Southeast Texas Dermatology

Summary Statement of Deficiencies D0000 The laboratory was found to be in compliance with 42 CFR Part 493, Requirements for Laboratories as a result of a recertification survey on March 25, 2025. 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 procedures, laboratory documentation, and confirmed in interview the laboratory failed to participate in twice annual accuracy assessment for two of two high complexity laboratory tests performed, MOHS surgical grossing and slide interpretation, for records reviewed in 2023 and 2024. The findings included: 1. Review of the laboratory procedure titled "Proficiency Testing" included the following instructions: "Semi-annually, the tech or Risk Manager will send two cases containing the original slides, label it with only the surgical case number, and send it our [sic] for a microscopic examination by a Board Certified Dermatopathologist ... Upon receipt of the pathology report from the Dermatopathologist, diagnosis of the slide specimen will be matched to the in-house diagnosis by the physician ... Results of each Proficiency Test will be entered in a log and kept in the laboratory management manual, as part of its permanent records." 2. Surveyor asked for documentation that a twice annual accuracy assessment for MOHS surgical grossing and slide interpretation, and none could be provided. 3. In an interview on 3/25/2025 at 13:02, over the phone and in the presence of the office manager in the laboratory, the laboratory director confirmed the laboratory had not participated in a twice annual accuracy assessment for testing performed in the laboratory in 2023 and 2024. 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 --

Summary Statement of Deficiencies D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of policies and procedures, quality control records, patient test records, and interview of facility personnel, the laboratory failed to document the negative and positive reactivity of quality control slides for Hematoxylin and Eosin (H and E) staining on 10 of 10 days patient testing was done between September 7, 2022 and March 18, 2023. The findings included: 1. Review of the policy titled QUALITY ASSURANCE FOR ROUTINE STAINS found: "A quality control slide will be run each day the lab operates. The QC (quality control) slide will be for Hematoxylin and Eosin or Toluidine blue. Whichever is used in the lab. The QC for the H&E will be of normal skin, have a crisp blue nuclei and counter stain with light pink cytoplasm. The T-blue will again be with normal skin, crisp blue nuclei and light blue to purple counter stain. The lab director will determine whether the stain is acceptable for the day. Each QC will be logged on the stain QC chart." 2. Based on review of H and E stain quality control logs between September 7, 2022 and March 18, 2023 the laboratory failed to document the stain reactivity on 10 of 10 days patient specimens were tested between September 7, 2022 and March 18, 2023. 2. Based on review of 10 of 67 patient test records between September 7, 2022 and March 18, 2023, The laboratory did not document assessment of stain acceptability or positive and negative reactivity, in 10 of 10 cases. 3. During interview of the Mohs Technician conducted April 25, 2023 at 2:09 PM she confirmed the physicians do not document, quality or acceptability of staining on the quality control logs. 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 --