DEPARTMENT OF HEALTH AND HUMAN SERVICES  
BUREAU OF EMERGENCY PREPAREDNESS, EMS, AND SYSTEMS OF CARE  
EMS AND SYSTEMS OF CARE SECTION  
STATEWIDE STROKE SYSTEM  
Filed with the secretary of state on November 6, 2023  
These rules become effective immediately after filing with the secretary of state unless adopted  
under section 33, 44, or 45a(9) of the administrative procedures act of 1969, 1969 PA 306, MCL  
24.233, 24.244, or 24.245a. Rules adopted under these sections become effective 7 days after  
filing with the secretary of state.  
(By authority conferred on the director of the department of health and human services by  
sections 2233, 9227, and 20910 of the public health code, 1978 PA 368, MCL 333.2233,  
333.9227 and 333.20910, and section 1186 of article 6 of 2022 PA 166)  
R 330.251, R 330.252, R 330.253, R 330.254, R 330.255, R 330.256, R 330.257, R 330.258, R  
330.259, R 330.260, R 330.261, R 330.262, and R 330.263 are added to the Michigan  
Administrative Code, as follows:  
PART 1. GENERAL PROVISIONS  
R 330.251 Definitions; A to D.  
Rule 1. As used in this part:  
(a) “Administrative hearing” means a hearing conducted pursuant to the administrative  
procedures act of 1969, 1969 PA 306, MCL 24.201 to 24.328.  
(b) “CMS” or “Centers for Medicare and Medicaid Services” means the program that is part of  
the United States Department of Health and Human Services.  
(c) “Certification” means a process that a healthcare facility undergoes to demonstrate it has  
met predetermined standards of a department-approved, CMS-recognized professional certifying  
organization.  
(d) “Code” means the public health code, 1978 PA 368, MCL 333.1101 to333.25211.  
(e) “Department” means the department of health and human services.  
(f) “Designation” means a status that is conferred by the department on stroke centers that are  
verified by a CMS-recognized professional certifying organization.  
(g) “Disciplinary action” means an action taken by the department against a healthcare facility  
or a regional stroke network for failure to comply with the code, rules, or protocols approved by  
the department.  
R 330.252 Definitions; E to O.  
Rule 2. As used in this part:  
(a) “EMS” means emergency medical services.  
(b) “Healthcare facility” means a facility licensed under section 20141 or 21511 of the code,  
MCL 333.20141 and 333.21511, which operates a service for treating emergency patients, 24  
hours per day, 7 days per week.  
September 14, 2023  
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(c) “Hold itself out” means the agency, healthcare facility, or stroke care facility that advertises,  
announces, or charges specifically for providing stroke care.  
(d) “Inter-facility transfer of stroke patient” means identifying the group of stroke patients that  
require additional stroke resources with the goal of providing optimal care to these patients by  
the timely transfer to an appropriate level of care to optimize the outcome.  
(e) “MCA” or “medical control authority” means an organization designated by the department  
to provide medical control.  
(f) “MCA area” means the geographic area comprised of a county, group of counties, or parts of  
an individual county as designated by the department.  
(g) “Medical control” means the supervision and coordination of EMS through a MCA, as  
prescribed, adopted, and enforced through department-approved protocols, within an emergency  
medical system.  
(h) “Non-designated healthcare facility” means a healthcare facility that has chosen not to be a  
part of this state's stroke system of care or a healthcare facility that the department has not  
designated as a stroke center.  
R 330.253 Definitions; P to V.  
Rule 3. (1) As used in this part:  
(a) “Protocol” means a patient care standard, standing order, policy, or procedure for providing  
EMS that is established by an MCA and approved by the department under section 20919 of the  
code, MCL 333.20919.  
(b) “Provisional” means a one-time, temporary-time-limited status conferred on a facility by the  
department that most closely matches the current level of care based on the published criteria for  
certification for which it is applying.  
(c)”PSRO” or “"professional standards review organization” means a committee established by  
a life support agency or MCA for the purpose of improving the quality of medical care, as  
provided in section 1 of 1967 PA, 270, MCL 331.531.  
