Tru-Skin Dermatology

Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and recertification is recommended. Standard level deficiency was cited. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for high 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 policy and procedure, pre-survey paperwork, competency evaluations, and interview, the technical supervisor failed to evaluate the competency at least semiannually during the first year the individual tested patient specimens for one of one testing personnel performing Mohs testing. Findings follow. A. Review of the laboratory's policy and procedure titled Competency Assessment Protocol, approved 06/28/2021, stated, "The histotechnician will add reminder dates for the completion of the assessment to be done annually. The manager will monitor to ensure this is done annually." The policy and procedure did not address new employees twice per year competency evaluations in the first year. B. Review of the pre-survey paperwork titled Laboratory Personnel showed testing personnel #1 (as listed on the CMS form 209) was hired 03/2023. C. One additional semi-annual competency evaluation for testing personnel #1 was requested on February 6, 2025 at 0955 hours but not provided. D. Interview with the Regional Director of Operations on February 6, 2025 at 0955 hours confirmed only one competency evaluation was performed in the first year of testing. 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 representatives 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. D1000 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(c) Certificate of waiver tests. A laboratory may qualify for a certificate of waiver under section 353 of the PHS Act if it restricts the tests that it performs to one or more of the following tests or examinations (or additional tests added to this list as provided under paragraph (d) of this section) and no others: (1) Dipstick or Tablet Reagent Urinalysis (non-automated) for the following: (i) Bilirubin; (ii) Glucose; (iii) Hemoglobin; (iv) Ketone; (v) Leukocytes; (vi) Nitrite; (vii) pH; (viii) Protein; (ix) Specific gravity; and (x) Urobilinogen. (2) Fecal occult blood; (3) Ovulation tests-visual color comparison tests for human luteinizing hormone; (4) Urine pregnancy tests - visual color comparison tests; (5) Erythrocyte sedimentation rate-non-automated; (6) Hemoglobin- copper sulfate-non-automated; (7) Blood glucose by glucose monitoring devices cleared by the FDA specifically for home use; (8) Spun microhematocrit; and (9) Hemoglobin by single analyte instruments with self-contained or component features to perform specimen/reagent interaction, providing direct measurement and readout. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions, observation, interview, query, and pre- survey paperwork, the laboratory failed to ensure the Osom hCG Urine Control Set used for Pregnancy tests had not been used after its expiration date. Findings follow. A. Review of the Osom hCG Urine Control Set package insert, 3076-3 06/15, under Warnings and Precautions stated, "DO NOT use the Controls beyond the expiration date." B. During a tour of the laboratory on November 9, 2022, at 1115 hours in the laboratory, the surveyor observed the Osom hCG Urine Control Set, Lot 201211, 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 -- expiration 10/31/2021 in the laboratory refrigerator. No other controls were in the laboratory. C. Interview with the medical assistant on November 9, 2022, at 1115 hours said she "just ran out and threw away the old box". D. Query of McKesson orders as far back as 03/2021 showed no urine controls had been ordered. E. Interview with the Practice Director on November 9, 2022, at 1130 hours in the breakroom agreed it didn't look like any other controls existed since it would be unlikely for controls to have been reordered prior to 03/2021 when the known set of controls didn't expire until 10/21. F. Review of pre-survey paperwork showed approximately 150 pregnancy tests were performed annually. KEY: hCG = human Chorionic Gonadotropin D3043 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(7) The laboratory must retain cytology slide preparations for at least 5 years from the date of examination (see 493.1274(f) for proficiency testing exception). The laboratory must retain histopathology slides for at least 10 years from the date of examination. The laboratory must retain pathology specimen blocks for at least 2 years from the date of examination. The laboratory must preserve remnants of tissue for pathology examination until a diagnosis is made on the specimen. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, slide review, and interview, the laboratory failed to retain slides from its Mohs cases for at least 10 years for 52 out of 55 cases from Nov 2012 - Feb 2013. Findings follow. A. Review of the laboratory's policy and procedure titled Storage of Diagnosed Slides, approved on 09/26/2022, stated, "In this facility, diagnosed slides will be stored in the following manner: ...4. Slides are kept for a total of ten years." B. Review of slide retention showed slides from case number M12-150 to M12-180 from November 19, 2012, to December 17. 2012 and case number M13-001 to M13-022 from January 9, 2013, to February 28, 2013, were unavailable for review. C. Interview with the histotech on November 9, 2022, at 1100 in the breakroom confirmed she had slides from cases M13-023 and higher. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, Mohs patient reports and interview, the laboratory failed to include the Mohs case number on the Mohs report for four out of 10 cases reviewed from September 2022 to December 2020. Findings follow. A. Review of the laboratory's policies and procedures showed no procedure for ensuring the Mohs case was on the patient chart. B. Review of the laboratory's Mohs patient reports showed the Mohs case number was missing for cases 1. M21- -- 2 of 3 -- 073, 2. M21-009, 3. M20-070, 4. M20-066. C. Interview with the Clinic Manager on November 9, 2022, at 1155 in the breakroom acknowledged it was the same Medical Assistant who did not include the Mohs case number in the report. -- 3 of 3 --

