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| | type = notice | | | type = notice |
| | style = width: 960px; | | | style = width: 960px; |
| | text = This is my sandbox, where I play with features and test MediaWiki code. If you wish to leave a comment for me, please see [[User_talk:Shawndouglas|my discussion page]] instead.<p></p> | | | text = This is my primary sandbox page, where I play with features and test MediaWiki code. If you wish to leave a comment for me, please see [[User_talk:Shawndouglas|my discussion page]] instead.<p></p> |
| }} | | }} |
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| ==Sandbox begins below== | | ==Sandbox begins below== |
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| ==1.0 Vendor information==
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| {|
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| | STYLE="vertical-align:top;"|
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| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
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| ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px; width:800px;"| 1.0 '''Vendor information'''
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| | style="padding:5px; width:200px;" |'''Company name'''
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| | style="background-color:white; padding:5px; width:600px;" |
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| | style="padding:5px; width:200px;" |'''Physical address'''
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| | style="background-color:white; padding:5px; width:600px;" |
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| | style="padding:5px; width:200px;" |'''Website'''
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| | style="background-color:white; padding:5px; width:600px;" |
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| | style="padding:5px; width:200px;" |'''LIMSwiki web page'''
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| | style="background-color:white; padding:5px; width:600px;" |
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| | style="padding:5px; width:200px;" |'''Contact name and title'''
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| | style="background-color:white; padding:5px; width:600px;" |
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| | style="padding:5px; width:200px;" |'''Contact e-mail'''
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| | style="background-color:white; padding:5px; width:600px;" |
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| | style="padding:5px; width:200px;" |'''Contact phone and fax'''
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| | style="background-color:white; padding:5px; width:600px;" |
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| | style="padding:5px; width:200px;" |'''Years in business'''
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| | style="background-color:white; padding:5px; width:600px;" |
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| |-
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| |}
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| |}
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| ==1.1 Vendor services==
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| {|
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| | STYLE="vertical-align:top;"|
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| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
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| ! colspan="3" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"| 1.1 '''Vendor services'''
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| |-
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| ! style="color:brown; background-color:#ffffee; width:500px;"| Request for information
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| ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
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| ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
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| |-
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| | style="padding:5px; width:500px;" |'''a.''' The vendor offers an online and/or on-site demonstration.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| | 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.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''c.''' The vendor explains their overall project approach, deliverables, time constraints, and any other criteria for the project.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| | 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.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| | 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.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| | 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.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| | style="padding:5px; width:500px;" |'''g.''' The vendor provides a support schedule for the implementation process, including optional support levels, their function, and availability.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| | 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.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''i.''' The vendor provides a gap analysis after initial system installation, identifying the deliverables or tasks remaining.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| | style="padding:5px; width:500px;" |'''j.''' The vendor provides a table linking each deliverable to the corresponding user requirement specification it fulfills.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''k.''' The vendor uses a consistent training methodology for educating new users.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| | style="padding:5px; width:500px;" |'''l.''' The vendor supplies [[Laboratory information system|LIS]]-specific training program curricula.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| | style="padding:5px; width:500px;" |'''m.''' The vendor provides user, administrator, developer, installation, and reference manuals.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| | style="padding:5px; width:500px;" |'''n.''' The vendor provides design qualification documentation.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| | style="padding:5px; width:500px;" |'''o.''' The vendor provides installation qualification documentation.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| | style="padding:5px; width:500px;" |'''p.''' The vendor provides operation qualification documentation.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| | style="padding:5px; width:500px;" |'''q.''' The vendor provides performance qualification documentation during implementation.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| | style="padding:5px; width:500px;" |'''r.''' The vendor provides well-documented system upgrades that authorized users can independently install.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| | style="padding:5px; width:500px;" |'''s.''' The vendor provides source code for the system.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| | style="padding:5px; width:500px;" |'''t.''' The vendor provides an optional comprehensive set of test codes suitable for use by the purchaser.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
| |
| |}
| |
| |}
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|
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| ==1.2 Information technology==
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| {|
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| | STYLE="vertical-align:top;"|
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| ===1.2.1 General IT===
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| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
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| |-
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| ! colspan="3" style="color:DarkSlateGray; text-align:left; padding-left:40px;"| 1.2.1 '''General IT'''
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| |-
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| ! style="color:brown; background-color:#ffffee; width:500px;"| Request for information
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| ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
| |
| ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
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| |-
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| | 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.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| | 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.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| | style="padding:5px; width:500px;" |'''c.''' The system contains a single, centralized database that supports multiple sites and departments.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| | style="padding:5px; width:500px;" |'''d.''' The system's database conforms to the [[ODBC|Open Database Connectivity Standard]] (ODBC).
