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<chapter num="08" heading="Pediatric Trauma Center Standards" title_num="30" subtitle_num="08">
  <regulation prefix="Regulation" num=".01" heading="Definitions.">
    <paragraph num="A.">
      <text>In this chapter, the following term has the meaning indicated.</text>
    </paragraph>
    <paragraph num="B.">
      <text>Term Defined. “Level I pediatric trauma center (level I PTC)” means a hospital that is capable of and committed to providing comprehensive pediatric trauma care to children younger than 15 years old, meets the standards of this chapter, and is an:</text>
      <paragraph num="(1)">
        <text>In-State hospital designated by MIEMSS and approved by the EMS Board to provide comprehensive pediatric trauma care services; or</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Out-of-State hospital that has entered into an agreement with MIEMSS and been approved by the EMS Board to provide comprehensive pediatric trauma services to Maryland patients.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".02" heading="Organization.">
    <paragraph num="A.">
      <text>The hospital's board of directors, administrators, and medical and nursing staffs shall demonstrate commitment to the optimal care of injured pediatric patients by:</text>
      <paragraph num="(1)">
        <text>Formulating a board of director's resolution stating that:</text>
        <paragraph num="(a)">
          <text>The hospital agrees to meet the Maryland Pediatric Trauma Center designation standards; and</text>
        </paragraph>
        <paragraph num="(b)">
          <text>The hospital has a commitment to the infrastructure and the financial, human, and physical resources necessary to support the hospital’s designation as a pediatric trauma center;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(2)">
        <text>Establishing an identifiable organization whose dedication to the care of injured children is shown in:</text>
        <paragraph num="(a)">
          <text>Its mission statement;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>The configuration of its medical, administrative, and support staffs; and</text>
        </paragraph>
        <paragraph num="(c)">
          <text>The configuration of its physical plant;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(3)">
        <text>Participating in the Statewide trauma system, including submission of patient care data to the State Trauma Registry for system and quality management (QM);</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Assuring that all pediatric trauma patients shall receive medical care commensurate with the hospital's designation as a pediatric trauma center; and</text>
      </paragraph>
      <paragraph num="(5)">
        <text>A board of director's resolution, bylaws, contracts, and budgets, all specific to the pediatric trauma center, indicating the hospital's commitment to the financial, human, and physical resource infrastructure that is necessary to support the hospital's designation as a pediatric trauma center.</text>
      </paragraph>
    </paragraph>
    <paragraph num="B.">
      <text>The hospital shall:</text>
      <paragraph num="(1)">
        <text>Be licensed as an acute care hospital by the Maryland Department of Health or, if located outside Maryland, in the state in which it is located;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Be accredited by an organization that has been granted deeming authority by the Centers for Medicare &amp; Medicaid Services and approved by the Maryland Department of Health to accredit hospitals in the State;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Maintain current equipment and technology to support optimal pediatric trauma care;</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Admit annually 200 or more injured children who are younger than 15 years old;</text>
      </paragraph>
      <paragraph num="(5)">
        <text>Have the ability to treat effectively all types of pediatric injuries, including:</text>
        <paragraph num="(a)">
          <text>Brain injury;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Spinal cord injury;</text>
        </paragraph>
        <paragraph num="(c)">
          <text>Solid organ injury;</text>
        </paragraph>
        <paragraph num="(d)">
          <text>Chest injury;</text>
        </paragraph>
        <paragraph num="(e)">
          <text>Complex musculoskeletal injury;</text>
        </paragraph>
        <paragraph num="(f)">
          <text>Burns;</text>
        </paragraph>
        <paragraph num="(g)">
          <text>Eye injury;</text>
        </paragraph>
        <paragraph num="(h)">
          <text>Hand and upper extremity injury; and</text>
        </paragraph>
        <paragraph num="(i)">
          <text>Lower extremity injury; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(6)">
        <text>Have a heliport or helipad positioned at the closest safe location so there is a limited distance from the helipad to the hospital.</text>
      </paragraph>
    </paragraph>
    <paragraph num="C.">
      <text>The pediatric trauma center shall have a pediatric trauma leadership team responsible for monitoring and coordinating all components of the pediatric trauma program, including:</text>
      <paragraph num="(1)">
        <text>A pediatric trauma medical director (TMD) who:</text>
        <paragraph num="(a)">
          <text>Is a board-certified pediatric surgeon;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Demonstrates expertise and commitment to the care of injured children;</text>
        </paragraph>
        <paragraph num="(c)">
          <text>With the trauma program manager (TPM), is empowered by the hospital’s governing body to lead the pediatric trauma center;</text>
        </paragraph>
        <paragraph num="(d)">
          <text>Has the authority and scope for administering all aspects of trauma care and is responsible for the overall clinical coordination of the pediatric trauma center;</text>
        </paragraph>
        <paragraph num="(e)">
          <text>Has the responsibility for the oversight of the QM process related to all pediatric trauma patients;</text>
        </paragraph>
        <paragraph num="(f)">
          <text>Participates in and publishes pediatric trauma research;</text>
        </paragraph>
        <paragraph num="(g)">
          <text>Has a job description developed by the hospital to reflect the role and responsibilities as defined by COMAR;</text>
        </paragraph>
        <paragraph num="(h)">
          <text>Appears on the hospital’s organizational chart where the relationship between the TMD and other hospital services are depicted and delineated;</text>
        </paragraph>
        <paragraph num="(i)">
          <text>Participates in local, regional, state and national activities related to pediatric injury care and prevention; and</text>
        </paragraph>
        <paragraph num="(j)">
          <text>Participates in pediatric trauma education activities such as undergraduate medical education, postgraduate training programs, and continuing education (CE); and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(2)">
        <text>A pediatric trauma program manager (TPM) who:</text>
        <paragraph num="(a)">
          <text>Is a 1.0 full-time equivalent (FTE) committed to the management of the pediatric trauma center;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Meets the requirements of Regulation .20 of this chapter; and</text>
        </paragraph>
        <paragraph num="(c)">
          <text>If the 1.0 FTE TPM has oversight of additional centers or services, the TPM is assisted by a 1.0 FTE QM nurse coordinator for each additional center or service.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="D.">
      <text>There shall be one or more committees that provide expert input to the hospital’s management of the pediatric trauma program. The committees shall:</text>
      <paragraph num="(1)">
        <text>Under the leadership of the TMD and TPM or designee, ensure physician trauma peer review includes active participation by representatives from general surgery to address clinical care issues;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Under the leadership of the TMD, conduct trauma multidisciplinary review that includes orthopedic surgery, emergency medicine, critical care, anesthesia, neurosurgery, radiology, rehabilitation, and nursing to address and ensure multidisciplinary review of clinical care and systematic issues; and</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Monitor, track, and trend pediatric trauma care within hospital departments, medical and nursing staffs, and representative disciplines across the trauma care continuum.</text>
      </paragraph>
    </paragraph>
    <paragraph num="E.">
      <text>The pediatric trauma center shall have a pediatric trauma resuscitation team:</text>
      <paragraph num="(1)">
        <text>Whose members are:</text>
        <paragraph num="(a)">
          <text>Present in house and immediately available upon notification;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Oriented to the internal pediatric trauma clinical management protocols and policies; and</text>
        </paragraph>
        <paragraph num="(c)">
          <text>Have demonstrated skills for pediatric trauma care that are appropriate and specific to their specialty roles;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(2)">
        <text>That is available in the trauma resuscitation areas upon arrival of all trauma patients when there is advanced notification;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>That follows clearly defined policies and protocols for activation criteria and roles and responsibilities;</text>
      </paragraph>
      <paragraph num="(4)">
        <text>That includes a team leader, who shall be either:</text>
        <paragraph num="(a)">
          <text>An attending pediatric surgeon; or</text>
        </paragraph>
        <paragraph num="(b)">
          <text>A postgraduate, year-3 or above general surgeon; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(5)">
        <text>That includes an in-house emergency medicine physician who has experience and training in pediatric trauma resuscitation, and shall act as the pediatric trauma resuscitation team leader until relieved by the pediatric trauma surgeon in the resuscitation area.</text>
      </paragraph>
    </paragraph>
    <paragraph num="F.">
      <text>There is a pediatric trauma multidisciplinary team that, in addition to physicians and nurses, consists of professionals with a focus on the unique needs of children and families, including:</text>
      <paragraph num="(1)">
        <text>Social work;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Child psychiatry;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Child life therapy;</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Rehabilitation services, that is, physical, occupational, and speech therapies; and</text>
      </paragraph>
      <paragraph num="(5)">
        <text>Respiratory therapy.</text>
      </paragraph>
    </paragraph>
    <paragraph num="G.">
      <text>The hospital shall have a completed interdisciplinary plan of care specific to the needs of each pediatric trauma patient that addresses all phases of care, including acute care of injuries, disposition, discharge, and rehabilitation needs.</text>
    </paragraph>
    <paragraph num="H.">
      <text>The hospital shall have written policies and procedures to direct the organized and safe interhospital transfer process of pediatric trauma patients. The hospital shall:</text>
      <paragraph num="(1)">
        <text>Complete transfers to in-State hospitals, or to out-of-State hospitals listed in the Maryland Emergency Medical Services Interhospital Transfer Resource Manual, in accordance with the guidelines contained in the Maryland Emergency Medical Services Interhospital Transfer Resource Manual, without the need for separate transfer agreements; and</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Have a written transfer agreement in place for transfer of a patient to an out-of-State hospital not listed in the Maryland Emergency Medical Services Interhospital Transfer Resource Manual, if the hospital transfers to such an out-of-State hospital more than five times a year.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".03" heading="Medical Staff.">
    <paragraph num="A.">
      <text>The hospital shall have a credentialing process. Each physician and all advance practice professionals (APPs) shall be credentialed by the hospital for the appropriate specialty, including pediatric trauma care.</text>
    </paragraph>
    <paragraph num="B.">
      <text>The hospital shall have a process for delineation and reevaluation of privileges that includes:</text>
      <paragraph num="(1)">
        <text>A pediatric trauma panel, which shall be limited to those with demonstrated skills, commitment, experience, and interest in pediatric trauma care;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Appointment and reappointment to the pediatric trauma admitting or consulting staff that is coordinated by the medical staff office; and</text>
      </paragraph>
      <paragraph num="(3)">
        <text>The delineation of privileges for the pediatric trauma admitting or consulting staff approved by the pediatric TMD based on the following criteria:</text>
        <paragraph num="(a)">
          <text>Maintenance of good standing in the primary specialty;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Evidence of the required continuing medical education in trauma;</text>
        </paragraph>
        <paragraph num="(c)">
          <text>Documented attendance at multidisciplinary meetings, morbidity and mortality (M&amp;M) rounds, and hospital peer-review conferences that deal with the care of injured patients; and</text>
        </paragraph>
        <paragraph num="(d)">
          <text>Satisfactory performance in managing pediatric trauma patients based on performance assessment and outcome analysis.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="C.">
      <text>The hospital shall have continuing medical education (CME) requirements as follows:</text>
      <paragraph num="(1)">
        <text>Pediatric surgeons taking trauma calls shall have evidence of 16 hours of trauma-related CME credits per year;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>ATLS® may be counted toward the required CME credits;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Successful completion of an ATLS® course, at least once, is required for all attending pediatric surgeons providing pediatric trauma care;</text>
      </paragraph>
      <paragraph num="(4)">
        <text>The TMD and APPs providing pediatric trauma care must maintain a current ATLS® certification; and</text>
