Electrophysiology studies, whether associated with therapeutic procedures or not, have a risk of thrombogenesis. The introduction and manipulation of the catheter alone activates the coagulation cascade, which can cause the development of new clots or the mobilization of pre-existing ones. Increased risk of clot formation varies depending on the site of the procedure, type of sheath used, and procedure duration.1 EP programs need to establish protocols to effectively manage this life-threatening complication of catheter-based coronary procedures. In order to provide best-practice care in this regard, a broad understanding of the mechanisms and current diagnosis of stroke is required.
For a patient who exhibits stroke symptoms during or following an EP procedure, activating an established stroke protocol for immediate intervention and treatment can improve overall patient outcomes and preserve quality of life.
Approximately 795,000 people in the United States will experience a new or recurrent stroke, and the annual cost of stroke care amounts to over $73 billion. Stroke is the fourth leading cause of death and the leading cause of disabilities, oftentimes affecting both the function and quality of life. In order to organize stroke care and improve outcomes, the Brain Attack Coalition, a group of healthcare personnel representing various professional organizations, was founded to develop recommendations for the establishment of Primary Stroke Centers (PSC). These standards were first released in 2000, and then updated in 2011, based on 10 years of experience and advances in medical care and technology.
Today, there are over 800 Certified Primary Stroke Centers in 49 states across the country. In many states, Emergency Medical Services (EMS) protocols mandate that stroke patients be transported to the nearest PSC if one is available. This plan for EMS routing has great potential to impact hospital admissions in many cases, and is oftentimes a driving factor in hospitals seeking official PSC certification.
The Certification Process
The Joint Commission certifies Primary Stroke Centers through their Disease-Specific Care Certification (DSC) process, which was launched in 2003. The Primary Stroke Center Certification program is based on the recommendations of the Brain Attack Coalition and the American Stroke Association, and promotes and recognizes exemplary efforts to improve care for the stroke patient. Five key elements comprise the DSC PSC standards: 1) program management, 2) delivering or facilitating clinical care, 3) supporting patient self-management, 4) clinical information management, and 5) performance improvement and measurement. In addition, there are specific required elements necessary for the Primary Stroke Center designation, as shown in Table 1.
A critical assessment of current services and infrastructure is the initial step in the pursuance of Joint Commission Primary Stroke Center Certification. A commitment to resource allocation and administrative support is essential to not only address the gaps discovered in the assessment, but also to ensure future program viability and success. Also, visible support for the stroke program medical director, along with stroke program committees and staff, are essential to sustain the program. Corazon usually recommends that a stroke steering committee be established to oversee the management of the program and review the quality indicators and resource utilization, and in turn, report successes and challenges to administration.
Program Management & Clinical Care
Evidence-based protocols, pathways, and order sets provide the templates for the delivery of quality care while maximizing resource utilization and providing a foundation for monitoring clinical care. They allow for individualized patient care while promoting timeliness of care and interventions. There must also be a process to routinely review and update the protocols, etc., due to the rapid advancements in medical technology and pharmaceuticals.
Dedicated unit(s) for the care of stroke patients have demonstrated improved outcomes and decreased length of stay. The unit does not need to house solely stroke patients, but should be the unit(s) to which all stroke patients are admitted. Due to cardiac monitoring requirements, almost all patients will begin their acute care hospitalization in an intensive care or telemetry unit.
One major hurdle to overcome in meeting the PSC criteria is the ability to ensure that the same type and quality of care is available 24/7. Hospitals with limited neurological and/or neurosurgical personnel may use telemedicine for patient assessment and therapy decisions and acquire transfer agreements with tertiary institutions that can provide advanced services.2 Corazon believes this is a viable alternative for smaller hospitals or programs unable to staff a dedicated unit round-the-clock.
Stroke prevention is a major component of community education. In an effort to facilitate patient self-management, specific patient education elements should be reviewed with the patient and family regarding current treatments, discharge medications, and follow-up care. Further, information about the recognition of stroke symptoms and the actions to take are important, plus risk factor management details in order to prevent secondary stroke.
