Summary:
Summary Statement of Deficiencies D6177 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1495(b)(3) Each individual performing high complexity testing must adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed. This STANDARD is not met as evidenced by: Based on a record review and an interview with the testing personnel (TP), the lab failed to adhere to the laboratory's quality control (QC) policies, which required staff to document lot numbers and expiration dates of hematoxylin and eosin (H&E) stains since the last survey on 06/01/2021. Findings include: 1. Review of the laboratory's QC logs revealed that the lot numbers and expiration dates of H&E stains were not documented. 2. An interview with the TP on 01/04/2024, at 10:30 a.m., confirmed that this information was not documented. 3. The laboratory performs approximately 33 histopathology tests annually. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --