1.2.1 General IT
1.2.1 General IT
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Requirement code
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Vendor response
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a. The system operates with a traditional client-server architecture, with software installed on each machine that needs to access the system.
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b. The system operates with a web-based interface, hosted on a server and accessed via a web browser on most any machine.
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c. The system contains a single, centralized database that supports multiple sites and departments.
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d. The system's database conforms to the Open Database Connectivity Standard (ODBC).
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e. The system is designed so upgrades to the back-end database do not require extensive reconfiguration or effectively cripple the system.
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f. The system is designed to not be impacted by multiple users or failover processes.
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g. The system applies security features to all system files.
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h. The system applies log-in security to all servers and workstations accessing it.
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i. The system provides a workstation and server authentication mechanism.
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j. The system applies Secured Socket Layer (SSL) encryption on the web client interface.
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k. The system encrypts client passwords in a database, with support for multi-case and special characters.
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l. The system uses TCP/IP as its network transport.
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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.
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n. The system allows automated backup and restore capability without support intervention, as well as manual backups.
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o. The system maintains the transactional history of system administrators.
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p. The system maintains an analyst communication log, accessible by the administrator.
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1.2.2 Hardware environment
1.2.2 Hardware environment
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Requirement code
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Vendor response
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a. The system proves compatible with a variety of hardware environments.
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b. The system can be utilized with a touch-screen.
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1.2.3 Software environment
1.2.3 Software environment
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Requirement code
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Vendor response
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a. The system proves compatible with a variety of software environments.
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b. The system utilizes a non-proprietary database such as Oracle or Microsoft SQL Server.
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1.3 Regulatory compliance and security
1.3.1 Regulatory compliance
1.3.1 Regulatory compliance
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Request for information
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Requirement code
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Vendor response
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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.
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b. The system supports ISO/IEC 17025 requirements.
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c. The system supports HIPAA requirements.
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d. The system supports GALP and/or GAMP standards.
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e. The system supports the standards of The NELAC Institute.
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f. The system meets government requirements for handling classified information and documents.
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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.
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h. The system maintains audit trails at least as long as the records to which they pertain.
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i. The system's audit log retains all data, prohibits any deletions, allows user comments, and allows reporting of contained information.
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j. The system provides additional persistent auditing capabilities, such as the audit of cancelled tests and scheduled system functions.
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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.
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l. The system provides the ability to insert/manage secure electronic and/or digital signatures.
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m. The system incorporates automatic date and time stamping of additions, changes, etc.
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n. The system can automatically validate and approve data prior to being moved to the main database.
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1.3.2 Security
1.3.2 Security
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Request for information
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Requirement code
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Vendor response
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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.
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b. The system allows administrators and users to reset user passwords.
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c. The system features and enforces adjustable rules concerning password complexity, reuse, and expiration.
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d. The system can lock a user out after a specified number of consecutive failed log-in attempts.
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d. Does your system provide automatic logout based on keyboard or mouse inactivity?
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e. The system provides the option for automatic user logout based on keyboard or mouse inactivity.
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f. The system makes authority checks to ensure only authorized individuals can use the system to perform an operation.
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g. The system allows authorized users to modify records, while also maintaining an audit trail of such actions.
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h. The system allows authorized users to manually delete records, while also maintaining an audit trail of such actions.
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i. The system prompts users to declare a reason for making changes to or deleting data in the system.
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j. The system provides email notification of lockout, security access, and improper workstation access.
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k. The system provides a mechanism to allow a user read-only access to stored data.
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l. The system allows authorized users to generate a detailed user access record.
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m. The system allows authorized users to review audit logs at will.
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n. The system allows authorized users to query and print chain of custody for items, cases, projects, and batches.
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o. The system allows supervisors to override chain of custody.
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p. The system automatically tracks when supervisors review critical result values.
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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.
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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.
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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.
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t. The system employs automatic file encryption on stored data.
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u. The system employs checks to enforce permitted sequencing of steps and events.
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v. The system allows multiple users to connect simultaneously to a contract lab.
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w. The system provides read-only access to contract laboratory results.
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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.
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1.4 General system functions
1.4.1 General functions
1.4.1 General functions
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Request for information
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Requirement code
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Vendor response
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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.