      </paragraph>
      <paragraph num="(5)">
        <text>Physician CME credits shall be documented in accordance with hospital policy.</text>
      </paragraph>
    </paragraph>
    <paragraph num="D.">
      <text>Clinical service requirements are as follows:</text>
      <paragraph num="(1)">
        <text>Pediatric surgery:</text>
        <paragraph num="(a)">
          <text>Board-certified or board-eligible pediatric surgeons trained in trauma care;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Either:</text>
          <paragraph num="(i)">
            <text>An in-house PGY3 or higher resident or attending surgeon, who shall be at the bedside within 15 minutes of being called, with compliance demonstrated at least 80 percent of the time; or</text>
          </paragraph>
          <paragraph num="(ii)">
            <text>An attending pediatric trauma surgeon who takes out-of-the-hospital trauma calls shall be immediately available for consultation and at the bedside within 30 minutes of being called, with compliance demonstrated at least 80 percent of the time; and</text>
          </paragraph>
        </paragraph>
        <paragraph num="(c)">
          <text>General surgery APPs taking trauma call who have documentation of an average of 16 hours per year of trauma-related education.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(2)">
        <text>Pediatric neurosurgery:</text>
        <paragraph num="(a)">
          <text>Either:</text>
          <paragraph num="(i)">
            <text>A board-certified or board-eligible, trauma fellowship-trained attending neurosurgeon, or PGY2 or higher resident with an attending neurosurgeon on call, who shall be at the patient’s bedside within 30 minutes after emergent consultation has been requested; or</text>
          </paragraph>
          <paragraph num="(ii)">
            <text>A Neurosurgery APP with an attending neurosurgeon on-call, who shall be at the patient’s bedside within 30 minutes after emergent consultation has been requested;</text>
          </paragraph>
        </paragraph>
        <paragraph num="(b)">
          <text>Neurosurgery APPs taking trauma call shall have documentation of average of 16 hours a year of trauma-related education; and</text>
        </paragraph>
        <paragraph num="(c)">
          <text>A liaison to the trauma QM program with 50 percent attendance.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(3)">
        <text>Pediatric Orthopedic surgery:</text>
        <paragraph num="(a)">
          <text>Either:</text>
          <paragraph num="(i)">
            <text>A board-certified or board-eligible trauma-fellowship-trained attending orthopedic surgeon or PGY2 or higher resident with an attending orthopedic surgeon on call, who shall be at the patient’s bedside within 30 minutes after emergent consultation has been requested; or</text>
          </paragraph>
          <paragraph num="(ii)">
            <text>A PGY2 or higher orthopedic surgeon in house with an attending orthopedic surgeon on call, who shall be at the patient’s bedside within 30 minutes after emergent consultation has been requested;</text>
          </paragraph>
        </paragraph>
        <paragraph num="(b)">
          <text>Orthopedic surgery APPs taking trauma call shall have documentation of average of 16 hours a year of trauma-related education; and</text>
        </paragraph>
        <paragraph num="(c)">
          <text>A liaison to the trauma QM program with 50 percent attendance.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(4)">
        <text>Pediatric anesthesia:</text>
        <paragraph num="(a)">
          <text>A board-certified or board-eligible in-house attending physician 24 hours a day; and</text>
        </paragraph>
        <paragraph num="(b)">
          <text>A liaison to the trauma QM program with 50 percent attendance.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(5)">
        <text>Pediatric emergency medicine:</text>
        <paragraph num="(a)">
          <text>A physician director who is board certified in pediatric emergency medicine;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Board-certified or board-eligible pediatricians, emergency medicine physicians, or pediatric emergency medicine physicians in house 24 hours a day;</text>
        </paragraph>
        <paragraph num="(c)">
          <text>Physicians who have demonstrated special capabilities through commitment, CME, and experience in the care of injured children; and</text>
        </paragraph>
        <paragraph num="(d)">
          <text>A liaison to the trauma QM program with 50 percent attendance.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(6)">
        <text>Pediatric critical care:</text>
        <paragraph num="(a)">
          <text>A board-eligible or board-certified pediatric critical care physician in house 24 hours a day for the ICU;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>A designated liaison from pediatric surgery; and</text>
        </paragraph>
        <paragraph num="(c)">
          <text>A liaison to the trauma QM program with 50 percent attendance.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="E.">
      <text>The hospital shall have the following additional pediatric surgical specialties on call and available 24 hours a day, and shall be at the bedside within 30 minutes after emergent consultation has been requested by the trauma resuscitation team leader based on institution-specific criteria:</text>
      <paragraph num="(1)">
        <text>Plastic surgery;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Urology;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Oral-maxillofacial surgery;</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Ophthalmology;</text>
      </paragraph>
      <paragraph num="(5)">
        <text>Otolaryngology, head, and neck surgery;</text>
      </paragraph>
      <paragraph num="(6)">
        <text>Cardiovascular surgery; and</text>
      </paragraph>
      <paragraph num="(7)">
        <text>Hand surgery.</text>
      </paragraph>
    </paragraph>
    <paragraph num="F.">
      <text>The hospital shall have the following additional nonsurgical pediatric specialties on call and available 24 hours a day within 60 minutes after emergent consultation has been requested by the trauma resuscitation team leader based on institution-specific criteria:</text>
      <paragraph num="(1)">
        <text>Radiology;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Neuroradiology;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Interventional radiology;</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Physiatry;</text>
      </paragraph>
      <paragraph num="(5)">
        <text>Psychiatry;</text>
      </paragraph>
      <paragraph num="(6)">
        <text>Infectious disease;</text>
      </paragraph>
      <paragraph num="(7)">
        <text>General pediatrics;</text>
      </paragraph>
      <paragraph num="(8)">
        <text>Neurology;</text>
      </paragraph>
      <paragraph num="(9)">
        <text>Gastroenterology;</text>
      </paragraph>
      <paragraph num="(10)">
        <text>Nephrology;</text>
      </paragraph>
      <paragraph num="(11)">
        <text>Cardiology;</text>
      </paragraph>
      <paragraph num="(12)">
        <text>Hematology-oncology;</text>
      </paragraph>
      <paragraph num="(13)">
        <text>Pulmonology;</text>
      </paragraph>
      <paragraph num="(14)">
        <text>Endocrinology;</text>