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| | 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.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''f.''' The system is designed to not be impacted by multiple users or failover processes.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''g.''' The system applies security features to all system files.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''h.''' The system applies log-in security to all servers and workstations accessing it.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''i.''' The system provides a workstation and server authentication mechanism.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''j.''' The system applies Secured Socket Layer (SSL) encryption on the web client interface.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''k.''' The system encrypts client passwords in a database, with support for multi-case and special characters.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''l.''' The system uses TCP/IP as its network transport.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | 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;" |
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| | style="background-color:white;" |
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| | style="padding:5px; width:500px;" |'''n.''' The system allows automated backup and restore capability without support intervention, as well as manual backups.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''o.''' The system maintains the transactional history of system administrators.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''p.''' The system maintains an analyst communication log, accessible by the administrator.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| |}
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| ===1.2.2 Hardware environment===
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| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
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| ! colspan="3" style="color:DarkSlateGray;text-align:left; padding-left:40px;"| 1.2.2 '''Hardware environment'''
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| ! style="color:brown; background-color:#ffffee; width:500px;"| Request for information
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| ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
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| ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
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| |-
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| | style="padding:5px; width:500px;" |'''a.''' The system proves compatible with a variety of hardware environments.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| | style="padding:5px; width:500px;" |'''b.''' The system can be utilized with a touch-screen.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| |}
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| ===1.2.3 Software environment===
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| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
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| ! colspan="3" style="color:DarkSlateGray;text-align:left; padding-left:40px;"| 1.2.3 '''Software environment'''
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| ! style="color:brown; background-color:#ffffee; width:500px;"| Request for information
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| ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
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| ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
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| |-
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| | style="padding:5px; width:500px;" |'''a.''' The system proves compatible with a variety of software environments.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| | style="padding:5px; width:500px;" |'''b.''' The system utilizes a non-proprietary database such as Oracle or Microsoft SQL Server.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| |}
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| |}
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|
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| ==1.3 Regulatory compliance and security==
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| {|
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| | STYLE="vertical-align:top;"|
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| ===1.3.1 Regulatory compliance===
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| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
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| ! colspan="3" style="color:DarkSlateGray; text-align:left; padding-left:40px;"| 1.3.1 '''Regulatory compliance'''
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| |-
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| ! style="color:brown; background-color:#ffffee; width:500px;"| Request for information
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| ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
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| ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
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| |-
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| | 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.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| | style="padding:5px; width:500px;" |'''b.''' The system supports [[ISO/IEC 17025]] requirements.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| | style="padding:5px; width:500px;" |'''c.''' The system supports [[HIPAA]] requirements.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| | style="padding:5px; width:500px;" |'''d.''' The system supports [[GALP]] and/or [[GAMP]] standards.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| | style="padding:5px; width:500px;" |'''e.''' The system supports the standards of [[The NELAC Institute]].
