National Lab Standards Coming For Patient Safety

CDC incubates lab Quality Institute to develop a national report and standards for lab safety

CEO SUMMARY: Because lab test data plays such an important role in medical decision-making, the Centers for Disease Control and Prevention (CDC) has launched a national effort to evaluate the quality of clinical and public health laboratories. In forming a Quality Institute, the goal is to issue a National Report on the Quality of Laboratory Services and develop quality indicators and guidelines that reflect best practices.

INITIAL STEPS HAVE BEEN TAKEN at the Centers for Disease Control and Prevention (CDC) to develop the first-ever national report on patient safety in clinical and public health laboratories.

The CDC, in partnership with 40 other organizations, held a Quality Institute (QI) Conference to pursue three objectives. One, to develop the framework and content for a National Report on the Quality of Laboratory Services. Two, to identify criteria for indicators that measure the quality of laboratory services. Three, to create an ongoing system that would collect and analyze data related to the quality of laboratory services in the United States.

This project can potentially affect lab testing services in significant ways. For that reason, laboratory administrators and pathologists should track the progress of the CDC’s laboratory Quality Institute as it goes about its work.

During the April conference, participants discussed the concept of forming a Quality Institute. Stake- holders representing the interests of laboratory professionals, industry representatives, clinicians, patient advocates, legislators, healthcare administrators, and accrediting organizations were present. The meeting’s objective was to provide the CDC with input and insights from all stakeholders and establish a task force to pursue the formation of the Quality Institute and achieve its three primary goals.

Several weeks later, on May 6-7 at the Executive War College in New Orleans, attendees were first to learn about the outcomes of the QI Conference. They were also briefed on the first draft of plans to develop a national report on quality of laboratory services, as well as monitors that would regularly measure the patient safety of laboratories in the United States.

Reducing Medical Errors

“Medical errors are the eighth leading cause of death in the United States,” stated Ana K. Stankovic, M.D., Ph.D., Co- Chair of the 2003 QI Conference in Atlanta. “Laboratories can play a major role in the effort to reduce these errors.

“Each year, more than 7 billion laboratory tests are performed in the United States,” she continued. “The results of these lab tests influence about 70% of medical decisions. Activities of the Quality Institute could help identify ways that laboratories can contribute to a reduction in medical errors and ongoing improvements in patient care.”

Stankovic is passionate about quality in the laboratory. At the time of the Atlanta QI Conference and the Executive War College, she was a member of the CDC’s Division of Public Health Practice Program Office. She recently accepted a position at Becton Dickinson as its Worldwide Medical Director for Pre-analytical Solutions, but continues with her role on the Executive Committee of the CDC’s Quality Institute.

Patient Safety Priorities

“Patient safety is now a major initiative across all sectors of the American healthcare system,” said Stankovic. “The Institute of Medicine’s (IOM) 1999 report on medical errors determined that between 45,000 to 98,000 people per year die in hospitals as a result of medical errors. This is a staggering statistic and does not include errors that affect outpatients!

“Besides the tragic impact on individual lives, it is estimated that costs associated with preventable medical errors in hospitals total as much as $17 billion annually. That number is even higher if we include medical errors that occur to outpatients.”

Stankovic observed that laboratories themselves are the source of some medical errors. It is the goal of the Quality Institute to identify sources of medical errors in laboratory testing services, then develop ways to reduce and eliminate such errors.

“Several studies on errors in the laboratory demonstrate the problem and the opportunity,” said Stankovic. “For example, Bonini,, wrote an excellent article, “Errors in Laboratory Medicine,” (Clinical Chemistry 2002, 48:691-8). The authors stated that about 12.5% of laboratory errors have some affect on patient health. It was also noted that, when an adverse patient event occurs, it is usually a combination of defects on multiple levels.”

Labs Do Make Errors

“Studies conducted by the CDC and others show that laboratory errors occur in 34-per-100,000 patient events and 1-in-8,300 laboratory results,” she added. “Either way, these numbers are not good. If we compare these numbers with what should be achieved in a Six Sigma laboratory, we see a significant difference.

“Most laboratories currently perform in the three to four Sigma range, which is 93.3% to 99.4% accuracy,” she continued. “This performance is not as good as it appears, because it equates to 6,210 errors per million test results, which is unacceptable. Compare this to a laboratory operating at five Sigma quality, which is 99.98% accuracy, or 233 errors per million tests performed. A six Sigma laboratory performs at 99.99%, or 3.4 errors per million tests.

“At the 2003 Quality Institute Conference, we spoke about dividing the total laboratory testing process into five major phases for study,” noted Stankovic. “These phases are pre-pre-analytical, pre-analytical, analytical, post-analytical, and post-post-analytical.

“Initial studies indicate that most laboratories are doing well in the analytical phase, but there is a lot of work to be done in the other phases,” she explained. “Two areas that have traditionally received the least attention by lab directors and those involved in the healthcare system are the pre-pre-analytical phase, which is selecting the right test for a particular clinical scenario, and the post-post-analytical phase, which relates to the use of lab results by clinicians. Everyone in the healthcare system must do more in these areas if they are to make a greater contribution to patient safety and improved healthcare outcomes.”

