Summary:
Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on a review of the API (American Proficiency Institute) proficiency testing (PT) records, the policies and procedures manual, and an interview with the Laboratory Manager (also Testing Personnel [TP] #1), the surveyor determined the laboratory failed to ensure PT specimens were tested the same number of times as patient samples. This was noted on one of three 2017-2018 survey events reviewed. The findings are: 1. A review of the API proficiency testing (PT) records revealed the 2018-Event #2 Urine Drug Screen survey samples were run twice on 10/19/2018. A review of the instrument printouts revealed a morning run with results for UDS-04, -05, and -06 printed at 9:35 AM, and then an afternoon run with results printed at 1:58 PM. Both TP #1 and TP #2 had signed as the testing personnel on the attestation statement. 2. A review of the Proficiency Testing "General Guidelines" in the policies and procedures manual revealed, "...Analyze PT specimens according to patient protocols at all times throughout the process. For example, if a patient specimen is routinely tested only once, then do the same with the PT specimens: test only one time. ...". 3. In an interview on 2/13/2019 at 11:00 AM, the surveyor asked the Laboratory Manager if patient samples are usually tested twice by two different testing personnel on the same day. The Manager confirmed patient samples are 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 -- usually run once, however he had used the PT samples to check the competency of TP #2. The surveyor explained a laboratory should only use PT samples to establish competency after the required submission deadline has passed. Thus, the above noted findings were confirmed. SURVEYOR ID#32558 Licensure and Certification Surveyor -- 2 of 2 --