Us Dermatology Partners

Summary Statement of Deficiencies D0000 The US Dermatology Partners in Cedar Park laboratory was found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, CLIA requirements for laboratories as a result of a recertification survey on 05/15/2026 and recertification is recommended. Standard level deficiencies were cited. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. In addition, retain the following: This STANDARD is not met as evidenced by: Based on review of the manufacturer's instructions, reagent log, quality control (QC) log, and interview the laboratory failed to retain the stain name, manufacturer, lot number, expiration date, received date, and open date of the Immunohistochemical (IHC) stains used in the laboratory for the SOX-10, MART-1, and Cytokeratin AE1 /AE3 (PanCK) stains used in Mohs testing for 2 of 2 years reviewed. Findings follow. A. Manufacturer's Instructions: 1. Review of the Instructions for Use for SOX-10, Rev B DCN: 3976, under Stability stated, "This product is stable up to the expiration date on the product label. Do not use after expiration date listed on the package label." 2. Review of the Instructions for Use for MART-1, Rev B DCN:3975, under Stability stated, "This product is stable up to the expiration date on the product label. Do not use after expiration date listed on the package label." 3. Review of the Instructions for Use for Cytokeratin AE1/AE3 (PanCK), Rev B DCN: 3978, under Stability stated, "This product is stable up to the expiration date on the product label. Do not use after expiration date listed on the package label." B. Review of the reagent log from May Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- 2024 - April 2026 was missing the documentation of the stains SOX-10, MART-1, and PanCK. C. Review of the IHC Stain Control Log from 07/10/2024 - 05/14/2026 showed at least 126 cases were reported for SOX-10, 44 cases for MART-1, and 11 cases for PanCK. D. Interview with the histotechnician on May 15, 2026 at 1510 hours confirmed the findings. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) (d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the laboratory policies and procedures and interview, the laboratory director failed to sign and date one of one laboratory policies and procedures prior to use. Findings follow. A. Review of the laboratory's policies and procedures showed the following procedures titled Procedure Manual Mohs Micrographic Surgery, revised 01/27/2022, was not signed by the Laboratory Director. B. Interview with the histotechnician on May 15, 2026 at 1600 hours confirmed the findings. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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 review of the laboratory's policies and procedures, reagent log, patient testing logs, and interview, the laboratory failed to ensure chemicals and stains used in the Hematoxylin and Eosin (H&E) stain used to process Mohs specimens had not exceeded their expiration date for 34 out of 365 days reviewed for Gill 3 Hematoxylin. Findings follow. A. Review of the laboratory's policies and procedures titled Procedure Manual Mohs Micrographic Surgery, revised 01/27/2022, under C. Test Methods, Equipment, Reagents, Material, and Supplies at 5.f stated, "If reagents, solutions, controls, calibration materials, KOH stains, or other laboratory supplies have exceeded their expiration dates, have deteriorated, or are of substandard quality they are to be disposed of according to the policies and procedures of USDP laboratory." B. Review of the reagent log showed Gill 3 Hematoxylin, Lot #194712, expiration 09/30/2025 was opened on 05/05/2025, and the next entry for Gill 3 Hematoxylin, Lot #220335, expiration date 08/31/2026 received 04/07/2025 and opened on 11/03/2025 revealed an elapsed expiration of 34 days. C. Review of the Mohs Patient Log Book from 10/02/2025 - 11/02/2025 showed 17 days of Mohs testing with expired Gill 3 Hematoxylin with 103 cases reported: case# 861-964. D. Interview with the histotechnician on May 15, 2026 at 1500 hours confirmed the findings. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) -- 2 of 3 -- (b)(9) Evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's competency evaluations, pre-survey paperwork, and interview, the technical consultant failed to evaluate the competency at least semiannually during the first year the individual tested patient specimens for one of two new employees for Potassium Hydroxide (KOH) for fungal elements. Findings follow. A. Review of the CLIA Competency Assessment Form stated, "Competency assessment, which includes the following six procedures, must be performed for testing personnel for each test that the individual is approved by the laboratory director to perform. This must be performed twice in the first year, then on an annual basis." There was no policy and procedure that addressed competency evaluations outside this form. B. Review of the pre-survey paperwork titled Laboratory Personnel showed testing personnel #7 (as listed on the CMS form 209) was hired 11/04/2024. C. A semi-annual competency evaluation for testing personnel #7 was performed 12 /05/2025. A second semi-annual competency evaluation was requested on May 15, 2026 at 1405 hours but not provided. D. Interview with the histotechnician on May 15, 2026 at 1405 hours confirmed the findings. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. 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 Mohs accuracy peer reviews and interview, the laboratory failed to access accuracy of its Mohs testing of clear margins on the final stage and accurate maps for 2 of 2 years reviewed. Findings follow. A. Review of the Twice Annual Quality Assurance performed on 12/08/2021, 05/18/2021, 12/04/2020, and 06/16 /2020 showed the peer reviews were performed for "Final diagnosis". B. Interview with the histotech on May 20, 2022 at 1100 confirmed the diagnosis comes off the biopsy and agreed Mohs checks for clear margins on the final stage and should have accurate maps. 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. 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 manufacturer's instructions, quality control records, patient charts, and interview, the laboratory failed to document the reactions of the immunohistochemical (IHC) stain control slides for two of two years reviewed. Findings follow. A. Review of the Novodiax ihcDirect SOX10 Ab-Enh Instructions for Use, IFU-00036-EN-A July 2020, under Quality Control Procedures stated, "Positive and negative controls should be run simultaneously with patient specimens. Positive Tissue Control: The recommended positive control tissues for this antibody are properly processed melanoma and skin. The staining is nuclear for melanoma cells and melanocytes in skin. One positive tissue control for each set of test conditions should be included in each staining run. Previous tissue specimens that have been frozen and freshly cut or in some cases, an individual's own tissue may be used as controls... Negative Tissue Control: The same tissue used for the positive control may be used as the negative tissue control." B. Review of the laboratory's quality control records from 2022- 2020 showed no documentation of the ICH stains. C. Review of 11 patient test reports, slides, and maps showed 4 included the ihc stain SOX10. Review of the patient charts for the 2022 cases: 0277, 0273, 0254, 0186 did not mention the performance of the controls. D. Interview with the histotech on May 20, 2022 at 1340 confirmed the quality control for SOX10 was not noted in the patient's chart. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on review of the testing logs, patient charts, and interview, the laboratory failed to ensure testing for KOH and Scabies was recorded on the appropriate testing logs for two of two months reviewed for four of four patients. Findings follow. A. Review of the Scabies Logs showed results for 4 patients (3 negative, 1 positive) from 09/01 /2021 - 10/12/2021. B. Review of the corresponding patient charts showed all were reported as a KOH: three negatives for hyphae, and one positive for spores. No mention of Scabies test performed. MRN 1076754, 09/01/2021, postitive: spores; MRN 5380045, 09/28/2021, negative: no hyphae; MRN 5203648, 10/08/2021, negative: no hyphae; MRN 2674649, 10/12/2021, negative: no hyphae. C. Interview with the Lead Medical Assistant on May 20, 2022 at 1415 acknowledged the medical assistants logged the testing for the physician, and the Scabies Log must have been used to document the KOH testing. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in substantial compliance with the conditions of the CLIA regulations found at CFR 42 493.1 through 493.1780 and recertification is recommended. D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on surveyor observations, review of facility procedures and records, and interview with facility staff, the laboratory failed to ensure the emergency eye wash saline was not expired for 6 of 6 months reviewed. The findings included: 1. At 13:54 hours on 12/11/2020, the surveyor observed the emergency eye wash saline, lot number 13049-21, had expired on 01/2016. 2. Based on review of laboratory policy last approved by the laboratory director on 12/03/2020, the policy titled "Quality Control Policies and Documentation" stated "The following equipment must be monitored" and included "Eye Wash: Must be tested each day for proper working order." 3. Based on review of the form titled "2020 Eye Wash Log", the eye wash station was checked 8 times in June 2020, 11 times in July 2020, 17 times in August 2020, 17 times in September 2020, 15 times in October 2020, 14 times in November 2020, and 7 times between December 1, 2020 and the say of the inspection, December 11, 2020, for a total of 89 documented checks in 6 of 6 months reviewed. 4. In an interview on 12/11/2020 at 14:00 hours in the laboratory, the histotech stated she was unaware the emergency eyewash saline had an expiration date. 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 --