User:Shawndouglas/Sandbox

1.0 Vendor information

1.0 Vendor information Company name Physical address Website LIMSwiki web page Contact name and title Contact e-mail Contact phone and fax Years in business

1.1 Vendor services

1.1 Vendor services Request for information Requirement code Vendor response a. The vendor offers an online and/or on-site demonstration. b. The vendor provides a detailed project plan that includes the project team, timeline, deliverables, and risk and issue management procedures. c. The vendor explains their overall project approach, deliverables, time constraints, and any other criteria for the project. d. The vendor provides reliable cost estimates and pricing schedules, including all products and services in the scope of work. e. The vendor details the amount of time and staff that the purchaser will have to provide for the implementation process. f. The vendor can explain the maintenance and support offered during and after implementation, including times and methods of availability, issue escalation and management, etc. g. The vendor provides a support schedule for the implementation process, including optional support levels, their function, and availability. h. The vendor provides support during the "go-live" period between system validation/operational deployment and final acceptance/beginning of maintenance and support agreements. i. The vendor provides a gap analysis after initial system installation, identifying the deliverables or tasks remaining. j. The vendor provides a table linking each deliverable to the corresponding user requirement specification it fulfills. k. The vendor uses a consistent training methodology for educating new users. l. The vendor supplies LIS-specific training program curricula. m. The vendor provides user, administrator, developer, installation, and reference manuals. n. The vendor provides design qualification documentation. o. The vendor provides installation qualification documentation. p. The vendor provides operation qualification documentation. q. The vendor provides performance qualification documentation during implementation. r. The vendor provides well-documented system upgrades that authorized users can independently install. s. The vendor provides source code for the system. t. The vendor provides an optional comprehensive set of test codes suitable for use by the purchaser.

1.2 Information technology

1.2.1 General IT 1.2.1 General IT Request for information Requirement code Vendor response a. The system operates with a traditional client-server architecture, with software installed on each machine that needs to access the system. b. The system operates with a web-based interface, hosted on a server and accessed via a web browser on most any machine. c. The system contains a single, centralized database that supports multiple sites and departments. d. The system's database conforms to the Open Database Connectivity Standard (ODBC). e. The system is designed so upgrades to the back-end database do not require extensive reconfiguration or effectively cripple the system. f. The system is designed to not be impacted by multiple users or failover processes. g. The system applies security features to all system files. h. The system applies log-in security to all servers and workstations accessing it. i. The system provides a workstation and server authentication mechanism. j. The system applies Secured Socket Layer (SSL) encryption on the web client interface. k. The system encrypts client passwords in a database, with support for multi-case and special characters. l. The system uses TCP/IP as its network transport. m. The system provides data archiving functionality, including a configurable scheduled archive, for all contained data, without requiring an off-line mode or human interaction with the data to be archived. n. The system allows automated backup and restore capability without support intervention, as well as manual backups. o. The system maintains the transactional history of system administrators. p. The system maintains an analyst communication log, accessible by the administrator. 1.2.2 Hardware environment 1.2.2 Hardware environment Request for information Requirement code Vendor response a. The system proves compatible with a variety of hardware environments. b. The system can be utilized with a touch-screen. 1.2.3 Software environment 1.2.3 Software environment Request for information Requirement code Vendor response a. The system proves compatible with a variety of software environments. b. The system utilizes a non-proprietary database such as Oracle or Microsoft SQL Server.

