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Sunday, May 18, 2014

Standards Development in the crosshairs.



Standards Development in the crosshairs.

There is a revolution afloat in international standards development.  Without knowing all the details yet, the  International Organization for Standardization (ISO) is creating new requirements that include new format rules and perhaps more importantly new justification rules.  I suspect the organization is feeling some concerns about some sector and subject specific documents that each introduce some subtle variation from the parent document.  Whether or not my assumption is correct, from my perspective, this is a dangerous road for the organization to travel.  It could well end up with some unintended consequences.  

So far I am aware of two examples where the process has resulted in a rejection of approval to update an existing standard. One example is the standard for what the medical laboratory community calls Point of Care Testing.  This is the performance of a laboratory test, sometimes by a laboratory trained person, often not, outside of the traditional laboratory environment.  This is possible, primarily as a result of innovation and inspiration by researchers and reagent producers.  These kits in many respects have been created to be almost idiot proof, the key and operative word being ALMOST.  The results of POCT tests are still vulnerable if the sample is collected improperly or insufficiently, or if the kit is out of date or stored or used improperly.   Folks need to know and understand this because clinicians, and especially patients, expect to get accurate and reliable  information regardless of who did the test and where it is performed.  And the standard that was developed was used as a foundation document to help people learn and introduce the necessary precautions.  

Without going too far into the details, when the technical committee set out to update the document, ISO, applying the new rules first halted the process and then caused it to cease, as is their right,

But if the document is not updated, the existing document now obsolete and incomplete may continue to be used.  That serves nobody’s purpose, and that includes ISO.

In the past I have talked about the intricate dance between Quality Partners [see: http://www.medicallaboratoryquality.com/2011/06/more-musings-on-quality-partners.html] which are the organizations that work together to enhance and ensure Quality improvement.

First off, to be clear, just because a company puts the word “standard” in their name, does not mean that their documents are recognized and used as standards.  Authoritative and informative documents can equally be written by national or provincial or regional organizations.  In many jurisdictions, an accreditation body has the right and authority to consider a number of documents and decide which one makes the most sense in their domain.   In jurisdictions where there is no accreditation body, local groups can convene and make their own local decisions.  More importantly, in situations of litigation, the courts can deem any public document as a standard of practice, including information written as a “Letter to the Editor” in what the court considers a journal of record.  

The bottom line is that organizations including bodies like ISO have competition, and more importantly can be subject to the good will of their document writers, all of whom are volunteers, many of whom are putting their own time and money on the table.  The reality is that while ISO personnel are managers of their document structure and format and style, they are totally dependent on those volunteers for the true essence of the documents, the subject content.

When organizations change the rules, countries can choose to no longer send delegates, and volunteers can choose to no longer expend their effort and expertise and slowly and quietly the documents starts to diminish and their appeal starts to decline.  

The truth is that many folks are already feeling a certain degree of ISO fatigue.  Meetings are expensive to attend and cost a bomb to put on.  ISO puts nothing in to process other than their name and expects that participants to put up with their whims and vagaries.  This is not a formula that leads engenders a lot of lasting support.

Dangerous game they are playing.

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