44:68:01:01.  Definitions. Terms defined in SDCL 34-12-52 have the same meaning in this article. In addition, terms used in this section mean:

 

          (1)  "Advanced life support (ALS)," a level of prehospital and interhospital emergency care consisting of basic life support procedures and definitive therapy including the use of invasive procedures and may include the use of drugs and manual defibrillation;

 

          (2) "Advanced trauma life support (ATLS)," the advanced trauma life support course authorized by the American College of Surgeons -- Committee on Trauma;

 

          (3)  "Local emergency medical services transport plans (LEMSTP)," any plan developed by any emergency medical service, medical director, and hospital official which establish the most efficient method to transport trauma patients;

 

          (4)  "Trauma nursing core course (TNCC)," the trauma nursing core course authorized by the Emergency Nurses Association;

 

          (5)  "Trauma team," a group of health care professionals, designated by the local hospital, who provide care to the trauma patient; and

 

          (6)  "Trauma team alert patient," any patient that has injuries that require the activation of the local hospital trauma team.

 

          Source: 35 SDR 304, effective June 29, 2009.

          General Authority: SDCL 34-12-54.

          Law Implemented: SDCL 34-12-53, 34-12-54.

 

          44:68:02:02.  Level I, Level II, or Level III trauma hospital designation. Any hospital applying for Level I, Level II, or Level III trauma hospital designation shall present evidence of current trauma hospital verification from the American College of Surgeons. The department shall issue a certificate of designation with an expiration date consistent with the American College of Surgeons verification expiration date.

 

          Source: 35 SDR 304, effective June 29, 2009.

          General Authority: SDCL 34-12-54.

          Law Implemented: SDCL 34-12-53, 34-12-54.

 

          44:68:02:04.  Level VI hospital designation application. Level VI is limited to hospitals licensed pursuant to § 44:04:01:02. Any hospital seeking designation as a Level VI hospital shall submit an application to the department indicating the following:

 

          (1)  The type of healthcare services provided at the facility;

          (2)  That 24/7 registered nurse supervision is available, except for facilities with swing beds; and

          (3)  Transfer protocols are in place for trauma patients.

 

          Source: 35 SDR 304, effective June 29, 2009.

          General Authority: SDCL 34-12-54.

          Law Implemented: SDCL 34-12-53, 34-12-54.

 

          44:68:02:05.  Failure to maintain designation as a trauma hospital. A hospital that fails to maintain the criteria established pursuant to SDCL 34-12-52 to 34-12-55, inclusive, and this article shall submit a plan of correction to the department for approval. Once the plan is approved, the hospital shall complete the plan of correction within the timeframe outlined in the plan. The department may reinstate the trauma hospital as a designated trauma hospital upon completion of the plan of correction. Failure to follow an approved plan of correction or failure of a hospital to meet one of the six designation levels shall result in notification to the secretary of the department that the hospital has failed to comply with all applicable laws and regulations.

 

          Source: 35 SDR 304, effective June 29, 2009.

          General Authority: SDCL 34-12-54.

          Law Implemented: SDCL 34-12-53, 34-12-54.

 

          44:68:02:06.  Recognition of out-of-state trauma hospitals. The department may recognize any out-of-state hospital that has been designated as a trauma hospital pursuant to the applicable laws and regulations of the hospital's home state.

 

          Source: 35 SDR 304, effective June 29, 2009.

          General Authority: SDCL 34-12-54.

          Law Implemented: SDCL 34-12-53, 34-12-54.

 

          44:68:02:07.  Designation criteria for Level IV community trauma hospitals. A Level IV community trauma hospital shall meet the following criteria:

 

          (1)  The hospital organization shall have:

 

               (a)  A trauma program recognized by the hospital, including a physician medical director and trauma nurse leader;

               (b)  A hospital-specific definition of a trauma team alert patient;

               (c)  A multidisciplinary operational and performance improvement review committee with a defined purpose and meeting format. The committee may be combined with another performance improvement committee established by the hospital;

               (d)  Defined trauma team roles and responsibility;

               (e)  Defined trauma team activation guidelines; and

               (f)  Defined trauma transfer protocols;

 

          (2)  The hospital's medical capabilities shall include:

 

               (a)  Anesthesia services, which includes coverage by a licensed anesthesia provider pursuant to SDCL chapter 36-9A and SDCL chapter 36-4; and

               (b)  Trauma or general surgeon coverage to the emergency department at least 292 days each calendar year. If the trauma or general surgeon is on-call, the surgeon shall arrive within 30 minutes of patient arrival at least 85 percent of the time. The hospital shall have referral protocols in place for those times no surgeon is available;

