Anne Arundel Dermatology

Summary Statement of Deficiencies D3029 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(2) Test procedures. Retain a copy of each test procedure for at least 2 years after a procedure has been discontinued. Each test procedure must include the dates of initial use and discontinuance. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the laboratory consultant (LC), the laboratory failed to retain a copy of the procedure manual for Mohs surgery that was in use during 2025. Findings: 1. Since the previous recertification survey on 06/20/2024, the laboratory changed testing personnel (TP). 2. The TP were no longer employed by the laboratory as of 12/31/2025. 3. On 05/01/2026 at 9:45 AM, the LC confirmed that the new TP implemented a new procedure manual and that updated procedure manual was no longer available in the laboratory after the TP left on 12/31 /2025. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. In addition, retain the following: This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the laboratory consultant (LC), the laboratory failed to retain analytic systems records for Mohs surgery for the end of 2024 and 2025. Findings: 1. The laboratory used a logbook to log every Mohs 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 -- surgery patient and assign an accession number that was used for patient slides and test records. The last patient documented on the laboratory log was from 11/22/2024. 2. Everyday of patient testing a quality control (QC) slide was stained to determine the acceptability of the staining reagents. Stain quality was documented on a "Control Slide Log." The last QC result documented on the "Control Slide Log" was from 11/22 /2024. 3. The laboratory documented when staining reagents were changed or filtered in a reagent log. The last documented change of staining reagents was from 08/01 /2024. 4. The laboratory documented daily maintenance activities including cryostat and microscope maintenance, cleaning activities, and temperatures on a monthly "Lab Maintenance" form. The form had a section at the bottom for the laboratory director's signature and date of review. The last completed "Lab Maintenance" form was from 09/2024. Forms for 06/2024-09/2024 were not signed as reviewed by the laboratory director. 5. Since the previous recertification survey on 06/20/2024, the laboratory changed testing personnel (TP). The TP were no longer employed by the laboratory as of 12/31/2025. 6. On 05/01/2026 at 9:45 AM, the LC confirmed that the new TP implemented a new testing procedure manual (cross-refer to D3029). 7. A "Slide Temperature Log 2025" stated "Humidity/Room Temperature" and was in use for 2025. The log recorded room temperature only and did not include acceptable room temperature ranges. 8. During the exit interview on 05/01/2026 at 11:00 AM, the TC confirmed that all analytic systems records in use with the new TP were no longer available in the laboratory after the TP left on 12/31/2025. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) (a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the laboratory consultant (LC), the laboratory failed to retain proficiency testing (PT) records for Mohs surgery from 2024 and 2025. Findings: 1. The most recent documentation of PT was from 11 /20/2023. 2. The PT consisted of a slide review from a second Mohs surgeon to evaluate staining quality and surgical margins. 3. During the exit interview on 05/01 /2026 at 11:00 AM, the TC confirmed that there were no records for PT performed in 2024 or 2025. D3039 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(5) (a)(5) Quality system assessment records. Retain all laboratory quality system assessment records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the laboratory consultant (LC), the laboratory failed to retain quality system assessment records for Mohs surgery since the previous recertification survey on 06/20/2024. Findings: 1. Since the previous recertification survey on 06/20/2024, the laboratory changed testing personnel (TP) who implemented a new procedure manual that was no longer available in the laboratory after the TP left on 12/31/2025 (cross-refer to D3029). 2. Analytic systems records were not available for the end of 2024 and 2025 and had not -- 2 of 3 -- been signed as reviewed by the laboratory director (cross-refer to D3031). 3. The last documented proficiency testing record was from 11/20/2023 (cross-refer to D3037). 4. During the exit interview on 05/01/2026 at 11:00 AM, the TC confirmed that there were no records for quality system assessment since the previous recertification survey on 06/20/2024. -- 3 of 3 --

Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on review of the CLIA and Maryland State licensing database and interview with the histo technician (HT) and supervisor, the laboratory failed to complete the application process for updating the identity of the current laboratory director (LD) as required in the Code of Maryland Regulations COMAR10.10.07.01 Permitted POL [Physician Office Laboratory] and POCL [Point-of-Care Laboratory]- Director and Associate Director. B. Standards. (6) Changes in Employment or Service. A director shall notify the OHCQ [Office of Health Care Quality] within 30 days of any change in the director's service or employment as a laboratory director. Findings: 1. During the survey at 11:45 AM, the HT confirmed that the LD listed on the CLIA certificate and Maryland State licensing database left in August 2023. 2. During the survey on 06 /20/2024 at 12:45 PM, the HT and supervisor confirmed that the laboratory had not submitted an application to OHCQ update the identity of the qualified LD for the CLIA and Maryland State license. The laboratory failed to be in compliance with the applicable Maryland State laboratory requirements. 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: 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 -- Based on review of the policy and procedure manuals and interview with the histo technician (HT), the laboratory failed to have all the policies and procedures approved by the current laboratory director (LD). Findings: 1. Review of the policy and procedure manuals showed that they were signed by the LD listed on the CLIA certificate. When interviewed the HT stated that the LD had left in August 2023. The acting LD is listed on the "Laboratory Personnel Report CLIA" but the appropriate documents have not been submitted to the Office of Health Care Quality to make the changes. Refer to Tag D3009 for details. 2. During the survey on 06/20/2024 at 11:30 AM, the HT confirmed that the policy and procedure manuals were not signed by the current laboratory director. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on review of the Mohs maps and interview with the histo technician (HT), the laboratory's record system failed to identify the HT who performed the staining and slide preparation of each stage of the procedure. Findings: 1. According to the HT that was interviewed on 06/20/24 at 10:45 AM, whenever there are two HT's working the same day they both initial the "Histo" section of the Mohs map in case they perform staining of one of the stages. Moh's map #24-106 was pulled for review. The procedure was performed on 04/04/24 and there were two initials documented on the "Histo" section and two stages were performed before the margins were clear. The records failed to identify which HT performed the stage one or stage two staining. 2. During the survey on 06/20/2024 at 11:15 AM, the HT confirmed that the Mohs maps failed to identify which HT performed the staining and slide preparation for each stage of the testing. -- 2 of 2 --

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 review of maintenance records and interview with the testing person, the laboratory did not maintain maintenance records for all instruments utilize for performing patient testing and for the overall acceptability of laboratory testing. Findings: 1. The laboratory did not have a record of the autoclave spore checks performed during the year 2017 up to the time of survey. 2. The testing person stated that spore checks were performed on the autoclave but documentation of the check was not available. 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 --