Leon Nitkin Md Ob/Gyn

Summary Statement of Deficiencies D0000 Based on a proficiency testing (PT) desk review survey performed on June 11, 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 (CASPER 0155D) and College of American Pathologists (CAP) PT summary reports, 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 failed to successfully participate in the CMS approved PT program for two of three consecutive testing events in the Hematology specialty and two of three consecutive testing events in the Red Blood Cell (RBC) and Hematocrit (HCT) (Non- Waived) test analytes in 2025 resulting in unsuccessful performance. Refer to D2130 and D2131. 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 CAP PT summary reports from 2025, the laboratory failed to achieve satisfactory performance (80% or greater) for two of three consecutive testing events for the analytes RBC and HCT (Non-Waived). FINDINGS: a. A review of the CASPER 155 report revealed the following unsatisfactory scores: 1. RBC Test Analyte: 2025 First Event = 40% 2025 Second Event = 20% 2. HCT (Non-Waived) Test Analyte: 2025 First Event = 0% 2025 Second Event = 20% b. A review of the PT scores from CAP (2025) confirmed the above test event 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 CAP PT summary reports from 2025, 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: 2025 First Event = 73% 2025 Second Event = 73% b. A review of the PT scores from CAP (2025) 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 CAP PT summary reports from 2025, 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) -- 2 of 3 -- (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 CAP PT 2025-1 and 2025-2 summary reports, the LD failed to ensure successful participation in an HHS approved PT program. Refer to D2130. -- 3 of 3 --

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 College of American Pathologists (CAP) PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the speciality General Immunology and the test analyte's Alpha Fetoprotein (AFP), Hepatitis B Core Antibody (Anti HBc) and Creatinine Kinase(CK) and Thyroid Stimulating Hormone (TSH). The following scores were assigned: General Immunology. 2021 third event = 65% 2022 first event = 65% 2022 second event = 65% Alpha Fetoprotein (AFP) 2021 third event = 60% 2022 first event = 60% 2022 second event = 60% Hepatitis B Core Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- Antibody (Anti HBc) 2022 first event = 0% 2022 second event = 0% 2022 third event = 0% This is considered repeatedly unsuccessful PT performance. Creatinine Kinase (CK) 2022 first event = 0% 2022 second event = 0% Thyroid Stimulating Hormone (TSH). 2021 third event = 60% 2022 first event = 60% This is considered unsuccessful PT performance. Refer to D2084, D2085, D2096 and D2107 D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(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 a PT desk review of the CMS PT reports and PT records from the CAP PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analyte Alpha Fetoprotein (AFP) Hepatitis B Core Antibody (Anti HBc) The following scores were assigned: Alpha Fetoprotein (AFP) 2021 third event = 60% 2022 first event = 60% 2022 second event = 60% Hepatitis B Core Antibody (Anti HBc) 2022 first event = 0% 2022 second event = 0% 2022 third event = 0% This is considered repeatedly unsuccessful PT performance D2085 GENERAL IMMUNOLOGY CFR(s): 493.837(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 a PT desk review of the CMS PT reports and PT records from the CAP PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the speciality General Immunology. The following scores were assigned: 2021 third event = 65% 2022 first event = 65% 2022 second event = 65% This is considered repeatedly unsuccessful PT performance D2087 ROUTINE CHEMISTRY CFR(s): 493.841(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 PT desk review of the CMS PT data reports and PT records from the CAP PT program, the laboratory failed to participate successfully in proficiency testing for the test analyte Total Lactate Dehydrogenase (LDH) The following scores were assigned: 2022 first event = 0% This is considered unsatisfactory PT performance. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) -- 2 of 4 -- 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 a PT desk review of the CMS PT reports and PT records from the CAP PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test Creatinine kinase (CK) The following scores were assigned: 2022 first event = 0% 2022 second event = 0% This is considered unsuccessful PT performance 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 a PT desk review of the CMS PT reports and PT records from the CAP PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analyte Thyroid Stimulating Hormone (TSH). The following scores were assigned: 2021 third event = 60% 2022 first event = 60% 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 PT CMS data reports and CAP 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, for the specialty General Immunology and the test analyte's AFP, Anti- HBc, CK, TSH and LDH. 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 director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; -- 3 of 4 -- This STANDARD is not met as evidenced by: Based on PT desk review of the CMS PT and CAP 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 General Immunology and the test analyte's AFP, Anti HBC, CK, TSH and LDH. The following scores were assigned: General Immunology. 2021 third event = 65% 2022 first event = 65% 2022 second event = 65% Alpha Fetoprotein (AFP) 2021 third event = 60% 2022 first event = 60% 2022 second event = 60% Hepatitis B Core Antibody (Anti HBc) The following scores were assigned: 2022 first event = 0% 2022 second event = 0% 2022 third event = 0% This is considered repeatedly unsuccessful PT performance. Creatinine Kinase (CK) 2022 first event = 0% 2022 second event = 0% Thyroid Stimulating Hormone (TSH). 2021 third event = 60% 2022 first event = 60% This is considered unsuccessful PT performance. Total Lactate Dehydrogenase (LDH) The following scores were assigned: 2022 first event = 0% This is considered unsatisfactory PT performance. -- 4 of 4 --