(d) “Quality improvement program” means actions taken by a life support agency, MCA, stroke  
center, or jointly between a life support agency, MCA, or stroke center with a goal of continuous  
improvement of medical care in accordance with the code. Actions must take place under a  
PRSO, as provided in sections 1 to 3 of 1967 PA 270, MCL 331.531 to 331.533.  
(e) “RPSRO” or "regional PRSO” means a committee established by the regional stroke system  
for the purpose of improving the quality of stroke care within a recognized stroke region as  
provided in sections 1 to 3 of 1967 PA 270, MCL 331.531 to 331.533.  
(f) “Regional stroke plan” means a written plan prepared by a regional stroke advisory council,  
and approved by the regional stroke system, that is based on minimum criteria established by the  
department.  
(g) “RSAC” or “regional stroke advisory council” means a committee established by a regional  
stroke system whose function is to provide leadership and direction in matters related to stroke  
system development in their region, and to monitor the performance of the stroke agencies and  
healthcare facilities within the region, including, but not limited to, the review of stroke deaths  
and preventable complications, and it is comprised of the following:  
(i) MCA personnel.  
(ii) EMS personnel.  
(iii) Life support agency representatives.  
(iv) Healthcare facility representatives.  
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(v) Physicians.  
(vi) Nurses.  
(vii) Consumers.  
(h) “Regional stroke system” means an organized group comprised of the local MCA within a  
region, that integrates into existing regional trauma network or regional systems of care authority  
and is responsible for appointing a regional stroke advisory council and creating a regional stroke  
plan.  
(i) “Regional systems of care authority” means an organization recognized by the department,  
comprised of approved MCAs within a region, also approved as the Regional Trauma Network,  
which provides clinical oversight for the regional trauma system, regional stroke system and  
regional STEMI system within the region.  
(j) “Statewide stroke care advisory subcommittee” means a stroke care advisory subcommittee  
that acts as the department’s subject matter experts for the clinical and operational components  
of stroke care. As the system matures and signals readiness to capitalize on efficiencies, the  
system will merge into the statewide stroke care advisory subcommittee and the statewide  
STEMI care advisory subcommittee into the statewide cardiovascular care advisory  
subcommittee.  
(k) “Statewide stroke registry” means a system for collecting data that the department manages,  
analyzes, and disseminates results.  
(l) “Statewide stroke system of care” means a comprehensive and integrated arrangement of  
emergency services personnel, stroke centers, equipment, services, communications, MCAs, and  
organizations necessary to provide stroke care to all patients within a particular geographic  
region.  
(m) “STEMI” means an ST-segment elevation myocardial infarction defined by symptoms of  
myocardial infarction associated with an ST-segment elevation on an ECG.  
(n) “Stroke” means a cerebrovascular disease that causes a sudden interference in the blood  
supply to the brain causing neuronal injury with neurological symptoms. This occurs when a  
blood vessel in the brain is blocked by a clot or a vessel rupture.  
(o) “Stroke bypass” means to forego EMS transport of a patient to the nearest healthcare facility  
for facility whose resources are more appropriate to the stroke patient, pursuant to direction  
given to pre-hospital EMS by online medical direction or predetermined triage criteria, as  
established by department-approved protocols.  
(p) “Stroke care” means diagnostic evaluation, triage, acute intervention, emergency transport  
and other acute care services for stroke patients who potentially require emergent medical or  
surgical intervention or treatment, and may include education, risk reduction, and subacute  
stroke management.  
(q) “Stroke center” means a healthcare facility designated by the department as having met the  
criteria set forth by a department-approved, CMS-recognized professional certifying organization  
as being any of the following:  
(i) Level I or comprehensive stroke center.  
(ii) Level II or thrombectomy capable stroke center.  
(iii) Level III or primary stroke center.  
(iv) Level IV or acute stroke ready center.  
(r) “Stroke diversion” means the re-routing of a stroke patient from a stroke care facility that  
has 1 or more of its essential resources currently functioning at maximum capacity, or is  
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otherwise unavailable, to an alternate stroke care facility to serve the best interests of the stroke  
patient.  
