Kentucky Skin Cancer Center

Summary Statement of Deficiencies D0000 A Recertification Survey was conducted on 08/13/2024. The facility was found not to be in compliance with the laboratory requirements of 42 CFR Part 493 with deficiencies cited. 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 facility policy reviews, facility document reviews, and confirmed in staff interview; the facility failed to assess and document the quality control performance of a Hematoxylin and Eosin (H&E) histochemical stain used in the evaluation of Mohs micrographic surgical slides at the start of each day of patient testing. Specifically, the facility failed to document daily H&E slide stain quality control assessments for 88 of 192 days of Mohs patient testing reviewed. Findings included: An undated facility policy titled, "Quality Assurance for Routine Stains," revealed, "1. A quality control slide will be run each day the lab operates." The policy revealed, "The lab director will determine whether the stain is acceptable for the day. Each QC [quality control] will be logged on the stain QC chart. Any corrections needed for that day will be addressed at that particular time and all changes will be documented." An undated facility policy titled, "Stain Maintenance," revealed, "8. The first case of mohs day will be documented as the quality control and logged on the QC sheet. 9. Any deficiencies or corrections will be documented and corrected." An undated facility policy titled, "Stain Maintenance Auto-Stainer," revealed, "10. A QC 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 -- worksheet is documented daily on the stain quality and any corrections or changes made." An undated document titled, "Hematoxylin and Eosin Stain," revealed, "Quality Assurance: The first case submitted to the mohs lab which consists of NORMAL tissue will be stained for H&E and documented on the control sheet as the QA [quality assurance]." A comparative review of completed Mohs patient logs versus daily Mohs slide H&E quality control logs, found in the binders labeled "Mohs Records 2023" and "Mohs Records 2024" for the timeframe from 01/01/2023 through 08/13/2024, when compared to a standard calendar for 2023 and 2024, revealed the following statistics: - Total number of days of Mohs patient testing: 192 - Number of daily H&E slide stain quality control assessments not found: 88 - Total number of Mohs patient testing cases: 832 - Number of Mohs patient testing cases with no H&E slide stain quality control assessments documented: 396 During an interview on 08/13 /2024 at 8:45 AM, the Laboratory Director confirmed that the H&E slide quality control results had not been documented on a daily basis and that Mohs patient testing had been performed despite that fact. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted on 12/28/2022 and the facility was found not to be in substantial compliance with the laboratory requirements at 42 CFR Part 493, with deficiencies cited. 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, record review, and review of the facility's policies, the facility failed to ensure the proficiency and accuracy of histopathology specimens were verified at least twice annually. The findings include: Review of the facility's policy titled, "Proficiency Testing", undated, revealed "Semi-annually, the tech [technician] or Risk Manager will send two (2) cases containing the original slides, label it with only the surgical case number, and send it out for a microscopic examination by a Board Certified Dermatologist. No differential diagnosis will be offered with the specimen. The slide may be labeled 'Proficiency Test' by the sending laboratory for the records of the reference laboratory." The policy further indicated, "Results of each Proficiency Test will be entered in a log and kept in the laboratory management manual, as part of its permanent records." A review of the facility's proficiency test records revealed only one (1) peer review evaluation was performed for 2022. Interview with Testing Personnel #1, on 12/28/2022 at 11:53 AM, revealed only one (1) proficiency test peer evaluation was performed in 2022. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially 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 -- available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on observation and interview, the facility failed to perform maintenance of the microscope used to perform examination of specimens from 10/2019 through 12 /2022. The findings include: Observation during the laboratory tour, on 12/28/2022 at 11:40 AM, revealed the Laboratory Director (LD) was reading a slide on the microscope. The last preventative maintenance was noted to have been performed 10 /2019. Interview with the LD, on 12/28/2022 at 12:30 PM, revealed there had been no preventative maintenance performed on the microscope between 10/2019 and 12 /2022. -- 2 of 2 --