COVID-19 Reporting Requirements
COVID-19 Case, Testing, and Adverse Vaccine Reaction Reporting Requirements
- Changes to required Provider Reports and timelines, please read below for more information (Updated on 4/7/2022)
- Healthcare providers, not conducting point-of-care testing do not need to submit CMR on all cases, only reporting of hospitalization and/or death of a patient due to COVID-19 is required
- Facilities Certified Under CLIA to Perform Non-waived Testing must report
- All positive and negative SARS-CoV-2:
- Nucleic Acid Amplification Tests (NAAT) results (e.g., PCR, TMA, LAMP, SDA)
- Antibody/serology testing results
- Positive non-NAAT testing (e.g., high throughput antigen testing)
- Facilities With a CLIA certificate of waiver (including rapid testing conducted for screening or diagnostic purposes at schools*, correctional facilities, employee testing programs, long-term care facilities, and rapid testing performed in pharmacies, medical providers offices, and drive-thru and pop-up testing sites):
- Must report al SARS-CoV-2 positive results; however, non-positive results are not currently required to be reported
- Over-the-Counter Self-Tests when preformed without CLIA oversight are not required to be reported; if preformed in a setting regulated under CLIA positive results must be reported
- Thrombosis with Thrombocytopenia Syndrome cases after receipt of Johnson & Johnson vaccine are required to be reported (more information on how below)
- Genomic sequencing on positive PCR labs should be considered for cases of reinfection, vaccine breakthrough, congregated setting clusters, and hospitalized/SNF patients
- Hospitals are required to report (to CDPH) a line list of specified patient level information for each hospitalized person who tests positive for COVID-19
- Click chart to enlarge:
Per State Public Health Officer Order (February 10th, 2022) California Code of Regulations, title 17, sections 2500(b) and 2500(j) are temporarily modified to eliminate the requirements for health care providers to report COVID-19 cases, except as follows:
a. Within 1 working day of identification of hospitalization and/or death of a patient due to COVID-19, health care providers shall report this information (this is in addition to weekly reporting of hospitalized COVID-19 cases by hospitals as required under AFL 21-25).
b. Health care providers conducting point of care testing must still report positive test results consistent with the requirements for laboratories.
- Facilities conducting testing with a CLIA certified waiver need to only report positive tests. Reporting of non-positive results (negative, indeterminate, etc.) is not required at this time.
- This includes rapid testing conducted for screening or diagnostic purposes at schools*, correctional facilities, employee testing programs, long-term care facilities, and rapid testing performed in pharmacies, medical providers offices, and drive-thru and pop-up testing sites.
- *At this time, the following requirements, outlined in Article 8 of Assembly Bill No. 86 applies to reporting of positive tests conducted in schools: Article 8: COVID-19 Reporting and Public Health Requirements 32090. (a) (1) Upon learning that a school employee or pupil at a public or private school campus maintaining kindergarten or any of graded 1 o 12, inclusive, in the state has tested positive for COVID-19 and was present on campus while infectious, the school administrator or other person in charge of the public or private school shall immediately, and in no case later than 24 hours after learning of the positive case, notify the local health officer or the local health officer’s representative about the positive case.
- Facilities certified under CLIA must report all positive and non-positive results
- Testing facilities must continue to follow all State and CLIA requirements for recording and maintaining all laboratory results.
- Tests approved for over-the-counter (OTC) use, when performed by individuals upon their own specimens without CLIA oversight are not required to be reported to public health agencies. Individuals should report their test result according to the instructions recommended by the test. Some home tests have automatic reporting, others have the option to report results through a phone application. If performed in a setting regulated under CLIA, positive results from self-tests are required to be reported.
CMR Reporting through the CalREDIE Provider Portal or the FCDPH Electronic Reporting Form are not required at this time.
Providers are still expected to provide all patients who test positive for COVID-19 with information on isolation guidance: (English), (Español), (Hmong), (Punjabi), (Lao), as well as provide all patients who are close contacts of someone who tests positive for COVID-19 with information on quarantine guidance: (English), (Español), (Hmong), (Punjabi), (Lao).
Hospitalized Cases and Death Reporting
- A phone call within 1 working day is required
- To report, call the FCDPH COVID-19 Provider Line at (559) 600-3332
- Business hours only (no after-hours calls required, cases outside of 8am-5pm can be reported the following day)
- All deaths need to be reported regardless of if the patient was previously reported as a positive case prior to death
AFL-21-25 requires that all California hospitals report specified patient level information for each hospitalized person who tests positive for COVID-19. The reporting requirement is effective July 27, 2021.
