Summary:
Summary Statement of Deficiencies 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 laboratory records, lack of documentation and interview with the technical consultant (TC), the laboratory failed to have available written procedures for the testing of 2 of 39 chemistry analytes (Potassium (K)) and Sodium (Na)) listed on the "Lab Express Corporation...Non Waived Test List" affecting over 20,116 tests. Findings include: 1. Review of the "Lab Express Corporation...Non Waived Test List" revealed 39 chemistry analytes utilized for patient testing. Albumin, Alkaline phosphatase, Alanine transaminase, Aspartate aminotransferase, Total carbon dioxide, Direct Bilirubin, Total Bilirubin, Calcium, Chloride, Cholesterol, Creatinine, Urine Creatinine, C - Reactive Protein, Glucose, Hemoglobin A1C, High - Density Lipoprotein cholesterol, Iron, Low - Density Lipoprotein cholesterol, Magnesium, Phosphorous, Total Protein, Urine Protein, Potassium, Recombinant Human C - Reactive Protein, Sodium, Total Iron-Binding Capacity, Triglyceride, Urea Nitrogen, Uric Acid, Vancomycin, Valproic Acid, Ferritin, Folate, Free T4, Free T3, Total Prostate-Specific Antigen, Thyroid-stimulating hormone, Vitamin B12, and Vitamin D 2. Review of the laboratory's procedure manual revealed the laboratory failed to make available written procedures for the testing of 2 of 39 chemistry analytes, K and Na. 3. Review of patient test records documented 20,116 patient tests were performed for K and Na from January 2024 to January 2025. 4. On 01/14/2025, the TC confirmed the lab failed to have procedures available for testing K and Na. D5403 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 2 -- 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)