A Burn center shall: Maintain a designated unit or units for specialized acute burn care; Be a hospital designated as a Level II or higher trauma center; If an in-State hospital, have one of the following issued by the Maryland Health Care Commission: A certificate of need; or An exception from the requirement for a certificate of need; Demonstrate commitment to the optimal care of the hospital’s burn injured patients by the hospital’s board of directors, administration, medical staff, and nursing staff by formulating a board of director’s resolution, updated yearly, stating that: The hospital agrees to meet the burn center designation standards; The hospital has a commitment to the infrastructure and the financial, human, and physical resources necessary to support the hospital’s burn center designation; and The hospital has a commitment to the quality management (QM) process of the burn patient; 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; 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 out-of-State hospital more than five times a year; Have a written transfer agreement in place for transfer of a patient to a rehabilitation hospital if the hospital transfers to such a rehabilitation hospital more than two times a year; Have and maintain current accreditation 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; Use the resources of the burn center for patients with burn injuries and those suffering from burn-like diseases; and Have administrative and budgetary commitment in order to support the needs of the burn center, inclusive of clerical and clinical nursing personnel, that helps fulfill needs of the concurrent PI, outreach, injury prevention, and research. Prehospital Care. A burn center shall: Maintain access to an EMS system for the transport of patients (public safety and commercial services) with burns from referral sources within the geographic service area; Participate in regional or State EMS committees and councils at least three times per year; Have a written hospital emergency preparedness/multiple casualty incident (MCI) plan for the triage and early treatment of adult and pediatric patients burned in an MCI; Ensure that the MCI plan for the geographic service area is reviewed and updated on an annual basis by the hospital Emergency Preparedness Committee and EMS liaisons and drill inclusive of burn patients annually; and Provide education on the current concepts in triage and burn care treatment to prehospital and hospital care providers within its geographic service area. Documentation of Policies and Procedures. A burn center shall formally establish and maintain an organized burn service that is responsible for coordinating the care of the burn patient. A burn center shall maintain an organizational chart relating personnel within the burn unit to other hospital staff; a combined leadership model for trauma and burn center is acceptable. A burn center shall maintain an appropriate policy and procedure manual that: Is reviewed annually by the burn center director and the burn nursing leader; and Addresses: Administration of the burn center; Staffing and programs of the burn center; Criteria for admission to the burn unit by the burn service; Usage of the burn unit beds by other medical or surgical services; Criteria for discharge and follow-up care; Availability of beds and the transfer of burn patients to other medical or surgical units within the hospital; and Care of patients with burns in areas of the burn center other than the burn units. Consistency of Data Collected and Reported. The burn center shall participate in the State Burn Registry for burn patients, both inpatient and outpatient modules. The State Burn Registry shall include all patients who are treated at the burn center inclusive of outpatient and inpatient venues for burn care treatment. Minimum Volume for the Burn Center. A burn center shall treat an average of 100 or more unique inpatients and outpatients (ED treat and discharge and first clinic visit) with acute burn injuries annually. A burn center shall admit at least 60 patients annually who meet the referral criteria in Regulation .17 of this chapter. General. A burn center director is authorized to direct and coordinate all medical services for patients admitted to the burn service. Medical care for patients in the burn center shall be provided by the burn center director or qualified physicians approved by the director and shall conform to burn center care protocols. Privileges for physicians participating in the burn service shall be approved by the burn center director and determined by the medical staff credentialing process. Qualifications and Activities of a Burn Center Director. A burn center shall appoint a qualified burn center director to oversee the care of patients in the burn service. A burn center director shall meet the requirements in Regulation .05 of this chapter. Responsibilities of a Burn Center Director. The responsibilities of a burn center director are identified in a job description and include but are not limited to: Creation of policies and procedures within the burn center that specify the care of burn patients and ensures that medical care conforms to burn center protocols; Creation of policies and protocols for use throughout the burn care