Difference between revisions of "LII:LIMS and laboratory informatics questionnaire"

From LIMSWiki
Jump to navigationJump to search
m (→‎Printing or saving: Added PDF notice)
(39 intermediate revisions by the same user not shown)
Line 43: Line 43:
{|  
{|  
  | STYLE="vertical-align:top;"|
  | STYLE="vertical-align:top;"|
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0" width="800px"
  |-
  |-
   ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px; width:800px;"| 1.0 '''Vendor information'''
   ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px; width:800px;"| 1.0 '''Vendor information'''
Line 73: Line 73:
|}
|}
|}
|}
==1.1 Vendor services==
==1.1 Vendor services==
{|  
{|  
Line 84: Line 85:
   ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
   ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
  |-  
  |-  
   | style="padding:5px; width:500px;" |'''a.''' Does the vendor offer an online demonstration and/or an on-site demonstration?
   | style="padding:5px; width:500px;" |'''a.''' The vendor offers an online and/or on-site demonstration.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-  
  |-  
   | style="padding:5px; width:500px;" |'''b.''' Does the vendor provide a detailed project approach and plan that includes the project team, timeline, deliverables, and risk and issue management procedures?
   | style="padding:5px; width:500px;" |'''b.''' The vendor provides a detailed project plan that includes the project team, timeline, deliverables, and risk and issue management procedures.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''c.''' Does the vendor explain their overall project approach, acknowledgement of the deliverables, time/schedule constraints, and any other criteria for the project?
   | style="padding:5px; width:500px;" |'''c.''' The vendor explains their overall project approach, deliverables, time constraints, and any other criteria for the project.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''d.''' Does the vendor provide reliable cost estimates and pricing schedules, including all products and services in the scope of work?
   | style="padding:5px; width:500px;" |'''d.''' The vendor provides reliable cost estimates and pricing schedules, including all products and services in the scope of work.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''e.''' Can the vendor detail the amount of time and staff that purchaser will have to provide for the implementation process?
   | style="padding:5px; width:500px;" |'''e.''' The vendor details the amount of time and staff that the purchaser will have to provide for the implementation process.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''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.
   | style="padding:5px; width:500px;" |'''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.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''g.''' Does the vendor provide a support schedule for the implementation process, including optional support levels and their function and availability? Give details.
   | style="padding:5px; width:500px;" |'''g.''' The vendor provides a support schedule for the implementation process, including optional support levels, their function, and availability.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''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?
   | style="padding:5px; width:500px;" |'''h.''' The vendor provides support during the "go-live" period between system validation/operational deployment and final acceptance/beginning of maintenance and support agreements.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''i.''' Does the vendor provide a gap analysis after initial system installation, identifying the deliverables or tasks remaining?
   | style="padding:5px; width:500px;" |'''i.''' The vendor provides a gap analysis after initial system installation, identifying the deliverables or tasks remaining.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''j.''' Does the vendor provide a table linking each deliverable to the corresponding user requirement specification it fulfills?
   | style="padding:5px; width:500px;" |'''j.''' The vendor provides a table linking each deliverable to the corresponding user requirement specification it fulfills.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''k.''' Does the vendor use a consistent training methodology for training new users? Give details.
   | style="padding:5px; width:500px;" |'''k.''' The vendor uses a consistent training methodology for educating new users.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''l.''' Does the vendor supply [[Laboratory information management system|LIMS]]-specific training program curricula?
   | style="padding:5px; width:500px;" |'''l.''' The vendor supplies [[Laboratory information system|LIS]]-specific training program curricula.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''m.''' Does the vendor provide user, administrator, developer, installation, and reference manuals? Give details.
   | style="padding:5px; width:500px;" |'''m.''' The vendor provides user, administrator, developer, installation, and reference manuals.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''n.''' Does the vendor provide design qualification documentation?
   | style="padding:5px; width:500px;" |'''n.''' The vendor provides design qualification documentation.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''o.''' Does the vendor provide installation qualification documentation?
   | style="padding:5px; width:500px;" |'''o.''' The vendor provides installation qualification documentation.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''p.''' Does the vendor provide operation qualification documentation?
   | style="padding:5px; width:500px;" |'''p.''' The vendor provides operation qualification documentation.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''q.''' Does the vendor provide performance qualification documentation during implementation?
   | style="padding:5px; width:500px;" |'''q.''' The vendor provides performance qualification documentation during implementation.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''r.''' Does the vendor provide well-documented system upgrades that authorized users can independently install?
   | style="padding:5px; width:500px;" |'''r.''' The vendor provides well-documented system upgrades that authorized users can independently install.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''s.''' Does the vendor provide source code for the system?
   | style="padding:5px; width:500px;" |'''s.''' The vendor provides source code for the system.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''t.''' Does the vendor provide an optional comprehensive set of test codes suitable for use by the purchasing facility?
   | style="padding:5px; width:500px;" |'''t.''' The vendor provides an optional comprehensive set of test codes suitable for use by the purchaser.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
Line 179: Line 180:
   ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
   ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
  |-  
  |-  
   | style="padding:5px; width:500px;" |'''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?
   | style="padding:5px; width:500px;" |'''a.''' The system operates with a traditional client-server architecture, with software installed on each machine that needs to access the system.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''b.''' Does your system contain a single database that supports multiple laboratory sites and departments?
   | style="padding:5px; width:500px;" |'''b.''' The system operates with a web-based interface, hosted on a server and accessed via a web browser on most any machine.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''c.''' Does your system's database conform to the [[ODBC|Open Database Connectivity Standard]] (ODBC)?
   | style="padding:5px; width:500px;" |'''c.''' The system contains a single, centralized database that supports multiple sites and departments.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''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.
   | style="padding:5px; width:500px;" |'''d.''' The system's database conforms to the [[ODBC|Open Database Connectivity Standard]] (ODBC).
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''e.''' Did you design your system to not be impacted by multiple users or failover processes? Please describe.
   | style="padding:5px; width:500px;" |'''e.''' The system is designed so upgrades to the back-end database do not require extensive reconfiguration or effectively cripple the system.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''f.''' Does your system apply security features to all system files?
   | style="padding:5px; width:500px;" |'''f.''' The system is designed to not be impacted by multiple users or failover processes.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''g.''' Does your system apply login security to all servers and workstations accessing it?
   | style="padding:5px; width:500px;" |'''g.''' The system applies security features to all system files.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''h.''' Does your system provide a workstation and server authentication mechanism?
   | style="padding:5px; width:500px;" |'''h.''' The system applies log-in security to all servers and workstations accessing it.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''i.''' Does your system apply Secured Socket Layer (SSL) encryption on the web client interface?
   | style="padding:5px; width:500px;" |'''i.''' The system provides a workstation and server authentication mechanism.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''j.''' Does your system encrypt client passwords in a database with support for multi-case and special characters?
   | style="padding:5px; width:500px;" |'''j.''' The system applies Secured Socket Layer (SSL) encryption on the web client interface.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''k.''' Does your system provide all secured users access to its data via the Internet, LAN, or direct modem connection?
   | style="padding:5px; width:500px;" |'''k.''' The system encrypts client passwords in a database, with support for multi-case and special characters.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''l.''' Does your system use TCP/IP as its network transport?
   | style="padding:5px; width:500px;" |'''l.''' The system uses TCP/IP as its network transport.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''m.''' Does your system contain an archive utility that doesn't require off-line mode?
   | style="padding:5px; width:500px;" |'''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.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''n.''' Does your system provide local backup and restore capability without support intervention?
   | style="padding:5px; width:500px;" |'''n.''' The system allows automated backup and restore capability without support intervention, as well as manual backups.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''o.''' Does your system maintain the transactional history of system administrators?
   | style="padding:5px; width:500px;" |'''o.''' The system maintains the transactional history of system administrators.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''p.''' Does your system architecture facilitate the incorporation of new technology and interfaces?
   | style="padding:5px; width:500px;" |'''p.''' The system maintains an analyst communication log, accessible by the administrator.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
|}
|}
===1.2.2 Hardware environment===
===1.2.2 Hardware environment===
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
Line 253: Line 255:
   ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
   ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
  |-  
  |-  
   | style="padding:5px; width:500px;" |'''a.''' Does your system prove compatible with a variety of hardware environments? Please describe how.
   | style="padding:5px; width:500px;" |'''a.''' The system proves compatible with a variety of hardware environments.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''b.''' The system can be utilized with a touch-screen.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
|}
|}
===1.2.3 Software environment===
===1.2.3 Software environment===
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
Line 267: Line 274:
   ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
   ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
  |-  
  |-  
   | style="padding:5px; width:500px;" |'''a.''' Does your system utilize a non-proprietary database such as Oracle or Microsoft SQL Server? Please explain.
   | style="padding:5px; width:500px;" |'''a.''' The system proves compatible with a variety of software environments.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''b.''' Does your system prove compatible with a variety of software environments? Please describe how.
   | style="padding:5px; width:500px;" |'''b.''' The system utilizes a non-proprietary database such as Oracle or Microsoft SQL Server.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
|}
|}
|}


