Westchester Medical Group Pllc

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 Red Blood Cell Count (RBC) and Hematocrit (Hct). The following scores were assigned: speciality Hematology 2022 third event =60% 2023 first event = 66% RBC 2022 third event 60% 2023 first event = 0% Hct 2022 third event =60% 2023 first event = 0% This is considered unsuccessful PT performance. Refer to D2130 and D2131 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 -- D2121 HEMATOLOGY CFR(s): 493.851(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 API PT program, the laboratory failed to participate successfully in proficiency testing for the test analyte's Cell Identification (Cell I.D.)/White Blood Differential (WBC Diff.), Hemoglobin (Hgb), White Blood Count (WBC) and Platelet The following scores were assigned: Cell I.D./WBC Diff 2022 third event = 60% Hgb 2022 third event = 60% WBC 2022 third event = 60% Platelet 2022 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 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 test analyte's Red Blood Cell Count (RBC) and Hematocrit (Hct). The following scores were assigned: RBC 2022 third event 60% 2023 first event = 0% Hct 2022 third event =60% 2023 first event = 0% 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 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. The following scores were assigned: speciality Hematology 2022 third event =60% 2023 first event = 66% 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 -- 2 of 3 -- with 493.1407 of this subpart. This CONDITION is not met as evidenced by: ased 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 RBC, Hct, Cell I.D.)/ WBC Diff), Hgb, WBC and Platelet The following scores were assigned: speciality Hematology 2022 third event =60% 2023 first event = 66% RBC 2022 third event 60% 2023 first event = 0% Hct 2022 third event =60% 2023 first event = 0% This is considered unsuccessful PT performance 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 RBC, Hct, Cell I.D./WBC Diff., Hgb, WBC, Platelet. The following scores were assigned: speciality Hematology 2022 third event =60% 2023 first event = 66% RBC 2022 third event 60% 2023 first event = 0% Hct 2022 third event =60% 2023 first event = 0% This is considered unsuccessful PT performance The following scores were assigned: Cell I.D./WBC Diff 2022 third event = 60% Hgb 2022 third event = 60% WBC 2022 third event = 60% Platelet 2022 third event = 60% This is considered unsatisfactory PT performance -- 3 of 3 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the laboratory's training & competency evaluation policy, review of the testing personnel training& competency records and an interview with the general supervisors, the laboratory director failed to follow the laboratory's establish training & competency evaluation policy for three newly hired testing personnel. FINDINGS: 1. The laboratory failed to follow the established written training & competency evaluation policy, which requires a six-month competency evaluation after training and an annual evaluation for the first year of hire. 2. The laboratory failed to perform and document the six month competency evaluation for three of the newly hired testing personnel. a. Testing person #1 (TP #1) hired 8/12/19 training completed on 12/19/19 and an annual evaluation 12/10/20; lack of documentation for six month evaluation due 6/2020. b. Testing person #2 (TP #2) hired 12/21/20 training completed on 1/28/21 and annual evaluation 12/15/21; lack of documentation for six- month evaluation due 7/2021 c. Testing person #3 (TP #3) hired 3/16/20 training completed 3/24/20; and annual evaluation 4/22/21; lack of documentation for six month evaluation due 9/2020 3. The general supervisors confirmed on February 16, 2022 at approximately 3:30 PM, that the laboratory failed to follow their written competency evaluation policy and perform the six-month evaluations for the three newly hired testing personnel. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) 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 -- The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on surveyor's review of the laboratory's training & competency evaluation policy, review of the testing personnel training & competency evaluation records and confirmed in an interview with the general supervisors, the laboratory director and technical consultant, failed to perform the six month competency evaluation for three of the testing personnel during the first year of patient testing. Refer to D5209. -- 2 of 2 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a review of storage refrigerator temperature records and an interview with the laboratory managers, the laboratory's storage refrigerator temperature was not within acceptable and remediation was not performed. Findings Include: 1) Controls and calibrator for the AcT Diff II are stored in the storage refrigerator located in the phlebotomy area. 2) The manufacturer package insert states that controls and calibrator are to be stored at a temperature range of 2 - 8 C. 3) It was confirmed with the laboratory managers on May 2, 2019, at approximately 12:45 pm that the refrigerator temperatures were out of acceptable range for the following days and remediation was not performed: April 18, 19, 2018 - 1C May 11, 2018 - 0C May 23, 27, 2018 - 15C June 5, 7, 8, 9, 23, and 25, 2018 - 9C June 9, 11, 12, 13, 14, 16, 20, and 21, 2018 - 10C June 18, 2018 - 13C June 19, 2018 - (-2C) June 30, 2018 - 0C July 9, 2018 - 9C July 31, 2018 - 0C August 27, 2018 - 10C January 19, 2019 - 0C January 26, 2019 - 1C February 8, 2019 - 1C March 22, 30, 2019 - 1C March 30, 31, 2019 - 1C April 19, 26, 2019 - 1C Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --