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3. Workflow and information management for COVID-19 (and other pandemics)

3.2 Laboratory informatics and reporting requirements

Epidemiology can broadly be split into two categories: descriptive epidemiology and analytical epidemiology. Descriptive epidemiology involves studies and other activites 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. Analytical epidemiology allows for the testing of those hypotheses using both experimental and obsevational studies, as well as control groups. Similarly, the collection and use of quality experimental and observational data is vital for proving or disproving hypotheses. In both cases, proper reporting of data is critical to the success of epidemiologists' response to outbreaks and pandemics, as well as the credibility of their research.

The proper reporting of COVID-19 case data is no exception. In the United States, the CDC has taken a standardized approach to collecting reports on "individuals with at least one respiratory specimen that tested positive for the virus that causes COVID-19." Their COVID-19 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, and clinical diagnosis and treatment procedures. Currently, the CDC is asking local and state health departments to submit case reports, and asking healthcare providers to contact those health departments when "concerned that a patient may have COVID-19." The CDC has also slimmed its reporting requirements, limiting reporting of "persons under investigation" to areas where testing must be forwarded to the CDC due to insufficient capacity to test locally. Electronic reporting using the CDC's system is preferred, but they have a protocol for those areas unable to submit electronically. Canada has similar reporting expectations, with their own case report form and electronic data submission process through the Public Health Agency of Canada. And in the European Union, member countries and the U.K. are asked to report through the Early Warning and Response System.

Somewhat related are any internal reporting requirements, particularly for test reporting in labs and medical facilities. The International Statistical Classification of Diseases and Related Health Problems (ICD) is a system of diagnostic codes for classifying diseases, including nuanced classifications of a wide variety of signs, symptoms, abnormal findings, complaints, social circumstances, and external causes of injury or disease. Their ICD-10-CM code set has been modified to include lab testing codes for COVID-19, as has the Current Procedural Terminology (CPT) code set. Green and Bradley provide insight into these additions, as does the American Academy of Pediatrics.

Laboratories analyzing specimens for SARS-CoV-2 therefore must be equipped to not only handle analytical testing and test orders using the new test codes, but they also must be able to quickly and accurately transfer vital case information to the appropriate health authority.

