SECTION 310:667-59-20. Classification of emergency stroke services

(a)   Level I Stroke Center. A Level I Stroke Center shall be deemed to adhere to primary and secondary stroke recognition and prevention guidelines as required by state law and serve as a resource center for other hospitals in the region and be a comprehensive receiving facility staffed and equipped to provide total care for all major needs of the stroke patient as determined by:

(1)   An up-to-date certification as a Comprehensive Stroke Center from a Centers for Medicare and Medicaid Services deemed accrediting agency or a Department approved organization that uses a nationally recognized set of guidelines; and

(2)   Providing quality assurance information, including benchmark tracking and other data to the department upon request.

(b)   Level II Stroke Center. A Level II Stroke Center shall be deemed to adhere to primary and secondary stroke recognition and prevention guidelines as required by state law and be a receiving center staffed by in-patient stroke services staff and be equipped to provide definitive care for a major proportion of stroke patients within the region as determined by:

(1)   An up-to-date certification as a Primary Stroke Center from a Centers for Medicare and Medicaid Services deemed accrediting agency or a Department approved organization that uses a nationally recognized set of guidelines; and

(2)   Providing quality assurance information, including benchmark tracking and other data to the department upon request.

(c)   Level III Stroke Center. A Level III Stroke Center shall be deemed to adhere to secondary stroke recognition and prevention guidelines as required by state law and be staffed and equipped to provide initial diagnostic services, stabilization, thrombolytic therapy, emergency care to patients who have suffered an acute stroke (which is a stroke wherein symptoms have on-set within the immediately preceding twelve (12) hours). They shall have an up-to-date certification as an Acute Stroke Ready Hospital from a Centers for Medicare and Medicaid Services deemed accrediting agency or from a department approved organization that uses a nationally recognized set of guidelines or from the department for a period not to exceed three years and meet the following requirements:

(1)   Stroke Team:

(A)   Having a stroke team available twenty-four (24) hours a day, seven (7) days a week;

(B)   Having a licensed physician trained in the care of the emergent stroke patient and credentialed by the hospital to provide emergency medical service for stroke patients, including the ability to administer thrombolytic agents;

(C)   Having designated stroke team(s) that are identified in writing, which is either on-site or each member is able to respond to the hospital within twenty (20) minutes to the emergency department of the Stroke Center;

(D)   Having members trained in the care of a stroke patient, with said training updated annually;

(E)   Having response times of the stroke team established and tracked in writing;

(F)   Adoption of standard practice protocols for the care of a stoke patient in writing, which shall include the appropriate administration of an FDA-approved thrombolytic agent within sixty (60) minutes following the arrival of a patient who has suffered a stroke at the emergency department at least fifty percent (50%) of the time;

(G)   Written emergency stroke care protocols adopted; and

(H)   A licensed nurse or other health professional designated as the stroke coordinator.

(2)   Emergency Department:

(A)   A licensed independent practitioner able to recognize, assess and if indicated administer thrombolytic therapy to stroke patients;

(B)   A licensed independent practitioner will assess potential stroke patients within 15 minutes of arrival;

(C)   Having nursing personnel available on-site twenty-four (24) hours a day, seven (7) days a week who are trained in emergent stroke care, which is demonstrated at least every two (2) years through evidence of competency;

(D)   For a hospital, licensed as a general medical surgical hospital or a specialty hospital, all emergency services shall meet the requirements of Oklahoma Administrative Code (OAC) 310:667-29-1 and 310:667-29-2;

(E)   For a hospital, licensed as critical access hospital, all emergency services shall meet the requirements of OAC 310:667-39-14;

(F)   Adopt written comprehensive stroke protocols for the treatment and stabilization of a stroke patient, which shall include, but not be limited to:

(i)   Detailed instructions on IV thrombolytic use;

(ii)   Reversal of anticoagulation in patients with hemorrhagic stroke;

(iii)   A standardized stroke assessment scale;

(iv)   Protocols for the control of seizures;

(v)   Blood pressure management; and

(vi)   Care for patients, who have suffered a stroke, but are not eligible to receive thrombolytic agents.

