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

2. 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

3. 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

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

5. 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

6. 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

7. 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)

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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

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(withdrawn 12/31/2003, with grace period for implementation until July 1, 2004)

15. 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

16. 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

17. 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

18. 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

19. 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

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

21. 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

22. 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

24. 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)

25. 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)

27. 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

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

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

30. 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

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

32. 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

33. 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

34. 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

35. 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.”

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

37. 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

38. 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

39. 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

40. Possible Psychological Effects of Respirator Use
Claustrophobia
Anxiety
Hyperventilation

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

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

43. 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

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

45. 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

46. 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

47. 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

48. 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

49. 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

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

51. 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

52. 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

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

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

55. 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

56. 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

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

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

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

60. 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 *

61. 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

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

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

64. 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.

65. 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

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

67. 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

68. 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

69. 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.

70. To Sum Up… If you must use respirators… Help is available: Selection
Training
Administration
Help is available: