Lancaster Skin Center Pc

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 the review of the laboratory's procedure manual, peer review records, and interview with the Laboratory Director (LD), the laboratory failed to verify the accuracy of the microscopic examinations for histopathology (Mohs Surgery), at least twice annually as required for tests not included in subpart I in 2022. Findings include: 1. The laboratory's Proficiency Testing Policy (Item #6.1.1) stated that "Mohs slides are reviewed every 6 months (at least 3 cases)." 2. On the day of survey, 05/25 /2023 at 10:46 am, review of Mohs surgery peer review records revealed that evaluation and verification activity was performed for the microscopic examinations for histopathology (Mohs Surgery) once in 2022. 3. The laboratory performed 276 microscopic examinations for histopathology (Mohs Surgery) in 2022. 4. The LD confirmed the findings above on 05/25/2023 around 12:00 pm. 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 D3013 FACILITIES CFR(s): 493.1101(e) Records and, as applicable, slides, blocks, and tissues must be maintained and stored under conditions that ensure proper preservation. This STANDARD is not met as evidenced by: Based on lack of documentation, observation of the laboratory, and interview with the laboratory director (LD), the laboratory failed to monitor the room temperature of paraffin blocks storage to ensure proper conditions for preservation for 2019, 2020 and 2021. Findings include: 1. On the day of survey, 06/15/2021 at 10:11 a.m., the surveyor observed paraffin blocks were stored at room temperature in the histology laboratory and also in a storeroom behind the laboratory. 2. The LD could not provide room temperature records for the following: - Histology laboratory. - Storeroom . 3. The LD confirmed the findings above on 06/15/2021 at 10:45 a.m. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES 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 review of Laboratory procedure manuals and interview with laboratory director (LD), the laboratory failed to establish a complete competency assessment procedure to assess 1 of 2 testing personnel (TP) who performed Potassium Hydroxide (KOH) and scabies examination from 06/15/2019 to the date of survey. Findings include: 1. On the day of survey, 06/15/2021 at 09:32 a.m., the laboratory 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 -- failed to provide a complete written policy that reviews how to assess the competency of 1 of 2 TP performing KOH and scabies examinations in 2019, 2020 and 2021. 2. The LD confirmed the findings above on 06/15/2021 around 10:45 a.m. -- 2 of 2 --