Difference between revisions of "User:Shawndouglas/sandbox/sublevel1"

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'''High- and moderate-complexity CLIA testing'''
A June 2020 report by Weemaes ''et al.'' in the ''Journal of the American Medical Informatics Association'' describes the bottlenecks they encountered in their test workflows at the Belgian National Reference Center, and how they updated their LIS with functionality to resolve those bottlenecks.<ref name="WeemaesLab20">{{cite journal |title=Laboratory information system requirements to manage the COVID-19 pandemic: A report from the Belgian national reference testing center |journal=JAMIA |author=Weemaes, M.; Martens, S.; Cuypers, L. et al. |at=ocaa081 |year=2020 |doi=10.1093/jamia/ocaa081 |pmid=32348469 |pmc=PMC7197526}}</ref> In addition to adding a COVID-19–specific order set into the [[computerized physician order entry]] (CPOE) module integrated with both their LIS and [[electronic health record]] (EHR), they included an up-to-date triage criteria component, a tool for optimizing sampling and packaging, a COVID-19 status button, and improved reporting modules for automating reference testing and epidemiological reporting. They also added extra database and data mining functionality to facilitate research and insights into epidemiologies and treatments. Their conclusion: "Rapidly developed, agile extendable LIS functionality and its meaningful use alleviates the administrative burden on laboratory personnel and improves turnaround time of SARS-CoV-2 testing."<ref name="WeemaesLab20" /> The Association of Public Health Laboratories comes to a similar conclusion in regard to laboratory informatics solutions and public health laboratories' COVID-19 testing.<ref name="APHLLIMS20">{{cite web |url=https://www.aphl.org/aboutAPHL/publications/Documents/INFO-2020-LIMS.pdf |format=PDF |title=LIMS (Laboratory Information Management System) |author=Association of Public Health Laboratories |publisher= Association of Public Health Laboratories |date=2020 |accessdate=18 August 2020}}</ref>


Non-reagent consumables for high- and moderate-complexity CLIA testing include PCR tubes and plates; pipettes and tips; films, foils, and sealing mats; swabs; and viral transport media, among others. Some like Kellner ''et al.'' have experimented with methods to make isothermal amplifications methods more approachable in resource-poor environments by, for example, developing a pipette-free version of LAMP.<ref name="KellnerARapid20">{{cite journal |title=A rapid, highly sensitive and open-access SARS-CoV-2 detection assay for laboratory and home testing |journal=bioRxiv |author=Kellner, M.J.; Ross, J.J.; Schnabl, J. et al. |year=2020 |doi=10.1101/2020.06.23.166397}}</ref>
As such, adding COVID-19 and other respiratory illness testing to your workflow may necessitate an information management system, or an upgrade of your existing software systems. You may experience many of the same bottlenecks the Belgian National Reference Center experienced, especially if you're still working primarily with paper-based test ordering. Those researchers found that paper-based COVID-19 test requests often<ref name="WeemaesLab20" />:


'''CLIA-waived testing'''
* omitted critical clinical status and contact information;
* slowed down epidemiological and research studies;
* hindered proper pre-analytical biosafety procedures; and
* impeded rapid response to evolving test criteria and clinical insights through test ordering protocols.


