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Delaware General AssemblyDelaware RegulationsMonthly Register of RegulationsNovember 2013

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16 DE Admin. Code 4305
On September 1, 2013 (Volume 17, Issue 3), DHSS published in the Delaware Register of Regulations its notice of proposed regulations, pursuant to 29 Del.C. §10115. It requested that written materials and suggestions from the public concerning the proposed regulations be delivered to DHSS by October 3, 2013, after which time the DHSS would review information, factual evidence and public comment to the said proposed regulations.
First, §5.2.2.4 recites as follows:
Agency Response: The Agency appreciates and acknowledges these comments. We will add the date of promulgation of the original regulations, 2001, to clarify this Note. 5.2.2.4 is Essential in the current regulations and is not proposed to be changed. Desirable refers to 5.2.2.3 directly above 5.2.2.4, and the classification as Essential follows 5.2.2.4.
Second, §5.2.4 consists of an outline/list of “essential” participating hospital criteria. It would benefit from an introductory narrative. For example, the introduction could simply recite as follows: “Trauma System Participating Hospitals must have the following in place:”
Agency Response: The Agency appreciates and acknowledges these comments. The terms Essential and Desirable are taken from the format of the American College of Surgeons Committee on Trauma’s document “Resources for Optimal Care of the Injured Patient” which Delaware utilizes for all Levels 1, 2, and 3 Trauma Center standards and site visits. This section was formatted to be in alignment with the national document.
Third, in §7.7.1.1, the former standards contemplated patient inclusion in the hospital Trauma Registry based on “admission”. The new standards literally only authorize inclusion of patients in the Registry based on a “transfer”. It may be preferable to include patients in the Registry who are directly admitted to a trauma center without being “transferred” from another facility.
Agency Response: The Agency appreciates and acknowledges these comments. 7.7.1.1.1 states admission to the hospital. The transfer criteria are items 7.7.1.1.2 and 7.7.1.1.3.
“ACLS” The Advanced Cardiac Life Support Course of the American Heart Association.
“Attending” A physician with practice privileges delineated by the hospital's medical staff.
“ATLS” The Advanced Trauma Life Support Course of the American College of Surgeons.
“Board Certified” A physician certified by an appropriate specialty board recognized by the American Board of Medical Specialties or the American Osteopathic Association.
“Bypass” A request by a hospital to an Emergency Medical Service that patient (s) be directed to another hospital's Emergency Department due to a shortage or unavailability of beds, equipment, personnel, or other essential resource.
“Minor injuries” Those patients with an Injury Severity Score less than 9.
“Moderate injuries” Those patients with an Injury Severity Score between 9 and 15.
“Major (severe) injuries” Those patients with an Injury Severity Score greater than 15.
Community Trauma Center” An acute care hospital that provides assessment, resuscitation, stabilization, and triage of all trauma patients, arranging for timely transfer of those patients requiring the additional resources of a Regional Trauma or Specialty Center and delivering definitive care to those whose needs match the resources of the Community Trauma Center.
“Continuing Medical Education (CME) Credit” Educational hours for physicians approved by the Accreditation Council of Continuing Medical Education or an agency recognized by this council.
“Credentialing Process” A hospital's procedure for granting practice privileges to healthcare providers.
"D" Desirable requirement for trauma facilities; encouraged but not required for designation.
Dedicated” A resource used solely for a specific program.
Definitive Care” A level of medical intervention capable of providing comprehensive services for a patient's injuries and associated conditions.
Demonstrated Commitment” Provision of evidence (visible and written) that demonstrates clearly an institution-wide commitment to trauma care.
Designation” A process through which a hospital is confirmed by the Division of Public Health to have the appropriate resources to manage patients with injuries of particular degrees of severity, and is granted the authorization to function as a Delaware Trauma Center.
"E" Essential requirement for trauma facilities.