1.3 Regulatory compliance and security

1.3.1 Regulatory compliance 1.3.1 Regulatory compliance Request for information Requirement code Vendor response a. The system supports 21 CFR Part 11 and 40 CFR Part 3 requirements, including login security, settable automatic logouts, periodic requirements for mandatory password changes, limits on reusability of passwords, and full electronic signature. b. The system supports ISO/IEC 17025 requirements. c. The system supports HIPAA requirements. d. The system supports GALP and/or GAMP standards. e. The system supports the standards of The NELAC Institute. f. 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. g. The system meets government requirements for handling classified information and documents. h. The system maintains audit and specification violation trails of all data manipulation — such as result and header information changes — as consistent with all applicable regulations and standards. i. The system maintains audit trails at least as long as the records to which they pertain. j. The system's audit log retains all data, prohibits any deletions, allows user comments, and allows reporting of contained information. k. The system provides additional persistent auditing capabilities, such as the audit of cancelled tests and scheduled system functions. l. The system provides user-selectable NELAP-compliant internal chain of custody that tracks all specimens and associated containers from the time they are collected until disposed of. m. The system provides the ability to insert/manage secure electronic and/or digital signatures. n. The system incorporates automatic date and time stamping of additions, changes, etc. o. The system can automatically validate and approve data prior to being moved to the main database. 1.3.2 Security 1.3.2 Security Request for information Requirement code Vendor response a. The system allows administrators and other authorized users to configure multiple levels of user rights and security by site location, department, group, role, and/or specific function. b. The system allows administrators and users to reset user passwords. c. The system features and enforces adjustable rules concerning password complexity, reuse, and expiration. d. The system can lock a user out after a specified number of consecutive failed log-in attempts. e. The system provides the option for automatic user logout based on keyboard or mouse inactivity. f. The system makes authority checks to ensure only authorized individuals can use the system to perform an operation. g. The system allows authorized users to modify records, while also maintaining an audit trail of such actions. h. The system allows authorized users to manually delete records, while also maintaining an audit trail of such actions. i. The system prompts users to declare a reason for making changes to or deleting data in the system. j. The system provides email notification of lockout, security access, and improper workstation access. k. The system provides a mechanism to allow a user read-only access to stored data. l. The system allows authorized users to generate a detailed user access record. m. The system allows authorized users to review audit logs at will. n. The system allows authorized users to query and print chain of custody for items, cases, projects, and batches. o. The system allows supervisors to override chain of custody. p. The system automatically tracks when supervisors review critical result values. q. The system allows automatic and/or manual holds or locks to be placed on data to ensure it goes unaltered or remains retrievable during a retention period. r. The system can first feed data from connected non-CFR-compliant instruments through a virtual environment that is compliant (audit trailed, secure, versioned, etc.) before being stored. s. The system can control whether users are able to export data to portable long-term storage media like a USB flash drive or recordable DVD. t. The system employs automatic file encryption on stored data. u. The system employs checks to enforce permitted sequencing of steps and events. v. The system allows multiple users to connect simultaneously to a contract lab. w. The system provides read-only access to contract laboratory results. x. The system prohibits issuing reports outside of qualified areas while also allowing reports to be viewed locally or remotely based on security application limits and/or specimen ownership.

