Summary:
Summary Statement of Deficiencies D0000 An initial certification survey was conducted on February 5, 2025, for Charter Dermatology PLLC by the West Virginia Office of Laboratory Services. The laboratory was assessed for compliance with the CLIA regulations under 42 CFR 493, Requirements for Laboratories. Specific deficiencies cited are explained below. D5313 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(b) (b) The laboratory must document the date and time it receives a specimen. This STANDARD is not met as evidenced by: Based on review of the MoHs specimen log, patient MoHs testing records, and interview with the laboratory manager for the MoHs laboratory, the laboratory failed to document the time of receipt into the laboratory for 22 of 22 patient MoHs specimens in 2025. Findings: 1. Review of the 2025 MoHs patient specimen log identified 22 patient specimens were processed and tested under the laboratory's MoHs protocol. No documented time of when the 22 specimens were received by the laboratory could be located on the specimen log. 2. Review of the 22 patient MoHs maps and final report records identified no time of receipt into the laboratory for 22 of 22 specimens documented on the records. 3. During an interview, 2/5/25 at approximately 8:45 AM, the laboratory manager verified that no documentation of the time MoHs specimens are received into the laboratory could be located for the 22 specimens. 4. An exit interview with the laboratory director, 2/5/25 at approximately 9:40 AM, 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 --