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<chapter num="20" heading="Intermediate Care Facilities for Individuals with Intellectual Disabilities or Persons with Related Conditions (ICF/IID)" title_num="10" subtitle_num="07">
  <regulation prefix="Regulation" num=".01" heading="Scope.">
    <text>This chapter applies to any person, whether public or private, operating a facility that:</text>
    <paragraph num="A.">
      <text>Provides health-related services on a regular basis to individuals:</text>
      <paragraph num="(1)">
        <text>Who do not require hospital care; and</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Whose mental or physical condition requires services that:</text>
        <paragraph num="(a)">
          <text>Are above the level of room and board; and</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Can be made available only through institutional facilities; and</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="B.">
      <text>Has as its primary purpose the provision of health rehabilitative services for individuals with an intellectual disability or related conditions.</text>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".02" heading="Applicability of Health-General Article, Annotated Code of Maryland.">
    <text>An intermediate care facility for individuals with intellectual disabilities or persons with related conditions (ICF/IID) shall be considered:</text>
    <paragraph num="A.">
      <text>A “related institution” under Health-General Article, §19-301, Annotated Code of Maryland, and shall be governed by the provisions of Title 19, Subtitle 3 of that article; and</text>
    </paragraph>
    <paragraph num="B.">
      <text>A provider of “services” under Health-General Article, §7-101, Annotated Code of Maryland, and shall be governed by the applicable provisions of Title 7 of that article including:</text>
      <paragraph num="(1)">
        <text>Subtitle 4: Provisions of Services;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Subtitle 5: State Residential Centers for Individuals With Mental Retardation if the facility is operated by the State;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Subtitle 8: Transfers; and</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Subtitle 10: Rights of Individuals.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".03" heading="Definitions.">
    <paragraph num="A.">
      <text>In this chapter, the following terms have the meanings indicated.</text>
    </paragraph>
    <paragraph num="B.">
      <text>Terms Defined.</text>
      <paragraph num="(1)">
        <text>“Department” means the Maryland Department of Health.</text>
      </paragraph>
      <paragraph num="(2)">
        <text>“Facility” means an intermediate care facility for individuals with intellectual disabilities or persons with related conditions (ICF/IID) within the scope of this chapter.</text>
      </paragraph>
      <paragraph num="(3)">
        <text>“License” means a license issued by the Secretary to operate a facility.</text>
      </paragraph>
      <paragraph num="(4)">
        <text>“Secretary” means the Secretary of Health.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".04" heading="Licensing Procedure.">
    <paragraph num="A.">
      <text>A person shall be licensed by the Secretary before the person may operate a facility in the State.</text>
    </paragraph>
    <paragraph num="B.">
      <text>An applicant for a license shall:</text>
      <paragraph num="(1)">
        <text>Submit to the Secretary an application:</text>
        <paragraph num="(a)">
          <text>In the form and manner prescribed by the Secretary on the written or electronic form provided by the Secretary; and</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Signed and verified by the applicant; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(2)">
        <text>Pay to the Secretary an application fee in the amount provided in COMAR 10.07.15.</text>
      </paragraph>
    </paragraph>
    <paragraph num="C.">
      <text>The Secretary shall issue a license to an applicant who meets the requirements of these regulations.</text>
    </paragraph>
    <paragraph num="D.">
      <text>A license authorizes the licensee to operate a facility while it is effective and is not transferable.</text>
    </paragraph>
    <paragraph num="E.">
      <text>Term and Renewal of License.</text>
      <paragraph num="(1)">
        <text>A license expires on the first anniversary of its effective date unless it is renewed for a 1-year term as provided in this section.</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Before the license expires, the licensee may renew it for another 1-year term, if the licensee submits to the Secretary:</text>
        <paragraph num="(a)">
          <text>A renewal application in the form and manner prescribed by the Secretary on the written or electronic form provided by the Secretary;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Satisfactory evidence of compliance with any requirement of the regulations for license renewal; and</text>
        </paragraph>
        <paragraph num="(c)">
          <text>The license renewal fee provided in COMAR 10.07.15.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="F.">
      <text>The Secretary may:</text>
      <paragraph num="(1)">
        <text>Deny a license to any applicant;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Deny the renewal of a license to a licensee; or</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Revoke a license of a licensee if the applicant or licensee does not meet the requirements of this chapter.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".05" heading="Standards of Operation.">
    <paragraph num="A.">
      <text>General. Whether or not a facility participates in Medicare or Medicaid, the facility shall meet the requirements set forth in 42 CFR § 483.400 et seq., which is incorporated by reference.</text>
    </paragraph>
    <paragraph num="B.">
      <text>Safety and Sanitation. The facility, its grounds, fixtures and equipment shall be:</text>
      <paragraph num="(1)">
        <text>Maintained in good repair, clean, and attractive;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Free of unnecessary accumulations of personal property or debris; and</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Free of hazards, insects, and rodents.</text>
      </paragraph>
    </paragraph>
    <paragraph num="C.">
      <text>Infection Control. The administrator shall:</text>
      <paragraph num="(1)">
        <text>Establish policies and procedures to investigate, control, and prevent infections in the facility; and</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Ensure that facility staff follow these policies and procedures.</text>
