As outlined in CMS QSO 20-38, facilities conducting tests under a CLIA certificate of waiver are subject to regulations that require laboratories to report data for all COVID point-of-care antigen testing completed, for each individual tested, every time they are tested. This includes all staff and residents for which the facility is conducting COVID testing with the point-of-care antigen testing devices in house under their Washington DOH Medical Test Site/CLIA Waiver. All positive and negative test results must be reported.
Currently, reporting mechanisms are not in place for facilities to meet this CLIA reporting requirement in Washington State. There is a three-week grace period to allow systems to be determined/developed within each state. DSHS is working with DOH this week to work out the reporting process.
In the interim, each facility must maintain a facility log or spreadsheet that contains all the reporting information within the HHS Lab Reporting Guidelines. This data must be reported within 24 hours of test completion, daily, to the appropriate state or local public health department, based on the individual’s residence. Providers need to record this information within the time frames for facility records until the reporting methodology is established. Until a reporting system is determined from DOH/DSHS, you must maintain the reporting data onsite in the facility conducting the testing and have it readily available. WHCA has created a template spreadsheet that includes the data reporting elements outlined in CMS requirements.
In addition to reporting in accordance with CLIA requirements, facilities must continue to report outbreaks to the Department CRU hotline, ALTSA reporting portal, and CDC NHSN. Continue to notify the LHJ of any COVID-19 outbreak.
For additional information on reporting requirements and WHCA Reporting Spreadsheet, see:
