Summary:
Summary Statement of Deficiencies D3033 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3)(i) In addition, the laboratory must retain records of test system performance specifications that the laboratory establishes or verifies under 493.1253 for the period of time the laboratory uses the test system but no less than 2 years. This STANDARD is not met as evidenced by: Based on review of laboratory records, and confirmed in interview of laboratory personnel, the laboratory failed to retain the original EQC documents used to complete its Individualized Quality Control Plan (IQCP) for cardiac markers Troponin and CK-MB. The findings included: 1. Review of the laboratory's IQCP for Troponin and CK-MB found the laboratory did not retain the original Equivalent Quality Control (EQC) records used to develop its IQCP that it performed to reduce the frequency of external quality control testing to each new lot, each new box, and every 30 days of patient testing. 2. The laboratory was asked to provide documentation of retaining the original EQC documents used to perform the IQCP for Troponin and CK- MB. No documentation was provided. 3. An interview with the office manager and technical consultant on December 2, 2021 at 11:00 hours in the Marketing Office confirmed the findings. The office manager confirmed the records could not be located. D5785