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 College of American Pathologists (CAP) PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analyte's Alpha Fetoprotein (AFP), Thyroid Stimulating Hormone (TSH). The following scores were assigned: 2021 third event = 60% 2022 first event = 60% This is considered unsuccessful PT performance. Refer to D2085 and D2107 D2075 GENERAL IMMUNOLOGY Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- CFR(s): 493.837(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 a PT desk review of the CMS PT reports and PT records from the CAP PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analyte Hepatitis B Core Antibody (Anti HBC) The following scores were assigned: 2022 first event = 0% This is considered unsatisfactory PT performance D2076 GENERAL IMMUNOLOGY CFR(s): 493.837(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on a PT desk review of the CMS PT reports and PT records from the CAP PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the speciality General Immunology. The following scores were assigned: 2022 first event = 65% This is considered unsatisfactory PT performance D2085 GENERAL IMMUNOLOGY CFR(s): 493.837(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 a PT desk review of the CMS PT reports and PT records from the CAP PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analyte Alpha Fetoprotein (AFP). The following scores were assigned: 2021 third event = 60% 2022 first event = 60% This is considered unsuccessful PT performance. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(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 PT desk review of the CMS PT data reports and PT records from the CAP PT program, the laboratory failed to participate successfully in proficiency testing for the test analyte's Total Creatine Kinase and Total Lactate Dehydrogenase (LDH) The -- 2 of 4 -- following scores were assigned: 2022 third event = 0% This is considered unsatisfactory PT performance. 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 a PT desk review of the CMS PT reports and PT records from the CAP PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analyte Thyroid Stimulating Hormone (TSH). The following scores were assigned: 2021 third event = 60% 2022 first event = 60% 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 CAP 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 General Immunology and the test analyte's AFP, Anti HBC, CK, LDH and TSH. 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 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 CAP 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 General Immunology and the test analyte's AFP, Anti HBC, CK, LDH and TSH. The following scores were assigned: AFP and TSH 2021 third event = 60% 2022 first event = 60% This is considered -- 3 of 4 -- unsuccessful PT performance. Speciality General Immunology 2022 first event = 65% Anti HBC, 2022 first event = 0% CK and LDH 2022 third event = 0% This is considered unsatisfactory PT performance. -- 4 of 4 --

