October 2007 Clinical Laboratory News: Washington Profiles

October 2007: Volume 33, Number 10

CMS Seeks to Implement Specimen Date Policy

In mid-August, CMS posted Change Request 5573, which seeks to implement revisions to the date of service (DOS) policy for tests performed on laboratory specimens. These revisions were included in the final 2007 physician fee schedule regulation. In most circumstances outlined in the policy, the DOS of the test must be the date the specimen was collected; however, if a specimen is collected over a period that spans two calendar days, then the DOS must be the date the collection ended. In addition, CMS has outlined exceptions relating to DOS for tests performed on stored specimens and DOS for chemotherapy sensitivity tests performed on live tissue. This policy is set to be implemented January 1, 2008. For more information, including further details on the policy exceptions, a full copy of Change Request 5573 is available online.

Joint Commission to Test International Patient Safety Classification

The Joint Commission has been awarded a contract by the World Health Organization (WHO) to field test the International Classification for Patient Safety (ICPS). Sponsored by WHO’s World Alliance for Patient Safety, the goal of the project has been to create a classification system that optimizes the comparability of patient safety data and information across international borders. Together with an international panel of experts, The Joint Commission will coordinate the development of the classification system, which will be based upon the accrediting organization’s Patient Safety Event Taxonomy and draw from other international patient safety standards, including the National Patient Safety Agency’s National Reporting and Learning System in the United Kingdom. The Patient Safety Event Taxonomy has been endorsed by the National Quality Forum as the U.S. standard.

The ICPS is designed to define, harmonize, and group patient safety concepts into an internationally agreed upon classification that is conducive to learning and to improving patient safety across health systems. Plans for the system include translating patient safety data and information into a common terminology; facilitating the systematic collection of patient safety data and information; enabling data to be aggregated and compared; and providing a basis for international analysis. The Joint Commission’s field testing effort will determine the extent to which the ICPS reflects the realities and scope of patient safety worldwide, the feasibility of the program’s application across disparate healthcare settings, and produces valid and reliable results that can be used to enhance patient safety globally. The official version of the ICPS is expected to be available for global implementation in late 2008. Additional information is available online.

NHGRI Awards $30 Million in Genomic Science Grants

The NIH’s National Human Genome Research Institute (NHGRI) has awarded approximately $30 million to establish a new Center of Excellence in Genomic Science at the Dana-Farber Cancer Institute (DFCI) and to continue its support of an existing center at Stanford University.

Since 2001, the Centers of Excellence in Genomic Science program has brought together multi-institution, interdisciplinary teams to focus on making critical advances in genomic research. The new center at DFCI in Boston will receive about $16 million and the center at Stanford University in Stanford, Calif., will receive about $14 million. At Stanford, the Center for Excellence in Genomic Science led by David M. Kingsley, PhD, will continue the previous funding period’s work on using the stickleback fish as a model to explore the genomic mechanisms that have led to the diversity in the vertebrate group of animals. At the DFCI, the Center for Excellence in Genomic Science led by Marc Vidal, PhD, will test the hypothesis that both human genetic variations and pathogens, such as viruses, can influence cellular networks to cause disease. Working with viral infections as a model system, the DFCI researchers will investigate in a comprehensive manner how genetic and environmental disruptions in complex cellular networks interact to cause disease. Additional information about both these initiatives can be found on the NHGRI's Web site. 

CMS Halts Coverage for Hospital Errors

Beginning next year, hospitals will no longer receive higher payments for additional costs associated with treating patients for certain hospital-acquired infections and medical errors. Under these new rules, payment will be withheld from hospitals for care associated with eight conditions, including errors related to blood incompatibility, certain catheter-associated urinary tract infections, vascular catheter-associated infections, bed sores, and other conditions. According to the CDC, 2 million patients suffer from hospital infections every year and nearly 100,000 of them die.

As part of a 2005 law passed by Congress, CMS was required to evaluate a number of serious, preventable healthcare acquired conditions. The agency has identified these eight conditions for initial non-payment due to the high volume of patients affected, the high cost of treating patients, and the existence of prevention guidelines. CMS plans on considering other hospital acquired infections and medical errors for non-payment in the future.

These rules will go into effect in October 2008. A copy of these new CMS regulations is available on the CMS Web site.

Page Access: