Summary:
Summary Statement of Deficiencies D0000 An unannounced complaint survey, #2023013527, was conducted on 10/30/23 at Sarkis Clinical Trials. The facility was found not in compliance with 42 CFR 493, Requirement for clinical laboratories. 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 observation and interview, the facility failed to follow manufacturer instructions by using an expired Covid antigen testing kit on 14 patients tested in 2023. Findings include: During the tour of the laboratory, one kit of "Care Start Covid- 19 Antigen" tests with lot number CH21A28 and expiration date of 11/30/21 was located. The box was opened with 6 test strips remaining out of 20. The laboratory provided a list of 14 patients who were potentially tested with the expired kit. Interview with an Access Bio (manufacturer of Care Start Covid-19 Antigen) technical services representative via telephone on 10/30/23 at 9:38am confirmed the test kit was past any extended expiration date. Interview with the Director of Clinical Trials on 10/30/23 at 9:42am confirmed the Care Start kit with expiration date of 11/30 /21 is the only Covid-19 test kit on site. 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 --