Difference between revisions of "User:Shawndouglas/sandbox/sublevel12"

From LIMSWiki
Jump to navigationJump to search
Line 8: Line 8:
==Sandbox begins below==
==Sandbox begins below==
<div class="nonumtoc">__TOC__</div>
<div class="nonumtoc">__TOC__</div>
[[File:Icos Laboratories.JPG|thumb|360px|right|Laboratories around the world depend on a LIMS to manage data, assign rights, manage inventory, and more.]]
[[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.]]
Sometimes referred to as a [[laboratory information system]] (LIS) or laboratory management system (LMS), a '''laboratory information management system''' (LIMS) is a software-based [[laboratory]] and [[information management]] system that offers a set of key features that support a modern laboratory's operations. Those key features include—but are not limited to—[[Workflow|workflow]] and data tracking support, flexible architecture, and smart data exchange interfaces, which fully "support its use in regulated environments."<ref name="SapioWhatIs10">{{cite web |url=http://sapiosciences.blogspot.com/2010/07/so-what-is-lims.html |archiveurl=https://web.archive.org/web/20160304102056/http://sapiosciences.blogspot.com/2010/07/so-what-is-lims.html |title=So what is a LIMS? |work=Laboratory Information Management |publisher=Sapio Sciences |date=28 July 2010 |archivedate=04 March 2016 |accessdate=12 March 2024}}</ref> The features and uses of a LIMS have evolved over the years from simple [[sample]] tracking to an integrated application that handles laboratory management, [[Quality (business)|quality]] management, and enterprise resource planning processes, from testing and [[quality control]] to reporting and invoicing.
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>


Due to the rapid pace at which laboratories and their data management needs shift, the definition of LIMS has become somewhat controversial. As the needs of the modern laboratory vary widely from lab to lab, what is needed from a LIMS also shifts. The end result: the definition of a LIMS will shift based on who you ask and what their vision of the modern lab is.<ref name="SapioWhatIs10" /> Dr. Alan McLelland of the Institute of Biochemistry, Royal Infirmary, Glasgow highlighted this problem in the late 1990s by explaining how a LIMS is perceived by an analyst, a laboratory manager, an information systems manager, and an accountant, "all of them correct, but each of them limited by the users' own perceptions."<ref name="McLelland98">{{cite web |url=http://www.rsc.org/pdf/andiv/tech.pdf |archiveurl=https://web.archive.org/web/20131004232754/http://www.rsc.org/pdf/andiv/tech.pdf |format=PDF |title=What is a LIMS - a laboratory toy, or a critical IT component? |author=McLelland, A. |publisher=Royal Society of Chemistry |page=1 |date=1998 |archivedate=04 October 2013 |accessdate=12 March 2024}}</ref>
==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."<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>  


Historically the term "LIMS" has tended to be used to reference [[laboratory informatics]] systems targeted for environmental, research, or industrial analysis such as water quality, pharmaceutical, or petrochemical work. "LIS" has tended to be used to reference informatics systems in the [[Forensic science|forensics]] and clinical markets, which often requires special case and patient management tools. In modern times, LIMS functionality has spread even farther beyond its original purpose of sample management. [[Assay]] data management, data mining, statistical analysis, [[Electronic laboratory notebook|electronic laboratory notebook]] (ELN) integration, and industry-specific functionality that supports regulatory requirements in that industry (e.g., [[hazard analysis and critical control points]] [HACCP] workflow tools in food and beverage manufacturing) are all types of functionality added to LIMS, enabling the realization of greater laboratory and enterprise management through one software solution. Additionally, the distinction between a LIMS and a LIS has blurred, as many LIMS now also fully support comprehensive case-centric clinical specimen and patient data management.
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>


==History==
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" />  
Up until the late 1970s, management of laboratory samples and their associated analysis and reporting was a time-consuming manual processes often riddled with transcription errors. This gave some organizations impetus to streamline the collection of data and how it was reported. Custom in-house solutions were developed by a few individual laboratories, while some enterprising entities at the same time sought to develop a more commercial reporting solution in the form of special instrument-based systems.<ref name="LIMSHistory">{{cite journal |title=A brief history of LIMS |journal=Laboratory Automation and Information Management |author=Gibbon, G.A. |volume=32 |issue=1 |pages=1–5 |year=1996 |doi=10.1016/1381-141X(95)00024-K}}</ref>  


In 1982, the first generation of LIMS was introduced in the form of a single centralized minicomputer, which offered laboratories the first opportunity to utilize automated reporting tools. As the interest in these early LIMS grew, industry leaders like Gerst Gibbon of the Federal Energy Technology Centre in Pittsburgh began planting the seeds through LIMS-related conferences. By 1988, the second-generation commercial offerings were tapping into [[Relational database|relational databases]] to expand LIMS into more application-specific territory, and international LIMS conferences were in full swing. As personal computers became more powerful and prominent, a third generation of LIMS emerged in the early 1990s. These new LIMS took advantage of the developing client/server architecture, allowing laboratories to implement better data processing and exchanges.<ref name="LIMSHistory" />
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.  


