Robert M Goldberg Md Pa

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on July 16, 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 out of three events for Hematology for the analyte Red Blood cell Count (RBC) with the American Association of Bioanalysts (AAB). 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 review of the CASPER 155 report and graded results from American Association of Bioanalysts (AAB). The laboratory failed to achieve satisfactory performance (80% or greater) for two consecutive events in the subspecialty Hematology for the analyte Red Blood cell Count (RBC) resulting in initial unsuccessful performance. The findings include: 1) A review of the CASPER 155 report revealed the following. a) The laboratory scored 20% for RBC in event 1-2025. b) The laboratory scored 0% for RBC in event 2-2025. 2. A review of AAB 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 American Association of Bioanalysts (AAB), 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 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 Association of Bioanalysts (AAB), 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 Red Blood cell Count (RBC), resulting in initial unsuccessful performance. Refer to D2130. -- 2 of 2 --

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 laboratory director (LD), the laboratory failed to ensure that all Testing Personnel (TP) who performed Hematology testing participated in the American Association of Bioanalysts Medical Laboratory Evaluation (AAB/MLE) PT surveys in the calendar years 2024 and 2025. The finding includes: 1. A review of AAB/MLE PT records revealed that the LD performed PT for all three events in 2024 and the 1st event of 2025. 2. The LD confirmed on 6/9/25 at 11:25 am that PT events were not rotated between all TP provided on the CMS-209 during the survey in the 2024 and 2025 calendar years. 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 lack of Competency Assessment (CA) records and interview with the Laboratory Director (LD), the laboratory failed to perform a CA on two out of two testing personnel (TP) for the calendar years 2023, 2024 and 2025 (if due). 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 3 -- findings include: 1. Two out of two TP, provided on the CMS-209 during the survey, had no CA documentation provided. 2. The LD confirmed on 6/9/25 at 11:00 am that the CA was not performed as stated above. 3. Note: this deficiency was also cited during the 7/25/23 survey. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I 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 Laboratory Director (LD), the laboratory failed to verify the accuracy and reliability of all Hematology testing analytes performed on the Beckman Coulter DxH 500 from 7/25/23 to 6/9/25. The finding includes: 1. Surveyor review of PT records revealed all Hematology analytes tested by the laboratory were not included in PT events 1, 2 and 3 in 2023 and 2024 and PT event 1 in 2025 performed with PT provider American Association of Bioanalysts Medical Laboratory Evaluation (AAB /MLE). 2. The following analytes were not verified for accuracy twice annually on the Beckamn Coulter DxH 500 analyzer: a) Mean Corpuscular Hemoglobin (MCH) b) Mean Corpuscular Hemoglobin Concentration (MCHC) c Mean Corpuscular Volume (MCV) d) Red Cell Width (RDW 3. The LD confirmed 6/9/25 at at 11:00 am, the laboratory did not verify the accuracy of all analytes performed on the Beckman Coulter DxH 500. 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 the Laboratory Director (LD), the laboratory failed to document the evaluation of all unsatisfactory PT scores and

Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on an in-office review of the laboratory's requirements for a New Jersey State Clinical Laboratory License (NJCLL) under New Jersey Statutes Annotated: N.J.S.A. 45:9-42.28. License; necessity; categories, the laboratory failed to maintain a NJCLL for 2023. The Program Manager for the Clinical Laboratory Improvement Services (CLIS) confirmed on 7/24/23, prior to the recertification survey, that the laboratory did not have a NJCLL license for 2023 or any prior years. The Laboratory Director confirmed on 7/25/23 at 12:30 pm that the laboratory did not maintain a NJCLL for 2023 or any prior years. 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 lack of Competency Assessment (CA) records and interview with the Laboratory Director (LD), the laboratory failed to perform a CA on two out of two testing personnel for the calendar years 2021, 2022 and 2023. The LD confirmed on 7 /25/23 at 10:30 am that the CA was not performed as stated above. 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 -- D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on surveyor review of patient work records, review of the Beckman Coulter AcT diff 2 Operator's Guide (OG) and interview with the Laboratory Director (LD), the laboratory failed to follow the OG for the Hematology testing performed on the Beckman Coulter AcT diff 2 from 5/18/21 to the date of survey. The findings include: 1. 6 out of 10 patient work records had flags but there was no

Summary Statement of Deficiencies 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, Operators Manual (OM) and interview with the Laboratory Director (LD), the laboratory failed to perform and document Calibration procedures at least once every six months for Hematology Tests performed on the Beckman Coulter Act2 analyzer used for Hematology tests from February 2021 to the date of the survey. The findings include: 1. A review of CV records reviled that the laboratory runs CV in February and August of each year. 2. A review of CV records revealed that last time CV was performed was August 2020. 3. The LD confirmed on 5/18/21 at 11:30 am that the laboratory failed to perform and document CV in February 2021. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5783