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[[File:What is contact tracing COVID-19.png|right|280px]]Contact tracing is a public health process that involves the determination of who a patient had specific contact with while infectious, then informing, supporting, and maintaining contact with those effected individuals in order to reduce the spread of an infection.<ref name="CDCContact20">{{cite web |url=https://www.cdc.gov/coronavirus/2019-ncov/php/principles-contact-tracing.html |title=Case Investigation and Contact Tracing : Part of a Multipronged Approach to Fight the COVID-19 Pandemic |author=Centers for Disease Control and Prevention |publisher=Centers for Disease Control and Prevention |date=03 December 2020 |accessdate=17 September 2021}}</ref> The seeds of contact tracing may go as far back as late fifteenth and early sixteenth century efforts to control infection rates of syphilis among prostitutes in part of Europe.<ref name=RosenAHistory15">{{cite book |url=https://books.google.com/books?id=q5yeBgAAQBAJ&pg=PA46 |title=A History of Public Health |author=Rosen, G. |publisher=Johns Hopkins University Press |edition=Revised Expanded |pages=46–47 |year=2015 |isbn=9781421416021}}</ref> However, the practice was adopted more vigorously in the late nineteenth and early twentieth century in Great Britain for tracking cases of communicable diseases such as measles<ref name="MooneyIntrusive15">{{cite book |url=https://books.google.com/books?id=P1W3CgAAQBAJ&pg=PA93 |chapter=Chapter Four: Combustible Material - Classrooms, Contact Tracing, and Following-Up |title=Intrusive Interventions: Public Health, Domestic Space, and Infectious Disease Surveillance in England, 1840–1914 |author=Mooney, G. |publisher=University of Rochester Press |pages=93–120 |year=2015 |isbn=9781580465274}}</ref> and sexually transmitted diseases like syphilis and gonorrhea.<ref name="DavidsonSearching96">{{cite journal |title=‘Searching for Mary, Glasgow’: Contact Tracing for Sexually Transmitted Diseases in Twentieth-Century Scotland |journal=Social History of Medicine |author=Davidson, R. |volume=9 |issue=2 |pages=195–214 |year=1996 |doi=10.1093/shm/9.2.195}}</ref> Further inroads were made in the United States in the early 1930s with its efforts to reduce sexually transmitted diseases among U.S. troops.<ref name="Wigfield27Years72">{{cite journal |title=27 Years of Uninterrupted Contact Tracing: The 'Tyneside Scheme' |journal=British Journal of Venereal Diseases |author=Wigfield, A.S. |volume=48 |issue=1 |pages=37–50 |year=1972 |doi=10.1136/sti.48.1.37 |pmid=5067063 |pmc=PMC1048270}}</ref>
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Throughout it all, contract tracing has been predominately a manual effort. However, the technological age has brought with it both social promise and privacy questions in regards to the application of informatics to contact tracing. In the mid-2000s, the use of Wi-Fi and RFID technology in Singapore hospital settings "to provide an alternative to tedious and error-prone manual contact tracing" was being reported in academic literature.<ref name="LimDevelopment06">{{cite journal |url=https://www.apami.org/apami2006/papers/wlim(sg).pdf |format=PDF |title=Development of Medical Informatics in Singapore - Keeping Pace with Healthcare Challenges |journal=Proceedings from the 2006 Meeting of the Asia Pacific Association for Medical Informatics |author=Lim, W.T.L. |pages=1–4 |year=2006}}</ref> Since then, the use of informatics tools in contact tracing has increased, seeing practical application in combating [[severe acute respiratory syndrome]] (SARS)<ref name="ZhangBioPortal08">{{cite journal |title=BioPortal Infectious Disease Informatics research: Disease surveillance and situational awareness |journal=Proceedings of the 2008 International Conference on Digital Government Research |author=Zhang, Y.; Dang, Y.; Chen, Y.-D. et al. |pages=393–94 |year=2008 |doi=10.5555/1367832.1367909}}</ref>, Ebola<ref name="SchaferTheEpi16">{{cite journal |title=The Epi Info Viral Hemorrhagic Fever (VHF) Application: A Resource for Outbreak Data Management and Contact Tracing in the 2014–2016 West Africa Ebola Epidemic |journal=The Journal of Infectious Diseases |author=Schafer, I.J.; Knudsen, E.; McNamara, L.A. et al. |volume=214 |issue=Suppl. 3 |pages=S122–S136 |year=2016 |doi=10.1093/infdis/jiw272 |pmid=27587635}}</ref>, and tuberculosis.<ref name="HaEval16">{{cite journal |title=Evaluation of a Mobile Health Approach to Tuberculosis Contact Tracing in Botswana |journal=Journal of Health Communication |author=Ha, Y.P.; Tesfalul, M.A.; Littman-Quinn, R. et al. |volume=21 |issue=10 |pages=1115-21 |year=2016 |doi=10.1080/10810730.2016.1222035 |pmid=27668973 |pmc=PMC6238947}}</ref> As such, it should not be surprising that early in the COVID-19 pandemic, contract tracing was also being discussed within the context of both manual and digital tracing efforts.<ref name="CDCContact20" /><ref name="AHACDC20">{{cite web |url=https://www.aha.org/news/headline/2020-05-04-cdc-sets-preliminary-standards-digital-covid-19-contact-tracing-tools |title=CDC sets preliminary standards for digital COVID-19 contact tracing tools |author=American Hospital Association |publisher=American Hospital Association |date=04 May 2020 |accessdate=19 May 2020}}</ref><ref name="YanContact20">{{cite web |url=https://www.cnn.com/2020/04/27/health/contact-tracing-explainer-coronavirus/index.html |title=Contact tracing 101: How it works, who could get hired, and why it's so critical in fighting coronavirus now |author=Yan, H. |work=CNN Health |date=15 May 2020 |accessdate=19 May 2020}}</ref><ref name="FortinSoYou20">{{cite web |url=https://www.nytimes.com/2020/05/18/health/coronavirus-contact-tracing-jobs.html |title=So You Want to Be a Contact Tracer? |author=Fortin, J. |work=The New York Times |date=18 May 2020 |accessdate=19 May 2020}}</ref>
==''Introduction to Quality and Quality Management Systems''==
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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.


