photo On Monday, Nov. 6, 2000, The Needlestick Safety and Prevention Act was signed into law by President Bill Clinton.

The law requires changes in the bloodborne pathogens standard in effect under the Occupational Safety and Health Act of 1970, to mandate health facilities to use safety needles. The bill also requires more consistent documentation of all needlestick injuries and requires that workers who provide direct patient care participate in evaluating which safe needles and sharps are used in their workplaces. The bill requires healthcare facilities to update and review their Exposure Control Plans to reflect changes in technology.

Rep. Cass Ballenger (R-NC) wrote the bill (H.R. 5178) that passed the house on Oct. 2, 2000 and the Senate on Oct. 26.

Study shows possible clinical benefit of Bayer HCV test
A study presented at this year’s 51st American Association for the Study of Liver Disease (AASLD) meeting reported on results of a new Hepatitis C (HCV) test that uses a molecular diagnostics technology called transcription mediated amplification or TMA. Study results showed that more than one-third of the patient samples that tested negative for HCV using the conventional PCR test were actually positive when tested by the new TMA test.

Dr. Stefan Zeuzem of the Zentrum der Inneren Medizin, (Frankfurt, Germany) presented results of a study in which 47 patient samples that had previously tested negative for HCV with existing PCR-based assays, were re-tested with the Versant HCV Qualitative RNA Assay from Bayer Diagnostics of Tarrytown, N.Y. The new study showed that 36 percent of patient samples that were diagnosed negative by the PCR assay were positive by the TMA test. After being tested with the conventional PCR test, all of these patients had relapsed after treatment was stopped. Zeuzem speculated that the results may have implications for the treatment of Hepatitis C, such as keeping patients on therapy longer in order to avoid relapse.

The Versant HCV RNA Qualitative Assay is available for Investigational Use Only in Germany and other parts of Europe, as the performance characteristics of this product have not been established. Qualitative testing for HCV using TMA technology is available in the United States as a service of the Bayer Reference Testing Laboratory in Emeryville, Calif.

The company recently released a new version of its quantitative HCV RNA assay, Versant HCV RNA 3.0 Assay (bDNA) available worldwide for research use only, not in diagnostic procedures. It is designed to quantitate HCV RNA over a range of values.

Diagnostica Stago funds coagulation education series
Diagnostica Stago of Parsippany, N.J., recently provided educational grants to three facilities that presented a series of coagulation education conferences for clinicians throughout the United States.

On October 13, Douglas A. Triplett, M.D., Dorothy M. Adcock, M.D., and Dan Kaczor, M.T.(ASCP) shared their knowledge regarding Heparin Therapy and D-Dimer Assay Utilization for Venous Thrombosis and Current Concepts in Heparin Patient Monitoring. More than 100 participants attended the conference at the Lehigh Valley Hospital in Allentown, Pa. Health Network Laboratories, also of Allentown, co-hosted the day long event.

For the second conference in New Orleans, Diagnostica Stago teamed up with Louisiana Coagulation Laboratory to sponsor the Louisiana Coagulation Conference 2000 on October 20. Experts included Charles Eby, M.D., Alexander Duncan, M.D., Patricia Massicotte, M.D., and Christine Daniele, M.T.(ASCP). Topics included HIT, ‘Fat Never Killed Anybody,’ Pediatric Thrombosis, and Anticoagulant Therapy and D-Dimer Testing. The more than 60 attendees included laboratorians and physicians. Gloria Coker, M.D., moderated the event.

The final educational conference was held on October 25 in Denver, where the company worked with Exempla St. Joseph Hospital. Speakers included Richard Marlar, Ph.D., who spoke on Heparin Monitoring; Kathryn Hassell, M.D., who presented information regarding HIT and Anticoagulant Therapy; and Alexander Duncan, M.D., who presented coagulation case studies.

