Mitchell Berger Md Pllc

Summary Statement of Deficiencies D0000 Based on a proficiency testing (PT) desk review survey performed on February 12, 2025, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation. D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity. 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 review of Centers for Medicare & Medicaid Services (CMS) Proficiency Testing (PT) Certification and Survey Provider Enhanced Reporting system 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 -- (CASPER 0155D) and American Association of Bioanalysts-Medical Laboratory Evaluation (AAB-MLE) PT summary reports, the laboratory failed to successfully participate in the CMS approved PT program for two of three consecutive testing events in the Hematology specialty for the Cell Identification or White Blood Cell Differential (Cell ID or WBC Diff), Red Blood Cell (RBC), Hemoglobin (HGB) (Non- Waived), White Blood Cell (WBC) Count, and Platelets test analytes in 2023 resulting in unsuccessful performance. Refer to D2130 and 2131. 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 CMS PT CASPER 0155D and AAB-MLE PT summary reports from 2023, the laboratory failed to achieve satisfactory performance (80% or greater) for two of three consecutive testing events for the specialty Hematology in the analytes Cell ID or WBC Diff, RBC, HGB (Non-Waived), WBC Count, and Platelets. FINDINGS: a. A review of the CASPER 155 report revealed the following unsatisfactory scores: 1. Cell ID or WBC Diff Test Analyte: 2023 Second Event = 0% 2023 Third Event = 60% 2. RBC Test Analyte: 2023 Second Event = 0% 2023 Third Event = 40% 3. HGB (Non-Waived) Test Analyte: 2023 Second Event = 0% 2023 Third Event = 60% 4. WBC Count Test Analyte: 2023 Second Event = 0% 2023 Third Event = 60% 5. Platelets Test Analyte: 2023 Second Event = 0% 2023 Third Event = 60% b. A review of the proficiency testing scores from AAB-MLE (2023) confirmed the above findings. D2131 HEMATOLOGY CFR(s): 493.851(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 CMS PT CASPER 0155D and AAB-MLE PT summary reports from 2023, the laboratory failed to achieve satisfactory performance (80% or greater) for two of three consecutive testing events for the specialty Hematology. FINDINGS: a. A review of the CASPER 155 report revealed the following unsatisfactory scores: 1. Hematology Specialty: 2023 Second Event = 0% 2023 Third Event = 53% b. A review of the PT scores from AAB-MLE (2023) confirmed the above findings. 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. -- 2 of 3 -- This CONDITION is not met as evidenced by: Based on review of CMS PT CASPER 0155D and AAB-MLE PT summary reports from 2023, the Laboratory Director (LD) failed to provide overall management and direction of the laboratory services. 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 review of CMS PT CASPER 0155D and AAB-MLE PT 2023-2 and 2023-3 summary reports, the LD failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2130 and D2131. -- 3 of 3 --

Summary Statement of Deficiencies D0000 Based on a proficiency testing (PT) desk review survey performed on August 19, 2024, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation. D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity. 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 review of Centers for Medicare & Medicaid Services (CMS) Proficiency Testing (PT) Certification and Survey Provider Enhanced Reporting system 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 -- (CASPER 0155D) and Medical Laboratory Evaluation (MLE) PT summary reports, the laboratory failed to successfully participate in the CMS approved PT program for four of five consecutive testing events in the Hematology subspecialty for the HCT (Hematocrit) Non-Waived test analyte in 2023 and 2024, resulting in non-initial unsuccessful performance. Refer to D2130. 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 CMS PT CASPER 0155D and CAP PT summary reports from 2024, the laboratory failed to achieve satisfactory performance (80% or greater) for four of five consecutive testing events in the Hematology subspecialty for the HCT (Non-Waived) test analyte. FINDINGS: 1. A review of the CASPER 155 report revealed the following unsatisfactory scores: HCT (Non-Waived) Test Analyte: 2023 First Event = 60% 2023 Second Event = 0% 2023 Third Event = 40% 2024 Second Event = 60% 2. A review of the proficiency testing scores from MLE (2023 and 2024) confirmed the above findings. 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 CMS PT CASPER 0155D and MLE PT summary reports from 2023 and 2024, the laboratory director (LD) failed to failed to provide overall management and direction of the laboratory services. Refer to D2016. 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 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 review of CMS PT CASPER 0155D and MLE PT 2023-1, 2023-2, 2023-3, and 2024-2 summary reports, the LD failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2130. -- 2 of 2 --

