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Summary Statement of Deficiencies D5821 TEST REPORT CFR(s): 493.1291(k) (k)When errors in the reported patient test results are detected, the laboratory must do the following: (k)(1) Promptly notify the authorized person ordering the test and, if applicable, the individual using the test results of reporting errors. (k)(2) Issue corrected reports promptly to the authorized person ordering the test and, if applicable, the individual using the test results. (k)(3) Maintain duplicates of the original report, as well as the corrected report. This STANDARD is not met as evidenced by: Based on surveyor review of quality assurance / quality control (QA/QC) records, procedures, and patient reports and interview with the regional manager (Staff A), the laboratory did not maintain duplicates of the original report as well as the corrected report for one of one corrected report reviewed. Findings include: 1. Review of the 'Mohs QA/QC' log from 2024 showed staff audit three patient procedures for five criteria each quarter. The five criteria evaluate consistent reporting between the patient slides, Mohs map, procedure visit notes, and Mohs log, and completion of the required components on the Mohs map and retention of slides. The form showed the possible responses for each criterion as "P = Pass, F = Fail". The form referenced Policy M-733, 'Quality Assessment Program Mohs Lab'. The second record in the fourth quarter (Patient 1) showed staff marked the second criteria, "Mohs map matches procedure visit note", with "F addendum added". 2. Review of Policy M-733 showed the policy required review of patient and laboratory records to ensure the laboratory has accurate medical records. 3. Review of the patient procedure visit notes for Patient 1 in the electronic medical record (EMR) showed no addendum made to the report. Review of the electronic copy of the 'Mohs Micrographic Surgery Map' for Patient 1 showed the source "left leg B". It looked as if staff had written the word 'left' over white-out and the handwriting for the word 'left' was different compared to 'leg B'. 4. Interview with Staff A on May 28, 2025, at 10:45 AM confirmed the patient 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 visit notes did not include an addendum and confirmed the map appeared altered. Staff A also confirmed staff did not retain an original copy of the map. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) (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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on surveyor review of quality assurance policies and interview with the Regional Manager (Staff A) the laboratory had not established written policies and procedures for correcting problems identified during result audits. Findings include: 1. Review of laboratory quality assurance policies showed no evidence the laboratory had a policy providing direction to staff for correcting errors identified during quarterly result audits. 2. Interview with Staff A on May 28, 2025, at 10:45 AM confirmed the laboratory procedures did not include instructions for making corrections to patient records including the requirement to retain duplicates of the original report as well as the corrected report. -- 2 of 2 --

Summary Statement of Deficiencies D3013 FACILITIES CFR(s): 493.1101(e) Records and, as applicable, slides, blocks, and tissues must be maintained and stored under conditions that ensure proper preservation. This STANDARD is not met as evidenced by: Based on surveyor observation of retained slides in the laboratory and interview with the regional manager, the laboratory did not maintain slides in a manner that ensured their preservation; staff could not separate multiple stored slides from three of six Mohs cases performed in 2022 and 2023. Findings include: 1. Observation on May 24, 2023 at approximately 2:00 PM of retained slides from six Mohs cases performed in 2022 and 2023 showed slides from the following three cases were stuck together and could not be separated to view individually: Patient 1: The patient had two Mohs cases on July 12, 2022, one set of two slides and a second set of six slides could not be separated for review. Patient 2: The patient had a Mohs case on December 30, 2022, two slides from the first stage could not be separated, and two slides from the second stage and a slide from the following Mohs case could not be separated for review. 2. Interview with the regional manager (staff A) on May 24, 2023 at approximately 2:00 PM confirmed the laboratory did not store the slides in a manner that ensured proper preservation to allow review of individual slides. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. 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 -- This CONDITION is not met as evidenced by: Based on surveyor review of laboratory records and interview with the regional manager, the laboratory director did not ensure the established quality assessment program was sufficient to identify and correct failures in quality as they occurred in charting patient results for two of six Mohs cases and one of two frozen section cases reviewed. See D6094. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and interview with the regional manager, the laboratory director did not ensure the established quality assessment program was sufficient to identify and correct failures in quality as they occurred in charting patient results for two of six Mohs cases and one of two frozen section cases reviewed. Findings include: 1. Review of laboratory quality assurance records from 2022 monitoring the accuracy of entry between the patient log, 'Mohs Micrographic Surgery Maps', medical records, and slides showed the laboratory evaluated three patient records each quarter in 2022. Results from the third and fourth quarters showed the reviewer determined five of the elements evaluated were not acceptable. No record of review of additional records or

Summary Statement of Deficiencies 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 surveyor review of maintenance logs and interview with the regional manager, staff A, the laboratory had not documented required maintenance for the cryostat instrument for fifty-five of ninety days from January through August in 2021. Findings include: 1. Review of the "Cryostat Maintenance and Temperature Log" stated "A check mark in the Maintenance column indicates that maintenance (per cryostat procedure) is done daily when Mohs is performed". 2. Review of the "Cryostat Maintenance and Temperature Log" for 2021 showed the laboratory did not record daily maintenance on the Leica cryostat for: January: five of seven days. February: four of eight days. March: two of nine days. April: zero of eight days. May: zero of eight days. June: one of seven days. July: twenty-one of twenty-one days. August: twenty-two of twenty-two days. 3. Interview with staff A on October 26, 2021 at 1:40 PM confirmed the laboratory had not documented required maintenance for the cryostat instrument for fifty-five of ninety days from January through August in 2021. 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 --