Line 290: Line 296:
   ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
   ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
  |-  
  |-  
   | style="padding:5px; width:500px;" |'''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.
   | style="padding:5px; width:500px;" |'''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.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''b.''' The system supports [[ISO/IEC 17025]] requirements.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''b.''' Does your system support [[ISO/IEC 17025]] requirements? Please explain how.
   | style="padding:5px; width:500px;" |'''c.''' The system supports [[HIPAA]] requirements.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''c.''' Does your system support [[HIPAA]] requirements? Please explain how.
   | style="padding:5px; width:500px;" |'''d.''' The system supports [[GALP]] and/or [[GAMP]] standards.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''d.''' Does your system support [[GALP]] and/or [[GAMP]] standards? Please explain how.
   | style="padding:5px; width:500px;" |'''e.''' The system supports the standards of [[The NELAC Institute]].
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''e.''' Does your system support the standards [[The NELAC Institute]]? Please explain how.
   | style="padding:5px; width:500px;" |'''f.''' The system meets government requirements for handling classified information and documents.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''f.''' Does your system meet government requirements for handling classified information and documents?
   | style="padding:5px; width:500px;" |'''g.''' The system maintains [[audit trail|audit]] and specification violation trails of all data manipulation — such as result and header information changes — as consistent with all applicable regulations and standards.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''g.''' Does your system maintain [[audit trail|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.
   | style="padding:5px; width:500px;" |'''h.''' The system maintains audit trails at least as long as the records to which they pertain.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''h.''' Does your system's audit log retain all data, prohibit any deletions, and allows user comments?
   | style="padding:5px; width:500px;" |'''i.''' The system's audit log retains all data, prohibits any deletions, allows user comments, and allows reporting of contained information.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''i.''' Does your system provide additional persistent auditing capabilities? If so, what?
   | style="padding:5px; width:500px;" |'''j.''' The system provides additional persistent auditing capabilities, such as the audit of cancelled tests and scheduled system functions.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''j.''' Does your system provide user-selectable [[The NELAC Institute|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.
   | style="padding:5px; width:500px;" |'''k.''' The system provides user-selectable [[The NELAC Institute|NELAP]]-compliant internal [[chain of custody]] that tracks all specimens and associated containers from the time they are collected until disposed of.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''k.''' Does your system provide the ability to insert/manage secure [[ELN feature#Electronic signatures|electronic]] and/or digital signatures?
   | style="padding:5px; width:500px;" |'''l.''' The system provides the ability to insert/manage secure [[ELN feature#Electronic signatures|electronic]] and/or digital signatures.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''l.''' Does your system incorporate automatic date and time stamping of additions, changes, etc.?
   | style="padding:5px; width:500px;" |'''m.''' The system incorporates automatic date and time stamping of additions, changes, etc.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''n.''' The system can automatically validate and approve data prior to being moved to the main database.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
|}
|}
===1.3.2 Security===
===1.3.2 Security===
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
Line 348: Line 363:
   ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
   ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
  |-  
  |-  
   | style="padding:5px; width:500px;" |'''a.''' Does your system allow system administrators and managers to configure multiple levels of user rights and security by site location, department, [[LIMS feature#Configurable roles and security|role]], and/or specific function? Please explain the depth of this security.
   | style="padding:5px; width:500px;" |'''a.''' The system allows administrators and other authorized users to configure multiple levels of user rights and security by site location, department, group, [[LIMS feature#Configurable roles and security|role]], and/or specific function.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''b.''' The system allows administrators and users to reset user passwords.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''b.''' Does your system allow administrators to reset user passwords?
   | style="padding:5px; width:500px;" |'''c.''' The system features and enforces adjustable rules concerning password complexity, reuse, and expiration.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''c.''' Does your system enforce rules concerning password complexity, reuse, and expiration? If so, how?
   | style="padding:5px; width:500px;" |'''d.''' The system can lock a user out after a specified number of consecutive failed log-in attempts.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
Line 364: Line 383:
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''e.''' Does your system prompt users for a reason for database record changes?
   | style="padding:5px; width:500px;" |'''e.''' The system provides the option for automatic user logout based on keyboard or mouse inactivity.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''f.''' Does your system allow administrators to modify records, while also maintaining an audit trail of such actions?
   | style="padding:5px; width:500px;" |'''f.''' The system makes authority checks to ensure only authorized individuals can use the system to perform an operation.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''g.''' Does your system allow authorized personnel to review audit logs at will?
   | style="padding:5px; width:500px;" |'''g.''' The system allows authorized users to modify records, while also maintaining an audit trail of such actions.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''h.''' Does your system allow authorized users to query and print chain of custody for items, cases, projects, and batches?
   | style="padding:5px; width:500px;" |'''h.''' The system allows authorized users to manually delete records, while also maintaining an audit trail of such actions.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''i.''' Does your system allow supervisors to override chain of custody?
   | style="padding:5px; width:500px;" |'''i.''' The system prompts users to declare a reason for making changes to or deleting data in the system.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''j.''' Does your system provide email notification of lockout, security access, and improper workstation access?
   | style="padding:5px; width:500px;" |'''j.''' The system provides email notification of lockout, security access, and improper workstation access.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''k.''' Does your system allow multiple users to connect simultaneously to a contract lab?
   | style="padding:5px; width:500px;" |'''k.''' The system provides a mechanism to allow a user read-only access to stored data.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''l.''' Does your system provide read-only access to contract laboratory results?
   | style="padding:5px; width:500px;" |'''l.''' The system allows authorized users to generate a detailed user access record.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''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?
   | style="padding:5px; width:500px;" |'''m.''' The system allows authorized users to review audit logs at will.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''n.''' The system allows authorized users to query and print chain of custody for items, cases, projects, and batches.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''o.''' The system allows supervisors to override chain of custody.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''p.''' The system automatically tracks when supervisors review critical result values.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''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.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''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.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''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.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''t.''' The system employs automatic file encryption on stored data.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''u.''' The system employs checks to enforce permitted sequencing of steps and events.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''v.''' The system allows multiple users to connect simultaneously to a contract lab.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''w.''' The system provides read-only access to contract laboratory results.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''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.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
|}
|}
|}