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 a proficiency testing ( PT) desk review of the Center for Medicare and Medicaid Services (CMS) PT reports and PT records from the American Association of Bioanalysts Medical Laboratory Evaluation ( AAB-MLE) PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analyte Hematocrit (Hct). The following scores were assigned: Hct 2023 first event = 60% 2023 second event = 0% (failure to participate) This is considered unsuccessful PT performance. Refer to D2130 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 -- D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on PT desk review of the CMS PT reports and PT records from the AAB-MLE PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the speciality Hematology and the test analyte's Red Blood Cell Count (RBC), White Blood Cell Count (WBC), Hemoglobin (Hgb), Cell Identification (Cell I.D.) and Platelet. The following scores were assigned: 2023 second event = 0% (failure to participate) This is considered unsatisfactory PT performance. 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 PT desk review of the CMS PT reports and PT records from the AAB-MLE PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analyte Hematocrit (Hct). The following scores were assigned: Hct 2023 first event = 60% 2023 second event = 0% (failure to participate) 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 AAB-MLE 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 Hematology and the test analyte's Hct, RBC, WBC, Hgb, Cell I.D. and Platelet. Refer to D6016 D6016 LABORATORY DIRECTOR RESPONSIBILITIES -- 2 of 3 -- 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 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 AAB-MLE 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 Hematology and the test analyte's Hct, RBC, WBC, Hgb, Cell I.D. and Platelet. The following scores were assigned: Hct 2023 first event = 60% 2023 second event = 0% (failure to participate) This is considered unsuccessful PT performance. Hematology and RBC, WBC, Hgb, Cell I. D. and Platelet. 2023 second event = 0% (failure to participate) This is considered unsatisfactory PT performance. -- 3 of 3 --

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on surveyor's review of the manufacturer's packet inserts for the Siemens Multistix and interview with the laboratory director/testing person, the laboratory failed to follow the manufacturer's requirements for performing external positive and negative controls with each new vial opened for the Siemens Multistix. FINDINGS: 1. The packet insert for the Siemens Multistix requires that external controls be performed with each new Vial of Multistix opened. On December 21, 2020 at approximately 10:00 AM the laboratory director/testing person confirmed surveyor's findings that documentation for the required external control testing was not available from 5/1/2018 through 12/18/2020. 2. Approximately 250 patients specimens were tested and reported for urinalysis during the above time frame. PLEASE NOTE: THIS IS A RECITED DEFICIENCY FROM THE SURVEYS CONDUCTED ON JUNE 9, 2014, ON AUGUST 4, 2016, AND ON MAY 14, 2018. 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: 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 -- Based on the surveyor's review of Medical Laboratory Evaluation (MLE) Proficiency Testing (PT) reports and an interview with the laboratory director/testing person, the laboratory failed to evaluate, perform and document remedial action for the PT scores of less than 100% for the following analytes: 2019 third event: Platelets = 80% 2020 third event: Red Blood Cells (RBC) = 80% Hemoglobin (Hgb) = 80% Hematocrit (HCT) = 80% 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 a surveyor's findings and interview with the laboratory director/testing person, the laboratory director failed to provide overall management of the laboratory. The laboratory director failed to ensure that the laboratory: 1. Maintained the

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on surveyor's review of the manufacturer's packet inserts for the Siemens Multistix, and Henry Schein Rapid Strep and interview with the laboratory director /testing person, the laboratory failed to follow the manufacturer's requirements for performing external positive and negative controls with each new vial opened for the Siemens Multistix and each new kit of Henry Schein Rapid Strep. FINDINGS: 1. The packet insert for the Siemens Multistix requires that external controls be performed with each new Vial of Multistix opened. On May 14, 2018 at approximately 10:30 AM the laboratory director/testing person confirmed surveyor's findings that documentation for the required external control testing was not available for calendar years 2016 and 2017. 2. The packet insert for the Henry Schein Rapid Strep requires that external positive and negative controls, included in each test kit, be performed for each kit prior to use for patient testing. Documentation for the required external control testing was not available for the Henry Schein Rapid Strep in calendar years 2016, 2017 and up to survey date. 3. Approximately 200 patients specimens were tested and reported for urinalysis and approximately 30 patients specimens were tested and reported for Rapid Strep during above time frame. PLEASE NOTE: THIS IS A RECITED DEFICIENCY FROM THE SURVEYS CONDUCTED ON JUNE 9, 2014 AND ON AUGUST 4, 2016. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 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 -- 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 a surveyor's findings and interview with the laboratory director/testing person, the laboratory director failed to provide overall management of the laboratory. The laboratory director failed to ensure that the laboratory: 1. Maintained the