Summary:
Summary Statement of Deficiencies D0000 A validation survey was performed on May 18-19,2026, with the following standard level deficiencies cited. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. In addition, retain the following: This STANDARD is not met as evidenced by: Based on review of the laboratory's mean of the normal patient range (MNPT) study and interview with Technical Consultant #3, the laboratory failed to retain their questionnaire to determine if normal patients were used when the laboratory changed thromboplastin in 2025 with 1 of 1 reviewed lot changeovers for coagulation as evidenced by: 1. The laboratory could not provide documentation of their questionnaire to determine if normal patients were being used when the laboratory changed thromboplastin on August 14,2025. 2. In interview with the technical consultant #3 on 5-19-2026 at 1201, she confirmed that they ask their patient questions to make sure they are not on anti-coagulants but could not provide any documentation for the lot change in 2025. 3. The laboratory performs 20,967 prothrombin times test (PT) per year. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of