Southeastern Dermatology Group Pa

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Southeastern Dermatology Group PA on 01/10/23. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level 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 record review and interview with the Laboratory Director, the laboratory failed to verify the accuracy of histopathology testing twice annually for one (2022) of two years reviewed (2020 - 2022) for one of one Testing Personnel. Findings included: Record review of the Laboratory Personnel Report (Form CMS 209) completed and signed by the Laboratory Director on 1/10/2023 revealed that the Laboratory Director was also the only Testing Person. Record review of twice annual verification of accuracy of histopathology testing revealed no documentation or evidence of 2022 for the Laboratory Director/Testing Person had been performed. Record review of the laboratory's procedure "Proficiency Testing Policy and Anatomic Pathology Education Programs" revealed "Every 6 months the lab sends 20 cases for review by a dermatopathologist other than the original pathologist." On 01/10 /2023 at 10:35 AM, the Laboratory Director stated the January 2022 - June 2022 histopathology cases were sent for verification of accuracy to another doctor in April of 2022, but the doctor had not sent back his review. The Laboratory Director stated that the July 2022 - December 2022 histopathology cases had not been sent to another doctor for review as of the time of survey (1/10/23). 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 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Southeastern Dermatology on 06/16/20. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level 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 record review and interview with the Laboratory Director the laboratory failed to have the address of where the testing was performed documented on the test report for 2 (2018-2020) out of 2 years reviewed. Findings Included: Review of 3 final reports dated 02/19/20, 04/23/19, and 06/28/18, revealed that the location where the slides were read was not on the final report. Interview on 06/16/20 at 11:30 AM with the Laboratory Director confirmed that the location of where the Histopathology slides were read was not on the final report. 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 --

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 record review and interview with the Laboratory Director, the laboratory failed to have documentation that the accuracy of testing was verified every 6 months since December 2016. Findings Included: Review of peer reviews revealed they were last performed in December of 2016. No other peer reviews were provided. During an interview on 05/21/18 at 11:09 AM the Laboratory Director confirmed that there was no other documentation of peer reviews that verified the accuracy of testing. D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on record review and interview with the Laboratory Director the laboratory failed to record the quality control (QC) for the differential staining, special stains, and immunohistochemical staining since at least February 2017. Findings Included: Review of QC records revealed no documentation of QC for the differential, special, 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 -- and immunohistochemical staining. During an interview on 05/21/18 at 11:09 AM the Laboratory Director confirmed that the QC for the staining was not recorded. -- 2 of 2 --