American Association for Clinical Chemistry
Better health through laboratory medicine
July 2008 Clinical Laboratory News: Regulatory Profiles

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July 2008: Volume 34, Number 7


Long-Awaited CDC Draft Report on the Status of Lab Medicine Published


After months of anticipation, a draft of Laboratory Medicine: A National Status Report is available for viewing. CDC accepted comments on the draft until June 23 and will consider them for inclusion in the final draft, expected to be posted by the end of July.

The report is one part of a three-task project shepherded by the CDC to enhance the practice of laboratory medicine by identifying ways to improve laboratory testing and services. The other related tasks and accompanying reports involved developing a process to define, identify, categorize, and evaluate best practices and policies in laboratory medicine and the settings in which they apply; and evaluating the effectiveness of U.S. proficiency testing programs to meet quality improvement, educational, and regulatory goals for clinical laboratories (see CLN, June 2008).

Written by The Lewin Group, under subcontract to Battelle Memorial Institute, the report examines key factors affecting laboratory medicine. It includes a detailed profile of the laboratory medicine sector and discusses such topics as current standards for laboratory testing and services, regulatory oversight including CLIA, impact of accreditation, reimbursement policies, performance measurement, quality improvement, evidence-based decision making, and trends affecting the field.

According to the report, laboratory services account for only 2.3% of total U.S. healthcare expenditures and 2% of Medicare expenditures, but they play a significant role in informing healthcare decisions and spending. Appropriate use of laboratory testing is essential for achieving safe, effective, and efficient patient care. The draft report is available online.


AACC Calls On Laboratorians to Support The National Children’s Study


The Children’s Health Act of 2000 authorized the National Institute of Child Health and Human Development, as well as the National Institute of Environmental Health Sciences, the CDC, and the U.S. Environmental Protection Agency, to conduct the National Children’s Study (NCS). This initiative will examine environmental influences on the health and development of over 100,000 children through infancy, childhood, and early adulthood. But this study is contingent on Congress’s providing the $192.5 million needed to keep the National Children’s Study moving forward. Unfortunately, the budget proposal President Bush submitted to Congress for FY 2009 did not provide funding for the study.

AACC has endorsed the study, and the Pediatric Reference Range Committee (PRRC) is working with the scientists leading the study, advising them on laboratory-related issues such as how to collect and store samples and how to analyze them. The PRRC hopes to use the data gathered from the study to develop pediatric reference ranges. The PRRC also is planning to conduct a series of adjunct studies, in conjunction with the NIH initiative, to consider key analytes not taken up by NCS. 

AACC urges all laboratorians to contact their legislators via AACC’s online advocacy center on the AACC Web site, to encourage them to support this important study.


National Quality Forum Endorses Consensus Standards


The National Quality Forum (NQF) has endorsed 48 voluntary consensus standards focused on measuring the performance of acute care hospitals. NQF anticipates that these measures will facilitate broad-based quality improvement within hospitals and will help track progress toward improved patient safety.

Six of the measures target venous thromboembolism (VTE), a leading cause of illness and death in the U.S. One of these measures involves laboratory assessment of VTE patients with anticoagulation overlap therapy, and another focuses on unfractionated heparin dosages/platelet count monitoring.

NQF has categorized other measures as Length of Stay/Readmission, Adult Patient Safety, Pediatric Patient Safety, Pediatrics, and Surgery and Anesthesia. The entire list of measures is available online.


RWJF Commits $300 Million to Tackle Disparities


The Robert Wood Johnson Foundation (RWJF) recently announced a 3-year, $300 million initiative intended to narrow healthcare disparities across lines of race and geography. Officials said it would be the largest effort to improve healthcare quality ever undertaken by a charity in the U.S. The initiative, focusing on communities in 14 geographic areas that together account for 11% of the population, will bring together practices, hospitals, health plans, and patients to work on ways to improve the quality of care across different settings.

The RWJF also released new research—conducted by the Dartmouth Atlas Project at the Dartmouth Institute for Health Policy and Clinical Practice—that analyzes Medicare claims to illustrate variations in healthcare quality nationwide. One finding of the new study was that an estimated one in seven patients with diabetes does not get crucial blood tests, such as HbA1c. About 85% of white patients with diabetes received these tests, compared with 79% of African Americans. In Alaska, 71% of patients with diabetes received blood sugar control tests every year, compared with the national average of 91%. To access more information about the initiative, go to Robert Wood Johnson Foundation website.


Federal Grants for School Drug Testing


The White House Office of National Drug Control Policy and the U.S. Dept. of Education awarded federal grants for school-based random student drug testing totaling $5.8 million to 50 educational entities in 20 states. It is the fifth such grant award announcement since 2003.

States in which the grants were awarded are: Alabama, Arizona, California, Colorado, Florida, Illinois, Indiana, Kentucky, Louisiana, Michigan, Mississippi, Nevada, New Jersey, North Carolina, Ohio, Oklahoma, Pennsylvania, Texas, Utah, and Washington. Grant amounts range from $38,860, given to Currituck County Schools in North Carolina, to $228,569, given to Premier Integrity Solutions, a drug and alcohol testing company headquartered in Russell Springs, Kentucky.

More than $40 million in federal grants have gone to an estimated 140 education and health entities since 2003 to develop, implement, or expand random student drug testing. The U.S. Supreme Court upheld the constitutionality of school-based random student drug testing in 1995 and 2002.