Summary:
Summary Statement of Deficiencies D0000 The Ecker Dermatology, PA laboratory was found to be out of compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F.R. part 493) upon completion of the recertification survey performed on April 14, 2026. The following standard-level deficiencies were cited: 493.1254 Maintenance and function checks . D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) (b)(1)(i) Establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(1)(ii) Perform and document the maintenance activities specified in paragraph b(1)(i) of this section. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to perform biannual Histopathology equipment maintenance according to established procedures in 2025. Findings are as follows: 1. The laboratory performed Mohs Micrographic Surgery under the Histopathology specialty as confirmed by the Histotechnician (HT) during a tour of the laboratory at 12:12 p.m. on 4/14/26. 2. A Leica CM 1850 Cryostat was observed as present and available for use for Mohs testing during the tour of the laboratory. 3. The laboratory was required to perform preventative maintenance (PM) every six months as defined in the Cryostat Quality Control Procedure provided by the laboratory. 4. Documentation for biannual PM was found on the Cryostat Maintenance Log for April 2025. Documentation for November 2025 PM was not found. The laboratory was unable to produce this documentation upon request. 5. In an interview at 1:25 p.m., the HT confirmed the above findings and indicated biannual PM was not performed in November 2025. 6. The laboratory performed 154 Mohs Micrographic Histopathology cases between November 2025 and April 2026. . 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 --