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

From LIMSWiki
Jump to navigationJump to search
Line 1: Line 1:
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?
Before we can talk about the details of COVID-19 reporting, we first must briefly discuss the science of epidemiology. The CDC defines epidemiology as "the method used to find the causes of health outcomes and diseases in populations."<ref name="CDCWhatIs16">{{cite web |url=https://www.cdc.gov/careerpaths/k12teacherroadmap/epidemiology.html |title=What is Epidemiology? |work=Teacher Roadmap |publisher=Centers for Disease Control and Prevention |date=17 June 2016 |accessdate=14 September 2021}}</ref> As we'll soon learn, finding those causes depends on quality data and reporting.


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" />
Epidemiology can broadly be split into two categories: descriptive epidemiology and analytical epidemiology. Descriptive epidemiology involves studies and other activities that deal with geographical comparisons and temporal trend descriptions of disease. As such, the collection and use of quality incidence data is vital to developing hypotheses.<ref name="NaitoUtil14">{{cite journal |title=Utilization and application of public health data in descriptive epidemiology |journal=Journal of Epidemiology |author=Naito, M. |volume=24 |issue=6 |pages=435–6 |year=2014 |doi=10.2188/jea.je20140182 |pmid=25327184 |pmc=PMC4213216}}</ref> Analytical epidemiology allows for the testing of those hypotheses using both experimental and observational studies, as well as control groups. Similarly, the collection and use of quality experimental and observational data is vital for proving or disproving hypotheses.<ref name="CDCPrinc12">{{cite book |url=https://www.cdc.gov/csels/dsepd/ss1978/SS1978.pdf |format=PDF |title=Principles of Epidemiology in Public Health Practice |author=Centers for Disease Control and Prevention |edition=3rd |publisher=Centers for Disease Control and Prevention |year=2012 |accessdate=11 April 2020}}</ref> In both cases, proper reporting of public health data is critical to the success of epidemiologists' response to outbreaks and pandemics, as well as the credibility of their research.<ref name="HamiltonUsing19">{{cite book |chapter=Chapter 5: Using Technologies for Data Collection and Management |title=The CDC Field Epidemiology Manual |author=Hamilton, J.J.; Hopkins, R.S. |editor=Rasmussen, S.A.; Goodman, R.A. |publisher=Oxford University Press |edition=4th |pages=71–104 |year=2019 |isbn=9780190933692}}</ref><ref name="vonElmTheStren07">{{cite journal |title=The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: Guidelines for reporting observational studies |journal=PLoS Medicine |author=von Elm, E.; Altman, D.G.; Egger, M. et al. |volume=4 |issue=10 |at=e296 |year=2007 |doi=10.1371/journal.pmed.0040296 |pmid=17941714 |pmc=PMC2020495}}</ref><ref name="Crear-PerryTheHid20">{{cite web |url=https://www.statnews.com/2020/11/05/rapid-covid-19-tests-hidden-public-health-hazard/ |title=The hidden public health hazard of rapid Covid-19 tests |author=Crear-Perry, J. |work=STAT |date=05 November 2020 |accessdate=21 November 2020}}</ref> This includes point-of-care and at-home testing results, which are at times more difficult to capture.<ref name="Crear-PerryTheHid20" />


