Urology Associates, Pc-Stonecrest

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of laboratory procedure, and staff interview, the laboratory failed to follow it's own procedure for processing patient samples for urine sediment examination when the centrifuge in use exceeded the speed and time specifications in the laboratory procedure in 2023. The findings include: 1. Observation of the laboratory on 11/07/2023 at 10:25 am revealed a Horizon Druker Diagnostics 642E centrifuge (serial 230413JA143) in use to process patient samples for urine sediment examination. The factory calibration sticker from 04/28/2023 indicated a speed of 3593 revolutions per minute (RPM) and a time of 15 minutes. 2. Review of the laboratory procedure titled " SIEMENS CLINITEK STATUS PLUS URINE DIPSTICK AND URINE SEDIMENT EXAMINATION" section "MICROSCOPIC EXAMINATION OF URINE SEDIMENT PROCEDURE" step two, revealed urine samples were to be centrifuged for five minutes at 400-450 G (1500-2000 rpm). 3. Interview on 11/07/2023 at 12:30 pm with the office manager and technical consultant confirmed the Horizon Druker Diagnostics 642E centrifuge used to process patient samples for urine sediment examination did not have speed and time settings that were consistent with the laboratory's procedure. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

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 on review of the proficiency testing(PT) procedure and interview with the Technical Consultant (TC) the laboratory failed to verify the accuracy of urine microscopic twice annually in 2018 and 2019. The findings include: 1. Review of the in-house proficiency testing procedure states "as part of Urology Associates Quality Assurance program testing personnel will be issued a split sample/blind Quality Control (QC) or quiz with color micrographs of entities found in urine sediment. This exercise will occur twice a year and fulfills the requirement for PT". 2. Interview with the TC on December 5, 2019 at 12:30 confirmed the laboratory did not verify the accuracy of urine microscopic twice annually in 2018 and 2019. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --