Challenges for the use an implementation of electronic health records (EHRs) are well documented, but this study in the journal Genetics in Medicine discusses another notable aspect—EHRs will need vast improvements to meet the needs of genetics and genomic medicine. The study notes that EHRs will need improved structure, standardization and functionality to house the genetic information that is slowly changing patient care.

Most EHRs—even state-of-the-art ones—lack the ability to systematically record genetic information, let alone use it for medical decision making, the report notes. Although the need to house and utilize such information now may be relatively low, it’s a safe assumption that the need will only continue to increase.

Preparing for these future needs now could save many headaches when the time comes that genetic information is routinely used. As vendors roll out updates and new products, hopefully the need for genetic and genomic data is considered.

It may be true that the term “going green” has turned into quite the trite cliché, but that doesn’t make environmentally aware practices any less important.

For an event as huge as the AACC Annual Meeting and Clinical Lab Expo, eliminating waste and being environmentally conscious can be a challenge—but small efforts can have major impacts. This year, conference program and exhibit guides, CLN Convention Dailies and promotional materials are all printed on 30 percent recycled paper, and the conference tote bag that all attendees receive is made of 51 percent recycled fabric (of course, the benefits of these bags extends far past the few days we’re using them at the meeting—keep yours in your car and take it with you when you go grocery shopping to reduce your plastic bag use).

The badge holders will also be recycled at the end of the show, and AACC carefully used more trunks than cardboard boxes to ship supplies to the convention center. The AACC staff will also use china instead of disposable dining materials.

Even better, McCormick Place Convention Center is a Leadership in Environmental and Energy Design (LEED®) Certified Green Building. LEED is the system used by the U.S. Green Building Council (USGBC) to design and construct energy efficient buildings. According to the convention center’s press release, a few features that led to this certification include:

• One of Chicago’s largest green roofs, covering approximately 150,000 square feet.

• A 3,100 foot long storm water tunnel, located 150 feet below grade, which will divert approximately 55 million gallons of storm water into Lake Michigan every year.

• A highly efficient irrigation system consisting of timed sprinklers, moisture sensors, and drip irrigation tubes, reducing the use of potable water for landscape irrigation by 50 percent.

• A well-insulated building envelope, energy efficient mechanical systems, and lighting, which will reduce the energy cost of the building by more than 20 percent.

• Materials with high-recycled content, including steel, gypsum board and acoustic ceiling tiles.

• Building materials (more than 20 percent) that were extracted and manufactured within 500 miles of the building site, thereby supporting local economies and reducing the environmental impact resulting from long-distance transportation.

McCormick Place will also help the AACC in its green efforts by recycling exhibiting companies’ discarded packing materials and making it easy for exhibitors and attendees alike to recycle throughout the facility. We encourage everyone attending the conference to play their role by recycling and reducing the waste they produce and help the AACC and McCormick Place Convention Center achieve their green goals.

Your ADVANCE reporters are arriving on scene to the AACC Annual Meeting in Chicago, and the McCormick Place Convention Center is bustling with attendees eager to check out a variety of sessions before the exhibit hall opens tomorrow.

The conference is also the time that important leaders in the field of clinical laboratory medicine are recognized. This year's award recipients are:

• The Wallace H. Coulter Lectureship Award-Jerome E. Groopman, MD, the Dina and Raphael Recanati Chair of Medicine at Harvard Medical School, and chief of experimental medicine at Beth Israel Deaconess Medical Center.
• Outstanding Lifetime Achievement Award in Clinical Chemistry and Laboratory Medicine-Christopher P. Price, PhD, FACB, an independent consultant focused on outcomes research, a visiting professor in clinical biochemistry at the University of Oxford, and clinical director of the Cumbria and Lancashire Pathology Commissioning Network.
• The Morton K. Schwartz Award for Significant Contributions in Cancer Research Diagnostics-Catharine M. Sturgeon, PhD, FRCPath, FACB, a consultant clinical scientist in the department of clinical biochemistry at the Royal Infirmary of Edinburgh, director of the National External Quality Assessment Service’s proficiency-testing center, and an honorary senior lecturer at the University of Edinburgh.
• Award for Outstanding Contributions through Service to the Profession of Clinical Chemistry-Donald S. Young, MD, PhD, FACB, acting director of clinical chemistry at the Hospital of the University of Pennsylvania.
• Award for Outstanding Contributions in Education-Michael Laposata, MD, PhD, professor of pathology and medicine at Vanderbilt University School of Medicine, and pathologist-in-chief and director of clinical laboratories at Vanderbilt University Hospital.
• Award for Outstanding Contributions to Clinical Chemistry in a Selected Area of Research-Fred S. Apple, PhD, DABCC, medical director of clinical laboratories, clinical chemistry, toxicology, and POCT at Hennepin County Medical Center in Minneapolis, professor of laboratory medicine and pathology and of kinesiology at the University of Minnesota School of Medicine, and a forensic toxicology consultant for the Hennepin County medical examiner’s office.

Dr. Groopman also delivered the opening plenary session titled "How Doctors Think," based on his recent book of the same title, discussing how physicians diagnose and prescribe treatment to patients and how misdiagnosis can occur.
Hot topics at the conference will be familiar to readers of ADVANCE for Administrators of the Laboratory: Vitamin D testing, cardiac biomarkers, improving methods for diabetes diagnosis and management, and personalized medicine and pharmacogenomics.

Stay tuned for coverage of these topics and many more!

Your ADVANCE reporters are eagerly preparing for the AACC Annual Meeting and Clinical Lab Expo in Chicago next week. We look forward to checking out the latest and greatest technologies, attending information-packed educational sessions, and most of all, interacting with you, our readers.

We value conferences like AACC/ASCLS as opportunities to get feedback from you and learn what you like and what you’d like to see more of. If you see us—notebooks in hand and press badges hanging from our nametags—please don’t hesitate to say hello and let us know your thoughts.

We’ve already started our online coverage—click here for a conference preview article, a guide to Chicago restaurants and attractions, and exclusive Webcasts—and we'll be adding much more during and after the conference.

You can find us on Facebook and Twitter, where we’ll post photos from McCormick Place Convention Center and provide live updates on what we’re seeing and doing. Will you be using any forms of social media while at the conference? Leave us a comment and let us know how you’ll be utilizing such forums, and how you’d like to see us use it.

Let us know, also, what you’re looking forward to most at AACC/ASCLS ’09. We appreciate your feedback.

Enjoy Chicago!

While we're well past the end of "normal flu season," pandemic H1N1 has caused a second flu season in the U.S., as illustrated in this graph from the Centers for Disease Control and Prevention.

A great deal of influenza is still circulating throughout the United States, and almost all of it is H1N1. Laboratorians should be prepared for what could be a very busy flu season this winter, when confined spaces and the usual factors affecting influenza spread will combine with the novel strain. Labs should have a protocol and plan in place to deal with what may be drastically increased flu numbers as the seasons change.

The A1C assay continues to gain ground as a potential replacement test for the diagnosis of diabetes after an international committee of experts recommended the test at the American Diabetes Association Scientific Sessions this weekend.

The assay is traditionally used to monitor how well a patient is controlling his diabetes, but may be a more stable and reliable diagnostic tool than the fasting plasma glucose test or the oral glucose tolerance tests usually used. The international committee was assembled by the American Diabetes Association, International Diabetes Federation and European Association for the Study of Diabetes, but those organizations have not officially endorsed the report, according to this article on CNN.com.

One session at the American Society for Microbiology this morning was titled "Code Sepsis: Clinical Microbiology Responds to Sepsis." Donna Wolk from the University of Arizona reiterated some of the staggering numbers associated with sepsis: It's the tenth leading cause of death in the United States, translating into 600 patients dying each day. Sepsis results in approximately $16 billion in hospital inpatient costs, says Wolk.

The microbiology lab plays a critical role in identifying and managing sepsis, and needs to remain cognizant of the many important factors involved in effective identification of pathogens that can cause sepsis. For example, the timing of blood draws for culturing is critical, Carol Spiegel, University of Wisconsin says. Draws should be performed prior to the start of antibiotic therapy and at the onset of a new fever in a patient. It's also important to perform two draws, so that if one culture is positive, the lab can differentiate between endocarditis, bacteremia and a contaminant.

Finally, says Spiegel, the amount of blood drawn is the "single most important factor influencing sensitivity of blood cultures." For adults, 30-40 mL of blood should be cultured; volumes for children should be determined by weight.

Wolk stresses the importance of implementing rapid methods of detection to allow physicians to start targeted therapy sooner and minimize the use of broad-spectrum antibiotics. For hospital microbiology labs, she suggests collaboration with the ICU and emergency department teams to best manage sepsis.

This afternoon brought a late-breaking session at ASM to discuss lab response to H1N1 swine flu. As ADVANCE has previously reported, the consensus seems to be that thanks to the terrific response of healthcare workers--certainly including laboratorians--what might have been a major public health crisis was handled efficiently, avoiding what could have been a far worse situation.

Christine Ginocchio, PhD, MT(ASCP), director of Microniology/Virology and Molecular Diagnostics at Long Island Jewish Health System Laboratories explained how her lab went from zero to 60 to handle the influx of testing and be prepared for continued increase in testing. "It's amazing what an outbreak can do," she said.