By 1995, the client/server tools had developed to the point of allowing processing of data anywhere on the network. Web-enabled LIMS were introduced the following year, enabling researchers to extend operations outside the confines of the laboratory. From 1996 to 2002, additional functionality was included in LIMS, from wireless networking capabilities and georeferencing of samples, to the adoption of [[XML]] standards and the development of internet-based purchasing.<ref name="LIMSHistory" />
==Common LIS functions==
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>:


By the early 2010s, some LIMS had added additional characteristics that continued to shape how a LIMS was defined. Examples include the addition of clinical functionality and [[electronic laboratory notebook]] (ELN) functionality, as well a rise in the cloud-based [[software as a service]] (SaaS) distribution model.<ref name="LinkedInSaaSModel">{{cite web |url=https://www.linkedin.com/feed/update/urn:li:groupPost:2069898-181604484/ |title=Is any one aware of a SaaS LIMS success story? |author=Nagisetty, P. |publisher=LinkedIn |date=02 November 2012 |accessdate=12 March 2024}}</ref><ref name="MullinLIMS10">{{cite journal |title=LIMS in the Cloud |journal=Chemical & Engineering News |author=Mullin, R. |volume=88 |issue=21 |pages=12–16 |date=24 May 2010 |url=http://cen.acs.org/articles/88/i21/LIMS-Cloud.html |accessdate=12 March 2024}}</ref> By the late 2010s, cloud-based LIMS were more numerous in quantity and adoption but not the ''de facto'' standard, as the costs and daunting nature associated with vendors transitioning legacy products to the cloud and with companies trying to integrate a cloud-based LIMS into a complicated IT and regulatory environment had partially stymied growth.<ref name="KnippenbergMoving17">{{cite web |url=https://astrixinc.com/moving-lab-infrastructure-cloud-consider-nearshoring/ |archiveurl=https://web.archive.org/web/20230131012812/https://astrixinc.com/moving-lab-infrastructure-cloud-consider-nearshoring/ |title=Moving your Lab IT Infrastructure to the Cloud? Consider Nearshoring |author=Knippenberg, R. |work=Astrix Blog |publisher=Astrix Technology Group |date=09 May 2017 |archivedate=31 January 2023 |accessdate=12 March 2024}}</ref><ref name="JoyceWhatYou17">{{cite web |url=https://www.labmanager.com/what-you-and-your-it-team-should-know-about-the-cloud-3048 |title=What You and Your IT Team Should Know About the Cloud |work=Lab Manager |author=Joyce, J. |publisher=LabX Media Group |date=01 May 2017 |accessdate=12 March 2024}}</ref> Today, despite these challenges, cloud-based approaches to the management of laboratory data continue to see adoption or intent to adopt<ref name="AstrixProgress22">{{cite web |url=https://astrixinc.com/wp-content/uploads/2022/06/Progress-Snapshot-on-Enabling-the-Digital-Lab-of-the-Future-v4a.pdf |format=PDF |title=2022 Laboratory Informatics: Progress Snapshot on Enabling the Digital Lab of the Future |publisher=Astrix Technology, LLC |pages=18–23 |date=June 2022 |accessdate=12 March 2024}}</ref><ref name="Lanewala2024LIMS24">{{cite web |url=https://clarkstonconsulting.com/insights/2024-lims-trends/ |title=2024 LIMS Trends |author=Lanewala, M.; Yauger, T.; Jones, L.L. |work=Clarkston Consulting Insights |publisher=Clarkston Consulting |date=04 March 2024 |accessdate=12 March 2024}}</ref>, including in the more heavily regulated GxP (good practice) laboratories, which have their own unique challenges with [[data integrity]] and [[Information security|security]] requirements.<ref>{{Cite journal |last=Davis |first=Scott |last2=Usansky |first2=Joel |last3=Mitra-Kaushik |first3=Shibani |last4=Kellie |first4=John |last5=Honrine |first5=Kimberly |last6=Woolf |first6=Eric |last7=Adams |first7=Jeb |last8=Kelly |first8=Ryan |last9=Evens |first9=John |last10=Pine |first10=Samuel |last11=Hochreiner |first11=Hannes |date=2021-09 |title=Cloud solutions for GxP laboratories: considerations for data storage |url=https://www.future-science.com/doi/10.4155/bio-2021-0137 |journal=Bioanalysis |language=en |volume=13 |issue=17 |pages=1313–1321 |doi=10.4155/bio-2021-0137 |issn=1757-6180}}</ref>
* 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


