January 2004 Newsbytes

Raymond D. Aller, MD;
Hal Weiner;
Michael Weilert, MD

Indoor positioning system tracks who, what, and where
An indoor positioning system that tracks staff, patients, and equipment is sending signals and exuding efficiency at Massachusetts General Hospital, Boston.

The system, developed by Radianse Inc., Lawrence, Mass., was implemented in December 2002 in Massachusetts General’s operating room of the future, a state-of-the-art suite for evaluating new perioperative processes and technology.

The IPS uses a combination of radio frequency and infrared waves for tracking. Battery-powered badges that can be worn by hospital staff and patients and attached to equipment send signals to receivers mounted on walls and ceilings. The receivers are connected to local area networks, which transmit data to Radianse’s location software. That data, which can include the flow of staff, patients, and equipment, is displayed on Web-enabled networked computers via regular text or a floor plan-type map.

The badges also have two buttons that can be programmed for various functions, such as sending an alert to signal an emergency or to notify staff that equipment is ready for reuse.

Massachusetts General is still evaluating the process improvements it has gained from the IPS, "but it looks like we have a 50 percent reduction in the time that is wasted between surgical procedures in other rooms, says Julian M. Goldman, MD, an anesthesiologist and director of clinical technology in the hospital’s operating room of the future.

The hospital is a beta site for the IPS and as such has received a grant from the National Institutes of Health for participating in the research. Dr. Goldman says the system has gone through many revisions, including a redesign of the badges to improve battery life and to improve the quality of information being transmitted. The LAN was also revised. "That included a complete hardware redesign, substantial software changes, and numerous changes to the entire system to make it more robust, Dr. Goldman says.

Massachusetts General is expanding the IPS to some of its regular operating rooms, which are located in five buildings and encompass about 22,000 square feet.

While the system has yet to be installed in a laboratory environment, Radianse CEO Reed Malleck says there are definite lab applications for the technology, including sample, staff, and equipment tracking. In such an application, the IPS would be integrated with RFID, or radio frequency identification technology, to provide such information as what samples were processed, by whom, on what equipment, and at what time. RFID is the technology used in security tags on consumer items and in security access cards.

The IPS would track the staff and equipment, while the RFID would track the samples, "and all the information would be integrated for ease of analysis, Malleck says.

"Whenever there’s a question, the system automatically has logged who was there, what equipment was used, and which samples were processed, he explains, adding that the technology could be ready for lab applications in about a year.

The first commercial installation of the Radianse IPS was scheduled for this month at Brigham and Women’s Hospital, Boston. A pilot system similar to the one at Massachusetts General was installed last fall at Toolo Hospital at the University of Helsinki, Finland.

Impac enters agreement to acquire Impath’s assets
Impac Medical Systems and Impath have entered into a definitive asset purchase agreement under which Impac will acquire substantially all of the assets and certain liabilities of Tamtron Corp. and Medical Registry Services, Impath’s PowerPath pathology information management and cancer registry information system businesses.

"This agreement significantly furthers our efforts to have all of the operating businesses of Impath emerge from Chapter 11 at the earliest possible date," says Carter Eckert, chairman and CEO of Impath.

Impath, Tamtron, and Medical Registry Services are operating as debtors-in-possession under the bankruptcy code after having commenced a Chapter 11 case on Sept. 28, 2003 in the U.S. Bankruptcy Court for the Southern District of New York.

The asset sale is subject to various bankruptcy court approvals and other customary closing conditions.

Impac Medical Systems
Impath Inc.

AABB conference focuses on the here and now and beyond
CAP TODAY contributing editor Hal Weiner attended the annual American Association of Blood Banks conference in November. His observations follow.

From thoughts on the future of medicine to the actions of the FDA, presentations at this year’s AABB meeting in San Diego offered a take on a variety of topics.

Perhaps the most interesting session was given by William M. Dwyer, divisional vice president of strategic marketing for Abbott Laboratories. Reflecting on the practice of medicine 25 to 50 years from now, Dwyer said several major trends are emerging, any of which is enough to "rock the world. These include genetic-based designer drugs, gene therapy, transgenic organ transplants, and nanotechnology.

Soon it will be possible to do pharmacokinetic studies in a doctor’s office for less than $1, Dwyer said. A physician may be able to prescribe drugs tailored to a specific individual. Vaccines using DNA sequencing may eradicate many common diseases. Gene therapy might be used to prompt growth of new vessels, eliminating the need for many heart surgeries. Genetically altered pigs could be used to grow near-human metric hearts, kidneys, lungs, and livers. These "grown-to-order transplants, combined with implanted biochips that automatically deliver the appropriate medication and perform constant real-time monitoring, could extend the human life span to two centuries, Dwyer predicted.

Nanotechnology could enable individually designed "nanobots to attack specific disease cells and augment the immune system, he explained. Computer technology may be radically changed through the implementation of biologic-based computers that solve complex problems at extremely fast speeds and at extremely low cost, he added.

Dwyer emphasized, however, that for all of these new technologies to come to fruition, they must be developed in concert with social and political issues and coupled with a global perspective.

Addressing a more timely topic, Win Stephenson, of the American Red Cross, presented an update on the latest regulations for use of electronic records and signatures. In August 2003, the FDA released "Guidance for Industry Part 11, Electronic Records; Electronic Signatures�Scope and Application (http://www.fda.gov/cder/guidance/5667fnl.htm). The document describes the FDA’s interpretation of how users need to apply FDA regulations to the implementation and validation of electronic medical records and use of electronic signatures.

