Leadership Conference Highlights Globalization Goals, Challenges
US and non-US members agree that partnership -- not stewardship -- is at the core of CLSI's global identity

The 2005 Clinical and Laboratory Standards Institute (CLSI) Leadership Conference marked a series of firsts:  It was the first Leadership Conference under the organization's new name, and the first to include a workshop focusing on an issue concerning all three sectors of the CLSI constituency.  It was also the first Leadership Conference for new CLSI Executive Vice President Glen Fine, as he succeeded John Bergen’s 23-year tenure at the helm of the Executive Offices’ staff, announcing to volunteers,

“This is my first experience leading a volunteer organization such as CLSI, and I am thoroughly enjoying the experience.”

In Fine’s first public address to CLSI volunteers at the Volunteer Appreciation Luncheon on 17 March 2005, the former MDS Laboratories Vice President set a tone of humility, curiosity, and optimism for the conference, and for the new era of leadership for the Executive Offices’ staff.

“You, the people in this room, are CLSI.  You elect a board representative of your collective interests, the board sets and carries out your will, and the staff execute on this collective will.  You do it for reasons of altruism, networking, reputation, learning, and growth.  We must never forget that I and the rest of the Executive Offices’ paid staff work for you.”

The first conference under the new organizational name of Clinical and Laboratory Standards Institute, the March event also became an opportunity for members and volunteers to acquaint themselves with the new name, and its meaning.  The presence of volunteer organizations from across the healthcare disciplines highlighted the broadened scope of work the new identity represents, both inside and outside the clinical laboratory.  However, for many attendees, it was the globalization initiatives marked by removal of the word “national” from the organization’s title that made the first CLSI Leadership Conference a truly landmark event.

For Morichika Tanemura, President of the Japanese Committee for Clinical Laboratory Standards (JCCLS), the conference fell in line with a “nationwide initiative” underway in Japan for clinical laboratory testing standardization.  While Tanemura came to Baltimore to represent JCCLS — a partner organization of CLSI — in a presentation to the Board of Directors and at other meetings, Tanemura found the “Emerging Trends and Opportunities” plenary session of the Leadership Conference to be particularly valuable in light of current Japanese goals. 

“Without adaptability, any standardized scheme could easily become obsolete,” Tanemura says.  “Therefore, JCCLS must be committed to putting into place a system that will accommodate in a timely manner any innovative methods or technologies developed in the future.”  At the Leadership Conference, Tanemura says, he was “made aware of the need be able to incorporate new or innovative technologies into the model JCCLS is currently devising.”

Like Tanemura, Belfast’s Professor Ian Young, of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), spoke at the Board of Directors session, and also attended the Global Programs Committee meeting.  Participating in the CLSI event as a representative of an international organization concerned with laboratory and methods standardization, first-time attendee Young says he was particularly attentive to the “international perspective” of CLSI.

“I was very interested in how CLSI perceived itself as a global organization and how it intended to develop in that area,” Young states.  “What came across to me very strongly was that CLSI wishes to be a major global organization in terms of setting laboratory standards.”  Young says he was “very impressed” with CLSI’s commitment to developing the care of patients in all countries. “That came across to me as a very strong commitment on the part of CLSI, in which I was very interested.”

However, while Young feels that the globalizing efforts of CLSI are in earnest, he concedes that the organization faces challenges imposed by factors outside the laboratory community, as broad and enculturated as the classic “ugly American” archetype, and as specific and timely as America’s war with Iraq.  

“Obviously, while not wishing to be political, (global harmonization issues) can be caught up in the wider perception of America internationally.  At the moment, there is a certain amount of international hostility towards what’s seen as American expansionism.”  While Young says that he does not think current international tensions are a “major issue” in the European laboratory, he asserts that the tenuous global climate is one reason why “it’s very important to ensure that there’s a close and a complementary relationship between, for instance, IFCC and CLSI, and that somehow a way can be found for the two organizations to work together.”

Young stresses the importance of IFCC and CLSI continuing to develop their close working relationship, and ensuring that they’re complementing rather than competing with each other in the work they do:  “The commitment to partnership with IFCC came across to me as a very strong commitment on the part of CLSI.  The relationship between the two organizations has developed well over the last few years, and I think there’s commitment on both sides to work very closely together in the future.”

Patrick St. Louis, PhD, DipCC, of the Department of Clinical Biochemistry at Hôpital Sainte-Justine in Montreal, says that, while he feels that CLSI’s global initiatives are steps in the right direction, Canada, as an international member, is scarcely affected due to its already longstanding involvement with the organization.  “We, your neighbors north of the border, have always been very attentive to CLSI, and a lot of our institutions participate and are members at different levels.  We have always seen the advantages of the organization.  There has been a considerable amount of integration of Canadian people into (CLSI) over the years on pretty much every level.  So, from our point of view, I’m not sure that deep inside (current globalizing efforts) make much of a difference to us in Canada vis-a-vis our perception and direction with the organization.  There has not been much of a ‘them and us’ when it comes to Canadian perspectives on the organization.  I think we feel we’re already reasonably there.” 

Maria Carballo, Therapeutics Products Director at the Medical Devices Bureau of Health Canada, says that Canada represents a “middle ground” between the US and European regulations, business practices, and terminology.  “We often have the opportunity to look at the Europeans and the US and say, ‘We like what the Europeans are doing here, and we like what the US is doing there.’  The regulations here tend to be similar to the European regulations, but we do deal with a lot of manufacturers in the US.  So we tend to be somewhere in between Europe and the US.  The objective of harmonization is to minimize that difference.”

While Carballo says that the change to a more inclusive name is a “fantastic idea,” many challenges lie ahead in harmonizing to ensure global inclusiveness on all levels.  “There’s a lot of good work that needs to be taken to the next step.  I like CLSI taking a lead role in having global representation, and not only from Canada.”

Carballo is a new Board member, installed at the 17 March 2005 Volunteer Luncheon.  While participating on ISO/TC 212, her global perspective led to an invitation to serve on the Global Programs Committee.  She says it was her particular interest and involvement in global concerns that led to her election to the Board.

“I know of course that the US market is a main priority.  With (CLSI’s) involvement in CLIA being a major issue, I saw that at the workshop.”  However, Carballo says, the Quality Control concerns discussed at the workshop are bound to reverberate in regulatory agencies across the globe, and she saw the meeting as not only a view to what is around the corner for the global medical industry, but also an opportunity to find common ground and initiate international teamwork.  “We should be able to find solutions together – Canada and the US, and people everywhere,”  she says. Carballo notes that, regardless of nationality, CLSI members share a basic interest in the organization’s founding goal of improving health care worldwide:  “That’s what we all want in the end.” 

  [ return to top ]