Guidelines for Acute Stroke Ready Written Care Protocol
All hospitals with an emergency department and all satellite emergency facilities must provide acute stroke ready services (105 CMR 130.1402). Hospitals and satellite emergency facilities do not need to obtain accreditation from a nationally recognized accrediting body in order to provide acute stroke ready services. The requirements for acute stroke ready services can be found in the hospital regulation at 105 CMR 130.1402 through 130.1403.
As required under 105 CMR 130.1403, hospitals with an emergency department and satellite emergency facilities must develop and implement written care protocols for acute stroke that are based on previously published best practice guidelines and developed by a multidisciplinary team. The protocols must be available in the Emergency Department (ED) and other areas likely to evaluate and treat patients with acute stroke. The protocols must be reviewed and revised in accordance with the organization’s policy and when there are changes in best practice guidelines.
The written protocols (e.g., policies and procedures, order sets, critical pathways, algorithms) for acute stroke assessment, management and intervention, include but are not limited to:
- Identification of acute stroke triage plan, e.g., patient assessment, recent medical history, pre-incident history, medication history (see 105 CMR 130.1403(B)(1)).
- Systems for Emergency Medical Service (EMS) personnel to effectively communicate with hospital personnel during pre-hospital transport of a patient with symptoms of acute stroke, and to allow the Emergency Department (ED) to more efficiently prepare for patient arrival (see 105 CMR 130.1403(B)(2)).
- Identification of Acute Stroke Team, including team members, qualifications, availability and responsibilities, system to promptly notify and activate the Acute Stroke Team (see 105 CMR 130.1403(B)(3)).
- Identification of a specific, well-organized system for promptly notifying and activating the Acute Stroke Team to evaluate patients presenting with symptoms of acute stroke including during the pre-hospital transport by EMS (see 105 CMR 130.1403(B)(2) and (3)).
- Protocols for stabilization of vital functions, ongoing monitoring, management of increased intracranial pressure and blood pressure (see 105 CMR 130.1403(A)(B))
- Systems to promptly perform initial diagnostic tests, such as brain computed tomography (CT) or magnetic resonance imaging (MRI), laboratory (e.g., routine serum chemistry, hematology, coagulation studies), electrocardiograms, and/or chest x-rays, as necessary (see 105 CMR 130.1403(A)).
- Protocols for use of medications, including but not limited to intravenous tissue-type plasminogen activator (IV t-PA) (e.g. tenecteplase (TNK)), patient eligibility criteria for IV-tPA, including contraindications/warnings, management of complications and post-thrombolysis management plan (see 105 CMR 130.1403(A)(B)).
- Time target goals for assessment, management and intervention (see 105 CMR 130.1403(A)).
If the hospital or satellite emergency department does not have a primary stroke service or endovascular stroke service designation, the hospital or satellite emergency facility must have a coordinating stroke care agreement with a hospital with a primary stroke service or endovascular stroke service designation within their service area (see 105 CMR130.1403(C)). The coordinating stroke care agreement must be in writing and include, at a minimum, the following:
- Transfer protocols for the timely transport and acceptance of acute stroke patients for stroke treatment therapies which the facility is not capable of providing (see 105 CMR130.1403(C)(1)); and
- Communication criteria and protocols, as needed (see 105 CMR130.1403(C)(2)).
As part of the transfer protocols in a coordinating stroke care agreement, the hospital or satellite emergency facility must maintain a transfer agreement that describes the responsibilities of each hospital or satellite emergency facility and is signed by the Medical Director of each hospital or their designee, and the Chief Executive Officer of each hospital or their designee.
The coordinating stroke care agreement may include the provision of telestroke services, which is the use of interactive technology in the delivery of acute stroke care (see 105 CMR130.1403(C)).
Guidelines for Primary Stroke/Endovascular Capable Services
Hospitals demonstrating capability to care for higher-acuity stroke patients may seek certification to become a primary stroke service, primary plus stroke center, thrombectomy capable stroke center or comprehensive stroke center through a nationally recognized accreditation entity, such as the Joint Commission, Det Norske Veritas, or the Accreditation Commission for Health Care (see 105 CMR130.1404(A)).
As required under 105 CMR 130.1403(B), to be designated as an endovascular capable stroke service, a hospital must meet the criteria of a thrombectomy capable stroke center or comprehensive stroke center from a nationally recognized accrediting body and must receive certification as such from a nationally recognized accrediting body. A hospital designated as an endovascular capable stroke service must have endovascular capabilities available at all times.
Acute Stroke Team
The Acute Stroke Team, as defined in 105 CMR 130.1401, means physician(s), nurse(s), physician’s assistant(s), or nurse practitioner(s), and
other health care professionals with acute stroke expertise available for prompt consultation available 24 hours per day, consistent with time targets acceptable to the Department.
Reporting data to the Department
The hospital licensure regulations require submission of stroke data in a manner defined by the Department (see 105 CMR 130.1406(C)). All hospitals with emergency departments and satellite emergency facilities must report data on acute stroke ready services. Hospitals certified by a nationally recognized accrediting body and designated by the Department as a Primary Stroke Service or Endovascular Capable Stroke Service must also report data to the Department on stroke services provided.
The timeline for data to be submitted is two months from the last day of the month in which the patient was discharged. For example, all patients discharged in the month of May, up to May 31st, must have data entered and completed by July 31st.
Hospital follow-up on patients who received IV-tPA
Written protocols are to be jointly developed by hospitals that routinely transfer and/or receive patients. At a minimum, the protocols should identify the title(s) of the representative at the transferring hospital, and the title(s) and contact information for the representative at the receiving hospital who will provide the information on patient complications. The protocols should also include information on the timeline and process for follow-up. The contacts, manner of follow-up, and the timeframe for follow-up will vary from hospital to hospital. For example, a Stroke Coordinator at a transferring hospital contacts the Quality Assurance Manager at the receiving hospital by Fax in a timely manner (timeline to be defined in the joint hospital protocols). Subsequently, the receiving hospital provides the requested information to the transferring hospital by Fax in a timely manner (timeline to be defined in the joint hospital protocols).
Qualifications for the physician designated as Stroke Service Director or Coordinator
The hospital should designate a licensed physician with acute stroke expertise, who can represent the Primary Stroke Service and evaluate the hospital's capabilities to provide the required services, as the Stroke Service Director or Coordinator.
Acute Stroke Expertise, as defined in 105 CMR 130.1401, means any two of the following:
- Completion of a stroke fellowship,
- Participation (as an attendee or faculty) in at least two regional, national, or international stroke courses or conferences each year,
- Five or more peer-reviewed publications on stroke,
- Eight or more continuing medical education (CME) credits each year in the area of cerebrovascular disease, or
- Other criteria approved by the governing body of the hospital.
Guidelines for continuing education for health care professionals
As required under 105 CMR 130.1407, the hospital shall provide hospital-based staff education that addresses the needs of physicians, nurses, allied health professionals, and EMS personnel. The program shall include ongoing formal training of ED and EMS system personnel in acute stroke prevention, diagnosis and treatment.
The Department recommends that a minimum of one hour of formal stroke education as described below be offered to EMS personnel and provided to each ED staff member per year, however, additional education should be provided in accordance with identified staff needs. Hospitals are encouraged to partner with other hospitals or organizations in these activities.
Health care professionals required to have ongoing, formal education include (see 105 CMR 130.1407): ED physicians, ED nurses, other ED allied health providers, such as social workers, and other specialists who support the care of patients in the ED, and EMS personnel are required to have ongoing, formal education. It is recommended that training for personnel in other hospital departments be included, as applicable.
Required content for ongoing educational programs for health care professionals (see 105 CMR 130.1407) includes: Acute stroke prevention, diagnosis, and treatment
The Department will find any of the following methods to be acceptable to demonstrate compliance with the regulation, provided the required educational content is included:
- Speaker forums (e.g., lectures, Grand Round presentations)
- Videos and audio conferences (purchased)
- Videos and audio conferences (hospital presentations)
- Outside conferences (documented with program objectives and certificate of completion)
- Webinars
- Morbidity and Mortality Meetings (only if devoted to stroke case review)
- Certification/recertification education and training for the National Institute of Health Stroke Scale (NIHSS)
- On-line e-learning modules equal to one hour of tutorial and post-testing related to stroke prevention, diagnosis and treatment
- Simulation laboratory training
To demonstrate compliance with the training requirements, the hospital or satellite emergency facility must maintain:
- Attendance sheets
- Topic and content outline including subjects listed in the PSS regulations
- If not a live presentation:
- documentation a post training test is given and staff have passed;
- results of the post-tests; evidence the results of the post training tests are used as part of an educational needs assessment to plan future training opportunities;
- documentation showing that post-training tests are reviewed on an ongoing basis and used to improve the presentation;
- a system is in place for participants to ask questions; and
- a system is in place to answer participants' questions.
