Bias in Laboratory Medicine Standards

Inspired by a blog that I read, here is my contribution. A clinical laboratory standards group, CLSI writes laboratory standards which have been adopted by the FDA and hence these standards could be thought of as quasi regulatory standards.

CLSI standards attempt to provide a balanced view between industry, government, and hospital laboratories. The balance is provided by having approximately equal representatives from each of these three groups on committees that write standards and on the board of directors. However, in the area that I have been involved – the committee that writes statistical (Evaluation Protocol) standards – many industry members are not statisticians, from R&D, or from manufacturing – they are from regulatory affairs. Unfortunately, these regulatory affairs members often take an obstructionist role when standards are perceived as providing information that is not to their company’s liking. This is bias number 1.

An example is the standard EP11, which is about uniformity of claims and was canceled by the CLSI board of directors even though it had been approved by its committee. EP11 would have provided a consistent way for manufacturers to state performance claims. The obstructionists said it was no longer needed and superseded by other documents (which was false). An example of a poor claim is in EP7, the standard about interferences, which states that if a substance causes less than a 10% bias, it can be claimed that it doesn’t interfere. This is of course an incorrect statement and suppresses information. EP11 would have changed this.

Bias number 2 is that there is an industry trade group – AdvaMed – which can mobilize the industry members to influence standards. There are no such groups for hospitals or government. AdvaMed did mobilize to influence the demise of EP11.

Bias number 3 has to do with CLSI membership fees. Manufacturers pay up to 70 times more in fees than a hospital laboratory. With this much money, an unhappy manufacturer can influence standards by threatening to drop its membership.

So the balanced way of producing standards is not so balanced and dominated by industry.

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