Table 1. U.S. state-based COVID-19 reporting requirements State Electronic file (Y/N) Fax? (Y/N) Forms for reporting Contact Additional details Alabama Y N Novel Coronavirus Report Form ALNEDSSsupport@adph.state.al.us "Providers who are either reporting laboratory results for patients tested by a commercial or clinical laboratory (not tested by the BCL) or reporting deaths among patients with positive results must complete" the report form. "Laboratories are required to report all negative and positive COVID-19 virus test results electronically (faxes do not count). If not already enrolled, laboratories will need to manually enter test results directly into the surveillance system." Email the contact to enroll staff access to the system. Alaska Y Y Confidential Infectious Disease Report Form COVID Reporting Hotline: 1-877-469-8067   Urgent situation: 907-269-8000 or 800-478-0084 (after-hours)   ELR: megan.tompkins@alaska.gov "Providers must report laboratory-confirmed cases of COVID-19 to SOE by either leaving a message on the COVID Reporting Hotline (1-877-469-8067) or via fax using the standard Infectious Disease Report Form." "[A]ll results both positive and negative must be reported via either integration into existing electronic laboratory reporting (ELR) data feeds or fax (907-563-7868). Please email Megan Tompkins ... to inform us about how your facility will report." Arizona Y Y Sample Aggregate Weekly Submission Form Sample ADHS CSV File Sample ADHS Excel File Fax: (602) 364-3199   ELR: elr@azdhs.gov "[A] laboratory as defined in A.R.S. § 36-451(4) shall report all COVID-19 test results (positive and negative) to the Arizona Department of Health Services in an electronic format as follows: a. For laboratories reporting to the Arizona Department of Health Services through electronic lab reporting ('ELR'), results of all COVID-19 tests; b. For laboratories not reporting to the Arizona Department of Health Services through ELR, a weekly aggregate number of total COVID-19 tests performed and their results." If reporting is accomplished through mail or fax, use the Sample Aggregate Weekly Submission Form. "Aggregate reporting does NOT replace mandatory laboratory reporting requirements per Arizona Administrative Code R9-6-204."   "ADHS has created a new electronic option for reporting results of COVID-19 in-house testing as an alternative to Health Level Seven (HL7) electronic laboratory reporting or direct entry into MEDSIS. This can now be accomplished through a standardized spreadsheet or comma separated value (CSV) file format." Arkansas California Colorado Y Y General Communicable Disease Reporting Form Fax: (303) 782-0338   CEDRS: lavelle.fernandez@state.co.us   ELR: andrew.horvath@state.co.us The state doesn't appear to have specific rules or a reporting form for laboratory reporting of COVID-19. Presumably labs are reporting COVID-19 as is required for any communicable disease. The state lists multiple ways to report a case: calling, faxing a General Communicable Disease Reporting Form, through CEDRS, or by using ELR. The also offers guidance for healthcare providers. "Any suspected or confirmed case or outbreak of COVID-19 should immediately be reported to the local or state public health agency. To report, utilize the [Outbreak COVID-19 Outbreak Report Form]. Send this form to your local public health agency OR to CDPHE by securely emailing a completed form to: cdphe_haioutbreak@state.co.us." Connecticut Y Y 2019 Novel Coronavirus (COVID-19) Case Report Form   Reportable Laboratory Findings, Form OL-15C Fax: (860) 629-6962   ELR: dph.elr@ct.gov Presumably labs are reporting COVID-19 as is required for any communicable disease. This has traditionally been done using Form OL-15C sent through mail or fax, as well as ELR. "Providers can now submit a COVID-19 case report online. This is the preferred way to submit COVID-19 case reports." Delaware Y N No standardized COVID-19 reporting form Call: 1-888-295-5156   Email: reportdisease@delaware.gov "COVID-19 is a reportable condition to the DPH. Any positive test results from any laboratory must be reported to DPH via the Delaware Electronic Reporting Surveillance System (DERSS). If you have a strong clinical suspicion that a patient may be infected with COVID-19 based on clinical symptoms and epidemiological factors (e.g., close contact with a confirmed case, recent travel to an area with sustained transmission), contact the DPH Office of Infectious Disease Epidemiology at 1-888-295-5156, or report through reportdisease@delaware.gov within 24 hours leading to submission of test samples to a commercial lab to allow for surveillance and monitoring as appropriate." The state makes no mention of reporting negative COVID-19 test results. Florida Y Y No standardized COVID-19 reporting form Fax: (850) 414-6894   ELR: MUElectronicLabReporting@flhealth.gov or ELR@flhealth.gov "Commercial laboratory results for COVID-19 will either be reported through electronic laboratory reporting (ELR), faxing, or phone calls from laboratories. Results received at the Bureau of Epidemiology will be sent to counties via Merlin. Bureau of Public Health Laboratories test results are reported to [county health departments] through Merlin and they are mailed to the ordering providers." In separate documentation, the state notes that both positive and negative COVID-19 laboratory results should be reported. As for health care providers and facilities, they must report a [specific set of persons related to COVID-19 to the County Health Departments. Georgia Y Y Notifiable Disease Report Form   Notifiable Disease Reporting Requirements Fax: Based on District Health Office   Call: 1-866-782-4584 Georgia lists COVID-19 as an immeadiately reportable disease condition. "All Georgia physicians, laboratories, and other health care providers" are encouraged to call their District Health Office or the main number. The state is also accepting COVID-19 reports through its SendSS online application. Hawaii Y (?) Y Person Under Investigation (PUI) and Case Report Form Fax: (808) 586-4595   ELR: helpdesk@hawaiihie.org "Per the Hawaii Administrative Rules, Chapter 11-156, the Person Under Investigation (PUI) and Case Report Form must be completed for any person who tests POSITIVE for COVID-19. Please fax the completed form to the Disease Outbreak Control Division at (808) 586-4595. COVID-19 is considered an URGENTLY REPORTABLE condition." It's not entirely clear if laboratories can use ELR through the Hawaii Health Information Exchange for COVID-19 reporting. They simply state: "Results for patients who have been tested for COVID-19 are incorporated into their records in the HHIE Community Health Record." Idaho N Y No standardized COVID-19 reporting form Phone: (208) 334-5939   Fax: (208) 332-7307   ELR: PublicHealthMU@dhw.idaho.gov The Idaho Department of Health and Welfare doesn't appear to have published any information about COVID-19 reporting requirements. They simply state that "Labs will report their results to the state, and those numbers will be posted on this website each day." Presumably this means that labs should be following the state's reportable diseases protocol for reporting "within one working day of identification or suspicion" using phone or fax. No standardized reporting form appears to exist. It's not clear if ELR is being used to report COVID-19 cases. Illinois Y Y No standardized COVID-19 reporting form Fax: Based on Local Health Department   ELR: DPH.Helpdesk@illinois.gov or DoIT.Helpdesk@Illinois.gov The Illinois Department of Public Health doesn't appear to have published an information about COVID-19 reporting requirements. However, given their laboratory reporting requirements in general, COVID-19 is nearly certain to require "immediate" reporting, which to the state means within three hours. Its laboratory reporting requirements document recommends contacting the local health department to send the report. However, ELR through Illinois’ National Electronic Disease Surveillance System (I-NEDSS) appears to be the preferred method. Indiana Y Y Confidential Report of Communicable Diseases ELR: (317) 233-7684 or ijameson@isdh.in.gov   Fax: (317) 233-7747 "You should report both positives and negatives the same way you report all other reportable disease conditions to ISDH. This is primarily through electronic laboratory reporting (ELR) through the ISDH NBS system. If your facility currently reports labs through ELR to ISDH, contact Irene Jameson to set up COVID-19 reporting (317-233-7684 or ijameson@isdh.in.gov). If your facility does not currently report through ELR, please have your infection preventionist (IP) report through a morbidity report. Provide a pdf of the lab report to your IP as they will need to attach this file when submitting their report. ISDH is not onboarding new ELR/NBS customers currently. Alternatively, you can fax positive reports to 317-233-7747." Such reporting should be done within 24 hours of test completion. Iowa Y Y Disease Reporting Card ELR: Jill Newland   Fax: (515) 281-5698 "All Iowa health care providers and public, private, and hospital laboratories are required to immediately report all positive and negative Coronavirus Disease 2019 (COVID-19) testing results to the department. Reports must be made electronically through the Iowa Disease Surveillance System (IDSS) when a facility has electronic transmission capabilities, otherwise reports can be faxed to 515-281-5698." Kansas N Y Kansas Reportable Disease Form Phone: (877) 427-7317   Fax: (877) 427-7318 "COVID-19 is a reportable disease, so you must have a mechanism for reporting both positives and negatives to KDHE." However, the KDHE doesn't appear to have any additional laboratory reporting instructions for COVID-19. It's not explicitly clear, but the state is presumably treating COVID-19 as a four-hour (within four hours of test completion) reportable disease. According to its reportable diseases guidance: "For 4-hour reportable diseases report to the KDHE Epidemiology Hotline: 877-427-7317. For all other reportable diseases fax a Kansas Reportable Disease Form and any lab results to your local health department or to KDHE: 877-427-7318 within 24 hours or by the next business day." The KDHE disease reporting web page makes no mention of ELR. Kentucky N Y COVID-19 Person Under Investigation (PUI) Report Form   Kentucky Reportable Disease Form Fax: (502) 696-3803 "If the test result for COVID-19 is positive, please fax the completed PUI form to the KDPH secure fax line at 502-696-3803 along with the EPID-200 Reportable Disease Report Form." It's not clear if any COVID-19 reporting is being performed using ELR.

