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 record review and interview with the Administrative Laboratory Director, the laboratory failed to have written procedures for its magnesium testing using the Vitros 7600 analyzer for 2 (April 2022 to April 2024) of 2 years reviewed. Findings include: 1. A review of the laboratory's test menu revealed the laboratory performed magnesium testing. 2. A review of the laboratory's chemistry test procedures using the Ortho Vitros 7600 analyzer revealed it lacked procedures to perform magnesium testing. 3. An interview on 4/3/24 at 12:59 pm with the Administrative Laboratory Director confirmed a test procedure for magnesium was not established. 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 --