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 chemistry proficiency testing (PT) records and interview with the laboratory supervisor, the laboratory did not ensure that each step in the testing of the PT samples were maintained for the required 2 years. Findings: 1. The chemistry PT records from the third event of 2016 through the second event of 2018 (6 events) were reviewed. The laboratory's record system did not include the original instrument printouts with the PT records. 2. According to the laboratory supervisor the chemistry PT results are stored in the analyzers since they do not have a patient identification number and are not transferred to the laboratory information system (LIS). When the laboratory staff went to retrieve the PT results from the chemistry analyzers they were informed that the results are only stored on the analyzers for 30 days. The original PT values that were reported to the PT agency were no longer retrievable from the analyzers. 3. During the survey on 08/23/2018 at 3:00 PM the laboratory supervisor confirmed that the laboratory's record system did not ensure that the each step in the testing, original records of the chemistry PT results, were maintained for the required 2 years. 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 -- D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on interview with the laboratory (lab) technical consultant/supervisor, the lab did not establish policies to have the lab director assess this employee for the technical consultant/supervisor duties that they perform. The lab did not have records for this competency check and this was confirmed during interview with the technical consultant/supervisor in the afternoon of August 23, 2018. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) 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)