Bayou City Dermatology

Summary Statement of Deficiencies D0000 An announced survey of the laboratory was conducted on 06/27/2025. The laboratory was found in compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories) for the specialties/subspecialties for which it was surveyed. STANDARD LEVEL DEFICIENCIES were cited. D5787 TEST RECORDS CFR(s): 493.1283(a) (a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on review of laboratory's submitted Form CMS 209, laboratory's test records and staff interview, the laboratory failed to document the identity of the personnel performing gross tissue examination for two of two patients' Mohs surgery test records reviewed from March and May 2025. Findings included: 1. Review of laboratory's submitted Form CMS 209 revealed 3 testing personnel performed testing on patients' Mohs surgery tissue. 2. In an interview on 06/27/2025 at 1008 hours in the laboratory, the facility's Practice Administrator (as indicated on submitted Entrance /Exit Conference Document), when asked, stated that all three personnel listed on CMS 209 performed gross examinations of the patients' tissue samples. 3. Review of random laboratory's patient Mohs surgery test records (patient reports and Mohs maps) from March and May 2025 revealed the laboratory did not document the identity of the personnel performing gross tissue examination for two of two test 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 -- records reviewed. The reviewed records were: Case: Tested: WW25-C23 03/01/2025 WW25-C53 05/16/2025 4. In an interview on 06/27/2025 at 1008 hours in the laboratory, the facility's Practice Administrator confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The laboratory was found out of compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories). The facility representative was given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found in compliance with applicable CLIA conditions, and recertification is recommended. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)