Difference between revisions of "Laboratory information system"

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[[File:Nurse ict uganda.jpg|thumb|right|Hospitals and labs around the world depend on a laboratory information system to manage and report patient data and test results.]]
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[[File:Nurse ict uganda.jpg|thumb|250px|right|Hospitals and labs around the world depend on a laboratory information system to manage and report patient data and test results.]]
A '''laboratory information system''' (LIS) is a software system that records, manages, and stores data for clinical [[Laboratory|laboratories]]. A LIS has traditionally been most adept at sending laboratory test orders to lab instruments, tracking those orders, and then recording the results, typically to a searchable database.<ref name="biohealth">{{cite web_short|url=http://www.biohealthmatics.com/technologies/his/lis.aspx|title=Laboratory Information Systems|publisher=Biohealthmatics.com|date=10 August 2006|accessdate=06 May 2011}}</ref> The standard LIS has supported the operations of public health institutions (like hospitals and clinics) and their associated labs by managing and reporting critical data concerning "the status of infection, immunology, and care and treatment status of patients."<ref>{{cite web_short|url=http://www.aphl.org/aphlprograms/global/initiatives/Documents/LISQuickStartGuide.pdf|title=Quick Start Guide to Laboratory Information System (LIS) Implementation|format=PDF|publisher=Association of Public Health Laboratories|accessdate=06 May 2011}}</ref>
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A '''laboratory information system''' (LIS) is a software system that records, manages, and stores data for clinical [[Laboratory|laboratories]]. An LIS has traditionally been most adept at sending laboratory test orders to lab instruments, tracking those orders, and then recording the results, typically to a searchable database.<ref name="biohealth">{{cite web |url=http://www.biohealthmatics.com/technologies/his/lis.aspx |archiveurl=https://web.archive.org/web/20180106000403/http://www.biohealthmatics.com/technologies/his/lis.aspx |title=Laboratory Information Systems |work=Biohealthmatics.com |publisher=Biomedical Informatics Ltd |date=10 August 2006 |archivedate=06 January 2020 |accessdate=21 March 2020}}</ref> The standard LIS has supported the operations of public health institutions (like [[Hospital|hospitals]] and clinics) and their associated labs by managing and reporting critical data concerning "the status of infection, immunology, and care and treatment status of patients."<ref name="APHLLIS">{{cite web |url=https://www.aphl.org/MRC/Documents/GH_2005Oct_LIS-Quick-Start-Guide.pdf |archiveurl=https://web.archive.org/web/20170919184029/https://www.aphl.org/MRC/Documents/GH_2005Oct_LIS-Quick-Start-Guide.pdf |format=PDF |title=Quick Start Guide to Laboratory Information System (LIS) Implementation |publisher=Association of Public Health Laboratories |date=October 2005 |archivedate=19 September 2017 |accessdate=21 March 2020}}</ref>
  
==History of LIS==
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==History of the LIS==
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Advances in computational technology in the early 1960s led some to experiment with time and data management functions in the healthcare setting. Company Bolt Beranek Newman and the Massachusetts General Hospital worked together to create a system that "included time-sharing and multiuser techniques that would later be essential to the implementation of the modern LIS."<ref name="APLISReview">{{cite journal |journal=Advances in Anatomic Pathology |title=Anatomic Pathology Laboratory Information Systems: A Review |author=Park, S.L.; Pantanowitz, L.; Sharma, G.; Parwani, A.V. |volume=19 |issue=2 |page=81–96 |year=2012 |doi=10.1097/PAP.0b013e318248b787}}</ref> At around the same time General Electric announced plans to program a [[hospital information system]] (HIS), though those plans eventually fell through.<ref name="HistMedInfo">{{cite book |url=https://books.google.com/books/about/A_History_of_medical_informatics.html?id=AR5rAAAAMAAJ |title=A History of Medical Informatics |author=Blum, B.I.; Duncan, K.A. |publisher=ACM Press |year=1990 |pages=141–53 |isbn=9780201501287}}</ref>
  
Advances in computational technology in the early 1960s led some to experiment with time and data management functions in the healthcare setting. Company Bolt Beranek Newman and the Massachusetts General Hospital worked together to create a system that "included time-sharing and multiuser techniques that would later be essential to the implementation of the modern LIS."<ref name="APLISReview">{{cite journal |url=http://ebookbrowse.com/anatomic-pathology-laboratory-information-systems-a-review-slpark-et-all-adv-anat-pathol-2012-pdf-d344405134 |journal=Advances in Anatomic Pathology |year=March 2012 |volume=19 |issue=2 |page=81–96 |title=Anatomic Pathology Laboratory Information Systems: A Review |author=Park, Seung Lyung; Pantanowitz, Liron; Sharma, Guarav; Parwani, Anil Vasdev |doi=10.1097/PAP.0b013e318248b787 |accessdate=03 June 2013}}</ref> At around the same time General Electric announced plans to program a [[hospital information system]] (HIS), though those plans eventually fell through.<ref name="HistMedInfo">{{cite book |url=http://books.google.com/books/about/A_History_of_medical_informatics.html?id=AR5rAAAAMAAJ |title=A History of Medical Informatics |author=Blum, Bruce I.; Duncan, Karen A. |publisher=ACM Press |year=1990 |pages=141–53 |isbn=0201501287}}</ref>  
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Aside from the Massachusetts General Hospital experiment, the idea of a software system capable of managing time and data management functions wasn't heavily explored until the late 1960s, primarily because of the lack of proper technology and of communication between providers and end-users. The development of the Massachusetts General Hospital Utility Multi-Programming System (MUMPS) in the mid-'60s certainly helped as it suddenly allowed for a multi-user interface and a hierarchical system for persistent storage of data.<ref name="APLISReview" /> Yet due to its advanced nature, fragmented use across multiple entities, and inherent difficulty in extracting and analyzing data from the database, development of healthcare and laboratory systems on MUMPS was sporadic at best.<ref name="HistMedInfo" /> By the 1980s, however, the advent of Structured Query Language (SQL), relational database management systems (RDBMS), and [[Health Level 7]] (HL7) allowed software developers to expand the functionality and interoperability of the LIS, including the application of business analytics and business intelligence techniques to clinical data.<ref name="PractPathInfo">{{cite book |url=https://books.google.com/books?id=WerUyK618fcC |title=Practical Pathology Informatics: Demstifying Informatics for the Practicing Anatomic Pathologist |author=Sinard, J.H. |publisher=Springer |year=2006 |pages=393 |isbn=0387280588}}</ref>  
  
