CHICAGO – In the opening plenary session of the 58th annual meeting of the American Association for Clinical Chemistry (AACC; Washington), “Harvey Fineberg, MD, PhD, president of the Institute of Medicine (IOM; Washington), said he “keenly” wanted to speak to the group. The reason: the workers in this industry are “under-appreciated,” he said, and there is “more to be done” to raise the profile and understanding of what laboratory scientists bring to healthcare, overall.

With his presentation, Fineberg clearly was carrying out the charter of the IOM, which dates back to the Civil War era, “to give advice to any branch of medicine that needs it,” he said.

And he offered two “basic strategies” for instituting key changes for labs: developing better technologies; and developing better ways to improve treatment using existing technologies.

“In the long run, new things” are always better, Fineberg said, but for short-term improvements, he advocated improving what is done for patients using existing technologies and know-how.

Not surprisingly, Fineberg referred to the IOM report titled “Crossing the Quality Chasm,” which outlined a blueprint to get from where the healthcare industry was in the late 20th century to where it needs to be in the 21st.

And as a reminder that there is still far to go, he also referred to the redundantly-cited report by the IOM released in late 1999, which detailed the number of errors made in the healthcare system and the estimated 98,000 who die in hospitals due to these errors.

Fineberg said that the blueprint laid out in the “Chasm” report determined that healthcare should be – first and foremost – safe. Following that, it should be effective, patient-centered, timely and efficient, while also being delivered equitably.

Unfortunately, more than 70 studies have documented poor quality of care in the U.S. and more than 30 studies have documented medication errors, he noted.

In one such study on the quality of healthcare delivered to adults in the U.S. with more than 6,700 participants, the study suggested that there are “substantial gaps” between the quality of care patients “deserve” compared to what they get, Fineberg said.

Using the model in clinical labs of four to five lab errors made per 10,000 tests, and 7 billion lab tests performed every year, that would mean anywhere from 3 million to 4.5 million lab test errors annually.

“If we have such a serious problem in quality and safety . . . how do we get our arms around it?” – and how should the U.S. decision-makers who could influence the quality of care “think about it?” Fineberg asked.

There are “alternative models to apprehend problems of safety and quality,” he said. These models include:

  • technology, and the belief that more advanced technology will solve quality problems;
  • the “morality” model, which holds that people with higher morals or personal responsibility should lead healthcare;
  • the “rational actor” model, which holds that healthcare providers are rational actors only and will respond to incentives (which, incidentally, would make a case for P4P, he said);
  • the “psychology” model, which says healthcare providers are just people in highly stressful situations and can only withstand so much within their limits.

Two other alternatives cited are that the healthcare system must rely on the educational system to produce the most highly qualified individuals and change must be implemented if that is not happening; and the systems model, whereby any attempt at change and improvement is made at the systemic level to affect the “regularly interacting set of components.”

Based on this last model, he offered a coffee pot image with a spout on the same side as the handle, saying: “Safety is a product of design; it's not a natural consequence.”

But, he also noted, “the standardization and care in other industries is very different than in healthcare.”

In essence, Fineberg supported recommendations of the “Chasm” report that advocated redesigning processes, making efficient use of information technology, designing new systems for safety, and changing production planning as ways to improve quality – all “concepts that are very fundamental to the laboratory,” he said.

And he noted similar efforts being undertaken in the laboratory arena, such as efforts by IQLM to set standards for lab and lab workers, in addition to being a forum for research and learning.

And he emphasized the need to look at these redesigns in terms of patient needs, instead of focusing only on the lab processes.

“I believe there is an opportunity to move from a specimen-centered role to a patient-centered model [in clinical labs],” Fineberg said.

In a final nugget of wisdom – one that must have had many in his audience scratching their heads – Fineberg quoted Grateful Dead icon Jerry Garcia: “Something has to be done, and it is simply pathetic that we are the ones that have to do it.”