Summary:
Summary Statement of Deficiencies D0000 Validation survey A validation survey was performed on April 28,2026, with the following standard level deficiencies cited. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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 laboratory's policy and procedures, textbook reference, direct observation, and interview with Laboratory Director, the laboratory failed to have textbook references in their procedure while performing microscopic urines for the last year as evidenced by: 1. In review of laboratory's policy and procedures Titled, "Test Name Urinalysis using Clinitek Status +", the laboratory had a combine procedure with microscopic urines. Step 13 and 14 stated the following, "Pour 3 mls of specimen into a clean, labeled centrifuge tube, Centrifuge for 3 minutes at 3,000 revolutions per minute (RPM)'s." The laboratory did not have any references in the procedure to addressing centrifuge speed and time. 2. In review of the laboratory's textbook procedure provided to the surveyor, Urinalysis and Body Fluids by Strasinger pg. 89 stated, "A standard amount of urine, usually between 10 and 15 mls, is centrifuged in a conical tube... Centrifugation for 5 minutes at a relative centrifugal force (RCF) of 400 will produce an optimum amount of sediment with the least chance of damaging elements." 3. In direct observation at 0935, the Bench top horizon 6 Flex #CNT251 was set at 3000 RPM for 3 minutes with a relative centrifugal force of 1100 (Xg). 4. In an interview with the Laboratory Director at 0941 confirmed that Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- she didn't have a reference in a procedure and was not sure where the specifications came from. 5. The laboratory had an annual volume (2025) of 1447 microscopic urines per year. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)