This subtitle establishes: Procedures for designating a hospital as a trauma or specialty referral center; Standards for a designated center to provide trauma or specialty care service; Procedures for disciplinary action to be taken if a trauma or specialty referral center fails to comply with this subtitle; and Procedures for the collection and use of trauma or specialty care data by MIEMSS to monitor and evaluate the trauma and specialty care systems. In this subtitle, the following terms have the meanings indicated. Terms Defined. “Adult burn center” means: An in-State hospital designated by MIEMSS and approved by the EMS Board to provide comprehensive burn treatment services to burn patients 15 years old or older; or An out-of-State hospital that has entered into an agreement with MIEMSS and that has been approved by the EMS Board to provide comprehensive burn treatment services to burn patients 15 years old or older. “Adult trauma center” means: An in-State hospital designated by MIEMSS and approved by the EMS Board to provide comprehensive trauma services to trauma patients 15 years old and older; or An out-of-State hospital that has entered into an agreement with MIEMSS and that has been approved by the EMS Board to provide comprehensive trauma treatment services to trauma patients 15 years old and older. “Advanced Burn Life Support (ABLS®)” means a course developed and approved by the American Burn Association. “Advanced Pediatric Life Support (APLS®)” means a course developed and approved by the American Academy of Pediatrics (AAP) and American College of Emergency Physicians (ACEP). “Advanced practice professionals (APPs)” are non-physicians that are educated at an advanced level to provide patient care in a range of settings; they include nurse practitioners (NPs), nurse anesthetists, midwives, clinical nurse specialists (CNS) and physician assistants (PAs). “Advanced Trauma Life Support (ATLS®)” means a course developed and approved by the American College of Surgeons. “Appropriately trained” means a health care provider who has received the necessary training to develop the knowledge and skills needed for the appropriate care of the trauma or specialty care patient. “Approved” means a formal process of review and acceptance by the appropriate authority. “Attending” “Attending burn staff surgeon” means a surgical member of the burn team appointed by the adult or pediatric burn center director with credentials and privileges appropriate to the burn service. “Board certified” means a physician certified by an appropriate specialty board recognized by the American Board of Medical Specialties. “Board eligible” means a physician qualified to take the examination to complete the certification process as specified by an appropriate specialty board that is recognized by the American Board of Medical Specialties. “Burn care director” means a surgeon designated by the institution and medical staff to coordinate the activities of the adult or pediatric burn center. “Burn care system” means a coordinated component of an emergency medical services system which encompasses one or more adult or pediatric burn centers and features communication links to, and triage-transfer protocols between, health care facilities, prehospital personnel, and transportation services. “Burn Center” means an adult or pediatric burn center in Maryland unless otherwise indicated. “Burn service” means a clinical service established by the medical staff which has responsibility for burn patients. “Burn team” means a group of health care professionals organized to provide care to the burn patient in a coordinated system of care. “Burn unit” means a specific area within the adult or pediatric burn center that: Has committed the resources necessary to meet the criteria for an adult or pediatric burn center; and Contains beds and other physical equipment related to care of the patient with burn injury. “Bypass” means the diversionary status of a trauma or specialty referral center that is requested and identified in the County/Hospital Alert Tracking System (CHATS) in accordance with a MIEMSS or regional program due to a lack of staff, facilities, or equipment. “Continuing education (CE)” means education provided for adults after they have left the formal education system consisting of short or part-time courses that brings participants up to date in a particular area of knowledge or skills. “Continuing medical education (CME)” means training approved by the Accreditation Council of Continuing Medical Education or accredited by a state medical society recognized by that Council. “Credentialing” means a hospital's process for granting practice privileges to health care providers. “Data quality guideline” means a written procedure for ascertaining the accuracy and completeness of data. “Dedicated” means a designated resource whose primary use is for a specific trauma or specialty care program. “Definitive care” means a level of therapeutic intervention capable of providing comprehensive services for the patient's particular injuries, or associated conditions, or both. “Designation” means a process by which a hospital is identified by MIEMSS as an appropriate facility to receive patients with particular injuries or illnesses. “Desirable” means a component of the standards whose presence or availability is encouraged but not required for designation. “Emergency department (ED)” means a department or patient care area within a hospital which: Is organized to provide emergency medical care 24 hours a day; and Meets the applicable standards in COMAR 30.08.05. Emergency Medical Services. “Emergency medical services (EMS)” means a comprehensive system of emergency medical care that starts with prevention and continues through rehabilitation. “Emergency medical services (EMS)” includes: Comprehensive EMS, trauma, and specialty care system legislation, regulations, and policies; Medical oversight and physician involvement; Trained volunteer, career, and commercial personnel; State and local government resource management and administration; Integrated communications system including 911 centers, medical consultation centers, ambulances, and receiving hospitals; Medical ground, air, and water transportation systems; Cooperating facilities including hospitals, trauma centers, and specialty referral centers; Public information, education, and prevention programs; and Data collection, evaluation, quality improvement, and research. “EMS Plan” means the plan to ensure effective coordination and evaluation of emergency medical services delivered in the State, as developed and approved by the EMS Board. “EMS provider” means an individual certified or licensed by a state to provide out-of-hospital emergency medical services. “Emergent consultation” means a physician consultation required for evaluation of known or potentially unstable injuries, injuries requiring time sensitive surgical interventions, or other reasons as determined and documented by the attending trauma, or general surgeon, or ED attending physician. “Essential” means a component of the standards that is required for designation. “Executive Director” means the Executive Director of MIEMSS. Repealed. “Fellowship” means formal, advanced, postresidency, specialty training. “Geographic proximity” means that distance, which is optional for Level III perinatal centers and mandatory for Level III+ perinatal centers, so that patients requiring Level IV services may be transported from a Level III or Level III+ sending facility to the Level IV perinatal center in less than 30 minutes by nonemergency transport. “Geographic service area” means the area defined by the EMS Board that is normally served by a designated hospital for patients with a particular illness or injury. “Immediately available” means a source available as soon as it is requested. “Immediate response” means reacting at once to a patient care need. “In-house” means physically present in the hospital. “Injury surveillance” means routine monitoring of the type of injury and incidence for a specific population. “Inpatient discharge data” means certain information from inpatient hospital records that is submitted by the hospital to the Health Services Cost Review Commission as required by law. “Interfacility transfer” means the transfer of a patient from one hospital to another hospital. “Learning outcomes” means an individual's performance, which can be measured by objective means, that results from the individual's participation in an educational program. “Level I trauma center” means a hospital that: Meets the Level I trauma center standards in COMAR 30.08.05; and Is designated by MIEMSS and approved by the EMS Board. “Level II trauma center” means a hospital that: Meets the Level II trauma center standards in COMAR 30.08.05; and Is designated by MIEMSS and approved by the EMS Board. Repealed. “Level III perinatal referral center” means a hospital that: Meets the Level III perinatal referral center standards in COMAR 30.08.12; Is designated by MIEMSS and approved by the EMS Board as capable of providing medical intensive care to newborns of all: Gestational ages; and Birth weights. “Level III trauma center” means a community hospital with a trauma program which meets the Level III trauma center standards in COMAR 30.08.05. “Level IV perinatal referral center” means a hospital that: Meets the Level IV perinatal referral center standards in COMAR 30.08.12; and Provides comprehensive neonatal and obstetrical services, including all subspecialty services. “Maryland Trauma Registry Data Dictionary for Adult Patients” means the listing of data inclusion criteria, data elements and audit filters to be collected on patients with traumatic injuries treated in a Maryland Trauma Center which is incorporated by reference in COMAR 30.01.02.01(B)(2). “Maternal-fetal medicine” means a subspecialty recognized by the American Board of Obstetrics and Gynecology which addresses the medical care of high-risk pregnant women and their fetuses. Most Critical Patients. “Most critical patients” means those patients who: Have confirmed BP< 90 mmHg at any time in adults and age-specific hypotension; Have GSW to the head, neck, chest, or abdomen attributed to trauma; Have a GCS score <9 with mechanism attributed to trauma; Are transferred from other hospitals receiving blood or vasoactives to maintain vital signs; Are intubated and transferred from the scene; or Have a respiratory compromise or are in need of an emergent airway, including intubated patients who are transferred from another facility with ongoing respiratory compromise. “Most critical patients” includes those patients who: Are intubated and are currently stable from a respiratory standpoint; Have a tourniquet or pelvic binder applied; Are currently in Cardiac arrest or receiving CPR; Have presence of motor paralysis; Have an amputation proximal to the ankle or wrist; Have Hypoxia as evidenced by saturation <90 percent; Have uncontrolled external hemorrhage; or Penetrating torso injury with evisceration. “Multidisciplinary committee” means a group of health care professionals from two or more professional disciplines within a trauma or specialty referral center that reflects the multidisciplinary nature of trauma or specialty care. “Multiple casualty incident (MCI)” means two or more injured people requiring emergency care simultaneously. “National Trauma Data Bank (NTDB)” means the American College of Surgeons (ACS) aggregated trauma registry of standardization of key trauma data elements for research and improving care for the surgical patient. “Neonatal referral center” means an out-of-State facility that has entered into an agreement with MIEMSS which has been approved by the EMS Board to accept transfers in order to provide neonatal care. “Neonate” means a patient who is less than 28 days old. “Neonatologist” means a pediatrician certified by the American Board of Pediatrics in neonatology. “Neurotrauma center” means an in-State hospital designated by MIEMSS and approved by the EMS Board to provide specialized care of traumatic brain injured and spinal cord injured patients. “Nurse manager” means a registered nurse who has a full-time commitment to a specific patient care unit and is administratively responsible for the nursing service of that unit. “Office of Administrative Hearings (OAH)” means the unit within Maryland's Executive Branch responsible for scheduling and conducting administrative hearings. “Office of Hospital Programs” means the office within MIEMSS that is responsible for the designation, verification, and reverification of the trauma and specialty care programs. “On call” means committed for a specific time period to be available and respond within the specific amount of time to provide care for a patient in the hospital. On-Site Review Record. “On-site review record” means any record of the on-site visit and of the on-site review team. “On-site review record” includes, but is not limited to: Proceedings; Records; Files; Notes; Deliberations; Reports; Documents; Statements; Minutes; and Any other oral or written communication. “Optional” means a component of the standards that may be present or available but is not required for designation. “Outcome” means a measurable health status that follows as a result of an injury or illness. “Patient care log” means a list of patients' names and other information that is recorded by hospitals or prehospital care agencies. “Patient care record” means a record that contains information regarding the assessment and the care provided to a patient by any health care provider in any practice setting. “Patient discharge summary” means an abbreviated narrative, created after discharge from a health care facility, of a patient's record during that hospitalization. “Patient identifier” means a unique number that is assigned to only one patient in order to identify records pertaining to the evaluation and care of that particular patient. “Pediatric Advanced Life Support (PALS®)” means a pediatric resuscitation course developed and approved by the American Heart Association. “Pediatric burn center” means: An in-State hospital designated by MIEMSS and approved by the EMS Board to provide comprehensive burn treatment services to burn patients that have not reached their fifteenth (15th) birthday; or An out-of-State hospital that has entered into an agreement with MIEMSS and that has been approved by the EMS Board to provide comprehensive burn treatment services to burn patients that have not reached their fifteenth (15th) birthday. “Pediatric trauma center” means: An in-State hospital designated by MIEMSS and approved by the EMS Board to provide comprehensive trauma services to trauma patients who have not reached their fifteenth (15th) birthday; or An out-of-State hospital that has entered into an agreement with MIEMSS and that has been approved by the EMS Board to provide compressive trauma treatment services to trauma patients who have not reached their fifteenth (15th) birthday. “Perinatal referral center” means: An in-State hospital designated by MIEMSS and approved by the EMS Board to provide comprehensive obstetrical and neonatal services; or An out-of-State hospital that has entered into an agreement with MIEMSS which has been approved by the EMS Board to provide comprehensive obstetrical and neonatal services. “Person” means: An individual or group of individuals; A State or federal agency; or A business entity. “Physical plant” means a building and associated structures. “Postgraduate year (PGY)” means a classification system for residents indicating the year of post-medical school residency. “Prehospital service” means a service that is provided from the time of injury or illness until the patient arrives in the hospital. “Preliminary investigation” means fact finding and information gathering to enable MIEMSS to determine whether justification exists to initiate disciplinary action or to conduct a further investigation. “Primary Adult Resource Center (PARC)” means a comprehensive trauma program, including a dedicated trauma care facility, dedicated staff and services, and designated, specialized, advanced training and research programs, which meets the PARC standards in COMAR 30.08.05 and which, in Maryland, is defined in statute as the R Adams Cowley Shock Trauma Center. “Promptly available” means a resource available within 30 minutes of the time it was requested. “Protocol” means a written procedure to ensure standardization of a process. “Quality management (QM)” means the quality management of trauma and specialty care services. “Quality management program record” means a documented record related to quality management activities. “Readily available” means a resource available for use a short time after it is requested. “Resuscitation” means the phase of trauma or specialty care where emergency life support treatment is provided to sustain vital body functions. “Reverification” means the process by which MIEMSS renews a trauma or specialty referral center's designation status. “Sonologist” means a physician with special training in ultrasonography. “Specialty referral center” means: An in-State hospital that has been designated by MIEMSS and approved by the EMS Board to provide care for a specific patient population with special care needs; or An out-of-State facility that has entered into an agreement with MIEMSS which has been approved by the EMS Board to provide specialty care. “State trauma registry” means a database of information, submitted to MIEMSS by hospitals, relating to the care of trauma and burn patients that is used to evaluate the quality of care provided. “SYSCOM” means the Systems Communications Center, an EMS communications center located within MIEMSS, that is used for coordination of medical communication on a Statewide basis. “Transfer agreement” means a formal agreement between hospitals for the transfer and acceptance of patients. “Transporting service” means an agency or entity providing patient care transport. “Transport vehicle” means a vehicle or other conveyance used to transport patients. “Trauma” means a major single system or multisystem injury or mechanism of injury which has a reasonable probability of disability or death. Trauma Center. “Trauma center” means a hospital that has been designated by MIEMSS and approved by the EMS Board to provide care to trauma patients. “Trauma center” includes an out-of-State facility that has entered into an agreement with MIEMSS which has been approved by the EMS Board to provide care to trauma patients. “Trauma Network (TraumaNet)” means an organization of representatives of trauma centers which includes trauma surgeons, trauma coordinators, and hospital administrators. “Trauma panel” means the group of physicians within a specific trauma center credentialed by the trauma center hospital to provide trauma care. “Trauma patient care resource” means the physical facilities, equipment, supplies, and medical personnel that are: Used to provide care to trauma patients; and Identified as immediately available, readily available, or promptly available. “Trauma Quality Improvement Committee (TQIC)” is a medical review committee established by MIEMSS as an advisory body for quality issue and evaluation affecting the care of trauma patients and the Maryland Trauma System. The TQIC will address issues primarily related to the system-wide delivery of trauma care across the continuum (pre-hospital care to discharge from the trauma center) identifying performance improvement activities and indicators to support resolution strategies. “Trauma resuscitation team” means a group of trauma trained health care providers required to be present at the patient’s bedside following trauma team activation. The minimum team requirements for all levels of activation include: trauma attending/general surgeon/PGY4/APP, ED lead physician, ED RN’s, and a recorder/documenter. The highest level of response requires, at a minimum, the trauma resuscitation team, an anesthesiologist or CRNA (as per institutional-specific criteria), and Respiratory Therapy. “Trauma service” means a group of trauma-trained physicians that are responsible for the initial resuscitation and care of the trauma patient, including trauma/general surgeon, emergency medicine, neurosurgery, and orthopedic surgery. “Trend” means a tendency towards a particular conclusion or end point, usually determined by an analysis of data. “Triage” means the sorting of patients in terms of priority, treatment, transportation, and destination, so that the patient can be transported to the appropriate hospital according to triage protocols. “Unit of care” means the hospital subunit where the patient is receiving care at any point in time. “Verification” means the process by which MIEMSS determines that a hospital, which is applying for a particular designation status, is in substantial compliance with the standards for the designation requested. Under Education Article, §13-504, Annotated Code of Maryland, MIEMSS is the State administrative agency responsible for the coordination of all emergency medical services. MIEMSS shall: With the approval of the EMS Board, designate and verify hospitals to be trauma or specialty referral centers; Establish standards for trauma and specialty care, triage, and transfer protocols for injured patients; Establish and manage the State trauma registry; Facilitate the establishment of Statewide, inclusive, trauma and specialty care systems by encouraging all hospitals to participate in: The Statewide data collection process, and Prevention programs; Develop a quality management and improvement program to: Monitor compliance with this subtitle by hospitals in the Statewide trauma and specialty care systems, and Identify areas for enhancement; With the consultation and advice of appropriate persons, develop and periodically review: Prehospital trauma and specialty referral center triage criteria guidelines, Interfacility transfer criteria for adult and pediatric patients, Trauma and specialty referral center standards, and Trauma registry and specialty referral center data; Annually evaluate the effectiveness of the Statewide trauma and specialty care systems and its component subsystems by using trauma registry and other appropriate data to identify and analyze system and patient care trends and outcomes; Periodically conduct special studies of the Statewide trauma and specialty care systems to evaluate: System access, Capacity, Quality, Patient care outcomes, and The financial condition of the system components; Consult with appropriate persons in determining the need for trauma or specialty care services; Facilitate and, where necessary, develop and maintain, public information, education, and prevention programs as an integral component of the trauma and specialty care systems; As necessary, recommend to the EMS Board additional regulations to ensure the quality of the Statewide trauma and specialty care systems; Provide technical assistance and support to hospitals and providers as necessary to implement the components of the EMS Plan; and As necessary, verify compliance with trauma and specialty care standards by: Reviewing, inspecting, evaluating, and auditing trauma and specialty care patient records, trauma and specialty care quality improvement committee minutes, and any other documents relevant to trauma and specialty care in any trauma or specialty referral center, and Inspecting a trauma or specialty center's physical plant. With the approval of the EMS Board, MIEMSS may enter into agreements with out-of-State trauma and specialty center hospitals where necessary to ensure access of patients to appropriate levels of trauma and specialty care. Such agreements are tantamount to designation by MIEMSS and approval by the EMS Board. MIEMSS shall maintain the confidentiality of records referred to in this subtitle in accordance with: Health Occupations Article, Title 1, Subtitle 4, and §14-506, Annotated Code of Maryland; and General Provisions Article, Title 4, Subtitle 3, Annotated Code of Maryland. Education Article, §13-509, Annotated Code of Maryland Effective date: March 24, 1997 (24:6 Md. R. 488) Regulations .01—.04 amended effective July 1, 2002 (29:12 Md. R. 932) Regulation .02B amended as an emergency provision effective June 1, 2006 (33:15 Md. R. 1276); amended permanently effective October 23, 2006 (33:21 Md. R. 1678) Regulation .02B amended effective June 4, 2007 (34:11 Md. R. 972); January 13, 2011 (38:1 Md. R. 12); March 30, 2015 (42:6 Md. R. 514); July 1, 2018 (45:9 Md. R. 463); July 1, 2020 (47:5 Md. R. 313); October 3, 2022 (49:20 Md. R. 913) Regulation .03B amended effective June 4, 2007 (34:11 Md. R. 972) Regulation .04A amended effective December 19, 2005 (32:25 Md. R. 1947) Regulation .04C amended effective October 12, 2015 (42:20 Md. R. 1265) MIEMSS shall designate a hospital by level of care capability as set forth for: Trauma centers, in COMAR 30.08.05; or Specialty referral centers, in the appropriate specialty care standards within this subtitle. The levels of trauma care are: Primary Adult Resource Center; Level I trauma center; Level II trauma center; or Level III trauma center. Multiple Clinical Locations. A single hospital or one or more hospitals under common ownership may be designated as a single trauma or specialty center program with more than one clinical location if: Clinical requirements are met at each separate location; There is a designated individual with administrative oversight of the designated trauma or specialty center program; There is a designated individual with clinical oversight of the designated trauma or specialty center program who is responsible for: Data collection; Quality improvement; Education; Research; and Prevention; There is a designated individual responsible for administrative oversight at each clinical location; and There is a designated individual responsible for clinical oversight at each clinical location. In this subtitle, in the case of a designated trauma or specialty center with more than one clinical location: The term “hospital” shall be interpreted as meaning each separate clinical location which is operated as part of the designated trauma or specialty center program for the purposes of clinical requirements; and The term “hospital” shall be interpreted to mean all clinical locations operated as part of the designated trauma or specialty center program collectively for the purposes of nonclinical requirements. The EMS Board shall: Establish criteria for the number and level of trauma and specialty referral centers to be designated; and For specialty referral centers that require a certificate of need from the Maryland Health Care Commission, establish the criteria for the number of specialty referral centers in coordination with the Maryland Health Care Commission. For each region, the criteria shall address: Access to trauma or specialty care; Level of care; Capacity to provide the care; and Timeliness of care received. MIEMSS may consult with appropriate State agencies in determining the need for trauma or specialty services for a hospital's geographic service area. To be eligible for consideration by MIEMSS as a designated trauma or specialty referral center, a hospital shall meet the standards set forth for such a center in this subtitle. A hospital that is currently functioning as a trauma or specialty referral center may continue to function as a trauma or specialty referral center until MIEMSS has completed the designation process under this subtitle with respect to that hospital, if the hospital makes application for designation. The application must be received complete within 6 months of the publication date of the initial solicitation in the Maryland Register in accordance with §B of this regulation. MIEMSS shall solicit applications for trauma and specialty referral center designation from any interested hospital, including all current trauma and specialty referral centers, by publication of the solicitation in the Maryland Register. MIEMSS may periodically solicit applications for trauma and specialty referral center designation, as needed, by publication of the solicitation in the Maryland Register. MIEMSS shall provide the applicant with appropriate application materials in paper or electronic form for trauma or specialty referral center designation. An applicant for trauma or specialty referral center designation shall submit an application to the Office of Hospital Programs in a form specified by MIEMSS, which shall include, but not be limited to, submitting evidence of the applicant's financial capability to provide this care. MIEMSS shall review each application submitted for completeness. MIEMSS shall notify an applicant if an application is incomplete, and the applicant shall be afforded the opportunity to complete the application within 30 business days of the date of the notification. As necessary, MIEMSS shall provide technical assistance to a hospital throughout the designation process by answering questions about this subtitle and the designation process. An applicant's designation application is the property of MIEMSS and is confidential information in accordance with: Health Occupations Article, Title 1, Subtitle 4, and §14-506, Annotated Code of Maryland; and General Provisions Article, Title 4, Subtitle 3, Annotated Code of Maryland. MIEMSS may deny an application for designation without conducting an on-site review if it finds that the hospital: Would add unnecessary duplication of services to a geographic service area where there is not a sufficient need for additional trauma or specialty services; Is unable to meet the requirements of this subtitle for the level of designation sought; Makes a false statement or omits a material fact in the hospital records, documentation, or materials required to be submitted that pertain to the designation process; Is less qualified than another applicant hospital in the same geographic service area; Is applying for designation as a specialty center that requires a certificate of need from the Maryland Health Care Commission but does not have the required certificate of need or a waiver of the certificate of need; or Should not be designated for any other relevant reason. Notice of Denial of Application for Designation. MIEMSS shall issue a written notice of denial to the hospital. The notice of denial shall conform to State Government Article, §10-207, Annotated Code of Maryland. MIEMSS shall send the notice of denial to the chief executive officer of the hospital. MIEMSS shall notify the EMS Board of the action taken. A hospital may file an appeal with the EMS Board, in accordance with Regulation .08 of this chapter, if MIEMSS denies its application for designation. If the EMS Board overturns MIEMSS' decision to deny the application for designation, MIEMSS shall continue the application process by scheduling an on-site review of the hospital. If the hospital does not timely appeal MIEMSS' decision to deny the application for designation, MIEMSS' decision is the final agency decision and is not subject to judicial review. After a hospital's application for designation has been accepted, MIEMSS shall conduct an on-site review of a hospital that has applied to be a Primary Adult Resource Center, or a Level I, II, or III trauma center. On-Site Review Teams. MIEMSS shall establish multidisciplinary on-site review teams composed of individuals knowledgeable in trauma or specialty care and trauma or specialty care systems. The composition of the team shall be appropriate to the level of designation sought. For trauma center designation, MIEMSS shall select a team which, at a minimum, shall include MIEMSS staff and representatives from three of the following categories: Trauma surgeon; Emergency physician; Trauma nurse coordinator; Administrator. A staff person from MIEMSS shall accompany and coordinate the functions of the review team. A team shall consist of professionals who do not have any conflict or competitive interest with the applicant. If a hospital can demonstrate a reasonable basis for concern, MIEMSS shall consider allegations that conflicts of interest exist between an on-site reviewer and an applicant. Contact with Members of On-Site Review Team. Except as authorized by MIEMSS, an applicant's administration, faculty, medical staff, employees, and representatives may not have any contact with an on-site review team member relating to the review process after the team members are announced and before the on-site review is conducted. A violation of §B(7)(a) of this regulation may be grounds for denial by MIEMSS of the hospital's application. The on-site review team shall: Evaluate the appropriateness and capability of the applicant to provide trauma care services, according to the designation standards described in COMAR 30.08.05; Verify the hospital's ability to meet the: Responsibilities of, and the resources, equipment, and performance standards for, the level of designation sought, and Overall needs of the trauma system in that region; Familiarize themselves with the hospital's application and the designation standards; Inspect the hospital's physical plant; Interview trauma team members and management personnel; Examine the hospital's trauma-related documents, including patient care records; Review other materials considered appropriate by MIEMSS; Provide an exit interview of preliminary findings to the applicant upon completion of the on-site review; and Provide a brief written summary of preliminary findings upon completion of the on-site review. Confidentiality of On-Site Review Records. MIEMSS shall require and maintain confidentiality of an on-site review record. An on-site review record is confidential and exempt from public disclosure under General Provisions Article, Title 4, Subtitle 3, Annotated Code of Maryland. Except as provided in Health Occupations Article, Title 1, Subtitle 4, Annotated Code of Maryland, an on-site review record is not discoverable or admissible in evidence. A member of the on-site review team may not divulge, and may not be compelled to divulge, any information obtained or included in on-site review records submitted to MIEMSS relating to the on-site review, including in any civil action resulting from MIEMSS' designation process. Notwithstanding §§A and B of this regulation, instead of conducting an on-site review, MIEMSS may take into consideration or coordinate with verification surveys by the American College of Surgeons or other specialty medical organizations. At MIEMSS' discretion, MIEMSS may accept verification of a specialty referral center by a nationally recognized medical specialty organization, without conducting an on-site review. The on-site review process for initial designation of specialty referral centers shall be conducted in accordance with Regulation .05 of this chapter, with the following exceptions: The on-site review team shall consist of MIEMSS staff, as well as medical, administrative, and nursing professionals having expertise in the specialty being designated; The Executive Director may appoint additional staff from other State agencies to the on-site review team when those agencies have shared regulatory oversight in the specialty referral center; MIEMSS shall select a team, which, at a minimum, shall include MIEMSS staff and three representatives from the following categories: Specialty physician; Emergency physician; Specialty nurse; Administrator; The on-site review team members shall: Evaluate the appropriateness and capability of the applicant to provide specialty care services, according to the designation standards for that particular specialty, as described at COMAR 30.08.06—30.08.12; Verify the hospital's ability to meet the: Responsibilities of, and the resources, equipment, and performance standards for, the type of specialty referral center designation sought, and Overall needs of that particular specialty system in that region; Familiarize themselves with the hospital's application and the designation standards; Inspect the hospital's physical plant; Interview team members and management personnel; Examine the hospital's specialty care-related documents, including patient care records; Review other materials considered appropriate by MIEMSS; Provide an exit interview of preliminary findings to the applicant upon the completion of the on-site review; and Provide a brief written summary of preliminary findings upon the completion of the on-site review. As soon as practicable, but not later than 45 business days after completion of the on-site review, MIEMSS shall provide written notice to a hospital of its designation status. MIEMSS may: Designate the hospital as a trauma or specialty referral center as proposed by the applicant; Designate the hospital at a level of designation lower than the applicant proposed, if the on-site review determined that the hospital does not meet the standards for the level of designation proposed; Adjust the level of an applicant's designation based on system needs and the hospital's ability to meet those needs; or Deny designation as a trauma center at any level or as a specialty referral center. Provisional or Full Designation. MIEMSS may initially designate a trauma or specialty referral center as provisional on the conditions and for the provisional period, including any extensions, which MIEMSS deems appropriate; MIEMSS shall require each provisional trauma or specialty referral center to: Have a written work plan to rectify deficiencies; and Demonstrate progress on the work plan throughout the provisional period. At the end of the provisional period, including any extensions, MIEMSS may: Grant full designation to the trauma or specialty referral center; or Deny the trauma or specialty referral center's designation under §D of this regulation. MIEMSS may grant full designation to a hospital in full compliance with this chapter for a period not to exceed 5 years, excluding an extension during the reverification process as set forth in Regulation .10 of this chapter. Denial of Designation. MIEMSS may deny a hospital's designation as a trauma or specialty referral center if it finds that the hospital: Does not meet the requirements of this subtitle for the level of designation or specialty; Has engaged in unauthorized contact with an on-site review team member, as prohibited by Regulation .05B(7) of this chapter; Made a false statement or omitted a material fact in the hospital records, documentation, or materials required to be submitted that pertain to the designation process; Is less qualified than another applicant hospital in the same geographic service area; or Should not be designated for another relevant reason. Notice of Denial of Designation. MIEMSS shall issue a written notice of denial of designation to a hospital. The notice of denial of designation shall conform to State Government Article, §10-207, Annotated Code of Maryland. MIEMSS shall send the notice of denial of designation to the chief executive officer of the hospital. MIEMSS shall notify the EMS Board of the action taken. If MIEMSS approves a hospital's designation as a trauma or specialty referral center as proposed by the applicant, MIEMSS shall require the hospital to accept or decline the proposed designation within 30 business days from the date the hospital receives the notice. A hospital may file an appeal with the EMS Board in accordance with Regulation .08 of this chapter if MIEMSS: Approves the hospital at a level of designation lower than the applicant proposed; Designates the hospital as provisional; or Denies designation as a trauma center at any level or as a specialty center. If the EMS Board overturns MIEMSS' decision, MIEMSS shall designate the hospital as a trauma or specialty referral center as directed by the EMS Board. If the hospital does not timely appeal MIEMSS' decision, MIEMSS' decision is the final agency decision. Procedures for Appeal by Hospital. Not later than 20 business days from the date a hospital receives MIEMSS' decision, the hospital may appeal MIEMSS' decision by filing written exceptions with the Executive Director for consideration by the EMS Board. For the written exceptions to be considered timely, a hospital shall file the written exceptions with the Executive Director within 20 business days from the date the hospital receives MIEMSS' decision. The exceptions shall state with specificity the reasons why MIEMSS' decision should be overturned. The hospital shall mail a copy of the exceptions to MIEMSS by first class mail, postage prepaid. MIEMSS' Response. Not later than 20 business days from the date the exceptions are filed with the Executive Director, MIEMSS may file a response. MIEMSS shall mail a copy of its response to the hospital by first class mail, postage prepaid. Decision of EMS Board. Not later than 90 calendar days from the date of the filing of the hospital's exceptions or MIEMSS' response, whichever is later, the EMS Board shall issue a written decision granting or denying the exceptions. If the EMS Board denies the exceptions, the proposed decision, as affirmed by the EMS Board, is the final agency decision. If the EMS Board grants the exceptions, in whole or in part, the EMS Board shall modify the proposed decision accordingly and the modified decision is the final agency decision. An appeal to the EMS Board is not a contested case as defined in State Government Article, §10-202(d), Annotated Code of Maryland, and the decision of the EMS Board is the final agency decision and is not subject to judicial review. A designated trauma or specialty referral center: Has the right to relinquish its designation as a trauma or specialty referral center or to request a designation lower than its current level of designation; and Shall provide the Office of Hospital Programs with 90 calendar days advance written notice of its request to change its designation status. If the designated trauma center applies for a lower level of designation, MIEMSS: At its discretion, may repeat all or part of the designation process set forth in this chapter; and Shall consider the request based upon the criteria described in Regulation .02 of this chapter. Temporary Inability to Comply with Standards. A designated trauma or specialty referral center shall notify the Office of Hospital Programs within 5 business days if it is temporarily unable to comply with the requirements for designated trauma or specialty centers as set forth in COMAR 30.08.03. The notice shall be in writing and shall specify the reasons for and the anticipated duration of the temporary inability to comply with the standards. MIEMSS shall determine whether the temporary inability to comply with the standards warrants disciplinary action under COMAR 30.08.13. A designated trauma or specialty referral center, other than a designated adult or pediatric burn center, shall repeat the designation process, as set forth in this chapter, every 5 years. A designated adult or pediatric burn center shall: Complete the reverification process every 3 years; and If verified by the American Burn Association: Concurrently submit to MIEMSS the application submitted to the American Burn Association, along with such supplements as may be required by MIEMSS to demonstrate compliance with COMAR 30.08.06; and Notify MIEMSS immediately of any change in their verification status. At MIEMSS’ discretion: MIEMSS may accept verification of a trauma or specialty referral center by a nationally recognized medical specialty organization in lieu of conducting an on-site reverification review; MIEMSS may determine that there is sufficient data available to MIEMSS concerning the ongoing operation of the trauma or specialty center so that an on-site review is not necessary for a determination of reverification; or MIEMSS may conduct an on-site review for reverification with MIEMSS staff and representatives, if any, from among the categories required for an initial designation site-review team as MIEMSS deems appropriate. If a designated trauma or specialty referral center is in good standing: MIEMSS shall send written notice to the chief executive officer of the trauma or specialty referral center requesting that the trauma or specialty referral center submit, within 60 calendar days, a request for reverification of its designation status; and Designated trauma or specialty referral center shall retain its current designation status until the reverification process is completed. At the time of the reverification process, MIEMSS shall publish a notice in the Maryland Register that: Lists the trauma and specialty referral centers that have requested reverification of their designation status; Requests a person with knowledge of any reason why a designated trauma or specialty referral center should not have its designation status reverified to submit a written statement of the reason to MIEMSS within 20 business days following publication of the notice; and Requests that a hospital not designated that wishes to be considered for designation as a trauma or specialty referral center submit a written application to the Office of Hospital Programs in accordance with Regulation .03 of this chapter within 60 calendar days following publication of the notice. Education Article, §13-509, Annotated Code of Maryland Effective date: March 24, 1997 (24:6 Md. R. 488) Regulations .01—.10 amended effective July 1, 2002 (29:12 Md. R. 932) Regulation .01 amended as an emergency provision effective June 1, 2006 (33:15 Md. R. 1276); amended permanently effective October 23. 2006 (33:21 Md. R. 1678) Regulation .02D amended as an emergency provision effective June 1, 2006 (33:15 Md. R. 1276); amended permanently effective October 23. 2006 (33:21 Md. R. 1678) Regulation .03D amended effective October 3, 2011 (38:20 Md. R. 1205) Regulation .03I amended effective December 19, 2005 (32:25 Md. R. 1947); October 12, 2015 (42:20 Md. R. 1265) Regulation .04A amended effective October 3, 2011 (38:20 Md. R. 1205) Regulation .05B amended effective December 19, 2005 (32:25 Md. R. 1947); October 12, 2015 (42:20 Md. R. 1265) Regulation .07C, G amended effective October 3, 2011 (38:20 Md. R. 1205) Regulation .10 amended effective October 3, 2011 (38:20 Md. R. 1205); July 1, 2020 (47:5 Md. R. 313) A hospital designated as a trauma or specialty referral center shall: Comply with the applicable standards for trauma or specialty care as developed by MIEMSS and set forth in COMAR 30.08.05—30.08.12; Receive all trauma or specialty patients, regardless of race, color, religion, age, sex, marital status, national origin, ancestry, physical or mental disability, or ability to pay; Upon MIEMSS' request, provide data to MIEMSS related to trauma or specialty care programs; Allow MIEMSS to monitor compliance with applicable regulations and standards as set forth by MIEMSS, including providing MIEMSS with access to: Patient discharge summaries, Patient care logs, Patient care records, Hospital trauma or specialty care quality management program records, including minutes, and Other documents that MIEMSS determines to be relevant; and Require confidentiality of information relating to an individual patient, provider, and hospital care outcomes in accordance with: Health Occupations Article, Title 1, Subtitle 4, Annotated Code of Maryland, and General Provisions Article, Title 4, Subtitle 3, Annotated Code of Maryland. Emergency Standards. MIEMSS may impose additional requirements on a trauma or specialty referral center if it determines that the requirements are necessary for the immediate protection of trauma or specialty patients. MIEMSS shall provide the designated trauma or specialty referral center with advance written notice of an additional emergency standard. The designated trauma or specialty referral center shall have reasonable time to comply with the emergency standard. MIEMSS shall develop and distribute to health care providers prehospital triage and transport protocols for patients needing trauma or specialty referral services to ensure that patients who meet the triage criteria established by the protocols are transported directly to an appropriate facility. In the absence of extenuating circumstances, a health care provider shall transport a patient to the closest appropriate trauma or specialty referral center, consistent with the triage protocols. A hospital may not represent itself to be a trauma or specialty referral center unless it is so designated by MIEMSS and approved by the EMS Board. A designated trauma or specialty referral center may not advertise services or capabilities for the treatment of patients above the trauma care level or specialty for which it has been designated. Education Article, §13-509, Annotated Code of Maryland Effective date: March 24, 1997 (24:6 Md. R. 488) Regulations .01—.03 amended effective July 1, 2002 (29:12 Md. R. 932) Regulation .01 amended as an emergency provision effective June 1, 2006 (33:15 Md. R. 1276); amended permanently effective October 23, 2006 (33:21 Md. R. 1678) Regulation .01A amended effective December 19, 2005 (32:25 Md. R. 1947); October 12, 2015 (42:20 Md. R. 1265) MIEMSS shall: Maintain the State trauma registry to collect and analyze data including, but not limited to, data concerning the incidence, severity, and causes of trauma and burns; Establish criteria to identify patients to be included in the State trauma registry; Collect data about patients to be included in the State trauma registry from: EMS providers; Hospitals, both designated and nondesignated including, but not limited to: The primary adult resource center; Level I trauma centers; Level II trauma centers; Level III trauma centers; and Maryland Trauma Specialty Referral Centers as defined in Health-General Article, §19-130(a)(3), Annotated Code of Maryland; Office of Medical Examiner reports; and Other sources outside of the trauma and specialty care systems including, but not limited to: Death certificates, Hospital inpatient discharge data, Health care provider and third-party payer billing data, and Law enforcement agency records; Require hospitals to have a case specific patient identifier common to all data sources used in the State trauma registry; and Establish procedures and specifications for electronic and hard copy submission of data. MIEMSS shall design a trauma and specialty care quality management plan for continued monitoring and evaluation of the State trauma and specialty care systems. The trauma and specialty care quality management plan shall include the establishment, publication, and periodic review of the data required to be submitted to provide information regarding injury, trauma and specialty care, and system operation in the following categories: Demography; Anatomy; Physiology; Severity; Epidemiology; Resource utilization; Quality improvement; Outcomes; and Finance. MIEMSS shall establish committees for trauma and specialty care quality management as structural units of the Maryland EMS Quality Leadership Council to coordinate the trauma and specialty care systems quality management and quality improvement activities set forth in this subtitle. MIEMSS shall develop a system and reporting mechanism for quality improvement by: Determining the data standards for the State trauma registry; Setting forth the data standards for the State trauma registry in: The Maryland State Trauma Registry Data Dictionary for Adult Patients for patients 15 years old and older; and The Maryland State Trauma Registry Data Dictionary for Pediatric Patients for patients younger than 15 years old. Establishing protocols for quality monitoring, consistent with MIEMSS' most current data quality guidelines; Conducting studies to assess the completeness and accuracy of case identification and data collection; and Ensuring that the data entered in the State trauma registry is complete and accurate. A designated trauma or specialty referral center shall have a hospital-wide quality management plan to reflect and demonstrate continuous quality improvement in the delivery of trauma and specialty care. The quality management program includes, but is not limited to, the requirements for trauma and specialty referral centers in COMAR 30.08.03. A designated trauma and specialty referral center shall have a system for continuous monitoring and trend analysis of trauma patient bypass status. Designated trauma and specialty referral centers shall participate in State trauma and specialty care quality management activities sponsored by MIEMSS. If appropriate for quality assurance purposes, designated trauma and specialty centers shall provide EMS providers licensed or certified by the EMS Board under Education Article §13-516, Annotated Code of Maryland, who have or have had a direct treatment relationship with a patient, follow-up data or information on that patient. Quality assurance information provided under this action is considered to be provided in accordance with COMAR 30.03.04.05. MIEMSS may use State trauma registry and specialty care data to: Monitor and provide information necessary to evaluate major trauma or specialty patient care, outcome, and cost; Assess compliance of EMS providers, designated trauma and specialty referral centers, and other hospitals with the trauma and specialty care standards, regulations, and protocols; Provide information necessary for resource planning and management; Provide data for injury surveillance, analysis, and prevention programs; and Provide a data resource for research and education. Prehospital services shall provide prehospital MAIS runsheets or EMAIS patient care reports that include trauma or specialty care patient data about: Trauma victims dead at the scene of the trauma; Patients meeting State trauma or specialty triage criteria who are transported to a hospital; Patients transported in accordance with interfacility transfer policies to receive a higher level of care or for special resources; and Patients transported to specialty referral centers. The transporting service is responsible for submitting patient care data designated in the MAIS runsheet or the EMAIS patient care report to the receiving hospital. Designated trauma or specialty care centers shall use the patient criteria described in Regulation .01B and C of this chapter. Data that identifies individual patients, providers, and hospital outcomes is confidential. MIEMSS may only release confidential information: As required by the Health Services Cost Review Commission under Health-General Article, §19-130, Annotated Code of Maryland; or In accordance with: The provisions of Health Occupations Article, Title 1, Subtitle 4, and §14-506, Annotated Code of Maryland; and Other criteria as developed by MIEMSS pertaining to patient confidentiality and quality management records. MIEMSS may approve requests for data and other information from the State trauma registry and specialty care databases for special studies and analyses in accordance with §B of this regulation. A person having access to information collected under this subtitle may use the information only for the purposes allowed under Regulation .04 of this chapter. MIEMSS may require a person who requests data or other information from the State trauma registry and specialty care databases to pay all or part of the reasonable costs associated with special preparation of the request. MIEMSS may not disclose confidential information to any person, except on request: To an approved regional or State quality improvement program if the regional or State quality improvement program is subject to the same confidentiality guidelines as MIEMSS; To a scientific research professional associated with a scientific research organization, if: MIEMSS has reviewed and approved the research professional's written research proposal with respect to scientific merit and confidentiality safeguards, and The data does not identify specific hospitals or patients; and MIEMSS shall provide aggregate State trauma registry and specialty care data to hospitals, public or private agencies, and other interested parties for: Prevention activities, Epidemiological or demographic studies, or Education and research projects. Education Article, §13-509, Annotated Code of Maryland Effective date: March 24, 1997 (24:6 Md. R. 488) Regulations .01—.04 amended effective July 1, 2002 (29:12 Md. R. 932) Regulation .01 amended effective June 4, 2007 (34:11 Md. R. 972) Regulation .02D amended effective June 4, 2007 (34:11 Md. R. 972) Regulation .03E adopted effective December 15, 2003 (30:24 Md. R. 1746) Regulation .05 amended effective June 4, 2007 (34:11 Md. R. 972) Regulation .06 amended effective July 1, 2002 (29:12 Md. R. 932); December 19, 2005 (32:25 Md. R. 1947) In this chapter, the following terms have the meanings indicated. Terms Defined. “E” means the standard is essential. “D” means the standard is desirable. “NA” means the standard does not apply. “PARC” is a Primary Adult Resource Center. “I” is a Level I trauma center. “II” is a Level II trauma center. “III” is a Level III trauma center. “ED” is an emergency department for which the indicated standards are recommended, not required. PARC I II III ED A. A hospital’s board of directors, administration, and medical and nursing staffs shall demonstrate commitment to the optimal care of injured patients by: (1) Formulating a board of director’s resolution stating that: E E E E E (a) The hospital agrees to meet the Trauma Center designation standards for the hospital’s specific level of designation; E E E E E (b) The hospital has a commitment to the infrastructure and the financial, human, and physical resources necessary to support the hospital’s specific level of designation; and E E E E E (c) The hospital has a commitment to the Quality Management (QM) process of the trauma patient; and E E E E E (2) Establishing an identifiable program whose dedication to the care of the injured is shown in: (a) Its mission statement; E E E E NA (b) The configuration of its medical, administrative, and support staffs; E E E E NA (c) The configuration of its physical plant; E E E E NA (d) Demonstrated participation and involvement in state and regional trauma system planning, development, and operations required for all designated Trauma Centers; E E E E E (e) Assurance that all trauma patients receive medical care commensurate with the level of the hospital’s designation; and E E E E E (f) Demonstrated commitment to the infrastructure and financial, human, and physical resources necessary to support the hospital’s level of trauma center designation through the hospital’s bylaws, contracts, and budget specific to the trauma program; E E E E E B. A hospital shall be licensed by the Department of Health as an acute care hospital. E E E E E C. A hospital shall 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. E E E E E D. A hospital shall maintain current equipment and technology to support optimal trauma care for the level of the hospital’s Trauma Center designation. E E E E E E. A hospital shall have: (1) A heliport or helipad positioned so there is a limited distance from the helipad to the hospital, and positioned at the closest safe location, in order to minimize effects to the patient; or E E E E NA (2) Access to a helicopter-landing zone near the hospital. NA NA NA NA E F. To administer the trauma program, a hospital shall have a trauma leadership team that includes: (1) A Trauma Medical Director (TMD) who: E E E E D (a) Has administrative oversight for the trauma program; (b) With the Trauma Program Manager (TPM), has the authority and is empowered by the hospital’s governing body to lead the trauma program; (c) Has the authority and scope for administering all aspects of trauma care and is responsible for overall clinical coordination; (d) Is responsible for all trauma patients through the QM process; (e) Directs the Trauma QM Program and reports QM activity as directed by the institutional reporting structure; (f) Has a job description developed by the hospital to reflect the role and responsibilities as defined by COMAR; (g) Appears on the hospital’s organizational chart where the relationship between the medical director and other hospital services are depicted and delineated; and (h) Participates in regional and state education, QM, and injury prevention activities; (2) A full-time director of patient care services, who is a registered nurse, with direct authority for all nursing and ancillary trauma patient care services, operations, and the QM associated with these services; E NA NA NA NA (3) An in-house resource coordinator who is available 24 hours a day and is responsible for the timely coordination of trauma patient care resources, services, patient flow and throughput; E E E E E (4) A TPM who is dedicated full-time to the management of the trauma program and in collaboration with the TMD and nursing management, has oversight for, monitors, and coordinates the components of the trauma program, including: E E E E NA (a) Patient care; (b) Provider education; (c) Public education and prevention activities; (d) Program management; (e) The hospital’s participation in the Maryland State Trauma Registry; (f) QM for the trauma program; and (g) Show evidence of 16 hours of external 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; G. The Trauma Center shall have one or more committees that provide expert input to the hospital’s management of trauma program issues that shall: (1) Under the leadership of the TMD and TPM or designee, provide trauma multidisciplinary peer review and include representatives from general surgery, to address clinical care issues; E E E E NA (2) Conduct trauma multidisciplinary peer review that includes Orthopedic surgery, Emergency Medicine, Critical Care, Anesthesia, Neurosurgery, Radiology and Nursing, to address clinical care issues; E E E E E (3) Monitor trauma patient care among hospital departments, medical and nursing staffs, and representative disciplines across the trauma care continuum; and E E E E NA (4) Collaborate with the Emergency Department (ED) Committee to address trauma care issues. NA E E E E H. The Trauma Resuscitation Team shall: (1) Be in the Trauma Resuscitation Unit on arrival for all trauma patients; E NA NA NA NA (2) Be in the trauma resuscitation area at the bedside within 15 minutes of being called for the highest level of activation; NA E E NA NA (3) Be activated by an emergency physician or nurse using clearly defined Trauma Center criteria for activation protocol; NA E E E E (4) Be directed by an in-house emergency physician who has experience and training in trauma resuscitation until the patient is formally transferred to the care of the trauma surgeon; NA E E E E (5) Be in the trauma resuscitation area at the bedside within 30 minutes of being called for the highest level of activation; NA NA NA E D (6) Be oriented to the trauma care system; E E E E D (7) Be required to complete annual continuing education and demonstrate competence for trauma care that is appropriate and specific to each member’s specialty roles; E E E E E (8) Participate in: (a) Trauma Quality Management (QM); and E E E E E (b) Ongoing medical education or continuing education in trauma; E E E E E (9) Be oriented to the internal trauma patient clinical management protocols or clinical practice guidelines, and algorithms derived from evidenced-based validated resources; E E E E E (10) Be defined in writing, specifying the roles and responsibilities of each member; and E E E E E (11) Be accountable to the trauma surgeon who becomes the team leader upon arrival in the resuscitation area. NA E E E NA I. A hospital shall have written policies and procedures to direct the organized, safe, intra-hospital and inter-hospital transfer process of trauma patients. E E E E E J. A hospital shall 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. E E E E E K. A hospital shall 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. E E E E E L. A hospital shall have a multidisciplinary plan of care specific to the needs of each trauma patient and address all phases of care, including discharge disposition, and rehabilitation needs. E E E E NA PARC I II III ED A. Credentialing Process. Each physician and Advanced Practice Professional (APP) shall be credentialed by the hospital for the appropriate specialty, including trauma care. E E E E E B. Delineation or Reevaluation of Privileges: E E E E NA (1) The trauma physicians and APPs shall be limited to those with demonstrated skills, commitment, experiences, and interest in trauma care. E E E E NA (2) The trauma medical director shall serve on the medical staff as the trauma chief of service. E E E E NA (3) Appointment and reappointment to the trauma admitting or consulting staff shall be coordinated by the trauma medical director and based on the following criteria: E E E E NA (a) Maintenance of good standing in the primary specialty; E E E E NA (b) Evidence of the required continuing medical education in trauma, including: (i) For general surgeons taking trauma calls evidence of 16 hours of trauma-related CME credits a year; E E E E NA (ii) Over a 2-year period, half of the CME hours shall be obtained outside the hospital and be recognized by a national accrediting body; E E D D NA (iii) ATLSTM which may be counted in required CME credits; and E E E E NA (iv) Physician CME credits shall be documented in accordance with hospital policy. E E E E NA (c) Documented attendance at Trauma QM meetings, as those meetings are institutionally defined, of no less than monthly averaged over 12 months; E NA NA NA NA (d) Documented attendance at Trauma multidisciplinary meetings, Morbidity and Mortality (MandM) rounds, or hospital peer-review conference that deal with the care of injured patients; and NA E E E NA (e) Satisfactory performance in managing trauma patients based on performance assessment and outcome analysis. E E E E NA PARC I II III ED Trauma Service requirements are as follows: A. The Trauma Service shall be established by the medical staff and shall be responsible for the care of injured patients. E E E E NA B. Privileges for physicians on the trauma service shall be determined by the medical credentialing process. E E E E NA C. The trauma service attending surgeon shall retain responsibility for the patient and coordinate all therapeutic decisions while the patient is on the Trauma Service. E E E E NA D. Injured patients may be observed by or admitted to an individual surgeon, but the structure of the program shall allow the Trauma Medical Director to have oversight authority for the care of these patients. E E E E NA E. The Trauma Center shall have a clearly defined response requirement for the trauma surgical evaluation of injured patients. E E E E NA F. Patients with injuries having a high index of suspicion, such as a significant mechanism of injury, shall be evaluated by the trauma service in compliance with hospital protocol. E E E E NA G. The emergency physician may initially evaluate the trauma patient, but the Trauma Center shall have a clearly defined response requirement for the trauma surgical evaluation of those patients requiring observation or admission. NA E E E E H. Patients with multiple system or complex single system injuries shall be evaluated by the trauma surgery service. E E E E NA I. The surgeon responsible for a patient’s care shall be identified. E E E E NA J. The hospital shall document: (1) Current certification as ATLS® instructors for all attending general trauma surgeons; E NA NA NA NA (2) Successful completion and continued certification of an ATLS® course for all general trauma surgeons; E E E D NA (3) Successful completion and continued certification of an ATLS® course for the TMD and all APP’s who provide initial evaluation of trauma patients, treatment and care; and E E E E E (4) Current APLS® certification for physicians providing pediatric trauma care; D D D D D PARC I II III ED The Trauma Medical Director (TMD) shall: A. Be an expert in and committed to the care of the injured with a special interest in trauma care; E E E E NA B. Be board certified in general surgery or other surgical specialties; E E E E NA C. Be able to devote the time needed to fulfill the TMD responsibilities as delineated in COMAR; E E E D NA D. Have the following educational preparation and clinical experience: (1) Successful completion of advanced specialty training in trauma care or Trauma/Critical Care fellowship for at least 1 year; E E E D NA (2) Demonstrated experience at a designated Level I Trauma Center in trauma systems management, trauma research, and quality management functions; and E D NA NA NA (3) Documented interest in trauma center or trauma system issues as evidenced by education, publications, professional experience, and involvement in planning and prevention efforts; E D D D NA E. Maintain membership and active participation in local, regional, state or national trauma-related activities and trauma organizations; E E E E NA F. Participate in trauma educational activities such as: (1) Trauma/Critical Care fellowship programs; E D NA NA NA (2) Undergraduate medical education; E E NA NA NA (3) Continuing education; and E E E E NA (4) ATLS® courses; E E E E NA G. Participate in trauma research and publication efforts; and E E D D NA H. Demonstrate active participation in the resuscitation of multi system trauma patients, or surgery of multi system trauma patients or both. E E E E NA PARC I II III ED A. General Surgery. A hospital shall have a surgery department including: (1) For the “most critical patients” an in-house, fellowship trained attending trauma surgeon, trauma fellow or trauma fellow equivalent/PGY5+ general surgery resident should be at the bedside upon arrival, documented at least 80 percent of the time. E NA NA NA NA (2) Either: (a) A trauma or general surgeon trained in trauma care who shall be at the bedside within 15 minutes of being called for the highest level of activation and should be at the bedside within 15 minutes with compliance demonstrated at least 80 percent of the time; NA E E NA NA (b) An in-house PGY4 or more senior resident who shall be at the bedside with the attending trauma or general surgeon within 15 minutes of being called for the highest level of activation and should be at the bedside within 15 minutes with compliance demonstrated at least 80 percent of the time; or NA E E NA NA (c) An in-house APP trained in trauma care who shall be at the bedside with the attending trauma or general surgeon within 15 minutes of being called for the highest level of activation and should be at the bedside within 15 minutes with compliance demonstrated at least 80 percent of the time; NA E E D NA (3) An attending trauma surgeon taking trauma call who shall be at the bedside within 30 minutes from patient arrival for the highest level of activation with the surgeons’ presence with compliance demonstrated at least 80 percent of the time; NA NA NA E NA (4) Trauma or general surgeons who are board certified or board eligible, E E E E NA (5) Trauma or general surgeons who agree to actively participate in a defined continuing education program; E E E E D (6) Criteria and protocols for the notification and response of a trauma or general surgeon; E E E E NA (7) General Surgery APPs taking trauma call who have evidence of average of 16 hours a year or 32 hours in 2 years of trauma-related education; and E E E E NA (8) A liaison to the trauma QM program with 50 percent attendance. E E E E NA B. Neurosurgery. Neurosurgery requirements are as follows: (1) Neurosurgeons who are board certified or board eligible; E E E E E (2) A Board-certified or board-eligible, trauma fellowship-trained in-house neurosurgery attending or PGY2 or higher, dedicated 24 hours a day to trauma care with a Neurosurgery Attending on-call and who shall be at the patient bedside within 30 minutes after Emergent consultation has been requested by the trauma team leader for injured patients based on institution-specific criteria; E E NA NA NA (3) The on-call Neurosurgery Attending taking trauma call shall be at the bedside within 30 minutes after Emergent consultation has been requested by the trauma team leader for injured patients based on institution-specific criteria and with in-house physician capable of initiating stabilization and diagnostic procedures; NA NA E E NA (4) If a neurosurgeon taking trauma call covers more than one hospital within the same geographic area, there shall be a written contingency plan in place for times in which a neurosurgeon is unavailable upon the arrival of a Neurotrauma case; NA NA E E E (5) A qualified Neurosurgeon shall be regularly involved in the care of patients with neurologic injuries and shall be credentialed by the hospital with general neurosurgical privileges; E E E E E (6) Neurosurgery APP or PGY2 or higher with attending on-call; NA NA E E E (7) Neurosurgery APPs taking trauma call shall have evidence of average of 16 hours a year or 32 hours in 2 years of trauma-related education; and E E E E