User:Shawndouglas/sandbox

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System questionnaire

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 lists the extensive requirements of a laboratory information management system as well as other laboratory informatics systems. 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."

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.

To add the requirement code and vendor notes to a functionality item, look for this kind of code in the appropriate section:

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...and add the applicable requirement code after the pipe (|) on the second line, and the vendor response after the pipe (|) on the third line.

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. 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 well-documented system upgrades that authorized users can independently install?
s. Does the vendor provide source code for the system?
t. Does the vendor provide an optional comprehensive set of test codes suitable for use by the purchasing facility?

1.2 Information technology

1.2.1 General IT

1.2.1 General IT
Request for information	Requirement code	Vendor response
a. Does your system operate with a web-based interface (hosted on a server and accessed via a web browser) or on a more traditional client-server architecture? If web-based, what technology does it support?
b. Does your system contain a single database that supports multiple laboratory sites and departments?
c. Does your system's database conform to the Open Database Connectivity Standard (ODBC)?
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 backup and restore capability without support intervention?
o. Does your system maintain the transactional history of system administrators?
p. Does your system architecture facilitate the incorporation of new technology and interfaces?

1.2.2 Hardware environment

1.2.2 Hardware environment
Request for information	Requirement code	Vendor response
a. Does your system prove compatible with a variety of hardware environments? Please describe how.

1.2.3 Software environment

1.2.3 Software environment
Request for information	Requirement code	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 and security

1.3.1 Regulatory compliance

1.3.1 Regulatory compliance
Request for information	Requirement code	Vendor response
a. Does your system support 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? Please explain in detail.
b. Does your system support ISO/IEC 17025 requirements? Please explain how.
c. Does your system support HIPAA requirements? Please explain how.
d. Does your system support GALP and/or GAMP standards? Please explain how.
e. Does your system support the standards The NELAC Institute? Please explain how.
f. Does your system meet government requirements for handling classified information and documents?
g. Does your system maintain audit and specification violation trails of all data manipulation — such as result and header information changes — as consistent with all applicable regulations and standards? Provide details.
h. Does your system's audit log retain all data, prohibit any deletions, and allows user comments?
i. Does your system provide additional persistent auditing capabilities? If so, what?
j. Does your system provide user-selectable NELAP-compliant internal chain of custody that tracks all samples and associated containers from the time they are collected until disposed of? Please explain how.
k. Does your system provide the ability to insert/manage secure electronic and/or digital signatures?
l. Does your system incorporate automatic date and time stamping of additions, changes, etc.?

1.3.2 Security

1.3.2 Security
Request for information	Requirement code	Vendor response
a. Does your system allow system administrators and managers to configure multiple levels of user rights and security by site location, department, role, and/or specific function? Please explain the depth of this security.
b. Does your system allow administrators to reset user passwords?
c. Does your system enforce rules concerning password complexity, reuse, and expiration? If so, how?
d. Does your system provide automatic logout based on keyboard or mouse inactivity?
e. Does your system prompt users for a reason for database record changes?
f. Does your system allow administrators to modify records, while also maintaining an audit trail of such actions?
g. Does your system allow authorized personnel to review audit logs at will?
h. Does your system allow authorized users to query and print chain of custody for items, cases, projects, and batches?
i. Does your system allow supervisors to override chain of custody?
j. Does your system provide email notification of lockout, security access, and improper workstation access?
k. Does your system allow multiple users to connect simultaneously to a contract lab?
l. Does your system provide read-only access to contract laboratory results?
m. Does your system prohibit issuing reports outside of qualified areas while also allowing reports to be viewed locally or remotely based on security application limits and/or sample ownership? If so, how?

1.4 General system functions

1.4.1 General functions

1.4.1 General functions
Request for information	Requirement code	Vendor response
a. Does your system offer 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 sample points, projects, and user-defined queries, and can be configured to language, character set, and time zone needs?
b. Does your system permit remote access for users, system admins, and support agents?
c. Does your system allow for the use of navigation keys to freely move from field to field?
d. Does your system allow data tables to be sorted?
e. Can your system send on-screen output to a printer or file? If so, does it contradict view-only statuses?
f. Does your system provide single data entry, automatically populate other data fields, and remember pertinent and relevant data so it doesn't need to be re-entered, selected, or searched for?
g. Does your system support multiple users entering data simultaneously?
h. Does your system eliminate (or significantly reduce) redundant data entry and paper trails? If so, how?
i. Does your system contain one or more spell-check dictionaries that allow authorized users to add, edit, or remove entries?
j. Does your system provide full database keyword and field search capability, including the use of multiple search criteria?
k. Does your system include the ability to search multiple databases, including those containing legacy data?
l. Does your system interface with or import existing data from other systems and/or databases?
m. Does you system cleanly convert migrated data to allow for reporting of historical sample collections? If so, how?
n. Does your system provide data archival and retention functionality for both paper-based and electronic laboratory records? If so, what is your system strategy for maintaining the archives as technology changes?
o. Does your system allow users to associate and store both sample- and non-sample-related objects such as pictures from microscopes, GCMS scans of peaks, PDF files, spreadsheets, or even raw data files from instrument runs for later processing?
p. Does your system store more non-traditional information and objects like project- or sample-specific special information fields, user-defined fields, scanned chain of custodies and digital photos of such items as sample events, bitmaps, movies, and .wav audio files?
q. Does your system issue sequential numbers for chain of custody?
r. Does your system's numbering scheme allow for sub-numbering while maintaining parent-child relationships?
s. Does your system efficiently utilize standardized data input points and enhanced individual workload tracking?
t. Does your system capture data from all laboratory processes, ensuring uniformity of statistical reporting and other electronic data shared with designated users of the data?
u. Does your system link or embed standard operation procedures (SOPs) to/in other objects like analysis requests and test results?
v. Does your system notify users of events like the scheduling, receipt, and completion of tasks?
w. Does your system include the ability to set up alerts via email?
x. Does your system maintain an analyst communication log?

