C A R E S Oxford

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of the American Association of Bioanalysts-Medical Laboratory Evaluation (AAB-MLE) Proficiency Testing (PT) records and an interview with Testing Personnel 4 (TP4), the laboratory failed to document review and evaluation of PT performance by the Laboratory Director (or designee). This was noted for 12 of the 12 events reviewed in 2024-2025. The findings include: 1. A review of the AAB- MLE PT records revealed no documentation of review on the graded evaluations by the Laboratory Director, or designee, for the following events: a) 2024 Chemistry M1- M3 Events b) 2024 Hematology M1-M3 Events c) 2025 Chemistry M1-M3 Events d) 2025 Hematology M1-M3 Events 2. TP4 confirmed the above findings during the exit conference on 02-24-2026 at 1:30 PM. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually This STANDARD is not met as evidenced by: Based on a review of the annual competency assessment records and an interview with the Testing Personnel 4 (TP4), the Technical Consultant (TC) failed to assess and document the annual competency assessments for TP who performed microscopy examinations. The surveyor noted five of the five TP listed on the CMS-209 (Laboratory Personnel Report) had no documentation of the annual competency in 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 -- 2024-2025. The findings include: 1. A review of personnel evaluation records revealed the TC did not document the 2024 and 2025 annual competency assessments for TP1-TP5 who performed microscopy examinations in the Urine Sediments and Vaginal Wet Preparations. 2. During the exit conference on 02-24-2026 at 1:30 PM, the TP4 confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies 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 a review of the Centers for Medicare and Medicaid Services (CMS) CASPER reports and interviews with the testing personnel, the laboratory failed to successfully participate in proficiency testing (PT) for White Blood Cell (WBC) Differential for two of three testing events, Event #2, 2022 and Event #1, 2023. These failures result in an initial unsuccessful PT Participation. The findings include: Refer to D2130 D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services (CMS) CASPER reports and interviews with the testing personnel, the laboratory failed to satisfactorily perform in proficiency testing (PT) for White Blood Cell (WBC) Differential for two of three testing events, Event #2, 2022 and Event #1, 2023. The findings include: 1. A review of the CMS CASPER report revealed the laboratory scored the following: a) Event #2, 2022 WBC Differential = zero percent (0 %) b) Event #3, 2023 WBC Differential = 67 % 2. In an interview on 6/23/2023 at 12:48 PM, the testing personnel stated the books (proficiency testing books) were at the other location, and she would review the books and contact the State Agency, regarding the proficiency testing. In an interview on 6/26/2023 at 1:12 PM, the testing personnel stated the failures for both events (Event #2, 2022 and Event #1, 2023) were due to clerical errors. -- 2 of 2 --