Current through Register Vol. 49, No. 18, September 16, 2024
(1) General Standards for Stroke Center
Designation.
(A) The stroke center board of
directors, administration, medical staff, and nursing staff shall demonstrate a
commitment to quality stroke care. Methods of demonstrating the commitment
shall include, but not be limited to, a board resolution that the hospital
governing body agrees to establish policy and procedures for the maintenance of
services essential for a stroke center; assure that all stroke patients will
receive medical care at the level of the hospital's designation; commit the
institution's financial, human, and physical resources as needed for the stroke
program; and establish a priority admission for the stroke patient to the full
services of the institution. (I-R, II-R, III-R, IV-R)
(B) Stroke centers shall agree to accept all
stroke patients appropriate for the level of care provided at the hospital,
regardless of race, sex, creed, or ability to pay. (I-R, II-R, III-R,
IV-R)
(C) The stroke center shall
demonstrate evidence of a stroke program. The stroke program shall be available
twenty-four (24) hours a day, seven (7) days a week to evaluate and treat
stroke patients. (I-R, II-R, III-R, IV-R)
1.
The stroke center shall maintain a stroke team that at a minimum shall consist
of-
A. A core team which provides
administrative oversight and includes:
(I) A
physician experienced in diagnosing and treating cerebrovascular disease
(usually the stroke medical director); and (I-R, II-R, III-R, IV-R)
(II) At least one (1) other health care
professional or qualified individual credentialed in stroke patient care
(usually the stroke program manager/coordinator); (I-R, II-R, III-R,
IV-R)
B. A stroke call
roster that provides twenty-four (24) hours a day, seven (7) days a week
neurology service coverage. The call roster identifies the physicians or
qualified individuals on the schedule that are available to manage and
coordinate emergent, urgent, and routine assessment, diagnosis, and treatment
of stroke patients. A level I stroke center call roster shall include, but not
be limited to, the emergency department physician, neuro-interventionalist,
neurologist, and others as appropriate. A level II stroke center call roster
shall include, but not be limited to, the emergency department physician, a
physician with experience and expertise in diagnosing and treating patients
with cerebrovascular disease, and others as appropriate. The level III stroke
center call roster shall include, but not be limited to, the emergency
department physician and others as appropriate. A level IV stroke center call
roster shall include, but not be limited to, the emergency department physician
and other qualified individuals as appropriate. (I-R, II-R, III-R, IV-R)
(I) This coverage shall be available from
notification of stroke patients according to the response requirements as set
out below-
(a) Level I and II stroke centers
shall have this coverage available within fifteen (15) minutes of notification
of a stroke patient; and (I-R, II-R)
(b) Level III and IV stroke centers shall
have a regional networking agreement with a level I or level II stroke center
for telephone consult or telemedicine consultation available within fifteen
(15) minutes of notification of a stroke patient; and (III-R, IV-R)
C. A clinical team
appropriate to the center level designation that may include, but not be
limited to, members of the stroke call roster, neurologists, physicians with
expertise caring for stroke patients, neuro-interventionalists, neurosurgeons,
anesthesiologists, intensivists, emergency department physicians, and other
stroke center clinical staff as applicable. (I-R, II-R, III-R, IV-R)
2. The stroke center shall have a
peer review system to review stroke cases respective of the stroke center's
designation. (I-R, II-R, III-R, IV-R)
3. The stroke team members shall have
appropriate experience to maintain skills and proficiencies to care for stroke
patients. The stroke center shall maintain evidence that it meets the following
requirements by documenting the following:
A.
A list of all stroke team members; (I-R, II-R, III-R, IV-R)
B. Position qualifications and completion of
continuing education requirements by stroke team members as set forth in
sections (1), (2), and (4) of this rule; (I-R, II-R, III-R, IV-R)
C. Management of sufficient numbers of stroke
patients by the stroke team members in order to maintain their stroke skills;
(I-R, II-R, III-R, IV-R)
D.
Participation by the core team and members of the stroke call roster in at
least half of the regular, ongoing stroke program peer review system meetings
as shown in meeting attendance documents. The stroke medical director shall
disseminate the information and findings from the peer review system meetings
to the stroke call roster members and the core team and document such
dissemination; (I-R, II-R, III-R, IV-R)
E. Participation by stroke team members in at
least half of the regular, ongoing stroke program performance improvement and
patient safety meetings and documentation of such attendance in the meeting
minutes and/or meeting attendance documents. The stroke medical director shall
disseminate the information and findings from the performance improvement and
patient safety meetings to the stroke team members and document such
dissemination. If a stroke team member is unable to attend a stroke program
performance improvement and patient safety meeting, then the stroke team member
shall send an appropriate representative in his/her place; (I-R, II-R, III-R,
IV-R)
F. Maintenance of skill
levels in the management of stroke patients by the stroke team members as
required by the stroke center and the stroke medical director and documentation
of such continued experience; (I-R, II-R, III-R, IV-R)
G. Review of regional outcome data on quality
of patient care by the stroke team members as part of the stroke center's
performance improvement and patient safety process; and (I-R, II-R, III-R,
IV-R)
H. Evidence of a written
agreement between a level III stroke center and a level I or II stroke center
when a level III stroke center has a supervised relationship with a physician
affiliated with a level I or II stroke center. A level III stroke center which
provides lytic therapy to stroke patients may have an established plan for
admitting and caring for stroke patients under a supervised relationship with a
physician affiliated with a level I or II stroke center. This supervised
relationship shall consist of a formally established and pre-planned
relationship between the centers in which a physician from a level I or level
II center supervises a physician in a level III center in the evaluation of a
stroke patient for lytic therapy and the care of the patient postlytic therapy
in certain circumstances where that level III center does not transfer the
patient to a higher level stroke center. In this setting, management decisions,
including, but not limited to, administration of lytic therapy, transfer or
non-transfer of patient, and postlytic therapy shall be made jointly between
the supervising and supervised physicians. Care protocols and pathways for
patients that fall into this category shall be established by both parties at
the outset of the establishment of the relationship. This supervised
relationship shall be established by written agreement and detail the
supervision of patient care. This written agreement may also include, but not
be limited to, observation of patient care, review of level III stroke center's
patient encounters, review of level III center's outcomes, evaluation of the
level III center's process pertaining to stroke patients, and lytic therapy and
guidance on methods to improve process, performance, and outcomes.
