College of American Pathologists
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  Best practices for labs? CDC hunts for answers






May 2007
Feature Story

Karen Lusky

The quest to identify what works best in laboratory medicine is moving forward with a Centers for Disease Control and Prevention project set to wrap up with findings and recommendations this fall. The project, “Defining Best Practices in Laboratory Medicine,” lays the groundwork for enhancing the quality of laboratory services, which is like fine-tuning the steering mechanism for much of what’s done in health care.

“Considering the number of diagnostic and therapeutic health care decisions made every day based on laboratory studies, any efforts to improve their quality has a major impact on patient care,” says E. Randy Eckert, MD, chair of the CAP Council on Government and Professional Affairs. Reports are expected this September from the CDC best practices project, which was launched in October 2006 through a contract with Battelle Memorial Institute, Columbus, Ohio. The CDC is, however, exploring ways to continue the work beyond then, says Julie Taylor, PhD, technical monitor for the project and acting chief of the CDC Laboratory Practice Evaluation and Genomics Branch.

The best practices project comprises three tasks:

  • Develop a report on the current state of laboratory medicine.
  • Develop a process that defines, identifies, categorizes, and evaluates best practices and policies in laboratory medicine.
  • Evaluate the effectiveness of proficiency testing programs to meet quality improvement, educational, and regulatory goals for clinical laboratories.

Dr. Taylor says the CDC will share work products from each of these tasks with the laboratory medicine community and weigh suggestions and comments before publishing reports on the findings.

The first task—the report on lab medicine—will discuss trends, regulatory oversight, impact of accreditation, reimbursement policies, performance measurement, and more. The CDC envisions the deliberations on proficiency testing—task No. 3—as the start of a process that will lead to stronger PT programs. And it is a group of clinicians, pathologists, laboratory scientists, and others that is tackling the best practices task. But don't expect the group to hand over a list of vetted best practices come September.

That’s because the CDC workgroup will not identify best practices but will develop the process by which to identify them, Dr. Taylor says. The process will be developed to encompass practices in the total testing cycle, including those related to communication between the laboratory and clinicians, and tested using a limited proof-of-concept study.

As a model for how to develop the process, the workgroup is considering the approaches used by multiple organizations, including the U.S. Preventive Services Task Force. The latter takes an evidence-based approach to guideline development, using a panel of experts to select topics and review the evidence, Dr. Taylor explains. “The experts translate evidence into recommended guidelines,” she says.

The goal is to eventually identify actual best practices, though it may not be the CDC that does it. It may be a forum organized with input from the laboratory community, as well as from other stakeholders including health care systems, payers, patients, and policymakers, she says.

The workgroup charged with the proficiency testing task, of which George Fiedler, CAP vice president and general manager for proficiency testing, is a member, will discuss potential changes to current PT programs in the U.S. (Also in the workgroup are CAP members George S. Cembrowski, MD, PhD, of the University of Alberta, Edmonton, and James Winkelman, MD, former clinical lab director at Brigham and Women’s Hospital and professor emeritus, Harvard School of Medicine, Boston.)

The group will ask two questions: What is working well, and where could improvements be made? “We will take into account stakeholder input and develop recommendations for improving the effectiveness of PT,” Dr. Taylor says.

The best practices and proficiency testing workgroups have ex-officio members from the Centers for Medicare and Medicaid Services and the Food and Drug Administration.

Judy Yost, MA, MT(ASCP), director of the CMS Division of Laboratory Services, tells CAP TODAY that if the PT workgroup makes recommendations with regard to the current PT regulations or policies, the CMS will take them into consideration. She notes that the PT regulations haven’t changed since 1992. “So the timing is good for us to take a look at things because now we have experience with the requirements and know what works and what doesn’t.”

For example: Are the analytes used for PT appropriate? Do they need to be enhanced, changed, or deleted? Are the target values for grading PT appropriate? Are there other approaches to consider for PT? As an example of the latter, for genetic testing, two labs could do reciprocal testing in which they split a specimen, test it, and compare their results, Yost says.

