Oak Dermatology

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 laboratory policies and procedures, laboratory records, lack of documentation, and interview with the laboratory representative; the laboratory failed to perform biannual method accuracy (proficiency testing/peer reviewed Mohs micrographic carcinoma exclusion results) for four of four Mohs events performed in 2024 and 2025 in the subspecialty of histopathology. Findings include: 1. Review of laboratory policies and procedures revealed the policy titled "Proficiency Testing Policy", which stated, under "3. Mohs Proficiency Testing (Slide Review)", "Results ....If it appears there is a positive margin that was not[e] detected, the patient will be called ...." 2. Review of biannual method accuracy documentation for Mohs micrographic cases revealed the diagnostic interpretation of the carcinoma was peer- reviewed by an outside reviewer, not the accuracy of the Mohs micrographic carcinoma exclusion procedure. Year/Event: Mohs Case #: Diagnosis: 2024/1st Event 1-ABM-24-0003 SCC* 2024/1st Event 1-ABM-24-0012 SCC 2024/1st Event 1-ABM- 24-0023 BCC** 2024/1st Event 1-ABM-24-0028 BCC 2024/1st Event 1-ABM-24- 0033 BCC 2024/2nd Event 1-ABM-24-0032 BCC 2024/2nd Event 1-ABM-24-0043 BCC 2024/2nd Event 1-ABM-24-0070 BCC 2024/2nd Event 1-ABM-24-0083 SCC 2024/2nd Event 1-ABM-24-0093 BCC 2025/1st Event 1-ABM-25-0006 SCC 2025 /1st Event 1-ABM-25-0016 BCC 2025/1st Event 1-ABM-25-0037 SCC 2025/1st Event 1-ABM-25-0045 BCC 2025/1st Event 1-ABM-25-0059 BCC 2025/2nd Event 1- ABM-25-0075 SCC 2025/2nd Event 1-KBM-25-0001 SCC 2025/2nd Event 1-KBM- 25-0014 SCC 2025/2nd Event 1-KBM-25-0040 SCC 2025/2nd Event 1-KBM-25- 0078 BCC *SCC = Squamous Cell Carcinoma **BCC = Basal Cell Carcinoma 3. Interview with the laboratory representative on 01/28/2026, at 10:27 am, confirmed 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 -- the laboratory failed to perform biannual method accuracy (proficiency testing/peer reviewed Mohs micrographic carcinoma exclusion results) for four of four Mohs events performed in 2024 and 2025 in the subspecialty of histopathology. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of the CMS-209 (Laboratory Personnel Report) Form, laboratory policies and procedures, laboratory records, lack of documentation, and interview with testing personnel (TP) #8; the technical supervisor (TS) failed to evaluate the competency of five of five TP performing microscopic scabies wet mount testing in the subspecialty of parasitology in the years of 2024 and 2025. Findings include: 1. Review of the CMS-209 (Laboratory Personnel Report) Form revealed five TP performing microscopic scabies wet mount testing (TP #2, TP #3, TP #5, TP #6, and TP #7). 2. Review of laboratory policies and procedures revealed the policy titled "Competency Assessment Policy", which stated, under "2. Scabies Competency Assessment", "Documentation ...Results of the evaluation will be documented on the Scabies Competency Assessment form by the performing provider." 3. Review of laboratory competency records revealed a lack of documented scabies competency assessment for all five TP performing microscopic scabies wet mount testing in 2024 and 2025. 4. Interview with TP #8 on 01/28/2026, at 10:29 am, confirmed the TS failed to evaluate the competency of five of five TP performing microscopic scabies wet mount testing in the subspecialty of parasitology in the years of 2024 and 2025. -- 2 of 2 --

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedures manual; CLIA survey forms; accession logs; and patient test records, and interviews with the histology technician and laboratory director, the laboratory failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and correct problems identified in the general laboratory system requirements as specified. Findings: 1. Review of the laboratory's Quality assessment policy (bullet #2) states, "All Quality Control (QC) records (such as log sheets, logs of test requisitions, test report and Receipt/QA or regents and culture media) will be reviewed by the Laboratory Director or an appropriate, designated staff member. All forms will be signed and dated on the date of review." 2. The laboratory's procedures manual revealed that the laboratory director assigned himself as Laboratory Director, Clinical Consultant, Technical Supervisor, General Supervisor, and Testing Personnel of Histopathology testing. 3. Review of CLIA survey FORM CMS 209 (Laboratory Personnel Report) show that the laboratory director was listed as Clinical Consultant, Technical Supervisor, General Supervisor, and Testing Personnel for High Complexity Histopathology testing. 4. On survey date 09/18/19 at 11:30 AM, the surveyor selected 6 patients from the Mohs Accession log. The Mohs Accession Log included the following information: a. Mohs# b. Patients' Last and First Names c. Specimen Site d. Type of Cancer e. Stage 5. The surveyor requested the following information for the 6 patients selected: a. Mohs Map b. Quality Control (QC)Records c. Patients' slides d. QC slides 6. Mohs maps were used as the official surgery report where the following 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 -- information was documented: a. Date of Service (DOS) b. Patient's Last and First names c. Mohs# d. Specimen site d. Tissue Orientation 7. One of 6 patient's specimen sites documented on the Mohs Surgery Report / Map did not match information that was recorded on the Mohs Accession Log. The site documented on the Mohs Surgery Report / Map was recorded as R Mid Paraspinal, while "Left Mid Paraspinal" was recorded on the Mohs Accession Log. The same Mohs # was recorded for both. 8. There was no documentation to show any

Summary Statement of Deficiencies 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: Based on review, procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. Finding: 1. Review of the

Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation and interview; safety procedures were not established and observed to ensure protection from physical, chemical, biochemical and electrical hazards, and biohazardous materials. Findings: 1. On 05/10/18, during the walk- through of the laboratory, the surveyor observed that there was a microtome; a cabinet with staining solutions and patients' stained slides; 2 massage chairs; a desktop fountain; and a refrigerator with bottled drinking water. The Mohs technician explained that the 2 massage chairs; desktop fountain; and refrigerator belonged to the dermatology office that they shared space with. The surveyor noted that the other dermatology office had its own CLIA Certificate. However, there was no separation of the 2 spaces. 2. During survey date 05/10/18, the Mohs Technician confirmed the surveyor's findings. 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: 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 -- Based on review and interview; the laboratory failed to establish and follow written policies and procedures that ensured positive identification and optimum integrity of the patients' specimens form the time of collection of the specimen through completion of testing and reporting of results. Findings: 1. Review of the laboratory's procedures manual revealed that patients' specimens are submitted with a Mohs map that includes the following information: a. Patient's first and last name b. Medical Record # c. Date of Birth e. Tissue Site f. Case Number (a different Case number for each Tissue Site) e. Date g. Diagnosis h. Referring Physician 2. Review of patient testing log revealed that the following information is documented: a. Patient's first and last name b. Medical Record # c. Date of Birth d. Tissue Site e. Case Number f. Number of Stages g. Date 3. Reviews of 4 patient's slides revealed that there was no tissue site recorded on the labels of 4 of 4 patients' slides. 4. During survey date 05/10 /18, the Mohs technician confirmed the surveyor's findings. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)