Goldberg & Pellegrini Md, Pc

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 Proficiency Test (PT) desk review of the Center for Medicaid & Medicare Services (CMS) PT data reports and PT summary reports from American Proficiency Institute (API) PT program, the laboratory failed to participate successfully in CMS approved proficiency testing program, for the speciality Endocrinology and the test analyte's Triiodothyronine (T3) and Thyroxine (T4). The following scores were assigned: Speciality Endocrinology 2023 first event = 60% 2023 second event = 50% T4 2023 first event = 40% 2023 second event = 0% T3 2023 first event = 0% 2023 second event = 0% This is considered unsuccessful PT performance. Refer to D2107 and D2108 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 -- D2107 ENDOCRINOLOGY CFR(s): 493.843(f) Failure to achieve satisfactory performance for the same analyte or test in 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 PT desk review of the CMS PT data reports and PT summary reports from API PT program, the laboratory failed to participate successfully in CMS approved proficiency testing program, for the test analyte's Triiodothyronine (T3) and Thyroxine (T4). The following scores were assigned: T4 2023 first event = 40% 2023 second event = 0% T3 2023 first event = 0% 2023 second event = 0% This is considered unsuccessful PT performance. D2108 ENDOCRINOLOGY CFR(s): 493.843(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 PT desk review of the CMS PT data reports and PT summary reports from API PT program, the laboratory failed to participate successfully in CMS approved proficiency testing program, for the speciality Endocrinology. The following scores were assigned: speciality Endocrinology 2023 first event = 60% 2023 second event = 50% This is considered unsuccessful PT performance. 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 PT desk review of the CMS PT and API PT program records, the laboratory director failed to fulfill the laboratory director's responsibilities and ensure that the laboratory achieved a satisfactory performance and successfully participate in a PT program, approved by CMS, for the speciality for the speciality Endocrinology and the test analyte's Triiodothyronine (T3) and Thyroxine (T4). 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 -- 2 of 3 -- 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 PT desk review of the CMS PT and API PT program records, the laboratory director failed to fulfill the laboratory director's responsibilities and ensure that the laboratory achieved a satisfactory performance and successfully participate in a PT program, approved by CMS, for the speciality for the speciality Endocrinology and the test analyte's Triiodothyronine (T3) and Thyroxine (T4). The following scores were assigned: Speciality Endocrinology 2023 first event = 60% 2023 second event = 50% T4 2023 first event = 40% 2023 second event = 0% T3 2023 first event = 0% 2023 second event = 0% This is considered unsuccessful PT performance. -- 3 of 3 --

Summary Statement of Deficiencies D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on of the laboratory's calibration and verification procedures, lack of calibration verification documentation, and an interview with the testing person, the laboratory failed to perform the Alfa Wasserman ACE chemistry analyzer six-month calibration verification due on January 1, 2021. FINDINGS: 1. The laboratory's calibration verification procedure required calibration verification to be performed for test analytes that have less than three point calibrator. It was noted that the Gemcal 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 -- one point calibrator was performed on the chemistry analyzer however calibration verification was required every six-months. 2. The laboratory failed to perform calibration verification from 3/5/2022 through 4/24/2023. It was noted that calibration verification was performed from 2/5/2021 and 4/24/2023. Approximately 200 patients were tested from 3/5/2022 through 4/24/2023. 3. The laboratory testing person confirmed on April 26, 2023, at approximately 3:30 P.M. that the laboratory failed to perform the Alfa Wasserman ACE chemistry analyzer six-month calibration verification for 3/5/2022 through 4/24/2023. Refer to D6000 and D6020. THIS IS A RECITED STANDARD DEFICIENCY FROM THE SURVEY CONDUCTED ON JULY 13, 2021 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 laboratory's calibration verification procedure and confirmed in an interview with the testing person, the director failed to provide overall management for all phases of moderate complexity testing. FINDINGS: The laboratory director failed to ensure that the laboratory: 1. Implemented and maintained the

Summary Statement of Deficiencies 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 surveyor's review of laboratory's equipment maintenance procedures, lack of maintenance records for the Alfa Wasserman Ace chemistry, Beckman Coulter AcT Diff hematology, Beckman Access 2 endocrinology analyzers and an interview with the testing person, the laboratory failed to follow the manufacturer's requirements and the laboratory's maintenance procedures for the analyzers from January 1, 2021 through July 13, 2021. FINDINGS: 1. The testing person confirmed on July 13, 2021 at approximately 10:00 AM, the laboratory failed to follow the manufacturer's requirements and the laboratory's maintenance procedures for the Alfa Wasserman Ace chemistry, Beckman Coulter AcT Diff hematology, Beckman Access 2 endocrinology analyzers from January 1, 2021 through July 13, 2021. a. The laboratory failed to perform the weekly, monthly and quarterly maintenance as required. 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, 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 -- 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's review of Beckman Coulter AcT Diff hematology analyzer records and an interview with the testing person,the laboratory failed to perform the required six-month calibration for the Beckman Coulter AcT Diff analyzer due on January 1, 2021. FINDINGS: The testing person on July 13, 2021 at approximately 10: 00 AM, that the laboratory did not perform the required six month calibration for the hematology analyzer due in January 2021. a. The laboratory's calibration policy and the manufacturer policy for the Beckman Coulter AcT Diff hematology analyzer requires the analyzer to be calibrated every six months and/or as needed after preventative maintenance. b. The calibration was due January 1, 2021 therefore, the analyzer was out if calibration from January 1, 2021 through survey date July 13, 2021. c. Approximately 150 patient specimens were tested and reported for hematology during the time period when analyzer was out of calibration. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on surveyor's review of the laboratory's calibration and calibration verification procedures, lack of calibration verification records and an interview with the testing person, laboratory failed to perform the six-month calibration verification for the Alfa Wasserman ACE chemistry analyzer due on January 1, 2021. FINDINGS: 1. The laboratory testing person confirmed on July 13, 2021 at approximately 10:30 AM, laboratory failed to perform the six-month calibration verification for the Alfa Wasserman ACE chemistry analyzer due in January 1, 2021. a. the laboratory did not perform the required calibration verification for those test analyte's that have less than -- 2 of 3 -- 3-point calibrator. The chemistry analyzer performs a 1-point calibrator Gemcal as required, therefore, calibration verification is required every six-months. b. Approximately 175 patients were tested and reported during this time period. 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 surveyor findings and interview with the laboratory testing person, the laboratory director failed to provide overall management of the laboratory. The laboratory director failed to ensure that the laboratory maintained the laboratory's QC program for chemistry and hematology. Refer to D6020 D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on a surveyor's review of chemistry and hematology QC records and confirmed in an interview with the laboratory testing person at the time of this survey, the laboratory director failed to ensure that the QC program for chemistry and endocrinology was maintained to assure the quality of laboratory services. Refer to: D5437 and D5439. -- 3 of 3 --

Summary Statement of Deficiencies D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the surveyor's review of laboratory records for the GenBio Immuno-DOT Antinuclear Antibody (ANA) and the Biokit rheumajet Rheumatoid Factor (RF) - Latex Agglutination test kit, and an interview with the laboratory testing person, the laboratory failed to document the quality control results for the above kits. FINDINGS: 1. The testing person confirmed on September 5, 2018 at approximately 11:00 AM, that quality control records for the ANA testing from July 20, 2016 to May 8, 2017 and RF testing from July 20, 2016 to September 5, 2018 were not available for review at survey. 2. The Biokit rheumajet RF -Latex Agglutination test kit requires that the positive and negative controls (included in the test kits) be performed to ensure that the latex reagent is performing properly for accurate and reliable testing. 3. The ImmunoDot ANA Screening panel test kit used by the laboratory for ANA testing requires that the positive and negative controls be performed to ensure that the reagents are active for accurate and reliable testing. Approximately 125 patient samples were tested and reported for ANA and 55 patient samples were tested and reported for RF. With your