1. Introduction

1.1 Definition: Infection Control encompasses the policies, procedures and practices used to prevent the spread of infectious disease during the delivery of healthcare services, and includes a broad range of activities such as sterilization and disinfection practices; isolation precautions; use of protective equipment; procedures for handling infectious materials, devices or equipment; reporting of communicable diseases to local health agencies; recognizing and investigating facility-related outbreaks and clusters; maintaining an interface with state and local Health Departments.

1.2 Purpose To ensure that appropriate Infection Control practices are followed in ECU healthcare clinical facilities to protect employees, patients, visitors and students from acquisition and spread of infection during healthcare contacts and to comply with state and federal regulations governing healthcare facilities and communicable diseases.

1.2.1 To ensure university compliance with OSHA regulations on blood borne pathogens and tuberculosis in all settings.

2. Scope:

2.1. All University clinical facilities or units which perform invasive procedures on humans are subject to the specific Infection Control requirements promulgated by NC Administrative Code and to federal OSHA regulations. CDC Guidelines are a national standard of care used to guide practice when formal regulations are absent.

2.1.1. North Carolina Administrative Code defines invasive procedures as entry into tissue, cavities or organs or repair of traumatic injuries. This includes surgical and dental procedures with potential for bleeding, vaginal or cesarian deliveries and also the use of needles to puncture skin, i.e., giving inoculations.

2.2. The Infection Control regulations apply to all faculty, staff or students and visitors who are involved in healthcare or are exposed to certain Infectious hazards transmissible among humans during their work or curricular activities.

2.3. The Infection Control regulations apply to all facilities owned, occupied or leased by the University.

2.4. Those facilities or units which are not strictly ,healthcareŠ or ,clinicalŠ but which conduct equivalent activities or processes, or involve situations in which personnel encounter potentially infectious materials (e.g. human blood, body fluid or unfixed tissue) in the course of their work are also subject to selected relevant Infection Control requirements (e.g., Police, Exercise and Sports Science, Housekeeping).

2.5. Infection Control requirements apply to operations in clinical laboratories using human materials. Such laboratories are also subject to Biosafety requirements if infectious agents or recombinant materials are used.

2.5.1. In general, faculty, staff or students, who encounter such potentially infectious human materials in the academic setting (research or teaching laboratories) will be subject to equivalent protections under the Biological Safety requirements.

2.6. When faculty, staff, or students are assigned to work at other institutions (occupational or curricular assignment), the University Infection Control practices will be followed, but may be supplemented by or coordinated with site-specific local institutional practices.

3. Responsibilities

3.1. All faculty, staff, students and visitors will comply with the University-wide regulations and with their unit specific Standard Operating Procedures.

3.1.1. The department chairs and/or supervisors are responsible for ensuring compliance with the Infection Control regulations and the SOP‰s applicable to their areas and employees.

3.1.2. Infection Control will provide guidance, advice and recommendations to facilitate development and implementation of the regulations and SOP‰s.

3.2. If a situation immediately dangerous to life or health in a healthcare facility is detected, Infection Control may consult with Infectious Disease and/or notify administration or Public Health authorities to address the issue ASAP.

4. The Infection Control Program is comprised of the Infection Control Nurse, and support colleagues in the Office of Prospective Health, and the ECU Infection Control Committee

4.1. The Infection Control Nurse and support colleagues in Office of Prospective Health are responsible on a day-to-day basis for ensuring that ECU clinical facilities comply with these regulations; providing guidance and oversight, training, education and advice, inspection and consultation services to clinical areas; initiating or updating specific written regulations and guidelines; ensuring the development and implementation of unit-specific standard operating procedures; interfacing with clinical staff and regulatory agencies and local and State Health departments; conducting investigations of exposure or outbreak situations.

4.2. One local Infection Control contact will be designated in each clinic or unit and trained to serve as local expert.

4.2.1. Student Health Services operates an independent unit-specific Infection Control Program following the principles outlined in this regulation, under the guidance of University Infection Control. Providing independent tallies and summary reports to the Infection Control Committee at each meeting.

4.3. The ECU Infection Control Committee provides input and oversight to develop and implement Infection Control regulations, Standard Operating Procedures, plans and guidelines; reviews infectious diseases reports, clinic inspections, facility issues, investigation of outbreaks or other events, and makes recommendations for improvements or solving problems.

4.3.1. The Committee is chaired by an Infectious Disease physician

4.3.2. The Committee is comprised of members of clinical departments (faculty and staff) representing the entire campus and also includes representatives of Facilities Services and the hospital.

4.4. Infection Control measures include isolation of patients, cleaning and disinfection processes, use of personal protective equipment, engineering controls and facilities modifications, review of new construction/renovation designs and plans, evaluations of the healthcare environment and practices for possible infection control problems, or development of new administrative processes or training.

4.4.1. Preventive Immunizations and training constitute additional Infection Control operations.

4.4.2. Post-exposure clinical evaluations are conducted by the Office of Prospective Health under the Infection Control regulations.

5. Infection Control Manual

The manual consists of the detailed information and specific processes followed to implement the Infection Control regulations and standard operating procedures. Other content is posted in the Infection Control manual to support and supplement it.

5.1. The Infection Control regulations are applicable to the entire University.

These include the Bloodborne Pathogens Exposure Control plan, the Tuberculosis Exposure Control Plan and all other University regulations which relate to sanitation across all healthcare facilities and affected units, encompassing areas such as disinfection, sterilization, isolation and infection control practices, disposal of biomedical waste.

5.2. The Standard Operating Procedures are developed by each clinical department or unit. This site-specific Infection Control Standard Operating Procedure is developed by a clinical departmental or unit representative (typically the Nurse/Clinical Coordinator) using the Infection Control template to guide and standardize content. This document addresses anticipated Infection Control needs specific to the activities and procedures performed in the unit, serves as a training tool for new staff and guides clinic inspections performed by Infection Control.

5.3. Other content

5.3.1. Guidelines are documents issued by authoritative agencies addressing specific potential situations, posted in the manual for possible future reference accessible to all units.

5.3.2. Plans are local documents developed to address specific emerging infectious conditions in anticipation of a potential outbreak or epidemic. While the condition of concern may or may not materialize, the University makes contingency plans to prepare for that eventuality, and outline its response for ready action if needed.

5.4. The manual is updated as federal or state laws or national standards change, as new interpretations are issued, or at the intervals recommended or required by the governing regulatory or authoritative agency. The manual is posted on the ECU website for ready access of the most up-to-date version.

6. Reporting of Communicable Diseases

Responsibility to report certain Communicable Diseases under NCAC 130A-134 to 143 is assigned to the treating physician.

6.1. At the Brody School of Medicine, for Communicable Diseases which occur commonly and are reportable on a basis designated as ,routineŠ under N.C.A.C., this duty to report to the patient‰s local health department may be delegated to the Infection Control Nurse. This typically includes:

6.1.1. Diseases/individuals reported to Infection Control by the PCMH laboratory and

6.1.2. Diseases/individuals reported to Infection Control by the treating department.

6.2. The suspicion or recognition of a Communicable Disease designated as reportable ,ImmediatelyŠ under NC.A.C. should be reported directly to the Health Department by the treating physician. These rare and exotic conditions constitute Public Health emergencies.

6.3. Student Health Service reports the Communicable Diseases seen in their facility directly to the Health Department.