Aside from the Massachusetts General Hospital experiment, the idea of a software system capable of managing time and data management functions wasn't heavily explored until the late 1960s, primarily because of the lack of proper technology and of communication between providers and end-users. The development of the Massachusetts General Hospital Utility Multi-Programming System (MUMPS) in the mid-'60s certainly helped as it suddenly allowed for a multi-user interface and a hierarchical system for persistent storage of data.<ref name="APLISReview" /> Yet due to its advanced nature, fragmented use across multiple entities, and inherent difficulty in extracting and analyzing data from the database, development of healthcare and laboratory systems on MUMPS was sporadic at best.<ref name="HistMedInfo" /> By the 1980s, however, the advent of Structured Query Language (SQL), relational database management systems (RDBMS), and [[Health Level 7]] (HL7) allowed software developers to expand the functionality and interoperability of the LIS, including the application of business analytics and business intelligence techniques to clinical data.<ref name="PractPathInfo">{{cite book |url=http://books.google.com/books?id=WerUyK618fcC |title=Practical Pathology Informatics: Demstifying Informatics for the Practicing Anatomic Pathologist |author=Sinard, John H. |publisher=Springer |year=2006 |pages=393 |isbn=0387280588}}</ref>  
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In the early 2010s, web-based and database-centric internet applications of [[laboratory informatics]] software changed the way researchers and technicians interacted with data, with web-driven data formatting technologies like [[Extensible Markup Language]] (XML) making LIS and [[electronic medical record]] (EMR) interoperability a much-needed reality.<ref name="OverBarEMR">{{cite journal |title=Overcoming barriers to electronic medical record (EMR) implementation in the US healthcare system: A comparative study |journal=Health Informatics Journal |author=Kumar, S.; Aldrich, K. |volume=16 |issue=4 |year=2011 |doi=10.1177/1460458210380523}}</ref> [[Software as a service|SaaS]] and cloud computing technologies have since further changed how the LIS is implemented, while at the same time raising new questions about security and stability.<ref name="APLISReview" />  
  
Today, web-based and database-centric Internet applications of [[laboratory informatics]] software have changed the way researchers and technicians interact with data, with web-driven data formatting technologies like eXtensible Markup Language (XML) making LIS and [[electronic medical record|EMR]] interoperability a much-needed reality.<ref name="OverBarEMR">{{cite journal |url=http://jhi.sagepub.com/content/16/4/306.abstract |journal=Health Informatics Journal |year=December 2010 |volume=16 |issue=4 |title=Overcoming barriers to electronic medical record (EMR) implementation in the US healthcare system: A comparative study |author=Kumar, Sameer; Aldrich, Krista |doi=10.1177/1460458210380523 |accessdate=03 June 2013}}</ref> [[Software as a service|SaaS]] and cloud computing technologies have further changed how the LIS is implemented, while at the same time raising new questions about security and stability.<ref name="APLISReview" />
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The modern LIS has evolved to take on new functionalities not previously seen, including configurable [[Clinical decision support system|clinical decision support]] rules, system integration, laboratory outreach tools, and support for point-of-care testing (POCT) data. LIS modules have also begun to show up in EMR and [[electronic health record|EHR]] products, giving some laboratories the option to have an enterprise-wide solution that can cover multiple aspects of the lab.<ref name="FutrellWhatsNew17">{{cite web |url=https://www.mlo-online.com/continuing-education/article/13009013/whats-new-in-todays-lis |title=What's new in today's LIS? |author=Futrell, K. |work=Medical Laboratory Observer |publisher=NP Communications, LLC |date=23 January 2017 |accessdate=21 March 2020}}</ref> Additionally, the distinction between an LIS and a [[laboratory information management system]] (LIMS) has blurred somewhat, with some vendors choosing to use the "LIMS" acronym to market their clinical laboratory data management system.
  