NA (8) A liaison to the trauma QM program with 50 percent attendance. E E E E NA C. Orthopedic Surgery. Orthopedic surgery requirements are as follows: (1) A Board-certified or board-eligible, trauma fellowship-trained in-house orthopedic attending or PGY2 or higher, dedicated 24 hours a day to trauma care with an Orthopedic Attending on-call and who shall be at the patient bedside within 30 minutes after Emergent consultation has been requested by the trauma team leader for injured patients based on institution-specific criteria; E E NA NA NA (2) Orthopedic team members shall have dedicated call at their institution or have an effective backup call system. If the on-call orthopedic surgeon is able to respond promptly, a backup consultant on-call surgeon shall be available; E E E E E (3) Board-certified or board-eligible on-call attending with a 30-minute response after emergent response is requested; NA NA E E NA (4) Orthopedic APPs taking trauma call who have evidence of average of 16 hours a year or 32 hours in 2 years of trauma-related education; and E E E E NA (5) A liaison to the trauma QM program with 50 percent attendance. E E E E NA PARC I II III ED A. Anesthesia. Anesthesia requirements are as follows: (1) Board-certified, fellowship trained Anesthesiology Attending in-house, dedicated 24 hours a day to trauma care should be at the bedside upon arrival, and documented at least 80 percent of the time; E NA NA NA NA (2) Board-certified or board-eligible, in-house attending 24 hours a day; NA E E E NA (3) Attending anesthesiologist or CRNA taking trauma call shall be at the bedside within 15 minutes of being called with institution-specific criteria defining conditions requiring an immediate response, and present for all operations; and NA E E E NA (4) A liaison to the trauma QM program with 50 percent attendance. E E E E E B. Emergency Medicine. Emergency Medicine (EM) requirements are as follows: (1) Physician Director or designated Director of Trauma Services in Emergency Medicine who: (a) Is Board certified or board eligible in EM with evidence of active participation in daily emergency care; NA E E E D (b) Has administrative duties in the Emergency Department (ED); NA E E E D (c) Demonstrates the successful completion of the ATLS® course, at least once; and NA E E E E (d) Maintains ATLS® certification; NA E E E E (2) Emergency physician in-house 24 hours a day who is: (a) Board certified or board eligible in EM; NA E E E E (b) Board certified or board eligible in a non-EM specialty with at least 7,000 hours of emergency practice and current ATLS® certification; NA NA NA E E (c) If certified by boards other than EM and treating trauma patients in the ED, current ATLS® status; or NA E E E E (d) Has demonstrated special capabilities through commitment, continuing education, and experience; NA NA NA NA E (3) Advanced Practice Professionals (APP) providing care to the trauma patient who have current ATLS® certification; and NA E E E E (4) A liaison to the trauma QM program with 50 percent attendance. NA E E E E C. Critical Care. Critical care requirements are as follows: (1) Intensive care with a designated surgical director who is fellowship trained and board certified in surgery or critical care; E E D NA NA (2) A board certified surgeon who serves as director or co-director of the ICU and is actively involved in, and responsible for, setting policies and administrative decisions related to trauma ICU patients; NA NA E D NA (3) A trauma surgeon who retains responsibility for the patient and coordinates all therapeutic decisions; NA E E E NA (4) If Telemedicine is used, physician/s who have privileges in critical care and be approved by the TMD; and E E E E NA (5) A liaison to the trauma QM program with 50 percent attendance. E E E E NA The following surgical specialties shall be on call and available with a 30-minute response time: PARC I II III ED A. Cardiac; E E D NA NA B. Hand; E E D D NA C. Microvascular replant or flaps; E E D D NA D. Obstetric and gynecologic; E E E E NA E. Ophthalmic; E E E D NA F. Oral or maxillofacial; E E E D NA G. Otorhinolaryngologic; E E E D NA H. Pediatric; E E D D NA I. Plastic; E E E D NA J. Thoracic; E E E E NA K. Urologic; and E E E E NA L. Vascular. E E E D NA PARC I II III ED The following non-surgical 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 surgical trauma team leader based on institution-specific criteria: A. Cardiology; E E E E D B. Pulmonary medicine; E E E E D C. Interventional Radiology (perform complex imaging studies, or interventional procedures); E E E D NA D. Interventional Angiography; and E E E D D E. Pediatrics. E E D D NA PARC I II III ED The following non-surgical specialties shall be on-call: A. Gastroenterology; E E E D NA B. Infectious Disease; E E E D NA C. Internal Medicine; E E E E D D. Nephrology; E E E E D E. Neurology; E E E E NA F. Pathology; E E E E NA G. Physiatry; and D D D D NA H. Psychiatry. E E E E D PARC I II III ED A. Responsibility shall be assigned within the department of nursing for trauma care. Oversight of trauma nursing care services shall be with the Department of Nursing. NA E E E NA B. A written plan shall exist and be approved by nursing that shall include the ability to immediately mobilize qualified staff for initial resuscitation. E E E E E C. There shall be a written plan for providing adequate and appropriate nursing staff to meet the acuity needs of trauma patients in each unit. E E E E E D. The nursing department shall participate in multidisciplinary quality management monitoring of trauma care. E E E E E E. There shall be an introductory education program for all nurses caring for Trauma patients that addresses the learning outcomes approved by the Maryland Trauma Quality Improvement Committee (TQIC). This introductory education program shall include 16 hours of content within 1 year of hire. E E E E E F. After completion of the introductory education mandated in this regulation, continuing education shall be current, meeting the following requirements: E E E E D (1) 8 hours of trauma-related education every year for emergency and critical care, OR, and PACU nurses caring for trauma patients; or (2) 4 hours of trauma-related education every year for nurses caring for trauma patients and are from other clinical areas. PARC I II III ED A. Emergency Department. Emergency Department (ED) requirements are as follows: (1) A designated ED physician director and nurse manager; NA E E E E (2) Board-certified or board-eligible attending physician with demonstrated competence in the care of critically injured patients in-house 24 hours a day; NA E E E D (3) A dedicated Trauma Resuscitation Unit (TRU) with dedicated staff, equipment and supplies 24 hours a day; E NA NA NA NA (4) Dedicated trauma resuscitation area with dedicated staff, equipment, and supplies 24 hours a day; NA E E E E (5) Senior attending trauma surgeon available 24 hours a day through EMRC/SYSCOM as a resource for trauma consultation Statewide; E NA NA NA (6) A sufficient number of registered nurses and other providers, who are competent to provide care during trauma resuscitation and present in sufficient numbers to manage projected case load, and a plan to reinforce the number of staff on immediate notice of multiple admissions; E E E E E (7) Defined and agreed on roles and responsibilities approved by the TMD with the overall goal to have available ED resources needed to care for patients; NA E E E E (8) Verification of functioning life-safety emergency equipment and supplies organized for trauma resuscitation present and immediately available 24 hours a day; E E E E E (9) Direct communication link to pre hospital providers and transport vehicles; E E E E E (10) Designated as Base Station by MIEMSS; E E E E E (11) Emergency Equipment located in the Resuscitation area/ED for: E E E E E (a) Airway control or cricothyrotomy; E E E E E (b) Difficult Airway Equipment; E E E E E (c) Thoracotomy; E E E E E (d) Vascular access; E E E E E (e) Thoracostomy/Chest decompression; E E E E E (f) Peritoneal Lavage; E E E E E (g) Bedside Ultrasound; E E E E E (h) Extremity Hemorrhage Control devises/Tourniquet; E E E E E (i) Rapid Infuser and Warmer; and E E E E E (j) Access to compartment measurement device; E E E E E (12) Policies and protocols for trauma team response and roles in ED trauma resuscitation in accordance with Regulation .11 of this chapter; and E E E E E (13) Drugs necessary for emergency care; E E E E E B. Operating Room. Operating Room (OR) requirements are as follows: (1) OR rooms adequately staffed with in-house personnel dedicated to trauma 24 hours a day; E D NA NA NA (2) OR available within 15 minutes of notification with adequate in-house staff; E E E E NA (3) X-ray capability including C-arm image intensifier 24 hours a day; E E E E NA (4) Equipment and instrumentation appropriate for: (a) Neurosurgery; E E E E NA (b) Vascular surgery; E E E E NA (c) Pelvic and long-bone fracture fixation; and E E E E NA (d) Cardiopulmonary bypass: (i) Cardiopulmonary bypass; E E D NA NA (ii) If cardiopulmonary bypass equipment is not immediately available, a written contingency plan, including immediate patient transfer to an appropriate center with a 100 percent performance improvement review of all patients transferred; NA E E E NA (5) Rapid fluid infusers, thermal control equipment for patients and resuscitation fluids, intraoperative radiologic capabilities, equipment for fracture fixation, and equipment for bronchoscopy and gastrointestinal endoscopy; E E E E NA (6) Equipment for continuous monitoring of temperature, hemodynamics, and gas exchange; and E E E E NA (7) Endoscopes. E E E E NA C. Post-Anesthesia Care Unit (PACU) requirements are as follows: (1) Dedicated to trauma and staffed 24 hours a day; E NA NA NA NA (2) PACU Room/s available to trauma patients with registered nurses and other essential staff 24 hours a day; and NA E E E NA (3) The necessary equipment to monitor and resuscitate patients including equipment for continuous monitoring of temperature, hemodynamics, and gas exchange. E E E E NA D. Intensive Care Unit (ICU). Intensive care unit requirements are as follows: (1) Dedicated ICU for trauma with appropriately trained registered nurse staff; E NA NA NA NA (2) Designated ICU bed availability for trauma patients with appropriately trained trauma registered nurses in sufficient numbers based on patient acuity; E E E E NA (3) Written plan for triaging patients from the intensive care unit to free up beds for trauma patients when necessary or provision of alternate critical care beds for trauma patients with appropriately trained registered nurse staff; E E E E NA (4) The means to ensure that the trauma surgeon is kept informed and concurs with major therapeutic and management decisions made by the ICU team which can collaboratively manage many of the daily care requirements; E E E E NA (5) The means to ensure that trauma patients are not admitted or transferred by a primary care physician without the knowledge and consent of the trauma service; E E E E NA (6) The necessary equipment to monitor and resuscitate patients; E E E E NA (7) Support services with immediate access to clinical diagnostic services such as arterial blood gases, hematocrits, and chest X-rays available within 30 minutes; E E E E NA (8) A Respiratory Therapist available in the hospital 24 hours per day; E E E E E (9) Nutrition support services available; and E E E E NA (10) Acute continuous hemodialysis capability. E E E E NA E. Acute Spinal Cord and Head Injury Management Capability. Acute spinal cord or head injury management requirements are as follows: (1) Dedicated Neurotrauma units with dedicated, specialty trained nursing and support staff; E NA NA NA NA (2) Neuro-intensive services with intracranial pressure capabilities for trauma patients; NA E D D NA (3) Intracranial pressure monitoring equipment available with neurosurgical coverage; E E E E E (4) Dedicated services to care for spinal cord injury and patient management; and E NA NA NA NA (5) Orthopedics or Neurosurgery management of the spine patients with appropriate neuro monitoring consistent with current standards of care to meet the needs of the patient. E E E E E F. Burn Care. Burn care requirements are as follows: (1) Ability to provide initial resuscitation for burn patients; E E E E E (2) Proper equipment for the care of burned patients, prior to transfer to burn center; and E E E E E (3) A hospital shall 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. E E E E E (4) A hospital shall 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. E E E E E G. Radiological Special Capabilities. Radiological special capabilities requirements are as follows: (1) Qualified radiologists and staff available within 60 minutes of consultation notification to perform complex imaging studies, or interventional procedures; E E E E E (2) A Board-certified or board-eligible, in-house Radiology Attending on-call who shall provide interpretations of radiographs within 30 minutes; E NA NA NA NA (3) Qualified in-house Radiology or Teleradiology available 24 hours a day for the interpretations of radiographs; NA E E E E (4) Changes in interpretation between preliminary and final reports, as well as missed injuries, monitored through the QM program; E E E E NA (5) A mechanism in place to view radiographic imaging from referring hospitals; E D D D NA (6) In-house trauma-dedicated technicians 24 hours a day; E NA NA NA NA (7) In-house radiology technicians 24 hours a day; E E E E E (8) Dedicated computed tomography (CT) scan and angiography facilities and staff 24 hours a day; E NA NA NA NA (9) Interventional Angiography; E E E D NA (10) Sonography; E E E E D (11) Nuclear scanning; E E E E NA (12) Magnetic resonance imaging (MRI) capability available 24 hours per day; E E E D D (13) An MRI technologist who may respond from outside the hospital with the QM program documenting and reviewing arrival within 60 minutes of being called; and E E E D D (14) Computed tomography (CT): (a) Computed tomography (CT) in-house and available 24 hours a day; E E E E NA (b) In-house CT technician 24 hours a day; and E E E E NA (c) Back-up CT scan capabilities. E E E E NA H. Rehabilitation. Rehabilitation requirements are as follows: (1) Rehabilitation services staffed by personnel trained in rehabilitative care and properly equipped for acute care of the critically injured patient; E E D D NA (2) Rehabilitation consultation services, occupational therapy, speech therapy, physical therapy, and social services available in the critical care phase as needed; E E D D NA (3) Full in-house service or transfer process in place to a rehabilitation service for Long-term care or sub-acute care; E E E E NA (4) Ongoing continuity of care for patients with traumatic brain, musculoskeletal, and soft tissue injuries provided in affiliated rehabilitation facility by attending trauma center specialists and sub-specialists; and E NA NA NA NA (5) 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. E E E E NA I. Clinical Laboratory Service. (1) A clinical laboratory service shall be available 24 hours a day capable of providing: E E E E E (a) Standard analysis of blood, urine, and other body fluids; (b) Blood-typing and cross-matching; (c) 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; (d) Blood gases and pH determinations; (e) Coagulation studies; (f) Microbiology; and (g) Drug and alcohol screening. (2) The blood bank shall have an adequate in-house supply of red blood cells, fresh frozen plasma, platelets, cryoprecipitate, and appropriate coagulation factors to meet the needs of injured patients. E E E E E (3) A massive transfusion protocol developed collaboratively between the trauma service and the blood bank. E E E E E (4) A dedicated satellite lab or Point-of-Care available near or in the trauma resuscitation area for essential lab studies. E E D D NA J. Equipment for Resuscitation. Equipment for resuscitation of patients of all Ages in the ED, OR, PACU, and ICU shall be immediately available and include: (1) Airway control and ventilation equipment, difficult airway equipment, including laryngoscopes and endotracheal tubes of all sizes, bag-mask resuscitator, pocket masks, and oxygen; E E E E E (2) Suction devices; E E E E E (3) Pulse oximetry; E E E E E (4) Electrocardiograph-oscilloscope-defibrillator; E E E E E (5) Standard intravenous fluids and administration devices, including large-bore intravenous catheters; E E E E E (6) End-tidal CO2 determination; E E E E E (7) Apparatus to establish hemodynamic monitoring; E E E E NA (8) Skeletal traction devices, including capabilities for cervical traction; E E E E E (9) Arterial catheters; E E E E NA (10) Thermal control equipment for patient and fluids; E E E E E (11) Rapid Infuser and Warmer; E E E E E (12) Compartmental pressure measuring device; and E E E E D (13) Portable ultrasound. E E E E E PARC I II III ED A. The ongoing Quality Management (QM) of the trauma program shall be: E E E E E (1) Integrated into the hospital’s overall quality management program; and E E E E E (2) Reported to the hospital’s governing body. E E E E E B. Trauma Centers shall have: (1) A QM comprehensive written plan outlining the configuration and identifying both adequate personnel to implement that plan and an operational data management system: and E E E E E (2) A designated QM Process Improvement (PI) position in Trauma Centers with a trauma registry volume greater than 1500 patients per year which is separate from the TPM position. This position should initiate the concurrent review process and, in conjunction with the TPM, facilitate the PI process to loop closure. This position should report directly to the TPM. E E E D NA C. The TMD shall have a leadership role in trauma center QM. E E E E E D. The following shall be included in the QM of the trauma program: (1) Structure to ensure that defined program outcomes and performance measures are developed and monitored regularly; to include: E E E E E (a) Trauma Patient Identification; E E E E E (b) Peer Review; and E E E E E (c) Audit filters; E E E E E (2) A hospital trauma registry with participation in the State trauma registry; E E E E E (3) Special audit of all trauma deaths; E E E E E (4) Morbidity and Mortality reviews; E E E E E (5) Evaluation of nursing care, medical care, utilization review, tissue review, and pre hospital care; E E E E E (6) Trauma center by-pass status including, if applicable, both medevac fly-by and ground unit re-route statistics; and E E E E E (7) Documentation of quality management available to demonstrate the multidisciplinary approach to the quality management program including and if appropriate: E E E E E (a) Problem Identification; (b) Analysis; (c) Action plan; (d) Implementation; (e) Reevaluation; and (f) Loop Closure/Resolution. E. The liaisons on the multidisciplinary trauma peer review committee shall attend a minimum of 50 percent of those committee meetings. E E E E E F. The TMD shall be involved in the development of the trauma center’s bypass (diversion) protocol. E E E E E G. The trauma surgeon shall be involved in the decision regarding bypass (diversion) each time the center goes on bypass. E E E E E H. The Trauma Center shall minimize trauma bypass hours with a goal of less than 5 percent per month of the total monthly hours. E E E E E I. Trauma center diversion-bypass hours shall be routinely monitored, documented, and reported, including the reason for initiating the diversion policy. E E E E E J. Monthly Review. (1) At one or more appropriate forums in the hospital, the trauma program shall be reviewed monthly, including both clinical care and administration. E E E E E (2) When a resource is required to be within a specified period of time, the time the resource is requested and the time the resource is available shall be documented as part of the QM process and the response times shall be reviewed monthly. E E E E E (3) The following aspects shall be addressed: E E E E E (a) Trends; (b) All deaths; (c) All transfers; (d) Morbidities; (e) Problem identification and solution; (f) Issues identified from the quality management process; and (g) Other trauma system issues. (4) Minutes shall be maintained for all meetings and shall reflect the review of operational events and, when appropriate, the analysis and proposed corrective actions. E E E E E PARC I II III ED A. The trauma center shall: (1) Collaborate closely with MIEMSS in developing, monitoring, and evaluating the effectiveness of prevention and public education programs; E E E E NA (2) Conduct epidemiology research concerning injury control; E E NA NA NA (3) Collaborate with other hospitals or agencies in research; and E E E E D (4) Monitor progress of prevention programs in cooperation with State quality monitoring activities. E E E E NA B. The Trauma centers hall have: (1) An organized and effective approach to injury prevention that prioritizes those efforts based on local trauma registry and epidemiologic data; E E E E NA (2) A dedicated injury prevention coordinator in the trauma center, separate from the TPM position who, in conjunction with the TPM, facilitates outreach and injury prevention strategies specific to the population of the Trauma Center; E NA NA NA NA (3) A designated injury prevention individual in the trauma center, separate from the TPM position, who, in conjunction with the TPM, facilitates outreach and injury prevention strategies specific to the population of the Trauma Center; NA E E D NA (4) Outreach activities and program development that address one of the major causes of injury in the community; E E E E E (5) Information resources; and E E E E E (6) Collaboration with existing national, regional, state and local programs. E E E E E PARC I II III ED A. A trauma center shall have: E E NA NA NA (1) An organized trauma research program with a designated physician director and documented research plan; (2) Regular meetings of the research group; and (3) Evidence of productivity through peer review. B. The Trauma Center shall have: (1) Proposals reviewed by an institutional review board; E E D D NA (2) Presentations at local, regional, or national meetings; E E D D NA (3) Publications in peer-reviewed journals on an average of seven per year; and E E D D NA (4) Clinical research trials designed to enhance the trauma system’s ability to resuscitate, stabilize, and treat trauma patients in the most cost-effective manner. E E D D NA PARC I II III ED A. A trauma center shall: (1) Assist MIEMSS with developing, monitoring, and evaluating the effectiveness of out-of-hospital training programs; and E E E E NA (2) Engage in public and professional education. E E E E NA B. The hospital shall offer: (1) Trauma education for: E E E E D (a) Hospital Nurses and physicians; (b) Community Nurses and Physicians; (c) Pre-hospital personnel; and (d) Allied health personnel; (2) A trauma critical care fellowship training program; E NA NA NA NA (3) A surgical residency program accredited by the Accreditation Council for Graduate Medical Education; and E E NA NA NA (4) Participation in undergraduate medical education. E E NA NA NA PARC I II III ED A hospital shall have: A. Formal internal continuing education programs concerning the treatment and care of the trauma patients for: E E E E D (1) Physicians; (2) Nurses; and (3) Allied health personnel; B. Special training for personnel exclusively on trauma protocols and trauma care for all new physicians, nurses, and allied health personnel assigned to units where trauma care is provided; and E E E E E C. A continuing education program concerning the care and treatment of trauma patients for physicians, nurses, and allied health personnel in the region. E E E E NA PARC I II III ED The following patient treatment and care documents shall be written, distributed, and monitored for quality: E E E E E A. Resuscitation policy; B. Transfusion and Massive Transfusion policy; C. Infection control plan(can utilize hospital plan); D. Trauma team activation policy; E. Physician call schedule; F. Subspecialty notification policy; G. Inter-hospital transfer policy; H. A policy providing that trauma patients may not be admitted or transferred by a primary care physician without the knowledge and consent of the trauma service, with monitoring of adherence by the QM program; I. Helicopter safety policy; and J. Organ procurement policy. E E E E E PARC I II III ED A. There shall be a Trauma Program Manager (TPM) who is a registered nurse and who 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 Trauma Medical Director (TMD). E E E E NA B. There shall be a defined organizational structure which delineates the roles and responsibilities of the TPM. E E E E NA C. This must be a full-time (1.0 FTE) position dedicated to the management of the trauma program. NA E E E NA D. The institution’s organization shall define the structural role of the TPM to include responsibility, accountability, and authority. NA E E E NA E. The TPM shall: (1) Possess evidence of appropriate qualifications including academic and trauma-related education and clinical experience; E E E E NA (2) Have a job description developed by the hospital to reflect the role and responsibilities as defined by COMAR, and be shown on an organizational chart depicting the relationship between the TPM and other services, including the Department of Nursing; E E E E NA (3) Attend and participate in local, state and national trauma-related activities, including but are not limited to: EMS Advisory Councils, State trauma-related committees and events, National trauma-related activities and events; E E E E NA (4) Participate in trauma educational activities external to the institution’s staff development programs; E E E E NA (5) As requested, participate in multidisciplinary trauma research; E E D D NA (6) Have sufficient administrative and budgetary commitment in order to support the needs of the Trauma Program inclusive of clerical and clinical nursing personnel that help fulfills needs of the concurrent performance Improvement, outreach and injury prevention; E E E E NA (7) Supervise the Trauma Registry staff and trauma clinical QM staff and have oversite for injury prevention and outreach; NA E E E NA (8) Identify an alternate supervisor to supervise the trauma registry if needed; and E NA NA NA NA (9) The TPM and/or TMD will have the oversight and approval of internal trauma-related education programs within each trauma center. E E E E NA PARC I II III ED A. The Trauma Center shall maintain a Trauma Registry. E E E E NA B. The Trauma Registry shall include at a minimum, all of the data elements compliant with the Maryland Trauma Registry Data Dictionary for Adult Patients, including: E E E E NA (1) Demographic Data; E E E E NA (2) Pre-hospital Data; E E E E NA (3) Process of acute Care; E E E E NA (4) Clinical Data; E E E E NA (5) Outcome Data; E E E E NA (6) Final Anatomical Diagnosis; E E E E NA (7) Procedure Codes; E E E E NA (8) Quality Management Data; E E E E NA (9) Standard Report Utilization; and E E E E NA (10) Case Inclusion Criteria. E E E E NA C. 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 the injured patient across the continuum from injury prevention to outcomes measurement. E E E E NA D. The Trauma Registry may be under a separate department that provides support and conducts the registry data abstraction and ensures that: E NA NA NA NA (1) There is a reporting structure from the Trauma Registry to the TPM; and NA E E E NA (2) The trauma registry content staff will be under the direct supervision of the TPM/TMD. NA E E E NA E. 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 E E E NA F. 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 E E E E NA (2) Either: (a) 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; or E E E E NA (b) An electronic interfaced data-content mechanism. E D D D NA G. 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. E E E E NA H. All records shall be completed within 60 days of patient discharge; validation and NTDB checks shall be completed and the records shall be closed. An exception to the completeness of the MTR record is with Medical Examiner (ME) where autopsies are unavailable for registry record abstraction. E E E E NA I. The Trauma Registry shall have a plan to ensure Inter-rater reliability of the data entered into the MTR at the individual trauma centers. Ongoing review and evaluation shall ensure the quality, reliability and validity of the institution’s MTR registry data. E E E E NA J. The Trauma Center shall submit data to the National Trauma Data Bank. E E E E NA K. Trauma Registry Staff shall have: (1) A job description developed by the hospital to reflect the role and responsibilities as defined by COMAR; E E E E NA (2) A core set of skill requirements including: E E E E NA (a) Anatomy and Physiology; E E E E NA (b) Medical Terminology; and E E E E NA (c) Education to be completed within 1 year of hire includes: E E E E NA (i) American Trauma Society Trauma Registrar Course; and E E E E NA (ii) Association of the Advancement of Automotive Medicine’s Injury Scaling Course; and E E E E NA (3) Job responsibilities to include: (a) Ensuring assigned cases are compliant with MD Data Dictionary Inclusion Criteria or other Trauma Center self-defined criteria; E E E E NA (b) Compiling abstracted data for MTR case from various sources; and E E E E NA (c) Appropriately coding injuries, complications and procedures. E E E E NA L. The Trauma Registry staff liaison shall: (1) Attend a minimum of 50 percent all trauma multidisciplinary/peer review meetings that are held; and E E E E NA (2) Actively participate in the MD Trauma Quality Improvement Committee (TQIC) via attendance in person or phone as defined by the individual institution. E E E E NA PARC I II III ED A. The Trauma Center shall have a hospital Emergency Preparedness/Disaster plan described in the hospital’s policy and procedure manual or equivalent. E E E E E B. The hospital disaster plan shall have a hazards vulnerability analysis to guide the response plan. E E E E E C. The Hospital Incident Command System (HICS) shall be used as a management system for incident command, planning logistics, operations and finance/administrative functions. E E E E E D. A tiered – approach depending on the magnitude of the event and alternatives for care shall be identified. E E E E E E. The Trauma Center shall be represented on the hospital’s Emergency Preparedness/Disaster Committee. E E E E NA F. The Trauma Center hospital shall: E E E E E (1) Participate in local, state and/or national disaster management meetings, plans and exercises; and (2) Conduct hospital drills that test the individual hospital’s disaster plan at least twice a year, including actual plan activations that can substitute for drills. E E E E E G. A written plan for supporting Trauma Center incident debriefing shall be accessible for all staff members. E E E E E MIEMSS shall use the following criteria when designating or reverifying trauma centers from among those applicant hospitals that apply for designation or reverification: Standards in this chapter; Patient volume; Geographic coverage; Population; Competing applications; and New applications. When applying the criteria, MIEMSS may consider: Applicable guidelines and professional standards; Trauma outcome standards; and Published results of peer-reviewed trauma research. An applicant hospital shall comply with the applicable standards for trauma care in Regulations .01—.19 of this chapter. Patient Volume. When considering an applicant hospital for designation or reverification, MIEMSS shall take into account the number and distribution of trauma centers that allow designated trauma centers to: Minimize duplication of services; Achieve and sustain the volumes necessary for: Optimal outcome; Cost efficiency; Maintenance of expertise; Quality care; and Where applicable, research and physician and nurse education; and Minimize the potential adverse effect on quality of care that may result if volumes are reduced. Unless the volume criteria are waived under the geographic coverage criteria in §E of this regulation, the minimum acceptable annual volume of admissions for an applicant hospital requesting designation or reverification at the following levels is: For PARC: 2,000 total trauma hospital admissions; and 800 hospital admissions of patients with severe injury; For Level I: 800 total trauma hospital admissions; and 240 hospital admissions of patients with severe injury; For Level II: 400 total trauma hospital admissions; and 120 hospital admissions of patients with severe injury; and For Level III: 300 total trauma hospital admissions; and 75 hospital admissions of patients with severe injury. In the volume criteria: Total trauma hospital admissions include all trauma patients who meet the case inclusion criteria, as defined in the Maryland State Trauma Registry Data Dictionaries issued by MIEMSS, and who are treated at the hospital: As an inpatient admission; or For trauma resuscitation, as an outpatient; and Hospital admissions of patients with severe injury include only injured patients who: Are admitted as inpatients; and Meet the injury severity criteria in Regulation .21 of this chapter. Geographic Coverage. When considering an applicant hospital for designation or reverification, MIEMSS shall: Ensure reasonable geographic access to the trauma system; Minimize duplicative services within close proximity; and Consider the number, geographic distribution, and resource capabilities of other hospitals and trauma centers within the Statewide trauma system. An applicant hospital that is located within 30 linear miles of a same or higher level trauma center shall meet the volume requirements contained in §D of this regulation. MIEMSS may waive the volume requirements contained in §D of this regulation for an applicant hospital that is located at a distance greater than 30 linear miles from an existing trauma center. Population. When considering an applicant hospital for designation or reverification, MIEMSS: Shall take into account the applicant hospital's geographic trauma patient catchment area given the current and projected population density within that area; Shall require a population base of approximately 1 million for designation or reverification as a PARC or Level I or Level II trauma center; Shall utilize the most recent population data published by the State Data Center of the Maryland Office of Planning; and May waive the population requirement contained in this section for an applicant hospital that meets the volume requirements contained in §D of this regulation. Competing Applications. MIEMSS may give preference to an applicant hospital with a designated specialty referral center which may support or be supported by the presence of a trauma center. If there are two or more applicants for the same level in the same geographic coverage area where patient volumes or population would likely be insufficient to support both applicants, based on the criteria in §§C—F of this regulation and Regulation .21 of this chapter, MIEMSS shall: Give preference to the applicant with an established trauma program that can demonstrate that its past experience and performance: Is indicative of quality patient care; Is consistent with professional standards; and Results in optimal patient outcome; and Consider demonstrated patient outcomes and the recommendation of the site survey team to determine the most qualified applicant if both applicants have been verified through MIEMSS' inspection as meeting the standards for the requested level. If two or more applicants for different levels in the same geographic coverage area meet all criteria, and patient volumes would likely be insufficient to support both applicants, MIEMSS may give preference to the applicant seeking the higher level trauma designation or reverification. New Applicants. A hospital applying for designation as a trauma center that has not been previously designated as a trauma center pursuant to this subtitle shall: Meet the trauma designation criteria; and Demonstrate that its proposed trauma center can generate sufficient patient volume without adversely affecting patient volumes at other existing, designated trauma centers. For the purposes of Regulation .20D(2)—(3) of this chapter, a patient with severe injury shall have: An injury severity score (ISS) greater than or equal to 13; A penetrating injury with systolic blood pressure