By Mary V. Barba, MT(ASCP)

 Reduced budgets, staffing, and reimbursement—coupled with increased regulations and physician expectations — have forced laboratory personnel at all levels to seek nontraditional approaches for meeting customer expectations. Instrument selection is no exception in that laboratory personnel must adopt new approaches when selecting new products.

Although purchasing decisions once were made by a limited number of decision-makers, today most labs create a special team to identify, evaluate, and implement new instrumentation and assays. Although this approach has proven effective, it alone cannot ensure success. According to Robert Michel, editor of the Dark Report, productivity, error reduction, and labor are the key areas of focus for laboratories today.

For many years, a large midwestern hospital lab used a dry chemistry analyzer from Ortho-Clinical Diagnostics, Inc. (OCD). When their contract was due to expire, they put together a lab committee for assessing new analyzers with the goals of decreasing costs and consolidating workstations. The team represented all areas affected by the instrumentation selected, including technologists from all three shifts, phlebotomy, information systems, finance, administration, safety, and pathology.

To expand the lab’s options and consider all available technologies and approaches, the team looked at all major vendors, including OCD. All had automated analyzers that they believed met basic quality needs for results, but they chose a wet system based on price and the ability to consolidate more testing onto one platform. Open channels were also important to provide the flexibility to add new methods as they are developed.

However, after working with the wet system for 12 months, the hospital decided to cancel the contract and return to dry chemistry from OCD. According to the core lab manager at the hospital, everyone involved, including technologists and vendor representatives, had worked very hard to make the new system work. But in the end they found that the switch from dry to wet had increased both operating costs and turnaround times. This was a tough learning experience and one that this facility, which elected to remain anonymous, decided to share with others who are considering new instrumentation.

Selection Criteria
The decision to utilize a wet system was made on two levels: financial and operational. On the financial end, a cost per reportable result (CPRR) contract was considered most desirable as it guaranteed that the lab would pay only for tests that were billable and used to generate revenue for the hospital. Controls, calibrators, and accessories were included with enough reagents to report out 1.7 million results per year. The price quoted was 8% lower than they had been paying with OCD. However, the committee did not evaluate the cost of shipping and extra labor hours required to operate the wet analyzers. In addition, the space required for reagent storage mandated ordering every month. Because of the weight of liquid reagents, the lab spent $14,000 in shipping charges alone the first 8 months. Water requirements, including drain construction and a twofold increase in water usage, increased costs another $2,000 per year.

In addition, daily maintenance activities were minimal, but the lab committee had not accounted for the complexities of daily start-up: reagent preparation, QC, calibration, and the documentation time required each day to meet regulatory requirements. Lab personnel spent 1 to 1.5 hours each day just preparing the analyzer to run samples. After months, the core lab manager was forced to add a full-time employee to the core chemistry area even though testing volume had not changed. Annual operating costs actually increased by 40%.

In evaluating wet versus dry systems and looking at operations, the team assumed that all the systems were similar with respect to accuracy and precision, and that turnaround time, throughput, and menu were the primary differentiators. Laboratory committee members observed routine operations and interviewed testing personnel during site visits. These visits were limited to first shift only— after completion of early-morning maintenance and calibration procedures.

Once the wet system was implemented, technologists found it more complicated to run and the results less reliable. They received calls from physicians regarding problems with results on routine tests: carryover, cross-contamination, and electrolyte drift. Training took longer than expected as everyone who worked in chemistry had to learn how to calibrate, perform maintenance, and prepare reagents in addition to processing samples. Competency testing became more complex, and the opportunity for errors increased. Turnaround time and morale suffered as a result.

Lessons Learned
The need to benchmark the current system in use was the most significant outcome learned. This hospital lab now has a baseline expectation that future analyzer systems will be measured against. Analyzer efficiency data will not be taken for granted, even with a CPRR. The lab staff found that system efficiency is not so much a measure of reagent and supply costs but a mirror for effective labor utilization and the ability to produce a timely, accurate result. Sometimes simplicity and efficiency mean lower operating costs and higher customer satisfaction.

7 Suggested Steps for Selecting
New Instrument Systems

1 Create a team
– Include a representative from all areas affected by the decision.
– Select backup representatives in case someone is unable to participate during critical events (eg, site visits, implementation, etc).
2 Benchmark current service levels
– Establish a baseline expectation. Identify and quantify current service levels that are expected by the customers served: physicians, nurses, patients, and lab personnel.
3 Visit competitive laboratories
– Select customer sites that are similar to your facility in test volume, special services, and reputation for excellence.
– Visit sites during off shifts to observe high-volume testing with minimal staffing, as well as maintenance, calibration, etc.
– Spend time talking to different stakeholders.
4 Use critical pathways
– Analyze outcomes from site visits and manufacturer claims against expectations.
– Explore the complexity of each analyzer in review. Intervention steps such as calibration, reagent preparation, and parts replacement increase the opportunity for error. Robust methods and instrumentation are critical for high-volume labs with a large number of cross-trained staff.
– Evaluate a system’s flexibility to meet changing needs. (For example, can the analyzer be moved without major construction costs when the lab layout is updated? How quickly will new employees become proficient as the staff starts to turn over?)
– Understand and quantify costs and labor required for inventory management and regulatory documentation.
5 Review the contract
Make sure that critical expectations are outlined in the contract (turnaround time, throughput at peak testing hours, for example).
6 Prepare for training and live date
– Provide ample staffing to handle the unexpected and reduce stress.
– Train personnel in waves, making sure they are familiar and comfortable with routine operations.
– Engage the key operator as much as possible.
– Use a checklist to identify who has been trained on what.
7 Communicate
– Schedule time for staff to get together and ask questions and share issues with the key operator or vendor representative.
– Monitor issues and look for processes that must be changed.

Going live is just the beginning.

Mary V. Barba, MT (ASCP) is a contributing writer for Clinical LAb Products and laboratory diagnostics consultant in Atlanta.