The FDA EUA devices (Table 1 and 2) may require a few extra consumables. For example, the Accula SARS-CoV-2 test kit comes with swabs<ref name="MBAccula20">{{cite web |url=https://www.fda.gov/media/136355/download |format=PDF |title=Accula Test |publisher=Mesa Biotech, Inc |date=April 2020 |accessdate=16 August 2020}}</ref> and the Xpert Xpress SARS-CoV-2 kit comes with disposable transfer pipettes.<ref name="CepheidXpert20">{{cite web |url=https://www.fda.gov/media/136315/download |format=PDF |title=Xpert Xpress SARS-CoV-2 |publisher=Cepheid |date=March 2020 |accessdate=16 August 2020}}</ref> Refer to the IFU for the waived test kit to determine what additional consumables you'll require.
How interoperable your laboratory software solution is with other systems such as EHRs is also worth consideration. The next chapter addresses system interoperability in greater detail, but it's worth mentioning it here in the context of adding software to improve testing workflows for SARS-CoV-2 and other respiratory viruses. Broadly speaking, improving interoperability among [[clinical informatics]] systems—whether at the point of care or within a specific laboratory—is recognized as an important step towards improving health outcomes.<ref name="KunImprov08">{{cite journal |title=Improving outcomes with interoperable EHRs and secure global health information infrastructure |journal=Studies in Health Technology and Informatics |author=Kun, L.; Coatrieux, G.; Quantin, C. et al. |volume=137 |pages=68–79 |year=2008 |pmid=18560070}}</ref><ref name="GCHIImproving">{{cite web |url=http://s3.amazonaws.com/rdcms-himss/files/production/public/Improving-Patient-Carethrough-Interoperability.pdf |format=PDF |title=Improving Patient Care through Interoperability |author=Global Center for Health Innovation |publisher=Global Center for Health Innovation |date=n.d. |accessdate=16 August 2020}}</ref> However, while developers of EHRs and other clinical informatics systems have intended to improve their software's interoperability, the COVID-19 pandemic has, at times, unfortunately shown the inadequacies still inherent in that software's overall design.<ref name="GlaserItsTime20">{{cite web |url=https://hbr.org/2020/06/its-time-for-a-new-kind-of-electronic-health-record |title=It’s Time for a New Kind of Electronic Health Record |author=Glaser, J. |work=Harvard Business Review |date=12 June 2020 |accessdate=18 August 2020}}</ref><ref name="LimoliPhys20">{{cite web |url=https://medcitynews.com/2020/07/physicians-deserve-better-software-covid-19-has-shown-why-medical-records-need-to-adapt/ |title=Physicians deserve better software: Covid-19 has shown why medical records need to adapt |author=Limoli, C.; Papathomas, G. |work=MedCity News |date=07 July 2020 |accessdate=18 August 2020}}</ref><ref name="JasonEHR20">{{cite web |url=https://ehrintelligence.com/news/ehr-optimization-health-it-projects-needed-after-covid-19-surge |title=EHR Optimization, Health IT Projects Needed After COVID-19 Surge |author=Jason, C. |work=EHR Intelligence |date=23 July 2020 |accessdate=18 August 2020}}</ref><ref name="ReevesTheClin21">{{cite journal |title=The Clinical Information Systems Response to the COVID-19 Pandemic |journal=Yearbook of Medical Informatics |author=Reeves, J.J.; Pageler, N.M.; Wick, E.C. et al. |volume=30 |issue=1 |pages=105–25 |year=2021 |doi=10.1055/s-0041-1726513 |pmid=34479384 |pmc=PMC8416224}}</ref> As such, any research into acquiring a [[laboratory information management system]] (LIMS), LIS, or other clinical information management solution should take into account how well that solution is able to integrate with your other clinical systems, as well as any other third-party systems like physician or hospital EHRs. And it's not just the software solutions you'll want to consider. Will the new instruments you add for getting your lab rolling with clinical respiratory illness testing integrate with your software?
 
Finally, although rare, you may find you don't have the in-house expertise to fully implement a COVID-19 testing line to your laboratory. In such a case, you may need to turn to a laboratory services consultancy with experience in SARS-CoV-2 test method validation, instrument procurement and implementation, and legal matters. (See the next section for a representative example of consultants advertising COVID-19 testing knowledge and services for labs.)


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

Revision as of 19:46, 3 February 2022

A June 2020 report by Weemaes et al. in the Journal of the American Medical Informatics Association describes the bottlenecks they encountered in their test workflows at the Belgian National Reference Center, and how they updated their LIS with functionality to resolve those bottlenecks.[1] In addition to adding a COVID-19–specific order set into the computerized physician order entry (CPOE) module integrated with both their LIS and electronic health record (EHR), they included an up-to-date triage criteria component, a tool for optimizing sampling and packaging, a COVID-19 status button, and improved reporting modules for automating reference testing and epidemiological reporting. They also added extra database and data mining functionality to facilitate research and insights into epidemiologies and treatments. Their conclusion: "Rapidly developed, agile extendable LIS functionality and its meaningful use alleviates the administrative burden on laboratory personnel and improves turnaround time of SARS-CoV-2 testing."[1] The Association of Public Health Laboratories comes to a similar conclusion in regard to laboratory informatics solutions and public health laboratories' COVID-19 testing.[2]

As such, adding COVID-19 and other respiratory illness testing to your workflow may necessitate an information management system, or an upgrade of your existing software systems. You may experience many of the same bottlenecks the Belgian National Reference Center experienced, especially if you're still working primarily with paper-based test ordering. Those researchers found that paper-based COVID-19 test requests often[1]:

  • omitted critical clinical status and contact information;
  • slowed down epidemiological and research studies;
  • hindered proper pre-analytical biosafety procedures; and
  • impeded rapid response to evolving test criteria and clinical insights through test ordering protocols.

