Northern Westchester Internal Medicine

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 Hematology and the test analyte's White Blood Cell Count (WBC), Red Blood Cell Count (RBC), Hemoglobin (Hgb), Hematocrit (Hct), White Blood Cell Differential/Cell Identification (WBC Diff /C.ID.) and Platelet. The following scores were assigned: 2023 first event =0% (failure to participate) 2023 second event = 0% (failure to participate) This is considered unsuccessful PT performance. Refer to D2130 and 2131 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 -- 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 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 WBC, RBC, Hgb, Hct, WBC Diff/C. ID. and Platelet. The following scores were assigned: 2023 first event =0% (failure to participate) 2023 second event = 0% (failure to participate) This is considered unsuccessful PT performance. D2131 HEMATOLOGY CFR(s): 493.851(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 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 Hematology. The following scores were assigned: 2023 first event =0% (failure to participate) 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 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 Hematology and the test analyte's WBC, RBC, Hgb, Hct, WBC Diff/C.ID. 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 -- 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 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 Hematology and the test analyte's WBC, RBC, Hgb, Hct, WBC Diff/C.ID. and Platelet The following scores were assigned: 2023 first event =0% (failure to participate) 2023 second event = 0% (failure to participate) This is considered unsuccessful PT performance -- 3 of 3 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) Proficiency Testing (PT) records, documents for the 2020, 2021, and 2022 test events, as well as an interview with the laboratory testing person (TP1), the laboratory failed to rotate the API PT samples among the two testing personnel who routinely perform hematology testing. FINDINGS: 1. Based upon the review of the 2020, 2021, and 2022 API PT attestation forms and test result forms, the laboratory failed to rotate the API PT samples among the two testing personnel who routinely perform hematology testing. The laboratory failed to participate in the 2021 first and second events. This was addressed during the 2021 second PT Desk Review Statement of Deficiencies (SOD) and the

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 American Proficiency Institute (API) 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 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 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 American Proficiency Institute (API) PT program, the laboratory failed to participate successfully in proficiency testing for the speciality Hematology and the test analyte's White Blood Cell Count (WBC), Red Blood Cell Count (RBC), Hemoglobin (Hgb), Hematocrit (Hct), Platelet and Cell Identification (Cell I.D.)/White Blood Cell Differential (WBC Diff.). The following scores were assigned: 2021 first event = 0% (non-participation) 2021 second event = 0% (non-participation) This is considered unsuccessful PT performance. Refer to D2130 and D2131. 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 data reports and PT records from the API PT program, the laboratory failed to participate successfully in proficiency testing for the test analyte's WBC, RBC, Hgb, Hct, Platelet and Cell I.D./WBC Diff.. The following scores were assigned: 2021 first event = 0% (non-participation) 2021 second event = 0% (non-participation) This is considered unsuccessful PT performance. D2131 HEMATOLOGY CFR(s): 493.851(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 PT desk review of the CMS PT data reports and PT records from the API PT program, the laboratory failed to participate successfully in proficiency testing for the speciality Hematology. The following scores were assigned: 2021 first event = 0% (non-participation) 2021 second 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. -- 2 of 3 -- 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 Hematology and the test analyte's WBC, RBC, Hgb, Hct, Platelet and Cell I.D./WBC Diff. 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 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 Hematology and the test analyte's WBC, RBC, Hgb, Hct, Platelet and Cell I.D./WBC Diff. The following scores were assigned: 2021 first event = 0% (non-participation) 2021 second event = 0% (non- participation) This is considered unsuccessful 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 a proficiency testing (PT) desk review of the Center for Medicare and Medicaid Services (CMS) PT reports and PT records from the American Proficiency Institute (API) PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analyte Red Blood Cell Count/Erythrocyte (RBC). The following scores were assigned: 2019 first event = 40% 2019 second event = 100% 2019 third event = 0% [non-participation] This is considered unsuccessful PT performance. Refer to D2130. D2123 HEMATOLOGY 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 -- 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 a PT desk review of the CMS PT reports and PT records from the API PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the specialty Hematology and the test analytes White Blood Cell Count (WBC), white Blood Cell Differential (WBC Diff.), Hematocrit (Hct), Hemoglobin (Hgb) and Platelets. The following scores were assigned: 2019 third 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 and PT records from the American API PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analyte RBC/Erythrocyte. The following scores were assigned: 2019 first event = 40% 2019 second event = 100% 2019 third 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 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, for the specialty Hematology and test analytes WBC, RBC, Cell I.D., Hct, Hgb and Platelets. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) -- 2 of 3 -- 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 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, for the specialty Hematology and the test analytes WBC, RBC, Cell I.D., Hct, Hgb and Platelets. The following scores were assigned: RBC /Erythrocyte 2019 first event = 40% 2019 second event = 100% 2019 third event = 0% [non-participation] This is considered unsuccessful PT performance Hematology and WBC, Hgb, Hct, WBC Diff and Platelets. 2019 third event = 0% [non- participation] This is considered unsatisfactory PT performance. -- 3 of 3 --

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on a review of proficiency test (PT) records and an interview with the laboratory testing person, the laboratory failed to perform PT testing in the same manner as patient specimen testing. Findings Include: It was confirmed by the laboratory testing person on November 19, 2019, at approximately, 11:00 am that PT specimens are always performed by one of two testing personnel, whereas, patient specimens are performed by both testing personnel. 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: Based on a review of the American Proficiency Institute (API) proficiency test (PT) reports and an interview with the laboratory testing person, the laboratory did not 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 -- evaluate, perform and document remedial action for the PT scores less than 100%. Findings Include: It was confirmed by the laboratory testing person on November 19, 2019, at approximately 11:00 am, that the laboratory failed to evaluate the following PT results: 2018 1st event Hematology Cell Identification = 93% D6021 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 quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on a review of QA procedures, reviews and an interview with the laboratory testing person, the director failed to ensure that the laboratory's QA program for hematology was maintained for all phases of laboratory testing. Refer to: D2006, and D5209 -- 2 of 2 --