Respiratory Protection in Primary Care

Deborah Gold, MPH, CIHdgold@hq.dir.ca.gov

January, 2010

California Aerosol Transmissible Disease Standard

• Became effective August 5, 2009

• Applies in most health care environments, including primary care

• Title 8, California Code of Regulations, Section 5199 http://www.dir.ca.gov/Title8/5199.html

What is an Aerosol Transmissible Disease?

• A disease• That is transmitted by

aerosols (A gaseous suspension of fine solid or liquid particles)

Disease Agents Act at Different Places in the Respiratory Tract

Work settings covered by the ATD Standard

• Applies in health care, such as: – Hospitals– Long Term Health Care Facilities– Primary Care– Emergency Medical

• Applies in other high risk environments– Corrections– Homeless shelters– Drug treatment programs– First receiver– Laboratories

Droplet vs. Airborne

• CDC divides diseases between those believed spread by:– large droplets that hit mucous membranes– small particles that are inhaled

• The ATD standard adopts this system although there is substantial evidence that many “droplet” diseases have an airborne route of transmission

• Default for novel diseases is airborne• At this time, respirators are required for H1N1

Airborne Infectious Diseases

• Airborne spore release (e.g. anthrax) until decon

• Chickenpox (Varicella)• Highly pathogenic avian

influenza• Herpes zoster (varicella-

zoster, disseminated disease, per CDC)

• Measles (rubeola)

• Monkeypox

• SARS (Severe Acute Respiratory Syndrome)

• Smallpox• Tuberculosis

Cal/OSHA added:

• Novel or Unknown pathogen

• Any disease for which CDPH recommends AII

Some Droplet diseases

• Diptheria• Influenza• Meningococcal

disease • Mumps• Mycoplasma

pneumonia

• Pertussis• Plague (pneumonic)• Rubella• SARS• Viral hemorrhagic

fevers • Diseases for which

CDPH recommends droplet precautions

Is My Facility a “Referring Employer?”

• Screen persons for airborne infectious diseases (AirID).• Refer any person identified as a case or suspected case

of and Airborne Infectious Disease.• Not intend to provide further medical services to AirID

cases and suspected cases beyond first aid, initial treatment or screening and referral (no high hazard procedures on ATD cases)– Exception for novel pathogens – may maintain in facility if not

feasible to provide AII• Not provide transport, housing, or airborne infection

isolation to any person identified as an AirID case or suspected case, – Exceptions: may provide non-medical transport in the course of

a referral– May provide housing and isolation if AII not feasible for novel

pathogens

Most Primary Care Operations are probably “referring employers.”

It is up to your facility to determine what services you can provide safely to patients and adopt appropriate precautions. Higher levels of care, may place you under the full scope of the standard.

Referring Employers(subsection c)

• Source control, including early identification, cover cough, separation

• Screening procedures for airborne infectious diseases (AirIDs)– Medical– Non-medical (App. F)

• Have a system for timely referral (transfer) including getting information back

• Train employees• Respirators for:

– AirID cases not referred – AirID cases during initial treatment who are not using

source control, unless respirator use not feasible

Referring Employers(subsection c)

• Have a system for exposure incidents, including precautionary removal, and TB surveillance

• Provide additional CDC recommended vaccines to HCWs (effective 9/1/10)

• Provide seasonal flu vaccine to all employees with occupational exposure

• Record keeping

Protecting Health Care Workers in Non-Hospital Environments

• Early recognition of potential cases• Respiratory Hygiene• Separation of patients, limiting contact• Referral of patients needing airborne infection

isolation• Respiratory protection when appropriate• Hand hygiene, cleaning and disinfection of

surfaces• Vaccination and other medical follow-up• Training

Why Do We Need Respirators• When people breathe, talk, sing, cough, or

sneeze moist warm droplets are emitted• The droplets are of various sizes• The droplets quickly lose water and become

smaller• Droplets of up to 100 microns may remain

airborne long enough to be inhaled• Influenza receptors are located throughout the

respiratory tract• Respirators, but not surgical masks, seal to the

face and force air to pass through filtering media

When are Clinics required to use respirators

• While exposed to a patient who is a suspected or confirmed case of H1N1, TB or other AirID if patient not using source control measures, e.g.– if examining upper respiratory tract– if patient has bad cough and can’t use mask

