Classification of trauma and emergency operative

services (a) Level IV. A Level IV facility shall provide emergency medical services with at least a licensed independent practitioner, registered nurse, licensed practical nurse, or intermediate or paramedic level emergency medical technician on site twenty-four (24) hours a day. A hospital shall be classified at Level IV for trauma and emergency operative services if it meets the following requirements: (1) Clinical services and resources. No diagnostic, surgical, or medical specialty services are required. (2) Personnel. A physician, licensed independent practitioner, registered nurse, licensed practical nurse, or intermediate or paramedic level emergency medical technician shall be on site twenty- four (24) hours a day. In the absence of a physician, licensed independent practitioner, registered nurse, or paramedic level emergency medical technician, at least one of the practitioners on duty shall have received training in advanced life support techniques and be deemed competent to initiate treatment of the emergency patient. (A) If the facility is licensed as a General-Medical Surgical Hospital, it shall also meet the personnel and staffing requirements at OAC 310:667-29-1 and any other applicable parts of this Chapter. (B) If the facility provides emergency medical services and is licensed as a Specialized Hospital: Psychiatric, it shall also meet the personnel and staffing requirements at OAC 310:667-33-2 and any other applicable parts of this Chapter. (C) If the facility provides emergency medical services and is licensed as a Specialized Hospital: Rehabilitation, it shall also meet the personnel and staffing requirements at OAC 310:667-35-3 and any other applicable parts of this Chapter. (D) If the facility provides emergency medical services and is licensed as a Critical Access Hospital, it shall also meet the personnel and staffing requirements at OAC 310:667-39-14 and any other applicable parts of this Chapter. (3) Supplies and equipment. The hospital shall have equipment for use in the resuscitation of patients of all ages on site, functional, and immediately available, including at least the following: (A) Airway control and ventilation equipment, including laryngoscopes and endotracheal tubes of all sizes, bag-mask resuscitator, pocket masks, and oxygen; (B) Suction devices; (C) Electrocardiograph-oscilloscope-defibrillator-pacer; (D) Standard intravenous fluids and administration devices, including large-bore intravenous catheters; (E) Sterile surgical sets for: (i) Airway control/cricothyrotomy; OAC 310:667 OKLAHOMA STATE DEPARTMENT OF HEALTH 129 September 13, 2019 (ii) Vascular access; and (iii) Chest decompression. (F) Equipment for gastric decompression; (G) Drugs necessary for emergency care; (H) Two-way communication with vehicles of emergency transport system as required at OAC 310:667-29-1(c)(4); and (I) Thermal control equipment for patients. (4) Agreements and policies on transfers. (A) The hospital shall have written policies defining the medical conditions and circumstances for those emergency patients which may be retained for treatment in-house, and for those who require stabilizing treatment and transfer to another facility. (B) The facility shall have a transfer agreement with a hospital capable of providing trauma care for severely injured patients. This agreement shall include reciprocal provisions requiring the facility to accept return transfers of patients at such time as the facility has the capability and capacity to provide needed care. Reciprocal agreements shall not incorporate financial provisions for transfers. (C) The facility shall 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. (D) The facility shall have transfer agreements with a hospital capable of providing acute spinal cord and head injury management and rehabilitation. (E) The facility shall 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. (5) Quality Improvement. (A) For a hospital licensed as a general medical surgical hospital, in addition to the requirements of OAC 310:667-11-1 through OAC 310:667-11-5, the quality improvement programs shall include: (i) Trauma registry; (ii) Audit for all trauma deaths to include prehospital care and care received at a transferring facility; (iii) Morbidity and mortality review; (iv) Medical nursing audit, utilization review, tissue review; and (v) The availability and response times of on call staff specialists shall be defined in writing, documented, and continuously monitored. (B) For a hospital licensed as a critical access hospital, in addition to the requirements of OAC 310:667-39-7, the quality improvement programs shall include: (i) A trauma registry; (ii) Audit for all trauma deaths to include prehospital care and care received at a transferring facility; (iii) Morbidity and mortality review; OAC 310:667 OKLAHOMA STATE DEPARTMENT OF HEALTH 130 September 13, 2019 (iv) Medical nursing audit, utilization review, tissue review; and (v) The availability and response times of on call staff specialists shall be continuously monitored and documented. (C) For a facility licensed as a birthing center, in addition to the requirements of OAC 310:667-616-5-2, the quality improvement programs shall include: (i) Trauma registry; (ii) Audit for all trauma deaths to include prehospital care and care received at a transferring facility; (iii) Morbidity and mortality review; (iv) Medical nursing audit, utilization review, tissue review; and (v) The availability and response times of on call staff specialists shall be continuously monitored and documented. (b) Level III. A Level III facility shall provide emergency medical services with an organized trauma service and emergency department. A physician and nursing staff with special capability in trauma care shall be on site twenty-four (24) hours a day. General surgery and anesthesiology services shall be available either on duty or on call. A hospital shall be classified at Level III for trauma and emergency operative services if it meets the following requirements: (1) Clinical services and resources. (A) Trauma service. A