Seaside Dermatology, Pa

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) (d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on records review and staff interview, the laboratory failed to have documentation of the laboratory director's review and approval of the procedure manual in use. Findings included: 1. Review of procedure documentation reveals the use of a publication " CLIA Manual, A Guide for Dermatology Practices" in use as the procedure manual for the laboratory. 2. The above mentioned procedure manual lacked the signature and date of approval by the labotaory director. 3. In an interview with the practice manager on July 20, 2026 at 1:00pm in the laboratory office, the findings were confirmed. 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 was initiated on 06/05/2023 and concluded on 06/05/2023. The facility was found not to be in compliance with the laboratory requirements of 42 CFR Part 493 with deficiencies cited. 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 document review and interview, it was determined that Mohs examinations were not included in the list of tests or procedures in subpart I of the CLIA regulations. Therefore, they were subject to the requirements for accuracy verification twice annually. The accuracy of the Mohs examinations was being evaluated once annually. Findings included: A review of a laboratory "Procedure and Form 10: Mohs Surgery" document, signed by the Laboratory Director (LD) on 06/26/2020, revealed it lacked a procedure for performing the required twice-annual accuracy verification of Mohs examinations. A review of the laboratory manual revealed it contained instructions from the "American Society for Mohs Surgery," dated January 2022, for submitting case reviews. The instructions indicated a case was to be submitted once per year. Also included in the procedure manual were the results from a single case review performed for 2022. During an interview on 06/05/2023 at 11:30 PM, the LD stated she was unaware of the requirement for twice-annual accuracy verification for the performance of Mohs examinations. 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 --