Advanced Dermatology Center

Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on the surveyor's observation during the laboratory tour and interview with office manager (OM), it was determined that the laboratory failed to have an established, accessible, and observed safety procedures to ensure protection from any physical, chemical, biochemical, electrical hazards, and biohazardous materials. The findings include: 1. Based on the laboratory tour on January 31, 2025, at approximately 12:40 p.m., the surveyor observed: a. No eye wash station or portable bottles was found within the testing area where biohazardous materials were processed. b. One out of three fire extinguishers in the facility was missed during the last annual service. Two were last serviced on July 14, 2024, while the one at the laboratory was last serviced on June 30, 2023. 2. The OM affirmed by interview on January 31, 2025, at approximately 12:40 p.m. that the laboratory lacked an eye wash and that the fire extinguisher was missed from the last annual service as mentioned in statement #1. 3. Based on the laboratory's annual testing volume declaration submitted at the time of the survey, the laboratory processed and reported approximately 100 patient test samples for Dermatopathology. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) (b)(2)(i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(2)(ii) Perform and document the function checks, including 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 -- background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on a review of the laboratory's preventive maintenance (PM) documentation, five (5) randomly selected patient test records, and an interview with the office manager (OM), it was determined that the laboratory failed to ensure performed tests and function checks were documented properly prior to patient testing. The findings include: 1. Based on the review of the 5 patient test records, no

Summary Statement of Deficiencies 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 the lack of the laboratory's Mohs reports peer review, review of five (5) randomly chosen histopathology patient's reports, and interviews with the laboratory's office manager (OM) on April 5, 2023; it was determined that the laboratory failed to verify, at least twice annually, the accuracy of its histopathology tests for the years 2021 and 2022. The findings included: 1. The laboratory did not have any documentation showing that it had verified its histopathology Mohs tests' accuracy for the years 2021 and 2022 for the dermatopathologist performing slide reading and providing patients' diagnosis. Therefore, the accuracy of the laboratory's test results for patients' histopathology procedures, cannot be assured. 2. The OM confirmed at approximately 12:00 p.m., that the laboratory did not have any record to verify its Mohs test accuracy for the years 2021 and 2022. 3. The laboratory's testing declaration form signed by the laboratory director, stated that the laboratory performs approximately 100 histopathology tests annually. D5309 TEST REQUEST CFR(s): 493.1241(e) If the laboratory transcribes or enters test requisition or authorization information into a record system or a laboratory information system, the laboratory must ensure the information is transcribed or entered accurately. 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 review of Mohs surgery samples slide preparations, final test reports, and interview with the office manager (OM); it was determined that the laboratory failed to transcribe or enter accurate information into a record system or a laboratory information system, the laboratory must ensure the information is transcribed or entered accurately. The findings included: 1. For one (1) out of five (5) random reviewed Mohs patient test results covering period from 8/16/2021 to 1/16/2023, one (1) patient had Mohs procedure dated 7/18/2022 and Mohs mapping report notes dated 6/13/2022 for the procedure taken place on 7/18/2022. 2. The OM confirmed on April 5, 223 at approximately 12:45 p.m. that the laboratory failed to ensure that the information transcribed was accurate on the Mohs notes. 3. The laboratory's testing declaration form signed by the laboratory director, stated that the laboratory performs approximately 100 Mohs tests annually. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on review of patient test records, laboratory's policy and procedure manual, and interview with the office manager (OM)); it was determined that the laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the post analytic systems. The findings included: 1. The laboratory did not have a written policy or procedure for quality assurance of patient management established for all the Mohs test performed in the laboratory. 2. Based on the laboratory's annual test declaration submitted and signed by the laboratory director at the time of the survey on April 5, 2023; the laboratory analyzed and reported 100 test results for which there was no quality assurance established policy to monitor accurate test results reporting during the postanalytic phase of testing. 3. The OM on April 5, 2023, at approximately 12:45 p.m. affirmed that the laboratory did not have a written policy or procedure for monitoring quality assurance for each test performed in the laboratory. -- 2 of 2 --