# COMAR Title 30 — Maryland Institute for Emergency Medical Services Systems (MIEMSS)

## Subtitle 08 — Designation of Trauma and Specialty Referral Centers

### Chapter 08 — Pediatric Trauma Center Standards

**Authority:** Education Article, §13-509, Annotated Code of Maryland

**Administrative History:** Effective date: September 7, 1998 (25:18 Md. R. 1439)

**Administrative History:** Regulation .01B amended effective July 1, 2002 (29:12 Md. R. 933)

**Administrative History:** Regulation .03E amended effective June 4, 2007 (34:11 Md. R. 972)

**Administrative History:** Regulation .06C amended effective July 1, 2002 (29:12 Md. R. 933)

**Administrative History:** Regulation .16A amended effective July 1, 2002 (29:12 Md. R. 933)

**Administrative History:** Regulation .16 amended effective June 4, 2007 (34:11 Md. R. 972)

**Administrative History:** Regulation .18A amended effective July 1, 2002 (29:12 Md. R. 933)

**Administrative History:** Regulations .01—.20 repealed and new regulations .01 — .22 adopted effective July 24, 2023 (50:14 Md. R. 594)

**Administrative History:** Regulation .02B amended effective July 21, 2025 (52:14 Md. R. 714)

#### Regulation .01 Definitions.

*COMAR 30.08.08.01*

A. In this chapter, the following term has the meaning indicated.

B. 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:

  (1) In-State hospital designated by MIEMSS and approved by the EMS Board to provide comprehensive pediatric trauma care services; or

  (2) 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.

#### Regulation .02 Organization.

*COMAR 30.08.08.02*

A. The hospital's board of directors, administrators, and medical and nursing staffs shall demonstrate commitment to the optimal care of injured pediatric patients by:

  (1) Formulating a board of director's resolution stating that:

    (a) The hospital agrees to meet the Maryland Pediatric Trauma Center designation standards; and

    (b) 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;

  (2) Establishing an identifiable organization whose dedication to the care of injured children is shown in:

    (a) Its mission statement;

    (b) The configuration of its medical, administrative, and support staffs; and

    (c) The configuration of its physical plant;

  (3) Participating in the Statewide trauma system, including submission of patient care data to the State Trauma Registry for system and quality management (QM);

  (4) Assuring that all pediatric trauma patients shall receive medical care commensurate with the hospital's designation as a pediatric trauma center; and

  (5) 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.

B. The hospital shall:

  (1) 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;

  (2) Be accredited by an organization that has been granted deeming authority by the Centers for Medicare & Medicaid Services and approved by the Maryland Department of Health to accredit hospitals in the State;

  (3) Maintain current equipment and technology to support optimal pediatric trauma care;

  (4) Admit annually 200 or more injured children who are younger than 15 years old;

  (5) Have the ability to treat effectively all types of pediatric injuries, including:

    (a) Brain injury;

    (b) Spinal cord injury;

    (c) Solid organ injury;

    (d) Chest injury;

    (e) Complex musculoskeletal injury;

    (f) Burns;

    (g) Eye injury;

    (h) Hand and upper extremity injury; and

    (i) Lower extremity injury; and

  (6) Have a heliport or helipad positioned at the closest safe location so there is a limited distance from the helipad to the hospital.

C. The pediatric trauma center shall have a pediatric trauma leadership team responsible for monitoring and coordinating all components of the pediatric trauma program, including:

  (1) A pediatric trauma medical director (TMD) who:

    (a) Is a board-certified pediatric surgeon;

    (b) Demonstrates expertise and commitment to the care of injured children;

    (c) With the trauma program manager (TPM), is empowered by the hospital’s governing body to lead the pediatric trauma center;

    (d) 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;

    (e) Has the responsibility for the oversight of the QM process related to all pediatric trauma patients;

    (f) Participates in and publishes pediatric trauma research;

    (g) Has a job description developed by the hospital to reflect the role and responsibilities as defined by COMAR;

    (h) Appears on the hospital’s organizational chart where the relationship between the TMD and other hospital services are depicted and delineated;

    (i) Participates in local, regional, state and national activities related to pediatric injury care and prevention; and

    (j) Participates in pediatric trauma education activities such as undergraduate medical education, postgraduate training programs, and continuing education (CE); and

  (2) A pediatric trauma program manager (TPM) who:

    (a) Is a 1.0 full-time equivalent (FTE) committed to the management of the pediatric trauma center;

    (b) Meets the requirements of Regulation .20 of this chapter; and

    (c) 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.