system for initial care, triage, and transport of burn patients; Cooperation with regional EMS authorities in regard to all aspects of burn treatment; Communication with physicians and other authorities regarding patients who have been referred and admitted for follow-up and/or feedback; Direction of a burn center’s administrative functions; Direction and active participation in a burn center quality management program; Acting as liaison between adjacent and regional burn centers; Development of and participation in both internal and external continuing medical education programs in the care of burn injuries; Maintaining current ABLS®; and Oversight of the burn prevention program and initiatives. A burn center director may appoint qualified attending burn staff surgeons to participate in the care of patients in the burn service. An attending burn staff surgeon shall meet the requirements in Regulation .05 of this chapter. The burn medical director shall serve on the medical staff as the burn chief of service. Director Surgeon A. Certification. Certification qualifications are as follows: (1) Board certified or board eligible in general or plastic surgery; E E (2) Board certification of special qualification in critical care; and D D (3) For the pediatric burn center, the pediatric burn medical director and the burn surgeons have Board certification or Board eligibility in pediatric surgery, plastic surgery, and general/acute care surgery. E E B. Training. Training qualifications are as follows: (1) 2 or more years of burn care experience during the previous 5 years; and E D (2) Either: (a) Completion of a fellowship in burn treatment or training; or E E (b) Completion of a general surgical residency. C. Clinical Activity. The clinical activity qualification requires participation in the care of 35 or more acutely burned patients annually who meet regulation criteria in Regulation.17 of this chapter. E E D. Have at least one full-time equivalent (FTE) attending burn staff surgeon involved in the management of burn patients for the equivalent of 200 acute inpatient admissions annually, with five new unique outpatients equating to one inpatient. E E E. Have an attending burn staff surgeon available on call 24 hours a day, who shall be at the bedside within 30 minutes after emergent consultation has been requested based on institution-specific criteria. E E F. Have an in-house physician assigned to the burn service on call and available at the patient’s bedside available within 15 minutes of the call for the burn units. E E G. Continuing Medical Education (CME). The CME qualification requires annual participation in 16 hours or more of burn-related CME. E E H. Research Participation. The research participation qualification is to demonstrate a commitment to clinical or basic science burn care research, which can be met by: (1) Submission of an abstract at least every 5 years to a national meeting dealing with burns, emergency medicine, or trauma; or E D (2) Research projects, completed or in progress. E D I. Community Education and Burn Prevention. The community education and burn preventions qualification is: (1) Participation in: E D (a) The development or revision of community or EMS burn treatment protocols; or D D (b) Representation on a State or regional EMS or trauma committee; and D D (2) At least 1 of the following: E D (a) Annual participation in one or more prehospital training/certification courses in burn care which can be met by prehospital basic life support or advanced life support courses or equivalent courses (ABLS®, ATLS®); (b) Annual development of presentation of acute burn care courses or lectures which can be met by prehospital basic life support or advanced life support courses or equivalent courses; or (c) Participation in a burn prevention program. Note: E = Essential; D = Desired Emergency department attending physicians may provide coverage for acute resuscitation when the burn surgeon is not on-site. In the absence of the burn surgeon, the emergency department physician shall have the authority to provide initial resuscitation and treatment of the burn injured patient. Burn unit coverage (i.e., hospitalists, intensivists, etc.) shall: Be assigned to the burn service; Be available within 15 minutes, 24 hours a day; For the adult burn center, be current in ATLS® or ABLS®; and Have a liaison to the burn QM program with 50 percent attendance. The burn center shall maintain an on-call schedule and back-up call list for residents and attending burn staff surgeons who are assigned to the burn service. Advanced practice professionals (APPs) providing initial resuscitation to the burn patient shall have: For the adult burn center, be current in ATLS® or ABLS®; and A liaison to the burn QM program with 50 percent attendance. The following surgical specialties shall be 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 surgical trauma team leader based on institution-specific criteria: General surgery/pediatric surgery; Thoracic surgery; Neurologic surgery; Obstetrics/gynecology; Ophthalmology; Orthopedic surgery; Otorhinolaryngology; Plastic surgery; Urology; and Vascular. The following nonsurgical specialties shall be 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 surgical trauma team leader based on