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| | style="padding:5px; width:500px;" |'''f.''' The system supports AABB (American Association of Blood Banks), College of American Pathologists, (CAP), The Joint Commission (TJC), and/or any additional requirements or standards.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| | style="padding:5px; width:500px;" |'''g.''' The system meets government requirements for handling classified information and documents.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| | style="padding:5px; width:500px;" |'''h.''' The system can create reports for and route samples to the [[Centers for Disease Control and Prevention]] (CDC), Food and Drug Administrations (FDA), Environmental Protection Agency (EPA), and other contract laboratories.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| | style="padding:5px; width:500px;" |'''i.''' 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.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| | style="padding:5px; width:500px;" |'''j.''' The system maintains audit trails at least as long as the records to which they pertain.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| | style="padding:5px; width:500px;" |'''k.''' The system's audit log retains all data, prohibits any deletions, allows user comments, and allows reporting of contained information.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| | style="padding:5px; width:500px;" |'''l.''' The system provides additional persistent auditing capabilities, such as the audit of cancelled tests and scheduled system functions.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| | style="padding:5px; width:500px;" |'''m.''' 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.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| | style="padding:5px; width:500px;" |'''n.''' The system provides the ability to insert/manage secure [[ELN feature#Electronic signatures|electronic]] and/or digital signatures.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''o.''' The system incorporates automatic date and time stamping of additions, changes, etc.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''p.''' The system can automatically validate and approve data prior to being moved to the main database.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
| |
| |}
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|
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| ===1.3.2 Security===
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| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
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| ! colspan="3" style="color:DarkSlateGray;text-align:left; padding-left:40px;"| 1.3.2 '''Security'''
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| |-
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| ! style="color:brown; background-color:#ffffee; width:500px;"| Request for information
| |
| ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
| |
| ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
| |
| |-
| |
| | 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.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''b.''' The system allows administrators and users to reset user passwords.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''c.''' The system features and enforces adjustable rules concerning password complexity, reuse, and expiration.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''d.''' The system can lock a user out after a specified number of consecutive failed log-in attempts.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''e.''' The system provides the option for automatic user logout based on keyboard or mouse inactivity.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
| |
| | style="padding:5px; width:500px;" |'''f.''' The system makes authority checks to ensure only authorized individuals can use the system to perform an operation.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''g.''' The system allows authorized users to modify records, while also maintaining an audit trail of such actions.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| |}
| |
| |}
| |
|
| |
| ==1.4 General system functions==
| |
| {|
| |
| | STYLE="vertical-align:top;"|
| |
| ===1.4.1 General functions===
| |
| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
| |
| |-
| |
| ! colspan="3" style="color:DarkSlateGray; text-align:left; padding-left:40px;"| 1.4.1 '''General functions'''
| |
| |-
| |
| ! style="color:brown; background-color:#ffffee; width:500px;"| Request for information
| |
| ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
| |
| ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''a.''' The system offers non-LIS 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''w.''' The system [[LIS 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''ab.''' The system includes clinical trial management tools.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''ac.''' The system can handle [[LIS feature#Patient and case management|patient case management]] and assignment.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''ad.''' The system provides physician, clinic, and contract lab management tools.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''ae.''' The system provides outreach and call list management tools.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''af.''' The system supports multi-site, multi-lab, or multi-physician groups.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''ag.''' The system provides disease tracking functionality.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''ah.''' The system monitors turnaround time, from test request to clinician review.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''ai.''' The system is veterinary-compatible.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| |}
| |
|
| |
| ===1.4.2 Configuration and customization===
| |
| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
| |
| |-
| |
| ! colspan="3" style="color:DarkSlateGray;text-align:left; padding-left:40px;"| 1.4.2 '''Configuration and customization'''
| |
| |-
| |
| ! style="color:brown; background-color:#ffffee; width:500px;"| Request for information
| |
| ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
| |
| ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''e.''' The system supports [[LIS 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''g.''' The system permits users to create templates and worksheets for standardizing analysis pages, patient pages, test ordering pages, and/or the reporting processes.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''h.''' 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;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''i.''' The system allows a user to independently add universal fields on all specimens 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;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''j.''' The system provides flexible and customizable mapping dictionaries for interconversion of different standards and more.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''k.''' The system supports the definition and maintenance of edit tables and lists.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''l.''' The system supports customizable test, panel, and profile libraries.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''m.''' The system supports customization of test pick lists based on specialty utilization.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''n.''' The system dynamically changes captions (labels) on system fields.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''o.''' The system has dynamically configurable limit periods and notification hierarchy.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''p.''' The system provides optional configuration choices for correctional facilities.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''q.''' The system provides optional configuration choices for [[biobank]]s and blood banks.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''r.''' 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;" |
| |
| |-
| |
| |}
| |
|
| |
| ===1.4.3 Receiving and scheduling===
| |
| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
| |
| |-
| |
| ! colspan="3" style="color:DarkSlateGray;text-align:left; padding-left:40px;"| 1.4.3 '''Receiving and scheduling'''
| |
| |-
| |
| ! style="color:brown; background-color:#ffffee; width:500px;"| Request for information
| |
| ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
| |
| ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
| |
| |-
| |
| | 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 [[LIS 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 specimen 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'' ([[LIS feature#Sample and result batching|batch]]) login without requiring additional programming.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''g.''' The system features order entry rules for better managing duplicate orders, rejecting inappropriate tests, identifying inappropriate containers, rerouting tests to outside labs, etc.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''h.''' The system supports the modification of specimen or specimen batch information prior to actual ''multi-specimen'' (batch) login.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''i.''' The system supports ad-hoc specimens not predefined in the specimen point list during ''multi-specimen'' (batch) login.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''j.''' The system creates, saves, and recalls pre-login groups for routine specimens to simplify recurring logins.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''k.''' The system streamlines the [[LIS feature#Sample login and management|login]] of recurring specimen projects.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''l.''' The system allows standing orders and test schedules to be defined for future orders.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''m.''' The system automatically [[LIS feature#Label support|generates labels]] for recurring specimens and specimen groups.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''n.''' The system can automatically split and manage orders requiring multiple testing locations.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''o.''' The system can differentiate "investigation use only" and "research use only" tests.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''p.''' The system can automatically generate and manage administrative documents for genetics tests.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''q.''' The system allows authorized users to generate user-definable or rules-based chain of custodies, worksheets, routing sheets, and custom labels upon specimen login.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''r.''' The system provides a comprehensive view of all specimens and projects in the system using a color-coded status view of the current and scheduled specimens via user-configurable templates, all without requiring additional programming.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''s.''' The system includes [[LIS feature#Environmental monitoring|environmental monitoring]] (EM) functionality or integrate with an external EM product.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''t.''' The system prevents a specimen from being placed in a report queue until approved.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''u.''' The system includes comprehensive [[LIS feature#Task and event scheduling|scheduling]], [[LIS feature#Sample tracking|tracking]], and [[LIS feature#Workflow management|flow management]] of specimens, including across multiple sites.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''v.''' The system is capable of geographically organizing specimen records and their associated tests for special analysis and reporting.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''w.''' The system allows authorized users to accept, cancel, re-run, and override attributes of one or multiple tests for a given patient.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''x.''' 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;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''y.''' The system allows multiple diagnosis codes to be attached to an ordered test.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''z.''' 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;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''aa.''' The system automatically runs medical necessity checks (based on diagnosis codes) on a requested test.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''ab.''' The system automatically makes duplicate order checks and notifies applicable users upon detection.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''ac.''' The system can import and utilize the [[Centers for Medicare and Medicaid Services]]' (CMS') National and Local Coverage Determinations files.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''ad.''' The system can track and manage advance beneficiary notices (ABNs) from CMS as needed.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''ae.''' The system allows authorized users to schedule routine specimens 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;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''af.''' The system generates an hourly, daily, weekly, or monthly specimen collection schedule from a scheduling database.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''ag.''' The system schedules and [[LIS feature#Project and/or task management|assign tasks]] based on available inventory and personnel.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''ah.''' The system supports automatic assignment and scheduling of [[LIS feature#Data and trend analysis|analysis requests]].
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''ai.''' The system receives accession/analysis request information from web-enabled forms.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''aj.''' 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;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''ak.''' The system can capture and store patient demographics, risk factors, and epidemiology data such as exposure data from third-party test requests.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''al.''' The system has an inter-lab transfer function.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''am.''' The system processes automated uploading of field-derived specimen collection data.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''an.''' 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;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''ao.''' The system supports tracking of shipping and receiving.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| |}
| |
|
| |
| ===1.4.4 Analysis and data entry===
| |
| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
| |
| |-
| |
| ! colspan="3" style="color:DarkSlateGray;text-align:left; padding-left:40px;"| 1.4.4 '''Analysis and data entry'''
| |
| |-
| |
| ! style="color:brown; background-color:#ffffee; width:500px;"| Request for information
| |
| ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
| |
| ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''f.''' The system limits test code authorization to only qualified personnel and maintain their certification(s) to run assigned tests.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''g.''' The system supports and qualifies text-based tests.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''k.''' The system can effectively manage genetic testing protocols.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''l.''' The system can effectively manage histology and cytology testing protocols.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''m.''' The system allows for user-definable and procedure-specific protocols for HIV specimens.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''n.''' 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;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''o.''' The system distinguishes between routine and duplicate analysis.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''p.''' 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;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''q.''' The system notifies analysts of applicable safety hazards associated with a specimen, reagent, or test before testing begins.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''r.''' The system electronically transfers an item during testing from one functional area to another.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''s.''' The system's user interface displays visual indicators such as status icons to indicate a specimen's status in the workflow.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''t.''' 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;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''u.''' The system permits [[LIS 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;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''v.''' 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;" |'''w.''' 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;" |'''x.''' The system provides colored visual indication of previously entered data as well as new data associated with a single specimen 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;" |'''y.''' The system allows automated or semi-automated data insertion.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''z.''' The system stores non-narrative textual results in searchable fields.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| |}
