Dr Sharon Rais & Dr Melinda Mann Llp

Summary Statement of Deficiencies D2005 ENROLLMENT CFR(s): 493.801(a)(4) Authorize the proficiency testing program to release to HHS all data required to-- (i) Determine the laboratory's compliance with this subpart; and (ii) Make PT results available to the public as required in section 353(f)(3)(F) of the Public Health Service Act. This STANDARD is not met as evidenced by: Based on a proficiency testing ( PT) desk review of the Center for Medicare and Medicaid Services (CMS) PT records and the verified with the College of American Pathologists (CAP) PT program, the laboratory failed to have the PT test results released to New York State Department of Health (NYSDOH), Physician Office Laboratory Evaluation Program (POLEP) in the calendar years 2021 and 2022. 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 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 -- 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 PT desk review of the CMS PT and CAP PT program records, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test specialities General Immunology, Hematology, sub-speciality Bacteriology and the test analyte's Anti- Human Immunodeficiency Virus (HIV), Hepatitis B Surface Antigen (Hbs-Ag), Anti- Hepatitis Core Antibody (HBC) and Cell Identification (Cell I.D.), Red Blood Cell Count (RBC), Hemoglobin (Hgb), Hematocrit (Hct), White Blood Cell Count (WBC) and Platelets. The following scores were assigned: General Immunology and Anti-HIV, HBS AG, Anti-HBC 2021 third event = 0% 2022 first event = 0% Sub-speciality Bacteriology. 2021 second event = 9% 2021 third event = 100% 2022 first event = 0% This is considered unsuccessful PT performance Speciality Hematology, Cell I.D., RBC, Hgb, Hct, WBC and Platelets 2021 second event = 0% 2021 third event = 60% 2022 first event = 0% This is considered repeatedly unsuccessful PT performance. Refer to D2028, D2085 and D2130. D2028 BACTERIOLOGY CFR(s): 493.823(e) 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 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 sub-speciality Bacteriology. The following scores were assigned: 2021 second event = 9% 2021 third event = 100% 2022 first event = 0% This is considered unsuccessful PT performance. D2066 SYPHILIS SEROLOGY CFR(s): 493.835(a) 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 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 speciality Syphilis Serology. The following scores were assigned: 2021 third event = 0% This is considered unsatisfactory PT performance D2085 GENERAL IMMUNOLOGY CFR(s): 493.837(g) -- 2 of 4 -- 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 CMS PT reports and lack of 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 and test analyte's Anti-HIV, HBS AG, Anti-HBC. The following scores were assigned: General Immunology and Anti-HIV, HBS AG, Anti-HBC 2021 third event = 0% 2022 first event = 0% 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 Glucose. The following scores were assigned: 2021 third event = 60% 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 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 Hematology and the test analyte's Cell I. D., RBC, Hgb, Hct and Platelets. The following scores were assigned: Speciality Hematology, Cell I.D., RBC, Hgb, Hct, WBC and Platelets 2021 second event = 0% 2021 third event = 60% 2022 first event = 0% This is considered repeatedly 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 -- 3 of 4 -- that the laboratory achieved a satisfactory performance and successfully participate in a PT program, approved by CMS, for the specialities Syphilis Serology, General Immunology, Hematology, sub-speciality Bacteriology and the test analyte's Anti- HIV, Hbs-Ag, Anti-HBC, Cell I.D., RBC, Hgb, Hct, WBC, Platelets and Glucose. 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 specialities specialities General Immunology, Hematology, sub-speciality Bacteriology and the test analyte's Anti- HIV, Hbs-Ag, Anti-HBC, Cell I.D., RBC, Hgb, Hct, WBC, Platelets and Glucose. The following scores were assigned: General Immunology and Anti-HIV, HBS AG, Anti-HBC 2021 third event = 0% 2022 first event = 0% Sub-speciality Bacteriology. 2021 second event = 9% 2021 third event = 100% 2022 first event = 0% This is considered unsuccessful PT performance Speciality Hematology, Cell I.D., RBC, Hgb, Hct, WBC and Platelets 2021 second event = 0% 2021 third event = 60% 2022 first event = 0% This is considered repeatedly unsuccessful PT performance. Speciality Syphilis Serology. 2021 third event = 0% Glucose. 2021 third event = 60% This is considered unsatisfactory PT performance. -- 4 of 4 --

