sheet parser and generator? j. Does your system provide a built-in instant messaging system for experiment and project collaborators? k. Does your system provide a searchable repository for user notebooks present and past? 1.5b.2 Configuration and customization Request for information Requirement code Vendor response a. Does your system permit users to create personal and sharable experiment templates? 1.5b.3 Pre-experiment Request for information Requirement code Vendor response a. Does your system provide compound and batch registration? b. Does your system allow editing of biological sequences at the molecular level? c. Does your system provide extensive experiment management tools to create, manage, and run single-step, multi-step, and other types of experiments? d. Does your system allow the creation of searchable image annotations? e. Does your system provide tools for making advanced chemical calculations, including stoichiometric, titration, and reaction yield calculations? 1.5b.4 Post-experiment Request for information Requirement code Vendor response a. Does your system allow users to comment on experiment results, observations, and conjectures as well as allow for linking to and from comments? b. Does your system allow users to create project Gantt charts? c. Does your system capture and store an encrypted PDF (or other document format) of a completed page? d. Does your system capture and store images from image analysis? 1.5b.5 External system interfaces Request for information Requirement code Vendor response a. Can your system interface with third-party chemical drawing tools like ChemDraw, MarvinSketch, and Ketcher? b. Can your system interface with chemistry databases, compound management systems, and substance logistics systems? c. Can your system interface with other laboratory information management systems? 1.5b.6 Reporting Request for information Requirement code Vendor response a. Can your system automatically generate experiment reports at specified points in the experimental process? 1.5b.7 Custom requirements Request for information Requirement code Vendor response a. b. c. d. e. f. 1.5c Chromatography and scientific data management system 1.5c.1 Chromatography and scientific data management system - Custom requirements Request for information Requirement code Vendor response a. b. c. d. e. f. g. h.