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ā€‹ā€‹Laboratory Reporting and Enforcement Guidelines

California Reporting Requirements for SARS-CoV-2/COVID-19

Accurate and timely reporting of data by laboratories to public health authorities is a critical component of Californiaā€™s disease control efforts. Reporting is all the more important during the SARS-CoV-2/COVID-19 emergency.

Disease reporting requirements are set by the California Department of Public Health (CDPH) Division of Communicable Disease Control (DCDC), which maintains a list of reportable diseases and conditions in Section 2500 and Section 2505 of Title 17 of the California Code of Regulations. Section 2500 requires every healthcare provider who is aware of a case or suspected case of a reportable disease to report the case to the local health officer for the jurisdiction where the patient resides. Section 2505 requires every clinical or public health laboratory director in whose laboratory a test indicates evidence of a reportable disease to report the test results to the local health officer for the jurisdiction where the patient resides. Laboratories are required to report through to the state electronic reporting system (ELR) or a local electronic reporting system linked to the state ELR. This requirement applies to all California-licensed laboratories, including those located outside California.

Please note that local health jurisdictions (LHJs) may have their own reporting requirements in addition to State and federal reporting laws. Healthcare providers and laboratories should always check with their local health officer to ensure compliance with local requirements that may apply to their locations.

CalREDIE (California Reportable Disease Information Exchange), the statewide ELR system for communicable disease reporting, is maintained by the CalREDIE program in DCDC. DCDC also maintains and updates reportable disease lists and administers reporting regulations.

As the oversight agency for clinical and public health laboratories in California, Laboratory Field Services (LFS) assists CalREDIE by investigating complaints and enforcing compliance with laboratory reporting requirements.

To enable laboratories to report in compliance with the requirements and provide the State with accurate data, DCDC and LFS have prepared these guidelines.

Reporting Requirements

On March 9, 2020, the list of reportable diseases in Title 17, California Code of Regulations (17 CCR) section 2500 was amended to include COVID-19 and Novel coronavirus infections, and 17 CCR section 2505 was amended to include SARS-CoV-2 and Coronavirus, novel strains, effective immediately.

On July 28, 2020, the reporting regulations at 17 CCR section 2500 and 2505 were amended to change reporting times and require additional patient information.

Clinical and public health laboratories testing for SARS-CoV-2 must report through the CalREDIE Electronic Laboratory Reporting system (ELR):

  • The following list outlines current requirements for reporting SARS-CoV-2 related laboratory results. This document includes updated information on requirements for reporting negative results for SARS-CoV-2 antigen tests.
    • Federal regulations require laboratories to report both positive and non-positive antigen test results. Any laboratories conducting SARS-CoV-2 antigen testing must report all positive and non-positive test results through the CalREDIE Electronic Laboratory Reporting system (ELR) within twenty four hours from the time the laboratory notifies the health care provider or other person authorized to receive the report.
    • Please note that laboratories no longer need to report SARS-CoV-2 results by telephone within one hour.
    • Laboratories must report data on patientsā€™ 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.
    • For more information about ELR, please visit the CDPH CalREDIE ELR webpage.
    • Please use the encoding guidelines for ELR messages for SARS-CoV-2. The LOINC codes are pre-release codes, developed for special use. You can find them, and check for future updates, at the LOINC website.
    • In addition, please use the following SNOMED codes:
      • 260373001 Detected
      • 260415000 Not detected
      • 419984006 Inconclusive
      • 125154007 Specimen unsatisfactory
  • Per Title 17, California Code of Regulations section 2505, laboratory results for influenza and SARS-CoV-2 are required to be reported. For laboratories using SARS-CoV-2/Influenza multiplex test platforms, please see the guidance about reporting SARS-CoV-2/Influenza multiplex test results to CalREDIE (PDF). Please email CalREDIEHelp@cdph.ca.gov if you have any questions or need assistance.

How to Report to CalREDIE

Laboratories have three options for reporting. For additional information about these options please contact CalREDIEHelp@cdph.ca.gov.

  • Electronic laboratory reporting (ELR) to CalREDIE is the preferred reporting method.
    • CalREDIE is used by laboratories, healthcare providers, local health departments, and CDPH for communicable disease reporting and surveillance activities.
    • Reporting to CalREDIE is the method required in regulations and allows the reporting entity to meet the reporting requirements of Title 17 section 2505.
    • CalREDIE reporting allows for timely reporting of results.
    • Over 350 laboratories currently transmit ELR to CalREDIE.
    • Results automatically appear in CalREDIE and local Disease Incident Staging Area (DISA).
    • Typically takes 4-6 weeks for new labs to accurately setup ELR interface.
      • During this time labs are required to fax positive results directly to LHJs.
    • ALL laboratories should be working towards reporting via ELR.
  • .CSV File Submission
    • Laboratories that cannot report via ELR can submit results in a correctly formatted .CSV file.
    • A correctly formatted .CSV file can be fed into CalREDIE and results will appear as if the result came via ELR. Improperly formatted files cannot be uploaded.
    • Correct .CSV formatting can be labor intensive for laboratories.
    • Until the .CSV file is correctly formatted and approved by the CalREDIE team to go into CalREDIE, labs are instructed to report results to the local health department.
    • For information on how to submit .CSV files to CDPH, contact CalREDIEHelp@cdph.ca.gov for instructions on how to obtain an SFTP account.
  • Manual Laboratory Reporting Module (MLRM)
    • MLRM is most appropriate for settings with small volumes and which do not have the capability to submit ELR messages.
      • This could be POC sites as well as small volume submitters who may find submission of a .CSV file difficult.
    • Only SARS-CoV-2 results can be reported via MLRM.
    • Each user must complete an account request form, available on the CalREDIE website.
    • MLRM allows a user to log in to CalREDIE and submit results.
    • CalREDIE uses the patientā€™s address to route the report to the local health department where the patient resides.
      • MLRM users DO NOT need to report results to the local health department if they report results via MLRM.
      • Entities in Los Angeles County and San Diego County are not eligible to use MLRM and should contact Los Angeles County Public Health or San Diego County Public Health for instructions on how to report to them.