Guidelines for community education
As required under 105 CMR 130.1408, the hospital with a primary stroke service designation or endovascular stroke service designation shall offer community education that provides information to the public regarding prevention of stroke, recognition of stroke symptoms, and/or treatment of stroke. Community education programs must be developed and provided in accordance with the needs of each hospital's community.
Required content for community education programs (see 105 CMR 130.1408) includes:
- stroke prevention;
- recognition of stroke symptoms; and/or
- treatment of stroke.
The Department will find any of the following methods to be acceptable to demonstrate compliance with the regulation, provided the required educational content is included:
- Newsletters/Mailing
- Newspapers
- Public Service Announcements
- Stroke education/educational materials provided at locations such as community health fairs, flu/blood pressure clinics
- Education provided to area health care providers
- Speaker Forums - e.g., presentations at hospitals, community centers, senior centers, school assemblies, church groups, workplace sites
To demonstrate compliance with the community education requirements, the hospital must maintain:
- A log of the number of brochures used, ordered and/or mailed;
- attendance sheets for live presentations;
- copies of flyers/announcements/publicity for public events; and/or
- documentation of dates, persons involved, summary of media events (e.g., television, radio)
The Department recommends that hospitals consider the following in completing the required community education:
- Coordination of community education initiatives with other hospital personnel, e.g., public relations department, diabetic educators, cardiac rehabilitation services.
- Encouraging stroke survivors to share their experiences at speaker forums.
- Offering stroke education to the community in languages other than English based on the hospital’s patient population.
Issues for Hospitals to Consider in the Assessment of their Hospital Stroke Program and Opportunities for Improvement
The Department recommends that hospitals consider the following questions as they develop, maintain and seek to continually improve their stroke program:
- If a teleradiology/telemedicine service is used, are there written policies and procedures for monitoring and evaluating the effective management, safety, security and proper performance of the system? For example:
- Are written contracts provided that specify the terms of the relationship and mutual expectations?
- Are policies and procedures provided that identify how the decision to initiate a consult is determined, how the parties interact, and how the consultation care is documented?
- Is there quality monitoring of physician response times, proper performance of the system, and proper credentialing/privileging of physicians who provide the service?
- Are consults documented and forwarded to the hospital for inclusion in the referring site's patient records?
- Do licensed independent providers consistently document the reasons IV-tPA was not administered to patients at the time of the decision?
- Are patient records/registry data evaluated for accuracy of patient assessments and/or documentation of patient eligibility/ineligibility for IV-tPA? For example, are there eligible patients, without a documented contraindication and/or exclusion for administration of IV-tPA, who did not receive IV-tPA? If so, is a further review of the cases conducted?
- Is an appropriate stroke scale or scoring system, such as the National Institute of Health Stroke Scale (NIHSS), used to assess patient neurological status and to quantify the degree of neurological deficit?
- Is there a noticeable discrepancy in the documentation from various sources/providers regarding the time the patient was last known to be well? Does further documentation clarify/address any discrepancies? Is there a policy regarding which source is considered the authoritative source (e.g., the stroke neurologist) in cases of multiple times documented?
- Is the hospital using the recommended time targets to evaluate and identify opportunities for improvement in meeting the 60-minute "door to needle time" for administration of IV-tPA?
- Is EMS documentation of a patient's arrival time at the hospital consistent with the hospital's documentation of the patient's arrival time at triage? Which time is used to measure the time of arrival ("door time")?
- Are delays in administration of IV-tPA documented, such as delays in obtaining informed consent (awaiting family members' arrival)?
- Has the hospital updated its IV-tPA policies and procedures to consider tenecteplase as well as alteplase administration for patients that meet appropriate clinical criteria?
- Does the stroke program maintain a data driven quality program? Are data analyzed, documentation reviewed (e.g., refer to above noted issues), and quality improvement strategies or corrective actions implemented, as applicable? Is this QA process documented?
- How does your hospital or satellite emergency facility identify health equity in stroke care, including outcomes, treatment, and meeting recommended time targets? How does your facility ensure improvement efforts are addressed, documented, and sustained?