21 CFR 606.65 states, "Supplies and reagents shall be used in a manner consistent with instructions provided by the manufacturer."
The correct answer is A. The reagents must be used according to the manufacturer's instructions for use. If the instructions say one or two drops may be used and the facility procedures also allow one or two drops, then there is no problem with the staff members choosing to use two drops.
While equipment must be calibrated, it does not generally influence the number of drops used.
Staff members often ask co-workers and colleagues from other facilities how to perform tasks, but it is the manufacturer's instructions for the operation of equipment and the use of reagents that must be followed.
A laboratory employee who is performing an internal audit of routine ABO and Rh typing procedures notes that a technologist places two drops of Anti-D in a tube, centrifuges the tube for 20 seconds, and reads the reaction using a magnifying mirror. When questioned about the procedure, the technologist indicates that most staff use two drops of Anti-D reagent because the reactions are stronger with two drops. In addition to reviewing the facility procedure manual, what should be done to ensure regulatory compliance?
Submit