A designated primary stroke center hospital shall: Be licensed as an acute care hospital by the hospital licensing authority in the jurisdiction in which it is located; Be a hospital accredited by an organization that has been granted deeming authority by the Centers for Medicare & Medicaid Services and approved by the Maryland Department of Health to accredit hospitals in the State; If located in Maryland, be a base station approved under COMAR 30.03.06; Provide assessment and management of the stroke patient consistent with the most current AHA/ASA consensus based clinical practice guidelines to meet the needs of the patient; Have a stroke center medical director; Have a dedicated stroke center nurse coordinator; Have sufficient personnel and resources needed to facilitate healthcare data management and concurrent review of quality metrics and program objectives; Meet the requirements of Regulations .03—.14 of this chapter; Satisfy the MIEMSS requirements for designation as a primary stroke center; and Meet the requirements for a site review in COMAR 30.08.02.06, which may be satisfied by completing either: An on-site review by MIEMSS; or A site survey as part of The Joint Commission Disease Specific Care Certification Program for certification as a primary stroke center if the hospital: Authorizes The Joint Commission to provide MIEMSS with survey findings, certification reports, and other information related to The Joint Commission; Allows MIEMSS to participate in the accreditation site survey; and Provides MIEMSS any additional information required to determine it has satisfied the requirements for designation under this chapter. The hospital's board of directors, administrators, and medical and nursing staffs shall demonstrate commitment to the hospital's designation as a primary stroke center by: A board of directors' resolution stating that the hospital agrees to meet the standards of this chapter for designation as a primary stroke center; An organizational chart showing key stroke center personnel including the stroke center medical director and stroke center nurse coordinator and their relationship within the hospital; Establishing mechanisms to guide and assure cooperative relationships with community and professional groups committed to increasing public awareness and improving acute stroke care; Maintaining documentation of stroke center leadership including: An appointment letter for the stroke center medical director; and Curricula vitae of key stroke program personnel with training and expertise in cerebrovascular disease including: Physicians; A stroke center nurse coordinator; and Other key health care personnel; and Maintaining bylaws, contracts, and budgets specific to acute stroke care, indicating the hospital's commitment to the financial, human, and physical resources necessary to support the hospital's designation as a primary stroke center. The hospital shall maintain an emergency department which: Has written documentation on the process used to notify the stroke team of a patient with an acute stroke; and Has sufficient emergency department clinical staff to meet the requirements of Regulation .05. of this chapter. The hospital shall have: Operating room neurosurgical services available 24 hours a day with appropriately trained support staff, and: Necessary equipment and tools to aid in the care of acute stroke patients including equipment necessary for continuous hemodynamic monitoring; and A written plan for neurosurgical procedures or evaluations to be performed within 2 hours of the determination they are clinically necessary which is approved by: The neurosurgeons providing coverage; and The stroke center medical director; or A written agreement with another hospital which: Meets the requirements of this chapter; Has operating room neurosurgical facilities that meet the requirements of this regulation; and Is available to provide the required neurosurgical services to the patient. The hospital shall establish one or more acute stroke teams which shall respond to the emergency department with coordinated services for the effective delivery of emergency and acute stroke treatment. Presence at Bedside. A member of the emergency department clinical staff shall evaluate each patient with stroke-like symptoms within 10 minutes of the patient’s arrival at the emergency department. At least one member of the acute stroke team shall be present at the patient's bedside to provide care and to treat an acute stroke patient within 15 minutes of notification. The National Institutes of Health Stroke Scale (NIHSS) shall be used for the initial and serial assessment of patients with acute stroke. Clinicians performing an NIHSS will have documented training in the completion of the NIHSS. The acute stroke team shall include at a minimum: A physician with special competence in caring for the acute stroke patient who is Board certified or Board eligible in: Neurology; Critical care