In a large laboratory with diverse departments, it can be challenging to strike an appropriate balance between centralized versus decentralized responsibilities for quality-control (QC) functions such as instrument calibration. Process centralization theoretically supports a more standardized approach and can simplify regulatory compliance, while decentralization gives each department an opportunity to maximize quality and efficiency in its particular environment.

Recent changes in the pipette-calibration process at ARUP Laboratories illustrate an instructive case in point. ARUP has switched from a centralized program to a decentralized approach, in which individual departments take full responsibility for all aspects of pipette performance. This change was designed to further enhance the quality and integrity of our clinical test results, and to ensure regulatory compliance, while also enabling us to make more efficient use of our equipment and staff time.

ARUP Laboratories’ Experience with Centralized Pipette QC
For years, ARUP Laboratories satisfied its requirements for pipette calibration with a centralized calibration approach. Because of its comparatively large size, the skills of its staff, and its close functional relationships to other departments, our reagent lab calibrated many of the pipettes used throughout the organization.

ARUP receives about 26,000 patient samples per day.

While actual pipette calibration was performed via this “centralized service,” each department was still responsible for the cleaning and routine maintenance of its pipettes, as well as for establishing appropriate tolerance limits for the accuracy and precision of each type of pipette used. Each department also determined its own calibration frequency. Our organizational guidelines suggested a quarterly calibration interval for pipettes. Where accuracy and precision were especially critical, pipettes were calibrated more frequently, while pipettes not used for quantitative purposes might be calibrated less often.

From the standpoint of ensuring compliance with our quality-system regulations, the centralized program worked well. As our pipette population grew, however, some unanticipated concerns began to arise. For example, several of the technicians who were performing the bulk of the calibration work began to develop repetitive-motion injuries. This was indicative of the increasing workload that pipette calibration placed on these few individuals.

Another problem was an inherently uneven workflow. The number of pipettes to be calibrated invariably peaked near the end of each quarter, because most departments specified a quarterly calibration interval for their pipettes. Despite various attempts to smooth out the schedule, the calibration workload and the turnaround time for calibration inevitably increased from a few days to up to a week during these periods.

But perhaps the most noteworthy side effect of our centralized program was a diminishing degree of attention to the care, cleaning, and routine maintenance of pipettes. It seemed that our collective mindset regarding the ownership of pipettes and the corresponding sense of overall responsibility for them had waned due to the fact that the reagent lab was responsible for the calibrations.

Rethinking Centralized Calibration
In September 2002, ARUP convened a small steering committee to discuss how we currently calibrated our pipettes, and the possible opportunities for improvement offered by making some changes. Managers representing several departments, the reagent laboratory, our technical director of operations, and I, as compliance coordinator, were on hand.

We weighed various alternatives, from outsourcing the pipette QC process to decentralizing it completely. The former would simplify matters, but it had distinct disadvantages. It would be more costly than our current program, would involve longer turaround times than we were used to, and it would take the ability to directly ensure quality out of our hands. Also, outsourcing could not address, and in fact would likely exacerbate, our workflow issues with respect to cleaning, adjustment, and/or recalibration of failed pipettes.

Full decentralization of pipette QC was more appealing from the start because it presented an opportunity to further enhance the quality of the entire process. Our goal was not only to ensure that our pipettes were calibrated, but also to evaluate pipette performance in the same environment and by the same people who use the pipettes each day. In this way we hoped to check the pipettes, the pipette tips, and the pipetting technique of the staff that work with pipettes, all at the same time.

Equipment Decisions
In evaluating our resources and options regarding returning full ownership of pipette QC to individual department laboratories, a key element would be selecting the technology to use in order to implement the program.

Historically, the reagent laboratory, where a large portion of pipette calibrations had been performed, used the ARTEL PCS® pipette-calibration system. The ARTEL PCS uses a dual-dye photometric method to measure the dispensed volume of a pipette automatically. The PCS method is immune to environmental sources of error and was considered ideal for the job of decentralized pipette calibration because environmentally controlled facilities are not required for accurate volume measurements. The PCS is designed for routine benchtop use, and was perceived by our reagent lab staff as fast, accurate, reliable, and cost-efficient. By using the PCS technology and linking the various department laboratories to a central database using ARTEL Pipette Tracker™ software, we could capture the calibration data from each department and archive the calibration data electronically. In addition, we could automatically compare the pipette calibration results to preset tolerance limits that we established together ahead of time so users would obtain an immediate pass/fail status.