Contact tracing using digital tools, however, comes with both benefits and challenges.<ref name="WaltzHalting20">{{cite web |url=https://spectrum.ieee.org/halting-covid19-benefits-risks-digital-contact-tracing |title=Halting COVID-19: The Benefits and Risks of Digital Contact Tracing |author=Waltz, E. |work=IEEE Spectrum |date=25 March 2020 |accessdate=17 September 2021}}</ref><ref name="LewDigital20">{{cite web |url=https://www.decibio.com/insights/digital-contact-tracing-advantages-risks-post-covid-applications |title=‘Digital Contact Tracing’ — Advantages, Risks, & Post-COVID Applications |author=Lew, C.; Anderson, F. |work=DeciBio |date=14 April 2020 |accessdate=17 September 2021}}</ref> Digital contact tracing tools have the potential to make contract tracing quicker and more efficient than manual processes. People can forget who they may have been in close contact with, for example, but with digital tracing, past location data can be mined to provide a clearer picture. As a result, with more accurate data, local and state policy-making efforts can be more nimbly tailored to current needs, and the effectiveness of those efforts can be better monitored.<ref name="HaEval16" /><ref name="LimDevelopment06" /><ref name="WaltzHalting20" /><ref name="HuangHow20">{{cite web |url=https://hbr.org/2020/04/how-digital-contact-tracing-slowed-covid-19-in-east-asia |title=How Digital Contact Tracing Slowed Covid-19 in East Asia |work=Harvard Business Review |author=Huang, Y.; Sun, M.; Sui, Y. |date=15 April 2020 |accessdate=19 May 2020}}</ref> However, several challenges also exist, primarily with social and cultural perceptions of the technology's acceptability and the privacy concerns surrounding it.
;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]]


'''Social acceptability and trust around the world'''
<!--Place all category tags here-->
 