 

          (3)  The hospital's emergency department shall include the following capabilities and equipment:

 

               (a)  Twenty-four hours a day, seven days a week operation;

               (b)  A designated medical director;

               (c)  Physician coverage of the emergency department for all trauma team activations 24 hours a day, seven days a week. If physician is on-call, the physician shall arrive within 15 minutes of patient arrival 85 percent of the time;

               (d)  A registered nurse available in the hospital and promptly available to the emergency department;

               (e)  Airway control and ventilation equipment including laryngoscope and endotracheal tubes of all sizes, other invasive airway adjuncts, bag-mask resuscitator, pocket masks, and oxygen;

               (f)  Pulse oximetry;

               (g)  End-tidal carbon dioxide detectors;

               (h)  Suction devices;

               (i)  Electrocardigraph-oscilloscope-defibrillator;

               (j)  Pediatric resuscitation equipment;

               (k)  Standard intravenous fluids and administration devices, including large bore intravenous catheters;

               (l)  Sterile surgical sets, including:

 

                      (i)    Airway control, cricothyrotomy, tracheostomy trays, or thoracotomy;

                      (ii)   Vascular access; and

                      (iii)  Needle decompression or chest tubes (various sizes);

 

               (m) Gastric decompression or nasal gastric tubes;

               (n)  X-ray availability 24 hours a day, seven days a week;

               (o)  Two-way communication with vehicles of emergency transport;

               (p)  Thermal control equipment for patients, as well as for blood and fluids; and

               (q)  Vascular Doppler;

 

          (4)  The hospital's surgical services shall include:

 

               (a)  An operating room team on-call with a maximum 30 minute response time, 85 percent of the time. The response time for the operating room team shall be documented and monitored;

               (b)  Thermal control equipment for patients, as well as for blood and fluids; and

               (c)  Rapid infuser system which may include pressure bags;

 

          (5)  The hospital's postanesthesia care unit services shall include:

 

               (a)  A registered nurse available 24 hours a day, seven days a week. On-call availability is acceptable. Times shall be documented and monitored;

               (b)  Pulse oximetry;

               (c)  End-tidal carbon dioxide detection; and

               (d)  Patient re-warming and thermal control monitoring;

 

          (6)  The hospital's intensive care unit services shall include:

 

               (a)  Trauma surgeon director or co-director;

               (b)  Pulse oximetry;

               (c)  End-tidal carbon dioxide detection; and

               (d)  Patient re-warming and thermal control monitoring;

 

          (7)  The hospital's radiology services shall include:

 

               (a)  A radiology technologist on-call with a maximum 30 minute response time. Response times shall be documented and monitored; and

               (b)  Conventional radiography;

 

          (8)  The hospital's laboratory services and capabilities shall include:

 

               (a)  A clinical laboratory available 24 hours a day, seven days a week;

               (b)  Standard analysis of blood, urine, and other body fluids;

               (c)  An O-negative blood supply;

               (d)  Coagulation studies; and

               (e)  Blood gas and pH determination;

 

          (9)  The hospital's support services shall include:

 

               (a)  Respiratory services; and

               (b)  Acute hemodialysis capability, either available on-site or via a transfer agreement;

 

          (10)  The hospital's trauma prevention and outreach shall include injury prevention and public awareness activities;

 

          (11)  The hospital's performance improvement and patient safety shall include:

 

               (a)  An organized and structured performance improvement program;

               (b)  A multidisciplinary performance improvement review committee. The committee may be combined with another performance improvement committee established by the hospital;

               (c)  The collection and submission of trauma data pursuant to chapter 44:68:04;

               (d)  A hospital and pre-hospital trauma care performance improvement review;

               (e)  A quarterly mortality and morbidity case review;

               (f)  An operation performance improvement review program including notification and arrival times for the following team members:

 

                      (i)    A trauma surgeon;

                      (ii)   An anesthesiologist or certified registered nurse anesthetist;

                      (iii)  A radiology technologist;

                      (iv)  A laboratory technician;

                      (v)   A surgery team;

                      (vi)  A post anesthesia recovery team; and

                      (vii) A respiratory therapist, if part of the trauma team;

 

               (g)  A published on-call schedule for trauma team members; and

               (h)  A collaborative involvement in pre-hospital care protocols; and

 

          (12)  The hospital's staff educational requirements shall be as follows:

 

