Patient Safety and Healthcare Quality

Dear Lezlee,

Thank you much for these links, especially the link from WHO. 

Working at the international level with low and middle income countries (LMIC), I am currently seeking guidance to assist individual sites in their support of the WHO HIV-1 RNA algorithm for ART management by translating the performance goals into analytical goals for the laboratory. 

As microbiology procedures migrate into the quantitative assay arena through molecular methods, assessing statistical patterns against acceptable tolerance limits becomes a must to assure accurate results for patient management beginning with initial verification and continued with long-term monitoring.

To date, I have not been able to locate validation studies that targeted the performance quality goals needed to fulfill the WHO HIV-1 Viral Load Algorithm (1000 copies/ml cut-off, 0.5 log copies/ml difference in successive VL measurements) in the clinical laboratory.  Since WHO defined the quality required for effective clinical decision making, would this not have been the better quality goal, as prescribed by the Milan Hierarchy, to use to compare the error produced during validation experiments and confirmed at the site with verification? Without allowable goals based on analytical performance related to clinical outcomes,  defined for either measurement of uncertainty or total allowable error (TE<TEa), how can the laboratory promote patient safety? 
Even though the laboratory director is held responsible for approving quality goals, is it feasible for them to do this without some data-driven guidance from the molecular community?
If we continue to practice arbitrary control instead of quality control, the risk to patient safety will not be reduced in our profession.  Erroneous results produced by the laboratory are clinically misleading, at best, but also

quickly can become catastrophic as the NEVER AGAIN video described.