 
==Common LIS functions==
 
==Common LIS functions==
 
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Functions that an LIS has historically performed include, but are not limited to<ref name="biohealth" /><ref name="FutrellWhatsNew17" /><ref name="MedLabInfoPaper">{{cite journal |title=Medical Laboratory Informatics |journal=Clinics in Laboratory Medicine |author=Pantanowitz, L.; Henricks, W.H.; Beckwith, B.A. |volume=27 |issue=4 |pages=823–43 |year=2007 |doi=10.1016/j.cll.2007.07.011}}</ref><ref name="MedLabInfoDesc">{{cite web |url=http://clinfowiki.org/wiki/index.php/Medical_laboratory_informatics |title=Medical laboratory informatics |work=ClinfoWiki |date=19 November 2011 |accessdate=03 June 2013}}</ref>:
Functions that a LIS has historically performed include, but are not limited to<ref name="biohealth" /><ref name="MedLabInfoPaper">{{cite journal |url=http://www.sciencedirect.com/science/article/pii/S0272271207000893 |journal=Clinics in Laboratory Medicine |year=December 2007 |volume=27 |issue=4 |pages=823–43 |title=Medical Laboratory Informatics |author=Pantanowitz, Liron; Henricks, Walter H.; Beckwith, Bruce A. |doi=10.1016/j.cll.2007.07.011 |accessdate=03 June 2013}}</ref><ref name="MedLabInfoDesc">{{cite web |url=http://clinfowiki.org/wiki/index.php/Medical_laboratory_informatics |title=Medical laboratory informatics |publisher=ClinfoWiki |date=19 November 2011 |accessdate=03 June 2013}}</ref>:
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* patient management, including admission date, admitting physician, ordering department, specimen type, etc.
 
* patient management, including admission date, admitting physician, ordering department, specimen type, etc.
 
* patient data tracking
 
* patient data tracking
 
* decision support, including comparisons of lab orders with their respective [[ICD-9]] codes
 
* decision support, including comparisons of lab orders with their respective [[ICD-9]] codes
* test ordering
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* standard test ordering and specimen tracking
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* test ordering for point-of-care, molecular, and genetic testing
 
* quality assurance
 
* quality assurance
 
* workload and management reporting
 
* workload and management reporting
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* analytical reporting
 
* workflow management
 
* workflow management
 
* billing
 
* billing
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* third-party software integration
  
 
===Clinical vs. anatomic pathology LIS===
 
===Clinical vs. anatomic pathology LIS===
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The laboratory information system has been primarily segmented into two broad categories (though other variations exist): the [[clinical pathology]] and [[anatomical pathology|anatomic pathology]] LIS.<ref name="MedLabInfoPaper" /><ref name="MedLabInfoDesc" /><ref name="CPAPLISDiffs">{{cite web |url=http://www.pathinformatics.pitt.edu/sites/default/files/2012Powerpoints/01HenricksTues.pdf |archiveurl=https://web.archive.org/web/20150910050825/http://www.pathinformatics.pitt.edu/sites/default/files/2012Powerpoints/01HenricksTues.pdf |format=PDF |title=LIS Basics: CP and AP LIS Design and Operations |work=Pathology Informatics 2012 |author=Henricks, W.H. |publisher=University of Pittsburgh |date=09 October 2012 |archivedate=10 September 2015 |accessdate=21 March 2020}}</ref>
  
The laboratory information system has been primarily segmented into two broad categories (though other variations exist): the [[anatomical pathology#Differences between anatomic pathology and clinical pathology|clinical pathology]] and [[anatomical pathology|anatomic pathology]] LIS.<ref name="MedLabInfoPaper" /><ref name="MedLabInfoDesc" /><ref name="CPAPLISDiffs">{{cite web |url=http://www.pathinformatics.pitt.edu/sites/default/files/2012Powerpoints/01HenricksTues.pdf |format=PDF |title=LIS Basics: CP and AP LIS Design and Operations |work=Pathology Informatics 2012 |author=Henricks, Walter H. |publisher=Walter H. Henricks, MD |date=09 October 2012 |accessdate=03 June 2013}}</ref>
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In clinical pathology the chemical, hormonal, and biochemical components of body fluids are analyzed and interpreted to determine if a disease is present, while anatomic pathology tends to focus on the analysis and interpretation of a wide variety of tissue structures, from small slivers via biopsy to complete organs from a surgery or autopsy.<ref name="ForensicMedBook">{{cite book |url=https://books.google.com/books?id=x5FftcZOv1UC&pg=PA3 |title=Forensic Medicine |author=Adelman, H.C. |pages=3–4 |publisher=Infobase Publishing |year=2009 |isbn=1438103816 |accessdate=03 June 2013}}</ref> These differences may appear to be small, but the differentiation in laboratory workflow of these two medical specialties has led to the creation of different functionalities within LISs. Specimen collection, receipt, and tracking; work distribution; and report generation may vary—sometimes significantly—between the two types of labs, requiring targeted functionality in the LIS.<ref name="CPAPLISDiffs" /><ref name="EvolvingLIS">{{cite web |url=https://www.mlo-online.com/home/article/13004085/the-evolving-lis-needs-to-be-everything-for-todays-laboratories |title=The evolving LIS needs to be "everything" for today's laboratories |author=Clifford, L.-J. |work=Medical Laboratory Observer |publisher=NP Communications, LLC |date=01 August 2011 |accessdate=21 March 2020}}</ref> Other differences include<ref name="APLISReview" />:
 