D. There shall be one or more committees that provide expert input to the hospital’s management of the pediatric trauma program. The committees shall:

  (1) 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;

  (2) 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

  (3) Monitor, track, and trend pediatric trauma care within hospital departments, medical and nursing staffs, and representative disciplines across the trauma care continuum.

E. The pediatric trauma center shall have a pediatric trauma resuscitation team:

  (1) Whose members are:

    (a) Present in house and immediately available upon notification;

    (b) Oriented to the internal pediatric trauma clinical management protocols and policies; and

    (c) Have demonstrated skills for pediatric trauma care that are appropriate and specific to their specialty roles;

  (2) That is available in the trauma resuscitation areas upon arrival of all trauma patients when there is advanced notification;

  (3) That follows clearly defined policies and protocols for activation criteria and roles and responsibilities;

  (4) That includes a team leader, who shall be either:

    (a) An attending pediatric surgeon; or

    (b) A postgraduate, year-3 or above general surgeon; and

  (5) 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.

F. 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:

  (1) Social work;

  (2) Child psychiatry;

  (3) Child life therapy;

  (4) Rehabilitation services, that is, physical, occupational, and speech therapies; and

  (5) Respiratory therapy.

G. 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.

H. The hospital shall have written policies and procedures to direct the organized and safe interhospital transfer process of pediatric trauma patients. The hospital shall:

  (1) 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

  (2) 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.

#### Regulation .03 Medical Staff.

*COMAR 30.08.08.03*

A. 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.

B. The hospital shall have a process for delineation and reevaluation of privileges that includes:

  (1) A pediatric trauma panel, which shall be limited to those with demonstrated skills, commitment, experience, and interest in pediatric trauma care;

  (2) Appointment and reappointment to the pediatric trauma admitting or consulting staff that is coordinated by the medical staff office; and

  (3) The delineation of privileges for the pediatric trauma admitting or consulting staff approved by the pediatric TMD based on the following criteria:

    (a) Maintenance of good standing in the primary specialty;

    (b) Evidence of the required continuing medical education in trauma;

    (c) Documented attendance at multidisciplinary meetings, morbidity and mortality (M&M) rounds, and hospital peer-review conferences that deal with the care of injured patients; and

    (d) Satisfactory performance in managing pediatric trauma patients based on performance assessment and outcome analysis.

C. The hospital shall have continuing medical education (CME) requirements as follows:

  (1) Pediatric surgeons taking trauma calls shall have evidence of 16 hours of trauma-related CME credits per year;

  (2) ATLS® may be counted toward the required CME credits;

  (3) Successful completion of an ATLS® course, at least once, is required for all attending pediatric surgeons providing pediatric trauma care;

  (4) The TMD and APPs providing pediatric trauma care must maintain a current ATLS® certification; and

  (5) Physician CME credits shall be documented in accordance with hospital policy.

D. Clinical service requirements are as follows:

  (1) Pediatric surgery:

    (a) Board-certified or board-eligible pediatric surgeons trained in trauma care;

    (b) Either:

      (i) 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

      (ii) 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

    (c) General surgery APPs taking trauma call who have documentation of an average of 16 hours per year of trauma-related education.

  (2) Pediatric neurosurgery:

    (a) Either:

      (i) 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

      (ii) 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;

    (b) Neurosurgery APPs taking trauma call shall have documentation of average of 16 hours a year of trauma-related education; and

    (c) A liaison to the trauma QM program with 50 percent attendance.

  (3) Pediatric Orthopedic surgery:

    (a) Either:

      (i) 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

      (ii) 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;

    (b) Orthopedic surgery APPs taking trauma call shall have documentation of average of 16 hours a year of trauma-related education; and

    (c) A liaison to the trauma QM program with 50 percent attendance.

  (4) Pediatric anesthesia:

    (a) A board-certified or board-eligible in-house attending physician 24 hours a day; and

    (b) A liaison to the trauma QM program with 50 percent attendance.

  (5) Pediatric emergency medicine:

    (a) A physician director who is board certified in pediatric emergency medicine;

    (b) Board-certified or board-eligible pediatricians, emergency medicine physicians, or pediatric emergency medicine physicians in house 24 hours a day;

    (c) Physicians who have demonstrated special capabilities through commitment, CME, and experience in the care of injured children; and

    (d) A liaison to the trauma QM program with 50 percent attendance.