Line 415: Line 477:
   ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
   ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
  |-  
  |-  
   | style="padding:5px; width:500px;" |'''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?
   | style="padding:5px; width:500px;" |'''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.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''b.''' Does your system permit remote access for users, system admins, and support agents?
   | style="padding:5px; width:500px;" |'''b.''' The system allows authorized users to configure their GUI to a specific language, character set, and time zone.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''c.''' Does your system allow for the use of navigation keys to freely move from field to field?
   | style="padding:5px; width:500px;" |'''c.''' The system permits remote access for users, system admins, and support agents.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''d.''' Does your system allow data tables to be sorted?
   | style="padding:5px; width:500px;" |'''d.''' The system allows for the use of navigation keys to freely move from field to field.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''e.''' Can your system send on-screen output to a printer or file? If so, does it contradict view-only statuses?
   | style="padding:5px; width:500px;" |'''e.''' The system allows tabular data to be sorted and filtered.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''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?
   | style="padding:5px; width:500px;" |'''f.''' The system can send on-screen output to a printer or file without contradicting view-only statuses.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''g.''' Does your system support multiple users entering data simultaneously?
   | style="padding:5px; width:500px;" |'''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.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''h.''' Does your system eliminate (or significantly reduce) redundant data entry and paper trails? If so, how?
   | style="padding:5px; width:500px;" |'''h.''' The system eliminates (or significantly reduces) redundant data entry and paper trails.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''i.''' Does your system contain one or more spell-check dictionaries that allow authorized users to add, edit, or remove entries?
   | style="padding:5px; width:500px;" |'''i.''' The system contains one or more spell-check dictionaries that allow authorized users to add, edit, or remove entries.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''j.''' Does your system provide full database keyword and field [[LIMS feature#Query capability|search capability]], including the use of multiple search criteria?
   | style="padding:5px; width:500px;" |'''j.''' The system provides full database keyword and field [[LIS feature#Query capability|search capability]], including the use of multiple search criteria.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''k.''' Does your system include the ability to search multiple databases, including those containing legacy data?
   | style="padding:5px; width:500px;" |'''k.''' The system includes the ability to search multiple databases, including those containing legacy data.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''l.''' Does your system interface with or [[LIMS feature#Import data|import existing data]] from other systems and/or databases?
   | style="padding:5px; width:500px;" |'''l.''' The system allows users to build, save, and edit queries for future use.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''m.''' Does you system cleanly convert migrated data to allow for reporting of historical sample collections? If so, how?
   | style="padding:5px; width:500px;" |'''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.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''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?
   | style="padding:5px; width:500px;" |'''n.''' The system cleanly converts migrated data to allow for reporting of historical specimen collections.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''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?
   | style="padding:5px; width:500px;" |'''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.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''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?
   | style="padding:5px; width:500px;" |'''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.  
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''q.''' Does your system issue sequential numbers for chain of custody?
   | style="padding:5px; width:500px;" |'''q.''' The system can manage and store media objects like digital photos, bitmaps, movies, and audio files.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''r.''' Does your system's numbering scheme allow for sub-numbering while maintaining parent-child relationships?
   | style="padding:5px; width:500px;" |'''r.''' The system issues sequential numbers for chain of custody.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''s.''' Does your system efficiently utilize standardized data input points and enhanced individual workload tracking?
   | style="padding:5px; width:500px;" |'''s.''' The system's numbering scheme allows for sub-numbering while maintaining parent-child relationships.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''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?
   | style="padding:5px; width:500px;" |'''t.''' The system efficiently utilizes standardized data input points and enhanced individual workload tracking.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''u.''' Does your system link or embed standard operation procedures (SOPs) to/in other objects like analysis requests and test results?
   | style="padding:5px; width:500px;" |'''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.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''v.''' Does your system [[LIMS feature#Alarms and/or alerts|notify users]] of events like the scheduling, receipt, and completion of tasks?
   | style="padding:5px; width:500px;" |'''v.''' The system can link objects to other objects, e.g. linking a standard operating procedure (SOP) to a test result.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''w.''' Does your system include the ability to set up alerts via email?
   | style="padding:5px; width:500px;" |'''w.''' The system [[LIMS feature#Alarms and/or alerts|notifies users]] of events like the scheduling, receipt, and completion of tasks.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''x.''' Does your system maintain an analyst communication log?
   | style="padding:5px; width:500px;" |'''x.''' The system includes the ability to set up alerts via email.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''y.''' The system has real-time messaging capabilities, including instant messaging to one or more users.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''z.''' The system supports the use of a voice recognition system (for navigation or transcription) or has that functionality.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''aa.''' The system offers integrated or online user help screens.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
|}
|}
===1.4.2 Configuration and customization===
===1.4.2 Configuration and customization===
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
Line 521: Line 596:
   ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
   ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
  |-  
  |-  
   | style="padding:5px; width:500px;" |'''a.''' Can your system can be configured to meet the workflow of a laboratory without additional programming? Please explain how.
   | style="padding:5px; width:500px;" |'''a.''' The system can be configured to meet the workflow of a laboratory without additional programming.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''b.''' Can your system easily and efficiently be modified to meet lab growth and changing business needs? Please explain how.
   | style="padding:5px; width:500px;" |'''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.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''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)?
   | style="padding:5px; width:500px;" |'''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.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''d.''' Can your system expand to accommodate a new discipline? If so, how?
   | style="padding:5px; width:500px;" |'''d.''' The system can expand to accommodate a new discipline.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''e.''' Can your system support [[LIMS feature#Customizable fields and/or interface|customized screens]] with user-definable information specific to a customer, department, analysis, etc.?
   | style="padding:5px; width:500px;" |'''e.''' The system supports [[LIMS feature#Customizable fields and/or interface|customized screens]] with user-definable information specific to a customer, department, analysis, etc.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''f.''' Does your system allow the administrator to create custom screens, applications, and reports? Please give details.
   | style="padding:5px; width:500px;" |'''f.''' The system allows the administrator to create custom screens, applications, and reports.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''g.''' Does the system allow a user to [[LIMS feature#Customizable fields and/or interface|independently add fields]] without requiring reconfiguration of the system, even after routine upgrades and maintenance?
   | style="padding:5px; width:500px;" |'''g.''' The system allows a user to [[LIMS feature#Customizable fields and/or interface|independently add fields]] without requiring reconfiguration of the system, even after routine upgrades and maintenance.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''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?
   | style="padding:5px; width:500px;" |'''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.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''i.''' Does your system support the definition and maintenance of edit tables and lists?
   | style="padding:5px; width:500px;" |'''i.''' The system supports the definition and maintenance of edit tables and lists.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''j.''' Does your system dynamically change captions (labels) on system fields?
   | style="padding:5px; width:500px;" |'''j.''' The system dynamically changes captions (labels) on system fields.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''k.''' Does your system have dynamically configurable limit periods and notification hierarchy?
   | style="padding:5px; width:500px;" |'''k.''' The system has dynamically configurable limit periods and notification hierarchy.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''l.''' Does your system allow for the integration of additional printers and scanners both locally and externally?
   | style="padding:5px; width:500px;" |'''l.''' The system allows for the integration of additional printers and scanners both locally and externally.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
|}
|}
===1.4.3 Receiving and scheduling===
===1.4.3 Receiving and scheduling===
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
Line 579: Line 655:
   ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
   ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
  |-  
  |-  
   | style="padding:5px; width:500px;" |'''a.''' Does your system track status and [[workflow]] of the [[Accessioning (medical)|accession]] throughout the laboratory lifecycle, from submission to final analysis, including receiving, diagnostic testing, diagnostic test result reporting, and billing?
   | style="padding:5px; width:500px;" |'''a.''' The system tracks status and [[workflow]] of the [[Accessioning (medical)|accession]] throughout the laboratory lifecycle, from submission to final analysis, including receiving, diagnostic testing, diagnostic test result reporting, and billing.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''b.''' The system supports [[LIMS feature#Barcode support|barcoded specimen]] labeling and tracking.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''c.''' The system allows users to create, manage, and track viewable sample container schemata.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''d.''' The system creates and maintains a unique electronic accession record for each accession received.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''e.''' The system supports standard-format digital picture and document upload and attachment to electronic accession records.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''f.''' The system supports a user-configurable, spreadsheet-style, templated ''multi-specimen'' ([[LIMS feature#Sample and result batching|batch]]) login without requiring additional programming.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''b.''' Does your system support [[LIMS feature#Barcode support|barcoded specimen]] labeling and tracking?
   | style="padding:5px; width:500px;" |'''g.''' The system supports the modification of specimen or specimen batch information prior to actual ''multi-sample'' (batch) login.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''c.''' Does your system create and maintain a unique electronic accession record for each accession received?
   | style="padding:5px; width:500px;" |'''h.''' The system supports ad-hoc specimens not predefined in the specimen point list during ''multi-sample'' (batch) login.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''d.''' Does your system support standard-format digital picture and document upload and attachment to electronic accession records?
   | style="padding:5px; width:500px;" |'''i.''' The system creates, saves, and recalls pre-login groups for routine samples to simplify recurring logins.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''e.''' Does your system support a user-configurable, spreadsheet-style, templated ''multi-sample'' ([[LIMS feature#Sample and result batching|batch]]) login without requiring additional programming?
   | style="padding:5px; width:500px;" |'''j.''' The system streamlines the [[LIMS feature#Sample login and management|login]] of recurring sample projects.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''f.''' Does your system support the modification of sample or sample batch information prior to actual ''multi-sample'' (batch) login?
   | style="padding:5px; width:500px;" |'''k.''' The system automatically [[LIMS feature#Label support|generates labels]] for recurring samples and sample groups.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''g.''' Does your system support ad-hoc samples not predefined in the sample point list during ''multi-sample'' (batch) login?
   | style="padding:5px; width:500px;" |'''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.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''h.''' Does your system create, save, and recall pre-login groups for routine samples to simplify recurring logins?
