User:Shawndouglas/sandbox

System questionnaire

This questionnaire lists the extensive requirements of a laboratory informatics system, primarily of a LIMS, though these requirements could easily apply to other informatics systems. The intention of this document is 1. to assist labs with identifying their system needs and 2. to help labs better determine if a specific vendor/product meets their requirements in the form of a request for information (RFI).

This questionnaire is comprehensive and includes many items that do not apply to every lab. Additionally, some laboratories' requirements include a functionality item not common to other labs. Section 1.5 "Industry-specific questionnaire" contains a selection of those industry-specific requirements and will continue to be amended over time. The last section, 1.6 "Custom system functions questionnaire," is designed for the vendor to insert any additional functionality that doesn't fall under the categories provided.

When referencing a particular item for someone else, use the section number followed by the requirement letter, e.g. 1.4.2.f for "Does the system allow the system admin to create custom screens, apps, and reports?"

Requirement code and notes

In responding to each requirement, the vendor must select a requirement code from the following:

• Y: Meets requirement in commercial off-the-shelf solution as delivered/configured (or vendor provides service)
• YC: Meets requirement only with customization (additional code, using a third-party application, etc.)
• N: Does not meet requirement
• I: Informational response only, N/A

The vendor should ideally enter a requirement code and a response for each functionality question.

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

1.2 Informationt technology

1.2 Information technology 1.2.1 Information technology: general Functional requirement Request for information Vendor response a. Does your system contain a single database that supports multiple laboratory sites and departments? b. Does your system's database conform to the Open Database Connectivity Standard (ODBC)? c. Does your system interface with the database using Active Server Pages (ASP) and ASP.net? d. Did you design your system so upgrades to the back-end database do not require extensive reconfiguration or effectively cripple the system? Please describe. e. Did you design your system to not be impacted by multiple users or failover processes? Please describe. f. Does your system apply security features to all system files? g. Does your system apply login security to all servers and workstations accessing it? h. Does your system provide a workstation and server authentication mechanism? i. Does your system apply Secured Socket Layer (SSL) encryption on the web client interface? j. Does your system encrypt client passwords in a database with support for multi-case and special characters? k. Does your system provide all secured users access to its data via the Internet, LAN, or direct modem connection? l. Does your system use TCP/IP as its network transport? m. Does your system contain an archive utility that doesn't require off-line mode? n. Does your system provide local restore capability without support intervention? o. Does your system maintain the transactional history of system administrators? 1.2.2 Information technology: hardware environment Functional requirement Request for information Vendor response a. Does your system prove compatible with a variety of hardware environments? Please describe how. 1.2.3 Information technology: software environment Functional requirement Request for information Vendor response a. Does your system utilize a non-proprietary database such as Oracle or Microsoft SQL Server? Please explain. b. Does your system prove compatible with a variety of software environments? Please describe how.

1.3 Regulatory compliance requirements

1.3 Regulatory compliance requirements Functional requirement Requirement code Notes a. System has security consistent with 21 CFR Part 11 and 40 CFR Part 3, including login security, settable automatic logouts, periodic requirements for mandatory password changes, limits on reusability of passwords, and full electronic signature b. System maintains audit trail and specifications violation trails, including result changes and header information changes, as well as the user, date/time, and a required reason for the changes as a standard part of the application c. System maintains an audit trail of all data manipulation, consistent with all applicable regulations and standards d. System provides user selectable NELAP-compliant internal chain of custody that tracks all samples and associated containers from the time they are collected until disposed of e. System meets all standards of The NELAC Institute f. System provides persistent auditing capabilities g. System meets government requirements for handling classified information and documents h. System includes automatic date and time stamping i. System provides the ability to insert/manage secure electronic and/or digital signatures j. System supports ISO/IEC 17025 k. System supports 21 CFR Part 11 l. System supports 40 CFR Part 3 m. System supports HIPAA requirements n. System supports GALP and/or GAMP standards