==Purpose and technology==
===Clinical vs. anatomic pathology LIS===
A LIMS is a software solution designed to allow end users to better manage a wide variety of operational and quality management aspects of academic, government, and industrial laboratories serving a broad range of industries and stakeholders. The software can be monolithic or microservices-based, with each architecture type having its own pros and cons, especially dependent upon the number of concurrent users, desired functional scale, and deployment method (e.g., on-premises vs. [[Cloud computing|in the cloud]]).<ref>{{Cite journal |last=Blinowski |first=Grzegorz |last2=Ojdowska |first2=Anna |last3=Przybylek |first3=Adam |date=2022 |title=Monolithic vs. Microservice Architecture: A Performance and Scalability Evaluation |url=https://ieeexplore.ieee.org/document/9717259/ |journal=IEEE Access |volume=10 |pages=20357–20374 |doi=10.1109/ACCESS.2022.3152803 |issn=2169-3536}}</ref> The reasons for adopting a LIMS and other [[laboratory informatics]] solutions varies by laboratory, but common purposes for adopting such systems include wanting to automate and better manage laboratory processes; more accurately capture laboratory and experiment data; more efficiently calculate, prepare, and disseminate analytical results; better aggregate and analyze laboratory data and information; increase throughput and productivity; and enhance regulatory compliance.<ref name="AstrixProgress22" /> Through regulatory, market, customer, and technological pressures, many laboratories have decided that increasingly digitizing the laboratory makes sense in its efforts towards compliance, competitiveness, relevancy, and efficiency.<ref name="AstrixProgress22" /><ref name="LiscouskiJust23">{{cite book |url=https://www.limswiki.org/index.php/LII:Justifying_LIMS_Acquisition_and_Deployment_within_Your_Organization/Introduction_to_LIMS_and_its_acquisition_and_deployment |title=Justifying LIMS Acquisition and Deployment within Your Organization |chapter=1. Introduction to LIMS and its acquisition and deployment |author=Liscouski, J. |editor=Douglas, S.E. |publisher=LIMSwiki |date=July 2023 |accessdate=13 March 2024}}</ref> A LIMS deployment primarily focuses on sample management, data acquisition, and reporting activities; however, its scope can expand much further depending on the scientific discipline or industry served. The following subsections examine these concepts further.
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>


===Laboratory information management operations===
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" />:
The LIMS is an evolving concept, with new features and functionality being added often. As laboratory demands change and technological progress continues, the functions of a LIMS will likely also change. Despite these changes, a LIMS tends to have a base set of functionality that defines it. That functionality can roughly be divided into five laboratory processing phases, with numerous software functions falling under each<ref name="MT5310">{{cite journal |title=Laboratory information management systems in the work of the analytic laboratory |journal=Measurement Techniques |author=Skobelev, D.O.; Zaytseva, T.M.; Kozlov, A.D. et al. |volume=53 |issue=10 |pages=1182–1189 |year=2011 |doi=10.1007/s11018-011-9638-7}}</ref>:  


*the reception and log in of a sample and its associated customer data;
* Specific dictionary-driven tests are found in clinical pathology environments but not so much in anatomic pathology environments.
*the assignment, scheduling, and tracking of the sample and the associated analytical workload;
* Ordered anatomic pathology tests typically require more [[information]] than clinical pathology tests.
*the processing and quality control associated with the sample and the utilized equipment and inventory;
* A single anatomic pathology order may be comprised of several tissues from several organs; clinical pathology orders usually do not.
*the storage of data associated with the sample analysis; and
* Anatomic pathology specimen collection may be a very procedural, multi-step processes, while clinical pathology specimen collection is routinely more simple.
*the inspection, approval, and compilation of the sample data for reporting and/or further analysis.


There are several pieces of core functionality associated with these laboratory processing phases that tend to appear in most LIMS.
== 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<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>:


====Sample management====
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=https://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=06 January 2022}}</ref>
[[File:Lab worker with blood samples.jpg|thumb|260px|right|A lab worker matches blood samples to documents. With a LIMS, this sort of sample management is made more efficient.]]
The core function of LIMS has traditionally been and largely continues to be the management of samples.<ref name="LIMSHistory" /><ref name="KranjcIntro21">{{Citation |last=Kranjc |first=Tilen |date=2021-08-16 |editor-last=Zupancic |editor-first=Klemen |editor2-last=Pavlek |editor2-first=Tea |editor3-last=Erjavec |editor3-first=Jana |title=Introduction to Laboratory Software Solutions and Differences Between Them |url=https://onlinelibrary.wiley.com/doi/10.1002/9783527825042.ch3 |work=Digital Transformation of the Laboratory |language=en |edition=1 |publisher=Wiley |pages=75–84 |doi=10.1002/9783527825042.ch3 |isbn=978-3-527-34719-3 |accessdate=2024-03-12}}</ref> This typically is initiated when a sample is received in the laboratory, at which point the sample will be registered in the LIMS. This registration process may involve [[Accessioning (medical)|accessioning]] the sample and producing [[Barcode|barcodes]] to affix to the sample container. Various other parameters, such as clinical or phenotypic [[information]] corresponding with the sample, are also often recorded.<ref name="KranjcIntro21" /> The LIMS can then track a sample's progress throughout the lab and its workflow. In many cases, location tracking can be quite granular, down to a particular freezer location, even down to the level of shelf, rack, box, row, and column. Beyond location, other aspects of and actions upon the sample can be tracked and time-stamped, including freeze and thaw cycles that a sample undergoes, [[Aliquot|aliquoting]] of the sample, and more.


Modern LIMS have implemented extensive configurability, as each laboratory's needs for tracking additional data points can vary widely. LIMS vendors cannot typically make assumptions about what these data tracking needs are, and therefore vendors often create LIMS that are adaptable to individual environments. This typically involves the inclusion of workflow management tools in the LIMS. Users may also have regulatory concerns to comply with such as [[CLIA]], [[HIPAA]], [[21 CFR Part 11]], good laboratory practice (GLP), and FDA specifications, affecting certain aspects of sample management in a LIMS solution.<ref name="KranjcIntro21" /><ref name="RegCompLIMS">{{cite web |url=https://www.designworldonline.com/Regulatory-compliance-drives-LIMS/ |title=Regulatory compliance drives LIMS |author=Zipp, K. |work=Design World |publisher=WTWH Media, LLC |date=21 February 2007 |accessdate=12 March 2024}}</ref><ref name="BoyarLab21">{{Citation |last=Boyar |first=Kyle |last2=Pham |first2=Andrew |last3=Swantek |first3=Shannon |last4=Ward |first4=Gary |last5=Herman |first5=Gary |date=2021 |editor-last=Opie |editor-first=Shaun R. |title=Laboratory Information Management Systems (LIMS) |url=http://link.springer.com/10.1007/978-3-030-62716-4_7 |work=Cannabis Laboratory Fundamentals |language=en |publisher=Springer International Publishing |place=Cham |pages=131–151 |doi=10.1007/978-3-030-62716-4_7 |isbn=978-3-030-62715-7 |accessdate=2024-03-12}}</ref><ref name="FamiliLab22">{{Citation |last=Famili |first=Parsa |last2=Cleary |first2=Susan |date=2022-03-09 |editor-last=Huynh‐Ba |editor-first=Kim |title=Laboratory Information Management System (LIMS) and Electronic Data |url=https://onlinelibrary.wiley.com/doi/10.1002/9781119680475.ch10 |work=Analytical Testing for the Pharmaceutical GMP Laboratory |language=en |edition=1 |publisher=Wiley |pages=345–373 |doi=10.1002/9781119680475.ch10 |isbn=978-1-119-12091-9 |accessdate=2024-03-12}}</ref> In the end, an analytical lab's deliverables are the results of its analyses of samples and specimens; it's imperative they are timely, accurate, and of good provenance. At the core of any modern sample management activities is the concept of "[[data integrity]]", and a LIMS' ability to track sample-related data and metadata at every step of the laboratory workflow from the point of origin (thanks to instrument integration functionality<ref name="KranjcIntro21" />; see next subsection), all while using [[audit trail]] and [[electronic signature]] functionality, positively lends to a lab's overall approach to data integrity and producing accurate, defensible results.<ref name="FamiliLab22" /><ref name="McDowallHowCan16">{{cite journal |url=https://www.chromatographyonline.com/view/how-can-lims-help-ensure-data-integrity |title=How Can LIMS Help Ensure Data Integrity? |author=McDowall, R.D. |journal=LCGC Europe |volume=29 |issue=6 |pages=310–16 |year=2016 |accessdate=12 March 2024}}</ref>
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" />


====Instrument and application integration====
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>
Modern LIMS offer integration with laboratory instruments, a desirable feature for data integrity purposes.<ref name="KranjcIntro21" /> This used to be a costly and time-consuming process<ref name="Lanewala2024LIMS24" /><ref name="John3504HL7_11">{{cite web |url=https://community.spiceworks.com/topic/175107-hl7-interface-cost-and-maintenance |title=HL7 Interface cost and maintenance |author=John3504 |work=Spiceworks |date=07 December 2011 |accessdate=12 March 2024}}</ref><ref name="MLOStaffInterf12">{{cite web |url=https://www.mlo-online.com/home/article/13004490/interfacing-the-lis |title=Interfacing the LIS |author=MLO Staff |work=Medical Laboratory Observer |date=01 August 2012 |accessdate=12 March 2024}}</ref><ref name="DuckworthITIn">{{cite web |url=https://www.laboratorynetwork.com/doc/it-in-the-lab-the-instrument-interface-revisi-0002 |title=IT in the Lab: The Instrument Interface... Revisited |author=Duckworth, J. |work=Laboratory Network |accessdate=28 February 2024}}</ref>, setting up a control file on an instrument-by-instrument basis, which would "feed" into the instrument and direct its operation on some physical item such as a sample tube or sample plate. The LIMS would then import instrument results files back into the system and extract data for quality control assessment of the operation on the sample. The rise of modular, pre-configured [[middleware]] solutions that can from the start interface a series of device and device types to a LIMS more efficiently has in small part lessened this burden for LIMS users, however.<ref name="Lanewala2024LIMS24" /><ref name="MLOStaffInterf12" /> In all cases, the LIMS may also limit access to that instrument data fed into the system based on chain of custody assignments or other security features if need be.


In addition, a LIMS typically allows for the import and management of raw assay data results.<ref name="LBAssays">{{cite book |title=Ligand-Binding Assays: Development, Validation, and Implementation in the Drug Development Arena |author=Khan, Masood N.; Findlay, John W. |chapter=11.6 Integration: Tying It All Together |year=2009 |pages=324 |publisher=John Wiley & Sons |url=https://books.google.com/books?id=QzM0LUMfdAkC |isbn=0470041382 |accessdate=21 March 2020}}</ref> Modern targeted assays such as qPCR and deep [[sequencing]] can produce tens of thousands of data points per sample, all while the qPCR instrument is difficult itself to directly interface with the LIMS.<ref name="KranjcIntro21" /> Furthermore, in the case of drug and diagnostic development, a dozen or more assays may be run for any given sample. As such, the LIMS ideally will still provide a means to import raw data files extracted from instruments like qPCR even if the instrument itself can't be directly interfaced. However, in order to track and make usable this imported data, a LIMS solution needs to be adaptable to many different assay formats at both the data layer and import creation layer, while maintaining a high level of overall performance.
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=https://clpmag.com/lab-essentials/information-technology/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=06 January 2022}}</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=https://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=06 January 2022}}</ref>