"We are now re-examining Part 11, the FDA reports, "and we anticipate initiating rule making to revise provisions of that regulation. To avoid unnecessary resource expenditures to comply with Part 11 requirements, we are issuing this guidance to describe how we intend to exercise enforcement discretion with regard to certain Part 11 requirements during the re-examination of Part 11. The FDA statement adds that "the rules have been narrowed in scope [fewer types of records will need to be considered], and the FDA is still formulating strategies. In-depth validation plans will need to be documented and implemented for all programs, processes, and procedures where Part 11 applies.

Moving from presentations to products, AABB meeting attendees encountered an interesting assortment of laboratory items and services on the exhibit floor.

One of the more innovative products was the CritScan from HemaMetrics, a portable, noninvasive hematocrit device that provides an almost instant readout using transdermal technology. Using a photo-optical array, the device can read oxygen saturation and hematocrit counts from a finger tip.

The CritScan has received FDA 510(k) clearance but is not yet available for sale. The manufacturer is looking for appropriate distribution channels.

Another creative offering was featured at the Think360 company booth. Think360 has developed a blood donor marketing program that includes a personalized broadcast screen saver that can send messages to potential donors and that allows them to schedule appointments. The program also includes an online membership and reward program and personalized snack boxes and promotional products.

"Integrated marketing can increase staff productivity and improves donor satisfaction while reducing cost for donor food, said Alan Elias, president and CEO of Think360.

The company has numerous clients, including 40 blood center customers.

TransMed Software, Richmond, British Columbia, Canada, has introduced a complete blood inventory and management system specifically for small hospitals. The system provides patient and inventory management, reservation and issuance of products, product tracking, and management reports.

An entry level system, including a bar-code reader and printer, software, installation, and training, is expected to cost under $5,000. The product is pending FDA 510(k) clearance but has been installed in more than 40 sites in Canada.

In the wake of a Red Cross center in Irvine, Calif., quarantining 3,500 units of blood last September due to a malfunctioning refrigerator, several vendors have seen increased interest in their environmental monitoring products. One new company, Isensix, has released a product that uses wireless devices to transmit and monitor temperature and humidity. The wireless remote monitoring system includes a variety of alarm notification methodologies, such as e-mail, pager, and mobile phone contact. "The Isensix product provides a cost-effective early warning system to avoid catastrophic events," said William Son, president of Isensix. The company did not disclose pricing for the product.

Other vendors that offer similar solutions include Mack Systems Inc. and LabPro LLC. The cost of monitoring two to three refrigerators with these vendors’ products ranges from $2,000 to $3,000.

Several AABB exhibitors displayed hand-held positive patient identification devices. AMTSystems has six sites pilot testing its transfusion application. Precision Dynamics Corp. touted its radio frequency identification solution, which allows data to be read and updated in a patient’s wristband. Korchek Technologies demonstrated its new CareChek Tx product, which uses a pocket PC device and a portable bar-code printer to verify blood product administration, document vitals, and create documentation that meets AABB requirements. Bio-Logics Products Inc. showcased its all-in-one personal digital assistant, scanner, and bar-code printer. The company is still developing its blood bank transfusion module. United Kingdom-based Datalog International Ltd. has developed a complete transfusion service system, which is being used by the U.K. National Blood Service in the Oxford Radcliffe Hospitals. Datalog has entered into an agreement that allows Olympus Corp. to distribute the system in the United States and Canada.
�Hal Weiner

Atlas opens doors on public health division
Atlas Development Corp. recently established a new operating division, Atlas Public Health. At the core of the Atlas Public Health Information Network suite is Visual CMR, a system co-developed by Atlas and the Los Angeles County Department of Health Services to manage the investigative cycle of a disease outbreak from onset to final resolution. The Atlas PHIN suite combines Visual CMR’s electronic communicable disease incident tracking and case management with automated electronic laboratory reporting and Internet-based submission of incident reports from infection control practitioners and the wider health care provider community.

Atlas Public Health will employ tools and technology from its sister division, Atlas Medical Software, to link private sector laboratories to local and state public health departments, the company reports. Incident tracking and reporting capabilities also will be integrated with Atlas LabWorks, a software system that connects physicians to clinical laboratories for lab test ordering and reporting.

Atlas Development Corp.

SCC releases new version of SoftPath software
SCC Soft Computer has released an enhanced version of SoftPath, its pathology management software for anatomic pathology laboratories.

The new release provides expanded integration of Web software and an optional image-management module for maintaining image archives.

The software also offers Manager’s Dashboard, a feature that allows supervisors to assign and delegate work from a single environment, and My Workspace, a feature that allows users to access from their supervisors assignments that have been deposited in color-coded icon buckets.

SCC Soft Computer

BioLab Software offers new server for biotechnology data
BioLab Software Inc., a provider of bioinformatics software, has introduced the BioLab data server platform. The BioLab data server is an open source data-management software solution that allows researchers and labs to manage disparate data regardless of its format or origin. Users can collaborate securely via internal lab local area networks or the Web while managing the integrity of research data.

BioLab Software

Contracts
Misys Healthcare Systems has installed its Misys Laboratory and Misys Pharmacy products at West Valley Hospital Medical Center, a Vanguard Health System facility, Goodyear, Ariz.

Misys Healthcare Systems

Dr. Aller is director of bioterrorism preparedness and response for Los Angeles County Public Health Acute Communicable Diseases. He can be reached at raller@ladhs.org. Weiner is president of Weiner Consulting Services, LLC, Florence, Ore. He can be reached at hal@weinerconsulting.com. Dr. Weilert is director of laboratories, Community Hospitals of Central California, Fresno. He can be reached at mweilertmd@communitymedical.org.