Summary:
Summary Statement of Deficiencies D0000 An onsite announced CLIA recertification survey was conducted at John R Hamill Jr MD PA on 02/28/2024, a laboratory in Hudson, FL. The laboratory is not in compliance with Code of Federal Regulations (CFR) 42, Part 493, Laboratory Requirements. The following is a description of the standard level deficiencies: 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 Laboratory Director, the laboratory failed to ensure the mineral oil that was used for parasitology (Scabies) testing was not expired prior to performing three patient tests from 12/4/23 - 2/20/24. The findings include: A tour of the laboratory on 02/28/24 at 10:10 AM revealed the mineral oil on hand (Lot number 9BF0386) expired February 2004. A review of patient Scabies results revealed three tests had been performed on 12/4/23, 12/18/23, and 02/20/24. (Photographic evidence was obtained) On 02/28/2024 at 12:15 PM, the Laboratory Director confirmed the reagents were expired but stated that the Scabies test is just a preliminary test. After performing the Scabies test, he then looks at the site where specimen collection was performed with a lighted magnifier and then determines treatment. 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 --