Template:COVID-19 Testing, Reporting, and Information Management in the Laboratory/Workflow and information management for COVID-19 (and other respiratory diseases)/Laboratory informatics and reporting requirements

4.2 Laboratory informatics and reporting requirements

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." 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. 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. 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. This includes point-of-care and at-home testing results, which are at times more difficult to capture.

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," noting that as of April 21, 2021, all state, territorial, and tribal jurisdictions were onboard with electronic laboratory reporting to the CDC. 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." 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.

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. 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."

4.2.1 ICD, CPT, and HCPCS coding

Related are any test reporting and billing requirements in labs and medical facilities. The International Statistical Classification of Diseases and Related Health Problems (ICD) is a commonly used 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. This guide provides basic information about these codes (which should not be considered legally binding advice); however, see the referenced material (and following citations) for more details concerning those codes:

• The CPT code 87635 has the long descriptor of "Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), amplified probe technique." The American Medical Association's CPT Assistant fact sheet for SARS-CoV-2 reporting proves useful in supplying assistance on how and when to apply this CPT code in reporting.

• Since the pandemic has progressed, numerous other CPT codes have become available. This includes a series of parent and child codes for antibody testing, neutralizing antibody screens, antigen testing, and vaccination. Resources for guidance concerning these codes include the American Medical Association and the American Society of Clinical Oncology (PDF).

• The U.S. government-adopted ICD-10-CM—an authorized version of WHO's ICD-10—has been updated by the CDC and the National Center for Healthcare Statistics. It includes not only codes for conditions associated with COVID-19, but also codes for exposure, screening, and vaccination. The principal diagnosis code "U07.1, COVID-19" is sequenced first for a confirmed COVID-19 diagnosis, followed by any appropriate codes for associated manifestations (though there is an obstetrics exception). CMS's coding guidelines, as well as American Medical Association guidance, may prove useful in choosing the correct codes. The American Society of Clinical Oncology (PDF) is also maintaining a document with ICD-10-CM information.

• Since the pandemic started, new HCPCS codes have been released by the Centers for Medicare & Medicaid Services (CMS). These are to be used solely for Medicare claims. The American Society of Clinical Oncology (PDF) is maintaining a helpful document with that information.

Laboratories analyzing specimens for SARS-CoV-2 must be equipped to implement and handle analytical testing and test orders using the new test codes. However, they also must be able to quickly and accurately transfer vital case information to the appropriate health authority. This may include using other types of codes such as Logical Observation Identifiers Names and Codes (LOINC) and SNOMED-CT codes, which are briefly discussed in the next subsection.

4.2.2 Reporting to local and regional health departments

Given the valuable nature of case reports during an epidemic, health care providers, facilities, and laboratories are being held responsible for sending case data to their local and regional health departments. That information then feeds up to the state-level health department, which then makes its way to the national-level entity responsible for handling epidemiology (in the case of the U.S., the CDC). Significant decisions are typically based on that data. For example, the U.S. CDC has been conducting seroprevalance (determination of the "percentages of people who were previously infected with SARS-CoV-2") surveys of various regions of the United States. The insights and decisions the CDC makes depends on cooperation and proper reporting by state and local health departments.

However, acquiring standardized data at the national level can still be challenging. In the case of the U.S., general disease reporting requirements vary from state to state, with many states encouraging full electronic laboratory reporting (ELR), while some still encourage faxed or emailed reports. Add in the urgency and confusion associated with a pandemic, and COVID-19 reporting requirements prove to vary just as much. Some states' health departments have taken a proactive approach to reporting. For example, Iowa's Department of Public Health has issued several mandatory COVID-19 reporting orders meant to supplement existing reporting rules, including an order requiring all Iowa health care providers and public, private, and hospital laboratories "to immediately report all positive and negative Coronavirus Disease 2019 (COVID-19) testing results to the department." Other states have not been as clear on their reporting requirements, in some cases not having any guidance documents or clear information on their health department website for how providers, facilities, and labs should report COVID-19. In those cases, the presumption is that most labs have contacted the health department for advice or are reporting COVID-19 cases as immediately reportable, based upon the state's existing reporting requirements for immediately reportable diseases.

The CDC, however, maintains a page concerning how to report COVID-19 laboratory data. It's important to note their take on using standard terminology, which is based on their mapping tool LOINC In Vitro Diagnostic (LIVD) Test Code Mapping for SARS-CoV-2 Tests:

This specification supports the use of standardized LOINC and SNOMED Clinical Terms (CT) codes to improve the accuracy of reporting tests for the SARS-CoV-2 virus. Using these harmonized LOINC and SNOMED-CT codes helps ensure that the same type of test is represented uniformly across the United States ... LOINC codes must be used to represent the “question” a test asks of a specimen (e.g., does this specimen have SARS-CoV-2 RNA?), and SNOMED-CT codes must be used to represent the diagnostic “answer” (e.g., what was detected?).