4. The stroke center shall
maintain a multidisciplinary team, in addition to the stroke team, to support
the care of stroke patients. (I-R, II-R, III-R, IV-R)
A. The multidisciplinary team shall include a
suitable representative from hospital units as appropriate for care of each
stroke patient. The hospital units represented on the multidisciplinary team
may include, but not be limited to: administration, emergency medical services,
intensive care unit, radiology, pharmacy, laboratory, stroke unit, stroke
rehabilitation, and discharge planning. (I-R, II-R, III-R, IV-R)
B. The multidisciplinary team members or
their representatives shall attend at least half of the stroke program
performance improvement and patient safety program meetings which shall be
documented in the meeting minutes and/or meeting attendance documents. (I-R,
II-R, III-R, IV-R)
(D) A level I stroke center shall provide the
services of a neuro-interventional laboratory staffed twenty-four (24) hours a
day, seven (7) days a week.
1. The staff of
the neuro-interventional laboratory, referred to as the neuro-interventional
laboratory team, shall consist of at least the following:
A. Neuro-interventional specialist(s); and
(I-R/PA)
B. Other clinical staff as
deemed necessary. (I-R/PA)
2. The stroke center neuro-interventional
laboratory team shall maintain core competencies annually as required by the
stroke center. (I-R/PA)
3. The
hospital credentialing committee shall document that the neuro-interventional
specialist(s) have completed appropriate training and conducted sufficient
neuro-interventional procedures. (I-R/PA)
4. The stroke center neuro-interventional
laboratory team shall remain up to date in their continuing education
requirements which are set forth in section (4) of this rule.
(I-R/PA)
5. Resuscitation equipment
shall be available in the neuro-interventional lab. (I-R)
(E) It is recommended that a level I stroke
center meet the volume for stroke patient cases that is required for
eligibility by The Joint Commission in its Advanced Certification of
Comprehensive Stroke Centers as posted on January 31, 2012, which is
incorporated by reference in this rule and is available at The Joint
Commission, One Renaissance Boulevard, Oakbrook Terrace, IL 60181 or on The
Joint Commission's website at
www.jointcommission.org. This rule does
not incorporate any subsequent amendments or additions.
(F) The stroke center shall appoint a
physician to serve as the stroke medical director. A stroke medical director
shall be appointed at all times with no lapses. (I-R, II-R, III-R, IV-R)
1. A level I stroke medical director shall
have appropriate qualifications, experience, and training. A board-certified or
board-admissible neurologist or other neuro-specialty trained physician is
recommended. If the stroke medical director is board-certified or
board-admissible, then one (1) of the following additional qualifications shall
be met and documented. If the stroke medical director is not board-certified,
then two (2) of the following additional qualifications shall be met and
documented:
A. Completion of a stroke
fellowship; (I-R)
B. Participation
(as an attendee or faculty) in one (1) national or international stroke course
or conference each year or two (2) regional or state stroke courses or
conferences each year; or (I-R)
C.
Five (5) or more peer-reviewed publications on stroke. (I-R)
2. A level II stroke medical
director shall have appropriate qualifications, experience, and training. A
board-certified or board-admissible physician with training and expertise in
cerebrovascular disease is recommended. If the stroke medical director is
board-certified or board-admissible, then one (1) of the following additional
qualifications shall be met. If the stroke medical director is not
board-certified, then two (2) of the following additional qualifications shall
be met and documented:
A. Completion of a
stroke fellowship; (II-R)
B.
