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Summary Statement of Deficiencies 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 surveyor observation of slides in the laboratory, review of procedures, and interview and email with the regional manager (Staff A), the laboratory did not follow written policies and procedures to ensure positive identification of seven of fifty- seven patient histology slides for patients one through thirteen. Findings include: 1. Observation of three slide folders in the laboratory on March 19, 2026, at 10:05 AM revealed the folders contained stained histology slides from patients one through thirteen and one quality control (QC) slide. Of the fifty-seven slides in the folders, seven did not include identifying information. The seven unlabeled slides showed stained tissue sections preserved with coverslips attached. 1a. Tray 1 contained the following: Slide number on tray | labeled for patient number 1 - 4 | Patient 1 5 - 7 | Patient 3 8 | unlabeled slide 9 | no slide 10 | Patient 6 11-13 | Patient 2 14 - 16 | Patient 5 17 | unlabeled slide 18 | QC 19-20 | Patient 6 1b. Tray 2 contained: 1-3 | Patient 4 4 | unlabeled slide 5 - 13 | Patient 4 14 - 16 | Patient 8 17 | unlabeled slide 18 - 19 | no slide 20 | unlabeled slide 1c. Tray 3 contained: 1 - 3 | Patient 9 4 | unlabeled slide 5 - 7 | Patient 11 8 - 10 | Patient 12 11 - 13 | Patient 10 14 - 16 | Patient 7 17 - 19 | Patient 13 20 | unlabeled slide 2. Review of the laboratory's "Slide Labeling" procedure showed the instructions included: "1. Upon starting a new case ALL slides to be used for that case will be labeled with a permanent marker. 2. Slides are to be labeled with mohs log accession number, patient last name...". The procedure continued with instructions for labeling of the stages, quadrants or number of chucks, and each individual slide. 3. Interview with Staff A on March 19, 2026, at 10:20 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 slides were not labeled. 4. Email with Staff A received March 23, 2026, at 11:02 AM confirmed the unlabeled slides were patient slides and confirmed the procedures to ensure positive patient identification of tissue samples were not followed. -- 2 of 2 --

Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on surveyor review of the frozen section log and reports, observation of slides, and interview with the Regional Clinic Manager, the laboratory did not follow their procedures for documenting and assigning a unique identification number to two of four frozen section slides reviewed. Findings include: 1. Review of the frozen section log for specimens processed in 2023 showed personnel assigned FS23-0002 through FS23-0004 to Patient 1 on October 30, 2023. 2. Observation of slides on January 23, 2024, at 10:50 AM revealed four slides labeled FS23-0002 through FS23-0004; two slides labeled FS23-0002 and one slide each labeled FS23-0003 and FS23-0004. The label of one of the FS23-0002 slides included the name of Patient 1, the second FS23- 0002 slide included the name of Patient 2. 3. Review of patient reports showed a frozen section report for Patient 1 on October 30, 2023. The report identified the tissue from location C as FS23-0002. A report for Patient 2 on October 9, 2023, identified the tissue from location A as FS23-0002. 4. Interview with the Regional Clinic Manager (staff A) on January 23, 2024, at 10:55 AM confirmed FS23-0002 for Patient 2 was not assigned in the frozen section log as required by procedure and confirmed the same accession number was used for two different patient tissue samples. D5805 TEST REPORT 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 -- 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 surveyor review of patient reports and interview with the Regional Clinic Manager, two of three frozen section reports for Patient 1 did not include the microscopic description test results. Findings include: 1. Review of the test report for Patient 1 from October 30, 2023, showed the physician obtained three biopsies (location A, B, and C) by shave method and processed the tissue using frozen section methodology. The report showed: Location / Accession number / result included: A / FS23-0003 / report included microscopic description B / FS23-0004 / no microscopic description C / FS23-0002 / no microscopic description 2. Interview with the Regional Clinic Manager (staff A) on January 23, 2024, at 10:45 AM confirmed the physician did not include the frozen section microscopic description on two of three samples from Patient 1 on the patient report. -- 2 of 2 --