These "Frequently Asked Questions" and "Guidelines" are provided to assist hospitals in the development of hospital protocols and in the evaluation of their Primary Stroke Service. The Guidelines are based on Primary Stroke Service regulations 105 CMR 130.1400 -130.1413 (see Hospital Licensure Regulations (RTF) rtf format of 105cmr130.rtf
file size 1MB ), standards of practice and/or consultation with members of the Massachusetts Department of Public Health Hospital Stroke Care Advisory Committee.

What are the guidelines for PSS protocol development?

As required under 105 CMR 130.1405, the hospital must develop and implement written care protocols for acute stroke ( ischemic and hemorrhagic) that are based on previously published guidelines and/or developed by a multidisciplinary team organized by the Stroke Service. The protocols must be available in the Emergency Department (ED) and other areas likely to evaluate and treat patients with acute stroke, and be reviewed and revised as necessary and at least annually (see also 105 CMR 130.1413). 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:

  • 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 130.1405(B)(2))
  • Identification of Acute Stroke Team, e.g., members, qualifications, availability and responsibilities, system to promptly notify and activate the Acute Stroke Team (see 130.1401;130.1405(B)(3))
  • Identification of acute stroke triage plan, e.g., patient assessment, recent medical history, pre-incident history, medication history (see 130.1405(B)(1))
  • Initial and ongoing patient clinical assessments (e.g., history, general exam, neurological exam, use of formal stroke scale or scoring system, such as the National Institute of Health Stroke Scale (NIHSS), and documentation that describes the patient's progress and response to medication and services (see 42 CFR 482.24(c))
  • Stabilization of vital functions, ongoing monitoring, management of increased intracranial pressure and blood pressure (see 130.1405(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, chest x-rays, as necessary (see 130.1405(A), and 130.1406 - 130.1408)
  • Use of medications, including but not limited to intravenous tissue-type plasminogen activator (IV t-PA), patient eligibility criteria for IV-tPA, including contraindications/warnings, management of complications and post-thrombolysis management plan (see 130.1405(A)(B))
  • Time target goals for assessment, management and intervention. See PSS Time Target Recommendations (PDF) pdf format of pss-time-target-recommendations.pdf
rtf format of pss-time-target-recommendations.rtf on the MDPH website
  • Telemedicine/Teleradiology Services, if applicable, including notification system, staff responsibilities and availability; staff qualifications and appointment/re-appointment and scope of privileges; written service agreement; quality assurance evaluations
  • Post-admission care (see 130.1405(A))
  • Patient/Family Education, e.g., potential complications, diagnostic testing, risk/benefits of treatment
  • Hospital follow-up process, for patients who received IV-tPA and were subsequently transferred to a second hospital, to determine if the patient had a hemorrhagic complication within 36 hours of receiving IV-tPA.

What is the role of the Stroke Committee and how does it differ from the Acute Stroke Team?

The Stroke Committee, as defined in 105 CMR 130.1413, is a committee designated by the governing body of the hospital that includes the physician who serves as Stroke Service Director or Coordinator (see 105 CMR 130.1404). The Committee is responsible for the review of the stroke protocols at least annually (and revision as necessary), including a review of the number and types of stroke patients, nature of any complications of thrombolytic therapy, and compliance with PSS regulations 105 CMR 130.1400 through 130.1413, including adherence to time targets.

The Acute Stroke Team, as defined in 105 CMR 130.1401, means physician(s) and other health care professionals, e.g., nurse, physician's assistant, or nurse practitioner, with stroke expertise who are available to respond and evaluate patients presenting with acute stroke symptoms (the composition of the response "team" is further defined by each hospital).

What is the expectation regarding hospital follow-up (on patients who received IV-tPA and were subsequently transferred to a second hospital) to determine if the patient had a hemorrhagic complication within 36 hours of receiving 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).

What are the qualifications for the physician designated as Stroke Service Director or Coordinator?

As required under 105 CMR 130.1404, the hospital shall designate a licensed physician with acute stroke expertise (see 105 CMR 130.1401) , 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 of the following: (1) completion of a stroke fellowship, (2) participation (as an attendee or faculty) in at least two regional, national, or international stroke courses or conferences each year, (3) five or more peer-reviewed publications on stroke, (4) eight or more continuing medical education (CME) credits each year in the area of cerebrovascular disease, or (5) other criteria approved by the governing body of the hospital.

