Is Accreditation the only way?

Over my career I have had a bipolar relationship with medical laboratory accreditation bodies.  On the one side I see accreditation when it performs its functions as an external assessment body as an important and valued partner for laboratory Quality.  Being an outside set of eyes with both an understanding of Quality and laboratory practices and armed with an established standard such as ISO 15189:2012 or ISO/IEC17025:2005 or one of the related documents that has been adapted from the parent document and used on a local or regional basis, accreditation bodies can be powerful supporters of the laboratory Quality performance.

On the other side I have been particularly critical when accreditation bodies believe it is within their purview to write or cherry pick their own standards or when they allow for loose understanding and even looser interpretation by peer reviewers.  Any assessor who starts an accreditation observation with the phrase “Well in my laboratory we do it this way…” is a bad assessor should be terminated immediately.  I don’t care what someone does in their laboratory; I need to know if my laboratory is meeting the word and spirit of the established standard. 

And it irks me when folks who have never worked in a laboratory or have no recent understanding of laboratory activity believe they are appropriate persons to be take authority for creating standards. 

And I really fatigue of Accreditation Bodies that year over year a hundred percent success rate on laboratory accreditation.  While I don’t think it is nice that some laboratories are closed and people lose their jobs or hospitals or communities are inconvenienced, I find it far worse when weak laboratories are given admonitions, knowing full well that nothing is going to happen.  If a laboratory has a poor performance, it is far better than the inconvenient thing happen and the problems get addressed rather than wait for the horrific failure to occur. 

And what especially annoys me is the verbiage that says that Accreditation can assess the competence of a laboratory.  What total nonsense.  Accreditation visits are staged events, barely longer than a Broadway play.  The notion that a group of people can come into a laboratory on a given day and make anything other than superficial commentary on the activities of the people working on that day is a good example of a hallucinatory pipedream.

Recently I was in discussion with a person with responsibility and authority and commented that the olden days the technical requirements of a laboratory were both manual and working knowledge based.  Laboratory workers need a lot of hands-on skills and accurate recall of intricate data.  Today’s laboratory is different;  autoanalysers have taken over most of the manual and mental skills, leaving staff requiring a new skills focused mainly on computer and data handling.  In the olden days, laboratory workers needed to be able to manually maintain hardware and sometimes ripping it apart and then repairing it.  No longer.  Equipment these days needs service experts or more often, is just swapped out. 

Skill sets come in two categories, routine and crisis intervention.  Both work well the vast majority of time, with the rare and irregular slip and/or distraction that leads to error.  The reality is slips and distractions do not lend themselves to measurement for competence on a given day by a given group no matter how clever they are.  Most site visits will never occur on the day that an error happens.

What accreditation bodies look these days is evidence that Quality Control and the Quality System are intact and being followed faithfully The accreditation body is determining if the organization is meeting its laboratory-relevant Quality system in a manner than is likely to detect error early, remediate it and correct it before ensuing harm spreads beyond the confines of the laboratory.  Not to belabour the point, but we have groups that look at whether or not an organization’s Quality system is intact: we call them Certification Bodies.   

So while the accreditation bodies often view certification bodies as their inferior and evil twins, the reality is that by and large to two groups provide the same function.  And if that is the case, do we really need both?

From my personal perspective, I find that the Certification Body that visits CMPT on an annual basis, provides a demanding review of our Quality System and Quality Control.  They don’t have the time or experience or knowledge to sit and watch as we go through the tasks related to planning or creating or transporting our PT samples, no do they sit in as we go through the evaluation process.  They find and examine the secondary evidence that supports that we are doing our tasks well.  Our adoption and regular assessment to ISO 9001:2008 has made us very effective PT provider. 

At a certain point medical laboratories authorities may want to ask if assessment of Quality and Competence can only be done one way. 

ISO and its Neutrality Principle: just words?

The International Organization for Standardization knows and understands its role: through the development of standards through a steadfast commitment to consensus, the organization creates a voice of equality for all its member countries, and establishes a basis to promote non-barrier trade.  The organization is so committed to the concept that it framed its logo identification not as a mnemonic by as the Greek root ISO for “equal”.  Old stuff but worth repeating, in part because sometimes this commitment to equality is not always so apparent, unless excluding developing countries and regions is fully compatible with ISO equality.

But back to being more positive, recently an important committee known as  ISO CASCO circulated a new document entitled “Conformity Assessment for standards writers: Do’s and Don’t’s”.  Before I continue, a moment of explanation is in order.  When ISO committees write documents they fall into two main categories; the ones that provide information on best practices, methods, procedures, and the other ones that provide statements that can be understood as rules or expectations.  The first group are called informative documents, and the second are called normative documents. 

Meeting requirements in normative documents is known as being in conformance, and formally demonstrating that conformance is being met both to the word and spirit is called conformity assessment.  So ISO CASCO is the committee that oversees the rules of creating normative documents and oversees the rules for organizations that do conformity assessment.

In general there are two types of business organizations that do conformity assessment; one group calls itself Certification Bodies, and the other group calls itself Accreditation Bodies.  There are definitions that distinguish between these two groups (one group says that it measures not only compliance, but also competency and states that the group only measures compliance), but in my experience, when boots are on the ground, it is pretty difficult to see real differences between how the two actually do their assessments differently.  One group says that it perceives what it does is assures a higher level of quality, but from my perspective and experience that is pretty iffy.  

Most importantly for the present discussion, both AB’s and CB’s are represented on ISO CASCO which means they are both third party participants in standards application.  In order to be seen as not representing one group over the other, ISO CASCO has created its Neutrality Principle. It is very important to know and understand what the neutrality principle states and means.

The Do’s and Don’t’s document states: “The “neutrality principle” means that the content of the standard shall not state a preference for a form of one type of assessment over another.  In other words, the standard must be written so it can be applied by any of the following: - (a) a manufacturer or supplier (b) a user of purchaser or user and (c) an independent [third] party. “  This is very clear.  It says that a standard has to be written in a way that its application is seen to be neutral for all and exclusionary to none, on the assumption that the assessment is done competently.      

What this says to the laboratory community is that a document like ISO 15189 can be adopted by any laboratory, and that laboratory user can assess whether or not it is adopting the rules in the documents.  This is separate from the process of accreditation.  If you believe in Quality you can apply the document.  If you believe that external assessment improves the degree of compliance, then you can invite an independent third party to made an assessment over and above adoption.  

This is very important to understand, especially for small laboratories in countries that do not legislate accreditation because it reinforces the point that a laboratory can (and I think should) adopt 15189 at its own pace, and when it is ready make the second decision based on finances and commitment and business advantage as to whether it sees advantage in having a competent third party do an independent assessment about the degree of compliance.  

But here is my concern; the third iteration of ISO 15189 is about to have its final vote before formal adoption, but it contains the sentence “This international standard is not intended to be used as the basis for certification of laboratories”.  

So exactly how does that mesh with the words and the spirit of  ISO CASCO neutrality principle?  

Words or rhetoric?