June 30 , 2005

In This Issue . . .

Measuring Lab Testing Quality: What Indicators Make Sense?
By Julie McDowell

Improving health care quality is moving out of rhetoric and into action, federal officials emphasized at April’s Institute for Quality Laboratory Management (IQLM) meeting held in Atlanta, Ga. Formed by the Centers for Disease Control and Prevention (CDC) in 2003, IQLM is positioning itself as the leader in defining lab-related quality improvement benchmarks by gathering input from key stakeholders in the clinical laboratory community, including professionals from commercial, hospital, and physician-office labs, along with manufacturers and government officials. One of IQLM’s initial tasks was to identify a core set of indicators that would help labs assess quality throughout the total testing process and cover a wide range of clinical settings. This month, Strategies looks at a preliminary set of indicators presented at April’s meeting, as well as what impact quality assessment could have on laboratories, especially if pay-for-performance reimbursement structures become a reality.

With the U.S. health care industry under pressure to improve patient care and reduce medical errors, laboratory quality is coming under increased scrutiny because of the prominent role clinical tests play in diagnosing and monitoring many disease states. “In no other specialty is there the opportunity to touch so many clinical situations that frequently impact patients,” said Lee Hilborne, MD, MPH, Professor of Pathology and Laboratory Medicine, David Geffen School of Medicine, University of California (Los Angeles), and co-leader of IQLM’s Quality Indicators Workgroup. Hilborne, who is also the Director of UCLA’s Center for Patient Safety and Quality, was a presenter at the April meeting.

After surveying quality measures published by various organizations—including the Joint Commission on Accreditation of Healthcare Organizations, National Committee for Quality Assurance, Agency for Healthcare Research and Quality, and the College of American Pathologists—Hilborne’s group came up with 12 indicators, categorized by testing phase (see Box). 

• Patient identification
• Test order accuracy
• Blood culture contamination
• Adequacy of specimen information
• Diabetes monitoring
• Hyperlipidemia screening Analytic
• Accuracy of Point-of-Care Testing
• Cervical Cytology/Biopsy Correlation
• Critical value reporting
• Turnaround time (infrastructure)
• Clinician satisfaction (infrastructure)
• Clinician follow up (system/general)

Courtesy of IQLM Quality Indicators Workgroup

These indicators could serve as a universal standard for monitoring quality in the lab, explained Hilborne. They are also an integral part of the IQLM’s overall mission (see right). Such indicators will inform a proposed laboratory national report that would be published by IQLM, he said, adding that there will be awards and incentives for quality performance for members of the IQLM Network, which is a nationwide system of clinical laboratories and their partners.

However, these are proposed measures, and are likely to be revised based on feedback from the lab community. For example, quality of the analytic phase will likely get more attention in the future, according to Hilborne. “While we [the Quality Indicators Workgroup] all agree that all phases of the total testing process are in fact important, we are focusing quite a bit on the analytic phase,” he said. “We concluded that as we move forward with indicators, it will be particularly important to shine the light on the pre- and post-analytic phases because those are the areas that will have the most impact.”

Indicators in a Pay-for-Performance Environment

While recognition and financial incentives might motivate more labs to focus on meeting quality improvement benchmarks, the government’s interest in pay-for-performance (P4P) systems might make these measures more mandatory—and less of an option—if a lab’s reimbursement payments depend on how well they measure up to quality indicators compared to other facilities nationwide. Currently, the Centers for Medicare & Medicaid Services (CMS) are involved in numerous P4P demonstration projects, including the Hospital Quality Alliance, the Premier Hospital Quality Incentive, and the Physician Group Practice Demonstrations. Because IQLM was launched by a government agency—the CDC—and the 12 indicators were determined based on input from stakeholders from various regions of the clinical laboratory world, federal health officials, including CMS, are bound to take notice and could use these proposed indicators to guide future policy.

In a P4P environment, labs might be forced to look beyond their boundaries to ensure quality, warned Frederick A. Meier, MD, a co-leader of the Quality Indicators Workgroup and Division Head, System Laboratories, Dept. of Pathology and Lab Medicine, Henry Ford Health System (Detroit, Mich.), at the April meeting. “If you are going to be rated on blood culture contamination rates, then somebody who cares about contamination and knows how to reduce its likelihood needs to collect blood culture specimens,” he said. “Also, if pre-preanalytic system monitors, like diabetes monitoring and hyperlipidemia screening, and a post-postanalytic system measures, like clinician follow-up, make it into the set of laboratory quality indicators, on which lab P4P will be assessed, this extension will cause a re-structuring of laboratorians’ responsibilities, stretching them into these domains.”

If P4P appears effective at improving patient care, then it’s possible that whatever indicators IQLM ultimately identifies could be incorporated into some type of program, said Hilborne. However, he has some concerns about P4P programs. For example, for some patients, clinicians may not be able to meet the requirements for the indicators, yet the abstraction process would still require that they be scored against the requirements. In addition, the requirements may not allow clinicians to provide tailored, appropriate care for patients that depend on their clinical situations, and patient preferences may not be considered if they are inconsistent with the P4P guidelines.

“Right now our efforts are not focused particularly on pay-for-performance, although we certainly hear that if you shine a light on efforts and you pay for this effort, that’s where you will get improvement,” said Hilborne. “But right now, our efforts are focused on testing and making sure these [indicators] are valid and getting the [lab] community collectively to start to raise the bar. Whatever indicators down the road might be incorporated in a pay for performance activity remains to be seen.”

For more information:
• Visit the IQLM Web site (
www.iqlm.org) for more information about the meeting, including the additional Workgroup publications and presentations.
• The July 2005 issue of Clinical Laboratory News will explore the relationship between pay-for-performance and clinical labs.
• Descriptions of all the CMS pay-for-performance demonstration projects can be found online at http://www.cms.hhs.gov/quality.

Julie McDowell is the Editor of Strategies. She can be reached by email.
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