The CDC's Excel-based mapping tool lists the current (and previous) FDA EUAed diagnostic tests with codes for LOINC test order, LOINC test result, SNOMED-CT test description, SNOMED-CT specimen source, and Device Identifier. Ensure that your laboratory is using these LOINC and SNOMED-CT codes for reporting to your local and state health departments.

Table 1 addresses the reporting requirements for the United States' 50 states, while Table 2 covers U.S. territories. If clear reporting guidance specific to COVID-19 could be found, it was described. If no such guidance could be found, then the state's existing guidance and rules regarding disease reporting were referenced. In some cases, the state health departments don't clearly spell out whether a faxed or mailed report is required after immediately phoning in a report. In other cases, it's not clear if ELR—though it exists—is an acceptable form of reporting COVID-19 cases. This ambiguity is stated in the form of a "(?)" found next to the "Y" and "N" for electronic filing and faxing. In all cases, if there is any doubt about reporting requirements, call your local health department to confirm.

Table 1. U.S. state-based COVID-19 reporting requirements State Electronic, including email? (Y/N) Fax? (Y/N) Forms for reporting Contact Additional details Alabama Y N Novel Coronavirus Report Card ALNEDSSsupport@adph.state.al.us Use the Report Card "to submit laboratory-confirmed (or pre-approved epidemiologically-linked) cases or deaths of Novel Coronavirus (COVID-19) to the Alabama Department of Public Health." (Though long-term care facilities and correctional facilities should used different forms.) "Performing 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 via fax (907-563-7868) using the standard Infectious Disease report form or via electronic means. The reporting hotline has been discontinued." "All results (i.e., positive, negative, indeterminate, etc.) must be reported via either integration into existing electronic laboratory reporting (ELR) data feeds, submission of a standard format CSV via SFTP, or fax (907-563-7868). Please email Megan Tompkins ... to inform us about how your facility will report." (See Guidance for Coronavirus Disease 2019 (COVID-19) Testing in Alaska for more.) Arizona Y N Sample ADHS CSV File Sample ADHS Excel File ELR: elr@azdhs.gov "Facilities performing laboratory tests for COVID-19 are required to report both positive and negative results for COVID-19 directly to ADHS pursuant to Executive Order 2021-14. Laboratory is defined in A.R.S. § 36-451(4). Facilities shall report using an electronic format, described below." Consult the laboratory information page for details of all reporting options. Arkansas Y Y (?) Communicable Disease Reporting Form Phone: (501) 537-8969 or 1-800-554-5738 after-hours Arkansas Department of Health doesn't appear to have published any information about specific COVID-19 reporting requirements. As of September 2021, the DoH still hasn't updated its list of mandatory reportable diseases. The state is presumably treating "suspected or confirmed" COVID-19 cases as an immediately reportable event that "are to be reported immediately to the ADH." The language used on its reportable disease instructions suggests that a follow-up fax of the case report isn't required; however, call and confirm with the DoH. The only mention of ELR is a plain page labelled "Public Health Reporting." It would appear users can submit reports via this tool, though registration may be required if new to the tool. California Y N (?) Confidential Morbidity Report Contact: Local health officers   CalREDIE: CalREDIEHelp@cdph.ca.gov or (866) 866-1428 The DPH added COVID-19 to its Reportable Diseases and Conditions lists for health care providers and laboratories early in the pandemic. This health care provider document indicates that a "case or suspected case" of COVID-19 should be reported immediately by phone. The document makes no mention of requiring a follow-up fax or digital report by health care providers. The laboratory document indicates "[l]aboratories must report any initial findings as well as any subsequent findings. ”Any laboratories approved to test for SARS-CoV-2 must report all positive and non-positive (negative, indeterminate, and specimen unsatisfactory) test results from both antigen/molecular and antibody/serology tests for SARS-CoV-2." Laboratory findings are "are reportable to the local health officer of the health jurisdiction where the patient resides by telephone within one (1) hour ... from the time that the laboratory notifies the health care provider or other person authorized to receive the report." Labs are asked to also subsequently report results electronically (ELR) to the California Reportable Disease Information Exchange (CalREDIE) "within one working day of identification." Colorado Y N None CEDRS: lavelle.fernandez@state.co.us   ELR: andrew.horvath@state.co.us "All test results (e.g., positive, negative, and inconclusive) for rapid point-of-care COVID-19 tests must be reported to public health" officials by providers. Additionally, "[a]ll positive, negative, and inconclusive SARS-CoV-2 test results must be reported electronically by laboratories." The disease reporting form and fax methods should not be used. A list of required reporting components and descriptions of digital reporting options are available on the state's COVID-19 reporting page. 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, laboratories 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, which appears to be the preferred method. As for other healthcare providers, per the DPH's COVID-19 response portal: "Providers can now submit a COVID-19 case report online. This is the preferred way to submit COVID-19 case reports." Delaware Y N None Call: 1-888-295-5156   Email: reportdisease@delaware.gov "The Department of Health and Social Service’s March 10, 2020 order requiring all labs to immediately report all tests and all results to the Division of Public Health (DPH) remains in effect. All COVID results, positive AND negative are reportable." "All COVID-19 test results from any laboratory must be reported to DPH via the Delaware Electronic Reporting Surveillance System (DERSS). Providers must confirm with their designated laboratories that they have the ability to transmit results to DERSS through approved methods." Review the provider lab reporting requirements for further details. District of Columbia Y N Notifiable Disease and Condition Case Report Form ELR: informatics.epi@dc.gov   Reporting questions: coronavirus@dc.gov "... healthcare providers must report negative and positive test results for all COVID-19 diagnostic and serologic testing, including point-of-care testing. Reports should be submitted electronically using DC Reporting and Surveillance Center (DCRC), our online reporting system." "Laboratories are recommended to submit COVID-19 results via Electronic Lab Reporting. Please email informatics.epi@dc.gov to initiate the process. Hospitals, skilled nursing facilities, and assisted living facilities should report cases in patients/residents via daily line lists to DC Health." Florida Y N None ELR: ELRPortalSupport@flhealth.gov "Mandatory reporting requirements are outlined by Florida Department of Health Executive Order 20-013, section 381.0031, Florida Statutes, and Florida Administrative Code Chapter 64D-3, and state all health care practitioners, laboratories and facilities, including long-term care facilities, must report both negative and positive COVID-19 test results, including point-of-care rapid test results, within 24 hours of the result being known." As of September 2021, the documentation found on floridahealth.gov appears outdated, however, as the links to the report portal that are indicated are broken. A site, flhealthsource.gov, was found, and it appears to be the current report portal for health care providers and facilities. Georgia Y Y Notifiable Disease Report Form Fax: Based on District Health Office   Call: 1-866-782-4584 Georgia lists COVID-19 as an immediately 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 N (?) Human Infection with 2019 Novel Coronavirus Short Form Fax: (808) 586-4595   ELR: helpdesk@hawaiihie.org Per the Director of Health: "Pursuant to section 325-2, Hawaii Revised Statutes, every physician or health care professional having a client affected by or suspected of being affected by COVID-19 (SARS-CoV-2) and every laboratory director having laboratory data regarding an individual affected by or suspected of being affected by COVID-19 (SARS-CoV-2) shall report the incidence or suspected incidence of COVID-19 (SARS-CoV-2) to the Department of Health in the manner specified by the Department of Health. At this time, all test results shall be reported via the electronic laboratory reporting system." That system is presumed to be this portal. Faxing may no longer be an option; confirm with the Department of Health. 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. As of September 2021, the state has not added COVID-19 to its mandatory reportable diseases list. They simply state that "Labs report their test results to the state, and the number of tests done and the number of people who test positive are 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 IDPH Coronavirus Novel 2019 Case Report Form Fax: Based on Local Health Department   ELR: dph.elrresp@illinois.gov "All providers and testing sites must report to Public Health all individuals tested for COVID-19, in accordance with the Illinois Control of Communicable Diseases Code (77 Ill. Adm. Code 690.200(a)(5)). Mandated reporters, such as health care providers, hospitals and laboratories, by law must report probable or confirmed cases of COVID-19 electronically through Illinois’ National Electronic Disease Surveillance System (I-NEDSS) within 24 hours. If they do not have access to I-NEDSS, they can report by mail, telephone or fax to the local health department ... or, if no local health department is available, to the Illinois Department of Public Health Division of Infectious Diseases at 217-785-7165, TTY (hearing impaired use only) 800-547-0466." Indiana Y Y Confidential Report of Communicable Diseases ELR: (317) 233-7684 or ijameson@isdh.in.gov   Fax: (317) 233-7747 "CDC requires every COVID-19 testing site to report every diagnostic and screening test performed to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (e.g., molecular, antigen, antibody) to the appropriate state or local public health department, based on the individual’s residence. All testing sites must report diagnostics and screening tests within 24 hours of test completion to the appropriate state or local public health department." Their guidance suggest three reporting methods: ELR, REDCap, and Fax. Examine the guidance for further information. Iowa Y N None ELR: Jill Newland "All Iowa health care providers and public, private, and hospital laboratories are required to immediately report all positive and negative SARS-CoV-2 testing results to the department. Immediate reporting is defined as reporting within one day of the test being performed, a standard utilized by the department since its initial March 19, 2020, Mandatory Reporting Order. Reports must be made electronically through the Iowa Disease Surveillance System (IDSS) or other electronic means as directed by the department." Kansas Y N (?) Kansas Reportable Disease Portal Phone: (877) 427-7317   Fax: (877) 427-7318   ELR: kdhe.epitraxadmin@ks.gov "Report antigen or PCR point of care results, positive and negative, directly to KDHE via the Kansas Reportable Disease Portal https://diseasereporting.kdhe.ks.gov/ within 24 hours ... For facilities that do not perform point of care antigen or PCR testing, for antigen or PCR testing done through a reference laboratory or in-hospital laboratory, your facility does not need to report result to KDHE. The laboratory conducting the SARS-CoV-2 test is required to report results to KDHE." Faxing forms appears to be discouraged: "Clinics/hospital systems: if possible, please modify electronic health record systems to cease sending notifiable disease forms to KDHE via email and fax. If your facility uses Epic for its electronic medical