   | style="padding:5px; width:500px;" |'''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.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''i.''' Does your system streamline the [[LIMS feature#Sample login and management|login]] of recurring sampling projects?
   | style="padding:5px; width:500px;" |'''n.''' The system includes [[LIMS feature#Environmental monitoring|environmental monitoring]] (EM) functionality or integrates with an external EM product.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''j.''' Does your system automatically [[LIMS feature#Label support|generate labels]] for recurring samples and sample groups?
   | style="padding:5px; width:500px;" |'''o.''' The system prevents a sample from being placed in a report queue until approved.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''k.''' Does your system allow authorized users to generate user-definable chain of custodies, worksheets, routing sheets, and custom labels upon sample login?
   | style="padding:5px; width:500px;" |'''p.''' The system includes comprehensive [[LIMS feature#Task and event scheduling|scheduling]], [[LIMS feature#Sample tracking|tracking]], and [[LIMS feature#Workflow management|flow management]] of samples, including across multiple sites.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''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?
   | style="padding:5px; width:500px;" |'''q.''' The system is capable of geographically organizing sample records and their associated tests for special analysis and reporting.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''m.''' Does your system include [[LIMS feature#Environmental monitoring|environmental monitoring]] (EM) functionality or integrate with an external EM product?
   | style="padding:5px; width:500px;" |'''r.''' The system allows authorized users to accept, cancel, re-run, and override attributes of one or multiple tests for a given sample.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''n.''' Does your system prevent a sample from being placed in a report queue until approved?
   | style="padding:5px; width:500px;" |'''s.''' The system allows authorized users to review the available test types in the system, including their reference range and units of measure.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''o.''' Does your system include comprehensive [[LIMS feature#Task and event scheduling|sample scheduling]], [[LIMS feature#Sample tracking|tracking]], and sample [[LIMS feature#Workflow management|flow management]]?
   | style="padding:5px; width:500px;" |'''t.''' The system has a "miscellaneous" test code to allow a test undefined in the system to be ordered and billed.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''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?
   | style="padding:5px; width:500px;" |'''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.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''q.''' Does your system generate an hourly, daily, weekly, or monthly sampling schedule from a schedule database?
   | style="padding:5px; width:500px;" |'''v.''' The system generates an hourly, daily, weekly, or monthly sample collection schedule from a scheduling database.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''r.''' Does your system schedule and [[LIMS feature#Project and/or task management|assign tasks]] based on available inventory and personnel?
   | style="padding:5px; width:500px;" |'''w.''' The system schedules and [[LIMS feature#Project and/or task management|assign tasks]] based on available inventory and personnel.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''s.''' Does your system support automatic assignment and scheduling of [[LIMS feature#Data and trend analysis|analysis requests]]?
   | style="padding:5px; width:500px;" |'''x.''' The system supports automatic assignment and scheduling of [[LIMS feature#Data and trend analysis|analysis requests]].
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''t.''' Can your system receive accession/analysis request information from web-enabled forms?
   | style="padding:5px; width:500px;" |'''y.''' The system receives accession/analysis request information from web-enabled forms.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''u.''' Can your system electronically receive and process collection and analysis request information and schedules from third parties?
   | style="padding:5px; width:500px;" |'''z.''' The system electronically receives and processes collection and analysis request information and schedules from third parties.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''v.''' Does your system have an inter-lab transfer function?
   | style="padding:5px; width:500px;" |'''aa.''' The system has an inter-lab transfer function.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''w.''' Can your system process automated uploading of field-derived sample collection data?
   | style="padding:5px; width:500px;" |'''ab.''' The system processes automated uploading of field-derived sample collection data.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''x.''' Does your system allows users to handle billable and non-billable tests on the same accession?
   | style="padding:5px; width:500px;" |'''ac.''' The system allows users to handle billable and non-billable tests on the same accession.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''y.''' Does your system support tracking of shipping and receiving?
   | style="padding:5px; width:500px;" |'''ad.''' The system supports tracking of shipping and receiving.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
|}
|}
===1.4.4 Analysis and data entry===
===1.4.4 Analysis and data entry===
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
Line 689: Line 786:
   ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
   ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
  |-  
  |-  
   | style="padding:5px; width:500px;" |'''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.
   | style="padding:5px; width:500px;" |'''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.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''b.''' Does your system provide normal data range values for diagnostic tests?
   | style="padding:5px; width:500px;" |'''b.''' The system provides and enforces normal data range values for diagnostic tests.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''c.''' Does your system includes default input values for diagnostic tests?
   | style="padding:5px; width:500px;" |'''c.''' The system includes default input values for diagnostic tests.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''d.''' Does your system provide for a single test code requiring multiple analytes as targets?
   | style="padding:5px; width:500px;" |'''d.''' The system provides for a single test code requiring multiple analytes as targets.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''e.''' Does your system limit test code authorization to only qualified personnel and maintain their certification(s) to run assigned tests?
   | style="padding:5px; width:500px;" |'''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.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''f.''' Does your system support and qualify text-based tests?
   | style="padding:5px; width:500px;" |'''f.''' The system limits test code authorization to only qualified personnel and maintains their certification(s) to run assigned tests.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''g.''' Does your system support single-component tests such as pH, BOD, CD, etc.?
   | style="padding:5px; width:500px;" |'''g.''' The system supports and qualifies text-based tests.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''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?
   | style="padding:5px; width:500px;" |'''h.''' The system supports single-component tests such as pH, BOD, CD, etc.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''i.''' Does your system permit user-generated and modifiable calculations (based on a formulaic language) to be applied to all tests?
   | style="padding:5px; width:500px;" |'''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.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''j.''' Does your system distinguish between routine and duplicate analysis?
   | style="padding:5px; width:500px;" |'''j.''' The system can effectively manage complex molecular testing protocols.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''k.''' Does your system provide an overview of all outstanding tests/analyses for better coordination of work schedules?
   | style="padding:5px; width:500px;" |'''k.''' The system can effectively manage genetic testing protocols.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''l.''' Does your system notify analysts of applicable safety hazards associated with a sample, reagent, or test before testing begins?
   | style="padding:5px; width:500px;" |'''l.''' The system permits user-generated and modifiable calculations (based on a formulaic language) to be applied to all tests.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''m.''' Does your system electronically transfer an item during testing from one functional area to another?
   | style="padding:5px; width:500px;" |'''m.''' The system distinguishes between routine and duplicate analysis.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''n.''' Does your system's user interface display visual indicators such as status icons to indicate a sample's status in the workflow?
   | style="padding:5px; width:500px;" |'''n.''' The system provides an overview of all outstanding tests/analyses for better coordination of work schedules.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''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?
   | style="padding:5px; width:500px;" |'''o.''' The system notifies analysts of applicable safety hazards associated with a sample, reagent, or test before testing begins.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''p.''' Does your system permit [[LIMS feature#Option for manual result entry|manual data entry]] into an electronic worksheet of test measurements and results?
   | style="padding:5px; width:500px;" |'''p.''' The system electronically transfers an item during testing from one functional area to another.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''q.''' Does your system allow incorrectly inputted data to be manually corrected?
   | style="padding:5px; width:500px;" |'''q.''' The system's user interface displays visual indicators such as status icons to indicate a sample's status in the workflow.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''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?
   | style="padding:5px; width:500px;" |'''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.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''s.''' Does your system allow automated or semi-automated data insertion?
   | style="padding:5px; width:500px;" |'''s.''' The system permits [[LIMS feature#Option for manual result entry|manual data entry]] into an electronic worksheet of test measurements and results.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''t.''' Does your system store non-narrative textual results in searchable fields?
   | style="padding:5px; width:500px;" |'''t.''' The system allows incorrectly inputted data to be manually corrected.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''u.''' The system prevents out-of-range and other critical results from being posted as final.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''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.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''w.''' The system allows automated or semi-automated data insertion.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''x.''' The system stores non-narrative textual results in searchable fields.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
|}
|}
===1.4.5 Post-analysis and validation===
===1.4.5 Post-analysis and validation===
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
Line 779: Line 893:
   ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
   ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
  |-  
  |-  
   | style="padding:5px; width:500px;" |'''a.''' Does your system update sample/item status when tests are completed?
   | style="padding:5px; width:500px;" |'''a.''' The system updates sample/item status when tests are completed.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''b.''' Does your system read results from previously entered tests to calculate a final result and immediately display the calculated result?
   | style="padding:5px; width:500px;" |'''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.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''c.''' Does your system allow authorized users to review all analytical results, including pricing, spec violations, history or trend analysis by analyte, and comments?
   | style="padding:5px; width:500px;" |'''c.''' The system reads results from previously entered tests to calculate a final result and immediately displays the calculated result.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''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)?
   | style="padding:5px; width:500px;" |'''d.''' The system allows authorized users to review all analytical results, including pricing, spec violations, history or trend analysis by analyte, and comments.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''e.''' Does your system display the standard operating procedure (SOP) associated with each test result to ensure proper techniques were used?
   | style="padding:5px; width:500px;" |'''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.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''f.''' Does your system store test-related analysis comments with the test?
   | style="padding:5px; width:500px;" |'''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).
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''g.''' Does your system provide auto-commenting for common laboratory result comments?
   | style="padding:5px; width:500px;" |'''g.''' The system includes data mining tools for model learning, evaluation, and usage.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''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?
   | style="padding:5px; width:500px;" |'''h.''' The system displays the standard operating procedure (SOP) associated with each test result to ensure proper techniques were used.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''i.''' Does your system's results [[LIMS feature#Data validation|validation process]] access all information about a sample or group of samples, including comments or special information about the sample?
   | style="padding:5px; width:500px;" |'''i.''' The system stores test-related analysis comments with the test.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''j.''' Does your system's results validation process check each result against its individual sample location specifications (both warning and specification limits)?