1.4 General functional requirements

1.4 General functional requirements 1.4.1 General Functional requirement Requirement code Notes a. 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. System supports barcoded specimen labeling and tracking c. System supports multiple customer payment sources (e.g. grants} d. System can track current status of diagnostic tests in an accession e. System contains spell-check dictionary that allows authorized users to add, edit, or remove entries f. System includes administrator ability to reset user passwords g. System can interface with or import existing data h. System can be configured to meet the characteristics of the laboratory i. System capable of storing multiple sample-related objects such as pictures, documents, PDF files, etc., including any instrument-generated format outputs from equipment j. System capable of storing sample comments, special information fields which are project- or sample-specific, user defined fields, data objects like scanned chain of custodies and digital photos of such items as sample events, bitmaps, movies, .wav audio files, and Word documents k. System allows user to store object files such as pictures from microscopes, GCMS scans of peaks, or even raw data files from instrument runs for later processing l. System provides non-LIMS trained personnel access to the LIMS data via a simple Windows-type browser interface which permits the display of data from sample points, projects, or user-defined queries m. System provides for application-based security by limiting external users to functions they are password-privileged to perform n. System provides sample tracking, from login through final reporting and invoicing o. System produces internal chain of custody data to track individual sample containers and test results p. System eliminates (or significantly reduces) redundant data entry and paper trail q. System manages archived, paper-based laboratory records r. System has a screen print function s. System has an analyst communication log t. System has configurable role-based security u. System utilizes role-based presentation of menus and functions v. System has supervisor override of chain of custody w. System provides automatic logout based on keyboard or mouse inactivity x. System prompts users for a reason for changes to database record y. System allows authorized personnel to review audit logs z. System's numbering scheme allows for sub-numbering while maintaining parent-child relationships aa. System able to print chain of custody for items, cases, projects, and batches ab. System has an inter-lab transfer function ac. System allows queries of legacy data ad. System audit log retains all data, prohibits any deletions, and allows user comments ae. System search engine permits multiple search criteria af. System permits remote access for users, system admins, and support agents ag. System supports the definition and maintenance of edit tables and lists ah. System allows modification of records by system admins, with audit trail ai. System allows entry, maintenance, and administration of customers, suppliers, and other outside entities aj. System links or embeds standard operation procedure (SOP) access ak. 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 al. System provides an intuitive, user-friendly graphical user interface (GUI), consistent with Microsoft products am. System captures data from all laboratory processes, ensuring uniformity of statistical reporting and other electronic data shared with designated users of the data an. System provides data archival and retention functionality ao. System efficiently utilizes standardized data input points and enhanced individual workload tracking ap. System provides full database keyword and field search capability aq. System provides read-only access to contract laboratory results ar. System allows use of navigation keys to freely move from field to field as. System allows data tables to be sorted at. System issues sequential numbers for chain of custody au. System allows multiple users to connect simultaneously to contract lab av. System notifies users of events like the scheduling, receipt, and completion of tasks aw. System includes the ability to set up alerts via email ax. System includes the ability to search multiple databases ay. System supports multiple users entering data simultaneously az. System cleanly converts migrated data to allow for reporting of historical sample collection 1.4.2 Configuration and customization Functional requirement Requirement code Notes a. System allows user to independently add fields without requiring reconfiguration of the system after routine upgrades and maintenance b. System supports customized screens with user-definable information specific to an analysis c. System allows addition of universal fields on all samples logged into the system at any time during or after implementation, while neither voiding the warranty nor requiring vendor review at a later date d. System can expand to accommodate a new discipline e. System can integrate additional printers and scanners f. System allows the system admin to create custom screens, apps, and reports g. System dynamically changes captions (labels) on system fields h. System has dynamically configurable limit periods and notification hierarchy i. System can be easily and efficiently modified to meet lab growth and changing business needs 1.4.3 Receiving and scheduling Functional requirement Requirement code Notes a. System creates and maintains an electronic accession record for each accession received b. System supports electronic accession records with digital picture and document uploads in standard formats c. System allows users to handle billable and non-billable tests on the same accession d. System supports tracking of shipping and receiving e. System can receive accession/analysis request information from web-enabled forms f. System can process automated uploading of field-derived sample collection data g. System supports a user-configurable, spreadsheet-style, templated multi-sample login without requiring additional programming h. System supports the modification of sample or sample batch information prior to actual multi-sample login i. System supports ad-hoc samples not predefined in the sample point list during multi-sample login j. System can print user-definable chain of custodies, worksheets, routing sheets, and custom labels upon login k. System creates, saves, and recalls pre-login groups for routine samples to simplify recurring logins l. System includes comprehensive sample scheduling, tracking, and sample flow management m. System provides a comprehensive view of all samples and projects in the system using a color-coded status view of the current and scheduled samples via user configurable templates, all without requiring additional programming n. System schedules routine samples on an hourly, daily, weekly, or monthly basis, allowing them to be enabled and disabled as a group o. System streamlines login of recurring sampling projects p. System supports automatic assignment of analysis requests q. System can generate a monthly sampling schedule from a schedule database q. System can generate labels for recurring samples and sample groups 1.4.4 Analysis and data entry Functional requirement Requirement code Notes a. System provides auto-commenting for common laboratory result comments b. System provides normal data range values for diagnostic tests c. System includes default input values for diagnostic tests d. System stores non-narrative textual results in searchable fields e. System's user interface displays visual indicator such as status icons to indicate a sample's status in the workflow f. System allows incorrectly inputted data to be corrected g. System able to fully manage all aspects of laboratory quality control as well as report and chart all quality control data captured in the lab h. 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 i. System provides for a single test code requiring multiple analytes as targets j. System supports and qualifies text-based tests j. System supports single-component tests such as pH, BOD, CD, etc. k. System allows user to specify a single-component, multi-component, or narrative text test or group of tests, which represent all tests required l. System allows QA/QC test to be easily created and associated with the primary analytical test m. System provides colored visual indication of previously entered data as well as new data associated with a single sample When a result is entered, with the indicator changing color if the value is out of specification n. System allows file transfer of data from instrument or user-generated files, with full on-screen review prior to database commitment o. System reads results from previously entered tests to calculate a final result and immediately displays the calculated result p. System permits result entry via intelligent instrument interfaces or multi-sample/multi-test ASCII files q. System provides high-volume multi-component transfer of results with 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. r. 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 s. System allows on-screen review of the stored result, diluted result with corrected MDLs, and qualifiers after running samples for multiple dilutions such as GCMS t. System stores test-related analysis comments with the test u. System displays the standard operating procedure (SOP) associated with each test result to ensure proper techniques are used v. System limits LIMS test code authorization to only qualified personnel and maintains their certification(s) to run assigned tests w. System uses a menu-driven process for results validation x. System's results validation process can access all information about a sample or group of samples, including comments or special information about the sample y. System allows authorized users to review all analytical results, including pricing, spec violations, history or trend analysis by analyte, and comments z. System validation screens check each result against its individual sample location specifications (both warning and specification limits) aa. System supports validation at the analysis and sample level, while also prohibiting sample validation when analysis validation is incomplete ab. System permits user-generated and modifiable Excel calculations on all tests ac. System automatically flags out-of-range quality control limits ad. System provides an overview of all outstanding analyses for better coordination of work schedules ae. System permits manual data entry into an electronic worksheet of test measurements and results af. System electronically transfers an item during testing from one functional area to another ag. System provides secure electronic peer review ah. System provides a base for a quality assurance program, including proficiency testing, scheduled maintenance of equipment, etc. ai. System allows automated or semi-automated data insertion aj. System updates sample/item status when tests are completed ak. System calculates monthly QA/QC percentages for testing al. System distinguishes between QA/QC duplicates and normal samples am. System distinguishes between routine and duplicate analysis an. System tracks changes in data structure and content ao. System allows user-friendly changes of data ap. System can validate/approve data prior to being moved to the main database 1.4.5 Instruments Functional requirement Requirement code Notes a. System bilaterally interfaces with instruments and related software b. System provides a database of preventative maintenance, calibration, and repair records for laboratory equipment, preferably supported by standardized reporting c. System downloads data directly from laboratory instruments d. System schedules calibration/verification tasks in the worksheets or work flow process