Summary:
Summary Statement of Deficiencies D0000 An initial certification survey was conducted at Blue Ridge Cancer Care Princeton on May 27, 2025, by the West Virginia Office of Laboratory Services. The laboratory was surveyed to assess for compliance with the CLIA regulations under 42 CFR 493, Requirements for Laboratories. Specific deficiencies cited are explained below. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, testing personnel (TP1 and TP2) competency records, interview with the laboratory manager, and interview with the laboratory director (LD), the laboratory failed to establish a written protocol for the assessment of competency for testing personnel performing manual peripheral blood smear review. Findings: 1. Review of the policies and procedures manual "CLIA Compliance" revealed no written protocol for the competency assessment of testing personnel performing manual peripheral blood smear review. 2. Review of TP1 and TP2 2025 competency records identified competency assessments performed 2/10/2025. 3. During a phone interview with the laboratory manager, 5/27/25 at 3:00 PM, the laboratory manager agreed there was no written policy or procedure for the process of documenting competency for testing personnel performing manual peripheral blood smear review. 4. An exit interview with the LD, 5/27/2025 at 3:40 PM, confirmed the lack of written protocol for competency assessment of testing personnel. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) 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 -- (b) The procedure manual must include the following when applicable to the test 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)