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. 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. 1.5a.2 General functions Request for information Requirement code Vendor response a. The systems includes clinical trial management tools. b. The system provides patient case management and assignment. c. The system provides physician, clinic, and contract lab management tools. d. The system provides outreach and call list management tools. e. The system provides multi-site, multi-lab, or multi-physician group management tools. f. The system provides disease tracking functionality. g. The system monitors turnaround time, from test request to clinician review. h. The system is veterinary compatible. 1.5a.3 Configuration and customization Request for information Requirement code Vendor response a. The system permits users to create templates and worksheets for standardizing analysis pages, patient pages, test ordering pages, and/or the reporting processes. b. The system provides flexible and customizable mapping dictionaries for interconversion of different standards and more. c. The system supports customizable test, panel, and profile libraries. d. The system supports provisions for correctional facilities. e. The system supports customization of test pick lists based on specialty utilization. 1.5a.4 Receiving and scheduling Request for information Requirement code Vendor response a. The system allows users to create, manage, and track viewable sample container schemata. b. The system features order entry rules for better managing duplicate orders, rejecting inappropriate tests, identifying inappropriate containers, rerouting tests to outside labs, etc. c. The system automatically splits and manages orders requiring multiple testing locations. d. The system creates and manages administrative documents for genetics testing. e. The system allows standing orders and test schedules to be defined for future orders. f. The system can import and utilize the Centers for Medicare and Medicaid Services' (CMS') National and Local Coverage Determinations files. g. The system tracks and manages advance beneficiary notices (ABNs) from CMS as needed. h. The system differentiates "investigation use only" and "research use only" tests. 1.5a.5 Analysis and data entry Request for information Requirement code Vendor response a. The system effectively manages histology and cytology protocols. b. The system allows for user-definable and procedure-specific protocols for HIV specimens. c. The system effectively manages biobanking and blood banking activities and the data associated with them. 1.5a.6 Post-analysis and validation Request for information Requirement code Vendor response a. The system reports molecular results in both clinical and anatomical pathology environments. b. The system provides tools for graphical patient and analyte trend plotting. 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. 1.5a.7 External system interfaces Request for information Requirement code Vendor response a. The system can interface with a hospital information system. b. The system can interface with an electronic medical record or electronic health record system. 1.5a.8 Reporting Request for information Requirement code Vendor response a. The system produces specialized reports for microbiology, hematology, assay trend, and/or cardiac risk. c. The system produces epidemiology and antibiogram reports. 1.5a.9 Laboratory management Request for information Requirement code Vendor response a. The 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. The system allows bookmarking of pages, images, experiments, and other content. b. The system provides the option of a double signature scheme for the purpose of patent protection. c. The system allows for advanced queries of molecular patterns and properties, like those associated with the SMARTS language. d. The system provides multi-lab management tools. e. The system integrates chemical drawing and computational tools. f. The system allows the import of chemical structure and spectroscopic files. g. The system permits users to query by functional group or designed structure. h. The system processes text-to-structure conversions automatically. i. The system includes a synthesis sheet parser and generator. j. The system provides a built-in instant messaging system for experiment and project collaborators. k. The system provides a searchable repository for user notebooks present and past. 1.5b.2 Configuration and customization Request for information Requirement code Vendor response a. The system permits users to create personal and sharable experiment templates. 1.5b.3 Pre-experiment Request for information Requirement code Vendor response a. The system provides compound and batch registration. b. The system allows editing of biological sequences at the molecular level. c. The system provides extensive experiment management tools to create, manage, and run single-step, multi-step, and other types of experiments. d. The system allows the creation of searchable image annotations. e. The system provides 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. The system allows users to comment on experiment results, observations, and conjectures as well as allow for linking to and from comments. b. The system allows users to create project Gantt charts. c. The system captures and stores an encrypted PDF (or other document format) of a completed page. d. The system captures and stores images from image analysis. 1.5b.5 External system interfaces Request for information Requirement code Vendor response a. The system can interface with third-party chemical drawing tools like ChemDraw, MarvinSketch, and Ketcher. b. The system can interface with chemistry databases, compound management systems, and substance logistics systems. c. The system interfaces with other laboratory information management systems. 1.5b.6 Reporting Request for information Requirement code Vendor response a. The system automatically generates 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.