Vol. 17 Issue 10
QA, QC and the LIS
The advantages to be garnered from a laboratory information system extend beyond bottom line benefits.
Quality control (QC) in a laboratory is arguably the most significant benefit when selecting a laboratory information system (LIS). Most business administrators focus on bottom line benefitsincreased efficiency that allows for fewer full-time employees, a quicker turnaround time and accurate billing via connectivity to the practice management software (via interfacing). Few actually think about the LIS's ability to offer features to automate quality assurance (QA) and ensure patient safety.
Today's LIS should include features that are common to the laboratory regardless of which vendor is chosen. The process of running, recording and reporting quality controls is vital, yet the proper procedures for retaining them can vary depending on instruments, frequency of use and applicable state laws. Some of those basic features should include:
- real-time display of Westgard Rules flags,
- tracking of QC expiration dates (such as those on reagents),
- statistical control analysis on control crossover studies,
- Levey-Jennings graphs,
- turnaround time analysis and
- auditing capabilities to track changes made to QC and patient data made by lab staff.
One of the most important features that your QC module should have is the ability to review QC and provide documentation of corrected actions both in real-time or post-analytical.
Good Laboratory Practices strongly recommend that all QC results be reviewed as they are received by the LIS. However, corrective actions often need to be documented when a control is flagged out of range. The software should be able to report out-of-range tests with corrective actions and eliminate that particular run from the calculations.
When viewing your QC data from the Levey-Jenning perspective, it's critical that your Levey-Jennings report provides the necessary information in a readable format so the technologist is able to easily interpret the data and make the critical decisions from this interpretation. The Levey-Jennings control chart is the QC workhorse of the laboratory and should provide the basic chart view as well as a detailed view that displays the type of Westgard flag that has occurred.
Another important QC feature common in most QC modules is the control graph studies (or graphic displays of control result data over time). These studies can be used for visual comparison of a single test while displaying multiple levels of QC and trending patterns. It should display calculated mean, calculated 2SD (standard deviation), percent coefficient variation and results for each test. It also can be used to compare two different lots for the multiple test levels for crossover studies.
Useful Study Data
While not typically a standard feature of an LIS, storage of linearity studies can be extremely helpful. The linearity study is used to verify that a method will meet/continue to meet performance criteria for the usable reporting range for a test. It is a mathematical QC check on an analyzer for an assay to ensure that the measurable range of the assay for different concentrations will produce valid patient results. It is usually calculated by running a minimum of five samples in triplicate across the entire reporting range and should also provide information about the precision of the test method. The LIS assists the user by completing the calculations and graphs for a linearity study.
Correlation studies are another form of QC that can be used in a variety of waysto compare different reagents, analyzers, methodologies, QC materials and lots of controls. The correlation study will look at the original/known value and compare it to the obtained value. It is a mathematical QC check to ensure that any changes that have occurred are clinically insignificant. It is usually calculated by running a minimum of 20 known samples, in duplicate, across the broadest possible range of values.
A Lean Lab
Laboratory managers face the challenge of creating a leaner laboratory environment. QC modules in LIS software, therefore, must deliver features that help create more efficient productivity through automation. As we look at the LIS landscape, QC modules are evolving and delivering creative solutions to meet the needs of the laboratory. Many manual processes have been ignored by LIS systems in the past but are becoming automated as technology is giving us the tools to do so. Some of the features are document management capabilities, QC data export, automated ordering and rules-based algorithms to alert technologists of QC rules violations.
One of the most beneficial features that we see laboratories embracing is in the form of document management. The ability for an LIS to store documentation alleviates the need for having to archive documents into notebooks. Taking that step to go paperless is a tremendous advantage and is a feature that medical technologists routinely request. An LIS that can accommodate the storage of critical documentation will enable the lab to retain and retrieve data quickly and efficiently, which will greatly enhance both QA and QC. A few examples of what a technologist might store in the LIS include:
- QC package inserts,
- proficiency testing results,
- temperature charts,
- continuing education certificates and
- calibration studies.
Scanning this data into the LIS QC module will allow the lab staff to have all relevant data at their fingertips.
QC data export is also an important function that alleviates the need for manually transcribing QC data to a specific format required by the many QC peer group programs. The LIS can now export your QC data to various types of data formats so they can be shared with the external QC program.
The more advanced LIS packages provide:
1. the ability to automatically order your QC based on parameters such as time, date, lot number and test and
2. the flexibility to create rules to address QC violations. If your laboratory practice runs several shifts, the LIS can order your QC runs as the new shift arrives. Automated ordering also has the logic to order QC based on a panel that has been ordered for a patient. Some tests are not run routinely, so this feature helps automate the ordering process.
For example, if a Monospot test is ordered on a patient, the QC required to be run for that Monospot test can automatically be ordered. You also should have the ability to set up time thresholds for how long that Monospot QC run is relevant. If you set your threshold to be eight hours, you are required to run QC on future Monospot orders after that eight-hour period expires.
Still other rules can be set up based on the QC application that will warn the technologists or hold all patient results until QC has been verified. In many cases, it is common for laboratories to require Westgard rejection violations be resolved before results can be released. The LIS can prevent results from being released until the QC violation has been addressed with the proper corrective action.
To take that a step further, the LIS also can require a manager's approval for the QC in question before releasing patient results. The algorithmic rules technology has now taken the QC rules out of the technologist's head and automated the execution of those rules through the LIS that, in turn, creates a safer and more error-free testing environment.
In the clinical laboratory, the LIS plays a dominant role in QA/QC. While maintaining a profitable bottom line is important, patient safety and care are key. Utilizing an LIS with strong QA and QC functionality ensures all are attained. n
Steward Macis is the director of Products and Support Services at Antek HealthWare.