trauma service shall be established by the medical staff and shall be responsible for coordinating the care of injured patients, the training of personnel, and trauma quality improvement. Privileges for physicians participating in the trauma service shall be determined by the medical staff credentialing process. All patients with multiple-system or major injury shall be evaluated by the trauma service. The surgeon responsible for the overall care of the admitted patient shall be identified. (B) Emergency services. A physician deemed competent in the care of the critically injured and credentialed by the hospital to provide emergency medical services and nursing personnel with special capability in trauma care shall be on site twenty-four (24) hours a day. The emergency service may also serve as the trauma service. (i) For a hospital licensed as a general medical surgical hospital or specialty hospital, emergency services shall also comply with the requirements of OAC 310:667-29-1 through OAC 310:667-29-2. (ii) For a hospital licensed as a critical access hospital, emergency services shall also comply with OAC 310:667-39-14. (C) General surgery. A board certified, board eligible, or residency trained general surgeon shall be on call twenty-four (24) hours a day and promptly available in the emergency department. For a hospital licensed as a general medical surgical hospital, surgical services shall also comply with the requirements of OAC 310:667-25-1 through OAC 310:667-25-2. (D) Anesthesia. Anesthesia services shall be on call twenty-four (24) hours a day, promptly available, and administered as required in OAC 310:667-25-2. OAC 310:667 OKLAHOMA STATE DEPARTMENT OF HEALTH 131 September 13, 2019 (E) Internal medicine. A physician board certified, board eligible, or residency trained in internal medicine shall be on call twenty-four (24) hours a day and promptly available in the emergency department. (F) Orthopedic Surgery. A physician board certified, board eligible, or residency trained in orthopedics and deemed competent in the care of orthopedic emergencies shall be on site or on call twenty-four (24) hours a day and promptly available in the emergency department. In the absence of the orthopedic surgeon, a physician designated by the trauma director and credentialed to provide stabilizing emergency orthopedic treatment may provide care prior to transfer. (G) Operating suite. An operating suite with thermal control equipment for patients and infusion of blood and fluids shall be available twenty-four (24) hours a day. (H) Post-anesthesia recovery unit. The hospital shall have a post-anesthesia recovery room or intensive care unit 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. (I) Intensive care unit. The hospital shall have an intensive care unit in compliance with OAC 310:667-15-7 with a registered nurse on duty in the intensive care unit whenever the unit has a patient(s). A registered nurse shall be on call and immediately available when no patients are in the unit. The hospital shall define and document in writing the minimum staffing requirements for the intensive care unit and shall monitor compliance with these requirements through the quality improvement program. (J) Diagnostic imaging. The hospital shall have diagnostic x-ray services available twenty-four (24) hours a day. A radiology technologist shall be on duty or on call and immediately available twenty-four (24) hours a day. (i) For hospitals licensed as general medical surgical hospitals or specialty hospitals, diagnostic imaging services shall also comply with the applicable requirements in Subchapter 23 of this Chapter. (ii) For hospitals licensed as critical access hospitals, diagnostic imaging services shall also comply with the applicable requirements in Subchapter 39 of this Chapter. (K) Clinical laboratory service. The hospital shall have clinical laboratory services available twenty-four (24) hours a day. All or part of these services may be provided by arrangements with certified reference laboratories provided these services are available on an emergency basis twenty-four (24) hours a day. At least the following shall be available: (i) Comprehensive immunohematology services including blood typing and compatibility testing. A supply of blood and blood products shall be on hand and adequate to meet expected patient needs. All blood and blood products shall be properly stored. The hospital shall have access to services provided by a community central blood bank; (ii) Standard analysis of blood, urine, and other body fluids to include routine chemistry and hematology testing; OAC 310:667 OKLAHOMA STATE DEPARTMENT OF HEALTH 132 September 13, 2019 (iii) Coagulation studies; (iv) Blood gas/pH analysis; (v) Comprehensive microbiology services or appropriate supplies for the collection, preservation, and transport of clinical specimens for aerobic and anaerobic bacterial, mycobacterial, and fungus cultures; and (vi) Drug and alcohol screening. (vii) For hospitals licensed as general medical surgical hospitals or specialty hospitals, clinical laboratory services shall also comply with the applicable requirements in Subchapter 23 of this Chapter. (viii) For hospitals licensed as critical access hospitals, clinical laboratory services shall also comply with the applicable requirements in Subchapter 39 of this Chapter. (L) Social services. Social services shall be available and provided as required in Subchapter 31 of this Chapter. (M) Burn Care. If the hospital does not meet the requirements at OAC 310:667-59-9(d)(1)(O)(i) it shall have a transfer agreement 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. (N) Spinal cord and head injury management. If the hospital does not meet the requirements at OAC 310:667-59-9(d)(1)(P)(i) it shall have a transfer agreement with a hospital capable of providing acute spinal cord and head injury management and rehabilitation. (O) Rehabilitation services. If the hospital does not meet the requirements at OAC 310:667-59-9(d)(1)(Q)(i) it shall have a transfer agreement with a hospital which meets the requirements of Subchapter 35 of this Chapter and