Nikko Dermatology

Summary Statement of Deficiencies D0000 An announced survey of the laboratory was conducted on 05/30/2025. The laboratory was found in compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories) for the specialties/subspecialties for which it was surveyed. STANDARD LEVEL DEFICIENCIES were 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 review of laboratory's policies/procedures, twice annual test accuracy verification studies, annual test volumes and staff interview, the laboratory failed to document twice annual test accuracy verification for two of two events in 2024. Findings included: 1. Review of laboratory's policy "Proficiency Testing Mohs Micrographic Surgery Skin Specimens" (approved by Laboratory Director in 2021) revealed: "Semi-annually, the tech or Risk Manager will send two 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(sic) Dermatopathologist." 2. Review of laboratory's twice annual test accuracy verification studies revealed the last verification study was documented in November 2023. There was no documentation of the semi-annual verification of test accuracy in 2024. 3. Review of laboratory's submitted annual test volume revealed the laboratory performed two MOHS procedures in 2024. 4. In an interview on 05/30/2025 at 0950 hours in the laboratory, the facility's Medical Assistant (as indicated on submitted Survey Entrance/Exit Conference document) confirmed the findings. 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 D0000 An announced survey of the laboratory was conducted on 09/08/2023. The laboratory was found out of compliance with the CLIA regulations (42 CFR Part 493, Requirements for Laboratories). The CONDITIONS NOT MET were: D5028 - 42 C. F.R. 493.1219 Condition: Histopathology D6076 - 42 C.F.R. 493.1441 Condition: Laboratories performing high complexity testing; laboratory director D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of laboratory's random patient test records and staff interview, the laboratory failed to retain patient's Mohs maps for 2 of 25 patient test records reviewed. Note: This is a repeat deficiency from the survey conducted on 09/21/2021. Findings included: 1. Review of laboratory's random patient test records for 2022 and 2023 revealed the following 2 of 25 reviewed case numbers did not have Mohs maps available for review: Case number: M20-115 Mohs Performed: 01/11/2023 Case number: M20-119 Mohs Performed: 01/12/2023 2. In an interview on 09/08/2023 at 1730 hours in the laboratory, the facility's Medical Assistant (as identified on submitted Survey Entrance/Exit Conference document), stated that the Mohs maps were scanned into the system, but could not find them. No paper copies were available for review. This confirmed the findings. D5028 HISTOPATHOLOGY CFR(s): 493.1219 If the laboratory provides services in the subspecialty of Histopathology, 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 10 -- laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1273, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of laboratory's proficiency test (PT) records, policies/procedures, quality control (QC) records, maintenance records, patient test records, surveyor's observations and staff interview the laboratory failed to meet the requirements for the specialty of histopathology as evidenced by: 1. The laboratory failed to document evaluation of PT results. Refer to D5221. 2. The laboratory failed to follow its own policy/procedure for reagent maintenance. Refer to D5401. 3. The laboratory failed to ensure no expired reagents were used. Refer to D5417. 4. The laboratory failed to ensure cryostat maintenance was performed. Refer to D5429. 5. The laboratory failed to document Hematoxylin and Eosin stain quality control. Refer to D5473. 6. The laboratory failed to document

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies, a random review of patient's test records, and staff interview, it was revealed the laboratory failed to retain the Mohs maps for four of seven patients reviewed between February 2020 and August 2021. Findings include: 1. A review of the laboratory's policy titled 'Test Procedures' revealed the following: "Documentation required for each test performed: - Laboratory Test Log - Test Requisition - Mohs Map - Pathology Report - Operative Report Completing and retaining all documentation is not only required by CLIA, but is also necessary for insurance audits." 2. A random review of patient test records from February 2020 to August 2021 revealed the following four patient's records did not include the Mohs map: Case number: M20-012 Procedure date: 2/26/20 Case number: M20-015 Procedure date: 4/15/20 Case number: M20-018 Procedure date: 5 /22/20 Case number: M20-030 Procedure date: 10/23/20 3. An interview with testing person #3 (as indicated on the CMS 209 form) on 9/21/21 at 9:50 a.m. in the nurse's station, after review of the records, confirmed the above findings. 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 -- 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 a review of the laboratory's accuracy assessment records from 2020 and staff interview, it was revealed the laboratory failed to have documentation of performing two of two twice annual accuracy assessments for Mohs slide interpretations in 2020. Findings include: 1. A review of the laboratory's accuracy assessment records revealed the laboratory failed to have documentation of verifying the accuracy of the Mohs slides at least twice annually in 2020. 2. An interview with testing person #3 (as indicated on the CMS 209 form) on 9/21/21 at 9:00 a.m. in the nurse's station, after review of the records, confirmed the above findings. -- 2 of 2 --