  (6) Pediatric critical care:

    (a) A board-eligible or board-certified pediatric critical care physician in house 24 hours a day for the ICU;

    (b) A designated liaison from pediatric surgery; and

    (c) A liaison to the trauma QM program with 50 percent attendance.

E. 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:

  (1) Plastic surgery;

  (2) Urology;

  (3) Oral-maxillofacial surgery;

  (4) Ophthalmology;

  (5) Otolaryngology, head, and neck surgery;

  (6) Cardiovascular surgery; and

  (7) Hand surgery.

F. 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:

  (1) Radiology;

  (2) Neuroradiology;

  (3) Interventional radiology;

  (4) Physiatry;

  (5) Psychiatry;

  (6) Infectious disease;

  (7) General pediatrics;

  (8) Neurology;

  (9) Gastroenterology;

  (10) Nephrology;

  (11) Cardiology;

  (12) Hematology-oncology;

  (13) Pulmonology;

  (14) Endocrinology;

  (15) Pathology;

  (16) Allergy and immunology; and

  (17) Angiography.

#### Regulation .04 Nursing Service.

*COMAR 30.08.08.04*

A. The oversight and responsibility for pediatric trauma nursing care shall be assigned within the Department of Nursing.

B. 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.

C. The nursing department shall participate in the interdisciplinary QM monitoring of pediatric trauma care.

D. 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.

E. The education program developed and approved by the trauma quality improvement committee (TQIC) shall include:

  (1) An introductory 16-hour trauma nursing curriculum that:

    (a) Addresses resuscitation and definitive care for pediatric trauma patients; and

    (b) Covers the continuum of care; and

  (2) A CE requirement of:

    (a) 8 hours every year for emergency and critical care nurses; and

    (b) 4 hours every year for nurses providing pediatric trauma care in other clinical areas.

F. Nursing shall have representation at pediatric trauma multidisciplinary meetings.

#### Regulation .05 Pediatric Emergency Department (PED).

*COMAR 30.08.08.05*

The hospital shall have an ED dedicated to pediatric care, including:

A. A designated and dedicated ED physician director and nurse manager;

B. A sufficient number of registered nurses and other clinicians who:

  (1) Have the necessary knowledge and skills to provide care during trauma resuscitation;

  (2) Are present to manage projected caseloads; and

  (3) Immediately reinforce the number of staff upon notice of multiple admissions;

C. Defined and agreed upon roles and responsibilities approved by the TMD to ensure availability of ED resources;

D. Verification of functioning life-safety emergency equipment and supplies organized for trauma resuscitation present and immediately available 24 hours a day;

E. An identified pediatric trauma resuscitation room with dedicated staff, equipment, and supplies 24 hours a day;

F. Designation by MIEMSS as a pediatric base station;

G. Policies and protocols for trauma team response and roles in ED trauma resuscitation in accordance with Regulation .20 of this chapter; and

H. Equipment for resuscitation of patients of all ages, including:

  (1) Airway management equipment and supplies including a “difficult airway cart”;

  (2) Emergency equipment located in the resuscitation area/ED for:

    (a) Thoracotomy;

    (b) Vascular access;

    (c) Thoracostomy or chest decompression;

    (d) Bedside ultrasound;

    (e) Extremity hemorrhage control devices/tourniquet; and

    (f) Rapid infuser and warmer;

  (3) Medications necessary for the resuscitation and emergency care of children with immediate capability for appropriate pediatric dosages based on weight in kilograms;

  (4) Printed pre-calculated pediatric drug dosage reference materials, including, but not limited to, charts, wall posters, and length-based dosage tapes;

  (5) The following monitoring devices:

    (a) 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;

    (b) Pulse oximeter with adult and pediatric probes;

    (c) Blood pressure cuffs in infant, child, adult, and thigh sizes;

    (d) Thermometer probe capable of reading from 28 to 42 degrees centigrade;

    (e) Otoscope;

    (f) Ophthalmoscope;

    (g) Transport monitor with pediatric capabilities;

    (h) Doppler and noninvasive blood pressure monitoring devices for infant, child, and adult;

    (i) End-tidal carbon dioxide monitor; and

    (j) Pressure monitor for central venous pressure and arterial line pressure;

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

  (7) Newborn resuscitation supplies;

  (8) Compartmental pressure measuring devices immediately available; and

  (9) Cervical and skeletal traction devices immediately available.