(s) “Stroke response” means an individual who has been identified as a potential stroke patient  
and requires the utilization of the stroke care system.  
(t) “Triage” means classifying patients according to the severity of their medical conditions.  
(u) “Verification” means an evaluation process conducted by a national professional certifying  
organization to verify resources and improve stroke care.  
(2) A term defined in the code has the same meaning when used in these rules.  
R 330.254 Powers and duties of department.  
Rule 4. (1) The department, with the advice of the state EMS coordination committee and  
statewide stroke care advisory subcommittee, shall do all the following:  
(a) Implement an all-inclusive stroke system throughout this state that allows for the care of all  
stroke patients in an integrated system of healthcare in the pre-hospital and healthcare facility  
environments by personnel that are well trained and equipped to care for stroke patients.  
(b) Perform all of following:  
(i) Establish regional systems of care authorities comprised of the MCAs in each region  
currently approved as regional trauma networks. The regional systems of care authority shall  
provide oversight for the regional trauma system, regional stroke system and regional STEMI  
system within the region.  
(ii) Establish a statewide stroke care quality improvement program using a statewide database.  
(iii) Monitor the statewide stroke system.  
(iv) Ensure the coordination and performance of the regional stroke systems.  
(v) Set minimum standards for system performance and stroke patient care.  
(c) Develop a statewide process to establish regional stroke systems comprised of the local  
MCAs within a region in a manner that integrates the stroke system into existing regional  
trauma, EMS, and medical control systems.  
(d) Develop, implement, and maintain a state stroke systems of care plan.  
(e) Develop a statewide process for the verification of stroke resources based on a stroke  
center’s current certification by a department-approved, CMS-recognized professional certifying  
organization.  
(f) Develop a statewide process for the designation of stroke centers.  
(g) Develop an appeals process for healthcare facilities to contest their designation  
determination.  
(h) Establish state stroke care recommendations and approve regional stroke protocols that are  
established and adopted by the local MCA.  
(i) Recognize the regional stroke systems providing system oversight of the stroke care  
provided in each region of this state.  
(j) Regional stroke systems must be integrated into the established regional systems of care  
authority composed of the collaborating local MCAs in a region.  
(k) The regional systems of care authority shall apply to the department for approval and  
recognition as a regional stroke system. The department, with the statewide stroke care advisory  
subcommittee and state EMS coordination committee, shall review the regional stroke system  
application for approval every 3 years.  
(l) The establishment of the regional stroke system does not limit the transfer or transport of  
stoke patients between regions of the state.  
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(m) Require stroke triage protocols, which are established and adopted by local MCA and  
regional stroke systems and developed based on triage criteria prescribed by the department on  
the recommendation of the statewide stroke care advisory subcommittee and state EMS  
coordination committee, and following the procedures established by the department under  
section 20919(3) of the code, MCL 333.20919.  
(n) Develop a statewide stroke verification process based on the verification standards of a  
CMS recognized professional certifying organization for a predetermined period of time.  
(o) Establish a mechanism for periodic re-designation of stroke centers.  
(p) Develop a comprehensive statewide stroke data collection system.  
(q) Formulate recommendations for the development of performance improvement plans by the  
regional stroke systems, consistent with those in R 330.260.  
(r) Develop a process for stroke system performance improvement, including responsibility for  
monitoring compliance with standards, maintaining confidentiality, and providing periodic  
review of stroke center standards set forth by nationally recognized professional review  
organizations. The following standards are incorporated by reference in these rules, as specified  
in R 330.259, and R 330.260.  
(t) Develop a process for the evaluation of stroke system effectiveness based on standards under  
R 330.260.  
(u) Coordinate and integrate appropriate stroke risk reduction strategies and programs.  
(v) Support the state stroke system of care and provide resources to carry out its responsibilities  
and functions.  
(w) Support the training and education needs and resources of stroke care personnel throughout  
this state.  
(2) The department may deny, suspend, or revoke designation of a stroke center on a finding  
including, but not limited to, any 1 of the following:  
(a) Failure to comply with the rules or healthcare facilities rules and regulations, or both.  
