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<chapter num="12" heading="Neonatal Ambulance Service and Infant Transport" title_num="30" subtitle_num="09">
  <regulation prefix="Regulation" num=".01" heading="Scope.">
    <text>This chapter governs the operations of neonatal ambulance services and neonatal ambulances.</text>
  </regulation>
  <regulation prefix="Regulation" num=".02" heading="Requirements for a Neonatal Commercial Ambulance Service.">
    <paragraph num="A.">
      <text>A commercial ambulance service wishing to provide neonatal ambulance services shall comply with the requirements of this chapter in addition to the other applicable requirements of this subtitle.</text>
    </paragraph>
    <paragraph num="B.">
      <text>An ambulance service transporting neonates shall obtain a neonatal commercial ambulance service license.</text>
    </paragraph>
    <paragraph num="C.">
      <text>An applicant for a neonatal commercial ambulance service license shall submit an application to SOCALR on the required form.</text>
    </paragraph>
    <paragraph num="D.">
      <text>A completed application form shall be accompanied by documentation which states to SOCALR’s satisfaction that the commercial ambulance service has:</text>
      <paragraph num="(1)">
        <text>Retained two or more registered nurses who:</text>
        <paragraph num="(a)">
          <text>Meet the requirements of the Board of Nursing under COMAR 10.27.09.04 to provide nursing care to neonates during interfacility transport; and</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Agree to assume responsibility for patient care during the transport process;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(2)">
        <text>Retained one or more physicians who are board certified or are active candidates for board certification in neonatology who:</text>
        <paragraph num="(a)">
          <text>Possess current knowledge of the Maryland EMS System as required in COMAR 30.03.03.03B(4), as well as current knowledge of:</text>
          <paragraph num="(i)">
            <text>The effects of transport on the neonate; and</text>
          </paragraph>
          <paragraph num="(ii)">
            <text>The operation of neonatal transport equipment and ambulance communications equipment; and</text>
          </paragraph>
        </paragraph>
        <paragraph num="(b)">
          <text>Working with a neonatal or perinatal center, agree to:</text>
          <paragraph num="(i)">
            <text>Serve as medical director for the neonatal service;</text>
          </paragraph>
          <paragraph num="(ii)">
            <text>Provide medical direction to the commercial ambulance service's personnel-related neonatal care;</text>
          </paragraph>
          <paragraph num="(iii)">
            <text>Provide training as required in neonatal care; and</text>
          </paragraph>
          <paragraph num="(iv)">
            <text>Participate in a quality assurance program; and</text>
          </paragraph>
        </paragraph>
      </paragraph>
      <paragraph num="(3)">
        <text>If providing neonatal transport services in partnership with a hospital-based neonatal intensive care unit, a written MOU stating that all equipment and medications required to transport a neonate under this chapter will be readily available to the service.</text>
      </paragraph>
    </paragraph>
    <paragraph num="E.">
      <text>A licensed neonatal commercial ambulance service shall immediately advise SOCALR of any change in the medical director named in §D(2) of this regulation.</text>
    </paragraph>
    <paragraph num="F.">
      <text>A licensed neonatal commercial ambulance service may not transport a neonate from one hospital to another for a higher level of care unless the admitting hospital:</text>
      <paragraph num="(1)">
        <text>Is a perinatal center;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Is a neonatal center;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Before designation of perinatal centers by the EMS Board, has a certificate of need issued by the Maryland Health Resources Planning Commission for its neonatal intensive care unit or approval from Maryland Health Resources Planning Commission for a neonatal intensive care unit; or</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Before the EMS Board has completed the process of entering into an agreement with an out-of-State hospital to serve as an out-of-State perinatal referral center, possesses all government approvals required to operate a neonatal intensive care unit under the laws of the jurisdiction in which it is located including, if required, a certificate of need and all necessary licenses.</text>
      </paragraph>
    </paragraph>
    <paragraph num="G.">
      <text>Neonates.</text>
      <paragraph num="(1)">
        <text>Neonates being transferred  to a neonatal intensive care unit (NICU) shall be transported by a neonatal licensed transport service, as described in Regulation .04 of this chapter.</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Neonates being transferred to any acute care setting other than a NICU shall be transported by either:</text>
        <paragraph num="(a)">
          <text>A neonatal licensed transport service; or</text>
        </paragraph>
        <paragraph num="(b)">
          <text>A specialty care transport (SCT) service with an RN who has age-appropriate competencies and equipment.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="H.">
      <text>Infants. Infants being transferred to any acute care setting shall be transported by:</text>
      <paragraph num="(1)">
        <text>A neonatal licensed transport service;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>An SCT service with a staff who has age-appropriate competencies and equipment; or</text>
      </paragraph>
      <paragraph num="(3)">
        <text>An ALS unit that includes staff with age-appropriate competencies and equipment, only after a neonatal licensed transport or SCT service has reviewed the case and referred it to the ALS service.</text>
      </paragraph>
    </paragraph>
    <paragraph num="I.">
