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 a review of the laboratory procedure manual, random review of environmental monitoring records, and staff interview, the laboratory failed to follow its humidity monitoring procedure for four of four months reviewed in 2023 and 2024. The findings include: 1. A review of the laboratory's "Reagent and Supply Management & Environmental Monitoring of Temperature and Humidity" policy revealed the following: - "Refrigerator, humidity and Room temperature will monitored and recorded each day of testing." - "Is the current temperature/humidity in Range as defined on the daily log? If no proceed to step 6." - Step 6: "Run QC and document if results are acceptable or not on the temperature log." - "Always document if QC was acceptable and if instrument function checks were acceptable when documenting