Skin Pathology Center Inc

Summary Statement of Deficiencies D0000 A recertification survey was conducted from January 16, 2025 to January 21, 2025. SKIN PATHOLOGY CENTER INC clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. 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. This STANDARD is not met as evidenced by: Based on observation, record review, and staff interview the laboratory failed to document quality control activities in the Histopathology laboratory for two random samples in April and August of 2023, out of two years (2023 and 2024) reviewed. The findings included: 1-Review of the daily Skin Pathology Center (SPC) Quality Control (QC) Form for slides dated 04/10/2023 and signed by the laboratory director (Dermatopathologist) on 04/11/2023, did not include positive or negative controls for the random sample received on 04/10/2023 and reported on 04/12/2023. 2- Review of the daily SPC QC Form revealed that there were no QC records, positive or negative controls, for the random sample received on 8/22/2023 and reported on 08/29/2023. 3- Review of the daily "SPC ACCESSION LOG" listed the random patients on 04/3 /2023 and 8/21/2023. 4--Review of the SPC Daily QC procedure stated in step 3. The laboratory will maintain the records of the QC sheets..." 5-Interview on 01/16/2024 at 02:42 PM with the Laboratory Director confirmed that the QC records were missing for two random patients reviewed. 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 A recertification survey conducted on 01/12/2023 found the SKIN PATHOLOGY CENTER INC clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories 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 laboratory consultant interview, the laboratory failed to ensure the twice a year accuracy verification for histopathology testing for two out of two years reviewed. Findings include: -Peer review records revealed that the laboratory documented a peer review on 03/04/2021, no other records found for 2021 and for 2022 no records found. -During an interview on 01/12/2023 at 9:30 AM, the laboratory consultant confirmed that the laboratory failed to have documentation of twice a year accuracy verification for histopathology during 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 1 --