Care Oncology Center

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 director (DL) on November 25, 2025, it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for Hematology for each analyte in 2023,2024 and 2025. The findings included: 1.The laboratory performed Complete Blood Count (CBC) test using Horiba ABX Pentra 60 C. The laboratory participated in the AAB proficiency testing program for Hematology testing. According to the AAB evaluation, the laboratory attained the following unsatisfactory scores: M3- 2023: Erythrocytes (RBC) = 40% M3- 2023: Platelets= 60% M2- 2024: Basophil %= 0% M2- 2024: Neutrophil %= 0% M3- 2024: Basophil %=40% M2- 2025: Neutrophil %= 0% 2. On November 25, 2025, at approximately 9:30 am, the laboratory director affirmed that the laboratory received the above unsatisfactory proficiency scores. 3. The laboratory's testing declaration form, signed by the laboratory director on November 13, 2025, stated that the laboratory performed approximately 3120 hematology tests annually. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. In addition, 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 -- retain the following: This STANDARD is not met as evidenced by: Based on review of the laboratory's quality control records (QC), and interview with the laboratory personnel on November 25, 2025, it was determined that the laboratory failed to retain quality control documentation in 2023, 2024 and 2025. The findings included: 1.The laboratory performed hematology testing using Horiba ABX Pentra 60 C. Laboratory did not retain instrument records for QC for hematology tests prior to September 2025. 2. On November 25, 2025, at approximately 10:30 am, the laboratory staff affirmed that the laboratory did not print the QC reports and instrument did not save the previous results. 3. The laboratory's testing declaration form, signed by the laboratory director on November 13, 2025, stated that the laboratory performed approximately 3120 hematology tests annually. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on interview with laboratory staff and review of proficiency testing and quality control records on November 25, 2025, the laboratory director (LD) failed to provide overall management and direction in accordance with 493.1445 of this subpart. The findings included: 1-The LD failed to ensure the proficiency testing samples were tested as required under subpart H of 42 CFR 493. See D2121 2- The LD failed to ensure that quality control records were retained for the past two years. See D3031 -- 2 of 2 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on 12/19/2024, 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]; 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 Certificate and Survey Provider Enhanced Reporting (CASPER) - 0155D and PT program records (for proficinecy testing events: 2024-2 and 2024-3), the laboratory failed to successfully participate in a AAB-Medical 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 -- Laboratory Evaluation 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 an Hematology test (Cell ID), resulting in an unsuccessful performance. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and AAB-Medical Laboratory Evaluation report, the laboratory failed to achieve satisfactory performance for two consecutive proficiency testing events (2024: second event & third testing events) for the Hematology - analyte Cell ID: The findings include: Cell ID - 2024 second testing event, laboratory scored 76%, Cell ID - 2024 third testing event, laboratory scored 68%. AAB-Medical Laboratory Evaluation 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 AAB- Medical Laboratory Evaluation program records for 2024-2 and 2024-3 proficiency 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) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that 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 AAB- Medical Laboratory Evaluation program records for 2024-2 and 2024-3 events, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2130. -- 2 of 2 --