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

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[[File:FISH (Fluorescent In Situ Hybridization).jpg|right|550px]]The molecular diagnostics lab will use one or more techniques (e.g., PCR, DNA sequencing, microarrays, gene expression profiling and cytogenetics) in their workflow, and the LIMS used in molecular diagnostics ideally will address those workflow needs. This is especially true for cytogenetics labs, which use specialty techniques like chromosome analysis or karyotyping, fluorescence ''in situ'' hybridization (FISH) and microarray-based assays such as comparative genomic hybridization.<ref name="AACCGenetic19">{{cite web |url=https://www.testing.com/genetic-testing-techniques/ |title=Genetic Testing Techniques |work=Testing.com |publisher=OneCare Media |date=09 November 2021 |accessdate=18 November 2021}}</ref><ref name="MayoClinicCyto">{{cite web |url=https://www.mayoclinic.org/departments-centers/laboratory-medicine-pathology/overview/specialty-groups/laboratory-genetics/cytogenetics-laboratory |title=Cytogenetics Laboratory |work=Departments and Centers: Laboratory Medicine and Pathology |publisher=Mayo Clinic |accessdate=18 November 2021}}</ref><ref name="YaleCyto">{{cite web |url=https://medicine.yale.edu/lab/cytogenetics/testing/ |title=Cytogenetics Lab Tests |work=Cytogenetics Lab |publisher=Yale School of Medicine |accessdate=18 November 2021}}</ref>
[[File:COVID-19 vaccine vial AstraZenaca 2021 (UK).jpg|right|300px]]While testing for SARS-CoV-2, the virus that causes COVID-19, is technically a part of clinical diagnostics, it integrates aspects of other lab types, such as clinical pathology and molecular diagnostics. As such, it shouldn’t be surprising that an effective clinical diagnostics LIMS built for COVID-19 testing should include a few unique features outside of a generic clinical LIMS solution. This becomes even more obvious when you consider the mandatory reporting requirements, specialist workflows, and demanding turn-around time (TAT) and accuracy requirements of testing patients for COVID-19.


In addition to the essential features of a standard LIMS, the molecular diagnostics and cytogenetics lab will also be looking for a system that can (or allows users to)<ref name="SunquestMitogen20">{{cite web |url=https://www.sunquestinfo.com/software-and-services/lims/ |title=Sunquest Mitogen LIMS |publisher=Sunquest Information Systems, Inc |date=2021 |accessdate=18 November 2021}}</ref><ref name="XifinMolec20">{{cite web |url=https://www.xifin.com/industry-solutions/laboratory/molecular-diagnostics |title=Molecular Diagnostics |publisher=XIFIN, Inc |date=2021 |accessdate=18 November 2021}}</ref><ref name="PsycheNucleoLIS20">{{cite web |url=https://psychesystems.com/enterprise-laboratory-information-software/nucleolis-molecular-lab-testing-software/ |title=NucleoLIS - Flexible & Modern LIS |publisher=Psyche Systems |date=2021 |accessdate=18 November 2021}}</ref><ref name="MyersLab18">{{cite journal |title=Laboratory Information Systems and Instrument Software Lack Basic Functionality for Molecular Laboratories |journal=Journal of Molecular Diagnostics |author=Myers, C.; Swadley, M.; Carter, A.B. |volume=20 |issue=5 |pages=591–99 |year=2018 |doi=10.1016/j.jmoldx.2018.05.011}}</ref>:
In addition to the essential features of a standard LIMS, the COVID-19 lab will also be looking for a system that can (or allows users to)<ref name="DouglasCOVID21">{{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) |chapter=4. Workflow and information management for COVID-19 (and other respiratory diseases) |title=COVID-19 Testing, Reporting, and Information Management in the Laboratory |author=Douglas, S.E. |date=September 2021}}</ref>:


* Manage sample collection kits.
• Conduct the specialty functions found in a clinical pathology LIMS.
* Manage informed consent documentation.
• Conduct the specialty functions found in a molecular diagnostics and cytogenetics LIMS.
* Provide customized workflows for molecular and next-generation sequencing (NGS) testing.
Provide a flexible provider portal that includes disease-specific checks for test necessity.
* Track specimen and aliquot lineage for cell lines, tissues, slides, etc.
Support a wide variety of user, provider and patient data.
* Track nucleic acid quantity and quality of specimens.
• Provide a clear preregistration module that can capture critical patient and facility information, as well as national reporting questions.
* Support a wide array of molecular testing and associated data fields, including biochemical and molecular genetics, carrier screening, immunology, molecular profiling, prenatal and newborn testing, and pharmacogenetics.
• Support queue-based specimen tracking.
* Provide custom workflows for FISH, PCR, gel electrophoresis, cytogenetics, DNA sequencing and more.
• Provide default assays and workflows for SARS-CoV-2 testing.
* Support specialty testing reimbursement and other revenue management unique to this lab type.
• Set up custom workflows for unique SARS-CoV-2 testing.
* Support single sign-on with imaging platforms.
• Set up automatic reflex testing.
* Provide color coding for turn-around time and other testing statuses.
• Interface with most popular complex and point-of-care instruments used in COVID-19 testing.
* Provide cleanly formatted rich-text reports customized for molecular diagnostics.
• Integrate with mandatory results reporting systems and EHRs.
• Ensure efficient, native report delivery via email, fax or provider portal.
Provide a customizable dashboard that can display disease-specific data and information.


==References==
==References==
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Revision as of 18:47, 9 March 2022

COVID-19 vaccine vial AstraZenaca 2021 (UK).jpg

While testing for SARS-CoV-2, the virus that causes COVID-19, is technically a part of clinical diagnostics, it integrates aspects of other lab types, such as clinical pathology and molecular diagnostics. As such, it shouldn’t be surprising that an effective clinical diagnostics LIMS built for COVID-19 testing should include a few unique features outside of a generic clinical LIMS solution. This becomes even more obvious when you consider the mandatory reporting requirements, specialist workflows, and demanding turn-around time (TAT) and accuracy requirements of testing patients for COVID-19.

In addition to the essential features of a standard LIMS, the COVID-19 lab will also be looking for a system that can (or allows users to)[1]:

• Conduct the specialty functions found in a clinical pathology LIMS. • Conduct the specialty functions found in a molecular diagnostics and cytogenetics LIMS. • Provide a flexible provider portal that includes disease-specific checks for test necessity. • Support a wide variety of user, provider and patient data. • Provide a clear preregistration module that can capture critical patient and facility information, as well as national reporting questions. • Support queue-based specimen tracking. • Provide default assays and workflows for SARS-CoV-2 testing. • Set up custom workflows for unique SARS-CoV-2 testing. • Set up automatic reflex testing. • Interface with most popular complex and point-of-care instruments used in COVID-19 testing. • Integrate with mandatory results reporting systems and EHRs. • Ensure efficient, native report delivery via email, fax or provider portal. • Provide a customizable dashboard that can display disease-specific data and information.

References