March 05, 2020

N95 Respirators: Following 5 OSHA Requirements

OSHA has a Respiratory Protection Standard that deals with respirators just as it has a Bloodborne Pathogens Standard that deals with exposure to blood and certain other body fluids. The N95 is the basic workhorse for healthcare applications for airborne biological pathogens. N95s differ from masks, because N95s are designed to seal tightly against the user’s face, while masks are not so designed. The Respiratory Protection Standard requires the following whenever the use of N95s is required:

  1. Written Respiratory Protection Program (RPP)
  2. Qualified Administrator
  3. Medical Clearance for employees to wear an N95
  4. Annual Fit Testing
  5. Annual Training

This paper provides a roadmap to how to comply with those five requirements.

What is a Filtering Facepiece Particulate Respirator?

  • An N95 is what is known as a filtering facepiece particulate respirator.
    • 3 filter efficiencies and 3 levels of oil resistance means that there are nine different types of filtering facepiece particulate respirators.
    • An N95, therefore, is a filtering facepiece particulate respirator that is 95% effective and is not oil resistant.
    • There are 3 levels of filter efficiency for filtering facepiece particulate respirators:
      • 95%
      • 99%
      • 99.97%
    • There are 3 levels of oil resistance for filtering facepiece particulate respirators:
      • N for non-oil resistant
      • R for oil resistant
      • P for oilproof
    • Another variation is what is called a Surgical N95, which is an N95 that also provides a physical barrier for large droplets of blood and other body fluids.
  • Keep in mind that an N95 is a particulate respirator; it does not offer protection from vapors such as formaldehyde, etc. The Small Entity Compliance Guide (see below) discusses the various types of respirators needed for protection from vapors.
  • There are many other types of respirators that offer protection, but they are higher in cost and require more detailed training and fit testing. For aerosol generating procedures on patients known or suspected to have aerosol transmissible diseases, for example, the California Aerosol Transmissible Diseases Standard requires Powered Air Purifying Respirators (PAPRs) be used.

How can you comply with each of OSHA’s five requirements?

Written Respiratory Protection Program

  • OSHA provides a template for creating a written RPP in the Small Entity Compliance Guide.
  • CDC provides another template in its Respiratory Protection Toolkit.
  • An edited and modified version of the CDC document, applicable only to N95 respirators, and suitable for use for non-hospital applications, has been prepared and is available from Stericycle.

Qualified Administrator (QA)

  • A person can become a QA for N95s just by reading the resources mentioned below, paying attention to the information relating to N95s. No formal training or certification is required. The QA needs to understand three things:
    • Respiratory hazards for which N95s would be appropriate
    • Protection from respiratory hazards provided by N95 Respirators
    • Requirements of the Respiratory Protection Standard as it applies to N95s.

Medical Clearance

  • Whenever respirators of any kind are required, medical clearance for a person to wear the respirator must be obtained beforehand. N95s are no exception.
  • Obtaining this clearance may require a medical exam, but generally, review of the OSHA questionnaire by a healthcare professional is all that is required.
    • OSHA provides the questionnaire to be used in Appendix C to the Respiratory Protection Standard. A copy is also available from Stericycle.
    • The employer provides a copy of the questionnaire for the employee to fill out, but the completed questionnaire is NOT shared with the employer. It is a confidential document. It is shared only with the healthcare professional who will review it and decide whether or not an actual physical exam is necessary.
    • The employer is informed by the healthcare professional simply as to whether or not the individual is cleared to wear an N95 based upon the information provided in the questionnaire.
  • Medical clearance is not an annual requirement. It is obtained before a person is permitted to wear the required N95 respirator and is not repeated unless there is some change that requires it.

    Annual Fit Testing

    • Is fit testing really required for N95s? The answer is yes. Whenever N95s are required, then the full requirements of the Respiratory Protection Standard are triggered, including initial and annual fit testing even for N95 respirators.
    • You may choose to send your employees to outside organizations capable of offering fit testing, or you may choose to learn to do it in-house. Materials needed for conducting fit testing are available from N95 respirator manufacturers and suppliers. And certain respirator manufacturers provide excellent videos on YouTube that show how to fit test N95 respirators.
    • Please refer to the video resources mentioned below under Annual Training for full instruction on performing fit testing for N95s.

    Annual Training

    • Training on N95s must be provided before a person wears a required N95.
    • Training must be provided yearly thereafter.
    • Training must cover
      • the requirements of the Respiratory Protection Standard as it applies to N95s,
      • limits of N95s (not for vapors, etc.),
      • how to properly put on an N95,
      • how to properly remove an N95,
      • how to perform user seal tests of the N95 each time an N95 is put on, etc.
    • Everything you need for training is readily available online at no charge.

    What about Voluntary Use?

    • Q: What if N95s for a particular use or application are not specifically required by OSHA or recommended by CDC, but an individual simply chooses to wear an N95 anyway?
    • A: In such a situation, an N95 is the only respirator that OSHA will permit a worker to wear on such a voluntary basis without first obtaining medical clearance.

    OSHA does, however, require the employer, in such situations, to provide the worker with a copy of Appendix D to the Respiratory Protection Standard.  A copy of Appendix D is available from Stericycle. Be aware, however, that when respirator use is required, employers cannot use the voluntary exception to avoid developing a written respiratory protection program, appointing a qualified administrator, obtaining medical clearance for employees who will use the respirators, or providing annual training and annual fit testing.

    Resources are available to help you achieve compliance

    • CDC provides a resource, the Hospital Respiratory Protection Program Toolkit (HRPPT), that deals with the use of respirators in hospitals specifically at www.cdc.gov/niosh/docs/2015-117/pdfs/2015-117.pdf?id=10.26616/NIOSHPUB2015117
    • OSHA provides another thorough resource in a document called the Small Entity Compliance Guide to the Respiratory Protection Standard (SECG) at https://www.osha.gov/Publications/3384small-entity-for-respiratory-protection-standard-rev.pdf. At first glance this document can appear daunting, but much of it deals with higher level respirators, and only a few pages are applicable to N95s.
    • In addition, both OSHA and CDC have online videos available on YouTube that deal with N95s.

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