is 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. (2) Personnel. (A) Trauma service director. The medical staff shall designate a surgeon as trauma service director. Through the quality improvement process, the director shall have responsibility for all trauma patients and administrative authority for the hospital's trauma program. The director shall be responsible for recommending appointment to and removal from the trauma service. (B) Emergency services director. The medical staff shall designate a physician credentialed to provide emergency medial care as emergency services director. The emergency services director may serve as the trauma service director. (C) Surgical director. The medical staff shall designate a surgeon credentialed by the hospital to be the director of care for surgical and critical care for trauma patients. (3) Supplies and equipment. (A) Emergency department. The emergency department shall have equipment for use in the resuscitation of patients of all ages on site, functional, and available in the emergency department, including at least the following: (i) Airway control and ventilation equipment, including OAC 310:667 OKLAHOMA STATE DEPARTMENT OF HEALTH 133 September 13, 2019 laryngoscopes and endotracheal tubes of all sizes, bag-mask resuscitator, pocket masks, and oxygen; (ii) Pulse oximetry; (iii) Suction devices; (iv) Electrocardiograph-oscilloscope-defibrillator-pacer; (v) Apparatus to establish central venous pressure monitoring; (vi) Standard intravenous fluids and administration devices, including large-bore intravenous catheters; (vii) Sterile surgical sets for: (I) Airway control/cricothyrotomy; (II) Thoracotomy; (III) Vascular access; and (IV) Chest decompression. (viii) Equipment for gastric decompression; (ix) Drugs necessary for emergency care; (x) Two-way communication with vehicles of emergency transport system as required at OAC 310:667-29-1(c)(4); (xi) Skeletal traction devices including cervical immobilization device; and (xii) Thermal control equipment for patients and infusion of blood, blood products, and other fluids. (B) Post-anesthesia recovery unit. The post-anesthesia recovery unit shall have the following supplies and equipment on site, functional, and available for use: (i) Equipment for the continuous monitoring of temperature, hemodynamics, and gas exchange; (ii) Pulse oximetry; (iii) End-tidal CO2 determination; and (iv) Thermal control equipment for patients and infusion of blood, blood products, and other fluids. (C) Intensive care unit. The intensive care unit shall have the following supplies and equipment on site, functional, and available for use: (i) Equipment for the continuous monitoring of temperature, hemodynamics, and gas exchange; (ii) Cardiopulmonary resuscitation cart; (iii) Electrocardiograph-oscilloscope-defibrillator-pacer; (iv) Sterile surgical sets for: (I) Airway control/cricothyrotomy; (II) Thoracotomy; (III) Vascular access; and (IV) Chest decompression. (4) Policies on transfers. (A) The hospital shall have written policies defining the medical conditions and circumstances for those emergency patients which may be retained for treatment in-house, and for those who require stabilizing treatment and transfer to another facility. (B) The facility shall have a transfer agreement with a hospital capable of providing trauma care for severely injured patients. This agreement shall include reciprocal provisions requiring the facility to accept return transfers of patients at such time as the facility has the capability and capacity to provide needed OAC 310:667 OKLAHOMA STATE DEPARTMENT OF HEALTH 134 September 13, 2019 care. Reciprocal agreements shall not incorporate financial provisions for transfers. (5) Quality Improvement. In addition to any other requirements of this Chapter, the hospital quality improvement program shall include: (A) Trauma registry; (B) Audit for all trauma deaths to include prehospital care and care received at a transferring facility; (C) Morbidity and mortality review; (D) Medical nursing audit, utilization review, tissue review; (E) Multidisciplinary peer review of trauma and emergency services; (F) Published on call schedules for surgeons, neurosurgeons, and orthopedic surgeons; (G) Review of the times and reasons for trauma-related bypass; and (H) The availability and response times of on call staff specialists shall be defined in writing, documented, and continuously monitored. (6) Continuing education. The hospital shall provide and document formal continuing education programs for physicians, nurses, and allied health personnel. (7) Organ Procurement. The hospital, in association with an organ procurement organization certified by the CMS, shall develop policies and procedures to identify and refer potential organ donors. (c) Level II. A Level II facility shall provide emergency medical services with an organized trauma service and emergency department. A physician and nursing staff with special capability in trauma care shall be on site twenty-four (24) hours a day. General surgery, anesthesiology, and neurosurgery services shall be available on site or on call twenty-four (24) hours a day. Services from an extensive group of clinical specialties including cardiology, internal medicine, orthopedics, and obstetrics/gynecology shall be promptly available on call. A hospital shall be classified at Level II for trauma and emergency operative services if it meets the following requirements: (1) Clinical services and resources. (A) Trauma service. A trauma service shall be established by the medical staff and shall be responsible for coordinating the care of injured patients, the training of personnel, and trauma quality improvement. Privileges for physicians participating in the trauma service will be determined by the medical staff credentialing process. All patients with multiple-system or major injury shall be evaluated by the trauma service. The surgeon responsible for the overall care of the admitted patient shall be identified. (B) Emergency services. A physician deemed competent in the care of the critically injured and credentialed by the hospital