The conference was concurrent with the American Thrombosis Association (ATA) meeting in Denver. Many local attendees took advantage of this opportunity to learn more about thrombotic disorders and speak directly to a panel of experts. The ATA is a non-profit organization devoted to increasing public awareness of thrombosis. Its Web site address is For information on future Diagnostica Stago conferences, check the company’s website at

Douglas BeigelCOLA CEO Kroger retires, COO Beigel promoted
National healthcare accreditation organization COLA of Columbia, Md., has announced the retirement of its CEO, J. Stephen Kroger, M.D., FACP, effective June 30, 2001. An original founder of the organization, Kroger was chairman of the organizing committee and acted as its founding president before becoming its CEO. COLA’s Board has appointed Douglas A. Beigel, currently COLA’s COO, as Kroger’s successor effective July 1. Beigel, who has been with COLA for 11 years, worked closely with Kroger in leading the organization.

Beckman Coulter signs agreement with Quest
Beckman Coulter Inc. of Fullerton, Calif., has signed an agreement valued at $30 million with Quest Diagnostics Inc. of Teterboro, N.J. Under terms of the five-year agreement, Beckman Coulter is named the sole-source provider of hematology instrument systems and related reagents for Quest’s U.S. lab network. In addition to the new agreement for hematology, Beckman Coulter has separate agreements with Quest covering certain chemistry, hemostasis, flow cytometry and other biomedical instrument systems and supplies.

Diagnostic Deals

Litigation filed by Igen International of Gaithersburg, Md., against Roche Diagnostics of Indianapolis has moved into the phase during which the parties may file for a summary judgment. Summary judgment motions allow the court to dispose of issues and claims without trial. Igen intends to file one or more summary judgment motions asking the court to rule that Roche has breached the license agreement between the two parties. A ruling in Igen’s favor could enable it to explore licensing arrangements with other partners.

    The lawsuit alleges that Roche breached a license agreement between the two companies. Igen granted Roche rights to develop and commercialize diagnostic systems based on Igen’s Origen technology within a specified field. Igen retained the rights to commercialize its technology in all other markets, including physician offices. The suit charges that Roche under-reported royalties owed to Igen and sold products outside the licensed field.

Beckman Coulter of Fullerton, Calif., has agreed to use Data Innovations’ Instrument Manager NT to address the interfacing needs of its various automation solutions, including its Power Processor Core System.

Premier Inc. of San Diego, in collaboration with Beckman Coulter and of San Diego, is developing Internet-based purchasing and information systems. Medibuy is Premier’s exclusive partner for e-commerce technology. Its applications allow Premier members to purchase Beckman Coulter and other vendor supplies via the Internet.

In other Premier news, the GPO has awarded two-year contracts for needlestick safety products to three new companies. Premier’s existing contract for safety syringes with Becton Dickenson continues. The new contracts include hinge-technology needle sheathing devices from Safety Medical Supply International Inc., of Waltham, Mass.; single-use retractable syringes from New Medical Technology Inc. of Zionsville, Ind.; and single-use retractable syringes from Abbott Laboratories of Abbott Park, Ill., through its marketing arrangement with Retractable Technologies Inc. of Little Elm, Texas.

Novation of Irving, Texas has signed a contract with Abbott’s i-STAT division for point-of-care testing equipment and cartridges. Abbott estimates sales from the 18-month contract could reach $50 million.

Joint Purchasing Corp. of New York, a non-profit health services operation, has opened an office in Hammonton, N.J., to better service healthcare facilities in Southern New Jersey and Philadelphia, where JPC’s membership is growing.

Serologicals Corp. of Atlanta, has been selected to participate in a Centers for Disease Control and Prevention HIV/HCV (Hepatitis C) Risk Factor Study. The CDC, in collaboration with Boston Biomedica Inc. of West Bridgewater, Mass., seeks to analyze the risk behavior characteristics of infected donors in order to improve the donor screening and deferral process.

Ventana Medical Systems Inc. of Tucson, Ariz., has received an FDA pre-market approval on its CB11 antibody for Her 2/neu diagnostic testing. The company’s PathWay HER 2 (clone CB11) is a monoclonal antibody that detects c-erbB-2 antigen in routine pathological samples on Ventana automated immunohistochemistry slide-staining devices.

Adventist Healthcare of Rockville, Md., which recently launched a system-wide quality initiative, is installing MEDai’s artificial intelligence software at its five hospitals and seven long-term care facilities. They plan to use it to help them better analyze and fine-tune their clinical outcomes.