Summary:
Summary Statement of Deficiencies D0000 An announced, on site, initial certification survey was conducted at University Physicians & Surgeons, Inc. DBA Marshall Dermatology on June 24, 2021, 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. D6170 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(a) Each individual performing high complexity testing must possess a current license issued by the State in which the laboratory is located, if such licensing is required. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to ensure that high complexity testing personnel possessed a valid West Virginia laboratory license, as required by the state rule WV 64 CSR 57 Clinical Laboratory Technician and Scientist Licensure and Certification Rule. Findings: 1. Review of personnel files, including 2021 initial training and 2021 initial competency, revealed 1 of 1 testing personnel (TP1) performed high complexity inking and mapping of MOHs specimens. No valid West Virginia laboratory license could be located. 2. During an interview with TP1, on 6/24/2021, at approximately 8:40 AM, TP1 confirmed that high complexity procedures (inking, mapping) had been performed on patient specimens and that they had no current West Virginia laboratory license. 3. The laboratory director confirmed the findings during the exit interview 6/24/2021 at approximately 10:15 AM. 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 --