Patricia Mullenix, BS, MT(ASCP)SH, hematology and satellite technical manager for Memorial Health University Medical Center (Savannah, Ga), had a question—not a life-or-death question but one with significant economic impact for her labs.

“The CAP [College of American Pathology of Northfield, Ill] fibrinogen quality-control regulations are lumped in with the factor assays, but fibrinogen is not done like a regular factor assay. It is not reported as a percent of normal; it is done on a calibrated curve and reported as milligrams per deciliter. The regulations stated that every time we ran the test, we needed to run both levels of control. But running 10 or 15 a shift is very expensive and didn’t seem necessary on the automated equipment,” Mullenix says. So she wrote to CAP.

She received an answer within a few weeks. She was told the regulations she was inquiring about applied only to fibrinogens done manually, not automated testing; she needn’t run the controls as frequently as she was doing.

“I couldn’t find that information anywhere,” Mullenix says, adding that situations like this arise frequently. If CAP had taken longer to respond, Mullenix would have spent the money to use the controls incorrectly during the time she waited for an answer; doing so would have been the only way to be sure she met the requirements and maintained optimum patient care, but the process seemed wasteful.

According to the experts Clinical Lab Products spoke with, confusion regarding regulations is almost as standard as the rules themselves. Efforts to eliminate confusion and produce regulations better suited to today’s equipment, at least regarding QC [quality control], resulted in equivalency quality control, or EQC, which created more confusion.

Many in the industry feel this methodology doesn’t provide the needed solution; even CMS offers a qualifier: “Since the purpose of control testing is to detect immediate errors and monitor performance over time, increasing the interval between control testing (ie, weekly or monthly) will require a more extensive evaluation of patient test results when control failure occurs (see 493.1282). The director must consider the laboratory’s clinical and legal responsibility for providing accurate and reliable patient test results versus the cost implications of reducing the quality control testing frequency.”1 James O. Westgard, PhD, translates this to mean, “While the CMS has explained what ‘equivalent QC’ is, they are not willing to state that it is clinically or legally defensible. If you follow this procedure, basically you’re on your own.”1

So what is a lab director to do? Ambiguity is one of the primary challenges presented by clinical lab regulations, and the solutions are not always straightforward. Suggestions range from obtaining new information to new technology to new regulations. But all of them take time—Mullenix feared waiting months just to find out about fibrinogen quality controls.

But lab directors needn’t despair entirely. Both regulatory agencies and manufacturers are willing to help with interpretation and compliance, and those efforts shouldn’t take an ice age.

Read the Instructions
The first challenge presented to lab directors is to keep up with the regulations. “Keeping current is always a problem, particularly with Joint Commission [Joint Commission on Accreditation of Health Care Organizations, or JCAHO of Oakbrook Terrace, Ill) and CAP, because regulations are updated on a regular basis. The regulations keep changing, and it seems as if the requirements keep expanding. It’s a full-time job,” says Sharon S. Ehrmeyer, PhD, MT(ASCP), professor of pathology and laboratory medicine and director of the medical technology program at the University of Wisconsin (Madison).

Having multiple agencies that provide oversight is also confusing. “They don’t all have the same requirements, so we have to determine which is the most stringent and then meet that one to be sure we’ve met them all,” Mullenix says. She lists the Centers for Medicare and Medicaid Services (CMS of Baltimore) Clinical Laboratory Improvement Amendments (CLIA), CAP, Clinical and Laboratory Standards Institute (CLSI of Wayne, Pa), the US Food and Drug Administration (FDA of Rockville, Md), and the state government as some of the organizations whose updates she must monitor.

Stuck in the 1970s
Many times, the regulations are tied to CLIA. “When we are talking about clinical laboratory regulations, we are basically talking about CLIA 88, and the way CMS, formally HCFA, has chosen to implement the regulations in the country,” says Ronald H. Laessig, PhD, professor of population health sciences and professor of pathology and laboratory and medicine at the University of Wisconsin (Madison).

Despite updates, most recently in 2004, Laessig feels the regulations are “stuck in the 1970s” and that much ambiguity, particularly in quality control, arises from the incongruity of these antiquated requirements and today’s technology. “Concepts, like two controls per test per day, calibration, calibration verification, and method validation, are hopelessly outmoded with today’s instruments,” he says, using an auto analogy to illustrate.

