Surgical Dermatology Associates

Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations 42 CFR Part 493. Standard level deficiencies were cited. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individuals 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 review of laboratory policy, personnel records, and confirmed in staff interview, the technical supervisor failed to evaluate and document annual competency assessments for two of two testing persons (TP-1 and TP-2) responsible for high complexity testing in 2023 and 2024. Findings included: 1. Review of laboratory policy titled "JOB DESCRIPTION" stated: "JOB TITLE: Technical Supervisor DUTIES AND RESPONSIBILITIES: Listed but not limited to ... 4. Daily responsibilities that may be delegated to the Lab Manager ... d. Evaluate and document the performance of all testing personnel" 2. Review of personnel records revealed the technical supervisor failed to evaluate and document annual competency assessment for TP-1 and TP-2 in 2023 and 2024. 3. During an interview on 05/28 /2025 at 10:12 a.m., the Laboratory Manager, confirmed the technical supervisor failed to evaluate and document annual competency assessments for two of two testing persons (TP-1 and TP-2) responsible for high complexity testing 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 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 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 A recertification survey was conducted on 08/11/2021. The laboratory was found to be in substantial compliance for the specialties/subspecialties for which it was surveyed. Standard level deficiencies were cited. D3013 FACILITIES CFR(s): 493.1101(e) Records and, as applicable, slides, blocks, and tissues must be maintained and stored under conditions that ensure proper preservation. This STANDARD is not met as evidenced by: Based on direct observation, review of temperature/humidity logs, and in interview with staff, the laboratory failed to have a system in place to ensure slides were maintained under proper preservation conditions for 2019, 2020, and 2021. Findings included: 1. During a tour of the clinic on 08/11/2021 at 2:45 pm, filing cabinets with slides from previous Mohs cases were observed to be stored in a closed room. There was no mechanism observed to monitor storage conditions in the room. 2. Review of temperature/humidity logs from 2019 through 2021 did not include documentation of the room in which slides were stored to ensure proper preservation of those conditions. 3. During an interview on 08/11/2021 at 3:45 pm, the laboratory manager confirmed the room with slides was not monitored or documented for storage conditions. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. 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: I. Based on review of the laboratory's procedure manual, cryostat preventative maintenance (PM) records, and in interview with staff, the laboratory failed to follow their own written policy for ensuring cryostat PM was performed and documented every 6 months for 2020 and 2021. Findings included: 1. Review of the laboratory's "Quality Control Policies and Documentation" stated, "Cryostat: 10. Preventative maintenance and grounding checks are done 6 months." 2. Cryostat records revealed the laboratory had documentation of PM for two (2) Leica CM1510S (serial numbers: 6198 and 6258) completed: 07/30/2020 and 07/20/2021. The laboratory did not have PM documentation for 01/2020 and 01/2021 for the cryostats (6 months), per their written policy. 3. During an interview on 08/11/2021 at 3:50 pm, the laboratory manager reviewed and confirmed the above findings. II. Based on review of the laboratory's procedure manual, Linistain Stainer reagent logs, and in interview with staff, the laboratory failed to follow their own written policy for changing reagents on the Linistain Stainer (Hematoxylin, Eosin and Xylene) for 7 of 7 months reviewed from 10/2020 through 05/2021. Findings included: 1. Review of the laboratory's "Hematoxylin and Eosin Stain" policy for reagent schedule stated, "Changed Weekly: Eosin and Xylene substitute; Change Monthly: Hematoxylin...This Protocol implemented on 08/24/2015." The "Quality Control Record for Mohs Lab: Linistain STAINER" stated, "Hematoxylin and Eosin are changed monthly...(Updated 10/19)." The laboratory protocols were not consistent with one another. 2. Review of the "Quality Control Record for Mohs Lab: Linistain STAINER" records from 10/2020 through 05/2021 revealed the following: 11/2020, 12/2020, 01/2021, 02/2021, 03 /2021, 04/2021, and 05/2021 did not have documentation ("c - changed") that the Hematoxylin was changed monthly per the laboratory's protocol. The last documentation that Hematoxylin was changed was on 10/19/2020. 11/2020, 12/2020, 01/2021, 02/2021, 03/2021, 04/2021, and 05/2021 did not have documentation ("c - changed") that the Eosin and Xylene were changed weekly per the laboratory's protocol ("Hematoxylin and Eosin Stain"). The last documentation that Eosin and Xylene were changed was on 10/19/2020. 3. During an interview on 08/11/2021 at 3: 50 pm, the laboratory manager reviewed the above findings and confirmed when she changed the reagents she did not indicate that on the "Quality Control Record for Mohs Lab: Linistain STAINER" form. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance for the specialties /subspecialties for which it was surveyed. Exit conference was held with the laboratory manager on 10/08/2019. The standard level deficiency cited was discussed. The process for submitting the corrections was explained. CMS form 2567 will be emailed from the Texas Health and Human Services Commission, Patient Quality Arlington Group. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on direct observation and in interview with staff, the laboratory failed to ensure histopathology reagents were not beyond their expiration date. Findings included: 1. During a tour of the laboratory on 10/08/2019 at 2:10 pm, the following reagents were observed to be stored in a cabinet: Vintage Bluing Reagent (1 Gallon) Lot #30167 expiration date 05/17 HistoPrep Xylenes (1 Gallon) Lot #146468 expiration date 10 /2012 (received 12/21/09) 2. During an interview on 10/08/2019 at 2:10 pm, the laboratory manager stated they are a green laboratory now and don't use those reagents. She reviewed and confirmed the above findings. 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 --