LII:LIMS and laboratory informatics questionnaire

The intention of this document is 1. to assist labs searching for a laboratory informatics product 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). The idea is to allow users to incorporate a standardized specifications sheet in their comparison of various LIMS and other laboratory informatics products.

This questionnaire lists the extensive requirements of a LIMS as well as other laboratory informatics systems. (See below for more about this.) The questionnaire is organized such that sections 1.0 through 1.4 offer questions applicable to most any laboratory informatics system, be it a LIMS or an ELN. Section 1.5 covers functionality found specifically in software systems other than LIMS.

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 1.6 "Industry-specific" contains a selection of those industry-specific requirements and will continue to be amended over time. The last section, 1.7 "Custom functions," 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 your system allow the administrator to create custom screens, applications, and reports? Please give details."

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 meets government requirements for handling classified information and documents.
g. 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.
h. The system maintains audit trails at least as long as the records to which they pertain.
i. The system's audit log retains all data, prohibits any deletions, allows user comments, and allows reporting of contained information.
j. The system provides additional persistent auditing capabilities, such as the audit of cancelled tests and scheduled system functions.
k. 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.
l. The system provides the ability to insert/manage secure electronic and/or digital signatures.
m. The system incorporates automatic date and time stamping of additions, changes, etc.
n. 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.
d. Does your system provide automatic logout based on keyboard or mouse inactivity?
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-LIMS 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.