to provide emergency medical services and nursing personnel with special capability in trauma care shall be on site twenty-four (24) hours a day. For a hospital licensed as a general medical surgical hospital or specialty hospital, emergency services shall also comply with the requirements of OAC 310:667-29-1 through OAC 310:667-29-2. (C) General surgery. A general surgeon or senior surgical OAC 310:667 OKLAHOMA STATE DEPARTMENT OF HEALTH 135 September 13, 2019 resident deemed competent and appropriately credentialed by the hospital shall be on site or on call twenty-four (24) hours a day and promptly available in the emergency department. A stated goal of the general surgery service shall be to have the attending trauma surgeon authorized and designated by the trauma service director present in the emergency room at the time of the severely injured patient's arrival. For a hospital licensed as a general medical surgical hospital, surgical services shall also comply with the requirements of OAC 310:667-25-1 through OAC 310:667-25- 2. (D) Anesthesia. A board certified, board eligible, or residency trained anesthesiologist shall be on site or on call twenty-four (24) hours a day and promptly available in the emergency department. If the anesthesiologist is not present in the facility, prior to the physician's arrival, anesthesia services may be provided by a certified registered nurse anesthetist (CRNA). The CRNA shall be deemed competent in the assessment of emergent situations in trauma patients and of initiating and providing any indicated treatment. All anesthesia shall be administered as required in OAC 310:667-25-2. (E) Neurologic surgery. A board certified, board eligible, or residency trained neurosurgeon or other physician deemed competent in the care of patients with neurotrauma and appropriately credentialed shall be on site or on call twenty-four (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 shall respond as required by the hospital's policy. (F) Other specialties. The hospital shall also have services from the following specialties on call and promptly available: (i) Cardiac surgery; (ii) Cardiology; (iii) Internal medicine; (iv) Obstetric/gynecologic surgery; (v) Ophthalmic surgery; (vi) Oral/maxillofacial surgery; (vii) Orthopedic surgery; (viii) Otolaryngology; (ix) Pediatrics; (x) Plastic surgery; (xi) Clinical licensed psychologist or psychiatrist; (xii) Pulmonary medicine; (xiii) Radiology; (xiv) Thoracic surgery; and (xv) Urology and urologic surgery. (G) Operating suite. An operating suite with adequate staff and equipment shall be immediately available twenty-four (24) hours a day. The hospital shall define and document in writing the minimum staffing requirements for the operating suite. An on call schedule for emergency replacement staff shall be maintained. (H) Post-anesthesia recovery unit. The hospital shall have a post-anesthesia recovery room or intensive care unit in compliance with OAC 310:667-15-7 with nursing personnel and anesthesia OAC 310:667 OKLAHOMA STATE DEPARTMENT OF HEALTH 136 September 13, 2019 services remaining in the unit until the patient is discharged from post-anesthesia care. (I) Intensive care unit. The hospital shall have an intensive care unit in compliance with OAC 310:667-15-7 with a registered nurse on duty in the intensive care unit whenever the unit has a patient(s). The hospital shall define and document in writing the minimum staffing requirements for the intensive care unit and shall continuously monitor compliance with these requirements through the quality improvement program. A registered nurse shall be on call and immediately available when no patients are in the unit. A physician with privileges in critical care shall be on duty in the unit or immediately available in the hospital twenty- four (24) hours a day. (J) Diagnostic Imaging. The hospital shall have diagnostic x-ray services available twenty-four (24) hours a day. A radiologic technologist and computerized tomography technologist shall be on duty or on call and immediately available twenty-four (24) hours a day. A single technologist designated as qualified in both diagnostic x-ray and computerized tomography procedures by the radiologist may be used to meet this requirement if an on call schedule of additional diagnostic imaging personnel is maintained. The diagnostic imaging service shall provide at least the following services: (i) Angiography; (ii) Ultrasonography; (iii) Computed tomography; (iv) Magnetic resonance imaging; (v) Neuroradiology; and (vi) Nuclear medicine imaging. (vii) For a hospital licensed as a general medical surgical hospital or specialty hospital, diagnostic imaging services shall also comply with the applicable requirements in Subchapter 23 of this Chapter. (K) Clinical laboratory service. The hospital shall have clinical laboratory services available twenty-four (24) hours a day. All or part of these services may be provided by arrangements with certified reference laboratories provided these services are available on an emergency basis twenty-four (24) hours a day. At least the following shall be available: (i) Comprehensive immunohematology services including blood typing and compatibility testing. A supply of blood and blood products shall be on hand and adequate to meet expected patient needs. All blood and blood products shall be properly stored. The hospital shall have access to services provided by a community central blood bank; (ii) Standard analysis of blood, urine, and other body fluids to include routine chemistry and hematology testing; (iii) Coagulation studies; (iv) Blood gas/pH analysis; (v) Comprehensive microbiology services or appropriate supplies for the collection, preservation, and transport of clinical specimens for aerobic and anaerobic bacterial, mycobacterial, and fungus cultures; and OAC 310:667 OKLAHOMA STATE DEPARTMENT OF HEALTH 137 September 13, 2019 (vi) Drug and alcohol screening. (vii) For a hospital licensed as general medical surgical hospital or specialty hospital, clinical laboratory services shall also comply with the applicable requirements in Subchapter 23 of this