The social acceptability and trust put into contact tracing applications and the governments that use them is of significant concern. An April 2020 "blitz" survey of the Flemish Region of Belgium showed that only 51 percent of respondents had "no objection to a CORONA-app, under strict conditions."<ref name="KCDSSurvey20">{{cite web |url=https://data-en-maatschappij.ai/en/news/survey-corona-app |title=Survey: 51% has no objection to a corona-app, under strict conditions |author=Knowledge Centre Data & Society |publisher=Knowledge Centre Data & Society |date=08 April 2020 |accessdate=17 September 2021}}</ref> As legal researcher Domenico Orlando points out, many contact tracing applications like Italy's Immuni app, however, require at least 60 percent of the population to participate for it to be effective.<ref name="OrlandoTheEDPB20">{{cite web |url=https://www.law.kuleuven.be/citip/blog/the-edpb-guidelines-on-digital-tools-against-covid-19-a-brief-comment/ |title=The EDPB Guidelines on digital tools against Covid-19, a brief comment |work=KU Leuven Centre for IT & IP Law |date=12 May 2020 |accessdate=19 May 2020}}</ref> He adds that while whether or not "trust and social acceptance will follow is an unknown variable" when it comes to digital contact tracing, having a strong set of legal protections in place—such as those found with E.U. data protection law and the efforts of the European Data Protection Board (EDPB) to create data protection guidelines for digital surveillance tools<ref name="EDPBGuidelines20">{{cite web |url=https://edpb.europa.eu/our-work-tools/our-documents/guidelines/guidelines-042020-use-location-data-and-contact-tracing_en |title=Guidelines 04/2020 on the use of location data and contact tracing tools in the context of the COVID-19 outbreak |author=European Data Protection Board |publisher=European Data Protection Board |date=April 2020 |accessdate=17 September 2021}}</ref>—at least makes the technology more feasible.<ref name="OrlandoTheEDPB20" /> Political and cultural context also plays a role in social acceptance. Countries like South Korea and states like Taiwan—in comparison to mainland China—arguably have seen greater adoption of digital surveillance due to a more relaxed political context<ref name="NazeerDigital20">{{cite web |url=https://bylinetimes.com/2020/04/07/the-coronavirus-crisis-digital-surveillance-and-technological-totalitarianism/ |title=Digital Surveillance and 'Technological Totalitarianism' |author=Nazeer, T. |work=Byline Times |date=07 April 2020 |accessdate=15 May 2020}}</ref>, though attempts by the citizenry to be vigilantes who shame and discriminate others based on contact tracing data may work counter to that overall adoption rate.<ref name="WaltzHalting20" /> Recent past experiences with digitally tracing MERS and SARS outbreaks in both cases, however, have probably played an even greater role in the success of convincing those governments' citizenry to voluntarily participate.<ref name="HuangHow20" /> Similar adoption success can be seen in a Singapore poll that showed 70 percent of respondents were open to installing its government's voluntary TraceTogether app, which is based on the privacy-preserving protocol [[Journal:BlueTrace: A privacy-preserving protocol for community-driven contact tracing across borders|BlueTrace]].<ref name="HuangHow20" />
 
'''Challenges in the U.S.'''
 
In the United States, adopted use of contract tracing apps has been much more sporadic. Several cultural factors contribute. First and foremost, Americans' reluctance to answer calls from unknown numbers is continuing to increase. A First Orion 2019 ''Spam Call Trends and Projections Report'' found that more than 40 percent of calls received are spam calls, and 70 percent of Americans do not answer calls from an unknown number.<ref name="FOScam19">{{cite web |url=http://firstorion.com/wp-content/uploads/2019/07/First-Orion-Scam-Trends-Report_Summer-2019.pdf |format=PDF |title=Spam Call Trends and Projections Report - Summer 2019 |author=First Orion |publisher=First Orion |date=2019 |accessdate=21 November 2020}}</ref> A December 2019 TrueCaller report found that robocalls in the U.S. "increased from 7% [in 2018] to a staggering 35% – which means that more than every third spam call a user gets is a robocall."<ref name="KokTrue19">{{cite web |url=https://truecaller.blog/2019/12/03/truecaller-insights-top-20-countries-affected-by-spam-calls-sms-in-2019/ |title=TRUECALLER INSIGHTS: TOP 20 COUNTRIES AFFECTED BY SPAM CALLS & SMS IN 2019 |author=Kok, K.F. |work=TrueCaller |date=03 December 2019 |accessdate=21 November 2020}}</ref> This issues get complicated even further by lack of enforcement on "spoofing," the practice of making a phone number appear to originate locally, or from a specific business. Even if a call looks legitimate, it may actually not be.<ref name="FOScam19" /><ref name="JohnstonTheReal20">{{cite web |url=https://www.vice.com/en/article/935vvz/the-real-reason-contact-tracing-is-doomed-in-the-us-spam-calls |title=The Real Reason Contact Tracing Is Doomed in the US: Spam Calls |author=Johnston, C. |work=Vice |date=31 August 2020 |accessdate=21 November 2020}}</ref> As ''Vice'' writer Casey Johnston suggests, given spam and spoofing practices and the related lack of enforcement, "until the United States takes its scam and spam call problem seriously, we’re probably going to be in the contact-tracing dark ages for a very long time."<ref name="JohnstonTheReal20" />
 