records, you may be able to submit reports to KDHE automatically." Kentucky Y N None Email: COVIDKYLAB@ky.gov "If you are a healthcare organization resulting any type of COVID-19 test, you are required to report both positive and negative results to the Kentucky Department for Public Health (KDPH) ... If you are resulting labs at your facility, KDPH requires you to report results through Kentucky Health Information Exchange (KHIE), either electronically through an interface connection or by manually entering results. If you are not currently electronically connected to KHIE, you must manually report these results through KHIE's Direct Data Entry (Lab) feature located in the ePartnerViewer ... You are required to report all positive results within 24 hours of resulting ... You are required to report all negative results within 7 days of resulting." Louisiana Y N None Phone: (504) 568-8295   ELR: elr@la.gov "All facilities performing testing for COVID-19/SARS-CoV-2 are required to report all COVID-19/SARS-CoV-2 results to LDH. This includes rapid testing, point-of-care testing, antibody testing, or any other testing performed for COVID-19. Electronic laboratory reporting (ELR) in HL7 or CSV format is the preferred mechanism for reporting results ... Note: COVID-19 test results sent via ELR should include all results of testing (i.e., positive, negative, indeterminate, etc.)." Also, if you do not have ELR set up or for some reason can't report electronically: "The ELR team will work with you to set up ELR or an alternative reporting method." Maine Y N (?) None Phone: 800-821-5821   Email: disease.reporting@maine.gov A February 2021 update to the state's Control of Notifiable Conditions and Notifiable Conditions List mandates that health care providers and labs must report COVID-19 test results. It mandates that "[l]aboratory reporting must be done electronically through HL7 messaging as specified in this subsection. Electronic reporting required for laboratories is in addition to other reporting requirements specified in this rule." Consult the "New Rules for the Control of Notifiable Conditions" PDF on the disease reporting page for details. It appears COVID-19 should no longer be reported by fax. Maryland Y N (?) Confidential Report: Laboratory Evidence of Certain Communicable Diseases Contact: Local health department The only reporting requirement to be found are in a PDF, item No. MDH 2020-10-01-01, which largely addresses point-of-care testing. Presumably this extends to other types of testing, but it's not clear what other types of testing. It mentions that "[p]ositive, negative, and inconclusive point of care test results shall be reported." The document goes on to explain that electronic reporting is preferred, especially for those labs that are already set up to so do so. Some other electronic format like a CSV file is next preferred, and then, "[i]f the results cannot be sent by HL-7 format or another approved electronic format, they must be immediately submitted to the appropriate local health officer in a manner designated by MDH." Massachusetts N Y No standardized COVID-19 reporting form Contact: Local health departments   MDPH phone: (617) 983-6800   MDPH fax: (617) 983-6813 The State of Massachusetts doesn't appear to have published any collection of information about specific COVID-19 reporting requirements. The state is presumably treating COVID-19 "suspected and confirmed cases" as an immediately reportable event that "should be reported to your local board of health" by phone, or if unavailable, to the Massachusetts Department of Public Health by phone or fax. The MDPH disease reporting web page makes no mention of ELR. Michigan Y Y No standardized COVID-19 reporting form MDSS: Support contacts   Contact: Local health department list in reporting guide The Michigan Department of Health & Human Services has updated its Health Care Professional's Guide to Disease Reporting in Michigan to include detections of SARS-CoV-2. They note that "if the agent is identified by clinical or laboratory diagnosis," the detection (by both healthcare providers and laboratories) "must be reported to the Michigan Disease Surveillance System (MDSS) or local health department within 24 hours." As for how: "Mandatory reporting of communicable diseases can (and, whenever possible, should) be accomplished via the MDSS. The MDSS is a web-based communicable disease reporting system developed for the state of Michigan." If unable to electronically report, contact the local health department using the directory in the disease reporting guide. Minnesota Y Y COVID-19 Case Report Form Fax: (651) 201-5743   Phone: (651) 201-5414 or (877) 676-5414   ELR: health.ELRmeaningfuluse@state.mn.us "The Minnesota Department of Health (MDH) is requiring all mandated reporters to report any cases and deaths due to SARS-CoV-2 to MDH within one working day." This includes health care facilities, medical laboratories, and in special cases veterinary laboratories. Case report forms can be faxed or case reports submitted by phone. On a separate page discussing laboratories, the DoH further discusses ELR. Read that for more details. Mississippi Y (?) N Reportable Diseases and Conditions form Phone: (601) 576-7725 or 1-800-556-0003; for weekends, holidays and after 5pm: (601) 576-7400; Email: clia-msdh@msdh.ms.gov The Mississippi State Department of Health states: "All COVID-19 results must be reported to the Mississippi State Department of Health at this time." However, it gives no further guidance specifically for commercial laboratories or health care providers testing for SARS-CoV-2. Presumably the MSDH is considering COVID-19 a Class 1A disease, required to be "reported directly to the Department of Health by telephone within 24 hours of first knowledge or suspicion." The MSDH also has an online disease reporting tool (account required); however, it's not clear if it is equipped to received COVID-19 reports. Missouri Y Y sFTP Excel template   Disease Case Report form sFTP: (573) 526-5271   Fax: (573) 751-6417   ELR: ELR@health.mo.gov The Missouri Department of Health and Senior Services has officially