Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Shah Shareef DO DBA Coral Dermatology on 09/15/2025. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. The Standard deficiency cited was as follows: D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to verify accuracy twice annually from 1/16/24 to 09/15/25 for Testing Person (TP) A , the only testing personnel, for testing performed in the subspecialty of Histopathology. Findings included: 1. The laboratory's Policies and Procedure Manual reviewed and signed by the Laboratory Director on 1/06/2025 showed semi-annually, two cases would be randomly selected to be submitted to a board certified dermatologist for review in the absence of an accredited proficiency testing program. 2. The CMS-209 signed by the Laboratory Director on 09/17/25 listed only himself as TP A. 3. Quality Assurance- Proficiency records were reviewed from 1/16/24 to 09/15/25, the only QA-Proficiency records found was dated 1/23/2025 for TP A. 4. The Laboratory Director on 09/15/25 at 12:05 p.m., confirmed the twice yearly verification of Histopathology testing failed to be performed and that the only verification completed was dated 1/23/2025. 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 --