Usa Biosciences, Llc

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on 06/06/2026 the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES D2016 - 42 C.F.R. 493.803 Condition: Successful [proficiency testing] participation; and D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) - 0155D and College of American Pathologists (CAP) records (2025-1 and 2025-3), the laboratory failed to successfully participate in a proficiency testing 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 -- program approved by HHS for each specialty, subspecialty and analyte or test in which the laboratory is certified under CLIA, the laboratory failed to successfully participate in the analyte: Bilirubin, Total, resulting in an unsuccessful performance. See D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and College of American Pathologists (CAP) report, the laboratory failed to achieve satisfactory performance for two of three consecutive events (2025-1 and 2025-3) for the analyte Bilirubin, Total (Bili, Total): Bili, Total 60% - 2025 first testing event; Bili, Total 20% - 2025 third testing event. A review of the 2025 scores from CAP confirmed the above findings. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155D report and CAP records for 2025-1 and 2025-3 events, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155D report and CAP records for 2025-1 and 2025-3 events, the laboratory director failed to ensure successful participation in an HHS proficiency testing program. Refer to D2096. -- 2 of 2 --

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 --