How interoperable your laboratory software solution is with other systems such as EHRs is also worth consideration. The next chapter addresses system interoperability in greater detail, but it's worth mentioning it here in the context of adding software to improve testing workflows for SARS-CoV-2 and other respiratory viruses. Broadly speaking, improving interoperability among clinical informatics systems—whether at the point of care or within a specific laboratory—is recognized as an important step towards improving health outcomes.[3][4] However, while developers of EHRs and other clinical informatics systems have intended to improve their software's interoperability, the COVID-19 pandemic has, at times, unfortunately shown the inadequacies still inherent in that software's overall design.[5][6][7][8] As such, any research into acquiring a laboratory information management system (LIMS), LIS, or other clinical information management solution should take into account how well that solution is able to integrate with your other clinical systems, as well as any other third-party systems like physician or hospital EHRs. And it's not just the software solutions you'll want to consider. Will the new instruments you add for getting your lab rolling with clinical respiratory illness testing integrate with your software?

Finally, although rare, you may find you don't have the in-house expertise to fully implement a COVID-19 testing line to your laboratory. In such a case, you may need to turn to a laboratory services consultancy with experience in SARS-CoV-2 test method validation, instrument procurement and implementation, and legal matters. (See the next section for a representative example of consultants advertising COVID-19 testing knowledge and services for labs.)

References

  1. ↑ 1.0 1.1 1.2 Weemaes, M.; Martens, S.; Cuypers, L. et al. (2020). "Laboratory information system requirements to manage the COVID-19 pandemic: A report from the Belgian national reference testing center". JAMIA: ocaa081. doi:10.1093/jamia/ocaa081. PMC PMC7197526. PMID 32348469. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7197526. 
  2. ↑ Association of Public Health Laboratories (2020). "LIMS (Laboratory Information Management System)" (PDF). Association of Public Health Laboratories. https://www.aphl.org/aboutAPHL/publications/Documents/INFO-2020-LIMS.pdf. Retrieved 18 August 2020. 
  3. ↑ Kun, L.; Coatrieux, G.; Quantin, C. et al. (2008). "Improving outcomes with interoperable EHRs and secure global health information infrastructure". Studies in Health Technology and Informatics 137: 68–79. PMID 18560070. 
  4. ↑ Global Center for Health Innovation (21 November 2024). "Improving Patient Care through Interoperability" (PDF). Global Center for Health Innovation. http://s3.amazonaws.com/rdcms-himss/files/production/public/Improving-Patient-Carethrough-Interoperability.pdf. Retrieved 16 August 2020. 
  5. ↑ Glaser, J. (12 June 2020). "It’s Time for a New Kind of Electronic Health Record". Harvard Business Review. https://hbr.org/2020/06/its-time-for-a-new-kind-of-electronic-health-record. Retrieved 18 August 2020. 
  6. ↑ Limoli, C.; Papathomas, G. (7 July 2020). "Physicians deserve better software: Covid-19 has shown why medical records need to adapt". MedCity News. https://medcitynews.com/2020/07/physicians-deserve-better-software-covid-19-has-shown-why-medical-records-need-to-adapt/. Retrieved 18 August 2020. 
  7. ↑ Jason, C. (23 July 2020). "EHR Optimization, Health IT Projects Needed After COVID-19 Surge". EHR Intelligence. https://ehrintelligence.com/news/ehr-optimization-health-it-projects-needed-after-covid-19-surge. Retrieved 18 August 2020. 
  8. ↑ Reeves, J.J.; Pageler, N.M.; Wick, E.C. et al. (2021). "The Clinical Information Systems Response to the COVID-19 Pandemic". Yearbook of Medical Informatics 30 (1): 105–25. doi:10.1055/s-0041-1726513. PMC PMC8416224. PMID 34479384. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8416224. 
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