Summary:
Summary Statement of Deficiencies D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's Levey Jennings (LJ) quality control (QC) records, and interview with the laboratory testing personnel and the laboratory director, it was determined that the laboratory failed to take actions when monitoring over the cumulative QC date between 01/21/2020 and 01/30/2020 LJ chart for the analyte including, but are not limited to the followings: Alpha -OH alprazolam (AH), Alprazolam (AL), 7-Aminoflunitrazepam (AF), and 7-Aminoclonazepam (AC). The laboratory failed to document all