Summary:
Summary Statement of Deficiencies D5014 GENERAL IMMUNOLOGY CFR(s): 493.1208 If the laboratory provides services in the subspecialty of General immunology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of the laboratories policies and procedures, quality control (QC) records, verification of performance specification records, patient specimen logs, and confirmed by interview with the Laboratory Director (LD), the laboratory failed to: have procedures as specified in D5403; ensure approval of laboratory procedures with a date and signature by the LD as specified in D5407; verify the performance specifications of accuracy and precision for human immunodeficiency virus (HIV) 1/2 antigen/antibody testing as specified in D5421; perform two levels of QC at least once each day of patient testing as specified in D5449; ensure QC results meet the laboratory's criteria for acceptability before reporting patient test results as specified in D5481; take and document