EMS” Emergency Medical Services. The arrangement of personnel, facilities, equipment, transportation, and communication to provide for the effective and coordinated delivery of medical care in emergency situations resulting from accidents, illnesses, or natural disasters.
Hospital Trauma Quality Management Program” The review program within each Trauma Center which monitors such aspects of the Trauma Program as adherence to policies and patient outcome with the goal of assuring that optimal care is continuously provided.
“Immediately Available” This implies the physical presence of a resource in a stated location at the time it is needed by the trauma patient.
“Inclusive Trauma Care System” A Trauma Care System which incorporates every acute care facility in the defined region into a system in order to provide a continuum of services for all injured persons who require medical care; in such a system, the injured patient's needs are matched to the appropriate hospital resources.
“In-house” Physically present in the hospital.
“Injury Control” Methodologies designed for the purpose of preventing and eliminating injuries.
“Injury Severity Score (ISS)” A retrospective summary score derived by applying a prescribed scoring system and mathematical formula to a listing of a trauma patient's injuries. Use of this scoring system allows objective comparisons of trauma patients based on their injuries.
“Interfacility Transfer” The transfer of a patient from one hospital to another hospital.
Interpretations to Standards” Information issued by the Division of Public Health defining acceptable methods for hospitals to demonstrate compliance with the Trauma Center Standards.
“n/a” A standard which is not applicable to a particular level of trauma facility or participating hospital.
“On-call” Committed for a specific time period to be available and respond within an agreed amount of time to provide care for a patient in the hospital.
“PALS” The Pediatric Advanced Life Support Course of the American Heart Association.
“Participating Hospital” An acute care facility which transfers trauma patients with moderate or severe injuries to Trauma Centers after initial resuscitation. When necessary, this facility may provide care to trauma patients with minor injuries. Participating hospitals contribute data to the Delaware Trauma System Registry and Quality Improvement Program.
“Pediatric Specialists” Certified pediatric specialists with a commitment to trauma or certified general practitioners with special training, experience, and continuing education relevant to pediatric trauma care.
“Pediatric Trauma Centers” Children's hospitals which meet the standards for a particular classification of Trauma Center within Delaware's Pediatric Trauma Standards and the corresponding classification in Delaware's Adult Trauma Standards.
“Prevention” Efforts to decrease the numbers and severity of traumatic injuries.
“Promptly Available” Implies the physical presence of health professionals in a stated location within a short period of time, which is defined by the Trauma Director, incorporated into the written protocols of the Trauma Service, and continuously monitored by the Quality Improvement Program.
“Protocols” Written standards for clinical practice in a variety of situations within the Trauma System.
“Regional Level 1 Trauma Center” A regional resource Trauma Center that has the capability of providing leadership and comprehensive, definitive care for every aspect of injury from prevention through rehabilitation.
“Regional Level 2 Trauma Center” A regional Trauma Center with the capability to provide initial care for all trauma patients. Most patients would continue to be cared for in this Center; there may be some complex cases which would require transfer for the depth of services of a Regional Level 1 or Specialty Center.
“Response Time” Time interval between notification and arrival of the general surgeon or surgical specialist in the Emergency Department or Operating Room.
“Transfer Agreement” A formal written agreement between hospitals which provides for the acceptance of patients in transfer.
“Trauma” A term derived from the Greek for "wound", it refers to any bodily injury. Injury is the result of an act that damages, harms, or hurts; unintentional or intentional damage to the body resulting from acute exposure to mechanical, thermal, electrical, or chemical energy or from the absence of such essentials as heat or oxygen.
“Trauma Center” A specialized hospital distinguished by the immediate availability of specialized surgeons, physician specialists, anesthesiologists, nurses, and resuscitation and life support equipment on a 24-hour basis to care for severely injured patients or those at risk for severe injury.
Trauma Facility” An acute care hospital which has received and maintains current State designation as a Trauma Center.