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b. The system allows authorized users to configure their GUI to a specific language, character set, and time zone.
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c. The system permits remote access for users, system admins, and support agents.
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d. The system allows for the use of navigation keys to freely move from field to field.
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e. The system allows tabular data to be sorted and filtered.
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f. The system can send on-screen output to a printer or file without contradicting view-only statuses.
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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.
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h. The system eliminates (or significantly reduces) redundant data entry and paper trails.
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i. The system contains one or more spell-check dictionaries that allow authorized users to add, edit, or remove entries.
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j. The system provides full database keyword and field search capability, including the use of multiple search criteria.
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k. The system includes the ability to search multiple databases, including those containing legacy data.
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l. The system allows users to build, save, and edit queries for future use.
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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.
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n. The system cleanly converts migrated data to allow for reporting of historical specimen collections.
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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.
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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.
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q. The system can manage and store media objects like digital photos, bitmaps, movies, and audio files.
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r. The system issues sequential numbers for chain of custody.
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s. The system's numbering scheme allows for sub-numbering while maintaining parent-child relationships.
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t. The system efficiently utilizes standardized data input points and enhanced individual workload tracking.
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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.
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v. The system can link objects to other objects, e.g. linking a standard operating procedure (SOP) to a test result.
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w. The system notifies users of events like the scheduling, receipt, and completion of tasks.
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x. The system includes the ability to set up alerts via email.
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y. The system has real-time messaging capabilities, including instant messaging to one or more users.
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z. The system supports the use of a voice recognition system (for navigation or transcription) or has that functionality.
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aa. The system offers integrated or online user help screens.
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1.4.2 Configuration and customization
1.4.2 Configuration and customization
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Requirement code
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Vendor response
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a. The system can be configured to meet the workflow of a laboratory without additional programming.
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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.
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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.
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d. The system can expand to accommodate a new discipline.
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e. The system supports customized screens with user-definable information specific to a customer, department, analysis, etc.
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f. The system allows the administrator to create custom screens, applications, and reports.
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g. The system allows a user to independently add fields without requiring reconfiguration of the system, even after routine upgrades and maintenance.
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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.
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i. The system supports the definition and maintenance of edit tables and lists.
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j. The system dynamically changes captions (labels) on system fields.
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k. The system has dynamically configurable limit periods and notification hierarchy.
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l. The system allows for the integration of additional printers and scanners both locally and externally.
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1.4.3 Receiving and scheduling
1.4.3 Receiving and scheduling
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Request for information
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Requirement code
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Vendor response
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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.
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b. The system supports barcoded specimen labeling and tracking.
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c. The system allows users to create, manage, and track viewable sample container schemata.
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d. The system creates and maintains a unique electronic accession record for each accession received.
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e. The system supports standard-format digital picture and document upload and attachment to electronic accession records.
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f. The system supports a user-configurable, spreadsheet-style, templated multi-specimen (batch) login without requiring additional programming.
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g. The system supports the modification of specimen or specimen batch information prior to actual multi-sample (batch) login.
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h. The system supports ad-hoc specimens not predefined in the specimen point list during multi-sample (batch) login.
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i. The system creates, saves, and recalls pre-login groups for routine samples to simplify recurring logins.
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j. The system streamlines the login of recurring sample projects.
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k. The system automatically generates labels for recurring samples and sample groups.
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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.
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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.
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n. The system includes environmental monitoring (EM) functionality or integrates with an external EM product.
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o. The system prevents a sample from being placed in a report queue until approved.
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p. The system includes comprehensive scheduling, tracking, and flow management of samples, including across multiple sites.
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q. The system is capable of geographically organizing sample records and their associated tests for special analysis and reporting.
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r. The system allows authorized users to accept, cancel, re-run, and override attributes of one or multiple tests for a given sample.
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s. The system allows authorized users to review the available test types in the system, including their reference range and units of measure.
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t. The system has a "miscellaneous" test code to allow a test undefined in the system to be ordered and billed.
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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.
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v. The system generates an hourly, daily, weekly, or monthly sample collection schedule from a scheduling database.
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w. The system schedules and assign tasks based on available inventory and personnel.
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x. The system supports automatic assignment and scheduling of analysis requests.
