<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".04" citation="COMAR 10.06.01.04" title_num="10" subtitle_num="06" chapter_num="01" heading="Reporting Procedures.">
  <paragraph num="A.">
    <text>Sources of Reports and to Whom to Report.</text>
    <paragraph num="(1)">
      <text>An institution, as specified in Health-General Article, §18-202, Annotated Code of Maryland, and a health care provider who knows of a case of a reportable disease, condition, outbreak, or unusual manifestation shall report it to a health officer.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>A teacher at any public, private, or parochial school or a child care provider at any child care facility shall report an occurrence of a reportable disease or condition, an outbreak, or an unusual manifestation as set forth in Regulation .03 of this chapter to the principal, school nurse, or superintendent or assistant superintendent or designee, who shall transmit to a health officer a report of the name and address of a child who appears to have a reportable communicable disease or who has been exposed to a reportable communicable disease.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>The master or person in charge of a vessel or aircraft within the territory of the State shall report to the Secretary or a health officer at the nearest port of landing or entry, all known facts relating to the illness and physical condition of an individual aboard the vessel or aircraft who may have a reportable disease or condition, an outbreak, or an unusual manifestation.</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Directors of Medical Laboratories or Laboratories that Possess Biological Agents as Defined in COMAR 10.10.11.03B(8).</text>
      <paragraph num="(a)">
        <text>The director of a medical laboratory or a laboratory that possesses a biological agent as defined in COMAR 10.10.11.03B(8) shall report:</text>
        <paragraph num="(i)">
          <text>Laboratory evidence of a reportable condition as specified in Regulation .03C of this chapter from examination of a human specimen acquired from an individual in this State; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Evidence of any other condition as requested by the Secretary.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>The director of a medical laboratory or a laboratory that possesses a biological agent as defined in COMAR 10.10.11.03B(8) located in a Maryland jurisdiction shall report to the health officer of that jurisdiction.</text>
      </paragraph>
      <paragraph num="(c)">
        <text>The director of a medical laboratory located outside of Maryland shall report to the Secretary.</text>
      </paragraph>
      <paragraph num="(d)">
        <text>If a medical laboratory or a laboratory that possesses a biological agent as defined in COMAR 10.10.11.03B(8) forwards clinical materials out of State for testing, the originating medical laboratory or a laboratory that possesses a biological agent as defined in COMAR 10.10.11.03B(8) shall comply with this subsection by:</text>
        <paragraph num="(i)">
          <text>Reporting the results and submitting the clinical materials; or</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Ensuring that the results are reported and materials submitted.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(e)">
        <text>When more than one specimen is taken from a patient during one disease episode, the director of a medical laboratory or a laboratory that possesses a biological agent as defined in COMAR 10.10.11.03B(8) need not report every test result of a specimen that shows evidence of the same disease in that patient if:</text>
        <paragraph num="(i)">
          <text>At least one positive test result is reported; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>A health officer has agreed that all test reports do not need to be reported.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(5)">
      <text>Any individual having knowledge of an animal bite shall report the bite according to the requirements of COMAR 10.06.02.</text>
    </paragraph>
    <paragraph num="(6)">
      <text>The owner or operator of a food establishment as defined in Health-General Article, §21-301, Annotated Code of Maryland, shall report to a health officer an occurrence of a reportable disease or condition, an outbreak, or an unusual manifestation.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>Method and Content of Reports.</text>
    <paragraph num="(1)">
      <text>A person, as listed in §A(1)—(4) of this regulation, shall report:</text>
      <paragraph num="(a)">
        <text>In writing on a form provided by the Secretary; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>In a format approved by the Secretary, when electronic submittal is available.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>The report shall include at a minimum the:</text>
      <paragraph num="(a)">
        <text>Date of the report;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Patient's name including first and last names and middle initial;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Residence address of the patient including:</text>
        <paragraph num="(i)">
          <text>House or apartment number;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Street;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>City or town;</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>State; and</text>
        </paragraph>
        <paragraph num="(v)">
          <text>Zip code;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(d)">
        <text>Telephone number including area code;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Date of birth;</text>
      </paragraph>
      <paragraph num="(f)">
        <text>Sex;</text>
      </paragraph>
      <paragraph num="(g)">
        <text>Race;</text>
      </paragraph>
      <paragraph num="(h)">
        <text>Ethnicity;</text>
      </paragraph>
      <paragraph num="(i)">
        <text>Pregnancy status if applicable; and</text>
      </paragraph>
      <paragraph num="(j)">
        <text>Other epidemiologic information as specified by the Secretary or the health officer.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>In addition to what is specified in §B(2) of this regulation, institutions and health care providers, school and child care facility personnel, and masters of vessels or aircraft as listed in §A(1)—(3) of this regulation shall report:</text>
      <paragraph num="(a)">
        <text>The date of onset of symptoms;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The diagnosis;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>For syphilis, gonococcal infection, and Chlamydia trachomatis infection, the treatment given; and</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Any laboratory information supporting the diagnosis of the disease or condition, as requested.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>A director of a medical laboratory, in addition to what is specified in §B(2) of this regulation, shall report the:</text>
      <paragraph num="(a)">
        <text>Name, address, telephone number, and federal Clinical Laboratory Improvement Amendments (CLIA) certificate number of the laboratory performing the test;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Date the specimen was received by the laboratory;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Accession number or other unique identifier for the specimen;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Type of test performed and the results, including:</text>
        <paragraph num="(i)">
          <text>Reference range;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Quantitative results; and</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Results of speciating, grouping, or typing of organisms;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(e)">
        <text>Date of specimen collection;</text>
      </paragraph>
      <paragraph num="(f)">
        <text>Type of specimen, for example, blood, urine, stool, or mucus, and the site of specimen collection, for example, cervix, eye;</text>
      </paragraph>
      <paragraph num="(g)">
        <text>Date of the laboratory result;</text>
      </paragraph>
      <paragraph num="(h)">
        <text>Name, address including number and street, city, state, and zip code, and phone number including area code of the health care provider who ordered the test;</text>
      </paragraph>
      <paragraph num="(i)">
        <text>Name, address including number and street, city, state, and zip code, and phone number including area code of the facility that ordered the test; and</text>
      </paragraph>
      <paragraph num="(j)">
        <text>For hepatitis C infection:</text>
        <paragraph num="(i)">
          <text>Signal-to-cut-off ratios and critical values;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Hepatitis A IgM results; and</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Hepatitis B IgM test results.</text>
        </paragraph>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>Timing of Reports.</text>
    <paragraph num="(1)">
      <text>If the Secretary requires an immediate report, the person making the report:</text>
      <paragraph num="(a)">
        <text>Shall communicate directly with an individual in person or by telephone; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>May not leave a message on an answering device.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>A health care provider and a director of a medical laboratory shall report according to the time frame in Regulation .03C of this chapter.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>School and child care facility personnel, a master of a vessel or aircraft, and the owner or operator of a food establishment shall report immediately.</text>
    </paragraph>
    <paragraph num="(4)">
      <text>A health officer shall transmit to the Secretary, by mail or as otherwise specified by the Secretary, all information obtained:</text>
      <paragraph num="(a)">
        <text>Within 24 hours after receiving notice of a disease or condition listed in Regulation .03C of this chapter; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Within a shorter amount of time than 24 hours as specified by the Secretary.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(5)">
      <text>The Secretary shall transmit to the health officer of the jurisdiction where the patient resides, by mail or as otherwise specified by the Secretary, all information related to the notice of a reportable condition provided by a director of a medical laboratory located outside of Maryland:</text>
      <paragraph num="(a)">
        <text>Within 24 hours after receiving notice of a disease or condition listed in Regulation .03C of this chapter; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Within a shorter amount of time than 24 hours as specified by the Secretary.</text>
      </paragraph>
    </paragraph>
  </paragraph>
</regulation>