CDC is currently hosting training on the new Point-of-Care Test Reporting Tool in the National Healthcare Safety Network (NHSN) Covid-19 module. The slides for this training are available here and a recording will be available on the NHSN site in the coming days. What follows below is a run-down of key information and helpful hints for complying with this requirement.

Details of the Requirement

Per this HHS document updated on October 19, 2020, CMS-certified nursing homes must utilize the NHSN system to meet lab data reporting requirements for reporting point-of-care testing conducted in the nursing home (see item #4 under “Methods for Submission”). This new mandate replaces the previous requirement to report these tests to the state health department. CDC will share data reported through NHSN with the state/local health department. CMS has announced that they will initially exercise a short period of discretionary enforcement of this requirement for providers who are unable to report due to security limitations (see below, Level 3 SAMS Access); however, the provider must be able to demonstrate efforts to attempt to acquire access and meet reporting requirements.

Level 3 SAMS Access

In order to be able to report this data in NHSN, the individual reporting the data must have Level 3 security access through Secure Access Management Services (SAMS). Level 3 access is granted through a SAMS grid card, which is unique to the individual. It is recommended that more than one employee at the nursing home have Level 3 access.

If no one in your nursing home has Level 3 access, email NHSN@cdc.gov with the subject line “Enhancing Data Security” immediately. The process to upgrade from Level 1 to Level 3 could take up to 4 weeks and is outlined here.

If only your NHSN Facility Administrator has Level 3 access, the Facility Administrator can initiate this process by assigning new users and user rights under the “Users” tab within the NHSN system. This process is outlined here. Once the Facility Administrator has assigned user rights, the new user will receive an email from NHSN to agree to the Rules of Behavior. Once the individual has signed the Rules of Behavior, this will prompt the system to generate an invite email to the new user to begin the SAMS process.

Reporting Reminders

As with all reporting in NHSN, compliance will be measured based on verification of data. To ensure that your data is correctly attributed to your nursing home, always verify the following when entering data:

• Facility type. Instructions for changing facility type can be found here.
• Facility CMS certification number (CCN). Instructions for editing your CCN can be found here.
• CLIA certification number. Instructions for editing your CLIA certification number can be found in this presentation on slide 25. If your CLIA certification number is incorrect, CDC will be unable to share your data with your state/local health department.

Initial Challenges and Concerns

No CSV File Template. Currently, no CSV file template exists for reporting this data. This means that providers must manually input data for each resident and staff member for whom a point-of-care test is administered. This creates a significant burden on the front end and while some data will auto-populate for subsequent data entries for the individual resident or staff member, other data will require repeated manual input. LeadingAge has advocated to CDC and CMS on the urgent need for a CSV file template. CDC is considering this template for “future enhancements” but a template is not expected in 2020.

Potential Duplicative Reporting. Lab data reporting requirements were updated through the CARES Act and on June 4, 2020, HHS released guidance to require that COVID-19 testing be reported to state and local health departments. States developed their own processes and platforms for reporting by providers, including nursing homes utilizing point-of-care tests. With the revised requirement issued on October 19, we have learned that some states are requiring nursing homes to continue reporting data through the state process. LeadingAge has expressed this concern to CDC and CMS. CDC is working with states to eliminate the need for duplicative reporting. Nursing homes should contact their state entity to determine any state-level reporting requirements for point-of-care testing.

Confusing Reporting Directives. CMS-certified nursing homes are required to begin reporting immediately through NHSN. However, a number of scenarios exist in which the provider would continue reporting to the state rather than reporting through NHSN. Two common scenarios are as follows:

• The nursing home does not have Level 3 SAMS access: As noted above, a nursing home must have Level 3 SAMS access in order to report point-of-care testing through NHSN. If no one in the nursing home has Level 3 access, the nursing home must continue to report through the state process until Level 3 SAMS access is secured.
• The type of test is not listed in NHSN: Currently, the NHSN point-of-care test reporting tool only has options for reporting point-of-care tests conducted on Abbott BinaxNOW test cards, BD Veritor instruments, and Quidel Sofia instruments. If the nursing home is conducting testing using an alternative point-of-care test or device, these tests must be reported through the state process.

LeadingAge has expressed concern to HHS about requirements being enforced on nursing homes when the system is clearly not ready. We are pleased with CDC and CMS’s efforts thus far to streamline reporting requirements by making this reporting process available but urge swift resolution of the identified issues.