Atrium Health Wfb Family Medicine Laboratory

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation and interview with the TC (technical consultant) 3/19/26, the laboratory failed to discard supplies that exceeded their expiration date. During a tour of the laboratory at approximately 12:40 p.m., the surveyor observed 9 Vacuette yellow top tubes (lot #A2409454, expiration date 3/15/26) on the counter, available for use. During interview at approximately 12:45 p.m., the TC confirmed the tubes were expired. She stated the laboratory had used some of the expired tubes to send patient specimens to an outside laboratory for testing. 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 --

Summary Statement of Deficiencies D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures and interview with the TC (technical consultant) 6/26/19, the laboratory director failed to ensure the establishment and maintenance of a comprehensive quality assessment program designed to identify and correct problems and assure the quality of laboratory services provided throughout all phases of the testing process (preanalytic, analytic, and postanalytic). Review of the laboratory's policies and procedures revealed there were no written quality assessment policies or procedures available. During interview at approximately 2:45 p.m., the TC stated they routinely review quality control and proficiency testing records and document