“Trauma Registry” A data base to provide information for analysis and evaluation of the quality of patient care, including epidemiological and demographic characteristics of trauma patients. The 'Expanded' data set provides a basis for the hospital's Trauma Quality Program; the 'Minimal' data set collects largely demographic information.
“Trauma System Quality Management Program” The program which reviews aspects of the Trauma System such as interfacility transfers and triage decisions with the goal of assuring that the various components of the Trauma Care System are functioning optimally.
“Trauma Team” A team approach is required for the optimal care of patients with multiple-system injuries. The composition of the trauma team and roles of the members are to be defined by the Trauma Director. The Trauma Surgeon Team Leader is responsible for overseeing and coordinating the operation of the Trauma Team to provide optimal patient care throughout hospitalization.
“Triage” The sorting of patients in terms of priority need for care, so that appropriate treatment, transportation, and destination decisions can be made according to predetermined protocols.
“Verification” A process in which the trauma care capability and performance of an institution are evaluated by experienced on-site reviewers.
4.1.1.2 Make Assist with making verification visit arrangements with the American College of Surgeons (ACS) upon hospital request.
4.1.2 Contract Work with American College of Surgeons for verification visits
4.1.2.1.3.1 2 Trauma Surgeons
4.1.2.1.3.2 1 trauma RN
1 Neurosurgeon
4.1.2.1.3.3 1 E.M. Emergency Medicine physician
4.1.2.1.4.1 2 Trauma Surgeons
4.1.2.1.4.2 1 E. M. Emergency Medicine physician
4.1.2.1.5.1 Division of Public Health designees
4.1.2.2.1 ACS administrative costs decrease when multiple hospitals within one state are visited during the same time period.
4.1.2.2.2 It will be the individual hospital's decision as to when it is adequately prepared to begin the verification process. The Division of Public Health will hold periodic designation cycles for hospitals to apply for Trauma Center status designation.
4.1.2.4.1 The ACS requires a detailed application form. This form will be supplied to requesting hospitals by the Division of Public Health and forwarded to the ACS by the Division upon receipt of the completed applications. A completed ACS application must be submitted to ACS and the Division of Public Health by the hospital.
4.1.2.5 Note: iIn any case where the American College of Surgeons does not provide the scope necessary to include a particular hospital in its verification process, the Director of the Division of Public Health may decide to allow that hospital to participate in the Delaware Trauma System under special circumstances. In this case, that hospital is encouraged to utilize the ACS to the extent to which applicable services are available, and the Division will arrange for a comparable verification visit by national trauma experts under individual contract with the Division. Fees and site visit reports of this team will be handled in the same manner as those of the ACS.
4.2.1.1 Association of Delaware Hospitals Delaware Healthcare Association
4.2.1.4 Delaware Medical Society Medical Society of Delaware (request an anesthesiologist or intensivist)
4.2.1.7 Delaware Emergency Nurse Association and Critical Care Nurse Association
4.2.1.8 Delaware Orthopedic Surgeon Society of Orthopedic Surgeons
4.2.2 The Director will appoint nine committee members who will provide geographic and institutional diversity from the nominations received for initial terms of one (three members), two (three members), or three (three members) years. Terms thereafter will be three years; committee members may be invited to serve up to two subsequent terms providing the Committee's diversity is maintained. Members will serve at the pleasure of the Director of Public Health, until they submit a letter of resignation, their organization requests to replace them, or they are absent from meetings for a period of one year, which will be cause for dismissal.
4.2.5 The ACS report on all verification visits will be received by the Division of Public Health, which will forward the information to the Trauma Center Designation Committee. The Designation Committee will make recommendations to the Division on the category of Trauma Center designation for which each hospital has qualified, based on its review of the ACS site visit report and application of Delaware's correlational template. Any hospital not receiving the full ACS verification will be offered the opportunity for a representative to address the Designation Committee for no more than ten minutes prior to their deliberation. The Division Director will then designate the state's Trauma Centers based on these recommendations.
