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 review of the urinalysis microscopic procedure, observation of the urinalysis centrifuge and interview with the laboratory director, the laboratory failed to follow instructions for urine microscopic testing. Findings: 1. Review of the urinalysis microscopic procedure showed the laboratory must centrifuge urine for urine microscopic exams between 1900-2400 revolutions per minute (RPM). 2. Observation of the urinalysis centrifuge revealed, the centrifuge spins at 3300 RPM. 3. Interview with the laboratory director on November 20, 2018 at 10:00 AM confirmed, the laboratory failed to centrifuge urine at the speed stated in the procedure manual. 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 --