Summary:
Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based upon a review of lab policies, test accuracy verification records and an interview with the Laboratory Director (LD), the laboratory failed to perform test accuracy verification twice annually. Findings were as follows: 1. The surveyor was presented with a binder titled "Urology One Standard Operating Procedure Manual". The binder contained a document titled " Policy: Quality Assessment/Peer Review" which revealed the following statement: "2. Individual pathologists will be evaluated through a review processing the Proficiency section of the SOP. This includes second opinions where the diagnosis isn't shared and peer review. This will include a minimum of 16 cases per year." 2. The surveyor requested test accuracy verification records for 2017 and 2018. A document titled "PT Blind review" was provided which contained 9 selected cases for accuracy assessment which were forwarded to P4 Diagnostix for peer review. Nine cases selected: 20195 18025 20944 01490 02388 00250 16888 16887 17006 2. The "PT Blind review" sheet did not contain any dates of submission, only 3 peer review signatures without dates, and no LD review and date. The laboratory director verified no dates for peer review had been documented during 2017 and 2018. The interview occurred on 10/10/2018 at 2:00 PM. 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