(b) Willful preparation or filing of false reports or records.  
(c) Fraud or deceit in obtaining or maintaining designation status.  
(d) Failure to meet designation criteria established in these rules.  
(e) Unauthorized disclosure of medical or other confidential information.  
(f) Alteration or inappropriate destruction of medical records.  
(g) The healthcare facility no longer has the resources required to comply with the current level  
of designation conferred.  
(h) The healthcare facility no longer cares for stroke patients.  
(i) A department-approved stroke care verification body has determined that the stroke center  
no longer meets their stroke center verification criteria.  
(j) Identified deficiencies are not remediated in the allowable timeframe.  
(3) The department shall provide a notice of disciplinary action including, but not limited to an  
intent to deny, suspend, or revoke a stroke center designation and provide for an appeals process  
under sections 71 to 87 of the administrative procedure act of 1969, 1969 PA 306, MCL 24271  
to 24.287.  
(4) In developing a statewide stroke care system, the department shall consider all the  
following factors:  
(a) Efficient implementation and operation.  
(b) Decrease in morbidity and mortality.  
(c) Cost effective implementation.  
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(d) Incorporation of national standards.  
(e) Availability of money for implementation.  
R 330.255 Stroke center verification; designation and re-designation.  
Rule 5. (1) A healthcare facility that intends to hold itself out to provide stroke care shall not  
self-designate itself as a stroke center, advertise, or otherwise describe itself as a “designated  
stroke center” without obtaining and maintaining a designation from the department. Facilities  
that are not designated by the department will be noted as a non-designated healthcare facility.  
(2) The department shall re-designate the stroke care capabilities of each stroke center based on  
verification and designation requirements in effect when the re-designation takes place.  
(3) To obtain designation as a stroke center, the healthcare facility shall apply to the  
department. A healthcare facility has a right to an administrative hearing if denied a specific  
stroke center level designation.  
(4) The department shall designate the existing stroke care resources of all participating  
healthcare facilities in this state, based on the following categories:  
(a) A level I or comprehensive stroke center shall provide evidence of current certification by a  
department-approved, CMS-recognized professional certifying organization that the healthcare  
facility has the resources required to be certified as meeting all the criteria, or subsequent  
equivalent certification as approved by the department, with the advice of the stroke advisory  
subcommittee, for an accredited comprehensive stroke center under R 330.254(1)(e). All the  
following apply to a level I stroke center:  
(i) Comply with data submission requirements in R 330.258 and R 330.259.  
(ii) Participate in coordinating and implementing regional stroke risk reduction plans.  
(iii) Participate in the regional performance improvement process.  
(iv) Provide staff assistance to the department for the designation and verification process of  
stroke centers when applicable under R 330.254(1)(e).  
(b) A level II or thrombectomy capable stroke center shall provide evidence of current  
certification by a department-approved, CMS-recognized professional certifying organization  
that the healthcare facility has the resources required to be certified as meeting all the criteria, or  
subsequent equivalent certification as approved by the department with the advice of the stroke  
advisory subcommittee, for a certified thrombectomy capable stroke center under R 330.254  
(1)(e), and all the following:  
(i) Comply with data submission requirements in R 330.258 and R 330.259.  
(ii) Participate in coordinating and implementing regional stroke risk reduction plans.  
(iii) Participate in the regional performance improvement process.  
(iv) Provide staff assistance to the department for the designation and verification process of  
stroke centers when applicable under R 330.254(1)(e).  
(c) A level III or primary stroke center shall provide current certification by a department-  
approved, CMS-recognized professional certifying organization that the healthcare facility has  
the resources required to be certified as meeting all the criteria, or subsequent equivalent  
certification as approved by the department with the advice of the stroke advisory subcommittee,  
for a certified primary stroke center under R 330.254(1)(e), and all the following:  
(i) Comply with data submission requirements in R 330.258 and R 330.259.  
(ii) Participate in coordinating and implementing regional stroke risk reduction plans.  
(iii) Participate in the regional performance improvement process.  
