Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Beaches Dermatology, Pa on 12/23/25. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation, record review, and staff interview, the laboratory failed to ensure that reagents were not used after their expiration date for Gill's Hematoxylin III. This failure resulted in the usage of expired reagent for approximately 50 patients between December 1, 2025, and December 23, 2025 The findings include: 1. Observation of laboratory reagents on 12/23/25 identified an open bottle of Gill's Hematoxylin III (lot number 212840) stored in the flammable cabinet with a manufacturer's expiration date of 2025-11-30. 2. Review of the laboratory document titled "Reagent Receipt Log" confirmed that lot number 212840 was opened for use on 4/28/25. The log also showed the laboratory had an unopened bottle of the same reagent (lot number 241901) with a valid expiration date of 11/30/26. 3. During an interview with the Mohs technician (MT1) on 12/23/25 at 10:00 AM, it was confirmed that lot number 212840 was the only open bottle of Hematoxylin in the laboratory and that it had been used for approximately 50 patients while in an expired state. 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 --