Laurie Rieger, RT(R)(CV), Manager of Cardiovascular Services at the University of Pittsburgh Medical Center East, Monroeville, Pennsylvania (UPMC East), kept checking her email inbox on July 16, 2014. The exceptions committee from the Commonwealth of Pennsylvania was meeting and the decision to grant an exception to perform elective percutaneous coronary intervention (PCI) without open-heart surgery on site for their cardiac catheterization lab at UPMC East was imminent. The decision by the Commonwealth to provide the exception was based on UPMC East’s successful approval for accreditation by the Accreditation for Cardiovascular Excellence (ACE). “I have gotten emails from all our cardiologists and the cath lab team,” Laurie said. “They all say the same thing: did you hear from the exceptions committee yet? Are we approved?”
It is usually much easier to get ACE accreditation for the cardiac catheterization lab. But UPMC East is the first to go through a special application and review process for ACE accreditation after a decision made in January 2014 by the Commonwealth of Pennsylvania. The decision stated that Pennsylvania cardiac catheterization laboratories that wish to provide elective PCI services without on-site open-heart surgery at their facilities must be accredited. The accrediting organization must be state department-approved, with standards at least equal to those of ACE.
The process really began in 2001, when the Pennsylvania Department of Health (PADOH) granted four Pennsylvania hospitals without on-site cardiac surgery an exception to perform elective PCI. The four hospitals were required to meet specific conditions regarding physician operators, quality oversight, and reporting. In 2005, PADOH added the requirement that hospitals requesting the exception participate in the CPORT-E1 clinical trial, a multicenter noninferiority trial. The CPORT-E trial randomly assigned 18,867 patients to compare the outcomes of PCI performed at hospitals without and those with on-site cardiac surgery (Table 1). “Unfortunately, we were never part of the CPORT-E trial. It ended before we opened in July 2012, so we were not able to participate,” noted Laurie. “However, the state did give us an exception to perform emergency PCI.”
In order to participate in the CPORT-E study, each hospital had to perform a minimum of 200 angioplasty procedures per year, develop a formal angioplasty training program to prepare their staff, and establish protocols and policies to assure safe patient care. Enrollment in CPORT-E began on April 7, 2006, and ended on March 31, 2011. In January of 2014, PADOH issued its report, Exception Committee Procedures: Elective Percutaneous Coronary Interventions, (PCI).2 Since the CPORT-E trial closed in 2011, the 17 hospital facilities in Pennsylvania without on-site cardiac surgery back up have been waiting for direction from PADOH. The January 2014 report provides each of the 17 hospitals without on-site surgery backup the opportunity to resume providing elective PCI if they become accredited. Each facility that wishes to continue providing elective cardiac procedures will need to achieve accreditation by December 31, 2014.
In addition, the PADOH report selected ACE to lead the way with accreditation programs for Pennsylvania cardiac catheterization labs seeking a waiver from state regulation. ACE has been providing expert guidance to U.S. state regulatory departments on standard criteria for cardiac catheterization laboratories since it began operations in 2010. ACE accomplishes this by delivering unique programs that help facilities comply with documentation to meet Appropriate Use Criteria (AUC) and elevate their performance by integrating standardized care. The ACE process assists facilities in reducing complexity in order to focus on vital quality indicators. The result is a cost-effective program that mitigates risk.
“We chose ACE because of their high standards, their leadership in the industry and because they are sponsored by the American College of Cardiology (ACC) and Society for Cardiovascular Angiography and Interventions (SCAI),” stated Laurie. “The cardiac professionals at ACE are very helpful, sharing policies, making great suggestions, and providing immediate feedback with good follow-up and communication. I always knew where we stood during the ACE application process.”
“Working with ACE was easy because everything is online. I could fill out part of the application, then come back in two days and pick up where I left off,” continued Laurie. “It was a lengthy process, but not painful. The most challenging part was uploading the films. Uploading wasn’t difficult, but it was time consuming. ACE reviewed the films of 50 randomly selected patients along with the procedures report, and each randomly selected patient had a minimum of 6 cine bursts. That is a quite a bit of data.”
