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| 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.
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| 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" />
| | ==''Introduction to Quality and Quality Management Systems''== |
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| | | text = This book should not be considered complete until this message box has been removed. This is a work in progress. |
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| | The goal of this short volume is to act as an introduction to the quality management system. It collects several articles related to quality, quality management, and associated systems. |
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| 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>
| | ;1. What is quality? |
| | :''Key terms'' |
| | :[[Quality (business)|Quality]] |
| | :[[Quality assurance]] |
| | :[[Quality control]] |
| | :''The rest'' |
| | :[[Data quality]] |
| | :[[Information quality]] |
| | :[[Nonconformity (quality)|Nonconformity]] |
| | :[[Service quality]] |
| | ;2. Processes and improvement |
| | :[[Business process]] |
| | :[[Process capability]] |
| | :[[Risk management]] |
| | :[[Workflow]] |
| | ;3. Mechanisms for quality |
| | :[[Acceptance testing]] |
| | :[[Conformance testing]] |
| | :[[Clinical quality management system]] |
| | :[[Continual improvement process]] |
| | :[[Corrective and preventive action]] |
| | :[[Good manufacturing practice]] |
| | :[[Malcolm Baldrige National Quality Improvement Act of 1987]] |
| | :[[Quality management]] |
| | :[[Quality management system]] |
| | :[[Total quality management]] |
| | ;4. Quality standards |
| | :[[ISO 9000]] |
| | :[[ISO 13485]] |
| | :[[ISO 14000|ISO 14001]] |
| | :[[ISO 15189]] |
| | :[[ISO/IEC 17025]] |
| | :[[ISO/TS 16949]] |
| | ;5. Quality in software |
| | :[[Software quality]] |
| | :[[Software quality assurance]] |
| | :[[Software quality management]] |
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| 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>
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| ==References==
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