Difference between revisions of "User:Shawndouglas/sandbox/sublevel4"

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Today, many laboratorians and laboratory informatics vendors use “LIMS” and “LIS” interchangeably. Historically, however, the term "LIMS" has tended to be used to reference informatics systems targeted for environmental, research, or commercial analysis such as pharmaceutical or petrochemical work. "LIS" has tended to be used to reference laboratory informatics systems in the forensics and clinical markets, which often require special case management tools.  
A LIMS can have an extravagant list of features, or it may have minimal functionality. Experienced software developers usually do well to include a collection of the essential features, as well as any industry-specific features a laboratory may need. However, not all developers get it right. A generic development approach to a clinical diagnostic or research LIMS may not suffice, given that workflows and regulatory requirements may differ across the various clinical care and research laboratory subtypes.


While the distinction between the two has faded in the last decade<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><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>, a few fundamental differences remain. The LIS is largely designed to:
What follows is a list of system functionality that is considered by a variety of laboratory experts<ref name="APHLLab19">{{cite web |url=https://www.aphl.org/aboutAPHL/publications/Documents/GH-2019May-LIS-Guidebook-web.pdf |format=PDF |title=Laboratory Information Systems Project Management: A Guidebook for International Implementations |author=Association of Public Health Laboratories |publisher=APHL |date=May 2019 |accessdate=18 November 2021}}</ref><ref name="KyobeSelecting17">{{cite journal |title=Selecting a Laboratory Information Management System for Biorepositories in Low- and Middle-Income Countries: The H3Africa Experience and Lessons Learned |journal=Biopreservation and Biobanking |author=Kyobe, S.; Musinguzi, H.; Lwanga, N. et al. |volume=15 |issue=2 |pages=111–15 |year=2017 |doi=10.1089/bio.2017.0006 |pmc=PMC5397240}}</ref><ref name="ListEffic14">{{cite journal |title=Efficient sample tracking with OpenLabFramework |journal=Scientific Reports |author=List, M.; Schmidt, S.; Trojnar, J. et al. |volume=4 |pages=4278 |year=2014 |doi=10.1038/srep04278 |pmid=24589879 |pmc=PMC3940979}}</ref><ref name="APILISTool13">{{cite web |url=https://www.pathologyinformatics.org/toolkit.php |title=LIS Functionality Assessment Toolkit |author=Splitz, A.R.; Balis, U.J.; Friedman, B.A. et al. |publisher=Association for Pathology Informatics |date=20 September 2013 |accessdate=18 November 2021}}</ref> to be vital to almost any clinical diagnostic or research laboratory. Without this functionality, end users may have to do more work, and the laboratory may have major liability issues by not complying with regulations. If the system you are evaluating doesn't contain most of the below bullet-pointed functionality, you may want to look elsewhere.


* Process and report specimens from patients in clinical settings.
* Handle the reporting and auditing requirements of accrediting and regulating agencies.
* Manage sensitive patient and clinical trial participant data.


The LIMS, on the other hand, is typically designed to process and report samples and sample batches from non-human sources while conforming to sampling, testing and manufacturing standards.  
'''Test, experiment and patient management'''
* Specimen log-in and management, with support for unique IDs.
* Batching support.
* Barcode and RFID support.
* Specimen tracking.
* Clinical decision support, including test ordering tools and duplicate test checks.
* Custom test management.
* Event and instrument scheduling.
* Templates, forms and data fields that are configurable.
* Analytical tools, including data visualization, trend analysis and data mining tools.
* Data import and export.
* Robust query tools.
* Document and image management.
* Project and experiment management.
* Workflow management.
* Patient management.
* Case management.
* Physician and supplier management.


However, some LIMSs have evolved and broadened their service scope to address the needs of clinical diagnostic and research laboratories. The end result: more LIMS are filling the needs of labs where a LIS was traditionally used. The clinical lab seeking a laboratory informatics solution will therefore want to consider the features and functionality of a system regardless of its moniker.
 
'''Quality, security and compliance'''
* Quality assurance / quality control mechanisms, including tracking of nonconformance.
* Data normalization and validation.
* Results review and approval.
* Version control.
* User qualification, performance and training management.
* Audit trails and chain of custody support.
* Configurable and granular role-based security.
* Configurable system access and use (log-in requirements, account usage rules, account locking, etc.).
* Electronic signature support.
* Configurable alarms and alerts.
* Data encryption and secure communication protocols.
* Data archiving and retention support.
* Configurable data backups.
* Environmental monitoring and control.
 