4.4.1 ACS reverification visits will must be scheduled by the Division of Public Health every three years for those hospitals wishing to continue their Trauma Center status.
5.1.4 Copies of the current American College of Surgeons’ Resources for Optimal Care of the Injured Patient:1999 may be obtained by contacting the American College of Surgeons’ Publication Orders Department at 633 N. Saint Clair Street in Chicago, IL, 60611 or by telephone at (312) 202-5000.
5.1.4.1 Additionally, The Office of Emergency Medical Services (Blue Hen Corporate Center Suite 4H, Dover (302) 739-6637 100 Sunnyside Road, Smyrna, DE. 19977, (302)223-1350) and Division of Public Health Director’s Office (Jesse Cooper Building, Dover, (302) 739-4701) will each have a copy of this document available on site for public reference.
5.2.1.1 Trauma surgeons, neurosurgeons, and orthopedic surgeons must be dedicated to one hospital when on call (taking call at only one institution at a time) or there must be a physician on back-up call at each institution he/she is covering.
Essential
5.2.2.1 Trauma surgeons medical directors and physician liaisons to the trauma program from, neurosurgeonsry, Emergency Medicine department physicians, and orthopedics surgeons must obtain 16 hours of verifiable, external trauma or trauma-related Continuing Medical Education credits per year, or 48 hours in 3 years.
Essential
5.2.2.2 Other trauma surgeons who take trauma call must have the documented 16 hours annually or 48 hours in 3 years of trauma-related CME or participate in an internal educational process conducted by the trauma program based on the principles of practice-based learning and the PIPS program.
Essential
5.2.2.3 Other neurosurgery, Emergency Medicine, and orthopedic physicians who take trauma call must have the documented 16 hours annually or 48 hours in 3 years of trauma-related CME or participate in an internal educational process conducted by the trauma program based on the principles of practice-based learning and the PIPS program.
Desirable
5.2.2.24 Emergency Medicine department physicians, orthopedic surgeons, and neurosurgeons taking trauma call must be Board certified or eligible.
Essential
5.2.3.1 Board certified or board eligible attending radiologists with privileges in diagnostic radiology are available 24/7, in person or by teleradiology, for the interpretation of radiographs, performance of complex imaging studies, and interventional procedures.
Essential
Prehospital Trauma Triage Scheme Implementation Guidelines Due to the dynamic nature of identification and evolution of best practices in prehospital care, the prehospital trauma triage guidance will be found solely in the current State of Delaware, Department of Health and Social Services, Division of Public Health, Office of Emergency Medical Services, Statewide Standard Treatment Protocols, Guidelines, Policies, and Paramedic Standing Orders and Statewide Standard Treatment Protocols and Basic Life Support Standing Orders. The Trauma System Committee will [be] ask[ed] for input by the State EMS Medical Director through the Trauma System Manager during every Standing Orders revision process.
6.1.1 The Triage Scheme is designed to serve as a tool for the prehospital provider to use in a step-by-step manner in order to arrive at appropriate triage decisions for trauma patients. Based on the American College of Surgeons' Committee on Trauma's Resources for Optimal Care of the Injured Patient:1993 and the American College of Emergency Physicians' Guidelines for Trauma Care Systems, it is laid out to follow the logical progression of assessment used when responding to a trauma call. Step 1 takes place as the responder approaches the scene and notes mechanism of injury, followed by the notation of obvious injuries (Step 2) observed as the provider approaches the patient. Step 3 criteria are vital sign parameters.
6.1.7 Major burns (STEP 2) are defined as:
6.112 In order to be considered a participant in Delaware's Prehospital Trauma System Triage Scheme, an out-of-state facility must receive Delaware reciprocity as a Trauma Center by demonstrating current Trauma Center designation status and adherence to equivalent trauma standards.