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y. The system receives accession/analysis request information from web-enabled forms.
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z. The system electronically receives and processes collection and analysis request information and schedules from third parties.
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aa. The system has an inter-lab transfer function.
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ab. The system processes automated uploading of field-derived sample collection data.
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ac. The system allows users to handle billable and non-billable tests on the same accession.
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ad. The system supports tracking of shipping and receiving.
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1.4.4 Analysis and data entry
1.4.4 Analysis and data entry
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Request for information
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Requirement code
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Vendor response
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a. The system supports a variety of test protocols, each capable of storing test comments, test required, and special information like GCMS conditions or special objects associated with the test.
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b. The system provides and enforces normal data range values for diagnostic tests.
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c. The system includes default input values for diagnostic tests.
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d. The system provides for a single test code requiring multiple analytes as targets.
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e. The system allows authorized users to make a test code inactive across one or more sites while retaining it for audit and reporting purposes.
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f. The system limits test code authorization to only qualified personnel and maintains their certification(s) to run assigned tests.
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g. The system supports and qualifies text-based tests.
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h. The system supports single-component tests such as pH, BOD, CD, etc.
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i. The system allows users to specify a single-component, multi-component, or narrative text test or group of tests, which represent all tests required.
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j. The system can effectively manage complex molecular testing protocols.
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k. The system can effectively manage genetic testing protocols.
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l. The system permits user-generated and modifiable calculations (based on a formulaic language) to be applied to all tests.
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m. The system distinguishes between routine and duplicate analysis.
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n. The system provides an overview of all outstanding tests/analyses for better coordination of work schedules.
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o. The system notifies analysts of applicable safety hazards associated with a sample, reagent, or test before testing begins.
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p. The system electronically transfers an item during testing from one functional area to another.
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q. The system's user interface displays visual indicators such as status icons to indicate a sample's status in the workflow.
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r. The system allows file transfer of data from instruments via intelligent interfaces or multi-specimen/multi-test ASCII files, with full on-screen review prior to database commitment.
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s. The system permits manual data entry into an electronic worksheet of test measurements and results.
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t. The system allows incorrectly inputted data to be manually corrected.
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u. The system prevents out-of-range and other critical results from being posted as final.
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v. The 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.
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w. The system allows automated or semi-automated data insertion.
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x. The system stores non-narrative textual results in searchable fields.
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1.4.5 Post-analysis and validation
1.4.5 Post-analysis and validation
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Request for information
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Requirement code
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Vendor response
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a. The system updates sample/item status when tests are completed.
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b. The system automatically reorders a test or orders additional tests if results don't meet lab-defined criteria, especially when the original sample is still available.
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c. The system reads results from previously entered tests to calculate a final result and immediately displays the calculated result.
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d. The system allows authorized users to review all analytical results, including pricing, spec violations, history or trend analysis by analyte, and comments.
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e. The system graphically displays the results of one or more tests in a graph (normalized or otherwise) for the purpose of visualizing data or searching for possible trends.
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f. The system allows on-screen review of the stored test result, diluted result with corrected method detection limits (MDLs), and qualifiers after running samples for multiple dilutions as in gas chromatography–mass spectrometry (GC-MS).
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g. The system includes data mining tools for model learning, evaluation, and usage.
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h. The system displays the standard operating procedure (SOP) associated with each test result to ensure proper techniques were used.
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i. The system stores test-related analysis comments with the test.
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j. The system provides auto-commenting for common laboratory result comments.
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k. The system is capable of displaying entered order and test comments as an onscreen alert for testing and other personnel.
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l. The system provides for high-volume multi-component transfers of test results, with the ability to automatically match samples to data files in either a backlog mode or a designated file mode, to parse the data, and to review and commit the sample data.
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m. The system's results validation process accesses all information about a sample or group of samples, including comments or special information about the sample.
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n. The system's results validation process checks each result against its individual sample location specifications (both warning and specification limits).
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o. The system supports validation at the analysis and sample level, while also prohibiting sample validation when analysis validation is incomplete.
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p. The system uses a menu-driven process for results validation.
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q. The system provides secure electronic peer review of results.
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r. The system clearly differentiates released preliminary data from fully validated results.
