Center For Dermatology Laser & Cosmetic Surgery

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 review of laboratory records, lack of documentation, and interview with the Anatomic Pathology Consultant (APC), the laboratory failed to monitor and document room temperature and humidity to ensure operating conditions were met for 1 of 1 Nikon E-200 Microscope used to perform histopathology slide examinations from 04 /12/2023 to the date of survey. Findings include: 1. The operating environment listed in the instruction manual for the Nikon E-200 microscope states: "room temperature 0C-40C, relative humidity 85% Max." 2. On the date of the survey, 03/05/2025 at 9: 54 am, the laboratory failed to provide documentation for monitoring room temperatures and humidity to ensure operating conditions were met for the 1 of 1 Nikon E-200 microscope (s/n 10050212) used to perform histopathology slide examinations from 04/12/2023 to 03/05/2025. 3. The laboratory performed 7557 histopathology slide examinations from 04/12/2023 to 03/05/2025. 4. The APC confirmed the findings above on 03/05/2025 at 10:50 am. 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 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 the lack of quality assurance (QA) documentation and interview with the laboratory's anatomic pathology consultant, the laboratory director (LD) failed to ensure a QA program was established and maintained to ensure the quality of services provided by the laboratory from 02/25/2021 to the date of the survey. Findings include: 1. On the date of the survey, 04/12/2023 at 10:30 am, the laboratory could not provide documentation for the periodic QA evaluation performed to assess the laboratory's pre-analytical, analytical, and post-analytical processes from 02/25/2021 to 04/12/2023. 2. The laboratory performed 2,678 histopathology examinations in 2022 (CMS-116 annual volume). 3. The laboratory's anatomic pathology consultant confirmed the findings above on 04/12/2023 around 12:00 pm. 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 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 review of the competency assessment procedure, review of personnel competency assessment records and interview with the laboratory consultant, the laboratory failed to establish a complete competency assessment procedure to assess 1 of 1 pathologist performing Dermatopathology slide examinations in 2019, 2020 and 2021. Findings Include: 1. On the day of survey, 02/24/2021, the laboratory could not provide a complete competency assessment procedure to assess the competency for 1 of 1 pathologist performing Dermatopathology slide examinations in 2019, 2020 and 2021. 2. Review of competency assessment records for 1 of 1 pathologist performing Dermatopathology slide examinations revealed, they were not assessed for the following areas of competency in 2019, 2020 and 2021: - Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. - Direct observation of performance of instrument maintenance and function checks. - The assessment of problem solving skills. 2. The laboratory consultant confirmed the finding above on 02/24/2021 around 9:30 am. 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. 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 observation of the Olympus BX 41 microscope and interview with laboratory consultant, the laboratory failed to perform maintenance/calibration on 1 of 1 Olympus BX 41 microscope from 08/17/20219 to 02/03/2021. Findings include: 1. On the day of survey, 02/24/2021, observation of the microscope revealed, 1 of 1 Olympus BX 41 microscope was due for maintenance /calibration on 08/17/2019. 2. The Olympus BX 41 microscope was recently calibrated on 02/03/2021. 3. The laboratory consultant confirmed the finding above on 02/24/2021 around 10:10 am. D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on surveyor review of Hematoxylin and eosin (H&E), special and immunohistochemical (IHC) stain quality control (QC) records and interview with the laboratory consultant, the laboratory failed to document QC for Periodic acid-Schiff (PAS) special stains examined in 2019 and 2020. Findings include: 1. The Technical Lab Information on histology stain: H&E, Special stains and Immuno stain QC procedure states, "Upon completion and microscopic evaluation of the controls slide (s) on the H&E stain, special stain or immuno stain the technologist who evaluates the slides(s) must fill out the slide and stain log from each stain and immuno done. The H&E slide used for the control for each day is also noted at the top of the slide and stain log form." 2. On the day of survey, 02/24/2021, review of a sampling of H&E, Special stains and IHC stain QC logs revealed, QC was not performed for the following PSA special stains examined in 2019 and 2020: 2019: -Case#: HFL2020- 1259. -Case#: HFL2020-1260. -Case#: HFL2020-1250. -Case#: HFL2020-1218. - Case#: HFL2020-1210. -Case#: HFL2020-1244. 2020: -Case#: HFL2019-002185. - Case#: HFL2019-002189. -Case#: HFL2019-002144. -Case#: HFL2019-002142. - Case#: HFL2019-002143. -Case#: HFL2019-002214. -Case#: HFL2019-002221. - Case#: HFL2019-002266. -Case#: HFL2019-001913. 2. The laboratory examined 39 special stain slides in 2019. 2. The laboratory examined 47 special stain slides in 2020. 3. The laboratory consultant confirmed the findings above on 02/24/2021 around 9:45 am. -- 2 of 2 --