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<regulation prefix="Regulation" num=".34" citation="COMAR 10.07.01.34" title_num="10" subtitle_num="07" chapter_num="01" heading="Infection Prevention and Control Program.">
  <paragraph num="A.">
    <text>The hospital shall have an active hospital-wide program for the prevention, control, and investigation of communicable diseases and infections.</text>
  </paragraph>
  <paragraph num="B.">
    <text>Staffing.</text>
    <paragraph num="(1)">
      <text>The hospital shall designate qualified staff with training in infection prevention and control to be responsible for the implementation of the infection prevention and control program.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Additional clinical and support staff shall be provided for the infection prevention and control program based on the size and complexity of the hospital's services.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>Infection Prevention and Control Program.</text>
    <paragraph num="(1)">
      <text>The infection prevention and control program shall be based on nationally recognized, evidence-based standards.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The infection prevention and control program shall be developed using an interdisciplinary approach with input from:</text>
      <paragraph num="(a)">
        <text>Administrative staff;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Medical staff;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Pharmacy staff;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Laboratory personnel;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Nursing staff;</text>
      </paragraph>
      <paragraph num="(f)">
        <text>Physical plant personnel;</text>
      </paragraph>
      <paragraph num="(g)">
        <text>Employee health personnel;</text>
      </paragraph>
      <paragraph num="(h)">
        <text>Patient safety officer; and</text>
      </paragraph>
      <paragraph num="(i)">
        <text>Staff from other departments whose knowledge and experience would contribute to improved infection prevention and control.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>Written policies and procedures for the infection prevention and control program shall be established, implemented, maintained, and updated periodically.</text>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>Surveillance.</text>
    <paragraph num="(1)">
      <text>The hospital shall:</text>
      <paragraph num="(a)">
        <text>Have a process for the identification and surveillance of healthcare- associated infections;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Analyze and utilize surveillance data to monitor and improve infection control and healthcare outcomes; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Maintain a log of the identified infections.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>The infection prevention and control program shall include:</text>
      <paragraph num="(a)">
        <text>Processes for the monitoring and control of patients who have a communicable disease or infection to prevent its spread to other patients and staff;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>A process to identify and investigate the occurrence of outbreaks of communicable diseases or clusters of infections; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Reporting of infections, communicable diseases, and outbreaks to the local or State health department, as required by COMAR 10.06.01.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>When an outbreak occurs, the infection control staff shall have adequate resources and authority to ensure comprehensive and timely investigation and to implement control measures.</text>
    </paragraph>
  </paragraph>
  <paragraph num="E.">
    <text>Education.</text>
    <paragraph num="(1)">
      <text>The hospital shall provide education to all staff and, if appropriate, to the patient and visitors regarding the prevention and control of communicable diseases and infections. Educational activities shall address problems identified by the infection prevention and control program.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Nonclinical staff shall be included in infection prevention and control training consistent with their assigned responsibilities.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Attendance or participation in an educational program shall be recorded. Educational programs shall be evaluated not less than annually for effectiveness.</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Education related to infection prevention and control shall be included in the hospital's orientation program for all new employees, including appropriate contractual personnel.</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Physicians who are employed or who have privileges and who do not receive training through the hospital's new employee training program shall receive alternative orientation education on infection prevention and control practices and the hospital's infection prevention and control program.</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Outside agency staff shall receive sufficient training in the hospital's infection prevention and control policies and procedures to provide safe care to the patients.</text>
    </paragraph>
  </paragraph>
  <paragraph num="F.">
    <text>Prevention.</text>
    <paragraph num="(1)">
      <text>The hospital shall establish processes and programs to prevent the spread of communicable diseases and infections.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>A hospital's processes and programs to prevent the spread of communicable diseases and infections shall include at least the items listed in §F(3) of this regulation.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Required Processes and Programs.</text>
      <paragraph num="(a)">
        <text>Hand Hygiene.</text>
        <paragraph num="(i)">
          <text>The infection prevention and control program shall include activities to educate staff on the need for hand hygiene prior to and after any patient contact and as directed by accepted professional practice.</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Hand hygiene compliance by staff shall be monitored through the infection prevention and control program.</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>The infection prevention and control program shall maintain documentation of audits for compliance with this requirement.</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>Facilities and supplies to facilitate hand hygiene shall be provided and be accessible in all locations of the hospital where patient care is provided.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>Sanitation.</text>
        <paragraph num="(i)">
          <text>The hospital shall maintain a sanitary environment to prevent the spread of communicable diseases and infections.</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>The hospital shall have systems to maintain the environment in a clean and sanitary condition.</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Systems shall be provided to ensure that housekeeping, linen handling, waste disposal including medical waste, food handling, ventilation systems, water systems, and pest control meet acceptable federal and State standards and guidelines.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(c)">
        <text>Aseptic Technique. The hospital shall use aseptic techniques to prevent infections, including surgical site infections and device-associated infections.</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Immunocompromised Patients. The hospital shall use professionally accepted procedures to protect immunocompromised patients from infection.</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Standard Precautions. The hospital staff shall use standard precautions and other categories of isolation or precautions consistent with current Center for Disease Control (CDC) recommendations.</text>
      </paragraph>
      <paragraph num="(f)">
        <text>Equipment and Supplies.</text>
        <paragraph num="(i)">
          <text>The hospital shall have personal protective equipment, such as gloves, gowns, respirators, and masks or other facial protection for staff readily available.</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Supplies and equipment needed to prevent the spread of communicable diseases and infections shall be available in all patient care areas.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>Employee Health Program. The infection prevention and control program shall work in conjunction with the employee health program and include monitoring and identification of employee health concerns such as immunity to measles, mumps, rubella, and varicella (chicken pox).</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Immunizations for influenza shall be offered to staff and licensed independent practitioners. Reasons for refusal of the influenza vaccine by an employee shall be documented by the infection control or employee health program.</text>
    </paragraph>
  </paragraph>
  <paragraph num="G.">
    <text>Performance Improvement.</text>
    <paragraph num="(1)">
      <text>The infection prevention and control program shall include performance improvement and quality assurance measures to address the problems identified through the surveillance, control, and investigation of infections.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The hospital shall develop and implement interventions to address identified problems and monitor the effectiveness of interventions to control and prevent infections.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>The infection prevention and control program shall be incorporated into the hospital's performance improvement program.</text>
    </paragraph>
  </paragraph>
  <paragraph num="H.">
    <text>Patient Safety. The infection prevention and control program shall share data regarding healthcare-associated infections with the hospital's designated patient safety officer. Health care associated infections that meet the definition of a Level 1 adverse event shall be reported to the Department, and a root cause analysis submitted as required by COMAR 10.07.06.</text>
  </paragraph>
  <paragraph num="I.">
    <text>Reports to the Governing Body.</text>
    <paragraph num="(1)">
      <text>Infection control data including reports on the numbers and types of healthcare-associated infections shall be reported to the hospital's medical staff and governing body on an ongoing basis.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The hospital leadership shall support infection prevention and control activities, including the provision of adequate resources for the program.</text>
    </paragraph>
  </paragraph>
  <paragraph num="J.">
    <text>Department Oversight.</text>
    <paragraph num="(1)">
      <text>The hospital shall comply with all data reporting requirements of the Maryland Health Care Commission related to the prevention and acquisition of infections in accordance with Health-General Article, §19-134(e), Annotated Code of Maryland.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The Department shall have access to all data maintained through the hospital's infection prevention and control program to determine the hospital's compliance with State and federal regulations.</text>
    </paragraph>
  </paragraph>
</regulation>