News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Microgripper Can Harvest “Microbiopsies” Via Minimally Invasive Surgery

Pathologists may eventually have a new tool that makes it possible to collect microbiopsies using minimally-invasive surgery. The invention is a product of research at Johns Hopkins University and uses biochemicals to operate the device. A tiny handlike gripper is 500 micrometers (0.05 centimeters) in diameter, and made of a film of copper and chromium covered with polymer. Scientists say the gripper can grasp tissue or cell samples inside the body.

As a proof of concept, researchers used the device to perform an in vitro biopsy on a cow’s bladder. The technology also might work in clinical labs, the researchers said. The device can be moved remotely by using a magnet. It has “fingers” that will close around the target object in response to chemical triggers.

An article in MIT’s Technology Review explained how it works. The gripper remains open if the polymer stays rigid. Researchers can activate the gripper’s fingers to make them curl inward to form a ball that is 190 micrometers wide by adding a chemical trigger or lowering the temperature, thus softening the polymer. Adding a second chemical sends a signal to reopen the gripper. The chemicals used as triggers are harmless to humans.

For clinical labs, these microgrippers could be used for lab-on-a-chip applications, the article said. The microgrippers could move samples around a chip or clean debris. One drawback, however, is that using chemical triggers can make the device difficult to control. If the chemical environment changes, it can change how the device performs.

The lead researcher is David Gracias, Ph.D., a biomolecular- and chemical-engineering professor at Johns Hopkins University. During a meeting of the American Chemical Society earlier this year, Gracias and colleagues demonstrated how the microgripper could grasp and maneuver tiny beads and clumps of cells in a petri dish.

Researchers believe the technology is a step toward surgical tools that move freely inside the human body. The gripper would respond autonomously to chemical cues in the body, and could, for example, react to the biochemicals released by infected tissue. The microgripper could close around the tissue, so that doctors could remove the pieces for analysis, the article said.

“This is the first mobile micromachine that has been shown convincingly to do very useful things,” Gracias says. “And it does not require electric power for operation. We want to make mobile surgical tools. The ultimate goal is to have a machine that you can swallow, or inject small structures that move and can do things.”

Although introduction of this tool for microsurgery is likely to be years away, it is a demonstration of micro-technologies and nano-technologies that have the potential to give pathologists new capabilities. This invention is also consistent with the trend to perform laboratory tests with smaller specimens.

CMS Approves Norwegian Company for Hospital Accreditation in the U.S.

When it comes to hospital accreditation, the Centers for Medicare and Medicaid Services (CMS)  recently disrupted the status quo in at least three ways. First, last month it approved Norway-based Det Norske Veritas (DNV)  as a hospital accreditation program in the United States. Significantly, this is the first new hospital accreditation organization in the U.S. in 40 years.

Second, by taking this action, CMS is bringing the hospital industry closer to the use of ISO 9001 quality management systems. That’s because Det Norske Veritas, which already accredits hospitals in several countries worldwide, bases its accreditation process on use of ISO 9001. It has also created a program that combines the CMS “Conditions of Participation” with the ISO 9001 quality management system. DNV calls this program the “National Integrated Accreditation for Healthcare Organizations  (NIAHO).” At least 22 hospitals in the United States have already earned accreditation using NIAHO.

Third, by granting deeming status to DNV, CMS has introduced a new competitor for accreditation business into the U.S. marketplace-one that incorporates its accreditation standards on the ISO 9001 quality management system (QMS). Dark Daily predicts that it won’t take long for the Joint Commission to respond to this new competition by introducing an accreditation program that is also based on a quality management system like ISO 9001.

One U.S. hospital that has worked with Det Norske Veritas since 2005 is Newport Hospital in Newport, Rhode Island. During this time, the 120-bed community hospital has been surveyed four times by teams from DNV under its NIAHO program. Early in 2008, Newport Hospital was also surveyed by the Joint Commission and CMS, giving it a unique perspective on the similarities and differences from each of these survey programs. According to Terry McWilliams, Vice President of Medical Affairs at Newport Hospital, “They [Det Norske Veritas] consistently look for system-related issues and overall process improvement.” He further stated that the DNV survey, as conducted in his hospital was “clearly never inferior to our experience with any other agency-and at times superior! They really objectively look at your processes and how you might be able to improve them to get to that next level.”

For regular subscribers and readers of Dark Daily, these new developments are consistent with the healthcare trend of incorporating quality management systems, such as ISO 9001 and ISO 15189 Medical Laboratories, into the operation of healthcare organizations. It was in September that Dark Daily reported that the first two American laboratories were closing in on their ISO 15189:2007 accreditation. Piedmont Medical Laboratory (PML) of Winchester, Virginia, and Avera Health Laboratories of Sioux Falls, South Dakota, are in the process of completing the final steps required to earn accreditation under ISO 15189:2007. Each laboratory is using the College of American Pathologists (CAP) as its ISO 15189 accrediting body. (See “Two Labs in Friendly Race to Win First ISO 15189 Accreditation in U.S.“)

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