Second, overall trust in the federal government to do what's best and resolve problems has some catching up to do. September 2020 polls by the Pew Research Center<ref name="PewAmericans20">{{cite web |url=https://www.pewresearch.org/politics/2020/09/14/americans-views-of-government-low-trust-but-some-positive-performance-ratings/ |title=Americans’ Views of Government: Low Trust, but Some Positive Performance Ratings |author=Pew Research Center |date=14 September 2020 |accessdate=21 November 2020}}</ref> and Gallup<ref name="SaadTrust20">{{cite web |url=https://news.gallup.com/poll/321119/trust-federal-government-competence-remains-low.aspx |title=Trust in Federal Government's Competence Remains Low |author=Saad, L. |work=Gallup |date=29 September 2020 |accessdate=21 November 2020}}</ref> showed faith in overall federal government near all-time lows. As Lydia Saad of Gallup concluded in her 2020 analysis: "As the country is engaged in critical efforts to combat the medical, economic and societal effects of the global coronavirus pandemic, Americans' trust in the federal government to handle domestic issues is near its lowest point in Gallup trends since 1972, as is their trust in the executive and legislative branches, public officials generally, and the American people themselves."<ref name="SaadTrust20" /> A few positive signs have shown, with overall public trust in government making a small uptick and "trust in the federal government to provide accurate information about COVID-19" rising with the January 2021 presidency change.<ref name="PewPublic21">{{cite web |url=https://www.pewresearch.org/politics/2021/05/17/public-trust-in-government-1958-2021/ |title=Public Trust in Government: 1958-2021 |author=Pew Research Center |date=17 May 2021 |accessdate=17 September 2021}}</ref><ref name="DurkeeTrust21">{{cite web |url=https://www.forbes.com/sites/alisondurkee/2021/01/26/trust-in-government-information-on-covid-19-surges-under-biden-poll-reports/ |archiveurl=https://web.archive.org/web/20210126160459/https://www.forbes.com/sites/alisondurkee/2021/01/26/trust-in-government-information-on-covid-19-surges-under-biden-poll-reports/ |title=Trust In Government Information On Covid Surges Under Biden, Poll Reports |author=Durkee, A. |work=Forbes |date=26 January 2021 |archivedate=26 January 2021 |accessdate=17 September 2021}}</ref> Yet as long as overall trust in the federal government remains low, it will continue to be difficult to roll out any significant contract tracing efforts across the nation.
 
Third, the ebbs and flows of case numbers—with surges in November 2020 and again in the summer of 2021 with the delta variant<ref name="StoneHow20">{{cite web |url=https://www.npr.org/sections/health-shots/2020/11/24/937178668/are-more-lockdowns-inevitable-or-can-other-measures-stop-the-surge |title=How Do We Stop This Surge? Here's What Experts Say Could Help |author=Stone, W. |work=NPR Shots |date=24 November 2021 |accessdate=17 September 2021}}</ref><ref name="DohenyAsDelta21">{{cite web |url=https://www.webmd.com/lung/news/20210831/delta-surge-contact-tracing |title=As Delta Surges, Contact Tracing Re-Takes COVID Center Stage |author=Doheny, K. |work=WebMD Health News |date=31 August 2021 |accessdate=17 September 2021}}</ref>—make the number of cases to track tough to overcome. This is often compounded by the time it takes to get results, often too long to stem the flow of new infections.<ref name="KhazanTheMost20">{{cite web |url=https://www.theatlantic.com/politics/archive/2020/08/contact-tracing-hr-6666-working-us/615637/ |title=The Most American COVID-19 Failure Yet |author=Khazan, O. |work=The Atlantic |date=31 August 2020}}</ref> A lack of a clear and organized national strategy for contract tracing, unlike the European Union<ref name="EUCorona20">{{cite web |url=https://ec.europa.eu/commission/presscorner/detail/en/QANDA_20_1905 |title=Coronavirus: EU interoperability gateway for contact tracing and warning apps – Questions and Answers |author=European Commission |publisher=European Union |date=19 October 2020 |accessdate=21 November 2020}}</ref>, punctuates the challenges of getting more people to use contact tracing apps.<ref name="UbertiDisjoint20">{{cite web |url=https://www.wsj.com/articles/disjointed-covid-19-apps-across-u-s-raise-questions-about-techs-role-11603272613 |title=Disjointed Covid-19 Apps Across U.S. Raise Questions About Tech’s Role |author=Uberti, D. |work=The Wall Street Journal |date=21 October 2020 |accessdate=21 November 2020}}</ref>
 
'''Privacy and other issues'''
 