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In clinical pathology the chemical, hormonal, and biochemical components of body fluids are analyzed and interpreted to determine if a disease is present, while anatomic pathology tends to focus on the analysis and interpretation of a wide variety of tissue structures, from small slivers via biopsy to complete organs from a surgery or autopsy.<ref name="ForensicMedBook">{{cite book |url=http://books.google.com/books?id=x5FftcZOv1UC&pg=PA3 |title=Forensic Medicine |author=Adelman, Howard C. |pages=3–4 |publisher=Infobase Publishing |year=2009 |isbn=1438103816 |accessdate=03 June 2013}}</ref> These differences may appear to be small, but the differentiation in laboratory workflow of these two medical specialties has led to the creation of different functionalities within LISs. Specimen collection, receipt, and tracking; work distribution; and report generation may vary — sometimes significantly — between the two types of labs, requiring targeted functionality in the LIS.<ref name="CPAPLISDiffs" /><ref name="EvolvingLIS">{{cite web |url=http://www.mlo-online.com/articles/201108/the-evolving-lis-needs-to-be-everything-for-todays-laboratories.php |title=The evolving LIS needs to be "everything" for today's laboratories |author=Clifford, Lisa-Jean |publisher=Medical Laboratory Observer |date=August 2011 |accessdate=03 June 2013}}</ref> Other differences include<ref name="APLISReview" />:
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* Specific dictionary-driven tests are found in clinical pathology environments but not so much in anatomic pathology environments.
 
* Specific dictionary-driven tests are found in clinical pathology environments but not so much in anatomic pathology environments.
* Ordered anatomic pathology tests typically require more information than clinical pathology tests.
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* Ordered anatomic pathology tests typically require more [[information]] than clinical pathology tests.
 
* A single anatomic pathology order may be comprised of several tissues from several organs; clinical pathology orders usually do not.
 
* A single anatomic pathology order may be comprised of several tissues from several organs; clinical pathology orders usually do not.
 
* Anatomic pathology specimen collection may be a very procedural, multi-step processes, while clinical pathology specimen collection is routinely more simple.
 
* Anatomic pathology specimen collection may be a very procedural, multi-step processes, while clinical pathology specimen collection is routinely more simple.
  
== Differences between a LIS and LIMS ==
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== Differences between an LIS and a LIMS ==
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There is often confusion regarding the difference between an LIS and a LIMS. While the two laboratory informatics components are related, their purposes diverged early in their existences. Up until recently, the LIS and LIMS have exhibited a few key differences<ref name="StarlimsLimsLis">{{cite web |url=http://www.starlims.com/en-us/services-and-resources/resources/lis-vs-lims/ |archiveurl=https://web.archive.org/web/20140428060811/http://www.starlims.com/en-us/resources/white-papers/lis-vs-lims/ |title=Adding "Management" to Your LIS |publisher=STARLIMS Corporation |date=2012 |archivedate=28 April 2014 |accessdate=14 September 2017}}</ref>:
  
There is often confusion regarding the difference between a laboratory information system (LIS) and a [[laboratory information management system]] (LIMS). While the two laboratory informatics components are related, their purposes diverged early in their existences. Up until recently, LIMS and LIS have exhibited a few key differences:
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1. An LIS has been designed primarily for processing and reporting data related to individual patients in a clinical setting. A LIMS has traditionally been designed to process and report data related to batches of samples from drug trials, water treatment facilities, and other entities that handle complex batches of data.<ref name="lislims1">{{cite web |url=http://labsoftnews.typepad.com/lab_soft_news/2008/11/liss-vs-limss-its-time-to-consider-merging-the-two-types-of-systems.html |title=LIS vs. LIMS: It's Time to Blend the Two Types of Lab Information Systems |author=Friedman, B. |work=Lab Soft News |date=04 November 2008 |accessdate=07 November 2012}}</ref><ref name="analytica">{{cite web |url=http://www.analytica-world.com/en/news/35566/lims-lis-market-and-poct-supplement.html |title=LIMS/LIS Market and POCT Supplement |work=analytica-world.com |date=20 February 2004 |accessdate=07 November 2012}}</ref>
  
1. A LIS has been designed primarily for processing and reporting data related to individual patients in a clinical setting. A LIMS has traditionally been designed to process and report data related to batches of samples from drug trials, water treatment facilities, and other entities that handle complex batches of data.<ref name="lislims1">{{cite web|url=http://labsoftnews.typepad.com/lab_soft_news/2008/11/liss-vs-limss-its-time-to-consider-merging-the-two-types-of-systems.html|author=Friedman, Bruce| title=LIS vs. LIMS: It's Time to Blend the Two Types of Lab Information Systems|publisher=Lab Soft News|date=04 November 2008|accessdate=09 May 2011}}</ref><ref name="analytica">{{cite web_short|url=http://www.analytica-world.com/en/news/35566/lims-lis-market-and-poct-supplement.html|title=LIMS/LIS Market and POCT Supplement|publisher=analytica-world.com|date=20 February 2004|accessdate=09 May 2011}}</ref>
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2. An LIS must satisfy the reporting and auditing needs of hospital accreditation agencies, [[HIPAA]], and other clinical medical practitioners. A LIMS, however, needs to satisfy [[good manufacturing practice]] (GMP) and meet the reporting and audit needs of the U.S. [[Food and Drug Administration]] and research scientists in many different industries.<ref name="lislims1" />
  