      </paragraph>
      <paragraph num="(15)">
        <text>Pathology;</text>
      </paragraph>
      <paragraph num="(16)">
        <text>Allergy and immunology; and</text>
      </paragraph>
      <paragraph num="(17)">
        <text>Angiography.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".04" heading="Nursing Service.">
    <paragraph num="A.">
      <text>The oversight and responsibility for pediatric trauma nursing care shall be assigned within the Department of Nursing.</text>
    </paragraph>
    <paragraph num="B.">
      <text>There shall be a plan for providing adequate and appropriate nursing staff to meet the acuity needs of pediatric trauma patients in each unit of care.</text>
    </paragraph>
    <paragraph num="C.">
      <text>The nursing department shall participate in the interdisciplinary QM monitoring of pediatric trauma care.</text>
    </paragraph>
    <paragraph num="D.">
      <text>There shall be an education program for all nurses providing care for pediatric trauma patients addressing the specific care needs of the patients and their families.</text>
    </paragraph>
    <paragraph num="E.">
      <text>The education program developed and approved by the trauma quality improvement committee (TQIC) shall include:</text>
      <paragraph num="(1)">
        <text>An introductory 16-hour trauma nursing curriculum that:</text>
        <paragraph num="(a)">
          <text>Addresses resuscitation and definitive care for pediatric trauma patients; and</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Covers the continuum of care; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(2)">
        <text>A CE requirement of:</text>
        <paragraph num="(a)">
          <text>8 hours every year for emergency and critical care nurses; and</text>
        </paragraph>
        <paragraph num="(b)">
          <text>4 hours every year for nurses providing pediatric trauma care in other clinical areas.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="F.">
      <text>Nursing shall have representation at pediatric trauma multidisciplinary meetings.</text>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".05" heading="Pediatric Emergency Department (PED).">
    <text>The hospital shall have an ED dedicated to pediatric care, including:</text>
    <paragraph num="A.">
      <text>A designated and dedicated ED physician director and nurse manager;</text>
    </paragraph>
    <paragraph num="B.">
      <text>A sufficient number of registered nurses and other clinicians who:</text>
      <paragraph num="(1)">
        <text>Have the necessary knowledge and skills to provide care during trauma resuscitation;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Are present to manage projected caseloads; and</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Immediately reinforce the number of staff upon notice of multiple admissions;</text>
      </paragraph>
    </paragraph>
    <paragraph num="C.">
      <text>Defined and agreed upon roles and responsibilities approved by the TMD to ensure availability of ED resources;</text>
    </paragraph>
    <paragraph num="D.">
      <text>Verification of functioning life-safety emergency equipment and supplies organized for trauma resuscitation present and immediately available 24 hours a day;</text>
    </paragraph>
    <paragraph num="E.">
      <text>An identified pediatric trauma resuscitation room with dedicated staff, equipment, and supplies 24 hours a day;</text>
    </paragraph>
    <paragraph num="F.">
      <text>Designation by MIEMSS as a pediatric base station;</text>
    </paragraph>
    <paragraph num="G.">
      <text>Policies and protocols for trauma team response and roles in ED trauma resuscitation in accordance with Regulation .20 of this chapter; and</text>
    </paragraph>
    <paragraph num="H.">
      <text>Equipment for resuscitation of patients of all ages, including:</text>
      <paragraph num="(1)">
        <text>Airway management equipment and supplies including a “difficult airway cart”;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Emergency equipment located in the resuscitation area/ED for:</text>
        <paragraph num="(a)">
          <text>Thoracotomy;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Vascular access;</text>
        </paragraph>
        <paragraph num="(c)">
          <text>Thoracostomy or chest decompression;</text>
        </paragraph>
        <paragraph num="(d)">
          <text>Bedside ultrasound;</text>
        </paragraph>
        <paragraph num="(e)">
          <text>Extremity hemorrhage control devices/tourniquet; and</text>
        </paragraph>
        <paragraph num="(f)">
          <text>Rapid infuser and warmer;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(3)">
        <text>Medications necessary for the resuscitation and emergency care of children with immediate capability for appropriate pediatric dosages based on weight in kilograms;</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Printed pre-calculated pediatric drug dosage reference materials, including, but not limited to, charts, wall posters, and length-based dosage tapes;</text>
      </paragraph>
      <paragraph num="(5)">
        <text>The following monitoring devices:</text>
        <paragraph num="(a)">
          <text>ECG monitor/defibrillator capable of providing a hard copy rhythm strip, and with internal and external pediatric paddles capable of delivering from 0 to 360 joules;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Pulse oximeter with adult and pediatric probes;</text>
        </paragraph>
        <paragraph num="(c)">
          <text>Blood pressure cuffs in infant, child, adult, and thigh sizes;</text>
        </paragraph>
        <paragraph num="(d)">
          <text>Thermometer probe capable of reading from 28 to 42 degrees centigrade;</text>
        </paragraph>
        <paragraph num="(e)">
          <text>Otoscope;</text>
        </paragraph>
        <paragraph num="(f)">
          <text>Ophthalmoscope;</text>
        </paragraph>
        <paragraph num="(g)">
          <text>Transport monitor with pediatric capabilities;</text>
        </paragraph>
        <paragraph num="(h)">
          <text>Doppler and noninvasive blood pressure monitoring devices for infant, child, and adult;</text>
        </paragraph>
        <paragraph num="(i)">
          <text>End-tidal carbon dioxide monitor; and</text>
        </paragraph>
        <paragraph num="(j)">
          <text>Pressure monitor for central venous pressure and arterial line pressure;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(6)">
        <text>Standard intravenous fluids and administration devices, including large-bore intravenous catheters;</text>
      </paragraph>
      <paragraph num="(7)">
        <text>Newborn resuscitation supplies;</text>
      </paragraph>
      <paragraph num="(8)">
        <text>Compartmental pressure measuring devices immediately available; and</text>
      </paragraph>
      <paragraph num="(9)">
        <text>Cervical and skeletal traction devices immediately available.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".06" heading="Pediatric Operating Room (OR).">
    <paragraph num="A.">
      <text>The hospital shall have an OR adequately staffed and immediately available and equipped to care for injured children of all ages.</text>
    </paragraph>
    <paragraph num="B.">
      <text>The OR shall have supplies, equipment, medications, and staff approved by the TMD to ensure availability of optimal  resources.</text>