“Certainly we aren’t jumping to do another regulation,” Yost adds, “but it’s something we would consider at some point. It’s on our list to see where we need to update requirements for PT because the technology and environment where testing is performed has changed over time.”

As part of its agenda for enhancing laboratory services, the CDC will also host the 2007 Institute on Critical Issues in Health Laboratory Practice: Managing for Better Health, which is the fifth in a series on critical issues and will take place in Atlanta Sept. 23–26. Information from the three tasks of the best practices project will be presented there.

Attendance at the institute will be by invitation, but the plenary presentation will be Webcast. Topics on the agenda are management systems, informatics, technology, integrated lab services, and customer expectations.

The vision for the institute is “laboratory services integrated with the health care system to make sure the right test analyzed by the best method is performed on the right person at the right time—and the right information is reported at the right time to the right people,” says institute steering committee member Ana K. Stankovic, MD, PhD, MSPH, worldwide vice president of medical and clinical affairs for BD Diagnostics, Preanalytical Systems, and a member of the CAP’s Quality Practices Committee.

The CDC best practices project builds on the work previously done by the Institute for Quality in Laboratory Medicine, or IQLM, says Lee H. Hilborne, MD, MPH, professor of pathology and laboratory medicine in the David Geffen School of Medicine at the University of California at Los Angeles. Dr. Hilborne served as indicator workgroup co-chair of the IQLM, a public-private partnership with more than 65 stakeholders, including the CAP, and is now a member of the best practices workgroup for the CDC best practices project. (Other CAP members in the workgroup are Joan Barenfanger, MD, PhD, of Memorial Medical Center, Springfield, Ill.; Michael Laposata, MD, PhD, of Massachusetts General Hospital; and Stephen Raab, MD, of the University of Pittsburgh School of Medicine.)

In April 2005, the IQLM unveiled 12 candidate quality measures to evaluate further, but lack of funding later halted the effort. The measures encompassed the spectrum of testing, from preanalytical to postanalytical. There is a key difference, however, between the work of the IQLM and the CDC’s current project: The latter focuses on laboratory practices, not performance measures.

Preferred practices are the focus, too, of a CDC-funded study the CAP is spearheading on patient specimen misidentification. Paul Valenstein, MD, CAP co-investigator for the study and chair of the CAP Quality Practices Committee, says the study is taking a new approach to the all-too-common problem.

“The CAP and CDC are attempting to better define the business case for addressing the specimen identification problem,” Dr. Valenstein explains. “We believe that if decisionmakers have a better understanding of the expenses associated with specimen ID errors, hospitals, physician offices, and laboratories will be more likely to invest in the infrastructure required to prevent misidentification of specimens.”

To investigate the problem, the researchers identified several care scenarios in which specimens might be misidentified. They then assembled a focus group of caregivers and asked them to comment on what actions they would take in response to particular test results in each scenario. This way, the economic and clinical consequences of identification errors become more clear, Dr. Valenstein says.

The study is expected to be completed this August.

One question on many minds is whether the CDC’s efforts to help identify best practices for laboratory medicine pave the road for eventual Medicare pay for performance for laboratory services.

Dr. Hilborne says the agency’s goal is not to create metrics that would be used specifically for pay for performance—just as that was not the intent of IQLM’s previous work. “The CDC’s desire is to identify preferred or best practices that are evidence-based and encourage the laboratory community to broadly adopt them,” Dr. Hilborne says.

As the best practices become evident, they could also have an impact in the regulatory arena.

CMS’ Yost says, “If we find there are practices or indicators of performance that would help us do our job better, and help the labs do a better job, we would certainly consider them.” Yost says the CMS would work with its partners in lab oversight, including CMS regional offices, accreditation agencies, and CLIA-exempt states, to decide how to make the best use of the best practices.

Karen Lusky is a writer in Brentwood, Tenn.