Document ID: OSHA-2010-0003-0244
Agency: osha
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-10-09T04:00Z

Outline of Key Provisions in OSHA's Infectious Diseases
                             Regulatory Framework

This outline of the infectious diseases regulatory framework does not address every provision completely; the infectious diseases regulatory framework should be consulted for the complete description of all requirements.
                                       
Section 1: Scope 
This section delineates worker tasks being considered for coverage.
Occupational exposure of workers to contact, droplet, or airborne transmissible infectious agents during provision of direct patient care or performance of other covered tasks would be covered.  

Section 2: Definitions
This section explains the Agency's intended meaning of terms used in the body of the regulatory framework, including:
   * Occupational exposure means exposure, which is or should be reasonably anticipated, to sources of infectious agents resulting from an employee's execution of job duties that involve the provision of direct patient care or the performance of other covered tasks.
   * Direct patient care generally includes job duties that involve the provision of healthcare services with hands-on or face-to-face contact with patients, but does not include job duties of employees who perform first aid only (see regulatory framework for full definition).
   * Other covered tasks include job duties that do not involve direct patient care but still involve occupational exposure in four settings: (1) where direct patient care is provided, (2) where there are contaminated materials originating from settings where direct patient care is provided (3) where there is exposure to human remains, and (4) in diagnostic, research or production facilities where there is exposure to contaminated materials (see regulatory framework for full definition).    

Section 3: Worker Infection Control Plan (WICP)  
This section provides an overall framework for an infection control plan that all affected employers would be required to develop.  
   * Ensure the WICP is a written plan.
   * Prepare an exposure determination.
   * Have a WICP that contains at least the following elements: 
         o          Designated plan administrator responsible for implementation and oversight of the WICP; 
         o          Name of person(s) responsible for daily management of the WICP; 
         o          Exposure determination; and 
         o          Standard operating procedures (SOPs) for infection control measures. 
   * Make a copy of the WICP accessible to workers.  The WICP could be part of a larger document.
   * Review/update the WICP at least annually, and when necessary if there are changes in exposure due to:  
         o          New or modified job tasks and procedures; 
         o          New or revised job classifications;
         o          Changes in technology; and 
         o          New or emerging infectious agents or changes in community patterns of infectious diseases (e.g., emergence of an antibiotic resistant infectious agent, an outbreak or a change in prevalence of an infectious disease). 
      *       During development and reviews of the WICP:
         o          Solicit input from non-managerial workers with occupational exposure; 
         o          Establish and maintain records for each review and/or update of the WICP.
      *       Host employers  -  
         o          Ensure that contractors, vendors, and licensed independent practitioners with privileges adhere to infection control practices consistent with, or more protective than, the host employer's WICP.
         o          Ensure that the WICP is followed by employees (but see exception noted in regulatory framework).
         o          Ensure a copy of the WICP is provided and accessible to contractors, vendors, and licensed independent practitioners with privileges.
         o          Note:  Employers that are contractors, vendors, and licensed independent practitioners with privileges would also be obligated to comply with all components of regulatory framework.
      *       Ensure the WICP is available to the Assistant Secretary upon request.

Section 4: Standard Operating Procedures Development and Implementation
This section describes the general considerations and sources that employers would be required to consider in developing their SOPs.  In addition, this section provides a list of SOPs that employers in all affected work settings would be required to develop as part of their WICPs, and specific SOPs that employers with workers that provide direct patient care or workers that perform other covered tasks would be required to develop.  
General considerations.  In general, develop SOPs consistent with recognized and generally accepted good infection control practices.  In developing SOPs, consider applicable regulations and guidelines.  
   In all work settings, have, and ensure employees follow, SOPs for:

   * Infectious agent hazard evaluations, which would not need to be written if incorporated into routine activities, such as triage.
   * Communicating hazard evaluation results to responsible person(s);
   * Hand hygiene; 
   * Restricting some activities (e.g., eating and drinking) where occupational exposure could occur; 
   * Using engineering, administrative and work practice controls, and personal protective equipment (PPE); 
         o          Ensure controls are used in accordance with recognized and generally accepted good infection control practices;
         o          Provide access to, and ensure proper use of, PPE; 
         o          Develop regular schedule for inspecting, maintaining, and replacing engineering controls; and 
         o          Ensure procedures are performed in a manner that prevents or minimizes the generation/transmission of infectious agents.
Note: OSHA would permit the required hierarchy of controls to be modified in accordance with recognized and generally accepted good infection control practices.
   * Decontamination;
         o          Provide for the routine and targeted decontamination of all contaminated materials (i.e., contaminated items and/or surfaces) in the work setting;
         o          Inspect and decontaminate equipment prior to servicing or shipping.
   * Handling, containerization, transport, or disposal of contaminated materials;
         o          Place contaminated materials in appropriate containers that are labeled/color-coded and leak proof; 
         o          Minimize or prevent employee contact with contaminated materials.
   * Occupational health services, including vaccinations, post-exposure treatment, and medical removal protection;
   * Investigating exposure incidents;
   * Using appropriate signage and labeling/color-coding; and  
   * Notifying other employers of occupational exposure during transfer, transport, shipping, or receipt of infectious agent sources.

