Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Palm Harbor Dermatology PA dba PHDermatology Lutz on 1/08/2026. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiencies cited are as follows: D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) (d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of laboratory procedure manual, record review, and interview, the laboratory procedures failed to be approved, signed, and dated by the current Laboratory Director from 11/3/2025 to 1/08/2026. Findings included: 1. The laboratory policies and procedures manual last documented review and approval was by the prior Laboratory Director on 1/1/2025. 2. The Quarterly Management Assessment Checklist for November-December 2025 was signed by the current Laboratory Director on 12/18/2025 and included a "y" (yes) for the line item "All procedures are approved, signed, and dated by the laboratory director." 3. The Vice President of Operation on 1/8/2026 stated at 10:00 a.m., the current Laboratory Director had begun directorship on 11/3/2025 and the laboratory procedure manual had not been approved, signed, and dated by the current Laboratory Director from 11/3 /2025 to 1/08/2026 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 --