Will a generic transfer agreement be acceptable or is a stroke specific agreement required?

As required under 105 CMR 130.1409(B), if protocols includes the transfer of patients to another hospital, the hospital shall maintain a transfer agreement that describes the responsibilities of each hospital and is signed by the Stroke Service Director, the Medical Director of each hospital or his/her designee, and the Chief Executive Officer of each hospital or his/her designee.

Demonstration of compliance with stroke specific requirements in a generic transfer agreement would include a reference to adherence to all applicable federal, state and local laws and regulations, including 105 CMR 130.1400 through 130.1413, by the transferring and receiving hospitals. An addendum or protocol, signed by staff from both the sending and receiving hospitals (as specified above), may be used as an alternative to supplement a generic agreement.

What are the guidelines for continuing education for health care professionals?

As required under 105 CMR 130.1411, the hospital shall provide hospital-based staff education that addresses the needs of physicians, nurses, allied health professionals, and Emergency Medical Services (EMS) personnel. The program shall include ongoing formal training of ED and EMS system personnel in acute stroke prevention, diagnosis and treatment. Educational programs should be developed and provided in accordance with staff needs. The Department expects that a minimum of one hour of formal stroke education should 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 130.1411):

  • ED physicians, ED nurses, other ED allied health providers, and EMS personnel are required to have ongoing, formal education. It is recommended that training for personnel in other hospital departments is included, as applicable.

Required content for ongoing educational programs for health care professionals (see 130.1411) includes:

  • Acute stroke prevention, diagnosis, and treatment

The Department would find any of the following methods to be acceptable to demonstrate compliance with the regulation, provided the required educational content is included:

Optional methods for health care professional education

  • 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, content outline, and certificate of completion)
  • Webinars
  • Morbidity and Mortality Meetings (only if devoted to stroke case review)
  • Certification/recertification education and training for Advanced Cardiac Life Support (ACLS) and the National Institute of Health Stroke Scale (NIHSS)
  • An on-line (e-learning module) equal to one hour of tutorial and post-testing related to stroke prevention, diagnosis and treatment

Demonstration of compliance

  • Attendance sheets
  • Topic and content outline including subjects listed in the PSS regulations
  • If not a live presentation:
    • A post-test is given
    • Results of the post-tests are maintained
    • Post-tests are used as part of an educational needs assessment
    • Post-tests are trended and used to improve the presentation
    • A system is in place for participants to ask questions
    • A system is in place to answer participants' questions

What are the guidelines for community education?

As required under 105 CMR 130.1412, the hospital 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 should be developed and provided in accordance with the needs of each hospital's community.

Required content for community education programs (see 130.1412) includes:

  • Stroke prevention
  • Recognition of stroke symptoms, and/or
  • Treatment of stroke

The Department would find any of the following methods to be acceptable to demonstrate compliance with the regulation, provided the required educational content is included:

Optional methods for community education

  • 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

Demonstration of compliance

  • Log of the number of brochures used, ordered and/or mailed
  • Attendance sheets for live presentations
  • Copies of flyers/announcements/publicity for public events
  • Documentation of dates, persons involved, summary of media events (e.g., television, radio)

Suggestions and recommendations

  • Coordinate community education initiatives with other hospital personnel, e.g., public relations department, diabetic educators, cardiac rehabilitation services
  • Encourage stroke survivors to share their experiences at speaker forums

Issues for hospitals to consider in the assessment of their Hospital Stroke Program and opportunities for improvement:

  • 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 physicians 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 PSS recommended time targets to evaluate and identify reasons for delays 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 compared to the hospital's documentation of the patient's arrival time at triage? Is there a significant discrepancy in these times (e.g., greater than 15 minutes). 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)?
  • 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?
  • If the hospital has expanded the IV-tPA administration time to 4.5 hours, have hospital protocols been revised to reflect the change? Is a 60-minute "door to needle" time for administration of IV-tPA still maintained as the goal?