Summary:
Summary Statement of Deficiencies D0000 A Recertification Survey was conducted on July 29, 2025 at approximately 3:30 PM. The laboratory was surveyed according to 42 CFR Part 493 Clinical Laboratory Improvement Amendments (CLIA) requirements. Deficiencies were identified 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 facility failed to verify the accuracy of testing at least twice annually for 2 of 2 years reviewed. Findings included: A facility document titled, "Dermatology and Dermatologic Surgery: Dermatopathology," signed by the Laboratory Director (LD) on 07/28/2025, revealed, "Quality control sample cases for diagnostic accuracy are submitted for confirmation twice a year to [another clinical laboratory]." The facility was unable to provide evidence that quality control sample cases were submitted for confirmation twice a year as per facility policy. During an interview on 07/29/2025 at 4:05 PM, the LD stated there had been no reviews performed to verify diagnostic accuracy of testing during the past two years. 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 --