   | style="padding:5px; width:500px;" |'''j.''' The system provides auto-commenting for common laboratory result comments.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''k.''' Does your system support validation at the analysis and sample level, while also prohibiting sample validation when analysis validation is incomplete?
   | style="padding:5px; width:500px;" |'''k.''' The system is capable of displaying entered order and test comments as an onscreen alert for testing and other personnel.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''l.''' Does your system use a menu-driven process for results validation?
   | style="padding:5px; width:500px;" |'''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.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''m.''' Does your system provide secure electronic peer review of results?
   | style="padding:5px; width:500px;" |'''m.''' The system's results [[LIMS feature#Data validation|validation process]] accesses all information about a sample or group of samples, including comments or special information about the sample.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''n.''' Can your system clearly differentiate released preliminary data from fully validated results?
   | style="padding:5px; width:500px;" |'''n.''' The system's results validation process checks each result against its individual sample location specifications (both warning and specification limits).
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''o.''' Does your system validate/approve data prior to being moved to the main database?
   | style="padding:5px; width:500px;" |'''o.''' The system supports validation at the analysis and sample level, while also prohibiting sample validation when analysis validation is incomplete.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''p.''' Does your system fully manage all aspects of laboratory [[LIMS feature#QA/QC functions|quality control]], including the reporting and charting of all quality control data captured in the lab? Please explain how.
   | style="padding:5px; width:500px;" |'''p.''' The system uses a menu-driven process for results validation.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''q.''' Does your system provide a base for a quality assurance program, including proficiency testing, scheduled maintenance of equipment, etc.? Please explain how.
   | style="padding:5px; width:500px;" |'''q.''' The system provides secure electronic peer review of results.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''r.''' Does your system distinguish QA/QC duplicates from normal samples?
   | style="padding:5px; width:500px;" |'''r.''' The system clearly differentiates released preliminary data from fully validated results.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''s.''' Does your system allow QA/QC tests to be easily created and associated with the primary analytical test?
   | style="padding:5px; width:500px;" |'''s.''' The system validates/approves data prior to being moved to the main database.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''t.''' Does your system allow manual entry of QA and QC data not captured as part of the system's regular processes?
   | style="padding:5px; width:500px;" |'''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.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''u.''' Does your system calculate monthly QA/QC percentages for testing?
   | style="padding:5px; width:500px;" |'''u.''' The system fully manages all aspects of laboratory [[LIMS feature#QA/QC functions|quality control]], including the reporting and charting of all quality control data captured in the lab.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''v.''' Does your system automatically flag out-of-range quality control limits?
   | style="padding:5px; width:500px;" |'''v.''' The system provides a base for a quality assurance program, including proficiency testing, scheduled maintenance of equipment, etc.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''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?
   | style="padding:5px; width:500px;" |'''w.''' The system distinguishes QA/QC duplicates from normal samples.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''x.''' The system allows QA/QC tests to be easily created and associated with the primary analytical test.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''y.''' The system allows manual entry of QA and QC data not captured as part of the system's regular processes.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''z.''' The system calculates monthly QA/QC percentages for testing.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''aa.''' The system automatically flags out-of-range quality control limits.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''ab.''' The system is able to flag results for aspects other than being out-of-range, including testing location, test subject age, etc.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''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.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
|}
|}
===1.4.6 Instruments===
===1.4.6 Instruments===
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
Line 881: Line 1,020:
   ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
   ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
  |-  
  |-  
   | style="padding:5px; width:500px;" |'''a.''' Does your system bilaterally [[LIMS feature#Instrument interfacing and management|interface with instruments]] and related software? If so, please provide details.
   | style="padding:5px; width:500px;" |'''a.''' The system bilaterally [[LIMS feature#Instrument interfacing and management|interfaces with instruments]] and related software.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''b.''' Can your system download data directly from laboratory instruments?
   | style="padding:5px; width:500px;" |'''b.''' The system downloads data directly from laboratory instruments.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''c.''' Does your system permit the defining and exporting of sequences to instruments?
   | style="padding:5px; width:500px;" |'''c.''' The system permits the defining and exporting of sequences to instruments.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''d.''' Does your system track and report on laboratory equipment usage?
   | style="padding:5px; width:500px;" |'''d.''' The system tracks and reports on the usage of attached laboratory instruments.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''e.''' Does your system allow automatic or manual reservation/scheduling of laboratory instruments?
   | style="padding:5px; width:500px;" |'''e.''' The system allows automatic or manual reservation/scheduling of laboratory instruments.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''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?
   | style="padding:5px; width:500px;" |'''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.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''g.''' Does your system provide a database of preventative maintenance, calibration, and repair records for laboratory equipment, preferably supported by standardized reporting?
   | style="padding:5px; width:500px;" |'''g.''' The system provides a database of preventative maintenance, calibration, and repair records for laboratory equipment, preferably supported by standardized reporting.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''h.''' Can your system schedule calibration/verification tasks in the worksheets or work flow process?
   | style="padding:5px; width:500px;" |'''h.''' The system schedules calibration, verification, and maintenance tasks in the worksheets or work flow process and make that schedule available for viewing.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''i.''' The system allows users to create and edit instrument maintenance profiles.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
|}
|}
===1.4.7 External system interfaces===
===1.4.7 External system interfaces===
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
Line 923: Line 1,067:
   ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
   ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
  |-  
  |-  
   | style="padding:5px; width:500px;" |'''a.''' Does your system support a library of common and/or basic electronic data deliverable (EDD) formats? If so, which?
   | style="padding:5px; width:500px;" |'''a.''' The system supports a library of common electronic data deliverable (EDD) formats.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''b.''' The system transfers data to and from another record management system.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''c.''' The system [[LIS feature#Third-party software integration|integrates]] with Microsoft Exchange services.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''b.''' Can your system transfer data to and from another record management system? If so, how?
   | style="padding:5px; width:500px;" |'''d.''' The system [[LIMS feature#Import data|imports data]] from and exports data to Microsoft Word, Excel, and/or Access.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''c.''' Does your system [[LIS feature#Third-party software integration|integrate]] with Microsoft Exchange services?
   | style="padding:5px; width:500px;" |'''e.''' The system can interface with non-Microsoft programs.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''d.''' Can your system [[LIMS feature#Import data|import data]] from and export data to Microsoft Word, Excel, and/or Access?
   | style="padding:5px; width:500px;" |'''f.''' The system interfaces with external billing systems.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''e.''' Can your system interface with non-Microsoft programs? If so, which?
   | style="padding:5px; width:500px;" |'''g.''' The system interfaces with enterprise resource planning (ERP) systems.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''f.''' Can your system interface with external billing systems? If so, how?
   | style="padding:5px; width:500px;" |'''h.''' The system interfaces with external contract or reference laboratories to electronically send or retrieve datasheets, analysis reports, and other related information.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''g.''' Can your system interface with enterprise resource planning (ERP) systems? If so, how?
   | style="padding:5px; width:500px;" |'''i.''' The system exchanges data with National Identification System (NAIS) tracking systems.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''h.''' Can your system interface with contract laboratories to electronically retrieve datasheets, sample analysis, and other related information?
   | style="padding:5px; width:500px;" |'''j.''' The system generates and exchanges data with other systems using [[Health Level 7]] (HL7) standards.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''i.''' Can your system exchange data with National Identification System (NAIS) tracking systems?
   | style="padding:5px; width:500px;" |'''k.''' The system leverages the application programming interface (API) of other systems to establish integration between systems.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''j.''' Can your system generate and exchange data with other systems using [[Health Level 7]] (HL7) standards?
   | style="padding:5px; width:500px;" |'''l.''' The system provides a real-time interface for viewing live and stored data transactions and errors generated by interfaced instruments and systems.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''k.''' Can your system leverage the application programming interface (API) of other systems to establish integration between systems?
   | style="padding:5px; width:500px;" |'''m.''' The system transmits status changes of specimens, inventory, equipment, etc. to an external system.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''l.''' Can your system transmit status changes of samples, inventory, equipment, etc. to an external system?
   | style="padding:5px; width:500px;" |'''n.''' The system directs output from ad-hoc queries to a computer file for subsequent analysis by other software.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''m.''' Can your system direct output from ad-hoc queries to a computer file for subsequent analysis by other software?
   | style="padding:5px; width:500px;" |'''o.''' The system supports the manual retransmission of data to interfaced systems.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''n.''' Does your system support [[LIMS feature#Mobile device integration|dockable mobile devices]] and handle information exchange between them and the system?
   | style="padding:5px; width:500px;" |'''p.''' The system supports [[LIMS feature#Mobile device integration|dockable mobile devices]] and handle information exchange between them and the system.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''q.''' The system supports the use of optical character recognition (OCR) software.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
|}
|}
===1.4.8 Reporting===
===1.4.8 Reporting===
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
Line 989: Line 1,146:
   ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
   ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
  |-  
  |-  
   | style="padding:5px; width:500px;" |'''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.
   | style="padding:5px; width:500px;" |'''a.''' The system includes a versatile report writer and forms generator that can generate reports from any data in tables.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''b.''' Does your system include a custom graphic generator for forms?
   | style="padding:5px; width:500px;" |'''b.''' The system includes a custom graphic generator for forms.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''c.''' Does your system interface with a third-party reporting application?
   | style="padding:5px; width:500px;" |'''c.''' The system interfaces with a third-party reporting application.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''d.''' Does your system allow the development of [[LIMS feature#Custom reporting|custom templates]] for different types of reports?
   | style="padding:5px; width:500px;" |'''d.''' The system allows the development of [[LIMS feature#Custom reporting|custom templates]] for different types of reports.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''e.''' Does your system maintain template versions and renditions, allowing management and tracking of the template over time?
   | style="padding:5px; width:500px;" |'''e.''' The system maintains template versions and renditions, allowing management and tracking of the template over time.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''f.''' Can your system generate template letters for semi-annual reports?
