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 office administrator, the laboratory failed to follow the laboratory's Quality Control (QC) policy, which required testing personnel to document lot numbers and expiration dates for the stains used in the hematoxylin and eosin (H&E) staining procedure used for histopathology slides since the last survey on 2/8/2021. Findings include: 1. A review of the QC policy revealed that the laboratory testing personnel failed to follow the instructions for documenting lot numbers and expiration dates for the reagents used in the H&E staining procedure. 2. A review of the laboratory's quality control log for H&E stains revealed the laboratory did not write the lot numbers and expiration dates since the last survey on 2/8/2021. 3. The laboratory performed approximately 260 histopathology tests per year. 4. An interview with the office administrator on 01/03 /2024, at 10:30 a.m., confirmed that the laboratory did not document the dates and lot numbers for staining reagents. 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 --