In addition to meeting the requirements of COMAR 30.08.11.01, a designated comprehensive stroke center hospital shall: Be designated by MIEMSS as a primary stroke center at the time of application for designation as a comprehensive 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 comprehensive stroke center; Act as a resource center for other facilities in its region or state; Annually care for at least 20 Subarachnoid Hemorrhage by aneurysm patients per year; Annually perform a combined total of 15 endovascular coiling and surgical clippings per year for aneurysm; Annually administer fibrinolytics to 25 eligible patients per year or 50 eligible patients over 2 years: IV fibrinolytic ordered and monitored via telemedicine at another hospital is acceptable; and IV fibrinolytic administered at an outside hospital and transferred to CSC site is acceptable; Satisfy the MIEMSS requirements for designation as a comprehensive 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: 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 comprehensive stroke center if the hospital: Authorized 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 a comprehensive stroke center; 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 designated comprehensive stroke center shall meet the requirements of COMAR 30.08.11.02. The designated comprehensive stroke center shall meet the requirements of COMAR 30.08.11.03. The designated comprehensive stroke center shall maintain a dedicated neuroscience intensive care unit that meets the requirements of this regulation and: Has designated beds for the care of acute stroke patients; Has 24/7 on-site practitioners with neurovascular training, including, for example, APNs, PAs, neuro-intensivists, fellows, or residents; Provides care to acute stroke patients through qualified clinical staff who meet the requirements in Regulations .12—.15 of this chapter; Follows standardized processes derived from evidence-based practice 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 neuroscience intensive care unit, including: Admission criteria; Discharge criteria; Acute stroke care protocols; Interdisciplinary rounding; Rehabilitation assessment and services in the hospital; and Outcome data. In addition to meeting the requirements of COMAR 30.08.11.07, the designated comprehensive stroke center shall: Have sufficient personnel available to respond to health care personnel at other hospitals to provide them with guidance and recommendations about the diagnosis and treatment of stroke and referral to an appropriate facility if transfer is required or requested; Have written policies or procedures to direct the organized, safe, intra-hospital and inter-hospital transport of stroke patients; Have priority bed availability for stroke patients with appropriately trained registered nurses in sufficient numbers based on patient acuity; and Have a written plan for triaging patients from the neuroscience intensive care unit and/or the dedicated this unit to make beds available for other stroke patients when necessary or for provision of alternate critical care beds for stroke patients with appropriately trained registered nurse staff. In addition to meeting the requirement of COMAR 30.08.11.05, 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; Use the National Institutes of Health Stroke Scale (NIHSS) for the initial assessment of patients with acute stroke, with clinicians performing an NIHSS having documented training in the completion of the NIHSS; and Perform ongoing neurological assessment on patients with acute stroke. 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; or Emergency 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 neurology resident or fellow; An internist; A registered nurse; A physician assistant; or A nurse practitioner. If a physician otherwise satisfies §B(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: Telephone; or Audio/visual communication. In addition to meeting the requirements of COMAR 30.08.11.04, the hospital shall have: An attending board certified/board eligible neurosurgeon on call with a 45-minute arrival time to the hospital; Written procedures demonstrating the ability to care for two complex neurosurgical stroke patients at one time using appropriate clinical staff; and Written documentation demonstrating on-call and back-up on-call schedules for physicians and staff for 24/7 coverage. The hospital shall have: Interventional services promptly available 24 hours a day with appropriately trained support staff and equipment, including: Intra-arterial reperfusion therapy; Endovascular treatment of vasospasm; Endovascular ablation of arterial venous malformations; Stenting/angioplasty of extracranial vessels; and Stenting/angioplasty of intracranial vessels; 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 primary and back-up neurointerventionalists or neuroradiologists; 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; and A written protocol to accept the inter-facility transfer of acute stroke patients requiring a higher level of care. In addition to meeting the requirements of COMAR 30.08.11.09, a designated comprehensive stroke center shall have the following diagnostic capability available when indicated: Carotid duplex ultrasound; Transcranial ultrasonography; and Transesophageal or transthorasic echocardiogram. The hospital shall meet the requirements of COMAR 30.08.11.08. Director. The stroke center medical director shall be a physician with competence in caring for the acute stroke patient and be Board-certified or Board-eligible in: Neurology; Neurosurgery; or Vascular neurology. The stroke center medical director’s qualifications shall include: Completion of a stroke fellowship or vascular neurosurgery fellowship and obtained vascular neurology certification by the American Board of Psychiatry and Neurology; Active participation in the Stroke Quality Improvement Council (QIC); 12 hours of category 1 CME credits related to stroke care annually; Participation in at least one regional, national, or international stroke conference annually; Participation in stroke patient morbidity and mortality reviews; and Participation in stroke research and publication efforts. Neurologists, Neurosurgeons, NeurInterventionalists, NeuroRadiologisst, NeuroIntensivists, and Vascular Surgeons. Qualifications for neurologists, neurosurgeons, neurointerventionalists, neuroradiologists, vascular surgeons and neurointensivists shall include: Board certification or Board eligibility in their specialty as approved by the American Board of Medical Specialties; Completion of: A fellowship; Demonstrated experience equivalent to completion of a stroke specialty fellowship appropriate to their area of expertise; or Both of these; 8 or more hours of category 1 or 2 