Large laboratory organizations with many departments find it difficult to effectively allocate responsibility for quality control. While a centralized, top-down approach can simplify regulatory compliance, distributing responsibility for calibration to individual departments has distinct advantages.
ARUP Laboratories (Salt Lake City, UT), a national clinical and anatomic pathology reference laboratory, recently decentralized pipette quality control across its departments to great success. Working closely with Artel (Westbrook, ME), a provider of liquid handling quality assurance technology, the lab implemented a standardized process for over 1,500 pipettes used in 71 departments. The Artel PCS® Pipette Calibration System and associated Artel Pipette Tracker™ software were used to facilitate this process. ARUP also formed an Artel Users Group drawing representatives from participating departments to continually ensure that standardized protocols were implemented with input from the entire organization.
By putting into practice rigorous quality standards through this standardization initiative, ARUP realized significant economic benefits. This outcome was achieved by reducing the number of tests that had to be rerun due to known or perceived pipetting error, thus minimizing wasted time and materials.
Based in the University of Utah Research Park in Salt Lake City, ARUP offers more than 2,000 clinical tests and test combinations, ranging from routine screening tests to highly esoteric molecular and genetic assays.
As with any medical laboratory, pipetting is a critical component of ARUP’s operations. Regular pipette calibration has always been an important part of their quality control system. Because many of the tests are extremely sensitive and results often determine patient diagnoses and treatment regimens, accurate and precise pipetting, especially when working with low volumes, is crucial for the success of the laboratory.
ARUP was an early adopter of the PCS from Artel for calibrations in its reagent production lab. As the organization grew, the reagent lab assumed responsibility for calibrating many of the pipettes used organization-wide. However, the reagent lab often confronted a backlog of pipettes and experienced challenges in handling uneven workflow.
“Since most departments specified quarterly calibration intervals, calibration requests would peak and overload the lab at the end of each quarter,” said Jeff Howard, ARUP Quality Specialist.
Another difficulty with this centralized approach was that, although the actual calibration was performed by the reagent lab, each individual department was responsible for the cleaning, maintenance, and calibration frequency of its pipettes as well as setting tolerance limits associated with different pipette types. As ARUP expanded and its pipette population grew, more challenges arose. There were discrepancies in the calibration procedures between different labs. Different tolerances, data requirements, naming conventions, and standard operating procedures (SOPs) often would be associated with the same pipette model. Users of a pipette could set their own preferences, potentially leading to the same pipette being entered into the data tracking system two or three times. This duplication led to inefficiencies and hampered ARUP’s ability to garner useful data from the pipette tracking system.
To remedy these issues, ARUP decided to decentralize the pipette calibration function and install multiple PCS instruments throughout its facility, which allowed each functional department to assume responsibility for the calibration and maintenance of their own pipettes.
“Artel’s technology was critical in facilitating this changeover,” added Howard. “It’s enabled us to standardize pipette quality procedures across our entire organization.”
To facilitate and oversee its decentralized approach, ARUP created an Artel Users Group, bringing together quality control staff from across the organization. The group spans all levels of the organization: lab technologists, quality specialists, and group managers.
The Users Group began by standardizing calibration methodology, frequency, and tolerance limits. For example, a particular pipette with a range of 20 – 200 µL could have different calibration procedures associated with it based on the department in which it was used. Now, following Users Group standards, the policy is set: the pipette is calibrated quarterly at three volumes (20 µL, 100 µL, 200 µL) with defined tolerance limits for accuracy and precision. The group also helped standardize how the data tracking system was used. Artel’s Pipette Tracker™ software is designed to manage quality control of an entire population of pipettes. It schedules calibrations, automates data collection during calibrations, and produces all documentation for regulatory compliance. The software also enforces the calibration methodology and tracks who is responsible for calibrating specific pipettes.
By standardizing calibration methodologies and procedures for each pipette, the group eliminated duplications and redundancies, reducing the data in the system by two-thirds. The group also standardized how the system was used so that each pipette now has a defined nomenclature, specific serial number, and specified SOP.
The Artel Users Group streamlined the entire quality process, making management of calibration data more efficient. Howard noted that “by implementing standardized policies across the board, we were really able to speed up the entire system, making it more effective and productive over the long term.”
One advantage of assigning calibration responsibility to the departments that actually use the pipettes was that it made ARUP more aware of the need to train users in proper pipetting technique. Since the PCS provides immediate feedback on pipetting performance, ARUP could observe errors in accuracy and precision based on variability in technique. The organization decided to create a training program to ensure that all pipette users were proficient in pipetting.
To streamline this training process, the Users Group is designing an online tutorial in pipetting technique that will be mandatory for all technical staff. The tutorial combines information from Artel’s Pipette Quality Management Certification seminar, which ARUP recently participated in, and the organization’s own internal SOPs.
The online tutorial is merely the first step in ARUP’s training initiative. The organization also plans to implement a wet lab training class that will merge elements of Artel’s training program and the best practices currently in use at ARUP. All incoming technical staff will be required to learn about and practice proper technique and receive hands-on experience using the PCS. The PCS is uniquely suited for training staff because a trainee can perform a 10-data-point calibration, complete with documentation, in less than three minutes. This quick feedback allows trainees to see the positive impact of minimal changes in technique.
“Even for technical staff who don’t use pipettes daily, merely having them go through this training significantly raises awareness about the relationship between pipetting technique and quality,” said Zachary Wilkey, Quality Specialist at ARUP. “That fits with the overall goal of the Artel Users Group: to standardize our quality procedures throughout the organization and make quality a priority.”
Rigorous quality procedures is the economic benefit associated with a high degree of accuracy and precision in liquid delivery operations. “The Users Group’s emphasis on standardizing quality not only ensures data integrity, it also saves us money over the long term,” said Howard.
If pipettes are properly calibrated and operators are well trained in proper technique, there are fewer run failures over time. This minimizes material waste – such as expensive solvents and reagents – and also saves time and labor allocated to re-running tests.
“Quality is a goal in its own right,” said Howard, “but there is also a strong business case for maintaining high standards. The Artel Users Group is executing that mission at ARUP.”
ARUP Laboratories is a national clinical and anatomic pathology reference laboratory and an enterprise of the University of Utah and its Department of Pathology. With 2,700 employees, ARUP offers more than 2,000 tests and test combinations, ranging from routine screening tests to highly esoteric molecular and genetic assays, for patients throughout the country. Rather than competing with its clients for physician office business, ARUP chooses instead to support clients’ existing test menus by offering highly complex and unique tests, with accompanying consultative support, to enhance their abilities to provide local and regional laboratory services. ARUP’s clients include more than half of the nation’s university teaching hospitals and children’s hospitals, as well as multihospital groups, major commercial laboratories, group purchasing organizations, military and government facilities, and major clinics. In addition, ARUP is a worldwide leader in innovative laboratory research and development, led by the efforts of the ARUP Institute for Clinical and Experimental Pathology®. Further information on ARUP Laboratories can be found atwww.aruplab.comDownload Now