The Occupational Health and Safety Administration’s (OSHA’s) Respiratory Protection Standard 29 CFR 1910.134 Healthcare, Public Health and Public Safety Settings Minnesota Department of Health

OSHA Respiratory Protection Standard 29 CFR 1910.134 This slide set focuses on airborne infectious disease hazards in healthcare, public health, and public safety settings that may be mitigated by respiratory protection This slide set is not meant to be a full summary of OSHA’s Respiratory Protection Standard 29 CFR 1910.134

How do healthcare and public safety settings differ from industrial settings? Diversity of job titles and duties Unique “business” of caring for the ill Societal behaviors related to caregiving role Exotic and unique exposures Suspension of usual self protection behaviors Emphasis on confidentiality

Possible Airborne Infectious Disease Exposures in Healthcare and Public Safety Settings Tuberculosis Influenza: seasonal, pandemic, avian Pertussis (whopping cough) SARS Smallpox Measles Varicella (chickenpox)

Hierarchy of Control Technologies Technologies that can mitigate exposure to a hazard The order in which these elements are selected to control exposure is important: engineering controls administrative and work practice controls personal protective equipment/apparel

Engineering Controls Physically separate the employee from the hazard Do not require direct employee compliance for efficacy Example: airborne infection isolation rooms for patients with known or suspect airborne infectious diseases

Airborne Infection Isolation Rooms Monitored negative air pressure in relation to the surrounding areas 6 to 12 air changes per hour Appropriate discharge of air outdoors or monitored high-efficiency filtration of room air before the air is circulated to other areas in the hospital Door that closes (and is kept closed)

Administrative Controls/Work Practices Policies, procedures, and programs that minimize the intensity or duration of exposure Standard procedures/behaviors in caring for patients, i.e., hand hygiene Example: placing a sign on the door of an airborne infection isolation room

Why is Respiratory Protection Necessary? Engineering or administrative controls are not always possible: Confinement of infectious agent may be difficult or impossible Improved ventilation may not be practical or feasible

Personal Protective Equipment Lowest rung of hierarchy – requires employee compliance for efficacy Means higher elements of hierarchy fail to adequately protect employee May involve use of gowns, gloves, eye/splash protection or respirators

Reasons for Respiratory Protection Employees may be exposed to a wide variety of air contaminants infectious agents chemical agents Engineering controls may not be feasible

Respiratory Protection (continued) Employees must wear respirators in the following circumstances: When employees enter rooms housing patients with suspected or confirmed airborne infectious disease When employees perform high hazard procedures on persons who have suspected or confirmed airborne infectious disease When emergency response employees or others must transport in a closed vehicle, a patient with suspected or confirmed airborne infectious disease

Airborne Infectious Disease Transmission Occurs by dissemination of airborne droplet nuclei -small particle residue (5 micron or smaller in size) of evaporated droplets containing microorganisms that remain suspended in the air for long periods of time or dust particles containing the infectious agent Microorganisms carried in this manner can be dispersed widely by air currents and may become inhaled by a susceptible host within the same room or over a longer distance from the source patient, depending on environmental factors

OSHA Standards for Respiratory Protection 1910.134 General industry standard: protect health of employees from harmful dusts, fogs, fumes, mists, gases, smokes, sprays, or vapors 1910.139 Applies only to respiratory protection for M. tuberculosis (withdrawn 12/31/2003, with grace period for implementation until July 1, 2004)

Respiratory Protection Standard 1910.134 Applies to all occupational airborne exposures to contaminated air when the employee is: exposed to a hazardous level of an airborne contaminant required by the employer to wear a respirator, or permitted to wear a respirator

Organization of Standard (a) Permissible practice (b) Definitions (c) Respirator program (d) Selection of respirators (e) Medical evaluation (f) Fit testing (g) Use of respirators (h) Maintenance and care (i) Breathing air quality and use Identification of filters, cartridges, and canisters Training and information (l) Program evaluation (m) Recordkeeping (n) Dates (o) Appendices (mandatory) A: Fit testing procedures B-1: User seal checks B-2: Cleaning procedures C: Medical questionnaire D: Information for employees wearing respirators when not required under the standard

OSHA’s Respiratory Protection Standard, continued Four major duties are imposed by the standard: Use engineering controls where feasible to control the hazard; Provide an appropriate respirator Ensure the use of an appropriate respirator, and Institute a respiratory protection program

Respiratory Protection Respirators are to be provided by the employer when such: equipment is necessary to protect the health of the employee equipment is applicable and suitable for the purpose intended The establishment and maintenance of the respiratory protection program is the responsibility of the employer

Personal respiratory protection should be used by: Employees entering areas where patients with suspected or confirmed airborne infectious disease are being isolated Employees present when cough-inducing or aerosol-generating procedures are performed on such patients Employees in other settings where administrative and engineering controls are not likely to protect them from inhaling infectious airborne droplet nuclei; these other settings should be identified on the basis of risk assessment

Components of Respiratory Protection Program Risk Assessment Selection of respirators Standard operating procedures Medical screening Training Fit testing Maintenance Evaluation Good Program= Compliance

Step 1 – Risk Assessment Conducting a risk assessment: What is the likelihood of employee exposure to an airborne infectious disease? Can exposure to an airborne infectious disease reasonably be anticipated? Risk assessment for tuberculosis includes evaluating annual tuberculosis data from the Minnesota Department of Health

Step 2 – Select Respirators Based on risk assessment: evaluate the respiratory hazards look at any other relevant factors select the “right” respirator Any respirator selected must be NIOSH-certified

Classes of Filters Filters are classified by efficiency and performance characteristics against non-oil and oil-containing hazards There are nine classes of filters (three levels of filter efficiency, each with three categories of resistance to filter efficiency degradation) Levels of filter efficiency are 95%, 99%, and 99.97% Categories of resistance to filter efficiency degradation are labeled N, R, and P Use of the filter will be clearly marked on the filter, filter package, or respirator box (e.g., N95 means N-series filter at least 95% efficient)

Filter Efficiency Under NIOSH criteria, filter materials are tested at a flow rate of 85 lpm for penetration by particles with a medial aerodynamic diameter of 0.3 um (the most difficult size to filter) and if certified are placed in one of the following categories: Type 100 (99.7% efficient) Type 99 (99% efficient) Type 95 (95% efficient)

Infectious Particles Particles greater than 5 microns fall out of the air Particles 1 – 5 microns in diameter can enter upper airways 0.1 – 1 micron particles enter lower lungs and alveolar ducts

Particulate Filters Efficiency based on ability to remove particles greater than 0.3 microns in diameter Rating of 95%, 97%, 99.97% efficiency Examples of particle size: Viruses 0.02 – 0.3 microns Bacteria 0.5 – 10 microns Mold spores 1 – 70 microns Fungi 2 - >200 microns

Types of Respirators Used in Healthcare Settings PAPR N95 Respirators Powered Air Purifying Respirator

Surgical Mask vs. N95 Respirator The primary design purpose of a surgical mask is to filter or redirect particles expelled by the wearer The filter material of surgical masks may not prevent penetration of sub-micron aerosols Surgical masks are not necessarily designed to seal tightly to the face, therefore the potential for air leakage around the edges exists A respirator is designed to reduce the exposure of the wearer to airborne hazards and can filter sub-micron aerosols

Respirator Limitations All respirators have limitations: Improper fit Improper donning Damage Contamination

Step 3 – Write Standard Operating Procedures (SOPs) Hospitals must develop and implement a written respiratory protection program Program must be administered by a “suitably trained” program administrator

Step 4 – Medical Screening “Employer shall provide a medical evaluation to determine the employee’s ability to use a respirator, before the employee is fit tested or required to use the respirator in the workplace” OSHA’s respirator medical evaluation questionnaire is mandatory and must be performed prior to fit testing

Minimum Requirement For Medical Evaluation A physician or other licensed healthcare professional must perform the medical evaluation using: OSHA’s respirator medical evaluation questionnaire, or an initial medical exam that obtains the same information as the OSHA questionnaire

Physician or Other Licensed Health Care Professional “An individual whose legally permitted scope of practice (i.e., license, registration, or certification) allows him/her to independently provide, or be delegated the responsibility to provide, some or all of the health care services required by paragraph (e), Medical evaluation.”

Components of Medical Evaluation Screening questionnaire Physical exam-at physician’s discretion Chest X-ray, pulmonary function tests, EKG at physician’s discretion

Follow-up Physical Examination Required for anyone who gives a positive response to any question 1-8 and at physician’s discretion As required by initial certification Will include any tests the physician determines are necessary

Information Needed By Physician Type of respirator used Frequency of use Duration of use Physical demands while wearing respirator Environmental conditions (heat, etc.) Other protective equipment worn

Physiologic Effects of Respirator Use Pulmonary effects: increased breathing resistance increased work of breathing decreased endurance decrease in exercise performance Cardiac effects: increased cardiac work increased heart rate increased blood pressure

Possible Psychological Effects of Respirator Use Claustrophobia Anxiety Hyperventilation

Potential Contraindications to Respirator Use Severe pulmonary disease Severe cardiac disease Uncontrolled hypertension Claustrophobia Facial abnormalities that prevent good fit

When to Medically Certify? Primary pre-use certification Routine periodic recertification Evaluation of users having problems

How often should recertification be performed? No definite standard or requirement Physician discretion Some recommendations: <35 years of age, every 4-5 years 35-45 years of age, every 2 years >45 years of age, every year

Step 5 – Provide Training Employers must provide effective training to employees who are required to use respirators.

Training Requirements Why the respirator is necessary Limitations and capabilities of the respirator How to inspect, put on and remove, use and check the seal Maintenance and storage Recognition of medical signs and symptoms that may limit or prevent effective use General requirements of the OSHA standard

Training, continued Training also includes education on such issues as: The mode of airborne infectious disease transmission Signs and symptoms of airborne infectious diseases Medical surveillance and therapy Site specific protocol

Training, continued Training must be provided prior to use, unless acceptable training has been provided by another employer within the past 12 months Retraining is required annually, and when: changes in the workplace or type of respirator render previous training obsolete there are inadequacies in the employee’s knowledge or use any other situation arises in which retraining appears necessary

Step 6 – Fit Testing Testing performed to determine if an employee can maintain an acceptable respiratory fit and seal Must be done prior to use; whenever a different respirator is worn; and at least annually thereafter Fit testing will be administered using an OSHA-accepted qualitative fit test or quantitative fit test protocol

When to Fit Test After subject is medically cleared for respirator use Before the subject wears the respirator in the workplace Minimum of once/year Facial changes Significant weight change Change of respirator size, make, model

Fit Testing The employee must be fit tested with the same make, model, style, and size of respirator that will be used

Fit Testing Qualitative fit test (QLFT): Quantitative fit test (QNFT): a pass/fail test to assess the adequacy of respirator fit that relies on the individual’s response to the test agent Quantitative fit test (QNFT): an assessment of the adequacy of respirator fit by numerically measuring the amount of leakage into the respirator

QLFT Sensitivity Test Subject is placed in hood without respirator Subject should open mouth and extend tongue Subject should breathe through mouth Apply 10 bulb squeezes of testing solution into the hood DO NOT spray testing solution into the subject’s face If subject does not taste fit test solution in 10 squeezes, apply another 10 squeezes If subject can’t taste solution by 30 squeezes, use another fit testing solution

QLFT Testing Solutions Denatonium benzoate (Bitrex) Saccharin Stannic Chloride No eating, drinking (water is allowed), gum or smoking for 15 minutes prior to test.

