BY SHERI PORTER
 Most office labs adhere to federal regulations and offer safe, convenient procedures such as blood draws so patients don't have to travel to an outside facility. |
If your office lab is categorized as a waived lab or a provider-performed microscopy lab -- and more than 35,000 AAFP members do have these facilities -- you'd best make sure your lab is up to snuff.
The Centers for Medicare & Medicaid Services has expressed growing concern over statistics it gathered from random, on-site laboratory surveys in 2002 and 2003. CMS surveyed 897 labs in 2002, and 2 percent had deficiencies of "immediate jeopardy," or imminent and serious risk to human health. The 2003 figures were worse: 3 percent of 1,756 labs surveyed fell into the immediate jeopardy category.
Barbara Mitchell, manager of laboratory issues and AAFP-PT, the Academy's proficiency testing program, recently attended a Clinical Laboratory Improvement Act Committee meeting in Atlanta as an unofficial liaison. She returned saying waived/PPM labs appear to be in trouble.
At that meeting, CLIAC heard that 70 percent of all medical decisions involve some type of laboratory result. Bottom line: Those results had better be accurate.
"I'm not trying to be an alarmist; I really see a problem here," said Mitchell. These numbers may lead CMS to the conclusion that labs need more oversight, she warned, adding that most labs do a good job and wouldn't welcome tighter federal regulation.
The Clinical Laboratory Improvement Amendments were enacted in 1988 to provide government oversight of medical labs. The Academy began its proficiency testing program in 1990 and fought hard to exclude many family physicians' office labs from CLIA regulations (for example, by supporting expansions in lists of waived tests). The CLIA regulations took effect in 1992. Currently, nearly 150,000 waived/PPM labs exist in the United States.
Education is the key
Don't worry about increased federal oversight, said Judith Yost, director of the Division of Laboratories Services for CMS. "That's not the goal at all." The CLIA program's desire is to improve the safety of lab testing through education, she said.
| Laboratory resources available The Academy has tools available to help physicians operating office labs. Check into these possibilities:
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According to Yost, poorly trained lab technicians are often at the root of the problem. These are people "not trained in laboratory medicine," she said, and low wages contribute to a 40 percent annual turnover rate. The end result is employees who fail to follow manufacturers' instructions for how to perform tests and who don't adopt quality control measures.
Much to Yost's surprise, CMS' random surveys have been positive teaching opportunities at labs across the country. "These folks are just happy that somebody is coming to show them what to do, and how to do it right," she said.
Mitchell agreed that education is the key. "We need to be proactive," she said. If this situation goes unchecked, she added, "It's just a matter of time before a bad outcome is tracked back to one of these waived/PPM labs."
Time to take action
CLIAC recommended the following actions:Publish CMS' survey results. CLIAC members -- in their capacity as the advisory board to these labs -- are appalled by the CMS data, said Mitchell.
Send a letter to HHS Secretary Tommy Thompson outlining the committee's alarm at the poor state of some waived/PPM labs.
CLIAC also discussed the need to develop best-practice guidelines for performing laboratory medicine.
In addition, Mitchell suggested these steps:
Explore ways for the Academy to advocate for physician office labs and make certain the AAFP has representation at the next CLIAC meeting to argue that waived/PPM labs are integral to the practice of medicine.
Highlight educational opportunities available through the AAFP (see box to the right).
To reach writer Sheri Porter, e-mail sporter@aafp.org.
FP Report is published by the AAFP
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Copyright © 2004 by American Academy of Family Physicians.