Participation (as an attendee or faculty) in one (1) national or international
stroke course or conference each year or two (2) regional or state stroke
courses or conferences each year; or (II-R)
C. Five (5) or more peer-reviewed
publications on stroke. (II-R)
3. A level III and IV stroke medical director
shall have the appropriate qualifications, experience, and training. A
board-certified or board-admissible physician is recommended. If the stroke
medical director is not board-certified or board-admissible, then the following
additional qualifications shall be met and documented:
A. Complete a minimum of four (4) hours of
continuing medical education (CME) in the area of cerebrovascular disease every
year; and (III-R)
B. Attend one (1)
national, regional, or state meeting every three (3) years in cerebrovascular
disease. Continuing medical education hours earned at these meetings can count
toward the four (4) required continuing medical education hours for level III
stroke medical directors. (III-R)
4. The stroke medical director shall meet the
department's continuing medical education requirements for stroke medical
directors as set forth in section (4) of this rule. (I-R, II-R,
III-R)
5. The stroke center shall
have a job description and organizational chart depicting the relationship
between the stroke medical director and the stroke center services. (I-R, II-R,
III-R, IV-R)
6. The stroke medical
director is encouraged to be a member of the stroke call roster. (I-R, II-R,
III-R, IV-R)
7. The stroke medical
director shall be responsible for the oversight of the education and training
of the medical and clinical staff in stroke care. This includes a review of the
appropriateness of the education and training for the practitioner's level of
responsibility. (I-R, II-R, III-R, IV-R)
8. The stroke medical director shall
participate in the stroke center's research and publication projects. (I-R)
(G) The stroke center
shall have a stroke program manager/coordinator who is a registered nurse or
qualified individual. The stroke center shall have a stroke program
manager/coordinator at all times with no lapses. (I-R, II-R, III-R, IV-R)
1. The stroke center shall have a job
description and organizational chart depicting the relationship between the
stroke program manager/coordinator and the stroke center services. (I-R, II-R,
III-R, IV-R)
2. The stroke program
manager/coordinator shall-
A. Meet continuing
education requirements as set forth in section (4) of this rule; and (I-R,
II-R, III-R, IV-R)
B. Participate
in the performance improvement and patient safety program. (I-R, II-R, III-R,
IV-R)
(H) The
stroke center shall have a specific and well-organized system to notify and
rapidly activate the stroke team to evaluate patients presenting at the stroke
center with symptoms suggestive of an acute stroke. (I-R, II-R, III-R,
IV-R)
(I) The stroke center shall
have a one- (1-) call stroke team activation protocol. This protocol shall
establish the following:
1. The criteria used
to triage stroke patients shall include, but not be limited to, the time of
symptom onset; (I-R, II-R, III-R, IV-R)
2. The persons authorized to notify stroke
team members when a suspected stroke patient is in route and/or when a
suspected stroke patient has arrived at the stroke center; (I-R, II-R, III-R,
IV-R)
3. The method for immediate
notification and the response requirements for stroke team members when a
suspected stroke patient is in route to the stroke center and/or when a
suspected stroke patient has arrived at the stroke center; and (I-R/IA,
II-R/IA, III-R/IA, IV-R/IA)
4. All
members of the stroke call roster shall comply with the availability and
response requirements per the stroke center's protocols and be in communication
within fifteen (15) minutes of notification of the patient. If not on the
stroke center's premises, stroke call roster members who are on call shall
carry electronic communication devices at all times to permit contact by the
hospital. It is recommended that one (1) member of the stroke team, per stroke
center protocol, be at the patient's bedside within fifteen (15) minutes of
notification of the patient. (I-R, II-R, III-R, IV-R)
(J) The stroke center shall have a
fibrinolysis protocol for cases when fibrinolysis is achievable. (I-R, II-R,
III-R)
(K) The stroke center shall
have transfer agreements between referring and receiving facilities that
address the following:
1. A one- (1-) call
transfer protocol that establishes the criteria used to triage stroke patients
and identifies persons authorized to notify the designated stroke center; and
(I-R, II-R, III-R, IV-R)
2. A rapid
transfer process in place to transport a stroke patient to a higher level of
stroke care when needed. (II-R, III-R, IV-R)
(L) The stroke center shall have
rehabilitation services that are directed by a physician with board
certification in physical medicine and rehabilitation or by other properly
trained individuals (e.g., neurologist experienced in stroke rehabilitation).
(I-R, II-R)
(M) The stroke center
shall have consults for physical medicine and rehabilitation, physical therapy,
occupational therapy, and speech therapy requested and completed when deemed
medically necessary within forty-eight (48) hours of admission. (I-R,
II-R)
(N) The stroke center shall
demonstrate that there is a plan for adequate post-discharge and post-transfer
follow-up on stroke patients, including rehabilitation and repatriation, if
indicated. (I-R, II-R, III-R, IV-R)
(O) The stroke center shall maintain a stroke
patient log. The log information shall be kept for a period of five (5) years
and made available to the Department of Health and Senior Services (department)
during reviews for all stroke patients which contains the following:
1. Response times; (I-R, II-R, III-R,
IV-R)
2. Patient diagnosis; (I-R,
II-R, III-R, IV-R)
3.
Treatment/actions; (I-R, II-R, III-R, IV-R)
4. Outcomes; (I-R, II-R, III-R,
IV-R)
5. Number of patients; and
(I-R, II-R, III-R, IV-R)
6.
Benchmark indicators. (I-R, II-R, III-R, IV-R)
(P) The stroke center shall have a helicopter
landing area. (I-R, II-R, III-R, IV-R)
(Q) Stroke centers shall enter data into a
stroke registry as follows:
1. Stroke centers
shall submit data into the department's Missouri stroke registry on each stroke
patient who is admitted to the stroke center, transferred out of the stroke
center, or dies as a result of the stroke (independent of hospital admission or
hospital transfer status). The data required to be submitted into the Missouri
stroke registry by the stroke centers is listed and explained in the document
entitled "Time Critical Diagnosis Stroke Center Registry Data Elements," dated
March 1, 2012, which is incorporated by reference in this rule and is available
at the Missouri Department of Health and Senior Services, PO Box 570, Jefferson
City, MO 65102-0570 or on the department's website at
www.health.mo.gov. This rule does not
incorporate any subsequent amendments or additions.
The data shall be submitted electronically into the Missouri
stroke registry via the department's website at www.health.mo.gov; or (I-R, II-R, III-R,
IV-R)
2. Stroke centers
shall submit data into a national data registry or data bank capable of being
used by the stroke center to perform its ongoing performance improvement and
patient safety program requirements for its stroke patients. The stroke center
shall submit data for each data element included in the national data registry
or data bank's data system; (I-R, II-R, III-R, IV-R)
3. The data required in paragraphs (1)(Q)1.
and 2. above shall be submitted electronically into the stroke registry on at
least a quarterly basis for that calendar year. Stroke centers have ninety (90)
days after the quarter ends to submit the data electronically into the stroke
registry; (I-R, II-R, III-R, IV-R)
4. The data submitted by the stroke centers
shall be complete and current; and (I-R, II-R, III-R, IV-R)
5. The data shall be managed in compliance
with the confidentiality requirements and procedures contained in section
192.067, RSMo. (I-R, II-R,
III-R, IV-R)
(R) A stroke
center shall maintain a diversion protocol for the stroke center that is
designed to allow best resource management within a given area. The stroke
center shall create criteria for diversion in this diversion protocol and shall
detail a performance improvement and patient safety process in the diversion
protocol to review and validate the criteria for diversion created by the
stroke center. The stroke center shall also collect, document, and maintain
diversion information that includes at least the date, length of time, and
reason for diversion. This diversion information shall be readily retrievable
by the stroke center during a review by the department and shall be kept by the
stroke center for a period of five (5) years. (I-R, II-R, III-R,
IV-R)
(2) Medical Staffing
Standards for Stroke Center Designation.
(A)
The stroke center's medical staff credentialing committee shall provide a
delineation of privileges for neurologists, neurosurgeons, and
neuro-interventionalists, as applicable to the stroke center. (I-R,
II-R)
(B) The stroke center shall
credential and shall have the following types of physicians available as listed
below:
1. A neurologist shall be available
for consultation within fifteen (15) minutes of patient notification;
(I-R)
2. A physician with
experience and expertise in diagnosing and treating patients with
cerebrovascular disease shall be available for consultation within fifteen (15)
minutes of patient notification; (II-R)
3. A neurosurgeon as follows:
A. Neurosurgeon and back-up coverage on the
call roster; (I-R/PA)
B.
Neurosurgeon and back-up coverage on the call roster or available within two
(2) hours by transfer agreement if not on staff; and (II-R/PA)
C. The neurosurgery staffing requirement may
be fulfilled by a surgeon who has been approved by the chief of neurosurgery
for care of stroke patients and shall be capable of initiating measures to
stabilize the patient and perform diagnostic procedures; (I-R, II-R)
4. A neuro-interventional
specialist; (I-R/PA)
5. An
emergency department physician; (I-R/IH, II-R/IH, III-R/IH; IV-R/IA)
6. An internal medicine physician; (I-R/PA,
II-R/PA, III-R/PA)
7. A diagnostic
radiologist; and (I-R/IA, II-R/IA, III-R/IA)
8. An anesthesiologist. (I-R/PA, II-R/PA)
A. Anesthesiology staffing requirements may
be fulfilled by anesthesiology residents, certified registered nurse
anesthetists (CRNA), or anesthesia assistants capable of assessing emergent
situations in stroke patients and of providing any indicated treatment
including induction of anesthesia. When anesthesiology residents or CRNAs are
used to fulfill availability requirements, the staff anesthesiologist on call
will be advised and promptly available and present for all operative
interventions and emergency airway conditions. The CRNA may proceed with life
preserving therapy while the anesthesiologist is in route under the direction
of the neurosurgeon, including induction of anesthesia. An anesthesiologist
assistant shall practice only under the direct supervision of an
anesthesiologist who is physically present or immediately available as this
term is defined in section
334.400, RSMo. (I-R,
II-R)
(3) Standards for Hospital Resources and
Capabilities for Stroke Center Designation.
(A) The stroke center shall meet emergency
department standards listed below. (I-R, II-R, III-R, IV-R)
1. The emergency department staffing shall
meet the following requirements:
A. The
emergency department in the stroke center shall provide immediate and
appropriate care for the stroke patient; (I-R, II-R, III-R, IV-R)
B. A level I stroke center shall have a
medical director of the emergency department who shall be board-certified or
board-admissible in emergency medicine by the American Board of Medical
Specialties, the American Osteopathic Association Board of Osteopathic
Specialists, or the Royal College of Physicians and Surgeons of Canada;
(I-R)
C. A level II stroke center
shall have a medical director of the emergency department who shall be a
board-certified or board-admissible physician; (II-R)
D. A level III and IV stroke center shall
have a medical director of the emergency department who is recommended to be a
board-certified or board-admissible physician; (III-R, IV-R)
E. There shall be an emergency department
physician credentialed for stroke care by the stroke center covering the
emergency department twenty-four (24) hours a day, seven (7) days a week;
(I-R/IH, II-R/IH, III-R/IH, IV-R/IA)
F. The emergency department physician who
provides coverage shall be current in continuing medical education in the area
of cerebrovascular disease; (I-R)
G. There shall be a written policy defining
the relationship of the emergency department physicians to other physician
members of the stroke team; (I-R, II-R, III-R, IV-R)
H. Registered nurses in the emergency
department shall be current in continuing education requirements as set forth
in section (4) of this rule; (I-R)
I. All registered nurses assigned to the
emergency department shall be determined to be credentialed in the care of the
stroke patient by the stroke center within one (1) year of assignment and
remain current in continuing education requirements as set forth in section (4)
of this rule; and (I-R, II-R, III-R, IV-R)
J. The emergency department in stroke centers
shall have written care protocols for identification, triage, and treatment of
acute stroke patients that are available to emergency department personnel,
reviewed annually, and revised as needed. (I-R, II-R, III-R, IV-R)
2. Nursing documentation for the
stroke patient shall be on a stroke flow sheet approved by the stroke medical
director and the stroke program coordinator/manager. (I-R, II-R, III-R,
IV-R)
3. The emergency department
shall have at least the following equipment for resuscitation and life support
available to the unit:
A. Airway control and
ventilation equipment including:
(I)
Laryngoscopes; (I-R, II-R, III-R, IV-R)
(II) Endotracheal tubes; (I-R, II-R, III-R,
IV-R)
(III) Bag-mask resuscitator;
(I-R, II-R, III-R, IV-R)
(IV)
Sources of oxygen; and (I-R, II-R, III-R, IV-R)
(V) Mechanical ventilator; (I-R, II-R,
III-R)
B. Suction
devices; (I-R, II-R, III-R, IV-R)
C. Electrocardiograph (ECG), cardiac monitor,
and defibrillator; (I-R, II-R, III-R, IV-R)
D. Central line insertion equipment; (I-R,
II-R, III-R)
E. All standard
intravenous fluids and administration devices including intravenous catheters
and intraosseous devices; (I-R, II-R, III-R, IV-R)
F. Drugs and supplies necessary for emergency
care; (I-R, II-R, III-R, IV-R)
G.