Summary Statement of Deficiencies D2005 ENROLLMENT CFR(s): 493.801(a)(4) Authorize the proficiency testing program to release to HHS all data required to-- (i) Determine the laboratory's compliance with this subpart; and (ii) Make PT results available to the public as required in section 353(f)(3)(F) of the Public Health Service Act. This STANDARD is not met as evidenced by: Based on a proficiency testing ( PT) desk review of the Center for Medicare and Medicaid Services (CMS) PT records and the verified with the College of American Pathologists (CAP) PT program, the laboratory failed to have the PT test results released to New York State Department of Health (NYSDOH), Physician's Office Evaluation Program (POLEP) in the calendar year 2020 and 2021. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- 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 data reports, and the lack of the College of American Pathologists (CAP) PT records, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the speciality General Immunology & test analyte Rubella; test analyte Chloride (CL) and the speciality Endocrinology. The following scores were assigned: Speciality General Immunology 2020 second event = 0% 2020 third event = 75% 2021 first event = 75% Rubella 2020 second event = 0% 2020 third event = 0% 2021 first event = 0% Chloride (CL) 2020 second event = 0% 2020 third event =100% 2021 first event =60% Speciality Endocrinology 2020 second event = 60% 2020 third event =76% This is considered an unsuccessful PT performance Refer to D2084, D2085, D2096 and D2108 D2020 BACTERIOLOGY CFR(s): 493.823(a) 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 PT desk review of the CMS PT data reports and lack of PT records from the CAP PT program, the laboratory failed to participate successfully in proficiency testing for the sub-specialty Bacteriology. The following score was assigned: 2020 second event = 9% This is considered unsatisfactory PT performance. D2075 GENERAL IMMUNOLOGY 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 PT desk review of the CMS PT data reports and lack of PT records from the CAP PT program, the laboratory failed to participate successfully in proficiency testing for the test analyte's Hepatitis B surface Antigen (HBsAg ), Anti-Human Immunodeficiency Virus (HIV) and Hepatitis B Core Antibody (Anti-HBc). The following score was assigned: 2020 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. -- 2 of 5 -- This STANDARD is not met as evidenced by: Based on a PT desk review of the CMS PT data reports and lack of 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 analyst Rubella. The following scores were assigned: 2020 second event = 0% 2020 third event= 0% 2021 first 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 CMS PT reports and lack of 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: 2020 second event = 0% 2020 third event = 75% 2021 first event = 75% 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 lack of PT records from the CAP PT program, the laboratory failed to participate successfully in proficiency testing for the test analyte's Alanine Aminotransferase (ALT/SGPT), Alkaline Phosphates, Aspartate Aminotransferase (AST/SGOT), Total Creatine kinase (CK), Total Lactate Dehydrogenase (LDH), Potassium (K), Sodium (Na) and Blood Urea Nitrogen (BUN) The following score was assigned: 2020 second event = 0% This is considered unsatisfactory PT performance. D2088 ROUTINE CHEMISTRY CFR(s): 493.841(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 data reports and lack of 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 Chemistry. The following scores were assigned: 2020 second event = 57% This is considered a unsatisfactory PT performance. -- 3 of 5 -- D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 data reports and lack of the CAP PT program records, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analyte Chloride (CL) The following scores were assigned: Chloride 2020 second event = 0% 2020 third event = 100% 2021 first event = 60% This is considered unsuccessful PT performance. D2098 ENDOCRINOLOGY CFR(s): 493.843(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 lack of PT records from the CAP PT program, the laboratory failed to participate successfully in proficiency testing for the test analyte's Human Chrionic Gonadotropin (Hcg), Triiodothyronne (T3) and Thyroid Stimulating Hormone (TSH). The following score was assigned: Hcg and TSH 2020 second event = 0% T3 2020 third event = 0% This is considered unsatisfactory 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 on a PT desk review of the CMS PT data reports and lack of PT records from the CAP PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the sub-specialty Endocrinology. The following scores were assigned: 2020 second event = 