E-Learning for Clinical Laboratories
With the rapid reduction of trained professionals creating an increased workload for laboratorians, the time for additional education for those performing more than one role in the laboratory has become almost nonexistent. Additionally, the industry’s learning environment has evolved into one in which teaching and learning does not necessitate live professors and textbooks.

Beckman Coulter has developed programs especially designed to provide the industry with an alternative to classroom learning. The company recently added a new Webinar entitled C-Reactive Protein—Acute Phase Protein or Cardiovascular Risk Marker? The course, which is available at www.beckmancoulter.com/labquality, offers a flexible method for laboratories to build and maintain staff competencies. Users can access the Webinars from any computer with Internet access, which enables individual paced progress while avoiding the time and expense of off-site training.

The new course addresses C-reactive protein (CRP) and its use in providing additional information to traditional markers of coronary artery disease (CAD). CRP and cholesterol measurements can deliver risk assessment for adverse CAD events in apparently healthy individuals. The course also details the implementation of a risk-assessment program using CRP and lipids. The CRP course is approximately 40 minutes long and is hosted by Bernard Cook, PhD, MT (ASCP), lead scientific advisor for Beckman Coulter.

The company’s Webinars include discussions on cardiac and tumor markers, drug testing, osteoporosis, diabetes management, hemostasis, and cellular analysis.

In addition, Beckman Coulter’s e-learning offerings include the Lab Training Library, a collection of courses designed to educate lab technologists about clinical conditions, medical procedures, and lab testing protocol.

Further strengthening the company’s online educational offerings, Beckman Coulter has released a new electronic Interlaboratory Quality Assurance Program (eIQAP) for its hematology analyzers.

The eIQAP service allows clinical laboratories to submit, share, and receive hematology quality assurance (QA) information quickly and efficiently via a secure Web site. The program simplifies and automates the submission of QA data, eliminating clerical hassles and processing time. Laboratorians enrolled in the program will no longer be required to mail diskettes with QA information to Beckman Coulter for uploading to a master IQAP database.

Users who submit their QA information through eIQAP receive results via email in 24 hours. Additionally, eIQAP users may access current and historical lab reports from the previous 12 months. The reports include a statistical peer comparison, enabling labs to benchmark their QA results and proficiency alongside other laboratories to improve their performance or prepare for accreditation inspection. For laboratorians with limited Web access, reports may be delivered via email upon request.

Currently, laboratories in the United States and Canada are eligible to participate in the program; however, users of eIQAP must be enrolled in the program and register on the Beckman Coulter Web site. High-speed Internet access and certain computer operating requirements are needed.

Contact: Beckman Coulter
(800) 526-3821; www.beckmancoulter.com

COLA and the American College of Physicians to Offer Turnkey Program for Interns
The new lab alliance program offered by COLA and the American College of Physicians (ACP) offers laboratory interns a turnkey solution to cost-effective laboratory accreditation, proficiency testing, and education that meets CLIA requirements.

 The turnkey program allows ACP/MLE (Medical Laboratory Evaluation) members to take advantage of a service package that bundles laboratory accreditation, e-learning courses, and educational products with MLE’s proficiency testing at a major cost savings over other service providers. Additionally, MLE will waive the administration fee for existing COLA members who enroll in the organization’s initial proficiency testing program.

“Profitable and high-quality labs result from the same approach through accreditation and proficiency testing, expert advice, and valuable educational resources,” says John Tooker, MD, MBA, FACP, who is ACP’s executive vice president and CEO. “The products and services offered through this alliance with COLA provides what is needed to improve patient care and to run a lab efficiently and economically.”

Contact: COLA (410) 381-8611; www.cola.org

Prominent Pathology Organizations Team to Offer New Certification
The American Association of Pathologist Assistants (AAPA) has been accepted as a participating member of the American Society for Clinical Pathology (ASCP) Board of Registry (BOR) Board of Governors. The two organizations have paired in an effort to offer the only professional certification for pathologist assistants.

 “The national certification for pathologist assistants is the realization of a long-held dream,” says AAPA member James Moore, MHS, who worked closely with the ASCP BOR to establish the certification program. “In 1972 when the AAPA was formed, its primary purpose was to establish and maintain appropriate educational and professional standards for those working in the field and to seek national recognition and certification for its members.”