2. A LIS must satisfy the reporting and auditing needs of hospital accreditation agencies, [[HIPAA]], and other clinical medical practitioners. A LIMS, however, needs to satisfy [[good manufacturing practice]] (GMP) and meet the reporting and audit needs of the U.S. [[Food and Drug Administration]] and research scientists in many different industries.<ref name="lislims1" />
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3. An LIS is usually most competitive in patient-centric settings (dealing with "subjects" and "specimens") and clinical labs, whereas a LIMS is most competitive in group-centric settings (dealing with "batches" and "samples") that often deal with mostly anonymous research-specific laboratory data.<ref name="analytica" /><ref name="lislims2">{{cite web |url=http://labsoftnews.typepad.com/lab_soft_news/2008/11/lis-vs-lims.html |title=LIS vs. LIMS: Some New Insights |author=Friedman, B. |work=Lab Soft News |date=19 November 2008 |accessdate=07 November 2012}}</ref><ref name="starlims">{{cite web |url=http://blog.starlims.com/2009/07/01/swimming-in-the-clinical-pool-why-lims-are-supplanting-old-school-clinical-lis-applications/ |archiveurl=https://web.archive.org/web/20110313145726/http://blog.starlims.com/2009/07/01/swimming-in-the-clinical-pool-why-lims-are-supplanting-old-school-clinical-lis-applications/ |title=Swimming in the Clinical Pool: Why LIMS are supplanting old-school clinical LIS applications |author=Hice, R. |publisher=STARLIMS Corporation |date=01 July 2009 |archivedate=13 March 2011 |accessdate=14 September 2017}}</ref>
  
3. A LIS is usually most competitive in patient-centric settings (dealing with "subjects" and "specimens") and clinical labs, whereas a LIMS is most competitive in group-centric settings (dealing with "batches" and "samples") that often deal with mostly anonymous research-specific laboratory data.<ref name="analytica" /><ref name="lislims2">{{cite web|url=http://labsoftnews.typepad.com/lab_soft_news/2008/11/lis-vs-lims.html|author=Friedman, Bruce |title=LIS vs. LIMS: Some New Insights|publisher=Lab Soft News|date=19 November 2008|accessdate=09 May 2011}}</ref><ref name="starlims">{{cite web|url=http://blog.starlims.com/2009/07/01/swimming-in-the-clinical-pool-why-lims-are-supplanting-old-school-clinical-lis-applications/|title=Swimming in the Clinical Pool: Why LIMS are supplanting old-school clinical LIS applications|author=Hice, Randy |publisher=STARLIMS' Laboratory Informatics Blog|date=01 July 2009|accessdate=09 May 2011}}</ref>
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However, these distinctions began to fade somewhat in the early 2010s as some LIMS vendors began to adopt the case-centric information management normally reserved for an LIS, blurring the lines between the two components further.<ref name="starlims" /> [[Thermo Scientific]]'s Clinical LIMS was an example of this merger of the LIS with LIMS, with Dave Champagne, informatics vice president and general manager, stating: "Routine molecular diagnostics requires a convergence of the up-to-now separate systems that have managed work in the lab (the LIMS) and the clinic (the LIS). The industry is asking for, and the science is requiring, a single lab-centric solution that delivers patient-centric results."<ref name="ConvergeLimsLis">{{cite web |url=http://www.clpmag.com/2012/02/convergence-of-lims-and-lis/ |title=Convergence of LIMS and LIS |author=Tufel, G. |work=Clinical Lab Products |publisher=MEDQOR |date=01 February 2012 |accessdate=14 September 2017}}</ref> [[Abbott Informatics Corporation]]'s STARLIMS product was another example of this LIS/LIMS merger.<ref name="StarlimsLimsLis" /> With the distinction between the two entities becoming less clear, discussions within the laboratory informatics community began to includes the question of whether or not the two entities should be considered the same.<ref name="LinkedInDifLisLims">{{cite web |url=https://www.linkedin.com/feed/update/urn:li:groupPost:2069898-98494737/ |title=What is the difference between an LIS and a LIMS? |author=Jones, J. |publisher=LinkedIn |date=March 2012 |accessdate=21 March 2020}}</ref><ref name="LinkedInLisLimsSame">{{cite web |url=http://www.linkedin.com/groups/Are-LIMS-LIS-same-thing-2069898.S.147132083 |title=Are LIMS and LIS the same thing? |author=Jones, John |publisher=LinkedIn |date=September 2012 |accessdate=07 November 2012}}</ref> {{As of|2017}}, vendors continue to recognize the historical differences between the two products while also continuing to acknowledge that some developed LIMS are taking on more of the clinical aspects usually reserved for an LIS.<ref name="AgilabFAQ">{{cite web |url=http://agilab.com/faq/ |archiveurl=https://web.archive.org/web/20190325075813/http://agilab.com/faq/ |title=FAQ: What is the difference between a LIMS and a medical laboratory quality system? |publisher=AgiLab SAS |archivedate=25 March 2019 |accessdate=21 March 2020}}</ref><ref name="CloudLISDifference16">{{cite web |url=https://cloudlims.com/lims/lims-vs-lis.html |title=Difference Between LIS and LIMS |publisher=CloudLIMS.com, LLC |date=01 October 2016 |accessdate=14 September 2017}}</ref><ref name="ReisenwitzWhatIs17">{{cite web |url=http://blog.capterra.com/what-is-a-laboratory-information-management-system/ |title=What Is a Laboratory Information Management System? |author=Reisenwitz, C. |work=Capterra Medical Software Blog |publisher=Capterra, Inc |date=11 May 2017 |accessdate=14 September 2017}}</ref>
 
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However, as of 2011 these distinctions have faded somewhat as some LIMS vendors have adopted the case-centric information management normally reserved for a LIS, blurring the lines between the two components further.<ref name="starlims" /><ref name="HowDoIFindLII">{{cite web |url=http://files.limstitute.com/share/lbgprofiles/findlims.pdf |format=PDF |title=How Do I Find the Right LIMS — And How Much Will It Cost? |publisher=Laboratory Informatics Institute, Inc |accessdate=07 November 2012}}</ref>
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==LIS vendors==
 
==LIS vendors==
 
 
See the [[LIS vendor]] page for a list of LIS vendors past and present.
 