    </paragraph>
    <paragraph num="C.">
      <text>The OR shall have equipment and supplies for microvascular and microneural surgery</text>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".07" heading="Pediatric Post Anesthesia Care Unit (PACU).">
    <paragraph num="A.">
      <text>The hospital shall have a PACU adequately staffed, immediately available, and equipped to care for injured children.</text>
    </paragraph>
    <paragraph num="B.">
      <text>The PACU shall:</text>
      <paragraph num="(1)">
        <text>Be available to pediatric trauma patients with an appropriately trained registered nurse and other essential staff 24 hours a day to care for the multiply injured child;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Have equipment for continuous monitoring of temperature, hemodynamics, and gas exchange; and</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Have available pediatric resuscitation equipment and medications</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".08" heading="Pediatric Intensive Care Unit (PICU).">
    <paragraph num="A.">
      <text>The hospital shall have a separate PICU with the capability to care for all significantly injured children.</text>
    </paragraph>
    <paragraph num="B.">
      <text>The PICU shall:</text>
      <paragraph num="(1)">
        <text>Have appropriately trained registered nurse staff to care for the critically injured child to include:</text>
        <paragraph num="(a)">
          <text>Brain injury;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Spinal cord injury;</text>
        </paragraph>
        <paragraph num="(c)">
          <text>Solid organ injury;</text>
        </paragraph>
        <paragraph num="(d)">
          <text>Chest injury;</text>
        </paragraph>
        <paragraph num="(e)">
          <text>Complex musculoskeletal injury;</text>
        </paragraph>
        <paragraph num="(f)">
          <text>Burns;</text>
        </paragraph>
        <paragraph num="(g)">
          <text>Eye injury;</text>
        </paragraph>
        <paragraph num="(h)">
          <text>Hand and upper extremity injury; and</text>
        </paragraph>
        <paragraph num="(i)">
          <text>Lower extremity injury;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(2)">
        <text>Be staffed at a level to ensure appropriate nurse-patient ratios as determined by written nursing standards;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Have a written plan to:</text>
        <paragraph num="(a)">
          <text>Triage children from the PICU to accommodate acute admissions; or</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Provide alternative critical care beds with appropriately trained pediatric critical care registered nurses;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(4)">
        <text>Have available the pediatric resuscitation equipment and medications;</text>
      </paragraph>
      <paragraph num="(5)">
        <text>Have the equipment and capability for continuous invasive monitoring of the critically injured child;</text>
      </paragraph>
      <paragraph num="(6)">
        <text>Have extracorporeal membrane oxygenation capability;</text>
      </paragraph>
      <paragraph num="(7)">
        <text>Have capability for all renal replacement therapies; and</text>
      </paragraph>
      <paragraph num="(8)">
        <text>Have support services with immediate access to clinical diagnostic services and stat lab.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".09" heading="General Pediatric Unit.">
    <paragraph num="A.">
      <text>The hospital shall have a general pediatric unit, ideally a dedicated surgical unit to include trauma, adequately staffed 24 hours a day and equipped to care for all injured children.</text>
    </paragraph>
    <paragraph num="B.">
      <text>The general pediatric unit shall:</text>
      <paragraph num="(1)">
        <text>Have the equipment and capability to care for the child with multiple traumatic injuries;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Have appropriately trained registered nursing staff to care for the multiply injured child;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Be staffed at a level to ensure appropriate nurse-patient ratios as determined by written nursing standards;</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Have written plans for discharge and transfer of injured children to:</text>
        <paragraph num="(a)">
          <text>Appropriate inpatient rehabilitation;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Pediatric home care; and</text>
        </paragraph>
        <paragraph num="(c)">
          <text>Outpatient follow-up; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(5)">
        <text>Have the support services available for psychological support, rehabilitative therapy, and educational liaison with schools.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".10" heading="Radiological Specialty Capabilities.">
    <text>The hospital shall have:</text>
    <paragraph num="A.">
      <text>Radiological specialty capabilities and equipment to handle all injured children;</text>
    </paragraph>
    <paragraph num="B.">
      <text>Qualified pediatric radiologists and staff available within 60 minutes of consultation notification to perform complex imaging studies or interventional procedures 24 hours a day;</text>
    </paragraph>
    <paragraph num="C.">
      <text>A board-certified or board-eligible radiology attending physician on call who shall provide interpretations of radiographs within 30 minutes, in house or via teleradiology, available 24 hours a day;</text>
    </paragraph>
    <paragraph num="D.">
      <text>Changes in interpretation between preliminary and final reports, as well as missed injuries, monitored through the QM program;</text>
    </paragraph>
    <paragraph num="E.">
      <text>In-house radiology technicians 24 hours a day;</text>
    </paragraph>
    <paragraph num="F.">
      <text>Computed tomography (CT) scan with an in-house CT technician 24 hours a day;</text>
    </paragraph>
    <paragraph num="G.">
      <text>Back-up CT scan capabilities;</text>
    </paragraph>
    <paragraph num="H.">
      <text>Angiography;</text>
    </paragraph>
    <paragraph num="I.">
      <text>Sonography;</text>
    </paragraph>
    <paragraph num="J.">
      <text>Magnetic resonance imaging;</text>
    </paragraph>
    <paragraph num="K.">
      <text>Nuclear scanning; and</text>
    </paragraph>
    <paragraph num="L.">
      <text>Trans-esophageal echocardiography</text>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".11" heading="Rehabilitation Services.">
    <text>The hospital shall have:</text>
    <paragraph num="A.">
      <text>Rehabilitation capabilities adequately staffed with equipment available to treat all injured children while in the pediatric trauma center;</text>
    </paragraph>
    <paragraph num="B.">
      <text>Rehabilitation consultation services, occupational therapy, speech therapy, and physical therapy, available in the critical care phase as needed;</text>
    </paragraph>
    <paragraph num="C.">
      <text>Pediatric rehabilitation services staffed by personnel trained in pediatric rehabilitation care and properly equipped for acute care of injured pediatric patients;</text>
    </paragraph>
    <paragraph num="D.">