medicine; Emergency medicine; Family medicine; or Internal medicine; and At least one additional health care provider with experience in caring for the acute stroke patient who may be: An emergency physician; A family medicine physician; An internist; A neurology resident or fellow; A registered nurse; A physician's assistant; or A nurse practitioner. If the physician who satisfies §C(1) of this regulation 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: Telephone; or Audio/visual communication. The hospital shall: Transfer the clinically appropriate stroke patient requiring a higher level of care after initial treatment and stabilization to a MIEMSS designated primary stroke center that has endovascular capability or a MIEMSS designated comprehensive stroke center; and Maintain an agreement or agreements with a commercial ambulance service to: Transfer stroke patients as clinically necessary; Ensure the appropriate delivery of care during transport; and Limit utilization of local emergency medical services (EMS) resources unless by pre-existing agreement. The hospital shall maintain a stroke unit that meets the requirements of this regulation which: Has designated beds for the care of acute stroke patients beyond the acute treatment period; Provides care to acute stroke patients through qualified clinical staff who meet the requirements in Regulation .09 of this chapter; Develops a standardized process originating in clinical practice guidelines or evidence-based practice to deliver or facilitate the delivery of clinical care; Develops an individualized plan of care that is based on the patient’s assessed needs and reflects coordination of care with other programs as determined by patient comorbidities; and Maintains written documentation delineating the function of the stroke unit including: Admission criteria; Discharge criteria; Acute stroke care protocols; Interdisciplinary rounding; Patient census; Rehabilitation in the hospital; Rehabilitation after discharge; and Outcomes data. The hospital shall have the ability 24 hours a day to perform laboratory and diagnostic services within 45 minutes of written order including, but not limited to: A complete blood count; Blood chemistries; Coagulation studies; Troponin; Electrocardiograms; and Chest radiographs. The hospital shall have the ability 24 hours a day, within 20 minutes of the patient’s arrival, to complete: All of the following: Brain computed tomography; CT Angiography; and CT Perfusion; or Magnetic resonance imaging. The hospital shall have the ability 24 hours a day to have the neuroimages referred to in this regulation interpreted within 20 minutes of their completion by a physician experienced in interpreting computed tomographic studies. The hospital shall have the ability 24 hours a day to have the neuroimages referred to in this regulation interpreted within 30 minutes of their completion by a physician experienced in interpreting: CT angiography; CT Perfussion; and Magnetic resonance imaging studies. The hospital shall: Have the ability to upload emergent imaging scans into CRISP (Chesapeake Regional Information System for our Patients), which will facilitate sharing of emergent imaging with the receiving center; and Have the imaging ability to rapidly identify core (nonviable) infarct versus (potentially salvageable) penumbra. The stroke center medical director shall be a physician with special competence in caring for the acute stroke patient who is Board certified or Board eligible in: Neurology; Emergency medicine; Neurosurgery; Neuro interventional radiology; or Internal medicine. The stroke center medical director’s qualifications shall include: Active participation in the stroke Quality Improvement Council (QIC); and 8 hours of category 1 CME credits related to stroke care annually. Qualifications for stroke center physicians who care for acute stroke patients shall include 4 or more hours of category 1 or 2 CME credits per year related to stroke care. Training for non-physician stroke center professional staff who care for acute stroke patients shall include 4 or more hours per year of continuing education in areas related to cerebrovascular disease. Emergency department clinical staff shall participate in cerebrovascular disease educational activities at least two times a year if they: Triage patients in the emergency department; or Care for acute stroke patients. Emergency department clinical staff who triage patients in the emergency department or care for acute stroke patients shall be trained in: Diagnosis of acute stroke; Treatment of acute stroke; and Use of clinically appropriate fibrinolytics and educated on the indication and referral for endovascular therapy in acute ischemic stroke. Surviving acute stroke patients and their families shall receive instruction on: Signs and symptoms of acute stroke, including the importance of activating EMS; Effects and prognosis of acute stroke; Potential complications of