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

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March 2008: Volume 34, Number 3

Joint Commission’s Draft Patient Safety Goals for 2009 Released

The Joint Commission has unveiled a preliminary version of its 2009 National Patient Safety Goals (NPSGs) for hospitals and critical access facilities, adding several new requirements and implementation expectations to its list of quality improvement priorities. First created in 2003 with assistance from an advisory group of patient safety experts and other medical professionals, the NPSGs aim to foster patient safety in accredited organizations. The goals are updated annually to ensure their ongoing relevance.

Two draft goals specifically address laboratory issues. As in previous years, the goal of improving the accuracy of patient identification relates to identifying patient blood samples. Newly added in the 2009 goals under Goal 1 is requirement 1A, involving the patient in the identification process, when possible, prior to any venipuncture, arterial puncture, or capillary blood collection procedure.

Also new, under Goal 3, is a requirement ensuring the accurate reporting of the INR for prothrombin time so that anticoagulant therapy levels are accurately monitored and adjusted. New implementation expectations under this requirement include: lab verification of the INR for prothrombin time calculation using the correct ISI specified by the manufacturer for each lot of thromboplastin reagent; updating the ISI each time there is a change in thromboplastin reagent lot number and prior to reporting patient results; and ensuring that the ISI value is applicable to the lab’s specific instrument model and software version, as identified by the manufacturer. 

Labs Sue to Stop Competitive Bidding Demo

Three San Diego, Calif. region labs have filed suit in federal court to stop the federal government from moving forward with CMS’s competitive bidding demonstration project in area. The suit was filed January 29 by Internist Laboratory of Oceanside, Sharp Healthcare of San Diego, and Scripps Healthcare of San Diego. The Clinical Laboratory Coalition, of which AACC is a member, announced its support for the lawsuit.

Sharp Healthcare and Scripps Healthcare contend that forced competitive bidding for lab services would have a negative impact on the integrated delivery of care. Internist Laboratory says the new rules would exclude it as a provider for Medicare beneficiaries, and force the lab to work with competitors to meet Medicare’s requirements.

The purpose of the project is to see if competitive bidding can be used to pay for Part B lab services at rates below the current lab fee schedule.

CAP Offers ISO Medical Lab Accreditation Program

A new program to accredit laboratories to conform with ISO 15189:2007 will be available to U.S. medical labs through CAP starting in the fall of 2008. The new program is separate and distinct from CAP’s Laboratory Accreditation Program.

ISO 15189:2007 is an accreditation program and quality management system that focuses on the continuum of care directly connected with improved patient safety and risk reduction. ISO 15189 also outlines standards for quality and competence particular to medical laboratories in developing their quality management systems and assessing their own competence.

For more information, go to

IOM Report Presents Plan to Assess Clinical Services Effectiveness

A new report from the Institute of Medicine offers a blueprint for a national program to assess the effectiveness of clinical services and to provide credible, unbiased information about what really works in healthcare. The report recommends that Congress direct the Department of Health & Human Services to establish a program with the authority, expertise, and necessary resources to set priorities for evaluating clinical services and to conduct systematic reviews of the evidence.

Although several organizations conduct evidence reviews and develop clinical practice guidelines, the report says that a single entity with the authority and resources is needed to determine what works and to end confusion. If established in a way that ensures transparency, scientific rigor, and high standards for accountability and objectivity, the proposed national program would be a trusted resource for reliable information on the effectiveness of health services, the report says. For additional information on this report, go to the Institute of Medicine Web site.

1000 Genomes Project Announced By International Consortium

In late January, an international research consortium announced the 1000 Genomes Project, an ambitious effort that will involve sequencing the genomes of at least 1,000 people from around the world to create the most detailed and medically useful picture to date of human genetic variation. The project will receive major support from the Wellcome Trust Sanger Institute in Hinxton, England, the Beijing Genomics Institute, Shenzhen (BGI Shenzhen) in China, and the National Human Genome Research Institute (NHGRI).

As with other major human genome reference projects, data from the 1000 Genomes Project will be made swiftly available to the worldwide scientific community through freely accessible public databases. The scientific goals of the 1000 Genomes Project are to produce a catalog of variants that are present at 1% or greater frequency in the human population across most of the genome and down to 0.5% or lower within genes. The individuals will be anonymous and will not have any medical information collected on them, because the project is developing a basic resource to provide information on genetic variation. The effort aims to develop a catalog of genetic sequences that researchers can use to study in many people with particular diseases.

To learn more about the 1000 Genomes Project go to their Web site.

WHO Launches Public Database to Track Bird Flu Information

The World Health Organization (WHO) has launched a public database of information to track strains of avian flu virus collected worldwide. The database is the result of nearly two years of debate over how and when to share samples of the bird flu virus that are thought to be critical to understanding the virus’s evolution, evaluating the risk of a pandemic, and developing vaccines.

The new database will track all the virus samples that countries have shared with WHO since November 2007. It also will list which vaccine companies or laboratories around the world receive them.

To visit the WHO database, go to WHO Web site.

Congress Requires Public Access to NIH-Funded Research

President Bush recently signed into law PL.110-161, the Consolidated Appropriations Act, 2008, which requires that scientific investigators who receive NIH funding make their published findings available to the public free-of-charge.  This provision replaces an early voluntary approach adopted by NIH in 2005. 

For more information on this new NIH policy, visit the NIH Web site