See the [[LIS vendor]] page for a list of LIS vendors past and present.
  
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== Further reading ==
 
== Further reading ==
  
* {{cite web |url=http://www.pathinformatics.pitt.edu/sites/default/files/2012Powerpoints/01HenricksTues.pdf |format=PDF |title=LIS Basics: CP and AP LIS Design and Operations |work=Pathology Informatics 2012 |author=Henricks, Walter H. |publisher=Walter H. Henricks, MD |date=09 October 2012}}
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* {{cite web |url=http://www.pathinformatics.pitt.edu/sites/default/files/2012Powerpoints/01HenricksTues.pdf |archiveurl=https://web.archive.org/web/20150910050825/http://www.pathinformatics.pitt.edu/sites/default/files/2012Powerpoints/01HenricksTues.pdf |format=PDF |title=LIS Basics: CP and AP LIS Design and Operations |work=Pathology Informatics 2012 |author=Henricks, W.H. |publisher=University of Pittsburgh |date=09 October 2012 |archivedate=10 September 2015}}
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* {{cite journal |journal=Advances in Anatomic Pathology |title=Anatomic Pathology Laboratory Information Systems: A Review |author=Park, S.L.; Pantanowitz, L.; Sharma, G.; Parwani, A.V. |volume=19 |issue=2 |page=81–96 |year=2012 |doi=10.1097/PAP.0b013e318248b787}}
  
* {{cite journal |url=http://ebookbrowse.com/anatomic-pathology-laboratory-information-systems-a-review-slpark-et-all-adv-anat-pathol-2012-pdf-d344405134 |journal=Advances in Anatomic Pathology |year=March 2012 |volume=19 |issue=2 |page=81–96 |title=Anatomic Pathology Laboratory Information Systems: A Review |author=Park, Seung Lyung; Pantanowitz, Liron; Sharma, Guarav; Parwani, Anil Vasdev |doi=10.1097/PAP.0b013e318248b787}} ([https://docs.google.com/gview?url=http://bpa-pathology.com/uploads/file/docs/Anatomic+Pathology+Laboratory+Information+Systems+-+A+Review+-+SLPark+et+all.+-+Adv+Anat+Pathol+2012.pdf&chrome=true Alternate URL])
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==References==
== References ==
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{{Reflist|colwidth=30em}}
<references />
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[[Category:Laboratory informatics]]
 
[[Category:Laboratory informatics]]
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[[Category:Software systems]]

Latest revision as of 21:54, 21 March 2020

Hospitals and labs around the world depend on a laboratory information system to manage and report patient data and test results.

A laboratory information system (LIS) is a software system that records, manages, and stores data for clinical laboratories. An LIS has traditionally been most adept at sending laboratory test orders to lab instruments, tracking those orders, and then recording the results, typically to a searchable database.[1] The standard LIS has supported the operations of public health institutions (like hospitals and clinics) and their associated labs by managing and reporting critical data concerning "the status of infection, immunology, and care and treatment status of patients."[2]

History of the LIS

Advances in computational technology in the early 1960s led some to experiment with time and data management functions in the healthcare setting. Company Bolt Beranek Newman and the Massachusetts General Hospital worked together to create a system that "included time-sharing and multiuser techniques that would later be essential to the implementation of the modern LIS."[3] At around the same time General Electric announced plans to program a hospital information system (HIS), though those plans eventually fell through.[4]

Aside from the Massachusetts General Hospital experiment, the idea of a software system capable of managing time and data management functions wasn't heavily explored until the late 1960s, primarily because of the lack of proper technology and of communication between providers and end-users. The development of the Massachusetts General Hospital Utility Multi-Programming System (MUMPS) in the mid-'60s certainly helped as it suddenly allowed for a multi-user interface and a hierarchical system for persistent storage of data.[3] Yet due to its advanced nature, fragmented use across multiple entities, and inherent difficulty in extracting and analyzing data from the database, development of healthcare and laboratory systems on MUMPS was sporadic at best.[4] By the 1980s, however, the advent of Structured Query Language (SQL), relational database management systems (RDBMS), and Health Level 7 (HL7) allowed software developers to expand the functionality and interoperability of the LIS, including the application of business analytics and business intelligence techniques to clinical data.[5]

In the early 2010s, web-based and database-centric internet applications of laboratory informatics software changed the way researchers and technicians interacted with data, with web-driven data formatting technologies like Extensible Markup Language (XML) making LIS and electronic medical record (EMR) interoperability a much-needed reality.[6] SaaS and cloud computing technologies have since further changed how the LIS is implemented, while at the same time raising new questions about security and stability.[3]

The modern LIS has evolved to take on new functionalities not previously seen, including configurable clinical decision support rules, system integration, laboratory outreach tools, and support for point-of-care testing (POCT) data. LIS modules have also begun to show up in EMR and EHR products, giving some laboratories the option to have an enterprise-wide solution that can cover multiple aspects of the lab.[7] Additionally, the distinction between an LIS and a laboratory information management system (LIMS) has blurred somewhat, with some vendors choosing to use the "LIMS" acronym to market their clinical laboratory data management system.

