Bluefield Gastroenterology Pllc

Summary Statement of Deficiencies D0000 A routine recertification survey was conducted at Bluefield Gastroenterology Pllc. on December 13, 2023, by the West Virginia Office of Laboratory Services. The laboratory was assessed for compliance with the Federal Clinical Laboratory Improvement Amendments (CLIA) regulations under 42 CFR 493. Deficiencies cited are explained below. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (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. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies 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 a review of personnel records, written laboratory policies and procedures, and an interview with Testing Personnel 1 (TP1), the laboratory failed to follow written policy/procedure and assess employee competency on an annual basis. Findings: 1. A review of written laboratory policies and procedures revealed an employee competency assessment policy that stated "each employee who works in the histology laboratory is required to pass a competency test annually." 2. A review of personnel records identified a lack of annual employee competency for TP1. The last annual competency documented was 10/17/16. 3. An interview with TP1, on 8/22/19 at approximately 11:00 AM, confirmed that no annual employee competency had been performed since 10/17/16. 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 --