“Pathologist assistants are physician extenders much like physician assistants,” adds Thomas Reilly, AAPA board of trustees chair. “They are extensively trained and educated to provide complex anatomic pathology services under the supervision and direction of licensed, board-certified pathologists. It is not within their scope of practice to render a diagnosis. That is the responsibility of the pathologist.”

According to Patricia Ellinger, MSEd, MT(ASCP)SBB, chair of the ASCP BOR Board of Governors, current AAPA fellows can obtain certification through the BOR by submitting an application to the BOR between October 1, 2004 and December 31, 2005. After December 31, 2005, all individuals seeking certification will have to pass the BOR certification examination to earn the credential. The certification will have multiple routes, similar to other BOR certifications. Examination applicants must be graduates of a pathologist assistant educational program accredited by the National Accrediting Agency for Clinical Laboratory Science or be able to demonstrate that they have met specific training and work experience requirements.

Ellinger expects the demand for pathologist assistants to increase over time. “If the patient population continues to grow, the need for laboratory services and pathologist assistants will grow too.”

“We are producing fewer pathologists than we used to, which is fueling the need for pathologist assistants,” adds Reilly. “And, I expect national certification to increase our visibility and possibly create additional demand.”

Contact: American Society for Clinical Pathology (312) 738-1336; www.ascp.org/bor

Study in Dermoscopy Reveals Breakthrough for Diagnosing Melanoma
According to the ECRI, melanoma is the fifth-leading type of cancer in terms of incidence. It is curable by excision, but there is no cure for metastatic disease. The difficulty of detecting melanoma and the consequences of missed diagnoses are reflected in the fact that melanoma accounts for only 5% of skin cancers but for 80% of deaths from skin cancer.

 ECRI recently analyzed published studies to assess the effectiveness of dermoscopy (also referred to as dermatoscopy or epiluminescence microscopy) versus visual clinical examination. The organization also compared the various ways to interpret dermoscopy images, such as pattern analysis and the ABCD rule, which assesses lesion symmetry, border, size, and color.

The organization found that dermoscopy used by itself is more effective for diagnosing melanoma than just a clinical exam. However, ECRI researchers also found that dermoscopy alone is not as effective as the combination of dermoscopy and a clinical exam, and should not be used to replace clinical examination.

Physicians use dermoscopy to improve visual clinical examination of suspicious skin lesions. The procedure uses 10x or greater magnification and close surface lighting after oil is applied to the space between the skin and the lens to render the skin more transparent. Dermoscopy allows a closer look at the subsurface details of the lesion. Oil may not be necessary if a polarized light source and lens are used.

ECRI’s meta-analysis found that dermoscopy was significantly better than the clinical examination, but adds that ideal results are obtained when the results from both tests are combined. The organization states that further research is needed to compare dermoscopy with other diagnostic methods to assess whether this method, or any other, is more effective.

ECRI published its findings in its technology assessment report, “Dermoscopy for the Diagnosis of Melanoma and Other Forms of Malignancy.”

Contact: ECRI (610) 825-6000; www.ecri.org

District Court Awards Integra LifeSciences $6.37 Million in Damages
The United States District Court for the Southern District of California has ruled in favor of Integra LifeSciences Holdings Corp in its case against Merck KGaA. Merck KGaA was accused of infringing four of Integra’s licensed patents. The court has ordered Merck KGaA to pay Integra LifeSciences $6.37 million in damages.

The district court ruling follows a June 2003 order of the United States Court of Appeals for the Federal Circuit affirming the trial court’s earlier finding that Merck KGaA had infringed four of Integra’s licensed patents, vacating the trial court’s award of $15 million in damages and remanding the case back to the trial court for further factual development and recalculation of damages.

The lawsuit, which was filed in 1996, alleged that Merck KGaA and a nonprofit research institution under contract from Merck KGaA had infringed various United States patents held by the Burnham Institute of San Diego that have been licensed to Integra. The patents relate in various ways to technology involving peptides containing an arginine-glycine-aspartic acid (RGD) sequence or related cell surface receptors. Compounds containing the RGD sequence promote or inhibit cell adhesion by binding receptors, called integrins, found on the surface of almost every cell in the body.

“We are pleased that the District Court has, once again, awarded substantial damages for Merck’s infringement of our patents,” says John Henneman, III, executive vice president and chief administrative officer of Integra.