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(d) A level IV or acute stroke ready hospital stroke center shall provide current certification by  
a department-approved, CMS-recognized professional certifying organization that the healthcare  
facility has the resources required to be certified as meeting all the criteria, or subsequent  
equivalent certification as approved by the department with the advice of stroke advisory  
subcommittee, for a certified acute stroke ready hospital under R 330.254(1)(e). All the  
following apply to the level IV stroke center:  
(i) Comply with data submission requirements in R 330.258 and R 330.259.  
(ii) Participate in coordinating and implementing regional stroke risk reduction plans.  
(iii) Participate in the regional performance improvement process.  
(5) Healthcare facilities wishing to be re-designated as a level I or comprehensive stroke center  
shall independently obtain certification by a department-approved, CMS-recognized professional  
certifying organization at that level, and comply with the standards under R 330.254(1)(e), and  
all the following:  
(a) Comply with data submission requirements in R 330.258 and R 330.259.  
(b) Participate in coordinating and implementing regional stroke risk reduction plans.  
(c) Participate in the regional performance improvement process.  
(d) Provide staff assistance to the department for the designation and verification process of  
stroke centers when applicable under R 330.254(1)(e).  
(6) Healthcare facilities wishing to be re-designated as a level II or thrombectomy capable  
stroke center shall independently obtain certification by a department-approved, CMS-  
recognized professional certifying organization at that level, and comply with the standards  
under R 330.254(1)(e) and all of the following:  
(a) Comply with data submission requirements in R 330.258 and R 330.259.  
(b) Participate in coordinating and implementing regional stroke risk reduction plans.  
(c) Participate in the regional performance improvement process.  
(d) Provide staff assistance to the department for the designation and verification process of  
stroke centers when applicable under R 330.254(1)(e).  
(7) Healthcare facilities wishing to be re-designated as a level III or primary stroke center shall  
independently obtain certification by a department-approved, CMS-recognized professional  
certifying organization at that level and comply with the standards under R 330.254(1)(e), and  
the following:  
(a) Comply with data submission requirements in R 330.258 and R 330.259.  
(b) Participate in coordinating and implementing regional stroke risk reduction plans.  
(c) Participate in the regional performance improvement process.  
(8) Healthcare facilities wishing to be re-designated as a level IV or acute stroke ready stroke  
center shall independently obtain certification by a department-approved CMS recognized  
professional certifying organization at that level and comply with the under R 330.254 (1)(e),  
and the following:  
(a) Comply with data submission requirements in R 330.258 and R 330.259.  
(b) Participate in coordinating and implementing regional stroke risk reduction plans.  
(c) Participate in the regional performance improvement process.  
(9) A hospital may apply to the department for a one-time, temporary-time limited status as a  
provisional stroke center by submitting an application that includes evidence that the hospital  
meets the department-approved criteria for a provisional stroke center at the level that the  
hospital is applying. A hospital applying for provisional stroke center status requires the  
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recommendation of the stroke network system and notification to the statewide stroke advisory  
committee.  
(10) The department may, with the advice and recommendations of the statewide stroke care  
advisory committee and state EMS coordination committee, modify the criteria or establish  
additional levels of stroke care resources as appropriate to maintain an effective state stroke  
system of care and protect the public welfare. The department shall not establish criteria for the  
purpose of limiting the number of healthcare facilities that qualify for a particular stroke center  
level of designation under these rules.  
R 330.256 Triage and transport.  
Rule 6. (1) The department, with the advice and recommendations of the statewide stroke care  
advisory subcommittee and state EMS coordinating committee, shall develop recommendations,  
based on standards in these rules, R 330.254, R 330.261, R 330.262, and R 330.263 for protocols  
that are established and adopted by local MCAs for the triage, transport, and inter-facility  
transfer of stroke patients to the appropriate stroke centers.  
(2) The standards under R 330.254, R 330.261, R 330.262, and R 330.263 for the triage,  
transport, and the inter-facility transfer of stroke patients must provide recommended minimum  
standards of care for protocols that are established and adopted by local MCAs and that must be  
utilized in the care during transport of stroke patients. On an annual basis, or as needed, the  
department shall review and update these recommended minimum standards with the advice and  
recommendations of the statewide stroke care advisory subcommittee and the state EMS  
coordination committee.  
