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 2019 American Association of Bioanalysts (AAB) and 2020, 2021, and 2022 American Proficiency Institute (API) proficiency testing (PT) records and interview with general supervisor (GS) 8/15/22, the laboratory failed to retain all records for at least two years from the date of the PT event. Findings: 1. Review of 2019 AAB PT records revealed the laboratory failed to retain graded results for 1 of 3 test events (Q2). During interview at approximately 2:20 p.m., the GS stated that when she first started working here, she was unable to access the AAB account set up by the previous TP. She stated she had to create a new account, so she should be able to print the 2019 Q2 graded results. 2. Review of 2020, 2021, and 2022 API PT records revealed the laboratory failed to retain the report form used to record PT results or documentation of online reporting for 5 of 5 test events (2020 1st and 2nd, 2021 1st and 2nd, and 2022 1st). D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) 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 -- Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of laboratory procedure, review of laboratory records, review of quality assessment (QA) documentation and interview with GS 8/15/22, the laboratory failed to retain calibration records for the toxicology testing performed on the Diatron Pictus 500 for a period of approximately 2 years, 8/9/19 through 9/29/21. Findings: Review of laboratory procedure "Calibration and Calibration Verification (Linearity)" revealed "Calibrations will be documented in the designated log book.". Review of laboratory records revealed no documentation of calibration performance for a period of approximately 2 years, 8/9/19 through 9/29/21. Review of QA documentation revealed "Laboratory Quality Assessment Review" forms completed by the GS. The forms stated review of calibration data was performed and results were acceptable. They also indicated calibration documentation would be printed at a later time. There was no documentation the calibration records were printed. For example: a. QA review form for January, February and March 2019 states "Calibrations reviewed in analyzer software; most calibrations were printed & in calibration book. Verified calibrations were done on analyzer computer.". b. QA review form for October, November and December 2019 states "Calibrations reviewed on analyzer computer; will be printed @ later date.". c. QA review form for January, February and March 2020 states "Calibrations from 2020 were not printed due to calibrations only held for 20 runs on analyzer. Reviewed calibration on analyzer 4/20/20 - all ok.". d. QA review form for October, November and December 2020 states "Calibrations reviewed on analyzer; all ok cals performed @ least monthly when QC & patient samples processed - will print later.". e. QA review form for July, August and September 2021 states "Calibration records reviewed on analyzer; will print later - all ok...". Interview with GS at approximately 12:30 p.m. confirmed calibration documentation was not printed and retained from 8/9/19 through 9/29/21. She stated the analyzer only goes back 20 calibrations. She also stated she discovered the flash drive was missing in August of 2021 so she was unable to retrieve or print calibrations previously performed and she notified admin of this problem on August 19, 2021. 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 review of the laboratory's policies and procedures and review of personnel records 8/15/22, the laboratory failed to ensure procedures were followed for evaluation of testing personnel (TP) competency. Findings: Review of the laboratory's "Personnel Competency Assessment" procedure states "... Six months and annually Laboratory staff who conducts the pre-analytical, analytical, and post-analytical phases of testing will be monitored as it applies to their specific duties, at six months and annually, to assure that they are competent to perform test procedures, and/or -- 2 of 5 -- report test results promptly and proficiently. The Competency Assessment form will be used to document the competency of the staff member. Any staff member found not to be competent in any area will be retrained in that specific area. ..." Review of the Competency Assessment form revealed the following methods of evaluation: "Direct observation of test performance", "Monitor test result recording & reporting", "Review of worksheets, QC, & Temp/hum records", "Instrument maintenance", "Assessment of test performance (PT/blind samples) records", "Assessment of problem-solving skills records". Review of personnel records revealed TP #1 (who also serves as general supervisor) was trained October-November 2018. Review of personnel records for TP #1 revealed technical competency evaluations performed 5 /30/19, 12/23/19, 12/28/20, and 12/23/21. The competency evaluations did not include documentation that the following required methods were utilized by the laboratory director to evaluate TP #1's competency: Direct observation of test performance, Assessment of test performance using proficiency samples or blind samples, and Assessment of problem solving skills. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of 2019 AAB and 2020, 2021, and 2022 API PT records and interview with the GS 8/15/22, the laboratory failed to review and evaluate all PT results received. 1. Review of 2019 AAB and 2020, 2021, and 2022 API PT records revealed the laboratory failed to document review and evaluation of graded results for 1 of 8 test events (2019 AAB Q3). There was no documentation of