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<chapter num="04" heading="Data Collection and Quality Management" title_num="30" subtitle_num="08">
  <regulation prefix="Regulation" num=".01" heading="Responsibilities of MIEMSS.">
    <text>MIEMSS shall:</text>
    <paragraph num="A.">
      <text>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;</text>
    </paragraph>
    <paragraph num="B.">
      <text>Establish criteria to identify patients to be included in the State trauma registry;</text>
    </paragraph>
    <paragraph num="C.">
      <text>Collect data about patients to be included in the State trauma registry from:</text>
      <paragraph num="(1)">
        <text>EMS providers;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Hospitals, both designated and nondesignated including, but not limited to:</text>
        <paragraph num="(a)">
          <text>The primary adult resource center;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Level I trauma centers;</text>
        </paragraph>
        <paragraph num="(c)">
          <text>Level II trauma centers;</text>
        </paragraph>
        <paragraph num="(d)">
          <text>Level III trauma centers; and</text>
        </paragraph>
        <paragraph num="(e)">
          <text>Maryland Trauma Specialty Referral Centers as defined in Health-General Article, §19-130(a)(3), Annotated Code of Maryland;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(3)">
        <text>Office of Medical Examiner reports; and</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Other sources outside of the trauma and specialty care systems including, but not limited to:</text>
        <paragraph num="(a)">
          <text>Death certificates,</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Hospital inpatient discharge data,</text>
        </paragraph>
        <paragraph num="(c)">
          <text>Health care provider and third-party payer billing data, and</text>
        </paragraph>
        <paragraph num="(d)">
          <text>Law enforcement agency records;</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="D.">
      <text>Require hospitals to have a case specific patient identifier common to all data sources used in the State trauma registry; and</text>
    </paragraph>
    <paragraph num="E.">
      <text>Establish procedures and specifications for electronic and hard copy submission of data.</text>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".02" heading="Trauma and Specialty Care Quality Management Plan.">
    <paragraph num="A.">
      <text>MIEMSS shall design a trauma and specialty care quality management plan for continued monitoring and evaluation of the State trauma and specialty care systems.</text>
    </paragraph>
    <paragraph num="B.">
      <text>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:</text>
      <paragraph num="(1)">
        <text>Demography;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Anatomy;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Physiology;</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Severity;</text>
      </paragraph>
      <paragraph num="(5)">
        <text>Epidemiology;</text>
      </paragraph>
      <paragraph num="(6)">
        <text>Resource utilization;</text>
      </paragraph>
      <paragraph num="(7)">
        <text>Quality improvement;</text>
      </paragraph>
      <paragraph num="(8)">
        <text>Outcomes; and</text>
      </paragraph>
      <paragraph num="(9)">
        <text>Finance.</text>
      </paragraph>
    </paragraph>
    <paragraph num="C.">
      <text>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.</text>
    </paragraph>
    <paragraph num="D.">
      <text>MIEMSS shall develop a system and reporting mechanism for quality improvement by:</text>
      <paragraph num="(1)">
        <text>Determining the data standards for the State trauma registry;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Setting forth the data standards for the State trauma registry in:</text>
        <paragraph num="(a)">
          <text>The Maryland State Trauma Registry Data Dictionary for Adult Patients for patients 15 years old and older; and</text>
        </paragraph>
        <paragraph num="(b)">
          <text>The Maryland State Trauma Registry Data Dictionary for Pediatric Patients for patients younger than 15 years old.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(3)">
        <text>Establishing protocols for quality monitoring, consistent with MIEMSS' most current data quality guidelines;</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Conducting studies to assess the completeness and accuracy of case identification and data collection; and</text>
      </paragraph>
      <paragraph num="(5)">
        <text>Ensuring that the data entered in the State trauma registry is complete and accurate.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".03" heading="Trauma and Specialty Care Quality Management Programs.">
    <paragraph num="A.">
      <text>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.</text>
    </paragraph>
    <paragraph num="B.">
      <text>The quality management program includes, but is not limited to, the requirements for trauma and specialty referral centers in COMAR 30.08.03.</text>
    </paragraph>
    <paragraph num="C.">
      <text>A designated trauma and specialty referral center shall have a system for continuous monitoring and trend analysis of trauma patient bypass status.</text>
    </paragraph>
    <paragraph num="D.">
      <text>Designated trauma and specialty referral centers shall participate in State trauma and specialty care quality management activities sponsored by MIEMSS.</text>
    </paragraph>
    <paragraph num="E.">