Information Management & PI
Clinical information management is vital to any program. Monitoring volumes, length of stay, discharge dispositions, various demographics, expenses, revenue, and select clinical indicators like complications can lead to a wealth of valuable information related to program operations. This data can in turn be used to establish benchmarks and/or reveal areas requiring focused improvement efforts. Market trends, clinical unit performance, and individual physician performance data should be monitored and reported within the organization to help further strengthen the program overall. Certainly, clinical information management feeds into performance measurement, which is fundamental to reviewing quality of care and developing improvement initiatives.
Certified Primary Stroke Centers must collect and report on eight quality measures for stroke as detailed in Table 2.3 Get With The Guidelines® (GWTG), a commonly used database endorsed by the American Stroke Association, includes all of the core measures that allow the institution to track adherence to the guidelines, plus provides data for benchmarking against, such as institutions.
The 2011 updated recommendations stress the importance of acute stroke teams; the importance of stroke units with telemetry monitoring; utilizing MRI with diffusion-weighted sequences, MR angiography, or CT angiography for patients who would benefit from such testing; including transthoracic echocardiography, transesophageal echocardiography, or cardiac MRI assessment; and the importance of early initiation of rehabilitation therapies.4
The “stroke” category includes patients with ischemic stroke, non-traumatic intracerebral hemorrhage, and non-traumatic subarachnoid hemorrhage. Ischemic stroke patients who fall within a three-hour window of symptom onset to treatment time may be eligible to receive thrombolytic therapy with intravenous rt-PA. There is a subgroup of patients for whom the time window can extend to 4.5 hours. Also, specific patients may be eligible for interventional therapies such as intra-arterial rt-PA or mechanical clot retrieval. The ideal “door-to-needle” time (i.e., entrance into the Emergency Department to drug initiation) for IV rt-PA is 60 minutes. This necessitates rapid identification of the type of stroke, patient assessment plus utilization of the National Institutes of Health Stroke Scale (NIHSS) and rt-PA eligibility inclusion/exclusion criteria, and the notification of appropriate personnel to institute therapy.
Because of this tight time frame, EMS cooperation is imperative. Corazon believes that the PSC should collaborate with EMS to develop/revise protocols for rapid stroke identification in the field, rapid transport, and the initiation of specific interventions such as IV starts and blood draws en route. Ongoing communication, education, and timely feedback are important to enhancing this process.
A large component of the certification process addresses stroke patients entering the hospital system through the Emergency Department (ED). However, there is a small percentage of patients who develop strokes while undergoing outpatient diagnostics or procedures or who are inpatients with non-stroke diagnoses. The stroke identification, assessment, and interventions are held to the same time frames and standards as for those patients entering via the ED. Therefore, having a protocol to contend with these patients is a necessity. This may be a matter of incorporating an acute stroke algorithm into existing algorithms for the hospital’s Rapid Response Team or may extend to educating the EP and cardiac cath lab teams regarding rapid stroke identification and emergency interventions should a stroke occur in the interventional lab setting. The same inclusion/exclusion criteria for rt-PA administration apply, as does the 60-minute “door-to-needle” time; in this case, it would be symptom recognition or “last seen normal” time to drug administration.
Once an institution feels all the certification requirements are in place, and at least four months of core measure data has been collected, they can invite The Joint Commission to review the program for certification designation. Several individual states are also now providing their own stroke center designation. The time for initial certification varies by certifying body; however, a facility must typically apply for recertification every 1–2 years.
