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 Polymerase Chain Reaction (PCR) testing for the presumptive detection of SARS CoV-2 (COVID19), Influenza A and B, and Respiratory Syncytial Virus (RSV) RNA and interviews with the laboratory's technical supervisor (TS) and testing personnel (TP) on October 12, 2023 on its molecular amplification procedure; it was determined that the laboratory failed to ensure that the PCR 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 detection of COVID19, Influenza and RSV RNA detection using manual methods for preparation of the master-mixes, controls and reagents, and addition of template. 2. During the laboratory tour on October 12, 2023, at approximately 3:30 p.m. the surveyor observed that processing of the specimens, preparation of reagents, and sample template addition were all performed in the same room/area without unidirectional flow. 3. The TS and TP confirmed by interview that the laboratory's molecular PCR testing was not set up in a unidirectional flow area. 4. Based on laboratory records, the laboratory performed and reported approximately 900 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 surveyors' direct observations of the laboratory's SARS- CoV-2 (COVID19), Influenza A and B, and Respiratory Syncytial Virus (RSV) RNA detection testing processes and interview with the laboratory technical supervisor and testing personnel on October 12, 2023; the laboratory director failed to ensure that the physical plant to conduct polymerase chain reaction (PCR) testing of the laboratory is appropriate. Findings include See D3005. -- 2 of 2 --