  • All labs are required by Title 17, California Code of Regulations section 2505 to submit electronic data for reportable diseases to CDPH. While onboarding to the electronic reporting system using any of these methods, labs should submit results to local health departments.

Complaints

Laboratory Field Services works with CalREDIE to investigate complaints about reporting. The Department relies especially on LHJs to report labs that are not reporting appropriately, local testing sites and events that are not reporting, and local entities conducting point-of-care testing but not reporting. To enable LFS to respond quickly and efficiently to complaints, please use the following process:

  • LHJs should first check the CalREDIE Lab Status List of connected laboratories (sent weekly from CalREDIE to LHJs) to determine if the laboratory is connected to the CalREDIE ELR system.
  • If the laboratory is not listed, submit the complaint to CalREDIE at CalREDIEHelp@cdph.ca.gov.
    • The CalREDIE team will contact the laboratory to assist in establishing connectivity or utilizing an alternative reporting method and forward the information to LFS for investigation if appropriate.
  • If the laboratory is listed, submit the complaint to LFS at LFSCOVID@cdph.ca.gov or LFSLabComplaints@cdph.ca.gov.
    • Please include the following information:
      • Laboratory name and address
      • Documents showing a laboratory is reporting test results, but not reporting to CalREDIE. Below are some examples:
        • Copy of patient test report
        • Copy of labā€™s report to the LHJ providing a list of positive and non-positive (negative, indeterminate, and specimen unsatisfactory) results
        • LFS will maintain confidentiality of all submissions.
      • If possible, include the following information:
        • The date the laboratory performed the testing (found on the patient test report)
        • The date the laboratory reported the test result to the authorized healthcare provider who requested the test (found on the test report)
        • The date and time the laboratory reported results to the LHJ
        • Number of patients reported for a specific date, with patient ID numbers
      • If available, include:
        • A copy of written correspondence sent by the LHJ notifying the lab they need to report to CalREDIE
        • A copy of laboratoryā€™s response to the LHJ notification letter
    • LFS will confirm the laboratoryā€™s reporting status with CalREDIE and then review the complaint to determine investigation and enforcement steps. LFS may contact the complainant for further details.
    • LFS maintains confidentiality of all submitted documents. LFS does not comment on investigations in progress to avoid compromising the investigation and to protect privacy.
    • To expedite processing of your complaint, please download and complete the LFS Complaint form (PDF).

Enforcement

To ensure compliance with reporting regulations, Laboratory Field Services provides information about SARS-CoV-2/COVID-19 reporting requirements, including notification of recent regulatory changes, on the LFS website. LFS also provides this information to newly licensed and registered laboratories when it sends notice of approval of their applications for licensure.

When LFS is notified that a licensed laboratory is not complying, it first confirms with the CalREDIE program that the laboratory is not in compliance with the requirements. If CalREDIE verifies non-compliance, LFS then initiates the following progressive enforcement plan:

  1. LFS issues an initial notice to the laboratory of its failure to report with the applicable state reporting requirement.
    • The laboratory has 15 calendar days to respond to LFS with an explanation as to its non-compliance.
    • The laboratory may provide additional information or evidence to LFS disputing the allegation of failure to report.
  2. After the 15-day period has elapsed, if the laboratory does not respond to the initial notice or continues in non-compliance, LFS issues a formal notice to the laboratory warning that
    • Failure to report constitutes a violation of state law and may result in potential civil/administrative penalties.
    • LFS intends to impose sanctions on the laboratory if it does not respond to the letter within 10 calendar days.
  3. If the laboratory does not respond or does not provide a satisfactory response within the 10-day period, LFS proceeds with imposition of a civil money penalty and a directed plan of correction.
  4. Upon receipt and review of the laboratoryā€™s plan of correction evidencing the steps it will take to come into and maintain compliance with the reporting mandate, LFS determines if additional sanctions such as on-site monitoring or license revocation/suspension would be appropriate.

LFS handles questions about the progress of an enforcement process on a case by case basis, as there may be situations where enforcement involves further investigation, or other circumstances that prevent sharing information.

Resources

Contact CalREDIE at CalREDIEHelp@cdph.ca.gov:

  • For information about how to connect to CalREDIE.
  • For questions about reporting, including what needs to be reported and how to report results.

Contact Laboratory Field Services at LFSCOVID@cdh.ca.gov:

  • To submit a complaint about non-reporting.
  • For questions about enforcement.

Reporting requirements for healthcare providers: California Code of Regulations, Title 17, Section 2500

Reporting requirements for laboratories and other facilities testing for SARS-CoV-2: California Code of Regulations, Title 17, Section 2505

 

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