January 1, 2005
Bringing New POCT Equipment on Board
Advance for the Administrators of the Lab – Vol. 14, Issue 1
POC Connectivity Concepts, by Matthew T. Patton

When point-of-care testing (POCT) is to be implemented on a large scale—involving multiple clinics and units or even multiple hospitals—pre-planning by multidisciplinary teams is essential. Equally important is to incorporate instrument vendor expertise into the training process. Involvement at all levels can help ensure that labs stay in regulatory compliance and remain competent users of POCT equipment.

Staff Involvement

When dealing with quality control for employees new to the instrumentation, Lou Ann Wyer, MT(ASCP), clinical specialist, POCT/QM, Sentara Laboratory Services, Norfolk, VA, tells ADVANCE that her facility conducts precision, reportable range or calibration validation and method comparison studies during the pre-planning phase. Statistical analysis is performed on each set of data and the method's performance is approved prior to implementation.

At Sentara, POCT staff and, occasionally, vendors, provide initial training to POCT operators. Training sessions are scheduled with input from nurse managers and are conducted outside of the patient care workplace. "If staff have an active role in the decisions for new instrumentation and work processes, it will lead to a win-win situation for all," Wyer says.

Part of the training involves curbing errors such as misidentification of specimens. To simplify identification, Wyer says POCT operators have barcoded wristbands and operator identification badges. She suggests that if a facility has not yet converted to barcoded bands, the lab should be involved in the selection process to assure bands suffice for POCT technologies—another way to incorporate staff into the training and decision-making process. "It is wise to pilot or trial several wristbands to ensure they work as anticipated," Wyer says.

To stay on top of new testing technologies and regulations, she recommends that laboratorians read journals and visit Web sites, join professional organizations and participate in audioconferences and Web casts. The information that these sources provide, Wyer says, can help POCT users stay abreast of where POCT regulations are headed.

"With more instruments available for POCT, we must be diligent and investigate thoroughly for the benefits and efficiencies they will bring to the POCT program," Wyer says. "We must continue to ask and expect vendors to produce methods that are as precise and accurate as clinical laboratory instrumentation. POCT programs must have mechanisms in place to prevent patient care units from ordering any type of instrument without laboratory approval. Monitoring multiple devices for the same analyte can be a nightmare."

Planning Is Key

Like Wyer, Diana R. DeHoyos, BS, MT(ASCP), POC coordinator at the University of Texas Medical Branch at Galveston, works with staff during the pre-implementation phase of POCT.

She notes that if instrumentation is implemented on a large scale where multiple clinics and units or multiple hospitals plan to adopt the technology, then pre-planning by multidisciplinary teams is key. She explains that incorporating vendor manpower into the roll-out is "in the [lab's] best interest."

On a small scale, the training process at her facility is coordinated and arranged by POC staff directly with the area nurse manager or a similar supervisor. This facilitates scheduling, because training often calls for taking personnel away from their patient care duties and use of unit space.

On another note, DeHoyos stresses the importance of error prevention in providing safe, quality POCT results, and that barcoding can aid in positive patient identification and outcome. And to guarantee safety, she agrees with Wyer that staying abreast of new technologies and regulations is crucial.

Help From the Vendors

Ron Blasig, director of Marketing at Abaxis (Union City, CA), provides vendor input on the essentials of training on POCT instrumentation, noting that POC personnel train nursing staff on new technologies offered by his company. Abaxis is the developer of Piccolo, a portable, broad-menu clinical chemistry analyzer designed for near-patient testing.

"Training is the same, whether it is a physician, lab director, lab technologist or nurse," he says.

To stay abreast of new regulations, Blasig attends conferences on CLIA regulations and updates. "I work hand-in-hand with COLA to provide information on how the Piccolo complies with new regulations. Abaxis provides customers who purchase a Piccolo with a guide to lab quality compliance," he explains. This document details a step-by-step procedure on how to meet the new regulations for non-waived testing with backup for compliance using approved NCCLS guidelines.

In this respect, Blasig says he is able to provide training tips and help customers stay compliant.

Regardless of the scale of the implementation, however, vendors often provide helpful training, competency assessment tools and materials that complement existing ones, while facilitating and standardizing implementation of new technology. Some vendors offer the ongoing service of tracking compliance with selected regulatory requirements as an incentive.

Matthew T. Patton is editor of ADVANCE for Medical Laboratory Professionals.