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s. The system validates/approves data prior to being moved to the main database.
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t. The system can hold all test results on a sample with multiple tests ordered on it until all work is completed and a final report is issued.
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u. The system fully manages all aspects of laboratory quality control, including the reporting and charting of all quality control data captured in the lab.
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v. The system provides a base for a quality assurance program, including proficiency testing, scheduled maintenance of equipment, etc.
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w. The system distinguishes QA/QC duplicates from normal samples.
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x. The system allows QA/QC tests to be easily created and associated with the primary analytical test.
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y. The system allows manual entry of QA and QC data not captured as part of the system's regular processes.
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z. The system calculates monthly QA/QC percentages for testing.
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aa. The system automatically flags out-of-range quality control limits.
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ab. The system is able to flag results for aspects other than being out-of-range, including testing location, test subject age, etc.
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ac. The system checks data files for specification and corrects them for specific reporting and analyte limits and qualifiers like dilution factor, automatically assigning qualifiers based on project analyte limiting.
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1.4.6 Instruments
1.4.6 Instruments
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Request for information
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Requirement code
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Vendor response
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a. The system bilaterally interfaces with instruments and related software.
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b. The system downloads data directly from laboratory instruments.
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c. The system permits the defining and exporting of sequences to instruments.
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d. The system tracks and reports on the usage of attached laboratory instruments.
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e. The system allows automatic or manual reservation/scheduling of laboratory instruments.
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f. The system automatically (or manually allow an authorized user to) removes an instrument from potential use when it falls out of tolerance limit or requires scheduled calibration.
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g. The system provides a database of preventative maintenance, calibration, and repair records for laboratory equipment, preferably supported by standardized reporting.
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h. The system schedules calibration, verification, and maintenance tasks in the worksheets or work flow process and make that schedule available for viewing.
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i. The system allows users to create and edit instrument maintenance profiles.
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1.4.7 External system interfaces
1.4.7 External system interfaces
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Request for information
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Requirement code
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Vendor response
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a. The system supports a library of common electronic data deliverable (EDD) formats.
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b. The system transfers data to and from another record management system.
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c. The system integrates with Microsoft Exchange services.
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d. The system imports data from and exports data to Microsoft Word, Excel, and/or Access.
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e. The system can interface with non-Microsoft programs.
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f. The system interfaces with external billing systems.
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g. The system interfaces with enterprise resource planning (ERP) systems.
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h. The system interfaces with external contract or reference laboratories to electronically send or retrieve datasheets, analysis reports, and other related information.
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i. The system exchanges data with National Identification System (NAIS) tracking systems.
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j. The system generates and exchanges data with other systems using Health Level 7 (HL7) standards.
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k. The system leverages the application programming interface (API) of other systems to establish integration between systems.
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l. The system provides a real-time interface for viewing live and stored data transactions and errors generated by interfaced instruments and systems.
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m. The system transmits status changes of specimens, inventory, equipment, etc. to an external system.
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n. The system directs output from ad-hoc queries to a computer file for subsequent analysis by other software.
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o. The system supports the manual retransmission of data to interfaced systems.
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p. The system supports dockable mobile devices and handle information exchange between them and the system.
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q. The system supports the use of optical character recognition (OCR) software.
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1.4.8 Reporting
1.4.8 Reporting
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Request for information
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Requirement code
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Vendor response
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a. The system includes a versatile report writer and forms generator that can generate reports from any data in tables.
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b. The system includes a custom graphic generator for forms.
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c. The system interfaces with a third-party reporting application.
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d. The system allows the development of custom templates for different types of reports.
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e. The system maintains template versions and renditions, allowing management and tracking of the template over time.
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f. The system generates template letters for semi-annual reports.
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g. The system supports report queries by fields/keys, status, completion, or other variables.
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h. The system use Microsoft Office tools for formatting reports.
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i. The system supports multiple web browsers for viewing online reports.
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j. The system generates, stores, reproduces, and displays laboratory, statistical, and inventory reports on demand, including narrative.
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k. The system includes several standard reports and query routines to access all specimens with the pending status through a backlog report that includes the following criteria: all laboratory, department, analysis, submission date, collection date, prep test complete, location, project, specimen delivery group, and other user-selectable options.