(3) The department, with the advice and recommendations of the statewide stroke care advisory  
subcommittee and state EMS coordinating committee, shall create regional stroke systems that  
are responsible for developing triage and transport procedures within that geographical area. The  
triage and transport procedures must include both of the following:  
(a) Each regional stroke system must be integrated into the regional systems of care authority  
created within the existing trauma regions under R 325.132.  
(b) Each regional stroke system may create its own triage and transport criteria and protocols,  
destination criteria and protocols, and inter-facility transfer criteria and protocols, established  
and adopted by local MCAs, provided they meet or exceed the standards that are incorporated  
under R 330.261, R 330.262, and R 330.263, and are reviewed by the quality assurance task  
force and approved by the department. This may include coordination of triage and transport  
criteria and protocols, established, and adopted by local MCAs, across geographic regions, if in  
the best interest of providing optimal stroke care to patients.  
R 330.257 Stroke care regions.  
Rule 7. (1) The department, with the advice and recommendations of the statewide stroke care  
advisory subcommittee and state EMS coordination committee, shall support the establishment  
and operational activities of the regional stroke system of care through the commitment of  
resources.  
(2) Each region shall establish a regional stroke system of care as prescribed by this part.  
(3) All MCA areas or regions shall participate in the regional stroke care system, and life  
support agencies that care for stroke patients shall be offered membership on the regional stroke  
care advisory council. Regional stroke care advisory councils must be operated in a manner that  
maximizes inclusion of their constituents. The following requirements must be met:  
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(a) Quarterly, a regional stroke system of care shall submit evidence of ongoing activity, such  
as meeting notices and minutes, to the department. Annually, the regional stroke system of care  
shall file a report with the department that describes ongoing progress toward regional stroke  
care plan implementation and includes evidence that members of the regional stroke care  
advisory council are currently involved in stroke care.  
(b) The regional stroke system of care shall develop a regional stroke care plan. The plan is  
subject to review by the statewide stroke care advisory committee and the state EMS  
coordination committee for recommendation and approval by the department.  
(c) The department shall review the plan to ensure that it contains at a minimum, all the  
following:  
(i) All counties within the regional stroke system are included unless a specific county, or  
portion thereof, has been aligned within an adjacent system, and all healthcare entities, MCAs,  
and life support agencies have been given an opportunity to participate in the planning process.  
(ii) All the following components are addressed:  
(A) Stroke risk reduction.  
(B) Communications.  
(C) Regional performance improvement.  
(D) Stroke education.  
(E) Infrastructure.  
(F) Continuum of care.  
(4) Each regional stroke system of care shall appoint a RPSRO.  
(5) Each regional stroke care advisory council shall develop performance improvement plans  
that are based on standards under R 330.260. The statewide stroke care advisory subcommittee  
and state EMS coordination committee shall annually review the performance improvement plan  
and make recommendations to the department.  
(6) Recommendations developed and proposed for implementation by a regional stroke care  
advisory council must meet or exceed those that are established by the department, with the  
advice and recommendations of the statewide stroke care advisory subcommittee and state EMS  
coordination committee, as based on standards under R 330.254(1)(n) and R 330.254(1)(o).  
(7) The department shall recognize the regional stroke system once it approves a completed  
regional stroke plan. The regional stroke system approval process must consist of the following  
phases:  
(a) The first phase is the application phase, which begins with the submission to the department  
of a completed regional plan for the regional stroke system.  
(b) The second phase is the review phase, which begins after the receipt of the regional plan  
and ends with a department recommendation to approve the regional stroke system.  
(c) The third phase is the final phase, with the department making a final decision regarding the  
regional stroke system plan. This phase also includes an appeal procedure for the denial of an  
approval of application in accordance with the department’s administrative hearings  
requirements.  
(8) If the application phase results in a recommendation to the department for approval by the  
statewide stroke care advisory subcommittee and the state EMS coordination committee, and the  
department approves, the department shall notify the regional stroke system applicant of  
recommended action within 90 days after receipt by the department.  