(G)   Collaborate with emergency medical service agencies to develop inter-facility transfer protocols for stroke patients and will only use those emergency medical service agencies that have a Department approved protocol for the inter-facility transfer of stroke patients.

(3)   Supplies and equipment:

(A)   All equipment and supplies shall meet the requirements of OAC 310:667-59-9 (a);

(B)   Have available on-site, twenty-four (24) hours a day, seven (7) days a week, thrombolytic agents, which are FDA approved for the treatment of acute non-hemorrhagic stroke;

(C)   Have available on-site, twenty-four (24) hours a day, seven (7) days a week, seizure control agents; and

(D)   Have available on-site, twenty-four (24) hours a day, seven (7) days a week, thiamine and glucose for intravenous administration.

(4)   Neuroimaging services:

(A)   Have available on-site, twenty-four (24) hours a day, seven (7) days a week diagnostic x-ray and computerized tomography (CT) services;

(B)   Have on duty or on call with a twenty (20) minute response time, twenty-four (24) hours a day, seven (7) days a week radiologic technologist and CT technologist. A single technologist designated as qualified in both diagnostic x-ray and CT procedures by the radiologist may be used to meet this requirement if an on-call schedule of additional diagnostic imaging personnel is maintained;

(C)   For a hospital licensed as a general medical surgical hospital or specialty hospital, diagnostic imaging services shall also comply with the applicable requirements in OAC 310:667-23 of this Chapter; and

(D)   For a hospital licensed as a critical access hospital, diagnostic imaging services shall also comply with the applicable requirements in OAC 310:667-39.

(5)   Laboratory services:

(A)   Laboratory services shall be provided on-site and available twenty-four (24) hours a day, seven (7) days a week, and at a minimum provide the following:

(i)   A complete blood count;

(ii)   Metabolic profile;

(iii)   Coagulation studies (prothrombin time, international normalized ratio);

(iv)   Pregnancy testing; and

(v)   Troponin I.

(B)   For a hospital licensed as a general medical surgical hospital or specialty hospital, clinical laboratory services shall also comply with the applicable requirements in OAC 310:667-23; and

(C)   For a hospital licensed as a critical access hospital, clinical laboratory services shall also comply with the applicable requirements in OAC 301:667-39.

(6)   Outcome and quality improvement: Outcome and quality improvement activities shall include the tracking of all stroke patients, appropriate use of thrombolytic therapy, performance measures and at a minimum the following steps shall be accomplished, which shall be verifiable and made available upon request by the Department:

(A)   The facility will track the number of stroke and acute stroke patients, the number treated with thrombolytic therapy, including how soon after hospital presentation (arrival to needle time), the number of acute stroke patients not treated and indications for why they were not treated;

(B)   There will be an official policy to review the care of all acute stroke patients that were eligible for thrombolytics and did not receive them;

(C)   There will be a policy for and review of all patients who received thrombolytics more than 60 minutes after hospital presentation;

(D)   If a facility fails to provide thrombolytics within 60 minutes to at least 50% of eligible patients for two consecutive quarters, they will develop and implement an internal plan of corrections;

(E)   Provide no less than quarterly feedback to:

(i)   Hospital physicians and other health professionals;

(ii)   Emergency medical service agencies; and

(iii)   Referring hospitals;

(F)   There will be a review of all acute stroke patients who require more than 2 hours to be transferred (arrival-to-departure time);

(G)   The time from ordering to interpretation of a head CT or MRI will be tracked; and

(H)   Door-to-computer link time for cases where a tele-technology is used.

(7)   Agreements and policies:

(A)   The stroke center shall develop and implement a written plan for transfer of patients to a Level I or Level II stroke facility as appropriate, defining medical conditions and circumstances for those emergency patients who:

(i)   May be retained for treatment in-house;

(ii)   Require stabilizing treatment; and

(iii)   Require transfer to another facility.

(B)   If a stroke telemedicine program is utilized, there will be a written, contractual agreement addressing, at a minimum, performance standards, legal issues and reimbursement.

