Using Syndromic Surveillance Alert Protocols for  Epidemiologic Response in Georgia

ObjectiveDescribe how the Georgia Department of Public Health (DPH) usessyndromic surveillance to initiate review by District Epidemiologists(DEs) to events that may warrant a public health response (1).IntroductionDPH uses its State Electronic Notifiable Disease SurveillanceSystem (SendSS) Syndromic Surveillance (SS) Module to collect,analyze and display results of emergency department patient chiefcomplaint data from hospitals throughout Georgia.MethodsDPH prepares a daily SS report, based upon the analysis ofdaily visits to 112 Emergency Department (EDs). The visits areclassified in 33 syndromes. Queries of chief complaint and dischargediagnosis are done using the internal query capability of SendSS-SSand programming in SAS/BASE. Charting of the absolute countsor percentage of ED visits by syndromes is done using the internalcharting capability of SendSS-SS. A daily SS report includes thefollowing sections:Statewide Emergency Department Visitsby Priority Syndromes(Bioterrorism, BloodyRespiratory,FeverRespiratory, FeverChest, FeverFluAdmit, FeverFluDeaths,VeryIll, andPoxRashFever, Botulism, Poison, BloodyDiarrhea,BloodyVomit, FeverGI, ILI, FeverFlu, RashFever, Diarrhea,Vomit).Statewide Flag Analysis: Is intended to detect statewideflags, by using theChartscapability in SendSS SS.Possible caseswith presumptive diagnosis of potentially notifiable diseases: Isintended to provide early-warning to the DEs of possible cases thatare reportable to public health immediately or within 7 days usingqueries in the Chief Complaint and Preliminary Diagnosis fields ofSendSS-SS.Possible clusters of illness: Since any cluster of illnessmust be reported immediately to DPH, this analysis is aimed atquerying and identifying possible clusters of patients with similarsymptoms (2).Possible travel-related illness: Is intended to identifypatients with symptoms and recent travel history.Other events ofinterest: Exposures to ill patients in institutional settings (e.g. chiefcomplaint indicates that other children in the daycare have similarsymptoms).Trend Analysis: Weekly analysis of seasonality andtrends of 14 syndromes. Finally, specific events are notified to andreviewed by the 18 DEs, who follow up by contacting the InfectionPreventionists of the hospitals to identify the patients using medicalrecords or other hospital-specific identification numbers and followup on the laboratory test results.ResultsSince 05/15/2016, 12 travel-related illnesses, 29 vaccine-preventable diseases, 14 clusters, and 3 chemical exposures havebeen notified to DEs. For instance, a cluster of chickenpox in childrenwas identified after the DE contacted the Infection Preventionist ofa hospital, who provided the DE with the laboratory results and thephysician notes about the symptoms of the patients. These actionshave resulted in earlier awareness of single cases or cluster of illness,prompt reporting of notifiable diseases, and successful interactionbetween DEs and health care providers. In addition, SS continues totrack the onset, peak, and decline of seasonal illnesses.ConclusionsThe implementation of SS in the State of Georgia is helping withthe timely detection and early responses to disease events and couldprove useful in reducing the disease burden caused by a bioterroristattack.

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Use of Emergency Department Data to Monitor and Respond to an Increase in Opioid Overdoses in New Hampshire, 2011-2015

Public Health Reports ◽

10.1177/0033354917707934 ◽

2017 ◽

Vol 132 (1_suppl) ◽

pp. 73S-79S ◽

Cited By ~ 8

Author(s):

Elizabeth R. Daly ◽

Kenneth Dufault ◽

David J. Swenson ◽

Paul Lakevicius ◽

Erin Metcalf ◽

...