      <text>Neonates or Infants being transported for convalescent care at a rehabilitation hospital or long-term facility shall be transported by:</text>
      <paragraph num="(1)">
        <text>A neonatal licensed transport service;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>An SCT service with a staff who has age-appropriate competencies and equipment; or</text>
      </paragraph>
      <paragraph num="(3)">
        <text>An ALS unit that includes staff with age-appropriate competencies and equipment, only after a neonatal licensed transport or SCT service has reviewed the case and referred it to the ALS service.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".03" heading="Additional Requirements for Services.">
    <paragraph num="A.">
      <text>An applicant for a neonatal commercial ambulance license shall submit an application to SOCALR.</text>
    </paragraph>
    <paragraph num="B.">
      <text>A licensed neonatal commercial ambulance service may only provide neonatal transport service with an ALS or SCT licensed commercial ambulance that meets all the requirements of this chapter.</text>
    </paragraph>
    <paragraph num="C.">
      <text>A licensed neonatal commercial ambulance service shall ensure the patient is secured in a patient restraint device appropriate for the patient’s age and weight.</text>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".04" heading="Staffing.">
    <paragraph num="A.">
      <text>A licensed commercial ambulance, when providing neonatal service, shall be staffed by:</text>
      <paragraph num="(1)">
        <text>A driver who meets the requirements in COMAR 30.09.07.02A(4)(a); and</text>
      </paragraph>
      <paragraph num="(2)">
        <text>At least two individuals, in addition to the driver:</text>
        <paragraph num="(a)">
          <text>At least one of whom shall be a registered nurse or physician with advanced training in the care of neonates; and</text>
        </paragraph>
        <paragraph num="(b)">
          <text>The second individual shall be a Maryland licensed health care provider, including a physician, registered nurse, respiratory therapist, nurse practitioner, physician assistant, paramedic, or CRT, who is medically qualified to care for the patient and has additional training needed to care for neonatal patients during interfacility transport including:</text>
          <paragraph num="(i)">
            <text>Knowledge of the Maryland EMS System;</text>
          </paragraph>
          <paragraph num="(ii)">
            <text>The effects of transport on the neonate; and</text>
          </paragraph>
          <paragraph num="(iii)">
            <text>The operation of neonatal transport equipment and ambulance communications equipment.</text>
          </paragraph>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="B.">
      <text>When more than one patient is transported simultaneously in the same ambulance:</text>
      <paragraph num="(1)">
        <text>There shall be at least one registered nurse or physician with advanced training in the care of neonates present for each neonatal patient; and</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Each patient shall be secured in a separate patient restraint device appropriate for the patients age and weight.</text>
      </paragraph>
    </paragraph>
    <paragraph num="C.">
      <text>All personnel attending to neonatal patients shall:</text>
      <paragraph num="(1)">
        <text>Prior to transporting neonatal patients, successfully complete:</text>
        <paragraph num="(a)">
          <text>The Neonatal Resuscitation Program; and</text>
        </paragraph>
        <paragraph num="(b)">
          <text>The S.T.A.B.L.E. Program;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(2)">
        <text>Maintain a current:</text>
        <paragraph num="(a)">
          <text>Neonatal Resuscitation Program Provider Course Completion Card; and</text>
        </paragraph>
        <paragraph num="(b)">
          <text>S.T.A.B.L.E. Program Completion Certificate; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(3)">
        <text>If a physician:</text>
        <paragraph num="(a)">
          <text>Maintain board certification in neonatology;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Maintain board certification in pediatric critical care; or</text>
        </paragraph>
        <paragraph num="(c)">
          <text>Be a licensed physician serving in the second or third year of a neonatology or pediatric critical care fellowship.</text>
        </paragraph>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".05" heading="Additional Record-Keeping and Quality Assurance Requirements.">
    <paragraph num="A.">
      <text>In addition to the information required in COMAR 30.09.08, the following information shall be documented on the patient runsheet:</text>
      <paragraph num="(1)">
        <text>Mother's name;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Name of the referring hospital;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Name of the referring physician;</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Name of the receiving hospital;</text>
      </paragraph>
      <paragraph num="(5)">
        <text>Name of the receiving physician;</text>
      </paragraph>
      <paragraph num="(6)">
        <text>Date of birth;</text>
      </paragraph>
      <paragraph num="(7)">
        <text>Time of birth;</text>
      </paragraph>
      <paragraph num="(8)">
        <text>Gestational age of the patient;</text>
      </paragraph>
      <paragraph num="(9)">
        <text>Weight of the patient;</text>
      </paragraph>
      <paragraph num="(10)">
        <text>Primary reason for transport;</text>
      </paragraph>
      <paragraph num="(11)">
        <text>Names and license or certification level of the commercial ambulance driver and all personnel;</text>
      </paragraph>
      <paragraph num="(12)">
        <text>Time the request for transport was received by the commercial ambulance service;</text>
      </paragraph>
      <paragraph num="(13)">
        <text>Time the transport team departed from base;</text>
      </paragraph>
      <paragraph num="(14)">
        <text>Time the transport team arrived at the referral hospital;</text>
      </paragraph>
      <paragraph num="(15)">
        <text>Time the transport team departed from the referral hospital;</text>
      </paragraph>
      <paragraph num="(16)">
        <text>Time the transport team arrived at the receiving hospital; and</text>
      </paragraph>
      <paragraph num="(17)">
        <text>Care provided during the transport.</text>
      </paragraph>
    </paragraph>
    <paragraph num="B.">
      <text>A copy of the runsheet and all documentation of patient care during the transport shall be submitted in accordance with COMAR 30.09.08.06D.</text>
    </paragraph>
    <paragraph num="C.">
      <text>A licensed neonatal commercial ambulance service shall have a quality assurance program required by COMAR 30.03.04 which shall include:</text>
      <paragraph num="(1)">
        <text>A review by registered nurses and physicians of patient care provided during neonatal transport;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>A review by the program medical director of each specialty care transport:</text>
        <paragraph num="(a)">
          <text>Requiring a change in the plan of care during transport;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>In which the patient’s condition worsened during transport;</text>
        </paragraph>
        <paragraph num="(c)">
          <text>Requiring a change in destination during transport; or</text>
        </paragraph>
        <paragraph num="(d)">
          <text>During which there was an unexpected outcome or event;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(3)">
        <text>Written documentation of reviews of neonatal transports which shall be available to SOCALR upon request; and</text>
      </paragraph>
      <paragraph num="(4)">
        <text>A quality assurance process for call taking, call screening, and dispatch.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".06" heading="Equipment Requirements.">
    <paragraph num="A.">
      <text>A licensed neonatal commercial ambulance service shall comply with COMAR 30.09.11.03 when transporting a neonate.</text>
    </paragraph>
    <paragraph num="B.">
      <text>There shall be a written maintenance plan for all medical devices used on neonatal commercial ambulances approved by SOCALR, which shall provide that:</text>
      <paragraph num="(1)">
        <text>All specialized medical devices used during transport shall:</text>
        <paragraph num="(a)">
          <text>If provided by the hospital, be maintained by the hospital; or</text>
        </paragraph>
        <paragraph num="(b)">
          <text>If provided by the licensed commercial ambulance service, be maintained as recommended by the manufacturer; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(2)">
        <text>The licensed commercial service providing specialized medical devices used during transport shall maintain records documenting maintenance and repair services.</text>
      </paragraph>
    </paragraph>
    <paragraph num="C.">
      <text>All on-board medical devices shall be secured to the satisfaction of SOCALR.</text>
    </paragraph>
    <paragraph num="D.">
      <text>The following equipment shall be carried in a neonatal ambulance:</text>
      <paragraph num="(1)">
        <text>All equipment listed in the current Neonatal equipment list approved by SOCALR;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Any additional equipment required for the care of the patient as determined by consultation between the referring and receiving physicians; and</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Additional medications approved for use by the neonatal service medical director to meet the needs of the types of patients being transported.</text>
      </paragraph>
    </paragraph>
    <paragraph num="E.">
      <text>A list of the additional medications used by the neonatal service and approved by the neonatal service medical director shall be provided to SOCALR and approved by the State EMS Medical Director annually upon license renewal, and shall be available on each ambulance when in use for a neonatal transport.</text>
    </paragraph>
    <paragraph num="F.">
      <text>SOCALR shall be notified in writing of any changes to the list of additional medications used by the neonatal transport service within 7 days of the change.</text>
    </paragraph>
    <paragraph num="G.">
      <text>There shall be sufficient quantities of medications to care for one neonatal patient for the longer of:</text>
      <paragraph num="(1)">
        <text>1 hour; or</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Two times the estimated time of transport.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <annotations>
    <annotation type="Authority">Education Article, §13-515, Annotated Code of Maryland</annotation>
    <annotation type="History" subtype="Administrative History">Effective date: October 12, 1992 (19:20 Md. R. 1816)</annotation>
    <annotation type="History" subtype="Administrative History">Chapter recodified from COMAR 14.22.12 to COMAR 30.09.12, August, 1997</annotation>
    <annotation type="History" subtype="Administrative History">Regulations .01—.08, Enforcement, repealed effective January 10, 2000 (26:27 Md. R. 2017)</annotation>
    <annotation type="History" subtype="Administrative History">Regulations .01—.07, Neonatal Ambulance Service, adopted effective January 10, 2000 (26:27 Md. R. 2017)</annotation>
    <annotation type="History" subtype="Administrative History">Chapter revised effective September 1, 2014 (41:17 Md. R. 972)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .02 amended effective May 3, 2021 (48:9 Md. R. 361)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .03 amended effective May 3, 2021 (48:9 Md. R. 361)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .04A amended effective May 3, 2021 (48:9 Md. R. 361); October 16, 2023 (50:20 Md. R. 889)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .04C amended effective October 16, 2023 (50:20 Md. R. 889)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .05B amended effective May 3, 2021 (48:9 Md. R. 361)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .06 amended effective May 3, 2021 (48:9 Md. R. 361)</annotation>
  </annotations>
</chapter>