Utilization of aeromedical services has become a nationally accepted standard for the rapid evacuation and transportation of critically injured patients to the most appropriate medical facility for definitive medical care. In order to make the best decisions about the most appropriate mode of transport for a particular patient, multiple factors must be considered. Clinical factors relate to the patient and are described in the Prehospital Trauma Triage Scheme, Steps 1, 2, and 3 Delaware Paramedic and Basic Life Support Standing Orders. Operational factors relate to the transport process, and include helicopter availability and location measured against ground transport time. Weather, traffic, ground unit availability, and scene accessibility are other operational factors which must be considered on a case by case basis.
Air transport is appropriate for a seriously injured trauma patient (see Prehospital Trauma Triage Scheme, Steps 1, 2, 3 Delaware Paramedic and Basic Life Support Standing Orders) when ground transport time to a Trauma Center will exceed 10 minutes. To avoid excessive time spent on scene awaiting arrival of the aircraft, the helicopter should be dispatched at the time of initial ALS dispatch or immediately upon arrival of the first units on scene. It is in the patient's best interest for the aircraft to be dispatched early rather than to wait for ground unit request when available information suggests a major incident. When appropriate, consideration may be given to rendezvous.
If transport time between two Trauma Centers is relatively equal, critically injured trauma patients should be transported directly to the higher level Trauma Center. Patients with significant head trauma as evidenced by a Glasgow Coma Score of 8 or less, or spinal cord trauma as evidenced by new onset limb paralysis or weakness should be transported directly to a Level 1 or Level 2 Trauma Center with an available neurosurgeon when possible. Availability of air transport will impact these time and distance decisions and may potentially save the patient the time required for later interfacility transfer as well as keep the helicopter available for scene medevac work.
Carotid or vertebral arterial injury
Glasgow Coma Scale (GCS) <1214 or GCS deterioration
Major chest wall injury (penetrating injuries to torso, flail chest)
Wide mediastinum or other signs suggesting thoracic aorta or other great vessel injury
Cardiac rupture or other cardiac injury
Bilateral pulmonary contusion with PaO2 to FiO2 ratio < 200 >2 unilateral rib
fractures, bilateral rib fractures with pulmonary contusion, or other Ppatients who may require mechanical
Significant torso injury with advanced comorbid disease (see Comorbid Factors below)
Major abdominal vascular injury
Complex Oopen or multiple long-bone fractures
Major burns *, burns with associated injuries
Comorbid Factors (not stand alone criteria but should increase index of suspicion):
Age<1215 or>55 years
6.4.1 Major burns which usually require early referral to a Burn Center include the following:
6.4.1.1 3rd degree burns involving more than 5% Body Surface Area (BSA) in all ages,
6.4.1.2 2nd or 3rd degree burns involving more than 10% BSA in patients younger than 10 years or older than 50 years of age of all ages,
2nd or 3rd degree burns involving more than 20% BSA in all ages,
6.4.1.3 2nd or 3rd degree bBurns involving face, hands, feet, genitalia, perineum, or major joints in all ages,
6.4.1.4 Significant eElectrical burns including lightening injury in all ages,
6.4.1.5 Significant cChemical burns in all ages,
6.4.1.6 Inhalation injury in all ages,
6.4.1.7 Burn injury in patients with pre-existing illnesses medical disorders that could complicate management, prolong recovery, or affect mortality, and
6.4.1.8 Burn injury in patients who will require special social, emotional, or long-term rehabilitative support, including cases involving suspected child abuse and neglect, intervention,
The State of Delaware Trauma System is committed to provision of optimal care for all injured persons. In order to attain this goal, the Division of Public Health coordinates all medical services provided to trauma patients based on national standards for trauma care as set forth by the Joint Commission on Accreditation of Health Care Organizations (JCAHO), the American College of Surgeons Committee on Trauma (ACS/COT)’s Resources for Optimal Care of the Injured Patient: 1993, the American College of Emergency Physicians (ACEP)’s Trauma Care System Guidelines, 1992 and Health Resources and Services Administration’s The Model Trauma Care System Plan, 1992 and subsequent revisions of these documents. This Performance Improvement Plan seeks to enable this System to meet and exceed these standards, both administratively and clinically, through promotion and achievement of continuous improvement in all aspects of the statewide trauma program’s organization and associated activities.
