Dermsurgery Associates-Sugar Land

Summary Statement of Deficiencies D0000 An onsite survey conducted 05/01/2024 found the laboratory in compliance with 42 CFR Part 493, Requirements for Laboratories. 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. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on a review of the laboratory's submitted CMS 209 form, the laboratory's personnel annual competency records, and confirmed in an interview, the technical supervisor failed to have annual competency assessment documentation for 2 of 2 testing personnel performing high complexity testing in 2023. The findings were: 1. Review of the laboratory's submitted CMS 209 form, signed by the laboratory director on 04/10/2024, revealed the laboratory identified 2 testing personnel performing high complexity testing. 2. Review of the laboratory's personnel annual competency records revealed the technical supervisor failed to have annual competency assessment documentation for 2 of 2 testing personnel performing high complexity testing in 2023. Testing personnel #1 Hired date: October, 2019 Testing personnel #2 Hired date: October, 2019 3. In an interview on 05/01/2024 at 1:38 pm in the laboratory, the director and the southwest regional manager confirmed the above findings. Key: CMS=Center of Medicare and Medicaid Services CMS 209 form=Laboratory Personnel Report (CLIA) 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 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 of Participation in the CLIA program, and recertification is recommended. . D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on the review of the laboratory's policy, QC logs from 1/8/21 to 12/17/21, patient result logs from 1/8/21 to 12/17/21, and confirmed in an interview found the laboratory failed to document stain QC acceptability for 18 of 23 days for one of one stains: T-BLUE. The findings were: 1. Review of the laboratory's policy titled "Frozen Sections Workroom Policy & Procedure Manual" under III, Test Specimens F. Staining Procedures revealed "The routine stain for frozen sections in this Mohs surgery lab is Toludidine Blue, 0.5% aqueous." 2. Further review of the laboratory's policy titled "Frozen Sections Workroom Policy & Procedure Manual" under III, Test Specimens F. Staining Procedures revealed "1. Control Slides...The first frozen section of the day (tumor tissue from the first lesion) serves as the stain control slide. It is checked by the histotechnician first and by the surgeon/pathologist when he/she becomes available." 3. Review of stain QC logs from 1/8/21 to 12/17/21 revealed no documentation of stain QC acceptability for T-Blue by surgeon/pathologist for 18 of 23 days. 1/8/21 1/15/21 1/22/21 1/29/21 2/5/21 3/12/21 3/26/21 4/23/21 5/7/21 5/21 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 -- /21 6/4/21 6/25/21 7/2/21 7/16/21 8/6/21 9/24/21 10/8/21 10/22/21 4. Review of patient result logs for the above dates revealed 64 patients with stain slides. 1/8/21 Case#2021SLN001 Case#2021SLN002 Case#2021SLN003 Case#2021SLN004 Case#2021SLN005 Case#2021SLN006 Case#2021SLN007 Case#2021SLN008 1/15 /21 Case#2021SLP001 Case#2021SLP002 Case#2021SLP003 Case#2021SLP004 1 /22/21 Case#2021SLN009 Case#2021SLN010 1/29/21 Case#2021SLP005 Case#2021SLP006 2/5/21 Case#2021SLN011 Case#2021SLN012 Case#2021SLN013 Case#2021SLN014 3/12/21 Case#2021SLP007 Case#2021SLP008 Case#2021SLP009 Case#2021SLP010 3/26/21 Case#2021SLN015 Case#2021SLN016 Case#2021SLN017 Case#2021SLN018 Case#2021SLN019 4/23/21 Case#2021SLP011 Case#2021SLP012 Case#2021SLP013 Case#2021SLP014 5/7/21 Case#2021SLN020 Case#2021SLN021 Case#2021SLN022 Case#2021SLN023 Case#2021SLN024 Case#2021SLN025 5/21 /21 Case#2021SLP015 Case#2021SLP016 Case#2021SLP017 Case#2021SLP018 Case#2021SLP019 6/4/21 Case#2021SLN026 Case#2021SLN027 Case#2021SLN028 Case#2021SLN029 6/25/21 Case#2021SLP020 Case#2021SLP021 Case#2021SLP022 7/2/21 Case#2021SLN030 Case#2021SLN031 Case#2021SLN032 Case#2021SLN033 7/16/21 Case#2021SLP023 8/6/21 Case#2021SLP024 9/24/21 Case#2021SLN034 10/8/21 Case#2021SLN035 Case#2021SLN036 Case#2021SLN037 10/22/21 Case#2021SLP029 Case#2021SLP030 Case#2021SLP031 Case#2021SLP032 5. An interview with the operation director on 5/5/22 at 10:40 am in the office confirmed the above findings. Key: QC=Quality Control T-Blue=Toluidine Blue Stain -- 2 of 2 --

Summary Statement of Deficiencies D0000 Noted deficiency and plans of correction were discussed with the laboratory representative at the entrance and exit conferences. The facility representative was given an opportunity to provide evidence of compliance with the noted deficiency, 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