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 allows a user to independently add fields without requiring reconfiguration of the system, even after routine upgrades and maintenance.
h. The system allows a user to independently add 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.
i. The system supports the definition and maintenance of edit tables and lists.
j. The system dynamically changes captions (labels) on system fields.
k. The system has dynamically configurable limit periods and notification hierarchy.
l. 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 sample 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 supports the modification of specimen or specimen batch information prior to actual multi-sample (batch) login.
h. The system supports ad-hoc specimens not predefined in the specimen point list during multi-sample (batch) login.
i. The system creates, saves, and recalls pre-login groups for routine samples to simplify recurring logins.
j. The system streamlines the login of recurring sample projects.
k. The system automatically generates labels for recurring samples and sample groups.
l. The system allows authorized users to generate user-definable or rules-based chain of custodies, worksheets, routing sheets, and custom labels upon sample login.
m. The 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. The system includes environmental monitoring (EM) functionality or integrates with an external EM product.
o. The system prevents a sample from being placed in a report queue until approved.
p. The system includes comprehensive scheduling, tracking, and flow management of samples, including across multiple sites.
q. The system is capable of geographically organizing sample records and their associated tests for special analysis and reporting.
r. The system allows authorized users to accept, cancel, re-run, and override attributes of one or multiple tests for a given sample.
s. The system allows authorized users to review the available test types in the system, including their reference range and units of measure.
t. The system has a "miscellaneous" test code to allow a test undefined in the system to be ordered and billed.
u. The system allows authorized users to schedule routine samples on an hourly, daily, weekly, or monthly basis, allowing them to be enabled and disabled as a group.
v. The system generates an hourly, daily, weekly, or monthly sample collection schedule from a scheduling database.
w. The system schedules and assign tasks based on available inventory and personnel.
x. The system supports automatic assignment and scheduling of analysis requests.
y. The system receives accession/analysis request information from web-enabled forms.
z. The system electronically receives and processes collection and analysis request information and schedules from third parties.
aa. The system has an inter-lab transfer function.
ab. The system processes automated uploading of field-derived sample collection data.
ac. The system allows users to handle billable and non-billable tests on the same accession.
ad. 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. Does your system support 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? Please give details.
b. Does your system provide normal data range values for diagnostic tests?
c. Does your system includes default input values for diagnostic tests?
d. Does your system provide for a single test code requiring multiple analytes as targets?
e. Does your system limit test code authorization to only qualified personnel and maintain their certification(s) to run assigned tests?
f. Does your system support and qualify text-based tests?
g. Does your system support single-component tests such as pH, BOD, CD, etc.?
h. Does your system allow users to specify a single-component, multi-component, or narrative text test or group of tests, which represent all tests required?
i. Does your system permit user-generated and modifiable calculations (based on a formulaic language) to be applied to all tests?
j. Does your system distinguish between routine and duplicate analysis?
k. Does your system provide an overview of all outstanding tests/analyses for better coordination of work schedules?
l. Does your system notify analysts of applicable safety hazards associated with a sample, reagent, or test before testing begins?
m. Does your system electronically transfer an item during testing from one functional area to another?
n. Does your system's user interface display visual indicators such as status icons to indicate a sample's status in the workflow?
o. Does your system allow file transfer of data from instruments via intelligent interfaces or multi-sample/multi-test ASCII files, with full on-screen review prior to database commitment?
p. Does your system permit manual data entry into an electronic worksheet of test measurements and results?
q. Does your system allow incorrectly inputted data to be manually corrected?
r. Does your system provide 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?
s. Does your system allow automated or semi-automated data insertion?
t. Does your system store 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. Does your system update sample/item status when tests are completed?
b. Can your system automatically reorder a test or order additional tests if results don't meet lab-defined criteria?
c. Does your system read results from previously entered tests to calculate a final result and immediately display the calculated result?
d. Does your system allow authorized users to review all analytical results, including pricing, spec violations, history or trend analysis by analyte, and comments?
e. Can your system graphically display 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. Does your system allow 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. Does your system display the standard operating procedure (SOP) associated with each test result to ensure proper techniques were used?
h. Does your system store test-related analysis comments with the test?
i. Does your system provide auto-commenting for common laboratory result comments?
j. Does your system provide 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?
k. Does your system's results validation process access all information about a sample or group of samples, including comments or special information about the sample?
l. Does your system's results validation process check each result against its individual sample location specifications (both warning and specification limits)?
m. Does your system support validation at the analysis and sample level, while also prohibiting sample validation when analysis validation is incomplete?
n. Does your system use a menu-driven process for results validation?
o. Does your system provide secure electronic peer review of results?
p. Can your system clearly differentiate released preliminary data from fully validated results?
q. Does your system validate/approve data prior to being moved to the main database?
r. Does your system fully manage all aspects of laboratory quality control, including the reporting and charting of all quality control data captured in the lab? Please explain how.
s. Does your system provide a base for a quality assurance program, including proficiency testing, scheduled maintenance of equipment, etc.? Please explain how.
t. Does your system distinguish QA/QC duplicates from normal samples?
u. Does your system allow QA/QC tests to be easily created and associated with the primary analytical test?
v. Does your system allow manual entry of QA and QC data not captured as part of the system's regular processes?
w. Does your system calculate monthly QA/QC percentages for testing?
x. Does your system automatically flag out-of-range quality control limits?
y. Does your system check 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. Does your system bilaterally interface with instruments and related software? If so, please provide details.
b. Can your system download data directly from laboratory instruments?
c. Does your system permit the defining and exporting of sequences to instruments?
d. Does your system track and report on laboratory equipment usage?
e. Does your system allow automatic or manual reservation/scheduling of laboratory instruments?
f. Does your system automatically (or manually allow an authorized user to) remove an instrument from potential use when it falls out of tolerance limit or requires scheduled calibration?
g. Does your system provide a database of preventative maintenance, calibration, and repair records for laboratory equipment, preferably supported by standardized reporting?
h. Can your system schedule calibration, verification, and maintenance tasks in the worksheets or work flow process and make that schedule available for viewing?
i. Does your system allow 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. Does your system support a library of common and/or basic electronic data deliverable (EDD) formats? If so, which?
b. Can your system transfer data to and from another record management system? If so, how?
c. Does your system integrate with Microsoft Exchange services?
d. Can your system import data from and export data to Microsoft Word, Excel, and/or Access?
e. Can your system interface with non-Microsoft programs? If so, which?
f. Can your system interface with external billing systems? If so, how?
g. Can your system interface with enterprise resource planning (ERP) systems? If so, how?
h. Can your system interface with external contract or reference laboratories to electronically send or retrieve datasheets, analysis reports, and other related information?
i. Can your system exchange data with National Identification System (NAIS) tracking systems?
j. Can your system generate and exchange data with other systems using Health Level 7 (HL7) standards?
k. Can your system leverage the application programming interface (API) of other systems to establish integration between systems?
l. Does your system provide a real-time interface for viewing live and stored data transactions and errors generated by interfaced instruments and systems?
m. Can your system transmit status changes of samples, inventory, equipment, etc. to an external system?
n. Can your system direct output from ad-hoc queries to a computer file for subsequent analysis by other software?
o. Does your system support the manual retransmission of data to interfaced systems?
p. Does your system support dockable mobile devices and handle information exchange between them and the system?
q. Does your system support the use of optical character recognition (OCR) software?

