Summary:
Summary Statement of Deficiencies 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 review of laboratory records, lack of documentation, and interview with the laboratory representative; the laboratory failed to perform biannual method accuracy (proficiency testing/peer reviewed histopathology interpretations) for dermatopathology slide interpretations in the year of 2025. Findings include: 1. Review of laboratory records revealed a lack of biannual method accuracy documentation at least twice annually for dermatopathology slide interpretations in the year of 2025. 2. Interview with the laboratory representative on 04/21/2026, at 10: 05 am, confirmed the laboratory failed to perform biannual method accuracy (proficiency testing/peer reviewed histopathology interpretations) for dermatopathology slide interpretations in the year of 2025. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) (e)(12) Ensure that prior to testing patients specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results; This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records, lack of documentation, and interview with the laboratory representative; the laboratory Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- director (LD) failed to ensure that prior to testing patients' specimens, one of two testing personnel (TP) performing dermatopathology slide interpretations demonstrated competency that they can perform all testing operations reliably to provide and report accurate results in the subspecialty of histopathology. Findings include: 1. Review of laboratory policies and procedures revealed the policy titled "Job Description: Lab Director", which stated, "[The LD] evaluates regulatory competence of all testing and lab personnel". 2. Review of laboratory records revealed the laboratory lacked competency assessments for dermatopathology slide interpretations in the year of 2025. 3. Review of laboratory records revealed the laboratory failed to perform biannual method accuracy for dermatopathology slide interpretations in the year of 2025 (see D5217). 4. Interview with the laboratory representative on 04/21/2026, at 10:05 am, confirmed the LD failed to ensure that prior to testing patients' specimens, one of two testing personnel (TP) performing dermatopathology slide interpretations demonstrated competency that they can perform all testing operations reliably to provide and report accurate results in the subspecialty of histopathology. -- 2 of 2 --