Volunteer Focus
CLSI as Curriculum: Michael A. Noble, MD, FRCP(C) of the University of British Columbia

Recognized international expert on laboratory proficiency testing (EQA), laboratory standards, and laboratory safety, Michael A. Noble, MD, FRCP(C) brings CLSI documents to the curriculum of the University of British Columbia, where he is medical microbiologist at the affiliated Vancouver Hospital.  Noble, also Chair of the Clinical Microbiology Proficiency Testing Program (CMPT) at UBC, launched the online UBC Certificate Course in Laboratory Quality Management in 2004—with a syllabus entirely comprised of CLSI and ISO documents.  Now, with students from eight time zones converging in a lively online classroom, registries already coming in for January 2006, and a groundswell of teaching interest from his colleagues in the quality arena, Noble says the course has tapped into an immediate and growing demand for consistent quality management expertise that spans national borders.

Why is it important that these documents are on this course's syllabus?
In the last few years, North American laboratories have been realizing that quality management processes that have been integrated into industry for years—if not decades—were missing from medical laboratories.  A number of options have become available, and those include ISO 9000, ISO 15189, and (CLSI documents) HS1 and GP26.  At the University of British Columbia we've recognized that people who want to become quality managers for medical laboratories need to have training, and we’ve created an online course for their certification.  And so, once we had decided to do that, it became clear and obvious that we had to provide those people taking the course with a lot of access to all four documents. 

So this course is geared towards people who are already in the quality management profession? Or is it designed for undergraduates?
When we started, we thought of it as being an undergraduate course.  And then we realized that was silly,  because you can’t talk about being a quality manager until you know what a laboratory is.  And so we have a minimum requirement of five years of work experience before they can take the course. 

Who's taking it?
To date, 50 people have gone through the course:  pathologists, laboratory scientists, laboratory technologists; some with prior management experience, some without prior management experience; and at least from the first group, all of them have found positions as quality managers in the laboratory. 

Geographically?
We have people taking our course from Guangdong Province (China), from Saudi, from Dallas, from every Canadian province, so it's a little easier that it's strictly a Web-based course.

And why, in your opinion, is it important to have that kind of geographic, demographic diversity in learning about quality management? 
Medical laboratories are entering the international era.  Your patients are likely to have come from somewhere else; your staff are likely to have come from somewhere else; the management of your laboratory may be from somewhere else; and the reality is that very narrowly created guidelines and standards from a single domestic region have a lot less applicability today than they did 20 years ago.  And CLSI recognizes that, ISO recognizes it.  So we are taking international documents and we are presenting them to an international audience, and the international audience is appreciating it.  

How have they expressed this?
I will tell you that students from Guangdong are very interested.  They have recognized that the way to avoid the laboratory problems that SARS created is through adoption of recognized international documents to establish the processes of quality management within their laboratories.  And I agree with them:  that’s the way that we prevent bad errors from occurring.

Tell me about the course requirements.
It’s a 20-week online course.  Assignments, discussions, examinations, and certification—UBC certificate at the end for those who are successful.  It’s run asynchronously, because we’ve got people over eight time zones taking it. 

How does discussion among peers and with teachers work?
We use an underlying course management program, which allows for chat rooms, discussions, Power-Point, white boards. There are student-driven discussion groups with faculty direction or input. 

How will the curriculum develop?
We’re going to be expanding the use of the ISO 15189 family of documents as well.  And as additional appropriate documents come out of CLSI, we will be incorporating those as well.  That’s not to say that there aren’t other ones that are also appropriate; but it is a 20-week course, so we have to be selective as to the information that we cover.

Any others showing interest in putting them on syllabi elsewhere?
If courses purport to train people in quality management, and want to highlight where medical laboratories fit into this scheme, and they don’t use HS1 and GP26, then they probably have a deficiency in their course.  I can’t imagine having a course without them. 

Tell me about your career path. 
I'm a medical microbiologist by training, with specialties in both internal medicine and then medical microbiology.  I did my undergraduate at University of Western Ontario, my residency training in Toronto, and then went to Halifax, to Dalhousie University.  My first entry into quality management issues for medical laboratories was when I got to Vancouver in 1983, and had the opportunity to run the clinical microbiology proficiency testing program.   And, from that, I became involved in NCCLS (now CLSI), through which I became involved in Standards Council of Canada.  When the International Organization for Standards Technical Committee 212 (ISO/TC 212) was formed in 1995, I became the chair of an advisory committee to that group, and a member of ISO/TC 212 Working Group 1--the committee that wrote ISO 15189. 

What were your impressions of this last meeting in Washington, D.C.?
(TC) 212 is maturing well.  I think there are a number of initiatives that have come along that are very important--the point-of-care document soon to be completed will be very valuable.  There are two steps that are going forward that I think will be very important--the upcoming renewal of 15189, and the venture going forward between Working Group 3 and Working Group 1, which has to do with the introduction of the concepts of risk management as an essential part of quality management for the medical laboratories.  I know CLSI is very interested in this topic, as is ISO.

How did you arrive at this role of educating people on laboratory quality management?
From my interests in 15189, NCCLS morphing into CLSI, external quality assessment through proficiency testing, it became obvious to me that medical laboratories were going to require quality managers in order to move forward.

What does your day-to-day work consist of now?
Well, I'm still paid to be a medical microbiologist with Vancouver Hospital.  My university activities involve teaching and the running of our proficiency testing program--the only ISO-certified proficiency-testing program in North America.  And our quality mission involves four statements:  Innovation, meaning research and development; Education; External Quality Assessment; and Continual Improvement.  So I am not only the Chair of CMPT; I also am the Quality Manager for CMPT.  And we spend a lot of time actively living the quality management program for CMPT.

What else do you have going on, now or in the future?
There is a Cumitech document—Cumitech is a series of small books written by the American Society for Microbiology—and this one was just published this week, Cumitech 3B—called Quality Systems in the Clinical Microbiology Laboratory.  And I believe it highlights a number of things, including CLSI documents.  I’m one of the authors of it.  There’s another thing which is called the Institute of Quality in Laboratory Medicine, which was initially developed by the Centers for Disease Control and Prevention (CDC)—I was involved in that.  And every year, we put on a quality workshop at the Canadian Association for Clinical Microbiology and Infectious Diseases (CACMID), and that meeting will be in Victoria in March of 2006.

When do courses begin, and how can people find out more, or sign up?
The course starts every year in the second week of January, and those people interested in finding out more about the course for 2006—and we already have people enrolled in it—can get in touch with me directly if they’re interested in finding out about the course.   

For more information on the UBC Certificate Course in Laboratory Quality Management, contact Dr. Michael A. Noble at mnoble@interchange.ubc.ca, or jwourerse@pathology.ubc.ca, or visit http://www.interchg.ubc.ca/cmpt/. 

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