1.4.8 Reporting

1.4.8 Reporting
Request for information	Requirement code	Vendor response
a. Does your system include a versatile report writer and forms generator that can generate reports from any data in tables? If so, please provide details.
b. Does your system include a custom graphic generator for forms?
c. Does your system interface with a third-party reporting application?
d. Does your system allow the development of custom templates for different types of reports?
e. Does your system maintain template versions and renditions, allowing management and tracking of the template over time?
f. Can your system generate template letters for semi-annual reports?
g. Does your system support report queries by fields/keys, status, completion, or other variables?
h. Does your system use Microsoft Office tools for formatting reports?
i. Does your system support multiple web browsers for viewing online reports? If so, list which ones.
j. Can your system generate, store, reproduce, and display laboratory, statistical, and inventory reports on demand, including narrative?
k. Does your system include 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?
l. Can your system indicate whether a report is preliminary, amended, corrected, or final while retaining revision history?
m. Does your system support both structured and synoptic reporting?
n. Can your system generate management and turn-around time reports and graphs?
o. Can your system generate customized final reports?
p. Can your system automatically generate laboratory reports of findings and other written documents?
q. Can your system automatically generate individual and aggregate workload and productivity reports on all operational and administrative activities?
r. Can your system automatically generate and transmit exception trails and exception reports for all entered and/or stored out-of-specification data?
s. Can your system generate a read-only progress report that allows for printed reports of sample status and data collected to date?
t. Does your system provide an ad-hoc web reporting interface to report on user-selected criteria?
u. Can your system automatically generate and update control charts?
v. Can your system generate QA/QC charts for all recovery, precision, and lab control samples via a full statistics package, including Levy-Jennings plots and Westgard multi-rule?
w. Does your system display history of previous results for an analyte's sample point in a tabular report, graphic trend chart, and statistical summary?
x. Can your system automatically generate and post periodic static summary reports on an internal web server?
y. Does your system 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? Please explain.
z. Does your system electronically transmit results via final report only when all case reviews have been completed by the case coordinator?
aa. Does your system include a rules engine to determine the recipients of reports and other documents based on definable parameters?
ab. Does your system allow database access using user-friendly report writing and inquiry tools?

1.4.9 Laboratory management

1.4.9 Laboratory management
Request for information	Requirement code	Vendor response
a. Does your system allow the creation, modification, and duplication of user profiles?
b. Does your system allow entry, maintenance, and administration of customers, suppliers, and other outside entities?
c. Does your system allow the creation, modification, and maintenance of user training records and associated training materials?
d. Does your system allow the management of information workflow, including notifications for requests and exigencies?
e. Does your system allow the management of documents like SOPs, MSDS, etc. to better ensure they are current and traceable?
f. Does your system allow the management and monitoring of resources by analyst, priority, analysis, and instrument?
g. Does your system allow authorized persons to select and assign tasks by analysts, work group, instrument, test, sample, and priority?
h. Does your system allow authorized persons to review unassigned work by discipline and by lab?
i. Does your system allow authorized persons to review pending work by analyst prior to assigning additional work?
j. Does your system manage and report on reference samples, reagents, and other inventory, including by department? If so, to what extent?
k. Does your system automatically warn specified users when inventory counts reach a definable threshold and either prompt for or process a reorder?
l. Does your system allow authorized users to monitor and report on reference and reagent creation, use, and expiration?
m. Does your system allow authorized users to search invoice information by invoice number, account number, accession, payment types, client, or requested diagnostic test(s)?
n. Does your system include performance assessment tracking?
o. Can your system receive, record, and maintain customer and employee feedback and apply tools to track the investigation, resolution, and success of any necessary corrective action?
p. Does your system monitor proficiency test assignment, completion, and casework qualification for analytical staff?
q. Does your system provide analysis tools to better support laboratory functions like resource planning, productivity projections, workload distribution, and work scheduling? Do those tools display information in a consolidated view, with the ability to drill down to more detailed data? Please explain.
r. Does your system calculate administrative and lab costs?
s. Does your system capture and maintain patient, submitter, supplier, and other client demographics and billing information for costing, invoicing, collecting, reporting, and other billing activities?
t. Does your system support multiple customer payment sources (e.g. grants}? Please explain the extent.
u. Does your system track number of visits per specific industry?