Bayou City Dermatology

Summary Statement of Deficiencies D0000 A recertified onsite survey was completed on 09/12/2025. Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions in the CLIA program, and recertification is recommended. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on the review of the laboratory's CMS 209 Laboratory Personnel Report, the laboratory's records, personnel competency records, and confirmed in an interview, the laboratory failed to have documentation of competency assessment for 1 of 1 clinical consultants, 1 of 1 technical supervisor, and 1 of 1 general supervisor. The findings were: 1. Review of the laboratory's records reveal no policy available for personnel competency assessment. 2. Review of the laboratory's CMS 209 Laboratory Personnel Report, signed by the laboratory director on 09/08/2025, revealed the laboratory identified 1 clinical consultant, 1 technical supervisor and 1 general supervisors. 3. Review of the laboratory's personnel competency records revealed the laboratory failed to have documentation of competency assessment for 1 of 1 clinical consultants, 1 of 1 technical supervisor, and 1 of 1 general supervisor. Clinical consultant, technical supervisor, and general supervisor: Hired date: December, 2020 4. In an interview on 09/12/2025 at 12:10 pm in the lab, the practice administration confirmed the above findings. Key: CMS=Center of Medicare and Medicaid Services D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) 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 -- (b)(9) Evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on the review of the laboratory's CMS 209, the laboratory's personnel competency records, and confirmed in an interview, the technical supervisor failed to have documentation of testing personnel for the 1st year competency assessment for 1 of 3 testing personnel. The findings were: 1. Review of CMS 209 form Laboratory Personnel Report (CLIA), signed by the laboratory director on 09/08/2025, revealed the laboratory identified 3 testing personnel performing high complexity tests. 2. Review of the laboratory's personnel competency records revealed the technical supervisor failed to have documentation of 1st year competency assessment documentation for 1 of 3 testing personnel performing high complexity testing. Testing personnel #2 Hired date: 04/26/2023 3. An interview on 09/12/2025 at 11:45 am in the lab, the practice administration confirmed the above findings. Key: CMS=Center of Medicare and Medicaid Services -- 2 of 2 --

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions in the CLIA program, and recertification is recommended. D6143 GENERAL SUPERVISOR QUALIFICATIONS CFR(s): 493.1461 (a) The general supervisor must possess a current license issued by the State in which the laboratory is located, if such licensing is required; and (b) The general supervisor must be qualified as a-- (b)(1) Laboratory director under 493.1443; or (b)(2) Technical supervisor under 493.1449. (c) If the requirements of paragraph (b)(1) or paragraph (b)(2) of this section are not met, the individual functioning as the general supervisor must-- (c)(1)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; and (c)(1)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing; or (c)(2)(i) Qualify as testing personnel under 493.1489(b)(2); and (c)(2)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing; or (c)(3)(i) Except as specified in paragraph (3)(ii) of this section, have previously qualified as a general supervisor under 493.1462 on or before February 28, 1992. (c)(3)(ii) Exception. An individual who achieved a satisfactory grade in a proficiency examination for technologist given by HHS between March 1, 1986 and December 31, 1987, qualifies as a general supervisor if he or she meets the requirements of 493. 1462 on or before January 1, 1994. (c)(4) On or before September 1, 1992, have served as a general supervisor of high complexity testing and as of April 24, 1995-- (c) (4)(i) Meet one of the following requirements: (c)(4)(i)(A) Have graduated from a medical laboratory or clinical laboratory training program approved or accredited by the Accrediting Bureau of Health Education Schools (ABHES), the Commission on Allied Health Education Accreditation (CAHEA), or other organization approved by 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 -- HHS. (c)(4)(i)(B) Be a high school graduate or equivalent and have successfully completed an official U.S. military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician). (c)(4)(ii) Have at least 2 years of clinical laboratory training, or experience, or both, in high complexity testing; or (c) (5) On or before September 1, 1992, have served as a general supervisor of high complexity testing and-- (c)(5)(i) Be a high school graduate or equivalent; and (c)(5) (ii) Have had at least 10 years of laboratory training or experience, or both, in high complexity testing, including at least 6 years of supervisory experience between September 1, 1982 and September 1, 1992. (d) For blood gas analysis, the individual providing general supervision must-- (d)(1) Be qualified under 493.1461(b)(1) or (2), or 493.1461(c); or (d)(2)(i) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; and (d)(2)(ii) Have at least one year of laboratory training or experience, or both, in blood gas analysis; or (d)(3) (i) Have earned an associate degree related to pulmonary function from an accredited institution; and (d)(3)(ii) Have at least two years of training or experience, or both in blood gas analysis. (e) The general supervisor requirement is met in histopathology, oral pathology, dermatopathology, and ophthalmic pathology because all tests and examinations, must be performed: (e)(1) In histopathology, by an individual who is qualified as a technical supervisor under 493.1449(b) or 493.1449(l)(1); (e)(2) In dermatopathology, by an individual who is qualified as a technical supervisor under 493.1449(b) or 493.1449(l) or (2); (e)(3) In ophthalmic pathology, by an individual who is qualified as a technical supervisor under 493.1449(b) or 493.1449(1)(3); and (e)(4) In oral pathology, by an individual who is qualified as a technical supervisor under 493.1449(b) or 493.1449(m). This STANDARD is not met as evidenced by: Based on the review of patient reports from 7/21/2023 to 11/11/2023 and confirmed in an interview, the laboratory failed to document the TS review within 24 hours for all physical examinations/description, including color, weight, measurement and other characteristics of the tissues; or other mechanical procedures for 10 of 10 patient reports reviewed. The findings were: 1. An interview with the TP1 confirmed the TP1 started grossing in July 2023. 2. Random review of patient reports from 7/21/2023 to 11/11/2023 revealed TP1 grossed 10 of 10 patients reviewed. 3. Further review of laboratory records revealed no documentation of the TS review within 24 hours for all physical examinations/description, including color, weight, measurement and other characteristics of the tissues; or other mechanical procedures for 10 of 10 patient reports reviewed. 7/21/23 Case# WW23-W283 7/26/23 Case# WW23-W314 7/27/23 Case# WW23-W324 8/21/23 Case# WW23-W358 8/23/23 Case# WW23-W365 9/29 /23 Case# WW23-W426 9/30/23 Case# WW23-W441 10/5/23 Case# WW23-W466 10/6/23 Case# WW23-W478 11/11/23 Case# WW23-W570 4. Review of CMS 209 Laboratory Personnel Report signed by the laboratory director (LD) on 11/29/2023 revealed TP1 is not qualified as a TS. 5 An interviewed with the practice administrator on 11/30/2023 at 12:20 pm in the lab confirmed the above findings. Key: TS=Technical supervisor TP=Testing personnel CMS=Centers for Medicare and Medicaid -- 2 of 2 --

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. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the