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 Center for Medicare Medicaid Service (CMS) PT reports and PT records from the College of American Pathologists (CAP) PT program, the laboratory failed to participate and perform successfully in a PT program approved by CMS, for the specialty General Immunology. The following scores were assigned: 2018 second event = 46% 2019 first event = 75% This is considered unsuccessful PT performance. Refer to D2084. D2075 GENERAL IMMUNOLOGY CFR(s): 493.837(a) 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 -- 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 a PT desk review of CMS PT and PT records from the CAP PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analytes Alpha -Fetoprotein (AFP), Anti-Human Immunodeficiency Virus (HIV) 1/2 and Anti-Hepatitis B Core Antigen (HBC). The following scores were assigned: Alpha -Fetoprotein (AFP) 2019 first event = 0% Anti- Human Immunodeficiency Virus (HIV) 1/2 2018 second event = 40% Anti-Hepatitis B Core Antigen (HBC) 2018 second event = 0% This is considered unsatisfactory PT performance. D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(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 a PT desk review of CMS PT reports and PT records from the CAP PT program, the laboratory failed to participate and perform successfully in a PT program approved by CMS, for the specialty General Immunology. The following scores were assigned: 2018 second event = 46% 2019 first event = 75% 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 PT CMS data reports and CAP 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, for the specialty General Immunology and the test analytes AFP, Anti-HIV 1/2 and Anti- HBC. 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 director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as -- 2 of 3 -- required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on PT desk review of the PT CMS data reports and CAP 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, for the specialty General Immunology and the test analytes AFP, Anti-HIV 1/2 and Anti- HBC. The following scores were assigned: 2018 second event = 46% 2019 first event = 75% This is considered unsuccessful PT performance. Alpha -Fetoprotein (AFP) 2019 first event = 0% Anti-Human Immunodeficiency Virus (HIV) 1/2 2018 second event = 40% Anti-Hepatitis B Core Antigen (HBC) 2018 second event = 0% This is considered unsatisfactory PT performance. -- 3 of 3 --

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 the surveyor's review of proficiency testing (PT) records from the College of American Pathologists (CAP) and an interview with the testing person and the technical consultant, the laboratory failed to participate and perform successfully in a PT program approved by the Centers for Medicare and Medicaid Services (CMS) for the Hematology specialty and for the following analyte: Cell Identification/White Blood Cell Differential. The following scores were assigned: Cell Identification/White Blood Cell Differential 2018 first event = 0% (failure to participate) 2018 third event = 0% 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 the surveyor's review of proficiency testing (PT) records from the College of American Pathologists (CAP) PT program and an interview with the testing person and the technical consultant, the laboratory failed to successfully participate in a PT program approved by the Centers for Medicare and Medicaid Services (CMS) for the specialty Hematology. The following score was assigned: Hematology Specialty 2018 first 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 the surveyor's review of proficiency testing (PT) records from the College of American Pathologists (CAP) program and an interview with the testing person and the technical consultant, the laboratory failed to achieve a satisfactory performance for the following analyte: Cell Identification/White Blood Cell Differential. The following scores were assigned: Cell Identification/White Blood Cell Differential 2018 first event = 0% (failure to participate) 2018 third event = 0% 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 the surveyor's review of proficiency testing (PT) records from the (CAP) PT program and an interview with the testing person and the technical consultant, the laboratory director failed to fulfill the laboratory director's responsibilities and ensure -- 2 of 3 -- that the laboratory achieved a satisfactory performance and successfully participated in a PT program for the Hematology Specialty and for the following analyte: Cell Identification/White Blood Cell Differential. 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 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 the surveyor's review of proficiency testing (PT) records from the College of American Pathologists (CAP), and an interview with the testing person and the technical consultant, the laboratory director failed to ensure that the laboratory achieved a satisfactory performance and successfully participated and in a PT program for the Hematology specialty and the test analyte: Cell Identification/White Blood Cell Differential. The following scores were assigned: Hematology Specialty 2018 first event = 0% This is considered unsatisfactory performance. Cell Identification/White Blood Cell Differential 2018 first event = 0% (failure to participate) 2018 third event = 0% This is considered unsuccessful PT performance. -- 3 of 3 --