Summary:
Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the laboratory failed to follow the manufacturer's instructions for specimen collection for one of one tests reviewed. Findings: 1. Upon entering the facility at approximately 08:30 AM on November 30, 2021, a sign in the lobby was observed stating the following "Please do not collect COVID-19 testing samples in the lobby. Please go to your vehicle or step outside to self collect the sample." 2. During the entrance interview at approximately 09:00 AM on November 30, 2021, the Technical Supervisor (TS) confirmed that the laboratory performed BD SARS-CoV-2 and Panther Fusion SARS-CoV-2 assays. 3. Review of the United States Food & Drug Administration website for In Vitro Diagnostics Emergency Use Authorizations (EUA) - Molecular Diagnostics Tests for SARS-CoV- 2 revealed that neither assay system was listed with the attribute for home collection. 4. Review of the Instructions for Use (IFU) for the SARS-CoV-2 Assay (Panther Fusion System) in the "Intended Use" section revealed "The Panther Fusion SARS- CoV-2 assay is a real-time RT-PCR in vitro diagnostic test intended for the qualitative detection of RNA from SARS-CoV-2 isolated and purified from nasopharyngeal(NP) and oropharyngeal (OP) swab specimens, nasopharyngeal washes/aspirates or nasal aspirates, and bronchoalveolar lavage specimens (collected by a healthcare provider) and anterior nasal (nasal) and mid-turbinate nasal swab specimens (collected under observation of or by a healthcare provider) from individuals who meet COVID-19 clinical and/or epidemiological criteria, as well as NP and OP swab specimens (collected by a healthcare provider) and nasal and mid-turbinate nasal swab specimens Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- (collected under observation of or by a healthcare provider) from any individual, including from individuals without symptoms or other reasons to suspect COVID-19." 5. Review of the IFU for BD SARS-CoV-2 Reagents for BD Max (Trademark) System in the "Intended Use" section revealed "The BD SARS-CoV-2 Reagents for BD MAX (Trademark) System is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal, anterior nasal, mid- turbinate, and oropharyngeal swab specimens, nasopharyngeal wash/aspirate or nasal aspirates obtained from individuals suspected of COVID-19 by their healthcare provider or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested at least weekly and with no more than 168 hours between serially collected specimens." 6. At approximately 12:30 PM on November 30, 2021, the laboratory director (LD) and TS confirmed that laboratory personnel were not collecting the SARS- CoV-2 samples. The LD and TS confirmed that patients were provided with instructions for collection but not observed collecting the samples for SARS-CoV-2 testing in their vehicle or outside the laboratory. -- 2 of 2 --