Derm One Pllc

Summary Statement of Deficiencies D0000 An announced, on site, routine recertification survey was conducted at Derm One PLLC on January 12, 2023, by the West Virginia Office of Laboratory Services. The laboratory was surveyed to assess compliance with the Federal Clinical Laboratory Improvement Amendment (CLIA) regulations under 42 CFR 493. Specific deficiencies cited are explained below. 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 record review and interview the laboratory failed to document the biannual evaluation and comparison for alternative accuracy verification of the MOHs procedure for one of two events in 2021 and two of two events in 2022. Findings: 1. Review of 2021 MOHs accuracy verification logs and records identified no documentation of the comparative evaluation between the outsourced diagnosis and the in house diagnosis for the second event in 2021. 2. Review of 2022 MOHs accuracy verification logs and records identified no documentation of the comparative evaluation between the outsourced diagnosis and the in house diagnosis for two of two events in 2022. 3. An interview with the laboratory manager, 1/12/23 at approximately 10:30 AM, confirmed the lack of documentation for the evaluation of the alternative accuracy verification process. 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 D6082 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(1) The laboratory director must ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing. This STANDARD is not met as evidenced by: Based on review of quality assessment records and interview with Office Manager (OM) and histotechnician (HT), the laboratory director did not ensure that test systems used for all aspects of testing were reviewed by qualified personnel. Findings: 1. Laboratory Quality Assessment Review Chart which documented quality indicators for pre-analytic, analytic and post-analytic phases of testing was available but there was no evidence found of director review for 2017 and 2018. The OM and HT could not sign this document the Technical Supervisor or Laboratory Director. . 2. Quality Chart Logging Checks were found which documented accuracy of patient test management. The checks were performed using the information from 5 patient charts, 3X per year. There was no evidence of director review of these documents for 2017 and 2018. 3. Daily H & E Stain Quality Control was documented by HT. However, there was no evidence of director review for 2017 and 2018. 4. Various temperature charts documenting room temperature, Cryostat temperature, and humidity, plus eye wash and general maintenance charts were found. However, there was no evidence of director review. 5. The OM and HT agreed that the documents were not signed as reviewed by the Laboratory Director/Technical Supervisor. 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 --