e. System permits the defining and exporting of sequences to instruments 1.4.6 External system interfaces Functional requirement Requirement code Notes a. System can direct output from ad-hoc queries to a computer file for subsequent analysis by other software b. System can exchange data with National Identification System (NAIS) tracking systems c. System provides a library of common and/or basic electronic data deliverable (EDD) formats d. System can transfer data to and from another record management system e. System supports dockable mobile devices f. System can import data from and export data to Microsoft Word, Excel, and/or Access g. System integrates with Microsoft Exchange services h. System can interface with contract laboratories to electronically retrieve datasheets, sample analysis, and other related information i. System can interface with non-Microsoft programs 1.4.7 Reporting Functional requirement Requirement code Notes a. System clearly differentiates released preliminary data from fully validated results b. System electronically transmits results via final report only when all case reviews have been completed by the case coordinator c. System can automatically post periodic static summary reports on an internal web server d. System provides ad-hoc web reporting interface to report on user-selected criteria e. System can transmit results in a variety of ways including fax, e-mail, print, and website in formats like RTF, PDF, HTML, XML, DOC, XLS, and TXT f. System supports multiple web browsers when viewing online reports g. System capable of creating QA/QC charts for all recovery, precision, and lab control samples via a full statistics package h. System includes several standard reports and query routines to access all samples with the pending status through a backlog report that includes the following criteria: all laboratory, department, analysis, submittal date, collection date, prep test complete, location, project, sample delivery group, and other user-selectable options i. System produces a read-only progress report that allows printed reports of sample status and data collected to date j. System automatically creates and transmits a separate exception report for all stored out-of-specification data k. System displays history of previous results for an analyte's sample point in a tabular report, graphic trend chart, and statistical summary l. System creates and transmits exception trails and reporting for all entered out-of-specification results m. System permits sample progress reports to be viewed locally or remotely based on security application limits and/or sample ownership n. System prevents a sample from being placed in a report queue until approved o. System includes a versatile report writer and forms generator p. System includes a custom graphic generator for forms q. System allows development of specific templates for different types of reports r. System can produce management and turn-around time reports and graphs s. System can produce customized final reports t. System can create and automatically update control charts u. System generates, stores, reproduces, and displays laboratory reports on demand, including narrative v. System generates, stores, reproduces, and displays laboratory, statistical, and inventory reports on demand, including narrative w. System can send on-screen output to printer or file x. System allow users to query and print chain of custody y. System supports report queries by fields/keys, status, completion, or other variables z. System prohibits issuing reports outside of qualified areas aa. System can generate reports from any data in tables ab. System uses Microsoft Office tools for formatting reports ac. System can automatically produce laboratory reports of findings and other written documents ad. System can automatically produce individual and aggregate workload and productivity reports on all operational and administrative activities ae. System can generate template letters for semi-annual reports af. System permits database access using user-friendly report writing and inquiry tools ag. System maintains template versions and renditions, allowing management and tracking of the template over time 1.4.8 Laboratory management Functional requirement Requirement code Notes a. System allows search of invoice information by invoice number, account number, accession, payment types, client, or requested diagnostic test(s) b. System allows system administration ability to configure multiple levels of user rights by site location, department, or job functions c. System allows management of documents like SOPs, MSDS, etc. to better ensure they are current and traceable d. System provides email notification of lockout, security access, and improper workstation access e. System includes a performance assessment tracking method f. System allows users to monitor reagent use and chemical expirations g. System monitors proficiency test assignment, completion, and casework qualification for analytical staff h. System allows authorized persons to assign work to analysts i. System allows authorized persons to review pending work by analyst prior to assigning additional work j. System allows authorized persons to review unassigned work by discipline and lab k. System permits the management of information workflow, including notifications for requests and exigencies l. System allows authorized persons to select and assign tasks by analysts, work group, instrument, test, sample, and priority m. System permits records management and monitors resources by analyst, priority, analysis, and instrument n. System provides analysis tools for laboratory operations to better support resource planning, productivity projections, workload distribution, and work scheduling o. System calculates administrative and lab cost p. System tracks number of visits per specific industry p. System allows creation, modification, and duplication of user profiles