added COVID-19 to its list of immediately reportable conditions, including a waiver "to require that all positive and negative results for COVID-19 are sent directly to DHSS. Now, all laboratories must report directly to DHSS." They add that "[l]aboratories are encouraged to report via electronic means." Alternatively, labs may also submit a report to the Bureau of Reportable Disease Informatics (BRDI) via fax. "[M]edical providers (non-laboratories) also have an obligation to submit disease case reports (form CD-1) to DHSS. However, under the current suspension, providers do not have to report negative results if those results are being reported by an outside lab. Providers are expected to submit a case report on any non-negative results as the additional information on the case report is required for public health intervention." Montana N Y (?) No standardized COVID-19 reporting form Contact: Local health department   DPHHS phone: (406) 444-0273 The Montana Department of Public Health and Human Services doesn't appear to have published any information about specific COVID-19 reporting requirements. The state is presumably treating COVID-19 like its other reportable diseases: "whether suspected or confirmed" the case "must be reported immediately to your local health jurisdiction as required by the Administrative Rules of Montana." If the local public health jurisdiction is unavailable, a call can be placed to the MDPHHS. It is not clear if laboratories should report both positive and negative results, though news reports have shown that the DPHHS is reporting both positive and negatives. The disease reporting web page makes no mention of ELR. Nebraska N N Health Care Provider Confidential Communication form   Laboratory Summary of Reportable Diseases, Poisonings and Organisms Phone: Based on county The Nebraska Department of Health and Human Services provides little in the way of specific guidance for reporting COVID-19. They simply state: "Any patient (+) for COVID-19 virus should be immediately reported to local/state public health office." They define "immediate notification" as "required to call by telephone to a live public health surveillance official within 24 hours of detection." This apparently includes providers currently on ELR. Labs and healthcare providers should verify if any additional reporting (fax, ELR) is required. As the pandemic has progressed, reporting transparency and requirements have also changed, becoming more controversial; contact your local health department for the latest requirements. Nevada N Y Confidential Disease Reporting Form Contact: Local health department list in reporting form Nevada DHHS guidance states "all in-state and out-of-state laboratories who are processing and testing samples from Nevada residents are required under severe penalties to report all COVID-19 test results to the Division of Public and Behavioral Health within 24 hours from analysis." Its guidance appears to suggest a phone call for such notification. According to the state's disease reporting form, this phone call should be done in addition to faxing a report. "All cases, suspect cases, and carriers must be reported within 24 hours." It's not clear if ELR is being accepted for COVID-19 reporting. New Hampshire N Y COVID-19 Case Report Form Phone: (603) 271-4496   Fax: (603) 271-0545 Health care providers and laboratories should immediately report suspect and confirmed cases of COVID-19 to the New Hampshire Department of Health and Human Services. It seems likely the DPHHS prefers both a phone call and a faxed report, though it's not explicitly stated. The case should likely be "reported within 24 hours of diagnosis or suspicion of diagnosis." The NHDHHS disease reporting web page makes no mention of ELR. An online test result reporting form is available, per the state's General Provider COVID-19 Resources page. New Jersey Y N (?) No standardized COVID-19 reporting form ELR: See quick-start guide   Local health departments "[T]he New Jersey Domestic Security Preparedness Task Force hereby directs that commercial laboratories operating in New Jersey report all COVID-19 test results to the New Jersey Department of Health beginning March 23, 2020. The results of all COVID-19 tests performed before this date shall be included in the initial report. Subsequently, results shall be sent daily, and included results not previously reported. Information shall be transmitted no later than 8:00 p.m. each day through the Department of Health’s CDRSS platform. Specific data reported shall include positive, negative, and inconclusive test results. This directive shall supplement, not supplant, any other existing reporting requirements." From that statement, it's not clear if laboratories should also be immediately phoning their results to the health department in addition to ELR over CDRSS. New Mexico N Y (?) Notifiable Condition Report Form Phone: (505) 827-0006   Fax: (505) 827-0013 The New Mexico Department of Health doesn't appear to have published any information about specific COVID-19 reporting requirements. The DoH is presumably treating "confirmed or suspected" COVID-19 cases as an immediately reportable event that "require immediate reporting by telephone to Epidemiology and Response Division." It's not clear if a faxed report is also required. The DoH disease reporting web page makes no mention of ELR. New York Y N Confidential Case Report - DOH-389   Universal Reporting Form - PD-16 Contact: Local health departments   ECLRS: eclrs@health.ny.gov The New York Department of Health states: "Positive results must be immediately reported to the local Department of Health by the laboratory performing the test, per established guidance, and all test results should be reported by the laboratories into New York State Department of Health’s Electronic Clinical Laboratory Reporting System (ECLRS) four times a day." The established guidance appears to be found in the state's updated reporting instructions, which now includes COVID-19 as a disease that "should be reported immediately to local health departments by phone followed by submission of the confidential