Summary:
Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on surveyor observation, review of manufacturer instructions and interview with technical consultant (TC) 9/9/21, the laboratory failed to dispose of one expired test kit for the Acceava Strep A testing. One patient was tested after the expiration date of 8/31/21. Findings: Surveyor observed one Acceava Strep A test kit, Lot #STA9092004, available for use on the laboratory counter top with an expiration date of 8/31/21. Review of manufacturer instructions revealed "Storage and Stability...Do not use beyond the expiration date.". Interview with surveyor at approximately 12:00 p.m. confirmed the test kit for Acceava Strep A expired on 8/31/21. She also confirmed one patient was tested on 9/1/21. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --