Longhorn Dermatology

Summary Statement of Deficiencies D0000 The Longhorn Dermatology 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 December 4, 20205 and recertification is recommended. Standard level deficiencies were cited. 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 observation, manufacturer's instructions, pre-survey paperwork, and interview, the laboratory failed to ensure reagents were not used beyond their expiration for four of seven tissue marking dyes currently in use by the laboratory used in Mohs testing. Findings follow. A. Surveyor observed on December 4, 2025 at 1500 hours in the laboratory four of seven Cancer Diagnostic Tissue Marking Dyes available and in use by the laboratory were expired as listed by color, lot number, and expiration date: Color Lot # Expiration date 1. Orange 23082 03/31/2025 2. Red 23122 05/31/2025 3. Purple 23180 06/30/2025 4. Yellow 23258 09/30/2025 B. Interview with the histotech on December 4, 2025 at 1505 hours in the laboratory confirmed the findings. C. Review of the CMS form 116 showed approximately 2011 blocks were performed 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 --

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. 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. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies and procedures, laboratory's records, pre-survey paperwork, and interview, the laboratory failed to retain the chemical name and concentration (if applicable), manufacturer, lot number, expiration date, received date, and open date of the chemicals and stains used in the laboratory for the Hematoxylin and Eosin (H&E) stain used in Mohs processing for one of one years reviewed. Findings follow. A. Review of the laboratory's policy and procedure titled Mohs Quality Control Program, Origination date 09/2021, stated under Quality Control of Reagents: "1. Correct labeling of reagents and chemicals should include content and concentration, date received or prepared, date opened, expiration date, and storage temperature. 2. Commercially obtained reagents will be labeled to indicate date received, date opened. The manufacturer's expiration date will be utilized. If no expiration date is on the container, an expiration date of one year from the received date is assigned as the expiration date. 3. Expired reagents are not to be used and are discarded." B. The reagent log was requested on February 2, 2024 at 1055 hours but not provided. Review of the Daily H&E Quality Control Check Log from January to December 2023 showed documentation of the Lot number and Expiration date for Gill's 3 Hematoxylin and Eosin-y with Phloxine stains. Lot number and expiration date were requested for the Alcohol, xylene, and bluing on 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 -- February 2, 2024 at 1200 hours but not provided. C. Review of the CMS Form 116 showed approximately 1000 Mohs stages were performed annually. D. Interview with the technologist on February 2, 2024 at 1200 hours confirmed the findings. 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 policies and procedures, accuracy assessments, pre-survey paperwork, and interview, the laboratory failed to perform twice a year accuracy assessments of Mohs for one of two years reviewed. Findings follow. A. Review of the laboratory's policy and procedure titled Mohs Quality Control Program, Origination date 09/2021, stated under Quality Management (QM) for Mohs Surgery: "TWO cases per calendar year by an ASMS or ACMS fellow of Mohs Micrographic Surgery or board-certified Dermatopathologist from an outside laboratory and TWO interdepartmental cases per calendar year PER Mohs surgeon by an ASMS or ACMS fellow of Mohs Micrographic Surgery or a board-certified Dermatopathologist. Two cases (frozen section slides and Mohs map) are selected randomly from the current year by the technician and submitted to an external Mohs surgeon or dermatopathologist and in house MD for outside and inter department quality assurance respectively. The dermatologist reviewing the case will judge whether the sections and staining are adequate and whether the margins are free of tumor. This will be kept on file in the laboratory." B. Review of the accuracy assessments from 2022 and 2023 showed no accuracy assessments performed in 2023. Additional accuracy assessments were requested on February 2, 2024 at 1040 hours but not provided. C. Review of the CMS Form 116 showed approximately 1000 Mohs stages were performed annually. D. Interview with the technologist on February 2, 2024 at 1040 hours confirmed the findings. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of the manufacturer's instructions, laboratory's policies and procedures, preventative maintenance (PM) records, pre-survey paperwork, and interview, the laboratory failed to perform periodic preventative maintenance on the Accu-Scope 3000-LED Microscope used for Mohs testing for two of two years reviewed. Findings follow. A. Review of the Accu-Scope 3000-LED Microscope Series Manual obtained on-line, under Service stated, "Accu-Scope Microscopes are precision instruments which require periodic servicing to keep them performing properly and to compensate for normal wear." B. Review of the laboratory's policy and procedure titled Mohs Quality Control Program, Origination date 09/2021, showed preventative maintenance and microscope were not mentioned. C. Preventative maintenance records were reviewed from 06/05/2021 - 02/02/2024 and -- 2 of 3 -- showed no preventative maintenance records for the microscope available for review. Preventative maintenance records for the microscope were requested on February 2, 2024 at 1130 but not provided. D. Review of the CMS Form 116 showed approximately 1000 Mohs stages were performed annually. E. Interview with the technologist on February 2, 2024 at 1130 hours confirmed there was no PM performed on the microscope. D6127 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 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 two of two semi-annual competency evaluations in Mohs testing. Findings follow. A. Review of the laboratory's policy and procedure titled Mohs Quality Control Program, Origination date 09/2021, showed no mention of competency evaluations. B. Review of the pre-survey paperwork titled Laboratory Personnel showed testing personnel #1 (as listed on the CMS form 209) was hired in January 2023. C. Two semi-annual competency evaluations for testing personnel #1 were requested on February 2, 2024 at 1030 hours but not provided. D. Interview with the technologist on February 2, 2024 at 1030 hours confirmed competency evaluations were not performed. -- 3 of 3 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of policies and procedures and interview of facility personnel it was revealed that the laboratory failed to have a written procedure to assess the competency of supervisors, consultants and testing personnel performing high complexity testing in histopathology. Findings included: 1. There was no written procedure available for review for assessing the competency of testing personnel. 3. Interview of testing person one listed on the CMS report 209 Laboratory Personnel Report conducted May 3, 2022 at 09:49 AM confirmed the laboratory did not have a written procedure for assessing the competency of supervisors, consultants or testing personnel. D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: Based on a review of the Laboratory Personnel Report, personnel records and staff 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 -- interview, it was revealed that one of three testing personnel performing high complexity testing (gross analysis of tissue specimens) did not have the appropriate education credentials required to perform high complexity testing (refer to D6171). D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) -- 2 of 3 -- (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: Review of the CMS Report 209 Laboratory Personnel report, personnel records and interview of facility personnel found the laboratory failed to ensure one of three testing personnel listed on the CMS report 209 met the minimum education requirements to perform High complexity testing in Histopathology. The findings included: 1. Review of the CMS report 209 Laboratory Personnel Report found the laboratory documented 3 individuals as testing personnel performing high complexity testing. 2. Review of personnel records found no education records available for review for testing person three. 3. Interview of testing person two conducted May 3, 2022 at 09:54 AM confirmed the laboratory did not have education records for testing person three and that she did perform gross analysis of tissue specimens. Interview of testing person three conducted May 3, 2022 at 09:58 AM confirmed she did not have at least an associate degree to qualify for high complexity testing in histopathology. -- 3 of 3 --