First IQCP template set up for molecular tests

Another question he hears often: Will IQCP reduce the amount of QC testing that I have to perform with my laboratory testing?

On this they have become explicit, he says, about what the point of an IQCP is. “The IQCP is there so you don’t have to do daily QC. If you want to do daily QC, you don’t need an IQCP. So this may relieve labs a little, and we’re being explicit about it.”

For Dr. Palavecino, the question she gets most commonly is: We have three identical instruments in our laboratory. Can we do a single IQCP for all three?

“That’s an old question, but still I get it a lot,” she says. “I tell people if they have three instruments in the same location, it is okay to do a risk assessment once and include the three instruments. But if the instrument is in another hospital, even though they’re in the same system, they have to do their own risk assessments.”

Dr. Campbell too fields the same question. “If you have multiple identical instruments in the same location, you don’t need a separate IQCP for each one,” he agrees. “But the same instruments in different locations have different risks, due to physical location, personnel involved, different patient populations. For example, if you have an instrument that’s located in your pediatric emergency room satellite lab and one in your cancer center satellite lab, there may well be differences in risk assessment for both because children are different from adult cancer patients.”

How often the IQCP needs to be reviewed and revised is the question Dr. Filkins gets most often. “Our CAP checklist defines how often you have to reapprove an IQCP, so I think most labs are familiar with that component,” she says. “However it’s not always at the forefront of people’s minds that when there’s a failure or an indication of failure at any point in the process, they have to troubleshoot and try to find the source of the error.

“When they make the conclusion about a source of error,” Dr. Filkins continues, “they should go back and reassess their risk assessment and risk assignment, and determine—now with new information—whether they are comfortable with what happened. Do they understand the source of risk that occurred and has it been fixed, and is it unlikely to happen again? Is this an indicator that their instrument is getting old or their QC material is not as stable as they thought? Is there something that would change their perspective on what that level of risk is and that they therefore would want to include in their quality control plan?”

“Maybe they want to increase the frequency of their external quality control testing,” she says. “Perhaps there is something additional they would want to include in their quality assessment—the third component of the IQCP.” When there’s a major failure, she adds, laboratorians should reassess their IQCP as a whole and determine if it needs to be changed, revised, and reapproved.

A two-year IQCP review is an opportunity to make sure it’s up to date, she says. “As a laboratory director, when I sit down to review our protocols or our IQCP, I always have had different experiences in those past couple of years that might trigger something, where I say, ‘Oh, I didn’t realize it was written this way,’ or ‘We now have this other report that we evaluate every year and we should be including that.’”

Dr. Palavecino shares an incident in her laboratory when she, too, realized she needed to review her IQCP. “My QC failed and continued failing for three days. My original IQCP included documentation that showed no QC failures for this system. I had to review my IQCP and do a new risk assessment to figure out why I was getting failures with my QC for one particular organism-antibiotic combination.” They found the cause: A change to the air-conditioning system caused one of the vents to blow cold air on top of the instrument and lowered the temperature in the instrument. Blocking the vent was an easy fix. “This highlights that changes in environmental conditions can modify the original risk assessment results and require risk reassessment,” Dr. Palavecino says.

“We need to pay attention to everything. It’s not only the reagents, the organisms, and the instrument, but the outside environment as well. Everything plays a role.”

What minimum frequency of QC testing is allowed when using an IQCP is another oft-asked question, Dr. Filkins says, “because the answer to the question is not prescriptive and not one-rule-fits-all-labs. It depends on the testing method you’re using.” Some accrediting agencies do have a minimum. “The CAP, for example, has a minimum frequency of QC that’s required for antimicrobial susceptibility testing. Even though CLIA and the IQCP rules do not specify, the CAP does. If your accrediting agency has a minimum, then clearly you need to at least cover that minimum.” Laboratories also need to meet the minimum that the manufacturer requires, she adds. “And beyond that, the minimum amount should be determined based on your findings within your IQCP. What is your risk level, and what role would external quality control testing play in helping you to assess if there are errors?”

Drs. Campbell, Filkins, and Pala­vecino hope their efforts and the resulting new and revised templates will provide labs with as many examples of risks—and the data needed to find and correct related errors—as possible. Says Dr. Campbell: “In the revisions we made incremental changes and came up with things that maybe were missing or unclear. We spent a lot of time trying to clarify language and make particular examples that would be exemplary and useful to people.”

The essence of the IQCP, Dr. Filkins says, is to help achieve the highest quality of testing by recognizing all sources of potential error. “The update of these templates provides a great opportunity for lab directors and designees to assess their current IQCP processes and determine if there’s room for enhancement, improvement, clarification, or adjustments. These templates do not suggest that you have to adopt them or that there’s anything wrong with the prior versions,” she says. But they are a good opportunity for a laboratory to reflect on its existing processes, she adds, and determine if improvements can be made.

Valerie Neff Newitt is a writer in Audubon, Pa.