(9) After approval, a regional stroke care advisory council shall implement the plan to include  
both the following:  
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(a) Education of all entities about the plan components.  
(b) On-going review of resources, process, and outcome data.  
(10) The regional stroke system approval is effective for 3 years.  
R 330.258 Data collection.  
Rule 8. (1) The department, with the advice and recommendations of the statewide stroke care  
advisory subcommittee and state EMS coordination committee, shall develop and maintain a  
statewide stroke registry. The registry must contain all the following:  
(a) Standard stroke data elements and definitions as a minimum set of elements for data  
collection, with the addition of elements as recommended by the statewide stroke care advisory  
subcommittee and approved by the department, including subsequent amendments and editions.  
(b) A plan for data that does all of the following:  
(i) Notifies partners of data dictionary changes and new iterations annually.  
(ii) Defines the data validation process for designated stroke center data submissions to the  
statewide stroke registry.  
(iii) Participates in state data collaboration activities.  
(iv) Establishes and maintains processes for the following:  
(A) Submitting data related to stroke responses to the statewide stroke registry according to  
the data submission timelines.  
(B) Monitoring national standards, regional issues, stroke center, and RPSRO to determine  
the need for additional data metrics needed for system function.  
(C) For those stroke responses that met the inclusion criteria identified for data submission,  
submitting all of the following:  
(1) Standard stroke data elements approved by the department with the advice and  
recommendations of statewide stroke care advisory subcommittee.  
(2) Subsequent amendments or additions recommended by the statewide stroke care advisory  
subcommittee.  
(v) Developing annual reports using regional and state data defined by the statewide stroke  
care advisory subcommittee that assess the state stroke system of care and regional stroke  
systems.  
(vi) Evaluating and importing additional data from existing databases as needed.  
(vii) Supporting and evaluating probabilistic and deterministic data linkages.  
(2) The department shall support the data collection and analysis process.  
(3) Both of the following apply to stroke center participation in data submission:  
(a) All designated stroke centers shall participate in data submission.  
(b) Participation as appropriate in the RPSRO, as provided in sections 1 to 3 of 1967 PA 270,  
MCL 331.531 to 331.533.  
R 330.259 Statewide stroke registry.  
Rule 9. (1) The purpose of the stroke registry is to collect and analyze system data to evaluate  
the delivery of stroke care, develop stroke risk reduction initiatives, and provide resources for  
stroke research and education.  
(2) The department shall coordinate data collected by the stroke centers and EMS providers.  
The department shall develop and publish a data submission manual that specifies all of the  
following:  
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(a) Data elements and definitions, including the standards under R 330.258(1)(a) and the  
following:  
(i) Definitions of what constitutes a reportable stroke case.  
(ii) Method of submitting data to the department.  
(iii) Timetables for data submission.  
(iv) Data submission format.  
(v) Protections for individual record confidentiality.  
(b) Notification of stroke centers of the required registry data sets and to update the stroke  
centers and providers as necessary, when the registry data set changes.  
(c) Specification of both the process and timelines for stroke center submission of data to the  
department.  
(3) All healthcare facilities shall submit to the department stroke data determined by the  
department to be required for the department’s operation of the statewide stroke registry. The  
department shall prescribe and provide both of the following:  
(a) Standard reporting mechanisms used by all healthcare facilities.  
(b) The form and content of records maintained and the information to be reported to the  
department.  
(4) The department and regional stroke care advisory councils shall use the stroke registry data  
to identify and evaluate regional stroke care and to prepare reports and analyses as requested by  
regional stroke advisory councils, the statewide stroke care advisory subcommittee, or the state  
EMS coordination committee.  
R 330.260 Regional performance improvement.  
Rule 10. (1) Each regional stroke system shall develop and implement a regional stroke care  
performance improvement program. This program must include the standards under R  
330.254(1)(d) and R 330.257(5) and the development of an annual process for reporting to the  
department a review of all region-wide policies, procedures, and protocols.  
(2) Each regional stroke system is responsible for monitoring, assessing, and evaluating the  
system to improve stroke care, reduce death and disability, surveillance of stroke incidence and  
implementation of stroke risk reduction initiatives.  