The preservation of user privacy and sensitive identifying data are also vital considerations in digital tracing apps. The previously mentioned BlueTrace protocol and its open-source reference implementation OpenTrace strive to address most of those concerns when "logging Bluetooth encounters between participating devices to facilitate contact tracing, while protecting the users’ personal data and privacy." More specifically, it strives to limit collection of personally-identifiable information, locally store and lock down encounter history, prevent third-party tracking, and provide revocable consent to store and allow use of encounter data.<ref name="BayBlue20">{{cite journal |title=BlueTrace: A privacy-preserving protocol for community-driven contact tracing across borders |author=Bay, J.; Kek, J.; Tan, A. et al. |pages=1–9 |year=2020 |url=https://bluetrace.io/static/bluetrace_whitepaper-938063656596c104632def383eb33b3c.pdf}}</ref> Ultimately, these and other such solutions must ensure the anonymity of tracing data doesn't become compromised. Lew and Anderson also note that "[c]loud-based storage of anonymous identifier beacons may also threaten security, given that any centralized list of identifiers could theoretically be hacked and re-identified."<ref name="LewDigital20" /> As noted previously, re-identified data, let alone leaked anonymized data, could lead to shaming and discrimination against individuals identified as being infected.<ref name="WaltzHalting20" />
 
Privacy is not solely a concern of application developers, however. Government entities should also be held responsible for better ensuring how informatics solutions are created and used for epidemiological tracking. The European Union's EDPB and its contact tracing guidelines, adopted in April 2020, offer a compromise between the societal needs of contact tracing and the individual needs of privacy. The EDPB addresses the topics of location data sources and anonymized use, as well as the recommendations and functional requirements of applications employing those data sources, concluding "that one should not have to choose between an efficient response to the current crisis and the protection of our fundamental rights: we can achieve both."<ref name="EDPBGuidelines20" /> The U.S. CDC is less eloquent with its COVID-19 digital contact tracing guidelines, though they still stress the preference for secure data transfer mechanisms, open-source architecture, need-to-know-only access to data for public health authorities, and the ability for users to revoke data access consent at any time.<ref name="AHACDC20" />
 
Finally, most digital tracing solutions also suffer from a few additional downsides. Several researchers have expressed concerns about data accuracy and actionability issues in mobile devices that lead to false positives. These issues include<ref name="LewDigital20" /><ref name="BayBlue20" />:
 
* inaccurate inter-device distance detection
* inaccurate exposure detection in high-density buildings with multiple walls
* inability to track duration of exposure (i.e., seconds or hours)
* failures with the underlying technology itself, including BlueTooth or the operating system
 
'''The future'''
 
Despite these and other drawbacks, various governments around the world have found greater success at managing the COVID-19 pandemic with digital contact tracing. Huang ''et al.'' in the ''Harvard Business Review'' wonder if the successes reported in South Korea, Taiwan, and other parts of the East could be replicated in the United States and other Western democracies<ref name="HuangHow20" />:
 
<blockquote>Can Western democracies achieve the results seen in East Asia without emulating their means? Probably not. There is likely a fundamental conflict between these requirements and deeply entrenched Western liberal values, such as the expectation of privacy, consent, and the sanctity of individual rights ... At the time of publication, at least three local governments in the United States are considering adoption of a contact-tracing app developed in a project led by MIT, Reuters reports ... But for such technologies to be effective, compliance must be nearly universal. Without a government mandate in the U.S., it’s hard to imagine universal voluntary adoption of even a privacy-protecting tracing app.<br />&nbsp;<br />
Maybe Covid-19 is a sign of our future steady state. Different societies will make different choices about how to respond to the next pandemic. For Western democracies the time has come to either rethink our values around the tradeoff between personal privacy and public safety in a pandemic or to accelerate technology innovation and policy development that can preserve both.</blockquote>
 
==References==
{{Reflist|colwidth=30em}}
 
 
==Citation information for this chapter==
'''Chapter''': 4. Workflow and information management for COVID-19 (and other respiratory diseases)
 
'''Edition''': Fall 2021
 
'''Title''': ''COVID-19 Testing, Reporting, and Information Management in the Laboratory''
 
'''Author for citation''': Shawn E. Douglas
 
'''License for content''': [https://creativecommons.org/licenses/by-sa/4.0/ Creative Commons Attribution-ShareAlike 4.0 International]
 
'''Publication date''': September 2021

Latest revision as of 19:46, 9 February 2022

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Introduction to Quality and Quality Management Systems

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.

1. What is quality?
Key terms
Quality
Quality assurance
Quality control
The rest
Data quality
Information 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 14001
ISO 15189
ISO/IEC 17025
ISO/TS 16949
5. Quality in software
Software quality
Software quality assurance
Software quality management