“Minimum” or “appropriate” quality standards ?

The term minimum standard is often used to describe the least permissible condition or procedure required to demonstrate a basic level of performance (or provision of test results in the current context). In circumstances where quality is not considered a primary objective, minimum usually becomes synonymous with actual. When discussing any testing situation where quality is an important component of the expected outcome, appropriate standard(s) which provide the desired level of measurement uncertainty are required.

For POC and quantitative pathology testing in general, appropriate analytical tolerance levels are defined by quality goals based on biological variation or internationally recognized clinical decision values as described previously. The desirable analytical variability which is required to insure that a test is fit for purpose is fully discussed by Fraser²⁵,²⁶,⁸⁷, Fraser and Scott²⁷, and White and Farrance²⁴ Failure to meet appropriate standards and failure to demonstrate that quality once attained is also maintained, may jeopardize patient safety and contribute to a poor health outcome. Incorrect or misleading test results which initiate inappropriate treatment may cause more harm than no results at all.

Appropriate standards which support quality testing should be the desired approach, not minimum standards which provide the opportunity for quality failures.