Description of Event or Problem · 0
I AM WRITING AS A STATE TESTED NURSING ASSISTANT (STNA) AT (B)(6), TO FORMALLY REPORT SERIOUS CONCERNS REGARDING THE USE OF EXPIRED COVID-19 ANTIGEN TEST KITS ON RESIDENTS AND STAFF. THIS PRACTICE HAS BEEN ONGOING FOR APPROXIMATELY FOUR WEEKS. MULTIPLE FRONTLINE STAFF MEMBERS SHARE CONCERNS ABOUT THIS PRACTICE BUT ARE FEARFUL OF RETALIATION FROM FACILITY MANAGEMENT IF THEY RAISE ISSUES DIRECTLY. I AM BRINGING THIS FORWARD IN GOOD FAITH, NOT ONLY REGARDING THE EXPIRED COVID-19 TESTS, BUT ALSO IN LIGHT OF OTHER ONGOING ISSUES WITHIN THE FACILITY THAT WARRANT FURTHER OVERSIGHT. THROUGH CONFIRMATION WITH BOTH THE LOCAL HEALTH DEPARTMENT AND THE MANUFACTURERS, I VERIFIED THAT NO FDA-AUTHORIZED EXPIRATION DATE EXTENSIONS EXIST FOR THE LOTS IN USE, WITH THE EXCEPTION OF ONE (B)(4) LOT THAT WAS ONLY EXTENDED THROUGH JULY 2025. DESPITE THIS, MANAGEMENT CONTINUES TO DIRECT STAFF TO USE THESE EXPIRED TESTS TO SCREEN STAFF AND RESIDENTS. ADDITIONALLY, I HAVE ATTACHED SUPPORTING DOCUMENTATION, INCLUDING WRITTEN CONFIRMATION FROM THE MANUFACTURER OF THE CORDX COVID-19 ANTIGEN TEST THAT NO EXTENSION WAS GRANTED. DESPITE THIS, SOMEONE WITHIN THE FACILITY¿S MANAGEMENT TEAM HAS MANUALLY LABELED THE INDIVIDUAL TEST BOXES AND THE LARGER SHIPPING CONTAINER TO FALSELY INDICATE THAT EXTENSIONS HAD BEEN AUTHORIZED. FOR CLARITY, HERE IS A SUMMARY OF THE TEST KITS IN USE: CORDX COVID-19 AG TEST, LOT: US2424801, REF: CO291-2, EXPIRATION: 2025-9-10. (B)(4) COVID-19 ANTIGEN RAPID TEST, LOT: 245CO20129, EXPIRATION: 2025-04-28. ACCESSBIO CARESTART COVID-19 ANTIGEN HOME TEST, LOT: CP23B49, EXPIRATION: 2024-11-14. (B)(4) COVID-19 RAPID HOME TEST, LOT: 0006712436, EXPIRATION: 2025-1-31, EXTENDED EXPIRATION: 2025-7-31. THIS SITUATION RAISES SIGNIFICANT CONCERNS RELATED TO: RESIDENT AND STAFF SAFETY DUE TO UNRELIABLE TEST RESULTS. VIOLATION OF FEDERAL INFECTION PREVENTION REQUIREMENTS (42 CFR §483.80, F-TAG 880). POSSIBLE FALSIFICATION OR MISREPRESENTATION OF MEDICAL DEVICES. A WORKPLACE CULTURE WHERE STAFF FEAR RETALIATION FOR REPORTING SAFETY CONCERNS. THANK YOU FOR YOUR TIME AND ATTENTION TO THIS MATTER, AND FOR YOUR COMMITMENT TO PROTECTING RESIDENTS AND STAFF IN (B)(6) LONG-TERM CARE FACILITIES. PATIENT CODE: 4580. DEVICE CODES: 2528, 2911.REFERENCE REPORT #MW5176459, #MW5176460, #MW5176462.