Chapter 19. Designated Thrombectomy-Capable Primary Stroke Center Standards

Be designated by MIEMSS as a primary stroke center at the time of application for designation as a thrombectomy-capable primary stroke center;

Continue to meet the primary stroke center requirements in COMAR 30.08.11 to the extent such requirements are consistent with designation as a thrombectomy-capable primary stroke center;

Require each physician who performs mechanical thrombectomy to have performed 15 mechanical thrombectomies over the past 12 months or 30 over the past 24 months, which may include procedures performed at other facilities;

Perform mechanical thrombectomy and have provided post-procedure care for a minimum of 15 patients in the past 12 months or at least 30 patients over the past 24 months;

Meet the requirements of Regulations .01—.15 of this chapter;

Satisfy the MIEMSS requirements for designation as a thrombectomy-capable primary stroke center by MIEMSS; and

Meet the requirements for a site review in COMAR 30.08.02.06, which may be satisfied by completing either:

In addition to meeting the requirements of COMAR 30.08.11.05, the acute stroke team shall include at a minimum:

If a physician otherwise satisfies §A(1) of this regulation but is not Board-certified or Board-eligible in neurology, a Board-certified or Board-eligible neurologist shall be available within 15 minutes for consultation under the terms of a written agreement by:

Has designated beds for the care of the acute stroke patient;

Has 24/7 on-site practitioners with critical care privileges, including, for example, APNs, PAs, fellows, or residents;

Provides care to acute stroke patients through qualified clinical staff who meet the requirements in Regulation .11 of this chapter;

Follows standardized processes derived from evidence-based clinical practice guidelines to facilitate clinical care;

Incorporates individualized plans of care that are based on the patient’s assessed needs and reflect coordination of care with other programs, as determined by patient comorbidities;

Has a process to assess the abilities and resources of family members to be involved in post-acute care; and

Maintains written documentation delineating the function of the intensive care unit, including:

Carotid duplex ultrasound;

Transcranial ultrasonography; and

Transesophageal/transthoracic echocardiogram.

Interventional services promptly available 24 hours a day with appropriately trained support staff and necessary equipment;

Interventional services that include:

A neurointerventionalist who may be a Board-certified/Board-eligible neuroradiologist, neurologist, or neurosurgeon on-call with a 45-minute arrival time to the hospital;

An on-call schedule for a primary and a back-up neurointerventionalist; and

A written protocol to accept the inter-facility transfer of acute ischemic stroke patients requiring endovascular therapy that includes communication and feedback to the sending facility.

4 or more hours of category 1 or 2 CME credits per year related to stroke care; and

Performed 15 mechanical thrombectomies over the past 12 months or 30 over the past 24 months.

Have written policies ensuring that:

Have written procedures demonstrating the ability to care for two complex interventional radiology stroke patients at one time, using appropriate clinical staff;

Have written documentation demonstrating on-call and back-up on-call schedules for physicians and staff for 24/7 coverage;

Have written care protocols for advanced treatment of complex stroke patients, including, but not limited to, acute ischemic stroke patients and acute intra-arterial therapeutic interventions; and

Document and review the scope of practice and the roles and responsibilities of nurse practitioners and physician assistants providing care to the acute stroke patient in the intensive care unit, the emergency department, and the stroke unit.

Monitor and demonstrate 24-hour post-procedure stroke and death rates of less than or equal to 1 percent for diagnostic neuro-angiography;

Monitor documentation of the reasons potentially eligible ischemic stroke patients did not receive mechanical thrombectomy;

Monitor and demonstrate tracking and trending of modified Rankin Scores (mRS) at 90 days post-discharge on patients with acute ischemic stroke who received mechanical endovascular reperfusion therapy;

In cases where mechanical endovascular reperfusion therapy is appropriate, achieve door-to-device times, arrival to first pass of thrombectomy device, in 50 percent or more of eligible acute ischemic stroke patients within 120 minutes for direct arriving patients and within 60 minutes for inter-facility transfer patients treated with endovascular therapy; and

Demonstrate progress towards reducing door-to-device times, arrival to first pass of thrombectomy device in 50 percent or more of eligible acute ischemic stroke patients within 90 minutes for direct arriving patients.