Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Urology Center of South Florida PA on August 11, 2026. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiencies cited are as follows: D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation, record review and interview, the laboratory failed to have open and expiration date on control 1 and control 2 used in urinalysis. Findings Included: 1. On 8/11/2026 at 2:40 PM, the fridge contained control 1 lot 73981 and control 2 lot 73992 in use for urinalysis. The controls had no expiration and open dates. 2. Review of Bio-Rad Quantify Advance Control level 1 and level 2 read, "Once opened this product will be stable for 31 days when stored tightly capped at 2 to 25 Celsius (C)." 3. Review of Quality Control signed by the Laboratory Director on 8/7/2026 noted, "all control vials will be labeled with opening date, expiration date and initials of the person preparing control samples." 4. On 8/11/2026 at 4:26 PM, Testing Personnel A confirmed control 1 and control 2 were not labeled with open and expiration dates. 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 --