institution-specific criteria: Anesthesiology; Critical care medicine; Pediatrics; Psychiatry; Interventional radiology (perform complex imaging studies or interventional procedures); and Interventional angiography. The following nonsurgical specialties shall be on call and available 24 hours a day and shall be at the bedside within 60 minutes after emergent consultation has been requested by the burn attending team leader based on institution-specific criteria: Cardiology; Patient protection service (adult or child); Gastroenterology; Hematology; Infectious disease; Nephrology; Neurology; Pathology; and Pulmonology. The following nonsurgical specialties shall be on call and available for consultation 24 hours a day based on institution-specific criteria: Psychology; and Physiatry. Clinical Nurse Managers for Burn Units. A burn center shall have a clinical nurse manager who is administratively responsible for the burn unit. A nurse manager shall: Be a registered nurse; Have a baccalaureate or higher degree in nursing; Have at least two of the following qualifications: An active role in burn QM program and processes; An active role in nursing research; An active role in burn prevention; 12 months or more of experience in acute burn care; 2 years or more of experience in intensive care unit or surgical care unit appropriate to the specific unit; or 6 months or more managerial experience; and Participate in QM, burn research, and burn prevention. A burn center shall have an organizational chart relating the nurse manager to the burn service and other members of the burn team. Nursing Staff. A burn center shall: Have qualified nurses to take care of burn patients; Have a plan to determine staffing and overall care including: Nurse staffing for each patient in the burn unit; and Daily staffing, including for surge and capacity needs; Have a burn unit orientation program that documents nursing competencies specific to care and treatment of burn patients, including critical care, wound care, psychosocial, and rehabilitation, inclusive of a basic trauma course; Require each new staff nurse hired for the burn units to complete the orientation program before assuming independent practice in the burn units; and Provide burn center staff with a minimum of continuing education annually of: 8 hours divided annually between burn care and trauma care, including a minimum of 2 hours of burn specific content for ED, OR, PACU, and critical care nurses; 4 hours divided between burn care and trauma care, including a minimum of 1 hour of burn specific content for other acute care nurses; and For the adult burn center, within 2 years of the completion of burn orientation, an RN shall have current ABLS®. A burn center shall: Have a rehabilitation program, including physical therapy, occupational therapy, and speech therapy, that is designed for the burn patient and identifies specific goals; Require therapists to be appropriately licensed or registered in their specific disciplines; Base staffing upon both inpatient and outpatient activity with at least one full-time equivalent (FTE) burn therapist for the burn unit; Assign a therapist to the burn center for both inpatients and outpatients, either: Permanently; or On a rotating basis for at least 1 year; Provide therapists with regular supervision from individuals with at least 1 year of experience in the treatment of burn patients; Provide a competency-based burn therapy orientation program for all new therapists assigned to the burn unit; and Provide burn unit therapists with a minimum of two burn-related continuing education opportunities annually. A burn center shall: Have a social service consultation available to the burn service; and Assign a social worker to the burn center for both inpatients and outpatients, either: Permanently; or On a rotating basis for at least 1 year. A burn center shall have a licensed dietician available daily for consultation. A burn center shall have the following personnel available 24 hours a day: A pharmacist available for consultation; A respiratory therapist to assess and manage patients on the burn service; and For pediatric burn centers, a child life specialist. Policies and Procedures. A burn service shall have a QM program that is multidisciplinary. A burn center director is responsible for the QM program. A burn unit multidisciplinary committee shall: Oversee the QM program; Meet at least monthly; and Maintain sufficient documentation to: Verify problems; Identify opportunities for improvement; Take corrective actions; and Demonstrate evidence of loop closure. Weekly Patient Care Conferences. A burn center shall hold patient care conferences at least weekly to review and evaluate the status of each patient admitted to the burn center. Each clinical discipline shall be represented to appropriately contribute to the treatment plan for each patient. Patient care conferences shall be documented in the progress notes of each patient or in minutes of the conferences. A burn center shall: Hold morbidity and mortality conferences at least monthly; and Maintain appropriate documentation of morbidity and mortality conferences. A burn center shall conduct focused quality reviews at least annually that shall include: Severity of burns; Mortality; Incidence of complications; Length