Hospital Respiratory Protection Program Toolkit Resources for Respirator Program Administrators Published in MAY 2015 (updated APRIL 2022)

U.S. Department of Labor

This document is in the public domain and may be freely copied or reprinted.

This document was originally adapted from a California-specific guide, Implementing Respiratory Protection Programs in Hospitals: A Guide for Respirator Program Administrators, May 2012, which was developed by the California Department of Public Health, Occupational Health Branch, and the Public Health Instituteunder contract no. 254-2010-345-11 from the National Institute for Occupational Safety and Health, National Personal Protective Technology Laboratory (NIOSH-NPPTL). The guide was adapted under contract no. 254-2011-M-40839 from NIOSH-NPPTL to produce this toolkit.

Since the original publication of this document in 2015, in this republished 2022 version, minor errors were corrected, hyperlinking practices were improved to follow more modern standards, and broken or outdated hyperlinks were fixed.

Special thanks to the following organizations for assistance in the development and/or review of these materials:

3M, Inc. Hospital Corporation Service Employees International of America Union (SEIU) America Federation of Labor-Congress of Industrial Illinois State University, University of Minnesota, School Organizations (AFL-CIO) Department of Health Sciences of Public Health

American Federation of Intermountain Healthcare University of North Carolina, State, County, and Municipal Chapel Hill Employees (AFSCME) Kaiser Permanente Veterans Health Arizona Division of Mayo Clinic Administration, Iowa City Occupational Safety and Health VA Health Care System Michigan Public Institute, Children’s Healthcare of Center for Healthy Communities Veterans Health Administration, Atlanta, Inc. Office of Public Health New York State Department Coalition of Kaiser of Health Y. Day Designs Permanente Unions

This guidance document is not a standard or regulation, and it creates no new legal obligations. It contains recommendations as well as descriptions of mandatory safety and health standards. The recommendations are advisory in nature, informational in content, and are intended to assist employers in providing a safe and healthful workplace. The Occupational Safety and Health Act requires employers to comply with safety and health standards and regulations promulgated by OSHA or by a state with an OSHA-approved state plan. In addition, the Act’s General Duty Clause, Section 5(a)(1), requires employers to provide their employees with a workplace free from recognized hazards likely to cause death or seriousphysical harm.

Cover photo courtesy of 3M. ©2015

Hospital Respiratory Protection Program Toolkit Resources for Respirator Program Administrators

APRIL 2022

U.S. Department of Labor

Table of Contents Abbreviations Used in the Toolkit ................................................................................................................ vii

Glossary ............................................................................................................................................................ viii

Introduction to This Toolkit.............................................................................................................................. 1

Why Hospitals Need a Respiratory Protection Program ............................................................................. 3

Respiratory Hazards in the Healthcare Setting ....................................................................................................... 3

Respiratory Protection Reduces Inhalation of Aerosols....................................................................................... 4

Multiple Approaches are Needed for Infection Prevention and Control....................................................... 7

The 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings ........................................................... 8 More Considerations About Respirator Use .......................................................................................................... 10

The OSHA Respiratory Protection Standard.......................................................................................................... 13

Types of Respiratory Protection .................................................................................................................... 15

Air-Purifying Respirators .............................................................................................................................................. 15

Air-Supplying Respirators ............................................................................................................................................ 17

Developing a Respiratory Protection Program .......................................................................................... 19

Assigning Responsibility .............................................................................................................................................. 19

Performing a Hazard Evaluation................................................................................................................................ 19

Developing Policies and Procedures ....................................................................................................................... 21

Summary ........................................................................................................................................................... 35

References, Resources, and Tools .................................................................................................................36

Regulatory Standards and Interpretations ............................................................................................................ 36

Healthcare Resources and Guidelines ..................................................................................................................... 36

General Respiratory Protection Resources ............................................................................................................ 38

Medical and Industrial Hygiene Services ............................................................................................................... 39

Administrative Resources ............................................................................................................................................ 39

Training and Educational Resources........................................................................................................................ 39

Appendix A ....................................................................................................................................................... 41

Clinical Syndromes or Conditions Warranting Empiric Transmission-Based Precautions Pending Confirmation of Diagnosis ....................................................... 41

Appendix B ....................................................................................................................................................... 43

OSHA Assigned Protection Factors .......................................................................................................................... 43

Appendix C ....................................................................................................................................................... 44

Respiratory Protection Program Evaluation Checklist and Instructions for Use ...................................................................................................... 44 RPP Evaluation Checklist Instructions ..................................................................................................................... 46

Appendix D ....................................................................................................................................................... 49

Respiratory Protection Program Template for Hospitals .................................................................................. 49

