Atlantic Medical Oncology

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on August 29, 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] 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 an office review of the CASPER reports 153 and 155 and 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 -- provider reports, the laboratory failed to achieve 80% or more in two consecutive events for Routine Chemistry for the analyte Uric Acid (UA), with the College of American Pathologists (CAP). Cross refer to D2097. D2097 ROUTINE CHEMISTRY CFR(s): 493.841(g) (g) Failure to achieve an overall testing event score of satisfactory performance for 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 CASPER 155 report and graded results from the College of American Pathologists (CAP). The laboratory failed to achieve satisfactory performance (80% or greater) for two consecutive events in the subspecialty Routine Chemistry for the analyte Uric Acid (UA), resulting in initial unsuccessful performance. The findings include: 1) A review of the CASPER 155 report revealed the following. a) The laboratory scored 0% for UA in event 1-2025. b) The laboratory scored 0% for UA in event 2-2025. 2. A review of CAP graded results confirmed the laboratory failed two consecutive Proficiency Testing (PT) events. 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 review of the CASPER 155 report and graded results from the College of American Pathologists (CAP). The Laboratory Director (LD) failed to provide overall management and direction to laboratory personnel to ensure that the Proficiency Testing (PT) surveys are performed satisfactorily and in compliance with Clinical Laboratory Improvement Amendments (CLIA) regulations. The findings include: 1. The LD failed to ensure PT surveys are performed satisfactorily and in compliance with CLIA regulations. Cross 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 review of the CASPER 155 report and graded results from the College of American Pathologists (CAP), the Laboratory Director (LD) failed to ensure successful participation in a Department of Health and Human Services (DHHS) approved Proficiency Testing (PT) program for two consecutive PT events for the analyte Uric Acid (UA), resulting in initial unsuccessful performance. Cross refer to D2097. -- 2 of 2 --

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 surveyor review of the Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to review and evaluate PT results obtained from the College of American Pathologists (CAP) for Hematology tests from 3/1/25 to 7/30/25. The findings include: 1. Code 26 (educational challenge) results for Immature Granulocytes (IG) % and IG Absolute for PT event FH9-B-25 were not reviewed or evaluated. 2. TP #1 as listed on the CMS 209 form confirmed on 7/30/25 at 11:10 am, the laboratory did not review and evaluate all PT results obtained from CAP. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records, Procedure Manual (PM) and interview with the Testing Personnel (TP), the laboratory failed to verify the accuracy of all not graded results for PT events for Chemistry tests performed on the 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 -- Piccolo Abaxis analyzer with the American Proficiency Institute (API) from 3/1/24 to 7/30/25. The findings include: 1. Review of PT records revealed the laboratory received Not Graded scores from API for Total Bilirubin for the 1st Chemistry event of 2024. 2. There was no documented evidence the laboratory evaluated all Not Graded scores received from the PT provider. 3. TP #1 as listed on the CMS 209 form confirmed on 7/30/25 at 11:20 am, the laboratory failed to verify the accuracy of all Not Graded PT scores from API. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual and interview with Testing Personnel(TP), the laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems from 1/16/24 to 7/30/25. The finding includes: 1. The laboratory failed to have a procedure to verify new lots of controls before they were put in use on the Piccolo Abaxis. 2. The laboratory did verify new lots of QC, but did not have a detailed procedure to follow. 3. TP #1 as listed on the CMS-209 form confirmed on 7/30/25 at 10:40 am that the laboratory failed to have a procedure to verify new lots of controls before they were put in use. -- 2 of 2 --

Summary Statement of Deficiencies D5783

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 surveyor review of Proficiency Testing (PT) and interview with the Testing Personnel (TP), the laboratory failed to achieve a score of 80% or more for Hematology tests performed with the American Proficiency Institute (API). The finding includes: 1) The laboratory scored 20% for Lymphocytes % event 2-2021 with the API. 2) The laboratory scored 60% for Lymphocytes % event 1-2021 with the API. 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 6 -- 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 surveyor review of Proficiency Testing (PT) and interview with the Testing Personnel (TP), the laboratory failed to achieve a score of 80% or more in two out of three events for for Hematology tests performed with the American Proficiency Institute (API). The findings include: 1) The laboratory scored 20% for Lymphocytes % event 2-2021 with the API. 2) The laboratory scored 60% for Lymphocytes % event 1-2021 with the API. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM), and interview with the Testing Personnel (TP), the laboratory failed to follow procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems from January 2021 to the date of the survey. The findings include: 1. The laboratory failed to follow the PM for supervisor review of Quality Control (QC) reports on the Sysmex XN-550 analyzer. 2. The PM stated "The supervisor reviews the following QC reports at the following intervals": a. Insight IQAP every month or applicable. b. Exception Report every month or applicable. c. Summary Report every month or applicable. d. Detailed Daily Verification report every month or applicable. e. Parameter Report every month or applicable. 3. There was no documented evidence the laboratory performed the aforementioned procedures. 4. The TP#1 listed on CMS form 209 confirmed 10/13/21 at 12:00 pm that the laboratory failed to follow procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on the lack of the Maintenance Records (MR) and interview with the Tetsing Personnl (TP), the laboratory failed to perform and document preventative maintenance as specified by the manufacturer on the Sysmex XN-550 used for -- 2 of 6 -- Hematology tests from January 2021 to the date of the survey. The TP #1 listed on CMS form 209 confirmed on 10/13/21 at 12:15 pm that preventative maintenance as specified by the manufacturer was not performed. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on surveyor review of Calibration Verification (CV) records, Procedure Manual (PM) and interview with the Testing Personnel (TP), the laboratory failed to perform and document Calibration procedures at least once every six months for Hematology Tests performed on the Sysmex XN-550 analyzer from 12/18/21 to the date of the survey. The findings include: 1. A review of CV records revealed that the laboratory did not perform "Precision Check" as requireed prior to CV. 2. A review of CV records revealed CV was not run every six months. 3. The TP #1 of CMS form 209 confirmed on 10/13/21 at 10:30 am that the laboratory failed to perform and document CV. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of Quality Control (QC) records and interview with the Testing Personnel (TP), the laboratory failed to have available defined statistical parameters of commercially assayed Hematology QC material with each new lot and /or shipment used on the Sysmex XN-550 analyzer from January 2021 to date of survey. The findings include: 1. XN- Control lot 11831401, 11831402, 11831403 had -- 3 of 6 -- no Manufacturers Package Insert with QC values prior to running QC to verify if the QC was in range prior to putting them in use. 2. The TP#1 listed on CMS form 209 confirmed on 10/13/21 at 11:00 am that all assayed QC material was not verified before putting in use. D5779

Summary Statement of Deficiencies D2121 HEMATOLOGY CFR(s): 493.851(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 surveyor review of the Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to the laboratory failed to attain at least 80% or more for Hematology/coagulation performed with the American Proficiency Institute (API) for event 2-2017. The findings include: 1. The laboratory received a grade of 0% white blood cell differential all analytes. 2. The laboratory received a 60% for MCHC. 3. The