Dr. Ginocchio detailed some of the problems her lab faced. They went from a normal testing volume of about 160 tests a day to 790. The lab needed supplies and accessioners for specimen receipt, a system for triaging all of these specimens, not to mention LIS support for all of these extra test results.

The lab put an emergency plan in place and developed a specific testing algorithm, starting with a rapid test or viral culture, then PCR for further typing of Type A specimens. Those that came back as "probable swine flu" went on for further CDC testing. On top of the logistics of testing, the lab actually did some emergency construction to expand the physical space! "Essentially," Dr. Ginocchio said, "we were building a lab in four days."

All of the necessary teams came together in a remarkable way, though, from the lab staff and all of the couriers, to the information technology team and construction workers, and with an impressive amount of collaboration, they were able to effectively manage the emergency.

Calling in for an audioconference, Dr. Joe Miller from the CDC discussed the sequence of events since the identification of the first H1N1 case. As of this morning, he reported, the U.S. has 5,469 confirmed cases, including 229 hospitalizations and six deaths (with a possible seventh not yet confirmed).

Tuesday morning at ASM started with a symposium titled “Update on Gram-negative Pathogen Resistance and Lab Methods of Detection." To recap, David Landman from the State University of New York Downstate Medical Center in Brooklyn discussed resistance challenges with acinetobacter. Many strains have an outer cell membrane that is relatively impermeable to antibiotics, making it a highly resistant pathogen. Because of this, patients with acinetobacter infections face a high mortality rate. For more on acinetobacter, check out the current feature on the ADVANCE for Administrators of the Laboratory Web site.

Kenneth S. Thomson from Creighton University in Omaha discussed KPCs and carbapenemases and their association with false susceptibility. Thomson made an interesting note on reporting in vitro susceptibility for carbapenemase producers. Because of uncertainty in carbapenemase screens, laboratorians can report that a pathogen is resistant to carbapenemases, recommend an infectious disease consult, or call up a physician and comment on unproven clinical efficacy and explain that the results can't be fully interpreted. This, of course, requires an established relationship with the physician, a need that grows increasingly apparent as lab test results grow increasingly less cut-and-dry.

Nancy Hanson, PhD, also from Creighton University, discussed the need for molecular detection of hidden beta-lactamases. Assessing these beta-lactamases is essential for resistance detection, and Dr. Hanson notes that vigilant surveillance for infection control is more important now than ever before. Commercially available phenotypic tests for ESBLs, AmpCs and carbapenemases are imperfect due to variable susceptibility patterns. Thus, she states, microbiologists should demand commercially-available molecular tests for CTX-Ms, AmpCs and carbapenemases.

What a great day at the ASM General Meeting. After interesting educational sessions, fascinating poster presentations and making the rounds on the exhibit hall floor, your ADVANCE reporter is excited to begin planning new coverage.

Patrick Duffy of the Seattle Biomedical Research Institute, Richard Sack of Johns Hopkins Bloomberg School of Public Health and Elisabeth Carniel of the Pasteur Institute held a special press conference about eradicating diseases of antiquity, such as malaria, cholera and the plague. They stressed that the focus should not be on eliminating these diseases, but controlling them. Challenges exist, but as we've seen from the near-elimination of these diseases in certain parts of the world, control is necessary, and lives can be saved.

An afternoon symposium asked if molecular detection and genotyping assays would render culture-based microbiology unnecessary. Brian Sauders, PhD, at the New York State Department of Agriculture and Markets, offered a brief history of microbiology--starting with selective enrichment or agar media for isolation of new and emerging pathogens, eventual development of new chromagenic agars for gram positive and gram negative organisms, automated blood culture systems, and more recently, rapid identification strips and automated antimicrobial sensitivity characterization. Culture-based microbiology, he reminds, has matured over the past 150 years, and although molecular-based assays are quickly gaining ground, they've really only been around for the past 20 years--and for many labs, much less than that.

As always, the exhibit hall is bustling with vendors offering some of the latest and greatest in microbiology equipment. Stay tuned to ADVANCE ASM Conference Coverage for a product slideshow, featuring highlights from the exhibit hall.

The American Society for Clinical Pathology (ASCP) and the College of American Pathologists (CAP) have joined the American Civil Liberties Union and at least 18 other plaintiffs in a lawsuit challenging the legality of patents on human genes—specifically, patents covering the BRCA1 and BRCA2 genes, which are associated with breast and ovarian cancer. The lawsuit was filed May 12 against the U.S. Patent and Trademark Office (PTO), Myriad Genetics, and Directors of the University of Utah Research Foundation in U.S. District Court in the Southern District of New York.

