Summary:
Summary Statement of Deficiencies D0000 A routine recertification survey was conducted at Mountain State Medical Specialties, PLLC, on July 9, 2025, by the West Virginia Office of Laboratory Services. The laboratory was assessed and for compliance with the CLIA regulations under 42 CFR 493, Requirements for Laboratories. 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 review of laboratory policies and procedures, proficiency testing (PT) records, lack of documentation, interview with the general supervisor (GS), and exit interview with the laboratory director (LD), the laboratory failed to verify the accuracy of testing twice in 2024 and failed to complete any accuracy verifications in 2025 for Histopathology. Findings: 1. Review of "Proficiency Testing" procedure identified "Two (2) times a year the lab will submit five (5) cases to all MSMS physicians who read slides" as an in-house program for verification of accuracy in Histopathology. 2. Review of 2024 PT records revealed one in-house accuracy evaluation documented (labeled 2024, no month stated). No second accuracy evaluation for 2024 could be located. 3. Review of 2025 PT records (January thru date of survey) revealed one in-house accuracy evaluation in the process of being completed. 4. During an interview with the GS, 7/9/25 at 10:30 AM, the GS agreed that no accuracy verification for Histopathology was performed and documented twice in 2024 and the one 2025 accuracy verification was incomplete. 5. An exit interview with the LD, 7/9/25 at 11:40 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 --