Standard - Laboratory Procedure Manual

(A) There shall be available at all times, in the immediate bench area, to personnel engaged in examining specimens and performing related procedures within a category (e.g., clinical chemistry, hematology, pathology, etc.), current laboratory manuals or other complete written descriptions and instructions for all automated and manual test procedures which are performed by the laboratory. Procedures shall include: (1) The analytical methods used by those personnel, properly designated and dated to reflect the most recent supervisory review; (2) Reagents; (3) Control and calibration procedures; (4) Pertinent literature references. Textbooks may be used as supplements to such written descriptions but shall not be used in lieu thereof. Each procedure shall be reviewed and dated by the technical supervisor at least annually. Written approval shall be given by the director or supervisor of all changes in laboratory procedures. (B) Procedures which assure a reasonable turnaround time for all test results and provide for alternative testing mechanisms in the event that equipment or methods become inoperable shall be established for each test performed in the laboratory.