Summary Statement of Deficiencies D5219 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(2) At least twice annually, the laboratory must verify the accuracy of any test or procedure listed in subpart I of this part for which compatible proficiency testing samples are not offered by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of the laboratory policies and procedures, quality assurance records, and staff interview, it was revealed the laboratory failed to have documentation of performing twice annual accuracy assessment for MOHS surgical procedures in 2020. Findings included: 1. Review of the laboratory's own policy titled ANNUAL PEER TO PEER REVIEW PROTOCOL (tru-skin) dated 04/04/2017 found: " annually, the tech or Lab Director will select a total off two mohs cases from one of the following clinics: Bastrop, LaGrange, Kerrville or Austin. They will choose one stage 1 case and one stage 2 case for submission within the current year. A completed case submission form, slides and a copy of the original mohs map will be submitted to Dr. [name omitted] or Dr. [name omitted] for final review. Once the Mohs surgeon has reviewed and signed off on the two cases, copies of both reports will be placed in each clinics PEER TO PEER REVIEW binder and recorded in the PEER TO PEER REVIEW calendar." 2. Review of peer review records found one case for the assessment of accuracy of results for the Mohs testing performed in 2020. Additional peer reviews were requested but not provided. 3. Interview of the practice manager conducted on May 27, 2021 at 09:47 AM confirmed there were no other peer reviews for Mohs procedures conducted in 2020 available for review. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an 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 -- ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Review of policies and procedures and interview of facility personnel found the laboratory failed to follow their own quality assessment procedure to monitor, assess and correct problems identified in the analytic systems in 2020. The findings included: 1. Review of policies and procedures found in the policy titled Quality assessment( signed 03/05/2018) " Annually the tech will check off the quality assessment program for procedures used in the office. The checklist is used to evaluate general laboratory systems, preanalytic systems, analytic systems and post anlytic systems." Checklists for 2020 were requested but not provided. 2. Interview of the histotechnician conducted on May 27, 2021 at 09:32 AM confirmed that the laboratory did not complete the quality assurance activities in 2020. -- 2 of 2 --

Summary Statement of Deficiencies 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 surveyor observations and interview with facility personnel, the laboratory failed to ensure 3 of 5 tissue marking dyes were not used beyond their expiration and 1 of 1 hematoxylin tissue stains was not used beyond its expiration. The findings included: 1. At 13:31 hours on 2/8/2019 in the laboratory, the surveyor observed the following three (3) of five (5) tissue stains on the tool cart next to a cryostat: Cancer Diagnostics, Inc. Tissue Marking Dye, Applicator Series Color: Orange Lot: 15240 Expiration: 2017/03 Elapsed time: expired for 1 year, 10 months, 8 days Cancer Diagnostics, Inc. Tissue Marking Dye, Applicator Series Color: Red Lot: 16047 Expiration: 2017/08 Elapsed time: expired for 1 year, 5 months, 8 days Cancer Diagnostics, Inc. Tissue Marking Dye, Applicator Series Color: Green Lot: 16042 Expiration: 2017/08 Elapsed time: expired for 1 year, 5 months, 8 days 2. At 13:37 hours on 2/8/2019 in the laboratory, the surveyor observed the following expired hematoxylin stain in the laboratory's flammable cabinet: Avantik Gill 3 - Hematoxylin Lot: 045097 Expiration date: 09/17 Elapsed time: expired for 1 year, 4 months, 8 days 3. In an interview at 13:37 hours on 2/8/2019 in the laboratory, the medical assistant /histotechnican confirmed the expired tissue marking stains and hematoxylin stain had been used in patient testing. None of the containers contained an open date. Based on the CMS-116 submitted on the day of the survey, the laboratory performed 250 tests in histopathology annually. 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 --