1. (a) Level IV. A Level IV hospital will provide emergency pediatric medicine and trauma services with at least a licensed independent practitioner, registered nurse, licensed practical nurse, or an Intermediate, Advanced Emergency Medical Technician (AEMT) or paramedic, as defined in OAC 310:641-1-7, on site 24 hours a day. The hospital will be capable of identifying critically ill or injured pediatric patients and providing stabilizing treatment to manage airway, breathing, and circulation prior to patient transfer. A hospital must be classified at Level IV for emergency pediatric medicine and trauma services if it complies with all of this subsection (a):

   1. (1) Clinical services and resources. Diagnostic, surgical, or medical specialty services are not required. The hospital must have access by telephone or other electronic means to a regional poison control center.
   2. (2) Personnel. A physician, licensed independent practitioner, registered nurse, licensed practical nurse, or an AEMT or paramedic, as defined in OAC 310:641-1-7, is required on site 24 hours a day. In the absence of a physician, licensed independent practitioner, registered nurse, or paramedic at least one of the practitioners on duty must have received training in advanced life support techniques and must be competent to initiate treatment of the emergency patient.

   3. (3) Supplies and equipment. The hospital must have equipment for use in the resuscitation of pediatric patients on site, functional, and immediately available, including the following:

      1. (A) Spine board (child/adult) for cardiopulmonary resuscitation and papoose board for immobilization of infants and toddlers;
      2. (B) Airway control and ventilation equipment, including laryngoscopes and endotracheal tubes of all sizes, bag-mask resuscitator, pocket masks, oxygen, and oxygen delivery equipment. Masks and cannula shall be available in infant, child, and adult sizes;
      3. (C) Pulse oximeter with adult and pediatric probes;
      4. (D) Infant, child, adult, and thigh blood pressure cuffs;
      5. (E) Rectal thermometer probe;
      6. (F) Suction devices suitable for infants, children, and adults;
      7. (G) Electrocardiograph-oscilloscope-defibrillator-pacer with pediatric capability;
      8. (H)

   Equipment for gastric decompression;

   1. (I) Magill forceps (pediatric and adult);
   2. (J) Equipment for gastric decompression;

   3. (K) Fracture management devices including:

      1. (i) Skeletal traction devices including cervical immobilization device suitable for pediatric patients;
      2. (ii) Extremity splints; and
      3. (iii) Child and adult femur splints.
   4. (L) Drugs necessary for pediatric emergency care with printed pediatric doses and pediatric reference materials such as precalculated drug sheets or length-based tape;
   5. (M) Infant scale;
   6. (N) Thermal control equipment for patients including a heat source or procedure for infant warming;
   7. (O) Two-way communication with vehicles of emergency transport system as required at OAC 310:667-29-1(c)(4);
   8. (P) Standard intravenous fluids and administration devices suitable for infants, children, and adults including large-bore intravenous catheters; and

   9. (Q) Specialized pediatric procedure trays for:

      1. (i) Lumbar puncture;
      2. (ii) Urinary catheterization;
      3. (iii) Umbilical vessel cannulation; and
      4. (iv) Airway control/cricothyrotomy;
      5. (v) Vascular access; and
      6. (vi) Chest decompression.

   10. (4) Agreements and policies on transfers.

       1. (A) The hospital must have written policies defining the medical conditions and circumstances for emergency patients that may be retained for treatment in-house, and for those requiring stabilizing treatment and transfer to another hospital.
       2. (B) The hospital must have transfer agreements with a hospital capable of providing burn care in a physician-directed, organized burn care center with a staff of nursing personnel trained in burn care and equipped properly for care of the extensively burned patient.
       3. (C) The hospital must have transfer agreements with a hospital capable of providing acute spinal cord and head injury management and rehabilitation.
       4. (D) The hospital must have transfer agreements with a hospital capable of providing rehabilitation services in a rehabilitation center with a staff of personnel trained in rehabilitation care and equipped properly for acute care of the critically injured patient.

   11. (5) Quality Improvement. In addition to any other quality improvement requirements governing the hospital, the quality improvement program must also include the following subjects:

       1. (A) Trauma registry;
       2. (B) Audit for all pediatric deaths to include prehospital care and care received at a transferring facility;
       3. (C) Incident reports related to pediatric patients;
       4. (D) Pediatric transfers;
       5. (E) Child abuse cases;
       6. (F) Pediatric cardiopulmonary or respiratory arrests;
       7. (G) Pediatric admissions within 48 hours of an emergency department visit;
       8. (H) Pediatric surgery within 48 hours of discharge from an emergency department;
       9. (I) Morbidity and mortality review;
       10. (J) Medical nursing audit, utilization review, tissue review; and
       11. (K) The availability and response times of on call staff specialists must be defined in writing, documented, and continuously monitored.

2. (b) Level III. A Level III hospital will provide emergency pediatric medicine and trauma services with an organized trauma service and emergency department. A physician and nursing staff with special capability in trauma care arerequired on site 24 hours a day. General surgery and anesthesiology services will be available either on duty or on call. The hospital will have basic facilities for the management of minor pediatric inpatient problems. A hospital must be classified at Level III for emergency pediatric medicine and trauma services if it complies with all of this subsection (b):

   1. (1) Clinical services and resources.

      1. (A) Trauma service. A trauma service will be established by the medical staff and itwill be responsible for coordinating the care of injured patients, the training of personnel, and trauma quality improvement.

         1. (i) Privileges for physicians participating in the trauma service will be determined by the medical staff credentialing process.
         2. (ii) All patients with multiple-system or major injury will be evaluated by the trauma service.
         3. (iii) The surgeon responsible for the overall care of the admitted patient will be identified.
      2. (B) Emergency services. A physician competent in the care of the seriously ill or injured patient and credentialed by the hospital to provide emergency medical services and nursing personnel with special capability in trauma care must be on site 24 hours a day. The emergency service may also serve as the trauma service.
      3. (C) Poison control center. The hospital must have access by telephone or other electronic means to a regional poison control center.
      4. (D) General surgery. A board certified, board eligible, or residency trained general surgeon must be on call 24 hours a day and promptly available in the emergency department.
      5. (E) Anesthesia. Anesthesia services must be on call 24 hours a day, promptly available, and administered in accordance with OAC 310:667-25-2.
      6. (F) Internal medicine. A physician board certified, board eligible, or residency trained in internal medicine must be on call 24 hours a day and promptly available in the emergency department.
      7. (G) Operating suite. An operating suite with thermal control equipment for patients and infusion of blood and fluids must be available 24 hours a day.
      8. (H) Post-anesthesia recovery unit. The hospital must have a post-anesthesia recovery room or intensive care unit that is in compliance with OAC 310:667-15-7 with nursing personnel and anesthesia services remaining in the unit until the patient is discharged from post-anesthesia care.

      9. (I) Intensive care unit. The hospital's intensive care unit must include:

         1. (i) Compliance with OAC 310:667-15-7;
         2. (ii) A registered nurse on duty in the intensive care unit when it has a patient;
         3. (iii) A registered nurse on call and immediately available when the unitdoes not have a patient; and
         4. (iv) Written policies defining the minimum staffing requirements for the intensive care unit that must bemonitored through the quality improvement program.
      10. (J) Diagnostic imaging. The hospital will have diagnostic x-ray services available 24 hours a day. A radiology technologist will be on duty or on call and immediately available 24 hours a day.

      11. (K) Clinical laboratory service. The hospital must have clinical laboratory services available 24 hours a day. All or part of these services may be provided by arrangements with certified reference laboratories that are available on an emergency basis 24 hours a day. These services include:

          1. (i) Comprehensive immunohematology services including blood typing and compatibility testing;
          2. (ii) A supply of blood and blood products on hand that is properly stored and adequate to meet expected patient needs;
          3. (iii) Access to services provided by a community central blood bank;
          4. (iv) Standard analysis of blood, urine, and other body fluids to include routine chemistry and hematology testing;
          5. (v) Therapeutic drug monitoring;
          6. (vi) Coagulation studies;
          7. (vii) Blood gas/pH analysis;
          8. (viii) Comprehensive microbiology services or at least appropriate supplies for the collection, preservation, and transport of clinical specimens for aerobic and anaerobic bacterial, mycobacterial, and fungus cultures; and
          9. (ix) Drug and alcohol screening.
      12. (L) Social services. Social services must be available and provided as required in Subchapter 31 of this Chapter.

      13. (M) Burn Care.

          1. (i) The hospital must provide burn care in a physician-directed, organized burn care center with a staff of nursing personnel trained in burn care and equipped properly for care of the extensively burned patient; or
          2. (ii) If it is unable to satisfy (i) of this subparagraph, then it must have a written transfer agreement with a hospital that satisfies (i) of this subparagraph.
      14. (N) Spinal cord and head injury management. The hospital must provide acute spinal cord and head injury management and must have a written transfer agreement with a hospital that provides comprehensive rehabilitation services. If it is unable to satisfy this requirement it must have a transfer agreement with a hospital capable of providing acute spinal cord and head injury management and rehabilitation.

      15. (O) Rehabilitation services.

          1. (i) The hospital must provide rehabilitation services in a rehabilitation center with a staff of personnel trained in rehabilitation care and equipped properly for acute care of the critically injured patient; or
          2. (ii) If it is unable to satisfy (i) of this subparagraph, then it must have a written transfer agreement with a hospital that satisfies (i) of this subparagraph and the requirements of Subchapter 35 of this Chapter.
      16. (P) Respiratory therapy. Routine respiratory therapy procedures and mechanical ventilators must be available 24 hours a day, and the respiratory therapy services must bein compliance with OAC 310:667-23-6.

   2. (2) Personnel.

      1. (A) Trauma service director. The medical staff will designate a surgeon as trauma service director.The trauma service director's responsibilities include:

         1. (i) All trauma patients and administrative authority for the hospital's trauma program, through the quality improvement process; and
         2. (ii) Appointments and removals from the trauma service.
      2. (B) Emergency services director. The medical staff will designate a physician credentialed to provide emergency medical care as emergency services director.
      3. (C) Surgical director. The medical staff will designate a surgeon credentialed by the hospital to be the director of care for surgical and critical care for trauma patients.
      4. (D) Pediatrics. A physician board certified, board eligible, or residency trained in pediatrics and competent in the care of pediatric emergencies must be available for consultation on site or immediately available by telephone or other electronic means 24 hours a day.
      5. (E) Orthopedics. A physician board certified, board eligible, or residency trained in orthopedics and competent in the care of pediatric orthopedic emergencies must be available for consultation on site or immediately available by telephone or other electronic means 24 hours a day.

   3. (3) Supplies and equipment.

      1. (A) Emergency department. The hospital must have equipment for use in the resuscitation of pediatric patients on site, functional, and immediately available, including:

         1. (i) The supplies and equipment listed in (a)(3)(A) through (O) of this Section for Level IV classification;
         2. (ii) Standard intravenous fluids and administration devices suitable for infants, children, and adults including infusion pumps with microinfusion capability and large-bore intravenous catheters;

         3. (iii) Specialized pediatric procedure trays:

            1. (I) Lumbar puncture;
            2. (II) Urinary catheterization;
            3. (III) Umbilical vessel cannulation;
            4. (IV) Airway control/cricothyrotomy;
            5. (V) Thoracotomy;
            6. (VI) Chest decompression.
            7. (VII) Intraosseous infusion;
            8. (VIII) Vascular access; and
            9. (IX) Needle cricothyroidotomy set; and
         4. (iv) Slit lamp.
   4. (4) Policies on transfers. The hospital must have written policiesfor transfer to anotherhospital.[See (a)(4)(A) in this Section (relating to agreement and policies on transfers)].

   5. (5) Quality Improvement. In addition to any other quality improvement requirements governing the hospital, quality improvement programs must include the following subjects:

      1. (A) All of the quality improvement subjects listed for Level III classification as set forth in (a)(5) of this Section;
      2. (B)

   Published on call schedules for surgeons, neurosurgeons, and orthopedic surgeons; and

   1. (C) Review of the times and reasons for trauma-related bypass.

3. (c) Level II. A Level II hospital will provide emergency pediatric medicine and trauma services with organized emergency and pediatrics departments and an organized pediatric trauma service with a designated general or pediatric surgeon as director. A physician and nursing staff with special capability in pediatric emergency and trauma care will be on site 24 hours a day. General surgery and anesthesiology services will be available on site or on call 24 hours a day. Services from additional clinical specialties including pediatrics, neurosurgery, orthopedics, and critical care must be promptly available on call. A hospital must be classified at Level II for emergency pediatric medicine and trauma services if it complies with all of this subsection:

   1. (1) Clinical services and resources.

      1. (A) Pediatric trauma service. A pediatric trauma service will be established by the medical staff and will be responsible for coordinating the care of injured pediatric patients, the training of personnel, and trauma quality improvement.

         1. (i) Privileges for physicians participating in the pediatric trauma service will be determined by the medical staff credentialing process.
         2. (ii) All pediatric patients with multiple-system or major injury shall be evaluated by the trauma service.
         3. (iii) The surgeon responsible for the overall care of the admitted patient must be identified.
      2. (B) Emergency services. A physician competent in the care of the seriously ill or injured pediatric patient and credentialed by the hospital to provide pediatric emergency medical services and nursing personnel with special capability in pediatric emergency and trauma care must be on site 24 hours a day.
      3. (C) Poison control center. The hospital must have access by telephone or other electronic means to a regional poison control center.
      4. (D) Pediatric services. The hospital must have an organized pediatric service with appropriately credentialed physicians experienced in the care of seriously ill or injured pediatric patients immediately available 24 hours a day. Physicians must be board certified, board eligible, or residency trained in pediatrics. On call physicians will respond as required by the hospital's policy.
      5. (E) General surgery. A general surgeon or senior surgical resident competent and appropriately credentialed by the hospital must be on site or on call 24 hours a day and promptly available in the emergency department.
      6. (F) Anesthesia. A board certified, board eligible, or residency trained anesthesiologist must be on site or on call 24 hours a day and promptly available in the emergency department. If the anesthesiologist is not present in the hospital before the physician's arrival, anesthesia services may be provided by a certified registered nurse anesthetist (CRNA). The CRNA will be considered competent in the assessment of emergent situations in trauma patients and of initiating and providing any indicated treatment. All anesthesia must be administered in accordance with OAC 310:667-25-2.
      7. (G) Neurologic surgery. A board certified, board eligible, or residency trained neurosurgeon or other physician competent in the care of pediatric patients with neurotrauma and appropriately credentialed must be on site or on call 24 hours a day and promptly available in the emergency department. If care is initiated by a physician other than a neurosurgeon, the neurosurgeon on call will respond as required by the hospital's policy.
      8. (H) Orthopedics. A physician board certified, board eligible, or residency trained in orthopedics and competent in the care of pediatric orthopedic emergencies will be on site or on call twenty-four (24) hours a day and promptly available in the emergency department.

      9. (I) Other specialties. The hospital must also have the following specialty services on call and promptly available:

         1. (i) Cardiac surgery;
         2. (ii) Cardiology;
         3. (iii) Neurology;
         4. (iv) Obstetric/gynecologic surgery;
         5. (v) Ophthalmic surgery;
         6. (vi) Oral/maxillofacial surgery;
         7. (vii) Orthopedic surgery;
         8. (viii) Otolaryngology;
         9. (ix) Plastic surgery;
         10. (x) Pulmonary medicine;
         11. (xi) Radiology;
         12. (xii) Thoracic surgery; and
         13. (xiii) Urology and urologic surgery.
      10. (J) Operating suite. An operating suite with adequate staff and equipment must be immediately available 24 hours a day. The hospital will define and document in writing the minimum staffing requirements for the operating suite. An on call schedule for emergency replacement staff will be maintained.
      11. (K) Post-anesthesia recovery unit. The hospital will have a post-anesthesia recovery room or intensive care unit that is in compliance with OAC 310:667-15-7 and nursing personnel and anesthesia services will remain in the unit until the patient is discharged from post-anesthesia care.

      12. (L) Intensive care unit. The hospital must have an intensive care unit and/or pediatric intensive care unit that includes:

          1. (i) Compliance with OAC 310:667-15-7;
          2. (ii) A registered nurse on duty in the unit when it has a patient;
          3. (iii) A registered nurse on call when the unit does not have a patient;
          4. (iv) Written policies defining the minimum staffing requirements for the intensive care unitthat are monitored through the quality improvement program;
          5. (v) Nursing personnel have completed the Pediatric Advanced Life Support Program (PALS) offered through the American Heart Association or have equivalent training; and
          6. (vi) A physician with privileges in critical care must be on duty in the unit or immediately available in the hospital 24 hours a day.

      13. (M) Diagnostic imaging. The hospital must have diagnostic x-ray services available 24 hours a day. A radiology technologist and computerize tomography technologist will be on duty or on call and immediately available 24 hours a day. A single technologist designated as qualified by the radiologist in both diagnostic x-ray and computerized tomography procedures may be used to meet this requirement if an on call schedule of additional diagnostic imaging personnel is maintained. The diagnostic imaging services include:

          1. (i) Angiography;
          2. (ii) Ultrasonography;
          3. (iii) Computed tomography;
          4. (iv) Magnetic resonance imaging;
          5. (v) Neuroradiology; and
          6. (vi) Nuclear medicine imaging.

      14. (N) Clinical laboratory service. The hospital's clinical laboratory services must be available 24 hours a day. All or part of these services may be provided by arrangements with certified reference laboratories that are available on an emergency basis 24 hours a day. These services include:

          1. (i) all the clinical laboratory services listed for Level III classification as set forth in (b)(1)(K) of this Section; and
          2. (ii) Cerebrospinal fluid and other body fluid cell counts.
      15. (O) Respiratory therapy. Routine respiratory therapy procedures and mechanical ventilators will be available 24 hours a day. Respiratory therapy services will comply with OAC 310:667-23-6.
      16. (P) Social services. Social services must be available and provided in accordance with Subchapter 31 of this Chapter.
      17. (Q) Burn Care. A Level II hospital is subject to the same burn care requirements as a Level III hospital as set forth in (b)(1)(M) of this Section.
      18. (R) Spinal cord and head injury management. The hospital must provide acute spinal cord and head injury management including at least the ability to initiate rehabilitative care prior to transfer and must have a written transfer agreement with a hospital that provides comprehensive rehabilitation services if comprehensive rehabilitation services are not available within the hospital.
      19. (S) Rehabilitation services. A Level II hospital is subject to the same rehabilitation services requirements as a Level III hospital as set forth in (b)(1)(O)of this Section.
      20. (T) Acute hemodialysis. The hospital will have the capability to provide acute hemodialysis services 24 hours a day. All nursing staff providing hemodialysis patient care must have documented hemodialysis training and experience.

   2. (2) Personnel.

      1. (A) Pediatric trauma service director. The medical staff will designate a general or pediatric surgeon as trauma service director. The trauma service director's responsibilities include:

         1. (i) all trauma patients and administrative authority for the hospital's trauma program, through the quality improvement process; and
         2. (ii) appointments and removals from the trauma service.

      2. (B) Pediatric trauma coordinator. The hospital must have a designated trauma coordinator who may also serve as the prevention coordinator. Under the supervision of the trauma service director, the trauma coordinator is responsible for organizing the services and systems of the trauma service to ensure there is a multidisciplinary approach throughout the continuum of trauma care. The trauma coordinator will have an active role in the following:

         1. (i) Clinical activities such as design of clinical protocols, monitoring care, and assisting the staff in problem solving;
         2. (ii) Educational activities such as professional staff development, case reviews, continuing education, and community trauma education and prevention programs;
         3. (iii) Quality improvement activities such as development of quality monitors, audits, and case reviews in all phases of trauma care;
         4. (iv) Administrative tasks for the trauma service such as those related to services' organization, personnel, budget preparation, and accountability;
         5. (v) Trauma registry data collection, coding, scoring, and validation; and
         6. (vi) Consultation and liaison to the medical staff, prehospital emergency medical service agencies, patient families, and the community at large.
      3. (C) Prevention coordinator. The hospital will have a designated prevention coordinator who may also serve as the trauma coordinator. Under the supervision of the trauma director, the prevention coordinator is responsible for the organization and management of the hospital's outreach, prevention, and public education activities.
      4. (D) Emergency services director. The medical staff will designate a physician credentialed to provide emergency medical care as emergency services director.
      5. (E) Surgical director. The medical staff will designate a surgeon credentialed by the hospital to be the director of care for surgical and critical care for trauma patients.
      6. (F) Pediatric services director. The medical staff will designate a physician credentialed to provide pediatric care as pediatric services director.
      7. (G) Physician qualifications. A physician board certified, board eligible, or residency trained in pediatric critical care medicine will be available for consultation on site or immediately available by telephone or other electronic means 24 hours a day.
      8. (H) Training. Emergency room and intensive care personnel must have completed the Pediatric Advanced Life Support (PALS) program through the American Heart Association or have equivalent training.

   3. (3) Supplies and equipment.

      1. (A) Emergency department. The hospital must have equipment for use in the resuscitation of pediatric patients on site, functional, and immediately available, including at least the following:

         1. (i) the supplies and equipment listed for Level III classification in (a)(3)(A) through (O) in this Section;
         2. (ii) End-tidal CO2 determination;
         3. (iii) Apparatus to establish central venous pressure monitoring;
         4. (iv) Standard intravenous fluids and administration devices suitable for infants, children, and adults including infusion pumps with microinfusion capability and large-bore intravenous catheters;

         5. (v) Specialized pediatric procedure trays:

            1. (I) Lumbar puncture;
            2. (II) Urinary catheterization;
            3. (III) Umbilical vessel cannulation;
            4. (IV) Airway control/cricothyrotomy;
            5. (V) Thoracotomy;
            6. (VI) Chest decompression.
            7. (VII) Intraosseous infusion;
            8. (VIII) Vascular access;
            9. (IX) Needle cricothyroidotomy set; and
            10. (X) Peritoneal lavage.
         6. (vi) Slit lamp.

      2. (B) Operating suite. The operating suite must have the following supplies and equipment on site, functional and available for use:

         1. (i) Thermal control equipment for patients and infusion of blood, blood products, and other fluids;
         2. (ii) X-ray capability including c-arm intensifier;
         3. (iii) Equipment appropriate for fixation of long-bone and pelvic fractures;
         4. (iv) Craniotomy instruments; and
         5. (v) Endoscopes.

      3. (C) Post-anesthesia recovery unit. The post-anesthesia recovery unit will have the following supplies and equipment on site, functional, and available for use:

         1. (i) Equipment for the continuous monitoring of temperature, hemodynamics, and gas exchange;
         2. (ii) Equipment for the continuous monitoring of intracranial pressure;
         3. (iii) Thermal control equipment for patients and infusion of blood, blood products, and other fluids;
         4. (iv) End-tidal CO2 determination; and
         5. (v) Pulse oximetry.

      4. (D) Intensive care unit. The intensive care unit must have the following supplies and equipment on site, functional, and available for use:

         1. (i) Equipment for the continuous monitoring of temperature, hemodynamics, and gas exchange;
         2. (ii) Cardiopulmonary resuscitation cart;
         3. (iii) Electrocardiograph-oscilloscope-defibrillator-pacer;

         4. (iv) Sterile surgical sets for:

            1. (I) Airway control/cricothyrotomy;
            2. (II) Thoracotomy;
            3. (III) Vascular access; and
            4. (IV) Chest decompression.
   4. (4) Policies on transfers. The policies on transfers are as set forth in (a)(4)(A) of this Section (relating to agreements and policies on transfers).
   5. (5) Quality Improvement. A Level II hospital is subject to the same quality improvement requirements as a Level III hospital as set forth in (b)(5) of this Section.
   6. (6) Continuing education. The hospital will provide and document formal continuing education programs for physicians, nurses, allied health personnel, and community physicians. Continuing education programs will be available to all state physicians, nurses, allied health personnel, and emergency medical service providers.
   7. (7) Organ Procurement. The hospital, in association with an organ procurement organization certified by CMS, must create and maintain policies and procedures to identify and refer potential organ donors.

   8. (8) Outreach programs. The hospital will have organized outreach programs under the direction of a designated prevention coordinator.

      1. (A) Consultation. The hospital will provide on-site and/or electronic consultations with community health care providers and those in outlying areas as requested and appropriate.
      2. (B) Prevention and public education programs. The hospital will serve as a public information resource and collaborate with other institutions and national, regional, and state programs in research and data collection projects in epidemiology, surveillance, and injury prevention, and other areas.

4. (d) Level I. A Level I hospital will provide emergency pediatric medicine and trauma services with organized emergency and pediatrics departments and an organized pediatric trauma service with a designated pediatric surgeon as director. Pediatric surgery, pediatric anesthesiology, pediatric neurosurgery, and pediatric critical care services including a dedicated pediatric intensive care unit (PICU) must be available on site 24 hours a day. The hospital must have the prompt availability of additional clinical services and specialties such as pediatric cardiology, pediatric nephrology, and pediatric infectious disease specialists. A level I hospital also must have an organized trauma research program with a designated director. A hospital must be classified at Level I for emergency pediatric medicine and trauma services if it complies with all of this subsection:

   1. (1) Clinical services and resources.

      1. (A) Pediatric trauma service. A Level I hospital is subject to the same pediatric trauma service requirements as a Level II hospital as set forth in (c)(1)(A) of this Section.
      2. (B) Emergency services. A physician competent in the care of the critically injured pediatric patient and credentialed by the hospital to provide pediatric emergency medical services and nursing personnel with special capability in pediatric emergency and trauma care must be on site 24 hours a day. The emergency department has geographically separate and distinct pediatric medical/trauma areas that have all the staff, equipment, and skills necessary for comprehensive pediatric emergency care. Separate fully equipped pediatric resuscitation rooms must be available and capable of supporting at least two simultaneous resuscitations.
      3. (C) Poison control center. The hospital must have access by telephone or other electronic means to a regional poison control center.
      4. (D) Pediatric services. A Level I hospital is subject to the same pediatric services requirements as a Level II hospital as set forth in (c)(1)(D) of this Section.
      5. (E) Cardiac catheterization laboratory. The hospital must have a full-service cardiac catheterization laboratory or laboratories capable of providing both diagnostic and therapeutic procedures on the heart and great vessels for a wide variety of cardiovascular diseases. Diagnostic, therapeutic, and electrophysiology laboratories will be supervised by physicians with appropriate training and expertise in the procedures performed and who are properly credentialed by the medical staff. When primary percutaneous transluminal coronary angioplasty (PTCA) is performed, prompt access to emergency coronary arterial bypass graft (CABG) surgery must be available.
      6. (F) Pediatric surgery. A board certified, board eligible, or residency trained pediatric surgeon or senior surgical resident competent and appropriately credentialed by the hospital must be on site 24 hours a day and promptly available in the emergency department.
      7. (G) Pediatric anesthesia. A board certified, board eligible, or residency trained pediatric anesthesiologist must be on site 24 hours a day and promptly available in the emergency department. If the anesthesiologist is not present in the hospital before the physician's arrival, anesthesia services may be provided by a certified registered nurse anesthetist (CRNA). The CRNA must be considered competent in the assessment of emergent situations in pediatric patients and of initiating and providing any indicated treatment.
      8. (H) Neurologic surgery. A board certified, board eligible, or residency trained neurosurgeon or other physician competent in the care of pediatric patients with neurotrauma and appropriately credentialed must be on site 24 hours a day and promptly available in the emergency department. If care is initiated by a physician other than a neurosurgeon, the neurosurgeon on call will respond as required by the hospital's policy.
      9. (I) Orthopedics. A Level I hospital is subject to the same orthopedics requirements as a Level II hospital as set forth in (c)(1)(H) of this Section.

      10. (J) Other specialties. The hospital must also have the following specialty services on call and promptly available:

          1. (i) Cardiovascular surgery;
          2. (ii) Hand surgery;
          3. (iii) Microvascular surgery;
          4. (iv) Ophthalmology;
          5. (v) Oral/maxillofacial surgery;
          6. (vi) Otolaryngology;
          7. (vii) Pediatric allergy/immunology;
          8. (viii) Pediatric cardiology;
          9. (ix) Pediatric endocrinology;
          10. (x) Pediatric gastroenterology;
          11. (xi) Pediatric hematology/oncology;
          12. (xii) Pediatric infectious disease;
          13. (xiii) Pediatric intensivist;
          14. (xiv) Pediatric nephrology;
          15. (xv) Pediatric neurology;
          16. (xvi) Pediatric pulmonology;
          17. (xvii) Plastic surgery;
          18. (xviii) Psychiatry/psychology;
          19. (xix) Radiology; and
          20. (xx) Urology and urologic surgery.
      11. (K) Operating suite. A Level I hospital is subject to the same operating suite requirements as a Level II hospital as set forth in (c)(1)(J) of this Section.
      12. (L) Post-anesthesia recovery unit. A Level I hospital is subject to the same post-anesthesia recovery unit requirements as a Level II hospital as set forth in (c)(1)(K) of this Section.

      13. (M) Pediatric intensive care unit (PICU).

          1. (i) The hospital must have a pediatric intensive care unit that includes:

             1. (I) Compliance with OAC 310:667-15-7;
             2. (II) A registered nurse on duty in the intensive care unitwhen it has a patient;
             3. (III) A registered nurse on call and immediately available when the unit does not have a patient;
             4. (IV) Written policies defining the minimum staffing requirements for the pediatric intensive care unit;
             5. (V) A physician with privileges in pediatric critical care must be on duty in the unit or immediately available in the hospital 24 hours a day.
          2. (ii) The pediatric intensive care unit will be a distinct, separate unit within the hospital, with privileges of physicians and allied health personnel delineated in writing.

          3. (iii) The medical director and medical staff will establish and approve written policies for at least the following:

             1. (I) Admission/discharge;
             2. (II) Minimum staffing;
             3. (III) Patient monitoring;
             4. (IV) Safety;
             5. (V) Nosocomial infection;
             6. (VI) Patient isolation;
             7. (VII) Visitation;
             8. (VIII) Traffic control;
             9. (IX) Equipment operation and maintenance;
             10. (X) Coping with and recovering from the breakdown of essential equipment; and
             11. (XI) Patient record-keeping.
      14. (N) Diagnostic Imaging. A Level I hospital is subject to the same diagnostic imaging requirements as a Level II hospital as set forth in (c)(1)(M) of this Section.

