Atlantic Oncology Associates, Llc

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Office Manager (OM), the laboratory failed to ensure that all Testing Personnel (TP) who performed Hematology tests participated in the AAB Medical Laboratory Evaluation (AAB MLE) Non Chemistry PT events in the calendar year 2024. The findings include: 1. A review of all three AAB MLE PT events in 2024 revealed that one out of four TP that were employed during 2024, performed PT for all three events in 2024. The TP that performed all three events is no longer employed and therefore not on the CMS-209. 2. The OM confirmed on 5/8/25 at 11:00 am that PT events were not rotated between TP in 2024. 3. Note: this deficiency was also cited during the 3/19 /24 survey. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (b)(7) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on the surveyor review of the Proficiency Testing (PT) records and AAB Medical Laboratory Evaluation (AAB MLE) attestation statement sheets and 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 -- interview with the Office Manager (OM), the laboratory failed to ensure tha signed attestation statements were maintained from 3/19/24 to 5/8/25. The findings include: 1. Attestation sheets were not signed by the testing personnel (TP) and the Laboratory Director (LD) for all of the AAB MLE Non-Chemistry, Hematology surveys for all three events in 2024 and the first event of 2025 . 2. The OM confirmed on 5/8/25 at 11:15 am that the attestation statements for 2024 and the first event of 2025 were not signed by the TP and LD. 3. Note: this deficiency was also cited during the 3/19/24 survey. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on surveyor review of the "Procedure for Handling Abnormal Results" (PHAR), patient work records (WR) and test reports (TR) and interview with the Office Manager (OM), the laboratory failed to follow the procedure to verify abnormal automated differential results from 3/19/24 to 5/8/25. The findings include: 1. The PHAR states "Abnormal electronic differential results, ie those with incomplete results, region flags and/or abnormal distribution should be verified." 2. Five out of five flagged differential results reviewed had no verification performed and /or documented: a. ID 9680, 6/11/24, R flags and Messages b. ID 1029, 6/11/24, R flags and Messages c. ID 830, 9/18/24, Message d. ID 13363, 9/18/24, R flags and Messages e. ID 13156, 11/20/24, R flags and Messages 3. The OM confirmed on 5/8 /25 at 1:00 pm that the laboratory failed to follow the PHAR. 4. Note: this deficiency was also cited during the 3/19/24 survey. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) (e)(11) Ensure that prior to testing patients specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results; This STANDARD is not met as evidenced by: Based on surveyor review of Laboratory Personnel (LP) files and interview with the Office Manager (OM), the Laboratory Director (LD) failed to ensure that the laboratory had all education records from 3/19/24 to 5/8/25. The findings include: 1. There was no associate's degree in the personnel records for Testing Personnel #1 (TP #1) provided on the CMS-209 form. 2. The OM confirmed on 5/8/25 at 10:30 am, the LD failed to ensure the LP files had all education records. -- 2 of 2 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Office Manager (OM), the laboratory failed to ensure that all Testing Personnel (TP) who performed Hematology tests participated in the AAB Medical Laboratory Evaluation PT events in the calendar year 2023. The finding includes: 1. A review of all PT events revealed that one out of two TP, TP #2 as provided on the survey CMS- 209, performed PT for all three events in 2023. 2. The OM confirmed on 3/19/23 at 11: 00 pm that PT events were not rotated between TP in 2023. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- This STANDARD is not met as evidenced by: Based on the surveyor review of the Proficiency Testing (PT) records and the lack of attestation statements and interview with the Office Manager (OM), the laboratory failed to ensure that attestation statements signed by the testing personnel (TP) and the Laboratory Director (LD) were provided for all of the AAB Medical Laboratory Evaluation Non-Chemistry, Hematology surveys in calendar year 2023 . The OM confirmed on 3/19/24 at 11:15 am that the attestation statements for the M1 and M2 events were not signed by the TP and LD. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Office Manager (OM), the Laboratory Director failed to ensure that they reviewed and signed all AAB Medical Laboratory Evaluation graded results for the 2023 surveys. The OM confirmed on 3/19/24 at 11:30 am that the laboratory director did not review and sign the graded results for the Non-Chemistry, Hematology M1 and M2 2023 surveys. 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 surveyor review of the Proficiency Testing (PT) records and interview with Office Manager (OM), the laboratory failed to document the evaluation of all incorrect scores and

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 an office review of the CASPER reports 153 and 155 and Proficiency Testing (PT) provider reports, the laboratory failed to achieve a score of 80% or more for Hematology tests performed with the American College of Physicians, Medical Laboratory Evaluation (MLE). The finding includes: 1) The laboratory scored a 60% for Hematocrit and Erythrocyte count in event 1-21 and 2-21 with the MLE. 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 an office review of the proficecny testing provider reports and CASPER reports 153 and 155 and Proficiency Testing (PT), the laboratory failed to achieve a score of 80% or more in two out of three event for for Hematology tests performed with the American College of Physicians, Medical Laboratory Evaluation (MLE). The findings include: 1) The laboratory scored a 60% for Hematocrit and Erythrocyte count in event 1-21 and 2-21 with the MLE. 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 an office review of the laboratory's performance in Proficiency Testing (PT) surveys, the Laboratory Director failed to provide appropriate direction to the laboratory personnel to ensure that the PT surveys were performed satisfactorily and compliance with the CLIA regulations are maintained. -- 2 of 2 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on the review of Competency Assessment (CA) records and interview with the Testing Personnel (TP), the laboratory failed to perform a CA on two out of five testing personnel for the calendar year 2018 to the date of survey. The TP #1 listed on CMS form 209 confirmed on 12/19/19 at 11:00 am that the CA was not performed as stated above. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) 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)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on surveyor review of the Performance Specification (PS) records and interview with the Testing Personnel (TP), the Laboratory Director (LD) failed to 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 -- ensure that PS procedures for Hematology tests performed on the Beckman Coulter Act2 analyzer were adequate from March 2018 to the date of survey. The findings include: 1. There was no evidence documented that accuracy or precision was performed. 2. There was no documented evidence that the LD approved the PS. 3. The TP #1 listed on CMS form 209 confirmed on 12/19/19 at 11:15 am that PS records were not adequate. -- 2 of 2 --