Increasingly, a LIMS also provides the ability to integrate with other third-party applications such as ELNs, [[enterprise resource planning]] (ERP) systems, or regulatory compliance systems (such as [[Seed-to-sale|seed-to-sale]] reporting systems for [[wikipedia:Cannabis|cannabis]] testing).<ref name="KranjcIntro21" /><ref name="CSols10Ways17">{{cite web |url=https://www.csolsinc.com/blog/10-ways-lims-can-automate-lab/ |title=10 Ways LIMS Can Automate Your Lab |publisher=CSols, Inc |date=09 February 2017 |accessdate=12 March 2024}}</ref><ref name="AudinoManaging18">{{cite web |url=https://cannabisindustryjournal.com/feature_article/managing-cannabis-testing-lab-workflows-using-lims/ |title=Managing Cannabis Testing Lab Workflows using LIMS |author=Audino, S. |work=Cannabis Industry Journal |date=07 February 2018 |accessdate=12 March 2024}}</ref> This integration is typically achieved through the use of an [[application programming interface]] (API)<ref name="CSols10Ways17" /><ref name="AudinoManaging18" /><ref name="BerezinTenSimp23">{{Cite journal |last=Berezin |first=Casey-Tyler |last2=Aguilera |first2=Luis U. |last3=Billerbeck |first3=Sonja |last4=Bourne |first4=Philip E. |last5=Densmore |first5=Douglas |last6=Freemont |first6=Paul |last7=Gorochowski |first7=Thomas E. |last8=Hernandez |first8=Sarah I. |last9=Hillson |first9=Nathan J. |last10=King |first10=Connor R. |last11=Köpke |first11=Michael |date=2023-12-07 |editor-last=Markel |editor-first=Scott |title=Ten simple rules for managing laboratory information |url=https://dx.plos.org/10.1371/journal.pcbi.1011652 |journal=PLOS Computational Biology |language=en |volume=19 |issue=12 |pages=e1011652 |doi=10.1371/journal.pcbi.1011652 |issn=1553-7358 |pmc=PMC10703290 |pmid=38060459}}</ref>, code which serves as an interface between different software programs and databases, and facilitates their interactions.
==LIS vendors==
 
See the [[LIS vendor]] page for a list of LIS vendors past and present.
====Electronic data exchange====
The exponentially growing volume of data created in laboratories, coupled with increased business demands and focus on profitability, have pushed LIMS vendors to increase attention to how their LIMS handles the electronic exchange of data with other systems and instruments. The effectiveness of this data exchange is highly important to regulated industries that regularly report to an authority, as found with cannabis testing and some U.S. states' reporting requirements<ref name="AudinoManaging18" />, as well as clinical labs reporting to state- and federal-based public health agencies.<ref>{{Cite journal |last=Rajamani |first=Sripriya |last2=Kayser |first2=Ann |last3=Emerson |first3=Emily |last4=Solarz |first4=Sarah |date=2018-09-21 |title=Evaluation of Data Exchange Process for Interoperability and Impact on Electronic Laboratory Reporting Quality to a State Public Health Agency |url=https://journals.uic.edu/ojs/index.php/ojphi/article/view/9317 |journal=Online Journal of Public Health Informatics |volume=10 |issue=2 |doi=10.5210/ojphi.v10i2.9317 |issn=1947-2579 |pmc=PMC6194099 |pmid=30349622}}</ref> (Many labs' electronic systems' ability to exchange data with public health agencies was put to the test during the height of the [[COVID-19]] [[pandemic]].<ref name="DouglasWorkflow21">{{cite book |url=https://www.limswiki.org/index.php/LII:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases) |title=COVID-19 Testing, Reporting, and Information Management in the Laboratory |chapter=4. Workflow and information management for COVID-19 (and other respiratory diseases) |author=Douglas, S.E. |publisher=LIMSwiki |edition=Fall 2021 |date=September 2021 |accessdate=12 March 2024}}</ref> In some cases, academic clinical research labs with the means to test patients using their qPCR devices simply couldn't exchange data with health systems' [[electronic health records]] [EHRs], which ultimately excluded those labs from assisting with COVID-19 testing.<ref name="MaxmenThousands20">{{cite journal |title=Thousands of coronavirus tests are going unused in US labs |journal=Nature |author=Maxmen, A. |volume=580 |issue=7803 |pages=312–13 |year=2020 |doi=10.1038/d41586-020-01068-3 |pmid=32273619}}</ref>)
 
