Summary:
Summary Statement of Deficiencies D3005 FACILITIES CFR(s): 493.1101(a)(3) Molecular amplification procedures that are not contained in closed systems have a uni-directional workflow. This must include separate areas for specimen preparation, amplification and product detection, and, as applicable, reagent preparation. This STANDARD is not met as evidenced by: Based on direct observation of the facilities layout, observation of the of the laboratory's SARS-CoV-2 RNA (COVID-19) Polymerase Chain Reaction (PCR) testing, and interviews with the technical supervisors (TS) and testing personnel (TP) on February 15, 2022 on its molecular amplification procedure; it was determined that the laboratory failed to ensure that the molecular amplification procedures which are not contained in closed systems have a unidirectional flow with separate areas for specimen preparation, master mix and reagents preparation, amplification, and product detection. The findings included: 1. The laboratory performed PCR testing for the presumptive detection of SARS-CoV-2 using the COVID-19 PCR True Mark 2 thermo-amplification kit and amplification method performed on the QuantStudio. 2. During the laboratory tour on February 15, 2022 at approximately 11:00 a.m. the surveyor observed that processing of the specimens, preparation of reagents, and sample template addition were all performed in the same open area without unidirectional flow. 3. The TS and TP confirmed by interview on 02/15/2022 that the laboratory's molecular PCR testing for the presumptive detection of SARS-CoV-2 RNA was not set up in a unidirectional flow area. 4. Based on laboratory records, the laboratory performed and reported approximately 634,922 SARS-CoV-2 Real Time PCR molecular diagnostic tests annually. D6083 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(2) 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 -- The laboratory director must ensure that the physical plant and environmental conditions of the laboratory are appropriate for the testing performed. This STANDARD is not met as evidenced by: Based on the surveyor's direct observations of the laboratory's SARS-CoV-2 PCR testing processes and interview with the laboratory's technical supervisor and testing personnel on February 15, 2022; the laboratory director failed to ensure that the physical plant and environmental conditions of the laboratory were appropriate for the testing performed. Findings include: See D3005. -- 2 of 2 --