CME credits per year related to stroke care; Participation in stroke patient morbidity and mortality reviews; and Participation in stroke research and publication efforts. Emergency Physicians. The qualifications of emergency physicians who care for stroke patients shall include: Board certification or Board eligibility in emergency medicine as approved by the American Board of Medical Specialties; Participation in stroke patient morbidity and mortality reviews; 4 or more hours of category 1 or 2 CME credits per year related to stroke care; and Participation in stroke research and publication efforts. Nurse Practitioners. Nurse Practitioners who care for stroke patients shall: Hold a current license with the Maryland State Board of Nursing to practice as a registered nurse; Maintain certification as a nurse practitioner from the American Nurses Credentialing Center or other certification organization as deemed appropriate by the Maryland State Board of Nursing; and Be credentialed through the hospital’s credentialing process. Physician Assistants. Physician assistants who care for stroke patients shall: Have graduated from a physician assistant educational program accredited by the Accreditation Review Commission on Education for the Physician Assistant or its successor; Maintain current certification by the National Commission on Certification of Physician Assistants; Maintain an approved delegation agreement on file with the Maryland Board of Physicians; and Be credentialed through the hospital credentialing process. Clinical nurses, nurse practitioners, and physician assistants providing care to stroke patients in the neuroscience intensive care unit shall be trained in assessment of neurological function and management and treatment of all aspects of neurocritical care, including: Function of ventriculostomy and external ventricular drainage apparatus; Monitoring and treatment of increased intracranial pressure; Care of patients with intracranial hemorrhage and subarachnoid hemorrhage; Care of patients post fibrinolytic therapy; Care of patients post mechanical thrombectomy; Treatment of blood pressure abnormalities with parenteral vasoactive agents; Management of intubated/ventilated patients; and Detailed neurological assessments and scales (i.e., National Institute of Health Stroke Scale and the Glasgow Coma Scale). Continuing education requirements for nurses, nurse practitioners, and physician assistants who care for the acute stroke patients in the neuroscience intensive care unit shall include at least 5 hours of stroke-specific education annually. Emergency department nurses, nurse practitioners, and physician assistants who triage patients in the emergency department or care for acute stroke patients shall be trained in: Assessment of acute stroke; Treatment of acute stroke; Use of clinically appropriate fibrinolytic in acute ischemic stroke and the indication for endovascular therapy in acute ischemic stroke; Mechanical thrombectomy protocols; Treatment of blood pressure abnormalities with parenteral vasoactive agents; Neurological assessments and scales (i.e., National Institute of Health Stroke Scale and the Glasgow Coma Scale); Management of intubated/ventilated patients; and Care of patients post fibrinolytic therapy. Continuing education requirements for nurses, nurse practitioners, and physician assistants who care for the acute stroke patients in the emergency department shall include at least 5 hours of stroke-specific education annually. Continuing education requirements for nurses, nurse practitioners and physician assistants who care for the acute stroke patients in the stroke unit shall include a minimum of 5 hours of stroke-specific education annually. The designated comprehensive stroke center shall meet the requirements of COMAR 30.08.11.12. In addition to meeting the requirements of COMAR 30.08.11.13, the hospital shall: Have written policies ensuring that: Transfer of patients from another facility is appropriate and patients are received in a timely manner; and All stroke patients receive care commensurate with the hospital’s designation as a comprehensive stroke center; Have written care protocols for advanced treatment of complex stroke patients, including, but not limited to, acute ischemic stroke patients, acute intra-arterial therapeutic interventions, management of intracranial hemorrhage, and management of subarachnoid hemorrhage; Have written procedures demonstrating the ability of neurosurgery and interventional radiology to care for two complex stroke patients at one time with appropriate clinicians; Maintain up-to-date written care protocols for the treatment of acute stroke in: The neuroscience intensive care unit; The stroke unit; The emergency department; and All other locations where stroke care is provided; Have established mechanisms to serve and act as a resource center for other facilities in their region or state, which shall include: Providing expertise in managing particular cases through the use of telemedicine or other alternative means; Offering guidance for triage of patients; Providing advanced diagnostic, surgical or interventional procedures and treatment to patients initially treated at a non-primary stroke center or a primary stroke center; and Acting as an educational resource for other hospitals and health care professionals; and Have written policies and or protocols delineating the scope of practice and the roles and responsibilities of nurse practitioners and physician assistants providing care to the acute stroke patient in the neuroscience intensive care unit, the emergency department, and the stroke unit. In addition to the requirements of COMAR 30.08.11.14, the hospital shall incorporate into the hospital’s quality assurance process reports about: Specific acute stroke treatment benchmarks; and Stroke treatment quality improvement goals. The hospital shall establish a multidisciplinary institutional quality assurance/performance improvement committee that meets on a regular basis to: Monitor quality benchmarks; Review complications; and Review and modify practice patterns as appropriate. In cases where mechanical endovascular reperfusion therapy is appropriate, the hospital shall 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. The hospital shall demonstrate progress towards reducing door-to-device times in 50 percent or more of eligible acute ischemic stroke patients within 90 minutes for direct arriving patients. A hospital shall: Have an acute stroke research program and acute stroke research plan; and Demonstrate participation in clinical research trials in acute stroke care. Education Article, §13-509, Annotated Code of Maryland Effective date: October 17, 2011 (38:21 Md. R. 1280) Chapter revised effective January 1, 2022 (48:22 Md. R. 938)