Point-of-Care Test by Facility with a CLIA Certificate of Waiver Reporting
If a facility/provider is conducting point-of-care (POC) SARS-CoV-2 testing and has a CLIA waiver, per Title 17 section 2505 of the California Code of Regulations, they are required to report only positive. If a facility is taking samples and then sending the samples to a laboratory to conduct the test, the provider does not need to report all testing as the laboratory will.
- If performing POC testing, then the facility will be required to conduct both provider reporting and laboratory reporting
- All positive results required to be reported within 24 hours to CalREDIE
- Non-positive (negative, indeterminate, etc.) is not currently required
- POC tests include but are not limited to Abbott ID Now, Abbott Binax Now, Quidel Sofia-2, BD Veritor, and LumiraDx
- It is very important that Antigen tests are not reported as PCR tests and vice versa
- Must report data on patients’ race and ethnicity for all COVID-19 test results
Information on how to report labs can be found below.
Laboratory (CLIA certified facility) Reporting
Guidance for Reporting SARS-CoV-2/Influenza Multiplex Test Results
Title 17, California Code of Regulations (17 CCR) section 2500 include COVID-19 and Novel coronavirus infections, and 17 CCR section 2505 was amended to include SARS-CoV-2 and Coronavirus, novel strains. Laboratories are required to report all SARS-CoV-2 related laboratory results.
- Any laboratories approved to test for SARS-CoV-2 must report
- All positive and non-positive (negative, indeterminate, and specimen unsatisfactory) test results from nucleic acid amplification tests (RT-PCR, TMA, LAMP, and SDA) and all positive and non-positive antibody/serology tests for SARS-CoV-2
- SARS-CoV-2 positive results of non-NAAT diagnostic testing (e.g. high throughput antigen testing)
- Reporting should occur through the CalREDIE Electronic Laboratory Reporting system (ELR) or other approved method* within 24 hours from the time the laboratory notifies the health care provider or other person authorized to receive the report.
*All reporting should be electronic; faxes are not an approved method at this time.
- Laboratories must continue to follow all State and CLIA requirements for recording and maintaining all laboratory results
- Laboratories must report data on patients’ race and ethnicity for all COVID-19 test results. Please revise your requisition forms to include this information, and work with the healthcare providers you serve to ensure that demographic information is collected during patient intake so that you can include it when you report results through the CalREDIE system.
- Over-the-counter self-tests conducted in a setting regulated under CLIA, positive results from self-tests are required to be reported.
How to Report Labs
- Transmission of Lab reports through electronic laboratory reporting system
- Reporting through the CalREDIE Manual Lab Reporting Module (MLRM)
- Reporting through the SimpleReport application
- The National Healthcare Safety Network (NHSN) point-of-care test reporting tool for Long-Term Care Facilities (LTCFs) and Skilled Nursing Facilities ONLY)
- This platform can accommodate either manual text entry of results or bulk upload via. csv file
- The Navica app for Binax tests
- Can be downloaded from the Apple App Store and the Google Play Store
- The CDC’s Simple Report platform
- This platform can accommodate either manual text entry of results or bulk upload via .csv file
- Labs should be directly submitted through the CalREDIE system by one of the above methods- DO NOT fax labs directly to the FCDPH
CalREDIE has undergone an update and is no longer compatible with Internet Explorer.
August 26 CDPH Disease Reporting Updates document
Thrombosis with Thrombocytopenia Syndrome Reporting
Per the Health Advisory released by CDPH on April 21, 2021, providers are required to report any cases of Thrombosis with Thrombocytopenia Syndrome (TTS) after receipt of Johnson & Johnson vaccine to the LHD within 1 day.
Providers are to submit to VAERS and then submit a copy of the VAERS report to the LHD. For patients who are Fresno County residents providers will submit to FCDPH via an electronic FCDPH TSS reporting form.
Other Disease Reporting Requirements
Disease reporting is the foundation of public health surveillance. The reporting of specific diseases is critical to public health and required by law. Title 17, California Code of Regulation, Section 2500 (Division 1, Chapter 4, Article 1) requires all heath care providers knowing of or in attendance on a case or suspected case of any of the mandated reportable diseases or conditions to report the case to the local health department where the patient resides. ‘Health care provider’ is defined as a physician, surgeon, veterinarian, podiatrist, nurse practitioner, physician assistant, registered nurse, nurse midwife, school nurse, infection control practitioner, medical examiner, or dentist.
Additionally, Section 2505 requires laboratories to report laboratory-testing results and Section 2508 requires anyone in charge of a public or private school, kindergarten, boarding school, or day nursery to report the presence or suspected presence of any of the reportable diseases to the local health department.
All reports remain confidential.
Learn how to report diseases/conditions.