Los Angeles Hematology Oncology

Summary Statement of Deficiencies D2121 HEMATOLOGY CFR(s): 493.851(a) (a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of the AAB-MEDICAL LABORATORY EVALUATION proficiency testing (PT) records, and interview with the laboratory technical consultant (TC) on March 03, 2026, it was determined that the laboratory failed to attain a score of at least of 80 percent of acceptable responses for the analyte Red Blood Cell (RBC) count for the first PT event of 2025. The findings included: 1. The laboratory enrolled in the AAB-MEDICAL LABORATORY EVALUATION proficiency testing program for Hematology testing using Abbott Cell-Dye 1800 analyzer. According to the PT evaluation report, the laboratory attained an unsatisfactory score of 40% for RBC count in first PT event of 2025. 2. On March 3, 2026, at approximately 11:30 am, the laboratory technical consultant affirmed that the laboratory received the above unsatisfactory proficiency scores. 3. The laboratory's testing declaration form, signed by the laboratory director on March 2, 2026, stated that the laboratory performed approximately 10,400 hematology tests including RBC annually. D2123 HEMATOLOGY CFR(s): 493.851(c) (c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (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 notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on review of the AAB-MEDICAL LABORATORY EVALUATION proficiency testing (PT) records, and an interview with the laboratory technical consultant (TC) on March 03, 2026, it was determined that the laboratory failed to participate in the third testing event of 2024 for the specialty of Hematology. The findings included: 1. The laboratory enrolled in the AAB-MEDICAL LABORATORY EVALUATION proficiency testing program for Hematology testing using Abbott Cell-Dye 1800 analyzer. According to the PT evaluation report, the laboratory attained score of 0 % in Hematology in the third testing event of 2024. 2. On March 3, 2026, at approximately 11:30 am, the laboratory technical consultant affirmed that the laboratory received the above unsatisfactory proficiency scores. 3. The laboratory's testing declaration form, signed by the laboratory director on March 2, 2026, stated that the laboratory performed approximately 10,400 hematology tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on 04/23/2025, the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing]; and D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director. 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 AAB - Medical Laboratory Evaluation (AAB) report (for proficiency testing events: 2024-3 and 2025-1), the laboratory failed to successfully 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 -- participate in a proficiency testing 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 for the analyte - RBC, resulting in a unsuccessful performance. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) (f) 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 desk review of Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and AAB - Medical Laboratory Evaluation (AAB) report (for proficiency testing events: 2024-3 and 2025- 1), the laboratory failed to achieve satisfactory performance for two of three consecutive proficiency events in 2024 and 2025, for the analyte - RBC. The finding include: 2024 third event, RBC - 0%, 2025 first event, RBC - 40%. A review of the 2023 and 2024 proficiency testing scores from AAB 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 Certification and Survey Provider Enhanced Reporting (CASPER) - 0155D report AAB proficiency testing records for 2024-3 and 2025-1 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 Certification and Survey Provider Enhanced Reporting (CASPER) - 0155D report AAB proficiency testing records for 2024-3 and 2025-1 events, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2130. -- 2 of 2 --