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<div class="nonumtoc">__TOC__</div>
{{Saved book
These addendums to the [[User:Shawndouglas/sandbox#System questionnaire|primary system questionnaire]] cover system-specific laboratory requirements not common to the [[laboratory information management system]].
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'''NOTE''': These addendums are meant to represent ''additional'' user requirement specs unique to the system and not represented in the primary system questionnaire.
== LIS User Requirements for the Physician Office Laboratory (POL) ==
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;Chapter 1 Introduction
:[[Clinical laboratory]]
:[[Health informatics]]
;Chapter 2 The Physician Office Laboratory (POL)
:[[Physician office laboratory]]
:[[LII:The Practical Guide to the U.S. Physician Office Laboratory]]
;Chapter 3 Defining LIS Requirements with the LIMSpec
:[[LIS feature]]
:[[Clinical Laboratory Improvement Amendments]]
:[[Health Insurance Portability and Accountability Act]]
;Chapter 4 Example LIMSpec for the Physician Office Lab
:[[POL Registration/accession|Registration/Accession]]
:[[POL Assays|Assays]]
:[[POL Data entry|Data Entry]]
:[[POL Reporting|Reporting]]
:[[POL Compliance|Compliance]]
:[[POL Interfacing|Interfacing]]
:[[POL System|System]]
:[[POL General|General]]
:[[POL Functions - General]]
;Chapter 5 LIS Products for the Physician Office Lab
:[[Vendor:Apex HealthWare, LLC|Apex HealthWare, LLC]]
:[[Vendor:CompuGroup Medical AG|CompuGroup Medical AG]]
:[[Vendor:J&S Medical Associates, Inc.|J&S Medical Associates, Inc.]]
:[[Vendor:Orchard Software Corporation|Orchard Software Corporation]]
:[[Schuyler House]]


==1.5 System-specific==
<!--Place all category tags here-->
{|
| STYLE="vertical-align:top;"|
===1.5a [[Laboratory information system]]===
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="3" style="color:DarkSlateGray; text-align:left; padding-left:40px;"| 1.5a.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.''' Does your system include clinical trial management tools? If so, elaborate.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''b.''' Does your system provide patient case management and assignment?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''c.''' Does your system provide physician, clinic, and contract lab management tools?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''d.''' Does your system provide outreach and call list management tools?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''e.''' Does your system provide multi-site and multi-lab management tools?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''f.''' Does your system provide disease tracking functionality?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''g.''' Does your system monitor turnaround time, from test request to clinician review?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''h.''' Is your system veterinary compatible?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
|}
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="3" style="color:DarkSlateGray; text-align:left; padding-left:40px;"| 1.5a.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.''' Does your system permit 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;" |'''b.''' Does your system provide 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;" |'''c.''' Does your system support customizable test, panel, and profile libraries?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''d.''' Does your system support provisions for correctional facilities?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''e.''' Does your system support customization of test pick lists based on specialty utilization?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
|}
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="3" style="color:DarkSlateGray; text-align:left; padding-left:40px;"| 1.5a.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.''' Does your system allow users to create, manage, and track viewable sample container schemata?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''b.''' Does your system feature 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;" |'''c.''' Does your system automatically split and manage orders requiring multiple testing locations?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''d.''' Does your system create and manage administrative documents for genetics testing?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''e.''' Does your system allow 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;" |'''f.''' Can your system import and utilize the Centers for Medicare & Medicaid Services' (CMS') National and Local Coverage Determinations files?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''g.''' Does your system 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;" |'''h.''' Can your system differentiate "investigation use only" and "research use only" tests?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
|}
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="3" style="color:DarkSlateGray; text-align:left; padding-left:40px;"| 1.5a.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.''' Does your system effectively manage complex molecular protocols? Explain.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''b.''' Does your system effectively manage genetic testing protocols? Explain.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''c.''' Does your system effectively manage histology and cytology protocols? Explain.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''d.''' Does your system allow for user-definable and procedure-specific protocols for HIV specimens? Explain.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''e.''' Does your system effectively manage biobanking and blood banking activities and the data associated with them? Explain.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
|}
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="3" style="color:DarkSlateGray; text-align:left; padding-left:40px;"| 1.5a.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.''' Does your system include data mining tools for model learning, evaluation, and usage?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''b.''' Does your system report molecular results in both clinical and anatomical pathology environments?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''c.''' Does your system provide tools for graphical patient and analyte trend plotting?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''d.''' Can your system 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;" |
|-
|}
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="3" style="color:DarkSlateGray; text-align:left; padding-left:40px;"| 1.5a.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.''' No LIS-specific instrument requirements as of yet
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
|}
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="3" style="color:DarkSlateGray; text-align:left; padding-left:40px;"| 1.5a.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.''' Can your system interface with a [[hospital information system]]?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''b.''' Can your system interface with an [[electronic medical record]] or [[electronic health record]] system?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''c.''' Can your system interface with reference laboratories? If so, explain how.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
|}
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="3" style="color:DarkSlateGray; text-align:left; padding-left:40px;"| 1.5a.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.''' Does your system include a ''synoptic'' reporting module?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''b.''' Does your system 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;" |'''c.''' Does your system produce epidemiology and antibiogram reports?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
|}
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="3" style="color:DarkSlateGray; text-align:left; padding-left:40px;"| 1.5a.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.''' Does your system include revenue management functionality, including medical necessity checks and profitability analysis?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
|}
===1.5b [[Electronic laboratory notebook]]===
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="3" style="color:DarkSlateGray; text-align:left; padding-left:40px;"| 1.5b.1 '''Electronic laboratory notebook'''
|-
  ! 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.''' Enter your own unique function here
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
|}
===1.5c [[Chromatography data management system|Chromatography]] and [[scientific data management system]]===
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="3" style="color:DarkSlateGray; text-align:left; padding-left:40px;"| 1.5c.1 '''Chromatography and scientific data management system'''
|-
  ! 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.''' Enter your own unique function here
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
|}
|}

Latest revision as of 20:23, 11 April 2024


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LIS User Requirements for the Physician Office Laboratory (POL)

Chapter 1 Introduction
Clinical laboratory
Health informatics
Chapter 2 The Physician Office Laboratory (POL)
Physician office laboratory
LII:The Practical Guide to the U.S. Physician Office Laboratory
Chapter 3 Defining LIS Requirements with the LIMSpec
LIS feature
Clinical Laboratory Improvement Amendments
Health Insurance Portability and Accountability Act
Chapter 4 Example LIMSpec for the Physician Office Lab
Registration/Accession
Assays
Data Entry
Reporting
Compliance
Interfacing
System
General
POL Functions - General
Chapter 5 LIS Products for the Physician Office Lab
Apex HealthWare, LLC
CompuGroup Medical AG
J&S Medical Associates, Inc.
Orchard Software Corporation
Schuyler House