Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 40 - Comprehensive Emergency Medical Services Systems Regulations › Section 19 CSR 30-40.730 - Standards for Stroke Center Designation

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This amendment changes continuing education
				  hours to be consistent with required continuing education requirements by
				  national designating or verifying bodies of stroke centers, removes continuing
				  medical education requirements for physicians who are emergency medicine board
				  certified or board eligible through the American Board of Emergency Medicine or
				  the American Osteopathic Board of Emergency Medicine and who are practicing in
				  the emergency department of a stroke center, removes requirements relating to
				  the operation or construction of a helipad at stroke centers, and adds an
				  option for stroke centers to enter stroke data into an national data registry
				  or databank that will allow the stroke center to perform its performance
				  improvement and patient safety program requirements.
(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)