Pinski Dermatology & Cosmetic Surgery

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 laboratory records, lack of documentation, and interview with laboratory representative; the laboratory failed to perform biannual method accuracy (proficiency testing/peer reviewed histopathology interpretations) for dermatopathology for two of two years reviewed, 2024 and 2025. Findings include: 1. Review of laboratory records revealed the laboratory sent slides out for peer review one time each year for dermatopathology interpretations in 2024 and 2025. Date(s) of testing: Date of review: 01/12/2024 - 12/16/2024 01/29/2025 01/27/2025 - 10/01/2025 11/05/2025 2. Interview with the laboratory representative on 12/16/2025, at 1:57 pm, confirmed the laboratory failed to perform biannual method accuracy (proficiency testing/peer reviewed histopathology interpretations) for dermatopathology for two of two years reviewed, 2024 and 2025. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of laboratory records, lack of documentation, and interview with the laboratory representative; the laboratory failed to evaluate/review results of biannual method accuracy (proficiency testing/peer reviewed histopathology interpretations) for two of two dermatopathology events performed in 2024 and 2025. Findings 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 -- include: 1. Review of laboratory records revealed the laboratory failed to evaluate peer reviewed dermatopathology interpretations in 2024 and 2025. Date(s) of testing: Date of review: 01/12/2024 - 12/16/2024 01/29/2025 01/27/2025 - 10/01/2025 11/05 /2025 2. Interview with the laboratory representative on 12/16/2025, at 1:57 pm, confirmed the laboratory failed to evaluate/review results of biannual method accuracy (proficiency testing/peer reviewed histopathology interpretations) for the above two dermatopathology peer reviews in 2024 and 2025. -- 2 of 2 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of laboratory records, patient records, direct observation, and interview with lead medical assistant (MA), the laboratory failed to retain handwritten slide interpretation results for two of two patient records reviewed in 2020 and 2021. Findings Include: 1. Surveyor review of the laboratory procedures manual for all tissue specimens at Pinski Dermatology and Cosmetic Surgery revealed, "We use a 'sticky' sheet for each slide that is to be read by the provider. On that sheet is the patient's name, biopsy number, slide number, box number and the plate number (see example #1). Dr. X then reviews the slides carefully with accuracy and proficiency and assigns a corresponding plate number (see example #2)." 2. Surveyor review of two of two patient records revealed the laboratory failed to maintain records of the "sticky" sheets described in Finding 1. a. Patient 1 - Medical Record Number 33780, 11/09/2020 b. Patient 2 - Medical Record Number 131080, 01/05/2021 3. Surveyor interview with MA on 10/28/2022 at 1:00 p.m. revealed, the laboratory makes a 'sticky' for the doctor to read and result patient slides. The 'sticky' is then given to the MA with the doctors handwritten results to be entered into the laboratory's information system. The sticky note is then shredded. 4. Surveyor observation on 10 /28/2022 at 1:24 p.m., revealed the medical assistant shredding one of one 'sticky' sheets described in Finding 1 after entering patient interpretive slide results into the laboratory's information system. 5. On 10/28/2022 at 1:24 p.m., the MA confirmed the above findings. 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 records review, manual, and an interview with the office staff, the laboratory failed to verify the accuracy of the Histopathology testing the laboratory performs for the years of 2018 and 2019. Findings include: 1. American Society For Mohs Surgery (ASMS) Peer reviews, patients' test reports, and laboratory manual were reviewed. 2. The patients' test reports revealed that the laboratory had been performing Mohs surgery procedures during the years of 2018 and 2019. 3. The documentation showed that the last ASMS Peer Review in which the Mohs surgeon participated was dated 06 /28/2017. 4. The laboratory's failed to participate in the ASMS Peer Reviews biannually to verify the accuracy it's Mohs surgery procedure for the years of 2018 and 2019 5. On a Recertification survey conducted on 11/22/2019 at 11:45 AM, the office staff confirmed the above findings. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on direct observation, record review, and an interview with the office staff, the 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 -- laboratory failed to follow written procedures for the Hematoxylin and Eosin (H&E) staining, affecting 6 out of 6 patients. Findings include: 1. The laboratory procedures manual, the patients' test logs and their H&E stained slides were reviewed. 2. The testing personnel is required to document the source of the tissue on the slide that is to be processed for H&E staining. 3. The H&E slides from the following dates were reviewed: 02/26/2018, 07/30/2018, 10/29/2018, 01/21/2019, 06/24/2019, and 09/30 /2019. 4. The patients' test log and H&E slides showed the tissue sites for 6 out of 6 patients were not written on their respective slides. 5. On a Recertification survey conducted on 11/22/2019 at 11:45 AM, the office staff confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies No Tags No deficiency details available. 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 --