University Of Maryland Dermatologists

Summary Statement of Deficiencies D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: I. Based on review of the standard operating procedure (SOP) and interview with the histology technician (HT), the laboratory failed to define a function check protocol for the hood used for during the staining of slides. Findings: 1. The "Laboratory Maintenance" section of the SOP failed to include a schedule for the maintenance of the hood used in the slide staining area. 2. During the survey on 07/11/24 at 12:00 PM, the HT confirmed that the SOP failed to include instructions for scheduling maintenance of the hood used in the staining area. II. Based on review of the SOP and interview with the HT, the laboratory failed to perform and document microscope maintenance. Findings: 1. The "Laboratory Maintenance" section of the SOP states that the microscope will have biannual maintenance performed. At the time of the survey there were no microscope maintenance records available. 2. On 07/16/2024 at 2:29 AM via email, the HT confirmed that the biannual microscope maintenance records were not available. The laboratory failed to maintain documentation of the microscope use for interpretation of Mohs slides. 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 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 with the testing person (TP), the laboratory failed to have an eyewash station in the area where Mohs surgery patient slides were processed. Findings: 1. It was observed that the area where patient slides from Mohs surgery were prepared and stained did not contain an eyewash station to aid in flushing out the eyes of testing personnel should they be splashed with staining reagents. 2. During the survey on March 2, 2023 at 1:00 PM, the LD confirmed that an eyewash station was not located in the area where patient slides were processed. 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 the procedure and laboratory records and interview with the testing person (TP), the laboratory failed to document the biannual accuracy /proficiency verification of the Mohs surgeon in 2021 and 2022. Findings: 1. The procedure titled "Diagnostic Proficiency Review" stated that "Each Mohs surgeon, including the Mohs laboratory director, will submit cases on a bi-annual basis for review to verify accuracy/proficiency of the diagnosis and testing procedure. The Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- cases will be reviewed for stain quality, diagnosis, and completeness of tissue margins. This will be documented on the Mohs case review log. " 2. The procedure went on to state that if "the review must take place off-site" then the "accession number, number of slides, and patient MRN will be logged on the slide tracking log that is created for all slides not in the laboratory." 3. Review of laboratory records showed that there were no Mohs case review logs and no slide tracking log documenting biannual accuracy/proficiency verification. 4. In an email received on 03 /16/2023 at 12:42 PM, the TP confirmed that biannual accuracy/proficiency verification was not documented for the Mohs surgeon in 2021 and 2022. 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)

Summary Statement of Deficiencies 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)

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 interview with the laboratory (lab) director, the lab did not have written procedures to At least twice annually, verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. Findings: 1. The lab did not have a written procedure for at least twice annually splitting histology cases with another surgeon to compare technique and microscopic observations; 2. The lab did not have a written procedure to document these split reviews between surgeons; 3. The lab did not have written procedure to recognize discrepant results and