Shield T3 Llc

Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on the number and severity of the deficiencies cited herein, the Condition: Facility Administration was not met. The findings include: 1. The laboratory failed to have adequate space necessary for conducting specimen receiving, accessioning, and processing (preanalytic), preparation of positive controls, addition of sample template, and polymerase chain reaction (PCR) testing (analytic) and analysis and interpretation of test results (postanalytic). See D3001. 2. The laboratory failed to ensure contamination of patient specimens, equipment, instruments, reagents, materials, and supplies was minimized. See D3003. 3. The laboratory failed to ensure that the molecular amplification procedures that are not contained in closed systems have unidirectional flow for specimen preparation, reagent preparation, RNA extraction, amplification, and RNA detection. See D3005. D3001 FACILITIES CFR(s): 493.1101(a)(1) The laboratory must be constructed, arranged, and maintained to ensure the space, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- ventilation, and utilities necessary for conducting all phases of the testing process. This STANDARD is not met as evidenced by: Based on observation of the laboratory testing area (one trailer with external refrigerated air supply) and interview with the technical supervisor (TS), general supervisor (GS), and testing personnel (TP); it was determined that the laboratory testing area failed to provide adequate space, ventilation, and utilities necessary for conducting all phases of the clinical testing process. The findings included: 1. The laboratory area consist of a trailer of approximately 700 square feet in which specimen receiving, sample processing, preparation of reagents and controls, addition of sample template, reading, and analyzing of test results for the detection of SARS- CoV-2 by the polymerase chain reaction (PCR) took place. 2. The space for the testing personnel (about 6 TP), biosafety cabinets, PCR processing sections, and PCR testing equipment (3 Quant Studio instruments) is very limited and all sections are next to each other . The testing area is crowded where TP bump into each other, it is difficult to maintain, and fail to provide sample integrity and quality of testing. In addition, the proximity of testing areas increases the risk of sample cross contamination. 3. The TS, GS, TP affirmed on April 12, 2021 at approximately 11:00 a.m. that the laboratory testing space , fails to provide adequate working areas, ventilation, and utilities for conducting all phases of the testing process: preanalytical, analytical and postanalytical. 4. The laboratory's testing declaration form, signed by the laboratory director on April 12, 2021, stated that the laboratory performs approximately 750,000 tests annually. D3003 FACILITIES CFR(s): 493.1101(a)(2) The laboratory must be constructed, arranged, and maintained to ensure contamination of patient specimens, equipment, instruments, reagents, materials, and supplies is minimized. This STANDARD is not met as evidenced by: Based on surveyor observation during the laboratory tour and interview the technical supervisor (TS) and general supervisor (GS) on April 12, 2021; it was determined that the laboratory failed to minimize contamination of patient specimens, equipment, and materials used during specimen receiving and processing. Findings include: 1. During the laboratory tour at approximately 11:00 a.m. the surveyor observed the area assigned for sample receiving and processing to be a very restricted area. The samples were received through a small window where the following took place: a. The TP receiving the specimens tore the biohazard bag open containing a tube with raw saliva sample in an opened bench. b. The biohazard bag was not decontaminated before or after removal of the tube containing the sample. c. Samples were then placed in a glass container with 3% hydrogen peroxide (H2O2) on the same opened bench where specimen receiving took place. d. There was no record of when or how the H2O2 was prepared. e. No change of gloves was observed when transferring samples to the heated water bath for deactivation. 2. Preparation of the master mix, positive controls, and addition of sample template took place in the same Biosafety Cabinet (BSC): a. Even though there was a decontamination log, the surveyor observed transferring of samples and code scanning samples continously disturbing the laminar flow in the BSC. b. Change of gloves did not take place between addition of template from one plate to another. 3. During an interview on April 12, 2021 at approximately 11:45 p. -- 2 of 9 -- m. the TS and GS confirmed the laboratory failed to minimize contamination of patient specimens, equipment, instruments, reagents, materials, and supplies when processing in both an opened bench and under the BSC. 4. The laboratory's testing declaration form, signed by the laboratory director on April 12, 2021stated that the laboratory performs 750,000 tests annually during two 10 hours shifts Monday through Friday . 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 detection by the Polymerase Chain Reaction (PCR) testing, and interviews with the technical supervisor (TS), general supervisor (GS) and testing personnel (TP) on April 12, 2021 for its molecular amplification procedure; it was determined that the laboratory failed to ensure that the molecular amplification procedures that are not contained in closed systems have unidirectional flow for specimen preparation, reagent preparation, RNA extraction, amplification, and RNA detection. The findings included: 1. The laboratory performs PCR testing for the presumptive detection of SARS-CoV-2 in saliva using the covidSHIELD a modification of the EUA Thermo Fisher Scientific Applied Biosystems TaqPath COVID-19 Combo Kit. 2. During the laboratory tour on 04/12/2021 at approximately 11:00 a.m. the surveyor observed that storage and preparation of reagents, RNA extraction, and PCR reaction using the QuantStudio were all performed in the same room with no unidirectional flow. In addition, preparation of reagents for the PCR Master Mix cocktail, positive control, and addition of sample template were performed under the same Biosafety cabinet. 3. The TS, GS, and TP confirmed by interview on April 12,2021 at approximately 11:45 a.m. that the laboratory's molecular PCR testing for the presumptive detection of SARS-CoV-2 RNA was not set up in separate areas with unidirectional flow rooms. 4. Based on laboratory records, the laboratory performed and reported approximately 750,000 Virology (COVID-19) molecular diagnostic tests annually. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of a proficiency testing report, lack of documentation for corrected action, and interview with the laboratory's general supervisor (GS), it was determined that the laboratory failed to document