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

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Instrument interfaces (discussed later in this chapter) are typically a non-trivial monetary investment for laboratories<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=25 April 2020}}</ref> as the developer has to take into account compliance requirements, the required analytical outcomes, and the instrument itself, as well as its available connections.<ref name="StraussConnect18">{{cite web |url=https://www.labmanager.com/laboratory-technology/connecting-lab-instruments-interface-strategies-depend-upon-compliance-requirements-2034 |title=Connecting Lab Instruments: Interface Strategies Depend Upon Compliance Requirements |author=Strauss, D. |work=Lab Manager |date=08 July 2018 |accessdate=30 April 2020}}</ref> Yet a laboratory informatics vendor with experience has likely already set up interfaces to the instruments used in testing COVID-19 and other respiratory illnesses. RT-PCR systems like Hologic's Panther Fusion<ref name="HologicPantherFusion20">{{cite web |url=https://www.hologic.com/coronavirus-test |title=Hologic’s Molecular Test for the Novel Coronavirus, SARS-CoV-2, Receives FDA Emergency Use Authorization |author=Hologic |publisher=Hologic, Inc |date=17 March 2020 |accessdate=30 April 2020}}</ref> and Abbot's RealTime m2000<ref name="AbbottRealTime20">{{cite web |url=https://www.molecular.abbott/us/en/products/infectious-disease/RealTime-SARS-CoV-2-Assay |title=Abbott RealTime SARS-CoV-2 Assay |author=Abbott |publisher=Abbott Laboratories |accessdate=30 April 2020}}</ref> represent a few of the systems being used to test for COVID-19 right now. Is the laboratory informatics system able to interface with these and other lab-based and point-of-care (POC) instruments you may require, at a reasonable cost? If so, also ensure the ease of assigning those instruments to specific tests or samples in the system. You should also be able to document well numbers for the analysis, as well as later view which samples are associated with a particular instrument. (In some cases, an instrument may be solely allocated to one specific test type.)
Already mentioned was the process of results approval and the importance of being able to clearly view those results both within and out of test limits. Of course, this information has to be reported for internal and external purposes. Internally, the laboratory or healthcare entity using the informatics system will want to understand their test volume and associated details. If there's any chance the information can be used internally for medical research insights, [[data mining]] tools may also be a welcome addition to the system.<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> Additionally, a laboratory results report for SARS-CoV-2 infection will also have to be distributed to the local or state health department along with a case report. Externally, ordering physicians and other external customers—including patients—will require clear and timely results in the form of a report. How does the laboratory informatics solution help with these and other reporting requirements? Can it assist with any external electronic reporting requirements (such as those with the Centers for Medicare & Medicaid Services) you may have?
 
The system's reporting tools should be configurable to the lab's needs. The reporting itself should provide fields for the addition of comments and consultation notes from the lab and the physician, as the stakeholders need to give clinical and diagnostic guidance based on not only the results but also critical comments. In some cases, a lab or healthcare system may require the addition of comments at different stages of reporting. Perhaps an initial results report is created by the lab and sent to the provider via the provider portal, but a pathologist needs to review the report and add additional commentary concerning future treatment or concerns about the test results. This requires the system be flexible enough to allow additional steps before a report is finalized. Whether or not the system is capable of automating the reporting process may also be worthy of consideration.<ref name="WeemaesLab20" />
 
Finally, some solutions may include a disease- or test-specific dashboard that can show all samples related to a test, any positives, any negatives, pending results, tests per day, etc. Having this information available in one location can help facilitate reporting to government entities (e.g., reporting statistics to FEMA during emergencies<ref name="FEMACorona20">{{cite web |url=https://www.fema.gov/press-release/20210318/coronavirus-covid-19-pandemic-hhs-letter-hospital-administrators |title=Coronavirus (COVID-19) Pandemic: HHS Letter to Hospital Administrators |author=Azar, A.M. |publisher=FEMA |date=10 April 2020 |accessdate=13 September 2021}}</ref> While not strictly necessary, ensure the solution can fulfill your needs with displaying real-time and near-time information to better support rapid decision making.


==References==
==References==
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Revision as of 20:26, 3 February 2022

Already mentioned was the process of results approval and the importance of being able to clearly view those results both within and out of test limits. Of course, this information has to be reported for internal and external purposes. Internally, the laboratory or healthcare entity using the informatics system will want to understand their test volume and associated details. If there's any chance the information can be used internally for medical research insights, data mining tools may also be a welcome addition to the system.[1] Additionally, a laboratory results report for SARS-CoV-2 infection will also have to be distributed to the local or state health department along with a case report. Externally, ordering physicians and other external customers—including patients—will require clear and timely results in the form of a report. How does the laboratory informatics solution help with these and other reporting requirements? Can it assist with any external electronic reporting requirements (such as those with the Centers for Medicare & Medicaid Services) you may have?

The system's reporting tools should be configurable to the lab's needs. The reporting itself should provide fields for the addition of comments and consultation notes from the lab and the physician, as the stakeholders need to give clinical and diagnostic guidance based on not only the results but also critical comments. In some cases, a lab or healthcare system may require the addition of comments at different stages of reporting. Perhaps an initial results report is created by the lab and sent to the provider via the provider portal, but a pathologist needs to review the report and add additional commentary concerning future treatment or concerns about the test results. This requires the system be flexible enough to allow additional steps before a report is finalized. Whether or not the system is capable of automating the reporting process may also be worthy of consideration.[1]

Finally, some solutions may include a disease- or test-specific dashboard that can show all samples related to a test, any positives, any negatives, pending results, tests per day, etc. Having this information available in one location can help facilitate reporting to government entities (e.g., reporting statistics to FEMA during emergencies[2] While not strictly necessary, ensure the solution can fulfill your needs with displaying real-time and near-time information to better support rapid decision making.

References