The performance-based measurement system (PBMS) is a new
approach developed by the US Environmental Protection
Agency (USEPA) to modify analytical methods. Method modifications
are made to improve performance, increase laboratory efficiency,
or reduce costs, outcomes that should ultimately lead to
better quality water data. USEPA methods 1622 and 1623 are the first
of the agency's microbiological methods to be modified by PBMS.
Laboratories and manufacturers have two avenues for introducing
method modifications to improve performance or efficiency.
Tier 1 validation is used when an individual laboratory
wants to alter a component or step in the method for in-house
use. Tier 2 validation is used when a manufacturer or other organization
wants to demonstrate acceptable performance of a modified
version of the method for nationwide use.
The PBMS approach to method flexibility is straightforward in
principle, but the actual "how-to" of applying the approach can be
confusing, even for those laboratories conducting tier 1 studies.
This article details how to use PBMS, including conducting modified
method acceptability studies, and offers case studies of
successful and unsuccessful modification outcomes. Includes 20 references, tables.