Summary:
Summary Statement of Deficiencies D3013 FACILITIES CFR(s): 493.1101(e) Records and, as applicable, slides, blocks, and tissues must be maintained and stored under conditions that ensure proper preservation. This STANDARD is not met as evidenced by: Based on the lack of a policy and procedure for retention requirements and an interview with the laboratory personnel (LP) on July 14, 2026, it was determined that the laboratory failed to establish a policy for retention requirements applicable to Hematology as required in CFR 493.1105(a). The findings include: 1. The laboratory lacked a retention policy and procedure for all types of records applicable to Hematology as required in CFR 493.1105(a). 2. The LP confirmed in an interview on July 14, 2026, at approximately 9:45 a.m. that the laboratory lacked the retention policy and procedure to store all types of records as required. 3. According to the laboratory testing declaration form (Lab-144) submitted at the time of the survey, the laboratory processed and reported approximately 180 Hematology samples annually. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on the review of the laboratory's policy and procedure, American Association of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE) proficiency testing (PT) records, lack of