Strategies for honing QI in budget process
Strategies for honing QI in budget process
Experience, details matter
One important strategy for improving a clinical trial site's quality in research and process is to make certain all employees handling budgets are well trained and experienced, an expert says.
"Where we get into trouble from an academic perspective is when you have someone who is less experienced in preparing budgets and reading protocols," says Tesheia Johnson, MBA, associate director for clinical research at the Yale School of Medicine and chief operations officer for the Yale Center for Clinical Investigation.
"The budget that's given to us by a clinical research organization (CRO) or a pharmaceutical company often times doesn't fully account for the other costs of doing research," Johnson explains. "They might have listed $25 for processing a blood sample, but when you read through the protocol, you see there's an intensive preparation time associated with it."
For instance, the blood sample might need to be spun down, and then someone will need to spend time preparing it both before spinning and then afterward when packaging and shipping it, she adds.
"This process could take three hours, and that doesn't add up to $25," Johnson says. "These details are the kind of thing you could glean from reading the protocol, and they're the kind of things you need to account for in the budget."
Another detail involves what is designated standard of care.
Sometimes sponsors will designate a particular procedure as standard of care when the reality is that only the physician can make this determination, Johnson says.
"There is no national standard for what is standard of care for a particular individual," she adds. "So sometimes the sponsor will designate something as standard of care where it's not a standard of care, and Medicare could deny the charge."
Another problem involves invoicing omissions and errors.
For example, each time there is an adverse event that requires a procedure, there is a health care charge that some sponsors will consider a charge that should be invoiced, Johnson says.
"Sponsors say academic sites aren't very good at tracking those events," Johnson says. "They don't track what needs to be invoiceable services."
This omission usually occurs because of a flaw in the invoicing process. For instance, the person who documents the adverse event will need to report it to a financial person, who will then transfer the information to the person who handles invoices. If someone doesn't complete their part of this transfer of information, the invoice isn't sent out and the research organization does not recoup the money spent on the procedure, she explains.
"So sponsors count on that mistake," Johnson says. "When CROs present information to pharmaceutical companies, and study sponsors talk about ways to cut costs, they decide to change these kinds of items to an invoiceable line item because not all centers have a good procedure for tracking those charges."
Previously, this might have been included in a budget, but when you change it to an invoiceable charge, you've put the onus on the site to have someone track it and send out the invoice, she adds.
The Yale Center for Clinical Investigation solved this problem by putting a tracking log process in place.
"For every study, we build an individual tracking log," Johnson explains. "Then on a weekly basis our coordinators track information."
Soon this process will be automated through an electronic clinical trials management system, she adds.
"But until then we have a home-grown tracking system where coordinators fill it out according to their studies," Johnson says.
The system also keeps track of milestones from a billing perspective, and it turns those over to financial people to summarize on behalf of investigators, she adds.
"It's a complicated process to make sure you're paid for all those events," Johnson says.
But the alternative is to miss reimbursement for some research work.
The Yale Center for Clinical Investigation has invested time and resources into making quality improvement changes to its budgeting and financial process since receiving a Clinical and Translational Science Award (CTSA) from the National Center for Research Resources of the National Institutes of Health (NIH) three years ago, Johnson says.
"We started looking at this based on one of the strategy priorities of CTSA, which is to improve clinical research management," Johnson says. "Also, the financial pressures from the economic recession has forced us to look at our own financial issues."
The institution's own goals to be one of the top research institutions for clinical and translational research also has encouraged the organization in making changes, she adds.
"The medical school recognizes that we need to have an infrastructure in place that supports our faculty doing their best in clinical and translational studies, and so the medical school invested in improving the clinical research infrastructure," Johnson says.
One important strategy for improving a clinical trial site's quality in research and process is to make certain all employees handling budgets are well trained and experienced, an expert says.Subscribe Now for Access
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