Summary:
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 manufacturer instruction manual, review of laboratory procedure, and staff interviews, the laboratory failed to follow it's own procedure for processing patient samples for urine sediment examination when the centrifuge in use did not meet the requirements in the procedure for 2022 and 2023. The findings include: 1. Observation of the laboratory on 12/01/2023 at 9: 40 am revealed a Frontier 5306 (Serial #B520002678) centrifuge in use to process patient samples for urine sediment examination. 2. Interview with testing person one on 12/01/2023 at 9:45 am revealed the following: The laboratory uses the Frontier 5306 centrifuge to process urine samples in preparation for urine sediment examination. A volume of 2 milliliters (mL) is used. 3. Review of the Frontier 5306 Instruction Manual revealed the maximum sample volume was two mL and the centrifuge speed was 6000 revolutions per minute (RPMs). 4. Review of the laboratory procedure titled "Urine Sediment Examination" revealed the sample was to be processed using a sample volume of six mL and centrifuged at 3000 RPM for five minutes. 4. Interview on 12/01/2023 at 12:00 pm with the technical consultant confirmed the laboratory failed to process urine samples for urine sediment examination according to the established procedure in 2022 and 2023. 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 --