      <text>Full in-house service or transfer process in place to a rehabilitation service for long-term care or sub-acute care; and</text>
    </paragraph>
    <paragraph num="E.">
      <text>Transfer agreements to rehabilitation hospitals, for the primary three rehabilitation hospitals the trauma center utilizes, which may be a joint transfer agreement if the trauma center is a part of a health system that utilizes a particular rehabilitation center.</text>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".12" heading="Follow-Up Services.">
    <paragraph num="A.">
      <text>The hospital shall have follow-up services adequately staffed and equipped to treat injured children.</text>
    </paragraph>
    <paragraph num="B.">
      <text>Pediatric trauma clinic outpatient follow-up shall be available with coordination of the interdisciplinary team.</text>
    </paragraph>
    <paragraph num="C.">
      <text>Pediatric surgical and medical subspecialty clinics shall be available for follow-up care.</text>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".13" heading="Clinical Laboratory Service.">
    <paragraph num="A.">
      <text>The hospital shall have clinical laboratory service available 24 hours a day, adequately staffed and immediately available and equipped for injured children.</text>
    </paragraph>
    <paragraph num="B.">
      <text>The clinical laboratory service shall have the following services available:</text>
      <paragraph num="(1)">
        <text>Stat lab capabilities;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Standard analysis of blood, urine, and other body fluids;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Blood-typing and cross match;</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Comprehensive blood bank or access to a central blood bank in the community and adequate storage facilities with stock minimums set by protocol for blood products;</text>
      </paragraph>
      <paragraph num="(5)">
        <text>Blood gas analysis;</text>
      </paragraph>
      <paragraph num="(6)">
        <text>Coagulation studies;</text>
      </paragraph>
      <paragraph num="(7)">
        <text>Microbiology; and</text>
      </paragraph>
      <paragraph num="(8)">
        <text>Toxicological screening.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".14" heading="Quality Management.">
    <paragraph num="A.">
      <text>The hospital shall have ongoing QM of the pediatric trauma program that is integrated into the hospital's overall QM program and reported to the hospital's governing body.</text>
    </paragraph>
    <paragraph num="B.">
      <text>The following shall be included in the pediatric QM program:</text>
      <paragraph num="(1)">
        <text>A structure to ensure that defined program outcomes and performance measures are developed and monitored regularly;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>A special audit of all pediatric trauma deaths;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Review of morbidity and mortality;</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Evaluation of medical care, nursing care, utilization review, tissue review, and prehospital care;</text>
      </paragraph>
      <paragraph num="(5)">
        <text>Monthly review, at an appropriate interdisciplinary forum, of the performance of the pediatric trauma program, including:</text>
        <paragraph num="(a)">
          <text>Trends;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>All deaths;</text>
        </paragraph>
        <paragraph num="(c)">
          <text>All transfers;</text>
        </paragraph>
        <paragraph num="(d)">
          <text>Morbidities;</text>
        </paragraph>
        <paragraph num="(e)">
          <text>Problem identification and solution;</text>
        </paragraph>
        <paragraph num="(f)">
          <text>Issues identified from the QM process; and</text>
        </paragraph>
        <paragraph num="(g)">
          <text>System or administrative issues;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(6)">
        <text>Maintenance of minutes for all meetings in accordance with the hospital QM program;</text>
      </paragraph>
      <paragraph num="(7)">
        <text>Requirements for designated liaisons (medical and nursing) to attend at least 50 percent of the trauma peer review meetings, and with supporting documentation;</text>
      </paragraph>
      <paragraph num="(8)">
        <text>Requirements for all pediatric general surgeons who take pediatric trauma call to attend at least 50 percent of the trauma peer review meetings;</text>
      </paragraph>
      <paragraph num="(9)">
        <text>Documentation of QM to demonstrate the interdisciplinary approach to the QM program, including:</text>
        <paragraph num="(a)">
          <text>Problem identification;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Analysis;</text>
        </paragraph>
        <paragraph num="(c)">
          <text>Action planning;</text>
        </paragraph>
        <paragraph num="(d)">
          <text>Implementation;</text>
        </paragraph>
        <paragraph num="(e)">
          <text>Reevaluation; and</text>
        </paragraph>
        <paragraph num="(f)">
          <text>Corrective action; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(10)">
        <text>Monitoring of Level I Pediatric Trauma Center bypass status including “fly-by” and re-route events.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".15" heading="Injury Prevention and Public Education.">
    <text>The level I pediatric trauma center shall:</text>
    <paragraph num="A.">
      <text>Collaborate closely with MIEMSS and other State agencies in developing, monitoring, and evaluating the effectiveness of prevention and public education programs;</text>
    </paragraph>
    <paragraph num="B.">
      <text>Conduct epidemiology research including studies in injury control;</text>
    </paragraph>
    <paragraph num="C.">
      <text>Collaborate with other hospitals, MIEMSS, or other agencies in pediatric injury prevention initiatives and research;</text>
    </paragraph>
    <paragraph num="D.">
      <text>Have an organized and effective approach to injury that prioritizes those efforts based on the Maryland State Trauma Registry (MSTR) and epidemiologic data;</text>
    </paragraph>
    <paragraph num="E.">
      <text>Monitor progress of prevention programs in cooperation with State QM activities;</text>
    </paragraph>
    <paragraph num="F.">
      <text>Have a designated prevention coordinator;</text>
    </paragraph>
    <paragraph num="G.">
      <text>Have outreach and program development activities targeted to pediatric injury prevention within the region and State;</text>
    </paragraph>
    <paragraph num="H.">
      <text>Have information resources for children and families; and</text>
    </paragraph>
    <paragraph num="I.">
      <text>Collaborate with existing national, regional, and State programs.</text>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".16" heading="Trauma Research.">
    <text>The level I pediatric trauma center shall:</text>
    <paragraph num="A.">
      <text>Have an organized pediatric trauma research program with a designated physician director and a documented research plan;</text>
    </paragraph>
    <paragraph num="B.">
      <text>Hold regular meetings of the research group;</text>
    </paragraph>
    <paragraph num="C.">
      <text>Show evidence of productivity;</text>
    </paragraph>
    <paragraph num="D.">
      <text>Have research proposals reviewed by an institutional review board;</text>
    </paragraph>
    <paragraph num="E.">
      <text>Conduct clinical research designed to enhance the trauma system’s ability to resuscitate, stabilize, and treat trauma patients in the most cost-effective manner;</text>
    </paragraph>
    <paragraph num="F.">
      <text>Present research study results at local, regional, and national meetings; and</text>
    </paragraph>
    <paragraph num="G.">
      <text>Produce publications in peer-reviewed journals on an average of seven times per year.</text>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".17" heading="Education.">
    <text>The hospital shall:</text>
    <paragraph num="A.">
      <text>Assist MIEMSS with developing, monitoring, and evaluating the effectiveness of EMS training programs;</text>
    </paragraph>
    <paragraph num="B.">
      <text>Offer and participate in formal pediatric trauma CE for hospital personnel and community health care clinicians;</text>
    </paragraph>
    <paragraph num="C.">
      <text>Have a pediatric surgery fellowship program accredited by the Accreditation Council of Graduate Medical Education (ACGME);</text>
    </paragraph>
    <paragraph num="D.">
      <text>Participate in a general surgical residency program accredited by the ACGME;</text>
    </paragraph>
    <paragraph num="E.">
      <text>Participate in a pediatric emergency medicine fellowship program; and</text>
    </paragraph>
    <paragraph num="F.">
      <text>Participate in undergraduate medical and nursing education.</text>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".18" heading="Continuing Education (CE).">
    <paragraph num="A.">
      <text>The hospital shall provide and participate in periodic continuing education programs for physicians, nurses, and allied health personnel concerning the treatment and care of the pediatric trauma patient and family.</text>
    </paragraph>
    <paragraph num="B.">
      <text>The hospital shall:</text>
      <paragraph num="(1)">
        <text>Provide formal internal continuing education programs for physicians, nurses, and allied health professionals;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Provide orientation on pediatric trauma protocols and trauma care for all rotating physicians, nurses, and allied health personnel assigned to units where pediatric trauma care is provided; and</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Provide external continuing education programs concerning the care and treatment of pediatric trauma patients for physicians, nurses, and allied health personnel within the region and in the State.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".19" heading="Policies, Protocols, and Agreements.">
    <paragraph num="A.">
      <text>The hospital shall develop, distribute, and monitor implementation of the following patient treatment and care protocols:</text>
      <paragraph num="(1)">
        <text>Pediatric resuscitation protocol;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Procedural sedation protocols for children;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Transfusion and massive transfusion protocol;</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Infection control protocol;</text>
      </paragraph>
      <paragraph num="(5)">
        <text>Pediatric trauma resuscitation team activation protocol;</text>
      </paragraph>
      <paragraph num="(6)">
        <text>Physician call schedule and notification protocol;</text>
      </paragraph>
      <paragraph num="(7)">
        <text>Interhospital transfer protocol;</text>
      </paragraph>
      <paragraph num="(8)">
        <text>Helicopter safety protocol;</text>
      </paragraph>
      <paragraph num="(9)">
        <text>Organ procurement protocol;</text>
      </paragraph>
      <paragraph num="(10)">
        <text>Child protection team protocol;</text>
      </paragraph>
      <paragraph num="(11)">
        <text>Pediatric psychosocial care protocol; and</text>
      </paragraph>
      <paragraph num="(12)">
        <text>Pediatric rehabilitation care protocol.</text>
      </paragraph>
    </paragraph>
    <paragraph num="B.">
      <text>The hospital shall have written transfer agreements with specialty and pediatric rehabilitation centers.</text>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".20" heading="Trauma Program Manager.">
    <paragraph num="A.">
      <text>There shall be a TPM who is a registered nurse responsible for the organization of services and systems necessary for a multidisciplinary approach to providing care to the injured patient in collaboration and conjunction with the TMD.</text>
    </paragraph>
    <paragraph num="B.">
      <text>There shall be a defined organizational structure, which delineates the roles and responsibilities of the TPM.</text>
    </paragraph>
    <paragraph num="C.">
      <text>The TPM shall be a 1.0 FTE position dedicated to the management of the pediatric trauma center.</text>
    </paragraph>
    <paragraph num="D.">
      <text>The institution’s organization shall define the structural role of the TPM to include responsibility, accountability, and authority.</text>
    </paragraph>
    <paragraph num="E.">
      <text>The TPM shall:</text>
      <paragraph num="(1)">
        <text>Have a job description developed by the hospital to reflect the role and responsibilities and identified on an organizational chart depicting the relationship between the TPM and other services, including the Department of Nursing;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Attend and participate in local, state and national trauma-related activities, including but not limited to EMS community, state trauma-related committees and events, and national trauma-related activities and events;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Show evidence of 16 hours of trauma-related CE a year, and, over a 2-year period, half of the CE hours shall be obtained outside the hospital and be recognized by a national accrediting body;</text>
      </paragraph>
      <paragraph num="(4)">
        <text>As requested, participate in multidisciplinary trauma research;</text>
      </paragraph>
      <paragraph num="(5)">
        <text>Have sufficient administrative and budgetary commitment in order to support the needs of the trauma center inclusive of clerical and clinical nursing personnel that help fulfill the needs of concurrent performance improvement, outreach, and injury prevention functions;</text>
      </paragraph>
      <paragraph num="(6)">
        <text>Supervise the Trauma Registry staff and trauma clinical QM staff and have oversite for injury prevention and outreach; and</text>
      </paragraph>
      <paragraph num="(7)">
        <text>With the TMD, have oversight and approval of internal trauma-related education programs.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".21" heading="Trauma Registry.">
    <paragraph num="A.">
      <text>The Trauma Center shall maintain a pediatric Trauma Registry with participation in the MSTRB. The Trauma Registry shall include, at a minimum, all of the data elements compliant with the MSTR Data Dictionary for Pediatric Patients, including:</text>
      <paragraph num="(1)">
        <text>Demographic data;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Pre-hospital data;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Process of acute care;</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Clinical data;</text>