of hospitalizations; and Hospital charges for care. Medical Staff Education. A burn center shall have an educational program for the medical staff. If residents rotate on the burn service, a burn service director or the director’s designee shall provide an orientation program for new residents. Infection Control Program. A burn center shall have effective means of isolation that are consistent with principles or universal precautions and barrier techniques to decrease the risk of cross-infection and cross-contamination. A burn center shall: Provide ongoing review and analysis of nosocomial infection data and risk factors that relate to infection prevention and control for burn patients; and Make these data available to the burn service in order to assess infection risk for burn unit patients. Continuity of Care Program. A burn center shall have access to the following services: Recreational or child-life therapy; Psychosocial support for family members or other significant persons; Availability for continuing age appropriate academic courses for the patient; Coordinated discharge planning; Follow-up after hospital discharge; Access to community resources; Evaluation of the patient’s physical, psychological, developmental, and vocational status; and Planning for future rehabilitative and reconstructive needs. A burn unit shall have: At least four burn unit beds with critical care capacity; and The following equipment in the adult burn center: Weight measurement devices for kilogram measurement; Difficult airway equipment capable for surgical intervention; Emergency carts with age-appropriate equipment; and Temperature control/measurement devices for: The patient; Intravenous fluids; and Blood products. A burn center shall have available the following services for burn patients 24 hours a day: Renal dialysis; Radiographs; Angiography; Ultrasonography; Nuclear medicine scanning; CT scanning; Clinical laboratory services; and Blood bank services. A burn center shall have an operating room available to the burn service 24 hours a day for appropriate and timely treatment. An emergency department shall have written protocols for treating acutely burned patients that are consistent with the burn treatment protocols. A burn center shall: Maintain a written policy stating: That allograft tissues are to be obtained only from those tissues banks that adhere to the standards of the American Association of Tissue Banks, if applicable; and Compliance with U.S. Food and Drug Administration regulations published in 21 CFR Part 1270 Human Tissue Intended for Transplantation; Develop and implement policies and procedures related to obtaining, storing, and handling of homograft and heterograft skin, if the use of biological membranes is a component of care provided by the burn center in compliance with the Joint Commission standards; and Ensure that the operative notes and record support the documentation of all allograft transplants. A burn injury requiring referral to a burn center includes: A partial thickness or full thickness burn greater than 10 percent total body surface area (TBSA) in patients younger than 10 years old; A partial thickness or full thickness burn greater than 20 percent TBSA in other age groups; A partial thickness or full thickness burn that involves the face, hands, feet, genitalia, perineum, and major joints; All full thickness burns greater than 5 percent TBSA in any age group; An electrical/lightening injury; A chemical injury; An inhalation injury; Frostbite and cold injury; A burn injury in patients with preexisting medical disorders that could: Complicate management; Prolong recovery; and Affect mortality; A burn injury with concomitant trauma, such as a fracture, in which the burn injury poses the greatest risk of morbidity in accordance with the following considerations: If trauma poses the greater immediate risk, the patient may be treated initially in the trauma center until stable before being transferred to a burn center; and Physician judgment is necessary in these situations and shall be in concert with the regional medical control plan and triage protocols; A burn injury in a child who has not reached their fifteenth (15th) birthday, who shall be treated in a pediatric burn center designated by MIEMSS; and A burn injury in patients who will require special social, emotional, or long-term rehabilitative support including cases involving suspected child abuse or substance abuse. The burn center shall: Collaborate closely with MIEMSS and other State agencies in developing, monitoring, and evaluating the effectiveness of prevention and public education programs; Conduct epidemiology research concerning burn injury control; Collaborate with other hospitals, MIEMSS, or other agencies in burn injury prevention initiatives and research; Have an organized and effective approach to burn injury prevention that prioritizes those efforts based on burn registry and epidemiologic data; Have a designated burn injury prevention coordinator, separate from the BPM position, who, in conjunction with the BPM, facilitates outreach and injury prevention strategies specific to the population of the burn center; and Collaborate with existing national, regional, State and local programs. A burn center shall have: A. An organized