Common LIS functions

Functions that an LIS has historically performed include, but are not limited to[1][7][8][9]:

  • patient management, including admission date, admitting physician, ordering department, specimen type, etc.
  • patient data tracking
  • decision support, including comparisons of lab orders with their respective ICD-9 codes
  • standard test ordering and specimen tracking
  • test ordering for point-of-care, molecular, and genetic testing
  • quality assurance
  • workload and management reporting
  • analytical reporting
  • workflow management
  • billing
  • third-party software integration

Clinical vs. anatomic pathology LIS

The laboratory information system has been primarily segmented into two broad categories (though other variations exist): the clinical pathology and anatomic pathology LIS.[8][9][10]

In clinical pathology the chemical, hormonal, and biochemical components of body fluids are analyzed and interpreted to determine if a disease is present, while anatomic pathology tends to focus on the analysis and interpretation of a wide variety of tissue structures, from small slivers via biopsy to complete organs from a surgery or autopsy.[11] These differences may appear to be small, but the differentiation in laboratory workflow of these two medical specialties has led to the creation of different functionalities within LISs. Specimen collection, receipt, and tracking; work distribution; and report generation may vary—sometimes significantly—between the two types of labs, requiring targeted functionality in the LIS.[10][12] Other differences include[3]:

  • Specific dictionary-driven tests are found in clinical pathology environments but not so much in anatomic pathology environments.
  • Ordered anatomic pathology tests typically require more information than clinical pathology tests.
  • A single anatomic pathology order may be comprised of several tissues from several organs; clinical pathology orders usually do not.
  • Anatomic pathology specimen collection may be a very procedural, multi-step processes, while clinical pathology specimen collection is routinely more simple.

Differences between an LIS and a LIMS

There is often confusion regarding the difference between an LIS and a LIMS. While the two laboratory informatics components are related, their purposes diverged early in their existences. Up until recently, the LIS and LIMS have exhibited a few key differences[13]:

1. An LIS has been designed primarily for processing and reporting data related to individual patients in a clinical setting. A LIMS has traditionally been designed to process and report data related to batches of samples from drug trials, water treatment facilities, and other entities that handle complex batches of data.[14][15]

2. An LIS must satisfy the reporting and auditing needs of hospital accreditation agencies, HIPAA, and other clinical medical practitioners. A LIMS, however, needs to satisfy good manufacturing practice (GMP) and meet the reporting and audit needs of the U.S. Food and Drug Administration and research scientists in many different industries.[14]

3. An LIS is usually most competitive in patient-centric settings (dealing with "subjects" and "specimens") and clinical labs, whereas a LIMS is most competitive in group-centric settings (dealing with "batches" and "samples") that often deal with mostly anonymous research-specific laboratory data.[15][16][17]

However, these distinctions began to fade somewhat in the early 2010s as some LIMS vendors began to adopt the case-centric information management normally reserved for an LIS, blurring the lines between the two components further.[17] Thermo Scientific's Clinical LIMS was an example of this merger of the LIS with LIMS, with Dave Champagne, informatics vice president and general manager, stating: "Routine molecular diagnostics requires a convergence of the up-to-now separate systems that have managed work in the lab (the LIMS) and the clinic (the LIS). The industry is asking for, and the science is requiring, a single lab-centric solution that delivers patient-centric results."[18] Abbott Informatics Corporation's STARLIMS product was another example of this LIS/LIMS merger.[13] With the distinction between the two entities becoming less clear, discussions within the laboratory informatics community began to includes the question of whether or not the two entities should be considered the same.[19][20] As of 2017, vendors continue to recognize the historical differences between the two products while also continuing to acknowledge that some developed LIMS are taking on more of the clinical aspects usually reserved for an LIS.[21][22][23]

LIS vendors

See the LIS vendor page for a list of LIS vendors past and present.

See also

Further reading

  • Park, S.L.; Pantanowitz, L.; Sharma, G.; Parwani, A.V. (2012). "Anatomic Pathology Laboratory Information Systems: A Review". Advances in Anatomic Pathology 19 (2): 81–96. doi:10.1097/PAP.0b013e318248b787. 