Two- (2-) way communication link with emergency medical service (EMS) vehicles;
(I-R, II-R, III-R, IV-R)
H.
End-tidal carbon dioxide monitor; and (I-R, II-R, III-R, IV-R)
I. Temperature control devices for patient
and resuscitation fluids. (I-R, II-R, III-R IV-R)
4. The stroke center emergency department
shall maintain equipment following the hospital's preventive maintenance
schedule and document when this equipment is checked. (I-R, II-R, III-R,
IV-R)
(B) The stroke
center shall have a designated intensive care unit (ICU). (I-R, II-R)
1. The intensive care unit shall ensure
staffing to provide appropriate care of the stroke patient. (I-R, II-R)
A. The stroke center intensive care unit
shall have a designated intensive care unit medical director who has
twenty-four (24) hours a day, seven (7) days a week access to a physician
knowledgeable in stroke care and who meets the stroke call roster continuing
medical education requirements as set forth in section (4) of this rule. (I-R,
II-R)
B. The stroke center
intensive care unit shall have a physician on duty or available twenty-four
(24) hours a day, seven (7) days a week who is not the emergency department
physician. This physician shall have access to a physician on the stroke call
roster. (I-R/IA, II-R/IA)
C. The
stroke center intensive care unit shall have a one to one (1:1) or one to two
(1:2) registered nurse/patient ratio used for critically ill patients requiring
intensive care unit level care. (I-R, II-R)
D. The stroke center intensive care unit
shall have registered nurses in the intensive care unit who are current in
continuing education requirements as set forth in section (4) of this rule.
(I-R, II-R)
E. The stroke center
intensive care unit shall have registered nurses in the intensive care unit who
meet at least the following core credentials for care of stroke patients on a
yearly basis:
(I) Care of patients after
thrombolytic therapy; (I-R, II-R)
(II) Treatment of blood pressure
abnormalities with parenteral vasoactive agents; (I-R, II-R)
(III) Management of intubated/ventilated
patients; (I-R, II-R)
(IV) Detailed
neurologic assessment and scales (e.g., National Institutes of Health Stroke
Scale, Glasgow Coma Scale); (I-R, II-R)
(V) Care of patients with intracerebral
hemorrhage and subarachnoid hemorrhage at all level I centers and all level II
centers with neurosurgical capability; (I-R, II-R)
(VI) Function of ventriculostomy and external
ventricular drainage apparatus in all level I centers and all level II centers
with neurosurgical capability; and (I-R, II-R)
(VII) Treatment of increased intracranial
pressure in all level I centers and all level II centers with neurosurgical
capability. (I-R, II-R)
2. The stroke center intensive care unit
shall have written care protocols for identification and treatment of acute
stroke patients which are available to intensive care unit personnel, reviewed
annually, and revised as needed. (I-R, II-R)
3. The stroke center intensive care unit
shall have intensive care unit beds for stroke patients or, if space is not
available in the intensive care unit, the stroke center shall make arrangements
to provide the comparable level of care until space is available in the
intensive care unit. (I-R, II-R)
4.
The stroke center intensive care unit shall have equipment available for
resuscitation and to provide life support for the stroke patient. This
equipment shall include at least the following:
A. Airway control and ventilation equipment
including laryngoscopes, endotracheal tubes, bag-mask resuscitator, and a
mechanical ventilator; (I-R, II-R)
B. Oxygen source with concentration controls;
(I-R, II-R)
C. Cardiac emergency
cart, including medications; (I-R, II-R)
D. Telemetry, ECG capability, cardiac
monitor, and defibrillator; (I-R, II-R)
E. Electronic pressure monitoring and pulse
oximetry; (I-R, II-R)
F. End-tidal
carbon dioxide monitor; (I-R, II-R)
G. Patient weighing devices; (I-R,
II-R)
H. Drugs, intravenous fluids,
and supplies; and (I-R, II-R)
I.
Intracranial pressure monitoring devices. (I-R, II-R)
5. The intensive care unit shall check all
equipment according to the hospital preventive maintenance schedule and the
stroke center shall document when it is checked. (I-R, II-R)
(C) Level I and level II stroke
centers shall provide a stroke unit. A level III stroke center that has an
established plan for admitting and caring for stroke patients under a
supervised relationship with a level I or II stroke center pursuant to
subparagraph (1)(C)3.H. above shall also provide a stroke unit. (I-R, II-R,
III-R)
1. The stroke center shall have a
designated medical director for the stroke unit who has access to a physician
knowledgeable in stroke care and who meets the stroke call roster continuing
medical education requirements as set forth in section (4) of this rule. (I-R,
II-R, III-R)
2. The stroke center
stroke unit shall have a physician on duty or available twenty-four (24) hours
a day, seven (7) days a week who is not the emergency department physician.
This physician shall have access to a physician on the stroke call roster.
(I-R/IA, II-R/IA, III-R/IA)
3. The
stroke center stroke unit shall have registered nurses and other essential
personnel on duty twenty-four (24) hours a day, seven (7) days a week. (I-R,
II-R, III-R)
4. The stroke center
stroke unit shall have registered nurses who are current in continuing
education requirements as set forth in section (4) of this rule. (I-R, II-R,
III-R)
5. The stroke center stroke
unit shall annually credential registered nurses that work in the stroke unit.
