Summary:
Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of the College of American Pathologists (CAP) Next-generation sequencing (NGS)-Germline proficiency testing (PT) records and interview with the general supervisor (GS), the laboratory failed to ensure that the laboratory staff signed the attestation worksheet showing that PT samples were tested in the same manner as the patients. Findings: 1. The CAP NGS PT records from 2023 and 2022 (3 events) were reviewed. Three of three of the PT attestation worksheets showed that the name of the laboratory director (LD) and testing personnel (TP) were typed on the worksheets. The worksheets failed to include the signature of the laboratory director and TP per the CAP PT instructions. 2. During the survey on 08/11/2023 at 12:30 PM, the GS and LD confirmed that the PT attestation worksheets failed to have the signature of LD and TP involved in the performance and interpretation of the PT results. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)