References

  1. 1.0 1.1 "Laboratory Information Systems". Biohealthmatics.com. Biomedical Informatics Ltd. 10 August 2006. Archived from the original on 06 January 2020. https://web.archive.org/web/20180106000403/http://www.biohealthmatics.com/technologies/his/lis.aspx. Retrieved 21 March 2020. 
  2. "Quick Start Guide to Laboratory Information System (LIS) Implementation" (PDF). Association of Public Health Laboratories. October 2005. Archived from the original on 19 September 2017. https://web.archive.org/web/20170919184029/https://www.aphl.org/MRC/Documents/GH_2005Oct_LIS-Quick-Start-Guide.pdf. Retrieved 21 March 2020. 
  3. 3.0 3.1 3.2 3.3 Park, S.L.; Pantanowitz, L.; Sharma, G.; Parwani, A.V. (2012). "Anatomic Pathology Laboratory Information Systems: A Review". Advances in Anatomic Pathology 19 (2): 81–96. doi:10.1097/PAP.0b013e318248b787. 
  4. 4.0 4.1 Blum, B.I.; Duncan, K.A. (1990). A History of Medical Informatics. ACM Press. pp. 141–53. ISBN 9780201501287. https://books.google.com/books/about/A_History_of_medical_informatics.html?id=AR5rAAAAMAAJ. 
  5. Sinard, J.H. (2006). Practical Pathology Informatics: Demstifying Informatics for the Practicing Anatomic Pathologist. Springer. pp. 393. ISBN 0387280588. https://books.google.com/books?id=WerUyK618fcC. 
  6. Kumar, S.; Aldrich, K. (2011). "Overcoming barriers to electronic medical record (EMR) implementation in the US healthcare system: A comparative study". Health Informatics Journal 16 (4). doi:10.1177/1460458210380523. 
  7. 7.0 7.1 Futrell, K. (23 January 2017). "What's new in today's LIS?". Medical Laboratory Observer. NP Communications, LLC. https://www.mlo-online.com/continuing-education/article/13009013/whats-new-in-todays-lis. Retrieved 21 March 2020. 
  8. 8.0 8.1 Pantanowitz, L.; Henricks, W.H.; Beckwith, B.A. (2007). "Medical Laboratory Informatics". Clinics in Laboratory Medicine 27 (4): 823–43. doi:10.1016/j.cll.2007.07.011. 
  9. 9.0 9.1 "Medical laboratory informatics". ClinfoWiki. 19 November 2011. http://clinfowiki.org/wiki/index.php/Medical_laboratory_informatics. Retrieved 03 June 2013. 
  10. 10.0 10.1 Henricks, W.H. (09 October 2012). "LIS Basics: CP and AP LIS Design and Operations" (PDF). Pathology Informatics 2012. University of Pittsburgh. Archived from the original on 10 September 2015. https://web.archive.org/web/20150910050825/http://www.pathinformatics.pitt.edu/sites/default/files/2012Powerpoints/01HenricksTues.pdf. Retrieved 21 March 2020. 
  11. Adelman, H.C. (2009). Forensic Medicine. Infobase Publishing. pp. 3–4. ISBN 1438103816. https://books.google.com/books?id=x5FftcZOv1UC&pg=PA3. Retrieved 03 June 2013. 
  12. Clifford, L.-J. (01 August 2011). "The evolving LIS needs to be "everything" for today's laboratories". Medical Laboratory Observer. NP Communications, LLC. https://www.mlo-online.com/home/article/13004085/the-evolving-lis-needs-to-be-everything-for-todays-laboratories. Retrieved 21 March 2020. 
  13. 13.0 13.1 "Adding "Management" to Your LIS". STARLIMS Corporation. 2012. Archived from the original on 28 April 2014. https://web.archive.org/web/20140428060811/http://www.starlims.com/en-us/resources/white-papers/lis-vs-lims/. Retrieved 14 September 2017. 
  14. 14.0 14.1 Friedman, B. (04 November 2008). "LIS vs. LIMS: It's Time to Blend the Two Types of Lab Information Systems". Lab Soft News. http://labsoftnews.typepad.com/lab_soft_news/2008/11/liss-vs-limss-its-time-to-consider-merging-the-two-types-of-systems.html. Retrieved 07 November 2012. 
  15. 15.0 15.1 "LIMS/LIS Market and POCT Supplement". analytica-world.com. 20 February 2004. http://www.analytica-world.com/en/news/35566/lims-lis-market-and-poct-supplement.html. Retrieved 07 November 2012. 
  16. Friedman, B. (19 November 2008). "LIS vs. LIMS: Some New Insights". Lab Soft News. http://labsoftnews.typepad.com/lab_soft_news/2008/11/lis-vs-lims.html. Retrieved 07 November 2012. 
  17. 17.0 17.1 Hice, R. (01 July 2009). "Swimming in the Clinical Pool: Why LIMS are supplanting old-school clinical LIS applications". STARLIMS Corporation. Archived from the original on 13 March 2011. https://web.archive.org/web/20110313145726/http://blog.starlims.com/2009/07/01/swimming-in-the-clinical-pool-why-lims-are-supplanting-old-school-clinical-lis-applications/. Retrieved 14 September 2017. 
  18. Tufel, G. (01 February 2012). "Convergence of LIMS and LIS". Clinical Lab Products. MEDQOR. http://www.clpmag.com/2012/02/convergence-of-lims-and-lis/. Retrieved 14 September 2017. 
  19. Jones, J. (March 2012). "What is the difference between an LIS and a LIMS?". LinkedIn. https://www.linkedin.com/feed/update/urn:li:groupPost:2069898-98494737/. Retrieved 21 March 2020. 
  20. Jones, John (September 2012). "Are LIMS and LIS the same thing?". LinkedIn. http://www.linkedin.com/groups/Are-LIMS-LIS-same-thing-2069898.S.147132083. Retrieved 07 November 2012. 
  21. "FAQ: What is the difference between a LIMS and a medical laboratory quality system?". AgiLab SAS. Archived from the original on 25 March 2019. https://web.archive.org/web/20190325075813/http://agilab.com/faq/. Retrieved 21 March 2020. 
  22. "Difference Between LIS and LIMS". CloudLIMS.com, LLC. 01 October 2016. https://cloudlims.com/lims/lims-vs-lis.html. Retrieved 14 September 2017. 
  23. Reisenwitz, C. (11 May 2017). "What Is a Laboratory Information Management System?". Capterra Medical Software Blog. Capterra, Inc. http://blog.capterra.com/what-is-a-laboratory-information-management-system/. Retrieved 14 September 2017.