The order of the District Court remains subject to appeal. Accordingly, Integra has not recorded any gain as a result of this order or the earlier jury verdict.

Contact: Integra LifeSciences Holdings Corp (800) 654-2873; www.integra-ls.com

LifePoint System Used in City Drug Courts
Over the past decade, 1,400 drug courts have been established across the country. The rapid growth of these courts is attributed to data showing that drug courts succeed in reducing drug use, improving recidivism rates, and generating cost savings to the judicial system. Drug offense probation, in which the average probation client reports two to three times per week to the probation officer or judge to be screened for drug use, is often used instead of jail for those convicted of drug offenses.

In an effort to meet the increasing demands of the criminal drug screening market, LifePoint Inc developed its IMPACT® test system, which is an on-site diagnostic test that simultaneously detects drugs of abuse and alcohol. The company recently announced that the Oklahoma City Department of Court Administration has fully adopted the IMPACT test system.

“The [IMPACT] system has proven to be an easy-to-use and effective tool for testing our probation clients, especially juveniles,” says LaShawn Thompson, chief probation officer, Oklahoma City Department of Court Administration. “The city has added the saliva-based test system to its testing protocol in order to eliminate problems with gender-specific urine sample observation, and concerns regarding adulteration and substitution that can occur when collecting and testing for drugs.”

“The acceptance of the IMPACT system in the drug court community is great news. It enables more reliable tests while helping to reduce drug usage,” says Linda Masterson, president and CEO of LifePoint.

Contact: LifePoint Inc (909) 418-3000; www.lifepointinc.com

Sigma-Aldrich Gives $1.5 Million in Donations to Area Schools

When Sigma-Aldrich obtained a new student intern from the University of Missouri, the company had no idea it would soon find itself donating $1.5 million worth of laboratory equipment to area schools. Upon discovering equipment stocks in excess of the company’s short-term needs, the intern launched an email campaign asking 125 local high schools and 15 area universities and colleges if they had any interest in the equipment.

According to Mike Hogan, CAO and CFO of Sigma-Aldrich, area schools reviewed the list of what was available and indicated preferences for equipment that would best meet their needs. Recipient schools chose their equipment from more than 100 items, including stirrers, flasks, pipettes, gloves, textbooks, weighing scales, thermometers, pumps, tubes, timers, and other high-tech items.

“Schools were accepted on a ‘first come, first served’ basis,” says Hogan. “Some schools requested relatively small amounts of equipment while the Special School District of St Louis received roughly half of all the equipment that was donated.”

Major beneficiaries include the University of Missouri at St Louis, St Louis University, Harris-Stowe College, St Louis Public Schools, the Special School District, Saint Dominic High School, and the Donald Danforth Plant Science Center. The Francis Howell School District, Christian Outreach School, Parkway School District, Saint Raphael the Archangel School, and Althoff High School also received donations from the company.

“One or two minor overlaps in requests were worked out fairly among the requesters,” adds Hogan. “Based on the letters of thanks the company has received, all the schools appear to be very pleased with what they were able to receive through the program.”

The 2004 donation program to area schools was not the first time the company has been involved in philanthropic activities. According to Hogan, Sigma-Aldrich staff scientists serve as ambassadors/teachers in the classrooms of area schools.

“Though this summer’s program dealt with excess stock, the company also has donated equipment from active inventories to educational organizations teaching environmental and other scientific disciplines to kids in Milwaukee and other cities as part of its overall charitable giving program,” says Hogan. “Faced with excess stock at some point in the future, Sigma-Aldrich would be delighted to once again help area schools.”

Contact: Sigma-Aldrich (800) 325-5052; www.sigma-aldrich.com

Isensix Expands Technology at UCLA
As the flagship hospital of UCLA Healthcare, the UCLA Medical Center is a leader in adopting new technologies that improve patient safety and the quality of its internal processes. In an effort to keep the institution current with technological advancements, Isensix Inc has expanded its advanced remote-monitoring system (ARMS™) throughout the clinical and pathology laboratories of UCLA Healthcare.

The ARMS equipment continuously monitors the temperature, humidity, and environmental parameters of sensitive resources and specialized areas. The system was initially installed in UCLA Medical Center’s blood bank and operating rooms. However, recent installation activity has expanded the network to the laboratories of UCLA Medical Plaza, the Brentwood testing facility, and Santa Monica–UCLA Medical Center. The clinical departments supported at these locations include transfusion medicine, microbiology, serology, surgical pathology, autopsy, clinical chemistry, and cytogenetics.

