Summary:
Summary Statement of Deficiencies D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on record review and an interview with the Laboratory Manager, the laboratory failed to document quality control (QC) for the high complexity patient tissue biopsy slide interpretation testing. This deficient practice had the potential to affect 106 out of 106 patients tested from 02/21/2024 through 05/28/2024 in the speciality of Histopathology. Findings Include: 1. The inspector requested the laboratory's policy and procedures for documenting daily QC for the patient tissue biopsy slide interpretation testing. 2. Review of the laboratory's policies and procedures found the following: "...Quality Control: [Laboratory Director] will acknowledge the receiving of slides while the lab manager will acknowledge the return of slides by initialing paperwork that will be sent with the slides daily. Any problems will be addressed directly with the lab manager as well as documented on the daily quality control paperwork..." 3. The surveyor requested daily QC documentation of the patient tissue biopsy slide interpretation testing. 4. The Laboratory Manager confirmed that the laboratory failed to document daily QC of patient tissue biopsy slide interpretation testing. The interview occurred on 05/28/24 at 12:32 PM. 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 --