Legacy Dermatology Group

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 record review and interview with the Histology Technician (HT), the laboratory failed to ensure that initial and six-month competency assessments were performed for 1 (TP2) of 3 testing personnel reviewed. Findings include: 1. A review of the CMS-209 Form revealed that TP2 was listed as testing personnel performing high complexity testing. 2. A review of personnel competency assessment documentation revealed that TP2 began performing testing on October 20, 2025. Initial competency assessment and six-month competency assessment documentation were not available for review. 3. On 06/11/2026 at 12:15 p.m., the surveyor requested training and competency assessment documentation for TP2 and it was not provided. 4. A review of the laboratory's policy Legacy Dermatology Group, in the section titled "Training and Competency," paragraph #1, revealed that "All new laboratory personnel shall be trained on this SOP prior to performing independent slide labeling, with training documented in the personnel record." The policy further states in paragraph #2 that "Trained personnel shall sign a training attestation, that will also be signed by the laboratory director." 5. During an interview on 06/11/2026 at 12:15 pm, the HT confirmed initial training and competency assessment documentation had not been completed for TP2. 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 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 -- procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: . Based on record review and interview with the Histology Technician (HT), the laboratory failed to verify the accuracy of its testing at least twice annually for 1 (2025) of 2 years reviewed. Findings include: 1. A review of the laboratory's records revealed the laboratory did not have documentation to demonstrate twice annual verification of accuracy for January 2025 through December 2025. 2. A review of the laboratory's policy titled "Proficiency Testing" in paragraph #1 revealed "The laboratory director will ensure that results of Mohs slides are verified since no proficiency testing program is available for Mohs surgery." Additionally, in paragraph #2, it reveals that "...Slides from at least 2 Mohs cases are given to the dermatopathologist at 'referral lab' A for review twice a year." 3. An interview on 06 /11/2026 at 1:15 pm with the HT confirmed twice annual verification of accuracy was not performed for 2025. -- 2 of 2 --

Summary Statement of Deficiencies D3041 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(6) Test reports. Retain or be able to retrieve a copy of the original report (including final, preliminary, and corrected reports) at least 2 years after the date of reporting. (i) In addition, retain immunohematology reports as specified in 21 CFR 606.160(d) (ii) and pathology test reports for at least 10 years after the date of reporting. This STANDARD is not met as evidenced by: . Based on record review and interview with the office manager, the laboratory failed to retain its mohs histopathology test reports for at least 10 years for patients tested between November 2014 and April 2017. Findings include: 1. The surveyor requested a patient test report for a patient receiving mohs histopathology testing from 2016 on 11/18/24 at 11:02 am and it was not made available. 2. An interview on 11/18/24 at 11:33 am with the office manager revealed the laboratory started using their new electronic medical record in April 2017 and had not retained test reports prior to the change. 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 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 record review and interview with the Laboratory Director (LD) and the office manager (OM), the laboratory failed to establish a system to ensure the transcribed Mohs' surgical site was accurately transcribed from the Pathology Report (Path) onto the Mohs' map, Mohs' log, and in the patient's electronic medical record (EMR) visit note (Note) for 8 (B21-54, B21-63, B21-75, B21-103, B22-21, B22-37, B22-72, and B22-94) of 12 patient test records reviewed. Findings include: 1. A record review revealed for 8 of 12 Mohs' cases reviewed, the surgical site transcribed from the Path report onto the Mohs' map, Mohs' log, and in the Note in the EMR system was not transcribed accurately as follows: B21-54 i. Path - left anterior shoulder ii. Mohs' map, Mohs' log, and Note - left neck B21-63 i. Path, Mohs' map, and Mohs' log - right earlobe ii. Note - right anterior earlobe B21-75 i. Path, Mohs' map, and Mohs' log - left temple ii. Note - left inferior lateral forehead B21-103 i. Path and Note - left central malar cheek ii. Mohs' map and Mohs' log - left cheek B22- 21 i. Path, Mohs' map, and Mohs' log - nasal root ii. Note - left nasal root B22- 37 i. Path, Mohs' map, and Mohs' log - right forehead ii. Note - right lateral forehead B22- 72 i. Path, Mohs' map, and Mohs' log - midline dist bridge nose ii. Note - nasal dorsum B22-94 i. Path - left central postauricular skin ii. Mohs' map and Mohs' log - 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 -- left central postauricular iii. Note - left postauricular 2. An interview on 11/07/2022 at 11:00 am, the LD and OM confirmed the surgical site locations were not transcribed accurately. -- 2 of 2 --

Summary Statement of Deficiencies 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 record review and interview with the Laboratory Director (LD), the laboratory failed to include the address of the laboratory location where testing was performed on the Mohs' map for 2 (June 2019 to June 2021) of 2 years reviewed. Findings include: 1. A record review of patient Mohs' maps revealed a lack of the laboratory's address recorded on the Mohs' map for 2 (June 2019 to June 2021) of 2 years testing. 2. An interview on 6/14/2021 at 10:45 am, the LD confirmed the address of the testing laboratory was not included on the Mohs' map. 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 --