7.3.1 Based on national standards for Facility Quality Improvement set forth in the American College of Surgeon’s Resources for Optimal Care of the Injured Patient (1993) and the JCAHO Recommendations for Improving Organizational Performance and for System Quality Improvement as outlined in the American College of Emergency Physician’s Trauma Care System Guidelines, 1992, the Trauma System’s Quality Improvement Plan describes the framework for use in designing, measuring, assessing, and improving the Delaware Trauma System’s organization, functions, and services. This is accomplished by a collaborative approach with the appropriate facilities, services, and disciplines involved, utilizing the following objectives:
The Division of Public Health shall work with the Fire Prevention Commission to address improvements regarding pre-hospital care of the injured patient. The American College of Emergency Physicians' Trauma Care System Guidelines will provide a basis for pre-hospital trauma care evaluation. There will be an on-going evaluation of all aspects of trauma care from the receipt of the call at central dispatch to the patient’s arrival at the medical facility. Evaluation will document quality of care provided and compliance with protocols. Areas in need of improvement will be identified. Major areas of review are as follows:
A completed pre-hospital patient care record must be provided to the medical receiving facility for inclusion in the patient’s emergency room or hospital medical record. Facilities and pre-hospital providers are strongly encouraged to establish a mechanism for exchange of information, including provision of feedback to prehospital providers on triage decisions made. Additionally, the hospital’s Trauma Registrar will include this record’s data in the facility’s Trauma Registry for outcome evaluation.
7.6.1 All designated trauma facilities will design a performance improvement plan which meets the standards and requirements established by the Division of Public Health. The Division shall utilize as guidelines the American College of Surgeons' Resources for Optimal Care of the Injured Patient: 1993 standards and subsequent revisions (as described in Chapter 6, Section D, page 32, and Chapter 16, pages 77-83). Hospital performance improvement plans will be verified during site survey and quality improvement visits.
7.7.1.1.1 admission to the hospital for greater than 2 calendar days, or
7.7.1.1.42 transfer to a trauma center or acute care facility, or
7.7.1.1.53 transfer from an acute care facility, or
7.7.1.1.64 death, including Emergency Department deaths and patients who are dead on arrival.
7.7.1.2 Exclusion: Patients over 55 years having the solitary diagnosis of closed fracture of neck of femur, ICD-9 CM N 820.0 or 820.2 AND underlying cause of injury defined by E884.2, E885, or E888 (falls on same level, from bed or chair, other falls). INCLUSIONS:
7.8.2.1 Implement and monitor the State Trauma System Quality Improvement Program.
7.8.3 Trauma System Registry Coordinator Responsibilities
7.8.4.2 Membership consists of representatives from each component of the statewide Trauma System. The Trauma System Medical Advisor will serve as Trauma System Quality Evaluation Committee Chairperson.
The Delaware Trauma System Quality Evaluation Committee is charged with providing recommendations, advice, and assistance to the Division of Public Health in its ongoing evaluation of the Delaware Trauma System based on American College of Emergency Physicians standards and nationally accepted Continuous Quality Improvement guidelines. Specific functions may include the following:
7.8.4.3.1 Assist the Trauma System Registry Coordinator in the supervision of the State Trauma Registry.
8.1 American College of Emergency Physicians: Guidelines for Trauma Care Systems. Dallas, Texas, ACEP, 1992.
8.2 American College of Surgeons Committee on Trauma: Resources for Optimal Care of the Injured Patient:1993. Chicago, Illinois, ACS, 1993.
8.3 U.S. Department of Health and Human Services: Model Trauma Care System Plan. Rockville, Maryland, DHSS, 1992.
Last Updated: December 31 1969 19:00:00.
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