• If high hazard procedures are performed on AirID patients (not referring employer)– As of September 1, 2010 higher levels of

protection are required for high hazard procedures

Respirators and Surgical Masks

Robert B. Lawrence, Matthew G. Duling, Catherine A. Calvert and Christopher C. Coffey , 'Comparison of Performance of Three Different Types of Respiratory Protection Devices', JOEH 3:9, 465 - 474

Respirators vs. Surgical Masks

Protection provided by device without fit-testing

Type of Device 5th percentile protection*

Elastomeric respirator 7.3

Filtering FacepieceN95

3.3

Surgical mask 1.2

*protection is outside concentration/inside concentration

Derrick JL, Gomersall CD. Protecting healthcare staff from severe acute respiratory syndrome:filtration capacity of multiple surgical masks. In Journal of Hospital Infection (2005)59, 365-368.

Multiple Surgical Masks

The Institute of Medicine Report

• Health care workers caring for H1N1 patients should use fit-tested N95 respirators or more effective respirators. – September 2009

Respirator Basics

• Respirator use in health care is regulated by Section 5199 and Section 5144 (federal 29 CFR 1910.134)

• Requirements– Reduction of hazard with engineering and

administrative controls– Written program and designated administrator– Hazard assessment – Selection of appropriate, NIOSH approved

respirators

Respirator Basics (cont)

• Medical Evaluation• Fit-testing (initial and periodic)• User procedures including seal check, cartridge

change, and procedures for IDLH• Procedures for storage, maintenance, cleaning

and disinfection• Training• Record Keeping• Program evaluation including employee

involvement

Respirator Selection

Air Purifying Respirators

• Air purifying respirators remove contaminants from the air being inhaled by the user– Conventional APR has negative pressure in the facepiece,

and is tight-fitting (generally)– Powered APR may have positive pressure, and may be a

hood, helmet, or tight-fitting facepiece

• N95 and other filters do not protect against gases and vapors

• APRs and PAPRs do not have an air source, and therefore can not be used in oxygen deficient atmospheres or if immediately dangerous to life or health (IDLH)

N95 RespiratorsThese respirators only reduce particulates, not gases or vapors

Elastomeric FacepiecesCartridges are available for particulates only, and for specific levels of gases or vapors.

Powered Air-PurifyingRespirators(PAPR)

Atmosphere Supplying Respirators

• Provide their own source of air (compressor, air tank, or portable air tank)

• Can be positive or (rarely) negative pressure

• Can be tight-fitting facepiece, or hood or helmet

• Generally do not filter air being exhaled

SCBA

Filtering Facepiece Respirators

• Nose bridge sealing surface– Adjustable or fixed

• Chin sealing surface• Straps and attachment• Also fluid resistant (“surgical

N95”)• Filter – N, R, or P, 95, 99 or

100• Exhalation Valve• Fold Flat• Latex free• Fit

Respirator Designs Vary

Respirator Designs Vary

Medical Issues with Respirator Use

• Increased resistance to air flow• Increased dead space volume

• Increased CO2

• Heat effects, particularly if used in conjunction with other PPE

• Physical work, ergonomics – particularly with SCBA

• Claustrophobia• Limits to communications

Confidential Medical Evaluations • Medical Evaluation must have the content of the

questionnaire in Section 5144, Appendix C– ATD standard permits the use of a shorter

questionnaire in Section 5199, Appendix B

• Questionnaire is available on many websites• Must be evaluated by a PLHCP who can order

additional tests• A “yes” answer to any specified question

requires “further evaluation”• No interval is specified for re-evaluation – the

PLHCP and employer should specify

Fit-testing

• The purpose of fit-testing is to ensure that a selected respirator will provide the required protection factor.