Defining the correct tests for patient diagnoses and interpreting complex results has become more important in such areas as coagulation, genomics, and proteomics. Stankovic observed that clinicians cannot keep up with the explosion of new laboratory tests. Pathologists and clinical laboratory scientists need to provide more guidance and support to aid physicians in the care they provide patients.

Quality Institute Committee Plans To Launch National Lab Quality Awards

WITHIN ANOTHER YEAR OR SO, the laboratory industry may see the Steering Committee for the Quality Institute announce the first national laboratory quality awards recognizing innovative practices.

“To make national awards in laboratory quality a reality, we need to first develop relevant criteria about attributes which contribute to quality, then develop indicators and measurements of laboratory quality and overall patient safety,” stated Ana K. Stankovic, M.D., Ph.D., co-chair of the CDC’s Quality Institute Conference. “This fall, a team will be formed to pursue this goal. I was selected to lead this team.

“Two other teams will be the quality indicators team, led by Lee Hilborne, M.D., Associate Professor of Pathology at the University of California at Los Angeles. It will look into defining a set of core quality indicators,” noted Stankovic. “The other team is the sentinel laboratory team, led by Michael Noble, Ph.D., Associate Director, Department of Pathology and Laboratory Medicine, University of British Columbia. Wherever possible, we want to use existing networks and laboratory quality indicators.

“We will meet in September to begin developing this information and identifying relevant indicators of laboratory quality,” she added. “The challenge is to develop deliverables that add value to both laboratories and the healthcare system itself, without creating unnecessary burdens.”

Work on this project and the awards will proceed rapidly. “At this stage, we are still in the planning stages of the awards process; everything is going to be much clearer in September,” observed Stankovic. “Once the criteria for the award selection is determined, the team will then identify candidates who have made contributions to improving laboratory quality. Our plan is to recognize these individuals and entities, then distribute the awards at the Institute Conference in the fall of 2004.

Labs Should Expand Role

“Collectively, laboratories generally do not have an effective way to allow interaction with clinicians and receive feedback after laboratory test results are reported,” she noted. “Too often laboratory test reports simply provide a number or are too verbose, making it tough for clinicians to clearly under- stand the results of the tests and their relevance to the patient’s condition.

“For example, a lab test report may identify and name an antibody, like Anti-Kell. But the report will often fail to mention that the presence of this antibody can cause hemolytic disease of the newborn, which represents the most relevant clinical information,” explained Stankovic. “The laboratory needs to contribute more to the care of the patient. The [lab’s] knowledge is there, it just does not appear on the chart. As another example, how much more valuable would lab test data be if a representative from the laboratory was present when rounds are conducted?

“Having said this, I’d also like to point out that the laboratory profession is much further ahead of other clinical specialties, particularly in the analytical phase,” she added. “There is licensing, proficiency testing, certification, accreditation bodies, regulatory oversight (CLIA 88), quality assurance, and quality control. But we still have a long way to go.”

“As another example, how much more valuable would lab test data be if a representative from the laboratory was present when rounds are conducted?”

Stankovic next addressed the work of the Steering Committee for the QI. “At the April meeting, we started with 40 partners,” she said, “including healthcare providers, payers, insurers, policy makers, professional organizations in both the laboratory and diagnostic industries, government, patient advocates, and independent laboratories.

“The purpose of that three-day meeting in April was to bring people together, look at the issues, and develop a realistic vision,” stated Stankovic. “Eight work groups were formed to focus on three different topics. Three of these groups were primarily focused on assessing the need for development of a National Report on Laboratory Quality. They discussed, in broad terms, its format and content. Primary hurdles in this effort are cost and legal issues.”

Lab Quality Measures

“Three work groups spent time at the meeting discussing the need for reliable quality indicators of laboratory services, such as access to health care, timeliness, and appropriate use of laboratory tests,” noted Stankovic. “These groups will have to work through many questions regarding participation, reporting, access to data, privacy, tracking, and confidentiality, just to name a few.

“The remaining two groups concentrated on the need for an ongoing Quality Institute,” she added. “So far, these two groups have agreed that the mission of the QI should be in surveillance of laboratory services and as a resource to the laboratory profession. It should also educate public payers about the value of laboratory testing services and act as a data clearing house on laboratory services, both for the laboratory profession and the healthcare industry in general.”

The reason for the conference and its goals are described in the QI Conference White Paper: “An Approach to Medical Errors and Patient Safety in Laboratory Services.” (Go to It was developed by Marc Silverstein, M.D., who is also a member of the Executive Committee for the QI.

With the CDC facilitating a national effort to improve the laboratory’s contribution to patient safety, THE DARK REPORT predicts that the resulting monitors will reinforce the need for labs to shift their management emphasis toward outcomes that meet the expectations of clinicians and patients.


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