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.
The proper reporting of COVID-19 case data is no exception. In the United States, the [[Centers for Disease Control and Prevention]] (CDC) has taken a standardized approach to collecting reports on individuals with "lab-confirmed and probable cases of COVID-19,"<ref name="CDCInstruct20">{{cite web |url=https://www.cdc.gov/coronavirus/2019-ncov/downloads/COVID-19-Persons-Under-Investigation-and-Case-Report-Form-Instructions.pdf |format=PDF |title=Instructions for Completing the Human Infection with 2019 Novel Coronavirus (COVID-19) Case Report Form |author=Centers for Disease Control and Prevention |publisher=Centers for Disease Control and Prevention |date=01 May 2020 |accessdate=21 November 2020}}</ref><ref name="CDCInformRepo20">{{cite web |url=https://www.cdc.gov/coronavirus/2019-ncov/php/reporting-pui.html |title=Information for Health Departments on Reporting Cases of COVID-19 |author=Centers for Disease Control and Prevention |work=Coronavirus Disease 2019 (COVID-19) |publisher=Centers for Disease Control and Prevention |date=05 May 2020 |accessdate=21 November 2020}}</ref> noting that as of April 21, 2021, all state, territorial, and tribal jurisdictions were onboard with electronic laboratory reporting to the CDC.<ref name="CDCCOVIDELR21">{{cite web |url=https://www.cdc.gov/coronavirus/2019-ncov/lab/electronic-reporting-map.html |title=COVID-19 Electronic Laboratory Reporting Implementation by State |author=Centers for Disease Control and Prevention |publisher=Centers for Disease Control and Prevention |date=20 April 2021 |accessdate=19 September 2021}}</ref> Their COVID-19 Surveillance Worksheet (formerly Case Report Form) is designed to collect a wide variety of information about a COVID-19 case, including patient demographics, epidemiological characteristics, exposure and contact history, clinical diagnosis, treatment procedures, and vaccination history. Currently, the CDC is asking healthcare providers and [[Laboratory|laboratories]] that are operating as testing sites to "report data for all diagnostic and screening testing completed, which includes molecular, antigen, and antibody testing, for each individual tested" on a daily basis, "within 24 hours of test completion."<ref name="CDCHowToRep20">{{cite web |url=https://www.cdc.gov/coronavirus/2019-ncov/lab/reporting-lab-data.html |title=How to Report COVID-19 Laboratory Data |author=Centers for Disease Control and Prevention |publisher=Centers for Disease Control and Prevention |date=26 January 2021 |accessdate=14 September 2021}}</ref> Local, state, tribal, and territorial public health departments are then asked to submit case reports etc. to the CDC. Electronic reporting using the CDC's system is preferred, but they have a protocol for those areas unable to submit electronically. Recognizing the disparate reporting mechanisms across various state health departments and the problems this causes, particularly during an epidemic, funding efforts are under way to assist the CDC—as well as state, local, and tribal governments—better report disease information through a modernized, centralized public health data management platform.<ref name="Crear-PerryTheHid20" /><ref name="CDCCentral20">{{cite web |url=https://sam.gov/opp/f0fc727c642640ed829d98fc880d4713/view |title=Centralized National Reporting Mechanism for COVID-19 Laboratory Tests Results and Other Reportable Conditions, United States |author=Centers for Disease Control and Prevention |work=SAM.gov |date=16 November 2020 |accessdate=14 September 2021}}</ref>
 
Elsewhere, Canada has similar reporting expectations to the U.S. CDC, with their own case report form and electronic data submission process through the Public Health Agency of Canada.<ref name="CanadaInterim20">{{cite web |url=https://www.canada.ca/en/public-health/services/diseases/2019-novel-coronavirus-infection/health-professionals/interim-guidance-surveillance-human-infection.html |title=National surveillance for Coronavirus disease (COVID-19) |author=Government of Canada |publisher=Government of Canada |date=19 March 2021 |accessdate=14 September 2021}}</ref> And in the European Union, member countries and the U.K. are asked to report through the Early Warning and Response System, with "additional enhanced surveillance ... established through The European Surveillance System - TESSy."<ref name="ECDCCaseDef20">{{cite web |url=https://www.ecdc.europa.eu/en/covid-19/surveillance |title=EU level surveillance of COVID19 |author=European Centre for Disease Prevention and Control |publisher=European Centre for Disease Prevention and Control |work=COVID-19 Portal |date=29 May 2020 |accessdate=21 November 2020}}</ref>


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

Revision as of 20:27, 3 February 2022

Before we can talk about the details of COVID-19 reporting, we first must briefly discuss the science of epidemiology. The CDC defines epidemiology as "the method used to find the causes of health outcomes and diseases in populations."[1] As we'll soon learn, finding those causes depends on quality data and reporting.

Epidemiology can broadly be split into two categories: descriptive epidemiology and analytical epidemiology. Descriptive epidemiology involves studies and other activities that deal with geographical comparisons and temporal trend descriptions of disease. As such, the collection and use of quality incidence data is vital to developing hypotheses.[2] Analytical epidemiology allows for the testing of those hypotheses using both experimental and observational studies, as well as control groups. Similarly, the collection and use of quality experimental and observational data is vital for proving or disproving hypotheses.[3] In both cases, proper reporting of public health data is critical to the success of epidemiologists' response to outbreaks and pandemics, as well as the credibility of their research.[4][5][6] This includes point-of-care and at-home testing results, which are at times more difficult to capture.[6]

The proper reporting of COVID-19 case data is no exception. In the United States, the Centers for Disease Control and Prevention (CDC) has taken a standardized approach to collecting reports on individuals with "lab-confirmed and probable cases of COVID-19,"[7][8] noting that as of April 21, 2021, all state, territorial, and tribal jurisdictions were onboard with electronic laboratory reporting to the CDC.[9] Their COVID-19 Surveillance Worksheet (formerly Case Report Form) is designed to collect a wide variety of information about a COVID-19 case, including patient demographics, epidemiological characteristics, exposure and contact history, clinical diagnosis, treatment procedures, and vaccination history. Currently, the CDC is asking healthcare providers and laboratories that are operating as testing sites to "report data for all diagnostic and screening testing completed, which includes molecular, antigen, and antibody testing, for each individual tested" on a daily basis, "within 24 hours of test completion."[10] Local, state, tribal, and territorial public health departments are then asked to submit case reports etc. to the CDC. Electronic reporting using the CDC's system is preferred, but they have a protocol for those areas unable to submit electronically. Recognizing the disparate reporting mechanisms across various state health departments and the problems this causes, particularly during an epidemic, funding efforts are under way to assist the CDC—as well as state, local, and tribal governments—better report disease information through a modernized, centralized public health data management platform.[6][11]