case report form (DOH-389). In NYC use case report form PD-16." This means "within 24 hours of diagnosis." The instructions indicate case reports should be mailed. Both health care facilities and laboratories should report. North Carolina Y Y COVID-19 Confidential Communicable Disease Report Contact: Local health departments   Fax: (919) 733-0490 Per NCDHHS's clinical diagnostic laboratory guidance: "each person in charge of a laboratory providing diagnostic service in this State and any other health care provider licensed in this State that provides diagnostic service [is required] to report the results of all COVID-19 testing to the Department of Health and Human Services." An electronic reporting process appears to have been added later in 2020. Ohio Y Y Ohio Confidential Reportable Disease form Contact: Local health districts   ELR: ELR@odh.ohio.gov In March 2020, the Ohio Department of Health ordered "confirmed cases of COVID-19 be reported immediately as a Class A disease pursuant to Ohio Adm. Code 3701-3-02(A) to the local health district in which the person resides (or the local health district wherein the person is being medically evaluated if the person's residence is unknown or not in Ohio)." Physicians, medical care facilities, and laboratories are encouraged to report positive cases. Per the state's communicable disease requirements, Class A diseases should be reported immediately by phone, with a follow-up HEA 3334 Ohio Confidential Reportable Disease form. That requirements doc also states "follow-up reports can also be made electronically through direct entry into the Ohio Disease Reporting System (ODRS) or through Electronic Laboratory Reporting." Oklahoma Y Y Reportable Disease Card for Healthcare Providers (Blue Card)   Reportable Disease Card for Laboratories (Yellow Card) PHIDDO: adservice@health.ok.gov   Phone: (405) 271-4060 Fax: (405) 271-6680   ELR: AnthonyL@health.ok.gov According the DoH's COVID-19 reporting page, COVID-19 cases should optimally be reported by some digital means (HL7, manually entered CSV, exported CSV from information system). The DoH is presumably treating "laboratory results indicating" (i.e., "upon suspicion, diagnosis, or positive test") COVID-19 as an immediately reportable event. This also holds true for healthcare providers. The Public Health Investigation and Disease Detection of Oklahoma (PHIDDO) system is apparently the preferred method. Oregon Y Y COVID-19 Report Form Contact: Local public health authority   Fax: (971) 673-1100   Oregon COVID-19 Reporting Portal or ELR: (971) 673-1111 "The Oregon Health Authority (OHA), Public Health Division, is temporarily adopting OAR 333-017-0800 and OAR 333-018-900, which add a definition of COVID-19 and adds COVID-19 to the list of diseases reportable to public health authorities within 24 hours. Positive test results for COVID-19 must be reported within 24 hours and negative COVID-19 results within one working day." "Both medical laboratories and health care providers are required to report COVID-19 test results to the state and local public health authorities." According to state law, reports should be initially submitted by phone call, with a follow-up report either through the Oregon COVID-19 Reporting Portal or a fax. ELR is also an option. Pennsylvania Y N No standardized COVID-19 reporting form (use PA-NEDDS) PA-NEDSS: 1-877-724-3258 From the Pennsylvania Department of Health: "All entities conducting testing to identify SARS-CoV-2, the virus that causes COVID-19, are required to report positive, inconclusive/indeterminate, and negative results to PA-NEDSS within 24 hours of test completion. PA-NEDSS is a secure, web-based system used in Pennsylvania for disease reporting and surveillance." Rhode Island Y Y None Phone: (401) 222-2577 or (401) 276-8046 after hours   Fax: (401) 222-2488 Per the Rhode Island Department of Health: "For reporting positive results from testing you have ordered and sent out through a laboratory system, report positive results only." You may report by secure email or fax. "For reporting point-of-care and rapid test results performed at your site, report all positive and negative results." Note the specific email addresses depending on the test type. ELR is not mentioned. South Carolina Y Y (?) No standardized COVID-19 reporting form Contact: Local public health office   ELR: MUHELPDESK@dhec.sc.gov or SCIONHELP@dhec.sc.gov Per the South Carolina Department of Health and Environmental Control: "Please notify DHEC of positive results. COVID-19 cases and deaths are urgently reportable per the South Carolina List of Reportable Conditions. They must be reported by phone within 24 hours to the appropriate regional health department." Supplemental guidance: "Positive and negative test results for COVID-19 must be reported to DHEC urgently within 24 hours by all entities performing testing, including testing at point-of-care or at-home specimen collections processed by laboratories." That guidance adds: "Facilities that are not already submitting results via Electronic Lab Reporting (ELR) or DHEC's secure reporting portal (SCIONx) should contact MUHELPDESK@dhec.sc.gov to inquire about ELR submission, or SCIONHELP@dhec.sc.gov to inquire about other reporting options." South Dakota Y Y South Dakota Confidential Disease Report (online/HTML) Phone: (605) 773-3737 or 800-592-1861   Fax: (605) 773-5509 "SD-DOH would like to remind medical providers, hospitals, and laboratories that cases of COVID-19, caused by the SARS-CoV-2 virus, are considered immediately reportable in South Dakota (under Coronavirus Respiratory syndromes)." The SD-DOH and the state laws don't make clear what reporting method is best for Category I diseases, only that they should be reported immediately. Under "how to report," they list, in order, online reporting, phone, fax, and mail. The SD-DOH disease reporting web page makes no mention of ELR. Tennessee Y Y PH-1600 Case Report Form Fax: (615) 741-3857   Phone: (615) 741-7247   ELR: ceds.informatics@tn.gov "Healthcare providers who receive positive COVID-19 test results on their patients or patients in their facility [should