Title: Section 405.34 Stroke services

Section 405.34 Stroke services.

(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 subdivision (f)(1)(i) or (ii) of this section, 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 thirty (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 thirty (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.