American Skin And Cancer Center

Summary Statement of Deficiencies D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on survey review of the Procedure Manual (PM), Biannual Assessment Records (BAR) and interview with the Office Manager (OM) the laboratory failed to verify the accuracy of Histopathology testing from 8/24/21 to the date of survey. The findings include; 1. The reviewing physician stated in the PM was not the reviewing physician on the BAR for calendar years 2022 and 2023. 2. There was no documented evidence the referring physician reviewed the results of the BAR upon completion for calendar years 2022 and 2023. 5) The OM confirmed on 1/24/24 at 11:30 am that the laboratory failed to verify the accuracy of Histopathology testing. 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: 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 the lack of Temperature Logs (TL), review of the Users Manual (UM) for the Olympus CX43 microscope and interview with the Office Manager (OM), the laboratory failed to monitor and document room temperature and humidity where the Professional component (PC) for Histopathology tests are performed from 8/4/21 to the date of the survey. The findings include: 1. The UM defined the operating environment ambient temperature as 5 to 40C (41 to 104 F). 2. The UM defined the operating environment maximum as 80%. 3. There was no record of temperature or humidity in the office where the PC was being performed. 4. The OM confirmed on 1 /24/24 at 11:35 am the laboratory failed to monitor and document room temperature and humidity. -- 2 of 2 --

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 Records (TR) and interview with the Office Manager (OM), the laboratory failed to document Room Temperature (RT) where Histopathology test reagents were stored and tests were performed from 1/5/19 to the date of the survey. The findings include: 1. There were no temperatures recorded. 2. The OM confirmed on 8/24/21 at 12:45 pm that the laboratory failed to accurately record RT. 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 lack of maintenance records and interview with the Office Manager (OM), the laboratory failed to perform and document annual maintenance on the microscope 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 -- used in laboratory testing from 1/5/19 to the date of the survey. The OM confirmed on 8/24/21 at 12:30 pm there was no documented evidence that annual maintenance was performed on the microscope from January 2019 to the date of the survey. -- 2 of 2 --

Summary Statement of Deficiencies D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on surveyor review of the Personnel Files (PF), the lack of Training Records (TR) and interview with the Office Manager (OM), the Laboratory Director failed to ensure appropriate training for one of one testing personnel was on file from May 2018 to the date of the survey. The OM confirmed on 1/15/19 at 12:30 pm that TR were not in the PF. 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 --