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.
Unlike at some other institutions, many of the VA Connecticut point-of-care operators are in the OR setting. So the i-Stat, for example, is operated by anesthesiologists, perfusionists, certified nurse anesthetists, and one anesthesia technologist. This range creates complications. “That’s four categories of people, some of whom only provide coverage on fairly rare occasions,” Dr. Campbell says.
“We also have people who only come in for night coverage. So we’re maintaining competency on the i-Stat on this group of about 25 people at various levels of training. They have different schedules and all of them are busy. It’s an ongoing challenge and it takes a lot of time and diplomacy on the part of the POC coordinator.”
An important part of developing an IQCP is looking at every sample type and making sure specimen collection is adequate and correct, McGovern says. But Dr. Campbell finds the addition of pre- and postanalytical phases to risk assessment to be a redundant requirement. “The problem is that stuff is already on CAP checklists and Joint Commission checklists. So it’s just a bunch more lines to put on your IQCP risk assessment. It’s not a horrible thing to have to sit down and go through again, but it’s nothing new.”
The VA Connecticut IQCP process resulted in keeping its QC program the same as before IQCP implementation, although with more documentation. Dr. Campbell regards the adoption of IQCP as equivalent to fixing a non-problem and not a good use of health care resources. “I don’t think there were documented issues with EQC that required a rather laborious and elaborate replacement. So anything to streamline IQCP would be good.”
In the meantime, his advice to POC coordinators who are developing IQCPs: “Don’t just take what the manufacturer gives you. Add your own clinical and technical judgment to it. And make sure you do a thorough job with your risk assessment.”
Admittedly, Kerstin Halverson, BA, MS, contemplated IQCP with something less than enthusiasm a couple of years ago. At Children’s Hospitals of Minnesota, a two-hospital system where she is point-of-care coordinator, she was the lone staff member charged with developing IQCPs for three sets of moderately complex devices: 35 i-Stats with about 300 operators across all areas, eight Medtronic ACT Plus systems, and three Avoximeters.
For her, the main challenge in developing the risk assessments was talking to the operators, mainly nurses and respiratory therapists. “I made lots of appointments, talked to key players, observed operators, and said, ‘Okay, this is what I think you are doing versus what I have in my procedures. Are you following the process? Is this what happens on a case?’” She explained to operators that her purpose was to help them out so they don’t need to perform QC every eight hours.
Addressing the environment was not much of a problem with the ACT Plus and Avoximeter, Halverson notes, because operators don’t have to worry about reagents being refrigerated. “The i-Stat, however, does have a shorter outdate on its cartridges once they’re removed from the refrigerator. So we have staff sign them out and date them right then and there, or we try to encourage that, but we’re not always sitting there when they come take them.” It’s a struggle to make sure the sign-out happens correctly, she says. “Follow-up spot-checking on cartridges stored at room temperature shows us they are dating them, though.”
Halverson suspects some laboratories may be going overboard in generating multiple IQCPs tailored to different point-of-care locations. “It depends on how you quantify the differences. If you have the same staff who are moving through different departments and operating the same devices in the same fashion, then the devices will be handled the same.” She has opted to do fewer IQCPs for this reason.
Her advice to laboratory managers assigned the task of developing IQCPs is not to go it alone.
“Obviously, you have to do your own IQCP. You can’t just expect to get one from somebody else. But do not be afraid to reach out to other coordinators to see if they can help. All the vendors out there have also provided the help I’ve needed. They have information to get you through the risk assessment that will help to answer the questions you will have covering the preanalytic, analytic, and postanalytic testing phases for each device. They don’t tell you how to collect your specimens, but you should already have your procedures in place for that. So everything’s there already. It’s just a matter of pulling it together into one document.”
Fortunately for harried laboratory directors, an amazing array of tools has been forged for developing IQCPs. “Theory is a little bit separate from practice, and when it comes to putting pen to paper, IQCPs may not appear so simple,” says Valerie Ng, PhD, MD, chair of laboratory medicine and pathology at Highland Hospital in the Alameda Health System, Oakland, Calif. “But there are so many resources available, it’s phenomenal. I would just encourage everyone to do what I did and consult the templates, the websites, and the webinars that are out there.”
Dr. Ng, for one, sees IQCPs as a positive step for the laboratory. “To me, this is the light at the end of the tunnel. It gives us the flexibility to focus on the things that are high risk and draw back from the things that are less critical. Where else can you get that kind of opportunity?”n[hr]
Anne Paxton is a writer and attorney in Seattle.