The Best of Both Worlds
We determined that four PCS systems could satisfy all of our requirements across ARUP’s entire population of more than 1,000 pipettes.

Our desire to make our individual departments responsible for their own pipette calibration, while at the same time ensuring company-wide standardization, was greatly facilitated by the fact that multiple ARTEL PCS instruments, interfaced to PCs running ARTEL Pipette Tracker software, could be linked over an existing Intranet and set up to share a centralized database. This capability enabled us to address key regulatory requirements and simplify the process and procedures for gathering, storing, and distributing compliance-related data across the organization.

We created our pipette-calibration network by strategically locating the four ARTEL PCS instruments near those departments that maintained the largest numbers of pipettes. These PCS instruments were linked to a common database via a central server. Now we could have the best of both worlds: full departmental responsibility for pipette QC, plus a central, companywide data repository covering all performance data and regulatory-compliance information for our entire pipette population.

Stronger Company Guidelines
In line with our evolving plans to decentralize pipette calibration, we felt it would be essential to create a stronger set of standards, company-wide guidelines, and policies for pipette QC. Key areas addressed included:
    • Standards for the calibration of multichannel pipettes;
    • Calibration frequency in relation to frequency and type of use;
    • Use of the ARTEL PCS instrument rather than a balance for calibration of small- volume pipettes (below 200 µL), for optimal accuracy and precision; and
    • Guidelines concerning standard models of pipettes, to reduce the amount of spare parts and tools needed for pipette maintenance.

Departmental guidelines continue to be essential for each specific laboratory environment, while stronger company policy serves to enforce and support a departmental focus on compliant, effective QC.

Our Training Solution
ARUP as an organization places great emphasis on education and training, and we readily embraced the challenge of training/retraining our staff to handle benchtop pipette calibration. Again, our goal was to leverage decentralized pipette QC by having users calibrate their own pipettes in situ and thereby obtain feedback via the PCS, as a further training and evaluation tool. The first step toward this goal was to revise the companywide standard for pipette QC, along with supporting procedural documents. The steering committee drafted an outline of the QC process, a pipette cleaning/maintenance standard operating procedure (SOP), an SOP document for using the ARTEL PCS with ARTEL Pipette Tracker for pipette calibration, and a revised SOP on performing calibration using a balance, which we do on high-volume pipettes. We based our training program, which encompasses not only calibration but also cleaning and basic maintenance, on these documents.

The need for training extended into every laboratory in the organization. Our education department developed a comprehensive online training program and documentation consisting of online courseware to supplement the procedural documents just described. In addition, training modules were created and provided to departments detailing training requirements, objectives, and tests to document skills and proficiency. Our approach to rolling out the training proved to be smooth and efficient. First, our education department held a training seminar in which one or more training specialists from each department were trained. Next, training specialists trained lead technicians, QC specialists, supervisors, and others, who, in turn, trained the staff who would be responsible for the care and calibration of their pipettes.

Pipette technique training was already well established at ARUP, and we have been using the ARTEL PCS as the basis for this program in the reagent lab for some time. The PCS provides almost immediate feedback to the pipette user concerning pipetting performance, and this is invaluable when teaching proper pipetting technique. Staff experience with the PCS instrument made it that much easier to introduce basic information on pipette calibration during our introductory technique training. We feel that making pipette QC part of our introductory training will help inoculate the company culture and foster wider acceptance of departmental responsibility for pipettes.

Results to Date
ARUP has managed pipette QC in a decentralized fashion since May 2003. So far, the decentralized approach appears to be working out very well. Our various departments are generally enthusiastic about taking full ownership of their pipettes and boosting awareness of proper pipetting technique, because they feel this level of commitment will enhance the accuracy and precision of their clinical test results.

Pipette performance and operator technique are too often taken for granted, and data integrity can suffer as a result. Verification of pipette performance in the working environment by the same users that work with pipettes every day presents the ideal opportunity to optimize these critical elements. The ability to combine training, performance evaluation, pipette calibration, and the generation of compliance and historical documentation in one highly automated system provides a foundation for this quality initiative that ARUP finds ideal from the standpoint of cost, efficiency, and quality.

Michele Fisher is quality lead in the Quality and Compliance Department at ARUP Laboratories in Salt Lake City.