TABLE 19.

Roles and responsibilities for analytical processes

Activity(ies)	Role(s) and/or responsibility(ies)
	Institution	Microbiology laboratory management	Microbiology staff
Test method selection	Provide budget, staff, and other resources	Select new procedures for patient population	Perform test method comparison studies
	Suggest new testing based on customers' feedback	Review send-out tests to decide if testing can be performed in-house
Test method verification and validation	None	Develop, review, and approve verification and validation protocols and data	Perform verification or validation testing
		Retain all records of verification and validation studies and raw data
Maintenance current version of SOPs	None	Create and approve test method procedures	Review procedures by comparing actual practice to what is written in the SOP
		Periodically review and revise SOPs
		Ensure that current version of SOP is available to staff
		Archive obsolete versions of SOPs
Establishment of measurement of uncertainty for quantitative test methods	None	Review all test parameters that would contribute to variation in the test result	Perform test as specified and do not deviate from established protocol
		Minimize variations in sample, test procedure, the environment, personnel, and reporting