of less than or equal to 90 millimeters of mercury; A thoracic injury classified as one or more of the following International Classification of Diseases 9th Revision Clinical Modification (ICD-9-CM) codes: 861.21 — Lung contusion, without open wound to thorax; 861.31 — Lung contusion, with open wound into thorax; or 807.4 — Flail chest; A blunt injury to the abdomen with major solid visceral injury classified as one or more of the following ICD-9-CM codes: 864.03 — Moderate laceration injury to liver without mention of open wound into cavity; 864.04 — Major laceration injury to liver without mention of open wound into cavity; 864.13 — Moderate laceration injury to liver with open wound into cavity; 864.14 — Major laceration of liver with open wound into cavity; 865.03 — Injury to spleen with laceration extending into parenchyma without mention of open wound into cavity; 865.04 — Injury to spleen with massive parenchymal disruption without mention of open wound into cavity; 865.13 — Injury to spleen with laceration extending into parenchyma and open wound into cavity; 865.14 — Injury to spleen with massive parenchymal disruption and open wound into cavity; 866.01 — Hematoma of kidney without rupture of capsule or mention of open wound into cavity; 866.02 — Laceration of kidney without mention of open wound into cavity; 866.11 — Hematoma of kidney without rupture of capsule but with open wound into cavity; or 866.12 — Laceration of kidney with open wound into cavity; A major surgical procedure in the cranial, thoracic, vascular, abdominal, or spinal body regions, classified as one or more of the following ICD-9-CM procedure codes: Cranial: 01.2X — Craniotomy and craniectomy; 01.3X — Incision of brain and cerebral meninges; 01.52 — Hemispherectomy; 01.53 — Lobectomy of brain; 02.0X — Cranioplasty; 02.1X — Repair of cerebral meninges; 02.3 — Extracranial ventricular shunt; 02.92 — Repair of brain; or 02.94 — Insertion of replacement of skull tongs or halo traction device; Thoracic: 34.02 — Exploratory thoracotomy; 34.82 — Suture of laceration of diaphragm; 34.84 — Other repair of diaphragm; 37.1X — Cardiotomy and pericardiotomy; or 37.91 — Open chest cardiac massage; Vascular: 38.3 — Resection of vessel with anastomosis (use 4th digits 2, 3, 4, 5, 6, 7, 8, 9); 38.4 — Resection of vessel with replacement (use 4th digits 2, 3, 4, 5, 6, 7, 8, 9); 38.8 — Other surgical occlusion of vessels (use 4th digits 2, 3, 4, 5, 6, 7, 8, 9); 39.3 — Suture of vessel; 39.56 <MD >Repair of blood vessel with tissue patch graft; 39.57 — Repair of blood vessel with synthetic patch graft; 39.58 — Other repair of vessel; 39.6X — Extracorporeal circulation and procedures auxiliary to heart surgery; or 39.98 — Control of hemorrhage, not otherwise specified; Abdominal: 41.43 — Partial splenectomy; 41.5 — Total splenectomy; 41.95 — Repair and plastic operations on spleen; 42.82 — Suture of laceration of esophagus; 42.89 — Other repair of esophagus; 44.61 — Suture of laceration of stomach; 44.69 — Other repair of stomach, not otherwise specified; 45.0X — Enterotomy; 45.5X — Isolation of intestinal segment; 45.6X — Other excision of small intestine; 45.7X — Partial excision of large intestine; 45.8 — Total intra-abdominal colectomy; 46.0 through 46.03 — Other operations on intestine; 46.7X — Other repair of intestine; 50.0 — Hepatotomy; 50.22 — Partial hepatectomy; 50.3 — Lobectomy of liver; 50.4 — Total hepatectomy; 50.6X — Repair of liver; 52.5X — Partial pancreatectomy; 52.6 — Total pancreatectomy; 52.95 — Other repair of the pancreas; 54.11 — Exploratory laparotomy; 55.4 — Partial nephrectomy; 55.5X — Complete nephrectomy; 55.8X — Other repair of kidney; 56.8X — Repair of ureter; or 57.8X — Other repair of urinary bladder; or Spinal: 03.53 — Repair of vertebral fracture; 81.00 — Spinal fusion, not otherwise specified; 81.01 — Atlas-axis spinal fusion; 81.02 — Other cervical fusion, anterior technique; 81.03 — Other cervical fusion, posterior technique; 81.04 — Dorsal and dorsolumbar fusion anterior technique; 81.05 — Dorsal and dorsolumbar fusion, posterior technique; or 81.06 — Lumbar and lumbosacral fusion, anterior technique; A major pelvic fracture, classified as one or more of the following ICD-9-CM codes: 808.43 — Multiple, closed, pelvic fractures with disruption of pelvic circle; or 808.53 — Multiple, open, pelvic fractures with disruption of pelvic circle; or Two or more long bone lower extremity fractures that can be either ipsilateral or contralateral, classified as one or more of the following ICD-9-CM codes: 820.XX — Fractures of neck of femur; 821.XX — Fractures of other and unspecified parts of femur; or 823.X2 — Fractures of fibula with tibia. Education Article, §13-509, Annotated Code of Maryland Effective date: March 24, 1997 (24:6 Md. R. 488) Regulation .03F amended effective June 4, 2007 (34:11 Md. R. 972) Regulation .13A amended effective July 1, 2002 (29:12 Md. R. 933) Regulation .13F amended as an emergency provision effective June 1, 2006 (33:15 Md. R. 1277); amended permanently effective October 23, 2006 (33:21 Md. R. 1679) Regulation .15A amended effective July 1, 2002 (29:12 Md. R. 933) Regulation .15B amended effective June 4, 2007 (34:11 Md. R. 972) Regulation .17A amended effective July 1, 2002 (29:12 Md. R. 933) Regulations .20 and .21 adopted as an emergency provision effective November 7, 1997 (24:25 Md. R. 1718); adopted permanently effective March 9, 1998 (25:5 Md. R. 371) Regulation .20 amended effective July 1, 2002 (29:12 Md. R. 933) Regulation .20D amended effective June 4, 2007 (34:11 Md. R. 972) Chapter revised effective July 1, 2018 (45:9 Md. R. 463) Regulation .03C amended effective July 21, 2025 (52:14 Md. R. 714) Regulation .13A, B amended effective April 17, 2023 (50:7 Md. R. 302) 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) Unless otherwise indicated in this subtitle, MIEMSS shall use the following criteria when designating or reverifying specialty referral centers from among those applicant hospitals that apply for designation or reverification and when contracting with out-of-State specialty referral center hospitals: Applicable standards in this subtitle; Patient volume; Geographic coverage; Population; Demonstrated expertise of the professional staff in the specific specialty care area; Active research program focused on specific specialty care area; Competing applications; and New applications. The criteria listed in Regulation .01 of this chapter do not apply to burn, perinatal, neonatal, or designated primary stroke specialty referral centers. When applying the criteria, MIEMSS may consider: Applicable guidelines and professional standards; Patient outcome standards; and Published results of peer-reviewed research. An applicant hospital shall comply with the applicable standards for specialty referral centers in this subtitle. When considering an applicant hospital, MIEMSS shall take into account the number and distribution of specialty referral centers that will allow designated or contract specialty referral centers to: Minimize duplication of services; Achieve and sustain the volumes necessary for: Optimal outcome, Cost efficiency, Maintenance of expertise, Quality care, Research, and Physician and nurse education; and Minimize the potential adverse effect on quality of care that may result if patient volumes are reduced, Volume criteria will be evaluated for each specialty referral center based on the: Projected number of patients who would require access to that specialty referral center; and Number of physicians who would provide medical care for that population. When considering an applicant hospital, MIEMSS shall: Minimize duplicative services within close proximity; and Consider the number, geographic distribution, and resource capabilities of other specialty referral centers. When considering an applicant hospital, MIEMSS shall take into account the applicant hospital's geographic specialty patient catchment area given the current and projected population density within an area. When considering an applicant hospital, MIEMSS shall take into account the education and specialty training of the following hospital staff: Physicians; Nurses; and Technicians and support staff. When considering an applicant hospital, MIEMSS may give preference to the applicant with an established and ongoing clinical research program focusing on the specific specialty care area. MIEMSS may give preference to an applicant hospital with a designated trauma center which supports or is supported by the presence of a specialty referral center. If there are two or more applicants for the same type of specialty referral center in the same geographic coverage area where patient volumes or population would likely be insufficient to support both applicants, based on the criteria in Regulations .04—.09 of this chapter, MIEMSS shall: Give preference to the applicant with an established specialty referral program that can demonstrate that its past experience and performance: Are indicative of quality patient care, Are consistent with professional standards, and Result in optimal patient outcome; and Consider demonstrated patient outcomes and the recommendations of the site survey team to determine the most qualified applicant if both applicants have been verified through MIEMSS' inspection as meeting the standards for the requested specialty referral center. An applicant hospital that, under this subtitle, has not previously been designated as a specialty referral center by MIEMSS or contracted with MIEMSS as a specialty referral center shall: Be subject to the specialty referral center designation criteria; and Demonstrate that its proposed specialty referral center can generate sufficient patient volume without adversely affecting patient volumes at other existing, designated, or contract specialty referral centers. Education Article, §13-509, Annotated Code of Maryland Effective date: August 9, 1999 (26:16 Md. R. 1247) Regulation .01 amended effective July 1, 2002 (29:12 Md. R. 933) Regulation .02 amended effective June 5, 2006 (33:11 Md. R. 952) Regulation .03 amended effective July 1, 2002 (29:12 Md. R. 933) Regulations .05 —.11 amended effective July 1, 2002 (29:12 Md. R. 933) In this chapter, the following term has the meaning indicated. 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: In-State hospital designated by MIEMSS and approved by the EMS Board to provide comprehensive pediatric trauma care services; or 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. The hospital's board of directors, administrators, and medical and nursing staffs shall demonstrate commitment to the optimal care of injured pediatric patients by: Formulating a board of director's resolution stating that: The hospital agrees to meet the Maryland Pediatric Trauma Center designation standards; and 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; Establishing an identifiable organization whose dedication to the care of injured children is shown in: Its mission statement; The configuration of its medical, administrative, and support staffs; and The configuration of its physical plant; Participating in the Statewide trauma system, including submission of patient care data to the State Trauma Registry for system and quality management (QM); Assuring that all pediatric trauma patients shall receive medical care commensurate with the hospital's designation as a pediatric trauma center; and 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. The hospital shall: 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; 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; Maintain current equipment and technology to support optimal pediatric trauma care; Admit annually 200 or more injured children who are younger than 15 years old; Have the ability to treat effectively all types of pediatric injuries, including: Brain injury; Spinal cord injury; Solid organ injury; Chest injury; Complex musculoskeletal injury; Burns; Eye injury; Hand and upper extremity injury; and Lower extremity injury; and Have a heliport or helipad positioned at the closest safe location so there is a limited distance from the helipad to the hospital. The pediatric trauma center shall have a pediatric trauma leadership team responsible for monitoring and coordinating all components of the pediatric trauma program, including: A pediatric trauma medical director (TMD) who: Is a board-certified pediatric surgeon; Demonstrates expertise and commitment to the care of injured children; With the trauma program manager (TPM), is empowered by the hospital’s governing body to lead the pediatric trauma center; 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; Has the responsibility for the oversight of the QM process related to all pediatric trauma patients; Participates in and publishes pediatric trauma research; Has a job description developed by the hospital to reflect the role and responsibilities as defined by COMAR; Appears on the hospital’s organizational chart where the relationship between the TMD and other hospital services are depicted and delineated; Participates in local, regional, state and national activities related to pediatric injury care and prevention; and Participates in pediatric trauma education activities such as undergraduate medical education, postgraduate training programs, and continuing education (CE); and A pediatric trauma program manager (TPM) who: Is a 1.0 full-time equivalent (FTE) committed to the management of the pediatric trauma center; Meets the requirements of Regulation .20 of this chapter; and 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. There shall be one or more committees that provide expert input to the hospital’s management of the pediatric trauma program. The committees shall: 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; 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 Monitor, track, and trend pediatric trauma care within hospital departments, medical and nursing staffs, and representative disciplines across the trauma care continuum. The pediatric trauma center shall have a pediatric trauma resuscitation team: Whose members are: Present in house and immediately available upon notification; Oriented to the internal pediatric trauma clinical management protocols and policies; and Have demonstrated skills for pediatric trauma care that are appropriate and specific to their specialty roles; That is available in the trauma resuscitation areas upon arrival of all trauma patients when there is advanced notification; That follows clearly defined policies and protocols for activation criteria and roles and responsibilities; That includes a team leader, who shall be either: An attending pediatric surgeon; or A postgraduate, year-3 or above general surgeon; and 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. 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: Social work; Child psychiatry; Child life therapy; Rehabilitation services, that is, physical, occupational, and speech therapies; and Respiratory therapy. 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. The hospital shall have written policies and procedures to direct the organized and safe interhospital transfer process of pediatric trauma patients. The hospital shall: 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 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. 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. The hospital shall have a process for delineation and reevaluation of privileges that includes: A pediatric trauma panel, which shall be limited to those with demonstrated skills, commitment, experience, and interest in pediatric trauma care; Appointment and reappointment to the pediatric trauma admitting or consulting staff that is coordinated by the medical staff office; and The delineation of privileges for the pediatric trauma admitting or consulting staff approved by the pediatric TMD based on the following criteria: Maintenance of good standing in the primary specialty; Evidence of the required continuing medical education in trauma; 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 Satisfactory performance in managing pediatric trauma patients based on performance assessment and outcome analysis. The hospital shall have continuing medical education (CME) requirements as follows: Pediatric surgeons taking trauma calls shall have evidence of 16 hours of trauma-related CME credits per year; ATLS® may be counted toward the required CME credits; Successful completion of an ATLS® course, at least once, is required for all attending pediatric surgeons providing pediatric trauma care; The TMD and APPs providing pediatric trauma care must maintain a current ATLS® certification; and Physician CME credits shall be documented in accordance with hospital policy. Clinical service requirements are as follows: Pediatric surgery: Board-certified or board-eligible pediatric surgeons trained in trauma care; Either: 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 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 General surgery APPs taking trauma call who have documentation of an average of 16 hours per year of trauma-related education. Pediatric neurosurgery: Either: 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 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; Neurosurgery APPs taking trauma call shall have documentation of average of 16 hours a year of trauma-related education; and A liaison to the trauma QM program with 50 percent attendance. Pediatric Orthopedic surgery: Either: 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 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; Orthopedic surgery APPs taking trauma call shall have documentation of average of 16 hours a year of trauma-related education; and A liaison to the trauma QM program with 50 percent attendance. Pediatric anesthesia: A board-certified or board-eligible in-house attending physician 24 hours a day; and A liaison to the trauma QM program with 50 percent attendance. Pediatric emergency medicine: A physician director who is board certified in pediatric emergency medicine; Board-certified or board-eligible pediatricians, emergency medicine physicians, or pediatric emergency medicine physicians in house 24 hours a day; Physicians who have demonstrated special capabilities through commitment, CME, and experience in the care of injured children; and A liaison to the trauma QM program with 50 percent attendance. Pediatric critical care: A board-eligible or board-certified pediatric critical care physician in house 24 hours a day for the ICU; A designated liaison from pediatric surgery; and A liaison to the trauma QM program with 50 percent attendance. 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: Plastic surgery; Urology; Oral-maxillofacial surgery; Ophthalmology; Otolaryngology, head, and neck surgery; Cardiovascular surgery; and Hand surgery. 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: Radiology; Neuroradiology; Interventional radiology; Physiatry; Psychiatry; Infectious disease; General pediatrics; Neurology; Gastroenterology; Nephrology; Cardiology; Hematology-oncology; Pulmonology; Endocrinology; Pathology; Allergy and immunology; and Angiography. The oversight and responsibility for pediatric trauma nursing care shall be assigned within the Department of Nursing. 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. The nursing department shall participate in the interdisciplinary QM monitoring of pediatric trauma care. 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. The education program developed and approved by the trauma quality improvement committee (TQIC) shall include: An introductory 16-hour trauma nursing curriculum that: Addresses resuscitation and definitive care for pediatric trauma patients; and Covers the continuum of care; and A CE requirement of: 8 hours every year for emergency and critical care nurses; and 4 hours every year for nurses providing pediatric trauma care in other clinical areas. Nursing shall have representation at pediatric trauma multidisciplinary meetings. The hospital shall have an ED dedicated to pediatric care, including: A designated and dedicated ED physician director and nurse manager; A sufficient number of registered nurses and other clinicians who: Have the necessary knowledge and skills to provide care during trauma resuscitation; Are present to manage projected caseloads; and Immediately reinforce the number of staff upon notice of multiple admissions; Defined and agreed upon roles and responsibilities approved by the TMD to ensure availability of ED resources; Verification of functioning life-safety emergency equipment and supplies organized for trauma resuscitation present and immediately available 24 hours a day; An identified pediatric trauma resuscitation room with dedicated staff, equipment, and supplies 24 hours a day; Designation by MIEMSS as a pediatric base station; Policies and protocols for trauma team response and roles in ED trauma resuscitation in accordance with Regulation .20 of this chapter; and Equipment for resuscitation of patients of all ages, including: Airway management equipment and supplies including a “difficult airway cart”; Emergency equipment located in the resuscitation area/ED for: Thoracotomy; Vascular access; Thoracostomy or chest decompression; Bedside ultrasound; Extremity hemorrhage control devices/tourniquet; and Rapid infuser and warmer; Medications necessary for the resuscitation and emergency care of children with immediate capability for appropriate pediatric dosages based on weight in kilograms; Printed pre-calculated pediatric drug dosage reference materials, including, but not limited to, charts, wall posters, and length-based dosage tapes; The following monitoring devices: 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; Pulse oximeter with adult and pediatric probes; Blood pressure cuffs in infant, child, adult, and thigh sizes; Thermometer probe capable of reading from 28 to 42 degrees centigrade; Otoscope; Ophthalmoscope; Transport monitor with pediatric capabilities; Doppler and noninvasive blood pressure monitoring devices for infant, child, and adult; End-tidal carbon dioxide monitor; and Pressure monitor for central venous pressure and arterial line pressure; Standard intravenous fluids and administration devices, including large-bore intravenous catheters; Newborn resuscitation supplies; Compartmental pressure measuring devices immediately available; and Cervical and skeletal traction devices immediately available. The hospital shall have an OR adequately staffed and immediately available and equipped to care for injured children of all ages. The OR shall have supplies, equipment, medications, and staff approved by the TMD to ensure availability of optimal resources. The OR shall have equipment and supplies for microvascular and microneural surgery The hospital shall have a PACU adequately staffed, immediately available, and equipped to care for injured children. The PACU shall: 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; Have equipment for continuous monitoring of temperature, hemodynamics, and gas exchange; and Have available pediatric resuscitation equipment and medications The hospital shall have a separate PICU with the capability to care for all significantly injured children. The PICU shall: Have appropriately trained registered nurse staff to care for the critically injured child to include: Brain injury; Spinal cord injury; Solid organ injury; Chest injury; Complex musculoskeletal injury; Burns; Eye injury; Hand and upper extremity injury; and Lower extremity injury; Be staffed at a level to ensure appropriate nurse-patient ratios as determined by written nursing standards; Have a written plan to: Triage children from the PICU to accommodate acute admissions; or Provide alternative critical care beds with appropriately trained pediatric critical care registered nurses; Have available the pediatric resuscitation equipment and medications; Have the equipment and capability for continuous invasive monitoring of the critically injured child; Have extracorporeal membrane oxygenation capability; Have capability for all renal replacement therapies; and Have support services with immediate access to clinical diagnostic services and stat lab. 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. The general pediatric unit shall: Have the equipment and capability to care for the child with multiple traumatic injuries; Have appropriately trained registered nursing staff to care for the multiply injured child; Be staffed at a level to ensure appropriate nurse-patient ratios as determined by written nursing standards; Have written plans for discharge and transfer of injured children to: Appropriate inpatient rehabilitation; Pediatric home care; and Outpatient follow-up; and Have the support services available for psychological support, rehabilitative therapy, and educational liaison with schools. The hospital shall have: Radiological specialty capabilities and equipment to handle all injured children; Qualified pediatric radiologists and staff available within 60 minutes of consultation notification to perform complex imaging studies or interventional procedures 24 hours a day; 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; Changes in interpretation between preliminary and final reports, as well as missed injuries, monitored through the QM program; In-house radiology technicians 24 hours a day; Computed tomography (CT) scan with an in-house CT technician 24 hours a day; Back-up CT scan capabilities; Angiography; Sonography; Magnetic resonance imaging; Nuclear scanning; and Trans-esophageal echocardiography The hospital shall have: Rehabilitation capabilities adequately staffed with equipment available to treat all injured children while in the pediatric trauma center; Rehabilitation consultation services, occupational therapy, speech therapy, and physical therapy, available in the critical care phase as needed; Pediatric rehabilitation services staffed by personnel trained in pediatric rehabilitation care and properly equipped for acute care of injured pediatric patients; Full in-house service or transfer process in place to a rehabilitation service for long-term care or sub-acute care; and 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. The hospital shall have follow-up services adequately staffed and equipped to treat injured children. Pediatric trauma clinic outpatient follow-up shall be available with coordination of the interdisciplinary team. Pediatric surgical and medical subspecialty clinics shall be available for follow-up care. The hospital shall have clinical laboratory service available 24 hours a day, adequately staffed and immediately available and equipped for injured children. The clinical laboratory service shall have the following services available: Stat lab capabilities; Standard analysis of blood, urine, and other body fluids; Blood-typing and cross match; 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; Blood gas analysis; Coagulation studies; Microbiology; and Toxicological screening. 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. The following shall be included in the pediatric QM program: A structure to ensure that defined program outcomes and performance measures are developed and monitored regularly; A special audit of all pediatric trauma deaths; Review of morbidity and mortality; Evaluation of medical care, nursing care, utilization review, tissue review, and prehospital care; Monthly review, at an appropriate interdisciplinary forum, of the performance of the pediatric trauma program, including: Trends; All deaths; All transfers; Morbidities; Problem identification and solution; Issues identified from the QM process; and System or administrative issues; Maintenance of minutes for all meetings in accordance with the hospital QM program; Requirements for designated liaisons (medical and nursing) to attend at least 50 percent of the trauma peer review meetings, and with supporting documentation; Requirements for all pediatric general surgeons who take pediatric trauma call to attend at least 50 percent of the trauma peer review meetings; Documentation of QM to demonstrate the interdisciplinary approach to the QM program, including: Problem identification; Analysis; Action planning; Implementation; Reevaluation; and Corrective action; and Monitoring of Level I Pediatric Trauma Center bypass status including “fly-by” and re-route events. The level I pediatric trauma 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 including studies in injury control; Collaborate with other hospitals, MIEMSS, or other agencies in pediatric injury prevention initiatives and research; Have an organized and effective approach to injury that prioritizes those efforts based on the Maryland State Trauma Registry (MSTR) and epidemiologic data; Monitor progress of prevention programs in cooperation with State QM activities; Have a designated prevention coordinator; Have outreach and program development activities targeted to pediatric injury prevention within the region and State; Have information resources for children and families; and Collaborate with existing national, regional, and State programs. The level I pediatric trauma center shall: Have an organized pediatric trauma research program with a designated physician director and a documented research plan; Hold regular meetings of the research group; Show evidence of productivity; Have research proposals reviewed by an institutional review board; Conduct clinical research designed to enhance the trauma system’s ability to resuscitate, stabilize, and treat trauma patients in the most cost-effective manner; Present research study results at local, regional, and national meetings; and Produce publications in peer-reviewed journals on an average of seven times per year. The hospital shall: Assist MIEMSS with developing, monitoring, and evaluating the effectiveness of EMS training programs; Offer and participate in formal pediatric trauma CE for hospital personnel and community health care clinicians; Have a pediatric surgery fellowship program accredited by the Accreditation Council of Graduate Medical Education (ACGME); Participate in a general surgical residency program accredited by the ACGME; Participate in a pediatric emergency medicine fellowship program; and Participate in undergraduate medical and nursing education. 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. The hospital shall: Provide formal internal continuing education programs for physicians, nurses, and allied health professionals; 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 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. The hospital shall develop, distribute, and monitor implementation of the following patient treatment and care protocols: Pediatric resuscitation protocol; Procedural sedation protocols for children; Transfusion and massive transfusion protocol; Infection control protocol; Pediatric trauma resuscitation team activation protocol; Physician call schedule and notification protocol; Interhospital transfer protocol; Helicopter safety protocol; Organ procurement protocol; Child protection team protocol; Pediatric psychosocial care protocol; and Pediatric rehabilitation care protocol. The hospital shall have written transfer agreements with specialty and pediatric rehabilitation centers. 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. There shall be a defined organizational structure, which delineates the roles and responsibilities of the TPM. The TPM shall be a 1.0 FTE position dedicated to the management of the pediatric trauma center. The institution’s organization shall define the structural role of the TPM to include responsibility, accountability, and authority. The TPM shall: 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; 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; 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; As requested, participate in multidisciplinary trauma research; 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; Supervise the Trauma Registry staff and trauma clinical QM staff and have oversite for injury prevention and outreach; and With the TMD, have oversight and approval of internal trauma-related education programs. 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: Demographic data; Pre-hospital data; Process of acute care; Clinical data; Outcome data; Final anatomical diagnoses; Procedure codes; QM data; Standard report utilization; and Case inclusion criteria. 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. 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. The Trauma Program Manager shall have the authority, responsibility, accountability, and oversight of the Trauma Registry, inclusive of data submission as required by MIEMSS. The Trauma Registry shall have: A staffing plan that includes workload analysis that defines personnel needs necessary to comply with the MIEMSS data submission requirements, and 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. 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. All records shall be completed within 60 days of patient discharge. 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. 