      15. (O) Clinical laboratory service. The hospital's clinical laboratory services must be available 24 hours a day. All or part of these services may be provided by arrangements with certified reference laboratories that are available on an emergency basis 24 hours a day. The clinical laboratory must have the capability to analyze microspecimen volumes when appropriate. These services include:

          1. (i) Comprehensive immunohematology services including blood typing and compatibility testing;
          2. (ii) A supply of blood and blood products on hand that is properly stored and adequate to meet expected patient needs;
          3. (iii) Access to services provided by a community central blood bank;
          4. (iv) Standard analysis of blood, urine, and other body fluids to include routine chemistry and hematology testing;
          5. (v) Therapeutic drug monitoring;
          6. (vi) Cerebrospinal fluid and other body fluid cell counts;
          7. (vii) Coagulation studies;
          8. (viii) Blood gas/pH analysis;
          9. (ix) Comprehensive microbiology services with immediate availability of Gram stain preparations and at least appropriate supplies for the collection, preservation, and transport of clinical specimens for aerobic and anaerobic bacterial, mycobacterial, and fungus cultures; and
          10. (x) Drug and alcohol screening.
      16. (P) Respiratory therapy. A Level I hospital is subject to the same respiratory therapy requirements as a Level II hospital as set forth in (c)(1)(O) of this Section.
      17. (Q) Acute hemodialysis. The hospital must have the capability to provide acute hemodialysis services 24 hours a day. All nursing staff providing hemodialysis patient care must have documented hemodialysis training and experience with pediatric patients.
      18. (R) Social services. Social services must be available and provided in accordance with Subchapter 31 of this Chapter.
      19. (S) Physical and occupational therapy services. Physical and occupational therapy will be available and provided in accordance with Subchapter 23 of this Chapter.
      20. (T) Dietetic and nutrition services. Dietetic and nutrition services will be available and in accordance with Subchapter 17 of this Chapter.
      21. (U) Burn Care. A Level I hospital is subject to the same burn care requirements as a Level III hospital as set forth in (b)(1)(M) of this Section.
      22. (V) Spinal cord and head injury management. A Level I hospital is subject to the same spinal cord and head injury management requiremenst as a Level II hospital as set forth in (c)(1)(R) of this Section.
      23. (W) Rehabilitation services. A Level I hospital is subject to the same rehabilitation services requirements as a Level III hospital as set forth in (b)(1)(O) of this Section. A Level I hospital is subject to the same rehabilitation services requirements as a Level III hospital as set forth in (b)(1)(O) of this Section.

   2. (2) Personnel.

      1. (A) Pediatric trauma service director. The medical staff will designate a board certified, board eligible, or residency trained pediatric surgeon as pediatric trauma service director. Through the quality improvement process, the director's responsibilities include all pediatric trauma patients and administrative authority for the hospital's pediatric trauma program. The pediatric trauma service director will be responsible for recommending appointment to and removal from the pediatric trauma service.

      2. (B) Pediatric trauma coordinator. The hospital will have a designated pediatric trauma coordinator who may also serve as the prevention coordinator. Under the supervision of the pediatric trauma service director, the pediatric trauma coordinator is responsible for organizing the services and systems of the pediatric trauma service to ensure there is a multidisciplinary approach throughout the continuum of pediatric trauma care. The pediatric trauma coordinator will have an active role in the following:

         1. (i) Clinical activities such as design of clinical protocols, monitoring care, and assisting the staff in problem solving;
         2. (ii) Educational activities such as professional staff development, case reviews, continuing education, and community trauma education and prevention programs;
         3. (iii) Quality improvement activities such as development of quality monitors, audits, and case reviews in all phases of pediatric trauma care;
         4. (iv) Administrative tasks for the pediatric trauma service such as those related to services' organization, personnel, budget preparation, and accountability;
         5. (v) Trauma registry data collection, coding, scoring, and validation; and
         6. (vi) Consultation and liaison to the medical staff, prehospital emergency medical service agencies, patient families, and the community at large.
      3. (C) Prevention coordinator. The hospital will have a designated prevention coordinator who may also serve as the pediatric trauma coordinator. Under the supervision of the pediatric trauma director, the prevention coordinator is responsible for the organization and management of the hospital's outreach, prevention, and public education activities.
      4. (D) Emergency services director. The medical staff will designate a physician credentialed to provide pediatric emergency medical care as emergency services director.
      5. (E) Surgical director. The medical staff will designate a board certified, board eligible, or residency trained pediatric surgeon credentialed by the hospital to provide pediatric critical care as the surgical director for trauma patients.
      6. (F) Research director. The medical staff will designate a physician as research director who may also serve as the pediatric trauma service director. The research director is responsible for the organization and management of the hospital's trauma and emergency operative research activities.
      7. (G) PICU medical director. The medical staff will designate a physician board certified, board eligible, or residency trained in critical care medicine as PICU medical director. The PICU medical director will participate in developing and reviewing PICU policies, promote policy implementation, participate in budget preparation, help coordinate staff education, supervise resuscitation techniques, lead quality improvement activities, and coordinate research.
      8. (H) PICU nurse manager. The hospital will have a PICU nurse manager with training and experience in pediatric critical care dedicated to the PICU. The PICU nurse manager will participate in the development of written policies and procedures for the PICU, coordinate staff education, budget preparation, and coordination of research.

   3. (3) Supplies and equipment.

      1. (A) Emergency department. The hospital must have equipment for use in the resuscitation of pediatric patients on site, functional, and immediately available, including at least the following:

         1. (i) All the equipment listed for Level II classification as set forth in (c)(3)(A) of this Section;
         2. (ii) Portable electroencephalographic equipment; and
         3. (iii) Subdural access that is included as part of the specialized pediatric procedure tray.