The Healthcare Facilities Accreditation Program (HFAP), a program of the American Osteopathic Association, also offers a Primary Stroke Center Certification. The process is similar to that of The Joint Commission and also recognizes the GWTG database. There are four different levels of certification: Level 1 certification is valid for two years to stroke centers that have met the standards and have a minimum of 30 stroke patients per year; Level 2 certification is valid for one year to centers that have met the standards but have less than the minimum volume of stroke patients required; Level 3 certification is granted to facilities that generally meet the standards but need additional work to fully meet them; and Level 4 indicates that a facility has not yet met the requirements for certification.6
Comprehensive Stroke Centers
In 2005, the Brain Attack Coalition developed recommendations for a Comprehensive Stroke Center (CSC), which is defined as “a facility or system with the necessary personnel, infrastructure, expertise, and programs to diagnose and treat stroke patients who require a high intensity of medical and surgical care, specialized tests, or interventional therapies.”5 CSCs are also defined as a resource for PSCs in their regions.
A CSC is required to have a medical director trained in neurology and cerebrovascular disease, a physician with expertise and experience in neuro-rehabilitation, physicians with imaging experience in head CT or brain MRI, diagnostic radiologists, vascular surgeons, plus other personnel such as advanced practice nurses and pharmacists with stroke expertise. Dedicated neurointensive care unit beds staffed with practitioners who have expertise in providing neurocritical care is also a requirement.
The hospital must be able to provide carotid duplex ultrasound, catheter angiography 24/7, CT angiography 24/7, extracranial ultrasonography, MR angiography (MRA), MRI, including diffusion-weighted MRI 24/7, transcranial Doppler, transesophageal echocardiography, and transthoracic echocardiography.5
In addition to the hospital providing post-hospital care coordination for patients and a peer review process, and participating in stroke research activities, there will be additional performance measures (currently in development) to be collected. Unlike the PSC requirements, there will be a volume of cases requirement for the CSC set by The Joint Commission (Table 3).
Developing and sustaining a certified stroke program, whether primary or comprehensive, takes strong and focused commitment on behalf of multiple stakeholders; significant time investments for planning, development, and implementation of new care processes; substantial financial resources for facility, technology, and equipment upgrades; and dedication of staff, physicians, and hospital leadership to this daunting effort. There is no question that a decision by EP lab providers to embrace these challenges and to integrate the proven evaluation, process, and clinical care improvement strategies into the EP lab’s function can improve patient outcomes and decrease the risk of irreversible long-term complications associated with these procedures.
Indeed, primary or comprehensive stroke center certification serves as a means for an institution to evaluate and enhance its stroke care to meet, or hopefully exceed, industry standards, while raising community awareness and increasing access to lifesaving care. A certified center also serves as a beacon to EMS and the community that excellence in stroke intervention and care is important.
- Blanc JJ, Almendral J, Brignole M, et al. Consensus document on antithrombotic therapy in the setting of electrophysiological procedures. Europace 2008;10:513–527.
- Pervez MA, Silva G, Masrur S, et. al. Remote supervision of IV-tPA for acute ischemic stroke by telemedicine or telephone before transfer to a regional stroke center is feasible and safe. Stroke 2010;41:e18–e24.
- Facts about Primary Stroke Center Certification. The Joint Commission. Web. 16 Feb. 2011. Accessed 19 Mar. 2012. <www.jointcommission.org/facts_about_primary_stroke_center_certification/>
- Alberts MJ, Latchaw RE, Jagoda A, et al. Revised and updated recommendations for the establishment of primary stroke centers: A summary statement from the Brain Attack Coalition. Stroke 2011;42:2651–2665.
- Alberts MJ, Latchaw RE, Selman WR, et al. Recommendations for comprehensive stroke centers: A consensus from the Brain Attack Coalition. Stroke 2005;36:1597–1618.
- Healthcare Facilities Accreditation Program. <www.hfap.org> Accessed 30 Mar. 2012.
Jan Yanko is a Consultant at Corazon, Inc., a national leader in strategic program development for the heart, vascular, neuro, and ortho specialties, offering consulting, recruitment, interim management, and physician practice & alignment services to help clients reach their highest growth potential. To learn more, visit www.corazoninc.com, or call 412-364-8200. To reach Jan, email firstname.lastname@example.org.