(d)   Level IV Stroke Referral Center. A Level IV Stroke referral center shall be deemed to adhere to secondary stroke recognition and prevention guidelines as required by state law and is a referral center lacking sufficient resources to provide definitive care for stroke patients. A Level IV Stroke referral Center shall provide prompt assessment, indicated resuscitation and appropriate emergency intervention. The Level IV Stroke referral Center shall arrange and expedite transfer to a higher level stroke center as appropriate. A hospital shall receive a Level IV Stroke referral Center designation by the Department, which shall be renewed in three (3) year intervals, providing the hospital is not certified as a level I, II or III stroke center and meets the following requirements:

(1)   Emergency Department:

(A)   For a hospital licensed as a general medical surgical hospital or specialty hospital, emergency services shall comply with the requirements of OAC 310:667-29-1 and OAC 310:667-29-2;

(B)   For a hospital licensed as a critical access hospital, emergency services shall comply with OAC 310:667-39-14;

(C)   For acute stroke patients requiring transfer by emergency medical services, said services will be contacted and emergently requested no more than 20 minutes after patient arrival;

(D)   Enter into transfer agreements for expeditious transfer of acute stroke patients to stroke centers able to provide a higher level of care;

(E)   Have a comprehensive plan for the prompt transfer of acute stroke patients to higher level stroke centers which includes an expected arrival-to-departure time of < 60 minutes, with the ability to provide documentation demonstrating the ability to meet this requirement at least 65% of the time on a quarterly basis;

(F)   A health care professional able to recognize stroke patients will assess the patient within 15 minutes of arrival; and

(G)   Collaborate with emergency medical service agencies to develop inter-facility transfer protocols for stroke patients and will only use those emergency medical service agencies that have a Department approved protocol for the inter-facility transfer of stroke patients.

(2)   Supplies and equipment: All Level IV Stroke referral Centers shall meet the requirements of OAC 310:667-59-9(a)(3).

(3)   Laboratory services:

(A)   For a hospital licensed as a general medical surgical hospital or specialty hospital, clinical laboratory services shall also comply with the applicable requirements in OAC 310:667-23; and

(B)   For a hospital licensed as a critical access hospital, clinical laboratory services shall also comply with the applicable requirements in OAC 310:667-39.

(4)   Outcome and quality improvement: The following outcome and quality improvement requirements are applicable to Level IV Stroke referral Centers, which include tracking of all patients seen with acute stroke:

(A)   A facility will meet the applicable outcome and quality measures listed in section 310:667-59-20(G)  ¹  ; and

(B)   Track and review all acute stroke transfer cases requiring longer than an arrival-to-departure time of > 60 minutes. If over two consecutive quarters inter-facility transfers (arrival-to-departure) exceeds > 60 minutes more than 35% of the time the facility will create and implement an internal plan of correction.

(5)   Agreements and policies:

(A)   A Level IV Stroke referral Center shall develop and implement a written plan for transfer of patients to a Level I, II or III Stroke Center. The written plan shall establish medical conditions and circumstances to determine:

(i)   Which patients may be retained or referred for palliative or end-of-life care;

(ii)   Which patients shall require stabilizing treatment; and

(iii)   Which patients shall require transfer to a Level I, II or III Stroke Center;

(B)   Development and implementation of policy and transfer agreements directing transfer of acute stroke patients to the closest appropriate higher level facility. Patient preference may be taken into consideration when making this decision.

[Source: Reserved at 17 Ok Reg 2992, eff 7-13-00; Added at 25 Ok Reg 2785, eff 7-17-08 (emergency); Added at 26 Ok Reg 2054, eff 6-25-09; Amended at 27 Ok Reg 2542, eff 7-25-10; Amended at 32 Ok Reg 1790, eff 9-11-15]

Note

AGENCY NOTE: In the process of drafting and revising new language for this section 310:667-59-20, a change in numbering was not captured in the new rule text in subparagraph (d)(4)(A) of this section. The cross-reference to 310:667-59-20(G) in this subparagraph is invalid and refers to a non-existent subsection. The cross-reference should refer to 310:667-59-20(c)(6), relating to outcome and quality improvement measures. This error will be revised in future rule-making.