(I-R, II-R, III-R)
6. The stroke
center stroke unit shall have written care protocols for identification and
treatment of acute stroke patients (e.g., lytic and postlytic management,
hemorrhagic conversion according to current best evidence) which are available
to stroke unit personnel, reviewed annually, and revised as needed. (I-R, II-R,
III-R)
7. The stroke center stroke
unit shall have equipment to support the care and resuscitation of the stroke
patient that includes at least the following:
A. Airway control and ventilation equipment
including:
(I) Laryngoscopes, endotracheal
tubes of all sizes; (I-R, II-R, III-R)
(II) Bag-mask resuscitator and sources of
oxygen; and (I-R, II-R, III-R)
(III) Suction devices; (I-R, II-R,
III-R)
B. Telemetry,
electrocardiograph, cardiac monitor, and defibrillator; (I-R, II-R,
III-R)
C. All standard intravenous
fluids and administration devices and intravenous catheters; and (I-R, II-R,
III-R)
D. Drugs and supplies
necessary for emergency care. (I-R, II-R, III-R)
8. The stroke center stroke unit shall
maintain equipment following the hospital preventive maintenance schedule and
document when it is checked. (I-R, II-R, III-R)
(D) The stroke center shall provide
radiological and diagnostic capabilities. (I-R, II-R, III-R)
1. The radiological and diagnostic
capabilities shall include a documented mechanism for prioritization of stroke
patients and timely interpretation to aid in patient management. (I-R, II-R,
III-R)
2. The radiological and
diagnostic capabilities shall include the following equipment and staffing
capabilities:
A. Angiography with
interventional capability available twenty-four (24) hours a day, seven (7)
days a week; (I-R/PA)
B.
Cerebroangiography technologist on call and available within thirty (30)
minutes for emergent procedures, and on call and available within sixty (60)
minutes for routine procedures, and available twenty-four (24) hours a day,
seven (7) days a week; (I-R)
C.
In-house computerized tomography; (I-R/IA, II-R/IA, III-R/IA)
D. Computerized tomography perfusion;
(I-R/IA)
E. Computerized tomography
angiography; (I-R/IA)
F.
Computerized tomography technologist; (I-R/IH, II-R/IH, III-R/IA)
G. Magnetic resonance imaging; (I-R,
II-R)
H. Magnetic resonance
angiogram/magnetic resonance venography; (I-R, II-R)
I. Magnetic resonance imaging technologist on
call and available within sixty (60) minutes, twenty-four (24) hours a day,
seven (7) days a week; (I-R, II-R)
J. Extracranial ultrasound; (I-R,
II-R)
K. Equipment and clinical
staff to evaluate for vasospasm available within thirty (30) minutes for
emergent evaluation, and available within sixty (60) minutes for routine
evaluation, and available twenty-four (24) hours a day, seven (7) days a week;
(I-R)
L. Transthoracic echo; (I-R,
II-R)
M. Transesophageal echo; and
(I-R, II-R)
N. Resuscitation
equipment available to the radiology department. (I-R, II-R, III-R)
3. The radiological and diagnostic
capabilities shall include adequate physician and nursing personnel available
with monitoring equipment to fully support the acute stroke patient and provide
documentation of care during the time the patient is physically present in the
radiology department and during transportation to and from the radiology
department. (I-R, II-R, III-R)
4.
The radiological and diagnostic capabilities shall include the stroke center
maintaining all radiology and diagnostic equipment according to the hospital
preventive maintenance schedule and documenting when it is checked. (I-R, II-R,
III-R)
(E) All level I
stroke centers shall have operating room personnel, equipment, and procedures.
Those level II stroke centers with neurosurgical capability shall also meet
operating room personnel, equipment, and procedure requirements. (I-R, II-R)
1. Operating room staff shall be available
twenty-four (24) hours a day, seven (7) days a week. (I-R/PA,
II-R/PA)
2. Registered nurses shall
annually maintain core competencies as required by the stroke center.
3. Operating rooms shall have at least the
following equipment:
A. Operating microscope;
(I-R, II-R)
B. Thermal control
equipment for patient and resuscitation fluids; (I-R, II-R)
C. X-ray capability; (I-R, II-R)
D. Instruments necessary to perform an open
craniotomy; (I-R, II-R)
E.