      </paragraph>
      <paragraph num="(5)">
        <text>Outcome data;</text>
      </paragraph>
      <paragraph num="(6)">
        <text>Final anatomical diagnoses;</text>
      </paragraph>
      <paragraph num="(7)">
        <text>Procedure codes;</text>
      </paragraph>
      <paragraph num="(8)">
        <text>QM data;</text>
      </paragraph>
      <paragraph num="(9)">
        <text>Standard report utilization; and</text>
      </paragraph>
      <paragraph num="(10)">
        <text>Case inclusion criteria.</text>
      </paragraph>
    </paragraph>
    <paragraph num="B.">
      <text>The Trauma Registry shall support the trauma center with evidence of active interface with the institution and State QM process to improve the care of injured patients across the continuum from injury prevention to outcomes measurement.</text>
    </paragraph>
    <paragraph num="C.">
      <text>The Trauma Registry may be under a separate department that provides support and conducts the registry data abstraction with a reporting structure to the TMD and TPM.</text>
    </paragraph>
    <paragraph num="D.">
      <text>The Trauma Program Manager shall have the authority, responsibility, accountability, and oversight of the Trauma Registry, inclusive of data submission as required by MIEMSS.</text>
    </paragraph>
    <paragraph num="E.">
      <text>The Trauma Registry shall have:</text>
      <paragraph num="(1)">
        <text>A staffing plan that includes workload analysis that defines personnel needs necessary to comply with the MIEMSS data submission requirements, and</text>
      </paragraph>
      <paragraph num="(2)">
        <text>One trauma registrar (1.0 FTE) dedicated to the trauma program for every 500—750 patients, subject to meeting performance standards and MIEMSS-defined submissions per year.</text>
      </paragraph>
    </paragraph>
    <paragraph num="F.">
      <text>All discharged trauma patient records, with the minimum quarterly and annual data elements with the number of patients, shall be verified no later than 6 weeks after the end of each quarter.</text>
    </paragraph>
    <paragraph num="G.">
      <text>All records shall be completed within 60 days of patient discharge.</text>
    </paragraph>
    <paragraph num="H.">
      <text>Validation and National Trauma Data Bank (NTDB) checks shall be completed and the records shall be closed except when a medical examiner (ME) autopsy report is not yet available for registry record abstraction.</text>
    </paragraph>
    <paragraph num="I.">
      <text>The Trauma Registry shall have a plan to ensure Inter-rater reliability of the data entered. Ongoing review and evaluation shall ensure the quality, reliability and validity of the institution’s MSTR data.</text>
    </paragraph>
    <paragraph num="J.">
      <text>The Trauma Center shall submit data to the NTDB.</text>
    </paragraph>
    <paragraph num="K.">
      <text>Trauma Registry staff shall have:</text>
      <paragraph num="(1)">
        <text>A job description developed by the hospital to reflect roles and responsibilities;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Core requirements including:</text>
        <paragraph num="(a)">
          <text>Anatomy and physiology;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Medical terminology; and</text>
        </paragraph>
        <paragraph num="(c)">
          <text>Education to be completed within 1 year of hire includes:</text>
          <paragraph num="(i)">
            <text>American Trauma Society Trauma Registrar Course; and</text>
          </paragraph>
          <paragraph num="(ii)">
            <text>Association of the Advancement of Automotive Medicine’s Injury Scaling Course; and</text>
          </paragraph>
        </paragraph>
      </paragraph>
      <paragraph num="(3)">
        <text>Job responsibilities to include:</text>
        <paragraph num="(a)">
          <text>Ensuring assigned cases are compliant with Maryland Data Dictionary Inclusion Criteria or other trauma center self-defined criteria;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Compiling abstracted data for MSTR case from various sources; and</text>
        </paragraph>
        <paragraph num="(c)">
          <text>Appropriately coding injuries, complications, and procedures.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="L.">
      <text>The Trauma Registry staff liaison shall:</text>
      <paragraph num="(1)">
        <text>Attend a minimum of 50 percent all trauma multidisciplinary/peer review meetings that are held; and</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Actively participate in the Maryland TQIC.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".22" heading="Emergency Preparedness.">
    <paragraph num="A.">
      <text>The trauma center shall have a hospital emergency preparedness or disaster plan described in the hospital’s policy and procedure manual or equivalent.</text>
    </paragraph>
    <paragraph num="B.">
      <text>The hospital disaster plan shall have a hazards vulnerability analysis to guide the response plan.</text>
    </paragraph>
    <paragraph num="C.">
      <text>Hospital Incident Command System shall be used as a management system for incident command, planning, logistics, operations, and finance/administrative functions.</text>
    </paragraph>
    <paragraph num="D.">
      <text>A tiered approach depending on the magnitude of the event and alternatives for care shall be identified.</text>
    </paragraph>
    <paragraph num="E.">
      <text>The trauma center shall be represented on the hospital’s emergency preparedness or disaster committee.</text>
    </paragraph>
    <paragraph num="F.">
      <text>The trauma center hospital shall:</text>
      <paragraph num="(1)">
        <text>Participate in local, state, or national disaster management meetings, plans, and exercises;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Conduct hospital drills that test the hospital’s disaster plan at least twice a year, including actual plan activations that can substitute for drills; and</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Have a written plan for supporting trauma center.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <annotations>
    <annotation type="Authority">Education Article, §13-509, Annotated Code of Maryland</annotation>
    <annotation type="History" subtype="Administrative History">Effective date: September 7, 1998 (25:18 Md. R. 1439)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .01B amended effective July 1, 2002 (29:12 Md. R. 933)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .03E amended effective June 4, 2007 (34:11 Md. R. 972)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .06C amended effective July 1, 2002 (29:12 Md. R. 933)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .16A amended effective July 1, 2002 (29:12 Md. R. 933)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .16 amended effective June 4, 2007 (34:11 Md. R. 972)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .18A amended effective July 1, 2002 (29:12 Md. R. 933)</annotation>
    <annotation type="History" subtype="Administrative History">Regulations .01—.20 repealed and new regulations .01 — .22 adopted effective July 24, 2023 (50:14 Md. R. 594)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .02B amended effective July 21, 2025 (52:14 Md. R. 714)</annotation>
  </annotations>
</chapter>