DID THE UNITED STATES AND THEWORLD DODGE A BULLET because the first outbreak of A/H1N1 influenza was neither as lethal nor as virulent as long-predicted by public health officials? That might be true today. But wait until the next flu season.

No one knows if the A/H1N1 virus will mutate in ways that make it more virulent and more lethal. Only time will provide the answer. Meanwhile, this spring's relatively short-lived A/H1N1 influenza outbreak has lessons for the laboratory testing industry—and many are described in this issue of THE DARK REPORT. Three separate intelligence briefings detail some rather remarkable stories of how laboratories and lab industry vendors met the unexpected challenges presented by the A/H1N1 outbreak. First is an analysis of how clinical laboratories and public health laboratories coped with the surge of influenza specimens. Influenza assays currently available to clinical laboratories are less than ideal when a new influenza strain like A/H1N1 appears. Also, the supply chain can be quickly overwhelmed, as laboratories increase their orders and vendors struggle to keep enough lab supplies in the distribution pipeline. (See pages 3-5.)

Second is a fascinating story about how the testing capacity and capabilities of many public health labs were increased literally overnight! A unique collaboration involving the Centers for Disease Control and Prevention (CDC), the Association of Public Health Laboratories (APHL), and Applied Biosystems, a division of Life Technologies Corporation, led to the installation and validation of 40 new molecular test systems in public health labs in this country because of a 24/7 crash program. (See pages 6-8.)

Third, THE DARK REPORT interviews two laboratory professionals about how their organizations stepped up to meet the increased volume of flu specimens that needed testing during the peak of the A/H1N1 outbreak. Both lab companies are gearing up for a busy flu season this fall and have useful advice to share with other pathologists and lab directors. (See pages 17-18.) In my view, the United States and the laboratory medicine profession got a lucky break with this outbreak of A/H1N1. Similar to the SARS outbreak in 2003, this country avoided a serious epidemic for reasons unrelated to preparedness.

However, the good news is that the public health establishment has greatly enhanced its ability to respond to similar outbreaks in the future.

Influenza A/H1N1 Outbreak Offers Lessons for Labs

Lack of influenza test capacity at peak demand is warning to private labs and public health labs

CEO SUMMARY: As influenza A/H1N1 spread, clinical labs nationwide learned that they did not have the capacity to test for an outbreak of flu that generated a 10-fold increase in sample volume. To move the samples through the system, many clinical labs ran extra shifts and ran short of supplies. It was a similar situation at public health laboratories, which were inundated with influenza specimens and sometimes a week behind in reporting results. In turn, that meant health officials were often days behind tracking the flu outbreak.

CDC, Public Health Labs Added Flu Test Capacity

Crash program beefs up capacity & capabilities of public health laboratories in U.S and abroad

CEO SUMMARY: Discovery of the A/H1N1 strain of influenza made it imperative that public health laboratories in the United States, Mexico, Canada, and other countries have more molecular testing capacity and capabilities in support of efforts to track and control the outbreak. Applied Biosystems, a division of Life Technologies Corporation, stepped into the breach, upgrading existing public health lab instrument systems while installing 40 more instruments in the United States and 60 additional instruments in countries across the globe.

FDA Enforcement Update: 35 Firms Get FDA Warning Letters Regarding Various Swine Flu Claims

Accreditation with DNV Helps Hospital Raise Inpatient Volume

Earns Dual Medicare and ISO 9001 Accreditation

CEO SUMMARY: In Utica, New York, 201-bed St. Elizabeth Medical Center was the first hospital in New York State and one of the first five hospitals nationwide to meet the new accreditation standard from DNV Healthcare, of Cincinnati, Ohio. St. Elizabeth administrators credit use of this new accreditation process in helping the hospital improve efficiency, patient satisfaction, and employee retention. Meeting the DNV accreditation standards was relatively easy because the facility was already accredited for ISO 9001 and ISO 14001 from the International Organization for Standardization (ISO).

Lab Marketing Update: Mickey Mouse to Educate Kids About Allergy Lab Test Options

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

Influenza A Test Is a Help When Screening for H1N1

In anticipation of the next flu season, some labs are expanding flu test capacity and capabilities

CEO SUMMARY: ViraCor Laboratories is preparing to handle expanded volumes of influenza testing prior to the start of the next flu season. It will use added instrumentation and expanded working hours to expand capacity. Another strategy is to use influenza A testing as a way to reduce the overall number of influenza specimens that might need to be referred for additional testing. New molecular tests offering better sensitivity for influenza are also entering the clinical marketplace.

INTELLIGENCE: Late & Latent

GE ANNOUNCES $6 BILLION TO FUND HEALTH INITIATIVES

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