1.4 General system functions

1.4.1 General functions 1.4.1 General functions Request for information Requirement code Vendor response a. The system offers non-LIS trained personnel the ability to easily access system data via an intuitive, user-friendly Windows-type graphical user interface (GUI) which permits the display of data from specimen points, projects, and user-defined queries, and can be configured to language, character set, and time zone needs. b. The system allows authorized users to configure their GUI to a specific language, character set, and time zone. c. The system permits remote access for users, system admins, and support agents. d. The system allows for the use of navigation keys to freely move from field to field. e. The system allows tabular data to be sorted and filtered. f. The system can send on-screen output to a printer or file without contradicting view-only statuses. g. The system provides single data entry, automatically populates other data fields, and remembers pertinent and relevant data so it doesn't need to be re-entered, selected, or searched for. h. The system eliminates (or significantly reduces) redundant data entry and paper trails. i. The system contains one or more spell-check dictionaries that allow authorized users to add, edit, or remove entries. j. The system provides full database keyword and field search capability, including the use of multiple search criteria. k. The system includes the ability to search multiple databases, including those containing legacy data. l. The system allows users to build, save, and edit queries for future use. m. The system can automate the search for and extraction of pertinent data, including the export of that data to external applications for additional processing and calculation. n. The system cleanly converts migrated data to allow for reporting of historical specimen collections. o. The system allows for the specification of a retention period for captured data and can enact it based on date-based fields or a future event. p. The system can manage and store both sample- and non-sample-related data, including images from microscopes, GCMS scans of peaks, PDF files, spreadsheets, or even raw data files from instrument runs for later processing. q. The system can manage and store media objects like digital photos, bitmaps, movies, and audio files. r. The system issues sequential numbers for chain of custody. s. The system's numbering scheme allows for sub-numbering while maintaining parent-child relationships. t. The system efficiently utilizes standardized data input points and enhanced individual workload tracking. u. The system captures data from all laboratory processes, ensuring uniformity of statistical reporting and other electronic data shared with designated users of the data. v. The system can link objects to other objects, e.g. linking a standard operating procedure (SOP) to a test result. w. The system notifies users of events like the scheduling, receipt, and completion of tasks. x. The system includes the ability to set up alerts via email. y. The system has real-time messaging capabilities, including instant messaging to one or more users. z. The system supports the use of a voice recognition system (for navigation or transcription) or has that functionality. aa. The system offers integrated or online user help screens. ab. The system includes clinical trial management tools. ac. The system can handle patient case management and assignment. ad. The system provides physician, clinic, and contract lab management tools. ae. The system provides outreach and call list management tools. af. The system supports multi-site, multi-lab, or multi-physician groups. ag. The system provides disease tracking functionality. ah. The system monitors turnaround time, from test request to clinician review. ai. The system is veterinary-compatible. 1.4.2 Configuration and customization 1.4.2 Configuration and customization Request for information Requirement code Vendor response a. The system can be configured to meet the workflow of a laboratory without additional programming. b. The system architecture is modular or extensible and can easily and efficiently be modified to facilitate the addition of new functionality as business needs change. c. The system has an application programming interface (API) or a similar software development toolkit (SDK). If web-based, the API should support Simple Object Access Protocol (SOAP), representational state transfer (REST), or both. d. The system can expand to accommodate a new discipline. e. The system supports customized screens with user-definable information specific to a customer, department, analysis, etc. f. The system allows the administrator to create custom screens, applications, and reports. g. The system permits users to create templates and worksheets for standardizing analysis pages, patient pages, test ordering pages, and/or the reporting processes. h. The system allows a user to independently add fields without requiring reconfiguration of the system, even after routine upgrades and maintenance. i. The system allows a user to independently add universal fields on all specimens logged into the system at any time during or after implementation, while neither voiding the warranty nor requiring vendor review at a later date. j. The system provides flexible and customizable mapping dictionaries for interconversion of different standards and more. k. The system supports the definition and maintenance of edit tables and lists. l. The system supports customizable test, panel, and profile libraries. m. The system supports customization of test pick lists based on specialty utilization. n. The system dynamically changes captions (labels) on system fields. o. The system has dynamically configurable limit periods and notification hierarchy. p. The system provides optional configuration choices for correctional facilities. q. The system allows for the integration of additional printers and scanners both locally and externally. 