report]." "Laboratories performing COVID-19 testing should be reporting these results electronically via ELR or our emergency spreadsheet template. If you are a laboratory that needs to report via one of these methods, please email ceds.informatics@tn.gov." These entities "should report within 24 hours of receiving a COVID-19 diagnosis, positive lab report on a patient, and/or becoming aware of a suspected or confirmed COVID-19 associated death." Please submit a case report by filling out the PH-1600 form on all NAAT, PCR and antigen positive COVID-19 test results from facility or commercial labs (this includes any NAAT, PCR or antigen positive patients tested via Point of Care testing); you do not need to submit further information on a lab result from the TDH Public Health Laboratory." The Tennessee Department of Health lists two reporting options: faxing the PH-1600 form and positive lab report or sending it electronically (via Morbidity Report or ELR). Texas Y Y Infectious Disease Report (Single case)   Infectious Disease Report (Multiple cases) Contact: Local health department   ELR: COVID‑19ELR@dshs.texas.gov "On July 29, 2021, Governor Greg Abbott ordered every public or private entity that is utilizing an FDA-approved test, including an emergency use authorization test, for human diagnostic purposes of COVID-19, shall continue to submit to DSHS, as well as to the local health department, daily reports of all test results." This includes positive, negative, and indeterminate results. "To comply with the Governor’s orders, DSHS is expediting an alternative method of accepting specific CSV formatted files for submitters who are unable to submit via HL7 format." ELR registration can be performed online. Utah Y Y Utah Public Health Confidential Morbidity Report Fax: (801) 538-9923   Email: reporting@utah.gov   Phone: 1-888-EPI-UTAH   ELR: edx@utah.gov The Utah Department of Health added COVID-19 to its reportable conditions in May 2020 for both manual and electronic reporters. "All test results are reportable. This includes positive/reactive, indeterminate, equivocal, and negative/non-reactive." "Electronic reporters must report laboratory results within 24 hours of finalization. Manual reporters must report immediately notifiable conditions within 24 hours of identification and standard notifiable conditions within three business days of identification." Details on ELR are limited, though an ELR guide for hospitals can be found here. Vermont Y (?) Y No standardized COVID-19 reporting form Phone: (802) 863-7240   Fax: (802) 951-4061   ELR: (802) 651-1619 or AHS.VDHELRSupport@vermont.gov The Vermont Department of Health states: "All COVID-19 results (positive, negative, etc.) are required to be reported to the Vermont Department of Health within 24 hours of test report completion" Its April 2021 guidance adds: "The report shall be made by telephone, in writing, or electronically to the Department of Health, Epidemiology Program." Additional details can be found here. Virginia Y N See portals linked below Contact: Local health department The VDH states: "All COVID-19 reports from clinicians or facilities based on point-of-care tests should be reported using the VDH Point-of-Care (POC) Portal, not the Confidential Morbidity Portal. For other reports not involving POC testing, healthcare providers should continue to report patients with suspected or confirmed COVID-19 through the Confidential Morbidity Portal." They add that "[a]ll COVID-19 test results should be reported to VDH within 24 hours." Washington Y N None Contact: Local health jurisdiction The Washington State Department of Health has adopted several emergency rules to ensure reporting compliance. The DoH notes: "Facilities administering point-of-care (POC) testing for COVID-19 must report all their COVID-19 testing results to the Washington State Department of Health." (See here for more about POC reporting requirements.) "Washington State (under WAC 246-101) requires laboratories to report all COVID-19 results (including positive, negative, inconclusive; and other results based on State Health Officer Letters) to the LHJ of the patient's residence. ELR, national flat file, and electronic case reporting options are available for labs. West Virginia N (?) Y 2019 Novel Coronavirus (COVID-19) Case Report Form Contact: Local health departments "Report suspect or confirmed cases immediately to the local health department by phone and follow up with written report." "Providers and LHDs should submit this report to the Division of Infectious Disease Epidemiology by fax at 304-558-8736 for all cases of COVID-19." It's not clear if ELR is an acceptable form of reporting COVID-19 cases. Wisconsin Y Y Wisconsin COVID-19 Patient Information F-02700 Contact: [hhttps://www.dhs.wisconsin.gov/lh-depts/counties.htm Local health department]   WEDSS: DHSWEDSS@wisconsin.gov "The state epidemiologist declared COVID-19 a Category I reportable disease per a memo issued on Feb. 4, 2020. Health care providers and laboratories must report confirmed or suspected cases to the Department of Health Services (DHS) within 24 hours of detection. To relieve the reporting burden, DHS waived the requirement (April 6 Memo) for notifying local health departments by telephone of suspected and confirmed cases as long as cases are reported to the Wisconsin Electronic Disease Surveillance System (WEDSS)." Additional rules apply. See "Reporting and surveillance guidance" here. Wyoming N Y Confidential Disease Report form Phone: 1-888-996-9104   Fax: (307) 777-5573 "Providers and laboratories must report positive [SARS-CoV-2] laboratory tests from commercial reference laboratories to WDH by faxing copies of the laboratory report form to 307-777-5573." According to Wyoming's Reportable Diseases and Conditions List, this faxed report would be in addition to immediate notification by phone. Additionally, "[h]ospital and reference labs with ELR capacity must report positive and negative results," as well as viral detection and serology results. According to that document, COVID-19 isn't a disease preferred for ELR. Confirm with the health department.

