Best Practices Update: IRB's quality improvement process identifies concerns and fixes problems

QI department is very well organized

Quality improvement (QI) is such an important part of the daily work process at one independent, Midwestern IRB that there are 17 employees on the regulatory affairs and quality improvement team.

"We have a highly efficient and productive team who keep QI as a top priority," says Thomas W. Gibson, RN, BS, director of regulatory affairs and quality improvement at Schulman Associates IRB Inc. of Cincinnati, OH. There are five full-time staff dedicated to quality improvement, Gibson says.

Each year, there is a quality improvement plan and evaluation at Schulman Associates IRB, and these QI reports are presented to the organizational management team with recommendations, Gibson says.

"We have process and outcome indicators for the different teams," he says.

The QI department conducts internal file audits, as well as audits of the web site and IRB meeting minutes each month. "We make sure we have a good representation of all minutes," Gibson explains. "We have an 'opportunities for improvement' database where we look for patterns that could be showing areas of weaknesses."

Gibson and the senior QI coordinator review these at least weekly to make certain they've found every concern that could be made into a QI initiative, he adds.

The QI department produces three different reports each quarter, says Mary Ellen Kramer, RN, BSEd, CPHQ, senior quality improvement coordinator for Schulman Associates IRB. One report involves the IRB's data, including information about the IRB's productivity, processes, and volume of work, Kramer adds.

With the QI department in place, the IRB was better able to handle the major change that occurred when investigators began reporting all deviations from the protocol, including thousands of insignificant deviations. The volume of reports handled by the QI department increased 50-fold between 1999 and this year.

As an example of the IRB's best practices in quality improvement, here are some of the QI activities the organization has employed:

Watch for trends: By keeping track of the IRB's workload each month, the QI department is able to predict future trends.

For example, if the IRB received an influx of new protocols in October of 2007, then the QI department would expect an increase in continuing reviews in October, 2008, Gibson says.

"The QI employees are all cross-trained with different functions, and they can move to meet the needs of the time when the work becomes heavier," Gibson says.

Examine team indicators: Kramer looks at team indicators to see how the teams are doing, including their volume and turnaround time.

"I look at the experience level of the staff, whether they're hourly or salary employees, and I look at some of the information that is obtained because of requests for proposals or requests for information from sponsors," Kramer says. "Some of the information is specifically important to us, including the turnover rate and retention of staff information, and other information is tracked because of requests from sponsors."

The QI office tracks turnaround time for each area of the office's activities. This includes turnaround time for amendment reviews to turnaround time for full board reviews and expedited reviews, Kramer explains.

"Oftentimes you can break down the turnaround time, starting with the receipt to the organization handling it when it's given to a board member," she adds.

"We look for a bottleneck in the processes to make sure we're timely in turning things around, so we don't hold up a study," Gibson says.

When Kramer first began working for the IRB, the office was tracking turnaround time through paper and pencil monitoring. Now there is electronic tracking, and this makes the process much easier, she says.

"Electronically is the best way, but you can still do it by paper and pencil if you're a small company," Kramer notes.

Fixing problems: "Our goal is to have a less than 6% error rate, but I personally aim for less than 3%," Gibson says. "On my team we stay below the 3%, but I have to take that goal through the whole organization and monitor things closely enough to determine the accuracy or error rate."

Kramer prefers to call it a 97% accuracy rate. "I think it encourages staff to do even better when they see a report on their accuracy rate," she says.

Share QI data: The IRB staff and board are involved in QI processes in a variety of ways. For instance, there is a staff quality improvement committee that includes representation from the board, management, and IRB staff who see QI data periodically, Kramer says.

Then the entire IRB staff sees QI data during the quality week in which quality improvement is celebrated and promoted from a Sunday to a Saturday.

QI data are posted on cubicle and office walls and in the hallway. It's divided by team and also reflects the board's work.

Since there is so much QI information, each year the QI department selects some specific data to display.

"One year it will be all about team indicators, and another year it will include board information, and another year it will be about QI initiatives," Kramer says. "We try to focus on a certain area of the QI report, which has three different parts."

Keep a QI activity summary report: The QI office has developed a QI activity summary report, using some existing forms and modifying it to suit the IRB office's purposes.

The first page and section of the report asks for a summary of the activity, type, goal, and benchmark. Then there's the question, "How was this identified as a meaningful activity?"

"On the first page we want to list why the activity is meaningful," Kramer says. "It could be that the study has a high volume or is high risk or is problem prone."

Or it could be as simple as one team is using one term to describe a process, and another team is using the same term differently, she notes.

The form has a checklist of processes and other items that need to be checked if they pertain to why the activity is meaningful.

These include submission, pre-review, board, approval, amendment, product safety, recruitment, regulatory affairs, quality improvement, project management, IRB coordinators, document management, information technology, accounting, legal, reception, human resource, and others.

"This form describes the problem," Gibson says. "The whole first part is the activity and why we're doing it and what is the goal."

The second section of the report asks for a summary of measurements, results, analysis, and actions.

"After you've done the measurements for the process and determined the sample size and methodology, then you start doing measurements and put interventions into place, determining how long you want to do this project," Gibson explains.

For example, there could be a new policy put in place and it's measured every six months, using the same methodology to see if the interventions have caused any changes, Gibson says.

There are pages in the QI activity summary for data re-measurements.

The QI activity summary does not need to be applied to all QI issues.

"When we have things that we can resolve in five minutes by switching things around then we don't need to go through this whole process," Gibson says. "This is for major initiatives or issues involving studies that have a high volume or high risk or are prone to problems."

Complicated QI issues also might require the completion of the QI activity summary sheet.

"With the QI activity summary, maybe there are some problems that cross several teams, or these could be a big enough issue that it would need to be a quality improvement study, which is more like a root cause analysis," Kramer says.