Us Dermatology Partners

Summary Statement of Deficiencies D0000 The US Dermatology Partners laboratory in Waco 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 09/29 /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 a review of the laboratory's policy and procedure, reagent logs, interview, and pre-survey paperwork, the laboratory failed to retain the lot numbers, open dates, and expiration dates for the chemicals and stains used in the laboratory for its Hematoxylin and Eosin stain used in Mohs testing for 10 out of 15 months reviewed from 02/01/2025 - 06/30/2026. Findings follow. A. Review of the laboratory policy and procedure titled Quality Assessment Manual, revised 01/08/2019, under Reagent Expiration Date stated, "Reagents, solutions, calibration materials, and other supplies are not used when they have exceeded their expiration dates, have deteriorated or are of substandard quality." B. Review of the reagent log from 02/01/2025 - 06/30/2026 showed missing lot numbers, open and expiration dates of the following chemicals and stains over a period of 10 months: Entry date chemical/stain Lot# Missing dates 1. 02/21/2025 100% alcohol not documented expiration date 2. 04/18/2025 95% alcohol 2500704 expiration date 3. 04/25/2025 100% alcohol not documented expiration date 4. 05/09/2025 95% alcohol not documented expiration date 5. 06/13/2025 Eosin not documented expiration date 6. 06/13/2025 100% alcohol not documented expiration date 7. 07/11/2025 95% alcohol not documented expiration date 8. 07/11/2025 100% 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 -- alcohol not documented expiration date 9. 08/18/2025 Eosin not documented expiration date 10. 08/18/2025 95% alcohol not documented 11. 10/17/2025 95% alcohol not documented expiration date 12. 12/08/2025 Eosin not documented expiration date 13. 02/16/2026 95% alcohol not documented expiration date 14. 02/16 /2026 Bluing not documented open date & expiration date 15. 02/23/2026 95% alcohol not documented expiration date 16. 05/01/2026 Eosin 45060284 open date 17. 05/15/2026 95% alcohol not documented expiration date 18. 05/19/2026 100% alcohol not documented expiration date C. Interview with the histotech on September 29, 2026 at 1410 hours in the breakroom confirmed the findings and acknowledged they were taking the information off the packing slips instead of the bottle and some information was not provided on the packing slips. D. Review of the CMS Form 116 showed the estimated annual testing volume was 1,938 blocks. 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 policy and procedure titled Quality Assessment Manual, revised 01/08/2019, was not signed by the Laboratory Director. B. Interview with the Practice Administrator on September 29, 2026 at 1430 hours in the breakroom confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies 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 peer reviews and interview, the laboratory failed to assess accuracy of its Mohs testing for 2 of 4 events reviewed from 2020 and 2021. Findings follow. A. Review of the Twice Annual Quality Assurance from 2020 and 2021 showed the accuracy assessments were performed on 07/15/2020 and 08/10/2021. The reports also showed the peer reviews were performed for "Final diagnosis" versus clear margins, accurate maps and slides, and slide quality. B. Interview with the histotech on August 31, 2022, at 1005 hours in the breakroom acknowledged she started in July 2021 and confirmed two accuracy assessments were performed in 2020 and 2021, and that the diagnosis comes off the biopsy and agreed Mohs checks for clear margins on the final stage and should have accurate maps and slides. Interview with the Clinic Manager on August 31, 2022, at 1010 hours in the breakroom acknowledged when the last histotech left, they did not know everything that needed to be done and confirmed there was no procedure for accuracy assessments. 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: 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 -- Based on observation, manufacturer's instructions and interview, the laboratory failed to ensure expired reagents and stains were not available for use in the laboratory. Findings follow. A. During a tour of the laboratory on August 31, 2022, at 0940 hours, the following four reagents and stains were found in the chemical cabinet: 1. Stat Lab Gill 3 Hematoxylin, Lot 074804, expiration 07/01/2020, 1 gallon container, open; 2. Stat Lab Eosin-Y Alcoholic 0.25%, Lot 090140, expiration 11/30/2021, 1 gallon container, open; 3. Stat Lab Eosin-Y Alcoholic 0.25%, Lot 070181, expiration 10/01/2020, 1 gallon container, unopened; 4. Stat Lab 95% Reagent Alcohol, Lot 081766, expiration 05/01/2021, 1 gallon container, unopened. B. Interview with the histotech on August 31, 2022, at 0940 hours in the laboratory confirmed the reagents and stains were expired. Further interview on August 31, 2022, at 1000 hours in the breakroom when asked to see the reagent log acknowledged she did not realize they were supposed to keep a reagent log and just started one in July 2022. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of patient reports and interview, the laboratory failed to include the correct test name for two out of three Scabies test reports reviewed. Findings follow. A. Review of three test reports for Scabies showed two were found under KOH (potassium hydroxide) Prep (used to identify fungal elements) versus Scabies Prep. 1. MRN: 55388888505, DOS 03/07/2022; 2. MRN: 5385863, DOS 07/27/2021. B. Interview with the Clinic Manager on August 31, 2022, at 1100 hours in the breakroom acknowledged she didn't know they were different and documents according to what the provider wanted, and thought they were essentially the same thing. -- 2 of 2 --

Summary Statement of Deficiencies 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 the laboratory's quality assurance records from 2018 through 2020 and staff interview, it was revealed the laboratory failed to have documentation of performing twice annual accuracy assessment for KOH preparations in 2018 and 2019. Findings included: 1. A review of the laboratory's Parasitology and KOH Competency Exams from 2018 through 2020 found documentation of verification of the accuracy of results for KOH preparations done once each year in 2018 and 2019. The laboratory was not enrolled in a CMS approved proficiency testing program for Clinical Microscopy. 2. An interview with the clinic manager conducted on November 5, 2020 at 10:45 a.m. confirmed the laboratory was neither enrolled in a proficiency testing program nor did the laboratory verify the accuracy of the test results for KOH at least twice a year in 2018 or 2019. Key: KOH - Postassiu hydroxide CMS - Centers for Medicare and Medicaid Services 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 --