[Photo is Cape Cod Canal] Ok, the title was a rhetorical question. Some examples of the changes:
Blood lead lowest allowable limit:
1991 10 ug/dL
2012 5 ug/dL
2003 ISO 15197 standard is 20% above 75,
2013 ISO 15197 standard is 15% above 100,
2014 proposed FDA standard is 10% above 70.
Industry – Regulatory affairs professionals participate in standards committees and support each other through their trade organization, AdvaMed. The default position of industry is no standards – when standards are inevitable, their position is to make the standard as least burdensome as possible to industry.
Lab – Clinical chemists and pathologists are knowledgeable about assay performance. ALERT – pathologists are not clinicians. Also, lab people are often beholden to industry since clinical trials are paid by industry, conducted in hospitals by clinical chemists or pathologists.
Clinicians – Sometime, clinicians are part of standards but less often than one might think.
Regulators – People from FDA, CDC, and other organizations have to decide to approve or reject assays and are often part of standards groups.
Patients – Patients have a voice sometimes – diabetes is an example.
Medical Knowledge – As the title implies, the medical knowledge related to performance goals is probably of little consequence. For example, the harm of lead exposure is not a recent discovery.
Technology – Improving assay performance due to technical improvements probably does play a role in standards. All of a sudden the performance standard is tighter and coincidently, assay performance has improved.
Cost – Healthcare is rationed in most countries so cost is always an issue, but it is rarely discussed.
Note that the earliest standard for these two assays is 100% or more lenient than the current standard.