Making a smooth pivot to point-of-care IQCP

Anne Paxton

May 2016—Practically speaking, there’s a limit to the number of balls a human can juggle. And there’s probably a limit to how complex a quality control plan a point-of-care testing coordinator can handle. Last year, many POC coordinators felt that the Centers for Medicare and Medicaid Services would be pushing that limit pretty hard with its new Individualized Quality Control Plan.

The voluntary-in-name-only QC program had a Jan. 1 deadline, but Adonica Wilson, MT(ASCP), confesses that when she contemplated developing an IQCP, she procrastinated a little, in hopes that the program would somehow get canceled.

“I was one of those ones holding out hope that something would change before the end of 2015,” Wilson says. So, as point-of-care coordinator for Nemours/Alfred I. duPont Hospital for Children in Wilmington, Del., she left only a month or two to complete her IQCPs before the Jan. 1 deadline. Still, she was pretty well prepared. “We knew it was coming, and I had been going to seminars and webinars on it for the last two years.”

As it turned out, the IQCP didn’t pose any major differences from the Equivalent Quality Control program that had been in place for years at Nemours/duPont. “What we did to validate our testing was actually working. We had very few QC errors. We had lockout in place, so if there was a problem, we tried to mitigate it right at the source.” In effect, “Our plan under IQCP is pretty much the same as what we had before; we just had to justify it.”

Wilson prepared three IQCPs, for the Accriva Hemochron Response whole blood coagulation system (200 operators), Abbott i-Stat (470 operators), and Radiometer ABL80 Flex Co-ox blood gas analyzer (five operators). “We had more moderately complex tests than that, but we only did the ones that had electronic or internal quality control.”

For a week, she did nothing else but IQCP. “I’d sit down in the morning and start writing and gathering data. That was the biggest thing—all the QC reports, any complaints of instrument malfunctions, instrument checks, and so on.” Under EQC, she did not have to put out actual reports. “I would look at the reports monthly but with lockout and store, it wasn’t as difficult as IQCP, which requires pulling and going through each data point and making sure everything was perfect.” She also went to a couple of the units to observe and asked nurse managers to see what problems their staff had encountered.

IQCP brought in other new elements because EQC did not cover preanalytical and postanalytical phases, Wilson notes, adding that laboratory personnel can find it hard to incorporate these phases into their concept of quality control. “The distinction most people make is that QC relates mainly to the analytical phase. It would make more sense to call it a quality assurance plan.”

Her IQCP led her to put up more tip sheets, “so people would know the importance of expelling air out of the syringe, and running a lactic acid first before any other testing.” While the process for the end user has not changed as far as showing that internal checks and QC are working as they’re supposed to, she says, “we now have reminders up for them to use if they need it.”

For example, one tip sheet will show what effect a clotted sample or a hemolyzed sample will have on results. “Another issue we have on occasion is an incorrect sample type. When they run a blood gas syringe or any of the i-Stat tests, they have to indicate whether it’s an arterial, venous, or a PIC sample type. If you select arterial when it’s actually venous, it will indicate critical results where they shouldn’t be. So we included in our IQCP that operators should be trained to be cognizant of sample type.”

Second in a series. Last month: IQCP without agony at the point of care

Environment is also an important preanalytical factor. “The i-Stat has a certain range for humidity and won’t work outside of that range; it’s part of the instrument’s internal QC. Our command center also monitors humidity in our ORs, but outside the ORs, there’s a possibility for the i-Stat not to work correctly. The instrument has a 90 percent non-condensing humidity window; if it falls outside of that humidity, it won’t give you a result. It will give you an error code.”

As part of the environment portion of her i-Stat IQCP, Wilson included training as an i-Stat mitigation feature. “So the operators would get training that if they get that error code, it would mean they would have to send the test to the lab instead of running it on the i-Stat.”

Test system factors listed in her IQCPs include “Use beyond intended use.” “That sometimes comes up where, for example, you want to make sure a test is only used on whole blood. We train operators to make sure they know you can’t use the test on other body fluids.”

Competency was one of the key preanalytical areas for all three of her IQCPs because of the documentation requirements. “A lot of times people do competency—their training plus the annual competency—but they don’t document it. Now, each unit will have a blitz of training or a couple of days where all their operators will have direct observation and they’ll do troubleshooting using a check-off list for each type of testing they do. Once they finish that, they’re supposed to document it so I can find it.”

One change in preanalytical QC that her laboratory plans as a result of IQCP: “We are going to institute the positive patient ID feature on our i-Stat.” Now, when a patient’s wristband is scanned, the i-Stat just shows the patient’s financial number. “With this new feature, the actual name and date of birth display, and then they can verify it is the patient by matching up the armbands.” As she notes, in a children’s hospital, it’s impractical to rely on oral confirmation.

As for the postanalytical phase, Wilson cites downloading at docking stations, interfacing through Telcor middleware, and sending results first to the Sunquest LIS and from there to the HIS (Epic), which posts them to the electronic medical record. “That’s all included in the IQCP for each instrument.”

Wilson sees the IQCPs’ impact on cost as neutral for Nemours/duPont. “I know some sites did liquid QC and were doing it every week, so their IQCP could have made them go down to every 30 days, which would save them money.” At Nemours, she says, “We couldn’t reduce our QC any more than what we were doing, so there wasn’t necessarily a cost savings or an increase.”

On balance, developing her IQCPs was not as bad as she feared, Wilson says. “Most everybody, if they’ve had a QC program going for any amount of time, has the data. You’re probably covering all of your steps, all of your failure types, and you’re probably already mitigating them. It’s just a matter of pulling it all together and putting them on paper. And once you do one, the others are easier.”

At VA Connecticut Laboratories, IQCP was not a welcome change, but the laboratories knew it was unavoidable for point-of-care testing, says Sheldon M. Campbell, MD, PhD, director of clinical laboratories and associate professor of laboratory medicine, Yale School of Medicine.

For its nonwaived POC testing, VA CT Laboratories have two i-Stats in the OR, four Hemochron Signature instruments for activated clotting time—two in the OR, two in the cardiac catheterization lab, and two Accriva Avoximeters in the cardiac catheterization laboratory.

Whether a nonwaived test requires an IQCP depends on the devices, says Dr. Campbell, a member of the CAP Checklists Committee. “For the devices we had, an IQCP is pretty much essential. The cartridge-based tests are relatively simple and have longer QC intervals designed in, but the cartridges and control materials are expensive. So on a practical level, it would not make sense to try to do daily QC.”

Conducting the risk assessments posed challenges, says Kim McGovern, MT(ASCP), VA Connecticut point-of-care coordinator. “I think the hardest thing for me was figuring out the severity of some of the consequences if particular things occurred.” She says Dr. Campbell provided expertise on what would cause harm and how severe the harm would be.

That severity component is very much a clinical decision, Dr. Campbell says. “It requires a medical assessment of how the test is used in what kind of patients, in what clinical settings, and what adverse consequences you’d expect with an inaccurate result in those different settings.” He based this assessment primarily on his own experience, but he also talked with providers in the OR and catheter laboratory to discuss how the tests performed in a few cases.