               (a)  The physician medical director shall have current certification in ATLS education;

               (b)  The surgeon shall:

 

                      (i)    Have current certification in ATLS education; or

                      (ii)   Have documentation indicating successful completion of ATLS education at least once and a minimum of 16 hours of trauma continuing medical education credits every four years;

 

               (c)  The physician covering the emergency department shall:

 

                      (i)    Have current certification in ATLS education; or

                      (ii)   Have documentation indicating successful completion of ATLS education at least once and a minimum of 16 hours of trauma continuing medical education credits every four years;

 

               (d)  The physician assistant or nurse practitioner covering the emergency department shall:

 

                      (i)    Have current certification in ATLS education; or

                      (ii)   Have documentation indicating successful completion of ATLS education at least once and a minimum of 16 hours of trauma continuing medical education credits every four years;

 

               (e)  The trauma coordinator shall be current in TNCC education; and

               (f)  Each emergency department nurse shall be current in TNCC education.

 

          Source: 35 SDR 304, effective June 29, 2009.

          General Authority: SDCL 34-12-54.

          Law Implemented: SDCL 34-12-53, 34-12-54.

 

          44:68:02:08.  Designation criteria for Level V trauma receiving hospitals. A Level V trauma receiving hospital shall meet the following criteria:

 

          (1)  The hospital organization shall have:

 

               (a)  A trauma program recognized by the hospital, including a physician medical director and trauma nurse leader;

               (b)  A hospital-specific definition of a trauma team alert patient;

               (c)  A multidisciplinary operational and performance improvement review committee with a defined purpose and meeting format. The committee may be combined with another performance improvement committee established by the hospital;

               (d)  Defined trauma team roles and responsibility;

               (e)  Defined trauma team activation guidelines; and

               (f)  Defined trauma transfer protocols;

 

          (2)  The hospital's emergency department shall include the following capabilities and equipment:

 

               (a)  Twenty-four hours a day, seven days a week operation;

               (b)  A designated medical director;

               (c)  Physician, physician assistant, or nurse practitioner on-call coverage with a maximum 30 minute response time. Response time shall be documented and monitored;

               (d)  A registered nurse available in the hospital and promptly available to the emergency department;

               (e)  Airway control and ventilation equipment including laryngoscope and endotracheal tubes of all sizes, other invasive airway adjuncts, bag-mask resuscitator, pocket masks, and oxygen;

               (f)  Pulse oximetry;

               (g)  End-tidal carbon dioxide detectors;

               (h)  Suction devices;

               (i)   Electrocardiograph-oscilloscope-defibrillator;

               (j)   Pediatric resuscitation equipment;

               (k)  Standard intravenous fluids and administration devices, including large bore intravenous catheters;

               (l)  Sterile surgical sets, including:

 

                      (i)    Airway control, cricothyrotomy, tracheostomy trays, or thoracotomy;

                      (ii)   Vascular access; and

                      (iii)  Needle decompression or chest tubes (various sizes);

 

               (m)  Gastric decompression or nasal gastric tubes;

               (n)   X-ray availability 24 hours a day, seven days a week;

               (o)   Two-way communication with vehicles of emergency transport;

               (p)   Thermal control equipment for patients; and

               (q)   Vascular Doppler;

 

          (3)  The hospital's radiology services shall include:

 

               (a)  A radiology technologist on-call with a maximum 30 minute response time. Response times shall be documented and monitored; and

               (b)  Conventional radiography;

 

          (4)  The hospital's laboratory services and capabilities shall include:

 

               (a)  A clinical laboratory available 24 hours a day, seven days a week;

               (b)  Standard analysis of blood, urine, and other body fluids;

               (c)  An O-negative blood supply; and

               (d)  Coagulation studies;

 

          (5)  The hospital shall have respiratory services available;

 

          (6)  The hospital's trauma prevention and outreach shall include injury prevention and public awareness activities;

 

          (7)  The hospital's performance improvement and patient safety shall include:

 

               (a)  An organized and structured performance improvement program;

               (b)  A multidisciplinary performance improvement review committee. The committee may be combined with another performance improvement committee established by the hospital;

               (c)  The collection and submission of trauma data pursuant to chapter 44:68:04;

               (d)  A hospital and pre-hospital trauma care performance improvement review;

               (e)  A quarterly mortality and morbidity case review;

               (f)  An operation performance improvement review program including notification and arrival times for the following team members:

 

                      (i)    An on-call physician, physician assistant, or nurse practitioner;

                      (ii)   A radiology technologist;