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. The Trauma Center shall submit data to the NTDB. Trauma Registry staff shall have: A job description developed by the hospital to reflect roles and responsibilities; Core requirements including: Anatomy and physiology; Medical terminology; and Education to be completed within 1 year of hire includes: American Trauma Society Trauma Registrar Course; and Association of the Advancement of Automotive Medicine’s Injury Scaling Course; and Job responsibilities to include: Ensuring assigned cases are compliant with Maryland Data Dictionary Inclusion Criteria or other trauma center self-defined criteria; Compiling abstracted data for MSTR case from various sources; and Appropriately coding injuries, complications, and procedures. The Trauma Registry staff liaison shall: Attend a minimum of 50 percent all trauma multidisciplinary/peer review meetings that are held; and Actively participate in the Maryland TQIC. The trauma center shall have a hospital emergency preparedness or disaster plan described in the hospital’s policy and procedure manual or equivalent. The hospital disaster plan shall have a hazards vulnerability analysis to guide the response plan. Hospital Incident Command System shall be used as a management system for incident command, planning, logistics, operations, and finance/administrative functions. A tiered approach depending on the magnitude of the event and alternatives for care shall be identified. The trauma center shall be represented on the hospital’s emergency preparedness or disaster committee. The trauma center hospital shall: Participate in local, state, or national disaster management meetings, plans, and exercises; 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 Have a written plan for supporting trauma center. Education Article, §13-509, Annotated Code of Maryland Effective date: September 7, 1998 (25:18 Md. R. 1439) Regulation .01B amended effective July 1, 2002 (29:12 Md. R. 933) Regulation .03E amended effective June 4, 2007 (34:11 Md. R. 972) Regulation .06C amended effective July 1, 2002 (29:12 Md. R. 933) Regulation .16A amended effective July 1, 2002 (29:12 Md. R. 933) Regulation .16 amended effective June 4, 2007 (34:11 Md. R. 972) Regulation .18A amended effective July 1, 2002 (29:12 Md. R. 933) Regulations .01—.20 repealed and new regulations .01 — .22 adopted effective July 24, 2023 (50:14 Md. R. 594) Regulation .02B amended effective July 21, 2025 (52:14 Md. R. 714) The hospital shall: Be designated by MIEMSS and approved by the EMS Board as a Level II, Level I, or PARC trauma center; Have a board of directors' resolution that states its commitment to provide state-of-the-art optimal eye trauma care as part of the Statewide emergency medical system; Have an organized eye trauma center with a medical director who has: Authority to run the eye trauma center; and Responsibility for: Clinical coordination of the eye trauma center; Quality management; and Participation in the State and regional EMS system quality management, education, and prevention activities; and Have a designated eye trauma center nurse manager who has authority and responsibility for nursing and patient care services. The hospital shall have: The following physician coverage: An ophthalmology fellow or ophthalmology resident in house 24 hours a day, to be at the bedside within 30 minutes for emergent consultation requests, with a board-certified or board-eligible ophthalmologist on call and available to be at the bedside within 60 minutes for emergent consultation requests; and A board-certified or board-eligible emergency medicine physician in house 24 hours a day for eye trauma triage, with a board-certified or board-eligible attending ophthalmologist on call and available be at the bedside within 60 minutes for emergent consultation; and Ophthalmic subspecialty coverage on call and available 24 hours a day for vitreoretinal, oculoplastics, and anterior segment surgery. The hospital shall provide all nurses who care for patients in the eye trauma center with: Special education in ophthalmic emergencies and eye trauma care; and Specific orientation to eye trauma center procedures and protocols for ophthalmic emergencies. A nurse working in the eye trauma center, adult and pediatric ED RN involved with eye trauma triage and care in that setting, and pre/post op and OR eye surgery staff shall have at least 4 hours of continuing education in ophthalmic emergencies every 2 years. Ophthalmic Treatment Area. The hospital shall have: An ophthalmic treatment area that is identified for and dedicated to the examination of ophthalmic emergencies; A medical director of the eye trauma center to oversee the management of the ophthalmic treatment area; A nurse manager responsible for the ophthalmic treatment area; Organized equipment and supplies to care for eye trauma, including: A slitlamp biomicroscope; An indirect ophthalmoscope; A visual acuity chart (that is, Snellen and near chart); Color plates, either Ishihara, or Hardy-Rand-Rittler; Applanation Tonometry (that is, Tonopen, iCare®); and Diagnostic ophthalmic lenses for gonioscopy and ophthalmoscopy; The following readily available medications necessary for the treatment and diagnosis of ophthalmic emergencies (in the event of regional or national drug shortages, pharmacy will assist with sourcing of appropriate, alternative options): Systemic eye pressure lowering medications; Topical intraocular pressure lowering medications of different classes; Mydriatic and cycloplegic drops; Topical anesthetics, such as proparacaine and tetracaine; and Fluorescein drops or strips; Sterile surgical sets specifically for ophthalmic trauma care readily available and located in the ophthalmic treatment area, including: Vitreous tap and inject equipment; Lateral canthotomy set; Ocular lavage set-up; and pH strips; Equipment for skin laceration repair; The following equipment: Laser iridotomy (YAG or Argon); Argon laser for retinopexy; Cryoprobe available for retinopexy; and Either of the following equipment for pneumatic retinopexy: SF6; or C3 F8 gas; and Corneal foreign body removal equipment such as 27-30 gauge needle and corneal burr; Pharmacy support available to obtain intravitreal antimicrobial medications and steroids within 1 hour, 24 hours a day; and Pharmacy support available to obtain topical fortified antimicrobial medications within 1 hour, 24 hours a day. Operating Room (OR). The hospital shall have an OR: With adequately trained staff in ophthalmic surgery available with 1-hour response for ophthalmic emergencies 24 hours a day as needed per eye trauma center policies and procedures; Available ophthalmic surgery within 1 hour of notice; and With operating microscope equipment readily available for: Vitreoretinal surgery; Oculoplastic surgery; Anterior segment surgery; and Pediatric patients. The hospital shall have an inpatient unit available with inpatient beds with nursing staff who have knowledge and skills specific for the care of post-operative patients. Ongoing care management and disposition of care may be integrated into the outpatient setting as indicated. A hospital shall have CT scan and ocular echography available 24 hours a day. The hospital shall: Have ongoing QM of the eye trauma center that is integrated into the hospital's overall QM program; Participate in the State EMS system QM activities, as described in this subtitle; Maintain an eye trauma registry; Participate in and maintain the State eye trauma registry; and Have QM activities, including: Problem identification; Problem analysis; Action planning; Implementation of the plan; Reevaluation of the plan; and Loop closure. The hospital shall: Provide leadership and coordination for the development and implementation of prevention and public education programs for eye injuries; and Monitor the progress of eye trauma prevention programs in cooperation with State quality monitoring activities. The hospital shall: Have an organized eye clinical research program with a documented research plan; and Conduct research and submit to MIEMSS a summary of publications that may span topics of prevention, interventions, outcomes, or costs of treatment. The Eye Trauma Center shall develop and provide education and training concerning ophthalmic injuries for: Physicians; Nurses; EMS clinicians; and Other appropriate allied health personnel. Education Article, §13-509, Annotated Code of Maryland Effective date: May 3, 1999 (26:9 Md. R. 731) Regulation .01A amended effective July 1, 2002 (29:12 Md. R. 933) Regulation .01C, D amended effective March 7, 2022 (49:5 Md. R. 367) Regulation .02 amended effective March 7, 2022 (49:5 Md. R. 367) Regulation .03 amended effective March 7, 2022 (49:5 Md. R. 367) Regulation .04 amended effective March 7, 2022 (49:5 Md. R. 367) Regulation .05 amended effective June 4, 2007 (34:11 Md. R. 972); March 7, 2022 (49:5 Md. R. 367) Regulation .05D amended effective July 1, 2002 (29:12 Md. R. 933) Regulation .07B amended effective July 1, 2002 (29:12 Md. R. 933); March 7, 2022 (49:5 Md. R. 367) Regulation .08 amended effective July 1, 2002 (29:12 Md. R. 933); March 7, 2022 (49:5 Md. R. 367) A neurotrauma center hospital shall: Maintain a specialized unit dedicated to traumatic brain injury and spinal cord injury; Be designated as Level 1 trauma center or PARC by MIEMSS; Demonstrate both a medical and administrative commitment to the care of the neurotrauma patient by: Having a board of director's resolution stating: That the hospital agrees to meet the neurotrauma standards for designation; and The hospital's commitment to the infrastructure and the financial, human, and physical resources necessary to support the neurotrauma center; Establishing an identifiable organization whose dedication to the care of the neurotrauma patient is shown in: Its mission statement; The configuration of its medical, administrative, and support staffs; and The configuration of its physical plant; and Maintain current hospital 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. A neurotrauma center shall: Participate in the Statewide trauma and specialty care system, including submission of patient care data to the State trauma registry for quality management; and Receive a minimum annual volume of 100 traumatic brain injured patients, spinal cord injured patients, or both. Prehospital Care. A neurotrauma center shall: Maintain access to an EMS system for the transport of patients with neurotrauma injuries from referral sources within the geographic service area; Demonstrate participation and involvement in local, regional, or State trauma EMS systems; and Provide education on the current concepts in emergency and inpatient neurotrauma treatment to prehospital and hospital care clinicians within its geographic service area. A neurotrauma center shall have a director who provides oversight to all care for neurotrauma patients admitted to the center. The neurotrauma center director shall meet the requirements in Regulation .05 of this chapter. Responsibilities of the neurotrauma center director include: Creation of policies procedures, and protocols/guidelines for the neurotrauma center that specify the care of neurotrauma patients; Participation with the State EMS system in development of policies and protocols for use throughout the EMS system for initial care, triage, and transport of neuro-injured patients; Communication on a regular basis with physicians and other authorities regarding patients who have been referred; Direction of the neurotrauma center administrative functions in collaboration with Level I/PARC leadership; Direction and active participation in the neurotrauma quality management (QM) program; and Development of and participation in both internal and external continuing medical education (CME) programs in the care and prevention of neuro injuries. A neurotrauma center shall have the following team members: A Board-certified or board-eligible, in-house neurosurgery attending or PGY2 or higher, dedicated 24 hours a day to trauma care, with a neurosurgery attending on call who shall be at the patient bedside within 30 minutes after emergent consultation has been requested by the trauma team leader for injured patients based on institution-specific criteria; A trauma fellowship-trained general surgeon; A board-certified anesthesia attending; A board-certified orthopedic or neurosurgery spine attending surgeon or PGY2 or higher orthopedic or neurosurgery resident with an attending on call with a 30-minute response to the patient bedside; A board-certified or board-eligible trauma/critical care attending or critical care fellow with a trauma/critical care attending on call with a 30-minute response to the patient bedside; and An on-call schedule for residents, fellows, and attendings who are assigned to the neurotrauma center. Appointment and Qualifications of Attending Neurosurgeons. The neurotrauma center director shall appoint qualified attending staff surgeons to participate in the care of patients in the center. An attending neurosurgeon shall meet the requirements in Regulation .05 of this chapter. Category/Description Director Staff Surgeons A. Certification. All neurosurgeons shall be board-certified or board-eligible in neurosurgery. A qualified Neurosurgeon shall be regularly involved in the care of patients with neurologic injuries and shall be credentialed by the hospital with general neurosurgical privileges. Required Required B. Continuing Medical Education. The CME qualification requires annual participation in at least 16 hours or more of trauma or neurotrauma related CME per year. Required Required C. Research Participation. The research participation qualification is to demonstrate a commitment to clinical or basic science neurotrauma care which can be met by: Required Desirable (1) Annual submission of an abstract or publication related to neuro injuries; or (2) Research projects in progress. D. Community Education and Neurotrauma Injury Prevention. The community education and neurotrauma injury prevention qualification is to participate in: Required Desirable (1) The development or revision of community or EMS neurotruama treatment protocols, or representation on a State or local EMS committee; and (2) At least one of the following: (a) Annual participation in one or more prehospital training/certification courses in neurotrauma care which can be met by prehospital basic life support or advanced life support courses or equivalent courses; (b) Annual development or presentation of neurotrauma care courses or lectures which can be met by prehospital basic life support or advance life support courses or equivalent courses; or (c) Participation in a neurotrauma injury prevention program. A neurotrauma center shall have: A nurse manager who is administratively responsible for the center; An organizational chart relating the nurse manager to other members of the neurotrauma center and the hospital; and A masters-prepared advanced practice nurse with clinical expertise in neurotrauma care with responsibility for clinical nursing oversight and nursing staff consultation. The nurse manager shall have: A registered nurse license; A baccalaureate or higher degree in nursing; At least 2 or more years of experience in acute neurotrauma care; and At least 1 year or more of experience in an intensive care unit (ICU). The neurotrauma center nursing department shall: Have a patient classification system/staffing matrix for nurse staffing that meets the care needs for each patient in the neurotrauma center; Have a neurotrauma center orientation program that documents nursing competencies specific to the care and treatment of acute neurologic injuries; Have appropriately trained nursing staff to manage the complex physical and emotional needs of neurotrauma patients; Have a neurotrauma orientation program that each new staff nurse hired shall complete before assuming independent practice in the center; After completion of the introductory education mandated in this regulation, have continuing education (CE) that is current, meeting the following requirements: 8 hours of neuro/trauma-related CE every year for emergency and neurotrauma critical care or intermediate care nurses caring primarily for neurotrauma patients; or 4 hours of neuro/trauma-related CE every year for nurses who care for trauma patients and are from other clinical areas; and Promote specialty certification for nurses working in the neurotrauma ICU and units within 3 years of assignment to neurotrauma. Nurses in the ICU shall spend 50 percent of their clinical practice caring for patients with neurologic injury. Neurotrauma nursing staff shall be involved with the centers injury prevention and outreach education programs. A neurotrauma center shall have: For emergency resuscitation: Immediate access to a computed tomography (CT) scanner; and Intracranial Pressure (ICP) monitoring equipment; In its operating room (OR): Neurotrauma-specific instrumentation/trays; Intraoperative ultrasound; and Evoked potential monitoring; A post-anesthesia care unit (PACU) with the necessary equipment and medications to manage the traumatic brain or spinal cord injured patient resuscitation and monitoring; In the ICU: ICP monitoring equipment; and Advanced Neuro-monitoring equipment; Radiological specialty capabilities, including: In-house trauma-dedicated technicians 24 hours a day; CT scan available 24 hours a day; and Access to magnetic resonance imaging (MRI) capability 24 hours a day; and Clinical laboratory service that meets the standards for PARC and Level I trauma center standard as specified in COMAR 30.08.05.15. A neurotrauma center shall: Have a rehabilitation program that is designed for neurotrauma patients and directed by a board-certified physiatrist; Meet rehabilitation requirements as follows: Rehabilitation services staffed by personnel trained in rehabilitative care and properly equipped for acute care of the traumatic brain injured or spinal cord injured patient; and Rehabilitation consultation services, appropriately licensed or registered in their specific disciplines (that is, occupational therapy, speech therapy, physical therapy, and social services), available in the critical care phase as needed; Provide therapists with regular supervision from individuals with at least 1 year of experience with the neuro injury for which the patient is being treated (that is, brain injury or spinal cord injury); Have an orientation program that documents therapists competencies specific to the treatment of acute neurologic injuries and require that each newly hired therapist complete the orientation program before assuming independent practice in the center; and Promote specialty certification for therapists working in the neurotrauma rehabilitation program. A neurotrauma center shall have: Transfer agreements to rehabilitation hospitals, for the primary three rehabilitation hospitals the trauma center utilizes, which may be joint transfer agreements if the trauma center is a part of a health system that utilizes a particular rehabilitation center with appropriate services tailored to the needs of traumatic brain and spinal cord injured patients; A referral process/case management plan for timely assessment for, and placement in, an appropriate rehabilitation program; Full in-house service or transfer process in place to a rehabilitation service for acute care or sub-acute care; and Ongoing continuity of care for patients with traumatic brain and spinal cord injuries provided in affiliated rehabilitation acute or sub-acute facilities, by attending neurotrauma center specialists and sub-specialists. A neurotrauma center shall have an ongoing QM program that is multidisciplinary and coordinated with the trauma QM program. The neurotrauma center director is responsible for the QM program for neurotrauma patients. A neurotrauma center shall: An organized neurotrauma research program and a documented research plan; Evidence of productivity through peer-reviewed publications; Proposals reviewed by an institutional review board; Presentations at local, regional, or national meetings; Publications in peer-reviewed journals on an average of six per year; and Clinical research trials designed to enhance the trauma system's ability to resuscitate, stabilize, and treat neurotrauma patients in the most cost-effective manner. A neurotrauma center shall: Provide outreach education to health care providers throughout the State related to current standards of care for neurotrauma patients; Participate in an ACGME-approved program for neurosurgical residency training; Serve as a clinical site for education for health care providers; and Participate in professional continuing education programs and professional meetings. The hospital shall have patient treatment and care documents as specified in COMAR 30.08.05.19 with the addition of: Resuscitation and treatment protocols/guidelines for traumatic brain injury; and Resuscitation and treatment protocols/guidelines for spinal cord injury. Education Article, §13-509, Annotated Code of Maryland Effective date: May 27, 2002 (29:10 Md. R. 827) Regulation .01 amended effective March 7, 2022 (49:5 Md. R. 368) Regulation .01D amended effective July 21, 2025 (52:14 Md R. 714) Regulation .02 amended effective March 7, 2022 (49:5 Md. R. 368) Regulation .03A, C amended effective March 7, 2022 (49:5 Md. R. 368) Regulation .04A amended effective March 7, 2022 (49:5 Md. R. 368) Regulation .05 amended effective March 7, 2022 (49:5 Md. R. 368) Regulation .06 amended effective March 7, 2022 (49:5 Md. R. 368) Regulation .07 amended effective March 7, 2022 (49:5 Md. R. 368) Regulation .08B, C amended effective March 7, 2022 (49:5 Md. R. 368) Regulation .09 amended effective March 7, 2022 (49:5 Md. R. 368) Regulation .10 amended effective March 7, 2022 (49:5 Md. R. 368) Regulation .11 amended effective March 7, 2022 (49:5 Md. R. 368) Regulation .13 amended effective March 7, 2022 (49:5 Md. R. 368) A designated primary stroke center hospital shall: Be licensed as an acute care hospital by the hospital licensing authority in the jurisdiction in which it is located; Be a hospital 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; If located in Maryland, be a base station approved under COMAR 30.03.06; Provide assessment and management of the stroke patient consistent with the most current AHA/ASA consensus based clinical practice guidelines to meet the needs of the patient; Have a stroke center medical director; Have a dedicated stroke center nurse coordinator; Have sufficient personnel and resources needed to facilitate healthcare data management and concurrent review of quality metrics and program objectives; Meet the requirements of Regulations .03—.14 of this chapter; Satisfy the MIEMSS requirements for designation as a primary stroke center; and Meet the requirements for a site review in COMAR 30.08.02.06, which may be satisfied by completing either: An on-site review by MIEMSS; or A site survey as part of The Joint Commission Disease Specific Care Certification Program for certification as a primary stroke center if the hospital: Authorizes The Joint Commission to provide MIEMSS with survey findings, certification reports, and other information related to The Joint Commission; Allows MIEMSS to participate in the accreditation site survey; and Provides MIEMSS any additional information required to determine it has satisfied the requirements for designation under this chapter. The hospital's board of directors, administrators, and medical and nursing staffs shall demonstrate commitment to the hospital's designation as a primary stroke center by: A board of directors' resolution stating that the hospital agrees to meet the standards of this chapter for designation as a primary stroke center; An organizational chart showing key stroke center personnel including the stroke center medical director and stroke center nurse coordinator and their relationship within the hospital; Establishing mechanisms to guide and assure cooperative relationships with community and professional groups committed to increasing public awareness and improving acute stroke care; Maintaining documentation of stroke center leadership including: An appointment letter for the stroke center medical director; and Curricula vitae of key stroke program personnel with training and expertise in cerebrovascular disease including: Physicians; A stroke center nurse coordinator; and Other key health care personnel; and Maintaining bylaws, contracts, and budgets specific to acute stroke care, indicating the hospital's commitment to the financial, human, and physical resources necessary to support the hospital's designation as a primary stroke center. The hospital shall maintain an emergency department which: Has written documentation on the process used to notify the stroke team of a patient with an acute stroke; and Has sufficient emergency department clinical staff to meet the requirements of Regulation .05. of this chapter. The hospital shall have: Operating room neurosurgical services available 24 hours a day with appropriately trained support staff, and: Necessary equipment and tools to aid in the care of acute stroke patients including equipment necessary for continuous hemodynamic monitoring; and A written plan for neurosurgical procedures or evaluations to be performed within 2 hours of the determination they are clinically necessary which is approved by: The neurosurgeons providing coverage; and The stroke center medical director; or A written agreement with another hospital which: Meets the requirements of this chapter; Has operating room neurosurgical facilities that meet the requirements of this regulation; and Is available to provide the required neurosurgical services to the patient. The hospital shall establish one or more acute stroke teams which shall respond to the emergency department with coordinated services for the effective delivery of emergency and acute stroke treatment. Presence at Bedside. A member of the emergency department clinical staff shall evaluate each patient with stroke-like symptoms within 10 minutes of the patient’s arrival at the emergency department. At least one member of the acute stroke team shall be present at the patient's bedside to provide care and to treat an acute stroke patient within 15 minutes of notification. The National Institutes of Health Stroke Scale (NIHSS) shall be used for the initial and serial assessment of patients with acute stroke. Clinicians performing an NIHSS will have documented training in the completion of the NIHSS. The acute stroke team shall include at a minimum: A physician with special competence in caring for the acute stroke patient who is Board certified or Board eligible in: Neurology; Critical care medicine; Emergency medicine; Family medicine; or Internal medicine; and At least one additional health care provider with experience in caring for the acute stroke patient who may be: An emergency physician; A family medicine physician; An internist; A neurology resident or fellow; A registered nurse; A physician's assistant; or A nurse practitioner. If the physician who satisfies §C(1) of this regulation is not Board certified or Board eligible in neurology, a Board certified or Board eligible neurologist shall be available within 15 minutes for consultation under the terms of a written agreement by: Telephone; or Audio/visual communication. The hospital shall: Transfer the clinically appropriate stroke patient requiring a higher level of care after initial treatment and stabilization to a MIEMSS designated primary stroke center that has endovascular capability or a MIEMSS designated comprehensive stroke center; and Maintain an agreement or agreements with a commercial ambulance service to: Transfer stroke patients as clinically necessary; Ensure the appropriate delivery of care during transport; and Limit utilization of local emergency medical services (EMS) resources unless by pre-existing agreement. The hospital shall maintain a stroke unit that meets the requirements of this regulation which: Has designated beds for the care of acute stroke patients beyond the acute treatment period; Provides care to acute stroke patients through qualified clinical staff who meet the requirements in Regulation .09 of this chapter; Develops a standardized process originating in clinical practice guidelines or evidence-based practice to deliver or facilitate the delivery of clinical care; Develops an individualized plan of care that is based on the patient’s assessed needs and reflects coordination of care with other programs as determined by patient comorbidities; and Maintains written documentation delineating the function of the stroke unit including: Admission criteria; Discharge criteria; Acute stroke care protocols; Interdisciplinary rounding; Patient census; Rehabilitation in the hospital; Rehabilitation after discharge; and Outcomes data. The hospital shall have the ability 24 hours a day to perform laboratory and diagnostic services within 45 minutes of written order including, but not limited to: A complete blood count; Blood chemistries; Coagulation studies; Troponin; Electrocardiograms; and Chest radiographs. The hospital shall have the ability 24 hours a day, within 20 minutes of the patient’s arrival, to complete: All of the following: Brain computed tomography; CT Angiography; and CT Perfusion; or Magnetic resonance imaging. The hospital shall have the ability 24 hours a day to have the neuroimages referred to in this regulation interpreted within 20 minutes of their completion by a physician experienced in interpreting computed tomographic studies. The hospital shall have the ability 24 hours a day to have the neuroimages referred to in this regulation interpreted within 30 minutes of their completion by a physician experienced in interpreting: CT angiography; CT Perfussion; and Magnetic resonance imaging studies. The hospital shall: Have the ability to upload emergent imaging scans into CRISP (Chesapeake Regional Information System for our Patients), which will facilitate sharing of emergent imaging with the receiving center; and Have the imaging ability to rapidly identify core (nonviable) infarct versus (potentially salvageable) penumbra. The stroke center medical director shall be a physician with special competence in caring for the acute stroke patient who is Board certified or Board eligible in: Neurology; Emergency medicine; Neurosurgery; Neuro interventional radiology; or Internal medicine. The stroke center medical director’s qualifications shall include: Active participation in the stroke Quality Improvement Council (QIC); and 8 hours of category 1 CME credits related to stroke care annually. Qualifications for stroke center physicians who care for acute stroke patients shall include 4 or more hours of category 1 or 2 CME credits per year related to stroke care. Training for non-physician stroke center professional staff who care for acute stroke patients shall include 4 or more hours per year of continuing education in areas related to cerebrovascular disease. Emergency department clinical staff shall participate in cerebrovascular disease educational activities at least two times a year if they: Triage patients in the emergency department; or Care for acute stroke patients. Emergency department clinical staff who triage patients in the emergency department or care for acute stroke patients shall be trained in: Diagnosis of acute stroke; Treatment of acute stroke; and Use of clinically appropriate fibrinolytics and educated on the indication and referral for endovascular therapy in acute ischemic stroke. Surviving acute stroke patients and their families shall receive instruction on: Signs and symptoms of acute stroke, including the importance of activating EMS; Effects and prognosis of acute stroke; Potential complications of acute stroke; Needs and rationales for treatment; Patient compliance instructions for risk reduction of individual risk factors and secondary prevention programs; and Post-stroke support services. The hospital shall support or participate, or both, in acute stroke educational activities developed for EMS personnel which are conducted at least once a year. The hospital shall conduct at least two times per year public education programs on: Stroke prevention; Recognition of signs and symptoms of acute stroke and the need to activate EMS; Diagnosis of acute stroke; and Treatment of acute stroke. The hospital shall develop and implement: A written policy which demonstrates that the hospital has established the stroke center to: Monitor the care delivered to acute stroke patients; Improve the quality of care delivered to acute stroke patients; Move patients through the initial acute care phase of their hospital stay in a timely fashion; and Ensure that all stroke patients will receive medical care commensurate with the hospital's designation as a primary stroke center; Written procedures for rapidly activating the stroke team to care for potentially eligible fibrinolytic and endovascular candidates within 15 minutes of notification; and Written care protocols for the treatment of acute stroke which: Address: Evaluation of each patient by a member of the emergency department clinical staff within 10 minutes of the patient's arrival at the hospital emergency department; At least one member of the stroke team arriving at the acute stroke patient's bedside within 15 minutes of notification; Ischemic stroke; Hemorrhagic stroke; Stabilization of vital functions; Initial diagnostic tests; The use of medications including fibrinolytics; Care of the potential endovascular candidate; Timely and safe patient transfer; and The hospital's plan for updating the protocols at least annually; Are maintained up-to-date in: The emergency department; The stroke unit; The intensive care unit; and All other locations where stroke care is provided. The hospital shall participate, in a manner approved by the EMS Board, in a stroke registry that includes the data elements tracked by the Centers for Medicare and Medicaid Services and the American Heart/American Stroke Get With the Guidelines® — Stroke Registry. The hospital shall authorize the stroke registry to provide the hospital's data to MIEMSS for health oversight activities in a manner approved by the EMS Board. Outcome Objectives. The hospital shall establish at least 2 outcome objectives that are: Time-specific; Measurable; Reflective of tracking and trending of performance measures and indicators; and Reviewed in annual comparison studies. The hospital shall monitor IV fibrinolytic complications, which include symptomatic intracerebral hemorrhage and serious life-threatening systemic bleeding. The hospital shall monitor and demonstrate tracking and trending of modified Rankin Scores (mRS) at discharge and at 90 days post-discharge on patients with acute ischemic stroke. The hospital shall establish at least one stroke center quality assurance medical review committee which shall be a medical review committee under Health Occupations Article, §1-401, Annotated Code of Maryland, as a committee established in the Maryland Institute for Emergency Medical Services Systems which, at least three times a year: Meets; Reviews practice patterns; and Modifies practice patterns as appropriate. In cases where the administration of fibrinolytics is appropriate, the hospital shall administer fibrinolytics within 60 minutes from the time the patient arrives at the emergency department for greater than or equal to 50 percent of eligible patients. The hospital shall demonstrate progress towards administering fibrinolytics within 60 minutes from the time the patient arrives at the emergency department for greater than or equal to 75 percent of eligible patients. The hospital shall demonstrate progress towards reducing time of administration of fibrinolytics to 45 minutes for greater than or equal to 50 percent of eligible patients. The hospital shall incorporate into the hospital’s quality assurance process progress reports about: Specific acute stroke treatment benchmarks; Outcomes data on patients transferred for higher level of care; and Stroke treatment quality improvement goals. The hospital shall provide MIEMSS with documentation of quality management of the stroke program for review including, if appropriate: Problem identification; Problem analysis; An action plan; Implementation of the plan; and Reevaluation of the plan. Education Article, §13-509, Annotated Code of Maryland Effective date: June 5, 2006 (33:11 Md. R. 952) Regulation .06B amended effective June 4, 2007 (34:11 Md. R. 973) Chapter revised effective July 1, 2021 (48:9 Md. R. 360) Regulation .01B amended effective July 21, 2025 (52:14 Md. R. 714) Regulation .15 repealed effective October 18, 2021 (48:21 Md. R. 892) In this chapter, the following terms have the meanings indicated. Terms Defined. “Capability” means having the necessary equipment and supplies as well as staff with the skill and experience in its use. “Current” means generally accepted, used, practiced, or prevalent at the moment. “Dedicated” means a resource is assigned to or for the exclusive use by a unit and not shared with any other unit “E” means the standard is essential. “O” means the standard is optional. “NA” means the standard does not apply. “Programmatic responsibility” means the writing, review, and maintenance of practice guidelines, policies, and procedures; development of the operating budget in collaboration with hospital administration and other program directors; evaluation and guiding of the purchase of equipment; planning, development, and coordinating of educational programs, both in-hospital and outreach; participation in the evaluation of perinatal care; and participation in perinatal quality improvement and patient safety activities. “Readily available” means a resource is available for use a short time after it is requested. “Telemedicine” means the use of interactive audio, video, or other telecommunications or electronic technology by a licensed health care provider to deliver a health care service within the scope of practice of the health care provider at a site other than the site at which the patient is located, in compliance with COMAR 10.32.05.and including at least two forms of communication. “Thirty (30) minutes” means in-house within thirty (30) minutes under normal driving conditions which include, but are not limited to, weather, traffic, and other circumstances which may be beyond the individual’s control. “III” is a Level III perinatal referral center. “IV” is a Level a Level IV perinatal referral center. III IV A. The hospital’s Board of Directors, administration, and medical and nursing staffs shall demonstrate commitment to its specific level of perinatal center designation and to the care of perinatal patients. This commitment shall be demonstrated by: (1) A Board resolution that the hospital agrees to meet the current Maryland Perinatal System Standards for its specific level of designation and assures that all perinatal patients shall receive medical care commensurate with that designation; E E (2) Submission of patient care data to the Maryland Department of Health (MDH) and the Maryland Institute for Emergency Medical Services Systems (MIEMSS), for system and quality management; and E E (3) A Board resolution, bylaws, contracts, and budgets indicating the hospital’s commitment to the financial, human, and physical resources and to the infrastructure that are necessary to support the hospital’s level of perinatal center designation. E E B. The hospital shall be licensed by the Maryland Department of Health (MDH) as an acute care hospital. E E C. The hospital shall 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. E E D. The hospital shall have an agreement with the Health Services Cost Review Commission that addresses how the cost of neonatal intensive care services will be incorporated into the hospital’s population health budget, and the hospital shall have a certificate of need (CON) from the Maryland Health Care Commission (MHCC) in order to provide neonatal intensive care services, defined as a Level III or IV perinatal program, unless establishment of the hospital’s neonatal intensive care services preceded this requirement. A hospital shall obtain a CON in order to establish Level III or IV perinatal program or to expand a Level III perinatal program to Level IV. E E E. The hospital shall obtain and maintain current equipment and technology, as described in these standards, to support optimal perinatal care for the level of the hospital’s perinatal center designation. E E F. If maternal or neonatal air transports are accepted, then the hospital shall have a heliport, helipad, or access to a helicopter landing site near the hospital. E E G. The hospital shall provide specialized maternal and neonatal transport capability and have extensive Statewide perinatal educational outreach programs in both specialties in collaboration with the Maryland Institute for Emergency Medical Services Systems (MIEMSS) and the Maryland Department of Health (MDH). O E III IV A hospital shall: A. Demonstrate its capability of providing obstetrical care through written standards, protocols, or guidelines, including those for the following: (1) Management of uncomplicated pregnancy; E E (2) Detection, stabilization, and initiation of management of unanticipated maternal-fetal problems; E E (3) Fetal monitoring, including internal scalp electrode monitoring; E E (4) Ability to begin emergency cesarean delivery within a time interval that best incorporates maternal and fetal risks and benefits with the provision of emergency care; and E E (5) Selection and management of obstetrical patients at a maternal risk level appropriate to its capability. E E B. Have an on-site intensive care unit that accepts obstetrical patients and has critical care providers on-site to actively collaborate with obstetricians or maternal-fetal medicine specialists at all times. E E III IV A hospital shall demonstrate its capability of providing neonatal care through written standards, protocols, or guidelines, including those for the following: A. Resuscitation and stabilization of the neonate according to the current American Academy of Pediatrics/American Heart Association (AAP/AHA) Neonatal Resuscitation Program (NRP) guidelines at every delivery; E E B. Detection, stabilization, and initiation of management of unanticipated neonatal problems; E E C. Evaluation and care of stable term newborn infants. E E III IV A hospital shall have: A. A physician board-certified in obstetrics/gynecology shall be a member of the medical staff and have programmatic responsibility for obstetrical services; E NA B. A physician board-certified in maternal-fetal medicine shall be a member of the medical staff and have programmatic responsibility for obstetrical services; O E C. A physician board-certified in maternal-fetal medicine shall be a member of the medical staff and have programmatic responsibility for high-risk obstetrical services; E E D. A physician board-certified in anesthesiology shall be a member of the medical staff and have programmatic responsibility for obstetrical anesthesia services; E E E. A physician board-certified or an active candidate for board certification in maternal-fetal medicine on the medical staff, in active practice available at all times and, if needed, in-house within 30 minutes; and E E F. A physician board-certified or an active candidate for board-certification in obstetrics/gynecology shall be present in-house 24 hours a day and immediately available to the delivery area when a patient is in active labor. E E III IV A hospital shall have: A. A physician board-certified in pediatrics, neonatal-perinatal medicine, or family medicine shall be a member of the medical staff and have privileges for neonatal care and have programmatic responsibility for neonatal services in the newborn nursery and/or the mother-baby unit; E E B. A physician board-certified in neonatal-perinatal medicine shall be a member of the medical staff and have programmatic responsibility for neonatal services in the special care nursery or NICU; E E C. Neonatal Resuscitation Program (NRP) trained professional(s) with experience in acute care of the depressed newborn and skilled in neonatal endotracheal intubation and resuscitation shall be immediately available to the delivery and neonatal units; E E D. A physician who has completed postgraduate pediatric training, a nurse practitioner, or a physician assistant with privileges for neonatal care appropriate to the level of the nursery and who shall be present in-house 24 hours a day and assigned to the delivery area and neonatal units and not shared with other units in the hospital; E E E. A physician board-certified or an active candidate for board certification in neonatal-perinatal medicine shall be on the medical staff, in active practice, available at all times, and, if needed, in-house within 30 minutes; E E F. An ophthalmologist with experience in neonatal retinal examination and an organized program for the monitoring, treatment, and follow up of retinopathy of prematurity; E E G. The following pediatric subspecialists on staff, in active practice, and, if needed, readily available in-house or via telemedicine: (1) Cardiology; (2) Neurology; and (3) General Pediatric Surgery; E NA H. The following pediatric subspecialties on staff, in active practice, available at all times, and, if needed, in-house within 30 minutes: cardiology, endocrinology, gastroenterology, genetics, hematology, nephrology, neurology, and pulmonology; and O E I. General Pediatric Surgery and the following pediatric surgical subspecialists on staff, in active practice, available at all times, and, if needed, in-house within 30 minutes: (1) Neurosurgery; (2) Cardiothoracic surgery; (3) Orthopedic surgery; (4) Plastic surgery; and (5) Ophthalmology. O E III IV A hospital shall have: A. A physician board-certified or an active candidate for board certification in anesthesiology or nurse-anesthetist who shall be available at all times to provide labor analgesia and surgical anesthesia so that cesarean delivery may be initiated per hospital protocol as required by Regulation .04A of this chapter; E E B. A physician board-certified or an active candidate for board-certification in anesthesiology who shall be present in-house 24 hours a day, readily available to the delivery area; E E C. If the hospital performs neonatal surgery, a physician board-certified or an active candidate for board certification in anesthesiology with experience in neonatal anesthesia who shall be present for the surgery; E E D. A physician on the medical staff with privileges for providing critical interventional radiology services for: (1) Obstetrical patients; and E E (2) Neonatal patients; O E E. On staff, a licensed registered dietician with knowledge of and experience in the management of obstetrical and neonatal parenteral/enteral nutrition; E NA F. On staff, a licensed registered dietician with knowledge of and experience in the management of obstetrical and neonatal parenteral/enteral nutrition, with one dietician dedicated to the NICU; O E G. At least one full-time equivalent International Board Certified Lactation Consultant who shall have programmatic responsibility for lactation support services which shall include education and training of additional hospital staff members in order to ensure availability of lactation support 7 days per week; E E H. A written plan to address lactation consultant/patient ratios recommended in the current Association of Women’s Health, Obstetric, and Neonatal Nurses Guidelines; E E I. At least one licensed social worker with a Master’s degree (either an LMSW, Licensed Master Social Worker, or an LCSW, Licensed Certified Social Worker) and experience in psychosocial assessment and intervention with women and their families dedicated to the perinatal service; E E J. At least one licensed social worker with a Master’s Degree (either an LMSW, Licensed Master Social Worker, or an LCSW, Licensed Certified Social Worker) and experience in psychosocial assessment and intervention with women and their families dedicated to the NICU; K. Respiratory therapists skilled in neonatal ventilator management; (1) Present in-house 24 hours a day; and E NA (2) Dedicated to the NICU 24 hours a day; O E L. At least one occupational or physical therapist with neonatal expertise; E E M. At least one individual skilled in evaluation and management of neonatal feeding and swallowing disorders such as a speech-language pathologist; E E N. Genetic diagnostic and counseling services or written consultation and referral agreements for these services in place; E E O. A pediatric neurodevelopmental follow-up program or written referral agreements for neurodevelopmental follow-up; E E P. Pharmacy personnel with knowledge of and experience in pediatric pharmacy; E E Q. Hospital perinatal program shall have on its administrative staff at least one registered nurse with a Master’s degree or higher degree in nursing or a health-related field and experience in high-risk obstetrical and/or neonatal nursing who shall have programmatic responsibility for the obstetrical and neonatal nursing services; E E R. On its perinatal program staff at least one registered nurse with a Master’s or higher degree in nursing or a health or education-related field and experience in high-risk obstetrical and/or neonatal nursing who shall have programmatic responsibility for the obstetrical and neonatal nursing services; E E S. Hospital perinatal program shall have on its staff at least one registered nurse with a Master’s or higher degree in nursing or a health or education-related field and experience in high-risk obstetrical and/or neonatal nursing responsible for staff education; E E T. Obstetrical service shall have continuous availability of adequate numbers of registered nurses with competence in assessment and care of obstetrical patients as well as the recognition and nursing management of obstetrical complications; E E U. Neonatal service shall have continuous availability of adequate numbers of registered nurses with competence in assessment and care of neonatal patients appropriate to the designated level of care; E E V. Neonatal service shall have continuous availability of adequate numbers of registered nurses with competence in assessment and care of neonatal patients appropriate to the designated level of care; E E W. A written plan to address registered nurse/patient ratios recommended in the current Association of Women’s Health, Obstetric, and Neonatal Nurses Guidelines. E E III IV A hospital shall: A. The programmatic leaders of the perinatal service and the hospital laboratory shall establish laboratory processing and reporting times that are appropriate for samples drawn from obstetrical and neonatal patients with specific consideration for the acuity of the patient and the integrity of the samples. E E B. Demonstrate the capability to immediately receive, process, and report urgent/emergent obstetric and neonatal laboratory requests. E E C. Have a process in place to report critical results to the obstetric and neonatal services. E E D. Make laboratory results from standard maternal antepartum testing available to the providers caring for the mother and the neonate prior to discharge. If test results are not available or if testing was not performed prior to admission, such testing shall be performed during the hospitalization of the mother and results available prior to discharge of the newborn. E E E. Have the capacity to conduct rapid HIV testing 24 hours a day. E E F. Have available the equipment and trained personnel to perform newborn hearing screening prior to discharge on all infants born at or transferred to the institution as required by COMAR 10.11.02. E E G. Have available the equipment and trained personnel to perform critical congenital heart disease screening between 24 and 48 hours of age on all well infants born at or transferred to the institution and report screening results as required by COMAR 10.52.15. E E H. Have a protocol to perform critical congenital heart disease screening on all infants in the special care nursery or neonatal intensive care unit born at or transferred to the institution and to report screening results as required by COMAR 10.52.15. E E I. Have available the equipment and trained personnel to collect newborn blood-spot screening on all infants born at or transferred to the institution at the appropriate time/intervals and to transport blood-spot specimens to the Maryland State Newborn Screening Laboratory as required by COMAR 10.52.12 and 10.10.13.14. E E J. Have blood bank technicians present in-house 24 hours a day. E E K. Have molecular, cytogenetic, and biochemical genetic testing. E E III IV A hospital shall have: A. The capability of providing emergency ultrasound imaging and interpretation for obstetrical patients 24 hours per day; E E B. The capability of providing detailed ultrasonography and fetal assessment, including Doppler studies, with interpretation for obstetrical patients 24 hours a day; E E C. The capability of providing maternal echocardiology with interpretation for obstetrical patients 24 hours a day; E E D. The capability of providing portable x-ray imaging with interpretation for neonatal patients 24 hours a day; E E E. The capability of providing portable head ultrasound with interpretation for neonatal patients; E E F. The capability on campus of providing computerized tomography (CT) and magnetic resonance imaging (MRI) with interpretation; O E G. Neonatal echocardiography equipment and an experienced technician shall be available on campus as needed with interpretation by a pediatric cardiologist; E E H. A pediatric cardiac catheterization laboratory and appropriate staff; and O E I. The capability of providing interventional radiology services for: (1) Obstetrical patients; and E E (2) Neonatal patients. O E III IV A hospital shall have: A. All of the following equipment and supplies immediately available for existing patients and for the next potential patient: (1) O2 analyzer, stethoscope, intravenous infusion pumps; (2) Radiant heated bed in delivery room and available in the neonatal units; (3) Oxygen hood with humidity; (4) Bag and masks and/or T-piece resuscitator capable of delivering a controlled concentration of oxygen to the infant; (5) Orotracheal tubes; (6) CO2 detector; (7) Aspiration equipment; (8) Laryngoscope; (9) Bowel bags; (10) Umbilical vessel catheters and insertion tray; (11) Cardiac monitor; (12) Pulse oximeter; (13) Transilluminator; (14) Phototherapy unit; (15) Doppler blood pressure for neonates; (16) Cardioversion/defibrillation capability for obstetrical patients and neonates; (17) Resuscitation equipment for obstetrical patients; (18) Resuscitation equipment for neonates including equipment outlined in the current NRP; (19) Individual oxygen, air, and suction outlets for obstetrical patients and neonates; and (20) Emergency call system for both obstetrical and neonatal units as well as an emergency communication system among units. E E B. Special equipment and facilities needed to accommodate the care and services needed for obese women. E E C. A neonatal stabilization bed set up and equipment available at all times for an emergency admission; E E D. Fetal diagnostic testing and monitoring equipment for: (1) Fetal heart rate monitoring; E E (2) Ultrasound examinations; and E E (3) Amniocentesis; E E E. The capability to monitor neonatal intra-arterial pressure; E E F. The capability on campus of providing laser coagulation for retinopathy of prematurity; E E G. The capability on campus of providing a full range of invasive maternal monitoring including equipment for central venous pressure and arterial pressure monitoring; E E H. Appropriate equipment, including back-up equipment, for neonatal respiratory care as well as protocols for the use and maintenance of the equipment as required by its level of neonatal care; E E I. The capability of providing advanced ventilatory support, beyond conventional mechanical ventilation, for neonates of all birth weights; and O E J. The capability of providing continuing therapeutic hypothermia. O E III IV A hospital shall have: A. Emergency medications, as listed in the current Neonatal Resuscitation Program (NRP) guidelines, shall be immediately available in the delivery area and neonatal units; E E B. The following medications shall be immediately available to the neonatal units: (1) Antibiotics, anticonvulsants, and emergency cardiovascular drugs; and E E (2) Surfactant, prostaglandin E1; E E C. All emergency resuscitation medications to initiate and maintain resuscitation, in accordance with current Advanced Cardiac Life Support (ACLS) guidelines of the American Heart Association (AHA), shall be immediately available in the delivery area; E E D. The following medications shall be immediately available for management of obstetrical hemorrhage in the delivery area and postpartum floor: (1) Oxytocin (Pitocin); (2) Methylergonovine (Methergine); (3) Misoprostol (Cytotec); (4) Carboprost tromethamine (Hemabate); (5) Tranezamic acid (TXA); and E E E. The following medications shall be immediately available for management of hypertensive crisis in all obstetrical care areas: (1) Hydralazine; (2) Labetalol; and (3) Nifedipine. E E III IV A hospital shall: A. Identify minimum competencies for obstetrical and neonatal clinical staff, not otherwise credentialed, that are assessed prior to independent practice and on a regular basis thereafter; E E B. Provide continuing education programs available to all obstetrical and neonatal clinical staff concerning the treatment and care of obstetrical and neonatal patients; E E C. Conduct multidisciplinary clinical drills or simulations including post-drill debriefs to help prepare obstetrical and neonatal staff for high risk, high complexity, low frequency events; E E D. Provide evidence-based education every two years to all staff caring for newborns (nurses, respiratory therapist, technicians, etc.) that includes at a minimum stabilization after immediate resuscitation to address glucose metabolism, thermoregulation, respiratory support hemodynamic monitoring and stability, risk and treatment of infection, and support for the family; and E E E. Accept maternal or neonatal primary transports and provide the following to the referring hospital/providers: (1) Guidance on indications for consultation and referral of patients at high risk; (2) Information about the accepting hospital’s response times and clinical capabilities; (3) Information about alternative sources for specialized care not provided by the accepting hospital; (4) Guidance on the pre-transport stabilization of patients; and (5) Feedback on the pre-transport and post-transport care of patients. E E III IV A hospital shall: A. Have a multi-disciplinary Perinatal Quality Improvement Program which meets at least quarterly to evaluate maternal and neonatal health outcomes and to identify process changes to improve patient safety and perinatal outcomes. E E B. The Perinatal Quality Improvement Program shall conduct internal case reviews, collect and analyze perinatal program data, conduct trend analyses, set quality improvement goals annually, and use data to assess progress toward those goals. E E C. The Perinatal Quality Improvement Program shall conduct reviews of all cases of the following as well as cases related to other patient safety and systems issues identified: (1) Maternal, intrapartum fetal, and neonatal deaths; (2) Transports to a higher or comparable level of care; and (3) Elective delivery at less than 39 weeks gestation. E E D. Participate with the Maryland Department of Health and local health department Fetal and Infant Mortality Review program. E E E. Participate in the collaborative collection and assessment of data with the Maryland Department of Health and/or the Maryland Institute for Emergency Medical Services Systems, for the purpose of improving perinatal health outcomes. E E F. Maintain membership in the Vermont Oxford Network. E E III IV A hospital shall have: A. Written policies and protocols for the initial stabilization and continuing care of all obstetrical and neonatal patients appropriate to the designated level of care; E E B. Maternal and neonatal resuscitation protocols; E E C. A medical staff credentialing process that shall include documentation of competency to perform obstetrical and neonatal invasive procedures appropriate to its designated level of care; E E D. A written protocol for the initiating maternal and neonatal transports to an appropriate level of care; E NA E. A written protocol for the acceptance of maternal and neonatal transports; E E F. Written protocols for accepting or transferring obstetrical patients or neonates as “back transports”; E E G. A licensed neonatal transport service or written agreement with a licensed neonatal transport service; E E H. Policies that allow families (including siblings) to be together in the hospital following the birth of an infant and that promote parental involvement in the care of the neonate including those in the NICU; E E I. A policy to eliminate deliveries by induction of labor or by cesarean section prior to 39 weeks gestation without a medical indication with a systematic internal review process to evaluate any occurrences and a plan for corrective action; J. Written protocols and capabilities in place for the following: (1) Assessment of risk for obstetrical hemorrhage; (2) Maximizing accuracy in determining obstetrical blood loss; (3) Massive transfusion; (4) Emergency release of blood products before full compatibility testing is complete; and (5) Management of multiple component therapy; E E K. Written protocol to evaluate all infants born at or transferred to the institution for birth defects and to report findings to the Birth Defects Reporting and Information System as required by Health-General Article, §18-206, Annotated Code of Maryland; E E L. Written policy for the management of obstetrical patients with opioid use and opioid use disorder that addresses the following and other relevant issues: (1) Universal screening of obstetrical patients for opioid use; (2) Pharmacotherapy of the pregnant, laboring, and postpartum patient; (3) Breastfeeding; (4) Linkages to appropriate postpartum psychosocial support services including substance use treatment and relapse prevention program; and (5) Reproductive health planning; E E M. Written policy for the identification and management of neonatal abstinence syndromes; E E N. Written policy for optimizing post-delivery care of obstetrical patients that addresses the following and other relevant issues: (1) Identification of postpartum patients at risk for poor health outcomes; (2) Breastfeeding support; (3) Linkages to appropriate medical and psychosocial services; and (4) Reproductive health planning; E E O. Written policy to address infant safety issues including safe sleep, abusive head trauma (shaken baby) and car seat safety. E E Education Article, §13-509, Annotated Code of Maryland Effective date: March 24, 1997 (24:6 Md. R. 488) Regulation .03A, D amended effective July 1, 2002 (29:12 Md. R. 934) Regulation .04A, C amended effective August 7, 2000 (27:15 Md. R. 1403) Regulation .05A amended effective August 7, 2000 (27:15 Md. R. 1403) Regulation .06 repealed and new Regulation .06 adopted effective August 7, 2000 (27:15 Md. R. 1403) Regulation .07A—D amended effective August 7, 2000 (27:15 Md. R. 1403) Regulation .08 amended effective August 7, 2000 (27:15 Md. R. 1403) Regulation .09A amended effective August 7, 2000 (27:15 Md. R. 1403) Regulation .10 amended effective August 7, 2000 (27:15 Md. R. 1403) Regulation .11 amended effective August 7, 2000 (27:15 Md. R. 1403) Chapter revised effective May 15, 2005 (32:9 Md. R. 850) Regulations .01—.15 repealed and new Regulations .01—.15 adopted effective January 13, 2011 (38:1 Md. R. 12) Regulations .01—.15 amended effective March 30, 2015 (42:6 Md. R. 514) Regulation .01B amended effective October 3, 2022 (49:20 Md. R. 913) Regulation .03 amended effective October 3, 2022 (49:20 Md. R. 913) Regulation .03C amended effective July 21, 2025 (52:14 Md. R. 714) Regulation .04 amended effective October 3, 2022 (49:20 Md. R. 913) Regulation .05 amended effective October 3, 2022 (49:20 Md. R. 913) Regulation .06 amended effective October 3, 2022 (49:20 Md. R. 913) Regulation .07 amended effective October 3, 2022 (49:20 Md. R. 913) Regulation .08 amended effective October 3, 2022 (49:20 Md. R. 913) Regulation .09 amended effective October 3, 2022 (49:20 Md. R. 913) Regulation .10 amended effective October 3, 2022 (49:20 Md. R. 913) Regulation .11 amended effective October 3, 2022 (49:20 Md. R. 913) Regulation .11I amended effective December 10, 2015 (42:24 Md. R. 1506) Regulation .12 amended effective October 3, 2022 (49:20 Md. R. 913) Regulation .13 amended effective October 3, 2022 (49:20 Md. R. 913) Regulation .14 amended effective October 3, 2022 (49:20 Md. R. 913) Regulation .15 amended effective October 3, 2022 (49:20 Md. R. 913) MIEMSS may take disciplinary action against a designated trauma or specialty referral center if the trauma or specialty referral center: Is out of compliance with the requirements of this subtitle, and has been unable or has refused to comply as required by MIEMSS; Fails to comply with, or otherwise violates the provisions of, State or federal law; Fails to provide data to MIEMSS, as required by COMAR 30.08.03.01; Makes a false statement or omits a material fact in: Its application for designation, A record required by this subtitle, or A matter under investigation; Prevents, interferes with, or attempts to impede in any way, the work of a representative of MIEMSS in the lawful enforcement of this subtitle or any other applicable State law; Uses false, fraudulent, or misleading advertising, or makes any public claims regarding the center's ability to care for nontrauma or nonspecialty care patients based on its trauma or specialty referral center designation status; or Fails to cooperate in providing documentation and interviews with appropriate staff for MIEMSS' investigation of complaints. Receipt of Information. MIEMSS shall initiate a preliminary investigation if it receives information that might form the basis for action against a trauma or specialty referral center. A person may file a signed, written complaint with the Office of Hospital Programs regarding an alleged violation of this subtitle. MIEMSS may begin an investigation without a signed written complaint if it determines that sufficient cause exists. MIEMSS may initiate a further investigation if it needs additional information to determine whether disciplinary action is warranted. Not later than 10 business days after MIEMSS decides to begin an investigation, MIEMSS shall give written notice of the investigation to the trauma or specialty referral center being investigated, unless extenuating circumstances exist that would reasonably preclude notification. At the conclusion of MIEMSS' investigation, MIEMSS shall report its findings, in writing, to the chief executive officer of the trauma or specialty referral center, including requirements for corrective action, if MIEMSS determines that corrective action is appropriate. MIEMSS shall take reasonable precautions to ensure that an investigation is conducted in a confidential manner. MIEMSS shall maintain a record for each designated trauma and specialty referral center in Maryland. If MIEMSS begins an investigation, it shall create a confidential record containing the investigatory material, which: Is exempt from disclosure under Health Occupations Article, §§1-401 and 14-506, Annotated Code of Maryland, and General Provisions Article, Title 4, Subtitle 3, Annotated Code of Maryland; and Shall be placed in the designated trauma or specialty referral center's official record. A request for records maintained by MIEMSS shall be processed under Health Occupations Article, §§1-401 and 14-506, Annotated Code of Maryland, and General Provisions Article, Title 4, Subtitle 3, Annotated Code of Maryland. If MIEMSS finds that a trauma or specialty referral center has violated this subtitle, MIEMSS may: Require a trauma or specialty referral center to submit a plan of corrective action; Place a designated trauma or specialty referral center on probation; Lower a trauma center's level of designation; Suspend a trauma or specialty referral center's designation; or Revoke a trauma or specialty referral center's designation. If MIEMSS requires a trauma or specialty referral center to submit a plan of corrective action, the notice required by Regulation .02D of this chapter shall include a deadline for submission of the plan of corrective action by the trauma or specialty referral center. The plan shall include: Steps that the trauma or specialty referral center intends to take to correct deficiencies; and The projected date of completion. Not later than 15 business days after it receives the plan, MIEMSS shall: Decide whether to approve the plan; and Provide written notice of its decision to the trauma or specialty referral center. If MIEMSS disapproves the plan, not later than 15 business days from the date of disapproval, the trauma or specialty referral center may request an informal meeting in accordance with Regulation .06D of this chapter. If MIEMSS approves the plan of correction, the trauma or specialty referral center shall: Begin implementation of the plan immediately upon receiving notice of approval; and Notify MIEMSS upon completion of the plan. Review of Compliance with Plan. MIEMSS may conduct an on-site review to determine whether the trauma or specialty referral center has complied with the plan of correction. If MIEMSS determines that the trauma or specialty referral center has satisfactorily complied with the plan, the trauma or specialty referral center shall retain its designation status. If MIEMSS determines that the trauma or specialty referral center has not satisfactorily complied with the plan, MIEMSS may take further disciplinary action against the trauma or specialty referral center under Regulation .06 of this chapter. MIEMSS shall initiate an action to place a trauma or specialty referral center on probation or to lower, suspend, or revoke a trauma or specialty referral center's designation if MIEMSS: Determines that the violation warrants probation, lowered level of designation, suspension, or revocation; or Has required a plan of corrective action, and: The trauma or specialty referral center fails to submit a plan within the time set by MIEMSS, or MIEMMS determines that the trauma or specialty referral center has not satisfactorily complied with the plan. Notice of Action. MIEMSS shall notify a trauma or specialty referral center of the disciplinary action by issuing a written notice of suspension, revocation, lowered level of designation, or probation to the chief executive officer of the hospital. The notice of suspension, revocation, lowered level of designation, or probation shall conform to State Government Article, §10-207, Annotated Code of Maryland. MIEMSS shall notify the EMS Board of the action taken. Except in the case of an emergency suspension or revocation under §F of this regulation, the suspension, revocation, lowered level of designation, or probation is stayed pending the final agency decision. Informal Meeting. Not later than 15 business days from the date a trauma or specialty referral center receives a notice of suspension, revocation, lowered level of designation, or probation, the trauma or specialty referral center may request, in writing, an informal meeting with MIEMSS to discuss MIEMSS' action. The meeting shall be held not later than 10 business days from the date MIEMSS receives the request. If the trauma or specialty referral center does not timely request an informal meeting, MIEMSS' notice of suspension, revocation, lowered level of designation, or probation is the final agency decision. Request for Hearing. This section does not apply to an emergency revocation or suspension hearing under §F of this regulation. If the trauma or specialty referral center is not satisfied with the result of the informal meeting, not later than 15 business days from the date of the meeting, it may request a hearing by sending a written request for a hearing by certified mail, return receipt requested, addressed to the MIEMSS Office of Hospital Programs in Baltimore, Maryland. Not later than 5 business days from the date of receipt of a timely request for a hearing, MIEMSS shall forward the request to OAH. From the date OAH receives the hearing request, OAH shall schedule a hearing as soon as practicable for all parties and OAH, but not later than: 60 calendar days for temporary suspensions or revocations; or 90 calendar days for all other hearings. The hearing is conducted in accordance with the procedures set forth in §G of this regulation. If the trauma or specialty referral center does not request a hearing in a timely manner, MIEMSS' notice of suspension, revocation, lowered level of designation, or probation is the final agency decision. Emergency Revocation or Suspension. If MIEMSS determines that grounds exist that require immediate suspension or revocation of designation for the public's protection, MIEMSS may issue a notice of immediate suspension or revocation of designation to the chief executive officer of the trauma or specialty referral center. The suspension or revocation of designation is effective immediately upon service of the notice of immediate suspension or revocation of designation. Request for Hearing. Not later than 15 business days after service of the notice of immediate suspension or revocation of designation, the trauma or specialty referral center may request a hearing by sending a written request for a hearing by certified mail, return receipt requested, addressed to the MIEMSS Office of Hospital Programs in Baltimore, Maryland. Requesting a hearing does not negate, or act as a stay of, the suspension or revocation. If the trauma or specialty referral center does not request a hearing in a timely manner, MIEMSS' notice of immediate suspension or revocation of designation is the final agency decision. Upon receipt of a hearing request, MIEMSS shall send a written request to OAH to schedule a hearing. OAH shall conduct the hearing within 10 business days of the date it receives the hearing request, except that the time period may be extended by: OAH for good cause; or Agreement of the trauma or specialty referral center and MIEMSS. Except as modified in this section, the hearing shall be conducted in accordance with the procedures set forth in §G of this regulation. Not later than 10 business days after the close of the hearing record, OAH shall issue a proposed decision that includes proposed findings of fact and conclusions of law and a proposed order, except that the time period may be extended by: OAH for good cause; or Agreement of the trauma or specialty referral center and MIEMSS. Appeal to the EMS Board. Filing of Exceptions. Not later than 5 business days from the date it receives the proposed decision, a party aggrieved by the proposed decision may appeal by filing written exceptions with the Executive Director, for consideration by the EMS Board. The exceptions shall state with specificity the reasons why the proposed decision should be overturned. A party filing exceptions may request an oral argument and shall submit the request with the exceptions. A party filing exceptions shall mail a copy of its exceptions to the opposing party by first class mail, postage prepaid. If exceptions are not filed within the specified time period, the OAH proposed decision is the final agency decision. Response to Exceptions. Not later than 5 business days after the opposing party receives a copy of the exceptions, the opposing party may file a response with the EMS Board. A party filing a response may request an oral argument and shall submit the request with the response. A party filing a response shall mail a copy of its response