Chapter. (L) Respiratory therapy. Routine respiratory therapy procedures and mechanical ventilators shall be available twenty-four (24) hours a day. Respiratory therapy services shall comply with OAC 310:667-23-6. (M) Social services. Social services shall be available and provided as required in Subchapter 31 of this Chapter. (N) Burn Care. If the hospital does not meet the requirements at OAC 310:667-59-9(d)(1)(O)(i) it shall have a transfer agreement 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. (O) Spinal cord and head injury management. The hospital shall provide acute spinal cord and head injury management including at least the ability to initiate rehabilitative care prior to transfer and shall have a transfer agreement with a hospital that meets the requirements at OAC 310:667-59-9(d)(1)(P)(i) if comprehensive rehabilitation services are not available within the facility. (P) Rehabilitation services. If the hospital does not meet the requirements at OAC 310:667-59-9(d)(1)(Q)(i) it shall have a transfer agreement with a hospital which meets the requirements of Subchapter 35 of this Chapter and is 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. (2) Personnel. (A) Trauma service director. The medical staff shall designate a surgeon as trauma service director. Through the quality improvement process, the director shall have responsibility for all trauma patients and administrative authority for the hospital's trauma program. The trauma service director shall be responsible for recommending appointment to and removal from the trauma service. (B) Trauma coordinator. The hospital shall 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 shall have an active role in the following: (i) Clinical activities such as design of clinical protocols, monitoring care, and assisting the staff in problem solving; (ii) Educational activities such as professional staff development, case reviews, continuing education, and community trauma education and prevention programs; OAC 310:667 OKLAHOMA STATE DEPARTMENT OF HEALTH 138 September 13, 2019 (iii) Quality improvement activities such as development of quality monitors, audits, and case reviews in all phases of trauma care; (iv) Administrative tasks for the trauma service such as those related to services' organization, personnel, budget preparation, and accountability; (v) Trauma registry data collection, coding, scoring, and validation; and (vi) Consultation and liaison to the medical staff, prehospital emergency medical service agencies, patient families, and the community at large. (C) Prevention coordinator. The hospital shall 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. (D) Emergency services director. The medical staff shall designate a physician credentialed to provide emergency medical care as emergency services director. (E) Surgical director. The medical staff shall designate a surgeon credentialed by the hospital to be the director of care for surgical and critical care for trauma patients. (3) Supplies and equipment. (A) Emergency department. The emergency department shall have equipment for use in the resuscitation of patients of all ages on site, functional, and available in the emergency department, including at least the following: (i) Airway control and ventilation equipment, including laryngoscopes and endotracheal tubes of all sizes, bag-mask resuscitator, pocket masks, and oxygen; (ii) Pulse oximetry; (iii) End-tidal CO2 determination; (iv) Suction devices; (v) Electrocardiograph-oscilloscope-defibrillator-pacer; (vi) Apparatus to establish central venous pressure monitoring; (vii) Standard intravenous fluids and administration devices, including large-bore intravenous catheters; (viii) Sterile surgical sets for: (I) Airway control/cricothyrotomy; (II) Thoracotomy; (III) Vascular access; and (IV) Chest decompression. (ix) Equipment for gastric decompression; (x) Drugs necessary for emergency care; (xi) Two-way communication with vehicles of emergency transport system as required at OAC 310:667-29-1(c)(4); (xii) Skeletal traction devices including cervical immobilization device; (xiii) Arterial catheters; and (xiv) Thermal control equipment for patients and infusion of blood, blood products, and other fluids. OAC 310:667 OKLAHOMA STATE DEPARTMENT OF HEALTH 139 September 13, 2019 (B) Operating suite. The operating suite shall have the following supplies and equipment on site, functional and available for use: (i) Thermal control equipment for patients and infusion of blood, blood products, and other fluids; (ii) X-ray capability including c-arm intensifier; (iii) Endoscopes; (iv) Craniotomy instruments; and (v) Equipment appropriate for fixation of long-bone and pelvic fractures. (C) Post-anesthesia recovery unit. The post-anesthesia recovery unit shall have the following supplies and equipment on site, functional, and available for use: (i) Equipment for the continuous monitoring of temperature, hemodynamics, and gas exchange; (ii) Equipment for the continuous monitoring of intracranial pressure; (iii) Pulse oximetry; (iv) End-tidal CO2 determination; and (v) Thermal control equipment for patients and infusion of blood, blood products, and other fluids. (D) Intensive care unit. The intensive care unit shall have the following supplies and equipment on site, functional, and available for use: (i) Equipment for the continuous monitoring of temperature, hemodynamics, and gas exchange; (ii) Cardiopulmonary resuscitation cart; (iii) Electrocardiograph-oscilloscope-defibrillator-pacer; (iv) Sterile surgical sets for: (I) Airway control/cricothyrotomy; (II) Thoracotomy; (III) Vascular access; and (IV) Chest decompression. (4) Policies on transfers. The hospital shall have written policies defining the medical conditions and circumstances for those emergency patients which may be retained for treatment in-house, and for those who require stabilizing treatment and transfer to another facility. (5) Quality Improvement. The hospital shall establish a multidisciplinary trauma 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 shall meet regularly to review and evaluate patient outcomes and the