# COMAR Title 30 — Maryland Institute for Emergency Medical Services Systems (MIEMSS)

## Subtitle 08 — Designation of Trauma and Specialty Referral Centers

### Chapter 18 — Designated Acute Stroke Ready Center

**Authority:** Education Article, §13-509, Annotated Code of Maryland

**Administrative History:** Effective date: July 1, 2021 (48:9 Md. R. 360)

**Administrative History:** Regulation effective July 21, 2025 (52:14 Md. R. 714)

#### Regulation .01 Designated Acute Stroke Ready Center.

*COMAR 30.08.18.01*

A designated acute stroke ready center shall:

A. Be licensed as a hospital or freestanding medical center by the licensing authority in the jurisdiction in which it is located;

B. If a hospital, be 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;

C. If located in Maryland, be a base station approved under COMAR 30.03.06;

D. 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;

E. Have a stroke center medical director;

F. Have a stroke center nurse coordinator dedicated to the facility;

G. Have sufficient personnel and resources needed to facilitate healthcare data management and concurrent review of quality metrics and program objectives;

H. Meet the requirements of Regulations .02—.14 of this chapter;

I. Satisfy the MIEMSS requirements for designation as an Acute Stroke Ready Center; and

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

  (1) An on-site review by MIEMSS; or

  (2) A site survey as part of The Joint Commission Disease Specific Care Certification Program for certification as an acute stroke ready center if the facility:

    (a) Authorizes The Joint Commission to provide MIEMSS with survey findings, certification reports, and other information related to The Joint Commission’s certification of the hospital as an acute stroke ready center;

    (b) Allows MIEMSS to participate in the accreditation site survey; and

    (c) Provides MIEMSS any additional information required to determine it has satisfied the requirements for designation under this chapter.

#### Regulation .02 Organization.

*COMAR 30.08.18.02*

The facility’s board of directors, administrators, and medical and nursing staff shall demonstrate commitment to the facility’s designation as an acute stroke ready center by:

A. A board of directors’ resolution stating that the facility agrees to meet the standards of this chapter for designation as an acute stroke ready center;

B. An organizational chart showing key stroke center personnel, including the stroke center medical director and the stroke center nurse coordinator and their relationship with the facility;

C. Establishing mechanisms to guide and assure cooperative relationships with community and professional groups committed to increasing public awareness and improving acute stroke care;

D. Maintaining documentation of stroke center leadership, including:

  (1) An appointment letter for the stroke center medical director; and

  (2) Curricula vitae of key stroke program personnel with training and expertise in cerebrovascular disease, including:

    (a) Physicians;

    (b) Stroke center nurse coordinator; and

    (c) Other key health care personnel; and

E. Maintaining bylaws, contracts, and budgets specific to acute stroke care, indicating the facility’s commitment to the financial, human, and physical resources necessary to support the facility’s designation as an acute stroke ready center.

#### Regulation .03 Emergency Department.

*COMAR 30.08.18.03*

The facility shall maintain an emergency department which:

A. Has written documentation on the process used to notify the stroke team of a patient with an acute stroke; and

B. Has sufficient emergency department clinical staff to meet the requirements of COMAR 30.08.11.05.

#### Regulation .04 Operating Room.

*COMAR 30.08.18.04*

A. The facility shall have a written agreement with a hospital which has operating room neurosurgical services available 24 hours a day with appropriately trained support staff.

B. Neurosurgical coverage shall be documented in a written plan approved by the covering neurosurgeon or neurosurgeons, stroke program leaders, and any involved facilities.

C. Neurosurgical services shall be available to patients within 2 hours of it being deemed necessary.

D. There shall be a written protocol for transfer that includes communication and feedback from the receiving facility.

#### Regulation .05 Stroke Team.

*COMAR 30.08.18.05*

A. The facility 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.

B. The facility shall have the following present at the patient’s bedside:

  (1) 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; and

  (2) At least one member of the acute stroke team to provide care and to treat an acute stroke patient within 15 minutes of notification.

C. The National Institutes of Health Stroke Scale (NIHSS) shall be used for the initial and serial assessment of patients with acute stroke. Clinicians performing the NIHSS will have documented training in the completion of the NIHSS.

D. The acute stroke team shall include at a minimum:

  (1) A physician with special competence in caring for the acute stroke patient who is Board certified or Board eligible in:

    (a) Neurology;

    (b) Emergency medicine;

    (c) Family medicine; or

    (d) Internal medicine; and

  (2) At least one additional health care clinician with experience in caring for the acute stroke patient who may be:

    (a) A family medicine physician;

    (b) An internist;

    (c) An emergency physician;

    (d) A registered nurse;

    (e) A physician assistant; or

    (f) A nurse practitioner.