1.5 Industry-specific requirements

1.5 Industry-specific requirements 1.5.1 Agriculture: functional requirements Functional requirement Requirement code Notes a. System permits input and query of information such as (but not limited to) client ID numbers, animal species, animal breed, animal sex, animal diagnostic test performed, animal diagnostic test result, client or bill to zip code, program or funding codes, date ranges, lab department, case coordinator, and lab technician b. System makes report output available online for external and internal web viewing c. System permits manual override of allowable test/species combinations for circumstances outside the norm 1.5.2 Forensics: functional requirements Functional requirement Requirement code Notes a. System uses barcode technology to identify and track property/evidence b. System provides functionality for each discipline, including latent prints, crime scene unit, multi-media lab, evidence control, ballistics, polygraph, forensic chemistry, and DNA c. System internally manages case workflow, including case assignment, case forwarding, and notification d. System tracks court testimony e. System supports additional segmentation of evidence f. System provides a record locate function by name, agency, ORI, etc. g. System records transaction date/time/persons associated with movement of lab evidence h. System meets ASCLD standards for certified lab evidence transfers i. System implements security functions such as password, PIN, etc. in evidence transfer j. System supports ASTM standards, including evidence handling and numbering k. System supports open field numbering to create evidence packets l. System provides evidence inventory with report capability m. System sets automatic flags and processing for evidence return n. System supports a statewide single case number o. System provides a "search for prior submission" function p. System requires case notes, data, and reports to be previewed before approval q. System provides report templates with variable fields for things such as case, item results, and conclusion r. System allows customer case status checking without staff intervention s. System makes objects associated with a case or submission accessible only from within the application t. System manages inventory of chemical, ammo, supplies, etc. u. System permits authorized users to define analytical parameters based on case and standard operation procedure (SOP) v. System permits supervisor or assignee to review all pending cases before assignment to staff w. System lists evidence currently or recently checked out by analyst x. System allows authorized users to configure case reports for location y. System links system and lab case numbers or Z (database) numbers z. System displays individual examiner workload/productivity in a consolidated view, with ability to drill down to more detailed data aa. System facilitates sharing of information with federal, state, and local law enforcement agencies ab. System provides complete, accurate, and timely processing and tracking of evidence, reports, and statistical information ac. System supports submission of requests for forensic examination electronically via e-mail, the FDL intranet, or FTP server ad. System provides automated, limited remote access to database for case status inquiries and to view case reports ae. System supports analysis of document and fingerprint evidence af. System provides automated chain of custody for all items of evidence ag. System supports documentation of expert witness testimony in courts of law and other judicial proceedings ah. System permits analysis of evidence in support of intelligence activities, including dissemination of document intelligence, document analysis, and other technical information to the law enforcement community ai. System supports data collection on meeting forensic case requester and case return deadlines 1.5.3 Medical and health: functional requirements Functional requirement Requirement code Notes a. System can automatically report any diagnostic test results deemed "suspect" or "positive" for reportable diseases 1.5.4 Environmental, water, and wastewater: functional requirements Functional requirement Requirement code Notes a. System provides a flexible procedure for assigning location codes or sample types for each default sample point, including tests required, report types, invoice information, maximum holding time, project accounts, and location description; each location code has an upper and lower warning limit, target specification for every analyte assigned, and stored defaults for all user-defined universal fields, special project fields, and sample comments b. System can calculate surcharge fees for each industry c. System compiles cost data for each industry in the database d. System stores permits for each industry e. System links permit criteria with significantly non-compliant criteria f. System generates notices of violation according to permit criteria and local limits g. System stores standard operating procedures (SOPs) for all pretreatment procedures h. System links all lab results with the correct reporting test method i. System generates correspondence letters for permit renewals and new permits j. System generates permit, permit application, directions for the application, and semi-annual report templates with fields like "name of industry," "mailing address," "SIC code," "permit number," and "contact name" k. System generates documentation for filing charges l. System generates reminder notices for citation dates m. System able to index all industries/companies by Standard Industrial Classification (SIC) codes n. System able to index all industries/companies by: categorical and non-categorical, exempt and non-exempt, alphabetical order, permit number, bar code, permit due dates, as well as daily, weekly, biweekly, monthly, quarterly, bi-annual, and annual o. System contains an address book for all programs in environmental compliance that indexes alphabetically, by industry, by address, etc. p. System indexes and compiles lists of industries that are in non-compliance/violation q. System can calculate surcharge from chain of custodies and data results r. System permits entering matrix duplicates for oil and grease samples s. System can determine violation by either combined waste stream formula or local limits t. System generates a report that determines if an industry is in significant non-compliance (SNC) u. System generates sampling cost reports for each industry, which includes the number of visits, analysis, calculated administrative cost, tubing cost, and duplicate sample cost, etc. v. System generates a biochemical oxygen demand (BOD) and total suspended solids (TSS) result report for industries w. System generates and prints industrial reports, sampling, inspections, fact sheets, citations, formal charges, correspondence letters, and industrial permits x. System generates a special report for HAZMAT incidents, storm water violations, spills/slugs, and local limit violators y. System complies with the Cross Media Electronic Reporting Rule (CROMERR) of Title 40 CFR Part 3 z. System generates corresponding letters/templates for special and routine cases (e.g. industrial waste, permit renewals, semi-annual reports)

1.6 Custom functional requirements

1.6 Custom functional requirements Functional requirement Requirement code Notes a. Enter your own unique requirement here