Cath Lab Oversight: Is Peer Review Enough?
Due to recent highly publicized controversies of alleged over-stenting, state and federal authorities have begun to question the peer review process in cath labs. As a result, professional societies are exploring a new accreditation process, but some providers fear the time and costs that this could entail.

Peer review process

“In cath labs throughout the U.S., we need to eliminate some of the common variations that occur with the internal peer review process from hospital to hospital,” says Mark A. Turco, MD, director of cardiac and vascular research at Washington Adventist Hospital in Takoma Park, Md., which performs approximately 25 to 30 cases—diagnostic and interventional—daily in its five cath labs.

At Washington Adventist, the cath lab director chairs the internal peer review process, in which a representative group of cath lab operators reviews the cases on the first Friday of every month. “Performance measures are quality markers that drive much of the reviews, and our staff documents deviations from appropriate performance,” Turco explains. “It is critical that the internal peer review committee not only reviews adverse patient outcomes, but also the appropriateness of procedures—what was done, why it was done and how it was done.”

In an effort to avoid bias at Washington Adventist, cardiology partners cannot review each other’s cases. Also, the provider has embraced the growing trend of an oversight peer review committee, whose multidisciplinary members are appointed by the hospital’s medical executive committee.

However, cath labs provide diverse services and for varied patient populations, so the make-up of each lab is different. “Most of the cardiologists who service our facility are privately-based,” explains Roshan K. Mathew, MD, medical director of the cardiac cath lab at Owensboro Medical Health System in Greenville, S.C., which performs about 2,000 cath lab procedures annually with 11 cardiologists—nine of whom are interventionalists. Owensboro has established a cardiology services committee, which consists of all the local cardiologists, and a chair and a vice chair. Independent of the committee, the medical director runs the cardiac cath lab.

Initially, at Owensboro, peer review was conducted by the committee, but that has since been changed, so there are “no inter-group conflicts,” says Mathew. Now, the peer review process is conducted by two cardiologists, the medical director, the chair of the cardiology services committee, along with three independent physicians—from internal medicine, the emergency department and surgery—who track and trend the National Cardiovascular Data Registry (NCDR). This process falls under the quality department, which has a separate chair who assigns the members of the review process. The medical director only deals with “dramatic issues,” while the committee votes on most of the considerations.

“The process mainly tracks complications,” Mathew says. “A quality review of individual operator usage is very difficult to assess, and we are currently seeking a better evaluation method. The problem with tracking complications is that high-volume operators will naturally have higher complication rates, but it is not necessarily reflective of technique.”

Most practitioners and administrators concur that the current systems in place aren’t perfect. “In an ideal setting, an unbiased committee would track independent quality assessments, along with complications, which would include the evaluation of FFR [fractional flow reserve] and intravascular ultrasound usage,” Mathew says. “Inevitably, we need to make tough decisions about whether physicians are performing appropriate procedures, as established by the clinical guidelines.”  

Turco stresses the importance of documentation, potentially employing a pre-cath checklist that clearly states the reasons for moving forward with a procedure.
However, some still are seeking external oversight to ensure the cases are being handled and reviewed appropriately.

Society accreditation = excellence?

The Accreditation for Cardiovascular Excellence (ACE), a nonprofit initiative supported by the Society for Cardiovascular Angiography and Interventions (SCAI) and the American College of Cardiology (ACC), was formed approximately five years ago in response to CMS' stipulations about accreditation for institutions performing carotid stenting. Approximately one year ago, ACE undertook the goal of providing accreditation for all invasive and endovascular procedures, and will add congenital and structural heart disease procedures this year.  

“A proper accreditation initiative, which should be physician-led, needs to maintain transparency and consistency, so all facilities are judged by the same standards. Much of the criteria to assess these physicians comes from training and competency documents, as well as data from clinical trials,” says Bonnie H. Weiner, MD, MBA, board chair and chief medical officer at ACE. “We not only examine staff credentialing activities, education activities and staff expectations, but we also assess the patient selection process, along with appropriate patient outcomes.” To establish thresholds for the cath lab and PCI procedures, ACE will utilize clinical guidelines, appropriate use criteria and quality assurance documents.  

Claims vs. clinical data

In reviewing facilities, ACE employees examine clinical data as opposed to claims-based data. As a result, Weiner says the committee can compare like-facilities, and understand why there may be similarities or differences. Many state and federal authoritative bodies employ the use of ACE. “In our current environment, state-run bodies will not likely be able to pull from clinical data, since those data are controlled by the societies,” she says.   

Turco also stresses that the types of data used to assess hospital and individual performance is “incredibly important. Administrative or claims-based data serve to examine the bigger picture of utilization; however, it falls short when comparing one hospital to another or one operator to another. There is no risk adjustment nor are events adjudicated. Pure administrative data are just a set of numbers not taking into account any hospital-to-hospital or physician-to-physician variability. Much of medicine is in a gray zone and not black or white. Clinical data allow one to look at some of the important variables and apply those to data reports that will be much more reflective of what patients, hospitals, physicians and legislative bodies need to see and act on.”

In fact, Shahian et al found that cardiac surgery report cards using administrative data are problematic compared with those derived from audited and validated clinical data, “primarily because of case misclassification and non-standardized endpoints” (Circulation 2007;115:1518-1527).

Cost considerations

For the ACE process, hospitals are currently incurring the costs. The final price point for the cath/PCI component has not been finalized, as the committee is attempting to make the process customizable based on the services that the facility provides.  

Yet, Mathew expresses concern about the costs involved and doesn’t think an additional level of accreditation process is practical. “Hospitals should be internally working to make their results more transparent, as opposed to presenting another, potentially expensive, external hurdle for the hospital to jump over,” he says. “The cost and time required to adhere to a new accreditation could be tremendous, and it’s unclear whether U.S. cath labs should or will undertake the process.”

On the other hand, Turco speaks to the FTE costs incurred by the provider attempting to collect and track data. “To offset the costs, we need to examine how providers that meet certain quality measures can attain a step-wise increase in reimbursements,” he says. “If we want to see an increase in transparency and an improvement in quality, we need to find a way to subsidize the hospitals making those strides without it being a burden."

Achieving ACE accreditation may help assuage the payor-provider process. “We hope to work with some of the payors to be able to use accreditation as a mechanism for reducing the administrative load on facilities from a reporting standpoint,” says Weiner. “If the payors accept ACE accreditation as valid oversight, then it would streamline the process for their facility and meet payors’ requirements in order for them to be reimbursed.”