CLSI eNews - 5 May 2005  (Plain Text Version)

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 Terminology Focus
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Volunteer Focus

Consultants Sheila Woodcock and Jan Krouwer

Sheila A. Woodcock, ART, MBA, is Chairholder for the Clinical and Laboratory Standards Institute (CLSI) Area Committee on General Laboratory Practices, and serves on the Volunteer Resources Committee.  Principal Consultant with QSE Consulting, Ms. Woodcock has worked in health care, education, professional regulation, and consulting, both in her native Canada and on the international level. 

You conduct operational reviews for everything from teaching hospitals to blood processing facilities to water treatment laboratories.  What do you see as being the consistently translatable principles of quality management both within and outside the healthcare field?
I guess the trend is that everyone is moving towards the implementation of quality management systems, and that’s changed over the last ten years.  It wasn’t the case ten years ago; it was something that only a few were looking at.  In the U.S. especially, there was a lot of skepticism around it; but now, everybody’s recognizing that this is the way to go.  And it will improve their operations overall.

What do you think has been effecting that broad change in opinion about quality management systems:  the skepticism, then the implementation?
Well, I think it’s a combination of factors.  Obviously, the ISO (International Organization for Standardization) process has played a part in it, but I think that CLSI’s role as the secretariat for ISO did two things: it profiled (quality management systems), because there was information going out in the newsletters... so people suddenly became aware of the fact that ISO was not something just for industry; secondly, it gave the ISO process more credibility in the eyes of the U.S.

As Chairholder of the General Laboratory Practices area committee, what pressing or contemporary issues do you think need to be addressed?
I think one of the challenges that our committee is facing right now is determining what documents are needed to complement the ISO standards as they emerge.

In addition to your work on the GLP area committee, you’re involved in the Volunteer Resources Committee and the Working Group on Technical Procedural Manuals.  What drew you to devote your time to these committees?
Well, the Volunteer Resources Committee is very important; the volunteers are the key to CLSI’s success, so how they perceive the organization, how the organization treats them, supports them, all of those things, are critical. I saw that as being an important role, and I felt very honored when John Bergen (former Executive Vice President of CLSI) asked me if I would participate in that committee.

What initiated your involvement in CLSI?
I guess what initiated it was the start of the work on the first GP26 (Application of a Quality Management System Model for Laboratory Services) back in 1996.  At that time I had been interested for a number of years in quality, and quality issues—anything related to quality.  When I saw the call for volunteers for the development of a quality system for the lab, it caught my attention.  So that was my first venture into the world of CLSI.

And what do you think has changed in the intervening years?
Well, the big thing that’s changed is that, when I went to my first meeting, they were quite excited to have someone from Canada, and I was sort of the global representative.  And that has changed a great deal in the intervening years.  I’m very happy to see a lot of representation from other countries.

Tell me a bit about the work you do with QSE Consulting.
Well, it ties right in with my role in CLSI in that the work that we do is helping labs implement quality systems, improve processes, increase efficiency. “QSE” stands for Quality Standards and Education.

And in Lebanon, you were working with resource-limited laboratories there?
That one was a little bit different; that was working through the Michener Institute in Toronto.  It’s a postsecondary education facility that’s unique in that it only provides education for allied health professions.  They do work overseas, and the funding comes from the Canadian government.  This particular project was to provide education for the Palestinian refugees in Lebanon.

From that experience—your experience in general—what do you see as being CLSI’s role?
I think that CLSI has standards which are applicable in all labs, and that particularly now, there is a diligence in the “in-development” documents to make sure they’re not U.S.-specific; when they are, they’re flagged as such, and I think that’s a really progressive step. 

What are you pursuing at the moment?
At the moment, I've just completed an article on Quality Systems Software for the June Issue of ASCP's Laboratory Medicine, and I’m talking to you right now from the west coast in British Columbia, where I'm working with the provincial government to help all of the hospital labs implement quality systems. 

So, whether you’re presenting or pursuing your daily work, your job is to educate.
Yes!  I’m going to be doing the same thing starting very soon on the east coast, in Halifax (Nova Scotia, Canada).

Tell me about the role CLSI documents play in the work that you do.
They’re very important, because, for example, we have a workshop coming up that Luci Berte (MA, MT(ASCP), SBB, of LMB Consulting in Colorado) is coming to do in BC (British Columbia)—a transfusion medicine group that’s starting out on implementation of quality standards. Luci’s doing a workshop, so we purchased a whole set of five documents each in the quality series, for each of the 12 participants coming to the workshop.  So that was a big order!  Everywhere I go, I talk—talk to people about the quality series documents, particularly because they are the ones that fit closest to what I do.  But I always encourage people to look at the guidelines that CLSI has, because there’s usually one that fits whatever their need might be.  