Keyword(s):

Public Health ◽

Emergency Department ◽

New Hampshire ◽

Syndromic Surveillance ◽

Situational Awareness ◽

The United States ◽

Chief Complaint ◽

Public Health Response ◽

Syndromic Surveillance System ◽

Icd Codes

Objectives: Opioid-related overdoses and deaths in New Hampshire have increased substantially in recent years, similar to increases observed across the United States. We queried emergency department (ED) data in New Hampshire to monitor opioid-related ED encounters as part of the public health response to this health problem. Methods: We obtained data on opioid-related ED encounters for the period January 1, 2011, through December 31, 2015, from New Hampshire’s syndromic surveillance ED data system by querying for (1) chief complaint text related to the words “fentanyl,” “heroin,” “opiate,” and “opioid” and (2) opioid-related International Classification of Diseases ( ICD) codes. We then analyzed the data to calculate frequencies of opioid-related ED encounters by age, sex, residence, chief complaint text values, and ICD codes. Results: Opioid-related ED encounters increased by 70% during the study period, from 3300 in 2011 to 5603 in 2015; the largest increases occurred in adults aged 18-29 and in males. Of 20 994 total opioid-related ED visits, we identified 18 554 (88%) using ICD code alone, 690 (3%) using chief complaint text alone, and 1750 (8%) using both chief complaint text and ICD code. For those encounters identified by ICD code only, the corresponding chief complaint text included varied and nonspecific words, with the most common being “pain” (n = 3335, 18%), “overdose” (n = 1555, 8%), “suicidal” (n = 816, 4%), “drug” (n = 803, 4%), and “detox” (n = 750, 4%). Heroin-specific encounters increased by 827%, from 4% of opioid-related encounters in 2011 to 24% of encounters in 2015. Conclusions: Opioid-related ED encounters in New Hampshire increased substantially from 2011 to 2015. Data from New Hampshire’s ED syndromic surveillance system provided timely situational awareness to public health partners to support the overall response to the opioid epidemic.

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Immigrant Communities and COVID-19: Strengthening the Public Health Response

American Journal of Public Health ◽

10.2105/ajph.2021.306433 ◽

2021 ◽

Vol 111 (S3) ◽

pp. S224-S231

Author(s):

Lan N. Đoàn ◽

Stella K. Chong ◽

Supriya Misra ◽

Simona C. Kwon ◽

Stella S. Yi

Keyword(s):

Public Health ◽

Health Care ◽

Health Care Providers ◽

Low Income ◽

Immigrant Communities ◽

Care Providers ◽

Public Health Response ◽

The Public ◽

Public Health Infrastructure ◽

Health Infrastructure

The COVID-19 pandemic has exposed the many broken fragments of US health care and social service systems, reinforcing extant health and socioeconomic inequities faced by structurally marginalized immigrant communities. Throughout the pandemic, even during the most critical period of rising cases in different epicenters, immigrants continued to work in high-risk-exposure environments while simultaneously having less access to health care and economic relief and facing discrimination. We describe systemic factors that have adversely affected low-income immigrants, including limiting their work opportunities to essential jobs, living in substandard housing conditions that do not allow for social distancing or space to safely isolate from others in the household, and policies that discourage access to public resources that are available to them or that make resources completely inaccessible. We demonstrate that the current public health infrastructure has not improved health care access or linkages to necessary services, treatments, or culturally competent health care providers, and we provide suggestions for how the Public Health 3.0 framework could advance this. We recommend the following strategies to improve the Public Health 3.0 public health infrastructure and mitigate widening disparities: (1) address the social determinants of health, (2) broaden engagement with stakeholders across multiple sectors, and (3) develop appropriate tools and technologies. (Am J Public Health. 2021;111(S3):S224–S231. https://doi.org/10.2105/AJPH.2021.306433 )

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Nurses' Attitudes towards Drug-Seekers in the Emergency Room

10.28971/532013gm70 ◽

2013 ◽

Author(s):

Megan Gernt

Keyword(s):

