American Association for Clinical Chemistry
Better health through laboratory medicine
February 2007 Clinical Laboratory News: Washington Profiles

February 2007: Volume 33, Number 2

LSI Releases Three Guidelines
The Clinical and Laboratory Standards Institute (CLSI) recently published three new documents: Managing and Validating Laboratory Information Systems (AUTO 8-A), Autoverification of Test Results (AUTO 10-A), and IT Security of In Vitro Diagnostic Instrumentation and Software Systems (AUTO 11-A). The first guideline (AUTO 8-A) is intended to provide guidance for developing a validation protocol for the laboratory information system (LIS), as well as protocols for assessing the dependability of the LIS when storing, retrieving, and transmitting data. It's designed to address the validation of the LIS, as well as any interface to external systems, which include electronic health record systems, point of care devices, and instrumentation. Validation ensures that information is accurate and reliable during sample accessioning, transmittal of test results, and throughout the system's intended use. The autoverification document (AUTO 10-A) provides guidance on design, implementation, validation, and rules customization, as well as regulatory compliance and algorithm validation. Standards detailed in the guidance provide assistance on developing autoverification methods specific to patient populations. The IT security document (AUTO 11-A) provides a framework for communicating between IVD system vendors and health care organizations regarding the security of these systems. The document reviews real and potential threats; technical, process, and operational requirements; implementation procedures; and recommendations regarding the use of the standards. Information on ordering these guidelines is available on CLSI's Web site.
Congress Passes NIH Reform Bill 
Late last year, the House and Senate completed work on the National Institutes of Health Reform Act of 2006 (H.R. 6164), which reauthorizes—as well as reorganizes—the research center. This legislation increases NIH's spending authority by at least 7% over the next few years, provides incentives for the agency's institutes to collaborate on research projects, and creates a review board to recommend organizational improvements. Sen. Edward Kennedy (D, Mass.) backed the legislation, asserting that it's critical for the U.S. to continue investing in medical research. At press time, the legislation was at the White House for review. If the Administration approves the bill, it becomes law, although Congress will still need to appropriate the necessary funds to make the budget increase a reality. Additional information on the legislation is available on THOMAS, the congressional Web site.
CMS Announces 2007 Clinical Lab Fee Schedule
In early December, CMS released this year's Medicare Part B lab fee schedule, which provides a zero update to comply with the 5-year freeze on updates that was implemented in 2003, according to the National Intelligence Report (Dec. 15, 2006). There are 11 new CPT test codes on this year's schedule for conditions such as liver cancer, heart disease, West Nile virus, and staphylococcus. Additional information, including payment amounts, is available on the CMS Web site.
Health Appropriation Bill Postponed
Before the 109th Congress adjourned, the House and Senate were unable to reach agreement on the remaining nine of 11 fiscal year (FY) 2007 appropriations bills, including legislation funding federal health programs. Republican leaders passed a continuing resolution funding federal programs through mid-February at 2006 levels, which means that funding decisions will be made by the incoming Democratic leaders. But Democrats appear inclined to extend the continuing resolution until the end of September, instead focusing on the 2008 budget cycle, especially since President Bush is expected to release his FY08 budget this month. In order for federally funded health and science programs to get any scheduled increases, Congress will need to make adjustments to the continuing resolutions.
Bush Boosts Biodefense Funding
On December 19, 2006, President Bush signed the Pandemic and All-Hazards Preparedness Act (S. 3678) into law, providing new federal funds to assist state and local governments in preparing for terrorist attacks or natural disasters. The measure also provides grants to hospitals, clinical laboratories, and universities for ‘real-time disease detection improvement'. In addition, the legislation recommends that the National Science Advisory Board for Biosecurity, when requested by HHS, provide guidance on a core curriculum and training requirements for workers in maximum containment biological laboratories, as well as periodic evaluations of biological laboratory capacity. Additional information on the legislation is available on THOMAS.