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 proficiency testing records review, lack of documentation, and interview with staff, the laboratory failed to ensure testing personnel sign the proficiency testing attestation statement to affirm proficiency testing was performed in the same manner as patient testing for 9 of 9 testing events reviewed from November 2018 to November 2020. Findings include: 1. Proficiency testing records review lacked the testing personnel's signature attesting they performed proficiency testing in the same manner as they performed patient testing for Immunoassay and gas chromatography /Mass Spectrometry testing for American Proficiency Institute 1st and 2nd events of 2019 and 2020 and the College of American Pathology DMPM A,B, and C of 2019 and events A and B of 2020. 2. In an interview with staff on 11/17/2020 at approximately 1:30 P.M. staff confirmed one staff member typed in the names of all testing personnel performing testing when entering proficiency test 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 2 -- 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)