Emergency Department ◽

Health Care Providers ◽

Policy Development ◽

Survey Design ◽

Educational Programs ◽

Chief Complaint ◽

Care Providers ◽

Drug Seeking ◽

Emergency Department Patients ◽

Descriptive Survey

<p>Emergency department patients often present with a chief complaint of pain. There is a unique population of patients who present with this chief complaint in an effort to obtain narcotics for non-medical use. This population is often referred to as drug-seekers and there is little information available to define what exactly nurses mean when they use this term. This study utilized a descriptive survey design to gain a better understanding of nurses’ use of the term drug-seeker. Respondents agreed on a variety of behaviors that lead them to identify patients as drug-seeking and expressed a frustration with this population of patients. Many respondents identified a lack of clear policies and education around this population as a challenge. By understanding how nurses use the term drug-seeking, and developing an understanding what some of their concerns are regarding this population, the opportunity presents itself for the development of educational programs in order to train health care providers to best care for this challenging population. Additionally, the opportunity exists for policy development and implementation around this population in order to provide safe, comprehensive, and satisfactory care<strong>.</strong></p>

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Health, housing, and ‘direct threats’ during a pandemic

Journal of Law and the Biosciences ◽

10.1093/jlb/lsaa022 ◽

2020 ◽

Vol 7 (1) ◽

Author(s):

Jennifer K Wagner

Keyword(s):

Public Health ◽

Health Care Providers ◽

Care Providers ◽

Human Right ◽

Public Health Response ◽

Primary Responsibility ◽

Health Response ◽

Force Majeure ◽

The Government ◽

Direct Threat

Abstract The COVID-19 pandemic brought into stark relief the intimate nexus between health and housing. This extraordinary infectious disease outbreak combined with the astounding lack of a clear, coordinated, prompt, and effective public health response in the U.S. created conditions and introduced practical challenges that left many disoriented-not only health care providers but also housing providers. Innumerable issues are worth examination, such as implications of moratoria on evictions and foreclosures, force majeure contract clauses, insurability of pandemic-related damages and disruptions, holdover tenancies and delayed occupancies, and possible abatement of rent or homeowner/condominium association dues in light of closed common facilities (such as fitness areas) or reduced benefits to be enjoyed with residential property; however, this article focuses on fair housing law and the ``direct threat'' exemption; finds it unlikely that COVID-19 is a disability, likely that the ``direct threat'' defense is available, and both determinations to be case-specific inquiries dependent upon rapidly-changing scientific understanding of this disease. By highlighting adequate housing as a human right for which the government has primary responsibility for ensuring its achievement, this article underscores the importance of finding a holistic solution to public health and housing problems before the next public health emergency arises.

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Tracking drug-related overdoses at the local level: Using Syndromic Surveillance in the CO-NCR

Online Journal of Public Health Informatics ◽

10.5210/ojphi.v10i1.8977 ◽

2018 ◽

Vol 10 (1) ◽

Author(s):

Emery Shekiro ◽

Lily Sussman ◽

Talia Brown

Keyword(s):

Public Health ◽

Emergency Department ◽

Real Time ◽

Drug Overdose ◽

Syndromic Surveillance ◽

Case Definition ◽

Chief Complaint ◽

Discharge Diagnosis ◽

Diagnosis Codes ◽

Drug Overdoses

Objective: In order to better describe local drug-related overdoses, we developed a novel syndromic case definition using discharge diagnosis codes from emergency department data in the Colorado North Central Region (CO-NCR). Secondarily, we used free text fields to understand the use of unspecified diagnosis fields.Introduction: The United States is in the midst of a drug crisis; drug-related overdoses are the leading cause of unintentional death in the country. In Colorado the rate of fatal drug overdose increased 68% from 2002-2014 (9.7 deaths per 100,000 to 16.3 per 100,000, respectively)1, and non-fatal overdose also increased during this time period (23% increase in emergency department visits since 2011)2. The CDC’s National Syndromic Surveillance Program (NSSP) provides near-real time monitoring of emergency department (ED) events across the country, with information uploaded daily on patient demographics, chief complaint for visit, diagnosis codes, triage notes, and more. Colorado North Central Region (CO-NCR) receives data for 4 local public health agencies from 25 hospitals across Adams, Arapahoe, Boulder, Denver, Douglas, and Jefferson Counties.Access to local syndromic data in near-real time provides valuable information for local public health program planning, policy, and evaluation efforts. However, use of these data also comes with many challenges. For example, we learned from key informant interviews with ED staff in Boulder and Denver counties, about concern with the accuracy and specificity of drug-related diagnosis codes, specifically for opioid-related overdoses.Methods: Boulder County Public Health (BCPH) and Denver Public Health (DPH) developed a query in Early Notification of Community Based Epidemics (ESSENCE) using ICD-10-CM codes to identify cases of drug-related overdose [T36-T51] from October 2016 to September 2017. The Case definition included unintentional, self-harm, assault and undetermined poisonings, but did not include cases coded as adverse effects or underdosing of medication. Cases identified in the query were stratified by demographic factors (i.e., gender and age) and substance used in poisoning. The first diagnosis code in the file was considered the primary diagnosis. Chief complaint and triage note fields were examined to further describe unspecified cases and to describe how patients present to emergency departments in the CO-NCR. We also explored whether detection of drug overdose visits captured by discharge diagnosis data varied by patient sex, age, or county.Results: The query identified 2,366 drug-related overdoses in the CO-NCR. The prevalence of drug overdoses differed across age groups. The detection of drug overdoses was highest among our youth and young adult populations; 16 to 20 year olds (16.0%), 21-25 year olds (11.4%), 26-30 year olds (11.4%). Females comprised 56.1% of probable general drug overdoses. The majority of primary diagnoses (31.0%) included poisonings related to diuretics and other unspecified drugs (T50), narcotics (T40) (12.6%), or non-opioid analgesics (T39) (7.8%). For some cases with unspecified drug overdose codes there was additional information about drugs used and narcan administration found in the triage notes and chief complaint fields.Conclusions: Syndromic surveillance offers the opportunity to capture drug-related overdose data in near-real time. We found variation in drug-related overdose by demographic groups. Unspecified drug overdose codes are extremely common, which likely negatively impacts the quality of drug-specific surveillance. Leveraging chief complaint and triage notes could improve our understanding of factors involved in drug-related overdose with limitations in discharge diagnosis. Chart reviews and access to more fields from the ED electronic health record could improve local drug surveillance.

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Detection of SARS-CoV-2 RNA and Antibodies in Diverse Samples: Protocol to Validate the Sufficiency of Provider-Observed, Home-Collected Blood, Saliva, and Oropharyngeal Samples

JMIR Public Health and Surveillance ◽

10.2196/19054 ◽

2020 ◽

Vol 6 (2) ◽

pp. e19054 ◽

Cited By ~ 20

Author(s):

Patrick Sean Sullivan ◽

Charles Sailey ◽

Jodie Lynn Guest ◽

Jeannette Guarner ◽

Colleen Kelley ◽

...

Keyword(s):

