Summary:
Summary Statement of Deficiencies D0000 An on-site announced CLIA recertification survey was conducted at Bracciano Dermatology PLC on 05/13/2024. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiency: D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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 interview with the office manager, the laboratory failed to ensure the Scott's Tap Water Substitute (Lot number 2310024) used for histopathology (hematoxylin and eosin stain) testing was not expired prior to performing 40 patient tests from 04/20/2024 - 05/10/2024. Findings included: A tour of the laboratory on 05/13/2024 at 1:15 PM revealed an expiration date of 04/20/2024 on the container of Scott's Tap Water Substitute (Lot number 2310024)) used for hematoxylin and eosin testing. A review of the patient micrographically oriented histographic surgery (Mohs) log revealed 40 tests had been performed after the 04/20 /2024 expiration date. The testing was performed on 04/26/24 (12 tests), 05/03/24 (14 tests), and 05/10/24 (14 tests). On 05/13/2024 at 1:30 PM, the Office Manager confirmed patients were tested using the expired reagent. 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 --