1.4.3 Receiving and scheduling 1.4.3 Receiving and scheduling Request for information Requirement code Vendor response a. The system tracks status and workflow of the accession throughout the laboratory lifecycle, from submission to final analysis, including receiving, diagnostic testing, diagnostic test result reporting, and billing. b. The system supports barcoded specimen labeling and tracking. c. The system allows users to create, manage, and track viewable specimen container schemata. d. The system creates and maintains a unique electronic accession record for each accession received. e. The system supports standard-format digital picture and document upload and attachment to electronic accession records. f. The system supports a user-configurable, spreadsheet-style, templated multi-specimen (batch) login without requiring additional programming. g. The system features order entry rules for better managing duplicate orders, rejecting inappropriate tests, identifying inappropriate containers, rerouting tests to outside labs, etc. h. The system supports the modification of specimen or specimen batch information prior to actual multi-specimen (batch) login. i. The system supports ad-hoc specimens not predefined in the specimen point list during multi-specimen (batch) login. j. The system creates, saves, and recalls pre-login groups for routine specimens to simplify recurring logins. k. The system streamlines the login of recurring specimen projects. l. The system allows standing orders and test schedules to be defined for future orders. m. The system automatically generates labels for recurring specimens and specimen groups. n. The system can automatically split and manage orders requiring multiple testing locations. o. The system can differentiate "investigation use only" and "research use only" tests. p. The system can automatically generate and manage administrative documents for genetics tests. q. The system allows authorized users to generate user-definable or rules-based chain of custodies, worksheets, routing sheets, and custom labels upon specimen login. r. The system provides a comprehensive view of all specimens and projects in the system using a color-coded status view of the current and scheduled specimens via user-configurable templates, all without requiring additional programming. s. The system includes environmental monitoring (EM) functionality or integrate with an external EM product. t. The system prevents a specimen from being placed in a report queue until approved. u. The system includes comprehensive scheduling, tracking, and flow management of specimens, including across multiple sites. v. The system allows authorized users to accept, cancel, re-run, and override attributes of one or multiple tests for a given patient. w. The system allows authorized users to review the available test types in the system, including their reference range and units of measure. x. The system allows multiple diagnosis codes to be attached to an ordered test. y. The system has a "miscellaneous" test code to allow a test undefined in the system to be ordered and billed. z. The system automatically runs medical necessity checks (based on diagnosis codes) on a requested test. aa. The system automatically makes duplicate order checks and notifies applicable users upon detection. ab. The system can import and utilize the Centers for Medicare and Medicaid Services' (CMS') National and Local Coverage Determinations files. ac. The system can track and manage advance beneficiary notices (ABNs) from CMS as needed. ad. The system allows authorized users to schedule routine specimens on an hourly, daily, weekly, or monthly basis, allowing them to be enabled and disabled as a group. ae. The system generates an hourly, daily, weekly, or monthly specimen collection schedule from a scheduling database. af. The system schedules and assign tasks based on available inventory and personnel. ag. The system supports automatic assignment and scheduling of analysis requests. ah. The system receives accession/analysis request information from web-enabled forms. ai. The system electronically receives and processes collection and analysis request information and schedules from third parties. aj. The system has an inter-lab transfer function. ak. The system processes automated uploading of field-derived specimen collection data. al. The system allows users to handle billable and non-billable tests on the same accession. am. The system supports tracking of shipping and receiving. 1.4.4 Analysis and data entry 1.4.4 Analysis and data entry Request for information Requirement code Vendor response a. The system supports a variety of test protocols, each capable of storing test comments, test required, and special information like GCMS conditions or special objects associated with the test. b. The system provides and enforces normal data range values for diagnostic tests. c. The system includes default input values for diagnostic tests. d. The system provides for a single test code requiring multiple analytes as targets. e. The system allows authorized users to make a test code inactive across one or more sites while retaining it for audit and reporting purposes. f. The system limits test code authorization to only qualified personnel and maintain their certification(s) to run assigned tests. g. The system supports and qualifies text-based tests. h. The system supports single-component tests such as pH, BOD, CD, etc. i. The system allows users to specify a single-component, multi-component, or narrative text test or group of tests, which represent all tests required. j. The system permits user-generated and modifiable calculations (based on a formulaic language) to be applied to all tests. k. The system distinguishes between routine and duplicate analysis. l. The system provides an overview of all outstanding tests/analyses for better coordination of work schedules. m. The system notifies analysts of applicable safety hazards associated with a specimen, reagent, or test before testing begins. n. The system electronically transfers an item during testing from one functional area to another. o. The system's user interface displays visual indicators such as status icons to indicate a specimen's status in the workflow. p. The system allows file transfer of data from instruments via intelligent interfaces or multi-specimen/multi-test ASCII files, with full on-screen review prior to database commitment. q. The system permits manual data entry into an electronic worksheet of test measurements and results. r. The system allows incorrectly inputted data to be manually corrected. s. The system prevents out-of-range and other critical results from being posted as final. t. The system provides colored visual indication of previously entered data as well as new data associated with a single specimen when a result is entered, with the indicator changing color if the value is out of specification. u. The system allows automated or semi-automated data insertion. v. The system stores non-narrative textual results in searchable fields. 