TQM approach improves device review, purchasing

Worker input, acceptance crucial to evaluations

Product evaluation and purchasing strategies that include front-line health care workers as part of a team approach can ease cost-effective implementation of needle safety devices, reports Robyn Gershon, MHS, DrPH, assistant research scientist at Johns Hopkins University in Baltimore.

The patient population at the university hospital includes intravenous drug users with high prevalence of HIV, hepatitis B virus, and hepatitis C virus, Gershon said recently in Orlando at the annual conference of the Society for Healthcare Epidemiology of America. "We have in excess of 20% of all adult emergency department patients walking in the door who are HCV-positive," she told SHEA attendees. "Over time this is translating to increasing risk to our health care worker population. Last year we had 67 known HIV-positive exposures. Nearly 30% of all exposures at Johns Hopkins involve an HCV-known-positive source patient. . . . The first thing we looked for is an engineering control. We wanted to engineer out the problem."

Thus, Gershon and colleagues began a systematic product evaluation process last year using total quality management (TQM) principles to reduce blood exposures by implementing needle safety devices such as needleless intravenous catheters.

"What we had in place was really not a very good system," she told SHEA attendees. "We had people sitting on various ad hoc product evaluation committees . . . who were evaluating diapers as well as safety devices."

The TQM approach emphasizes consensus building, use of visual tools to guide decision making, and involvement of all players in decision making, she explained.

"We took TQM and superimposed it on our product evaluation plan," Gershon explained. "All players on a TQM team are equal. So the end user has just as much impact as a purchasing agent."

The product evaluation team brought in "end users" - front-line health care workers who actually use the devices - and asked them to evaluate six needleless IV catheter designs in simulated use and then fill out a product evaluation form. (See form, pp. 89-90.)

"This brought together about 20 real end users, women and men from ICU, ER, who actually sat there for a couple of hours and used product after product over and over again," she said.

In addition to worker input, the TQM team conducted a cost-benefit analysis, including estimates of the cost of follow-up for a bloodborne exposure, she said.

"At Hopkins right now we have estimated that [an exposure] to a known-positive bloodborne source is costing us roughly $2,000 a case," she says. "That is because it is just so costly to put them on [HIV] postexposure prophylaxis."

The cost of follow-up rises to the $3,000 range if the worker is not immunized for HBV. Indirect costs also mount because workers who do not feel well after taking the postexposure medications take disability leave, she adds.

Another component of the system was the development of a "success index" analysis, which essentially assigns a numerical value - an "index score" - from 1 to 10 based on four criteria. The criteria used at Johns Hopkins are net cost (4 points); feasibility (2 points); acceptability of staff (2 points); and acceptability of administration (2 points). The higher the score given by the reviewer (i.e., strong worker acceptability may be given the full 2 points), the more likely the product or intervention is to succeed. A total score of 7 or higher for a proposed intervention - be it a training program or a needle safety device - signals the green light to go ahead with trials, she said.

Device trials still present problems

Based on the various aspects of the TQM evaluation approach, Gershon and colleagues narrowed the six needleless IV catheters to three. They trialed those in certain hospital areas, and finally narrowed the choice to one product for wide implementation. The approach has its problems, she noted, reporting that some clinicians "pocket" their preferred device rather than the one designated for use in an area.

"It is very difficult to have a device trial, mainly because, as you can imagine, one part of the hospital is using one set of devices vs. another [using a different device]," she said. "The 'cross contamination' that goes on is just a nightmare for us."

The needleless catheter selected was negotiated down to a purchase price that should ultimately save the hospital money, particularly when a 10% to 20% decrease in overall hospital exposures is among the projected outcomes, she added.

"So it is cost-effective [and] we hope it will be safer, certainly," she told SHEA attendees. "The most important thing is the system is designed to feed the data back to the product team that will stay in place. The next device we will be looking at is a needle and syringe set. I would definitely recommend you use a TQM approach to take on this task of product evaluation."