Current through Register Vol. 46, No. 39, September 25, 2024
(a)
Definitions.
The following terms when used in this section shall have
the following meanings:
(1)
Stroke patient means a patient exhibiting the signs and
symptoms of a suspected stroke.
(2)
Certifying organization means an accrediting organization
approved by The Centers for Medicare and Medicaid Services (CMS), that has
applied to the department and has been approved by the department to certify
that a hospital meets the criteria to provide advanced stroke care.
(3)
Certified stroke center
means a general hospital that has successfully completed a stroke center
certification with a certifying organization.
(4)
Designated stroke center
means a certified stroke center approved by the department to operate as a
designated stroke center under this section.
(b)
General provisions.
(1) General hospitals may choose to
participate in the designated stroke center program under this
section.
(2) Only a certified
stroke center may apply for stroke center designation from the
department.
(3) No hospital shall
hold itself out to the public as having a stroke center designation unless it
has a stroke center designation under this section.
(c)
Certifying organization
application.
Accrediting organizations may apply, in a format
determined by the department, to be approved as certifying organizations. Upon
review of the application, the department may approve certifying organizations
to perform stroke center certification.
(d)
Stroke center designation.
Hospitals seeking stroke center designation shall:
(1) Obtain and maintain continuous stroke
center certification from a certifying organization. The department may
participate in any onsite visits conducted by the certifying organization
during certification and recertification.
(2) Submit an application to the department
with a copy of the certifying organization's certification and supporting
documents. When determining whether to approve a certified stroke center as a
designated stroke center, the department may take other criteria into
consideration, including but not limited to investigations by Federal or State
oversight agencies.
(e)
Issuing authority.
The department shall make the final determination on all
applications for stroke center designation. The department shall provide
written notification to a hospital when an application for a stroke center
designation is approved. If an application for stroke center designation is
denied, the department shall provide written notification and a rationale for
the denial, and shall allow additional opportunities for the hospital to apply
for a stroke center designation.
(f)
Withdrawal of stroke center
designation.
(1) The department may
withdraw a hospital's stroke center designation upon notice to a designated
stroke center if:
(i) the designated stroke
center does not comply with State or Federal regulations relating to stroke
centers;
(ii) the designated stroke
center fails to comply with its certifying organization's certification
requirements and certification lapses;
(iii) the designated stroke center requests
withdrawal of stroke center designation.
(2) Before withdrawing a stroke center
designation pursuant to subparagraph (1)(i) or (ii) of this subdivision, the
department shall provide the designated stroke center with a written notice
containing a statement of deficiencies. If the designated stroke center fails
to adopt a plan of correction acceptable to the department within 30 days, the
department may withdraw the hospital's stroke center designation.
(3) If a hospital no longer maintains stroke
center designation, the hospital shall immediately notify affected parties and
provide the department with a written plan describing specific measures it has
taken to alter its arrangements and protocols under subdivision (i) of this
section within 30 days of a withdrawal of stroke center designation.
(g)
Transition
period.
(1) Hospitals designated as
stroke centers by the Department prior to the effective date of this section
shall have two years from the effective date of this section to initiate the
stroke center certification process with a certifying organization approved by
the Department. The process is initiated when a hospital enters into a
contractual agreement with a certifying organization. Once the hospital has
entered into a contractual agreement with a certifying organization, the
hospital shall have one year to complete the certification process.
(2) Any hospital that does not initiate the
stroke center certification process with a certifying organization within two
years of the effective date of this section shall no longer maintain a stroke
center designation and may no longer hold themselves out as a designated stroke
center.
(3) The Department may
extend the transition period specified in paragraphs (1) and (2) of this
subdivision as deemed necessary. The Department will notify all impacted
hospitals of any decision to extend the transition period.
(h)
Coordination agreement.
Designated stroke centers shall communicate and
coordinate with one another to ensure appropriate access to care for stroke
patients, in accordance with a written coordination agreement. The department
may issue guidance to specify the provisions of coordination agreements.
Designated stroke centers shall have policies and procedures in place for
timely transfer and receipt of stroke patients to and from other hospitals
consistent with section
405.19 of this Part. Transport of
stroke patients to the appropriate receiving hospital shall be in accordance
with State Emergency Medical Advisory Committee (SEMAC) approved EMS protocols
developed and adopted pursuant to subdivision two of section
3002-a of
the Public Health Law.
(i)
Emergency medical services providers; assessment and transportation of
stroke patients to designated stroke centers.
Designated stroke centers shall work with emergency
medical services agencies to ensure that stroke center destination protocols
are consistent with protocols adopted by the State Emergency Medical Advisory
Committee, the State Emergency Medical Services Council (SEMSCO), the Regional
Emergency Medical Advisory Committee (REMAC), and the Regional Emergency
Medical Services Council (REMSCO).
(j) The department shall maintain and post on
its public web page a list of designated stroke centers. The department shall
notify the State EMS advisory bodies and EMS regions via established
communication networks whenever there is a change to a hospital stroke center
designation, including but not limited to a new designation or a withdrawal of
designation.
(k)
Reporting of
data and quality of care initiatives.
(1) Each designated stroke center shall
submit data, as requested by the department, that shall be sufficient to
determine the performance of the hospital and the system of care on at least an
annual basis and in a format determined by the department.
(2) The department shall define the data
elements to be reported.
(3) Each
designated stroke center shall conduct stroke quality improvement activities
including, but not limited to:
(i) evaluation
of the quality and appropriateness of care provided;
(ii) participation in regional and statewide
quality improvement activities, including but not limited to activities
conducted by the Regional Emergency Medical Advisory Committee, consistent with
section
3006 of the
Public Health Law;
(iii) analysis
of data to identify opportunities for improvement; and
(iv) integration of these activities with the
hospital's quality assurance program, as required by section
405.6 of this Part.
