CDC Seeks to Identify Best Laboratory Practices

Two workgroups to formulate recommendations that could affect P4P and proficiency testing

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CEO SUMMARY: To advance the goal of enhancing the practice of laboratory medicine, the CDC has organized two teams of laboratory experts. They will study best practices and proficiency testing in medical labs nationwide. Such approaches as lab standards, voluntary reporting of adverse events, and adaptations of Six Sigma and Lean could help improve the quality of clinical laboratory testing. CDC aims to issue reports by September.

Over the next nine months, the federal Centers for Disease Control and Prevention (CDC) in Atlanta will undertake a project to define and identify best practices in laboratory medicine. The goal of the project is to enhance the practice of laboratory medicine by identifying ways to improve testing and services.

THE DARK REPORT believes that the CDC’s effort bears watching because it could result in the development of new approaches to quality for laboratories. Also, the program could be a step toward introducing pay for performance programs in laboratory medicine.

A Three-Step Process

The first steps in the project involve having a team of lab experts from across the country develop a process to define, identify, categorize, and evaluate best practices and policies in laboratory medicine. The second step is to evaluate the effectiveness of proficiency testing (PT) programs in the United States to meet quality improvement, educational, and regulatory goals for clinical laboratories. In the third step, the CDC will produce a report describing the current state of the field of laboratory medicine.

“Laboratory professionals and other stakeholders have expended considerable effort to provide safe and effective laboratory medicine services, but clinical laboratories share many of the same vulnerabilities that affect the overall health care system,” said Joe Boone, Ph.D, Associate Director for Science in CDC’s Division of Laboratory Systems.

“Medical labs already meet minimum quality requirements for laboratory testing and for the manufacture of safe and efficacious reagents and medical equipment in clinical laboratories,” observed Boone. “But nonregulatory approaches such as lab standards, participation in quality improvement programs, voluntary reporting of adverse events, and adaptation of methods such as Six Sigma and Lean have been used successfully in other fields and have improved the quality of clinical laboratory testing.”

The CDC created two teams to pursue this project. One team is the Workgroup on Process for Evaluating Best Practices in Laboratory Medicine. The other team is the Workgroup on Proficiency Testing.

Pay for Performance

Lee H. Hilborne, M.D., MPH, is a member of the workgroup that is developing a process to identify and evaluate best practices in lab medicine. A Professor of Pathology and Laboratory Medicine at the David Geffen School of Medicine at UCLA, Hilborne is President-Elect of the American Society for Clinical Pathology and he also is Deputy Director for Global Health at the RAND Corporation.

“The CDC’s efforts do not focus on increased regulation,” Hilborne said in an interview with THE DARK REPORT. “CDC is a public health entity, not a regulatory body. As evidence continues to emerge regarding strategies to optimize patient safety and quality, responsible organizations will incorporate these strategies into their operations as internal process improvement projects.

“There is a growing national movement to expand pay for performance (P4P) programs. CDC, like other leaders in the field, recognizes that these P4P efforts must be based on best practices,” Hilborne added. “Most best practices are process of care measures. Research is beginning to demonstrate practices where there is a clear and strong link between following the right processes and achieving good outcomes (which is ultimately what patients and providers want).

“If one wants to establish P4P initiatives, then they should demonstrate value,” Hilborne explained. “There’s no question that P4P will happen. The Centers for Medicare & Medicaid Services has already called for P4P for all disciplines. Defining appropriate P4P for laboratory medicine is more challenging than for many other specialties, but it is going to happen. The workgroup’s efforts should make a significant contribution toward defining the best evidence-based practices that the entire laboratory medicine community can accept.

“There are all kinds of processes that laboratories nationwide are using and once they’re reported widely, hopefully organizations would use them as inter- nal process improvement projects,” Hilborne said.

“What’s more, the CDC understands that all P4P efforts will need to be based on best practices,” Hilborne added. “My guess is that if you have a P4P effort and if you follow the right processes, you will produce good outcomes. That’s what research shows.

“If, in fact, you wanted to put in a P4P initiative, you will want it to be of value,” Hilborne explained.

Findings Reported

The CDC has contracted with the Battelle Memorial Institute in Columbus, Ohio, to manage the project. Battelle officials will disseminate the workgroups’ findings to organizations and individual lab practitioners. It also will gather suggestions and comments from lab practitioners. One challenge the workgroups face is developing a way to analyze best practices.

“Everyone involved with the endeavor recognizes that identifying and analyzing best practices are challenging tasks,” said Robert Black, a Senior Health Research Scientist with Battelle who is working with the CDC on the project. “But the objective is to begin nudging the field in the direction of evidence- based practice. Eventually that may mean using techniques that are analogous to clinical or community trials of laboratory practices to identify definitive evidence of the most effective practices. The ultimate goal of healthcare is to provide quality outcomes for patients and improve the efficiency of the whole sys- tem while also avoiding errors.

Goals For Lab Medicine

“Currently, the field of laboratory medicine appears to be quite a ways from being able to do that,” Black added. “The goal is start with the possible and work toward the desirable.

“This project is the continuation of the CDC’s efforts at promoting quality and encouraging collaboration among the various stakeholders in laboratory medicine,” Black explained. “The CDC has said it is interested in an approach that involves collaboration among the many stakeholders.

“We are keenly aware of the need to provide an opportunity for laboratory professionals to comment on the work as the workgroups proceed,” Black added. “We encourage communication among the workgroups and the various stakeholders. We will seek comments and ask stakeholders to review early work products and make suggestions.”

THE DARK REPORT observes that this new CDC initiative in laboratory medicine is designed to support “raising the bar” in the quality of laboratory testing and services delivered by laboratories in the United States. There is recognition by the workgroups that their findings are likely to influence laboratory pay for performance initiatives and proficiency testing programs in this country. Since the project involves identifying best practices, it is likely to have significant value for laboratorians.

CDC Plans September Report on Results

BY SEPTEMBER, THE FEDERAL CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) will issue a report on the key factors affecting quality in laboratory medicine.

The report will discuss current standards for laboratory testing and services; regulatory oversight (including the Clinical Laboratory Improvement Amendments (CLIA); the effect of accreditation; reimbursement policies; performance measurement; quality improvement; and evidence-based decision making.

The report is one of three phases of the project. Another phase involves identifying best practices. CDC has recruited a workgroup that includes experts in health services research, performance measurement, clinical practice, and lab management. The workgroups will develop a process to identify, categorize, and evaluate best practices, but will not formulate best practices.

The third phase involves the evaluation of proficiency testing (PT). A workgroup representing providers of PT, PT material suppliers, users of PT, and accrediting organizations will develop recommendations for assessing PT. The workgroup will want to know if PT helps improve the quality of laboratory testing, educates laboratory medicine practitioners, and meets CLIA’s regulatory goals.

CDC envisions the workgroup’s deliberations as the beginning of a process that will enhance the effectiveness of proficiency testing programs for medical labs in the United States.


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