Advanced Dermatology Of Pa

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 review of peer review records and interview with the Laboratory Director (LD), the Laboratory failed to ensure that verification of accuracy of the histopathology slides was performed twice annually for 2 of 2 years, from 2021 to 2022 as required. Findings Include: 1. On the day of the survey, 03/01/2023 at 10: 40am, the laboratory could not provide a twice-yearly peer review for the histopathology slides performed in 2021 and 2022. 2. The LD confirmed the findings above on 03/01/2023, around 11:05am. 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 review of quality control (QC) records and interview with the Laboratory Director (LD), the laboratory failed to document Immunohistochemical (IHC) and special stains QC performed on histopathology examinations in 2021 and 2022. 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 -- Findings include: 1. On the day of the survey, 03/01/2023 at 10:10 am., a review of Histopathology tissue staining records revealed that IHC and special stains QC were not documented in 2021 and 2022. 2. The laboratory performed 417 IHC/Specials Stains in 2021 and 253 IHC/ special stains in 2022. 3. The LD confirmed the findings above on 03/01/2023 around 11:05 am. -- 2 of 2 --

Summary Statement of Deficiencies 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 review of the laboratory procedure manuals and interview with the laboratory director (LD), the laboratory failed to establish a written quality assessment (QA) policy to assess ongoing mechanisms to monitor the laboratory systems from 09 /20/2017 to 11/13/2019. Findings Include: 1. On the day of survey, 11/13/2019, review of the laboratory's manuals revealed that the laboratory did not to have a written QA policy to assess the laboratory's pre-analytical to post-analytical systems from 09/20/2017 to 11/13/2019. 2. The LD confirmed the laboratory did not a have quality assessment policy on 11/13/2019 around 09:30 am. 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. 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 -- This STANDARD is not met as evidenced by: Based on the review of patient test reports and interview with the laboratory director (LD), the laboratory failed to indicate the name and address of the laboratory's location where the histopathology slides were examined on the test reports (3 of 3 reviewed). Findings Include: 1. On the day of survey, 11/13/2019, a review of some test reports (3 of 3 reviewed) revealed, the top of the reports state "Skin Pathology Associates" and on the bottom, "Advanced Dermatology of PA, 608 Ederer Lane, Ambler PA 19002". 2. The patient test reports did not clearly state the name of the laboratory and address where the histopathology slides were examined (were the slides examined at the Skin Pathology or at Advanced Dermatology of PA). 3. The LD confirmed the findings above on 11/13/2019 around 09:15 am. -- 2 of 2 --