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 alternate proficiency testing (PT) records and interview with the technical supervisor (TS), the laboratory did not ensure that the documentation of the alternate PT records included the date of testing, who performed the tests, the source of the samples sent for analysis and the name of the laboratory that performed the alternate PT. Findings: 1. According to the TS the alternate PT procedure requires the laboratory to retest 5 patient specimens along with 5 standards used for calibration of the liquid chromatography with tandem mass spectrometry (LC/MS/MS) analyzer. These results are compared to the in-house testing 2. The alternate PT records from one event in 2019 were reviewed. The records did not include the date the specimens were tested in-house. The records did not included who performed the tests in-house. The source of the patient samples and standards tested in-house were not identified on any of the alternate PT records in ensure authenticity of the results that were compared. The worksheets did not include the name of the laboratory performing the PT. 3. During the survey on 01/28/2020 at 2:30 PM the TS confirmed that alternate PT records did not include the date of testing, name of the laboratory, who performed Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- the tests, the source of the samples used for the alternate PT testing on the LC/MS /MS. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of