   | style="padding:5px; width:500px;" |'''f.''' The system generates template letters for semi-annual reports.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''g.''' Does your system support report queries by fields/keys, status, completion, or other variables?
   | style="padding:5px; width:500px;" |'''g.''' The system supports report queries by fields/keys, status, completion, or other variables.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''h.''' Does your system use Microsoft Office tools for formatting reports?
   | style="padding:5px; width:500px;" |'''h.''' The system use Microsoft Office tools for formatting reports.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''i.''' Does your system support multiple web browsers for viewing online reports? If so, list which ones.
   | style="padding:5px; width:500px;" |'''i.''' The system supports multiple web browsers for viewing online reports.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''j.''' Can your system generate, store, reproduce, and display laboratory, statistical, and inventory reports on demand, including narrative?
   | style="padding:5px; width:500px;" |'''j.''' The system generates, stores, reproduces, and displays laboratory, statistical, and inventory reports on demand, including narrative.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''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?
   | style="padding:5px; width:500px;" |'''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.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''l.''' Can your system indicate whether a report is preliminary, amended, corrected, or final while retaining revision history?
   | style="padding:5px; width:500px;" |'''l.''' The system indicates whether a report is preliminary, amended, corrected, or final while retaining revision history.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''m.''' Does your system support both structured and synoptic reporting?
   | style="padding:5px; width:500px;" |'''m.''' The system supports both structured and [[LIS feature#Synoptic reporting|synoptic reporting]].
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''n.''' Can your system generate management and turn-around time reports and graphs?
   | style="padding:5px; width:500px;" |'''n.''' The system generates management and turn-around time reports and graphs.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''o.''' Can your system generate customized final reports?
   | style="padding:5px; width:500px;" |'''o.''' The system generates customized final reports.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''p.''' Can your system automatically generate laboratory reports of findings and other written documents?
   | style="padding:5px; width:500px;" |'''p.''' The system automatically generates laboratory reports of findings and other written documents.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''q.''' Can your system automatically generate individual and aggregate workload and productivity reports on all operational and administrative activities?
   | style="padding:5px; width:500px;" |'''q.''' The system automatically generates individual and aggregate workload and productivity reports on all operational and administrative activities.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''r.''' Can your system automatically generate and transmit exception trails and exception reports for all entered and/or stored out-of-specification data?
   | style="padding:5px; width:500px;" |'''r.''' The system automatically generates and transmits exception trails and exception reports for all entered and/or stored out-of-specification data.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''s.''' Can your system generate a read-only progress report that allows for printed reports of sample status and data collected to date?
   | style="padding:5px; width:500px;" |'''s.''' The system generates a read-only progress report that allows for printed reports of specimen status and data collected to date.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''t.''' Does your system provide an ad-hoc web reporting interface to report on user-selected criteria?
   | style="padding:5px; width:500px;" |'''t.''' The system provides an ad-hoc web reporting interface to report on user-selected criteria.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''u.''' Can your system automatically generate and update control charts?
   | style="padding:5px; width:500px;" |'''u.''' The system automatically generates and updates control charts.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''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?
   | style="padding:5px; width:500px;" |'''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.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''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?
   | style="padding:5px; width:500px;" |'''w.''' The system displays history of previous results for an analyte's specimen point in a tabular report, graphic trend chart, and statistical summary.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''x.''' Can your system automatically generate and post periodic static summary reports on an internal web server?
   | style="padding:5px; width:500px;" |'''x.''' The system automatically generates and posts periodic static summary reports on an internal web server.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''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.
   | style="padding:5px; width:500px;" |'''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.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''z.''' Does your system electronically transmit results via final report only when all case reviews have been completed by the case coordinator?
   | style="padding:5px; width:500px;" |'''z.''' The system electronically transmits results via final report only when all case reviews have been completed by the case coordinator.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''aa.''' Does your system include a rules engine to determine the recipients of reports and other documents based on definable parameters?
   | style="padding:5px; width:500px;" |'''aa.''' The system includes a rules engine to determine the recipients of reports and other documents based on definable parameters.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''ab.''' Does your system allow database access using user-friendly report writing and inquiry tools?
   | style="padding:5px; width:500px;" |'''ab.''' The system allows database access using user-friendly report writing and inquiry tools.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
Line 1,112: Line 1,269:
   ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
   ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
  |-  
  |-  
   | style="padding:5px; width:500px;" |'''a.''' Does your system allow the creation, modification, and duplication of user profiles?
   | style="padding:5px; width:500px;" |'''a.''' The system allows the creation, modification, and duplication of user profiles.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''b.''' Does your system allow entry, maintenance, and administration of [[LIMS feature#Customer and supplier management|customers]], suppliers, and other outside entities?
   | style="padding:5px; width:500px;" |'''b.''' The system allows entry, maintenance, and administration of [[LIMS feature#Customer, supplier, and physician management|customers]], suppliers, and other outside entities.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''c.''' Does your system allow the creation, modification, and maintenance of user [[LIMS feature#Performance evaluation|training records]] and associated training materials?
   | style="padding:5px; width:500px;" |'''c.''' The system allows customers, suppliers, and other such entities to be flagged as either active or inactive.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''d.''' Does your system allow the management of information workflow, including notifications for requests and exigencies?
   | style="padding:5px; width:500px;" |'''d.''' The system allows the creation, modification, and maintenance of user [[LIMS feature#Performance evaluation|training records]] and associated training materials.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''e.''' Does your system allow the [[LIMS feature#Document creation and management|management of documents]] like SOPs, MSDS, etc. to better ensure they are current and traceable?
   | style="padding:5px; width:500px;" |'''e.''' The system supports the ability to set up separate security, inventory, reporting, etc. profiles across multiple facilities.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''f.''' Does your system allow the management and monitoring of resources by analyst, priority, analysis, and instrument?
   | style="padding:5px; width:500px;" |'''f.''' The system allows the management of information workflow, including notifications for requests and exigencies.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''g.''' Does your system allow authorized persons to select and assign tasks by analysts, work group, instrument, test, sample, and priority?
   | style="padding:5px; width:500px;" |'''g.''' The system allows the [[LIMS feature#Document creation and management|management of documents]] like SOPs, MSDS, etc. to better ensure they are current and traceable.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''h.''' Does your system allow authorized persons to review unassigned work by discipline and by lab?
   | style="padding:5px; width:500px;" |'''h.''' The system allows the management and monitoring of resources by analyst, priority, analysis, and instrument.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''i.''' Does your system allow authorized persons to review pending work by analyst prior to assigning additional work?
   | style="padding:5px; width:500px;" |'''i.''' The system allows authorized persons to select and assign tasks by analysts, work group, instrument, test, sample, and priority.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''j.''' Does your system manage and report on reference samples, reagents, and other inventory? If so, to what extent?
   | style="padding:5px; width:500px;" |'''j.''' The system allows authorized persons to review unassigned work by discipline and by lab.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''k.''' Does your system automatically warn specified users when [[LIMS feature#Inventory management|inventory counts]] reach a definable threshold and either prompt for or process a reorder?
   | style="padding:5px; width:500px;" |'''k.''' The system allows authorized persons to review pending work by analyst prior to assigning additional work.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''l.''' Does your system allow authorized users to monitor and report on reference and reagent creation, use, and expiration?
   | style="padding:5px; width:500px;" |'''l.''' The system manages and reports on reference samples, reagents, and other inventory, including by department.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''m.''' Does your system allow authorized users to search [[LIMS feature#Billing management|invoice information]] by invoice number, account number, accession, payment types, client, or requested diagnostic test(s)?
   | style="padding:5px; width:500px;" |'''m.''' The system automatically warns specified users when [[LIMS feature#Inventory management|inventory counts]] reach a definable threshold and either prompt for or process a reorder.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''n.''' Does your system include [[LIMS feature#Performance evaluation|performance assessment]] tracking?
   | style="padding:5px; width:500px;" |'''n.''' The system allows authorized users to monitor and report on reference and reagent creation, use, and expiration.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''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?
   | style="padding:5px; width:500px;" |'''o.''' The system allows authorized users to search [[LIMS feature#Billing and revenue management|invoice information]] by invoice number, account number, accession, payment types, client, or requested diagnostic test(s).
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''p.''' Does your system monitor proficiency test assignment, completion, and casework qualification for analytical staff?
   | style="padding:5px; width:500px;" |'''p.''' The system includes [[LIMS feature#Performance evaluation|performance assessment]] tracking.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''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.
   | style="padding:5px; width:500px;" |'''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.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''r.''' Does your system calculate administrative and lab costs?
   | style="padding:5px; width:500px;" |'''r.''' The system includes an incident tracking system for recording, investigating, and managing safety and accident violations in the laboratory.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''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?
   | style="padding:5px; width:500px;" |'''s.''' The system monitors proficiency test assignment, completion, and casework qualification for analytical staff.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''t.''' Does your system support multiple customer [[LIMS feature#Billing management|payment sources]] (e.g. grants}? Please explain the extent.
   | style="padding:5px; width:500px;" |'''t.''' The system includes revenue management functionality, including profitability analysis.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
  |-
  |-
   | style="padding:5px; width:500px;" |'''u.''' Does your system track number of visits per specific industry?
   | style="padding:5px; width:500px;" |'''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.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''v.''' The system calculates administrative and lab costs.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''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.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''x.''' The system supports multiple customer [[LIS feature#Billing and revenue management|payment sources]] (e.g. grants).
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''y.''' The system tracks number of visits per specific industry.
   | style="background-color:white; padding:5px;" |
   | style="background-color:white; padding:5px;" |
   | style="background-color:white;" |
   | style="background-color:white;" |
Line 1,210: Line 1,383:
{|  
{|  
  | STYLE="vertical-align:top;"|
  | STYLE="vertical-align:top;"|
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0" width="1300px"
  |-  
  |-  
   ! colspan="3" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px; width:1300px;"| 1.7 '''Custom requirements'''
   ! colspan="3" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px; width:1300px;"| 1.7 '''Custom requirements'''

Revision as of 15:43, 8 January 2016

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."

More about this questionnaire

As noted above, this questionnaire was originally designed to cover aspects of a laboratory information management system (LIMS). However, a significant portion of this page if not most of it could easily apply to other laboratory informatics systems like ELNs. As such, we took the approach of adding addenda (as seen in section 1.5 and 1.6) that provide additional requirements unique to other systems and industries. If you're evaluating several industry-neutral LIMS, you likely don't need 1.5 and 1.6.

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.

Printing or saving

The print/export options in the navigation on the far left give you a few options for saving this and other pages, printing them for later.

Notice you'll have to open 1.5 and 1.6 in separate pages to view, print, and save them.

Note: Tables are currently not being rendered in PDFs as we like through the MediaWiki Collection extension. While we sure would love for you to make a PDF of this document, be warned: the tables don't format as intended, using either the "Create a book" or "Download as PDF" processes. For now you're best off selecting "Printable version" and printing that instead.

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. The system supports a variety of test protocols, each capable of storing test comments, test required, and special information like GCMS conditions or special objects associated with the test.
b. The system provides and enforces normal data range values for diagnostic tests.
c. The system includes default input values for diagnostic tests.
d. The system provides for a single test code requiring multiple analytes as targets.
e. The system allows authorized users to make a test code inactive across one or more sites while retaining it for audit and reporting purposes.
f. The system limits test code authorization to only qualified personnel and maintains their certification(s) to run assigned tests.
g. The system supports and qualifies text-based tests.
h. The system supports single-component tests such as pH, BOD, CD, etc.
i. The system allows users to specify a single-component, multi-component, or narrative text test or group of tests, which represent all tests required.
j. The system can effectively manage complex molecular testing protocols.
k. The system can effectively manage genetic testing protocols.
l. The system permits user-generated and modifiable calculations (based on a formulaic language) to be applied to all tests.
m. The system distinguishes between routine and duplicate analysis.
n. The system provides an overview of all outstanding tests/analyses for better coordination of work schedules.
o. The system notifies analysts of applicable safety hazards associated with a sample, reagent, or test before testing begins.
p. The system electronically transfers an item during testing from one functional area to another.
q. The system's user interface displays visual indicators such as status icons to indicate a sample's status in the workflow.
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.
s. The system permits manual data entry into an electronic worksheet of test measurements and results.
t. The system allows incorrectly inputted data to be manually corrected.
u. The system prevents out-of-range and other critical results from being posted as final.
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.
w. The system allows automated or semi-automated data insertion.
x. The system stores non-narrative textual results in searchable fields.