      2. (B) Operating suite. The operating suite must have the following supplies and equipment on site, functional and available for use:

         1. (i) The operating suite equipment listed for Level II classification in (c)(3)(B)(i) through (iv) of this Section;
         2. (ii) Operating microscope;
         3. (iii) Cardiopulmonary bypass capability; and
         4. (iv) Pediatric endoscopes and bronchoscopes.

      3. (C) Post-anesthesia recovery unit. The post-anesthesia recovery unit will have the following supplies and equipment on site, functional, and available for use:

         1. (i) The post-anesthesia recovery unit equipment listed for Level II classification in (c)(3)(C)(i) through (iv); and
         2. (ii)
         3. (iii) Pulse oximeter with adult and pediatric probes.

      4. (D) Pediatric intensive care unit. The pediatric intensive care unit must have the following supplies and equipment on site, functional, and available for use:

         1. (i) Equipment for the continuous monitoring of temperature, hemodynamics, and gas exchange. Bedside monitors in the pediatric intensive care unit will have audible and visible high and low alarms for each statistic, provide a hard copy of the heart rhythm strip, and have the capability of simultaneously monitoring:

            1. (I) Systemic arterial pressure;
            2. (II) Central venous pressure;
            3. (III) Pulmonary arterial pressure;
            4. (IV) Intracranial pressures;
            5. (V) Heart rate and rhythm;
            6. (VI) Respiratory rate; and
            7. (VII) Temperature.
         2. (ii) Cardiopulmonary resuscitation cart;
         3. (iii) Electrocardiograph-oscilloscope-defibrillator-pacer;

         4. (iv) Sterile surgical sets for:

            1. (I) Airway control/cricothyrotomy;
            2. (II) Thoracotomy;
            3. (III) Vascular access; and
            4. (IV) Chest decompression.
   4. (4) Policies on transfers. The policies on transfersare as set forth in(a)(4)(A) of this Section (relating to agreements and policies on transfers).

   5. (5) Quality Improvement. In addition to any other quality improvement requirements governing the hospital, the quality improvement program must include:

      1. (A) Trauma committee. The hospital will establish a multidisciplinary committee composed of the trauma service director, emergency services director, trauma coordinator, and other members of the medical and nursing staff that treat trauma and emergency operative patients. The trauma committee will meet regularly to review and evaluate patient outcomes and the quality of care provided by the trauma service. The quality improvement program includes:

         1. (i) Trauma registry;
         2. (ii) Audit for all pediatric deaths to include prehospital care and care received at a transferring hospital;
         3. (iii) Incident reports related to pediatric patients;
         4. (iv) Pediatric transfers;
         5. (v) Child abuse cases;
         6. (vi) Pediatric cardiopulmonary or respiratory arrests;
         7. (vii) Pediatric admissions within 48 hours of an emergency department visit;
         8. (viii) Pediatric surgery within 48 hours of discharge from an emergency department;
         9. (ix) Morbidity and mortality review;
         10. (x) Regularly scheduled multidisciplinary trauma and emergency operative services review conference;
         11. (xi) Medical nursing audit, utilization review, tissue review;
         12. (xii) Published on call schedules for surgeons, neurosurgeons, and orthopedic surgeons;
         13. (xiii) Review of the times and reasons for trauma-related bypass;
         14. (xiv) The availability and response times of on call staff specialists will be defined in writing, documented, and continuously monitored; and
         15. (xv) Quality improvement staff with the time dedicated to and specific for trauma and emergency operative services.

      2. (B) PICU committee. The hospital will establish a PICU committee composed of physicians, nurses, and other allied health personnel directly involved with activities in the PICU. The PICU committee will meet regularly to review and evaluate patient outcomes and the quality of care provided by the PICU. The PICU quality improvement program may be conducted in conjunction with the trauma and emergency operative services program and includes:

         1. (i) Special audit for all PICU deaths;
         2. (ii) Morbidity and mortality review;
         3. (iii) Medical nursing audit, utilization review, tissue review;
         4. (iv) Regularly scheduled multidisciplinary PICU review conference;
         5. (v) Review of prehospital care;
         6. (vi) Published on call schedules for surgeons, neurosurgeons, and orthopedic surgeons; and
         7. (vii) The availability and response times of on call staff specialists must be defined in writing, documented, and continuously monitored.
   6. (6) Continuing education. A Level I hospital is subject to the same continuing education requirements as a Level II hospital as set forth in (c)(6) of this Section.
   7. (7) Organ Procurement. A Level I hospital is subject to the same organ procurement requirements as a Level II hospital as set forth in (c)(7) of this Section.
   8. (8) Outreach programs. A Level I hospital is subject to the same outreach program requirements as a Level II hospital as set forth in (c)(8) in this Section.
   9. (9) Research programs. The hospital will have an organized pediatric services research program under the direction of a designated research director. Research groups will meet regularly and all research proposals will be approved by an Institutional Review Board (IRB) prior to launch. The research director will maintain evidence of the productivity of the research program through documentation of presentations and copies of published articles.

Added at 17 Ok Reg 2992, eff 7-13-00

Amended at 20 Ok Reg 1664, eff 6-12-03

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