“Having the opportunity to provide elective coronary interventions at UPMC East will benefit the patients in many ways. UPMC East is staffed with highly qualified and experienced cardiologists and clinical staff who will provide patients with the same excellent care that they would receive in the city, with the added benefit and convenience of staying close to home. We anticipate a high volume of patients, said Abdulrab Aziz, MD, Chief of Cardiology at UPMC East. “Up until UPMC East was approved by the state, patients who presented with a cardiac condition needing an intervention would have to be transferred to the Oakland/Shadyside area, which can be costly. Having approval to perform interventions at UPMC East will save money and time for everyone involved.”
“We’ve ramped up our staff to keep our skill levels high while we wait for state approval,” said Laurie. “Our team is comprised of eight cardiologists, four radiologic technologists, four registered nurses, one nurse practitioner, and a manager of cardiovascular services. We have our processes in place to transfer patients when it is needed, and before and after opening the hospital in July 2012, we often practiced ST-elevation myocardial infarction (STEMI) care without letting the team know it was a drill. In addition, since opening in July 2012, we have had four STEMIs present with multi-vessel disease requiring cardiac surgery that we had to transport by helicopter to one of our sister hospitals in Pittsburgh. We had those patients in the Pittsburgh facility operating room and on the table in an average time of 75 minutes. We are ready.”
“We do high-quality work and are here to provide the best care for our patients,” added Suresh Mulukutla, MD, Director of Interventional Cardiology and Center for Quality, Outcomes and Clinical Research at UPMC. “At UPMC, our dedication to quality in the cardiac catheterization lab is exemplified by a highly structured program involving submission of data to the National Cardiovascular Data Registry (NCDR), active physician involvement in data entry and oversight, an internal review process that includes cath film auditing, and a commitment at every level to patient-centered care. The ACE Quality Review process showed us how to successfully integrate all these aspects in an efficient, unbiased manner to assure that we are providing our patients with superior care.”
The Quality Review process is a part of the ACE accreditation program, but it is also a stand-alone service provided by ACE. As a stand-alone service, it is called the External Quality Review program. External Quality Review guides cardiac catheterization laboratories in the same impartial process used for review in the accreditation process. External Quality Review utilizes randomly selected, operator-blinded angiographic case reviews and AUC from the most recent published guidelines. Cath labs benefit from ACE External Quality Review by developing a proactive integrated review program that provides a thorough review of accuracy and quality, with an emphasis on documentation and reporting.
“We don’t know yet what additional reporting will be required by the state; however, we currently provide reporting to the state regarding STEMIs and reporting to various other agencies as well, so we are prepared and have the tools necessary to provide whatever information is needed,” added Dr. Aziz.
In the meantime, the staff at UPMC eagerly awaits PADOH approval. “As a community hospital with no on-site surgery, we are excited to finally be getting approval,” stated Laurie. “We have been working closely with PADOH on how they want to handle elective interventional cardiac procedures. Since opening in July 2012, the state granted us the exception to perform emergency PCI, and we have had excellent results. We look forward to providing local, high-quality care to the patients in our community once again.”
Laurie and the team at UPMC weren’t sure if other regions of the U.S. are going to adopt the PADOH process. However, the team at ACE has been contacted by several states. “There has been great interest in the Pennsylvania program,” said Mary Heisler, RN, BA, Executive Director of ACE. “But so far, no other state has created a mandate like the one we have seen in the Commonwealth of Pennsylvania.”
“The Commonwealth of Pennsylvania is the first state to raise the banner of advocacy for PCI patients who are undergoing elective PCI in hospitals without onsite surgery,” said Bonnie Weiner, MD, MSEC, MBA, FSCAI, FACC, Chief Medical Officer for ACE. “The state of Pennsylvania has a goal to deliver the highest quality invasive cardiovascular care for Pennsylvania residents. ACE is a partner with the state to set the standard for quality in Pennsylvania and throughout the U.S.”
- Aversano T, Lemmon CC, Liu L; Atlantic CPORT Investigators. Outcomes of PCI at hospitals with or without on-site cardiac surgery. N Engl J Med. 2012 May 10;366(19):1792-802.
- Pennsylvania Department of Health. Exception Committee Procedure: Elective Percutaneous Coronary Interventions (PCI). Available online as a pdf download at https://www.haponline.org/Portals/0/docs/Downloads/HAP/HAP-PCI-policy-final-January-2014.pdf. Accessed August 11, 2014.