• Allowed fit-test methods are in Appendix A to Section 5144.

• Qualitative fit-tests use a challenge agent: – bitrex, saccharine, irritant smoke, or isoamyl acetate.

• Quantitative fit-tests measure leakage:– Generated aerosol, ambient aerosol, controlled

negative pressure.

Qualitative Fit Test

Quantitative Fit Test

Do N95’s need to be fit-tested?

1996 NIOSH laboratory study of 25 subjects with 21 models of N95s found

• Without fit-testing, the average protection factor for all subjects using a respirator was 3.

• By selecting out bad fits, using a fit-test, the average protection factor was 25

• Only four models passed a fit-test for the majority of participants. Three did not pass the fit-test for any participant. Laboratory Performance Evaluation of N95 Filtering Facepiece Respirators, 1996. MMWR Morb Mortal Wkly Rep. 1998 Dec 11;47(48):1045-9.

Effect of Fit-testing N95

Type Geometric mean without fit-test

5th %ilew/o /FT

5th %ile pass bitrex

5th %ile pass companion

Filtering facepiece

20.4 3.3 7.9 20.5

Source: Robert B. Lawrence, Matthew G. Duling, Catherine A. Calvert and Christopher C. Coffey , 'Comparison of Performance of Three Different Types of Respiratory Protection Devices', JOEH 3:9, 465 - 474

Additional Fit Tests

• To be provided if employee requests additional fit test

• If employee has weight gain or loss, facial changes (such as surgery or dental work) that may effect fit

• At least annually– Exception in Section 5199 for non-high

hazard, permits biennial until 1/1/2014 – Must provide Appendix G info in alternate

years

N95 User Procedures

• User seal check difficult to perform on filtering facepiece respirators

• Can not be used in atmospheres “immediately dangerous to life or health”

• Will not protect against gases or vapors, only particles (including mists)

• Change respirator (filtering facepiece) or cartridge when breathing becomes more difficult or if dirty, wet, etc.

What’s Wrong with this Picture?

• Respirators do not work if they do not seal to the face.

• Facial hair must not interfere with the seal.

• Straps must be directly seated on the head, in this case above and below the ear

N95 Maintenance, Storage, Inspection

• Every respirator should be inspected prior to putting it on, to make sure the straps are okay, it is not torn, deformed, dirty, etc.

• Generally filtering facepiece respirators used against infectious particles should be disposed each time they are removed

• If shortage prevents disposal, employer should have storage and re-donning procedures, including procedures for handling respirator to prevent contamination

• No respirator should be put on if it is torn, wet, dirty, or unable to form a facepiece seal

Initial and Annual TrainingRequired training elements

• Why the respirator is necessary and how improper fit, usage, or maintenance can compromise respirator protective effect ;

• Limitations and capabilities of the respirator• Emergency use and what to do it respirator

malfunctions • How to inspect, put on and remove, use, and

check the seals of the respirator; • maintenance and storage of the respirator; • Medical signs and symptoms that may limit or

prevent the effective use of respirators; and • General requirements of regulation

Program Review

• At least annual

• Consult with affected employees

Record Keeping• Medical evaluations per 3204

• Most recent fit-test

• Appendix G to 5199

• Current respirator program made available

Help with Respirators

• Cal/OSHA consultation:1(800) 963-9424 • California Association of Health Facilities,

model program http://www.cahfdownload.com/cahf/dpp/CAHF_ModelRespiratoryProtectionProgram.pdf

• Occupational Health Branch train-the-trainer programs -- TBA

• Respirator manufacturers and distributors

• Workers’ comp insurance carriers

Find Cal/OSHA on the Web

• Cal/OSHA ATD standard: – http://www.dir.ca.gov/Title8/5199.html

• Advisory committee webpage:– http://www.dir.ca.gov/dosh/DoshReg/advisory

_committee.html

• Respiratory protection regulation– http://www.dir.ca.gov/Title8/5144.html

• Respiratory Protection in the Workplace– http://www.dir.ca.gov/dosh/dosh_publications/

respiratory.pdf