De Fazio Ob/Gyn Laboratory

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 Pathologists (CAP) PT program, the laboratory failed to participate successfully in proficiency testing for the test analyte Triiodothyronine (T3). The following scores were assigned: 2020 first event = 0% 2020 second event = 0% This is considered unsuccessful PT performance. Refer to D2107. D2020 BACTERIOLOGY CFR(s): 493.823(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 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 sub-specialty Bacteriology. The following scores were assigned: 2020 first event = 75% This is considered an unsatisfactory PT performance D2038 MYCOLOGY CFR(s): 493.827(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 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 sub-specialty Mycology. The following scores were assigned: 2020 first event = 0% This is considered an 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 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 Triiodothyronine (T3). The following scores were assigned: 2020 first event = 0% 2020 second 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 -- 2 of 3 -- ensure that the laboratory achieved a satisfactory performance and successfully participate in a PT program, for the test analyte T3 and sub-specialties Bacteriology and Mycology. 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 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 T3 and sub-specialties Bacteriology and Mycology. The following scores were assigned: Triiodothyronine (T3). 2020 first event = 0% 2020 second event = 0% This is considered unsuccessful PT performance. Sub-specialty Bacteriology. 2020 first event = 75% Sub-specialty Mycology 2020 first event = 0% This is considered an unsatisfactory PT performance -- 3 of 3 --

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 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 a PT desk review of CMS PT reports, the laboratory failed to participate and perform successfully in a PT program approved by CMS, for the subspecialty Endocrinology. The following scores were assigned: 2019 first event = 76% 2019 second event = 60% This is considered unsuccessful PT performance. Refer to D2108. 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, the laboratory failed to participate successfully in proficiency testing for the test analyte Total Calcium. The following scores were assigned: Total Calcium 2019 second event = 60% This is considered unsatisfactory 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 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 (FT4) and Thyroxine. The following test scores were assigned : FT4 and Thyroxine 2019 second event = 0% This is considered a 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 CMS PT reports, the laboratory failed to participate and perform successfully in a PT program approved by CMS, for the subspecialty Endocrinology. The following scores were assigned: 2019 first event = 76% 2019 second event = 60% This is considered unsuccessful PT performance. -- 2 of 3 -- 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 subspeciality Endocrinology and the test analytes Total Calcium, FT4, and Thyroxine. 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 fulfill the laboratory director's responsibilities and ensure that the laboratory achieved a satisfactory performance and successfully participate in a PT program, for the subspeciality Endocrinology and the test analytes Total Calcium, FT4, and Thyroxine. The following scores were assigned: Specialty Endocrinology. 2019 first event = 76% 2019 second event = 60% This is considered unsuccessful PT performance. Total Calcium 2019 second event = 60% FT4 and Thyroxine 2019 second event = 0% This is considered unsatisfactory PT performance. -- 3 of 3 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: . Based on the surveyor's review of the College of American Pathologists (CAP) Proficiency Testing (PT) records, and an interview with the laboratory's technical consultants and the testing person, the laboratory failed to enroll in a PT program that meets the criteria in Subpart I and is approved by HHS for the sub-specialities of bacteriology, mycology, parasitology, general immunology, chemistry and endocrinology, and for the specialty of hematology testing for the 2018 calendar year. FINDINGS: The laboratory's technical consultants and testing person confirmed on June 13 at approximately 4:30 PM, that the laboratory failed to enroll in the 2018 CAP PT program. Approximately 500 patient specimens were tested and results were reported for bacteriology, mycology, parasitology, general immunology, chemistry and endocrinology sub-specialty, and for the hematology specialty testing. 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 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 -- 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 the surveyor's review of proficiency testing (PT) reports and an interview with the technical consultants and the testing person, the laboratory failed to authorize the release of the College of American Pathologists (CAP) PT results for 2019 to the New York State Department of Health's Physician Office Laboratory Evaluation Program (POLEP). FINDINGS: Although the laboratory is enrolled in PT for all specialties for the 2019 calendar year, there was no indication that the laboratory has authorized the PT provider, (CAP), to release results to New York State Department of Health's POLEP Program. -- 2 of 2 --