| |
|
| |
| ===1.4.5 Post-analysis and validation===
| |
| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
| |
| |-
| |
| ! colspan="3" style="color:DarkSlateGray;text-align:left; padding-left:40px;"| 1.4.5 '''Post-analysis and validation'''
| |
| |-
| |
| ! style="color:brown; background-color:#ffffee; width:500px;"| Request for information
| |
| ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
| |
| ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''a.''' The system updates specimen/item status when tests are completed.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | 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 specimen is still available.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''c.''' The system can record test results in or map them to the Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT) and/or Logical Observation Identifiers Names and Codes (LOINC) standards.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''d.''' 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;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''e.''' 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;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''f.''' 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;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''g.''' The system provides tools for graphical patient and analyte trend plotting.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''h.''' 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;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''i.''' The system includes data mining tools for model learning, evaluation, and usage.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''j.''' 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;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''k.''' The system stores test-related analysis comments with the test.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''l.''' The system provides auto-commenting for common laboratory result comments.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''m.''' 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;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''n.''' 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;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''o.''' The 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="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''p.''' 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;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''q.''' 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;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''r.''' The system uses a menu-driven process for results validation.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''s.''' The system provides secure electronic peer review of results.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''t.''' The system clearly differentiates released preliminary data from fully validated results.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''u.''' The system validates/approves data prior to being moved to the main database.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''v.''' The system can hold all test results on a specimen 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;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''w.''' 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;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''x.''' 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;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''y.''' The system distinguishes QA/QC duplicates from normal samples.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''z.''' 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;" |'''aa.''' 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;" |'''ab.''' The system calculates monthly QA/QC percentages for testing.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''ac.''' 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;" |'''ad.''' The system is able to flag results for aspects other than being out-of-range, including testing location, patient age, etc.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''ae.''' The system is able to automatically report any diagnostic test results deemed "suspect" or "positive" for reportable diseases.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''af.''' 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;" |
| |
| |-
| |
| |}
| |
|
| |
| ===1.4.6 Instruments===
| |
| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
| |
| |-
| |
| ! colspan="3" style="color:DarkSlateGray;text-align:left; padding-left:40px;"| 1.4.6 '''Instruments'''
| |
| |-
| |
| ! style="color:brown; background-color:#ffffee; width:500px;"| Request for information
| |
| ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
| |
| ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''a.''' The system bilaterally [[LIS feature#Instrument interfacing and management|interfaces with instruments]] and related software.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''b.''' The system downloads data directly from laboratory instruments.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| |}
| |
|
| |
| ===1.4.7 External system interfaces===
| |
| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
| |
| |-
| |
| ! colspan="3" style="color:DarkSlateGray;text-align:left; padding-left:40px;"| 1.4.7 '''External system interfaces'''
| |
| |-
| |
| ! style="color:brown; background-color:#ffffee; width:500px;"| Request for information
| |
| ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
| |
| ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''d.''' The system [[LIS 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;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''e.''' The system can interface with non-Microsoft programs.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''f.''' The system interfaces with external billing systems.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''g.''' The system interfaces with [[electronic medical record]] or [[electronic health record]] systems.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''h.''' The system interfaces with [[hospital information system]]s.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''i.''' The system interfaces with enterprise resource planning (ERP) systems.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''j.''' 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;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''k.''' The system exchanges data with National Identification System (NAIS) tracking systems.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''l.''' 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;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''m.''' 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;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''n.''' 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;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''o.''' The system transmits status changes of specimens, inventory, equipment, etc. to an external system.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''p.''' 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;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''q.''' The system supports the manual retransmission of data to interfaced systems.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''r.''' The system supports [[LIS 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;" |'''s.''' The system supports the use of optical character recognition (OCR) software.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| |}
| |
|
| |
| ===1.4.8 Reporting===
| |
| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
| |
| |-
| |
| ! colspan="3" style="color:DarkSlateGray;text-align:left; padding-left:40px;"| 1.4.8 '''Reporting'''
| |
| |-
| |
| ! style="color:brown; background-color:#ffffee; width:500px;"| Request for information
| |
| ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
| |
| ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''d.''' The system allows the development of [[LIS feature#Configurable templates and forms|custom templates]] for different types of reports.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''o.''' The system generates customized final reports.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''u.''' The system automatically generates and updates control charts.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''ac.''' The system supports automatic reporting to the state based on state-level health department rules.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''ad.''' The system reports molecular results in both clinical and anatomical pathology environments.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''ae.''' The system can produce specialized reports for microbiology, hematology, assay trend, and/or cardiac risk.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''af.''' The system can produce epidemiology and antibiogram reports.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''ag.''' The system provides the tools for creating and maintaining licensing, proficiency testing, inspection, and regulatory records and reports.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| |}
| |
|
| |
| ===1.4.9 Laboratory management===
| |
| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
| |
| |-
| |
| ! colspan="3" style="color:DarkSlateGray;text-align:left; padding-left:40px;"| 1.4.9 '''Laboratory management'''
| |
| |-
| |
| ! style="color:brown; background-color:#ffffee; width:500px;"| Request for information
| |
| ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
| |
| ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
| |
| |-
| |
| | 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;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''b.''' The system allows entry, maintenance, and administration of patient records and is able to track multiple patient encounters.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''c.''' The system allows entry, maintenance, and administration of [[LIS feature#Customer, supplier, and physician management|customers]], suppliers, and other outside entities.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''d.''' The system allows patients, customers, suppliers, physicians, and other such entities to be flagged as either active or inactive.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''e.''' The system allows the creation, modification, and maintenance of user [[LIS feature#Performance evaluation|training records]] and associated training materials.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''f.''' 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;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''g.''' The system allows the management of information workflow, including notifications for requests and exigencies.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''h.''' The system allows the [[LIS 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;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''i.''' 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;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''j.''' The system allows authorized persons to select and assign tasks by analysts, work group, instrument, test, specimen, and priority.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''k.''' The system allows authorized persons to review unassigned work by discipline and by lab.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''l.''' 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;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''m.''' The system manages and reports on reference specimens, reagents, and other inventory, including by department.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''n.''' The system automatically warns specified users when [[LIS 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;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''o.''' 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;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''p.''' The system allows authorized users to search [[LIS 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;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''q.''' The system includes [[LIS feature#Performance evaluation|performance assessment]] tracking.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''r.''' 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;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''s.''' 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;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''t.''' The system monitors proficiency test assignment, completion, and casework qualification for analytical staff.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''u.''' The system includes revenue management functionality, including medical necessity checks and profitability analysis.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''v.''' 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;" |'''w.''' The system calculates administrative and lab costs.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''x.''' 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;" |'''y.''' 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;" |'''z.''' The system supports multi-tiered pricing based on patient type and location.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''aa.''' The system tracks number of visits per specific industry.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| |}
| |
| |}
| |
|
| |
| ==1.5 Custom requirements==
| |
| {|
| |
| | STYLE="vertical-align:top;"|
| |
| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
| |
| |-
| |
| ! colspan="3" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px; width:1300px;"| 1.7 '''Custom requirements'''
| |
| |-
| |
| ! style="color:brown; background-color:#ffffee; width:470px;"| Request for information
| |
| ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
| |
| ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
| |
| |-
| |
| | style="padding:15px; width:470px;" |'''a.'''
| |
| | style="background-color:white; padding:15px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:15px; width:470px;" |'''b.'''
| |
| | style="background-color:white; padding:15px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:15px; width:470px;" |'''c.'''
| |
| | style="background-color:white; padding:15px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:15px; width:470px;" |'''d.'''
| |
| | style="background-color:white; padding:15px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:15px; width:470px;" |'''e.'''
| |
| | style="background-color:white; padding:15px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:15px; width:470px;" |'''f.'''
| |
| | style="background-color:white; padding:15px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:15px; width:470px;" |'''g.'''
| |
| | style="background-color:white; padding:15px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:15px; width:470px;" |'''h.'''
| |
| | style="background-color:white; padding:15px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:15px; width:470px;" |'''i.'''
| |
| | style="background-color:white; padding:15px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:15px; width:470px;" |'''h.'''
| |
| | style="background-color:white; padding:15px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:15px; width:470px;" |'''i.'''
| |
| | style="background-color:white; padding:15px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:15px; width:470px;" |'''j.'''
| |
| | style="background-color:white; padding:15px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| |}
| |
| |}
| |
