COLA White Paper Urges New Focus on Office Lab Protocols

Control Utilization, Identify Risks, Coordinate Results

November 17, 2014 02:02 pm Sheri Porter

Family physicians may be surprised to learn that laboratory testing is the single highest-volume medical activity performed in the United States. In fact, according to authors of a white paper( recently released by the laboratory accreditation organization known as COLA,( some 13 billion tests are performed every year.

[Lab test tubes]

But arguably, the most important statistic reflects what happens after those tests are performed.

"About two-thirds of clinical decisions are based on laboratory test information," said the authors of the COLA paper, which is titled "Integrating Laboratories into the PCMH Model of Health Care Delivery."

And then there's this to consider: "Lab testing is often directive of more costly downstream care," they said.

That's why COLA leaders -- using the white paper as a communication vehicle -- are encouraging physicians and their laboratory personnel to establish practices that align with patient-centered medical home (PCMH) standards in three key areas:

  • controlling test utilization;
  • identifying risks and controls for all three phases of laboratory testing (pre-analytic, analytic and post-analytic); and
  • coordinating lab results among primary care physicians, other health care professionals and patients in the PCMH neighborhood.
Story Highlights
  • COLA, a U.S. laboratory accreditation organization, recently released a white paper urging physicians with office labs to establish tighter protocols to help reduce testing errors and redundancy.
  • Researchers found a U.S. redundancy test rate of more than 20 percent and noted that overutilization can lead to higher costs and an increased likelihood of false results that result in, among other things, incorrect diagnoses and unnecessary medical interventions.
  • COLA has developed a program called Patient-Centered Laboratory Excellence that aligns laboratory practices with patient-centered medical home standards by addressing quality in the office lab.

COLA researchers pored through hundreds of articles on inappropriate testing published in peer-reviewed journals, eventually identifying 42 publications that met researchers' criteria for evaluation. Ultimately, the researchers discovered a U.S. test redundancy rate of 20.6 percent.

"Ramifications of overutilization go far beyond laboratory costs, unnecessary sample collection and the burden placed on health care resources," wrote the authors. "Downstream effects include increased likelihood of false results leading to incorrect diagnoses, unnecessary prescription drugs, longer hospital stays, and additional medical or surgical interventions," they added.

Aligning Lab Practices With PCMH Standards

According to COLA Chief Operating Officer Paul Campognone, the PCMH model has gained wide acceptance across the country -- with some 8,000 practices having received PCMH recognition from the National Committee on Quality Assurance (NCQA).

"NCQA looks at 27 different areas, but none of those criteria address quality in the office laboratory," Campognone said in an interview with AAFP News.

"COLA has developed a program called Patient-Centered Laboratory Excellence (PCLE)( that provides evidence that the criteria that we use for PCLE recognition by COLA will have an impact on the quality of laboratory tests and economics of laboratory tests that are delivered through the PCMH," he said.

The hope, said Campognone, is that third-party payers will realize the benefits of the PCLE program and will affirm that value by providing financial incentives to labs that attain PCLE recognition.

Avoiding Errors, Reducing Repeated Testing

Testing redundancy was high on Campognone's urgency list. He noted that in a multispecialty practice, the results of a single lab test could be used multiple times by a patient's primary care physician, as well as by other subspecialty physicians who are part of the health care team. He used the following example to illustrate his point: "A patient visits his or her primary care physician, who orders a CBC (complete blood count); then that same patient returns the next day for an appointment with a urologist in the same practice, who orders another CBC because the prior day's results were not available.

AAFP Supports COLA Recognition Program

Barbara Mitchell, M.S., M.T., is deeply involved with laboratory proficiency testing (PT) at the Academy in her professional role as manager of AAFP-PT and laboratory issues.

Mitchell, also a member of the American Society for Clinical Pathology, told AAFP News that more than 70 percent of all medical decisions involve laboratory test results. "Convenient and timely access to quality laboratory testing is essential to patient care and management and is therefore a vital component of the patient-centered medical home (PCMH) model," said Mitchell.

"The AAFP has a long history of collaboration with COLA on physician office laboratory issues. We support COLA's efforts to develop the PCLE (Patient-Centered Laboratory Excellence program) and are excited to have laboratory medicine recognized for its role in the PCMH," she added.

"Who is responsible for controlling that redundancy? We believe that the lab is responsible for a big part of it and should have systems in place to reduce that redundancy," said Campognone.

Individual labs also can institute procedures to control errors. "We know that most errors that are attributed to a laboratory test occur before the test gets to the lab or after it leaves the lab," said Campognone. Simply labeling a patient's lab specimen with two identifying pieces of information can minimize the risk of these errors, he noted.

Physicians who work in a multidisciplinary practice (and even those in small or solo practices) probably have a waived office laboratory, said Campognone.

According to the Clinical Laboratory Improvement Amendments program administered by CMS and supported by the CDC and FDA, tests performed by these waived labs( are categorized as simple lab examinations and procedures -- such as a urine dipstick or a fingerstick to obtain a blood glucose level -- "that have an insignificant risk of an erroneous result."

"We do know that there are more than 165,000 physician office labs in the United States that have a certificate of waiver. If you're a single-physician office, you can control a lot of potential errors because of your size," said Campognone. "But in a large PCMH practice that may have 30 physicians, it's more difficult to control utilization of the laboratory since there are 30 customers for that laboratory."

Furthermore, Campognone pointed out that when multiple physicians use the same lab test, the accuracy of that test becomes even more critical.

"Imagine that if you, as the physician, were holding two reports of the same test for your patient, and each showed different results. Someone would question that. But if there's only one CBC, and you've got three physicians using those test results, the accuracy becomes more important because there's no check and balance," said Campognone.

Bottom line, family physicians should care about laboratory excellence because the better they can control the elements in the PCMH, the better their patient outcomes will be.

"We don't want laboratory testing performed in error, we don't want redundancy, and we don't want inappropriate testing performed," said Campognone. "And it's our assumption that the bigger the practice, the more likely it has a laboratory -- at least a waived lab," he added.

"The only way to make sure that you're getting quality results is to begin to look at some things we currently aren't evaluating when we accredit laboratories under the current regulation model," Campognone said.

Related AAFP News Coverage
Proposed Rule Could Ease Regulations for Rural FPs, Office Labs
AAFP to CMS: 'Vague' Language Needs Clarification


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