Chana E Gelbfish Md

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 testing (PT) desk review of the Center for Medicare and Medicaid Services (CMS) PT data reports and PT records from the College of American Pathologist (CAP) 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: 2020 third event =0% (non-participation) 2021 first event = 0% (non-participation) This is considered unsuccessful PT performance. Refer to D2130 and D3131. 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 records from the CAP 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: 2020 third event =0% (non-participation) 2021 first 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 CAP PT program, the laboratory failed to participate successfully in proficiency testing for the speciality Hematology. The following scores were assigned: 2020 third event =0% (non-participation) 2021 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 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 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; -- 2 of 3 -- 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 Hematology and the test analyte's WBC, RBC, Hgb, Hct, Platelet and Cell I.D./WBC Diff. The following scores were assigned: 2020 third event =0% (non-participation) 2021 first event = 0% (non- participation) This is considered unsuccessful PT performance -- 3 of 3 --

Summary Statement of Deficiencies 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 surveyor's review of the College of American Pathologists (CAP) Proficiency testing (PT) 2018 and 2019 records and an interview with the laboratory testing person, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analytes White Blood Cell Count (WBC) , Red Blood Cell Count (RBC), Hematocrit (HCT) and Hemoglobin (Hgb). The following scores were assigned: 2019 second event = 60% for each analyte This is considered a unsatisfactory PT performance. D2122 HEMATOLOGY CFR(s): 493.851(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 surveyor's review of the CAP PT 2018 and 2019 records and an interview with the laboratory testing person, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test speciality Hematology. The following scores were assigned: 2019 second event = 70% This is considered a unsatisfactory PT performance. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES 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): 493.1235 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 a review of the laboratory's competency assessment policies, competency evaluation records and an interview with the laboratory testing person, the laboratory failed to follow their establish written policies and procedures to assess the competency of the laboratory testing personnel that perform both Bacteriology/throat cultures and Hematology/CBC testing. FINDINGS: The laboratory testing person confirmed on October 10, 2019 at approximately 2:00 PM, that the laboratory did not follow the established competency evaluation policy. The laboratory did not perform annual 2018 competency evaluation for five of five laboratory testing personnel who perform moderate complexity testing. 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 the surveyor's review of CAP PT reports and an interview with the laboratory testing person, the laboratory failed to review and evaluate for the CAP PT for both the sub-specialty bacteriology throat cultures and Hematology for all 3 events in 2018 and the 1st & second events of 2019. FINDINGS: The laboratory testing person confirmed on October 10, 2019 at approximately 2:00 PM, that the laboratory director failed to review and evaluate the CAP PT results for all 3 events in 2018 and the 1st and 2nd events of 2019 for both the sub-specialty bacteriology/throat cultures and Hematology. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on a surveyor's review of the laboratory's Quality Assurance (QA) policy and confirmed in an interview with the laboratory manager and testing person, the laboratory failed to follow their established written QA policy and perform an annual QA review, as required by the laboratory's QA policy, for the calendar year 2018. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 -- 2 of 4 -- 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 surveyor's findings and an interview with the laboratory testing person, the laboratory director failed to provide overall management of the laboratory. The laboratory director failed to ensure that the laboratory: 1. Evaluated the CAP PT summary reports and perform