60% 2020 third event = 76% This is considered a 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. -- 4 of 5 -- This CONDITION is not met as evidenced by: Based on PT desk review of the CMS PT data reports and lack of 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 specialities General Immunology & Routine Chemistry, sub-specialities Endocrinology & Bacteriology and the test analyte's Anti-HIV, HBS AG, Anti, HBC, Rubella, ALT/SGPT, AST /SGOT, Alkaline Phosphates, CL, Total CK, Total LDH, K, Na, BUN, Hcg, T3 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 data reports and lack of 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 specialities General Immunology & Routine Chemistry, sub-specialities Endocrinology & Bacteriology and the test analyte's Anti-HIV, HBsAg, Anti-HIV, Anti- HBc, Rubella, ALT/SGPT, AST/SGOT, Alkaline Phosphates, CL, Total CK, Total LDH, K, Na, BUN, Hcg, T3 and TSH. The following scores were assigned: Speciality General Immunology 2020 second event = 0% 2020 third event = 75% 2021 first event = 75% Rubella 2020 second event = 0% 2020 third event = 0% 2021 first event = 0% Chloride (CL) 2020 second event = 0% 2020 third event =100% 2021 first event =60% Sub-speciality Endocrinology 2020 second event = 60% 2020 third event =76% This is considered and unsuccessful PT performance Sub-specialty Bacteriology. The following score was assigned: 2020 second event = 9% HBsAg, Anti-HIV and Anti-HBc. 2020 second event = 0% Specialty Chemistry. 2020 second event = 57% ALT/SGPT, Alkaline Phosphates, AST/SGOT, T CK, T LDH, K, Na and BUN 2020 second event = 0% Hcg, T3 and TSH Hcg and TSH 2020 second event = 0% T3 2020 third event = 0% This is considered unsatisfactory PT performance. -- 5 of 5 --

Summary Statement of Deficiencies D2005 ENROLLMENT CFR(s): 493.801(a)(4) Authorize the proficiency testing program to release to HHS all data required to-- (i) Determine the laboratory's compliance with this subpart; and (ii) Make PT results available to the public as required in section 353(f)(3)(F) of the Public Health Service Act. This STANDARD is not met as evidenced by: Based on a proficiency testing ( PT) desk review of the Center for Medicare and Medicaid Services (CMS) PT records and the verified with the College of American Pathologists (CAP) PT program, the laboratory failed to have the PT test results released to New York State Department of Health (NYSDOH), Physician Office Laboratory Evaluation Program (POLEP) in the calendar year 2020. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- 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, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analytes Chloride (CL), BUN, Human Chorionic Gonadotropin (Hcg),Triiodothyronine (T3), Cell Identification (Cell I.D.) and the sub-specialty Endocrinology. The following scores were assigned: Chloride (CL) 2019 third event = 40% 2020 first event = 0% [non- participation] BUN 2019 second event = 60% 2019 third event = 80% 2020 first event = 0% [non-participation] Human Chorionic Gonadotropin (Hcg) 2019 third event = 40% 2020 first event = 0% [non-participation] Triiodothyronine (T3), 2019 third event = 60% 2020 first event = 0% non-participation] Cell Identification (Cell I.D.) 2019 third event = 60% 2020 first event = 0% [non-participation] Sub-specialty Endocrinology 2019 third event = 76% 2020 first event = 0% [non-participation] This is considered unsuccessful PT performance. Refer to D2096, D2107 and D2130. D2089 ROUTINE CHEMISTRY CFR(s): 493.841(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 a PT desk review of the CMS PT reports, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the speciality Chemistry and the eighteen test analytes. 2020 first event = 0% [non-participation] This is considered unsatisfactory PT performance D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analyte Chloride (CL) and BUN The following scores were assigned: Chloride 2019 third -- 2 of 5 -- event = 40% 2020 first event = 0% [non-participation] BUN 2019 second event = 60% 2019 third event = 80% 2020 first event = 0% [non-participation] This is considered unsuccessful PT performance. D2100 ENDOCRINOLOGY CFR(s): 493.843(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 a PT desk review of the CMS PT reports, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analytes Free Thyroxine (FTY), T3 uptake and Thyroid Stimulating Hormone (TSH) 2020 first event = 0% [non-participation] 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, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the sub-specialty Endocrinology and the test analytes Triiodothyronine (T3) and Hcg. The following scores were assigned: Sub-specialty Endocrinology 2019 third event = 76% 2020 first event = 0% [non-participation] Triiodothyronine (T3) 2019 third event = 60% 2020 first event = 0% [non-participation] Hcg 2019 third event = 40% 2020 first event = 0% [non-participation] This is considered unsuccessful PT performance. 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. -- 3 of 5 -- This STANDARD is not met as evidenced by: Based on a PT desk review of the CMS PT reports, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the speciality Hematology and the test analytes Red Blood Cell Count (RBC), White Blood Cell Count (WBC), Hematocrit (Hct), Hemoglobin (Hgb) and Platelets. 2020 first event = 0% [non-participation] 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 a PT desk review of the CMS PT reports, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analytes Cell Identification (Cell I.D.) The following scores were assigned 2019 third event = 60% 2020 first event = 0% [non-participation] 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, 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 test analytes Chloride (CL), BUN, Hcg, T3, Cell Identification (Cell I.D.) and the sub- specialty Endocrinology and the test analytes, FTY, T3 uptake,TSH, speciality Chemistry and eighteen test analytes, speciality Hematology and the test analytes WBC, RBC, Hct, Hgb and Platelet. 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 PT CMS data reports, the laboratory director failed to -- 4 of 5 -- fulfill the laboratory director's responsibilities and ensure that the laboratory achieved a satisfactory performance and successfully participate in a PT program, for the test analytes Chloride (CL), Human Chorionic Gonadotropin (Hcg),Triiodothyronine (T3), Cell Identification (Cell I.D.) and the specialty Endocrinology, FTY,T3 uptake,TSH, speciality Chemistry and twenty two test analytes, speciality Hematology and the test analytes WBC, RBC, Hct, Hgb and Platelet. The following scores were assigned: Chloride (CL) 2019 third event = 40% 2020 first event = 0% non-participation] BUN 2019 second event = 60% 2019 third event = 80% 2020 first event = 0% [non- participation] Hcg 2019 third event = 40% 2020 first event = 0% [non-participation] Triiodothyronine (T3), 2019 third event = 60% 2020 first event = 0% [non- participation] Cell Identification (Cell I.D.) 2019 third event = 60% 2020 first event = 0% [non-participation] Sub-specialty Endocrinology 2019 third event = 76% 2020 first event = 0% [non-participation] This is considered unsuccessful PT performance. Speciality Chemistry and the twenty test analytes. (FTY), T3 uptake and TSH RBC, WBC, Hct, Hgb and Platelets. 2020 first event = 0% [non-participation] This is considered unsatisfactory PT performance. -- 5 of 5 --

Summary Statement of Deficiencies D2005 ENROLLMENT CFR(s): 493.801(a)(4) Authorize the proficiency testing program to release to HHS all data required to-- (i) Determine the laboratory's compliance with this subpart; and (ii) Make PT results available to the public as required in section 353(f)(3)(F) of the Public Health Service Act. This STANDARD is not met as evidenced by: Based on a proficiency testing ( PT) desk review of the Center for Medicare and Medicaid Services (CMS) PT records and the verified with the College of American Pathologists (CAP) PT program, the laboratory failed to have the PT test results released to New York State Department of Health (NYSDOH), Physician's Office Evaluation Program (POLEP) in the calendar year 2018 and 2019. 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 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 -- 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 testing (PT) desk review of the Center for Medicare and Medicaid Services (CMS) PT data reports and PT records from the College of American Pathologists (CAP) PT program, the laboratory failed to participate successfully in proficiency testing for the test analyte Total Calcium. The following scores were assigned: 2018 third event = 0% 2019 first event = 0% This is considered unsuccessful PT performance. Refer to 2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 records from the CAP PT program, the laboratory failed to participate successfully in proficiency testing for the test analyte Total Calcium. The following scores were assigned: 2018 third event = 0% 2019 first 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 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 test analyte Total Calcium. 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; -- 2 of 3 -- 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 test analyte Total Calcium. The following scores were assigned: 2018 third event = 0% 2019 first event = 0% This is considered unsuccessful PT performance. -- 3 of 3 --