1.4.2 Configuration and customization

1.4.2 Configuration and customization
Request for information	Requirement code	Vendor response
a. Can your system can be configured to meet the workflow of a laboratory without additional programming? Please explain how.
b. Can your system easily and efficiently be modified to meet lab growth and changing business needs? Please explain how.
c. Does your system include an application programming interface (API)? If so, what kind? If web, does it use Simple Object Access Protocol (SOAP) or representational state transfer (REST)?
d. Can your system expand to accommodate a new discipline? If so, how?
e. Can your system support customized screens with user-definable information specific to a customer, department, analysis, etc.?
f. Does your system allow the administrator to create custom screens, applications, and reports? Please give details.
g. Does the system allow a user to independently add fields without requiring reconfiguration of the system, even after routine upgrades and maintenance?
h. Does your system allow 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. Does your system support the definition and maintenance of edit tables and lists?
j. Does your system dynamically change captions (labels) on system fields?
k. Does your system have dynamically configurable limit periods and notification hierarchy?
l. Does your system allow 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. Does your system track 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. Does your system support barcoded specimen labeling and tracking?
c. Does your system create and maintain a unique electronic accession record for each accession received?
d. Does your system support standard-format digital picture and document upload and attachment to electronic accession records?
e. Does your system support a user-configurable, spreadsheet-style, templated multi-sample (batch) login without requiring additional programming?
f. Does your system support the modification of sample or sample batch information prior to actual multi-sample (batch) login?
g. Does your system support ad-hoc samples not predefined in the sample point list during multi-sample (batch) login?
h. Does your system create, save, and recall pre-login groups for routine samples to simplify recurring logins?
i. Does your system streamline the login of recurring sampling projects?
j. Does your system automatically generate labels for recurring samples and sample groups?
k. Does your system allow authorized users to generate user-definable chain of custodies, worksheets, routing sheets, and custom labels upon sample login?
l. Does your system provide 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?
m. Does your system include environmental monitoring (EM) functionality or integrate with an external EM product?
n. Does your system prevent a sample from being placed in a report queue until approved?
o. Does your system include comprehensive sample scheduling, tracking, and sample flow management?
p. Does your system allow authorized users to schedule routine samples on an hourly, daily, weekly, or monthly basis, allowing them to be enabled and disabled as a group?
q. Does your system generate an hourly, daily, weekly, or monthly sampling schedule from a schedule database?
r. Does your system schedule and assign tasks based on available inventory and personnel?
s. Does your system support automatic assignment and scheduling of analysis requests?
t. Can your system receive accession/analysis request information from web-enabled forms?
u. Can your system electronically receive and process collection and analysis request information and schedules from third parties?
v. Does your system have an inter-lab transfer function?
w. Can your system process automated uploading of field-derived sample collection data?
x. Does your system allows users to handle billable and non-billable tests on the same accession?
y. Does your system support 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. Does your system read results from previously entered tests to calculate a final result and immediately display the calculated result?
c. Does your system allow authorized users to review all analytical results, including pricing, spec violations, history or trend analysis by analyte, and comments?
d. 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)?
e. Does your system display the standard operating procedure (SOP) associated with each test result to ensure proper techniques were used?
f. Does your system store test-related analysis comments with the test?
g. Does your system provide auto-commenting for common laboratory result comments?
h. 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?
i. 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?
j. Does your system's results validation process check each result against its individual sample location specifications (both warning and specification limits)?
k. Does your system support validation at the analysis and sample level, while also prohibiting sample validation when analysis validation is incomplete?
l. Does your system use a menu-driven process for results validation?
m. Does your system provide secure electronic peer review of results?
n. Can your system clearly differentiate released preliminary data from fully validated results?
o. Does your system validate/approve data prior to being moved to the main database?
p. 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.
q. Does your system provide a base for a quality assurance program, including proficiency testing, scheduled maintenance of equipment, etc.? Please explain how.
r. Does your system distinguish QA/QC duplicates from normal samples?
s. Does your system allow QA/QC tests to be easily created and associated with the primary analytical test?
t. Does your system allow manual entry of QA and QC data not captured as part of the system's regular processes?
u. Does your system calculate monthly QA/QC percentages for testing?
v. Does your system automatically flag out-of-range quality control limits?
w. 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 tasks in the worksheets or work flow process?

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 contract laboratories to electronically retrieve datasheets, sample analysis, 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. Can your system transmit status changes of samples, inventory, equipment, etc. to an external system?
m. Can your system direct output from ad-hoc queries to a computer file for subsequent analysis by other software?
n. Does your system support dockable mobile devices and handle information exchange between them and the system?

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?
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? 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 for laboratory operations to better support resource planning, productivity projections, workload distribution, and work scheduling?
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?