FIGURES 1 Examples of Methods for Controlling Exposure to Aerosol Transmissible Disease Pathogens ................................................................... 4 2 Surgical Masks, Filtering Facepiece Respirators, and Surgical Respirators ............................................................................... 6 3 CDC and HICPAC—Diseases/Pathogens Requiring Airborne Precautions ................. 9

4 CDC and HICPAC—Diseases/Pathogens Requiring Droplet Precautions......................................................................................... 11 5 Examples of Aerosol-Generating Procedures ................................................................ 12

6 Some Key Requirements of the OSHA Respiratory Protection Standard .................. 14

7 NIOSH Filter Classes ........................................................................................................... 17

8 Establishment of Policies Regarding Non-Employees ................................................. 21

9 Respiratory Protection Selection Guide for Aerosol Transmissible Diseases .................................................................................. 24 10 Summary of Respirator Selection Considerations for Aerosol Transmissible Disease Pathogens ..................................................................... 26 11 Summary of Fit Test Requirements........................................................................................ 31

Abbreviations Used in the Toolkit AIHA American Industrial Hygiene MERS-CoV Middle East Respiratory Association Syndrome coronavirus

AII airborne infection isolation MRSA methicillin-resistant Staphylococcus aureus AIIR airborne infection isolation room MSSA methicillin-susceptible APF assigned protection factor Staphylococcus aureus APR air-purifying respirator NIOSH National Institute for Occupational ATD aerosol transmissible disease Safety and Health

BMBL Biosafety in Microbiological and NPPTL National Personal Protective Biomedical Laboratories Technology Laboratory

Cal/OSHA California Department of OSHA Occupational Safety and Industrial Relations, Division of Health Administration Occupational Safety and Health PAPR powered air-purifying respirator CBRN chemical, biological, radiological, PLHCP physician or other licensed and nuclear healthcare professional CDC Centers for Disease Control PPE personal protective equipment and Prevention RPA respirator program administrator CNC condensation nuclei counter RPP respiratory protection program FDA Food and Drug Administration SARS severe acute respiratory syndrome HCP healthcare personnel SARS-CoV SARS-associated coronavirus HE high-efficiency SCBA self-contained breathing apparatus HEPA high-efficiency particulate air TB tuberculosis HICPAC Healthcare Infection Control Practices Advisory Committee VHF viral hemorrhagic fever

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HOSPITAL RESPIRATORY PROTECTION PROGRAM TOOLKIT Resources for Respirator Program Administrators

Glossary Aerosol-generating procedures— Air-purifying respirator (APR)—A respirator with Procedures that may increase potential exposure an air-purifying filter, cartridge, or canister that to aerosol transmissible disease pathogens due removes specific air contaminants by passing to the reasonably anticipated aerosolization ambient air through an air-purifying element. See of pathogens. Aerosol-generating procedures page 15 for a detailed explanation. may also be known as high-hazard or cough-inducing procedures. See page 12 for a Assigned protection factor (APF)—The workplace detailed explanation. level of respiratory protection that a respirator or class of respirators is expected to provide to Aerosol transmissible disease (ATD) or aerosol employees when the employer implements a transmissible disease pathogen—Any disease continuing, effective respiratory protection or pathogen requiring Airborne Precautions program as specified in 29 CFR 1910.134. and/or Droplet Precautions. Droplet Precautions—A category of Airborne infection isolation room (AIIR)—A Transmission-Based Precautions that CDC single-occupancy patient-care room designed and HICPAC may recommend when Standard to isolate persons with suspected or confirmed Precautions alone are not sufficient to airborne infectious diseases. Environmental prevent the transmission of disease. When factors are controlled in AIIRs to minimize the Droplet Precautions are required, patients transmissionof infectious agents that can be should be spatially separated, preferably in spread from person to person by the airborne separate roomswith closed doors. route. AIIRs should maintain negative pressure Healthcare personnel should wear surgical relative to adjacent rooms and halls (so that air masks for close contact and, if substantial flows under the door gap into the room), an spraying of body fluids is anticipated, gloves air flow rate of 6–12 air changes per hour, and and gowns as well as goggles (or face shields direct exhaust of air from the room to the in place of goggles). Patients should be outside of the building or recirculation of air masked during transport. through a HEPA filter. Facemask—A loose-fitting, disposable device that Airborne Precautions—A category of creates a physical barrier between the mouth and Transmission-Based Precautions that CDC nose of the wearer and potential contaminants in and HICPAC may recommend when Standard the immediate environment. Facemasks may be Precautions alone are not sufficient to labeled as surgical, laser, isolation, dental, or prevent the transmission of disease. When medical procedure masks and are cleared by the Airborne Precautions are required, patients FDA for marketing. They may come with or should be placed in airborne infection without a face shield. Facemasks do not seal isolation rooms and healthcare personnel tightly to the wearer’s face, do not provide the sharing patients’ airspacesshould wear wearer with a reliable level of protection from respirators. inhaling smaller airborne particles, and are not considered respiratory protection.

