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Use of Self-Administered Tests Clarified for Nursing Home Routine Testing

The Department of Health's (DOH) Wadsworth Center Clinical Laboratory Evaluation Program (CLEP) has clarified its position on the use of self-administered point-of-care tests for purposes of routine screening tests of nursing home staff. With the increase in staff screening tests as a result of the new requirement to routinely test nursing home staff who are not "up-to-date" in their vaccination doses, LeadingAge NY members have asked about the permissibility of allowing staff to self-administer tests in their own homes. LeadingAge NY asked DOH via email "whether they may satisfy routine and outbreak staff testing using at-home tests performed in the staff member’s home (i.e., off-site)."

CLEP staff responded to this question via email from Valerie Deetz, deputy director in DOH's Office of Primary Care and Health Systems Management, on March 21, 2022, indicating that at-home COVID-19 tests may not be used off-site (e.g., in the employee's home) for purposes of fulfilling routine staff testing requirements. However, when used on-site, non-nursing staff may collect the specimens and interpret the results from rapid tests, if they are properly trained. Specifically, the email states:

"Current CMS guidance for the testing of nursing home staff, which was recently revised on 3/10/22, states that facilities can meet the testing requirements through the use of rapid point-of-care (POC) diagnostic testing devices or through an arrangement with an offsite laboratory. The guidance does not indicate that test results obtained by staff using over the counter at-home tests can be used to meet the testing requirements. Therefore, we cannot authorize staff to perform routine testing at home using the at-home test kits.

However, non-nursing staff are allowed to interpret the results when performing POC testing under a limited service laboratory registration as long as the non-nursing staff have been trained on how to perform the test and their competency assessed.

Staff performing testing must receive training on how to perform the tests when new tests or devices are introduced or when newly hired. Training should be provided by a qualified person (e.g., experienced co-worker, facility expert, or outside consultant) with knowledge of how to perform the test and the ability to evaluate the effectiveness of the training (e.g., does staff understand how to perform the test and are they performing the test correctly). On-the-job training includes the following steps:
For the Trainer:
• provides a step by step demonstration of how the specimen is collected and the test is performed;
• observes how the trainee collects and performs the test and provides feedback and additional instruction to ensure accurate and reliable test results;
• documents in writing available for the department’s review that the training has been completed by the trainee;
• evaluates that the trainee has performed the test according to the package insert; and
• educates how to identify invalid results and/or test kit or device problems.

For the Trainee:
• reads the package insert or device user’s manual;
• observes the trainer demonstrating how the test is performed;
• performs the test according to the manufacturer’s package insert while the trainer observes; and
• correctly interprets the test result.

Competency assessment is a process to make sure that staff are following the proper test procedure after initial training and should be performed annually. Ways to perform competency assessment include:
• Supervisor/director watching staff collect the specimen and perform testing to verify that the person is following the proper test procedure;
• Having staff re-test previously tested samples to check that the same result is generated. Discrepant results are investigated."

These tests would be performed under the facility's limited service lab registration certificate. Accordingly, results must be reported by the facility.

Contact: Karen Lipson, klipson@leadingageny.org, 518-867-8838