quality of care provided by the trauma service. In addition to any other requirements of this Chapter, the hospital quality improvement program shall include: (A) Trauma registry; (B) Audit for all trauma deaths to include prehospital care and care received at a transferring facility; (C) Morbidity and mortality review; (D) Medical nursing audit, utilization review, tissue review; (E) Regularly scheduled multidisciplinary trauma and emergency OAC 310:667 OKLAHOMA STATE DEPARTMENT OF HEALTH 140 September 13, 2019 operative services review conferences; (F) Published on call schedules for surgeons, neurosurgeons, and orthopedic surgeons; (G) Review of the times and reasons for trauma-related bypass; (H) The availability and response times of on call staff specialists shall be defined in writing, documented, and continuously monitored; and (I) Quality improvement staff with time dedicated to and specific for trauma and emergency operative services. (6) Continuing education. The hospital shall provide and document formal continuing education programs for physicians, nurses, allied health personnel, and community physicians. Continuing education programs shall be available to all state physicians, nurses, allied health personnel, and emergency medical service providers. (7) Organ Procurement. The hospital, in association with an organ procurement organization certified by CMS, shall develop policies and procedures to identify and refer potential organ donors. (8) Outreach programs. The hospital shall have organized outreach programs under the direction of a designated prevention coordinator. (A) Consultation. The hospital shall provide on-site and/or electronic consultations with community health care providers and those in outlying areas as requested and appropriate. (B) Prevention and public education programs. The hospital shall 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. (d) Level I. A Level one facility shall provide emergency medical services with an organized trauma service and emergency department. A physician and nursing staff with special capability in trauma care shall be on site twenty-four (24) hours a day. General surgery, anesthesiology, and neurosurgery services shall be available on site or on call twenty-four (24) hours a day. Additional clinical services and specialties such as nuclear diagnostic imaging, cardiac surgery, hand surgery, and infectious disease specialists shall also be promptly available. A Level I facility shall also have an organized trauma research program with a designated director. (1) Clinical services and resources. (A) Trauma service. A trauma service shall be established by the medical staff and shall be responsible for coordinating the care of injured patients, the training of personnel, and trauma quality improvement. Privileges for physicians participating in the trauma service will be determined by the medical staff credentialing process. All patients with multiple-system or major injury shall be evaluated by the trauma service. The surgeon responsible for the overall care of the admitted patient shall be identified. (B) Emergency services. A physician deemed competent in the care of the critically injured and credentialed by the hospital to provide emergency medical services and nursing personnel with special capability in trauma care shall be on site twenty-four (24) hours a day. For a hospital licensed as a general medical surgical hospital or a specialty hospital, emergency services OAC 310:667 OKLAHOMA STATE DEPARTMENT OF HEALTH 141 September 13, 2019 shall also comply with the requirements of OAC 310:667-29-1 through OAC 310:667-29-2. (C) General surgery. A general surgeon or senior surgical resident deemed competent and appropriately credentialed by the hospital shall be on site or on call twenty-four (24) hours a day and promptly available in the emergency department. A stated goal of the general surgery service shall be to have the attending trauma surgeon authorized and designated by the trauma service director present in the emergency room at the time of the severely injured patient's arrival. For a hospital licensed as a general medical surgical hospital, surgical services shall also comply with the requirements of OAC 310:667-25-1 through OAC 310:667-25- 2. (D) Anesthesia. A board certified, board eligible, or residency trained anesthesiologist shall be on site or on call twenty-four (24) hours a day and promptly available. All anesthesia shall be administered as required in OAC 310:667-25-2. (E) Neurologic surgery. A board certified, board eligible, or residency trained neurosurgeon or other physician deemed competent in the care of patients with neurotrauma and appropriately credentialed shall be on site twenty-four (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 shall respond as required by the hospital's policy. (F) Other specialties. The hospital shall also have services from the following specialties on call and promptly available: (i) Cardiac surgery; (ii) Cardiology; (iii) Hand surgery; (iv) Infectious disease; (v) Internal medicine; (vi) Microvascular surgery; (vii) Obstetric/gynecologic surgery; (viii) Ophthalmic surgery; (ix) Oral/maxillofacial surgery; (x) Orthopedic surgery; (xi) Otolaryngology; (xii) Pediatric surgery; (xiii) Pediatrics; (xiv) Plastic surgery; (xv) Clinical licensed psychologist or psychiatrist; (xvi) Pulmonary medicine; (xvii) Radiology; (xviii) Thoracic surgery; and (xvix) Urology and urologic surgery. (G) Operating suite. An operating suite with adequate staff and equipment shall be immediately available twenty-four (24) hours a day. The hospital shall define and document in writing the minimum staffing requirements for the operating suite. An on call schedule for emergency replacement staff shall be maintained. (H) Post-anesthesia recovery unit. The hospital shall have a post-anesthesia recovery room or intensive care unit in compliance OAC 310:667 OKLAHOMA STATE DEPARTMENT OF HEALTH 142 September 13, 2019 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. (I) Intensive care unit. The hospital shall have an intensive care unit in compliance with OAC 310:667-15-7 with a registered nurse on duty in the intensive care unit whenever the unit has a patient(s). The hospital shall define and document in writing the minimum staffing requirements for the intensive care unit and shall continuously monitor compliance with these requirements through the quality improvement program. A registered nurse shall be on call and immediately available when no patients are in the unit. A physician with privileges in critical care shall be on duty in the unit or immediately available in the hospital twenty- four (24) hours a day. (J) Diagnostic Imaging. The hospital shall have diagnostic x-ray services available twenty-four (24) hours a day. A radiologic technologist and computerized tomography technologist shall be on duty or on call and immediately available twenty-four (24) hours a day. A single technologist designated as qualified in both diagnostic x-ray and computerized tomography procedures by the radiologist may be used to meet this requirement if an on call schedule of additional diagnostic imaging personnel is maintained. The diagnostic imaging service shall provide at least the following services: (i) Angiography; (ii) Ultrasonography; (iii) Computed tomography; (iv) Magnetic resonance imaging; (v) Neuroradiology; and (vi) Nuclear medicine imaging. (vii) For a hospital licensed as a general medical surgical hospital or specialty hospital, diagnostic imaging services shall also comply with the applicable requirements in Subchapter 23 of this Chapter. (K) Clinical laboratory service. The hospital shall have clinical laboratory services available twenty-four (24) hours a day. All or part of these services may be provided by arrangements with certified reference laboratories provided these services are available on an emergency basis twenty-four (24) hours a day. At least the following shall be available: (i) Comprehensive immunohematology services including blood typing and compatibility testing. A supply of blood and blood products shall be on hand and adequate to meet expected patient needs. All blood and blood products shall be properly stored. The hospital shall have access to services provided by a community central blood bank; (ii) Standard analysis of blood, urine, and other body fluids to include routine chemistry and hematology testing; (iii) Coagulation studies; (iv) Blood gas/pH analysis; (v) Comprehensive microbiology services or appropriate supplies for the collection, preservation, and transport of clinical specimens for aerobic and anaerobic bacterial, OAC 310:667 OKLAHOMA STATE DEPARTMENT OF HEALTH 143 September 13, 2019 mycobacterial, and fungus cultures; and (vi) Drug and alcohol screening. (vii) For a hospital licensed as a general medical surgical hospital or specialty hospital, clinical laboratory services shall also comply with the applicable requirements in Subchapter 23 of this Chapter. (L) Respiratory therapy. Routine respiratory therapy procedures and mechanical ventilators shall be available twenty-four (24) hours a day. Respiratory therapy services shall comply with OAC 310:667-23-6. (M) Acute hemodialysis. The hospital shall have the capability to provide acute hemodialysis services twenty-four (24) hours a day. All staff providing hemodialysis patient care shall have documented hemodialysis training and experience. (N) Social services. Social services shall be available and provided as required in Subchapter 31 of this Chapter. (O) Burn Care. (i) The hospital shall 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 (ii) If the hospital does not meet the requirements at OAC 310:667-59-9(d)(1)(O)(i), it shall have a transfer agreement 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. (P) Spinal cord and head injury management. The hospital shall provide acute spinal cord and head injury management including at least the ability to initiate rehabilitative care prior to transfer and shall have a transfer agreement with a hospital that meets the requirements at OAC 310:667-59-9(d)(1)(P)(i) if comprehensive rehabilitation services are not available within the facility. (Q) Rehabilitation services. (i) The hospital shall 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 (ii) If the hospital does not meet the requirements at OAC 310:667-59-9(d)(1)(Q)(i) it shall have a transfer agreement with a hospital which meets the requirements of Subchapter 35 of this Chapter and is 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. (2) Personnel. (A) Trauma service director. The medical staff shall designate a surgeon as trauma service director. Through the quality improvement process, the director shall have responsibility for all trauma patients and administrative authority for the hospital's trauma program. The trauma service director shall be responsible for recommending appointment to and removal from the OAC 310:667 OKLAHOMA STATE DEPARTMENT OF HEALTH 144 September 13, 2019 trauma service. (B) Trauma coordinator. The hospital shall 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 shall have an active role in the following: (i) Clinical activities such as design of clinical protocols, monitoring care, and assisting the staff in problem solving; (ii) Educational activities such as professional staff development, case reviews, continuing education, and community trauma education and prevention programs; (iii) Quality improvement activities such as development of quality monitors, audits, and case reviews in all phases of trauma care; (iv) Administrative tasks for the trauma service such as those related to services' organization, personnel, budget preparation, and accountability; (v) Trauma registry data collection, coding, scoring, and validation; and (vi) Consultation and liaison to the medical staff, prehospital emergency medical service agencies, patient families, and the community at large. (C) Prevention coordinator. The hospital shall 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. (D) Emergency services director. The medical staff shall designate a physician credentialed to provide emergency medial care as emergency services director. (E) Surgical director. The medical staff