In particular, attention must be paid to how an instrument's input and output data is managed, how remote sample collection data is imported and exported, and how mobile and other third-party applications integrate with the LIMS. The successful transfer of data files in a wide variety of formats (including interoperable nonproprietary file types for better meeting the FAIR principles of making data and information more findable, accessible, interoperable, and reusable<ref name="BerezinTenSimp23" />), while maintaining the associated metadata and keeping it secure, is paramount. Historically speaking, the transition "from proprietary databases to standardized database management systems such as Oracle ... and SQL" has had significant impact on how data is managed and exchanged in laboratories<ref name="WoodCompLabInfo">{{cite web |url=https://www.it.uu.se/edu/course/homepage/lims/vt12/ComprehensiveLaboratoryInformatics.pdf |archiveurl=https://web.archive.org/web/20170825181932/https://www.it.uu.se/edu/course/homepage/lims/vt12/ComprehensiveLaboratoryInformatics.pdf |format=PDF |title=Comprehensive Laboratory Informatics: A Multilayer Approach |author=Wood, S. |work=American Laboratory |page=1 |date=September 2007 |archivedate=25 August 2017 |accessdate=12 March 2024}}</ref>, culminating today in cloud-based relational and NOSQL databases that can be set up, operated, and scaled with relative ease.<ref name="AWSAmazonRDS">{{cite web |url=https://aws.amazon.com/rds/ |title=Amazon Relational Database Service (RDS) |publisher=Amazon Web Services, Inc |accessdate=12 March 2024}}</ref><ref name="LardinoisGoogle17">{{cite web |url=https://techcrunch.com/2017/02/14/google-launches-cloud-spanner-a-new-globally-distributed-database-service/ |title=Google launches Cloud Spanner, its new globally distributed relational database service |author=Lardionois, F. |work=TechCrunch |publisher=Oath, Inc |date=14 February 2017 |accessdate=12 March 2024}}</ref>
 
====Additional functions====
In addition to the key functions of sample management, instrument and application integration, and electronic data exchange, there are numerous additional laboratory-based operations that can be managed in a LIMS. This includes but is not limited to<ref name="ASTM_E1578">{{cite web |url=https://www.astm.org/e1578-18.html |title=ASTM E1578-18 Standard Guide for Laboratory Informatics |publisher=ASTM International |date=23 August 2019 |accessdate=12 March 2024}}</ref><ref name="DouglasKeyLIMSFood22">{{cite web |url=https://www.limswiki.org/index.php/LIMS_Q%26A:What_are_the_key_elements_of_a_LIMS_for_food_and_beverage_testing%3F |title=LIMS Q&A:What are the key elements of a LIMS for food and beverage testing? |author=Douglas, S.E. |work=LIMSwiki |date=September 2022 |accessdate=12 March 2024}}</ref><ref name="DouglasLIMSpec22">{{cite web |url=https://www.limswiki.org/index.php/LII:LIMSpec_2022_R2 |title=LII:LIMSpec 2022 R2 |author=Douglas, S.E. |work=LIMSwiki |date=December 2022 |accessdate=12 March 2024}}</ref><ref name="DouglasWhatKeyISO23">{{cite web |url=https://www.limswiki.org/index.php/LIMS_Q%26A:What_are_the_key_elements_of_a_LIMS_to_better_comply_with_ISO/IEC_17025%3F |title=LIMS Q&A:What are the key elements of a LIMS to better comply with ISO/IEC 17025? |author=Douglas, S.E. |work=LIMSwiki |date=January 2023 |accessdate=12 March 2024}}</ref>:
 
'''Test, sample, and result management'''
 
*End-to-end sample and inventory management and tracking
*Complete capture of a registered sample's data and metadata
*Unique sample identifiers
*Sample batching
*Free-form reception-based sample data
*Barcode and RFID support
*Pre-defined and configurable common and industry-specific sample types, tests, methods, and protocols
*Pre-defined and configurable industry-specific workflows
*Robust sampling and test method development
*Configurable screens and data fields
*Specification management
*Test, sampling, instrument, etc. scheduling and assignment
*Test requesting
*Data import and export
*Robust query tools
*Analytical tools, including data visualization, statistical analysis, and data mining tools
*Project management
*Investigation management
*Facility and sampling site management
*Storage management and monitoring
 
'''Quality, security, and compliance'''
 
*Quality assurance / quality control mechanisms
*Multi-level review of test results
*Validation of sampling and test methods
*Audit trails and chain of custody support
*Support for mapping professional requirements to existing system tasks, sample types, and methods
*Instrument lock-out
*Consistent, retrievable calibration and maintenance records
*Calibration activity linkages
*Calibration and maintenance audit trail
*Incident, nonconformance, and deviation notification, tracking, and management
*Statistical trending and control charts
*Internal and external audit management
*Secure backup and retrieval
*Facility monitoring
*Environmental monitoring
*Data retention and encryption
*Robust system security
*LIMS validation
*Secure granular access
*Logical and physical access control
*Electronic signature support
*Status updates and alerts
 
'''Operations management and reporting'''
 
*Document and image management, with versioning and release controls
*Controlled document access
*Provision of the most current document version
*User manuals and training documentation
*Support for unique document identifiers
*Support for training and certification records
*Complaint and problem management
*Unique identification of instruments
*Support for scheduled, frequency-based calibration and maintenance
*Support for data importing and exporting of a variety of formats, including interoperable nonproprietary file types
*Support for data and metadata archiving
*Support for rapid and accurate retrieval of archived data and metadata
*Support for certificates of analysis or similar verification documents
*Support for changed, amended, or re-issued reports
*Configurable dashboards for monitoring, by product, process, facility, etc.
*Industry-compliant reporting and labeling
*Email integration
*Instrument interfacing and data management
*Third-party software and database interfacing
*Supplier/vendor/customer management
*Integrated (or online) system help
 
===LIMS architecture and delivery methods===
A LIMS has historically over many decades depended on a variety of architectures and distribution models for its implementation and use. As technology has changed, how a LIMS is installed, managed, and used has also changed with it. The following represents architectures which have been utilized at one point or another.
 
