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 accuracy verification documentation for the microscopic interpretation of Frozen Excision specimens and Mohs specimens and interview with the facility personnel on 5/26/26 at 11:08 AM, the laboratory failed to verify the accuracy of Frozen Excision and Mohs testing performed under the subspecialty of Histopathology at least twice annually during 2025. Findings include: 1. No documentation was presented for review to indicate the laboratory verified the accuracy of the microscopic interpretation of Frozen Excision specimens and Mohs specimens at least twice annually during 2025. 2. The facility personnel interviewed on 5/26/26 at 11:08 AM confirmed the laboratory failed to verify the accuracy of histopathology testing at least twice annually during 2025. 3. The laboratory reports an annual test volume of 40 performed under the subspecialty of Histopathology. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of Quality Assessment (QA) records and interview with the facility 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 -- personnel on 5/26/26 at 11:17 AM, the laboratory failed to perform and document monthly QA activities from March 2025 through April 2026. Findings include: 1. The laboratory began patient testing on 3/21/25 in the subspecialty of Histopathology with a reported annual test volume of 40. The laboratory performs the microscopic interpretation of Mohs specimens and Frozen Excisions. 2. The laboratory's QA practices include performing and documenting a Monthly QA checklist and performing and documenting a Monthly Patient QA checklist. 3. The "Monthly Quality Assurance Checklist" is a checklist used to monitor, ensure completion, and document