Monitoring equipment; and (I-R, II-R)
F. Resuscitation equipment available to the
operating room. (I-R, II-R)
4. The operating room shall maintain all
equipment according to the hospital preventive maintenance schedule and
document when it is checked. (I-R, II-R)
(F) All level I stroke centers shall meet
post-anesthesia recovery room (PAR) requirements listed below. Those level II
stroke centers with neurosurgical capability shall also have a post-anesthesia
recovery room and meet the requirements below-
1. The stroke center post-anesthesia recovery
room shall have registered nurses and other essential personnel on call and
available within sixty (60) minutes twenty-four (24) hours a day, seven (7)
days a week; (I-R, II-R)
2. The
stroke center post-anesthesia recovery room's registered nurses shall annually
maintain core competencies as required by the stroke center; (I-R,
II-R)
3. The stroke center
post-anesthesia recovery room shall have at least the following equipment for
resuscitation and to provide life support for the stroke patient:
A. Airway control and ventilation equipment
including laryngoscopes, endotracheal tubes of all sizes, bag-mask
resuscitator, sources of oxygen, and mechanical ventilator; (I-R,
II-R)
B. Suction devices; (I-R,
II-R)
C. Telemetry, ECG capability,
cardiac monitor, and defibrillator; (I-R, II-R)
D. All standard intravenous fluids and
administration devices, including intravenous catheters; and (I-R,
II-R)
E. Drugs and supplies
necessary for emergency care; and (I-R, II-R)
4. The stroke center post-anesthesia recovery
room shall maintain all equipment according to the hospital preventive
maintenance schedule and document when it is checked. (I-R, II-R)
(G) The stroke center shall have
clinical laboratory services available twenty-four (24) hours a day, seven (7)
days a week that meet the following requirements:
1. Written protocol to provide timely
availability of results; (I-R, II-R, III-R, IV-R)
2. Standard analyses of blood, urine, and
other body fluids; (I-R, II-R, III-R, IV-R)
3. Blood typing and cross-matching; (I-R,
II-R, III-R)
4. Coagulation
studies; (I-R, II-R, III-R, IV-R)
5. Comprehensive blood bank or access to a
community central blood bank and adequate hospital blood storage facilities;
(I-R, II-R, III-R)
6. Blood bank or
access to a community central blood bank and adequate hospital blood storage
facilities; (IV-R)
7. Blood gases
and pH determinations; (I-R, II-R, III-R, IV-R)
8. Blood chemistries; and (I-R, II-R, III-R,
IV-R)
9. Written protocol for
prioritization of the stroke patient with other time critical patients. (I-R,
II-R, III-R, IV-R)
(H)
The stroke center shall have support services to assist the patient's family
from the time of entry into the facility to the time of discharge and records
to document that these services were provided. (I-R, II-R, III-R, I
V-R)
(I) The stroke center shall
have a stroke rehabilitation program or a plan to refer those stroke patients
that require rehabilitation to another facility or community agency that can
provide necessary services. (I-R, II-R, III-R)
(4) Continuing Medical Education (CME) and
Continuing Education Standards for Stroke Center Designation.
(A) The stroke center shall ensure that staff
providing services to stroke patients receives required continuing medical
education and continuing education and document this continuing medical
education and continuing education for each staff member. The department shall
allow up to one (1) year from the date of the hospital's initial stroke center
designation for stroke center staff members to complete all of the required
continuing medical education and continuing education if the stroke center
staff complete and document that at least half of the required continuing
medical education and/or continuing education hours have been completed for
each stroke center staff member at the time of on-site initial application
review. The stroke center shall submit documentation to the department within
one (1) year of the initial designation date that all continuing medical
education and continuing education requirements for stroke center staff members
have been met in order to maintain the stroke center's designation. (I-R, II-R,
III-R)
(B) The stroke call roster
members shall complete the following continuing education requirements:
1. Level I core team members of the stroke
call roster shall complete a minimum of eight (8) hours of continuing education
in cerebrovascular disease every year, and it is recommended that a portion of
those hours shall be on stroke care. All other members of the stroke call
roster in level I stroke centers shall complete a minimum average of eight (8)
hours of continuing education in cerebrovascular disease every year, except for
physicians who are emergency medicine board certified or board eligible through
the American Board of Emergency Medicine (ABEM) or the American Osteopathic
Board of Emergency Medicine (AOBEM) and who are practicing in the emergency
department. This continuing education shall be reviewed for appropriateness to
the practitioner's level of responsibility by the stroke medical director; and
(I-R)
2. Level II core team members
of the stroke call roster shall complete a minimum of eight (8) hours of
continuing education in cerebrovascular disease every year, and it is
recommended that a portion of those hours be in stroke care. (II-R)
(C) The stroke medical director
shall complete the following continuing medical education requirements:
1. Level I and level II stroke medical
directors shall complete a minimum of eight (8) hours of continuing medical
education every year in the area of cerebrovascular disease; and (I-R,
II-R)
2. Level III stroke medical
directors shall complete a minimum of four (4) hours of continuing medical
education every year in the area of cerebrovascular disease. (III-R)
(D) The stroke center's stroke
program manager/coordinator shall complete the following continuing education
requirements:
1. Level I program
managers/coordinators shall-
A. Complete a
minimum of eight (8) hours of continuing education every year in
cerebrovascular disease. This continuing education shall be reviewed by the
stroke medical director for appropriateness to the stroke program
manager/coordinator's level of responsibility; and (I-R)
B. Attend one (1) national, regional, or
state meeting every two (2) years focused on the area of cerebrovascular
disease. If the national or regional meeting provides continuing education,
then that continuing education may count toward the annual requirement;
(I-R)
2. Level II program
managers/coordinators shall-
A. Complete a
minimum average of eight (8) hours of continuing education every year in
cerebrovascular disease. This continuing education shall be reviewed for
appropriateness by the stroke medical director to the stroke program
manager/coordinator's level of responsibility; and (II-R)
B. Attend one (1) national, regional, or
state meeting every three (3) years focused on the area of cerebrovascular
disease. If the national, regional, or state meeting provides continuing
education, then that continuing education may count toward the annual
requirement; and (II-R)
3. Level III center program
managers/coordinators shall complete a minimum average of four (4) hours of
continuing education in cerebrovascular disease every year. This continuing
education shall be reviewed by the stroke medical director for appropriateness
to the stroke program manager/coordinator's level of responsibility.
(III-R)
(E) Emergency
department personnel in stroke centers shall complete the following continuing
education requirements:
1. Emergency
department physicians in stroke centers shall complete-
A. Level I emergency department physicians
providing stroke coverage shall complete a minimum of two (2) hours of
continuing medical education in cerebrovascular disease every year, except for
physicians who are emergency medicine board certified or board eligible through
the American Board of Emergency Medicine (ABEM) or the American Osteopathic
Board of Emergency Medicine (AOBEM) and who are practicing in the emergency
department; (I-R)
2.
