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Michigan State and Local Public Health COVID-19Standard Operating ProceduresInterim September 2021Table of ContentsBackground . 2Standardized Surveillance Case Definition for COVID-19 . 3Patients with Persistent or Recurrent Positive Tests4Work-Related Case Classification . 5Inconclusive Test Results . 5Out-of-State Case Referrals . 6Deduplication and Case Classification for COVID-19 Cases6Emerging SARS-CoV-2 Variants and Whole Genome Sequencing . 6Multisystem Inflammatory Syndrome in Children (MIS-C) and Adults (MIS-A) . 8Test Interpretation . 10At-Home Tests. 11Testing Criteria . 11Higher Education Testing . 12Hospitalization Status . 13Death Reporting and Investigation . 13Outbreak Reporting and Investigation . 14Outbreak Definitions. 14Outbreak Investigations . 19Local Public Health Reporting to MDHHS . 19Secondary Cases . 20Where Outbreaks Are Counted . 21Referring Outbreak Associated Cases to Other Jurisdictions21Cases Associated with Gatherings . 22Recovery. 22Case Investigation and Contact Tracing . 23CDC Travel Guidance . 28COVID-19 Vaccine . 29Potential Vaccine Breakthrough / Failure Cases: Follow-up31Contact Tracing and Case Investigation Realignment . 33Website Resources. 33COVID-19 Monitoring Travelers and Contacts Using the MDHHS Outbreak Monitoring System (OMS) 34Appendix 1: Sample language for letter to confirm completion of isolation/quarantine . 43Appendix 2: Sample Death Reporting Form. 44Appendix 3: Sample MIHAN Message for College/University Outbreaks . 45Appendix 4: Report of COVID-19 Positive Test Result to Public Health. 46Appendix 5: Deduplication Instructions for COVID-19 . 47Appendix 6: COVID-19 Case Report Form (CRF) Interim Tip Sheet . 50

BackgroundOn December 31, 2019, an outbreak of pneumonia in Wuhan City, Hubei Province, China was reported to theWorld Health Organization (WHO). This outbreak is now known to be caused by the 2019 novel coronavirus. OnFebruary 11, 2020, the WHO announced the official name for the disease as COVID-19. On March 11, the COVID19 outbreak was characterized as a pandemic by the WHO. As of September 7, 2021, over 221 million caseshave been reported worldwide, including over 4.5 million deaths. 1 In the US, over 40 million confirmed cases,including over 649,000 deaths, have been reported. 2 In Michigan, over 961,000 confirmed cases, including over20,300 deaths, have been reported as of September 7, 2021. 3Patients with COVID-19 may experience fever, cough, dyspnea, chest tightness, pneumonia, chills, new loss oftaste or smell, headache, sore throat, muscle pain, and gastrointestinal distress. Healthcare providers shouldconsider COVID-19 for patients being evaluated with fever and acute respiratory illness. The most currentinformation from the Michigan Department of Health and Human Services (MDHHS) may be found atwww.michigan.gov/coronavirusThe MDHHS is working closely with Local Health Departments (LHDs) and the Centers for Disease Control andPrevention (CDC) during this pandemic. The MDHHS Community Health Emergency Coordination Center(CHECC), which was fully activated on February 4, 2020, is also assisting the coordination of response efforts.This includes hosting healthcare and LHD conference calls and distributing Health Alert Network messages.Bureau of Infectious Disease Prevention (BIDP) staff were deployed to the EPI DESK to assist withcommunications and guidance and to liaise with State agencies (e.g., Department of Licensing and RegulatoryAffairs). Duties include compiling and analyzing LHD SITREPs and providing data and epidemiologic situationalawareness to the Director’s SITREP and to CHECC staff to assist in decision-making.Guidance is subject to change as more is learned about the virus, as the pandemic progresses, and as CDCrecommendations are updated. For the most current information and MDHHS Epidemic Orders, go towww.michigan.gov/coronavirus. On June 22, 2021, Governor Whitmer announced measures to relax COVID-19restrictions, increasing capacity for indoor and outdoor settings. Several MDHHS COVID-19 epidemic orderswere rescinded, but others remain in effect including the May 5 - Testing in Skilled Nursing Facilities, Homes forthe Aged, and Adult Foster Care Facilities and the May 21, 2021 Requirements for Residential Care FacilitiesThe CDC provides guidance for public health recommendations for potential risk of COVID-19 exposure,addressing travel-associated exposures, community-related exposures, and healthcare-associated exposures forhealthcare professionals. COVID-19 Travel Recommendations by Destination has been posted lers/map-and-travel-notices.html. For the most currentinformation, visit: www.cdc.gov/coronavirus/2019-ncov/index.html. This guidance is subject to change as moreis learned about the virus, the outbreak progression, and as CDC recommendations are updated.1Worldwide case counts available at the 2019-nCoV Global Cases by Johns Hopkins f62US case counts available at: dates/cases-in-us.html3Michigan case counts available at: https://www.michigan.gov/coronavirus2

Standardized Surveillance Case Definition for COVID-19On July 13, 2021, the CDC approved the Council of State and Territorial Epidemiologist (CSTE) interim positionstatement for COVID-19: “Update to the standardized surveillance case definition and national notification for2019 novel coronavirus disease (COVID-19).” This interim position statement updates the standardized casedefinition for COVID-19 and retains COVID-19 as a nationally notifiable condition. This supersedes the April 2020and August 2020 CSTE COVID-19 interim position statements. The full position statement can be found gr/ps/ps2021/21-ID-01 COVID-19.pdfCase ClassificationClinical CriteriaIn the absence of a more likely diagnosis: Acute onset or worsening of at least two of the following symptoms: fever (measured or subjective),chills, rigors, myalgia, headache, sore throat, nausea or vomiting, diarrhea, fatigue, congestion or runnynose OR Acute onset or worsening of any one of the following symptoms: cough; shortness of breath; difficultybreathing; olfactory disorder; taste disorder; confusion or change in mental status; persistent pain orpressure in the chest; pale, gray, or blue-colored skin, lips, or nail beds, depending on skin tone; inabilityto wake or stay awake OR Severe respiratory illness with at least one of the following: clinical or radiographic evidence ofpneumonia, or acute respiratory distress syndrome (ARDS)Laboratory CriteriaConfirmatory laboratory evidence: Detection of SARS-CoV-2 RNA in a post-mortem respiratory swab or clinical specimen using a diagnosticmolecular amplification detection test performed by a CLIA-certified provider, OR Detection of SARS-CoV-2 by genomic sequencingPresumptive laboratory evidence: Detection of SARS-CoV-2 specific antigen in a post-mortem obtained respiratory swab or clinicalspecimen using a diagnostic test performed by a CLIA-certified providerSupportive laboratory evidence: Detection of antibody in serum, plasma, or whole blood specific to natural infection with SARS-CoV-2(antibody to nucleocapsid protein), OR Detection of SARS-CoV-2 specific antigen by immunocytochemistry in an autopsy specimen, OR Detection of SARS-CoV-2 RNA or specific antigen using a test performed without CLIA oversightEpidemiologic LinkageOne or more of the following exposures in the prior 14 days: Close contact* with a confirmed or probable case of COVID-19 disease, OR Member of an exposed risk cohort as defined by public health authorities during an outbreak or duringhigh community transmission.*Close contact is generally defined as being within 6 feet for at least 15 minutes (cumulative over a 24hour period). However, it depends on the exposure level and setting; for example, in the setting of anaerosol-generating procedure in healthcare settings without proper PPE, this may be defined as anyduration. Data are insufficient to precisely define the duration of exposure that constitutes prolongedexposure and thus a close contact.3

Vital Records CriteriaA person whose death certificate lists COVID-19 disease or SARS-CoV-2 or an equivalent term as an underlyingcause of death or a significant condition contributing to death.Criteria to Distinguish a New Case from an Existing CaseThe following should be enumerated as a new case: SARS-CoV-2 sequencing results from the new positive specimen and a positive specimen from the mostrecent previous case demonstrate a different lineage, OR Person was most recently enumerated as a confirmed or probable case with onsets date (if available) orfirst positive specimen collection date for the classification 90 days prior, OR Person previously reported as ‘suspect’ but now meets the criteria for a confirmed or probable case.Case ClassificationsConfirmed Meets confirmatory laboratory evidence.Probable: Meets clinical criteria AND epidemiologic evidence with no confirmatory or presumptive laboratoryevidence for SARS-CoV-2, OR Meets presumptive laboratory evidence, OR Meets vital records criteria with no confirmatory laboratory evidence for SARS-CoV-2.Suspect: Meets supportive laboratory evidence*** with no prior history of being a confirmed or probable case.***For suspect cases (positive serology only), jurisdictions may opt to place them in a registry for otherepidemiological analyses or investigate to determine probable or confirmed status.Patients with Persistent or Recurrent Positive TestsCurrent guidance indicates that for persons who remain asymptomatic following recovery from COVID-19,retesting is not necessary during the first 3 months after symptom onset. If there is a positive test in anasymptomatic person within 3 months of the initial symptom date (or specimen collection date if onset is notavailable), do not enumerate for surveillance purposes.For persons who develop new symptoms consistent with COVID-19 during the first 3 months since the date ofsymptom onset of the most recent illness episode, retesting may be warranted if alternative etiologies for theillness cannot be identified. If reinfection is suspected, repeat isolation and contact tracing may be needed. Thedetermination of whether a patient with a subsequently positive test is contagious to others should be made ona case-by-case basis, in consultation with infectious diseases specialists and public health authorities, afterreview of available information (e.g., medical history, time from initial positive test, RT-PCR Ct values, andpresence of COVID-19 signs or symptoms). Any information on a potential re-infection, including caseinvestigation and contact tracing events, should be added to the previously reported case in the MichiganDisease Surveillance System (MDSS) if it is within 3 months of the first case.If there is a positive molecular test in an asymptomatic person more than 3 months after a person’s symptomonset (or specimen collection date of first positive test), clinicians and public health authorities should considerthe possibility of reinfection. Until more is known, the determination of whether a patient with a positive test inthese situations is contagious to others should be made on a case-by-case basis.Persons who develop new symptoms consistent w