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 proficiency testing (PT) records and interview with the laboratory manager, the laboratory did not ensure that all the PT records were saved for the last two years. Findings: 1. The PT records from 2017 and 2018 (5 events) were reviewed. The attestation sheets and PT worksheets for recording the test results prior to submitting to the PT agency were not available for the forensic urine drug- conformation (UDC), events UDC-B and UDC-C for 2017. 2. During the survey on 07 /25/2018 at 1:30 PM the laboratory manager confirmed that the PT attestation sheets and PT worksheets for UDC-B and UDC-C of 2017 were not available at the time of the survey. 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, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- consultant competency. This STANDARD is not met as evidenced by: Based on observation and interview with the general supervisor, the Director acting as technical supervisor did not perform competency assessments for the general supervisor. Findings: 1. It was observed that the lab did not have documentation showing competency assessments are made for the general supervisor to assess his supervisory duties assigned to him; and 2. This was confirmed with the general supervisor during interview at 1:00 pm on the day of survey. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation and interview with testing staff, the lab did not ensure reagents were not used past expiration. Findings: 1. It was observed that a bottle of acetic acid stored near the toxicology analyzers (LCMS analyzers) was labeled with an expiration date of January 31, 2018; 2. It was confirmed during interview with the testing person at 1:30 pm on the day of survey, that the acetic acid was expired and was not labeled as do not use for patient testing. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on review of the "Proficiency Testing between LC-1/LC-2" procedure and interview with the manager, the laboratory's written procedure did not define the frequency of comparisons to be performed between the two Liquid Chromatography- Mass spectrometry (LC-MS) analyzers used at the laboratory. Findings: 1. The laboratory has two LC-MS analyzers that report patient results on any given day. The "Proficiency Testing between LC-1/LC-2" procedure does not define the frequency that the comparisons are to be performed and evaluated. 2. During the exit interview on 07/25/18 at 1:30 PM the manager confirmed that the "Proficiency Testing between LC-1/LC-2" procedure did not define the frequency that the comparisons were to be performed. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are -- 2 of 4 -- reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require