      <text>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.</text>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".04" heading="Use of State Trauma Registry and Specialty Care Data.">
    <text>MIEMSS may use State trauma registry and specialty care data to:</text>
    <paragraph num="A.">
      <text>Monitor and provide information necessary to evaluate major trauma or specialty patient care, outcome, and cost;</text>
    </paragraph>
    <paragraph num="B.">
      <text>Assess compliance of EMS providers, designated trauma and specialty referral centers, and other hospitals with the trauma and specialty care standards, regulations, and protocols;</text>
    </paragraph>
    <paragraph num="C.">
      <text>Provide information necessary for resource planning and management;</text>
    </paragraph>
    <paragraph num="D.">
      <text>Provide data for injury surveillance, analysis, and prevention programs; and</text>
    </paragraph>
    <paragraph num="E.">
      <text>Provide a data resource for research and education.</text>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".05" heading="Responsibilities of Emergency Medical Services Providers.">
    <paragraph num="A.">
      <text>Prehospital services shall provide prehospital MAIS runsheets or EMAIS patient care reports that include trauma or specialty care patient data about:</text>
      <paragraph num="(1)">
        <text>Trauma victims dead at the scene of the trauma;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Patients meeting State trauma or specialty triage criteria who are transported to a hospital;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Patients transported in accordance with interfacility transfer policies to receive a higher level of care or for special resources; and</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Patients transported to specialty referral centers.</text>
      </paragraph>
    </paragraph>
    <paragraph num="B.">
      <text>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.</text>
    </paragraph>
    <paragraph num="C.">
      <text>Designated trauma or specialty care centers shall use the patient criteria described in Regulation .01B and C of this chapter.</text>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".06" heading="Access to Trauma Registry and Specialty Care Information.">
    <paragraph num="A.">
      <text>Data that identifies individual patients, providers, and hospital outcomes is confidential.</text>
    </paragraph>
    <paragraph num="B.">
      <text>MIEMSS may only release confidential information:</text>
      <paragraph num="(1)">
        <text>As required by the Health Services Cost Review Commission under Health-General Article, §19-130, Annotated Code of Maryland; or</text>
      </paragraph>
      <paragraph num="(2)">
        <text>In accordance with:</text>
        <paragraph num="(a)">
          <text>The provisions of Health Occupations Article, Title 1, Subtitle 4, and §14-506, Annotated Code of Maryland; and</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Other criteria as developed by MIEMSS pertaining to patient confidentiality and quality management records.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="C.">
      <text>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.</text>
    </paragraph>
    <paragraph num="D.">
      <text>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.</text>
    </paragraph>
    <paragraph num="E.">
      <text>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.</text>
    </paragraph>
    <paragraph num="F.">
      <text>MIEMSS may not disclose confidential information to any person, except on request:</text>
      <paragraph num="(1)">
        <text>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;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>To a scientific research professional associated with a scientific research organization, if:</text>
        <paragraph num="(a)">
          <text>MIEMSS has reviewed and approved the research professional's written research proposal with respect to scientific merit and confidentiality safeguards, and</text>
        </paragraph>
        <paragraph num="(b)">
          <text>The data does not identify specific hospitals or patients; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(3)">
        <text>MIEMSS shall provide aggregate State trauma registry and specialty care data to hospitals, public or private agencies, and other interested parties for:</text>
        <paragraph num="(a)">
          <text>Prevention activities,</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Epidemiological or demographic studies, or</text>
        </paragraph>
        <paragraph num="(c)">
          <text>Education and research projects.</text>
        </paragraph>
      </paragraph>
    </paragraph>
  </regulation>
  <annotations>
    <annotation type="Authority">Education Article, §13-509, Annotated Code of Maryland</annotation>
    <annotation type="History" subtype="Administrative History">Effective date: March 24, 1997 (24:6 Md. R. 488)</annotation>
    <annotation type="History" subtype="Administrative History">Regulations .01—.04 amended effective July 1, 2002 (29:12 Md. R. 932)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .01 amended effective June 4, 2007 (34:11 Md. R. 972)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .02D amended effective June 4, 2007 (34:11 Md. R. 972)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .03E adopted effective December 15, 2003 (30:24 Md. R. 1746)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .05 amended effective June 4, 2007 (34:11 Md. R. 972)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .06 amended effective July 1, 2002 (29:12 Md. R. 932); December 19, 2005 (32:25 Md. R. 1947)</annotation>
  </annotations>
</chapter>