By Gerald M. Davis, BS, MT (ASCP), MPH

Gerald M. DavisKeys to the successful implementation of autovalidation in the hematology lab
In today’s high-pressure laboratory environment, where laboratories are being asked to do more and more with fewer resources, autovalidation in hematology clearly helps ease the burden. Among its numerous benefits, autovalidation makes the highest and best use of a lab’s highly trained technologists, improves the efficiency of the lab’s workflow, saves staff from performing hundreds of tedious and time-consuming tasks every day, and dramatically reduces turnaround time (TAT) of test results. This last advantage goes to the heart of the lab’s mission: to provide the best in patient care.

Yet many labs are still reluctant to adopt autovalidation, or if they have adopted it, are not fully mining its potential. For some facilities that still validate all results manually, the issue is one of trust: can an instrument perform as reliably as trained technologists, considering that human health is at stake?

In other labs, autovalidation is being employed, but not nearly as effectively as it could be. The problems in these cases are sometimes more cultural than technical, although easily corrected if key decision makers are able to analyze their work systems, identify the problem areas, and make corrections as needed.

The current competitive environment leaves laboratories no choice but to increasingly automate. With workloads growing larger and staffing at most laboratories moving in the opposite direction, the resulting stress is bound to lead to medical errors unless automation can relieve some of the pressure. Autovalidation is a key to solving this dilemma, especially when labs take full advantage of what it has to offer.

Implementing autovalidation step-by-step
Autovalidation of specimens at our clinical hematology lab at the University of Michigan Hospitals takes place on multiple hematology analyzers in multiple locations within our facility. We process from 1,100 to 1,300 specimens per day, up from 700 to 800 a decade ago. Yet, we are handling this large increase in workflow with fewer FTEs than before.

This large productivity improvement is possible because more than 80 percent of our specimens are now autovalidated and electronically posted to patients’ charts. For that 80-plus percent portion, the loop on specimen result reporting has been closed, and the focus now becomes those specimens that have not met autovalidation criteria.

In my view, here are the most important steps to successfully implementing autovalidation:

Have a written policy for all laboratory tasks. I do considerable consulting with other laboratories on autovalidation. Sometimes while conducting staff interviews, I will get different answers from technologists about how a particular situation should be handled. This indicates that lab management has yet to formalize important policies. This is a sobering fact, considering the potential consequences for patients. It also shows that some crucial groundwork must be done before autovalidation is put on-line. That is, all lab protocols should be thought through and written down in algorithm form, with all exceptions known, so that medical technologists can focus on what they are trained to do when autovalidation criteria are not met.

From there, it is a simple task to capture those algorithms with the autovalidation software, which in our experience is flexible enough to handle any conceivable action or contingency. This process will not only make your laboratory more efficient, but also standardize care, and standardized care is widely viewed as better care.

Test the system in a “pre-active” phase before using it in a live production situation. The pre-active test shows you how accurately your autovalidation software and LIS interface carry out your algorithms. Any necessary adjustments can be made in this phase and tested again until the system is working perfectly and ready to be actively used.

Continually look for ways to increase your autovalidation percentage. If you are new to autovalidation, you may feel more comfortable with only autovalidating normal specimens at first. The more widely you use the feature, the more benefit your institution will realize from it. So continually review ways you can expand your use of autovalidation.

In our lab, we have increased our utilization of autovalidation to the point that only 20 percent of all tests, independent of abnormal, do not autovalidate. Many of these are autovalidated via deferment to a software rule-based interaction within the LIS. That is, they are checked against a user-defined verification algorithm before the results are autovalidated.

Eliminate pointless manual reviews. In some hospitals claiming higher standards of care, there are numerous specimens that get held for review by a medical technologist or pathologist. Most of these results will eventually be reported to the patient’s chart as is, without alteration. In the meantime, the system has longer TAT and a lower level of service. Clearly, the potential exists at these institutions to increase the percentage of specimens they autovalidate, and improve the overall institutional performance as a result.

Upgrade your LIS software if necessary. Institutions that have a working relationship with their vendor built into the LIS contract should never hesitate to request an enhancement. If your institution is using off-the-shelf LIS software, then make sure the product you use will deliver the performance you require.

Don’t be afraid to cross boundaries to make improvements in protocol. You aren’t likely to get something that you don’t ask for. It may not be usual in your institution for laboratorians to make requests of pathologists, instrument vendors, or LIS vendors, but neglecting to communicate across boundaries of separate concern will keep systems in place that no longer have much justification and are easily changed.

A closer look at the benefits of autovalidation
Administrators sometimes become so focused on a process itself that they lose touch with why they are doing it. The work and expense of implementing autovalidation can seem intimidating in a competitive environment where time and money are at such a premium. So it is always helpful to remind yourself of the comprehensive benefits of autovalidation that justify the effort and up-front cost. Those include:

Elimination of reporting errors. Electronic reporting of autovalidated results eliminates the chance for human transcription error.

Better utilization of trained personnel. With our automated equipment now validating the great majority of the specimens our staff used to validate manually, technologists can better focus on the remaining specimens that require their experience and specialized training. Autovalidation also frees them up to help elsewhere in the lab.

Reduced work intensity. With workload demands so great on the typical lab today, working conditions are constantly stressed if routine results have to be manually validated and entered. The pressure will also increase the chance for human error.

Dramatically reduced TAT. Obviously, an instrument can validate and report results far faster than a human can, and when this pertains to most of the lab’s specimens, the effect on the lab’s overall efficiency is dramatic. Before we implemented autovalidation, our TAT for routine hematology specimens was more than 50 minutes and our TAT for STAT specimens was about 30 minutes. Autovalidation has dropped those numbers to 19.1 minutes for routine specimens and 9.5 minutes for STATs.

Far fewer phone calls. Before autovalidation, our work was constantly interrupted by anxious physicians calling down to the lab to see if their results were in yet. Our decreased TAT has also decreased our time spent giving results over the phone.

Better organization of workflow. When all results are manually validated, technologists have to sort through the instrument printouts to find the specimens that demand special attention. Autovalidation is capable of separating autoverified specimens from those that aren’t, so medical technologists always know which specimens require their focus.

Faster delivery of patient care. With faster TAT, care can also be delivered to patients more quickly. This is especially important in testing ordered by the intensive care units, outpatient clinics, and operating rooms. A related benefit is that partial autovalidated results such as the hemoglobin or hematocrit can be expeditiously delivered to the physician even when other values such as the WBC or platelet count have to be manually verified by technologists.

Uniform, consistent reporting. Autovalidated reporting is free from human variability, and thus easier to interpret. It also helps make the workflow in the lab more predictable and easier to manage on a day-to-day basis.

In summary, if the rationale for our existence is patient care, how can we ignore an innovation that improves it? If our goal is to stay afloat in a fiercely competitive environment, how can we turn our backs on productivity and efficiency gains that are already becoming mainstream? For larger volume labs today, the choice to employ autovalidation is inevitable. The only remaining questions are “when” and “to what degree?” The answers should be “very soon” and “as extensively as possible.”

Gerald M. Davis is senior clinical technologist in clinical hematopathology at the University of Michigan Hospitals (Ann Arbor, Mich.)