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 the laboratory's test menu, review of the laboratory's procedure manual, and staff interview, the laboratory failed to have procedures for two of twelve assays performed. The findings included: 1. A review of the laboratory's test menu identified twelve assays performed on the Siemens Viva-E instrument. Two of twelve assays were introduced by the laboratory in 2023. They were: a) EDDP performed: 10 /2023 to 3/2024 b) Tramadol performed: 12/7/2023 to current 2. A review of the laboratory's procedures determined the laboratory failed to have documentation of procedures for EDDP and Tramadol. 3. Testing personnel number 1 (as listed on Form CMS 209) confirmed the findings in an interview conducted on 04/09/2025 at 1230 hours in the conference room. Key EDDP: 2-ethylidene-1,5-dimethyl-3,3- diphenylpyrrolidine D5783