N95 Respirators Employees must be instructed how to put on, position, adjust, and remove respirators

QLFT Procedure Subject should wear respirator for 5 minutes prior to test Subject is placed into fit testing hood Apply same number of squeezes as in sensitivity test Every 30 seconds, introduce additional fit testing solution equal to one-half the number of sensitivity test squeezes

QLFT Exercises Normal breathing Deep breathing Moving head side to side – breathe in at far extreme Moving head up and down – breathe in at far extreme Speaking – read Rainbow Passage out loud Touching toes/jog in place

Quantitative Fit Testing Example: TSI PortaCount: Compares concentration of dust particles outside respirator to concentration of particles in respirator

Frequency of Fit Testing Prior to initial use Annually Whenever employee reports a problem

Factors Affecting Respirator Seal Facial hair Facial bone structure Dentures Facial scars Eyeglasses Excessive makeup

CDC Tuberculosis Guidelines The 1994 CDC Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Facilities* specify the following criteria for respirators for exposure to TB: ability to filter 1 micron in size in the unloaded state with a filter efficiency greater than 95% ability to be qualitatively or quantitatively fit tested in a reliable way to obtain face-seal leakage of less than 10% the minimal acceptable level of respirator protection for TB is the Type 95 respirator *http://www.cdc.gov/mmwr/preview/mmwrhtml/00035909.htm

Respirator Seal Respirators with tight-fitting facepieces must not be worn by employees who have facial hair or any condition that interferes with the face-to-facepiece seal Corrective glasses or goggles or other PPE must be worn in a manner that does not interfere with the face-to-facepiece seal Employees wearing tight-fitting respirators must perform a user seal check each time they put on the respirator using the procedures in Appendix B-1 or equally effective manufacturer’s procedures

Respirator Seal Requirements Facial hair, jewelry, and glasses must not come into contact with the respirator seal

User Seal Check Required An action conducted by the respirator user to determine if the respirator is properly seated to the face Required

When should an N95 respirator be changed? N95 respirators are disposable and cannot be cleaned If an N95 is used in the care of a patient on Contact Precautions, in addition to Standard Precautions (e.g., SARS, smallpox), it must be disposed of after each use N95s can be reused if used in the care of a tuberculosis patient check before putting on each time and replace if facepiece or head straps show any signs of damage or deterioration replace if facepiece is visibly dirty, splashed on, or becomes difficult to breathe through. replace in accordance with your agency’s infection control protocols.

Powered Air Purifying Respirators (PAPRs) Do not require fit testing, but medical evaluation still required Can be used by persons who are medically certified, but who cannot wear N95 respirators, e.g., persons with facial hair

Step 7 – Maintenance Program The employer must provide for the cleaning and disinfecting, storage, inspection, and repair of respirators used by employees

Step 8 - Program Evaluation Evaluations of the workplace must be conducted annually or as necessary to ensure effective implementation of the program Employees required to use respirators must be consulted regularly to assess their views on program effectiveness and to identify and correct any problems factors to be assessed include, but are not limited to: respirator fit (including effect on workplace performance) appropriate selection proper use proper maintenance

Recordkeeping Records of medical evaluations must be retained A record of fit tests must be established and retained until the next fit test is administered A written copy of the current program must be retained Written materials required to be retained must be made available upon request to affected employees and OSHA

Frequently Asked Questions Are temporary employees exempt from these requirements? No. Does a positive response to any question on the questionnaire mandate a physician encounter? No, the scope of the medical evaluation is left to the discretion of the physician. In some cases, an interview may provide the needed clarification. Who pays for the medical clearance? The employer.

To Sum Up… If you must use respirators… Help is available: Selection Training Administration Help is available: www.osha.gov www.cdc.gov/niosh