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

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

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

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

3. (c) Level III Stroke Center. A Level III Stroke Center must comply with secondary stroke recognition and prevention guidelines as required by state law. A Level III Stroke Center will 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 where symptoms have on-set within the immediately preceding 12 hours). A Level III Stroke Center must 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 3 years.A hospital must be classified at a Level III Stroke Center if it complies with (c)(1) through (c) (7) of this subsection (c):

   1. (1) Stroke Team:

      1. (A) The stroke team must be available 24 hours a day, 7 days a week;
      2. (B) The stroke team will include 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;
      3. (C) Each stroke team member must be either on-site or able to respond to the hospital within 20 minutes to the emergency department of the Stroke Center;
      4. (D) Stroke members will be trained in the care of a stroke patient, with the training updated annually;

      5. (E) The stroke team's written protocols:

         1. (i) State the standard practice for the care of stroke patients;
         2. (ii) Establish expected response time and requires the response time of stroke patients to be recorded in writing;
         3. (iii) Require the appropriate administration of an FDA-approved thrombolytic agent to occur within 60 minutes after a patient arrives at the emergency department at least 50% of the time; and
         4. (iv) Include emergency stroke care protocols as further described in (2)(D) in this subsection (c).

      6. (F) The stroke team's policies and procedures will include provisions that:

         1. (i) The stroke coordinator must be either a licensed nurse or other health professional; and
         2. (ii) All stroke team members are identified in writing.

   2. (2) Emergency Department:

      1. (A) The emergency department will include a licensed independent practitioner able to:

         1. (i) Recognize, assess and if indicated administer thrombolytic therapy to stroke patients; and
         2. (ii) Assess potential stroke patients within 15 minutes of arrival.
      2. (B) The emergency department will include nursing personnel trained in emergent stroke care that are available on-site 24 hours a day. Training must occur at least every 2 years through evidence of competency;

      3. (C) The emergency department must have written comprehensive stroke protocols for the treatment and stabilization of a stroke patientThese protocols include:

         1. (i) Detailed instructions on IV thrombolytic use;
         2. (ii) Reversal of anticoagulation in patients with hemorrhagic stroke;
         3. (iii) A standardized stroke assessment scale;
         4. (iv) Protocols for the control of seizures;
         5. (v) Blood pressure management; and
         6. (vi) Care for patients, who have suffered a stroke, but are not eligible to receive thrombolytic agents.
      4. (D) The emergency department collaborates 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. (3) Supplies and equipment:

      1. (A) All equipment and supplies will meet the requirements of OAC 310:667-59-9 (a)(3);

      2. (B) The following must be available on-site24 hours a day:

         1. (i) thrombolytic agents, which are FDA approved for the treatment of acute non-hemorrhagic stroke;
         2. (ii) seizure control agents; and
         3. (iii) thiamine and glucose for intravenous administration.

   4. (4) Neuroimaging services:

      1. (A) Diagnostic x-ray and computerized tomography (CT) services must be on site and available 24 hours a day;
      2. (B) Radiologic technologist and CT technologist must be on duty or on call with a 20 minute response time, 24 hours a day, seven (7) 7 days a week. A single technologist designated as qualified by the radiologist in both diagnostic x-ray and CT procedures may be used to meet this requirement if an on-call schedule of additional diagnostic imaging personnel is maintained;
   5. (5) Laboratory services:

   Laboratory services must be on-site and available 24 hours a day, 7 days a week. These services include:

   1. (A) A complete blood count;
   2. (B) Metabolic profile;
   3. (C) Coagulation studies (prothrombin time, international normalized ratio);
   4. (D) Pregnancy testing; and
   5. (E) Troponin I.

   6. (6) Outcome and quality improvement:

      1. (A) The hospital will track the number of all 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;
      2. (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;
      3. (C) There will be a policy for and review of all patients who received thrombolytics more than 60 minutes after hospital presentation;
      4. (D) If a hospital 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;

      5. (E) Provide no less than quarterly feedback to:

         1. (i) Hospital physicians and other health professionals;
         2. (ii) Emergency medical service agencies; and
         3. (iii) Referring hospitals;
      6. (F) There will be a review of all acute stroke patients who require more than 2 hours to be transferred (arrival-to-departure time);
      7. (G) The time from ordering to interpretation of a head CT or MRI will be tracked; and
      8. (H) Door-to-computer link time for cases where a tele-technology is used;
      9. (I) The hospital will make available to the Department any information referenced in this paragraph upon request.

   7. (7) Agreements and policies:

      1. (A) The Level III stroke center must have 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:

         1. (i) May be retained for treatment in-house;
         2. (ii) Require stabilizing treatment; and
         3. (iii) Require transfer to another facility.
      2. (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.

4. (d) Level IV Stroke Referral Center. A Level IV Stroke referral center must comply with secondary stroke recognition and prevention guidelines as required by state law and mustbe a referral center lacking sufficient resources to provide definitive care for stroke patients. A Level IV Stroke referral Center will provide prompt assessment, indicated resuscitation and appropriate emergency intervention. The Level IV Stroke referral Center will arrange and expedite transfer to a higher level stroke center as appropriate. A hospital must receive a Level IV Stroke referral Center designation by the Department, with renewal occurring in 3 year intervals, provided the hospital is not certified as a level I, II or III stroke center if it complies with all of this subsection (d):

   1. (1) Emergency Department:

      1. (A) 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;
      2. (B) Enter into transfer agreements for expeditious transfer of acute stroke patients to stroke centers able to provide a higher level of care;
      3. (C) 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 less than 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;
      4. (D) A health care professional that is able to recognize and assess stroke patients within 15 minutes of arrival; and
      5. (E) 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. (2) Supplies and equipment: All Level IV Stroke referral Centers must meet the requirements of OAC 310:667-59-9(a)(3).
   3. (3) Laboratory services: No requirements.

   4. (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:

      1. (A) A hospital will meet the applicable outcome and quality measures listed in (c)(6) in this Section; and
      2. (B) Track and review all acute stroke transfer cases requiring longer than an arrival-to-departure time of less than 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. (5) Agreements and policies:

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

         1. (i) Which patients may be retained or referred for palliative or end-of-life care;
         2. (ii) Which patients shall require stabilizing treatment; and
         3. (iii) Which patients shall require transfer to a Level I, II or III Stroke Center;
      2. (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.

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.

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

Amended at 39 Ok Reg 1392, eff 9-11-22