Public Health ◽

Health Care ◽

Health Care Providers ◽

Clinical Decision Making ◽

The United States ◽

Alternative Methods ◽

Nasopharyngeal Swab ◽

Care Providers ◽

Public Health Response ◽

Specimen Collection

Background The response in the United States to the coronavirus disease (COVID-19) pandemic has been hampered by a lack of aggressive testing for the infection. Testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cornerstone of an effective public health response. However, efforts to test have been hampered by limited reagents, limitations in the availability of swabs used for the collection of nasopharyngeal swab (NPS) specimens, limitations in personal protective equipment (PPE) for health care providers collecting the NPS specimens, and limitations in viral transport media for transporting the specimens. Therefore, more flexible options for screening for SARS-CoV-2 RNA and serologic responses are critical to inform clinical and public health responses. Objective We aim to document the ability of patients to self-collect sufficient specimens for SARS-CoV-2 viral detection and serology. Methods Patient self-collection of samples will be done with observation by a health care provider during a telemedicine session. Participants will be mailed a specimen collection kit, engage in a telehealth session with a provider through a HIPPA (Health Insurance Portability and Accountability Act of 1996)-compliant video meeting, and collect specimens while being observed by the provider. Providers will record whether they are confident in the suitability of the specimen for laboratory testing that would inform clinical decision making. We will objectively assess the sufficiency of biological material in the mailed-in specimens. Results The protocol was approved by the Emory University Institutional Review Board (IRB) on March 30, 2020 (Protocol number 371). To date, we have enrolled 159 participants. Conclusions Defining a conceptual framework for assessing the sufficiency of patient-collected samples for the detection of SARS-CoV-2 RNA and serologic responses to infection is critical for facilitating public health responses and providing PPE-sparing options to increase testing. Validation of alternative methods of specimen collection should include objective measures of the sufficiency of specimens for testing. A strong evidence base for diversifying testing modalities will improve tools to guide public health responses to the COVID-19 pandemic.

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Epidemiological Investigation, Monitoring and Surveillance; Strategies in Public Health Sustenance

Asian Journal of Advanced Research and Reports ◽

10.9734/ajarr/2019/v5i230130 ◽

2019 ◽

pp. 1-9

Author(s):

Ekwem Ikechukwu ◽

Ilochi Ogadinma ◽

Arthur Nwafor Chuemere

Keyword(s):

Public Health ◽

Health Care Providers ◽

Personal Information ◽

Significant Degree ◽

Human Interaction ◽

Contact Tracing ◽

Public Health Authority ◽

Surveillance Systems ◽

Care Providers ◽

Notifiable Diseases

Monitoring, surveillance and investigation of health threats are vital capabilities for an effective health system. The International Health Regulations require countries to maintain an integrated, national system for public health surveillance and response and set out the core capabilities that countries are required to achieve. Public health laws typically establish a list of “notifiable diseases” and other conditions that health care providers, hospitals and/or laboratories are required to report to the relevant local or national public health authority. Notifiable diseases generally include infectious diseases that can quickly spread throughout communities and regions via water, food, contact with animals, mosquitoes, airborne droplets or through sexual contact and other forms of human interaction. Rare and new events may not be included in regular, clinical and laboratory-based surveillance systems. Also, outbreaks of serious or contagious diseases require immediate investigation so that appropriate public health measures including isolation and contact tracing can be implemented. A significant degree of stigma may be attached to some diseases. Notifiable disease legislation should require the protection of personal information, and clearly define any exceptions. Concerns about discrimination and breach of privacy may be addressed by requiring certain diseases to be reported on an anonymous or de-identified basis.

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Tracking suspected heroin overdoses in CDC's National Syndromic Surveillance Program

Online Journal of Public Health Informatics ◽

10.5210/ojphi.v10i1.8982 ◽

2018 ◽

Vol 10 (1) ◽

Author(s):

Alana M. Vivolo-Kantor ◽

R. Matthew Gladden ◽

Aaron Kite-Powell ◽

Michael Coletta ◽

Grant Baldwin

Keyword(s):