1.4.5 Post-analysis and validation 1.4.5 Post-analysis and validation Request for information Requirement code Vendor response a. The system updates specimen/item status when tests are completed. b. The system automatically reorders a test or orders additional tests if results don't meet lab-defined criteria, especially when the original specimen is still available. c. The system reads results from previously entered tests to calculate a final result and immediately displays the calculated result. d. The system allows authorized users to review all analytical results, including pricing, spec violations, history or trend analysis by analyte, and comments. e. The system graphically displays the results of one or more tests in a graph (normalized or otherwise) for the purpose of visualizing data or searching for possible trends. f. The system allows on-screen review of the stored test result, diluted result with corrected method detection limits (MDLs), and qualifiers after running samples for multiple dilutions as in gas chromatography–mass spectrometry (GC-MS). g. The system displays the standard operating procedure (SOP) associated with each test result to ensure proper techniques were used. h. The system stores test-related analysis comments with the test. i. The system provides auto-commenting for common laboratory result comments. j. The system is capable of displaying entered order and test comments as an onscreen alert for testing and other personnel. k. The system provides for high-volume multi-component transfers of test results, with the ability to automatically match samples to data files in either a backlog mode or a designated file mode, to parse the data, and to review and commit the sample data. l. The system's results validation process access all information about a sample or group of samples, including comments or special information about the sample. m. The system's results validation process checks each result against its individual sample location specifications (both warning and specification limits). n. The system supports validation at the analysis and sample level, while also prohibiting sample validation when analysis validation is incomplete. o. The system uses a menu-driven process for results validation. p. The system provides secure electronic peer review of results. q. The system clearly differentiates released preliminary data from fully validated results. r. The system validates/approves data prior to being moved to the main database. s. The system fully manages all aspects of laboratory quality control, including the reporting and charting of all quality control data captured in the lab. t. The system provides a base for a quality assurance program, including proficiency testing, scheduled maintenance of equipment, etc. u. The system distinguishes QA/QC duplicates from normal samples. v. The system allows QA/QC tests to be easily created and associated with the primary analytical test. w. The system allows manual entry of QA and QC data not captured as part of the system's regular processes. x. The system calculates monthly QA/QC percentages for testing. y. The system automatically flags out-of-range quality control limits. z. The system is able to flag results for aspects other than being out-of-range, including testing location, patient age, etc. aa. The system checks data files for specification and corrects them for specific reporting and analyte limits and qualifiers like dilution factor, automatically assigning qualifiers based on project analyte limiting. 1.4.6 Instruments 1.4.6 Instruments Request for information Requirement code Vendor response a. The system bilaterally interfaces with instruments and related software. b. The system downloads data directly from laboratory instruments. c. The system permits the defining and exporting of sequences to instruments. d. The system tracks and reports on the usage of attached laboratory instruments. e. The system allows automatic or manual reservation/scheduling of laboratory instruments. f. The system automatically (or manually allow an authorized user to) removes an instrument from potential use when it falls out of tolerance limit or requires scheduled calibration. g. The system provides a database of preventative maintenance, calibration, and repair records for laboratory equipment, preferably supported by standardized reporting. h. The system schedules calibration, verification, and maintenance tasks in the worksheets or work flow process and make that schedule available for viewing. i. The system allows users to create and edit instrument maintenance profiles. 1.4.7 External system interfaces 1.4.7 External system interfaces Request for information Requirement code Vendor response a. The system supports a library of common electronic data deliverable (EDD) formats. b. The system transfers data to and from another record management system. c. The system integrates with Microsoft Exchange services. d. The system imports data from and exports data to Microsoft Word, Excel, and/or Access. e. The system can interface with non-Microsoft programs. f. The system interfaces with external billing systems. g. The system interfaces with enterprise resource planning (ERP) systems. h. The system interfaces with external contract or reference laboratories to electronically send or retrieve datasheets, analysis reports, and other related information. i. The system exchanges data with National Identification System (NAIS) tracking systems. j. The system generates and exchanges data with other systems using Health Level 7 (HL7) standards. k. The system leverages the application programming interface (API) of other systems to establish integration between systems. l. The system provides a real-time interface for viewing live and stored data transactions and errors generated by interfaced instruments and systems. m. The system transmits status changes of specimens, inventory, equipment, etc. to an external system. n. The system directs output from ad-hoc queries to a computer file for subsequent analysis by other software. o. The system supports the manual retransmission of data to interfaced systems. p. The system supports dockable mobile devices and handle information exchange between them and the system. q. The system supports the use of optical character recognition (OCR) software. 