Summary:
Summary Statement of Deficiencies D0000 An unannounced complaint survey, #2021017593, was conducted on 01/11/2022-01 /20/2022 at ARCpoint Labs of Coral Springs. The facility was 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, record review, and interview the laboratory failed to follow the manufacturer's instruction for performing PhaseScientific Indicaid COVID 19 rapid antigen testing since 01/03/2022. Findings Included: During a tour of the laboratory on 01/11/2022 at 12:00 PM; it was observed that they were using PhaseScientific Indicaid COVID-19 rapid antigen test. Observation of Patient testing on 01/11/2022 at 12:30 PM revealed all 5 tests had timers set for 10 minutes each. Review of the EUA (Emergency Use Authorization) and Instructions for use (IFU) state that the test cassette must be read promptly at 20 minutes "and not earlier to ensure proper test performance." Also, "Results after 25 minutes should not be used." Observations of all 5 Patient tests revealed that the swab was put into the buffer solution then the Testing Person dropped all the liquid out of the buffer solution bottle into the cassette. The IFU state to "Slowly squeeze and apply 3 drops of the Buffer Solution into the sample well". Interview on 01/11/2022 at 1:00 PM the Owner stated that the previous test kit used required 10 minutes to incubate. The testing procedure was corrected while on-site. Interview on 01/14/2022 at 8:02 PM the Owner confirmed that testing with the Indicaid kit started on 01/03/2022 and that there were approximately 2000 Patients performed. 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 --