Summary:
Summary Statement of Deficiencies D5016 ROUTINE CHEMISTRY CFR(s): 493.1210 If the laboratory provides services in the subspecialty of Routine Chemistry, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1267, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of the Alfa Wasserman ACE Alkaline Phosphatase (ALP) reagent package insert, the manufacturer's quality control (QC) package inserts, the laboratory QC records, the Quality Control Program procedure, and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 1: 30 pm on 7/31/2023, the laboratory failed to verify the criteria for acceptable control ranges as specified in D5469 and failed to document