====Thick-client====
A thick-client LIMS is a more traditional client/server architecture, with some of the system residing on the computer or workstation of the user (the client) and the rest on the server. The LIMS software is installed on the client computer, which does all of the data processing. Later it passes information to the server, which has the primary purpose of data storage. Most changes, upgrades, and other modifications will happen on the client side.
 
This was one of the first architectures implemented into a LIMS, having the advantage of providing higher processing speeds (because processing is done on the client and not the server) and slightly more security (as access to the server data is limited only to those with client software). Additionally, thick-client systems have also provided more interactivity and customization, though often at a greater learning curve. The disadvantages of client-side LIMS include the need for more robust client computers and more time-consuming upgrades, as well as a lack of base functionality through a web browser. The thick-client LIMS can become web-enabled through an add-on component.<ref name="SciComp">{{cite web |url=https://www.scientificcomputing.com/article/2008/08/selecting-right-lims |archiveurl=https://web.archive.org/web/20160829104930/https://www.scientificcomputing.com/article/2008/08/selecting-right-lims |title=Selecting the Right LIMS: Critiquing technological strengths and limitations |author=O'Leary, K.M. |work=Scientific Computing |publisher=Advantage Business Media |date=11 August 2008 |archivedate=29 August 2016 |accessdate=12 March 2024}}</ref><ref name="LabVantageDifInTech">{{cite web |url=http://www.labvantage.com/resources/pdf/whitepapers/ThinClient1101JY21CYL.pdf |archiveurl=https://web.archive.org/web/20140227052508/http://www.labvantage.com/resources/pdf/whitepapers/ThinClient1101JY21CYL.pdf |format=PDF |title=How Differences in Technology Affect LIMS Functionality, Cost, & ROI |publisher=LabVantage Solutions, Inc |date=2011 |pages=2–3 |archivedate=27 February 2014 |accessdate=12 March 2024}}</ref>
 
'''Web-enabled'''
 
A web-enabled LIMS architecture is essentially a thick-client architecture with an added web browser component. In this setup, the client-side software has additional functionality that allows users to interface with the software through their device's browser. This functionality is typically limited only to certain functions of the web client. The primary advantage of a web-enabled LIMS is the end-user can access data both on the client side and the server side of the configuration. As in a thick-client architecture, updates in the software must be propagated to every client machine. However, the added disadvantages of requiring always-on access to the host server and the need for cross-platform functionality mean that additional overhead costs may arise.<ref name="SciComp" /><ref name="LabVantageDifInTech" />
 
====Thin-client====
[[File:Cloud computing.svg|right|thumb|360px|The concept of cloud computing is one of the most recent architecture and delivery models to affect LIMS.]]A thin-client LIMS is a more modern architecture which offers full application functionality accessed through a device's web browser. The actual LIMS software resides on a server (host) which feeds and processes information without saving it to the user's hard disk. Any necessary changes, upgrades, and other modifications are handled by the entity hosting the server-side LIMS software, meaning all end-users see all changes made. To this end, a true thin-client LIMS will leave no "footprint" on the client's computer, and only the integrity of the web browser need be maintained by the user. The advantages of this system include significantly lower cost of ownership and fewer network and client-side maintenance expenses. However, this architecture has the disadvantage of requiring real-time server access, a need for increased network throughput, and slightly less functionality. A sort of hybrid architecture that incorporates the features of thin-client browser usage with a thick client installation exists in the form of a web-based LIMS.<ref name="SciComp" /><ref name="LabVantageDifInTech" />
 
Additionally, maintenance support and warranty (MSW) agreements are usually offered with thin-client installations. Pricing levels are typically based on a percentage of the license fee, with a standard level of service for 10 concurrent users being approximately 10 hours of support and additional customer service at a set per-hour rate. Though some may choose to opt out of an MSW after the first year, it's often more economical to continue the plan in order to receive updates to the LIMS, giving it a longer life span in the laboratory.
 
'''Cloud and SaaS'''
 
In the early 2010s, LIMS vendors began to rent hosted, thin-client solutions as "[[Software as a service|software as a service]]" (SaaS). These cloud-based solutions tended to be less configurable than on-premise solutions and were therefore considered for less demanding implementations such as laboratories with few users and limited sample processing volumes. However, cloud-based software has seen greater adoption as the technology has improved, and configurable LIMS for laboratory operations big and small have become a more realistic option.<ref name="KnippenbergMoving17" /><ref name="JoyceWhatYou17" /><ref name="AstrixProgress22" /><ref name="Lanewala2024LIMS24" /> For example, a June 2022 report published by Astrix Technology found that of life science organizations surveyed, 78 percent of them indicated they have adopted and used or plan to adopt and use cloud-based applications; of all respondents, 43 percent said they are taking a cloud-first or cloud-only approach to its laboratory applications.<ref name="AstrixProgress22" />
 