(3) Each regional stroke system shall appoint an RPSRO.  
(4) Deviations from protocols established and adopted by local MCAs and approved by the  
department for stroke patients must be addressed through a documented stroke care performance  
improvement process established by a PSRO.  
(5) Each regional stroke care advisory council shall observe the confidentiality provisions of 45  
CFR Part 164, the health insurance portability and accountability act of 1996, Public Law 104-  
191, the data confidentiality provisions under the code, and any confidentiality provisions  
established by the RPSRO.  
(6) The performance improvement process must include the standards under R 330.254(1)(d),  
and include all of the following system components to be evaluated:  
(a) Components of the regional stroke care plan.  
(b) Triage criteria and effectiveness.  
(c) Stroke center diversion.  
(d) Data driven provision of care defined by available data metrics supported by the region, the  
statewide stroke care advisory subcommittee, and the department.  
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(7) Each regional stroke system is responsible for the ongoing evaluation of the stroke system  
of care. Accordingly, each region shall develop a procedure for receiving information from the  
regional stroke care system constituents on the implementation of various components of that  
region’s stroke care system, and include the standards under R 330.254(1)(e), and include all the  
following:  
(a) Components of the regional stroke care plan.  
(b) Triage criteria, and effectiveness.  
(c) Stroke center diversion.  
(d) Data analytics as defined by the department with the advice of the statewide stroke care  
advisory subcommittee.  
(8) Based on information received by the region in the evaluation process, the region shall  
annually prepare a report containing results of the evaluation and a performance improvement  
plan, if needed. The report must be made available to all regional stroke system constituents.  
(9) The region shall ensure that all stroke centers participate in this annual evaluation process  
and encourage all other hospitals that treat stroke patients to participate. The region shall not  
release specific information related to an individual patient or practitioner. Aggregate system  
performance information and evaluation must be available for review.  
R 330.261 Destination protocols.  
Rule 11. Local MCAs shall develop and submit stroke patient destination protocols to the  
bureau of emergency preparedness, EMS, and systems of care for review by the statewide quality  
assurance task force appointed under section 20916 of the code, MCL 333.20916. After review  
and approval by the department, the MCA shall formally adopt and implement the protocol. The  
following factors must be used in evaluating destination protocols:  
(a) An evidence-based validated stroke assessment tool.  
(b) Stroke patients shall not be transported to a healthcare facility that does not participate in  
the state stroke care system unless there is no other reasonable alternative available.  
(c) Stroke patients shall be transported to the closest appropriate stroke center as identified in  
regional and local medical control protocols.  
(d) If a level I, level II or level III stroke center is not within a reasonable distance from the  
incident scene, the stroke patient shall be transported to a level IV stroke center.  
(e) Each region shall make appropriate determinations for stroke patient destination based on  
what is best for the patient.  
(f) In areas of this state close to state borders, the most appropriate stroke center may be out of  
this state. If possible, transport stroke patients within state borders. Local protocols must address  
this issue.  
R 330.262 Stroke patient inter-facility transfer protocols.  
Rule 12. (1) All designated stroke centers shall maintain inter-facility transfer protocols for  
stroke patients that are consistent with regional and local medical control protocol and are  
compliant with 42 USC 1395dd.  
(2) All level IV stroke centers shall develop and implement formal policies based on published  
guidelines for the transfer of stroke patients who need care at a level III, level II, or level I stroke  
center.  
(3) All level III stroke centers shall develop and implement formal policies based on published  
guidelines for the transfer of stroke patients who need care at a level II or level I stroke center.  
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(4) All level II stroke centers shall develop and implement formal policies based on published  
guidelines for the transfer of stroke patients who need care at a level I stroke center.  
(5) Stroke patients shall be transported to a hospital designated as a stroke center.  
R 330.263 Criteria for transfer protocols; criteria.  
Rule 13. (1) Designated stroke centers shall contact the department for current stroke patient  
transfer guidelines.  
(2) Stroke care, including stroke bypass, must be provided to patients as necessary pursuant to  
42 USC 1395dd or other applicable laws.  
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