Complete Dermatology

Summary Statement of Deficiencies D0000 An announced survey of the laboratory was conducted on 04/09/2025. 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. 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's policies/procedures, test accuracy verification records and staff interview, the laboratory failed to document twice annual test accuracy verification for one of four accuracy verification events in 2023 and 2024. Findings included: 1. Review of laboratory's policy "V. Other: ... B. Proficiency Testing" revealed: "Purpose: Proficiency by a consulting dermatopathologist or another MOHS Surgeon will be done two times a year." 2. Review of laboratory's twice annual test accuracy verification records for 2023 and 2024 revealed the laboratory documented only one test accuracy verification event for 2024 tests. Test accuracy verifications were documented as follows: Event: Documented: 1st event 2023 06/21/2023 2nd event 2023 10/10/2023 Event 2024 01/13/2025 3. In an interview on 04/09/2025 at 1040 hours in the office, the facility's Practice Manager (as indicated on submitted Entrance/Exit Conference document) confirmed the findings. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) (e)(15) Specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, 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 -- analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of laboratory's personnel records, policies/procedures and staff interview, the Laboratory Director failed to specify in writing the responsibilities and duties of four of four personnel employed by the laboratory in 2023 and 2024. Findings included: 1. Review of laboratory's personnel records revealed the laboratory had two employees with multiple positions involved in the testing component of tissue examination, a laboratory director (LD)/clinical consultant and a clinical consultant (CC)/technical supervisor (TS)/general supervisor (GS)/testing person (TP). The laboratory also employed two histotechs for preparation of histology slides, not involved in testing. 2. Further review of the laboratory's personnel records revealed there was no documentation of delegation of specific duties to the individuals employed by the facility. 3. Review of laboratory's policies/procedures in the "Complete Dermatology - Conroe; Laboratory Manual" revealed the policies /procedures did not define the duties and responsibilities of each person employed by the laboratory, nor competency assessment requirements for the consultant (CC) /supervisory (TS/GS)/histotech positions. 4. In an interview on 04/09/2025 at 1040 hours in the office, the facility's Practice Manager (as indicated on submitted Entrance /Exit Conference document) confirmed the findings. -- 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. 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 review of the laboratory policies and records, and confirmed in interview, the laboratory failed to document the competency for the technical supervisor and general supervisor. Findings were: 1. Review of the CMS 209 revealed 1 technical supervisor and 1 general supervisor. 2. Review of the laboratory records revealed no documentation of a policy nor a competency for the technical supervisor or general supervisor. 3. An interview with the director of clinical operations on 10/24/19 at 0930 hours in the exam room confirmed the above findings. She was unaware the laboratory was required to have a competency for the technical supervisor or general supervisor. 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. 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 -- This STANDARD is not met as evidenced by: Based on review of the laboratory records and confirmed in an interview, the laboratory failed to document at least twice annually the accuracy of 1 of 1 tests. (Mohs) Findings were: 1. Review of the laboratory records from 2018-2019 revealed no documentation of the laboratory verifying at least twice annually the accuracy of Mohs for 2018. 2. An interview with the histotech on 10/24/19 at 0950 hours in an exam room confirmed the above findings. She stated that she started late in October 2018 and the laboratory had not started the twice annual accuracy assessment until 2019. 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 the laboratory records, patient test records, and confirmed in interview, the laboratory failed to document the acceptability of the H/E (Hematoxylin and eosin) stain for the Mohs test. Findings were: 1. Review of the laboratory records from 2018-2019 revealed no documentation of the acceptability of the H/E stain for Mohs from 04/22/19-10/22/19. 2. Random review of the laboratory records from 04/22 /19-10/22/19 revealed documentation the laboratory performed patient testing on the following dates. Date Patient ID 10/22/19 MS19-330; MS19-334 10/14/19 MS19-313; MS19-317 09/30/19 MS19-295; MS19-298 09/17/19 MS19-266; MS19-268 08/19/19 MS19-238; MS19-240 08/05/19 MS19-212; MS19-214 07/22/19 MS19-195; MS19- 197 07/09/19 MS19-182 06/24/19 MS19-163; MS19-164 06/03/19 MS19-141; MS19- 145 05/20/19 MS19-135; MS19-138 05/06/19 MS19-122; MS19-126 3. An interview with the histotech on 10/24/19 at 0955 hours in the exam room confirmed the above findings. She stated that their logs changed and the column for the QC slide was overlooked. She also stated that the QC slides were made for each of the above dates. D6117 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(4) The technical supervisor is responsible for establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results. This STANDARD is not met as evidenced by: Based on review of the laboratory records and confirmed in interview, the laboratory director failed to ensure the laboratory documented the acceptability of the H/E (Hematoxylin and eosin) stain for the Mohs test. Refer to D5473 -- 2 of 2 --