#### Regulation .06 Pediatric Operating Room (OR).

*COMAR 30.08.08.06*

A. The hospital shall have an OR adequately staffed and immediately available and equipped to care for injured children of all ages.

B. The OR shall have supplies, equipment, medications, and staff approved by the TMD to ensure availability of optimal  resources.

C. The OR shall have equipment and supplies for microvascular and microneural surgery

#### Regulation .07 Pediatric Post Anesthesia Care Unit (PACU).

*COMAR 30.08.08.07*

A. The hospital shall have a PACU adequately staffed, immediately available, and equipped to care for injured children.

B. The PACU shall:

  (1) 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;

  (2) Have equipment for continuous monitoring of temperature, hemodynamics, and gas exchange; and

  (3) Have available pediatric resuscitation equipment and medications

#### Regulation .08 Pediatric Intensive Care Unit (PICU).

*COMAR 30.08.08.08*

A. The hospital shall have a separate PICU with the capability to care for all significantly injured children.

B. The PICU shall:

  (1) Have appropriately trained registered nurse staff to care for the critically injured child to include:

    (a) Brain injury;

    (b) Spinal cord injury;

    (c) Solid organ injury;

    (d) Chest injury;

    (e) Complex musculoskeletal injury;

    (f) Burns;

    (g) Eye injury;

    (h) Hand and upper extremity injury; and

    (i) Lower extremity injury;

  (2) Be staffed at a level to ensure appropriate nurse-patient ratios as determined by written nursing standards;

  (3) Have a written plan to:

    (a) Triage children from the PICU to accommodate acute admissions; or

    (b) Provide alternative critical care beds with appropriately trained pediatric critical care registered nurses;

  (4) Have available the pediatric resuscitation equipment and medications;

  (5) Have the equipment and capability for continuous invasive monitoring of the critically injured child;

  (6) Have extracorporeal membrane oxygenation capability;

  (7) Have capability for all renal replacement therapies; and

  (8) Have support services with immediate access to clinical diagnostic services and stat lab.

#### Regulation .09 General Pediatric Unit.

*COMAR 30.08.08.09*

A. 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.

B. The general pediatric unit shall:

  (1) Have the equipment and capability to care for the child with multiple traumatic injuries;

  (2) Have appropriately trained registered nursing staff to care for the multiply injured child;

  (3) Be staffed at a level to ensure appropriate nurse-patient ratios as determined by written nursing standards;

  (4) Have written plans for discharge and transfer of injured children to:

    (a) Appropriate inpatient rehabilitation;

    (b) Pediatric home care; and

    (c) Outpatient follow-up; and

  (5) Have the support services available for psychological support, rehabilitative therapy, and educational liaison with schools.

#### Regulation .10 Radiological Specialty Capabilities.

*COMAR 30.08.08.10*

The hospital shall have:

A. Radiological specialty capabilities and equipment to handle all injured children;

B. Qualified pediatric radiologists and staff available within 60 minutes of consultation notification to perform complex imaging studies or interventional procedures 24 hours a day;

C. 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;

D. Changes in interpretation between preliminary and final reports, as well as missed injuries, monitored through the QM program;

E. In-house radiology technicians 24 hours a day;

F. Computed tomography (CT) scan with an in-house CT technician 24 hours a day;

G. Back-up CT scan capabilities;

H. Angiography;

I. Sonography;

J. Magnetic resonance imaging;

K. Nuclear scanning; and

L. Trans-esophageal echocardiography

#### Regulation .11 Rehabilitation Services.

*COMAR 30.08.08.11*

The hospital shall have:

A. Rehabilitation capabilities adequately staffed with equipment available to treat all injured children while in the pediatric trauma center;

B. Rehabilitation consultation services, occupational therapy, speech therapy, and physical therapy, available in the critical care phase as needed;

C. Pediatric rehabilitation services staffed by personnel trained in pediatric rehabilitation care and properly equipped for acute care of injured pediatric patients;

D. Full in-house service or transfer process in place to a rehabilitation service for long-term care or sub-acute care; and

E. 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.

#### Regulation .12 Follow-Up Services.

*COMAR 30.08.08.12*

A. The hospital shall have follow-up services adequately staffed and equipped to treat injured children.

B. Pediatric trauma clinic outpatient follow-up shall be available with coordination of the interdisciplinary team.

C. Pediatric surgical and medical subspecialty clinics shall be available for follow-up care.

#### Regulation .13 Clinical Laboratory Service.

*COMAR 30.08.08.13*

A. The hospital shall have clinical laboratory service available 24 hours a day, adequately staffed and immediately available and equipped for injured children.

