MANY OF YOU HAVE HEARD ABOUT THE WIDELY-PUBLICIZED PROBLEMS with laboratory testing in several locations across Canada in the past few years. We update the situation with a fascinating intelligence briefing on pages 9-12.

The first lab scandal to catch the public's attention was the discovery that, between 1997 and 2005, an anatomic pathology laboratory in St. John's, Newfoundland, had gone seriously off course with its estrogen receptor (ER) and progresterone receptor (PR) testing program. Subsequent reviews determined that at least 396 breast cancer patients got inaccurate results. Just last month, four years after these problems were identified, the parent health system announced it had "discovered" another 43 breast cancer patients who should have had their lab tests reviewed, but were missed by the review team. So even at the provincial health level, there were failures to accurately audit and identify all breast cancer patients tested during the 1997-2005 period.

However, what fascinates me is the second chapter in this story. In the wake of the public disclosures about ER/PR testing failures in Newfoundland and Labrador, several other provincial health systems in Canada did reviews of pathologists practicing within their region. In three hospitals in three provinces, these reviews uncovered serious failures in anatomic pathology test accuracy and reliability. As you will read, in at least two cases, it was the hospital's head of pathologywhowas determined to have done deficientwork, reaching back at least two or more years! One pathologist had an error rate of about 5% in the initial review of past cases. Another's error rate was 6%.

Critics are quick to point out that, in Canada, laboratory accreditation, certification, and proficiency testing is a matter left to the provinces. One consequence of this arrangement is that Canada lacks national laboratory quality standards. However, I have a more fundamental question: has reduced funding for anatomic pathology services contributed to these serious breaches in laboratory test integrity across multiple hospitals and laboratories?

Could it be that salaries are inadequate to attract and retain competent pathologists in some Canadian provinces? Has the health system cut back on pathology training slots in medical schools as a way to save money in the short term, while negatively affecting patient care in the long term? My hunch is that 30 years of serious cost reductions to lab testing services across Canada may have finally reached the point where inadequate financial resources devoted to lab testing contributes to further breakdowns in the quality of patient care.

Despite the Recession, Many Local Labs Thrive

Secret is priority emphasis on lab operations, complimented with strong outreach sales effort

CEO SUMMARY: Each year, the Executive War College offers useful perspectives on the current lab testing marketplace. This year's gathering took place as the recession deepened. Yet that didn't dampen the optimism and energy of 60 speakers and more than 450 attendees from 12 countries. Collectively, the 60 sessions offered credible evidence that those labs emphasizing operational excellence in tandem with a professional outreach sales effort are holding their own, despite the tough economy.

CMS Refuses to Return Competitive Bid Docs

Labs and trade groups are concerned that CMS will use the proprietary information in other ways

CEO SUMMARY: The Acting Secretary of Health and Human Services (HHS) has refused the request of three San Diego area labs for the return of their bid documents even though the competitive bidding demonstration project was repealed by Congress last July. The HHS Acting Secretary says he has no obligation to return the documents and he intends to use the information in the bid applications for "analysis purposes," according to court papers filed last month.

Pathology Innovations: Using Cellphones Like Microscopes To Help Lesser-Developed Countries

Researchers create "microscopes without lenses" that can transmit pathology images using cell phones

ER/PR Testing in Canada Continues to Make News

Cameron Report cites deficiencies, yet Canada seems slow to implement tighter lab accreditation

CEO SUMMARY: In Canada, the story about inaccurate breast cancer testing just won't go away. In March, the Cameron Report was made public with its assessment of lab testing failures in Newfoundland and Labrador. In April, the health system in those provinces admitted that it needed to review and possibly retest another 43 breast cancer patients. Calls for a uniform system of laboratory proficiency testing and accreditation have not yet motivate federal and provincial health officials to tackle this issue.

Biotech Start-Up Firms Hiring Lab Professionals

Early-stage molecular companies are recruiting experienced lab administrators, pathologists, MTs

CEO SUMMARY: It may be a tough job market right now laboratory professionals. But investors, lured by the potential personalized medicine and molecular diagnostics, continue pour investment capital into new companies. In turn, these companies are actively recruiting experienced clinical lab managers, pathologists, and technical staff. One management recruiter specializing in biotech placements offers insights and advice on clinical lab professionals can tap these job opportunities.

New Report: POC Market Will Grow 30% by 2013

New technology and smaller instruments offer advantages to patients, providers, health systems

CEO SUMMARY: It will be no surprise to lab directors and pathologists that Kalorama Information, in its latest report on point-of-care (POC) testing, estimates that glucose testing comprises 67% of this market segment. What is notable is Kalorama's prediction that worldwide POC testing will grow by 30% during the next four years. Because of new portable and handheld instruments, POC testing is migrating from hospitals to workplaces, homes, disaster sites, and convenience clinics.

INTELLIGENCE: Late & Latent

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