Aistheta Reno Medical Skin Care Center

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on July 19, 2024. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on a random review of the laboratory's accession logs and histopathology slides from September 13, 2022 through May 21, 2024, the laboratory's policies and procedures, and an interview with the office manager, the laboratory failed to follow the director approved policy for ensuring positive patient identification for histopathology slides throughout the testing process. Findings include: 1. A random sample of six histopathology patient records and slides from September 13, 2022 through May 21, 2024, revealed a patient's case number from September 13, 2022 was documented as 22-249 on the accession log. The label affixed to the slide indicated case number 22-429. The case number 22-249 had been used for a different patient on June 7, 2022. 2. A random sample of six histopathology patient records and slides from September 13, 2022 through May 21, 2024, revealed a patient's case number from May 23, 2023 was documented as 23-251 on the accession log. The label affixed to the slides indicated case number 23-250. The case number 23-250 had been used for another patient on May 23, 2023. 3. The director approved policy indicated that 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 -- case numbers were to be sequential and unique to each patient encounter. 4. An interview with the office manager on July 19, 2024, at approximately 2:30 PM confirmed these findings. The laboratory performs approximately 500 histopathology tests annually. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on the laboratory's quality assurance checklist, a random review of the laboratory's accession logs, histopathology slides, and an interview with the office manager, the laboratory failed to establish and maintain a system to detect and correct errors in quality as they occurred. Findings include: 1. A review of the laboratory's quality assurance checklist titled, "Integrated Dermatology Review and Verification Log" found that the laboratory was to review slides weekly for accuracy. This review was to include the name, specimen site, case number assigned and number of slides generated. 2. The laboratory failed to identify errors in the case numbers documented on the accession log and on the histopathology slides. The laboratory documented that quality assurance had been performed on the weeks when the errors occurred. 3. A random sample of six histopathology patient records and slides from September 13, 2022 through May 21, 2024, revealed a patient's case number from September 13, 2022 was documented as 22-249 on the accession log. The label affixed to the slide indicated case number 22-429. The case number 22-249 had been used for a different patient on June 7, 2022. 4. A random sample of six histopathology patient records and slides from September 13, 2022 through May 21, 2024, revealed a patient's case number from May 23, 2023 was documented as 23-251 on the accession log. The label affixed to the slides indicated case number 23-250. The case number 23-250 had been used for another patient on May 23, 2023. 5. An interview with the office manager on July 19, 2024, at approximately 2:30 PM confirmed these findings. The laboratory performs approximately 500 histopathology tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on 6/29/18. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D5315 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(c) The laboratory must refer a specimen for testing only to a CLIA-certified laboratory or a laboratory meeting equivalent requirements as determined by CMS. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the laboratory director, the laboratory did not have documentation that the reference laboratories used for the twice per year accuracy checks for the reading of histopathology slides were CLIA- certified laboratories or met equivalent requirements as determined by CMS. Findings include: Laboratory records reviewed did not indicate the CLIA numbers of the laboratories used for the twice per year accuracy checks for the reading of histopathology slides for Mohs and dermatopathology diagnosis. The laboratory director interviewed during the on-site survey on 6/29/18 at approximately 2:30 PM indicated that he would obtain the CLIA numbers of the laboratories but did not submit the information to the inspector to date. The laboratory performs approximately 400 histopathology tests annually. 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 --