shall designate a surgeon credentialed by the hospital to be the director of care for surgical and critical care for trauma patients. (F) Research director. The medical staff shall designate a physician as research director who may also serve as the trauma service director. The research director is responsible for the organization and management of the hospital's trauma and emergency operative research activities. (3) Supplies and equipment. (A) Emergency department. The emergency department shall have equipment for use in the resuscitation of patients of all ages on site, functional, and available in the emergency department, including at least the following: (i) Airway control and ventilation equipment, including laryngoscopes and endotracheal tubes of all sizes, bag-mask resuscitator, pocket masks, and oxygen; (ii) Pulse oximetry; (iii) End-tidal CO2 determination; (iv) Suction devices; OAC 310:667 OKLAHOMA STATE DEPARTMENT OF HEALTH 145 September 13, 2019 (v) Electrocardiograph-oscilloscope-defibrillator-pacer; (vi) Apparatus to establish central venous pressure monitoring; (vii) Standard intravenous fluids and administration devices, including large-bore intravenous catheters; (viii) Sterile surgical sets for: (I) Airway control/cricothyrotomy; (II) Thoracotomy; (III) Vascular access; and (IV) Chest decompression. (ix) Equipment for gastric decompression; (x) Drugs necessary for emergency care; (xi) Two-way communication with vehicles of emergency transport system as required at OAC 310:667-29-1(c)(4); (xii) Skeletal traction devices including cervical immobilization device; (xiii) Arterial catheters; and (xiv) Thermal control equipment for patients and infusion of blood, blood products, and other fluids. (B) Operating suite. The operating suite shall have the following supplies and equipment on site, functional and available for use: (i) Cardiopulmonary bypass capability; (ii) Operating microscope; (iii) Thermal control equipment for patients and infusion of blood, blood products, and other fluids; (iv) X-ray capability including c-arm intensifier; (v) Endoscopes; (vi) Craniotomy instruments; and (vii) Equipment appropriate for fixation of long-bone and pelvic fractures. (C) Post-anesthesia recovery unit. The post-anesthesia recovery unit shall have the following supplies and equipment on site, functional, and available for use: (i) Equipment for the continuous monitoring of temperature, hemodynamics, and gas exchange; (ii) Equipment for the continuous monitoring of intracranial pressure; (iii) Pulse oximetry; (iv) End-tidal CO2 determination; and (v) Thermal control equipment for patients and infusion of blood, blood products, and other fluids. (D) Intensive care unit. The intensive care unit shall have the following supplies and equipment on site, functional, and available for use: (i) Equipment for the continuous monitoring of temperature, hemodynamics, and gas exchange; (ii) Cardiopulmonary resuscitation cart; (iii) Electrocardiograph-oscilloscope-defibrillator-pacer; (iv) Sterile surgical sets for: (I) Airway control/cricothyrotomy; (II) Thoracotomy; (III) Vascular access; and OAC 310:667 OKLAHOMA STATE DEPARTMENT OF HEALTH 146 September 13, 2019 (IV) Chest decompression. (4) Policies on transfers. The hospital shall have written policies defining the medical conditions and circumstances for those emergency patients which may be retained for treatment in-house, and for those who require stabilizing treatment and transfer to another facility. (5) Quality Improvement. The hospital shall establish a multidisciplinary trauma 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 shall meet regularly to review and evaluate patient outcomes and the quality of care provided by the trauma service. In addition to any other requirements of this Chapter, the hospital quality improvement program shall include: (A) Trauma registry; (B) Audit for all trauma deaths to include prehospital care and care received at a transferring facility; (C) Morbidity and mortality review; (D) Medical nursing audit, utilization review, tissue review; (E) Regularly scheduled multidisciplinary trauma and emergency operative services review conference; (F) Published on call schedules for surgeons, neurosurgeons, and orthopedic surgeons; (G) Review of the times and reasons for trauma-related bypass; and (H) The availability and response times of on call staff specialists shall be defined in writing, documented, and continuously monitored. (I) Quality improvement staff with time dedicated to and specific for trauma and emergency operative services. (6) Continuing education. The hospital shall provide and document formal continuing education programs for physicians, nurses, allied health personnel, and community physicians. Continuing education programs shall be available to all state physicians, nurses, allied health personnel, and emergency medical service providers. (7) Organ Procurement. The hospital, in association with an organ procurement organization certified by CMS, shall develop policies and procedures to identify and refer potential organ donors. (8) Outreach programs. The hospital shall have organized outreach programs under the direction of a designated prevention coordinator. (A) Consultation. The hospital shall provide on-site and/or electronic consultations with community health care providers and those in outlying areas as requested and appropriate. (B) Prevention and public education programs. The hospital shall 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. (9) Research programs. The hospital shall have an organized trauma and emergency operative services research program under the direction of a designated research director. Research groups shall meet regularly and all research proposals shall be approved by an OAC 310:667 OKLAHOMA STATE DEPARTMENT OF HEALTH 147 September 13, 2019 Institutional Review Board (IRB) prior to launch. The research director shall maintain evidence of the productivity of the research program through documentation of presentations and copies of published articles. 310:667-59-10. [RESERVED] [Source: Reserved at 17 Ok Reg 2992, eff 7-13-2000]