IQCP without agony at the point of care

Create PDF

Anne Paxton

April 2016—For many point-of-care testing coordinators, the prospect of developing Individualized Quality Control Plans is far from enticing. But there has never been much chance that laboratories could opt out of the Centers for Medicare and Medicaid Services’ new quality control framework for much of their nonwaived testing.

Even though IQCP is an optional program, says Kerstin Halverson, BA, MS, point-of-care coordinator at Children’s Hospitals of Minnesota, the alternative—meeting the minimum QC requirements set by CLIA ’88—is often impractical. “I didn’t stop to calculate what it would cost to do liquid quality control on all the i-Stat cartridge types every eight hours because the number would have been through the roof,” she says.

Dr. Valerie Ng (left) with Highland Hospital laboratory operations manager Feuy Saechao. Dr. Ng’s advice for point-of-care coordinators: “Don’t overthink risk assessment.”

Halverson saw IQCP development as a “necessary evil”—optional, yes, but essential to offset the costs associated with meeting minimum QC requirements. Like many in the laboratory community, she thought that the CMS Equivalent Quality Control program, in place since 2004, was working just fine. But now that the Jan. 1, 2016 deadline for developing IQCPs has passed, she and other POC coordinators qualify as survivors of the new process. And some are saying the switch to IQCP wasn’t that bad.

In fact, a few, like Lou Ann Wyer, MS, MT(ASCP), were early adopters of IQCP and the companion EP23 program, known as the “IQCP rulebook,” published by the Clinical and Laboratory Standards Institute. EP23 guides users on developing a fishbone diagram for hazard risk assessment, the three phases of testing required by the IQCP (preanalytical, analytical, and postanalytical), and the five areas required: samples, people, reagents, environment, and instruments.

“I was probably one of the very few excited about the release of EP23 from CLSI, and so I preordered it. When it arrived, I jumped right on it and started working up some of the analytes,” says Wyer, who is director of laboratory services at Sentara Healthcare in Norfolk, Va. Still, to get all the point-of-care IQCPs completed, “we worked right up to the deadline.”

Sentara’s clinical specialist for POC testing Shirley Church led a team of point-of-care coordinators through each of the test systems that qualified for an IQCP. “It resulted in doing more than 70 risk assessments for 20 IQCPs within our integrated POC program,” Wyer says. “We have multiple hospitals, and a very large POC program, and we had to look at a risk assessment for each facility where POC tests are performed.”

Wyer

The laboratory’s decision to do separate risk assessments for each analyte in a cartridge-based system is the reason for the large number of IQCPs. In addition to its Accriva Diagnostics Avoximeters and Medtronic Hepcon coagulation analyzers (also subject to IQCPs), Sentara has about 400 Abbott i-Stats. “We analyzed each parameter’s performance within a cartridge over time across all devices, identified our laboratories’ expectations for quality control performance, and then determined the frequency level of quality control needed based on all data evaluated. In the end,” Wyer says, “our QC plans pulled all these elements together and based our QC frequency for the cartridge on the parameter that requires more QC.”

Since risk assessment under IQCP must also take into account the number of POC testing locations, a large POC program like Sentara’s has special challenges. “With 400 testing locations—including cardiac cath labs, radiology, respiratory, central OR, cardiac OR, emergency departments, ICUs—we determined if there were differences in risks based on the different locations. If there are similarities, you can group them together.”

With competencies, for example, there may be good reason to develop separate IQCPs. “For areas new to POC testing or with new procedures, we like to give them a little more personal attention to make sure they’re on the right track.” With each risk assessment, she says, “we looked at complaints, concerns, errors, variances for all our operators. Within the preanalytical phase, sample collection and handling is always an important factor.”

The CLIA default to perform at least two levels of QC each day prior to patient testing can be very difficult and expensive for some systems, Wyer notes. “With instruments that have internal QC, you can perform your liquid QC at a frequency that meets your lab’s proven comfort level, but what we’re trying to get with IQCP is the ‘right’ QC. Your risk assessment is going to lead you to the right QC. Sometimes, based on your risk assessment, you might even want to increase the frequency of QC.”

Wyer’s IQCP analysis of the environment included temperature and humidity, of course, but also surfaces where analyzers are placed. “We asked whether the testing was done on a flat and level surface, without vibration or motion. We also looked at airflow and ventilation—anything that might alter the test results or is done outside the limitations of the manufacturer’s instructions.”

Nothing shocking was discovered, Wyer says. But having an instrument on a flat, level surface without vibration is important, especially for coagulation testing, and developing the IQCP highlighted that, in her view. “These details are used to train employees on the proper use of the instrument, included in competency assessments, and used to troubleshoot if staff have questionable results.”

For the postanalytical phase, Wyer says, the focus is getting the correct result to the correct patient’s record. This can include verification of interface transmissions and notifications from the operator in the event of a misidentified specimen. “All of this information is included as part of a risk assessment. We can look at the frequency of events, trends, and specific operators.”

After the laboratory developed a spreadsheet for each group of like cartridges or test systems, Wyer says, the risk assessment data were plugged in, including a list of policies, procedures, and job aids reviewed; training materials; investigations and complaints; product recalls; proficiency testing; personnel competency records; and observed errors. “The outcome of these reviews led us to modify the specimen collection and handling sections of our procedures.”

“From there, you can easily pull out what you want to include in your QC program, and then set up your quality assessments.” Her QC program has a standard format for the QC plan, which includes a header with the name of the hospital, cartridge type, testing location, and a summary of what the risk assessment showed.