B. The clinical laboratory service shall have the following services available:

  (1) Stat lab capabilities;

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

  (3) Blood-typing and cross match;

  (4) 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;

  (5) Blood gas analysis;

  (6) Coagulation studies;

  (7) Microbiology; and

  (8) Toxicological screening.

#### Regulation .14 Quality Management.

*COMAR 30.08.08.14*

A. 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.

B. The following shall be included in the pediatric QM program:

  (1) A structure to ensure that defined program outcomes and performance measures are developed and monitored regularly;

  (2) A special audit of all pediatric trauma deaths;

  (3) Review of morbidity and mortality;

  (4) Evaluation of medical care, nursing care, utilization review, tissue review, and prehospital care;

  (5) Monthly review, at an appropriate interdisciplinary forum, of the performance of the pediatric trauma program, including:

    (a) Trends;

    (b) All deaths;

    (c) All transfers;

    (d) Morbidities;

    (e) Problem identification and solution;

    (f) Issues identified from the QM process; and

    (g) System or administrative issues;

  (6) Maintenance of minutes for all meetings in accordance with the hospital QM program;

  (7) Requirements for designated liaisons (medical and nursing) to attend at least 50 percent of the trauma peer review meetings, and with supporting documentation;

  (8) Requirements for all pediatric general surgeons who take pediatric trauma call to attend at least 50 percent of the trauma peer review meetings;

  (9) Documentation of QM to demonstrate the interdisciplinary approach to the QM program, including:

    (a) Problem identification;

    (b) Analysis;

    (c) Action planning;

    (d) Implementation;

    (e) Reevaluation; and

    (f) Corrective action; and

  (10) Monitoring of Level I Pediatric Trauma Center bypass status including “fly-by” and re-route events.

#### Regulation .15 Injury Prevention and Public Education.

*COMAR 30.08.08.15*

The level I pediatric trauma center shall:

A. Collaborate closely with MIEMSS and other State agencies in developing, monitoring, and evaluating the effectiveness of prevention and public education programs;

B. Conduct epidemiology research including studies in injury control;

C. Collaborate with other hospitals, MIEMSS, or other agencies in pediatric injury prevention initiatives and research;

D. Have an organized and effective approach to injury that prioritizes those efforts based on the Maryland State Trauma Registry (MSTR) and epidemiologic data;

E. Monitor progress of prevention programs in cooperation with State QM activities;

F. Have a designated prevention coordinator;

G. Have outreach and program development activities targeted to pediatric injury prevention within the region and State;

H. Have information resources for children and families; and

I. Collaborate with existing national, regional, and State programs.

#### Regulation .16 Trauma Research.

*COMAR 30.08.08.16*

The level I pediatric trauma center shall:

A. Have an organized pediatric trauma research program with a designated physician director and a documented research plan;

B. Hold regular meetings of the research group;

C. Show evidence of productivity;

D. Have research proposals reviewed by an institutional review board;

E. Conduct clinical research designed to enhance the trauma system’s ability to resuscitate, stabilize, and treat trauma patients in the most cost-effective manner;

F. Present research study results at local, regional, and national meetings; and

G. Produce publications in peer-reviewed journals on an average of seven times per year.

#### Regulation .17 Education.

*COMAR 30.08.08.17*

The hospital shall:

A. Assist MIEMSS with developing, monitoring, and evaluating the effectiveness of EMS training programs;

B. Offer and participate in formal pediatric trauma CE for hospital personnel and community health care clinicians;

C. Have a pediatric surgery fellowship program accredited by the Accreditation Council of Graduate Medical Education (ACGME);

D. Participate in a general surgical residency program accredited by the ACGME;

E. Participate in a pediatric emergency medicine fellowship program; and

F. Participate in undergraduate medical and nursing education.

#### Regulation .18 Continuing Education (CE).

*COMAR 30.08.08.18*

A. 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.

B. The hospital shall:

  (1) Provide formal internal continuing education programs for physicians, nurses, and allied health professionals;

  (2) 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

  (3) 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.

