Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Advanced Dermatology and Cosmetic Surgery on 11/05/2024 . 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 location manager, the laboratory failed to ensure the potassium hydroxide that was used for mycology (fungi) and parasitology (scabies) testing was not expired prior to performing 4 patient tests from 1/15/2024 - 02/06/2024. Findings included: A tour of the laboratory on 11 /05/2024 at 09:15 AM, revealed the expiration date was 2020/07/07 on the bottle of potassium hydroxide (Lot number 1918209) used for mycology (fungi) and parasitology (scabies) testing. A review of the patient fungi and scabies result log revealed 4 tests had been performed after the 07/07/2020 expiration date. The testing was performed on 01/15/2024 (2 tests), and 02/06/2024 ( 2 tests). On 11/05/2024 at 09:40 AM, the Location Manager confirmed the potassium hydroxide was expired and patients were tested. 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 --