acute stroke; Needs and rationales for treatment; Patient compliance instructions for risk reduction of individual risk factors and secondary prevention programs; and Post-stroke support services. The hospital shall support or participate, or both, in acute stroke educational activities developed for EMS personnel which are conducted at least once a year. The hospital shall conduct at least two times per year public education programs on: Stroke prevention; Recognition of signs and symptoms of acute stroke and the need to activate EMS; Diagnosis of acute stroke; and Treatment of acute stroke. The hospital shall develop and implement: A written policy which demonstrates that the hospital has established the stroke center to: Monitor the care delivered to acute stroke patients; Improve the quality of care delivered to acute stroke patients; Move patients through the initial acute care phase of their hospital stay in a timely fashion; and Ensure that all stroke patients will receive medical care commensurate with the hospital's designation as a primary stroke center; Written procedures for rapidly activating the stroke team to care for potentially eligible fibrinolytic and endovascular candidates within 15 minutes of notification; and Written care protocols for the treatment of acute stroke which: Address: Evaluation of each patient by a member of the emergency department clinical staff within 10 minutes of the patient's arrival at the hospital emergency department; At least one member of the stroke team arriving at the acute stroke patient's bedside within 15 minutes of notification; Ischemic stroke; Hemorrhagic stroke; Stabilization of vital functions; Initial diagnostic tests; The use of medications including fibrinolytics; Care of the potential endovascular candidate; Timely and safe patient transfer; and The hospital's plan for updating the protocols at least annually; Are maintained up-to-date in: The emergency department; The stroke unit; The intensive care unit; and All other locations where stroke care is provided. The hospital shall participate, in a manner approved by the EMS Board, in a stroke registry that includes the data elements tracked by the Centers for Medicare and Medicaid Services and the American Heart/American Stroke Get With the Guidelines® — Stroke Registry. The hospital shall authorize the stroke registry to provide the hospital's data to MIEMSS for health oversight activities in a manner approved by the EMS Board. Outcome Objectives. The hospital shall establish at least 2 outcome objectives that are: Time-specific; Measurable; Reflective of tracking and trending of performance measures and indicators; and Reviewed in annual comparison studies. The hospital shall monitor IV fibrinolytic complications, which include symptomatic intracerebral hemorrhage and serious life-threatening systemic bleeding. The hospital shall monitor and demonstrate tracking and trending of modified Rankin Scores (mRS) at discharge and at 90 days post-discharge on patients with acute ischemic stroke. The hospital shall establish at least one stroke center quality assurance medical review committee which shall be a medical review committee under Health Occupations Article, §1-401, Annotated Code of Maryland, as a committee established in the Maryland Institute for Emergency Medical Services Systems which, at least three times a year: Meets; Reviews practice patterns; and Modifies practice patterns as appropriate. In cases where the administration of fibrinolytics is appropriate, the hospital shall administer fibrinolytics within 60 minutes from the time the patient arrives at the emergency department for greater than or equal to 50 percent of eligible patients. The hospital shall demonstrate progress towards administering fibrinolytics within 60 minutes from the time the patient arrives at the emergency department for greater than or equal to 75 percent of eligible patients. The hospital shall demonstrate progress towards reducing time of administration of fibrinolytics to 45 minutes for greater than or equal to 50 percent of eligible patients. The hospital shall incorporate into the hospital’s quality assurance process progress reports about: Specific acute stroke treatment benchmarks; Outcomes data on patients transferred for higher level of care; and Stroke treatment quality improvement goals. The hospital shall provide MIEMSS with documentation of quality management of the stroke program for review including, if appropriate: Problem identification; Problem analysis; An action plan; Implementation of the plan; and Reevaluation of the plan. Education Article, §13-509, Annotated Code of Maryland Effective date: June 5, 2006 (33:11 Md. R. 952) Regulation .06B amended effective June 4, 2007 (34:11 Md. R. 973) Chapter revised effective July 1, 2021 (48:9 Md. R. 360) Regulation .01B amended effective July 21, 2025 (52:14 Md. R. 714) Regulation .15 repealed effective October 18, 2021 (48:21 Md. R. 892)