3.3 Additional benefits of laboratory informatics in disease testing and public health

In a 2013 research paper published in the journal BMJ Quality & Safety, El-Kareh et al. analyzed and described the state of diagnostic health information technology (HIT). They noted that without the aid of HIT, clinicians are more error-prone, leaving them "vulnerable to fallible human memory, variable disease presentation, clinical processes plagued by communication lapses, and a series of well-documented ‘heuristics,’ biases, and disease-specific pitfalls." Appropriate, well-designed HIT systems are capable of helping clinicians and laboratorians by providing more timely access to information, improved communication, better clinical reasoning and decision making, and improved workflows, as well as a reduction in diagnostic errors, and, as a result, improved patient safety and health outcomes.

From a public health perspective, the application of informatics to disease surveillance, reporting, and health promotion is also vital. Winters-Miner et al. note in particular the value of using informatics tools and methods to implement predictive analytics and data mining into public health. They use disease prevention and biosurveillance as major examples. We could, for example "analyze large populations of people to quantify risks related to public health, and help physicians to develop intervention programs for those patients at highest risk of some ailment or medical condition." Additionally, through the use of syndromic surveillance systems (tools aiding in the detection of indicators leading up to disease diagnosis for individuals and populations), they suggest that outbreaks can be better detected at local and national levels, and public health measures can be better implemented, increasing public awareness and hindering the spread of disease.

https://www.nature.com/articles/s41746-019-0110-4 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4204239/ https://www.nap.edu/read/21794/chapter/7#241 https://www.mlo-online.com/home/article/13017228/poct-made-easier-with-informatics