Registered nurses assigned to the emergency departments in stroke centers shall
complete-
A. Level I registered nurses shall
complete a minimum of two (2) hours of cerebrovascular disease continuing
education every year; and (I-R)
B.
Registered nurses shall maintain core competencies in the care of the stroke
patient annually as determined by the stroke center. Training to maintain these
competencies may count toward continuing education requirements. (I-R, II-R,
III-R, IV-R)
(F) Registered nurses assigned to the
intensive care unit in the stroke centers who care for stroke patients shall
complete the following continuing education requirements:
1. Level I intensive care unit registered
nurses shall complete a minimum of eight (8) hours of cerebrovascular related
continuing education every year; and (I-R)
2. The stroke medical director shall review the
continuing education for appropriateness to the practitioner's level of
responsibility. (I-R)
(G)
Stroke unit registered nurses in the stroke centers shall complete the
following continuing education requirements:
1. All level I stroke unit registered nurses
shall complete a minimum of eight (8) hours of cerebrovascular disease
continuing education every year; and (I-R)
2. The stroke medical director shall review the
continuing education for appropriateness to the practitioner's level of
responsibility. (I-R)
(5) Standards for Hospital Performance
Improvement and Patient Safety, Outreach, Public Education, and Training
Programs for Stroke Center Designation.
(A)
The stroke center shall maintain an ongoing performance improvement and patient
safety program designed to objectively and systematically monitor, review, and
evaluate the quality, timeliness, and appropriateness of patient care; resolve
problems; and improve patient care. (I-R, II-R, III-R, IV-R)
1. The stroke center shall collect, document,
trend, maintain for at least five (5) years, and make available for review by
the department at least the following data elements:
A. Door-to-needle time; (I-R, II-R,
III-R)
B. Number of patients
presenting within the treatment window; and (I-R, II-R, III-R)
C. Number of eligible patients treated with
thrombolytics. (I-R, II-R, III-R)
2. The stroke center shall at least quarterly
conduct a regular morbidity and mortality review meeting which shall be
documented in the meeting minutes and/or the meeting attendance documents.
(I-R, II-R, III-R, IV-R)
3. The
stroke center shall review the reports generated by the department from the
Missouri stroke registry. (I-R, II-R, III-R, IV-R)
4. The stroke center shall conduct monthly
reviews of pre-hospital stroke care including inter-facility transfers.
(I-R, II-R, III-R, IV-R)
5. The stroke center shall participate in the
emergency medical services regional system of stroke care in its respective
emergency medical services region as defined in
19 CSR
30-40.302. (I-R, II-R, III-R, IV-R)
6. The stroke center shall document review of
its cases of stroke patients who received U.S. Food and Drug
Administration-approved thrombolytics and who remained at the referring
hospital greater than ninety (90) minutes prior to transfer. (I-R, II-R,
III-R)
7. The stroke center shall
document its review of cases of stroke patients who did not receive U.S. Food
and Drug Administration-approved thrombolytics and who remained greater than
sixty (60) minutes at the referring hospital prior to transfer. (II-R, III-R,
IV-R)
8. The stroke center shall
review and monitor the core competencies of the physicians, practitioners, and
nurses and document these core competencies have been met. (I-R, II-R, III-R,
IV-R)
(B) The stroke
center shall establish a patient and public education program to promote stroke
prevention and stroke symptoms awareness. (I-R, II-R, III-R, IV-R)
(C) It is recommended that level I, II, and
III stroke centers establish a professional education outreach program in
catchment areas to provide training and other supports to improve care of
stroke patients. (I-R, II-R, III-R)
(D) Each stroke center shall establish a
training program for professionals on caring for stroke patients in the stroke
center that includes at least the following:
1. A procedure for training nurses and
clinical staff to be credentialed in stroke care; (I-R, II-R, III-R,
IV-R)
2. A mechanism to assure that
all nurses providing care to stroke patients complete a minimum of required
continuing education as set forth in section (4) of this rule to become
credentialed in stroke care; and (I-R, II-R, III-R, IV-R)
3. The content and format of any stroke
continuing education courses developed and offered by the stroke center shall
be developed with the oversight of the stroke medical director. (I-R, II-R,
III-R, IV-R)
(E) The
stroke center shall provide and monitor timely feedback to the emergency
medical service providers and referring hospital, if involved. This feedback
shall include, at least, diagnosis, treatment, and disposition of the patients.
It is recommended that the feedback be provided within seventy-two (72) hours
of admission to the hospital. When emergency medical services does not provide
patient care data on patient arrival or in a timely fashion (recommended within
three (3) hours of patient delivery), this time frame shall not apply. (I-R,
II-R, III-R, IV-R)
(F) Stroke
centers shall be actively involved in local and regional emergency medical
services systems by providing training and clinical educational resources.
(I-R, II-R, III-R, IV-R)
(6) Standards for the Programs in Stroke
Research for Stroke Center Designation.
(A)
Level I stroke centers shall support an ongoing stroke research program as
evidenced by any of the following:
1.
Production of evidence-based reviews of the stroke program's process and
clinical outcomes; (I-R)
2.
Publications in peer-reviewed journals; (I-R)
3. Reports of findings presented at regional,
state, or national meetings; (I-R)
4. Receipt of grants for study of stroke
care; (I-R)
5. Participation in
multi-center studies; and (I-R)
6.
Epidemiological studies and individual case studies. (I-R)
(B) The stroke center shall agree to
cooperate and participate with the department in developing stroke prevention
programs. (I-R, II-R, III-R, IV-R)
*Original authority: 192.006, RSMo 1993, amended 1995;
190.185, RSMo 1973, amended 1989, 1993, 1995, 1998, 2002; and 190.241, RSMo
1987, amended 1998, 2008.