      </paragraph>
    </paragraph>
    <paragraph num="D.">
      <text>Personnel.</text>
      <paragraph num="(1)">
        <text>The administrator shall provide orientation and training for all staff and volunteers.</text>
      </paragraph>
      <paragraph num="(2)">
        <text>If the center provides care for individuals with Alzheimer's disease or related disorders:</text>
        <paragraph num="(a)">
          <text>The administrator shall provide annual in-service education on the care of individuals with dementia; and</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Each employee shall complete an instructional unit on dementia as described in COMAR 10.07.02.40H before the later of:</text>
          <paragraph num="(i)">
            <text>180 days from beginning of employment, or</text>
          </paragraph>
          <paragraph num="(ii)">
            <text>One year from the effective date of these regulations.</text>
          </paragraph>
        </paragraph>
      </paragraph>
      <paragraph num="(3)">
        <text>Employee Health Screening. A facility shall obtain certification that an employee or volunteer is free from tuberculosis in a communicable form as provided in Regulation .06 only if the employee or volunteer:</text>
        <paragraph num="(a)">
          <text>Will be involved in the direct care of tuberculosis patients; or</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Is an immigrant from Africa, Asia, or Latin America.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="E.">
      <text>Emergency Management Plans. State residential centers shall develop an emergency plan for all types of emergencies and disasters that shall include:</text>
      <paragraph num="(1)">
        <text>Procedures that will be followed before, during, and after an emergency to address the following:</text>
        <paragraph num="(a)">
          <text>The evacuation, transportation, or 72-hour shelter-in-place of individuals and staff served;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Holding an annual practice drill coordinated with local emergency planners for sheltering-in-place or evacuating;</text>
        </paragraph>
        <paragraph num="(c)">
          <text>Preparing an after action report and improvement plan after drills that evaluates the plan and takes corrective actions;</text>
        </paragraph>
        <paragraph num="(d)">
          <text>Ensuring that individuals served and staff have identification with current health, contact, and other important information that is immediately accessible in the event of evacuation;</text>
        </paragraph>
        <paragraph num="(e)">
          <text>The role of the resident, family member, or legal representative in the event of evacuation;</text>
        </paragraph>
        <paragraph num="(f)">
          <text>Arranging for medical needs and other accommodations for individuals served and staff at alternative facilities or shelters; and</text>
        </paragraph>
        <paragraph num="(g)">
          <text>Establishing a communication protocol among all appropriate parties that includes redundant communication means;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(2)">
        <text>The notification to families, staff, and respective DDA regional office regarding the action that will be taken concerning the safety and well-being of the individuals served;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>The staff coverage, organization, and assignment of responsibilities that includes:</text>
        <paragraph num="(a)">
          <text>Planning staff coverage needs for ongoing shelter-in-place or evacuations;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Identifying staff members available to report for work or remain during extended periods; and</text>
        </paragraph>
        <paragraph num="(c)">
          <text>Establishing staff notification and recall contingency plans and procedures;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(4)">
        <text>The continuity of operations, including, but not limited to, redundant communications systems, preservation of records and electronic data, the procurement of essential goods, equipment, and services, plans to secure vacated facilities, and the relocation to alternate facilities;</text>
      </paragraph>
      <paragraph num="(5)">
        <text>Procedures to:</text>
        <paragraph num="(a)">
          <text>Backup and electronically store off-site, appropriate records and data of consumers and staff and facility documents, for access under emergency conditions; and</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Ensure access to an electronic copy of the emergency plans when requested by local, State, or federal emergency management organizations;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(6)">
        <text>Provisions to ensure that the facility's emergency and disaster plans are shared with local emergency management organizations for the purpose of coordinating local emergency planning;</text>
      </paragraph>
      <paragraph num="(7)">
        <text>An executive summary of the evacuation procedures that shall be provided to the family member of a resident on request; and</text>
      </paragraph>
      <paragraph num="(8)">
        <text>A summary statement of the facility's community surge capacity abilities.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".06" heading="Tuberculosis Screening.">
    <paragraph num="A.">
      <text>An employee or volunteer may be certified as required in Regulation .05D(3) in one of the following four ways:</text>
      <paragraph num="(1)">
        <text>If the individual has documentation of a negative tuberculin test by the Mantoux method within the past 24 months and has, by history, no contact with a person with tuberculosis in a communicable form subsequent to this documentation or no symptoms consistent with tuberculosis, the individual shall be considered to be a negative tuberculin reactor and to be free from tuberculosis in a communicable form. Further skin testing may not be necessary except for epidemiologic diagnostic purposes which may be required by the local health officer or the Department.</text>
      </paragraph>
      <paragraph num="(2)">
        <text>If the individual does not have documentation of a negative tuberculin test by the Mantoux method within the past 24 months and does not have a history of having had a positive tuberculin test by the Mantoux method, the following procedure shall be done:</text>
        <paragraph num="(a)">
          <text>Five Tuberculin Units (TU) of Purified Protein Derivative (PPD) shall be administered intradermally and the results read 48—72 hours subsequent to the administration of the test;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>An individual with induration of 5—9 mm and no history of contact with a person with tuberculosis in a communicable form or an individual with induration of 0—4 mm shall be considered to be a negative tuberculin reactor and to be free from tuberculosis in a communicable form;</text>
        </paragraph>
        <paragraph num="(c)">
          <text>An individual with induration of 5—9 mm and a history of contact with a person with tuberculosis in a communicable form or an individual with induration of 10 mm or more shall be considered to be a positive tuberculin reactor and shall be handled as described in §A(3)(a),(b), and (c), of this regulation.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(3)">
        <text>If the individual is a positive tuberculin reactor as defined in §A(2)(c), of this regulation, or if the individual has a history of a positive tuberculin test by the Mantoux method without documentation of having received an adequate course of therapy, as defined by the local health officer, for tuberculosis disease or received adequate prophylaxis, as defined by the local health officer, for tuberculosis infection, the following procedure shall be done:</text>
        <paragraph num="(a)">
          <text>If the individual does not have documentation of a negative chest X-ray within the past 12 months, the individual shall be evaluated by a chest X-ray. If the chest X-ray is negative, the individual shall be considered to be free from tuberculosis in a communicable form and shall have a repeat chest X-ray in 12 months, unless isoniazid therapy is instituted, in which case the second chest X-ray is unnecessary.</text>
        </paragraph>
        <paragraph num="(b)">
          <text>If the individual has documentation of a negative chest X-ray within the past 12 months, the individual shall be considered to be free from tuberculosis in a communicable form and shall have a repeat chest X-ray 12 months after the most recent documented chest X-ray unless isoniazid therapy has been instituted, in which case the second chest X-ray is unnecessary.</text>
        </paragraph>
        <paragraph num="(c)">
          <text>If the individual has had two successive negative chest X-rays 12 months apart, no further chest X-rays are necessary and the individual shall be considered to be free from tuberculosis in a communicable form unless the individual has symptoms consistent with tuberculosis.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(4)">
        <text>If the individual has documentation of an adequate course of therapy, approved by the local health officer, for tuberculosis disease or adequate prophylaxis, approved by the local health officer, for tuberculosis infection, no further chest X-rays are necessary and the individual shall be considered to be free from tuberculosis in a communicable form unless the individual has symptoms consistent with tuberculosis.</text>
      </paragraph>
    </paragraph>
    <paragraph num="B.">
      <text>The facility shall instruct each employee and volunteer in the signs and symptoms of active tuberculosis and advise the individual to seek immediate medical care should the individual detect these signs or symptoms.</text>
    </paragraph>
    <paragraph num="C.">
      <text>If the individual meets any of the following criteria, the facility shall have written policies and procedures, acceptable to the Department, for the evaluation, management, and surveillance of this individual:</text>
      <paragraph num="(1)">
        <text>A history of tuberculosis or tuberculosis infection without documentation of adequate treatment as defined and determined by the local health officer;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Is currently being treated for tuberculosis disease or tuberculosis infection;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Has chest X-rays consistent with tuberculosis without documentation of adequate treatment as defined and determined by the local health officer; or</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Symptoms consistent with tuberculosis or a history of contact with a person with tuberculosis in a communicable form within the past 12 months.</text>
      </paragraph>
    </paragraph>
    <paragraph num="D.">
      <text>The facility shall maintain the following records:</text>
      <paragraph num="(1)">
        <text>Results of Mantoux tests, recorded in millimeters of induration with dates of administration, dates of reading and results of tests;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Results of X-rays required in §A(3)(a),(b), and (c), of this regulation; and</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Documentation of any Mantoux test, chest X-ray, chemotherapy, and chemoprophylaxis which is the basis for the certification that the individual is free from tuberculosis in a communicable form.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".07" heading="Inspections.">
    <paragraph num="A.">
      <text>The Department shall inspect each facility at least annually to determine compliance with these regulations.</text>
    </paragraph>
    <paragraph num="B.">
      <text>A licensed facility and any facility applying for a license shall be open to inspection by the Department at all times.</text>
    </paragraph>
  </regulation>
  <annotations>
    <annotation type="Authority">Health-General Article, §§19-318, 19-320, and 19-323, Annotated Code of Maryland</annotation>
    <annotation type="History" subtype="Administrative History">Effective date: December 28, 1987 (14:26 Md. R. 2747)</annotation>
    <annotation type="History" subtype="Administrative History">(COMAR 10.07.20 amended and transferred from COMAR 10.22.04 Public and Private Residential Care Facilities Serving the Mentally Retarded (ICF-MR))</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .01B amended effective January 20, 2014 (41:1 Md. R. 13)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .02 amended effective January 20, 2014 (41:1 Md. R. 13)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .03B amended effective January 20, 2014 (41:1 Md. R. 13)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .04B, E amended effective March 13, 2017 (44:5 Md. R. 292)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .05A amended effective February 20, 1989 (16:3 Md. R. 342)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .05E adopted effective December 17, 2007 (34:25 Md. R. 2210)</annotation>
  </annotations>
</chapter>