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Facepiece—The part of a respirator that covers Healthcare personnel (HCP)—Paid and unpaid the nose and mouth of the wearer. Respirators persons who provide patient care in a healthcare may have half facepieces covering just the nose setting or support the delivery of healthcare by and mouth, or they may have full facepieces providing clerical, dietary, housekeeping, covering the nose, mouth, and eyes. They are engineering, security, or maintenance services. designed to form a seal with the face. High-efficiency (HE) or high-efficiency particulate Filtering facepiece respirator—A disposable air (HEPA) filter—The NIOSH classification for a (single-use), negative-pressure, air-purifying filter that is at least 99.97% efficient in removing respirator where an integral part or all of the particles and is used in powered air-purifying facepiece is made of filtering material. respirators (PAPRs). When high-efficiency filters are required for non-powered respirators, N100, R100, Fit factor—A quantitative estimate of the fit ofa or P100 filters may be used. particular respirator to a specific individual; typically estimates the ratio of the concentration Hood—The portion of a respirator that of a substance in ambient air to its concentration completely covers the head and neck, and may inside the respirator when worn. also cover portions of the shoulders and torso, and through which clean air is distributed to the Fit test—The use of a protocol to qualitatively or breathing zone. quantitatively evaluate the fit of a respirator on an individual. Loose-fitting facepiece—The portion of a respirator that forms a partial seal with the Food and Drug Administration (FDA)—An face but leaves the back of the neck exposed, agency within the U.S. Department of Health and is designed to form a partial seal with the face, Human Services. The FDA is responsible for, and through which clean air is distributed to among other things, protecting the public health the breathing zone. by assuring drugs, vaccines, and other biological products and medical devices intended for N95 filter—A type of NIOSH-approved filter or human use are safe and effective. filter material, which captures at least 95% of airborne particles and is not resistant to oil. Healthcare Infection Control Practices Advisory Committee (HICPAC)—A federal advisory N95 respirator—A generally used term for committee assembled to provide guidance to a half mask air-purifying respirator with CDC and the U.S. Department of Health and NIOSH-approved N95 particulate filters or filter Human Services on the practice of infection material (i.e., includes a N95 filtering facepiece control and strategies for surveillance, prevention, respirator or equivalent protection). and control of healthcare-associated infections and Negative-pressure respirator—A tight-fitting antimicrobial resistance in United States respirator in which air is inhaled through an healthcare settings. CDC and HICPAC authored air-purifying filter, cartridge, or canister during the 2007 Guideline for Isolation Precautions: inhalational efforts, generating negative Preventing Transmission of Infectious Agents in pressure inside the facepiece relative to Healthcare Settings, which describes Standard and ambient air pressure outside the respirator. Transmission-Based Precautions used for infection control.

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HOSPITAL RESPIRATORY PROTECTION PROGRAM TOOLKIT Resources for Respirator Program Administrators

Personal protective equipment (PPE)— Respirator program administrator (RPA)— Specialized clothing or equipment worn by an Individual designated to oversee a facility’s employee to protect the respiratory tract, mucous respiratory protection program (RPP). membranes, skin, and clothing from infectious agents or other hazards. Examples of PPE include Respiratory protection program (RPP)— gloves, respirators, goggles, facemasks, surgical Program required by OSHA under the Respiratory masks, faceshields, footwear, and gowns. Protection standard that includes development and implementation of detailed policies and Physician or other licensed healthcare worksite-specific procedures for respirator use for professional (PLHCP)—An individual whose control of respiratory hazards. legally permitted scope of practice (i.e., license, registration, or certification), as defined by the Surgical mask—A loose-fitting, disposable state where he or she practices, allows him or type of facemask that creates a physical barrier her to independently provide, or be delegated between the mouth and nose of the wearer the responsibility to provide, some or all of the and potential contaminants in the immediate healthcare services required to provide a environment. Surgical masks are fluid-resistant medical evaluation as described in OSHA’s and provide protection from splashes, sprays, Respiratory Protection standard. and splatter. Surgical masks do not seal tightly to the wearer’s face, do not provide the wearer Powered air-purifying respirator (PAPR)—An with a reliable level of protection from inhaling air-purifying respirator that uses a blower to smaller airborne particles, and are not force air through filters or cartridges and into considered respiratory protection. the breathing zone of the wearer. This creates a positive pressure inside the facepiece or hood, Surgical respirator—A filtering facepiece providing more protection than a non-powered respirator with spray- or splash-resistant or negative-pressure half mask APR. facemask material on the outside to protect the wearer from splashes. Also known as a surgical Qualitative fit testing (QLFT)—A pass/fail fit test N95 respirator. to assess the adequacy of respirator fit that relies on the individual’s response to a test agent. User seal check—An action conducted by the respirator user to determine if the respirator is Quantitative fit testing (QNFT)— properly seated to the face. For all tight-fitting An assessment of the adequacy of respirator fit respirators, the employer shall ensure that by numerically measuring the amount of leakage employees perform a user seal check each time into the respirator. they put on the respirator using the procedures in Appendix B-1 of OSHA’s Respiratory Protection Respirator—A device worn over the nose and standard or equally effective procedures mouth to protect the wearer from hazardous recommended by the respirator manufacturer. materials in the wearer’s breathing zone. However, user seal checks are not substitutes for Respirators must be certified by NIOSH for the qualitative or quantitative fit tests. purpose for which they are used.

