Center For Dermatology & Skin Surgery, Llc

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 surveyor review of the Procedure Manual and interview with the Office Manager (OM), the laboratory failed to establish a detailed procedure for Biannual Assessment (BA) from on the date of survey. The findings include: 1. The BA procedure did not include the name of the referring pathologist. 2. The BA procedure requires the Mohs map to be sent to the reviewing pathologist. 3. The BA does not list a third party to review in the instance when the referring physician results do not match the reviewing physicians results. 4. The OM confirmed on 3/16/25 at 1:15 pm that the BA procedure was not in detail. 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 D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on surveyor review of the Temperature Log (TL) and interview with the Office Manager (OM), the laboratory failed to define an acceptable temperature range for the Leica Cryostat used in Histopathology tests from 2/3/19 to the date of the survey. The OM confirmed on 9/23/21 at 10:00 am that an acceptable range was not defined. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. 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 STANDARD is not met as evidenced by: Based on surveyor review of the Final Report (FR), Mohs Maps (MM), Accession Log (AL) and interview with the Office Manager(OM), the laboratory failed to ensure that test results are accurately transcribed from the AL to the final destination from 2/3 /19 the date of the survey. The finding includes: 1. One out of ten AL did not correspond with the Mohs map and stage number on the FR. 2. The OM confirmed on 9/23/21 at 10:30 am the laboratory did not ensure that all results were entered accurately. -- 2 of 2 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on surveyor review of the Competency Assessment (CA) records and interview with the Office Manager (OM), the laboratory failed to perform CA correctly on two of two Testing Personnel in the calendar years 2017 and 2018. The findings include: 1. The CA did not include how assessment was performed. 2. The CA did not include assessment of problem solving skills. 3. The OM confirmed on 2/13/19 at 10:15 am that CA was not done correctly. D5781