to the party filing exceptions by first class mail, postage prepaid. Decision of EMS Board. Not later than 30 calendar days after the filing of the exceptions or the response, whichever is later, the EMS Board shall issue a written decision granting or denying the exceptions. The EMS Board may, in its discretion, rule on the exceptions with or without oral argument. If the EMS Board denies the exceptions, the proposed decision, as affirmed by the EMS Board, is the final agency decision. If the EMS Board grants the exceptions, in whole or in part, the EMS Board shall modify the proposed decision accordingly and the modified decision is the final agency decision. The EMS Board shall issue its final decision in accordance with State Government Article, §§10-220 and 10- 221, Annotated Code of Maryland. A party aggrieved by a final agency decision may seek judicial review in accordance with State Government Article, §10-222, Annotated Code of Maryland, and the Maryland Rules of Civil Procedure. Hearing Procedures. A hearing shall be conducted in accordance with the procedures and regulations of OAH set forth in COMAR 28.02.01, except as modified by this regulation. Confidential Materials Not Discoverable. In addition to the restrictions on discovery of documents under COMAR 28.02.01.10, a party is not entitled to discovery of any confidential: Record; File; Memorandum; Correspondence; Document; Object; or Other tangible thing. For purposes of this regulation, all records, files, memoranda, correspondence, documents, objects, other tangible things, notes, minutes of conferences, and any other communications of members of an on-site review team are confidential. This subsection does not restrict the rights of: MIEMSS to obtain any information to which it is entitled under this subtitle; and A hospital to information originating from the hospital's files. In a proceeding before an administrative law judge or a court: MIEMSS may disclose information or present evidence that contains or might reveal confidential information if the information is relevant to the case; and If there is an objection, before the information is disclosed, the administrative law judge or court that is conducting the proceeding shall determine whether the information is confidential and, if it is, enter an order that it determines is appropriate to protect the confidentiality of the information. MIEMSS has the burden of proving, by a preponderance of the evidence, the grounds for suspension, revocation, lowered level of designation, or probation. Except for an emergency suspension or revocation under §F of this regulation, not later than 60 business days after the close of the hearing, OAH shall issue a proposed decision that shall include proposed findings of fact and conclusions of law and a proposed order. Appeal to the EMS Board. This section does not apply to an emergency revocation or suspension under §F of this regulation. Filing of Exceptions. Not later than 15 business days from the date it receives the proposed decision, a party aggrieved by the proposed decision may appeal by filing written exceptions with the Executive Director, for consideration by the EMS Board. The exceptions shall state with specificity the reasons why the proposed decision should be overturned. A party filing exceptions may request an oral argument and shall submit the request with the exceptions. A party filing exceptions shall mail a copy of its exceptions to the opposing party by first class mail, postage prepaid. If exceptions are not filed within the specified time period, the proposed decision is the final agency decision. Response to Exceptions. Not later than 15 business days from the date of the filing of the exceptions with the EMS Board, the opposing party may file a response with the EMS Board. A party filing a response may request an oral argument and shall submit the request with the response. A party filing a response shall mail a copy of its response to the party filing exceptions by first class mail, postage prepaid. Decision of EMS Board. The EMS Board may, in its discretion, rule on the exceptions with or without oral argument. If the EMS Board denies the exceptions, in whole or in part, the proposed decision is the final agency decision. If the EMS Board grants the exceptions, the EMS Board shall modify the proposed decision accordingly and the modified decision is the final agency decision. The EMS Board shall issue its final decision in accordance with State Government Article, §§10-220 and 10- 221, Annotated Code of Maryland. A party aggrieved by a final agency decision of the EMS Board may seek judicial review in accordance with State Government Article, §10-222, Annotated Code of Maryland, and the Maryland Rules of Civil Procedure. Education Article, §13-509, Annotated Code of Maryland Effective date: March 24, 1997 (24:6 Md. R. 488) Regulations .01—.06 amended effective July 1, 2002 (29:12 Md. R. 934) Regulation .03C, D amended effective December 19, 2005 (32:25 Md. R. 1947); October 12, 2015 (42:20 Md. R. 1265) In this chapter, the following terms have the meanings indicated. Terms Defined. “Accreditation Council for Graduate Medical Education (ACGME)” means the private, nonprofit council that evaluates and accredits medical residency programs in the United States. “Commission on Accreditation of Rehabilitation Facilities (CARF)” means the international independent, nonprofit accreditor of human service providers in the areas of rehabilitation, employment, child, and family. “Hand and upper extremity physician trauma team” means the physician team required by Regulation .03 of this chapter. “Hand Therapy Certification Commission (HTCC)” means an independent, nonprofit accrediting body for the testing and credentialing of hand therapists. A hand and upper extremity trauma center shall: Be licensed as an acute care hospital by the hospital licensing authority in the jurisdiction in which it is located; Be accredited by [the Joint Commission on Accreditation of Health Care Organizations] 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, with a designated hand surgery service; Have an emergency department which offers comprehensive emergency care 24 hours a day with: At least one physician experienced in emergency care on duty in the emergency care area; and In-hospital physician coverage by members of the medical staff or by senior-level residents who are postgraduate year 3 or higher for the following services: Medical; Surgical; Orthopedic; and Anesthesia; Have a resolution adopted by the Board of Directors of the hospital committing the hospital to: Participate in State and regional emergency medical services; and Maintain the infrastructure necessary to support the hospital's provision of state-of-the-art hand and upper extremity trauma care including the following resources necessary to the provision of such service: Financial; Human; and Physical. The hand and upper extremity trauma center shall have: A medical director; Appropriately educated nurse leaders and clinical staff to provide care for hand and upper extremity trauma patients; A fellowship training program in hand surgery accredited by the ACGME; A comprehensive post-trauma rehabilitation program accredited by CARF; A quality improvement program which participates in State and regional emergency medical services quality management; An educational program for physicians, nurses, and therapists who treat trauma patients with single system upper extremity trauma; A policy committee that oversees the activities of the hand and upper extremity trauma center; An internal morbidity and mortality conference scheduled to meet at least monthly to record and discuss any complications; A maintained hand registry; and Timely submission of data to the MIEMSS State trauma registry. The hospital shall have a hand and upper extremity physician trauma team that shall include at least eight physicians who are Board-eligible or Board-certified in the following specialties: General surgery; Plastic surgery; or Orthopedic surgery. A member of the hand and upper extremity physician trauma team shall be on call 24 hours a day with a response time of 30 minutes or less. As back-up, a second member of the hand and upper extremity physician trauma team shall be on call 24 hours a day with a response time of 30 minutes or less. The physicians who satisfy §A of this regulation shall also hold or be eligible to hold a Certificate of Added Qualifications in Hand Surgery through: The American Board of Orthopedic Surgery; The American Board of Plastic Surgery; or The American Board of Surgery. Each member of the hand and upper extremity trauma physician trauma team shall be competent in: Microsurgery of the upper extremity; Neurovascular surgery of the upper extremity; Emergency skeletal reconstruction; Emergency soft tissue reconstruction; and Upper limb replantation. A call roster for the hand and upper extremity physician trauma team shall be published and available in the emergency department and operating room. The hospital shall staff the hand and upper extremity trauma center with registered nurses competent in the care of patients with hand and upper extremity disorders. The hospital shall provide all nurses who care for patients in the hand and upper extremity trauma center with: Specific orientation to procedures and protocols for hand and upper extremity emergencies; and Education in hand and upper extremity emergencies and trauma care that meets the learning outcomes approved by MIEMSS. Nursing staff caring for hand and upper extremity trauma patients shall at a minimum have 8 hours of continuing medical education in hand trauma related topics every 2 years. Hand and upper extremity trauma facilities shall be able to optimally and comprehensively care for every patient with an isolated upper extremity injury from the time the patient arrives at the hospital through acute treatment, rehabilitation, reconstruction, and re-entry into the work force. Hand and upper extremity trauma area facilities shall have: A suite of rooms identified and specialized for examination and treatment of hand and upper extremity trauma emergencies in the hospital's emergency department with: A medical director or representative on the hospital's emergency services committee that shall oversee the management of the hand and upper extremity trauma center; and Appropriate nurse leaders who shall be responsible for all venues in which hand and upper extremity trauma care is rendered; Organized and specialized equipment and supplies to care for hand and upper extremity trauma including specialized prepackaged sterile surgical sets located in the hand trauma rooms to enable the performance of procedures including, but not limited to: Exploration and debridement of complex hand injuries; Bony debridement and shortening; Thermal injury care; Tendon repair; Full and partial thickness skin grafts; Composite tissue grafts; and Repair of simple and complex skin lacerations; Pneumatic tourniquets; High intensity light; Surgical loupes; Power equipment for skeletal fixation; Figure traps for fracture reduction; Casting material in a variety of sizes and compositions; Metallic malleable splints; Plastic or prefabricated splits; Specialized dressings for hand injuries including burns; Local anesthetics; and Doppler unit for vascular assessment. The hospital shall have appropriate staffing and equipment readily available to offer the following services to patients in the hand and upper extremity trauma area: Standard stationary radiography; Portable C-Arm fluoroscopy; Diagnostic vascular imaging; Interventional vascular procedures; CT and MRI scans; MR angiography; Radionuclide scanning; and Ultrasonography. The hospital shall have a direct communication link to the State communication network including: SYSCOM; Prehospital providers; and Referring hospitals. The hospital shall have pharmacy support to provide all needed medications 24 hours a day. The hand and upper extremity trauma center operating room shall have: Equipment for the treatment of all hand and upper extremity injuries reconstructive procedures; A specially trained and dedicated operating room team for hand surgery, musculoskeletal care, or both; Continuous availability of the operating suite with an in-house operating room scrub team 24 hours a day; and Specialized equipment readily available to enable: Microvascular tissue replantation; Microvascular free tissue transfer; Microsurgical nerve repair; Internal and external fixation of all bones of the upper extremity; Intraoperative vascular evaluation; Upper extremity endoscopy; and Upper extremity arthroscopy. The hand and upper extremity trauma center inpatient unit shall have a nursing unit for the care of the patient with upper extremity injuries that provides nursing staff who are: Specially educated and demonstrate competencies in the postoperative evaluation of limb replantation and revascularization; Able to independently monitor the tissue perfusion of replanted limbs; and Specially educated in the care and postoperative monitoring of free tissue transfers. The hand and upper extremity trauma center hand therapy unit shall have: A specialized area for inpatient and outpatient care utilizing individualized occupational and physical therapy techniques directed specifically towards the rehabilitation of the upper extremity; Certified and licensed occupational and physical therapists; Staff designated or qualified to be designated as certified hand therapist by the “Hand Therapy Certification Commission”; Regular educational programs presented by the therapy staff; A facility for the fabrication of custom individualized splints; and The ability to care for the following types of clinical problems: Flexor tendon repair and reconstruction; Extensor tendon repair and reconstruction; Nerve repair or reconstruction; Tendon transfers; Thermal injuries; Repetitive stress and cumulative trauma disorders; Training in the use of prosthetic devices; and Upper extremity replantation. The hand and upper extremity trauma center work rehabilitation services shall have: A CARF-accredited area dedicated to facilitating the transition of the injured worker back into the workforce; Equipment to stimulate and practice the activities required at the majority of work sites; Computerized analysis of multiple physical parameters required for performance in the workplace; The ability to evaluate ergonomic factors in the scenario of the workers' stations; and Social services to aid in the transition of the injured worker back into the workplace. The hand and upper extremity trauma center outpatient clinical area shall have: A dedicated adaptation hand clinic area for the evaluation and treatment of hand and upper extremity trauma patients on a nonemergent basis; and A hand and upper extremity medical staff physician responsible for the overall clinical coordination and care delivery. The hand and upper extremity trauma center microvascular laboratory shall have: A facility to practice the microsurgical techniques needed in the acute treatment and reconstruction of upper extremity trauma victims; Animal surgery available to simulate the human situation; and Individualized instruction in microsurgery. The hand and upper extremity trauma center anatomy laboratory shall: Have a facility for the dissection of human and animal specimens; and Facilitate instruction in pertinent anatomy implicit in the treatment of hand and upper extremity trauma victims. The hand and upper extremity trauma center information support services shall: Provide educational support services including: Preparation and dissemination of hand and upper extremity trauma educational information for: Patients; Providers; and The public; An Internet server for disseminating information regarding patient education and public safety; Audiovisual facilities to produce materials for presentations and patient education; and A robust conference schedule with rotating didactic lectureships covering the germinal information in the field of hand and upper extremity surgery; Provide psychosocial support, including a certified psychologist and a licensed social worker with special expertise in the evaluation and treatment of hand and upper extremity trauma victims; and Provide an amputee-prosthetic clinic as a regional resource for amputee prosthetics using a team approach for management of post trauma patients with hand or upper extremity amputations, which team shall include one or more of each of the following: Prosthetist; Social worker; Hand therapist; Hand resident; Hand fellow; and Attending hand surgeon. The hand and upper extremity trauma center shall have an ongoing quality management program integrated with the hospital's overall quality management system. Quality management for the hand and upper extremity trauma center shall include: Maintaining the hand physician representative on the following hospital committees to discuss quality management issues during monthly meetings: The hospital operating room committee; and The hospital emergency room committee; Attendance by the hand and upper extremity trauma center representative responsible for quality management and quality improvement activities at: The hand policy committee meetings; and The monthly hospital quality management meetings; Participation in State emergency medical services quality management activities; Maintenance of a hand and upper extremity trauma registry on patients admitted to the hand and upper extremity trauma center; Monthly review of hand and upper extremity trauma registry data and reports; Maintenance of a patient care database on patients treated through the hand and upper extremity trauma rehabilitation unit and evaluation of the various outcomes, measures, and protocols; Monthly review of morbidity and mortality data from the hand and upper extremity trauma center weekly patient sessions for trainees in which cases and complications can be discussed; Making available to MIEMSS documentation of quality management including: Problem identification; Analysis; Action plan; Implementation; and Reevaluation; and A monthly ethics in medicine forum to discuss ethical considerations that confront today's physician. The hand and upper extremity trauma center shall provide leadership and coordination for the development and implementation of prevention and public education programs for hand and upper extremity injuries, by, among other activities: Participation in MIEMSS outcome studies when requested; Training and teaching emergency medical services personnel; Serving as a public resource for the prevention and safety of hand and upper extremity injuries; Participation in media public service announcements for seasonal hand and upper extremity injuries; and Monitoring the progress of prevention programs in cooperation with State monitoring programs. The hand and upper extremity trauma center shall participate in an organized clinical research program which shall include: A research committee; and A research director who shall: Coordinate ongoing research projects; Meet monthly with hand and upper extremity trauma injury center staff to discuss the progress of research projects; Assist in the preparation of projects for presentation and publication; and Prepare documentation of ongoing research grants. Education of the hand and upper extremity trauma center medical staff shall include: Formal didactic lectures available weekly to all hand and upper extremity trauma center staff; At least every other week, cadaver prosections and dissections at the Maryland State Anatomy Board performed on various areas of the upper extremity performed by: Residents; Fellows; and Attending physicians; An annual course for free tissue transfer and brachial plexus dissections at the Maryland State Anatomy Board; The availability of cadaver specimens to evaluate and practice new surgical techniques and procedures for upcoming clinical cases; and An ACGME accredited fellowship program. Internal Continuing Education. Medical staff internal continuing education shall consist of: Participation in weekly case management conferences; Participation in weekly lecture series; Attendance at monthly specialized conferences that include the following subject areas: Amputee; Microsurgery; Plastic surgery; Congenital deformities; and Anatomy; Participation in monthly hand surgery journal club; Attendance at yearly visiting professor lecture and anatomy laboratory; Access to electronic educational materials in the specialty; Access to video library including: Hand surgery; and Microsurgery topics; and Completion of microsurgery laboratory refresher course. Operating room and inpatient nursing staff internal continuing education shall consist of: Participation in nurse specialty education opportunities and American Society for Surgery of the Hand meetings; Attendance at lectures by attending hand surgeons; Access to hand and upper extremity trauma center lecture series; Access to hand surgery and hospital library services; and Participation in case presentations and discussions as appropriate; Hand therapist internal continuing education shall consist of: Access to full schedule of hand center lecture series; Access to monthly congenital conference; Access to monthly hand surgery journal club; and Attendance at National Hand Therapy and American Society for Surgery of the Hand meetings. Special Training in Trauma Protocols. Training in trauma protocols shall include: Review of the new attending and house staff manual; Completion of an orientation/training session for new: Physicians; Nurses; and Therapists; and Review of trauma registry data including: Inclusion criteria; Definitions; and Reports. External Continuing Education. External continuing education programs concerning the care and treatment of hand and upper extremity trauma injury including attendance at external symposia and lectures are required. A hand and upper extremity trauma center shall maintain written policies and protocols for: Emergency triage and protocol for massive upper extremity injuries and replantation; Preoperative and postoperative orders for replantations and free flaps; Care and treatment of a upper extremity injuries; The physician on-call schedule for the hand and upper extremity trauma center; The interhospital transfer protocol; House staff privileges for: Educational activities; Responsibilities; and Grievances; The scope of care for the hand and upper extremity trauma center; and Extramural hospital house staff program agreements for rotation in the hand and upper extremity trauma center. Education Article, §13-509, Annotated Code of Maryland Effective date: August 13, 2007 (34:16 Md. R. 1433) Regulation .02A amended effective July 21, 2025 (52:14 Md. R. 714) In this chapter, the following term has the meaning indicated. Term Defined. “Freestanding emergency medical facility” means a facility licensed by the Maryland Department of Health under Health-General Article, §19-3A-02, Annotated Code of Maryland. Freestanding Emergency Medical Facility. A freestanding emergency medical facility: Shall be licensed under Health-General Article, §19-3A-02, Annotated Code of Maryland; Shall comply with COMAR 10.07.08; Shall abide by the protocols approved by the EMS Board for the transport by EMS of patients to freestanding emergency departments; Shall abide by the Maryland Emergency Medical Services Interfacility Transfer Guidelines published by MIEMSS; Shall participate in the County Hospital Alert Tracking System (CHATS) program; Shall have radios and the ability to communicate with EMS and base stations; Shall advise MIEMSS immediately of any change in status regarding the freestanding emergency department; and Shall participate in data collection and quality management as required in COMAR 30.08.04. MIEMSS shall designate a freestanding emergency medical facility that meets these requirements in accordance with COMAR 30.08.02. Notwithstanding COMAR 30.08.02.06, MIEMSS may designate a freestanding emergency medical facility licensed by the Maryland Department of Health under Health-General Article, §19-3A-02, Annotated Code of Maryland, without conducting an on-site review. The EMS Board shall consider the following factors in determining whether the conversion of a general hospital to a freestanding medical facility under COMAR 10.24.19.04C will maintain adequate and appropriate delivery of emergency care within the Statewide emergency medical services system: The EMS resources in the jurisdictions affected by the proposed hospital conversion, including staffing, equipment, and units; Any additional resources which will be provided by the hospital seeking to convert to augment the resources available in the affected jurisdiction. The EMS call volume of affected jurisdictions by priority; The projected number of patients who could require transport to a general acute hospital rather than the proposed freestanding medical facility for appropriate medical care; EMS transport times in the jurisdictions affected by the proposed hospital conversion and the potential for extended transport and out-of-service times resulting from the proposed conversion to a freestanding medical facility, relative to the current pattern of transport times; Commercial ambulance services availability and response times in the jurisdictions affected by the proposed hospital conversion; The number of general hospitals likely to be affected by the proposed hospital conversion and the distance to the closest general hospital ED for appropriate patients if the hospital converts to a freestanding medical facility relative to current patterns of hospital use; The expected additional ED visit volume and associated increases in admission and observation patient volumes for the general hospitals likely to be affected by the proposed hospital conversion; Recent diversion utilization at the converting hospital and other general hospitals likely to be affected by the proposed hospital conversion and the potential impact of the proposed conversion on diversion utilization; The size, scope, configuration, services, and staffing of the proposed project; and Reasonable changes in the EMS system that are planned or can be made to maintain adequate and appropriate delivery of emergency care within the Statewide emergency medical services system if the hospital converts to a freestanding medical facility. A general hospital seeking an exemption from a certificate of need to convert to a freestanding medical facility shall: Notify MIEMSS in writing of its intent to seek an exemption at least 14 days prior to a public informational hearing required by the Maryland Health Care Commission; Notify and seek input from EMS providers in jurisdictions affected by the proposed conversion at least 14 days prior to a public informational hearing required by the Maryland Health Care Commission, by publishing a physical address and email address on its website for receipt of comments; Provide to MIEMSS the information required in COMAR 10.24.19C(8)(a),(b), (d), (e),(i), and (j) to MIEMSS within 7 days of the public informational hearing required by Maryland Health Care Commission regulations; and Submit all notices and information required pursuant to COMAR 10.24.19.04(C) simultaneously to both the Maryland Health Care Commission and MIEMSS. MIEMSS will continue to accept direct input from stakeholders for a period of 10 business days following the public informational hearing. MIEMSS will provide any direct input from stakeholders to the hospital proposing the conversion and allow the hospital 5 business days to respond. The EMS Board will issue the determination concerning the proposed hospital conversion under §A of this regulation within 45 days of the required public informational hearing held by the hospital proposing the conversion, in consultation with the Maryland Health Care Commission. MIEMSS will provide a copy of any determination issued by the EMS Board under this regulation to the Maryland Health Care Commission upon its issuance. Education Article, §13-509; Health-General Article, §19-120(o)(3); Annotated Code of Maryland Effective date: May 5, 2008 (35:9 Md. R. 900) Regulation .02A amended effective December 12, 2013 (40:24 Md. R. 2018) Regulation .03 adopted effective July 31, 2017 (44:15 Md. R. 761) In this chapter, the following terms have the meanings indicated. Terms Defined. “Cardiac Interventional Center” means: An in-State hospital that meets the requirements in Regulation .02 of this chapter and is designated by MIEMSS and approved by the EMS Board to receive patients transported by ambulance with acute ST-segment elevation myocardial infarction (STEMI) who need Primary Percutaneous Coronary Intervention; or An out-of-State hospital that has entered into an agreement with MIEMSS and has been approved by the EMS Board to receive patients with acute ST-segment elevation myocardial infarction who need Primary Percutaneous Coronary Intervention. “Jurisdiction” means a state, commonwealth, or the District of Columbia. “Percutaneous coronary intervention (PCI)” means a variety of catheter-based techniques, including balloon angioplasty, capable of relieving coronary vessel narrowing. “Primary PCI” means PCI capable of relieving coronary vessel narrowing associated with acute ST-segment elevation myocardial infarction (STEMI). “STEMI” means coronary vessel narrowing associated with ST-segment elevation myocardial infarction. A Cardiac Interventional Center shall be licensed as an acute care hospital by the hospital licensing authority in the jurisdiction in which it is located. If located in Maryland, a Cardiac Interventional Center shall: Have one of the following: A Certificate of Need (CON) issued by the Maryland Health Care Commission for a cardiac surgery and percutaneous coronary intervention (PCI) program; or A current waiver issued by the Maryland Health Care Commission to provide primary percutaneous coronary intervention (PCI) services to STEMI patients meeting certain criteria without on-site cardiac surgery; and Be a base station approved under COMAR 30.03.06. If not located in Maryland, a Cardiac Interventional Center shall: Possess all government approvals required to provide Primary PCI under the laws of the jurisdiction in which it is located including, if required, a CON; and Satisfy one of the following: Be a base station approved under COMAR 30.03.06; or Have the equipment necessary to conduct a dual consult between EMS and a Maryland base station for each Maryland patient transported to the Cardiac Interventional Center. A Cardiac Interventional Center shall: Provide primary PCI as soon as possible and not to exceed 90 minutes from patient arrival, that is, door to balloon time of less than 90 minutes, for 75% of appropriate STEMI patients; Provide primary PCI for appropriate STEMI patients 24 hours per day, 7 day per week; Have adequate physician, nursing, and technical staff to provide cardiac catheterization and coronary care unit services 24 hours per day, 7 days per week; Have a single call access system for receiving patients with STEMI; Participate in the County Hospital Alert Tracking System (CHATS) program; Abide by the Maryland Emergency Medical Services Inter-Hospital Transfer Guidelines published by MIEMSS in addition to any applicable transfer requirements in COMAR 10.24.17; Communicate as soon as possible with the STEMI patient's primary physician and cardiologist regarding patient outcome; Establish a Cardiac Interventional Center medical review committee which shall be a medical review committee under Health Occupations Article, §1-401, Annotated Code of Maryland, as a committee established in the Maryland Institute for Emergency Medical Services Systems which: Meets at least three times a year; Reviews practice patterns; and Modifies practice patterns as appropriate; and Comply with the requirements of COMAR 30.08.04, including participating in: A Cardiovascular Data registry jointly approved by MHCC and MIEMSS, including any registry data reporting requirements established by either MIEMSS or MHCC; and State specialty care quality management activities of MIEMSS or of MHCC that are approved by MIEMSS. A Cardiac Interventional Center may receive STEMI patients transported by ambulance directly to the catheterization lab when approved by the base station physician if the catheterization lab has a physician, appropriately credentialed to evaluate and stabilize an acute cardiac patient, a registered nurse, and a technician, capable of activating the catheterization lab, immediately available in house when: The 12 lead EKG in the field is interpreted by an advanced life support EMS provider as a high probability of a STEMI; or The 12 lead EKG in the field has been reviewed by an ED physician, a cardiologist, or both, and determined to be a STEMI. Notwithstanding COMAR 30.08.02.06, MIEMSS may designate any Cardiac Interventional Center without a site review. Notwithstanding §A of this regulation, MIEMSS staff may conduct an onsite review to verify compliance with this chapter, including: Inspecting the hospital's physical plant; Interviewing team members and management personnel; Examining the hospital's Cardiac Interventional Center related documents, including patient care records; and Reviewing other materials considered appropriate by MIEMSS. The Maryland Health Care Commission staff may participate in any review conducted by MIEMSS to verify compliance with COMAR 30.08.15, including reviewing application materials, and participating in any on-site review. MIEMSS staff may participate in any review conducted by the Maryland Health Care Commission to verify compliance with COMAR 10.24.17, including reviewing application materials, and participating in any on-site visits. Education Article, §13-509, Annotated Code of Maryland Effective date: May 3, 2010 (37:9 Md. R. 674) In addition to meeting the requirements of COMAR 30.08.11.01, a designated comprehensive stroke center hospital shall: Be designated by MIEMSS as a primary stroke center at the time of application for designation as a comprehensive stroke center; Continue to meet the primary stroke center requirements in COMAR 30.08.11 to the extent such requirements are consistent with designation as a comprehensive stroke center; Act as a resource center for other facilities in its region or state; Annually care for at least 20 Subarachnoid Hemorrhage by aneurysm patients per year; Annually perform a combined total of 15 endovascular coiling and surgical clippings per year for aneurysm; Annually administer fibrinolytics to 25 eligible patients per year or 50 eligible patients over 2 years: IV fibrinolytic ordered and monitored via telemedicine at another hospital is acceptable; and IV fibrinolytic administered at an outside hospital and transferred to CSC site is acceptable; Satisfy the MIEMSS requirements for designation as a comprehensive stroke center by MIEMSS; and Meet the requirements for a site review in COMAR 30.08.02.06, which may be satisfied by completing either: An on-site review by MIEMSS; or A site survey as part of The Joint Commission Disease Specific Care Certification Program for certification as a comprehensive stroke center if the hospital: Authorized The Joint Commission to provide MIEMSS with survey findings, certification reports, and other information related to The Joint Commission's certification of the hospital as a comprehensive stroke center; Allows MIEMSS to participate in the accreditation site survey; and Provides MIEMSS any additional information required to determine it has satisfied the requirements for designation under this chapter. The designated comprehensive stroke center shall meet the requirements of COMAR 30.08.11.02. The designated comprehensive stroke center shall meet the requirements of COMAR 30.08.11.03. The designated comprehensive stroke center shall maintain a dedicated neuroscience intensive care unit that meets the requirements of this regulation and: Has designated beds for the care of acute stroke patients; Has 24/7 on-site practitioners with neurovascular training, including, for example, APNs, PAs, neuro-intensivists, fellows, or residents; Provides care to acute stroke patients through qualified clinical staff who meet the requirements in Regulations .12—.15 of this chapter; Follows standardized processes derived from evidence-based practice clinical practice guidelines to facilitate clinical care; Incorporates individualized plans of care that are based on the patient’s assessed needs and reflect coordination of care with other programs, as determined by patient comorbidities; Has a process to assess the abilities and resources of family members to be involved in post-acute care; and Maintains written documentation delineating the function of the neuroscience intensive care unit, including: Admission criteria; Discharge criteria; Acute stroke care protocols; Interdisciplinary rounding; Rehabilitation assessment and services in the hospital; and Outcome data. In addition to meeting the requirements of COMAR 30.08.11.07, the designated comprehensive stroke center shall: Have sufficient personnel available to respond to health care personnel at other hospitals to provide them with guidance and recommendations about the diagnosis and treatment of stroke and referral to an appropriate facility if transfer is required or requested; Have written policies or procedures to direct the organized, safe, intra-hospital and inter-hospital transport of stroke patients; Have priority bed availability for stroke patients with appropriately trained registered nurses in sufficient numbers based on patient acuity; and Have a written plan for triaging patients from the neuroscience intensive care unit and/or the dedicated this unit to make beds available for other stroke patients when necessary or for provision of alternate critical care beds for stroke patients with appropriately trained registered nurse staff. In addition to meeting the requirement of COMAR 30.08.11.05, the hospital shall: Establish one or more acute stroke teams which shall respond to the emergency department with coordinated services for the effective delivery of emergency and acute stroke treatment; Use the National Institutes of Health Stroke Scale (NIHSS) for the initial assessment of patients with acute stroke, with clinicians performing an NIHSS having documented training in the completion of the NIHSS; and Perform ongoing neurological assessment on patients with acute stroke. The acute stroke team shall include at a minimum: A physician, with special competence in caring for the acute stroke patient, who is Board-certified or Board-eligible in: Neurology; Critical care medicine; or Emergency medicine; and At least one additional health care provider, with experience in caring for the acute stroke patient, who may be: An emergency physician; A neurology resident or fellow; An internist; A registered nurse; A physician assistant; or A nurse practitioner. If a physician otherwise satisfies §B(1) of this regulation but is not Board-certified or Board-eligible in neurology, a Board-certified or Board-eligible neurologist shall be available within 15 minutes for consultation under the terms of a written agreement by: Telephone; or Audio/visual communication. In addition to meeting the requirements of COMAR 30.08.11.04, the hospital shall have: An attending board certified/board eligible neurosurgeon on call with a 45-minute arrival time to the hospital; Written procedures demonstrating the ability to care for two complex neurosurgical stroke patients at one time using appropriate clinical staff; and Written documentation demonstrating on-call and back-up on-call schedules for physicians and staff for 24/7 coverage. The hospital shall have: Interventional services promptly available 24 hours a day with appropriately trained support staff and equipment, including: Intra-arterial reperfusion therapy; Endovascular treatment of vasospasm; Endovascular ablation of arterial venous malformations; Stenting/angioplasty of extracranial vessels; and Stenting/angioplasty of intracranial vessels; A neurointerventionalist who may be a board-certified/board-eligible neuroradiologist, neurologist, or neurosurgeon on call with a 45-minute arrival time to the hospital; An on-call schedule for primary and back-up neurointerventionalists or neuroradiologists; A written protocol to accept the inter-facility transfer of acute ischemic stroke patients requiring endovascular therapy that includes communication and feedback to the sending facility; and A written protocol to accept the inter-facility transfer of acute stroke patients requiring a higher level of care. In addition to meeting the requirements of COMAR 30.08.11.09, a designated comprehensive stroke center shall have the following diagnostic capability available when indicated: Carotid duplex ultrasound; Transcranial ultrasonography; and Transesophageal or transthorasic echocardiogram. The hospital shall meet the requirements of COMAR 30.08.11.08. Director. The stroke center medical director shall be a physician with competence in caring for the acute stroke patient and be Board-certified or Board-eligible in: Neurology; Neurosurgery; or Vascular neurology. The stroke center medical director’s qualifications shall include: Completion of a stroke fellowship or vascular neurosurgery fellowship and obtained vascular neurology certification by the American Board of Psychiatry and Neurology; Active participation in the Stroke Quality Improvement Council (QIC); 12 hours of category 1 CME credits related to stroke care annually; Participation in at least one regional, national, or international stroke conference annually; Participation in stroke patient morbidity and mortality reviews; and Participation in stroke research and publication efforts. Neurologists, Neurosurgeons, NeurInterventionalists, NeuroRadiologisst, NeuroIntensivists, and Vascular Surgeons. Qualifications for neurologists, neurosurgeons, neurointerventionalists, neuroradiologists, vascular surgeons and neurointensivists shall include: Board certification or Board eligibility in their specialty as approved by the American Board of Medical Specialties; Completion of: A fellowship; Demonstrated experience equivalent to completion of a stroke specialty fellowship appropriate to their area of expertise; or Both of these; 8 or more hours of category 1 or 2 CME credits per year related to stroke care; Participation in stroke patient morbidity and mortality reviews; and Participation in stroke research and publication efforts. Emergency Physicians. The qualifications of emergency physicians who care for stroke patients shall include: Board certification or Board eligibility in emergency medicine as approved by the American Board of Medical Specialties; Participation in stroke patient morbidity and mortality reviews; 4 or more hours of category 1 or 2 CME credits per year related to stroke care; and Participation in stroke research and publication efforts. Nurse Practitioners. Nurse Practitioners who care for stroke patients shall: Hold a current license with the Maryland State Board of Nursing to practice as a registered nurse; Maintain certification as a nurse practitioner from the American Nurses Credentialing Center or other certification organization as deemed appropriate by the Maryland State Board of Nursing; and Be credentialed through the hospital’s credentialing process. Physician Assistants. Physician assistants who care for stroke patients shall: Have graduated from a physician assistant educational program accredited by the Accreditation Review Commission on Education for the Physician Assistant or its successor; Maintain current certification by the National Commission on Certification of Physician Assistants; Maintain an approved delegation agreement on file with the Maryland Board of Physicians; and Be credentialed through the hospital credentialing process. Clinical nurses, nurse practitioners, and physician assistants providing care to stroke patients in the neuroscience intensive care unit shall be trained in assessment of neurological function and management and treatment of all aspects of neurocritical care, including: Function of ventriculostomy and external ventricular drainage apparatus; Monitoring and treatment of increased intracranial pressure; Care of patients with intracranial hemorrhage and subarachnoid hemorrhage; Care of patients post fibrinolytic therapy; Care of patients post mechanical thrombectomy; Treatment of blood pressure abnormalities with parenteral vasoactive agents; Management of intubated/ventilated patients; and Detailed neurological assessments and scales (i.e., National Institute of Health Stroke Scale and the Glasgow Coma Scale). Continuing education requirements for nurses, nurse practitioners, and physician assistants who care for the acute stroke patients in the neuroscience intensive care unit shall include at least 5 hours of stroke-specific education annually. Emergency department nurses, nurse practitioners, and physician assistants who triage patients in the emergency department or care for acute stroke patients shall be trained in: Assessment of acute stroke; Treatment of acute stroke; Use of clinically appropriate fibrinolytic in acute ischemic stroke and the indication for endovascular therapy in acute ischemic stroke; Mechanical thrombectomy protocols; Treatment of blood pressure abnormalities with parenteral vasoactive agents; Neurological assessments and scales (i.e., National Institute of Health Stroke Scale and the Glasgow Coma Scale); Management of intubated/ventilated patients; and Care of patients post fibrinolytic therapy. Continuing education requirements for nurses, nurse practitioners, and physician assistants who care for the acute stroke patients in the emergency department shall include at least 5 hours of stroke-specific education annually. Continuing education requirements for nurses, nurse practitioners and physician assistants who care for the acute stroke patients in the stroke unit shall include a minimum of 5 hours of stroke-specific education annually. The designated comprehensive stroke center shall meet the requirements of COMAR 30.08.11.12. In addition to meeting the requirements of COMAR 30.08.11.13, the hospital shall: Have written policies ensuring that: Transfer of patients from another facility is appropriate and patients are received in a timely manner; and All stroke patients receive care commensurate with the hospital’s designation as a comprehensive stroke center; Have written care protocols for advanced treatment of complex stroke patients, including, but not limited to, acute ischemic stroke patients, acute intra-arterial therapeutic interventions, management of intracranial hemorrhage, and management of subarachnoid hemorrhage; Have written procedures demonstrating the ability of neurosurgery and interventional radiology to care for two complex stroke patients at one time with appropriate clinicians; Maintain up-to-date written care protocols for the treatment of acute stroke in: The neuroscience intensive care unit; The stroke unit; The emergency department; and All other locations where stroke care is provided; Have established mechanisms to serve and act as a resource center for other facilities in their region or state, which shall include: Providing expertise in managing particular cases through the use of telemedicine or other alternative means; Offering guidance for triage of patients; Providing advanced diagnostic, surgical or interventional procedures and treatment to patients initially treated at a non-primary stroke center or a primary stroke center; and Acting as an educational resource for other hospitals and health care professionals; and Have written policies and or protocols delineating the scope of practice and the roles and responsibilities of nurse practitioners and physician assistants providing care to the acute stroke patient in the neuroscience intensive care unit, the emergency department, and the stroke unit. In addition to the requirements of COMAR 30.08.11.14, the hospital shall incorporate into the hospital’s quality assurance process reports about: Specific acute stroke treatment benchmarks; and Stroke treatment quality improvement goals. The hospital shall establish a multidisciplinary institutional quality assurance/performance improvement committee that meets on a regular basis to: Monitor quality benchmarks; Review complications; and Review and modify practice patterns as appropriate. In cases where mechanical endovascular reperfusion therapy is appropriate, the hospital shall achieve door-to-device times (arrival to first pass of thrombectomy device) in 50 percent or more of eligible acute ischemic stroke patients within 120 minutes (for direct arriving patients) and within 60 minutes (for inter-facility transfer patients) treated with endovascular therapy. The hospital shall demonstrate progress towards reducing door-to-device times in 50 percent or more of eligible acute ischemic stroke patients within 90 minutes for direct arriving patients. A hospital shall: Have an acute stroke research program and acute stroke research plan; and Demonstrate participation in clinical research trials in acute stroke care. Education Article, §13-509, Annotated Code of Maryland Effective date: October 17, 2011 (38:21 Md. R. 1280) Chapter revised effective January 1, 2022 (48:22 Md. R. 938) A designated acute stroke ready center shall: Be licensed as a hospital or freestanding medical center by the licensing authority in the jurisdiction in which it is located; If a hospital, 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; If located in Maryland, be a base station approved under COMAR 30.03.06; Provide assessment and management of the stroke patient consistent with the most current AHA/ASA consensus based clinical practice guidelines to meet the needs of the patient; Have a stroke center medical director; Have a stroke center nurse coordinator dedicated to the facility; Have sufficient personnel and resources needed to facilitate healthcare data management and concurrent review of quality metrics and program objectives; Meet the requirements of Regulations .02—.14 of this chapter; Satisfy the MIEMSS requirements for designation as an Acute Stroke Ready Center; and Meet the requirements for a site review in COMAR 30.08.02.06, which may be satisfied by completing either: An on-site review by MIEMSS; or A site survey as part of The Joint Commission Disease Specific Care Certification Program for certification as an acute stroke ready center if the facility: Authorizes The Joint Commission to provide MIEMSS with survey findings, certification reports, and other information related to The Joint Commission’s certification of the hospital as an acute stroke ready center; Allows MIEMSS to participate in the accreditation site survey; and Provides MIEMSS any additional information required to determine it has satisfied the requirements for designation under this chapter. The facility’s board of directors, administrators, and medical and nursing staff shall demonstrate commitment to the facility’s designation as an acute stroke ready center by: A board of directors’ resolution stating that the facility agrees to meet the standards of this chapter for designation as an acute stroke ready center; An organizational chart showing key stroke center personnel, including the stroke center medical director and the stroke center nurse coordinator and their relationship with the facility; Establishing mechanisms to guide and assure cooperative relationships with community and professional groups committed to increasing public awareness and improving acute stroke care; Maintaining documentation of stroke center leadership, including: An appointment letter for the stroke center medical director; and Curricula vitae of key stroke program personnel with training and expertise in cerebrovascular disease, including: Physicians; Stroke center nurse coordinator; and Other key health care personnel; and Maintaining bylaws, contracts, and budgets specific to acute stroke care, indicating the facility’s commitment to the financial, human, and physical resources necessary to support the facility’s designation as an acute stroke ready center. The facility shall maintain an emergency department which: Has written documentation on the process used to notify the stroke team of a patient with an acute stroke; and Has sufficient emergency department clinical staff to meet the requirements of COMAR 30.08.11.05. The facility shall have a written agreement with a hospital which has operating room neurosurgical services available 24 hours a day with appropriately trained support staff. Neurosurgical coverage shall be documented in a written plan approved by the covering neurosurgeon or neurosurgeons, stroke program leaders, and any involved facilities. Neurosurgical services shall be available to patients within 2 hours of it being deemed necessary. There shall be a written protocol for transfer that includes communication and feedback from the receiving facility. The facility shall establish one or more acute stroke teams which shall respond to the emergency department with coordinated services for the effective delivery of emergency and acute stroke treatment. The facility shall have the following present at the patient’s bedside: A member of the emergency department clinical staff shall evaluate each patient with stroke-like symptoms within 10 minutes of the patient’s arrival at the emergency department; and At least one member of the acute stroke team to provide care and to treat an acute stroke patient within 15 minutes of notification. The National Institutes of Health Stroke Scale (NIHSS) shall be used for the initial and serial assessment of patients with acute stroke. Clinicians performing the NIHSS will have documented training in the completion of the NIHSS. The acute stroke team shall include at a minimum: A physician with special competence in caring for the acute stroke patient who is Board certified or Board eligible in: Neurology; Emergency medicine; Family medicine; or Internal medicine; and At least one additional health care clinician with experience in caring for the acute stroke patient who may be: A family medicine physician; An internist; An emergency physician; A registered nurse; A physician assistant; or A nurse practitioner. If the physician who satisfies §C(1) of this regulation is not Board certified or Board eligible in neurology, a Board certified or Board eligible neurologist shall be available within 15 minutes for consultation under the terms of a written agreement by: Telephone; or Audio/visual communication. The facility shall: Transfer the clinically appropriate acute stroke patient after initial treatment and stabilization to the appropriate MIEMSS designated primary stroke center, primary stroke center with endovascular capability, or comprehensive stroke center; and Maintain an agreement or agreements with a commercial ambulance service to: Transfer stroke patients as clinically necessary; Ensure the appropriate delivery of care during transport; and Limit utilization of local emergency medical services (EMS) resources unless by pre-existing agreement. The facility shall: If an acute care hospital, maintain a stroke unit that meets the requirements of this regulation which: Has designated beds for the care of patients not eligible for fibrinolytic therapy or endovascular therapy through qualified clinical staff who meet the requirements in Regulation .10 of this chapter; Develops a standardized process originating in clinical practice guidelines or evidence-based practice to deliver or facilitate the delivery of clinical care; Develops an individualized plan of care that is based on the patient’s assessed needs and reflects coordination of care with other programs, as determined by patient comorbidities; and Maintains written documentation delineating the function of the stroke unit including: Admission criteria; Discharge criteria; Stroke care protocols; Patient census; Rehabilitation in the hospital; Rehabilitation after discharge; and Outcomes data; or If not an acute care hospital, have a written transfer agreement with a hospital which: Meets the requirements of this chapter; Has an inpatient stroke unit that meets the requirements of this regulation; and Can admit the patient after initial treatment and stabilization. The facility shall have the ability 24 hours a day to perform laboratory and diagnostic services within 45 minutes of written order, including but not limited to: Complete blood count; Blood chemistries; Coagulation studies; Troponin; Electrocardiograms; and Chest radiographs. The facility shall have the ability 24 hours a day within 20 minutes of the patient’s arrival to complete: All of the following: Brain computed tomography; CT Angiography; and CT Perfusion; or Magnetic resonance imaging. The facility shall have the ability 24 hours a day to have computed tomographic studies interpreted within 20 minutes of their completion by a physician experienced in interpreting computed tomographic studies. The facility shall have the ability 24 hours a day to have CT angiography, CT perfusion, and magnetic resonance imaging studies interpreted within 30 minutes of their completion by a physician experienced in interpreting CT angiography, CT perfusion, and magnetic resonance imaging studies. The acute stroke ready center shall: Have the ability to upload emergent imaging scans into CRISP (Chesapeake Regional Information System for our Patients) which will facilitate sharing of emergent imaging with the receiving center; and Have the imaging ability to rapidly identify core (nonviable) infarct versus (potentially salvageable) penumbra. The stroke center medical director shall be a physician with special competence in caring for the acute stroke patient who is clinically active at the facility and is Board certified or Board eligible in: Neurology; Internal medicine; or Emergency medicine. The stroke center medical director’s qualifications shall include active participation in the Stroke Quality Improvement Council (QIC) and 8 or more hours of category 1 CME credits related to stroke care annually. Qualifications for stroke center physicians who care for stroke patients shall include 4 or more hours of category 1 or 2 CME credits per year related to stroke care. Training for nonphysician stroke center professional staff who care for acute stroke patients shall include 4 or more hours of continuing medical education per year in the area of cerebrovascular disease. Emergency department clinical staff shall participate in cerebrovascular disease educational activities at least two times a year if they: Triage patients in the emergency department; or Care for acute stroke patients. Emergency department clinical staff who triage patients in the emergency department or care for acute stroke patients shall be trained in: Diagnosis of acute stroke; Treatment of acute stroke; and Use of clinically appropriate fibrinolytics and educated on the indication and referral for endovascular therapy in acute ischemic stroke. Surviving stroke patients and their families shall receive instruction on: Signs and symptoms of acute stroke, including the importance of activating EMS; Effects and prognosis of acute stroke; Potential complications of acute stroke; Needs and rationales for treatment; Patient compliance instructions for risk reduction of individual risk factors and secondary prevention programs; and Post-stroke support services. The facility shall support or participate in, or both support and participate in, acute stroke educational activities developed for EMS personnel which are conducted at least once a year. The facility shall develop and implement: A written policy which demonstrates that the facility has established the acute stroke ready center to: Monitor the care delivered to acute stroke patients; Improve the quality of care delivered to acute stroke patients; Move patients through the initial acute care phase of their hospital stay in a timely fashion; and Ensure that all stroke patients will receive medical care commensurate with the hospital designation as an acute stroke ready center; Written procedures for rapidly activating the stroke team to care for potentially eligible fibrinolytic and endovascular candidates within 15 minutes of notification; Written care protocols for the treatment of acute stroke which address: Evaluation of each patient by a member of the emergency department clinical staff within 10 minutes of the patient’s arrival at the hospital emergency department; At least one member of the stroke team arriving at the acute stroke patient’s bedside within 15 minutes of notification; Ischemic stroke; Hemorrhagic stroke; Stabilization of vital functions; Initial diagnostic tests; The use of medications including fibrinolytics; Care of the potential endovascular candidate; and Timely and safe patient transfer within 2 hours or less of emergency department arrival or when medically stable; A current agreement with a transport service to meet the timeline in §C(9) of this regulation; and A written protocol for transfer that includes communication and feedback from the receiving facility, which is: Updated at least annually; and Maintained up-to-date in: The emergency department; and All other locations where stroke care is provided. The facility shall: Participate, in a manner approved by the EMS Board, in a stroke registry that includes the data elements tracked by the Centers for Medicare and Medicaid Services and the American Heart/American Stroke Get With the Guidelines®-Stroke Registry; Have participated in the stroke registry and maintained a stroke log for a minimum of 6 months prior to time of requesting an application; Demonstrate ongoing participation in the stroke registry; Authorize the stroke registry to provide the hospital data to MIEMSS for health oversight activities in a manner approved by the EMS Board; Establish at least two outcome objectives that: Are time-specific; Are measurable; Reflect tracking and trending of performance measures and indicators; and Are reviewed in annual comparison studies; Maintain a stroke log which includes at a minimum the following information for each entry: The number of times the stroke team was activated; The stroke team’s response time to the acute stroke patient; The on-call neurologist’s response time for consultation to the acute stroke patient; The type or types of diagnostic tests and acute treatment utilized; The patient’s diagnosis; Door to IV fibrinolytic time; Patient complications; Arrival and departure/transfer times; and Disposition of the patient; Monitor its IV fibrinolytic complications, which includes symptomatic intracerebral hemorrhage and serious life-threatening systemic bleeding; Establish at least one stroke center quality assurance medical review committee which shall be a medical review committee under Health Occupations Article, §1-401, Annotated Code of Maryland, as a committee established in the Maryland Institute for Emergency Medical Services Systems which, at least three times a year: Meets; Reviews practice patterns; and Modifies practice patterns as appropriate; In cases where the administration of fibrinolytics is appropriate: Administer the fibrinolytic within 60 minutes from the time the patient arrives at the emergency department for greater than or equal to 50 percent of eligible patients; Demonstrate progress towards administering fibrinolytics within 60 minutes from the time the patient arrives at the emergency department for greater than or equal to 75 percent of eligible patients; and Demonstrate progress towards reducing time of administration of fibrinolytics to 45 minutes for greater than or equal to 50 percent of eligible patients; Incorporate into their quality assurance process progress reports about: Specific acute stroke treatment benchmarks; Outcomes data on patients transferred for a higher level of care; and Stroke treatment quality improvement goals; and Provide MIEMSS with documentation of quality management of the stroke program for review, including, if appropriate: Problem identification; Problem analysis; An action plan; Implementation of the plan; and Re-evaluation of the plan. Education Article, §13-509, Annotated Code of Maryland Effective date: July 1, 2021 (48:9 Md. R. 360) Regulation effective July 21, 2025 (52:14 Md. R. 714) In addition to meeting the requirements of COMAR 30.08.11, a designated thrombectomy-capable primary stroke center hospital shall: Be designated by MIEMSS as a primary stroke center at the time of application for designation as a thrombectomy-capable primary stroke center; Continue to meet the primary stroke center requirements in COMAR 30.08.11 to the extent such requirements are consistent with designation as a thrombectomy-capable primary stroke center; Require each physician who performs mechanical thrombectomy to have performed 15 mechanical thrombectomies over the past 12 months or 30 over the past 24 months, which may include procedures performed at other facilities; Perform mechanical thrombectomy and have provided post-procedure care for a minimum of 15 patients in the past 12 months or at least 30 patients over the past 24 months; Meet the requirements of Regulations .01—.15 of this chapter; Satisfy the MIEMSS requirements for designation as a thrombectomy-capable primary stroke center by MIEMSS; and Meet the requirements for a site review in COMAR 30.08.02.06, which may be satisfied by completing either: An on-site review by MIEMSS; or A site survey as part of The Joint Commission Disease Specific Care Certification Program for certification as a thrombectomy-capable primary stroke center if the hospital: Authorizes The Joint Commission to provide MIEMSS with survey findings, certification reports, and other information related to The Joint Commission’s certification of the hospital as a thrombectomy-capable primary stroke center; Allows MIEMSS to participate in the accreditation site survey; and Provides MIEMSS any additional information required to determine that the hospital has satisfied the requirements for designation under this chapter. A hospital designated as a thrombectomy-capable primary stroke center shall meet the requirements of COMAR 30.08.11.02. The emergency department of a hospital designated as a thrombectomy-capable primary stroke center shall meet the requirements of COMAR 30.08.11.03 The operating room of a hospital designated as a thrombectomy-capable primary stroke center shall meet the requirements of COMAR 30.08.11.04 In addition to meeting the requirements of COMAR 30.08.11.05, the acute stroke team shall include at a minimum: A physician, with special competence in caring for an acute stroke patient, who is Board-certified or Board-eligible in: Neurology; Critical care medicine; Emergency medicine; or Internal medicine; and At least one additional health care provider, with experience in caring for the acute stroke patient, who may be: An emergency physician; An internal medicine physician; A neurology resident or fellow; A registered nurse; A physician’s assistant; or A nurse practitioner. If a physician otherwise satisfies §A(1) of this regulation but is not Board-certified or Board-eligible in neurology, a Board-certified or Board-eligible neurologist shall be available within 15 minutes for consultation under the terms of a written agreement by: Telephone; or Audio/visual communication. A hospital designated as a thrombectomy-capable primary stroke center shall maintain an intensive care unit that: Has designated beds for the care of the acute stroke patient; Has 24/7 on-site practitioners with critical care privileges, including, for example, APNs, PAs, fellows, or residents; Provides care to acute stroke patients through qualified clinical staff who meet the requirements in Regulation .11 of this chapter; Follows standardized processes derived from evidence-based clinical practice guidelines to facilitate clinical care; Incorporates individualized plans of care that are based on the patient’s assessed needs and reflect coordination of care with other programs, as determined by patient comorbidities; Has a process to assess the abilities and resources of family members to be involved in post-acute care; and Maintains written documentation delineating the function of the intensive care unit, including: Admission criteria; Discharge criteria; Acute stroke care protocols; Interdisciplinary rounding; Rehabilitation assessment and services in the hospital; and Outcome data. The stroke unit of a hospital designated as a thrombectomy-capable primary stroke center shall meet the requirements of COMAR 30.08.11.07. A hospital designated as a thrombectomy-capable primary stroke center shall meet the requirements of COMAR 30.08.11.08. In addition to meeting the requirements of COMAR 30.08.11.09, a hospital designated as a thrombectomy-capable primary stroke center shall have the following diagnostic capability available when indicated: Carotid duplex ultrasound; Transcranial ultrasonography; and Transesophageal/transthoracic echocardiogram. A hospital designated as a thrombectomy-capable primary stroke center shall have: Interventional services promptly available 24 hours a day with appropriately trained support staff and necessary equipment; Interventional services that include: Intra-arterial reperfusion therapy; and Stenting/angioplasty of intracranial vessels; A neurointerventionalist who may be a Board-certified/Board-eligible neuroradiologist, neurologist, or neurosurgeon on-call with a 45-minute arrival time to the hospital; An on-call schedule for a primary and a back-up neurointerventionalist; and A written protocol to accept the inter-facility transfer of acute ischemic stroke patients requiring endovascular therapy that includes communication and feedback to the sending facility. In addition to meeting the requirements of COMAR 30.08.11.10, a neurointerventionalist shall have: 4 or more hours of category 1 or 2 CME credits per year related to stroke care; and Performed 15 mechanical thrombectomies over the past 12 months or 30 over the past 24 months. In addition to meeting the requirements of COMAR 30.08.11.11, the emergency department clinical staff who triage or care for acute stroke patients shall be educated, by the hospital, on mechanical thrombectomy protocols. A hospital designated as a thrombectomy-capable primary stroke center shall meet the requirements of COMAR 30.08.11.12. In addition to meeting the requirements of COMAR 30.08.11.13, a hospital designated as a thrombectomy-capable primary stroke center shall: Have written policies ensuring that: Transfer of patients from another facility is appropriate and patients are received in a timely manner; and All stroke patients will receive medical care commensurate with the hospital’s designation as a thrombectomy-capable primary stroke center; Have written procedures demonstrating the ability to care for two complex interventional radiology stroke patients at one time, using appropriate clinical staff; Have written documentation demonstrating on-call and back-up on-call schedules for physicians and staff for 24/7 coverage; Have written care protocols for advanced treatment of complex stroke patients, including, but not limited to, acute ischemic stroke patients and acute intra-arterial therapeutic interventions; and Document and review the scope of practice and the roles and responsibilities of nurse practitioners and physician assistants providing care to the acute stroke patient in the intensive care unit, the emergency department, and the stroke unit. In addition to meeting the requirements of COMAR 30.08.14, a hospital designated as a thrombectomy-capable primary stroke center shall: Monitor and demonstrate 24-hour post-procedure stroke and death rates of less than or equal to 1 percent for diagnostic neuro-angiography; Monitor documentation of the reasons potentially eligible ischemic stroke patients did not receive mechanical thrombectomy; Monitor and demonstrate tracking and trending of modified Rankin Scores (mRS) at 90 days post-discharge on patients with acute ischemic stroke who received mechanical endovascular reperfusion therapy; In cases where mechanical endovascular reperfusion therapy is appropriate, achieve door-to-device times, arrival to first pass of thrombectomy device, in 50 percent or more of eligible acute ischemic stroke patients within 120 minutes for direct arriving patients and within 60 minutes for inter-facility transfer patients treated with endovascular therapy; and Demonstrate progress towards reducing door-to-device times, arrival to first pass of thrombectomy device in 50 percent or more of eligible acute ischemic stroke patients within 90 minutes for direct arriving patients. Education Article, §13-509, Annotated Code of Maryland Effective date: January 1, 2022 (48:22 Md. R. 939)