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l. The system indicates whether a report is preliminary, amended, corrected, or final while retaining revision history.
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m. The system supports both structured and synoptic reporting.
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n. The system generates management and turn-around time reports and graphs.
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o. The system generates customized final reports.
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p. The system automatically generates laboratory reports of findings and other written documents.
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q. The system automatically generates individual and aggregate workload and productivity reports on all operational and administrative activities.
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r. The system automatically generates and transmits exception trails and exception reports for all entered and/or stored out-of-specification data.
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s. The system generates a read-only progress report that allows for printed reports of specimen status and data collected to date.
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t. The system provides an ad-hoc web reporting interface to report on user-selected criteria.
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u. The system automatically generates and updates control charts.
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v. The system generates QA/QC charts for all recovery, precision, and lab control specimens via a full statistics package, including Levy-Jennings plots and Westgard multi-rule.
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w. The system displays history of previous results for an analyte's specimen point in a tabular report, graphic trend chart, and statistical summary.
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x. The system automatically generates and posts periodic static summary reports on an internal web server.
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y. The system transmits results in a variety of ways including fax, e-mail, print, and website in formats like RTF, PDF, HTML, XML, DOC, XLS, and TXT.
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z. The system electronically transmits results via final report only when all case reviews have been completed by the case coordinator.
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aa. The system includes a rules engine to determine the recipients of reports and other documents based on definable parameters.
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ab. The system allows database access using user-friendly report writing and inquiry tools.
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1.4.9 Laboratory management
1.4.9 Laboratory management
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Request for information
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Requirement code
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Vendor response
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a. The system allows the creation, modification, and duplication of user profiles.
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b. The system allows entry, maintenance, and administration of customers, suppliers, and other outside entities.
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c. The system allows customers, suppliers, and other such entities to be flagged as either active or inactive.
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d. The system allows the creation, modification, and maintenance of user training records and associated training materials.
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e. The system supports the ability to set up separate security, inventory, reporting, etc. profiles across multiple facilities.
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f. The system allows the management of information workflow, including notifications for requests and exigencies.
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g. The system allows the management of documents like SOPs, MSDS, etc. to better ensure they are current and traceable.
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h. The system allows the management and monitoring of resources by analyst, priority, analysis, and instrument.
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i. The system allows authorized persons to select and assign tasks by analysts, work group, instrument, test, sample, and priority.
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j. The system allows authorized persons to review unassigned work by discipline and by lab.
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k. The system allows authorized persons to review pending work by analyst prior to assigning additional work.
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l. The system manages and reports on reference samples, reagents, and other inventory, including by department.
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m. The system automatically warns specified users when inventory counts reach a definable threshold and either prompt for or process a reorder.
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n. The system allows authorized users to monitor and report on reference and reagent creation, use, and expiration.
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o. The system allows authorized users to search invoice information by invoice number, account number, accession, payment types, client, or requested diagnostic test(s).
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p. The system includes performance assessment tracking.
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q. The system receives, records, and maintains customer and employee feedback and applies tools to track the investigation, resolution, and success of any necessary corrective action.
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r. The system includes an incident tracking system for recording, investigating, and managing safety and accident violations in the laboratory.
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s. The system monitors proficiency test assignment, completion, and casework qualification for analytical staff.
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t. The system includes revenue management functionality, including profitability analysis.
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u. The system provides analysis tools to better support laboratory functions like resource planning, productivity projections, workload distribution, and work scheduling, and those tools display information in a consolidated view, with the ability to drill down to more detailed data.
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v. The system calculates administrative and lab costs.
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w. The system captures and maintains patient, submitter, supplier, and other client demographics and billing information for costing, invoicing, collecting, reporting, and other billing activities.
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x. The system supports multiple customer payment sources (e.g. grants).
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y. The system tracks number of visits per specific industry.
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1.5 System-specific
The system-specific addendum can be found here.
1.6 Industry-specific
The industry-specific addendum can be found here.
1.7 Custom requirements
1.7 Custom requirements
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Request for information
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Requirement code
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Vendor response
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a.
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b.
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c.
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d.
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e.
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f.
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g.
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h.
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i.
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h.
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i.
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j.
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