1.4.5 Post-analysis and validation

1.4.5 Post-analysis and validation
Request for information Requirement code Vendor response
a. The system updates sample/item status when tests are completed.
b. The system automatically reorders a test or orders additional tests if results don't meet lab-defined criteria, especially when the original sample is still available.
c. The system reads results from previously entered tests to calculate a final result and immediately displays the calculated result.
d. The system allows authorized users to review all analytical results, including pricing, spec violations, history or trend analysis by analyte, and comments.
e. The system graphically displays the results of one or more tests in a graph (normalized or otherwise) for the purpose of visualizing data or searching for possible trends.
f. The system allows on-screen review of the stored test result, diluted result with corrected method detection limits (MDLs), and qualifiers after running samples for multiple dilutions as in gas chromatography–mass spectrometry (GC-MS).
g. The system includes data mining tools for model learning, evaluation, and usage.
h. The system displays the standard operating procedure (SOP) associated with each test result to ensure proper techniques were used.
i. The system stores test-related analysis comments with the test.
j. The system provides auto-commenting for common laboratory result comments.
k. The system is capable of displaying entered order and test comments as an onscreen alert for testing and other personnel.
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.
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.
n. The system's results validation process checks each result against its individual sample location specifications (both warning and specification limits).
o. The system supports validation at the analysis and sample level, while also prohibiting sample validation when analysis validation is incomplete.
p. The system uses a menu-driven process for results validation.
q. The system provides secure electronic peer review of results.
r. The system clearly differentiates released preliminary data from fully validated results.
s. The system validates/approves data prior to being moved to the main database.
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.
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.
v. The system provides a base for a quality assurance program, including proficiency testing, scheduled maintenance of equipment, etc.
w. The system distinguishes QA/QC duplicates from normal samples.
x. The system allows QA/QC tests to be easily created and associated with the primary analytical test.
y. The system allows manual entry of QA and QC data not captured as part of the system's regular processes.
z. The system calculates monthly QA/QC percentages for testing.
aa. The system automatically flags out-of-range quality control limits.
ab. The system is able to flag results for aspects other than being out-of-range, including testing location, test subject age, etc.
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.

1.4.6 Instruments

1.4.6 Instruments
Request for information Requirement code Vendor response
a. The system bilaterally interfaces with instruments and related software.
b. The system downloads data directly from laboratory instruments.
c. The system permits the defining and exporting of sequences to instruments.
d. The system tracks and reports on the usage of attached laboratory instruments.
e. The system allows automatic or manual reservation/scheduling of laboratory instruments.
f. The system automatically (or manually allow an authorized user to) removes an instrument from potential use when it falls out of tolerance limit or requires scheduled calibration.
g. The system provides a database of preventative maintenance, calibration, and repair records for laboratory equipment, preferably supported by standardized reporting.
h. The system schedules calibration, verification, and maintenance tasks in the worksheets or work flow process and make that schedule available for viewing.
i. The system allows users to create and edit instrument maintenance profiles.

1.4.7 External system interfaces

1.4.7 External system interfaces
Request for information Requirement code Vendor response
a. The system supports a library of common electronic data deliverable (EDD) formats.
b. The system transfers data to and from another record management system.
c. The system integrates with Microsoft Exchange services.
d. The system imports data from and exports data to Microsoft Word, Excel, and/or Access.
e. The system can interface with non-Microsoft programs.
f. The system interfaces with external billing systems.
g. The system interfaces with enterprise resource planning (ERP) systems.
h. The system interfaces with external contract or reference laboratories to electronically send or retrieve datasheets, analysis reports, and other related information.
i. The system exchanges data with National Identification System (NAIS) tracking systems.
j. The system generates and exchanges data with other systems using Health Level 7 (HL7) standards.
k. The system leverages the application programming interface (API) of other systems to establish integration between systems.
l. The system provides a real-time interface for viewing live and stored data transactions and errors generated by interfaced instruments and systems.
m. The system transmits status changes of specimens, inventory, equipment, etc. to an external system.
n. The system directs output from ad-hoc queries to a computer file for subsequent analysis by other software.
o. The system supports the manual retransmission of data to interfaced systems.
p. The system supports dockable mobile devices and handle information exchange between them and the system.
q. The system supports the use of optical character recognition (OCR) software.

1.4.8 Reporting

1.4.8 Reporting
Request for information Requirement code Vendor response
a. The system includes a versatile report writer and forms generator that can generate reports from any data in tables.
b. The system includes a custom graphic generator for forms.
c. The system interfaces with a third-party reporting application.
d. The system allows the development of custom templates for different types of reports.
e. The system maintains template versions and renditions, allowing management and tracking of the template over time.
f. The system generates template letters for semi-annual reports.
g. The system supports report queries by fields/keys, status, completion, or other variables.
h. The system use Microsoft Office tools for formatting reports.
i. The system supports multiple web browsers for viewing online reports.
j. The system generates, stores, reproduces, and displays laboratory, statistical, and inventory reports on demand, including narrative.
k. The system includes several standard reports and query routines to access all specimens with the pending status through a backlog report that includes the following criteria: all laboratory, department, analysis, submission date, collection date, prep test complete, location, project, specimen delivery group, and other user-selectable options.
l. The system indicates whether a report is preliminary, amended, corrected, or final while retaining revision history.
m. The system supports both structured and synoptic reporting.
n. The system generates management and turn-around time reports and graphs.
o. The system generates customized final reports.
p. The system automatically generates laboratory reports of findings and other written documents.
q. The system automatically generates individual and aggregate workload and productivity reports on all operational and administrative activities.
r. The system automatically generates and transmits exception trails and exception reports for all entered and/or stored out-of-specification data.
s. The system generates a read-only progress report that allows for printed reports of specimen status and data collected to date.
t. The system provides an ad-hoc web reporting interface to report on user-selected criteria.
u. The system automatically generates and updates control charts.
v. The system generates QA/QC charts for all recovery, precision, and lab control specimens via a full statistics package, including Levy-Jennings plots and Westgard multi-rule.
w. The system displays history of previous results for an analyte's specimen point in a tabular report, graphic trend chart, and statistical summary.
x. The system automatically generates and posts periodic static summary reports on an internal web server.
y. The system transmits results in a variety of ways including fax, e-mail, print, and website in formats like RTF, PDF, HTML, XML, DOC, XLS, and TXT.
z. The system electronically transmits results via final report only when all case reviews have been completed by the case coordinator.
aa. The system includes a rules engine to determine the recipients of reports and other documents based on definable parameters.
ab. The system allows database access using user-friendly report writing and inquiry tools.

1.4.9 Laboratory management

1.4.9 Laboratory management
Request for information Requirement code Vendor response
a. The system allows the creation, modification, and duplication of user profiles.
b. The system allows entry, maintenance, and administration of customers, suppliers, and other outside entities.
c. The system allows customers, suppliers, and other such entities to be flagged as either active or inactive.
d. The system allows the creation, modification, and maintenance of user training records and associated training materials.
e. The system supports the ability to set up separate security, inventory, reporting, etc. profiles across multiple facilities.
f. The system allows the management of information workflow, including notifications for requests and exigencies.
g. The system allows the management of documents like SOPs, MSDS, etc. to better ensure they are current and traceable.
h. The system allows the management and monitoring of resources by analyst, priority, analysis, and instrument.
i. The system allows authorized persons to select and assign tasks by analysts, work group, instrument, test, sample, and priority.
j. The system allows authorized persons to review unassigned work by discipline and by lab.
k. The system allows authorized persons to review pending work by analyst prior to assigning additional work.
l. The system manages and reports on reference samples, reagents, and other inventory, including by department.
m. The system automatically warns specified users when inventory counts reach a definable threshold and either prompt for or process a reorder.
n. The system allows authorized users to monitor and report on reference and reagent creation, use, and expiration.
o. The system allows authorized users to search invoice information by invoice number, account number, accession, payment types, client, or requested diagnostic test(s).
p. The system includes performance assessment tracking.
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.
r. The system includes an incident tracking system for recording, investigating, and managing safety and accident violations in the laboratory.
s. The system monitors proficiency test assignment, completion, and casework qualification for analytical staff.
t. The system includes revenue management functionality, including profitability analysis.
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.
v. The system calculates administrative and lab costs.
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.
x. The system supports multiple customer payment sources (e.g. grants).
y. The system tracks number of visits per specific industry.

1.5 System-specific

The system-specific addendum can be found here.

1.6 Industry-specific

The industry-specific addendum can be found here.

1.7 Custom requirements

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