burn-related research program with a designated physician director; E B. A written research plan developed and reviewed yearly; E C. A dedicated master’s prepared researcher, separate from the BPM; D D. Regular meetings of the research group; E E. Evidence of productivity through peer review; E F. Proposals reviewed by an institutional review board; E G. Presentations at local, regional, or national meetings; and E H. Publications in three or greater peer-reviewed journals. E Note: E = Essential; D = Desired There shall be a burn program manager (BPM) who is a registered nurse and is 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 burn medical director (BMD). This shall be a full-time (1.0 FTE) position dedicated to the management of the burn center. Where the burn center has 1.0 FTE for the burn and trauma manager, it shall have a dedicated 1.0 FTE QM nurse coordinator. The institution’s organization shall define the structural role of the BPM to include responsibility, accountability, and authority as reflected in the organizational chart. The BPM shall: Provide evidence and maintenance of qualifications including academic and burn-related education and clinical experience; Comply with a job description developed by the hospital that reflects the role and responsibilities as defined by COMAR, and an organizational chart depicting the relationship between the BPM and other services, including the Department of Nursing/Trauma and Burn Nursing; Ensure participation in local, State, and national burn-related activities, including but not limited to EMS Advisory Councils, State burn-related committees and events, and national burn-related activities and events; Participate in burn educational activities external to the institution’s staff development programs; Maintain and provide evidence of 8 hours annually of internal and 8 hours external burn-related CE; and Supervise burn registry staff, burn clinical performance improvement staff, injury prevention staff, and outreach staff. The burn center shall maintain the State Burn Registry (BR). The State Burn Registry shall include, at a minimum, all of the data elements compliant with the Maryland Trauma Registry Data Dictionary for Burn Registry and American Burn Association National Burn Repository (NBR), including: Demographic data; Injury data; Hospital data; Description of injury; Diagnosis; Comorbidities; Procedure codes; Complications; Outcome; and Outpatient module, which includes outpatient information, Lund and Browder, treatment, complications, and comorbidities. The BR shall support the burn center with evidence of active interface with the institution and State QA/QI process to improve the care of the injured patient across the continuum from injury prevention to outcomes measurement. The BR content staff shall be under the direct supervision of the BPM/BMD. The BPM shall have the authority, responsibility, accountability, and oversight of the BR, inclusive of data submission (i.e., ED treat and release, admission, clinic and outpatient) as required by MIEMSS. The BR shall have one burn registrar (1.0 FTE) dedicated to the burn center for every 500—750 MIEMSS defined encounters per year. All discharged burn 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 the quarter, as required by MIEMSS. Within 60 days of patient discharge, all records shall be completed, validation and NBR checks shall be done, and the records shall be closed. An exception to the completeness of the BR record is with Medical Examiner (ME) cases where an autopsy is unavailable for registry record abstraction. There shall be a plan to ensure inter-rater reliability of the data entered into the BR at the individual burn centers. Ongoing review and evaluation shall ensure the quality, reliability, and validity of the institution’s BR data. Burn center data shall be submitted to the National Burn Registry Repository per the annual call for data. The BR staff shall have a core set of skill requirements including: Anatomy and physiology; and Medical terminology. Education to be completed within 1 year of hire includes the American Trauma Society Trauma Registrar Course. Education to be completed within 1 year of hire includes an International Classification of Diseases Coding Course (most recent version). Job responsibilities include: Ensuring assigned cases are compliant with MD Data Dictionary Inclusion Criteria or other burn center self-defined criteria; Compiling abstracted data for BR case from various sources; and Appropriately coding injuries, complications, and procedures. A job description developed by the hospital to reflect the role and responsibilities as defined by COMAR. Education Article, §13-509, Annotated Code of Maryland Effective date: March 24, 1997 (24:6 Md. R. 488) Regulation .04 amended effective July 1, 2002 (29:12 Md. R. 933) Regulation .06 amended effective July 1, 2002 (29:12 Md. R. 933) Chapter revised as an emergency provision effective June 1, 2006 (33:15 Md. R. 1277); revised permanently effective October 23. 2006 (33:21 Md. R. 1679) Regulation .02B amended effective June 4, 2007 (34:11 Md. R. 972) Regulations .01—.18 repealed and new Regulations .01—.21 adopted effective July 1, 2020 (47:5 Md. R. 313) Regulation .01A amended effective July 21, 2025 (52:14 Md. R. 714)