====Web-based====
Arguably one of the most confusing architectures, web-based LIMS architecture is a hybrid of the thick- and thin-client architectures. While much of the client-side work is done through a web browser, the LIMS also requires the additional support of Microsoft's .NET Framework technology installed on the client device. The end result is a process that is apparent to the end-user through the Microsoft-compatible web browser, but perhaps not so apparent as it runs thick-client-like processing in the background. In this case, web-based architecture has the advantage of providing more functionality through a more friendly web interface. The disadvantages of this setup are more sunk costs in system administration and support for Internet Explorer and .NET technologies, and reduced functionality on mobile platforms.<ref name="SciComp" /><ref name="LabVantageDifInTech" />
 
==The distinction between a LIMS and a LIS==
Historically, the LIMS and LIS have exhibited a few key differences, making them noticeably separate entities<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=13 March 2024}}</ref>:
 
1. A LIMS traditionally has been designed to process and report data related to batches of samples from biology labs, water treatment facilities, drug trials, and other entities that handle complex batches of data. A LIS has been designed primarily for processing and reporting data related to individual patients in a clinical setting.<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=13 March 2024}}</ref><ref name="analytica">{{cite web |url=https://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=13 March 2024}}</ref>
 
2. A LIMS 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. A LIS, however, must satisfy the reporting and auditing needs of [[hospital]] accreditation agencies, [[HIPAA]], and other clinical medical practitioners.<ref name="lislims1" />
 
3. A LIMS is most competitive in group-centric settings (dealing with "batches" and "samples") that often deal with mostly anonymous research-specific laboratory data, whereas a LIS is usually most competitive in patient-centric settings (dealing with "subjects" and "specimens") and clinical labs.<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=13 March 2024}}</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=13 March 2024}}</ref>
 
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 a LIS, blurring the lines between the two components further.<ref name="starlims" /> [[Thermo Scientific]]'s Clinical LIMS was an example of this merger of LIMS with LIS, 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=https://clpmag.com/lab-essentials/information-technology/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=13 March 2024}}</ref> [[Abbott Informatics Corporation]]'s STARLIMS product was another example of this LIMS/LIS 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 a LIS and a LIMS? |author=Jones, J. |publisher=LinkedIn |date=March 2012 |accessdate=13 March 2024}}</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}}{{Dead link}}</ref> {{As of|2024}}, 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 a 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=13 March 2024}}</ref><ref name="ReisenwitzWhatIs17">{{cite web |url=https://www.capterra.com/resources/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=13 March 2024}}</ref><ref name="CloudLISDifference16">{{cite web |url=https://cloudlims.com/lims-vs-lis/ |title=LIS vs LIMS: Uncover the Difference & Choose the Right Informatics Solution |publisher=CloudLIMS.com, LLC |date=12 October 2023 |accessdate=13 March 2024}}</ref>
 
==Standards affecting LIMS==
A LIMS' development and use is affected by standards such as:
 
*[[21 CFR Part 11|Title 21 CFR Part 11]] from the [[Food and Drug Administration]] (United States)
*[[ISO 17025]]
*[[ISO 15189]]
*[[Good laboratory practice]]
 
==LIMS vendors==
 
See the [[LIMS vendor]] page for a list of LIMS vendors past and present.


==See also==
==See also==
*[[Laboratory informatics]]
*[[Laboratory informatics]]
*[[LIMS feature|Common LIMS features]]
*[[LIS feature|Common LIS features]]
 
==Further reading==
 
* {{cite journal |title=A brief history of LIMS |journal=Laboratory Automation and Information Management|author=Gibbon, G.A. |volume=32 |issue=1 |pages=1–5 |year=1996 |doi=10.1016/1381-141X(95)00024-K}}


* {{cite web |url=https://www.it.uu.se/edu/course/homepage/lims/vt12/ComprehensiveLaboratoryInformatics.pdf |archiveurl=https://web.archive.org/web/20170825181932/https://www.it.uu.se/edu/course/homepage/lims/vt12/ComprehensiveLaboratoryInformatics.pdf |format=PDF |title=Comprehensive Laboratory Informatics: A Multilayer Approach |author=Wood, S. |work=American Laboratory |page=1 |date=September 2007 |archivedate=25 August 2017}}
== Further reading ==
* {{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}}
* {{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}}
==References==
==References==
{{Reflist|colwidth=30em}}
{{Reflist|colwidth=30em}}
<!---Place all category tags here-->
<!---Place all category tags here-->

Revision as of 22:08, 13 March 2024

This is sublevel12 of my sandbox, where I play with features and test MediaWiki code. If you wish to leave a comment for me, please see my discussion page instead.

Sandbox begins below

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. (9 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. (1 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. (4 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. https://www.analytica-world.com/en/news/35566/lims-lis-market-and-poct-supplement.html. Retrieved 06 January 2022. 
  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. (1 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. (1 February 2012). "Convergence of LIMS and LIS". Clinical Lab Products. MEDQOR. https://clpmag.com/lab-essentials/information-technology/convergence-of-lims-and-lis/. Retrieved 06 January 2022. 
  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. 1 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. https://blog.capterra.com/what-is-a-laboratory-information-management-system/. Retrieved 06 January 2022. 


Retrieved from "https://www.limswiki.org/index.php?title=User:Shawndouglas/sandbox/sublevel12&oldid=58757"