And what future steps would you like to see?
Well, the documents are applicable everywhere; more people need to know about them.  And we’re getting more and more people from other countries involved in (document) development. It is people like us, the volunteers, that do a lot of the promotions, spreading the word about CLSI and the importance of the standards.  So the more people we get involved, the more the word’s going to travel.  But there are two groups (of CLSI standards and guidelines); there are the existing documents, and the new documents, the leading edge.  But then there are the old documents, the ones that are out of date.  They’re of no interest to anyone in developed countries, but there is a place for them in some of the developing countries.  And they’re of interest to volunteers like Dr. Tom Hearn from CDC, who does a lot of work in developing countries; (there are also) situations like the Lebanon one where we were, where there’s an opportunity to distribute those documents.  So I’m excited about the opportunity for CLSI to play a philanthropic role.

Sheila Woodcock is presenting at the CSMLS/NBSMLT Joint Congress of Medical Laboratory Science on 28 and 29 May 2005 at the Hotel Delta Beausejour in Moncton, New Brunswick, Canada, where she will be discussing CLSI Quality documents HS1 (A Quality Management System Model for Health Care), GP26 (Application of a Quality Management System Model for Laboratory Services), GP22 (Continuous Quality Improvement:  Integrating Five Key Quality System Components), GP2 (Clinical Laboratory Technical Procedure Manuals), and GP21 (Training and Competence Assessment).  For more information, visit http://www.csmls.org/english/nb-congress/congress2005.htm.

Jan Krouwer, PhD, has been a Clinical and Laboratory Standards Institute volunteer since 1983, and is currently involved in the development of the EP22 document, the “Option 4” proposal for a new, alternative quality control procedure.  Former Chairholder of the Evaluation Protocols area committee, Dr. Krouwer developed companion software to be used for CLSI document EP21, Estimation of Total Analytical Error for Clinical Laboratory Methods, for implementing the protocols for judgement of the clinical acceptability of new methods using patient specimens and/or monitoring an assay's total analytical error by using quality control samples.  A long-time employee of Bayer Diagnostics, and similar companies, Dr. Krouwer founded an independent consulting firm in 2001.  Krouwer Consulting serves clients in reliability and statistics for medical diagnostics, biotechnology, and hospital error rate reduction. 

What initiated your involvement in CLSI?
I started when I was back at Technicon over 20 years ago.  It was something my supervisor (Stan Bauer) recommended.  I was a volunteer and worked on subcommittees.

Tell me about Krouwer Consulting.
I try to help companies and hospitals with quality-related problems; especially in terms of reliability issues that they might have using techniques such as fault trees or reliability growth management.

And before that you worked at Bayer as an internal consultant?
Yes, I set up a statistical consulting group.  We had about 20 people working on clinical trials, reliability improvement, and stuff like that.

What do you have coming up?
Through the Northeast Section of the AACC*, I’m doing an hour-long presentation about reducing medical errors in labs by using Failure Mode and Effect Analysis (FMEA).  And at the AACC 2005 Annual Meeting in Orlando (this July), I’m discussing the same topic; just a little bit expanded in length.

And what CLSI documents are you going to be discussing at these presentations?
GP26 (Application of a Quality Management System Model for Laboratory Services) and maybe HS1 (A Quality Management System Model for Health Care)—the FMEA technique requires that you try to come up with causes for potential errors, and one of the methods that I use is something called fault trees, which is something like a cause and effect diagram, or a fishbone diagram. 

How do they tie in with your presentations?
The fishbone diagram is a way of trying to come up with error causes by starting with the top-level problem and hierarchically trying to find causes for the top-level problem and then the one below it, and so forth.  Things like the quality system essentials in GP26 are usually not part of a process map upon which a fault tree is based, but it could be.  So it’s useful as a supplement; as a potential list of causes for errors, things that might go wrong with quality system essentials. HS1 is the same thing, for general healthcare organizations, rather than labs.

I understand you’re on the committee for the new EP22 project (the Option 4 proposal) as an advisor.  Any plans for that?  Goals?  Anything in particular you would like to see happen?
Well, this is what I do, since the document is about risk management.  That’s something I’m interested in.  I’m interested in how it develops, since I’m someone who’s written software about how to do this stuff.  I want to see how the subcommittee approaches it.  It’s also connected with this Option 4, which is to reduce lab QC.  It’s something I want to see develop.

*Dr. Krouwer is presenting on behalf of the Northeast Section of the AACC on 19 May 2005 at the Doubletree Hotel in Waltham, Massachusetts, USA.  For more information, visit http://aacc.org/divisions/northeast/default.stm.

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