E. 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:

  (1) Telephone; or

  (2) Audio/visual communication.

#### Regulation .06 Transfer of Acute Stroke Patient.

*COMAR 30.08.18.06*

The facility shall:

A. Transfer the clinically appropriate acute stroke patient after initial treatment and stabilization to the appropriate MIEMSS designated primary stroke center, primary stroke center with endovascular capability, or comprehensive stroke center; and

B. Maintain an agreement or agreements with a commercial ambulance service to:

  (1) Transfer stroke patients as clinically necessary;

  (2) Ensure the appropriate delivery of care during transport; and

  (3) Limit utilization of local emergency medical services (EMS) resources unless by pre-existing agreement.

#### Regulation .07 Stroke Unit.

*COMAR 30.08.18.07*

The facility shall:

A. If an acute care hospital, maintain a stroke unit that meets the requirements of this regulation which:

  (1) Has designated beds for the care of patients not eligible for fibrinolytic therapy or endovascular therapy through qualified clinical staff who meet the requirements in Regulation .10 of this chapter;

  (2) Develops a standardized process originating in clinical practice guidelines or evidence-based practice to deliver or facilitate the delivery of clinical care;

  (3) 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

  (4) Maintains written documentation delineating the function of the stroke unit including:

    (a) Admission criteria;

    (b) Discharge criteria;

    (c) Stroke care protocols;

    (d) Patient census;

    (e) Rehabilitation in the hospital;

    (f) Rehabilitation after discharge; and

    (g) Outcomes data; or

B. If not an acute care hospital, have a written transfer agreement with a hospital which:

  (1) Meets the requirements of this chapter;

  (2) Has an inpatient stroke unit that meets the requirements of this regulation; and

  (3) Can admit the patient after initial treatment and stabilization.

#### Regulation .08 Laboratory/Diagnostic Services.

*COMAR 30.08.18.08*

The facility 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;

B. Blood chemistries;

C. Coagulation studies;

D. Troponin;

E. Electrocardiograms; and

F. Chest radiographs.

#### Regulation .09 Neuroimaging Services.

*COMAR 30.08.18.09*

A. The facility shall have the ability 24 hours a day within 20 minutes of the patient’s arrival to complete:

  (1) All of the following:

    (a) Brain computed tomography;

    (b) CT Angiography; and

    (c) CT Perfusion; or

  (2) Magnetic resonance imaging.

B. The facility shall have the ability 24 hours a day to have computed tomographic studies interpreted within 20 minutes of their completion by a physician experienced in interpreting computed tomographic studies.

C. The facility shall have the ability 24 hours a day to have CT angiography, CT perfusion, and magnetic resonance imaging studies interpreted within 30 minutes of their completion by a physician experienced in interpreting CT angiography, CT perfusion, and magnetic resonance imaging studies.

D. The acute stroke ready center shall:

  (1) 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

  (2) Have the imaging ability to rapidly identify core (nonviable) infarct versus (potentially salvageable) penumbra.

#### Regulation .10 Qualifications of Stroke Center Director and Clinicians.

*COMAR 30.08.18.10*

A. The stroke center medical director shall be a physician with special competence in caring for the acute stroke patient who is clinically active at the facility and is Board certified or Board eligible in:

  (1) Neurology;

  (2) Internal medicine; or

  (3) Emergency medicine.

B. The stroke center medical director’s qualifications shall include active participation in the Stroke Quality Improvement Council (QIC) and 8 or more hours of category 1 CME credits related to stroke care annually.

C. Qualifications for stroke center physicians who care for stroke patients shall include 4 or more hours of category 1 or 2 CME credits per year related to stroke care.

D. Training for nonphysician stroke center professional staff who care for acute stroke patients shall include 4 or more hours of continuing medical education per year in the area of cerebrovascular disease.

#### Regulation .11 Qualifications of Emergency Department Clinical Staff.

*COMAR 30.08.18.11*

A. Emergency department clinical staff shall participate in cerebrovascular disease educational activities at least two times a year if they:

  (1) Triage patients in the emergency department; or

  (2) Care for acute stroke patients.

B. Emergency department clinical staff who triage patients in the emergency department or care for acute stroke patients shall be trained in:

  (1) Diagnosis of acute stroke;

  (2) Treatment of acute stroke; and

  (3) Use of clinically appropriate fibrinolytics and educated on the indication and referral for endovascular therapy in acute ischemic stroke.

#### Regulation .12 Prevention/Public Education.

*COMAR 30.08.18.12*

A. Surviving stroke patients and their families shall receive instruction on:

  (1) Signs and symptoms of acute stroke, including the importance of activating EMS;

  (2) Effects and prognosis of acute stroke;

  (3) Potential complications of acute stroke;

  (4) Needs and rationales for treatment;

  (5) Patient compliance instructions for risk reduction of individual risk factors and secondary prevention programs; and

  (6) Post-stroke support services.

B. The facility shall support or participate in, or both support and participate in, acute stroke educational activities developed for EMS personnel which are conducted at least once a year.

#### Regulation .13 Policies, Protocols, Guidelines, and Agreements.

*COMAR 30.08.18.13*

The facility shall develop and implement:

A. A written policy which demonstrates that the facility has established the acute stroke ready center to:

  (1) Monitor the care delivered to acute stroke patients;

  (2) Improve the quality of care delivered to acute stroke patients;

  (3) Move patients through the initial acute care phase of their hospital stay in a timely fashion; and

  (4) Ensure that all stroke patients will receive medical care commensurate with the hospital designation as an acute stroke ready center;

B. Written procedures for rapidly activating the stroke team to care for potentially eligible fibrinolytic and endovascular candidates within 15 minutes of notification;

C. Written care protocols for the treatment of acute stroke which address:

  (1) 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;

  (2) At least one member of the stroke team arriving at the acute stroke patient’s bedside within 15 minutes of notification;

  (3) Ischemic stroke;

  (4) Hemorrhagic stroke;

  (5) Stabilization of vital functions;

  (6) Initial diagnostic tests;

  (7) The use of medications including fibrinolytics;

  (8) Care of the potential endovascular candidate; and

  (9) Timely and safe patient transfer within 2 hours or less of emergency department arrival or when medically stable;

D. A current agreement with a transport service to meet the timeline in §C(9) of this regulation; and

E. A written protocol for transfer that includes communication and feedback from the receiving facility, which is:

  (1) Updated at least annually; and

  (2) Maintained up-to-date in:

    (a) The emergency department; and

    (b) All other locations where stroke care is provided.

#### Regulation .14 Quality Management.

*COMAR 30.08.18.14*

The facility shall:

A. 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;

B. Have participated in the stroke registry and maintained a stroke log for a minimum of 6 months prior to time of requesting an application;

C. Demonstrate ongoing participation in the stroke registry;

D. Authorize the stroke registry to provide the hospital data to MIEMSS for health oversight activities in a manner approved by the EMS Board;

E. Establish at least two outcome objectives that:

  (1) Are time-specific;

  (2) Are measurable;

  (3) Reflect tracking and trending of performance measures and indicators; and

  (4) Are reviewed in annual comparison studies;

F. Maintain a stroke log which includes at a minimum the following information for each entry:

  (1) The number of times the stroke team was activated;

  (2) The stroke team’s response time to the acute stroke patient;

  (3) The on-call neurologist’s response time for consultation to the acute stroke patient;

  (4) The type or types of diagnostic tests and acute treatment utilized;

  (5) The patient’s diagnosis;

  (6) Door to IV fibrinolytic time;

  (7) Patient complications;

  (8) Arrival and departure/transfer times; and

  (9) Disposition of the patient;

G. Monitor its IV fibrinolytic complications, which includes symptomatic intracerebral hemorrhage and serious life-threatening systemic bleeding;

H. 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:

  (1) Meets;

  (2) Reviews practice patterns; and

  (3) Modifies practice patterns as appropriate;

I. In cases where the administration of fibrinolytics is appropriate:

  (1) Administer the fibrinolytic within 60 minutes from the time the patient arrives at the emergency department for greater than or equal to 50 percent of eligible patients;

  (2) 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; and

  (3) Demonstrate progress towards reducing time of administration of fibrinolytics to 45 minutes for greater than or equal to 50 percent of eligible patients;

J. Incorporate into their quality assurance process progress reports about:

  (1) Specific acute stroke treatment benchmarks;

  (2) Outcomes data on patients transferred for a higher level of care; and

  (3) Stroke treatment quality improvement goals; and

K. Provide MIEMSS with documentation of quality management of the stroke program for review, including, if appropriate:

  (1) Problem identification;

  (2) Problem analysis;

  (3) An action plan;

  (4) Implementation of the plan; and

  (5) Re-evaluation of the plan.