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Wednesday, May 22, 2013

The Fun Side of Standards Development.



The Fun Side of Standards Development.

Today I am at a semi-annual meeting of our Working Group for development of ISO standards.  I am in London at the British Standards Institute’s Chiswick Building.  I am sure that some (maybe many) see this as a scam to get to travel around the world while using other people’s money (OPM).  [As an aside I have always thought that it is not by coincidence that the two most powerful addictions in the world are spending OPM (in the sense of money) and consuming OPiuM (the drug)].  I will also tell you that while it is true that ISO standards meetings are held around the world, in most resource wealthy countries, governments most often provide financial assistance for about 25 percent or less of costs.  Many governments provide no support at all.  The rest often comes from delegates’ employers who may recognize some corporate advantage in participating in standards development.   A large chunk comes from personal resources.  

People interested in the process of standards development are similar to athletes at the national level; they do what they do because they are driven by personal satisfaction and personal passion and ambition. There is something satisfying in being involved in the development of  documents that are likely to be used around the world.  For me, I am not particularly driven by altruism; I also enjoy the travel and meeting with like-minded people, and I also  find standards development personally intellectually stimulating and challenging.  

There are all sorts of hobbies in which adults can get engaged.  For some it is buying art or cars or bicycles or boats, for others it is travel or sports or collecting stamps; for me it is getting into the nitty-gritty of creating documents that I know will be used around the world, and I am prepared to use some of my own resources, to some extent, to get the opportunity to be engaged in the process.  But I would not recommend this as a plan for folks on a fixed income.  

I will say that being engaged in standards development is not purely an intellectual exercise; in some regards it is a self-preservation exercise.  I spend a lot of time involved providing proficiency testing materials and education for medical laboratories.  PT is driven by requirements and expectations that are largely driven by standards that focus on quality performance.  Our program is driven by these standards.  If I am going to be expected to live by these standards, they by gosh I want to make sure that they are written in a way that I can live with.  If I choose to ignore standards development I may be stuck with requirements that I don’t agree with and don’t work with my vision of the activities with which I am engaged.  

I will give you an example.  In one of the drafts of a document being written now there was a phrase that said that laboratories should not allow financial or political considerations impact decisions on laboratory performance and test selection.  It was inserted by a delegation from a large country with a strong socialist political bent.  Their belief is that entrepreneurial activity in the laboratory arena leads to unethical practices at the expense of the poor and sick and public coffers.  

Well that sounds nice but in my world that is an unreasonable expectation.  My employer is clearly not-for-profit, but at the same time makes it really clear that it certainly is not-for-loss.  If my program offers surveys and challenges or courses that cost money to develop without a chance of recouping expenses, then my program will not last for very long.  Every decision that I make has to include financial consideration.     

I, and other like-minded folks could not let a toss-away phrase about being indifferent to financial considerations, no matter how well intentioned end up in a standard which could impact on my operation, and we were pretty vigorous at making the point that the phrase had to be removed.  

So for me standards development is a perfect activity; it is intellectually stimulating, and involves meeting and discussing and debating with similarly involved people with a full range of opinions.  I get to assert my knowledge and opinions and get to influence documents that can have local, and national and international impact, and I get to travel and see the world or sometimes invite the world to Canada. 

All things being equal it is a very good activity.  

PS:   Registration for the POLQM Quality Management Conference for Medical Laboratories is now open.  Visit our web-site (and click on the link for the conference announcement now to get registered.  
Attendance will be limited, so register early.



Saturday, May 18, 2013

ASM Quality Workshop



ASM Quality Workshop
Today we participated in the Quality Workshop at the Annual General Meeting (ASM) for the American Society for Microbiology.  In some respects this is the perfect union.  The ASM attracts about a bazillion people from around the world.  It is big enough to fill almost every hotel in Denver.  The Quality Workshop is a bit of a niche interest, but we managed to have people from across the US, Canada Lebanon, South Africa, Australia and the Republic of Cameroon.  Small conferences will attract interested folks, and mega-meetings will attract broad international crowds.  We were lucky to end up with the best of both.

Without wanting to overstate the situation, I think the light has gone on  in the United States.  While at one time the CLIA regulations were the vanguard leaders in the world, many would say at 25 years old, CLIA has become a tired millstone in serious need of revision.  While there are many US laboratories that don’t give a damn to quality, those that are recognize that being accredited to CLIA provides no evidence of interest in making their laboratory better.  

Fast, cheap, east, mandatory and sufficient; good-enough is good-enough.

The folks that attended the workshop were of a different mindset; interested in learning about international quality, with higher aspirations for their laboratory’s reputation and recognition.

The meeting was put together by CDC and included two CDC speakers, a well-informed speaker from another laboratory and me.  One can find the names of the other speakers by going to the ASM Annual General Meeting site and looking for speakers at workshop WS:04.

It was an excellent meeting full of practical tips, and perspective. 

I gave a good overview of why Quality Management belongs in every laboratory. 
 A very good presentation was given on CLSI and that organization’s participation in the Quality area.  A very good crosswalk was presented on how CLSI guidelines lined up with the requirements of ISO standards.  It was pretty clear that CLSI is contributing to US medical laboratories by providing a series of documents that help implement Quality.   

What was really interesting to me was the presentation on measurement uncertainty from a laboratory in the US that had decided to get accredited to ISO/IEC 17025 very early on, had has had to struggle with MU.  A model for application of MU for quantitation of urine cultures was presented.  

I thought it truly excellent.  We all agreed that MU is an irrelevant waste of time, but has to be dealt with if a laboratory wants to benefit from the achievement of ISO accreditation.  Having to jump through hoops purely to satisfy accreditation bodies may be stupid and evil, but it unfortunately an unavoidable stupid evil.    What Alice presented was a model that would get it done in as painless a manner possible.  And that probably is the best way forward.  

And more to the point, the information is generated solely for internal  holding.  Do not present the information to anyone, other than the accrediting body. 
What I thought amusing was her mentioning that the accrediting body required her to actually to through the arithmetic during their site visit.  Just sad.

The last presentation was unfortunately cut short because so many questions were being asked.  It was too bad because it was shaping up as an excellent presentation fo some practical tips on implementing Quality on an voluntary level.  As mentioned, it your laboratory is not going to go for full ISO accreditation, you are still better off implementing some easy steps along the way, and gradually building your Quality inventory.  It is not the best way to implement Quality but if management and staff are committed, it can work.  I am thinking of inviting her to give the presentation again in Vancouver at the POLQM Medical Laboratory Quality Conference Meeting October 16-17-18 2013.

If you want to meeting an impressive faculty, plan to come to the meeting.  If you want to learn and discuss and debate Quality with peers, plan to come to the meeting.  It you want to participate in a World Standards Day celebration, plan to come to the meeting.

More info VERY SOON.

M

Sunday, May 5, 2013

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.