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Introduction to This Toolkit This toolkit was developed to assist hospitals in developing and implementing effective respiratory protection programs, with an emphasis on preventing the transmission of aerosol transmissible diseases (ATDs) to healthcare personnel. Healthcare personnel are paid and unpaid persons who provide patient care in a healthcare setting or support the delivery of healthcare by providing clerical, dietary, housekeeping, engineering, security, or maintenance services. Healthcare personnel may potentially be exposed to ATD pathogens. Aerosols are particles or droplets suspended in air. ATDs are diseases transmitted when infectious agents, which are suspended or present in particles or droplets, contact the mucous membranes or are inhaled.

Hospitals are unique work environments Photo: 3M

with challenging occupational health and safety issues. Some hospitals have health and safety personnel who are highly qualified to develop and implement appropriate policies and procedures to control workplace exposures. However, in many facilities with

Photo: Haylard Health, Inc. more limited resources, the role of the health and safety professional might be taken on as an added responsibility by someone in the nursing, employee health, or infection control department. This toolkit is written as a practical manual that can be Filtering facepiece respirators being used in used by anyone charged with setting up and healthcare workplaces. maintaining a hospital respiratory protection program. A respirator is a device worn over the nose and mouth to protect the wearer from hazardous materials in the breathing zone.

HOSPITAL RESPIRATORY PROTECTION PROGRAM TOOLKIT Resources for Respirator Program Administrators

In healthcare, the term respirator is also used this document, but we have also collected many to describe a mechanical ventilator that helps more that were produced by other organizations patients who are having difficulty breathing; and are available on the Internet. this document does not address this type of medical equipment. This toolkit identifies existing public health guidance where available on the use of The body and appendices of the toolkit include respiratory protection. Scientific evidence is links to references, educational resources, and continuously evolving, particularly with regard electronic tools such as templates, sample forms, to disease transmission. Precautionary use of and educational materials. Some of the tools respiratory protection may be prudent where and resources were developed by the authors of scientific uncertainty exists.

Why Hospitals Need a Respiratory Protection Program

Respiratory Hazards in the fungi) cannot be eliminated from or substituted out of the hospital setting. ATD pathogen Healthcare Setting exposures cannot routinely be measured in the air and have no established occupational The hospital environment contains hazards exposure limits. In addition, ATD pathogens such as bacteria, viruses, and chemicals that vary in infectivity and severity of outcome. In may be inhaled by personnel and cause injury order to protect employees from ATDs, or illness. The approach for reducing exposure healthcare facilities must implement required by the Occupational Safety and Health comprehensive infection control plans using a Administration (OSHA) and accepted by health combination of engineering, administrative and safety professionals is to use a “hierarchy of (including training and vaccination), and work controls.” This means we start with the most practice controls, and provide for the use of effective controls—the elimination of hazards respirators and other PPE. or substitution of less hazardous processes, chemicals, or products. Next in the hierarchy Healthcare personnel who care for patients with are engineering controls, which involve ATDs must work in close proximity to the source isolating the hazard and/or using specialized of the hazard; even with controls in place, they are ventilation (e.g., isolation rooms or laboratory likely to have a higher risk of inhaling infectious hoods). Where these controls are not feasible or aerosols (droplets and particles) than the general adequate, administrative controls (e.g., public. These personnel, and others with a higher providing vaccinations or triaging chemical risk of exposure related to the tasks they perform emergency patients) and work practices (e.g., (e.g., lab or autopsy workers), must often be following respiratory hygiene/cough etiquette protected further through the proper use of strategies or keeping chemical containers capped) are used to reduce risk, most often by

Photo: Centers for Disease Control and Prevention minimizing the extent or duration of the exposure, or by reducing the number of employees exposed. Respirators and other personal protective equipment (PPE) are used as a last line of defense when exposurescannot be reduced to an acceptable level using these other methods. Each facility should develop policies and