Table 2. U.S. territory-based COVID-19 reporting requirements Territory Electronic, including email? (Y/N) Fax? (Y/N) Forms for reporting Contact Additional details American Samoa N N (?) Can't locate the AMS COVID-19 Investigation Form Contact: Facebook page   Phone: (684) 633-5871 or (684) 633-5872 According to American Samoa's report Territory of American Samoa's Response and Action Plan to Combat the Cornoavirus Pandemic, resources for testing are unfortunately thin. It makes mention that the American Samoa Department of Health should be notified "immediately of probable or confirmed cases of COVID-19." It also mentions completing an "AMS COVID-19 Investigation Form." "If there is more than one case of novel coronavirus in a household, local area or facility, or an outbreak is suspects, notify Command Post immediately at (684) 633-5871 or (684) 633-5872." Guam N Y (?) No standardized COVID-19 reporting form Contact: Office of Epidemiology and Research - Phone: (671) 735-7289, Fax: (671) 734-2066 It's clear that Guam is having laboratories report cases of COVID-19, but no reporting requirements for COVID-19 (or any other diseases) can be located on the Department of Public Health and Social Services website. Perhaps contact the Office of Epidemiology and Research for more information. Northern Mariana Islands N N No standardized COVID-19 reporting form Contact: CHCC laboratory The CNMI Department of Public Health has indicated that laboratory testing has been primarily been performed by the Guam Public Health Laboratory, but due to them not being able to meet demand, the CNMI DPH will ship samples to Diagnostic Laboratory Services in Honolulu, Hawaii. Presumably those labs are responsible, in part, for reporting results back to the CNMI. Puerto Rico Unknown Unknown Unknown Phone: (787) 765-2929   Email: contactus@salud.pr.gov The Departamento de Salud de Puerto Rico has a relevant document OA 440 Sobre la distribución, manejo, administración y reporte de los resultados de las pruebas de COVID-19 concerning reporting results. U.S. Virgin Islands N Y Notification of Infectious Disease Form Phone: (340) 626-1654   Territorial fax: 1-888-400-8620 "Make an IMMEDIATE telephone report to the USVI Department of Health at 626-1654 then send the completed form IMMEDIATELY (within 24 hrs) by fax to 1-888-400-8620. If an immediate report is required after regular working hours, please call 626-1654." Additional COVID-19 information here.