Summary:
Summary Statement of Deficiencies D0000 A routine recertification survey was conducted at Hardy County Medical Services on September 10, 2025, 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. 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, and interview with testing personnel (TP1), the laboratory failed to complete any accuracy verifications in 2025 for Histopathology. Findings: 1. Review of "Proficiency Testing" procedure identified "semi-annually, the tech or manager will randomly select and send two cases containing the original slides, label it with only the surgical number, and send it over for a microscopic examination by a Board Certified Dermatopathologist" as an in-house program for verification of accuracy in Histopathology. 2. Review of 2025 PT records (January thru date of survey) revealed slides for an in-house accuracy evaluation were sent to Rabkin for review on 8/4/2025. No documentation the accuracy evaluation for Histopathology was completed could be located. 3. During an interview with TP1, 9 /10/2025 at 9:20 AM, TP1 agreed that no accuracy verification for Histopathology had been completed for 2025. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test 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 -- procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)