1.4.8 Reporting 1.4.8 Reporting Request for information Requirement code Vendor response a. The system includes a versatile report writer and forms generator that can generate reports from any data in tables. b. The system includes a custom graphic generator for forms. c. The system interfaces with a third-party reporting application. d. The system allows the development of custom templates for different types of reports. e. The system maintains template versions and renditions, allowing management and tracking of the template over time. f. The system generates template letters for semi-annual reports. g. The system supports report queries by fields/keys, status, completion, or other variables. h. The system use Microsoft Office tools for formatting reports. i. The system supports multiple web browsers for viewing online reports. j. The system generates, stores, reproduces, and displays laboratory, statistical, and inventory reports on demand, including narrative. k. The system includes several standard reports and query routines to access all specimens with the pending status through a backlog report that includes the following criteria: all laboratory, department, analysis, submission date, collection date, prep test complete, location, project, specimen delivery group, and other user-selectable options. l. The system indicates whether a report is preliminary, amended, corrected, or final while retaining revision history. m. The system supports both structured and synoptic reporting. n. The system generates management and turn-around time reports and graphs. o. The system generates customized final reports. p. The system automatically generates laboratory reports of findings and other written documents. q. The system automatically generates individual and aggregate workload and productivity reports on all operational and administrative activities. r. The system automatically generates and transmits exception trails and exception reports for all entered and/or stored out-of-specification data. s. The system generates a read-only progress report that allows for printed reports of specimen status and data collected to date. t. The system provides an ad-hoc web reporting interface to report on user-selected criteria. u. The system automatically generates and updates control charts. v. The system generates QA/QC charts for all recovery, precision, and lab control specimens via a full statistics package, including Levy-Jennings plots and Westgard multi-rule. w. The system displays history of previous results for an analyte's specimen point in a tabular report, graphic trend chart, and statistical summary. x. The system automatically generates and posts periodic static summary reports on an internal web server. y. The system transmits results in a variety of ways including fax, e-mail, print, and website in formats like RTF, PDF, HTML, XML, DOC, XLS, and TXT. z. The system electronically transmits results via final report only when all case reviews have been completed by the case coordinator. aa. The system includes a rules engine to determine the recipients of reports and other documents based on definable parameters. ab. The system allows database access using user-friendly report writing and inquiry tools. ac. The system supports automatic reporting to the state based on state-level health department rules. 1.4.9 Laboratory management 1.4.9 Laboratory management Request for information Requirement code Vendor response a. The system allows the creation, modification, and duplication of user profiles. b. The system allows entry, maintenance, and administration of patient records and is able to track multiple patient encounters. c. The system allows entry, maintenance, and administration of customers, suppliers, and other outside entities. d. The system allows patients, customers, suppliers, physicians, and other such entities to be flagged as either active or inactive. e. The system allows the creation, modification, and maintenance of user training records and associated training materials. f. The system supports the ability to set up separate security, inventory, reporting, etc. profiles across multiple facilities. g. The system allows the management of information workflow, including notifications for requests and exigencies. h. The system allows the management of documents like SOPs, MSDS, etc. to better ensure they are current and traceable. i. The system allows the management and monitoring of resources by analyst, priority, analysis, and instrument. j. The system allows authorized persons to select and assign tasks by analysts, work group, instrument, test, specimen, and priority. k. The system allows authorized persons to review unassigned work by discipline and by lab. l. The system allows authorized persons to review pending work by analyst prior to assigning additional work. m. The system manages and reports on reference specimens, reagents, and other inventory, including by department. n. The system automatically warns specified users when inventory counts reach a definable threshold and either prompt for or process a reorder. o. The system allows authorized users to monitor and report on reference and reagent creation, use, and expiration. p. The system allows authorized users to search invoice information by invoice number, account number, accession, payment types, client, or requested diagnostic test(s). q. The system includes performance assessment tracking. r. The system receives, records, and maintains customer and employee feedback and applies tools to track the investigation, resolution, and success of any necessary corrective action. s. The system monitors proficiency test assignment, completion, and casework qualification for analytical staff. t. The system provides analysis tools to better support laboratory functions like resource planning, productivity projections, workload distribution, and work scheduling, and those tools display information in a consolidated view, with the ability to drill down to more detailed data. u. The system calculates administrative and lab costs. v. The system captures and maintains patient, submitter, supplier, and other client demographics and billing information for costing, invoicing, collecting, reporting, and other billing activities. w. The system supports multiple customer payment sources (e.g. grants). x. The system supports multi-tiered pricing based on patient type and location. y. The system tracks number of visits per specific industry.

1.5 System-specific

The system-specific addendum can be found here.

1.6 Industry-specific

The industry-specific addendum can be found here.

1.7 Custom requirements

1.7 Custom requirements Request for information Requirement code Vendor response a. b. c. d. e. f. g. h. i. h. i. j.