                      (iii)  A laboratory technician; and

                      (iv)  A respiratory therapist, if part of the trauma team;

 

               (g)  A published on-call schedule for trauma team members; and

               (h)  A collaborative involvement in pre-hospital care protocols; and

 

          (8)  The hospital's staff educational requirements shall be as follows:

 

               (a)  The physician medical director shall have current certification in ATLS education;

               (b)  The surgeon, if on staff, shall:

 

                      (i)    Have current certification in ATLS education; or

                      (ii)   Have documentation indicating successful completion of ATLS education at least once and a minimum of 16 hours of trauma continuing medical education credits every four years;

 

               (c)  The physician covering the emergency department shall:

 

                      (i)    Have current certification in ATLS education; or

                      (ii)   Have documentation indicating successful completion of ATLS education at least once and a minimum of 16 hours of trauma continuing medical education credits every four years;

 

               (d)  The physician assistant or nurse practitioner covering the emergency department shall:

 

                      (i)    Have current certification in ATLS education; or

                      (ii)   Have documentation indicating successful completion of ATLS education at least once and a minimum of 16 hours of trauma continuing medical education credits every four years; and

 

               (e)  Each emergency department nurse shall be current in TNCC education.

 

          Source: 35 SDR 304, effective June 29, 2009.

          General Authority: SDCL 34-12-54.

          Law Implemented: SDCL 34-12-53, 34-12-54.

 

          44:68:03:01.  Local emergency medical services transport plan. Each emergency medical service shall develop and implement a local emergency medical service transport plan for the transport of trauma team alert patients. The LEMSTP shall be approved by each participating health care entity named in the plan and the medical director of the emergency medical service. The final LEMSTP shall be submitted to the department for approval. The LEMSTP shall be updated and submitted to the department at least every five years, and if the LEMSTP is revised.

 

          Source: 35 SDR 304, effective June 29, 2009.

          General Authority: SDCL 34-12-54.

          Law Implemented: SDCL 34-12-53, 34-12-54.

 

          44:68:03:03.  Triage. Each emergency medical service shall adopt triage guidelines that include processes for identifying patients based on severity of injury and for prioritizing patients for treatment and transport. These guidelines shall be used for any event that places significant demand on local resources, be it equipment or personnel.

 

          Source: 35 SDR 304, effective June 29, 2009.

          General Authority: SDCL 34-12-54.

          Law Implemented: SDCL 34-12-53, 34-12-54.

 

          44:68:04:01.  Reporting. The department shall establish a trauma registry. Level I, II, III, IV, and V trauma hospitals shall report to the department regarding any patient that meets the local hospital criteria for trauma team activation, or any patient that has a hospital admission of greater than 48 hours with at least one injury, an International Classification of Diseases, 9^th revision ICD-9 diagnosis code between 800.00 and 959.9, including 940-949 (burns), excluding 905-909 (late effects of injuries), 910-924 (blisters, contusions, abrasions, and insect bites), 930-939 (foreign bodies), and isolated hip fractures resulting from a same level fall unrelated to a traumatic event, and also meet at least one of the following criteria:

 

          (1)  The patient's outcome was death due to trauma;

          (2)  The patient was admitted to the intensive care unit and/or operating room; or

          (3)  The patient was transferred either into or out of the hospital.

 

          Reporting may occur electronically, through completion of the paper form, or another method approved by the department.

 

          Source: 35 SDR 304, effective June 29, 2009.

          General Authority: SDCL 34-12-54.

          Law Implemented: SDCL 34-12-53, 34-12-54.

 

          Reference: International Classification of Diseases, 9^th revision, 2009. Copies may be obtained from Ingenix, PO Box 27116, Salt Lake City, UT 84127-0116. Cost: $94.95 or order online at

http://www.shopingenix.com/modules/catalog/catalog_product.asp?ProductID=28934&CategoryID=100093&MarketType=.

 

          44:68:04:02.  Confidentiality of trauma registry data. Any report required to be submitted to the statewide trauma registry is strictly confidential medical information. No report may be released, shared with any agency or institution, or made public, upon subpoena, search warrant, discovery proceedings, or otherwise. No report is admissible as evidence in any action of any kind in any court or before any tribunal, board, agency, or person. However, the department may release data for statistical purposes in such a manner that no person, hospital, or emergency medical service can be identified.

 

          Source: 35 SDR 304, effective June 29, 2009.

          General Authority: SDCL 34-12-54.

          Law Implemented: SDCL 34-12-53, 34-12-54.