#### Regulation .19 Policies, Protocols, and Agreements.

*COMAR 30.08.08.19*

A. The hospital shall develop, distribute, and monitor implementation of the following patient treatment and care protocols:

  (1) Pediatric resuscitation protocol;

  (2) Procedural sedation protocols for children;

  (3) Transfusion and massive transfusion protocol;

  (4) Infection control protocol;

  (5) Pediatric trauma resuscitation team activation protocol;

  (6) Physician call schedule and notification protocol;

  (7) Interhospital transfer protocol;

  (8) Helicopter safety protocol;

  (9) Organ procurement protocol;

  (10) Child protection team protocol;

  (11) Pediatric psychosocial care protocol; and

  (12) Pediatric rehabilitation care protocol.

B. The hospital shall have written transfer agreements with specialty and pediatric rehabilitation centers.

#### Regulation .20 Trauma Program Manager.

*COMAR 30.08.08.20*

A. 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.

B. There shall be a defined organizational structure, which delineates the roles and responsibilities of the TPM.

C. The TPM shall be a 1.0 FTE position dedicated to the management of the pediatric trauma center.

D. The institution’s organization shall define the structural role of the TPM to include responsibility, accountability, and authority.

E. The TPM shall:

  (1) 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;

  (2) 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;

  (3) 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;

  (4) As requested, participate in multidisciplinary trauma research;

  (5) 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;

  (6) Supervise the Trauma Registry staff and trauma clinical QM staff and have oversite for injury prevention and outreach; and

  (7) With the TMD, have oversight and approval of internal trauma-related education programs.

#### Regulation .21 Trauma Registry.

*COMAR 30.08.08.21*

A. 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:

  (1) Demographic data;

  (2) Pre-hospital data;

  (3) Process of acute care;

  (4) Clinical data;

  (5) Outcome data;

  (6) Final anatomical diagnoses;

  (7) Procedure codes;

  (8) QM data;

  (9) Standard report utilization; and

  (10) Case inclusion criteria.

B. 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.

C. 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.

D. The Trauma Program Manager shall have the authority, responsibility, accountability, and oversight of the Trauma Registry, inclusive of data submission as required by MIEMSS.

E. The Trauma Registry shall have:

  (1) A staffing plan that includes workload analysis that defines personnel needs necessary to comply with the MIEMSS data submission requirements, and

  (2) 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.

F. 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.

G. All records shall be completed within 60 days of patient discharge.

H. 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.

I. 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.

J. The Trauma Center shall submit data to the NTDB.

K. Trauma Registry staff shall have:

  (1) A job description developed by the hospital to reflect roles and responsibilities;

  (2) Core requirements including:

    (a) Anatomy and physiology;

    (b) Medical terminology; and

    (c) Education to be completed within 1 year of hire includes:

      (i) American Trauma Society Trauma Registrar Course; and

      (ii) Association of the Advancement of Automotive Medicine’s Injury Scaling Course; and

  (3) Job responsibilities to include:

    (a) Ensuring assigned cases are compliant with Maryland Data Dictionary Inclusion Criteria or other trauma center self-defined criteria;

    (b) Compiling abstracted data for MSTR case from various sources; and

    (c) Appropriately coding injuries, complications, and procedures.

L. The Trauma Registry staff liaison shall:

  (1) Attend a minimum of 50 percent all trauma multidisciplinary/peer review meetings that are held; and

  (2) Actively participate in the Maryland TQIC.

#### Regulation .22 Emergency Preparedness.

*COMAR 30.08.08.22*

A. The trauma center shall have a hospital emergency preparedness or disaster plan described in the hospital’s policy and procedure manual or equivalent.

B. The hospital disaster plan shall have a hazards vulnerability analysis to guide the response plan.

C. Hospital Incident Command System shall be used as a management system for incident command, planning, logistics, operations, and finance/administrative functions.

D. A tiered approach depending on the magnitude of the event and alternatives for care shall be identified.

E. The trauma center shall be represented on the hospital’s emergency preparedness or disaster committee.

F. The trauma center hospital shall:

  (1) Participate in local, state, or national disaster management meetings, plans, and exercises;

  (2) 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

  (3) Have a written plan for supporting trauma center.