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 deficiencies were cited. 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 accuracy assessments and interview, the laboratory failed to verify the accuracy of its KOH (potassium hydroxide) for fungal elements at least twice annually for two of two years reviewed in 2022 and 2023. Findings follow. A. Accuracy assessments for KOH in 2022 and 2023 were requested on 11/20/2024 at 1140 hours but not provided. B. Interview with the Regional Director of Operations on November 20, 2024 at 1140 hours confirmed they did not perform twice per year accuracy assessments for KOH in 2022, 2023, nor to survey date in 2024. 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 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 -- competency at least semiannually during the first year the individual tested patient specimens for one of two semi-annual competency evaluations in Mohs testing. Findings follow. A. Review of the laboratory's policy and procedure titled Competency Assessment Protocol, effective 06/28/2021, stated, "Annual Competency Assessment must be performed by the lab director on individuals responsible for high complexity testing. 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 testing within 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 05/13/2023. C. Review of the semi-annual competency evaluations for testing personnel #1 revealed only one performed in the first year on 09/30/2023. D. Interview with the Regional Director of Operations on November 20, 2024 at 1125 hours confirmed one semi- annual competency evaluation was not performed. -- 2 of 2 --

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. D5407 PROCEDURE MANUAL CFR(s): 493.1251(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: I. Based on review of the laboratory's policies and procedures, interview, and pre- survey paperwork showed the laboratory failed to ensure the Mohs procedures were signed and dated by the laboratory director prior to use. Findings follow. A. Review of the Mohs Policies and Procedures showed the line for the Laboratory Directors' approval and date were blank. B. Interview with the Clinic Manager on September 14, 2022, at 1120 hours in the breakroom confirmed the findings. C. Review of the CMS form 116 showed an estimated annual test volume of 140 for Mohs. II. Based on review of the laboratory's policies and procedures, testing logs, and interview, the laboratory failed to ensure the KOH (potassium hydroxide) procedure for fungal elements was signed and dated by the laboratory director prior to use. A. Review of the KOH policy and procedure showed the procedure was not signed and dated by the Laboratory Director. B. Review of the patient testing logs showed KOH testing began on 03/30/2022 and 14 patients had been tested. C. Interview with the Clinic Manager on September 14, 2022, at 1040 hours in the breakroom confirmed the findings. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) 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 -- 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, interview, and test logs, the laboratory failed to ensure reagents had not exceeded their expiration date for KOH (potassium hydroxide) testing for fungal elements for 18 of 18 months. Findings follow. A. During a tour of the laboratory on September 14, 2022, at 1215 hours, the surveyor observed a bottle of Delasco Potassium Hydroxide 10% with DMSO next to the microscope in the provider office. B. The bottle of Delasco Potassium Hydroxide 10% with DMSO, Lot K18294, had an expiration date of 2021/02/28: 1yr, 6 months, and 18 days expired. C. Interview with the Clinic Manager on September 14, 2022, at 1215 hours in the provider office confirmed the findings. D. Review of patient testing logs from 03/30/2022 - 09/14/2022 showed 14 patients had been tested. D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, testing logs, and interview found that the laboratory director failed to ensure that all procedures available to testing personnel had been approved signed in dated by the current laboratory director. (See 5407 I & II). -- 2 of 2 --

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's policies and procedures, accuracy assessment records, and interview, the laboratory failed to perform twice annual accuracy assessments for Mohs histopathology in 2020 and 2019. Findings follow. 1. Review of the laboratory's policy titled ANNUAL PEER TO PEER REVIEW PROTOCOL (tru-skin) dated 04/04/2017 stated "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 2019. Additional peer reviews were requested but not provided. 3. Interview with the clinical manager on March 17, 2021 at 1030 hours in the breakroom confirmed there were no other peer reviews for Mohs procedures conducted in 2019 and 2020 available for review. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially 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 -- available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on review of the manufacturer's instructions, laboratory policies and procedures, annual service records, maintenance logs, observation, and interview, the laboratory failed to perform annual and monthly maintenance, and failed to document daily maintenance performed as defined by the manufacturer using the Avantik Cryostat used to cut frozen sections for Mohs testing. Findings follow. I. Annual Service 1. Review of the Avantik QS11 Instruction Manual, 387779, under 5-3 Cleaning and Care of the Microtome stated, "NOTE: For the examination and readjustment of the microtome a routine maintenance should be performed by trained service technician once a year." 2. Annual service reports were requested but not provided. 3. Interview with the clinical manager on March 17, 2021 at 1045 hours in the breakroom confirmed annual service had not been performed. II. Air filter 1. Review of the Avantik QS11 Instruction Manual, 387779, under 5-4 Cleaning the Cooling Lamella stated, "open the cleaning opening via the attached tool (fig 29.1)... Remove the dust from the cooling lamella by means of a commercially available vacuum cleaner. NOTE: Carry out this cleaning in regular intervals. Thus extending the lifetime of the compressor." 2. Review of the Equipment Quality Control - Cryostat Maintenance Record from Jan - Dec 2020 did not have a column for cleaning the cooling lamella on the form. 3. Surveyor observation on March 17, 2021 at 1050 hours in the laboratory the cooling lamella on the cryostat was visibly dirty. 4. Interview with the histotechnologist on March 17, 2021 at 1045 hours in the breakroom confirmed she does not perform that maintenance. III. Oil/grease 1. Review of the Avantik QS11 Instruction Manual, 387779, under 5-3 Cleaning and Care of the Microtome stated, "after each shutting-off or cleaning of the cryostat, the cross roller bearing should be lubricated. By means of a pipette (fig 27.3) the cross roller bearings (fig 27.4) can be reached from an angle from behind below the housing (fig 27.1). Fill the pipette with a small amount of cryostat oil. Put one or two drops into the space (fig 27.2) of the cross roller bearings. The specimen clamping should be in the lower position. Also slightly lubricate the horizontal cylinder guide behind the specimen clamping." 2. Review of the laboratory's policy and procedure titled Daily Routine and Laboratory Daily Maintenance did not include oiling/greasing the cryostat. 3. Review of the Equipment Quality Control - Cryostat Maintenance Record from Jan - Dec 2020 did not have a column for oiling or greasing the cryostat. 4. Interview with the histotechnologist on March 17, 2021 at 1055 hours in the breakroom confirmed she does not document when she oils or greases the cryostat. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on review of stain quality control records, and interview, the laboratory failed to verify the intended negative and positive reactivity for the Hematoxylin and Eosin (H&E) stain at least once each day of use. Findings follow. 1. Review of the laboratory's stain quality control record from 03/27/2020 - current, the laboratory initialed in the column for stain quality as documentation of H and E staining acceptability. 2. Additional documentation for H and E stain quality to ensure predictable staining was requested, but not provided. 3. Interview with the histotechnologist on March 17, 2021 at 1105 hours in the breakroom confirmed the physician was putting his initials instead of the stain quality of the control slide. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 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: Based on review of the laboratory's policy and procedure, quality assurance forms, and interview, the laboratory failed to follow their own policy for an ongoing mechanism to monitor, assess, and correct problems in the analytic systems. Findings follow. 1. Review of the laboratory's policy and procedure titled Quality Assurance stated, "Annually, the tech will check off the Quality Assurance Checklist. This will cover the quality assessment program for the procedures used in the office. The checklist is used to evaluate General Laboratory Systems, Pre-Analytic Systems, Analytic Systems, and Post-Analytic Systems. Any discrepancies found in the checklist during the annual check will be documented on a lab error form and kept in the manual..." 2. Review of the Annual Quality Assurance Checklist for 2019 and 2020 was requested but not provided. 3. Interview of the clinical manager on March 17, 2021 at 1130 hours in the breakroom confirmed Quality Assurance was not performed in 2019 and 2020. -- 3 of 3 --

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 records, policies and procedures quality assurance records from 2017 through 2018, patient test records for 2017 and 2018 and staff interview, it was revealed the laboratory failed to have documentation of performing twice annual accuracy assessment for KOH preparations in 2017 and 2018. Findings included: 1. Review of patient test records found that the laboratory tested 1 patient specimen for KOH between July 13, 2016 and September 17, 2018 2. Review of the policy / procedure titled KOH PEER TO PEER SLIDE PREP REVIEW - " Providers using KOH slide prep for diagnosis must log at least twice annually their slide prep date, patient and results in the KOH Slide Prep Journal found next to the microscope in the provider's office. The provider must then notify the next provider to be in office to read and confirm the slide results. The reviewing provider, date of review and review results should be recorded in the KOH Slide Prep Journal. Results should be communicated back to the originating providers. In the case of discrepancy, the Laboratory Director should be notified for separate review and confirmation. 3. A review of the laboratory's quality assurance checklists from 2017 (dated 02/22/2017) and 2018 (3/8/18) found on page 2 under KOH TESTER COMPETENCY PROFICIENCY will be assessed twice annually by laboratory director. This will be conducted by using blind samples. There was no documentation on the annual quality assurance checklist that this had been evaluated to ensure the quality assessment program identified and corrected problems. 4. An interview with the chief operation officer conducted on September 17, 2018 at 2:31 PM 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 each year in 2017 and 2018. 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 --