“ASCP joined this lawsuit because a fundamental tenet of ASCP is that patients come first,” says ASCP President Barbara J. McKenna, MD, FASCP. “Gene patents violate this principle by creating unjustifiable monopolies on human genetic information that is critical in the diagnosis of many diseases.”

ASCP asserts that gene patents limit the availability of diagnostic tests since laboratory scientists are prohibited from performing genetic tests because of patent enforcement and the threat of litigation. Also, the market is dominated by a single provider, eliminating competition and scientific diversity and driving up costs, the group says. ASCP adds further that gene patents potentially infringe on patients’ rights by denying them access to their own genetic information as well as stifling innovation and refinement in test methodologies and quality and hindering access for the uninsured and those whose health care coverage requires reimbursement by a third-party payer.

According to CAP, patients are adversely affected because Myriad restricts most laboratories from providing full gene testing, forcing patients and their physicians to rely solely on Myriad to provide the test.

“As medical specialists in the diagnosis of disease, pathologists have a keen interest in ensuring that gene patents do not restrict the ability of physicians to provide quality diagnostic services to the patients they serve,” says CAP spokesperson, Jeffrey A., Kant, MD, PhD, immediate past chair of CAP/ACMG Biochemical and Molecular Genetics Resource Committee and professor of pathology and human genetics at the University of Pittsburgh Medical Center.

“When patents are granted, a single lab only is authorized to do the test unless the test is licensed to other labs,” Kant adds. “In these cases, high licensing fees can be so prohibitive they prevent physicians and other laboratories from providing diagnostic services or developing improved tests.”

Myriad Genetics General Counsel Richard Marsh says company officials were surprised to be served with the lawsuit yesterday. “And I think it’s fair to say that the industry [was surprised] in light of the fact that, since 1980, the patent office has issued tens of thousands of gene and gene-based patents, “ attorney Marsh says. “But there’s been a lot of discussion with respect to the policy issue of patenting genes. There’s been bills introduced by the Congress. Congress has discussed [them], which is an appropriate forum to be discussing these policy-type issues. To our knowledge, this is the first time a suit of this nature has been brought. “

Though he was just having a chance to review the complaint and specific claims,” attorney Marsh made this statement: “This case is obviously about the policy of patenting genes or granting gene-based patents. That’s really the core issue of the case. As I mentioned before, we think this policy decision has already been decided by Congress and decided by the PTO, and if there’s a change in that, that’s Congress’s prerogative to make that. But at this point, without having had a chance to digest the complaint, it’s premature for Myriad to make any specific comments on the individual allegations of the complaint.”

The lawsuit states that the patents restrict ease of access by giving Myriad the right to prevent clinicians from independently looking at or interpreting a person’s BRCA1 and BRCA2 genes to determine if the person is at a higher risk of breast and/or ovarian cancer.

Women who fear they may be at an increased risk of breast and/or ovarian cancer do not have the option to have anyone look at their BRCA1 and BRCA2 genes or interpret them except for the patent holder. Women are thereby prevented from initially obtaining information about their health risks from anyone other than the patent holder or to obtain a second opinion.

The patents also prevent doctors or laboratories from independently offering testing to their patients, externally validating the test, or working cooperatively to improve testing. Many women at risk cannot be tested because they are uninsured and/or cannot afford the test offered by Myriad.

“Genes are not inventions like new treatments, drugs, diagnostic tests or technology platforms,” says Dr. McKenna. “They are products of nature that exist in all our bodies. No one deserves exclusive patent rights when all they did was uncover something that nature created or that nature does. Einstein couldn’t get a patent on E=mc² even though he worked very hard to discover it.”

ScienceInsider interviewed virologist Ruben Donis, chief of the molecular Virology and Vaccines branch at the CDC about genetics of the H1N1 virus causing the current swine flu outbreak, with some very interesting revelations.

The genome of the virus has been fully sequenced, and “it’s almost equidistant to swine viruses from the United States and Eurasia. And it’s a lonely branch there. It doesn’t have any close relatives.” Donis notes that the virus likely didn’t start in Mexico, as many seem to believe. Many mysteries remain before we can understand H1N1—its exact evolution, and why most of the cases in Mexico have been so much more severe than most of those in the U.S.

Check out the full interview here.

Unfortunate news for the laboratory industry: the University of Wisconsin School of Medicine and Public Health is cutting its Clinical Laboratory Science program, thanks to—you guessed it—budget cuts. Dr. Robert Golden, dean of the medical school, says the 80 students currently enrolled will be able to finish the program, but new students will no longer be accepted.

Such news is discouraging for an industry already facing an impending workforce shortage and severe lack of new graduates entering the field.