David Saperstein, Md

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on lack of accuracy verification documentation for review and interview with the laboratory director, the laboratory failed to verify the accuracy of testing performed under the sub-specialty of Histopathology at least twice annually during 2020 and 2021. Findings include: 1. No documentation was presented for review during the survey conducted on February 9, 2022 to indicate the laboratory verified the accuracy of the microscopic interpretation (reading) of histopathology specimens at least twice annually during 2020 and 2021. 2. The laboratory director confirmed that the laboratory failed to verify the accuracy of histopathology testing at least twice annually during 2020 and 2021. 3. The laboratory's approximate annual test volume under the sub-specialty of Histopathology is 350. 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 lack of written Quality Assessment policies and procedures and interview with the laboratory director, the laboratory failed to establish policies and procedures 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 -- related to accuracy verification for histopathology testing performed by the laboratory. Findings include: 1. The laboratory performs testing under the sub- specialty of Histopathology, with an approximate annual test volume of 350. 2. No documentation was presented during the survey to indicate the laboratory had established policies and procedures related to the verification of accuracy process for the testing indicated above, including but not limited to, information specific to the frequency of the review, number of cases reviewed, individual or laboratory performing the review and a remedial action plan in the event of a noted discrepancy. 3. The laboratory director confirmed that the laboratory failed to have an established written policy in place at the time of the survey conducted on February 9, 2022, specific to the verification of accuracy process for histopathology testing performed by the laboratory. -- 2 of 2 --

Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of patient test reports and interview with the laboratory director, the laboratory failed to include on the test report the laboratory name and address where the testing was performed. Findings include: 1. The laboratory performs patient testing in the subspecialty of histopathology with an approximate annual test volume of 500. 2. Two out of two test reports reviewed during the survey (NDX19-0048 and NDX19-0049) were missing the laboratory name and address where the testing was performed. 3. The laboratory director confirmed that the laboratory name and address was not indicated on the test reports referenced above. 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 --