Public Health ◽

United States ◽

Emergency Department ◽

Drug Overdose ◽

Syndromic Surveillance ◽

Case Definition ◽

Chief Complaint ◽

Heroin Overdose ◽

Ed Visits ◽

Overdose Deaths

ObjectiveThis paper analyzes emergency department syndromic data in the Centers for Disease Control and Prevention’s (CDC) National Syndromic Surveillance Program’s (NSSP) BioSense Platform to understand trends in suspected heroin overdose.IntroductionOverdose deaths involving opioids (i.e., opioid pain relievers and illicit opioids such as heroin) accounted for at least 63% (N = 33,091) of overdose deaths in 2015. Overdose deaths related to illicit opioids, heroin and illicitly-manufactured fentanyl, have rapidly increased since 2010. For instance, heroin overdose deaths quadrupled from 3,036 in 2010 to 12,989 in 2015. Unfortunately, timely response to emerging trends is inhibited by time lags for national data on both overdose mortality via vital statistics (8-12 months) and morbidity via hospital discharge data (over 2 years). Emergency department (ED) syndromic data can be leveraged to respond more quickly to emerging drug overdose trends as well as identify drug overdose outbreaks. CDC’s NSSP BioSense Platform collects near real-time ED data on approximately two-thirds of ED visits in the US. NSSP’s data analysis and visualization tool, Electronic Surveillance System for the Notification of Community-based Epidemics (ESSENCE), allows for tailored syndrome queries and can monitor ED visits related to heroin overdose at the local, state, regional, and national levels quicker than hospital discharge data.MethodsWe analyzed ED syndromic data using ESSENCE to detect monthly and annual trends in suspected unintentional or undetermined heroin overdose by sex and region for those 11 years and older. An ED visit was categorized as a suspected heroin overdose if it met several criteria, including heroin overdose ICD-9-CM and ICD-10-CM codes (i.e., 965.01 and E850.0; T40.1X1A, T40.1X4A) and chief complaint text associated with a heroin overdose (e.g., “heroin overdose”). Using computer code developed specifically for ESSENCE based on our case definition, we queried data from 9 of the 10 HHS regions from July 2016-July 2017. One region was excluded due to large changes in data submitted during the time period. We conducted trend analyses using the proportion of suspected heroin overdoses by total ED visits for a given month with all sexes and regions combined and then stratified by sex and region. To determine significant linear changes in monthly and annual trends, we used the National Cancer Institute’s Joinpoint Regression Program.ResultsFrom July 2016-July 2017, over 72 million total ED visits were captured from all sites and jurisdictions submitting data to NSSP. After applying our case definition to these records, 53,786 visits were from a suspected heroin overdose, which accounted for approximately 7.5 heroin overdose visits per 10,000 total ED visits during that timeframe. The rate of suspected heroin overdose visits to total ED visits was highest in June 2017 (8.7 per 10,000) and lowest in August 2016 (6.6 per 10,000 visits). Males accounted for a larger rates of visits over all months (range = 10.7 to 14.2 per 10,000 visits) than females (range = 3.8 to 4.7 per 10,000 visits). Overall, compared to July 2016, suspected heroin overdose ED visits from July 2017 were significantly higher for all sexes and US regions combined (β = .010, p = .036). Significant increases were also demonstrated over time for males (β = .009, p = .044) and the Northeast (β = .012, p = .025). No other significant increases or decreases were detected by demographics or on a monthly basis.ConclusionsEmergency department visits related to heroin overdose increased significantly from July 2016 to July 2017, with significant increases in the Northeast and among males. Urgent public health action is needed reduce heroin overdoses including increasing the availability of naloxone (an antidote for opioid overdose), linking people at high risk for heroin overdose to medication-assisted treatment, and reducing misuse of opioids by implementing safer opioid prescribing practices. Despite these findings, there are several limitations of these data: not all states sharing data have full participation thus limiting the representativeness of the data; not all ED visits are shared with NSSP; and our case definition may under-identify (e.g., visits missing discharge diagnosis codes and lacking specificity in chief complaint text) or over-identify (e.g., reliance on hospital staff impression and not drug test results) heroin overdose visits. Nonetheless, ED syndromic surveillance data can provide timely insight into emerging regional and national heroin overdose trends.ReferencesWarner M, Chen LH, Makuc DM, Anderson RN, Minino AM. Drug poisoning deaths in the United States, 1980-2008. NCHS Data Brief 2011(81):1-8.Rudd RA, Seth P, David F, Scholl L. Increases in Drug and Opioid-Involved Overdose Deaths - United States, 2010-2015. MMWR Morb Mortal Wkly Rep 2016;65(5051):1445-1452.Spencer MRA, F. Timeliness of Death Certificate Data for Mortality Surveillance and Provisional Estimates. National Center for Health Statistics 2017.Richards CL, Iademarco MF, Atkinson D, Pinner RW, Yoon P, Mac Kenzie WR, et al. Advances in Public Health Surveillance and Information Dissemination at the Centers for Disease Control and Prevention. Public Health Rep 2017;132(4):403-410.

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Searching for MERS and Novel Flu with Limited Resources

Online Journal of Public Health Informatics ◽

10.5210/ojphi.v6i1.5163 ◽

2014 ◽

Vol 6 (1) ◽

Author(s):

Alan Siniscalchi ◽

Charlie Ishikawa

Keyword(s):

Public Health ◽

Health Care Providers ◽

Burden Of Illness ◽

Recent Experience ◽

Surveillance Systems ◽

Care Providers ◽

Emerging Viruses ◽

Public Health Response ◽

Public Health Agencies ◽

Health Agencies

This project reviewed approaches used by public health agencies for alerting health care providers and enhancing surveillance systems to identify the presence of novel respiratory disease and to characterize their recent experience in searching for globally emerging viruses. Public health agencies continue to endeavor to develop and maintain cost-effective disease surveillance systems to better understand the burden of illness, especially newly emerging disease, within their jurisdiction. The importance of maintaining sufficient infrastructure and the trained personnel needed to operate these surveillance systems for optimal disease detection and public health response readiness cannot be understated.

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Detection of SARS-CoV-2 RNA and Antibodies in Diverse Samples: Protocol to Validate the Sufficiency of Provider-Observed, Home-Collected Blood, Saliva, and Oropharyngeal Samples (Preprint)

10.2196/preprints.19054 ◽

2020 ◽

Cited By ~ 3

Author(s):

Patrick Sean Sullivan ◽

Charles Sailey ◽

Jodie Lynn Guest ◽

Jeannette Guarner ◽

Colleen Kelley ◽

...

Keyword(s):

Public Health ◽

Health Care ◽

Health Care Providers ◽

Clinical Decision Making ◽

The United States ◽

Alternative Methods ◽

Nasopharyngeal Swab ◽

Care Providers ◽

Public Health Response ◽

Specimen Collection

BACKGROUND The response in the United States to the coronavirus disease (COVID-19) pandemic has been hampered by a lack of aggressive testing for the infection. Testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cornerstone of an effective public health response. However, efforts to test have been hampered by limited reagents, limitations in the availability of swabs used for the collection of nasopharyngeal swab (NPS) specimens, limitations in personal protective equipment (PPE) for health care providers collecting the NPS specimens, and limitations in viral transport media for transporting the specimens. Therefore, more flexible options for screening for SARS-CoV-2 RNA and serologic responses are critical to inform clinical and public health responses. OBJECTIVE We aim to document the ability of patients to self-collect sufficient specimens for SARS-CoV-2 viral detection and serology. METHODS Patient self-collection of samples will be done with observation by a health care provider during a telemedicine session. Participants will be mailed a specimen collection kit, engage in a telehealth session with a provider through a HIPPA (Health Insurance Portability and Accountability Act of 1996)-compliant video meeting, and collect specimens while being observed by the provider. Providers will record whether they are confident in the suitability of the specimen for laboratory testing that would inform clinical decision making. We will objectively assess the sufficiency of biological material in the mailed-in specimens. RESULTS The protocol was approved by the Emory University Institutional Review Board (IRB) on March 30, 2020 (Protocol number 371). To date, we have enrolled 159 participants. CONCLUSIONS Defining a conceptual framework for assessing the sufficiency of patient-collected samples for the detection of SARS-CoV-2 RNA and serologic responses to infection is critical for facilitating public health responses and providing PPE-sparing options to increase testing. Validation of alternative methods of specimen collection should include objective measures of the sufficiency of specimens for testing. A strong evidence base for diversifying testing modalities will improve tools to guide public health responses to the COVID-19 pandemic.

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