“Suppose that a federal agency dealing with cars came up with a regulation that the clutch pedal must be on the right and the brake pedal on the left. Then you buy a car with an automatic transmission. It doesn’t meet the standard because the clutch pedal is not on the left—because there is no clutch pedal. It is perfectly functional, but it doesn’t meet the standard. Now we have exactly that situation with instruments, where they don’t meet the CLIA rigid control and calibration requirements,” Laessig says.

Laessig believes the solution lies with performance-based standards. “If we hang onto the old regulations, by analogy, we would never be able to see modern automobiles with automatic transmissions. We have to rethink our CLIA-based regulatory philosophy so we can manufacture instruments and verify their performance based on quality-driven, performance-based standards,” he says.

Follow the Instructions
Max Williams, director of policy and external affairs for COLA (Columbia, Md), notes that with EQC the government intended to create some flexibility in the regulations. “Based on good science, devices, etc, the lab could do less-frequent QC if certain criteria were met. The regulations have told us what kinds of devices but not which devices will count in that category, so it’s up to the lab director and the device manufacturer to work that out,” Williams says. He acknowledges that it is a large responsibility for the lab director to assume.

Manufacturers can help by making their case directly to regulators, but the process is slow, even if the company is aggressive. According to Laessig, CMS does not have the resources to approve every manufacturer’s different methods of quality control. Quoting an anonymous colleague when talking about the speed with which regulations are updated, Laessig notes, “Glaciers are swift by comparison.”

But the industry is moving ahead, putting R&D dollars into making devices easier to use and incorporating more quality control on board, says COLA’s Williams. This, too, is not without challenges.

“Waived-only testing requires that a lab get a CLIA certificate and follow the manufacturer’s instructions. But new data shows that labs don’t have the current instructions and aren’t doing the bare minimum. Some evidence suggests the misuse of these tests can impact patient care. So the burden is on the manufacturer to make a device so simple that it has a negligible impact on patient safety if done incorrectly,” Williams says.

Ask an Agency
Much emphasis in the past has been on following the manufacturer’s instructions. Devices are approved by the FDA within certain parameters, with deliberate labeling and instruction. “The manufacturer’s instructions are a pretty good default. I don’t know of a case where the accreditor would tell you to perform a test in a way that is different than what the manufacturer states,” Williams says.

But there may be extra activity, such as more QC, and if that is the case, then the lab needs to follow what the oversight agency states. “If you have a different opinion, you can go through a process to ask for a different analysis or position. But, in the meantime, because it involves public health, you should follow the requirements in a literal situation,” advises COLA’s Williams.

Williams feels that the government and accrediting agencies have taken great pains to make sure labs are informed about what new regulations mean, providing opportunity before it becomes required to work with it and that the agencies are available to resolve issues when they arise. Accrediting agencies, such as COLA, JCAHO, or CAP, provide mechanisms for questions to be answered. With CLIA, according to Ehrmeyer, it can be more difficult.

“If it’s a compliance (with federal CLIA requirements) issue, you can use your accrediting organization to help you. If it gets down to a real ambiguous situation, which we’ve seen, we’ll ask for clarification from the federal CLIA program. On some issues, COLA may not necessarily have a position, but we can help facilitate an information exchange,” Williams says.

Help Yourself
COLA can help a start-up lab get going, providing guidance from a practical rather than a device-specific perspective. However, each lab is different, and the same solution may not be appropriate for all.

“For example, quality-assessment programs may be different in a five-person physician office lab than in a 100-person reference laboratory. But the function of the quality-assessment plan is the same. So how you get to it will be different, but it will serve the same purpose. We developed turnkey plans to give labs a kick-start, but tools such as these help only to the degree you help yourself,” Williams says.

That puts a lot of responsibility on lab directors, but when it comes to regulations, they are likely used to it. Unfortunately, there is no easy answer to regulation dilemmas. Those with questions have to wade through the available resources, manufacturers, and accrediting agencies, until they receive an answer. In the meantime, labs must try to comply.

“There is no choice. The end user—the people in the lab—are not in a position to argue,” Ehrmeyer says. “People should do the best that they can.

“If the inspector doesn’t like it entirely, ask for suggestions. But you have to try.”

1. Westgard JO. CLIA Final Rule: “Equivalent” Quality Control Practices. January 2004. Available at: Accessed June 22, 2006.

Renee DiIulio is a contributing writer for Clinical Lab Products.