“After witnessing the safety and quality improvements the ARMS system provided to the blood bank, we decided to extend the scope of the network to all of our clinical and pathology laboratories,” says David Bruckner, chief operating officer of clinical laboratories for UCLA Healthcare.

Contact: Isensix Inc (866) 634-2767; www.isensix.com

FDA Clears In Vitro Diagnostic Label to Test for Telithromycin
Trek Diagnostics Systems has received 510(k) clearance for its JustOne® Telithromycin for Sensititre® MIC susceptibility plates. The company received clearance to test and report telithromycin against bacterial groups using Sensititre MIC susceptibility methods, such as Staphylococcus species, Streptococcus pneumoniae, Streptococcus species, and Haemophilus influenzae.

 “Our dry-plate technology allows us to work closely with pharmaceutical companies during the dried-plate drug development process,” says Jenny Lorbach, global product manager for Sensititre. “Telithromycin is now available in the JustOne format, and will soon be available for our automated customers in standard MIC plate formats.”

Telithromycin is available for inclusion on custom plates or can be tested on JustOne for telithromycin. Sensititre MIC plates for Streptococcus pneumoniae and gram-positive isolates containing telithromycin are now available.

Contact: Trek Diagnostic Systems Inc (800) 871-8909; www.trekds.com

Arnot Health Connects Hospital and Physician Offices Via Misys Optimum
Misys Healthcare Systems recently announced that Arnot Health (a combination of Arnot Ogden Medical Center and Arnot Medical Services) will purchase the Misys EMR™ physician office ambulatory clinical solution for the Arnot Health affiliated physician group.

 The purchase was made by Arnot in an effort to better medical decision-making, increase efficiencies, and improve hospital-physician relations within its facilities. The agreement between Arnot and Misys marks the first Misys Optimum™ sale to interconnect care settings with electronic health records (EHRs) to enable the sharing of critical clinical data.

“The IT investment is a demonstration of commitment to establishing a community-shared EHR accessed by both our hospital-based and community-based doctors to assure continuity of care,” says Anthony Cooper, CEO, Arnot Ogden Medical Center. “We’re excited about Misys Optimum, which mirrors our own long-term approach to manage safer care and minimize medical errors. The efficient exchange of just-in-time data across care delivery settings promises countless benefits to patients and caregivers alike.”

The contract between Misys and Arnot Health includes options to purchase Misys Image Management™ powered by eRad/ImageMedical™ developed technology, Misys Media Manager for the hospital, and Misys practice management solution paired with Misys EMR for community-based physician practices.

Contact: Misys Healthcare Systems (866) 647-9787; www.misyshealthcare.com

Abbott and BioGenex to Distribute and Market New System
Abbott Laboratories and BioGenex Laboratories have joined forces to distribute and market a new system that will fully automate molecular diagnostic tests that employ Abbott’s proprietary fluorescence in situ hybridization (FISH) technology.

FISH technology provides the ability to see multiple chromosomal abnormalities simultaneously in a single cell and to visually assess these genetic abnormalities in patient specimens. FISH-based tests use DNA probes labeled with colored fluorescent tags that bind to specific gene sequences on human chromosomes.

The new system is designed to automate all of the assay steps required to perform Abbott’s FISH-based tests, including the application, removal, and reapplication of the coverslip, resulting in a completely finished slide that is ready to go directly on the microscope for review. The collaborative technology is expected to be introduced to the market in the near future, pending regulatory clearance.

“The increasing demand for molecular testing is putting pressure on clinical laboratories to process these tests more quickly,” says Edward Michael, president, Abbott Molecular Diagnostics, Abbott Laboratories. “By further automating our FISH technology, we can help our customers keep up with the workflow demands, save labor costs, further enhance test reliability, and improve patient care.”

Under the terms of the agreement, Abbott has coexclusive rights with BioGenex to market and distribute the new system worldwide in the FISH field. Abbott and BioGenex will collaborate to further develop automated solutions for FISH applications. As part of the agreement, BioGenex has received a multiyear minimum volume commitment and an up-front payment toward future purchases of systems.

Contact: Abbott Diagnostics
(800) 323-9100; www.abbott.com