   Direct patient care settings  -  in addition to SOPs developed for all work settings, have, and ensure employees follow, SOPs for:

   * Patient scheduling and intake/admittance;
   * Standard precautions;
   * Contact precautions; 
   * Droplet precautions;
   * Airborne precautions, including where applicable, procedures for:
         o          If the employer does not have an airborne infection isolation room (AIIR), use of temporary isolation and inter-facility transfer of infectious individuals;
         o          If the employer has an AIIR, ensuring proper AIIR operation;
         o          Respiratory protection.
   * Patient transport;
   * Medical surge procedures;
   * Any other worker protection precautions necessary to address specific circumstances.

   Employers with employees who perform other covered tasks  -  in addition to SOPs developed for all work settings, have, and ensure employees follow, SOPs for:

   * Handling and intake of contaminated materials;
   * Implementing control measures to prevent or minimize transmission of infectious agents;
   * In diagnostic, research, and production facilities, implementing standard microbiological practices and any special practices for handling infectious agents, including:
         o          Engineering controls properly constructed, operated and maintained;
         o          Measures necessary to address uncontrolled releases of infectious agents.
   * Any other worker protection precautions necessary to address specific circumstances.
   
Section 5: Medical surveillance and vaccination 
This section specifies, among other things, the medical screening, surveillance and vaccinations that would be required to be provided to workers who have occupational exposure, and the procedures that would be required to be followed after an exposure incident.
      *       General.  
   o          Make available medical screening, surveillance and vaccinations to workers with occupational exposure, and post-exposure evaluation and follow-up for each employee who has had an exposure incident.
   o          Ensure all medical evaluations and procedures are performed by or under supervision of a physician or other licensed healthcare professional (PLHCP) and that lab tests are conducted by accredited laboratories.
      *       Vaccinations. 
   o          Make available all appropriate vaccinations consistent with recognized and generally accepted good infection control practices;
   o          In a facility other than a research and production facility, make available the following vaccinations: influenza, MMR, Tdap, Varicella and any other vaccination specified in the employer's WICP or determined to be medically appropriate by a PLHCP; 
   o          Review and update vaccinations specified in the WICP at least annually and when necessary to reflect changes in exposure; 
   o          Exception:  vaccinations would not need to be made available to an employee who has immunity or where the vaccine is contraindicated;
   o          Monitor vaccination series until complete;
   o          Make vaccinations available after training and prior to initial assignment to a job with occupational exposure;
   o          Ensure worker signs declination statement if vaccination(s) declined, and make vaccination available later if worker decides to accept it;
   o          Make available revaccinations or boosters in accordance with recognized and generally accepted good infection control practices.
   * Medical screening and surveillance. 
   * Medical evaluation and follow-up.  
   * Establish and maintain exposure incident records.
   * Provide information to PLHCP, including description of exposed employee's job duties. 
   * Obtain and provide to employee a copy of the PLHCP's written opinion within 15 days of the completion of the evaluation.  
   * Medical removal protection. 
   o          Employee restrictions or removal based on PLHCP's recommendation.
   o          Medical removal protection benefits: pay employee's total normal earnings and maintain employee's seniority and other rights and benefits (except generally in cases of the common cold or influenza). 
   * Establish and maintain medical records for each worker with occupational exposure.
   * Ensure the confidentiality of employee medical records.

Section 6: Training 
This section specifies the types and periods of training that employers would be required to provide to workers with occupational exposure to infectious agents.
   * Information and training: Prior to initial assignment; at least annually thereafter and whenever deemed necessary to address deficiencies. 
   * Training program: conducted by knowledgeable person; material appropriate for worker's education level and language; opportunity for interactive worker questions.
   * Initial training program: contains a copy of the standard; explanation of its contents; and appropriate explanation of WICP, SOPs, control measures, PPE, and vaccines (for other potential elements, see regulatory framework). 
   * Annual training elements: information on PPE; SOPs applicable to worker; information on vaccines. 

Section 7:  Recordkeeping 
This section specifies the types of records that would be required to be retained by the employer, the retention period that would be required for each record, and the employer's potential obligation to make certain records available to the worker and OSHA upon request.
   * Record maintenance.
   o          Maintain medical records for duration of employment + 30 years;
   o          Maintain exposure incident records for duration of employment + 30 years; and
   o          Maintain WICP review records for 3 years. 
   * Make exposure incident records, the WICP, and WICP review records available to workers or their representatives; make medical records available to the worker or to anyone having written consent of the worker; and make all records available to the Assistant Secretary upon request. 

Section 8: Cost and Availability
This section specifies that costs incurred by employee(s) would be compensable and that any activities that would be required of employees be conducted at a reasonable time and place. 
   * Implement the provisions of the regulatory framework at no cost to the employee; any time spent by employees to comply is considered compensable time.
   * Make medical evaluations and procedures and training available at reasonable times and places.

Appendices
Appendix A.  Common Infectious Diseases/Conditions/Agents and Their Modes of Transmission in Healthcare Settings (non-mandatory)
Appendix B.  Vaccine Declination (mandatory)