Elsewhere, Canada has similar reporting expectations to the U.S. CDC, with their own case report form and electronic data submission process through the Public Health Agency of Canada.[12] And in the European Union, member countries and the U.K. are asked to report through the Early Warning and Response System, with "additional enhanced surveillance ... established through The European Surveillance System - TESSy."[13]

References

  1. ↑ "What is Epidemiology?". Teacher Roadmap. Centers for Disease Control and Prevention. 17 June 2016. https://www.cdc.gov/careerpaths/k12teacherroadmap/epidemiology.html. Retrieved 14 September 2021. 
  2. ↑ Naito, M. (2014). "Utilization and application of public health data in descriptive epidemiology". Journal of Epidemiology 24 (6): 435–6. doi:10.2188/jea.je20140182. PMC PMC4213216. PMID 25327184. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4213216. 
  3. ↑ Centers for Disease Control and Prevention (2012) (PDF). Principles of Epidemiology in Public Health Practice (3rd ed.). Centers for Disease Control and Prevention. https://www.cdc.gov/csels/dsepd/ss1978/SS1978.pdf. Retrieved 11 April 2020. 
  4. ↑ Hamilton, J.J.; Hopkins, R.S. (2019). "Chapter 5: Using Technologies for Data Collection and Management". In Rasmussen, S.A.; Goodman, R.A.. The CDC Field Epidemiology Manual (4th ed.). Oxford University Press. pp. 71–104. ISBN 9780190933692. 
  5. ↑ von Elm, E.; Altman, D.G.; Egger, M. et al. (2007). "The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: Guidelines for reporting observational studies". PLoS Medicine 4 (10): e296. doi:10.1371/journal.pmed.0040296. PMC PMC2020495. PMID 17941714. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2020495. 
  6. ↑ 6.0 6.1 6.2 Crear-Perry, J. (5 November 2020). "The hidden public health hazard of rapid Covid-19 tests". STAT. https://www.statnews.com/2020/11/05/rapid-covid-19-tests-hidden-public-health-hazard/. Retrieved 21 November 2020. 
  7. ↑ Centers for Disease Control and Prevention (1 May 2020). "Instructions for Completing the Human Infection with 2019 Novel Coronavirus (COVID-19) Case Report Form" (PDF). Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/downloads/COVID-19-Persons-Under-Investigation-and-Case-Report-Form-Instructions.pdf. Retrieved 21 November 2020. 
  8. ↑ Centers for Disease Control and Prevention (5 May 2020). "Information for Health Departments on Reporting Cases of COVID-19". Coronavirus Disease 2019 (COVID-19). Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/php/reporting-pui.html. Retrieved 21 November 2020. 
  9. ↑ Centers for Disease Control and Prevention (20 April 2021). "COVID-19 Electronic Laboratory Reporting Implementation by State". Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/lab/electronic-reporting-map.html. Retrieved 19 September 2021. 
  10. ↑ Centers for Disease Control and Prevention (26 January 2021). "How to Report COVID-19 Laboratory Data". Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/lab/reporting-lab-data.html. Retrieved 14 September 2021. 
  11. ↑ Centers for Disease Control and Prevention (16 November 2020). "Centralized National Reporting Mechanism for COVID-19 Laboratory Tests Results and Other Reportable Conditions, United States". SAM.gov. https://sam.gov/opp/f0fc727c642640ed829d98fc880d4713/view. Retrieved 14 September 2021. 
  12. ↑ Government of Canada (19 March 2021). "National surveillance for Coronavirus disease (COVID-19)". Government of Canada. https://www.canada.ca/en/public-health/services/diseases/2019-novel-coronavirus-infection/health-professionals/interim-guidance-surveillance-human-infection.html. Retrieved 14 September 2021. 
  13. ↑ European Centre for Disease Prevention and Control (29 May 2020). "EU level surveillance of COVID19". COVID-19 Portal. European Centre for Disease Prevention and Control. https://www.ecdc.europa.eu/en/covid-19/surveillance. Retrieved 21 November 2020. 
Retrieved from "https://www.limswiki.org/index.php?title=User:Shawndouglas/sandbox/sublevel1&oldid=46079"