 
'''Operations management and reporting'''
* Customizable rich-text reporting, with multiple supported output formats.
* Synoptic reporting.
* Industry-compliant labeling.
* Email integration.
* Internal messaging system.
* Revenue management.
* Instrument interfacing and data management.
* Instrument calibration and maintenance tracking.
* Inventory and reagent management.
* Third-party software and database interfacing.
* Mobile device support.
* Voice recognition capability.
* Results portal for external parties.
* Integrated (or online) system help.
* Configurable language.


==References==
==References==
{{Reflist|colwidth=30em}}
{{Reflist|colwidth=30em}}

Revision as of 16:37, 9 March 2022

A LIMS can have an extravagant list of features, or it may have minimal functionality. Experienced software developers usually do well to include a collection of the essential features, as well as any industry-specific features a laboratory may need. However, not all developers get it right. A generic development approach to a clinical diagnostic or research LIMS may not suffice, given that workflows and regulatory requirements may differ across the various clinical care and research laboratory subtypes.

What follows is a list of system functionality that is considered by a variety of laboratory experts[1][2][3][4] to be vital to almost any clinical diagnostic or research laboratory. Without this functionality, end users may have to do more work, and the laboratory may have major liability issues by not complying with regulations. If the system you are evaluating doesn't contain most of the below bullet-pointed functionality, you may want to look elsewhere.


Test, experiment and patient management

  • Specimen log-in and management, with support for unique IDs.
  • Batching support.
  • Barcode and RFID support.
  • Specimen tracking.
  • Clinical decision support, including test ordering tools and duplicate test checks.
  • Custom test management.
  • Event and instrument scheduling.
  • Templates, forms and data fields that are configurable.
  • Analytical tools, including data visualization, trend analysis and data mining tools.
  • Data import and export.
  • Robust query tools.
  • Document and image management.
  • Project and experiment management.
  • Workflow management.
  • Patient management.
  • Case management.
  • Physician and supplier management.


Quality, security and compliance

  • Quality assurance / quality control mechanisms, including tracking of nonconformance.
  • Data normalization and validation.
  • Results review and approval.
  • Version control.
  • User qualification, performance and training management.
  • Audit trails and chain of custody support.
  • Configurable and granular role-based security.
  • Configurable system access and use (log-in requirements, account usage rules, account locking, etc.).
  • Electronic signature support.
  • Configurable alarms and alerts.
  • Data encryption and secure communication protocols.
  • Data archiving and retention support.
  • Configurable data backups.
  • Environmental monitoring and control.


Operations management and reporting

  • Customizable rich-text reporting, with multiple supported output formats.
  • Synoptic reporting.
  • Industry-compliant labeling.
  • Email integration.
  • Internal messaging system.
  • Revenue management.
  • Instrument interfacing and data management.
  • Instrument calibration and maintenance tracking.
  • Inventory and reagent management.
  • Third-party software and database interfacing.
  • Mobile device support.
  • Voice recognition capability.
  • Results portal for external parties.
  • Integrated (or online) system help.
  • Configurable language.

References

  1. ↑ Association of Public Health Laboratories (May 2019). "Laboratory Information Systems Project Management: A Guidebook for International Implementations" (PDF). APHL. https://www.aphl.org/aboutAPHL/publications/Documents/GH-2019May-LIS-Guidebook-web.pdf. Retrieved 18 November 2021. 
  2. ↑ Kyobe, S.; Musinguzi, H.; Lwanga, N. et al. (2017). "Selecting a Laboratory Information Management System for Biorepositories in Low- and Middle-Income Countries: The H3Africa Experience and Lessons Learned". Biopreservation and Biobanking 15 (2): 111–15. doi:10.1089/bio.2017.0006. PMC PMC5397240. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5397240. 
  3. ↑ List, M.; Schmidt, S.; Trojnar, J. et al. (2014). "Efficient sample tracking with OpenLabFramework". Scientific Reports 4: 4278. doi:10.1038/srep04278. PMC PMC3940979. PMID 24589879. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3940979. 
  4. ↑ Splitz, A.R.; Balis, U.J.; Friedman, B.A. et al. (20 September 2013). "LIS Functionality Assessment Toolkit". Association for Pathology Informatics. https://www.pathologyinformatics.org/toolkit.php. Retrieved 18 November 2021. 
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