Patrick J Dipaolo Md

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 Proficiency Institute (API). The finding includes: 1) The laboratory scored 40% for Erythrocyte Count, 40% for Hematocrit, 40% for Mean Corpuscular Hemoglobin (MCH), 40% for Mean Corpuscular Hemoglobin Concentration (MCHC), 20% for Mean Corpuscular Volume (MCV), 40% for Red Cell Distribution Width (RDW), 60% for Lymphocytes 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 -- in event 3-2021 with the API. 2) The laboratory scored 40% for HCT, 40% for MCH, 0% for MCHC, 60% for MCV, 40% for RDW, 60% for Lymphs in event 2-2022 with the API. 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 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 40% for Erythrocyte Count, 40% for Hematocrit, 40% for Mean Corpuscular Hemoglobin (MCH), 40% for Mean Corpuscular Hemoglobin Concentration (MCHC), 20% for Mean Corpuscular Volume (MCV), 40% for Red Cell Distribution Width (RDW), 60% for Lymphocytes in event 3-2021 with the API. 2) The laboratory scored 40% for HCT, 40% for MCH, 0% for MCHC, 60% for MCV, 40% for RDW, 60% for Lymphs in event 2-2022 with the API. 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 are 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 lack of Competency Assessment (CA) records and interview with the Office Manager (OM), the laboratory failed to follow the CA procedure on one of one Testing Personnel for the calendar years 2019 and 2020. The OM confirmed on 6/29 /21 at 9:40 am that the CA procedure was not followed as stated above. 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 Office Manager (OM), the laboratory failed to review and evaluate results when they received an unacceptable score in Hematology tests performed with the American Proficiency Institute (API) for the third event in the calendar year 2019. The findings include: 1. The laboratory received an 40% Grade for Mean Corpuscular Hemoglobin (MCH) 2. The laboratory received a 60% Grade for Mean Corpuscular Volume (MCV) 3. There was no documented evidence that the laboratory investigated the failures. 4. The OM confirmed on 6/29/21 at 10:45 am that the laboratory did not review and document an evaluation of unacceptable PT results. 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 -- D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies 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. 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 maintain the Work Records (WR) and Attestation Statements (AS) signed by the analyst and Laboratory Director for Hematology tests performed with the American Proficiency Institute for events in the calendar years 2018 and 2019. The findings include: 1. The WR and AS were not maintained for the 1-2018, 3-2018 and 1-2019 events. 2. The TP confirmed on 5/9/19 at 10:00 am that AS and WR were not maintained. 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. 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 -- This STANDARD is not met as evidenced by: a. Based on surveyor review of the Competency Assessment (CA) records and interview with the Testing Personnel (TP), the laboratory failed to evaluate competency accurately on one of one TP on 5/4/19. The findings include: 1. The laboratory failed to use the CA evaluation tools accurately as follows: a. Monitoring the recording and reporting of test results, Quality Control (QC), Proficiency Test (PT) performance and preventative maintenance logs was used to assess: 1. Specimens processed and stored in a timely manner. 2. Testing material stored and handled correctly. 3. Observation of all phases of testing. 4. Instrument maintenance and function checks. 5. The TP contacts appropriate person when questions arise b. Direct observation of performance of instrument maintenance and function checks was used to assess: 1. Specimens processed and stored in a timely manner. 2. Testing material stored and handled correctly. 3. Observation of all phases of testing. 4. Patient tests reported according to protocol. 5. The TP recognizes all system failures, unacceptable QC and calibrations and erroneous test results. 6. The TP contacts appropriate person when questions arise. c. Assessment of test performance through blind patient samples or PT was used to assess: 1. When problems arise the TP knows how to assess the problem and does what is required. 2. The TP documents all corrective plan of actions associated with QC, instrument maintenance and PT. 3. The TP contacts appropriate person when questions arise 2. The TP stated on 5/9/19 at 10: 30 am the laboratory did not uses the CA evaluation tools accurately. b. Based on review of the CA records, review of the personnel files and interview with the TP, the laboratory failed to perform a CA on one of one TP in the calendar years 2017 and 2018. The TP confirmed on 5/9/19 at 10:20 am that CA was not performed annually. Note: These citations were cited on previous survey performed 2/2/17